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31998L0095
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1998
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Council Directive 98/95/EC of 14 December 1998 amending, in respect of the consolidation of the internal market, genetically modified plant varieties and plant genetic resources, Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 66/403/EEC, 69/208/EEC, 70/457/EEC and 70/458/EEC on the marketing of beet seed, fodder plant seed, cereal seed, seed potatoes, seed of oil and fibre plants and vegetable seed and on the common catalogue of varieties of agricultural plant species
Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
(1) Whereas, for the reasons given below, the following Directives on the marketing of seed and propagating material should be amended:
- Council Directive 66/400/EEC of 14 June 1966 on the marketing of beet seed (4),
- Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (5),
- Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (6),
- Council Directive 66/403/EEC of 14 June 1966 on the marketing of seed potatoes (7),
- Council Directive 69/208/EEC of 30 June 1969 on the marketing of seed of oil and fibre plants (8),
- Council Directive 70/457/EEC of 29 September 1970 on the common catalogue of varieties of agricultural plant species (9),
- Council Directive 70/458/EEC of 29 September 1970 on the marketing of vegetable seed (10);
(2) Whereas, in the context of the consolidation of the internal market, it is necessary to amend or repeal certain provisions of the said Directives in order to remove any actual or potential barriers to trade which may hinder the free movement of seeds within the Community; whereas, to this end, any possibilities for Member States to derogate unilaterally from the provisions of the said Directives should be removed;
(3) Whereas, for the same reasons, the scope of the said Directives should be enlarged to cover also the production of seed, with a view to marketing;
(4) Whereas it should be possible under specified conditions to place on the market bred seed of generations prior to basic seed and seed as grown;
(5) Whereas Member States making use of derogations still permitted under the said Directives should assist each other administratively as regards inspection; whereas the use of such derogations is without prejudice to Article 7a of the Treaty;
(6) Whereas the conditions under which Member States may authorise small quantities of seed for tests, scientific purposes or selection work to be placed on the market should be determined by the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry;
(7) Whereas, in certain cases, the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry should determine whether packages of basic or certified seed should bear a supplier's label;
(8) Whereas, in the case of certain species of seed covered by Directive 66/401/EEC, it should be permitted to certify seed of the first and second generations;
(9) Whereas, in the case of certain species of seed covered by Directive 66/402/EEC, Member States should be permitted to restrict the certification of seed to that of the first generation;
(10) Whereas the minimum size of seed potatoes which may be placed on the market under Directive 66/403/EEC should be changed and a legal basis established to enable the minimum size of the square mesh used to measure the size of seed potatoes to be altered in the future; whereas a provision in respect of separation of seed potatoes from other potatoes for plant health reasons should be introduced;
(11) Whereas seed covered by Directive 70/457/EEC should be freely marketable within the Community two months after publication in the common catalogue;
(12) Whereas the conditions under which mixtures of certain species covered by Directive 70/458/EEC may be placed on the market should be determined in accordance with the procedure of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry; whereas in respect of the same Directive the provisions on the renewal of the official acceptance of certain varieties should be adapted in order to avoid disturbing current practice in marking packages;
(13) Whereas, in the light of experience, it is useful to clarify and update certain provisions of the abovementioned Directives;
(14) Whereas, in the light of scientific and technical developments, it is now possible to breed varieties through genetic modification; whereas, therefore, when determining whether to accept genetically modified varieties within the meaning of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (11) under Directives 70/457/EEC and 70/458/EEC, Member States should have regard to any risk related to their deliberate release into the environment; whereas, furthermore, a legal basis to establish the conditions under which such genetically modified varieties may be marketed should be introduced;
(15) Whereas the marketing of novel foods and novel food ingredients is regulated at Community level by Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 (12); whereas, therefore, it is appropriate for Member States also to have regard to any food health risks when determining whether to accept varieties under Directives 70/457/EEC and 70/458/EEC; whereas, furthermore, a legal basis should be established to take account of these developments;
(16) Whereas, in the light of scientific and technical developments, a legal basis to establish the conditions under which chemically treated seed may be marketed should be introduced;
(17) Whereas it is essential to ensure that plant genetic resources are conserved; whereas a legal basis to that end should be introduced to permit, within the framework of legislation on the seed trade, the conservation, by use in situ, of varieties threatened with genetic erosion;
(18) Whereas a legal basis to establish conditions under which seed suitable for organic growing may be marketed should be introduced;
(19) Whereas, in order to facilitate the introduction of the measures envisaged in this Directive, certain transitional measures should be introduced,
Article 1
Directive 66/400/EEC is hereby amended as follows:
1. Article 1 shall be replaced by the following:
'Article 1
This Directive shall apply to the production with a view to marketing, and to the marketing of, beet seed within the Community.`;
2. the following Article shall be added after Article 1:
'Article 1a
For the purposes of this Directive "marketing" shall mean the sale, holding with a view to sale, offer for sale and any disposal, supply or transfer aimed at commercial exploitation of seed to third parties, whether or not for consideration.
Trade in seed not aimed at commercial exploitation of the variety, such as the following operations, shall not be regarded as marketing:
- the supply of seed to official testing and inspection bodies,
- the supply of seed to providers of services for processing or packaging, provided the provider of services does not acquire title to seed thus supplied.
The supply of seed under certain conditions to providers of services for the production of certain agricultural raw materials, intended for industrial purposes, or seed propagation for that purpose, shall not be regarded as marketing, provided the provider of services does not acquire title to either the seed thus supplied or the product of the harvest. The supplier of seed shall provide the Certification Authority with a copy of the relevant parts of the contract made with the provider of services and this shall include the standards and conditions currently met by the seed provided.
The conditions for the application of this provision shall be determined in accordance with the procedure laid down in Article 21.`;
3. Article 3(1) shall be replaced by the following:
'Member States shall provide that beet seed may not be placed on the market unless it has been officially certified as "basic seed" or "certified seed".`;
4. Article 3(3) shall be repealed;
5. the following Article shall be inserted after Article 3:
'Article 3a
Notwithstanding Article 3(1), Member States shall provide that
- bred seed of generations prior to basic seed, and
- seed as grown, marketed for processing, provided that the identity of the seed is ensured,
may be placed on the market.`;
6. the following subparagraph shall be added at the end of Article 4:
'Member States making use of the derogation provided for in either subparagraph (a) or (b) shall assist each other administratively as regards control.`;
7. the following Article shall be inserted after Article 4:
'Article 4a
1. Notwithstanding Article 3(1), Member States may authorise producers in their own territory to place on the market:
(a) small quantities of seed for scientific purposes or selection work;
(b) appropriate quantities of seed for other test or trial purposes, provided it belongs to varieties for which an application for entry in the catalogue has been submitted in the Member State in question.
In the case of genetically modified material, such authorisation may be granted only if all appropriate measures have been taken to avoid adverse effects on human health and the environment. For the environmental risk assessment to be carried out in this respect, the provisions of Article 7(4) of Directive 70/457/EEC shall apply accordingly.
2. The purposes for which the authorisations referred to in paragraph 1(b) may be given, the provisions relating to the marking of packages, and the quantities and the conditions under which Member States may grant such authorisation shall be determined in accordance with the procedure laid down in Article 21.
3. Authorisations granted before the date of adoption of this Directive by Member States to producers in their own territory for the purposes set out in paragraph 1 shall remain in force pending determination of the provisions referred to in paragraph 2. Thereafter, all such authorisations shall respect the provisions established in accordance with paragraph 2.`;
8. Article 10(4) shall be repealed;
9. Article 11(2) shall be repealed;
10. in Article 11a(1)(a) and (b), the words 'the label shall be blue in colour` shall be replaced by the words 'the label shall be white in colour for basic seed and blue in colour for certified seed`;
11. in Article 11b, the word 'certified` shall be deleted;
12. in Article 11c, the word 'certified` shall be deleted;
13. Article 12(1) shall be replaced by the following:
'1. In accordance with the procedure laid down in Article 21, it may be provided that, in cases other than those already provided for in this Directive, packages of basic or certified seed of any kind shall bear a supplier's label (which may either be a label separate from the official label or take the form of suppliers' information printed on the package itself). The particulars to be provided on any such label shall also be established in accordance with the procedure laid down in Article 21.`;
14. the following Article shall be added after Article 12:
'Article 12a
In the case of seed of a variety which has been genetically modified, any label or document, official or otherwise, which is affixed to or accompanies the seed lot, under the provisions of this Directive, shall clearly indicate that the variety has been genetically modified.`;
15. Article 14(1) shall be replaced by the following:
'1. Member States shall ensure that seed which is placed on the market under the provisions of this Directive, whether mandatory or discretionary, is not subject to any marketing restrictions as regards its characteristics, examination requirements, marking and sealing other than those laid down in this or any other Directive.`;
16. Article 14(2)(b) shall be repealed;
17. Article 14(2)(c) shall be repealed;
18. Article 14(3) shall be repealed;
19. the following Article shall be inserted after Article 14:
'Article 14a
The conditions under which bred seed of generations prior to basic seed may be placed on the market under the first indent of Article 3a shall be as follows:
(a) it must have been officially inspected by the competent certification authority in accordance with the provisions applicable to the certification of basic seed;
(b) it must be packed in accordance with this Directive, and
(c) the packages must bear an official label giving at least the following particulars:
- certification authority and Member State or their distinguishing abbreviation,
- lot reference number,
- month and year of sealing, or
- month and year of the last official sampling for the purposes of certification,
- species, indicated at least in Roman characters, under its botanical name, which may be given in abridged form and without the authors' names, or under its common name, or both; indication whether sugar beet or fodder beet,
- variety, indicated at least in Roman characters,
- the description "pre-basic seed",
- number of generations preceding seed of the category "certified seed".
The label shall be white with a diagonal violet line.`;
20. Article 15(2) shall be replaced by the following:
'2. Beet seed which has been harvested in the Community and which is intended for certification in accordance with paragraph 1 shall:
- be packed and labelled with an official label satisfying the conditions laid down in Annex IV(A) and (B), in accordance with Article 10(1), and
- be accompanied by an official document satisfying the conditions laid down in Annex IV(C).
The provisions in the first subparagraph on packing and labelling may be waived if the authorities responsible for field inspection, those drawing up the documents for the certification of seeds which have not been definitively certified and those responsible for certification are the same, or if they agree on exemption.`;
21. Article 17 shall be replaced by the following:
'Article 17
1. In order to remove any temporary difficulties in the general supply of basic or certified seed that occur in the Community and cannot be otherwise overcome, it may be decided in accordance with the procedure laid down in Article 21 that Member States shall permit, for a specified period, the marketing throughout the Community in quantities necessary to resolve the supply difficulties of seed of a category subject to less stringent requirements, or of seed of a variety not included in the "Common Catalogue of Varieties of Agricultural Plant Species" or in the national catalogues of varieties of the Member States.
2. For a category of seed of any given variety, the official label shall be that provided for the corresponding category; for seed of varieties not included in the abovementioned catalogues the colour of the official label shall be brown. The label shall always state that the seed in question is of a category satisfying less stringent requirements.
3. Rules for the application of paragraph 1 may be adopted in accordance with the procedure laid down in Article 21.`;
22. Article 19(1) shall be replaced by the following:
'1. Member States shall ensure that official inspections are carried out in relation to the marketing of beet seed, at least by random checks, to verify compliance with the requirements and conditions of this Directive.`;
23. Article 19(2) shall be replaced by the following:
'2. Without prejudice to the free movement of seed within the Community, Member States shall take all necessary measures to ensure that they are supplied with the following particulars during the marketing of quantities exceeding two kilograms of seed imported from third countries:
(a) species;
(b) variety;
(c) category;
(d) country of production and official inspection authority;
(e) country of dispatch;
(f) importer;
(g) quantity of seed.
The manner in which these particulars are to be presented may be determined in accordance with the procedure laid down in Article 21.`;
24. the following Article shall be inserted after Article 22:
'Article 22a
1. Specific conditions may be established in accordance with the procedure laid down in Article 21 to take account of developments in the areas of:
(a) conditions under which chemically treated seed may be marketed;
(b) conditions under which seed may be marketed in relation to the conservation in situ and the sustainable use of plant genetic resources, including seed mixtures of species which also include species listed in Article 1 of Council Directive 70/457/EEC, and are associated with specific natural and semi-natural habitats and are threatened by genetic erosion;
(c) conditions under which seed suitable for organic production may be marketed.
2. The specific conditions referred to in paragraph 1 shall include in particular the following points:
(i) in the case of (b), the seed of these species shall be of a known provenance approved by the appropriate Authority in each Member State for marketing the seed in defined areas;
(ii) in the case of (b), appropriate quantitative restrictions.`;
25. in Annex III(B)(8), the words 'certified seed` shall be replaced by the word 'category`.
Article 2
Directive 66/401/EEC is hereby amended as follows:
1. Article 1 shall be replaced by the following:
'Article 1
This Directive shall apply to the production with a view to marketing, and to the marketing, of fodder plant seed within the Community.`;
2. the following Article shall be inserted after Article 1:
'Article 1a
For the purposes of this Directive "marketing" shall mean the sale, holding with a view to sale, offer for sale and any disposal, supply or transfer aimed at commercial exploitation of seed to third parties, whether or not for consideration.
Trade in seed not aimed at commercial exploitation of the variety, such as the following operations, shall not be regarded as marketing:
- the supply of seed to official testing and inspection bodies,
- the supply of seed to providers of services for processing or packaging, provided the provider of services does not acquire title to seed thus supplied.
The supply of seed under certain conditions to providers of services for the production of certain agricultural raw materials, intended for industrial purposes, or seed propagation for that purpose, shall not be regarded as marketing, provided the provider of services does not acquire title to either the seed thus supplied or the product of the harvest. The supplier of seed shall provide the Certification Authority with a copy of the relevant parts of the contract made with the provider of services and this shall include the standards and conditions currently met by the seed provided.
The conditions for the application of this provision shall be determined in accordance with the procedure laid down in Article 21.`;
3. Article 2(1)(C) shall be replaced by the following:
'C. Certified seed: seed of all the species listed under A other than Lupinus spp., Pisum sativum, Vicia spp. and Medicago sativa:
(a) which has been produced directly from basic seed or, if the breeder so requests, from seed of a generation prior to basic seed which has been found by official examination to satisfy the conditions laid down in Annexes I and II for basic seed;
(b) which is intended for purposes other than the production of seed;
(c) which, subject to of Article 4(b), satisfies the conditions laid down in Annexes I and II for certified seed; and
(d) which has been found by official examination to satisfy the abovementioned conditions.`;
4. the following points shall be inserted after Article 2(1)(C):
'Ca. Certified seed, first generation (Lupinus spp., Pisum sativum, Vicia spp. and Medicago sativa) seed:
(a) which has been produced directly from basic seed or, if the breeder so requests, from seed of a generation prior to basic seed which can satisfy and has been found by official examination to satisfy the conditions laid down in Annexes I and II for basic seed;
(b) which is intended either for the production of seed of the category "certified seed, second generation" or for purposes other than the production of seed of fodder plants;
(c) which, subject to Article 4(b), satisfies the conditions laid down in Annexes I and II for certified seed; and
(d) which has been found by official examination to satisfy the abovementioned conditions.
Cb. Certified seed, second generation (Lupinus spp., Pisum sativum, Vicia spp. and Medicago sativa) seed:
(a) which has been produced directly from basic seed, from certified seed of the first generation or, if the breeder so requests, from seed of a generation prior to basic seed which can satisfy and has been found by official examination to satisfy the conditions laid down in Annexes I and II for basic seed;
(b) which is intended for purposes other than the production of seed of fodder plants;
(c) which, subject to Article 4(b), satisfies the conditions laid down in Annexes I and II, for certified seed; and
(d) which has been found by official examination to satisfy the abovementioned conditions.`;
5. in Article 2(1)(G), the words 'basic seed,` shall be inserted before the words 'certified seed`;
6. Article 2(1)(c) shall be repealed;
7. in Article 3(1), the words 'and unless it satisfies the conditions laid down in Annex II` shall be deleted;
8. in Article 3(2) the words 'and unless it satisfies the conditions laid down in Annex II` shall be deleted;
9. Article 3(5) shall be repealed;
10. the following Article shall be inserted after Article 3:
'Article 3a
Notwithstanding Article 3(1), Member States shall provide that
- bred seed of generations prior to basic seed, and
- seed as grown, marketed for processing, provided that the identity of the seed is ensured,
may be placed on the market.`;
11. the following subparagraph shall be added at the end of Article 4:
'Member States making use of the derogation provided for in either subparagraph (a) or (b) shall assist each other administratively as regards inspection.`;
12. the following Article shall be inserted after Article 4:
'Article 4a
1. Notwithstanding Article 3(1), Member States may authorise producers in their own territory to place on the market:
(a) small quantities of seed for scientific purposes or selection work;
(b) appropriate quantities of seed for other test or trial purposes, provided it belongs to varieties for which an application for entry in the catalogue has been submitted in the Member State in question.
In the case of genetically modified material, such authorisation may be granted only if all appropriate measures have been taken to avoid adverse effects on human health and the environment. For the environment risk assessment to be carried out in this respect, the provisions of Article 7(4) of Directive 70/457/EEC shall apply accordingly.
2. The purposes for which the authorisations referred to in paragraph 1(b) may be given, the provisions relating to the marking of packages, and the quantities and the conditions under which Member States may grant such authorisation shall be determined in accordance with the procedure laid down in Article 21.
3. Authorisations granted before the date of adoption of this Directive by Member States to producers in their own territory for the purposes set out in paragraph 1 shall remain in force pending determination of the provisions referred to in paragraph 2. Thereafter, all such authorisations shall respect the provisions established in accordance with paragraph 2.`;
13. the following Article shall be inserted after Article 5:
'Article 5a
Member States may restrict the certification of seed of Lupinus spp., Pisum sativum, Vicia spp. and Medicago sativa to certified seed of the first generation.`;
14. Article 9(4) shall be repealed;
15. Article 10(2) shall be repealed;
16. Article 10b shall be replaced by the following:
'Article 10b
Member States may provide that, on request, small EC B packages of seed shall be sealed and marked officially or under official supervision in accordance with Article 9(1) and Article 10.`;
17. Article 11 shall be replaced by the following:
'Article 11
1. In accordance with the procedure laid down in Article 21 it may be provided that Member States may require that, in cases other than those provided for in this Directive, packages of basic seed, certified seed or commercial seed shall bear a supplier's label (which may either be a label separate from the official label or take the form of suppliers' information printed on the package itself) or that seed lots complying with the special conditions concerning the presence of Avena fatua, laid down in accordance with the procedure provided for in Article 21, should be accompanied by an official certificate attesting compliance with those conditions.
2. The particulars to be provided on any such label shall also be established in accordance with the procedure laid down in Article 21.`;
18. the following Article shall be inserted after Article 11:
'Article 11a
In the case of seed of a variety which has been genetically modified, any label or document, official or otherwise, which is affixed to or accompanies the seed lot, under the provisions of this Directive, shall clearly indicate that the variety has been genetically modified.`;
19. Article 13(1) shall be deleted and paragraph 2 replaced by the following:
'1. Member States shall specify that seed in mixtures of various genera, species or varieties may be placed on the market:
- if it is not intended for use as fodder plants, in which case the mixtures may contain seeds of fodder plants and seeds of plants which are not fodder plants within the meaning of this Directive;
- if it is intended for use as fodder plants, in which case the mixture may contain seeds of plant species listed in Directives 66/401/EEC, 66/402/EEC, 69/208/EEC or 70/458/EEC, with the exception of the varieties mentioned in Article 4(2)(a) of Directive 70/457/EEC;
- if it is intended for use in the preservation of the natural environment in the context of the conservation of genetic resources referred to in Article 22a(b), in which case the mixtures may contain seeds of fodder plants and seeds of plants which are not fodder plants within the meaning of the Directive.
In the cases provided for in the first and second indents, the various components of the mixtures must, in so far as they belong to one of the plant species listed in Directives 66/401/EEC, 66/402/EEC, 69/208/EEC and 70/458/EEC, comply, before mixing, with the marketing regulations applicable to them.
Other conditions, including labelling the technical approval of firms producing seed mixtures, the inspection of the production of mixtures, and the sampling of primary ingredient lots and of finished mixtures, shall be determined in accordance with the procedure laid down in Article 21.
In the case of the third indent, the conditions under which such mixtures may be marketed shall be determined in accordance with the procedure laid down in Article 21.`;
20. the last subparagraph of Article 13(3) shall be deleted;
21. Article 14(1) shall be replaced by the following:
'1. Member States shall ensure that seed which is placed on the market under the provisions of this Directive, whether mandatory or discretionary, is not subject to any marketing restrictions as regards its characteristics, examination requirements, marking and sealing other than those laid down in this or any other Directive.`;
22. Article 14(2) shall be repealed;
23. Article 14(3) shall be repealed;
24. the following Article shall be inserted after Article 14:
'Article 14a
The conditions under which bred seed of generations prior to basic seed may be placed on the market under the first indent of Article 3a shall be as follows:
(a) it must have been officially inspected by the competent certification authority in accordance with the provisions applicable to the certification of basic seed;
(b) it must be packed in accordance with this Directive; and
(c) the packages must bear an official label giving at least the following particulars:
- certification authority and Member State or their distinguishing abbreviation,
- lot reference number,
- month and year of sealing, or
- month and year of the last official sampling for the purposes of certification,
- species, indicated at least under its botanical name, which may be given in abridged form and without the authors' names, in Roman characters,
- variety, indicated at least in Roman characters,
- the description "pre-basic seed",
- number of generations preceding seed of the category "certified seed", or "certified seed of the first generation".
The label shall be white with a diagonal violet line.`;
25. Article 15(2) shall be replaced by the following:
'2. Fodder plant seed which has been harvested in the Community and which is intended for certification in accordance with paragraph 1 shall:
- be packed and labelled with an official label satisfying the conditions laid down in Annex V(A) and (B), in accordance with Article 9(1); and
- be accompanied by an official document satisfying the conditions laid down in Annex V(C).
The provisions in the first subparagraph on packing and labelling may be waived if the authorities responsible for field inspection, those drawing up the documents for the certification of seeds which have not been definitively certified and those responsible for certification are the same, or if they agree on exemption.`;
clearly indicate that the variety has been genetically modified.`;
26. Article 17 shall be replaced by the following:
'Article 17
1. In order to remove any temporary difficulties in the general supply of basic, certified or commercial seed that occur in the Community and cannot be otherwise overcome, it may be decided in accordance with the procedure laid down in Article 21 that Member States shall permit, for a specified period, the marketing throughout the Community in quantities necessary to resolve supply difficulties of seed of a category subject to less stringent requirements, or of seed of a variety not included in the Common Catalogue of Varieties of Agricultural Plant Species or in the national catalogues of varieties of the Member States.
2. For a category of seed of any given variety, the official label shall be that provided for the corresponding category; for seed of varieties not included in the abovementioned catalogues, the official label shall be that provided for commercial seed. The label shall always state that the seed in question is of a category satisfying less stringent requirements.
3. Rules for the application of paragraph 1 may be adopted in accordance with the procedure laid down in Article 21.`;
27. Article 19(1) shall be replaced by the following:
'1. Member States shall ensure that official inspections are carried out in relation to the marketing of fodder plant seed, at least by random checks, to verify compliance with the requirements and conditions of this Directive.`;
28. Article 19(2) shall be replaced by the following:
'2. Without prejudice to the free movement of seed within the Community, Member States shall take all necessary measures to ensure that they are supplied with the following particulars during the marketing of quantities exceeding two kilograms of seed imported from third countries:
(a) species;
(b) variety;
(c) category;
(d) country of production and official inspection authority;
(e) country of dispatch;
(f) importer;
(g) quantity of seed.
The manner in which these particulars are to be presented may be determined in accordance with the procedure laid down in Article 21.`;
29. the following Article shall be inserted after Article 22:
'Article 22a
1. Specific conditions may be established in accordance with the procedure laid down in Article 21 to take account of developments in the areas of:
(a) conditions under which chemically treated seed may be marketed;
(b) conditions under which seed may be marketed in relation to the conservation in situ and the sustainable use of plant genetic resources, including seed mixtures of species which also include species listed in Article 1 of Council Directive 70/457/EEC, and are associated with specific natural and semi-natural habitats and are threatened by genetic erosion;
(c) conditions under which seed suitable for organic production may be marketed.
2. The specific conditions referred to in paragraph 1 shall include in particular the following points:
(i) in the case of (b), the seed of these species shall be of a known provenance approved by the appropriate Authority in each Member State for marketing the seed in defined areas;
(ii) in the case of (b), appropriate quantitative restrictions.`;
30. in the first indent of Annex II(I)(1), the words ", Brassica napus var. napobrassica and Brassica oleracea convar. acephala" shall be added after the words 'Annex I`;
31. in the second indent of Annex II(I)(1), the words "Brassica napus var. napobrassica Brassica oleracea convar. acephala" shall be deleted;
32. in Annex IV(B)(a)(8), the words "certified seed" shall be replaced by the word "category".
Article 3
Directive 66/402/EEC is hereby amended as follows:
1. Article 1 shall be replaced by the following:
'Article 1
This Directive shall apply to the production with a view to marketing, and to the marketing, of cereal seed within the Community.`;
2. the following Article shall be added after Article 1:
'Article 1a
For the purposes of this Directive "marketing" shall mean the sale, holding with a view to sale, offer for sale and any disposal, supply or transfer aimed at commercial exploitation of seed to third parties, whether or not for consideration.
Trade in seed not aimed at commercial exploitation of the variety, such as the following operations, shall not be regarded as marketing:
- the supply of seed to official testing and inspection bodies;
- the supply of seed to providers of services for processing or packaging, provided the provider of services does not acquire title to seed thus supplied.
The supply of seed under certain conditions to providers of services for the production of certain agricultural raw materials, intended for industrial purposes, or seed propagation for that purpose, shall not be regarded as marketing, provided the provider of services does not acquire title to either the seed thus supplied or the product of the harvest. The supplier of seed shall provide the Certification Authority with a copy of the relevant parts of the contract made with the provider of services and this shall include the standards and conditions currently met by the seed provided.
The conditions for the application of this provision shall be determined in accordance with the procedure laid down in Article 21.`;
3. Article 2(1d) shall be repealed;
4. Article 3(1) shall be replaced by the following:
'1. Member States shall provide that cereal seed may not be placed on the market unless it has been officially certified as "basic seed", "certified seed", "certified seed, first generation" or "certified seed, second generation".`;
5. in Article 3(2), the words 'and marketing` shall be deleted;
6. Article 3(4) shall be repealed;
7. the following Article shall be inserted after Article 3:
'Article 3a
Notwithstanding Article 3(1), Member States shall provide that:
- bred seed of generations prior to basic seed, and
- seed as grown, marketed for processing, provided that the identity of the seed is ensured,
may be placed on the market.`;
8. Article 4(2) shall be repealed;
9. Article 4(3) shall be repealed;
10. the following paragraph shall be added to Article 4:
'4. Member States making use of the derogation provided for in either subparagraph 1(a) or 1(b) shall assist each other administratively as regards inspection.`;
11. the following Article shall be inserted after Article 4:
'Article 4a
1. Notwithstanding Article 3(1), Member States may authorise producers in their own territory to place on the market:
(a) small quantities of seed for, scientific purposes or selection work;
(b) appropriate quantities of seed for other test or trial purposes, provided it belongs to varieties for which an application for entry in the catalogue has been submitted in the Member State in question.
In the case of genetically modified material, such authorisation may be granted only if all appropriate measures have been taken to avoid adverse effects on human health and the environment. For the environmental risk assessment to be carried out in this respect, the provisions of Article 7(4) of Directive 70/457/EEC shall apply accordingly.
2. The purposes for which the authorities referred to in paragraph 1(b) may be given, the provisions relating to the marking of packages, and the quantities and the conditions under which Member States may grant such authorisation shall be determined in accordance with the procedure laid down in Article 21.
3. Authorisations granted before the date of adoption of this Directive by Member States to producers in their own territory for the purposes set out in paragraph 1 shall remain in force pending determination of the provisions referred to in paragraph 2. Thereafter, all such authorisations shall respect the provisions established in accordance with paragraph 2.`;
12. the following Article shall be inserted after Article 5:
'Article 5a
Member States may restrict the certification of seed of oats, barley, rice and wheat to that of certified seed of the first generation.`;
13. in Article 9(3) the words 'sealed in their own territory. Conditions relating to these exceptions may be determined in accordance with the procedure laid down in Article 21` shall be added after the words 'small packages`;
14. Article 10(2) shall be replaced by the following:
'2. Member States may provide for exceptions to paragraph 1 in the case of small packages sealed in their own territory. Conditions relating to these exceptions may be determined in accordance with the procedure laid down in Article 21.`;
15. Article 11 shall be replaced by the following:
'Article 11
In accordance with the procedure laid down in Article 21, it may be provided that, in cases other than those already provided for in this Directive, packages of basic or certified seed of any kind shall bear a supplier's label (which may either be a label separate from the official label or take the form of suppliers' information printed on the package itself). The particulars to be provided on any such label shall also be established in accordance with the procedure laid down in Article 21.`;
16. the following paragraph shall be added to Article 11:
'3. This Directive shall not affect the right of Member States to require that seed lots complying with the special conditions concerning the presence of Avena fatua laid down in accordance with the procedure provided for in Article 21 shall be accompanied by an official certificate attesting compliance with those conditions.`;
17. the following Article shall be inserted after Article 11:
'Article 11a
In the case of seed of a variety which has been genetically modified, any label or document, official or otherwise, which is affixed to or accompanies the seed lot, under the provisions of this Directive, shall clearly indicate that the variety has been genetically modified.`;
18. in Article 13(1), the word 'may` shall be replaced by the word 'shall`;
19. in Article 13(2), the word 'may` shall be replaced by the word 'shall`;
20. the following paragraph shall be added after Article 13(2):
'2a. The specific conditions under which such mixtures may be marketed shall be determined in accordance with the procedure laid down in Article 21.`;
21. Article 14(1) shall be replaced by the following:
'1. Member States shall ensure that seed which is placed on the market under the provisions of this Directive, whether mandatory or discretionary, is not subject to any marketing restrictions as regards its characteristics, examination requirements, marking and sealing other than those laid down in this or any other Directive.`;
22. Article 14(2) shall be repealed;
23. Article 14(3) shall be repealed;
24. the following Article shall be inserted after Article 14:
'Article 14a
The conditions under which bred seed of generations prior to basic seed may be placed on the market under the first indent of Article 3a, shall be as follows:
(a) it must have been officially inspected by the competent certification authority in accordance with the provisions applicable to the certification of basic seed;
(b) it must be packed in accordance with the provisions of this Directive; and
(c) the packages must bear an official label giving at least the following particulars:
- certification authority and Member State or their distinguishing abbreviation,
- lot reference number,
- month and year of sealing, or
- month and year of the last official sampling for the purposes of certification,
- species, indicated at least under its botanical name, which may be given in abridged form and without the authors' names, in Roman characters,
- variety, indicated at least in Roman characters,
- the description "pre-basic seed",
- number of generations preceding seed of the categories "certified seed" or "certified seed of the first generation".
The label shall be white with a diagonal violet line.`;
25. Article 15(2) shall be replaced by the following:
'2. Cereal seed which has been harvested in the Community, and which is intended for certification in accordance with paragraph 1, shall:
- be packed and labelled with an official label satisfying the conditions laid down in Annex V(A) and (B), in accordance with Article 9(1), and
- be accompanied by an official document satisfying the conditions laid down in Annex V(C).
The provisions in the first subparagraph on packing and labelling may be waived if the authorities responsible for field inspection, those drawing up the documents for the certification of seeds which have not been definitively certified and those responsible for certification are the same, or if they agree on exemption.`;
26. Article 17 shall be replaced by the following:
'Article 17
1. In order to remove any temporary difficulties in the general supply of basic or certified seed that occur in the Community and cannot be otherwise overcome, it may be decided in accordance with the procedure laid down in Article 21 that Member States shall permit, for a specified period, the marketing throughout the Community in quantities necessary to resolve the supply difficulties of seed of a category subject to less stringent requirements, or of seed of a variety not included in the Common Catalogue of Varieties of Agricultural Plant Species or in the national catalogues of varieties of the Member States.
2. For a category of seed of any given variety, the official label shall be that provided for the corresponding category; for seed of varieties not included in the abovementioned catalogues the colour of the official label shall be brown. The label shall always state that the seed in question is of a category satisfying less stringent requirements.
3. Rules for the application of paragraph 1 may be adopted in accordance with the procedure laid down in Article 21.`;
27. Article 19(1) shall be replaced by the following:
'1. Member States shall ensure that official inspections are carried out in relation to the marketing, at least by random checks, to verify compliance with the requirements of this Directive.`;
28. Article 19(2) shall be replaced by the following:
'2. Without prejudice to the free movement of seed within the Community, Member States shall take all necessary measures to ensure that they are supplied with the following particulars during the marketing of quantities exceeding two kilograms of seed imported from third countries:
(a) species;
(b) variety;
(c) category;
(d) country of production and official inspection authority;
(e) country of dispatch;
(f) importer;
(g) quantity of seed.
The manner in which these particulars are to be presented may be determined in accordance with the procedure laid down in Article 21.`;
29. the following Article shall be inserted after Article 22:
'Article 22a
1. Specific conditions may be established in accordance with the procedure laid down in Article 21 to take account of developments in the areas of:
(a) conditions under which chemically treated seed may be marketed;
(b) conditions under which seed may be marketed in relation to the conservation in situ and the sustainable use of plant genetic resources, including seed mixtures of species which also include species listed in Article 1 of Council Directive 70/457/EEC, and are associated with specific natural and semi-natural habitats and are threatened by genetic erosion;
(c) conditions under which seed suitable for organic production may be marketed.
2. The specific conditions referred to in paragraph 1 shall include in particular the following points:
(i) in the case of (b), the seed of these species shall be of a known provenance approved by the appropriate authority in each Member State for marketing the seed in defined areas;
(ii) in the case of (b), appropriate quantitative restrictions.`
Article 4
Directive 66/403/EEC is hereby amended as follows:
1. Article 1 shall be replaced by the following:
'Article 1
This Directive shall apply to the production with a view to marketing, and to the marketing, of seed potatoes within the Community.`;
2. the following Article shall be inserted after Article 1:
'Article 1a
For the purposes of this Directive "marketing" shall mean the sale, holding with a view to sale, offer for sale and any disposal, supply or transfer aimed at commercial exploitation of seed potatoes to third parties, whether or not for consideration.
Trade in seed potatoes not aimed at commercial exploitation of the variety, such as the following operations, shall not be regarded as marketing:
- the supply of seed potatoes to official testing and inspection bodies,
- the supply of seed potatoes to providers of services for processing or packaging,
provided the provider of services does not acquire title to seed potatoes thus supplied.
The supply of seed under certain conditions to providers of services for the production of certain agricultural raw materials, intended for industrial purposes, or seed propagation for that purpose, shall not be regarded as marketing, provided the provider of services does not acquire title to either the seed thus supplied or the product of the harvest. The supplier of seed shall provide the Certification Authority with a copy of the relevant parts of the contract made with the provider of services and this shall include the standards and conditions currently met by the seed provided.
The conditions for the application of this provision shall be determined in accordance with the procedure laid down in Article 19.`;
3. Article 3(2)(B) shall be repealed;
4. the following Article shall be inserted after Article 3:
'Article 3a
Notwithstanding Article 3(1), Member States shall provide that bred seed potatoes of generations prior to basic seed potatoes may be placed on the market.`;
5. the following Article shall be inserted after Article 4:
'Article 4a
1. Notwithstanding Article 3(1), Member States may authorise producers on their own territory to place on the market:
(a) small quantities of seed potatoes for scientific purposes or selection work;
(b) appropriate quantities of seed potatoes for other test or trial purposes, provided they belong to varieties for which an application for entry in the catalogue has been submitted in the Member State in question.
In the case of genetically modified material, such authorisation may be granted only if all appropriate measures have been taken to avoid adverse effects on human health and the environment. For the environmental risk assessment to be carried out in this respect, the provisions of Article 7(4) of Directive 70/457/EEC shall apply accordingly.
2. The purposes for which the authorities referred to in paragraph 1(b) may be given, the provisions relating to the marking of packages, and the quantities and the conditions under which Member States may grant such authorisation shall be determined in accordance with the procedure laid down in Article 19.
3. Authorisations granted before the date of adoption of this Directive by Member States to producers in their own territory for the purposes set out in paragraph 1 shall remain in force pending determination of the provisions referred to in paragraph 2. Thereafter, all such authorisations shall respect the provisions established in accordance with paragraph 2.`;
6. the following Article shall be inserted after Article 5:
'Article 5a
1. Member States may require that seed potatoes produced in their own territory may be separated during production from other potatoes for plant health reasons.
2. The requirements provided for in paragraph 1 may include measures to:
- separate the production of seed and other potatoes;
- separate the grading, storage, transportation and handling of seed and other potatoes.`;
7. Article 7(1) shall be replaced by the following:
'1. Member States shall provide that seed potatoes may not be placed on the market unless they have a minimum size such that they do not pass through a square mesh of 25 × 25 mm. In the case of tubers which are too large to pass through a square mesh of 35 × 35 mm, the upper and lower size limits shall be expressed in multiples of 5.
The maximum variation in size between tubers in a lot shall be such that the difference between the dimensions of the two square meshes used does not exceed 25 mm. These sizing standards may be modified in accordance with the procedure laid down in Article 19.`;
8. Article 7(4) shall be repealed;
9. in Article 9(3), the words 'sealed in their own territory. Conditions relating to these exceptions may be determined in accordance with the procedure laid down in Article 19` shall be added after the words 'small packages`;
10. Article 10(2) shall be replaced by the following:
'2. Member States may provide for exceptions to paragraph 1 in the case of small packages sealed in their own territory. Conditions relating to these exceptions may be determined in accordance with the procedure laid down in Article 19.`;
11. Article 11 shall be replaced by the following:
'Article 11
In accordance with the procedure laid down in Article 19, it may be provided that, in cases other than those provided for in this Directive, packages or containers of basic seed potatoes or certified seed potatoes shall bear a supplier's label (which may either be a label separate from the official label or take the form of the suppliers' information printed on the package or container itself). The particulars to be provided on any such label shall also be established in accordance with the procedure laid down in Article 19.`;
12. the following Article shall be inserted after Article 11:
'Article 11a
In the case of seed potatoes of a variety which has been genetically modified, any label or document, official or otherwise, which is affixed to or accompanies the seed lot, under the provisions of this Directive, shall clearly indicate that the variety has been genetically modified.`;
13. Article 13(1) shall be replaced by the following:
'1. Member States shall ensure that seed potatoes which are placed on the market under the provisions of this Directive, whether mandatory or discretionary, are not subject to any marketing restrictions as regards their characteristics, examination requirements, marking and sealing other than those laid down in this or any other Directive.`;
14. Article 13(4) shall be repealed;
15. the following Article shall be inserted after Article 13:
'Article 13a
The conditions under which bred seed potatoes of generations prior to basic seed potatoes may be placed on the market under Article 3a, shall be as follows:
(a) they must have been produced in accordance with accepted practices for the maintenance of the variety and of health;
(b) they must be intended mainly for the production of basic seed potatoes;
(c) they must satisfy the minimum conditions to be established by the procedure laid down in Article 19 for pre-basic seed potatoes;
(d) they must have been found by official examination to satisfy the minimum conditions referred to in (c);
(e) they must be placed in packages or containers in accordance with this Directive; and
(f) the packages or containers must bear an official label giving at least the following particulars:
- certification authority and Member State or their distinguishing abbreviation,
- producer's identification number or lot reference number,
- month and year of sealing,
- species, indicated at least in Roman characters, under its botanical name, which may be given in abridged form and without the authors' names, or under its common name, or both,
- variety, indicated at least in Roman characters,
- the description "pre-basic seed potatoes".
The label shall be white with a diagonal violet line.`;
16. Article 14(1) shall be replaced by the following:
'1. In accordance with the procedure laid down in Article 19, the Commission may prohibit, in whole or in part, the marketing of seed potatoes harvested in a particular area of the Community if the progeny of officially drawn samples of basic seed potatoes or certified seed potatoes harvested in that particular area and grown in one or more Community test fields has for three successive years fallen appreciably below the minimum conditions laid down in Annex I(1c), (2c), (3) and (4). Satisfaction of the other minimum conditions laid down in Annex I may also be checked during the comparative tests.`;
17. Article 14(2) shall be replaced by the following:
'2. Any measures taken under paragraph 1 shall be withdrawn by the Commission as soon as it has been established with adequate certainty that the basic seed potatoes and certified seed potatoes harvested in the particular area of the Community concerned will in future satisfy the minimum conditions referred to in paragraph 1.`;
18. Article 14(3) shall be repealed;
19. Article 16 shall be replaced by the following:
'Article 16
1. In order to remove any temporary difficulties in the general supply of basic seed potatoes or certified seed potatoes that occur in the Community and cannot be otherwise overcome, it may be decided in accordance with the procedure laid down in Article 19 that Member States shall permit, for a specified period, the marketing throughout the Community in quantities necessary to resolve the supply difficulties of seed potatoes of a category subject to less stringent requirements, or of seed potatoes of varieties not included in the Common Catalogue of Varieties of Agricultural Plant Species or in the national catalogues of varieties of the Member States.
2. For a category of seed potatoes of any given variety, the official label shall be that provided for the corresponding category; for seed potatoes of varieties not included in the abovementioned catalogues the colour of the official label shall be brown. The label shall always state that the seed potatoes in question are of a category satisfying less stringent requirements.
3. Rules for the application of paragraph 1 may be adopted in accordance with the procedure laid down in Article 19.`;
20. Article 18(1) shall be replaced by the following:
'1. Member States shall ensure that official inspections are carried out in relation to the marketing of seed potatoes, at least by random checks, to verify compliance with the requirements and conditions of this Directive.`;
21. Article 18(2) shall be replaced by the following:
'2. Without prejudice to the free movement of seed potatoes within the Community, Member States shall take all necessary measures to ensure that they are supplied with the following particulars during the marketing of quantities exceeding two kilograms of seed potatoes imported from third countries:
(a) species;
(b) variety;
(c) category;
(d) country of production and inspection authority;
(e) country of dispatch;
(f) importer;
(g) quantity of seed potatoes.
The manner in which these particulars are to be presented may be determined in accordance with the procedure laid down in Article 19.`;
22. the following Article shall be inserted after Article 20:
'Article 20a
1. Specific conditions may be established in accordance with the procedure laid down in Article 19 to take account of developments in the areas of:
(a) conditions under which chemically treated seed may be marketed;
(b) conditions under which seed may be marketed in relation to the conservation in situ and the sustainable use of plant genetic resources, including seed mixtures of species which also include species listed in Article 1 of Council Directive 70/457/EEC, and are associated with specific natural and semi-natural habitats and are threatened by genetic erosion;
(c) conditions under which seed suitable for organic production may be marketed.
2. The specific conditions referred to in paragraph 1 shall include in particular the following points:
(i) in the case of (b), the seed of these species shall be of a known provenance approved by the appropriate authority in each Member State for marketing the seed in defined areas;
(ii) in the case of (b), appropriate quantitative restrictions.`
Article 5
Directive 69/208/EEC is hereby amended as follows:
1. Article 1 shall be replaced by the following:
'Article 1
This Directive shall apply to the production with a view to marketing, and to the marketing within the Community, of seed of oil and fibre plants intended for agricultural production but not for ornamental purposes.`;
2. the following Article shall be inserted after Article 1:
'Article 1a
For the purposes of this Directive, "marketing" shall mean the sale, holding with a view to sale, offer for sale and any disposal, supply or transfer aimed at commercial exploitation of seed to third parties, whether or not for consideration.
Trade in seed not aimed at commercial exploitation of the variety, such as the following operations, shall not be regarded as marketing:
- the supply of seed to official testing and inspection bodies,
- the supply of seed to providers of services for processing or packaging, provided the provider of services does not acquire title to seed thus supplied.
The supply of seed under certain conditions to providers of services for the production of certain agricultural raw materials, intended for industrial purposes, or seed propagation for that purpose, shall not be regarded as marketing, provided the provider of services does not acquire title to either the seed thus supplied or the product of the harvest. The supplier of seed shall provide the Certification Authority with a copy of the relevant parts of the contract made with the provider of services and this shall include the standards and conditions currently met by the seed provided.
The conditions for the application of this provision shall be determined in accordance with the procedure laid down in Article 20.`;
3. Article 2(1c) shall be repealed;
4. in Article 3(1), the words 'and unless it satisfies the conditions laid down in Annex II` shall be deleted;
5. in Article 3(2), the words 'and unless the seed also satisfies the conditions laid down in Annex II` shall be deleted;
6. Article 3(5) shall be repealed;
7. the following Article shall be inserted after Article 3:
'Article 3a
Notwithstanding Article 3(1) and (2), Member States shall provide that:
- bred seed of generations prior to basic seed, and
- seed as grown, marketed for processing, provided that the identity of the seed is ensured,
may be placed on the market.`;
8. the following subparagraph shall be added at the end of Article 4:
'Member States making use of the derogation provided for in either subparagraph (a) or (b) shall assist each other administratively as regards inspection.`;
9. the following Article shall be inserted after Article 4:
'Article 4a
1. Notwithstanding Article 3(1) and (2), Member States may authorise producers in their own territory to place on the market:
(a) small quantities of seed for scientific purposes or selection work,
(b) appropriate quantities of seed for other test or trial purposes, provided it belongs to varieties for which an application for entry in the catalogue has been submitted in the Member State in question.
In the case of genetically modified material, such authorisation may be granted only if all appropriate measures have been taken to avoid adverse effects on human health and the environment. For the environmental risk assessment to be carried out in this respect, the provisions of Article 7(4) of Directive 70/457/EEC shall apply accordingly.
2. The purposes for which the authorisations referred to in paragraph 1(b) may be given, the provisions relating to the marking of packages, and the quantities and the conditions under which Member States may grant such authorisation, shall be determined in accordance with the procedure laid down in Article 20.
3. Authorisations granted before the date of adoption of this Directive by Member States to producers in their own territory for the purposes set out in paragraph 1 shall remain in force pending determination of the provisions referred to in paragraph 2. Thereafter, all such authorisations shall respect the provisions established in accordance with paragraph 2.`;
10. the following words shall be added at the end of Article 9(3): 'sealed in their own territory. Conditions relating to these exceptions may be determined in accordance with the procedure laid down in Article 20.`;
11. Article 10(2) shall be replaced by the following:
'2. Member States may provide for exceptions to paragraph 1 in the case of small packages sealed on their own territory. Conditions relating to these exceptions may be determined in accordance with the procedure laid down in Article 20.`;
12. Article 11 shall be replaced by the following:
'Article 11
In accordance with the procedure laid down in Article 20, it may be provided that Member States may require that, in cases other than those provided for in this Directive, packages of basic seed, certified seed of all categories or commercial seed shall bear a supplier's label (which may either be a label separate from the official label or take the form of suppliers' information printed on the package itself). The particulars to be provided on any such label shall also be established in accordance with the procedure laid down in Article 20.`;
13. the following Article shall be inserted after Article 11:
'Article 11a
In the case of seed of a variety which has been genetically modified, any label or document, official or otherwise, which is affixed to or accompanies the seed lot, under the provisions of this Directive, shall clearly indicate that the variety has been genetically modified.`;
14. Article 13(1) shall be replaced by the following:
'1. Member States shall ensure that seed which is placed on the market under the provisions of this Directive, whether mandatory or discretionary, is not subject to any marketing restrictions as regards its characteristics, examination requirements, marking and sealing other than those laid down in this or any other Directive.`;
15. Article 13(2) shall be repealed;
16. Article 13(3) shall be repealed;
17. the following Article shall be inserted after Article 14:
'Article 14a
The conditions under which bred seed of generations prior to basic seed may be placed on the market under the first indent of Article 3a, shall be as follows:
(a) it must have been officially inspected by the competent certification authority in accordance with the provisions applicable to the certification of basic seed;
(b) it must be packed in accordance with this Directive; and
(c) the packages must bear an official label giving at least the following particulars:
- certification authority and Member State or their distinguishing abbreviation,
- lot reference number,
- month and year of sealing, or
- month and year of the last official sampling for the purposes of certification,
- species, indicated at least under its botanical name, which may be given in abridged form and without the authors' names, in Roman characters,
- variety, indicated at least in Roman characters,
- the description "pre-basic seed",
- number of generations preceding seed of the categories "certified seed", or "certified seed of the first generation".
The label shall be white with a diagonal violet line.`;
18. Article 14(2) shall be replaced by the following:
'2. Seed of oil and fibre plants which has been harvested in the Community and which is intended for certification in accordance with paragraph 1 shall:
- be packed and labelled with an official label satisfying the conditions laid down in Annex V(A) and (B), in accordance with Article 9(1); and
- be accompanied by an official document satisfying the conditions laid down in Annex V(C).
The provisions in the first subparagraph on packing and labelling may be waived if the authorities responsible for field inspection, those drawing up the documents for the certification of seeds which have not been definitively certified and those responsible for certification are the same, or if they agree on exemption.`;
19. Article 16 shall be replaced by the following:
'Article 16
1. In order to remove any temporary difficulties in the general supply of basic or certified seed that occur in the Community and cannot be otherwise overcome, it may be decided in accordance with the procedure laid down in Article 20 that Member States shall permit, for a specified period, the marketing throughout the Community in quantities necessary to resolve the supply difficulties of seed of a category subject to less stringent requirements, or of seed of a variety not included in the Common Catalogue of Varieties of Agricultural Plant Species or in the national catalogues of varieties of the Member States.
2. For a category of seed of any given variety, the official label shall be that provided for the corresponding category; for seed of varieties not included in the abovementioned catalogues the official label shall be that provided for commercial seed. The label shall always state that the seed in question is of a category satisfying less stringent requirements.
3. Rules for the application of paragraph 1 may be adopted in accordance with the procedure laid down in Article 20.`;
20. Article 18(1) shall be replaced by the following:
'1. Member States shall ensure that official inspections are carried out in relation to the marketing of seed of oil and fibre plants, at least by random checks, to verify compliance with the requirements of this Directive.`;
21. Article 18(2) shall be replaced by the following:
'2. Without prejudice to the free movement of seed within the Community, Member States shall take all necessary measures to ensure that they are supplied with the following particulars during the marketing of quantities exceeding two kilograms of seed imported from third countries:
(a) species;
(b) variety;
(c) category;
(d) country of production and official inspection authority;
(e) country of dispatch;
(f) importer;
(g) quantity of seed.
The manner in which these particulars are to be presented may be determined in accordance with the procedure laid down in Article 20.`;
22. the following Article shall be inserted after Article 21:
'Article 21a
1. Specific conditions may be established in accordance with the procedure laid down in Article 20 to take account of developments in the areas of:
(a) conditions under which chemically treated seed may be marketed;
(b) conditions under which seed may be marketed in relation to the conservation in situ and the sustainable use of plant genetic resources, including seed mixtures of species which also include species listed in Article 1 of Council Directive 70/457/EEC, and are associated with specific natural and semi-natural habitats and are threatened by genetic erosion;
(c) conditions under which seed suitable for organic production may be marketed.
2. The specific conditions referred to in paragraph 1 shall include in particular the following points:
(i) in the case of (b), the seed of these species shall be of a known provenance approved by the appropriate Authority in each Member State for marketing the seed in defined areas;
(ii) in the case of (b), appropriate quantitative restrictions.`
Article 6
Directive 70/457/EEC is hereby amended as follows:
1. the following paragraphs shall be added after Article 4(3):
'4. In the case of a genetically modified variety within the meaning of Article 2(1) and (2) of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (*), the variety shall be accepted only if all appropriate measures have been taken to avoid adverse effects on human health and the environment.
5. However, where material derived from a plant variety is intended to be used as a food or food ingredient falling within the scope of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (**), these foods or food ingredients must not:
- present a danger for the consumer,
- mislead the consumer,
- differ from foods or food ingredients which they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer.
095.1
6. In the interest of conserving plant genetic resources as specified in Article 20(a)(3)(a) and (3)(b), the Member States may depart from the acceptance criteria set out in the first sentence of paragraph 1 in so far as specific conditions are established in accordance with the procedure laid down in Article 23 considering the requirements of Article 20(a)(4)(i), (4)(ii) and (4)(iii).
(*) OJ L 117, 8.5.1990, p. 15. Directive as last amended by Directive 97/35/EC (OJ L 169, 27.6.1997, p. 72).
(**) OJ L 43, 14.2.1997, p. 1.`;
2. the following subparagraph shall be added to Article 7(2):
'(c) the necessary arrangements for the growing trials to be carried out with a view to assessing the value for cultivation or use; these arrangements may determine:
- the procedures and conditions under which all or several Member States may agree to include in the growing trials, by way of administrative assistance, varieties for which a request for acceptance has been introduced in another Member State;
- the terms of cooperation between the authorities of the participating Member States;
- the impact of the results of the growing trials;
- the standards relating to information on growing trials for assessment of the value for cultivation or use.`;
3. the following paragraph shall be added after Article 7(3):
'4. (a) In the case of a genetically modified variety referred to in Article 4(4), an environmental risk assessment equivalent to that laid down in Directive 90/220/EEC shall be carried out.
(b) The procedures ensuring that the environmental risk assessment and other relevant elements shall be equivalent to those laid down in Directive 90/220/EEC shall be introduced on a proposal from the Commission, in a Council Regulation based on the appropriate legal basis in the Treaty. Until this Regulation enters into force genetically modified varieties shall only be accepted for inclusion in a national catalogue after having been accepted for marketing in accordance with Directive 90/220/EEC.
(c) Articles 11 to 18 of Directive 90/220/EEC shall no longer apply to genetically modified varieties once the Regulation referred to in subparagraph (b) above has entered into force.
(d) The technical and scientific details of the implementation of the environmental risk assessment shall be adopted in accordance with the procedure laid down in Article 23.`;
4. the following paragraph shall be added after Article 7(4):
'5. (a) The Member States shall ensure that a variety intended to be used for the purpose laid down in this paragraph is accepted only if:
- the food or the food ingredient has already been authorised pursuant to Regulation (EC) No 258/97, or
- the authorisation decisions referred to in Regulation (EC) No 258/97 are taken in accordance with the procedure provided for in Article 23 of this Directive.
(b) In the case laid down in the second indent of paragraph (a), the criteria set out in Article 4(5) and the assessment principles laid down in Regulation (EC) No 258/97 shall be taken into account.
(c) The technical and scientific details of the implementation of the measures laid down in paragraph (b) shall be adopted in accordance with the procedure laid down in Article 23 of this Directive.`;
5. the following paragraph shall be added after Article 9(4):
'5. Member States shall ensure that genetically modified varieties which have been accepted are clearly indicated as such in the catalogue of varieties. They shall further ensure that any person marketing such a variety clearly indicates in his sales catalogue that the variety is genetically modified.`;
6. the following paragraph shall be added after Article 12(a)(3):
'4. In accordance with the procedure laid down in Article 23 rules may be established for the application of paragraphs 1 and 2.`;
7. Article 12(2) shall be replaced by the following:
'2. Acceptance of a variety may be renewed at given intervals if it is still cultivated on such a scale as to justify this, or should be retained in the interest of conserving plant genetic resources, and providing that the requirements as to distinctness, uniformity and stability, or the criteria determined under Article 20(a)3 and 4, are still satisfied. Except in the case of plant genetic resources within the meaning of Article 20(a) applications for renewal shall be submitted not later than two years before expiry of acceptance.`;
8. Article 15(1) shall be replaced by the following:
'1. Member States shall ensure that, with effect from the publication referred to in Article 18, seed of varieties accepted in accordance with this Directive or in accordance with principles corresponding to those of this Directive is not subject to any marketing restrictions relating to variety.`;
9. Article 15(2) shall be replaced by the following:
'2. A Member State may, upon application which shall be dealt with as provided for in Article 23 or in Article 23a in the case of genetically modified varieties, be authorised to prohibit the use of the variety in all or in part of its territory or to lay down appropriate conditions for cultivating the variety in accordance, in cases provided for in subparagraph (c), with the conditions for using the products resulting from such cultivation:
(a) where it is established that the cultivation of the variety could be harmful from the point of view of plant health to the cultivation of other varieties or species, or
(b) where official growing trials carried out in the applicant Member States, Article 5(4) being applied correspondingly, show that the variety does not, in any part of its territory, produce results corresponding to those obtained from a comparable variety accepted in the territory of that Member State or, where it is well known that the variety is not suitable for cultivation in any part of its territory because of its type or maturity class. The application shall be lodged before the end of the third calendar year following that of acceptance;
(c) where it has valid reasons other than those already mentioned or which may have been mentioned during the procedure referred to in Article 10(2) for considering that the variety presents a risk for human health or the environment.`;
10. Article 15(3) shall be repealed;
11. Article 15(4) shall be repealed;
12. Article 15(5) shall be repealed;
13. Article 15(6) shall be repealed;
14. Article 15(7) shall be repealed;
15. the following subparagraph shall be added after the second subparagraph of Article 18:
'The published notice shall clearly indicate those varieties which have been genetically modified.`;
16. Article 19 shall be replaced by the following:
'Article 19
If it is established that the cultivation of a variety included in the common catalogue of varieties could in any Member State be harmful from the point of view of plant health to the cultivation of other varieties or species, or present a risk for the environment or for human health, that Member State may upon application, be authorised in accordance with the procedure laid down in Article 23 or in Article 23a in the case of a genetically modified variety to prohibit the marketing of the seed or propagating material of that variety in all or part of its territory. Where there is imminent danger of the spread of harmful organisms or imminent danger for human health or for the environment, that prohibition may be imposed by the Member State concerned as soon as its application has been lodged until such time as a final decision has been taken. That decision shall be taken within a period of three months in accordance with the procedure laid down in Article 23 or in Article 23a in the case of a genetically modified variety.`;
17. the following Article shall be added after Article 20:
'Article 20a
1. Specific conditions may be established in accordance with the procedure laid down in Article 23 to take account of developments in relation to the conditions under which chemically treated seed may be marketed.
2. Without prejudice to Council Regulation (EC) No 1467/94 of 20 June 1994 on the conservation, characterisation, collection and utilisation of genetic resources in agriculture (*), specific conditions shall be established in accordance with the procedure laid down in Article 23 to take account of developments in relation to the conservation in situ and the sustainable use of plant genetic resources through growing and marketing of seed of landraces and varieties which are naturally adapted to the local and regional conditions and threatened by genetic erosion.
3. The specific conditions referred to in paragraph 2 above shall include in particular the following points:
(i) landraces and varieties shall be accepted in accordance with the provisions of this Directive. The procedure for official acceptance shall take into account specific quality characteristics and requirements. In particular the results of unofficial tests and knowledge gained from practical experience during cultivation, reproduction and use and the detailed descriptions of the varieties and their relevant denominations, as notified to the Member State concerned, shall be taken into account and, if sufficient, shall result in exemption from the requirement of official examination. Upon acceptance of such a landrace or variety, it shall be indicated as a 'conservation variety` in the common catalogue;
(ii) appropriate quantitative restrictions.
(*) OJ L 159, 28.6.1994, p. 1.`;
18. the following Article shall be added after Article 23:
'Article 23a
1. Where the procedure laid down in this Article is to be followed, matters shall be referred by the Chairman, either on his own initiative or at the request of the representative of a Member State, to the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry (hereinafter called the "Committee").
2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.
The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
If the measures envisaged are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If on the expiry of a period of three months from referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.`;
19. the following Article shall be added after Article 24:
'Article 24a
Specific conditions may be established in accordance with the procedure laid down in Article 23 to take account of developments in the area of the conservation of genetic resources.`
Article 7
Directive 70/458/EEC is hereby amended as follows:
1. Article 1 shall be replaced by the following:
'Article 1
This Directive shall apply to the production with a view to marketing, and to the marketing, of vegetable seed within the Community.`;
2. the following Article shall be added after Article 1:
'Article 1a
For the purposes of this Directive, "marketing" shall mean the sale, holding with a view to sale, offer for sale and any disposal, supply or transfer aimed at commercial exploitation of seed to third parties, whether or not for consideration.
Trade in seed not aimed at commercial exploitation of the variety, such as the following operations, shall not be regarded as marketing:
- the supply of seed to official testing and inspection bodies,
- the supply of seed to providers of services for processing or packaging, provided the provider of services does not acquire title to seed thus supplied.
The supply of seed under certain conditions to providers of services for the production of certain agricultural raw materials, intended for industrial purposes, or seed propagation for that purpose, shall not be regarded as marketing, provided the provider of services does not acquire title to either the seed thus supplied or the product of the harvest. The supplier of seed shall provide the Certification Authority with a copy of the relevant parts of the contract made with the provider of services and this shall include the standards and conditions currently met by the seed provided.
The conditions for the application of this provision shall be determined in accordance with the procedure laid down in Article 40.`;
3. Article 2(1b) shall be repealed;
4. Article 4 shall be replaced by the following:
'Article 4
1. The Member States shall ensure that a variety is accepted only if it is distinct, stable and sufficiently uniform.
In the case of industrial chicory, the variety must be of satisfactory value for cultivation and use.
2. In the case of a genetically modified variety within the meaning of Article 2(1) and (2) of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (*), the variety shall be accepted only if all appropriate measures have been taken to avoid adverse effects on human health and the environment.
3. However, where material derived from a plant variety is intended to be used as a food or food ingredient falling within the scope of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (**), these foods or food ingredients must not:
- present a danger for the consumer,
- mislead the consumer,
- differ from foods or food ingredients which they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer.
4. In the interest of conserving plant genetic resources as specified in Article 39(a)(2)(a) and (2)(b), the Member States may depart from the acceptance criteria set out in paragraph 1 in so far as specific conditions are established in accordance with the procedure laid down in Article 40 considering the requirements of Article 39(a)(3)(i) and 3(ii).
(*) OJ L 117, 8.5.1990, p. 15. Directive as last amended by Directive 97/35/EC (OJ L 169, 27.6.1997, p. 72).
(**) OJ L 43, 14.2.1997, p. 1.`;
5. in Article 7(1), first subparagraph, the following shall be added to the last sentence: 'in relation to the results of an official examination.`;
6. the following paragraph shall be added after Article 7(3):
'4. (a) In the case of a genetically modified variety as referred to in Article 4(4) an environmental risk assessment equivalent to that laid down in Directive 90/220/EEC shall be carried out.
(b) The procedures ensuring that the environmental risk assessment and other relevant elements shall be equivalent to those laid down in Directive 90/220/EEC shall be introduced on an proposal from the Commission, in a Council Regulation based on the appropriate legal basis in the Treaty. Until this Regulation enters into force genetically modified varieties shall only be accepted for inclusion in a national catalogue after having being accepted for marketing in accordance with Directive 90/220/EEC.
(c) Articles 11 to 18 of Directive 90/220/EEC shall no longer apply to genetically modified varieties once the Regulation referred to in subparagraph (b) above has entered into force.
(d) The technical and scientific details of the implementation of the environmental risk assessment shall be adopted in accordance with the procedure laid down in Article 40.`;
7. the following paragraphs shall be added after Article 7(4):
'5. (a) The Member States shall ensure that a variety intended to be used for the purpose laid down this paragraph is accepted only if:
- the food or the food ingredient have already been authorised pursuant to Regulation (EC) No 258/97, or
- the authorisation decisions referred to in Regulation (EC) No 258/97 are taken in accordance with the procedure provided for in Article 40 of this Directive.
(b) In the case laid down in the second indent of paragraph (a), the criteria set out in Article 4(5) and the assessment principles laid down in Regulation (EC) No 258/97 shall be taken into account.
(c) The technical and scientific details of the implementation of the measures laid down in paragraph (b) shall be adopted in accordance with the procedure laid down in Article 40 of this Directive.`;
8. the following paragraph shall be added after Article 10(4):
'5. Member States shall ensure that genetically modified varieties which have been accepted are clearly indicated as such in the catalogue of varieties. They shall further ensure that any person marketing such a variety clearly indicates in his sales catalogue that the variety is genetically modified.`;
9. Article 13(2) shall be replaced by the following:
'2. Acceptance of a variety may be renewed a given intervals if it is still cultivated on such a scale as to justify this, or should be retained in the interest of conserving plant genetic resources, and providing that the requirements as to distinctness, uniformity and stability, or the criteria determined under Article 39(a)(3) and (4), are still satisfied. Except in the case of plant genetic resources within the meaning of Article 39(a), applications for renewal shall be submitted not later than two years before expiry of acceptance.`;
10. the following paragraph shall be added after Article 15(2):
'3. In the case of varieties the acceptance of which has been renewed pursuant to Article 13(3), Member States may allow the names used before such renewal to be used until 30 June 1994.`;
11. the following paragraph shall be added after Article 13(a)(3):
'4. In accordance with the procedure laid down in Article 40 rules may be established for the application of paragraphs 1, 2 and 3.`;
12. in the second and third subparagraphs of Article 16(1), the words 'after expiry of a period of two months following` shall be replaced by the words 'with effect from`;
13. in Article 17, the words 'after expiry of a period of two months` shall be deleted;
14. Article 16(2) shall be replaced by the following:
'2. A Member State may, upon application which shall be dealt with as provided for in Article 40 or in Article 40(a) in the case of genetically modified varieties, be authorised to prohibit the use of the variety in all or in part of its territory or to lay down appropriate conditions for cultivating the variety in accordance, in cases provided for in paragraph (b), with the conditions for using the products resulting from such cultivation:
(a) where it is established that the cultivation of the variety could be harmful from the point of view of plant health to the cultivation of other varieties or species; or
(b) where it has valid reasons other than those already mentioned or which may have been mentioned during the procedure referred to in Article 11(2) for considering that the variety presents a risk for human health or the environment.`;
15. Article 16(3) shall be repealed;
16. Article 16(4) shall be repealed;
17. the following paragraph shall be added after the second paragraph of Article 17:
'The published notice shall clearly indicate those varieties which have been genetically modified.`;
18. Article 18 shall be replaced by the following:
'Article 18
If it is established that the cultivation of a variety included in the common catalogue of varieties could in any Member State be harmful from the point of view of plant health to the cultivation of other varieties or species, or present a risk for the environment or for human health, that Member State may upon application, be authorised in accordance with the procedure laid down in Article 40 or in Article 40(a) in the case of a genetically modified variety to prohibit the marketing of the seed or propagating material of that variety in all or part of its territory. Where there is imminent danger of the spread of harmful organisms or imminent danger for human health or for the environment, that prohibition may be imposed by the Member State concerned as soon as its application has been lodged until such time as a final decision has been taken. That decision shall be taken within a period of three months in accordance with the procedure laid down in Article 40 or in Article 40(a) in the case of genetically modified variety.`;
19. in Article 20(1), the words 'and unless it satisfies the conditions laid down in Annex II` shall be deleted;
20. in Article 20(1)(a), the words 'and unless it satisfies the conditions laid down in Annex II` shall be deleted;
21. Article 20(4) shall be repealed;
22. the following Article shall be inserted after Article 20:
'Article 20a
Notwithstanding Article 20(1) and (1a), Member States shall provide that:
- bred seed of generations prior to basic seed, and
- seed as grown, marketed for processing, provided that the identity of the seed is ensured,
may be placed on the market.`;
23. the following subparagraph shall be added at the end of Article 21:
'Member States making use of the derogation provided for in either subparagraph (a) or (b) shall assist each other administratively as regards inspection.`;
24. the following Article shall be inserted after Article 21:
'Article 21a
1. Notwithstanding Article 20(1) and (1a), Member States may:
(a) authorise producers on their own territory to place on the market small quantities of seed for scientific or selection purposes;
(b) authorise breeders and their representatives established in their territory to market, for a limited period, seed belonging to a variety for which an application for inclusion in a national catalogue has been submitted in at least one Member State and for which specific technical information has been submitted.
2. The conditions under which Member States may grant the authorisations referred to in paragraph (b) above shall be determined in accordance with the procedure laid down in Article 40, particularly as regards the acquisition of data, the type of data, the storage and name of the variety and the labelling of packages.
3. Authorisations granted before the date of adoption of the present directive by Member States to producers in their own territory for the purposes set out in paragraph 1 shall remain in force pending determination of the provisions referred to in paragraph 2. Thereafter, all such authorisations shall respect the provisions established in accordance with paragraph 2.`;
25. Article 24(3) shall be replaced by the following:
'3. Notwithstanding paragraph 1, Member States may authorise their own producers to place on the market small packages of mixtures of standard seed of different varieties of the same species. The species, where this provision applies, the rules for the maximum size of the small packages and the requirements for labelling shall be established in accordance with the procedure laid down in Article 40.`;
26. the following words shall be added at the end of Article 25(4):
'. . . closed on their own territory. Conditions relating to these exceptions may be determined in accordance with the procedure laid down in Article 40.`;
27. Article 26(1a) shall be replaced by the following:
'1a. Member States may provide for exceptions to paragraph 1 in the case of small packages sealed in their own territory. Conditions relating to these exceptions may be determined in accordance with the procedure laid down in Article 40.`;
28. Article 28(1) shall be replaced by the following:
'1. In accordance with the procedure laid down in Article 40, it may be provided that in cases other than those already provided for in this Directive, packages of basic seed, certified seed of any kind or standard seed shall bear a supplier's label (which may either be a label separate from the official label or take the form of supplier's information printed on the package itself).
The particulars to be provided on any such label shall also be established in accordance with the procedure laid down in Article 40.`;
29. the following Article shall be inserted after Article 28:
'Article 28a
In the case of seed of a variety which has been genetically modified, any label or document, official or otherwise, which is affixed to or accompanies the seed lot, under the provisions of this Directive, shall clearly indicate that the variety has been genetically modified.`;
30. Article 30(1) shall be replaced by the following:
'1. Member States shall ensure that seed which is placed on the market under the provisions of this Directive, whether mandatory or discretionary, is not subject to any marketing restrictions as regards its characteristics, examination requirements, marking and sealing other than those laid down in this or any other Community Directive.`;
31. Article 30(3) shall be repealed;
32. the following Article shall be inserted after Article 30:
'Article 30a
The conditions under which bred seed of generations prior to basic seed may be placed on the market under the first indent of Article 20a, shall be as follows:
(a) it must have been officially inspected by the competent certification authority in accordance with the provisions applicable to the certification of basic seed;
(b) it must be packed in accordance with this Directive; and
(c) the packages must bear an official label giving at least the following particulars:
- certification authority and Member State or their distinguishing abbreviation,
- lot reference number,
- month and year of sealing, or
- month and year of the last official sampling for the purposes of certification,
- species, indicated at least under its botanical name, which may be given in abridged form and without the authors' names, in Roman characters,
- variety, indicated at least in Roman characters,
- the description 'pre-basic seed`,
- number of generations preceding seed of the category 'certified seed`.
The label shall be white with a diagonal violet line.`;
33. Article 31(2) shall be replaced by the following:
'2. Vegetable seed which has been harvested in the Community and which is intended for certification in accordance with paragraph 1 shall:
- be packed and labelled with an official label satisfying the conditions laid down in Annex V(A) and (B), in accordance with Article 25(1), and
- be accompanied by an official document satisfying the conditions laid down in Annex V(C).
The provisions in the first indent on packaging and labelling may be waived if the authorities responsible for field inspections, those drawing up the documents for the certification of seeds which have not been definitively certified and those responsible for certification are the same, or if they agree on exemption.`;
34. Article 33 shall be replaced by the following:
'Article 33
1. In order to remove any temporary difficulties in the general supply of basic certified or standard seed that occur in the Community and cannot be otherwise overcome, it may be decided in accordance with the procedure laid down in Article 40 that Member States shall permit, for a specified period, the marketing throughout the Community in quantities necessary to resolve the supply difficulties of seed of a category subject to less stringent requirements, or of seed of a variety not included in the Common Catalogue of Varieties of Vegetable Species or in the national catalogues of varieties of the Member States.
2. For a category of seed of any given variety, the official label or suppliers' label shall be that provided for the corresponding category; for seed of varieties not included in the abovementioned catalogues the colour of the label shall be brown. The label shall always state that the seed in question is of a category satisfying less stringent requirements.
3. Rules for the application of paragraph 1 may be adopted in accordance with the procedure laid down in Article 40.`;
35. Article 35(1) shall be replaced by the following:
'1. Member States shall ensure that official inspections are carried out in relation to the marketing of vegetable seed, at least by random checks, to verify compliance with the requirements and conditions of this Directive.`;
36. Article 35(2) shall be replaced by the following:
'2. Without prejudice to the free movement of seed within the Community, Member States shall take all necessary measures to ensure that they are supplied with the following particulars during the marketing of quantities exceeding two kilograms of seed imported from third countries:
(a) species;
(b) variety;
(c) category;
(d) country of production and official inspection authority;
(e) country of dispatch;
(f) importer;
(g) quantity of seed.
The manner in which these particulars are to be presented may be determined in accordance with the procedure laid down in Article 40.`;
37. the following Article shall be added after Article 39:
'Article 39a
1. Specific conditions may be established in accordance with the procedure laid down in Article 40 to take account of developments in relation to the conditions under which chemically treated seed may be marketed.
2. Specific conditions shall be established in accordance with the procedure laid down in Article 40 to take account of developments in relation to the conservation in situ and the sustainable use of plant genetic resources through growing and marketing of seed of:
(a) landraces and varieties which have been traditionally grown in particular localities and regions and threatened by genetic erosion without prejudice to the provisions of Regulation (EC) No 1467/94;
(b) varieties with no intrinsic value for commercial crop production but developed for growing under particular conditions.
3. The specific conditions referred to in paragraph 2 shall include in particular the following points:
(i) in the case of (a), the landraces and varieties shall be accepted in accordance with the provisions of this Directive. In particular the results of unofficial tests and knowledge gained from practical experience during cultivation, reproduction and use and the detailed descriptions of the varieties and their relevant denominations, as notified to the Member State concerned, shall be taken into account and, if sufficient, shall result in exemption from the requirement of official examination. Upon acceptance of such a landrace or variety, it shall be indicated as a 'conservation variety` in the common catalogue;
(ii) in the case of (a) and (b) appropriate quantitative restrictions.`;
38. the following Article shall be added after Article 40:
'Article 40a
1. Where the procedure laid down in this Article is to be followed, matters shall be referred by the Chairman, either on his own initiative or at the request of the representative of a Member State, to the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry (hereinafter called the 'Committee`).
2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.
The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
If the measures envisaged are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If on the expiry of a period of three months from referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.`;
39. the following Article shall be inserted after Article 41:
'Article 41a
1. Specific conditions may be established in accordance with the procedure laid down in Article 40 to take account of developments in the areas of:
(a) conditions under which chemically treated seed may be marketed;
(b) conditions under which seed may be marketed in relation to the conservation in situ and the sustainable use of plant genetic resources, including seed mixtures of species which also include species listed in Article 1 of Council Directive 70/457/EEC, and are associated with specific natural and semi-natural habitats and are threatened by genetic erosion;
(c) conditions under which seed suitable for organic production may be marketed.
2. The specific conditions referred to in paragraph 1 shall include in particular the following points:
(i) in the case of (b), the seed of these species shall be of a known provenance approved by the appropriate Authority in each Member State for marketing the seed in defined areas;
(ii) in the case of (b), appropriate quantitative restrictions.`;
40. Article 42 shall be replaced by the following:
'Article 42
Upon application by a Member State, which will be dealt with as provided for in Article 40, that State may be wholly or partially released from the obligation to apply this Directive, to certain species which are not normally reproduced or marketed in its territory, save where this would run counter to Articles 16(1) and 30(1).`
Article 8
1. Member States may, during a transitional period of not more than four years after the entry into force of the laws, regulations or administrative provisions necessary for them to comply with this Directive and by way of derogation from Article 2(1)(C)(a) and (b) of Directive 66/401/EEC, permit the marketing of seed of a generation previously permitted.
2. Member States may also, during a transitional period of not more than four years after the entry into force of the laws, regulations or administrative provisions necessary for them to comply with this Directive and by way of derogation from Article 3(22) of this Directive, which repeals Article 14(2)(a) of Directive 66/402/EEC, continue to restrict the marketing of certified seed of oats, barley, rice, triticale, wheat or spelt to that of the first generation.
3. Member States which currently operate restrictions on the marketing of fodder plant seeds in mixtures in accordance with Article 13 of Directive 66/401/EEC may also, during a transitional period of not more than four years after the entry into force of the laws, regulations and administrative provisions necessary for them to comply with this Directive and by way of derogation from Article 2(19) of this Directive, continue to prohibit the marketing of mixtures of fodder plant seeds.
Article 9
1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than twelve months after the date of notification of this Directive.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication.
The methods of making such reference shall be laid down by Member States.
2. Member States shall immediately communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof.
Article 10
This Directive is addressed to the Member States.
|
[
"UKSI20001788",
"UKSI20001791",
"UKSI20001792",
"UKSI20001789",
"UKSI20001793",
"UKSI20001790"
] |
31998L0096
|
1998
|
Council Directive 98/96/EC of 14 December 1998 amending, inter alia, as regards unofficial field inspections under Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 66/403/EEC, 69/208/EEC, 70/457/EEC and 70/458/EEC on the marketing of beet seed, fodder plant seed, cereal seed, seed potatoes, seed of oil and fibre plants and vegetable seed and on the common catalogue of varieties of agricultural plant species
Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas, for the reasons given below, the following Directives on the marketing of seed and propagating material should be amended:
- Council Directive 66/400/EEC of 14 June 1966 on the marketing of beet seed (4),
- Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (5),
- Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (6),
- Council Directive 66/403/EEC of 14 June 1966 on the marketing of seed potatoes (7),
- Council Directive 69/208/EEC of 30 June 1969 on the marketing of seed of oil and fibre plants (8),
- Council Directive 70/457/EEC of 29 September 1970 on the common catalogue of varieties of agricultural plant species (9), and
- Council Directive 70/458/EEC of 29 September 1970 on the marketing of vegetable seed (10);
Whereas Commission Decision 89/540/EEC of 22 September 1989 on the organisation of a temporary experiment on the marketing of seeds and propagating material (11), organised a temporary experiment under specified conditions, with the aim of assessing whether unofficial field inspections could ensure simplification of the procedures for official seed certification required under Directives 66/400/EEC, 66/401/EEC, 66/402/EEC and 69/208/EEC without a significant decrease in the quality of the seed;
Whereas the results of the experiment have shown that, for certain purposes, there could be a simplification of the procedures for official seed certification of 'certified seed` of all categories, if inspections were allowed to be carried out by inspectors other than those charged with official examination by the seed certification authority;
Whereas administrative developments have taken place in the Member States;
Whereas Directives 66/400/EEC, 66/401/EEC, 66/402/EEC and 69/208/EEC should be amended accordingly;
Whereas Directives 66/401/EEC, 66/402/EEC, 69/208/EEC and 70/458/EEC provide for amendments to be made to the lists of species referred to therein in the light of the development of scientific or technical knowledge concerning the names and hybrids resulting from the crossing of species covered by those Directives, in accordance with the Standing Committee procedure;
Whereas it is desirable to facilitate the addition of new species to the list of species in the said directives;
Whereas those directives should be amended accordingly;
Whereas Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 69/208/EEC and 70/458/EEC provide for the organisation of temporary experiments for the purpose of seeking improved alternatives to certain elements of the certification schemes adopted thereunder;
Whereas, in the light of experience, it is desirable to extend the scope of the organization of such experiments for the purpose of seeking improved alternatives to certain provisions set out in the said directives;
Whereas it is desirable to provide a legal base in Directive 66/403/EEC for the organization of temporary experiments for the purpose of seeking improved alternatives to certain provisions set out in that directive;
Whereas it is desirable to provide in Directives 70/457/EEC and 70/458/EEC for rules in relation to the suitability of varietal denominations,
Article 1
Directive 66/400/EEC is hereby amended as follows:
1. Article 2(1)(C)(d) shall be replaced by the following:
'(d) (i) which has been found by official examination to satisfy the above mentioned conditions, or
(ii) in the case of the conditions laid down in Annex I(A), has been found to satisfy those conditions either by official examination or by examination carried out under official supervision.`;
2. in Article 2 the following paragraphs shall be added:
'3. When the examination under official supervision referred to in paragraph 1(C)(d)(ii) above is carried out, the following requirements shall be complied with:
(i) the inspectors, shall:
(a) have the necessary technical qualifications;
(b) derive no private gain in connection with the carrying out of the inspections;
(c) have been officially licensed by the seed certification authority of the Member State concerned and this licensing shall include either the swearing-in of inspectors or the signature by inspectors of a written statement of commitment to the rules governing official examinations;
(d) carry out inspections under official supervision in accordance with the rules applicable to official inspections;
(ii) the seed crop to be inspected shall be grown from seed which has undergone official post-control, the results of which have been satisfactory;
(iii) a proportion of the seed crops shall be checked by official inspectors. That proportion shall be 10 % for self-pollinated crops and 20 % for cross-pollinated crops or, for those species for which Member States provide for official laboratory seed-testing using morphological, physiological or, where appropriate, biochemical procedures to identify the variety and establish purity, 5 % and 15 % respectively;
(iv) a proportion of samples from the seed lots harvested from the seed crops shall be drawn for official post-control and, where appropriate, for official laboratory seed testing in respect of varietal identity and purity;
(v) the Member States shall determine the penalties applicable to infringements of the rules governing examination under official supervision. The penalties they provide for must be effective, proportionate and dissuasive. Penalties may include the withdrawal of the recognition referred to in paragraph (3)(i)(c) from officially licensed inspectors who are found guilty of deliberately or negligently contravening the rules governing official examinations. Any certification of the seed examined shall be annulled in the event of such contravention unless it can be shown that such seed still meets all relevant requirements.
4. Further measures applicable to the carrying out of examinations under official supervision may be adopted in accordance with the procedure laid down in Article 21.
Until such measures are adopted, the conditions set out in Article 2 of Commission Decision 89/540/EEC shall be adhered to.`;
3. the first paragraph of Article 13a shall be replaced by the following:
'For the purpose of seeking improved alternatives to certain provisions set out in this Directive, it may be decided to organise temporary experiments under specified conditions at Community level in accordance with the provisions laid down in Article 21.`;
4. point 3 of Annex I(A) shall be replaced by the following:
'3. In the case of certified seed of all categories there shall be at least one field inspection, either official or under official supervision, and in the case of basic seed at least two official field inspections, one of stecklings and one of the seed-producing plants.`
Article 2
Directive 66/401/EEC is hereby amended as follows:
1. Article 2(1)(C)(d) shall be replaced by the following:
'(d) (i) which has been found by official examination to satisfy the abovementioned conditions, or
(ii) in the case of the conditions laid down in Annex I, has been found to satisfy those conditions either by official examination or by examination carried out under official supervision`;
2. Article 2(1a) shall be replaced by the following:
'1a. Amendments to be made to the list of species referred to in paragraph 1(A) shall be adopted in accordance with the procedure laid down in Article 21.`;
3. in Article 2 the following paragraphs shall be added:
'3. When the examination under official supervision referred to in paragraph 1(C)(d)(ii) above is carried out, the following requirements shall be complied with:
(i) the inspectors shall:
(a) have the necessary technical qualifications;
(b) derive no private gain in connection with the carrying out of the inspections;
(c) have been officially licensed by the seed certification authority of the Member State concerned and this licensing shall include either the swearing-in of inspectors or the signature by inspectors of a written statement of commitment to the rules governing official examinations;
(d) carry out inspections under official supervision in accordance with the rules applicable to official inspections;
(ii) the seed crop to be inspected shall be grown from seed which has undergone official post-control, the results of which have been satisfactory;
(iii) a proportion of the seed shall be checked by official inspectors. That proportion shall be 10 % for self-pollinated crops and 20 % for cross-pollinated crops or, for those species for which Member States provide for official laboratory seed-testing using morphological, physiological or, where appropriate, biochemical procedures to identify the variety and establish purity, 5 % and 15 % respectively;
(iv) a proportion of samples from the seed lots harvested from the seed crops shall be drawn for official post-control and, where appropriate, for official laboratory seed testing in respect of varietal identity and purity;
(v) the Member States shall determine the penalties applicable to infringements of the rules governing examination under official supervision. The penalties they provide for must be effective, proportionate and dissuasive. Penalties may include the withdrawal of the recognition referred to in paragraph (3)(i)(c) from officially licensed inspectors who are found guilty of deliberately or negligently contravening the rules governing official examinations. Any certification of the seed examined shall be annulled in the event of such contravention unless it can be shown that such seed still meets all relevant requirements.
4. Further measures applicable to the carrying out of examinations under official supervision may be adopted in accordance with the procedure laid down in Article 21.
Until such measures are adopted, the conditions set out in Article 2 of Commission Decision 89/540/EEC shall be adhered to.`;
4. the first paragraph of Article 13a shall be replaced by the following:
'For the purpose of seeking improved alternatives to certain provisions set out in this directive, it may be decided to organise temporary experiments under specified conditions at Community level in accordance with the provisions laid down in Article 21.`;
5. the first sentence of point 6 of Annex I shall be replaced by the following:
'6. The satisfaction of the abovementioned standards or other conditions shall, in the case of basic seed, be examined in official field inspections and, in the case of certified seed, be examined either in official field inspections or in inspections carried out under official supervision.`
Article 3
Directive 66/402/EEC is hereby amended as follows:
1. Article 2(1)(E)(d) shall be replaced by the following:
'(d) (i) which has been found by official examination to satisfy the abovementioned conditions, or
(ii) in the case of the conditions laid down in Annex I, has been found to satisfy those conditions either by official examination or by examination carried out under official supervision.`;
2. Article 2(1)(F)(d) shall be replaced by the following:
'(d) (i) which has been found by official examination to satisfy the abovementioned conditions, or
(ii) in the case of the conditions laid down in Annex I, has been found to satisfy those conditions either by official examination or by examination carried out under official supervision.`;
3. Article 2(1)(G)(d) shall be replaced by the following:
'(d) (i) which has been found by official examination to satisfy the abovementioned conditions, or
(ii) in the case of the conditions laid down in Annex I, has been found to satisfy those conditions either by official examination or by examination carried out under official supervision.`;
4. Article 2(1a) shall be replaced by the following:
'1a. Amendments to be made to the list of species referred to in paragraph 1(A) shall be adopted in accordance with the procedure laid down in Article 21.`;
5. in Article 2 the following paragraphs shall be added:
'3. When the examination under official supervision referred to in paragraphs 1(E)(d)(ii), 1(F)(d)(ii) and 1(G)(d)(ii) above is carried out, the following requirements shall be complied with:
(i) the inspectors shall:
(a) have the necessary technical qualifications;
(b) derive no private gain in connection with the carrying out of the inspections;
(c) have been officially licensed by the seed certification authority of the Member State concerned and this licensing shall include either the swearing-in of inspectors or the signature by inspectors of a written statement of commitment to the rules governing official examinations;
(d) carry out inspections under official supervision in accordance with the rules applicable to official inspections;
(ii) the seed crop to be inspected shall be grown from seed which has undergone official post-control, the results of which have been satisfactory;
(iii) a proportion of the seed shall be checked by official inspectors. That proportion shall be 10 % for self-pollinated crops and 20 % for cross-pollinated crops or, for those species for which Member States provide for official laboratory seed-testing using morphological, physiological or, where appropriate, biochemical procedures to identify the variety and establish purity, 5 % and 15 % respectively;
(iv) a proportion of samples from the seed lots harvested from the seed crops shall be drawn for official post-control and, where appropriate, for official laboratory seed testing in respect of varietal identity and purity;
(v) the Member States shall determine the penalties applicable to infringements of the rules governing examination under official supervision. The penalties they provide for must be effective, proportionate and dissuasive. Penalties may include the withdrawal of the recognition referred to in paragraph (3)(i)(c) from officially licensed inspectors who are found guilty of deliberately or negligently contravening the rules governing official examinations. Any certification of the seed examined shall be annulled in the event of such contravention unless it can be shown that such seed still meets all relevant requirements.
4. Further measures applicable to the carrying out of examinations under official supervision may be adopted in accordance with the procedure laid down in Article 21.
Until such measures are adopted, the conditions set out in Article 2 of Commission Decision 89/540/EEC shall be adhered to.`;
6. in Article 13a the first paragraph shall be replaced by the following:
'For the purpose of seeking improved alternatives to certain provisions set out in this directive, it may be decided to organise temporary experiments under specified conditions at Community level in accordance with the provisions laid down in Article 21.`;
7. the first sentence of point 5 of Annex I shall be replaced by the following:
'5. The satisfaction of the abovementioned standards or other conditions shall, in the case of basic seed, be examined in official field inspections and, in the case of certified seed, be examined either in official field inspections or in inspections carried out under official supervision.`
Article 4
Directive 66/403/EEC is hereby amended as follows:
The following Article shall be added after Article 13:
'Article 13a
For the purpose of seeking improved alternatives to certain provisions set out in this Directive, other than those relating to plant health, it may be decided to organise temporary experiments under specified conditions at Community level in accordance with the provisions laid down in Article 19.
In the framework of such experiments, Member States may be released from certain obligations laid down in this Directive. The extent of that release shall be defined with reference to the provisions to which it applies. The duration of an experiment shall not exceed seven years.`
Article 5
Directive 69/208/EEC is hereby amended as follows:
1. Article 2(1)(C)(d) shall be replaced by the following:
'(d) (i) which has been found by official examination to satisfy the abovementioned conditions, or
(ii) in the case of the conditions laid down in Annex I, has been found to satisfy those conditions either by official examination or by examination carried out under official supervision.`;
2. Article 2(1)(D)(d) shall be replaced by the following:
'(d) (i) which has been found by official examination to satisfy the abovementioned conditions, or
(iii) in the case of the conditions laid down in Annex I, has been found to satisfy those conditions either by official examination or by examination carried out under official supervision.`;
3. Article 2(1)(E)(d) shall be replaced by the following:
'(d) (i) which has been found by official examination to satisfy the abovementioned conditions, or
(ii) in the case of the conditions laid down in Annex I, has been found to satisfy those conditions either by official examination or by examination carried out under official supervision.`;
4. Article 2(1)(Ea)(d) shall be replaced by the following:
'(d) (i) which has been found by official examination to satisfy the abovementioned conditions, or
(ii) in the case of the conditions laid down in Annex I, has been found to satisfy those conditions either by official examination or by examination carried out under official supervision.`;
5. Article 2(1)(F)(d) shall be replaced by the following:
'(d) (i) which has been found by official examination to satisfy the abovementioned conditions, or
(ii) in the case of the conditions laid down in Annex I, has been found to satisfy those conditions either by official examination or by examination carried out under official supervision.`;
6. Article 2(1a) shall be replaced by the following:
'1a. Amendments to be made to the list of species referred to in paragraph 1(A) shall be adopted in accordance with the procedure laid down in Article 20.`;
7. In Article 2 the following paragraphs shall be added:
'3. When the examination under official supervision referred to in paragraphs 1(C)(d)(ii), 1(D)(d)(ii), 1(E)(d)(ii), 1(Ea)(d)(ii) and 1(F)(d)(ii) above is carried out, the following requirements shall be complied with:
(i) the inspectors shall:
(a) have the necessary technical qualifications;
(b) derive no private gain in connection with the carrying out of the inspections;
(c) have been officially licensed by the seed certification authority of the Member State concerned and this licensing shall include either the swearing-in of inspectors or the signature by inspectors of a written statement of commitment to the rules governing official examinations;
(d) carry out inspections under official supervision in accordance with the rules applicable to official inspections;
(ii) the seed crop to be inspected shall be grown from seed which has undergone official post-control, the results of which have been satisfactory;
(iii) a proportion of the seed shall be checked by official inspectors. That proportion shall be 10 % for self-pollinated crops and 20 % for cross-pollinated crops or, for those species for which Member States provide for official laboratory seed-testing using morphological, physiological or, where appropriate, biochemical procedures to identify the variety and establish purity, 5 % and 15 % respectively;
(iv) a proportion of samples from the seed lots harvested from the seed crops shall be drawn for official post-control and, where appropriate, for official laboratory seed testing in respect of varietal identity and purity;
(v) the Member States shall determine the penalties applicable to infringements of the rules governing examination under official supervision. The penalties they provide for must be effective, proportionate and dissuasive. Penalties may include the withdrawal of the recognition referred to in paragraph (3)(i)(c) from officially licensed inspectors who are found guilty of deliberately or negligently contravening the rules governing official examinations. Any certification of the seed examined shall be annulled in the event of such contravention unless it can be shown that such seed still meets all relevant requirements.
4. Further measures applicable to the carrying out of examinations under official supervision may be adopted in accordance with the procedure laid down in Article 21.
Until such measures are adopted, the conditions set out in Article 2 of Commission Decision 89/540/EEC shall be adhered to.`;
8. in Article 12a the first paragraph shall be replaced by the following:
'For the purpose of seeking improved alternatives to certain provisions set out in this Directive, it may be decided to organise temporary experiments under specified conditions at Community level in accordance with the provisions laid down in Article 21.`;
9. in Annex I the first sentence of point 5 shall be replaced by the following:
'5. The satisfaction of the abovementioned standards or other conditions shall, in the case of basic seed, be examined in official field inspections and, in the case of certified seed, be examined either in official field inspections or in inspections carried out under official supervision.`.
Article 6
Directive 70/457/EEC is hereby amended as follows:
In Article 9 the following paragraph shall be added:
'5. So far as the suitability of the denomination of a variety is concerned, Article 63 of Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights (*) shall apply.
Detailed implementing rules as to the suitability of denominations of varieties may be adopted in accordance with the procedure provided for in Article 23.
(*) OJ L 227, 1.9.1994, p. 1. Regulation as amended by Regulation (EC) No 2506/95 (OJ L 258, 28.10.1995, p. 3).`
Article 7
Directive 70/458/EEC is hereby amended as follows:
1. Article 2(1a) shall be replaced by the following:
'1a. Amendments to be made to the lists of species referred to in paragraph 1(A) shall be adopted in accordance with the procedure laid down in Article 40.`;
2. the first paragraph of Article 29a shall be replaced by the following:
'For the purpose of seeking improved alternatives to certain provisions set out in this directive, it may be decided to organise temporary experiments under specified conditions at Community level in accordance with the provisions laid down in Article 40.`;
3. in Article 10 the following paragraph shall be added:
'5. So far as the suitability of the denomination of a variety is concerned, Article 63 of Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights (*) shall apply.
Detailed implementing rules as to the suitability of denominations of varieties may be adopted in accordance with the procedure provided for in Article 40.
(*) OJ L 227, 1.9.1994, p. 1. Regulation as amended by Regulation (EC) No 2506/95 (OJ L 258, 28.10.1995, p. 3).`
Article 8
1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive before 1 February 2000. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The procedure for such reference shall be adopted by the Member States.
2. Member States shall communicate to the Commission the text of the main provisions of domestic law they adopt in the field covered by this Directive.
Article 9
No later than five years after the date of the entry into force of this Directive, the Commission shall submit a detailed evaluation of the simplifications of the certification procedures introduced thereby. This evaluation shall focus in particular on the possible effects on the quality of the seed.
Article 10
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 11
This Directive is addressed to the Member States.
|
[
"UKSI20001788",
"UKSI20001791",
"UKSI20001792",
"UKSI20001789",
"UKSI20001793",
"UKSI20001790"
] |
31998L0100
|
1998
|
Commission Directive 98/100/EC of 21 December 1998 amending Directive 92/76/EC recognising protected zones exposed to particular plant health risks in the Community
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), as last amended by Commission Directive 98/2/EC (2), and in particular the first subparagraph of Article 2(1)(h) thereof,
Having regard to Commission Directive 92/76/EEC of 6 October 1992 recognising protected zones exposed to particular plant health risks in the Community (3), as last amended by Directive 98/17/EC (4),
Whereas under Commission Directive 92/76/EEC, as amended, certain zones in Ireland and Italy were provisionally recognised as 'protected zones` in respect of certain harmful organisms for a period expiring on 31 December 1998;
Whereas, from information supplied by Austria, Ireland and Italy and from the survey monitoring information gathered by Commission experts it appears that the provisional recognition of the protected zones for Austria, Ireland and Italy in respect of Erwinia amylovora (Burr.) Winsl. et al. should be extended for a further limited period to enable the responsible official bodies of Austria, Ireland and Italy to complete the information on the distribution of Erwinia amylovora and to continue and complete their eradication programmes for this harmful organism in their respective countries, and to enable Commission experts to monitor and assess the effectiveness of such programmes;
Whereas, from information supplied by Finland and from the survey monitoring information gathered by Commission experts it has become apparent that the provisional recognition of the protected zone for Finland in respect of Globodera pallida (Stone) Behrens should be changed to a 'permanent` status and extended beyond 31 December 1998; whereas the necessity of such recognition shall be reviewed in the light of the outcome of the review of Council Directive 69/465/EEC of 8 December 1969 on the control of potato cyst eelworm (5) and the implementation thereof;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,
Article 1
Article 1 of Directive 92/76/EEC is amended as follows:
1. in the first subparagraph the words 'in the case of (b)2 for Ireland and the region of Apulia in Italy the said zones are recognised until 31 December 1998 and for Austria until 31 December 1998` are replaced by 'in the case of (b)2 for Austria, Ireland and the regions of Apulia, Emilia-Romagna, Lombardia and Veneto in Italy the said zones are recognised until 31 March 2000`;
2. the second subparagraph is replaced by the following:
'In the case of point (a)5b, the zone is recognised until 31 December 1996`.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 1 January 1999. They shall immediately inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The procedure for such a reference shall be adopted by Member States.
2. Member States shall immediately communicate to the Commission the essential provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof.
Article 3
This Directive shall enter into force on the day following its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI19931320"
] |
31998L0101
|
1998
|
Commission Directive 98/101/EC of 22 December 1998 adapting to technical progress Council Directive 91/157/EEC on batteries and accumulators containing certain dangerous substances (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 91/157/EEC of 18 March 1991 on batteries and accumulators containing certain dangerous substances (1), and in particular Article 10 thereof,
Whereas within the framework of the Act of Accession of Austria, Finland and Sweden, in particular in Articles 69 and 112, it is foreseen that during a period of four years from the date of accession the provisions concerning the mercury containing batteries referred to in Article 3 of Directive 91/157/EEC should be reviewed in accordance with EC procedures;
Whereas, in order to achieve a high level of environmental protection, the marketing of certain batteries should be prohibited, in view of the amount of mercury they contain; whereas that prohibition, in order to achieve its full effect for the environment, must cover appliances into which such batteries and accumulators are incorporated; whereas such prohibition may have a positive impact in facilitating the recovery of batteries;
Whereas the technical development of alternative heavy-metal-free batteries should be taken into account;
Whereas Directive 91/157/EEC should be adapted accordingly;
Whereas the measures provided for in this Directive are in accordance with the opinion expressed by the Committee established pursuant to Article 18 of Council Directive 75/442/EEC of 15 July 1975 on waste (2), as last amended by Commission Decision 96/350/EC (3),
Article 1
Directive 91/157/EEC is amended as follows:
1. Article 3(1) is replaced by the following:
'1. Member States shall prohibit, as from 1 January 2000 at the latest, the marketing of batteries and accumulators, containing more than 0,0005 % of mercury by weight, including in those cases where these batteries and accumulators are incorporated into appliances. Button cells and batteries composed of button cells with a mercury content of no more than 2 % by weight shall be exempted from this prohibition.`;
2. Annex I is replaced by the text in the Annex to this Directive.
Article 2
Member States shall adopt and publish, before 1 January 2000, the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20012551",
"UKSI20003097"
] |
31999L0007
|
1999
|
Commission Directive 1999/7/EC of 26 January 1999 adapting to technical progress Council Directive 70/311/EEC relating to the steering equipment for motor vehicles and their trailers (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 70/311/EEC of 8 June 1970 on the approximation of the laws of the Member States relating to the steering equipment for motor vehicles and their trailers (1), as last amended by Directive 92/62/EEC (2), and in particular Article 3 thereof,
Whereas Directive 70/311/EEC is one of the separate directives of the EC type-approval procedure which has been established by Council Directive 70/156/EEC (3), as last amended by Commission Directive 98/14/EC (4), relating to type-approval of motor vehicles and their trailers; whereas consequently the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to Directive 70/311/EEC;
Whereas, with a view to the practical application of Directive 70/311/EEC, it is necessary to ensure that uniform provisions are laid down which are also aligned with the latest version of UN-ECE Regulation No 79 in all Member States;
Whereas Annex VII to Directive 70/156/EEC lays down the format and the contents of the EC type-approval number; whereas the same specifications should be adopted for the purposes of this Directive;
Whereas Directive 70/311/EEC should be adapted accordingly;
Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress established by Directive 70/156/EEC,
Article 1
Directive 70/311/EEC is hereby amended as follows:
1. Article 1 is replaced by the following:
'Article 1
For the purpose of this Directive, "vehicle" means any vehicle as defined in Article 2 of Directive 70/156/EEC.`;2. in Article 3, 'Annex` is replaced by 'Annexes`;
3. the Annexes are amended in accordance with the Annex to this Directive.
Article 2
1. With effect from 1 January 1999, Member States may not on grounds relating to the steering equipment:
- refuse, in respect of a type of vehicle, to grant EC type-approval or national type-approval, or
- prohibit the sale, registration, entry into service of vehicles
if the vehicles comply with the requirements of Directive 70/311/EEC as amended by this Directive.
2. With effect from 1 October 2000, Member States:
- shall no longer grant EC type-approval, and
- may refuse to grant national type-approval
for a new type of vehicle on grounds relating to the steering equipment if the requirements of Directive 70/311/EEC as amended by this Directive are not fulfilled.
3. With effect from 1 October 2001, Member States may refuse the registration, sale or entry into service of new vehicles of category M2, M3, N2, or N3 equipped with auxiliary steering equipment which does not comply with the provisions of Directive 70/311/EEC as amended by this Directive.
Article 3
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 1999 at the latest. They shall forthwith inform the Commission thereof.
When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive.
Article 4
This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.
Article 5
This Directive is addressed to the Member States.
|
[
"UKSI19992324"
] |
31999L0008
|
1999
|
Commission Directive 1999/8/EC of 18 February 1999 amending Council Directive 66/402/EEC on the marketing of cereal seed
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (1), as last amended by Council Directive 98/96/EC (2), and in particular Article 21(a) thereof,
Whereas, in the case of triticale seed intended for marketing in their own territory, Member States may reduce to 80 % the minimum germination required under Annex II;
Whereas this possibility will be no longer granted from 1 February 2000, pursuant to the abovementioned Directive;
Whereas, according to present scientific and technical knowledge, it appears difficult to produce in the Community seed of triticale with a germination capacity equal to that required under Annex II;
Whereas, in the light of the development of scientific and technical knowledge it is appropriate to reduce the minimum germination capacity of pure seed to 80 %;
Whereas the measures provided in this Directive are in accordance with the opinion of the Standing Committee on seeds and propagating material for agriculture, horticulture and forestry,
Article 1
Section (2)(A) of Annex II to Directive 66/402/EEC is amended as follows: In the case of triticosecale the figures '85` in the column 2 shall be replaced by '80`.
Article 2
1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with the provisions of this Directive by 1 February 2000 at the latest. They shall forthwith inform the Commission thereof.
When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive is addressed to the Member States.
|
[
"UKSI19992196"
] |
31999L0002
|
1999
|
Directive 1999/2/EC of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation
Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the Economic and Social Committee (2),
Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), in the light of the joint text approved by the Conciliation Committee on 9 December 1998,
(1) Whereas differences between national laws relating to the treatment of foodstuffs by ionising radiation and its conditions of use hinder the free movement of foodstuffs and may create conditions of unequal competition, thereby directly affecting the operation of the internal market;
(2) Whereas it is necessary to adopt measures aimed at the smooth operation of the internal market; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured; whereas this is not the case at present because of the differences in treatment in the Member States, irradiation of foodstuffs being allowed in some and banned in others;
(3) Whereas this framework Directive will be completed by Directive 1999/3/EC of the European Parliament and of the Council of 22 February 1999 on the establishment of a Community list of foods and food ingredients treated with ionising radiation (4), hereinafter referred to as 'the implementing Directive`;
(4) Whereas in several Member States foodstuff irradiation constitutes a sensitive issue in public debate, and whereas consumers may have cause for concern about the consequences of the use of food irradiation;
(5) Whereas, until the entry into force of the Community positive list of foodstuffs which may be treated with ionising radiation, it is appropriate that Member States may, in compliance with the rules of the Treaty, continue to apply existing national restrictions or bans on ionising radiation of foodstuffs and on trade in irradiated foodstuffs which are not included in the initial positive list established by the implementing Directive;
(6) Whereas rules relating to the use of ionising radiation for the treatment of foodstuffs should take account primarily of human health requirements but also, within the limits required for the protection of health, of economic and technical needs;
(7) Whereas Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation (5) is applicable;
(8) Whereas approved irradiation units should be subject to an official control, through an inspection system to be created for the needs of this Directive;
(9) Whereas approved units should keep records to ensure that the rules of this Directive have been respected;
(10) Whereas Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (6) has already laid down rules concerning the labelling of irradiated foodstuffs for sale to the ultimate consumer;
(11) Whereas appropriate rules must also be laid down for the labelling of foodstuffs treated with ionising radiation not intended for the ultimate consumer;
(12) Whereas, without prejudice to the decision-making procedures laid down in the Treaty establishing the European Community or in this Directive, the Scientific Committee for Food set up by Decision 74/234/EEC (7) should be consulted on any question relating to this Directive which may have an effect on public health;
(13) Whereas foodstuffs may only be treated by the action of ionising radiation if there is a food hygiene need, or a demonstrable technological or other advantage, or benefit to the consumer and if they are wholesome and in a proper condition, since ionising radiation should not be used as a substitute for hygiene or health practices or good manufacturing or agricultural practice;
(14) Whereas the process should not be used as a substitute for good manufacturing practice, and whereas this condition is fulfilled for foodstuffs listed in the Annex to the implementing Directive;
(15) Whereas, in all cases where the Council empowers the Commission to implement rules relating to food irradiation, provision should be made for a procedure instituting close cooperation between Member States and the Commission within the Standing Committee on Foodstuffs, and, where necessary, the Standing Veterinary Committee or the Standing Committee on Plant Health;
(16) Whereas should the use of the process or of a foodstuff treated with ionising radiation authorised on the basis of this Directive appear to constitute a health risk, Member States should be authorised to suspend or limit such use, or to reduce the limits, pending a decision at Community level;
(17) Whereas Council Directive 89/397/EEC of 14 June 1989 on the official control of foodstuffs (8) leaves the choice of means and methods to the national enforcement authorities; whereas Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs (9) lays down quality standards for laboratories and requires the use of validated methods of analysis where available; whereas Article 5 of the latter Directive is applicable to the monitoring of the implementation of this Directive;
(18) Whereas a modus vivendi between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the Treaty (10) was concluded on 20 December 1994,
Article 1
1. This Directive shall apply to the manufacture, marketing and importation of foods and food ingredients, hereinafter called 'foodstuffs`, treated with ionising radiation.
2. This Directive shall not apply to:
(a) foodstuffs exposed to ionising radiation generated by measuring or inspection devices, provided that the dose absorbed is not greater than 0,01 Gy for inspection devices which utilise neutrons and 0,5 Gy in other cases, at a maximum radiation energy level of 10 MeV in the case of X-rays, 14 MeV in the case of neutrons and 5 MeV in other cases;
(b) the irradiation of foodstuffs which are prepared for patients requiring sterile diets under medical supervision.
Article 2
Member States shall take all measures necessary to ensure that irradiated foodstuffs can be placed on the market only if they comply with the provisions of this Directive.
Article 3
1. The conditions which must be fulfilled for authorisation of the treatment of foodstuffs with ionising radiation are set out in Annex I. At the time of treatment such foodstuffs must be in a suitably wholesome state.
2. Irradiation may be carried out only by means of the sources listed in Annex II and in accordance with the requirements of the Code of Practice referred to in Article 7(2). The overall average absorbed dose shall be calculated in accordance with Annex III.
Article 4
1. The Community list of foodstuffs which may be treated with ionising radiation to the exclusion of all others and the maximum radiation doses authorised shall be defined in the implementing Directive, which shall be adopted in accordance with the procedure laid down in Article 100a of the Treaty taking account of the authorisation conditions set out in Annex I.
2. This list shall be established in stages.
3. The Commission shall examine the national authorisations in force and, after consulting the Scientific Committee for Food, submit in accordance with the procedure laid down in Article 100a of the Treaty proposals aiming at establishing the list.
At the latest 31 December 2000, the Commission shall, in accordance with Article 100a of the Treaty, submit a proposal intended to complete the positive list provided for in paragraph 1.
4. Until entry into force of the Directive adopted on the basis of the proposal referred to in the second subparagraph of paragraph 3, Member States may maintain existing authorisations concerning the treatment of foodstuffs with ionising radiation provided that:
(a) the treatment of the foodstuff concerned has been subject to a favourable opinion of the Scientific Committee for Food;
(b) the overall average absorbed radiation dose does not exceed the limit values recommended by the Scientific Committee for Food;
(c) ionising radiation and placing on the market are effected in accordance with this Directive.
5. Until entry into force of the Directive adopted on the basis of the proposal referred to in the second subparagraph of paragraph 3, any Member State may also authorise the treatment of foodstuffs for which authorisations have been maintained by another Member State in accordance with paragraph 4, where the conditions referred to in paragraph 4 are fulfilled.
6. Member States shall forthwith notify the Commission and the other Member States of authorisations maintained under paragraph 4 or granted under paragraph 5 and of conditions attaching to them. The Commission shall publish these notifications in the Official Journal of the European Communities.
7. Until the entry into force of the Directive adopted on the basis of the proposal referred to in the second subparagraph of paragraph 3, Member States may, in compliance with the rules of the Treaty, continue to apply existing national restrictions or bans on ionising radiation of foodstuffs and on trade in irradiated foodstuffs which are not included in the initial positive list established by the implementing Directive.
Article 5
1. The maximum radiation dose for foodstuffs may be given in partial doses; however, the maximum radiation dose fixed in accordance with Article 4 must not be exceeded. Irradiation treatment may not be used in combination with any chemical treatment having the same purpose as that treatment.
2. Exceptions to paragraph 1 may be decided on in accordance with the procedure laid down in Article 12.
Article 6
The labelling of foodstuffs treated with ionising radiation shall be governed by the following provisions:
1. in the case of products intended for the ultimate consumer and mass caterers:
(a) if the products are sold as items, the words 'irradiated` or 'treated with ionising radiation` shall appear on the label as provided for in Article 5(3) of Directive 79/112/EEC.
In the case of products sold in bulk, these words shall appear together with the name of the product on a display or notice above or beside the container in which the products are placed;
(b) if an irradiated product is used as an ingredient, the same words shall accompany its designation in the list of ingredients.
In the case of products sold in bulk, these words shall appear together with the name of the product on a display or notice above or beside the container in which the products are placed;
(c) by way of derogation from Article 6(7) of Directive 79/112/EEC, the same words shall be required in order to indicate the irradiated ingredients used in compound ingredients in foodstuffs, even if these constitute less than 25 % of the finished product;
2. in the case of products not intended for the ultimate consumer and mass caterers:
(a) the words provided for in the previous paragraph shall be used to indicate treatment of both the foods and the ingredients contained in a non-irradiated foodstuff;
(b) either the identity and address of the facility which carried out the irradiation or its reference number as provided for in Article 7 shall be indicated;
3. the indication of treatment shall in all cases be given on the documents which accompany or refer to irradiated foodstuffs.
Article 7
1. Member States shall inform the Commission of the competent authority or authorities responsible for:
- prior approval of irradiation facilities,
- the allocation of an official reference number for approved irradiation facilities,
- official control and inspection,
- withdrawal or modification of approval.
2. Approval shall be granted only if the facility:
- meets the requirements of the Joint FAO/WHO Codex Alimentarius Commission Recommended International Code of Practice for the operation of irradiation facilities used for the treatment of foods (reference FAO/WHO/CAC,vol.XV edition 1), and any supplementary requirements which may be adopted in accordance with the procedure laid down in Article 12 of this Directive,
- designates a person responsible for compliance with all the conditions necessary for application of the process.
3. Each Member State shall forward to the Commission:
- the names, addresses and reference numbers of the irradiation facilities which it has approved, the text of the approval document, and any decision suspending or withdrawing approval.
Furthermore the Member States shall forward to the Commission every year:
- the results of checks carried out in the ionising irradiation facilities, in particular regarding the categories and quantities of products treated and the doses administered,
- the results of checks carried out at the product marketing stage. Member States shall ensure that the methods used to detect treatment with ionising radiation comply with paragraphs 1 and 2 of the Annex to Directive 85/591/EEC (11) and are standardised or validated either already or as soon as possible, up to 1 January 2003 at the latest. Member States shall inform the Commission of the methods used and the Commission shall assess the use and development of these methods having regard to an opinion of the Scientific Committee for Food.
4. On the basis of the data supplied in accordance with paragraph 3, the Commission shall publish in the Official Journal of the European Communities:
- the details of the facilities as well as any changes in their status,
- a report based on the information provided every year by the national supervisory authorities.
Article 8
1. Irradiation facilities approved in accordance with Article 7 must, for each source of ionising radiation used, keep a record showing for each batch of foodstuffs treated:
(a) the nature and quantity of foodstuffs irradiated;
(b) the batch number;
(c) the person ordering the irradiation treatment;
(d) the recipient of the treated foodstuffs;
(e) the date of irradiation;
(f) the packaging materials used during treatment;
(g) the data for control of the irradiation process as provided for in Annex III, the dosimetric checks carried out and the results obtained, with details in particular of the limits, lower and upper, of the dose absorbed and the type of ionising radiation;
(h) reference to the initial dose validation measurements.
2. The records referred to in paragraph 1 must be kept for a period of five years.
3. Detailed rules for the application of this Article shall be adopted in accordance with the procedure laid down in Article 12.
Article 9
1. A foodstuff treated with ionising radiation may not be imported from a third country unless it:
- complies with the conditions which apply to those foodstuffs,
- is accompanied by documents showing the name and address of the facility which carried out the irradiation treatment and providing the information referred to in Article 8,
- was treated in an irradiation facility approved by the Community and appearing on the list referred to in paragraph 2 of this Article.
2. (a) In accordance with the procedure laid down in Article 12, the Commission shall draw up the list of approved facilities for which official supervision guarantees that the requirements of Article 7 are complied with.
For the purpose of drawing up this list, the Commission may instruct experts to carry out, under its authority, evaluations and inspections of irradiation facilities in third countries in accordance with Article 5 of Directive 93/99/EEC.
The Commission shall publish that list and any amendments thereto in the Official Journal of the European Communities.
(b) The Commission may conclude technical arrangements with the competent organisations in third countries on the procedures whereby the evaluations and inspections referred to in (a) are to be carried out.
Article 10
Materials used for packaging foodstuffs to be irradiated must be suitable for the purpose.
Article 11
Amendments to the Annexes to take account of scientific and technical progress shall be adopted in accordance with the procedure laid down in Article 100a of the Treaty.
Article 12
1. Where the procedure defined in this Article is to be followed, the Commission shall be assisted by the Standing Committee on Foodstuffs, hereinafter referred to as 'the Committee`.
The Chairman shall, without delay, refer the matter to the Committee, either on his own initiative or at the request of the representative of a Member State.
2. The representative of the Commission shall submit to the Committee a draft of the measures to be adopted. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
(b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.
Article 13
The Scientific Committee for Food shall be consulted on any matter falling within the scope of this Directive likely to have an effect on public health.
Article 14
1. Where a Member State, as a result of new information or of a reassessment of existing information made since this Directive was adopted, has clear proof that the irradiation of certain foodstuffs endangers human health although it complies with the provisions of this Directive, that Member State may temporarily suspend or restrict application of the provisions in question in its territory. It shall immediately inform the other Member States and the Commission thereof, giving grounds for its decision.
2. The Commission shall examine the grounds referred to in paragraph 1 as soon as possible within the Standing Committee on Foodstuffs; it shall take the appropriate measures in accordance with the procedure laid down in Article 12. The Member State which took the decision referred to in paragraph 1 may maintain it until the measures have entered into force.
3. Amendments to this Directive or to the implementing Directive may be made in accordance with the procedure laid down in Article 12 only to the extent necessary to ensure the protection of public health and shall in any event be limited to prohibitions or restrictions as compared to the previous legal situation.
Article 15
Member States shall bring into force their laws, regulations and administrative provisions to comply with this Directive in such a way as to:
- permit the marketing and use of irradiated foodstuffs by 20 September 2000,
- prohibit the marketing and use of irradiated foodstuffs not complying with this Directive by 20 March 2001.
They shall inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
Article 16
This Directive shall enter into force on the seventh day following its publication in the Official Journal of the European Communities.
Article 17
This Directive is addressed to the Member States.
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[
"UKSI20002254"
] |
31999L0003
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1999
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DIRECTIVE 1999/3/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 February 1999 on the establishment of a Community list of foods and food ingredients treated with ionising radiation
Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the Economic and Social Committee (2),
Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), in the light of the joint text approved by the Conciliation Committee on 9 December 1998,
Whereas Article 4(1) and (2) of Directive 1999/2/EC of the European Parliament and of the Council of 22 February 1999 on the approximation of the laws of the Member States concerning foods and food ingredients treated with ionising radiation (4) hereinafter referred to as ‘the framework Directive’ provides for the adoption of a list of foodstuffs which, to the exclusion of all other, may be treated with ionising radiation; whereas this list shall be established in stages;
Whereas dried aromatic herbs, spices and vegetable seasonings are frequently contaminated and/or infested with organisms and their metabolites which are harmful to public health;
Whereas such contamination and/or infestation can no longer be treated with fumigants such as ethylene oxide because of the toxic potential of their residues;
Whereas the use of ionising radiation is an effective means of replacing the said substances;
Whereas such treatment has been accepted by the Scientific Committee for Food;
Whereas such treatment is therefore in the interest of public health protection,
Article 1
1. Without prejudice to the Community positive list to be established in accordance with the second subparagraph of Article 4(3) of the framework Directive, this Directive establishes a Community initial positive list of food and food ingredients, hereinafter referred to as ‘foodstuffs’, that may be treated with ionising radiation, together with the maximum doses authorised for the intended purpose.
2. Treatment of the products in question with ionising radiation may be carried out only in accordance with the provisions of the framework Directive. In particular, test methods shall be used in accordance with Article 7(3) of the framework Directive.
3. The foodstuffs that may be treated with ionising radiation and the maximum overall average dose that may be imparted are listed in the Annex.
Article 2
Member States may not prohibit, resrict or hinder the marketing of foodstuffs irradiated in accordance with the general provisions of the framework Directive and the provisions of this Directive on the grounds that they have been so treated.
Article 3
Any amendments to this Directive, shall be made in accordance with the procedures laid down in Article 100a of the Treaty.
Article 4
Member States shall bring into force the laws, regulations and administrative provisions to comply with this Directive in such a way as to permit the marketing and use of irradiated foodstuffs which comply with this Directive by 20 September 2000.
They shall inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
Article 5
This Directive shall enter into force on the seventh day following its publication in the Official Journal of the European Communities.
Article 6
This Directive is addressed to the Member States.
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[
"UKSI20002254"
] |
31999L0005
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1999
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Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity
Having regard to the Treaty establishing the European Community, and in particular Article 100a,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 189b of the Treaty(3), in the light of the joint text approved by the Conciliation Committee on 8 December 1998,
(1) Whereas the radio equipment and telecommunications terminal equipment sector is an essential part of the telecommunications market, which is a key element of the economy in the Community; whereas the directives applicable to the telecommunications terminal equipment sector are no longer capable of accommodating the expected changes in the sector caused by new technology, market developments and network legislation;
(2) Whereas in accordance with the principles of subsidiarity and proportionality referred to in Article 3b of the Treaty, the objective of creating an open competitive single market for telecommunications equipment cannot be sufficiently achieved by the Member States and can therefore be better achieved by the Community; whereas this Directive does not go beyond what is necessary to achieve this aim;
(3) Whereas Member States may rely upon Article 36 of the Treaty to exclude certain classes of equipment from this Directive;
(4) Whereas Directive 98/13/EC(4) consolidated the provisions relating to telecommunications terminal equipment and satellite earth station equipment, including measures for the mutual recognition of their conformity;
(5) Whereas that Directive does not cover a substantial proportion of the radio equipment market;
(6) Whereas dual-use goods are subject to the Community regime of export controls introduced by Council Regulation (EC) No 3381/94(5);
(7) Whereas the broad scope of this Directive requires new definitions of the expressions "radio equipment" and "telecommunications terminal equipment"; whereas a regulatory regime aimed at the development of a single market for radio equipment and telecommunications terminal equipment should permit investment, manufacture and sale to take place at the pace of technology and market developments;
(8) Whereas, given the increasing importance of telecommunications terminal equipment and networks using radio transmission besides equipment connected through wired links, any rules governing the manufacturing, marketing and use of radio equipment and telecommunications terminal equipment should cover both classes of such equipment;
(9) Whereas Directive 98/10/EC of the European Parliament and of the Council of 26 February 1998 on the application of open network provision (ONP) to voice telephony and on universal service for telecommunications in a competitive environment(6) calls on national regulatory authorities to ensure the publication of details of technical interface specifications for network access for the purpose of ensuring a competitive market for the supply of terminal equipment;
(10) Whereas the objectives of Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits(7) are sufficient to cover radio equipment and telecommunications terminal equipment, but with no lower voltage limit applying;
(11) Whereas the electromagnetic compatibility related protection requirements laid down by Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of Member States relating to electromagnetic compatibility(8) are sufficient to cover radio equipment and telecommunications terminal equipment;
(12) Whereas Community law provides that obstacles to the free movement of goods within the Community, resulting from disparities in national legislation relating to the marketing of products, can only be justified where any national requirements are necessary and proportionate; whereas, therefore, the harmonisation of laws must be limited to those requirements necessary to satisfy the essential requirements relating to radio equipment and telecommunications terminal equipment;
(13) Whereas the essential requirements relevant to a class of radio equipment and telecommunications terminal equipment should depend on the nature and the needs of that class of equipment; whereas these requirements must be applied with discernment in order not to inhibit technological innovation or the meeting of the needs of a free-market economy;
(14) Whereas care should be taken that radio equipment and telecommunications terminal equipment should not represent an avoidable hazard to health;
(15) Whereas telecommunications are important to the well-being and employment of people with disabilities who represent a substantial and growing proportion of the population of Europe; whereas radio equipment and telecommunications terminal equipment should therefore in appropriate cases be designed in such a way that disabled people may use it without or with only minimal adaptation;
(16) Whereas radio equipment and telecommunications terminal equipment can provide certain functions required by emergency services;
(17) Whereas some features may have to be introduced on the radio equipment and telecommunications terminal equipment in order to prevent the infringement of personal data and privacy of the user and of the subscriber and/or the avoidance of fraud;
(18) Whereas in some cases interworking via networks with other apparatus within the meaning of this Directive and connection with interfaces of the appropriate type throughout the Community may be necessary;
(19) Whereas it should therefore be possible to identify and add specific essential requirements on user privacy, features for users with a disability, features for emergency services and/or features for avoidance of fraud;
(20) Whereas it is recognised that in a competitive market, voluntary certification and marking schemes developed by consumer organisations, manufacturers, operators and other industry actors contribute to quality and are a useful means of improving consumers' confidence in telecommunications products and services; whereas Member States may support such schemes; whereas such schemes should be compatible with the competition rules of the Treaty;
(21) Whereas unacceptable degradation of service to persons other than the user of radio equipment and telecommunications terminal equipment should be prevented; whereas manufacturers of terminals should construct equipment in a way which prevents networks from suffering harm which results in such degradation when used under normal operating conditions; whereas network operators should construct their networks in a way that does not oblige manufacturers of terminal equipment to take disproportionate measures to prevent networks from being harmed; whereas the European Telecommunications Standards Institute (ETSI) should take due account of this objective when developing standards concerning access to public networks;
(22) Whereas effective use of the radio spectrum should be ensured so as to avoid harmful interference; whereas the most efficient possible use, according to the state of the art, of limited resources such as the radio frequency spectrum should be encouraged;
(23) Whereas harmonised interfaces between terminal equipment and telecommunications networks contribute to promoting competitive markets both for terminal equipment and network services;
(24) Whereas, however, operators of public telecommunications networks should be able to define the technical characteristics of their interfaces, subject to the competition rules of the Treaty; whereas, accordingly, they should publish accurate and adequate technical specifications of such interfaces so as to enable manufacturers to design telecommunications terminal equipment which satisfies the requirements of this Directive;
(25) Whereas, nevertheless, the competition rules of the Treaty and Commission Directive 88/301/EEC of 16 May 1988 on competition in the markets in telecommunications terminal equipment(9) establish the principle of equal, transparent and non-discriminatory treatment of all technical specifications having regulatory implications; whereas therefore it is the task of the Community and the Member States, in consultation with the economic players, to ensure that the regulatory framework created by this Directive is fair;
(26) Whereas it is the task of the European standardisation organisations, notably ETSI, to ensure that harmonised standards are appropriately updated and drafted in a way which allows for unambiguous interpretation; whereas maintenance, interpretation and implementation of harmonised standards constitute very specialised areas of increasing technical complexity; whereas those tasks require the active participation of experts drawn from amongst the economic players; whereas in some circumstances it may be necessary to provide more urgent interpretation of or corrections to harmonised standards than is possible through the normal procedures of the European standardisation organisations operating in conformity with Directive 98/34/EC of 22 June 1998 of the European Parliament and of the Council laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services(10);
(27) Whereas it is in the public interest to have harmonised standards at European level in connection with the design and manufacture of radio equipment and telecommunications terminal equipment; whereas compliance with such harmonised standards gives rise to a presumption of conformity to the essential requirements; whereas other means of demonstrating conformity to the essential requirements are permitted;
(28) Whereas the assignment of equipment class identifiers should draw on the expertise of CEPT/ERC and of the relevant European standards bodies in radio matters; whereas other forms of cooperation with those bodies is to be encouraged where possible;
(29) Whereas, in order to enable the Commission to monitor market control effectively, the Member States should provide the relevant information concerning types of interfaces, inadequate or incorrectly applied harmonised standards, notified bodies and surveillance authorities;
(30) Whereas notified bodies and surveillance authorities should exchange information on radio equipment and telecommunications terminal equipment with a view to efficient surveillance of the market; whereas such cooperation should make the utmost use of electronic means; whereas, in particular, such cooperation should enable national authorities to be informed about radio equipment placed on their market operating in frequency bands not harmonised in the Community;
(31) Whereas manufacturers should notify Member States of their intention to place radio equipment on the market using frequency bands whose use is not harmonised throughout the Community; whereas Member States therefore need to put in place procedures for such notification; whereas such procedures should be proportionate and should not constitute a conformity assessment procedure additional to those provided for in Annexes IV or V; whereas it is desirable that those notification procedures should be harmonised and preferably implemented by electronic means and one-stop-shopping;
(32) Whereas radio equipment and telecommunications terminal equipment which complies with the relevant essential requirements should be permitted to circulate freely; whereas such equipment should be permitted to be put into service for its intended purpose; whereas the putting into service may be subject to authorisations on the use of the radio spectrum and the provision of the service concerned;
(33) Whereas, for trade fairs, exhibitions, etc., it must be possible to exhibit radio equipment and telecommunications terminal equipment which does not conform to this Directive; whereas, however, interested parties should be properly informed that such equipment does not conform and cannot be purchased in that condition; whereas Member States may restrict the putting into service, including the switching on, of such exhibited radio equipment for reasons related to the effective and appropriate use of the radio spectrum, avoidance of harmful interference or matters relating to public health;
(34) Whereas radio frequencies are allocated nationally and, to the extent that they have not been harmonised, remain within the exclusive competence of the Member States; whereas it is necessary to include a safeguard provision permitting Member States, in conformity with Article 36 of the Treaty, to prohibit, restrict or require the withdrawal from its market of radio equipment which has caused, or which it reasonably considers will cause, harmful interference; whereas interference with nationally allocated radio frequencies constitutes a valid ground for Member States to take safeguard measures;
(35) Whereas manufacturers are liable for damage caused by defective apparatus according to the provisions of Council Directive 85/374/EEC(11); whereas without prejudice to any liability on the part of the manufacturer, any person who imports apparatus into the Community for sale in the course of his business is liable according to that Directive; whereas the manufacturer, his authorised representative or the person responsible for placing the apparatus on the Community market is liable according to the rules of the law of contractual or non-contractual liability in the Member States;
(36) Whereas the measures which are appropriate to be taken by the Member States or the Commission where apparatus declared to be compliant with the provisions of this Directive causes serious damage to a network or harmful radio interference shall be determined in accordance with the general principles of Community law, in particular, the principles of objectivity, proportionality and non-discrimination;
(37) Whereas on 22 July 1993 the Council adopted Decision 93/465/EEC concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and the use of EC conformity marking which are intended to be used in the technical harmonisation directives(12); whereas the applicable conformity assessment procedures should preferably be chosen from among the available modules laid down by that Decision;
(38) Whereas Member States may request that notified bodies they designate and their surveillance authorities be accredited according to appropriate European standards;
(39) Whereas it is appropriate that compliance of radio equipment and telecommunications terminal equipment with the requirements of Directives 73/23/EEC and 89/336/EEC may be demonstrated using the procedures specified in those Directives where the apparatus is within their scope; whereas, as a result, the procedure provided for in Article 10(1) of Directive 89/336/EEC may be used where the application of harmonised standards gives rise to a presumption of conformity with the protection requirements; whereas the procedure provided for in Article 10(13) may be used where the manufacturer has not applied harmonised standards or where no such standards exist;
(40) Whereas Community undertakings should have effective and comparable access to third countries' markets and enjoy treatment in third countries similar to that offered in the Community to undertakings owned wholly, controlled through majority ownership or effectively controlled by nationals of the third countries concerned;
(41) Whereas it is desirable to establish a committee bringing together parties directly involved in the implementation of regulation of radio equipment and telecommunications terminal equipment, in particular the national conformity assessment bodies and national bodies responsible for market surveillance, in order to assist the Commission in achieving a harmonised and proportionate application of the provisions so as to meet the needs of the market and the public at large; whereas representatives of telecommunications operators, users, consumers, manufacturers and service providers should be consulted where appropriate;
(42) Whereas a modus vivendi between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the Treaty was concluded on 20 December 1994(14);
(43) Whereas the Commission should keep under review the implementation and practical application of this and other relevant directives and take steps to ensure coordination of the application of all relevant directives in order to avoid disturbance to telecommunications equipment which affects the health of humans or is harmful to property;
(44) Whereas the functioning of this Directive should be reviewed in due course in the light of the development of the telecommunications sector and of experience gained from application of the essential requirements and the conformity assessment procedures provided for in this Directive;
(45) Whereas it is necessary to ensure that with the introduction of changes to the regulatory regime there is a smooth transition from the previous regime in order to avoid disruption to the market and legal uncertainty;
(46) Whereas this Directive replaces Directive 98/13/EC, which should accordingly be repealed; whereas Directives 73/23/EEC and 89/336/EEC will no longer apply to apparatus within the scope of this Directive, with the exception of protection and safety requirements and certain conformity assessment procedures,
CHAPTER I
GENERAL ASPECTS
Article 1
Scope and aim
1. This Directive establishes a regulatory framework for the placing on the market, free movement and putting into service in the Community of radio equipment and telecommunications terminal equipment.
2. Where apparatus as defined in Article 2(a) incorporates, as an integral part, or as an accessory:
(a) a medical device within the meaning of Article 1 of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(15), or
(b) an active implantable medical device within the meaning of Article 1 of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices(16),
the apparatus shall be governed by this Directive, without prejudice to the application of Directives 93/42/EEC and 90/385/EEC to medical devices and active implantable medical devices, respectively.
3. Where apparatus constitutes a component or a separate technical unit of a vehicle within the meaning of Council Directive 72/245/EEC(17) relating to the radio interference (electromagnetic compatibility) of vehicles or a component or a separate technical unit of a vehicle within the meaning of Article 1 of Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two or three-wheel motor vehicles, the apparatus shall be governed by this Directive without prejudice to the application of Directive 72/245/EEC or of Directive 92/61/EEC respectively.
4. This Directive shall not apply to equipment listed in Annex I.
5. This Directive shall not apply to apparatus exclusively used for activities concerning public security, defence, State security (including the economic well-being of the State in the case of activities pertaining to State security matters) and the activities of the State in the area of criminal law.
Article 2
Definitions
For the purpose of this Directive the following definitions shall apply:
(a) "apparatus" means any equipment that is either radio equipment or telecommunications terminal equipment or both;
(b) "telecommunications terminal equipment" means a product enabling communication or a relevant component thereof which is intended to be connected directly or indirectly by any means whatsoever to interfaces of public telecommunications networks (that is to say, telecommunications networks used wholly or partly for the provision of publicly available telecommunications services);
(c) "radio equipment" means a product, or relevant component thereof, capable of communication by means of the emission and/or reception of radio waves utilising the spectrum allocated to terrestrial/space radiocommunication;
(d) "radio waves" means electromagnetic waves of frequencies from 9 kHz to 3000 GHz, propagated in space without artificial guide;
(e) "interface" means
(i) a network termination point, which is a physical connection point at which a user is provided with access to public telecommunications network, and/or
(ii) an air interface specifying the radio path between radio equipment
and their technical specifications;
(f) "equipment class" means a class identifying particular types of apparatus which under this Directive are considered similar and those interfaces for which the apparatus is designed. Apparatus may belong to more than one equipment class;
(g) "technical construction file" means a file describing the apparatus and providing information and explanations as to how the applicable essential requirements have been implemented;
(h) "harmonised standard" means a technical specification adopted by a recognised standards body under a mandate from the Commission in conformity with the procedures laid down in Directive 98/34/EC for the purpose of establishing a European requirement, compliance with which is not compulsory.
(i) "harmful interference" means interference which endangers the functioning of a radionavigation service or of other safety services or which otherwise seriously degrades, obstructs or repeatedly interrupts a radiocommunications service operating in accordance with the applicable Community or national regulations.
Article 3
Essential requirements
1. The following essential requirements are applicable to all apparatus:
(a) the protection of the health and the safety of the user and any other person, including the objectives with respect to safety requirements contained in Directive 73/23/EEC, but with no voltage limit applying;
(b) the protection requirements with respect to electromagnetic compatibility contained in Directive 89/336/EEC.
2. In addition, radio equipment shall be so constructed that it effectively uses the spectrum allocated to terrestrial/space radio communication and orbital resources so as to avoid harmful interference.
3. In accordance with the procedure laid down in Article 15, the Commission may decide that apparatus within certain equipment classes or apparatus of particular types shall be so constructed that:
(a) it interworks via networks with other apparatus and that it can be connected to interfaces of the appropriate type throughout the Community; and/or that
(b) it does not harm the network or its functioning nor misuse network resources, thereby causing an unacceptable degradation of service; and/or that
(c) it incorporates safeguards to ensure that the personal data and privacy of the user and of the subscriber are protected; and/or that
(d) it supports certain features ensuring avoidance of fraud; and/or that
(e) it supports certain features ensuring access to emergency services; and/or that
(f) it supports certain features in order to facilitate its use by users with a disability.
Article 4
Notification and publication of interface specifications
1. Member States shall notify the interfaces which they have regulated to the Commission insofar as the said interfaces have not been notified under the provisions of Directive 98/34/EC. After consulting the committee in accordance with the procedure set out in Article 15, the Commission shall establish the equivalence between notified interfaces and assign an equipment class identifier, details of which shall be published in the Official Journal of the European Communities.
2. Each Member State shall notify to the Commission the types of interface offered in that State by operators of public telecommunications networks. Member States shall ensure that such operators publish accurate and adequate technical specifications of such interfaces before services provided through those interfaces are made publicly available, and regularly publish any updated specifications. The specifications shall be in sufficient detail to permit the design of telecommunications terminal equipment capable of utilising all services provided through the corresponding interface. The specifications shall include, inter alia, all the information necessary to allow manufacturers to carry out, at their choice, the relevant tests for the essential requirements applicable to the telecommunications terminal equipment. Member States shall ensure that those specifications are made readily available by the operators.
Article 5
Harmonised standards
1. Where apparatus meets the relevant harmonised standards or parts thereof whose reference numbers have been published in the Official Journal of the European Communities, Member States shall presume compliance with those of the essential requirements referred to in Article 3 as are covered by the said harmonised standards or parts thereof.
2. Where a Member State or the Commission considers that conformity with a harmonised standard does not ensure compliance with the essential requirements referred to in Article 3 which the said standard is intended to cover, the Commission or the Member State concerned shall bring the matter before the committee.
3. In the case of shortcomings of harmonised standards with respect to the essential requirements, the Commission may, after consulting the committee and in accordance with the procedure laid down in Article 14, publish in the Official Journal of the European Communities guidelines on the interpretation of harmonised standards or the conditions under which compliance with that standard raises a presumption of conformity. After consultation of the committee and in accordance with the procedure laid down in Article 14, the Commission may withdraw harmonised standards by publication of a notice in the Official Journal of the European Communities.
Article 6
Placing on the market
1. Member States shall ensure that apparatus is placed on the market only if it complies with the appropriate essential requirements identified in Article 3 and the other relevant provisions of this Directive when it is properly installed and maintained and used for its intended purpose. It shall not be subject to further national provisions in respect of placing on the market.
2. In taking a decision regarding the application of essential requirements under Article 3(3), the Commission shall determine the date of application of the requirements. If it is determined that an equipment class needs to comply with particular essential requirements under Article 3(3), any apparatus of the equipment class in question which is first placed on the market before the date of application of the Commission's determination can continue to be placed on the market for a reasonable period. Both the date of application and the period shall be determined by the Commission in accordance with the procedure laid down in Article 14.
3. Member States shall ensure that the manufacturer or the person responsible for placing the apparatus on the market provides information for the user on the intended use of the apparatus, together with the declaration of conformity to the essential requirements. Where it concerns radio equipment, such information shall be sufficient to identify on the packaging and the instructions for use of the apparatus the Member States or the geographical area within a Member State where the equipment is intended to be used and shall alert the user by the marking on the apparatus referred to in Annex VII, paragraph 5, to potential restrictions or requirements for authorisation of use of the radio equipment in certain Member States. Where it concerns telecommunications terminal equipment, such information shall be sufficient to identify interfaces of the public telecommunications networks to which the equipment is intended to be connected. For all apparatus such information shall be prominently displayed.
4. In the case of radio equipment using frequency bands whose use is not harmonised throughout the Community, the manufacturer or his authorised representative established within the Community or the person responsible for placing the equipment on the market shall notify the national authority responsible in the relevant Member State for spectrum management of the intention to place such equipment on its national market.
This notification shall be given no less than four weeks in advance of the start of placing on the market and shall provide information about the radio characteristics of the equipment (in particular frequency bands, channel spacing, type of modulation and RF-power) and the identification number of the notified body referred to in Annex IV or V.
Article 7
Putting into service and right to connect
1. Member States shall allow the putting into service of apparatus for its intended purpose where it complies with the appropriate essential requirements identified in Article 3 and the other relevant provisions of this Directive.
2. Not withstanding paragraph 1, and without prejudice to conditions attached to authorisations for the provision of the service concerned in conformity with Community law, Member States may restrict the putting into service of radio equipment only for reasons related to the effective and appropriate use of the radio spectrum, avoidance of harmful interference or matters relating to public health.
3. Without prejudice to paragraph 4, Member States shall ensure that operators of public telecommunications networks do not refuse to connect telecommunications terminal equipment to appropriate interfaces on technical grounds where that equipment complies with the applicable requirements of Article 3.
4. Where a Member State considers that apparatus declared to be compliant with the provisions of this Directive causes serious damage to a network or harmful radio interference or harm to the network or its functioning, the operator may be authorized to refuse connection, to disconnect such apparatus or to withdraw it from service. The Member States shall notify each such authorisation to the Commission, which shall convene a meeting of the committee for the purpose of giving its opinion on the matter. After the committee has been consulted, the Commission may initiate the procedures referred to in Article 5(2) and (3). The Commission and the Member States may also take other appropriate measures.
5. In case of emergency, an operator may disconnect apparatus if the protection of the network requires the equipment to be disconnected without delay and if the user can be offered, without delay and without costs for him, an alternative solution. The operator shall immediately inform the national authority responsible for the implementation of paragraph 4 and Article 9.
Article 8
Free movement of apparatus
1. Member States shall not prohibit, restrict or impede the placing on the market and putting into service in their territory of apparatus bearing the CE marking referred to in Annex VII, which indicates its conformity with all provisions of this Directive, including the conformity assessment procedures set out in Chapter II. This shall be without prejudice to Articles 6(4), 7(2) and 9(5).
2. At trade fairs, exhibitions, demonstrations, etc., Member States shall not create any obstacles to the display of apparatus which does not comply with this Directive, provided that a visible sign clearly indicates that such apparatus may not be marketed or put into service until it has been made to comply.
3. Where the apparatus is subject to other directives which concern other aspects and also provide for the affixing of the CE marking, the latter shall indicate that such apparatus also fulfils the provisions of those other directives. However, should one or more of those directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the apparatus fulfils the provisions only of those directives applied by the manufacturer. In this case, the particulars of those directives, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by those directives and accompanying such products.
Article 9
Safeguards
1. Where a Member State ascertains that apparatus within the scope of this Directive does not comply with the requirements of this Directive, it shall take all appropriate measures in its territory to withdraw the apparatus from the market or from service, prohibit its placing on the market or putting into service or restrict its free movement.
2. The Member State concerned shall immediately notify the Commission of any such measures indicating the reasons for its decision and whether non-compliance is due to:
(a) incorrect application of the harmonised standards referred to in Article 5(1);
(b) shortcomings in the harmonised standards referred to in Article 5(1);
(c) failure to satisfy the requirements referred to in Article 3 where the apparatus does not meet the harmonised standards referred to in Article 5(1).
3. If the measures referred to in paragraph 1 are attributed to incorrect application of the harmonised standards referred to in Article 5(1) or to a failure to satisfy the requirements referred to in Article 3 where the apparatus does not meet the harmonised standards referred to in Article 5(1), the Commission shall consult the parties concerned as soon as possible. The Commission shall forthwith inform the Member States of its findings and of its opinion as to whether the measures are justified, within two months of notification of the said measures to the Commission.
4. Where the decision referred to in paragraph 1 is attributed to shortcomings in the harmonised standards referred to in Article 5(1), the Commission shall bring the matter before the committee within two months. The committee shall deliver an opinion in accordance with the procedure laid down in Article 14. After such consultation, the Commission shall inform the Member States of its findings and of its opinion as to whether the action by the Member State is justified. If it finds that the action is justified it shall forthwith initiate the procedure referred to in Article 5(2).
5. (a) Notwithstanding the provisions of Article 6, a Member State may, acting in conformity with the Treaty, and in particular Articles 30 and 36 thereof, adopt any appropriate measures with a view to:
(i) prohibiting or restricting the placing on its market, and/or
(ii) requiring the withdrawal from its market,
of radio equipment, including types of radio equipment, which has caused or which it reasonably considers will cause harmful interference, including interference with existing or planned services on nationally allocated frequency bands.
(b) Where a Member State takes measures in accordance with subparagraph (a) it shall immediately inform the Commission of the said measures, specifying the reasons for adopting them.
6. When a Member State notifies the Commission of a measure referred to in paragraph 1 or 5 the Commission shall in turn inform other Member States and consult the committee on the matter.
Where, after such consultation, the Commission considers that:
- the measure is justified, it shall immediately so inform the Member State which took the initiative and the other Member States,
- the measure is unjustified, it shall immediately so inform the Member State and request it to withdraw the measure.
7. The Commission shall maintain a record of the cases notified by Member States, which shall be made available to them on request.
CHAPTER II
CONFORMITY ASSESSMENT
Article 10
Conformity assessment procedures
1. The conformity assessment procedures identified in this Article shall be used to demonstrate the compliance of the apparatus with all the relevant essential requirements identified in Article 3.
2. At the choice of the manufacturer, compliance of the apparatus with the essential requirements identified in Article 3(1)(a) and (b) may be demonstrated using the procedures specified in Directive 73/23/EEC and Directive 89/336/EEC respectively, where the apparatus is within the scope of those Directives, as an alternative to the procedures laid out below.
3. Telecommunications terminal equipment which does not make use of the spectrum allocated to terrestrial/space radio communication and receiving parts of radio equipment shall be subject to the procedures described in any one of Annexes II, IV or V at the choice of the manufacturer.
4. Where a manufacturer has applied the harmonised standards referred to in Article 5(1), radio equipment not within the scope of paragraph 3 shall be subject to the procedures described in any one of Annexes III, IV or V at the choice of the manufacturer.
5. Where a manufacturer has not applied or has only applied in part the harmonised standards referred to in Article 5(1), radio equipment not within the scope of paragraph 3 of this Article shall be subject to the procedures described in either of Annexes IV or V at the choice of the manufacturer.
6. Records and correspondence relating to the conformity assessment procedures referred to in paragraphs 2 to 5 shall be in an official language of the Member State where the procedure will be carried out, or in a language accepted by the notified body involved.
Article 11
Notified bodies and surveillance authorities
1. Member States shall notify the Commission of the bodies which they have designated to carry out the relevant tasks referred to in Article 10. Member States shall apply the criteria laid down in Annex VI in determining the bodies to be designated.
2. Member States shall notify the Commission of the authorities established within their territory which are to carry out the surveillance tasks related to the operation of this Directive.
3. The Commission shall publish a list of the notified bodies, together with their identification numbers and the tasks for which they have been notified, in the Official Journal of the European Communities. The Commission shall also publish a list of surveillance authorities in the Official Journal of the European Communities. Member States shall provide the Commission with all information necessary to keep these lists up to date.
CHAPTER III
CE CONFORMITY MARKING AND INSCRIPTIONS
Article 12
CE marking
1. Apparatus complying with all relevant essential requirements shall bear the EC conformity marking referred to in Annex VII. It shall be affixed under the responsibility of the manufacturer, his authorized representative within the Community or the person responsible for placing the apparatus on the market.
Where the procedures identified in Annex III, IV or V are used, the marking shall be accompanied by the identification number of the notified body referred to in Article 11(1). Radio equipment shall in addition be accompanied by the equipment class identifier where such indentifier has been assigned. Any other marking may be affixed to the equipment provided that the visibility and legibility of the EC marking is not thereby reduced.
2. No apparatus, whether or not it complies with the relevant essential requirements, may bear any other marking which is likely to deceive third parties as to the meaning and form of the EC marking specified in Annex VII.
3. The competent Member State shall take appropriate action against any person who has affixed a marking not in conformity with paragraphs 1 and 2. If the person who affixed the marking is not identifiable, appropriate action may be taken against the holder of the apparatus at the time when non-compliance was discovered.
4. Apparatus shall be identified by the manufacturer by means of type, batch and/or serial numbers and by the name of the manufacturer or the person responsible for placing the apparatus on the market.
CHAPTER IV
THE COMMITTEE
Article 13
Constitution of the committee
The Commission shall be assisted by a committee, the Telecommunication Conformity Assessment and Market Surveillance Committee (TCAM), composed of representatives of the Member States and chaired by a representative of the Commission.
Article 14
Advisory committee procedure
1. The committee shall be consulted on the matters covered by Articles 5, 6(2), 7(4), 9(4) and Annex VII(5).
2. The Commission shall consult the committee periodically on the surveillance tasks related to the application of this Directive, and, where appropriate, issue guidelines on this matter.
3. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.
The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.
The Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into account and decide within one month after having received the opinion of the committee.
4. The Commission shall periodically consult the representatives of the telecommunications networks providers, the consumers and the manufacturers. It shall keep the committee regularly informed of the outcome of such consultations.
Article 15
Regulatory committee procedure
1. Notwithstanding the provisions of Article 14, the following procedure shall apply in respect of the matters covered by Articles 3(3) and 4(1).
2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.
If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.
CHAPTER V
FINAL AND TRANSITIONAL PROVISIONS
Article 16
Third countries
1. Member States may inform the Commission of any general difficulties encountered, de jure or de facto, by Community undertakings with respect to placing on the market in third countries, which have been brought to their attention.
2. Whenever the Commission is informed of such difficulties, it may, if necessary, submit proposals to the Council for an appropriate mandate for negotiation of comparable rights for Community undertakings in these third countries. The Council shall decide by qualified majority.
3. Measures taken pursuant to paragraph 2 shall be without prejudice to the obligations of the Community and of the Member States under relevant international agreements.
Article 17
Review and reporting
The Commission shall review the operation of this Directive and report thereon to the European Parliament and to the Council, on the first occasion not later than 7 October 2000 18 months after the entry into force of this Directive and every third year thereafter. The report shall cover progress on drawing up the relevant standards, as well as any problems that have arisen in the course of implementation. The report shall also outline the activities of the committee, assess progress in achieving an open competitive market for apparatus at Community level and examine how the regulatory framework for the placing on the market and putting into service of apparatus should be developed to:
(a) ensure that a coherent system is achieved at Community level for all apparatus;
(b) allow for convergence of the telecommunications, audiovisual and information technology sectors;
(c) enable harmonisation of regulatory measures at international level.
It shall in particular examine whether essential requirements are still necessary for all categories of apparatus covered and whether the procedures contained in Annex IV, third paragraph, are proportionate to the aim of ensuring that the essential requirements are met for apparatus covered by that Annex. Where necessary, further measures may be proposed in the report for full implementation of the aim of the Directive.
Article 18
Transitional provisions
1. Standards under Directive 73/23/EEC or 89/336/EEC whose references have been published in the Official Journal of the European Communities may be used as the basis for a presumption of conformity with the essential requirements referred to in Article 3(1)(a) and Article 3(1)(b). Common technical regulations under Directive 98/13/EC whose references have been published in the Official Journal of the European Communities may be used as the basis for a presumption of conformity with the other relevant essential requirements referred to in Article 3. The Commission shall publish a list of references to those standards in the Official Journal of the European Communities immediately after this Directive enters into force.
2. Member States shall not impede the placing on the market and putting into service of apparatus which is in accordance with the provisions in Directive 98/13/EC or rules in force in their territory and was placed on the market for the first time before this Directive entered into force or at the latest two years after this Directive entered into force.
3. Apart from the essential requirements referred to in Article 3(1), the Member States may request to continue, for a period of up to 30 months following the date referred to in the first sentence of Article 19(1), and in conformity with the provisions of the Treaty, to require telecommunications terminal equipment not to be capable of causing unacceptable deterioration of a voice telephony service accessible within the framework of the universal service as defined in Directive 98/10/EC.
The Member State shall inform the Commission of the reasons for requesting a continuation of such a requirement, the date by which the service concerned will no longer need the requirement, and the measures envisaged in order to meet this deadline. The Commission shall consider the request taking into account the particular situation in the Member State and the need to ensure a coherent regulatory environment at Community level, and shall inform the Member State whether it deems that the particular situation in that Member State justifies a continuation and, if so, until which date such continuation is justified.
Article 19
Transposition
1. Member States shall not later than 7 April 2000 adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. They shall apply these provisions as from 8 April 2000.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by Member States.
2. Member States shall inform the Commission of the main provisions of domestic law which they adopt in the field covered by this Directive.
Article 20
Repeal
1. Directive 98/13/EC is hereby repealed as from 8 April 2000.
2. This Directive is not a specific directive within the meaning of Article 2(2) of Directive 89/336/EEC. The provisions of Directive 89/336/EEC shall not apply to apparatus falling within the scope of this Directive, with the exception of the protection requirements in Article 4 and Annex III and the conformity assessment procedure in Article 10(1) and (2) of, and Annex I to, Directive 89/336/EEC, as from 8 April 2000.
3. The provisions of Directive 73/23/EEC shall not apply to apparatus falling within the scope of this Directive, with the exceptions of the objectives with respect to safety requirements in Article 2 and Annex I and the conformity assessment procedure in Annex III, Section B, and Annex IV to Directive 73/23/EEC, as from 8 April 2000.
Article 21
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 22
Addressees
This Directive is addressed to the Member States.
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[
"UKSI20000730"
] |
31999L0013
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1999
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Council Directive 1999/13/EC of 11 March 1999 on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain activities and installations
Having regard to the Treaty establishing the European Community, and in particular Article 130s(1) thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the Economic and Social Committee (2),
Acting in accordance with the procedure laid down in Article 189c of the Treaty (3),
(1) Whereas the European Community action programme on the environment approved by the Council and the representatives of the Governments of the Member States meeting within the Council by resolutions of 22 November 1973 (4), 17 May 1977 (5), 7 February 1983 (6), 19 October 1987 (7) and 1 February 1993 (8) stresses the importance of the prevention and reduction of air pollution;
(2) Whereas in particular the resolution of 19 October 1987 emphasises the importance of Community action to concentrate, inter alia, on implementation of appropriate standards in order to ensure a high level of public health and environmental protection;
(3) Whereas the European Community and its Member States are parties to the Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution concerning the control of emissions of volatile organic compounds in order to reduce their transboundary fluxes and the fluxes of the resulting secondary photochemical oxidant products so as to protect human health and the environment from adverse effects;
(4) Whereas pollution due to volatile organic compounds in one Member State often influences the air and water of other Member States; whereas, in accordance with Article 130r of the Treaty, action at Community level is necessary;
(5) Whereas, because of their characteristics, the use of organic solvents in certain activities and installations gives rise to emissions of organic compounds into the air which can be harmful for public health and/or contributes to the local and transboundary formation of photochemical oxidants in the boundary layer of the troposphere which cause damage to natural resources of vital environmental and economic importance and, under certain exposure conditions, has harmful effects on human health;
(6) Whereas the high incidence of high tropospheric ozone concentrations in recent years has triggered widespread concern regarding the impact on public health and the environment;
(7) Whereas, therefore, preventive action is required to protect public health and the environment against the consequences of particularly harmful emissions from the use of organic solvents and to guarantee citizens the right to a clean and healthy environment;
(8) Whereas emissions of organic compounds can be avoided or reduced in many activities and installations because potentially less harmful substitutes are available or will become available within the coming years; whereas, where appropriate substitutes are not available, other technical measures should be taken to reduce emissions into the environment as much as economically and technically feasible;
(9) Whereas the use of organic solvents and the emissions of organic compounds which have the most serious effects on public health should be reduced as much as technically feasible;
(10) Whereas installations and processes which fall under this Directive should at least be registered if they are not subject to authorisation under Community or national legislation;
(11) Whereas existing installations and activities should, where appropriate, be adapted so that within an appropriate period they meet the requirements established for new installations and activities; whereas that period should be consistent with the timetable for compliance of Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control (9);
(12) Whereas the relevant parts of existing installations which undergo substantial change must, as a matter of principle, meet the new installation standards for the substantially changed equipment;
(13) Whereas organic solvents are used by many different types of installations and activities so that, in addition to general requirements, specific requirements should be defined and, at the same time, thresholds for the size of the installations or activities which have to comply with this Directive;
(14) Whereas a high level of environmental protection requires the setting and achievement of emission limits for organic compounds and appropriate operating conditions, in accordance with the principle of best available techniques, for certain installations and activities using organic solvents within the Community;
(15) Whereas in some cases Member States may exempt operators from complying with the emission limit values because other measures, such as the use of low-solvent or solvent-free products or techniques, provide alternative means of achieving equivalent emission reductions;
(16) Whereas emission-limiting measures adopted before the entry into force of this Directive should be taken into account in an appropriate way;
(17) Whereas alternative approaches to reduction may allow the objectives of this Directive to be achieved more effectively than by implementing uniform emission limit values; whereas, therefore, Member States may exempt existing installations from compliance with the emission limits if they implement a national plan, which will, within the timetable for implementation of this Directive, lead to an at least equal reduction in emissions of organic compounds from these activities and installations;
(18) Whereas existing installations falling under Directive 96/61/EC which are covered by a national plan can under no circumstances be exempted from the provisions of that Directive, including Article 9(4) thereof;
(19) Whereas in many cases small and medium-sized, new and existing installations may be allowed to comply with somewhat less stringent requirements to maintain their competitiveness;
(20) Whereas for dry cleaning a zero threshold is appropriate, subject to specified exemptions;
(21) Whereas monitoring of emissions is required, including the application of measurement techniques, to assess the mass concentrations or the quantity of the pollutants whose release into the environment is permitted;
(22) Whereas operators should reduce emissions of organic solvents, including fugitive emissions, and of organic compounds; whereas a solvent management plan is an important tool to verify this; whereas, although guidance may be given, the solvent management plan is not developed to the stage where a Community methodology can be established;
(23) Whereas Member States have to establish a procedure to be followed and measures to be taken where emission limitations are exceeded;
(24) Whereas the Commission and the Member States should collaborate in order to ensure that information on the implementation of this Directive and on the progress of substitution options is exchanged,
Article 1 Purpose and scope
The purpose of this Directive is to prevent or reduce the direct and indirect effects of emissions of volatile organic compounds into the environment, mainly into air, and the potential risks to human health, by providing measures and procedures to be implemented for the activities defined in Annex I, in so far as they are operated above the solvent consumption thresholds listed in Annex IIA.
Article 2 Definitions
For the purposes of this Directive:
1. installation shall mean a stationary technical unit where one or more activities falling within the scope defined in Article 1 are carried out, and any other directly associated activities which have a technical connection with the activities carried out on that site and which could have an effect on emissions;
2. existing installation shall mean an installation in operation or, in accordance with legislation existing before the date on which this Directive is brought into effect, an installation which is authorised or registered or, in the view of the competent authority, the subject of a full request for authorisation, provided that the installation is put into operation no later than one year after the date on which this Directive is brought into effect;
3. small installation shall mean an installation which falls within the lower threshold band of items 1, 3, 4, 5, 8, 10, 13, 16 or 17 of Annex IIA or for the other activities of Annex IIA which have a solvent consumption of less than 10 tonnes/year;
4. substantial change
- for an installation falling within the scope of Directive 96/61/EC, shall have the definition specified in that Directive,
- for a small installation, shall mean a change of the nominal capacity leading to an increase of emissions of volatile organic compounds of more than 25 %. Any change that may have, in the opinion of the competent authority, significant negative effects on human health or the environment is also a substantial change,
- for all other installations, shall mean a change of the nominal capacity leading to an increase of emissions of volatile organic compounds of more than 10 %. Any change that may have, in the opinion of the competent authority, significant negative effects on human health or the environment is also a substantial change;
5. competent authority shall mean the authority or authorities or bodies responsible under the legal provisions of the Member States for carrying out the obligations arising from this Directive;
6. operator shall mean any natural or legal person who operates or controls the installation or, where this is provided for in national legislation, to whom decisive economic power over the technical functioning of the installation has been delegated;
7. authorisation shall mean a written decision by which the competent authority grants permission to operate all or part of an installation;
8. registration shall mean a procedure, specified in a legal act, involving at least notification to the competent authority by the operator of the intention to operate an installation or activity falling within the scope of this Directive;
9. emission shall mean any discharge of volatile organic compounds from an installation into the environment;
10. fugitive emissions shall mean any emissions not in waste gases of volatile organic compounds into air, soil and water as well as, unless otherwise stated in Annex IIA, solvents contained in any products. They include uncaptured emissions released to the outside environment via windows, doors, vents and similar openings;
11. waste gases shall mean the final gaseous discharge containing volatile organic compounds or other pollutants, from a stack or abatement equipment into air. The volumetric flow rates shall be expressed in m³/h at standard conditions;
12. total emissions shall mean the sum of fugitive emissions and emissions in waste gases;
13. emission limit value shall mean the mass of volatile organic compounds, expressed in terms of certain specific parameters, concentration, percentage and/or level of an emission, calculated at standard conditions, N, which may not be exceeded during one or more periods of time;
14. substances shall mean any chemical element and its compounds, as they occur in the natural state or as produced by industry, whether in solid or liquid or gaseous form;
15. preparation shall mean mixtures or solutions composed of two or more substances;
16. organic compound shall mean any compound containing at least the element carbon and one or more of hydrogen, halogens, oxygen, sulphur, phosphorus, silicon or nitrogen, with the exception of carbon oxides and inorganic carbonates and bicarbonates;
17. volatile organic compound (VOC) shall mean any organic compound having at 293,15 K a vapour pressure of 0,01 kPa or more, or having a corresponding volatility under the particular conditions of use. For the purpose of this Directive, the fraction of creosote which exceeds this value of vapour pressure at 293,15 K shall be considered as a VOC;
18. organic solvent shall mean any VOC which is used alone or in combination with other agents, and without undergoing a chemical change, to dissolve raw materials, products or waste materials, or is used as a cleaning agent to dissolve contaminants, or as a dissolver, or as a dispersion medium, or as a viscosity adjuster, or as a surface tension adjuster, or a plasticiser, or as a preservative;
19. halogenated organic solvent shall mean an organic solvent which contains at least one atom of bromine, chlorine, fluorine or iodine per molecule;
20. coating shall mean any preparation, including all the organic solvents or preparations containing organic solvents necessary for its proper application, which is used to provide a decorative, protective or other functional effect on a surface;
21. adhesive shall mean any preparation, including all the organic solvents or preparations containing organic solvents necessary for its proper application, which is used to adhere separate parts of a product;
22. ink shall mean a preparation, including all the organic solvents or preparations containing organic solvents necessary for its proper application, which is used in a printing activity to impress text or images on to a surface;
23. varnish shall mean a transparent coating;
24. consumption shall mean the total input of organic solvents into an installation per calendar year, or any other 12-month period, less any VOCs that are recovered for reuse;
25. input shall mean the quantity of organic solvents and their quantity in preparations used when carrying out an activity, including the solvents recycled inside and outside the installation, and which are counted every time they are used to carry out the activity;
26. reuse of organic solvents shall mean the use of organic solvents recovered from an installation for any technical or commercial purpose and including use as a fuel but excluding the final disposal of such recovered organic solvent as waste;
27. mass flow shall mean the quantity of VOCs released, in unit of mass/hour;
28. nominal capacity shall mean the maximum mass input of organic solvents by an installation averaged over one day, if the installation is operated under conditions of normal operation at its design output;
29. normal operation shall mean all periods of operation of an installation or activity except start-up and shut-down operations and maintenance of equipment;
30. contained conditions shall mean conditions under which an installation is operated such that the VOCs released from the activity are collected and discharged in a controlled way either via a stack or abatement equipment and are therefore not entirely fugitive;
31. standard conditions shall mean a temperature of 273,15 K and a pressure of 101,3 kPa;
32. average over 24 hours shall mean the arithmetic average of all valid readings taken during the 24-hour period of normal operation;
33. start-up and shut-down operations shall mean operations whilst bringing an activity, an equipment item or a tank into or out of service or into or out of an idling state. Regularly oscillating activity phases are not to be considered as start-ups and shut-downs.
Article 3 Obligations applying to new installations
Member States shall adopt the necessary measures to ensure that:
1. all new installations comply with Articles 5, 8 and 9;
2. all new installations not covered by Directive 96/61/EC are registered or undergo authorisation before being put into operation.
Article 4 Obligations applying to existing installations
Without prejudice to Directive 96/61/EC, Member States shall adopt the necessary measures to ensure that:
1. existing installations comply with Articles 5, 8 and 9 no later than 31 October 2007;
2. all existing installations must have been registered or authorised by 31 October 2007 at the latest;
3. those installations to be authorised or registered using the reduction scheme of Annex IIB notify this to the competent authorities by 31 October 2005 at the latest;
4. where an installation:
- undergoes a substantial change, or
- comes within the scope of this Directive for the first time following a substantial change,
that part of the installation which undergoes the substantial change shall be treated either as a new installation or as an existing installation, provided that the total emissions of the whole installation do not exceed those that would have resulted had the substantially changed part been treated as a new installation.
Article 5 Requirements
1. Member States shall take the appropriate measures, either by specification in the conditions of the authorisation or by general binding rules to ensure that paragraphs 2 to 12 are complied with.
2. All installations shall comply with:
(a) either the emission limit values in waste gases and the fugitive emission values, or the total emission limit values, and other requirements laid down in Annex IIA;
or
(b) the requirements of the reduction scheme specified in Annex IIB.
3. (a) For fugitive emissions, Member States shall apply fugitive emission values to installations as an emission limit value. However, where it is demonstrated to the satisfaction of the competent authority that for an individual installation this value is not technically and economically feasible, the competent authority can make an exception for such an individual installation provided that significant risks to human health or the environment are not to be expected. For each derogation, the operator must demonstrate to the satisfaction of the competent authority that the best available technique is being used;
(b) activities which cannot be operated under contained conditions may be exempted from the controls of Annex IIA, when this possibility is explicitly mentioned in that Annex. The reduction scheme of Annex IIB is then to be used, unless it is demonstrated to the satisfaction of the competent authority that this option is not technically and economically feasible. In this case, the operator must demonstrate to the satisfaction of the competent authority that the best available technique is being used.
Member States shall report to the Commission on the derogation concerning paragraphs (a) and (b) in accordance with Article 11.
4. For installations not using the reduction scheme, any abatement equipment installed after the date on which this Directive is brought into effect shall meet all the requirements of Annex IIA.
5. Installations where two or more activities are carried out, each of which exceeds the thresholds in Annex IIA shall:
(a) as regards the substances specified in paragraphs 6, 7 and 8, meet the requirements of those paragraphs for each activity individually;
(b) as regards all other substances, either:
(i) meet the requirements of paragraph 2 for each activity individually; or
(ii) have total emissions not exceeding those that would have resulted had point (i) been applied.
6. Substances or preparations which, because of their content of VOCs classified as carcinogens, mutagens, or toxic to reproduction under Directive 67/548/EEC (10), are assigned or need to carry the risk phrases R45, R46, R49, R60, R61, shall be replaced, as far as possible and by taking into account the guidance as mentioned in Article 7(1), by less harmful substances or preparations within the shortest possible time.
7. For discharges of the VOCs referred to in paragraph 6, where the mass flow of the sum of the compounds causing the labelling referred to in that paragraph is greater than, or equal to, 10 g/h, an emission limit value of 2 mg/Nm³ shall be complied with. The emission limit value refers to the mass sum of the individual compounds.
8. For discharges of halogenated VOCs which are assigned the risk phrase R40, where the mass flow of the sum of the compounds causing the labelling R40 is greater than, or equal to, 100 g/h, an emission limit value of 20 mg/Nm³ shall be complied with. The emission limit value refers to the mass sum of the individual compounds.
The discharge of VOCs referred to in paragraphs 6 and 8 shall be controlled as emissions from an installation under contained conditions as far as technically and economically feasible to safeguard public health and the environment.
9. Discharges of those VOCs which, after the entry into force of this Directive, are assigned or need to carry one of the risk phrases mentioned in paragraphs 6 and 8, shall have to comply with the emission limit values mentioned in paragraphs 7 and 8 respectively, within the shortest possible time.
10. All appropriate precautions shall be taken to minimise emissions during start-up and shut-down.
11. Existing installations which operate existing abatement equipment and comply with the following emission limit values:
- 50 mg C/Nm³ in the case of incineration,
- 150 mg C/Nm³ in the case of any other abatement equipment,
shall be exempt from the waste gases emission limit values in the table in Annex IIA for a period of 12 years after the date referred to in Article 15, provided the total emissions of the whole installation do not exceed those that would have resulted had all the requirements of the table been met.
12. Neither the reduction scheme nor the application of paragraph 11 nor Article 6 exempt installations discharging substances specified in paragraphs 6, 7 and 8 from fulfilling the requirements of those paragraphs.
13. Where a risk assessment is carried out in accordance with Council Regulation (EEC) No 793/93 (11) and Commission Regulation (EC) No 1488/94 (12) or Council Directive 67/548/EEC and Commission Directive 93/67/EEC (13) of any of the substances causing the labelling R40, R60 or R61 which are controlled under this Directive, the Commission shall consider the conclusions of the risk assessment and shall take the necessary measures as appropriate.
Article 6 National plans
1. Without prejudice to Directive 96/61/EC, Member States may define and implement national plans for reducing emissions from the activities and industrial installations covered by Article 1, excluding activities 4 and 11 of Annex IIA. None of the other activities may be excluded from the scope of this Directive by means of a national plan. These plans shall result in a reduction of the annual emissions of VOCs from existing installations covered by this Directive by at least the same amount and within the same time frame as would have been achieved by applying the emission limits under Article 5(2) and (3) and Annex II, during the validity period of the national plan. The national plan, if necessary updated, will be resubmitted to the Commission every three years.
A Member State which defines and implements national plans may exempt existing installations from implementation of the emission limit values laid down in Article 5(2) and (3) and Annex II. A national plan may under no circumstances exempt an existing installation from the provisions laid down in Directive 96/61/EC.
2. A national plan shall include a list of the measures taken or to be taken to ensure that the aim specified in paragraph 1 will be achieved, including details of the proposed plan monitoring mechanism. It shall also include binding interim reduction targets against which progress towards the aim can be measured. It shall be compatible with the relevant existing Community legislation, including the relevant provisions of this Directive, and shall include:
- an identification of the activity or activities to which the plan applies,
- the reduction in emissions to be achieved by those activities which corresponds to that which would have been achieved by applying the emission limits as specified in paragraph 1,
- the number of installations affected by the plan and their total emissions and the total emission of each of the activities.
The plan shall also include a full description of the range of instruments through which its requirements will be achieved, evidence that these instruments will be enforceable and details of the means by which compliance with the plan will be demonstrated.
3. The Member State shall submit the plan to the Commission. The plan must be accompanied by supporting documentation sufficient to verify that the aim of paragraph 1 will be achieved, including any documentation specifically requested by the Commission. Existing installations undergoing a substantial change shall remain within the scope of the national plan, provided that they were part of this plan before undergoing such substantial change.
4. The Member State shall designate a national authority for the collection and evaluation of the information required by paragraph 3 and for the implementation of the national plan.
5. (a) The Commission shall inform the committee referred to in Article 13 of the criteria for assessing national plans, one year after the entry into force of this Directive at the latest.
(b) If the Commission, in considering the plan, the resubmitted plan, or in considering the progress reports submitted by the Member State under Article 11, is not satisfied that the objectives of the plan will be achieved within the prescribed period, it shall inform the Member State and the committee referred to in Article 13 of its opinion and of the reasons for reaching such an opinion. It shall do so within six months of receipt of the plan or report. The Member State shall then notify the Commission and inform the committee, within three months, of the corrective measures it will take in order to ensure that the objectives are achieved.
6. If the Commission decides within six months of the notification of the corrective measures that those measures are insufficient to ensure that the objective of the plan is achieved within the prescribed period, the Member State shall be obliged to satisfy the requirements of Article 5(2) and (3) and Annex II within the period specified in this Directive in the case of existing installations. The Commission shall inform the committee referred to in Article 13 of its decision.
Article 7 Substitution
1. The Commission shall ensure that an exchange of information between Member States and the activities concerned on the use of organic substances and their potential substitutes takes place. It shall consider the questions of:
- fitness for use,
- potential effects on human health and occupational exposure in particular;
- potential effects on the environment, and
- the economic consequences, in particular, the costs and benefits of the options available,
with a view to providing guidance on the use of substances and techniques which have the least potential effects on air, water, soil, ecosystems and human health. Following the exchange of information, the Commission shall publish guidance for each activity.
2. Member States shall ensure that the guidance referred to in paragraph 1 is taken into account during authorisation and during the formulation of general binding rules.
Article 8 Monitoring
1. Member States shall introduce an obligation for the operator of an installation covered by this Directive to supply the competent authority once a year or on request with data that enables the competent authority to verify compliance with this Directive.
2. Member States shall ensure that channels to which abatement equipment is connected, and which at the final point of discharge emit more than an average of 10 kg/h of total organic carbon, are monitored continuously for compliance.
3. In the other cases, Member States shall ensure that either continuous or periodic measurements are carried out. For periodic measurements at least three readings shall be obtained during each measurement exercise.
4. Measurements are not required in the case where end-of-pipe abatement equipment is not needed to comply with this Directive.
5. The Commission shall organise an exchange of information on the use of solvent management plans in Member States based on the data for the implementation of this Directive in the three years following the date referred to in Article 15.
Article 9 Compliance with emission limit values
1. Compliance with the following shall be demonstrated to the satisfaction of the competent authority:
- emission limit values in waste gases, fugitive emission values and total emission limit values,
- the requirements of the reduction scheme under Annex IIB,
- the provisions of Article 5(3).
Guidance is provided in Annex III on solvent management plans serving to demonstrate compliance with these parameters.
Gas volumes may be added to the waste gas for cooling or dilution purposes where technically justified but shall not be considered when determining the mass concentration of the pollutant in the waste gas.
2. Following a substantial change, compliance shall be reverified.
3. In the case of continuous measurements the emission limit values shall be considered to be complied with if:
(a) none of the averages over 24 hours of normal operation exceeds the emission limit values, and
(b) none of the hourly averages exceeds the emission limit values by more than a factor of 1,5.
4. In the case of periodic measurements the emission limit values shall be considered to be complied with if, in one monitoring exercise:
(a) the average of all the readings does not exceed the emission limit values, and
(b) none of the hourly averages exceeds the emission limit value by more than a factor of 1,5.
5. Compliance with the provisions of Article 5(7) and (8) shall be verified on the basis of the sum of the mass concentrations of the individual volatile organic compounds concerned. For all other cases, compliance shall be verified on the basis of the total mass of organic carbon emitted unless otherwise specified in Annex IIA.
Article 10 Non-compliance
Member States shall take appropriate measures to ensure that, if it is found that the requirements of this Directive have been breached:
(a) the operator informs the competent authority and takes measures to ensure that compliance is restored within the shortest possible time;
(b) in cases of non-compliance causing immediate danger to human health and as long as compliance is not restored under the conditions of paragraph (a), operation of the activity is suspended.
Article 11 Information systems and reporting
1. At intervals of three years, Member States shall send information to the Commission on the implementation of this Directive in the form of a report. The report shall be drawn up on the basis of a questionnaire or outline drafted by the Commission in accordance with the procedure laid down in Article 6 of Directive 91/692/EEC (14). The questionnaire or outline shall be sent to the Member States six months before the start of the period covered by the report. The report shall be made to the Commission within nine months of the end of the three-year period covered by it. Member States shall publish the reports produced at the same time as they are transmitted to the Commission, subject to the restrictions laid down in Article 3(2) and (3) of Directive 90/313/EEC (15). The first report shall cover the period of the first three years after the date referred to in Article 15.
2. The information submitted under paragraph 1 shall, in particular, include sufficient representative data to demonstrate that the requirements of Article 5 and as the case may be, the requirements of Article 6 have been complied with.
3. The Commission shall draw up a report on the implementation of this Directive on the basis of the data provided by the Member States at the latest five years after the first reports are submitted by the Member States. The Commission shall submit this report to the European Parliament and the Council, accompanied by proposals if necessary.
Article 12 Public access to information
1. Without prejudice to Directive 90/313/EEC, Member States shall take the necessary measures to ensure that at least applications for authorisation for new installations or for substantial changes of those installations requiring a permit under Directive 96/61/EC are made available for an appropriate period of time to the public, to enable it to comment on them before the competent authority reaches a decision. Without prejudice to Directive 96/61/EC, no obligation to reformat the information for the public is implied.
The decision of the competent authority, including at least a copy of the authorisation, and any subsequent updates, must also be made available to the public.
The general binding rules applicable for installations and the list of registered and authorised activities shall be made available to the public.
2. The results of emission-monitoring as required under the authorisation or registration conditions referred to in Articles 8 and 9 and held by the competent authority must be made available to the public.
3. Paragraphs 1 and 2 shall apply, subject to the restrictions regarding grounds for refusal by public authorities to provide information, including commercial and industrial confidentiality, laid down in Article 3(2) and (3) of Directive 90/313/EEC.
Article 13 Committee
The Commission shall be assisted by a committee of an advisory nature composed of the representatives of the Member States and chaired by the representative of the Commission.
The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft, within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.
The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.
The Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into account.
Article 14 Sanctions
Member States shall determine the sanctions applicable to breaches of the national provisions adopted pursuant to this Directive and shall take all necessary measures for their implementation. The sanctions determined must be effective, proportionate and dissuasive. Member States shall notify these provisions to the Commission at the latest by the date mentioned in Article 15, and shall notify any subsequent modification of them as soon as possible.
Article 15 Transposition
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than . . . April 2001. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 16 Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 17 Addressees
This Directive is addressed to the Member States.
|
[
"UKSI20001973",
"UKSI20040107",
"UKPGA19990024"
] |
31999L0016
|
1999
|
Commission Directive 1999/16/EC of 16 March 1999 adapting to technical progress Council Directive 77/540/EEC relating to parking lamps for motor vehicles Text with EEA relevance.
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers(1), as last amended by Directive 98/91/EC of the European Parliament and of the Council(2), and in particular Article 13(2) thereof,
Having regard to Council Directive 77/540/EEC of 28 June 1977 on the approximation of the laws of the Member States relating to parking lamps for motor vehicles(3), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 10 thereof,
(1) Whereas Directive 77/540/EEC is one of the separate Directives of the EC type-approval procedure which has been established by Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to Directive 77/540/EEC;
(2) Whereas, in particular, Article 3(4) and Article 4(3) of Directive 70/156/EEC require each separate Directive to have attached to it an information document and also a type-approval certificate based on Annex VI to Directive 70/156/EEC in order that type-approval may be computerised; whereas the type-approval certificate provided for in Directive 77/540/EEC should be amended accordingly;
(3) Whereas the procedures should be simplified in order to maintain the equivalence envisaged by Article 9(2) of Directive 70/156/EEC between certain separate Directives and the corresponding regulations of the United Nations' Economic Commission for Europe (UN-ECE), when those regulations are amended; whereas, as a first step, the technical requirements of Directive 77/540/EEC should be replaced by those of UN-ECE Regulation No 77 by way of cross-reference;
(4) Whereas it is necessary to ensure that the requirements in Council Directive 76/756/EEC(4), as last amended by Commission Directive 97/28/EC(5), and in Council Directive 76/761/EEC(6), as last amended by Commission Directive 1999/17/EC(7), are complied with;
(5) Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC,
Article 1
Directive 77/540/EEC is amended as follows:
1. In Article 1, paragraph 1 is replaced by the following:
"1. Each Member State shall grant EC component type-approval for any type of parking lamp which satisfies the construction and testing requirements laid down in the relevant Annexes."
2. In Article 2, the first paragraph is replaced by the following:
"Member States shall, for each type of parking lamp which they approve pursuant to Article 1, issue to the manufacturer an EC component type-approval mark conforming to the model shown in Annex I, Appendix 3."
3. Article 4 is replaced by the following:
"Article 4
The competent authorities of the Member States shall inform each other, by means of the procedures specified in Article 4(6) of Directive 70/156/EEC, of each approval which they have granted, refused or withdrawn pursuant to this Directive."
4. Article 9 is replaced by the following:
"Article 9
For the purposes of this Directive, 'vehicle' means any motor vehicle intended for use on the road, with or without bodywork, having at least four wheels and a maximum design speed exceeding 25 km/h, and its trailers, with the exception of vehicles which run on rails and of agricultural and forestry tractors and all mobile machinery."
5. The Annexes are replaced by the text in the Annex to this Directive.
Article 2
1. From 1 October 1999, or, if the publication of the texts referred to in Article 3 is delayed beyond 1 April 1999, six months after the actual date of publication of these texts, Member States may not, on grounds relating to parking lamps:
- refuse, in respect of a type of vehicle or a type of parking lamp, to grant EC type-approval or national type-approval, or
- prohibit the registration, sale or entry into service of vehicles, or the sale or entry into service of parking lamps,
provided that the parking lamps comply with the requirements of Directive 77/540/EEC, as amended by this Directive, and that, as far as vehicles are concerned, they are installed in accordance with the requirements laid down in Directive 76/756/EEC.
2. From 1 April 2000 Member States:
- shall no longer grant EC type-approval, and
- may refuse to grant national type-approval
for any type of vehicle on grounds relating to parking lamps, and for any type of parking lamp, if the requirements of Directive 77/540/EEC, as amended by this Directive, are not fulfilled.
3. From 1 April 2001 the requirements of Directive 77/540/EEC relating to parking lamps as components, as amended by this Directive, shall be applicable for the purposes of Article 7(2) of Directive 70/156/EEC.
4. Notwithstanding paragraphs 2 and 3, for the purposes of replacement parts Member States shall continue to grant EC type-approval of parking lamps, and to permit their sale and entry into service, in accordance with previous versions of Directive 77/540/EEC provided that such parking lamps
- are intended to be fitted to vehicles already in use, and
- comply with the requirements of that Directive which were applicable when the vehicles where first registered.
Article 3
The paragraphs and annexes of UN-ECE Regulation No 77, referred to in point 1 of Annex II, shall be published in the Official Journal of the European Communities before 1 April 1999.
Article 4
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 October 1999; however, if the publication of the texts referred to in Article 3 is delayed beyond 1 April 1999, the Member States shall comply with this obligation six months after the actual date of publication of these texts. They shall forthwith inform the Commission thereof.
They shall apply those provisions from 1 October 1999, or, if the publication of the texts referred to in Article 3 is delayed beyond 1 April 1999, six months after the actual date of publication of those texts.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.
Article 5
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 6
This Directive is addressed to the Member States.
|
[
"UKSI19992324"
] |
31999L0015
|
1999
|
Commission Directive 1999/15/EC of 16 March 1999 adapting to technical progress Council Directive 76/759/EEC relating to direction indicator lamps for motor vehicles and their trailers Text with EEA relevance.
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers(1), as last amended by Directive 98/91/EC of the European Parliament and of the Council(2), and in particular Article 13(2) thereof,
Having regard to Council Directive 76/759/EEC of 27 June 1976 on the approximation of the laws of the Member States relating to direction indicator lamps for motor vehicles and their trailers(3), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 10 thereof,
(1) Whereas Directive 76/759/EEC is one of the separate Directives of the EC type-approval procedure which has been established by Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to Directive 76/759/EEC;
(2) Whereas, in particular, Article 3(4) and Article 4(3) of Directive 70/156/EEC require each separate Directive to have attached to it an information document and also a type-approval certificate based on Annex VI to Directive 70/156/EEC in order that type-approval may be computerised; whereas the type-approval certificate provided for in Directive 76/759/EEC should be amended accordingly;
(3) Whereas the procedures should be simplified in order to maintain the equivalence envisaged by Article 9(2) of Directive 70/156/EEC between certain separate Directives and the corresponding regulations of the United Nations' Economic Commission for Europe (UN-ECE), when those regulations are amended; whereas, as a first step, the technical requirements of Directive 76/759/EEC should be replaced by those of UN-ECE Regulation No 6 by way of cross-reference;
(4) Whereas it is necessary to ensure that the requirements in Council Directive 76/756/EEC(4), as last amended by Commission Directive 97/28/EC(5), and in Council Directive 76/761/EEC(6), as last amended by Commission Directive 1999/17/EC(7), are complied with;
(5) Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC,
Article 1
Directive 76/759/EEC is amended as follows:
1. In Article 1, paragraph 1 is replaced by the following:
"1. Each Member State shall grant EC component type-approval for any type of direction indicator lamp which satisfies the construction and testing requirements laid down in the relevant Annexes."
2. In Article 2, the first paragraph is replaced by the following:
"Member States shall, for each type of direction indicator lamp which they approve pursuant to Article 1, issue to the manufacturer an EC component type-approval mark conforming to the model shown in Annex I, Appendix 3."
3. Article 4 is replaced by the following:
"Article 4
The competent authorities of the Member States shall inform each other, by means of the procedures specified in Article 4(6) of Directive 70/156/EEC, of each approval which they have granted, refused or withdrawn pursuant to this Directive."
4. Article 9 is replaced by the following:
"Article 9
For the purposes of this Directive, 'vehicle' means any motor vehicle intended for use on the road, with or without bodywork, having at least four wheels and a maximum design speed exceeding 25 km/h, and its trailers, with the exception of vehicles which run on rails and of agricultural and forestry tractors and all mobile machinery."
5. The Annexes are replaced by the text in the Annex to this Directive.
Article 2
1. From 1 October 1999, or, if the publication of the texts referred to in Article 3 is delayed beyond 1 April 1999, six months after the actual date of publication of these texts, Member States may not, on grounds relating to direction indicator lamps:
- refuse, in respect of a type of vehicle or a type of direction indicator lamp, to grant EC type-approval or national type-approval, or
- prohibit the registration, sale or entry into service of vehicles, or the sale or entry into service of direction indicator lamps,
provided that the direction indicator lamps comply with the requirements of Directive 76/759/EEC, as amended by this Directive, and that, as far as vehicles are concerned, they are installed in accordance with the requirements laid down in Directive 76/756/EEC.
2. From 1 April 2000 Member States:
- shall no longer grant EC type-approval, and
- may refuse to grant national type-approval
for any type of vehicle on grounds relating to direction indicator lamps, and for any type of direction indicator lamp, if the requirements of Directive 76/759/EEC, as amended by this Directive, are not fulfilled.
3. From 1 April 2001 the requirements of Directive 76/759/EEC relating to direction indicator lamps as components, as amended by this Directive, shall be applicable for the purposes of Article 7(2) of Directive 70/156/EEC.
4. Notwithstanding paragraphs 2 and 3, for the purposes of replacement parts Member States shall continue to grant EC type-approval of direction indicator lamps, and to permit their sale and entry into service, in accordance with previous versions of Directive 76/759/EEC provided that such direction indicator lamps:
- are intended to be fitted to vehicles already in use, and
- comply with the requirements of that Directive which were applicable when the vehicles where first registered.
Article 3
The paragraphs and annexes of UN-ECE Regulation No 6, referred to in point 1 of Annex II, shall be published in the Official Journal of the European Communities before 1 April 1999.
Article 4
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 October 1999; however, if the publication of the texts referred to in Article 3 is delayed beyond 1 April 1999, the Member States shall comply with this obligation six months after the actual date of publication of these texts. They shall forthwith inform the Commission thereof.
They shall apply those provisions from 1 October 1999, or, if the publication of the texts referred to in Article 3 is delayed beyond 1 April 1999, six months after the actual date of publication of those texts.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.
Article 5
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 6
This Directive is addressed to the Member States.
|
[
"UKSI19992324"
] |
31999L0018
|
1999
|
Commission Directive 1999/18/EC of 18 March 1999 adapting to technical progress Council Directive 76/762/EEC relating to front fog lamps for motor vehicles and filament lamps for such lamps Text with EEA relevance.
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers(1), as last amended by Directive 98/91/EC of the European Parliament and of the Council(2), and in particular Article 13(2) thereof,
Having regard to Council Directive 76/762/EEC of 27 June 1976 on the approximation of the laws of the Member States relating to front fog lamps for motor vehicles and filament lamps for such lamps(3), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 10 thereof,
(1) Whereas Directive 76/762/EEC is one of the separate Directives of the EC type-approval procedure which has been established by Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to Directive 76/762/EEC;
(2) Whereas, in particular, Article 3(4) and Article 4(3) of Directive 70/156/EEC require each separate Directive to have attached to it an information document and also a type-approval certificate based on Annex VI to Directive 70/156/EEC in order that type-approval may be computerised; whereas the type-approval certificate provided for in Directive 76/762/EEC should be amended accordingly;
(3) Whereas the procedures should be simplified in order to maintain the equivalence envisaged by Article 9(2) of Directive 70/156/EEC between certain separate Directives and the corresponding regulations of the United Nations' Economic Commission for Europe (UN-ECE), when those regulations are amended; whereas, as a first step, the technical requirements of Directive 76/762/EEC should be replaced by those of UN-ECE Regulation No 19 by way of cross-reference;
(4) Whereas it is necessary to ensure that the requirements in Council Directive 76/756/EEC(4), as last amended by Commission Directive 97/28/EC(5), and in Council Directive 76/761/EEC(6), as last amended by Commission Directive 1999/17/EC(7), are complied with;
(5) Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Directive 70/156/EEC,
Article 1
Directive 76/762/EEC is amended as follows:
1. The title is replaced by the following:
"on the approximation of the laws of the Member States relating to front fog lamps for motor vehicles."
2. In Article 1, paragraph 1 is replaced by the following:
"1. Each Member State shall grant EC component type-approval for any type of rear fog lamp which satisfies the construction and testing requirements laid down in the relevant Annexes."
3. In Article 2, the first paragraph is replaced by the following:
"Member States shall, for each type of front fog lamp which they approve pursuant to Article 1, issue to the manufacturer an EC component type-approval mark conforming to the model shown in Annex I, Appendix 3."
4. Article 4 is replaced by the following:
"Article 4
The competent authorities of the Member States shall inform each other, by means of the procedures specified in Article 4 (6) of Directive 70/156/EEC, of each approval which they have granted, refused or withdrawn pursuant to this Directive."
5. Article 9 is replaced by the following:
"Article 9
For the purposes of this Directive, 'vehicle' means any motor vehicle intended for use on the road, with or without bodywork, having at least four wheels and a maximum design speed exceeding 25 km/h, and its trailers, with the exception of vehicles which run on rails and of agricultural and forestry tractors and all mobile machinery."
6. The Annexes are replaced by the text in the Annex to this Directive.
Article 2
1. From 1 October 1999, or, if the publication of the texts referred to in Article 3 is delayed beyond 1 April 1999, six months after the actual date of publication of these texts, Member States may not, on grounds relating to front fog lamps:
- refuse, in respect of a type of vehicle or a type of front fog lamp, to grant EC type-approval or national type-approval, or
- prohibit the registration, sale or entry into service of vehicles, or the sale or entry into service of front fog lamps,
provided that the front fog lamps comply with the requirements of Directive 76/762/EEC, as amended by this Directive, and that, as far as vehicles are concerned, they are installed in accordance with the requirements laid down in Directive 76/756/EEC.
2. From 1 April 2000 Member States:
- shall no longer grant EC type-approval, and
- may refuse to grant national type-approval
for any type of vehicle on grounds relating to front fog lamps, and for any type of front fog lamp, if the requirements of Directive 76/762/EEC, as amended by this Directive, are not fulfilled.
3. From 1 April 2001 the requirements of Directive 76/762/EEC relating to front fog lamps as components, as amended by this Directive, shall be applicable for the purposes of Article 7(2) of Directive 70/156/EEC.
4. Notwithstanding paragraphs 2 and 3, for the purposes of replacement parts Member States shall continue to grant EC type-approval of front fog lamps, and to permit their sale and entry into service, in accordance with previous versions of Directive 76/762/EEC provided that such front fog lamps
- are intended to be fitted to vehicles already in use, and
- comply with the requirements of that Directive which were applicable when the vehicles where first registered.
Article 3
The paragraphs and annexes of UN-ECE Regulation No 19 referred to in point 1 of Annex II, shall be published in the Official Journal of the European Communities before 1 April 1999.
Article 4
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 October 1999; however, if the publication of the texts referred to in Article 3 is delayed beyond 1 April 1999, the Member States shall comply with this obligation six months after the actual date of publication of these texts. They shall forthwith inform the Commission thereof.
They shall apply those provisions from 1 October 1999, or, if the publication of the texts referred to in Article 3 is delayed beyond 1 April 1999, six months after the actual date of publication of those texts.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.
Article 5
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 6
This Directive is addressed to the Member States.
|
[
"UKSI19992324"
] |
31999L0017
|
1999
|
Commission Directive 1999/17/EC of 18 March 1999 adapting to technical progress Council Directive 76/761/EEC relating to motor vehicle headlamps which function as main-beam and/or dipped-beam headlamps and to incandescent electric filament lamps for such headlamps Text with EEA relevance.
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers(1), as last amended by Directive 98/91/EC of the European Parliament and of the Council(2), and in particular Article 13(2) thereof,
Having regard to Council Directive 76/761/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to motor vehicle headlamps which function as main-beam and/or dipped-beam headlamps and to incandescent electric filament lamps for such headlamps(3), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 10 thereof,
(1) Whereas Directive 76/761/EEC is one of the separate Directives of the EC type-approval procedure which has been established by Directive 70/156/EEC; whereas, consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to Directive 76/761/EEC;
(2) Whereas, in particular, Article 3(4) and Article 4(3) of Directive 70/156/EEC require each separate Directive to have attached to it an information document and also a type-approval certificate based on Annex VI to Directive 70/156/EEC in order that type-approval may be computerised; whereas the type-approval certificate(s) provided for in Directive 76/761/EEC should be amended accordingly;
(3) Whereas the procedures should be simplified in order to maintain the equivalence envisaged by Article 9(2) of Directive 70//156/EEC between certain separate Directives and the corresponding regulations of the United Nations' Economic Commission for Europe (UN-ECE) when those regulations are amended; whereas, as a first step, the technical requirements of Directive 76/761/EEC should be replaced by those of UN-ECE Regulations Nos 1, 5, 8, 20, 31, 37, 98 and 99 by way of cross-reference;
(4) Whereas it is necessary to ensure that the requirements in Council Directive 76/756/EEC(4), as last amended by Commission Directive 97/28/EC(5), are complied with;
(5) Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for adaptation to technical progress established by Directive 70/156/EEC,
Article 1
Directive 76/761/EEC is amended as follows:
1. The title is replaced by the following:
"on the approximation of the laws of the Member States relating to motor vehicle headlamps which function as main-beam and/or dipped-beam headlamps and to light sources (filament lamps and others) for use in approved lamp units of motor vehicles and of their trailers."
2. In Article 1, paragraph 1 is replaced by the following:
"1. Each Member State shall grant EC component type-approval for any type of headlamp which functions as a main-beam and/or dipped-beam headlamp and for any type of light source (filament lamp(s) and other(s)) for use in approved lamp units which satisfy the construction and testing requirements laid down in the relevant Annexes."
3. Articles 2, 3 and 4 are replaced by the following:
"Article 2
Member States shall, for each type of headlamp which functions as a main-beam and/or dipped-beam headlamp or for each type of light source (filament lamp(s) and other(s)) for use in approved lamp units which they approve pursuant to Article 1, issue to the manufacturer an EC component type-approval mark conforming to the model shown in Annex I, Appendix 5.
Member States shall take all appropriate measures to prevent the use of marks liable to create confusion between headlamps which function as main-beam and/or dipped-beam headlamps and light source(s) (filament lamp(s) and other(s)) for use in approved lamp units which have been type-approved pursuant to Article 1, and other devices.
Article 3
1. No Member State may prohibit the placing on the market of headlamps which function as main-beam and/or dipped-beam headlamps and light source(s) (filament lamp(s) and other(s)) for use in approved lamp units on grounds relating to their construction or method of functioning, if they bear the EC component type-approval mark.
2. A Member State may prohibit the placing on the market of headlamps which function as main-beam and/or dipped-beam headlamps and light source(s) (filament lamp(s) and other(s)) for use in approved lamp units bearing the EC component type-approval mark which consistently fail to conform to the approved type.
That State shall forthwith inform the other Member States and the Commission of the measures taken, specifying the reasons for its decision.
Article 4
The competent authorities of the Member States shall inform each other, by means of the procedure specified in Article 4(6) of Directive 70/156/EEC, of each approval which they have granted, refused or withdrawn pursuant to this Directive."
4. In Article 5(1), the first sentence is replaced by the following:
"If the Member State which has granted EC component type-approval finds that a number of headlamps which function as main-beam and/or dipped-beam headlamps or light source(s) (filament lamp(s) and other(s)) for use in approved lamp units bearing the same EC component type-approval mark do not conform to the type which it has approved, it shall take the necessary measures to ensure that production models conform to the approved type."
5. In Article 6, the first sentence is replaced by the following:
"Any decision taken pursuant to the provisions adopted in implementation of this Directive to refuse or withdraw EC component type-approval for a main-beam or a dipped-beam headlamp or for a light source(s) (filament lamp(s) and other(s)) for use in approved lamp units or prohibit their placing on the market or use shall set out in detail the reasons on which it is based."
6. Articles 7, 8 and 9 are replaced by the following:
"Article 7
No Member State may refuse to grant EC type-approval or national type-approval of a vehicle on grounds relating to its headlamps which function as main-beam and/or dipped-beam headlamps or to the light source(s) (filament lamp(s) and other(s)) for use in approved lamp units if these bear the EC component type-approval mark and are fitted in accordance with the requirements laid down in Directive 76/756/EEC.
Article 8
No Member State may refuse or prohibit the sale or registration, entry into service or use of a vehicle on grounds relating to its headlamps which function as main-beam and/or dipped-beam headlamps or to the light source(s) (filament lamp(s) and other(s)) for use in approved lamp units if these bear the EC component type-approval mark and are fitted in accordance with the requirements laid down in Directive 76/756/EEC.
Article 9
For the purposes of this Directive, 'vehicle' means any motor vehicle intended for use on the road, with or without bodywork, having at least four wheels and a maximum design speed exceeding 25 km/h, with the exception of vehicles which run on rails and of agricultural and forestry tractors and all mobile machinery."
7. The Annexes are replaced by the text in the Annex to this Directive.
Article 2
1. From 1 October 1999, or, if the publication of the texts referred to in Article 3 is delayed beyond 1 April 1999, six months after the actual date of publication of these texts, Member States may not, on grounds relating to headlamps which function as main-beam and/or dipped-beam headlamps and to light sources (filament lamps and others) for use in approved lamp units, hereinafter referred to as "headlamps" and "light sources", respectively:
- refuse, in respect of a type of vehicle or a type of headlamp or light source, to grant EC type-approval or national type-approval, or
- prohibit the registration, sale or entry into service of vehicles, or the sale or entry into service of headlamps or light sources,
provided that the headlamps or light sources comply with the requirements of Directive 76/761/EEC, as amended by this Directive, and that, as far as vehicles are concerned, they are installed in accordance with the requirements laid down in Directive 76/756/EEC.
2. From 1 April 2000 Member States:
- shall no longer grant EC type-approval, and
- may refuse to grant national type-approval
for any type of vehicle on grounds relating to headlamps or light sources, and for any type of headlamp or light source, if the requirements of Directive 76/761/EEC, as amended by this Directive, are not fulfilled.
3. From 1 April 2001 the requirements of Directive 76/761/EEC relating to headlamps or light sources as components, as amended by this Directive, shall be applicable for the purposes of Article 7(2) of Directive 70/156/EEC.
4. Notwithstanding paragraphs 2 and 3, for the purposes of replacement parts Member States shall continue to grant EC type-approval of headlamps and light sources and to permit their sale and entry into service in accordance with previous versions of Directive 76/761/EEC provided that such headlamps and light sources
- are intended to be fitted to vehicles already in use, and
- comply with the requirements of that Directive which were applicable when the vehicles were first registered.
Article 3
The paragraphs and annexes of UN-ECE Regulations Nos 1, 5, 8, 20, 31, 37, 98 and 99, referred to in Annexes II, III, IV, V, VI, VII, VIII and IX, items 2.1, shall be published in the Official Journal of the European Communities before 1 April 1999.
Article 4
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 October 1999; however, if the publication of the texts referred to in Article 3 is delayed beyond 1 April 1999, the Member States shall comply with this obligation six months after the actual date of publication of these texts. They shall forthwith inform the Commission thereof.
They shall apply those provisions from 1 October 1999, or, if the publication of the texts referred to in Article 3 is delayed beyond 1 April 1999, six months after the actual date of publication of those texts.
When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.
Article 5
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.
Article 6
This Directive is addressed to the Member States.
|
[
"UKSI19992324"
] |
31999L0020
|
1999
|
Council Directive 1999/20/EC of 22 March 1999 amending Directives 70/524/EEC concerning additives in feedingstuffs, 82/471/EEC concerning certain products used in animal nutrition, 95/53/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition and 95/69/EC laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector
Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas Articles 13 to 16 of Directive 70/524/EEC (4), as amended by Directive 96/51/EC (5), lay down certain provisions on the distribution and incorporation in feedingstuffs of additives and premixtures and the labelling of additives, premixtures and compound feedingstuffs;
Whereas Directive 82/471/EEC (6) makes provision in Article 3 and in the Annex for certain measures for the distribution and labelling of those products;
Whereas the deadline of 1 April 1998 laid down for implementation by the Member States of the amendments to Directives 70/524/EEC and 82/471/EEC, introduced respectively by Directive 96/51/EC and Directive 95/69/EC (7) is incompatible with the dates laid down by Directive 95/69/EC for the completion of approval procedures (1 April 2001) and registration procedures (1 September 1998) for certain establishments and intermediaries operating in the animal feed sector; whereas the provisions in question apply without prejudice to the deadlines laid down in Directive 95/69/EC; whereas Directives 70/524/EEC and 82/471/EEC must nevertheless be amended for reasons of legal consistency;
Whereas Council Directive 95/53/EC of 25 October 1995 fixing the principles governing the organisation of official inspections in the field of animal nutrition (8) must cover all products and substances used in animal feedingstuffs in the Community;
Whereas, in order to achieve that objective, Directive 96/25/EC should be included in the list of legislation to which Directive 95/53/EC applies; whereas the reference to Council Directive 77/101/EEC of 23 November 1976 on the marketing of straight feedingstuffs (9) should be deleted from that list, as it has since been repealed by Directive 96/25/EC;
Whereas Directive 95/69/EC lays down that each year Member States must send the other Member States a list of approved establishments; whereas the procedures for the approval of establishments must be completed by 1 April 2001; whereas, in the mean time, it is therefore necessary, with a view to official inspections in the field of animal nutrition, in particular on trade within the Community, that the communication should also include establishments which, although not yet approved, can, in accordance with the conditions laid down by the Directive, continue to carry out their activities;
Whereas Directives 70/524/EC, 82/471/EEC, 95/53/EC and 95/69/EC should therefore be amended accordingly,
Article 1
Directive 70/524/EEC is hereby amended as follows:
1. in Article 13, the following paragraph shall be added:
'6. Paragraphs 1 to 3 shall apply without prejudice to Article 4(2) and Article 9(2) of Directive 95/69/EC`.
2. The following Article shall be inserted:
'Article 16a
Articles 14 to 16 referring to the approval and registration numbers provided for in Directive 95/69/EC shall apply from 1 April 2001`.
Article 2
Directive 82/471/EEC is hereby amended as follows:
1. in Article 3, the following paragraph shall be added:
'4. Paragraph 3 shall apply without prejudice to Article 4(2) of Directive 95/69/EC`.
2. In the Annex, for the products referred to in Chapter 1, point 1(a) of Directive 95/69/EC, in column 7 ('special provisions`), the final indent in the details to be given on the packaging of the product, on the container or on a label affixed thereto shall be replaced by the following text:
'- as from 1 April 2001: approval number`.
Article 3
In Directive 95/53/EC, in Article 2(1)(a), the third indent shall be replaced by the following:
'- Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC`.
Article 4
In Directive 95/69/EC in Article 6(2), the second and third sentences shall be replaced by the following:
'Before 31 December each year, Member States shall send to the other Member States a list of the establishments referred to in Article 2(2)(a) and (b) and of the intermediaries approved in accordance with Article 3(1) and a list of corresponding establishments and intermediaries referred to in Article 4(2) which have submitted applications for approval on which the Member States have not yet taken a decision.
On request, the Member States shall send the other Member States all, or part of the list of establishments referred to in Article 2(2)(c) to (f) and all or part of the list of corresponding establishments referred to in Article 4(2) which have submitted applications for approval on which the Member States have not yet taken a decision`.
Article 5
1. By 30 September 1999, Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof. The Member States shall apply the measures from 1 October 1999.
2. When Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by Member States.
3. Member States shall send the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive.
Article 6
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 7
This Directive is addressed to the Member States.
|
[
"UKSI20002481"
] |
31999L0022
|
1999
|
Council Directive 1999/22/EC of 29 March 1999 relating to the keeping of wild animals in zoos
Having regard to the Treaty establishing the European Community, and in particular Article 130s(1) thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the Economic and Social Committee(1),
Acting in accordance with the procedure laid down in Article 189c of the Treaty(2),
Whereas Council Regulation (EEC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein(3) requires evidence of the availability of adequate facilities for the accomodation and care of live specimens of a great many species before their importation into the Community is authorised; whereas that Regulation prohibits the display to the public for commercial purposes of specimens of species listed in Annex A thereof unless a specific exemption was granted for education, research or breeding purposes;
Whereas Council Directive 79/409/EEC of 2 April 1979 on the conservation of wild birds(4), and Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora(5), prohibit the capture and keeping of and trade in a great number of species, whilst providing for exemptions for specific reasons, such as research and education, repopulation, reintroduction and breeding;
Whereas the proper implementation of existing and future Community legislation on the conservation of wild fauna and the need to ensure that zoos adequately fulfil their important role in the conservation of species, public education, and/or scientific research make it necessary to provide a common basis for Member States' legislation with regard to the licensing and inspection of zoos, the keeping of animals in zoos, the training of staff and the education of the visiting public;
Whereas action at the Community level is required in order to have zoos throughout the Community contributing to the conservation of biodiversity in accordance with the Community's obligation to adopt measures for ex situ conservation under Article 9 of the Convention on Biological Diversity;
Whereas a number of organisations such as the European Association of Zoos and Aquaria have produced guidelines for the care and accomodation of animals in zoos which could, where appropriate, assist in the development and adoption of national standards,
Article 1
Aim
The objectives of this Directive are to protect wild fauna and to conserve biodiversity by providing for the adoption of measures by Member States for the licensing and inspection of zoos in the Community, thereby strengthening the role of zoos in the conservation of biodiversity.
Article 2
Definition
For the purpose of this Directive, "zoos" means all permanent establishments where animals of wild species are kept for exhibition to the public for 7 or more days a year, with the exception of circuses, pet shops and establishments which Member States exempt from the requirements of this Directive on the grounds that they do not exhibit a significant number of animals or species to the public and that the exemption will not jeopardise the objectives of this Directive.
Article 3
Requirements applicable to zoos
Member States shall take measures under Articles 4, 5, 6 and 7 to ensure all zoos implement the following conservation measures:
- participating in research from which conservation benefits accrue to the species, and/or training in relevant conservation skills, and/or the exchange of information relating to species conservation and/or, where appropriate, captive breeding, repopulation or reintroduction of species into the wild,
- promoting public education and awareness in relation to the conservation of biodiversity, particularly by providing information about the species exhibited and their natural habitats,
- accommodating their animals under conditions which aim to satisfy the biological and conservation requirements of the individual species, inter alia, by providing species specific enrichment of the enclosures; and maintaining a high standard of animal husbandry with a developed programme of preventive and curative veterinary care and nutrition,
- preventing the escape of animals in order to avoid possible ecological threats to indigenous species and preventing intrusion of outside pests and vermin,
- keeping of up-to-date records of the zoo's collection appropriate to the species recorded.
Article 4
Licensing and inspection
1. Member States shall adopt measures for licensing and inspection of existing and new zoos in order to ensure that the requirements of Article 3 are met.
2. Every zoo shall have a licence within four years after the entry into force of this Directive or, in the case of new zoos, before they are open to the public.
3. Each licence shall contain conditions to enforce the requirements of Article 3. Compliance with the conditions shall be monitored inter alia by means of regular inspection and appropriate steps shall be taken to ensure such compliance.
4. Before granting, refusing, extending the period of, or significantly amending a licence, an inspection by Member States' competent authorities shall be carried out in order to determine whether or not the licensing conditions or proposed licensing conditions are met.
5. If the zoo is not licensed in accordance with this Directive or the licensing conditions are not met, the zoo or part thereof:
(a) shall be closed to the public by the competent authority; and/or
(b) shall comply with appropriate requirements imposed by the competent authority to ensure that the licensing conditions are met.
Should these requirements not be complied with within an appropriate period to be determined by the competent authorities but not exceeding two years, the competent authority shall withdraw or modify the licence and close the zoo or part thereof.
Article 5
Licensing requirements set out in Article 4 shall not apply where a Member State can demonstrate to the satisfaction of the Commission that the objective of this Directive as set out in Article 1 and the requirements applicable to zoos set out in Article 3 are being met and continously maintained by means of a system or regulation and registration. Such a system should, inter alia, contain provisions regarding inspection and closure of zoos equivalent to those in Article 4(4) and (5).
Article 6
Closure of zoos
In the event of a zoo or part thereof being closed, the competent authority shall ensure that the animals concerned are treated or disposed of under conditions which the Member State deems appropriate and consistent with the purposes and provisions of this Directive.
Article 7
Competent authorities
Member States shall designate competent authorities for the purposes of this Directive.
Article 8
Penalties
Member States shall determine the penalties applicable to breaches of the national provisions adopted pursuant to this Directive. The penalties shall be effective, proportionate and dissuasive.
Article 9
Implementation
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this directive not later than 9 April 2002. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the main provisions of national law which they adopt in the field covered by this Directive.
Article 10
Entry in force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 11
This Directive is addressed to the Member States.
|
[
"UKSI20023080"
] |
31999L0023
|
1999
|
Commission Directive 1999/23/EC of 9 April 1999 adapting to technical progress Council Directive 93/33/EEC on protective devices intended to prevent the unauthorised use of two- or three-wheel motor vehicles (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two- or three-wheel motor vehicles(1), as amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 16 thereof,
Having regard to Council Directive 93/33/EEC of 14 June 1993 on protective devices intended to prevent the unauthorised use of two- or three-wheel motor vehicles(2), and in particular Article 4 thereof,
(1) Whereas Directive 93/33/EEC is one of the separate Directives of the Community type-approval procedure introduced by Directive 92/61/EEC; whereas the provisions of Directive 92/61/EEC relating to vehicle systems, components and technical units therefore apply to that Directive;
(2) Whereas developments in technology now permit an adaptation of Council Directive 93/33/EEC to technical progress; whereas in order to ensure the proper functioning of the type-approval system as a whole, it is therefore necessary to clarify or complete certain provisions of the Directive concerned;
(3) Whereas to this end it is necessary to adapt the provisions relating to the locking angle of the steering of quadricycles and those relating to the removal of the key from type-3 devices designed to be fitted to tricycles and quadricycles; whereas, moreover, it is deemed appropriate to allow two- and three-wheel motor vehicles to be fitted with protective devices against unauthorised use which are approved for four-wheel motor vehicles;
(4) Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for adaptation to technical progress set up by Article 13 of Council Directive 70/156/EEC(3), as last amended by Directive 98/91/EC of the European Parliament and of the Council(4),
Article 1
Annex I to Directive 93/33/EEC is hereby amended in accordance with the Annex to this Directive.
Article 2
1. With effect from 1 January 2000, Member States shall not, on grounds relating to protective devices intended to prevent unauthorised use:
- refuse, in respect of a type of two- or three-wheel vehicle or a type of protective device intended to prevent unauthorised use, to grant EC type-approval,
- prohibit the registration, sale or entry into service of two- or three-wheel motor vehicles, or the sale or entry into service of protective devices intended to prevent unauthorised use,
if the protective devices intended to prevent unauthorised use comply with the requirements of Directive 93/33/EEC as amended by this Directive.
2. With effect from 1 July 2000, Member States shall refuse to grant EC type-approval for any type of two- or three-wheel motor vehicle on grounds relating to protective devices intended to prevent unauthorised use or any type of protective device intended to prevent unauthorised use if the requirements of Directive 93/33/EEC, as amended by this Directive, are not fulfilled.
Article 3
1. Member States shall adopt and publish, no later than 31 December 1999, the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.
They shall apply those provisions from 1 January 2000.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the texts of the main provisions of national law that they adopt in the field governed by this Directive.
Article 4
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 5
This Directive is addressed to the Member States.
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[
"UKSI19992920"
] |
31999L0026
|
1999
|
Commission Directive 1999/26/EC of 20 April 1999 adapting to technical progress Council Directive 93/94/EEC relating to the space for mounting the rear registration plate of two or three-wheel motor vehicles (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two or three-wheel motor vehicles(1), as amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 16 thereof,
Having regard to Council Directive 93/94/EEC of 29 October 1993 relating to the space for mounting the rear registration plate of two or three-wheel motor vehicles(2), and in particular Article 3 thereof,
(1) Whereas Directive 93/94/EEC is one of the separate Directives of the Community type-approval procedure introduced by Directive 92/61/EEC; whereas the provisions of Directive 92/61/EEC relating to vehicle systems, components and technical units therefore apply to that Directive;
(2) Whereas developments in technology now permit an adaptation of Council Directive 93/94/EEC to technical progress; whereas in order to ensure the proper functioning of the type-approval system as a whole, it is therefore necessary to clarify or complete certain provisions of the Directive concerned;
(3) Whereas to this end it is necessary to adapt the provisions relating to the load conditions of vehicles when measuring the inclination and those relating to the dimensions of spaces for mounting the rear registration plate of quadricycles fitted with a body as well as to align Figure 1 on the actual position of vehicles during tests and to better specify certain references in the information document;
(4) Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress set up by Article 13 of Council Directive 70/156/EEC(3), as last amended by Directive 98/91/EC of the European Parliament and of the Council(4),
Article 1
The Annex to Directive 93/94/EEC is hereby amended in accordance with the Annex to this Directive.
Article 2
1. With effect from 1 January 2000, Member States shall not, on grounds relating to the space for mounting the rear registration plate:
- refuse, in respect of a type of two or three-wheel vehicle, to grant EC type-approval,
- prohibit the registration, sale or entry into service of two or three-wheel motor vehicles,
if the space for mounting the rear registration plate complies with the requirements of Directive 93/94/EEC as amended by this Directive.
2. With effect from 1 July 2000, Member States shall refuse to grant EC type-approval for any type of two or three-wheel motor vehicle on grounds relating to the space for mounting the rear registration plate if the requirements of Directive 93/94/EEC, as amended by this Directive, are not fulfilled.
Article 3
1. Member States shall adopt and publish, no later than 31 December 1999, the provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.
They shall apply those provisions from 1 January 2000.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the texts of the main provisions of national law that they adopt in the field governed by this Directive.
Article 4
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 5
This Directive is addressed to the Member States.
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[
"UKSI19992920"
] |
31999L0028
|
1999
|
Commission Directive 1999/28/EC of 21 April 1999 amending the Annex to Council Directive 92/14/EEC on the limitation of the operation of aeroplanes covered by Part II, Chapter 2, Volume 1 of Annex 16 to the Convention on International Civil Aviation, second edition (1988) (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 92/14/EEC of 2 March 1992 on the limitation of the operation of aeroplanes covered by Part II, Chapter 2, Volume 1 of Annex 16 to the Convention on International Civil Aviation, second edition (1988)(1), as last amended by Directive 98/20/EC(2), and in particular Article 9a thereof,
(1) Whereas Article 3 of Directive 92/14/EEC exempts the aeroplanes listed in the Annex thereto, provided, in particular, that they continue to be used by natural or legal persons established in the nation of registration of the reference period;
(2) Whereas Article 9a of Directive 92/14/EEC provides for a simplified procedure for amendments to the Annex with a view to ensuring full conformity with the eligibility criteria;
(3) Whereas, some aeroplanes included in the Annex have been destroyed and others have been removed from the register of the relevant developing nation, and amendments to the Annex are therefore required;
(4) Whereas the provisions of this Directive are in accordance with the opinion of the Aviation Safety Regulation Committee established by Council Regulation (EEC) No 3922/91(3)(4), as amended by Commission Regulation (EC) No 2176/96(5),
Article 1
The Annex to Directive 92/14/EEC is hereby amended as set out in the Annex to this Directive.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 September 1999 at the latest. They shall forthwith inform the Commission thereof.
When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
2. Member States shall communicate to the Commission the text of the main provisions of domestic law that they adopt in the field governed by this Directive.
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI19992253"
] |
31999L0030
|
1999
|
Council Directive 1999/30/EC of 22 April 1999 relating to limit values for sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead in ambient air
Having regard to the Treaty establishing the European Community, and in particular Article 130s(1) thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 189c of the Treaty(3),
(1) Whereas, on the basis of principles enshrined in Article 130r of the Treaty, the European Community programme of policy and action in relation to the environment and sustainable development (the fifth Environment Action Programme)(4) envisages in particular amendments to legislation on air pollutants; whereas that programme recommends the establishment of long-term air-quality objectives;
(2) Whereas Article 129 of the Treaty provides that health-protection requirements shall form a constituent part of the Community's other policies; whereas Article 3(o) of the Treaty provides that the activities of the Community shall include a contribution to the attainment of a high level of health protection;
(3) Whereas, pursuant to Article 4(5) of Council Directive 96/62/EC of 27 September 1996 on ambient air quality assessment and management(5), the Council is to adopt the legislation provided for in paragraph 1 and the provisions laid down in paragraphs 3 and 4 of the same Article;
(4) Whereas the limit values laid down in this Directive are minimum requirements; whereas, in accordance with Article 130t of the Treaty, Member States may maintain or introduce more stringent protective measures; whereas, in particular, stricter limit values may be introduced to protect the health of particularly vulnerable categories of the population, such as children and hospital patients; whereas a Member State may require that limit values be attained before the dates laid down in this Directive;
(5) Whereas ecosystems should be protected against the adverse effects of sulphur dioxide; whereas vegetation should be protected against the adverse effects of oxides of nitrogen;
(6) Whereas different types of particles can have different harmful effects on human health; whereas there is evidence that risks to human health associated with exposure to man-made particulate matter are higher than risks associated with exposure to naturally occurring particles in ambient air;
(7) Whereas Directive 96/62/EC requires that action plans be developed for zones within which concentrations of pollutants in ambient air exceed limit values plus any temporary margins of tolerance applicable in order to ensure compliance with limit values by the date or dates laid down; whereas insofar as they relate to particulate matter such action plans and other reduction strategies should aim to reduce concentrations of fine particles as part of the total reduction in concentrations of particulate matter;
(8) Whereas Directive 96/62/EC provides that the numerical values for limit values and alert thresholds are to be based on the findings of work carried out by international scientific groups active in the field; whereas the Commission is to take account of the most recent scientific-research data in the epidemiological and environmental fields concerned and of the most recent advances in metrology for re-examining the elements on which limit values and alert thresholds are based;
(9) Whereas in order to facilitate the review of this Directive in 2003 the Commission and the Member States should consider encouraging research into the effects of the pollutants referred to herein, namely sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead;
(10) Whereas standardised accurate measurement techniques and common criteria for the location of measuring stations are an important element in the assessment of ambient-air quality with a view to obtaining comparable information across the Community;
(11) Whereas, in accordance with Article 12(1) of Directive 96/62/EC, the amendments necessary for adaptation to scientific and technical progress may relate solely to criteria and techniques for the assessment of concentrations of sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead or detailed arrangements for forwarding information to the Commission, and may not have the effect of modifying limit values or alert thresholds either directly or indirectly;
(12) Whereas up-to-date information on concentrations of sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead in ambient air should be readily available to the public,
Article 1
Objectives
The objectives of this Directive shall be to:
- establish limit values and, as appropriate, alert thresholds for concentrations of sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead in ambient air intended to avoid, prevent or reduce harmful effects on human health and the environment as a whole,
- assess concentrations of sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead in ambient air on the basis of common methods and criteria,
- obtain adequate information on concentrations of sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead in ambient air and ensure that it is made available to the public,
- maintain ambient-air quality where it is good and improve it in other cases with respect to sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead.
Article 2
Definitions
For the purposes of this Directive:
1. "ambient air" shall mean outdoor air in the troposphere, excluding work places;
2. "pollutant" shall mean any substance introduced directly or indirectly by man into the ambient air and likely to have harmful effects on human health and/or the environment as a whole;
3. "level" shall mean the concentration of a pollutant in ambient air or the deposition thereof on surfaces in a given time;
4. "assessment" shall mean any method used to measure, calculate, predict or estimate the level of a pollutant in the ambient air;
5. "limit value" shall mean a level fixed on the basis of scientific knowledge, with the aim of avoiding, preventing or reducing harmful effects on human health and/or the environment as a whole, to be attained within a given period and not to be exceeded once attained;
6. "alert threshold" shall mean a level beyond which there is a risk to human health from brief exposure and at which immediate steps shall be taken by the Member States as laid down in Directive 96/62/EC;
7. "margin of tolerance" shall mean the percentage of the limit value by which this value may be exceeded subject to the conditions laid down in Directive 96/62/EC;
8. "zone" shall mean part of their territory delimited by the Member States;
9. "agglomeration" shall mean a zone with a population concentration in excess of 250000 inhabitants or, where the population concentration is 250000 inhabitants or less, a population density per km2 which for the Member States justifies the need for ambient air quality to be assessed and managed.
10. "oxides of nitrogen" shall mean the sum of nitric oxide and nitrogen dioxide added as parts per billion and expressed as nitrogen dioxide in micrograms per cubic meter;
11. "PM10" shall mean particulate matter which passes through a size-selective inlet with a 50 % efficiency cut-off at 10 μm aerodynamic diameter;
12. "PM2,5" shall mean particulate matter which passes through a size-selective inlet with a 50 % efficiency cut-off at 2,5μm aerodynamic diameter;
13. "upper assessment threshold" shall mean a level specified in Annex V, below which a combination of measurements and modelling techniques may be used to assess ambient-air quality, in accordance with Article 6(3) of Directive 96/62/EC;
14. "lower assessment threshold" shall mean a level specified in Annex V, below which modelling or objective-estimation techniques alone may be used to assess ambient-air quality in accordance with Article 6(4) of Directive 96/62/EC;
15. "natural events" shall mean volcanic eruptions, seismic activities, geothermal activities, wild-land fires, high-wind events or the atmospheric resuspension or transport of natural particles from dry regions;
16. "fixed measurements" shall mean measurements taken in accordance with Article 6(5) of Directive 96/62/EC.
Article 3
Sulphur dioxide
1. Member States shall take the measures necessary to ensure that concentrations of sulphur dioxide in ambient air, as assessed in accordance with Article 7, do not exceed the limit values laid down in Section I of Annex I from the dates specified therein.
The margins of tolerance laid down in Section I of Annex I shall apply in accordance with Article 8 of Directive 96/62/EC.
2. The alert threshold for concentrations of sulphur dioxide in ambient air shall be that laid down in Section II of Annex I.
3. In order to assist the Commission in preparing the report provided for in Article 10, until 31 December 2003 Member States shall, where practicable, record data on concentrations of sulphur dioxide averaged over ten minutes from certain measuring stations which they have selected as representative of air quality in inhabited areas close to sources and at which hourly concentrations are measured. At the same time as data are supplied on hourly concentrations in accordance with Article 11(1) of Directive 96/62/EC, Member States shall report to the Commission, for those selected measuring stations, the number of ten-minute concentrations which have exceeded 500 μg/m3, the number of days within the calendar year on which that occurred, the number of those days on which hourly concentrations of sulphur dioxide simultaneously exceeded 350 μg/m3 and the maximum ten-minute concentration recorded.
4. Member States may designate zones or agglomerations within which limit values for sulphur dioxide as laid down in Section I of Annex I are exceeded owing to concentrations of sulphur dioxide in ambient air due to natural sources. Member States shall send the Commission lists of any such zones or agglomerations together with information on concentrations and sources of sulphur dioxide therein. When informing the Commission in accordance with Article 11(1) of Directive 96/62/EC, Member States shall provide the necessary justification to demonstrate that any exceedances are due to natural sources.
Within such zones or agglomerations Member States shall be obliged to implement action plans in accordance with Article 8(3) of Directive 96/62/EC only where the limit values laid down in Section I of Annex I are exceeded owing to man-made emissions.
Article 4
Nitrogen dioxide and oxides of nitrogen
1. Member States shall take the measures necessary to ensure that concentrations of nitrogen dioxide and, where applicable, of oxides of nitrogen, in ambient air, as assessed in accordance with Article 7, do not exceed the limit values laid down in Section I of Annex II as from the dates specified therein.
The margins of tolerance laid down in Section I of Annex II shall apply in accordance with Article 8 of Directive 96/62/EC.
2. The alert threshold for concentrations of nitrogen dioxide in ambient air shall be that laid down in Section II of Annex II.
Article 5
Particulate matter
1. Member States shall take the measures necessary to ensure that concentrations of PM10 in ambient air, as assessed in accordance with Article 7, do not exceed the limit values laid down in Section I of Annex III as from the dates specified therein.
The margins of tolerance laid down in Section I of Annex III shall apply in accordance with Article 8 of Directive 96/62/EC.
2. Member States shall ensure that measuring stations to supply data on concentrations of PM2,5 are installed and operated. Each Member State shall choose the number and the siting of the stations at which PM2,5 is to be measured as representative of concentrations of PM2,5 within that Member State. Where possible sampling points for PM2,5 shall be co-located with sampling points for PM10.
Within nine months of the end of each year Member States shall send the Commission the arithmetic mean, the median, the ninety-eighth percentile and the maximum concentration calculated from measurements of PM2,5 over any twenty-four hours within that year. The ninety-eighth percentile shall be calculated in accordance with the procedure laid down in Section 4 of Annex I to Council Decision 97/101/EC of 27 January 1997 establishing a reciprocal exchange of information and data from networks and individual stations measuring ambient air pollution within the Member States(6).
3. Action plans for PM10 prepared in accordance with Article 8 of Directive 96/62/EC and general strategies for decreasing concentrations of PM10 shall also aim to reduce concentrations of PM2,5.
4. Where the limit values for PM10 laid down in Section I of Annex III are exceeded owing to concentrations of PM10 in ambient air due to natural events which result in concentrations significantly in excess of normal background levels from natural sources, Member States shall inform the Commission in accordance with Article 11(1) of Directive 96/62/EC, providing the necessary justification to demonstrate that such exceedances are due to natural events. In such cases, Member States shall be obliged to implement action plans in accordance with Article 8(3) of Directive 96/62/EC only where the limit values laid down in Section I of Annex III are exceeded owing to causes other than natural events.
5. Member States may designate zones or agglomerations within which limit values for PM10 as laid down in Section I of Annex III are exceeded owing to concentrations of PM10 in ambient air due to the resuspension of particulates following the winter sanding of roads. Member States shall send the Commission lists of any such zones or agglomerations together with information on concentrations and sources of PM10 therein. When informing the Commission in accordance with Article 11(1) of Directive 96/62/EC, Member States shall provide the necessary justification to demonstrate that any exceedances are due to such resuspended particulates, and that reasonable measures have been taken to lower the concentrations.
Within such zones or agglomerations Member States shall be obliged to implement action plans in accordance with Article 8(3) of Directive 96/62/EC only where the limit values laid down in Section I of Annex III are exceeded owing to PM10 levels other than those caused by winter road sanding.
Article 6
Lead
Member States shall take the measures necessary to ensure that concentrations of lead in ambient air, as assessed in accordance with Article 7, do not exceed the limit values laid down in Section I of Annex IV as from the dates specified therein.
The margins of tolerance laid down in Section I of Annex IV shall apply in accordance with Article 8 of Directive 96/62/EC.
Article 7
Assessment of concentrations
1. The upper and lower assessment thresholds for sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead for the purposes of Article 6 of Directive 96/62/EC shall be those laid down in Section I of Annex V.
The classification of each zone or agglomeration for the purposes of the same Article 6 shall be reviewed at least every five years in accordance with the procedure laid down in Section II of Annex V. Classification shall be reviewed earlier in the event of significant changes in activities relevant to ambient concentrations of sulphur dioxide, nitrogen dioxide or, where relevant, oxides of nitrogen, particulate matter or lead.
2. The criteria for determining the location of sampling points for the measurement of sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead in ambient air shall be those listed in Annex VI. The minimum number of sampling points for fixed measurements of concentrations of each relevant pollutant shall be as laid down in Annex VII and they shall be installed in each zone or agglomeration within which measurement is required if fixed measurement is the sole source of data on concentrations within it.
3. For zones and agglomerations within which information from fixed measurement stations is supplemented by information from other sources, such as emission inventories, indicative measurement methods and air-quality modelling, the number of fixed measuring stations to be installed and the spatial resolution of other techniques shall be sufficient for the concentrations of air pollutants to be established in accordance with Section I of Annex VI and Section I of Annex VIII.
4. For zones and agglomerations within which measurement is not required, modelling or objective-estimation techniques may be used.
5. The reference methods for the analysis of sulphur dioxide, of nitrogen dioxide and of oxides of nitrogen and for the sampling and analysis of lead shall be as laid down in Sections I to III of Annex IX.
The reference method for the sampling and measurement of PM10 shall be as laid down in Section IV of Annex IX.
The provisional reference method for the sampling and measurement of PM2,5 shall be as laid down in Section V of Annex IX.
The reference techniques for air-quality modelling shall be as laid down in Section VI of Annex IX.
6. The date by which Member States shall inform the Commission of the methods they have used for the preliminary assessment of air quality under Article 11(1)(d) of Directive 96/62/EC shall be eighteen months after the entry into force of this Directive.
7. Any amendments necessary to adapt this Article and Annexes V to IX to scientific and technical progress shall be adopted in accordance with the procedure laid down in Article 12 of Directive 96/62/EC.
Article 8
Public information
1. Member States shall ensure that up-to-date information on ambient concentrations of sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead is routinely made available to the public as well as to appropriate organisations such as environmental organisations, consumer organisations, organisations representing the interests of sensitive populations and other relevant health-care bodies by means, for example, of broadcast media, press, information screens or computer-network services.
Information on ambient concentrations of sulphur dioxide, nitrogen dioxide and particulate matter shall be updated on at least a daily basis, and, in the case of hourly values for sulphur dioxide and nitrogen dioxide, wherever practicable, information shall be updated on an hourly basis. Information on ambient concentrations of lead shall be updated on a three-monthly basis.
Such information shall at least indicate any exceeding of the concentrations in the limit values and alert thresholds over the averaging periods laid down in Annexes I to IV. It shall also provide a short assessment in relation to limit values and alert thresholds and appropriate information regarding effects on health.
2. When making plans or programmes available to the public under Article 8(3) of Directive 96/62/EC, including plans or programmes referred to under Articles 3(4), 5(4) and 5(5) of this Directive, Member States shall also make them available to the organisations referred to in paragraph 1.
3. When an alert threshold laid down in Annex I or II is exceeded, details made available to the public in accordance with Article 10 of Directive 96/62/EC shall at least include the items listed in Section III of the Annex in question.
4. Information made available to the public and to organisations under paragraphs 1 and 3 shall be clear, comprehensible and accessible.
Article 9
Repeals and transitional arrangements
1. Council Directive 80/779/EEC of 15 July 1980 on air-quality limit values and guide values for sulphur dioxide and suspended particulates(7) shall be repealed with effect from 19 July 2001 except that Articles 1, 2(1), 3(1), 9, 15 and 16 of Directive 80/779/EEC and Annexes I, IIIb and IV thereto shall be repealed with effect from 1 January 2005.
2. Council Directive 82/884/EEC of 3 December 1982 on a limit value for lead in the air(8) shall be repealed with effect from 19 July 2001 except that Articles 1, 2, 3(1), 7, 12 and 13 of Directive 82/884/EEC shall be repealed with effect from 1 January 2005.
3. Council Directive 85/203/EEC of 7 March 1985 on air-quality standards for nitrogen dioxide(9) shall be repealed with effect from 19 July 2001 except that Articles 1(1), first indent, and (2), 2, first indent, 3(1), 5, 9, 15 and 16 of Directive 85/203/EEC and Annex I thereto shall be repealed with effect from 1 January 2010.
4. From 19 July 2001 Member States shall employ measurement stations and other methods of air-quality assessment that comply with this Directive to assess concentrations of sulphur dioxide, nitrogen dioxide and lead in ambient air to obtain data for the purpose of demonstrating compliance with the limit values laid down in Directives 80/779/EEC, 82/884/EEC and 85/203/EEC until such time as the limit values laid down in those Directives cease to apply.
5. From 19 July 2001 Member States may employ measurement stations and other methods of air-quality assessment that comply with this Directive as regards PM10 to assess concentrations of suspended particulate matter for the purpose of demonstrating compliance with the limit values for total suspended particulates laid down in Annex IV to Directive 80/779/EEC; for the purpose of demonstrating such compliance, however, the data so collected shall be multiplied by a factor of 1.2.
6. Member States shall inform the Commission of any exceedances of the limit values laid down in Directives 80/779/EEC, 82/884/EEC and 85/203/EEC, together with the values recorded, the reasons for each recorded instance and the measures taken to prevent any recurrence, within nine months of the end of each year in accordance with the procedure laid down in Article 11 of Directive 96/62/EC until such time as the limit values laid down in those Directives cease to apply.
7. In the zones in which a Member State considers it necessary to limit or prevent a foreseeable increase in pollution by sulphur dioxide, oxides of nitrogen or suspended particulate matter it may continue to use the guide values for the protection of ecosystems laid down in Annex II to Directive 80/779/EEC and in Annex II to Directive 85/203/EEC.
Article 10
Report and review
No later than 31 December 2003 the Commission shall submit to the European Parliament and the Council a report based on the experience acquired in the application of this Directive and, in particular, on the results of the most recent scientific research concerning the effects on human health and ecosystems of exposure to sulphur dioxide, nitrogen dioxide and oxides of nitrogen, different fractions of particulate matter and lead, and on technological developments including the progress achieved in methods of measuring and otherwise assessing concentrations of particulate matter in ambient air and the deposition of particulate matter and lead on surfaces.
With a view to maintaining a high level of protection of human health and the environment and taking into account the experience acquired in the application of this Directive in Member States including, in particular, the conditions as laid down in Annex VI under which measurement has been carried out, the aforementioned report will be accompanied by proposals for the amendment of this Directive if appropriate. In particular, the Commission will examine the limit values for the second stage for PM10 with a view to making them mandatory and will consider confirming or altering the limit values for the second stage and, if appropriate, for the first stage. In addition, the Commission will give particular attention to setting limit values for PM2,5 or different fractions of particulate matter, as appropriate. Furthermore the Commission will examine the annual limit value for the protection of human health for nitrogen dioxide and will make a proposal confirming or modifying that value. It will also examine the hourly limit value for nitrogen dioxide in the light of World Health Organisation guidelines and consider whether that limit value should be confirmed or altered.
The Commission will also consider whether alert thresholds can be set, consistent with other pollutants in this Directive, for PM10, PM2,5 or particular fractions of particulate matter, as appropriate.
Article 11
Penalties
Member States shall determine the penalties applicable to breaches of the national provisions adopted pursuant to this Directive. Those penalties shall be effective, proportionate and dissuasive.
Article 12
Implementation
1. The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 19 July 2001. They shall forthwith inform the Commission thereof.
When the Member States adopt those measures, these shall contain references to this Directive or shall be accompanied by such references on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
2. The Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.
Article 13
Entry into force
This Directive shall enter into force on the twentieth day after that of its publication in the Official Journal of the European Communities.
Article 14
Addressees
This Directive is addressed to the Member States.
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[
"UKSI20012315"
] |
31999L0031
|
1999
|
Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste
Having regard to the Treaty establishing the European Community, and in particular Article 130s(1) thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 189c of the Treaty(3),
(1) Whereas the Council resolution of 7 May 1990(4) on waste policy welcomes and supports the Community strategy document and invites the Commission to propose criteria and standards for the disposal of waste by landfill;
(2) Whereas the Council resolution of 9 December 1996 on waste policy considers that, in the future, only safe and controlled landfill activities should be carried out throughout the Community;
(3) Whereas the prevention, recycling and recovery of waste should be encouraged as should the use of recovered materials and energy so as to safeguard natural resources and obviate wasteful use of land;
(4) Whereas further consideration should be given to the issues of incineration of municipal and non-hazardous waste, composting, biomethanisation, and the processing of dredging sludges;
(5) Whereas under the polluter pays principle it is necessary, inter alia, to take into account any damage to the environment produced by a landfill;
(6) Whereas, like any other type of waste treatment, landfill should be adequately monitored and managed to prevent or reduce potential adverse effects on the environment and risks to human health;
(7) Whereas it is necessary to take appropriate measures to avoid the abandonment, dumping or uncontrolled disposal of waste; whereas, accordingly, it must be possible to monitor landfill sites with respect to the substances contained in the waste deposited there, whereas such substances should, as far as possible, react only in foreseeable ways;
(8) Whereas both the quantity and hazardous nature of waste intended for landfill should be reduced where appropriate; whereas the handling of waste should be facilitated and its recovery enhanced; whereas the use of treatment processes should therefore be encouraged to ensure that landfill is compatible with the objectives of this Directive; whereas sorting is included in the definition of treatment;
(9) Whereas Member States should be able to apply the principles of proximity and self-sufficiency for the elimination of their waste at Community and national level, in accordance with Council Directive 75/442/EEC of 15 July 1975 on waste(5) whereas the objectives of this Directive must be pursued and clarified through the establishment of an adequate, integrated network of disposal plants based on a high level of environmental protection;
(10) Whereas disparities between technical standards for the disposal of waste by landfill and the lower costs associated with it might give rise to increased disposal of waste in facilities with low standards of environmental protection and thus create a potentially serious threat to the environment, owing to transport of waste over unnecessarily long distances as well as to inappropriate disposal practices;
(11) Whereas it is therefore necessary to lay down technical standards for the landfill of waste at Community level in order to protect, preserve and improve the quality of the environment in the Community;
(12) Whereas it is necessary to indicate clearly the requirements with which landfill sites must comply as regards location, conditioning, management, control, closure and preventive and protective measures to be taken against any threat to the environment in the short as well as in the long-term perspective, and more especially against the pollution of groundwater by leachate infiltration into the soil;
(13) Whereas in view of the foregoing it is necessary to define clearly the classes of landfill to be considered and the types of waste to be accepted in the various classes of landfill;
(14) Whereas sites for temporary storage of waste should comply with the relevant requirements of Directive 75/442/EEC;
(15) Whereas the recovery, in accordance with Directive 75/442/EEC, of inert or non-hazardous waste which is suitable, through their use in redevelopment/restoration and filling-in work, or for construction purposes may not constitute a landfilling activity;
(16) Whereas measures should be taken to reduce the production of methane gas from landfills, inter alia, in order to reduce global warming, through the reduction of the landfill of biodegradable waste and the requirements to introduce landfill gas control;
(17) Whereas the measures taken to reduce the landfill of biodegradable waste should also aim at encouraging the separate collection of biodegradable waste, sorting in general, recovery and recycling;
(18) Whereeas, because of the particular features of the landfill method of waste disposal, it is necessary to introduce a specific permit procedure for all classes of landfill in accordance with the general licensing requirements already set down in Directive 75/442/EEC and the general requirements of Directive 96/61/EC concerning integrated pollution prevention and control(6) whereas the landfill site's compliance with such a permit must be verified in the course of an inspection by the competent authority before the start of disposal operations;
(19) Whereas, in each case, checks should be made to establish whether the waste may be placed in the landfill for which it is intended, in particular as regards hazardous waste;
(20) Whereas, in order to prevent threats to the environment, it is necessary to introduce a uniform waste acceptance procedure on the basis of a classification procedure for waste acceptable in the different categories of landfill, including in particular standardised limit values; whereas to that end a consistent and standardised system of waste characterisation, sampling and analysis must be established in time to facilitate implementation of this Directive; whereas the acceptance criteria must be particularly specific with regard to inert waste;
(21) Whereas, pending the establishment of such methods of analysis or of the limit values necessary for characterisation, Member States may for the purposes of this Directive maintain or draw up national lists of waste which is acceptable or unacceptable for landfill, or define criteria, including limit values, similar to those laid down in this Directive for the uniform acceptance procedure;
(22) Whereas for certain hazardous waste to be accepted in landfills for non-hazardous waste acceptance criteria should be developed by the technical committee;
(23) Whereas it is necessary to establish common monitoring procedures during the operation and after-care phases of a landfill in order to indentify any possible adverse environmental effect of the landfill and take the appropriate corrective measures;
(24) Whereas it is necessary to define when and how a landfill should be closed and the obligations and responsibility of the operator on the site during the after-care period;
(25) Whereas landfill sites that have been closed prior to the date of transposition of this Directive should not be suject to its provisions on closure procedure;
(26) Whereas the future conditions of operation of existing landfills should be regulated in order to take the necessary measures, within a specified period of time, for their adaptation to this Directive on the basis of a site-conditioning plan;
(27) Whereas for operators of existing landfills having, in compliance with binding national rules equivalent to those of Article 14 of this Directive, already submitted the documentation referred to in Article 14(a) of this Directive prior to its entry into force and for which the competent authority authorised the continuation of their operation, there is no need to resubmit this documentation nor for the competent authority to deliver a new authorisation;
(28) Whereas the operator should make adequate provision by way of a financial security or any other equivalent to ensure that all the obligations flowing from the permit are fulfilled, including those relating to the closure procedure and after-care of the site;
(29) Whereas measures should be taken to ensure that the price charged for waste disposal in a landfill cover all the costs involved in the setting up and operation of the facility, including as far as possible the financial security or its equivalent which the site operator must provide, and the estimated cost of closing the site including the necessary after-care;
(30) Whereas, when a competent authority considers that a landfill is unlikely to cause a hazard to the environment for longer than a certain period, the estimated costs to be included in the price to be charged by an operator may be limited to that period;
(31) Whereas it is necessary to ensure the proper application of the provisions implementing this Directive throughout the Community, and to ensure that the training and knowledge acquired by landfill operators and staff afford them the necessary skills;
(32) Whereas the Commission must establish a standard procedure for the acceptance of waste and set up a standard classification of waste acceptable in a landfill in accordance with the committee procedure laid down in Article 18 of Directive 75/442/EEC;
(33) Whereas adaptation of the Annexes to this Directive to scientific and technical progress and the standardisation of the monitoring, sampling and analysis methods must be adopted under the same committee procedure;
(34) Whereas the Member States must send regular reports to the Commission on the implementation of this Directive paying particular attention to the national strategies to be set up in pursuance of Article 5; whereas on the basis of these reports the Commission shall report to the European Parliament and the Council;
Article 1
Overall objective
1. With a view to meeting the requirements of Directive 75/442/EEC, and in particular Articles 3 and 4 thereof, the aim of this Directive is, by way of stringent operational and technical requirements on the waste and landfills, to provide for measures, procedures and guidance to prevent or reduce as far as possible negative effects on the environment, in particular the pollution of surface water, groundwater, soil and air, and on the global environment, including the greenhouse effect, as well as any resulting risk to human health, from landfilling of waste, during the whole life-cycle of the landfill.
2. In respect of the technical characteristics of landfills, this Directive contains, for those landfills to which Directive 96/61/EC is applicable, the relevant technical requirements in order to elaborate in concrete terms the general requirements of that Directive. The relevant requirements of Directive 96/61/EC shall be deemed to be fulfilled if the requirements of this Directive are complied with.
Article 2
Definitions
For the purposes of this Directive:
(a) "waste" means any substance or object which is covered by Directive 75/442/EEC;
(b) "municipal waste" means waste from households, as well as other waste which, because of its nature or composition, is similar to waste from household;
(c) "hazardous waste" means any waste which is covered by Article 1(4) of Council Directive 91/689/EEC of 12 December 1991 on hazardous waste(7)
(d) "non-hazardous waste" means waste which is not covered by paragraph (c);
(e) "inert waste" means waste that does not undergo any significant physical, chemical or biological transformations. Inert waste will not dissolve, burn or otherwise physically or chemically react, biodegrade or adversely affect other matter with which it comes into contact in a way likely to give rise to environmental pollution or harm human health. The total leachability and pollutant content of the waste and the ecotoxicity of the leachate must be insignificant, and in particular not endanger the quality of surface water and/or groundwater;
(f) "underground storage" means a permanent waste storage facility in a deep geological cavity such as a salt or potassium mine;
(g) "landfill" means a waste disposal site for the deposit of the waste onto or into land (i.e. underground), including:
- internal waste disposal sites (i.e. landfill where a producer of waste is carrying out its own waste disposal at the place of production), and
- a permanent site (i.e. more than one year) which is used for temporary storage of waste,
but excluding:
- facilities where waste is unloaded in order to permit its preparation for further transport for recovery, treatment or dispsal elsewhere, and
- stoarage of waste prior to recovery or treatment for a period less than three years as a general rule, or
- storage of waste prior to disposal for a period less than one year;
(h) "treatment" means the physical, thermal, chemical or biological processes, including sorting, that change the characteristics of the waste in order to reduce its volume or hazardous nature, facilitate its handling or enhance recovery;
(i) "leachate" means any liquid percolating through the deposited waste and emitted from or contained within a landfill;
(j) "landfill gas" means all the gases generated from the landfilled waste;
(k) "eluate" means the solution obtained by a laboratory leaching test;
(l) "operator" means the natural or legal person responsible for a landfill in accordance with the internal legislation of the Member State where the landfill is located; this person may change from the preparation to the after-care phase;
(m) "biodegradable waste" means any waste that is capable of undergoing anaerobic or aerobic decomposition, such as food and garden waste, and paper and paperboard;
(n) "holder" means the producer of the waste or the natural or legal person who is in possession of it;
(o) "applicant" means any person who applies for a landfill permit under this Directive;
(p) "competent authority" means that authority which the Member States designate as responsible for performing the duties arising from this Directive;
(q) "liquid waste" means any waste in liquid form including waste waters but excluding sludge;
(r) "isolated settlement" means a settlement:
- with no more than 500 inhabitants per municipality or settlement and no more than five inhabitants per square kilometre and,
- where the distance to the nearest urban agglomeration with at least 250 inhabitants per square kilometre is not less than 50 km, or with difficult access by road to those nearest agglomerations, due to harsh meteorological conditions during a significant part of the year.
Article 3
Scope
1. Member States shall apply this Directive to any landfill as defined in Article 2(g).
2. Without prejudice to existing Community legislation, the following shall be excluded from the scope of this Directive:
- the spreading of sludges, including sewage sludges, and sludges resulting from dredging operations, and similar matter on the soil for the purposes of fertilisation or improvement,
- the use of inert waste which is suitable, in redevelopment/restoration and filling-in work, or for construction purposes, in landfills,
- the deposit of non-hazardous dredging sludges alongside small waterways from where they have been dredged out and of non-hazardous sludges in surface water including the bed and its sub soil,
- the deposit of unpolluted soil or of non-hazardous inert waste resulting from prospecting and extraction, treatment, and storage of mineral resources as well as from the operation of quarries.
3. Without prejudice to Directive 75/442/EEC Member States may declare at their own option, that the deposit of non-hazardous waste, to be defined by the committee established under Article 17 of this Directive, other than inert waste, resulting from prospecting and extraction, treatment and storage of mineral resources as well as from the operation of quarries and which are deposited in a manner preventing environmental pollution or harm to human health, can be exempted from the provisions in Annex I, points 2, 3.1, 3.2 and 3.3 of this Directive.
4. Without prejudice to Directive 75/442/EEC Member States may declare, at their own option, parts or all of Articles 6(d), 7(i), 8(a)(iv), 10, 11(1)(a), (b) and (c), 12(a) and (c), Annex I, points 3 and 4, Annex II (except point 3, level 3, and point 4) and Annex III, points 3 to 5 to this Directive not applicable to:
(a) landfill sites for non-hazardous or inert wastes with a total capacity not exceeding 15000 tonnes or with an annual intake not exceeding 1000 tonnes serving islands, where this is the only landfill on the island and where this is exclusively destined for the disposal of waste generated on that island. Once the total capacity of that landfill has been used, any new landfill site established on the island shall comply with the requirements of this Directive;
(b) landfill sites for non-hazardous or inert waste in isolated settlements if the landfill site is destined for the disposal of waste generated only by that isolated settlement.
Not later than two years after the date laid down in Article 18(1), Member States shall notify the Commission of the list of islands and isolated settlements that are exempted. The Commission shall publish the list of islands and isolated settlements.
5. Without prejudice to Directive 75/442/EEC Member States may declare, at their own option, that underground storage as defined in Article 2(f) of this Directive can be exempted from the provisions in Article 13(d) and in Annex I, point 2, except first indent, points 3 to 5 and in Annex III, points 2, 3 and 5 to this Directive.
Article 4
Classes of landfill
Each landfill shall be classified in one of the following classes:
- landfill for hazardous waste,
- landfill for non-hazardous waste,
- landfill for inert waste.
Article 5
Waste and treatment not acceptable in landfills
1. Member States shall set up a national strategy for the implementation of the reduction of biodegradable waste going to landfills, not later than two years after the date laid down in Article 18(1) and notify the Commission of this strategy. This strategy should include measures to achieve the targets set out in paragraph 2 by means of in particular, recycling, composting, biogas production or materials/energy recovery. Within 30 months of the date laid down in Article 18(1) the Commission shall provide the European Parliament and the Council with a report drawing together the national strategies.
2. This strategy shall ensure that:
(a) not later than five years after the date laid down in Article 18(1), biodegradable municipal waste going to landfills must be reduced to 75 % of the total amount (by weight) of biodegradable municipal waste produced in 1995 or the latest year before 1995 for which standardised Eurostat data is available
(b) not later than eight years afte the date laid down in Article 18(1), biodegradable municipal waste going to landfills must be reduced to 50 % of the total amount (by weight) of biodegradable municipal waste produced in 1995 or the latest year before 1995 for which stadardised Eurostat data is available;
(c) not later than 15 years after the date laid down in Article 18(1), biodegradable municipal waste going to landfills must be reduced to 35 % of the total amount (by weight) of biodegradable municipal waste produced in 1995 or the lates year before 1995 for which standardised Eurostat data is available.
Two years before the date referred to in paragraph (c) the Council shall reexamine the above target, on the basis of a report from the Commission on the practical experience gained by Member States in the pursuance of the targets laid down in paragraphs (a) and (b) accompanied, if appropriate, by a proposal with a view to confirming or amending this target in order to ensure a high level of environmental protection.
Member States which in 1995 or the latest year before 1995 for which standardised EUROSTAT data is available put more than 80 % of their collected municipal waste to landfill may postpone the attainment of the targets set out in paragraphs (a), (b), or (c) by a period not exceeding four years. Member States intending to make use of this provision shall inform in advance the Commission of their decision. The Commission shall inform other Member States and the European Parliament of these decisions.
The implementation of the provisions set out in the preceding subparagraph may in no circumstances lead to the attainment of the target set out in paragraph (c) at a date later than four years after the date set out in paragraph (c).
3. Member States shall take measures in order that the following wastes are not accepted in a landfill:
(a) liquid waste;
(b) waste which, in the conditions of landfill, is explosive, corrosive, oxidising, highly flammable or flammable, as defined in Annex III to Directive 91/689/EEC;
(c) hospital and other clinical wastes arising from medical or veterinary establishments, which are infectious as defined (property H9 in Annex III) by Directive 91/689/EEC and waste falling within category 14 (Annex I.A) of that Directive.
(d) whole used tyres from two years from the date laid down in Article 18(1), excluding tyres used as engineering material, and shredded used tyres five years from the date laid down in Article 18(1) (excluding in both instances bicylce tyres and tyres with an outside diameter above 1 400 mm);
(e) any other type of waste which does not fulfil the acceptance criteria determined in accordance with Annex II.
4. The dilution of mixture of waste solely in order to meet the waste acceptance criteria is prohibited.
Article 6
Waste to be accepted in the different classes of landfill
Member States shall take measures in order that:
(a) only waste that has been subject to treatment is landfilled. This provision may not apply to inert waste for which treatment is not technically feasible, nor to any other waste for which such treatment does not contribute to the objectives of this Directive, as set out in Article 1, by reducing the quantity of the waste or the hazards to human health or the environment;
(b) only hazardous waste that fulfils the criteria set out in accordance with Annex II is assigned to a hazardous landfill;
(c) landfill for non-hazardous waste may be used for:
(i) municipal waste;
(ii) non-hazardous waste of any other origin, which fulfil the criteria for the acceptance of waste at landfill for non-hazardous waste set out in accordance with Annex II;
(iii) stable, non-reactive hazardous wastes (e.g. solidified, vitrified), with leaching behaviour equivalent to those of the non-hazardous wastes referred to in point (ii), which fulfil the relevant acceptance criteria set out in accordance with Annex II. These hazarouds wastes shall not be deposited in cells destined for biodegradable non-hazardous waste,
(d) inert waste landfill sites shall be used only for inert waste.
Article 7
Application for a permit
Member States shall take measures in order that the application for a landfill permit must contain at least particulars of the following:
(a) the identity of the applicant and of the operator when they are different entities;
(b) the description of the types and total quantity of waste to be deposited;
(c) the proposed capacity of the disposal site;
(d) the description of the site, including its hydrogeological and geological characteristics;
(e) the proposed methods for pollution prevention and abatement;
(f) the proposed operation, monitoring and control plan;
(g) the proposed plan for the closure and after-care procedures;
(h) where an impact assessment is required under Council Directive 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment(8), the information provided by the developer in accordance with Article 5 of that Directive;
(i) the financial security by the applicant, or any other equivalent provision, as required under Article 8(a)(iv) of this Directive.
Following a successful application for a permit, this information shall be made available to the competent national and Community statistical authorities when requested for statistical purposes.
Article 8
Conditions of the permit
Member States shall take measures in order that:
(a) the competent authority does not issue a landfill permit unless it is satisfied that:
(i) without prejudice to Article 3(4) and (5), the landfill project complies with all the relevant requirements of this Directive, including the Annexes;
(ii) the management of the landfill site will be in the hands of a natural person who is technically competent to manage the site; professional and technical development and training of landfill operators and staff are provided;
(iii) the landfill shall be operated in such a manner that the necessary measures are taken to prevent accidents and limit their consequences;
(iv) adequate provisions, by way of a financial security or any other equivalent, on the basis of modalities to be decided by Member States, has been or will be made by the applicant prior to the commencement of disposal operations to ensure that the obligations (including after-care provisions) arising under the permit issued under the provisions of this Directive are discharged and that the closure procedures required by Article 13 are followed. This security or its equivalent shall be kept as long as required by maintenance and after-care operation of the site in accordance with Article 13(d). Member States may declare, at their own option, that this point does not apply to landfills for inert waste;
(b) the landfill project is in line with the relevant waste management plan or plans referred to in Article 7 of Directive 75/442/EEC;
(c) prior to the commencement of disposal operations, the competent authority shall inspect the site in order to ensure that it complies with the relevant conditions of the permit. This will not reduce in any way the responsibility of the operator under the conditions of the permit.
Article 9
Content of the permit
Specifying and supplementing the provisions set out in Article 9 of Directive 75/442/EEC and Article 9 of Directive 96/61/EC, the landfill permit shall state at least the following:
(a) the class of the landfill;
(b) the list of defined types and the total quantity of waste which are authorised to be deposited in the landfill;
(c) requirements for the landfill preparations, landfilling operations and monitoring and control procedures, including contingency plans (Annex III, point 4.B), as well as provisional requirements for the closure and after-care operations;
(d) the obligation on the applicant to report at least annually to the competent authority on the types and quantities of waste disposed of and on the results of the monitoring programme as required in Articles 12 and 13 and Annex III.
Article 10
Cost of the landfill of waste
Member States shall take measures to ensure that all of the costs involved in the setting up and operation of a landfill site, including as far as possible the cost of the financial security or its equivalent referred to in Article 8(a)(iv), and the estimated costs of the closure and after-care of the site for a period of at least 30 years shall be covered by the price to be charged by the operator for the disposal of any type of waste in that site. Subject to the requirements of Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment(9)Member States shall ensure transparency in the collection and use of any necessary cost information.
Article 11
Waste acceptance procedures
1. Member States shall take measures in order that prior to accepting the waste at the landfill site:
(a) before or at the time of delivery, or of the first in a series of deliveries, provided the type of waste remains unchanged, the holder or the operator can show, by means of the appropraite documentation, that the waste in question can be accepted at that site according to the conditions set in the permit, and that it fulfils the acceptance criteria set out in Annex II;
(b) the following reception procedures are respected by the operator:
- checking of the waste documentation, including those documents required by Article 5(3) of Directive 91/689/EEC and, where they apply, those required by Council Regulation (EEC) No 259/93 of 1 February 1993 on the supervision and control of shipments of waste within, into and out of the European Community(10);
- visual inspection of the waste at the entrance and at the point of deposit and, as appropriate, verification of conformity with the description provided in the documentation submitted by the holder. If representative samples have to be taken in order to implement Annex II, point 3, level 3, the results of the analyses shall be kept and the sampling shall be made in conformity with Annex II, point 5. These samples shall be kept at least one month;
- keeping a register of the quantities and characteristics of the waste deposited, indicating origin, date of delivery, identity of the producer or collector in the case of municipal waste, and, in the case of hazardous waste, the precise location on the site. This information shall be made available to the competent national and Community statistical authorities when requested for statistical purposes;
(c) the operator of the landfill shall always provide written acknowledgement of receipt of each delivery acepted on the site;
(d) without prejudice to the provisions of Regulation (EEC) No 259/93, if waste is not accepted at a landfill the operator shall notify without delay the competent authority of the non-acceptance of the waste.
2. For landfill sites which have been exempted from provisions of this Directive by virtue of Article 3(4) and (5), Member States shall take the necessary measures to provide for:
- regular visual inspection of the waste at the point of deposit in order to ensure that only non-hazardous waste from the island or the isolated settlement is accepted at the site; and
- a register on the quantities of waste that are deposited at the site be kept.
Member States shall ensure that information on the quantities and, where possible, the type of waste going to such exempted sites forms part of the regular reports to the Commission on the implementation of the Directive.
Article 12
Control and monitoring procedures in the operational phase
Member States shall take measures in order that control and monitoring procedures in the operational phase meet at least the following requirements:
(a) the operator of a landfill shall carry out during the operational phase a control and monitoring programme as specified in Annex III;
(b) the operator shall notify the competent authority of any significant adverse environmental effects revealed by the control and monitoring procedures and follow the decision of the competent authority on the nature and timing of the corrective measures to be taken. These measures shall be undertaken at the expense of the operator.
At a frequency to be determined by the competent authority, and in any event at least once a year, the operator shall report, on the basis of aggregated data, all monitoring results to the competent authorities for the purpose of demonstrating compliance with permit conditions and increasing the knowledge on waste behaviour in the landfills;
(c) the quality control of the analytical operations of the control and monitoring procedures and/or of the analyses referred to in Article 11(1)(b) are carried out by competent laboratories.
Article 13
Closure and after-care procedures
Member States shall take measures in order that, in accordance, where appropriate, with the permit:
(a) a landfill or part of it shall start the closure procedure:
(i) when the relevant conditions stated in the permit are met; or
(ii) under the authorisation of the competent authority, at the request of the operator; or
(iii) by reasoned decision of the competent authority;
(b) a landfill or part of it may only be considered as definitely closed after the competent authority has carried out a final on-site inspection, has assessed all the reports submitted by the operator and has communicated to the operator its approval for the closure. This shall not in any way reduce the responsibility of the operator under the conditions of the permit;
(c) after a landfill has been definitely closed, the operator shall be responsible for its maintenance, monitoring and control in the after-care phase for as long as may be required by the competent authority, taking into account the time during which the landfill could present hazards.
The operator shall notify the competent authority of any significant adverse environmental effects revealed by the control procedures and shall follow the decision of the competent authority on the nature and timing of the corrective measures to be taken;
(d) for as long as the competent authority considers that a landfill is likely to cause a hazard to the environment and without prejudice to any Community or national legislation as regards liability of the waste holder, the operator of the site shall be responsible for monitoring and analysing landfill gas and leachate from the site and the groundwater regime in the vicinity of the site in accordance with Annex III.
Article 14
Existing landfill sites
Member States shall take measures in order that landfills which have been granted a permit, or which are already in operation at the time of transposition of this Directive, may not continue to operate unless the steps outlined below are accomplished as soon as possible and within eight years after the date laid down in Article 18(1) at the latest:
(a) with a period of one year after the date laid down in Article 18(1), the operator of a landfill shall prepare and present to the competent authorities, for their approval, a conditioning plan for the site including the particulars listed in Article 8 and any corrective measures which the operator considers will be needed in order to comply with the requirements of this Directive with the exception of the requirements in Annex I, point 1;
(b) following the presentation of the conditioning plan, the competent authorities shall take a definite decision on whether operations may continue on the basis of the said conditioning plan and this Directive. Member States shall take the necessary measures to close down as soon as possible, in accordance with Article 7(g) and 13, sites which have not been granted, in accordance with Article 8, a permit to continue to operate;
(c) on the basis of the approved site-conditioning plan, the competent authority shall authorise the necessary work and shall lay down a transitional period for the completion of the plan. Any existing landfill shall comply with the requirements of this Directive with the exception of the requirements in Annex I, point 1 within eight years after the date laid down in Article 18(1);
(d) (i) within one year after the date laid down in Article 18(1), Articles 4, 5, and 11 and Annex II shall apply to landfills for hazardous waste;
(ii) within three years after the date laid down in Article 18(1), Article 6 shall apply to landfills for hazardous waste.
Article 15
Obligation to report
At intervals of three years Member States shall send to the Commission a report on the implementation of this Directive, paying particular attention to the national strategies to be set up in pursuance of Article 5. The report shall be drawn up on the basis of a questionnaire or outline drafted by the Commission in accordance with the procedure laid down in Article 6 of Directive 91/692/EEC(11) The questionnaire or outline shall be sent to Member States six months before the start of the period covered by the report. The report shall be sent to the Commission within nine months of the end of the three-year period covered by it.
The Commission shall publish a Community report on the implementation of this Directive within nine months of receiving the reports from the Member States.
Article 16
Committee
Any amendments necessary for adapting the Annexes to this Directive to scientific and technical progress and any proposals for the standardisation of control, sampling and analysis methods in relation to the landfill of waste shall be adopted by the Commission, assisted by the Committee established by Article 18 of Directive 75/442/EEC and in accordance with the procedure set out in Article 17 of this Directive. Any amendments to the Annexes shall only be made in line with the principles laid down in this Directive as expressed in the Annexes. To this end, as regards Annex II, the following shall be observed by the Committee: taking into account the general principles and general procedures for testing and acceptance criteria as set out in Annex II, specific criteria and/or test methods and associated limit values should be set for each class of landfill, including if necessary specific types of landfill within each class, including underground storage. Proposals for the standardisation of control, sampling and analysis methods in relation to the Annexes of this Directive shall be adopted by the Commission, assisted by the Committee, within two years after the entry into force of this Directive.
The Commission, assisted by the Committee, will adopt provisions for the harmonisation and regular transmission of the statistical date referred to in Articles 5, 7 and 11 of this Directive, within two years after the entry into force of this Directive, and for the amendments of such provisions when necessary.
Article 17
Committee procedure
The Commission shall be assisted by a Committee composed of the representatives of the Member States and chaired by the representative of the Commission.
The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.
Article 18
Transposition
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than two years after its entry into force. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by Member States.
2. Member States shall communicate the texts of the provisions of national law which they adopt in the field covered by this Directive to the Commission.
Article 19
Entry into force
This Directive will enter into force on the day of its publication in the Official Journal of the European Communities.
Article 20
Addressees
This Directive is addressed to the Member States.
|
[
"UKSI20021559",
"UKSI20050880",
"UKSI20041936",
"UKSI20043212",
"UKPGA20030033"
] |
31999L0036
|
1999
|
Council Directive 1999/36/EC of 29 April 1999 on transportable pressure equipment
Having regard to the Treaty establishing the European Community, and in particular Article 75(1)(c) thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 189c of the Treaty(3),
(1) Whereas within the framework of the common transport policy further measures must be adopted to ensure transport safety;
(2) Whereas each Member State currently requires all transportable equipment to be used on its territory to undergo certification and inspection, including periodic inspections, by its designated bodies; whereas this practice, requiring multiple approvals if equipment is to be used in more than one State in the course of a transport operation, constitutes an obstacle to the provision of transport services within the Community; whereas action by the Community to harmonise approval procedures is justified in order to facilitate the use of transportable pressure equipment on the territory of another Member State in the context of a transport operation;
(3) Whereas measures should be adopted for the progressive establishment of a single market in transport and, in particular, for free movement of transportable pressure equipment;
(4) Whereas action at Community level is the only possible way of achieving such harmonisation, since Member States acting independently or through international agreements cannot establish the same degree of harmonisation in the approvals for such equipment; whereas, currently, recognition of approvals given in different Member States is not satisfactory because of the element of discretion;
(5) Whereas a Council Directive is the appropriate legal instrument to enhance the safety of this equipment, as it provides a framework for uniform and compulsory application of the approval procedures by Member States;
(6) Whereas Council Directives 94/55/EC(4) and 96/49/EC(5) have extended the application of the provisions of the ADR(6) and RID(7) to cover national traffic in order to harmonise across the Community the conditions under which dangerous goods are transported by road and by rail;
(7) Whereas Directives 94/55/EC and 96/49/EC provide for the option of applying conformity assessment procedures based on modules in accordance with Decision 93/465/EEC(8) to certain new transportable pressure equipment; whereas this option should be replaced by an obligation extended to cover all new transportable pressure equipment used for the transport of dangerous goods and falling within the scope of Directives 94/55/EC and 96/49/EC;
(8) Whereas Directive 97/23/EC(9) lays down the general requirements for the free movement and safety of pressure equipment;
(9) Whereas aerosol dispensers and gas cylinders for breathing appliances should be excluded from the scope of this Directive as their free movement and safety are already covered by Directive 75/324/EEC(10) and Directive 97/23/EC;
(10) Whereas recognition of the approval certificates issued by the inspection bodies designated by the Member States' competent authorities, of the conformity assessment or reassessment procedures and of the periodic inspection procedures contributes towards removing obstacles to freedom to provide transport services; whereas such an objective cannot be achieved satisfactorily at another level by the Member States; whereas, to eliminate the element of discretion, it is necessary to establish clearly which procedures should be followed;
(11) Whereas it is necessary to lay down common rules for establishing recognition of designation inspection bodies which ensure compliance with Directives 94/55/EC and 96/49/EC; whereas these common rules will have the effect of eliminating unnecessary costs and administrative procedures related to the approval of the equipment and of eliminating technical barriers to trade;
(12) Whereas, in order not to hinder transport operations between a Member State and a third country, this Directive should not be applied to transportable pressure equipment exclusively used for transport operations of dangerous goods between the territory of the Community and that of third countries;
(13) Whereas Member States have to designate inspection bodies entitled to perform the conformity assessment or reassessment procedures and periodic inspections; whereas they must also ensure that such bodies are sufficiently independent, efficient and professionally able to carry out their appointed tasks;
(14) Whereas specific procedures should be introduced for evaluating the conformity of new valves and other accessories used for transport;
(15) Whereas provisions should be introduced regarding the reassessment of existing equipment, as defined in Annex IV, Part II; so as to enable this Directive to be applied to such equipment;
(16) Whereas compliance with the technical provisions of the Annexes to Directives 94/55/EC and 96/49/EC for new equipment must be shown by means of the conformity assessment procedures set out in Annex IV, Part I; whereas periodic inspections of existing equipment will be carried out according to the procedures set out in Annex IV, Part III;
(17) Whereas equipment referred to in this Directive should bear a mark to indicate its compliance with the requirements of Directive 94/55/EC or 96/49/EC and this Directive in order to be placed on the market, filled, used and refilled in accordance with its intended purpose;
(18) Whereas Member States must allow transportable pressure equipment bearing the mark referred to in Annex VII to move freely on their territory, to be placed on the market, to be used in the course of any transport operation or to be used in accordance with its intended purpose, without undergoing further assessment or having to comply with further technical requirements;
(19) Whereas it is appropriate that a Member State, provided it informs the Commission, should be able to take measures to limit or prohibit the placing on the market and use of equipment in cases where it presents a particular risk to safety;
(20) Whereas a committee procedure should be followed for amendment of the Annexes to this Directive and for postponing the date the Directive is brought into effect for certain transportable pressure equipment;
(21) Whereas provision should be made for transitional arrangements to enable pressure equipment, manufactured in accordance with the national rules in force before this Directive is brought into effect, to be placed on the market and put into service;
(22) Whereas Directives 84/525/EEC(11) 84/526/EEC(12) and 84/527/EEC(13) on gas cylinders provide for a conformity procedure different from that provided for by this Directive; whereas a single procedure should be established for all transportable pressure equipment;
(23) Whereas a periodic inspection procedure should be established for existing gas cylinders which are in accordance with Directives 84/525/EEC, 84/526/EEC and 84/527/EEC,
Article 1
Scope
1. The purpose of this Directive shall be to enhance safety with regard to transportable pressure equipment approved for the inland transport of dangerous goods by road and by rail and to ensure the free movement of such equipment within the Community, including the placing on the market and repeated putting into service and repeated use aspects.
2. This Directive shall apply:
(a) for the purpose of placing on the market: to new transportable pressure equipment as defined in Article 2;
(b) for the purpose of reassessment of conformity: to existing transportable pressure equipment as defined in Article 2 which meets the technical requirements laid down in Directives 94/55/EC and 96/49/EC;
(c) for repeated use and periodic inspections:
- to the transportable pressure equipment referred to in (a) and (b),
- to existing gas cylinders bearing the conformity marking laid down in Directives 84/525/EEC, 84/526/EEC and 84/527/EEC.
3. Transportable pressure equipment which was placed on the market before 1 July 2001 or, in the case of Article 18, within two years of that date and which has not been reassessed as to its conformity with the requirements of Directives 94/55/EC and 96/49/EC, shall be outside the scope of this Directive.
4. Transportable pressure equipment used exclusively for the transport of dangerous goods between Community territory and third-country territory, carried out in accordance with Article 6(1) and Article 7 of Directive 94/55/EC or Article 6(1) and Article 7(1) and (2) of Directive 96/49/EC, shall be outside the scope of this Directive.
Article 2
Definitions
For the purposes of this Directive:
1. "transportable pressure equipment" means:
- all receptacles (cylinders, tubes, pressure drums, cryogenic receptacles, bundles of cylinders as defined in Annex A to Directive 94/55/EC),
- all tanks, including demountable tanks, tank containers (mobile tanks), tanks of tank wagons, tanks or receptacles of battery vehicles or battery wagons, tanks of tank vehicles,
used for the transport of Class 2 gases in accordance with the Annexes to Directives 94/55/EC and 96/49/EC and for the transport of certain dangerous substances of other classes indicated in Annex VI to this Directive, including their valves and other accessories used for transport.
This definition excludes equipment subject to the general exemption principles applicable to small quantities and to the special cases provided for in the Annex to Directive 94/55/EC and the Annex to Directive 96/49/EC as well as aerosol dispensers (UN number 1950) and gas cylinders for breathing appliances;
2. "mark" means the symbol referred to in Article 10;
3. "conformity assessment procedures" means those procedures set out in Annex IV, Part I;
4. "reassessment of conformity" means the procedure for subsequent assessment, at the request of the owner or his authorised representative established in the Community or of the holder, of the conformity of transportable pressure equipment already manufactured and put into service before 1 July 2001 or, in the case of Article 18, within two years of that date;
5. "notified body" means an inspection body designated by the national competent authority of a Member State in accordance with Article 8 and meeting the criteria of Annexes I and II;
6. "approved body" means an inspection body designated by the national competent authority of a Member State in accordance with Article 9 and meeting the criteria of Annexes I and III.
Article 3
Conformity assessment or the placing on the Community market of new transportable pressure equipment
1. New receptacles and new tanks shall meet the relevant provisions of Directive 94/55/EC and 96/49/EC. The compliance of such transportable pressure equipment with these provisions shall be established by a notified body exclusively in accordance with the conformity assessment procedures set out in Annex IV, Part I, and specified in Annex V.
2. New valves and other accessories used for transport shall meet the relevant provisions of the Annexes to Directives 94/55/EC and 96/49/EC.
3. Valves and other accessories having a direct safety function in transportable pressure equipment, in particular safety valves, valves for filling and emptying and cylinder valves, shall be subject to a conformity assessment procedure at least a stringent as that undergone by the receptacle or tank to which they are fitted.
Such valves and other accessories used for transport may be subject to a different conformity assessment procedure separate from that used for the receptacle or tank.
4. Should Directive 94/55/EC and 96/49/EC not contain any detailed technical provisions for the valves and accessories referred to in paragraph 3, such valves and accessories must meet the requirements of Directive 97/23/EC and, pursuant to that Directive, be subject to a category II, III or IV conformity assessment procedure as laid down in Article 10 of Directive 97/23/EC according to whether the receptacle or tank belongs to category 1, 2 or 3 as laid down in Annex V to this Directive.
5. No Member State shall prohibit, restrict or impede the placing on the market or putting into service on its territory of transportable pressure equipment referred to in Article 1(2)(a) which complies with this Directive and bears the relevant mark provided for in Article 10(1) and (2).
Article 4
Conformity assessment for the placing on the national market of new transportable pressure equipment
1. By way of derogation from Article 3, Member States may authorise on their territory the placing on the market, transport and putting into service by users, of the receptacles - including their valves and other accessories used for transport - covered by Article 1(2)(a), the conformity of which has been assessed by an approved body.
2. Transportable pressure equipment the conformity of which has been assessed by an approved body may not bear the marking described in Article 10(1).
3. The approved body shall work exclusively for the group of which it is a member.
4. The procedures applicable to conformity assessment by approved bodies shall be modules A1, C1, F and G, as described in Annex IV, Part I.
5. The effects of this Article shall be monitored by the Commission and evaluated as from 1 July 2004. To this end, Member States shall forward to the Commission any useful information on the implementation of this Article. If necessary the evaluation shall be accompanied by a proposal for amendment of this Directive.
Article 5
Reassessment of conformity for existing transportable pressure equipment
1. The conformity of the transportable pressure equipment referred to in Article 1(2)(b) with the relevant provisions of the Annexes to Directives 94/55/EC and 96/49/EC shall be established by a notified body in accordance with the conformity reassessment procedure set out in Annex IV, Part II, to this Directive.
Where such equipment was manufactured in series, Member States may authorise the reassessment of conformity with regard to receptacles, including their valves and other accessories used for transport, to be carried out by an approved body provided that conformity of the type is reassessed by a notified body.
2. No Member States shall prohibit, restrict or impede the placing on the market or putting into service on its territory of transportable pressure equipment referred to in Article 1(2)(b) which complies with this Directive and bears the relevant mark provided for in Article 10(1).
Article 6
Periodic inspection and repeated use
1. Periodic inspections of the receptacles, including their valves and accessories used for transport, referred to in Article 1(2)(c) shall be arranged by a notified or approved body in accordance with the procedure set out in Annex IV, Part III. Periodic inspections of tanks, including their valves and other accessories used for transport, shall be arranged by a notified body in accordance with the procedure laid down in Annex IV, Part III, module 1.
However, Member States may permit periodic inspections of tanks carried out on their territory also to be performed by the approved bodies which have been recognised for carrying out periodic inspections of tanks and which act under the supervision of a body notified under the procedure provided for in Annex IV, Part III, Module 2 concerning periodic inspection through quality assurance.
2. The transportable pressure equipment referred to in Article 1(2) may be subjected to periodic inspection in any Member State.
3. No Member State may, on grounds concerning transportable pressure equipment as such, prohibit, restrict or impede the use (including filling, storing, emptying and refilling) on its territory of the following transportable pressure equipment:
- the equipment referred to in Article 1(2)(a) and (b) and the first indent of Article 1(2)(c), which satisfies the provisions of this Directive and bears the corresponding mark,
- existing gas cylinders bearing the conformity mark provided for in Directives 84/525/EEC, 84/526/EEC and 84/527/EEC and the mark and identification number referred to in Article 10(3) of this Directive indicating that it has undergone periodic inspection.
4. Member States may establish national requirements for the storage or use of transportable pressure equipment, but not for transportable pressure equipment itself or for the accessories needed during transport. Member States may, however, pursuant to Article 7, retain national requirements for connecting devices, colour codes and reference temperatures.
Article 7
National provisions
1. A Member State may retain its national provisions concerning devices intended for connection with other equipment and colour codes applicable to transportable pressure equipment until such time as European standards for use are added to the Annexes to Directives 94/55/EC and 96/49/EC.
However, where safety problems arise with the transport or use of certain types of gas, a short transitional period may be allowed, in accordance with the procedure laid down in Article 15, in order to enable Member States to retain their national provisions even after the European standards have been added to the Annexes to Directives 94/55/EC and 96/49/EC.
2. A Member State in which the ambient temperature is regularly lower than - 20 °C may impose more stringent standards as regards the operating temperature of material intended for use in the national transport of dangerous goods within its territory until provisions on the appropriate reference temperatures for given climatic zones are incorporated in the Annexes to Directives 94/55/EC and 96/49/EC.
Article 8
Notified bodies
1. Member States shall communicate to the Commission and the other Member States the list of notified bodies established within the Community which they have designated to carry out the new transportable pressure equipment conformity assessment procedures pursuant to Annex IV, Part I, to reassess the conformity of existing types or equipment with the requirements of the Annexes to Directives 94/55/EC and 96/49/EC pursuant to Annex IV, Part II, and/or to perform the task of periodic inspections pursuant to Annex IV, Part III, module 1 and/or to perform the task of surveillance pursuant to Annex IV, Part III, module 2. They shall also communicate the identification numbers assigned to them beforehand by the Commission.
The Commission shall publish in the Official Journal of the European Communities a list of the notified bodies, with their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.
2. Member States shall apply the criteria set out in Annexes I and II for the designation of notified bodies. Each body shall submit to the Member State which intends to designate it complete information concerning, and evidence of, compliance with the criteria in Annexes I and II.
3. A Member State which has notified a body shall withdraw such notification if it finds that the body no longer meets the criteria referred to in paragraph 2.
It shall forthwith inform the Commission and the other Member States of any such withdrawal of notification.
Article 9
Approved bodies
1. Member States shall communicate to the Commission and the other Member States the list of approved bodies established in the Community, which they have recognised in accordance with the criteria of paragraph 2, for the purpose of carrying out periodic inspections of receptacles - including their valves and other accessories used for transport - referred to in Article 2(1), first indent, or conformity reassessment of existing receptacles - including their valves and other accessories used for transport - which conform to a type reassessed by a notified body, to ensure continued compliance with the relevant provisions of Directives 94/55/EC and 96/49/EC in accordance with the procedures laid down in Annex IV, Part III, module 1. They shall also communicate the identification numbers assigned to them beforehand by the Commission.
Member States using the option provided for in Article 6(1), second subparagraph, shall also communicate to the Commission and the other Member States the list of approved bodies established in the Community, which they have recognised for the purpose of carrying out periodic inspections of tanks.
The Commission shall publish in the Official Journal of the European Communities a list of the approved bodies recognised, with their identification numbers and the tasks for which they have been recognised. The Commission shall ensure that this list is kept up to date.
2. Member States shall apply the criteria set out in Annexes I and III for the recognition of approved bodies. Each body shall submit to the Member State which intends to recognise it complete information concerning, and evidence of, compliance with the criteria in those Annexes.
3. A Member State which has recognised a body shall withdraw the approval if it finds that the body no longer meets the criteria referred to in paragraph 2.
It shall forthwith inform the Commission and the other Member States of any such withdrawal of approval.
Article 10
Marking
1. Without prejudice to the requirements for the marking of receptacles and tanks laid down in Directives 94/55/EC and 96/49/EC, receptacles and tanks satisfying the provisions of Article 3(1) and Article 5(1) shall have a mark affixed to them in accordance with Annex IV, Part I. The form of the mark to be used is set out in Annex VII. This mark shall be visibly and immovably affixed and shall be accompanied by the identification number of the notified body which has performed the conformity assessment procedure on the receptacles and tanks. In the event of reassessment, this mark shall be accompanied by the identification number of the notified or approved body.
For transportable pressure equipment complying with Article 7(2), the identification number of the notified or approved body shall be followed by "- 40 °C".
2. New valves and other accessories having a direct safety function shall bear either the mark provided for in Annex VII hereto or that provided for in Annex VI to Directive 97/23/EC. Such marks need not be accompanied by the identification number of the notified body which carried out the conformity assessment on the valves and other accessories used for transport.
The other valves and accessories shall not be subject to any special marking requirements.
3. Without prejudice to the requirements for the marking of receptacles and tanks laid down in Directives 94/55/EC and 96/49/EC, for the purposes of periodic inspections, all transportable pressure equipment referred to in Article 6(1) shall bear the identification number of the body which performed the periodic inspection of the equipment to indicate that it may continue to be used.
With regard to gas cylinders covered by Directives 84/525/EEC, 84/526/EEC and 84/527/EEC, when the first periodic inspection is carried out in accordance with this Directive, the aforementioned identification number shall be preceded by the mark described in Annex VII.
4. For both conformity assessment and reassessment and for periodic inspections, the identification number of the notified or approved body shall be visibly and immovably affixed under its responsibility either by the body itself or by the manufacturer, or his authorised representative established within the Community, or by the owner or his authorised representative established in the Community, or by the holder.
5. The affixing of markings on transportable pressure equipment which are likely to mislead third parties with regard to the meaning or the graphics of the mark referred to in this Directive shall be prohibited. Any other marking may be affixed to equipment provided that the visibility and legibility of the marking in Annex VII is not thereby reduced.
Article 11
Safeguard clause
1. Where a Member State finds that transportable pressure equipment, when correctly maintained and used for its intended purpose, is liable to endanger the health and/or safety of persons and, where appropriate, domestic animals or property, during transport and/or use, notwithstanding the fact that it bears a mark, it may restrict or prohibit the placing on the market, transport or use of the equipment in question or have it withdrawn from the market or from circulation. It shall forthwith inform the Commission of any such measure, indicating the reasons for its decision.
2. The Commission shall enter into consultation with the parties concerned without delay. Where the Commission considers, after this consultation, that the measure is justified, it shall immediately so inform the Member State which took the initiative and the other Member States.
Where the Commission considers, after this consultation, that the measure is unjustified, it shall immediately so inform the Member State which took the initiative and the owner or his authorised representative established in the Community or the holder, or the manufacturer or his authorised representative established within the Community.
3. Where transportable pressure equipment which does not comply bears the marking provided for in Article 10, the competent Member State shall take appropriate action against the person(s) who affixed the marking and shall so inform the Commission and the other Member States.
4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.
Article 12
Undue marking
Without prejudice to Article 11, where a Member State establishes that the marking described in Annex VII has been affixed unduly, the owner or his authorised representative established in the Community or the holder, or the manufacturer or his authorised representative established within the Community, shall be obliged to make the transportable pressure equipment conform as regards the provisions concerning the marking and to end the infringement under the conditions imposed by the Member State.
Should non-conformity persist, the Member State shall immediately inform the Commission othereof and take all appropriate measures to restrict or prohibit the placing on the market, transport or use of the equipment in question or to ensure that it is withdrawn from the market or from circulation in accordance with the procedure laid down in Article 11.
Article 13
Decisions leading to refusal or restriction
Any decision taken pursuant to this Directive which has the effect of restricting the placing on the market, transport or use or requires the withdrawal from the market or from circulation of transportable pressure equipment shall state the exact grounds on which it is based. Such Decision shall be notified forthwith to the party concerned, who shall at the same time be informed of the legal remedies available to him under the laws in the Member State concerned and of the time limits to which such remedies are subject.
Article 14
Committee
The amendments necessary for adapting the Annexes to this Directive shall be adopted in accordance with the procedure laid down in Article 15.
Article 15
1. Where reference is made to the procedure provided for in this Article, the Commission shall be assisted by the Committee on the transport of dangerous goods set up under Article 9 of Directive 94/55/EC, hereinafter referred to as "the Committee", composed of representatives of the Member States and chaired by a representative of the Commission.
2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If within three months of the date of referral to the Council the Council has not acted, the proposed measures shall be adopted by the Commission.
Article 16
Adoption and publication
1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive no later than 1 December 2000. They shall forthwith inform the Commission thereof.
When Member States adopt those measures they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.
Article 17
Implementation
1. Member States shall adopt no later than 1 July 2001 the provisions which they have adopted to comply with this Directive to transportable pressure equipment.
2. The date referred to in paragraph 1 shall be deferred for certain transportable pressure equipment for which there are no detailed technical specifications or for which adequate reference to the relevant European standards has not been added to the Annexes to Directives 94/55/EC and 96/49/EC.
The equipment concerned by any such deferral and the date on which this Directive becomes applicable to it shall be determined in accordance with the procedure laid down in Article 15.
Article 18
Transitional arrangements
Member States shall authorise the placing on the market and putting into service of transportable pressure equipment which complies with the regulations in force within their territory before 1 July 2001 until 24 months from that date and shall authorise the subsequent putting into service of such equipment placed on the market prior to that date.
Article 19
Penalties
Member States shall lay down a system of penalties for breaches of the national provisions adopted pursuant to this Directive and shall take all the measures necessary to ensure that those penalties are applied. The penalties thus provided for shall be effective, proportionate and dissuasive.
Member States shall notify the relevant provisions to the Commission not later than 1 December 2000 and shall inform it of any subsequent changes as soon as possible.
Article 20
Applicability of provisions of other Directives
As from 1 July 2001 or, in the case of Article 18, within two years of the date, the only provisions of Directives 84/525/EEC, 84/526/EEC and 84/527/EEC to remain applicable shall be those of Article 1 and those of Annex I, Parts 1 to 3, of each of those Directives.
The provisions of Directive 76/767/EEC(14) shall no longer apply from 1 July 2001 or, in the case of Article 18, within two years of that date, for transportable pressure equipment falling within the scope of this Directive.
However, EEC pattern approval certificates for cylinders, issued pursuant to Directives 84/525/EEC, 84/526/EEC and 84/527/EEC shall be recognised as equivalent to the EC type-examination certificates provided for in this Directive.
Article 21
This Directive shall enter into fore on the day of its publication on the Official Journal of the European Communities.
Article 22
This Directive is addressed to the Member States.
|
[
"UKSI19992001",
"UKSI20011426"
] |
31999L0035
|
1999
|
Council Directive 1999/35/EC of 29 April 1999 on a system of mandatory surveys for the safe operation of regular ro-ro ferry and high-speed passenger craft services
Having regard to the Treaty establishing the European Community, and in particular Article 84(2),
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure referred to in Article 189c of the Treaty(3),
(1) Whereas within the framework of the common transport policy further measures must be taken to improve safety in the maritime transport of passengers;
(2) Whereas the Community is seriously concerned by shipping accidents involving ro-ro ferries which have resulted in a massive loss of life; whereas persons using ro-ro ferries and high-speed passenger craft throughout the Community have the right to expect and to be able to rely on an appropriate level of safety;
(3) Whereas the Council invited the Commission, in its resolution of 22 December 1994 on the safety of roll-on/roll-off passenger ferries(4), to submit proposals for a mandatory survey and control regime for the safety of all ro-ro passenger ferries operating to or from ports of the Community, including the right of investigation of marine casualties;
(4) Whereas in view, in particular, of the internal market dimension of maritime passenger transport, action at Community level is the most effective way of establishing a common minimum level of safety for ships throughout the Community;
(5) Whereas action at Community level is the best way to ensure the harmonised enforcement of some principles agreed on within the International Maritime Organisation (IMO), thus avoiding distortions of competition between different Community ports and ro-ro ferries and high-speed passenger craft;
(6) Whereas, in view of the proportionality principle, a Council Directive is the appropriate legal instrument as it provides a framework for the Member States' uniform and compulsory application of the common safety standards, while leaving each Member State the right to decide which implementation tools best fit its internal system;
(7) Whereas the safety of ships is primarily the responsibility of flag States; whereas each Member State should ensure compliance with the safety requirements applicable to the ro-ro ferries and high speed passenger craft flying the flag of that Member State and to the companies that operate them;
(8) Whereas port State control does not provide for regular in-depth preventive surveys and verifications for ro-ro ferries and high speed passenger craft; whereas it therefore should be verified that companies and their ferries and craft comply with the safety standards agreed within the IMO and, where appropriate, at regional level, through a system of regular mandatory inspections by host States; whereas companies should be prevented from operating such ferries and craft if these inspections reveal dangerous non-conformity with these safety standards;
(9) Whereas this Directive addresses the Member States in their capacity as host States; whereas the responsibilities exercised in that capacity are based on specific port State responsibilities that are fully in line with the 1982 United Nations Convention on the Law of the Sea (Unclos);
(10) Whereas in the interest of improving safety and avoiding distortion of competition, the common safety standards should apply to all ro-ro ferries and high-speed passenger craft, regardless of the flag they fly, providing regular services to or from a port in the Member States both on international voyages and on domestic voyages in sea areas beyond 20 miles from a coast line where shipwrecked persons can land, while leaving the possibility to the Member States to extend the scope of application of the Directive to ro-ro ferries and high-speed passenger craft operating on domestic voyages in sea areas within 20 miles from a coast line;
(11) Whereas it is necessary that host States check whether the ro-ro ferries and high-speed passenger craft operating to and from Community ports conform to certain harmonised requirements for certification and survey by the flag State;
(12) Whereas those ro-ro ferries and high-speed passenger craft should also conform, at the building stage and during their entire lifetime, with the applicable classification standards as regards the construction and maintenance of their hull, main and auxiliary machinery, electrical installation and control installation and should be fitted with a voyage data recorder complying with the relevant international requirements;
(13) Whereas host States should check that the companies providing those services operate their ro-ro ferries and high-speed passenger craft so as to guarantee maximum safety; whereas interested Member States, other than the flag State, should be allowed to participate fully in any investigation of a marine casualty;
(14) Whereas it is fundamental to check that third flag State administrations concur with the companies' commitments to cooperate with any investigation of a marine casualty or incident and to comply with the rules of recognised organisations for classification and, where applicable, for certification; whereas such administrations should accept the use of harmonised survey and certification procedures;
(15) Whereas, in order to ensure continuous compliance of ro-ro ferries and high-speed passenger craft with the requirements of this Directive, host States should carry out surveys prior to the start of a service and thereafter at regular intervals and whenever a significant change occurs in the operating circumstances;
(16) Whereas in order to reduce the burden placed on companies, due account should be taken of previous verifications and surveys; ro-ro ferries and high-speed passenger craft should be exempted from surveys where it has been confirmed that they comply with this Directive for operation on similar routes and replacement ferries and craft should benefit from special arrangements; whereas ro-ro ferries and high-speed passenger craft which have been surveyed to the satisfaction of the host State should not be subjected to expanded inspections under Council Directive 95/21/EC of 19 June 1995 concerning the enforcement, in respect of shipping using Community ports and sailing in the waters under the jurisdiction of the Member States, of international standards for ship safety, pollution prevention and shipboard living and working conditions (port State control)(5);
(17) Whereas Member States should cooperate to exercise their responsibilities as host States;
(18) Whereas Member States might find it useful to be assisted in the performance of their tasks by recognised organisations which meet the requirements of Council Directive 94/57/EC of 22 November 1994 on common rules and standards for ship inspection and survey organisations and for the relevant activities of marine administrations(6);
(19) Whereas due account should be taken, in planning the surveys, of the operational and maintenance schedules of the ro-ro ferries and high-speed passenger craft;
(20) Whereas Member States should ensure that their internal legal systems enable them and any other substantially interested Member States to participate or cooperate in, or conduct, accident investigations on the basis of the provisions of the IMO Code for the investigation of marine casualties; whereas the outcome of such investigations should be made publicly available;
(21) Whereas a set of accompanying measures in the areas of navigational guidance systems, contingency planning and local operational restrictions will further improve safety;
(22) Whereas, in order to enable the monitoring of the application of this Directive, a database should be established based on the information derived from the surveys;
(23) Whereas it is necessary for a committee consisting of representatives of the Member States to assist the Commission in the effective application of this Directive; whereas the Committee set up in Article 12 of Council Directive 93/75/EEC of 13 September 1993 concerning minimum requirements for vessels bound for or leaving Community ports and carrying dangerous or polluting goods(7), can undertake that function;
(24) Whereas certain provisions of the Directive may be adapted by that Committee to bring them into line with Community or IMO measures and to improve its regime to take into account future amendments to the 1974 International Convention for the Safety of Life at Sea (SOLAS) which have entered into force and to ensure a harmonised implementation of amendments to some IMO resolutions without broadening its scope,
Article 1
Purpose
The purpose of this Directive is to lay down a system of mandatory surveys which will provide a greater assurance of safe operation of regular ro-ro ferries and high-speed passenger craft services to or from ports in the Member States of the Community and to provide for the right of Member States to conduct, participate in or cooperate with any investigation of maritime casualties or incidents on these services.
Article 2
Definitions
For the purpose of this Directive and its Annexes,
(a) "ro-ro ferry" shall mean a seagoing passenger vessel with facilities to enable road or rail vehicles to roll on and roll off the vessel, and carrying more than 12 passengers;
(b) "high-speed passenger craft" shall mean a high-speed craft as defined in Regulation 1 of Chapter X of the 1974 SOLAS Convention, as amended on the date of the adoption of this Directive, which carries more than 12 passengers;
(c) "a passenger" is every person other than:
(i) the master and the members of the crew or other persons employed or engaged in any capacity on board a ship on the business of that ship, and
(ii) a child under one year of age;
(d) "1974 SOLAS Convention" shall mean the International Convention for the Safety Of Life At Sea, together with Protocols and amendments thereto, in force on the date of adoption of this Directive;
(e) "High-speed Craft Code" shall mean the "International Code for Safety of High-speed Craft" contained in IMO Maritime Safety Committee Resolution MSC 36 (63) of 20 May 1994, as amended on the date of the adoption of this Directive;
(f) "regular service" shall mean a series of ro-ro ferry or high-speed passenger craft crossings operated so as to serve traffic between the same two or more ports, or a series of voyages from and to the same port without intermediate calls, either:
(i) according to a published timetable; or
(ii) with crossings so regular or frequent that they constitute a recognisable systematic series;
(g) "sea area" shall mean any sea area included in a list established in accordance with Article 4 of Council Directive 98/18/EC of 17 March 1998 on safety rules and standards for passenger ships(8);
(h) "certificates" shall mean:
(i) for ro-ro ferries and high-speed passenger craft engaged on international voyages, the safety certificates issued under the 1974 SOLAS Convention as amended, together with the relevant records of equipment and where appropriate exemption certificates and permits to operate;
(ii) for ro-ro ferries and high-speed passenger craft engaged on domestic voyages, the safety certificates issued in accordance with Directive 98/18/EC together with the relevant records of equipment and where appropriate exemption certificates and permits to operate;
(i) "exemption certificate" shall mean any certificate issued under the provisions of Regulation I B/12(a)(vi) of the 1974 SOLAS Convention;
(j) "administration of the flag State" shall mean the competent authorities of the State whose flag the ro-ro ferry or the high-speed passenger craft is entitled to fly;
(k) "host State" shall mean a Member State to or from whose port(s) a ro-ro ferry or a high-speed passenger craft is engaged on a regular service;
(l) "international voyage" shall mean a voyage by sea from a port of a Member State to a port outside that Member State, or conversely;
(m) "domestic voyage" shall mean a voyage in sea areas from a port of a Member State to the same or another port within that Member State;
(n) "recognised organisation" shall mean an organisation recognised in accordance with Article 4 of Directive 94/57/EC;
(o) "company" shall mean a company operating one or more ro-ro ferries to which a document of compliance has been issued in compliance with Article 5(2) of Council Regulation (EC) No 3051/95 of 8 December 1995 on the safety management of roll on/roll off passenger ferries (ro-ro ferries)(9) or a company operating high-speed passenger craft, to which a document of compliance has been issued in accordance with Regulation IX/4 of the 1974 SOLAS Convention, as amended on the date of adoption of this Directive;
(p) "Code for the investigation of marine casualties" shall mean the Code for the investigation of marine casualties and incidents adopted by the IMO by means of Assembly Resolution A.849(20) of 27 November 1997;
(q) "specific survey" shall mean a survey by the host State as specified in Articles 6 and 8;
(r) "qualified inspector" shall mean a public-sector employee or other person, duly authorised by the competent authority of a Member State to carry out surveys and inspections related to the certificates and fulfilling the criteria of qualification and independence specified in Annex V;
(s) "deficiency" shall mean a condition found not to be in compliance with the requirements of this Directive.
Article 3
Scope
1. This Directive shall apply to all ro-ro ferries and high-speed passenger craft operating to or from a port of a Member State on a regular service, regardless of their flag, when engaged on international voyages or on domestic voyages in sea areas covered by Class A as referred to in Article 4 of Directive 98/18/EC.
2. Member States may apply this Directive to ro-ro ferries and high-speed passenger craft engaged on domestic voyages in sea areas other than those referred to in paragraph 1. In those circumstances the relevant rules shall be applied to all ro-ro ferries or high-speed passenger craft operating under the same conditions, without discrimination in respect of flag, nationality or place of establishment of the company.
Article 4
Initial verifications required in relation to ro-ro ferries and high-speed passenger craft
1. Prior to the start of operation by a ro-ro ferry or high-speed passenger craft on a regular service, or within 12 months of the date referred to in Article 19(1) for a ro-ro ferry or high-speed passenger craft already operating a regular service on that date, host States shall check that ro-ro ferries and high-speed passenger craft:
(a) carry valid certificates, issued by the administration of the flag State or by a recognised organisation acting on its behalf;
(b) have been surveyed for the issue of certificates in accordance with the relevant procedures and guidelines annexed to IMO Assembly Resolution A.746(18) on survey guidelines under the harmonised system of survey and certification, as they stand at the time of adoption of this Directive or with procedures designed to achieve the same goal;
(c) comply with the standards specified for classification by the rules of a recognised organisation, or rules accepted as equivalent by the administration of the flag State for construction and maintenance of their hull, machinery and electrical and control installation;
(d) are fitted with a voyage data recorder (VDR) for the purpose of providing information for the benefit of a possible casualty investigation. The VDR shall meet the performance standards of IMO Assembly Resolution A.861(20) of 27 November 1997 and comply with the testing standards laid down in International Electrotechnical Commission (IEC) standard No 61996. However, for VDRs to be placed on board ro-ro ferries and high-speed passenger craft built before the entry into force of this Directive, exemptions for compliance with some of the requirements may be granted. These exemptions and the conditions under which they can be granted shall be adopted in accordance with the procedure laid down in Article 16;
(e) comply with specific stability requirements adopted at regional level, and transposed into their national legislation in accordance with the notification procedure laid down in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services(10), when operating in that region a service covered by that national legislation, provided those requirements do not exceed those specified in the Annex on Resolution 14 (Stability Requirements Pertaining to the Agreement) of the 1995 SOLAS Conference and have been notified to the Secretary-General of the IMO, in accordance with the procedures specified in point 3 of that resolution.
2. Paragraph 1(e) shall apply to high speed passenger craft only where appropriate.
Article 5
Initial verifications required in relation to companies and flag States
Prior to the start of operation by a ro-ro ferry or high-speed passenger craft on a regular service, or within 12 months of the date referred to in Article 19(1) for a ro-ro ferry or high-speed passenger craft already operating on a regular service on that date, host States shall:
1. check that companies which operate or intend to operate such a ferry or craft on regular service:
(a) take the necessary measures to ensure that the specific requirements laid down in Annex I are applied and provide the evidence of compliance with this paragraph and with Article 4 to the host States involved in the regular service;
(b) will agree in advance that host States and any substantially interested Member State may conduct, participate fully in or cooperate with any investigation of a marine casualty or incident in accordance with Article 12, and will give them access to the information retrieved from the VDR of their ferry or craft involved in such a casualty or incident.
2. Check for such a ferry or craft flying a flag other than that of a Member State, the concurrence of that flag State that it has accepted the company's commitment to meet the requirements of this Directive.
Article 6
Initial specific surveys
1. Prior to the start of operation by a ro-ro ferry or high-speed passenger craft on a regular service, or within 12 months of the date referred to in Article 19(1) for a ro-ro ferry and high-speed passenger craft already operating a regular service on that date, host States shall carry out an initial specific survey, in accordance with Annexes I and III, to satisfy themselves that the ro-ro ferry or high-speed passenger craft fulfils the necessary requirements for safe operation of a regular service.
2. Where this Article is applied prior to the start of operation, host States shall set a date for the initial specific survey which is no more than one month after receipt of the evidence necessary to complete the verification under Articles 4 and 5.
Article 7
Special provisions
1. When a ro-ro ferry or high-speed passenger craft is to be engaged on another regular service, a new host State shall take the utmost account of verifications and surveys previously carried out for that ferry or craft for operation on a previous regular service covered by this Directive. Provided that the new host State is satisfied with these previous verifications and surveys and that they are relevant to the new operational conditions, Articles 4, 5 and 6 need not be applied prior to the ro-ro ferry or high-speed passenger craft starting operation on the new regular service.
2. Articles 4, 5 and 6 need not apply when a ro-ro ferry or high-speed passenger craft which complies with this Directive already operating a regular service covered by this Directive transfers to another regular service covered by this Directive transfers to another regular service where the route characteristics are agreed by the relevant host States to be similar, and the host States all agree that the ro-ro ferry or high-speed passenger craft fulfils all the requirements for safe operation on that service.
At the request of a company, the host States concerned may confirm in advance their agreement as to where route characteristics are similar.
3. In cases where, following unforeseen circumstances, a replacement ro-ro ferry or high-speed passenger craft must be introduced rapidly to ensure continuity of service, and paragraphs 1 and 2 are not applicable, the host State may allow the ferry or craft to start operating provided that:
(a) a visual inspection and document check raise no concerns that the ro-ro ferry or high-speed passenger craft does not fulfil the necessary requirements for safe operation, and
(b) the host State completes the verifications and surveys under Articles 4, 5 and 6 within one month.
Article 8
Regular specific surveys and other surveys
1. Host States shall, once in every 12-month period, carry out:
- a specific survey, in accordance with Annex III, and
- a survey during a regular service, which shall aim to cover enough items listed in Annexes I, III and IV in order to satisfy the host State that the ferry or craft continues to fulfil all the necessary requirements for safe operation.
An initial specific survey in accordance with Article 6 counts as a specific survey for the purposes of this Article.
2. A host State shall carry out a specific survey in accordance with Annex III each time the ro-ro ferry or high-speed passenger craft undergoes repairs, alterations and modifications of a major character, or when there is a change in management or flag, or a transfer of class. However, in case of change in management or flag, or transfer of class, the host State may, after taking account of verifications and surveys previously issued for the ferry or craft, and provided that the safe operation of the ferry or craft is not affected by this change or transfer, dispense the ferry or craft from the specific survey required by this paragraph.
3. Should the surveys referred to in paragraph 1 confirm or reveal deficiencies in relation to the requirements of this Directive warranting a prevention of operation, all costs relating to the surveys in any normal accounting period shall be covered by the company.
Article 9
Notification
Host States shall inform companies promptly, in writing, of the outcome of verifications and surveys under Articles 4, 5, 6 and 8.
Article 10
Prevention of operation
1. A host State shall prevent the operation of a ro-ro ferry or high-speed passenger craft on a regular service:
(a) when it has been unable to confirm compliance with the requirements in Articles 4 and 5;
(b) whenever deficiencies are found during the surveys referred to in Articles 6 and 8 which pose an immediate danger to life, the ferry or craft, its crew and passengers;
(c) when there is an established failure to comply with the Community instruments listed in Annex II which poses an immediate danger of life, the ferry or craft, its crew and passengers;
(d) whenever it has not been consulted by the flag State on the matters referred to in Article 13(1) or (5),
until the host State has established that the danger has been removed and the requirements of the Directive are met.
The host State shall inform the company in writing of the decision to prevent that ro-ro ferry or high-speed passenger craft operating, giving full reasoning.
2. However, where the ro-ro ferry or high-speed passenger craft is already operating a regular service and deficiencies are established, host States shall require the company to take the necessary measures for their prompt rectification or within a well-defined and reasonable period of time, provided they do not pose an immediate danger to the safety of the ferry or craft, its crew and passengers. After rectification of the deficiencies, the host States concerned shall verify that the rectification has been carried out to their full satisfaction. If this is not the case, they shall prevent the ferry or craft from operating.
3. Member States shall, in accordance with national legislation, establish and maintain appropriate procedures covering the right of appeal by a company against a decision to prevent operation. Appeals should be dealt with expeditiously. An appeal shall not cause the decision to be automatically suspended.
The competent authority shall duly inform the company of its right of appeal.
4. In cases where Articles 4, 5 and 6 are applied prior to the start of operation by a ro-ro ferry or high-speed passenger craft on a regular service, a decision to prevent a ship operating must be taken within one month of the initial specific survey and communicated to the company immediately.
Article 11
Procedures related to initial and regular specific surveys
1. Ro-ro ferries and high-speed passenger craft that have been subject to the specific surveys to the satisfaction of the involved host State(s) shall be exempted by these host State(s) from expanded inspections referred to in Article 7(4) of Directive 95/21/EC and from expanded inspections based on the clear grounds that they belong to the category of passenger ships referred to in Article 7(1) and Annex V.A.3 of that Directive.
2. Administrations of two or more host States involved in a specific survey of the same ship or craft shall cooperate with each other. The specific surveys shall be carried out by a team composed of qualified inspectors of the involved host State(s). Wherever there is a need for qualitative assessment of the fulfilment of class-related provisions, host States shall ensure the necessary expertise is included in the team, where appropriate by including a surveyor of a recognised organisation. The inspectors shall report deficiencies to the administrations of the host States. The host State shall communicate this information to the flag State, if that State is not a host State involved in the survey.
3. An involved host State may agree to carry out a survey at the request of another involved host State.
4. Host States, when requested by companies, shall invite the administration of the flag State which is not a host State to be represented in any specific survey under the provisions of this Directive.
5. Host States, in planning a survey in accordance with Articles 6 and 8, shall take due account of the operational and maintenance schedule of the ferry or craft.
6. The findings of the specific surveys shall be recorded in a report of which the format shall be established in accordance with the procedure laid down in Article 16.
7. In case of persistent disagreement between host States on the fulfilment of the requirements of Articles 4 and 5(1), the administration of any host State involved in a specific survey shall immediately notify to the Commission the reasons of the disagreement.
8. The Commission shall immediately start proceedings in order to take a decision in accordance with the procedure laid down in Article 16.
Article 12
Accident investigation
1. Member States shall define, in the framework of their respective internal legal systems, a legal status that will enable them and any other substantially interested Member State to participate, to cooperate in, or where provided for under the Code for the investigation of marine casualties, to conduct any marine casualty or incident investigation involving a ro-ro ferry or high-speed passenger craft.
2. "Substantially interested State", "lead investigating State" and "marine casualty" shall have the same meaning as in the Code for the investigation of marine casualties.
3. When a ro-ro ferry or high-speed passenger craft is involved in a marine casualty, the investigation procedure shall be launched by the State in whose waters the accident or incident occurs or, if in other waters, by the last Member State visited by the ferry or craft. This State shall remain responsible for the investigation and coordination with other substantially interested States until such time as it is mutually agreed which is to be the lead investigating State.
4. Member States conducting, participating in or cooperating with such investigations shall ensure that the investigation is concluded in the most efficient way and within the shortest possible time taking into account the Code for the investigation of marine casualties.
5. Member States shall ensure that reports resulting from such an investigation are made public in accordance with point 12.3 of the Code for the investigation of marine casualties and notified to the Commission.
Article 13
Accompanying measures
1. Member States issuing or recognising an exemption certificate shall work together with the involved host State or administration of the flag State to resolve any disagreement concerning the suitability of the exemptions prior to the initial specific survey.
2. Member States should operate shore-based navigational guidance systems and other information schemes in accordance with IMO Resolution A.795(19) to assist ro-ro ferries and high-speed passenger craft in the safe conduct of the regular service, or part of it, for the safety of which they bear responsibility.
3. Each Member State shall provide to the Commission copies of the survey reports referred to in Article 11(6), with the IMO identification number where applicable. The Commission may, in accordance with the procedure laid down in Article 16, decide on appropriate means for allocating an identification number to other vessels. If two or more host States are involved in the regular service, the data may be provided by one of these host States. The Commission shall set up and maintain a database containing the information provided. Conditions of access to the database shall be decided in accordance with the procedure laid down in Article 16.
4. Member States shall ensure that companies operating ro-ro ferries or high-speed passenger craft on regular services to or from their ports are able to maintain and implement an integrated system of contingency planning for shipboard emergencies. To this end they shall make use of the framework provided by IMO Assembly Resolution A.852(20) on guidelines for a structure of an integrated system of contingency. If two or more Member States are involved as host States in the regular service they shall jointly establish a plan for the different routes.
5. Member States shall ensure that they have been fully involved in their capacity as host State by the administration of the flag State, before the issuance of the permit to operate high speed craft, in accordance with the provisions of paragraph 1.9.3 of the High-speed Craft Code. They shall ensure that operational restrictions required by local situations, necessary to protect life, natural resources and coastal activities are established or maintained and they shall take measures to ensure the enforcement of these restrictions.
Article 14
Cooperation between host States
Host States involved in the same regular service shall liaise with each other when applying this Directive.
Article 15
Supporting measures
The Member States shall inform third States which have either flag State responsibilities or responsibilities similar to those of a host State for ro-ro ferries and high-speed passenger craft falling under the scope of this Directive and operating between a port of a Member State and a port of a third State of the requirements imposed by this Directive on any company providing a regular service to or from a port of the Community.
Article 16
Regulatory committee
1. The Commission shall be assisted by the committee set up under Article 12(1) of Directive 93/75/EEC.
2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.
(b) If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of eight weeks from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.
Article 17
Amendment procedure
In accordance with the procedure laid down in Article 16:
(a) the Annexes,
(b) the definitions,
(c) references to Community instruments,
(d) references to IMO resolutions,
may be amended to the extent necessary to bring them into line with Community or IMO measures which have entered into force, but without broadening the scope of this Directive.
The Annexes may also be amended in accordance with the procedure laid down in Article 16 when it is necessary to improve the arrangements established by this Directive, but without broadening its scope.
Article 18
Penalties
Member States shall lay down the system of penalties for breaching the national provisions adopted pursuant to this Directive and shall take all the measures necessary to ensure that those penalties are applied. The penalties thus provided for shall be effective, proportionate and dissuasive.
Article 19
Application
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 December 2000 and forthwith inform the Commission thereof.
2. The provisions of Article 4(1)(d) shall be applied no later than 30 months after the publication date of IEC standard No 61996 or by 1 January 2001, whichever of these dates comes later.
3. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
4. The Member States shall immediately notify to the Commission all provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof.
Article 20
Assessment of application
Three years after the date referred to in Article 19(1), the Commission shall assess, on the basis of information to be provided by the Member States in accordance with Article 13, the application of this Directive.
Article 21
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 22
Adressees
This Directive is addressed to the Member States.
|
[
"UKSI20010152"
] |
31999L0037
|
1999
|
Council Directive 1999/37/EC of 29 April 1999 on the registration documents for vehicles
Having regard to the Treaty establishing the European Community, and in particular Article 75(1)(d) thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 189c of the Treaty,(3),
(1) Whereas the Community has adopted a certain number of measures that are intended to create an internal market consisting of an area without frontiers within which the free movement of goods, persons, services and capital is guaranteed in accordance with the provisions of the Treaty;
(2) Whereas all of the Member States require the driver of a vehicle registered in another Member State of hold the certificate of registration corresponding to that vehicle, in order for it to be permitted to use the roads on their territory;
(3) Whereas harmonisation of the form and content of the registration certificate will facilitate its comprehension and thus help towards the free movement, on the roads in the territory of the other Member States, of vehicles registered in a Member State;
(4) Whereas the content of the registration certificate must enable it to be checked that the holder of a driving licence issued pursuant to Council Directive 91/439/EEC of 29 July 1991 on driving licences(4) drives solely those categories of vehicles for which he is authorised; whereas such checking helps to improve road safety;
(5) Whereas, as a prerequisite for registering a vehicle that has previously been registered in another Member State, all of the Member States require a document certifying that registration and the technical characteristics of the vehicle;
(6) Whereas harmonisation of the registration certificate will facilitate the re-entry into service of vehicles that have previously been registered in another Member State, and will contribute to the proper functioning of the internal market;
(7) Whereas Member States use a registration certificate consisting either of one single part or two separate parts, and whereas it is currently appropriate to allow both systems to coexist;
(8) Whereas differences remain between the Member States concerning the interpretation of the particulars contained in the registration certificate; whereas, in the interests of the proper functioning of the internal market and of the free movement and checks that these involve, it is therefore appropriate to specify in which capacity the persons named in the certificate may use the vehicle for which it was issued;
(9) Whereas, in order to facilitate those checks specifically intended to combat fraud and the illegal trade in stolen vehicles, it is appropriate to establish close cooperation between Member States, based on an effective exchange of information;
(10) Whereas it is appropriate to provide for a simplified procedure for adjusting the technical aspects contained in Annexes I and II
Article 1
This Directive shall apply to the documents issued by the Member States at the time of registration of vehicles.
It shall not prejudice the right of Member States to use, for the temporary registration of vehicles, documents which may not meet the requirements of this Directive in every respect.
Article 2
For the purposes of this Directive:
(a) "vehicle": shall mean any vehicle as defined in Article 2 of Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers(5) and in Article 1 of Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two or three-wheel motor vehicles(6);
(b) "registration": shall mean the administrative authorisation for the entry into service in road traffic of a vehicle, involving the identification of the latter and the issuing to it of a serial number, to be known as the registration number;
(c) "registration certificate": shall mean the document which certifies that the vehicle is registered in a Member State;
(d) "holder of the registration certificate": shall mean the person in whose name a vehicle is registered.
Article 3
1. Member States shall issue a registration certificate for vehicles which are subject to registration under their national legislation. The certificate shall consist of either a single part in accordance with Annex I or two parts in accordance with Annexes I and II.
Member States may authorise the services they appoint to this end, in particular those of the manufacturers, to fill in the technical parts of the registration certificate.
2. Where a new registration certificate is issued for a vehicle registered prior to the implementation of this Directive, Member States shall use a certification model as defined in this Directive and may limit the particulars shown therein to those for which the required data are available.
3. The data given in the registration certificate, in accordance with Annexes I and II, shall be represented by the harmonised Community codes shown in those Annexes.
Article 4
For the purposes of this Directive, the registration certificate issued by a Member State shall be recognised by the other Member States for the identification of the vehicle in international traffic or for its re-registration in another Member State.
Article 5
1. For the purposes of identifying a vehicle in road traffic, Member States may require that the driver carry Part I of the registration certificate.
2. With a view to re-registering a vehicle previously registered in another Member State, the competent authorities shall require the submission of Part I of the previous registration certificate in every case and the submission of Part II if it was issued. These authorities shall withdraw the part(s) of the previous registration certificate submitted and shall keep the latter for a minimum of six months. They shall, within two months, inform the authorities of the Member State which delivered the certificate of its withdrawal. They shall return the certificate which they have withdrawn to those authorities if they so request within six months of its withdrawal.
Where the registration certificate consists of Parts I and II, and Part II is missing, the competent authorities in the Member State where the new registration has been requested may decide, in exceptional cases, to re-register the vehicle, but only after having obtained confirmation, in writing or by electronic means, from the competent authorities in the Member State where the vehicle was previously registered, that the applicant is entitled to re-register the vehicle in another Member State.
Article 6
Any amendments necessary in order to adapt the Annexes to this Directive to technical progress shall be adopted in accordance with the procedure laid down in Article 7.
Article 7
1. Where reference is made to the procedure provided for in this Article, the Commission shall be assisted by the committee established by Article 8 of Council Directive 96/96/EC of 20 December 1996 on the approximation of the laws of the Member States relating to roadworthiness tests for motor vehicles and their trailers(7), hereinafter referred to as the "committee", which shall consist of representatives of the Member States with a representative of the Commission in the chair.
2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.
(b) If the measures envisaged are not accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, within three months of the submission of the proposal to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.
Article 8
1. Member States shall bring into force the laws, regulations or administration provisions necessary to comply with this Directive by 1 June 2004. They shall notify the Commission thereof immediately.
When Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such reference at the time of their official publication. The methods of making such reference shall be laid down by Member States.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive.
The Commission shall communicate to the Member States all the models for registration certificates used by the national administration.
Article 9
Member States shall assist one another in the implementation of this Directive. They may exchange information at bilateral or multilateral level in particular so as to check, before any registration of a vehicle, the latter's legal status, where necessary in the Member State in which it was previously registered. Such checking may in particular involve the use of an electronic network.
Article 10
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 11
This Directive is addressed to the Member States.
|
[
"UKSI20033073"
] |
31999L0039
|
1999
|
Commission directive 1999/39/EC of 6 May 1999 amending Directive 96/5/EC on processed cereal-based foods and baby foods for infants and young children (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs for particular nutritional uses(1), as amended by Directive 96/84/EC of the European Parliament and of the Council(2), and in particular Article 4(1) thereof,
After consulting the Scientific Committee for Food,
(1) Whereas Article 6 of Commission Directive 96/5/EC(3), as amended by Directive 98/36/EC(4), provides that processed cereal-based foods and baby foods shall not contain any substance in such quantity as to endanger the health of infants and young children and that necessary maximum levels for such substances shall be established without delay;
(2) Whereas different regulations on the maximum levels of pesticide residues in processed cereal-based foods and baby foods cause trade barriers between certain Member States;
(3) Whereas maximum levels for pesticide residues stipulated in Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables(5), as last amended by Directive 97/41/EC(6), in Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(7), as last amended by Directive 98/82/EC(8), in Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin(9), as last amended by Directive 98/82/EC, and in Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables(10), as last amended by Directive 98/82/EC, are without prejudice to specific provisions applicable to processed cereal-based foods and baby foods;
(4) Whereas, taking into account the Community's international obligations, in cases where the relevant scientific evidence is insufficient, the precautionary principle allows the Community to provisionally adopt measures on the basis of available pertinent information, pending an additional assessment of risk and a review of the measure within a reasonable period of time;
(5) Whereas on the basis of the two opinions given by the Scientific Committee for Food on 19 September 1997 and 4 June 1998 there are at presents doubts as to the adequacy of existing acceptable daily intake values (ADI) for the protection of the health of infants and young children; whereas the doubts expressed concern not only pesticides and pesticide residues, but also dangerous chemical substances, and consequently the Commission will examine the possibility of fixing, as soon as possible, maximum levels for heavy metals in foods intended for infants and young children;
(6) Whereas, therefore, as far as foods for particular nutritional uses intended for infants and young children are concerned, it is appropriate to adopt a very low common limit for all pesticides pending case-by-case scientific screening and evaluation of substances;
(7) Whereas this very low common limit should be fixed at 0,01 mg/kg which is in practice the minimum detectable level;
(8) Whereas the Commission in cooperation with interesed parties will endeavour to complete the review without delay and to fix the appropriate and scientifically justified levels to be incorporated in a new Annex VII;
(9) Whereas severe limitations on pesticide residues should be required; whereas, with careful selection of raw materials, and given that processed cereal-based foods and baby foods undergo extensive processing during their manufacture, it is feasible to produce products containing very low levels of pesticide residues;
(10) Whereas, however, for a small number of pesticides even such low levels might allow the possibility that under worst-case intake conditions the ADI of these pesticides is exceeded; whereas, therefore, processed cereal-based foods and baby foods should be free of those particular pesticides and should be produced without the use of such pesticides;
(11) Whereas, as and when ADI is derived from the scientific evaluation of pesticides carried out pursuant to Council Directive 91/414/EEC(11), as last amended by Commission Directive 1999/1/EC(12), this ADI will be used as the basis for the establishment of maximum residue limits for processed cereal-based foods and baby foods, using, where appropriate, the approach followed in the framework of Directives 86/362/EEC, 86/363/EEC and 90/642/EEC;
(12) Whereas this Directive reflects current knowledge about these substances; whereas any amendment, based on scientific or technical progress, will be decided by the procedure laid down in Article 13 of Directive 89/398/EEC;
(13) Whereas Directive 96/5/EC should be amended accordingly;
(14) Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,
Article 1
Directive 96/5/EC is hereby amended as follows:
1. The following indent is added to Article 1(4): "- 'pesticide residue' shall mean the residue in processed cereal-based foods and baby foods of a plant protection product, as defined in point 1 of Article 2 of Council Directive 91/414/EEC(13), including its metabolites and products resulting from its degradation or reaction,"
2. Article 6 is replaced by the following: "Article 6
1. Processed cereals-based foods and baby foods shall not contain any substance in such quantity as to endanger the health of infants and young children. Necessary maximum levels shall be established without delay.
2. Processed cereal-based foods and baby foods shall not contain residues of individual pesticides at levels exceeding 0,01 mg/kg, except for those substances for which specific levels have been set in Annex VII, in which case these specific levels shall apply.
The above levels apply to processed cereal-based foods and baby foods as proposed ready for consumption or as reconstitued according to the instructions of the manufacturer.
Analytical methods for determining the levels of pesticide residues shall be generally acceptable standardised methods.
3. Those pesticides listed in Annex VIII shall not be used in agricultural products intended for the production of processed cereal-based foods and baby foods.
4. Microbiological criteria shall be established as necessary;"
3. the following Annexes VII and VIII are added:
"ANNEX VII
Specific maximum residue levels of pesticides in processed cereal-based foods and baby foods
>PIC FILE= "L_1999124EN.000902.EPS">
ANNEX VIII
Pesticides which shall not be used in agricultural products intended for the production of processed cereal-based foods and baby foods.
Chemical name of the substance"
Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 June 2000. They shall forthwith inform the Commission thereof.
Those laws, regulations and administrative provisions shall be applied in such a way as to:
(a) permit trade in products conforming to this Directive no later than 30 June 2000;
(b) prohibit trade in products which do not comply with this Directive, with effect from 1 July 2002.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20001510"
] |
31999L0043
|
1999
|
Directive 1999/43/EC of the European Parliament and of the Council of 25 May 1999 amending for the 17th time Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),
(1) Whereas the necessary measures should be adopted for the smooth operation of the internal market;
(2) Whereas the European Parliament and the Council adopted on 29 March 1996 Decision No 646/96/EC of the European Parliament and of the Council of 29 March 1996 adopting an action plan to combat cancer within the framework for action in the field of public health (1996 to 2000)(4);
(3) Whereas, to improve health protection and consumer safety, substances classified as carcinogenic, mutagenic or toxic to reproduction and preparations containing them should not be placed on the market for use by the general public;
(4) Whereas Directive 94/60/EC of the European Parliament and of the Council of 20 December 1994 amending for the 14th time Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations(5) establishes, in the form of an Appendix concerning points 29, 30 and 31 of Annex I to Directive 76/769/EEC(6), a list containing substances classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2; whereas such substances and preparations should not be placed on the market for use by the general public;
(5) Whereas Directive 94/60/EC provides that the Commission will submit to the European Parliament and Council a proposal to extend this list not later than six months after publication of an adaptation to technical progress of Annex I to Directive 67/548/EEC(7), which contains substances classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2;
(6) Whereas Commission Directive 96/54/EC(8) adapting for the 22nd time Directive 67/548/EEC, and more particularly Annex I thereto, to technical progress, contains 16 substances newly classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2; whereas these substances should be added to points 29, 30 and 31 of the Appendix to Annex I to Directive 76/769/EEC, as consolidated by Directive 97/56/EC of the European Parliament and of the Council(9) amending Directive 76/769/EEC for the 16th time;
(7) Whereas the risks and advantages of the substances newly classified, by Directive 96/54/EC, as carcinogenic, mutagenic and toxic to reproduction of category 1 or 2 have been taken into account;
(8) Whereas Article 1(1)(f) of Directive 96/54/EC deletes eight entries from Annex I to Directive 67/548/EEC as the substances under these entries are already covered by other entries or their classification as carcinogens has been withdrawn; whereas five of these substances are included in the Appendix to point 29 of Annex I to Directive 76/769/EEC; whereas these entries should also be deleted in the latter Directive;
(9) Whereas this Directive applies without prejudice to Community legislation laying down minimum requirements for the protection of workers contained in Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(10), and individual directives based thereon, in particular Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work (sixth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(11),
Article 1
The substances listed in Annex I to this Directive shall be added to those substances listed in the Appendix concerning points 29, 30 and 31 of Annex I to Directive 76/769/EEC.
Article 2
The substances listed in Annex II to this Directive shall be deleted from those substances listed in the Appendix to point 29 of Annex I to Directive 76/769/EEC.
Article 3
1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive no later than one year after the date of its entry into force. They shall inform the Commission thereof forthwith.
They shall apply these measures 18 months after the date of the entry into force of this Directive.
2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
Article 4
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 5
This Directive is addressed to the Member States.
|
[
"UKSI20002897"
] |
31999L0044
|
1999
|
Directive 1999/44/EC of the European Parliament and of the Council of 25 May 1999 on certain aspects of the sale of consumer goods and associated guarantees
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty in the light of the joint text approved by the Conciliation Committee on 18 May 1999(3),
(1) Whereas Article 153(1) and (3) of the Treaty provides that the Community should contribute to the achievement of a high level of consumer protection by the measures it adopts pursuant to Article 95 thereof;
(2) Whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is guaranteed; whereas free movement of goods concerns not only transactions by persons acting in the course of a business but also transactions by private individuals; whereas it implies that consumers resident in one Member State should be free to purchase goods in the territory of another Member State on the basis of a uniform minimum set of fair rules governing the sale of consumer goods;
(3) Whereas the laws of the Member States concerning the sale of consumer goods are somewhat disparate, with the result that national consumer goods markets differ from one another and that competition between sellers may be distorted;
(4) Whereas consumers who are keen to benefit from the large market by purchasing goods in Member States other than their State of residence play a fundamental role in the completion of the internal market; whereas the artificial reconstruction of frontiers and the compartmentalisation of markets should be prevented; whereas the opportunities available to consumers have been greatly broadened by new communication technologies which allow ready access to distribution systems in other Member States or in third countries; whereas, in the absence of minimum harmonisation of the rules governing the sale of consumer goods, the development of the sale of goods through the medium of new distance communication technologies risks being impeded;
(5) Whereas the creation of a common set of minimum rules of consumer law, valid no matter where goods are purchased within the Community, will strengthen consumer confidence and enable consumers to make the most of the internal market;
(6) Whereas the main difficulties encountered by consumers and the main source of disputes with sellers concern the non-conformity of goods with the contract; whereas it is therefore appropriate to approximate national legislation governing the sale of consumer goods in this respect, without however impinging on provisions and principles of national law relating to contractual and non-contractual liability;
(7) Whereas the goods must, above all, conform with the contractual specifications; whereas the principle of conformity with the contract may be considered as common to the different national legal traditions; whereas in certain national legal traditions it may not be possible to rely solely on this principle to ensure a minimum level of protection for the consumer; whereas under such legal traditions, in particular, additional national provisions may be useful to ensure that the consumer is protected in cases where the parties have agreed no specific contractual terms or where the parties have concluded contractual terms or agreements which directly or indirectly waive or restrict the rights of the consumer and which, to the extent that these rights result from this Directive, are not binding on the consumer;
(8) Whereas, in order to facilitate the application of the principle of conformity with the contract, it is useful to introduce a rebuttable presumption of conformity with the contract covering the most common situations; whereas that presumption does not restrict the principle of freedom of contract; whereas, furthermore, in the absence of specific contractual terms, as well as where the minimum protection clause is applied, the elements mentioned in this presumption may be used to determine the lack of conformity of the goods with the contract; whereas the quality and performance which consumers can reasonably expect will depend inter alia on whether the goods are new or second-hand; whereas the elements mentioned in the presumption are cumulative; whereas, if the circumstances of the case render any particular element manifestly inappropriate, the remaining elements of the presumption nevertheless still apply;
(9) Whereas the seller should be directly liable to the consumer for the conformity of the goods with the contract; whereas this is the traditional solution enshrined in the legal orders of the Member States; whereas nevertheless the seller should be free, as provided for by national law, to pursue remedies against the producer, a previous seller in the same chain of contracts or any other intermediary, unless he has renounced that entitlement; whereas this Directive does not affect the principle of freedom of contract between the seller, the producer, a previous seller or any other intermediary; whereas the rules governing against whom and how the seller may pursue such remedies are to be determined by national law;
(10) Whereas, in the case of non-conformity of the goods with the contract, consumers should be entitled to have the goods restored to conformity with the contract free of charge, choosing either repair or replacement, or, failing this, to have the price reduced or the contract rescinded;
(11) Whereas the consumer in the first place may require the seller to repair the goods or to replace them unless those remedies are impossible or disproportionate; whereas whether a remedy is disproportionate should be determined objectively; whereas a remedy would be disproportionate if it imposed, in comparison with the other remedy, unreasonable costs; whereas, in order to determine whether the costs are unreasonable, the costs of one remedy should be significantly higher than the costs of the other remedy;
(12) Whereas in cases of a lack of conformity, the seller may always offer the consumer, by way of settlement, any available remedy; whereas it is for the consumer to decide whether to accept or reject this proposal;
(13) Whereas, in order to enable consumers to take advantage of the internal market and to buy consumer goods in another Member State, it should be recommended that, in the interests of consumers, the producers of consumer goods that are marketed in several Member States attach to the product a list with at least one contact address in every Member State where the product is marketed;
(14) Whereas the references to the time of delivery do not imply that Member States have to change their rules on the passing of the risk;
(15) Whereas Member States may provide that any reimbursement to the consumer may be reduced to take account of the use the consumer has had of the goods since they were delivered to him; whereas the detailed arrangements whereby rescission of the contract is effected may be laid down in national law;
(16) Whereas the specific nature of second-hand goods makes it generally impossible to replace them; whereas therefore the consumer's right of replacement is generally not available for these goods; whereas for such goods, Member States may enable the parties to agree a shortened period of liability;
(17) Whereas it is appropriate to limit in time the period during which the seller is liable for any lack of conformity which exists at the time of delivery of the goods; whereas Member States may also provide for a limitation on the period during which consumers can exercise their rights, provided such a period does not expire within two years from the time of delivery; whereas where, under national legislation, the time when a limitation period starts is not the time of delivery of the goods, the total duration of the limitation period provided for by national law may not be shorter than two years from the time of delivery;
(18) Whereas Member States may provide for suspension or interruption of the period during which any lack of conformity must become apparent and of the limitation period, where applicable and in accordance with their national law, in the event of repair, replacement or negotiations between seller and consumer with a view to an amicable settlement;
(19) Whereas Member States should be allowed to set a period within which the consumer must inform the seller of any lack of conformity; whereas Member States may ensure a higher level of protection for the consumer by not introducing such an obligation; whereas in any case consumers throughout the Community should have at least two months in which to inform the seller that a lack of conformity exists;
(20) Whereas Member States should guard against such a period placing at a disadvantage consumers shopping across borders; whereas all Member States should inform the Commission of their use of this provision; whereas the Commission should monitor the effect of the varied application of this provision on consumers and on the internal market; whereas information on the use made of this provision by a Member State should be available to the other Member States and to consumers and consumer organisations throughout the Community; whereas a summary of the situation in all Member States should therefore be published in the Official Journal of the European Communities;
(21) Whereas, for certain categories of goods, it is current practice for sellers and producers to offer guarantees on goods against any defect which becomes apparent within a certain period; whereas this practice can stimulate competition; whereas, while such guarantees are legitimate marketing tools, they should not mislead the consumer; whereas, to ensure that consumers are not misled, guarantees should contain certain information, including a statement that the guarantee does not affect the consumer's legal rights;
(22) Whereas the parties may not, by common consent, restrict or waive the rights granted to consumers, since otherwise the legal protection afforded would be thwarted; whereas this principle should apply also to clauses which imply that the consumer was aware of any lack of conformity of the consumer goods existing at the time the contract was concluded; whereas the protection granted to consumers under this Directive should not be reduced on the grounds that the law of a non-member State has been chosen as being applicable to the contract;
(23) Whereas legislation and case-law in this area in the various Member States show that there is growing concern to ensure a high level of consumer protection; whereas, in the light of this trend and the experience acquired in implementing this Directive, it may be necessary to envisage more far-reaching harmonisation, notably by providing for the producer's direct liability for defects for which he is responsible;
(24) Whereas Member States should be allowed to adopt or maintain in force more stringent provisions in the field covered by this Directive to ensure an even higher level of consumer protection;
(25) Whereas, according to the Commission recommendation of 30 March 1998 on the principles applicable to the bodies responsible for out-of-court settlement of consumer disputes(4), Member States can create bodies that ensure impartial and efficient handling of complaints in a national and cross-border context and which consumers can use as mediators;
(26) Whereas it is appropriate, in order to protect the collective interests of consumers, to add this Directive to the list of Directives contained in the Annex to Directive 98/27/EC of the European Parliament and of the Council of 19 May 1998 on injunctions for the protection of consumers' interests(5),
Article 1
Scope and definitions
1. The purpose of this Directive is the approximation of the laws, regulations and administrative provisions of the Member States on certain aspects of the sale of consumer goods and associated guarantees in order to ensure a uniform minimum level of consumer protection in the context of the internal market.
2. For the purposes of this Directive:
(a) consumer: shall mean any natural person who, in the contracts covered by this Directive, is acting for purposes which are not related to his trade, business or profession;
(b) consumer goods: shall mean any tangible movable item, with the exception of:
- goods sold by way of execution or otherwise by authority of law,
- water and gas where they are not put up for sale in a limited volume or set quantity,
- electricity;
(c) seller: shall mean any natural or legal person who, under a contract, sells consumer goods in the course of his trade, business or profession;
(d) producer: shall mean the manufacturer of consumer goods, the importer of consumer goods into the territory of the Community or any person purporting to be a producer by placing his name, trade mark or other distinctive sign on the consumer goods;
(e) guarantee: shall mean any undertaking by a seller or producer to the consumer, given without extra charge, to reimburse the price paid or to replace, repair or handle consumer goods in any way if they do not meet the specifications set out in the guarantee statement or in the relevant advertising;
(f) repair: shall mean, in the event of lack of conformity, bringing consumer goods into conformity with the contract of sale.
3. Member States may provide that the expression "consumer goods" does not cover second-hand goods sold at public auction where consumers have the opportunity of attending the sale in person.
4. Contracts for the supply of consumer goods to be manufactured or produced shall also be deemed contracts of sale for the purpose of this Directive.
Article 2
Conformity with the contract
1. The seller must deliver goods to the consumer which are in conformity with the contract of sale.
2. Consumer goods are presumed to be in conformity with the contract if they:
(a) comply with the description given by the seller and possess the qualities of the goods which the seller has held out to the consumer as a sample or model;
(b) are fit for any particular purpose for which the consumer requires them and which he made known to the seller at the time of conclusion of the contract and which the seller has accepted;
(c) are fit for the purposes for which goods of the same type are normally used;
(d) show the quality and performance which are normal in goods of the same type and which the consumer can reasonably expect, given the nature of the goods and taking into account any public statements on the specific characteristics of the goods made about them by the seller, the producer or his representative, particularly in advertising or on labelling.
3. There shall be deemed not to be a lack of conformity for the purposes of this Article if, at the time the contract was concluded, the consumer was aware, or could not reasonably be unaware of, the lack of conformity, or if the lack of conformity has its origin in materials supplied by the consumer.
4. The seller shall not be bound by public statements, as referred to in paragraph 2(d) if he:
- shows that he was not, and could not reasonably have been, aware of the statement in question,
- shows that by the time of conclusion of the contract the statement had been corrected, or
- shows that the decision to buy the consumer goods could not have been influenced by the statement.
5. Any lack of conformity resulting from incorrect installation of the consumer goods shall be deemed to be equivalent to lack of conformity of the goods if installation forms part of the contract of sale of the goods and the goods were installed by the seller or under his responsibility. This shall apply equally if the product, intended to be installed by the consumer, is installed by the consumer and the incorrect installation is due to a shortcoming in the installation instructions.
Article 3
Rights of the consumer
1. The seller shall be liable to the consumer for any lack of conformity which exists at the time the goods were delivered.
2. In the case of a lack of conformity, the consumer shall be entitled to have the goods brought into conformity free of charge by repair or replacement, in accordance with paragraph 3, or to have an appropriate reduction made in the price or the contract rescinded with regard to those goods, in accordance with paragraphs 5 and 6.
3. In the first place, the consumer may require the seller to repair the goods or he may require the seller to replace them, in either case free of charge, unless this is impossible or disproportionate.
A remedy shall be deemed to be disproportionate if it imposes costs on the seller which, in comparison with the alternative remedy, are unreasonable, taking into account:
- the value the goods would have if there were no lack of conformity,
- the significance of the lack of conformity, and
- whether the alternative remedy could be completed without significant inconvenience to the consumer.
Any repair or replacement shall be completed within a reasonable time and without any significant inconvenience to the consumer, taking account of the nature of the goods and the purpose for which the consumer required the goods.
4. The terms "free of charge" in paragraphs 2 and 3 refer to the necessary costs incurred to bring the goods into conformity, particularly the cost of postage, labour and materials.
5. The consumer may require an appropriate reduction of the price or have the contract rescinded:
- if the consumer is entitled to neither repair nor replacement, or
- if the seller has not completed the remedy within a reasonable time, or
- if the seller has not completed the remedy without significant inconvenience to the consumer.
6. The consumer is not entitled to have the contract rescinded if the lack of conformity is minor.
Article 4
Right of redress
Where the final seller is liable to the consumer because of a lack of conformity resulting from an act or omission by the producer, a previous seller in the same chain of contracts or any other intermediary, the final seller shall be entitled to pursue remedies against the person or persons liable in the contractual chain. the person or persons liable against whom the final seller may pursue remedies, together with the relevant actions and conditions of exercise, shall be determined by national law.
Article 5
Time limits
1. The seller shall be held liable under Article 3 where the lack of conformity becomes apparent within two years as from delivery of the goods. If, under national legislation, the rights laid down in Article 3(2) are subject to a limitation period, that period shall not expire within a period of two years from the time of delivery.
2. Member States may provide that, in order to benefit from his rights, the consumer must inform the seller of the lack of conformity within a period of two months from the date on which he detected such lack of conformity.
Member States shall inform the Commission of their use of this paragraph. The Commission shall monitor the effect of the existence of this option for the Member States on consumers and on the internal market.
Not later than 7 January 2003, the Commission shall prepare a report on the use made by Member States of this paragraph. This report shall be published in the Official Journal of the European Communities.
3. Unless proved otherwise, any lack of conformity which becomes apparent within six months of delivery of the goods shall be presumed to have existed at the time of delivery unless this presumption is incompatible with the nature of the goods or the nature of the lack of conformity.
Article 6
Guarantees
1. A guarantee shall be legally binding on the offerer under the conditions laid down in the guarantee statement and the associated advertising.
2. The guarantee shall:
- state that the consumer has legal rights under applicable national legislation governing the sale of consumer goods and make clear that those rights are not affected by the guarantee,
- set out in plain intelligible language the contents of the guarantee and the essential particulars necessary for making claims under the guarantee, notably the duration and territorial scope of the guarantee as well as the name and address of the guarantor.
3. On request by the consumer, the guarantee shall be made available in writing or feature in another durable medium available and accessible to him.
4. Within its own territory, the Member State in which the consumer goods are marketed may, in accordance with the rules of the Treaty, provide that the guarantee be drafted in one or more languages which it shall determine from among the official languages of the Community.
5. Should a guarantee infringe the requirements of paragraphs 2, 3 or 4, the validity of this guarantee shall in no way be affected, and the consumer can still rely on the guarantee and require that it be honoured.
Article 7
Binding nature
1. Any contractual terms or agreements concluded with the seller before the lack of conformity is brought to the seller's attention which directly or indirectly waive or restrict the rights resulting from this Directive shall, as provided for by national law, not be binding on the consumer.
Member States may provide that, in the case of second-hand goods, the seller and consumer may agree contractual terms or agreements which have a shorter time period for the liability of the seller than that set down in Article 5(1). Such period may not be less than one year.
2. Member States shall take the necessary measures to ensure that consumers are not deprived of the protection afforded by this Directive as a result of opting for the law of a non-member State as the law applicable to the contract where the contract has a close connection with the territory of the Member States.
Article 8
National law and minimum protection
1. The rights resulting from this Directive shall be exercised without prejudice to other rights which the consumer may invoke under the national rules governing contractual or non-contractual liability.
2. Member States may adopt or maintain in force more stringent provisions, compatible with the Treaty in the field covered by this Directive, to ensure a higher level of consumer protection.
Article 9
Member States shall take appropriate measures to inform the consumer of the national law transposing this Directive and shall encourage, where appropriate, professional organisations to inform consumers of their rights.
Article 10
The Annex to Directive 98/27/EC shall be completed as follows: "10. Directive 1999/44/EC of the European Parliament and of the Council of 25 May 1999 on certain aspects of the sale of consumer goods and associated guarantees (OJ L 171, 7.7.1999, p. 12).".
Article 11
Transposition
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 2002. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive, or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.
Article 12
Review
The Commission shall, not later than 7 July 2006, review the application of this Directive and submit to the European Parliament and the Council a report. The report shall examine, inter alia, the case for introducing the producer's direct liability and, if appropriate, shall be accompanied by proposals.
Article 13
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 14
This Directive is addressed to the Member States.
|
[
"UKSI20023045",
"UKPGA20150015"
] |
31999L0050
|
1999
|
Commission Directive 1999/50/EC of 25 May 1999 amending Directive 91/321/EEC on infant formulae and follow-on formulae (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs for particular nutritional uses(1), as amended by Directive 96/84/EC of the European Parliament and of the Council(2), and in particular Article 4(1) thereof,
After consulting the Scientific Committee for Food,
(1) Whereas Article 6 of Commission Directive 91/321/EEC(3), as last amended by Directive 96/4/EC(4), provides that infant formulae and follow-on formulae shall not contain any substance in such quantity as to endanger the health of infants and young children and that necessary maximum levels for such substances shall be established without delay;
(2) Whereas different regulations on the maximum levels of pesticide residues in such products cause trade barriers between certain Member States;
(3) Whereas maximum levels for pesticide residues stipulated in Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables(5), as last amended by Directive 97/41/EC(6), 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(7), as last amended by Commission Directive 98/82/EC(8), 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin(9), as last amended by Directive 98/82/EC, and 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables(10), as last amended by Directive 98/82/EC, are without prejudice to specific provisions applicable to infant formulae and follow-on formulae;
(4) Whereas, taking into account the Community's international obligations, in cases where the relevant scientific evidence is insufficient, the precautionary principle allows the Community to provisionally adopt measures on the basis of available pertinent information, pending an additional assessment of risk and a review of the measure within a reasonable period of time;
(5) Whereas on the basis of the two opinions given by the Scientific Committee for Food on 19 September 1997 and 4 June 1998 there are at present doubts as to the adequacy of existing acceptable daily intake values (ADI) for the protection of the health of infants and young children; whereas the doubts expressed concern not only pesticides and pesticide residues, but also dangerous chemical substances, and consequently the Commission will examine the possibility of fixing, as soon as possible, maximum levels for heavy metals in foods intended for infants and young children;
(6) Whereas, therefore, as far as foods for particular nutritional uses intended for infants and young children are concerned, it is appropriate to adopt a very low common limit for all pesticides;
(7) Whereas this very low common limit should be fixed at 0,01 mg/kg which is in practice the minimum detectable level;
(8) Whereas severe limitations on pesticide residues should be required; whereas, with careful selection of raw materials, and given that infant formulae and follow-on formulae undergo extensive processing during their manufacture, it is feasible to produce products containing very low levels of pesticide residues;
(9) Whereas, however, for a small number of pesticides even such low levels might allow the possibility that under worst-case intake conditions the ADI of these pesticides is exceeded; whereas, therefore, infant formulae and follow-on formulae should be free of those particular pesticides and should be produced without the use of such pesticides;
(10) Whereas this Directive reflects current knowledge about these substances; whereas any amendment, based on scientific or technical progress, will be decided by the procedure laid down in Article 13 of Directive 89/398/EEC;
(11) Whereas Directive 91/321/EEC should be amended accordingly;
(12) Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,
Article 1
Directive 91/321/EEC is hereby amended as follows:
1. the following point (e) is added to Article l(2):
"(e) 'pesticide residue' means the residue in infant formulae and follow-on formulae of a plant protection product, as defined in point 1 of Article 2 of Council Directive 91/414/EEC(11), including its metabolites and products resulting from its degradation or reaction;
2. Article 6 is replaced by the following:
"Article 6
1. Infant formulae and follow-on formulae shall not contain any substance in such quantity as to endanger the health of infants and young children. Necessary maximum levels shall be established without delay.
2. Infant formulae and follow-on formulae shall not contain residues of individual pesticides at levels exceeding 0,01 mg/kg of the product as proposed ready for consumption or as reconstituted according to the instructions of the manufacturer.
Analytical methods for determining the levels of pesticide residues shall be generally acceptable standardised methods.
3. Those pesticides listed in Annex IX shall not be used in agricultural products intended for the production of infant formulae and follow-on formulae.
4. Microbiological criteria shall be established as necessary.";
3. the following is added as Annex IX:
"ANNEX IX
Pesticides which shall not be used in agricultural products intended for the production of infant formulae and follow-on formulae
Chemical name of the substance
..."
Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 June 2000. They shall forthwith inform the Commission thereof.
Those laws, regulations and administrative provisions shall be applied in such a way as to:
(a) permit trade in products conforming to this Directive no later than 30 June 2000,
(b) prohibit trade in products which do not comply with this Directive, with effect from 1 July 2002.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20001509"
] |
31999L0054
|
1999
|
Commission Directive 1999/54/EC of 26 May 1999 amending Council Directive 66/402/EEC on the marketing of cereal seed
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed(1), as last amended by Directive 1999/8/EC(2), and in particular Articles 2(1b) and 21b thereof,
(1) Whereas the abovementioned Directive makes provisions for including hybrids of self-pollinating triticale within its scope and empowers the Commission to adopt the necessary amendments to the definitions in Article 2(1) of that Directive; whereas, owing to the increased importance in the Community of the hybrids of self-pollinating triticale, they should be included within the scope of the Directive and consequently amendments to the definitions of "basic seed" and "certified seed" should be adopted;
(2) Whereas the abovementioned Directive does not establish the conditions to be satisfied by the crop and the seed of hybrids of Avena sativa, Hordeum vulgare, Oryza sativa, Triticum aestivum, Triticum durum, Triticum spelta and self-pollinating Triticosecale; whereas such conditions may be established and Annexes I and II to Directive 66/402/EEC amended accordingly; whereas, owing to the increased importance in the Community of the abovementioned hybrids, the conditions to be satisfied by the crop and by the seed, in particular where seed is produced by use of a chemical hybridisation agent, should be established;
(3) Whereas the measures provided in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,
Article 1
Directive 66/402/EEC is hereby amended as follows:
1. in Article 2(1)Ca, the introductory sentence is replaced by the following: "Basic seed (hybrids of oats, barley, rice, rye, wheat, durum wheat, spelt wheat and self-pollinating triticale)";
2. in Article 2(1)E the introductory sentence is replaced by the following: "Certified seed (canary grass, other than hybrids, rye, sorghum, sudan grass, maize and hybrids of oats, barley, rice, wheat, durum wheat, spelt wheat and self pollinating triticale): seed";
3. in point 3 of Annex I the first and the second sentences are replaced by the following: "The crop shall have sufficient varietal identity and varietal purity or, in the case of a crop of an inbred line, sufficient identity and purity as regards its characteristics. For the production of seed of hybrid varieties, the abovementioned provisions shall also apply to the characteristics of the components, including male sterility or fertility restoration";
4. the following point 3b is inserted in Annex I: "3b. Crops to produce certified seed of hybrids of oats, barley, rice, wheat, durum wheat, spelt wheat and sel-pollinating triticale
(a) The crop shall conform to the following standards as regards distances from neighbouring sources of pollen which may result in undesirable foreign pollination:
- the minimum distance of the female component shall be 25 m from any other variety of the same species except from a crop of the male component,
- this distance can be disregarded if there is sufficient protection from any undesirable foreign pollination.
(b) The crop shall have sufficient identity and purity as regards the characteristics of the components.
Where seed is produced by use of a chemical hybridisation agent, the crop shall conform to the following standards or other conditions:
(i) the minimum varietal purity of each component shall be:
- oats, barley, rice, wheat, durum wheat and spelt wheat: 99,7 %,
- self-pollinating triticale: 99,0 %;
(ii) the minimum hybridity must be 95 %. The percentage hybridity shall be assessed in accordance with current international methods, in so far as such methods exist. In cases where the hybridity is determined during seed testing prior to certification, the determination of the hybridity during field inspection need not be done.";
5. in point 1 of Annex II, the first and the second sentences are replaced by the following: "The seed shall have sufficient varietal identity and varietal purity or, in the case of seed of an inbred line, sufficient identity and purity as regards its characteristics. For the seed of hybrid varieties, the abovementioned provisions shall also apply to the characteristics of the components.";
6. in the heading of Section 1.Aa of Annex II, "other than hybrids" is inserted after "Triticosecale";
7. the following section is added to Section 1.Aa of Annex II: "Ab. Hybrids of oats, barley, rice, wheat, durum wheat, spelt wheat and self-pollinating triticale.
The minimum varietal purity of the seed of the category certified seed shall be 90 %. It shall be examined in official post control tests on an approriate proportion of samples."
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive not later than 1 July 2000. They shall forthwith inform the Commission thereof.
2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The procedure for such reference shall be adopted by Member States.
3. Member States shall communicate to the Commission the text of the main provisions of domestic law they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
|
[
"UKSI19992196"
] |
31999L0052
|
1999
|
Commission Directive 1999/52/EC of 26 May 1999 adapting to technical progress Council Directive 96/96/EC on the approximation of the laws of the Member States relating to roadworthiness tests for motor vehicles and their trailers (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 96/96/EC of 20 December 1996 and Article 7(2) thereof on the approximation of the laws of the Member States relating to roadworthiness tests for motor vehicles and their trailers(1),
(1) Whereas the first auto-oil programme(2) identified the standard of motor vehicles' maintenance as a key constituent in traffic's effect on air quality;
(2) Whereas Section 8.2 of Annex II Directive 96/96/EC to specifies the tests to be carried out at periodic inspections to check that vehicles are properly maintained;
(3) Whereas Section 8.2.2 of Annex II Council Directive 92/55/EEC(3) to specifies that, from 1 January 1996, diesel vehicles need to be tested for the opacity of the generated exhaust smoke during a transient, "free acceleration" engine test where the engine is accelerated against its own inertia;
(4) Whereas, this Directive establishes a technical adaptation that will improve the performance of roadworthiness testing of diesel engined vehicle emissions;
(5) Whereas, further work needs to be done in the field of developing alternative test procedures to check the maintenance conditions of diesel engined vehicles, particularly concerning particulates and NOx;
(6) Whereas, the provisions of this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of the Directive on Motor Vehicle Roadworthiness testing established under Article 8 of Directive 96/96/EC,
Article 1
Directive 96/96/EC is modified as follows:
Annex II, point 8.2.2 is replaced by the following: "8.2.2. Motor vehicles equipped with compression ignition (diesel) engines:
(a) Exhaust gas opacity to be measured during free acceleration (no load from idle up to cut-off speed) with gear lever in neutral and clutch engaged.
(b) Vehicle preconditioning:
1. Vehicles may be tested without preconditioning although for safety reasons checks should be made that the engine is warm and in a satisfactory mechanical condition.
2. Except as specified in subparagraph (d)(5), no vehicle will be failed unless it has been preconditioned according to the following requirements.
3. Engine shall be fully warm, for instance the engine oil temperature measured by a probe in the oil level dipstick tube to be at least 80° C, or normal operating temperature if lower, or the engine block temperature measured by the level of infrared radiation to be at least an equivalent temperature. If, owing to vehicle configuration, this measurement is impractical, the establishment of the engine's normal operating temperature may be made by other means, for example by the operation of the engine cooling fan.
4. Exhaust system shall be purged by at least three free acceleration cycles or by an equivalent method.
(c) Test procedure:
1. Visual inspection of the relevant parts of the motor vehicle's emission system to check that there are no leaks.
2. Engine, and any turbocharger fitted, to be at idle before the start of each free acceleration cycle. For heavy-duty diesels, this means waiting for at least 10 seconds after the release of the throttle.
3. To initiate each free acceleration cycle, the throttle pedal must be fully depressed quickly and continuously (in less than one second) but not violently, so as to obtain maximum delivery from the injection pump.
4. During each free acceleration cycle, the engine shall reach cut-off speed or, for vehicles with automatic transmissions, the speed specified by the manufacturer or if this data is not available then two thirds of the cut off speed, before the throttle is released. This could be checked, for instance, by monitoring engine speed or by allowing a sufficient time to elapse between initial throttle depression and release, which in the case of vehicles in categories 1 and 2 of Annex I, should be at least two seconds.
(d) Limit values:
1. The level of concentration must not exceed the level recorded on the plate pursuant to Council Directive 72/306/EEC (2).
2. Where this information is not available or where Member States' competent authorities decide not to use it as a reference, the limit values of the coefficient of absorption are as follows: maximum coefficient of absorption for:
- naturally aspirated diesel engines = 2,5 m-1,
- turbo-charged diesel engines = 3,0 m-1
or equivalent values where use is made of equipment of a type different from that used for EC type-approval.
3. Vehicles registered or put into service for the first time before 1 January 1980 are exempted from these requirements.
4. Vehicles shall only be failed if the arithmetic means of at least the last three free acceleration cycles are in excess of the limit value. This may be calculated by ignoring any measurements that depart significantly from the measured mean, or the result of any other statistical calculation that takes account of the scattering of the measurements. Member States may limit the maximum number of test cycles.
5. To avoid unneccessary testing, Member States may, by way of exception from the provisions of paragraph 8.2.2(d)(4), fail vehicles which have measured values significantly in excess of the limit values after less than three free acceleration cycles or after the purging cycles (or equivalent) specified in subparagraph (b)(3). Equally to avoid unneccessary testing, Member States may, by way of exception from the provisions of paragraph 8.2.2(d)(4), pass vehicles which have measured values significantly below the limit values after less than three free acceleration cycles or after the purging cycles (or equivalent) specified in subpragraph (b)(3)."
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 October 2000. They shall forthwith inform the Commission thereof.
When the Member States adopt these measures they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.
Article 3
This Directive shall enter into force on the day following its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20001434"
] |
31999L0053
|
1999
|
Commission Directive 1999/53/EC of 26 May 1999 amending Annex III to Council Directive 77/93/EEC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(1), as last amended by Commission Directive 98/2/EC(2), and in particular Article 13, second paragraph, third indent, thereof,
(1) Whereas by Commission Directive 92/76/EEC(3), as last amended by Directive 98/100/EC(4), Greece and France (Corsica) were provisionally recognised as protected zones against unknown non-European harmful organisms on fruits of Citrus L., Fortunella Swingle, Poncirus Raf., and their hybrids; whereas Italy was also provisionally recognised as a protected zone against unknown non-European harmful organisms on fruits of Citrus L., Fortunella Swingle, Poncirus Raf., and their hybrids, except Citrus paradisi Macf.; whereas Commission Directive 95/40/EC(5) extended this provisional recognition only until 1 April 1996; whereas the provisions in Directive 77/93/EEC relating to the said protected zones are therefore obsolete and should be repealed for the sake of legal clarity;
(2) Whereas this amendment is in accordance with the requests of the Member States concerned;
(3) Whereas, therefore, the relevant Annex III to Directive 77/93/EEC should be amended accordingly;
(4) Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,
Article 1
Annex III Part B to Directive 77/93/EEC, points 2 and 3 are deleted.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 15 July 1999. They shall forthwith inform the Commission thereof.
When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
2. Member States shall immediately communicate to the Commission the main provisions of domestic law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof.
Article 3
This Directive shall enter into force on the day following its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI19961165"
] |
31999L0045
|
1999
|
Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal of the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),
(1) Whereas Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(4) has been amended on several occasions; whereas on the occasion of further amendments, the said Directive should, for reasons of clarity, be recast;
(2) Whereas, in spite of Community provisions, the rules applying to certain dangerous preparations in the Member States exhibit considerable differences as regards classification, packaging and labelling; whereas these differences constitute a barrier to trade, create unequal competition conditions and directly affect the functioning of the internal market; whereas it is therefore necessary to remove this barrier to trade by approximating the relevant legislation existing in the Member States;
(3) Whereas measures for the approximation of the provisions of the Member States affecting the establishment and functioning of the internal market must, in so far as they concern health, safety and protection of man and the environment, adopt a high level of protection as a basis; whereas this Directive must, at the same time, ensure protection for the general public, and, in particular, persons who come into contact with dangerous preparations in the course of their work or in the pursuit of a hobby, protection for consumers and for the environment;
(4) Whereas containers containing certain categories of dangerous preparations offered or sold to the general public must be fitted with child-resistant fastenings and/or carry a tactile warning of danger; whereas certain preparations not falling within these categories of danger may nevertheless, owing to their composition, present a danger for children; whereas the packaging of such preparations should therefore be equipped with child-resistant fastenings;
(5) Whereas it is necessary to provide concentration limits expressed as a volume/volume percentage in the case of preparations marketed in gaseous form;
(6) Whereas this Directive contains special labelling provisions applicable to certain preparations; whereas, to ensure an adequate level of protection for man and the environment, special labelling provisions must also be introduced for certain preparations which, although not dangerous within the meaning of this Directive, may nevertheless present a danger to the user;
(7) Whereas on 30 April 1992 the Council adopted Directive 92/32/EEC amending for the seventh time Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(5); whereas on 27 April 1993 the Commission adopted Directive 93/21/EEC(6) adapting to technical progress for the 18th time Council Directive 67/548/EEC; whereas new criteria developed for classifying and labelling substances dangerous for the environment were introduced by those Directives, together with the appropriate symbols, indications of danger, risk phrases and safety advice required to appear on labelling; whereas provisions should be adopted at Community level on the classification and labelling of preparations to take account of their effects on the environment and whereas it is therefore necessary to introduce a method for assessing the hazards of a given preparation for the environment either by a calculation method, or by determining the ecotoxicological properties by test methods under certain conditions;
(8) Whereas the number of animals used for experiments should be reduced to a minimum, in accordance with the provisions of Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(7); whereas Article 7(2) of that Directive stipulates that an experiment shall not be performed if another scientifically satisfactory method of obtaining the results sought, not entailing the use of an animal, is reasonably and practically available; whereas, therefore, this Directive makes use of the results of assessments of toxicological and ecotoxicological properties only when these are already known and entails no obligation to conduct further experiments on animals;
(9) Whereas it is necessary to define what human experience might be considered for the evaluation of the health hazards of a preparation; whereas, if clinical studies may be accepted, it is taken as given that such studies comply with the Helsinki Declaration and OECD Guidelines for Good Clinical Practice;
(10) Whereas the characteristics of alloys are such that it may not be possible accurately to determine their properties using currently available conventional methods; whereas it is therefore necessary to develop a specific method of classification which takes into account their particular chemical properties; whereas the Commission, in consultation with Member States, will examine this need and submit a proposal, if appropriate, before the implementation date of this Directive;
(11) Whereas classification, packaging and labelling of plant protection products covered by Council Directive 78/631/EEC of 26 June 1978 on the approximation of the laws of the Member States relating to the classification, packaging and labelling of dangerous preparations (pesticides)(8) need to be revised taking into account technical and scientific developments as well as regulatory developments following implementation of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(9);
(12) Whereas Directive 91/414/EEC and Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market(10), in contrast to the provisions applicable to chemical preparations covered by this Directive, provide for an authorisation procedure for each product on the basis of a dossier presented by the applicant and an assessment carried out by the competent authority in each Member State; whereas furthermore that authorisation procedure includes a control relating specifically to the classification, packaging and labelling of each product before it is placed on the market; whereas it is appropriate, as part of a clear and transparent information process, to classify and label plant protection products according to the provisions of this Directive, and also to provide instructions for use in accordance with the results of the evaluation carried out in the framework of Directive 91/414/EEC and to ensure that the labelling satisfies the high level of protection sought by both this Directive and Directive 91/414/EEC; whereas, in addition, a safety data sheet has to be established for plant protectioon products in accordance with this Directive;
(13) Whereas it is appropriate to provide, in relation to environmental labelling, that specific exemptions or specific provisions may be decided upon in specific cases where it can be demonstrated that the overall environmental impact of the product types in question is lower than that of corresponding product types;
(14) Whereas, although munitions are not covered by this Directive, explosives marketed to produce an explosive or pyrotechnic effect may, through their chemical composition, present dangers to health; whereas it is therefore necessary as part of a transparent information process to classify them and assign to them a safety data sheet in accordance with the provisions of this Directive and also to label them in accordance with the international rules used for the transport of dangerous goods;
(15) Whereas, in order to take account of certain preparations which, although they are not considered dangerous under this Directive, may nevertheless present a danger for users, it is necessary to extend certain provisions of this Directive to cover such preparations;
(16) Whereas the label constitutes a basic tool for users of the dangerous preparations in so far as it provides them with the initial essential concise information; whereas it nevertheless needs to be supplemented by a two-fold system of more detailed information, consisting firstly of the safety data sheet, intended for professional users as defined by Commission Directive 91/155/EEC of 5 March 1991 defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Directive 88/379/EEC(11) and secondly of the bodies appointed by the Member States which are responsible for the provision of information solely for medical purposes, both preventive and curative;
(17) Whereas, on the basis of information to be supplied by the Member States and the various parties concerned, the Commission will submit a report to the European Parliament and the Council within two years of the entry into force of this Directive on experience with the present overall approach to labelling of dangerous preparations and in particular on its understanding and application by users, experience with publicity campaigns and educational and training programmes; whereas, on the basis of this report, the Commission will, if appropriate, submit the necessary proposals;
(18) Whereas it is necessary to require safety data sheets providing proportionate information on the dangers to man and the environment arising from preparations not classified as dangerous within the meaning of this Directive but containing substances classified as dangerous or having a Community exposure limit; whereas the Commission, on the basis of information submitted by Member States, will review Directive 91/155/EEC and submit proposals, if appropriate, before the expiry of the date for implementation of this Directive;
(19) Whereas, in the case of preparations classified as dangerous within the meaning of this Directive, it is appropriate to permit Member States to allow certain derogations with respect to labelling where the packaging is too small, or otherwise unsuitable for labelling, or where such small packaging or such small quantities are involved that there is no reason to fear any danger to man or the environment; whereas in such cases appropriate consideration should also be given to the approximation of the relevant provisions at Community level; whereas the Commission will therefore examine the needs for harmonisation and, if appropriate, submit proposals;
(20) Whereas the confidentiality of certain substances contained in the preparations should be guaranteed and whereas it is therefore necessary to institute a system which allows the person responsible for placing the preparation on the market to request confidentiality for such substances;
(21) Whereas the provisions of this Directive will have regard to the commitment entered into by the Community and its Member States, in accordance with the goals for sustainable development set under Agenda 21, Chapter 19, at the UNCED conference held in June 1992 in Rio de Janeiro, to strive for the future harmonisation of systems for the classification of dangerous substances and preparations;
(22) Whereas the Commission should be given the powers necessary to adapt all the Annexes to this Directive to technical progress;
(23) Whereas the adoption of this Directive should not affect the obligations of the Member States concerning the deadlines for transposition into national law and for application of the Directives indicated in Annex VIII;
(24) Whereas the Directives indicated in Annex VIII should be repealed, subject to certain conditions; whereas the conditions for repealing the Directives indicated in Annex VIII should be specified for Austria, Finland and Sweden in order to take account of the present level of their legislation, in particular as regards the protection of health and the protection of the environment,
Article 1
Objectives and scope
1. This Directive aims at the approximation of the laws, regulations and administrative provisions of the Member States relating to:
- the classification, packaging and labelling of dangerous preparations, and to
- the approximation of specific provisions for certain preparations which may present hazards, whether or not they are classified as dangerous within the meaning of this Directive,
when such preparations are placed on the market of the Member States.
2. This Directive shall apply to preparations which:
- contain at least one dangerous substance within the meaning of Article 2,
and
- are considered dangerous within the meaning of Article 5, 6 or 7.
3. The specific provisions set out:
- in Article 9 and defined in Annex IV,
- in Article 10 and defined in Annex V, and
- in Article 14
shall also apply to preparations which are not considered dangerous within the meaning of Articles 5, 6 or 7 but may nevertheless present a specific hazard.
4. Without prejudice to Directive 91/414/EEC, the articles on classification, packaging, labelling and safety data sheets of this Directive shall apply to plant protection products.
5. This Directive shall not apply to the following preparations in the finished state, intended for the final user:
(a) medicinal products for human or veterinary use, as defined in Directive 65/65/EEC(12);
(b) cosmetic products as defined in Directive 76/768/EEC(13);
(c) mixtures of substances which, in the form of waste, are covered by Directives 75/442/EEC(14) and 78/319/EEC(15);
(d) foodstuffs;
(e) animal feedingstuffs;
(f) preparations containing radioactive substances as defined by Directive 80/836/Euratom(16);
(g) medical devices which are invasive or used in direct physical contact with the human body in so far as Community measures lay down provisions for the classification and labelling of dangerous substances and preparations which ensure the same level of information provision and protection as this Directive.
6. This Directive shall not apply to:
- the carriage of dangerous preparations by rail, road, inland waterway, sea or air,
- preparations in transit which are under customs supervision, provided they do not undergo any treatment or processing.
Article 2
Definitions
1. For the purposes of this Directive:
(a) "substances" means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;
(b) "preparations" means mixtures or solutions composed of two or more substances;
(c) "polymer" means a substance consisting of molecules characterised by the sequence of one or more types of monomer units and comprising a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant and consists of less than a simple weight majority of molecules of the same molecular weight. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. In the context of this definition a "monomer unit" means the reacted form of a monomer in a polymer;
(d) (...);
(e) "placing on the market" means making available to third parties. Importation into the Community customs territory shall be deemed to be placing on the market for the purposes of this Directive;
(f) "scientific research and development" means scientific experimentation, analysis or chemical research carried out under controlled conditions; it includes the determination of intrinsic properties, performance and efficacy as well as scientific investigation related to product development;
(g) "process-orientated research and development" means the further development of a substance in the course of which pilot plant or production trials are used to test the fields of application of the substance;
(h) "Einecs" means the European Inventory of Existing Commercial Chemical Substances. This inventory contains the definitive list of all chemical substances deemed to be on the Community market on 18 September 1981.
2. The following are "dangerous" within the meaning of this Directive:
(a) explosive substances and preparations: solid, liquid, pasty or gelatinous substances and preparations which may also react exothermically without atmospheric oxygen thereby quickly evolving gases, and which, under defined test conditions, detonate, quickly deflagrate or upon heating explode when partially confined;
(b) oxidising substances and preparations: substances and preparations which give rise to a highly exothermic reaction in contact with other substances, particularly flammable substances;
(c) extremely flammable substances and preparations: liquid substances and preparations having an extremely low flash-point and a low boiling-point and gaseous substances and preparations which are flammable in contact with air at ambient temperature and pressure;
(d) highly flammable substances and preparations:
- substances and preparations which may become hot and finally catch fire in contact with air at ambient temperature without any application of energy, or
- solid substances and preparations which may readily catch fire after brief contact with a source of ignition and which continue to burn or to be consumed after removal of the source of ignition, or
- liquid substances and preparations having a very low flash-point, or
- substances and preparations which, in contact with water or damp air, evolve extremely flammable gases in dangerous quantities;
(e) flammable substances and preparations: liquid substances and preparations having a low flash-point;
(f) very toxic substances and preparations: substances and preparations which in very low quantities cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin;
(g) toxic substances and preparations: substances and preparations which in low quantities cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin;
(h) harmful substances and preparations: substances and preparations which may cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin;
(i) corrosive substances and preparations: substances and preparations which may, on contact with living tissues, destroy them;
(j) irritant substances and preparations: non-corrosive substances and preparations which, through immediate, prolonged or repeated contact with the skin or mucous membrane, may cause inflammation;
(k) sensitising substances and preparations: substances and preparations which, if they are inhaled or if they penetrate the skin, are capable of eliciting a reaction of hypersensitisation such that on further exposure to the substance of preparation, characteristic adverse effects are produced;
(l) carcinogenic substances and preparations: substances or preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce cancer or increase its incidence;
(m) mutagenic substances and preparations: substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce heritable genetic defects or increase their incidence;
(n) substances and preparations which are toxic for reproduction: substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may produce, or increase the incidence of, non-heritable adverse effects in the progeny and/or an impairment of male or female reproductive functions or capacity;
(o) substances and preparations which are dangerous for the environment: substances and preparations which, were they to enter the environment, would or could present an immediate or delayed danger for one or more components of the environment.
Article 3
Determination of dangerous properties of preparations
1. The evaluation of the hazards of a preparation shall be based on the determination of:
- physico-chemical properties,
- properties affecting health,
- environmental properties.
These different properties shall be determined in accordance with the provisions laid down in Articles 5, 6 and 7.
Where laboratory tests are conducted, they shall be carried out on the preparation as placed on the market.
2. Where the determination of dangerous properties is carried out in accordance with Articles 5, 6 and 7, all dangerous substances within the meaning of Article 2 and in particular those which:
- are listed in Annex I to Directive 67/548/EEC,
- are listed in Elincs in accordance with Article 21 of Directive 67/548/EEC,
- are classified and labelled provisionally by the person responsible for the placing on the market in accordance with Article 6 of Directive 67/548/EEC,
- are classified and labelled in accordance with Article 7 of Directive 67/548/EEC and are not yet included in Elincs,
- are covered by Article 8 of Directive 67/548/EEC,
- are classified and labelled in accordance with Article 13 of Directive 67/548/EEC,
shall be taken into consideration in accordance with the provisions laid down in the method used.
3. For preparations covered by this Directive, dangerous substances as referred to in paragraph 2 which are classified as dangerous on the basis of their health and/or environmental effects, whether they are present as impurities or additives, shall be taken into consideration when their concentrations are equal to, or greater than, those defined in the following table unless lower values are given in Annex I to Directive 67/548/EEC, or in Part B of Annex II to this Directive or in Part B of Annex III thereto, unless otherwise specified in Annex V to this Directive.
>TABLE>
Article 4
General principles of classification and labelling
1. The classification of dangerous preparations according to the degree and specific nature of the hazards involved shall be based on the definitions of categories of danger laid down in Article 2.
2. The general principles of the classification and labelling of preparations shall be applied in accordance with the criteria laid down in Annex VI to Directive 67/548/EEC, save where alternative criteria referred to in Article 5, 6, 7 or 10 and the relevant Annexes of this Directive are applied.
Article 5
Evaluation of the hazards deriving from physico-chemical properties
1. The hazards of a preparation deriving from its physico-chemical properties shall be assessed by determining, by means of the methods specified in Part A of Annex V to Directive 67/548/EEC, the physico-chemical properties of the preparation necessary for appropriate classification and labelling in accordance with the criteria laid down in Annex VI to that Directive.
2. By way of derogation from paragraph 1:
the determination of the explosive, oxidising, extremely flammable, highly flammable, or flammable properties is not necessary provided that:
- none of the constituents possesses such properties and that, on the basis of the information available to the manufacturer, the preparation is unlikely to present hazards of this kind,
- in the event of a change in the composition of a preparation of known composition, scientific evidence indicates that a reassessment of the hazards will not lead to a change in classification,
- preparations placed on the market in the form of aerosols satisfy the provisions of Article 9a of Directive 75/324/EEC(17).
3. For certain cases for which the methods laid down in Part A of Annex V to Directive 67/548/EEC are not appropriate, alternative calculation methods are laid down in Part B of Annex I to this Directive.
4. Certain exemptions from the application of the methods laid down in Part A of Annex V to Directive 67/548/EEC are referred to in Part A of Annex I to this Directive.
5. The hazards deriving from the physico-chemical properties of a preparation covered by Directive 91/414/EEC shall be assessed by determining the physico-chemical properties of the preparation necessary for appropriate classification in accordance with the criteria set out in Annex VI to Directive 67/548/EEC. These properties shall be determined by means of the methods laid down in Part A of Annex V to Directive 67/548/EEC unless other internationally recognised methods are acceptable in accordance with the provisions of Annexes II and III to Directive 91/414/EEC.
Article 6
Evaluation of health hazards
1. The health hazards of a preparation shall be assessed by one or more of the following procedures:
(a) by a conventional method described in Annex II;
(b) by determining the toxicological properties of the preparation necessary for appropriate classification in accordance with the criteria in Annex VI to Directive 67/548/EEC. These properties shall be determined by means of the methods laid down in Part B of Annex V to Directive 67/548/EEC, unless, in the case of plant protection products, other internationally recognised methods are acceptable in accordance with the provisions of Annexes II and III to Directive 91/414/EEC.
2. Without prejudice to the requirements of Directive 91/414/EEC, only where it can be scientifically demonstrated by the person responsible for placing the preparation on the market that the toxicological properties of the preparation cannot correctly be determined by the method outlined in paragraph 1(a), or on the basis of existing test results on animals, the methods outlined in paragraph 1(b) may be used, provided they are justified or specifically authorised under Article 12 of Directive 86/609/EEC.
When a toxicological property is established by the methods outlined in paragraph 1(b) to obtain new data, the test shall be conducted in compliance with the principles of good laboratory practice provided for in Council Directive 87/18/EEC of 18 December 1986 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances(18) and the provisions of Directive 86/609/EEC, in particular Articles 7 and 12 thereof.
Subject to the provisions of paragraph 3, where a toxicological property has been established on the basis of both the methods outlined in paragraphs 1(a) and (b), the results from the methods outlined in paragraph 1(b) shall be used for classifying the preparation, except in the case of carcinogenic, mutagenic or toxic effects for reproduction for which only the method outlined in 1(a) shall be used.
Any of the toxicological properities of the preparation which are not assessed by the method outlined in paragraph 1(b) shall be assessed in accordance with the method outlined in paragraph 1(a).
3. Furthermore, where it can be demonstrated:
- by epidemiological studies, by scientifically valid case studies as specified by Annex VI to Directive 67/548/EEC or by statistically backed experience, such as the assessment of data from poison information units or concerning occupational diseases, that toxicological effects on man differ from those suggested by the application of the methods outlined in paragraph 1, then the preparation shall be classified according to its effects on man,
- that, owing to effects such as potentiation, a conventional assessment would underestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation,
- that, owing to effects such as antagonism, a conventional assessment would overestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation.
4. For preparations of a known composition, with the exception of those covered by Directive 91/414/EEC, classified in accordance with paragraph 1(b), a new evaluation of health hazard by the methods outlined in either paragraph 1(a) or (b) shall be performed whenever:
-
>TABLE>
- changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the meaning of the definitions set out in Article 2, are introduced by the manufacturer.
This new evaluation will apply unless there is valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification.
Article 7
Evaluation of environmental hazards
1. The hazards of a preparation for the environment shall be assessed by one or more of the following procedures:
(a) by a conventional method described in Annex III to this Directive;
(b) by determining the hazardous properties of the preparation for the environment necessary for appropriate classification in accordance with the criteria set out in Annex VI to Directive 67/548/EEC. These properties shall be determined by means of the methods laid down in Part C of Annex V to Directive 67/548/EEC unless, in the case of plant protection products, other internationally recognised methods are acceptable in accordance with the provisions of Annexes II and III to Directive 91/414/EEC. Without prejudice to the testing requirements set out in Directive 91/414/EEC, the conditions for application of the test methods are described in Part C of Annex III to this Directive.
2. Where an ecotoxicological property is established by one of the methods outlined in paragraph 1(b) to obtain new data, the test shall be conducted in compliance with the principles of good laboratory practice provided for in Directive 87/18/EEC and with the provisions of Directive 86/609/EEC.
Where the environmental hazards have been assessed in compliance with both the procedures mentioned above, the results of the methods referred to in paragraph 1(b) shall be used for classifying the preparation.
3. For preparations of a known composition, with the exception of those covered by Directive 91/414/EEC, classified in accordance with the method outlined in paragraph 1(b), a new evaluation of environmental hazard either by the method outlined in paragraph 1(a) or that outlined in paragraph 1(b) shall be performed whenever:
-
>TABLE>
- changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the meaning of the definitions set out in Article 2, are introduced by the manufacturer.
This new evaluation will apply unless there is valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification.
Article 8
Obligations and duties of the Member States
1. Member States shall take all necessary measures to ensure that the preparations covered by this Directive cannot be placed on the market unless they comply with it.
2. In order to ensure compliance with this Directive, the authorities of the Member States may request information on the composition of the preparation and any other pertinent information from any person responsible for placing the preparation on the market.
3. Member States shall take all necessary measures to ensure that those responsible for placing the preparation on the market hold at the disposal of the authorities of the Member States:
- the data used for the classification and labelling of the preparation,
- any pertinent information relating to packaging requirements in accordance with Article 9(1.3), including the test certificate issued in accordance with Part A of Annex IX to Directive 67/548/EEC,
- the data used for establishing the safety data sheet, in accordance with Article 14.
4. Member States and the Commission shall exchange information concerning the name and full address of the national authority (authorities) responsible for communicating and exchanging information relating to the practical application of this Directive.
Article 9
Packaging
1. Member States shall take all necessary measures to ensure that:
1.1. preparations within the meaning of Article 1(2) and preparations covered by Annex IV pursuant to Article 1(3) cannot be placed on the market unless their packaging satisfies the following requirements:
- it shall be so designed and constructed that its contents cannot escape; this requirement shall not apply where special safety devices are prescribed,
- the materials constituting the packaging and fastenings must not be susceptible to adverse attack by the contents, or liable to form dangerous compounds with the contents,
- packaging and fastenings must be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling,
- containers fitted with replaceable fastening devices shall be so designed that the packaging can be refastened repeatedly without the contents escaping;
1.2. containers which contain preparations within the meaning of Article 1(2) and preparations covered by Annex IV pursuant to Article 1(3) offered or sold to the general public do not have:
- either a shape and/or graphic decoration likely to attract or arouse the active curiosity of children or to mislead consumers, or
- a presentation and/or a designation used for foodstuffs or animal feedingstuffs or medicinal or cosmetic products.
1.3. containers which contain certain preparations offered or sold to the general public covered by Annex IV to this Directive:
- are fitted with child-resistant fastenings,
and/or
- carry a tactile warning of danger.
The devices must conform to the technical specifications given in Parts A and B of Annex IX to Directive 67/548/EEC.
2. The packaging of preparations shall be deemed to satisfy the requirements of paragraph 1.1, first, second and third indents, if it complies with the requirements for carriage of dangerous goods by rail, road, inland waterway, sea or air.
Article 10
Labelling
1.1. Member States shall take all necessary measures to ensure that:
(a) preparations within the meaning of Article 1(2) cannot be placed on the market unless the labelling on their packaging satisfies all the requirements of this Article and the specific provisions of Part A and B of Annex V;
(b) preparations within the meaning of Article 1(3) as defined in Parts B and C of Annex V cannot be placed on the market unless the labelling on their packaging satisfies the requirements of paragraphs 2.1 and 2.2 and the specific provisions of Parts B and C of Annex V.
1.2. With respect to plant protection products subject to Directive 91/414/EEC, the labelling requirements in accordance with this Directive shall be accompanied by the following wording: "To avoid risks to man and the environment, comply with the instructions for use."
This labelling shall be without prejudice to the information required in accordance with Article 16 of, and Annex V to, Directive 91/414/EEC.
2. The following information shall be clearly and indelibly marked on any package:
2.1. the trade name or designation of the preparation;
2.2. the name, full address and telephone number of the person established in the Community who is responsible for placing the preparation on the market, whether it be the manufacturer, the importer or the distributor;
2.3. the chemical name of the substance or substances present in the preparation in accordance with the following detailed rules:
2.3.1. for preparations classified T+, T, Xn in accordance with Article 6, only the substances T+, T, Xn present in concentrations equal to, or greater than, the lowest limit (limit Xn) for each of them laid down in Annex I to Directive 67/548/EEC or, failing that, Part B of Annex II to this Directive have to be taken into consideration;
2.3.2. for preparations classified C in accordance with Article 6, only C substances present in concentrations equal to, or greater than, the lowest limit (limit Xi) laid down in Annex I to Directive 67/548/EEC or, failing that, Part B of Annex II to this Directive have to be taken into consideration;
2.3.3. the name of the substances which have given rise to the classification of the preparation in one or more of the following danger categories:
- carcinogen category 1, 2 or 3,
- mutagen category 1, 2 or 3,
- toxic for reproduction category 1, 2 or 3,
- very toxic, toxic or harmful due to non-lethal effects after a single exposure,
- toxic or harmful due to severe effects after repeated or prolonged exposure,
- sensitising;
shall be mentioned on the label.
The chemical name shall be one of the designations listed in Annex I to Directive 67/548/EEC or an internationally recognised chemical nomenclature if no corresponding designation is yet listed in that Annex.
2.3.4. As a consequence of the above provisions the name of any substance which led to the classification of the preparation in the following danger categories:
- explosive,
- oxidising,
- extremely flammable,
- highly flammable,
- flammable,
- irritant,
- dangerous for the environment,
need not be mentioned on the label unless the substance has to be mentioned pursuant to paragraphs 2.3.1, 2.3.2 or 2.3.3.
2.3.5. As a general rule, a maximum of four chemical names shall suffice to identify the substances primarily responsible for the major health hazards which have given rise to the classification and the choice of the corresponding phrases referring to the risk involved. In some cases, more than four chemical names may be necessary.
2.4. The danger symbol(s) and indication(s) of danger
The danger symbols, where specified in this Directive, and indications of the dangers involved in the use of the preparation, shall be in accordance with the wording of Annexes II and VI to Directive 67/548/EEC and shall be applied in accordance with the evaluation of the hazards carried out in accordance with Annexes I, II and III to this Directive.
Where more than one danger symbol must be assigned to a preparation the obligation to apply the symbol:
- T shall make the symbols C and X optional unless otherwise specified in Annex I to Directive 67/548/EEC,
- C shall make the symbol X optional,
- E shall make the symbols F and O optional,
- Xn shall make the symbol Xi optional.
The symbol(s) shall be printed in black on an orange-yellow background.
2.5. The risk phrases (R phrases)
The indications concerning special risks (R phrases) shall comply with the wording in Annexes III and VI to Directive 67/548/EEC and shall be assigned in accordance with the results of the hazard evaluation carried out in accordance with Annexes I, II, and III to this Directive.
As a general rule, a maximum of six R phrases shall suffice to describe the risks; for this purpose, the combined phrases listed in Annex III to Directive 67/548/EEC shall be regarded as single phrases. However, if the preparation falls within more than one danger category, those standard phrases shall cover all the principal hazards associated with the preparation. In some cases more than six R phrases may be necessary.
The standard phrases "extremely flammable" or "highly flammable" need not be used where they describe an indication of danger used in accordance with 2.4.
2.6. The safety advice (S phrases)
The indications giving safety advice (S phrases) shall comply with the wording in Annex IV and with Annex VI to Directive 67/548/EEC and shall be assigned in accordance with the results of the hazard evaluation carried out in accordance with Annexes I, II and III to this Directive.
As a general rule, a maximum of six S phrases shall suffice to formulate the most appropriate safety advice; for this purpose the combined phrases listed in Annex IV to Directive 67/548/EEC shall be regarded as single phrases. However, in some cases more than six S phrases may be necessary.
Where it is physically impossible to include the advice on the label or package itself, the package shall be accompanied by safety advice on the use of the preparation.
2.7. The nominal quantity (nominal mass or nominal volume) of the contents in the case of preparations offered or sold to the general public.
3. For certain preparations classified as dangerous within the meaning of Article 7, by way of derogation from paragraphs 2.4, 2.5, and 2.6 of this Article, exemptions to certain provisions on environmental labelling or specific provisions in relation to environmental labelling may be determined in accordance with the procedure referred to in Article 20, where it can be demonstrated that there would be a reduction in the environmental impact. These exemptions or specific provisions are defined and laid down in Part A or B of Annex V.
4. If the contents of the package do not exceed 125 ml:
- in the case of preparations that are classified as highly flammable, oxidising, irritant, with the exception of those assigned R41, or dangerous for the environment and assigned the N symbol it shall not be necessary to indicate the R phrases or the S phrases,
- in the case of preparations that are classified as flammable or dangerous for the environment and not assigned the N symbol it shall be necessary to indicate the R phrases but it shall not be necessary to indicate the S phrases.
5. Without prejudice to Article 16(4) of Directive 91/414/EC, indications such as "non-toxic", "non-harmful", "non-polluting", "ecological" or any other statement indicating that the preparation is not dangerous or likely to lead to underestimation of the dangers of the preparation in question shall not appear on the packaging or labelling of any preparation subject to this Directive.
Article 11
Implementation of the labelling requirements
1. Where the particulars required by Article 10 appear on a label, that label shall be firmly affixed to one or more surfaces of the packaging so that those particulars can be read horizontally when the package is set down normally. The dimensions of the label are laid down in Annex VI to Directive 67/548/EEC and the label is intended solely for provision of the information required by this Directive and if necessary of any supplementary health or safety information.
2. A label shall not be required when the particulars are clearly shown on the package itself, as specified in paragraph 1.
3. The colour and presentation of the label - or, in the case of paragraph 2, of the package - shall be such that the danger symbol and its background stand out clearly from it.
4. The information required on the label under Article 10 shall stand out clearly from its background and shall be of such size and spacing as to be easily read.
Specific provisions regarding the presentation and format of this information shall be laid down in Annex VI to Directive 67/548/EEC.
5. Member States may make the placing on the market of preparations covered by this Directive within their territories subject to use of their official language or languages in respect of the labelling thereof.
6. For the purposes of this Directive, labelling requirements shall be deemed to be satisfied:
(a) in the case of an outer package containing one or more inner packages, if the outer package is labelled in accordance with international rules on the transport of dangerous goods and the inner package or packages are labelled in accordance with this Directive;
(b) in the case of a single package:
- if such a package is labelled in accordance with international rules on the transport of dangerous goods and with Article 10(2.1), (2.2), (2.3), (2.5) and (2.6); for preparations classified according to Article 7, the provisions of Article 10(2.4) shall additionally apply with respect to the property in question when it has not been so identified on the label, or
- where appropriate, for particular types of packaging such as mobile gas cylinders, if the specific requirements referred to in Annex VI to Directive 67/548/EEC are complied with.
Where dangerous preparations do not leave the territory of a Member State, labelling may be permitted which complies with national rules instead of with international rules on the transport of dangerous goods.
Article 12
Exemptions from the labelling and packaging requirements
1. Articles 9, 10 and 11 shall not apply to explosives placed on the market with a view to obtaining an explosive or pyrotechnic effect.
2. For certain dangerous preparations within the meaning of Article 5, 6 or 7 defined in Annex VII which, in the form in which they are placed on the market, do not present any physico-chemical risk, or risk to health or to the environment, Articles 9, 10 and 11 shall not apply.
3. Member States may also:
(a) permit the labelling required by Article 10 to be applied in some other appropriate manner on packages which are either too small or otherwise unsuitable for labelling in accordance with Article 11(1) and (2);
(b) by way of derogation from Articles 10 and 11 permit the packaging of dangerous preparations which are classified as harmful, extremely flammable, highly flammable, flammable, irritant or oxidising to be unlabelled or to be labelled in some other way, if they contain such small quantities that there is no reason to fear any danger to persons handling such preparations or to other persons;
(c) by way of derogation from Articles 10 and 11, for preparations classified according to Article 7, permit the packaging of dangerous preparations to be unlabelled or labelled in some other way if they contain such small quantities that there is no reason to fear any dangers to the environment;
(d) by way of derogation from Articles 10 and 11 permit the packaging of dangerous preparations which are not mentioned in (b) or (c) above to be labelled in some other appropriate way, if the packages are too small for the labelling provided for in Articles 10 and 11 and there is no reason to fear any danger to persons handling such preparations or to other persons.
Where this paragraph is applied, the use of symbols, indications of danger, risk (R) phrases or safety (S) phrases different to those laid down in this Directive shall not be permitted.
4. If a Member State makes use of the options provided for in paragraph 3, it shall forthwith inform the Commission and Member States thereof. Where it is appropriate, measures shall be decided upon in the framework of Annex V and in accordance with the provisions of Article 20.
Article 13
Distance selling
Any advertisement for a preparation within the meaning of this Directive which enables a member of the general public to conclude a contract for purchase without first having sight of the label for that preparation must make mention of the type or types of hazard indicated on the label. This requirement is without prejudice to Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts(19).
Article 14
Safety data sheet
1. The safety data sheet information is principally intended for use by professional users and must enable them to take the necessary measures as regards the protection of health, safety and the environment at the place of work.
2.1. Member States shall take all the necessary measures to ensure that:
(a) the person responsible for placing on the market a preparation within the meaning of Article 1(2) provides a safety data sheet;
(b) the person responsible for placing on the market a preparation provides on request of a professional user a safety data sheet providing proportionate information for preparations not classified as dangerous within the meaning of Articles 5, 6 and 7 but containing in an individual concentration of >= 1 % by weight for non-gaseous preparations and >= 0,2 % by volume for gaseous preparations at least:
- one substance posing health or environmental hazards, or
- one substance for which there are Community workplace exposure limits.
2.2. The safety data sheet and its supply must comply with the provisions of Directive 91/155/EEC.
2.3. The necessary amendments required to adapt to technical progress Directive 91/155/EEC shall be adopted in accordance with the procedure laid down in Article 20 of this Directive.
In particular, the necessary amendments to take account of provisions in paragraph 2.1(b) shall be adopted before the date specified in Article 22(1).
2.4. The safety data sheet may be supplied on paper or electronically, provided that the addressee has the necessary means of receiving it.
Article 15
Confidentiality of chemical names
Where the person responsible for placing the preparation on the market can demonstrate that the disclosure on the label or safety data sheet of the chemical identity of a substance which is exclusively classified as:
- irritant with the exception of those assigned R41 or irritant in combination with one or more of the other properties mentioned in point 2.3.4 of Article 10, or
- harmful or harmful in combination with one or more of the properties mentioned in point 2.3.4 of Article 10 presenting acute lethal effects alone
will put at risk the confidential nature of his intellectual property, he may, in accordance with the provisions of Annex VI, be permitted to refer to that substance either by means of a name that identifies the most important functional chemical groups or by means of an alternative name. This procedure may not be applied where the substance concerned has been assigned a Community exposure limit.
Where the person responsible for placing a preparation on the market wishes to take advantage of confidentiality provisions, he shall make a request to the competent authority of the Member State in which the preparation is to be first placed on the market.
This request must be made in accordance with the provisions of Annex VI and must provide the information required in the form in Part A of that Annex. The competent authority may nevertheless request further information from the person responsible for placing the preparation on the market if such information appears necessary in order to evaluate the validity of the request.
The authority of the Member State receiving a request for confidentiality shall notify the applicant of its decision. The person responsible for placing the preparation on the market shall forward a copy of this decision to each of the Member States where he wishes to market the product.
Confidential information brought to the attention of the authorities of a Member State or of the Commission shall be treated in accordance with Article 19(4) of Directive 67/548/EEC.
Article 16
Rights of Member States regarding safety of workers
This Directive shall not affect the right of Member States to specify, in compliance with the Treaty, the requirements they deem necessary to ensure that workers are protected when using the dangerous preparations in question, provided that this does not mean that the classification, packaging, and labelling of dangerous preparations are modified in a way not provided for in this Directive.
Article 17
Bodies responsible for receiving information relating to health
Member States shall appoint the body or bodies responsible for receiving information, including chemical composition, relating to preparations placed on the market and considered dangerous on the basis of their health effects or on the basis of their physico-chemical effects.
Member States shall take the necessary steps to ensure that the appointed bodies provide all the requisite guarantees for maintaining the confidentiality of the information received. Such information may only be used to meet any medical demand by formulating preventive and curative measures, in particular in case of emergency.
Member States shall ensure that the information is not used for other purposes.
Member States shall ensure that the appointed bodies have at their disposal all the information required from the manufacturers or persons responsible for marketing to carry out the tasks for which they are responsible.
Article 18
Free movement clause
Without prejudice to the provisions set out in other Community legislation, Member States may not prohibit, restrict or impede the placing on the market of preparations because of their classification, packaging, labelling or safety data sheets if such preparations comply with the provisions laid down in this Directive.
Article 19
Safeguard clause
1. Where a Member State has detailed evidence that a preparation, although satisfying the provisions of this Directive, constitutes a hazard for man or the environment on grounds relating to the provisions of this Directive, it may provisionally prohibit the placing on the market of that preparation or subject it to special conditions in its territory. It shall immediately inform the Commission and the other Member States of such action and give reasons for its decision.
2. In the case referred to in paragraph 1, the Commission shall consult the Member States as soon as possible.
3. The Commission shall take a decision in accordance with the procedure laid down in Article 20.
Article 20
Adaptation to technical progress
Amendments required to adapt the Annexes to this Directive to technical progress shall be adopted in accordance with the procedure laid down in Article 29(4)(a) of Directive 67/548/EEC.
The Commission shall be assisted by a committee composed of the representatives of the Member States and chaired by the representative of the Commission.
The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 205(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.
If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If the Council has not acted within three months of the date of referral, the proposed measures shall be adopted by the Commission.
Article 21
Repeal of Directives
1. The Directives listed in Part A of Annex VIII are hereby repealed, without prejudice to the obligation of the Member States concerning the deadlines for transposition into national law and for application of the Directives indicated in Part B of Annex VIII.
2. The Directives listed in Part A of Annex VIII shall apply to Austria, Finland and Sweden subject to provisions laid down in Part C of that Annex and pursuant to the Treaty.
3. References to the repealed Directives shall constitute references to this Directive and should be read in accordance with the correlation table set out in Annex IX.
Article 22
Transposition
1. Member States shall adopt and publish before 30 July 2002 the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.
2. Member States shall apply the laws, regulations and administrative provisions referred to in paragraph 1:
(a) to preparations not within the scope of Directive 91/414/EEC or Directive 98/8/EC as from 30 July 2002; and
(b) to preparations within the scope of Directive 91/414/EEC or Directive 98/8/EC as from 30 July 2004.
3. When Member States adopt such measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such reference shall be laid down by Member States.
Article 23
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 21(2) shall apply from 1 January 1999.
Article 24
Addressees
This Directive is addressed to the Member States.
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[
"UKSI20021689"
] |
31999L0041
|
1999
|
Directive 1999/41/EC of the European Parliament and of the Council of 7 June 1999 amending Directive 89/398/EEC on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), in the light of the joint text approved by the Conciliation Committee on 18 March 1999,
(1) Whereas Article 4 of Directive 89/398/EEC(4) provides that specific provisions applicable to the groups of foods appearing in Annex I thereto are to be laid down by means of specific Directives;
(2) Whereas to date specific Directives have been adopted for infant formulae and follow-on formulae(5), for processed cereal-based foods and baby foods intended for infants and young children(6) and for foods intended for use in energy-restricted diets for weight reduction(7); whereas there are reasons relating to public health for adopting specific provisions, in accordance with Article 4 of Directive 89/398/EEC, for dietary foods for special medical purposes and foods intended to meet the expenditure of intense muscular effort, especially for sportsmen, as referred to in Annex I to that Directive;
(3) Whereas, in the case of the groups of low-sodium foods, including low-sodium or sodium-free dietary salts, and gluten-free foods, such products can be satisfactorily placed on the market and be efficiently monitored officially under the general provisions of Directive 89/398/EEC, provided that the conditions for the use of certain terms used to indicate the paticular nutritional properties of products are defined;
(4) Whereas the deletion of those categories from Annex I to Directive 89/398/EEC would be in line with the efforts being made to avoid unnecessarily detailed legislation;
(5) Whereas it is not clear whether an adequate basis exists for specific provisions to be adopted for the group mentioned in point 9 of Annex I to Directive 89/398/EEC, namely the group of foods intended for persons suffering from carbohydrate-metabolism disorders (diabetes);
(6) Whereas therefore advice should be obtained from, inter alia, the Scientific Committee for Food before a final decision is taken on the question;
(7) Whereas it is still possible to harmonize at Community level rules applicable to other groups of foodstuffs for particular nutritional uses, in the interest of consumer protection and the free movement of such foodstuffs,
Article 1
Directive 89/398/EEC is hereby amended as follows:
1. The following Articles shall be inserted: "Article 4a
Rules for the use of terms concerning
- the reduction or absence of sodium or salt (sodium chloride, table salt) content,
- the absence of gluten,
which may be used to describe the products referred to in Article 1, shall be adopted in accordance with the procedure laid down in Article 13.
Article 4b
Before 8 July 2002, the Commission shall, after consulting the Scientific Committee for Food, present to the European Parliament and to the Council a report on the desirability of special provisions for foods for persons suffering from carbohydrate-metabolism discorders (diabetes).
In the light of the conclusions of this report, the Commission shall either, in accordance with the procedure laid down in Article 13, proceed with the preparation of the special provisions concerned or shall present, in accordance with the procedure laid down in Article 95 of the Treaty, any appropriate proposals for amendments to this Directive."
2. Article 9(5) shall be replaced by the following: "5. Before 8 July 2002 and every three years thereafter, the Commission shall send the European Parliament and the Council a report on the implementation of this Article."
3. Annex I shall be replaced by the following:
"ANNEX I
- Groups of foodstuffs for particular nutritional uses for which specific provisions will be laid down by specific Directives:(1)
1. Infant formulae and follow-on formulae
2. Processed cereal-based foods and baby foods for infants and young children
3. Food intended for use in energy-restricted diets for weight reduction
4. Dietary foods for special medical purposes
5. Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen;
- Groups of foodstuffs for particular nutritional uses for which specific provisions will be laid down by a specific Directive(2), dependant on the outcome of the procedure described in Article 4b:
6. Foods for persons suffering from carbohydrate-metabolism disorders (diabetes).
(1) It is understod that products already on the market when Directive is adopted will not be affected by it.
(2) It is understod that products already on the market when Directive is adopted will not be affected by it."
Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive not later than 8 July 1999. They shall forthwith inform the Commission thereof.
These measures shall be applied in such a way as to:
- permit trade in products complying with this Directive by 8 July 2000;
- prohibit trade in products not complying with this Directive by 8 January 2001
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 3
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20020333"
] |
31999L0063
|
1999
|
Council Directive 1999/63/EC of 21 June 1999 concerning the Agreement on the organisation of working time of seafarers concluded by the European Community Shipowners' Association (ECSA) and the Federation of Transport Workers' Unions in the European Union (FST) - Annex: European Agreement on the organisation of working time of seafarers
Having regard to the Treaty establishing the European Community, and, in particular Article 139(2) thereof,
Having regard to the proposal from the Commission,
Whereas:
(1) following the entry into force of the Treaty of Amsterdam, the provisions of the Agreement on social policy annexed to the Protocol 14 on social policy, annexed to the Treaty establishing the European Community, as amended by the Treaty of Maastricht, have been incorporated into Articles 136 to 139 of the Treaty establishing the European Community;
(2) management and labour ("the social partners"), may in accordance with Article 139(2) of the Treaty, request jointly that agreements at Community level be implemented by a Council decision on a proposal from the Commission;
(3) the Council adopted Directive 93/104/EC of 23 November 1993 concerning certain aspects of the organisation of working time(1); whereas sea transport was one of the sectors of activity excluded from the scope of that Directive;
(4) account should be taken of the relevant Conventions of the International Labour Organisation with regard to the organisation of working time, including in particular those relating to the hours of work of seafarers;
(5) the Commission, in accordance with Article 3(2) of the Agreement on social policy, has consulted management and labour on the possible direction of Community action with regard to the sectors and activities excluded from Directive 93/104/EC;
(6) after that consultation the Commission considered that Community action was desirable in that area, and once again consulted management and labour at Community level on the substance of the envisaged proposal in accordance with Article 3(3) of the said Agreement;
(7) the European Community Shipowners' Association (ECSA) and the Federation of Transport Workers' Unions in the European Union (FST) informed the Commission of their desire to enter into negotiations in accordance with Article 4 of the Agreement on social policy;
(8) the said organisations concluded, on 30 September 1998, an Agreement on the working time of seafarers; this Agreement contains a joint request to the Commission to implement the Agreement by a Council decision on a proposal from the Commission, in accordance with Article 4(2) of the Agreement on social policy;
(9) the Council, in its resolution of 6 December 1994 on certain aspects for a European Union social policy: a contribution to economic and social convergence in the Union(2) asked management and labour to make use of the opportunities for concluding agreements, since they are close to social reality and to social problems;
(10) the Agreement applies to seafarers on board every seagoing ship, whether publicly or privately owned, which is registered in the territory of any Member State and is ordinarily engaged in commercial maritime operations;
(11) the proper instrument for implementing the Agreement is a Directive within the meaning of Article 249 of the Treaty; it therefore binds the Member States as to the result to be achieved, whilst leaving national authorities the choice of form and methods;
(12) in accordance with the principles of subsidiarity and proportionality as set out in Article 5 of the Treaty, the objectives of this Directive cannot be sufficiently achieved by the Member States and can therefore be better achieved by the Community; this Directive does not go beyond what is necessary for the attainment of those objectives;
(13) with regard to terms used in the Agreement which are not specifically defined therein, this Directive leaves Member States free to define those terms in accordance with national law and practice, as is the case for other social policy Directives using similar terms, providing that those definitions respect the content of the Agreement;
(14) the Commission has drafted its proposal for a Directive, in accordance with its communication of 20 May 1998 on adapting and promoting the social dialogue at Community level, taking into account the representative status of the signatory parties and the legality of each clause of the Agreement;
(15) the Commission informed the European Parliament and the Economic and Social Committee, in accordance with its communication of 14 December 1993 concerning the application of the Agreement on social policy, by sending them the text of its proposal for a Directive containing the Agreement;
(16) the implementation of the Agreement contributes to achieving the objectives under Article 136 of the Treaty,
Article 1
The purpose of this Directive is to put into effect the Agreement on the organisation of working time of seafarers concluded on 30 September 1998 between the organisations representing management and labour in the maritime sector (ECSA and FST) as set out in the Annex hereto.
Article 2
Minimum requirements
1. Member States may maintain or introduce more favourable provisions than those laid down in this Directive.
2. The implementation of this Directive shall under no circumstances constitute sufficient grounds for justifying a reduction in the general level of protection of workers in the fields covered by this Directive. This shall be without prejudice to the rights of Member States and/or management and labour to lay down, in the light of changing circumstances, different legislative, regulatory or contractual arrangements to those prevailing at the time of the adoption of this Directive, provided always that the minimum requirements laid down in this Directive are adhered to.
Article 3
Transposition
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 2002, or shall ensure that, by that date at the latest, management and labour have introduced the necessary measures by agreement, the Member States being required to take any necessary measure to enable them at any time to be in a position to guarantee the results imposed by this Directive. They shall forthwith inform the Commission thereof.
2. When Member States adopt the provisions referred to in the first paragraph, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such reference shall be laid down by the Member States.
Article 4
Addressees
This Directive is addressed to the Member States.
|
[
"UKSI20022055",
"UKSI20022125"
] |
31999L0070
|
1999
|
Council Directive 1999/70/EC of 28 June 1999 concerning the framework agreement on fixed-term work concluded by ETUC, UNICE and CEEP
Having regard to the Treaty establishing the European Community, and in particular Article 139(2) thereof,
Having regard to the proposal from the Commission,
Whereas:
(1) Following the entry into force of the Treaty of Amsterdam the provisions of the Agreement on social policy annexed to the Protocol on social policy, annexed to the Treaty establishing the European Community have been incorporated into Articles 136 to 139 of the Treaty establishing the European Community;
(2) Management and labour (the social partners) may, in accordance with Article 139(2) of the Treaty, request jointly that agreements at Community level be implemented by a Council decision on a proposal from the Commission;
(3) Point 7 of the Community Charter of the Fundamental Social Rights of Workers provides, inter alia, that "the completion of the internal market must lead to an improvement in the living and working conditions of workers in the European Community. This process must result from an approximation of these conditions while the improvement is being maintained, as regards in particular forms of employment other than open-ended contracts, such as fixed-term contracts, part-time working, temporary work and seasonal work";
(4) The Council has been unable to reach a decision on the proposal for a Directive on certain employment relationships with regard to distortions of competition(1), nor on the proposal for a Directive on certain employment relationships with regard to working conditions(2);
(5) The conclusions of the Essen European Council stressed the need to take measures with a view to "increasing the employment-intensiveness of growth, in particular by a more flexible organisation of work in a way which fulfils both the wishes of employees and the requirements of competition";
(6) The Council Resolution of 9 February 1999 on the 1999 Employment Guidelines invites the social partners at all appropriate levels to negotiate agreements to modernise the organisation of work, including flexible working arrangements, with the aim of making undertakings productive and competitive and achieving the required balance between flexibility and security;
(7) The Commission, in accordance with Article 3(2) of the Agreement on social policy, has consulted management and labour on the possible direction of Community action with regard to flexible working time and job security;
(8) The Commission, considering after such consultation that Community action was desirable, once again consulted management and labour on the substance of the envisaged proposal in accordance with Article 3(3) of the said Agreement;
(9) The general cross-industry organisations, namely the Union of Industrial and Employers' Confederations of Europe (UNICE), the European Centre of Enterprises with Public Participation (CEEP) and the European Trade Union Confederation (ETUC), informed the Commission in a joint letter dated 23 March 1998 of their desire to initiate the procedure provided for in Article 4 of the said Agreement; they asked the Commission, in a joint letter, for a further period of three months; the Commission complied with this request extending the negotiation period to 30 March 1999;
(10) The said cross-industry organisations on 18 March 1999 concluded a framework agreement on fixed-term work; they forwarded to the Commission their joint request to implement the framework agreement by a Council Decision on a proposal from the Commission, in accordance with Article 4(2) of the Agreement on social policy;
(11) The Council, in its Resolution of 6 December 1994 on "certain aspects for a European Union social policy: a contribution to economic and social convergence in the Union"(3), asked management and labour to make use of the opportunities for concluding agreements, since they are as a rule closer to social reality and to social problems;
(12) The signatory parties, in the preamble to the framework agreement on part-time work concluded on 6 June 1997, announced their intention to consider the need for similar agreements relating to other forms of flexible work;
(13) Management and labour wished to give particular attention to fixed-term work, while at the same time indicating that it was their intention to consider the need for a similar agreement relating to temporary agency work;
(14) The signatory parties wished to conclude a framework agreement on fixed-term work setting out the general principles and minimum requirements for fixed-term employment contracts and employment relationships; they have demonstrated their desire to improve the quality of fixed-term work by ensuring the application of the principle of non-discrimination, and to establish a framework to prevent abuse arising from the use of successive fixed-term employment contracts or relationships;
(15) The proper instrument for implementing the framework agreement is a directive within the meaning of Article 249 of the Treaty; it therefore binds the Member States as to the result to be achieved, whilst leaving them the choice of form and methods;
(16) In accordance with the principles of subsidiarity and proportionality as set out in Article 5 of the Treaty, the objectives of this Directive cannot be sufficiently achieved by the Member States and can therefore be better achieved by the Community; this Directive limits itself to the minimum required for the attainment of those objectives and does not go beyond what is necessary for that purpose;
(17) As regards terms used in the framework agreement but not specifically defined therein, this Directive allows Member States to define such terms in conformity with national law or practice as is the case for other Directives on social matters using similar terms, provided that the definitions in question respect the content of the framework agreement;
(18) The Commission has drafted its proposal for a Directive, in accordance with its Communication of 14 December 1993 concerning the application of the agreement on social policy and its Communication of 20 May 1998 on adapting and promoting the social dialogue at Community level, taking into account the representative status of the contracting parties, their mandate and the legality of each clause of the framework agreement; the contracting parties together have a sufficiently representative status;
(19) The Commission informed the European Parliament and the Economic and Social Committee by sending them the text of the agreement, accompanied by its proposal for a Directive and the explanatory memorandum, in accordance with its communication concerning the implementation of the Protocol on social policy;
(20) On 6 May 1999 the European Parliament adopted a Resolution on the framework agreement between the social partners;
(21) The implementation of the framework agreement contributes to achieving the objectives in Article 136 of the Treaty,
Article 1
The purpose of the Directive is to put into effect the framework agreement on fixed-term contracts concluded on 18 March 1999 between the general cross-industry organisations (ETUC, UNICE and CEEP) annexed hereto.
Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 10 July 1999, or shall ensure that, by that date at the latest, management and labour have introduced the necessary measures by agreement, the Member States being required to take any necessary measures to enable them at any time to be in a position to guarantee the results imposed by this Directive. They shall forthwith inform the Commission thereof.
Member States may have a maximum of one more year, if necessary, and following consultation with management and labour, to take account of special difficulties or implementation by a collective agreement. They shall inform the Commission forthwith in such circumstances.
When Member States adopt the provisions referred to in the first paragraph, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States.
Article 3
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20022034"
] |
31999L0071
|
1999
|
Commission Directive 1999/71/EC of 14 July 1999 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(1), as last amended by Commission Directive 1999/65/EC(2), and in particular Article 10 thereof,
Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin(3), as last amended by Comission Directive 98/82/EC(4), and in particular Article 10 thereof,
Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on products of plant origin, including fruit and vegetables(5), as last amended by Directive 1999/65/EC, and in particular Article 7 thereof,
Having regard to Council Directive 91/414/EEC concerning the placing of plant protection products on the market(6), as last amended by Directive 99/1/EC(7), and in particular Article 4(1) (f) thereof,
(1) Whereas the new active substance, azoxystrobin, was included in Annex I to Directive 91/414/EEC by Commission Directive 98/47/EC(8) for use as fungicide only, but without specifying particular conditions having an impact on crops which may be treated with plant protection products containing azoxystrobin;
(2) Whereas the said inclusion in Annex I was based on assessment of the information submitted concerning proposed use as fungicide on cereals and vines; whereas information relating to uses on cereals, vines and bananas has been submitted by certain Member States in accordance with the requirements of Article 4(1) (f) of Directive 91/414/EEC; whereas the information available has been reviewed and is sufficient to fix certain maximum residue levels;
(3) Whereas where no Community maximum residue level or provisional MRL exists Member States shall establish a national provisional maximum residue level in accordance with Article 4(1) (f) of Directive 91/414/EEC before the authorisation may be granted;
(4) Whereas at the inclusion in Annex I to Directive 91 /414/EEC the technical and scientific evaluation of azoxystrobin was finalised on 22 April 1998 in the format of the Commission review report for azoxystrobin; whereas in this review report the acceptable daily intake (ADI) for azoxystrobin was set at 0.1 mg/kg bw/day; whereas the lifetime exposure of consumers of food products treated with azoxystrobin has been assessed and evaluated in accordance with the procedures and practices used within the European Community, taking account of guidelines published by the World Health Organisation(9) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceedence of this ADI;
(5) Whereas acute toxic effects requiring the setting of an acute reference dose were not noted during the evaluation and discussion which preceded the inclusion of azoxystrobin in Annex I to Directive 91/414/EEC;
(6) Whereas for certain agricultural products the use conditions for azoxystrobin have already been defined in a manner which permits the establishing of definitive maximum residue levels;
(7) Whereas to ensure that the consumer is adequately protected from exposure to residues in or on products for which no authorisations have been granted, it is prudent to set provisional maximum residue levels at the lower limit of analytical determination for all those products covered by Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC; whereas the setting at Community level of such provisional maximum residue levels does not prevent the Member States from establishing provisional maximum residue levels for azoxystrobin in accordance with Article 4(1) (f) of Directive 91/414/EEC and in accordance with Annex VI to Directive 91/414/EEC in particular part B, Section 2.4.2.3 to this Annex; whereas four years is considered a sufficient period of time during which to establish most further uses of azoxystrobin; whereas after that period these provisional maximum residue levels should become definitive;
(8) Whereas the Community's trading partners have been consulted about the levels set out in this Directive through the World Trade Organisation and their comments on these levels have been considered; whereas the possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the Commission on the basis of the submission of acceptable data;
(9) Whereas the opinion of the Scientific Committee for Plants, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides, have been taken into account;
(10) Whereas this Directive is in accordance with the opinion of the Standing Committee on Plant Health,
Article 1
The following pesticide residues shall be added to part A of Annex II to Directive 86/362/EEC:
>TABLE>
Article 2
The following pesticide residues shall be added to part B of Annex II to Directive 86/363/EEC:
>TABLE>
Article 3
The following pesticide residues shall be added to Annex II to Directive 90/642/EEC:
>TABLE>
Article 4
1. For those agricultural products listed in part A of Annex II to Directive 86/362/EEC, and in Annex II to Directive 90/642/EEC where the maximum residue levels for azoxystrobin are indicated as "(p)", this shall mean that they are provisional (p) in accordance with the provisions of Article 4(1) (f) of Directive 91/414/EEC.
2. Four years after the entry into force of this Directive, provisional maximum residue levels for azoxystrobin in the Annexes shall cease to be provisional and shall become definitive in the sense of Article 4(1) of Directives 86/362/EEC and 86/363/EEC or Article 3 of Directive 90/642/EEC respectively.
Article 5
1. This Directive shall enter into force on 1 August 1999.
2. Member States shall adopt and publish the legislative, regulatory or administrative measures to comply with this Directive by 31 January 2000. They shall immediately inform the Commission thereof. These measures shall apply as from 1 February 2000.
3. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 6
This Directive is addressed to the Member States.
|
[
"UKSI19993483"
] |
31999L0074
|
1999
|
Council Directive 1999/74/EC of 19 July 1999 laying down minimum standards for the protection of laying hens
Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the European Parliament(2),
Having regard to the opinion of the Economic and Social Committee(3),
Whereas:
(1) On 7 March 1988 the Council adopted Directive 88/166/EEC(4) complying with the judgment of the Court of Justice in Case 131/86 (annulment of Council Directive 86/113/EEC of 25 March 1986 laying down minimum standards for the protection of laying hens kept in battery cages);
(2) Article 9 of Directive 88/166/EEC requires the Commission to submit, before 1 January 1993, a report on scientific developments regarding the welfare of hens under various systems of rearing and on the provisions in the Annex to the Directive, accompanied by any appropriate adjustment proposals;
(3) Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes(5), drawn up on the basis of the European Convention for the Protection of Animals kept for Farming Purposes, lays down Community provisions designed to give effect to the principles laid down in the Convention, which include the provision of housing, food, water and care appropriate to the physiological and ethological needs of the animals;
(4) In 1995 the Standing Committee of the European Convention for the Protection of Animals kept for Farming Purposes adopted a detailed recommendation, which includes laying hens;
(5) The protection of laying hens is a matter of Community competence;
(6) Differences which may distort conditions of competition interfere with the smooth running of the organisation of the market in animals and animal products;
(7) The Commission report referred to in recital 2, based on an opinion from the Scientific Veterinary Committee, concludes that the welfare conditions of hens kept in current battery cages and in other systems of rearing are inadequate and that certain of their needs cannot be met in such cages; the highest possible standards should therefore be introduced, in the light of various parameters to be considered in order to improve those conditions;
(8) However, for a period to be determined, the use of unenriched cage systems may be continued under certain conditions, including improved structural and space requirements;
(9) A balance must be kept between the various aspects to be taken into consideration, as regards both welfare and health, economic and social considerations, and also environmental impact;
(10) It is appropriate, while studies on the welfare of laying hens in various systems of rearing are carried out, to adopt provisions that allow the Member States to choose the most appropriate system or systems;
(11) The Commission must submit a new report together with appropriate proposals that take account of that report;
(12) Directive 88/166/EEC should therefore be repealed and replaced,
Article l
1. This Directive lays down minimum standards for the protection of laying hens.
2. This Directive shall not apply to:
- establishments with fewer than 350 laying hens,
- establishments rearing breeding laying hens.
Such establishments shall, however, continue to be subject to the relevant requirements of Directive 98/58/EC.
Article 2
1. The definitions in Article 2 of Directive 98/58/EC shall apply where necessary.
2. In addition, the following definitions shall apply for the purpose of this Directive:
(a) "laying hens" means: hens of the species Gallus gallus which have reached laying maturity and are kept for production of eggs not intended for hatching;
(b) "nest" means: a separate space for egg laying, the floor components of which may not include wire mesh that can come into contact with the birds, for an individual hen or for a group of hens (group nest);
(c) "litter" means: any friable material enabling the hens to satisfy their ethological needs;
(d) "usable area" means: an area at least 30 cm wide with a floor slope not exceeding 14 %, with headroom of at least 45 cm. Nesting areas shall not be regarded as usable areas.
Article 3
According to the system or systems adopted by the Member States, they shall ensure that the owners and holders of laying hens apply not only the relevant provisions of Directive 98/58/EC and of the Annex to this Directive but also the requirements specific to each of the systems referred to below, namely:
(a) either the provisions laid down in Chapter I as regards alternative systems;
(b) or the provisions laid down in Chapter II as regards unenriched cage systems;
(c) or the provisions of Chapter III concerning enriched cages.
CHAPTER I
Provisions applicable to alternative systems
Article 4
1. Member States shall ensure that from 1 January 2002 all newly built or rebuilt systems of production referred to in this chapter and all such systems of production brought into use for the first time comply at least with the requirements below.
1. All systems must be equipped in such a way that all laying hens have:
(a) either linear feeders providing at least 10 cm per bird or circular feeders providing at least 4 cm per bird;
(b) either continuous drinking troughs providing 2,5 cm per hen or circular drinking troughs providing 1 cm per hen.
In addition, where nipple drinkers or cups are used, there shall be at least one nipple drinker or cup for every 10 hens. Where drinking points are plumbed in, at least two cups or two nipple drinkers shall be within reach of each hen;
(c) at least one nest for every seven hens. If group nests are used, there must be at least 1 m2 of nest space for a maximum of 120 hens;
(d) adequate perches, without sharp edges and providing at least 15 cm per hen. Perches must not be mounted above the litter and the horizontal distance between perches must be at least 30 cm and the horizontal distance between the perch and the wall must be at least 20 cm;
(e) at least 250 cm2 of littered area per hen, the litter occupying at least one third of the ground surface.
2. The floors of installations must be constructed so as to support adequately each of the forward-facing claws of each foot.
3. In addition to the provisions laid down in points 1 and 2,
(a) if systems of rearing are used where the laying hens can move freely between different levels,
(i) there shall be no more than four levels;
(ii) the headroom between the levels must be at least 45 cm;
(iii) the drinking and feeding facilities must be distributed in such a way as to provide equal access for all hens;
(iv) the levels must be so arranged as to prevent droppings falling on the levels below.
(b) If laying hens have access to open runs:
(i) there must be several popholes giving direct access to the outer area, at least 35 cm high and 40 cm wide and extending along the entire length of the building; in any case, a total opening of 2 m must be available per group of 1000 hens;
(ii) open runs must be:
- of an area appropriate to the stocking density and to the nature of the ground, in order to prevent any contamination;
- equipped with shelter from inclement weather and predators and, if necessary, appropriate drinking troughs.
4. The stocking density must not exceed nine laying hens per m2 usable area.
However, where the usable area corresponds to the available ground surface, Member States may, until 31 December 2011, authorise a stocking density of 12 hens per m2 of available area for those establishments applying this system on 3 August 1999.
2. Member States shall ensure that the minimum requirements laid down in paragraph 1 apply to all alternative systems from 1 January 2007.
CHAPTER II
Provisions applicable to rearing in unenriched cage systems
Article 5
1. Member States shall ensure that from 1 January 2003 all cage systems referred to in this chapter comply at least with the following requirements:
1. at least 550 cm2 per hen of cage area, measured in a horizontal plane, which may be used without restriction, in particular not including non-waste deflection plates liable to restrict the area available, must be provided for each laying hen;
2. a feed trough which may be used without restriction must be provided. Its length must be at least 10 cm multiplied by the number of hens in the cage;
3. unless nipple drinkers or drinking cups are provided, each cage must have a continuous drinking channel of the same length as the feed trough mentioned in point 2. Where drinking points are plumbed in, at least two nipple drinkers or two cups must be within reach of each cage;
4. cages must be at least 40 cm high over at least 65 % of the cage area and not less than 35 cm at any point;
5. floors of cages must be constructed so as to support adequately each of the forward-facing claws of each foot. Floor slope must not exceed 14 % or 8 %. In the case of floors using other than rectangular wire mesh, Member States may permit steeper slopes;
6. cages shall be fitted with suitable claw-shortening devices.
2. Member States shall ensure that rearing in the cages referred to in this chapter is prohibited with effect from 1 January 2012. In addition, with effect from 1 January 2003 no cages such as referred to in this chapter may be built or brought into service for the first time.
CHAPTER III
Provisions applicable to rearing in enriched cages
Article 6
Member States shall ensure that after 1 January 2002 all the cages referred to in this chapter comply at least with the following requirements:
1. laying hens must have:
(a) at least 750 cm2 of cage area per hen, 600 cm2 of which shall be usable; the height of the cage other than that above the usable area shall be at least 20 cm at every point and no cage shall have a total area that is less than 2000 cm2;
(b) a nest;
(c) litter such that pecking and scratching are possible;
(d) appropriate perches allowing at least 15 cm per hen;
2. a feed trough which may be used without restriction must be provided. Its length must be at least 12 cm multiplied by the number of hens in the cage;
3. each cage must have a drinking system appropriate to the size of the group; where nipple drinkers are provided, at least two nipple drinkers or two cups must be within the reach of each hen;
4. to facilitate inspection, installation and depopulation of hens there must be a minimum aisle width of 90 cm between tiers of cages and a space of at least 35 cm must be allowed between the floor of the building and the bottom tier of cages;
5. cages must be fitted with suitable claw-shortening devices.
CHAPTER IV
Final provisions
Article 7
Member States shall ensure that the establishments covered by the scope of this Directive are registered by the competent authority and given a distinguishing number which will be the medium for tracing eggs placed on the market for human consumption.
The arrangements for implementing this Article shall be determined before 1 January 2002 in accordance with the procedure laid down in Article 11.
Article 8
1. Member States shall take the necessary measures to ensure that the competent authority carries out inspections to monitor compliance with the provisions of this Directive. These inspections may be carried out on the occasion of checks made for other purposes.
2. From a date to be determined in accordance with the procedure provided for in Article 11, Member States shall report to the Commission on the inspections carried out in accordance with paragraph 1. The Commission shall submit summaries of these reports to the Standing Veterinary Committee.
3. Before 1 January 2002 the Commission shall, in accordance with the procedure laid down in Article 11, submit proposals for harmonisation of the following:
(a) the inspections referred to in paragraph 1;
(b) the form and content of the reports referred to in paragraph 2 and the frequency with which they are to be submitted.
Article 9
1. Whenever uniform application of the requirements of this Directive renders it necessary, veterinary experts from the Commission may, in conjunction with the competent authorities:
(a) verify that the Member States are complying with the said requirements;
(b) make on-the-spot checks to ensure that the inspections are carried out in accordance with this Directive.
2. A Member State in whose territory an inspection is made shall provide the veterinary experts from the Commission with any assistance they may require for the performance of their tasks. The outcome of the checks made must be discussed with the competent authority of the Member State concerned before a final report is drawn up and circulated.
3. The competent authority of the Member State concerned shall take any measures which may prove necessary to take account of the results of the checks.
4. Detailed rules for the application of this Article shall be adopted, if necessary, in accordance with the procedure laid down in Article 11.
Article 10
Not later than 1 January 2005 the Commission shall submit to the Council a report, drawn up on the basis of an opinion from the Scientific Veterinary Committee, on the various systems of rearing laying hens, and in particular on those covered by this Directive, taking account both of pathological, zootechnical, physiological, and ethological aspects of the various systems and of their health and environmental impact.
That report shall also be drawn up on the basis of a study of the socio-economic implications of the various systems and their effects on the Community's economic partners.
In addition, it shall be accompanied by appropriate proposals taking into account the conclusions of the report and the outcome of the World Trade Organisation negotiations.
The Council shall act by a qualified majority on these proposals within 12 months of their submission.
Article 11
1. Where the procedure laid down in this Article is to be followed, the matter shall be referred without delay to the Standing Veterinary Committee set up by Decision 68/361/EEC(6), hereinafter referred to as "the committee", by its chairman acting either on his own initiative or at the request of a Member State.
2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 205(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.
(b) If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal relating to the measures to be taken. The Council shall act by qualified majority.
If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the Commission shall adopt the proposed measures and implement them immediately, save where the Council has decided against the said measures by a simple majority.
Article 12
Directive 88/166/EEC is hereby repealed with effect from 1 January 2003.
Article 13
1. Member States shall bring into force the laws, regulations and administrative provisions, including any penalties, necessary to comply with this Directive not later than 1 January 2002. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
2. The Member States may, while respecting the general rules laid down in the Treaty, maintain or apply within their territories provisions for the protection of laying hens which are more stringent than those envisaged by this Directive. They shall inform the Commission of any measure taken to that end.
3. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 14
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 15
This Directive is addressed to the Member States.
|
[
"UKSI20021646"
] |
31999L0077
|
1999
|
Commission Directive 1999/77/EC of 26 July 1999 adapting to technical progress for the sixth time Annex I to Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (asbestos) (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations(1), as last amended by Directive 1999/43/EC of the European Parliament and of the Council(2), and in particular Article 2a thereof, introduced by Council Directive 89/678/EEC(3);
(1) Whereas the use of asbestos and products containing it can, by the release of fibres, cause asbestosis, mesothelioma and lung cancer; whereas placing on the market and use should therefore be subject to the severest possible restrictions;
(2) Whereas Council Directive 83/478/EEC(4) amending for the fifth time Directive 79/769/EEC specified that the crocidolite type of asbestos fibre and products containing it may, with three possible exceptions, no longer be placed on the market and used; whereas this same Directive established obligatory labelling provisions for all products containing asbestos fibres;
(3) Whereas Council Directive 85/610/EEC(5) amending for the seventh time Directive 76/769/EEC specified that asbestos fibres can no longer be placed on the market and used in toys, materials and preparations applied by spraying, retail products in powder form, smoking accessories, catalytic heaters, paints and varnishes;
(4) Whereas Commission Directive 91/659/EEC(6) adapting to technical progress Annex I of Directive 76/769/EEC specified that all of the amphibole type of asbestos fibres and products containing them may no longer be placed on the market and used; whereas this same directive specified that the chrysotile type of asbestos fibre and products containing it may no longer be placed on the market and used for fourteen categories of products;
(5) Whereas the Scientific Committee on Toxicity, Ecotoxicity and the Environment was consulted on the health effects of chrysotile asbestos and its substitutes;
(6) Whereas there are now available for most remaining uses of chrysotile asbestos substitutes or alternatives which are not classified as carcinogens and are regarded as less dangerous;
(7) Whereas no threshold level of exposure has yet been identified below which chrysotile asbestos does not pose carcinogenic risks;
(8) Whereas exposure of workers and other users of asbestos-containing products is extremely difficult to control and may greatly exceed current limit values on an intermittent basis and this category of exposure now poses the greatest risks for development of asbestos-related diseases;
(9) Whereas an effective way of protecting human health is to prohibit the use of chrysotile asbestos fibres and products containing them;
(10) Whereas the scientific knowledge about asbestos and its substitutes is continually developing; whereas the Commission will therefore ask the Scientific Committee on Toxicity, Ecotoxicity and the Environment to undertake a further review of any relevant new scientific data on the health risks of chrysotile asbestos and its substitutes before 1 January 2003; whereas this review will also consider other aspects of this directive, in particular the derogations, in the light of technical progress; whereas, if necessary, the Commission will propose appropriate changes to legislation;
(11) Whereas a period of adjustment is required to phase out the marketing and use of chrysotile asbestos and products containing it; whereas this period should be longer for diaphragms used for electrolysis in existing installations because the risk of exposure is extremely low and more time is necessary to develop suitable alternatives in this safety-critical application; whereas the Commission will review this derogation before 1 January 2008 after having consulted the Scientific Committee on Toxicity, Ecotoxicity and the Environment;
(12) Whereas this Directive is without prejudice to Council Directive 89/391/EEC laying down minimum requirements for the protection of workers(7), and its individual Directives within the meaning of Article 16(1) of that Directive, in particular Council Directive 90/394/EEC of 28 June 1990 on protection of workers from the risks related to exposure to carcinogens at work(8) as amended by Directive 97/42/EC(9);
(13) Whereas Council Directive 91/382/EEC(10) amending Directive 83/477/EEC on the protection of workers from the risks related to exposure to asbestos at work provides a framework of control where activities may expose workers to asbestos dust;
(14) Whereas this Directive is whithout prejudice to Commission Directive 98/12/EC(11) adapting to technical progress Council Directive 71/320/EEC on the approximation of the laws of the Member States relating to the braking devices of certain categories of motor vehicles and their trailers;
(15) Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress of the Directives on the removal of technical barriers to trade in dangerous substances and preparations,
Article 1
Annex I to Directive 76/769/EEC is hereby adapted to technical progress as set out in the Annex hereto.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1st January 2005 at the latest and shall immediately inform the Commission thereof.
When Member States adopt these provisions, these shall contain a reference to the Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
2. Member States shall communicate to the Commission the main provisions of national law which they adopt in the field covered by this Directive.
3. From entry into force of this Directive to 1st January 2005, Member States may not allow the introduction of new applications for chrysotile asbestos on their territories.
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI19992373"
] |
31999L0072
|
1999
|
Directive 1999/72/EC of the European Parliament and OF THE Council of 29 July 1999 amending Directive 92/117/EEC of the Council concerning measures for protection against specified zoonoses and specific zoonotic agents in animals and products of animal origin in order to prevent outbreaks of food-borne infections and intoxications
Having regard to the Treaty establishing the European Community, and in particular Article 152(4) thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),
Whereas:
(1) in the light of the experience acquired and the importance accorded to the prevention and control of zoonoses it appears necessary to carry out a substantial review of the provisions of Council Directive 92/117/EEC of 17 December 1992 concerning measures for protection against specified zoonoses and specific zoonotic agents in animals and products of animal origin in order to prevent outbreaks of food-borne infections and intoxications(4);
(2) such substantial review could consist of introducing new provisions for the reporting system for zoonoses, improved rules for the control and eradication of salmonellosis in poultry flocks, and a system to control other zoonoses than salmonellosis;
(3) such a substantial review requires consultation of and consideration by all the parties concerned, including in particular consumer organisations, the farming industry and the scientific world;
(4) pending this review it is appropriate to provide both for a postponement of the deadlines for plans to be submitted by third countries and for a postponement of the obligation on the Commission to submit to the European Parliament and the Council proposals on new provisions,
Article 1
Directive 92/117/EEC is amended as follows:
1. in Article 14(2), the words "31 December 1998" shall be replaced by "one year after the entry into force of the acts pursuant to the proposals referred to in Article 15a(2)".
2. Article 15a shall be amended as follows:
(a) in paragraph 1, second line, the date "1 November 1997" shall be replaced by "31 March 2000";
(b) in paragraph 2, at the end, the date "1 June 1998" shall be replaced by "31 December 2000".
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 May 2001. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making reference shall be laid down by Member States.
2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof.
Article 3
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI19931898"
] |
31999L0082
|
1999
|
Commission Directive 1999/82/EC of 8 September 1999 amending the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products(1), as last amended by Directive 93/39/EEC(2), and in particular Article 2(a)(1) thereof,
(1) Whereas Commission Decision 97/534/EC of 30 July 1997 on the prohibition of the use of material presenting risks as regards transmissible spongiform encephalopathies(3) defines specified risk materials, provides for their elimination at source and prohibits their import into the Community;
(2) Whereas, prior to being marketed, all medicinal products, whether they originate in the Community or are imported from third countries, are subject to an approval procedure in the context of which the treatment process of any raw material is evaluated, in conformity with the provisions of the Annex to Directive 75/318/EEC;
(3) Whereas this approval procedure applies to all medicinal products to be placed on the market in the Community, notwithstanding the origin of the product or the raw materials contained therein; whereas, thereby, the compliance with Community law of medicinal products, starting materials and intermediate products which are imported into the Community to be used in the manufacture of medicinal products is systematically controlled and checked;
(4) Whereas on 21 April 1999, the Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products adopted an updated Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products;
(5) Whereas, in drafting this updated Note for Guidance, the Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products took into account all relevant Opinions of the Scientific Committee on Medicinal Products and Medical Devices, as well as the Scientific Steering Committee and additional scientific considerations which apply to the specific field of medicinal products;
(6) Whereas, the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products will have to be regularly updated and modified by the Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products, taking into account the latest scientific developments;
(7) Whereas the Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products and its updates are published by the European Commission in Volume 3 of its publication "The rules governing medicinal products in the European Union";
(8) Whereas this Note for Guidance is considered to be adequate to assure that the risk of transmitting Animal Spongiform Encephalopathy via medicinal products is minimised since manufacturers of medicinal products are obliged under Directive 75/318/EEC to take into account the relevant Community guidelines in assembling the dossier for application for marketing authorisation;
(9) Whereas it contributes to the clarity of the legal situation and ensures the highest reasonable level of protection of public health to amend the Annex to Directive 75/318/EEC to expressly make compliance with the above Note for Guidance binding with regard to all marketing authorisations for medicinal products and to provide for an appropriate phasing-in period for already existing marketing authorisations;
(10) Whereas the measures provided for in this Directive are in conformity with the opinion of the Standing Committee for Medicinal Products for Human Use,
Article 1
The Annex to Directive 75/318/EEC is hereby amended as shown in the Annex.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 1 January 2000.
2. Member States shall take the necessary measures to ensure that:
- applications for marketing authorisations for medicinal products lodged as from 1 July 2000 comply with the criteria set out in the Annex to this Directive,
- all marketing authorisations for medicinal products meet the criteria of the Annex to this Directive not later than 1 March 2001.
3. When the Member States adopt the provisions set out in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such references shall be adopted by the Member States.
4. The Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20000292"
] |
31999L0083
|
1999
|
Commission Directive 1999/83/EC of 8 September 1999 amending the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products(1), as last amended by Directive 93/39/EEC(2), and in particular Article 2(a)(1) thereof;
(1) Whereas it is possible to replace results of pharmacological and toxicological tests or clinical trials by detailed references to published scientific literature if it can be demonstrated that the constituent(s) of a medicinal product have a well-established medicinal use, with recognised efficacy and an acceptable level of safety in accordance with point 8(a) and (b) of Article 4(2), of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(3);
(2) Whereas Article 1(2) of Directive 75/318/EEC provides that where pursuant to point 8(a) and (b) of Article 4(2), of Directive 65/65/EEC references to published data are submitted (bibliographical applications), the provisions of Directive 75/318/EEC shall apply "in like manner";
(3) Whereas the increased speed of innovation and publication of innovation as well as the increasingly stringent requirements foreseen by Community pharmaceutical legislation for new medicinal products make it necessary to define the conditions applicable to bibliographic applications more closely and to determine more exactly the meaning of "in like manner" in Article 1(2) of Directive 75/318/EEC;
(4) Whereas it must be ensured that the possibility of submitting "bibliographical applications" does not discourage innovative companies to publish results of their research as quickly as possible;
(5) Whereas it is therefore necessary to lay down a more detailed common understanding of the conditions for "bibliographical applications" and in particular the meaning of "well established use" pursuant to point 8(a) and (b) of Article 4(2), of Directive 65/65/EEC;
(6) Whereas it is in particular necessary to clarify that "bibliographic reference" to other sources of evidence (postmarketing studies, epidemiological studies, studies conducted with similar products, etc.) and not just tests and trials may serve as a valid proof of safety and efficacy of a product if an applicant explains and justifies the use of these sources of information satisfactorily;
(7) Whereas the rules laid down in this Directive are to a large extent in line with current administrative practice in the majority of Member States;
(8) Whereas this amendment may help in solving practical problems Member States are facing concerning the authorisation of old medicinal products;
(9) Whereas the measures provided for in this Directive are in conformity with the opinion of the Standing Committee for Medicinal Products for Human Use,
Article 1
The Annex to Directive 75/318/EEC is hereby amended as shown in the Annex.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 1 March 2000.
2. When the Member States adopt the provisions set out in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States.
3. The Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20000292"
] |
31999L0084
|
1999
|
Commission Directive 1999/84/EC of 20 October 1999 amending Directive 92/76/EEC recognising protected zones exposed to particular plant health risks in the Community
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(1), as amended by Commission Directive 1999/53/EC(2) and in particular the first subparagraph of Article 2(1)(h) thereof,
Having regard to Commission Directive 92/76/EEC of 6 October 1992 recognising protected zones exposed to particular plant health risks in the Community(3), as last amended by Directive 98/100/EC(4),
(1) Whereas under Directive 92/76/EEC, as amended, the United Kingdom was provisionally recognised as a "protected zone" in respect of beet necrotic yellow vein virus for a period expiring on 1 November 1999;
(2) Whereas, from information supplied by the United Kingdom and from the information gathered by the Food and Veterinary Office during a mission carried out in 1999 it appears that the provisional recognition of the protected zone for the United Kingdom in respect of beet necrotic yellow vein virus should be extended for a further limited period to enable the responsible official bodies of the United Kingdom to complete the information on the distribution of beet necrotic yellow vein virus and to complete their efforts for the eradication of this harmful organism in the East Anglian area of the United Kingdom;
(3) Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,
Article 1
The date of "1 November 1999" referred to in the first subparagraph of Article 1 of Directive 92/76/EEC is hereby replaced by "1 November 2001".
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 1 November 1999. They shall immediately inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The procedure for such a reference shall be adopted by Member States.
2. Member States shall immediately communicate to the Commission the essential provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof.
Article 3
This Directive shall enter into force on the day following its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI19931320"
] |
31999L0086
|
1999
|
Council Directive 1999/86/EC of 11 November 1999 adapting to technical progress Directive 76/763/EEC on the approximation of the laws of the Member States relating to passenger seats for wheeled agricultural or forestry tractors
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors(1), and in particular Article 11 thereof,
Having regard to Council Directive 76/763/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to passenger seats for wheeled agricultural or forestry tractors(2), and in particular Article 4 thereof,
Having regard to the proposal from the Commission,
Whereas:
(1) The objective of this Directive is to improve the current design of passenger seats; in response to the comments made by certain Member States, further provisions on passenger seats need to be introduced at a later stage, with a view to increasing passenger safety;
(2) In order to increase safety, any obstruction hampering the driver should be avoided;
(3) The Committee for Adaptation to Technical Progress established by Directive 74/150/EEC failed to deliver an opinion within the time allowed by its Chairman,
Article 1
The Annex to Directive 76/763/EEC is hereby amended as shown in the Annex hereto.
Article 2
1. From 1 January 2001, no Member State may:
- refuse, in respect of any type of tractor, to grant EC type-approval, to issue the document referred to in the third indent of Article 10(1) of Directive 74/150/EEC, or to grant national type-approval, or
- prohibit the entry into service of tractors;
if those tractors meet the requirements of Directive 76/763/EEC, as amended by this Directive.
2. From 1 October 2001, Member States:
- shall no longer issue the document provided for in the third indent of Article 10(1) of Directive 74/150/EEC for any type of tractor,
- may refuse to grant national type-approval in respect of any type of tractor;
that does not meet the requirements of Directive 76/763/EEC, as amended by this Directive.
Article 3
Before 1 October 2002, and in accordance with the procedure laid down in Article 13(3) of Directive 74/150/EEC, the Commission shall further amend Directive 76/763/EEC in order to introduce additional provisions on passenger seats with a view to further increasing passenger safety.
Article 4
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 January 2001. They shall forthwith inform the Commission thereof.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of domestic law that they adopt in the field governed by this Directive.
Article 5
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 6
This Directive is addressed to the Member States.
|
[
"UKSI20000828"
] |
31999L0090
|
1999
|
Council Directive 1999/90/EC of 15 November 1999 amending Directive 90/539/EEC on animal health conditions governing intra-Community trade in and imports from third countries of poultry and hatching eggs
Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the European Parliament(2),
Having regard to the opinion of the Economic and Social Committee(3),
Whereas:
(1) Article 12(1) of Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in and imports from third countries of poulty and hatching eggs(4) lays down the rules which apply to poultry and hatching eggs destined for Member States or regions of Member States, the status of which has been recognised in accordance with Article 12(2) of the said Directive;
(2) Commission Decision 93/152/EEC of 8 February 1993 laying down the criteria for vaccines to be used against Newcastle disease in the context of routine vaccinations programmes(5) applies from 1 January 1995;
(3) It is appropriate, as a result, to modify Council Directive 90/539/EEC, in particular Article 12 thereof;
(4) Article 11 of the Directive provides, for practical reasons, for a special regime for the intracommunity trade in very small consignments of poultry; whereas trade in ratites should, however, be included in the general provisions of the Directive;
(5) It is appropriate to amend the trading rules as applied to third countries by introducing the possibility of drawing up supplementary rules for imports of poultry and hatching eggs, which offer animal health guarantees at least equivalent to those laid down in Chapter II of Directive 90/539/EEC and furthermore contain provisions for the establishing of quarantine measures;
(6) It is appropriate, moreover, in the light of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(6) to modify Directive 90/539/EEC,
Article 1
Directive 90/539/EEC is hereby amended as follows:
1. In Article 11, the following paragraph shall be added as follows: "3. The provisions of paragraphs 1 and 2 shall not apply to consignments containing ratites or hatching eggs of ratites.";
2. Article 12(1) shall be replaced by the following: "1. In the case of consignments of poultry and hatching eggs from Member States or regions of Member States which vaccinate the poultry referred to in Article 1 against Newcastle disease to a Member state or region of a Member State, the status of which has been established in accordance with paragraph 2 below, the following rules shall apply:
(a) hatching eggs must come from flocks which are:
- not vaccinated, or
- vaccinated using inactivated vaccine, or
- vaccinated using a live vaccine, provided that vaccination has taken place at least 30 days before the collection of the hatching eggs;
(b) day-old chicks (including chicks intended for restocking supplies of game) must not be vaccinated against Newcastle disease, and must come from:
- hatching eggs satisfying the conditions in (a), and
- a hatchery where working practice ensures that such eggs are incubated at completely separate times and locations from eggs not satisfying the conditions in (a);
(c) breeding and productive poultry must:
- not be vaccinated against Newcastle disease, and
- have been isolated for 14 days before consignment, at either a holding or a quarantine station under the supervision of the official veterinarian. In this connection, no poultry at the holding of origin or quarantine station, as applicable, may have been vaccinated against Newcastle disease during the 21 days preceding consignment and no bird which is not due for consignment may have entered the holding or the quarantine station during that time; in addition, no vaccination may be carried out in the quarantine stations, and
- have undergone, during the 14 days preceding consignment, representative serological testing, with negative results, to detect Newcastle disease antibodies in accordance with detailed rules adopted pursuant to the procedure laid down in Article 32;
(d) slaughter poultry must come from flocks which:
- if not vaccinated against Newcastle disease, satisfy the requirements in the third indent of (c),
- if vaccinated have undergone, during the 14 days preceding consignment and on the basis of a representative sample, a test to isolate Newcastle disease virus complying with detailed rules adopted in accordance with the procedure laid down in Article 32.";
3. Article 12(4) shall be deleted;
4. Article 26(2) shall be replaced by the following: "2. The Commission may, in accordance with the procedure laid down in Article 32, determine that the imported poultry, hatching eggs or poultry hatched from imported eggs is to be kept quarantined or isolated for a period which may not exceed two months."
5. The following Article shall be added: "Article 27a
Notwithstanding Articles 20, 22, 23 and 24, the Commission may, in accordance with the procedure laid down in Article 32, decide to permit on a case-by-case basis the importation of poultry and hatching eggs from third countries where such imports do not conform to the provisions of Articles 20, 22, 23 and 24. Detailed rules for such importation shall be drawn up concomitantly with the same procedure. Such rules shall offer animal health guarantees at least equivalent to the animal health guarantees offered by Chapter II of this Directive, involving compulsory quarantine and testing for Avian Influenza, Newcastle disease and any other relevant disease.";
6. Article 32 shall be replaced by the following: "Article 32
1. The Commission shall be assisted by the Standing Veterinary Committee established by Decision 68/361/EEC(7), composed of representatives of the Member States and chaired by the representative of the Commission.
2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 205(2) of the Treaty in the case of decisions for which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
4. If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken.
5. The Council, acting by qualified majority, shall act on the proposal within three months of the date of referral.
If, within that period, the Council indicates by qualified majority that it opposes the proposal, the Commission shall reconsider it. It may present an amended proposal to the Council, re-submit the same proposal or present a legislative proposal on the basis of the Treaty.
If the Council has not adopted the proposed implementing measures or has not indicated its opposition to the proposed implementing measures by the expiry of the time limit, they shall be adopted by the Commission.";
7. Article 33 shall be replaced by the following: "Article 33
1. The Commission shall be assisted by the Standing Veterinary Committee established by Decision 68/361/EEC, composed of representatives of the Member States and chaired by the representantives of the Commission.
2. The representantive of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 205(2) of the Treaty in the case of decisions for which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.
4. If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken.
5. The Council, acting by qualified majority, shall act on the proposal within 15 days of the date of referral.
If, within that period, the Council indicates by qualified majority that it opposes the proposal, the Commission shall reconsider it. It may present an amended proposal to the Council, resubmit the same proposal or present a legislative proposal on the basis of the Treaty.
If the Council has not adopted the proposed implementing measures or has not indicated its opposition to the proposed implementing measures by the expiry of the time limit, they shall be adopted by the Commisision."
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 2000. They shall forthwith inform the Commission thereof.
When Member States adopt these measures they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.
Article 3
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20001673"
] |
31999L0091
|
1999
|
Commission Directive 1999/91/EC of 23 November 1999 amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs(1) and in particular Article 3 thereof,
After consulting the Scientific Committee on Food,
Whereas:
(1) Commission Directive 90/128/EEC(2), as last amended by Directive 96/11/EC(3), provides in Article 3(2) for the revision of Annex II thereto.
(2) On the basis of the information available, certain monomers provisionally admitted at national level may be included in the Community list.
(3) Other monomers have been requested for use following the adoption of Directive 90/128/EEC: the technical data supplied permit their inclusion in the Community list.
(4) Annex III to Directive 90/128/EEC includes a list of additives, which should be amended so as to include other additives fully evaluated by the Scientific Committee on Food.
(5) For certain substances, the restrictions already set out should be amended according to the information available.
(6) The current total list of additives is an incomplete list inasmuch as it does not contain all the substances which are currently accepted in one or more Member States; accordingly, these substances continue to be regulated by national laws pending a decision on inclusion in the Community list.
(7) This Directive establishes purity criteria for only a few substances, and therefore the other substances which may require purity criteria remain regulated in this respect by national laws pending a decision at Community level.
(8) The measures contained in this Directive do not go beyond what is necessary to achieve the objectives already provided for in Directive 89/109/EEC.
(9) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,
Article 1
Directive 90/128/EEC is amended as follows:
1. the fourth indent of Article 3(5) is deleted;
2. Article 3a is replaced by the following: "Article 3a
An incomplete list of additives which may be used for the manufacture of plastic materials and articles, together with the restrictions on their use, is set out in Annex III";
3. the following Articles 3b and 3c are inserted: "Article 3b
Only the products obtained by means of bacterial fermentation listed in Annex IV may be used in contact with foodstuffs.
Article 3c
1. The specifications relating to some substances appearing in Annexes II, III and IV are laid down in Annex V.
2. The meaning of the numbers between brackets appearing in the Column 'Restrictions and/or specifications' is explained in Annex VI";
4. Annex II is amended as shown in Annex I to this Directive;
5. Annex III is amended as shown in Annex II to this Directive;
6. the texts set out in Annex III to this Directive are added as Annexes IV, V and VI.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 2000. They shall immediately inform the Commission thereof.
Member States shall permit, as from 1 January 2002, the trade in and use of plastic materials and articles intended to come into contact with foodstuffs and complying with this Directive.
They shall prohibit, as from 1 January 2003, the manufacture and importation into the Community of plastic materials and articles intended to come into contact with foodstuffs and which do not comply with this Directive.
2. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 3
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20003162"
] |
31999L0095
|
1999
|
Directive 1999/95/EC of the European Parliament and of the Council of 13 December 1999 concerning the enforcement of provisions in respect of seafarers' hours of work on board ships calling at Community ports
Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),
Whereas:
(1) Community action in the field of social policy aims, inter alia, at improving the health and safety of workers in their working environment;
(2) Community action in the field of maritime transport aims, inter alia, at improving shipboard living and working conditions of seafarers, safety at sea and the prevention of pollution caused by maritime accidents;
(3) During its eighty-fourth session of 8 to 22 October 1996 the International Labour Organisation Conference (ILO) adopted ILO Convention No 180 concerning Seafarers' Hours of Work and the Manning of Ships, 1996 (hereinafter "ILO Convention No 180" and the Protocol to the Merchant Shipping (Minimum Standards) Convention, 1976 (hereinafter "the Protocol to ILO Convention No 147");
(4) Council Directive 99/63/EC of 21 June 1999 concerning the Agreement on the organisation of working time of seafarers concluded by the European Community Shipowners' Association (ECSA) and the Federation of Transport Workers' Unions in the European Union (FST)(4) adopted under Article 139(2) of the Treaty, aims to put into effect the said Agreement concluded on 30 September 1998 (hereinafter the "Agreement"); the content of the Agreement reflects certain provisions of ILO Convention No 180; the Agreement applies to seafarers on board every seagoing ship, whether publicly or privately owned, which is registered in the territory of any Member State and is ordinarily engaged in commercial maritime operations;
(5) The purpose of this Directive is to apply the provisions of Directive 1999/63/EC which reflect the provisions of ILO Convention No 180, to any ship calling at a Community port, irrespective of the flag it flies in order to identify and remedy any situation which is manifestly hazardous for the safety or health of seafarers; however, Directive 1999/63/EC includes requirements which are not to be found in ILO Convention No 180 and which should not therefore be enforced on board ships not flying the flag of a Member State;
(6) Directive 1999/63/EC applies to seafarers on board every seagoing ship registered in the territory of a Member State; Member States should monitor compliance with all the provisions of the said Directive by ships registered in their territory;
(7) In order to protect safety and to avoid distortions of competition, Member States should be allowed to verify compliance with the relevant provisions of Directive 1999/63/EC by all sea-going vessels calling at their ports, irrespective of the State in which they are registered;
(8) In particular, ships flying the flag of a State which is not a party to ILO Convention No 180 or the Protocol to ILO Convention No 147 should not receive more favourable treatment than those flying the flag of a State which is a party to either the Convention or Protocol or to both of them;
(9) For the control of the effective enforcement of Directive 1999/63/EC, it is necessary that Member States carry out inspections on board ships, notably after having received a complaint by the master, a crew member, or any person or organisation with a legitimate interest in the safe operation of the ship, shipboard living and working conditions or the prevention of pollution;
(10) For the purposes of this Directive Member States, on their own initiative, may designate, as appropriate, Port State Control inspectors to carry out inspections on board vessels calling at Community ports;
(11) Evidence that a ship does not comply with the requirements of Directive 1999/63/EC may be obtained after verification of the shipboard working arrangements and seafarers' records of hours of work or hours of rest, or when the inspector has a reasonable belief that seafarers are excessively fatigued;
(12) In order to rectify any conditions on board a ship which are clearly hazardous to safety or health, the competent authority of the Member State in whose port the ship has called may impose a prohibition on leaving the port until the deficiencies found have been rectified or the crew is sufficiently rested;
(13) Since Directive 1999/63/EC reflects the provisions of ILO Convention No 180, verification of compliance with the provisions of that Directive by ships registered in the territory of a third State can take place only when this Convention has entered into force,
Article 1
Purpose and scope
1. The purpose of this Directive is to provide a mechanism for the verification and enforcement of compliance by ships calling at ports of Member States with Directive 1999/63/EC in order to improve maritime safety, working conditions and the health and safety of seafarers on board ships.
2. Member States shall take appropriate measures to ensure that ships which are not registered in their territory or not flying their flag comply with clauses 1 to 12 of the Agreement annexed to Directive 1999/63/EC.
Article 2
Definitions
For the purposes of this Directive,
(a) "ship" means any seagoing vessel, whether publicly or privately owned, which is ordinarily engaged in commercial maritime operations. Fishing vessels are not included in this definition,
(b) "competent authority" means the authorities designated by the Member States to perform functions under this Directive,
(c) "inspector" means a public-sector employee or other person, duly authorised by the competent authority of a Member State to inspect the working conditions on board, and responsible to that competent authority,
(d) "complaint" means any information or report submitted by a member of the crew, a professional body, an association, a trade union or, generally, any person with an interest in the safety of the ship, including an interest in safety or health hazards to its crew.
Article 3
Preparation of reports
Without prejudice to Article 1 (2), if a Member State in whose port a ship calls voluntarily in the normal course of its business or for operational reasons receives a complaint which it does not consider manifestly unfounded or obtains evidence that the ship does not conform to the standards referred to in Directive 1999/63/EC, it shall prepare a report addressed to the government of the country in which the ship is registered and, when an inspection carried out pursuant to Article 4 provides relevant evidence, the Member State shall take the measures necessary to ensure that any conditions on board which are clearly hazardous to the safety or the health of the crew are rectified.
The identity of the person lodging the report or the complaint must not be revealed to the master or the owner of the ship concerned.
Article 4
Inspection and more detailed inspection
1. When carrying out an inspection, in order to obtain evidence that a ship does not conform to the requirements of Directive 1999/63/EC, the inspector shall determine whether:
- a table with the shipboard working arrangements has been established in the working language or languages of the ship and in English according to the model format reproduced in Annex I, or in an alternative equivalent format, and is posted on board in an easily accessible place;
- seafarers' records of hours of work or hours of rest have been established in the working language or languages of the ship and in English according to the model format reproduced in Annex II, or in an alternative equivalent format, and are kept on board and there is proof that the records have been endorsed by the competent authority of the State where the ship is registered.
2. If a complaint has been received or the inspector from his own observations on board believes that the seafarers may be unduly fatigued, the inspector shall conduct a more detailed inspection, pursuant to paragraph 1, to determine whether the working hours or rest periods recorded conform to the standards laid down in Directive 1999/63/EC and that they have been duly observed, taking into account other records relating to the operation of the ship.
Article 5
The rectification of deficiencies
1. If the inspection or the more detailed inspection reveals that the ship does not conform to the requirements of Directive 1999/63/EC, the Member State shall take the measures necessary to ensure that any conditions on board which are clearly hazardous to the safety or health of seafarers are rectified. Such measures may include a prohibition on leaving the port until deficiencies have been rectified or the seafarers have been sufficiently rested.
2. If there is clear evidence that watchkeeping personnel for the first watch or subsequent relieving watches are unduly fatigued, the Member State shall ensure that the ship shall not leave port until the deficiencies found have been rectified or the seafarers in question have been sufficiently rested.
Article 6
Follow-up procedures
1. In the event that a ship is prohibited from leaving the port pursuant to Article 5, the competent authority of the Member State shall inform the master, the owner or operator, the administration of the flag State or the State where the ship is registered or the Consul, or in his absence the nearest diplomatic representative of the State, of the results of the inspections referred to in Article 4, of any decisions taken by the inspector and of corrective actions required, if necessary.
2. When carrying out an inspection under this Directive, all possible efforts should be made to avoid a ship being unduly delayed. If a ship is unduly delayed, the owner or operator shall be entitled to compensation for any loss or damage suffered. In any instance of alleged undue delay, the burden of proof shall lie with the owner or operator of the ship.
Article 7
Right of appeal
1. The owner or the operator of the ship or his representative in the Member State shall have a right of appeal against a detention decision taken by the competent authority. An appeal shall not cause the detention to be suspended.
2. Member States shall establish and maintain appropriate procedures for this purpose in accordance with their national legislation.
3. The competent authority shall properly inform the master of a ship referred to in paragraph 1 of the right of appeal.
Article 8
Administrative cooperation
1. Member States shall take the necessary steps to provide, in conditions compatible with those laid down in Article 14 of Directive 95/21/EC of 19 June 1995 concerning the enforcement, in respect of shipping using Community ports and sailing in the waters under the jurisdiction of the Member States, of international standards for ship safety, pollution prevention and shipboard living and working conditions (port State control)(5), for cooperation between their relevant authorities and the relevant competent authorities of other Member States to ensure the effective application of this Directive and shall notify the Commission of the provision made.
2. Information on the measures taken pursuant to Articles 4 and 5 shall be published in accordance with procedures such as those set out in the first paragraph of Article 15 of Directive 95/21/EC.
Article 9
"No more favourable" treatment clause
When inspecting a ship registered in the territory of or flying the flag of a State which has not signed ILO Convention No 180 or the Protocol to ILO Convention No 147, Member States shall, once the Convention and the Protocol are in force, ensure that the treatment given to such ships and their crew is no more favourable than that given to a ship flying the flag of a State which is a party to either ILO Convention No 180 or the Protocol to ILO Convention No 147 or both of them.
Article 10
Final provisions
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 June 2002.
2. When Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
3. Member States shall immediately notify to the Commission all provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof.
Article 11
Ships from non-Member States
This Directive shall apply to ships not registered in the territory of, or not flying the flag of, a Member State only on the date of entry into force of ILO Convention No 180 and the date of entry into force of the Protocol to ILO Convention No 147.
Article 12
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 13
Addressees
This Directive is addressed to the Member States.
|
[
"UKSI20022125"
] |
31999L0093
|
1999
|
Directive 1999/93/EC of the European Parliament and of the Council of 13 December 1999 on a Community framework for electronic signatures
Having regard to the Treaty establishing the European Community, and in particular Articles 47(2), 55 and 95 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Having regard to the opinion of the Committee of the Regions(3),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(4),
Whereas:
(1) On 16 April 1997 the Commission presented to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions a Communication on a European Initiative in Electronic Commerce;
(2) On 8 October 1997 the Commission presented to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions a Communication on ensuring security and trust in electronic communication - towards a European framework for digital signatures and encryption;
(3) On 1 December 1997 the Council invited the Commission to submit as soon as possible a proposal for a Directive of the European Parliament and of the Council on digital signatures;
(4) Electronic communication and commerce necessitate " electronic signatures" and related services allowing data authentication; divergent rules with respect to legal recognition of electronic signatures and the accreditation of certification-service providers in the Member States may create a significant barrier to the use of electronic communications and electronic commerce; on the other hand, a clear Community framework regarding the conditions applying to electronic signatures will strengthen confidence in, and general acceptance of, the new technologies; legislation in the Member States should not hinder the free movement of goods and services in the internal market;
(5) The interoperability of electronic-signature products should be promoted; in accordance with Article 14 of the Treaty, the internal market comprises an area without internal frontiers in which the free movement of goods is ensured; essential requirements specific to electronic-signature products must be met in order to ensure free movement within the internal market and to build trust in electronic signatures, without prejudice to Council Regulation (EC) No 3381/94 of 19 December 1994 setting up a Community regime for the control of exports of dual-use goods(5) and Council Decision 94/942/CFSP of 19 December 1994 on the joint action adopted by the Council concerning the control of exports of dual-use goods(6);
(6) This Directive does not harmonise the provision of services with respect to the confidentiality of information where they are covered by national provisions concerned with public policy or public security;
(7) The internal market ensures the free movement of persons, as a result of which citizens and residents of the European Union increasingly need to deal with authorities in Member States other than the one in which they reside; the availability of electronic communication could be of great service in this respect;
(8) Rapid technological development and the global character of the Internet necessitate an approach which is open to various technologies and services capable of authenticating data electronically;
(9) Electronic signatures will be used in a large variety of circumstances and applications, resulting in a wide range of new services and products related to or using electronic signatures; the definition of such products and services should not be limited to the issuance and management of certificates, but should also encompass any other service and product using, or ancillary to, electronic signatures, such as registration services, time-stamping services, directory services, computing services or consultancy services related to electronic signatures;
(10) The internal market enables certification-service-providers to develop their cross-border activities with a view to increasing their competitiveness, and thus to offer consumers and businesses new opportunities to exchange information and trade electronically in a secure way, regardless of frontiers; in order to stimulate the Community-wide provision of certification services over open networks, certification-service-providers should be free to provide their services without prior authorisation; prior authorisation means not only any permission whereby the certification-service-provider concerned has to obtain a decision by national authorities before being allowed to provide its certification services, but also any other measures having the same effect;
(11) Voluntary accreditation schemes aiming at an enhanced level of service-provision may offer certification-service-providers the appropriate framework for developing further their services towards the levels of trust, security and quality demanded by the evolving market; such schemes should encourage the development of best practice among certification-service-providers; certification-service-providers should be left free to adhere to and benefit from such accreditation schemes;
(12) Certification services can be offered either by a public entity or a legal or natural person, when it is established in accordance with the national law; whereas Member States should not prohibit certification-service-providers from operating outside voluntary accreditation schemes; it should be ensured that such accreditation schemes do not reduce competition for certification services;
(13) Member States may decide how they ensure the supervision of compliance with the provisions laid down in this Directive; this Directive does not preclude the establishment of private-sector-based supervision systems; this Directive does not oblige certification-service-providers to apply to be supervised under any applicable accreditation scheme;
(14) It is important to strike a balance between consumer and business needs;
(15) Annex III covers requirements for secure signature-creation devices to ensure the functionality of advanced electronic signatures; it does not cover the entire system environment in which such devices operate; the functioning of the internal market requires the Commission and the Member States to act swiftly to enable the bodies charged with the conformity assessment of secure signature devices with Annex III to be designated; in order to meet market needs conformity assessment must be timely and efficient;
(16) This Directive contributes to the use and legal recognition of electronic signatures within the Community; a regulatory framework is not needed for electronic signatures exclusively used within systems, which are based on voluntary agreements under private law between a specified number of participants; the freedom of parties to agree among themselves the terms and conditions under which they accept electronically signed data should be respected to the extent allowed by national law; the legal effectiveness of electronic signatures used in such systems and their admissibility as evidence in legal proceedings should be recognised;
(17) This Directive does not seek to harmonise national rules concerning contract law, particularly the formation and performance of contracts, or other formalities of a non-contractual nature concerning signatures; for this reason the provisions concerning the legal effect of electronic signatures should be without prejudice to requirements regarding form laid down in national law with regard to the conclusion of contracts or the rules determining where a contract is concluded;
(18) The storage and copying of signature-creation data could cause a threat to the legal validity of electronic signatures;
(19) Electronic signatures will be used in the public sector within national and Community administrations and in communications between such administrations and with citizens and economic operators, for example in the public procurement, taxation, social security, health and justice systems;
(20) Harmonised criteria relating to the legal effects of electronic signatures will preserve a coherent legal framework across the Community; national law lays down different requirements for the legal validity of hand-written signatures; whereas certificates can be used to confirm the identity of a person signing electronically; advanced electronic signatures based on qualified certificates aim at a higher level of security; advanced electronic signatures which are based on a qualified certificate and which are created by a secure-signature-creation device can be regarded as legally equivalent to hand-written signatures only if the requirements for hand-written signatures are fulfilled;
(21) In order to contribute to the general acceptance of electronic authentication methods it has to be ensured that electronic signatures can be used as evidence in legal proceedings in all Member States; the legal recognition of electronic signatures should be based upon objective criteria and not be linked to authorisation of the certification-service-provider involved; national law governs the legal spheres in which electronic documents and electronic signatures may be used; this Directive is without prejudice to the power of a national court to make a ruling regarding conformity with the requirements of this Directive and does not affect national rules regarding the unfettered judicial consideration of evidence;
(22) Certification-service-providers providing certification-services to the public are subject to national rules regarding liability;
(23) The development of international electronic commerce requires cross-border arrangements involving third countries; in order to ensure interoperability at a global level, agreements on multilateral rules with third countries on mutual recognition of certification services could be beneficial;
(24) In order to increase user confidence in electronic communication and electronic commerce, certification-service-providers must observe data protection legislation and individual privacy;
(25) Provisions on the use of pseudonyms in certificates should not prevent Member States from requiring identification of persons pursuant to Community or national law;
(26) The measures necessary for the implementation of this Directive are to be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(7);
(27) Two years after its implementation the Commission will carry out a review of this Directive so as, inter alia, to ensure that the advance of technology or changes in the legal environment have not created barriers to achieving the aims stated in this Directive; it should examine the implications of associated technical areas and submit a report to the European Parliament and the Council on this subject;
(28) In accordance with the principles of subsidiarity and proportionality as set out in Article 5 of the Treaty, the objective of creating a harmonised legal framework for the provision of electronic signatures and related services cannot be sufficiently achieved by the Member States and can therefore be better achieved by the Community; this Directive does not go beyond what is necessary to achieve that objective,
Article 1
Scope
The purpose of this Directive is to facilitate the use of electronic signatures and to contribute to their legal recognition. It establishes a legal framework for electronic signatures and certain certification-services in order to ensure the proper functioning of the internal market.
It does not cover aspects related to the conclusion and validity of contracts or other legal obligations where there are requirements as regards form prescribed by national or Community law nor does it affect rules and limits, contained in national or Community law, governing the use of documents.
Article 2
Definitions
For the purpose of this Directive:
1. "electronic signature" means data in electronic form which are attached to or logically associated with other electronic data and which serve as a method of authentication;
2. "advanced electronic signature" means an electronic signature which meets the following requirements:
(a) it is uniquely linked to the signatory;
(b) it is capable of identifying the signatory;
(c) it is created using means that the signatory can maintain under his sole control; and
(d) it is linked to the data to which it relates in such a manner that any subsequent change of the data is detectable;
3. "signatory" means a person who holds a signature-creation device and acts either on his own behalf or on behalf of the natural or legal person or entity he represents;
4. "signature-creation data" means unique data, such as codes or private cryptographic keys, which are used by the signatory to create an electronic signature;
5. "signature-creation device" means configured software or hardware used to implement the signature-creation data;
6. "secure-signature-creation device" means a signature-creation device which meets the requirements laid down in Annex III;
7. "signature-verification-data" means data, such as codes or public cryptographic keys, which are used for the purpose of verifying an electronic signature;
8. "signature-verification device" means configured software or hardware used to implement the signature-verification-data;
9. "certificate" means an electronic attestation which links signature-verification data to a person and confirms the identity of that person;
10. "qualified certificate" means a certificate which meets the requirements laid down in Annex I and is provided by a certification-service-provider who fulfils the requirements laid down in Annex II;
11. "certification-service-provider" means an entity or a legal or natural person who issues certificates or provides other services related to electronic signatures;
12. "electronic-signature product" means hardware or software, or relevant components thereof, which are intended to be used by a certification-service-provider for the provision of electronic-signature services or are intended to be used for the creation or verification of electronic signatures;
13. "voluntary accreditation" means any permission, setting out rights and obligations specific to the provision of certification services, to be granted upon request by the certification-service-provider concerned, by the public or private body charged with the elaboration of, and supervision of compliance with, such rights and obligations, where the certification-service-provider is not entitled to exercise the rights stemming from the permission until it has received the decision by the body.
Article 3
Market access
1. Member States shall not make the provision of certification services subject to prior authorisation.
2. Without prejudice to the provisions of paragraph 1, Member States may introduce or maintain voluntary accreditation schemes aiming at enhanced levels of certification-service provision. All conditions related to such schemes must be objective, transparent, proportionate and non-discriminatory. Member States may not limit the number of accredited certification-service-providers for reasons which fall within the scope of this Directive.
3. Each Member State shall ensure the establishment of an appropriate system that allows for supervision of certification-service-providers which are established on its territory and issue qualified certificates to the public.
4. The conformity of secure signature-creation-devices with the requirements laid down in Annex III shall be determined by appropriate public or private bodies designated by Member States. The Commission shall, pursuant to the procedure laid down in Article 9, establish criteria for Member States to determine whether a body should be designated.
A determination of conformity with the requirements laid down in Annex III made by the bodies referred to in the first subparagraph shall be recognised by all Member States.
5. The Commission may, in accordance with the procedure laid down in Article 9, establish and publish reference numbers of generally recognised standards for electronic-signature products in the Official Journal of the European Communities. Member States shall presume that there is compliance with the requirements laid down in Annex II, point (f), and Annex III when an electronic signature product meets those standards.
6. Member States and the Commission shall work together to promote the development and use of signature-verification devices in the light of the recommendations for secure signature-verification laid down in Annex IV and in the interests of the consumer.
7. Member States may make the use of electronic signatures in the public sector subject to possible additional requirements. Such requirements shall be objective, transparent, proportionate and non-discriminatory and shall relate only to the specific characteristics of the application concerned. Such requirements may not constitute an obstacle to cross-border services for citizens.
Article 4
Internal market principles
1. Each Member State shall apply the national provisions which it adopts pursuant to this Directive to certification-service-providers established on its territory and to the services which they provide. Member States may not restrict the provision of certification-services originating in another Member State in the fields covered by this Directive.
2. Member States shall ensure that electronic-signature products which comply with this Directive are permitted to circulate freely in the internal market.
Article 5
Legal effects of electronic signatures
1. Member States shall ensure that advanced electronic signatures which are based on a qualified certificate and which are created by a secure-signature-creation device:
(a) satisfy the legal requirements of a signature in relation to data in electronic form in the same manner as a handwritten signature satisfies those requirements in relation to paper-based data; and
(b) are admissible as evidence in legal proceedings.
2. Member States shall ensure that an electronic signature is not denied legal effectiveness and admissibility as evidence in legal proceedings solely on the grounds that it is:
- in electronic form, or
- not based upon a qualified certificate, or
- not based upon a qualified certificate issued by an accredited certification-service-provider, or
- not created by a secure signature-creation device.
Article 6
Liability
1. As a minimum, Member States shall ensure that by issuing a certificate as a qualified certificate to the public or by guaranteeing such a certificate to the public a certification-service-provider is liable for damage caused to any entity or legal or natural person who reasonably relies on that certificate:
(a) as regards the accuracy at the time of issuance of all information contained in the qualified certificate and as regards the fact that the certificate contains all the details prescribed for a qualified certificate;
(b) for assurance that at the time of the issuance of the certificate, the signatory identified in the qualified certificate held the signature-creation data corresponding to the signature-verification data given or identified in the certificate;
(c) for assurance that the signature-creation data and the signature-verification data can be used in a complementary manner in cases where the certification-service-provider generates them both;
unless the certification-service-provider proves that he has not acted negligently.
2. As a minimum Member States shall ensure that a certification-service-provider who has issued a certificate as a qualified certificate to the public is liable for damage caused to any entity or legal or natural person who reasonably relies on the certificate for failure to register revocation of the certificate unless the certification-service-provider proves that he has not acted negligently.
3. Member States shall ensure that a certification-service-provider may indicate in a qualified certificate limitations on the use of that certificate. provided that the limitations are recognisable to third parties. The certification-service-provider shall not be liable for damage arising from use of a qualified certificate which exceeds the limitations placed on it.
4. Member States shall ensure that a certification-service-provider may indicate in the qualified certificate a limit on the value of transactions for which the certificate can be used, provided that the limit is recognisable to third parties.
The certification-service-provider shall not be liable for damage resulting from this maximum limit being exceeded.
5. The provisions of paragraphs 1 to 4 shall be without prejudice to Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts(8).
Article 7
International aspects
1. Member States shall ensure that certificates which are issued as qualified certificates to the public by a certification-service-provider established in a third country are recognised as legally equivalent to certificates issued by a certification-service-provider established within the Community if:
(a) the certification-service-provider fulfils the requirements laid down in this Directive and has been accredited under a voluntary accreditation scheme established in a Member State; or
(b) a certification-service-provider established within the Community which fulfils the requirements laid down in this Directive guarantees the certificate; or
(c) the certificate or the certification-service-provider is recognised under a bilateral or multilateral agreement between the Community and third countries or international organisations.
2. In order to facilitate cross-border certification services with third countries and legal recognition of advanced electronic signatures originating in third countries, the Commission shall make proposals, where appropriate, to achieve the effective implementation of standards and international agreements applicable to certification services. In particular, and where necessary, it shall submit proposals to the Council for appropriate mandates for the negotiation of bilateral and multilateral agreements with third countries and international organisations. The Council shall decide by qualified majority.
3. Whenever the Commission is informed of any difficulties encountered by Community undertakings with respect to market access in third countries, it may, if necessary, submit proposals to the Council for an appropriate mandate for the negotiation of comparable rights for Community undertakings in these third countries. The Council shall decide by qualified majority.
Measures taken pursuant to this paragraph shall be without prejudice to the obligations of the Community and of the Member States under relevant international agreements.
Article 8
Data protection
1. Member States shall ensure that certification-service-providers and national bodies responsible for accreditation or supervision comply with the requirements laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on tile protection of individuals with regard to the processing of personal data and on the free movement of such data(9).
2. Member States shall ensure that a certification-service-provider which issues certificates to the public may collect personal data only directly from the data subject, or after the explicit consent of the data subject, and only insofar as it is necessary for the purposes of issuing and maintaining the certificate. The data may not be collected or processed for any other purposes without the explicit consent of the data subject.
3. Without prejudice to the legal effect given to pseudonyms under national law, Member States shall not prevent certification service providers from indicating in the certificate a pseudonym instead of the signatory's name.
Article 9
Committee
1. The Commission shall be assisted by an "Electronic-Signature Committee", hereinafter referred to as "the committee".
2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at three months.
3. The Committee shall adopt its own rules of procedure.
Article 10
Tasks of the committee
The committee shall clarify the requirements laid down in the Annexes of this Directive, the criteria referred to in Article 3(4) and the generally recognised standards for electronic signature products established and published pursuant to Article 3(5), in accordance with the procedure laid down in Article 9(2).
Article 11
Notification
1. Member States shall notify to the Commission and the other Member States the following:
(a) information on national voluntary accreditation schemes, including any additional requirements pursuant to Article 3(7);
(b) the names and addresses of the national bodies responsible for accreditation and supervision as well as of the bodies referred to in Article 3(4);
(c) the names and addresses of all accredited national certification service providers.
2. Any information supplied under paragraph 1 and changes in respect of that information shall be notified by the Member States as soon as possible.
Article 12
Review
1. The Commission shall review the operation of this Directive and report thereon to the European Parliament and to the Council by 19 July 2003 at the latest.
2. The review shall inter alia assess whether the scope of this Directive should be modified, taking account of technological, market and legal developments. The report shall in particular include an assessment, on the basis of experience gained, of aspects of harmonisation. The report shall be accompanied, where appropriate, by legislative proposals.
Article 13
Implementation
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 19 July 2001. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive.
Article 14
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities
Article 15
Addressees
This Directive is addressed to the Member States.
|
[
"UKSI20020318"
] |
31999L0097
|
1999
|
Commission Directive 1999/97/EC of 13 December 1999 amending Council Directive 95/21/EC concerning the enforcement, in respect of shipping using Community ports and sailing in the waters under the jurisdiction of the Member States, of international standards for ship safety, pollution prevention and shipboard living and working conditions (port State control) (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 95/21/EC of 19 June 1995 concerning the enforcement, in respect of shipping using Community ports and sailing in the waters under the jurisdiction of the Member States, of international standards for ship safety, pollution prevention and shipboard living and working conditions (port State control)(1), as last amended by Directive 98/42/EC3(2), and in particular Article 19 thereof,
(1) Whereas it is necessary to take account of amendments which have entered into force to the conventions, protocols, codes and resolutions of the International Maritime Organisation (IMO), and developments within the Paris Memorandum of Understanding (Paris MOU);
(2) Whereas publication of information concerning ships detained in Community ports according to Directive 95/21/EC may be an incentive to their owners to take corrective action without being compelled to do so, and may raise the safety awareness in the shipping industry;
(3) Whereas to this end, the list of information to be published should be expanded, notably in order to include more detailed information on the ship involved, the detention and the action taken, as well as information on ships which have been refused access to Community ports; whereas it should be more clearly established where deficiencies which led to the detention of the vessel lie within the survey responsibilities of classification societies; whereas the efficiency of such measure should be enhanced through a more frequent publication of information, on a monthly basis;
(4) Whereas a better transparency on the data related to inspections of vessels is a necessary and important element for the promotion of quality in shipping both within the Community and worldwide; whereas the methods for making such information more widely and timely available should be defined in cooperation between the Member States and the Commission;
(5) Whereas Member States should take all necessary measures to remove any legal obstacle to the publication of the list of ships inspected, detained or being refused access to any port of the Community, in particular through the modification, where appropriate, of their national legislation concerning the protection of data;
(6) Whereas the overall targeting factor described in Annex I, Part II, to Directive 95/21lEC needs to be improved in the light of experience gained in its implementation; whereas the target factor value may be frequently adjusted within the framework of the Paris MOU and subsequently incorporated into the Sirenac system; whereas it is sufficient to consult the Sirenac database to know the value of the target factor of a vessel; whereas it appears consequently unnecessary to incorporate this value into Directive 95/21/EC;
(7) Whereas the list of certificates and documents referred to in Annex II to Directive 95/21/EC should be modified in order to take into account amendments which have entered into force to international legislation;
(8) Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee set up pursuant to Article 12 of Council Directive 93/75/EEC(3), as last amended by Commission Directive 98/74/EC(4),
Article 1
Directive 95/21/EC is amended as follows:
1. Article 2 shall be amended as follows:
(a) in point 1, the words "in force on 1 July 1998" shall be replaced by "in force on 1 July 1999";
(b) in point 2, the words "as it stands on 14 January 1998" shall be replaced by "as it stands on 1 July 1999".
2. Article 15 is replaced by the following: "Article 15
Release of information
1. The competent authority of each Member State shall take necessary measures in order to ensure that information listed in Annex VIII, Part I, concerning ships which have been detained in, or which are subject to refusal of access to, a port of this Member State during the previous month, is published at least every month.
2. The information available in the Sirenac system concerning ships inspected in ports of the Member States, referred to in Annex VIII, Part I and Part II, shall be made public, through appropriate technical arrangements, as soon as possible after the inspection has been completed, or the detention has been lifted.
3. Member States and the Commission shall cooperate in order to establish the appropriate technical arrangements referred to in paragraph 2.
4. Where appropriate, the Sirenac information system is amended in order to implement the abovementioned requirements."
3. Annex I is amended as provided for in the Annex to this Directive.
4. Annex II is amended as follows:
(a) Item 2, seventh indent, is replaced by the following: "- Exemption certificate, including, where appropriate, the list of cargoes."
(b) The following is inserted after Item 28: "29. Garbage management plan and garbage record book.
30. Decision support system for masters of passenger ships.
31. SAR cooperation plan for passenger ships trading on fixed routes.
32. List of operational limitations for passenger ships.
33. Bulk carrier booklet.
34. Loading and unloading plan for bulk carners."
5. A new Annex VIII is added as provided for in the Annex to this Directive.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 12 months after the adoption of this Directive. They shall immediately inform the Commission thereof.
When these provisions are adopted by Member States, they shall contain a reference to this Directive or shall be accompanied by such a reference at the time of their official publication. The procedure for making such a reference shall be laid down by Member States.
2. Member States shall communicate to the Commission the provisions of national law, which they adopt in the field covered by this Directive.
Article 3
The Directive shall enter into force on the seventh day following its publication in the Official Journal of the European Communities.
Article 4
The Directive is addressed to the Member States.
|
[
"UKSI20012349"
] |
31999L0092
|
1999
|
Directive 1999/92/EC of the European Parliament and of the Council of 16 December 1999 on minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres (15th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)
Having regard to the Treaty establishing the European Community, and in particular Article 137 thereof,
Having regard to the proposal from the Commission(1), submitted after consultation with the Advisory Committee on Safety, Hygiene and Health Protection at Work and the Safety and Health Commission for the Mining and Other Extractive Industries,
Having regard to the opinion of the Economic and Social Committee(2),
After consulting the Committee of the Regions,
Acting in accordance with the procedure referred to in Article 251 of the Treaty, in the light of the joint text approved by the Conciliation Committee on 21 October 1999(3),
Whereas:
(1) Article 137 of the Treaty provides that the Council may adopt, by means of Directives, minimum requirements for encouraging improvements, especially in the working environment, to guarantee a better level of protection of the health and safety of workers;
(2) Under the terms of that Article, those Directives are to avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings;
(3) The improvement of occupational safety, hygiene and health is an objective which should not be subordinated to purely economic considerations;
(4) Compliance with the minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres is essential if workers' safety and health protection is to be ensured;
(5) This Directive is an individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(4); therefore, the provisions of the said Directive, in particular those relating to worker information, to the consultation and participation of workers and to the training of workers, are also fully applicable to cases in which workers are potentially at risk from explosive atmospheres, without prejudice to more restrictive or specific provisions contained in this Directive;
(6) This Directive constitutes a practical step towards the achievement of the social dimension of the internal market;
(7) Directive 94/9/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres(5) states that it is intended to prepare an additional Directive based on Article 137 of the Treaty covering, in particular, explosion hazards which derive from a given use and/or types and methods of installation of equipment;
(8) Explosion protection is of particular importance to safety; whereas explosions endanger the lives and health of workers as a result of the uncontrolled effects of flame and pressure, the presence of noxious reaction products and consumption of the oxygen in the ambient air which workers need to breathe;
(9) The establishment of a coherent strategy for the prevention of explosions requires that organisational measures complement the technical measures taken at the workplace; Directive 89/391/EEC requires the employer to be in possession of an assessment of the risks to workers' health and safety at work; this requirement is to be regarded as being specified by this Directive in that it provides that the employer is to draw up an explosion protection document, or set of documents, which satisfies the minimum requirements laid down in this Directive and is to keep it up to date; the explosion protection document includes the identification of the hazards, the evaluation of risks and the definition of the specific measures to be taken to safeguard the health and safety of workers at risk from explosive atmospheres, in accordance with Article 9 of Directive 89/391/EEC; the explosion protection document may be part of the assessment of the risks to health and safety at work required by Article 9 of Directive 89/391/EEC;
(10) An assessment of explosion risks may be required under other Community acts; whereas, in order to avoid unnecessary duplication of work, the employer should be allowed, in accordance with national practice, to combine documents, parts of documents or other equivalent reports produced under other Community acts to form a single "safety report";
(11) The prevention of the formation of explosive atmospheres also includes the application of the substitution principle;
(12) Coordination should take place when workers from several undertakings are present at the same workplace;
(13) Preventive measures must be supplemented if necessary by additional measures which become effective when ignition has taken place; maximum safety can be achieved by combining preventive measures with other additional measures limiting the detrimental effects of explosions on workers;
(14) Council Directive 92/58/EEC of 24 June 1992 on the minimum requirements for the provision of safety and/or health signs at work (ninth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(6) is fully applicable, in particular to places immediately contiguous to hazardous areas, where smoking, crosscutting, welding and other activities introducing flames or sparks may interact with the hazardous area;
(15) Directive 94/9/EC divides the equipment and protective systems which it covers into equipment groups and categories; this Directive provides for a classification by the employer of the places where explosive atmospheres may occur in terms of zones and determines which equipment and protective systems groups and categories should be used in each zone,
SECTION I
GENERAL PROVISIONS
Article 1
Object and scope
1. This Directive, which is the 15th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC, lays down minimum requirements for the safety and health protection of workers potentially at risk from explosive atmospheres as defined in Article 2.
2. This Directive shall not apply to:
(a) areas used directly for and during the medical treatment of patients;
(b) the use of appliances burning gaseous fuels in accordance with Directive 90/396/EEC(7);
(c) the manufacture, handling, use, storage and transport of explosives or chemically unstable substances;
(d) mineral-extracting industries covered by Directive 92/91/EEC(8) or Directive 92/104/EEC(9);
(e) the use of means of transport by land, water and air, to which the pertinent provisions of the international agreements (e.g. ADNR, ADR, ICAO, IMO, RID), and the Community Directives giving effect to those agreements, apply. Means of transport intended for use in a potentially explosive atmosphere shall not be excluded.
3. The provisions of Directive 89/391/EEC and the relevant individual Directives are fully applicable to the domain referred to in paragraph 1, without prejudice to more restrictive and/or specific provisions contained in this Directive.
Article 2
Definition
For the purposes of this Directive, "explosive atmosphere" means a mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapours, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture.
SECTION II
OBLIGATIONS OF THE EMPLOYER
Article 3
Prevention of and protection against explosions
With a view to preventing, within the meaning of Article 6(2) of Directive 89/391/EEC, and providing protection against explosions, the employer shall take technical and/or organisational measures appropriate to the nature of the operation, in order of priority and in accordance with the following basic principles:
- the prevention of the formation of explosive atmospheres, or where the nature of the activity does not allow that,
- the avoidance of the ignition of explosive atmospheres, and
- the mitigation of the detrimental effects of an explosion so as to ensure the health and safety of workers.
These measures shall where necessary be combined and/or supplemented with measures against the propagation of explosions and shall be reviewed regularly and, in any event, whenever significant changes occur.
Article 4
Assessment of explosion risks
1. In carrying out the obligations laid down in Articles 6(3) and 9(1) of Directive 89/391/EEC the employer shall assess the specific risks arising from explosive atmospheres, taking account at least of:
- the likelihood that explosive atmospheres will occur and their persistence,
- the likelihood that ignition sources, including electrostatic discharges, will be present and become active and effective,
- the installations, substances used, processes, and their possible interactions,
- the scale of the anticipated effects.
Explosion risks shall be assessed overall.
2. Places which are or can be connected via openings to places in which explosive atmospheres may occur shall be taken into account in assessing explosion risks.
Article 5
General obligations
To ensure the safety and health of workers, and in accordance with the basic principles of risk assessment and those laid down in Article 3, the employer shall take the necessary measures so that:
- where explosive atmospheres may arise in such quantities as to endanger the health and safety of workers or others, the working environment is such that work can be performed safely,
- in working environments where explosive atmospheres may arise in such quantities as to endanger the safety and health of workers, appropriate supervision during the presence of workers is ensured in accordance with the risk assessment by the use of appropriate technical means.
Article 6
Duty of coordination
Where workers from several undertakings are present at the same workplace, each employer shall be responsible for all matters coming under his control.
Without prejudice to the individual responsibility of each employer as provided for in Directive 89/391/EEC, the employer responsible for the workplace in accordance with national law and/or practice shall coordinate the implementation of all the measures concerning workers' health and safety and shall state, in the explosion protection document referred to in Article 8, the aim of that coordination and the measures and procedures for implementing it.
Article 7
Places where explosive atmospheres may occur
1. The employer shall classify places where explosive atmospheres may occur into zones in accordance with Annex I.
2. The employer shall ensure that the minimum requirements laid down in Annex II are applied to places covered by paragraph 1.
3. Where necessary, places where explosive atmospheres may occur in such quantities as to endanger the health and safety of workers shall be marked with signs at their points of entry in accordance with Annex III.
Article 8
Explosion protection document
In carrying out the obligations laid down in Article 4, the employer shall ensure that a document, hereinafter referred to as the "explosion protection document", is drawn up and kept up to date.
The explosion protection document shall demonstrate in particular:
- that the explosion risks have been determined and assessed,
- that adequate measures will be taken to attain the aims of this Directive,
- those places which have been classified into zones in accordance with Annex I,
- those places where the minimum requirements set out in Annex II will apply,
- that the workplace and work equipment, including warning devices, are designed, operated and maintained with due regard for safety,
- that in accordance with Council Directive 89/655/EEC(10), arrangements have been made for the safe use of work equipment.
The explosion protection document shall be drawn up prior to the commencement of work and be revised when the workplace, work equipment or organisation of the work undergoes significant changes, extensions or conversions.
The employer may combine existing explosion risk assessments, documents or other equivalent reports produced under other Community acts.
Article 9
Special requirements for work equipment and workplaces
1. Work equipment for use in places where explosive atmospheres may occur which is already in use or is made available in the undertaking or establishment for the first time before 30 June 2003 shall comply from that date with the minimum requirements laid down in Annex II, Part A, if no other Community Directive is applicable or is so only partially.
2. Work equipment for use in places where explosive atmospheres may occur which is made available in the undertaking or establishment for the first time after 30 June 2003 shall comply with the minimum requirements laid down in Annex II, Parts A and B.
3. Workplaces which contain places where explosive atmospheres may occur and which are used for the first time after 30 June 2003 shall comply with minimum requirements set out in this Directive.
4. Where workplaces which contain places where explosive atmospheres may occur are already in use before 30 June 2003, they shall comply with the minimum requirements set out in this Directive no later than three years after that date.
5. If, after 30 June 2003, any modification, extension or restructuring is undertaken in workplaces containing places where explosive atmospheres may occur, the employer shall take the necessary steps to ensure that these comply with the minimum requirements set out in this Directive.
SECTION III
MISCELLANEOUS PROVISIONS
Article 10
Adjustments to the annexes
Purely technical adjustments to the annexes made necessary by:
- the adoption of Directives on technical harmonisation and standardisation in the field of explosion protection, and/or
- technical progress, changes in international regulations or specifications, and new findings on the prevention of and protection against explosions,
shall be adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC.
Article 11
Guide of good practice
The Commission shall draw up practical guidelines in a guide of good practice of a non-binding nature. This guide shall address the topics referred to in Articles 3, 4, 5, 6, 7 and 8, Annex I and Annex II, Part A.
The Commission shall first consult the Advisory Committee on Safety, Hygiene and Health Protection at Work in accordance with Council Decision 74/325/EEC(11).
In the context of the application of this Directive, Member States shall take the greatest possible account of the abovementioned guide in drawing up their national policies for the protection of the health and safety of workers
Article 12
Information to undertakings
Member States shall, on request, endeavour to make relevant information available to employers in accordance with Article 11, with particular reference to the guide of good practice
Article 13
Final provisions
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 30 June 2003. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the text of the provisions of domestic law which they have already adopted or adopt in the field governed by this Directive.
3. Member States shall report to the Commission every five years on the practical implementation of the provisions of this Directive, indicating the points of view of employers and workers. The Commission shall inform thereof the European Parliament, the Council, the Economic and Social Committee and the Advisory Committee on Safety, Hygiene and Health Protection at Work.
Article 14
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 15
This Directive is addressed to the Member States.
|
[
"UKSI20022776"
] |
31999L0104
|
1999
|
Commission Directive 1999/104/EC of 22 December 1999 amending the Annex to Council Directive 81/852/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 81/852/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products(1), as last amended by Directive 93/40/EEC(2), and in particular Article 2a(1) thereof,
(1) Whereas Commission Decision 987/534/EC of 30 July 1997 on the prohibition of the use of material presenting risks as regards transmissible spongiform encephalopathies(3), as amended by Council Decision 98/745/EC(4), defines specified risks materials, provides for their elimination at source and prohibits their import into the Community;
(2) Whereas, prior to being marketed, all veterinary medicinal products, whether they originate in the Community or are imported from third countries, are subject to an approval procedure in the context of which the treatment process of any raw material is evaluated, in conformity with the provisions of the Annex to Directive 81/852/EEC;
(3) Whereas this approval procedure applies to all veterinary medicinal products to be placed on the market in the Community, notwithstanding the origin of the product or the raw materials contained therein; whereas, thereby, the compliance with Community law on veterinary medicinal products, starting materials and intermediate products which are imported into the Community to be used in the manufacture of veterinary medicinal products is systematically controlled and checked;
(4) Whereas on 17 June 1999, the Committee for Veterinary Medicinal Products of the European Agency for the Evaluation of Medicinal Products adopted an updated Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via veterinary medicinal products.
(5) Whereas, in drafting this updated Note for Guidance, the Committee for Veterinary Medicinal Products of the European Agency for the evaluation of medicinal products took into account all relevant opinions of the Scientific Committee on Medicinal Products and Medical Devices, as well as the Scientific Steering Committee and additional scientific considerations which apply to the specific field of veterinary medicinal products;
(6) Whereas, the Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via veterinary medicinal products will have to be regularly updated and modified by the Committee for Veterinary Medicinal Products of the European Agency for the evaluation of medicinal products, taking into account the latest scientific developments;
(7) Whereas the note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via veterinary medicinal products and its updates are published by the European Commission in Volume 7 of its publication "The rules governing medicinal products in the European Union";
(8) Whereas this Note for Guidance is considered to be adquate to assure that the risk of transmitting animal spongiform encephalopathy via veterinary medicinal products is minimised since manufacturers of veterinary medicinal products are obliged under Directive 81/852/EEC to take into account the relevant Community guidelines in assembling the dossier for application for marketing authorisation;
(9) Whereas it contributes to the clarity of the legal situation and ensures the highest reasonable level of protection of animal and human health to amend the Annex to Directive 81/852/EEC to expressly made compliance with the above Note for Guidance binding within regard to all marketing authorisations for veterinary medicinal products and to provide for an appropriate phasing-in period for already existing marketing authorisations;
(10) Whereas the measures provided for in this Directive are in conformity with the opinion of the Standing Committee for Veterinary Medicinal Products,
Article 1
The Annex to Directive 81/852/EEC is hereby amended as shown in the Annex.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 1 January 2000.
2. Member States shall take the necessary measures to ensure that:
- applications for marketing authorisations for veterinary medicinal products lodged as from 1 October 2000 comply with the criteria set out in the Annex to this Directive;
- all marketing authorisations for veterinary medicinal products meet the criteria of the Annex to this Directive not later than 1 June 2001.
3. When the Member States adopt the provisions set out in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such references shall be adopted by the Member States.
4. The Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20000776"
] |
31999L0105
|
1999
|
Council Directive 1999/105/EC of 22 December 1999 on the marketing of forest reproductive material
Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,
Having regard to the Proposal from the Commission(1),
Having regard to the Opinion of the European Parliament(2),
Having regard to the Opinion of the Economic and Social Committee(3),
Whereas:
(1) Council Directive 66/404/EEC of 14 June 1966 on the marketing of forest reproductive material(4) and Council Directive 71/161/EEC of 30 March 1971 on external quality standards for forest reproductive material marketed within the Community(5) have been substantially amended several times; since further substantial amendments are to be made, the Directives should be combined and recast in the interests of clarity;
(2) Forests cover a large area of the Community and fulfil a multifunctional role based on their social, economic, environmental, ecological and cultural functions; there is a need for specific approaches and actions for the different types of forests, recognising the wide range of natural, social, economic and cultural conditions of the forests in the Community; both the restocking of these forests and new afforestation require a sustainable forest management in relation to the Forestry Strategy for the European Union as set out in the Council Resolution of 15 December 1998(6);
(3) Forest reproductive material of tree species and artificial hybrids which are important for forestry purposes should be genetically suited to the various site conditions and of high quality; the conservation and enhancement of biodiversity of the forests including the genetic diversity of the trees is essential to sustainable forest management;
(4) So far as they relate to plant health, harmonised conditions must be consistent with Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Member States of organisms harmful to plants or plant products and against their spread in the Community(7);
(5) Research on forestry has shown that, if forests are to be of increased value including the aspects of stability, adaptation, resistance, productivity and diversity, it is necessary to use reproductive material which is genetically and phenotypically suited to the site and of high quality; forestry seeds should meet, where appropriate, certain external quality standards;
(6) In the context of the consolidation of the internal market, it is necessary to remove any actual or potential barriers to trade which may hinder the free movement of forest reproductive material within the Community; it is in the interests of all the Member States that Community rules imposing the highest possible standards should be established;
(7) Community rules should refer to the phenotypic and genetic characteristics of seeds and plants and to the external quality of forest reproductive material;
(8) Such rules should apply to marketing both in other Member States and on domestic markets;
(9) Such rules should take account of practical needs and should apply only to those species and artificial hybrids which are important for forestry purposes in all or part of the Community;
(10) In some Member States the use of forest reproductive material of the category "source-identified", which was not approved for marketing by Directive 66/404/EEC, is traditional, compatible with the climate and indispensable for forestry purposes and it is therefore appropriate to approve for marketing such material in Member States wishing to do so; however it is inappropriate to impose the marketing to the end-user of such material in all Member States;
(11) Certain regions of the Community, such as the Alpine, Mediterranean or Nordic regions, have specific climatic conditions or vulnerable site conditions which justify particular requirements for the external quality of forest reproductive material of certain species;
(12) According to the General Declaration of the Third Ministerial Conference on the Protection of Forest in Europe in Lisbon, for reforestation and afforestation, origins of native species and local provenances that are well adapted to site conditions should be preferred;
(13) Reproductive material intended for export or re-export to third countries should not be covered by the measures set out in this Directive;
(14) As regards Community reproductive material, approval of basic material and, consequently, demarcations of regions of provenance are fundamental to selection; the Member States should apply uniform rules imposing the highest possible standards for the approval of basic material; only reproductive material derived from such material should be placed on the market;
(15) Genetically modified forest reproductive material should not be placed on the market unless it is safe for human health and the environment;
(16) An environmental risk assessment should be carried out on forest reproductive material consisting of genetically modified organisms; the Commission should then submit to the Council a proposal for a Regulation ensuring that the procedures for such environmental risk assessment and other relevant elements, including the authorisation procedure, are equivalent to those laid down in Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms(8); until such a Regulation enters into force, Directive 90/220/EEC should apply;
(17) Reproductive material satisfying the requirements of this Directive should be subject to no marketing restrictions other than those provided for in this Directive;
(18) Member States should, however, be authorised to provide that only such parts of plants and planting stock as conform to the standards laid down should be placed on the market in their territories;
(19) Member States should be permitted to impose additional or more stringent requirements for the approval of basic material produced in their own territory;
(20) The Member States should establish lists of regions of provenance specifying, where known, the origin of basic material; Member States should draw up maps showing the demarcations of the regions of provenance;
(21) Member States should draw up national registers of the basic material approved on their territory; a summary of the national register in the form of a national list should also be drawn up by each Member State;
(22) On the basis of such a national list, the Commission should ensure a Community publication;
(23) After harvesting, a master certificate should be issued by the official bodies for all reproductive material derived from approved basic material;
(24) It is necessary to ensure that, in addition to possessing the required phenotypic or genetic quality, reproductive material which is intended for marketing or which is placed on the market is properly identified from collection to delivery to the end user;
(25) Moreover, separate Community quality standards for stem cuttings and where appropriate for sets of poplar should be introduced;
(26) Seed should be marketed only if it conforms to certain quality standards and is contained in sealed packages;
(27) In order to ensure that requirements as to the phenotypic or genetic quality, proper identification and external quality standards are satisfied at the time of marketing, the Member States must make provision for appropriate control arrangements;
(28) Reproductive material satisfying those requirements must be subject only to such marketing restrictions as are provided for in Community rules; Member States should in certain circumstances be allowed to prohibit the marketing to the end user of forest reproductive material which is unsuitable for use in their territory;
(29) During periods in which there are temporary difficulties in obtaining supplies of certain species of reproductive material complying with the principles of this Directive, reproductive material satisfying less stringent requirements should, subject to certain conditions, be temporarily approved;
(30) Forest reproductive material coming from third countries should not be marketed within the Community unless it affords, as regards the approval of its basic material and the measures taken for its production, the same assurances as Community forest reproductive material; a master certificate or an official certificate issued by the country of origin as well as records which shall contain details of all consignments to be exported should accompany imported forest reproductive material when it is placed on the market within the Community;
(31) Under certain conditions, a Member State should be released wholly or partially from the provisions of this Directive in respect of certain tree species;
(32) It is desirable to organise temporary experiments for the purpose of seeking improved alternatives to certain provisions set out in this Directive;
(33) Community control measures should be introduced to ensure uniform application in all Member States of the requirements and conditions laid down in this Directive;
(34) Basically technical adjustments to the Annexes should be facilitated by an expeditious procedure;
(35) The measures necessary for the implementation of this instrument should be adopted in accordance with Council Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission(9);
(36) In the 1994 Treaty of Accession the Republic of Finland and the Kingdom of Sweden were granted a transitional period until 31 December 1999 for applying the Directive 66/404/EEC and the Republic of Finland also for applying Directive 71/161/EEC; this transitional period should be extended in order to allow the above mentioned countries to maintain their national schemes until the implementation date of this Directive at the latest,
Article 1
This Directive shall apply to the production with a view to marketing and to the marketing of forest reproductive material within the Community.
Article 2
For the purposes of this Directive the following definitions and/or classifications shall apply:
(a) Forest reproductive material:
reproductive material of those tree species and artificial hybrids thereof which are important for forestry purposes in all or part of the Community and in particular those which are listed in Annex I;
(b) Reproductive material means any of the following:
(i) Seed unit:
cones, infructescenses, fruits and seeds intended for the production of planting stock;
(ii) parts of plants:
stem cuttings, leaf cuttings and root cuttings, explants or embryos for micropropagation, buds, layers, roots, scions, sets and any parts of a plant intended for the production of planting stock;
(iii) planting stock:
plants raised from seed units, from parts of plants, or from plants from natural regeneration;
(c) Basic material means any of the following:
(i) Seed Source:
Trees within an area from which seed is collected;
(ii) Stand:
A delineated population of trees possessing sufficient uniformity in composition;
(iii) Seed Orchard:
A plantation of selected clones or families which is isolated or managed so as to avoid or reduce pollination from outside sources, and managed to produce frequent, abundant and easily harvested crops of seed;
(iv) Parents of Family:
Trees used to obtain progeny by controlled or open pollination of one identified parent used as a female, with the pollen of one parent (full-sibling) or a number of identified or unidentified parents (half sibling);
(v) Clone:
Group of individuals (ramets) derived originally from a single individual (ortet) by vegetative propagation, for example by cuttings, micropropagation, grafts, layers or divisions;
(vi) Clonal Mixture:
A mixture of identified clones in defined proportions.
(d) Autochthonous and indigenous means either of the following:
(i) Autochthonous stand or seed source:
An autochthonous stand or seed source is one which normally has been continuously regenerated by natural regeneration. The stand or seed source may be regenerated artificially from reproductive material collected in the same stand or seed source or autochthonous stands or seed sources within the close proximity;
(ii) Indigenous stand or seed source:
An indigenous stand or seed source is an autochthonous stand or seed source or is a stand or seed source raised artificially from seed, the origin of which is situated in the same region of provenance.
(e) Origin:
For an autochthonous stand or seed source, the origin is the place in which the trees are growing. For a non-autochthonous stand or seed source, the origin is the place from which the seed or plants were originally introduced. The origin of a stand or seed source may be unknown.
(f) Provenance:
The place in which any stand of trees is growing.
(g) Region of Provenance:
For a species or sub-species, the region of provenance is the area or group of areas subject to sufficiently uniform ecological conditions in which stands or seed sources showing similar phenotypic or genetic characters are found, taking into account altitudinal boundaries where appropriate.
(h) Production:
Production includes all stages in the generation of the seed unit, the conversion from seed unit to seed and the raising of planting stock from seed and parts of plants.
(i) Marketing:
Display with a view to sale, offering for sale, sale or delivery to another person including delivery under a service contract.
(j) Supplier:
Any natural or legal person engaged professionally in marketing or importing of forest reproductive material.
(k) Official body:
(i) an authority, established or designated by the Member State under the supervision of the national government and responsible for questions concerning the control of marketing and/or the quality of forest reproductive material;
(ii) any State authority established:
- either at national level, or
- at regional level, under the supervision of national authorities, within the limits set by the constitution of the Member State concerned.
The bodies referred to above may, in accordance with their national legislation, delegate the tasks provided for in this Directive to be accomplished under their authority and supervision to any legal person, whether governed by public or by private law, which, under its officially approved constitution, is charged exclusively with specific public functions, provided that such person, and its members, has no personal interest in the outcome of the measures it takes.
Moreover, in accordance with the procedure referred to in Article 26(2), other legal persons established on behalf of the body referred to in point (i) and acting under the authority and supervision of such body may be approved, provided that such person has no personal interest in the outcome of the measures it takes.
Member States shall notify the Commission of their responsible official bodies. The Commission shall forward that information to the other Member States.
(l) Forest reproductive material is divided into the following categories:
(i) "Source-identified"
Reproductive material derived from basic material which may be either a seed source or stand located within a single region of provenance and which meets the requirements set out in Annex II;
(ii) "Selected"
Reproductive material derived from basic material which shall be a stand located within a single region of provenance, which has been phenotypically selected at the population level and which meets the requirements set out in Annex III;
(iii) "Qualified"
Reproductive material derived from basic material which shall be seed orchards, parents of families, clones or clonal mixtures, the components of which have been phenotypically selected at the individual level, and which meets the requirements set out in Annex IV. Testing need not necessarily have been undertaken or completed;
(iv) "Tested"
Reproductive material derived from basic material which shall consist of stands, seed orchards, parents of families, clones or clonal mixtures. The superiority of the reproductive material must have been demonstrated by comparative testing or an estimate of the superiority of the reproductive material calculated from the genetic evaluation of the components of the basic material. The material shall meet the requirements set out in Annex V.
Article 3
1. The list of species and artificial hybrids in Annex I may be amended in accordance with the procedure referred to in Article 26(3).
2. Insofar as certain species and artificial hybrids are not subject to the measures contained in this Directive, Member States may take such measures, or less stringent measures, in respect of their own territory.
3. The measures contained in this Directive shall not apply to forest reproductive material in the form of planting stock or parts of plants, which is shown to be intended for purposes other than forestry.
In such cases, the material shall be accompanied by a label or other document required by other Community or national provisions which are applicable to such material for the intended purpose. In the absence of any such provisions, where a supplier handles both material intended for forestry purposes and material which is shown to be intended for purposes other than forestry, the latter shall be accompanied by a label or other document bearing the following statement: "Not for forestry purposes".
4. The measures contained in this Directive shall not apply to forest reproductive material which is shown to be intended for export or re-export to third countries.
Article 4
1. Member States shall provide that only approved basic material is used for the production of forest reproductive material which is to be marketed.
2. Basic material may only be approved by:
(a) the official bodies if it meets the requirements set out in Annexes II, III, IV or V hereto, as appropriate;
(b) reference to a unit known as "the unit of approval". Each unit of approval shall be identified by a unique register reference.
3. Member States shall provide that:
(a) approval shall be withdrawn if the requirements of this Directive are no longer met;
(b) after approval, the basic material for the production of reproductive material under the selected, qualified and tested categories shall be re-inspected at regular intervals.
4. In the interest of conserving plant genetic resources used in forestry as specified in specific conditions which shall be established in accordance with the procedure laid down in Article 26(3) to take account of developments in relation to the conservation in situ and the sustainable use of plant genetic resources through growing and marketing of forestry reproductive material of origin which are naturally adapted to the local and regional conditions and threatened by genetic erosion, the Member States may depart from the requirements as laid down in paragraph 2 and Annexes II, III, IV and V insofar as specific conditions are established in accordance with the procedure referred to in Article 26(3).
5. Member States may approve, for a maximum period of ten years, in all or part of their territory, basic material for the production of tested reproductive material where, from the provisional results of the genetic evaluation or comparative tests referred to in Annex V, it can be assumed that the basic material will, when tests have been completed, satisfy the requirements for approval under this Directive.
Article 5
1. If the basic material referred to in Article 4(1) consists of a genetically modified organism within the meaning of points 1 and 2 of Article 2 of Directive 90/220/EEC, such material shall only be accepted if it is safe for human health and the environment.
2. In the case of genetically modified basic material referred to in paragraph 1:
(a) an environmental risk assessment equivalent to that laid down in Directive 90/220/EEC shall be carried out;
(b) the procedures ensuring that the environmental risk assessment and other relevant elements are equivalent to those laid down in Directive 90/220/EEC shall be introduced on a proposal from the Commission, in a Regulation of the European Parliament and of the Council based on the appropriate legal basis in the Treaty. Until such Regulation enters into force, genetically modified basic material shall only be accepted for inclusion in the National Register under Article 10 of this Directive after having been authorised in accordance with Directive 90/220/EEC;
(c) Articles 11 to 18 of Directive 90/220/EEC shall no longer apply to genetically modified basic material authorised in conformity with the Regulation referred to in subparagraph (b);
(d) the technical and scientific details of the implementation of the environmental risk assessment shall be adopted in accordance with the procedure referred to in Article 26(3).
Article 6
1. Member States shall provide for forest reproductive material derived from approved basic material in the manner set out in points (a) to (d):
(a) Material of the species listed in Annex I shall not be marketed unless it is of the categories "source-identified", "selected", "qualified" or "tested" and meets the requirements of Annexes II, III, IV and V respectively,
(b) Material of the artificial hybrids listed in Annex I shall not be marketed unless it is of the "selected", "qualified" or "tested" categories and meets the requirements of Annexes III, IV and V respectively,
(c) Material of the species and artificial hybrids listed in Annex I which are vegetatively reproduced shall not be marketed unless it is of the "selected", "qualified" or "tested" categories and meets the requirements of Annexes III, IV and V respectively. In the case of reproductive material of the "selected" category, it may only be marketed if it has been mass propagated from seeds,
(d) Material of the species and artificial hybrids listed in Annex I, which consists wholly or partly of genetically modified organisms, shall not be marketed unless it is of the "tested" category and meets the requirements of Annex V.
2. The categories under which reproductive material from the different types of basic material may be marketed are as set out in the table in Annex VI.
3. Forest reproductive material of the species and artificial hybrids listed in Annex I shall not be marketed unless it meets the relevant requirements in Annex VII.
Parts of plants and planting stock may not be marketed unless they meet the requirements of prevailing international standards, once those standards are approved in accordance with the procedure referred to in Article 26(3).
4. Member States shall provide that suppliers of forest reproductive material are officially registered. The responsible official body may deem suppliers, who are already registered under Directive 77/93/EEC, to be registered for the purposes of this Directive. Such suppliers shall nonetheless comply with the requirements of this Directive.
5. Notwithstanding the provisions of paragraph 1, Member States may authorise suppliers on their own territory to place on the market appropriate quantities of:
(a) forest reproductive material for tests, scientific purposes, selection work or genetic conservation purposes; and
(b) seed units which are clearly shown not to be intended for forestry purposes.
6. The conditions under which Member States may grant the authorisations referred to in paragraph 5 may be determined in accordance with the procedure referred to in Article 26(3).
7. Without prejudice to paragraph 1 and in the case of reproductive material derived from basic material which does not meet all the requirements of the appropriate category mentioned in paragraph 1, Member States may authorise the marketing of such material subject to conditions to be drawn up in accordance with the procedure referred to in Article 26(3).
8. Specific provisions may be established in accordance with the procedure referred to in Article 26(3) to take account of developments under which forest reproductive material suitable for organic production may be marketed.
Article 7
Member States may, as regards the conditions laid down in Annexes II to V and VII, impose additional or more stringent requirements for the approval of basic material and production of reproductive material in their own territory.
Article 8
Member States may, in their territories, restrict the approval of basic material intended for the production of forest reproductive material of the category "source-identified".
Article 9
1. In the case of basic material intended for the production of reproductive material of the "source-identified" and "selected" categories, the Member States shall, for the relevant species, demarcate the regions of provenance.
2. Member States shall draw up and publish maps showing the demarcations of the regions of provenance. The maps shall be sent to the Commission and other Member States.
Article 10
1. Each Member State shall draw up a national register of the basic material of the various species approved on its territory. Full details of each unit of approval shall be recorded, together with its unique register reference, in the national register.
2. A summary of the national register in the form of a national list shall be drawn up by each Member State and shall be available on request to the Commission and the other Member States. The national list shall be presented in a common form for each unit of approval. For the categories "source-identified" and "selected", a summarisation of basic material based on regions of provenance is permitted. The following details shall be provided:
(a) botanical name;
(b) category;
(c) purpose;
(d) type of basic material;
(e) register reference or, where appropriate, summary thereof, or identity code for region of provenance;
(f) location: a short name, if appropriate, and any one of the following sets of particulars:
(i) for the "source-identified" category, region of provenance and the latitudinal and longitudinal range,
(ii) for the "selected" category, region of provenance and the geographical position defined by latitude and longitude or the latitudinal and longitudinal range,
(iii) for the "qualified" category, the exact geographical position(s) where the basic material is maintained,
(iv) for the "tested" category, the exact geographical position(s) where the basic material is maintained;
(g) altitude or altitudinal range;
(h) area: the size of a seed source(s), stand(s) or seed orchard(s);
(i) origin: it shall be stated whether the basic material is autochthonous/indigenous, non-autochthonous/non-indigenous or if the origin is unknown. For non-autochthonous/nonindigenous basic material, the origin shall be stated if known;
(j) in the case of material of the "tested" category, whether it is genetically modified.
3. The form in which such national lists shall be drawn up may be determined in accordance with the procedure referred to in Article 26(2).
Article 11
1. On the basis of the national list provided by each Member State, the Commission may publish a list entitled "Community List of Approved Basic Material for the Production of Forest Reproductive Material".
2. The Community list shall reflect the details given in the national lists referred to in Article 10(2) and show the area of utilisation and any authorisations or restrictions under Articles 8, 17 or 20.
Article 12
1. After harvesting, a master certificate showing the unique register reference shall be issued by the official bodies for all reproductive material derived from approved basic material, giving the relevant information set out in Annex VIII.
2. Where a Member State provides for subsequent vegetative propagation in accordance with Article 13(2), a new master certificate shall be issued.
3. Where mixing takes place in accordance with subparagraphs (a), (b), (c) or (e) of Article 13(3), Member States shall ensure that the register references of the components of the mixtures are identifiable, and a new master certificate or other document identifying the mixture shall be issued.
Article 13
1. Reproductive material shall, during all stages of production, be kept separated by reference to individual units of approval. Each lot of reproductive material shall be identified by the following:
(a) master certificate code and number;
(b) botanical name;
(c) category;
(d) purpose;
(e) type of basic material;
(f) register reference or identity code for region of provenance;
(g) region of provenance - for reproductive material of the "source-identified" and "selected" categories or other reproductive material if appropriate;
(h) if appropriate, whether the origin of the material is autochthonous or indigenous, non-autochthonous or non-indigenous, or unknown;
(i) in the case of seed units, the year of ripening;
(j) age and type of planting stock of seedlings or cuttings, whether undercuts, transplants or containerised;
(k) whether it is genetically modified.
2. Without prejudice to the provisions of paragraph 1 of this Article and of Article 6(1), point (c), Member States may provide for subsequent vegetative propagation of a single unit of approval in the "selected", "qualified" and "tested" categories. In such cases the material shall be kept separate and identified as such.
3. Without prejudice to the provisions of paragraph 1, Member States may provide:
(a) within a single region of provenance, for mixing of reproductive material derived from two or more units of approval within the "source-identified" category or within the "selected" category;
(b) when mixing of reproductive material within a single region of provenance, from seed sources and stands in the "source-identified" category takes place, that the new combined lot will be certified as "reproductive material derived from a seed source";
(c) when mixing of reproductive material derived from non-autochthonous or non-indigenous basic material with that from basic material of unknown origin takes place, that the new combined lot will be certified as being "of unknown origin";
(d) when mixing takes place in accordance with subparagraphs (a), (b) or (c) that the identity code for the region of provenance may be substituted for the register reference as in paragraph 1(f);
(e) for mixing of reproductive material derived from a single unit of approval from different years of ripening;
(f) when mixing takes place in accordance with subparagraph (e) that the actual years of ripening and proportion of material from each year shall be recorded.
Article 14
1. Reproductive material may be marketed only in lots which comply with Article 13 and are accompanied by a label or other document from the supplier ("the supplier's label or document") giving, in addition to the information required under Article 13, the following information:
(a) master certificate number(s) issued under Article 12 or reference to the other document available according to Article 12(3);
(b) name of supplier;
(c) quantity supplied;
(d) in the case of reproductive material of the "tested" category whose basic material is approved under Article 4(5), the words "provisionally approved";
(e) whether the material has been vegetatively propagated.
2. In the case of seeds, the supplier's label or document referred to in paragraph 1 shall also include the following additional information, assessed, as far as possible, by internationally accepted techniques:
(a) purity: the percentage by weight of pure seed, other seed and inert matter of the product marketed as a seed lot;
(b) the germination percentage of the pure seed, or, where germination percentage is impossible or impractical to assess, the viability percentage assessed by reference to a specified method;
(c) the weight of 1000 pure seeds;
(d) the number of germinable seeds per kilogram of product marketed as seed, or, where the number of germinable seeds is impossible or impractical to assess, the number of viable seeds per kilogram.
3. In order to make seed of the current seasons crop rapidly available, notwithstanding the fact that the examination in respect of germination as laid down in paragraph 2(b) has not been concluded, Member States may authorise marketing as far as to the first buyer. The respect of the conditions as laid down in paragraph 2(b) and (d) shall be stated by the supplier as soon as possible.
4. In the case of small quantities of seed, the requirements as laid down in paragraph 2(b) and (d) above do not apply. The quantities and conditions may be determined in accordance with the procedure referred to in Article 26(2).
5. In the case of Populus spp., parts of plants shall only be marketed if the EC classification number according to point 2(b) of Annex VII, Part C is given on the supplier's label or document.
6. If a coloured label or document is used in respect of any category of forest reproductive material, the colour of the supplier's label or document shall be yellow in the case of "source-identified" reproductive material, green in the case of "selected" reproductive material, pink in the case of "qualified" reproductive material and blue in the case of "tested" reproductive material.
7. In the case of forest reproductive material derived from basic material which consists of a genetically modified organism, any label or document, official or otherwise, for the lot shall clearly indicate that fact.
Article 15
Seed units shall be marketed only in sealed packages. The sealing device shall be such as will become unserviceable when the package is opened.
Article 16
1. The Member States shall, by an official control system set up or approved by them, ensure that reproductive material from individual units of approval or lots remains clearly identifiable through the entire process from collection to delivery to the end user. Official inspections of registered suppliers shall be carried out regularly.
2. Member States shall ensure that the respective official bodies assist each other administratively in order to obtain appropriate information necessary to ensure the proper functioning of this Directive, particularly where forest reproductive material moves from one Member State to another.
3. Suppliers shall provide official bodies with records, which shall contain details of all consignments detained and marketed.
4. Detailed rules for the application of paragraph 2 shall be drawn up in accordance with the procedure referred to in Article 26(2) no later than 30 June 2002.
5. Member States shall take all measures to ensure compliance with the provisions of this Directive by making suitable arrangements for forest reproductive material to be officially controlled during production with a view to marketing and marketing.
6. Experts from the Commission may, in cooperation with the official bodies of the Member States, make on-the-spot checks so far as this is necessary to ensure uniform application of this Directive. They may in particular verify whether forest reproductive material is complying with the requirements of this Directive. A Member State in whose territory a check is being carried out shall give all necessary assistance to the experts in carrying out their duties. The Commission shall inform the Member States of the results of the investigation.
Article 17
1. Member States shall ensure that reproductive material which is placed on the market in accordance with the provisions of this Directive shall not be subject to any marketing restrictions as regards its characteristics, examination and inspection requirements, labelling and sealing other than those laid down in this Directive.
2. Upon its application, a Member State may be authorised, pursuant to the procedure referred to in Article 26(3), to prohibit the marketing to the end user with a view to seeding or planting in all or part of its territory of specified reproductive material.
Such authorisation shall be granted only where there is reason to believe:
(a) that the use of the said reproductive material would, on account of its phenotypic or genetic characteristics, have an adverse effect on forestry, environment, genetic resources or biodiversity in all or part of that Member State on the basis of
- evidence relating to the region of provenance or the origin of the material or,
- results of trials or scientific research carried out in appropriate locations, either within or outside the Community.
(b) on the basis of known results of trials, scientific research, or the results obtained from forestry practice concerning survival and development of planting stock in relation to morphological and physiological characteristics that the use of the said reproductive material would, on account of its characteristics have an adverse effect on forestry, environment, genetic resources or biodiversity in all or part of that Member State.
3. Detailed rules for the application of paragraph 2 shall be drawn up in accordance with the procedure referred to in Article 26(3).
4. Without prejudice to paragraph 1, Member States which have implemented Article 8 in respect of the forest reproductive material of the category source identified may prohibit the marketing to the end user of such material.
Article 18
1. In order to remove any temporary difficulties in the general supply to the end user of forest reproductive material satisfying the requirements of this Directive that occur in one or more Member States and cannot be overcome within the Community, the Commission shall, at the request of at least one Member State affected and in accordance with the procedure referred to in Article 26(2), authorise one or more Member States to approve for marketing, for a period to be set by the Commission, forest reproductive material of one or more species which satisfies less stringent requirements.
Where such action is taken, the suppliers' labels or documents required under Article 14(1) shall state that the material in question satisfies less stringent requirements.
2. Detailed rules for the application of paragraph 1 may be drawn up in accordance with the procedure referred to in Article 26(2).
Article 19
1. The Council, acting by a qualified majority on a proposal from the Commission, shall determine whether forest reproductive material produced in a third country affords the same assurances as regards the approval of its basic material and the measures taken for its production with a view to marketing as does forest reproductive material produced within the Community and complying with the provisions of this Directive.
2. In addition to the matters referred to in paragraph 1, the Council shall determine the species, type of basic material and categories of forest reproductive material, together with its region of provenance, which may be permitted to be marketed under paragraph 1 within the Community.
3. Until such time as the Council has taken a decision under paragraph 1, the Member States may, in accordance with the procedure referred to in Article 26(3), be authorised to take such decisions. Such authorisation shall aim at ensuring that the material to be imported affords equivalent guarantees in all respects to forest reproductive material produced in the Community in accordance with this Directive. In particular such imported material shall be accompanied by a master certificate or an official certificate issued by the country of origin and records which shall contain details of all consignments to be exported, to be provided by the supplier in the third country.
Article 20
Upon application by a Member State, the Commission, acting in accordance with the procedure referred to in Article 26(3), may release a Member State wholly or partially from the provisions of this Directive in respect of certain tree species which are not important for forestry purposes in that Member State, save where this would run counter to the provisions of Article 17(1).
Article 21
For the purpose of seeking improved alternatives to certain provisions set out in this Directive, it may be decided to organise temporary experiments under specified conditions at Community level in accordance with the procedure referred to in Article 26(3).
The duration of an experiment shall not exceed seven years.
In the context of such experiments, Member States may be released from certain obligations laid down in this Directive. The extent of that release shall be defined with reference to the provisions to which it applies.
Article 22
Forest reproductive material shall, where applicable, comply with the relevant plant health conditions laid down in Directive 77/93/EEC.
Article 23
Any amendments to be made to the Annexes in the light of the development of scientific or technical knowledge shall be adopted according to the procedure referred to in Article 26(3).
Article 24
The measures necessary for the implementation of this Directive relating to the matters contained in the Articles referred to below shall be adopted in accordance with the management procedure referred to in Article 26(2).
- Articles 2, 10, 14, 16, 18, 27.
Article 25
The measures necessary for the implementation of this Directive relating to the matters contained in the Articles referred to below shall be adopted in accordance with the regulatory procedure referred to in Article 26(3).
- Articles 3, 4, 5, 6, 17, 19, 20, 21 and 23.
Article 26
1. The Commission shall be assisted by the Standing Committee on Seeds (hereinafter referred to as "the Committee").
2. Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply.
The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month.
3. When reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at two months.
4. The Committee shall adopt its rules of procedure.
Article 27
1. For a transitional period not exceeding 10 years from 1 January 2003, Member States may use, for the purpose of approving basic material for the production of tested reproductive material - not previously covered by Directive 66/404/EEC - the results of comparative tests which do not satisfy the requirements laid down in Annex V.
Such tests shall have begun before 1 January 2003, and must have shown that the reproductive material derived from the basic material is superior.
2. For a transitional period not exceeding 10 years from 1 January 2003, Member States may use, for the purpose of approving basic material for the production of tested reproductive material of all species and artificial hybrids covered by this Directive, the results of genetic evaluation tests which do not satisfy the requirements laid down in Annex V.
Such tests shall have begun before 1 January 2003, and must have shown that the reproductive material derived from the basic material is superior.
3. In the case of new species and artificial hybrids which may be added to Annex I at a later date, the transitional period referred to in paragraphs 1 and 2 shall be fixed in accordance with the procedure referred to in Article 26(2).
4. Member States may, in accordance with the procedure referred to in Article 26(2), be authorised to use the results of comparative tests and genetic evaluation tests after expiry of the transitional period.
Article 28
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 1 January 2003. They shall forthwith inform the Commission thereof.
When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the text of the main provisions of domestic law they adopt in the field covered by this Directive.
3. The Member States shall be allowed to market until exhaustion stocks of forest reproductive material accumulated before 1 January 2003.
Article 29
Directive 66/404/EEC and Directive 71/161/EEC are hereby repealed with effect from 1 January 2003.
Directive 66/404/EEC shall not apply to the Republic of Finland and the Kingdom of Sweden and Directive 71/161/EEC shall not apply to the Republic of Finland.
References to the repealed Directives shall be construed as references to this Directive and should be read in accordance with the correlation table set out in Annex IX.
Article 30
This Directive shall enter into force on the date of its publication in the Official Journal of the European Communities.
Article 31
This Directive is addressed to the Member States.
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[
"UKSI20023026"
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|
2000
|
Commission Directive 2000/2/EC of 14 January 2000 adapting to technical progress Council Directive 75/322/EEC relating to the suppression of radio interference produced by spark-ignition engines fitted to wheeled agricultural or forestry tractors and Council Directive 74/150/EEC relating to the type-approval of wheeled agricultural or forestry tractors (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors(1), as last amended by European Parliament and Council Directive 97/54/EC(2), and in particular Article 11 thereof,
Having regard to Council Directive 75/322/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to the suppression of radio interference produced by spark-ignition engines fitted to wheeled agricultural or forestry tractors(3), as last amended by Directive 97/54/EC, and in particular Article 5 thereof,
Whereas:
(1) Directive 75/322/EEC is one of the separate directives of the EC type-approval procedure which was established pursuant to Directive 74/150/EEC. Consequently, the provisions laid down in Directive 74/150/EEC applicable to systems, components and separate technical units apply to Directive 75/322/EEC.
(2) Directive 75/322/EEC contains the earliest measures endeavouring to bring about a basic electromagnetic compatibility regarding radio interference. Subsequently, technical progress has increased the complexity and diversity of electrical and electronic equipment.
(3) To take account of the increasing concern about the technological developments in electrical and electronic equipment and the need to ensure the general compatibility of different electrical and electronic equipment, Council Directive 89/336/EEC(4), as last amended by Directive 93/68/EEC(5), laid down general provisions regarding electromagnetic compatibility for all products not covered by a specific directive.
(4) Directive 89/336/EEC established the principle that, in so far as protection requirements specified in that Directive were harmonised, its general provisions would not apply or would cease to apply with regard to apparatus covered by specified directives.
(5) Directive 75/322/EEC should become such a specific directive.
(6) The adaptation to technical progress was effected, in the case of motor vehicles, by Commission Directive 95/54/EC(6) relating to the suppression of radio interference produced by spark-ignition engines fitted to motor vehicles. Equivalent requirements must now be adopted on the suppression of radio interference produced by engines fitted to agricultural or forestry tractors, by establishing a specific directive within the framework of the type-approval procedure which provides for approvals granted by designated national authorities on the basis of harmonised technical requirements.
(7) From 1 October 2001 the technical requirements relating to the radio interference (electromagnetic compatibility) of vehicles, their components and systems should be governed solely by the provisions of Directive 75/322/EEC.
(8) The measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Article 12 of Directive 74/150/EEC,
Article 1
Directive 75/322/EEC is amended as follows:
1. The title is replaced by the following: "Council Directive 75/322/EEC of 20 May 1975 on the suppression of radio interference produced by agricultural or forestry tractors (electromagnetic compatibility)."
2. Articles 1 and 2 are replaced by the following: "Article 1
For the purposes of this Directive, 'vehicle' means any vehicle as defined in Directive 74/150/EEC.
Article 2
No Member State may refuse to grant EC type-approval or national type-approval to a vehicle, system, component or separate technical unit on grounds relating to electromagnetic compatibility if the requirements of this Directive are fulfilled."
3. Article 3 is deleted.
4. Article 4 is replaced by the following: "Article 4
This Directive shall constitute a 'specific directive' for the purposes of Article 2(2) of Council Directive 89/336/EEC(7) with effect from 1 October 2001."
5. The Annexes shall be replaced by Annexes I to IX to Directive 95/54/EC, subject to the amendments set out in the Annex to this Directive.
Article 2
1. With effect from 1 January 2001, Member States may not, on grounds relating to electromagnetic compatibility:
- refuse to grant EC type-approval or national type-approval in respect of any given type of vehicle,
- refuse to grant EC component or technical unit type-approval in respect of any given type of component or separate technical unit,
- prohibit the registration, sale or entry into service of vehicles,
- prohibit the sale or use of components or separate technical units,
if the vehicles, components or separate technical units comply with the requirements of Directive 75/322/EEC, as amended by this Directive.
2. With effect from 1 October 2002, Member States:
- may no longer grant EC vehicle type-approval, EC component type-approval or EC separate technical unit type-approval,
and
- may refuse to grant national type-approval,
for any type of vehicle component or separate technical unit, if the requirements of Directive 75/322/EEC, as amended by this Directive, are not fulfilled.
3. Paragraph 2 shall not apply to vehicle types approved before 1 October 2002 pursuant to Council Directive 77/537/EEC(8) nor to any subsequent extensions to these approvals.
4. With effect from 1 October 2008, Member States:
- shall consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 74/150/EEC to be no longer valid for the purposes of Article 7(1) of that Directive,
and
- may refuse the sale and entry into service of new electrical or electronic sub-assemblies as components or separate technical units,
if the requirements of this Directive are not fulfilled.
5. Without prejudice to paragraphs 2 and 4, in the case of replacement parts, Member States shall continue to grant EC type-approval and to permit the sale and entry into service of components or separate technical units intended for use on vehicle types which have been approved before 1 October 2002 pursuant to Directive 75/322/EEC or Directive 77/537/EEC and, where applicable, subsequent extensions to these approvals.
Article 3
In point 3.17 of Annex I and point 2.4 of Annex II to Directive 74/150/EEC, "interference suppressor" is replaced by "electromagnetic compatibility".
Article 4
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2000 at the latest. They shall forthwith inform the Commission thereof.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.
Article 5
This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.
Article 6
This Directive is addressed to the Member States.
|
[
"UKSI20011710"
] |
32000L0001
|
2000
|
Commission Directive 2000/1/EC of 14 January 2000 adapting to technical progress Council Directive 89/173/EEC as regards certain components and characteristics of wheeled agricultural or forestry tractors (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors(1), as last amended by European Parliament and Council Directive 97/54/EC(2), and in particular Article 11 thereof,
Having regard to Council Directive 89/173/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to certain components and characteristics of wheeled agricultural or forestry tractors(3), as last amended by Directive 97/54/EC, and in particular Article 9 thereof,
Whereas:
(1) In order to take account of technical progress, it is now necessary to revise certain provisions concerning dimensions and masses, and in particular those of the mechanical couplings, in order to make the best possible use of ISO standards; and, in order to improve safety, the testing arrangements should be specified in Directive 89/173/EEC, for all possible configurations.
(2) The provisions of this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Article 12 of Directive 74/150/EEC,
Article 1
Annexes I, II, IV and V to Directive 89/173/EEC are hereby amended as set out in the Annex to this Directive.
Article 2
1. From 1 July 2000, Member States may not:
- refuse to grant EC type-approval, to issue the document provided for in the third indent of Article 10(1) of Directive 74/150/EEC, or to grant national type-approval, in respect of a type of tractor, or
- prohibit the entry into service of tractors,
if the tractors in question meet the requirements of Directive 89/173/EEC, as amended by this Directive.
2. From 1 January 2001, Member States:
- may no longer issue the document provided for in the third indent of Article 10(1) of Directive 74/150/EEC in respect of a type of tractor which does not meet the requirements of Directive 89/173/EEC, as amended by this Directive,
- may refuse to grant national type-approval in respect of a type of tractor which does not meet the requirements of Directive 89/173/EEC, as amended by this Directive.
Article 3
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 2000 at the latest. They shall forthwith inform the Commission thereof.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of domestic law that they adopt in the field governed by this Directive.
Article 4
This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.
Article 5
This Directive is addressed to the Member States.
|
[
"UKSI20011710"
] |
32000L0003
|
2000
|
Commission Directive 2000/3/EC of 22 February 2000 adapting to technical progress Council Directive 77/541/EEC relating to safety belts and restraint systems of motor vehicles (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers(1), as last amended by Directive 98/91/EC of the European Parliament and of the Council(2),
Having regard to Council Directive 77/541/EEC of 28 June 1977 on the approximation of the laws of the Member States relating to safety belts and restraint systems of motor vehicles(3), as last amended by Commission Directive 96/36/EC(4), and in particular Article 10 thereof,
Whereas:
(1) Directive 77/541/EEC is one of the separate directives of the EC type-approval procedure which has been established by Directive 70/156/EEC. Consequently, the provisions laid down in Directive 70/156/EEC relating to vehicle systems, components and separate technical units apply to Directive 77/541/EEC.
(2) In the light of technical progress it is possible to improve the protection provided for passengers by requiring the installation of three-point belts with retractors for all seats of motor vehicles of category M1.
(3) By Council Decision 97/836/EC(5), the Community acceded to the United Nations Economic Commission for Europe (ECE) Agreement concerning the adoption of uniform technical prescriptions for wheeled vehicles, equipment and parts which can be fitted and/or used on wheeled vehicles and the conditions for reciprocal recognition of approvals granted on the basis of these prescriptions, done at Geneva on 20 March 1958, as revised on 16 October 1995.
(4) With its accession to the revised Agreement, the Community acceded to a defined list of regulations established pursuant to that Agreement. That list includes UN/ECE Regulation No 44 concerning the approval of restraining devices for child occupants of power-driven vehicles (child restraint system).
(5) It is expedient to include requirements relating to the protection of children and therefore amend the Annexes to Directive 77/541/EEC by incorporating specific requirements for child restraint systems based on UN/ECE Regulation No 44. For the sake of clarity the full text of the Annexes to Directive 77/541/EEC should be replaced.
(6) The measures provided for in this Directive are in accordance with the opinion of the Committee on the adaptation to technical progress established by Directive 70/156/EEC,
Article 1
The Annexes to Directive 77/541/EEC are replaced by the texts set out in the Annex to this Directive.
Article 2
1. With effect from 1 October 2000, no Member State may, on grounds relating to safety belts and restraint systems:
- refuse, in respect of a type of motor vehicle, safety belt, restraint system or child restraint system, to grant EC type-approval, or national type-approval, or
- prohibit the registration, sale or entry into service of vehicles, or the sale or entry into service of safety belts, restraint systems or child restraint systems,
if the safety belts and restraint systems or child restraint systems in question meet the requirements of Directive 77/541/EEC as amended by this Directive.
2. With effect from 1 October 2001 Member States:
- shall no longer grant EC type-approval, and
- may refuse to grant national type-approval,
for a type of vehicle, if the requirements of Directive 77/541/EEC as amended by this Directive as regards child restraint systems and the installation of safety belts in all seating positions in M1 vehicles including, where fitted, integrated child restraint systems, are not fulfilled.
However, the requirement for three-point belts in all seating positions in M1 vehicles shall apply with effect from 1 April 2002. Until this date, the seat belt fitment requirements for M1 vehicles shall be those prescribed in Annex XV to Directive 77/541/EEC.
3. With effect from 1 October 2002, Member States:
- shall consider certificates of conformity which accompany new vehicles of category M1 pursuant to Directive 70/156/EEC as no longer valid for the purpose of Article 7(1) of that Directive and refuse the registration, sale or entry into service of new vehicles which are not accompanied by a valid certificate of conformity pursuant to Directive 70/156/EEC, except where the provisions of Article 8(2) of that Directive are invoked,
- may refuse the registration, sale or entry into service of new vehicles of category N1 and M2 having a mass not greater than 3,5 tonnes as regards, when fitted, integrated child restraint systems,
on grounds relating to safety belts and restraint systems if the requirements of Directive 77/541/EEC as amended by this Directive are not fulfilled.
However, the requirement for three-point belts in all seating positions in M1 vehicles shall apply with effect from 1 October 2004. Until this date, the seat belt fitment requirements for M1 vehicles shall be those prescribed in Annex XV to Directive 77/541/EEC.
4. With effect from 1 January 2001 the requirements of Directive 77/541/EEC as amended by this Directive relating to integrated child restraint systems, where fitted as original equipment to a vehicle, shall apply for the purposes of Article 7(1) of Directive 70/156/EEC.
Article 3
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 2000 at the latest. They shall forthwith inform the Commission thereof.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 4
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 5
This Directive is addressed to the Member States.
|
[
"UKSI20011710",
"UKSI20002730"
] |
32000L0004
|
2000
|
Directive 2000/4/EC of the European Parliament and of the Council of 28 February 2000 amending Council Directive 74/60/EEC on the approximation of the laws of the Member States relating to the interior fittings of motor vehicles (interior parts of the passenger compartment other than the interior rear-view mirrors, layout of controls, the roof or sliding roof, the backrest and rear part of the seats)
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),
Whereas:
(1) It is desirable to introduce into Council Directive 74/60/EEC(4), requirements concerning power-operated windows with the aim of eliminating the danger to children, which can occur when closing these windows; similar requirements should also apply to power-operated roof panel systems and partition systems; for this purpose the title and the scope of Directive 74/60/EEC should be amended accordingly.
(2) Directive 74/60/EEC is one of the separate directives of the EC type-approval procedure which has been established by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers(5); consequently, the provisions laid down in Directive 70/156/EEC relating to vehicles, vehicle systems, components and separate technical units apply to Directive 74/60/EEC.
(3) In particular, Articles 3(4) and 4(3) of Directive 70/156/EEC require that each separate Directive has attached to it an information document incorporating the relevant items of Annex I to Directive 70/156/EEC and also a type-approval certificate based on Annex VI to Directive 70/156/EEC in order that type-approval may be computerised.
(4) It is important that vehicles in categories other than M1, in particular those in categories M2 and N1, are able at the earliest opportunity to afford the driver and passengers, more particularly children, the level of safety provided by Directive 74/60/EEC; to that end it should be made possible for the scope of Directive 74/60/EEC to be extended to cover such vehicles in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC.
(5) The amendments to Directive 74/60/EEC relate only to its administrative provisions and to power-operated windows, roof panel and/or partition systems; it is not necessary therefore to invalidate existing approvals granted under Directive 74/60/EEC nor to prevent the registration, sale and entry into service of new vehicles, which are not fitted with power-operated windows, roof panel and/or partition systems and which are covered by such approvals.
(6) In accordance with the principle of proportionality as set out in the third paragraph of Article 5 of the Treaty, the measures contained in this Directive do not go beyond what is necessary to achieve the objectives of the Treaty,
Article 1
Directive 74/60/EEC is hereby amended as follows:
1. The title shall be replaced by the following:
"Council Directive 74/60/EEC of 17 December 1973 on the approximation of the laws of the Member States relating to the interior fittings of motor vehicles."
2. Articles 1, 2 and 3 shall be replaced by the following:
"Article 1
For the purpose of this Directive, 'vehicle' means any vehicle as defined in Article 2 of Directive 70/156/EEC.
Article 2
No Member State may refuse to grant EC type-approval or national type-approval of a vehicle on grounds relating to the interior fittings of the vehicles if these meet the requirements set out in the Annexes hereto.
Article 3
No Member State may refuse to register or prohibit the sale, entry into service or use of any vehicle on grounds relating to the interior fittings of the vehicles if these meet the requirements set out in the Annexes."
3. Articles 4 and 5 shall be deleted.
4. The Annexes shall be amended in accordance with the Annex to this Directive.
Article 2
1. With effect from 8 April 2001, Member States may not, on grounds relating to the interior fittings of the motor vehicles,
- refuse, in respect of a type of vehicle, to grant EC type-approval or national type-approval, or
- prohibit the registration, sale or entry into service of vehicles,
if the vehicles comply with the requirements of Directive 74/60/EEC.
2. With effect from 8 April 2002, Member States shall no longer grant EC type-approval for a new type of vehicle on grounds relating to the interior fittings of the motor vehicles if the requirements of Directive 74/60/EEC are not complied with.
3. With effect from 8 April 2003, Member States:
- shall consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 70/156/EEC to be no longer valid for the purposes of Article 7(1) of that Directive, and
- may refuse the registration, sale and entry into service of new vehicles which are not accompanied by a certificate of conformity unless Article 8(2) of Directive 70/156/EEC is invoked,
on grounds relating to the interior fittings of motor vehicles if the vehicles are fitted with power-operated windows, roof panel and/or partition systems and the requirements of Directive 74/60/EEC, are not complied with.
4. This Directive will not invalidate any approval for types of vehicles which are not fitted with power-operated windows, roof panel and/or partition systems previously granted under Directive 74/60/EEC nor prevent extensions of such approvals under the terms of the Directive under which they where originally granted.
Article 3
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 8 April 2001 and shall forthwith inform the Commission thereof.
2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
3. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.
Article 4
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 5
This Directive is addressed to the Member States.
|
[
"UKSI20002730"
] |
32000L0009
|
2000
|
Directive 2000/9/EC of the European Parliament and of the Council of 20 March 2000 relating to cableway installations designed to carry persons
Having regard to the Treaty establishing the European Community, and in particular Article 47(2) and Articles 55 and 95 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),
Whereas:
(1) Cableway installations designed to carry persons (hereinafter referred to as "cableway installations") are designed, manufactured, put into service and operated with the object of carrying persons. Principally, cableway installations are mountain lift systems used in high-altitude tourist resorts and consisting of funicular railways, cable cars, gondolas, chairlifts and drag lifts, but may also consist of cableway installations used in urban transport facilities. Some types of cableway installation may use other, completely different basic principles which cannot be excluded a priori. Therefore, provision should be made for introducing specific requirements designed to achieve the same safety objectives as those laid down in this Directive.
(2) Cableway installations are principally operated in connection with tourism, particularly in mountain areas, which plays an important role in the economy of the regions concerned and is becoming an increasingly important factor in the trade balances of the Member States. From a technical point of view, the cableway installations sector also ranks among the industrial activities linked to the production of capital equipment and to activities in the building and civil engineering sector.
(3) Member States are responsible for ensuring the safety of cableway installations at the time of manufacture, putting into service and during operation. Moreover, they are responsible together with the competent authorities for such matters as land-use, regional planning and environmental protection. National regulations differ widely as a result of techniques peculiar to the national industry as well as local customs and knowhow. They stipulate specific dimensions and devices and particular characteristics. In the light of these circumstances, manufacturers are obliged to redefine their equipment for each market. This makes it difficult to provide standard solutions and adversely affects competitiveness.
(4) The essential health and safety requirements must be observed in order to ensure that cableway installations are safe. Those requirements are to be applied with discernment to take account of the state of the art at the time of construction and of technical and economic requirements.
(5) Further, cableway installations may straddle frontiers and the construction thereof may run up against conflicting national rules.
(6) Steps should be taken to define, on a Community-wide basis, essential human safety and health requirements, environmental protection and consumer protection requirements applicable to cableway installations, subsystems and their safety components. Without this, mutual recognition of national regulatory provisions would create insoluble political and technical difficulties as regards interpretation and liability. By the same token, standardisation without prior definition of harmonised regulatory requirements is not sufficient to solve the problems.
(7) Responsibility for approving cableway installations is generally vested in a service of the competent national authorities; in certain cases, approval of the components cannot be obtained beforehand but only when the customer applies for such approval. By the same token, the requisite inspection of the cableway installation prior to its entry into service may result in the rejection of certain components or in diverse technological solutions. Such a state of affairs leads to increased costs and longer delivery periods and is particularly penalising for foreign manufacturers. Moreover, cableway installations are also carefully monitored by the public services when they are operational. The causes of serious accidents may be linked to the choice of site, to the system of transport itself, to the structures, or to the way in which the system is operated and maintained.
(8) In these circumstances, the safety of cableway installations depends equally on the surrounding conditions, on the quality of the industrial goods supplied and on the way in which they are assembled, installed on site and monitored during operation. This underlines the importance of having a general overview of cableway installations in order to assess the level of safety and of adopting a common approach at Community level to quality assurance. In these circumstances, in order to enable manufacturers to overcome their present difficulties and in order to enable users to derive the full benefit from cableway installations and to enjoy an equal level of development in all Member States, a set of requirements should be defined, together with control and inspection procedures to be applied uniformly in all Member States.
(9) Persons using cableways, from all Member States and beyond, must be ensured a satisfactory level of safety. In order to meet this requirement, it is necessary to define procedures and examination, control and inspection methods. This necessitates the use of standardised technical devices which must be incorporated in cableway installations.
(10) Where Council Directive 85/337/EEC(4) so requires, the effects of cableway installations on the environment must be assessed; above and beyond the effects mentioned in that Directive, both environmental protection and requirements in connection with the sustainable development of tourism should be taken into account.
(11) Cableway installation may come within the scope of Council Directive 93/38/EEC of 14 June 1993 coordinating the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors(5).
(12) Technical specifications should be included in the general documentation or in the technical specifications peculiar to each contract. Those technical specifications must be defined by reference to European specifications where such specifications exist.
(13) In order to make it easier to prove that the essential requirements have been complied with, it is useful to have harmonised European standards, compliance with which enables it to be presumed that the product is in conformity with the said essential requirements. Harmonised European standards are drawn up by private bodies and must retain their non-mandatory status. For this purpose, the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec) are recognised as the bodies competent to adopt harmonised standards that follow the general guidelines for cooperation between the Commission and those two bodies signed on 13 November 1984.
(14) For the purposes of this Directive, a harmonised standard is a technical specification (European standard or harmonisation document) adopted by one or other of those bodies, or by both, at the request of the Commission pursuant to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services(6) and in accordance with the general guidelines referred to above. In relation to standardisation, the Commission should be assisted by the committee referred to in that Directive, which will, if necessary, consult technical experts.
(15) Only safety components or subsystems of an installation which conform to a national standard transposing a harmonised standard the reference of which has been published in the Official Journal of the European Communities, are deemed to conform to the relevant essential requirements of this Directive, regardless of the need for any special justification.
(16) In the absence of European specifications, the technical specifications should as far as possible be defined by reference to other standards in use in the Community. Main contractors may define the additional specifications needed to supplement the European specifications or other standards. These provisions must ensure that the harmonised Community-level requirements with which cableway installations must comply are satisfied.
(17) It is, moreover, in the interest of the Member States to have an international standardisation system capable of producing standards which are actually used by international trading partners and satisfy the requirements of Community policy.
(18) In certain Member States at the moment in the general documentation or specifications peculiar to each contract, main contractors may indicate the control and inspection procedures. Those procedures must in future, notably in the case of safety components, fall within the framework of the Council resolution of 21 December 1989 concerning a global approach to conformity assessment(7). The concept of safety component applies not only to physical objects but also to intangible objects such as software. The procedures for assessing the conformity of safety components must be based on use of the modules provided for in Council Decision 93/465/EEC(8). In the case of critical safety components, the principles and conditions for the application of design quality assurance should be defined; such an approach is necessary in order to promote the general adoption of the quality assurance system in undertakings.
(19) When conducting methodical safety analysis of cableway installations, it is necessary to identify the components on which the safety of the cableway installation depends.
(20) In their contractual documents, main contractors lay down, by reference to European specifications, the characteristics which manufacturers are under a contractual obligation to observe, particularly for safety components. In these circumstances, the conformity of the components is linked principally to their field of use and not solely to free movement on the Community market.
(21) Safety components should bear the CE marking to be affixed either by the manufacturer or by his authorised representative established within the Community. The CE marking means that the safety component complies with the provisions of this Directive and those of other applicable Community Directives on CE marking.
(22) It is not necessary to affix the CE marking to subsystems subject to the provisions of this Directive but, on the basis of the assessment of conformity following the procedures laid down for this purpose in this Directive, the declaration of conformity will suffice. This is without prejudice to the obligation incumbent on manufacturers to affix the CE marking to certain subsystems in order to certify that they conform with other Community provisions applicable to them.
(23) Member States' responsibility for safety, health and other aspects covered by the essential requirements on their territory must be recognised in a safeguard clause providing for the appropriate Community procedures.
(24) A procedure is necessary for the inspection of subsystems of cableway installations before they are put into service. Such inspection must enable the authorities to satisfy themselves that at each stage of the design, manufacturing and entry into service, the result obtained conforms with the applicable provisions of this Directive. This must enable manufacturers to count on equal treatment, irrespective of the Member State in question. The principles and conditions governing EC verification of subsystems of installations should therefore be defined.
(25) The constraints linked to the operation of cableway installations must be taken into account in the safety analysis, albeit not in such a way as to jeopardise the principle of free movement of goods or the safety of cableway installations. Consequently, although this Directive does not cover the actual operation of cableway installations, the Commission should propose to the Member States a series of recommendations designed to ensure that such installations situated on their territory are operated in such a way as to offer users, operating personnel and third parties a high degree of protection.
(26) In the case of cableway installations, full-scale tests can be carried out on technological innovations only on the construction of a new installation. In these circumstances, a procedure should be provided for which, while ensuring that the essential requirements are complied with, also enables special conditions to be established.
(27) Cableway installations for which authorisation has been given but in connection with which building work has not yet started or which are already under construction must comply with the provisions of this Directive, unless Member States decide otherwise, giving their reasons, and an equally high level of protection is achieved. The provisions of this Directive must be complied with where existing cableway installations are modified if national legislation requires such modifications to be authorised.
(28) It is not necessary to require all existing cableway installations to be brought into conformity with the provisions applicable to new installations. However, this may prove necessary if the essential safety objectives are not complied with. In that event, the Commission should propose to the Member States a series of recommendations designed to ensure that existing cableway installations on their territory afford users a high degree of protection in the light of the provisions applicable in this field to new installations.
(29) Particularly in the absence of a European specification, the notified bodies responsible for procedures for assessing the conformity both of safety components and of subsystems of cable installations must coordinate their decisions as closely as possible. The Commission must ensure that they do so.
(30) Implementation of the essential requirements, particularly with regard to the safety of the installation, and coordination of all procedures call for the establishment of a committee.
(31) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(9),
CHAPTER I
GENERAL PROVISIONS
Article 1
1. This Directive shall apply to cableway installations designed to carry persons.
2. For the purposes of this Directive "cableway installations designed to carry persons" shall mean installations made up of several components, designed, manufactured, assembled and put into service with the object of carrying persons.
These on-site installations are used for the carriage of persons in vehicles or by towing devices, whereby the suspension and/or traction is provided by cables positioned along the line of travel.
3. The installations concerned are:
(a) funicular railways and other installations with vehicles mounted on wheels or on other suspension devices where traction is provided by one or more cables;
(b) cable cars where the cabins are lifted and/or displaced by one or more carrier cables; this category also includes gondolas and chair lifts;
(c) drag lifts, where users with appropriate equipment are dragged by means of a cable.
4. This Directive shall apply to:
- installations built and put into service, as from its entry into force,
- subsystems and safety components placed on the market, as from its entry into force.
It concerns such harmonisation provisions as are necessary and sufficient in order to ensure and guarantee compliance with the essential requirements referred to in Article 3(1).
In the event that important characteristics, subsystems or safety components of existing installations undergo modifications for which a new authorisation for entry into service is required by the Member State in question, such modifications and their repercussions on the installation as a whole must satisfy the essential requirements referred to in Article 3(1).
5. For the purposes of this Directive:
- "installation" shall mean the whole on-site system, consisting of infrastructure and the subsystems listed in Annex I where infrastructure specially designed for each installation and constructed on site shall mean the layout, system data, station structures and structures along the line, which are needed for the construction and the operation of the installation, including the foundations,
- "safety component" shall mean any basic component, set of components, subassembly or complete assembly of equipment and any device incorporated in the installation for the purpose of ensuring a safety function and identified by the safety analysis, the failure of which endangers the safety or health of persons, be they users, operating personnel or third parties,
- "main contractor" shall mean any natural or legal person who commissions the construction of an installation,
- "operability" shall mean all the technical provisions and measures which have an impact on design and realisation and are necessary in order for the installation to operate safely,
- "maintainability" shall mean all the technical provisions and measures which have an impact on design and realisation and are necessary for maintenance designed to ensure that the installation operates safely.
6. This Directive shall not apply to:
- lifts within the meaning of Directive 95/16/EC(10),
- cable-operated tramways of traditional construction,
- installations used for agricultural purposes,
- on-site or mobile equipment for use in fairgrounds and/or amusement parks which are designed for leisure purposes and not as a means for transporting persons,
- mining installations or on-site installations used for industrial purposes,
- cable-operated ferries,
- rack railways,
- chain-driven installations.
Article 2
1. This Directive shall apply without prejudice to other Community Directives, although compliance with the essential requirements laid down in this Directive may call for the application of special European specifications established for that purpose.
2. "European specification" shall mean a common technical specification, a European technical approval or a national standard transposing a European standard.
3. The references of European specifications, which may be common technical specifications, European technical approvals within the meaning of Directive 93/38/EEC or national standards used to transpose harmonised European standards, shall be published in the Official Journal of the European Communities.
4. Member States shall publish the references of national standards used to transpose harmonised European standards.
5. In the absence of harmonised European standards, Member States shall take the necessary measures to inform parties concerned of those existing national standards and technical specifications which are regarded as important or useful for ensuring proper transposition of the essential requirements referred to in Article 3(1).
6. Those technical specifications which are also required to supplement European specifications or other standards must not jeopardise compliance with the essential requirements referred to in Article 3(1).
7. Where a Member State or the Commission considers that a European specification as referred to in paragraph 2 does not entirely satisfy the essential requirements referred to in Article 3(1), the Commission or the Member State concerned shall bring the matter before the committee referred to in Article 17 giving the reasons therefor. The committee shall deliver an opinion without delay.
In the light of the committee's opinion and following consultations with the committee set up pursuant to Directive 98/34/EC in the case of harmonised European standards, the Commission shall inform the Member States whether or not it is necessary to withdraw the European specifications in question from the published information referred to in paragraph 3.
Article 3
1. The installations and their infrastructure, subsystems and safety components of an installation must comply with the essential requirements which are laid down in Annex II and are applicable to them.
2. Where a national standard transposing a harmonised European standard the reference for which has been published in the Official Journal of the European Communities covers the essential safety requirements laid down in Annex II, the installations and their infrastructure, subsystems and safety components of any installation constructed in accordance with the standard shall be presumed to comply with the relevant essential requirements.
Article 4
1. At the request of the main contractor or his authorised representative, all planned installations shall be subject to a safety analysis as defined in Annex III which covers all safety aspects of the system and its surroundings in the context of the design, realisation and putting into service and makes it possible to identify from past experience risks liable to occur during operation.
2. The safety analysis shall be the subject of a safety report recommending the measures envisaged to deal with any such risks and including a list of the safety components and subsystems which must be covered by the provisions of Chapter II or III, as the case may be.
CHAPTER II
SAFETY COMPONENTS
Article 5
1. Member States shall take all necessary measures to ensure that safety components:
- are placed on the market only if they permit the construction of installations complying with the essential requirements referred to in Article 3(1),
- are put into service only if they permit the construction of installations which are not liable to endanger the health or safety of persons or, where applicable, the safety of property when properly installed and maintained and used for their intended purpose.
2. This Directive shall not affect Member States' entitlement to lay down, in compliance with the Treaty, such requirements as they may deem necessary to ensure that persons and in particular workers are protected when using the installations in question, provided that this does not mean that the installations are modified in a way not specified in the Directive.
Article 6
Member States may not, on the basis of this Directive, prohibit, restrict or impede the placing on their national markets of safety components intended to be used in an installation where such components comply with the provisions of this Directive.
Article 7
1. Member States shall regard safety components referred to in Article 4(2) bearing the CE conformity marking shown in Annex IX and accompanied by the EC declaration of conformity provided for in Annex IV as conforming with all the relevant provisions of this Directive.
2. Before a safety component is placed on the market, the manufacturer or his authorised representative established in the Community must:
(a) submit the safety component to a conformity assessment procedure in accordance with Annex V, and
(b) affix the CE conformity marking on the safety component and, on the basis of the modules laid down in Decision 93/465/EEC, draw up an EC declaration of conformity in accordance with Annex IV.
3. The procedure for assessing safety component conformity shall be carried out at the request of the manufacturer or his authorised representative established in the Community by the notified body referred to in Article 16 and appointed by him for this purpose.
4. Where the safety components are subject to other Directives concerning other aspects and which also provide for the affixing of the CE conformity marking, the marking shall indicate that the safety component is also presumed to conform to the provisions of those other Directives.
5. Where neither the manufacturer nor his authorised representative established in the Community has complied with the obligations of paragraphs 1 to 4, those obligations shall devolve on whomsoever places the safety component on the market in the Community. The same obligations shall apply to whomsoever manufactures safety components for his own use.
CHAPTER III
SUBSYSTEMS
Article 8
Member States shall take all necessary measures to ensure that subsystems within the meaning of Annex I are placed on the market only if they permit the construction of installations complying with the essential requirements referred to in Article 3(1).
Article 9
Member States may not, on the basis of this Directive, prohibit, restrict or impede the placing on their national markets for use in an installation, of subsystems which comply with the provisions of this Directive.
Article 10
1. Member States shall regard subsystems within the meaning of Annex I which are accompanied by the EC declaration of conformity based on the model provided for in Annex VI and by the technical documentation provided for in paragraph 3 of this Article, as conforming with the relevant essential requirements referred to in Article 3(1).
2. The EC procedure for examining subsystems shall be carried out at the request of the manufacturer or his authorised representative established in the Community or, in their absence, any natural or legal person who places the subsystem in question on the market, by the notified body referred to in Article 16 which the manufacturer or his authorised representative or the abovementioned person appointed for that purpose. The EC declaration of conformity shall be drawn up by the manufacturer or his authorised representative or the abovementioned person on the basis of the EC examination in accordance with Annex VII.
3. The notified body shall draw up the EC examination certificate in accordance with Annex VII and the technical documentation which accompanies it. The technical documentation must include all the necessary documents concerning the characteristics of the subsystem and, where appropriate, all the documents certifying the conformity of the safety components. It must also contain all the relevant details of the conditions of, and restrictions on, use and of the instructions for servicing.
CHAPTER IV
INSTALLATIONS
Article 11
1. Each Member State shall lay down procedures for authorising the construction and the putting into service of installations which are located within its territory.
2. Member States shall take all appropriate measures and determine the procedures to ensure that safety components and subsystems referred to in Annex I incorporated in installations constructed in their territory are installed and put into service only if they permit the construction of installations which are not liable to endanger the safety and health of persons or, where applicable, the safety of property, when properly installed and maintained and used in accordance with their intended purpose.
3. Where a Member State considers a safety component or subsystem referred to in Annex I to have been designed or constructed using an innovative approach, it shall take all appropriate measures and may make the construction and/or putting into service of an installation in which such innovative components or subsystems are to be used subject to special conditions. It shall immediately inform the Commission thereof, stating its reasons. The Commission shall immediately refer the matter to the committee provided for in Article 17.
4. Member States shall take all appropriate measures to ensure that the installations are constructed and put into service only if they have been designed and constructed in such a way as to guarantee compliance with the essential requirements referred to in Article 3(1).
5. On the basis of the provisions referred to in paragraph 1, Member States may not prohibit, restrict or hinder the free movement of safety components and subsystems referred to in Annex I which are accompanied by an EC declaration of conformity within the meaning of Article 7 or Article 10.
6. The safety analysis, the EC declarations of conformity and the accompanying technical documentation relating to the safety components and subsystems referred to in Annex I must be submitted by the main contractor or his authorised representative to the authority responsible for approving the installation, and a copy of them shall be kept at the installation.
7. Member States must ensure that the safety analysis, the safety report and the technical documentation are provided and include all the documentation concerning the characteristics of the installation and, where appropriate, all the documents certifying the conformity of the safety components and subsystems referred to in Annex I. In addition, documents must exist setting out the necessary conditions, including the restrictions on operation, and full details of servicing supervision, adjustment and maintenance.
Article 12
Without prejudice to other legislative provisions, Member States may not prohibit, restrict or impede the construction and putting into service within their territories of installations which comply with this Directive.
Article 13
Member States shall ensure that an installation remains in operation only if it conforms to the conditions set out in the safety report.
CHAPTER V
SAFEGUARDS
Article 14
1. Where a Member State ascertains that a safety component bearing the CE conformity marking placed on the market and used in accordance with its intended purpose or a subsystem with an EC declaration of conformity as referred to in Article 10(1), used in accordance with its intended, purpose, is liable to endanger the safety and health of persons, and, where applicable, the safety of property, it shall take all appropriate measures to restrict the conditions of use of the component or subsystem or prohibit its use.
The Member State concerned shall immediately inform the Commission of any such measure, indicating the reasons for its decision and whether non-conformity is due, in particular, to:
(a) failure to satisfy the essential requirements referred to in Article 3(1),
(b) incorrect application of the European specifications referred to in Article 2(2) in so far as application of those specifications is invoked,
(c) shortcomings in the European specifications referred to in Article 2(2).
2. The Commission shall enter into consultation with the parties concerned at the earliest opportunity. Where, after such consultation, the Commission finds that:
- the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States; where the decision referred to in paragraph 1 is based on shortcomings in the European specifications, the Commission shall, after consulting the parties concerned, initiate the procedure referred to in Article 2(7) if the Member State which has taken the decision intends to maintain it,
- the measures relating to a safety component are unjustified, it shall immediately so inform the manufacturer or his authorised representative established in the Community and the Member State which took the measures,
- the measures relating to a subsystem are unjustified, it shall immediately so inform the manufacturer or his authorised representative established in the Community or, in their absence, any natural or legal person having placed the subsystem in question on the market, and the Member State which took the measures.
3. Where a safety component bearing the CE conformity marking is found not to comply, the competent Member State shall take appropriate action against whomsoever affixed that marking and drew up the EC declaration of conformity and shall so inform the Commission and the other Member States.
4. Where a subsystem with an EC declaration of conformity is found not to comply, the competent Member State shall take appropriate action against whomsoever drew up the EC declaration of conformity and shall so inform the Commission and the other Member States.
5. The Commission shall ensure that the Member States are kept informed of the outcome of the procedure.
Article 15
If a Member State finds that an approved installation which is used in accordance with its intended purpose is liable to endanger the safety and the health of persons and, where appropriate, the safety of property, it shall take all appropriate measures to restrict the conditions of operation of the installation or to prohibit the operation thereof.
CHAPTER VI
NOTIFIED BODIES
Article 16
1. Member States shall notify the Commission and the other Member States of the bodies responsible for carrying out the conformity assessment procedure referred to in Articles 7 and in Article 10, specifying the field of competence of each body. The Commission shall assign identification numbers to them. The Commission shall publish in the Official Journal of the European Communities the list of notified bodies, together with their identification number and their fields of competence, and shall ensure that the list is kept up to date.
2. Member States must apply the criteria laid down in Annex VIII in assessing the bodies to be notified. Bodies meeting the assessment criteria laid down in the relevant harmonised European standards shall be presumed to fulfil those criteria.
3. A Member State which has notified a body must withdraw its notification if it finds that the body no longer meets the criteria laid down in Annex VIII. It shall immediately inform the Commission and the other Member States thereof.
4. Should the need arise, coordination of the notified bodies shall be implemented in accordance with Article 17.
CHAPTER VII
COMMITTEE
Article 17
1. The Commission shall be assisted by a committee.
2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
3. The committee shall draw up its rules of procedure.
CHAPTER VIII
CE CONFORMITY MARKING
Article 18
1. The CE conformity marking shall consist of the letters "CE". Annex IX sets out the model to be used.
2. The CE conformity marking shall be affixed to each safety component distinctly and visibly or, where that is not possible, on a label inseparably attached to the component.
3. The affixing on safety components of markings which are likely to mislead third parties as to the meaning and form of the CE conformity marking shall be prohibited. Any other marking may be affixed to the safety component, provided that the visibility and legibility of the CE conformity marking are not thereby reduced.
4. Without prejudice to Article 14:
(a) where a Member State establishes that the CE conformity marking has been wrongly affixed, the manufacturer of the safety component or the authorised representative of the latter established in the Community shall be obliged to make the product conform as regards the provisions concerning the CE conformity marking and to end the infringement under the conditions imposed by the Member State;
(b) should non-conformity persist, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the safety component in question, or to ensure that it is withdrawn from the market in accordance with the procedures provided for in Article 14.
CHAPTER IX
FINAL PROVISIONS
Article 19
Any decision taken pursuant to this Directive which restricts the use of safety components or of a subsystem in an installation or the placing on the market thereof shall state the grounds on which it is based. Such a decision shall be notified at the earliest opportunity to the party concerned, who shall at the same time be informed of the legal remedies available to him under the law in force in the Member States concerned and of the time limits to which such remedies are subject.
Article 20
Installations for which authorisation has been given before the entry into force of this Directive and for which construction has not yet started must comply with the provisions of this Directive, unless Member States decide otherwise, stating their reasons, and an equally high level of protection is achieved.
Article 21
1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 3 May 2002. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.
3. Member States shall, for a period of four years following entry into force of this Directive, allow:
- the construction and putting into service of installations,
- the placing on the market of subsystems and safety components
which conform with the provisions in force in their territories on the date of entry into force of this Directive.
4. The Commission shall report to the European Parliament and the Council on the implementation of this Directive, and in particular Article 1(6) and 17 thereof, not later than 3 May 2004 and, if necessary, submit any proposal for appropriate amendments.
Article 22
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 23
This Directive is addressed to the Member States.
|
[
"UKSI20040129"
] |
32000L0007
|
2000
|
Directive 2000/7/EC of the European Parliament and of the Council of 20 March 2000 on speedometers for two- or three-wheel motor vehicles and amending Council Directive 92/61/EEC on the type-approval of two- or three-wheel motor vehicles
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),
Whereas:
(1) Road safety is a fundamental Community objective which requires speed to be monitored and checked by means of a speedometer, with a view to raising awareness, particularly among young people, of the need for proper road use.
(2) The technical legislation on road safety should be adopted in a cohesive fashion, in the form of "packages" of directives, so as to raise public awareness of the European Union's contribution to enhancing road safety.
(3) In every Member State, two- or three-wheel motor vehicles must, as regards speedometers, display certain technical characteristics laid down as compulsory requirements that vary from Member State to Member State; such variation constitutes an obstacle to intra-Community trade.
(4) Such obstacles to the functioning of the internal market can be eliminated by the adoption of the same requirements by all the Member States in lieu of their existing rules and regulations.
(5) This Directive is to be added to the separate Directives that must be complied with under Article 4 of Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two- or three-wheel motor vehicles(4).
(6) The introduction of harmonised requirements for speedometers in two- or three-wheel motor vehicles is necessary in order to permit implementation, for each type of those vehicles, of the type-approval and approval procedures laid down by Directive 92/61/EEC.
(7) In accordance with the principles of subsidiarity and proportionality as set out in Article 5 of the Treaty, the objective of the action envisaged, namely Community type-approval by type of vehicle, cannot be sufficiently achieved by the Member States and can therefore, in view of the scale and the impact of the action proposed, be better achieved at the Community level. This Directive limits itself to the minimum required for the attainment of that objective and does not go beyond what is necessary for that purpose.
(8) To facilitate access to the markets of non-member countries, it is clearly necessary to establish equivalence between the requirements of this Directive and those of Regulation No 39 of the Economic Commission for Europe of the United Nations (hereinafter referred to as "UN-ECE Regulation No 39").
(9) The Member States of the European Union must negotiate as soon as possible an amendment to UN-ECE Regulation No 39 to align it with the provisions of this Directive.
(10) Directive 92/61/EEC should therefore be amended accordingly,
Article 1
1. This Directive shall apply to the speedometer of each type of vehicles described in Article 1 of Directive 92/61/EEC.
2. Any vehicle falling within the scope of Directive 92/61/EEC shall be fitted with a speedometer complying with the Annex to this Directive.
Article 2
The procedures for the granting of component type-approval in respect of the speedometer of a type of two- or three-wheel motor vehicle and the conditions governing the free movement of such vehicles shall be as laid down in, respectively, Chapters II and III of Directive 92/61/EEC.
Article 3
In accordance with Article 11 of Directive 92/61/EEC, the equivalence between the requirements laid down in this Directive and those laid down in UN-ECE Regulation No 39, in the latest version adopted by the Community, is hereby acknowledged.
The authorities of the Member States which grant type-approval shall accept approvals, and type-approval marks, granted in accordance with the requirements of the said Regulation No 39 within the scope of that Regulation, in place of the corresponding approvals and type-approval marks granted in accordance with the requirements of this Directive.
Article 4
The amendments that are essential in order to take account of the amendments to UN-ECE Regulation No 39 and to adapt the Annex to technical progress shall be adopted in accordance with the procedure referred to in Article 13 of Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers(5).
Article 5
Directive 92/61/EEC is amended as follows:
1. In Annex I, heading No 45, "Speedometer and odometer for motorcycles, motor tricycles and quadricycles" shall be replaced by "Speedometer" and the term "CONF" by "SD".
2. Annex IIA is amended as follows:
(a) item 4.7. "Speedometer and odometer: yes/no (1)" shall be replaced by "Speedometer";
(b) the following items shall be inserted:
"4.7.3. Photos and/or drawings of the complete system
4.7.4. Range of speeds displayed
4.7.5. Tolerance of the speedometer's measuring mechanism
4.7.6. Technical constant of the speedometer
4.7.7. Modus operandi and description of the drive mechanism
4.7.8. Overall transmission ratio of the drive mechanism".
3. In Annex IIIB, heading No 10.12, "Speedometer and odometer for motorcycles, motor tricycles and quadricycles" shall be replaced by "Speedometer" and the term "CONF" by "SD".
Article 6
1. Member States shall bring into force the laws, regulations and administrative provisions needed in order to comply with this Directive before 1 January 2001. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
2. The Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the area covered by this Directive.
3. With effect from 1 January 2001, Member States may no longer prohibit, on grounds relating to the speedometers, the first bringing into service of vehicles that meet the requirements of this Directive.
4. Member States shall apply the requirements set out in the first subparagraph of paragraph 1 as from 1 July 2001, except for mopeds, to which these requirements shall be applicable from 1 July 2002.
Article 7
This Directive shall take effect on the day of its publication in the Official Journal of the European Communities.
Article 8
This Directive is addressed to the Member States.
|
[
"UKSI20010368"
] |
32000L0008
|
2000
|
Directive 2000/8/EC of the European Parliament and of the Council of 20 March 2000 amending Council Directive 70/221/EEC on the approximation of the laws of the Member States relating to liquid fuel tanks and rear underrun protection of motor vehicles and their trailers
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),
Whereas:
(1) Council Directive 70/221/EEC of 20 March 1970 on the approximation of the laws of the Member States relating to liquid fuel tanks and rear underrun protection for motor vehicles and their trailers(4), is one of the separate directives within the EC type-approval procedure which was established by Council Directive 70/156/EEC of 6 February 1990 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers(5); consequently, the provisions and definitions laid down in Directive 70/156/EEC concerning vehicles, vehicles systems, components and separate technical units apply to Directive 70/221/EEC; it is necessary to adapt Article 1 of Directive 70/221/EEC to the definitions of Directive 70/156/EEC.
(2) In order to take account of technical progress, it is advisable to adapt Directive 70/221/EEC to the technical requirements adopted by the United Nations Economic Commission for Europe in its Regulation No 34 relating to the approval of vehicles with regard to the prevention of fire risk, in particular, to the provisions of fuel tanks made of plastic material.
(3) The accidental spillage of fuel (especially diesel) on to the road is a significant hazard for riders of two-wheeled motor vehicles and pedal cycles.
(4) There is increasing interest in gaseous fuels for the propulsion of motor vehicles, in particular for environmental reasons; whereas therefore, in future, Directive 70/221/EEC should also contain provisions for tanks for fuels other than liquid fuels; for this purpose the title and the scope of Directive 70/221/EEC should be amended accordingly; technical specifications for tanks for gaseous fuels will be introduced through later amendments of the said Directive.
(5) Furthermore, it is more and more common for original fuel tanks to be replaced by larger fuel tanks or for additional, unapproved fuel tanks to be installed; provision should consequently be made at the earliest opportunity for Community type-approval of liquid and gas fuel tanks as separate technical units, in order to maintain a high level of safety in motor-vehicle traffic.
(6) Amendments to the provisions relating to fuel tanks have to be adopted by the European Parliament and the Council; whereas it is expedient that, in the future, amendments necessary for adjusting the technical requirements of Directive 70/221/EEC relating to fuel tanks to technical progress should be adopted in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC.
(7) The amendments made by this Directive relate in particular to fuel tanks made of a plastic material; it is unnecessary therefore to invalidate existing approvals granted under Directive 74/60/EEC(6) and to prevent the sale, registration and entry into service of new vehicles having metal liquid fuel tanks covered by such approvals.
(8) Given the scale and impact of the action proposed in the sector in question, the Community measures which are the subject of this Directive are necessary, or even indispensable, to attain the objective set, namely Community vehicle type-approval; this objective cannot be adequately achieved by the Member States individually,
Article 1
Directive 70/221/EEC is hereby amended as follows:
1. The title shall be replaced by the following:
"Council Directive of 20 March 1970 on the approximation of the laws of the Member States relating to fuel tanks and rear underrun protection of motor vehicles and their trailers".
2. Article 1 shall be replaced by the following:
"Article 1
For the purpose of this Directive, 'vehicle' means any motor vehicle and its trailers as defined in Annex II Section A to Directive 70/156/EEC."
3. Article 2(1) shall be replaced by the following:
"1. No Member State may refuse to grant EC type-approval or national type-approval for a vehicle on grounds relating to its fuel tanks if such vehicle satisfies the requirements set out in this Directive concerning fuel tanks."
4. Article 2a(1) shall be replaced by the following:
"1. No Member State may refuse or prohibit the sale, registration, entry into service or use of a vehicle on grounds relating to its fuel tanks if such a vehicle satisfies the requirements set out in this Directive concerning fuel tanks."
5. Article 3 shall be replaced by the following:
"Article 3
Any amendments necessary to adapt the requirements of the Annexes to technical progress, shall be adopted in accordance with the procedure laid down in Article 13 of Directive 70/156/EEC."
6. The list of Annexes and Annex I to Directive 70/221/EEC are hereby amended in accordance with the Annex to this Directive.
Article 2
1. With effect from 3 May 2001, Member States shall accept compliance with the requirements of Directive 70/221/EEC, as amended by this Directive, for the purposes of Articles 4(1) and 7(1) of Directive 70/156/EEC.
2. With effect from 3 May 2002, Member States:
- shall no longer grant EC type-approval in accordance with Article 4(1) of Directive 70/156/EEC, and
- may refuse national type-approval,
for a new type of vehicle on grounds related to its fuel tanks if it fails to comply with the provisions of Directive 70/221/EEC, as amended by this Directive.
3. With effect from 3 May 2003, Member States
- shall consider certificates of conformity which accompany new vehicles in accordance with the provisions of Directive 70/156/EEC as no longer valid for the purposes of Article 7(1) of that Directive, and
- may refuse the sale, registration or entry into service of new vehicles which are not accompanied by a certificate of conformity valid in accordance with Directive 70/156/EEC, except where the provisions of Article 8(2) of that Directive are invoked,
on grounds relating to the fuel tanks, if the requirements of Directive 70/221/EEC, as amended by this Directive, are not fulfilled.
4. This Directive shall not invalidate any approval previously granted to vehicles having metal liquid fuel tanks nor prevent extensions of such approvals under the terms of the directive under which they were originally granted.
Article 3
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 3 May 2001 and shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive.
Article 4
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 5
This Directive is addressed to the Member States.
|
[
"UKSI20012809",
"UKSI20002730"
] |
32000L0016
|
2000
|
Directive 2000/16/EC of the European Parliament and the Council of 10 April 2000 amending Council Directive 79/373/EEC on the marketing of compound feedingstuffs and Council Directive 96/25/EC on the circulation of feed materials
Having regard to the Treaty establishing the European Community, and in particular Article 152(4) thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
After consulting the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),
Whereas:
(1) Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector and amending Directives 70/524/EEC, 74/63/EEC, 79/373/EEC and 82/471/EEC(4) lays down the principle of allocating an approval number to certain establishments or intermediaries; for reasons of transparency and in order to facilitate checks, the registration number or approval number, as the case may be, should be required to be shown on the label or in the document accompanying the compound feedingstuffs.
(2) Article 2(l) of Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs(5) defines the minimum storage life of a compound feedingstuff as lasting until that date until which, under proper storage conditions, that feedingstuff retains its specific properties; the term "specific properties" encompasses all the properties which determine the quality of a compound feedingstuff, particularly the effectiveness of the additives it contains; this effectiveness is indicated by the expiry date of the guarantee, which has to be stated in accordance with Council Directive 70/524/EEC(6); therefore, in all cases in which the minimum storage life of an additive is the limiting factor as regards the quality of a compound feedingstuff, this date is decisive in determining the minimum storage life of the compound feedingstuff; however, the relevant provision in Article 5d(1), second subparagraph, of Directive 79/373/EEC does not provide sufficient clarity and should therefore be replaced.
(3) The German version of Directive 79/373/EEC uses the term "circulation" (Verkehr) instead of "marketing" (Vermarktung), as in the other language versions; since there is a difference in meaning, the language versions need to be aligned; since the scope of more recent Directives on animal feed law usually extends to "putting into circulation" or "circulation", Directive 79/373/EEC should be adjusted accordingly and a definition of "circulation" ("putting into circulation") should be included.
(4) In accordance with Directive 79/373/EEC, Commission Decision 91/516/EEC(7) establishes a list of ingredients whose use is prohibited in compound feedingstuffs for reasons related to the protection of human and animal health; this ban does not, however, cover the circulation of such materials as feed materials or the use of these materials as such as feed materials by livestock farmers.
(5) In order to remedy this situation, it is necessary, firstly, to widen the scope of Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC(8), in order to cover the use of feed materials as well; secondly, a list of materials whose circulation or use as feed materials is prohibited or restricted should be drawn up to replace Commission Decision 91/516/EEC, so that the scope of the prohibitions or restrictions is general and applies both to the use of the feed materials as such as well as to their use in compound feedingstuffs; Council Directive 79/373/EEC should be amended accordingly.
(6) Experience has shown also that certain by-products which have been subjected to industrial processes may contain substances which, although not representing a threat to animal or human health, may have an unfavourable impact on the environment; it is therefore necessary to provide also that feed materials must not represent any danger to the environment.
(7) Council Directive 90/667/EEC of 27 November 1990 laying down the veterinary rules for the disposal and processing of animal waste, for its placing on the market and for the prevention of pathogens in feedstuffs of animal or fish origin, and amending Directive 90/425/EEC(9), lays down the rules for the placing on the market of animal waste intended for uses other than human consumption, and Directive 96/25/EC lays down rules applying to labelling providing users with accurate information concerning the identity of the products and any restrictions on their use; there is a need to ensure that instruments relating to the veterinary sector and to animal nutrition are in perfect concordance.
(8) In order to provide users and control authorities with the means to verify without difficulty the origin of feed materials and their compliance with the health guarantees with regard to Directive 90/667/EEC, it is necessary to include among the indications required for those feed materials the name and address of the producing establishment, the approval number, the reference number of the batch or any other particulars that will ensure that the feed material can be traced.
(9) Directives 79/373/EEC and 96/25/EC should be amended accordingly,
Article 1
Directive 79/373/EEC is hereby amended as follows:
1. in Article 2, the following subparagraph shall be added:
"(m) 'putting into circulation' or 'circulation': the holding of compound feedingstuffs for the purposes of sale, including offering for sale, or any other form of transfer, whether free or not, to third parties, and the sale and other forms of transfer themselves.";
2. in Article 5(1), point (k) shall be replaced by the following:
"(k) from 1 April 2001, the approval number allocated to the establishment in accordance with Article 5 of Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector(10) or, as the case may be, the registration number allocated to the establishment in accordance with Article 10 of that Directive.";
3. in Article 5d(1), the second subparagraph shall be replaced by the following:"Where other Community provisions concerning compound feedingstuffs require indication of a minimum storage life or an expiry date of guarantee, the indication referred to in the first subparagraph shall be made, giving only the earliest date.";
4. in Article 10, point (c) shall be deleted;
5. in Article 10(e), the words "and the lists referred to in points (b) and (c)" shall be deleted;
6. in Article 10a, the following paragraph shall be added:
"3. Member States shall prescribe that the feed materials appearing on the list provided for in Article 11(b) of Directive 96/25/EC may not be used as feed materials in the preparation of compound feedingstuffs, in accordance with the provisions laid down in that Directive.";
7. throughout the Directive, the term "marketing" shall be replaced by "circulation";
8. (does not concern the English version).
Article 2
Directive 96/25/EC is hereby amended as follows:
1. the title shall be replaced by the following:
"Council Directive 96/25/EC of 29 April 1996 on the circulation and use of feed materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC";
2. Article 1(1) shall be replaced by the following:
"1. This Directive shall apply to the circulation and use of feed materials within the Community.";
3. Article 3 shall be replaced by the following:
"Article 3
Without prejudice to the obligations arising under other Community provisions, Member States shall prescribe that feed materials may be put into circulation in the Community only if they are of sound, genuine and merchantable quality. They shall prescribe that, when put into circulation or used, feed materials must not represent any danger to animal or human health or to the environment and must not be put into circulation in a manner that is liable to mislead.";
4. In Article 5(1), point (g) shall be replaced by the following:
"(g) the name or business name and the address or registered place of business of the producing establishment, the approval number, the reference number of the batch or any other particulars which ensure that the feed material can be traced, where the establishment must be approved in accordance with:
- Directive 90/667/EEC(11),
- Community measures included on a list to be drawn up in accordance with the procedure set out in Article 13;
(h) the name or business name and the address or registered place of business of the person responsible for the particulars referred to in this paragraph, if different from the producer referred to in point (g).";
5. Article 11 shall be amended as follows:
(a) the words "Article 14" shall be replaced by "Article 13";
(b) point (b) shall be replaced by the following:
"(b) a list of materials whose circulation or use for animal nutrition purposes is restricted or prohibited shall be drawn up in order to ensure their compliance with Article 3;
(c) amendments to the list referred to in point (b) shall be adopted in the light of advances in scientific and technical knowledge;
(d) amendments to the Annex shall be adopted in the light of advances in scientific and technical knowledge."
Article 3
1. Member States shall adopt and publish not later than 3 May 2001, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall inform the Commission thereof forthwith. The provisions adopted shall at the latest apply from 3 November 2001.
When the Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.
Article 4
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 5
This Directive is addressed to the Member States.
|
[
"UKSI20013389"
] |
32000L0019
|
2000
|
Commission Directive 2000/19/EC of 13 April 2000 adapting to technical progress Council Directive 86/298/EEC on rear-mounted roll-over protection structures of narrow-track wheeled agricultural and forestry tractors (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors(1), as last amended by Commission Directive 2000/2/EC(2), and in particular Article 11 thereof,
Having regard to Council Directive 86/298/EEC of 26 May 1986 on rear-mounted roll-over protection structures of narrow-track wheeled agricultural and forestry tractors(3), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 12 thereof,
Whereas:
(1) In order to improve safety, it is necessary to clarify the methods for testing rear-mounted roll-over protection structures of narrow-track wheeled agricultural and forestry tractors taking account of the wide range of equipment.
(2) The methods for testing these structures should be harmonised with those laid down in Code 7 of the Organisation for Economic Cooperation and Development (OECD) on official tests of protection structures for agricultural tractors.
(3) Directive 86/298/EEC should be amended accordingly.
(4) The measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Article 12 of Directive 74/150/EEC,
Article 1
Annexes I to VI to Directive 86/298/EEC are hereby amended in accordance with the Annex to this Directive.
Article 2
1. From 1 July 2001, Member States may not:
- refuse, for a type of tractor, to grant EC type-approval or issue the document provided for in the third indent of Article 10(1) of Directive 74/150/EEC, or to grant national type-approval, or
- prohibit the first entry into service of tractors,
if those tractors comply with the requirements of Directive 86/298/EEC, as amended by this Directive.
2. From 1 January 2002, Member States:
- may no longer issue the document provided for in the third indent of Article 10(1) of Directive 74/150/EEC for as type of tractor if it does not comply with the requirements of Directive 86/298/EEC, as amended by this Directive,
- may refuse to grant national type-approval for a type of tractor if it does not comply with the requirements of Directive 86/298/EEC, as amended by this Directive.
Article 3
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 2001 at the latest. They shall forthwith inform the Commission thereof.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such as reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the main provisions of national law that they adopt in the field covered by this Directive.
Article 4
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 5
This Directive is addressed to the Member States.
|
[
"UKSI20011710"
] |
32000L0018
|
2000
|
Directive 2000/18/EC of the European Parliament and of the Council of 17 April 2000 on minimum examination requirements for safety advisers for the transport of dangerous goods by road, rail or inland waterway
Having regard to the Treaty establishing the European Community, and in particular Article 75(1)(c) thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
After consulting the Committee of the Regions,
Acting in accordance with the procedure referred to in Article 251 of the Treaty(3),
(1) Whereas the improvement of transport safety and the protection of the environment, especially within the context of the transport of dangerous goods by road, rail and inland waterway, are important issues, as is also the human element in the safe operation of these modes of transport.
(2) Whereas under the terms of Council Directive 96/35/EC of 3 June 1996 on the appointment and vocational qualification of safety advisers for the transport of dangerous goods by road, rail and inland waterway(4), all undertakings the activities of which include the transport of dangerous goods, as well as the loading or unloading related to that type of transport, are obliged to appoint one or more safety advisers. The said Directive does not contain any detailed provisions aimed at the harmonisation of examination requirements for safety advisers or any provisions applicable to examination bodies.
(3) Whereas Member States should set up a common minimum framework for the examination of safety advisers and the conditions for the examination bodies in order to guarantee a certain level of quality and to facilitate the mutual recognition of EC certificates of training.
(4) Whereas the examination of safety advisers will as a minimum include a written test consisting of questions relating at least to the subjects listed in Annex II to Directive 96/35/EC and a case study whereby the candidates can demonstrate that they have the ability to carry out the tasks of a safety adviser.
(5) Whereas Member States may provide that candidates who intend to work for undertakings whose activities are concerned only with specific dangerous goods will be examined only on subject matters related to their activities. In this case, the EC certificate of training should clearly indicate the limits of its validity.
(6) Whereas the examination organised by the examination bodies will be subject to approval of the Member States' competent authorities. Member States will define the criteria applicable to examination bodies should be technically competent, reliable and independent.
(7) Whereas Member States should assist one another in the implementation of this Directive,
CHAPTER I
Scope and definitions
Article 1
1. This Directive lays down the minimum examination requirements for the examination needed to obtain the EC certificate of training as safety adviser for the transport of dangerous goods provided for in Directive 96/35/EC.
2. Member States shall take all necessary measures to ensure that safety advisers for the transport of dangerous goods are examined in such a way that they satisfy these minimum requirements.
Article 2
For the purposes of this Directive:
(a) "safety adviser for the transport of dangerous goods", hereinafter referred to as "adviser", shall mean any person specified in Article 2(b) of Directive 96/35/EC;
(b) "dangerous goods" shall mean goods defined in Article 2 of Directive 94/55/EC(5) and Article 2 of Directive 96/49/EC(6);
(c) "undertaking" shall mean the undertakings specified in Article 2(a) of Directive 96/35/EC;
(d) "examination" shall mean the examination specified in Article 5(2) of Directive 96/35/EC;
(e) "examination body" shall mean any body designated by the competent authorities of the Member States to hold examinations;
(f) "EC certificate" shall mean the certificate established in accordance with the model given in Annex III to Directive 96/35/EC.
CHAPTER II
Examinations
Article 3
1. The competent authority or examining body shall organise a compulsory written examination which it may supplement with an oral examination to check whether candidates possess the necessary level of knowledge required to carry out the tasks of adviser in order to obtain the EC certificate.
2. The compulsory examination shall consist of a written test adapted to the mode(s) of transport in respect of which the EC certificate is issued.
3. (a) The candidate shall be given a questionnaire. It shall consist of at least 20 open questions relating, in accordance with Article 5(4) of Directive 96/35/EC, at least to the subjects listed in Annex II to the said Directive. However, use may be made of multiple choice questions. In that case, two multiple choice questions shall be equal to one open question.
Among those subjects, particular attention, appropriate to the mode of transport concerned, shall be given to the following topics:
- general prevention and safety measures,
- the classification of dangerous goods,
- general packaging requirements, including tanks, tank containers and rail tankers,
- danger markings and labels,
- references in transport documents,
- handling and stowage,
- the vocational training of crews,
- vehicle papers and transport certificates,
- safety instructions,
- transport equipment requirements.
(b) Candidates shall carry out a case study in connection with Annex I to Directive 96/35/EC whereby they can demonstrate that they have the ability to carry out the tasks of adviser.
(c) Member States may provide that candidates who intend to work for undertakings specialised in the transport of certain types of dangerous goods shall be tested, in accordance with Annex II of Directive 96/35/EC, only on matters related to their activities.
These types of goods shall be:
- class 1 (explosives),
- class 2 (gases),
- class 7 (radioactive material),
- classes 3, 4.1, 4.2, 4.3, 5.1, 5.2, 6.1, 6.2, 8 and 9 (solids and liquids),
- UN numbers 1202, 1203, 1223 (mineral oils).
The heading of the EC certificate must clearly indicate that it is valid only for types of dangerous goods referred to in this paragraph and on which the adviser has been examined in accordance with the requirements defined in (a) and (b).
4. The competent authority or examination body shall gradually establish a compendium of the questions which have been included in the examination.
CHAPTER III
Criteria applicable to examination bodies
Article 4
1. If Member States do not take direct charge of the organisation of the examination, they shall appoint the examination bodies on the basis of the following criteria:
(a) competence of the examination body;
(b) specification of the examination arrangements proposed by the examination body;
(c) measures intended to ensure the impartiality of the examinations;
(d) independence of the body as regards any natural or legal persons employing advisers.
2. The approved examination body shall be designated in writing. Such approval may be of limited duration.
Article 5
Member States shall assist one another in implementing this Directive.
Each Member State shall submit on a regular basis to the Commission the compendium of questions referred to in Article 3(4). The Commission shall inform the other Member States thereof.
CHAPTER IV
Final provisions
Article 6
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within three months of its entry into force. They shall forthwith inform the Commission thereof.
When the Member States adopt these measures, they shall include a reference to this Directive or shall be accompanied by such a reference upon their official publication. The Member States shall lay down the manner in which such references shall be made.
2. The Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.
Article 7
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 8
This Directive is addressed to the Member States.
|
[
"UKSI19990257"
] |
32000L0023
|
2000
|
Commission Directive 2000/23/EC of 27 April 2000 amending Directive 92/76/EEC recognising protected zones exposed to particular plant health risks in the Community
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(1), as last amended by Commission Directive 1999/53/EC(2) and in particular the first subparagraph of Article 2(1)(h) thereof,
Having regard to Commission Directive 92/76/EEC of 6 October 1992 recognising protected zones exposed to particular plant health risks in the Community(3), as last amended by Commission Directive 1999/84/EC(4) and in particular Article 2 thereof,
Whereas:
(1) Under Directive 92/76/EEC, as amended, Austria, Ireland and the regions of Apulia, Emilia-Romagna, Lombardia and Veneto in Italy were provisionally recognised as "protected zone" in respect of Erwinia amylovora for a period expiring on 31 March 2000.
(2) From information supplied by Austria, Ireland and Italy and from the information gathered by the Food and Veterinary Office during missions carried out in 1999 it appears that the provisional recognition of the protected zones for Austria, Ireland and Italy in respect of Erwinia amylovora should be extended exceptionally for a further limited period to enable the responsible official bodies of these countries to complete the information on the distribution of Erwinia amylovora and to complete their efforts for the eradication of this harmful organism in the relevant areas in the above countries.
(3) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,
Article 1
The date of "31 March 2000" referred to in the first subparagraph of Article 1 of Directive 92/76/EEC is hereby replaced by "31 March 2001".
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The procedure for such a reference shall be adopted by Member States.
2. Member States shall immediately communicate to the Commission the essential provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof.
Article 3
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities. It shall apply from 31 March 2000.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI19931320"
] |
32000L0024
|
2000
|
Commission Directive 2000/24/EC of 28 April 2000 amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables(1), as last amended by Directive 97/41/EC(2), and in particular Article 5 thereof,
Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(3), as last amended by Commission Directive 1999/71/EC(4), and in particular Article 10 thereof,
Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin(5), as last amended by Directive 1999/71/EC, and in particular Article 10 thereof,
Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on products of plant origin, including fruit and vegetables(6), as last amended by Directive 1999/71/EC, and in particular Article 7 thereof,
Whereas:
(1) For cereals and products of plant origin, including fruit and vegetables, maximum residue levels reflect the use of minimum quantities of pesticides to achieve effective protection of plants, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable, in particular in view of the protection of the environment and in terms of estimated dietary intake. For foodstuffs of animal origin, maximum residue levels reflect the consumption of cereals and products of plant origin treated with pesticides resulting in residues in animals and animal products, as well as taking into account the direct consequences of the use of veterinary medicines where appropriate.
(2) Maximum residue levels are fixed at the lower limit of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residue in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported with such necessary data.
(3) Maximum residue levels for pesticides should be kept under review. The levels may be changed to take account of new information and data.
(4) Aramite, barban, chlorobenzilate, chlorfenson, chloroxuron, chlorbenside, 1,1-dichloro-2,2-bis (4-ethyl-phenyl-) ethane and diallate are either no longer authorised for use in the Community or are no longer used at Community level. The aramite and chlorfenson residues were deleted from Annex II to Directive 76/895/EEC by Council Directive 82/528/EEC(7) but have not since that time been added to the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC. The chlorbenside and 1,1-dichloro-2,2-bis (4-ethyl-phenyl-) ethane residues were deleted from Annex II to Directive 76/895/EEC by Council Directive 93/58/EEC(8) but have not since that time been added to the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC. It is necessary to add all of these residues to the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC to allow for proper surveillance and control of their uses and to protect the consumer.
(5) Limited authorisations still exist in the Community for chlorbufam and methoxychlor. The authorised uses would not be expected to give rise to detectable residues in food. Maximum residue levels have been fixed in Annex II to Directive 76/895/EEC for these residues.
(6) To establish maximum levels of pesticide residues for barban, chlorbufam, chlorobenzilate, chloroxuron, diallate and methoxychlor at Community level it is necessary to transfer provisions from Directive 76/895/EEC to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC. Certain of these provisions should be amended in the light of technical and scientific progress as well as changes in uses and authorisations at national and Community level.
(7) Community maximum residue levels and levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures. With the exception of chlorobenzilate, no Codex maximum residue limits were set for the active substances covered by this Directive. The Codex maximum residue limits for chlorobenzilate have been withdrawn(9). Authorisations of plant protection products in third countries may require the use of greater quantities of pesticides or shorter pre-harvest intervals than are authorised in the Community and consequently may require higher residue levels. The Community's trading partners have been consulted about the levels set out in this Directive through the World Trade Organisation and their comments on these levels have been considered and discussed by the Standing Committee on Plant Health. The possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the European Community on the basis of the submission of acceptable data.
(8) The maximum residue levels established in this Directive may have to be reviewed in the framework of the re-evaluation of active substances provided for in the programme of work established in Article 8(2) of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(10), as last amended by Commission Directive 1999/80/EC(11).
(9) The maximum residue level for cartap in tea was set at 20 mg/kg in Community legislation on the basis of the information contained in the Codex Alimentarius. The 29th meeting of the Codex Committee on Pesticide Residues recommended that all MRLs for the active substance be withdrawn(12).
(10) A lack of clarity in the description of CN codes in Annexes I and II to Directive 86/363/EEC has led to problems in classifying samples for the purposes of the notification procedure under Article 7 of Directive 86/363/EEC.
(11) DDT is not authorised for use as a plant protection product in the Community. A maximum residue level for DDT in birds' eggs and egg yolks of 0,1 mg/kg was set in Community legislation by Council Directive 93/57/EEC(13) to allow for the possibility that residual environmental contamination may give rise to DDT residues in eggs. Monitoring data for DDT in eggs in Community Member States and in Norway indicate that this maximum level may be reduced.
(12) This Directive is in accordance with the opinion of the Standing Committee on Plant Health,
Article 1
Annex II to Directive 76/895/EEC is hereby amended as follows:
1. The entries relating to chlorobenzilate, chloroxuron and methoxychlor shall be deleted.
2. The grouping "barban, chlorpropham, chlorbufam" shall be replaced by "chlorpropham".
3. The grouping "diallate, triallate" shall be replaced by "triallate".
Article 2
Directive 86/362/EEC is hereby amended as follows:
The following pesticide residues shall be added to Part A of Annex II:
>TABLE>
Article 3
Directive 86/363/EEC is hereby amended as follows:
1. The following pesticide residues shall be added to part A of Annex II:
>TABLE>
2. The following pesticide residues shall be added to part B of Annex II:
>TABLE>
3. In Annex I, the text in the column "Description" which corresponds to CN code ex 0208 shall be replaced by the text "Other meat and edible meat offal of domestic pigeons, domestic rabbits and game, fresh, chilled or frozen".
4. In Annex II, in the tables in Parts A and B, in the column "meat", the text "ex 0201" shall be replaced by the text ">TABLE>
0201".
5. In Annex II, in the table in Part A, in the column relating to birds' eggs and egg yolks, the value of 0,1 mg/kg for DDT shall be replaced by the value 0,05 mg/kg.
Article 4
Directive 90/642/EEC is hereby amended as follows:
1. The following pesticide residues shall be added to Annex II:
>TABLE>
2. In the German text, in Annexes I and II, in the group "2.5(a) Salat u. ä.", the term "Kopfsalat" shall be replaced by the term "Salat".
3. In the Dutch text, in Annexes I and II, in the group "2.5(a) Sla en dergelijke", the term "Kropsla/ijsbergsla" shall be replaced by the term "Sla".
4. In Annex II, the maximum residue level for cartap in tea (dried leaves and stalks, fermented or otherwise, Camellia sinensis) shall be fixed at 0,1 (*) mg/kg (where (*) indicates that this level is at the lower limit of analytical determination).
Article 5
1. This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
2. Member States shall adopt and publish the legislative, regulatory or administrative measures to comply with this Directive by 31 December 2000. They shall immediately inform thereof the Commission.
3. They shall apply these measures as from 1 January 2001.
4. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. Member States shall adopt the procedure for such reference.
Article 6
This Directive is addressed to the Member States.
|
[
"UKSI20011113"
] |
32000L0022
|
2000
|
Commission Directive 2000/22/EC of 28 April 2000 adapting to technical progress Council Directive 87/402/EEC on roll-over protection structures mounted in front of the driver's seat on narrow-track wheeled agricultural and forestry tractors (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors(1), as last amended by Commission Directive 2000/2/EC(2), and in particular Article 11 thereof,
Having regard to Council Directive 87/402/EEC of 25 June 1987 on roll-over protection structures mounted in front of the driver's seat on narrow-track wheeled agricultural and forestry tractors(3), as last amended by the Act of Accession of Austria, Finland and Sweden, and in particular Article 11 thereof,
Whereas:
(1) In order to improve safety, it is necessary to clarify the methods for testing protection structures mounted in front of the driver's seat on narrow-track wheeled agricultural and forestry tractors taking account of the wide range of equipment.
(2) The methods for testing these structures should be harmonised with those laid down in Code 6 of the Organisation for Economic Cooperation and Development (OECD) on official tests of protection structures for agricultural tractors.
(3) Directive 87/402/EEC should be amended accordingly.
(4) The measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress established by Article 12 of Directive 74/150/EEC,
Article 1
Annexes I to V and VII to Directive 87/402/EEC are hereby amended in accordance with the Annex to this Directive.
Article 2
1. From 1 July 2001, Member States may not:
- refuse, for a type of tractor, to grant EC type-approval or issue the document provided for in the third indent of Article 10(1) of Directive 74/150/EEC, or to grant national type-approval, or
- prohibit the first entry into service of tractors,
if those tractors comply with the requirements of Directive 87/402/EEC, as amended by this Directive.
2. From 1 January 2002, Member States:
- may no longer issue the document provided for in the third indent of Article 10(1) of Directive 74/150/EEC for a type of tractor if it does not comply with the requirements of Directive 87/402/EEC, as amended by this Directive,
- may refuse to grant national type-approval for a type of tractor if it does not comply with the requirements of Directive 87/402/EEC, as amended by this Directive.
Article 3
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 2001 at the latest. They shall forthwith inform the Commission thereof.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the main provisions of national law that they adopt in the field covered by this Directive.
Article 4
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 5
This Directive is addressed to the Member States.
|
[
"UKSI20011710"
] |
32000L0027
|
2000
|
Council Directive 2000/27/EC of 2 May 2000 amending Directive 93/53/EEC introducing minimum Community measures for the control of certain fish diseases
Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the European Parliament(2),
Having regard to the opinion of the Economic and Social Committee(3),
Whereas:
(1) Council Directive 93/53/EEC(4) lays down that, in order to control an outbreak of, inter alia, infectious salmon anaemia (ISA), all fish in an infected farm are to be immediately withdrawn.
(2) In May 1998, an outbreak of this disease occurred in Scotland, involving a number of sites that are infected or are suspected of being infected.
(3) Experience gained has shown that it is possible to spread the withdrawal over a period of time, without impairing the efforts to eradicate the disease.
(4) Under certain conditions, the application of provisions on vaccination may offer a new tool for controlling and containing ISA after an outbreak; at present no such option is provided for under Community legislation.
(5) It is desirable to investigate fully the source of ISA, possible spread of the disease and the interchange between farmed and wild salmon.
(6) No Community compensation has been payable to salmon farmers for the compulsory withdrawal of entire salmon farms under Directive 93/53/EEC.
(7) The measures necessary for the implementation of Directive 93/53/EEC are to be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(5).
(8) Given the current state of scientific and technical evidence, Directive 95/53/EEC should therefore be amended accordingly.
(9) Given the urgency of the matter it is imperative to grant an exception to the six-week period mentioned in part I point (3) of the Protocol on the role of national parliaments of the European Union annexed to the Treaty of Amsterdam,
Article 1
Directive 93/53/EEC is hereby amended as follows:
1. The first indent of point (a) of Article 6 shall be replaced by the following text:
"- all fish shall be withdrawn in accordance with a scheme established by the official service and approved by the Commission in accordance with the procedure laid down in Article 19(2)."
2. Paragraph 1 of Article 14 shall be replaced by the following text:
"1. Vaccination against list II diseases in approved zones, in approved farms situated in non-approved zones or in zones or farms which have already begun the approval procedures laid down by Directive 91/67/EEC and against list I diseases shall be forbidden.
However, by way of derogation, vaccination may be authorised in the case of an outbreak of list I diseases provided the procedures for vaccination are specified in the approved contingency plans in accordance with Article 15 and account is taken of the criteria set out in Annex E."
3. A new Article shall be added:
"Article 18a
The measures necessary for the implementation of this Directive concerning the measures referred to in the Articles listed hereinafter are to be adopted in accordance with the regulatory procedures referred to in Article 19(2):
- Article 5(2),
- Article 6,
- Article 10(1) and (2),
- Article 12,
- Article 15,
- Article 16
- Article 18, second subparagraph."
4. Article 19 shall be replaced with the following:
"Article 19
1. The Commission shall be assisted by the Standing Veterinary Committee established by Decision 68/361/EEC(6), hereinafter referred to as the Committee.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.
The period provided for in Article 5(6) of Decision 1999/468/EC shall be three months.
3. The Committee shall adopt its rules of procedure."
5. Annex E attached to this Directive shall be adopted.
Article 2
Member States shall bring into force the laws, regulations and administrative provisions to comply with this Directive by 31 December 2000. They shall forthwith inform the Commission thereof.
They shall apply those provisions not later than 1 January 2001.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive. The Commission shall inform the other Member States thereof.
Article 3
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20020284"
] |
32000L0029
|
2000
|
Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community
Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament(1),
Having regard to the opinion of the Economic and Social Committee(2),
Whereas:
(1) Council Directive 77/93/EEC of 21 December 1976, on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(3). For the sake of clarity and rationality, it has been amended on a number of occasions, often substantively(4). It should therefore be consolidated.
(2) Plant production is very important to the Community.
(3) Plant production yields are consistently reduced through the effects of harmful organisms.
(4) The protection of plants against such organisms is absolutely necessary not only to avoid reduced yields but also to increase agricultural productivity.
(5) Action aimed at the systematic eradication of harmful organisms within the Community, established by the plant health regime applicable in the Community as an area without internal frontiers, would have only limited effect if protective measures against their introduction into the Community were not applied at the same time.
(6) The need for such measures has long been recognised and they have formed the subject of many national regulations and international conventions, including the International Plant Protection Convention (IPPC) of 6 December 1951 concluded at the United Nations Food and Agricultural Organisation (FAO), which is of worldwide interest.
(7) One of the most important measures consists in listing the particularly dangerous harmful organisms whose introduction into the Community must be prohibited and also the harmful organisms whose introduction into the Member States when carried by certain plants or plant products must also be prohibited.
(8) The presence of some of these harmful organisms, when plants or plant products are introduced from countries in which these organisms occur, cannot be effectively checked. It is therefore necessary to make minimum provision for bans on the introduction of certain plants and plant products, or to provide for special checks to be made in the producer countries.
(9) Such plant health checks must be limited to introductions of products originating in non-member countries and to cases where there is strong evidence that one of the plant-health provisions has not been observed.
(10) It is necessary to make provision under certain conditions permitting derogations from a certain number of provisions. Experience has shown that the same degree of urgency may be attached to a certain number of derogations as is attached to the safeguard provisions. Therefore the urgency procedure specified in this Directive should also be made applicable to these derogations.
(11) Temporary safeguard measures not laid down in this Directive should normally be adopted by the Member State where the problem originates in the case of imminent danger of the introduction or spread of harmful organisms. The Commission should be informed of all events which require the adoption of safeguard measures.
(12) Given the importance of the trade in plants and plant products between the French overseas departments and the remainder of the Community, it is desirable to apply the provisions of this Directive to them. In view of the special nature of the agricultural production of the French overseas departments, it is appropriate to provide for additional protective measures justified on grounds of the protection of health and life of plants therein. The provisions of this Directive should also be extended to protective measures against the introduction of harmful organisms into the French overseas departments from other parts of France.
(13) Council Regulation (EEC) No 1911/91 of 26 June 1991 on the applications of the provisions of Community law to the Canary Islands(5) integrates the Canary Islands into the Community customs territory and into the common policies. Under Articles 2 and 10 of that Regulation, application of the common agricultural policy is subject to the entry into force of specific supply arrangements. Such application must also be accompanied by specific measures concerning agricultural production.
(14) Council Decision 91/314/EEC of 26 June 1991 setting up a programme of options specific to the remote and insular nature of the Canary Islands (Poseican)(6) outlines the options to be implemented to take account of the specific problems and constraints faced by those islands.
(15) To accommodate therefore the specific plant health situation in the Canary Islands, it is appropriate to extend the application of certain measures of this Directive for a period expiring six months after the date by which Member States must have implemented forthcoming provisions dealing with the Annexes to this Directive for the protection of the French overseas departments and of the Canary Islands.
(16) It is appropriate to adopt, for the purposes of this Directive, the model certificates approved under the IPPC, as amended on 21 November 1979, in a standardised lay-out which has been drawn up in close cooperation with international organisations. It is also appropriate to lay down certain rules concerning the conditions in accordance with which such certificates may be issued, certain rules for the use of previous models during a transitional period, and certification requirements in the case of the introduction of plants and plant products from third countries.
(17) In the case of importations of plants or plant products from third countries the authorities responsible in such countries for issuing certificates should be, in principle, those empowered under the IPPC. It could be desirable to establish lists of these authorities for the non-contracting third countries.
(18) The procedure applicable to certain types of amendments to be made to the Annexes to this Directive should be simplified.
(19) The scope of this Directive should be clarified in respect of "wood". In particular, it is useful to follow the detailed descriptions of "wood" set out in Community Regulations.
(20) Certain seeds are not included amongst the plants, plant products and other objects, listed in the Annexes to this Directive, which must be subjected to a plant health inspection in the country of origin or the consignor country before being permitted to enter in the Community or in intra-Community trade.
(21) It is appropriate to provide in certain cases that the official inspection of plants, plant products and other objects coming from third countries should be carried out by the Commission in the third country of origin.
(22) The Community inspections must be made by experts employed by the Commission, and also by experts employed by Member States, whose services are made available to the Commission. The roles of these experts should be defined in connection with the activities required under the Community plant health regime.
(23) The scope of the regime should no longer be restricted to trade between Member States and third countries, but should also be extended to marketing within single Member States.
(24) In principle, all parts of the Community should benefit from the same degree of protection against harmful organisms. However, differences in ecological conditions and in the distribution of certain harmful organisms must be taken into account. In consequence, "protected zones" exposed to particular plant health risks should be defined and should be accorded special protection under conditions compatible with the internal market.
(25) The application of the Community plant health regime to the Community as an area without internal frontiers, and the introduction of protected zones make it necessary to distinguish between requirements applicable to Community products on the one hand and those applicable to imports from third countries on the other, and to identify harmful organisms relevant for protected zones.
(26) The most appropriate place for carrying out plant-health checks is the place of production. In respect of Community products, these checks must therefore be made mandatory at the place of production and should extend to all relevant plants and plant products grown, produced, used or otherwise present there, and to the growing medium used there. For the efficient operation of such a system of checks, all producers should be officially registered.
(27) To ensure more effective application of the Community plant-health regime in the internal market, it must be possible to use, for the purpose of plant-health checks, available official manpower other than that of Member States' official plant-protection services, whose training should be coordinated and supported financially by the Community.
(28) If the results of the checks are satisfactory, instead of the phytosanitary certificate used in international trade, Community products will bear an agreed mark (plant passport), adapted to the type of product, in order to ensure its free movement throughout the Community or those parts thereof for which it is valid.
(29) The official measures to be taken when the results of the checks are not satisfactory should be specified.
(30) To ensure compliance with the Community plant-health regime in the context of the internal market, a system of official checks during marketing should be established. This system should be as reliable and uniform as possible throughout the Community but should exclude specific controls at borders between Member States.
(31) In the framework of the internal market, products originating in third countries should in principle be subjected to plant-health checks on first introduction into the Community. If the results of the checks are satisfactory, third country products should be issued with a plant passport ensuring free movement in the same way as Community products.
(32) In order to confront the situation created by the completion of the internal market with the necessary guarantees, it is essential to reinforce the plant-health inspection infrastructure at national and Community level at the Community's external frontiers, paying particular attention to those Member States which, by reason of their geographical situation, are points of entry to the Community. The Commission will propose the inclusion in the General Budget of the European Union of the necessary appropriations for that purpose.
(33) With a view to improving the efficiency of the Community plant-health regime in the context of the internal market, the Member States should harmonise the practices of the personnel responsible for plant-health. The Commission will submit, before 1 January 1993, a Community code of plant-health practice.
(34) It is no longer possible for Member States to adopt any special plant-health provisions on the introduction into their territory of plants or plant products originating in other Member States. All provisions on plant-health requirements for plants and plant products should be established at Community level.
(35) It is necessary to establish a system of Community financial contributions to share at Community level the burden of possible risks which might remain in trade under the Community plant-health regime.
(36) In order to prevent infections by harmful organisms introduced from third countries, there should be a Community financial contribution aimed at reinforcing the plant health inspection infrastructure at the Community's external frontiers.
(37) The regime should also provide for adequate contributions to certain expenses for specific measures, which Member States have adopted to control and, where applicable, eradicate infections by harmful organisms introduced from third countries or from other areas in the Community, and, where possible, to repair the damage caused.
(38) The details of the mechanism for granting the Community financial contribution should be determined under a rapid procedure.
(39) It must be ensured that the Commission is informed in full of the possible causes for the introduction of the harmful organisms concerned.
(40) In particular, the Commission should monitor correct application of the Community plant-health regime.
(41) It should be established that the introduction of the harmful organisms has been caused by inadequate examinations or inspections. Community law should apply in respect of the consequences, taking into account certain specific measures.
(42) It is appropriate for Member States and the Commission to cooperate closely within the Standing Committee on Plant Health set up by Council Decision 76/894/EEC(7).
(43) This Directive must not affect the obligations of the Member States concerning the time-limits for transposition and application set out in Annex VIII, Part B,
Article 1
1. This Directive concerns protective measures against the introduction into the Member States from other Member States or third countries of organisms which are harmful to plants or plant products.
It also concerns:
(a) with effect from 1 June 1993, protective measures against the spread of harmful organisms within the Community by means related to movements of plants, plant products and other related objects within a Member State;
(b) protective measures against the introduction of harmful organisms into the French overseas departments from other parts of France and, conversely, into other parts of France from the French overseas departments;
(c) protective measures against the introduction of harmful organisms into the Canary Islands from other parts of Spain and, conversely, into other parts of Spain from the Canary Islands.
2. Without prejudice to the conditions to be established for the protection of the plant-health situation existing in certain regions in the Community, taking into account the differences in agricultural and ecological conditions, protective measures which are justified on grounds of the protection of health and life of plants in the French overseas departments and in the Canary Islands which are additional to those laid down in this Directive may be determined in accordance with the procedure laid down in Article 18.
3. This Directive shall not apply to Ceuta or Melilla.
4. Each Member State shall establish or designate one single and central authority responsible, under the control of the national government, in particular for coordination and contacts in matters related to plant health within the context of this Directive. The official plant protection service set up under the International Plant Protection Convention (IPPC) shall preferably be designated for this purpose. This authority and any subsequent change shall be notified to the other Member States and to the Commission.
5. In respect of the protective measures against the introduction of harmful organisms from the French overseas departments into other parts of France and into the other Member States and against their spread within the French overseas departments, the dates referred to in paragraph 1(a) of this Article, Article 3(4), Article 4(2) and (4), Article 5(2) and (4), Article 6(5) and (6), Article 10(1) and (2) and Article 13(8), (10) and (11) shall be replaced by a date which corresponds to the end of a six-month period following the date by which Member States must implement forthcoming provisions dealing with Annexes I to V for the protection of the French overseas departments. With effect from the same date, paragraph 1(b) and paragraph 2 of this Article shall be deleted.
6. In respect of the protective measures against the introduction of harmful organisms from the Canary Islands into other parts of Spain and into the other Member States and against their spread within the Canary Islands, the dates referred to in paragraph 1(a) of this Article, Article 3(4), Article 4(2) and (4), Article 5(2) and (4), Article 6(5) and (6), Article 10(1) and (2) and Article 13(8), (10) and (11) shall be replaced by a date which corresponds to the end of a six-month period following the date by which Member States must implement forthcoming provisions dealing with Annexes I to V for the protection of the Canary Islands. With effect from the same date, paragraph 1(c) of this Article shall be deleted.
Article 2
1. For the purposes of this Directive:
(a) plants shall be considered to mean: living plants and living parts thereof, including seeds;
living parts of plants shall be considered to include:
- fruit, in the botanical sense, other than that preserved by deep freezing,
- vegetables, other than those preserved by deep freezing,
- tubers, corms, bulbs, rhizomes,
- cut flowers,
- branches with foliage,
- cut trees retaining foliage,
- plant tissue cultures.
seeds shall be considered to mean: seeds in the botanical sense, other than those not intended for planting;
(b) plant products shall be considered to mean: products of plant origin, unprocessed or having undergone simple preparation, in so far as these are not plants;
(c) planting shall be considered to mean: any operation for the placing of plants to ensure their subsequent growth, reproduction or propagation;
(d) plants intended for planting shall be considered to mean:
- plants which are already planted and are intended to remain planted or to be replanted after their introduction, or
- plants which are not planted at the time of introduction, but are intended to be planted thereafter;
(e) harmful organisms shall be considered to mean: pests of plants or of plant products, which belong to the animal or plant kingdoms, or which are viruses, mycoplasmas or other pathogens;
(f) plant passport shall be considered to mean: an official label which gives evidence that the provisions of this Directive related to plant health standards and special requirements are satisfied, and which is:
- standardised at Community level for different types of plants or plant products, and
- prepared by the responsible official body in a Member State and issued in accordance with the implementing rules governing the details of the procedure for issuing plant passports.
For specific types of product, official agreed marks other than a label may be decided on in accordance with the procedure laid down in Article 18.
The standardisation shall be established in accordance with the procedure laid down in Article 8. Under this standardisation, different marks shall be determined for plant passports which are not valid, in accordance with the second subparagraph of Article 10(1), for all parts of the Community;
(g) the responsible official bodies in a Member State shall be:
(i) the official plant protection service(s) of a Member State referred to in Article 1(4); or
(ii) any State authority established
- at national level,
- or, under the supervision within the limits set by the constitution of the Member State concerned, of national authorities at regional level.
The responsible official bodies in a Member State may, in accordance with national legislation, delegate the tasks provided for in this Directive to be accomplished under their authority and supervision to any legal person, whether governed by public or by private law, which under its officially approved constitution is charged exclusively with specific public functions, provided that such person, and its members, has no personal interest in the outcome of the measures it takes.
The Member States shall ensure that there is close cooperation between the bodies referred to in point (ii) of the first subparagraph and those referred to in point (i) thereof.
Moreover, in accordance with the procedure laid down in Article 18, other legal persons established on behalf of the body or bodies referred to in point (i) of the first subparagraph and acting under the authority and supervision of such body may be approved, provided that such person has no personal interest in the outcome of the measures it takes.
The single central authority referred to in Article 1(4) shall inform the Commission of the responsible official bodies in the Member State concerned. The Commission shall forward that information to the other Member States;
(h) protected zone shall be considered to mean a zone in the Community:
- in which one or more harmful organisms referred to in this Directive, which are established in one or more parts of the Community, are not endemic or established despite favorable conditions for them to establish themselves there,
- in which there is a danger that certain harmful organisms will establish, given propitious ecological conditions, for particular crops, despite the fact that these organisms are not endemic or established in the Community,
and which has been recognised, in accordance with the procedure laid down in Article 18, as fulfilling the conditions set out in the first and second indents and, in the case referred to in the first indent, at the request of the Member State(s) concerned and on the grounds that the results of appropriate surveys which have been monitored by the experts referred to in Article 21 under the procedure laid down therein show no evidence to the contrary. In the eventuality referred to in the second indent, surveys are optional.
A harmful organism shall be considered to be established in an area if it is known to occur there and if either no official measures have been taken there with a view to its eradication or such measures have proved, for a period of at least two successive years, to be ineffective.
The Member State(s) concerned shall conduct, with respect to the case provided for in the first indent of the first subparagraph, regular and systematic official surveys on the presence of organisms in respect of which the protected zone has been recognised. Each finding of such organisms shall immediately be notified to the Commission. The risk arising from such finding shall be assessed by the Standing Committee on Plant Health and appropriate action decided on in accordance with the procedure referred to in Article 18.
The details of the surveys referred to in the first and third subparagraphs may be established in accordance with the procedure referred to in Article 18, account being taken of sound scientific and statistical principles.
The results of the above surveys shall be notified to the Commission. The Commission shall forward this information to the other Member States.
The Commission shall, before 1 January 1998, submit a report to the Council on the operation of the system of protected zones together, if necessary, with any appropriate proposals;
(i) a statement or measure shall be considered official if made or taken, without prejudice to the provisions of Article 21:
- by representatives of the official plant protection service of a Member State or, under their responsibility, by other public servants, in the case of statements or measures related to the issuing of the certificates specified in Article 7(1) or Article 8(2);
- either by such representatives or public servants or by qualified agents employed by one of the responsible official bodies of a Member State, in all other cases, provided that such agents have no personal interest in the outcome of the measures they take and satisfy minimum standards of qualification.
Member States shall ensure that their public servants and qualified agents have the qualifications necessary for the proper application of this Directive. In accordance with the procedure laid down in Article 18, guidelines may be established for such qualifications.
The Commission shall, acting within the Standing Committee on Plant Health, draw up Community programmes, the implementation of which it shall monitor, regarding the further training of the public servants and qualified agents concerned, in an effort to raise the knowledge and experience acquired in the national context to the level of the aforementioned qualifications. It shall contribute to the financing of this further training and shall propose the inclusion of the necessary appropriations for that purpose in the Community budget.
2. Save where it is expressely provided otherwise, the provisions of this Directive concern wood only in so far as it retains all or part of its natural round surface, with or without bark, or as it is in the form of chips, particles, sawdust, wood waste or scrap.
Save for the purpose of the provisions relating to Annex V, wood, whether satisfying the conditions referred to in the first subparagraph or not, is also concerned where it is in the form of dunnage, spacers, pallets or packing material which are actually in use in the transport of objects of all kinds, provided that it presents a plant health risk.
Article 3
1. Member States shall ban the introduction into their territory of the harmful organisms listed in Annex I, Part A.
2. Member States shall ban the introduction into their territory of the plants and plant products listed in Annex II, Part A, where they are contaminated by the relevant harmful organisms listed in that part of the Annex.
3. Paragraphs 1 and 2 shall not apply in accordance with conditions which may be determined in accordance with the procedure laid down in Article 17, in the case of slight contamination of plants other than those intended for planting by harmful organisms listed in Annex I, Part A, or in Annex II, Part A, which have previously been selected in agreement with the authorities representing the Member States in the field of plant health.
4. With effect from 1 June 1993, Member States shall provide that paragraphs 1 and 2 shall be applied also to the spread of the harmful organisms concerned by means connected with the movement of plants, plant products or other objects within the territory of a Member State.
5. Member States shall ban from 1 June 1993 the introduction into and the spread within the relevant protected zones, of:
(a) the harmful organisms listed in Annex I, Part B;
(b) the plants and plant products listed in Annex II, Part B where they are contaminated by the relevant harmful organisms listed therein.
6. In accordance with the procedure laid down in Article 18:
(a) the harmful organisms listed in Annexes I and II shall be subdivided as follows:
- organisms not known to occur in any part of the Community and relevant for the entire Community shall be listed in Annex I, Part A, Section I and Annex II, Part A, Section I respectively,
- organisms known to occur in the Community but not endemic or established throughout the Community and relevant for the entire Community shall be listed in Annex I, Part A, Section II and Annex II, Part A, Section II respectively,
- the other organisms shall be listed in Annex I, Part B and Annex II, Part B respectively against the protected zone for which they are relevant;
(b) harmful organisms endemic or established in one or more parts of the Community shall be deleted, save those referred to in the second and third indents of point (a);
(c) the titles of Annexes I and II, as well as the different parts and sections thereof, shall be adapted in accordance with points (a) and (b).
7. In accordance with the procedure laid down in Article 18, save where it is expressly provided otherwise, it may be decided that Member States shall lay down that:
(a) the introduction into their territories, and the spread within their territories, of specified organisms, whether singly or not, which are considered to be harmful to plants or plant products but are not listed in Annexes I and II, shall be prohibited or require special authorisation under conditions specified under the same procedure;
(b) the introduction into their territories, and the spread within their territories, of specified organisms, which are listed in Annex II, but which occur on plants other than those listed in that Annex, and which are considered to be harmful to plants or plant products, shall be prohibited or require special authorisation under conditions specified under the same procedure;
(c) the introduction into their territories, and the spread within their territories, of specified organisms, which are listed in Annexes I and II, which are in an isolated state and which are considered to be harmful to plants or plant products, shall be prohibited or require special authorisation under conditions specified under the same procedure.
The first subparagraph shall also apply to such organisms where they are not affected by Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms(8), or other more specific Community provisions regarding genetically modified organisms.
Paragraphs 1 and 5(a) and paragraphs 2 and 5(b) and paragraph 4 shall not apply, in accordance with the conditions which shall be determined pursuant to the procedure laid down in Article 18, for trial or scientific purposes and for work on varietal selections.
After the measures provided for in the first subparagraph have been adopted, that subparagraph shall not apply, in accordance with the conditions which shall be determined pursuant to the procedure laid down in Article 18, for trial or scientific purposes and for work on varietal selections.
Article 4
1. Member States shall ban the introduction into their territory of the plants or plant products listed in Annex III, Part A where they originate in the relevant countries referred to in that part of the Annex.
2. Member States shall provide that, from 1 June 1993, the introduction of plants, plant products and other objects listed in Annex III, Part B into the relevant protected zones located in their territory is prohibited.
3. In accordance with the procedure laid down in Article 18, Annex III shall be revised in such a way that Part A contains plants, plant products and other objects which constitute a plant-health risk for all parts of the Community, and Part B contains plants, plant products and other objects which constitute a plant-health risk only for protected zones. The protected zones shall be specified there.
4. With effect from 1 June 1993, paragraph 1 shall no longer apply to plants, plant products and other objects originating in the Community.
5. Paragraphs 1 and 2 shall not apply, in accordance with conditions which shall be determined pursuant to the procedure laid down in Article 18, for trials or scientific purposes and for work on varietal selections.
6. Provided that there is no risk of harmful organisms spreading, a Member State may provide that paragraphs 1 and 2 shall not apply in individual specified cases to plants, plant products and other objects which are grown, produced or used in its immediate frontier zone with a third country and introduced into that Member State in order to be worked in nearby locations in the frontier zone of its territory.
When granting such a derogation, the Member State shall specify the location and the name of the person working it. Such details, which shall be updated regularly, shall be available to the Commission.
Plants, plant products and other objects which form the subject of a derogation under the first subparagraph shall be accompanied by documentary evidence of the location in the relevant third country from which the said plants, plant products and other objects originate.
Article 5
1. Member States shall ban the introduction into their territory of the plants, plant products and other objects listed in Annex IV, Part A, unless the relevant special requirements indicated in that part of the Annex are met.
2. Member States shall ban from 1 June 1993 the introduction into and the movement within the protected zones of the plants, plant products and other objects listed in Annex IV, Part B, unless the relevant special requirements indicated in that part of the Annex are met.
3. In accordance with the procedure laid down in Article 18, Annex IV shall be amended in accordance with the criteria laid down in Article 3(6).
4. With effect from 1 June 1993, Member States shall provide that paragraph 1 shall also apply to the movement of plants, plant products and other objects within the territory of a Member State, without prejudice however to Article 6(7). This paragraph and paragraphs 1 and 2 shall not apply to the movement of small quantities of plants, plant products, foodstuffs or animal feedingstuffs where they are intended for use by the owner or recipient for non-industrial and non-commercial purposes or for consumption during transport, provided that there is no risk of harmful organisms spreading.
5. Paragraphs 1, 2 and 4 shall not apply, in accordance with the conditions which shall be determined pursuant to the procedure laid down in Article 18, for trial or scientific purposes and for work on varietal selections.
6. Provided that there is no risk of harmful organisms spreading, a Member State may provide that paragraphs 1, 2 and 4 shall not apply in individual specified cases to plants, plant products and other objects which are grown, produced or used in its immediate frontier zone with a third country and introduced into that Member State in order to be worked in nearby locations in the frontier zone of its territory.
When granting such a derogation, the Member State shall specify the location and the name of the person working it. Such details which shall be updated regularly, shall be available to the Commission.
Plants, plant products and other objects which form the subject of a derogation under the first subparagraph shall be accompanied by documentary evidence of the location in the relevant third country from which the said plants, plant products and other objects originate.
Article 6
1. Member States shall lay down, at least in respect of the introduction into another Member State of the plants, plant products and other objects listed in Annex V, Part A, that the latter and their packaging shall be meticulously examined on an official basis, either in their entirety or by representative sample, and that, if necessary, the vehicles transporting them shall also be officially examined in order to make sure:
(a) that they are not contaminated by the harmful organisms listed in Annex I, Part A;
(b) in the case of the plants and plant products listed in Annex II, Part A, that they are not contaminated by the relevant harmful organisms listed in that part of the Annex;
(c) in the case of the plants, plant products and other objects listed in Annex IV, Part A, that they comply with the relevant special requirements indicated in that part of the Annex.
2. As soon as the measures provided for in Article 3(6)(a) and in Article 5(3) are adopted, paragraph 1 of this Article shall apply only in respect of Annex I, Part A, Section II, Annex II, Part A, Section II and Annex IV, Part A, Section II. Where, in the course of the examination carried out in accordance with this provision, harmful organisms listed in Annex I, Part A, Section I or Annex II, Part A, Section I are detected, the conditions referred to in Article 10 are deemed not to be fulfilled.
3. Member States shall lay down the inspection measures referred to in paragraph 1 in order to ensure compliance with Article 3(4), (5) and (7) or Article 5(2), where the Member State of destination avails itself of one of the options listed in the abovementioned Articles.
4. Member States shall lay down that the seeds referred to in Annex IV, Part A, which are to be introduced into another Member State shall be officially examined in order to make sure that they comply with the relevant special requirements listed in that part of the Annex.
5. With effect from 1 June 1993, and without prejudice to paragraph 7, paragraphs 1, 3 and 4 shall also apply to the movement of plants, plant products and other objects within the territory of a Member State. Paragraphs 1, 3 and 4 shall not apply, as regards the harmful organisms listed in Annex I, Part B, or Annex II, Part B, and the special requirements set out in Annex IV, Part B, to the movement of plants, plant products or other objects through or outside a protected zone.
The official examinations referred to in paragraphs 1, 3 and 4 shall be carried out in accordance with the following provisions:
(a) They shall extend to the relevant plants or plant products grown, produced or used by the producer or otherwise present on his premises as well as to the growing medium used there.
(b) They shall be made on the premises, preferably at the place of production.
(c) They shall be made regularly at appropriate times at least once a year, and at least by visual observation, without prejudice to the special requirements listed in Annex IV; further action may be taken where this is provided for under paragraph 8.
Any producer for whom the official examination referred to in the second subparagraph is required under paragraphs 1 to 4 shall be listed in an official register under a registration number by which to identify him. The official registers thus established shall be accessible to the Commission on request.
The producer is subject to certain obligations established in accordance with paragraph 8. In particular, he shall immediately notify the responsible official body of the Member State concerned of any unusual occurrence of harmful organisms, symptoms or any other plant abnormality.
Paragraphs 1, 3 and 4 shall not apply to the movement of small quantities of plants, plant products, foodstuffs or animal feedingstuffs where they are intended for use by the owner or recipient for non-industrial and non-commercial purposes or for consumption during transport, provided that there is no risk of harmful organisms spreading.
6. With effect from 1 June 1993, Member States shall provide that producers of certain plants, plant products or other objects not listed in Annex V, Part A, specified in accordance with paragraph 8, or collective warehouses or dispatching centres in the production zone, shall also be listed in an official local, regional or national register in accordance with the third subparagraph of paragraph 5. They may at any time be subjected to the examinations provided for in the second subparagraph of paragraph 5.
In accordance with paragraph 8, a system may be set up so that certain plants, plant products and other objects may, if necessary and in so far as possible, be traced back to their origins, bearing in mind the nature of the production or trading conditions.
7. Member States may, in so far as no spreading of harmful organisms is to be feared, exempt
- small producers or processors whose entire production and sale of relevant plants, plant products and other objects are intended for final usage by persons on the local market and who are not professionally involved in plant production (local movement) from official registration as laid down in paragraphs 5 and 6, or
- the local movement of plants, plant products and other objects originating from producers so exempted from the official examination required under paragraphs 5 and 6.
The provisions of this Directive on local movement shall be reviewed by the Council before 1 January 1998 on the basis of a Commission proposal and in the light of experience gained.
8. In accordance with the procedure laid down in Article 18, implementing provisions shall be adopted relating to:
- less stringent conditions on the movement of plants, plant products and other objects within a protected zone established for the said plants, plant products and other objects in respect of one or more harmful organisms,
- guarantees in respect of the movement of plants, plant products and other objects through a protected zone established for the said plants, plant products and other objects in respect of one or more harmful organisms,
- the frequency and timing of the official examination, including further action referred to in paragraph 5, second subparagraph, (c),
- the obligations on registered producers referred to in paragraph 5, fourth subparagraph,
- the specification of the products referred to in paragraph 6, and the products for which the system introduced in paragraph 6 is envisaged,
- other requirements regarding the exemption referred to in paragraph 7, in particular as regards the concepts of "small producer" and "local market" and the relevant procedures.
9. Implementing rules related to the registration procedure and the registration number referred to in the third subparagraph of paragraph 5, may be adopted in accordance with the procedure laid down in Article 18.
Article 7
1. Where it is considered, on the basis of the examination laid down in Article 6(1) and (3), that the conditions therein are fulfilled, a phytosanitary certificate conforming to the model in Annex VII, Part A, may be issued, drawn up in at least one of the official languages of the Community and filled in, except in respect of stamp and signature, either entirely in capital letters or entirely in typescript, and preferably in one of the official languages of the Member State of destination.
The botanical names of plants shall be indicated in Latin characters. Uncertified alterations or erasures shall invalidate the certificate. Any copies of this certificate shall only be issued with the indication "copy" or "duplicate" printed or stamped thereon.
2. Member States shall lay down that the plants, plant products and other objects listed in Annex V, Part A, may not be introduced into another Member State unless they are accompanied by a phytosanitary certificate issued in accordance with paragraph 1. The phytosanitary certificate may not be made out more than 14 days before the date on which the plants, plant products or other objects leave the consignor Member State.
3. The action to be taken by the Member States in order to implement Article 6(3), in so far as seeds referred to in Annex IV, Part B are concerned, and Article 6(4) shall be determined in accordance with the procedure laid down in Article 17 by 31 December 1991 at the latest.
Article 8
1. Unless one of the eventualities provided for in paragraph 2 arises, Member States shall lay down that the plants, plant products and other objects listed in Annex V, Part A, which have been introduced into their territory from a Member State and which are to be introduced into the territory of another Member State shall be exempted from a further inspection complying with Article 6, if they are accompanied by a phytosanitary certificate from a Member State, made out in accordance with the specimen in Annex VII, Part A.
2. Where plants, plant products or other objects from one Member State have been split up or stored or their packaging changed in a second Member State and are then introduced into a third Member State, the second Member State shall not be required to make a new inspection complying with Article 6 if it is officially ascertained that these products have not been subject in its territory to any risk which would call in question compliance with the conditions laid down in Article 6. In this case a reforwarding phytosanitary certificate, in one original copy only, conforming to the model laid down in Annex VII, Part B, drawn up in at least one of the official languages of the Community, and filled in, except in respect of stamp and signature, either entirely in capital letters or entirely in typescript, and preferably in one of the official languages of the Member State of destination shall be issued. This certificate must be attached to the phytosanitary certificate issued by the first Member State or to a certified copy of that certificate. This certificate may be entitled "phytosanitary certificate for re-export". Article 8(1), second subparagraph, shall apply mutatis mutandis.
The re-forwarding phytosanitary certificate may not be made out more than 14 days before the date on which the plants, plant products or other objects leave the reforwarding country.
3. Paragraphs 1 and 2 shall also apply when plants, plant products or other objects are introduced successively into several Member States. If, in that case, more than one reforwarding certificate has been issued, the products must be accompanied by the following documents:
(a) the latest phytosanitary certificate or a certified copy thereof;
(b) the latest reforwarding phytosanitary certificate;
(c) the reforwarding phytosanitary certificates previous to the certificate referred to under (b) or certified copies thereof.
Article 9
1. In the case of plants, plant products or other objects to which special requirements laid down in Annex IV, Part A apply, the official phytosanitary certificate required pursuant to Article 7 shall have been issued in the country in which the plant, plant products and other objects originate, save:
- in the case of wood, if under the special requirements laid down in Annex IV, Part A, it is sufficient that it is stripped of its bark,
- in other cases, to the extent that the special requirements laid down in Annex IV, Part A, can be fulfilled also at places other than that of origin.
2. Paragraph 1 shall also apply to the introduction of the plants and plant products listed in Annex IV, Part B into the Member States whose names are indicated against those products in that part of the Annex.
Article 10
1. With effect from 1 June 1993, where it is considered, on the basis of the examination provided for in Article 6(1), (3) and (4) and carried out in accordance with Article 6(5), that the conditions of those paragraphs are fulfilled, a plant passport shall be issued in accordance with provisions which may be adopted under paragraph 4 of this Article, instead of the phytosanitary certificates referred to in Articles 7 or 8.
If the examination does not concern conditions relevant to the protected zones, or if it is considered that such conditions are not fulfilled, the plant passport issued shall not be valid for those zones and it shall bear the mark reserved for such cases, pursuant to Article 2(1)(f).
2. With effect from 1 June 1993, plants, plant products and other objects listed in Annex V, Part A, Section I, may not be moved within the Community, other than locally within the meaning of Article 6(7), unless a plant passport valid for the territory concerned and issued in accordance with paragraph 1 is attached to them, to their packaging or to the vehicles transporting them.
With effect from 1 June 1993, plants, plant products and other objects listed in Annex V, Part A, Section II, may not be introduced into a specified protected zone or move therein, unless a plant passport valid for that zone and issued in accordance with paragraph 1 is attached to them, to their packaging or to the vehicles transporting them. If the conditions laid down in Article 6(8) with regard to transport through protected zones are fulfilled, this subparagraph shall not apply.
The first and second subparagraphs shall not apply to the movement of small quantities of plants, plant products, foodstuffs or animal feedingstuffs where they are intended for use by the owner or recipient for non-industrial and non-commercial purposes or for consumption during transport, provided that there is no risk of harmful organisms spreading.
3. A plant passport may be replaced at a later date and in any part of the Community by another plant passport, in accordance with the following provisions:
- a plant passport may be replaced only where consignments are divided up or where several consignments or parts thereof are combined or where the plant-health status of consignments changes, without prejudice to the particular requirements provided for in Annex IV, or in other cases specified in accordance with paragraph 4,
- the replacement may take place only at the request of a natural or legal person, whether a producer or not, listed in an official register, in accordance with the third subparagraph of Article 6(5), mutatis mutandis,
- the replacement passport may be prepared only by the responsible official body of the area in which the requesting premises are situated and only if the identity of the product concerned and the absence of any risk of infection due to harmful organisms listed in Annexes I and II since dispatch by the producer can be guaranteed,
- the replacement procedure must comply with the provisions which may be adopted under paragraph 4,
- the replacement passport must bear a special mark, specified in accordance with paragraph 4 and including the number of the original producer and, if there was a change in plant-health status, of the operator responsible for that change.
4. In accordance with the procedure laid down in Article 18, implementing provisions may be adopted for:
- the detailed procedures for issuing plant passports as laid down in paragraph 1,
- the conditions under which a plant passport may be replaced in accordance with paragraph 3, first indent,
- the details of the procedure for the replacement passport as laid down in paragraph 3, third indent,
- the special mark required for the replacement passport as laid down in paragraph 3, fifth indent.
Article 11
1. Where it is not considered, on the basis of the examination provided for in Article 6(1), (3) and (4) and carried out in accordance with Article 6(5), that the conditions in those paragraphs are fulfilled, a plant passport shall not be issued, without prejudice to paragraph 2 of this Article.
2. In the special cases where it is established, taking into account the nature of the findings made in the examination concerned, that part of the plants or plant products grown, produced or used by the producer or otherwise present on his premises, or part of the growing medium used there, cannot present any risk of spreading harmful organisms, paragraph 1 shall not apply to that part.
3. To the extent that paragraph 1 applies, the plants, plant products or growing medium concerned shall be the subject of one or more of the following official measures:
- appropriate treatment, followed by the issue of the appropriate plant passport in accordance with Article 10 if it is considered that, as a result of the treatment, the conditions are fulfilled,
- a permit for movement, under official control, to zones where they do not present an additional risk,
- a permit for movement, under official control, to places for industrial processing,
- destruction.
In accordance with the procedure laid down in Article 18, implementing provisions may be adopted concerning:
- the conditions under which one or more of the measures referred to in the first subparagraph must or must not be adopted,
- the particular features of and conditions for such measures.
4. To the extent that paragraph 1 applies, the activities of the producer shall be totally or partially suspended until it is established that the risk of spreading harmful organisms is eliminated. As long as this suspension lasts, Article 10 shall not apply.
5. Where it is considered, on the basis of the official examination carried out in accordance with Article 6(6), that products referred to therein are not free of the harmful organisms listed in Annexes I and II, paragraphs 2, 3 and 4 of this Article shall apply mutatis mutandis.
Article 12
1. The Member States shall not require any additional declaration on the phytosanitary certificates referred to in Articles 7, 8 or 9.
2. If it is ascertained that part of a consignment of plants, plant products or other objects is contaminated by harmful organisms listed in Annexes I and II, the introduction of the other part shall not be prohibited provided that it is not suspected of being contaminated and provided that there appears to be no possibility of harmful organisms spreading.
3. Member States shall lay down that the phytosanitary certificates or reforwarding phytosanitary certificates produced when the plants, plant products or other objects are introduced into their territory shall bear an entry stamp from the competent service showing at least the name of the service and the date of entry.
4. Member States shall ensure that their plant protection organisation inform that of the forwarding Member State of all cases where plants, plant products or other objects coming from that Member State have been intercepted as being subject to prohibitions or restrictions relating to plant-health measures. This information is without prejudice to the measures which the first-mentioned plant protection organisation may deem necessary to take in respect of the intercepted consignment, and shall be given as soon as possible so that the plant protection organisation concerned may study the case with a view, in particular, to taking the steps necessary to prevent further, similar occurrences and, where appropriate and in so far as possible, taking measures in respect of the intercepted consignment which are adequate to the risk level of the case in question. In accordance with the procedure laid down in Article 17, a standardised information system may be set up.
5. With effect from 1 January 1993, Member States shall organise official checks to ensure compliance with the provisions of this Directive, in particular with Article 10(2), which shall be carried out at random and without any discrimination in respect of the origin of the plants, plant products or other objects, and in accordance with the following provisions:
- occasional checks, at any time and at any place where plants, plant products or other objects are moved,
- occasional checks on premises where plants, plant products or other objects are grown, produced, stored or offered for sale, as well as on the premises of purchasers,
- occasional checks at the same time as any other documentary check which is carried out for reasons other than plant health.
The checks must be regular in premises listed in an official register in accordance with Article 10(3) and Article 13(8) and may be regular in premises listed in an official register in accordance with Article 6(6).
The checks may be targeted if facts have come to light to suggest that one or more provisions of this Directive have not been complied with.
6. Commercial purchasers of plants, plant products or other objects shall, as final users professionally engaged in plant production, retain the related plant passports for at least one year, and enter the references in their records.
Inspectors shall have access to the plants, plant products or other objects at any stage in the production and marketing chain. They shall be entitled to make any investigation necessary for the official checks concerned, including those related to the plant passports and the records.
7. The Member States may be assisted in the official checks by the experts referred to in Article 21.
8. Where it is established, through the official checks carried out in accordance with paragraphs 5 and 6, that plants, plant products or other objects present a risk of spreading harmful organisms, they shall be the subject of official measures in accordance with Article 11(3).
Article 13
1. Member States shall lay down, at least as regards the introduction into their territory of the plants, plant products and other objects listed in Annex V, Part B and coming from third countries:
(a) that these plants, plant products and other objects and their packaging shall be meticulously inspected on an official basis, either in their entirety or by representative sample, and that, if necessary, the vehicles transporting them shall also be inspected meticulously on an official basis in order to make sure as far as can be determined:
- that they are not contaminated by the harmful organisms listed in Annex I, Part A,
- in the case of the plants and plant products listed in Annex II, Part A that they are not contaminated by the relevant harmful organisms listed in that part of the Annex,
- in the case of the plants, plant products and other objects listed in Annex IV, Part A that they comply with the relevant special requirements indicated in that part of the Annex;
(b) that they are accompanied by the certificates prescribed in Article 7 or 8 and that a phytosanitary certificate may not be made out more than 14 days before the date on which the plants, plant products or other objects leave the consignor country. The certificates prescribed in Article 7 or 8 shall contain information in accordance with the model defined in the Annex to the IPPC, as amended on 21 November 1979, irrespective of their layout, and shall be issued by authorities empowered for this purpose under the IPPC or, in the case of non-contracting countries, on the basis of laws or regulations of the country. In accordance with the procedure laid down in Article 17, lists of the authorities empowered by the various third countries to issue certificates may be established.
By way of derogation from the first subparagraph, phytosanitary certificates issued in accordance with the model laid down in the Annex to the IPPC, original version, may be used for a transitional period. The date of expiry of such period may be determined in accordance with the procedure laid down in Article 17.
2. Paragraph 1 of this Article shall apply to the cases referred to in Article 6(4) and Article 7(3).
3. Member States may also lay down that consignments coming from third countries, which are not declared to contain plants, plant products or other objects listed in Annex V, Part B shall be officially inspected, where there is serious reason to believe that there has been an infringement of the rules in this respect.
In accordance with the procedure laid down in Article 17:
- the cases may be specified in which such inspections shall be carried out,
- the methods for such inspections may be laid down.
If, at the outcome of the inspection, doubts remain in respect of the identity of the consignment, in particular concerning genus, species or origin, the consignment shall be considered to contain plants, plant products or other objects listed in Annex V, Part B.
4. Provided that there is no risk of harmful organisms spreading:
- paragraphs 1 and 2 of this Article shall not apply where plants, plant products or other objects are directly moved between two places within the Community via the territory of a third country,
- paragraphs 1 and 2 of this Article and Article 4(1) shall not apply in the case of transit through the territory of the Community,
- paragraphs 1 and 2 of this Article shall not apply in the case of small quantities of plants, plant products, foodstuffs or animal feedingstuffs where they are intended for use by the owner or recipient for non-industrial and non-commercial purposes or for consumption during transport.
5. Paragraphs 1 and 2 of this Article shall not apply, in accordance with the conditions which shall be determined pursuant to the procedure laid down in Article 18, for trial or scientific purposes and for work on varietal selections.
6. Provided that there is no risk of harmful organisms spreading, a Member State may provide that paragraphs 1 and 2 shall not apply in individual specified cases to plants, plant products and other objects which are grown, produced or used in its immediate frontier zone with a third country and introduced into that Member State in order to be worked in nearby locations in the frontier zone of its territory.
When granting such a derogation, the Member State shall specify the location and the name of the person working it. Such details, which shall be updated regularly, shall be available to the Commission.
Plants, plant products and other objects which form the subject of a derogation under the first subparagraph shall be accompanied by documentary evidence of the location in the relevant third country from which the said plants, plant products and other objects originate.
7. It may be agreed, in technical arrangements made between the Commission and the competent bodies in certain third countries and approved in accordance with the procedure laid down in Article 18 that activities related to the inspections referred to in paragraph 1(a) of this Article may also be carried out under the authority of the Commission and in accordance with the relevant provisions of Article 21 in the third country concerned, in cooperation with the official plant protection organisation of that country.
8. With effect from 1 June 1993, paragraph 1(a) shall apply, in cases of consignments to a protected zone, to harmful organisms and to the special requirements listed in Part B of Annexes I, II and IV respectively. With effect from the same date, paragraph 1 shall apply on the occasion of the first introduction of the plants, plant products or other objects concerned into the Community, without prejudice to specific agreements concluded in this respect between the Community and certain third countries.
Member States shall provide that importers, whether or not producers, must be included in an official register in accordance with Article 6(5) mutatis mutandis.
The inspections, where they are documentary and identity checks and also checks intended to ensure compliance with the provisions of Article 4, must be made at the same place and at the same time as the other administrative formalities concerning import, including customs formalities.
The inspections, where they are plant-health checks, shall be carried out at the places where the inspections are carried out as referred to in the third subparagraph or near to those places. The competent authorities of the Member States shall forward to the Commission and the other Member States the list of points of entry. However, in these particular cases, plant-health checks may be carried out at the place of destination as long as specific guarantees as regards the transport of the plants, plant products and other objects are provided. Implementing provisions, which may stipulate minimum conditions, shall be adopted in accordance with the procedure laid down in Article 18. Plant-health checks shall be regarded as being an integral part of the formalities referred to in the third subparagraph.
Member States may derogate from the provisions of this paragraph only under the conditions laid down as part of the technical arrangements referred to in paragraph 7.
9. There shall be a Community financial contribution for Member States in order to strengthen inspection infrastructures insofar as they relate to plant-health checks carried out in accordance with the fourth subparagraph of paragraph 8.
The purpose of this contribution shall be to improve the provision, at inspection posts other than those at the place of destination, of the equipment and facilities required to carry out inspection and examination and, where necessary, to carry out the measures provided for in paragraph 11, beyond the level already achieved by complying with the minimum conditions stipulated in the implementing provisions pursuant to paragraph 8, fourth subparagraph.
The Commission shall propose the entry of suitable appropriations for that purpose in the general budget of the European Union.
Within the limits set by the appropriations available for these purposes, the Community contribution shall cover up to 50 % of expenditure relating directly to improving equipment and facilities.
The details shall be laid down in an implementing Regulation, in accordance with the procedure laid down in Article 18.
The allocation and the amount of the Community financial contribution shall be decided in accordance with the procedure laid down in Article 18, in the light of the information and documents submitted by the Member State concerned and, where appropriate, the results of investigations carried out on the Commission's authority by the experts referred to in Article 21, and depending on the appropriations available for the purposes concerned.
10. With effect from 1 June 1993, Article 10(1) and (3) shall apply in the same way to the plants, plant products or other objects referred to in paragraph 1 of this Article in so far as they are listed in Annex V, Part A, and where it is considered, on the basis of the inspection laid down in paragraph 8, that the conditions referred to in paragraph 1 are fulfilled.
11. With effect from 1 June 1993, where it is not considered on the basis of the inspections provided for in paragraph 8, that the conditions referred to in paragraph 1 are fulfilled, one or more of the following official measures shall be taken immediately:
- appropriate treatment where it is considered that, as a result of the treatment, the conditions are fulfilled,
- removal of infected/infested produce from the consignment,
- imposition of a quarantine period until the results of the examinations or official tests are available,
- refusal of permission to send products to a destination outside the Community,
- destruction.
Article 11(3), second subparagraph, shall apply mutatis mutandis.
In the case of a removal referred to in first subparagraph, second indent, or a refusal referred to in the first subparagraph, fourth indent, the Member States shall lay down that the phytosanitary certificates or the reforwarding phytosanitary certificates produced when the plants, plant products or other objects are submitted for introduction into their territory, be cancelled by the relevant responsible official bodies. Upon cancellation, the said certificate shall bear on its face and in a prominent position a triangular stamp in red, marked "certificate cancelled", from the said responsible bodies showing at least their name and the date of refusal. It shall be in capital letters, and in at least one of the official languages of the Community.
Article 14
The Council acting on a proposal from the Commission, shall adopt any amendments to be made to the Annexes.
However, the following shall be adopted in accordance with the procedure laid down in Article 17:
(a) headings additional to Annex III in respect of certain plants, plant products or other objects originating in specified third countries, provided that:
(i) these headings are introduced at the request of a Member State which already applies special prohibitions as regards the introduction of such products from third countries;
(ii) harmful organisms occurring in the country of origin constitute a plant-health risk for the whole or part of the Community; and
(iii) their possible presence on the products in question cannot be detected effectively at the time of their introduction;
(b) headings additional to the other Annexes in respect of certain plants, plant products or other objects originating in specified third countries, provided that:
(i) these headings are introduced at the request of a Member State which already applies special prohibitions or restrictions as regards the introduction of such products from third countries; and
(ii) harmful organisms occurring in the country of origin constitute a plant-health risk for the whole or part of the Community in respect of crops, the scale of possible damage to which is unforeseeable;
(c) any amendment to Part B of the Annexes, in agreement with the Member State concerned;
(d) any other amendment to the Annexes to be made in the light of developments in scientific or technical knowledge.
Article 15
1. In accordance with the procedure laid down in Article 17, or, in urgent cases, with that laid down in Article 19, Member States may be authorised on request to provide for derogations:
- from Article 4(1) and (2) with regard to Annex III, Part A and Part B, without prejudice to the provisions of Article 4(5), and from Article 5(1) and (2) and the third indent of Article 13(1)(a) with regard to other requirements referred to in Annex IV, Part A, Section I and Annex IV, Part B,
- from Article 7(2) and Article 13(1)(b), in the case of wood, if equivalent safeguards are given,
provided that it is established that the risk of spreading harmful organisms is obviated by one or more of the following factors:
- the origin of the plants or plant products,
- appropriate treatment,
- special precautions for the use of the plants or plant products.
The risk shall be assessed on the basis of available scientific and technical information; where such information is insufficient, it shall be supplemented by additional enquiries or, where appropriate, by investigations carried out under the authority of the Commission and in accordance with the relevant provisions of Article 21 in the country of origin of the plants, plant products or other objects concerned.
Each authorisation shall apply individually to all or part of the territory of the Community under conditions which take into account the risk of spreading harmful organisms by the product in question in protected zones or in certain regions taking into account the differences in agricultural and ecological conditions. In such cases, the Member States concerned shall be expressly exempted from certain obligations derived from the above provisions in the decisions providing for the authorisations.
The risk shall be assessed on the basis of available scientific and technical information. Where such information is insufficient, it shall be supplemented by additional enquiries or, where appropriate, by investigations carried out by the Commission in the country of origin of the plants, plant products or other objects concerned.
2. In the case of the derogations provided for in paragraph 1, an official statement that the conditions for granting the derogation are fulfilled shall be required for each individual case.
3. Member States shall inform the Commission of the derogations which they have granted in accordance with paragraph 1. The Commission shall notify the other Member States of this information each year.
In accordance with the procedure laid down in Article 17, Member States may be exempted from providing this information.
Article 16
1. Each Member State shall immediately notify the Commission and the other Member States of the presence in its territory of any of the harmful organisms listed in Annex I, Part A, Section I or Annex II, Part A, Section I or of the appearance in part of its territory in which their presence was previously unknown of any of the harmful organisms listed in Annex I, Part A, Section II or in Part B or in Annex II, Part A, Section II or in Part B.
It shall take all necessary measures to eradicate, or if that is impossible, inhibit the spread of the harmful organisms concerned. It shall inform the Commission and the other Member States of the measures taken.
2. Each Member State shall immediately notify the Commission and the other Member States of the actual or suspected appearance of any harmful organisms not listed in Annex I or in Annex II whose presence was previously unknown in its territory. It shall also inform the Commission and the other Member States of the protective measures which it has taken or intends to take. These measures must, inter alia, be such as to prevent risk of the spread of the harmful organism concerned in the territory of the other Member States.
In respect of consignments of plants, plant products or other objects from third countries considered to involve an imminent danger of the introduction or spread of the harmful organisms referred to in paragraph 1 and the first subparagraph of this paragraph, the Member State concerned shall immediately take the measures necessary to protect the territory of the Community from that danger and shall inform the Commission and the other Member States thereof.
Where a Member State considers that there is an imminent danger other than that referred to in the second subparagraph, it shall immediately notify the Commission and the other Member States of the measures which it would like to see taken. If it considers that these measures are not being taken in sufficient time to prevent the introduction or spread of a harmful organism in its territory, it may temporarily take any additional measures which it deems necessary, as long as the Commission has not adopted measures pursuant to paragraph 3.
The Commission will present a report to the Council on the operation of this provision, together with any proposals, by 31 December 1992.
3. In cases referred to in paragraphs 1 and 2, the Commission shall examine the situation as soon as possible within the Standing Committee on Plant Health. On-site investigations may be made under the authority of the Commission and in accordance with the relevant provisions of Article 21. The necessary measures may be adopted, including those whereby it may be decided whether measures taken by the Member States should be rescinded or amended, under the procedure laid down in Article 19. The Commission shall follow the development of the situation and, under the same procedure, shall amend or repeal, as that development requires, the said measures. Until a measure has been adopted under the aforesaid procedure, the Member State may maintain the measures that it has employed.
4. The detailed rules for applying paragraphs 1 and 2 shall be adopted, as necessary, in accordance with the procedure laid down in Article 18.
Article 17
1. Where the procedure laid down in this Article is to be followed, the matter shall be referred without delay to the Standing Committee on Plant Health (hereinafter referred to as "the Committee"), by its chairman, either on his own initiative or at the request of a Member State.
2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 205(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.
3. Where the measures are in accordance with the opinion of the Committee, the Commission shall adopt them and shall implement them forthwith. Where the measures are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall immediately submit to the Council a proposal on the measures to be taken. The Council shall adopt the measures by a qualified majority.
If, within three months following the date on which the matter was referred to it, the Council has not adopted measures, the Commission shall adopt the proposed measures and shall implement them immediately, except where the Council has rejected the said measures by a simple majority.
Article 18
1. Where the procedure laid down in this Article is to be followed, the matter shall be referred without delay to the Committee, by its chairman, either on his own initiative or at the request of a Member State.
2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 205(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.
3. Where the measures are in accordance with the opinion of the Committee, the Commission shall adopt them and shall implement them forthwith. Where the measures are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall immediately submit to the Council a proposal on the measures to be taken. The Council shall adopt the measures by a qualified majority.
If, within three months following the date on which the matter was referred to it, the Council has not adopted measures, the Commission shall adopt the proposed measures.
Article 19
1. Where the procedure laid down in this Article is to be followed, the matter shall be referred without delay to the Committee, by its chairman, either on his own initiative or at the request of a Member State.
2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within two days. The opinion shall be delivered by the majority laid down in Article 205(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.
3. Where the measures are in accordance with the opinion of the Committee, the Commission shall adopt them and shall implement them forthwith. Where the measures are not in accordance with the opinion of the Committee or if no opinion is delivered, the Commission shall immediately submit to the Council a proposal on the measures to be taken. The Council shall adopt the measures by a qualified majority.
If, within 15 days following the date on which the matter was referred to it, the Council has not adopted measures, the Commission shall adopt the proposed measures and shall implement them immediately, except where the Council has rejected the said measures by a simple majority.
Article 20
1. This Directive in no way affects Community provisions on plant-health requirements for plants and plant products, except where it provides for or expressly permits stricter requirements in this respect.
2. Amendments to this Directive which are necessary to establish coherence with the Community provisions referred to in paragraph 1 shall be adopted in accordance with the procedure laid down in Article 18.
3. For the introduction into their territory of any plants or plant products, in particular those listed in Annex VI and their packaging or the vehicles transporting them, Member States may take special plant-health measures against the harmful organisms which generally attack plants, or plant products in storage.
Article 21
1. For the purpose of ensuring the correct and uniform application of this Directive, and without prejudice to checks carried out under the authority of the Member States, the Commission may organise checks to be carried out by experts under its authority in respect of the tasks listed in paragraph 3, on- or off-site, in accordance with the provisions of this Article.
Where such checks are carried out in a Member State, this must be done in cooperation with the official plant protection organisation of that Member State as specified in paragraphs 4 and 5 and in accordance with the procedures set out in paragraph 7.
2. The experts referred to in paragraph 1 may be:
- employed by the Commission,
- employed by Member States, and put at the disposal of the Commission on a temporary or ad hoc basis.
They shall have acquired, at least in one Member State, the qualifications required for persons in charge of carrying out and monitoring official plant health inspections.
3. The checks referred to in paragraph 1 may be carried out in respect of the following tasks:
- monitoring examinations pursuant to Article 6,
- monitoring or, within the framework of the provisions laid down in the fifth subparagraph of this paragraph, carrying out in cooperation with the Member States inspections pursuant to Article 13(1),
- carrying out the activities specified in the technical arrangements referred to in Article 13(7),
- making the investigations referred to in Article 15(1) and Article 16(3),
- assisting the Commission in the matters referred to in paragraph 6,
- carrying out any other duty assigned to the experts by the Council, acting by a qualified majority on a proposal from the Commission.
4. For the purpose of the tasks listed in paragraph 3, the experts referred to in paragraph 1 may:
- visit nurseries, farms and other places where plants, plant products or other objects are or were grown, produced, processed or stored,
- visit places where examinations pursuant to Article 6 or inspections pursuant to Article 13 are carried out,
- consult officials of the official plant protection organisations of the Member States,
- accompany the Member States' national inspectors when they carry out activities for the purposes of applying this Directive.
5. Under the cooperation mentioned in paragraph 1, second subparagraph, the official plant protection organisation of that Member State shall be given sufficient advance notice of the task to permit the necessary arrangements to be made.
Member States shall take all reasonable steps to ensure that the objectives and effectiveness of inspections are not jeopardised. They shall ensure that the experts may carry out their tasks without hindrance, and shall take all reasonable steps to provide them, on their request, with the available necessary facilities, including laboratory equipment and laboratory staff. The Commission shall ensure refunding of expenses resulting from such requests, within the limits of appropriations available for that purpose in the general budget of the European Union.
The experts shall, wherever national legislation so requires, be duly mandated by the official plant protection organisation of the Member State concerned and observe the rules and practices imposed on that Member State's officials.
Where the task consists of monitoring the examinations referred to in Article 6, monitoring the inspections referred to in Article 13(1), or making the investigations referred to in Article 15(1) and Article 16(3), no decision may be taken on-site. The experts shall report to the Commission on their activities and their findings.
Where the task consists of carrying out the inspections pursuant to Article 13(1), those inspections shall be integrated in an established inspection programme and the rules of procedure established by the Member State concerned shall be complied with; however, in the case of a joint inspection, the Member State concerned will only allow the introduction of a consignment into the Community if its plant protection organisation and the Commission are in agreement. In accordance with the procedure laid down in Article 18, this condition may be extended to other irrevocable requirements applied to consignments before introduction into the Community if experience shows such extension to be necessary. Should the Community expert and the national inspector fail to agree, the Member State concerned shall take any necessary temporary measures, pending a definitive decision.
In all cases, national provisions in respect of criminal proceedings and administrative penalties shall apply according to the normal procedures. Where the experts identify a suspected infringement of the provisions of this Directive, this shall be notified to the competent authorities of the Member State concerned.
6. The Commission shall:
- establish a network for the notification of new occurrences of harmful organisms,
- make recommendations for drawing up guidelines for the experts and for national inspectors in carrying out their activities.
To assist the Commission in this latter task, Member States shall notify the Commission of the current national inspection procedures in the plant health field.
7. The Commission shall adopt, under the procedure laid down in Article 18, detailed rules for the application of this Article, including those applicable to the cooperation mentioned in paragraph 1, second subparagraph.
8. The Commission shall report to the Council, no later than 31 December 1994, on the experience gained from the implementation of the provisions of this Article. The Council, acting by a qualified majority on a proposal from the Commission, shall take the necessary measures to amend these provisions, if appropriate, in the light of this experience.
Article 22
In the event of the actual or suspected appearance of a harmful organism as a result of its introduction or spread within the Community, Member States may receive a "plant-health control" financial contribution from the Community pursuant to Articles 23 and 24 to cover expenditure relating directly to the necessary measures which have been taken or are planned for the purpose of combating that harmful organism in order to eradicate or, if that is not possible, contain it. The Commission shall propose the entry of suitable appropriations for that purpose in the general budget of the European Union.
Article 23
1. The Member State concerned may receive, at its request, the Community financial contribution referred to in Article 22, where it is established that the harmful organism concerned, whether or not listed in Annexes I and II:
- has been notified under Article 16(1) or (2) first subparagraph, and
- constitutes an imminent danger for all or part of the Community due to its appearance in an area where the organism had either not been known to occur previously or had been or was being eradicated, and
- was introduced into that area through consignments of plants, plant products or other objects from a third country or another area of the Community.
2. The following shall be regarded as necessary measures within the meaning of Article 22:
(a) destruction, disinfection, disinfestation, sterilisation, cleaning or any other treatment carried out officially or upon official request in respect of:
(i) plants, plant products or other objects constituting the consignment(s) through which the harmful organism was introduced into the area in question and which are recognised as being contaminated or liable to be contaminated;
(ii) plants, plant products and other objects, recognised as being contaminated or liable to be contaminated by the harmful organism introduced, which have been grown from plants in the consignment(s) concerned or have been in close proximity to the plants, plant products or other objects of those consignments or to plants grown from them;
(iii) growing substrates and land recognised as being contaminated or liable to be contaminated by the harmful organism concerned;
(iv) production material, packaging, wrapping and storage material, storage or packaging premises and means of transport which have been in contact with all or some of the plants, plant products and other objects referred to above;
(b) inspections or testing carried out officially or upon official request to monitor the presence or extent of contamination by the harmful organism which has been introduced;
(c) prohibitions or restrictions in respect of the use of growing substrates, cultivable areas or premises, as well as plants, plant products or other objects other than material from the consignment(s) in question or grown therefrom where they result from official decisions taken on the grounds of plant-health risks related to the harmful organism introduced.
3. Payments made from public funds in order to:
- cover all or part of the costs of the measures described in paragraph 2(a) and (b), except for those related to the regular running costs of the competent official body concerned, or
- to compensate for all or part of the financial losses other than loss of earnings resulting directly from one or more of the measures described in paragraph 2(c),
shall be considered to be expenditure directly relating to the necessary measures referred to in paragraph 2.
By way of derogation from the second indent of the first subparagraph an implementing Regulation may specify, in accordance with the procedure laid down in Article 18, cases in which compensation for loss of earnings shall be considered to be expenditure directly relating to necessary measures subject to the conditions specified in this respect in paragraph 5 as well as the time limitations applicable to those cases, with a maximum of three years.
4. In order to qualify for the financial contribution from the Community and without prejudice to Article 16, the Member State concerned shall apply to the Commission, at the latest before the end of the calendar year following that in which the appearance of the harmful organism was detected, and shall forthwith inform the Commission and the other Member States of:
- the reference of the notification provided for in the first indent of paragraph 1,
- the nature and extent of the appearance of the harmful organism as referred to in Article 22 and when, where and how it was detected,
- the identity of the consignments referred to in the third indent of paragraph 1 through which the harmful organism was introduced,
- the necessary measures which have been taken or are planned for which it is seeking assistance, together with timetables for them, and
- the results obtained and the actual or estimated cost of the expenditure incurred or to be incurred, and the proportion of such expenditure covered or to be covered from public funds allocated by the Member State for implementation of those same necessary measures.
Where the appearance of the harmful organism was detected prior to 30 January 1997, that date shall be deemed to be the date of detection within the meaning of this paragraph and paragraph 5, provided that the actual date of detection is not earlier than 1 January 1995. However, this provision shall not apply in respect of compensation for loss of earnings referred to in paragraph 3, second subparagraph save in exceptional cases, under the conditions laid down in the implementing Regulation referred to in paragraph 3, to loss of earnings occurring thereafter.
5. Without prejudice to Article 24, the allocation and the amount of the financial contribution from the Community shall be decided in accordance with the procedure laid down in Article 18, in the light of the information and documents submitted by the Member State concerned in accordance with paragraph 4 and, where appropriate, the results of investigations carried out on the Commission's authority by the experts referred to in Article 21 pursuant to the first subparagraph of Article 16(3), taking into account the extent of the danger referred to in the second indent of paragraph 1 above, and depending on the appropriations available for these purposes.
Within the limits set by the appropriations available for these purposes, the financial contribution from the Community shall cover up to 50 % and, in case of compensation for loss of earnings referred to in paragraph 3, second subparagraph, up to 25 %, of expenditure relating directly to the necessary measures referred to in paragraph 2, provided that these measures have been taken within a period not more than two years after the date of detection of the appearance of a harmful organism as referred to in Article 22, or are planned for that period.
The abovementioned period may be extended, in accordance with the same procedure, if examination of the situation concerned leads to the conclusion that the objective of the measures will be achieved within a reasonable additional period. The financial contribution from the Community shall be degressive over the years concerned.
Where a Member State is unable to supply the required information regarding the identity of the consignment in accordance with the third indent of paragraph 4, it shall indicate the presumed sources of the appearance and the reasons why the consignments could not be identified. The allocation of the financial contribution may be approved, in accordance with the same procedure, depending on the outcome of an assessment of that information.
Detailed rules for the implementation of this paragraph shall be established in an implementing Regulation in accordance with the procedure laid down in Article 18.
6. In the light of the development of the situation in the Community, it may be decided, in accordance with the procedure laid down in Article 18 or Article 19, that further action will be implemented or that measures taken or planned by the Member State concerned will be made subject to certain requirements or additional conditions, if these are necessary for the achievement of the objective in question.
The allocation of the financial contribution from the Community for such further action, requirements or conditions shall be decided by the same procedure. Within the limits set by the appropriations available for these purposes, the financial contribution from the Community shall cover up to 50 % of expenditure relating directly to the further action, requirements or conditions concerned.
Where such further action, requirements or conditions are essentially designed to protect Community territories other than that of the Member State concerned, it may be decided, in accordance with the same procedure, that the Community financial allocation shall cover more than 50 % of the expenditure.
The financial contribution from the Community shall be of a limited duration and shall be degressive over the years concerned.
7. The allocation of a financial contribution from the Community shall be without prejudice to claims which the Member State concerned or individuals may have against others, including other Member States in the cases referred to in Article 24(3), for the refunding of expenditure, compensation for losses or other damages under national law, Community law or international law. Rights in these claims will be the object of a transfer, by operation of law, to the Community with effect from the payment of the financial contribution from the Community, to the extent that such expenditure, losses or other damages are covered by that contribution.
8. The financial contribution from the Community may be paid in several instalments.
If it appears that the financial contribution from the Community as allocated is no longer justified, the following shall apply:
The amount of the financial contribution from the Community allocated to the Member State concerned pursuant to paragraphs 5 and 6 may either be reduced or suspended, if it is established from the information supplied by that Member State, or from the results of investigations carried out on the Commission's authority by the experts referred to in Article 21, or from the results of the suitable examination which the Commission has conducted in accordance with the procedures analogous to those in Article 39 of Council Regulation (EC) No 1260/1999 of 21 June 1999 laying down general provisions on the Structural Funds(9) that:
- failure to implement the necessary measures decided on in accordance with paragraphs 5 and 6, whether in whole or in part, or failure to comply with the rules or time limits set in accordance with those provisions or required by the objectives pursued is not justified, or
- the measures are no longer necessary, or
- a situation as described in Article 39 of Regulation (EC) No 1260/1999 is revealed.
9. Articles 8 and 9 of Council Regulation (EC) No 1258/1999 of 17 May 1999 on the financing of the common agricultural policy(10), shall apply mutatis mutandis.
10. The Member State concerned shall repay the Community all or part of any amounts paid it by way of a Community financial contribution allocated under paragraphs 5 and 6 above if it is established from the sources as specified in paragraph 8, that
(a) the necessary measures taken into account pursuant to paragraphs 5 or 6
(i) have not been implemented; or
(ii) have not been implemented in a manner which complies with the rules or time limits set in accordance with those provisions or required by the objectives pursued;
or
(b) the amounts paid have been used for purposes other than those for which the financial contribution was allocated;
or
(c) a situation as described in Article 39 of Regulation (EC) No 1260/1999 is revealed.
The rights referred to the second sentence of paragraph 7 will be the object of a transfer by operation of law back to the Member State concerned with effect from the time of repayment, inasmuch as they are covered by that repayment.
Interest on account of late payment shall be charged on sums not repaid in compliance with the provisions of the Financial Regulation and in accordance with the arrangements to be drawn up by the Commission in accordance with the procedure laid down in Article 18.
Article 24
1. In respect of the causes for the appearance of the harmful organism referred to in Article 22, the following shall apply:
The Commission shall verify whether the appearance of the harmful organism in the area concerned was caused by the movement into that area of one or more consignments carrying the harmful organism and shall identify the Member State or the successive Member States from which the consignment(s) came.
The Member State from which the consignment(s) carrying the harmful organism came, whether or not the same Member State as that referred to above, shall forthwith inform the Commission, at the latter's request, of all details relating to the origin or origins of the consignment(s) and the administrative handling involved, including the examinations, inspections and controls provided for in this Directive, in order to determine why that Member State failed to detect that the consignment(s) did not comply with the provisions of this Directive. It shall also inform the Commission, at its request, of the destination of all the other consignments sent from the same origin or origins during a specified period.
For the purpose of supplementing the information, investigations may be carried out on the Commissions's authority by the experts referred to in Article 21.
2. The information acquired pursuant to these provisions or those of Article 16(3) shall be examined in the Committee for the purposes of identifying any failings in the Community's plant health regulations or their implementation, and any measures that could be taken to remedy those failings.
The information referred to in paragraph 1 shall also be used to establish, in accordance with the Treaty, whether the Member State from which the consignment(s) came did not detect their non-compliance which resulted in the appearance of the harmful organism in the area concerned because that Member State failed to meet one of its obligations under the Treaty and under the provisions of this Directive relating in particular to the examinations laid down in Article 6 or the inspections laid down in Article 13(1).
3. Where the conclusions referred to in paragraph 2 is reached in respect of the Member State referred to in Article 23(1), the Community financial contribution shall not be allocated, or if already allocated shall not be paid or, if already paid, shall be refunded to the Community. In the latter case, the third subparagraph of Article 23(10) shall apply.
Where the conclusion referred to in paragraph 2 is reached in respect of another Member State, Community law shall apply, taking into account the second sentence of Article 23(7).
Article 25
As regards the financial contribution referred to in Article 13(9), the Council, acting by qualified majority on a proposal from the Commission, shall adopt provisions in respect of the exceptional cases of predominant Community interest justifying a Community contribution, up to 70 %, of the expenditure relating directly to improving equipment and facilities, within the limits set by appropriations available for those purposes and provided that this would not affect decisions pursuant to Article 23(5) or (6).
Article 26
By 20 January 2002 at the latest, the Commission shall examine the results of the application of Article 13(9) and Articles 22, 23 and 24 and submit to the Council a report, accompanied by any necessary proposals for amendments.
Article 27
Directive 77/93/EEC as amended by the acts listed in Annex VIII, Part A is hereby repealed without prejudice to the obligations of the Member States concerning the time limits for transposition and application set out in Annex VIII, Part B.
References to the repealed Directive shall be construed as references to this Directive and should be read in accordance with the correlation table in Annex IX.
Article 28
This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.
Article 29
This Directive is addressed to the Member States.
|
[
"UKSI20012342",
"UKSI19931320"
] |
32000L0014
|
2000
|
Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),
Whereas:
(1) Within the framework of the internal market, requirements for the noise emission by equipment for use outdoors have to be harmonised in order to prevent obstacles to the free movement of such equipment. Reducing permissible noise levels for such equipment will protect the health and well-being of citizens as well as protect the environment. The public should also be provided with information on the noise emitted by such equipment.
(2) Community legislation concerning noise emission by equipment for use outdoors has consisted to date of the following nine directives covering some types of construction machinery and lawnmowers: Council Directive 79/113/EEC of 19 December 1978 on the approximation of the laws of the Members States relating to the determination of the noise emission of construction plant and equipment(4), Council Directive 84/532/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to common provisions for construction plant and equipment(5), Council Directive 84/533/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to the permissible sound power lever of compressors(6), Council Directive 84/534/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to the permissible sound power level of tower cranes(7), Council Directive 84/535/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to the permissible sound power level of welding generators(8), Council Directive 84/536/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to the permissible sound power level of power generators(9), Council Directive 84/537/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to the permissible sound power level of powered hand-held concrete-breakers and picks(10), Council Directive 84/538/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to the permissible sound power level of lawnmowers(11) and Council Directive 86/662/EEC of 22 December 1986 on the limitation of noise emitted by hydraulic excavators, rope-operated excavators, dozers, loaders and excavator-loaders(12), hereinafter referred to as "existing Directives"; these Directives lay down the requirements with regard to permissible noise levels, noise test codes, marking and conformity assessment procedures for each type of equipment separately. A simplification of this legislation and the creation of a framework for the reduction of noise emission by equipment for use outdoors is appropriate.
(3) This Directive is based on the principles and concepts set out in the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards(13). The aforementioned principles have been further developed in the Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedure and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives(14).
(4) The Fifth Environmental Action Programme attached to the resolution of 1 February 1993(15) identifies noise as one of the most pressing environmental problems in urban areas and the need to take action with regard to various noise sources.
(5) In its Green Paper "Future Noise Policy", the Commission addressed noise in the environment as one of the main local environmental problems in Europe, and announced its intention to propose a framework directive to control noise emission by equipment for use outdoors.
(6) Member States should ensure that equipment covered by this Directive complies with the requirements thereof when placed on the market or put into service in the Member States. Requirements protecting workers by regulating the use of outdoor equipment are not affected by this Directive.
(7) Member States should not prohibit, restrict or impede the placing on the market or putting into service in their territory of equipment which complies with the requirements of this Directive, bears the CE marking and the indication of the guaranteed sound power level and is accompanied by an EC declaration of conformity.
(8) The manufacturer or his authorised representative established in the Community should be responsible for ensuring that the equipment is in conformity with the provisions of this Directive and of any other directives that apply to it. The manufacturer or his authorised representative established in the Community should affix the CE marking and the indication of the guaranteed sound power level to the equipment and ensure that the equipment is accompanied by an EC declaration of conformity in order to certify thereby that the equipment is in conformity with the provisions of this Directive and any other pertinent directives.
(9) Member States, if necessary in cooperation with other Member States, should take all appropriate measures to ensure that non-complying equipment will comply in future or is withdrawn from the market. A sound implementation and application of this Directive is indispensable to meet the objectives of this Directive. A closer cooperation in the market surveillance by means of a continuous exchange of information is necessary. Therefore a Committee should be established.
(10) Marking of equipment for use outdoors with its guaranteed sound power level is essential in order to enable consumers and users to make an informed choice of equipment and as a basis for regulation on use or economic instruments to be adopted at the local or national level. This marking must be clear and unambiguous. The indicated values should be guaranteed by the manufacturer. It is appropriate that the indication of the noise emission in the form of the guaranteed sound power level should accompany the CE marking. A unified, fixed procedure to assess noise emission values is an indispensable condition for reliable marking.
(11) Existing directives concerning compressors, tower cranes, welding and power generators, and concrete-breakers and picks require the Commission to submit proposals to reduce the permissible noise levels. Noise reduction technology for some other equipment for use outdoors (e.g. graders, loader-type landfill compactors, dumpers, combustion-engine driven counterbalanced lift trucks, mobile cranes, builders' hoists, construction winches, compaction machines, paver-finishers and hydraulic power packs) is available but not generally used. Surveys show that the noise emission values of equipment for use outdoors of the same power currently on the market can differ by more than 10 dB. It is appropriate to reduce noise emissions by equipment subject to noise limits down to the level of the better performers on the market today in two stages, in order to allow manufacturers who do not already comply with the requirements sufficient time to adapt their equipment to the more demanding limit values.
(12) Different conformity assessment procedures may be considered appropriate for different categories of equipment. Decision 93/465/EEC offers different modules for use in conformity assessment procedures. For equipment subject to permissible sound power levels, a procedure consisting of an involvement of a notified body for checking the conformity with the provisions of this Directive in the design and the production phase is considered to be appropriate. Self certification is considered appropriate for equipment subject to noise marking only. Monitoring is indispensable.
(13) The technical and administrative standards of notified bodies throughout the Community should be the same. This can only be achieved by setting minimum criteria they have to meet.
(14) The collection of noise data is considered to be indispensable as a basis for informed consumer choice and for the Member States' and the Commission's further assessment of new technological development and the need for further legislative action. These noise data can be collected by simply sending a copy of the EC declaration of conformity to the Member State and the Commission.
(15) In order to protect citizens against unreasonably high noise exposure, Member States should be able to restrict, in accordance with the provisions of the Treaty, the use of equipment in the environment.
(16) The technical provisions concerning the measurement methods must be supplemented and adapted as necessary to technical progress and the progress in European standardisation. The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(16).
(17) It is important to have lower noise emission limits for lawnmowers and lawn trimmers/lawn edge trimmers which have remained unchanged since the adoption of Directive 84/538/EEC. To give guidance to industry, indicative figures for lower limits should be introduced for stage II. The Commission should submit a report to the European Parliament and the Council on whether and to what extent technical progress allows a reduction of limit values for lawnmowers and lawn trimmers/lawn edge trimmers, and, if appropriate, submit a proposal to amend this Directive.
(18) This Directive replaces the existing directives; the existing directives must be repealed when the requirements of this Directive come into force. Transitional periods are necessary to allow a smooth transition from the existing directives to this Directive,
Article 1
Objectives
The aim of this Directive is to harmonise the laws of the Member States relating to noise emission standards, conformity assessment procedures, marking, technical documentation and collection of data concerning the noise emission in the environment of equipment for use outdoors. It will contribute to the smooth functioning of the internal market, while protecting human health and well-being.
Article 2
Scope
1. This Directive applies to equipment for use outdoors listed in Articles 12 and 13 and defined in Annex I. This Directive only covers equipment that is placed on the market or put into service as an entire unit suitable for the intended use. Non-powered attachments that are separately placed on the market or put into service shall be excluded, except for hand-held concrete-breakers and picks and for hydraulic hammers.
2. The following shall be excluded from the scope of this Directive:
- all equipment primarily intended for the transport of goods or persons by road or rail or by air or on waterways,
- equipment specially designed and constructed for military and police purposes and for emergency services.
Article 3
Definitions
For the purpose of this Directive the following definitions shall apply:
(a) "equipment for use outdoors" means all machinery defined in Article 1(2) of Directive 98/37/EC of the European Parliament and of the Council of 22 June 1998 on the approximation of the laws of the Member States relating to machinery(17) which is either self-propelled or can be moved and which, irrespective of the driving element(s), is intended to be used, according to its type, in the open air and which contributes to environmental noise exposure. The use of equipment in an ambience where the transmission of sound is not or not significantly affected (for instance under tents, under roofs for protection against rain or in the shell of houses) is regarded as use in the open air. It also means non-powered equipment for industrial or environmental applications which is intended, according to its type, to be used outdoors and which contributes to environmental noise exposure. All these types of equipment are hereinafter referred to as "equipment";
(b) "conformity assessment procedures" means the procedures laid down in Annexes V to VIII, based on Decision 93/465/EEC;
(c) "marking" means the visibly, legibly and indelibly affixing on the equipment of the CE marking defined in Decision 93/465/EEC accompanied by the indication of the guaranteed sound power level;
(d) "sound power level LWA" means the A-weighted sound power in dB in relation to 1 pW as defined in EN ISO 3744:1995 and EN ISO 3746:1995;
(e) "measured sound power level" means a sound power level as determined from measurements as laid down in Annex III; measured values may be determined either from a single machine representative for the type of equipment or from the average of a number of machines;
(f) "guaranteed sound power level" means a sound power level determined in accordance with the requirements laid down in Annex III which includes the uncertainties due to production variation and measurement procedures and where the manufacturer, or his authorised representative established in the Community, confirms that according to the technical instruments applied and referred to in the technical documentation it is not exceeded.
Article 4
Placing on the market
1. Equipment referred to in Article 2(1) shall not be placed on the market or put into service until the manufacturer, or his authorised representative established in the Community, ensures that:
- the equipment satisfies the requirements concerning the noise emission in the environment of this Directive,
- the conformity assessment procedures referred to in Article 14 have been completed,
- the equipment bears CE marking and the indication of the guaranteed sound power level and is accompanied by an EC declaration of conformity.
2. Where neither the manufacturer nor his authorised representative is established in the Community, the obligations of this Directive shall apply to any person placing the equipment on the market or putting it into service in the Community.
Article 5
Market surveillance
1. Member States shall take appropriate measures to ensure that equipment referred to in Article 2(1) may be placed on the market or put into service only if it conforms to the provisions of this Directive, bears the CE marking and the indication of the guaranteed sound power level and is accompanied by an EC declaration of conformity.
2. The competent authorities of the Member States shall assist each other in fulfilment of their obligations to carry out market surveillance.
Article 6
Free movement
1. Member States shall not prohibit, restrict or impede the placing on the market or putting into service in their territory of equipment referred to in Article 2(1) which complies with the provisions of this Directive, bears the CE marking and the indication of the guaranteed sound power level and is accompanied by an EC declaration of conformity.
2. At trade fairs, exhibitions, demonstrations, and similar events, Member States shall not prevent the showing of equipment referred to in Article 2(1) which does not conform to the provisions of this Directive, provided that a visible sign clearly indicates that such equipment does not conform and that it is not placed on the market or put into service until it has been brought into conformity by the manufacturer or his authorised representative established in the Community. During demonstrations adequate safety measures shall be taken to ensure the protection of persons.
Article 7
Presumption of conformity
Member States shall presume that equipment referred to in Article 2(1) bearing the CE marking and the indication of the guaranteed sound power level and which is accompanied by the EC declaration of conformity conforms to all the provisions of this Directive.
Article 8
EC Declaration of conformity
1. The manufacturer, or his authorised representative established in the Community, of equipment referred to in Article 2(1) shall, in order to certify that an item of equipment is in conformity with the provisions of this Directive, draw up an EC declaration of conformity for each type of equipment manufactured; the minimum content of this declaration of conformity is laid down in Annex II.
2. A Member State may require that the declaration of conformity be drawn up in or translated into the official Community language or languages determined by the Member State when equipment is placed on the market or put into service in its territory.
3. The manufacturer, or his authorised representative established in the Community, of equipment referred to in Article 2(1) shall keep a specimen of the EC declaration of conformity for 10 years from the date on which the equipment was last manufactured, together with the technical documentation as provided for in Annex V point 3, Annex VI point 3, Annex VII point 2, Annex VIII points 3.1 and 3.3.
Article 9
Non-compliance of equipment
1. Where a Member State ascertains that equipment referred to in Article 2(1) which is placed on the market or put into service does not comply with the requirements of this Directive, it shall take all appropriate measures so that the manufacturer or his authorised representative established in the Community shall bring the equipment into conformity with the provisions of this Directive.
2. Where
(a) the limit values referred to in Article 12 are exceeded; or
(b) non-compliance with other provisions of this Directive continues despite measures taken under paragraph 1;
the Member State concerned shall take all appropriate measures to restrict or prohibit the placing on the market or putting into service of the equipment in question or to ensure that it is withdrawn from the market. The Member State shall immediately inform the Commission and the other Member States of such measures.
3. The Commission shall enter into consultations with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that:
- the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States,
- the measures are unjustified, it shall immediately so inform the Member State which took the initiative, the other Member States and the manufacturer or his authorised representative established in the Community.
4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.
Article 10
Legal remedies
Any measure taken by a Member State pursuant to this Directive which restricts the placing on the market or putting into service of equipment covered by this Directive shall state the exact reasons on which it is based. Such a measure taken shall be notified as soon as possible to the party concerned, who shall at the same time be informed of the legal remedies available to him under the laws in force in the Member State concerned and of the time limits to which such remedies are subject.
Article 11
Marking
1. Equipment referred to in Article 2(1) placed on the market or put into service which complies with the provisions of this Directive shall bear the CE marking of conformity. The marking shall consist of the initials "CE". The form of the marking to be used is shown in Annex IV.
2. The CE marking shall be accompanied by the indication of the guaranteed sound power level. A model of this indication is given in Annex IV.
3. The CE marking of conformity and the indication of the guaranteed sound power level shall be affixed in a visible, legible and indelible form to each item of equipment.
4. The affixing of markings or inscriptions on the equipment which are likely to be misleading with regard to the meaning or the CE marking or to the indication of the guaranteed sound power level shall be prohibited. Any other marking may be affixed to the equipment, provided that the visibility and legibility of the CE marking and the indication of the guaranteed sound power level is not thereby reduced.
5. Where the equipment referred to in Article 2(1) is subject to other directives concerning other aspects and which also provide for the affixing of the CE marking, the marking shall indicate that such equipment also fulfils the provisions of those directives. However, should one or more of these directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the equipment only fulfils the provisions of the directives applied by the manufacturer. In this case the particulars of those directives, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by those directives and accompanying such equipment.
Article 12
Equipment subject to noise limits
The guaranteed sound power level of equipment listed below shall not exceed the permissible sound power level as laid down in the following tables of limit values:
- builders' hoists for the transport of goods (combustion-engine driven)
Definition:
Annex I, item 3. Measurement: Annex III, Part B, item 3
- compaction machines (only vibrating and non-vibrating rollers, vibratory plates and vibratory rammers)
Definition:
Annex I, item 8. Measurement: Annex III, Part B, item 8
- compressors (< 350 kW)
Definition:
Annex I, item 9. Measurement: Annex III, Part B, item 9
- concrete-breakers and picks, hand-held
Definition:
Annex I, item 10. Measurement: Annex III, Part B, item 10
- construction winches (combustion-engine driven)
Definition:
Annex I, item 12. Measurement: Annex III, Part B, item 12
- dozers (< 500 kW)
Definition:
Annex I, item 16. Measurement: Annex III, Part B, item 16
- dumpers (< 500 kW)
Definition:
Annex I, item 18. Measurement: Annex III, Part B, item 18
- excavators, hydraulic or rope-operated (< 500 kW)
Definition:
Annex I, item 20. Measurement: Annex III, Part B, item 20
- excavator-loaders (< 500 kW)
Definition:
Annex I, item 21. Measurement: Annex III, Part B, item 21
- graders (< 500 kW)
Definition:
Annex I, item 23. Measurement: Annex III, Part B, item 23
- hydraulic power packs
Definition:
Annex I, item 29. Measurement: Annex III, Part B, item 29
- landfill compactors, loader-type with bucket (< 500 kW)
Definition:
Annex I, item 31. Measurement: Annex III, Part B, item 31
- lawnmowers (excluding agricultural and forestry equipment, and multi-purpose devices, the main motorised component of which has an installed power of more than 20 kW))
Definition:
Annex I, item 32. Measurement: Annex III, Part B, item 32
- lawn trimmers/lawn edge trimmers
Definition:
Annex I, item 33; Measurement: Annex III, Part B, item 33
- lift trucks, combustion-engine driven, counterbalanced (excluding "other counterbalanced lift trucks" as defined in Annex I, item 36, second indent with a rated capacity of not more than 10 tonnes)
Definition:
Annex I, item 36. Measurement: Annex III, Part B, item 36
- loaders (< 500 kW)
Definition:
Annex I, item 37. Measurement: Annex III, Part B, item 37
- mobile cranes
Definition:
Annex I, item 38. Measurement: Annex III, Part B, item 38
- motor hoes (< 3 kW)
Definition:
Annex I, item 40. Measurement: Annex III, Part B, item 40
- paver-finishers (excluding paver-finishers equipped with a high-compaction screed)
Definition:
Annex I, item 41. Measurement: Annex III, Part B, item 41
- power generators (< 400 kW)
Definition
Annex I, item 45. Measurement: Annex III, Part B, item 45
- tower cranes
Definition:
Annex I, item 53. Measurement: Annex III, Part B, item 53
- welding generators
Definition:
Annex I, item 57. Measurement: Annex III, Part B, item 57.
>TABLE>
Article 13
Equipment subject to noise marking only
The guaranteed sound power level of equipment listed below shall be subject to noise marking only:
- aerial access platforms with combustion engine
Definition:
Annex I, item 1. Measurement: Annex III, Part B, item 1
- brush cutters
Definition:
Annex I, item 2; Measurement: Annex III, Part B, item 2
- builders' hoists for the transport of goods (with electric motor)
Definition:
Annex I, item 3. Measurement: Annex III, Part B, item 3
- building site band saw machines
Definition:
Annex I, item 4. Measurement: Annex III, Part B, item 4
- building site circular saw benches
Definition:
Annex I, item 5. Measurement: Annex III, Part B, item 5
- chain saws, portable
Definition:
Annex I, item 6. Measurement: Annex III, Part B, item 6
- combined high pressure flushers and suction vehicles
Definition:
Annex I, item 7. Measurement: Annex III, Part B, item 7
- compaction machines (explosion rammers only)
Definition:
Annex I, item 8. Measurement: Annex III, Part B, item 8
- concrete or mortar mixers
Definition:
Annex I, item 11. Measurement: Annex III, Part B, item 11
- construction winches (with electric motor)
Definition:
Annex I, item 12. Measurement: Annex III, Part B, item 12
- conveying and spraying machines for concrete and mortar
Definition:
Annex I, item 13. Measurement: Annex III, Part B, item 13
- conveyor belts
Definition:
Annex I, item 14. Measurement: Annex III, Part B, item 14
- cooling equipment on vehicles
Definition:
Annex I, item 15. Measurement: Annex III, Part B, item 15
- drill rigs
Definition:
Annex I, item 17. Measurement: Annex III, Part B, item 17
- equipment for loading and unloading silos or tanks on trucks
Definition:
Annex I, item 19. Measurement: Annex III, Part B, item 19
- glass recycling containers
Definition:
Annex I, item 22. Measurement: Annex III, Part B, item 22
- grass trimmers/grass edge trimmers
Definition:
Annex I, item 24. Measurement: Annex III, Part B, item 24
- hedge trimmers
Definition:
Annex I, item 25. Measurement: Annex III, Part B, item 25
- high pressure flushers
Definition:
Annex I, item 26. Measurement: Annex III, Part B, item 26
- high pressure water jet machines
Definition:
Annex I, item 27. Measurement: Annex III, Part B, item 27
- hydraulic hammers
Definition:
Annex I, item 28. Measurement: Annex III, Part B, item 28
- joint cutters
Definition:
Annex I, item 30. Measurement: Annex III, Part B, item 30
- leaf blowers
Definition:
Annex I, item 34. Measurement: Annex III, Part B, item 34
- leaf collectors
Definition:
Annex I, item 35. Measurement: Annex III, Part B, item 35
- lift trucks, combustion-engine driven, couterbalanced (only "other counterbalanced lift trucks" as defined in Annex I, item 36, second indent, with a rated capacity of not more than 10 tonnes)
Definition:
Annex I, item 36. Measurement: Annex III, Part B, item 36
- mobile waste containers
Definition:
Annex I, item 39. Measurement: Annex III, Part B, item 39
- paver-finishers (equipped with a high-compaction screed)
Definition:
Annex I, item 41. Measurement: Annex III, Part B, item 41
- piling equipment
Definition:
Annex I, item 42. Measurement: Annex III, Part B, item 42
- pipelayers
Definition:
Annex I, item 43. Measurement: Annex III, Part B, item 43
- piste caterpillars
Definition:
Annex I, item 44. Measurement: Annex III, Part B, item 44
- power generators (>= 400 kW)
Definition:
Annex I, item 45. Measurement: Annex III, Part B, item 45
- power sweepers
Definition:
Annex I, item 46. Measurement: Annex III, Part B, item 46
- refuse collection vehicles
Definition:
Annex I, item 47. Measurement: Annex III, Part B, item 47
- road milling machines
Definition:
Annex I, item 48. Measurement: Annex III, Part B, item 48
- scarifiers
Definition:
Annex I, item 49. Measurement: Annex III, Part B, item 49
- shredders/chippers
Definition:
Annex I, item 50. Measurement: Annex III, Part B, item 50
- snow-removing machines with rotating tools (self-propelled, excluding attachments)
Definition:
Annex I, item 51. Measurement: Annex III, Part B, item 51
- suction vehicles
Definition:
Annex I, item 52. Measurement: Annex III, Part B, item 52
- trenchers
Definition:
Annex I, item 54. Measurement: Annex III, Part B, item 54
- truck mixers
Definition:
Annex I, item 55. Measurement: Annex III, Part B, item 55
- water pump units (not for use under water)
Definition:
Annex I, item 56. Measurement: Annex III, Part B, item 56.
Article 14
Conformity assessment
1. Before placing on the market or putting into service any equipment referred to in Article 12 the manufacturer, or his authorised representative established in the Community, shall subject each type of equipment to one of the following conformity assessment procedures:
- the internal control of production with assessment of technical documentation and periodical checking procedure referred to in Annex VI, or
- the unit verification procedure referred to in Annex VII, or
- the full quality assurance procedure referred to in Annex VIII.
2. Before placing on the market or putting into service any equipment referred to in Article 13 the manufacturer, or his authorised representative established in the Community, shall subject each type of equipment to the internal control of production procedure referred to in Annex V.
3. Member States shall ensure that the Commission and any other Member State may, on a reasoned request, obtain all information used during the conformity assessment procedure concerning a type of equipment and in particular the technical documentation provided for in Annex V item 3, Annex VI item 3, Annex VII item 2, Annex VIII items 3.1 an 3.3.
Article 15
Notified bodies
1. Member States shall appoint bodies under their jurisdiction to carry out or supervise the conformity assessment procedures referred to in Article 14(1).
2. Member States shall appoint only such bodies which comply with the criteria set out in Annex IX. The fact that a body complies with the criteria of Annex IX to this Directive does not mean that a Member State is obliged to appoint that body.
3. Each Member State shall notify the Commission and the other Member States of the bodies which they have appointed, together with the specific tasks and examination procedures which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission.
4. The Commission shall publish a list of the notified bodies in the Official Journal of the European Communities along with their identification numbers and the tasks for which they have been appointed. The Commission shall ensure that the list is kept up to date.
5. A Member State must withdraw its notification if it finds that the body no longer meets the criteria referred to in Annex IX. It shall forthwith inform the Commission and the other Member States accordingly.
Article 16
Collection of noise data
1. Member States shall take the measures necessary to ensure that the manufacturer, or his authorised representative established in the Community, shall send to the responsible authority of the Member State where he resides or where he places on the market or puts into service the equipment referred to in Article 2(1) and to the Commission a copy of the EC declaration of conformity for each type of equipment referred to in Article 2(1).
2. The Commission shall collect the data made available in accordance with paragraph 1 for all equipment.
3. Member States may, on request, obtain the collected data from the Commission.
4. The Commission shall publish the relevant information periodically, preferably annually. These publications shall at least contain the following data for each type or model of equipment:
- the net installed power or any other noise related value
- the measured sound power level
- the guaranteed sound power level
- equipment description
- manufacturer and/or brand name
- model number/name
Article 17
Regulation of use
The provisions of this Directive shall not prevent Member States' entitlement to lay down, in due observance of the Treaty:
- measures to regulate the use of equipment referred to in Article 2(1) in areas which they consider sensitive, including the possibility of restricting the working hours of the equipment,
- such requirements as they may deem necessary to ensure that persons are protected when using the equipment in question, provided that this does not mean that the equipment is modified in a way not specified in this Directive.
Article 18
Committee
1. The Commission shall be assisted by a Committee.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The Committee shall adopt its rules of procedure.
Article 19
Committee powers
The Committee shall:
(a) exchange information and experiences concerning the implementation and practical application of this Directive and discuss matters of common interest in those fields;
(b) assist the Commission in the adaptation to technical progress of Annex III in accordance with the regulatory procedure set out in Article 18(2), by means of necessary amendments, provided they do not have any direct impact on the measured sound power level of equipment listed in Article 12, in particular through the inclusion of references to relevant European standards;
(c) provide advice to the Commission with respect to the conclusions and amendments referred to in Article 20(2).
Article 20
Reports
1. Not later than 3 January 2005 and every four years thereafter, the Commission shall submit to the European Parliament and to the Council a report concerning the Commission's experience in the implementation and administration of this Directive. The report shall in particular contain:
(a) a review of the noise data collected in accordance with Article 16 and other appropriate information;
(b) a statement of the need for revision of the lists in Articles 12 and 13, especially whether new equipment should be added in either Article 12 or Article 13 or equipment should be transferred from Article 13 to Article 12;
(c) a statement of the need and the possibilities for revision of the limit values laid down in Article 12 taking into account technological development;
(d) a statement setting out an integrated range of instruments to be used in continuing the reduction of noise by equipment.
2. After having held all the necessary consultations, in particular with the Committee, the Commission shall on that occasion present its conclusions and where appropriate any amendment to this Directive.
3. Not later than 3 July 2002 the Commission shall submit to the European Parliament and to the Council a report concerning whether and to what extent technical progress allows a reduction of limit values for lawnmowers and lawn trimmers/lawn edge trimmers, and, if appropriate, a proposal to amend this Directive.
Article 21
Repeal
1. Directives 79/113/EEC, 84/532/EEC, 84/533/EEC, 84/534/EEC, 84/535/EEC, 84/536/EEC, 84/537/EEC, 84/538/EEC and 86/662/EEC shall be repealed on 3 January 2002.
2. Type-examination certificates issued and measurements of equipment carried out under the Directives mentioned in paragraph 1 may be used in drawing up the technical documentation provided for in Annex V point 3, Annex VI point 3, Annex VII point 2, Annex VIII points 3.1 and 3.3 of this Directive.
Article 22
Transposition and date of application
1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive no later than 3 July 2001. They shall forthwith inform the Commission thereof.
2. Member States shall apply these measures with effect from 3 January 2002. However, Member States shall allow the manufacturer, or his authorised representative established in the Community, to avail himself of the provisions of this Directive as from 3 July 2001.
3. With regard to the reduced permissible sound power levels of stage II referred to in Article 12, these provisions shall apply with effect from 3 January 2006.
4. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
5. Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.
Article 23
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 24
Addressees of the Directive
This Directive is addressed to the Member States.
|
[
"UKSI20013958",
"UKSI20011701"
] |
32000L0026
|
2000
|
Directive 2000/26/EC of the European Parliament and of the Council of 16 May 2000 on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles and amending Council Directives 73/239/EEC and 88/357/EEC (Fourth motor insurance Directive)
Having regard to the Treaty establishing the European Community, and in particular Articles 47(2) and 95 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), in the light of the joint text approved by the Conciliation Committee on 7 April 2000,
Whereas:
(1) At present, differences exist between provisions laid down by law, regulation or administrative action in the Member States relating to insurance against civil liability in respect of the use of motor vehicles and those differences constitute an obstacle to the free movement of persons and of insurance services.
(2) It is therefore necessary to approximate those provisions in order to promote the sound functioning of the single market.
(3) By Directive 72/166/EEC(4), the Council adopted provisions on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles, and to the enforcement of the obligation to insure against such liability.
(4) By Directive 88/357/EEC(5), the Council adopted provisions on the coordination of laws, regulations and administrative provisions relating to direct insurance other than life assurance and laying down provisions to facilitate the effective exercise of freedom to provide services.
(5) The green card bureau system ensures the ready settlement of claims in the injured party's own country even where the other party comes from a different European country.
(6) The green card bureau system does not solve all problems of an injured party having to claim in another country against a party resident there and an insurance undertaking authorised there (foreign legal system, foreign language, unfamiliar settlement procedures and often unreasonably delayed settlement).
(7) By its Resolution of 26 October 1995 on the settlement of claims arising from traffic accidents occurring outside the claimant's country of origin(6), the European Parliament, acting under the second paragraph of Article 192 of the Treaty, called on the Commission to submit a proposal for a European Parliament and Council Directive to solve these problems.
(8) It is in fact appropriate to supplement the arrangements established by Directives 72/166/EEC, 84/5/EEC(7) and 90/232/EEC(8) in order to guarantee injured parties suffering loss or injury as a result of a motor vehicle accident comparable treatment irrespective of where in the Community accidents occur; for accidents falling within the scope of this Directive occurring in a State other than that of the injured party's residence, there are gaps with regard to the settlement of injured parties' claims.
(9) The application of this Directive to accidents occurring in third countries covered by the green card system, affecting injured parties resident in the Community and involving vehicles insured and normally based in a Member State does not imply an extension of the compulsory territorial coverage of motor insurance as provided for in Article 3(2) of Directive 72/166/EEC.
(10) This entails giving the injured party a direct right of action against the insurance undertaking of the responsible party.
(11) One satisfactory solution might be for injured parties suffering loss or injury as a result of a motor vehicle accident falling within the scope of this Directive and occurring in a State other than that of their residence to be entitled to claim in their Member State of residence against a claims representative appointed there by the insurance undertaking of the responsible party.
(12) This solution would enable damage suffered by injured parties outside their Member State of residence to be dealt with by procedures familiar to them.
(13) This system of having claims representatives in the injured party's Member State of residence affects neither the substantive law to be applied in each individual case nor the matter of jurisdiction.
(14) The existence of a direct right of action against the insurance undertaking for the party who has suffered loss or injury is a logical supplement to the appointment of such representatives and moreover improves the legal position of injured parties of motor vehicle accidents occurring outside that party's Member State of residence.
(15) In order to fill the gaps in question, it should be provided that the Member State where the insurance undertaking is authorised should require the undertaking to appoint claims representatives resident or established in the other Member States to collect all necessary information in relation to claims resulting from such accidents and to take appropriate action to settle the claims on behalf and for the account of the insurance undertaking, including the payment of compensation therefor; claims representatives should have sufficient powers to represent the insurance undertaking in relation to persons suffering damage from such accidents, and also to represent the insurance undertaking before national authorities including, where necessary, before the courts, in so far as this is compatible with the rules of private international law on the conferral of jurisdiction.
(16) The activities of the claims representative are not sufficient in order to confer jurisdiction on the courts in the injured party's Member State of residence if the rules of private international law on the conferral of jurisdiction do not so provide.
(17) The appointment of representatives responsible for settling claims should be one of the conditions for access to and carrying on the activity of insurance listed in class 10 of point A of the Annex to Directive 73/239/EEC(9), except for carriers' liability; that condition should therefore be covered by the single official authorisation issued by the authorities of the Member State where the insurance undertaking establishes its head office, as specified in Title II of Directive 92/49/EEC(10); that condition should also apply to insurance undertakings having their head office outside the Community which have secured an authorisation granting them access to the activity of insurance in a Member State of the Community; Directive 73/239/EEC should be amended and supplemented accordingly.
(18) In addition to ensuring that the insurance undertaking has a representative in the State where the injured party resides, it is appropriate to guarantee the specific right of the injured party to have the claim settled promptly; it is therefore necessary to include in national law appropriate effective and systematic financial or equivalent administrative penalties - such as injunctions combined with administrative fines, reporting to supervisory authorities on a regular basis, on-the-spot checks, publications in the national official journal and in the press, suspension of the activities of the company (prohibition on the conclusion of new contracts for a certain period), designation of a special representative of the supervisory authorities responsible for monitoring that the business is run in line with insurance laws, withdrawal of the authorisation for this business line, sanctions to be imposed on directors and management staff - in the event that the insurance undertaking or its representative fails to fulfil its obligation to make an offer of compensation within a reasonable time-limit; this should not prejudice the application of any other measure - especially under supervisory law - which may be considered appropriate; however, it is a condition that liability and the damage and injury sustained should not be in dispute, so that the insurance undertaking is able to make a reasoned offer within the prescribed time-limit; the reasoned offer of compensation should be in writing and contain the grounds on the basis of which liability and damages have been assessed.
(19) In addition to those sanctions, it is appropriate to provide that interest should be payable on the amount of compensation offered by the insurance undertaking or awarded by the court to the injured party when the offer has not been made within the said prescribed time-limit; if Member States have existing national rules which cover the requirement for late-payment interest this provision could be implemented by a reference to those rules.
(20) Injured parties suffering loss or injury as a result of motor vehicle accidents sometimes have difficulty in establishing the name of the insurance undertaking providing insurance against civil liability in respect of the use of motor vehicles involved in an accident.
(21) In the interest of such injured parties, Member States should set up information centres to ensure that such information is made available promptly; those information centres should also make available to injured parties information concerning claims representatives; it is necessary that such centres should cooperate with each other and respond rapidly to requests for information about claims representatives made by centres in other Member States; it seems appropriate that such centres should collect information about the actual termination date of the insurance cover but not about the expiry of the original validity of the policy if the duration of the contract is extended owing to non-cancellation.
(22) Specific provision should be made with respect to vehicles (for example, government or military vehicles) which fall under the exemptions from the obligation to be insured against civil liability.
(23) The injured party may have a legitimate interest in being informed about the identity of the owner or usual driver or the registered keeper of the vehicle, for example if he can obtain compensation only from these persons because the vehicle is not duly insured or the damage exceeds the sum insured, this information should also be provided accordingly.
(24) Certain information provided, such as the name and address of the owner or usual driver of the vehicle and the number of the insurance policy or the registration number of the vehicle, constitutes personal data within the meaning of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data(11); the processing of such data which is required for the purposes of this Directive must therefore comply with the national measures taken pursuant to Directive 95/46/EC; the name and address of the usual driver should be communicated only if national legislation provides for such communication.
(25) It is necessary to make provision for a compensation body to which the injured party may apply where the insurance undertaking has failed to appoint a representative or is manifestly dilatory in settling a claim or where the insurance undertaking cannot be identified to guarantee that the injured party will not remain without the compensation to which he is entitled; the intervention of the compensation body should be limited to rare individual cases where the insurance undertaking has failed to comply with its duties in spite of the dissuasive effect of the potential imposition of penalties.
(26) The role played by the compensation body is that of settling the claim in respect of any loss or injury suffered by the injured party only in cases which are capable of objective determination and therefore the compensation body must limit its activity to verifying that an offer of compensation has been made in accordance with the time-limits and procedures laid down, without any assessment of the merits.
(27) Legal persons who are subrogated by law to the injured party in his claims against the person responsible for the accident or the latter's insurance undertaking (such as, for example, other insurance undertakings or social security bodies) should not be entitled to present the corresponding claim to the compensation body.
(28) The compensation body should have a right of subrogation in so far as it has compensated the injured party; in order to facilitate enforcing the compensation body's claim against the insurance undertaking where it has failed to appoint a claims representative or is manifestly dilatory in settling a claim, the body providing compensation in the injured party's State should enjoy an automatic right of reimbursement with subrogation to the rights of the injured party on the part of the corresponding body in the State where the insurance undertaking is established; the latter body is the best placed to institute proceedings for recourse against the insurance undertaking.
(29) Even though Member States may provide that the claim against the compensation body may be subsidiary, the injured person should not be obliged to present his claim to the person responsible for the accident before presenting it to the compensation body; in this case the injured party should be in at least the same position as in the case of a claim against the guarantee fund under Article 1(4) of Directive 84/5/EEC.
(30) This system can be made to function by means of an agreement between the compensation bodies established or approved by the Member States defining their functions and obligations and the procedures for reimbursement.
(31) Where it is impossible to identify the insurer of the vehicle, provision should be made so that the ultimate debtor in respect of the damages to be paid to the injured party is the guarantee fund provided for in Article 1(4) of Directive 84/5/EEC situated in the Member State where the non-insured vehicle, the use of which has caused the accident, is normally based; where it is impossible to identify the vehicle, provision must be made so that the ultimate debtor is the guarantee fund provided for in Article 1(4) of Directive 84/5/EEC situated in the Member State in which the accident occurred,
Article 1
Scope
1. The objective of this Directive is to lay down special provisions applicable to injured parties entitled to compensation in respect of any loss or injury resulting from accidents occurring in a Member State other than the Member State of residence of the injured party which are caused by the use of vehicles insured and normally based in a Member State.
Without prejudice to the legislation of third countries on civil liability and private international law, this Directive shall also apply to injured parties resident in a Member State and entitled to compensation in respect of any loss or injury resulting from accidents occurring in third countries whose national insurer's bureaux as defined in Article 1(3) of Directive 72/166/EEC have joined the Green Card system whenever such accidents are caused by the use of vehicles insured and normally based in a Member State.
2. Articles 4 and 6 shall apply only in the case of accidents caused by the use of a vehicle
(a) insured through an establishment in a Member State other than the State of residence of the injured party, and
(b) normally based in a Member State other than the State of residence of the injured party.
3. Article 7 shall also apply to accidents caused by third-country vehicles covered by Articles 6 and 7 of Directive 72/166/EEC.
Article 2
Definitions
For the purpose of this Directive:
(a) "insurance undertaking" means an undertaking which has received its official authorisation in accordance with Article 6 or Article 23(2) of Directive 73/239/EEC;
(b) "establishment" means the head office, agency or branch of an insurance undertaking as defined in Article 2(c) of Directive 88/357/EEC;
(c) "vehicle" means a vehicle as defined in Article 1(1) of Directive 72/166/EEC;
(d) "injured party" means an injured party as defined in Article 1(2) of Directive 72/166/EEC;
(e) "the Member State in which the vehicle is normally based" means the territory in which the vehicle is normally based as defined in Article 1(4) of Directive 72/166/EEC.
Article 3
Direct right of action
Each Member State shall ensure that injured parties referred to in Article 1 in accidents within the meaning of that provision enjoy a direct right of action against the insurance undertaking covering the responsible person against civil liability.
Article 4
Claims representatives
1. Each Member State shall take all measures necessary to ensure that all insurance undertakings covering the risks classified in class 10 of point A of the Annex to Directive 73/239/EEC, other than carrier's liability, appoint a claims representative in each Member State other than that in which they have received their official authorisation. The claims representative shall be responsible for handling and settling claims arising from an accident in the cases referred to in Article 1. The claims representative shall be resident or established in the Member State where he is appointed.
2. The choice of its claims representative shall be at the discretion of the insurance undertaking. The Member States may not restrict this choice.
3. The claims representative may work for one or more insurance undertakings.
4. The claims representative shall, in relation to such claims, collect all information necessary in connection with the settlement of the claims and shall take the measures necessary to negotiate a settlement of claims. The requirement of appointing a claims representative shall not preclude the right of the injured party or his insurance undertaking to institute proceedings directly against the person who caused the accident or his insurance undertaking.
5. Claims representatives shall possess sufficient powers to represent the insurance undertaking in relation to injured parties in the cases referred to in Article 1 and to meet their claims in full. They must be capable of examining cases in the official language(s) of the Member State of residence of the injured party.
6. The Member States shall create a duty, backed by appropriate, effective and systematic financial or equivalent administrative penalties, to the effect that, within three months of the date when the injured party presented his claim for compensation either directly to the insurance undertaking of the person who caused the accident or to its claims representative,
(a) the insurance undertaking of the person who caused the accident or his claims representative is required to make a reasoned offer of compensation in cases where liability is not contested and the damages have been quantified, or
(b) the insurance undertaking to whom the claim for compensation has been addressed or his claims representative is required to provide a reasoned reply to the points made in the claim in cases where liability is denied or has not been clearly determined or the damages have not been fully quantified.
Member States shall adopt provisions to ensure that where the offer is not made within the three-month time-limit, interest shall be payable on the amount of compensation offered by the insurance undertaking or awarded by the court to the injured party.
7. The Commission shall report to the European Parliament and Council on the implementation of paragraph 4, first subparagraph, and on the effectiveness of that provision as well as on the equivalence of national penalty provisions before 20 January 2006 and shall submit proposals if necessary.
8. The appointment of a claims representative shall not in itself constitute the opening of a branch within the meaning of Article 1(b) of Directive 92/49/EEC and the claims representative shall not be considered an establishment within the meaning of Article 2(c) of Directive 88/357/EEC or an establishment within the meaning of the Brussels Convention of 27 September 1968 on jurisdiction and the enforcement of judgments in civil and commercial matters(12).
Article 5
Information centres
1. For the purposes of allowing the injured party to seek compensation, each Member State shall establish or approve an information centre responsible:
(a) for keeping a register containing the following information:
1. the registration numbers of motor vehicles normally based in the territory of the State in question;
2. (i) the numbers of the insurance policies covering the use of those vehicles for the risks classified in class 10 of point A of the Annex to Directive 73/239/EEC, other than carrier's liability, and where the period of validity of the policy has expired, also the date of termination of the insurance cover;
(ii) the number of the green card or frontier insurance policy if the vehicle is covered by one of those documents in case the vehicle benefits from the derogation provided for in Article 4(b) of Directive 72/166/EEC;
3. insurance undertakings covering the use of vehicles for the risks classified in class 10 of point A of the Annex to Directive 73/239/EEC, other than carrier's liability, and claims representatives appointed by such insurance undertakings in accordance with Article 4 whose names shall be notified to the information centre in accordance with paragraph 2 of this Article;
4. the list of vehicles which, in each Member State, benefit from the derogation from the requirement for civil liability insurance cover in accordance with Article 4(a) and (b) of Directive 72/166/EEC;
5. regarding the vehicles provided for in point (4):
(i) the name of the authority or the body designated in accordance with the second subparagraph of Article 4(a) of Directive 72/166/EEC as responsible for compensating injured parties in the cases where the procedure provided for in the first indent of Article 2(2) of Directive 72/166/EEC is not applicable, if the vehicle benefits from the derogation provided for in Article 4(a) of Directive 72/166/EEC;
(ii) the name of the body covering the vehicle in the Member State where it is normally based if the vehicle benefits from the derogation provided for in Article 4(b) of Directive 72/166/EEC;
(b) or for coordinating the compilation and dissemination of that information;
(c) and for assisting entitled persons to be apprised of the information mentioned in points (a)(1), (2), (3), (4) and (5).
The information under points (a)(1), (2) and (3) must be preserved for a period of seven years after the termination of the registration of the vehicle or the termination of the insurance contract.
2. Insurance undertakings referred to in paragraph 1(a)(3) shall notify to the information centres of all Member States the name and address of the claims representative which they have appointed in accordance with Article 4 in each of the Member States.
3. The Member States shall ensure that the injured party is entitled for a period of seven years after the accident to obtain without delay from the information centre of the Member State where he resides, the Member State where the vehicle is normally based or the Member State where the accident occurred the following information:
(a) the name and address of the insurance undertaking;
(b) the number of the insurance policy; and
(c) the name and address of the insurance undertaking's claims representative in the State of residence of the injured party.
Information centres shall cooperate with each other.
4. The information centre shall provide the injured party with the name and address of the owner or usual driver or the registered keeper of the vehicle if the injured party has a legitimate interest in obtaining this information. For the purposes of this provision, the information centre shall address itself in particular:
(a) to the insurance undertaking, or
(b) to the vehicle registration agency.
If the vehicle benefits from the derogation provided for in Article 4(a) of Directive 72/166/EEC, the information centre shall inform the injured party of the name of the authority or body designated in accordance with the second subparagraph of Article 4(a) of that Directive as responsible for compensating injured parties in cases where the procedure provided for in the first indent of Article 2(2) of that Directive is not applicable.
If the vehicle benefits from the derogation provided for in Article 4(b) of Directive 72/166/EEC, the information centre shall inform the injured party of the name of the body covering the vehicle in the country where it is normally based.
5. The processing of personal data resulting from the previous paragraphs must be carried out in accordance with national measures taken pursuant to Directive 95/46/EC.
Article 6
Compensation bodies
1. Each Member State shall establish or approve a compensation body responsible for providing compensation to injured parties in the cases referred to in Article 1.
Such injured parties may present a claim to the compensation body in their Member State of residence:
(a) if, within three months of the date when the injured party presented his claim for compensation to the insurance undertaking of the vehicle the use of which caused the accident or to its claims representative, the insurance undertaking or its claims representative has not provided a reasoned reply to the points made in the claim; or
(b) if the insurance undertaking has failed to appoint a claims representative in the State of residence of the injured party in accordance with Article 4(1). In this case, injured parties may not present a claim to the compensation body if they have presented a claim for compensation directly to the insurance undertaking of the vehicle the use of which caused the accident and if they have received a reasoned reply within three months of presenting the claim.
Injured parties may not however present a claim to the compensation body if they have taken legal action directly against the insurance undertaking.
The compensation body shall take action within two months of the date when the injured party presents a claim for compensation to it but shall terminate its action if the insurance undertaking, or its claims representative, subsequently makes a reasoned reply to the claim.
The compensation body shall immediately inform:
(a) the insurance undertaking of the vehicle the use of which caused the accident or the claims representative;
(b) the compensation body in the Member State of the insurance undertaking's establishment which issued the policy;
(c) if known, the person who caused the accident,
that it has received a claim from the injured party and that it will respond to that claim within two months of the presentation of that claim.
This provision shall be without prejudice to the right of the Member States to regard compensation by that body as subsidiary or non-subsidiary and the right to make provision for the settlement of claims between that body and the person or persons who caused the accident and other insurance undertakings or social security bodies required to compensate the injured party in respect of the same accident. However, Member States may not allow the body to make the payment of compensation subject to any conditions other than those laid down in this Directive, in particular the injured party's establishing in any way that the person liable is unable or refuses to pay.
2. The compensation body which has compensated the injured party in his Member State of residence shall be entitled to claim reimbursement of the sum paid by way of compensation from the compensation body in the Member State of the insurance undertaking's establishment which issued the policy.
The latter body shall then be subrogated to the injured party in his rights against the person who caused the accident or his insurance undertaking in so far as the compensation body in the Member State of residence of the injured party has provided compensation for the loss or injury suffered. Each Member State is obliged to acknowledge this subrogation as provided for by any other Member State.
3. This Article shall take effect:
(a) after an agreement has been concluded between the compensation bodies established or approved by the Member States relating to their functions and obligations and the procedures for reimbursement;
(b) from the date fixed by the Commission upon its having ascertained in close cooperation with the Member States that such an agreement has been concluded.
The Commission shall report to the European Parliament and the Council on the implementation of this Article and on its effectiveness before 20 July 2005 and shall submit proposals if necessary.
Article 7
If it is impossible to identify the vehicle or if, within two months following the accident, it is impossible to identify the insurance undertaking, the injured party may apply for compensation from the compensation body in the Member State where he resides. The compensation shall be provided in accordance with the provisions of Article 1 of Directive 84/5/EEC. The compensation body shall then have a claim, on the conditions laid down in Article 6(2) of this Directive:
(a) where the insurance undertaking cannot be identified: against the guarantee fund provided for in Article 1(4) of Directive 84/5/EEC in the Member State where the vehicle is normally based;
(b) in the case of an unidentified vehicle: against the guarantee fund in the Member State in which the accident took place;
(c) in the case of third-country vehicles: against the guarantee fund of the Member State in which the accident took place.
Article 8
Directive 73/239/EEC shall be amended as follows:
(a) In Article 8(1) the following point shall be added:
"(f) communicate the name and address of the claims representative appointed in each Member State other than the Member State in which the authorisation is sought if the risks to be covered are classified in class 10 of point A of the Annex, other than carrier's liability."
(b) In Article 23(2) the following point shall be added:
"(h) communicate the name and address of the claims representative appointed in each Member State other than the Member State in which the authorisation is sought if the risks to be covered are classified in class 10 of point A of the Annex, other than carrier's liability."
Article 9
Directive 88/357/EEC shall be amended as follows:
In Article 12a(4) the following subparagraph shall be added:"If the insurance undertaking has failed to appoint a representative, Member States may give their approval to the claims representative appointed in accordance with Article 4 of Directive 2000/26/EC(13) assuming the function of the representative appointed according to this paragraph."
Article 10
Implementation
1. Member States shall adopt and publish before 20 July 2002 the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.
They shall apply these provisions before 20 January 2003.
2. When these measures are adopted by the Member States, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
3. Without prejudice to paragraph 1, the Member States shall establish or approve the compensation body in accordance with Article 6(1) before 20 January 2002. If the compensation bodies have not concluded an agreement in accordance with Article 6(3) before 20 July 2002, the Commission shall propose measures designed to ensure that the provisions of Articles 6 and 7 take effect before 20 January 2003.
4. Member States may, in accordance with the Treaty, maintain or bring into force provisions which are more favourable to the injured party than the provisions necessary to comply with this Directive.
5. Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field governed by this Directive.
Article 11
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 12
Penalties
The Member States shall fix penalties for breaches of the national provisions which they adopt in implementation of this Directive and take the steps necessary to secure their application. The penalties shall be effective, proportional and dissuasive. The Member States shall notify these provisions to the Commission not later than 20 July 2002 and any subsequent amendments thereof as soon as possible.
Article 13
Addressees
This Directive is addressed to the Member States.
|
[
"UKSI20022706",
"UKSI20022707"
] |
32000L0020
|
2000
|
Directive 2000/20/EC of the European Parliament and of the Council of 16 May 2000 amending Council Directive 64/432/EEC on animal health problems affecting intra-Community trade in bovine animals and swine
Having regard to the Treaty establishing the European Community, and in particular Articles 37 and 152(4)(b) thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the Economic and Social Committee(1),
Following consultation of the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),
Whereas:
(1) Directive 64/432/EEC(3) has been amended and updated by Directive 97/12/EC(4) and by Directive 98/46/EC(5).
(2) Problems concerning the implementation of Directive 64/432/EEC as amended by the two aforementioned Directives require transitional measures to avoid disturbances in trade in live animals of the bovine and porcine species.
(3) Moreover, Directive 64/432/EEC and Council Regulation (EC) No 820/97 of 21 April 1997 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products(6) refer to the creation of computer databases, inter alia for bovine animals, to store information on animals and their movements.
(4) Problems have been encountered with the application of the animal health conditions and in particular in relation to the link with the identification and registration of animals.
(5) Directive 64/432/EEC is to be amended to ensure consistency of Community rules and to allow the Commission to adopt transitional measures allowing the Member States to adapt to the new trade conditions.
(6) As a result, it is appropriate to delay the entry into force of certain provisions in the said Directive.
(7) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(7),
Article 1
Directive 64/432/EEC is hereby amended as follows:
1. the following point shall be added to Article 6(2):
"(e) until 31 December 2000, not be subject to the test requirements laid down in (a) or (b) in the case of bovine animals aged less than 30 months intended for meat production which:
- come from a beef holding officially tuberculosis-free and officially brucellosis-free,
- are accompanied by an animal health certificate with paragraph 7 in Section A of Annex F Model 1 duly completed,
- remain under supervision until their slaughter,
- have not come into contact during transport with bovine animals not coming from herds officially free from those diseases,
and provided that:
- these arrangements are restricted to trade between Member States or regions of Member States with the same health status with regard to tuberculosis or brucellosis,
- the Member State of destination takes all necessary measures to avoid any contamination of indigenous herds,
- the Member States put in place a proper system of random sampling, inspections and controls designed to ensure the efficient implementation of these rules,
- the Commission monitors the proper operation of this Directive so as to ensure that Member States comply fully with the rules;";
2. in the second subparagraph of Article 6(3), "31 December 1999" shall be replaced by "31 December 2000";
3. the following paragraph shall be added to Article 16:
"3. Where necessary to facilitate the changeover to the new arrangements provided for in this Directive, the Commission, acting in accordance with the procedure laid down in Article 17a, may adopt transitional measures applicable for a period of not more than two years.";
4. Article 17 shall be replaced by the following:
"Article 17
1. The Commission shall be assisted by the Standing Veterinary Committee established by Decision 68/361/EEC (hereinafter referred to as the 'Committee').
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The Committee shall adopt its rules of procedure.";
5. the following Article shall be inserted:
"Article 17a
1. The Commission shall be assisted by the Standing Veterinary Committee established by Decision 68/361/EEC (hereinafter referred to as the 'Committee').
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The Committee shall adopt its rules of procedure.";
6. in Annex A, I, 2, point (c), third indent, the word "or" shall be inserted between points (1) and (2).
7. in Annex A, I, 4 and in Annex A, II, 7 point (b) shall be replaced by the following:
"(b) each bovine animal is identified in accordance with Community legislation, and";
8. the following paragraph shall be added to Annex F, Model 1, Section A:
"7. (3) is an animal less than 30 months old intended for meat production originating from a herd which is officially tuberculosis, brucellosis and leukosis free, and is dispatched in accordance with Article 6(2)(e) of Directive 64/432/EEC under licence No ...".
Article 2
1. Member States shall bring into force the laws, regulations or administrative provisions required for compliance with this Directive with effect from 1 December 1999. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive.
Article 3
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20002266"
] |
32000L0032
|
2000
|
Commission Directive 2000/32/EC of 19 May 2000 adapting to technical progress for the 26th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (Text with EEA relevance.)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(2), as last amended by European Parliament and Council Directive 1999/33/EC(3), and in particular Article 28 thereof,
Whereas:
(1) Annex I to Directive 67/548/EEC contains a list of dangerous substances, together with particulars of the classification and labelling of each substance. Present scientific and technical knowledge has shown that the list of dangerous substances in that Annex should be adapted. Certain language versions of the Directive require corrections in specific sections of the foreword and of Table A to Annex I.
(2) Annex III to Directive 67/548/EEC contains a list of phrases indicating the nature of special risks attributed to dangerous substances and preparations. Annex IV to Directive 67/548/EEC contains a list of the phrases indicating the safety advice concerning dangerous substances and preparations. Annex VI to Directive 67/548/EEC contains a guide to the classification and labelling of dangerous substances and preparations. Certain language versions of the Directive require corrections in specific sections of Annexes III, IV and VI.
(3) Annex V to Directive 67/548/EEC lays down the methods for the determination of the physico-chemical properties, toxicity and ecotoxicity of substances and preparations. It is necessary to adapt that Annex to technical progress.
(4) Annex IX to Directive 67/548/EEC contains the provisions relating to child-proof fastenings. Those provisions should be adapted and updated. It is necessary to extend the scope of the use of child-proof fastenings.
(5) The measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation to Technical Progress of the Directives for the Elimination of Technical Barriers to Trade in Dangerous Substances and Preparations,
Article 1
Directive 67/548/EEC is hereby amended as follows:
1. Annex I is amended as follows:
(a) Note Q in Annex 1A to this Directive replaces the corresponding note in the Foreword.
(b) The rows in Annex 1B to this Directive replace the corresponding rows in Table A.
(c) The entries in Annex 1C to this Directive replace the corresponding entries.
(d) The entries in Annex 1D to this Directive are inserted.
2. The risk phrase in Annex 2 to this Directive replaces the corresponding phrase in Annex III.
3. Annex IV is amended as follows:
(a) The safety phrases in Annex 3A to this Directive replace the corresponding phrases in Annex IV.
(b) The combined safety phrases in Annex 3B to this Directive replace the corresponding phrases in Annex IV.
4. Part B of Annex V is amended as follows:
(a) The text in Annex 4A to this Directive replaces Chapter B.10.
(b) The text in Annex 4B to this Directive replaces Chapter B.11.
(c) The text in Annex 4C to this Directive replaces Chapter B.12.
(d) The text in Annex 4D to this Directive replaces Chapters B.13 and B.14.
(e) The text in Annex 4E to this Directive replaces Chapter B.17.
(f) The text in Annex 4F to this Directive replaces Chapter B.23. The title of Chapter B.23 in the explanatory note is changed accordingly.
(g) The text in Annex 4G to this Directive is added.
5. The fourth indent of the general introduction to Part C of Annex V is deleted.
6. The texts in Annex 5 to this Directive replace the corresponding texts in Annex VI.
7. Annex IX is amended as set out in Annex 6 to this Directive.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 June 2001 at the latest. They shall forthwith inform the Commission thereof.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the main provisions of national law which they adopt in the field covered by this Directive and a correlation table between this Directive and the national provisions adopted.
Article 3
This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI19943247"
] |
32000L0025
|
2000
|
Directive 2000/25/EC of the European Parliament and of the Council of 22 May 2000 on action to be taken against the emission of gaseous and particulate pollutants by engines intended to power agricultural or forestry tractors and amending Council Directive 74/150/EEC
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),
Whereas:
(1) To ensure the proper functioning of the internal market, Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors(4) and the 22 specific Directives adopted between 1974 and 1989 harmonised the technical specifications in this field.
(2) In order to further safeguard the environment, it is necessary to supplement the measures already adopted by Council Directive 77/537/EEC of 28 June 1977 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of pollutants from diesel engines for use in wheeled agricultural or forestry tractors(5) (opacity of exhaust gases) with other measures relating, in particular, to physicochemical emissions. By referring to the provisions of Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery(6), this Directive lays down the limit values for emissions of gaseous and particulate pollutants to be applied in successive stages, and the test procedure for internal combustion engines intended to power agricultural or forestry tractors. Compliance with the provisions of Council Directive 88/77/EEC of 3 December 1987 on the approximation of the laws of the Member States relating to the measures to be taken against the emission of gaseous pollutants from diesel engines for use in vehicles(7), can also be accepted as compliance with the requirements of this Directive.
(3) In order to facilitate access to third-country markets, it is necessary to establish equivalence between the requirements of this Directive for the first stage and the requirements laid down in United Nations Economic Commission for Europe (UN/ECE) Regulation No 96 concerning the component type-approval of compression ignition engines intended to be fitted to agricultural or forestry tractors in terms of their pollutant emissions.
(4) In order to maximise the benefits for the European environment and, at the same time, to ensure the unity of the market, it is necessary to adopt very strict mandatory standards at regular intervals. Any further reduction in the limit values and any changes to the test procedure can be adopted only on the basis of studies and research to be conducted into existing and foreseeable technological potential and into the cost effectiveness thereof, in order to allow production on an industrial scale of agricultural or forestry tractors that are capable of meeting these more stringent limits.
(5) Technical progress requires rapid adaptation of the technical requirements set out in the Annexes to this Directive. The Commission is committed to aligning without delay the limit values and dates in this Directive to future changes in Directive 97/68/EC. In every case where the European Parliament and the Council empower the Commission to implement the rules drawn up for agricultural or forestry tractors, a prior consultation procedure involving the Commission and the Member States meeting in committee should be introduced.
(6) The requirements of this Directive supplement those of Directive 77/537/EEC, which is referred to in Item 2.8.1 of Annex II to Directive 74/150/EEC; Directive 74/150/EEC thus needs to be amended in order to add a new Item 2.8.2 in Annex II covering the topic dealt with by this Directive in conjunction with the reference SD (Specific Directive).
(7) The objective of reducing the level of pollutant emissions from agricultural or forestry tractors and the smooth functioning of the internal market for such vehicles cannot be sufficiently achieved by individual Member States and can therefore be better achieved by the approximation of the laws of the Member States relating to measures to be taken against air pollution by such vehicles. The measures contained in this Directive do not go beyond what is necessary to achieve the objectives of the Treaty,
Article 1
Definitions
For the purposes of this Directive:
- "agricultural or forestry tractor" (hereinafter referred to as "tractor") means any vehicle as defined in Article 1(1) of Directive 74/150/EEC,
- "engine" means any internal combustion engine intended to power tractors as defined in Annex I,
- "type-approval of an engine type or family as a separate technical unit with respect to pollutant emissions" means the instrument whereby a Member State certifies that an engine type or family intended to power tractors meets the technical requirements of this Directive,
- "type-approval of a tractor type in respect of pollutant emissions" means the instrument whereby a Member State certifies that a tractor type equipped with an engine meets the technical requirements of this Directive,
- "family of engines" means two or more types of engine that are similar in design and which, therefore, could display characteristics that are comparable in terms of pollutant emissions.
Article 2
Type-approval procedure
The procedure for granting type-approval for an engine type or family in respect of pollutant emissions, the procedure for granting type-approval for tractors with respect to pollutant emissions, and the conditions of the unrestricted placing on the market of such engines and tractors, are as laid down in Directive 74/150/EEC.
Article 3
Obligations
1. Subject to Article 5, any engine type or family must meet the requirements of Annex I.
2. Any tractor type must meet the requirements of Annex II. In this respect type-approvals for engine type or families which have been approved in accordance with Annex I or the provisions mentioned in Annex III shall be recognised.
Article 4
Timetable
1. Member States may not after 30 September 2000:
- refuse to grant EC type-approval or national type-approval in respect of an engine type or family, or
- prohibit the sale, entry into service or use of a new engine, or
- refuse to grant EC type-approval or national type-approval of tractor types, or
- prohibit the use, the sale, the initial entry into service of tractor types,
on grounds relating to air pollution if the pollutants emitted by those engines or the engines fitted to those tractors meet the requirements of this Directive.
2. Member States may no longer grant EC type-approval or national type-approval for a type or family of engines or a tractor type where the pollutants emitted by the engine do not meet the requirements of this Directive:
(a) in stage I
- after 31 December 2000 for engines of categories B and C (power range as defined in Article 9(2) of Directive 97/68/EC);
(b) in stage II
- after 31 December 2000 for engines of categories D and E (power range as defined in Article 9(3) of Directive 97/68/EC),
- after 31 December 2001 for engines of category F (power range as defined in Article 9(3) of Directive 97/68/EC),
- after 31 December 2002 for engines of category G (power range as defined in Article 9(3) of Directive 97/68/EC).
3. Member States shall prohibit the initial entry into service of engines and tractors where the pollutants emitted by the engines do not meet the requirements of the Directive:
- after 30 June 2001 for engines of categories A, B, and C,
- after 31 December 2001 for engines of categories D and E,
- after 31 December 2002 for engines of category F,
- after 31 December 2003 for engines of category G.
However, for tractors fitted with category E or F engines, the above dates shall be postponed for six months.
4. The requirements of paragraph 3 do not apply to engines intended to be installed in tractor types for export to third countries and the replacement of engines for tractors in service.
5. Member States may postpone the dates mentioned in paragraph 3 for two years with respect to engines with a production date prior to the said date. They may grant other exceptions under the conditions laid down in Article 10 of Directive 97/68/EC.
Article 5
Recognition of equivalence and conformity
The authorities of Member States granting EC type-approval for a type or family of engines shall recognise the type-approvals granted in accordance with the provisions of Annex III and the corresponding type-approval marks as being in conformity with this Directive.
Article 6
Further reduction in emission limit values
As soon as the provisions referred to in Article 19 of Directive 97/68/EC are adopted by the European Parliament and the Council, the Commission shall, in accordance with the procedure laid down in Article 13 of Directive 74/150/EEC, without delay align the limit values and dates contained in this Directive with those adopted following the decisions taken pursuant to the abovementioned Article 19.
Article 7
Technical adaptations
Any amendments needed in order to adapt the requirements of the Annexes to technical progress shall be adopted in accordance with the procedure laid down in Article 13 of Directive 74/150/EEC.
Article 8
Amendment of Directive 74/150/EEC
In Annex II to Directive 74/150/EEC the following item 2.8.2 shall be inserted: "2.8.2. Emission of gaseous and particulate pollutants by engines: SD".
Article 9
Transposition into national law
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 29 September 2000. They shall forthwith inform the Commission thereof.
They shall apply these provisions from 31 December 2000.
When Member States adopt these measures, they shall contain a reference to this Directive, or be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 10
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 11
Adressees
This Directive is addressed to the Member States.
|
[
"UKSI20011710"
] |
32000L0037
|
2000
|
Commission Directive 2000/37/EC of 5 June 2000 amending Chapter VIa 'Pharmacovigilance' of Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 81/851/EEC of 28 September 1981 on the appriximation of the laws of the Member States relating to veterinary medicinal products(1), as last amended by Directive 93/40/EEC(2), and in particular Article 42i thereof;
Whereas:
(1) In order to ensure the continued safety of veterinary medicinal products in use, it is necessary to ensure that pharmacovigilance systems in the Community are continually adapted to take account of scientific and technical progress.
(2) For public health protection, relevant data on adverse effects in humans related to the use of veterinary medicines should be collected and evaluated.
(3) The pharmacovigilance systems should consider the available data on lack of efficacy.
(4) In addition, collection of information on adverse reactions due to off-label use, investigations of the validity of the withdrawal period and on potential environmental problems may contribute to improve regular monitoring of good usage of veterinary medicines.
(5) It is necessary to take account of changes arising as a result of international harmonisation of definitions, terminology and technological developments in the field of pharmacovigilance.
(6) The increasing use of the mutual recognition procedure established by Directive 81/851/EEC requires that current procedures for reporting and dissemination of suspected adverse reactions be amended to ensure better co-ordination between Member States.
(7) The increasing use of electronic means of communication of information on adverse reactions to veterinary medicinal products marketed in the Community is intended to allow a single reporting point for adverse reactions, at the same time ensuring that this information is shared with the competent authorities in all Member States.
(8) It is necessary to further define terms currently used within the veterinary pharmacovigilance systems.
(9) It is the interest of the Community to ensure that the veterinary pharmacovigilance systems for centrally authorised medicinal products and those authorised by other procedures are consistent.
(10) Holders of marketing authorisations should additionally be proactively responsible for ongoing pharmacovigilance of the veterinary medicinal products they place on the market.
(11) The measures provided for in this Directive are in conformity with the opinion of the Standing Committee on veterinary medicinal products,
Article 1
Chapter VIa "Pharmacovigilance" of Directive 81/851/EEC is hereby amended as follows:
1. Article 42a, is hereby replaced by the following text:
"Article 42a
In order to ensure the adoption of appropriate regulatory decisions concerning the veterinary medicinal products authorised within the Community, having regard to information obtained about suspected adverse reactions to veterinary medicinal products under normal conditions of use, the Member States shall establish a veterinary pharmacovigilance system. This system shall be used to collect information useful in the surveillance of veterinary medicinal products, with particular reference to a dverse reactions in animals and in human beings related to the use of veterinary medicinal products, and to evaluate such information scientifically.
Such information shall be collated with available data on the sale and prescription of veterinary medicinal products.
This system also takes into account any available information related to the lack of expected efficacy, off-label use, investigations of the validity of the withrawal period and on potential environmental problems, arising from the use of the product, interpreted in accordance with the Commission guidelines referred to in Article 42g, which may have an impact on the evaluation of their benefits and risks."
2. Article 42b, is hereby replaced by the following:
"Article 42b
For the purpose of this Directive, the following definitions shall apply:
(a) 'adverse reaction' means a reaction which is harmful and unintended and which occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or the modification of physiological function,
(b) 'human adverse reaction' means a reaction which is noxious and unintended and which occurs in a human being following exposure to a veterinary medicine,
(c) 'serious adverse reaction' means an adverse reaction which results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly/birth defect, or which results in permanent or prolonged signs in the animals treated;
(d) 'unexpected adverse reaction' means an adverse reaction, the nature, severity or outcome of which is not consistent with the summary of the product characteristics,
(e) 'periodic safety update reports' means the periodical reports containing the records referred to in Article 42d;
(f) 'post-marketing surveillance studies' means pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying and investigating a safety hazard relating to an authorised veterinary medicinal product,
(g) 'off-label use' means the use of a veterinary medicinal product that is not in accordance with the summary of the product characteristics, including the misuse and serious abuse of the product.
For the interpretation of the definitions and principles outlined in this chapter, the marketing authorisation holder and the competent authorities shall refer to the detailed guidance referred to in Article 42g."
3. Article 42c is hereby amended as follows:
(a) in the first paragraph, the words "person responsible for placing the veterinary medicinal product on the market" are changed to "marketing authorisation holder";
(b) in point (a) of the second paragraph, the words "at a single point" are changed to "in order to be accessible at least at one point within the Community";
(c) in point (b) of the second paragraph the words "relevant national or Community guidance" are changed to "guidance referred to in Article 42g";
(d) to the second paragraph the following point (d) is added:
"d) the provision to the competent authorities, of any other information relevant to the evaluation of the benefits and risks afforded by a veterinary medicinal product, including appropriate information on post-marketing surveillance studies."
4. Article 42d, is hereby replaced by the following text:
"Article 42d
1. The marketing authorisation holder shall be required to maintain detailed records of all suspected adverse reactions occurring either in the Community or in a third country.
2. The marketing authorisation holder shall be required to record and to report all suspected serious adverse reactions and human adverse reactions related to the use of veterinary medicinal products, of which he can reasonably be expected to have knowledge, or which are brought to his attention, immediately to the competent authority of the Member State in whose territory the incident occured, and in no case later than 15 calendar days following the receipt of the information.
3. The marketing authorisation holder shall ensure that the suspected serious and unexpected adverse reactions and human adverse reactions, occuring in the territory of a third country, are reported immediately in accordance with the guidance referred to in Article 42g, so that they are available to the Agency and to the competent authorities in the Member State(s) where the veterinary medicinal product is authorised, and in no case later than 15 calendar days following the receipt of the information.
4. In the case of veterinary medicinal products which have been considered within the scope of Directive 87/22/EEC, or which have benefited from the procedures of mutual recognition under Articles 8, 8a and 17(4) and veterinary medicinal products for which there has been a referral to the procedures under Articles 21 and 22 of this Directive, the marketing authorisation holder shall additionally ensure that all suspected serious adverse reactions and human adverse reactions, occurring in the Community, are reported in the format and at intervals to be agreed with the reference Member State or a a competent authority designated as reference Member State, in such a way so as to be accessible to the reference Member State.
5. Unless other requirements have been laid down as condition of the granting of authorisation, records of all adverse reactions shall be submitted to the competent authorities in the form of a periodic safety update report, either immediately upon request or periodically as follows: six monthly for the first two years after authorisation, annually for the subsequent two years, and at the time of the first renewal. Thereafter, the periodic safety update reports shall be submitted at five-yearly intervals together with the application for renewal of the authorisation. The periodic safety update report shall include a scientific evaluation of the benefit and risks afforded by the veterinary medicinal product.
6. Following the granting of a marketing authorisation, the marketing authorisation holder may request the amendment of the periods referred to in this Article according to the procedure laid down by the Commission Regulation (EC) No 541/95(3), if applicable."
5. A new second paragraph is added to Article 42e:"The Member States may impose specific requirements on veterinary practitioners and other health care professionals in respect of the reporting of suspected serious or unexpected adverse reactions and human adverse reactions, in particular where such reporting is a condition of the marketing authorisation."
6. Article 42f, is replaced by the following text:
"Article 42f
1. The Agency, in collaboration with the Member States and the Commission shall set up a data-processing network to facilitate the exchange of pharmacovigilance information regarding medicinal products marked in the Community.
2. Making use of the network foreseen in the first paragraph, Member States shall ensure that reports of suspected serious adverse reactions and human adverse reactions, in accordance with the Standing Committee on veterinary medicinal products guidance referred to in Article 42g, that have taken place on their territory are immediately made available to the Agency and the other Member States, and in any case within 15 calendar days of their notification, at the latest.
3. The Member States shall ensure that reports of suspected serious adverse reactions and human adverse reactions, that have taken place on their territory are immediately made available to the marketing authoriation holder, and in any case within 15 calendar days of their notification, at the latest."
7. Article 42g is amended as follows:
"Article 42g
(a) In order to facilitate the exchange of information about pharmocovigilance within the Community, the Commission, in consultation with the Agency, Member States and the interested parties, shall draw up guidance on the collection, verification and presentation of adverse reaction reports, including technical requirements for electronic exchange of veterinary pharmacovigilance information in accordance with internationally agreed terminology.
(b) This guidance shall be published in Volume 9 of the Rules governing medicinal products in the European Union and shall take account of international harmonisation work carried out in the field of pharmacovigilance."
8. Article 42h is replaced by the following text:
"Article 42h
Where, as a result of the evaluation of veterinary pharmacovigilance data, a Member State considers that a marketing authorisation should be suspended, withdrawn or varied to restrict the indications or availability, amend the posology, add a contraindication or add a new precautionary measure, it shall forthwith inform the Agency, the other Member States and the marketing authorisation holder.
In case of urgency, the Member State concerned may suspend the marketing authorisation of a veterinary medicinal product, provided the Agency, the Commission and the other Member States are informed at the latest on the following working day."
Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 5 December 2001.
When the Member States adopt the provisions set out in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such references shall be adopted by the Member States. The Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20020236"
] |
32000L0038
|
2000
|
Commission Directive 2000/38/EC of 5 June 2000 amending Chapter Va (Pharmacovigilance) of Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products(1), as last amended by Directive 93/39/EEC(2), and in particular Article 29i thereof,
Whereas:
(1) In order to ensure the continued safety of medicinal products in use, it is necessary to ensure that pharmacovigilance systems in the Community are continually adapted to take account of scientific and technical progress.
(2) It is necessary to take account of changes arising as a result of international harmonisation of definitions, terminology and technological developments in the field of pharmacovigilance.
(3) The increasing use of the mutual recognition procedure established by Directive 75/319/EEC requires that current procedures for reporting and dissemination of suspected adverse drug reactions be amended to ensure better coordination between Member States.
(4) The increasing use of electronic networks for communication of information on adverse drug reactions to medicinal products marketed in the Community is intended to allow competent authorities to share the information at the same time.
(5) It is necessary to further define terms currently used within the pharmacovigilance systems.
(6) It is the interst of the Community to ensure that the pharmacovigilance systems for centrally authorised medicinal products and those authorised by other procedures are consistent.
(7) Holders of marketing authorisations should additionally be proactively responsible for on-going pharmacovigilance of the medicinal products they place on the market.
(8) The measures provided for in this Directive are in conformity with the opinion of the Standing Committee on Medicinal Products for Human Use,
Article 1
Chapter Va (Pharmacovigilance) of Directive 75/319/EEC is hereby amended as follows:
1. In Article 29a, the third paragraph is hereby replaced by the following text:"This system shall also take into account any available information on misuse and abuse of medicinal products which may have an impact on the evaluation of their benefits and risks."
2. Article 29b is hereby replaced by the following text:
"Article 29b
For the purpose of this Directive, the following definitions shall apply:
(a) adverse reaction means a response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function;
(b) serious adverse action means an adverse action which results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congential anomaly/birth defect;
(c) unexpected adverse reaction means an adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics;
(d) periodic safety update reports means the periodical reports containing the records referred to in Article 29d;
(e) post-authorisation safety study means a pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying or quantifying a safety hazard relating to an authorised medicinal product;
(f) abuse of medicinal products means persistent or sporadic, intentional excessive use of medicinal products which is accompanied by harmful physical or psychological effects.
For the interpretation of the definitions and principles outlined in this chapter, the marketing authorisation holder and the competent authorities shall refer to the guidance referred to in Article 29g."
3. Article 29c is hereby amended as follows:
(a) in the first paragraph the words "person responsible for placing the medicinal product on the market" are changed to "marketing authorisation holder";
(b) in point (a) of the second paragraph the words "at a single" are changed to "in order to be accessible at least at one";
(c) in point (b) of the second paragraph the words "relevant national or Community guidance" are changed to "guidance referred to in Article 29g";
(d) to the second paragraph the following point (d) is added:
"d) the provision to the competent authorities, of any other information relevant to the evaluation of the benefits and risks afforded by a medicinal product, including appropriate information on post-authorisation safety studies."
4. Article 29d is hereby replaced by the following text:
"Article 29d
1. The marketing authorisation holder shall be required to maintain detailed records of all suspected adverse reactions occurring either in the Community or in a third country.
2. The marketing authorisation holder shall be required to record and to report all suspected serious adverse reactions which are brought to his attention by a health care professional immediately to the competent authority of the Member State in whose territory the incident occurred, and in no case later than 15 calendar days following the receipt of the information.
3. The marketing authorisation holder shall be required to record and report all other suspected serious adverse reactions which meet the reporting criteria in accordance with the guidance referred to in Article 29g of which he can reasonably be expected to have knowledge immediately to the competent authority of the Member State in whose territory the incident occurred, and in no case later than 15 calendar days following the receipt of the information.
4. The marketing authorisation holder shall ensure that all suspected serious unexpected adverse reactions occurring in the territory of a third country and brought to his attention by a health care professional are reported immediately in accordance with the guidance referred to in Article 29g, so that they are available to the Agency and to the competent authorities of the Member States where the medicinal product is authorised, and in no case later than 15 calendar days following the receipt of the information.
5. In the case of medicinal products which have been considered within the scope of Directive 87/22/EEC, or which have benefited from the procedures of mutual recognition foreseen in Articles 7 and 7a of Directive 65/65/EEC, Article 9(4) of this Directive, and medicinal products for which there has been a referral to the procedures foreseen by Articles 13 and 14 of this Directive, the marketing authorisation holder shall additionally ensure that all suspected serious adverse reactions occurring in the Community are reported in the format and at intervals to be agreed with the reference Member State, or a competent authority acting as the reference Member State, in such a way so as to be accessible to the reference Member State.
6. Unless other requirements have been laid down as a condition of the granting of authorisation, or subsequently as indicated in the guidance referred to in Article 29g, records of all adverse reactions shall be submitted to the competent authorities in the form of a periodic safety update report, either immediately upon request or periodically as follows: six monthly for the first two years after authorisation, annually for the subsequent two years, and at the time of the first renewal. Thereafter the periodic safety update reports shall be submitted at five-yearly intervals together with the application for renewal of the authorisation. The periodic safety update reports shall include a scientific evaluation of the benefit and risks afforded by the medicinal products.
7. Following the granting of a marketing authorisation, the marketing authorisation holder may request the amendment of the periods referred to in this article according to the procedure laid down by Commission Regulation (EC) No 541/95(3)."
5. In Article 29e, second paragraph, the words "medical practitioners" are changed to "doctors and other health care professionals":
6. Article 29f is hereby replaced by the following text:
"Article 29f
1. The Agency, in collaboration with the Member States and the Commission shall set up a data-processing network to facilitate the exchange of pharmacovigilance information regarding medicinal products marketed in the Community intended to allow all competent authorities to share the information at the same time.
2. Making use of the network foreseen in the first paragraph, Member States shall ensure that reports of suspected serious adverse reactions that have taken place on their territory are immediately made available to the Agency and the other Member States, and in any case within 15 calendar days of their notification, at the latest.
3. The Member States shall ensure that reports of suspected serious adverse reactions that have taken place on their territory are immediately made available to the marketing authorisation holder, and in any case within 15 calendar day of their notification, at the latest."
7. Article 29g is hereby replaced by the following text:
"Article 29g
(a) In order to facilitate the exchange of information about pharmacovigilance within the Community, the Commission, in consultation with the Agency, Member States and interested parties, shall draw up guidance on the collection, verification and presentation of adverse reaction reports, including technical requirements for electronic exchange of pharmacovigilance information in accordance with internationally agreed formats and shall publish a reference to an internationally agreed medical terminology.
(b) This guidance shall be published in Volume 9 of the Rules governing medicinal products in the European Union and shall take account of international harmonisation work carried out in the field of pharmacovigilance."
8. Article 29h is hereby replaced by the following text:
"Article 29h
Where, as a result of the evaluation of pharmacovigilance data, a Member State considers that a marketing authorisation shold be suspended, withdrawn or varied in accordance with the guidance referred to in Article 29g, it shall forthwith inform the Agency, the other Member States and the marketing authorisation holder.
In case of urgency, the Member State concerned may suspend the marketing authorisation of a medicinal product, provided the Agency, the Commission and the other Member States are informed at the latest on the following working day."
Article 2
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 5 December 2001.
When the Member States adopt the provisions set out in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such references shall be adopted by the Member States. The Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 4
This Directive is adressed to the Member States.
|
[
"UKSI20020236"
] |
32000L0030
|
2000
|
Directive 2000/30/EC of the European Parliament and of the Council of 6 June 2000 on the technical roadside inspection of the roadworthiness of commercial vehicles circulating in the Community
Having regard to the Treaty establishing the European Community, and in particular Article 71(1)(c) and (d) thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
After consulting the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),
Whereas:
(1) The growth of traffic presents all Member States with safety and environmental problems of a similar nature and seriousness.
(2) It is in the interest of road safety, environmental protection and equitable competition that commercial vehicles should be used only if they are maintained to a high degree of technical roadworthiness.
(3) In accordance with Directive 96/96/EC of 20 December 1996 on the approximation of the laws of the Member States relating to roadworthiness tests for motor vehicles and their trailers(4), commercial vehicles undergo an inspection by an authorised body every year.
(4) Article 4 of Directive 94/12/EC(5) provides for a multi-directional approach to the cost/effectiveness aspects of the measures intended to reduce the pollution caused by road transport; whereas the European "Auto-oil I" programme incorporated that approach and gave an objective assessment of all the most profitable measures in the fields of vehicle technology, fuel quality, monitoring and maintenance as well as non-technical measures, in order to reduce emissions by road transport.
(5) In view of that approach, the European Parliament and the Council adopted Directive 98/70/EC(6), intended to improve fuel quality and, with a view to laying down stricter emission standards, Directive 98/69/EC(7), for private motor cars and light commercial vehicles and Directive 1999/96/EC(8) for heavy goods vehicles.
(6) This Directive forms part of the same approach, but it would appear to be more effective from the point of view of environmental protection not at this stage to tighten the standards laid down for roadworthiness tests in Directive 96/96/EC but to provide for technical roadside inspections in order to ensure application of that Directive throughout the year.
(7) The regulated annual roadworthiness test is in fact considered not to be sufficient to guarantee that commercial vehicles tested are in roadworthy condition throughout the year.
(8) Effective enforcement through targeted additional technical roadside inspection is an important cost-effective measure to control the standard of maintenance of commercial vehicles on the road.
(9) Roadside roadworthiness inspections should be carried out without discrimination on grounds of the nationality of the driver or of the country of registration or entry into service of the commercial vehicle.
(10) The method of inspection selection should be based on a targeted approach, giving greatest effort to identifying vehicles that seem most likely to be poorly maintained and thereby enhancing the authorities' operational effectiveness and minimising the costs and delays to drivers and operators.
(11) In the event of serious deficiencies in a vehicle inspected it must be possible to ask the competent authorities of the Member State in which the vehicle is registered or in which the vehicle was brought into service to take appropriate measures and inform the requesting Member State of any follow-up measures taken.
(12) The measures necessary for implementing this Directive shall be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(9).
(13) In accordance with the subsidiarity and proportionality principles as set out in Article 5 of the Treaty, the objectives of the proposed action, namely to establish a regime of roadside inspections of commercial vehicles circulating in the Community, cannot be sufficiently achieved by the Member States and can, therefore, by reason of the scale of the action be better achieved by the Community; this Directive does not go beyond what is necessary for that purpose,
Article 1
1. In order to improve road safety and the environment, the purpose of this Directive shall be to ensure that commercial vehicles circulating within the territories of the Member States of the Community comply more fully with certain technical conditions imposed by Directive 96/96/EC.
2. This Directive establishes certain conditions for roadside inspections of the roadworthiness of commercial vehicles circulating within the territory of the Community.
3. Without prejudice to Community regulations, this Directive shall not, however, affect the Member States' right to carry out inspections not covered by this Directive or to check other aspects of road transport, in particular those relating to commercial vehicles. On the other hand, there is nothing to prevent a Member State, in the context of inspections not covered by the scope of this Directive, from checking the items listed in Annex I in places other than on the public highway.
Article 2
For the purposes of this Directive:
(a) "commercial vehicle" shall mean those motor vehicles and trailers defined in categories 1, 2 and 3 of Annex I to Directive 96/96/EC;
(b) "technical roadside inspection" shall mean an inspection of a technical nature, not announced by the authorities and therefore unexpected, of a commercial vehicle circulating within the territory of a Member State carried out on the public highway by the authorities, or under their supervision;
(c) "roadworthiness test" shall mean a test of a vehicle's technical roadworthiness as provided for in Annex II to Directive 96/96/EC.
Article 3
1. Each Member State shall introduce technical roadside inspections such as will achieve the objectives stated in Article 1 as regards commercial vehicles covered by this Directive, bearing in mind the national arrangements applicable to such vehicles under Directive 96/96/EC.
2. Every technical roadside inspection shall be carried out without discrimination on grounds of the nationality of the driver or of the country of registration or entry into service of the commercial vehicle, bearing in mind the need to minimise the costs and delays entailed for drivers and operators.
Article 4
1. A technical roadside inspection shall comprise one, two or all of the following aspects:
(a) a visual assessment of the maintenance condition of the commercial vehicle when stationary;
(b) a check on a recent roadside technical inspection report as referred to in Article 5 or on the documentation attesting to the vehicle's technical roadworthiness and in particular, in the case of a vehicle registered or put into service in a Member State, proof that the commercial vehicle has undergone a statutory technical roadworthiness test in accordance with Directive 96/96/EC;
(c) an inspection for irregularities covering one, more than one or all of the items to be checked listed in Annex I, point 10.
2. An inspection of the braking systems and exhaust emissions shall be carried out in accordance with the rules laid down in Annex II.
3. Before carrying out an inspection of the items listed in Annex I, point 10, the inspector shall take into consideration the last roadworthiness certificate and/or a recent technical roadside inspection report which the driver may produce.
The inspector may also take into consideration any other safety certificate issued by an approved body, presented, where appropriate, by the driver.
Where these certificates and/or report prove that an inspection of one of the items listed in Annex I, point 10, has been carried out in the course of the preceding three months, that item shall not be checked again, except where justified in particular on the grounds of an obvious defect and/or irregularity.
Article 5
1. The technical roadside inspection report relating to the inspection referred to in Article 4(1)(c) shall be drawn up by the authority or inspector having carried it out. A specimen report is contained in Annex I, point 10 of which contains a checklist. The authority or inspector must tick the relevant boxes. The report must be given to the driver of the commercial vehicle.
2. If the authority or the inspector considers that deficiencies in the maintenance of a commercial vehicle may represent a safety risk such that, as regards the brakes in particular, further examination is justified, the commercial vehicle may be subjected to a more elaborate test at a testing centre in the vicinity, designated by the Member State, in accordance with Article 2 of Directive 96/96/EC.
If it becomes clear that a commercial vehicle presents a serious risk to its occupants or other road users either during the roadside inspection referred to in Article 4(1) or during the more elaborate test referred to in the first subparagraph of this paragraph, use of that vehicle may be prohibited until the dangerous deficiencies discovered have been rectified.
Article 6
Every two years, before 31 March, Member States shall communicate to the Commission the data collected relating to the previous two years concerning the number of commercial vehicles checked, classified by category in accordance with Annex I, point 6 and by the country of registration, and the items checked and defects noted, on the basis of Annex I, point 10.
The first data submitted shall cover a period of two years beginning on 1 January 2003.
The Commission shall forward this information to the European Parliament.
Article 7
1. Member States shall assist one another in applying this Directive. In particular, they shall provide each other with details of the office(s) responsible for carrying out the checks and of the names of contact persons.
2. Serious deficiencies in a commercial vehicle belonging to a non-resident, in particular those resulting in a ban on using the vehicle, shall be reported to the competent authorities of the Member State in which the vehicle is registered or has been put into service by means of the specimen report in Annex I, without prejudice to the prosecution in accordance with the legislation in force in the Member States in which the deficiency was recorded.
Without prejudice to Article 5, the competent authorities of the Member State in which a serious deficiency has been found in a commercial vehicle belonging to a non-resident may ask the competent authorities of the Member State in which the vehicle is registered or has been put into service to take appropriate measures with regard to the offender, for example submitting the vehicle to a further roadworthiness inspection.
The competent authorities to which such a request is made shall notify the competent authorities of the Member State in which the deficiencies of the commercial vehicle were found of any measures taken with regard to the offender.
Article 8
Any amendments which are necessary to adapt Annex I or the technical standards defined in Annex II to technical progress shall be adopted in accordance with the procedure laid down in Article 9(2).
Such amendments must not, however, result in the scope of this Directive being extended.
Article 9
1. The Commission shall be assisted by the Committee on the Adaptation to Technical Progress set up pursuant to Article 8 of Directive 96/96/EC, hereinafter referred to as "the Committee".
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, in compliance with the provisions of Article 8 thereof.
The period provided for in Article 5(6) of Decision 1999/468/EC shall be laid down as three months.
3. The Committee shall adopt its rules of procedure.
Article 10
Member States shall draw up arrangements for the penalties applicable where a driver or operator fails to abide by the technical requirements verified on the basis of this Directive.
They shall take all necessary measures to ensure that these penalties are enforced. The penalties thus provided for shall be effective, proportionate and dissuasive.
Article 11
Within a year of receiving the data referred to in Article 6 from the Member States, the Commission shall submit to the Council a report on the application of this Directive together with a summary of the results achieved.
The first report shall cover the period of two years beginning on 1 January 2003.
Article 12
1. The Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive no later than 6 June 2002. They shall forthwith inform the Commission thereof.
2. When the Member States adopt those measures they shall include references to this Directive or shall add such references on their official publication. The Member States shall lay down the manner in which such references shall be made.
3. The Member States shall communicate to the Commission the texts of the provisions of national law that they adopt in the field governed by this Directive.
Article 13
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 14
This Directive is addressed to the Member States.
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[
"UKSI20022426"
] |
32000L0031
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2000
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Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market ('Directive on electronic commerce')
Having regard to the Treaty establishing the European Community, and in particular Articles 47(2), 55 and 95 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),
Whereas:
(1) The European Union is seeking to forge ever closer links between the States and peoples of Europe, to ensure economic and social progress; in accordance with Article 14(2) of the Treaty, the internal market comprises an area without internal frontiers in which the free movements of goods, services and the freedom of establishment are ensured; the development of information society services within the area without internal frontiers is vital to eliminating the barriers which divide the European peoples.
(2) The development of electronic commerce within the information society offers significant employment opportunities in the Community, particularly in small and medium-sized enterprises, and will stimulate economic growth and investment in innovation by European companies, and can also enhance the competitiveness of European industry, provided that everyone has access to the Internet.
(3) Community law and the characteristics of the Community legal order are a vital asset to enable European citizens and operators to take full advantage, without consideration of borders, of the opportunities afforded by electronic commerce; this Directive therefore has the purpose of ensuring a high level of Community legal integration in order to establish a real area without internal borders for information society services.
(4) It is important to ensure that electronic commerce could fully benefit from the internal market and therefore that, as with Council Directive 89/552/EEC of 3 October 1989 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the pursuit of television broadcasting activities(4), a high level of Community integration is achieved.
(5) The development of information society services within the Community is hampered by a number of legal obstacles to the proper functioning of the internal market which make less attractive the exercise of the freedom of establishment and the freedom to provide services; these obstacles arise from divergences in legislation and from the legal uncertainty as to which national rules apply to such services; in the absence of coordination and adjustment of legislation in the relevant areas, obstacles might be justified in the light of the case-law of the Court of Justice of the European Communities; legal uncertainty exists with regard to the extent to which Member States may control services originating from another Member State.
(6) In the light of Community objectives, of Articles 43 and 49 of the Treaty and of secondary Community law, these obstacles should be eliminated by coordinating certain national laws and by clarifying certain legal concepts at Community level to the extent necessary for the proper functioning of the internal market; by dealing only with certain specific matters which give rise to problems for the internal market, this Directive is fully consistent with the need to respect the principle of subsidiarity as set out in Article 5 of the Treaty.
(7) In order to ensure legal certainty and consumer confidence, this Directive must lay down a clear and general framework to cover certain legal aspects of electronic commerce in the internal market.
(8) The objective of this Directive is to create a legal framework to ensure the free movement of information society services between Member States and not to harmonise the field of criminal law as such.
(9) The free movement of information society services can in many cases be a specific reflection in Community law of a more general principle, namely freedom of expression as enshrined in Article 10(1) of the Convention for the Protection of Human Rights and Fundamental Freedoms, which has been ratified by all the Member States; for this reason, directives covering the supply of information society services must ensure that this activity may be engaged in freely in the light of that Article, subject only to the restrictions laid down in paragraph 2 of that Article and in Article 46(1) of the Treaty; this Directive is not intended to affect national fundamental rules and principles relating to freedom of expression.
(10) In accordance with the principle of proportionality, the measures provided for in this Directive are strictly limited to the minimum needed to achieve the objective of the proper functioning of the internal market; where action at Community level is necessary, and in order to guarantee an area which is truly without internal frontiers as far as electronic commerce is concerned, the Directive must ensure a high level of protection of objectives of general interest, in particular the protection of minors and human dignity, consumer protection and the protection of public health; according to Article 152 of the Treaty, the protection of public health is an essential component of other Community policies.
(11) This Directive is without prejudice to the level of protection for, in particular, public health and consumer interests, as established by Community acts; amongst others, Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts(5) and Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts(6) form a vital element for protecting consumers in contractual matters; those Directives also apply in their entirety to information society services; that same Community acquis, which is fully applicable to information society services, also embraces in particular Council Directive 84/450/EEC of 10 September 1984 concerning misleading and comparative advertising(7), Council Directive 87/102/EEC of 22 December 1986 for the approximation of the laws, regulations and administrative provisions of the Member States concerning consumer credit(8), Council Directive 93/22/EEC of 10 May 1993 on investment services in the securities field(9), Council Directive 90/314/EEC of 13 June 1990 on package travel, package holidays and package tours(10), Directive 98/6/EC of the European Parliament and of the Council of 16 February 1998 on consumer production in the indication of prices of products offered to consumers(11), Council Directive 92/59/EEC of 29 June 1992 on general product safety(12), Directive 94/47/EC of the European Parliament and of the Council of 26 October 1994 on the protection of purchasers in respect of certain aspects on contracts relating to the purchase of the right to use immovable properties on a timeshare basis(13), Directive 98/27/EC of the European Parliament and of the Council of 19 May 1998 on injunctions for the protection of consumers' interests(14), Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions concerning liability for defective products(15), Directive 1999/44/EC of the European Parliament and of the Council of 25 May 1999 on certain aspects of the sale of consumer goods and associated guarantees(16), the future Directive of the European Parliament and of the Council concerning the distance marketing of consumer financial services and Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products(17); this Directive should be without prejudice to Directive 98/43/EC of the European Parliament and of the Council of 6 July 1998 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products(18) adopted within the framework of the internal market, or to directives on the protection of public health; this Directive complements information requirements established by the abovementioned Directives and in particular Directive 97/7/EC.
(12) It is necessary to exclude certain activities from the scope of this Directive, on the grounds that the freedom to provide services in these fields cannot, at this stage, be guaranteed under the Treaty or existing secondary legislation; excluding these activities does not preclude any instruments which might prove necessary for the proper functioning of the internal market; taxation, particularly value added tax imposed on a large number of the services covered by this Directive, must be excluded form the scope of this Directive.
(13) This Directive does not aim to establish rules on fiscal obligations nor does it pre-empt the drawing up of Community instruments concerning fiscal aspects of electronic commerce.
(14) The protection of individuals with regard to the processing of personal data is solely governed by Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data(19) and Directive 97/66/EC of the European Parliament and of the Council of 15 December 1997 concerning the processing of personal data and the protection of privacy in the telecommunications sector(20) which are fully applicable to information society services; these Directives already establish a Community legal framework in the field of personal data and therefore it is not necessary to cover this issue in this Directive in order to ensure the smooth functioning of the internal market, in particular the free movement of personal data between Member States; the implementation and application of this Directive should be made in full compliance with the principles relating to the protection of personal data, in particular as regards unsolicited commercial communication and the liability of intermediaries; this Directive cannot prevent the anonymous use of open networks such as the Internet.
(15) The confidentiality of communications is guaranteed by Article 5 Directive 97/66/EC; in accordance with that Directive, Member States must prohibit any kind of interception or surveillance of such communications by others than the senders and receivers, except when legally authorised.
(16) The exclusion of gambling activities from the scope of application of this Directive covers only games of chance, lotteries and betting transactions, which involve wagering a stake with monetary value; this does not cover promotional competitions or games where the purpose is to encourage the sale of goods or services and where payments, if they arise, serve only to acquire the promoted goods or services.
(17) The definition of information society services already exists in Community law in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services(21) and in Directive 98/84/EC of the European Parliament and of the Council of 20 November 1998 on the legal protection of services based on, or consisting of, conditional access(22); this definition covers any service normally provided for remuneration, at a distance, by means of electronic equipment for the processing (including digital compression) and storage of data, and at the individual request of a recipient of a service; those services referred to in the indicative list in Annex V to Directive 98/34/EC which do not imply data processing and storage are not covered by this definition.
(18) Information society services span a wide range of economic activities which take place on-line; these activities can, in particular, consist of selling goods on-line; activities such as the delivery of goods as such or the provision of services off-line are not covered; information society services are not solely restricted to services giving rise to on-line contracting but also, in so far as they represent an economic activity, extend to services which are not remunerated by those who receive them, such as those offering on-line information or commercial communications, or those providing tools allowing for search, access and retrieval of data; information society services also include services consisting of the transmission of information via a communication network, in providing access to a communication network or in hosting information provided by a recipient of the service; television broadcasting within the meaning of Directive EEC/89/552 and radio broadcasting are not information society services because they are not provided at individual request; by contrast, services which are transmitted point to point, such as video-on-demand or the provision of commercial communications by electronic mail are information society services; the use of electronic mail or equivalent individual communications for instance by natural persons acting outside their trade, business or profession including their use for the conclusion of contracts between such persons is not an information society service; the contractual relationship between an employee and his employer is not an information society service; activities which by their very nature cannot be carried out at a distance and by electronic means, such as the statutory auditing of company accounts or medical advice requiring the physical examination of a patient are not information society services.
(19) The place at which a service provider is established should be determined in conformity with the case-law of the Court of Justice according to which the concept of establishment involves the actual pursuit of an economic activity through a fixed establishment for an indefinite period; this requirement is also fulfilled where a company is constituted for a given period; the place of establishment of a company providing services via an Internet website is not the place at which the technology supporting its website is located or the place at which its website is accessible but the place where it pursues its economic activity; in cases where a provider has several places of establishment it is important to determine from which place of establishment the service concerned is provided; in cases where it is difficult to determine from which of several places of establishment a given service is provided, this is the place where the provider has the centre of his activities relating to this particular service.
(20) The definition of "recipient of a service" covers all types of usage of information society services, both by persons who provide information on open networks such as the Internet and by persons who seek information on the Internet for private or professional reasons.
(21) The scope of the coordinated field is without prejudice to future Community harmonisation relating to information society services and to future legislation adopted at national level in accordance with Community law; the coordinated field covers only requirements relating to on-line activities such as on-line information, on-line advertising, on-line shopping, on-line contracting and does not concern Member States' legal requirements relating to goods such as safety standards, labelling obligations, or liability for goods, or Member States' requirements relating to the delivery or the transport of goods, including the distribution of medicinal products; the coordinated field does not cover the exercise of rights of pre-emption by public authorities concerning certain goods such as works of art.
(22) Information society services should be supervised at the source of the activity, in order to ensure an effective protection of public interest objectives; to that end, it is necessary to ensure that the competent authority provides such protection not only for the citizens of its own country but for all Community citizens; in order to improve mutual trust between Member States, it is essential to state clearly this responsibility on the part of the Member State where the services originate; moreover, in order to effectively guarantee freedom to provide services and legal certainty for suppliers and recipients of services, such information society services should in principle be subject to the law of the Member State in which the service provider is established.
(23) This Directive neither aims to establish additional rules on private international law relating to conflicts of law nor does it deal with the jurisdiction of Courts; provisions of the applicable law designated by rules of private international law must not restrict the freedom to provide information society services as established in this Directive.
(24) In the context of this Directive, notwithstanding the rule on the control at source of information society services, it is legitimate under the conditions established in this Directive for Member States to take measures to restrict the free movement of information society services.
(25) National courts, including civil courts, dealing with private law disputes can take measures to derogate from the freedom to provide information society services in conformity with conditions established in this Directive.
(26) Member States, in conformity with conditions established in this Directive, may apply their national rules on criminal law and criminal proceedings with a view to taking all investigative and other measures necessary for the detection and prosecution of criminal offences, without there being a need to notify such measures to the Commission.
(27) This Directive, together with the future Directive of the European Parliament and of the Council concerning the distance marketing of consumer financial services, contributes to the creating of a legal framework for the on-line provision of financial services; this Directive does not pre-empt future initiatives in the area of financial services in particular with regard to the harmonisation of rules of conduct in this field; the possibility for Member States, established in this Directive, under certain circumstances of restricting the freedom to provide information society services in order to protect consumers also covers measures in the area of financial services in particular measures aiming at protecting investors.
(28) The Member States' obligation not to subject access to the activity of an information society service provider to prior authorisation does not concern postal services covered by Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common rules for the development of the internal market of Community postal services and the improvement of quality of service(23) consisting of the physical delivery of a printed electronic mail message and does not affect voluntary accreditation systems, in particular for providers of electronic signature certification service.
(29) Commercial communications are essential for the financing of information society services and for developing a wide variety of new, charge-free services; in the interests of consumer protection and fair trading, commercial communications, including discounts, promotional offers and promotional competitions or games, must meet a number of transparency requirements; these requirements are without prejudice to Directive 97/7/EC; this Directive should not affect existing Directives on commercial communications, in particular Directive 98/43/EC.
(30) The sending of unsolicited commercial communications by electronic mail may be undesirable for consumers and information society service providers and may disrupt the smooth functioning of interactive networks; the question of consent by recipient of certain forms of unsolicited commercial communications is not addressed by this Directive, but has already been addressed, in particular, by Directive 97/7/EC and by Directive 97/66/EC; in Member States which authorise unsolicited commercial communications by electronic mail, the setting up of appropriate industry filtering initiatives should be encouraged and facilitated; in addition it is necessary that in any event unsolicited commercial communities are clearly identifiable as such in order to improve transparency and to facilitate the functioning of such industry initiatives; unsolicited commercial communications by electronic mail should not result in additional communication costs for the recipient.
(31) Member States which allow the sending of unsolicited commercial communications by electronic mail without prior consent of the recipient by service providers established in their territory have to ensure that the service providers consult regularly and respect the opt-out registers in which natural persons not wishing to receive such commercial communications can register themselves.
(32) In order to remove barriers to the development of cross-border services within the Community which members of the regulated professions might offer on the Internet, it is necessary that compliance be guaranteed at Community level with professional rules aiming, in particular, to protect consumers or public health; codes of conduct at Community level would be the best means of determining the rules on professional ethics applicable to commercial communication; the drawing-up or, where appropriate, the adaptation of such rules should be encouraged without prejudice to the autonomy of professional bodies and associations.
(33) This Directive complements Community law and national law relating to regulated professions maintaining a coherent set of applicable rules in this field.
(34) Each Member State is to amend its legislation containing requirements, and in particular requirements as to form, which are likely to curb the use of contracts by electronic means; the examination of the legislation requiring such adjustment should be systematic and should cover all the necessary stages and acts of the contractual process, including the filing of the contract; the result of this amendment should be to make contracts concluded electronically workable; the legal effect of electronic signatures is dealt with by Directive 1999/93/EC of the European Parliament and of the Council of 13 December 1999 on a Community framework for electronic signatures(24); the acknowledgement of receipt by a service provider may take the form of the on-line provision of the service paid for.
(35) This Directive does not affect Member States' possibility of maintaining or establishing general or specific legal requirements for contracts which can be fulfilled by electronic means, in particular requirements concerning secure electronic signatures.
(36) Member States may maintain restrictions for the use of electronic contracts with regard to contracts requiring by law the involvement of courts, public authorities, or professions exercising public authority; this possibility also covers contracts which require the involvement of courts, public authorities, or professions exercising public authority in order to have an effect with regard to third parties as well as contracts requiring by law certification or attestation by a notary.
(37) Member States' obligation to remove obstacles to the use of electronic contracts concerns only obstacles resulting from legal requirements and not practical obstacles resulting from the impossibility of using electronic means in certain cases.
(38) Member States' obligation to remove obstacles to the use of electronic contracts is to be implemented in conformity with legal requirements for contracts enshrined in Community law.
(39) The exceptions to the provisions concerning the contracts concluded exclusively by electronic mail or by equivalent individual communications provided for by this Directive, in relation to information to be provided and the placing of orders, should not enable, as a result, the by-passing of those provisions by providers of information society services.
(40) Both existing and emerging disparities in Member States' legislation and case-law concerning liability of service providers acting as intermediaries prevent the smooth functioning of the internal market, in particular by impairing the development of cross-border services and producing distortions of competition; service providers have a duty to act, under certain circumstances, with a view to preventing or stopping illegal activities; this Directive should constitute the appropriate basis for the development of rapid and reliable procedures for removing and disabling access to illegal information; such mechanisms could be developed on the basis of voluntary agreements between all parties concerned and should be encouraged by Member States; it is in the interest of all parties involved in the provision of information society services to adopt and implement such procedures; the provisions of this Directive relating to liability should not preclude the development and effective operation, by the different interested parties, of technical systems of protection and identification and of technical surveillance instruments made possible by digital technology within the limits laid down by Directives 95/46/EC and 97/66/EC.
(41) This Directive strikes a balance between the different interests at stake and establishes principles upon which industry agreements and standards can be based.
(42) The exemptions from liability established in this Directive cover only cases where the activity of the information society service provider is limited to the technical process of operating and giving access to a communication network over which information made available by third parties is transmitted or temporarily stored, for the sole purpose of making the transmission more efficient; this activity is of a mere technical, automatic and passive nature, which implies that the information society service provider has neither knowledge of nor control over the information which is transmitted or stored.
(43) A service provider can benefit from the exemptions for "mere conduit" and for "caching" when he is in no way involved with the information transmitted; this requires among other things that he does not modify the information that he transmits; this requirement does not cover manipulations of a technical nature which take place in the course of the transmission as they do not alter the integrity of the information contained in the transmission.
(44) A service provider who deliberately collaborates with one of the recipients of his service in order to undertake illegal acts goes beyond the activities of "mere conduit" or "caching" and as a result cannot benefit from the liability exemptions established for these activities.
(45) The limitations of the liability of intermediary service providers established in this Directive do not affect the possibility of injunctions of different kinds; such injunctions can in particular consist of orders by courts or administrative authorities requiring the termination or prevention of any infringement, including the removal of illegal information or the disabling of access to it.
(46) In order to benefit from a limitation of liability, the provider of an information society service, consisting of the storage of information, upon obtaining actual knowledge or awareness of illegal activities has to act expeditiously to remove or to disable access to the information concerned; the removal or disabling of access has to be undertaken in the observance of the principle of freedom of expression and of procedures established for this purpose at national level; this Directive does not affect Member States' possibility of establishing specific requirements which must be fulfilled expeditiously prior to the removal or disabling of information.
(47) Member States are prevented from imposing a monitoring obligation on service providers only with respect to obligations of a general nature; this does not concern monitoring obligations in a specific case and, in particular, does not affect orders by national authorities in accordance with national legislation.
(48) This Directive does not affect the possibility for Member States of requiring service providers, who host information provided by recipients of their service, to apply duties of care, which can reasonably be expected from them and which are specified by national law, in order to detect and prevent certain types of illegal activities.
(49) Member States and the Commission are to encourage the drawing-up of codes of conduct; this is not to impair the voluntary nature of such codes and the possibility for interested parties of deciding freely whether to adhere to such codes.
(50) It is important that the proposed directive on the harmonisation of certain aspects of copyright and related rights in the information society and this Directive come into force within a similar time scale with a view to establishing a clear framework of rules relevant to the issue of liability of intermediaries for copyright and relating rights infringements at Community level.
(51) Each Member State should be required, where necessary, to amend any legislation which is liable to hamper the use of schemes for the out-of-court settlement of disputes through electronic channels; the result of this amendment must be to make the functioning of such schemes genuinely and effectively possible in law and in practice, even across borders.
(52) The effective exercise of the freedoms of the internal market makes it necessary to guarantee victims effective access to means of settling disputes; damage which may arise in connection with information society services is characterised both by its rapidity and by its geographical extent; in view of this specific character and the need to ensure that national authorities do not endanger the mutual confidence which they should have in one another, this Directive requests Member States to ensure that appropriate court actions are available; Member States should examine the need to provide access to judicial procedures by appropriate electronic means.
(53) Directive 98/27/EC, which is applicable to information society services, provides a mechanism relating to actions for an injunction aimed at the protection of the collective interests of consumers; this mechanism will contribute to the free movement of information society services by ensuring a high level of consumer protection.
(54) The sanctions provided for under this Directive are without prejudice to any other sanction or remedy provided under national law; Member States are not obliged to provide criminal sanctions for infringement of national provisions adopted pursuant to this Directive.
(55) This Directive does not affect the law applicable to contractual obligations relating to consumer contracts; accordingly, this Directive cannot have the result of depriving the consumer of the protection afforded to him by the mandatory rules relating to contractual obligations of the law of the Member State in which he has his habitual residence.
(56) As regards the derogation contained in this Directive regarding contractual obligations concerning contracts concluded by consumers, those obligations should be interpreted as including information on the essential elements of the content of the contract, including consumer rights, which have a determining influence on the decision to contract.
(57) The Court of Justice has consistently held that a Member State retains the right to take measures against a service provider that is established in another Member State but directs all or most of his activity to the territory of the first Member State if the choice of establishment was made with a view to evading the legislation that would have applied to the provider had he been established on the territory of the first Member State.
(58) This Directive should not apply to services supplied by service providers established in a third country; in view of the global dimension of electronic commerce, it is, however, appropriate to ensure that the Community rules are consistent with international rules; this Directive is without prejudice to the results of discussions within international organisations (amongst others WTO, OECD, Uncitral) on legal issues.
(59) Despite the global nature of electronic communications, coordination of national regulatory measures at European Union level is necessary in order to avoid fragmentation of the internal market, and for the establishment of an appropriate European regulatory framework; such coordination should also contribute to the establishment of a common and strong negotiating position in international forums.
(60) In order to allow the unhampered development of electronic commerce, the legal framework must be clear and simple, predictable and consistent with the rules applicable at international level so that it does not adversely affect the competitiveness of European industry or impede innovation in that sector.
(61) If the market is actually to operate by electronic means in the context of globalisation, the European Union and the major non-European areas need to consult each other with a view to making laws and procedures compatible.
(62) Cooperation with third countries should be strengthened in the area of electronic commerce, in particular with applicant countries, the developing countries and the European Union's other trading partners.
(63) The adoption of this Directive will not prevent the Member States from taking into account the various social, societal and cultural implications which are inherent in the advent of the information society; in particular it should not hinder measures which Member States might adopt in conformity with Community law to achieve social, cultural and democratic goals taking into account their linguistic diversity, national and regional specificities as well as their cultural heritage, and to ensure and maintain public access to the widest possible range of information society services; in any case, the development of the information society is to ensure that Community citizens can have access to the cultural European heritage provided in the digital environment.
(64) Electronic communication offers the Member States an excellent means of providing public services in the cultural, educational and linguistic fields.
(65) The Council, in its resolution of 19 January 1999 on the consumer dimension of the information society(25), stressed that the protection of consumers deserved special attention in this field; the Commission will examine the degree to which existing consumer protection rules provide insufficient protection in the context of the information society and will identify, where necessary, the deficiencies of this legislation and those issues which could require additional measures; if need be, the Commission should make specific additional proposals to resolve such deficiencies that will thereby have been identified,
CHAPTER I
GENERAL PROVISIONS
Article 1
Objective and scope
1. This Directive seeks to contribute to the proper functioning of the internal market by ensuring the free movement of information society services between the Member States.
2. This Directive approximates, to the extent necessary for the achievement of the objective set out in paragraph 1, certain national provisions on information society services relating to the internal market, the establishment of service providers, commercial communications, electronic contracts, the liability of intermediaries, codes of conduct, out-of-court dispute settlements, court actions and cooperation between Member States.
3. This Directive complements Community law applicable to information society services without prejudice to the level of protection for, in particular, public health and consumer interests, as established by Community acts and national legislation implementing them in so far as this does not restrict the freedom to provide information society services.
4. This Directive does not establish additional rules on private international law nor does it deal with the jurisdiction of Courts.
5. This Directive shall not apply to:
(a) the field of taxation;
(b) questions relating to information society services covered by Directives 95/46/EC and 97/66/EC;
(c) questions relating to agreements or practices governed by cartel law;
(d) the following activities of information society services:
- the activities of notaries or equivalent professions to the extent that they involve a direct and specific connection with the exercise of public authority,
- the representation of a client and defence of his interests before the courts,
- gambling activities which involve wagering a stake with monetary value in games of chance, including lotteries and betting transactions.
6. This Directive does not affect measures taken at Community or national level, in the respect of Community law, in order to promote cultural and linguistic diversity and to ensure the defence of pluralism.
Article 2
Definitions
For the purpose of this Directive, the following terms shall bear the following meanings:
(a) "information society services": services within the meaning of Article 1(2) of Directive 98/34/EC as amended by Directive 98/48/EC;
(b) "service provider": any natural or legal person providing an information society service;
(c) "established service provider": a service provider who effectively pursues an economic activity using a fixed establishment for an indefinite period. The presence and use of the technical means and technologies required to provide the service do not, in themselves, constitute an establishment of the provider;
(d) "recipient of the service": any natural or legal person who, for professional ends or otherwise, uses an information society service, in particular for the purposes of seeking information or making it accessible;
(e) "consumer": any natural person who is acting for purposes which are outside his or her trade, business or profession;
(f) "commercial communication": any form of communication designed to promote, directly or indirectly, the goods, services or image of a company, organisation or person pursuing a commercial, industrial or craft activity or exercising a regulated profession. The following do not in themselves constitute commercial communications:
- information allowing direct access to the activity of the company, organisation or person, in particular a domain name or an electronic-mail address,
- communications relating to the goods, services or image of the company, organisation or person compiled in an independent manner, particularly when this is without financial consideration;
(g) "regulated profession": any profession within the meaning of either Article 1(d) of Council Directive 89/48/EEC of 21 December 1988 on a general system for the recognition of higher-education diplomas awarded on completion of professional education and training of at least three-years' duration(26) or of Article 1(f) of Council Directive 92/51/EEC of 18 June 1992 on a second general system for the recognition of professional education and training to supplement Directive 89/48/EEC(27);
(h) "coordinated field": requirements laid down in Member States' legal systems applicable to information society service providers or information society services, regardless of whether they are of a general nature or specifically designed for them.
(i) The coordinated field concerns requirements with which the service provider has to comply in respect of:
- the taking up of the activity of an information society service, such as requirements concerning qualifications, authorisation or notification,
- the pursuit of the activity of an information society service, such as requirements concerning the behaviour of the service provider, requirements regarding the quality or content of the service including those applicable to advertising and contracts, or requirements concerning the liability of the service provider;
(ii) The coordinated field does not cover requirements such as:
- requirements applicable to goods as such,
- requirements applicable to the delivery of goods,
- requirements applicable to services not provided by electronic means.
Article 3
Internal market
1. Each Member State shall ensure that the information society services provided by a service provider established on its territory comply with the national provisions applicable in the Member State in question which fall within the coordinated field.
2. Member States may not, for reasons falling within the coordinated field, restrict the freedom to provide information society services from another Member State.
3. Paragraphs 1 and 2 shall not apply to the fields referred to in the Annex.
4. Member States may take measures to derogate from paragraph 2 in respect of a given information society service if the following conditions are fulfilled:
(a) the measures shall be:
(i) necessary for one of the following reasons:
- public policy, in particular the prevention, investigation, detection and prosecution of criminal offences, including the protection of minors and the fight against any incitement to hatred on grounds of race, sex, religion or nationality, and violations of human dignity concerning individual persons,
- the protection of public health,
- public security, including the safeguarding of national security and defence,
- the protection of consumers, including investors;
(ii) taken against a given information society service which prejudices the objectives referred to in point (i) or which presents a serious and grave risk of prejudice to those objectives;
(iii) proportionate to those objectives;
(b) before taking the measures in question and without prejudice to court proceedings, including preliminary proceedings and acts carried out in the framework of a criminal investigation, the Member State has:
- asked the Member State referred to in paragraph 1 to take measures and the latter did not take such measures, or they were inadequate,
- notified the Commission and the Member State referred to in paragraph 1 of its intention to take such measures.
5. Member States may, in the case of urgency, derogate from the conditions stipulated in paragraph 4(b). Where this is the case, the measures shall be notified in the shortest possible time to the Commission and to the Member State referred to in paragraph 1, indicating the reasons for which the Member State considers that there is urgency.
6. Without prejudice to the Member State's possibility of proceeding with the measures in question, the Commission shall examine the compatibility of the notified measures with Community law in the shortest possible time; where it comes to the conclusion that the measure is incompatible with Community law, the Commission shall ask the Member State in question to refrain from taking any proposed measures or urgently to put an end to the measures in question.
CHAPTER II
PRINCIPLES
Section 1: Establishment and information requirements
Article 4
Principle excluding prior authorisation
1. Member States shall ensure that the taking up and pursuit of the activity of an information society service provider may not be made subject to prior authorisation or any other requirement having equivalent effect.
2. Paragraph 1 shall be without prejudice to authorisation schemes which are not specifically and exclusively targeted at information society services, or which are covered by Directive 97/13/EC of the European Parliament and of the Council of 10 April 1997 on a common framework for general authorisations and individual licences in the field of telecommunications services(28).
Article 5
General information to be provided
1. In addition to other information requirements established by Community law, Member States shall ensure that the service provider shall render easily, directly and permanently accessible to the recipients of the service and competent authorities, at least the following information:
(a) the name of the service provider;
(b) the geographic address at which the service provider is established;
(c) the details of the service provider, including his electronic mail address, which allow him to be contacted rapidly and communicated with in a direct and effective manner;
(d) where the service provider is registered in a trade or similar public register, the trade register in which the service provider is entered and his registration number, or equivalent means of identification in that register;
(e) where the activity is subject to an authorisation scheme, the particulars of the relevant supervisory authority;
(f) as concerns the regulated professions:
- any professional body or similar institution with which the service provider is registered,
- the professional title and the Member State where it has been granted,
- a reference to the applicable professional rules in the Member State of establishment and the means to access them;
(g) where the service provider undertakes an activity that is subject to VAT, the identification number referred to in Article 22(1) of the sixth Council Directive 77/388/EEC of 17 May 1977 on the harmonisation of the laws of the Member States relating to turnover taxes - Common system of value added tax: uniform basis of assessment(29).
2. In addition to other information requirements established by Community law, Member States shall at least ensure that, where information society services refer to prices, these are to be indicated clearly and unambiguously and, in particular, must indicate whether they are inclusive of tax and delivery costs.
Section 2: Commercial communications
Article 6
Information to be provided
In addition to other information requirements established by Community law, Member States shall ensure that commercial communications which are part of, or constitute, an information society service comply at least with the following conditions:
(a) the commercial communication shall be clearly identifiable as such;
(b) the natural or legal person on whose behalf the commercial communication is made shall be clearly identifiable;
(c) promotional offers, such as discounts, premiums and gifts, where permitted in the Member State where the service provider is established, shall be clearly identifiable as such, and the conditions which are to be met to qualify for them shall be easily accessible and be presented clearly and unambiguously;
(d) promotional competitions or games, where permitted in the Member State where the service provider is established, shall be clearly identifiable as such, and the conditions for participation shall be easily accessible and be presented clearly and unambiguously.
Article 7
Unsolicited commercial communication
1. In addition to other requirements established by Community law, Member States which permit unsolicited commercial communication by electronic mail shall ensure that such commercial communication by a service provider established in their territory shall be identifiable clearly and unambiguously as such as soon as it is received by the recipient.
2. Without prejudice to Directive 97/7/EC and Directive 97/66/EC, Member States shall take measures to ensure that service providers undertaking unsolicited commercial communications by electronic mail consult regularly and respect the opt-out registers in which natural persons not wishing to receive such commercial communications can register themselves.
Article 8
Regulated professions
1. Member States shall ensure that the use of commercial communications which are part of, or constitute, an information society service provided by a member of a regulated profession is permitted subject to compliance with the professional rules regarding, in particular, the independence, dignity and honour of the profession, professional secrecy and fairness towards clients and other members of the profession.
2. Without prejudice to the autonomy of professional bodies and associations, Member States and the Commission shall encourage professional associations and bodies to establish codes of conduct at Community level in order to determine the types of information that can be given for the purposes of commercial communication in conformity with the rules referred to in paragraph 1
3. When drawing up proposals for Community initiatives which may become necessary to ensure the proper functioning of the Internal Market with regard to the information referred to in paragraph 2, the Commission shall take due account of codes of conduct applicable at Community level and shall act in close cooperation with the relevant professional associations and bodies.
4. This Directive shall apply in addition to Community Directives concerning access to, and the exercise of, activities of the regulated professions.
Section 3: Contracts concluded by electronic means
Article 9
Treatment of contracts
1. Member States shall ensure that their legal system allows contracts to be concluded by electronic means. Member States shall in particular ensure that the legal requirements applicable to the contractual process neither create obstacles for the use of electronic contracts nor result in such contracts being deprived of legal effectiveness and validity on account of their having been made by electronic means.
2. Member States may lay down that paragraph 1 shall not apply to all or certain contracts falling into one of the following categories:
(a) contracts that create or transfer rights in real estate, except for rental rights;
(b) contracts requiring by law the involvement of courts, public authorities or professions exercising public authority;
(c) contracts of suretyship granted and on collateral securities furnished by persons acting for purposes outside their trade, business or profession;
(d) contracts governed by family law or by the law of succession.
3. Member States shall indicate to the Commission the categories referred to in paragraph 2 to which they do not apply paragraph 1. Member States shall submit to the Commission every five years a report on the application of paragraph 2 explaining the reasons why they consider it necessary to maintain the category referred to in paragraph 2(b) to which they do not apply paragraph 1.
Article 10
Information to be provided
1. In addition to other information requirements established by Community law, Member States shall ensure, except when otherwise agreed by parties who are not consumers, that at least the following information is given by the service provider clearly, comprehensibly and unambiguously and prior to the order being placed by the recipient of the service:
(a) the different technical steps to follow to conclude the contract;
(b) whether or not the concluded contract will be filed by the service provider and whether it will be accessible;
(c) the technical means for identifying and correcting input errors prior to the placing of the order;
(d) the languages offered for the conclusion of the contract.
2. Member States shall ensure that, except when otherwise agreed by parties who are not consumers, the service provider indicates any relevant codes of conduct to which he subscribes and information on how those codes can be consulted electronically.
3. Contract terms and general conditions provided to the recipient must be made available in a way that allows him to store and reproduce them.
4. Paragraphs 1 and 2 shall not apply to contracts concluded exclusively by exchange of electronic mail or by equivalent individual communications.
Article 11
Placing of the order
1. Member States shall ensure, except when otherwise agreed by parties who are not consumers, that in cases where the recipient of the service places his order through technological means, the following principles apply:
- the service provider has to acknowledge the receipt of the recipient's order without undue delay and by electronic means,
- the order and the acknowledgement of receipt are deemed to be received when the parties to whom they are addressed are able to access them.
2. Member States shall ensure that, except when otherwise agreed by parties who are not consumers, the service provider makes available to the recipient of the service appropriate, effective and accessible technical means allowing him to identify and correct input errors, prior to the placing of the order.
3. Paragraph 1, first indent, and paragraph 2 shall not apply to contracts concluded exclusively by exchange of electronic mail or by equivalent individual communications.
Section 4: Liability of intermediary service providers
Article 12
"Mere conduit"
1. Where an information society service is provided that consists of the transmission in a communication network of information provided by a recipient of the service, or the provision of access to a communication network, Member States shall ensure that the service provider is not liable for the information transmitted, on condition that the provider:
(a) does not initiate the transmission;
(b) does not select the receiver of the transmission; and
(c) does not select or modify the information contained in the transmission.
2. The acts of transmission and of provision of access referred to in paragraph 1 include the automatic, intermediate and transient storage of the information transmitted in so far as this takes place for the sole purpose of carrying out the transmission in the communication network, and provided that the information is not stored for any period longer than is reasonably necessary for the transmission.
3. This Article shall not affect the possibility for a court or administrative authority, in accordance with Member States' legal systems, of requiring the service provider to terminate or prevent an infringement.
Article 13
"Caching"
1. Where an information society service is provided that consists of the transmission in a communication network of information provided by a recipient of the service, Member States shall ensure that the service provider is not liable for the automatic, intermediate and temporary storage of that information, performed for the sole purpose of making more efficient the information's onward transmission to other recipients of the service upon their request, on condition that:
(a) the provider does not modify the information;
(b) the provider complies with conditions on access to the information;
(c) the provider complies with rules regarding the updating of the information, specified in a manner widely recognised and used by industry;
(d) the provider does not interfere with the lawful use of technology, widely recognised and used by industry, to obtain data on the use of the information; and
(e) the provider acts expeditiously to remove or to disable access to the information it has stored upon obtaining actual knowledge of the fact that the information at the initial source of the transmission has been removed from the network, or access to it has been disabled, or that a court or an administrative authority has ordered such removal or disablement.
2. This Article shall not affect the possibility for a court or administrative authority, in accordance with Member States' legal systems, of requiring the service provider to terminate or prevent an infringement.
Article 14
Hosting
1. Where an information society service is provided that consists of the storage of information provided by a recipient of the service, Member States shall ensure that the service provider is not liable for the information stored at the request of a recipient of the service, on condition that:
(a) the provider does not have actual knowledge of illegal activity or information and, as regards claims for damages, is not aware of facts or circumstances from which the illegal activity or information is apparent; or
(b) the provider, upon obtaining such knowledge or awareness, acts expeditiously to remove or to disable access to the information.
2. Paragraph 1 shall not apply when the recipient of the service is acting under the authority or the control of the provider.
3. This Article shall not affect the possibility for a court or administrative authority, in accordance with Member States' legal systems, of requiring the service provider to terminate or prevent an infringement, nor does it affect the possibility for Member States of establishing procedures governing the removal or disabling of access to information.
Article 15
No general obligation to monitor
1. Member States shall not impose a general obligation on providers, when providing the services covered by Articles 12, 13 and 14, to monitor the information which they transmit or store, nor a general obligation actively to seek facts or circumstances indicating illegal activity.
2. Member States may establish obligations for information society service providers promptly to inform the competent public authorities of alleged illegal activities undertaken or information provided by recipients of their service or obligations to communicate to the competent authorities, at their request, information enabling the identification of recipients of their service with whom they have storage agreements.
CHAPTER III
IMPLEMENTATION
Article 16
Codes of conduct
1. Member States and the Commission shall encourage:
(a) the drawing up of codes of conduct at Community level, by trade, professional and consumer associations or organisations, designed to contribute to the proper implementation of Articles 5 to 15;
(b) the voluntary transmission of draft codes of conduct at national or Community level to the Commission;
(c) the accessibility of these codes of conduct in the Community languages by electronic means;
(d) the communication to the Member States and the Commission, by trade, professional and consumer associations or organisations, of their assessment of the application of their codes of conduct and their impact upon practices, habits or customs relating to electronic commerce;
(e) the drawing up of codes of conduct regarding the protection of minors and human dignity.
2. Member States and the Commission shall encourage the involvement of associations or organisations representing consumers in the drafting and implementation of codes of conduct affecting their interests and drawn up in accordance with paragraph 1(a). Where appropriate, to take account of their specific needs, associations representing the visually impaired and disabled should be consulted.
Article 17
Out-of-court dispute settlement
1. Member States shall ensure that, in the event of disagreement between an information society service provider and the recipient of the service, their legislation does not hamper the use of out-of-court schemes, available under national law, for dispute settlement, including appropriate electronic means.
2. Member States shall encourage bodies responsible for the out-of-court settlement of, in particular, consumer disputes to operate in a way which provides adequate procedural guarantees for the parties concerned.
3. Member States shall encourage bodies responsible for out-of-court dispute settlement to inform the Commission of the significant decisions they take regarding information society services and to transmit any other information on the practices, usages or customs relating to electronic commerce.
Article 18
Court actions
1. Member States shall ensure that court actions available under national law concerning information society services' activities allow for the rapid adoption of measures, including interim measures, designed to terminate any alleged infringement and to prevent any further impairment of the interests involved.
2. The Annex to Directive 98/27/EC shall be supplemented as follows:
"11. Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects on information society services, in particular electronic commerce, in the internal market (Directive on electronic commerce) (OJ L 178, 17.7.2000, p. 1)."
Article 19
Cooperation
1. Member States shall have adequate means of supervision and investigation necessary to implement this Directive effectively and shall ensure that service providers supply them with the requisite information.
2. Member States shall cooperate with other Member States; they shall, to that end, appoint one or several contact points, whose details they shall communicate to the other Member States and to the Commission.
3. Member States shall, as quickly as possible, and in conformity with national law, provide the assistance and information requested by other Member States or by the Commission, including by appropriate electronic means.
4. Member States shall establish contact points which shall be accessible at least by electronic means and from which recipients and service providers may:
(a) obtain general information on contractual rights and obligations as well as on the complaint and redress mechanisms available in the event of disputes, including practical aspects involved in the use of such mechanisms;
(b) obtain the details of authorities, associations or organisations from which they may obtain further information or practical assistance.
5. Member States shall encourage the communication to the Commission of any significant administrative or judicial decisions taken in their territory regarding disputes relating to information society services and practices, usages and customs relating to electronic commerce. The Commission shall communicate these decisions to the other Member States.
Article 20
Sanctions
Member States shall determine the sanctions applicable to infringements of national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are enforced. The sanctions they provide for shall be effective, proportionate and dissuasive.
CHAPTER IV
FINAL PROVISIONS
Article 21
Re-examination
1. Before 17 July 2003, and thereafter every two years, the Commission shall submit to the European Parliament, the Council and the Economic and Social Committee a report on the application of this Directive, accompanied, where necessary, by proposals for adapting it to legal, technical and economic developments in the field of information society services, in particular with respect to crime prevention, the protection of minors, consumer protection and to the proper functioning of the internal market.
2. In examining the need for an adaptation of this Directive, the report shall in particular analyse the need for proposals concerning the liability of providers of hyperlinks and location tool services, "notice and take down" procedures and the attribution of liability following the taking down of content. The report shall also analyse the need for additional conditions for the exemption from liability, provided for in Articles 12 and 13, in the light of technical developments, and the possibility of applying the internal market principles to unsolicited commercial communications by electronic mail.
Article 22
Transposition
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 17 January 2002. They shall forthwith inform the Commission thereof.
2. When Member States adopt the measures referred to in paragraph 1, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such reference shall be laid down by Member States.
Article 23
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 24
Addressees
This Directive is addressed to the Member States.
|
[
"UKSI20022013"
] |
32000L0041
|
2000
|
Commission Directive 2000/41/EC of 19 June 2000 postponing for a second time the date after which animal tests are prohibited for ingredients or combinations of ingredients of cosmetic products (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products(1), as last amended by Commission Directive 2000/11/EC(2), and in particular Article 4(1)(i) thereof,
After consulting the Scientific Committee on cosmetic products and non-food products intended for consumers,
Whereas:
(1) The main objective of Directive 76/768/EEC is to protect public health. To this end it is indispensable to carry out certain toxicological tests to evaluate the safety for human health of ingredients and combinations of ingredients used in cosmetic products.
(2) Pursuant to Article 4(1)(i) of Directive 76/768/EEC Member States should prohibit the marketing of cosmetic products containing ingredients or combinations of ingredients tested on animals after 30 June 2000 in order to meet the requirements of the Directive.
(3) The second subparagraph of this provision also provides that the Commission should submit draft measures to postpone the date of implementation of this provision if there has been insufficient progress in developing satisfactory methods to replace animal testing, and in particular in those cases where alternative methods of testing, despite all reasonable endeavours, have not been scientifically validated as offering an equivalent level of protection for the consumer, taking into account OECD toxicity test guidelines.
(4) In the absence of any scientifically validated alternative methods to animal experiments and any pertinent toxicity test guidelines in the field of alternative methods adopted by the OECD, it was necessary to postpone the date provided for in Article 4(1)(i) of Directive 76/768/EEC for the first time by Commission Directive 97/18/EC in compliance with the second subparagraph of this provision.
(5) Three alternative methods have been validated in Europe to date. It is unlikely that the scientific state of the art will change significantly before 30 June 2000. Therefore, the date provided for in Article 4(1)(i) of Directive 76/768/EEC should be postponed for a second time in compliance with the second subparagraph of this provision and Article 2 of Directive 97/18/EC.
(6) These three methods are being incorporated into Community law through their entry onto Annex V to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(3), as last amended by Commission Directive 2000/33/EC(4).
(7) Council Directive 86/609/EEC(5) of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(6) provides that an animal test shall not be carried out if an alternative method is available.
(8) These methods are therefore mandatory for use in all sectors including that of cosmetics.
(9) The Commission has proposed a Directive amending for the seventh time Directive 76/768/EEC in order to solve definitively the issue of experiments on animals in the cosmetic products sector. Such a proposal should be adopted by co-decision procedure involving the European Parliament and the Council.
(10) Taking into account that it can be expected that validated alternative methods will become available for other tests in the next two years and that the proposed Directive shall be adopted by that point of time, it is appropriate to postpone for the last time the date to 30 June 2002.
(11) The measures provided for in this Directive are in accordance with the opinion of the Committee on the adaptation to technical progress of the Directives on the removal of technical barriers to trade in the cosmetic products sector,
Article 1
The date of "30 June 2000" shall be replaced by "30 June 2002" in the first sentence of Article 4(1)(i) of Directive 76/768/EEC.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 29 June 2000 at the latest. They shall forthwith inform the Commission thereof.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the third day following that of its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
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[
"UKSI20001679"
] |
32000L0042
|
2000
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Commission Directive 2000/42/EC of 22 June 2000 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(1), as last amended by Commission Directive 2000/24/EC(2), and in particular Article 10 thereof,
Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin(3), as last amended by Directive 2000/24/EC, and in particular Article 10 thereof,
Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on products of plant origin, including fruit and vegetables(4), as last amended by Directive 2000/24/EC, and in particular Article 7 thereof,
Whereas:
(1) Council Directives 94/29/EC(5) and 94/30/EC(6), in fixing maximum residue levels in the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC for benalaxyl, benfuracarb, carbofuran, carbosulfan, cyfluthrin, ethephon, fenarimol, furathiocarb, lambda-cyhalothrin, metalaxyl and propiconazole provided that for many commodities, the maximum residue levels would automatically revert to the appropriate lower limits of analytical determination unless other levels were adopted before 30 June 1999. This deadline was amended to read "at the latest by 1 July 2000" by Commission Directive 97/71/EC(7).
(2) Council Directives 95/38/EC(8) and 95/39/EC(9), in fixing maximum residue levels in the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC for aldicarb, amitraz, methidathion, methomyl, thiodicarb, pirimiphos-methyl and thiabendazole provided that for many commodities, the maximum residue levels would automatically revert to the appropriate lower limits of analytical determination unless other levels were adopted before 1 July 2000.
(3) Council Directives 96/32/EC(10) and 96/33/EC(11), in fixing maximum residue levels in the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC for chlormequat, diazonon, dicofol, disulfoton, endosulfan, fenbutatin oxide, mecarbam, phorate, propoxur, propyzamide, triazophos, and triforine provided that for many commodities, the maximum residue levels would automatically revert to the appropriate lower limits of analytical determination unless other levels were adopted before 30 April 2000. This deadline was amended to read "at the latest by 1 July 2000" by Directive 97/71/EC.
(4) Commission Directive 98/82/EC(12) in fixing maximum residue levels in the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC for benomyl, carbendazim, thiophanate methyl, chlorothalonil, fenvalerate (including other mixtures of constituents), acephate and quinalphos provided that for many commodities, the maximum residue levels would automatically revert to the appropriate lower limits of analytical determination unless other levels were adopted before 1 July 2000.
(5) The above positions in the Annexes to the Directives were left "open", or were fixed on a temporary basis, because there was insufficient data available, at the dates of their adoption, to justify the fixing of maximum residue limits at Community level. The objective of fixing the said deadline was to provide interested parties with sufficient time to provide the necessary data enabling, where appropriate and justified, the adoption of maximum residue levels at Community level above the lower limit of analytical determination. Interested parties were notified of the deadline. For many open positions additional data has been provided permitting the fixing of maximum residue levels. Where no additional data has been provided, it is appropriate to fix maximum residue levels at the lower limit of analytical determination.
(6) Requests, supported by further data, were received from Community trading partners to grant greater tolerances for some of these pesticides for positions where Community maximum residue levels had already been fixed in the Annexes to the base Directives.
(7) The information available has been reviewed. For many positions the data is sufficient to fix residue level above the lower limit of analytical determination and it is appropriate to do so. For some positions the information available is inadequate and it is appropriate to fix maximum residue levels at the lower limit of analytical determination. For other positions the information is adequate but demonstrates that the setting of a maximum residue level above the lower limit of analytical determination may give rise to an unacceptable acute or chronic exposure of the consumer to the residues. In such cases, it is appropriate to fix maximum residue levels at the lower limit of analytical determination.
(8) Commission Decision 98/270/EC of 7 April 1998 concerning the withdrawal of authorisations of plant protection products containing fenvalerate as an active substance(13) obliged Member States to withdraw authorisations of fenvalerate as a plant protection product by 7 April 1999. The use of esfenvalerate remains authorised. Since the current description "Fenvalerate including other mixtures of constituents" of the residue in the Annexes to Directives 86/362/EEC, 86/363/EEC, and 90/642/EEC does not distinguish between residues arising from the use of fenvalerate and those arising from the use of esfenvalerate, it is appropriate to modify the residue definition and the maximum level to reflect the permitted continued use of esfenvalerate and the prohibition on the use of fenvalerate.
(9) The lifetime exposure of consumers to these pesticides via food products that may contain residues of these pesticides has been assessed and evaluated in accordance with the procedures and practices used within the European Community taking account of guidelines published by the World Health Organisation(14) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceedence of the acceptable daily intakes.
(10) The acute exposure of consumers to these pesticides via each of the food products that may contain residues of these pesticides has been assessed and evaluated in accordance with the procedures and practices used within the European Community, taking account of guidelines published by the World Health Organisation. It has been calculated that the maximum residue levels fixed for open positions in the present Directive do not give rise to acute toxic effects.
(11) To ensure that the consumer is adequately protected from exposure to residues in or on products for which no authorisations have been granted, it is prudent to set maximum residue levels at the lower limit of analytical determination for all such products covered by Directives 86/362/EEC, 86/363/EEC and 90/642/EEC.
(12) The Community's trading partners have been consulted about the levels set out in this Directive through the World Trade Organisation and their comments on these levels have been considered.
(13) The opinions of the Scientific Committee for Plants, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides, have been taken into account. The methodology described by the World Health Organisation, referred to above, as applied by rapporteur member states, checked and evaluated by the Commission in the framework of the Standing Committee on Plant Health, is in agreement with the guidance given by the Scientific Committee of Plants(15).
(14) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,
Article 1
The maximum levels for residues listed in Annex I to this Directive shall replace those listed in Part A of Annex II to Directive 86/362/EEC for the pesticides in question.
Article 2
1. The maximum levels for residues listed in Annex II to this Directive shall replace those listed in Part A of Annex II to Directive 86/363/EEC for the pesticides in question.
2. The maximum levels for residues listed in Annex III to this Directive shall replace those listed in Part B of Annex II to Directive 86/363/EEC for the pesticides in question.
Article 3
1. The maximum levels for residues listed in Annex IV to this Directive shall replace those listed in Annex II to Directive 90/642/EEC for the pesticides in question.
2. The maximum level for residues for acephate on peaches shall be fixed at 0,02(16) mg/kg.
Article 4
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 28 February 2001 at the latest. They shall forthwith inform the Commission thereof.
They shall apply these measures as of 1 July 2001.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 5
This Directive shall enter into force on the first day following that of its publication in the Official Journal of the European Communities.
Article 6
This Directive is addressed to the Member States.
|
[
"UKSI20011113"
] |
32000L0034
|
2000
|
Directive 2000/34/EC of the European Parliament and of the Council of 22 June 2000 amending Council Directive 93/104/EC concerning certain aspects of the organisation of working time to cover sectors and activities excluded from that Directive
Having regard to the Treaty establishing the European Community, and in particular Article 137(2) thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), in the light of the joint text approved by the Conciliation Committee on 3 April 2000,
Whereas:
(1) Article 137 of the Treaty provides that the Community is to support and complement the activities of the Member States with a view to improving the working environment to protect workers' health and safety. Directives adopted on the basis of that Article are to avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings.
(2) Council Directive 93/104/EC of 23 November 1993 concerning certain aspects of the organisation of working time(4) lays down minimum safety and health requirements for the organisation of working time, in respect of periods of daily rest, breaks, weekly rest, maximum weekly working time, annual leave and aspects of night work, shift work and patterns of work. That Directive should be amended for the following reasons.
(3) Road, air, sea and rail transport, inland waterways, sea fishing, other work at sea and the activities of doctors in training are excluded from the scope of Council Directive 93/104/EC.
(4) The Commission, in its proposal of 20 September 1990, did not exclude any sectors and activities from Council Directive 93/104/EC, nor did the European Parliament in its Opinion of 20 February 1991 accept such exclusions.
(5) The health and safety of workers should be protected at the workplace not because they work in a particular sector or carry out a particular activity, but because they are workers.
(6) As regards sectoral legislation for mobile workers, a complementary and parallel approach is needed in the provisions on transport safety and the health and safety of the workers concerned.
(7) Account needs to be taken of the specific nature of activities at sea and of doctors in training.
(8) Protection of the health and safety of mobile workers in the excluded sectors and activities should also be guaranteed.
(9) The existing provisions concerning annual leave and health assessments for night work and shift work should be extended to include mobile workers in the excluded sectors and activities.
(10) The existing provisions on working time and rest need to be adapted for mobile workers in the excluded sectors and activities.
(11) All workers should have adequate rest periods. The concept of "rest" must be expressed in units of time, i.e. in days, hours and/or fractions thereof.
(12) A European Agreement in respect of the working time of seafarers has been put into effect by means of a Council Directive(5), on a proposal from the Commission, in accordance with Article 139(2) of the Treaty. Accordingly, the provisions of this Directive should not apply to seafarers.
(13) In the case of those "share-fishermen" who are employees, it is for Member States to determine, pursuant to Article 7 of Council Directive 93/104/EC, the conditions for entitlement to, and granting of, annual leave, including the arrangements for payments.
(14) Specific standards laid down in other Community instruments relating, for example, to rest periods, working time, annual leave and night work for certain categories of workers should take precedence over the provisions of Council Directive 93/104/EC as amended by this Directive.
(15) In the light of the case law of the Court of Justice of the European Communities the provision relating to Sunday rest should be deleted.
(16) In its judgment in Case C-84/94 United Kingdom v. Council(6) the Court of Justice ruled that Council Directive 93/104/EC accords with the principles of subsidiarity and proportionality set out in Article 5 of the Treaty. There is no reason to assume that that judgment is not applicable to comparable rules concerning a number of aspects of the organisation of working time in excluded sectors and activities,
Article 1
Directive 93/104/EC is hereby amended as follows:
1. Article 1(3) shall be replaced by the following:
"3. This Directive shall apply to all sectors of activity, both public and private, within the meaning of Article 2 of Directive 89/391/EEC, without prejudice to Articles 14 and 17 of this Directive.
This Directive shall not apply to seafarers, as defined in Council Directive 1999/63/EC of 21 June 1999 concerning the Agreement on the organisation of working time of seafarers, concluded by the European Community Shipowners' Association (ECSA) and the Federation of Transport Workers' Unions in the European Union (FST)(7) without prejudice to Article 2(8) of this Directive.";
2. in Article 2, the following shall be added:
"7. 'mobile worker' shall mean any worker employed as a member of travelling or flying personnel by an undertaking which operates transport services for passengers or goods by road, air or inland waterway.
8. 'offshore work' shall mean work performed mainly on or from offshore installations (including drilling rigs), directly or indirectly in connection with the exploration, extraction or exploitation of mineral resources, including hydrocarbons, and diving in connection with such activities, whether performed from an offshore installation or a vessel.
9. 'adequate rest' shall mean that workers have regular rest periods, the duration of which is expressed in units of time and which are sufficiently long and continuous to ensure that, as a result of fatigue or other irregular working patterns, they do not cause injury to themselves, to fellow workers or to others and that they do not damage their health, either in the short term or in the longer term.";
3. In Article 5, the following subparagraph shall be deleted:"The minimum rest period referred to in the first subparagraph shall in principle include Sunday."
4. Article 14 shall be replaced by the following:
"Article 14
More specific Community provisions
This Directive shall not apply where other Community instruments contain more specific requirements relating to the organisation of working time for certain occupations or occupational activities."
5. Article 17(2.1) shall be replaced by the following:
"2.1. from Articles 3, 4, 5, 8 and 16:
(a) in the case of activities where the worker's place of work and his place of residence are distant from one another, including offshore work, or where the worker's different places of work are distant from one another;
(b) in the case of security and surveillance activities requiring a permanent presence in order to protect property and persons, particularly security guards and caretakers or security firms;
(c) in the case of activities involving the need for continuity of service or production, particularly:
(i) services relating to the reception, treatment and/or care provided by hospitals or similar establishments, including the activities of doctors in training, residential institutions and prisons;
(ii) dock or airport workers;
(iii) press, radio, television, cinematographic production, postal and telecommunications services, ambulance, fire and civil protection services;
(iv) gas, water and electricity production, transmission and distribution, household refuse collection and incineration plants;
(v) industries in which work cannot be interrupted on technical grounds;
(vi) research and development activities;
(vii) agriculture;
(viii) workers concerned with the carriage of passengers on regular urban transport services;
(d) where there is a foreseeable surge of activity, particularly in:
(i) agriculture;
(ii) tourism;
(iii) postal services;
(e) in the case of persons working in railway transport:
(i) whose activities are intermittent;
(ii) who spend their working time on board trains; or
(iii) whose activities are linked to transport timetables and to ensuring the continuity and regularity of traffic.".
6. In Article 17(2) the following shall be added:
"2.4. from Articles 6 and 16(2) in the case of doctors in training:
(a) with respect to Article 6, for a transitional period of five years from 1 August 2004.
(i) Member States may have up to two more years, if necessary, to take account of difficulties in meeting the working time provisions with respect to their responsibilities for the organisation and delivery of health services and medical care. At least six months before the end of the transitional period, the Member State concerned shall inform the Commission giving its reasons, so that the Commission can give an opinion, after appropriate consultations, within the three months following receipt of such information. If the Member State does not follow the opinion of the Commission, it will justify its decision. The notification and justification of the Member State and the opinion of the Commission shall be published in the Official Journal of the European Communities and forwarded to the European Parliament.
(ii) Member States may have an additional period of up to one year, if necessary, to take account of special difficulties in meeting the abovementioned responsibilities. They shall follow the procedure set out in paragraph (i).
Within the context of the transitional period:
(iii) Member States shall ensure that in no case will the number of weekly working hours exceed an average of 58 during the first three years of the transitional period, an average of 56 for the following two years and an average of 52 for any remaining period.
(iv) The employer shall consult the representatives of the employees in good time with a view to reaching an agreement, wherever possible, on the arrangements applying to the transitional period. Within the limits set out in point (iii), such an agreement may cover:
- the average number of weekly hours of work during the transitional period; and
- the measures to be adopted to reduce weekly working hours to an average of 48 by the end of the transitional period;
(b) with respect to Article 16(2), provided that the reference period does not exceed 12 months, during the first part of the transitional period specified in paragraph (a) (iii), and six months thereafter.";
7. The following Articles shall be inserted:
"Article 17a
Mobile workers and offshore work
1. Articles 3, 4, 5 and 8 shall not apply to mobile workers.
2. Member States shall, however, take the necessary measures to ensure that such mobile workers are entitled to adequate rest, except in the circumstances laid down in Article 17(2.2).
3. Subject to compliance with the general principles relating to the protection of the safety and health of workers, and provided that there is consultation of representatives of the employer and employees concerned and efforts to encourage all relevant forms of social dialogue, including negotiation if the parties so wish, Member States may, for objective or technical reasons or reasons concerning the organisation of work, extend the reference period referred to in Article 16(2) to twelve months in respect of workers who mainly perform offshore work.
4. On 1 August 2005 the Commission shall, after consulting the Member States and management and labour at European level, review the operation of the provisions with regard to offshore workers from a health and safety perspective with a view to presenting, if need be, the appropriate modifications.
Article 17b
Workers on board sea-going fishing vessels
1. Articles 3, 4, 5, 6 and 8 shall not apply to any worker on board a sea-going fishing vessel flying the flag of a Member State.
2. Member States shall, however, take the necessary measures to ensure that any worker on board a sea-going fishing vessel flying the flag of a Member State is entitled to adequate rest and to limit the number of hours of work to 48 hours a week on average calculated over a reference period not exceeding 12 months.
3. Within the limits set out in paragraphs 2, 4 and 5 Member States shall take the necessary measures to ensure that, in keeping with the need to protect the safety and health of such workers,
(a) the working hours are limited to a maximum number of hours which shall not be exceeded in a given period of time, or
(b) a minimum number of hours of rest are provided within a given period of time.
The maximum number of hours of work or minimum number of hours of rest shall be specified by law, regulations, administrative provisions or by collective agreements or agreements between the two sides of the industry.
4. The limits on hours of work or rest shall be either:
(a) maximum hours of work which shall not exceed:
(i) 14 hours in any 24-hour period, and
(ii) 72 hours in any seven-day period;
or
(b) minimum hours of rest which shall not be less than:
(i) 10 hours in any 24-hour period, and
(ii) 77 hours in any seven-day period.
5. Hours of rest may be divided into no more than two periods, one of which shall be at least six hours in length, and the interval between consecutive periods of rest shall not exceed 14 hours.
6. In accordance with the general principles of the protection of the health and safety of workers, and for objective or technical reasons or reasons concerning the organisation of work, Member States may allow exceptions, including the establishment of reference periods, to the limits laid down in paragraphs 2, 4 and 5. Such exceptions shall, as far as possible, comply with the standards laid down but may take account of more frequent or longer leave periods or the granting of compensatory leave for the workers. These exceptions may be laid down by means of
(i) laws, regulations or administrative provisions provided there is consultation, where possible, of the representatives of the employers and workers concerned and efforts are made to encourage all relevant forms of social dialogue, or
(ii) collective agreements or agreements between the two sides of industry.
7. The master of a sea-going fishing vessel shall have the right to require workers on board to perform any hours of work necessary for the immediate safety of the vessel, persons on board or cargo, or for the purpose of giving assistance to other vessels or persons in distress at sea.
8. Members States may provide that workers on board sea-going fishing vessels for which national legislation or practice determines that these vessels are not allowed to operate in a specific period of the calendar year exceeding one month, shall take annual leave in accordance with Article 7 within the abovementioned period."
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 1 August 2003, or shall ensure that, by that date at the latest, the two sides of industry have introduced the necessary measures by agreement, the Member States being required to take any necessary measure to enable them at any time to be in a position to guarantee the results imposed by this Directive. With regard to doctors in training that date shall be 1 August 2004. They shall forthwith inform the Commission thereof.
2. When Member States adopt the measures referred to in paragraph 1, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
3. Without prejudice to the right of Member States to develop, in the light of changing circumstances, different legislative, regulatory or contractual provisions in the field of working time, as long as the minimum requirements provided for in this Directive are complied with, implementation of this Directive shall not constitute valid grounds for reducing the general level of protection afforded to workers.
4. Member States shall communicate to the Commission the texts of the provisions of national law already adopted or being adopted in the field governed by this Directive.
Article 3
Not later than 1 August 2009 the Commission shall, after consulting the Member States and management and labour at European level, review the operation of the provisions with regard to workers on board sea-going fishing vessels, and, in particular examine whether these provisions remain appropriate, in particular, as far as health and safety are concerned with a view to proposing suitable amendments, if necessary.
Article 4
Not later than 1 August 2005 the Commission shall, after consulting the Member States and management and labour at European level, review the operation of the provisions with regard to workers concerned with the carriage of passengers on regular urban transport services, with a view to presenting, if need be, the appropriate modifications to ensure a coherent and suitable approach in the sector.
Article 5
This Directive shall enter into force on the date of its publication in the Official Journal of the European Communities.
Article 6
This Directive is addressed to the Member States.
|
[
"UKSI20041713",
"UKSI20031684"
] |
32000L0036
|
2000
|
Directive 2000/36/EC of the European Parliament and of the Council of 23 June 2000 relating to cocoa and chocolate products intended for human consumption
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),
Whereas:
(1) Certain vertical Directives relating to foodstuffs should be simplified in order to take account only of the essential requirements to be met by the products they cover in order that those products may move freely within the internal market, in accordance with the conclusions of the European Council held in Edinburgh on 11 and 12 December 1992, confirmed by those of the European Council in Brussels on 10 and 11 December 1993.
(2) Council Directive 73/241/EEC of 24 July 1973 on the approximation of the laws of the Member States relating to cocoa and chocolate products intended for human consumption(4) was warranted by the fact that differences between national laws on several kinds of cocoa and chocolate products could hinder the free movement of this product, and thereby have a direct effect on the establishment and functioning of the common market.
(3) The aforesaid Directive was consequently designed to lay down definitions and common rules in respect of the composition, manufacturing specifications, packaging and labelling of cocoa and chocolate products so as to ensure their free movement within the Community.
(4) Those definitions and rules should be amended to take account of technological progress and changes in consumer tastes, and should be brought into line with general Community legislation on foodstuffs, in particular legislation on labelling, sweeteners and other authorised additives, flavourings, extraction solvents and methods of analysis.
(5) The addition to chocolate products of vegetable fats other than cocoa butter, up to a maximum of 5 %, is permitted in certain Member States.
(6) The addition of certain vegetable fats other than cocoa butter to chocolate products, up to a maximum of 5 %, should be permitted in all Member States; those vegetable fats should be cocoa butter equivalents and therefore be defined according to technical and scientific criteria.
(7) In order to guarantee the single nature of the internal market, all chocolate products covered by this Directive must be able to move within the Community under the sales names set out in the provisions of Annex I to this Directive.
(8) In pursuance of the general food-labelling rules set out in Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(5), in particular a listing of ingredients in accordance with Article 6 thereof is compulsory; this Directive makes Directive 79/112/EEC applicable to cocoa and chocolate products in order to provide consumers with correct information.
(9) In the case of chocolate products to which vegetable fats other than cocoa butter have been added, consumers should be guaranteed correct, neutral and objective information in addition to the list of ingredients.
(10) On the other hand, Directive 79/112/EEC does not preclude the labelling of chocolate products to indicate that vegetable fats other than cocoa butter have not been added, provided the information is correct, neutral, objective, and does not mislead the consumer.
(11) Certain sales names which are reserved by this Directive are in fact used in composite sales names which are recognised in certain Member States to describe products which could not be confused with those defined in this Directive; such descriptions should therefore be maintained. However, the use of such names should comply with the provisions of Directive 79/112/EEC and, in particular, with Article 5 thereof.
(12) The development of the internal market since the adoption of Directive 73/241/EEC enables "plain chocolate" to be treated on the same basis as "chocolate".
(13) The derogation provided for in Directive 73/241/EEC allowing the United Kingdom and Ireland to authorise the use on their territory of the name "milk chocolate" to designate "milk chocolate with high milk content" should be maintained; however, the English name "milk chocolate with high milk content" should be replaced with the name "family milk chocolate".
(14) Pursuant to the principle of proportionality, this Directive restricts itself to what is necessary in order to achieve the objectives of the Treaty, in accordance with the third paragraph of Article 5 thereof.
(15) Cocoa, cocoa butter and a series of other vegetable fats used in the manufacture of chocolate are mainly produced in developing countries. It is in the interests of people living in developing countries that agreements of as long a duration as possible should be concluded. The Commission should therefore consider how the Community can support this in the case of cocoa butter and other vegetable fats (for example by promoting "fair trade").
(16) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(6).
(17) To avoid creating new barriers to free circulation, Member States should refrain from adopting, for the products in question, national provisions not provided for by this Directive,
Article 1
This Directive shall apply to the cocoa and chocolate products intended for human consumption, as defined in Annex I.
Article 2
1. The vegetable fats other than cocoa butter as defined in Annex II and listed therein may be added to those chocolate products defined in Annex I(A)(3), (4), (5), (6), (8) and (9). That addition may not exceed 5 % of the finished product, after deduction of the total weight of any other edible matter used in accordance with Annex I(B), without reducing the minimum content of cocoa butter or total dry cocoa solids.
2. Chocolate products which, pursuant to paragraph 1, contain vegetable fats other than cocoa butter may be marketed in all of the Member States, provided that their labelling, as provided for in Article 3, is supplemented by a conspicuous and clearly legible statement: "contains vegetable fats in addition to cocoa butter". This statement shall be in the same field of vision as the list of ingredients, clearly separated from that list, in lettering at least as large and in bold with the sales name nearby; notwithstanding this requirement, the sales name may also appear elsewhere.
3. Any amendments to Annex II shall be made in accordance with the procedure laid down in Article 95 of the Treaty.
4. At the latest by 3 February 2006 the Commission shall, in accordance with Article 95 of the Treaty, submit, if necessary and taking into account the results of an appropriate study on this Directive's impact on the economies of those countries producing cocoa and vegetable fats other than cocoa butter, a proposal intended to amend the list in Annex II.
Article 3
Directive 79/112/EEC shall apply to the products defined in Annex I, subject to the following conditions:
1. The sales names listed in Annex I shall apply only to the products referred to therein and must be used in trade to designate them.
However, those sales names may also be used additionally and in accordance with the provisions or customs applicable in the Member State in which the product is sold to the final consumer, to designate other products which cannot be confused with those defined in Annex I.
2. Where the products defined in Annex I(A)(3), (4), (5), (6), (7) and (10) are sold in assortments, the sales names may be replaced by "assorted chocolates" or "assorted filled chocolates" or similar names. In that case, there may be a single list of ingredients for all the products in the assortment.
3. The labelling of the cocoa and chocolate products defined in Annex I(A)(2)(c), (2)(d), (3), (4), (5), (8) and (9) must indicate the total dry cocoa solids content by including the words: "cocoa solids:... % minimum".
4. For the products referred to in Annex I(A)(2)(b) and (2)(d) (second part of the sentence), the labelling must indicate the cocoa butter content.
5. The sales names "chocolate", "milk chocolate" and "couverture chocolate" specified in Annex I may be supplemented by information or descriptions relating to quality criteria provided that the products contain:
- in the case of chocolate, not less than 43 % total dry cocoa solids, including not less than 26 % cocoa butter,
- in the case of milk chocolate, not less than 30 % total dry cocoa solids and not less than 18 % dry milk solids obtained by partly or wholly dehydrating whole milk, semi- or full-skimmed milk, cream, or from partly or wholly dehydrated cream, butter or milk fat, including not less than 4,5 % milk fat,
- in the case of couverture chocolate, not less than 16 % of dry non-fat cocoa solids.
Article 4
For the products defined in Annex I, Member States shall not adopt national provisions not provided for by this Directive.
Article 5
1. The measures necessary for the implementation of this Directive relating to the matters referred to below shall be adopted in accordance with the regulatory procedure referred to in Article 6(2):
- bringing this Directive into line with general Community provisions applicable to foodstuffs,
- adaptation of the provisions in Annex I(B)(2), (C) and (D) to technical progress.
2. At the latest by 3 August 2003, without prejudice to Article 2(3), the European Parliament and the Council shall re-examine, on a proposal from the Commission, the second indent of paragraph 1 of this Article, with a view to possible extension of the procedure of adaptation to technical and scientific progress.
Article 6
1. The Commission shall be assisted by the Standing Committee on Foodstuffs, set up by Council Decision 69/414/EEC(7), hereinafter referred to as "the Committee".
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The Committee shall adopt its Rules of Procedure.
Article 7
Council Directive 73/241/EEC is hereby repealed with effect from 3 August 2003.
References to the repealed Directive shall be construed as references to this Directive.
Article 8
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 3 August 2003. They shall immediately inform the Commission thereof.
2. These measures shall be applied so as to:
- authorise the marketing of the products defined in Annex I if they conform to the definitions and rules laid down in this Directive, with effect from 3 August 2003,
- prohibit the marketing of products which fail to conform to this Directive, with effect from 3 August 2003.
However, the marketing of products failing to comply with this Directive but labelled before 3 August 2003 in accordance with Council Directive 73/241/EEC shall be permitted until stocks are exhausted.
3. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
Article 9
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 10
This Directive is addressed to the Member States.
|
[
"UKSI20031659"
] |
32000L0040
|
2000
|
Directive 2000/40/EC of the European Parliament and of the Council of 26 June 2000 on the approximation of the laws of the Member States relating to the front underrun protection of motor vehicles and amending Council Directive 70/156/EEC
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),
Whereas:
(1) By Decision 97/836/EC(4), the Council, with the assent of the European Parliament, authorised the Community to accede to the Agreement of the United Nations Economic Commission for Europe (ECE) concerning the adoption of uniform technical prescriptions for wheeled vehicles, equipment and parts which can be fitted to and/or be used on wheeled vehicles and the conditions for reciprocal recognition of approvals granted on the basis of these prescriptions, done at Geneva on 20 March 1958, as revised on 16 October 1995.
(2) Through its accession to the said Agreement, the Community subscribed to a defined list of Regulations established pursuant to that Agreement. This list includes UN/ECE Regulation No 93(5).
(3) In order to reduce the number of European road accident casualties, it is necessary to introduce without delay the measures established by UNE/ECE Regulation No 93 into the EC type-approval procedure set up by Council Directive 70/156/EEC(6), so as to improve the protection of the occupants of passenger cars and light vans from injury in the event of a collision with the front of heavy goods vehicles and to allow manufacturers of such devices and of vehicles equipped with such devices to obtain an EC type-approval if they meet the technical requirements of that Regulation.
(4) In accordance with the principles of subsidiarity and proportionality as set out in Article 5 of the Treaty, the objectives of this Directive cannot be sufficiently achieved by the Member States on account of the scale and effect of the action proposed in the relevant sector, and can therefore be better achieved by the Community. This Directive does not go beyond what is necessary for the attainment of its objective, namely EC type-approval.
(5) This Directive is one of the separate directives which must be complied with in order to conform to the EC type-approval procedure. Consequently, the provisions laid down in Directive 70/156/EEC relating to vehicles, vehicle systems, components and separate technical units apply to this Directive.
(6) In view of the considerable number of road accidents involving commercial vehicles having a mass of more than 3,5 tonnes, and consequently in order to increase road safety, the provisions concerning such vehicles should be made mandatory by this Directive without awaiting any further supplements to EC type-approval for this category of vehicles.
(7) Directive 70/156/EEC should be amended in consequence,
Article 1
For the purposes of this Directive:
(a) "vehicle" means any motor vehicle as defined in Section A of Annex II to Directive 70/156/EEC;
(b) "front underrun protective device" means a front underrun protective device which is intended to be part of a vehicle and which can be approved as a separate technical unit in accordance with Article 2 of Directive 70/156/EEC.
Article 2
1. With effect from 10 August 2001 or, if the publication referred to in Article 3 is delayed beyond 10 February 2001, six months after the date of the said publication, Member States may not, on grounds relating to the front underrun protection of a vehicle:
(a) refuse, in respect of a type of vehicle, or a type of a front underrun protective device considered as a separate technical unit, to grant EC type-approval or national type-approval; or
(b) prohibit the registration, sale or entry into service of vehicles or front underrun protective devices considered as a separate technical unit;
if the vehicles or separate technical units comply with the requirements of this Directive.
2. With effect from 10 August 2003, Member States:
(a) shall no longer grant EC type-approval or national type-approval for a type of vehicle or a type of front underrun protective device as a separate technical unit;
(b) shall refuse the registration, sale or entry into service of new vehicles or new front underrun protective devices as separate technical units;
on grounds relating to the front underrun protection if the requirements of this Directive are not complied with.
3. The administrative provisions governing EC type-approval shall be as set out in Annex I.
The scope of this Directive, and the technical requirements to be fulfilled for the award of EC type-approval, shall be as laid down in Annex II.
Article 3
Regulation No 93 of the United Nations Economic Commission for Europe shall be published in the Official Journal of the European Communities before 10 February 2001.
Article 4
Directive 70/156/EEC is amended as follows:
1. Annex I shall be amended as follows:
(a) Item 2.3.4 shall be replaced by the following:
"2.3.4. Width of the foremost axle (measured at the outermost part of the tyres excluding the bulging of the tyres close to the ground): ...".
(b) The following items shall be inserted:
"9.22. Front underrun protection
9.22.1. Drawing of the vehicle parts relevant to the front underrun protection, i.e. drawing of the vehicle and/or chassis with position and mounting of the widest front axle, drawing of the mounting and/or fitting of the front underrun protection. If the underrun protection is no special device, the drawing must clearly show that the required dimensions are met: ...
9.22.2. In the case of special device, full description and/or drawing of the front underrun protection (including mountings and fittings), or, if approved as a separate technical unit, type-approval number: ...".
2. Annex V shall be amended as follows:
(a) In Part I, the following item shall be added:
">TABLE>"
(b) In Part II, the following item shall be added:
">TABLE>"
Article 5
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 10 August 2001. However, if the publication referred to in Article 3 is delayed beyond 10 February 2001, Member States shall fulfil this obligation within six months of the said publication. They shall forthwith inform the Commission thereof.
Member States shall apply these measures as from 10 August 2001 or, if the publication referred to in Article 3 is delayed beyond 10 February 2001, six months after the said publication.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field governed by this Directive.
Article 6
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 7
This Directive is addressed to the Member States.
|
[
"UKSI20002730"
] |
32000L0043
|
2000
|
Council Directive 2000/43/EC of 29 June 2000 implementing the principle of equal treatment between persons irrespective of racial or ethnic origin
Having regard to the Treaty establishing the European Community and in particular Article 13 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the European Parliament(2),
Having regard to the opinion of the Economic and Social Committee(3),
Having regard to the opinion of the Committee of the Regions(4),
Whereas:
(1) The Treaty on European Union marks a new stage in the process of creating an ever closer union among the peoples of Europe.
(2) In accordance with Article 6 of the Treaty on European Union, the European Union is founded on the principles of liberty, democracy, respect for human rights and fundamental freedoms, and the rule of law, principles which are common to the Member States, and should respect fundamental rights as guaranteed by the European Convention for the protection of Human Rights and Fundamental Freedoms and as they result from the constitutional traditions common to the Member States, as general principles of Community Law.
(3) The right to equality before the law and protection against discrimination for all persons constitutes a universal right recognised by the Universal Declaration of Human Rights, the United Nations Convention on the Elimination of all forms of Discrimination Against Women, the International Convention on the Elimination of all forms of Racial Discrimination and the United Nations Covenants on Civil and Political Rights and on Economic, Social and Cultural Rights and by the European Convention for the Protection of Human Rights and Fundamental Freedoms, to which all Member States are signatories.
(4) It is important to respect such fundamental rights and freedoms, including the right to freedom of association. It is also important, in the context of the access to and provision of goods and services, to respect the protection of private and family life and transactions carried out in this context.
(5) The European Parliament has adopted a number of Resolutions on the fight against racism in the European Union.
(6) The European Union rejects theories which attempt to determine the existence of separate human races. The use of the term "racial origin" in this Directive does not imply an acceptance of such theories.
(7) The European Council in Tampere, on 15 and 16 October 1999, invited the Commission to come forward as soon as possible with proposals implementing Article 13 of the EC Treaty as regards the fight against racism and xenophobia.
(8) The Employment Guidelines 2000 agreed by the European Council in Helsinki, on 10 and 11 December 1999, stress the need to foster conditions for a socially inclusive labour market by formulating a coherent set of policies aimed at combating discrimination against groups such as ethnic minorities.
(9) Discrimination based on racial or ethnic origin may undermine the achievement of the objectives of the EC Treaty, in particular the attainment of a high level of employment and of social protection, the raising of the standard of living and quality of life, economic and social cohesion and solidarity. It may also undermine the objective of developing the European Union as an area of freedom, security and justice.
(10) The Commission presented a communication on racism, xenophobia and anti-Semitism in December 1995.
(11) The Council adopted on 15 July 1996 Joint Action (96/443/JHA) concerning action to combat racism and xenophobia(5) under which the Member States undertake to ensure effective judicial cooperation in respect of offences based on racist or xenophobic behaviour.
(12) To ensure the development of democratic and tolerant societies which allow the participation of all persons irrespective of racial or ethnic origin, specific action in the field of discrimination based on racial or ethnic origin should go beyond access to employed and self-employed activities and cover areas such as education, social protection including social security and healthcare, social advantages and access to and supply of goods and services.
(13) To this end, any direct or indirect discrimination based on racial or ethnic origin as regards the areas covered by this Directive should be prohibited throughout the Community. This prohibition of discrimination should also apply to nationals of third countries, but does not cover differences of treatment based on nationality and is without prejudice to provisions governing the entry and residence of third-country nationals and their access to employment and to occupation.
(14) In implementing the principle of equal treatment irrespective of racial or ethnic origin, the Community should, in accordance with Article 3(2) of the EC Treaty, aim to eliminate inequalities, and to promote equality between men and women, especially since women are often the victims of multiple discrimination.
(15) The appreciation of the facts from which it may be inferred that there has been direct or indirect discrimination is a matter for national judicial or other competent bodies, in accordance with rules of national law or practice. Such rules may provide in particular for indirect discrimination to be established by any means including on the basis of statistical evidence.
(16) It is important to protect all natural persons against discrimination on grounds of racial or ethnic origin. Member States should also provide, where appropriate and in accordance with their national traditions and practice, protection for legal persons where they suffer discrimination on grounds of the racial or ethnic origin of their members.
(17) The prohibition of discrimination should be without prejudice to the maintenance or adoption of measures intended to prevent or compensate for disadvantages suffered by a group of persons of a particular racial or ethnic origin, and such measures may permit organisations of persons of a particular racial or ethnic origin where their main object is the promotion of the special needs of those persons.
(18) In very limited circumstances, a difference of treatment may be justified where a characteristic related to racial or ethnic origin constitutes a genuine and determining occupational requirement, when the objective is legitimate and the requirement is proportionate. Such circumstances should be included in the information provided by the Member States to the Commission.
(19) Persons who have been subject to discrimination based on racial and ethnic origin should have adequate means of legal protection. To provide a more effective level of protection, associations or legal entities should also be empowered to engage, as the Member States so determine, either on behalf or in support of any victim, in proceedings, without prejudice to national rules of procedure concerning representation and defence before the courts.
(20) The effective implementation of the principle of equality requires adequate judicial protection against victimisation.
(21) The rules on the burden of proof must be adapted when there is a prima facie case of discrimination and, for the principle of equal treatment to be applied effectively, the burden of proof must shift back to the respondent when evidence of such discrimination is brought.
(22) Member States need not apply the rules on the burden of proof to proceedings in which it is for the court or other competent body to investigate the facts of the case. The procedures thus referred to are those in which the plaintiff is not required to prove the facts, which it is for the court or competent body to investigate.
(23) Member States should promote dialogue between the social partners and with non-governmental organisations to address different forms of discrimination and to combat them.
(24) Protection against discrimination based on racial or ethnic origin would itself be strengthened by the existence of a body or bodies in each Member State, with competence to analyse the problems involved, to study possible solutions and to provide concrete assistance for the victims.
(25) This Directive lays down minimum requirements, thus giving the Member States the option of introducing or maintaining more favourable provisions. The implementation of this Directive should not serve to justify any regression in relation to the situation which already prevails in each Member State.
(26) Member States should provide for effective, proportionate and dissuasive sanctions in case of breaches of the obligations under this Directive.
(27) The Member States may entrust management and labour, at their joint request, with the implementation of this Directive as regards provisions falling within the scope of collective agreements, provided that the Member States take all the necessary steps to ensure that they can at all times guarantee the results imposed by this Directive.
(28) In accordance with the principles of subsidiarity and proportionality as set out in Article 5 of the EC Treaty, the objective of this Directive, namely ensuring a common high level of protection against discrimination in all the Member States, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and impact of the proposed action, be better achieved by the Community. This Directive does not go beyond what is necessary in order to achieve those objectives,
CHAPTER I
GENERAL PROVISIONS
Article 1
Purpose
The purpose of this Directive is to lay down a framework for combating discrimination on the grounds of racial or ethnic origin, with a view to putting into effect in the Member States the principle of equal treatment.
Article 2
Concept of discrimination
1. For the purposes of this Directive, the principle of equal treatment shall mean that there shall be no direct or indirect discrimination based on racial or ethnic origin.
2. For the purposes of paragraph 1:
(a) direct discrimination shall be taken to occur where one person is treated less favourably than another is, has been or would be treated in a comparable situation on grounds of racial or ethnic origin;
(b) indirect discrimination shall be taken to occur where an apparently neutral provision, criterion or practice would put persons of a racial or ethnic origin at a particular disadvantage compared with other persons, unless that provision, criterion or practice is objectively justified by a legitimate aim and the means of achieving that aim are appropriate and necessary.
3. Harassment shall be deemed to be discrimination within the meaning of paragraph 1, when an unwanted conduct related to racial or ethnic origin takes place with the purpose or effect of violating the dignity of a person and of creating an intimidating, hostile, degrading, humiliating or offensive environment. In this context, the concept of harassment may be defined in accordance with the national laws and practice of the Member States.
4. An instruction to discriminate against persons on grounds of racial or ethnic origin shall be deemed to be discrimination within the meaning of paragraph 1.
Article 3
Scope
1. Within the limits of the powers conferred upon the Community, this Directive shall apply to all persons, as regards both the public and private sectors, including public bodies, in relation to:
(a) conditions for access to employment, to self-employment and to occupation, including selection criteria and recruitment conditions, whatever the branch of activity and at all levels of the professional hierarchy, including promotion;
(b) access to all types and to all levels of vocational guidance, vocational training, advanced vocational training and retraining, including practical work experience;
(c) employment and working conditions, including dismissals and pay;
(d) membership of and involvement in an organisation of workers or employers, or any organisation whose members carry on a particular profession, including the benefits provided for by such organisations;
(e) social protection, including social security and healthcare;
(f) social advantages;
(g) education;
(h) access to and supply of goods and services which are available to the public, including housing.
2. This Directive does not cover difference of treatment based on nationality and is without prejudice to provisions and conditions relating to the entry into and residence of third-country nationals and stateless persons on the territory of Member States, and to any treatment which arises from the legal status of the third-country nationals and stateless persons concerned.
Article 4
Genuine and determining occupational requirements
Notwithstanding Article 2(1) and (2), Member States may provide that a difference of treatment which is based on a characteristic related to racial or ethnic origin shall not constitute discrimination where, by reason of the nature of the particular occupational activities concerned or of the context in which they are carried out, such a characteristic constitutes a genuine and determining occupational requirement, provided that the objective is legitimate and the requirement is proportionate.
Article 5
Positive action
With a view to ensuring full equality in practice, the principle of equal treatment shall not prevent any Member State from maintaining or adopting specific measures to prevent or compensate for disadvantages linked to racial or ethnic origin.
Article 6
Minimum requirements
1. Member States may introduce or maintain provisions which are more favourable to the protection of the principle of equal treatment than those laid down in this Directive.
2. The implementation of this Directive shall under no circumstances constitute grounds for a reduction in the level of protection against discrimination already afforded by Member States in the fields covered by this Directive.
CHAPTER II
REMEDIES AND ENFORCEMENT
Article 7
Defence of rights
1. Member States shall ensure that judicial and/or administrative procedures, including where they deem it appropriate conciliation procedures, for the enforcement of obligations under this Directive are available to all persons who consider themselves wronged by failure to apply the principle of equal treatment to them, even after the relationship in which the discrimination is alleged to have occurred has ended.
2. Member States shall ensure that associations, organisations or other legal entities, which have, in accordance with the criteria laid down by their national law, a legitimate interest in ensuring that the provisions of this Directive are complied with, may engage, either on behalf or in support of the complainant, with his or her approval, in any judicial and/or administrative procedure provided for the enforcement of obligations under this Directive.
3. Paragraphs 1 and 2 are without prejudice to national rules relating to time limits for bringing actions as regards the principle of equality of treatment.
Article 8
Burden of proof
1. Member States shall take such measures as are necessary, in accordance with their national judicial systems, to ensure that, when persons who consider themselves wronged because the principle of equal treatment has not been applied to them establish, before a court or other competent authority, facts from which it may be presumed that there has been direct or indirect discrimination, it shall be for the respondent to prove that there has been no breach of the principle of equal treatment.
2. Paragraph 1 shall not prevent Member States from introducing rules of evidence which are more favourable to plaintiffs.
3. Paragraph 1 shall not apply to criminal procedures.
4. Paragraphs 1, 2 and 3 shall also apply to any proceedings brought in accordance with Article 7(2).
5. Member States need not apply paragraph 1 to proceedings in which it is for the court or competent body to investigate the facts of the case.
Article 9
Victimisation
Member States shall introduce into their national legal systems such measures as are necessary to protect individuals from any adverse treatment or adverse consequence as a reaction to a complaint or to proceedings aimed at enforcing compliance with the principle of equal treatment.
Article 10
Dissemination of information
Member States shall take care that the provisions adopted pursuant to this Directive, together with the relevant provisions already in force, are brought to the attention of the persons concerned by all appropriate means throughout their territory.
Article 11
Social dialogue
1. Member States shall, in accordance with national traditions and practice, take adequate measures to promote the social dialogue between the two sides of industry with a view to fostering equal treatment, including through the monitoring of workplace practices, collective agreements, codes of conduct, research or exchange of experiences and good practices.
2. Where consistent with national traditions and practice, Member States shall encourage the two sides of the industry without prejudice to their autonomy to conclude, at the appropriate level, agreements laying down anti-discrimination rules in the fields referred to in Article 3 which fall within the scope of collective bargaining. These agreements shall respect the minimum requirements laid down by this Directive and the relevant national implementing measures.
Article 12
Dialogue with non-governmental organisations
Member States shall encourage dialogue with appropriate non-governmental organisations which have, in accordance with their national law and practice, a legitimate interest in contributing to the fight against discrimination on grounds of racial and ethnic origin with a view to promoting the principle of equal treatment.
CHAPTER III
BODIES FOR THE PROMOTION OF EQUAL TREATMENT
Article 13
1. Member States shall designate a body or bodies for the promotion of equal treatment of all persons without discrimination on the grounds of racial or ethnic origin. These bodies may form part of agencies charged at national level with the defence of human rights or the safeguard of individuals' rights.
2. Member States shall ensure that the competences of these bodies include:
- without prejudice to the right of victims and of associations, organisations or other legal entities referred to in Article 7(2), providing independent assistance to victims of discrimination in pursuing their complaints about discrimination,
- conducting independent surveys concerning discrimination,
- publishing independent reports and making recommendations on any issue relating to such discrimination.
CHAPTER IV
FINAL PROVISIONS
Article 14
Compliance
Member States shall take the necessary measures to ensure that:
(a) any laws, regulations and administrative provisions contrary to the principle of equal treatment are abolished;
(b) any provisions contrary to the principle of equal treatment which are included in individual or collective contracts or agreements, internal rules of undertakings, rules governing profit-making or non-profit-making associations, and rules governing the independent professions and workers' and employers' organisations, are or may be declared, null and void or are amended.
Article 15
Sanctions
Member States shall lay down the rules on sanctions applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are applied. The sanctions, which may comprise the payment of compensation to the victim, must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by 19 July 2003 at the latest and shall notify it without delay of any subsequent amendment affecting them.
Article 16
Implementation
Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive by 19 July 2003 or may entrust management and labour, at their joint request, with the implementation of this Directive as regards provisions falling within the scope of collective agreements. In such cases, Member States shall ensure that by 19 July 2003, management and labour introduce the necessary measures by agreement, Member States being required to take any necessary measures to enable them at any time to be in a position to guarantee the results imposed by this Directive. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 17
Report
1. Member States shall communicate to the Commission by 19 July 2005, and every five years thereafter, all the information necessary for the Commission to draw up a report to the European Parliament and the Council on the application of this Directive.
2. The Commission's report shall take into account, as appropriate, the views of the European Monitoring Centre on Racism and Xenophobia, as well as the viewpoints of the social partners and relevant non-governmental organisations. In accordance with the principle of gender mainstreaming, this report shall, inter alia, provide an assessment of the impact of the measures taken on women and men. In the light of the information received, this report shall include, if necessary, proposals to revise and update this Directive.
Article 18
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 19
Addressees
This Directive is addressed to the Member States.
|
[
"UKSI20031626"
] |
32000L0045
|
2000
|
Commission Directive 2000/45/EC of 6 July 2000 establishing Community methods of analysis for the determination of vitamin A, vitamin E and tryptophan in feedingstuffs (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs(1), as last amended by the Act of Accession of Austria, Finland and Sweden(2), and in particular Article 2 thereof,
Whereas:
(1) Directive 70/373/EEC stipulates that official controls of feedingstuffs for the purpose of checking compliance with the requirements arising under the laws, regulations and administrative provisions governing their quality and composition must be carried out using Community methods of sampling and analysis.
(2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs(3), as last amended by Commission Regulation (EC) No 2439/1999 of 17 November 1999(4) stipulates that the vitamin A and vitamin E content must be indicated on the labelling where these substances are added to premixtures and feedingstuffs.
(3) Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs(5) as last amended by Commission Directive 2000/16/EC(6) and Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes(7), as last amended by Directive 96/25/EC(8), stipulate that amino acids are to be set out on the feedingstuffs labelling.
(4) Community methods of analysis must be established for checking these substances.
(5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs,
Article 1
The Member States shall provide that analyses conducted with a view to official controls of the vitamin A, vitamin E and tryptophan content of feedingstuffs and premixtures are carried out using the method set out in Annex hereto.
Article 2
The Member States shall bring into force, not later than 31 August 2000, the laws, regulations or administrative provisions necessary to comply with the provisions of this Directive. They shall immediately inform the Commission thereof.
They shall apply the measures from 1 September 2000.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20010541"
] |
32000L0048
|
2000
|
Commission Directive 2000/48/EC of 25 July 2000 amending the Annexes to Council Directives 86/362/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals and certain products of plant origin, including fruit and vegetables respectively (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(1), as last amended by Directive 2000/42/EC(2), and in particular Article 10 thereof,
Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin including fruit and vegetables(3), as last amended by Directive 2000/42/EC, and in particular Article 7 thereof,
Having regard to Council Directive 91/414/EEC of 15 July 1991 on the placing of plant protection products on the market(4), as last amended by Commission Directive 2000/10/EC(5), and in particular Article 4(1)(f) thereof,
Whereas:
(1) The new active substance, azoxystrobin, was included in Annex I to Directive 91/414/EEC by Commission Directive 98/47/EC(6) for use as fungicide only, without specifying particular conditions having an impact on crops which may be treated with plant protection products containing azoxystrobin.
(2) Maximum levels for azoxystrobin residues in and on all commodities covered by Directives 86/362/EEC and 90/642/EEC were fixed by Commission Directive 1999/71/EC(7).
(3) In fixing the said maximum levels for azoxystrobin residues, it was recognised that these levels should be kept under review and should be changed to take account of new information and data. Directive 1999/71/EC acknowledged that national provisional maximum residue levels for other cereals and fruit and vegetables should be fixed by Member States as a part of their authorisation of plant protection products containing azoxystrobin and should be notified to the Commission under the requirements of Article 4(1)(f) to Directive 91/414/EEC. To facilitate this eventuality, some of the levels set in Directive 1999/71/EC were fixed on a provisional basis, enabling Member States to grant further authorisations for new uses and to notify the Commission under the procedure described by the said Article. This Article provides that where a provisional Community maximum residue level exists and where the new authorised use would lead to higher levels, the authorising Member State shall establish a national provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC before the authorisation may be granted.
(4) To ensure that the consumer is adequately protected from exposure to residues in or on products for which no authorisations have been granted, it was considered prudent, in adopting Directive 1999/71/EC, to set provisional maximum residue levels at the lower level of analytical determination for such products. The setting at Community level of such provisional maximum residue levels is without prejudice to the granting of provisional authorisations by the Member States for the use of azoxystrobin on such products in accordance with Article 4(1)(f) of Directive 91/414/EEC.
(5) In order to authorise a plant protection product, Member States must apply the uniform principles provided for in Annex VI to Directive 91/414/EEC in evaluating, in particular, a dossier conforming to the requirements of Annex III to Directive 91/414/EEC, submitted by the applicant for authorisation. Annex III, Part A, Section 8 of Directive 91/414/EEC requires applicants to submit certain information including proposed maximum residue levels together with full justification and estimations of the potential and actual exposure through diet and other means. Annex VI, Part B, Section 2.4.2 and Part C, Section 2.5 of Directive 91/414/EEC provides for Member States to evaluate the information submitted concerning impact on human or animal health arising from residues and the impact on the environment and to take decisions on authorisations which ensure that residues occurring reflect the minimum quantities of the plant protection product necessary to achieve adequate control corresponding to good agricultural practice, applied in such a manner that the residues at harvest, slaughter or after storage, as appropriate, are reduced to a minimum.
(6) New data has been provided for uses of azoxystrobin on rice, bananas, tomatoes and cucurbits with edible and inedible peel. This new data has been evaluated and it is considered appropriate to revise the provisional maximum residue levels fixed for these products in Directive 1999/71/EC.
(7) At the inclusion in Annex I to Directive 91/414/EEC the technical and scientific evaluation of azoxystrobin was finalised on 22 April 1998 in the format of the Commission review report for azoxystrobin. In this review report the acceptable daily intake (ADI) for azoxystrobin was set at 0,1 mg/kg bw/day. The lifetime exposure of consumers of food products treated with azoxystrobin has been assessed and evaluated in accordance with the procedures and practices used within the European Community, taking account of guidelines published by the World Health Organisation(8) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceedence of this ADI.
(8) Acute toxic effects requiring the setting of an acute reference dose were not noted during the evaluation and discussion that preceded the inclusion of azoxystrobin in Annex I to Directive 91/414/EEC.
(9) The Community's trading partners have been consulted about the levels set out in this Directive through the World Trade Organisation and their comments on these levels have been considered. The possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the Commission on the basis of the submission of acceptable data.
(10) The advice and recommendations of the Scientific Committee for Plants, in particular concerning the protection of consumers of food products treated with pesticides, have been taken into account.
(11) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,
Article 1
The following shall be added to part A of Annex II to Directive 86/362/EEC:
">TABLE>"
Article 2
The maximum residues levels in the Annex to this Directive shall replace those listed for azoxystrobin in Annex II to Directive 90/642/EEC.
Article 3
1. This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Communities.
2. Member States shall adopt and publish the legislative, regulatory or administrative measures to comply with this Directive by 31 March 2001 at the latest. They shall forthwith inform the Commission thereof.
3. They shall apply these measures as from 1 April 2001.
4. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20011113"
] |
32000L0056
|
2000
|
Commission Directive 2000/56/EC of 14 September 2000 amending Council Directive 91/439/EEC on driving licences (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 91/439/EEC of 29 July 1991 on driving licences(1), as last amended by Directive 97/26/EC(2), and in particular Article 7(a)(2) thereof,
Whereas:
(1) The list of harmonised Community codes as described in Annex I and Ia to Directive 91/439/EEC needs to be adapted.
(2) The list of harmonised Community codes requires further specification in view of scientific and technical progress in the field and additional practical experience gained with relevant adaptations.
(3) The minimum requirements for driving tests as laid down in Annex II of Directive 91/439/EEC have to be reviewed in the light of scientific and technical progress in the field.
(4) The review of Annex II is necessary in order to further harmonise the driving tests in the Community and to bring the testing requirements into line with the demands of daily traffic. Assessment criteria for the practical test should be introduced to enhance harmonisation further.
(5) The review of Annex II directly aims at improving road safety. Accordingly, the minimum requirements of the theory test and the practical test should be raised.
(6) The measures provided for in this Directive are in conformity with the opinion of the Committee on driving licences,
Article 1
Directive 91/439/EEC is amended as follows:
1. Annex I and Annex Ia are amended as set out in Annex I to this Directive.
2. Annex II is replaced by the text in Annex II to this Directive.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 2003 at the latest. They shall forthwith inform the Commission thereof.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the texts of the essential provisions of national law which they adopt in the field governed by this Directive.
Article 3
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20032003"
] |
32000L0054
|
2000
|
Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC)
Having regard to the Treaty establishing the European Community, and in particular Article 137(2) thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the Economic and Social Committee(1),
After consulting the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),
Whereas:
(1) Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(3) has been substantially amended on a number of occasions(4). For the sake of clarity and rationality Directive 90/679/EEC should be codified.
(2) Compliance with the minimum requirements designed to guarantee a better standard of safety and health as regards the protection of workers from the risks related to exposure to biological agents at work is essential to ensure the safety and health of workers.
(3) This Directive is an individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(5). The provisions of that Directive are therefore fully applicable to the exposure of workers to biological agents, without prejudice to more stringent and/or specific provisions contained in this Directive.
(4) More precise knowledge of the risks involved in exposure to biological agents can be obtained through the keeping of records.
(5) The list and classification of the biological agents must be examined regularly and revised on the basis of new scientific data.
(6) For a number of biological agents details additional to their classification should be given.
(7) Employers must keep abreast of new developments in technology with a view to improving the protection of workers' health and safety.
(8) Preventive measures should be taken for the protection of the health and safety of workers exposed to biological agent.
(9) This Directive constitutes a practical aspect of the realisation of the social dimension of the internal market.
(10) Pursuant to Council Decision 74/325/EEC(6) the Advisory Committee on Safety, Hygiene and Health Protection at Work should be consulted by the Commission with a view to the formulation of proposals in this field. It was so consulted over the formulation of proposals for the Council directives embodied in this Directive.
(11) This Directive is without prejudice to the obligations of the Member States concerning the deadlines for transposition as set out in Annex VIII, Part B,
CHAPTER I
GENERAL PROVISIONS
Article 1
Objective
1. This Directive has as its aim the protection of workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to biological agents at work.
It lays down particular minimum provisions in this area.
2. Directive 89/391/EEC shall apply fully to the whole area referred to in paragraph 1, without prejudice to more stringent and/or specific provisions contained in this Directive.
3. This Directive shall apply without prejudice to the provisions of Council Directive 90/219/EEC(7) and of Council Directive 90/220/EEC(8).
Article 2
Definitions
For the purpose of this Directive:
(a) "biological agents" shall mean micro-organisms, including those which have been genetically modified, cell cultures and human endoparasites, which may be able to provoke any infection, allergy or toxicity;
(b) "micro-organism" shall mean a microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material;
(c) "cell culture" shall mean the in-vitro growth of cells derived from multicellular organisms.
"Biological agents" shall be classified into four risk groups, according to their level of risk of infection:
1. group 1 biological agent means one that is unlikely to cause human disease:
2. group 2 biological agent means one that can cause human disease and might be a hazard to workers; it is unlikely to spread to the community; there is usually effective prophylaxis or treatment available;
3. group 3 biological agent means one that can cause severe human disease and present a serious hazard to workers; it may present a risk of spreading to the community, but there is usually effective prophylaxis or treatment available;
4. group 4 biological agent means one that causes severe human disease and is a serious hazard to workers; it may present a high risk of spreading to the community; there is usually no effective prophylaxis or treatment available.
Article 3
Scope - Determination and assessment of risks
1. This Directive shall apply to activities in which workers are or are potentially exposed to biological agents as a result of their work.
2. In the case of any activity likely to involve a risk of exposure to biological agents, the nature, degree and duration of workers' exposure must be determined in order to make it possible to assess any risk to the workers' health or safety and to lay down the measures to be taken.
In the case of activities involving exposure to several groups of biological agents, the risk shall be assessed on the basis of the danger presented by all hazardous biological agents present.
The assessment must be renewed regularly and in any event when any change occurs in the conditions which may affect workers' exposure to biological agents.
The employer must supply the competent authorities, at their request, with the information used for making the assessment.
3. The assessment referred to in paragraph 2 shall be conducted on the basis of all available information including:
(a) classification of biological agents which are or may be a hazard to human health, as referred to in Article 18;
(b) recommendations from a competent authority which indicate that the biological agent should be controlled in order to protect workers' health when workers are or may be exposed to such a biological agent as a result of their work;
(c) information on diseases which may be contracted as a result of the work of the workers;
(d) potential allergenic or toxigenic effects as a result of the work of the workers;
(e) knowledge of a disease from which a worker is found to be suffering and which has a direct connection with his work.
Article 4
Application of the various Articles in relation to assessment of risks
1. If the results of the assessment referred to in Article 3 show that the exposure and/or potential exposure is to a group 1 biological agent, with no identifiable health risk to workers, Articles 5 to 17 and Article 19 shall not apply.
However, point 1 of Annex VI should be observed.
2. If the results of the assessment referred to in Article 3 show that the activity does not involve a deliberate intention to work with or use a biological agent but may result in the workers' being exposed to a biological agent, as in the course of the activities for which an indicative list is given in Annex I, Articles 5, 7, 8, 10, 11, 12, 13 and 14 shall apply unless the results of the assessment referred to in Article 3 show them to be unnecessary.
CHAPTER II
EMPLOYERS' OBLIGATIONS
Article 5
Replacement
The employer shall avoid the use of a harmful biological agent if the nature of the activity so permits, by replacing it with a biological agent which, under its conditions of use, is not dangerous or is less dangerous to workers' health, as the case may be, in the present state of knowledge.
Article 6
Reduction of risks
1. Where the results of the assessment referred to in Article 3 reveal a risk to workers' health or safety, workers' exposure must be prevented.
2. Where this is not technically practicable, having regard to the activity and the risk assessment referred to in Article 3, the risk of exposure must be reduced to as low a level as necessary in order to protect adequately the health and safety of the workers concerned, in particular by the following measures which are to be applied in the light of the results of the assessment referred to in Article 3:
(a) keeping as low as possible the number of workers exposed or likely to be exposed;
(b) design of work processes and engineering control measures so as to avoid or minimise the release of biological agents into the place of work;
(c) collective protection measures and/or, where exposure cannot be avoided by other means, individual protection measures;
(d) hygiene measures compatible with the aim of the prevention or reduction of the accidental transfer or release of a biological agent from the workplace;
(e) use of the biohazard sign depicted in Annex II and other relevant warning signs;
(f) drawing up plans to deal with accidents involving biological agents;
(g) testing, where it is necessary and technically possible, for the presence, outside the primary physical confinement, of biological agents used at work;
(h) means for safe collection, storage and disposal of waste by workers including the use of secure and identifiable containers, after suitable treatment where appropriate;
(i) arrangements for the safe handling and transport of biological agents within the workplace.
Article 7
Information for the competent authority
1. Where the results of the assessment referred to in Article 3 reveal risk to workers' health or safety, employers shall, when requested, make available to the competent authority appropriate information on:
(a) the results of the assessment;
(b) the activities in which workers have been exposed or may have been exposed to biological agents;
(c) the number of workers exposed;
(d) the name and capabilities of the person responsible for safety and health at work;
(e) the protective and preventive measures taken, including working procedures and methods;
(f) an emergency plan for the protection of workers from exposure to group 3 or a group 4 biological agent which might result from a loss of physical containment.
2. Employers shall inform forthwith the competent authority of any accident or incident which may have resulted in the release of a biological agent and which could cause severe human infection and/or illness.
3. The list referred to in Article 11 and the medical record referred to in Article 14 shall be made available to the competent authority in cases where the undertaking ceases activity, in accordance with national laws and/or practice.
Article 8
Hygiene and individual protection
1. Employers shall be obliged, in the case of all activities for which there is a risk to the health or safety of workers due to work with biological agents, to take appropriate measures to ensure that:
(a) workers do not eat or drink in working areas where there is a risk of contamination by biological agents;
(b) workers are provided with appropriate protective clothing or other appropriate special clothing;
(c) workers are provided with appropriate and adequate washing and toilet facilities, which may include eye washes and/or skin antiseptics;
(d) any necessary protective equipment is:
- properly stored in a well-defined place,
- checked and cleaned if possible before, and in any case after, each use,
- is repaired, where defective, or is replaced before further use;
(e) procedures are specified for taking, handling and processing samples of human or animal origin.
2. Working clothes and protective equipment, including protective clothing referred to in paragraph 1, which may be contaminated by biological agents, must be removed on leaving the working area and, before taking the measures referred to in the second subparagraph, kept separately from other clothing.
The employer must ensure that such clothing and protective equipment is decontaminated and cleaned or, if necessary, destroyed.
3. Workers may not be charged for the cost of the measures referred to in paragraphs 1 and 2.
Article 9
Information and training of workers
1. Appropriate measures shall be taken by the employer to ensure that workers and/or any workers' representatives in the undertaking or establishment receive sufficient and appropriate training, on the basis of all available information, in particular in the form of information and instructions, concerning:
(a) potential risks to health;
(b) precautions to be taken to prevent exposure;
(c) hygiene requirements;
(d) wearing and use of protective equipment and clothing;
(e) steps to be taken by workers in the case of incidents and to prevent incidents.
2. The training shall be:
(a) given at the beginning of work involving contact with biological agents,
(b) adapted to take account of new or changed risks, and
(c) repeated periodically if necessary.
Article 10
Worker information in particular cases
1. Employers shall provide written instructions at the workplace and, if appropriate, display notices which shall, as a minimum, include the procedure to be followed in the case of:
(a) a serious accident or incident involving the handling of a biological agent;
(b) handling a group 4 biological agent.
2. Workers shall immediately report any accident or incident involving the handling of a biological agent to the person in charge, or to the person responsible for safety and health at work.
3. Employers shall inform forthwith the workers and/or any workers' representatives of any accident or incident which may have resulted in the release of a biological agent and which could cause severe human infection and/or illness.
In addition, employers shall inform the workers and/or any workers' representatives in the undertaking or establishment as quickly as possible when a serious accident or incident occurs, of the causes thereof and of the measures taken or to be taken to rectify the situation.
4. Each worker shall have access to the information on the list referred to in Article 11 which relates to him personally.
5. Workers and/or any workers' representatives in the undertaking or establishment shall have access to anonymous collective information.
6. Employers shall provide workers and/or their representatives, at their requst, with the information provided for in Article 7(1).
Article 11
List of exposed workers
1. Employers shall keep a list of workers exposed to group 3 and/or group 4 biological agents, indicating the type of work done and, whenever possible, the biological agent to which they have been exposed, as well as records of exposures, accidents and incidents, as appropriate.
2. The list referred to in paragraph 1 shall be kept for at least 10 years following the end of exposure, in accordance with national laws and/or practice.
In the case of those exposures which may result in infections:
(a) with biological agents known to be capable of establishing persistent or latent infections;
(b) that, in the light of present knowledge, are undiagnosable until illness develops many years later;
(c) that have particularly long incubation periods before illness develops;
(d) that result in illnesses which recrudesce at times over a long period despite treatment, or
(e) that may have serious long-term sequelae,
the list shall be kept for an appropriately longer time up to 40 years following the last known exposure.
3. The doctor referred to in Article 14 and/or the competent authority for health and safety at work, and any other person responsible for health and safety at work, shall have access to the list referred to in paragraph 1.
Article 12
Consultation and participation of workers
Consultation and participation of workers and/or their representatives in connection with matters covered by this Directive shall take place in accordance with Article 11 of Directive 89/391/EEC.
Article 13
Notification to the competent authority
1. Prior notification shall be made to the competent authority of the use for the first time of:
(a) group 2 biological agents;
(b) group 3 biological agents;
(c) group 4 biological agents.
The notification shall be made at least 30 days before the commencement of the work.
Subject to paragraph 2, prior notification shall also be made of the use for the first time of each subsequent group 4 biological agent and of any subsequent new group 3 biological agent where the employer himself provisionally classifies that biological agent.
2. Laboratories providing a diagnostic service in relation to group 4 biological agents shall be required only to make an initial notification of their intention.
3. Renotification must take place in any case where there are substantial changes of importance to safety or health at work to processes and/or procedures which render the notification out of date.
4. The notification referred to in paragraphs 1, 2 and 3 shall include:
(a) the name and address of the undertaking and/or establishment;
(b) the name and capabilities of the person responsible for safety and health at work;
(c) the results of the assessment referred to in Article 3;
(d) the species of the biological agent;
(e) the protection and preventive measures that are envisaged.
CHAPTER III
MISCELLANEOUS PROVISIONS
Article 14
Health surveillance
1. The Member States shall establish, in accordance with national laws and practice, arrangements for carrying out relevant health surveillance of workers for whom the results of the assessment referred to in Article 3 reveal a risk to health or safety.
2. The arrangements referred to in paragraph 1 shall be such that each worker shall be able to undergo, if appropriate, relevant health surveillance:
(a) prior to exposure;
(b) at regular intervals thereafter.
Those arrangements shall be such that it is directly possible to implement individual and occupational hygiene measures.
3. The assessment referred to in Article 3 should identify those workers for whom special protective measures may be required.
When necessary, effective vaccines should be made available for those workers who are not already immune to the biological agent to which they are exposed or are likely to be exposed.
When employers make vaccines available, they should take account of the recommended code of practice set out in Annex VII.
If a worker is found to be suffering from an infection and/or illness which is suspected to be the result of exposure, the doctor or authority responsible for health surveillance of workers shall offer such surveillance to other workers who have been similarly exposed.
In that event, a reassessment of the risk of exposure shall be carried out in accordance with Article 3.
4. In cases where health surveillance is carried out, an individual medical record shall be kept for at least 10 years following the end of exposure, in accordance with national laws and practice.
In the special cases referred to in Article 11(2) second subparagraph, an individual medical record shall be kept for an appropriately longer time up to 40 years following the last known exposure.
5. The doctor or authority responsible for health surveillance shall propose any protective or preventive measures to be taken in respect of any individual worker.
6. Information and advice must be given to workers regarding any health surveillance which they may undergo following the end of exposure.
7. In accordance with national laws and/or practice:
(a) workers shall have access to the results of the health surveillance which concern them, and
(b) the workers concerned or the employer may request a review of the results of the health surveillance.
8. Practical recommendations for the health surveillance of workers are given in Annex IV.
9. All cases of diseases or death identified in accordance with national laws and/or practice as resulting from occupational exposure to biological agents shall be notified to the competent authority.
Article 15
Health and veterinary care facilities other than diagnostic laboratories
1. For the purpose of the assessment referred to in Article 3, particular attention should be paid to:
(a) uncertainties about the presence of biological agents in human patients or animals and the materials and speciments taken from them;
(b) the hazard represented by biological agents known or suspected to be present in human patients or animals and materials and specimens taken from them;
(c) the risks posed by the nature of the work.
2. Appropriate measures shall be taken in health and veterinary care facilities in order to protect the health and safety of the workers concerned.
The measures to be taken shall include in particular:
(a) specifying appropriate decontamination and disinfection procedures, and
(b) implementing procedures enabling contaminated waste to be handled and disposed of without risk.
3. In isolation facilities where there are human patients or animals who are, or who are suspected of being, infected with group 3 or group 4 biological agents, containment measures shall be selected from those in Annex V column A, in order to minimise the risk of infection.
Article 16
Special measures for industrial processes, laboratories and animal rooms
1. The following measures must be taken in laboratories, including diagnostic laboratories, and in rooms for laboratory animals which have been deliberately infected with group 2, 3 or 4 biological agents or which are or are suspected to be carriers of such agents.
(a) Laboratories carrying out work which involves the handling of group 2, 3 or 4 biological agents for research, development, teaching or diagnostic purposes shall determine the containment measures in accordance with Annex V, in order to minimise the risk of infection.
(b) Following the assessment referred to in Article 3, measures shall be determined in accordance with Annex V, after fixing the physical containment level required for the biological agents according to the degree of risk.
Activities involving the handling of a biological agent must be carried out:
- only in working areas corresponding to at least containment level 2, for a group 2 biological agent,
- only in working areas corresponding to at least containment level 3, for a group 3 biological agent,
- only in working areas corresponding to at least containment level 4, for a group 4 biological agent.
(c) Laboratories handling materials in respect of which there exist uncertainties about the presence of biological agents which may cause human disease but which do not have as their aim working with biological agents as such (i.e. cultivating or concentrating them) should adopt containment level 2 at least. Containment levels 3 or 4 must be used, when appropriate, where it is known or it is suspected that they are necessary, except where guidelines provided by the competent national authorities show that, in certain cases, a lower containment level is appropriate.
2. The following measures concerning industrial processes using group 2, 3 or 4 biological agents must be taken:
(a) The containment principles set out in the second subparagraph of paragraph 1(b) should also apply to industrial processes on the basis of the practical measures and appropriate procedures given in Annex VI.
(b) In accordance with the assessment of the risk linked to the use of group 2, 3 or 4 biological agents, the competent authorities may decide on appropriate measures which must be applied to the industrial use of such biological agents.
3. For all activities covered by paragraphs 1 and 2 where it has not been possible to carry out a conclusive assessment of a biological agent but concerning which it appears that the use envisaged might involve a serious health risk for workers, activities may only be carried out in workplaces where the containment level corresponds at least to level 3.
Article 17
Use of data
The Commission shall have access to the use made by the competent national authorities of the information referred to in Article 14(9).
Article 18
Classification of biological agents
1. Community classification shall be on the basis of the definitions in the second paragraph of Article 2, points 2 to 4 (groups 2 to 4).
2. Pending Community classification Member States shall classify biologial agents that are or may be a hazard to human health on the basis of the definition in the second paragraph of Article 2, points 2 to 4 (groups 2 to 4).
3. If the biological agent tobe assessed cannot be classified clearly in one of the groups defined in the second paragraph of Article 2, it must be classified in the highest risk group among the alternatives.
Article 19
Annexes
Purely technical adjustments to the Annexes in the light of technical progress, changes in international regulations or specifications and new findings in the field of biological agents shall be adopted in accordance with the procedure laid down in Article 17 of Directive 89/391/EEC.
Article 20
Notifying the Commission
Member States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive.
Article 21
Repeal
Directive 90/679/EEC, amended by the Directives referred to in Annex VIII, part A is repealed, without prejudice to the obligations of the Member States in respect of the deadlines for transposition laid down in Annex VIII, part B.
References to the repealed Directive shall be construed as references to this Directive and shall be correlated in accordance with the correlation table set out in Annex IX.
Article 22
Entry into force
This Directive enters into force on the twentieth day following its publication in the Official Journal of the European Communities.
Article 23
Addresses
This Directive is addressed to the Member States.
|
[
"UKSI20100323"
] |
32000L0046
|
2000
|
Directive 2000/46/EC of the European Parliament and of the Council of 18 September 2000 on the taking up, pursuit of and prudential supervision of the business of electronic money institutions
Having regard to the Treaty establishing the European Community, and in particular the first and third sentences of Article 47(2) thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Having regard to the opinion of the European Central Bank(3),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(4),
Whereas:
(1) Credit institutions within the meaning of Article 1, point 1, first subparagraph (b) of Directive 2000/12/EC(5) are limited in the scope of their activities.
(2) It is necessary to take account of the specific characteristics of these institutions and to provide the appropriate measures necessary to coordinate and harmonise Member States' laws, regulations and administrative provisions relating to the taking up, pursuit and prudential supervision of the business of electronic money institutions.
(3) For the purposes of this Directive, electronic money can be considered an electronic surrogate for coins and banknotes, which is stored on an electronic device such as a chip card or computer memory and which is generally intended for the purpose of effecting electronic payments of limited amounts.
(4) The approach adopted is appropriate to achieve only the essential harmonisation necessary and sufficient to secure the mutual recognition of authorisation and prudential supervision of electronic money institutions, making possible the granting of a single licence recognised throughout the Community and designed to ensure bearer confidence and the application of the principle of home Member State prudential supervision.
(5) Within the wider context of the rapidly evolving electronic commerce it is desirable to provide a regulatory framework that assists electronic money in delivering its full potential benefits and that avoids hampering technological innovation in particular. Therefore, this Directive introduces a technology-neutral legal framework that harmonises the prudential supervision of electronic money institutions to the extent necessary for ensuring their sound and prudent operation and their financial integrity in particular.
(6) Credit institutions, by virtue of point 5 of Annex I to Directive 2000/12/EC, are already allowed to issue and administer means of payment including electronic money and to carry on such activities Community-wide subject to mutual recognition and to the comprehensive prudential supervisory system applying to them in accordance with the European banking Directives.
(7) The introduction of a separate prudential supervisory regime for electronic money institutions, which, although calibrated on the prudential supervisory regime applying to other credit institutions and Directive 2000/12/EC except Title V, Chapters 2 and 3 thereof in particular, differs from that regime, is justified and desirable because the issuance of electronic money does not constitute in itself, in view of its specific character as an electronic surrogate for coins and banknotes, a deposit-taking activity pursuant to Article 3 of Directive 2000/12/EC, if the received funds are immediately exchanged for electronic money.
(8) The receipt of funds from the public in exchange for electronic money, which results in a credit balance left on account with the issuing institution, constitutes the receipt of deposits or other repayable funds for the purpose of Directive 2000/12/EC.
(9) It is necessary for electronic money to be redeemable to ensure bearer confidence. Redeemability does not imply, in itself, that the funds received in exchange for electronic money shall be regarded as deposits or other repayable funds for the purpose of Directive 2000/12/EC.
(10) Redeemability should always be understood to be at par value.
(11) In order to respond to the specific risks associated with the issuance of electronic money this prudential supervisory regime must be more targeted and, accordingly, less cumbersome than the prudential supervisory regime applying to credit institutions, notably as regards reduced initial capital requirements and the non-application of Directive 93/6/EEC(6) and Title V, Chapter 2, Sections II and III of Directive 2000/12/EC.
(12) However, it is necessary to preserve a level playing field between electronic money institutions and other credit institutions issuing electronic money and, thus, to ensure fair competition among a wider range of institutions to the benefit of bearers. This is achieved since the abovementioned less cumbersome features of the prudential supervisory regime applying to electronic money institutions are balanced by provisions that are more stringent than those applying to other credit institutions, notably as regards restrictions on the business activities which electronic money institutions may carry on and, particularly, prudent limitations of their investments aimed at ensuring that their financial liabilities related to outstanding electronic money are backed at all times by sufficiently liquid low risk assets.
(13) Pending the harmonisation of prudential supervision of outsourced activities for credit institutions it is appropriate that electronic money institutions have sound and prudent management and control procedures. With a view to the possibility of operational and other ancilliary functions related to the issuance of electronic money being performed by undertakings which are not subject to prudential supervision it is essential that electronic money institutions have in place internal structures which should respond to the financial and non-financial risks to which they are exposed.
(14) The issuance of electronic money may affect the stability of the financial system and the smooth operation of payments systems. Close cooperation in assessing the integrity of electronic money schemes is called for.
(15) It is appropriate to afford competent authorities the possibility of waiving some or all of the requirements imposed by this Directive for electronic money institutions which operate only within the territories of the respective Member States.
(16) Adoption of this Directive constitutes the most appropriate means of achieving the desired objectives. This Directive is limited to the minimum necessary to achieve these objectives and does not go beyond what is necessary for this purpose.
(17) Provision should be made for the review of this Directive in the light of experience of developments in the market and the protection of bearers of electronic money.
(18) The Banking Advisory Committee has been consulted on the adoption of this Directive,
Article 1
Scope, definitions and restriction of activities
1. This Directive shall apply to electronic money institutions.
2. It shall not apply to the institutions referred to in Article 2(3) of Directive 2000/12/EC.
3. For the purposes of this Directive:
(a) "electronic money institution" shall mean an undertaking or any other legal person, other than a credit institution as defined in Article 1, point 1, first subparagraph (a) of Directive 2000/12/EC which issues means of payment in the form of electronic money;
(b) "electronic money" shall mean monetary value as represented by a claim on the issuer which is:
(i) stored on an electronic device;
(ii) issued on receipt of funds of an amount not less in value than the monetary value issued;
(iii) accepted as means of payment by undertakings other than the issuer.
4. Member States shall prohibit persons or undertakings that are not credit institutions, as defined in Article 1, point 1, first subparagraph of Directive 2000/12/EC, from carrying on the business of issuing electronic money.
5. The business activities of electronic money institutions other than the issuing of electronic money shall be restricted to:
(a) the provision of closely related financial and non-financial services such as the administering of electronic money by the performance of operational and other ancillary functions related to its issuance, and the issuing and administering of other means of payment but excluding the granting of any form of credit; and
(b) the storing of data on the electronic device on behalf of other undertakings or public institutions.
Electronic money institutions shall not have any holdings in other undertakings except where these undertakings perform operational or other ancillary functions related to electronic money issued or distributed by the institution concerned.
Article 2
Application of Banking Directives
1. Save where otherwise expressly provided for, only references to credit institutions in Directive 91/308/EEC(7) and Directive 2000/12/EC except Title V, Chapter 2 thereof shall apply to electronic money institutions.
2. Articles 5, 11, 13, 19, 20(7), 51 and 59 of Directive 2000/12/EC shall not apply. The mutual recognition arrangements provided for in Directive 2000/12/EC shall not apply to electronic money institutions' business activities other than the issuance of electronic money.
3. The receipt of funds within the meaning of Article 1(3)(b)(ii) does not constitute a deposit or other repayable funds according to Article 3 of Directive 2000/12/EC, if the funds received are immediately exchanged for electronic money.
Article 3
Redeemability
1. A bearer of electronic money may, during the period of validity, ask the issuer to redeem it at par value in coins and bank notes or by a transfer to an account free of charges other than those strictly necessary to carry out that operation.
2. The contract between the issuer and the bearer shall clearly state the conditions of redemption.
3. The contract may stipulate a minimum threshold for redemption. The threshold may not exceed EUR 10.
Article 4
Initial capital and ongoing own funds requirements
1. Electronic money institutions shall have an initial capital, as defined in Article 34(2), subparagraphs (1) and (2) of Directive 2000/12/EC, of not less than EUR 1 million. Notwithstanding paragraphs 2 and 3, their own funds, as defined in Directive 2000/12/EC, shall not fall below that amount.
2. Electronic money institutions shall have at all times own funds which are equal to or above 2 % of the higher of the current amount or the average of the preceding six months' total amount of their financial liabilities related to outstanding electronic money.
3. Where an electronic money institution has not completed a six months' period of business, including the day it starts up, it shall have own funds which are equal to or above 2 % of the higher of the current amount or the six months' target total amount of its financial liabilities related to outstanding electronic money. The six months' target total amount of the institution's financial liabilities related to outstanding electronic money shall be evidenced by its business plan subject to any adjustment to that plan having been required by the competent authorities.
Article 5
Limitations of investments
1. Electronic money institutions shall have investments of an amount of no less than their financial liabilities related to outstanding electronic money in the following assets only:
(a) asset items which according to Article 43(1)(a) (1), (2), (3) and (4) and Article 44(1) of Directive 2000/12/EC attract a zero credit risk weighting and which are sufficiently liquid;
(b) sight deposits held with Zone A credit institutions as defined in Directive 2000/12/EC; and
(c) debt instruments which are:
(i) sufficiently liquid;
(ii) not covered by paragraph 1(a);
(iii) recognised by competent authorities as qualifying items within the meaning of Article 2(12) of Directive 93/6/EEC; and
(iv) issued by undertakings other than undertakings which have a qualifying holding, as defined in Article 1 of Directive 2000/12/EC, in the electronic money institution concerned or which must be included in those undertakings' consolidated accounts.
2. Investments referred to in paragraph 1(b) and (c) may not exceed 20 times the own funds of the electronic money institution concerned and shall be subject to limitations which are at least as stringent as those applying to credit institutions in accordance with Title V, Chapter 2, Section III of Directive 2000/12/EC.
3. For the purpose of hedging market risks arising from the issuance of electronic money and from the investments referred to in paragraph 1, electronic money institutions may use sufficiently liquid interest-rate and foreign-exchange-related off balance-sheet items in the form of exchange-traded (i.e. not OTC) derivative instruments where they are subject to daily margin requirements or foreign exchange contracts with an original maturity of 14 calendar days or less. The use of derivative instruments according to the first sentence is permissible only if the full elimination of market risks is intended and, to the extent possible, achieved.
4. Member States shall impose appropriate limitations on the market risks electronic money institutions may incur from the investments referred to in paragraph 1.
5. For the purpose of applying paragraph 1, assets shall be valued at the lower of cost or market value.
6. If the value of the assets referred to in paragraph 1 falls below the amount of financial liabilities related to outstanding electronic money, the competent authorities shall ensure that the electronic money institution in question takes appropriate measures to remedy that situation promptly. To this end, and for a temporary period only, the competent authorities may allow the institution's financial liabilities related to outstanding electronic money to be backed by assets other than those referred to in paragraph 1 up to an amount not exceeding the lower of 5 % of these liabilities or the institution's total amount of own funds.
Article 6
Verification of specific requirements by the competent authorities
The competent authorities shall ensure that the calculations justifying compliance with Articles 4 and 5 are made, not less than twice each year, either by electronic money institutions themselves, which shall communicate them, and any component data required, to the competent authorities, or by competent authorities, using data supplied by the electronic money institutions.
Article 7
Sound and prudent operation
Electronic money institutions shall have sound and prudent management, administrative and accounting procedures and adequate internal control mechanisms. These should respond to the financial and non-financial risks to which the institution is exposed including technical and procedural risks as well as risks connected to its cooperation with any undertaking performing operational or other ancillary functions related to its business activities.
Article 8
Waiver
1. Member States may allow their competent authorities to waive the application of some or all of the provisions of this Directive and the application of Directive 2000/12/EC to electronic money institutions in cases where either:
(a) the total business activities of the type referred to in Article 1(3)(a) of this Directive of the institution generate a total amount of financial liabilities related to outstanding electronic money that normally does not exceed EUR 5 million and never exceeds EUR 6 million; or
(b) the electronic money issued by the institution is accepted as a means of payment only by any subsidiaries of the institution which perform operational or other ancillary functions related to electronic money issued or distributed by the institution, any parent undertaking of the institution or any other subsidiaries of that parent undertaking; or
(c) electronic money issued by the institution is accepted as payment only by a limited number of undertakings, which can be clearly distinguished by:
(i) their location in the same premises or other limited local area; or
(ii) their close financial or business relationship with the issuing institution, such as a common marketing or distribution scheme.
The underlying contractual arrangements must provide that the electronic storage device at the disposal of bearers for the purpose of making payments is subject to a maximum storage amount of not more than EUR 150.
2. An electronic money institution for which a waiver has been granted under paragraph 1 shall not benefit from the mutual recognition arrangements provided for in Directive 2000/12/EC.
3. Member States shall require that all electronic money institutions to which the application of this Directive and Directive 2000/12/EC has been waived report periodically on their activities including the total amount of financial liabilities related to electronic money.
Article 9
Grandfathering
Electronic money institutions subject to this Directive which have commenced their activity in accordance with the provisions in force in the Member State in which they have their head office before the date of entry into force of the provisions adopted in implementation of this Directive or the date referred to in Article 10(1), whichever date is earlier, shall be presumed to be authorised. The Member States shall oblige such electronic money institutions to submit all relevant information to the competent authorities in order to allow them to assess within six months from the date of entry into force of the provisions adopted in implementation of this Directive, whether the institutions comply with the requirements pursuant to this Directive, which measures need to be taken in order to ensure compliance, or whether a withdrawal of authorisation is appropriate. If compliance is not ensured within six months from the date referred to in Article 10(1), the electronic money institution shall not benefit from mutual recognition after that time.
Article 10
Implementation
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 27 April 2002. They shall immediately inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the text of the main provisions of national law, which they adopt in the field covered by this Directive.
Article 11
Review
Not later than 27 April 2005 the Commission shall present a report to the European Parliament and the Council on the application of this Directive, in particular on:
- the measures to protect the bearers of electronic money, including the possible need to introduce a guarantee scheme,
- capital requirements,
- waivers, and
- the possible need to prohibit interest being paid on funds received in exchange for electronic money,
accompanied where appropriate by a proposal for its revision.
Article 12
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 13
This Directive is addressed to the Member States.
|
[
"UKSI20020682",
"UKSI20020765"
] |
32000L0053
|
2000
|
Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of life vehicles - Commission Statements
Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Having consulted the Committee of the Regions,
Acting in accordance with the procedure referred to in Article 251 of the Treaty in the light of the joint text approved by the Conciliation Committee on 23 May 2000(3),
Whereas
(1) The different national measures concerning end-of life vehicles should be harmonised in order, first, to minimise the impact of end-of life vehicles on the environment, thus contributing to the protection, preservation and improvement of the quality of the environment and energy conservation, and, second, to ensure the smooth operation of the internal market and avoid distortions of competition in the Community.
(2) A Community-wide framework is necessary in order to ensure coherence between national approaches in attaining the objectives stated above, particularly with a view to the design of vehicles for recycling and recovery, to the requirements for collection and treatment facilities, and to the attainment of the targets for reuse, recycling and recovery, taking into account the principle of subsidiarity and the polluter-pays principle.
(3) Every year end-of life vehicles in the Community generate between 8 and 9 million tonnes of waste, which must be managed correctly.
(4) In order to implement the precautionary and preventive principles and in line with the Community strategy for waste management, the generation of waste must be avoided as much as possible.
(5) It is a further fundamental principle that waste should be reused and recovered, and that preference be given to reuse and recycling.
(6) Member States should take measures to ensure that economic operators set up systems for the collection, treatment and recovery of end-of life vehicles.
(7) Member States should ensure that the last holder and/or owner can deliver the end-of life vehicle to an authorised treatment facility without any cost as a result of the vehicle having no or a negative, market value. Member States should ensure that producers meet all, or a significant part of, the costs of the implementation of these measures; the normal functioning of market forces should not be hindered.
(8) This Directive should cover vehicles and end-of life vehicles, including their components and materials, as well as spare and replacement parts, without prejudice to safety standards, air emissions and noise control.
(9) This Directive should be understood as having borrowed, where appropriate, the terminology used by several existing directives, namely Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(4), Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers(5), and Council Directive 75/442/EEC of 15 July 1975 on waste(6).
(10) Vintage vehicles, meaning historic vehicles or vehicles of value to collectors or intended for museums, kept in a proper and environmentally sound manner, either ready for use or stripped into parts, are not covered by the definition of waste laid down by Directive 75/442/EEC and do not fall within the scope of this Directive.
(11) It is important that preventive measures be applied from the conception phase of the vehicle onwards and take the form, in particular, of reduction and control of hazardous substances in vehicles, in order to prevent their release into the environment, to facilitate recycling and to avoid the disposal of hazardous waste. In particular the use of lead, mercury, cadmium and hexavalent chromium should be prohibited. These heavy metals should only be used in certain applications according to a list which will be regularly reviewed. This will help to ensure that certain materials and components do not become shredder residues, and are not incinerated or disposed of in landfills.
(12) The recycling of all plastics from end-of life vehicles should be continuously improved. The Commission is currently examining the environmental impacts of PVC. The Commission will, on the basis of this work, make proposals as appropriate as to the use of PVC including considerations for vehicles.
(13) The requirements for dismantling, reuse and recycling of end-of life vehicles and their components should be integrated in the design and production of new vehicles.
(14) The development of markets for recycled materials should be encouraged.
(15) In order to ensure that end-of life vehicles are discarded without endangering the environment, appropriate collection systems should be set up.
(16) A certificate of destruction, to be used as a condition for the de-registration of end-of life vehicles, should be introduced. Member States without a de-registration system should set up a system according to which a certificate of destruction is notified to the relevant competent authority when the end-of life vehicle is transferred to a treatment facility.
(17) This Directive does not prevent Member States from granting, where appropriate, temporary deregistrations of vehicles.
(18) Collection and treatment operators should be allowed to operate only when they have received a permit or, in case a registration is used instead of a permit, specific conditions have been complied with.
(19) The recyclability and recoverability of vehicles should be promoted.
(20) It is important to lay down requirements for storage and treatment operations in order to prevent negative impacts on the environment and to avoid the emergence of distortions in trade and competition.
(21) In order to achieve results in the short term and to give operators, consumers and public authorities the necessary perspective for the longer term, quantified targets for reuse, recycling and recovery to be achieved by economic operators should be set.
(22) Producers should ensure that vehicles are designed and manufactured in such a way as to allow the quantified targets for reuse, recycling and recovery to be achieved. To this end the Commission will promote the preparation of European standards and will take the other necessary measures in order to amend the pertinent European vehicle type-approval legislation.
(23) Member States should ensure that in implementing the provisions of this Directive competition is preserved, in particular as regards the access of small and medium-sized enterprises to the collection, dismantling, treatment and recycling market.
(24) In order to facilitate the dismantling and recovery, in particular recycling of end-of life vehicles, vehicle manufacturers should provide authorised treatment facilities with all requisite dismantling information, in particular for hazardous materials.
(25) The preparation of European standards, where appropriate, should be promoted. Vehicle manufacturers and material producers should use component and material coding standards, to be established by the Commission assisted by the relevant committee. In the preparation of these standards the Commission will take account, as appropriate, of the work going on in this area in the relevant international forums.
(26) Community-wide data on end-of life vehicles are needed in order to monitor the implementation of the objectives of this Directive.
(27) Consumers have to be adequately informed in order to adjust their behaviour and attitudes; to this end information should be made available by the relevant economic operators.
(28) Member States may choose to implement certain provisions by means of agreements with the economic sector concerned, provided that certain conditions are met.
(29) The adaptation to scientific and technical progress of the requirements for treatment facilities and for the use of hazardous substances and, as well as the adoption of minimum standards for the certificate of destruction, the formats for the database and the implementation measures necessary to control compliance with the quantified targets should be effected by the Commission under a Committee procedure.
(30) The measures to be taken for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(7).
(31) Member States may apply the provisions of this Directive in advance of the date set out therein, provided such measures are compatible with the Treaty,
Article 1
Objectives
This Directive lays down measures which aim, as a first priority, at the prevention of waste from vehicles and, in addition, at the reuse, recycling and other forms of recovery of end-of life vehicles and their components so as to reduce the disposal of waste, as well as at the improvement in the environmental performance of all of the economic operators involved in the life cycle of vehicles and especially the operators directly involved in the treatment of end-of life vehicles.
Article 2
Definitions
For the purposes of this Directive:
1. "vehicle" means any vehicle designated as category M1 or N1 defined in Annex IIA to Directive 70/156/EEC, and three wheel motor vehicles as defined in Directive 92/61/EEC, but excluding motor tricycles;
2. "end-of life vehicle" means a vehicle which is waste within the meaning of Article 1(a) of Directive 75/442/EEC;
3. "producer" means the vehicle manufacturer or the professional importer of a vehicle into a Member State;
4. "prevention" means measures aiming at the reduction of the quantity and the harmfulness for the environment of end-of life vehicles, their materials and substances;
5. "treatment" means any activity after the end-of life vehicle has been handed over to a facility for depollution, dismantling, shearing, shredding, recovery or preparation for disposal of the shredder wastes, and any other operation carried out for the recovery and/or disposal of the end-of life vehicle and its components;
6. "reuse" means any operation by which components of end-of life vehicles are used for the same purpose for which they were conceived;
7. "recycling" means the reprocessing in a production process of the waste materials for the original purpose or for other purposes but excluding energy recovery. Energy recovery means the use of combustible waste as a means to generate energy through direct incineration with or without other waste but with recovery of the heat;
8. "recovery" means any of the applicable operations provided for in Annex IIB to Directive 75/442/EEC;
9. "disposal" means any of the applicable operations provided for in Annex IIA to Directive 75/442/EEC;
10. "economic operators" means producers, distributors, collectors, motor vehicle insurance companies, dismantlers, shredders, recoverers, recyclers and other treatment operators of end-of life vehicles, including their components and materials;
11. "hazardous substance" means any substance which is considered to be dangerous under Directive 67/548/EEC;
12. "shredder" means any device used for tearing into pieces or fragmenting end-of life vehicles, including for the purpose of obtaining directly reusable metal scrap;
13. "dismantling information" means all information required for the correct and environmentally sound treatment of end-of life vehicles. It shall be made available to authorised treatment facilities by vehicle manufacturers and component producers in the form of manuals or by means of electronic media (e.g. CD-ROM, on-line services).
Article 3
Scope
1. This Directive shall cover vehicles and end-of life vehicles, including their components and materials. Without prejudice to Article 5(4), third subparagraph, this shall apply irrespective of how the vehicle has been serviced or repaired during use and irrespective of whether it is equipped with components supplied by the producer or with other components whose fitting as spare or replacement parts accords with the appropriate Community provisions or domestic provisions.
2. This Directive shall apply without prejudice to existing Community legislation and relevant national legislation, in particular as regards safety standards, air emissions and noise controls and the protection of soil and water.
3. Where a producer only makes or imports vehicles that are exempt from Directive 70/156/EEC by virtue of Article 8(2)(a) thereof, Member States may exempt that producer and his vehicles from Articles 7(4), 8 and 9 of this Directive.
4. Special-purpose vehicles as defined in the second indent of Article 4(1)(a) of Directive 70/156/EEC shall be excluded from the provisions of Article 7 of this Directive.
5. For three-wheel motor vehicles only Articles 5(1), 5(2) and 6 of this Directive shall apply.
Article 4
Prevention
1. In order to promote the prevention of waste Member States shall encourage, in particular:
(a) vehicle manufacturers, in liaison with material and equipment manufacturers, to limit the use of hazardous substances in vehicles and to reduce them as far as possible from the conception of the vehicle onwards, so as in particular to prevent their release into the environment, make recycling easier, and avoid the need to dispose of hazardous waste;
(b) the design and production of new vehicles which take into full account and facilitate the dismantling, reuse and recovery, in particular the recycling, of end-of life vehicles, their components and materials;
(c) vehicle manufacturers, in liaison with material and equipment manufacturers, to integrate an increasing quantity of recycled material in vehicles and other products, in order to develop the markets for recycled materials.
2. (a) Member States shall ensure that materials and components of vehicles put on the market after 1 July 2003 do not contain lead, mercury, cadmium or hexavalent chromium other than in cases listed in Annex II under the conditions specified therein;
(b) in accordance with the procedure laid down in Article 11 the Commission shall on a regular basis, according to technical and scientific progress, amend Annex II, in order to:
(i) as necessary, establish maximum concentration values up to which the existence of the substances referred to in subparagraph (a) in specific materials and components of vehicles shall be tolerated;
(ii) exempt certain materials and components of vehicles from the provisions of subparagraph (a) if the use of these substances is unavoidable;
(iii) delete materials and components of vehicles from Annex II if the use of these substances is avoidable;
(iv) under points (i) and (ii) designate those materials and components of vehicles that can be stripped before further treatment; they shall be labelled or made identifiable by other appropriate means;
(c) the Commission shall amend Annex II for the first time not later than 21 October 2001. In any case none of the exemptions listed therein shall be deleted from the Annex before 1 January 2003.
Article 5
Collection
1. Member States shall take the necessary measures to ensure:
- that economic operators set up systems for the collection of all end-of life vehicles and, as far as technically feasible, of waste used parts removed when passenger cars are repaired,
- the adequate availability of collection facilities within their territory.
2. Member States shall also take the necessary measures to ensure that all end-of life vehicles are transferred to authorised treatment facilities.
3. Member States shall set up a system according to which the presentation of a certificate of destruction is a condition for deregistration of the end-of life vehicle. This certificate shall be issued to the holder and/or owner when the end-of life vehicle is transferred to a treatment facility. Treatment facilities, which have obtained a permit in accordance with Article 6, shall be permitted to issue a certificate of destruction. Member States may permit producers, dealers and collectors on behalf of an authorised treatment facility to issue certificates of destruction provided that they guarantee that the end-of life vehicle is transferred to an authorised treatment facility and provided that they are registered with public authorities.
Issuing the certificate of destruction by treatment facilities or dealers or collectors on behalf of an authorised treatment facility does not entitle them to claim any financial reimbursement, except in cases where this has been explicitly arranged by Member States.
Member States which do not have a deregistration system at the date of entry into force of this Directive shall set up a system according to which a certificate of destruction is notified to the relevant competent authority when the end-of life vehicle is transferred to a treatment facility and shall otherwise comply with the terms of this paragraph. Member States making use of this subparagraph shall inform the Commission of the reasons thereof.
4. Member States shall take the necessary measures to ensure that the delivery of the vehicle to an authorised treatment facility in accordance with paragraph 3 occurs without any cost for the last holder and/or owner as a result of the vehicle's having no or a negative market value.
Member States shall take the necessary measures to ensure that producers meet all, or a significant part of, the costs of the implementation of this measure and/or take back end-of life vehicles under the same conditions as referred to in the first subparagraph.
Member States may provide that the delivery of end-of life vehicles is not fully free of charge if the end-of life vehicle does not contain the essential components of a vehicle, in particular the engine and the coachwork, or contains waste which has been added to the end-of life vehicle.
The Commission shall regularly monitor the implementation of the first subparagraph to ensure that it does not result in market distortions, and if necessary shall propose to the European Parliament and the Council an amendment thereto.
5. Member States shall take the necessary measures to ensure that competent authorities mutually recognise and accept the certificates of destruction issued in other Member States in accordance with paragraph 3. To this end, the Commission shall draw up, not later than 21 October 2001 the minimum requirements for the certificate of destruction.
Article 6
Treatment
1. Member States shall take the necessary measures to ensure that all end-of life vehicles are stored (even temporarily) and treated in accordance with the general requirements laid down in Article 4 of Directive 75/442/EEC, and in compliance with the minimum technical requirements set out in Annex I to this Directive, without prejudice to national regulations on health and environment.
2. Member States shall take the necessary measures to ensure that any establishment or undertaking carrying out treatment operations obtains a permit from or be registered with the competent authorities, in compliance with Articles 9, 10 and 11 of Directive 75/442/EEC.
The derogation from the permit requirement referred to in Article 11(1)(b) of Directive 75/442/EEC may apply to recovery operations concerning waste of end-of life vehicles after they have been treated according to Annex 1(3) to this Directive if there is an inspection by the competent authorities before the registration. This inspection shall verify:
(a) type and quantities of waste to be treated;
(b) general technical requirements to be complied with;
(c) safety precautions to be taken,
in order to achieve the objectives referred to in Article 4 of Directive 75/442/EEC. This inspection shall take place once a year. Member States using the derogation shall send the results to the Commission.
3. Member States shall take the necessary measures to ensure that any establishment or undertaking carrying out treatment operations fulfils at least the following obligations in accordance with Annex I:
(a) end-of life vehicles shall be stripped before further treatment or other equivalent arrangements are made in order to reduce any adverse impact on the environment. Components or materials labelled or otherwise made identifiable in accordance with Article 4(2) shall be stripped before further treatment;
(b) hazardous materials and components shall be removed and segregated in a selective way so as not to contaminate subsequent shredder waste from end-of life vehicles;
(c) stripping operations and storage shall be carried out in such a way as to ensure the suitability of vehicle components for reuse and recovery, and in particular for recycling.
Treatment operations for depollution of end-of life vehicles as referred to in Annex I(3) shall be carried out as soon as possible.
4. Member States shall take the necessary measures to ensure that the permit or registration referred to in paragraph 2 includes all conditions necessary for compliance with the requirements of paragraphs 1, 2 and 3.
5. Member States shall encourage establishments or undertakings, which carry out treatment operations to introduce, certified environmental management systems.
Article 7
Reuse and recovery
1. Member States shall take the necessary measures to encourage the reuse of components which are suitable for reuse, the recovery of components which cannot be reused and the giving of preference to recycling when environmentally viable, without prejudice to requirements regarding the safety of vehicles and environmental requirements such as air emissions and noise control.
2. Member States shall take the necessary measures to ensure that the following targets are attained by economic operators:
(a) no later than 1 January 2006, for all end-of life vehicles, the reuse and recovery shall be increased to a minimum of 85 % by an average weight per vehicle and year. Within the same time limit the reuse and recycling shall be increased to a minimum of 80 % by an average weight per vehicle and year;
for vehicles produced before 1 January 1980, Member States may lay down lower targets, but not lower than 75 % for reuse and recovery and not lower than 70 % for reuse and recycling. Member States making use of this subparagraph shall inform the Commission and the other Member States of the reasons therefor;
(b) no later than 1 January 2015, for all end-of life vehicles, the reuse and recovery shall be increased to a minimum of 95 % by an average weight per vehicle and year. Within the same time limit, the re-use and recycling shall be increased to a minimum of 85 % by an average weight per vehicle and year.
By 31 December 2005 at the latest the European Parliament and the Council shall re-examine the targets referred to in paragraph (b) on the basis of a report of the Commission, accompanied by a proposal. In its report the Commission shall take into account the development of the material composition of vehicles and any other relevant environmental aspects related to vehicles.
The Commission shall, in accordance with the procedure laid down in Article 11, establish the detailed rules necessary to control compliance of Member States with the targets set out in this paragraph. In doing so the Commission shall take into account all relevant factors, inter alia the availability of data and the issue of exports and imports of end-of life vehicles. The Commission shall take this measure not later than 21 October 2002.
3. On the basis of a proposal from the Commission, the European Parliament and the Council shall establish targets for reuse and recovery and for reuse and recycling for the years beyond 2015.
4. In order to prepare an amendment to Directive 70/156/EEC, the Commission shall promote the preparation of European standards relating to the dismantlability, recoverability and recyclability of vehicles. Once the standards are agreed, but in any case no later than by the end of 2001, the European Parliament and the Council, on the basis of a proposal from the Commission, shall amend Directive 70/156/EEC so that vehicles type-approved in accordance with that Directive and put on the market after three years after the amendment of the Directive 70/156/EEC are re-usable and/or recyclable to a minimum of 85 % by weight per vehicle and are re-usable and/or recoverable to a minimum of 95 % by weight per vehicle.
5. In proposing the amendment to Directive 70/156/EEC relating to the ability to be dismantled, recoverability and recyclability of vehicles, the Commission shall take into account as appropriate the need to ensure that the reuse of components does not give rise to safety or environmental hazards.
Article 8
Coding standards/dismantling information
1. Member States shall take the necessary measures to ensure that producers, in concert with material and equipment manufacturers, use component and material coding standards, in particular to facilitate the identification of those components and materials which are suitable for reuse and recovery.
2. Not later than 21 October 2001 the Commission shall, in accordance with the procedure laid down in Article 11 establish the standards referred to in paragraph 1 of this Article. In so doing, the Commission shall take account of the work going on in this area in the relevant international forums and contribute to this work as appropriate.
3. Member States shall take the necessary measures to ensure that producers provide dismantling information for each type of new vehicle put on the market within six months after the vehicle is put on the market. This information shall identify, as far as it is needed by treatment facilities in order to comply with the provisions of this Directive, the different vehicle components and materials, and the location of all hazardous substances in the vehicles, in particular with a view to the achievement of the objectives laid down in Article 7.
4. Without prejudice to commercial and industrial confidentiality, Member States shall take the necessary measures to ensure that manufacturers of components used in vehicles make available to authorised treatment facilities, as far as it is requested by these facilities, appropriate information concerning dismantling, storage and testing of components which can be reused.
Article 9
Reporting and information
1. At three-year intervals Member States shall send a report to the Commission on the implementation of this Directive. The report shall be drawn up on the basis of a questionnaire or outline drafted by the Commission in accordance with the procedure laid down in Article 6 of Directive 91/692/EEC(8) with a view to establishing databases on end-of life vehicles and their treatment. The report shall contain relevant information on possible changes in the structure of motor vehicle dealing and of the collection, dismantling, shredding, recovery and recycling industries, leading to any distortion of competition between or within Member States. The questionnaire or outline shall be sent to the Member States six months before the start of the period covered by the report. The report shall be made to the Commission within nine months of the end of the three-year period covered by it.
The first report shall cover the period of three years from 21 April 2002.
Based on the above information, the Commission shall publish a report on the implementation of this Directive within nine months of receiving the reports from the Member States.
2. Member States shall require in each case the relevant economic operators to publish information on:
- the design of vehicles and their components with a view to their recoverability and recyclability,
- the environmentally sound treatment of end-of life vehicles, in particular the removal of all fluids and dismantling,
- the development and optimisation of ways to reuse, recycle and recover end-of life vehicles and their components,
- the progress achieved with regard to recovery and recycling to reduce the waste to be disposed of and to increase the recovery and recycling rates.
The producer must make this information accessible to the prospective buyers of vehicles. It shall be included in promotional literature used in the marketing of the new vehicle.
Article 10
Implementation
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 21 April 2002. They shall immediately inform the Commission thereof.
When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by Member States.
2. Member States shall communicate to the Commission the text of the main provisions of domestic law, which they adopt in the field governed by this Directive.
3. Provided that the objectives set out in this Directive are achieved, Member States may transpose the provisions set out in Articles 4(1), 5(1), 7(1), 8(1), 8(3) and 9(2) and specify the detailed rules of implementation of Article 5(4) by means of agreements between the competent authorities and the economic sectors concerned. Such agreements shall meet the following requirements
(a) agreements shall be enforceable;
(b) agreements need to specify objectives with the corresponding deadlines;
(c) agreements shall be published in the national official journal or an official document equally accessible to the public and transmitted to the Commission;
(d) the results achieved under an agreement shall be monitored regularly, reported to the competent authorities and to the Commission and made available to the public under the conditions set out in the agreement;
(e) the competent authorities shall make provisions to examine the progress reached under an agreement;
(f) in case of non-compliance with an agreement Member States must implement the relevant provisions of this Directive by legislative, regulatory or administrative measures.
Article 11
Committee procedure
1. The Commission shall be assisted by the committee established by Article 18 of Directive 75/442/EEC, hereinafter referred to as "the Committee".
2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The Committee shall adopt its rules of procedure.
4. The Commission, according to the procedure laid down in this Article, shall adopt:
(a) the minimum requirements, as referred to in Article 5(5), for the certificate of destruction;
(b) the detailed rules referred to in Article 7(2), third subparagraph;
(c) the formats relating to the database system referred to in Article 9;
(d) the amendments necessary for adapting the Annexes to this Directive to scientific and technical progress.
Article 12
Entry into force
1. This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
2. Article 5(4) shall apply:
- as from 1 July 2002 for vehicles put on the market as from this date,
- as from 1 January 2007 for vehicles put on the market before the date referred to in the first indent.
3. Member States may apply Article 5(4) in advance of the dates set out in paragraph 2.
Article 13
Addressees
This Directive is addressed to the Member States.
|
[
"UKSI20101095",
"UKSI20050263",
"UKSI20101094"
] |
32000L0028
|
2000
|
Directive 2000/28/EC of the European Parliament and of the Council of 18 September 2000 amending Directive 2000/12/EC relating to the taking up and pursuit of the business of credit institutions
Having regard to the Treaty establishing the European Community, and in particular the first and third sentences of Article 47(2) thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Having regard to the opinion of the European Central Bank(3),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(4),
Whereas:
(1) In accordance with the objectives of the Treaty, it is desirable to promote harmonious development of the activities of credit institutions throughout the Community, in particular as regards the issuance of electronic money.
(2) Certain institutions limit their activity primarily to the issuance of electronic money. To avoid any distortion of competition between electronic money issuers, even as regards application of monetary policy measures, it is advisable that these institutions, subject to suitable specific provisions taking into account their special characteristics, be brought within the scope of Directive 2000/12/EC(5).
(3) It is advisable, consequently, to extend to these institutions the definition of credit institutions provided for in Article 1 of Directive 2000/12/EC.
(4) Directive 2000/46/EC of the European Parliament and of the Council of 18 September 2000 on the taking up, pursuit and prudential supervision of the business of electronic money institutions(6) defines electronic money institutions.
(5) It is necessary for electronic money to be redeemable to ensure bearer confidence,
Article 1
Directive 2000/12/EC is hereby amended as follows:
1. Article 1, point 1, first subparagraph shall be replaced by the following text:
"1. 'Credit institution' shall mean:
(a) an undertaking whose business is to receive deposits or other repayable funds from the public and to grant credits for its own account; or
(b) an electronic money institution within the meaning of Directive 2000/46/EC of the European Parliament and of the Council of 18 September 2000 on the taking up, pursuit and prudential supervision of the business of electronic money institutions(7)."
2. The following Article shall be added to Title V:
"Article 33a
Article 3 of Directive 2000/46/EC shall apply to credit institutions."
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 27 April 2002. They shall immediately inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20020682",
"UKSI20020765"
] |
32000L0057
|
2000
|
Commission Directive 2000/57/EC of 22 September 2000 amending the Annexes to Council Directives 76/895/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on fruit and vegetables and certain products of plant origin, including fruit and vegetables respectively (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 76/895/EEC of 23 November 1976 on the fixing of maximum levels for pesticide residues in and on fruit and vegetables(1), as last amended by Commission Directive 2000/24/EC(2), and in particular Article 5 thereof,
Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in certain products of plant origin, including fruit and vegetables(3), as last amended by Directive 2000/42/EC(4),
Having regard to Council Directive 91/414/EEC of 15 July 1991 on the placing of plant protection products on the market(5), as last amended by Commission Directive 2000/10/EC(6), and in particular Article 7 thereof,
Whereas:
(1) In accordance with the provisions of Directive 91/414/EEC, authorisations of plant protection products for use on specific crops are the responsibility of the Member States. Such authorisations are required to be based on the evaluation of effects on human and animal health and influence on the environment. Elements to be taken into account in such evaluations include operator and bystander exposure and impact on the terrestrial, aquatic and aerial environments, as well as impact on humans and animals through consumption of residues on treated crops.
(2) For products of plant origin, including fruit and vegetables, maximum residue levels generally reflect the use of minimum quantities of pesticides to achieve effective protection of plants, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable, in particular in view of the protection of the environment and in terms of estimated dietary intake.
(3) Maximum residue levels are fixed at the lower limit of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residue in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported with such necessary data.
(4) Maximum residue levels for pesticides should be kept under review. The levels may be changed to take account of new uses, new information and data and, in particular, should be urgently reconsidered with a view to reduction if concerns about dietary exposure of consumers, based on new or reviewed information, are brought to the attention of the Commission, in particular in implementation of Article 4 of Directive 76/895 and Article 8 of Directive 90/642/EEC.
(5) Information on new or changed uses of the pesticides covered by this Directive have been notified to the Commission. The information supporting these uses has been evaluated and it is appropriate to modify the existing maximum residue limits in the Annexes of the Directives.
(6) The lifetime exposure of consumers to these pesticides via food products that may contain residues of these pesticides, has been assessed and evaluated in accordance with the procedures and practices used within the European Community, taking account of guidelines published by the World Health Organistion(7) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceedence of the acceptable daily intakes.
(7) Where appropriate, the acute exposure of consumers to these pesticides via each of the food products that may contain residues of these pesticides has been assessed and evaluated in accordance with the procedures and practices currently used within the European Community, taking account of recommendations published by the World Health Organisation, and no acute intake concerns have been identified.
(8) Article 4 of Commission Directive 98/82/EC(8), on the setting of maximum residue levels, fixed temporary maximum residue levels for vinclozolin for some commodities in advance of the adoption for all agricultural products of reviewed maximum residue levels on the basis of the evaluation works under the provisions of Article 8(2) of Directive 91/414/EEC. This evaluation is not yet complete. It is nonetheless appropriate to reduce the exposure of consumers to residues of vinclozolin by reducing the maximum residue levels of vinclozolin for certain commodities. It is also appropriate that these revised levels be fixed on a temporary basis pending the completion of the said evaluation work.
(9) All of the pesticides for which maximum residue limits are being fixed by this Directive need to be evaluated in the framework of Directive 91/414/EEC. The maximum residue limits fixed by this Directive for each pesticide will need to be reviewed case by case on the basis of eventual Commission decisions following the evaluation work carried out under Article 8(2) of Directive 91/414/EEC.
(10) The Community's trading partners have been consulted about the levels set out in this Directive through the World Trade Organisation and their comments on these levels have been considered. The possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the Commission on the basis of the submission of acceptable data.
(11) The opinions of the Scientific Committee for Plants, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides, have been taken into account.
(12) This Directive is in accordance with the opinion of the Standing Committee on Plant Health;
Article 1
In Annex II of Directive 76/895/EEC the entry of "3" for folpet in wine grapes is replaced by "10".
Article 2
Annex II of Directive 90/642/EEC is modified as follows:
1. the entry of "1" for maleic hydrazide in carrots and in parsnips is replaced by "30";
2. the entry of "0,1" for glyphosate in cottonseed is replaced by "10";
3. the entries of "0,05" for the dithiocarbamates maneb, mancozeb, metiram, propineb and zineb in olives are replaced by "5";
4. a new entry is made for the pesticide residue diphenylamine with the following maximum residue limits:
>TABLE>
5. The entries for vinclozolin of "3" and "2" for tomatoes and peaches are replaced by "0,05*" and "0,05*" respectively. These revised values are fixed on a temporary basis.
Article 3
This Directive enters into force on the 20th day following its publication in the Official Journal of the European Communities.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 March 2001 at the latest. They shall forthwith inform the Commission thereof.
They shall apply these provisions as of 1 April 2001.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20011113"
] |
32000L0058
|
2000
|
Commission Directive 2000/58/EC of 22 September 2000 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(1), as last amended by Commission Directive 2000/48/EC(2), and in particular Article 10 thereof,
Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin(3), as last amended by Commission Directive 2000/42/EC(4), and in particular Article 10 thereof,
Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin including fruit and vegetables(5), as last amended by Directive 2000/57/EC(6), and in particular Article 7 thereof,
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(7), as last amended by Commission Directive 2000/10/EC(8), and in particular Article 4(1)(f) thereof,
Whereas:
(1) The new active substance, kresoxim-methyl, was included in Annex I to Directive 91/414/EEC by Commission Directive 1999/1/EC(9) for use as fungicide only, without specifying particular conditions having an impact on crops which may be treated with plant protection products containing kresoxim methyl.
(2) The said inclusion in Annex I was based on assessment of the information submitted concerning proposed use as fungicide on cereals, pome fruit and vines. Information relating to other uses has been submitted by certain Member States in accordance with the requirements of Article 4(1)(f) of Directive 91/414/EEC. The information available has been reviewed and is sufficient to fix certain maximum residue levels.
(3) Where no Community maximum residue level or provisional MRL exists Member States shall establish a national provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC. The information available has been reviewed and is sufficient to fix certain maximum residue levels.
(4) At the inclusion in Annex I to Directive 91/414/EEC, the technical and scientific evaluation of kresoxim methyl was finalised on 16 October 1998 in the format of the Commission review report for kresoxim methyl. In this review report the acceptable daily intake (ADI) for kresoxim methyl was set at 0,4 mg/kg of body weight. The lifetime exposure of consumers of food products treated with kresoxim methyl has been assessed and evaluated in accordance with the procedures and practices used within the European Community, taking account of guidelines published by the World Health Organisation(10) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceeding of this ADI.
(5) Acute toxic effects requiring the setting of an acute reference dose were not noted during the evaluation and discussion that preceded the inclusion of kresoxim methyl in Annex I to Directive 91/414/EEC.
(6) For certain agricultural products the use conditions for kresoxim methyl were already defined in a manner which permits the establishing of definitive maximum residue levels.
(7) To ensure that the consumer is adequately protected from exposure to residues in or on products for which no authorisations have been granted, it is prudent to set provisional maximum residue levels at the lower limit of analytical determination for all those products covered by Directives 86/362/EEC, 86/363/EEC and 90/642/EEC. The setting at Community level of such provisional maximum residue levels does not prevent the Member States from establishing provisional maximum residue levels for kresoxim methyl in accordance with Article 4(1)(f) of Directive 91/414/EEC and in accordance with Annex VI to Directive 91/414/EEC in particular Part B, Section 2.4.2.3 to this Annex. Four years is considered a sufficient period of time during which to establish most further uses of kresoxim methyl. After that period these provisional maximum residue levels should become definitive;
(8) The Community's trading partners have been consulted aobut the levels set out in this Directive through the World Trade Organisation and their comments on these levels have been considered. The possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the Commission on the basis of the submission of acceptable data.
(9) The opinions of the Scientific Committee for Plants, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides, have been taken into account.
(10) This Directive is in accordance with the opinion of the Standing Committee on Plant Health,
Article 1
The following is added to Part A of Annex II to Directive 86/362/EEC:
">TABLE>"
Article 2
The following is added to Part of Annex II to Directive 86/363/EEC:
">TABLE>"
Article 3
The maximum residue levels for kresoxim methyl in the Annex to this Directive are added to Annex II to Directive 90/642/EEC.
Article 4
1. Where the maximum residue levels for kresoxim methyl are indicated as "(p)", this means that they are provisional (p) in accordance with the provisions of Article 4(1)(f) of Directive 91/414/EEC.
2. Four years after the entry into force of this Directive, provisional maximum residue levels for kresoxim methyl in the Annexes cease to be provisional and become definitive in the sense of Article 4(1) of Directives 86/362/EEC and 86/363/EEC or Article 3 of Directive 90/642/EEC respectively.
Article 5
This Directive enters into force on the 20th day following its publication in the Official Journal of the European Communities.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 March 2001 at the latest. They shall forthwith inform the Commission thereof.
They shall apply these provisions as of 1 April 2001.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 6
This Directive is addressed to the Member States.
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[
"UKSI20011113"
] |
32000L0060
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2000
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Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy
Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
Having regard to the opinion of the Committee of the Regions(3),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(4), and in the light of the joint text approved by the Conciliation Committee on 18 July 2000,
Whereas:
(1) Water is not a commercial product like any other but, rather, a heritage which must be protected, defended and treated as such.
(2) The conclusions of the Community Water Policy Ministerial Seminar in Frankfurt in 1988 highlighted the need for Community legislation covering ecological quality. The Council in its resolution of 28 June 1988(5) asked the Commission to submit proposals to improve ecological quality in Community surface waters.
(3) The declaration of the Ministerial Seminar on groundwater held at The Hague in 1991 recognised the need for action to avoid long-term deterioration of freshwater quality and quantity and called for a programme of actions to be implemented by the year 2000 aiming at sustainable management and protection of freshwater resources. In its resolutions of 25 February 1992(6), and 20 February 1995(7), the Council requested an action programme for groundwater and a revision of Council Directive 80/68/EEC of 17 December 1979 on the protection of groundwater against pollution caused by certain dangerous substances(8), as part of an overall policy on freshwater protection.
(4) Waters in the Community are under increasing pressure from the continuous growth in demand for sufficient quantities of good quality water for all purposes. On 10 November 1995, the European Environment Agency in its report "Environment in the European Union - 1995" presented an updated state of the environment report, confirming the need for action to protect Community waters in qualitative as well as in quantitative terms.
(5) On 18 December 1995, the Council adopted conclusions requiring, inter alia, the drawing up of a new framework Directive establishing the basic principles of sustainable water policy in the European Union and inviting the Commission to come forward with a proposal.
(6) On 21 February 1996 the Commission adopted a communication to the European Parliament and the Council on European Community water policy setting out the principles for a Community water policy.
(7) On 9 September 1996 the Commission presented a proposal for a Decision of the European Parliament and of the Council on an action programme for integrated protection and management of groundwater(9). In that proposal the Commission pointed to the need to establish procedures for the regulation of abstraction of freshwater and for the monitoring of freshwater quality and quantity.
(8) On 29 May 1995 the Commission adopted a communication to the European Parliament and the Council on the wise use and conservation of wetlands, which recognised the important functions they perform for the protection of water resources.
(9) It is necessary to develop an integrated Community policy on water.
(10) The Council on 25 June 1996, the Committee of the Regions on 19 September 1996, the Economic and Social Committee on 26 September 1996, and the European Parliament on 23 October 1996 all requested the Commission to come forward with a proposal for a Council Directive establishing a framework for a European water policy.
(11) As set out in Article 174 of the Treaty, the Community policy on the environment is to contribute to pursuit of the objectives of preserving, protecting and improving the quality of the environment, in prudent and rational utilisation of natural resources, and to be based on the precautionary principle and on the principles that preventive action should be taken, environmental damage should, as a priority, be rectified at source and that the polluter should pay.
(12) Pursuant to Article 174 of the Treaty, in preparing its policy on the environment, the Community is to take account of available scientific and technical data, environmental conditions in the various regions of the Community, and the economic and social development of the Community as a whole and the balanced development of its regions as well as the potential benefits and costs of action or lack of action.
(13) There are diverse conditions and needs in the Community which require different specific solutions. This diversity should be taken into account in the planning and execution of measures to ensure protection and sustainable use of water in the framework of the river basin. Decisions should be taken as close as possible to the locations where water is affected or used. Priority should be given to action within the responsibility of Member States through the drawing up of programmes of measures adjusted to regional and local conditions.
(14) The success of this Directive relies on close cooperation and coherent action at Community, Member State and local level as well as on information, consultation and involvement of the public, including users.
(15) The supply of water is a service of general interest as defined in the Commission communication on services of general interest in Europe(10).
(16) Further integration of protection and sustainable management of water into other Community policy areas such as energy, transport, agriculture, fisheries, regional policy and tourism is necessary. This Directive should provide a basis for a continued dialogue and for the development of strategies towards a further integration of policy areas. This Directive can also make an important contribution to other areas of cooperation between Member States, inter alia, the European spatial development perspective (ESDP).
(17) An effective and coherent water policy must take account of the vulnerability of aquatic ecosystems located near the coast and estuaries or in gulfs or relatively closed seas, as their equilibrium is strongly influenced by the quality of inland waters flowing into them. Protection of water status within river basins will provide economic benefits by contributing towards the protection of fish populations, including coastal fish populations.
(18) Community water policy requires a transparent, effective and coherent legislative framework. The Community should provide common principles and the overall framework for action. This Directive should provide for such a framework and coordinate and integrate, and, in a longer perspective, further develop the overall principles and structures for protection and sustainable use of water in the Community in accordance with the principles of subsidiarity.
(19) This Directive aims at maintaining and improving the aquatic environment in the Community. This purpose is primarily concerned with the quality of the waters concerned. Control of quantity is an ancillary element in securing good water quality and therefore measures on quantity, serving the objective of ensuring good quality, should also be established.
(20) The quantitative status of a body of groundwater may have an impact on the ecological quality of surface waters and terrestrial ecosystems associated with that groundwater body.
(21) The Community and Member States are party to various international agreements containing important obligations on the protection of marine waters from pollution, in particular the Convention on the Protection of the Marine Environment of the Baltic Sea Area, signed in Helsinki on 9 April 1992 and approved by Council Decision 94/157/EC(11), the Convention for the Protection of the Marine Environment of the North-East Atlantic, signed in Paris on 22 September 1992 and approved by Council Decision 98/249/EC(12), and the Convention for the Protection of the Mediterranean Sea Against Pollution, signed in Barcelona on 16 February 1976 and approved by Council Decision 77/585/EEC(13), and its Protocol for the Protection of the Mediterranean Sea Against Pollution from Land-Based Sources, signed in Athens on 17 May 1980 and approved by Council Decision 83/101/EEC(14). This Directive is to make a contribution towards enabling the Community and Member States to meet those obligations.
(22) This Directive is to contribute to the progressive reduction of emissions of hazardous substances to water.
(23) Common principles are needed in order to coordinate Member States' efforts to improve the protection of Community waters in terms of quantity and quality, to promote sustainable water use, to contribute to the control of transboundary water problems, to protect aquatic ecosystems, and terrestrial ecosystems and wetlands directly depending on them, and to safeguard and develop the potential uses of Community waters.
(24) Good water quality will contribute to securing the drinking water supply for the population.
(25) Common definitions of the status of water in terms of quality and, where relevant for the purpose of the environmental protection, quantity should be established. Environmental objectives should be set to ensure that good status of surface water and groundwater is achieved throughout the Community and that deterioration in the status of waters is prevented at Community level.
(26) Member States should aim to achieve the objective of at least good water status by defining and implementing the necessary measures within integrated programmes of measures, taking into account existing Community requirements. Where good water status already exists, it should be maintained. For groundwater, in addition to the requirements of good status, any significant and sustained upward trend in the concentration of any pollutant should be identified and reversed.
(27) The ultimate aim of this Directive is to achieve the elimination of priority hazardous substances and contribute to achieving concentrations in the marine environment near background values for naturally occurring substances.
(28) Surface waters and groundwaters are in principle renewable natural resources; in particular, the task of ensuring good status of groundwater requires early action and stable long-term planning of protective measures, owing to the natural time lag in its formation and renewal. Such time lag for improvement should be taken into account in timetables when establishing measures for the achievement of good status of groundwater and reversing any significant and sustained upward trend in the concentration of any pollutant in groundwater.
(29) In aiming to achieve the objectives set out in this Directive, and in establishing a programme of measures to that end, Member States may phase implementation of the programme of measures in order to spread the costs of implementation.
(30) In order to ensure a full and consistent implementation of this Directive any extensions of timescale should be made on the basis of appropriate, evident and transparent criteria and be justified by the Member States in the river basin management plans.
(31) In cases where a body of water is so affected by human activity or its natural condition is such that it may be unfeasible or unreasonably expensive to achieve good status, less stringent environmental objectives may be set on the basis of appropriate, evident and transparent criteria, and all practicable steps should be taken to prevent any further deterioration of the status of waters.
(32) There may be grounds for exemptions from the requirement to prevent further deterioration or to achieve good status under specific conditions, if the failure is the result of unforeseen or exceptional circumstances, in particular floods and droughts, or, for reasons of overriding public interest, of new modifications to the physical characteristics of a surface water body or alterations to the level of bodies of groundwater, provided that all practicable steps are taken to mitigate the adverse impact on the status of the body of water.
(33) The objective of achieving good water status should be pursued for each river basin, so that measures in respect of surface water and groundwaters belonging to the same ecological, hydrological and hydrogeological system are coordinated.
(34) For the purposes of environmental protection there is a need for a greater integration of qualitative and quantitative aspects of both surface waters and groundwaters, taking into account the natural flow conditions of water within the hydrological cycle.
(35) Within a river basin where use of water may have transboundary effects, the requirements for the achievement of the environmental objectives established under this Directive, and in particular all programmes of measures, should be coordinated for the whole of the river basin district. For river basins extending beyond the boundaries of the Community, Member States should endeavour to ensure the appropriate coordination with the relevant non-member States. This Directive is to contribute to the implementation of Community obligations under international conventions on water protection and management, notably the United Nations Convention on the protection and use of transboundary water courses and international lakes, approved by Council Decision 95/308/EC(15) and any succeeding agreements on its application.
(36) It is necessary to undertake analyses of the characteristics of a river basin and the impacts of human activity as well as an economic analysis of water use. The development in water status should be monitored by Member States on a systematic and comparable basis throughout the Community. This information is necessary in order to provide a sound basis for Member States to develop programmes of measures aimed at achieving the objectives established under this Directive.
(37) Member States should identify waters used for the abstraction of drinking water and ensure compliance with Council Directive 80/778/EEC of 15 July 1980 relating to the quality of water intended for human consumption(16).
(38) The use of economic instruments by Member States may be appropriate as part of a programme of measures. The principle of recovery of the costs of water services, including environmental and resource costs associated with damage or negative impact on the aquatic environment should be taken into account in accordance with, in particular, the polluter-pays principle. An economic analysis of water services based on long-term forecasts of supply and demand for water in the river basin district will be necessary for this purpose.
(39) There is a need to prevent or reduce the impact of incidents in which water is accidentally polluted. Measures with the aim of doing so should be included in the programme of measures.
(40) With regard to pollution prevention and control, Community water policy should be based on a combined approach using control of pollution at source through the setting of emission limit values and of environmental quality standards.
(41) For water quantity, overall principles should be laid down for control on abstraction and impoundment in order to ensure the environmental sustainability of the affected water systems.
(42) Common environmental quality standards and emission limit values for certain groups or families of pollutants should be laid down as minimum requirements in Community legislation. Provisions for the adoption of such standards at Community level should be ensured.
(43) Pollution through the discharge, emission or loss of priority hazardous substances must cease or be phased out. The European Parliament and the Council should, on a proposal from the Commission, agree on the substances to be considered for action as a priority and on specific measures to be taken against pollution of water by those substances, taking into account all significant sources and identifying the cost-effective and proportionate level and combination of controls.
(44) In identifying priority hazardous substances, account should be taken of the precautionary principle, relying in particular on the determination of any potentially adverse effects of the product and on a scientific assessment of the risk.
(45) Member States should adopt measures to eliminate pollution of surface water by the priority substances and progressively to reduce pollution by other substances which would otherwise prevent Member States from achieving the objectives for the bodies of surface water.
(46) To ensure the participation of the general public including users of water in the establishment and updating of river basin management plans, it is necessary to provide proper information of planned measures and to report on progress with their implementation with a view to the involvement of the general public before final decisions on the necessary measures are adopted.
(47) This Directive should provide mechanisms to address obstacles to progress in improving water status when these fall outside the scope of Community water legislation, with a view to developing appropriate Community strategies for overcoming them.
(48) The Commission should present annually an updated plan for any initiatives which it intends to propose for the water sector.
(49) Technical specifications should be laid down to ensure a coherent approach in the Community as part of this Directive. Criteria for evaluation of water status are an important step forward. Adaptation of certain technical elements to technical development and the standardisation of monitoring, sampling and analysis methods should be adopted by committee procedure. To promote a thorough understanding and consistent application of the criteria for characterisation of the river basin districts and evaluation of water status, the Commission may adopt guidelines on the application of these criteria.
(50) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(17).
(51) The implementation of this Directive is to achieve a level of protection of waters at least equivalent to that provided in certain earlier acts, which should therefore be repealed once the relevant provisions of this Directive have been fully implemented.
(52) The provisions of this Directive take over the framework for control of pollution by dangerous substances established under Directive 76/464/EEC(18). That Directive should therefore be repealed once the relevant provisions of this Directive have been fully implemented.
(53) Full implementation and enforcement of existing environmental legislation for the protection of waters should be ensured. It is necessary to ensure the proper application of the provisions implementing this Directive throughout the Community by appropriate penalties provided for in Member States' legislation. Such penalties should be effective, proportionate and dissuasive,
Article 1
Purpose
The purpose of this Directive is to establish a framework for the protection of inland surface waters, transitional waters, coastal waters and groundwater which:
(a) prevents further deterioration and protects and enhances the status of aquatic ecosystems and, with regard to their water needs, terrestrial ecosystems and wetlands directly depending on the aquatic ecosystems;
(b) promotes sustainable water use based on a long-term protection of available water resources;
(c) aims at enhanced protection and improvement of the aquatic environment, inter alia, through specific measures for the progressive reduction of discharges, emissions and losses of priority substances and the cessation or phasing-out of discharges, emissions and losses of the priority hazardous substances;
(d) ensures the progressive reduction of pollution of groundwater and prevents its further pollution, and
(e) contributes to mitigating the effects of floods and droughts
and thereby contributes to:
- the provision of the sufficient supply of good quality surface water and groundwater as needed for sustainable, balanced and equitable water use,
- a significant reduction in pollution of groundwater,
- the protection of territorial and marine waters, and
- achieving the objectives of relevant international agreements, including those which aim to prevent and eliminate pollution of the marine environment, by Community action under Article 16(3) to cease or phase out discharges, emissions and losses of priority hazardous substances, with the ultimate aim of achieving concentrations in the marine environment near background values for naturally occurring substances and close to zero for man-made synthetic substances.
Article 2
Definitions
For the purposes of this Directive the following definitions shall apply:
1. "Surface water" means inland waters, except groundwater; transitional waters and coastal waters, except in respect of chemical status for which it shall also include territorial waters.
2. "Groundwater" means all water which is below the surface of the ground in the saturation zone and in direct contact with the ground or subsoil.
3. "Inland water" means all standing or flowing water on the surface of the land, and all groundwater on the landward side of the baseline from which the breadth of territorial waters is measured.
4. "River" means a body of inland water flowing for the most part on the surface of the land but which may flow underground for part of its course.
5. "Lake" means a body of standing inland surface water.
6. "Transitional waters" are bodies of surface water in the vicinity of river mouths which are partly saline in character as a result of their proximity to coastal waters but which are substantially influenced by freshwater flows.
7. "Coastal water" means surface water on the landward side of a line, every point of which is at a distance of one nautical mile on the seaward side from the nearest point of the baseline from which the breadth of territorial waters is measured, extending where appropriate up to the outer limit of transitional waters.
8. "Artificial water body" means a body of surface water created by human activity.
9. "Heavily modified water body"
means a body of surface water which as a result of physical alterations by human activity is substantially changed in character, as designated by the Member State in accordance with the provisions of Annex II.
10. "Body of surface water" means a discrete and significant element of surface water such as a lake, a reservoir, a stream, river or canal, part of a stream, river or canal, a transitional water or a stretch of coastal water.
11. "Aquifer" means a subsurface layer or layers of rock or other geological strata of sufficient porosity and permeability to allow either a significant flow of groundwater or the abstraction of significant quantities of groundwater.
12. "Body of groundwater" means a distinct volume of groundwater within an aquifer or aquifers.
13. "River basin" means the area of land from which all surface run-off flows through a sequence of streams, rivers and, possibly, lakes into the sea at a single river mouth, estuary or delta.
14. "Sub-basin" means the area of land from which all surface run-off flows through a series of streams, rivers and, possibly, lakes to a particular point in a water course (normally a lake or a river confluence).
15. "River basin district" means the area of land and sea, made up of one or more neighbouring river basins together with their associated groundwaters and coastal waters, which is identified under Article 3(1) as the main unit for management of river basins.
16. "Competent Authority" means an authority or authorities identified under Article 3(2) or 3(3).
17. "Surface water status" is the general expression of the status of a body of surface water, determined by the poorer of its ecological status and its chemical status.
18. "Good surface water status" means the status achieved by a surface water body when both its ecological status and its chemical status are at least "good".
19. "Groundwater status" is the general expression of the status of a body of groundwater, determined by the poorer of its quantitative status and its chemical status.
20. "Good groundwater status" means the status achieved by a groundwater body when both its quantitative status and its chemical status are at least "good".
21. "Ecological status" is an expression of the quality of the structure and functioning of aquatic ecosystems associated with surface waters, classified in accordance with Annex V.
22. "Good ecological status" is the status of a body of surface water, so classified in accordance with Annex V.
23. "Good ecological potential" is the status of a heavily modified or an artificial body of water, so classified in accordance with the relevant provisions of Annex V.
24. "Good surface water chemical status" means the chemical status required to meet the environmental objectives for surface waters established in Article 4(1)(a), that is the chemical status achieved by a body of surface water in which concentrations of pollutants do not exceed the environmental quality standards established in Annex IX and under Article 16(7), and under other relevant Community legislation setting environmental quality standards at Community level.
25. "Good groundwater chemical status" is the chemical status of a body of groundwater, which meets all the conditions set out in table 2.3.2 of Annex V.
26. "Quantitative status" is an expression of the degree to which a body of groundwater is affected by direct and indirect abstractions.
27. "Available groundwater resource" means the long-term annual average rate of overall recharge of the body of groundwater less the long-term annual rate of flow required to achieve the ecological quality objectives for associated surface waters specified under Article 4, to avoid any significant diminution in the ecological status of such waters and to avoid any significant damage to associated terrestrial ecosystems.
28. "Good quantitative status" is the status defined in table 2.1.2 of Annex V.
29. "Hazardous substances" means substances or groups of substances that are toxic, persistent and liable to bio-accumulate, and other substances or groups of substances which give rise to an equivalent level of concern.
30. "Priority substances" means substances identified in accordance with Article 16(2) and listed in Annex X. Among these substances there are "priority hazardous substances" which means substances identified in accordance with Article 16(3) and (6) for which measures have to be taken in accordance with Article 16(1) and (8).
31. "Pollutant" means any substance liable to cause pollution, in particular those listed in Annex VIII.
32. "Direct discharge to groundwater" means discharge of pollutants into groundwater without percolation throughout the soil or subsoil.
33. "Pollution" means the direct or indirect introduction, as a result of human activity, of substances or heat into the air, water or land which may be harmful to human health or the quality of aquatic ecosystems or terrestrial ecosystems directly depending on aquatic ecosystems, which result in damage to material property, or which impair or interfere with amenities and other legitimate uses of the environment.
34. "Environmental objectives" means the objectives set out in Article 4.
35. "Environmental quality standard" means the concentration of a particular pollutant or group of pollutants in water, sediment or biota which should not be exceeded in order to protect human health and the environment.
36. "Combined approach" means the control of discharges and emissions into surface waters according to the approach set out in Article 10.
37. "Water intended for human consumption" has the same meaning as under Directive 80/778/EEC, as amended by Directive 98/83/EC.
38. "Water services" means all services which provide, for households, public institutions or any economic activity:
(a) abstraction, impoundment, storage, treatment and distribution of surface water or groundwater,
(b) waste-water collection and treatment facilities which subsequently discharge into surface water.
39. "Water use" means water services together with any other activity identified under Article 5 and Annex II having a significant impact on the status of water.
This concept applies for the purposes of Article 1 and of the economic analysis carried out according to Article 5 and Annex III, point (b).
40. "Emission limit values" means the mass, expressed in terms of certain specific parameters, concentration and/or level of an emission, which may not be exceeded during any one or more periods of time. Emission limit values may also be laid down for certain groups, families or categories of substances, in particular for those identified under Article 16.
The emission limit values for substances shall normally apply at the point where the emissions leave the installation, dilution being disregarded when determining them. With regard to indirect releases into water, the effect of a waste-water treatment plant may be taken into account when determining the emission limit values of the installations involved, provided that an equivalent level is guaranteed for protection of the environment as a whole and provided that this does not lead to higher levels of pollution in the environment.
41. "Emission controls" are controls requiring a specific emission limitation, for instance an emission limit value, or otherwise specifying limits or conditions on the effects, nature or other characteristics of an emission or operating conditions which affect emissions. Use of the term "emission control" in this Directive in respect of the provisions of any other Directive shall not be held as reinterpreting those provisions in any respect.
Article 3
Coordination of administrative arrangements within river basin districts
1. Member States shall identify the individual river basins lying within their national territory and, for the purposes of this Directive, shall assign them to individual river basin districts. Small river basins may be combined with larger river basins or joined with neighbouring small basins to form individual river basin districts where appropriate. Where groundwaters do not fully follow a particular river basin, they shall be identified and assigned to the nearest or most appropriate river basin district. Coastal waters shall be identified and assigned to the nearest or most appropriate river basin district or districts.
2. Member States shall ensure the appropriate administrative arrangements, including the identification of the appropriate competent authority, for the application of the rules of this Directive within each river basin district lying within their territory.
3. Member States shall ensure that a river basin covering the territory of more than one Member State is assigned to an international river basin district. At the request of the Member States involved, the Commission shall act to facilitate the assigning to such international river basin districts.
Each Member State shall ensure the appropriate administrative arrangements, including the identification of the appropriate competent authority, for the application of the rules of this Directive within the portion of any international river basin district lying within its territory.
4. Member States shall ensure that the requirements of this Directive for the achievement of the environmental objectives established under Article 4, and in particular all programmes of measures are coordinated for the whole of the river basin district. For international river basin districts the Member States concerned shall together ensure this coordination and may, for this purpose, use existing structures stemming from international agreements. At the request of the Member States involved, the Commission shall act to facilitate the establishment of the programmes of measures.
5. Where a river basin district extends beyond the territory of the Community, the Member State or Member States concerned shall endeavour to establish appropriate coordination with the relevant non-Member States, with the aim of achieving the objectives of this Directive throughout the river basin district. Member States shall ensure the application of the rules of this Directive within their territory.
6. Member States may identify an existing national or international body as competent authority for the purposes of this Directive.
7. Member States shall identify the competent authority by the date mentioned in Article 24.
8. Member States shall provide the Commission with a list of their competent authorities and of the competent authorities of all the international bodies in which they participate at the latest six months after the date mentioned in Article 24. For each competent authority the information set out in Annex I shall be provided.
9. Member States shall inform the Commission of any changes to the information provided according to paragraph 8 within three months of the change coming into effect.
Article 4
Environmental objectives
1. In making operational the programmes of measures specified in the river basin management plans:
(a) for surface waters
(i) Member States shall implement the necessary measures to prevent deterioration of the status of all bodies of surface water, subject to the application of paragraphs 6 and 7 and without prejudice to paragraph 8;
(ii) Member States shall protect, enhance and restore all bodies of surface water, subject to the application of subparagraph (iii) for artificial and heavily modified bodies of water, with the aim of achieving good surface water status at the latest 15 years after the date of entry into force of this Directive, in accordance with the provisions laid down in Annex V, subject to the application of extensions determined in accordance with paragraph 4 and to the application of paragraphs 5, 6 and 7 without prejudice to paragraph 8;
(iii) Member States shall protect and enhance all artificial and heavily modified bodies of water, with the aim of achieving good ecological potential and good surface water chemical status at the latest 15 years from the date of entry into force of this Directive, in accordance with the provisions laid down in Annex V, subject to the application of extensions determined in accordance with paragraph 4 and to the application of paragraphs 5, 6 and 7 without prejudice to paragraph 8;
(iv) Member States shall implement the necessary measures in accordance with Article 16(1) and (8), with the aim of progressively reducing pollution from priority substances and ceasing or phasing out emissions, discharges and losses of priority hazardous substances
without prejudice to the relevant international agreements referred to in Article 1 for the parties concerned;
(b) for groundwater
(i) Member States shall implement the measures necessary to prevent or limit the input of pollutants into groundwater and to prevent the deterioration of the status of all bodies of groundwater, subject to the application of paragraphs 6 and 7 and without prejudice to paragraph 8 of this Article and subject to the application of Article 11(3)(j);
(ii) Member States shall protect, enhance and restore all bodies of groundwater, ensure a balance between abstraction and recharge of groundwater, with the aim of achieving good groundwater status at the latest 15 years after the date of entry into force of this Directive, in accordance with the provisions laid down in Annex V, subject to the application of extensions determined in accordance with paragraph 4 and to the application of paragraphs 5, 6 and 7 without prejudice to paragraph 8 of this Article and subject to the application of Article 11(3)(j);
(iii) Member States shall implement the measures necessary to reverse any significant and sustained upward trend in the concentration of any pollutant resulting from the impact of human activity in order progressively to reduce pollution of groundwater.
Measures to achieve trend reversal shall be implemented in accordance with paragraphs 2, 4 and 5 of Article 17, taking into account the applicable standards set out in relevant Community legislation, subject to the application of paragraphs 6 and 7 and without prejudice to paragraph 8;
(c) for protected areas
Member States shall achieve compliance with any standards and objectives at the latest 15 years after the date of entry into force of this Directive, unless otherwise specified in the Community legislation under which the individual protected areas have been established.
2. Where more than one of the objectives under paragraph 1 relates to a given body of water, the most stringent shall apply.
3. Member States may designate a body of surface water as artificial or heavily modified, when:
(a) the changes to the hydromorphological characteristics of that body which would be necessary for achieving good ecological status would have significant adverse effects on:
(i) the wider environment;
(ii) navigation, including port facilities, or recreation;
(iii) activities for the purposes of which water is stored, such as drinking-water supply, power generation or irrigation;
(iv) water regulation, flood protection, land drainage, or
(v) other equally important sustainable human development activities;
(b) the beneficial objectives served by the artificial or modified characteristics of the water body cannot, for reasons of technical feasibility or disproportionate costs, reasonably be achieved by other means, which are a significantly better environmental option.
Such designation and the reasons for it shall be specifically mentioned in the river basin management plans required under Article 13 and reviewed every six years.
4. The deadlines established under paragraph 1 may be extended for the purposes of phased achievement of the objectives for bodies of water, provided that no further deterioration occurs in the status of the affected body of water when all of the following conditions are met:
(a) Member States determine that all necessary improvements in the status of bodies of water cannot reasonably be achieved within the timescales set out in that paragraph for at least one of the following reasons:
(i) the scale of improvements required can only be achieved in phases exceeding the timescale, for reasons of technical feasibility;
(ii) completing the improvements within the timescale would be disproportionately expensive;
(iii) natural conditions do not allow timely improvement in the status of the body of water.
(b) Extension of the deadline, and the reasons for it, are specifically set out and explained in the river basin management plan required under Article 13.
(c) Extensions shall be limited to a maximum of two further updates of the river basin management plan except in cases where the natural conditions are such that the objectives cannot be achieved within this period.
(d) A summary of the measures required under Article 11 which are envisaged as necessary to bring the bodies of water progressively to the required status by the extended deadline, the reasons for any significant delay in making these measures operational, and the expected timetable for their implementation are set out in the river basin management plan. A review of the implementation of these measures and a summary of any additional measures shall be included in updates of the river basin management plan.
5. Member States may aim to achieve less stringent environmental objectives than those required under paragraph 1 for specific bodies of water when they are so affected by human activity, as determined in accordance with Article 5(1), or their natural condition is such that the achievement of these objectives would be infeasible or disproportionately expensive, and all the following conditions are met:
(a) the environmental and socioeconomic needs served by such human activity cannot be achieved by other means, which are a significantly better environmental option not entailing disproportionate costs;
(b) Member States ensure,
- for surface water, the highest ecological and chemical status possible is achieved, given impacts that could not reasonably have been avoided due to the nature of the human activity or pollution,
- for groundwater, the least possible changes to good groundwater status, given impacts that could not reasonably have been avoided due to the nature of the human activity or pollution;
(c) no further deterioration occurs in the status of the affected body of water;
(d) the establishment of less stringent environmental objectives, and the reasons for it, are specifically mentioned in the river basin management plan required under Article 13 and those objectives are reviewed every six years.
6. Temporary deterioration in the status of bodies of water shall not be in breach of the requirements of this Directive if this is the result of circumstances of natural cause or force majeure which are exceptional or could not reasonably have been foreseen, in particular extreme floods and prolonged droughts, or the result of circumstances due to accidents which could not reasonably have been foreseen, when all of the following conditions have been met:
(a) all practicable steps are taken to prevent further deterioration in status and in order not to compromise the achievement of the objectives of this Directive in other bodies of water not affected by those circumstances;
(b) the conditions under which circumstances that are exceptional or that could not reasonably have been foreseen may be declared, including the adoption of the appropriate indicators, are stated in the river basin management plan;
(c) the measures to be taken under such exceptional circumstances are included in the programme of measures and will not compromise the recovery of the quality of the body of water once the circumstances are over;
(d) the effects of the circumstances that are exceptional or that could not reasonably have been foreseen are reviewed annually and, subject to the reasons set out in paragraph 4(a), all practicable measures are taken with the aim of restoring the body of water to its status prior to the effects of those circumstances as soon as reasonably practicable, and
(e) a summary of the effects of the circumstances and of such measures taken or to be taken in accordance with paragraphs (a) and (d) are included in the next update of the river basin management plan.
7. Member States will not be in breach of this Directive when:
- failure to achieve good groundwater status, good ecological status or, where relevant, good ecological potential or to prevent deterioration in the status of a body of surface water or groundwater is the result of new modifications to the physical characteristics of a surface water body or alterations to the level of bodies of groundwater, or
- failure to prevent deterioration from high status to good status of a body of surface water is the result of new sustainable human development activities
and all the following conditions are met:
(a) all practicable steps are taken to mitigate the adverse impact on the status of the body of water;
(b) the reasons for those modifications or alterations are specifically set out and explained in the river basin management plan required under Article 13 and the objectives are reviewed every six years;
(c) the reasons for those modifications or alterations are of overriding public interest and/or the benefits to the environment and to society of achieving the objectives set out in paragraph 1 are outweighed by the benefits of the new modifications or alterations to human health, to the maintenance of human safety or to sustainable development, and
(d) the beneficial objectives served by those modifications or alterations of the water body cannot for reasons of technical feasibility or disproportionate cost be achieved by other means, which are a significantly better environmental option.
8. When applying paragraphs 3, 4, 5, 6 and 7, a Member State shall ensure that the application does not permanently exclude or compromise the achievement of the objectives of this Directive in other bodies of water within the same river basin district and is consistent with the implementation of other Community environmental legislation.
9. Steps must be taken to ensure that the application of the new provisions, including the application of paragraphs 3, 4, 5, 6 and 7, guarantees at least the same level of protection as the existing Community legislation.
Article 5
Characteristics of the river basin district, review of the environmental impact of human activity and economic analysis of water use
1. Each Member State shall ensure that for each river basin district or for the portion of an international river basin district falling within its territory:
- an analysis of its characteristics,
- a review of the impact of human activity on the status of surface waters and on groundwater, and
- an economic analysis of water use
is undertaken according to the technical specifications set out in Annexes II and III and that it is completed at the latest four years after the date of entry into force of this Directive.
2. The analyses and reviews mentioned under paragraph 1 shall be reviewed, and if necessary updated at the latest 13 years after the date of entry into force of this Directive and every six years thereafter.
Article 6
Register of protected areas
1. Member States shall ensure the establishment of a register or registers of all areas lying within each river basin district which have been designated as requiring special protection under specific Community legislation for the protection of their surface water and groundwater or for the conservation of habitats and species directly depending on water. They shall ensure that the register is completed at the latest four years after the date of entry into force of this Directive.
2. The register or registers shall include all bodies of water identified under Article 7(1) and all protected areas covered by Annex IV.
3. For each river basin district, the register or registers of protected areas shall be kept under review and up to date.
Article 7
Waters used for the abstraction of drinking water
1. Member States shall identify, within each river basin district:
- all bodies of water used for the abstraction of water intended for human consumption providing more than 10 m3 a day as an average or serving more than 50 persons, and
- those bodies of water intended for such future use.
Member States shall monitor, in accordance with Annex V, those bodies of water which according to Annex V, provide more than 100 m3 a day as an average.
2. For each body of water identified under paragraph 1, in addition to meeting the objectives of Article 4 in accordance with the requirements of this Directive, for surface water bodies including the quality standards established at Community level under Article 16, Member States shall ensure that under the water treatment regime applied, and in accordance with Community legislation, the resulting water will meet the requirements of Directive 80/778/EEC as amended by Directive 98/83/EC.
3. Member States shall ensure the necessary protection for the bodies of water identified with the aim of avoiding deterioration in their quality in order to reduce the level of purification treatment required in the production of drinking water. Member States may establish safeguard zones for those bodies of water.
Article 8
Monitoring of surface water status, groundwater status and protected areas
1. Member States shall ensure the establishment of programmes for the monitoring of water status in order to establish a coherent and comprehensive overview of water status within each river basin district:
- for surface waters such programmes shall cover:
(i) the volume and level or rate of flow to the extent relevant for ecological and chemical status and ecological potential, and
(ii) the ecological and chemical status and ecological potential;
- for groundwaters such programmes shall cover monitoring of the chemical and quantitative status,
- for protected areas the above programmes shall be supplemented by those specifications contained in Community legislation under which the individual protected areas have been established.
2. These programmes shall be operational at the latest six years after the date of entry into force of this Directive unless otherwise specified in the legislation concerned. Such monitoring shall be in accordance with the requirements of Annex V.
3. Technical specifications and standardised methods for analysis and monitoring of water status shall be laid down in accordance with the procedure laid down in Article 21.
Article 9
Recovery of costs for water services
1. Member States shall take account of the principle of recovery of the costs of water services, including environmental and resource costs, having regard to the economic analysis conducted according to Annex III, and in accordance in particular with the polluter pays principle.
Member States shall ensure by 2010
- that water-pricing policies provide adequate incentives for users to use water resources efficiently, and thereby contribute to the environmental objectives of this Directive,
- an adequate contribution of the different water uses, disaggregated into at least industry, households and agriculture, to the recovery of the costs of water services, based on the economic analysis conducted according to Annex III and taking account of the polluter pays principle.
Member States may in so doing have regard to the social, environmental and economic effects of the recovery as well as the geographic and climatic conditions of the region or regions affected.
2. Member States shall report in the river basin management plans on the planned steps towards implementing paragraph 1 which will contribute to achieving the environmental objectives of this Directive and on the contribution made by the various water uses to the recovery of the costs of water services.
3. Nothing in this Article shall prevent the funding of particular preventive or remedial measures in order to achieve the objectives of this Directive.
4. Member States shall not be in breach of this Directive if they decide in accordance with established practices not to apply the provisions of paragraph 1, second sentence, and for that purpose the relevant provisions of paragraph 2, for a given water-use activity, where this does not compromise the purposes and the achievement of the objectives of this Directive. Member States shall report the reasons for not fully applying paragraph 1, second sentence, in the river basin management plans.
Article 10
The combined approach for point and diffuse sources
1. Member States shall ensure that all discharges referred to in paragraph 2 into surface waters are controlled according to the combined approach set out in this Article.
2. Member States shall ensure the establishment and/or implementation of:
(a) the emission controls based on best available techniques, or
(b) the relevant emission limit values, or
(c) in the case of diffuse impacts the controls including, as appropriate, best environmental practices
set out in:
- Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control(19),
- Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment(20),
- Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources(21),
- the Directives adopted pursuant to Article 16 of this Directive,
- the Directives listed in Annex IX,
- any other relevant Community legislation
at the latest 12 years after the date of entry into force of this Directive, unless otherwise specified in the legislation concerned.
3. Where a quality objective or quality standard, whether established pursuant to this Directive, in the Directives listed in Annex IX, or pursuant to any other Community legislation, requires stricter conditions than those which would result from the application of paragraph 2, more stringent emission controls shall be set accordingly.
Article 11
Programme of measures
1. Each Member State shall ensure the establishment for each river basin district, or for the part of an international river basin district within its territory, of a programme of measures, taking account of the results of the analyses required under Article 5, in order to achieve the objectives established under Article 4. Such programmes of measures may make reference to measures following from legislation adopted at national level and covering the whole of the territory of a Member State. Where appropriate, a Member State may adopt measures applicable to all river basin districts and/or the portions of international river basin districts falling within its territory.
2. Each programme of measures shall include the "basic" measures specified in paragraph 3 and, where necessary, "supplementary" measures.
3. "Basic measures" are the minimum requirements to be complied with and shall consist of:
(a) those measures required to implement Community legislation for the protection of water, including measures required under the legislation specified in Article 10 and in part A of Annex VI;
(b) measures deemed appropriate for the purposes of Article 9;
(c) measures to promote an efficient and sustainable water use in order to avoid compromising the achievement of the objectives specified in Article 4;
(d) measures to meet the requirements of Article 7, including measures to safeguard water quality in order to reduce the level of purification treatment required for the production of drinking water;
(e) controls over the abstraction of fresh surface water and groundwater, and impoundment of fresh surface water, including a register or registers of water abstractions and a requirement of prior authorisation for abstraction and impoundment. These controls shall be periodically reviewed and, where necessary, updated. Member States can exempt from these controls, abstractions or impoundments which have no significant impact on water status;
(f) controls, including a requirement for prior authorisation of artificial recharge or augmentation of groundwater bodies. The water used may be derived from any surface water or groundwater, provided that the use of the source does not compromise the achievement of the environmental objectives established for the source or the recharged or augmented body of groundwater. These controls shall be periodically reviewed and, where necessary, updated;
(g) for point source discharges liable to cause pollution, a requirement for prior regulation, such as a prohibition on the entry of pollutants into water, or for prior authorisation, or registration based on general binding rules, laying down emission controls for the pollutants concerned, including controls in accordance with Articles 10 and 16. These controls shall be periodically reviewed and, where necessary, updated;
(h) for diffuse sources liable to cause pollution, measures to prevent or control the input of pollutants. Controls may take the form of a requirement for prior regulation, such as a prohibition on the entry of pollutants into water, prior authorisation or registration based on general binding rules where such a requirement is not otherwise provided for under Community legislation. These controls shall be periodically reviewed and, where necessary, updated;
(i) for any other significant adverse impacts on the status of water identified under Article 5 and Annex II, in particular measures to ensure that the hydromorphological conditions of the bodies of water are consistent with the achievement of the required ecological status or good ecological potential for bodies of water designated as artificial or heavily modified. Controls for this purpose may take the form of a requirement for prior authorisation or registration based on general binding rules where such a requirement is not otherwise provided for under Community legislation. Such controls shall be periodically reviewed and, where necessary, updated;
(j) a prohibition of direct discharges of pollutants into groundwater subject to the following provisions:
Member States may authorise reinjection into the same aquifer of water used for geothermal purposes.
They may also authorise, specifying the conditions for:
- injection of water containing substances resulting from the operations for exploration and extraction of hydrocarbons or mining activities, and injection of water for technical reasons, into geological formations from which hydrocarbons or other substances have been extracted or into geological formations which for natural reasons are permanently unsuitable for other purposes. Such injections shall not contain substances other than those resulting from the above operations,
- reinjection of pumped groundwater from mines and quarries or associated with the construction or maintenance of civil engineering works,
- injection of natural gas or liquefied petroleum gas (LPG) for storage purposes into geological formations which for natural reasons are permanently unsuitable for other purposes,
- injection of natural gas or liquefied petroleum gas (LPG) for storage purposes into other geological formations where there is an overriding need for security of gas supply, and where the injection is such as to prevent any present or future danger of deterioration in the quality of any receiving groundwater,
- construction, civil engineering and building works and similar activities on, or in the ground which come into contact with groundwater. For these purposes, Member States may determine that such activities are to be treated as having been authorised provided that they are conducted in accordance with general binding rules developed by the Member State in respect of such activities,
- discharges of small quantities of substances for scientific purposes for characterisation, protection or remediation of water bodies limited to the amount strictly necessary for the purposes concerned
provided such discharges do not compromise the achievement of the environmental objectives established for that body of groundwater;
(k) in accordance with action taken pursuant to Article 16, measures to eliminate pollution of surface waters by those substances specified in the list of priority substances agreed pursuant to Article 16(2) and to progressively reduce pollution by other substances which would otherwise prevent Member States from achieving the objectives for the bodies of surface waters as set out in Article 4;
(l) any measures required to prevent significant losses of pollutants from technical installations, and to prevent and/or to reduce the impact of accidental pollution incidents for example as a result of floods, including through systems to detect or give warning of such events including, in the case of accidents which could not reasonably have been foreseen, all appropriate measures to reduce the risk to aquatic ecosystems.
4. "Supplementary" measures are those measures designed and implemented in addition to the basic measures, with the aim of achieving the objectives established pursuant to Article 4. Part B of Annex VI contains a non-exclusive list of such measures.
Member States may also adopt further supplementary measures in order to provide for additional protection or improvement of the waters covered by this Directive, including in implementation of the relevant international agreements referred to in Article 1.
5. Where monitoring or other data indicate that the objectives set under Article 4 for the body of water are unlikely to be achieved, the Member State shall ensure that:
- the causes of the possible failure are investigated,
- relevant permits and authorisations are examined and reviewed as appropriate,
- the monitoring programmes are reviewed and adjusted as appropriate, and
- additional measures as may be necessary in order to achieve those objectives are established, including, as appropriate, the establishment of stricter environmental quality standards following the procedures laid down in Annex V.
Where those causes are the result of circumstances of natural cause or force majeure which are exceptional and could not reasonably have been foreseen, in particular extreme floods and prolonged droughts, the Member State may determine that additional measures are not practicable, subject to Article 4(6).
6. In implementing measures pursuant to paragraph 3, Member States shall take all appropriate steps not to increase pollution of marine waters. Without prejudice to existing legislation, the application of measures taken pursuant to paragraph 3 may on no account lead, either directly or indirectly to increased pollution of surface waters. This requirement shall not apply where it would result in increased pollution of the environment as a whole.
7. The programmes of measures shall be established at the latest nine years after the date of entry into force of this Directive and all the measures shall be made operational at the latest 12 years after that date.
8. The programmes of measures shall be reviewed, and if necessary updated at the latest 15 years after the date of entry into force of this Directive and every six years thereafter. Any new or revised measures established under an updated programme shall be made operational within three years of their establishment.
Article 12
Issues which can not be dealt with at Member State level
1. Where a Member State identifies an issue which has an impact on the management of its water but cannot be resolved by that Member State, it may report the issue to the Commission and any other Member State concerned and may make recommendations for the resolution of it.
2. The Commission shall respond to any report or recommendations from Member States within a period of six months.
Article 13
River basin management plans
1. Member States shall ensure that a river basin management plan is produced for each river basin district lying entirely within their territory.
2. In the case of an international river basin district falling entirely within the Community, Member States shall ensure coordination with the aim of producing a single international river basin management plan. Where such an international river basin management plan is not produced, Member States shall produce river basin management plans covering at least those parts of the international river basin district falling within their territory to achieve the objectives of this Directive.
3. In the case of an international river basin district extending beyond the boundaries of the Community, Member States shall endeavour to produce a single river basin management plan, and, where this is not possible, the plan shall at least cover the portion of the international river basin district lying within the territory of the Member State concerned.
4. The river basin management plan shall include the information detailed in Annex VII.
5. River basin management plans may be supplemented by the production of more detailed programmes and management plans for sub-basin, sector, issue, or water type, to deal with particular aspects of water management. Implementation of these measures shall not exempt Member States from any of their obligations under the rest of this Directive.
6. River basin management plans shall be published at the latest nine years after the date of entry into force of this Directive.
7. River basin management plans shall be reviewed and updated at the latest 15 years after the date of entry into force of this Directive and every six years thereafter.
Article 14
Public information and consultation
1. Member States shall encourage the active involvement of all interested parties in the implementation of this Directive, in particular in the production, review and updating of the river basin management plans. Member States shall ensure that, for each river basin district, they publish and make available for comments to the public, including users:
(a) a timetable and work programme for the production of the plan, including a statement of the consultation measures to be taken, at least three years before the beginning of the period to which the plan refers;
(b) an interim overview of the significant water management issues identified in the river basin, at least two years before the beginning of the period to which the plan refers;
(c) draft copies of the river basin management plan, at least one year before the beginning of the period to which the plan refers.
On request, access shall be given to background documents and information used for the development of the draft river basin management plan.
2. Member States shall allow at least six months to comment in writing on those documents in order to allow active involvement and consultation.
3. Paragraphs 1 and 2 shall apply equally to updated river basin management plans.
Article 15
Reporting
1. Member States shall send copies of the river basin management plans and all subsequent updates to the Commission and to any other Member State concerned within three months of their publication:
(a) for river basin districts falling entirely within the territory of a Member State, all river management plans covering that national territory and published pursuant to Article 13;
(b) for international river basin districts, at least the part of the river basin management plans covering the territory of the Member State.
2. Member States shall submit summary reports of:
- the analyses required under Article 5, and
- the monitoring programmes designed under Article 8
undertaken for the purposes of the first river basin management plan within three months of their completion.
3. Member States shall, within three years of the publication of each river basin management plan or update under Article 13, submit an interim report describing progress in the implementation of the planned programme of measures.
Article 16
Strategies against pollution of water
1. The European Parliament and the Council shall adopt specific measures against pollution of water by individual pollutants or groups of pollutants presenting a significant risk to or via the aquatic environment, including such risks to waters used for the abstraction of drinking water. For those pollutants measures shall be aimed at the progressive reduction and, for priority hazardous substances, as defined in Article 2(30), at the cessation or phasing-out of discharges, emissions and losses. Such measures shall be adopted acting on the proposals presented by the Commission in accordance with the procedures laid down in the Treaty.
2. The Commission shall submit a proposal setting out a list of priority substances selected amongst those which present a significant risk to or via the aquatic environment. Substances shall be prioritised for action on the basis of risk to or via the aquatic environment, identified by:
(a) risk assessment carried out under Council Regulation (EEC) No 793/93(22), Council Directive 91/414/EEC(23), and Directive 98/8/EC of the European Parliament and of the Council(24), or
(b) targeted risk-based assessment (following the methodology of Regulation (EEC) No 793/93) focusing solely on aquatic ecotoxicity and on human toxicity via the aquatic environment.
When necessary in order to meet the timetable laid down in paragraph 4, substances shall be prioritised for action on the basis of risk to, or via the aquatic environment, identified by a simplified risk-based assessment procedure based on scientific principles taking particular account of:
- evidence regarding the intrinsic hazard of the substance concerned, and in particular its aquatic ecotoxicity and human toxicity via aquatic exposure routes, and
- evidence from monitoring of widespread environmental contamination, and
- other proven factors which may indicate the possibility of widespread environmental contamination, such as production or use volume of the substance concerned, and use patterns.
3. The Commission's proposal shall also identify the priority hazardous substances. In doing so, the Commission shall take into account the selection of substances of concern undertaken in the relevant Community legislation regarding hazardous substances or relevant international agreements.
4. The Commission shall review the adopted list of priority substances at the latest four years after the date of entry into force of this Directive and at least every four years thereafter, and come forward with proposals as appropriate.
5. In preparing its proposal, the Commission shall take account of recommendations from the Scientific Committee on Toxicity, Ecotoxicity and the Environment, Member States, the European Parliament, the European Environment Agency, Community research programmes, international organisations to which the Community is a party, European business organisations including those representing small and medium-sized enterprises, European environmental organisations, and of other relevant information which comes to its attention.
6. For the priority substances, the Commission shall submit proposals of controls for:
- the progressive reduction of discharges, emissions and losses of the substances concerned, and, in particular
- the cessation or phasing-out of discharges, emissions and losses of the substances as identified in accordance with paragraph 3, including an appropriate timetable for doing so. The timetable shall not exceed 20 years after the adoption of these proposals by the European Parliament and the Council in accordance with the provisions of this Article.
In doing so it shall identify the appropriate cost-effective and proportionate level and combination of product and process controls for both point and diffuse sources and take account of Community-wide uniform emission limit values for process controls. Where appropriate, action at Community level for process controls may be established on a sector-by-sector basis. Where product controls include a review of the relevant authorisations issued under Directive 91/414/EEC and Directive 98/8/EC, such reviews shall be carried out in accordance with the provisions of those Directives. Each proposal for controls shall specify arrangements for their review, updating and for assessment of their effectiveness.
7. The Commission shall submit proposals for quality standards applicable to the concentrations of the priority substances in surface water, sediments or biota.
8. The Commission shall submit proposals, in accordance with paragraphs 6 and 7, and at least for emission controls for point sources and environmental quality standards within two years of the inclusion of the substance concerned on the list of priority substances. For substances included in the first list of priority substances, in the absence of agreement at Community level six years after the date of entry into force of this Directive, Member States shall establish environmental quality standards for these substances for all surface waters affected by discharges of those substances, and controls on the principal sources of such discharges, based, inter alia, on consideration of all technical reduction options. For substances subsequently included in the list of priority substances, in the absence of agreement at Community level, Member States shall take such action five years after the date of inclusion in the list.
9. The Commission may prepare strategies against pollution of water by any other pollutants or groups of pollutants, including any pollution which occurs as a result of accidents.
10. In preparing its proposals under paragraphs 6 and 7, the Commission shall also review all the Directives listed in Annex IX. It shall propose, by the deadline in paragraph 8, a revision of the controls in Annex IX for all those substances which are included in the list of priority substances and shall propose the appropriate measures including the possible repeal of the controls under Annex IX for all other substances.
All the controls in Annex IX for which revisions are proposed shall be repealed by the date of entry into force of those revisions.
11. The list of priority substances of substances mentioned in paragraphs 2 and 3 proposed by the Commission shall, on its adoption by the European Parliament and the Council, become Annex X to this Directive. Its revision mentioned in paragraph 4 shall follow the same procedure.
Article 17
Strategies to prevent and control pollution of groundwater
1. The European Parliament and the Council shall adopt specific measures to prevent and control groundwater pollution. Such measures shall be aimed at achieving the objective of good groundwater chemical status in accordance with Article 4(1)(b) and shall be adopted, acting on the proposal presented within two years after the entry into force of this Directive, by the Commission in accordance with the procedures laid down in the Treaty.
2. In proposing measures the Commission shall have regard to the analysis carried out according to Article 5 and Annex II. Such measures shall be proposed earlier if data are available and shall include:
(a) criteria for assessing good groundwater chemical status, in accordance with Annex II.2.2 and Annex V 2.3.2 and 2.4.5;
(b) criteria for the identification of significant and sustained upward trends and for the definition of starting points for trend reversals to be used in accordance with Annex V 2.4.4.
3. Measures resulting from the application of paragraph 1 shall be included in the programmes of measures required under Article 11.
4. In the absence of criteria adopted under paragraph 2 at Community level, Member States shall establish appropriate criteria at the latest five years after the date of entry into force of this Directive.
5. In the absence of criteria adopted under paragraph 4 at national level, trend reversal shall take as its starting point a maximum of 75 % of the level of the quality standards set out in existing Community legislation applicable to groundwater.
Article 18
Commission report
1. The Commission shall publish a report on the implementation of this Directive at the latest 12 years after the date of entry into force of this Directive and every six years thereafter, and shall submit it to the European Parliament and to the Council.
2. The report shall include the following:
(a) a review of progress in the implementation of the Directive;
(b) a review of the status of surface water and groundwater in the Community undertaken in coordination with the European Environment Agency;
(c) a survey of the river basin management plans submitted in accordance with Article 15, including suggestions for the improvement of future plans;
(d) a summary of the response to each of the reports or recommendations to the Commission made by Member States pursuant to Article 12;
(e) a summary of any proposals, control measures and strategies developed under Article 16;
(f) a summary of the responses to comments made by the European Parliament and the Council on previous implementation reports.
3. The Commission shall also publish a report on progress in implementation based on the summary reports that Member States submit under Article 15(2), and submit it to the European Parliament and the Member States, at the latest two years after the dates referred to in Articles 5 and 8.
4. The Commission shall, within three years of the publication of each report under paragraph 1, publish an interim report describing progress in implementation on the basis of the interim reports of the Member States as mentioned in Article 15(3). This shall be submitted to the European Parliament and to the Council.
5. The Commission shall convene when appropriate, in line with the reporting cycle, a conference of interested parties on Community water policy from each of the Member States, to comment on the Commission's implementation reports and to share experiences.
Participants should include representatives from the competent authorities, the European Parliament, NGOs, the social and economic partners, consumer bodies, academics and other experts.
Article 19
Plans for future Community measures
1. Once a year, the Commission shall for information purposes present to the Committee referred to in Article 21 an indicative plan of measures having an impact on water legislation which it intends to propose in the near future, including any emerging from the proposals, control measures and strategies developed under Article 16. The Commission shall make the first such presentation at the latest two years after the date of entry into force of this Directive.
2. The Commission will review this Directive at the latest 19 years after the date of its entry into force and will propose any necessary amendments to it.
Article 20
Technical adaptations to the Directive
1. Annexes I, III and section 1.3.6 of Annex V may be adapted to scientific and technical progress in accordance with the procedures laid down in Article 21, taking account of the periods for review and updating of the river basin management plans as referred to in Article 13. Where necessary, the Commission may adopt guidelines on the implementation of Annexes II and V in accordance with the procedures laid down in Article 21.
2. For the purpose of transmission and processing of data, including statistical and cartographic data, technical formats for the purpose of paragraph 1 may be adopted in accordance with the procedures laid down in Article 21.
Article 21
Regulatory committee
1. The Commission shall be assisted by a committee (hereinafter referred to as "the Committee").
2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The Committee shall adopt its rules of procedure.
Article 22
Repeals and transitional provisions
1. The following shall be repealed with effect from seven years after the date of entry into force of this Directive:
- Directive 75/440/EEC of 16 June 1975 concerning the quality required of surface water intended for the abstraction of drinking water in the Member States(25),
- Council Decision 77/795/EEC of 12 December 1977 establishing a common procedure for the exchange of information on the quality of surface freshwater in the Community(26),
- Council Directive 79/869/EEC of 9 October 1979 concerning the methods of measurement and frequencies of sampling and analysis of surface water intended for the abstraction of drinking waters in the Member States(27).
2. The following shall be repealed with effect from 13 years after the date of entry into force of this Directive:
- Council Directive 78/659/EEC of 18 July 1978 on the quality of freshwaters needing protection or improvement in order to support fish life(28),
- Council Directive 79/923/EEC of 30 October 1979 on the quality required of shellfish waters(29),
- Council Directive 80/68/EEC of 17 December 1979 on the protection of groundwater against pollution caused by certain dangerous substances,
- Directive 76/464/EEC, with the exception of Article 6, which shall be repealed with effect from the entry into force of this Directive.
3. The following transitional provisions shall apply for Directive 76/464/EEC:
(a) the list of priority substances adopted under Article 16 of this Directive shall replace the list of substances prioritised in the Commission communication to the Council of 22 June 1982;
(b) for the purposes of Article 7 of Directive 76/464/EEC, Member States may apply the principles for the identification of pollution problems and the substances causing them, the establishment of quality standards, and the adoption of measures, laid down in this Directive.
4. The environmental objectives in Article 4 and environmental quality standards established in Annex IX and pursuant to Article 16(7), and by Member States under Annex V for substances not on the list of priority substances and under Article 16(8) in respect of priority substances for which Community standards have not been set, shall be regarded as environmental quality standards for the purposes of point 7 of Article 2 and Article 10 of Directive 96/61/EC.
5. Where a substance on the list of priority substances adopted under Article 16 is not included in Annex VIII to this Directive or in Annex III to Directive 96/61/EC, it shall be added thereto.
6. For bodies of surface water, environmental objectives established under the first river basin management plan required by this Directive shall, as a minimum, give effect to quality standards at least as stringent as those required to implement Directive 76/464/EEC.
Article 23
Penalties
Member States shall determine penalties applicable to breaches of the national provisions adopted pursuant to this Directive. The penalties thus provided for shall be effective, proportionate and dissuasive.
Article 24
Implementation
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive at the latest 22 December 2003. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof.
Article 25
Entry into force
DieThis Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 26
Addressees
This Directive is addressed to the Member States.
|
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"UKSI19861510",
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"UKSI20170407",
"UKSI20071067",
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"UKSI20021559",
"UKPGA19950025",
"UKSI20082349",
"UKSI20040641",
"UKSI20100740",
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32000L0071
|
2000
|
Commission Directive 2000/71/EC of 7 November 2000 to adapt the measuring methods as laid down in Annexes I, II, III and IV to Directive 98/70/EC of the European Parliament and of the Council to technical progress as foreseen in Article 10 of that Directive (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels and amending Council Directive 93/12/EC(1), and in particular Article 10 thereof,
Whereas:
(1) Directive 98/70/EC establishes environmental specifications for unleaded petrol and diesel fuels. Annex I to IV to that Directive include the test methods and their dates of publication which shall be used to determine quality of petrol and diesel fuels in relation to these environmental specifications.
(2) European Standard 228 and European Standard 590 also establish quality specifications for petrol and diesel respectively to ensure the proper functioning of these products. These standards have recently updated and adopted by European Committee for Standardisation on 29 October 1999 and the test methods for some quality parameters which also are included as environmental specifictions in Annex I to IV of Directive 98/70/EC have been updated or changed to reflect technical progress. The test methods in Annex I to IV should be consistent with those in European Standards 228 and 590 to facilitate the implementation of the directive and to ensure that its updated to reflect technical progress.
(3) The measures provided for in this Directive are in accordance with the opinion of the Article 10 Committee established to, inter alia, assist the Commission to adapt Directive 98/70/EC to technical progress,
Article 1
Annex I to IV to Directive 98/70/EC are replaced by Annex I to IV to this Directive.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2001 at the latest. They shall forthwith inform the Commission thereof.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.
|
[
"UKSI20013896"
] |
32000L0064
|
2000
|
Directive 2000/64/EC of the European Parliament and of the Council of 7 November 2000 amending Council Directives 85/611/EEC, 92/49/EEC, 92/96/EEC and 93/22/EEC as regards exchange of information with third countries
Having regard to the Treaty establishing the European Community, and in particular the first and third sentences of Article 47(2) thereof,
Having regard to the proposal from the Commission(1),
Having regard to the Opinion of the Economic and Social Committee(2),
Acting in accordance with the procedure referred to in Article 251 of the Treaty(3),
Whereas:
(1) Council Directives 85/611/EEC(4), 92/49/EEC(5), 92/96/EEC(6) and 93/22/EEC(7) allow the exchange of information between competent authorities and with certain other authorities or bodies within a Member State or between Member States. The said Directives also allow the conclusion by Member States of cooperation agreements providing for the exchange of information with the competent authorities of third countries.
(2) On grounds of consistency with Directive 98/33/EC(8), this authorisation to conclude agreements on the exchange of information with third countries should be extended so as to include the exchange of information with certain other authorities or bodies in those countries provided that the information disclosed is subject to appropriate guarantees of professional secrecy.
(3) Directive 85/611/EEC, Directive 92/49/EEC, Directive 92/96/EEC and Directive 93/22/EEC should be amended accordingly,
Article 1
Article 50(4) of Directive 85/611/EEC shall be replaced by the following:
"4. Member States may conclude cooperation agreements providing for exchange of information with the competent authorities of third countries or with authorities or bodies of third countries as defined in paragraphs 6 and 7 only if the information disclosed is subject to guarantees of professional secrecy at least equivalent to those referred to in this Article. Such exchange of information must be intended for the performance of the supervisory task of the authorities or bodies mentioned.
Where the information originates in another Member State, it may not be disclosed without the express agreement of the competent authorities which have disclosed it and, where appropriate, solely for the purposes for which those authorities gave their agreement."
Article 2
Article 16(3) of Directive 92/49/EEC, Article 15(3) of Directive 92/96/EEC and Article 25(3) of Directive 93/22/EEC, shall be replaced by the following:
"3. Member States may conclude cooperation agreements providing for exchange of information with the competent authorities of third countries or with authorities or bodies of third countries as defined in paragraphs 5 and 5a only if the information disclosed is subject to guarantees of professional secrecy at least equivalent to those referred to in this Article. Such exchange of information must be intended for the performance of the supervisory task of the authorities or bodies mentioned.
Where the information originates in another Member State, it may not be disclosed without the express agreement of the competent authorities which have disclosed it and, where appropriate, solely for the purposes for which those authorities gave their agreement."
Article 3
1. Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive not later than 17 November 2002. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
2. Member States shall communicate to the Commission the text of the main provisions of domestic law, which they adopt in the field governed by this Directive.
Article 4
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 5
This Directive is addressed to the Member States.
|
[
"UKSI20013437"
] |
32000L0069
|
2000
|
Directive 2000/69/EC of the European Parliament and of the Council of 16 November 2000 relating to limit values for benzene and carbon monoxide in ambient air
Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the Economic and Social Committee(2),
After consultation of the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),
Whereas:
(1) On the basis of principles enshrined in Article 174 of the Treaty, the European Community programme of policy and action in relation to the environment and sustainable development (the Fifth Environment Action Programme)(4), supplemented by Decision No 2179/98/EC of the European Parliament and the Council(5) on its review, envisages in particular amendments to legislation on air pollutants. That programme recommends the establishment of long-term objectives on air quality. Article 174 of the Treaty requires the precautionary principle to be applied in relation to the protection of human health and the environment.
(2) Article 152 of the Treaty provides that health-protection requirements are to form a constituent part of the Community's other policies. Article 3(1)(p) of the Treaty provides that the activities of the Community are to include a contribution to the attainment of a high level of health protection.
(3) Pursuant to Article 4(5) of Council Directive 96/62/EC of 27 September 1996 on ambient air quality assessment and management(6), the Council is to adopt the legislation provided for in paragraph 1 as well as the provisions laid down in paragraphs 3 and 4 of that Article.
(4) Directive 96/62/EC requires that action plans be developed for zones within which concentrations of pollutants in ambient air exceed limit values, plus any temporary margins of tolerance applicable in order to ensure compliance with limit values by the dates laid down.
(5) Directive 96/62/EC provides that the numerical values for limit values are to be based on the findings of work carried out by international scientific groups active in the field. The Commission is to take account of the most recent scientific research data in the epidemiological and environmental fields concerned and of the most recent advances in metrology for re-examining the elements on which limit values are based.
(6) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(7).
(7) The amendments necessary for adaptation to scientific and technical progress may relate solely to criteria and techniques for the assessment of concentrations of benzene and carbon monoxide or detailed arrangements for forwarding information to the Commission, and may not have the effect of modifying limit values either directly or indirectly.
(8) The limit values laid down in this Directive are minimum requirements; in accordance with Article 176 of the Treaty, Member States may maintain or introduce more stringent protective measures; in particular, stricter limit values may be introduced to protect the health of particularly vulnerable categories of the population, such as children and hospital patients. A Member State may require that limit values be attained before the dates laid down in this Directive.
(9) Benzene is a human genotoxic carcinogen and there is no identifiable threshold below which there is no risk to human health.
(10) However, when limit values for benzene as set by this Directive are difficult to achieve because of site-specific dispersion characteristics or relevant climatic conditions and if the application of the measures would result in severe socio-economic problems, Member States may ask the Commission for one time-limited extension under specific conditions.
(11) In order to facilitate the review of this Directive in 2004, the Commission and the Member States should consider encouraging research into the effects of benzene and carbon monoxide, taking air pollution in enclosed spaces into account as well as that in outside air.
(12) Standardised accurate measurement techniques and common criteria for the location of measuring stations are an important element in the assessment of ambient air quality with a view to obtaining comparable information across the Community.
(13) Information on concentrations of benzene and carbon monoxide should be forwarded to the Commission as a basis for regular reports.
(14) Up-to-date information on concentrations of benzene and carbon monoxide in ambient air should be readily available to the public,
Article 1
Objectives
The objectives of this Directive shall be:
(a) to establish limit values for concentrations of benzene and carbon monoxide in ambient air intended to avoid, prevent or reduce harmful effects on human health and the environment as a whole;
(b) to assess concentrations of benzene and carbon monoxide in ambient air on the basis of common methods and criteria;
(c) to obtain adequate information on concentrations of benzene and carbon monoxide in ambient air and ensure that it is made available to the public;
(d) to maintain ambient air quality where it is good and improve it in other cases with respect to benzene and carbon monoxide.
Article 2
Definitions
The definitions in Article 2 of Directive 96/62/EC shall apply.
For the purposes of this Directive:
(a) "upper assessment threshold" shall mean a level specified in Annex III, below which a combination of measurements and modelling techniques may be used to assess ambient air quality, in accordance with Article 6(3) of Directive 96/62/EC;
(b) "lower assessment threshold" shall mean a level specified in Annex III, below which modelling or objective estimation techniques alone may be used to assess ambient air quality in accordance with Article 6(4) of Directive 96/62/EC;
(c) "fixed measurements" shall mean measurements taken in accordance with Article 6(5) of Directive 96/62/EC.
Article 3
Benzene
1. Member States shall take the measures necessary to ensure that concentrations of benzene in ambient air, as assessed in accordance with Article 5, do not exceed the limit value laid down in Annex I according to the dates mentioned therein.
The margin of tolerance laid down in Annex I shall apply in accordance with Article 8 of Directive 96/62/EC.
2. When the limit value laid down in Annex I is difficult to achieve because of site-specific dispersion characteristics or relevant climatic conditions, such as low windspeed and/or conditions conducive to evaporation, and if the application of the measures were to result in severe socio-economic problems, a Member State may ask the Commission for a time-limited extension. The Commission, acting in accordance with the procedure laid down in Article 12(2) of Directive 96/62/EC, may, at the request of a Member State and without prejudice to Article 8(3) of this Directive, grant one extension for a period of up to five years if the Member State concerned:
- designates the zones and/or agglomerations concerned;
- provides the necessary justification for such an extension;
- demonstrates that all reasonable measures have been taken to lower the concentrations of the pollutants concerned and to minimise the area over which the limit value is exceeded, and
- outlines the future developments with regard to the measures which it will take according to Article 8(3) of Directive 96/62/EC.
The limit value for benzene to be granted during that time-limited extension shall, however, not exceed 10 μg/m3.
Article 4
Carbon monoxide
Member States shall take the measures necessary to ensure that concentrations of carbon monoxide in ambient air, as assessed in accordance with Article 5, do not exceed the limit value laid down in Annex II according to the dates mentioned therein.
The margin of tolerance laid down in Annex II shall apply in accordance with Article 8 of Directive 96/62/EC.
Article 5
Assessment of concentrations
1. The upper and lower assessment thresholds for benzene and carbon monoxide shall be those laid down in Section I of Annex III.
The classification of each zone or agglomeration for the purposes of Article 6 of Directive 96/62/EEC shall be reviewed at least every five years in accordance with the procedure laid down in Section II of Annex III to this Directive. Classification shall be reviewed earlier in the event of significant change in activities relevant to ambient concentrations of benzene or carbon monoxide.
2. The criteria for determining the location of sampling points for the measurement of benzene and carbon monoxide in ambient air shall be those listed in Annex IV. The minimum number of sampling points for fixed measurements of concentrations of each relevant pollutant shall be as laid down in Annex V, and they shall be installed in each zone or agglomeration within which measurement is required if fixed measurement is the sole source of data on concentrations within it.
3. For zones and agglomerations within which information from fixed measurement stations is supplemented by information from other sources, such as emission inventories, indicative measurement methods and air quality modelling, the number of fixed measuring stations to be installed and the spatial resolution of other techniques shall be sufficient for the concentrations of air pollutants to be established in accordance with Section I of Annex IV, and Section I of Annex VI.
4. For zones and agglomerations within which measurement is not required, modelling or objective-estimation techniques may be used.
5. The reference methods for the analysis and the sampling of benzene and carbon monoxide shall be as laid down in Sections I and II of Annex VII. Section III of Annex VII will set out reference techniques for air quality modelling when such techniques are available.
6. The date by which Member States shall inform the Commission of the methods used for the preliminary assessment of air quality under point (d) of Article 11(1) of Directive 96/62/EC shall be the date set out in Article 10 of this Directive.
7. Any amendments necessary to adapt the provisions of this Article and Annexes III to VII to scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 6(2) but may not result in any direct or indirect changes to limit values.
Article 6
Committee
1. The Commission shall be assisted by the committee referred to in Article 12(2) of Directive 96/62/EC, hereinafter referred to as "the Committee".
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The Committee shall adopt its rules of procedure.
Article 7
Public information
1. Member States shall ensure that up-to-date information on ambient concentrations of benzene and carbon monoxide is routinely made available to the public as well as to appropriate organisations, such as environmental organisations, consumer organisations, organisations representing the interests of sensitive populations and other relevant health-care bodies, by means, for example, of broadcast media, press, information screens or computer-network services, teletext, telephone or fax.
Information on ambient concentrations of benzene, as an average value over the last 12 months, shall be updated on at least a three-monthly basis and, wherever practicable, information shall be updated on a monthly basis. Information on ambient concentrations of carbon monoxide, as a maximum running average over eight hours, shall be updated on at least a daily basis and, wherever practicable, information shall be updated on an hourly basis.
The information referred to in the second subparagraph shall at least indicate any exceedances of the concentrations stated in the limit values over the averaging periods laid down in Annexes I and II. It shall also provide a short assessment in relation to limit values and appropriate information regarding effects on health.
2. When making plans or programmes available to the public under Article 8(3) of Directive 96/62/EC, Member States shall also make them available to the organisations referred to in paragraph 1 of this Article. This also includes the documentation required by Annex VI(II) of this Directive.
3. Information made available to the public and to organisations under paragraphs 1 and 2 shall be clear, comprehensible and accessible.
Article 8
Report and review
1. No later than 31 December 2004 the Commission shall submit to the European Parliament and the Council a report based on the experience acquired in the application of this Directive and, in particular, on the results of the most recent scientific research concerning the effects on human health, paying particular attention to sensitive populations, and on ecosystems of exposure to benzene and carbon monoxide, and on technological developments including the progress achieved in methods of measuring and otherwise assessing concentrations of benzene and carbon monoxide in ambient air.
2. The report referred to in paragraph 1 shall take into account in particular as regards benzene and carbon monoxide:
(a) current air quality and trends up to and beyond the year 2010;
(b) the scope for making further reductions to polluting emissions across all relevant sources, taking account of their technical feasibility and cost-effectiveness;
(c) the relationships between pollutants and opportunities for combined strategies for achieving Community air quality and related objectives;
(d) current and future requirements for informing the public and for the exchange of information between Member States and Commission;
(e) the experience acquired in the application of this Directive in Member States including, in particular, the conditions laid down in Annex IV under which measurement has been carried out.
3. With a view to maintaining a high level of protection of human health and the environment, the report referred to in paragraph 1 shall be accompanied, if appropriate, by proposals for the amendment of this Directive which could include further extensions to the timetable for meeting the limit value for benzene in Annex I which may be agreed under Article 3(2).
Article 9
Penalties
Member States shall determine the penalties applicable to breaches of the national provisions adopted pursuant to this Directive. The penalties shall be effective, proportionate and dissuasive.
Article 10
Implementation
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 13 December 2002 at the latest. They shall forthwith inform the Commission thereof.
When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 11
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 12
Addressees
This Directive is addressed to the Member States.
|
[
"UKSI20023117"
] |
32000L0059
|
2000
|
Directive 2000/59/EC of the European Parliament and of the Council of 27 November 2000 on port reception facilities for ship-generated waste and cargo residues - Commission declaration
Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof,
Having regard to the proposal from the Commission(1),
Having regard to the Opinion of the Economic and Social Committee(2),
Having regard to the Opinion of the Committee of the Regions(3),
Acting in accordance with the procedure referred to in Article 251 of the Treaty(4), and in the light of the joint text approved by the Conciliation Committee on 18 July 2000,
Whereas:
(1) Community policy on the environment aims at a high level of protection. It is based on the precautionary principle and the principles that the polluter should pay and that preventive action should be taken.
(2) One important field of Community action in maritime transport concerns the reduction of the pollution of the seas. This can be achieved through compliance with international conventions, codes and resolutions while maintaining the freedom of navigation as provided for by the United Nations Convention on the Law of the Sea and the freedom of providing services as provided for in Community law.
(3) The Community is seriously concerned about the pollution of the seas and coastlines of the Member States caused by discharges of waste and cargo residues from ships, and in particular about the implementation of the International Convention for the Prevention of Pollution from Ships, 1973, as modified by the Protocol of 1978 relating thereto (Marpol 73/78) which regulates what wastes can be discharged from ships into the marine environment and requires States Parties to ensure the provision of adequate reception facilities in ports. All Member States have ratified Marpol 73/78.
(4) The protection of the marine environment can be enhanced by reducing discharges into the sea of ship-generated waste and cargo residues. This can be achieved by improving the availability and use of reception facilities and by improving the enforcement regime. In its Resolution of 8 June 1993 on a common policy on safe seas(5), the Council included among its priority actions the development of availability and use of reception facilities within the Community.
(5) Council Directive 95/21/EC of 19 June 1995 concerning the enforcement, in respect of shipping using Community ports and sailing in the waters under the jurisdiction of the Member States, of international standards for ship safety, pollution prevention and shipboard living and working conditions (port State control)(6) provides that ships posing an unreasonable threat of harm to the marine environment may not proceed to sea.
(6) Pollution of the seas by its very nature has transboundary implications. In view of the subsidiarity principle, action at Community level is the most effective way of ensuring common environmental standards for ships and ports throughout the Community.
(7) In view of the proportionality principle, a Directive is the appropriate legal instrument, as it provides a framework for the Member States' uniform and compulsory application of environmental standards, while leaving each Member State the right to decide which implementation tools best fit its internal system.
(8) Consistency with existing regional agreements, such as the 1974/1992 Convention on the Protection of the Marine Environment in the Baltic Sea Area, should be ensured.
(9) In the interest of improving pollution prevention and avoiding distortion of competition, the environmental requirements should apply to all ships, irrespective of the flag they fly, and adequate reception facilities should be made available in all ports of the Community.
(10) Adequate port reception facilities should meet the needs of users, from the largest merchant ship to the smallest recreational craft, and of the environment, without causing undue delay to the ships using them. The obligation to ensure the availability of adequate port reception facilities leaves the Member States with a high degree of freedom to arrange the reception of waste in the most suitable manner and permits them, inter alia, to provide fixed reception installations or to appoint service providers bringing to the ports mobile units for the reception of waste when needed. This obligation also implies the obligation to provide all services and/or other accompanying arrangements necessary for the proper and adequate use of these facilities.
(11) Adequacy of facilities can be improved by up-to-date waste reception and handling plans established in consultation with the relevant parties.
(12) The effectiveness of port reception facilities can be improved by requiring ships to notify their need to use reception facilities. Such notification would also provide information for effectively planned waste management. Waste from fishing vessels and from recreational craft authorised to carry no more than 12 passengers may be handled by the port reception facilities without prior notification.
(13) Discharges of ship-generated waste at sea can be reduced by requiring all ships to deliver their waste to port reception facilities before leaving the port. In order to reconcile the interest of the smooth operation of maritime transport with the protection of the environment, exceptions to this requirement should be possible taking into account the sufficiency of the dedicated storage capacity on board, the possibility to deliver at another port without risk of discharge at sea and specific delivery requirements adopted in accordance with international law.
(14) In view of the "polluter pays" principle, the costs of port reception facilities, including the treatment and disposal of ship-generated waste, should be covered by ships. In the interest of protecting the environment, the fee system should encourage the delivery of ship-generated waste to ports instead of discharge into the sea. This can be facilitated by providing that all ships contribute to the costs for the reception and handling of ship-generated waste so as to reduce the economic incentives to discharge into the sea. In view of the subsidiarity principle, Member States should, in accordance with their national laws and current practices, retain the powers to establish whether and in what proportion the fees related to quantities actually delivered by the ships will be included in the cost recovery systems for using port reception facilities. Charges for using these facilities should be fair, non-discriminatory and transparent.
(15) Ships producing reduced quantities of ship-generated waste should be treated more favourably in the cost recovery systems. Common criteria would facilitate the identification of such ships.
(16) In order to avoid undue burden for the parties concerned, ships engaged in scheduled traffic with frequent and regular port calls may be exempted from certain obligations deriving from this Directive where there is sufficient evidence that there are arrangements to ensure the delivery of the waste and the payment of fees.
(17) Cargo residues should be delivered to port reception facilities in accordance with Marpol 73/78. Marpol 73/78 requires cargo residues to be delivered to port reception facilities to the extent necessary to comply with the tank cleaning requirements. Any fee for such delivery should be paid by the user of the reception facility, the user being normally specified in the contractual arrangements between the parties involved or in other local arrangements.
(18) It is necessary to undertake targeted inspections in order to verify compliance with this Directive. The number of such inspections, as well as the penalties imposed, should be sufficient to deter non-compliance with this Directive. For reasons of efficiency and cost-effectiveness, such inspections may be undertaken within the framework of Directive 95/21/EC, when applicable.
(19) Member States should ensure a proper administrative framework for the adequate functioning of the port reception facilities. Under Marpol 73/78, allegations of inadequate port reception facilities should be transmitted to the International Maritime Organisation (IMO). The same information could be simultaneously transmitted to the Commission for information purposes.
(20) An information system for the identification of polluting or potentially polluting ships would facilitate the enforcement of this Directive and would be helpful in evaluating the implementation thereof. The SIRENAC information system established under the Paris Memorandum of Understanding on Port State Control provides a large amount of the additional information needed for that purpose.
(21) It is necessary that a Committee consisting of representatives of the Member States assist the Commission in the effective application of this Directive. Since the measures necessary for implementing this Directive are measures of a general scope within the meaning of Article 2 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(7), such measures should be adopted in accordance with the regulatory procedure provided for in Article 5 of that Decision.
(22) Certain provisions of this Directive may, without broadening its scope, be amended in accordance with that procedure in order to take into account Community or IMO measures which enter into force in the future so as to ensure their harmonised implementation,
Article 1
Purpose
The purpose of this Directive is to reduce the discharges of ship-generated waste and cargo residues into the sea, especially illegal discharges, from ships using ports in the Community, by improving the availability and use of port reception facilities for ship-generated waste and cargo residues, thereby enhancing the protection of the marine environment.
Article 2
Definitions
For the purpose of this Directive:
(a) "ship" shall mean a seagoing vessel of any type whatsoever operating in the marine environment and shall include hydrofoil boats, air-cushion vehicles, submersibles and floating craft;
(b) "Marpol 73/78" shall mean the International Convention for the Prevention of Pollution from Ships, 1973, as modified by the Protocol of 1978 relating thereto, as in force at the date of adoption of this Directive;
(c) "ship-generated waste" shall mean all waste, including sewage, and residues other than cargo residues, which are generated during the service of a ship and fall under the scope of Annexes I, IV and V to Marpol 73/78 and cargo-associated waste as defined in the Guidelines for the implementation of Annex V to Marpol 73/78;
(d) "cargo residues" shall mean the remnants of any cargo material on board in cargo holds or tanks which remain after unloading procedures and cleaning operations are completed and shall include loading/unloading excesses and spillage;
(e) "port reception facilities" shall mean any facility, which is fixed, floating or mobile and capable of receiving ship-generated waste or cargo residues;
(f) "fishing vessel" shall mean any ship equipped or used commercially for catching fish or other living resources of the sea;
(g) "recreational craft" shall mean a ship of any type, regardless of the means of propulsion, intended for sports or leisure purposes;
(h) "port" shall mean a place or a geographical area made up of such improvement works and equipment as to permit, principally, the reception of ships, including fishing vessels and recreational craft.
Without prejudice to the definitions in points (c) and (d), "ship-generated waste" and "cargo residues" shall be considered to be waste within the meaning of Article 1(a) of Council Directive 75/442/EEC of 15 July 1975 on waste(8).
Article 3
Scope
This Directive shall apply to:
(a) all ships, including fishing vessels and recreational craft, irrespective of their flag, calling at, or operating within, a port of a Member State, with the exception of any warship, naval auxiliary or other ship owned or operated by a State and used, for the time being, only on government non-commercial service; and
(b) all ports of the Member States normally visited by ships falling under the scope of point (a).
Member States shall take measures to ensure that ships which are excluded from the scope of this Directive under point (a) of the preceding paragraph deliver their ship-generated waste and cargo residues in a manner consistent, in so far as is reasonable and practicable, with this Directive.
Article 4
Port reception facilities
1. Member States shall ensure the availability of port reception facilities adequate to meet the needs of the ships normally using the port without causing undue delay to ships.
2. To achieve adequacy, the reception facilities shall be capable of receiving the types and quantities of ship-generated waste and cargo residues from ships normally using that port, taking into account the operational needs of the users of the port, the size and the geographical location of the port, the type of ships calling at that port and the exemptions provided for under Article 9.
3. Member States shall establish procedures, in accordance with those agreed by the International Maritime Organization (IMO), for reporting to the port State alleged inadequacies of port reception facilities.
Article 5
Waste reception and handling plans
1. An appropriate waste reception and handling plan shall be developed and implemented for each port following consultations with the relevant parties, in particular with port users or their representatives, having regard to the requirements of Articles 4, 6, 7, 10 and 12. Detailed requirements for the development of such plans are set out in Annex I.
2. The waste reception and handling plans referred to in paragraph 1 may, where required for reasons of efficiency, be developed in a regional context with the appropriate involvement of each port, provided that the need for, and availability of, reception facilities are specified for each individual port.
3. Member States shall evaluate and approve the waste reception and handling plan, monitor its implementation and ensure its re-approval at least every three years and after significant changes in the operation of the port.
Article 6
Notification
1. The master of a ship, other than a fishing vessel or recreational craft authorised to carry no more than 12 passengers, bound for a port located in the Community shall complete truly and accurately the form in Annex II and notify that information to the authority or body designated for this purpose by the Member State in which that port is located:
(a) at least 24 hours prior to arrival, if the port of call is known; or
(b) as soon as the port of call is known, if this information is available less than 24 hours prior to arrival; or
(c) at the latest upon departure from the previous port, if the duration of the voyage is less than 24 hours.
Member States may decide that the information will be notified to the operator of the port reception facility, who will forward it to the relevant authority.
2. The information referred to in paragraph 1 shall be kept on board at least until the next port of call and shall upon request be made available to the Member States' authorities.
Article 7
Delivery of ship-generated waste
1. The master of a ship calling at a Community port shall, before leaving the port, deliver all ship-generated waste to a port reception facility.
2. Notwithstanding paragraph 1, a ship may proceed to the next port of call without delivering the ship-generated waste, if it follows from the information given in accordance with Article 6 and Annex II, that there is sufficient dedicated storage capacity for all ship-generated waste that has been accumulated and will be accumulated during the intended voyage of the ship until the port of delivery.
If there are good reasons to believe that adequate facilities are not available at the intended port of delivery, or if this port is unknown, and that there is therefore a risk that the waste will be discharged at sea, the Member State shall take all necessary measures to prevent marine pollution, if necessary by requiring the ship to deliver its waste before departure from the port.
3. Paragraph 2 shall apply without prejudice to more stringent delivery requirements for ships adopted in accordance with international law.
Article 8
Fees for ship-generated waste
1. Member States shall ensure that the costs of port reception facilities for ship-generated waste, including the treatment and disposal of the waste, shall be covered through the collection of a fee from ships.
2. The cost recovery systems for using port reception facilities shall provide no incentive for ships to discharge their waste into the sea. To this end the following principles shall apply to ships other than fishing vessels and recreational craft authorised to carry no more than 12 passengers:
(a) all ships calling at a port of a Member State shall contribute significantly to the costs referred to in paragraph 1, irrespective of actual use of the facilities. Arrangements to this effect may include incorporation of the fee in the port dues or a separate standard waste fee. The fees may be differentiated with respect to, inter alia, the category, type and size of the ship;
(b) the part of the costs which is not covered by the fee referred to in subparagraph (a), if any, shall be covered on the basis of the types and quantities of ship-generated waste actually delivered by the ship;
(c) fees may be reduced if the ship's environmental management, design, equipment and operation are such that the master of the ship can demonstrate that it produces reduced quantities of ship-generated waste.
3. In order to ensure that the fees are fair, transparent, non-discriminatory and reflect the costs of the facilities and services made available and, where appropriate, used, the amount of the fees and the basis on which they have been calculated should be made clear for the port users.
4. The Commission shall, within three years of the date referred to in Article 16(1), submit a report to the European Parliament and to the Council, evaluating the impact of the variety of cost recovery systems adopted in accordance with paragraph 2 on the marine environment and waste flow patterns. This report shall be drawn up in liaison with the competent authorities of the Member States and representatives of ports.
The Commission shall, if necessary in the light of this evaluation, submit a proposal to amend this Directive by the introduction of a system involving the payment of an appropriate percentage, of no less than one third, of the costs referred to in paragraph 1 by all ships calling at a port of a Member State irrespective of actual use of the facilities, or an alternative system with equivalent effects.
Article 9
Exemptions
1. When ships are engaged in scheduled traffic with frequent and regular port calls and there is sufficient evidence of an arrangement to ensure the delivery of ship-generated waste and payment of fees in a port along the ship's route, Member States of the ports involved may exempt these ships from the obligations in Article 6, Article 7(1) and Article 8.
2. Member States shall inform the Commission of exemptions granted in accordance with paragraph 1 on a regular basis, at least once a year.
Article 10
Delivery of cargo residues
The master of a ship calling at a Community port shall ensure that cargo residues are delivered to a port reception facility in accordance with the provisions of Marpol 73/78. Any fee for delivery of cargo residues shall be paid by the user of the reception facility.
Article 11
Enforcement
1. Member States shall ensure that any ship may be subject to an inspection in order to verify that it complies with Articles 7 and 10 and that a sufficient number of such inspections is carried out.
2. For inspections concerning ships other than fishing vessels and recreational craft authorised to carry no more than 12 passengers:
(a) in selecting ships for inspection, Member States shall pay particular attention to:
- ships which have not complied with the notification requirements in Article 6;
- ships for which the examination of the information provided by the master in accordance with Article 6 has revealed other grounds to believe that the ship does not comply with this Directive;
(b) such inspection may be undertaken within the framework of Directive 95/21/EC, when applicable; whatever the framework of the inspections, the 25 % inspection requirement set out in that Directive shall apply;
(c) if the relevant authority is not satisfied with the results of this inspection, it shall ensure that the ship does not leave the port until it has delivered its ship-generated waste and cargo residues to a port reception facility in accordance with Articles 7 and 10;
(d) when there is clear evidence that a ship has proceeded to sea without having complied with Articles 7 or 10, the competent authority of the next port of call shall be informed thereof and such a ship shall, without prejudice to the application of the penalties referred to in Article 13, not be permitted to leave that port until a more detailed assessment of factors relating to the ship's compliance with this Directive, such as the accuracy of any information provided in accordance with Article 6, has taken place.
3. Member States shall establish control procedures, to the extent required, for fishing vessels and recreational craft authorised to carry no more than 12 passengers to ensure compliance with the applicable requirements of this Directive.
Article 12
Accompanying measures
1. Member States shall:
(a) take all necessary measures to ensure that masters, providers of port reception facilities and other persons concerned are adequately informed of the requirements addressed to them under this Directive and that they comply with them;
(b) designate appropriate authorities or bodies for performing functions under this Directive;
(c) make provision for cooperation between their relevant authorities and commercial organisations to ensure the effective implementation of this Directive;
(d) ensure that the information notified by masters in accordance with Article 6 be appropriately examined;
(e) ensure that the formalities relating to the use of port reception facilities are simple and expeditious in order to create an incentive for the master to use port reception facilities and to avoid undue delays to ships;
(f) ensure that the Commission is provided with a copy of the allegations of inadequate port reception facilities referred to in Article 4(3);
(g) ensure that the treatment, recovery or disposal of ship-generated waste and cargo residues shall be carried out in accordance with Directive 75/442/EEC and other relevant Community waste legislation, in particular Council Directive 75/439/EEC of 16 June 1975 on the disposal of waste oils(9) and Council Directive 91/689/EEC of 12 December 1991 on hazardous waste(10).
(h) ensure in accordance with their national legislation that any party involved in the delivery or reception of ship-generated waste or cargo residues can claim compensation for damage caused by undue delay.
2. Delivery of ship-generated waste and cargo residues shall be considered as release for free circulation within the meaning of Article 79 of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code(11). The customs authorities shall not require the lodging of a summary declaration in accordance with Article 45 of the Community Customs Code.
3. Member States and the Commission shall co-operate in establishing an appropriate information and monitoring system, covering at least the whole of the Community, to:
- improve the identification of ships which have not delivered their ship-generated waste and cargo residues in accordance with this Directive,
- ascertain whether the goals set in Article 1 of the Directive have been met.
4. Member States and the Commission shall cooperate in establishing common criteria for identifying ships referred to in Article 8(2)(c).
Article 13
Penalties
Member States shall lay down a system of penalties for the breach of national provisions adopted pursuant to this Directive and shall take all the measures necessary to ensure that those penalties are applied. The penalties thus provided shall be effective, proportionate and dissuasive.
Article 14
Regulatory Committee
1. The Commission shall be assisted by the Committee set up pursuant to Article 12(1) of Directive 93/75/EEC(12), hereinafter referred to as "the Committee".
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The Committee shall adopt its rules of procedure.
Article 15
Amendment procedure
The Annexes to this Directive, the definition in Article 2(b), references to Community instruments and references to IMO instruments may be amended in accordance with the procedure laid down in Article 14(2) in order to bring them into line with Community or IMO measures which have entered into force, insofar as such amendments do not broaden the scope of this Directive.
Furthermore, the Annexes to this Directive may be amended in accordance with that procedure when necessary to improve the regime established by this Directive, insofar as such amendments do not broaden the scope of this Directive.
Article 16
Implementation
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 28 December 2002 and forthwith inform the Commission thereof.
However, as far as sewage as referred to in Article 2(c) is concerned, the implementation of this Directive shall be suspended until 12 months after the entry into force of Annex IV to Marpol 73/78, while respecting the distinction made in this convention between new and existing ships.
2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by Member States.
Article 17
Evaluation
1. Member States shall submit to the Commission a status report concerning the implementation of this Directive every three years.
2. The Commission shall submit an evaluation report on the operation of the system as provided for in this Directive to the European Parliament and the Council, on the basis of the reports of the Member States as provided for in paragraph 1 together with proposals as necessary, concerning the implementation of this Directive.
Article 18
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 19
Addressees
This Directive is addressed to the Member States.
|
[
"UKSI20031809",
"UKSI20091176"
] |
32000L0078
|
2000
|
Council Directive 2000/78/EC of 27 November 2000 establishing a general framework for equal treatment in employment and occupation
Having regard to the Treaty establishing the European Community, and in particular Article 13 thereof,
Having regard to the proposal from the Commission(1),
Having regard to the Opinion of the European Parliament(2),
Having regard to the Opinion of the Economic and Social Committee(3),
Having regard to the Opinion of the Committee of the Regions(4),
Whereas:
(1) In accordance with Article 6 of the Treaty on European Union, the European Union is founded on the principles of liberty, democracy, respect for human rights and fundamental freedoms, and the rule of law, principles which are common to all Member States and it respects fundamental rights, as guaranteed by the European Convention for the Protection of Human Rights and Fundamental Freedoms and as they result from the constitutional traditions common to the Member States, as general principles of Community law.
(2) The principle of equal treatment between women and men is well established by an important body of Community law, in particular in Council Directive 76/207/EEC of 9 February 1976 on the implementation of the principle of equal treatment for men and women as regards access to employment, vocational training and promotion, and working conditions(5).
(3) In implementing the principle of equal treatment, the Community should, in accordance with Article 3(2) of the EC Treaty, aim to eliminate inequalities, and to promote equality between men and women, especially since women are often the victims of multiple discrimination.
(4) The right of all persons to equality before the law and protection against discrimination constitutes a universal right recognised by the Universal Declaration of Human Rights, the United Nations Convention on the Elimination of All Forms of Discrimination against Women, United Nations Covenants on Civil and Political Rights and on Economic, Social and Cultural Rights and by the European Convention for the Protection of Human Rights and Fundamental Freedoms, to which all Member States are signatories. Convention No 111 of the International Labour Organisation (ILO) prohibits discrimination in the field of employment and occupation.
(5) It is important to respect such fundamental rights and freedoms. This Directive does not prejudice freedom of association, including the right to establish unions with others and to join unions to defend one's interests.
(6) The Community Charter of the Fundamental Social Rights of Workers recognises the importance of combating every form of discrimination, including the need to take appropriate action for the social and economic integration of elderly and disabled people.
(7) The EC Treaty includes among its objectives the promotion of coordination between employment policies of the Member States. To this end, a new employment chapter was incorporated in the EC Treaty as a means of developing a coordinated European strategy for employment to promote a skilled, trained and adaptable workforce.
(8) The Employment Guidelines for 2000 agreed by the European Council at Helsinki on 10 and 11 December 1999 stress the need to foster a labour market favourable to social integration by formulating a coherent set of policies aimed at combating discrimination against groups such as persons with disability. They also emphasise the need to pay particular attention to supporting older workers, in order to increase their participation in the labour force.
(9) Employment and occupation are key elements in guaranteeing equal opportunities for all and contribute strongly to the full participation of citizens in economic, cultural and social life and to realising their potential.
(10) On 29 June 2000 the Council adopted Directive 2000/43/EC(6) implementing the principle of equal treatment between persons irrespective of racial or ethnic origin. That Directive already provides protection against such discrimination in the field of employment and occupation.
(11) Discrimination based on religion or belief, disability, age or sexual orientation may undermine the achievement of the objectives of the EC Treaty, in particular the attainment of a high level of employment and social protection, raising the standard of living and the quality of life, economic and social cohesion and solidarity, and the free movement of persons.
(12) To this end, any direct or indirect discrimination based on religion or belief, disability, age or sexual orientation as regards the areas covered by this Directive should be prohibited throughout the Community. This prohibition of discrimination should also apply to nationals of third countries but does not cover differences of treatment based on nationality and is without prejudice to provisions governing the entry and residence of third-country nationals and their access to employment and occupation.
(13) This Directive does not apply to social security and social protection schemes whose benefits are not treated as income within the meaning given to that term for the purpose of applying Article 141 of the EC Treaty, nor to any kind of payment by the State aimed at providing access to employment or maintaining employment.
(14) This Directive shall be without prejudice to national provisions laying down retirement ages.
(15) The appreciation of the facts from which it may be inferred that there has been direct or indirect discrimination is a matter for national judicial or other competent bodies, in accordance with rules of national law or practice. Such rules may provide, in particular, for indirect discrimination to be established by any means including on the basis of statistical evidence.
(16) The provision of measures to accommodate the needs of disabled people at the workplace plays an important role in combating discrimination on grounds of disability.
(17) This Directive does not require the recruitment, promotion, maintenance in employment or training of an individual who is not competent, capable and available to perform the essential functions of the post concerned or to undergo the relevant training, without prejudice to the obligation to provide reasonable accommodation for people with disabilities.
(18) This Directive does not require, in particular, the armed forces and the police, prison or emergency services to recruit or maintain in employment persons who do not have the required capacity to carry out the range of functions that they may be called upon to perform with regard to the legitimate objective of preserving the operational capacity of those services.
(19) Moreover, in order that the Member States may continue to safeguard the combat effectiveness of their armed forces, they may choose not to apply the provisions of this Directive concerning disability and age to all or part of their armed forces. The Member States which make that choice must define the scope of that derogation.
(20) Appropriate measures should be provided, i.e. effective and practical measures to adapt the workplace to the disability, for example adapting premises and equipment, patterns of working time, the distribution of tasks or the provision of training or integration resources.
(21) To determine whether the measures in question give rise to a disproportionate burden, account should be taken in particular of the financial and other costs entailed, the scale and financial resources of the organisation or undertaking and the possibility of obtaining public funding or any other assistance.
(22) This Directive is without prejudice to national laws on marital status and the benefits dependent thereon.
(23) In very limited circumstances, a difference of treatment may be justified where a characteristic related to religion or belief, disability, age or sexual orientation constitutes a genuine and determining occupational requirement, when the objective is legitimate and the requirement is proportionate. Such circumstances should be included in the information provided by the Member States to the Commission.
(24) The European Union in its Declaration No 11 on the status of churches and non-confessional organisations, annexed to the Final Act of the Amsterdam Treaty, has explicitly recognised that it respects and does not prejudice the status under national law of churches and religious associations or communities in the Member States and that it equally respects the status of philosophical and non-confessional organisations. With this in view, Member States may maintain or lay down specific provisions on genuine, legitimate and justified occupational requirements which might be required for carrying out an occupational activity.
(25) The prohibition of age discrimination is an essential part of meeting the aims set out in the Employment Guidelines and encouraging diversity in the workforce. However, differences in treatment in connection with age may be justified under certain circumstances and therefore require specific provisions which may vary in accordance with the situation in Member States. It is therefore essential to distinguish between differences in treatment which are justified, in particular by legitimate employment policy, labour market and vocational training objectives, and discrimination which must be prohibited.
(26) The prohibition of discrimination should be without prejudice to the maintenance or adoption of measures intended to prevent or compensate for disadvantages suffered by a group of persons of a particular religion or belief, disability, age or sexual orientation, and such measures may permit organisations of persons of a particular religion or belief, disability, age or sexual orientation where their main object is the promotion of the special needs of those persons.
(27) In its Recommendation 86/379/EEC of 24 July 1986 on the employment of disabled people in the Community(7), the Council established a guideline framework setting out examples of positive action to promote the employment and training of disabled people, and in its Resolution of 17 June 1999 on equal employment opportunities for people with disabilities(8), affirmed the importance of giving specific attention inter alia to recruitment, retention, training and lifelong learning with regard to disabled persons.
(28) This Directive lays down minimum requirements, thus giving the Member States the option of introducing or maintaining more favourable provisions. The implementation of this Directive should not serve to justify any regression in relation to the situation which already prevails in each Member State.
(29) Persons who have been subject to discrimination based on religion or belief, disability, age or sexual orientation should have adequate means of legal protection. To provide a more effective level of protection, associations or legal entities should also be empowered to engage in proceedings, as the Member States so determine, either on behalf or in support of any victim, without prejudice to national rules of procedure concerning representation and defence before the courts.
(30) The effective implementation of the principle of equality requires adequate judicial protection against victimisation.
(31) The rules on the burden of proof must be adapted when there is a prima facie case of discrimination and, for the principle of equal treatment to be applied effectively, the burden of proof must shift back to the respondent when evidence of such discrimination is brought. However, it is not for the respondent to prove that the plaintiff adheres to a particular religion or belief, has a particular disability, is of a particular age or has a particular sexual orientation.
(32) Member States need not apply the rules on the burden of proof to proceedings in which it is for the court or other competent body to investigate the facts of the case. The procedures thus referred to are those in which the plaintiff is not required to prove the facts, which it is for the court or competent body to investigate.
(33) Member States should promote dialogue between the social partners and, within the framework of national practice, with non-governmental organisations to address different forms of discrimination at the workplace and to combat them.
(34) The need to promote peace and reconciliation between the major communities in Northern Ireland necessitates the incorporation of particular provisions into this Directive.
(35) Member States should provide for effective, proportionate and dissuasive sanctions in case of breaches of the obligations under this Directive.
(36) Member States may entrust the social partners, at their joint request, with the implementation of this Directive, as regards the provisions concerning collective agreements, provided they take any necessary steps to ensure that they are at all times able to guarantee the results required by this Directive.
(37) In accordance with the principle of subsidiarity set out in Article 5 of the EC Treaty, the objective of this Directive, namely the creation within the Community of a level playing-field as regards equality in employment and occupation, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale and impact of the action, be better achieved at Community level. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective,
CHAPTER I
GENERAL PROVISIONS
Article 1
Purpose
The purpose of this Directive is to lay down a general framework for combating discrimination on the grounds of religion or belief, disability, age or sexual orientation as regards employment and occupation, with a view to putting into effect in the Member States the principle of equal treatment.
Article 2
Concept of discrimination
1. For the purposes of this Directive, the "principle of equal treatment" shall mean that there shall be no direct or indirect discrimination whatsoever on any of the grounds referred to in Article 1.
2. For the purposes of paragraph 1:
(a) direct discrimination shall be taken to occur where one person is treated less favourably than another is, has been or would be treated in a comparable situation, on any of the grounds referred to in Article 1;
(b) indirect discrimination shall be taken to occur where an apparently neutral provision, criterion or practice would put persons having a particular religion or belief, a particular disability, a particular age, or a particular sexual orientation at a particular disadvantage compared with other persons unless:
(i) that provision, criterion or practice is objectively justified by a legitimate aim and the means of achieving that aim are appropriate and necessary, or
(ii) as regards persons with a particular disability, the employer or any person or organisation to whom this Directive applies, is obliged, under national legislation, to take appropriate measures in line with the principles contained in Article 5 in order to eliminate disadvantages entailed by such provision, criterion or practice.
3. Harassment shall be deemed to be a form of discrimination within the meaning of paragraph 1, when unwanted conduct related to any of the grounds referred to in Article 1 takes place with the purpose or effect of violating the dignity of a person and of creating an intimidating, hostile, degrading, humiliating or offensive environment. In this context, the concept of harassment may be defined in accordance with the national laws and practice of the Member States.
4. An instruction to discriminate against persons on any of the grounds referred to in Article 1 shall be deemed to be discrimination within the meaning of paragraph 1.
5. This Directive shall be without prejudice to measures laid down by national law which, in a democratic society, are necessary for public security, for the maintenance of public order and the prevention of criminal offences, for the protection of health and for the protection of the rights and freedoms of others.
Article 3
Scope
1. Within the limits of the areas of competence conferred on the Community, this Directive shall apply to all persons, as regards both the public and private sectors, including public bodies, in relation to:
(a) conditions for access to employment, to self-employment or to occupation, including selection criteria and recruitment conditions, whatever the branch of activity and at all levels of the professional hierarchy, including promotion;
(b) access to all types and to all levels of vocational guidance, vocational training, advanced vocational training and retraining, including practical work experience;
(c) employment and working conditions, including dismissals and pay;
(d) membership of, and involvement in, an organisation of workers or employers, or any organisation whose members carry on a particular profession, including the benefits provided for by such organisations.
2. This Directive does not cover differences of treatment based on nationality and is without prejudice to provisions and conditions relating to the entry into and residence of third-country nationals and stateless persons in the territory of Member States, and to any treatment which arises from the legal status of the third-country nationals and stateless persons concerned.
3. This Directive does not apply to payments of any kind made by state schemes or similar, including state social security or social protection schemes.
4. Member States may provide that this Directive, in so far as it relates to discrimination on the grounds of disability and age, shall not apply to the armed forces.
Article 4
Occupational requirements
1. Notwithstanding Article 2(1) and (2), Member States may provide that a difference of treatment which is based on a characteristic related to any of the grounds referred to in Article 1 shall not constitute discrimination where, by reason of the nature of the particular occupational activities concerned or of the context in which they are carried out, such a characteristic constitutes a genuine and determining occupational requirement, provided that the objective is legitimate and the requirement is proportionate.
2. Member States may maintain national legislation in force at the date of adoption of this Directive or provide for future legislation incorporating national practices existing at the date of adoption of this Directive pursuant to which, in the case of occupational activities within churches and other public or private organisations the ethos of which is based on religion or belief, a difference of treatment based on a person's religion or belief shall not constitute discrimination where, by reason of the nature of these activities or of the context in which they are carried out, a person's religion or belief constitute a genuine, legitimate and justified occupational requirement, having regard to the organisation's ethos. This difference of treatment shall be implemented taking account of Member States' constitutional provisions and principles, as well as the general principles of Community law, and should not justify discrimination on another ground.
Provided that its provisions are otherwise complied with, this Directive shall thus not prejudice the right of churches and other public or private organisations, the ethos of which is based on religion or belief, acting in conformity with national constitutions and laws, to require individuals working for them to act in good faith and with loyalty to the organisation's ethos.
Article 5
Reasonable accommodation for disabled persons
In order to guarantee compliance with the principle of equal treatment in relation to persons with disabilities, reasonable accommodation shall be provided. This means that employers shall take appropriate measures, where needed in a particular case, to enable a person with a disability to have access to, participate in, or advance in employment, or to undergo training, unless such measures would impose a disproportionate burden on the employer. This burden shall not be disproportionate when it is sufficiently remedied by measures existing within the framework of the disability policy of the Member State concerned.
Article 6
Justification of differences of treatment on grounds of age
1. Notwithstanding Article 2(2), Member States may provide that differences of treatment on grounds of age shall not constitute discrimination, if, within the context of national law, they are objectively and reasonably justified by a legitimate aim, including legitimate employment policy, labour market and vocational training objectives, and if the means of achieving that aim are appropriate and necessary.
Such differences of treatment may include, among others:
(a) the setting of special conditions on access to employment and vocational training, employment and occupation, including dismissal and remuneration conditions, for young people, older workers and persons with caring responsibilities in order to promote their vocational integration or ensure their protection;
(b) the fixing of minimum conditions of age, professional experience or seniority in service for access to employment or to certain advantages linked to employment;
(c) the fixing of a maximum age for recruitment which is based on the training requirements of the post in question or the need for a reasonable period of employment before retirement.
2. Notwithstanding Article 2(2), Member States may provide that the fixing for occupational social security schemes of ages for admission or entitlement to retirement or invalidity benefits, including the fixing under those schemes of different ages for employees or groups or categories of employees, and the use, in the context of such schemes, of age criteria in actuarial calculations, does not constitute discrimination on the grounds of age, provided this does not result in discrimination on the grounds of sex.
Article 7
Positive action
1. With a view to ensuring full equality in practice, the principle of equal treatment shall not prevent any Member State from maintaining or adopting specific measures to prevent or compensate for disadvantages linked to any of the grounds referred to in Article 1.
2. With regard to disabled persons, the principle of equal treatment shall be without prejudice to the right of Member States to maintain or adopt provisions on the protection of health and safety at work or to measures aimed at creating or maintaining provisions or facilities for safeguarding or promoting their integration into the working environment.
Article 8
Minimum requirements
1. Member States may introduce or maintain provisions which are more favourable to the protection of the principle of equal treatment than those laid down in this Directive.
2. The implementation of this Directive shall under no circumstances constitute grounds for a reduction in the level of protection against discrimination already afforded by Member States in the fields covered by this Directive.
CHAPTER II
REMEDIES AND ENFORCEMENT
Article 9
Defence of rights
1. Member States shall ensure that judicial and/or administrative procedures, including where they deem it appropriate conciliation procedures, for the enforcement of obligations under this Directive are available to all persons who consider themselves wronged by failure to apply the principle of equal treatment to them, even after the relationship in which the discrimination is alleged to have occurred has ended.
2. Member States shall ensure that associations, organisations or other legal entities which have, in accordance with the criteria laid down by their national law, a legitimate interest in ensuring that the provisions of this Directive are complied with, may engage, either on behalf or in support of the complainant, with his or her approval, in any judicial and/or administrative procedure provided for the enforcement of obligations under this Directive.
3. Paragraphs 1 and 2 are without prejudice to national rules relating to time limits for bringing actions as regards the principle of equality of treatment.
Article 10
Burden of proof
1. Member States shall take such measures as are necessary, in accordance with their national judicial systems, to ensure that, when persons who consider themselves wronged because the principle of equal treatment has not been applied to them establish, before a court or other competent authority, facts from which it may be presumed that there has been direct or indirect discrimination, it shall be for the respondent to prove that there has been no breach of the principle of equal treatment.
2. Paragraph 1 shall not prevent Member States from introducing rules of evidence which are more favourable to plaintiffs.
3. Paragraph 1 shall not apply to criminal procedures.
4. Paragraphs 1, 2 and 3 shall also apply to any legal proceedings commenced in accordance with Article 9(2).
5. Member States need not apply paragraph 1 to proceedings in which it is for the court or competent body to investigate the facts of the case.
Article 11
Victimisation
Member States shall introduce into their national legal systems such measures as are necessary to protect employees against dismissal or other adverse treatment by the employer as a reaction to a complaint within the undertaking or to any legal proceedings aimed at enforcing compliance with the principle of equal treatment.
Article 12
Dissemination of information
Member States shall take care that the provisions adopted pursuant to this Directive, together with the relevant provisions already in force in this field, are brought to the attention of the persons concerned by all appropriate means, for example at the workplace, throughout their territory.
Article 13
Social dialogue
1. Member States shall, in accordance with their national traditions and practice, take adequate measures to promote dialogue between the social partners with a view to fostering equal treatment, including through the monitoring of workplace practices, collective agreements, codes of conduct and through research or exchange of experiences and good practices.
2. Where consistent with their national traditions and practice, Member States shall encourage the social partners, without prejudice to their autonomy, to conclude at the appropriate level agreements laying down anti-discrimination rules in the fields referred to in Article 3 which fall within the scope of collective bargaining. These agreements shall respect the minimum requirements laid down by this Directive and by the relevant national implementing measures.
Article 14
Dialogue with non-governmental organisations
Member States shall encourage dialogue with appropriate non-governmental organisations which have, in accordance with their national law and practice, a legitimate interest in contributing to the fight against discrimination on any of the grounds referred to in Article 1 with a view to promoting the principle of equal treatment.
CHAPTER III
PARTICULAR PROVISIONS
Article 15
Northern Ireland
1. In order to tackle the under-representation of one of the major religious communities in the police service of Northern Ireland, differences in treatment regarding recruitment into that service, including its support staff, shall not constitute discrimination insofar as those differences in treatment are expressly authorised by national legislation.
2. In order to maintain a balance of opportunity in employment for teachers in Northern Ireland while furthering the reconciliation of historical divisions between the major religious communities there, the provisions on religion or belief in this Directive shall not apply to the recruitment of teachers in schools in Northern Ireland in so far as this is expressly authorised by national legislation.
CHAPTER IV
FINAL PROVISIONS
Article 16
Compliance
Member States shall take the necessary measures to ensure that:
(a) any laws, regulations and administrative provisions contrary to the principle of equal treatment are abolished;
(b) any provisions contrary to the principle of equal treatment which are included in contracts or collective agreements, internal rules of undertakings or rules governing the independent occupations and professions and workers' and employers' organisations are, or may be, declared null and void or are amended.
Article 17
Sanctions
Member States shall lay down the rules on sanctions applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are applied. The sanctions, which may comprise the payment of compensation to the victim, must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by 2 December 2003 at the latest and shall notify it without delay of any subsequent amendment affecting them.
Article 18
Implementation
Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive by 2 December 2003 at the latest or may entrust the social partners, at their joint request, with the implementation of this Directive as regards provisions concerning collective agreements. In such cases, Member States shall ensure that, no later than 2 December 2003, the social partners introduce the necessary measures by agreement, the Member States concerned being required to take any necessary measures to enable them at any time to be in a position to guarantee the results imposed by this Directive. They shall forthwith inform the Commission thereof.
In order to take account of particular conditions, Member States may, if necessary, have an additional period of 3 years from 2 December 2003, that is to say a total of 6 years, to implement the provisions of this Directive on age and disability discrimination. In that event they shall inform the Commission forthwith. Any Member State which chooses to use this additional period shall report annually to the Commission on the steps it is taking to tackle age and disability discrimination and on the progress it is making towards implementation. The Commission shall report annually to the Council.
When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
Article 19
Report
1. Member States shall communicate to the Commission, by 2 December 2005 at the latest and every five years thereafter, all the information necessary for the Commission to draw up a report to the European Parliament and the Council on the application of this Directive.
2. The Commission's report shall take into account, as appropriate, the viewpoints of the social partners and relevant non-governmental organisations. In accordance with the principle of gender mainstreaming, this report shall, inter alia, provide an assessment of the impact of the measures taken on women and men. In the light of the information received, this report shall include, if necessary, proposals to revise and update this Directive.
Article 20
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 21
Addressees
This Directive is addressed to the Member States.
|
[
"UKSI20032037",
"UKSI20032828",
"UKSI20032827",
"UKPGA19990017",
"UKSI20031661",
"UKPGA20010010",
"UKSI20031660",
"UKPGA19980031",
"UKSI20031673",
"UKSI19962803",
"UKSI20032770",
"UKPGA19950050"
] |
32000L0079
|
2000
|
Council Directive 2000/79/EC of 27 November 2000 concerning the European Agreement on the Organisation of Working Time of Mobile Workers in Civil Aviation concluded by the Association of European Airlines (AEA), the European Transport Workers' Federation (ETF), the European Cockpit Association (ECA), the European Regions Airline Association (ERA) and the International Air Carrier Association (IACA) (Text with EEA relevance)
Having regard to the Treaty establishing the European Community, and in particular Article 139(2) thereof,
Having regard to the proposal from the Commission,
Whereas:
(1) Management and labour may, in accordance with Article 139(2) of the Treaty, request jointly that agreements concluded at Community level be implemented by a Council decision on a proposal from the Commission.
(2) The Council adopted Directive 93/104/EC(1) concerning certain aspects of the organisation of working time. Civil aviation was one of the sectors and activities excluded from the scope of that Directive. The European Parliament and the Council adopted Directive 2000/34/EC amending Directive 93/104/EC in order to cover sectors and activities previously excluded.
(3) The Commission, in accordance with Article 138(2) of the Treaty, has consulted management and labour on the possible direction of Community action with regard to the sectors and activities excluded from Directive 93/104/EC.
(4) The Commission, considering after such consultation that Community action was desirable, once again consulted management and labour at Community level on the substance of the envisaged proposal in accordance with Article 138(3) of the Treaty.
(5) The Association of European Airlines (AEA), the European Transport Workers' Federation (ETF), the European Cockpit Association (ECA), the European Regions Airline Association (ERA) and the International Air Carrier Association (IACA) have informed the Commission of their desire to enter into negotiations in accordance with Article 138(4) of the Treaty.
(6) The said organisations concluded, on 22 March 2000, a European Agreement on the Organisation of Working Time of Mobile Staff in Civil Aviation.
(7) This Agreement contains a joint request to the Commission to implement the Agreement by a Council decision on a proposal from the Commission, in accordance with Article 139(2) of the Treaty.
(8) This Directive and the Agreement lay down more specific requirements within the meaning of Article 14 of Directive 93/104/EC as regards the organisation of working time of mobile staff in civil aviation.
(9) Article 2(7) of Directive 93/104/EC defines mobile workers as any worker employed as a member of travelling or flying personnel by an undertaking which operates transport services for passengers or goods by road, air or inland waterway.
(10) The proper instrument for implementing the Agreement is a Directive within the meaning of Article 249 of the Treaty.
(11) In view of the highly integrated nature of the civil aviation sector and the conditions of competition prevailing in it, the objectives of this Directive to protect workers' health and safety cannot be sufficiently achieved by the Member States and Community action is therefore required in accordance with the subsidiarity principle laid down in Article 5 of the Treaty. This Directive does not go beyond what is necessary to achieve those objectives.
(12) With regard to terms used in the Agreement which are not specifically defined therein, this Directive leaves Member States free to define those terms in accordance with national law and practice, as is the case for other social policy Directives using similar terms, providing that the said definitions are compatible with the Agreement.
(13) The Commission has drafted its proposal for a Directive, in accordance with its Communication of 20 May 1998 "Adapting and promoting the social dialogue at Community level", taking into account the representative status of the signatory parties and the legality of each clause of the Agreement. The signatory parties together have a sufficiently representative status for flying personnel employed by an undertaking which operates transport services for passengers or goods in civil aviation.
(14) The Commission has drafted its proposal for a Directive in compliance with Article 137(2) of the Treaty which provides that directives in the social policy domain "shall avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings".
(15) This Directive and the Agreement establish minimum standards. Member States and/or management and labour may maintain or introduce more favourable provisions.
(16) Implementation of this Directive should not serve to justify any regression in relation to the situation which already exists in each Member State.
(17) The Commission has informed the European Parliament, the Economic and Social Committee and the Committee of the Regions by sending them the text of its proposal for a Directive incorporating the Agreement.
(18) The European Parliament adopted a Resolution on the social partners' framework agreement on 3 October 2000.
(19) The implementation of the Agreement contributes to achieving the objectives under Article 136 of the Treaty,
Article 1
The purpose of this Directive is to implement the European Agreement on the organisation of working time of mobile staff in civil aviation concluded on 22 March 2000 between the organisations representing management and labour in the civil aviation sector: the Association of European Airlines (AEA), the European Transport Workers' Federation (ETF), the European Cockpit Association (ECA), the European Regions Airline Association (ERA) and the International Air Carrier Association (IACA).
The text of the Agreement appears in the Annex.
Article 2
1. Member States may maintain or introduce more favourable provisions than those laid down in this Directive.
2. The implementation of this Directive shall under no circumstances constitute sufficient grounds for justifying a reduction in the general level of protection of workers in the fields covered by this Directive. This shall be without prejudice to the rights of Member States and/or management and labour to lay down, in the light of changing circumstances, different legislative, regulatory or contractual arrangements to those prevailing at the time of the adoption of this Directive, provided always that the minimum requirements laid down in this Directive are complied with.
Article 3
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 December 2003 or shall ensure that, by that date at the latest, management and labour have introduced the necessary measures by agreement. The Member States shall take any necessary measure to enable them at any time to be in a position to guarantee the results imposed by this Directive. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
Article 4
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 5
This Directive is addressed to the Member States.
|
[
"UKSI20040756"
] |
32000L0076
|
2000
|
Directive 2000/76/EC of the European Parliament and of the Council of 4 December 2000 on the incineration of waste
Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,
Having regard to the proposal from the Commission(1),
Having regard to the Opinion of the Economic and Social Committee(2),
Having regard to the Opinion of the Committee of the Regions(3),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(4), and in the light of the joint text approved by the Conciliation Committee on 11 October 2000,
Whereas:
(1) The fifth Environment Action Programme: Towards sustainability - A European Community programme of policy and action in relation to the environment and sustainable development, supplemented by Decision No 2179/98/EC on its review(5), sets as an objective that critical loads and levels of certain pollutants such as nitrogen oxides (NOx), sulphur dioxide (SO2), heavy metals and dioxins should not be exceeded, while in terms of air quality the objective is that all people should be effectively protected against recognised health risks from air pollution. That Programme further sets as an objective a 90 % reduction of dioxin emissions of identified sources by 2005 (1985 level) and at least 70 % reduction from all pathways of cadmium (Cd), mercury (Hg) and lead (Pb) emissions in 1995.
(2) The Protocol on persistent organic pollutants signed by the Community within the framework of the United Nations Economic Commission for Europe (UN-ECE) Convention on long-range transboundary air pollution sets legally binding limit values for the emission of dioxins and furans of 0,1 ng/m; TE (Toxicity Equivalents) for installations burning more than 3 tonnes per hour of municipal solid waste, 0,5 ng/m; TE for installations burning more than 1 tonne per hour of medical waste, and 0,2 ng/m; TE for installations burning more than 1 tonne per hour of hazardous waste.
(3) The Protocol on Heavy Metals signed by the Community within the framework of the UN-ECE Convention on long-range transboundary air pollution sets legally binding limit values for the emission of particulate of 10 mg/m3 for hazardous and medical waste incineration and for the emission of mercury of 0,05 mg/m3 for hazardous waste incineration and 0,08 mg/m3 for municipal waste incineration.
(4) The International Agency for Research on Cancer and the World Health Organisation indicate that some polycyclic aromatic hydrocarbons (PAHs) are carcinogenic. Therefore, Member States may set emission limit values for PAHs among other pollutants.
(5) In accordance with the principles of subsidiarity and proportionality as set out in Article 5 of the Treaty, there is a need to take action at the level of the Community. The precautionary principle provides the basis for further measures. This Directive confines itself to minimum requirements for incineration and co-incineration plants.
(6) Further, Article 174 provides that Community policy on the environment is to contribute to protecting human health.
(7) Therefore, a high level of environmental protection and human health protection requires the setting and maintaining of stringent operational conditions, technical requirements and emission limit values for plants incinerating or co-incinerating waste within the Community. The limit values set should prevent or limit as far as practicable negative effects on the environment and the resulting risks to human health.
(8) The Communication from the Commission on the review of the Community Strategy for waste management assigns prevention of waste the first priority, followed by reuse and recovery and finally by safe disposal of waste; in its Resolution of 24 February 1997 on a Community Strategy for waste management(6), the Council reiterated its conviction that waste prevention should be the first priority of any rational waste policy in relation to minimising waste production and the hazardous properties of waste.
(9) In its Resolution of 24 February 1997 the Council also underlines the importance of Community criteria concerning the use of waste, the need for appropriate emission standards to apply to incineration facilities, the need for monitoring measures to be envisaged for existing incineration plants, and the need for the Commission to consider amending Community legislation in relation to the incineration of waste with energy recovery in order to avoid large-scale movements of waste for incineration or co-incineration in the Community.
(10) It is necessary to set strict rules for all plants incinerating or co-incinerating waste in order to avoid transboundary movements to plants operating at lower costs due to less stringent environmental standards.
(11) The Communication from the Commission/energy for the future: renewable sources of energy/White paper for a Community strategy and action plan takes into consideration in particular the use of biomass for energy purposes.
(12) Council Directive 96/61/EC(7) sets out an integrated approach to pollution prevention and control in which all the aspects of an installations environmental performance are considered in an integrated manner. Installations for the incineration of municipal waste with a capacity exceeding 3 tonnes per hour and installations for the disposal or recovery of hazardous waste with a capacity exceeding 10 tonnes per day are included within the scope of the said Directive.
(13) Compliance with the emission limit values laid down by this Directive should be regarded as a necessary but not sufficient condition for compliance with the requirements of Directive 96/61/EC. Such compliance may involve more stringent emissions limit values for the pollutants envisaged by this Directive, emission limit values for other substances and other media, and other appropriate conditions.
(14) Industrial experience in the implementation of techniques for the reduction of polluting emissions from incineration plants has been acquired over a period of ten years.
(15) Council Directives 89/369/EEC(8) and 89/429/EEC(9) on the prevention and reduction of air pollution from municipal waste incineration plants have contributed to the reduction and control of atmospheric emissions from incineration plants. More stringent rules should now be adopted and those Directives should accordingly be repealed.
(16) The distinction between hazardous and non-hazardous waste is based principally on the properties of waste prior to incineration or co-incineration but not on differences in emissions. The same emission limit values should apply to the incineration or co-incineration of hazardous and non-hazardous waste but different techniques and conditions of incineration or co-incineration and different monitoring measures upon reception of waste should be retained.
(17) Member States should take into account Council Directive 1999/30/EC of 22 April 1999 relating to limit values for sulphur dioxide, nitrogen dioxide and oxides of nitrogen, particulate matter and lead in ambient air(10) when implementing this Directive.
(18) The incineration of hazardous waste with a content of more than 1 % of halogenated organic substances, expressed as chlorine, has to comply with certain operational conditions in order to destroy as many organic pollutants such as dioxins as possible.
(19) The incineration of waste which contains chlorine generates flue gas residues. Such residues should be managed in a way that minimises their amount and harmfulness.
(20) There may be grounds to provide for specified exemptions to the emission limit values for some pollutants during a specified time limit and subject to specific conditions.
(21) Criteria for certain sorted combustible fraction of non-hazardous waste not suitable for recycling, should be developed in order to allow the authorisation of the reduction of the frequency of periodical measurements.
(22) A single text on the incineration of waste will improve legal clarity and enforceability. There should be a single directive for the incineration and co-incineration of hazardous and non-hazardous waste taking fully into account the substance and structure of Council Directive 94/67/EC of 16 December 1994 on the incineration of hazardous waste(11). Therefore Directive 94/67/EC should also be repealed.
(23) Article 4 of Council Directive 75/442/EEC of 15 July 1975 on waste(12) requires Member States to take the necessary measures to ensure that waste is recovered or disposed of without endangering human health and without harming the environment. To this end, Articles 9 and 10 of that Directive provide that any plant or undertaking treating waste must obtain a permit from the competent authorities relating, inter alia, to the precautions to be taken.
(24) The requirements for recovering the heat generated by the incineration or co-incineration process and for minimising and recycling residues resulting from the operation of incineration or co-incineration plants will assist in meeting the objectives of Article 3 on the waste hierarchy of Directive 75/442/EEC.
(25) Incineration and co-incineration plants treating only animal waste regulated by Directive 90/667/EEC(13) are excluded from the scope of this Directive. The Commission intends to propose a revision to the requirements of Directive 90/667 with a view to providing for high environmental standards for the incineration and co-incineration of animal waste.
(26) The permit for an incineration or co-incineration plant shall also comply with any applicable requirements laid down in Directives 91/271/EEC(14), 96/61/EC, 96/62/EC(15), 76/464/EEC(16), and 1999/31/EC(17).
(27) The co-incineration of waste in plants not primarily intended to incinerate waste should not be allowed to cause higher emissions of polluting substances in that part of the exhaust gas volume resulting from such co-incineration than those permitted for dedicated incineration plants and should therefore be subject to appropriate limitations.
(28) High-standard measurement techniques are required to monitor emissions to ensure compliance with the emission limit values for the pollutants.
(29) The introduction of emission limit values for the discharge of waste water from the cleaning of exhaust gases from incineration and co-incineration plants will limit a transfer of pollutants from the air into water.
(30) Provisions should be laid down for cases where the emission limit values are exceeded as well as for technically unavoidable stoppages, disturbances or failures of the purification devices or the measurement devices.
(31) In order to ensure transparency of the permitting process throughout the Community the public should have access to information with a view to allowing it to be involved in decisions to be taken following applications for new permits and their subsequent updates. The public should have access to reports on the functioning and monitoring of the plants burning more than three tonnes per hour in order to be informed of their potential effects on the environment and human health.
(32) The Commission should present a report both to the European Parliament and the Council based on the experience of applying this Directive, the new scientific knowledge gained, the development of the state of technology, the progress achieved in emission control techniques, and on the experience made in waste management and operation of the plants and on the development of environmental requirements, with a view to proposing, as appropriate, to adapt the related provisions of this Directive.
(33) The measures necessary for the implementation of this Directive are to be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(18).
(34) Member States should lay down rules on penalties applicable to infringements of the provisions of this Directive and ensure that they are implemented; those penalties should be effective, proportionate and dissuasive,
Article 1
Objectives
The aim of this Directive is to prevent or to limit as far as practicable negative effects on the environment, in particular pollution by emissions into air, soil, surface water and groundwater, and the resulting risks to human health, from the incineration and co-incineration of waste.
This aim shall be met by means of stringent operational conditions and technical requirements, through setting emission limit values for waste incineration and co-incineration plants within the Community and also through meeting the requirements of Directive 75/442/EEC.
Article 2
Scope
1. This Directive covers incineration and co-incineration plants.
2. The following plants shall however be excluded from the scope of this Directive:
(a) Plants treating only the following wastes:
(i) vegetable waste from agriculture and forestry,
(ii) vegetable waste from the food processing industry, if the heat generated is recovered,
(iii) fibrous vegetable waste from virgin pulp production and from production of paper from pulp, if it is co-incinerated at the place of production and the heat generated is recovered,
(iv) wood waste with the exception of wood waste which may contain halogenated organic compounds or heavy metals as a result of treatment with wood-preservatives or coating, and which includes in particular such wood waste originating from construction and demolition waste,
(v) cork waste,
(vi) radioactive waste,
(vii) animal carcasses as regulated by Directive 90/667/EEC without prejudice to its future amendments,
(viii) waste resulting from the exploration for, and the exploitation of, oil and gas resources from off-shore installations and incinerated on board the installation;
(b) Experimental plants used for research, development and testing in order to improve the incineration process and which treat less than 50 tonnes of waste per year.
Article 3
Definitions
For the purposes of this Directive:
1. "waste" means any solid or liquid waste as defined in Article 1(a) of Directive 75/442/EEC;
2. "hazardous waste" means any solid or liquid waste as defined in Article 1(4) of Council Directive 91/689/EEC of 12 December 1991 on hazardous waste(19).
For the following hazardous wastes, the specific requirements for hazardous waste in this Directive shall not apply:
(a) combustible liquid wastes including waste oils as defined in Article 1 of Council Directive 75/439/EEC of 16 June 1975 on the disposal of waste oils(20) provided that they meet the following criteria:
(i) the mass content of polychlorinated aromatic hydrocarbons, e.g. polychlorinated biphenyls (PCB) or pentachlorinated phenol (PCP) amounts to concentrations not higher than those set out in the relevant Community legislation;
(ii) these wastes are not rendered hazardous by virtue of containing other constituents listed in Annex II to Directive 91/689/EEC in quantities or in concentrations which are inconsistent with the achievement of the objectives set out in Article 4 of Directive 75/442/EEC; and
(iii) the net calorific value amounts to at least 30 MJ per kilogramme,
(b) any combustible liquid wastes which cannot cause, in the flue gas directly resulting from their combustion, emissions other than those from gasoil as defined in Article 1(1) of Directive 93/12/EEC(21) or a higher concentration of emissions than those resulting from the combustion of gasoil as so defined;
3. "mixed municipal waste" means waste from households as well as commercial, industrial and institutional waste, which because of its nature and composition is similar to waste from households, but excluding fractions indicated in the Annex to Decision 94/3/EC(22) under heading 20 01 that are collected separately at source and excluding the other wastes indicated under heading 20 02 of that Annex;
4. "incineration plant" means any stationary or mobile technical unit and equipment dedicated to the thermal treatment of wastes with or without recovery of the combustion heat generated. This includes the incineration by oxidation of waste as well as other thermal treatment processes such as pyrolysis, gasification or plasma processes in so far as the substances resulting from the treatment are subsequently incinerated.
This definition covers the site and the entire incineration plant including all incineration lines, waste reception, storage, on site pretreatment facilities, waste-fuel and air-supply systems, boiler, facilities for the treatment of exhaust gases, on-site facilities for treatment or storage of residues and waste water, stack, devices and systems for controlling incineration operations, recording and monitoring incineration conditions;
5. "co-incineration plant" means any stationary or mobile plant whose main purpose is the generation of energy or production of material products and:
- which uses wastes as a regular or additional fuel; or
- in which waste is thermally treated for the purpose of disposal.
If co-incineration takes place in such a way that the main purpose of the plant is not the generation of energy or production of material products but rather the thermal treatment of waste, the plant shall be regarded as an incineration plant within the meaning of point 4.
This definition covers the site and the entire plant including all co-incineration lines, waste reception, storage, on site pretreatment facilities, waste-, fuel- and air-supply systems, boiler, facilities for the treatment of exhaust gases, on-site facilities for treatment or storage of residues and waste water, stack devices and systems for controlling incineration operations, recording and monitoring incineration conditions;
6. "existing co-incineration or co-incineration plant" means an incineration or co-incineration plant:
(a) which is in operation and has a permit in accordance with existing Community legislation before 28 December 2002, or,
(b) which is authorised or registered for incineration or co-incineration and has a permit issued before 28 December 2002 in accordance with existing Community legislation, provided that the plant is put into operation not later than 28 December 2003, or
(c) which, in the view of the competent authority, is the subject of a full request for a permit, before 28 December 2002, provided that the plant is put into operation not later than 28 December 2004;
7. "nominal capacity" means the sum of the incineration capacities of the furnaces of which an incineration plant is composed, as specified by the constructor and confirmed by the operator, with due account being taken, in particular, of the calorific value of the waste, expressed as the quantity of waste incinerated per hour;
8. "emission" means the direct or indirect release of substances, vibrations, heat or noise from individual or diffuse sources in the plant into the air, water or soil;
9. "emission limit values" means the mass, expressed in terms of certain specific parameters, concentration and/or level of an emission, which may not be exceeded during one or more periods of time;
10. "dioxins and furans" means all polychlorinated dibenzo-p-dioxins and dibenzofurans listed in Annex I;
11. "operator" means any natural or legal person who operates or controls the plant or, where this is provided for in national legislation, to whom decisive economic power over the technical functioning of the plant has been delegated;
12. "permit" means a written decision (or several such decisions) delivered by the competent authority granting authorisation to operate a plant, subject to certain conditions which guarantee that the plant complies with all the requirements of this Directive. A permit may cover one or more plants or parts of a plant on the same site operated by the same operator;
13. "residue" means any liquid or solid material (including bottom ash and slag, fly ash and boiler dust, solid reaction products from gas treatment, sewage sludge from the treatment of waste waters, spent catalysts and spent activated carbon) defined as waste in Article 1(a) of Directive 75/442/EEC, which is generated by the incineration or co-incineration process, the exhaust gas or waste water treatment or other processes within the incineration or co-incineration plant.
Article 4
Application and permit
1. Without prejudice to Article 11 of Directive 75/442/EEC or to Article 3 of Directive 91/689/EEC, no incineration or co-incineration plant shall operate without a permit to carry out these activities.
2. Without prejudice to Directive 96/61/EC, the application for a permit for an incineration or co-incineration plant to the competent authority shall include a description of the measures which are envisaged to guarantee that:
(a) the plant is designed, equipped and will be operated in such a manner that the requirements of this Directive are taking into account the categories of waste to be incinerated;
(b) the heat generated during the incineration and co-incineration process is recovered as far as practicable e.g. through combined heat and power, the generating of process steam or district heating;
(c) the residues will be minimised in their amount and harmfulness and recycled where appropriate;
(d) the disposal of the residues which cannot be prevented, reduced or recycled will be carried out in conformity with national and Community legislation.
3. The permit shall be granted only if the application shows that the proposed measurement techniques for emissions into the air comply with Annex III and, as regards water, comply with Annex III paragraphs 1 and 2.
4. The permit granted by the competent authority for an incineration or co-incineration plant shall, in addition to complying with any applicable requirement laid down in Directives 91/271/EEC, 96/61/EC, 96/62/EC, 76/464/EEC and 1999/31/EC:
(a) list explicitly the categories of waste which may be treated. The list shall use at least the categories of waste set up in the European Waste Catalogue (EWC), if possible, and contain information on the quantity of waste, where appropriate;
(b) include the total waste incinerating or co-incinerating capacity of the plant;
(c) specify the sampling and measurement procedures used to satisfy the obligations imposed for periodic measurements of each air and water pollutants.
5. The permit granted by the competent authority to an incineration or co-incineration plant using hazardous waste shall in addition to paragraph 4:
(a) list the quantities of the different categories of hazardous waste which may be treated;
(b) specify the minimum and maximum mass flows of those hazardous wastes, their lowest and maximum calorific values and their maximum contents of pollutants, e.g. PCB, PCP, chlorine, fluorine, sulphur, heavy metals.
6. Without prejudice to the provisions of the Treaty, Member States may list the categories of waste to be mentioned in the permit which can be co-incinerated in defined categories of co-incineration plants.
7. Without prejudice to Directive 96/61/EC, the competent authority shall periodically reconsider and, where necessary, update permit conditions.
8. Where the operator of an incineration or co-incineration plant for non-hazardous waste is envisaging a change of operation which would involve the incineration or co-incineration of hazardous waste, this shall be regarded as a substantial change within the meaning of Article 2(10)(b) of Directive 96/61/EC and Article 12(2) of that Directive shall apply.
9. If an incineration or co-incineration plant does not comply with the conditions of the permit, in particular with the emission limit values for air and water, the competent authority shall take action to enforce compliance.
Article 5
Delivery and reception of waste
1. The operator of the incineration or co-incineration plant shall take all necessary precautions concerning the delivery and reception of waste in order to prevent or to limit as far as practicable negative effects on the environment, in particular the pollution of air, soil, surface water and groundwater as well as odours and noise, and direct risks to human health. These measures shall meet at least the requirements set out in paragraphs 3 and 4.
2. The operator shall determine the mass of each category of waste, if possible according to the EWC, prior to accepting the waste at the incineration or co-incineration plant.
3. Prior to accepting hazardous waste at the incineration or co-incineration plant, the operator shall have available information about the waste for the purpose of verifying, inter alia, compliance with the permit requirements specified in Article 4(5). This information shall cover:
(a) all the administrative information on the generating process contained in the documents mentioned in paragraph 4(a);
(b) the physical, and as far as practicable, chemical composition of the waste and all other information necessary to evaluate its suitability for the intended incineration process;
(c) the hazardous characteristics of the waste, the substances with which it cannot be mixed, and the precautions to be taken in handling the waste.
4. Prior to accepting hazardous waste at the incineration or co-incineration plant, at least the following reception procedures shall be carried out by the operator:
(a) the checking of those documents required by Directive 91/689/EEC and, where applicable, those required by Council Regulation (EEC) No 259/93 of 1 February 1993 on the supervision, and control of shipments of waste within, into and out of the European Community(23) and by dangerous-goods transport regulations;
(b) the taking of representative samples, unless inappropriate, e.g. for infectious clinical waste, as far as possible before unloading, to verify conformity with the information provided for in paragraph 3 by carrying out controls and to enable the competent authorities to identify the nature of the wastes treated. These samples shall be kept for at least one month after the incineration.
5. The competent authorities may grant exemptions from paragraphs 2, 3 and 4 for industrial plants and undertakings incinerating or co-incinerating only their own waste at the place of generation of the waste provided that the requirements of this Directive are met.
Article 6
Operating conditions
1. Incineration plants shall be operated in order to achieve a level of incineration such that the slag and bottom ashes Total Organic Carbon (TOC) content is less than 3 % or their loss on ignition is less than 5 % of the dry weight of the material. If necessary appropriate techniques of waste pretreatment shall be used.
Incineration plants shall be designed, equipped, built and operated in such a way that the gas resulting from the process is raised, after the last injection of combustion air, in a controlled and homogeneous fashion and even under the most unfavourable conditions, to a temperature of 850 °C, as measured near the inner wall or at another representative point of the combustion chamber as authorised by the competent authority, for two seconds. If hazardous wastes with a content of more than 1 % of halogenated organic substances, expressed as chlorine, are incinerated, the temperature has to be raised to 1100 °C for at least two seconds.
Each line of the incineration plant shall be equipped with at least one auxiliary burner. This burner must be switched on automatically when the temperature of the combustion gases after the last injection of combustion air falls below 850 °C or 1100 °C as the case may be. It shall also be used during plant start-up and shut-down operations in order to ensure that the temperature of 850 °C or 1100 °C as the case may be is maintained at all times during these operations and as long as unburned waste is in the combustion chamber.
During start-up and shut-down or when the temperature of the combustion gas falls below 850 °C or 1100 °C as the case may be, the auxiliary burner shall not be fed with fuels which can cause higher emissions than those resulting from the burning of gasoil as defined in Article 1(1) of Council Directive 75/716/EEC, liquefied gas or natural gas.
2. Co-incineration plants shall be designed, equipped, built and operated in such a way that the gas resulting from the co-incineration of waste is raised in a controlled and homogeneous fashion and even under the most unfavourable conditions, to a temperature of 850 °C for two seconds. If hazardous wastes with a content of more than 1 % of halogenated organic substances, expressed as chlorine, are co-incinerated, the temperature has to be raised to 1100 °C.
3. Incineration and co-incineration plants shall have and operate an automatic system to prevent waste feed:
(a) at start-up, until the temperature of 850 °C or 1100 °C as the case may be or the temperature specified according to paragraph 4 has been reached;
(b) whenever the temperature of 850 °C or 1100 °C as the case may be or the temperature specified according to paragraph 4 is not maintained;
(c) whenever the continuous measurements required by this Directive show that any emission limit value is exceeded due to disturbances or failures of the purification devices.
4. Conditions different from those laid down in paragraph 1 and, as regards the temperature, paragraph 3 and specified in the permit for certain categories of waste or for certain thermal processes may be authorised by the competent authority, provided the requirements of this Directive are met. Member States may lay down rules governing these authorisations. The change of the operational conditions shall not cause more residues or residues with a higher content of organic pollutants compared to those residues which could be expected under the conditions laid down in paragraph 1.
Conditions different from those laid down in paragraph 2 and, as regards the temperature, paragraph 3 and specified in the permit for certain categories of waste or for certain thermal processes may be authorised by the competent authority, provided the requirements of this Directive are met. Member States may lay down rules governing these authorisations. Such authorisation shall be conditional upon at least the provisions for emission limit values set out in Annex V for total organic carbon and CO being complied with.
In the case of co-incineration of their own waste at the place of its production in existing bark boilers within the pulp and paper industry, such authorisation shall be conditional upon at least the provisions for emission limit values set out in Annex V for total organic carbon being complied with.
All operating conditions determined under this paragraph and the results of verifications made shall be communicated by the Member State to the Commission as part of the information provided in accordance with the reporting requirements.
5. Incineration and co-incineration plants shall be designed, equipped, built and operated in such a way as to prevent emissions into the air giving rise to significant ground-level air pollution; in particular, exhaust gases shall be discharged in a controlled fashion and in conformity with relevant Community air quality standards by means of a stack the height of which is calculated in such a way as to safeguard human health and the environment.
6. Any heat generated by the incineration or the co-incineration process shall be recovered as far as practicable.
7. Infectious clinical waste should be placed straight in the furnace, without first being mixed with other categories of waste and without direct handling.
8. The management of the incineration or the co-incineration plant shall be in the hands of a natural person who is competent to manage the plant.
Article 7
Air emission limit values
1. Incineration plants shall be designed, equipped, built and operated in such a way that the emission limit values set out in Annex V are not exceeded in the exhaust gas.
2. Co-incineration plants shall be designed, equipped, built and operated in such a way that the emission limit values determined according to or set out in Annex II are not exceeded in the exhaust gas.
If in a co-incineration plant more than 40 % of the resulting heat release comes from hazardous waste, the emission limit values set out in Annex V shall apply.
3. The results of the measurements made to verify compliance with the emission limit values shall be standardised with respect to the conditions laid down in Article 11.
4. In the case of co-incineration of untreated mixed municipal waste, the limit values will be determined according to Annex V, and Annex II will not apply.
5. Without prejudice to the provisions of the Treaty, Member States may set emission limit values for polycyclic aromatic hydrocarbons or other pollutants.
Article 8
Water discharges from the cleaning of exhaust gases
1. Waste water from the cleaning of exhaust gases discharged from an incineration or co-incineration plant shall be subject to a permit granted by the competent authorities.
2. Discharges to the aquatic environment of waste water resulting from the cleaning of exhaust gases shall be limited as far as practicable, at least in accordance with the emission limit values set in Annex IV.
3. Subject to a specific provision in the permit, the waste water from the cleaning of exhaust gases may be discharged to the aquatic environment after separate treatment on condition that:
(a) the requirements of relevant Community, national and local provisions are complied with in the form of emission limit values; and
(b) the mass concentrations of the polluting substances referred to in Annex IV do not exceed the emission limit values laid down therein.
4. The emission limit values shall apply at the point where waste waters from the cleaning of exhaust gases containing the polluting substances referred to in Annex IV are discharged from the incineration or co-incineration plant.
Where the waste water from the cleaning of exhaust gases is treated on site collectively with other on-site sources of waste water, the operator shall take the measurements referred to in Article 11:
(a) on the waste water stream from the exhaust gas cleaning processes prior to its input into the collective waste water treatment plant;
(b) on the other waste water stream or streams prior to its or their input into the collective waste water treatment plant;
(c) at the point of final waste water discharge, after the treatment, from the incineration plant or co-incineration plant.
The operator shall take appropriate mass balance calculations in order to determine the emission levels in the final waste water discharge that can be attributed to the waste water arising from the cleaning of exhaust gases in order to check compliance with the emission limit values set out in Annex IV for the waste water stream from the exhaust gas cleaning process.
Under no circumstances shall dilution of waste water take place for the purpose of complying with the emission limit values set in Annex IV.
5. When waste waters from the cleaning of exhaust gases containing the polluting substances referred to in Annex IV are treated outside the incineration or co-incineration plant at a treatment plant intended only for the treatment of this sort of waste water, the emission limit values of Annex IV are to be applied at the point where the waste waters leave the treatment plant. If this off-site treatment plant is not only dedicated to treat waste water from incineration, the operator shall take the appropriate mass balance calculations, as provided for under paragraph 4(a), (b) and (c), in order to determine the emission levels in the final waste water discharge that can be attributed to the waste water arising from the cleaning of exhaust gases in order to check compliance with the emission limit values set out in Annex IV for the waste water stream from the exhaust gas cleaning process.
Under no circumstances shall dilution of waste water take place for the purpose of complying with the emission limit values set in Annex IV.
6. The permit shall:
(a) establish emission limit values for the polluting substances referred to in Annex IV, in accordance with paragraph 2 and in order to meet the requirements referred to in paragraph 3(a);
(b) set operational control parameters for waste water at least for pH, temperature and flow.
7. Incineration and co-incineration plant sites, including associated storage areas for wastes, shall be designed and in such a way as to prevent the unauthorised and accidental release of any polluting substances into soil, surface water and groundwater in accordance with the provisions provided for in relevant Community legislation. Moreover, storage capacity shall be provided for contaminated rainwater run-off from the incineration or co-incineration plant site or for contaminated water arising from spillage or fire-fighting operations.
The storage capacity shall be adequate to ensure that such waters can be tested and treated before discharge where necessary.
8. Without prejudice to the provisions of the Treaty, Member States may set emission limit values for polycyclic aromatic hydrocarbons or other pollutants.
Article 9
Residues
Residues resulting from the operation of the incineration or co-incineration plant shall be minimised in their amount and harmfulness. Residues shall be recycled, where appropriate, directly in the plant or outside in accordance with relevant Community legislation.
Transport and intermediate storage of dry residues in the form of dust, such as boiler dust and dry residues from the treatment of combustion gases, shall take place in such a way as to prevent dispersal in the environment e.g. in closed containers.
Prior to determining the routes for the disposal or recycling of the residues from incineration and co-incineration plants, appropriate tests shall be carried out to establish the physical and chemical characteristics and the polluting potential of the different incineration residues. The analysis shall concern the total soluble fraction and heavy metals soluble fraction.
Article 10
Control and monitoring
1. Measurement equipment shall be installed and techniques used in order to monitor the parameters, conditions and mass concentrations relevant to the incineration or co-incineration process.
2. The measurement requirements shall be laid down in the permit or in the conditions attached to the permit issued by the competent authority.
3. The appropriate installation and the functioning of the automated monitoring equipment for emissions into air and water shall be subject to control and to an annual surveillance test. Calibration has to be done by means of parallel measurements with the reference methods at least every three years.
4. The location of the sampling or measurement points shall be laid down by the competent authority.
5. Periodic measurements of the emissions into the air and water shall be carried out in accordance with Annex III, points 1 and 2.
Article 11
Measurement requirements
1. Member States shall, either by specification in the conditions of the permit or by general binding rules, ensure that paragraphs 2 to 12 and 17, as regards air, and paragraphs 9 and 14 to 17, as regards water, are complied with.
2. The following measurements of air pollutants shall be carried out in accordance with Annex III at the incineration and co-incineration plant:
(a) continuous measurements of the following substances: NOx, provided that emission limit values are set, CO, total dust, TOC, HCl, HF, SO2;
(b) continuous measurements of the following process operation parameters: temperature near the inner wall or at another representative point of the combustion chamber as authorised by the competent authority, concentration of oxygen, pressure, temperature and water vapour content of the exhaust gas;
(c) at least two measurements per year of heavy metals, dioxins and furans; one measurement at least every three months shall however be carried out for the first 12 months of operation. Member States may fix measurement periods where they have set emission limit values for polycyclic aromatic hydrocarbons or other pollutants.
3. The residence time as well as the minimum temperature and the oxygen content of the exhaust gases shall be subject to appropriate verification, at least once when the incineration or co-incineration plant is brought into service and under the most unfavourable operating conditions anticipated.
4. The continuous measurement of HF may be omitted if treatment stages for HCl are used which ensure that the emission limit value for HCl is not being exceeded. In this case the emissions of HF shall be subject to periodic measurements as laid down in paragraph 2(c).
5. The continuous measurement of the water vapour content shall not be required if the sampled exhaust gas is dried before the emissions are analysed.
6. Periodic measurements as laid down in paragraph 2(c) of HCl, HF and SO2 instead of continuous measuring may be authorised in the permit by the competent authority in incineration or co-incineration plants, if the operator can prove that the emissions of those pollutants can under no circumstances be higher than the prescribed emission limit values.
7. The reduction of the frequency of the periodic measurements for heavy metals from twice a year to once every two years and for dioxins and furans from twice a year to once every year may be authorised in the permit by the competent authority provided that the emissions resulting from co-incineration or incineration are below 50 % of the emission limit values determined according to Annex II or Annex V respectively and provided that criteria for the requirements to be met, developed in accordance with the procedure laid down in Article 17, are available. These criteria shall at least be based on the provisions of the second subparagraph, points (a) and (d).
Until 1 January 2005 the reduction of the frequency may be authorised even if no such criteria are available provided that:
(a) the waste to be co-incinerated or incinerated consists only of certain sorted combustible fractions of non-hazardous waste not suitable for recycling and presenting certain characteristics, and which is further specified on the basis of the assessment referred to in subparagraph (d);
(b) national quality criteria, which have been reported to the Commission, are available for these wastes;
(c) co-incineration and incineration of these wastes is in line with the relevant waste management plans referred to in Article 7 of Directive 75/442/EEC;
(d) the operator can prove to the competent authority that the emissions are under all circumstances significantly below the emission limit values set out in Annex II or Annex V for heavy metals, dioxins and furans; this assessment shall be based on information on the quality of the waste concerned and measurements of the emissions of the said pollutants;
(e) the quality criteria and the new period for the periodic measurements are specified in the permit; and
(f) all decisions on the frequency of measurements referred to in this paragraph, supplemented with information on the amount and quality of the waste concerned, shall be communicated on a yearly basis to the Commission.
8. The results of the measurements made to verify compliance with the emission limit values shall be standardised at the following conditions and for oxygen according to the formula as referred to in Annex VI:
(a) Temperature 273 K, pressure 101,3 kPa, 11 % oxygen, dry gas, in exhaust gas of incineration plants;
(b) Temperature 273 K, pressure 101,3 kPa, 3 % oxygen, dry gas, in exhaust gas of incineration of waste oil as defined in Directive 75/439/EEC;
(c) when the wastes are incinerated or co-incinerated in an oxygen-enriched atmosphere, the results of the measurements can be standardised at an oxygen content laid down by the competent authority reflecting the special circumstances of the individual case;
(d) in the case of co-incineration, the results of the measurements shall be standardised at a total oxygen content as calculated in Annex II.
When the emissions of pollutants are reduced by exhaust gas treatment in an incineration or co-incineration plant treating hazardous waste, the standardisation with respect to the oxygen contents provided for in the first subparagraph shall be done only if the oxygen content measured over the same period as for the pollutant concerned exceeds the relevant standard oxygen content.
9. All measurement results shall be recorded, processed and presented in an appropriate fashion in order to enable the competent authorities to verify compliance with the permitted operating conditions and emission limit values laid down in this Directive in accordance with procedures to be decided upon by those authorities.
10. The emission limit values for air shall be regarded as being complied with if:
(a) - none of the daily average values exceeds any of the emission limit values set out in Annex V(a) or Annex II;
- 97 % of the daily average value over the year does not exceed the emission limit value set out in Annex V(e) first indent;
(b) either none of the half-hourly average values exceeds any of the emission limit values set out in Annex V(b), column A or, where relevant, 97 % of the half-hourly average values over the year do not exceed any of the emission limit values set out in Annex V(b), column B;
(c) none of the average values over the sample period set out for heavy metals and dioxins and furans exceeds the emission limit values set out in Annex V(c) and (d) or Annex II;
(d) the provisions of Annex V(e), second indent or Annex II, are met.
11. The half-hourly average values and the 10-minute averages shall be determined within the effective operating time (excluding the start-up and shut-off periods if no waste is being incinerated) from the measured values after having subtracted the value of the confidence interval specified in point 3 of Annex III. The daily average values shall be determined from those validated average values.
To obtain a valid daily average value no more than five half-hourly average values in any day shall be discarded due to malfunction or maintenance of the continuous measurement system. No more than ten daily average values per year shall be discarded due to malfunction or maintenance of the continuous measurement system.
12. The average values over the sample period and the average values in the case of periodical measurements of HF, HCl and SO2 shall be determined in accordance with the requirements of Article 10(2) and (4) and Annex III.
13. The Commission, acting in accordance with the procedure laid down in Article 17, shall decide, as soon as appropriate measurement techniques are available within the Community, the date from which continuous measurements of the air emission limit values for heavy metals, dioxins and furans shall be carried out in accordance with Annex III.
14. The following measurements shall be carried out at the point of waste water discharge:
(a) continuous measurements of the parameters referred to in Article 8(6)(b);
(b) spot sample daily measurements of total suspended solids; Member States may alternatively provide for measurements of a flow proportional representative sample over a period of 24 hours;
(c) at least monthly measurements of a flow proportional representative sample of the discharge over a period of 24 hours of the polluting substances referred to in Article 8(3) with respect to items 2 to 10 in Annex IV;
(d) at least every six months measurements of dioxins and furans; however one measurement at least every three months shall be carried out for the first 12 months of operation. Member States may fix measurement periods where they have set emission limit values for polycyclic aromatic hydrocarbons or other pollutants.
15. The monitoring of the mass of pollutants in the treated waste water shall be done in conformity with Community legislation and laid down in the permit as well as the frequency of the measurements.
16. The emission limit values for water shall be regarded as being complied with if:
(a) for total suspended solids (polluting substance number 1), 95 % and 100 % of the measured values do not exceed the respective emission limit values as set out in Annex IV;
(b) for heavy metals (polluting substances number 2 to 10) no more than one measurement per year exceeds the emission limit values set out in Annex IV; or, if the Member State provides for more than 20 samples per year, no more than 5 % of these samples exceed the emission limit values set out in Annex IV;
(c) for dioxins and furans (polluting substance 11), the twice-yearly measurements do not exceed the emission limit value set out in Annex IV.
17. Should the measurements taken show that the emission limit values for air or water laid down in this Directive have been exceeded, the competent authorities shall be informed without delay.
Article 12
Access to information and public participation
1. Without prejudice to Council Directive 90/313/EEC(24) and Directive 96/61/EC, applications for new permits for incineration and co-incineration plants shall be made available at one or more locations accessible to the public, such as local authority offices, for an appropriate period to enable it to comment on them before the competent authority reaches a decision. That decision, including at least a copy of the permit, and any subsequent updates, shall also be made available to the public.
2. For incineration or co-incineration plants with a nominal capacity of two tonnes or more per hour and notwithstanding Article 15(2) of Directive 96/61/EC, an annual report to be provided by the operator to the competent authority on the functioning and monitoring of the plant shall be made available to the public. This report shall, as a minimum requirement, give an account of the running of the process and the emissions into air and water compared with the emission standards in this Directive. A list of incineration or co-incineration plants with a nominal capacity of less than two tonnes per hour shall be drawn up by the competent authority and shall be made available to the public.
Article 13
Abnormal operating conditions
1. The competent authority shall lay down in the permit the maximum permissible period of any technically unavoidable stoppages, disturbances, or failures of the purification devices or the measurement devices, during which the concentrations in the discharges into the air and the purified waste water of the regulated substances may exceed the prescribed emission limit values.
2. In the case of a breakdown, the operator shall reduce or close down operations as soon as practicable until normal operations can be restored.
3. Without prejudice to Article 6(3)(c), the incineration plant or co-incineration plant or incineration line shall under no circumstances continue to incinerate waste for a period of more than four hours uninterrupted where emission limit values are exceeded; moreover, the cumulative duration of operation in such conditions over one year shall be less than 60 hours. The 60-hour duration applies to those lines of the entire plant which are linked to one single flue gas cleaning device.
4. The total dust content of the emissions into the air of an incineration plant shall under no circumstances exceed 150 mg/m3 expressed as a half-hourly average; moreover the air emission limit values for CO and TOC shall not be exceeded. All other conditions referred to in Article 6 shall be complied with.
Article 14
Review clause
Without prejudice to Directive 96/61/EC, the Commission shall submit a report to the European Parliament and the Council before 31 December 2008 based on experience of the application of this Directive, in particular for new plants, and on the progress achieved in emission control techniques and experience in waste management. Furthermore, the report shall be based on the development of the state of technology, of experience in the operation of the plants, of environmental requirements. This report will include a specific section on the application of Annex II.1.1. and in particular on the economic and technical feasibility for existing cement kilns as referred to in the footnote to Annex II.1.1. of respecting the NOx emission limit value for new cement kilns set out in that Annex. The report shall, as appropriate, be accompanied by proposals for revision of the related provisions of this Directive. However, the Commission shall, if appropriate, propose an amendment for Annex II.3 before the said report, if major waste streams are directed to types of co-incineration plants other than those dealt with in Annex II.1 and II.2.
Article 15
Reporting
The reports on the implementation of this Directive shall be established in accordance with the procedure laid down in Article 5 of Council Directive 91/692/EEC. The first report shall cover at least the first full three-year period after 28 December 2002 and comply with the periods referred to in Article 17 of Directive 94/67/EC and in Article 16(3) of Directive 96/61/EC. To this effect, the Commission shall elaborate the appropriate questionnaire in due time.
Article 16
Future adaptation of the directive
The Commission shall, in accordance with the procedure laid down in Article 17(2), amend Articles 10, 11 and 13 and Annexes I and III in order to adapt them to technical progress or new findings concerning the health benefits of emission reductions.
Article 17
Regulatory committee
1. The Commission shall be assisted by a regulatory committee.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The committee shall adopt its own rules of procedure.
Article 18
Repeal
The following shall be repealed as from 28 December 2005:
(a) Article 8(1) and the Annex to Directive 75/439/EEC;
(b) Directive 89/369/EEC;
(c) Directive 89/429/EEC;
(d) Directive 94/67/EC.
Article 19
Penalties
The Member States shall determine penalties applicable to breaches of the national provisions adopted pursuant to this Directive. The penalties thus provided for shall be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by 28 December 2002 at the latest and shall notify it without delay of any subsequent amendment affecting them.
Article 20
Transitional provisions
1. Without prejudice to the specific transitional provisions provided for in the Annexes to this Directive, the provisions of this Directive shall apply to existing plants as from 28 December 2005.
2. For new plants, i.e. plants not falling under the definition of "existing incineration or co-incineration plant" in Article 3(6) or paragraph 3 of this Article, this Directive, instead of the Directives mentioned in Article 18, shall apply as from 28 December 2002.
3. Stationary or mobile plants whose purpose is the generation of energy or production of material products and which are in operation and have a permit in accordance with existing Community legislation where required and which start co-incinerating waste not later than 28 December 2004 are to be regarded as existing co-incineration plants.
Article 21
Implementation
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 28 December 2002. They shall forthwith inform the Commission thereof.
When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the text of the provisions of domestic law which they adopt in the field governed by this Directive.
Article 22
Entry into force
This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.
Article 23
Addressees
This Directive is addressed to the Member States.
|
[
"UKSI20022980"
] |
32000L0081
|
2000
|
Commission Directive 2000/81/EC of 18 December 2000 amending the Annexes to Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables, respectively (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(1), as last amended by Directive 2000/58/EC(2), and in particular Article 10 thereof,
Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin(3), as last amended by Directive 2000/58/EC, and in particular Article 10 thereof,
Having regard to Council Directive 90/642/EEC of 27 November 1990 on fixing of maximum levels for pesticide residues in and on certain products of plant origin including fruit and vegetables(4), as last amended by Directive 2000/58/EC, and in particular Article 7 thereof,
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(5), as last amended by Commission Directive 2000/68/EC(6), and in particular Article 4(1)(f) thereof,
Whereas:
(1) The new active substance, spiroxamine, was included in Annex I to Directive 91/414/EEC by Commission Directive 1999/73/EC(7) for use as fungicide only, without specifying particular conditions having an impact on crops which may be treated with plant protection products containing spiroxamine.
(2) The said inclusion in Annex I was based on assessment of the information submitted concerning proposed use as fungicide on cereals and vines. Information relating to uses on cereals and vines has been submitted by certain Member States in accordance with the requirements of Article 4(1)(f) of Directive 91/414/EEC. The information available has been reviewed and is sufficient to fix certain maximum residue levels.
(3) Where no Community maximum residue level or provisional MRL exists Member States shall establish a national provisional maximum residue level in accordance with Article 4(1)(f) of Directive 91/414/EEC before the authorisation may be granted.
(4) At the inclusion in Annex I to Directive 91/414/EEC the technical and scientific evaluation of spiroxamine has been finalised on 12 May 1999 in the format of the Commission review report for spiroxamine. In this review report the acceptable daily intake (ADI) for spiroxamine was set at 0,025 mg/kg bw/day. The lifetime exposure of consumers of food products treated with spiroxamine has been assessed and evaluated in accordance with the procedures and practices used within the European Community, taking account of guidelines published by the World Health Organisation(8) and it has been calculated that the maximum residue levels fixed in this Directive do not give rise to an exceedence of this ADI.
(5) Acute toxic effects requiring the setting of an acute reference dose were not noted during the evaluation and discussion that preceded the inclusion of spiroxamine in Annex I to Directive 91/414/EEC.
(6) For certain agricultural products the use conditions for spiroxamine were already defined in a manner which permits the establishing of definitive maximum residue levels.
(7) To ensure that the consumer is adequately protected from exposure to residues in or on products for which no authorisations have been granted, it is prudent to set provisional maximum residue levels at the lower limit of analytical determination for all those products covered by Council Directives 86/362/EEC, 86/363/EEC and 90/642/EEC. The setting at Community level of such provisional maximum residue levels does not prevent the Member States from establishing provisional maximum residue levels for spiroxamine in accordance with Article 4(1)(f) of Directive 91/414/EEC, and in accordance with Annex VI to Directive 91/414/EEC, in particular part B, section 2.4.2.3 of this Annex; four years is considered a sufficient period of time during which to establish most further uses of spiroxamine. After that period these provisional maximum residue levels should become definitive.
(8) The Community notified the draft Commission Directive to the World Trade Organisation and the comments received have been considered in finalising the Directive. The possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the Commission on the basis of the submission of acceptable data.
(9) The opinions of the Scientific Committee for Plants, in particular advice and recommendations concerning the protection of consumers of food products treated with pesticides, have been taken into account.
(10) This Directive is in accordance with the opinion of the Standing Committee on Plant Health,
Article 1
The following shall be added to part A of Annex II to Directive 86/362/EEC:
">TABLE>"
Article 2
The following shall be added to part B of Annex II to Directive 86/363/EEC:
">TABLE>"
Article 3
The contents of the Annex to this Directive shall be added to Annex II to Directive 90/642/EEC.
Article 4
1. For those agricultural products listed in Annex II to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC where the maximum residue levels for spiroxamine are indicated as "(p)", this shall mean that they are provisional (p) in accordance with the provisions of Article 4(1)(f) of Directive 91/414/EEC.
2. Four years after the entry into force of this Directive, provisional maximum residue levels for spiroxamine in the Annexes shall cease to be provisional and shall become definitive in the sense of Article 4(1) of Directives 86/362/EEC and 86/363/EEC or Article 3 of Directive 90/642/EEC respectively.
Article 5
1. This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.
2. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 July 2001 at the latest. They shall forthwith inform the Commission thereof.
3. When Member Sates adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 6
This Directive is addressed to the Member States.
|
[
"UKSI20012420"
] |
32000L0082
|
2000
|
Commission Directive 2000/82/EC of 20 December 2000 amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC on the fixing of maximum levels for pesticide residues in and on fruit and vegetables, cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables respectively (Text with EEA relevance)
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables(1), as last amended by Commission Directive 2000/57/EC(2), and in particular Article 5 thereof,
Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals(3), as last amended by Commission Directive 2000/81/EC(4) and in particular Article 10 thereof,
Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin(5), as last amended by Directive 2000/81/EC, and in particular Article 10 thereof,
Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on products of plant origin, including fruit and vegetables(6), as last amended by Directive 2000/81/EC, and in particular Article 7 thereof,
Whereas:
(1) For cereals and products of plant origin including fruit and vegetables, residue levels should reflect the use of minimum quantities of pesticides necessary to achieve effective protection of plants, applied in such a manner that the amount of residue is the smallest practicable and is toxicologically acceptable, in particular in view of the protection of the environment and in terms of estimated dietary intake by consumers. For foodstuffs of animal origin, residue levels should reflect the consumption by animals of cereals and products of plant origin treated with pesticides as well as, where relevant, the direct consequences of the use of veterinary medicines.
(2) Maximum residue levels for pesticides should be kept under review and the levels may be changed to take account of new information and data. Maximum residue levels (MRLs) should be fixed at the lower limit of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residue in or on the food product, or where there are no authorised uses, or where uses which have been authorised by Member States have not been supported by the necessary data, or where uses in third countries resulting in residues in or on food products which may enter into circulation in the Community market have not been supported with such necessary data.
(3) Commission Decisions have been taken not to include active substances in Annex I to Council Directive 91/414/EEC of 15 July 1991 on the placing of plant protection products on the marke(7), as last amended by Commission Directive 2000/80/CE(8), for azinphos-ethyl (Commission Decision 95/276/EC(9)), propham (Commission Decision 96/586/EC(10)), dinoterb (Commission Decision 98/269/EC(11)), DNOC (Commission Decision 1999/164/EC(12)), pyrazophos (Commission Decision 2000/233/EC(13)), monolinuron (Commission Decision 2000/234/EC(14)), and chlozolinate (Commission Decision 2000/626/EC(15)) and tecnazene (Commission Decision 2000/725/EC(16)). These Decisions provided that plant protection products containing these active substances shall no longer be authorised for use in the Community. It is therefore necessary to add all of the pesticide residues arising from use of these plant protection products to the Annexes to Directives 86/362/EEC, 86/363/EEC and 90/642/EEC to allow for proper surveillance and control of their uses and to protect the consumer. In order to allow legitimate expectations to be fulfilled for existing stocks of pesticides to be used, the Commission non-inclusion Decisions allowed a phasing-out period, and it is appropriate that MRLs premised on the notion that use of the substance concerned is not authorised in the Community should not apply until the end of the phasing-out period applying to that substance.
(4) Maximum residue levels have been fixed in relation to azinphos-ethyl for some commodities in Annex II to Directive 76/895/EEC, as amended by Commission Directive 82/528/EEC(17), but Member States were permitted to establish higher MRLs. To establish harmonised maximum levels of pesticide residues for azinphos-ethyl in and on fruit and vegetables at Community level it is necessary to include these MRLs instead in Directive 90/642/EEC. Further, they should be amended following the withdrawal of authorisations at Community level.
(5) Community maximum residue levels and the levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures. There are no Codex maximum residue limits set for azinphos-ethyl, dinoterb, DNOC, monolinuron, propham and chlozolinate. There is a limited number of Codex maximum residue limits for pyrazophos and tecnazene and these have been considered in the setting of the maximum residue levels fixed in this Directive. The Community notified the draft Commission Directive to the World Trade Organisation and the comments received have been considered in finalising the Directive. The possibility of fixing import tolerance maximum residue levels for specific pesticide/crop combinations will be examined by the European Community on the basis of the submission of acceptable data and of acceptable consumer intake assessments(18).
(6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,
Article 1
In Annex II to Directive 76/895/EEC the entries relating to azinphos-ethyl shall be deleted.
Article 2
In the table in Part A of Annex II to Directive 86/362/EEC entries in respect of the following pesticide residues shall be added:
>TABLE>
Article 3
Annex II to Directive 86/363/EEC is hereby amended as follows:
1. Entries in respect of the following pesticide residues shall be added to the table in part A:
>TABLE>
2. Entries in respect of the following pesticide residues shall be added to the table in The part B:
>TABLE>
Article 4
In the table in Annex II to Directive 90/642/EEC, the entries for pesticide residues as set out in the Annex to this Directive shall be added.
Article 5
1. This Directive shall enter into force 20 days after publication of this Directive.
2. Member States shall adopt and publish the legislative, regulatory or administrative measures to comply with this Directive by 1 July 2001. They shall immediately inform thereof the Commission.
3. They shall apply these measures as from 1 July 2001 for azinphos-ethyl, propham, and dinoterb.
4. They shall apply these measures as from 1 July 2002 for DNOC, pyrazophos, and monolinuron.
5. They shall apply these measures as from 1 January 2003 for chlozolinate and tecnazene.
6. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. Member States shall adopt the procedure for such reference.
Article 6
This Directive is addressed to the Member States.
|
[
"UKSI20012420"
] |
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