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COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 13.07.1998 COM(1998) 438 final 98/ 0237 (CNS) Proposal for a COUNCIL DIRECTIVE amending Directives 70/524/EEC concerning additives in feedingstuffs, 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 (presented by the Commission)

EXPLANATORY MEMORANDUM!f Amendment of Council Directive 70/524/EECi On 23 July 1996, the Council adopted Directive 96/51/EC amending Directive 70/524/EEC concerning additives in feedingstuffs 2. The Directive lays down provisions on the distribution and incorporation in feedingstuffs of additives and premixtures and the labelling of additives, premixtures and compound feedingstuffs which apply from 1 April 1998. 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 3 lays down a detailed timetable for the procedures for the approval and registration of such establishments and intermediaries. The date laid down for the adoption by the Member States of the amendments to Directive 70/524/EEC introduced by Directive 96/51 /EC (1 April 1998) is incompatible with the dates laid down by Directive 95/69/EC for the completion of the abovementioned approval procedures (1 April 2001) and registration procedures (1 September 1998). The proposed measures are intended to clarify the fact that the new rules on the distribution of additives, premixtures and compound feeduigstuffs, the incorporation in animal feedingstuffs of additives and premixtures and the labelling of additives, premixtures and compound feedingstuffs are applicable without prejudice to the time limits laid down by Directive 95/69/EC for the approval and registration of establishments and intermediaries by Member States. OJ L270, 14.12.1970, p. 1. Directive last amended by Commission Directive 98/19/EC (DJ L 96, 28.3.1998, p. 39). 2 3 OJL 235, 17.9.1996, p. 39. OJL 332, 30.12.1995, p. 15. i

II. Amendment of Council Directive 95/53/EC* Directive 95/53/EC sets out the principles governing the organisation of checks on products used in animal nutrition and lays down a list of Directives to which they apply. This list includes Directive 77/101/EEC 5, to be replaced by Directive 96/25/EC 6 from 1 July 1998. Directive 96/25/EC should therefore replace Directive 77/101/EEC in the list given in Directive 95/53/EC. III. Amendment of Council Directive 95/69/EC Directive 95/69/EC lays down that Member States must each year send the other Member States a list of approved establishments. It also lays down that the approval procedures for establishments must be completed by 1 April 2001. Member States clearly are not obliged to include in the abovementioned lists information on establishments in operation but still not approved. In the interests of transparency between Member States and with a view to official inspections in the field of animal nutrition, in particular on trade within the Community, the proposed measures lay down that the lists must also include information on establishment in operation but which have not yet received officiai approval. This proposal has no financial implications for the Community budget. It is based on an exclusive Community competence. 4 5 6 OJL 265,25.10.1995, p. 17. OJ L 32,3.2.1977, p. 1. Directive repealed by Directive 96/25/EC (OJ L 125,23.5.1996, p. 35). OJL 125,23.5.1996, p. 35.

Proposal for a COUNCIL DIRECTIVE of amending Directives 70/524/EEC concerning additives in feedingstuffs, 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 THE COUNCIL OF THE EUROPEAN UNION, 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, I laving regard to the opinion of the Economic and Social Committee*, Whereas Articles 13 to 16 of Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs 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; 1 ( ).i I. 1 o.i i. * (XI 1. 1 (XI 1,270, M.12.1970, p. I. Directive last amended by Commission Directive *)8/1Wl-C ((XI L %, 28.3.1W8, p. y)). s (XI I. 235, 17.0.19%, p. 3 l X V

Whereas the deadline of 1 April 1998 laid down for the adoption by the Member States of the amendments to Directive 70/524/EEC introduced by Directive 96/51/EC is incompatible with the dates laid down by 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 6 for the completion of approval procedures (1 April 2001) and registration procedures (1 September 1998); whereas the provisions concerned apply without prejudice to the deadlines laid down in Directive 95/69/EC; whereas Directive 70/524/EEC must nevertheless be amended for reasons of legal security; 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 7 must cover all products and substances used in animal feedingstuffs in the Community; Whereas, in order to achieve that objective, 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 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; * OJL 332,30.12.1995, p. 15. 7 8 9 OJL 265,25.10.1995, p. 17. OJL 125,23.5.1996,p. 35. OJ L 32,3.2.1977, p. 1. Directiverepealedby Directive 96/25/EC (OJ L 125,23.5.1996, p. 35). r

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 meantime, with a view to official inspections in the field of animal nutrition, in particular on trade within the Community, that 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, HAS ADOPTED THIS DIRECTIVE: Aûicie_I Directive 70/524/EEC is hereby amended as follows: 1. The following paragraph 6 is added to Article 13 : "6. Paragraphs 1 and 3 shall apply without prejudice to Articles 4(2) and 9(2) of Directive 95/69/EC." 2. The following Article 16a is inserted: "Alûcje_l â The provisions of 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 95/53/EC is hereby amended as follows: The third indent of Article 2(1 )(a) is 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 3 Directive 95/69/EC is hereby amended as follows: The second and third sentences of Article 6(2) are replaced by the following: "Before 31 December each year, Member States shall send 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 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 establishments referred to in Article 4(2) which have submitted applications for approval on which the Member States have not yet taken a decision." 1-

Article 4 1. By 30 June 1998, the Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately inform the Commission thereof. The measures adopted shall apply from 1 July 1998 and 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 a reference shall be adopted by Member States. 2. 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. Aûiclej; This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities. Ariicje_ This Directive is addressed to the Member States. Done at For the Council» The President t

ISSN 0254-1475 COM(98) 438 final DOCUMENTS EN 03 06 08 15 Catalogue number : CB-CO-98-449-EN-C ISBN 92-78-38067-9 Office for Official Publications of the European Communities L-2985 Luxembourg 9