Proposal for a COUNCIL DIRECTIVE amending Directive 93/113/EC concerning the use and marketing of enzymes, micro-organisms and their preparations in animal nutrition
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 08. 01. 1997 COM(96) 715 final 97/0014 (CNS) Proposal for a COUNCIL DIRECTIVE amending Directive 93/113/EC concerning the use and marketing of enzymes, micro-organisms and their preparations in animal nutrition (presented by the Commission) EXPLANATORY MEMORANDUM On 14 December 1993 the Council adopted Directive 93/113/EC concerning the use and marketing of enzymes, micro-organisms and their preparations in animal nutrition. The measures concerned: authorize the Member States to permit provisionally the use on their territory of enzymes and micro-organisms appearing on their national lists before 1 November 1994, and apply Council Directive 70/524/EEC concerning additives in feedingstuffs (Community registration procedure, common rules on use and labelling) to the products in question. The timetable set by Directive 93/113/EC requires the Commission to decide before I January 1997 on the authorization applications that the Member States were obliged to send it, along with supporting evidence, before 1 January 1996 (the 2b Committee procedure). The Commission received 203 case files by that date, a list of which was published the European Communities No C 263 of II September 1996. in Official Journal of Eight meetings have so far been held and only half of the submitted files have been initially examined; it should be pointed out that neither the Member States nor the Commission expected to receive such a large number of authorization applications when Directive 93/113/EEC was adopted. In addition, it became obvious during appraisal that many of the files were incomplete and additional information would be required before a decision could be taken on the products that actually met the conditions laid down in Directive 70/524/EEC as regards safety of use and effectiveness for authorization as an additive. In view of the economic consequences for companies that an uncompromising rejection of incomplete files would entail, it was decided at the Meeting of the Standing Committee on Food Additives of 25 June 1996 to allow companies four months grace to complete their files (31 October 1996). Under the circumstances, it is impossible to decide on these applications for authorization by 1 January 1997 and it is proposed to postpone the date for one year. Proposal for a Council Directive of amending Directive 93/113/EC concerning the use and marketing of enzymes, micro-organisms and their preparations in animal nutrition 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 Commission1, Having regard to the opinion of the European Parliament2, Having regard to the opinion of the Economic and Social Committee3, Whereas Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs4, as last amended by Commission Directive 96/66/EC5, lays down the principles relating to the admission and the use of additives; Whereas Council Directive 93/113/EC of 14 December 1993 on the use and marketing of enzymes, micro-organisms and their preparations in animal nutrition6 authorizes the Member States to permit provisionally the use and marketing of the products in question provided that, on the basis of available scientific evidence, they do not present any danger to human or animal health; 1 OJNoC. 2O J N oC. 3O J N oC. 4O J N o L 2 7 0, 14. 12. 1970, p. 1. 5 OJ N* L 272, 25. 10. 19%, p. 32. 6 OJ No L 334, 31. 12. 1993, p. 17. Whereas Directive 93/113/EEC requires the Commission to decide before 1 January 1997 on case files submitted by the Member States before 1 January 1996 for the purpose of obtaining Community authorization under Directive 70/524/EEC; Whereas the large number of case files submitted by the Member States makes it impossible to decide, in full knowledge of the facts, on all the authorization applications by 31 December 1996; whereas the date by which the Commission must decide should thus be postponed by one year so that the Commission and the Member States have sufficient time to give serious consideration to the files submitted to them, HAS ADOPTED THIS DIRECTIVE: Article 1 The date of 1 January 1997 in Article 5 of Directive 93/113/EC is replaced by 1 January 1998. Article 2 This Directive shall enter into force on the seventh day following its publication in the Official Journal of the European Communities. Article 3 This Directive is addressed to the Member States Done at Brussels, For the Council ISSN 0254-1475 COM(96) 715 final DOCUMENTS EN 03 05 Catalogue number : CB-CO-96-729-EN-C ISBN 92-78-14091-0 Office for Official Publications of the European Communities L-2985 Luxembourg 4-