Feedingstuffs: additives

PURPOSE: amendment of Council Directive 70/524/EEC concerning additives in feedingstuffs. CONTENT: Council Directive 70/524/EEC concerning additives in feedingstuffs, as amended by Directive 96/51/EC, establishes for high technology additives with a very specific composition (antibiotics, coccidiostats and other medicinal substances, and growth promoters) a system where the authorisation will be linked to the person responsible for putting the additive into circulation, in order to protect for a period fixed at ten years, scientific data or information which require costly investment. It is provided for that the Commission replaces the existing authorisations by authorisations linked to a person responsible for putting the additive into circulation through the adoption of a Regulation. The purpose of the proposed amendment is to ensure that these replacements can take place at the same time for all additives concerned, independently of the date when their authorisation was granted. Currently, Directive 70/524/EEC foresees different treatment of high technolcogy additive depending on the date of authorisation. In contrast to those which were authorised after 31 December 1987, high technology additives which were authorised before that date have to undergo a reevaluation procedure. However, beyond that distinction, while the replacement of the authorisations granted after 31 December 1987 is foreseen for 1 October 1999, a legal basis for a replacement of the authorisations granted before 1 January 1988 is missing. Article 9g of the Directive provides only for a replacement after compeltion of the re-evaluation in 2003. Given this legal situation, the consequence would be that copies may remain in circulation after 1 October 1999, which have been evaluated according to standards lower than those which were applied to substances authorised more recently (after 31 December 1987). Moreover, this applies not only to substances but also to uses of substances, authorised sunsequently to those authorised at the first authorisation of the substance. Therefore, it may occur in many cases, that a copy may still be put in circulation because a certain use of the substance was authorised before 1988, while the authorisation of the same substance authorised subsequently for another use would be linked to a person responsible for putting it into circulation. This situation is not acceptable, is contrary to the intentions of the legislator and should be corrected. To re-establish a coherent legal situation, the Commission proposes to introduce a legal basis in Directive 70/524/EEC for the replacement of the authorisations of those additives authorised before 1 January 1988 already on 1 October 1999.�