Foodstuffs of animal origin: maximum residue limits of veterinary medicinal products

The Committee notes that the amendments in question concern various procedural aspects and deadlines. Each will be considered in detail. Given the urgency as a result of the legal void which has been created, the Committee has adopted an opinion on the procedural aspects and deadlines contained in the proposal, and will return to the substantial issues raised subsequently as soon as the Commission formulates new proposals. The need to update the procedure The Committee considers that the proposed amendments to Articles 7, 8, 10 and 12 are appropriate to the new legal framework for medicinal products and the Community's international obligations. The need to extend the deadline for the review of substances already in use Given the rate at which substances already in use are being examined, and the fact that over 200 remain to be dealt with, the Committee is obliged to approve the extension laid down in the first and second paragraph of Article 14. The Committee does not, however, consider two years to be sufficient, given the time required for in-depth examination, which is essential to consumer and animal health protection and if the practice of repeated extensions is not to continue. This is partly on the basis of the data gathered by the European Agency for the Evaluation of Medicinal Products. The Committee proposes that the deadline be set definitively for 1 January 2000, with no possibility of extension. Establishment of maximum residue limits for substances undergoing clinical trials Since the Committee considers that consumer protection is already provided at national level by the rules under Directive 93/40/EEC and by the good clinical practices laid down in Directive 92/18/EEC, it does not believe that establishing a provisional MRL will enhance consumer safety. Consequently, the Committee does not accept the addition of a new Article 4(a) or of the third paragraph of Article 14, and calls upon the Commission to draft a new proposal reflecting the CVMP guidelines so as to reconcile consumer safety with the need to avoid the destruction of animals used for trials wherever possible. �