THE NEW CONCEPT FOR THE ESTABLISHMENT OF MAXIMUM RESIDUE LIMITS FOR FEED ADDITIVES IN ANIMAL DERIVED FOODSTUFFS AS PROPOSED BY THE EUROPEAN-COMMISSION

Beginning with January 1(st),1992 a system came into force in the Euro pean Union for the establishment of maximum residue limits (MRLs) for veterinary drug residues in animal derived food (Council Regulation No . 2377/90/EEC). The setting of MRLs involves the classification of vet erinary drugs according to their toxicological potency and/or the vali dity of the toxicological and analytical data available. Due to insuff icient toxicological information no safe MRLs could be established for a number of substances which, as a consequence, were recently prohibi ted in the European Union for administration to food producing animals . Among the substances banned are some which, paradoxically, are still approved for use as additives in feedstuffs (e. g. ipronidazol). In o rder to avoid contradictory drug regulations and to assure consumer sa fety, the European Commission initiated the elaboration of an amendmen t of Council Directive No. 87/153/EEC. The draft of the amended Commis sion Directive specifies for the first time a procedure for the establ ishment of MRLs for feed additives in animal derived food. It is based on the ADI-concept (Acceptable Daily Intake) and on standard food pac kages similar to those used for the safety assessment of veterinary dr ugs. This paper explains the principles underlying the establishment o f an ADI and the setting of MRLs for marker residues in target tissues and outlines the new specific requirements suggested for the safety e valuation of feed additives.