Commission Regulation (EC) No 1742/96 of 6 September 1996 amending Annexes I, II and III of Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin
Commission Regulation (EC) No 1742/96of 6 September 1996amending Annexes I, II and III of Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal originOJ No L 224, 18. 8. 1990, p. 1., as last amended by Commission Regulation (EC) No 1433/96OJ No L 184, 24. 7. 1996, p. 21., and in particular Articles 6, 7 and 8 thereof,Whereas, in accordance with Regulation (EEC) No 2377/90, maximum residue limits must be established progressively for all pharmacologically active substances which are used within the Community in veterinary medicinal products intended for administration to food-producing animals;Whereas maximum residue limits should be established only after the examination within the Committee for Veterinary Medicinal Products of all the relevant information concerning the safety of residues of the substance concerned for the consumer of foodstuffs of animal origin and the impact of residues on the industrial processing of foodstuffs;Whereas, in establishing maximum residue limits for residues of veterinary medicinal products in foodstuffs of animal origin, it is necessary to specify the animal species in which residues may be present, the levels which may be present in each of the relevant meat tissues obtained from the treated animal (target tissue) and the nature of the residue which is relevant for the monitoring of residues (marker residue);Whereas, for the control of residues, as provided for in appropriate Community legislation, maximum residue limits should usually be established for the target tissues of liver or kidney, whereas, however, the liver and kidney are frequently removed from carcases moving in international trade, and maximum residue limits should therefore also always be established for muscle or fat tissues;Whereas, in the case of veterinary medicinal products intended for use in laying birds, lactating animals or honey bees, maximum residue limits must also be established for eggs, milk or honey;Whereas, amitraz (for porcine) should be inserted into Annex I to Regulation (EEC) No 2377/90;Whereas cetrimide, lobeline, pancreatin, chlorocresol, thymol and ketoprofen (for porcine) should be inserted into Annex II to Regulation (EEC) No 2377/90;Whereas, in order to allow for the completion of scientific studies, amitraz (for bovine and ovine) should be inserted into Annex III to Regulation (EEC) No 2377/90;Whereas a period of 60 days should be allowed before the entry into force of this Regulation in order to allow Member States to make any adjustment which may be necessary to the authorizations to place the veterinary medicinal products concerned on the market which have been granted in accordance with Council Directive 81/851/EECOJ No L 317, 6. 11. 1981, p. 1., as last amended by Commission Directive 93/40/EECOJ No L 214, 24. 8. 1993, p. 31., to take account of the provisions of this Regulation;Whereas the measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,HAS ADOPTED THE FOLLOWING REGULATION:
Article 1Annexes I, II and III of Regulation (EEC) No 2377/90 are hereby amended as set out in the Annex hereto.
Article 2This Regulation shall enter into force on the 60th day following its publication in the Official Journal of the European Communities.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 6 September 1996.For the CommissionMartin BangemannMember of the CommissionANNEXRegulation (EEC) No 2377/90 is modified as follows:A.Annex I is modified as follows:2.Anti-parasitic agents2.2.Agents acting against ecto-parasites2.2.2.Formamidines
Pharmacologically active substanceMarker residueAnimal speciesMRLsTarget tissuesOther provisions
"2.2.2.1.AmitrazSum of amitraz and all metabolites containing the 2,4-DMA moiety, expressed as amitrazPorcine400 μg/kgFat + skin
200 μg/kgLiver, kidney"
B.Annex II is modified as follows:2.Organic compounds
Pharmacologically active substance(s)Animal speciesOther provisions
"2.30KetoprofenPorcine
2.57CetrimideAll food producing species
2.58LobehneAll food producing species
2.59PancreatinAll mammalian food-producing speciesFor topical use only"
2.60ChlorocresolAll food producing species
2.61ThymolAll food producing species
C.Annex III is modified as follows:2.Anti-parasitic agents2.2.Agents acting against ecto-parasites2.2.1.Formamidines
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
"2.2.1.1.AmitrazSum of amitraz and all metabolites containing the 2,4-DMA moiety, expressed as amitrazBovine200 μg/kgLiver, kidney, fatProvisional MRLs expire on 1 July 1998"
10 μg/kgMilk
Ovine400 μg/kgFat
200 μg/kgLiver, kidney