Commission Regulation (EC) No 282/96 of 14 February 1996 amending Annexes I, II and III to 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 (Text with EEA relevance)
Commission Regulation (EC) No 282/96of 14 February 1996amending Annexes I, II and III to 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(Text with EEA relevance) 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 281/96See page 9 of this Official Journal., 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 cefquinome should be inserted into Annex I to Regulation (EEC) No 2377/90;Whereas buserelin, ketoprofen, caffeine, theophylline and theobromine should be inserted into Annex II to Regulation (EEC) No 2377/90;Whereas, in order to allow for the completion of scientific studies, josamycin, decoquinate and colistin 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 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 THIS REGULATION:
Article 1Annexes I, II and III to 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, 14 February 1996.For the CommissionMartin BangemannMember of the CommissionANNEXA.Annex I is amended as follows:1.Anti-infectious agents1.2.Antibiotics1.2.2.Cephalosporins
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
"1.2.2.1.CefquinomeCefquinomeBovine20 μg/kgMilk"
B.Annex II (2. "Organic compounds") is amended as follows:2.Organic chemicals
Pharmacologically active substance(s)Animal speciesOther provisions
"2.29.BuserelinAll food producing species
2.30.KetoprofenBovine, equidae
2.31.CaffeineAll food producing species
2.32.TheophyllineAll food producing species
2.33.TheobromineAll food producing species"
C.Annex III is amended as follows:1.Anti-infectious agents1.2.Antibiotics1.2.2Macrolides
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
"1.2.2.4.JosamycinJosamycinChicken400 μg/kgKidneyProvisional MRLs expire on 1 July 2000"
200 μg/kgLiver, muscle, fat
200 μg/kgEggs
1.2.6.Quinolones
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
"1.2.6.2.DecoquinateDecoquinateBovine, ovine500 μg/kgMuscle, liver, kidney, fatProvisional MRLs expire on 1 July 2000"
1.2.8.Polymyxins
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
"1.2.8.1.ColistinColistinBovine, ovine, porcine, chicken, rabbits200 μg/kgKidneyProvisional MRLs expire on 1 July 2000"
150 μg/kgLiver, muscle, fat
Bovine, ovine50 μg/kgMilk
Chicken300 μg/kgEggs