Commission Regulation (EC) No 1838/97 of 24 September 1997 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 1838/97of 24 September 1997amending 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 L 224, 18. 8. 1990, p. 1., as last amended by Commission Regulation (EC) No 749/97OJ L 110, 26. 4. 1997, p. 24., 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, baquiloprim, tylosin and tolfenamic acid should be inserted into Annex I to Regulation (EEC) No 2377/90;Whereas bismuth subcarbonate, bismuth subgallate, bismuth subnitrate, bismuth subsalicylate, cloprostenol, r-cloprostenol and luprostiol should be inserted into Annex II to Regulation (EEC) No 2377/90;Whereas, in order to allow for the completion of scientific studies, apramycin 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 L 317, 6. 11. 1981, p. 1., as last amended by Directive 93/40/EECOJ 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, 24 September 1997.For the CommissionMartin BangemannMember of the CommissionANNEXThe Annexes to Regulation (EEC) No 2377/90 are hereby amended as follows:A.Annex I is amended as follows:1.Anti-infectious agents1.1.Chemotherapeutics1.1.2.Diamino pyrimidine derivates
Pharmacologically active substanceMarker residueAnimal speciesMRLsTarget tissuesOther provisions
"1.1.2.1.BaquiloprimBaquiloprimBovine10 μg/kgFat
300 μg/kgLiver
150 μg/kgKidney
30 μg/kgMilk
Porcine40 μg/kgSkin + fat
50 μg/kgLiver, kidney"
1.2.Antibiotics1.2.4.Macrolides
Pharmacologically active substanceMarker residueAnimal speciesMRLsTarget tissuesOther provisions
"1.2.4.3.TylosinTylosin ABovine100 μg/kgMuscle, fat, liver, kidney
50 μg/kgMilk
Porcine100 μg/kgMuscle, skin + fat, liver, kidney
Poultry100 μg/kgMuscle, skin + fat, liver, kidneyNot for use in hens producing eggs for human consumption"
4.Anti-inflammatory agents4.1.Nonsteroidal anti-inflammatory agents4.1.2.Fenamate group derivatives
Pharmacologically active substanceMarker residueAnimal speciesMRLsTarget tissuesOther provisions
"4.1.2.1.Tolfenamic acidTolfenamic acidBovine50 μg/kgMuscle
400 μg/kgLiver
100 μg/kgKidney
50 μg/kgMilk
Porcine50 μg/kgMuscle
400 μg/kgLiver
100 μg/kgKidney"
B.Annex II is amended as follows:1.Inorganic compounds
Pharmacologically active substance(s)Animal speciesOther provisions
"1.30.Bismuth subcarbonateAll food-producing speciesFor oral use only
1.31.Bismuth subgallateAll food-producing speciesFor oral use only
1.32.Bismuth subnitrateAll food-producing speciesFor oral use only
1.33.Bismuth subsalicylateAll food-producing speciesFor oral use only"
2.Organic compounds
Pharmacologically active substance(s)Animal speciesOther provisions
"2.79.CloprostenolBovine, porcine, equidae
2.80.R-CloprostenolBovine, porcine, equidae
2.81.LuprostiolAll mammalian species"
C.Annex III is amended as follows:1.Anti-infectious agents1.2.Antibiotics1.2.5.Aminoglycosides
Pharmacologically active substanceMarker residueAnimal speciesMRLsTarget tissuesOther provisions
"1.2.5.7.ApramycinApramycinBovine1000 μg/kgMuscle, fatFor use in non-lactating cattle only Provisional MRLs expire on 1. 7. 1999
10000 μg/kgLiver
20000 μg/kgKidney
Porcine1000 μg/kgMuscle, skin + fat, liverProvisional MRLs expire on 1. 7. 1999"
5000 μg/kgKidney