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)
L_1997263EN. 01001401. xml 25. 9. 1997    EN Official Journal of the European Communities L 263/14 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) 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 origin (1), as last amended by Commission Regulation (EC) No 749/97 (2), 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/EEC (3), as last amended by Directive 93/40/EEC (4), 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 1 Annexes I, II and III to Regulation (EEC) No 2377/90 are hereby amended as set out in the Annex hereto. Article 2 This 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 Commission Martin BANGEMANN Member of the Commission (1)  OJ L 224, 18. 8. 1990, p. 1. (2)  OJ L 110, 26. 4. 1997, p. 24. (3)  OJ L 317, 6. 11. 1981, p. 1. (4)  OJ L 214, 24. 8. 1993, p. 31. ANNEX The Annexes to Regulation (EEC) No 2377/90 are hereby amended as follows: A. Annex I is amended as follows: 1. Anti-infectious agents 1. 1. Chemotherapeutics 1. 1. 2. Diamino pyrimidine derivates Pharmacologically active substance Marker residue Animal species MRLs Target tissues Other provisions ‘1. 1. 2. 1. Baquiloprim Baquiloprim Bovine 10 μg/kg Fat   300 μg/kg Liver 150 μg/kg Kidney 30 μg/kg Milk Porcine 40 μg/kg Skin + fat 50 μg/kg Liver, kidney’ 1. 2. Antibiotics 1. 2. 4. Macrolides Pharmacologically active substance Marker residue Animal species MRLs Target tissues Other provisions ‘1. 2. 4. 3. Tylosin Tylosin A Bovine 100 μg/kg Muscle, fat, liver, kidney   50 μg/kg Milk Porcine 100 μg/kg Muscle, skin + fat, liver, kidney Poultry 100 μg/kg Muscle, skin + fat, liver, kidney Not for use in hens producing eggs for human consumption’ 4. Anti-inflammatory agents 4. 1. Nonsteroidal anti-inflammatory agents 4. 1. 2. Fenamate group derivatives Pharmacologically active substance Marker residue Animal species MRLs Target tissues Other provisions ‘4. 1. 2. 1. Tolfenamic acid Tolfenamic acid Bovine 50 μg/kg Muscle   400 μg/kg Liver 100 μg/kg Kidney 50 μg/kg Milk Porcine 50 μg/kg Muscle 400 μg/kg Liver 100 μg/kg Kidney’ B. Annex II is amended as follows: 1. Inorganic compounds Pharmacologically active substance(s) Animal species Other provisions ‘1. 30. Bismuth subcarbonate All food-producing species For oral use only 1. 31. Bismuth subgallate All food-producing species For oral use only 1. 32. Bismuth subnitrate All food-producing species For oral use only 1. 33. Bismuth subsalicylate All food-producing species For oral use only’ 2. Organic compounds Pharmacologically active substance(s) Animal species Other provisions ‘2. 79. Cloprostenol Bovine, porcine, equidae   2. 80. R-Cloprostenol Bovine, porcine, equidae   2. 81. Luprostiol All mammalian species’   C. Annex III is amended as follows: 1. Anti-infectious agents 1. 2. Antibiotics 1. 2. 5. Aminoglycosides Pharmacologically active substance Marker residue Animal species MRLs Target tissues Other provisions ‘1. 2. 5. 7. Apramycin Apramycin Bovine 1 000 μg/kg Muscle, fat For use in non-lactating cattle only Provisional MRLs expire on 1. 7. 1999 10 000 μg/kg Liver 20 000 μg/kg Kidney Porcine 1 000 μg/kg Muscle, skin + fat, liver Provisional MRLs expire on 1. 7. 1999’ 5 000 μg/kg Kidney