Commission Regulation (EEC) No 675/92 of 18 March 1992 amending Annexes I 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
Date: 1992-03-18
Institutions: European Commission
Subjects: animal product, health control, pharmaceutical legislation, veterinary medicinal product, veterinary medicine













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31992R0675

Commission Regulation (EEC) No 675/92 of 18 March 1992 amending Annexes I 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  


Official Journal L 073 , 19/03/1992 P. 0008 - 0014 Finnish special edition: Chapter 3 Volume 41 P. 0108  Swedish special edition: Chapter 3 Volume 41 P. 0108  





COMMISSION REGULATION (EEC) No 675/92  of 18 March 1992  amending Annexes I 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 originTHE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic 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), and in particular Articles 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 tissue 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 the sulfonamide group of substances (in respect of residues in meat), ivermectin, benzylpenicillin, ampicillin, amoxicillin, oxacillin, cloxacillin and dicloxacillin should be inserted into Annex I to Regulation (EEC) No 2377/90;  Whereas dimetridazole, ronidazole, chloramphenicol, azaperone and carazolol, the nitrofurans group, trimethoprim, dapsone, compounds belonging to the tetracyclines group, spiramycin, febantel, fenbendazole, oxfendazole, levamisol and sulfonamide group  (in respect of residues in milk) should be inserted into Annex III to Regulation (EEC) No 2377/90; whereas it is necessary to define the duration of the provisional maximum residue limits;  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/CEE (2) 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 Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Veterinary Medicinal Products  Sector,  HAS ADOPTED THIS REGULATION:  Article 1  Annexes I and III of 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 60 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, 18 March 1992. For the Commission  Martin BANGEMANN  Vice-President   (1) OJ No L 224, 18. 8. 1990, p. 1. (2) OJ No L 317, 6. 11. 1981, p. 1.    ANNEX  A. Annex I is hereby replaced by the following:  'ANNEX I  List of pharmacologically active substances for which maximum residue limits have been fixed  1. Anti-infectious agents  1.1. Chemotherapeutics  1.1.1. Sulfonamides          Pharmacologically active substance(s)  Marker residue  Animal species  MRLs  Target tissues  Other provisions         All substances belonging to the sulfonamide group  Parent drug  All food producing species  100 mg/kg  Muscle, liver,  kidney, fat  The combined total residues of all substances within the sulfonamide group should not excced 100 mg/kg        1.2. Antibiotics  1.2.1. Penicillins          Pharmacologically active substance(s)  Marker residue  Animal species  MRLs  Target tissues  Other provisions         1.2.1.1. Benzylpenicillin  Parent drug  All food producing species  50 mg/kg  Muscle, liver, kidney, fat      4 mg/kg   milk   1.2.1.2. Ampicillin  Parent drug  All food producing species  50 mg/kg  Muscle, liver, kidney, fat      4 mg/kg  milk   1.2.1.3. Amoxicillin  Parent drug  All food producing species  50 mg/kg  Muscle, liver, kidney, fat      4 mg/kg  milk    1.2.1.4. Oxacillin  Parent drug  All food producing species  300 mg/kg  Muscle, liver, kidney, fat      30 mg/kg  milk   1.2.1.5. Cloxacillin  Parent drug  All food producing species  300 mg/kg  Muscle, liver, kidney, fat      30 mg/kg  milk    1.2.1.6. Dicloxacillin  Parent drug  All food producing species  300 mg/kg  Muscle, liver, kidney, fat      30 mg/kg  milk         2. Antiparasitic agents  2.1. Agents acting against endoparasites  2.1.1. Avermectins          Pharmacologically active substance(s)  Marker residue  Animal species  MRLs  Target tissues  Other provisions         2.1.1.1. Ivermectin  H2B1a   metabolite  Bovine, ovine, porcine, equine  15 mg/kg  20 mg/kg  Liver fat  The MRLs for liver and fat apply to all four species mentioned'        B. Annex III is hereby replaced by the following:  'ANNEX III  List of pharmacologically active substances used in veterinary medicinal products for which provisional maximum residue limits have been fixed  1. Anti-infectious agents  1.1. Chemotherapeutics  1.1.1. Sulfonamides          Pharmacologically active substance(s)  Marker residue  Animal species  MRLs  Target tissues  Other provisions         All substances belonging to the sulfonamide group  Parent drug  Cattle, sheep, goats  100 mg/kg  milk  Provisional MRL  expires on 1 January 1994.  The combined total residues of all substances within the sulfonamide group should not exceed 100 mg/kg.        1.1.2. Diamino pyrimidine derivates          Pharmacologically active substance(s)  Marker residue  Animal species  MRLs  Target tissues  Other provisions         1.1.2.1. Trimethoprim  Parent drug  All food producing species  50 mg/kg  Muscle, liver, kidney, fat milk  Provisional MRL  expires on 1 January 1996        1.1.3. Nitrofurans          Pharmacologically active substance(s)  Marker residue  Animal species  MRLs  Target tissues  Other provisions         All substances belonging to the nitrofuran group  All residues with intact 5-nitro structure  All food producing species   5 mg/kg  Muscle, liver, kidney, fat  Provisional MRL expires on 1 July 1993  The combined total residues of all substances within this group should not exceed 5 mg/kg        1.1.4. Nitroimidazoles          Pharmacologically active substance(s)  Marker residue  Animal species  MRLs  Target tissues  Other provisions         1.1.4.1. Dimetridazole  All residues with intact nitroimidazole structure  All food producing species  10 mg/kg  Muscle,  liver, kidney, fat  Provisional MRL expires on 1 January 1994  1.1.4.2. Ronidazole  All residues with intact nitroimidazole structure  All food producing species  2 mg/kg  Muscle, liver, kidney, fat  Provisional MRL expires on 1 January 1994         1.1.n. Other chemotherapeutics          Pharmacologically active substance(s)  Marker residue  Animal species  MRLs  Target tissues  Other provisions         1.1.n.1. Dapsone  Parent drug  All food producing species  25 mg/kg  Muscle, liver, kidney, fat  Provisional MRL expires  on 1 January 1994     25 mg/kg  milk         1.2. Antibiotics  1.2.2. Tetracyclines          Pharmacologically active substance(s)  Marker residue  Animal species  MRLs  Target tissues  Other provisions         All substances belonging to the tetracycline group  Parent drug  All food producing species  600 mg/kg  300 mg/kg  200 mg/kg  100 mg/kg  100 mg/kg  Kidney,  liver  eggs,  muscle,  milk  Provisional MRLs expires on 1 January 1994. The combined total residues of all substances within the tetracycline group should not exceed the limits indicated        1.2.3. Macrolides          Pharmacologically active substance(s)  Marker residue  Animal species  MRLs  Target tissues  Other provisions         1.2.3.1. Spiramycin  Parent drug  Bovine, porcine  300 mg/kg  200 mg/kg  50 mg/kg  Liver  kidney  muscle  Provisional MRLs expire on 1 July 1995    bovine  150 mg/kg  milk  The MRLs for liver, kidney and muscle apply to both the bovine and porcine species        1.2.4. Chloramphenicol and related compounds          Pharmacologically active substance(s)  Marker residue  Animal species  MRLs  Target tissues  Other provisions         1.2.4.1. Chloramphenicol  Parent drug  All food producing species  10 mg/kg  Muscle, liver, kidney, fat  Provisional MRL  expires on July 1994        2. Antiparasitic agents  2.1. Agents acting against endo-parasites  2.1.1. Benzimidazoles and pro-benzimidazoles          Pharmacologically active substance(s)  Marker residue  Animal species  MRLs  Target tissues  Other provisions         2.1.1.1. Febantel  2.1.1.2. Fenbendazole  2.1.1.3. Oxfendazole  combined residues of oxfendazole, oxfendazole sulfone and fenbendazole  All food producing species  1 000 mg/kg  10 mg/kg  10 mg/kg  Liver  muscle, kidney, fat  milk  Provisional MRLs expire on 1 July 1995  The MRLs cover all residues of febantel, fenbendazole and oxfendazole        2.1.2. Tetra-hydro-imidazoles (imidazolthiazoles)          Pharmacologically active substance(s)  Marker residue  Animal species  MRLs  Target tissues  Other provisions         2.1.2.1. Levamisol  Parent drug  All food producing species  10 mg/kg  Muscle, liver, kidney, fat, milk  Provisional MRL  expires on 1 January 1995        3. Agents acting on the nervous system  3.1. Agents acting on the central nervous system  3.1.1. Butyrofenone tranquillizers          Pharmacologically active substance(s)  Marker residue  Animal species  MRLs  Target tissues  Other provisions         3.1.1.1. Azaperone  Azaperol  All food producing species  100 mg/kg  50 mg/kg  kidney  liver, muscle, fat  Provisional MRLs expire on 1 January 1996        3.2. Agents acting on the autonomic nervous system  3.2.1. Anti-adrenergics          Pharmacologically active substance(s)  Marker residue  Animal species  MRLs  Target tissues  Other provisions         3.2.1.1. Carazolol  Parent drug  All food producing species  30 mg/kg  5 mg/kg  Liver, kidney  muscle, fat  Provisional MRLs expire on 1 July 1995'