Commission Regulation (EEC) No 3092/92 of 27 October 1992 amending Annex 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
Date: 1992-10-27
Institutions: European Commission
Subjects: animal product, health control, pharmaceutical legislation, veterinary medicinal product, veterinary medicine













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31992R3093

Commission Regulation (EEC) No 3092/92 of 27 October 1992 amending Annex 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  


Official Journal L 311 , 28/10/1992 P. 0018 - 0019 Finnish special edition: Chapter 3 Volume 45 P. 0137  Swedish special edition: Chapter 3 Volume 45 P. 0137  





COMMISSION REGULATION (EEC) No 3093/92  of 27 October 1992  amending Annex 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 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), as last amended by Commission  Regulation (EEC) No 762/92 (2), 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 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 albendazole, amitraz, thiabendazole and tylosin 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/EEC (3), as amended by Directive 90/676/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 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  Annex III of Regulation (EEC) No 2377/90 is 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, 27 October 1992. For the Commission  Martin BANGEMANN  Vice-President   (1) OJ No L 224, 18. 8. 1990, p. 1. (2) OJ No L 83, 28. 3. 1992, p. 14. (3) OJ No L 317, 6. 11. 1981, p. 1. (4) OJ No L 373, 31. 12. 1990, p. 15.    ANNEX  Annex III is modified as follows:  I. Under 1.2.3. Macrolides the following heading is inserted:          Pharmacologically active substances  Marker residue  Animal species  MRLs  Target tissues  Other provisions         '1.2.3.2. Tylosin  Tylosin  bovine  porcine  poultry  100 mg/kg  muscle  liver  kidney  Provisional MRLs expire on 1. 7. 1995.'    bovine  50 mg/kg  milk         II. Under 2.1.1. Benzimidazoles and pro-benzimidazoles the following are inserted:          Pharmacologically active substances  Marker residue  Animal species  MRLs  Target tissues  Other provisions         '2.1.1.4. Albendazole  Sum of albendazole and metabolites which are measured as 2-amino-benzimidazole sulphone  bovine  ovine  100 mg/kg  500 mg/kg  1 000 mg/kg  muscle  fat  milk  kidney  liver  Provisional MRLs expire on 1. 1. 1996.  2.1.1.5. Thiabendazole  Sum of thiabendazole and 5-hydroxythiabendazole  bovine  ovine  caprine  100 mg/kg  muscle  liver  kidney  fat  milk  Provisional MRLs expire on 1. 1. 1996.'        III. The following heading is added:  '2.2. Agents acting against ectoparasites          Pharmacologically active substances  Marker residue  Animal species  MRLs  Target tissues  Other provisions         2.2.1. Amitraz  Sum of amitraz and metabolites which are measured as 2.4-dimethylaniline  porcine  50 mg/kg 200 mg/kg   muscle kidney, liver  Provisional MRLs expire on 1. 7. 1994.'