Commission Regulation (EC) No 953/1999 of 5 May 1999 amending Annexes II 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 (Text with EEA relevance)
6. 5. 1999 EN Official Journal of the European Communities L 118/23 COMMISSION REGULATION (EC) No 953/1999 of 5 May 1999 amending Annexes II 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 (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 veter- inary medicinal products in foodstuffs of animal origin (1), as last amended by Commission Regulation (EC) No 804/ 1999 (2) and in particular Articles 6, 7 and 8 thereof, (1) Whereas, in accordance with Regulation (EEC) No 2377/90, maximum residue limits must be estab- lished progressively for all pharmacologically active substances which are used within the Community in veterinary medicinal products intended for administration to food-producing animals; (2) Whereas maximum residue limits should be estab- lished only after the examination within the Committee for Veterinary Medicinal Products of all the relevant information concerning the safety of residues of the consumer of foodstuffs of animal origin and the impact of residues on the industrial processing of foodstuffs; the substance concerned for (3) 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); maximum residue limits always be established for muscle or fat tissues; should therefore also (5) Whereas, in the case of veterinary medicinal pro- ducts intended for use in laying birds, lactating animals or honey bees, maximum residue limits must also be established for eggs, milk or honey; (6) Whereas parconazole should be inserted into Annex II to Regulation (EEC) No 2377/90; (7) Whereas, in order to allow for the completion of scientific studies, imidocarb, carazolol, pirlimycin, danofloxacin, josamycin and bacitracin should be inserted into Annex III to Regulation (EEC) No 2377/90; (8) 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 adjust- ment which may be necessary to the authorisations veterinary medicinal products to place concerned on the market which have been granted in 81/ accordance with Council Directive 851/EEC (3), as last amended by Directive 93/ 40/EEC (4) to take account of the provisions of this Regulation; the (9) Whereas the measures provided for in this Regula- tion are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products, HAS ADOPTED THE FOLLOWING REGULATION Article 1 Annexes II and III of Regulation (EEC) No 2377/90 are hereby amended as set out in the Annex hereto. (4) 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 and carcasses moving in international trade, Article 2 This Regulation shall enter into force on the 60th day following its publication in the Official Journal of the European Communities. (1) OJ L 224, 18. 8. 1990, p. 1. (2) OJ L 102, 17. 4. 1999, p. 58. (3) OJ L 317, 6. 11. 1981, p. 1. (4) OJ L 214, 24. 8. 1993, p. 31. L 118/24 EN Official Journal of the European Communities 6. 5. 1999 This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 5 May 1999. For the Commission Martin BANGEMANN Member of the Commission A. Annex II to Regulation (EEC) No 2377/90 is amended as follows: 2. Organic compounds ANNEX Pharmacologically active substance(s) Animal species Other provisions ‘Parconazole Guinea fowl' B. Annex III to Regulation (EEC) No 2377/90 is amended as follows: 1. Anti-infectious agents 1. 2. Antibiotics 1. 2. 2. Macrolides Pharmacologically active substance(s) ‘Josamycin 1. 2. 6. Quinolones Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Sum of the microbiolog- ically active metabolites, expressed as josamycin Porcine 200 lg/kg Muscle 200 lg/kg 200 lg/kg 400 lg/kg Kidney Skin and fat Liver Provisional MRLs expire on 1. 7. 2002' Marker residue Animal species MRLs Target tissues Other provisions ‘Danofloxacin Danofloxacin Porcine 100 lg/kg Muscle 50 lg/kg 200 lg/kg 200 lg/kg Kidney Skin and fat Liver Provisional MRLs expire on 1. 1. 2000' 6. 5. 1 9 9 9 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 2 5 1. 2. 12. Polypeptides Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ‘Bacitracin Bacitracin Bovine 150 lg/kg Milk Provisional MRLs expire on 1. 7. 2001' 1. 2. 13. Lincosamides Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ‘Pirlimycin Pirlimycin Bovine Provisional MRLs expire on 1. 7. 2000' 100 lg/kg Muscle 100 lg/kg 1 000 lg/kg Fat Liver 400 lg/kg Kidney 100 lg/kg Milk 2. Antiparasitic agents 2. 4. Agents acting against protozoa 2. 4. 1. Carbanilides Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ‘Imidocarb Imidocarb Bovine, ovine Provisonal MRLs expire on 1. 1. 2002' 300 lg/kg Muscle 50 lg/kg 2 000 lg/kg 1 500 lg/kg Kidney 50 lg/kg Milk Fat Liver L 1 1 8 / 2 6 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s 6. 5. 1 9 9 9 3. 3. 2. Agents acting on the nervous system Agents acting on the autonomic nervous system 3. 2. 2. Anti-adrenergics Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ‘Carazolol Carazolol Bovine Provisional MRLs expire on 1. 1. 2000' 5 lg/kg Muscle 5 lg/kg 15 lg/kg 15 lg/kg Kidney 1 lg/kg Milk Fat Liver 6. 5. 1 9 9 9 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n C o m m u n i t i e s L 1 1 8 / 2 7