Commission Regulation (EC) No 997/1999 of 11 May 1999 amending Annexes I, 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)
L 122/24 EN Official Journal of the European Communities 12. 5. 1999 COMMISSION REGULATION (EC) No 997/1999 of 11 May 1999 amending Annexes I, 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 954/ 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 the liver and kidney are frequently removed from carcasses moving in international and maximum residue limits should therefore also always be established for muscle or fat tissues; trade, (5) Whereas, in the case of veterinary medicinal prod- lactating ucts intended for use in laying birds, animals or honey bees, maximum residue limits must also be established for eggs, milk or honey; (6) Whereas Nitroxinil should be inserted into Annex I to Regulation (EEC) No 2377/90; (7) Whereas pyrantel embonate, bromhexine, mercap- tamine hydrochloride, biotin, Praziquantel, vitamin E, sodium glycerophosphate, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6 and vitamin B12 should be inserted into Annex II to Regulation (EEC) No 2377/90; (8) Whereas, in order to allow for the completion of scientific studies, morantel, halofuginone, difluben- zuron, difloxacin and Oxyclozanide should be inserted into Annex III to Regulation (EEC) No 2377/90; (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); (9) 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 to place veterinary medicinal products concerned on the market which have been granted 81/ accordance with Council Directive in 851/EEC (3), as last amended by Directive 93/ 40/EEC (4) to take account of the provisions of this Regulation; the (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, (10) Whereas the measures provided for in this Regula- tion are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products, (1) OJ L 224, 18. 8. 1990, p. 1. (2) OJ L 118, 6. 5. 1999, p. 28. (3) OJ L 317, 6. 11. 1981, p. 1. (4) OJ L 214, 24. 8. 1993, p. 31. 12. 5. 1999 EN Official Journal of the European Communities L 122/25 HAS ADOPTED THIS REGULATION: Article 2 Article 1 Annexes I, II and III of Regulation (EEC) No 2377/90 are hereby amended as set out in the Annex hereto. This Regulations 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, 11 May 1999. For the Commission Martin BANGEMANN Member of the Commission Annex I to Regulation (EEC) No 2377/90 is amended as follows: 2. Antiparasitic agents 2. 1. Agents acting against endoparasites 2. 1. 4. Phenol derivatives including salicylanides ANNEX Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ‘Nitroxinil Nitroxinil Bovine, ovine 400 lg/kg Muscle 200 lg/kg 20 lg/kg 400 lg/kg Kidney' Fat Liver Annex II to Regulation (EEC) No 2377/90 is amended as follows: 1. Inorganic chemicals Pharmacologically active substance(s) Animal species Other provisions ‘Sodium glycerophosphate All food producing species' 2. Organic compounds Pharmacologically active substance(s) Animal species Other provisions ‘Biotin Bromhexine All food producing species Bovine Not for use in animals from which milk is produced for human consumption Porcine Poultry Not for use in animals from which eggs are produced for human consumption L 1 2 2 / 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 1 2. 5. 1 9 9 9 Pharmacologically active substance(s) Animal species Other provisions Mercaptamine hydrochloride All mammalian food-producing species Praziquantel Pyrantel embonate Vitamin B1 Vitamin B12 Vitamin B2 Vitamin B3 Vitamin B5 Vitamin B6 Vitamin E Ovine Equidae All food-producing species All food-producing species All food-producing species All food-producing species All food-producing species All food-producing species All food-producing species' Annex III to Regulation (EEC) No 2377/90 is amended as follows: 1. Anti-infectious agents 1. 2. Antibiotics 1. 2. 6. Quinolones Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ‘Difloxacin Difloxacin Bovine Not for use in animals from which milk is produced for human consumption Porcine 400 lg/kg Muscle 100 lg/kg 1 400 lg/kg Fat Liver 800 lg/kg Kidney 400 lg/kg Muscle 100 lg/kg 800 lg/kg 800 lg/kg Kidney Skin and fat Liver Provisional MRLs expire on 1. 1. 2001' 1 2. 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 2 2 / 2 7 2. Antiparasitic agents 2. 1. Agents acting against endoparasites 2. 1. 1. Phenol derivatives including salicylanides Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ‘Oxyclozanide Oxyclozanide Bovine Ovine 20 lg/kg Muscle 20 lg/kg 500 lg/kg 100 lg/kg Kidney 10 lg/kg Milk Fat Liver 20 lg/kg Muscle 20 lg/kg 500 lg/kg 100 lg/kg Kidney Fat Liver Provisional MRLs expire on 1. 7. 2000' 2. 1. 3. Tetrahydropyrimides Pharmacologically active substance(s) ‘Morantel Marker residue Animal species MRLs Target tissues Other provisions Bovine, ovine Sum of residues which may be hydrolysed to N- Methyl-1,3-propanedia- mine and expressed as morantel equivalents Porcine 100 lg/kg 100 lg/kg 800 lg/kg 200 lg/kg 100 lg/kg 100 lg/kg 100 lg/kg 800 lg/kg 200 lg/kg Muscle Fat Liver Kidney Milk Muscle Skin and fat Liver Kidney Provisional MRLs expire on 1. 7. 2001' 2. 2. Agents acting against ectoparasites 2. 2. 5. Acyl urea derivates Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ‘Diflubenzuron Diflubenzuron Salmonidae 1 000 lg/kg Muscle and skin in natural proportions Provisional MRLs expire on 1. 7. 2000' L 1 2 2 / 2 8 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 1 2. 5. 1 9 9 9 2. 4. Agents acting against protozoa 2. 4. 2. Quinazolone derivatives Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ‘Halofuginone Halofuginone Bovine Provisional MRL’s expire on 1. 1. 2001' 10 lg/kg Muscle 25 lg/kg 30 lg/kg 30 lg/kg Kidney Fat Liver 1 2. 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 2 2 / 2 9