Commission Regulation (EC) No 804/1999 of 16 April 1999 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 originText with EEA relevance
L 102/58 EN Official Journal of the European Communities 17. 4. 1999 COMMISSION REGULATION (EC) No 804/1999 of 16 April 1999 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, honey bees, maximum residue limits must also be estab- lished for eggs, milk or honey; Having regard to the Treaty establishing the European Community, Whereas lincomycin and ceftiofur should be inserted into Annex I to Regulation (EEC) No 2377/90; 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 508/ 1999 (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 progres- sively 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 informa- tion 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 resi- dues 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 resi- dues (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 inter- national trade, and maximum residue limits should there- fore also always be established for muscle or fat tissues; Whereas melissae aetheroleum, centellae asiaticae extractum, strychnine, 1-methyl-2-pyrrolidone, etamsy- late, enilconazole and cefacetrile should be inserted into Annex II to Regulation (EEC) No 2377/90; Whereas, in order to allow for the completion of scientific studies, oxolinic acid, cefacetrile and thiamphenicol should be inserted into Annex III to Regulation (EEC) No 2377/90; Whereas, in order to allow for the completion of scientific studies, the duration of the validity of the provisional maximum residue limits previously defined in Annex III to Regulation (EEC) No 2377/90 should be extended for nafcillin and cephapirin; 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 authorisations 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 Whereas, in the case of veterinary medicinal products lactating animals or intended for use in laying birds, 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 60, 9. 3. 1999, p. 16. (3) OJ L 317, 6. 11. 1981, p. 1. (4) OJ L 214, 24. 8. 1993, p. 31. 17. 4. 1999 EN Official Journal of the European Communities L 102/59 This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 16 April 1999. For the Commission Martin BANGEMANN Member of the Commission A. Annex I to Regulation (EEC) No 2377/90 is amended as follows: ANNEX 1. Anti-infectious agents 1. 2. Antibiotics 1. 2. 2. Cephalosporins Pharmacologically active substance(s) ‘Ceftiofur 1. 2. 9. Lincosamides Marker residue Animal species MRLs Target tissues Other provisions Sum of residues all retaining the betalactam expressed as structure desfuroylceftiofur Bovine Porcine 1 000 lg/kg Muscle 2 000 lg/kg Fat 2 000 lg/kg Liver 6 000 lg/kg Kidney 100 lg/kg Milk, not for intramammary use 1 000 lg/kg Muscle 2 000 lg/kg Fat 2 000 lg/kg Liver 6 000 lg/kg Kidney' Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ‘Lincomycin Lincomycin Bovine 100 lg/kg Muscle 50 lg/kg Fat 500 lg/kg Liver 1 500 lg/kg Kidney 150 lg/kg Milk' L 1 0 2 / 6 0 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 7. 4. 1 9 9 9 B. Annex II to Regulation (EEC) No 2377/90 is amended as follows: 2. Organic compounds Pharmacologically active substance(s) Animal species Other provisions ‘1-Methyl-2-pyrrolidone Cefacetrile Enilconazole Etamsylate Strychnine 6. Substances of vegetable origin Equidae Bovine For intramammary use only and for all tissues except milk Bovine, equidae For topical use only All food producing species Bovine For oral use only at dose to 0,1 mg/kg bw' Pharmacologically active substance(s) Animal species Other provisions ‘Centellae asiaticae extractum All food producing species For topical use only' Melissae aetheroleum All food producing species C. Annex III to Regulation (EEC) No 2377/90 is amended as follows: Anti-infectious agents Antibiotics 1. 1. 2. 1. 2. 4. Cephalosporins Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ‘Cefacetrile Cefacetrile Bovine 125 lg/kg Milk Cephapirin Sum of cephapirin and desacetylcephapirin Bovine 50 lg/kg Muscle 50 lg/kg 50 lg/kg 100 lg/kg Kidney 10 lg/kg Milk Fat Liver Provisional MRLs expire on 1. 1. 2001 For intramammary use only Provisional MRLs expire on 1. 1. 2001' 1 7. 4. 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 0 2 / 6 1 1. 2. 6. Quinolones Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ‘Oxolinic acid Oxolinic acid Bovine 100 lg/kg Muscle Provisional MRLs expire on 1. 1. 2001' Porcine Chicken 50 lg/kg Fat 150 lg/kg Liver 150 lg/kg Kidney 100 lg/kg Muscle 50 lg/kg Skin + fat 150 lg/kg Liver 150 lg/kg Kidney 100 lg/kg Muscle 50 lg/kg Skin + fat 150 lg/kg Liver 150 lg/kg Kidney 50 lg/kg Eggs Fin fish 300 lg/kg Muscle and skin in natural proportions 1. 2. 10. Penicillins Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ‘Nafcillin Nafcillin Bovine 300 lg/kg Muscle Provisional MRLs expire on 1. 1. 2001' 300 lg/kg Fat 300 lg/kg Liver 300 lg/kg Kidney 30 lg/kg Milk L 1 0 2 / 6 2 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 7. 4. 1 9 9 9 1. 2. 11. Florfenicol and related compounds Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ‘Thiamphenicol Thiamphenicol Ovine Porcine Fin fish Provisional MRLs expire on 1. 1. 2001' 50 lg/kg Muscle 50 lg/kg 50 lg/kg 50 lg/kg Kidney Fat Liver 50 lg/kg Muscle 50 lg/kg 50 lg/kg 50 lg/kg Kidney Skin + fat Liver 50 lg/kg Muscle and skin in natural proportions 1. 2. 13. Lincosamides Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ‘Lincomycin Lincomycin Ovine Porcine Chicken Provisional MRLs expire on 1. 1. 2001' 100 lg/kg Muscle 50 lg/kg 500 lg/kg Fat Liver 1 500 lg/kg Kidney 150 lg/kg Milk 100 lg/kg Muscle 50 lg/kg 500 lg/kg Skin + fat Liver 1 500 lg/kg Kidney 100 lg/kg Muscle 50 lg/kg 500 lg/kg Skin + fat Liver 1 500 lg/kg Kidney 50 lg/kg Eggs 1 7. 4. 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 0 2 / 6 3