Commission Regulation (EC) No 2728/98 of 17 December 1998 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)
L 343/8 EN Official Journal of the European Communities 18. 12. 98 COMMISSION REGULATION (EC) No 2728/98 of 17 December 1998 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, 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 2692/98 (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 re- sidues 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 inter- national trade, and maximum residue limits should there- fore also always be established for muscle or fat tissues; Whereas enrofloxacin and ivermectin should be inserted into Annex I to Regulation (EEC) No 2377/90; Whereas hyperici oleum, eucalypti aetheroleum, sodium 2-methyl-2-phenoxy-propanoate, nonivamide, nicoboxil, methyl nicotinate, mecillinam, 8-hydroxyquinoline and diethylene glycol monoethyl ether should be inserted into Annex II 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 enrofloxacin; 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 338, 15. 12. 1998, p. 5. (3) OJ L 317, 6. 11. 1981, p. 1. (4) OJ L 214, 24. 8. 1993, p. 31. 18. 12. 98 EN Official Journal of the European Communities L 343/9 This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 17 December 1998. For the Commission Martin BANGEMANN Member of the Commission A. Annex I to Regulation (EEC) No 2377/90 is amended as follows: ANNEX 1. 1. 2. Anti-infectious agents Antibiotics 1. 2. 3. Quinolones Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Enrofloxacin Sum of enrofloxacin and ciprofloxacin Bovine Rabbits Porcine Poultry Not for use in animals from which eggs are produced for human con- sumption 100 lg/kg Muscle 100 lg/kg 300 lg/kg 200 lg/kg Kidney 100 lg/kg Milk Fat Liver 100 lg/kg Muscle 100 lg/kg 200 lg/kg 300 lg/kg Kidney Fat Liver 100 lg/kg Muscle 100 lg/kg 200 lg/kg 300 lg/kg Kidney Skin + fat Liver 100 lg/kg Muscle 100 lg/kg 200 lg/kg 300 lg/kg Kidney Skin + fat Liver 2. 2. 3. Antiparasitic agents Agents acting against endo- and ectoparasites 2. 3. 1. Avermectins Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Ivermectin 22,23-Dihydro-aver- mectin B1a Deer, including reindeer 20 lg/kg Muscle 100 lg/kg 50 lg/kg 20 lg/kg Kidney Fat Liver L 3 4 3 / 1 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 8. 1 2. 9 8 B. Annex II to Regulation (EEC) No 2377/90 is amended as follows: 2. Organic compounds Pharmacologically active substance(s) Animal species Other provisions 8-Hydroxyquinoline All mammalian food producing species For topical use in new-born animals only Diethylene glycol monoethyl ether Mecillinam Methyl nicotinate Nicoboxil Nonivamide Bovine, porcine Bovine Bovine, equidae Equidae Equidae Sodium 2-methyl-2-phenoxy-propanoate Bovine, porcine, caprine, equidae 6. Substances of vegetable origin For intra-uterine use only For topical use only For topical use only For topical use only Pharmacologically active substance(s) Animal species Other provisions Eucalypti aetheroleum Hyperici oleum All food producing species All food producing species For topical use only C. Annex III to Regulation (EEC) No 2377/90 is amended as follows: 1. 1. 2. Anti-infectious agents Antibiotics 1. 2. 06. Quinolones Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Enrofloxacin Sum of enrofloxacin and Ovine ciprofloxacin 100 lg/kg Muscle 100 lg/kg 300 lg/kg 200 lg/kg Kidney Fat Liver Provisional MRLs expire on 1 July 1999 1 8. 1 2. 9 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 L 3 4 3 / 1 1