Commission Regulation (EC) No 2686/98 of 11 December 1998 amending Annexes I and II 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 337/20 EN Official Journal of the European Communities 12. 12. 98 COMMISSION REGULATION (EC) No 2686/98 of 11 December 1998 amending Annexes I and II 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 2560/98 (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 res- idues 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 res- idues (marker residue); 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 estab- lished for eggs, milk or honey; Whereas flumethrin should be inserted into Annex I to Regulation (EEC) No 2377/90; Whereas oleyloleate, calcium glucoheptonate, calcium glucono glucoheptonate, calcium gluconolactate, calcium glutamate, nickel gluconate, nickel sodium hypophosphite, bacitracin, bronopol, cetostearyl alcohol, sodium menadione, phytomenadione, cetostearyl sulphate, wool alcohols, lespedeza capitata, majoranae herba, medicago sativa extractum, sinapis nigrae semen and flumethrin should be inserted into Annex II to Regulation (EEC) No 2377/90; 2-pyrrolidone, sulphate, 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 THE FOLLOWING REGULATION: Article 1 Annexes I and II of Regulation (EEC) No 2377/90 are hereby amended as set out in the Annex hereto. 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 carcasses moving in inter- national trade, and maximum residue limits should there- fore also always be established for muscle or fat tissues; 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 320, 28. 11. 1998, p. 28. (3) OJ L 317, 6. 11. 1981, p. 1. (4) OJ L 214, 24. 8. 1993, p. 31. 12. 12. 98 EN Official Journal of the European Communities L 337/21 This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 11 December 1998. For the Commission Martin BANGEMANN Member of the Commission A. Annex I to Regulation (EC) No 2377/90 is amended as follows: ANNEX 2. Antiparasitic agents 2. 2. Agents acting against ectoparasites 2. 2. 3. Pyrethroids Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions ‘Flumethrin Flumethrin trans-Z isomers) (sum of Bovine 10 lg/kg Muscle 150 lg/kg 20 lg/kg 10 lg/kg Kidney 30 lg/kg Milk' Fat Liver B. Annex II to Regulation (EC) No 2377/90 is amended as follows: 1. Inorganic chemicals Pharmacologically active substance(s) Animal species Other provisions ‘Calcium glucoheptonate All food-producing species Calcium glucono glucoheptonate All food-producing species Calcium gluconolactate Calcium glutamate Nickel gluconate Nickel sulphate Sodium hypophosphite All food-producing species All food-producing species All food-producing species All food-producing species All food-producing species' L 3 3 7 / 2 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 2. 1 2. 9 8 2. Organic compounds Pharmacologically active substance(s) Animal species Other provisions ‘2-Pyrrolidone Bacitracin Bronopol Cetostearyl alcohol Flumethrin Menadione Oleyloleate Phytomenadione Sodium cetostearyl sulphate Wool alcohols 6. Substances of vegetable origin All food-producing species At parenteral doses up to 40 mg/kg bw Bovine Salmonidae All food-producing species Honey bees All food-producing species All food-producing species All food-producing species All food-producing species All food-producing species For intramammary use in lactating cows only and for all tissues except milk For use only on farmed fertilised eggs For topical use only For topical use only For topical use only' Pharmacologically active substance(s) Animal species Other provisions ‘Lespedeza capitata Majoranae herba Medicago sativa extractum Sinapis nigrae semen All food-producing species All food-producing species All food-producing species All food-producing species' For topical use only 1 2. 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 3 7 / 2 3