COMMISSION REGULATION (EEC) No 3093/92 of 27 October 1992 amending Annex 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

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic 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 veterinary medicinal products in foodstuffs of animal origin (1), as last amended by Commission Regulation (EEC) No 762/92 (2), and in particular Articles 7 and 8 thereof,

Whereas, in accordance with Regulation (EEC) No 2377/90, maximum residue limits must be established progressively 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 information 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 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);

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 international trade, and maximum residue limits should therefore also always be established for muscle or fat tissues;

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 established for eggs, milk or honey;

Whereas albendazole, amitraz, thiabendazole and tylosin should be inserted into Annex III to Regulation (EEC) No 2377/90; whereas it is necessary to define the duration of the provisional maximum residue limits;

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 authorizations to place the veterinary medicinal products concerned on the market which have been granted in accordance with Council Directive 81/851/EEC (3), as amended by Directive 90/676/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 Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Veterinary Medicinal Products Sector,

HAS ADOPTED THIS REGULATION:

Article 1

Annex III of Regulation (EEC) No 2377/90 is hereby amended as set out in the Annex hereto.

Article 2

This Regulation 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, 27 October 1992. For the Commission

Martin BANGEMANN

Vice-President

(1) OJ No L 224, 18. 8. 1990, p. 1. (2) OJ No L 83, 28. 3. 1992, p. 14. (3) OJ No L 317, 6. 11. 1981, p. 1. (4) OJ No L 373, 31. 12. 1990, p. 15.

ANNEX

Annex III is modified as follows:

I. Under 1.2.3. Macrolides the following heading is inserted:

Pharmacologically active substances Marker residue Animal species MRLs Target tissues Other provisions '1.2.3.2. Tylosin Tylosin bovine

porcine

poultry 100 mg/kg muscle

liver

kidney Provisional MRLs expire on 1. 7. 1995.' bovine 50 mg/kg milk

II. Under 2.1.1. Benzimidazoles and pro-benzimidazoles the following are inserted:

Pharmacologically active substances Marker residue Animal species MRLs Target tissues Other provisions '2.1.1.4. Albendazole Sum of albendazole and metabolites which are measured as 2-amino-benzimidazole sulphone bovine

ovine 100 mg/kg

500 mg/kg

1 000 mg/kg muscle

fat

milk

kidney

liver Provisional MRLs expire on 1. 1. 1996. 2.1.1.5. Thiabendazole Sum of thiabendazole and 5-hydroxythiabendazole bovine

ovine

caprine 100 mg/kg muscle

liver

kidney

fat

milk Provisional MRLs expire on 1. 1. 1996.'

III. The following heading is added:

'2.2. Agents acting against ectoparasites

Pharmacologically active substances Marker residue Animal species MRLs Target tissues Other provisions 2.2.1. Amitraz Sum of amitraz and metabolites which are measured as 2.4-dimethylaniline porcine 50 mg/kg 200 mg/kg muscle kidney, liver Provisional MRLs expire on 1. 7. 1994.'