2002R1181 — EN — 05.07.2002 — 000.002

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

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COMMISSION REGULATION (EC) No 1181/2002

of 1 July 2002

amending Annex I 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 veterinary medicinal products in foodstuffs of animal origin ( 1 ), as last amended by Commission Regulation (EC) No 869/2002 ( 2 ) and in particular Articles 6, 7 and 8 thereof, Whereas: (1) 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. (2) 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. (3) 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). (4) In view of the reduced availability of veterinary medicinal products for certain food-producing species ( 3 ), maximum residue limits may be established by methods of extrapolation from maximum residue limits set for other species on a strictly scientific basis. (5) 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. However, the liver and kidney are frequently removed from carcasses moving in international trade, and maximum residue limits should therefore also always be established for muscle or fat tissues. (6) 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. (7) Trimethoprim, Neomycin (including framycetin), Paromomycin, Spectinomycin, Colistin, Danofloxacin, Difloxacin, Enrofloxacin, Flumequine, Erythromycin, Tilmicosin, Tylosin, Florfenicol, Lincomycin and Oxyclozanide should be inserted into Annex I to Regulation (EEC) No 2377/90. (8) An adequate period 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 Directive 2001/82/EC ( 4 ) of the European Parliament and of the Council to take account of the provisions of this Regulation. (9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products, Whereas: HAS ADOPTED THE FOLLOWING REGULATION:

Article 1

Annex I 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 third day following its publication in the Official Journal of the European Communities.

It shall apply from the sixtieth day following its publication.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX

Annex I to Regulation (EEC No 2377/90 is amended as follows:

1. Anti-infectious agents

1.1. Chemotherapeutics

1.1.2. Diamino pyrimidine derivatives



‘Pharmacologically active substance Marker residue Animal species MRLs Target tissues Other provisions Trimethoprim Trimethoprim All food producing species except equidae 50 μg/kg Fat (1) Not for use in animals from which eggs are produced for human consumption 50 μg/kg Muscle (2) 50 μg/kg Liver 50 μg/kg Kidney 50 μg/kg Milk Equidae 100 μg/kg Muscle 100 μg/kg Fat 100 μg/kg Liver 100 μg/kg Kidney (1) ‘For porcine and poultry species this MRL relates to “‘skin and fat in natural proportions”‘. (2) ‘For fin fish this MRL relates to “‘muscle and skin in natural proportions”‘.’

1.2. Antibiotics

1.2.3. Quinolones



‘Pharmacologically active substance Marker residue Animal species MRLs Target tissues Other provisions Danofloxacin Danofloxacin ►C1 All food producing species except bovine, ovine, caprine, porcine and poultry ◄ 100 μg/kg Muscle (2) 50 μg/kg Fat (1) 200 μg/kg Liver 200 μg/kg Kidney Bovine, ovine, caprine 200 μg/kg Muscle 100 μg/kg Fat 400 μg/kg Liver 400 μg/kg Kidney 30 μg/kg Milk Poultry 200 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption 100 μg/kg Skin and fat 400 μg/kg Liver 400 μg/kg Kidney Difloxacin Difloxacin All food producing species except bovine, ovine, caprine and poultry 300 μg/kg Muscle (2) 100 μg/kg Fat 800 μg/kg Liver 600 μg/kg Kidney Bovine, ovine, caprine 400 μg/kg Muscle Not for use in animals from which milk is produced for human consumption 100 μg/kg Fat 1 400 μg/kg Liver 800 μg/kg Kidney Porcine 400 μg/kg Muscle 100 μg/kg Skin and fat 800 μg/kg Liver 800 μg/kg Kidney Poultry 300 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption 400 μg/kg Skin and fat 1 900 μg/kg Liver 600 μg/kg Kidney Enrofloxacin Sum of enrofloxacin and ciprofloxacin All food producing species except bovine, ovine, caprine, porcine, rabbits and poultry 100 μg/kg Muscle (2) 100 μg/kg Fat 200 μg/kg Liver 200 μg/kg Kidney Bovine, ovine, caprine 100 μg/kg Muscle 100 μg/kg Fat 300 μg/kg Liver 200 μg/kg Kidney 100 μg/kg Milk Porcine, rabbits 100 μg/kg Muscle 100 μg/kg Fat (1) 200 μg/kg Liver 300 μg/kg Kidney Poultry 100 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption 100 μg/kg Skin and fat 200 μg/kg Liver 300 μg/kg Kidney Flumequine Flumequine All food producing species except bovine, ovine, caprine, porcine, poultry and fin fish 200 μg/kg Muscle 250 μg/kg Fat 500 μg/kg Liver 1 000 μg/kg Kidney Bovine, porcine, ovine, caprine 200 μg/kg Muscle 300 μg/kg Fat (1) 500 μg/kg Liver 1 500 μg/kg Kidney 50 μg/kg Milk Poultry 400 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption 250 μg/kg Skin and fat 800 μg/kg Liver 1 000 μg/kg Kidney Fin fish 600 μg/kg Muscle and skin in natural proportion (1) ‘For fin fish this MRL relates to “‘muscle and skin in natural proportions”‘. (2) ‘For porcine species this MRL relates to “‘skin and fat in natural proportions”‘.’

1.2.4. Macrolides



‘Pharmacologically active substanceactiva Marker residue Animal species MRLs Target tissues Other provisions Erythromycin erythromicyin A All food producing species 200 μg/kg Muscle (1) 200 μg/kg Fat (2) 200 μg/kg Liver 200 μg/kg Kidney 40 μg/kg Milk 150 μg/kg Eggs Tilmicosin Tilmicosin All food producing species except poultry 50 μg/kg Muscle (1) 50 μg/kg Fat (2) 1 000 μg/kg Liver 1 000 μg/kg Kidney 50 μg/kg Milk Poultry 75 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption 75 μg/kg Sin and fat 1 000 μg/kg Liver 250 μg/kg Kidney Tylosin Tylosin A All food producing species 100 μg/kg Fat (3) 100 μg/kg Muscle (1) 100 μg/kg Liver 100 μg/kg Kidney 50 μg/kg Milk 200 μg/kg Eggs (1) ‘For fin fish this MRL relates to a “‘muscle and skin in natural proportions”‘. (2) ‘For procine species this MRL relates to “‘skin and fat in natural proportions”‘. (3) ‘For porcine and poultry species this MRL relates to “‘skin and fat in natural proportions”‘.’

1.2.5. Florfenicol and related compounds



‘Pharmacologically active substance Marker residue Animal species MRLs Target tissues Other provisions Florfenicol Sum of florfenicol and its metabolites measured as florfenicol-amine All food producing species except bovine, ovine, caprine, porcine, poultry and fin fish 100 μg/kg Muscle 200 μg/kg Fat 2 000 μg/kg Liver 300 μg/kg Kidney Bovine, ovine, caprine 200 μg/kg Muscle Not for use in animals from which milk is produced for human consumption ►C3 3 000 μg/kg ◄ ►C3 Liver ◄ 300 μg/kg Kidney Porcine 300 μg/kg Muscle 500 μg/kg Skin and fat 2 000 μg/kg Liver 500 μg/kg Kidney Poultry 100 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption 200 μg/kg Skin and fat 2 500 μg/kg Liver 750 μg/kg Kidney Fin fish 1 000 μg/kg Muscle and skin in natural proportions’

1.2.9. Lincosamides



‘Pharmacologically active substance Marker residue Animal species MRLs Target tissues Other provisions Lincomycin Lincomicyn All food producing species 50 μg/kg Fat (1) 100 μg/kg Muscle (2) 500 μg/kg Liver 1 500 μg/kg Kidney 150 μg/kg Milk 50 μg/kg Eggs (1) ‘For porcine and poultry species this MRL relates to “‘skin and fat in natural proportions”‘. (2) ‘For fin fish this MRL relates to “‘muscle and skin in natural proportions”‘.’

1.2.10. Aminoglycosides



‘Pharmacologically active substance Marker residue Animal species MRLs Target tissues Other provisions Neomycin (including framycetin) Neomycin B All food producing species 500 μg/kg Fat (1) 500 μg/kg Muscle (2) 500 μg/kg Liver 5 000 μg/kg Kidney 1 500 μg/kg Milk 500 μg/kg Eggs Paromomycin Paromomycin All food producing species 500 μg/kg Muscle (2) Not for use in animals from which milk or eggs are produced for human consumption 1 500 μg/kg Liver 1 500 μg/kg Kidney Spectinomycin Spectinomycin All food producing species except ovine 500 μg/kg Fat (1) Not for use in animals from which eggs are produced for human consumption 300 μg/kg Muscle (2) 1 000 μg/kg Liver 5 000 μg/kg Kidney 200 μg/kg Milk Ovine 300 μg/kg Muscle 500 μg/kg Fat 2 000 μg/kg Liver 5 000 μg/kg Kidney 200 μg/kg Milk (1) ‘For porcine and poultry species this MRL relates to “‘skin and fat in natural proportions”‘. (2) ‘For fin fish this MRL relates to “‘muscle and skin in natural proportions”‘.’

1.2.14. Polymyxins



‘Pharmacologically active substance Marker residue Animal species MRLs Target tissues Other provisions Colistin Colistin All food producing species 150 μg/kg Fat (1) 150 μg/kg Muscle (2) 150 μg/kg Liver 200 μg/kg Kidney 50 μg/kg Milk 300 μg/kg Eggs (1) ‘For porcine and poultry species this MRL relates to “‘skin and fat in natural proportions”‘. (2) ‘For fin fish this MRL relates to “‘muscle and skin in natural proportions”‘.’

2. Antiparasitic agents

2.1. Agents acting against endoparasites

2.1.4. Phenol derivatives including salicylanides



‘Pharmacologically active substance Marker residue Animal species MRLs Target tissues Other provisions Oxyclozanide Oxyclozanide Bovine 20 μg/kg Muscle 20 μg/kg Fat 500 μg/kg Liver 100 μg/kg Kidney 10 μg/kg Milk Ovine 20 μg/kg Muscle Not for use in animals from which milk is produced for human consumption 20 μg/kg Fat 500 μg/kg Liver 100 μg/kg Kidney’

( 1 ) OJ L 224, 18.8.1990, p. 1.

( 2 ) OJ L 137, 25.5.2002, p. 10.

( 3 ) Availability of veterinary medical products Communication from the Commission to the Council and the European Parliament COM(2000) 806 final.

( 4 ) OJ L 311, 28.11.2001, p. 1.