Commission Regulation (EC) No 807/2001 of 25 April 2001 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)

COMMISSION REGULATION (EC) No 807/2001

of 25 April 2001

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,

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 ([^E0001]), as last amended by Commission Regulation (EC) No 750/2001 ([^E0002]), 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) 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.

• (5) 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.

• (6) Cefoperazone, cyhalothrin, lincomycin, nafcillin, netobimin, phoxim, tiamulin and cyfluthrin should be inserted into Annex I to Regulation (EEC) No 2377/90.

• (7) ‘Linear alkyl benzene sulphonic acids with alkyl chain lengths ranging from C9 to C13, containing less than 2,5 % of chains longer than C13’ should be inserted into Annex II to Regulation (EEC) No 2377/90.

• (8) 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 cefacetrile, oxolinic acid and permethrin.

• (9) 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 Council Directive 81/851/EEC ([^E0003]), as last amended by Commission Directive 2000/37/EC ([^E0004]), to take account of the provisions of this Regulation.

• (10) 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, II and III to Regulation (EEC) No 2377/90 are 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 60th day following its publication.

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

ANNEX

• A.Annex I to Regulation (EEC) No 2377/90 is amended as follows:

1.2.   Antibiotics 1.2.1.   Penicillins

‘Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Nafcillin Nafcillin Bovine 300 μg/kg Muscle For intramammary use only 300 μg/kg Fat 300 μg/kg Liver 300 μg/kg Kidney 30 μg/kg Milk’ 1.2.2.   Cephalosporins

‘Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Cefoperazone Cefoperazone Bovine 50 μg/kg Milk’ 1.2.8.   Pleuromutilines

‘Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Tiamulin Sum of metabolites that may be hydrolysed to 8-α-hydroxymutilin Turkey 100 μg/kg Muscle 100 μg/kg Skin and fat 300 μg/kg Liver’ 1.2.9.   Lincosamides

‘Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Lincomycin Lincomycin Ovine 100 μg/kg Muscle 50 μg/kg Fat 500 μg/kg Liver 1 500 μg/kg Kidney 150 μg/kg Milk Porcine 100 μg/kg Muscle 50 μg/kg Skin and fat 500 μg/kg Liver 1 500 μg/kg Kidney Chicken 100 μg/kg Muscle 50 μg/kg Skin and fat 500 μg/kg Liver 1 500 μg/kg Kidney 50 μg/kg Eggs’

2.1.   Agents acting against endoparasites 2.1.3.   Benzimidazoles and pro-benzimidazoles

‘Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Netobimin Sum of albendazole oxide, albendazole sulphone and albendazole 2-aminosulphone, expressed as albendazole Bovine, ovine 100 μg/kg Muscle For oral use only 100 μg/kg Fat 1 000 μg/kg Liver 500 μg/kg Kidney 100 μg/kg Milk’ 2.2.   Agents acting against ectoparasites 2.2.1.   Organophosphates

‘Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Phoxim Phoxim Ovine 50 μg/kg Muscle Not for use in animals from which milk is produced for human consumption 400 μg/kg Fat 50 μg/kg Kidney Porcine 20 μg/kg Muscle 700 μg/kg Skin and fat 20 μg/kg Liver 20 μg/kg Kidney’ 2.2.3.   Pyrethroids

‘Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Cyhalothrin Cyhalothrin (sum of isomers) Bovine 500 μg/kg Fat Further provisions in Council Directive 94/29/EC are to be observed 50 μg/kg Kidney 50 μg/kg Milk

Cyfluthrin Cyfluthrin (sum of isomers) Bovine, caprine 50 μg/kg Fat 10 μg/kg Liver 10 μg/kg Kidney 20 μg/kg Milk Further provisions in Council Directive 94/29/EC are to be observed’

• B.Annex II to Regulation (EEC) No 2377/90 is amended as follows:

‘Pharmacologically active substance(s) Animal species Other provisions Linear alkyl benzene sulphonic acids with alkyl chain lengths ranging from C9 to C13, containing less than 2,5 % of chains longer than C13 Bovine For topical use only’

• C.Annex III to Regulation (EEC) No 2377/90 is amended as follows:

1.2.   Antibiotics 1.2.4.   Cephalosporins

‘Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Cefacetrile Cefacetrile Bovine 125 μg/kg Milk Provisional MRLs expire on 1.1.2002 For intramammary use only’ 1.2.6.   Quinolones

‘Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Oxolinic acid Oxolinic acid Bovine 100 μg/kg Muscle Provisional MRLs expire on 1.1.2003 Not for use in animals from which milk is produced for human consumption 50 μg/kg Fat 150 μg/kg Liver 150 μg/kg Kidney Porcine 100 μg/kg Muscle 50 μg/kg Skin and fat 150 μg/kg Liver 150 μg/kg Kidney Chicken 100 μg/kg Muscle 50 μg/kg Skin and fat 150 μg/kg Liver 150 μg/kg Kidney 50 μg/kg Eggs Fin fish 300 μg/kg Muscle and skin in natural proportions’

2.2.   Agents acting against ectoparasites 2.2.3.   Pyrethroids

‘Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Permethrin Permethrin (sum of isomers) Chicken, porcine 50 μg/kg Muscle Provisional MRLs expire on 1.1.2003 500 μg/kg Skin and fat 50 μg/kg Liver 50 μg/kg Kidney Bovine, caprine 50 μg/kg Muscle Provisional MRLs expire on 1.1.2003 500 μg/kg Fat 50 μg/kg Liver 50 μg/kg Kidney 50 μg/kg Milk Further provisions in Commission Directive 98/82/EC are to be observed (OJ L 290, 29.10.1998, p. 25) Chicken 50 μg/kg Eggs Provisional MRLs expire on 1.1.2003’

[^E0001]: OJ L 224, 18.8.1990, p. 1.

[^E0002]: OJ L 109, 19.4.2001, p. 35.

[^E0003]: OJ L 317, 6.11.1981, p. 1.

[^E0004]: OJ L 139, 10.6.2000, p. 25.