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)
Corrected by
  • Corrigendum to 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, 301R0807R(01), May 16, 2001
  • Corrigendum to 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, 301R0807R(02), November 18, 2008
Commission Regulation (EC) No 807/2001of 25 April 2001amending 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 originOJ L 224, 18.8.1990, p. 1., as last amended by Commission Regulation (EC) No 750/2001OJ L 109, 19.4.2001, p. 35., 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/EECOJ L 317, 6.11.1981, p. 1., as last amended by Commission Directive 2000/37/ECOJ L 139, 10.6.2000, p. 25., 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.Anti-infectious agents 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
1500 μg/kg Kidney
150 μg/kg Milk
Porcine 100 μg/kg Muscle
50 μg/kg Skin and fat
500 μg/kg Liver
1500 μg/kg Kidney
Chicken 100 μg/kg Muscle
50 μg/kg Skin and fat
500 μg/kg Liver
1500 μg/kg Kidney
50 μg/kg Eggs"
2.Antiparasitic agents 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
1000 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: 2.Organic compounds
"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.Anti-infectious agents 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 1.1.2002For 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 1.1.2003Not 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.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
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"