Commission Regulation (EC) No 1837/97 of 24 September 1997 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)
Date: 1997-09-24
Institutions: European Commission
Subjects: animal product, food inspection, veterinary drug, veterinary legislation, waste








L_1997263EN.01000901.xml










25.9.1997   


EN


Official Journal of the European Communities


L 263/9





COMMISSION REGULATION (EC) No 1837/97
of 24 September 1997
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 (1), as last amended by Commission Regulation (EC) No 749/97 (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 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 carcasses 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, febentel, fenbendazole, oxfendazole and dexamethasone should be inserted into Annex I to Regulation (EEC) No 2377/90;
Whereas bromide, sodium salt should be inserted into Annex II to Regulation (EEC) No 2377/90;
Whereas, in order to allow for the completion of scientific studies, ceftiofur, danofloxacin and netobimin should be inserted into Annex III to Regulation (EEC) No 2377/90;
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 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 THIS 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 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, 24 September 1997.


For the Commission

Martin BANGEMANN

Member of the Commission





(1)  OJ L 224, 18. 8. 1990, p. 1.

(2)  OJ L 110, 26. 4. 1997, p. 24.

(3)  OJ L 317, 6. 11. 1981, p. 1.

(4)  OJ L 214, 24. 8. 1993, p. 31.


ANNEX
The Annexes to Regulation (EEC) No 2377/90 are hereby amended as follows:






A.


Annex I is amended as follows:






2.


Antiparasitic agents






2.1.


Agents acting against endoparasites






2.1.3.


Benzimidazoles and pro-benzoimidazoles










Pharmacologically active substance


Marker residue


Animal species


MRLs


Target tissues


Other provisions










‘2.1.3.1.


Febantel






Sum of extractable residues which may be oxidized to oxfendazole sulphone


Bovine, ovine, porcine, equidae


50 μg/kg


Muscle


 




50 μg/kg


Fat




500 μg/kg


Liver




50 μg/kg


Kidney




Bovine, ovine


10 μg/kg


Milk










2.1.3.2.


Fenbendazole






Sum of extractable residues which may be oxidized to oxfendazole sulphone


Bovine, ovine, porcine, equidae


50 μg/kg


Muscle


 




50 μg/kg


Fat




500 μg/kg


Liver




50 μg/kg


Kidney




Bovine, ovine


10 μg/kg


Milk










2.1.3.3.


Oxfendazole






Sum of extractable residues which may be oxidized to oxfendazole sulphone


Bovine, ovine, porcine, equidae


50 μg/kg


Muscle


 




50 μg/kg


Fat




500 μg/kg


Liver




50 μg/kg


Kidney




Bovine, ovine


10 μg/kg


Milk’






















5.


Corticoids






5.1.


Glucocorticoids










Pharmacologically active substance


Marker residue


Animal species


MRLs


Target tissues


Other provisions










‘5.1.1.


Dexamethasone






Dexamethasone


Bovine, porcine, equidae


0,75 μg/kg


Muscle


 




2,0 μg/kg


Liver




0,75 μg/kg


Kidney




Bovine


0,3 μg/kg


Milk’






















B.


Annex II is amended as follows:






1.


Inorganic compounds







Pharmacologically active substance(s)


Animal species


Other provisions










‘1.29.


Bromide, sodium salt






All food producing mammals


For topical use only’


















C.


Annex III is amended as follows:






1.


Anti-infectious agents






1.2.


Antibiotics






1.2.4.


Cephalosporins










Pharmacologically active substance


Marker residue


Animal species


MRLs


Target tissues


Other provisions










‘1.2.4.1.


Ceftiofur






Sum of all residues retaining the betalactam structure expressed as desfuroylceftiofur


Bovine


2 000 μg/kg


Liver, kidney


200 μg/kg




Muscle


600 μg/kg




Fat


100 μg/kg




Milk


Provisional MRLs expire on 1. 1. 1999’




Porcine


4 000 μg/kg


Kidney




3 000 μg/kg


Liver




500 μg/kg


Muscle




600 μg/kg


Fat


















1.2.6.


Quinolones










Pharmacologically active substance


Marker residue


Animal species


MRLs


Target tissues


Other provisions










‘1.2.6.1.


Danofloxacin






Danofloxacin


Bovine


900 μg/kg


Liver


500 μg/kg




Kidney


300 μg/kg




Muscle


200 μg/kg




Fat


Provisional MRLs expire on 1. 1. 1999’




Chicken


1 200 μg/kg


Liver, kidney




600 μg/kg


Skin + fat




300 μg/kg


Muscle


















2.


Antiparasitic agents






2.1.


Agents acting against endo-parasites






2.1.1.


Benzimidazoles and pro-benzoimidazoles










Pharmacologically active substance


Marker residue


Animal species


MRLs


Target tissues


Other provisions










‘2.1.1.9.


Netobimin






Sum of netobimin and albendazole and metabolites of albendazole measured as 2-amino-benzimidazole sulphone


Bovine, ovine, caprine


100 μg/kg


Muscle, fat


Provisional MRLs expire on 31. 7. 1999’




1 000 μg/kg


Liver




500 μg/kg


Kidney




100 μg/kg


Milk