Commission Regulation (EC) No 1838/97 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.01001401.xml










25.9.1997   


EN


Official Journal of the European Communities


L 263/14





COMMISSION REGULATION (EC) No 1838/97
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 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, baquiloprim, tylosin and tolfenamic acid should be inserted into Annex I to Regulation (EEC) No 2377/90;
Whereas bismuth subcarbonate, bismuth subgallate, bismuth subnitrate, bismuth subsalicylate, cloprostenol, r-cloprostenol and luprostiol should be inserted into Annex II to Regulation (EEC) No 2377/90;
Whereas, in order to allow for the completion of scientific studies, apramycin 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:






1.


Anti-infectious agents






1.1.


Chemotherapeutics






1.1.2.


Diamino pyrimidine derivates










Pharmacologically active substance


Marker residue


Animal species


MRLs


Target tissues


Other provisions










‘1.1.2.1.


Baquiloprim






Baquiloprim


Bovine


10 μg/kg


Fat


 




300 μg/kg


Liver




150 μg/kg


Kidney




30 μg/kg


Milk




Porcine


40 μg/kg


Skin + fat




50 μg/kg


Liver, kidney’


















1.2.


Antibiotics






1.2.4.


Macrolides










Pharmacologically active substance


Marker residue


Animal species


MRLs


Target tissues


Other provisions










‘1.2.4.3.


Tylosin






Tylosin A


Bovine


100 μg/kg


Muscle, fat, liver, kidney


 




50 μg/kg


Milk




Porcine


100 μg/kg


Muscle, skin + fat, liver, kidney




Poultry


100 μg/kg


Muscle, skin + fat, liver, kidney


Not for use in hens producing eggs for human consumption’






















4.


Anti-inflammatory agents






4.1.


Nonsteroidal anti-inflammatory agents






4.1.2.


Fenamate group derivatives










Pharmacologically active substance


Marker residue


Animal species


MRLs


Target tissues


Other provisions










‘4.1.2.1.


Tolfenamic acid






Tolfenamic acid


Bovine


50 μg/kg


Muscle


 




400 μg/kg


Liver




100 μg/kg


Kidney




50 μg/kg


Milk




Porcine


50 μg/kg


Muscle




400 μg/kg


Liver




100 μg/kg


Kidney’


























B.


Annex II is amended as follows:






1.


Inorganic compounds







Pharmacologically active substance(s)


Animal species


Other provisions










‘1.30.


Bismuth subcarbonate






All food-producing species


For oral use only










1.31.


Bismuth subgallate






All food-producing species


For oral use only










1.32.


Bismuth subnitrate






All food-producing species


For oral use only










1.33.


Bismuth subsalicylate






All food-producing species


For oral use only’














2.


Organic compounds







Pharmacologically active substance(s)


Animal species


Other provisions










‘2.79.


Cloprostenol






Bovine, porcine, equidae


 










2.80.


R-Cloprostenol






Bovine, porcine, equidae


 










2.81.


Luprostiol






All mammalian species’


 


















C.


Annex III is amended as follows:






1.


Anti-infectious agents






1.2.


Antibiotics






1.2.5.


Aminoglycosides










Pharmacologically active substance


Marker residue


Animal species


MRLs


Target tissues


Other provisions










‘1.2.5.7.


Apramycin






Apramycin


Bovine


1 000 μg/kg


Muscle, fat


For use in non-lactating cattle only Provisional MRLs expire on 1. 7. 1999




10 000 μg/kg


Liver




20 000 μg/kg


Kidney




Porcine


1 000 μg/kg


Muscle, skin + fat, liver


Provisional MRLs expire on 1. 7. 1999’




5 000 μg/kg


Kidney