Commission Regulation (EC) No 2701/94 of 7 November 1994 amending Annexes I, II, III and IV 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: 1994-11-07
Institutions: European Commission
Subjects: animal product, food inspection, health control, medicinal product, veterinary medicinal product, waste








L_1994287EN.01000701.xml










8.11.1994   


EN


Official Journal of the European Communities


L 287/7





COMMISSION REGULATION (EC) NO 2701/94
of 7 November 1994
amending Annexes I, II, III and IV 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 1430/94 (2), and in particular Articles 6, 7 and 8 thereof,
Whereas, since the adoption of the Regulation, the Annexes have been amended a number of times; whereas, by reason of their number, their complexity and their dispersal among various Official Journals of the European Communities, the texts are difficult to use and thus lack the clarity which should be an essential feature of all legislation; whereas, they should therefore be consolidated; whereas on the same occasion the name or chemical description of some compounds should be rectified or made more precise and certain material errors should be corrected;
Whereas the measures provided for in this Regulation are in accordance with the opinion of the Committee for the adaptation to technical progress of directives on the removal of technical barriers to trade in the veterinary medicinal products sector,
HAS ADOPTED THIS REGULATION:
Article 1
Annexes I, II, III and IV 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, 7 November 1994.


For the Commission

Martin BANGEMANN

Member of the Commission





(1)  OJ No L 224, 18. 8. 1990, p. 1.

(2)  OJ No L 156, 23. 6. 1994, p. 6.


ANNEX
‘
ANNEX I
List of pharmacologically active substances for which maximum residue limits have been fixed






1.


Anti-infectious agents






1.1.


Chemotherapeutics






1.1.1.


Sulfonamides










Pharmacologically active substance(s)


Marker residue


Animal species


MRLs


Target tissues


Other provisions




All substances belonging to the sulfonamide group


Parent drug


All food producing species


100 μg/kg


Muscle, liver, kidney, fat


The combined total residues of all substances within the sulfonamide group should not exceed 100 μg/kg


















1.2.


Antibiotics






1.2.1.


Penicillins










Pharmacologically active substance(s)


Marker residue


Animal species


MRLs


Target tissues


Other provisions










1.2.1.1.


Benzylpenicillin






Benzylpenicillin


All food producing species


50 μg/kg


Muscle, liver, kidney, fat


 




4 μg/kg


Milk


 










1.2.1.2.


Ampicillin






Ampicillin


All food producing species


50 μg/kg


Muscle, liver, kidney, fat


 




4 μg/kg


Milk


 










1.2.1.3.


Amoxicillin






Amoxicillin


All food producing species


50 μg/kg


Muscle, liver, kidney, fat


 




4 μg/kg


Milk


 










1.2.1.4.


Oxacillin






Oxacillin


All food producing species


300 μg/kg


Muscle, liver, kidney, fat


 




30 μg/kg


Milk


 










1.2.1.5.


Cloxacillin






Cloxacillin


All food producing species


300 μg/kg


Muscle, liver, kidney, fat


 




30 μg/kg


Milk


 










1.2.1.6.


Dicloxacillin






Dicloxacillin


All food producing species


300 μg/kg


Muscle, liver, kidney, fat


 




30 μg/kg


Milk


 














1.2.2.


Cephalosporins










Pharmacologically active substance(s)


Marker residue


Animal species


MRLs


Target tissues


Other provisions










1.2.2.1.


Cefquinome






Cefquinome


Bovine


200 μg/kg


Kidney


 




100 μg/kg


Liver


 




50 μg/kg


Muscle


 




50 μg/kg


Fat


 














1.2.3.


Quinolones










Pharmacologically active substance(s)


Marker residue


Animal species


MRLs


Target tissues


Other provisions










1.2.3.1.


Enrofloxacin






Sum of enrofloxacin and ciprofloxacin


Bovine, porcine, poultry


30 μg/kg


Muscle, liver, kidney


 














1.2.4.


Macrolides










Pharmacologically active substance(s)


Marker residue


Animal species


MRLs


Target tissues


Other provisions




1.2.4.1. Tilmicosin


Tilmicosin


Bovine


1 000 μg/kg


Liver, kidney


 




50 μg/kg


Muscle, fat


 






















2.


Antiparasitic agents






2.1.


Agents acting against endoparasites






2.1.1.


Avermectins










Pharmacologically active substance(s)


Marker residue


Animal species


MRLs


Target tissues


Other provisions










2.1.1.1.


Ivermectin






22,23- Dihydroavermectin B1a


Bovine


100 μg/kg


Liver


 




40 μg/kg


Fat


 




Porcine


15 μg/kg


Liver


 




Ovine


20 μg/kg


Fat


 




Equidae










2.1.1.2.


Abamectin






Avermectin B1a


Bovine


20 μg/kg


Liver


 




10 μg/kg


Fat


 










2.1.1.3.


Doramectin






Doramectin


Bovine


15 μg/kg


Liver


 




25 μg/kg


Fat


 














2.1.2


Salicylanilides










Pharmacologically active substance(s)


Marker residue


Animal species


MRLs


Target tissues


Other provisions










2.1.2.1.


Closantel






Closantel


Bovine


1 000 μg/kg


Muscle, liver


 




3 000 μg/kg


Kidney, fat


 




Ovine


1 500 μg/kg


Muscle, liver


 




5 000 μg/kg


Kidney, fat


 




2 000 μg/kg


 


 


















ANNEX II
List of substances not subject to maximum residue limits






1.


Inorganic chemicals







Pharmacologically active substance(s)


Animal species


Other provisions










1.1.


Hydrogen peroxide






Fish


 










1.2.


Sulphur






Bovine


 




Porcine


 




Ovine


 




Caprine


 




Equidae


 










1.3.


Iodine and iodine inorganic compounds including:






—


Sodium and potassium — iodide










—


Sodium and potassium — iodate










—


Iodophors including polyvinylpyrrolidone — iodine










All food producing species


 










1.4.


Sodium chlorite






Bovine


For tropical use only














2.


Organic compounds







Pharmacologically active substance(s)


Animal species


Others provisions










2.1.


Etiproston tromethamine






Bovine


 




Porcine


 










2.2.


Ketanserin tartrate






Equidae


 










2.3.


Fertirelin acetate






Bovine


 










2.4.


Human menopausal urinary gonadotrophin






Bovine


 










2.5.


Lactic acid






All food producing species


 










2.6.


Melatonin






Ovine


 




Caprine


 










2.7.


Iodine organic compounds






—


Iodoform










All food producing species


 










2.8.


Acetyl cysteine






All food producing species


 










ANNEX III
List of pharmacologically active substances used in veterinary medicinal products for which provisional maximum residue limits have been fixed






1.


Anti-infectious agents






1.1.


Chemotherapeutics






1.1.1.


Sulfonamides










Pharmacologically active substance(s)


Marker residue


Animal species


MRLs


Target tissues


Other provisions




All substances belonging to the sulfonamide group


Parent drug


Bovine, ovine, caprine


100 μg/kg


Milk


Provisional MRL expires on 1. 1. 1996. The combined total residues of all substances within the sulfonamide group should not exceed 100 μg/kg














1.1.2.


Diamino pyrimidine derivates










Pharmacologically active substance(s)


Marker residue


Animal species


MRLs


Target tissues


Other provisions










1.1.2.1.


Trimethoprim






Trimethoprim


All food producing species


50 μg/kg


Muscle, liver, kidney, fat, milk


Provisional MRL expires on 1. 1. 1996














1.1.3.


Nitrofurans










Pharmacologically active substance(s)


Marker residue


Animal species


MRLs


Target tissues


Other provisions










1.1.3.1.


Furazolidone






All residues with intact 5-nitro structure


All food producing species


5 μg/kg


Muscle, liver, kidney, fat


Provisional MRL expires on 1. 7. 1995














1.1.4.


Nitroimidazoles










Pharmacologically active substance(s)


Marker residue


Animal species


MRLs


Target tissues


Other provisions










1.1.4.1.


Dimetridazole






All residues with intact nitroimidazole structure


All food producing species


10 μg/kg


Muscle, liver, kidney, fat


Provisional MRL expires on 1. 1. 1995


















1.2.


Antibiotics






1.2.1.


Tetracyclines










Pharmacologically active substance(s)


Marker residue


Animal species


MRLs


Target tissues


Other provisions




All substances belonging to the tetracycline group


Parent drug


All food producing species


600 μg/kg


Kidney


Provisional MRLs expire on 1. 1. 1996. The combined total residues of all substances within the tetracycline group should not exceed the limits indicated




300 μg/kg


Liver




200 μg/kg


Eggs




100 μg/kg


Muscle




100 μg/kg


Milk














1.2.2.


Macrolides










Pharmacologically active substance(s)


Marker residue


Animal species


MRLs


Target tissues


Other provisions










1.2.2.1.


Spiramycin






Spiramycin


Bovine, porcine


300 μg/kg


Liver,


Provisional MRLs expire on 1. 7. 1995. The MRLs for liver, kidney and muscle apply to both the bovine and porcine species




200 μg/kg


Kidney,




50 μg/kg


Muscle




Bovine


150 μg/kg


Milk




1.2.2.2.


Tylosin


Bovine


100 μg/kg


Muscle, liver, kidney


Provisional MRLs expire on 1. 7. 1995




Porcine


 


 




Poultry


 


 




Bovine


50 μg/kg


Milk














1.2.3.


Thiamphenicol and related compounds










Pharmacologically active substance(s)


Market residue


Animal species


MRLs


Target tissues


Other provisions










1.2.3.1.


Thiamphenicol






Thiamphenicol


Bovine
Poultry


40 μg/kg


Muscle, liver, kidney, fat


Provisional MRL expires on 1. 1. 1996






















2.


Antiparasitic agents






2.1.


Agents acting against endo-parasites






2.1.1.


Benzimidazoles and pro-benzimidazoles










Pharmacologically active substance(s)


Marker residue


Animal species


MRLs


Target tissues


Other provisions










2.1.1.1.


Febantel






Combined residues of oxfendazole, oxfendazole sulfone and fenbendazole


All food producing species


1 000 μg/kg


Liver


Provisional MRLs expire on 1. 7. 1995. The MRLs cover all residues of febantel, fenbendazole and oxfendazole




10 μg/kg


Muscle, kidney, fat




10 μg/kg


Milk










2.1.1.2.


Fenbendazole






Combined residues of oxfendazole, oxfendazole sulfone and fenbendazole


All food producing species


1 000 μg/kg


Liver


Provisional MRLs expire on 1. 7. 1995. The MRLs cover all residues of febantel, fenbendazole and oxfendazole




10 μg/kg


Muscle, kidney, fat




10 μg/kg


Milk










2.1.1.3.


Oxfendazole






Combined residues of oxfendazole, oxfendazole sulfone and fenbendazole


All food producing species


1 000 μg/kg


Liver


Provisional MRLs expire on 1. 7. 1995. The MRLs cover all residues of febantel, fenbendazole and oxfendazole




10 μg/kg


Muscle, kidney, fat




10 μg/kg


Milk










2.1.1.4.


Albendazole






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


Bovine


100 μg/kg


Muscle, fat, milk,


Provisional MRLs expire on 1. 1. 1996




Ovine


500 μg/kg


Kidney




 


1 000 μg/kg


Liver










2.1.1.5.


Thiabendazole






Sum of thiabendazole and 5-hydroxythiabendazole


Bovine


100 μg/kg


Muscle, liver, kidney, fat, milk


Provisional MRLs expire on 1. 1. 1996




Ovine


 




Caprine


 










2.1.1.6.


Triclabendazole






Sum of extractable residues that may be oxidized to ketotriclabendazole


Bovine


150 μg/kg


Muscle, liver, kidney


Provisional MRLs expire on 1. 7. 1995




Ovine


50 μg/kg


Fat










2.1.1.7.


Flubendazole






Flubendazole


Poultry


500 μg/kg


Liver,


Provisional MRLs expire on 1. 1. 1996




Game birds


200 μg/kg


Muscle,




400 μg/kg


Eggs




Porcine


10 μg/kg


Muscle, liver, kidney, fat










2.1.1.8.


Oxibendazole






Oxibendazole


Bovine
Ovine


100 μg/kg


Muscle, liver, kidney, fat


Provisional MRLs expire on 1. 1. 1996




 


50 μg/kg


Milk




Porcine
Equidae


100 μg/kg


Muscle, liver, kidney, fat














2.1.2.


Tetra-hydro-imidazoles (imidazolthiazoles)










Pharmacologically active substance(s)


Marker residue


Animal species


MRLs


Target tissues


Other provisions










2.1.2.1.


Levamisole






Levamisole


All food producing species


10 μg/kg


Musle, liver, kidney, fat, milk


Provisional MRL expires on 1. 1. 1995


















2.2.


Agents acting against ectoparasites










Pharmacologically active substance(s)


Marker residue


Animal species


MRLs


Target tissues


Other provisions










2.2.1.


Amitraz






Sum of amitraz and metabolites which are measured as 2,4-dimethylaniline


Porcine


50 μg/kg


Muscle


Provisional MRLs expire on 1. 7. 1996.




200 μg/kg


Kidney, liver


















3.


Agents acting on the nervous system






3.1.


Agents acting on the central nervous system






3.1.1.


Butyrophenone tranquilizers










Pharmacologically active substance(s)


Marker residue


Animal species


MRLs


Target tissues


Other provisions










3.1.1.1.


Azaperone






Azaperol


All food producing species


100 μg/kg


Kidney


Provisional MRLs expire on 1. 1. 1996




50 μg/kg1


Liver, muscle, fat


















3.2.


Agents acting on the autonomic nervous system






3.2.1.


Anti-adrenergics










Pharmacologically active substance(s)


Marker residue


Animal species


MRLs


Target tissues


Other provisions










3.2.1.1.


Carazolol






Carazolol


All food producing species


30 μg/kg


Liver


Provisional MRLs expire on 1. 7. 1995




5 μg/kg


Kidney, muscle, fat


















ANNEX IV
List of pharmacologically active substances for which no maximum levels can be fixed






1.


Nitrofurans, except furazolidone (see Annex III)










2.


Ronidazole










3.


Dapsone










4.


Chloramphenicol




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