Commission Regulation (EC) No 613/98
of 18 March 1998
amending Annexes II, III and IV of 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,
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 potassium nitrate, potassium dl-aspartate, potassium glucuronate and potassium glycerophosphate should be inserted into Annex II to Regulation (EEC) No 2377/90;
Whereas, in order to allow for the completion of scientific studies, florfenicol and moxidectin should be inserted into Annex III to Regulation (EEC) No 2377/90;
Whereas, 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 of Regulation (EEC) No 2377/90 should be extended for albendazole sulphoxide and carprofen;
Whereas it appears that maximum residue limits cannot be established for metronidazole because residues, at whatever limit, in foodstuffs of animal origin might constitute a hazard to the health of the consumer, whereas it should be inserted into Annex IV to Regulation (EEC) No 2377/90;
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 II, III and IV of 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, 18 March 1998.
For the Commission
Martin Bangemann
Member of the Commission
ANNEX
- A.
Annex II is modified as follows:
- 1.
Inorganic chemicals
Pharmacologically active substances(s)
Animal species
Other provisions
‘Potassium nitrate
All food producing species
Potassium DL-aspartate
All food producing species
Potassium glucuronate
All food producing species
Potassium glycerophosphate
All food producing species’
- 1.
- B.
Annex III is modified as follows:
- 1.
Anti-infectious agents
- 1.2.
Antibiotics
- 1.2.11.
Florfenicol and related compounds
Pharmacologically active substance
Marker residue
Animal species
MRLs
Target tissues
Other provisions
‘Florfenicol
Sum of florfenicol and its metabolites measured as florfenicol-amine
Fish
1 000 µg/kg
Muscle and skin in natural proportions
Provisional MRLs expire on 1.7.2001’
- 1.2.11.
- 1.2.
- 2.
Antiparasitic agents
- 2.1.
Agents acting against endoparasites
- 2.1.1.
Benzimidazoles and pro-benzimidazoles
Pharmacologically active substance
Marker residue
Animal species
MRLs
Target tissues
Other provisions
‘Albendazole sulphoxide
Sum of albendazole, albendazole sulphoxide, albendazole sulphone and albendazole 2-amino sulphone, expressed as albendazole
Bovine, ovine, pheasant
1 000 µg/kg
Liver
Provisional MRLs expire on 1.1.2000’
500 µg/kg
Kidney
100 µg/kg
Muscle, fat
Bovine, ovine
100 µg/kg
Milk
- 2.1.1.
- 2.3.
Agents acting against endo- and ectoparasites
- 2.3.1.
Avermectins
Pharmacologically active substance
Marker residue
Animal species
MRLs
Target tissues
Other provisions
‘Moxidectin
Moxidectin
Equidae
50 µg/kg
Muscle
Provisional MRLs expire on 1.1.2000’
500 µg/kg
Fat
100 µg/kg
Liver
50 µg/kg
kidney
- 2.3.1.
- 2.1.
- 4.
Anti-inflammatory agents
- 4.1.
Nonsteroidal anti-inflammatory agents
- 4.1.1.
Arylpropionic acid derivative
Pharmacologically active substance
Marker residue
Animal species
MRLs
Target tissues
Other provisions
‘Carprofen
Carprofen
Bovine
1 000 µg/kg
Liver, kidney
Provisional MRLs expire on 1.1.2000’
500 µg/kg
Muscle, fat
Equidae
1 000 µg/kg
Liver, kidney
50 µg/kg
Muscle
100 µg/kg
Fat
- 4.1.1.
- 4.1.
- 1.
- C.
Annex IV is modified as follows:
List of pharmacologically active substances for which no maximum levels can be fixed
‘Metronidazole.’