Annexes I, II and III of Regulation (EEC) No 2377/90 are hereby amended as set out in the Annex hereto.
Commission Regulation (EC) No 749/97 of 25 April 1997 amending Annexes I, II and III 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
Commission Regulation (EC) No 749/97 of 25 April 1997 amending Annexes I, II and III 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
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 748/97(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 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, difloxacin and vedaprofen should be inserted into Annex I to Regulation (EEC) No 2377/90;
Whereas thiomersal and timerfonate should be inserted into Annex II to Regulation (EEC) No 2377/90;
Whereas, in order to allow for the completion of scientific studies, clavulanic acid should be inserted into Annex III to Regulation (EEC) No 2377/90;
Whereas, in order to allow for the completion of the scientific studies in progress, 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 dexamethasone;
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 authorisations 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
Article 2
This Regulation shall enter into force on the sixtieth 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, 25 April 1997.
For the Commission
Martin Bangemann
Member of the Commission
ANNEX
The Annexes to Regulation (EEC) No 2377/90 are amended as follows:
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Annex I is amended as follows:
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Anti-infectious agents
-
Antibiotics
-
Quinolones
Pharmacologically active substance
Marker residue
Animal species
MRLs
Target tissues
Other provisions
Difloxacin
Difloxacin
Chicken, turkey
1 900 μg/kg
Liver
600 μg/kg
Kidney
300 μg/kg
Muscle
400 μg/kg
Skin/fat’
-
-
-
Anti-inflammatory agents
-
Nonsteroidal anti-inflammatory agents
-
Arylpropionic acid derivative
Pharmacologically active substance
Marker residue
Animal species
MRLs
Target tissues
Other provisions
Vedaprofen
Vedaprofen
Equidae
1 000 μg/kg
Kidney
100 μg/kg
Liver
50 μg/kg
Muscle
20 μg/kg
Fat’
-
-
-
-
Annex II is amended as follows:
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Organic compounds
Pharmacologically active substance(s)
Animal species
Other provisions
Thiomersal
All food producing species
For use only as preservatives in multidose vaccines at a concentration not exceeding 0,02 %
Timerfonate
All food producing species
For use only as preservatives in multidose vaccines at a concentration not exceeding 0,02 %’
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-
Annex III is amended as follows:
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Anti-infectious agents
-
Antibiotics
-
Beta-lactamase inhibitors
Pharmacologically active substance(s)
Marker residue
Animal species
MRLs
Target tissues
Other provisions
Clavulanic acid
Clavulanic acid
Bovine, ovine, porcine
200 μg/kg
Muscle, liver, kidney, fat
Provisional MRLs expire on 1. 7. 1999 ’
Bovine, ovine
200 μg/kg
Milk
-
-
-
Corticoids
-
Glucocorticoids
Pharmacologically active substance(s)
Marker residue
Animal species
MRLs
Target tissues
Other provisions
examethasone
Dexamethasone
Bovine, porcine, equidae
2,5 μg/kg
Liver
Provisional MRLs expire on 1. 7. 1997 ’
0,5 μg/kg
Muscle, kidney
Bovine
0,3 μg/kg
Milk
-
-