Commission Regulation (EC) No 1433/96 of 23 July 1996 amending Annexes 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
1433/96 • 31996R1433
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24.7.1996
EN
Official Journal of the European Communities
L 184/21
COMMISSION REGULATION (EC) No 1433/96
of 23 July 1996
amending Annexes 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
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 1312/96 (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 hydrogen peroxide, peracetic acid, carbetocin, quillaia saponins, butyl 4-hydroxybenzoate, sodium butyl 4-hydroxybenzoate and sodium benzyl 4-hydroxybenzoate should be inserted into Annex II to Regulation (EEC) No 2377/90;
Whereas, in order to allow for the completion of scientific studies, baquiloprim 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 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, 23 July 1996.
For the Commission
Martin BANGEMANN
Member of the Commission
(1) OJ No L 224, 18. 8. 1990, p. 1.
(2) OJ No L 170, 9. 7. 1996, p. 8.
(3) OJ No L 317, 6. 11. 1981, p. 1.
(4) OJ No L 214, 24. 8. 1993, p. 31.
ANNEX
A.
Annex II is amended as follows:
1.
Inorganic chemicals
Pharmacologically active substance(s)
Animal species
Other provisions
‘1.1.
Hydrogen peroxide
All food-producing species’
2.
Organic compounds
Pharmacologically active substance(s)
Animal species
Other provisions
‘2.51.
Peracetic acid
All food-producing species
2.52.
Carbetocin
All mammalian food-producing species
2.53.
Quillaia saponins
All food-producing species
2.54.
Butyl 4-hydroxybenzoate
All food-producing species
2.55.
Sodium butyl 4-hydroxybenzoate
All food-producing species
2.56.
Sodium benzyl 4-hydroxybenzoate
All food-producing species’
B.
Annex III is amended as follows:
1.
Anti-infectious agents
1.1.
Chemotherapeutics
1.1.2.
Diamino pyrimidine derivatives
Pharmacologically active substance(s)
Marker residue
Animal species
MRLs
Target tissues
Other provisions
‘1.1.2.2.
Baquiloprim
Baquiloprim
Bovine
300 µg/kg
Liver
Provisional MRLs expire on 1.7.1998
150 µg/kg
Kidney
10 µg/kg
Fat
30 µg/kg
Milk
Porcine
50 µg/kg
Liver
Provisional MRLs expire on 1.7.1998’
50 µg/kg
Kidney
40 µg/kg
Fat and skin