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Document 31996R0281

Commission Regulation (EC) No 281/96 of 14 February 1996 amending Annexes I 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)

OJ L 37, 15.2.1996, p. 9–11 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)
Special edition in Czech: Chapter 03 Volume 018 P. 440 - 442
Special edition in Estonian: Chapter 03 Volume 018 P. 440 - 442
Special edition in Latvian: Chapter 03 Volume 018 P. 440 - 442
Special edition in Lithuanian: Chapter 03 Volume 018 P. 440 - 442
Special edition in Hungarian Chapter 03 Volume 018 P. 440 - 442
Special edition in Maltese: Chapter 03 Volume 018 P. 440 - 442
Special edition in Polish: Chapter 03 Volume 018 P. 440 - 442
Special edition in Slovak: Chapter 03 Volume 018 P. 440 - 442
Special edition in Slovene: Chapter 03 Volume 018 P. 440 - 442
Special edition in Bulgarian: Chapter 03 Volume 018 P. 150 - 152
Special edition in Romanian: Chapter 03 Volume 018 P. 150 - 152

Legal status of the document No longer in force, Date of end of validity: 05/07/2009; Implicitly repealed by 32009R0470

ELI: http://data.europa.eu/eli/reg/1996/281/oj

15.2.1996   

EN

Official Journal of the European Communities

L 37/9


COMMISSION REGULATION (EC) No 281/96

of 14 February 1996

amending Annexes I 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 2804/95 (2), and in particular Articles 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 level 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 tetracycline, oxytetracycline, chlortetracycline and all substances belonging to the sulfonamide group should be inserted into Annex I to Regulation (EEC) No 2377/90;

Whereas, in order to allow for the completion of scientific studies in progress, the duration of the validity of the provisional maximum residue limits previously defined in Annex III to Regulation (EEC) No 2377/90 should be extended for trimethoprim;

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 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 and III 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, 14 February 1996.

For the Commission

Martin BANGEMANN

Member of the Commission


(1)  OJ No L 224, 18. 8. 1990, p. 1.

(2)  OJ No L 291, 6. 12. 1995, 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 I is amended as follows:

1.

Anti-infectious agents

1.1.

Chemotherapeutics

1.1.1.

Sulfonamides

Pharmacologically active substance

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

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

1.2.

Antibiotics

1.2.6.

Tetracylines

Pharmacologically active substance

Marker residue

Animal Species

MRLs

Target Tissues

Other provisions

‘1.2.6.1.

Tetracycline

Sum of parent drug and its 4-epimer

All food producing species

600 μg/kg

Kidney

 

300 μg/kg

Liver

100 μg/kg

Muscle

100 μg/kg

Milk

200 μg/kg

Eggs

1.2.6.2.

Oxytetracycline

Sum of parent drug and its 4-epimer

All food producing species

600 μg/kg

Kidney

 

300 μg/kg

Liver

100 μg/kg

Muscle

100 μg/kg

Milk

200 μg/kg

Eggs

1.2.6.3.

Chlortetracycline

Sum of parent drug and its 4-epimer

All food producing species

600 μg/kg

Kidney

 

300 μg/kg

Liver

100 μg/kg

Muscle

100 μg/kg

Milk

200 μg/kg

Eggs’

B.

Annex III is amended as follows:

1.

Anti-infectious agents

1.1.

Chemotherapeutics

1.1.2.

Diamino pyrimidine derivates

Pharmacologically active substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘1.1.2.1.

Trirnethoprim

Trimethoprim

All food producing species

50 μg/kg

Muscle, liver, kidney, fat, milk

Provisional MRLs expire on 1 January 1998’


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