Commission Regulation (EC) No 1837/97

of 24 September 1997

amending Annexes I, 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

(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 origin1, as last amended by Commission Regulation (EC) No 749/972, 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 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, febentel, fenbendazole, oxfendazole and dexamethasone should be inserted into Annex I to Regulation (EEC) No 2377/90;

Whereas bromide, sodium salt should be inserted into Annex II to Regulation (EEC) No 2377/90;

Whereas, in order to allow for the completion of scientific studies, ceftiofur, danofloxacin and netobimin 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/EEC3, as last amended by Directive 93/40/EEC4, 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, 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, 24 September 1997.

For the Commission

Martin Bangemann

Member of the Commission

ANNEX

The Annexes to Regulation (EEC) No 2377/90 are hereby amended as follows:

  1. A.

    Annex I is amended as follows:

    1. 2.

      Antiparasitic agents

      1. 2.1.

        Agents acting against endoparasites

        1. 2.1.3.

          Benzimidazoles and pro-benzoimidazoles

          Pharmacologically active substance

          Marker residue

          Animal species

          MRLs

          Target tissues

          Other provisions

          ‘2.1.3.1.

          Febantel

          Sum of extractable residues which may be oxidized to oxfendazole sulphone

          Bovine, ovine, porcine, equidae

          50 μg/kg

          Muscle

          50 μg/kg

          Fat

          500 μg/kg

          Liver

          50 μg/kg

          Kidney

          Bovine, ovine

          10 μg/kg

          Milk

          2.1.3.2.

          Fenbendazole

          Sum of extractable residues which may be oxidized to oxfendazole sulphone

          Bovine, ovine, porcine, equidae

          50 μg/kg

          Muscle

          50 μg/kg

          Fat

          500 μg/kg

          Liver

          50 μg/kg

          Kidney

          Bovine, ovine

          10 μg/kg

          Milk

          2.1.3.3.

          Oxfendazole

          Sum of extractable residues which may be oxidized to oxfendazole sulphone

          Bovine, ovine, porcine, equidae

          50 μg/kg

          Muscle

          50 μg/kg

          Fat

          500 μg/kg

          Liver

          50 μg/kg

          Kidney

          Bovine, ovine

          10 μg/kg

          Milk’

    2. 5.

      Corticoids

      1. 5.1.

        Glucocorticoids

        Pharmacologically active substance

        Marker residue

        Animal species

        MRLs

        Target tissues

        Other provisions

        ‘5.1.1.

        Dexamethasone

        Dexamethasone

        Bovine, porcine, equidae

        0,75 μg/kg

        Muscle

        2,0 μg/kg

        Liver

        0,75 μg/kg

        Kidney

        Bovine

        0,3 μg/kg

        Milk’

  2. B.

    Annex II is amended as follows:

    1. 1.

      Inorganic compounds

      Pharmacologically active substance(s)

      Animal species

      Other provisions

      ‘1.29.

      Bromide, sodium salt

      All food producing mammals

      For topical use only’

  3. C.

    Annex III is amended as follows:

    1. 1.

      Anti-infectious agents

      1. 1.2.

        Antibiotics

        1. 1.2.4.

          Cephalosporins

          Pharmacologically active substance

          Marker residue

          Animal species

          MRLs

          Target tissues

          Other provisions

          ‘1.2.4.1.

          Ceftiofur

          Sum of all residues retaining the betalactam structure expressed as desfuroylceftiofur

          Bovine

          2 000 μg/kg

          Liver, kidney

          200 μg/kg

          Muscle

          600 μg/kg

          Fat

          100 μg/kg

          Milk

          Provisional MRLs expire on 1. 1. 1999’

          Porcine

          4 000 μg/kg

          Kidney

          3 000 μg/kg

          Liver

          500 μg/kg

          Muscle

          600 μg/kg

          Fat

      2. 1.2.6.

        Quinolones

        Pharmacologically active substance

        Marker residue

        Animal species

        MRLs

        Target tissues

        Other provisions

        ‘1.2.6.1.

        Danofloxacin

        Danofloxacin

        Bovine

        900 μg/kg

        Liver

        500 μg/kg

        Kidney

        300 μg/kg

        Muscle

        200 μg/kg

        Fat

        Provisional MRLs expire on 1. 1. 1999’

        Chicken

        1 200 μg/kg

        Liver, kidney

        600 μg/kg

        Skin + fat

        300 μg/kg

        Muscle

    2. 2.

      Antiparasitic agents

      1. 2.1.

        Agents acting against endo-parasites

        1. 2.1.1.

          Benzimidazoles and pro-benzoimidazoles

          Pharmacologically active substance

          Marker residue

          Animal species

          MRLs

          Target tissues

          Other provisions

          ‘2.1.1.9.

          Netobimin

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

          Bovine, ovine, caprine

          100 μg/kg

          Muscle, fat

          Provisional MRLs expire on 31. 7. 1999’

          1 000 μg/kg

          Liver

          500 μg/kg

          Kidney

          100 μg/kg

          Milk