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Document 31996R1147

    Commission Regulation (EC) No 1147/96 of 25 June 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 (Text with EEA relevance)

    OJ L 151, 26.6.1996, p. 26–29 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)

    This document has been published in a special edition(s) (CS, ET, LV, LT, HU, MT, PL, SK, SL, BG, RO)

    Legal status of the document No longer in force, Date of end of validity: 05/07/2009; Implicitly repealed by 32009R0470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/1996/1147/oj

    26.6.1996   

    EN

    Official Journal of the European Communities

    L 151/26


    COMMISSION REGULATION (EC) No 1147/96

    of 25 June 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

    (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 0000/96 (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 propane, n-butane, isobutane, papaverine, polyethylene glycols (molecular weight ranging from 200 to 10 000), policresulen, magnesium and its compounds, papain and phenol should be inserted into Annex II to Regulation (EEC) No 2377/90;

    Whereas, in order to allow for the completion of scientific studies, clorsulon and vedaprofen 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 the 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, 25 June 1996.

    For the Commission

    Martin BANGEMANN

    Member of the Commission


    (1)  OJ No L 224, 18. 8. 1990, p. 1.

    (2)  See page 6 of this Official Journal.

    (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 modified as follows:

    1.

    Inorganic chemicals

    Pharmacologically active substance(s)

    Animal species

    Other provisions

    1.9.

    Magnesium

    All food producing species

     

    1.10.

    Magnesium sulphate

    All food producing species

     

    1.11.

    Magnesium hydroxide

    All food producing species

     

    1.12.

    Magnesium stearate

    All food producing species

     

    1.13.

    Magnesium glutamate

    All food producing species

     

    1.14.

    Magnesium orotate

    All food producing species

     

    1.15.

    Magnesium aluminium silicate

    All food producing species

     

    1.16.

    Magnesium oxide

    All food producing species

     

    1.17.

    Magnesium carbonate

    All food producing species

     

    1.18.

    Magnesium phosphate

    All food producing species

     

    1.19.

    Magnesium glycerophosphate

    All food producing species

     

    1.20.

    Magnesium aspartate

    All food producing species

     

    1.21.

    Magnesium citrate

    AH food producing species

     

    1.22.

    Magnesium acetate

    All food producing species

     

    1.23.

    Magnesium trisilicate

    All food producing species’

     

    2.

    Organic compounds

    Pharmacologically active substance(s)

    Animal species

    Other provisions

    2.37.

    Propane

    All food producing species

     

    2.38.

    n-butane

    All food producing species

     

    2.39.

    Isobutane

    All food producing species

     

    2.40.

    Phenol

    All food producing species

     

    2.41.

    Papaverine

    Bovine

    Newborn calves only

    2.42.

    Policresulen

    All food producing species

    For topical use only’

    2.43.

    Papain

    All food producing species

     

    3.

    Substances generally recognized as safe

    Pharmacologically active substance(s)

    Animal species

    Other provisions

    ‘3.62.

    Polyethylene glycols (molecular weight ranging from 200 to 10 000)

    All food producing species’

     

    B.

    Annex III is modified as follows:

    1.

    Anti-infectious agents

    1.1.

    Chemotherapeutics

    1.1.5.

    Benzenesulphonamides

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘1.1.5.1.

    Clorsulon

    Clorsulon

    Bovine

    50 μg/kg

    Muscle

    Provisional MRLs expire on 1 January 2000’

    150 μg/kg

    Liver

    400 μg/kg

    Kidney

    5.

    Anti-inflammatory agents

    5.1.

    Nonsteroidal anti-inflammatory agents

    5.1.1.

    Arylpropionic acid derivative

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘5.1.1.1.

    Vedaprofen

    Vedaprofen

    Horse

    100 μg/kg

    Liver

    Provisional MRLs expire on 1 January 1998’

    1 000 μg/kg

    Kidney

    50 μg/kg

    Muscle


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