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Document 32012R1186

    Commission Implementing Regulation (EU) No 1186/2012 of 11 December 2012 amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance phoxim Text with EEA relevance

    IO L 338, 12.12.2012, p. 20–22 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    ⏵Foilsíodh an doiciméad seo in eagrán speisialta (HR)

    Legal status of the document In force

    ELI: http://data.europa.eu/eli/reg_impl/2012/1186/oj

    Date of document:
    11/12/2012
    Date of effect:
    15/12/2012; Teacht i bhfeidhm Dáta foilsithe +3 Féach Airt. 2
    Date of effect:
    13/02/2013; Cur i bhfeidhm Féach Airt. 2
    Date of end of validity:
    No end date
    Author:
    An Coimisiún Eorpach
    Responsible body:
    Directorate-General for Health and Food Safety
    Form:
    Rialachán cur chun feidhme
    Additional information:
    Ábharthacht maidir le LEE
    Treaty:
    An Conradh ar Fheidhmiú an Aontais Eorpaigh
    Legal basis:
    Link
    Link
    Link
    Select all documents mentioning this document
    Modifies:
    Relation Act Comment Subdivision concerned From To
    Modifies 32010R0037 Leasú iarscríbhinn 13/02/2013
    Link

    12.12.2012   

    EN

    Official Journal of the European Union

    L 338/20

    COMMISSION IMPLEMENTING REGULATION (EU) No 1186/2012

    of 11 December 2012

    amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance phoxim

    (Text with EEA relevance)

    THE EUROPEAN COMMISSION,

    Having regard to the Treaty on the Functioning of the European Union,

    Having regard to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (1), and in particular Article 14 in conjunction with Article 17 thereof,

    Having regard to the opinion of the European Medicines Agency formulated by the Committee for Medicinal Products for Veterinary Use,

    Whereas:

    (1)

    The maximum residue limit (‘MRL’) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry should be established in accordance with Regulation (EC) No 470/2009.

    (2)

    Pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin are set out in the Annex to Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (2).

    (3)

    Phoxim is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for ovine species, applicable to muscle, fat and kidney, for porcine species, applicable to muscle, skin and fat, liver and kidney and for chicken, applicable to muscle, skin and fat, liver, kidney and eggs, excluding animals producing milk for human consumption.

    (4)

    An application for the extension of the existing entry for phoxim to include bovine species has been submitted to the European Medicines Agency.

    (5)

    According to Article 5 of Regulation (EC) No 470/2009 the European Medicines Agency is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species. The Committee for Medicinal Products for Veterinary Use recommended establishing a MRL for phoxim for bovine species applicable to muscle, fat, liver and kidney, excluding animals producing milk for human consumption, and the extrapolation of the MRLs for phoxim from ovine, bovine and porcine species, and chicken to all food-producing species except fin fish, applicable to muscle, fat, liver, kidney and eggs, excluding animals producing milk for human consumption.

    (6)

    The entry for phoxim in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include all food-producing species except fin fish.

    (7)

    It is appropriate to provide for a reasonable period of time for the stakeholders concerned to take measures that may be required to comply with the newly set MRL.

    (8)

    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

    The Annex to Regulation (EU) No 37/2010 is amended as set out in the Annex to this Regulation.

    Article 2

    This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

    It shall apply from 13 February 2013.

    This Regulation shall be binding in its entirety and directly applicable in all Member States.

    Done at Brussels, 11 December 2012.

    For the Commission

    The President

    José Manuel BARROSO

    (1)   OJ L 152, 16.6.2009, p. 11.

    (2)   OJ L 15, 20.1.2010, p. 1.

    ANNEX

    The entry corresponding to phoxim in Table 1 of the Annex to Regulation (EU) No 37/2010 is replaced by the following:

    Pharmacologically active substance

    Marker residue

    Animal Species

    MRL

    Target Tissues

    Other Provisions (according to Article 14(7) of Regulation (EC) No 470/2009)

    Therapeutic classification

    ‘Phoxim

    Phoxim

    All food-producing species except fin fish.

    25  μg/kg

    Muscle

    For porcine and poultry species the fat MRL relates to “skin and fat in natural proportions”.

    Not for use in animals from which milk is produced for human consumption.

    Antiparasitic agents/Agents against ectoparasites.’

    550  μg/kg

    Fat

    50  μg/kg

    Liver

    30  μg/kg

    Kidney

    60  μg/kg

    Eggs
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