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(EU) No 681/2014:就碘醚柳胺(rafoxanide),修订(EU) No 37/2010(amending Regulation (EU) No 37/2010, as regards the substance ‘rafoxanide’)

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放大字体  缩小字体 2014-06-24 11:17:34  来源:EUROPE  浏览次数:2361
核心提示:2014年6月21日,欧盟发布委员会实施条例(EU) No 681/2014,设定药理学活性物质碘醚柳胺(rafoxanide)在牛和羊的乳汁中的临时最大残留限量为10 μg/kg,此临时MRL至2015年12月31日到期。
发布单位
EUROPEAN COMMISSION
EUROPEAN COMMISSION
发布文号 (EU) No 681/2014
发布日期 2014-06-21 生效日期 暂无
有效性状态 废止日期 暂无
备注 2014年6月21日,欧盟发布委员会实施条例(EU) No 681/2014,设定药理学活性物质碘醚柳胺(rafoxanide)在牛和羊的乳汁中的临时最大残留限量为10 μg/kg,此临时MRL至2015年12月31日到期。

  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 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 (hereinafter ‘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 is to 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 (2).

  (3)

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

  (4)

  A request for an opinion on the extrapolation of the existing entry for rafoxanide applicable to bovine milk has been submitted to the European Medicines Agency.

  (5)

  The Committee for Medicinal Products for Veterinary Use has recommended the establishment of a provisional MRL for rafoxanide for bovine and ovine milk and the removal of the prohibition to use that substance in animals from which milk is produced for human consumption.

  (6)

  The entry for rafoxanide in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the recommended provisional MRL for bovine and ovine milk and to remove the prohibition to use that substance from animals from which milk is produced for human consumption.

  (7)

  The provisional MRL for rafoxanide set out in that Table should expire on 31 December 2015.

  (8)

  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.

  (9)

  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 19 August 2014.

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

  Done at Brussels, 20 June 2014.

  For the Commission

  The President

  José Manuel BARROSO

ANNEX

In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance ‘rafoxanide’ 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

‘Rafoxanide

Rafoxanide

Bovine

30 μg/kg

Muscle

NO ENTRY

Antiparasitic agents/Agents against endoparasites’

30 μg/kg

Fat

10 μg/kg

Liver

40 μg/kg

Kidney

Ovine

100 μg/kg

Muscle

250 μg/kg

Fat

150 μg/kg

Liver

150 μg/kg

Kidney

Bovine, ovine

10 μg/kg

Milk

Provisional MRL shall expire on 31 December 2015


 

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