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(EU) No 1359/2014:就药理学活性物质托拉菌素(tulathromycin),修订法规(EU) No 37/2010附录(amending the Annex to Regulation (EU) No 37/2010, as regards the substance tulathromycin)

嘉峪检测网        2015-09-01 15:37

【发布单位】 EUROPEAN COMMISSION
【发布文号】 (EU) No 1359/2014
【发布日期】 2014-12-19
【生效日期】
【废止日期】
【替代法规】
【效  力】
【食品伙伴网解读】 欧洲药品管理局收到一份关于修订现行托拉菌素条目的申请。兽药产品委员会(CVMP)建议修订现行的托拉菌素每日容许摄入量,且制定牛、猪中托拉菌素的临时最大残留限量(因为作为拟定最大残留量监测的分析方法还未经充分验证)。但是分析方法验证所需科学数据的不完备性对人类健康不构成危害。根据(EC) No 470/2009第5条相关规定,欧洲兽用医药产品委员会认为:不支持将这种物质的残留限量由牛、猪扩大到其他食用动物。综上,对(EU) No 37/2010进行相应的修正,修订内容包括牛、猪的肌肉、皮肤、脂肪、肝脏和肾脏中托拉菌素的临时最大残留限量。原表格中托拉菌素在牛、猪中的临时最大残留限量截止至2015年1月1日。

  COMMISSION IMPLEMENTING REGULATION (EU) No 1359/2014

  of 18 December 2014

  amending the Annex to Regulation (EU) No 37/2010, as regards the substance tulathromycin

  (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 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 are 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)

  Tulathromycin is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for bovine and porcine species, applicable to fat (skin and fat for porcine species), liver and kidney.

  (4)

  An application for the modification of the existing entry for tulathromycin has been submitted to the European Medicines Agency.

  (5)

  The CVMP recommended the modification of the current Acceptable Daily Intake for tulathromycin, as well as the establishment of a provisional MRL for bovine and porcine species as the analytical method for monitoring residues in bovine and porcine species is not sufficiently validated for the MRLs proposed. The incomplete scientific data on the validation of the analytical method does not constitute a hazard to human health.

  (6)

  In accordance with 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.

  (7)

  The Committee for Medicinal Products for Veterinary Use concluded that the extrapolation to other food producing species cannot be supported for this substance.

  (8)

  Regulation (EU) No 37/2010 should therefore be amended to include the provisional MRLs for tulathromycin in respect of bovine and porcine species, applicable to muscle, skin and fat, liver and kidney. The provisional MRLs set out in that Table for bovine and porcine species should expire on 1 January 2015.

  (9)

  Regulation (EU) No 37/2010 should therefore be amended accordingly.

  (10)

  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.

  (11)

  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 twentieth day following that of its publication in the Official Journal of the European Union.

  It shall apply from 17 February 2015.

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

  Done at Brussels, 18 December 2014 原文及附件下载:   (EU) No 1359_2014.pdf
 

  For the Commission

  The President

  Jean-Claude JUNCKER
 

  更多相关法规请见:欧盟关于兽药残留的(EU) No 37/2010号法规及其修订单汇总

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