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(EU) No 1390/2014:就药理学活性物质依立诺克丁(eprinomectin),修订(EU) No 37/2010号法规附录(amending the Annex to Regulation (EU) No 37/2010, as regards the substance ‘eprinomectin’)

嘉峪检测网        2015-09-05 15:14

【发布单位】 EUROPEAN COMMISSION
【发布文号】 (EU) No 1390/2014
【发布日期】 2014-12-24
【生效日期】
【废止日期】
【替代法规】
【效  力】
【食品伙伴网解读】 (EU) No 37/2010号法规附录表1规定,允许对牛、绵羊和山羊使用药理学活性物质依立诺克丁(Eprinomectin),最大残留限量要求适用于肌肉、脂肪、肝脏、肾脏和乳汁。该物质在绵羊和山羊的肌肉、脂肪、肝脏、肾脏和乳汁中的临时最大残留限量已于2014年7月1日失效。兽医药品委员会建议延长依立诺克丁的临时最大残留限量期限,因为残留量监测的分析方法还未经充分验证。分析方法验证所需科学数据的不完备性不会对人类健康构成危害。根据(EC) No 470/2009第5条相关规定,欧洲药品管理局认为可将一种特定食品中某种药理学活性物质的最大残留限量应用于其他同类食品中;或是将一类或多类食品中某种药理学活性物质的最大残留限量应用于其他种类食品中。综上,应对(EU) No 37/2010附录表格1中的“依立诺克丁”条目进行相应的修订,将依立诺克丁临时最大残留限量的有效期延长至2016年6月30日。

  COMMISSION IMPLEMENTING REGULATION (EU) No 1390/2014

  of 19 December 2014

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

  (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 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)

  Eprinomectin is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for bovine, ovine and caprine species, applicable to muscle, fat, liver, kidney and milk. The provisional maximum residue limits for that substance set out for ovine and caprine species, applicable to muscle, fat, liver, kidney and milk expired on 1 July 2014.

  (4)

  The Committee for Medicinal Products for Veterinary Use (CVMP) recommended an extension of the provisional MRL as the analytical method for monitoring residues in ovine and caprine species is not sufficiently validated. The incomplete scientific data on the validation of the analytical method is not considered to constitute a hazard to human health.

  (5)

  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. The CVMP concluded that the extrapolation to other food producing species cannot be supported for this substance.

  (6)

  The entry for eprinomectin in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to extend the provisional MRL to 30 June 2016.

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

  It shall apply from 22 February 2015.

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

  Done at Brussels, 19 December 2014.

  For the Commission

  The President

  Jean-Claude JUNCKER
 

ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance ‘eprinomectin’ 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
‘Eprinomectin
Eprinomectin B1a
Bovine
50 μg/kg
250 μg/kg
1 500 μg/kg
300 μg/kg
20 μg/kg
Muscle
Fat
Liver
Kidney
Milk
NO ENTRY
Antiparasitic agents/Agents acting against endo- and ectoparasites’
Ovine, caprine
50 μg/kg
250 μg/kg
1 500 μg/kg
300 μg/kg
20 μg/kg
Muscle
Fat
Liver
Kidney
Milk
Provisional maximum residue limits expire on 30 June 2016


 

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