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(EU) No 2015/1492:就泰乐菌素,修订法规(EU) No 37/2010附录(amending Regulation (EU) No 37/2010 as regards the substance ‘tylvalosin’)

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放大字体  缩小字体 2015-09-28 10:00:29  来源:EUROPE  浏览次数:2858
核心提示:(EU) No 37/2010附录表1规定,允许对猪和家禽使用药理学活性物质乙酰异戊酰泰乐菌素,其残留限量要求适用于猪的肌肉、皮肤和脂肪、肝脏、肾脏和家禽的皮肤和脂肪、肝脏,并建议将乙酰异戊酰泰乐菌素的最大残留限量应用到鸡蛋中。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:支持将这种物质的残留限量扩大到其他禽类蛋中。综上,对(EU) No 37/2010附录表格1中“乙酰异戊酰泰乐菌素”条目进行相应的修订。
发布单位
EUROPEAN COMMISSION
EUROPEAN COMMISSION
发布文号 (EU) No 2015/1492
发布日期 2015-09-03 生效日期 2015-11-03
有效性状态 废止日期 暂无
备注 2015年9月4日,欧盟发布委员会条例,就泰乐菌素,修订 (EU) No 37/2010号法规。(EU) No 37/2010附录表1规定,允许对猪和家禽使用药理学活性物质泰乐菌素,其残留限量适用于猪的肌肉、皮肤、脂肪、肝脏、肾脏和家禽的皮肤、脂肪和肝脏(供人类食用产蛋动物除外)。一份提交到EMA的申请建议扩大泰乐菌素的使用范围,即制定其在鸡蛋中的最大残留限量。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:支持将泰乐菌素使用范围扩大到其他禽类蛋中。综上,对(EU) No 37/2010附录表格1中“乙酰异戊酰泰乐菌素”条目进行相应的修订,其用于禽蛋中的最大残留限量为200 μg/kg。
  COMMISSION IMPLEMENTING REGULATION (EU) 2015/1492
 
  of 3 September 2015
 
  amending Regulation (EU) No 37/2010 as regards the substance ‘tylvalosin’
 
  (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)
 
  Article 17 of Regulation (EC) No 470/2009 requires that 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 established in a regulation.
 
  (2)
 
  Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin.
 
  (3)
 
  Tylvalosin is currently included in that table as an allowed substance, for porcine and poultry species, applicable to muscle, skin and fat, liver and kidney in porcine species and to skin and fat and liver in poultry species, excluding animals producing eggs for human consumption.
 
  (4)
 
  An application for the extension of the existing entry for tylvalosin to chicken eggs has been submitted to the European Medicines Agency (hereinafter ‘EMA’).
 
  (5)
 
  The EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use has recommended the establishment of a MRL for chicken eggs.
 
  (6)
 
  According to Article 5 of Regulation (EC) No 470/2009 the EMA 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 EMA has considered that the extrapolation of the MRLs for tylvalosin from chicken eggs to eggs of other poultry species is appropriate.
 
  (8)
 
  Regulation (EU) No 37/2010 should therefore be amended accordingly.
 
  (9)
 
  It is appropriate to grant the stakeholders concerned a reasonable period of time to take measures that may be required to comply with the new MRL.
 
  (10)
 
  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 3 November 2015.
 
  This Regulation shall be binding in its entirety and directly applicable in all Member States.
 
  Done at Brussels, 3 September 2015.
 
  For the Commission
 
  The President
 
  Jean-Claude JUNCKER
 
  (1)  OJ L 152, 16.6.2009, p. 11.
 
  (2)  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 (OJ L 15, 20.1.2010, p. 1).
 
  ANNEX
 
  In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance 'tylvalosin' 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

‘Tylvalosin

Tylvalosin

Porcine

50 μg/kg

50 μg/kg

50 μg/kg

50 μg/kg

Muscle

Skin and fat

Liver

Kidney

NO ENTRY

Anti-infectious agents/Antibiotics’

Poultry

200 μg/kg

Eggs

Sum of Tylvalosin and 3-0-acetyltylosin

Poultry

50 μg/kg

50 μg/kg

Skin and fat

Liver


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