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(EU) 2015/2062:就维吉霉素,修订法?EU) No 37/2010(amending Regulation (EU) No 37/2010 as regards the substance ‘sisapronil’)

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放大字体缩小字体2015-11-30 01:38:04 来源9a href="http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2015.301.01.0007.01.ENG" target="_blank" rel="nofollow">欧盟浏览次数9span id="hits">3346
核心提示:关于制定牛物种中sisapronil最大残留限量的申请已提交至欧洲药品评价局。兽用药品委员会建议针对牛肌肉、脂肪、肝脏和肾脏制定sisapronil最大残留限量,但此规定不适用于产奶牛。并建议将sisapronil在牛肉中的最大残留限量应用到羊肉中。因此,(EU) No 37/2010附件表格中增加家禽类中维吉霉素的最大残留限量,在家禽类肌肉、脂肪、肝脏、肾脏中的限量值分别为10 0μg/kg?000 μg/kg?00 μg/kg?00 μg/kg、/div>
发布单位
欧盟委员
欧盟委员伙/div>
发布文号 (EU) 2015/2062
发布日期 2015-11-17 生效日期 2015-12-07
有效性状?/th> 废止日期 暂无
备注 2015?1?8日,欧盟发布委员会条?EU) 2015/2062,就维吉霉素,修订法?EU) No 37/2010。药理活性物质及其分类表格中不包含维吉霉素,欧洲药品管理局(EMA)建议对牛肌肉、脂肪、肝脏和肾脏制定维吉霉素的最大残留限量(产奶牛除外),并建议将维吉霉素在牛肉中的最大残留限量应用到羊肉中。因此,(EU) No 37/2010附件表格中增加维吉霉素在牛羊中(产奶牛除外)的最大残留限量,在肌肉、脂肪、肝脏、肾脏中的限量值分别为10 0g/kg?000 g/kg?00 g/kg?00 g/kg、/td>
  COMMISSION IMPLEMENTING REGULATION (EU) 2015/2062
  of 17 November 2015
  amending Regulation (EU) No 37/2010 as regards the substance sisapronil
  (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)
  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)
  Sisapronil is not yet included in that table.
  (4)
  An application for the establishment of MRLs for sisapronil in bovine species 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 an MRL for sisapronil in bovine species, applicable to muscle, fat, liver and kidney, provided that the substance is not used for animals from which milk is produced for human consumption.
  (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 MRL for sisapronil from bovine to caprine 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 17 January 2016.
  This Regulation shall be binding in its entirety and directly applicable in all Member States.
  Done at Brussels, 17 November 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, an entry for the following substance is inserted in alphabetical order:

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

Sisapronil

Sisapronil

Bovine, caprine

100 g/kg

2 000 g/kg

200 g/kg

100 g/kg

Muscle

Fat

Liver

Kidney

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

Antiparasitic agents/Agents against ectoparasites

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