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欧盟委员会修订兽药加米霉素(gamithromycin)在反刍动物中的残留限量要求

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核心提示:欧盟委员会2016?1?4日发布通告,修订兽药加米霉素(gamithromycin)在猪、牛以及反刍动物中的残留限量要求,本法规适用于欧盟所有成员国,于2016?2?4日生效、/div>
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有效性状?/th> 废止日期 暂无
备注 欧盟委员?016?1?4日发布通告,修订兽药加米霉素(gamithromycin)在猪、牛以及反刍动物中的残留限量要求,本法规适用于欧盟所有成员国,于2016?2?4日生效。具体限量要求如下:

药物活性物?/span>

标志残留?/span>

动物种类

残留限量MRLs

靶组细/span>

其他规定(根据法规'/span>EU(/span>470/2009?/span>14章第7条规定)

功能用逓/span>

加米霉素'/span>Gamithromycin(/span>

加米霉素'/span>Gamithromycin(/span>

除牛以外的所有反刍动?/span>

50 g/kg

肌肉

该兽药不能用于产供人食用牛奶的奶牛中

抗感染药?/span>/抗生紟/span>Anti-infectious agents/Antibiotics

50 g/kg

脂肪

300 g/kg

肝脏

200 g/kg

肾脏

牚/span>

20 g/kg

脂肪

200 g/kg

肝脏

100 g/kg

肾脏

?/span>

100 g/kg

肌肉

NO ENTRY

100 g/kg

天然比例的皮和脂?/span>

100 g/kg

肝脏

300 g/kg

肾脏

COMMISSION IMPLEMENTING REGULATION (EU) 2016/2045

of 23 November 2016

amending Regulation (EU) No 37/2010 as regards the substance gamithromycin

(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 (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)

Gamithromycin is already included in that table as an allowed substance for bovine species, applicable to fat, liver and kidney, excluding animals producing milk for human consumption and for porcine species, applicable to muscle, skin and fat, liver and kidney.

(4)

An application for the extension of the existing entry for gamithromycin to ovine species has been submitted to the European Medicines Agency (EMA).

(5)

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.

(6)

The EMA has considered that the extrapolation of the extended entry for gamithromycin to all ruminants except bovine is appropriate.

(7)

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

(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.

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

Done at Brussels, 23 November 2016.

For the Commission

The President

Jean-Claude JUNCKER

地区9/font>欧盟
标签9/font>残留限量兽药
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