当前位置: 首页? 政策法规? 国外法规? 欧盟扩大药物活性物质乙酰氨基阿维菌素适用范围

欧盟扩大药物活性物质乙酰氨基阿维菌素适用范围

扫描二维 分享好友和朋友圈
放大字体缩小字体2018-05-18 01:35:00 来源9a href="http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2018.122.01.0008.01.ENG&toc=OJ:L:2018:122:TOC" target="_blank" rel="nofollow">欧盟委员伙/a> 浏览次数9span id="hits">4017
核心提示?EU) No 37/2010?为药物活性物质清单,有提议建议欧洲药品管理局(EMA)扩大此清单中乙酰氨基阿维菌素的适用范围至鳍鱼中。EMA评估后认为乙酰氨基阿维菌素可用于鳍鱼和野兔中,并制定最大残留限量:鳍鱼50 μg/kg、野兔肉50 μg/kg、野兔脂?50 μg/kg、野兔肝1 500 μg/kg、野兔肾300 μg/kg。欧盟委员会针对上述意见修订(EU) No 37/2010中相应内容、/div>
发布单位
欧盟委员
欧盟委员伙/div>
发布文号 (EU) 2018/722
发布日期 2018-05-16 生效日期 2018-06-05
有效性状?/th> 废止日期 暂无
备注 (EU) No 37/2010?为药物活性物质清单,有提议建议欧洲药品管理局(EMA)扩大此清单中乙酰氨基阿维菌素的适用范围至鳍鱼中。EMA评估后认为乙酰氨基阿维菌素可用于鳍鱼和野兔中,并制定最大残留限量:鳍鱼50 g/kg、野兔肉50 g/kg、野兔脂?50 g/kg、野兔肝1 500 g/kg、野兔肾300 g/kg。欧盟委员会针对上述意见修订(EU) No 37/2010中相应内容、/td>
COMMISSION IMPLEMENTING REGULATION (EU) 2018/722

of 16 May 2018

amending Regulation (EU) No 37/2010 to classify the substance eprinomectin as regards its maximum residue limit

(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 (EMA) formulated by the Committee for Medicinal Products for Veterinary Use,

Whereas:

?(/span> 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.

?(/span> 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.

?(/span> Eprinomectin is already included in that table as an allowed substance for all ruminants, applicable to muscle, fat, liver, kidney and milk.

?(/span> An application for the extension of the existing entry for eprinomectin to fin fish has been submitted to EMA.

?(/span> EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use, has recommended the establishment of an MRL for eprinomectin in fin fish.

?(/span> According to Article 5 of Regulation (EC) No 470/2009, 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.

?(/span> EMA has considered that the extrapolation of the entry for eprinomectin to the tissues of horses and rabbits is appropriate.

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

?(/span> 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.

?0(/span> 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 16 July 2018.

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

Done at Brussels, 16 May 2018.

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 eprinomectin is replaced by the following:

Pharmacologically active Substance

Marker residue

Animal Species

MRLs

Target Tissues

Other Provisions (according to Article 14(7) of Regulation (EC) No 470/2009)

Therapeutic Classification

Eprinomectin

Eprinomectin B1a

All ruminants, equidae

50 g/kg

Muscle

NO ENTRY

Antiparasitic agents/Agents acting against endo- and ectoparasites

250 g/kg

Fat

1 500 g/kg

Liver

300 g/kg

Kidney

20 g/kg

Milk

Fin fish

50 g/kg

Muscle and skin in natural proportions

Rabbits

50 g/kg

Muscle

250 g/kg

Fat

1 500 g/kg

Liver

300 g/kg

Kidney

食品伙伴网提供标准法规解读、舆情监控、合规咨询、申报注册等服务、br/>电询?535-2129301
QQ?891238009
食品标法? border=
实时把握 食品标法动?/span>
请扫码关?span class="color2">食品标法圇/span>

声明9/p>

凡本网所有原?编译文章及图片、图表的版权均属食品伙伴网所有,如要转载,需注明“信息来源:食品伙伴网”、br> 凡本网注明“信息来源:XXX(非食品伙伴网)”的作品,均转载自其他媒体,转载目的在于传递更多的信息,并不代表本网赞同其观点和对其真实性负责、br> 邮箱:law#www.sqrdapp.com(发邮件时请?换成@ QQ?39307733

[ 政策法规搜索] [ 加入收藏] [ 告诉好友] [ 打印本文] [ 关闭窗口]


按分类浏觇/strong>
推荐国外法规
点击排行
    按国家或地区浏览

    法规中心 关于我们 广告业务 联系我们 信息服务

    Processed in 0.195 second(s), 10 queries, Memory 4.6 M
    Baidu
    map