当前位置: 首页? 政策法规? 国外法规? (EU) 2015/446:就药理学活性物质硒酸钡,修?EU) No 37/2010号法?amending Regulation (EU) No 37/2010 as regards the substance ‘barium selenate?

(EU) 2015/446:就药理学活性物质硒酸钡,修?EU) No 37/2010号法?amending Regulation (EU) No 37/2010 as regards the substance ‘barium selenate?

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放大字体缩小字体2015-03-18 10:22:58 来源9a href="http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2015.074.01.0018.01.ENG" target="_blank" rel="nofollow">EUROPE浏览次数9span id="hits">2426
核心提示?015??8日,欧盟发布委员会实施条?EU) 2015/446,对(EU) No 37/2010进行相应的修正、/div>
发布单位
EUROPEAN COMMISSION
EUROPEAN COMMISSION
发布文号 (EU) 2015/446
发布日期 2015-03-18 生效日期 暂无
有效性状?/th> 废止日期 暂无
备注 (EU) No 37/2010附录?规定,允许对牛、羊使用硒酸钡,且无最大残留限量要求。根?EC) No 470/2009?1条相关规定,欧洲药品管理局收到一份关于重新评估硒酸钡意见的申请。欧洲兽用医药委员会肯定了其最初建议,即无需制定硒酸钡在牛、羊中的最大残留限量,但同时提出,由于牛和羊注射部位的硒酸钡和残留物硒的消耗是极其缓慢的,因此食用牛、羊的注射部位将导致消费者摄入的硒多于规定的安全用量。因此,为确保消费者对硒的暴露量在已制定的可耐受最高摄入量之下,欧洲兽用医药委员会建议兽药产品所用的硒酸钡不能以注射形式进行给药。另外,依据(EC) No 470/2009?条相关规定,欧洲药品管理局可考虑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。欧洲兽用医药产品委员会建议将硒酸钡在牛和羊中无最大残留限量要求的规定扩大到所有食用动物。因此,?EU) No 37/2010进行相应的修正、/td>

  COMMISSION IMPLEMENTING REGULATION (EU) 2015/446

  of 17 March 2015

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

  (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)

  Barium selenate is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance for bovine and ovine species with no MRL required status.

  (4)

  In accordance with Article 11 of Regulation (EC) No 470/2009, an application for a review of the opinion on barium selenate has been submitted to the European Medicines Agency.

  (5)

  The Committee for Medicinal Products for Veterinary Use (CVMP) confirmed its initial recommendation that there is no need to establish an MRL for barium selenate for bovine and ovine species. However, the CVMP concluded that because of the fact that the depletion of the substance and its residue selenium from an injection site is extremely slow, there is a risk that consumption of an injection site would lead to an intake of selenium greater than the established safe level. Therefore, to ensure that consumers' exposure to selenium is not above the established tolerable upper intake level, the CVMP recommended that barium selenate used in veterinary medicinal products should not be administered by injection.

  (6)

  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 recommended the extrapolation of the existing no MRL required status for barium selenate in relation to bovine and ovine species to all food producing species.

  (7)

  The entry for barium selenate in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended accordingly.

  (8)

  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 this Regulation.

  (9)

  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 May 2015.

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

  Done at Brussels, 17 March 2015.

  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 barium selenate 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
Barium selenate
NOT APPLICABLE
All food producing species
No MRL required
NOT APPLICABLE
Not for administration by injection
Alimentary tract and metabolism/mineral supplements


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