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(EU) 2015/149:就药理学活性物质甲基强的松龙(methylprednisolone),修订(EU) No 37/2010号法规附录(amending the Annex to Regulation (EU) No 37/2010 as regards the substance ‘methylprednisolone’)

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放大字体  缩小字体 2015-02-10 11:30:17  来源:EUROPE  浏览次数:2413
核心提示:欧盟发布委员会实施条例(EU) 2015/149,对(EU) No 37/2010附录进行修正。其附录中增加马科动物中甲基强的松龙的最大残留限量,其在马的肌肉、脂肪、肝脏、肾脏和乳汁的最大残留限量分别为10ug/kg、10ug/kg、10ug/kg、10ug/kg和2 μg/kg。
发布单位
EUROPEAN COMMISSION
EUROPEAN COMMISSION
发布文号 (EU) 2015/149
发布日期 2015-01-31 生效日期 暂无
有效性状态 废止日期 暂无
备注 (EU) No 37/2010附录表1规定,允许对牛使用药理学活性物质甲基强的松龙,其残留限量要求适用于牛的肌肉、脂肪、肝脏、肾脏和乳汁。欧洲药品管理局收到了一份关于将甲基强的松龙的使用范围扩大至马科动物的申请。根据(EC) No 470/2009第5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。兽药产品委员会建议针对马科动物制定甲基强的松龙的最大残留限量,并且将甲基强的松龙在牛乳中的最大残留限量应用到马乳中。因此,应对(EU) No 37/2010附录表1中条目“甲基强的松龙”进行相应修正,增加马科动物中甲基强的松龙的最大残留限量,其在马的肌肉、脂肪、肝脏、肾脏和乳汁的最大残留限量分别为10ug/kg、10ug/kg、10ug/kg、10ug/kg和2 μg/kg。

  COMMISSION IMPLEMENTING REGULATION (EU) 2015/149

  of 30 January 2015

  amending the Annex to Regulation (EU) No 37/2010 as regards the substance ‘methylprednisolone’

  (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)

  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)

  Methylprednisolone is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for bovine species, applicable to muscle, fat, liver, kidney and milk.

  (4)

  An application for the extension of the existing entry for methylprednisolone to equidae has been submitted to the European Medicines Agency.

  (5)

  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.

  (6)

  The Committee for Medicinal Products for Veterinary Use recommended the establishment of a MRL for methylprednisolone for equidae, and the extrapolation of the MRL for methylprednisolone from bovine milk to horse milk.

  (7)

  The entry for methylprednisolone in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the MRL for equidae, applicable to muscle, fat, liver, kidney and milk.

  (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 the newly set MRL.

  (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 1 April 2015.

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

  Done at Brussels, 30 January 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 ‘methylprednisolone’ 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
‘Methylprednisolone
Methylprednisolone
Equidae
10 μg/kg
10 μg/kg
10 μg/kg
10 μg/kg
2 μg/kg
Muscle
Fat
Liver
Kidney
Milk
NO ENTRY
Corticoides/Glucocorticoides’
Bovine
10 μg/kg
10 μg/kg
10 μg/kg
10 μg/kg
2 μg/kg
Muscle
Fat
Liver
Kidney
Milk
NO ENTRY


 

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