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(EU) No 1277/2014:就药理学活性物质拉沙里菌素(lasalocid),修订(EU) No 37/2010号法规(amending Regulation (EU) No 37/2010, as regards the substance ‘lasalocid’)

嘉峪检测网        2015-09-01 15:37

【发布单位】 EUROPEAN COMMISSION
【发布文号】 (EU) No 1277/2014
【发布日期】 2014-12-02
【生效日期】
【废止日期】
【替代法规】
【效  力】
【食品伙伴网解读】 (EU) No 37/2010附录表1规定,允许对家禽和牛使用药理学活性物质拉沙里菌素,其残留限量要求适用于家禽的肌肉、皮肤和脂肪、肝脏、肾脏和蛋以及牛的肌肉、脂肪、肝脏和肾脏(供人类食用奶类生产动物除外)。欧洲药品管理局收到了一份关于修订现行拉沙里菌素条目的申请。兽药产品委员会对申请者提供的拉沙里菌素的附加数据进行了评估,建议修订现行拉沙里菌素的每日允许摄入量及家禽中现行的拉沙里菌素最大残留限量。依据(EC) No 470/2009第5条相关规定,欧洲药品管理局认为可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。通过评估,兽药产品委员会认为:不支持将这种物质在家禽和牛中的残留限量扩大到其他食用动物中。综上,对(EU) No 37/2010附录表格1中“拉沙里菌素”条目进行相应的修订。

  COMMISSION IMPLEMENTING REGULATION (EU) No 1277/2014

  of 1 December 2014

  amending Regulation (EU) No 37/2010, as regards the substance ‘lasalocid’

  (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 (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 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)

  Lasalocid is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for poultry species, applicable to muscle, skin and fat, liver, kidney and eggs, and for bovine species, applicable to muscle, fat, liver and kidney, excluding animals producing milk for human consumption.

  (4)

  An application for the amendment of the existing entry for lasalocid has been submitted to the European Medicines Agency.

  (5)

  Additional data on lasalocid was provided and assessed by the Committee for Medicinal Products for Veterinary Use. As a result that Committee recommended the amendment of the current acceptable daily intake for lasalocid, as well as the amendment of the existing MRL for lasalocid in poultry.

  (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.

  (7)

  The Committee for Medicinal Products for Veterinary Use concluded that the extrapolation to other food producing species cannot be supported for this substance.

  (8)

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

  (9)

  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.

  (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 20 February 2015.

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

  Done at Brussels, 1 December 2014.

  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 ‘lasalocid’ 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
‘Lasalocid
Lasalocid A
Poultry
60 μg/kg
300 μg/kg
150 μg/kg
300 μg/kg
150 μg/kg
Muscle
Liver
Kidney
Skin and fat in natural proportions
Eggs
NO ENTRY
Anti-infectious agents/Antibiotics’
Bovine
10 μg/kg
20 μg/kg
100 μg/kg
20 μg/kg
Muscle
Fat
Liver
Kidney
Not for use in animals from which milk is produced for human consumption

 

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