欧盟扩大药物活性物质乙酰氨基阿维菌素适用范围

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