Commission Implementing Regulation (EU) 2016/2045Show full title

Commission Implementing Regulation (EU) 2016/2045

of 23 November 2016

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

(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) 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.

(2) 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.

(3) Gamithromycin is already included in that table as an allowed substance for bovine species, applicable to fat, liver and kidney, excluding animals producing milk for human consumption and for porcine species, applicable to muscle, skin and fat, liver and kidney.

(4) An application for the extension of the existing entry for gamithromycin to ovine species has been submitted to the European Medicines Agency (EMA).

(5) According to Article 5 of Regulation (EC) No 470/2009, the 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.

(6) The EMA has considered that the extrapolation of the extended entry for gamithromycin to all ruminants except bovine is appropriate.

(7) Regulation (EU) No 37/2010 should therefore be amended accordingly.

(8) 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.

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

Done at Brussels, 23 November 2016.

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 ‘gamithromycin’ 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
‘Gamithromycin	Gamithromycin	All ruminants except bovine	50 μg/kg	Muscle	Not for use in animals producing milk for human consumption	Anti-infectious agents/Antibiotics’
			50 μg/kg	Fat
			300 μg/kg	Liver
			200 μg/kg	Kidney
		Bovine	20 μg/kg	Fat
			200 μg/kg	Liver
			100 μg/kg	Kidney
		Porcine	100 μg/kg	Muscle	NO ENTRY
			100 μg/kg	Skin and fat in natural proportions
			100 μg/kg	Liver
			300 μg/kg	Kidney

(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).