Commission Implementing Regulation (EU) 2016/305

of 3 March 2016

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

(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 Council1, 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 (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 established in a Regulation.

(2)
Table 1 of the Annex to Commission Regulation (EU) No 37/20102 sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin.
(3)

Gentamicin is already included in that table as an allowed substance, for bovine and porcine species, applicable to muscle, fat, liver and kidney, and in bovine milk.

(4)

In accordance with Article 27(2) of Regulation (EC) No 470/2009, the Commission submitted to the European Medicines Agency (hereinafter ‘EMA’) a request for extrapolation of the existing MRLs for gentamicin to other species or tissues.

(5)

The EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use, has recommended the extrapolation of the MRLs for gentamicin to all mammalian food producing species and fin fish.

(6)

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

(7)

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, 3 March 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 ‘gentamicin’ 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

‘Gentamicin

Sum of gentamicin C1, gentamicin C1a, gentamicin C2 and gentamicin C2a

All mammalian food producing species and fin fish

50 μg/kg

50 μg/kg

200 μg/kg

750 μg/kg

100 μg/kg

Muscle

Fat

Liver

Kidney

Milk

For fin fish the muscle MRL relates to “muscle and skin in natural proportions”

For porcine species the fat relates to “skin and fat in natural proportions”

Anti-infectious agents/Antibiotics’