Commission Implementing Regulation (EU) No 436/2012

of 23 May 2012

amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance azamethiphos

(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 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)

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 should 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 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin2.
(3)

Azamethiphos is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for salmonidae species.

(4)

An application for the extension of the existing entry for azamethiphos applicable to fin fish species has been submitted to the European Medicines Agency.

(5)

The Committee for Medicinal Products for Veterinary Use recommended the extension of that entry and the absence of the need to establish an MRL for azamethiphos in fin fish species.

(6)

The entry for azamethiphos in Table 1 of the Annex to 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 third 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 May 2012.

For the Commission

The President

José Manuel Barroso

ANNEX

The entry corresponding to azamethiphos in Table 1 of the Annex to Regulation (EU) No 37/2010 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

‘Azamethiphos

NOT APPLICABLE

Fin fish

No MRL required

NOT APPLICABLE

NO ENTRY

Antiparasitic agents/Agents against ectoparasites’