# Commission Implementing Regulation (EU) No 115/2013Show full title

Commission Implementing Regulation (EU) No 115/2013 of 8 February 2013 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 diclazuril (Text with EEA relevance)         

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U.K.

# Commission Implementing Regulation (EU) No 115/2013                     

# of 8 February 2013

# 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 diclazuril                     

# (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 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 origin(2).

(3)Diclazuril is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for all ruminants                              and porcine species, for oral use only.

(4)An application for the extension of the existing entry for diclazuril applicable to poultry has been submitted to the European                              Medicines Agency.

(5)According to 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. The Committee for Medicinal                              Products for Veterinary Use recommended the establishment of a MRL for diclazuril for chicken and pheasant, applicable to                              muscle, skin and fat, liver and kidney, excluding animals from which eggs are produced for human consumption, and the extrapolation                              of MRLs for diclazuril from chicken and pheasant to poultry, applicable to muscle, skin and fat, liver and kidney, excluding                              animals from which eggs are produced for human consumption.

(6)The entry for diclazuril in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the                              MRL for poultry.

(7)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.

(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 1U.K.

The Annex to Regulation (EU) No 37/2010 is amended as set out in the Annex to this Regulation.

# Article 2U.K.

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 10 April 2013.

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

Done at Brussels, 8 February 2013.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

## ANNEXU.K.

The entry corresponding to diclazuril in Table 1 of the Annex to Regulation (EU) No 37/2010 is replaced by the following:

1

OJ L 152, 16.6.2009, p. 11.                           

2

OJ L 15, 20.1.2010, p. 1.