Address https://gelex.eu/eli/EU/regulation/2012/86@2012-02-01/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2
3. ANNEX
4. ANNEX

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 Council, 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 (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 maximum residue limits 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.

(3) Lasalocid is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance for poultry species, applicable to muscle, skin and fat, liver, kidney and eggs.

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

(5) The Committee for Medicinal Products for Veterinary Use has recommended the extension of that entry to cover bovine species, applicable to muscle, fat, liver and kidney, excluding animals producing milk for human consumption.

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

(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 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 its publication in the Official Journal of the European Union. It shall apply from 2 April 2012.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 1 February 2012. For the Commission The President José Manuel Barroso

ANNEX

ANNEX

The entry for lasalocid 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 Lasalocid Lasalocid A Poultry 20 μg/kg Muscle NO ENTRY Anti-infectious agents/Antibiotics 100 μg/kg Skin and fat 100 μg/kg Liver 50 μg/kg Kidney 150 μg/kg Eggs Bovine 10 μg/kg Muscle Not for use in animals from which milk is produced for human consumption 20 μg/kg Fat 100 μg/kg Liver 20 μg/kg Kidney

Versions

1. 2012-02-01

Cited by

• Commission Regulation (EU) No 610/2012 of 9 July 2012 amending Regulation (EC) No 124/2009 of 10 February 2009 setting maximum levels for the presence of coccidiostats or histomonostats in food resulting from the unavoidable carry-over of these substances in non-target feed (Text with EEA relevance) Regulation · Grade B

  Maximum residue limits have been established for lasalocid sodium in food of animal origin from bovine species in the framework of Regulation (EC) No 470/2009 by Commission Implementing Regulation (EU) No 86/2012 of 1 February 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 lasalocid. Therefore, it is necessary to amend the provisions as regards lasalocid sodium.

• Council Decision of 9 July 2013 on the position to be adopted, on behalf of the European Union, in the Joint Committee established by the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco (2013/455/EU) Decision · Grade B

  Commission Implementing Regulation (EU) No 86/2012 of 1 February 2012 (OJ L 30, 2.2.2012, p. 6);