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, 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 37/2010 sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin.
(3)
Aluminium salicylate, basic is currently included in that table as an allowed substance for topical use in all food producing species, except bovine, caprine, equidae, rabbit and fin fish. Aluminium salicylate, basic is also allowed substance for bovine, caprine, equidae and rabbit species according to provisional MRL set for that substance which expire on 31 December 2016.
(4)
An application for the modification of the existing entry for aluminium salicylate, basic to remove the provisional status of the MRL in bovine, caprine, equidae and rabbit species has been submitted to the European Medicines Agency (hereinafter ‘EMA’).
(5)
The EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use, has recommended the removal of the provisional status of the MRL for aluminium salicylate, basic in bovine, caprine, equidae and rabbit species.
(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: