(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 is to 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 (2).

(3)

Rafoxanide is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for bovine and ovine species, applicable to muscle, fat, liver and kidney, excluding animals producing milk for human consumption.

(4)

A request for an opinion on the extrapolation of the existing entry for rafoxanide applicable to bovine milk has been submitted to the European Medicines Agency.

(5)

The Committee for Medicinal Products for Veterinary Use has recommended the establishment of a provisional MRL for rafoxanide for bovine and ovine milk and the removal of the prohibition to use that substance in animals from which milk is produced for human consumption.

(6)

The entry for rafoxanide in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the recommended provisional MRL for bovine and ovine milk and to remove the prohibition to use that substance from animals from which milk is produced for human consumption.

(7)

The provisional MRL for rafoxanide set out in that Table should expire on 31 December 2015.

(8)

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.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,