(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 are 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)

Butafosfan is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance for bovine species, while establishing the absence of the need to establish an MRL.

(4)

An application for the extension of the existing entry for butafosfan applicable to porcine species has been submitted to the European Medicines Agency.

(5)

The Committee for Medicinal Products for Veterinary Use recommended that there is no need to establish an MRL for butafosfan for porcine species.

(6)

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 another species.

(7)

The CVMP recommended the extrapolation of the evaluation results of butafosfan from bovine and porcine species to all mammalian food-producing species.

(8)

The entry for butafosfan in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the substance butafosfan for all mammalian food-producing species, while establishing the absence of the need to establish an MRL.

(9)

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