(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 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)

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

(4)

An application for the extension of the existing entry for methylprednisolone to equidae has been submitted to the European Medicines Agency.

(5)

In accordance with 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.

(6)

The Committee for Medicinal Products for Veterinary Use recommended the establishment of a MRL for methylprednisolone for equidae, and the extrapolation of the MRL for methylprednisolone from bovine milk to horse milk.

(7)

The entry for methylprednisolone in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the MRL for equidae, applicable to muscle, fat, liver, kidney and milk.

(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,