(1)

Article 17 of Regulation (EC) No 470/2009 requires that 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 established in a Regulation.

(2)

Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding maximum residue limits (MRLs) in foodstuffs of animal origin.

(3)

Monepantel is currently included in that table as an allowed substance, for ovine and caprine species, applicable to muscle, fat, liver, kidney and milk.

(4)

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

(5)

The EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use, has recommended the establishment of an MRL for monepantel in bovine tissues, excluding animals producing milk for human consumption.

(6)

According to Article 5 of Regulation (EC) No 470/2009, the EMA 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.

(7)

The EMA has considered that the extrapolation of the MRL for monepantel from ovine and caprine milk to bovine milk is not appropriate at this time due to insufficient data.

(8)

Regulation (EU) No 37/2010 should therefore be amended accordingly.

(9)

It is appropriate to grant the stakeholders concerned a reasonable period of time to take measures that may be required to comply with the new MRL.

(10)

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