(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)

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

(4)

An application for the extension of the existing entry for gamithromycin to porcine species 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. The Committee for Medicinal Products for Veterinary Use concluded that the extrapolation to other food producing species cannot be supported for this substance.

(6)

The entry for gamithromycin in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the MRL for porcine species.

(7)

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.

(8)

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