(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)

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

(4)

On 15 December 2010 the Commission requested that the European Medicines Agency issue a new opinion on the substance ivermectin to include the possibility of establishing a MRL for tissue muscle.

(5)

On 9 June 2011 the Committee for Medicinal Products for Veterinary Use (‘CVMP’) adopted an opinion recommending the establishment of MRLs for ivermectin in tissues, including muscle, for all mammalian food producing species.

(6)

On 25 October 2011 the Commission requested that the CVMP reconsider its opinion of 9 June 2011 and amend the part referring to residue levels at the injection site in the ‘Other provisions’ of Table 1 of the Annex to Regulation (EU) No 37/2010.

(7)

On 12 September 2013, the CVMP adopted a revised opinion recommending the establishment of a MRL for ivermectin for all mammalian food producing species, applicable to muscle, fat, liver and kidney, excluding animals from which milk is produced for human consumption. The CVMP recommended in its revised opinion that, for the purpose of monitoring the residues of ivermectin that, where the entire carcass is available, fat, liver or kidney should be sampled in preference to muscle as residues in these tissues deplete more slowly than residues in muscle.

(8)

The entry for ivermectin in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include MRLs for the pharmaceutical substance for all mammalian food producing species, applicable to muscle, fat, liver and kidney, excluding animals producing milk for human consumption.

(9)

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.

(10)

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