(1)

In accordance with Regulation (EC) No 470/2009, the Commission is to establish, by way of a regulation, maximum residue limits (‘MRLs’) 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.

(2)

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

(3)

The substance ketoprofen is already included in that table as an allowed substance for bovine, porcine and equidae species. The existing entry has a ‘no MRL required’ classification.

(4)

In accordance with Article 3 of Regulation (EC) No 470/2009, on 14 December 2020, Huvepharma nv submitted an application to the European Medicines Agency (‘Agency’) for the extension of the existing entry for the substance ketoprofen to chicken.

(5)

On 12 May 2022, the Agency, through the opinion of the Committee for Veterinary Medicinal Products, recommended the establishment of a ‘no MRL required’ classification for the substance ketoprofen in chicken.

(6)

On 1 March 2023, the Commission requested the Agency to reconsider its opinion of 12 May 2022 to further examine possible safety concerns with regard to some metabolites and, where appropriate, to recommend numerical MRLs for ketoprofen in chicken tissues.

(7)

On 16 May 2023, the Agency, based on the opinion of the Committee for Veterinary Medicinal Products, and having considered the application of Huvepharma nv and the request from the Commission, recommended the establishment of numerical MRLs for ketoprofen use in chicken, applicable to muscle, skin and fat in natural proportion, liver and kidney, but not for use in animals from which eggs are produced for human consumption.

(8)

In accordance with Article 5 of Regulation (EC) No 470/2009, the 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 Agency concluded that the extrapolation of the MRLs for ketoprofen from chicken tissues to the tissues of other poultry species is appropriate, but not to poultry eggs as no residue depletion data for the substance ketoprofen in eggs were provided.

(9)

In view of the opinion of the Agency, the Commission considers it appropriate to establish the recommended MRL for ketoprofen in chicken tissues and to extrapolate it to other poultry species, but not to poultry eggs.

(10)

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

(11)

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