(fra kommisjonsforordningen)

(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 foodproducing animals or in biocidal products used in animal husbandry. 

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

(3) The substance ketoprofen is included in that Regulation as an allowed substance for bovine, porcine and Equidae species. The existing entry for bovine, porcine and Equidae species has a ‘no MRL required’ classification. 

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

(5) On 12 May 2022, the Agency, based on the opinion of the Committee for Veterinary Medicinal Products, recommended the establishment of a ‘no MRL required’ classification for the substance ketoprofen in poultry. 

(6) On 1 March 2023, the Commission requested the Agency to review its opinion of 12 May 2022 to further examine possible safety concerns with regard to some metabolites and, where appropriate, to recommend MRLs for ketoprofen in poultry tissues. Simultaneously, in accordance with Article 11 of Regulation (EC) No 470/2009, the Commission also requested the Agency to assess whether maintaining a ‘no MRL required’ classification of ketoprofen in bovine, porcine and Equidae species is appropriate. 

(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 MRLs for ketoprofen use in poultry, 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) By Commission Implementing Regulation (EU) 2023/2194, the substance ketoprofen was therefore included in Regulation (EU) No 37/2010 as an allowed substance for poultry. 

(9) On 7 November 2024, the Agency, based on the opinion of the Committee for Veterinary Medicinal Products, and having considered the request from the Commission, recommended the establishment of MRLs for ketoprofen use in bovine and porcine species, applicable to muscle, fat, liver, kidney and milk. 

(10) 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 to all ruminants and Equidae is also appropriate. 

(11) In view of the opinion of the Agency, the Commission considers it appropriate to establish the recommended MRLs for ketoprofen in bovine and porcine tissues and to extrapolate it to all ruminants and Equidae. 

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

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