Commission Implementing Regulation (EU) 2025/1105 of 3 June 2025 amending Regulation (EU) No 37/2010 as regards the classification of the substance ketoprofen with respect to its maximum residue limit in foodstuffs of animal origin
Date: 2025-06-03
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal product, consumer protection, drug residue, food safety, foodstuff, health legislation, human nutrition, livestock, veterinary medicinal product








L_202501105EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/1105


4.6.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/1105
of 3 June 2025
         
amending Regulation (EU) No 37/2010 as regards the classification of the substance ketoprofen with respect to its maximum residue limit in foodstuffs of animal origin
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (1), and in particular Article 14, in conjunction with Article 17, thereof,

Whereas:







(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)


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 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 (3), 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,





HAS ADOPTED THIS REGULATION:



Article 1
The Annex to Regulation (EU) No 37/2010 is amended as set out in the Annex to this Regulation.


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 3 June 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 152, 16.6.2009, p. 11, ELI: http://data.europa.eu/eli/reg/2009/470/oj.

(2)  Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1, ELI: http://data.europa.eu/eli/reg/2010/37(1)/oj).

(3)  Commission Implementing Regulation (EU) 2023/2194 of 19 October 2023 amending Regulation (EU) No 37/2010 as regards the classification of the substance ketoprofen with respect to its maximum residue limit in foodstuffs of animal origin (OJ L, 2023/2194, 20.10.2023, ELI: http://data.europa.eu/eli/reg_impl/2023/2194/oj).




ANNEX
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entry for the substance ‘ketoprofen’ is replaced by the following:












Pharmacologically active Substance


Marker residue


Animal Species


MRL


Target Tissues


Other Provisions

(according to Article 14(7) of Regulation (EC) No 470/2009)



Therapeutic Classification




‘Ketoprofen


Ketoprofen


All ruminants,
porcine,

Equidae



50  μg/kg
20  μg/kg
20  μg/kg
50  μg/kg
20  μg/kg


Muscle
Fat
Liver
Kidney
Milk


For porcine species the fat MRL relates to ‘skin and fat in natural proportions’


NO ENTRY




Ketoprofen


Poultry


10  μg/kg
30  μg/kg
10  μg/kg
10  μg/kg


Muscle
Skin and fat in natural proportion
Liver
Kidney


Not for use in animals from which eggs are produced for human consumption


NO ENTRY’








ELI: http://data.europa.eu/eli/reg_impl/2025/1105/oj
ISSN 1977-0677 (electronic edition)