EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2020/6400  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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)    
EN 2  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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  470/2 009 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 an d 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 Council1, 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 -
producin g animals or in biocidal products used in animal husbandry.  
(2) Table 1 of the Annex to Commission Regulation (EU) No 37/20102 sets out the 
pharmacologically active substances and their classification regarding MRLs in 
foodstuffs of animal origin.  
(3) The substan ce 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 t he Committee for Veterinary 
Medicinal Products , recommended the establish ment 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 examin e possible safety concerns with regard to some 
metabolites  and, where  appropriate, to recommend numerical MRLs for ketoprofen in 
chicken tissues . 
                                                 
1 OJ L  152, 16.6.2009, p.  11. 
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).   
EN 3  EN (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 tiss ues 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 o pinion of the Agency , the Commission  consider s 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 opi nion 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 t wentieth  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,  
 For the Commission  
 Ursula von der LEYEN  
 The President