ELI: http://data.europa.eu/eli/reg_impl/2023/2194/oj 1/3COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/2194 
of 19 Oct ober 2023
amending Regulation (EU) No 37/2010 as regards the classif ication of the subst ance ketoprofen with 
respect to its maximum residue limit in foodst uffs of animal origin 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng regar d 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 phar macologically 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 phar macologically active substances intended for use in the Union in vete rinar y medicinal 
products for food-producing animals or in biocidal products used in animal husbandr y.
(2) Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2)sets out the phar macologically active 
substances and their classification regar ding MRLs in foodstuffs of animal origin.
(3) The substance ketoprof en is already included in that table as an allowed substance for bovine , porcine and equidae 
species. The existing entr y has a ‘no MRL required’ classif ication.
(4) In accordance with Article 3 of Regulation (EC) No 470/2009, on 14 December 2020 , Huvephar ma nv submitted an 
application to the European Medicines Age ncy (‘Agen cy’) for the exte nsion of the existing entr y for the substance 
ketoprof en to chick en.
(5) On 12 May 2022 , the Agen cy, through the opinion of the Committee for Veterinar y Medicinal Products, 
recommended the establishment of a ‘no MRL required’ classification for the substance ketoprofen in chick en.
(6) On 1 March 2023 , the Commission request ed the Agen cy to reconsider its opinion of 12 May 2022 to further 
examine possible safety concer ns with regar d to some metabolites and, where appropr iate, to recommend 
numer ical MRLs for ketoprof en in chick en tissues.
(7) On 16 May 2023 , the Agen cy, based on the opinion of the Committ ee for Veterinar y Medicinal Products, and having 
considered the application of Huvephar ma nv and the request from the Commission, recommended the 
establishment of numer ical MRLs for ketoprof en use in chick en, applicable to muscle, skin and fat in natural 
propor tion, liver and kidney , but not for use in animals from which eggs are produced for human consum ption.
(8) In accordance with Article 5 of Regulation (EC) No 470/2009, the Age ncy is to consider using MRLs established for 
a phar macologically active substance in a particular foodstuff for another foodstuff derived from the same species, or 
MRLs established for a phar macologically active substance in one or more species for other species. The Agen cy 
(1)OJ L 152, 16.6.2009, p. 11.
(2)Commission Regulation (EU) No 37/2010 of 22 December 2009 on phar macologically active substances and their classif ication 
regar ding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).
Offi cial Jour nal  
of the European Union EN 
L series    
2023/2194  20.10.2023ELI: http://data.europa.eu/eli/reg_impl/2023/2194/oj 2/3concluded that the extrapolation of the MRLs for ketoprofen from chic ken tissues to the tissues of other poultr y 
species is appropr iate, but not to poultr y eggs as no residue depletion data for the substance ketoprof en in eggs 
were provi ded.
(9) In view of the opinion of the Agency , the Commission considers it appropr iate to establish the recommended MRL 
for ketoprof en in chicken tissues and to extrapolat e it to other poultr y species, but not to poultr y eggs.
(10) Regulation (EU) No 37/2010 should theref ore be amended according ly.
(11) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Veterinar y Medicinal Products,
HAS ADOPTED THIS REGUL ATION:
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 followi ng 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, 19 Octobe r 2023 .
For the Commission
The President
Ursula VON DER LEYENOJ L, 20.10.2023 EN  ELI: http://data.europa.eu/eli/reg_impl/2023/2194/oj 3/3ANNEX 
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entr y for the substance ‘ketopr ofen’ is replaced by the following:
Phar macologically 
active SubstanceMarker residue Animal Species MRL Target TissuesOther Provisions (according 
to Article 14(7) of 
Regulation (EC) 
No 470/2009)Therapeutic 
Classific ation
‘Ketopro fen NOT APPLICABLE Bovin e,
Porcine,
EquidaeNo MRL required NOT APPLICABLE NO ENTR Y NO ENTR Y
Ketoprof en Poultr y 10μg/kg
30μg/kg
10μg/kg
10μg/kgMuscle
Skin and fat in natural propor tion
Liver
KidneyNot for use in animals 
from whic h eggs are 
produced for human 
consump tionNO ENTR Y’OJ L, 20.10.2023 EN  