ELI: http://data.europa.eu/eli/reg_impl/2023/2203/oj 1/3COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/2203 
of 20 Oct ober 2023
amending Regulation (EU) No 37/2010 as regards the classif ication of the subst ance rafo xanide 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) Rafoxanide is already included in that table as an allowed substance for bovine and ovine species, applicable to 
muscle, fat, liver and kidne y. The provisional MRL for that substance set out for bovine and ovine, applicable to 
milk, expired on 31 December 2017 .
(4) In accordance with Article 27(2) of Regulation (EC) No 470/2009, on 21 Febr uary 2023 , Ireland submitte d a request 
to the European Medicines Agen cy (‘Agen cy’) for the extrapolation of the existing entr y for rafoxanide to bovine and 
ovine milk.
(5) On 20 Apr il 2023 , through the opinion of the Committ ee for Veterinar y Medicinal Products, the Agen cy 
recommended the establishment of a definitive MRL for rafoxanide in bovine and ovine milk.
(6) 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.
(7) The Age ncy concluded that the extrapolation of the existing entr y for rafoxanide to all ruminants, excep t ovine, is 
appropr iate.
(8) In view of the opinion of the Agen cy, the Commission considers it appropr iate to establish an MRL for rafoxanide in 
bovin e and ovine, in relation to milk and to extrapolat e the MRL for rafoxanide to all ruminants excep t ovine.
(9) Regulation (EU) No 37/2010 should theref ore be amended according ly.
(10) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Veterinar y Medicinal Products,
(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    
2023/2203  23.10.2023ELI: http://data.europa.eu/eli/reg_impl/2023/2203/oj 2/3HAS 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, 20 Octobe r 2023 .
For the Commission
The President
Ursula VON DER LEYENOJ L, 23.10.2023 EN  ELI: http://data.europa.eu/eli/reg_impl/2023/2203/oj 3/3ANNEX 
In Table 1 of the Annex to Regulation (EU) No 37/2010, the entr y for the substance ‘rafoxanide’ is replaced by the followi ng:
Phar macologically active 
SubstanceMarker residue Animal Species MRL Target TissuesOther Provisions (according 
to Article 14(7) of 
Regulation (EC) 
No 470/2009)Therapeutic Classif ication
‘Rafo xanide Rafoxanide All ruminants excep t 
ovine30μg/kg
30μg/kg
10μg/kg
40μg/kg
10μg/kgMuscle
Fat
Liver
Kidney
MilkNO ENTR Y Antiparasitic 
agents/Agents (acting) 
against endoparasite s’
Ovine 100 μg/kg
250 μg/kg
150 μg/kg
150 μg/kg
10μg/kgMuscle
Fat
Liver
Kidney
MilkNO ENTR YOJ L, 23.10.2023 EN