EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/1132 CIS 
(POOL/D4/2023/1132/1132 -EN 
CIS.docx)  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) No 37/2010 as regards the classification of the substance 
rafoxanide with respect to its maximum residue limit in foodstuffs of animal origin  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) No 37/2010 as regards the classification of the substance 
rafoxanide 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 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) Rafoxanide  is already included in that table  as an allowed substance for bovine  and 
ovine species , applicable to muscle, fat, liver  and kidney . 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 February 
2023, Ireland  submitted  a request  to the European Medicines Agency (' Agency ') for 
the extrapolation  of the existing entry  for rafoxanide  to bovine  and ovine  milk. 
(5) On 20 April 2023 , through the opinion of t he Committee for Veterinary Medicinal 
Products , the Agency recommended  the establish ment of a definitive MRL for 
rafoxanide  in bovine and  ovine milk. 
(6) 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 
                                                 
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 2  EN established for a pharmacologically active substance in one or more species for other 
species.  
(7) The Agency  concluded that the extrapolation of the existing entry  for rafoxanide  to all  
ruminants , except ovine , is appropriate . 
(8) In view of the opinion of the Agency , the Commission  considers  it appropriate to 
establish an MRL for rafoxanide  in bovine and ovine , in relation  to milk and to 
extrapolate the MRL  for rafoxanide  to all ruminants except ovine .  
(9) Regulation (EU) No 37/2010 should therefore be amended accordingly.  
(10) 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 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  
 The President   
 Ursula VON DER LEYEN