EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/2438 CIS 
(POOL/D4/2023/2438/2438 -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 
sodium salicylate 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 
sodium salicylate 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 Eu ropean 
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) Table 1 of the Annex to Commission Regulation (EU) No 37/20102 sets out the 
pharmacologically active substances and their classification regarding maximum 
residue limits (‘ MRLs ’) in foodstuffs of animal origin.  
(2) The substance sodium salicylate  is included in that table as an allowed substance.  
(3) On 30 September  2022, pursuant to  Article 3 of Regulation (EC) No  470/2009 , 
Dopharma B.V.  submitted  an application to the European Medicines Agency 
('Agency') for the extension of the existing entry for the substance sodium salicylate  to 
chicken . 
(4) On 5 October  2023, the Agency, based on the opinion of the Committee for Veterinary 
Medicinal Products , set up pursuant to Article 139 of Regulation (EU) 2019/6 of the 
European Parliament and of the Council3, and having considered the application of 
Dopharma B.V. , recomme nded the extension of maximum residue limits for the 
substance sodium salicylate  in chicken  and the establishment of numerical MRLs . 
(5) The Agency also concluded that the extrapolation of the MRLs for sodium salicylate  
from chicken tissues to the tissues of o ther poultry species other than turkey is 
appropriate.  
(6) In view of the o pinion of the Agency , the Commission  consider s it appropriate to 
establish the recommended MRL for sodium salicylate  in chicken tissues and to 
 
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).  
3 Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on 
veterinary medicinal products and repealing Directive 2 001/82/EC (OJ L 4, 7.1.2019, p. 43 ).  
EN 2  EN extrapolate it to other poultry species  other than turkey , but restricted to animals not 
producing eggs for human consumption as no residue data were provided for eggs .  
(7) Regulation (EU) No 37/2010 should therefore be amended accordingly.  
(8) The measures provided for in this Regulation are i n 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,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN