G/SPS/N/EU/648  
28 June 2023  
(23-4420) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Foodstuffs of animal origin  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Draft Commission Implementing Regulation 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) . Language(s):  English . Number of pages:  4 
https://members.wto.org/crnattachments/2023/SPS/EEC/23_10621_00_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_10621_01_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/EEC/23_10621_02_e.pdf  
6. Description of content:  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.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identif y the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international stand ard:  G/SPS/N/EU/648  
 
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  9. Other relevant documents and language(s) in which these are available:  
Opinion  of the Committee for Veterinary Medicinal Products on the establishment of 
maximum residue limits for the substance rafoxanide.  
10. Proposed date of adoption (dd/mm/yy) : November 2023  
Proposed date of publication (dd/mm/yy) : December 2023  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : Twenty days after publication in the Official Jou rnal of the European Union . 
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 27 August 2023  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
available) of other body:   
European Commission  
DG Health and Food Safety, Unit A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
European Commission  
DG Health and Food Safety, Unit A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu