G/SPS/N/EU/478  
 
6 April 2021  
(21-2834) 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):  Animals and produ cts 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 Delegated Regulation supplementing 
Regulation (EU) 2019/6 of the European Parliament and of the Council by establishing the 
criteria for the designation of antimicrobials to be reserved for the treatment of certain 
infections in humans . Language(s):  English . Number of pages:  7 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_2284_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_2284_01_e.pdf  
6. Description of content:  This draft Commission Delegated Regulation aims to define 
criteria for the designation of antimicrobials to be reserved for the treatment of certain 
infections in humans. It will serve as a basis for a forthcoming Commission Implementing 
Regulation establishing a list of antimicrobials to be reserved for the treatment of certain 
infections in humans. Such antimicrobials shall not be used in animals or products of 
animal origin to be imported into the European Union, in accordance with Article 118 of 
Regulation (EU) 2019/6.  
7. Objective and rationale: [  ] food safety, [  ] animal health, [  ] plant protection, 
[X] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commissi on (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 G/SPS/N/EU/478  
 
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  If no, describe, whenever possible, how and why it deviates from the 
international stand ard:  
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of adoption (dd/mm/yy) : To be determined.  
Proposed date of publication (dd/mm/yy) : To be determined.  
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : 28 January 2022  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Thirty days from the date of circulation of the 
notification.  
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 D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
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 D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu