   
  
G/SPS/N/EU/478/Add.1  
 
29 October  2021 
(21-8232) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
Addendum  
The following communication, received on 28 October 2021, is being circulated at the request of the 
Delegation of  the European Union . 
 
_______________  
 
 
Criteria for the designation of antimicrobials to be reserved for the treatment of certain infections in 
humans  
The proposal notified in G/SPS/N/EU/478 (6 April 2021) is now adopted by Commission Delegated 
Regulation (EU) 2021/1760 of 26 May 2021 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 (Text with EEA relevance) [OJ L 353, 
6 October 2021, p. 1].  
The Regulation shall apply from 28  January 2022.  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_6869_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_6869_00_f.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_6869_00_s.pdf  
This addendum concerns a:  
[ ] Modification of final date for comments  
[X] Notification of adoption, publication or entry into force of regulation  
[ ] Modification of content and/or scope of previously notified draft regulation  
[ ] Withdrawal of proposed regulation  
[ ] Change in proposed date of adoption, publication or date of entry into force  
[ ] Other:  
Comment period: (If the addendum extends the scope of the previously notified measure 
in terms of products and/or potentially affected Members, a new deadline for receipt of 
comments should be provided, normally of at least 60 calendar days. Under other 
circumstances, such as extension of originally announced final date for comments, the 
comment period provided in the  addendum may vary.)  
[ ] Sixty days from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy) : Not applicable  
Agency or authority designated to handle comments: [X]  National Notification Authority, 
[X] National Enquiry Point. Add ress, 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  G/SPS/N/EU/478/Add.1  
 
- 2 - 
 
  Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.euro pa.eu  
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  
 
__________  