G/SPS/N/EU/557  
 
21 April 2022  
(22-3194) 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 products 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:  COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX designating antimicrobials or groups of antimicrobials reserved for treatment of 
certain inf ections in humans, in accordance with Regulation (EU) 2019/6 of the European 
Parliament and of the Council (Text with EEA relevance) . Language(s):  English . Number 
of pages:  7 in total (4+3)  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_2956_00_e.pdf  
https://members.wto.org/crnattachments/2022/SPS/EEC/22_2956_01_e.pdf  
6. Description of content:  This draft Commission Implementing Regulation designates 
antimic robials or groups of antimicrobials to be reserved for the treatment of certain 
infections in humans. It is based on the criteria established in Commission Delegated 
Regulation (EU) 2021/1760 for the designation of antimicrobials to be reserved for the 
treatment of certain infections in humans. Such antimicrobials or groups of antimicrobials 
must not be used in animals in the European Union and 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 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?  G/SPS/N/EU/557  
 
- 2 - 
 
  [ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
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) : To be determined.  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 20 June 2022  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
avail able) 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