G/SPS/N/UKR/186  
6 September 2022  
(22-6638) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member:  UKRAINE  
If applicable, name of local government involved:   
2. Agency responsible:  Ministry of Health of Ukraine  
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):  Release of the N -nitrosamines and N -nitrosatable substances from 
elastomer or rubber teats and soothers  
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 Order of the Ministry of Health of Ukraine "On 
approval of the Criteria for release of the N -nitrosamin es and N -nitrosatable substances 
from elastomer or rubber teats and soothers" . Language(s):  Ukrainian . Number of 
pages:  4 
https://beta.m oz.gov.ua/uploads/ckeditor/%D0%93%D1%80%D0%BE%D0%BC%D0%
B0%D0%B4%D1%81%D1%8C%D0%BA%D0%B5%20%D0%BE%D0%B1%D0%B3%D
0%BE%D0%B2%D0%BE%D1%80%D0%B5%D0%BD%D0%BD%D1%8F/2022/08/18/
%D0%9D%D0%B0%D0%BA%D0%B0%D0%B7.pdf  
https://members.wto.org/crnattachments/2022/SPS/UKR/22_5985_00_x.pdf  
https://members.wto.org/crnattachments/2022/SPS/UKR/22_5985_01_x.pdf  
6. Description of content:  The draft Order provides for the approval of the Criteria for the 
release of N -nitrosamines and N -nitrosatable substances from elastomer or rubber teats 
and soothers and prohibits, as of 1 January 2024, the sale and use of elastomer or rubber 
teats and soothers that do not meet the safety requirements set forth in Section II of the 
Criteria.  
The Criteria set requirements for certain safety indicators for ru bber and elastomeric teats 
and soothers and apply to the release of N -nitrosamines and substances that can be 
converted to N -nitrosamines from teats and soothers made of elastomer or rubber.  
The draft Order harmonizes the provisions of Commission Directive  93/11/EEC of 
15 March  1993 concerning the release of the N -nitrosamines and N -nitrosatable 
substances from elastomer or rubber teats and soothers in order to ensure a high level 
of protection for the children's health.  
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.  Safety of products that come into contact with foodstuffs, 
protection for the children's health . G/SPS/N/UKR/186  
 
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  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?  
[ ] 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:  Law of 
Ukraine "On the Basic Principles and Requirements for Food Safety and Quality"  (available 
in Ukranian)  
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: [X]  Six months from date of publication , 
and/or  (dd/mm/yy) :  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 30 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:   
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: