G/SPS/N/USA/3305  
28 January 2022  
(22-0712) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  UNITED STATES OF AMERICA  
If applicable, name of local government involved:   
2. Agency responsible:  Food and Drug Administration (FDA)  
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):  HS Code(s): 3923, 3924,  4811; ICS Code(s): 67  
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:  Food Additives: Food Contact Substance Notification 
That Is No Longer Effective; Proposed Rule . Language(s):  English . Number of 
pages:  10 
https://www.govinfo.gov/content/pkg/FR -2022-01-26/pdf/2022 -01527.pdf  
https://members.wto.org/crnattachments/2022/SPS/USA/22_1012_00_e.pdf  
6. Description of content:  The Food and Drug Administration (FDA or we) is proposing to 
amend its regulations relating to the procedures by which we determine that a premarket 
notification for a food contact substance (FCN) is no longer effective. The proposed rule, if 
finalized, would, among other things, ensure that manufacturers or suppliers have the 
opportunity to provide input before we could determine that an FCN is no longer effective. 
The proposed rule also would provide additional reasons that could be the basis for FDA to 
determine that an FCN is no longer effective. We are proposing th ese changes to better 
enable FDA to respond to new information on the safety and use of food contact 
substances, as well as manufacturers' business decisions, which would also improve our 
FCN program's efficiency.  
7. Objective and rationale: [X]  food safe ty, [ ] 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, identify the standard:  
[ ] Codex Alimentarius Com mission (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/USA/3305  
 
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  [ ] Yes   [  ] No 
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) : Not applicable  
Proposed date of publication (dd/mm/yy) : Not applicable  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : Not applicable  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 29 March 2022  
Agency or authority designated to handle comments: [  ] National Notification 
Authority, [  ] National Enquiry Point. Address, fax number and e -mail address (if 
available) of other body:   
Submit electronic comments in the following way:  
• Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for 
submitting comments. Comments submitted el ectronically, including attachments, to 
https:// www.regulations.gov will be posted to the docket unchanged. Because your 
comment will be made public, you are solely responsible for ensuring that your 
comment does not include any confidential information t hat you or a third party may 
not wish to be posted, such as medical information, your or anyone else's Social 
Security number, or confidential business information, such as a manufacturing 
process. Please note that if you include your name, contact informa tion, or other 
information that identifies you in the body of your comments, that information will 
be posted on https://www.regulations.gov .  
• If you want to submit a comment with confidential informat ion that you do not wish 
to be made available to the public submit the comment as a written/ paper 
submission and in the manner detailed (see "Written/Paper Submissions " and 
"Instructions "). 
13. Text(s) available from: [  ] National Notification Authority, [  ] National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
Text can be found in the Federal Register, Vol. 87, No. 17, Page  3949 or on the internet 
at: https://www.govinfo.gov/content/pkg/FR -2022-01-26/pdf/2022 -01527.p df