   
  
G/SPS/N/USA/3305/Add.1  
27 March 2024  
(24-2620) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
Addendum  
The following communication, received on 26 March 2024, is being circulated at the request of the 
Delegation of  the United States of America . 
 
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Food Additives: Food Contact Substance Notification That Is No Longer Effective; Final Rule  
The Food and Drug Administration (FDA or we) is amending its regulations relating to the procedures 
for determining that a premarket notification for a food contact substance (FCN) is no longer effective. 
The final rule provides additional reasons that could form the basis for FDA to determine that an FCN 
is no longer effective. The final rule also ensures that manufacturers or suppliers have the opportunity 
to provide input before we determine t hat an FCN is no longer effective. We are making these changes 
to allow FDA to respond better to new information on the safety and use of food contact substances 
(FCSs), as well as manufacturers' business decisions, and also improve the efficiency of the p remarket 
notification program.  
This rule is effective 21 May 2024.  
https://www.govinfo.gov/content/pkg/FR -2024-03-22/pdf/2024 -05802.pdf  
https://members.wto.org/crnattachments/2024/SPS/USA/24_02270_00_e.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 circula tion of the addendum to the notification and/or 
(dd/mm/yy) : Not applicable  
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: 
For access to the docket to read background documents or comments received, go to 
https://www.regulations.gov  and insert the docket number found in brackets in the heading of this G/SPS/N/USA/3305/Add.1  
 
- 2 - 
 
  final rule into the "Search" box and follow the prompts, and/or go to the Dockets Management Staff, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, +(240) 402 7500.  
For further information contact: Sharon Koh -Fallet, Center for Food Safety and Ap plied Nutrition 
(HFS–275), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, +(301) 796 
7732; or Carrol Bascus, Center for Food Safety and Applied Nutrition (HFS –024), Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 207 40, +(240) 402 2378.  
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. 89, No. 57, Page 20306 or on the internet at: 
https://www.govinfo.gov/content/pkg/FR -2024-03-22/pdf/2024 -05802.pdf . 
 
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