G/SPS/N/USA/3096/Add.1  
 
9 January 2023  
(23-0243) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
Addendum  
The following communication, received on 6 January 2023, is being circulated at the request of the 
Delegation of  the United States of America . 
 
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Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3; Final Rule  
The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide 
for the safe use of vitamin D3 as a nutrient supplement in breakfast cereals and grain -based bars 
(e.g., breakfast bars, granola bars, rice cereal bars), and to update the reference for the Vitamin D3 
specifications. We are taking this action in response to a petition filed by Kellogg Company (Kellogg).  
https://www.govinfo.gov/content/pkg/FR -2023-01-05/pdf/2022 -28428.pdf  
https://members.wto.org/crnattachments/202 3/SPS/USA/23_0265_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 circulation of the addendum to the notification and/or 
(dd/mm/yy) : This rule is effective 5 January 2023. The incorporation by reference of 
certain material listed in the rule is approve d by the Director of the Federal Register 
as of 5 January 2023. See section VIII for further information on the filing of 
objections. Either electronic or written objections and requests for a hearing on the 
final rule must be submitted by 6 February 2023.  
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:  
You may submit objections and requests for a hearing as follows. Ple ase note that late, untimely filed 
objections will not be considered. The https://www.regulations.gov  electronic filing system will accept 
objections until 11:59 p.m. Eastern Time at the end of 6 February 2023. O bjections received by 
mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are 
received on or before that date.  G/SPS/N/USA/3096/Add.1  
 
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  Submit electronic objections in the following way:  
Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting 
comments.  
Submit written/paper submissions as follows:  
Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), 
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.  
All submissions received must include the Docket No. FDA –2019–F–3519 for "Food Additives 
Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 ". Received objections, 
those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those 
submitted as "Confidential Submissions ", publicly viewable at https://www.regulations.gov  or at the 
Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, +(240) 402 7500.  
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. 88, No. 3, page 745 or on the internet at: 
https://www.govinfo.gov/content/pkg/FR -2023-01-05/pdf/2022 -28428.pdf . 
 
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