G/SPS/N/USA/3214/Add.1  
 
30 September 2022  
(22-7364) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
Addendum  
The following communication, received on 29 September 2022, is being circulated at the request of 
the Delegation of  the United States of America . 
 
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Listing of Color  Additives Exempt From Certification; Calcium Carbonate; Final Rule  
The Food and Drug Administration (FDA or we) is amending the color  additive regulations to provide 
for the safe use of calcium carbonate in dietary supplement tablets and capsules. We are taking this 
action in response to a color additive petition (CAP) submitted by Colorcon, Inc. (Colorcon or 
petitioner). This rule is e ffective 28 October 2022.  
https://www.govinfo.gov/content/pkg/FR -2022-09-27/pdf/2022 -20819.pdf  
https://members.wto.org/crnattachments/2022/SPS/USA/22_6647_00_f.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) : Submit either electro nic or written objections and requests for a hearing 
on the final rule by 27 October 2022. See section XI for further information on the 
filing of objections.  
Agency or authority designated to handle comments: [  ] National Notification Authority, 
[ ] Nati onal 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. Please note that late, untimely filed 
objections will not be considered. The https://www.regulations.gov  electronic filing system will accept 
comments until 11:59 p.m. Eastern Time at the end of 27 October 2022. Objections 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/3214/Add.1  
 
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  Electronic Submissions  
Submit electronic objections in the following way:  
• Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting 
comments. Objections submitted electronically, including attachments, to 
https://www.regulations.gov  will be posted to the docket unchanged. Because your objection will 
be made public, you are solely r esponsible for ensuring that your objection does not include any 
confidential information that 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 information, 
or other information that identifies you in the body of your objection, that information will be 
posted on https:// www.regulations.gov . 
• If you want to submit an objection with confidential information that you do not wish to be made 
available to the public, submit the objection as a written/paper submission and in the manner 
detailed (see "Written/Paper Submissions" and "Instructions").  
 
Written/Paper Submissions  
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. 1 061, Rockville, MD 20852.  
• For written/paper objections submitted to the Dockets Management Staff, FDA will post your 
objection, as well as any attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed i n "Instructions".  
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. 186, Page 58445 or on the internet at: 
https://www.govinfo.gov/content/pkg/FR -2022-09-27/pdf/2022 -20819.pdf . 
 
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