G/SPS/N/USA/3368  
 
24 February 2023  
(23-1328) 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):  Inorganic or mineral colouring matter, n.e.s.; preparations based on 
inorganic or mineral colouring matter of a kind used for colouring a ny material or produce 
colorant preparations (excl. preparations of heading 3207, 3208, 3209, 3210, 3213 and 
3215); inorganic products of a kind used as luminophores, whether or not chemically 
defined (HS code(s): 3206); Food technology (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:  Filing of Color Additive Petition From Center for Science 
in the Public  Interest, et al.; Request To Revoke Color Additive Listing for Use of FD&C Red 
No. 3 in Food and Ingested Drugs; Petition for Rulemaking . Language(s):  English . 
Number of pages:  2 
https://www.govinfo.gov/content/pkg/FR -2023-02-17/pdf/2023 -03391.pdf  
6. Description of content:  The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by Center for Science in the Public Interest, et al., 
proposing that FDA repeal the color additive regulations providing for the use of FD&C Red 
No. 3 in fo ods (including dietary supplements) and in ingested drugs.  
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.   
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 
Anima l 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:   G/SPS/N/USA/3368  
 
- 2 - 
 
  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: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 18 April 2023 . The color additive petition was filed on 
15 November 2022. Either electronic or written comments must be submitted by 18 April 
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:   
Electronic Submissions  
Submit electronic comments in the following way:  
• Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for 
submitting comments. Comments submitted electronically, 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 that you or a third party may 
not wish to be post ed, 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 i n the body of your comment, that information will be 
posted on https://www.regulations.gov . 
• If you want to submit a comment with confidential information that you do not wish to 
be made available to t he public, submit the comment as a written/paper submission 
and in the manner detailed (see "Written/Paper Submissions" and "Instructions").  
Written/Paper Submissions  
Submit written/paper instructions as follows:  
• Mail/Hand Delivery/Courier (for written/pap er submissions): Dockets Management 
Staff (HFA –305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.  
• For written/paper comments submitted to the Dockets Management Staff, FDA will 
post your objection, as well as any attachme nts, except for information submitted, 
marked and identified, as confidential, if submitted as detailed in "Instructions".  
Instructions: All submissions received must include the Docket No. FDA – 2023–N–0437 for 
"Filing of Color Additive Petition from Cente r for Science in the Public Interest, et al.; 
Request to Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested 
Drugs". Received comments, those filed in a timely manner (see DATES), 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.  
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. 88, No. 33, Page 10245 or on the internet 
at: https://www.govinfo.gov/content/pkg/FR -2023-02-17/pdf/2023 -03391.pdf .