Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Final Rules: Food Additives and Color Additives
  • Print
  • Share
  • E-mail
-

Petition(s): CAP 3C0323

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

Petitioner: Center for Science in the Public Interest, Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Chef Ann Foundation, Children's Advocacy Institute, Consumer Federation of America, Consumer Reports, Defend Our Health, Environmental Defense Fund, Environmental Working Group, Feingold Association of the United States, Food & Water Watch, Healthy Babies Bright Futures, Life Time Foundation, Momsrising, Prevention Institute, Public Citizen, Public Health Institute, Public Interest Research Group, Real Food for Kids, Lisa Y. Lefferts, Linda S. Birnbaum, and Philip J. Landrigan
Docket number (legacy and/or former docket number(s)): FDA-2023-N-0437
Subject additive and intended use: Repealing the color additive regulations that permit the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs.
21 CFR* affected: 74.303; FD&C Red No. 3 (Food); revocation effective January 15, 2027†
74.1303; FD&C Red No. 3 (Drugs); revocation effective January 18, 2028†
Substance(s)*, (CAS Registry® No.):
  • FD&C Red No. 3, (16423-68-0)
    		•
    Federal Register publication history: Feb 17, 2023; 88 FR 10245; Petition for rulemaking
    Mar 30, 2023; 88 FR 19026; Petition for rulemaking; extension of comment period
    Jan 16, 2025; 88 FR 19026; Final amendment; order.

    † Objections may be submitted until February 18, 2025; any objections could stay the regulations

     

    *Definitions

    • 21 CFR: Title 21 of the Code of Federal Regulations.
    • Substance: The name of the substance listed in the CFR.
    • CAS Registry® No.: Chemical Abstract Service (CAS) Registry Number® for the substance.
    • Petitions (see also Questions and Answers About the Petition Process)
      • FAP: Food Additive Petition
      • CAP: Color Additive Petition
      • GRP: GRAS Affirmation Petition (replaced by GRAS Notification Program in 1998)
    -
    -