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

Petition(s): CAP 4C0327

Request to Amend the Color Additive Regulations to Remove the Solvents Ethylene Dichloride, Methylene Chloride, and Trichloroethylene

Petitioner: Environmental Defense Fund, Breast Cancer Prevention Partners, Center for Environmental Health, Environmental Working Group, and Lisa Lefferts
Docket number (legacy and/or former docket number(s)): FDA-2023-C-5679
Subject additive and intended use: amending our color additive regulations, on the basis of the Delaney Clause, to remove the authorized use of methylene chloride as a diluent in color additive mixtures in inks for marking fruit and vegetables. The petitioners provided data demonstrating that this additive induces cancer in laboratory animals. We are denying the remaining petition requests to remove ethylene dichloride, methylene chloride, and trichloroethylene from the list of authorized extraction solvents for annatto extract, paprika oleoresin, and turmeric oleoresin, because any residue of the solvent would be an impurity in the color additive and such impurities are not subject to the Delaney Clause.
21 CFR* affected: 73.1; Diluents in color additive mixtures for food use exempt from certification.
Substance(s)*, (CAS Registry® No.):
  • methylene chloride, (75-09-2)
    		•
    Federal Register publication history: Jan 11, 2024; 89 FR 1856; Notification of petition.
    May 28, 2026; 91 FR 31680; Notification of petition; reopening of the comment period.
    Nov 10, 2026; 91 FR 72413; Final amendment; order; notification of partial denial of petition.†

    † Objections may be submitted until 12/10/2026; 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)
    -
    -