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U.S. Department of Health and Human Services

Final Rules and Final Orders: Food Additives and Color Additives
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Petition(s): CAP 5C0340

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

Petitioner: International Association of Color Manufacturers
Docket number (legacy and/or former docket number(s)): FDA-2026-C-3071
Subject additive and intended use: amending our color additive regulations, on the basis of abandonment, to remove the authorized uses of methylene chloride, trichloroethylene, and ethylene dichloride from the list of authorized extraction solvents for annatto extract, paprika oleoresin, and turmeric oleoresin. The petitioner provided data demonstrating that these uses have been permanently abandoned. FDA is denying as moot the portion of the petition proposing that the color additive regulations be amended, on the basis of abandonment, to no longer authorize the use of methylene chloride as a diluent in color additive mixtures in inks for marking fruit and vegetables. This request is moot because the authorization for this use has been removed, on the basis of the Delaney Clause, in response to a separate petition.
21 CFR* affected: 73.30; Annatto extract.
73.345; Paprika oleoresin.
73.615; Turmeric oleoresin.
Substance(s)*, (CAS Registry® No.):
  • ethylene dichloride, (107-06-2)
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  • methylene chloride, (75-09-2)
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  • trichloroethylene, (79-01-6)
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    Federal Register publication history: Apr 1, 2026; 91 FR 16169; Notification of petition.
    Nov 10, 2026; 91 FR 72410; 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)
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