• On November 9, 2026, FDA announced that it would be revoking the authorization for the use of several substances in the production of color additives in response to color additive petitions submitted by the International Association of Color Additives (IACM) and a group including the Environmental Defense Fund, Breast Cancer Prevention Partners, Center for Environmental Health, Environmental Working Group, and Lisa Lefferts (EDF et al.).
  • EDF et al. petitioned FDA to revoke the authorization for the use of methylene chloride as a diluent in inks for marking fruits and vegetables under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prevents the Agency from authorizing an additive that has been found to cause cancer in humans or animals. According to FDA, the Group demonstrated that “this additive induces cancer in laboratory animals.” Based on studies cited in the petition, FDA determined that methylene chloride is an animal carcinogen. Therefore, as a matter of law, the substance is deemed unsafe.
  • The EDF et al. petition also included a request to remove ethylene dichloride, methylene chloride, and trichloroethylene from the list of authorized extraction solvents for annatto extract, paprika oleoresin, and turmeric oleoresin, but FDA denied this portion of the petition because residues of these substances would be impurities in the color additives, which are not subject to the Delaney Clause.
  • IACM petitioned FDA to revoke the authorization for the use of methylene chloride, ethylene dichloride, and trichloroethylene in the production of annatto extract, paprika oleoresin, and turmeric oleoresin. IACM’s petition demonstrated that industry has abandoned these uses. The petition also requested that FDA remove the use of methylene chloride as a diluent in color additive mixtures in inks for marking fruit and vegetables. However, FDA denied this request as moot because the Agency revoked authorization of this use of the substance in response to the EDF et al. petition.
  • Keller and Heckman will continue to monitor updates related to food and color additive authorizations.