Nov 10, 2026 The Food and Drug Administration announced two separate actions to revoke the authorizations of certain substances used as color additives or in the production of color additives.
First, the FDA is revoking the authorization for the use of methylene chloride as a diluent in inks for marking fruit and vegetables. Second, the FDA is revoking the authorizations for the uses of methylene chloride, ethylene dichloride, and trichloroethylene in the manufacture of the following color additives: annatto extract, paprika oleoresin, and turmeric oleoresin. These substances have no remaining authorized uses as color additives or in the production of color additives.
The FDA is revoking the authorization for the use of methylene chloride as a diluent in inks for marking fruit and vegetables in response to a color additive petition from the Environmental Defense Fund, Breast Cancer Prevention Partners, Center for Environmental Health, Environmental Working Group, and Lisa Lefferts. The petition requested revocation on the basis of the Delaney Clause of the Federal Food, Drug & Cosmetic Act. Under the Delaney Clause, a color additive that is ingested (such as when used in food) must be deemed unsafe if that substance has been found to induce cancer in humans or animals. Methylene chloride has been shown to cause cancer in laboratory animals.
The FDA is revoking the authorizations for the use of methylene chloride, ethylene dichloride, and trichloroethylene in the production of the following color additives: annatto extract, paprika oleoresin, and turmeric oleoresin in response to a color additive petition from the International Association of Color Manufacturers. The petitioner demonstrated that these uses have been abandoned by industry.
The effective date of the revocations is January 11, 2027.
Additional Information
- Federal Register Notice (Color Additive Petition Response – EDF)
- Federal Register Notice (Color Additive Petition Response – IACM)
- Final Rules and Final Orders: Food Additives and Color Additives
- Food Chemical Safety
- How the FDA Ensures Impurities in Food Additives and Color Additives Are Safe for Consumers
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Source: US Food and Drug Administration
