FDA Revokes Authorizations for Methylene Chloride and Two Other Substances Used in Color Additives, Effective January 11, 2027
WASHINGTON — The U.S. Food and Drug Administration (FDA) announced two separate actions in Washington on November 9 to revoke the authorizations of certain substances used as color additives or in the production of color additives, with the revocations taking effect on January 11, 2027.
In the first action, the FDA is revoking the authorization for the use of methylene chloride as a diluent in inks for marking fruit and vegetables. In the second, the agency is revoking the authorizations for the uses of methylene chloride, ethylene dichloride and trichloroethylene in the manufacture of three color additives: annatto extract, paprika oleoresin and turmeric oleoresin. The FDA said these substances have no remaining authorized uses as color additives or in the production of color additives.
The first revocation responds to a color additive petition from the Environmental Defense Fund, Breast Cancer Prevention Partners, the Center for Environmental Health, the Environmental Working Group and Lisa Lefferts. The petition invoked the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, under which a color additive that is ingested must be deemed unsafe if the substance has been found to induce cancer in humans or animals. Methylene chloride has been shown to cause cancer in laboratory animals.
The second revocation responds to a petition from the International Association of Color Manufacturers, which demonstrated that these uses have been abandoned by industry.
(Source: U.S. Food and Drug Administration)
Source: U.S. Food and Drug Administration
Published by GSM · USA (original Chinese edition)
Photo: 图：美国食品药品管理局总部大楼（GSM 固定图库）。 / Photo: U.S. Food and Drug Administration headquarters (GSM asset library).
