FDA Revokes Authorizations for Certain Chemicals Used in Food Color Additives
The U.S. Food and Drug Administration (FDA) has announced two actions to revoke authorizations for certain chemicals used as color additives or in the production of color additives, including methylene chloride, ethylene dichloride, and trichloroethylene.
Specifically, FDA is revoking the authorization for the use of methylene chloride as a diluent in inks used to mark fruits and vegetables, as well as the authorizations for the use of methylene chloride, ethylene dichloride, and trichloroethylene in the manufacture of annatto extract, paprika oleoresin, and turmeric oleoresin.
Both revocations will take effect on January 11, 2027. The substances have no remaining authorized uses as color additives or in the production of color additives.
Methylene Chloride Authorization Revoked Under Delaney Clause
FDA is revoking the authorization for methylene chloride as a diluent in inks used to mark fruits and vegetables in response to a color additive petition submitted by the Environmental Defense Fund, Breast Cancer Prevention Partners, the Center for Environmental Health, the Environmental Working Group, and an environmental health consultant.
The petition requested revocation under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which requires that an ingested color additive be deemed unsafe if it has been found to induce cancer in humans or animals. Methylene chloride has been shown to cause cancer in laboratory animals.
Industry Abandonment of Chemicals Used in Color Additive Production
Separately, FDA is revoking the authorizations for the use of methylene chloride, ethylene dichloride, and trichloroethylene in the manufacture of annatto extract, paprika oleoresin, and turmeric oleoresin.
The action was taken in response to a color additive petition submitted by the International Association of Color Manufacturers, which demonstrated that these uses have been abandoned by industry.
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