First, the FDA is revoking the authorisation for the use of methylene chloride as a diluent in inks for marking fruit and vegetables. Second, the FDA is revoking the authorisations for the use of methylene chloride, ethylene dichloride, and trichloroethylene in the manufacture of the following colour additives: annatto extract, paprika oleoresin, and turmeric oleoresin. These substances have no remaining authorised uses as colour additives or in the production of colour additives.
The FDA is revoking the authorisation for the use of methylene chloride as a diluent in inks for marking fruit and vegetables in response to a colour additive petition from the Environmental Defence 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 colour 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 authorisations for the use of methylene chloride, ethylene dichloride, and trichloroethylene in the production of the following colour additives: annatto extract, paprika oleoresin, and turmeric oleoresin in response to a colour additive petition from the International Association of Colour Manufacturers. The petitioner demonstrated that these uses have been abandoned by industry.
The effective date of the revocations is January 11, 2027.
