Color Additive Petition From Environmental Defense Fund et al.; Request To Amend the Color Additive Regulations To Remove the Solvents Ethylene Dichloride, Methylene Chloride, and Trichloroethylene

Official abstract: The Food and Drug Administration (FDA or we) is partially granting a color additive petition submitted by Environmental Defense Fund et al. (petitioners), by amending our color additive regulations, on the basis of the Delaney Clause, to remove the authorized use of methylene chloride as a diluent in color additive mixtures in inks for marking fruit and vegetables. The petitioners provided data demonstrating that this additive induces cancer in laboratory animals. We are denying the remaining petition requests to remove ethylene dichloride, methylene chloride, and trichloroethylene from the list of authorized extraction solvents for annatto extract, paprika oleoresin, and turmeric oleoresin, because any residue of the solvent would be an impurity in the color additive and such impurities are not subject to the Delaney Clause.