The U.S. Food and Drug Administration has partially granted a color additive petition from the International Association of Color Manufacturers (IACM), according to a notice published in the Federal Register on November 10, 2026. The amendments delete the entries for ethylene dichloride, methylene chloride and trichloroethylene from the authorized extraction solvents in 21 CFR 73.30(a)(1)(ii), 73.345(a)(1) and 73.615(a)(1). Those sections cover annatto extract, paprika oleoresin and turmeric oleoresin, respectively.
At a glance
- FDA's notice, published November 10, 2026, partially grants IACM's color additive petition and removes three extraction solvents from the rules for annatto extract, paprika oleoresin and turmeric oleoresin.
- FDA said the basis is abandonment of the solvent uses, supported by petition data, an IACM survey summary and one supporting comment.
- The request on methylene chloride in inks for marking fruit and vegetables was denied as moot because a separate order had already removed that authorization.
FDA said the change rests on abandonment. After reviewing the petition data and other available relevant material, the agency determined that these solvent uses in making color additives have been abandoned. FDA said the petitioner supplied data showing the uses have been permanently abandoned.
FDA described a survey summary in the IACM petition that covered 44 unique companies and three trade associations. The three associations collectively represent an additional 375 companies. The petitioner stated that every participating company confirmed it had abandoned the three solvents for making annatto extract, paprika oleoresin and turmeric oleoresin.
FDA announced the filing of the petition, designated CAP 5C0340, in the Federal Register of April 1, 2026 (91 FR 16169). Interested parties had 60 days, until June 1, 2026, to comment. FDA said it received one comment supporting the petitioner's conclusion that the described solvent uses have been abandoned, and no other comments. The agency also said it received no comments demonstrating current use of the solvents in making these color additives.
FDA stated that removing the solvents from section 73.30 also ends their authorization under 21 CFR 73.1030, covering annatto extract for drugs, and 73.2030, covering annatto for cosmetics. Those two sections had authorized the solvents only by cross-referencing section 73.30(a)(1), and their regulatory text will not be amended.
The petition was granted only in part. FDA denied as moot the request to remove methylene chloride as a diluent in color additive mixtures in inks for marking fruit and vegetables (21 CFR 73.1). The agency said that authorization was already removed on the basis of the Delaney Clause, in a separate final order in the same Federal Register issue responding to petition CAP 4C0327.