IN Brief:
- The FDA is withdrawing methylene chloride authorisation as a diluent in inks used to mark fruit and vegetables.
- Separate amendments remove three previously authorised extraction solvents from manufacturing rules for annatto, paprika and turmeric oleoresins.
- Both actions take effect on 11 January 2027; the FDA says the extraction-solvent uses had already been abandoned by industry.
The US Food and Drug Administration has issued two actions withdrawing authorisations for chemicals previously permitted in certain colour-additive applications. One removes the use of methylene chloride as a diluent in inks for marking fruit and vegetables. The other eliminates three solvents from the rules governing the manufacture of annatto extract, paprika oleoresin and turmeric oleoresin. Both revocations take effect on 11 January 2027.
The actions follow different legal routes. For fruit-marking inks, a consumer-group petition relied on the Delaney Clause, which governs carcinogenic colour additives, and on evidence that methylene chloride induces cancer in laboratory animals. An industry petition concerning extraction solvents took a different route: the International Association of Color Manufacturers supplied evidence that the listed uses had been abandoned. Both outcomes narrow historical permissions, but neither withdraws approval for annatto extract, paprika oleoresin, or turmeric oleoresin themselves.
Methylene chloride, also known as dichloromethane, had remained in the regulations as an authorised diluent for certain colour-additive ink mixtures used to print information on produce. A diluent helps adjust the properties of an ink system so that it can be applied by the intended marking process. The revocation removes that regulatory permission, rather than announcing a new mandatory marking method for fruit and vegetables or a restriction on all inks used on produce.
The fruit-marking petition came from the Environmental Defense Fund, Breast Cancer Prevention Partners, Center for Environmental Health, Environmental Working Group, and Lisa Lefferts. The FDA concluded that methylene chloride’s use as an ink diluent falls within the colour-additive provisions to which the Delaney Clause applies. That provision treats an ingested colour additive as unsafe where it has been found to induce cancer in people or animals. The agency cited animal carcinogenicity evidence for methylene chloride and removed that specific permitted use in produce-marking inks.
The extraction-solvent amendments concern the manufacture of annatto extract, paprika oleoresin, and turmeric oleoresin, which obtain colour from plant-derived materials. The affected solvent names are methylene chloride, ethylene dichloride, and trichloroethylene. Solvents may be used in extraction and subsequently removed through processing, but the nature of their residues and permissible manufacturing routes are controlled by ingredient specifications. The FDA says the particular uses covered by the amendments had already been permanently abandoned by industry, rather than describing a newly detected contamination incident.
The three solvents formerly appeared in manufacturing provisions for particular plant-derived colourants. Their removal changes the permitted extraction procedures named in those provisions; it does not withdraw the authorisation of the colourants themselves. Ingredient specifications may continue to set identity, purity and residue requirements independently of the deleted solvent listings. The FDA has not reported recalls or product withdrawals associated with the amended permissions, and its published explanation points to historical uses that industry had already ceased.
The International Association of Color Manufacturers supported removal of the obsolete extraction-solvent permissions through a separate petition. In its corresponding legal order, the FDA distinguished the solvent uses from the colour additives themselves: residues of extraction solvents are treated as impurities, so the Delaney Clause does not directly provide the basis for striking those processing permissions. The agency instead acted on the evidence of abandonment. That distinction explains why the two measures were issued separately even though some chemical names appear in both.
Ingredient specifications, certificates, and supplier declarations may still refer to the regulatory provisions being amended. A change in a historical permission does not establish that current batches contain the solvent or that production methods must now change. Any compliance review should begin with the supplier’s actual extraction process and the intended food application. The FDA has not quantified how many manufacturers will need to revise documentation or make further process changes.
Fruit-marking ink suppliers face a different check because the agency removed methylene chloride as a specifically authorised ink diluent. An ink’s performance depends on application viscosity, drying, adhesion, and the produce surface, but the order does not mandate a particular alternative formulation or marking machine. Businesses using such materials will need to establish whether the withdrawn permission remains relevant to their purchased inks. The FDA has not identified a number of current users or a replacement technology in the final action.
The revocations also differ from broader policy discussions about synthetic food dyes. Here, the chemicals removed from the regulations are associated with a fruit-marking ink or with historical extraction processes for specified natural colour preparations. The colour-producing ingredients continue to have their own regulatory status and specifications. Treating the announcement as a blanket ban on annatto, paprika and turmeric colouring would misstate both the scope of the actions and the likely consequences for food processors.
Both orders are scheduled to take effect on 11 January 2027, subject to any legally effective delay or stay following objections. The deadline for objections and hearing requests is 10 December 2026. For ingredient buyers, the relevant distinction is between removal of an abandoned extraction route and removal of a fruit-ink diluent on the basis of the colour-additive law. The unchanged regulatory status of the named plant colourants and the absence of a reported recall should keep procurement reviews focused on actual supplier processes and specifications.
