FDA drops three solvents from food color rules, one of them from produce inks on cancer grounds

The Food and Drug Administration has removed three solvents from its list of approved uses in food coloring. Under two final orders published in the Federal Register on November 10, methylene chloride, trichloroethylene and ethylene dichloride may no longer be used, from January 11, 2027, to extract the color additives annatto extract, paprika oleoresin and turmeric oleoresin. Methylene chloride also may no longer be used as a diluent in color mixtures for inks that mark fruit and vegetables.

On the evidence in FDA's orders, the change should mean little for products on sale today. FDA concluded that the extraction uses have been abandoned, and the color makers' association reported confirmations from ink manufacturers' and produce industry groups that their members do not make or import produce-marking inks containing methylene chloride. Because the annatto rules for drugs and cosmetics cross-reference the food rule, the extraction solvents will no longer be authorized for annatto in those products either, the agency says.

Two petitions, two legal routes

The decisions answer two petitions. The first, which FDA announced in January 2024, came from the Environmental Defense Fund, Breast Cancer Prevention Partners, the Center for Environmental Health, the Environmental Working Group and Lisa Lefferts. They asked FDA to remove the three solvents from four of its color additive rules under the Delaney Clause, the provision of food and drug law that deems a color additive unsafe if it is found to induce cancer in people or animals.

In its order on that petition, FDA agreed that all three solvents induce cancer in animals, citing studies sponsored by the National Toxicology Program. But it applied the clause only to the ink use, where FDA treats methylene chloride, mixed in as a diluent, as a color additive in its own right. In the extraction uses, any solvent left behind would be an impurity in the color, FDA says, and the Delaney Clause does not cover impurities. It denied those requests.

The second petition, from the International Association of Color Manufacturers, asked FDA to remove the same uses because industry had stopped using them. Its survey covered 44 companies and three trade associations representing another 375 companies, and all confirmed they had abandoned the solvents for these colors, according to FDA's order on that petition. The agency received no comments showing current use, granted the extraction part and called the ink request moot. Taken together, FDA wrote in its order on the environmental groups' petition, it "is taking all of the actions requested by the petitioners."

What the cancer finding does and does not mean

The studies FDA relied on were older animal tests: a 1978 National Cancer Institute report on ethylene dichloride in rats, a 1986 National Toxicology Program inhalation study that found liver and lung tumors in mice exposed to methylene chloride, and a National Cancer Institute bioassay concluding that trichloroethylene induces liver cancer in mice. Courts have read the Delaney Clause as "extraordinarily rigid," FDA notes, quoting a 1987 appeals court ruling, so a finding of cancer in animals bars a color additive regardless of how small the risk may be.

FDA stresses that the ink decision rests on that legal bar. It says the revocation is "not based on a finding that the intended use is no longer safe" under the law's general safety standard. For a past decision under the same clause, see our explainer on FDA's Red No. 3 order.

What comes next

Most comments on the environmental groups' petition supported it, FDA says. Some pointed to the Environmental Protection Agency's own moves to restrict trichloroethylene and methylene chloride; FDA answered that each agency regulates under its own legal authority. Anyone adversely affected can file objections and request a hearing until December 10, 2026. Both orders take effect on January 11, 2027, unless provisions are stayed by proper objections, in which case FDA says it will publish a notice in the Federal Register.