The FDA Is Removing a Chemical Authorization for Inks Used to Mark Fruits and Vegetables

The FDA said on November 9 that it is revoking the authorization for methylene chloride as a diluent in inks used to mark fruits and vegetables. The change takes effect January 11, 2027, and it is a regulatory action, not a recall of produce already in stores.

What the FDA changed

The agency announced two related color additive actions this week. The first removes the authorized use of methylene chloride in color additive mixtures used as inks for marking fruits and vegetables. The FDA said it took that step in response to a color additive petition filed by the Environmental Defense Fund, Breast Cancer Prevention Partners, Center for Environmental Health, Environmental Working Group, and Lisa Lefferts.

In its notice, the FDA said the petition asked the agency to revoke the authorization under the Delaney Clause in the Federal Food, Drug, and Cosmetic Act. The agency said a color additive that is ingested must be deemed unsafe under that clause if it has been found to induce cancer in humans or animals. The FDA said methylene chloride has been shown to cause cancer in laboratory animals.

This is a rule change about what can be authorized going forward, not an announcement that shoppers should throw out fruit or vegetables in their kitchens. The FDA framed it as the removal of an authorized use in its color additive regulations. For home cooks, the practical point is that the action targets a food contact use tied to produce markings, not the produce itself.

Why the Delaney Clause mattered

The Delaney Clause plays a narrow but important role in this decision. According to the FDA, it applies to color additives that are ingested in food. Because produce marking inks are used on fruits and vegetables, the agency treated the methylene chloride authorization as falling within that standard.

The FDA also used this announcement to explain a separate limit of the Delaney Clause. In a related action, the agency said it was denying part of the same petition that sought to remove certain solvents from the production of annatto extract, paprika oleoresin, and turmeric oleoresin on Delaney Clause grounds. The FDA said any leftover solvent in those color additives would be considered an impurity, and impurities are not subject to the Delaney Clause.

That distinction helps explain why the produce ink action and the color additive manufacturing actions were handled differently. One involved an authorized use of methylene chloride in an ingested color additive application. The other involved substances used during production, which the FDA said are evaluated under a different safety framework for impurities.

Separate changes for annatto, paprika, and turmeric

The FDA announced a second action at the same time, covering methylene chloride, ethylene dichloride, and trichloroethylene used in producing annatto extract, paprika oleoresin, and turmeric oleoresin. In that action, the agency said it was revoking those authorizations on the basis of abandonment after a petition from the International Association of Color Manufacturers.

According to the FDA, the petitioner demonstrated that those uses had been abandoned by industry. The agency said those substances now have no remaining authorized uses as color additives or in the production of color additives. A Federal Register notice also said the request to remove methylene chloride from produce marking inks on abandonment grounds was moot because that authorization had already been removed in response to the separate Delaney Clause petition.

For shoppers and home cooks, the biggest takeaway is timing and scope. The effective date for the revocations is January 11, 2027. The announcement does not describe a recall, does not say fruits and vegetables currently in supermarkets are being pulled, and does not direct consumers to take any action with produce already purchased.

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