FDA Revokes Methylene Chloride Approval for Produce Inks and Color Additive Solvents

The Food and Drug Administration has revoked authorization for methylene chloride in inks used to stamp fruits and vegetables, along with three industrial solvents previously permitted in the production of annatto, paprika, and turmeric color additives. The changes, announced November 9, take effect January 11, 2027, according to an FDA constituent update.

Following the revocation, these substances will have no remaining authorized uses as color additives or in their manufacture.

While the practical impact on consumers is limited, the decision removes cancer-linked solvents from the federal list of approved color uses. Notably, methylene chloride’s separate approval for decaffeinating coffee remains in place for now.

Two Petitions Prompted the Action

The FDA acted on two distinct petitions. The first came from a coalition including the Environmental Defense Fund, Breast Cancer Prevention Partners, the Center for Environmental Health, the Environmental Working Group, and scientist Lisa Lefferts. They requested the agency end methylene chloride’s use as a diluent in fruit and vegetable marking inks.

That petition invoked the Delaney Clause, a federal food law provision requiring a color additive to be deemed unsafe if found to cause cancer in humans or animals. The FDA acknowledged that methylene chloride has been shown to cause cancer in laboratory animals.

The second petition came from the International Association of Color Manufacturers, the industry group for color makers. It sought removal of methylene chloride, ethylene dichloride, and trichloroethylene as approved solvents for producing annatto extract, paprika oleoresin, and turmeric oleoresin. The petitioner demonstrated that industry had already abandoned those uses, the FDA said.

Annatto, paprika, and turmeric are plant-based colors that impart yellow, orange, or red tones to foods such as cheese, snacks, sauces, and seasonings. The FDA did not indicate whether any produce-marking ink manufacturers were still using methylene chloride.

The Solvents and Their Risks

The three solvents are better known for industrial applications. Methylene chloride has been used in paint strippers and degreasers, while trichloroethylene has been used in metal cleaning. The World Health Organization’s cancer agency classifies trichloroethylene as carcinogenic to humans and methylene chloride as probably carcinogenic to humans, according to the Center for Science in the Public Interest.

The Environmental Protection Agency banned most consumer and commercial uses of methylene chloride in 2024. Food uses fall under FDA jurisdiction, which is why the EPA rule did not extend to them, Food Safety Magazine reported.

For the three color additives, the color industry itself informed the FDA it no longer used these solvents, so the primary effect is to close approvals that had remained on the books. The FDA did not estimate how much, if any, consumer exposure the change eliminates.

The decision has been years in the making. The FDA published notice of the advocacy groups’ petitions in January 2024 and reopened public comment in May, according to a Federal Register summary from Policy Risk. Advocates have argued that remaining food uses warrant the same scrutiny.

Decaf Coffee Remains a Separate Question

The November 9 action covers color additives only. Methylene chloride is also approved as a food additive for decaffeinating coffee, with a residue limit of 10 parts per million, and that approval was not part of this decision.

A separate petition from the same advocacy groups asks the FDA to end food additive approvals for methylene chloride, benzene, ethylene dichloride, and trichloroethylene. The FDA reopened public comment on that petition this year, and the comment period closed June 29, Daily Coffee News reported. The agency requested input on practical considerations for phasing out affected uses if it grants the petition in whole or in part.

The coffee industry has opposed that request. The National Coffee Association says about 26 million U.S. adults drink decaf daily and that most decaf is made with the solvent-based European Method. “Banning European Method decaf would defy science and harm Americans’ health,” association president Bill Murray said in March 2024. Advocacy groups counter that the Delaney Clause allows no cancer-causing additives, regardless of amount.

Independent testing by the Clean Label Project in 2020 and 2022 found methylene chloride in several common decaf brands, according to the Environmental Defense Fund. Many people who drink decaf are limiting caffeine for health reasons, such as pregnancy or heart rhythm problems, which is why advocates say the pending decision matters to households. Some coffee companies already use solvent-free methods, such as water or carbon dioxide processing.

Consumer Guidance While Rules Evolve

No action is needed for fresh produce, spices, or packaged foods because of this decision. Shoppers do not need to discard foods colored with annatto, paprika, or turmeric, which remain approved colors. Only certain solvents used to make them were removed.

People who want to avoid methylene chloride in decaf can look for coffee labeled as decaffeinated by the Swiss Water Process, by water, or by carbon dioxide, or ask the roaster which method it uses. Washing fresh fruits and vegetables under running water before eating remains a good habit for removing dirt and surface residues.

Workers who handle solvents face far higher exposure than consumers. Anyone who uses solvents on the job and develops dizziness, headaches, or breathing problems should speak with a clinician and their employer about ventilation and protective equipment.

The color changes take effect January 11, 2027. The FDA has not announced a decision on the food additive petition covering decaf coffee.

Key Questions Answered

What did the FDA revoke? Methylene chloride in produce-marking inks and three solvents used to make annatto, paprika, and turmeric colors.

When does the change take effect? January 11, 2027.

Why did the FDA act? One petition cited the Delaney Clause on cancer-causing color additives. Industry said the other uses had been abandoned.

Is methylene chloride still allowed in decaf coffee? Yes. That separate food additive approval was not part of this decision and remains under review.

Do I need to throw out foods with annatto or paprika color? No. The colors remain approved. Only certain solvents used to make them were removed.

How can I avoid methylene chloride in decaf? Choose coffee decaffeinated with water or carbon dioxide methods, or ask the roaster.

Source link