The US Food and Drug Administration (FDA) has reopened public comment periods on two petitions seeking to remove regulatory authorisations for the use of four solvents in food processing and colour additive applications.
The move marks new action on petitions that have languished for more than two years, amid a push from the FDA to expand post-market review of food chemicals and remove potentially harmful additives from the US food supply.
The petitions, filed in late 2023 by the Environmental Defense Fund (EDF), the Environmental Working Group (EWG) and other public health advocates, target specific uses of four carcinogenic solvents in food applications: benzene, ethylene dichloride, methylene chloride and trichloroethylene (TCE).
Initially released for public consultation in January 2024, the petitions argue that all four chemicals are prohibited under the Delaney Clause of the Federal Food, Drug, and Cosmetic (FD&C) Act. This provision bars the FDA from approving food or colour additives found to induce cancer in humans or animals.
The food additive petition seeks to remove authorisation for all four solvents in applications such as decaffeination of coffee, extraction of resins from hops and spices, washing of sugar beets and dilution of pesticides.
Meanwhile, the colour additive petition addresses three of the four same substances, excluding benzene. According to the petition, the solvents are used to extract resins from spices such as annatto, paprika and turmeric to make colour additives, and to dilute inks for marking fruits and vegetables.
The FDA said on 27 May it is reopening both dockets for 30 days to allow submission of updated data and information developed over the past two years. The agency also called for input on how a phase-out might affect industry, asking for comments on the "practical considerations food manufacturers would have in phasing out impacted uses if FDA were to grant [the petitions] in part or in whole".
Comments on both petitions are due on 29 June.
FDA urged to act
The agency’s action closely follows its publication of a separate petition from an industry group, the International Association of Color Manufacturers (IACM), seeking to revoke colour additive approvals for ethylene dichloride, methylene chloride and TCE for the same uses named in the NGO petition.
According to the IACM petition, published for public comment on 1 April, industry has already permanently abandoned these uses.
Maria Doa, senior director for chemicals policy at EDF, said the agency already has sufficient information and authority to act on the requests.
"It's against the law for FDA to continue to approve these cancer-causing substances and there are known safer alternatives available on the market," she said.
"FDA prolonging their response to this petition filed over two years ago only puts us at more risk for reproductive harm, cancer and chronic disease."
Separate TSCA developments
The US EPA is taking its own actions to address the risks posed by industrial uses of all four substances under TSCA.
The agency adopted final TSCA risk management rules for methylene chloride and TCE in 2024, prohibiting most industrial uses of the two chlorinated solvents.
More recently, the EPA finalised a risk evaluation for ethylene dichloride, also known as 1,2-dichloroethane or 1,2-DCA, which identified unreasonable risk in 15 of the 20 conditions of use (COUs) assessed by the agency. The EPA will now need to develop a risk management rule to address those concerns.
Benzene, the fourth chemical in the food additive petition, entered the TSCA prioritisation process in December 2024, although a high-priority designation has not yet been adopted.
TSCA's jurisdiction does not extend to food-related uses, which fall exclusively under the FDA's authority.