Food Additive Petition seeking amended food additive regulations to remove FDA's approval of four carcinogenic solvents

The Consumer Brands Association opposes the petition to remove methylene chloride as a food additive, arguing that the petition relies on a hazard-based approach rather than a risk-based one that accounts for negligible real-world exposure. They highlight that more than half of the decaffeinated coffee market relies on this method and warn of significant supply gaps and economic burdens if the solvent is revoked.

The Environmental Defense Fund (EDF) supports the FDA's proposal to ban methylene chloride as a food additive, arguing that commercially viable alternatives already exist. They contend that the U.S. market's scale makes the transition feasible and that the FDA's cost-benefit analysis should include the monetized public health benefits of removing this carcinogen.

The American Beverage Association opposes the removal of methylene chloride from the FDA's approved food additive list, arguing that scientific evidence supports its safe use in decaffeinating coffee and that revoking its authorization would cause significant economic harm. They highlight that residues pose negligible risk and request that if the FDA proceeds with a revocation, it must provide the industry with adequate time and enforcement discretion to transition to alternative methods.

Jaydee Hanson, Policy Director, argues that the FDA has delayed too long in banning three carcinogenic solvents (ethylene dichloride, methylene chloride, and trichloroethylene) from food use. The commenter urges the FDA to promptly ban these chemicals in accordance with the Delany Act.

The International Food Additives Council (IFAC), a global trade association, opposes the broad removal of authorized solvents, arguing that the FDA should instead use a use-specific approach based on actual consumer exposure and manufacturing conditions. They emphasize that many current uses involve purification steps that minimize residues and warn that removing authorizations could lead to significant supply chain disruptions, increased costs, and technical feasibility issues.

The commenter argues that the use of methylene chloride in decaffeination is a safe, well-established industrial process with sufficient safety margins provided by roasting and brewing. They advocate for maintaining current FDA limits based on empirical science rather than speculative concerns or perceptions.

The National Alliance for Hispanic Health strongly supports the proposed rules to remove carcinogenic solvents from food and color additive regulations to protect public health. They urge the FDA to implement these changes quickly, provide clear consumer communication, and establish a fast-tracked timeline for industry compliance.

A professional with a background in chemistry and toxicology argues that the methylene chloride decaffeination process is safe for consumers. They contend that the solvent is highly volatile and effectively recovered, leaving negligible levels in the final product, and therefore the proposed removal of the approval is unnecessary.

Dr. Nadia argues that methylene chloride is safe for use in decaffeinated coffee because the solvent evaporates during roasting and brewing, leaving residues well below safety limits. She cites toxicological principles and epidemiological data to support the claim that current consumption levels pose no significant cancer risk.

The commenters, representing several companies in the decaffeinated coffee and hop extraction industries, oppose the petition to remove authorizations for four carcinogenic solvents. They argue that the petition relies on obsolete regulatory listings rather than current commercial use and fails to distinguish between processing aids and ingredients, potentially causing consumer confusion and economic disruption.