In a press release on May 12, 2026, the US Food & Drug Administration (FDA) shared its finalized systematic process for the post-market assessment of chemicals in food. The new process aims to fill current gaps in FDA assessments for food chemicals already on the market, including food additives, color additives, generally recognized as safe (GRAS) substances, food contact substances, and chemicals that are present as contaminants (FPF reported).
“Today’s release finalizes our framework for this new, dedicated reassessment program that provides Americans with confidence that the FDA is ensuring chemicals in the U.S. food supply remain safe as new scientific information becomes available,” said Kyle Diamantas, former Deputy Commissioner for Food and newly appointed acting FDA commissioner.
Identifying chemicals in food
In the first part of the post-market assessment process, an AI-based platform, as well as other traditional channels, will be used to monitor the scientific literature and media for signals suggesting potential evidence for hazardous food chemicals. Once such a signal is identified, a triage process will be conducted to determine whether the new post-market process is the best assessment pathway for the chemical. Chemicals that pose an immediate health risk, as well as those with cancer evidence or that are being regulated by other food safety authorities, will be put through other, existing FDA channels.
Prioritizing food chemicals for scientific assessment
Alongside the systematic process, the FDA also published its Tool for the Prioritization of Food Chemicals for Post-Market Assessment, which will be used to prioritize triaged food chemicals for review in the next phase of the post-market assessment process. The tool focuses on potential risk to public health and scores chemicals based on the known health effects, exposure risk to general and susceptible populations, and presence of newly available data.
The Food Packaging Forum (FPF) submitted comments on a draft of this tool in 2025, recommending that additional health hazards be considered, such as endocrine disruption (FPF reported). A grouping approach was also put forward to simplify the prioritization approach and ensure robustness long-term. While these recommendations were not incorporated in the final tool, the FDA says that it made other changes based on public comments, including “streamlining decisional criteria and scoring to focus on public health outcomes and increasing clarity on how the prioritization tool fits into the FDA’s overall systematic process.”
Conducting scientific assessments and managing risks
In the second phase of the systematic process, the FDA will announce a post-market work plan each year with the priority list of chemicals selected for scientific assessment. Based on public feedback, opportunities to submit data and to comment on the scientific assessment have been interwoven into the process. The status of chemical reviews can be monitored through the List of Select Chemicals in the Food Supply Under FDA Review.
Upon completion of the scientific review, the FDA will determine if any action needs to be taken to manage risks within the food supply chain. Such action could include revoking or amending authorizations for specific uses, market phase-outs, recalls, or specifying limits.
Reassessing the safety of BHT and ADA
In addition to announcing the new post-market assessment program, the FDA also launched the reassessment of two food additives: butylated hydroxytoluene (BHT, CAS 128-37-0) and azodicarbonamide (ADA, CAS 123-77-3), including a request for data about the use and safety of these chemicals in food. The full requests for information are available on the Federal Register for BHT and for ADA.
Criticism from the Environmental Defense Fund
In a press release on May 15, 2026, the Environmental Defense Fund (EDF) shared their disappointment that many of their comments on the draft assessment program were also not adopted and highlighted remaining gaps. Based on EDF’s assessment, the FDA’s new program will continue to allow previously approved cancer-causing chemicals to be treated as safe, despite existing laws that explicitly ban carcinogens in food (FPF reported). Under the new post-market assessment program, chemicals with insufficient evidence of harm would also not be assessed. According to EDF, many chemicals will fall into this category because they have not been sufficiently studied, not because they are low risk. Finally, the approach of looking at individual chemicals does not consider the potential caused by cumulative toxicity of similar chemicals, says EDF.
References
U.S. Food & Drug Administration (May 12, 2026). “FDA Finalizes Food Chemical Safety Post-Market Assessment Program, Launches Reassessment of BHT, ADA.”
U.S. Food & Drug Administration (May 12, 2026). “The Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food.”
U.S. Food & Drug Administration (May 12, 2026). “Tool for the Prioritization of Food Chemicals for Post-Market Assessment.”
Environmental Defense Fund (May 15, 2026). “FDA’s new post-market food chemical safety program a step forward, but gaps leave Americans at risk.”
Read more
Kelly Franklin (May 13, 2026). “US FDA finalises framework for post-market food chemical safety reviews.” Chemical Watch News & Insight.
