The U.S. Food and Drug Administration (FDA) has finalized its new systematic approach to post-market safety assessments for food chemicals.

The agency has also launched reassessments of two common food additives, butylated hydroxytoluene (BHT) and azodicarbonamide (ADA).

For post-market chemical assessments, FDA will monitor and triage signals that provide information on hazards, use, or exposure related to food chemicals, then prioritize, assess, and manage these chemicals in the food supply. The agency first outlined its draft post-market review process in September 2024. Since then, several key changes have been made to the finalized process, specifically:

• Additional public engagement opportunities were included throughout the process, such as requesting information from the public prior to conducting most scientific assessments, making preliminary scientific assessments available for public comment, and plans to include public nomination of candidate food chemicals for post-market assessment
• The option to peer review preliminary scientific assessments has been included
• The division between “focused” and “comprehensive” assessments has been removed; FDA will now use a single type of post-market assessment, and the scale of each assessment will depend on the state of the available science for that chemical, as well as its uses or presence in food or food contact materials
• Additional details have been provided regarding how FDA will receive and identify potential safety concerns during signal detection, triage signals to determine how they should be handled, and prioritize food chemicals for scientific assessments.

The finalized post-market review process is three-part:

1. Food chemical signal monitoring: Identifying potential chemical hazards, new uses of chemicals, substantial changes that increase the likelihood of adulteration, and significant changes in dietary exposure or safety information. FDA will use an artificial intelligence (AI) platform, the Warp Intelligent Learning EnginE (WILEE), to process large volumes of publicly available data (from databases and academic literature, international food safety organizations, trade groups, the press, and the web to identify these chemical safety signals.
2. Triage: After signals are identified, FDA will determine if a systematic safety review is the appropriate pathway or if it should be handled through an alternative process, and the chemical will be prioritized using a prioritization tool that considers specific criteria. There are two instances where chemicals will receive immediate assessment: when there is cancer evidence for approved additives, and when safety assessments conducted by other regulatory agencies provide evidence of adverse effects.
3. Scientific assessment: FDA will use a case-by-case approach to assessment of each chemical, which will involve initial stakeholder engagement, a preliminary scientific assessment, additional stakeholder engagement, and the finalization and publication of a final assessment. FDA’s standards for evaluating data quality during post-market scientific assessments will be no different from those that are used by FDA for pre-market assessments or for any other scientific assessment.

Once the scientific assessment is complete, FDA will determine if any action needs to be taken to ensure the safety of the food supply, which can include revoking or amending authorizations for substances, working with industry on voluntary phase-outs, developing action levels, issuing alerts, blocking imports, and other actions.

Each year, FDA intends to establish and publish an annual work plan, which will list food chemicals slated for assessment and will be regularly updated.

The full outline of the finalized systematic post-market food chemical review process can be read here.