The Food Packaging Forum (FPF) submitted comments to the U.S. Food and Drug Administration’s (FDA) public consultation on the development of a tool for the prioritization of food chemicals for post-market assessment (FPF reported). In this consultation which closed on August 18,2025, the FDA requested feedback on their tool for prioritizing food chemicals for post-market assessment.
The prioritization tool ranks food chemicals—including food additives, color additives, GRAS (notified and non-notified), food contact chemicals, and contaminants—for review using criteria divided into “public health” and “other decisional” factors. The four proposed public health factors were: toxicity, exposure, susceptible subpopulations, and new science. The three other decisional factors were: external attention (e.g., from the media or congress), actions by other federal authorities, and the potential to bolster public confidence. FPF’s comments focused on the public health component of the prioritization tool.
The following is a shortened version of FPF’s comments. The full version is available under docket FDA-2025-N-1733-0001 and contains further links to supporting scientific studies and resources.
Toxicity assessment
While FDA plans to utilize the Global Harmonized System (GHS) of classification for some health hazards included in its toxicity assessment (e.g., carcinogenicity), it does not plan to use it for others (e.g., reproductive toxicity). GHS is internationally recognized and adopting it would simplify FDA’s work, save costs, and foster alignment with other nations.
Endocrine disruption is currently not included in the FDA’s toxicity criterion, although endocrine disrupting chemicals (EDCs) can cause severe health effects even at low exposure levels and are widely prevalent in food contact materials (FCMs; FPF reported). The EU already regulates EDCs, and we encourage the FDA to follow the EU’s example by including endocrine disruption in the post-assessment toxicity criterion (FPF reported).
Additionally, there is no clear process or cut-off for when a chemical has sufficient hazard information to be considered for post-market assessment. Currently, it appears that every chemical must have completed the entire hazard data review. However, being rated high in the toxicity rubric in any of the hazard properties (e.g., carcinogenicity) should automatically trigger a chemical for post market assessment.
Simplicity: group chemicals, remove exposure
The recently developed food contact chemical priority (FCCprio) List systematically identifies and prioritizes known food contact substances based on GHS hazard properties and using publicly available governmental harmonized hazard evaluations (FPF reported). It subsequently ranks them based on their exposure potential. We propose the FDA use this list or this approach as a starting point for prioritizing chemicals for post-market assessment.
The assessment framework currently weighs hazard, exposure, and public interest criteria equally. We recommend the FDA to apply a hazard-based approach which simplifies FDA’s work and makes the assessment process more reliable and reproducible in the long term. Reasons include that for some chemicals no safe levels exist, exposure data are missing for many chemicals, and even if a chemical has data available new scientific findings might demonstrate health outcomes at lower levels which would require another assessment by FDA.
Other
We are unclear on how often independent, peer-reviewed scientific literature will be included in assessments and under what conditions the information would be considered “impactful” enough to cause a substance to be reassessed by the FDA.
Reference
U.S. FDA (August 12, 2024) “Development of an enhanced systematic process for the Food and Drug Administration’s post-market assessment of chemicals in food.”
Food Packaging Forum (August 18, 2025) “Comment on Tool for the Prioritization of Food Chemicals for Post-Market ”
