We, members of the Food Packaging Forum (FPF), submitted comments to the U.S. Food and Drug Administration’s (FDA) public consultation on the development of an enhanced systematic process for the post-market assessment of chemicals in food (FPF reported). The commenting period closed on January 21, 2025.
Safety assessment
In our comments, we emphasize the importance of using modern scientific knowledge and principles for safety assessments of chemicals. This includes recognizing low-dose effects and non-monotonic dose responses (FPF reported and here), considering the impact on vulnerable population groups, and accounting for the complexity of chemical exposures, such as mixtures and cumulative effects (FPF reported). Moreover, the many chemicals migrating from food contact materials that have not been tested for hazardous properties should not be considered safe but require proper testing.
Testing
We highlight the need for toxicity testing to extend beyond assessing genotoxicity to include multiple endpoints, including those relevant for how chemicals contribute to (or cause) cardiovascular diseases, brain-related disorders, metabolic and endocrine diseases, immunological and reproductive disorders, and non-genotoxic cancers. Defining a set of relevant and robust in vitro assays allows screening for functional effects associated with chronic diseases in a standardized approach (FPF reported). Additionally, hazard assessments should consider the persistence and bioaccumulation potential of the chemicals.
To enhance efficiency, we recommend assessing groups of chemicals with similar structures rather than evaluating the thousands of individual chemicals (FPF reported). By adopting a hazard-based approach to food contact chemical management, time and resources required for post-market assessments can be reduced further while consumer protection is improved (FPF reported).
Scientific resources
Proactive and periodic reassessments, rather than reactive measures, are needed to ensure that regulatory assessments remain aligned with evolving scientific knowledge. Action should be taken when there is uncertainty about safety rather than waiting for definitive proof of harm. Given the substantial number of chemicals of concern in food and food packaging and the significant data gaps associated with many known food contact chemicals, we underscore the importance of prioritizing chemicals based on existing data sources. These include the PlastChem report (FPF reported), the database on migrating and extractable food contact chemicals (FCCmigex), the database on food contact chemicals monitored in humans (FCChumon), and our 2022 study on implementing the EU Chemicals Strategy for Sustainability for food contact chemicals of concern.
Transparency
Drawing on the experience of other regulatory bodies, we recommend establishing a clear separation between risk assessment and risk management. Early and ongoing engagement with all stakeholders throughout the post-market assessment process may enhance transparency. This involvement should begin with the development of protocols, processes, and criteria and extend to the peer-review of risk assessments.
We urge the FDA to ensure that individuals responsible for pre-market approvals are not involved in reassessments to prevent potential biases. In addition, we suggest that the FDA establishes systematic and transparent procedures, taking inspiration from the existing frameworks of the U.S. Environmental Protection Agency (EPA) and the European Food Safety Authority (EFSA).
References
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 (January 21, 2025) “Comment on Food Additive Petition FDA-2024-N-3609.”
