US: update on food contact materials

A food contact material (FCM) is any chemical, substance or material that is in contact with food but is not intended to be added directly to the food (also known as indirect food additives).

One example of how FCMs are regulated in the US is the market phase-out of per- and polyfluoroalkyl substances (PFAS) for grease-proofing of paper and paperboard packaging as required by the Food and Drug Administration (FDA).

On 6 January 2025, the FDA announced that food contact notifications (FCNs) for 35 PFAS are no longer effective.

The FDA revoked the authorisations for these specific FCNs following agency confirmation that the manufacturers had ceased production, supply, sale and/or use of these materials for this purpose.

Although the current reorganisation of the FDA may impact activities, the following changes are expected to take place for FCMS:

Elimination of GRAS for FCMs

In March 2025, the Health and Human Services secretary, Robert F Kennedy Jr., instructed the FDA to make changes to the Generally Recognized As Safe (GRAS) program that would prevent manufacturers from using the GRAS option for new food contact substances (FCSs) or additives without pre-market agency review. Different options are currently being explored for this program.

Regulation at state level

A review of state legislative agendas for 2025 indicates that policies for regulation of plastics and packaging are likely to be enacted in at least 17 states and the District of Columbia.

The policies include elimination of harmful plastics and additives, requiring reuse, restricting chemical reuse and restricting the use of intentionally added microplastics.

These initiatives are in line with both global and corporate interests that intend to eliminate harmful plastic additives, such as phthalates and bisphenols, from their products and packaging.

The California Proposition 65 (Prop 65) legislation also targets FCMs that are listed as either carcinogens or reproductive toxicants.

In the past, this listing has led to changes in labelling and reformulation of final products to remove the identified substance. Substances are continuously added to the list so it is likely that future impacts will occur.

Landbell Group company, H2 Compliance provides FCM information and support. Find out more here.