What are Food Contact Materials (FCMs)?
A Food Contact Material (FCM) is any chemical, substance or material contacts with food but is not intended to be added directly to the food (also known as indirect food additives). The contact with food may occur via numerous processes such as packaging, holding, or processing of the food as well as via kitchen equipment and utensils.
While the safety is of paramount importance, the use of packaging and holding materials has several advantages for the food supply chain such as increased shelf life and sterility. At the same time, these chemicals may potentially move from the packaging into the food and cause a safety risk, leading to regulatory evaluations for any proposed or existing food contact materials. Due to these regulatory concerns, suppliers and manufacturers must consider the safety of the substances used in the packaging materials in addition to the use of these materials are designed to attract consumers.
How are FCMs regulated?
The use of FCMs is highly regulated and must be authorized for use per the appropriate country regulations (e.g. EU, UK, USA, Canada, Australia, MERCOSUR, China, Japan, Switzerland etc.). These regulations ensure that any substance that may become a FCM such as plastic, paper, paperboard, printing ink, ceramic, wood, metal, cork, textiles, and adhesives are materials approved as safe for the intended food contact application. To obtain authorization or approval, the FCM must be fully evaluated for safety based on regulatory requirements specific for the intended country or region of sale. Once completed, the food contact notification (FCN) or evaluation must be submitted to the relevant authorities for approval of use as an FCM. If no regulation currently exists for a proposed FCM in a given country, then evaluation and authorization is likely needed prior to use of this substance as a new FCM.
One example of how FCMs are regulated in the U.S. is the market phase-out of per- and polyfluoroalkyl substances (PFAS) for grease-proofing of paper and paperboard packaging as required by the U.S. Food and Drug Administration (FDA). On January 6, 2025, the FDA announced that FCNs for 35 PFAS are no longer effective. These FCNs had been for authorized FCMs used as grease-proofing coatings of paper and paperboard packaging to prevent leaking of oil and water. The authorizations for these specific FCNs were revoked by the FDA following agency confirmation that the manufacturers had ceased production, supply, sale and/or use of these materials for this purpose.
What changes to FCM approval may be in the future in the U.S.
- Reorganization at the FDA
The FDA is currently being reorganized by the HHS with approximately 3500 employees (20% of the agency workforce) being laid off along with the elimination of entire departments. As per the HHS, these actions are meant to streamline operations by centralizing administrative functions designed to make the FDA operate mor efficiently. The reductions are not intended to have any effect on the FDA’s ability to conduct food, drug or medical device reviews or inspections. However, numerous reports from both inside and outside the agency have stated that reductions in staff may negatively impact the FDA’s ability to perform its functions. It is not clear at this time what impacts, if any, will occur in this regard. Regardless of these actions, it should be noted that the FCN program is mandated by legislation so elimination of this program would only occur if Congress did not fund it.
- Elimination of GRAS for FCMs
A substantial change would be the elimination of the Generally Recognized As Safe (GRAS) rule for FCMs in the U.S. In March 2025, the Health and Human Services (HHS) secretary, Robert F Kennedy Jr., instructed FDA to make changes to the GRAS program that would prevent manufacturers from using the GRAS option for new food contact substances (FCSs) or additives without pre-market agency review. At the same time, it was proposed that, instead of total elimination, all GRAS determinations should be completely public and open to independent verification and analysis. As part of the revised requirements, the manufacturer of a new or existing ingredient would have to publicly submit safety data for the ingredient. Another proposal is that the FDA should develop a tiered system in which those substance with a documented long history of safe use would have reduced requirements as opposed to those that are either new and not fully characterized or those with records of problematic effects. These different options are currently being explored without any definitive requirement proposed as of yet.
- Regulation at the state level
A review of the 2025 state legislative agendas indicates that consideration of 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 alignment with both global and corporate interests that intend to eliminate harmful plastic additives (i.e., phthalates and bisphenols) from their products and packaging.
The California Proposition 65 (Prop 65) legislation is another concern for FCMs that are listed as either carcinogens or reproductive toxicants. In the past, this listing has led to changes in labeling 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.
This brief overview shows how the FCM landscape can change rapidly with little warning.
One question that every packaging company needs to ask is:
H2 Compliance can help you with your FCM needs!
We have the expertise in the following services that can aid with your FCM approvals:
- Evaluation of safety profile and regulatory compliance for individual FCMs and final formulations
- Prepare and submit required regulatory notifications to relevant authorities, (FDA, EFSA, CFSA, etc.) that include the following:
- Perform risk assessments to characterize safe use for FCMs
- Coordinate required testing for compliance and notifications including customized analysis and migration testing
- Author the documents required for FCM approval as per the relevant regulations
Published November 18th, 2025
This article image was generated with the assistance of Artificial Intelligence.