FDA Food Contact Substance Notification: What Foreign Packaging Manufacturers Must Know

Every material that comes into contact with food in the United States — packaging films, coatings, adhesives, gaskets, containers, and processing equipment surfaces — is regulated by the FDA as a food contact substance under the Federal Food, Drug, and Cosmetic Act. Foreign packaging manufacturers who supply materials to US food producers or who export pre-packaged food to the American market must understand that their packaging is not just a container — it is a regulated component of the food product itself. The FDA treats any substance that migrates from packaging into food as a food additive, and food additives require premarket authorization before they can be legally used.

What is a food contact substance under FDA regulation

A food contact substance (FCS) is defined under Section 409(h)(6) of the FD&C Act as any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food, if the substance is not intended to have any technical effect in the food itself. This includes polymers used in plastic packaging, printing inks on food labels, adhesives in laminated pouches, coatings on metal cans, rubber gaskets in processing equipment, and paper or paperboard used in food packaging. The definition is broad — it covers not only the primary packaging that directly touches the food but also secondary materials whose components might reasonably be expected to migrate into the food.

The regulatory framework for food contact substances is found in 21 CFR Parts 170 through 199. Part 174 covers indirect food additives used in adhesives and components of coatings. Part 175 covers adhesives and coatings themselves. Part 176 covers paper and paperboard components. Part 177 covers polymers. Part 178 covers adjuvants and production aids. If a substance is already listed in these regulations for the intended use and conditions, no additional authorization is needed. But if a manufacturer wants to use a new substance — or use an existing substance under different conditions of use — a Food Contact Notification (FCN) must be filed with the FDA.

The Food Contact Notification process

The Food Contact Notification program, established under Section 409(h) of the FD&C Act, allows manufacturers to notify the FDA of a new food contact substance at least 120 days before marketing. The FCN must include the identity and chemical composition of the substance, the intended conditions of use (temperature, food type, duration of contact), migration data demonstrating how much of the substance transfers into food under those conditions, and a safety assessment showing that the estimated dietary exposure is safe. The FDA reviews the notification and either allows it to become effective after 120 days or objects if the data are insufficient.

Unlike a food additive petition, which results in a regulation that any manufacturer can rely on, an FCN is specific to the notifier and the manufacturer identified in the notification. This means that a competitor cannot rely on another company's FCN — each manufacturer must file their own notification for their own substance. The FCN also becomes ineffective if the FDA later determines that the substance is unsafe, if the notification contains a material error, or if the notifier fails to comply with conditions specified in the FCN. As of 2026, there are over 2,200 effective FCNs listed in the FDA's inventory.

GRAS exemption and threshold of regulation

Some food contact substances may qualify for Generally Recognized as Safe (GRAS) status under 21 CFR 170.30, which exempts them from the food additive petition and FCN requirements. For a substance to qualify as GRAS for food contact use, there must be publicly available scientific evidence establishing safety, and qualified experts must generally agree that the substance is safe under the intended conditions of use. Manufacturers may self-determine GRAS status, but FDA encourages voluntary GRAS notifications under 21 CFR Part 170, Subpart E, so the agency can evaluate the basis for the determination.

Additionally, the FDA established a Threshold of Regulation (TOR) exemption under 21 CFR 170.39 for food contact substances that migrate into food at levels below 0.5 parts per billion. If a manufacturer can demonstrate through migration studies that a substance transfers into food at concentrations below this threshold — and the substance is not a known carcinogen — the FDA may grant a TOR exemption, eliminating the need for an FCN or food additive petition. TOR requests are submitted to the Office of Food Additive Safety and are typically reviewed within 60 days.

Common compliance gaps for foreign packaging manufacturers

Foreign packaging manufacturers frequently encounter compliance problems when their materials were developed and tested under EU or Asian regulatory frameworks that do not align with FDA requirements. The European Union regulates food contact materials under Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011 for plastic materials, which use a positive list of authorized monomers and additives with specific migration limits. While there is some overlap between EU and US authorized substances, the lists are not identical — a polymer authorized in the EU may not have a corresponding FDA listing or effective FCN. Migration testing protocols also differ — the EU uses specific food simulants (10% ethanol, 3% acetic acid, olive oil) while the FDA has its own set of food-simulating solvents under 21 CFR 176.170.

Another common gap involves recycled materials. The FDA's guidance on recycled plastics in food packaging requires manufacturers to demonstrate that the recycling process adequately removes contaminants that might be present in post-consumer material. This typically involves submitting a request for a No Objection Letter from FDA's Division of Food Contact Notifications, supported by challenge testing data showing that the recycling process reduces contaminant levels to safe thresholds. Foreign recyclers who have not gone through this process cannot supply recycled packaging material for food contact use in the US market.

How FDABridge helps foreign packaging manufacturers

FDABridge assists foreign packaging manufacturers in understanding their FDA obligations and navigating the food contact substance regulatory framework. Whether you need guidance on whether your materials require an FCN, help determining if existing regulations already cover your intended use, or assistance preparing a Threshold of Regulation request, our regulatory team can evaluate your materials and advise on the most efficient path to compliance. Visit fdabridge.com/food to learn about our food compliance services or fdabridge.com/contact to speak with our team.