What Is the Food Contact Notification (FCN) Program?

The Food Contact Notification program is the U.S. Food and Drug Administration’s premarket pathway for authorizing new substances that touch food during manufacturing, packaging, storage, or transport. A manufacturer or supplier files a notification with FDA, and if the agency raises no objection within 120 days, the substance can enter interstate commerce for the uses described in the filing.¹ The program was created by the Food and Drug Administration Modernization Act of 1997 and replaced the slower food additive petition process with a notification system built around that 120-day review clock.²

What the Program Covers

A food contact substance is any material intended for use as a component of packaging, processing equipment, or other materials that touch food. The essential qualifier is that the substance must not be intended to have a technical effect on the food itself.³ Plastic resins in beverage bottles, adhesives in cereal boxes, coatings on conveyor belts in food plants: all classic FCN territory.

The program targets what regulators call indirect additives, substances that might migrate into food in trace amounts through contact rather than ingredients added on purpose. If a substance is designed to alter the taste, color, or texture of the food, it falls outside this program and goes through the traditional food additive petition route instead.

When You Do Not Need an FCN

Not every food contact material requires a notification. Filing one where an exemption applies wastes months and toxicology work you did not need.

GRAS substances. If qualified experts generally recognize a substance as safe for its intended use, either through published scientific evidence or, for substances used before 1958, a substantial history of consumption, it falls outside the food additive definition and needs no FCN.⁴
Prior-sanctioned substances. Materials whose use in food packaging received explicit government approval before the 1958 food additives amendment are exempt.⁵
Threshold of Regulation exemptions. If a food contact substance migrates into food at or below 0.5 parts per billion, equivalent to 1.5 micrograms per person per day, FDA can exempt it from regulation as a food additive, provided the substance is not a carcinogen. A separate path exists for substances already approved for direct addition to food, where dietary exposure from the contact use stays at or below 1 percent of the acceptable daily intake.⁶

Sorting which path applies is one of the first decisions a manufacturer should make.

What Goes Into a Submission

The documentation requirements are substantial. Under 21 CFR 170.101, the notification must include a comprehensive safety discussion addressing all submitted data, including any results that might appear inconsistent with a finding of safety.⁷ The package breaks into three categories.

Chemistry

You identify the substance precisely: chemical structure, manufacturing process, and any impurities in the finished material. Migration data sits at the center. Through laboratory testing or mathematical modeling, you calculate how much of the substance transfers into food under the intended conditions of use. Those calculations drive the estimated daily intake figures FDA uses to assess risk. Weak migration data is where most poor submissions collapse, because it determines whether the exposure level triggers concern.

Toxicology

The biological data must establish that the substance is safe at projected exposure levels. Typical packages include genotoxicity tests and short-term feeding studies, though the specific battery depends on the estimated dietary concentration. FDA’s safety standard under section 409(c)(3)(A) of the FD&C Act requires reasonable certainty of no harm, and the toxicology data is where you prove it.¹

Environmental Review

Every submission must include either an environmental assessment or a claim of categorical exclusion under the National Environmental Policy Act. A categorical exclusion claim requires a statement that the submission meets the exclusion criteria and that no extraordinary circumstances exist. An inadequate environmental review is on its own sufficient grounds for FDA to refuse to accept the notification.⁸

All of this information gets entered into FDA Form 3480 and submitted to the Office of Food Additive Safety through FDA’s Electronic Submissions Gateway or by mail.⁹ An FCN may incorporate by reference any information already in FDA’s files, but only if the notifier has authorization to reference that data.¹⁰

Talk to FDA Before You File

FDA encourages manufacturers to request a pre-notification consultation, and in some situations the step is practically essential. The agency specifically recommends consulting when data interpretation could change the safety outcome, for example when the estimated daily intake is close enough to the acceptable daily intake that different assumptions about the no-effect level could flip the conclusion. Consultations are also recommended when different readings of bioassay data could change whether the substance requires an FCN or a full food additive petition.¹¹ These meetings can save a company from spending months assembling the wrong type of submission.

How the 120-Day Review Works

What happens after filing depends on whether the submission is complete. If the FCN contains everything required under 21 CFR 170.101, the 120-day clock starts on the date FDA receives it, and the agency sends a written acknowledgment. If any required element is missing, FDA will not accept the notification and issues a nonacceptance letter. When a notifier supplies the missing information before the nonacceptance letter goes out, the 120-day period starts from the date that supplemental information arrives.¹²

If 120 days pass without an objection, the notification becomes effective and the substance can be introduced into interstate commerce for the specified uses.¹ FDA keeps the contents of the notification confidential during the review period. After 120 days, the information becomes available to the public, except for trade secrets and confidential commercial information.

Objections and Withdrawal

If FDA determines during the review that the proposed use has not been shown safe, it issues an objection letter and the notification does not become effective.¹² That objection is final agency action, so the manufacturer can challenge it in federal court through judicial review.¹ FDA may also object if any part of the review period falls during a time when the program lacks congressional funding.

For less severe problems, where the submission is accepted but the agency identifies gaps during review, FDA gives the notifier a brief window to supply the missing information or withdraw. The agency does not specify a fixed number of days. If the information is not provided and the FCN is not withdrawn, FDA issues a nonacceptance letter to close the review.¹¹

A manufacturer can voluntarily withdraw a notification without prejudice at any time before FDA completes its review, meaning before the agency issues an objection letter or allows the 120 days to expire. Withdrawing preserves the right to submit a new, improved notification later.¹³ If both FDA and the notifier agree that a full food additive petition is more appropriate, the FCN is treated as withdrawn on the date the petition is received.¹²

What an Effective FCN Gets You

An effective FCN carries a legal feature that catches many in the industry off guard: it is proprietary. The notification applies only to the specific manufacturer or supplier named in the filing. A competitor cannot rely on another company’s effective FCN to market the same substance, even if the chemical composition is identical. Each manufacturer must secure its own authorization.¹⁴ Anyone who purchases the substance from a manufacturer named in an effective FCN can, however, use it for the purposes described in that notification.

FDA maintains a searchable public inventory of all effective FCNs. Each entry lists the substance, the notifier, the manufacturer, the intended use, any limitations on conditions of use, the specifications, the effective date, and the environmental decision.¹⁴ If your substance and manufacturer are not on it, you do not have authorization under this program.

When You Need a New FCN

An effective FCN is not a blanket approval. It covers a specific substance, made by a specific manufacturer, for specific uses. Change any of those variables, and you likely need a new filing. FDA’s guidance identifies four triggers:

A different manufacturer wants to make the same substance.
Substantive changes to the chemical specifications.
Manufacturing process changes that substantively alter the identity of the product, its impurities, or impurity levels.
New conditions or levels of use beyond what the original FCN described.

The word “substantive” does the heavy lifting. Deviations that fall within normal good manufacturing practice are not considered substantive, and FDA evaluates other deviations case by case.¹¹ There is no procedure to amend an effective FCN. You file a new one.

Consequences of Skipping the Program

Marketing a food contact substance without a valid FCN or other authorization means the food it touches can be deemed adulterated under 21 USC 342(a)(2)(C), because it bears or contains an unsafe food additive.¹⁵ That classification opens the door to enforcement. FDA can seek court-ordered injunctions to halt distribution under 21 USC 332.¹⁶ Most enforcement begins with warning letters, but intentional or repeated violations can escalate to seizure of goods or criminal prosecution.

FDA can also determine that a previously effective FCN is no longer effective, for instance when a manufacturer has ceased production of the substance. Monitor the inventory and the Federal Register for notices affecting your authorizations. Once an FCN loses its effective status, any food contact use relying on it loses its legal footing.

1
Office of the Law Revision Counsel. 21 USC 348 – Food Additives
2
U.S. Food and Drug Administration. Regulatory Background of the Food Contact Substance Notification Program
3
Food and Drug Administration. Guidance for Industry – Preparation of Food Contact Substance Notifications (Administrative)
4
U.S. Food and Drug Administration. Generally Recognized as Safe (GRAS)
5
eCFR. 21 CFR Part 181 – Prior-Sanctioned Food Ingredients
6
eCFR. 21 CFR 170.39 – Threshold of Regulation for Substances Used in Food-Contact Articles
7
eCFR. 21 CFR 170.101 – Information in a Premarket Notification for a Food Contact Substance (FCN)
8
eCFR. 21 CFR Part 25 – Environmental Impact Considerations
9
U.S. Food and Drug Administration. How to Submit a Food Contact Substance Notification
10
eCFR. 21 CFR 170.100 – Food Contact Substance Notification
11
U.S. Food and Drug Administration. Guidance for Industry – Preparation of Food Contact Substance Notifications (Administrative)
12
eCFR. 21 CFR 170.104 – Action on a Premarket Notification for a Food Contact Substance
13
eCFR. 21 CFR 170.103 – Withdrawal Without Prejudice of a Premarket Notification for a Food Contact Substance
14
U.S. Food and Drug Administration. Inventory of Effective Food Contact Substance (FCS) Notifications
15
Office of the Law Revision Counsel. 21 USC 342 – Adulterated Food
16
Office of the Law Revision Counsel. 21 USC 332 – Injunction Proceedings