Food contact notification and FDA supplier checks explained
An FDA food contact notification covers a named source and use. Learn how to check an FCN number, supplier identity, use limits and current effectiveness.
A food contact notification (FCN) is FDA's premarket notification route for a food contact substance and its intended use. An effective FCN covers the identified manufacturer or supplier, not every company selling the same chemical. Purchasers can rely on it for material from that source, within the notification's specifications and limitations. FDA explains these limits in its effective FCN inventory.
For a packaging buyer or compliance team, an FCN number is the start of a check. The record must match both the supplied substance and its proposed use. A matching chemical name alone does not establish coverage.
What a food contact notification covers
A food contact substance is intended as a component of materials used to manufacture, pack, package, transport or hold food. Its use is not intended to have a technical effect in the food. The notification must provide enough scientific information to demonstrate safety for the intended use. FDA describes FCNs as the primary mechanism for regulating food additives that are food contact substances. FDA's administrative guidance explains the program.
FDA describes a mandated 120-day review period. If FDA expresses no safety objections during that period, the company may market the substance for the notified use. This is a no-objection mechanism, not a promise that every application receives approval after 120 days. FDA describes the review process here.
An FCN number identifies a particular notification. It is not a universal approval for the chemical or a certificate for a finished packaging article. FDA says a food contact material's regulatory status depends on its individual constituent substances. Each component needs an applicable regulatory basis.
How to search the FDA FCN list
Start with FDA's inventory of effective food contact substance notifications. Follow its search link to the live FCN database.
Enter a substance or term in Search, then select Show Items. Open the relevant FCN number to read the record. The inventory provides substance, notifier or manufacturer, and effective-date information. The linked record gives the intended use, limitations, specifications and environmental decisions. Column headings let you sort results, and an Excel download is available in the FDA inventory.
Search results can be awkward. FDA's database uses substring matching, so a hit may reflect text elsewhere in the full record. Its example is that searching for "red" can also find "reduce", "ingredient" and "manufactured". Surrounding a word with spaces can narrow the search. A result is therefore a lead to inspect, not proof of an exact substance match. These search instructions appear in the FDA database.
Read the full record. Compare the substance identity, named manufacturer or supplier, intended use, specifications, limitations and effective date. Don't stop at the FCN number on a supplier document. FDA makes the notification's scope source-specific.
Who can rely on an FCN?
A purchaser can rely on an effective FCN for a substance manufactured or supplied by the company identified in it. The use must meet the notification's terms. Anyone marketing a substance on this basis must be able to demonstrate that the notification covers it. FDA states this restriction expressly.
A downstream reseller does not lose that basis merely because it is not the named manufacturer. But the material must come from the covered source, and its identity and use must still match. FDA says users must be able to trace the substance to the manufacturer for which the notification is effective. Its component-status guidance sets out these checks.
An identical chemical from an unrelated, unlisted manufacturer is not covered by that FCN merely because its identity matches. That source needs an applicable regulatory basis, which may be another FCN or a different route recognized by FDA. The notification number cannot resolve a gap in supplier traceability.
A buyer's FCN checklist
Use these checks when assessing a supplier's claim. They are practical steps based on FDA's guidance, not an FDA-prescribed form.
- Match the substance identity and specifications to the full inventory record.
- Confirm that the supplied material comes from the manufacturer or supplier covered by the notification.
- Compare the proposed food-contact use with the record's intended use and limitations.
- Keep supplier evidence that supports traceability. Ask for a manufacturer's letter of guaranty covering the intended use where appropriate.
- Check current effectiveness rather than relying only on an old downloaded record.
- Assess the finished material's other constituent substances separately.
FDA supports the identity, source, use and guaranty checks in its component-status guidance. A manufacturer's letter is supplier evidence, not an FDA-issued certificate. It does not replace reading the applicable authorization.
Missing records and changes in effectiveness
A missing FCN search result does not, by itself, mean a material is unlawful. Other possible bases include applicable food additive regulations in 21 CFR 174–179, GRAS status, prior sanctions and Threshold of Regulation exemptions. FDA lists these alternatives. Ask the supplier which basis applies to the substance and intended use.
A Threshold of Regulation exemption is issued by FDA for a specified use. Unlike an FCN, it is generally applicable regardless of manufacturer or supplier, subject to its terms. A supplier cannot self-declare an "FCN exemption" based on low migration alone. FDA explains the exemption route.
Check effectiveness again when reviewing older records. FDA's rule changes effective May 21, 2024, address determinations that an FCN is no longer effective. Grounds include abandonment of production, supply or use. The final rule sets out these changes.
In January 2025, FDA announced that 35 FCNs for PFAS-containing substances used in paper and paperboard food packaging were no longer effective. Manufacturers or suppliers had abandoned the intended applications. This was not a universal ban on all PFAS food-contact uses or a finding that all 35 uses were unsafe. FDA's announcement explains the scope.
RegAffairs AI's answer about food contact notifications and supplier reliance explains the general rule. Coverage for a purchase depends on the identified source, substance and notified use.