Food Contact Notification (FCN)
RegulatoryAlso known as: FCN, Food contact substance notification
FDA's pre-market notification process for new food contact substances, specific to the manufacturer and intended use.
What It Means
A Food Contact Notification (FCN) is a submission to FDA for a new food contact substance (FCS) that has not been previously authorized. An effective FCN permits the notifier (and its customers) to market the FCS for the specific intended use described in the notification. Critically, an effective FCN is specific to the manufacturer or supplier that submitted it AND to the conditions of use reviewed by FDA. FDA does not generally require ongoing post-market reporting after FCN authorization. This means the buyer must do more verification, not less. In January 2025, FDA determined that 35 PFAS-related FCNs were no longer effective due to abandonment by their notifiers, demonstrating that food-contact authorization can be revoked and is not a permanent status.
What It Is Not
An FCN is NOT the same as FDA approval. FDA does not 'approve' food contact substances; it reviews the notification and, if it does not object within 120 days, the FCN becomes effective. An effective FCN for one supplier does not cover a different supplier making the same substance. An effective FCN for one use does not cover a different use of the same substance.
Evidence and References
- guidanceFDA Food Contact Substance Program
- enforcementFDA PFAS FCN revocations (Jan 2025)
Related Categories
Need Help Understanding Compliance?
Our directory connects you with manufacturers and labs that meet these standards.