Frequently Asked Questions on Food Contact Notifications: Who can File?
Can a supplier rely on the FCN obtained by its customers to sell to other customers?
No. FDAMA makes clear that only the submitter and its customers may rely on a notification.
Thus, if a manufacturer of a new polymer obtains a notification, its supplier of the monomer used to make the polymer can rely on the notification to market the monomer only to the notifying company, not to a third company.
Likewise, if film manufacturer A obtains a notification on a single compound X contained in the film, the supplier of compound X may not rely on the notification to sell compound X to other film manufacturers. The notification applies only to film manufacturer A and its customers.
Is there anything in the legislative history of FDAMA to indicate that the filing of an FCN can only be made by special classes of manufacturers or suppliers?
No. The legislative history makes it quite clear that anyone eligible to file a petition may file an FCN as well. FDA has also explicitly stated in its Administrative Guidance that anyone may file an FCN, and has accepted notifications for companies at various points in the chain of commerce for an FCS.