January 25, 2022
Proposed New Rule to Revise Procedures and Update Reasons for Revoking the Authorizations for FCNs
FDA proposed a new rule to amend our regulation (21 CFR 170.105) on how and when the FDA may determine that a pre-market notification for a food contact substance is no longer effective. Learn more about the proposed changes and how to comment on the proposed rule.
A notification for a food contact substance must contain sufficient information to demonstrate that the substance is safe for the intended use that is the subject of the notification (21 U.S.C. 348(h)(1)). For guidance on the data and information recommended for inclusion in a food contact substance notification, potential notifiers should consult FDA's guidance on chemistry, toxicology, and environmental information recommended in notifications and FDA's administrative guidance concerning formatting of such information.
To meet FDA's environmental requirements under the National Environmental Policy Act (NEPA), a notification must contain either an environmental assessment (EA) or a claim of categorical exclusion as stated under 21 CFR 25.15. Actions requiring preparation of an EA are specified under 21 CFR 25.20 and preparation of an EA is defined under 21 CFR 25.40. CFSAN classes of actions that are categorically excluded from the requirement to prepare an EA are specified under 21 CFR 25.32.
To assure that the appropriate information is submitted for a food contact substance notification, FDA has provided access to an electronic form for notifiers to submit their notification. The form may be either printed and mailed to The Office of Food Additive Safety or the template version of FDA Form 3480 may be downloaded to the user's computer for data entry.
Food contact substance notifications can be submitted securely through FDA’s Electronic Submission Gateway (ESG) using the CFSAN Online Submission Module (COSM).
We are also still receiving physical mail at this time, so you may also submit a notification on a compact disc (CD), digital versatile disc (DVD), or on paper, to
Notification Control Assistant
Office of Food Additive Safety, HFS-275
5001 Campus Drive
College Park, MD 20740
For network security reasons, we are not able to accept submissions on universal serial bus (USB) drives.
After you submit your food contact substance notification, either by ESG or by mail, we recommend that you also email us at email@example.com to inform us that you have submitted the notification.