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.