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.
The U.S. Food and Drug Administration (FDA) established the Division of Food Contact Substances within the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (CFSAN), to ensure components of food contact articles, including food packaging and processing equipment, are safe for their intended use. These articles are composed of food contact materials, that contain or are made of food contact substances (FCSs) which fall under the categories described in the table below. FCSs are typically included in coatings, plastics, paper, adhesives, colorants, antimicrobials, and antioxidants. FCSs are evaluated primarily through the food contact notification (FCN) program.
Federal law requires companies who wish to use a food contact substance to submit Food Contact Substance Notifications (FCNs) to FDA prior to marketing the product. The FDA has a mandated 120-day time-period to review that submission. If the agency does not express any objections about the safety of the substance in that time-period, then the company can legally market the product. An effective FCN applies only to the food contact substance that is the subject of the FCN and is applicable to the manufacturer/supplier listed within the notification.
Food Contact Substance Category Terms
- Prior Sanctioned
- Food Additive
- Threshold of Regulation Exemption
- Indirect Food Additive
- Food Contact Substance