Food Contact Notifications (FCNs)

FDA’s Food Contact Notification (FCN) Program helps manage the safety of food contact materials such as food packaging and manufacturing equipment. Substances used for this purpose are referred to as Food Contact Substances (FCS). An FCN is required for any new uses of FCSs that are food additives.

When submitting an FCN, data are required to demonstrate the substance is safe for its intended use, including information on chemical identity, intended conditions of use, estimation of the dietary intake of the FCS, and toxicity and environmental information. In addition, an FCN must include an environmental assessment (EA) or claim of categorical exclusion. 

The U.S. FDA Center for Food Safety and Applied Nutrition reviews an FCN submission during the “phase one” review meeting. If the FCN is considered to be complete, a “phase two” review period will begin. If there are no concerns at the end of the phase two review, the FCN becomes effective 120-days after submission. However, if FDA deems an FCN not acceptable and does not receive the required additional information within ten days of the request, FDA may deem the notification incomplete and terminate the review processes.

TSG’s consultants assist clients throughout the entire FCN process. This includes providing regulatory guidance, assembling the application and ensuring that it contains all required information, conducting required assessments, and promptly and accurately responding to FDA questions during the review process. TSG’s toxicologists apply highly sophisticated quantitative modeling techniques to characterize potential dietary exposures, develop risk assessments, and establish if additional testing is required. TSG’s scientists are also experienced in preparing the environmental assessment that is required for an FCN.