The U.S. Food and Drug Administration (FDA) has issued a final rule to amend regulations 21 CFR 170.105 and 21 CFR 170.102 on how and when FDA may determine that a food contact notification (FCN) is no longer effective. Making its administrative processes more efficient through rulemaking is part of FDA’s efforts to enhance its approach to food chemical safety.

An effective FCN authorizes the use of a food contact substance from the manufacturer or supplier identified in the FCN.

The new changes will increase the efficiency of FDA’s FCN program by allowing the agency to determine an FCN is no longer effective for reasons other than safety. The changes also enable FDA to more effectively respond to new information on the safety and use of food contact substances. A list of effective FCNs can be found on FDA’s website.

Before issuing the final rule, FDA could only determine that an FCN is no longer effective based on safety concerns. As part of the process, manufacturers and suppliers could show why an FCN should continue to be effective after FDA would provide notice of its determination that the FCN is no longer effective.

The final rule issued today provides more flexibility and reduces redundancy in the agency’s regulatory processes. Under the final rule, FDA could determine that an FCN is no longer effective when the manufacturer discontinues its use based on reasons other than safety; for example, when the manufacturer no longer produces, supplies, or uses the food contact substance (referred to as abandonment). The final rule also gives manufacturers or suppliers an opportunity to provide input before FDA determines that an FCN is no longer effective, which helps provide the agency with all relevant information before making a determination. Additionally, the final rule allows FDA to declare an FCN no longer effective if it provides a duplicative authorization (for example, the use of the food contact substance is already authorized by a food additive regulation or the subject of an issued threshold of regulation exemption).  

The final rule keeps in place FDA's ability to revoke an authorization based on safety concerns. FDA can still declare an FCN no longer effective if the manufacturer or supplier does not provide the necessary data or information to address our safety concerns. Also, FDA can still revoke authorizations based on safety concerns even if the notifier decides to abandon the authorized use.

As provided under FDA’s regulations, the agency will publish a notice of its determination in the Federal Register, and the date of publication is when an FCN is no longer effective. When an FCN is no longer effective, the use of the food contact substance as described in the FCN is no longer authorized.  In addition, FDA intends to update its list of effective FCNs on the agency’s website.