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  1. HFP Constituent Updates

FDA Issues Final Rule to Revise Procedures and Update Reasons for Revoking the Authorizations for Food Contact Substances

Constituent Update

March 21, 2024

Today, the U.S. Food and Drug Administration (FDA) issued a final rule to amend our regulations (21 CFR 170.105 and 21 CFR 170.102) on how and when the FDA may determine that a food contact notification (FCN) is no longer effective.  An effective FCN authorizes the use of a food contact substance from the manufacturer or supplier identified in the FCN. These changes will increase the efficiency of the FDA’s FCN program by allowing the FDA to determine an FCN is no longer effective for reasons other than safety. These changes also enable the 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 the FDA’s website.

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

The final rule issued today provides more flexibility and reduces redundancy in our regulatory processes. Under the final rule, the FDA could determine that an FCN is no longer effective when the manufacturer discontinues its use based on reasons other than safety, for example, 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 the FDA determines that an FCN is no longer effective, which helps provide the FDA all relevant information before making a determination. Additionally, the final rule allows the 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 the FDA's ability to revoke an authorization based on safety concerns. The 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, the FDA can still revoke authorizations based on safety concerns even if the notifier decides to abandon the authorized use.

As provided under the FDA’s regulations, the FDA will publish a notice of our 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, the FDA intends to update its list of effective FCNs on the FDA’s website.

Making our administrative processes more efficient through rulemaking is part of our enhanced approach for food chemical safety.

For more information, see the Federal Register Notice.

Additional Information

 

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