On March 21, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule aimed at refining regulations concerning food contact notifications (FCNs). FCNs serve to authorize the use of certain substances in food contact materials. The regulatory adjustment is intended to bolster efficiency within the FDA’s FCN program by expanding the criteria under which the agency may determine the effectiveness of an FCN. The rule will be effective on May 21, 2024.
Previously, the FDA could solely deem an FCN ineffective based on safety concerns. However, the new rule empowers the FDA to assess FCN effectiveness for reasons beyond safety considerations. This includes instances such as manufacturer discontinuation of use due to non-safety-related factors. Under the finalized rule, manufacturers and suppliers are provided with an opportunity to provide feedback before the FDA renders a determination on the effectiveness of an FCN. Still, the FDA has the option to declare an FCN no longer effective if the manufacturer or supplier does not provide the necessary data or information to fulfill the required safety criteria.
This regulatory refinement aligns with the FDA’s commitment to enhancing food chemical safety administrative processes (FPF reported) following criticism in recent years (FPF reported). Civil society organizations particularly have highlighted the slow pace of change and the reliance on industry self-reporting to be classified “generally recognized as safe” (GRAS, FPF reported, also here and here).
References
US FDA (March 22, 2024). “Food Additives: Food Contact Substance Notification That Is No Longer Effective.”
US FDA (March 21, 2024). “FDA Issues Final Rule to Revise Procedures and Update Reasons for Revoking the Authorizations for Food Contact Substances.”
Read more
Julia John (March 27, 2024). “US FDA finalises rule to cancel food contact approvals for non-safety reasons.” Chemical Watch News & Insight
