FDA to Propose Method to Delist FCSs for Non-Safety Reasons
The U.S. Food and Drug Administration (FDA) plans to issue a proposed rule to amend its food additive regulations to allow a Food Contact Notification (FCN) to become no longer effective for reasons other than safety by September 2019. The deadline for the proposed rule was announced in the Spring 2019 Unified Agenda of Regulatory and Deregulatory Actions.
Authorization for determining that a food-contact substance (FCS) subject to an FCN is no longer effective is found in Title 21 of the Code of Federal Regulations (C.F.R.) § 170.105(a), which states, “If data or other information available to FDA… demonstrate that the intended use of the food contact substance is no longer safe, FDA may determine that the authorizing FCN is no longer effective.” Speaking at Keller and Heckman’s annual Food Packaging Law Seminar in October 2018, FDA’s Deputy Director for the Office of Food Additive Safety, Michael A. Adams, Ph.D., mentioned that this is a legitimate concern and that FDA was working on a draft rule that would allow the Agency to delist FCNs for non-safety reasons, such as that the substance is no longer manufactured or supplied. (Information on this year’s Food Packaging Law Seminar can be found here.)