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FDA to Propose Rule to Allow Delisting of Food Contact Substances for Non-Safety Reasons

July 14, 2020

The U.S. Food and Drug Administration (FDA) reported in the Spring 2020 Unified Agenda of Regulatory and Deregulatory Actions that it is proposing to amend the food additive regulations to allow a Food Contact Substance Notification (FCN) to become no longer effective for reasons other than safety. FDA also noted that the proposed rule would provide manufacturers or suppliers an opportunity to address any safety concerns earlier in the process before it makes a determination that an FCN is no longer effective.

The Spring 2020 Agenda, which was released June 30th (two months later than usual), did not provide a timetable for the proposal. However, FDA has been working on a draft rule to allow delisting of FCNs for non-safety reasons for some time. During a presentation at Keller and Heckman’s annual Food Packaging Law Seminar in October 2018, Michael A. Adams, Ph.D., Deputy Director of FDA’s Office of Food Additive Safety, told attendees that that fact that an FCS cleared through an FCN cannot be delisted for reasons other than safety is a legitimate concern. He added that FDA was working on a draft rule, as time and resources permit, that would allow the Agency to delist FCNs for non-safety reasons, such as the substance is no longer manufactured or supplied.

Authorization for determining that an FCN is no longer effective is found in 21 Code of Federal Regulations (C.F.R.) § 170.105(a), which states, “[i]f 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.”

A copy of the Spring 2020 Unified Agenda can be found here.