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Forthcoming Chemistry Recommendations for the Preparation of Premarket Submission for Food Contact Substances

On June 30, 2022, the U.S. Food and Drug Administration (FDA) released an updated list of draft and final guidance topics. These topics are a priority for the FDA Foods Program to complete during 2022. Most notably, the Agency added “Draft Guidance for Industry on Preparation of Premarket Submission for Food Contact Substances (Chemistry Recommendations)” and “Guidance for Industry on Best Practices for Convening a GRAS Panel” to the list of FDA topics expected this year.

The Draft Guidance for Industry on Preparation of Premarket Submission for Food Contact Substances is expected to describe changes to the default factors used to estimate exposure to food contact substances (FCSs) in Food Contact Notifications (FCNs). As previously reported, these factors have not been updated for many years and are integral to determining the safety of the substances in food packaging.

The updated list includes potential topics that FDA intends to issue by the end of December 2022. Although the guidance is not legally enforceable, these guidance documents provide valuable insight into the Agency’s current thinking on a topic. FDA currently intends to publish all draft and final guidance topics on the list by the end of this year.