One of the public health responsibilities of the U.S. Food and Drug Administration (FDA) is to ensure the safety of the U.S. food supply. Within that scope, FDA evaluates the safety of substances added to food (i.e., direct food additives) and food contact materials (i.e., food contact substances, FCSs). This presentation will focus on the premarket safety evaluation of FCSs through the food contact substance notification (FCN) process, a premarket approval process by which FDA regulates FCSs. The regulatory framework for the safety evaluation of an FCS, including considerations in the determination of the level of migration of an FCS to food, calculating consumer exposure, and safety assessment, will be discussed.

Safety evaluation of food packaging materials: A regulatory overview of FDA’s food contact substance notification (FCN) program

ACS Spring Meeting 2021

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