Chemical Additives: Premarket Notifications

“Premarket notification” means that manufacturers and users must advise the FDA if they plan to use something that will contact food but has not been approved before and is not on the database of indirect additives. The process for premarket notification requires that the manufacturer or user provide information that demonstrates that the product is safe for the application intended. The premarket notification for food contact substances is the primary method by which the FDA authorizes the use of food additives that are food contact substances. There are several hundred substances in the inventory, with new ones being posted to the FDA website as appropriate.