Food Additives: Food Contact Substance Notification That Is No Longer Effective

The Food and Drug Administration (FDA or we) is amending its regulations relating to the procedures for determining that a premarket notification for a food contact substance (FCN) is no longer effective. The final rule provides additional reasons that could form the basis for FDA to determine that an FCN is no longer effective. The final rule also ensures that manufacturers or suppliers have the opportunity to provide input before we determine that an FCN is no longer effective. We are making these changes to allow FDA to respond better to new information on the safety and use of food contact substances (FCSs), as well as manufacturers' business decisions, and also improve the efficiency of the premarket notification program.