Food Additives: Food Contact Substance Notification That Is No Longer Effective; Proposed Rule

The Food and Drug Administration (FDA or we) is proposing to amend its regulations relating to the procedures by which we determine that a premarket notification for a food contact substance (FCN) is no longer effective. The proposed rule, if finalized, would, among other things, ensure that manufacturers or suppliers have the opportunity to provide input before we could determine that an FCN is no longer effective. The proposed rule also would provide additional reasons that could be the basis for FDA to determine that an FCN is no longer effective. We are proposing these changes to better enable FDA to respond to new information on the safety and use of food contact substances, as well as manufacturers' business decisions, which would also improve our FCN program's efficiency.