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  1. Economic Impact Analyses of FDA Regulations

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

The final rule amends the Food and Drug Administration’s (FDA or we) food additive regulations relating to premarket notifications for food contact substances (FCNs) and the procedures by which we determine that an FCN is no longer effective. The final rule will allow manufacturers or suppliers of food contact substances (FCSs) to request that FDA determine that an FCN is longer effective for reasons other than safety. Cost savings of the final rule to manufacturers and suppliers and FDA range from zero to $0.4 million, with a central estimate of $0.1 million, annualized over ten years at a 2 percent discount rate. We estimate that there will be little to no costs associated with the final rule.

Food Additives: Food Contact Substance Notification That Is No Longer Effective (PDF 292 KB)

Federal Register: 89 FR 20306
Publication Date: March 22nd 2024
Docket: FDA-2021-N0403

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