Regulatory Impact Analysis
The proposed 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 proposed rule would 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. Estimated cost savings of the proposed rule to manufacturers and suppliers and FDA range from zero to $0.5 million, with a central estimate of $0.1 million, annualized over 10 years at a 7 percent discount rate in 2020 dollars. Estimated annualized cost savings range from zero to $0.4 million, with a central estimate of $0.1 million, discounted at 3 percent. We estimate that there will be little to no costs associated with the proposed rule.
Federal Register: 87 FR 3949, January 25, 2022