U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. About FDA
  3. Reports, Manuals, & Forms
  4. Reports
  5. Economic Impact Analyses of FDA Regulations
  6. Food Additives: Food Contact Substance Notification That Is No Longer Effective (Proposed Rule) Preliminary Regulatory Impact Analysis
  1. Economic Impact Analyses of FDA Regulations

Food Additives: Food Contact Substance Notification That Is No Longer Effective (Proposed Rule) Preliminary Regulatory Impact Analysis

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.

Food Additives: Food Contact Substance Notification That Is No Longer Effective Preliminary Regulatory Impact Analysis (PDF- 356KB)

Federal Register: 87 FR 3949, January 25, 2022

Docket: FDA-2021-N-0403

Back to Top