On November 6, 2023, the U.S. Food and Drug Administration (FDA) announced the full implementation of its updated Center for Food Safety and Applied Nutrition (CFSAN) Online Submission Module (COSM). Updates to COSM allow stakeholders to send fully electronic regulatory submissions, including food-contact notifications (FCNs), directly to FDA’s Office of Food Additive Safety (OFAS), thereby eliminating the need to use FDA’s Electronic Submission Gateway (ESG).

On October 27, 2023, California’s Office of Environmental Health Hazard Assessment (OEHHA) issued a Proposed Rulemaking to amend the warning requirements under Proposition 65 (otherwise known as the Safe Drinking Water and Toxic Enforcement Act of 1986).

As proposed, California’s Office of Environmental Health Hazard Assessment (OEHHA) has finally adopted a No Significant Risk Level (NSRL) for antimony trioxide of 0.13 microgram (µg) per day by the inhalation route. California’s Office of Administrative Law approved the rulemaking and filed it with the Secretary of State on October 3, 2023. The effective date for the NSRL is January 1, 2024.

The U.S. Food and Drug Administration (FDA) recently added two new substances to its Inventory of Effective Food Contact Substances (FCS) Notifications. The newly listed substances and the manufacturers are listed below.

On October 23, 2023, Maine’s Department of Environmental Protection (DEP) released an updated draft rule, 06-096 C.M.R. Chapter 80 (“Reduction of Toxics in Packaging”), on the implementation of the State’s Toxics in Packaging Law. The draft rule imposes a sales prohibition for certain food packaging containing intentionally added per- and polyfluoroalkyl substances (PFAS) and also prohibits the sale of food packaging to which phthalates have been intentionally introduced in more than incidental amounts.  

Importers of Finished Articles Made with PFAS Must Also Report 

The U.S. Environmental Protection Agency (EPA) has issued a final rule that requires the reporting of extensive information on potentially thousands of per- and polyfluoroalkyl substances (PFAS) under the Toxic Substances Control Act (TSCA). It captures all PFAS compounds manufactured or imported into the U.S.

While the current Food Contact Notification (FCN) process serves the U.S. Food and Drug Administration’s (FDA) reassessment initiative, the Agency is in the process of implementing changes that will support FDA’s efforts to establish a framework for routing systematic review of food-contact substances (FCS) through ongoing monitoring after they are on the market.

On October 7, 2023, California Governor Gavin Newsom signed AB 418—which bans the manufacture, sale, and distribution of any food products that contains brominated vegetable oil, potassium bromate, propylparaben, and red dye #3—into law. The ban becomes effective in 2027.

Maine has extended the effective date of its per- and polyfluoroalkyl substances (PFAS) notification requirement by two years to January 1, 2025, following the passage of HP 138/LD 217 (“An Act to Support Manufacturers Whose Products Contain Perfluoroalkyl and Polyfluoroa