FDA Declares Specific Food Contact Notifications Ineffective, Affecting Multiple Substances

Background on FDA’s Decision

In a move aligning with recent regulatory amendments under 21 CFR 170.105, the FDA determined that FCNs become ineffective when the authorised substances are no longer produced or supplied. This decision stems from voluntary notifications submitted by manufacturers, who informed the FDA of their intent to discontinue the production, supply, or use of specific food contact materials. The agency confirmed these declarations and officially marked the listed FCNs as "abandoned." This action allows for regulatory clarity while maintaining consumer safety​​.

Food Contact Substances Affected

The FDA’s determination impacts a wide range of FCSs commonly used in food packaging, storage, and processing applications. These substances include:

Fluoropolymers and Perfluoroalkylethyl Compounds: These are used for grease-proofing and moisture resistance in food packaging. Examples include fluorinated polyurethane anionic resin and copolymers of perfluoroalkylethyl acrylate.Resins and Reaction Products: Resins like diphosphoric acid polymers and reaction products involving tetrafluoroethylene telomers and epichlorohydrin are affected. These materials are widely employed in coatings for food-contact articles.Methacrylate Copolymers: Copolymers such as 2-propenoic acid and glycidyl methacrylate derivatives, used for adhesives and sealing applications, are included.Polymer Additives: Certain polymer additives like ammonium salts of perfluoropolyether dicarboxylic acid and sodium salts of copolymers are part of the discontinued notifications. These additives are typically found in specialised food-contact surfaces​.

Compliance Deadlines and Grace Period

While most of these FCNs became ineffective on January 6, 2025, a specific set of substances listed in Table 2 of the FDA notice remains authorised until June 30, 2025. These include copolymers used in coatings and adhesives, provided they were produced or supplied before the effective date. This phase-out period allows stakeholders to use existing inventories while maintaining compliance with FDA regulations​​.

Environmental and Regulatory Adjustments

The FDA determined that this action would not result in any significant environmental impact, as per 21 CFR 25.32(m). In addition, the agency has updated its inventories of both effective and non-effective FCNs on its official website. This ensures stakeholders can access the latest information on food contact materials that are compliant with federal regulations​.