Under the regulation, hazardous bisphenols other than BPA may be authorized for specific food contact applications following a safety assessment. EFSA's new guidance specifies the information necessary to support these assessments, including data on immunotoxicity, developmental and reproductive toxicity, metabolic effects, and toxicokinetic properties.

The guidance establishes toxicological data requirements based on the extent to which a substance migrates from food contact materials into food. Notably, EFSA has requested additional toxicological data beyond standard genotoxicity testing even at the lowest migration level, below 0.05 milligrams per kilogram of food, reflecting concerns about potential adverse effects from low-dose exposure to BPA and structurally related compounds.

The document also describes recommended in vivo, in vitro, and in silico testing approaches, as well as migration testing strategies for non-plastic food contact materials. EFSA stated that the guidance should also be considered when assessing bisphenols not currently classified as hazardous to help prevent the substitution of BPA with similarly harmful alternatives.

The publication follows the EU's adoption of its BPA ban in December 2024, which entered into force in January 2025. The European Commission subsequently published guidance for industry to support implementation of the restrictions, including provisions for transitional periods and exemptions.

EFSA's new guidance complements its existing requirements for the safety assessment of substances used in food contact materials, providing a framework for evaluating the safety of other bisphenols as industry transitions away from BPA.