EU Seeks Feedback on Data Requirements for Safety Assessment of Bisphenols in FCMs
Legislation adopted by the European Commission in December 2024 banned the use of Bisphenol A (BPA) in food contact materials (FCMs) while specifying that “hazardous” bisphenols other than BPA may be used for limited food-contact applications, provided that their use has been authorized.
In this context, the European Food Safety Authority (EFSA) has published a draft statement on the data requirements for the safety assessment of hazardous bisphenols other than BPA and their derivatives when used for specific applications in FCMs. The statement is intended to provide a structured and harmonized framework for applicants and risk assessors, aiming to ensure a consistent and robust safety assessment of hazardous bisphenols and their derivatives used in FCMs, while supporting regulatory decision-making within the EU.
The proposed requirements address different migration scenarios and focus on key toxicological endpoints of concern, including immunotoxicity, developmental and reproductive toxicity, and metabolic effects, as well as toxicokinetic properties. At the lowest migration level, additional data beyond standard genotoxicity testing will be requested, reflecting the potential for low-dose adverse effects observed for BPA and structurally related compounds. The statement also specifies the use of in vivo, in vitro, and in silico approaches, including extended one-generation reproductive toxicity studies, targeted immunotoxicity assessments, and studies supporting physiologically based kinetic modeling.
Stakeholders are invited to submit comments on the draft statement no later than May 7, 2025, here.
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