Cumulative risk of bisphenol A analogues in BPA-free food contact materials under EU 2024/3190

Issue/problem

BPA has been progressively restricted in food contact materials (FCMs) since 2011, and Regulation (EU) 2024/3190 now extends controls to other bisphenols and derivatives classified as carcinogenic, mutagenic or reprotoxic (CMR 1A/1B) or category 1 endocrine disruptors. Yet the policy is reactive: industry has spent a decade replacing BPA with equally toxic analogues such as BPS, BPF and BPAF, already widespread in the food chain. Current frameworks still rely on individual substance assessments and do not adequately account for the cumulative risk of simultaneous exposure to multiple bisphenols.

Description of the problem

Regulation (EU) 2024/3190 prohibits BPA and hazardous bisphenol analogues in FCMs, allowing only narrow exemptions where migration is non-detectable (LOD 1 μg/kg), but retains a single-compound assessment model. This does not address the cumulative toxicological burden from concurrent exposure. A gap therefore persists between compliance for individual substances and keeping the total Hazard Index (HI) below 1, exposing the limits of current monitoring in managing systemic risks from combined trace levels.

Results

Structural analogues (BPS, BPF, BPAF) are widespread and show toxicological profiles similar to BPA. Compliance with individual limits under Regulation (EU) 2024/3190 does not necessarily prevent the cumulative HI from exceeding 1, indicating that regulating substances individually fails to capture the total additive impact and signalling a need for stronger safety margins.

Lessons

Public health strategies should shift from individual substance-based limits to regulating bisphenols as a functional class, preventing regrettable substitutions. Dietary safety protocols must adopt cumulative risk assessment methodologies reflecting the additive impact of related compounds. Proactive, multi-analyte monitoring is essential for effective risk management and long-term stability of global food safety policies.

Key messages

• Regulation (EU) 2024/3190 addresses BPA analogues but follows years of “regrettable substitutions.” Policy must now tackle the established presence of toxic mixtures in the food chain.

• Single-compound limits ignore that the cumulative Hazard Index of bisphenol mixtures exceeds safety thresholds; a shift toward group-based regulation is mandatory.