EFSA 10368: guidance on data requirements for bisphenols other than BPA in food contact materials
On 16 October 2026 the European Food Safety Authority published guidance on the data requirements for the safety assessment of bisphenols other than bisphenol A (BPA) and their derivatives when used in food contact materials. The document carries DOI 10.2903/j.efsa.2026.10368 and supplements EFSA’s general Note for Guidance on food contact materials.
The guidance is not a safety opinion or an authorisation for any substance. It sets out the scientific information an applicant should submit so that EFSA can perform a risk assessment for a specific use. Publication responds to obligations under Commission Regulation (EU) 2024/3190, which restricted BPA and provides an authorisation pathway for other hazardous bisphenols under defined conditions.
Migration tiers and data scope
| Migration level | Indicative data scope | Notes |
|---|---|---|
| < 0.05 mg/kg food | At least two in vitro genotoxicity tests; additional toxicological data may be required | Low migration still may need broader data for bisphenols |
| 0.05–5 mg/kg food | Genotoxicity tests + 90-day oral toxicity study + accumulation data | Intermediate exposure |
| 5–60 mg/kg food | Full dataset including reproductive, developmental and long-term studies | High migration |
These thresholds align with the tiered approach used in food contact material assessments. The guidance stresses data proportionate to predicted exposure and substance properties.
Sources: EFSA Journal 2026, DOI 10.2903/j.efsa.2026.10368; Commission Regulation (EU) 2024/3190.
Last modified: 19 October 2026.