EU ban on Bisphenol A
Eurofins extends range of analyses to bisphenol S and bisphenol B in foodstuffs
April 2025 (update). In December 2024, the EU published Regulation (EU) 2024/3190[1] to ban the use of bisphenol A and other bisphenols and bisphenol derivatives in food contact materials. The Regulation was included as an amending regulation to Regulation (EU) No. 10/2011[2] on food contact materials. The previous valid Specific Migration Limit (SML) for bisphenol A of 0.05 mg/kg was therefore repealed upon entry into force on 20 January 2025. However, there are various provisions on transitional periods.
Key contents of the Regulation at a glance:
- The use of bisphenol A and its salts in defined food contact materials is banned.
- The presence of bisphenol A in food contact materials is banned, even if they were produced using other bisphenols or bisphenol derivatives.
- The use of other hazardous bisphenols and bisphenol derivatives, for which authorisations can be applied for under certain conditions, is also regulated.
- Migration of bisphenol A must not be detectable according to Annex III of the Regulation.
- Specific detection methods for bisphenols and bisphenol derivatives in food contact materials are defined; with a detection limit of 1 µg/kg unless otherwise specified by the European Union reference laboratory, the detection limit is 1 µg/kg.
- Transitional periods are laid down for various food contact materials.
What is bisphenol A?
Bisphenols are compounds from the group of diphenylmethane derivatives. Bisphenol A, chemically also known as 2,2-bis-(4-hydroxyphenyl)-propane, is one of the best-studied substances in this group. Bisphenol A is used in the production of polycarbonates and epoxy resins as well as in the production of interior coatings for beverage and food cans. It can also be used in printing inks, adhesives and other materials that are part of finished food contact materials. While the plastics themselves are stable, there is a possibility that small amounts of bisphenol A may migrate from the plastic as a residue. The use of bisphenol A in the production of baby bottles has been banned in the EU since 2011, and a ban on bisphenol in thermal paper has been in force since 2020.
Toxicological assessment of bisphenol A
The ban on bisphenol A in food contact materials follows the European Food Safety Authority’s (EFSA) scientific opinion on the reassessment of public health risks associated with the presence of bisphenol A (BPA) in food, published on 19 April 2023. In this opinion, a tolerable daily intake (TDI) of 0.2 ng BPA/kg body weight per day was set. This means a reduction of the previous temporary TDI of 4 µg/kg bw by a factor of 20,000. However, the European Medicines Agency (EMA) and the German Federal Institute for Risk Assessment (BfR) reject this TDI, citing scientific and methodological inconsistencies.
Bisphenol A is an endocrine disruptor due to its hormonal effects. In 2016, the European Commission categorised bisphenol A as toxic for reproduction (category 1B), followed by a classification by the European Chemicals Agency (ECHA) in 2022 as a substance of very high concern (SVHC)[3].
Draft Monitoring Recommendation for bisphenol A, bisphenol S and other bisphenols
The EU Commission is currently working on a Monitoring Recommendation for bisphenols in food in order to also examine information on the unintentional introduction of bisphenols, for example from recycled paper and cardboard.
NEW: Analysis of bisphenol S and bisphenol B in food is now also possible
The experts of the Competence Centre for Organic Contaminants of the Eurofins Food & Feed Testing laboratory network offer you the analysis of bisphenols in packaging materials and food.
In addition to bisphenol A and bisphenol F, the analysis of bisphenol S (BPS) and bisphenol B (BPB) can now be ordered in foodstuffs.
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Would you like to find out more about our testing solutions, or do you need tailored analytical support? Contact us today to get in touch with our experts.
Written by:
Sindy Böhme
Eurofins WEJ Contaminants GmbH
Eurofins Consumer Product Testing GmbH
Relevant documents
[1] Commission Regulation (EU) 2024/3190 on the use of bisphenol A (BPA) and other bisphenols and bisphenol derivatives [...] intended to come into contact with food
[2] Consolidated text: Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food
[3] ECHA/NR/22/08: Group assessment of bisphenols identifies need for restriction