EU adopted a draft ban on Bisphenol A

Oct 2024. In June 2024, the European Commission adopted a draft regulation to ban the use of bisphenol A and other bisphenols and bisphenol derivatives in food contact materials (D097818/03^[1]). Upon publication, this will be included as an amending regulation to Regulation (EU) No. 10/2011^[2] on food contact materials. The currently valid Specific Migration Limit (SML) for bisphenol A of 0.05 mg/kg will therefore be repealed upon entry into force. However, various provisions on transitional periods are planned. The regulation is expected to be published by the end of 2024.

Key contents of the draft at a glance

The use of bisphenol A and its salts in defined food contact materials will be banned.
The presence of bisphenol A in food contact materials will be 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 draft 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 drafted 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].

Analysis of bisphenols at Eurofins

The experts of the competence centre for organic contaminants of the Eurofins laboratory network for food and feed analysis in Germany offer you the analysis of bisphenol A and further bisphenols in packaging materials and food. A decrease of the limits of quantification (LOQ) is currently ongoing in order to be able to better assess a possible exhaustion of the lower TDI.

In case of any questions please do not hesitate to contact your personal account manager or send us your e-mail:

Relevant Sources

[1] D097818/03: Draft regulation of the EU Commissionon 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