TOX/2025/47 Annex A

Introduction

TOX/2025/47

Last updated: 05 December 2025

This is a background paper for discussion. It has not been finalised and should not be cited.

1.              Bisphenol A (BPA) is used as a monomer in the manufacture of polycarbonates (PC), epoxy resins and other polymeric materials, and certain paper products (thermal printing). BPA has been prohibited in coatings and varnishes for food contact materials (FCMs) intended for infants and young children since 2018. However, it continued to be used and authorised in the European Union (EU) and United Kingdom (UK) for applications such as reusable bottles, tableware and storage containers, thermal paper coatings and protective linings of food and beverage cans and vats. Where BPA was permitted at the time, operators had to ensure that BPA observed the specific migration limit (SML) of 0.05 mg/kg (EFSA, 2021). The SML set in the EU and UK was based on the European Food Safety Authority’s (EFSA) 2015 evaluation of BPA and a Temporary Tolerable Daily Intake (t-TDI) of 4 µg/kg body weight (bw) per day.

2.              Following a mandate from the European Commission (EC) in 2016 to re-evaluate the risk to public health related to the presence of BPA in foodstuffs, EFSA established a new TDI of 0.2 ng BPA/kg bw per day in their final evaluation in 2023. Although this final TDI was higher than the initially proposed level, mean and high level consumers of all age groups would exceed the new TDI by 2-3 orders of magnitude.

3.              In December 2024, the EU adopted a ban on the use of BPA in FCMs, which took effect in January 2025, with an 18-month phase-out period for industry compliance. The ban means that BPA will no longer be allowed in products that come into contact with food or drink, e.g. coating of metal cans, reusable plastic bottles, water coolers and other kitchenware. The EU ban also included BPA’s salts and other bisphenols and bisphenol derivatives, as a precautionary principle, due to shared characteristics with BPA, such as similarities in structure and activity (EC (No) 2024/3190). Some bisphenols, e.g. bisphenol S (BPS), have already been subject to harmonised classification and have been listed in Part 3 of Annex VI Regulation (EC) No 1272/2008 as they have demonstrated hazardous properties to human health, i.e. reproductive toxicity.