EU imposes ban on bisphenol A in food contact articles

This legislation will affect plastics which are intended to come into contact with food.

12th March 2025

Commission Regulation (EU) No 10/2011 has been amended.

The Commission Regulation (EU) No 10/2011 has been amended to implement a prohibition on the use of bisphenol A (BPA) in plastics which are intended to come into contact with food. This is the 18th amendment to (EU) No 10/2011. The amendment was published on 20th January 2025 and incorporates the requirements of Commission Regulation (EU) 2024/3190.

BPA was previously listed as an approved monomer and starting substance for the manufacture of plastics intended for food contact applications, under Annex I of Commission Regulation (EU) No 10/2011 and subject to a specific migration limit (SML) of 0.05 mg/kg. It was banned from use in polycarbonate infant feeding bottles and cups, and in varnishes applied to packaging of food specifically intended for young children, such as formula and baby food.

In 2016, the EU Commission issued a mandate to review the use of BPA in food contact materials. This was completed in 2023 and concluded that exposure to BPA can have adverse effects on the human immune system. As a result, a revised tolerable daily intake (TDI) was established, which was 20,000 times lower than the previous value. This means that even very amounts of BPA migrating into food from plastic materials could result in the new TDI being exceeded, and so the existing specific migration limit for BPA was insufficient to protect human health.

Currently, there are no analytical methods available that would reliably and consistently quantify the migration of BPA at the level of an SML that would be derived from the newly established TDI. Therefore, a complete prohibition on the use of BPA in the manufacture of all food contact articles and components has been enacted. This applies to all components in which BPA may be used, including adhesives, rubbers, ion exchange resins, plastics, printing inks, silicones, varnishes and coatings.

Other uses

As well as acting as a monomer in the production of plastics, BPA can also be used to manufacture other starting substances, such as bisphenol-A diglycidyl ether (BADGE). Although this use as an intermediate is not prohibited under the new regulations, food contact materials that have been made using bisphenol derivatives must not contain any residual BPA. There are also concerns that the prohibition on the use of BPA may result in other hazardous bisphenols being used as alternatives.

To address this, Commission Regulation (EU) 2024/3190 states that hazardous bisphenols and derivatives are also prohibited from use in food contact materials and articles, unless their use has been authorised by the European Food Safety Authority. A hazardous bisphenol or derivative is classified as one which has a harmonised classification of Categories 1A or 1B – ‘mutagenic, carcinogenic or toxic to reproduction’, or Category 1 – ‘endocrine disrupting’.

This prohibition upon the use of BPA and other hazardous bisphenols will come into force from 20th July 2026. Food contact articles which complied with the previous specific migration limit for BPA may continue to be placed on the market until this date. An extended transition period applies for certain applications, including single-use food contact articles for the preservation of fruit, vegetables and processed fish, and repeat-use food contact articles used as professional food production equipment.

The new restrictions will apply to such items from 20th July 2028. Companies can also apply for authorisation to use BPA and other hazardous bisphenols for specific purposes. In order to do so, an application must be submitted in accordance with Article 9 of Commission Regulation (EC) 1935/2004. The European Food Safety Authority will then make a decision on whether to grant the authorisation, and will maintain a Union List of BPA and other hazardous bisphenols and derivatives authorised for specific uses. Two such authorisations have already been granted. These are i) polysulphone filtration membrane assemblies and ii) liquid epoxy-based varnishes to be applied to food contact vessels with a capacity of over 1000 L.

For all applications which have not been granted an authorisation, once the applicable dates have passed, suppliers will need to ensure that their products are compliant with the new requirements, and that their declaration of conformity with Regulation (EC) No 1935/2004 includes this information. Where testing is used to verify compliance, the test method used must be extraction-based and must have a detection limit of 1 µg/kg.

It is recommended that manufacturers and retailers of food contact articles discuss the use of BPA and other bisphenols with their supply chain as soon as possible to ascertain whether these are used, and to take steps to ensure compliance once new regulations come into force.

Please email chemistry@satra.com for further information about this new legislation or for testing enquiries for food contact compliance.