Bisphenol A: Clarifications of the new EU regulations

On 20 January 2025, Regulation (EU) 2024/3190 of the European Commission on the use of bisphenol A (BPA) and other bisphenols and bisphenol derivatives with a harmonised classification for specific hazardous properties in materials intended to come into contact with food came into force.

This Regulation lays down specific requirements for 4,4’-isopropylidenediphenol (BPA) (CAS No 80-05-7) and its salts, as well as other hazardous bisphenols and hazardous bisphenol derivatives, with regard to their use in the manufacture of materials and articles intended to come into contact with foodstuffs, such as paints and coatings, plastics, adhesives, rubbers, ion-exchange resins, printing inks and silicones. In particular, it prohibits the use of BPA and its salts in the manufacture of materials and articles intended to come into contact with foodstuffs and the placing on the Union market of materials and articles intended to come into contact with foodstuffs manufactured using BPA.

Guidance Note on the implementation of Regulation (EU) 2024/3190

In December 2025, the European Commission published a Guidance Note on the implementation of the Regulation, with the aim of providing clarification and facilitating the implementation of the Regulation.

The document, structured as a Q&A, serves as a set of guidelines covering the following aspects:
1. Scope of Commission Regulation (EU) 2024/3190
2. Other bisphenols and bisphenol derivatives
3. Compliance and testing
4. Placing on the market
5. Transitional provisions.

A table at the end of the document provides an overview of the transitional periods for food contact materials (FCMs) falling within the scope of the Regulation. In the meantime, some of the transitional provisions relating to single-use final articles intended to come into contact with food have been specified in greater detail in Commission Regulation (EU) 2026/250, issued on 2 February 2026, which amends Regulation (EU) 2024/3190.

Regulation (EU) 2026/250: amending regulation

Regulation (EU) 2026/250 does not make any substantial changes to the prohibitions already in place but corrects linguistic inaccuracies and technical inconsistencies in the text of Regulation (EU) 2024/3190 in order to ensure it can be applied without any interpretative doubts and to guarantee the consistent application of the new rules throughout the European Union.

The main clarifications and new provisions introduced by Regulation (EU) 2026/250 focus on three key areas:
• Consistency in terms and definitions: a significant correction concerns the definition of ‘bisphenol’ within the Regulation. The reference to “BPA and its salts” has been removed from Article 3 of Regulation (EU) 2024/3190, to ensure greater consistency with the definition of bisphenol, which includes BPA in the form of a salt. This amendment was made to clarify that the legislation applies to all chemical forms of BPA.

• Transitional provisions: The 2026 Regulation has removed any ambiguity regarding the transitional provisions for the first placing on the market of single-use end-products containing BPA. In particular, single-use end-products manufactured with BPA that comply with the previous standards may be placed on the market for the first time until 20 July 2026. However, for certain specific materials, such as those intended for the storage of fruit, vegetables and fish products, the transitional period has been extended until 20 January 2028, allowing the sale of packaged products until stocks are exhausted. These more precise deadlines have been introduced to ensure a smooth transition without disrupting production chains. It also clarifies the transitional provisions for the first placing on the market of final FCMs for repeated use and final FCMs for repeated use used as professional equipment for food production in accordance with Articles 12(1) and 12(2)

• Alignment of technical standards and declaration of compliance: The amendments introduced in Regulation (EU) 2026/250 have also clarified the documentation requirements for businesses. The declaration of compliance must now be more specific regarding the identification of intermediate materials and finished articles intended to come into contact with food. Previously, the requirement for identification also included information that could create confidentiality issues for companies.

With the new amendments, the information to be included in the declaration has been clarified to ensure transparency and compliance with the new regulations, avoiding confusion between intermediate materials and final products.

The amendments introduced by Regulation (EU) 2026/250 do not alter the prohibitions already established by Regulation (EU) 2024/3190, but provide greater clarity on how to apply them correctly. Companies in the food contact materials (FCMs) sector must continue to ensure that their products do not contain BPA or other hazardous bisphenols, except for certain authorised specific applications. However, the new clarifications on terminology and transitional provisions offer businesses clearer guidance on compliance with the regulations and on the correct documentation of compliance.

References:

• The Guidance Note on the implementation of Regulation (EU) 2024/3190 is available HERE
• Commission Regulation (EU) 2026/250 is available HERE

Reprinted with permission from SSICA (Italy) of an article prepared by their Packaging Division, Cross-Functional and Multidisciplinary Services Unit. The original document in Italian is available HERE