Bisphenol A in Food-Contact Materials: EU Obligations for Businesses in 2026

The European ban on bisphenol A ("BPA") in materials and articles intended to come into contact with food has now entered its operational phase.

With the adoption of Regulation (EU) 2024/3190, the European Commission introduced one of the most significant reforms in recent years in the field of food contact materials ("FCMs"). The Regulation prohibits the use of BPA and other "hazardous" bisphenols in the manufacture of food contact materials and articles and also prohibits the placing on the EU market of materials and articles containing those substances.

The subsequent Regulation (EU) 2026/250 amended certain provisions of the 2024 Regulation, providing important clarifications regarding the available derogations, testing methods, the transitional regime applicable to businesses and the content of the declaration of compliance.

The rationale behind the EU reform

For several decades, BPA has been widely used in the manufacture of plastics, ion-exchange resins, varnishes and coatings, rubber products, metal packaging, adhesives, silicones and printing inks intended for food contact applications.

BPA is a chemical substance that may pose a risk to human health where it migrates from the food contact material into the food itself, potentially exposing the final consumer to harmful effects.

Before the adoption of Regulation (EU) 2024/3190, EU legislation permitted the use of BPA in food contact materials provided that its migration did not exceed the specific migration limit ("SML") established by the European Commission. Its use had already been prohibited, however, in materials intended to come into contact with infant formula and food intended for infants and young children.

The European Union's decision to prohibit the use of BPA in food contact materials follows the updated scientific opinion issued by the European Food Safety Authority ("EFSA") in 2023. That opinion reduced the tolerable daily intake of BPA by a factor of 20,000 compared with EFSA's 2015 assessment and identified a number of potential adverse effects on human health.

In light of this updated scientific evidence, the EU legislature concluded that the previous regulatory framework, based solely on compliance with a specific migration limit, no longer provided an adequate level of protection. It therefore introduced an almost complete prohibition on the use of BPA in the manufacture of food contact materials.

The new restrictions also extend to other bisphenols classified by EFSA as "hazardous".

Regulation (EU) 2024/3190

Prohibition on the use of BPA and other hazardous bisphenols

The key innovation introduced by Regulation (EU) 2024/3190 is the general prohibition on both the use of BPA and other bisphenols classified as hazardous in the manufacture of food contact materials and the placing on the EU market of materials and articles containing such substances (Articles 3 and 5).

Derogations from the prohibition

The only exceptions to the prohibition on the use of BPA are the specific applications listed in Annex II to the Regulation, and only where BPA is used in full compliance with the conditions expressly laid down therein.

For example, BPA may still be used in the manufacture of varnishes and coatings where it is employed as a monomer or starting substance in the production of liquid epoxy resins intended for application to self-supporting materials or articles with a capacity exceeding 1,000 litres that are designed to come into contact with food. This derogation applies only where migration into food is not detectable and the final food contact materials or articles are cleaned and washed before first use.

As regards hazardous bisphenols other than BPA, their use is permitted only where two cumulative conditions are met. First, the intended use must fall within one of the specific applications listed in Annex II. Secondly, the operator must obtain a specific authorisation from the European Commission following a favourable opinion issued by EFSA, as provided for in Article 6 of the Regulation.

"Residual BPA"
 

A particularly significant provision, which is emblematic of the approach adopted by the European Union towards BPA, is contained in Article 4 of Regulation (EU) 2024/3190.

Under that provision, food contact materials and articles manufactured using bisphenols other than BPA and bisphenols regarded as hazardous, or derivatives thereof, must not under any circumstances contain “residual BPA”.

The specific purpose of this provision is to prevent the prohibition on the use of bisphenol A from being circumvented through the use of alternative substances whose synthesis nevertheless leaves BPA residues in the final product.

Declaration of compliance

Regulation (EU) 2024/3190 also reinforces the traceability requirements applicable to the documentation accompanying food contact materials and articles.
More specifically, Article 8 requires a declaration of compliance to accompany the food contact material or article at all stages of its placing on the Union market, with the sole exception of the final retail stage.

The declaration serves to certify the compliance of the material or article with EU legislation governing materials and articles intended to come into contact with food.
It must contain all the information specified in Annex III to the Regulation, including, expressly, “the list of bisphenols or bisphenol derivatives used in the manufacture of the food contact material or article”.

Transitional arrangements

As regards the timetable for the application of the requirements introduced by Regulation (EU) 2024/3190, the general adjustment and compliance period, commonly referred to as the “transitional period”, expired on 20 July 2026.
During that period, it remained permissible to place on the Union market both single-use final food contact articles and repeat-use final food contact articles containing BPA which did not comply with the new rules but remained compliant with the legislation applicable before the adoption of the 2024 Regulation.
The relevant transitional provisions are laid down in Articles 11 and 12 of Regulation (EU) 2024/3190.

As from 20 July 2026, single-use and repeat-use final food contact articles may, as a general rule, be placed on the Union market only where they comply with the requirements concerning bisphenols introduced by Regulation (EU) 2024/3190.

The only temporal derogations concern:

- single-use final articles intended to come into contact with fruit, vegetables and fishery products, as well as articles intended to come into contact with food where a varnish or coating manufactured using BPA has been applied solely to the external metal surface. For those articles, the transitional period for their placing on the Union market expires on 20 January 2028;

- repeat-use final food contact articles used as professional food-production equipment and manufactured using BPA. For those articles, the transitional period for placing them on the Union market likewise expires on 20 January 2028.

Regulation (EU) 2026/250

Slightly more than one year after the entry into force of Regulation (EU) 2024/3190, the European Commission returned to the issue of bisphenols by adopting Regulation (EU) 2026/250.
The latter introduces a number of important technical corrections to the rules adopted in 2024. It does not alter the substantive structure of the regulatory framework, but instead clarifies certain interpretative and practical aspects of the original text.

“BPA salts”

First, through the 2026 intervention, the EU legislature made a purely terminological correction to Regulation (EU) 2024/3190 by deleting the reference to “BPA salts” from Article 3.
Such salts constitute a chemical form already covered by the definition of BPA contained in the Regulation. Accordingly, any distinction between BPA and “BPA salts” was considered unnecessary and technically inappropriate.

Clarification of the derogations from the prohibition on use

Secondly, the European Commission expressly clarified that the derogations set out in Annex II to Regulation (EU) 2024/3190 permit, within the limits of the applications specified therein, not only the use of BPA in the manufacture of food contact materials, but also the placing of those materials on the Union market.
This clarification removes an interpretative uncertainty arising from the original wording of the 2024 Regulation, which had generated considerable concern among operators in the sector.

Clarification of testing methods

Thirdly, Regulation (EU) 2026/250 clarifies that compliance testing of food contact materials and articles against the regulatory requirements applicable to bisphenols must be carried out using testing methods designed to verify the absence of “residual BPA”, rather than merely the absence of BPA as such.
This amendment is fully consistent with the prohibition on the presence of residual BPA laid down in Article 4 of Regulation (EU) 2024/3190.

Amendments to the transitional arrangements

Fourthly, Regulation (EU) 2026/250 introduces specific amendments to the transitional arrangements established in 2024.
These amendments arguably constitute the most significant element of the 2026 Regulation.
More specifically, the European Commission:

- amends the transitional arrangements applicable to single-use final articles intended to come into contact with fruit, vegetables and fishery products, as well as articles intended to come into contact with food where a varnish or coating manufactured using BPA has been applied exclusively to the external metal surface. To remove any possible ambiguity, the Commission specifies that the deadline of 20 January 2028 concerns the first placing of the relevant article on the Union market and not any subsequent transfers along the distribution chain;

- amends the transitional arrangements applicable to repeat-use final articles manufactured using BPA, for which first placing on the Union market was permitted until 20 July 2026. The Regulation clarifies that such articles may remain on the European Union market until 20 July 2027 at the latest, rather than until 20 January 2029 as initially provided for in Regulation (EU) 2024/3190;

- amends the transitional arrangements applicable to repeat-use final articles used as professional food-production equipment containing BPA, for which first placing on the European Union market is permitted until 20 January 2028. It confirms that such articles may remain on the European market until 20 January 2029.

Amendments to the declaration of compliance

Finally, Regulation (EU) 2026/250 also amends the requirements relating to the declaration of compliance set out in Annex III to Regulation (EU) 2024/3190.
It clarifies that the declaration must specify either the identity of the intermediate food contact material or, alternatively, the identity of the final food contact article.
It is therefore no longer necessary to specify both identities, as had initially been required under the 2024 regulatory text.

Why businesses must act without delay

The adoption by the European Commission of Regulations (EU) 2024/3190 and 2026/250 forms part of the broader policy pursued by the EU legislature in recent years in relation to the European agri-food sector.
The ultimate objective of that policy is to enhance food safety throughout the European Union through the continuous review and updating of the legislation governing the agri-food sector.
The rules and requirements adopted in this field have direct implications for consumer health and pursue, among their principal objectives, the replacement, wherever possible, of chemical substances considered hazardous with safer alternatives.

This inevitably requires businesses operating within the European agri-food sector, as well as all undertakings manufacturing, supplying or distributing food contact materials and packaging on the Union market, to ensure the constant and timely updating of their manufacturing processes, of their internal control procedures, of their supplier compliance systems, of their stock-management and inventory planning.
Only by adopting such measures can businesses mitigate the risk that their products will fail to comply with EU law, avoid potential administrative or commercial liability and ensure the continued marketing of their products within the European Union.
Timely compliance also enables businesses to demonstrate a high level of safety, reliability and regulatory control throughout the food supply chain.

Anna Ballerini
Studio Legale de Capoa