Commission Regulation (EU) 2024/3190 introduces significant restrictions on the use of bisphenol A (BPA) in food contact materials (FCMs), with direct implications for packaging manufacturers and their supply chains. To support consistent implementation, the European Commission has issued detailed clarifications addressing scope, compliance, testing and documentation requirements.
Table of Contents
Scope of the Ban: Paper, Board, and Combined Materials (Q1)
Paper and board are not, in themselves, covered by the scope of Regulation (EU) 2024/3190. The list of materials subject to the regulation does not include these substrates because BPA is not typically used in their manufacture. The regulation instead targets materials where BPA may be intentionally used, such as plastics, epoxy coatings, printing inks, and adhesives. However, when paper or board is combined with any material falling within the regulation’s scope, the resulting food contact article becomes subject to the regulation. In such cases, all applicable obligations, including the requirement for a Declaration of Compliance (DoC), apply to the final article.
Recycled Food Contact Materials (Q2)
Recycled food contact materials may contain very small amounts of BPA or other bisphenols due to incidental contamination originating from recycled input streams, such as plastics, paper, or board. These traces can remain despite cleaning and decontamination processes. Since BPA is not intentionally used in the manufacture of these recycled materials and the contamination cannot be fully controlled, recycled FCMs are considered outside the scope of Regulation (EU) 2024/3190.
Demonstrating Compliance in Practice (Q20)
Compliance with the BPA prohibition can primarily be demonstrated through documentation supporting the DoC. This may include, for example, lists of monomers or starting substances showing that BPA was not used. In such cases, additional testing is optional and left to the discretion of the business operator. Where BPA use is allowed under specific conditions set out in Annex II, operators must show that BPA does not migrate into food above the detection limit, using tools such as migration testing or modelling. If other bisphenols or derivatives are used, compliance with the ban on residual BPA can be demonstrated through analytical testing or impurity data. Operators may rely on representative testing strategies rather than testing every product, provided worst-case scenarios are appropriately addressed.
Is Laboratory Testing Mandatory? (Q21)
The regulation does not impose a general obligation to carry out laboratory analysis. Testing becomes relevant when operators choose it as a means of verification, particularly where BPA migration must be non-detectable or where other bisphenols or derivatives are used and residual BPA is prohibited. The decision to test remains with the business operator.
Detection Limits and Their Application (Q22 and Q23)
A detection limit of 1 μg/kg (0.001 mg/kg) was considered feasible and supported by Member States during the adoption of the regulation. This limit applies both to migration testing for materials where BPA migration must not be detectable and to testing for residual BPA in materials made using other bisphenols or derivatives. The European Union Reference Laboratory, together with national laboratories, is tasked with further developing and harmonizing testing methods.
Declarations of Compliance and Transitional Periods (Q25 and Q28)
All materials listed in Article 1(2) of the regulation, including multi-material and multi-layer articles, must be accompanied by a DoC, even when BPA has not been used. This obligation also applies during transitional periods following the regulation’s entry into force. Although certain materials placed on the market before that date may lack complete information, compliance efforts and enforcement should take these practical limitations into account during the transition.
Conclusion
The clarifications accompanying Regulation (EU) 2024/3190 provide essential guidance for packaging manufacturers navigating new BPA restrictions. By clearly defining scope, expectations for recycled materials, compliance methods, testing requirements, detection limits and documentation duties, the guidance supports consistent application across the EU while acknowledging practical realities during transitional periods.
