On December 17, 2025, the European Union Published the Guidance C/2025/6721 on the implementation of Regulations (EU) 2024/3190. This document explains the scope of Regulations (EU) 2024/3190, regulated substances, compliance and testing, import/export requirements, and transitional provisions in a Q&A format.
The following are the key points of this document:
• Scope
The Regulation does not include paper and paperboard (unless combined with the applicable materials listed above), enamel, and recycled materials (As BPA is not used intentionally in such manufacturing processes and such contamination cannot be fully controlled, recycled FCMs are not within the scope). Additionally, materials in contact with pet food are not covered.
• Regulated Substances
- BPA derivatives such as BADGE (CAS No 1675-54-3) are not specifically banned. However, compliance with Article 4 is required, meaning no residual BPA can be present in the final FCMs.
- Besides BPA, any bisphenol/bisphenol derivative with a harmonized classification as CMR 1A/1B or ED 1 under (EC) No 1272/2008 is banned. This document is summarized as follows:
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• Compliance and Testing
- Verifying that migration is below the detection limit (1 µg/kg) when BPA is used under Annex II.
- Verifying absence of residual BPA (LOD:1µg/kg) when other bisphenols / derivatives are used.
• Declaration of Compliance (DOC)
- All materials within the scope of Article 1(2) (including multi-material articles) must be accompanied by a DOC even if no BPA was used.
- The DOC must contain a list of all bisphenols and bisphenol derivatives used in the manufacture of the FCM, not only hazardous ones.
- All operators except retailers (manufacturers, processors, importers) are responsible for providing and delivering the DOC. It can be integrated into a single document with requirements from other regulations (e.g., (EU) 10/2011).
- The DOC must still be issued during the transitional periods to ensure restrictions are met and help manage stocks in the supply chain.
• Transitional Provisions
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URL:
https://eur-lex.europa.eu/eli/C/2025/6721/oj/eng
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