Note for Guidance on the implementation of Commission Regulation (EU) 2024/3190
on the use of bisphenol A (BPA) and other bisphenols and bisphenol derivatives with harmonised classification for specific hazardous properties in certain materials and articles intended to come into contact with food
Document number: C/2025/6721
Date: 17th Dec, 2025
CONTENTS
- SCOPE OF COMMISSION REGULATION (EU) 2024/3190
- OTHER BISPHENOLS AND BISPHENOL DERIVATIVES
- COMPLIANCE AND TESTING
- PLACING ON THE MARKET
- TRANSITIONAL PROVISIONS
A total of 40 questions are clarified. The full answers to these 40 questions can be accessed at:
https://eur-lex.europa.eu/eli/C/2025/6721/oj/eng/pdf
https://eur-lex.europa.eu/eli/C/2025/6721/oj/eng
Q1. Is paper and board within the scope of the ban?
Q2. Are recycled FCMs within the scope of Regulation (EU) 2024/3190?
Q3. Is enamel to be regarded as a coating and therefore as falling under the scope of Regulation (EU) 2024/3190?
Q4. Are external parts of FCMs within the scope of Regulation (EU) 2024/3190?
Q5. Why does Regulation (EU) 2024/3190 sometimes refer to food contact materials and articles, but also to ‘intermediate food contact materials’ and ‘final food contact articles’? What is the difference?
Q6. Are there any examples of ‘intermediate food contact materials’ as opposed to ‘final food contact articles’?
Q7. Does Regulation (EU) 2024/3190 cover materials and articles in contact with pet food?
Q8. Are pipes belonging to or connected with self-supporting materials covered by the derogation related to self-supporting materials laid down in Annex II to Regulation (EU) 2024/3190?
Q9. Are BPA derivatives banned in Regulation (EU) 2024/3190?
Q10. In that case, why is there a need for the derogations in Annex II of Regulation (EU) 2024/3190?
Q11. What about other bisphenols that may be used as substitutes for BPA, which may have similar hazardous properties?
Q12. If business operators need to use other hazardous bisphenols, including bisphenol S (BPS), in the manufacture of their FCMs, how can they demonstrate that there is no risk?
Q13. What happens until EFSA publishes the guidance concerning the information necessary for the assessment of hazardous bisphenols or hazardous bisphenol derivatives?
Q14. What happens after EFSA has published the guidance concerning the information necessary for risk assessing hazardous bisphenols?
Q15. What happens if a relevant harmonised classification applies to a bisphenol or a bisphenol derivative in the future, after EFSA publishes its guidance?
Q16. From when is a hazardous bisphenol classified as such?
Q17. What are the other bisphenols and bisphenol derivatives currently considered as hazardous and falling within the scope of Article 5?
Q18. Which bisphenols and bisphenol derivatives must be listed in a Declaration of Compliance (DoC) pursuant to Article 8 and in Annex III, point 5 of Regulation (EU) 2024/3190?
Q19. What information concerning the status of alternative substances referred to in Article 7(1) of Regulation (EU) 2024/3190 should business operators submit?
Q20. How can compliance with Regulation (EU) 2024/3190 be demonstrated?
Q21. Is it obligatory to prove the absence of BPA with laboratory analysis?
Q22. Is the detection limit of 1 μg/kg (1 ppb or 0,001 mg/kg) feasible and practical for compliance and enforcement purposes?
Q23. Does this detection limit apply for migration or for residual content?
Q24. Does the limit of detection apply to BPA as a ‘non-intentionally added substance’ (‘NIAS’) or as a contaminant?
Q25. Is there an obligation to issue a Declaration of Compliance (DoC) for all FCMs within the scope of Regulation (EU) 2024/3190, even if no BPA has been used?
Q26. Whose responsibility is it to issue the DoC?
Q27. Is more than one DoC needed if the FCM falls within the scope of other specific Union rules?
Q28. Is there an obligation to issue a DoC during the transitional periods, i.e. from the date Regulation (EU) 2024/3190 enters into force?
Q29. Can FCMs manufactured with BPA be exported to third countries?
Q30. What about imported FCMs from third countries?
Q31. What about BPA which may be present in food which does not originate from FCMs placed on the Union market, like food production equipment used in a third country? Or BPA that may already be in the food, for example as a result of environmental contaminant?
Q32. From the perspective of a business operator, which is the relevant transitional period for placing a food contact article on the Union market?
Q33. Do the transitional provisions apply also for “intermediate materials” such as varnishes and coatings or plastic resins?
Q34. Can the final food contact article then remain on the Union market, or do they need to be removed from sale?
Q35. What is considered as ‘professional food production equipment’?
Q36. What about single-use food contact articles for which a 36-month period is allowed but are also filled with other foodstuffs, e.g. cans containing both fish and pasta?
Q37. What about the transitional periods for imported FCMs?
Q38. Are there any transitional measures provided for Article 4 on the presence of residual BPA?
Q39. Will there be any transitional periods applicable for other hazardous bisphenols and derivatives?
Q40. Would it be possible to include a timeline as a visual presentation on the different transitional periods/application dates?