|
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 explicitly applies to materials such as plastics, varnishes and coatings, printing inks, adhesives, silicones, rubber, etc. External parts of FCMs (Food Contact Materials) are covered if they may transfer constituents to food under normal or foreseeable conditions of use. Notably, the entire chain—from raw materials and intermediate materials and final articles—is covered.
- 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
- Bisphenol A and its salts shall not be used in food contact materials and articles. However, exemptions for the use of bisphenol A are permitted under Annex II.
FCM substance
No |
CAS NO |
Substance name |
Material type |
Specific application |
Other restrictions |
| 151 |
80-05-7 |
4,4'-isopropyli
denediphenol
(bisphenol A) |
Varnishes and coatings |
For use as a monomer or starting substance in the manufacture of liquid epoxy resins to be applied on self-supporting food contact materials or articles with a capacity greater than 1 000 litres |
Migration into food shall not be detectable. Final food contact articles shall be cleaned and flushed prior to first being brought into contact with food |
| Plastics |
For use as a monomer or starting substance in the manufacture of polysulfone filtration membrane assemblies |
Migration into food shall not be detectable. Final food contact articles shall be cleaned and flushed prior to first being brought into contact with food |
- 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:
| Substance name |
CAS number |
Relevant classification in table 3, Annex VI to
Regulation (EC) No 1272/2008 |
| Bisphenol S (BPS) |
80-09-1 |
Repr. 1B |
| 4,4'-Isobutylidenediphenol |
6807-17-6 |
Repr. 1B |
| Phenolphthalein |
77-09-8 |
Carc. 1B |
| Bisphenol AF (BPAF) |
1478-61-1 |
Repr. 1B |
| Tetrabromobisphenol-A (TBBPA) |
79-94-7 |
Carc. 1B |
It can also be noted that, at the time of the adoption of this guidance, an ECHA RAC opinion was published on 17 September 2024 concerning a proposed harmonized classification (Repro. 1B) for bisphenol F (4,4'-methylene-diphenol) (CAS no. 620-92-8).
Although Regulation (EU) 2024/3190 defines ‘hazardous bisphenols’ and ‘hazardous bisphenol derivatives’ in relation to the harmonized classification under Regulation (EC) No 1272/2008, in determining the safety and suitability of alternatives, business operators may wish to take into account ongoing developments as regards new scientific information and steps taken in the classification process, including proposals under Regulation (EC) No 1272/2008 and self-classification.
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.
- Regulation (EU) 2024/3190 does not make it obligatory to undertake analytical testing. However, the business operator must ensure contain prohibited hazardous bisphenols and derivatives. Testing may be used to verify compliance, particularly for Annex II applications or when using BPA derivative
| Substance |
CAS Number |
CMR 1A or 1B or Endocrine disrupting
for human health Category 1 (ED HH1) |
| Bisphenol A |
80-05-7 |
Repr.1B |
| Bisphenol S |
80-09-1 |
Repr.1B |
| Bisphenol AF |
1478-61-1 |
Repr.1B |
| 4,4-isobutylethylidenediphenol |
6807-17-6 |
Repr.1B |
| Tetrabromobisphenol A |
79-94-7 |
Carc.1B |
| Phenolphthalein |
77-09-8 |
Carc.1B |
| Bisphenol F |
620-92-8 |
Not currently classified (proposal under review) |
Intertek provides comprehensive testing services for multiple bisphenol substances (including but not limited to above table), with capabilities for both content analysis and migration testing at the regulatory detection limit of 1 μg/kg. These services support enterprises in risk assessment and compliance with updated EU food contact material requirements.
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.
Import & Export Requirements
- Export Requirements：Articles intended for contact with food in a third country market are not considered within the scope of EU FCM rules. Operators must ensure proper documentation to prevent diversion to the EU market.
- Import Requirements：All FCMs placed on the EU market, regardless of origin, must fully comply with all requirements of this Regulation (e.g., BPA ban, residual limits, DOC); Importers wishing to use hazardous bisphenols (other than BPA) or derivatives must also comply with the Article 5 prohibition and may apply for authorization under Article 6; The deadlines for transitional periods for imported final articles are identical to those for EU-produced goods.
Transitional Provisions
- The document specifies the transition period deadlines for the following products:
| FCMs |
Date first placed on EU market |
Date of inventory depletion |
| Single-use final food contact articles (e.g. metal packaging such as a can) |
By 20 July 2026 (Can no longer be first placed on EU market. Unfilled packaging may remain on the market for 1 year for filling with food.) |
By 20 July 2027 (Any unfilled packaging must have been filled with foodstuffs and sealed) |
| Single-use final food contact articles for preservation of fruits, vegetables and fishery products or where a varnish or coating manufactured using BPA has only been applied to the exterior metal surface |
By 20 January 2028 (Can no longer be first placed on EU market. Unfilled packaging can remain on the market for 1 year for filling with food) |
By 20 January 2029 (Any unfilled packaging must have been filled with foodstuffs and sealed) |
| Repeat-use final food contact articles (e.g. kitchenware such as drinks bottles) |
By 20 July 2026 (Can no longer be first placed on EU market) |
By 20 July 2027 (Can no longer be placed on EU market) |
| Repeat-use final food contact articles used as professional food production equipment |
By 20 January 2028 (Can no longer be first placed on EU market) |
By 20 January 2029 (Can no longer be placed on EU market) |
Recommendations for Businesses
- Supply Chain Review: Immediately review your supply chain to identify any use of BPA or related bisphenols in food contact materials.
- DOC Management System: Establish a robust DOC management system to ensure traceability and compliance throughout the supply chain.
- Monitor Regulatory Updates: Stay informed about ECHA/EFSA updates, particularly regarding classification of bisphenols like BPF.
- Formulation Adjustment: Consider reformulating products to eliminate prohibited bisphenols and explore safer alternatives.
- Compliance Testing: Conduct appropriate testing to verify migration levels and absence of residual BPA, especially for Annex II applications.
- Transition Planning: Plan production and inventory management according to the transitional deadlines to avoid market disruption.
Contact Windows
Hotline：0755-2602 0287
Susie.su@intertek.com
Content you may be interested in:
ASTM Published Latest Safety Standard for Infant and Cradle Swings ASTM F2088-25
|
