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New Trends in the Revision of EU Food Contact Materials Regulations in 2025

Time：

2025-02-17

The European Commission held a meeting on food contact materials to discuss regulatory revisions, including the addition of permitted substances, mineral oil requirements, bisphenol A ban, etc. Comparing the ban on bisphenol A between the EU and France, adjusting PAA limits and melamine requirements to ensure safety, it is expected to have a significant impact on China's exports.

On February 6-7, 2025, the European Commission's Directorate General for Health and Food Safety (DG SANTE) organized a meeting on Food Contact Materials (FCM) in the European Union to discuss several important regulatory revision plans

(EU) No 10/2011 newly added permitted substances
Revised (EU) No 10/2011 Nickel Migration Limits
New migration limit requirements for mineral oil aromatic hydrocarbons (MOAH)
Promote the ban on bisphenol A
Adjust the requirements for primary aromatic amines and melamine exported from China and Hong Kong, China

(EU) No 10/2011 Revision Plan

1. 9 new substances added to the positive list

Including nano precipitated calcium carbonate, low molecular weight lactic acid, triphenylphosphate ester, etc.

2. Adjustment of nickel migration limit

Plan to adjust the nickel migration limit in Table 1 of Attachment II.

3. New requirement for Aromatic Mineral Oil (MOAH)

Migration limit:
≤ 0.5 mg/kg in simulated substances such as 10% ethanol, 3% acetic acid, MPPO, etc
≤ 2 mg/kg in vegetable oil (if alternative solvents (95% ethanol and iso octane) are used, the limit is the same as 0.5 mg/kg)

(EU) No 2024/3190 Bisphenol A Ban

To evaluate the compatibility between the EU ban on bisphenol A and the current ban in France, the meeting compared the provisions of the two regulations in detail. The results show that the EU ban has a wider scope of application, covering all food contact materials and industrial equipment, not only prohibiting the use of bisphenol A, but also extending to other harmful bisphenol A and its derivatives.

	(EU) No 2024/3190	Regulations 2010-729
Range	All food contact materials, including industrial equipment	Packaging, containers, and utensils containing bisphenol A
Food contact layer	Direct contact layer and indirect contact layer	Direct contact layer
Requirement	Prohibit the use of bisphenol A and other harmful bisphenol and bisphenol derivatives	Do not intentionally add bisphenol A
Limited Requirements	Food contact materials and products made from other bisphenol and bisphenol derivatives (such as BADGE) must not contain any residual bisphenol A	Do not contain bisphenol A
Interim	Transition period of 18-36 months	Implemented
Test Method	Depending on the method chosen by the EU Reference Laboratory (EU-RL)	Extraction method: Extract bisphenol A with 100mL acetonitrile at 23 ° C for 24 hours, with a detection limit of 0.1 mg/kg

▲ Comparison between EU No 2024/3190 and the ban on bisphenol A in France

(EU) No 284/2011 adjusts PAA limit

(EU) No 284/2011 "Specific conditions and detailed procedures for the import of polyamide and melamine plastic kitchen products from China and Hong Kong, China", with planned revisions:

Consistent with (EU) 2017/625:

Update references to other regulations.
Clarify the difference between the "first point of introduction" and the "border control post" (BCP).
Use the Common Health Entry Document (CHED) and the Official Control Information Management System (IMSOC).

Consistent with (EU) No 10/2011:

The migration limit requirements for primary aromatic amines (PAAs) have been updated to be consistent with (EU) No 10/2011. For PAAs listed in Article 43 of Appendix XVII (Appendix 8) of (EC) No 1907/2006, the detection limit for PAAs not specified in Table 1 of Appendix I of (EU) No 10/2011 is 0.002mg/kg. The detection limit for the total migration of aromatic primary amines not listed in Article 43 of Appendix XVII of (EC) No 1907/2006 (Appendix 8) and not specified in Table 1 of Appendix I of (EU) No 10/2011 is 0.01mg/kg.
Update the requirements and testing methods for melamine.

The focus of this meeting is to ensure the safety of food contact materials and to promote the revision and updating of EU regulations on food contact materials. The revised plan involves a wide range of aspects and strict requirements, and is expected to have a significant impact on the export of food contact materials in China. For example, the newly added mineral oil requirements, PAA limit adjustments, and other revised content not only increase the compliance difficulty of Chinese export products, but also bring new challenges to analysis and testing.