Japan Releases Updated Guidelines for Revising Standards for Substances in Food-Contact Materials

Update: On 10 September 2025, Japan’s CAA published the revised manual of standards for substances in FCMs. The information needed for the inclusion of new additives to the PL has been updated in Appendix 1. Information about the substance, physicochemical characteristics, migration to food, safety data, purpose, use, and draft standards are necessary for the addition of new additives. The previous manual which was issued on 28 May 2025 was abolished with this update.

Original Text:

On 28 May 2025, Japan’s Consumer Affairs Agency (CAA) released updated guidelines relating to Food-Contact Materials (FCMs) under the Food Sanitation Act. The CAA published the guidelines on its official portal. This time, the CAA has revised the procedures for:  

1.       Appendix 1 of the Standards for Food, Additives, etc for substances to be added or revised. 

2.       The Monomer Notification, which lists allowable monomers and processing agents in food-contact materials.  

These updates replace the 2020 guidelines and aligns with the end of the Positive List (PL) transitional period on 31 May 2025. The new guidelines are mandatory from 1 June 2025. 

Previous Update in May 2020 

The CAA previously revised the guidelines for FCMs in May 2020. 

Key Insights from the Standards: 

1. Two Types of Revisions: 

• Appendix 1: For substances expected to be widely used.
• Monomer Notification: For additions or changes to monomers and treatment agents. 

2. Procedure: 

• Advance consultation with the Consumer Affairs Agency is required.
• Submit official forms (Form 1 or 2) with supporting documents.
• Safety and migration data must follow Japan's Food Safety Commission 2019 Guidelines.
• A withdrawal form (Form 3) is provided if needed. 

3. Required Documents:  

Substance name, structure, safety data, usage scope, migration test results, and global regulatory status.