On May 28, 2025, the Food Sanitation Standards Review Division of Japan's Consumer Affairs Agency (CAA) officially issued the Guidelines on the Standards Revision for Substances Contained in Materials of Utensils, Containers, and Packaging, which came into effect on June 1, 2025.
The release of the new guidelines marks the official end of the transition period for Japan's positive list system for food utensils and container packaging, which concluded on May 31, 2025. The guidelines assist in the application process for revisions to Appendix 1 of the Standards for Foods, Additives, etc., clarifying the detailed procedures and requirements. The aim is to provide clear guidance for enterprises applying to include new substances not listed on the positive list within the scope of permission or to modify Appendix 1 or monomers etc., as notified.
Enterprises need to apply for one of the following two types of revisions based on the nature and use of the new substance:
- Application for revision of Appendix 1 of the Standards for Foods, Additives, etc.
Applicable to: New base materials expected to be widely used and suitable for setting unified standards in Appendix 1.
- Application for revision of monomers etc., notified in Appendix 1, Attachments 1-21
Applicable to: Cases where new monomers are added or used beyond the existing scope of the existing regulations, including necessary monomers, optional substances, necessary chemical treatments, and optional chemical treatments.
Application Process
- Preliminary consultation: Applicants need to consult with the Food Sanitation Standards Review Division in advance about the type of application and required documents, and prepare materials according to the guidelines.
- Submission of application materials: Submit application documents and attachments in the specified format 1 or 2 to the Food Sanitation Standards Review Division.
- Review: The Review Division evaluates the materials, consults the opinions of the Food Sanitation Standards Deliberation Council and the Food Safety Commission, and decides whether to revise.
- Withdrawal: Applicants may submit a withdrawal request notification using format 3 at any time.
Key Requirements for Submission (Six Categories)
- Reason for the application
- Knowledge about the target substance (name, structure, physicochemical properties, purity, impurities, etc.)
- Purpose and scope of use (purpose, effect, conditions of use, domestic and international usage status, etc.)
- Proposals for specifications
- Knowledge about the migration of the substance into food (leaching test conditions and results, calculation of concentration in food, etc.)
- Knowledge about safety
The new guidelines and their attachments further detail the specific data content required for different types of applications. Enterprises must follow the requirements of the new guidelines to apply for regulatory approval for the use of new substances in food contact materials.
Further Information
