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Japan Publishes Safety Review Procedures for New Substances under Food Contact Regulation

2025-05-15 Reference source : Consumer Affairs Agency (CAA)-Japan

FCM New substances Regulatory Updates Japan Consumer Safety Positive List


On 14 May 2025, Japan’s Consumer Affairs Agency (CAA) published safety review procedures for new substances used in food contact materials (FCMs) on the portal. These procedures primarily focus on newly approved and applied substances, which are usually listed publicly. A specific application procedure has also been developed to protect the intellectual property (IP) for businesses that are concerned that revealing the names and usage of substances could harm their ability to compete. 

 

Key insights from the Safety Procedures 

  • Added provisions for the safety assessment of new substances and the re-assessment of already approved substances. 

  • A specific procedure has been added to protect intellectual property (IP). 

 

Positive List for Food Contact Materials (FCM) 

The Positive List is currently in a five-year transitional phase that ends on 1 June 2025.  Only substances on the list will be allowed in food contact applications after the transition period.  New materials must be evaluated before being added to the list,.  

 

Guidance for Stakeholders   

In Japan, FCMs are governed by the Food Sanitation Act, and the CAA regularly updates its portal to reflect the latest modifications to standards and specifications for foods and food additives. This document aims to assist manufacturers, importers, and suppliers comply with the safety review process for new substances. Following the procedure helps to prevent non-compliance with FCM supply, import, and manufacturing regulations. 



We acknowledge that the above information has been compiled from Consumer Affairs Agency (CAA)-Japan.

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