Feature Articles : Regulatory Science in Food Additives
Risk Management × Regulatory Science: The Case of Existing Food Additives
2026 Volume 231 Issue 2 Pages 216-222
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2026 Volume 231 Issue 2 Pages 216-222
Following the 1995 revision of the Food Sanitation Act, Japan introduced the Designated Food Additives system and the Existing Food Additives system for natural food additives. At that time, 489 natural food additives traditionally used were listed in the List of Existing Food Additives, allowing continued use under the new regulatory framework. Over the past thirty years, the system has been refined to ensure safety and quality based on scientific evidence.
Risk management for Existing Food Additives has progressed through two main approaches: deletion of substances posing health risks or no longer distributed, and establishment of compositional specifications to secure quality. Since 2004, five rounds of deletions have removed 162 additives from the list, leaving 327 as of 2025. Among those deleted was "Madder color", which was found to be carcinogenic. Specifications have been established for 260 additives, while 67 remain without standards.
To address additives difficult to obtain, new management policies are being developed. These include adopting industry-developed voluntary standards as reference specifications and introducing simplified standards focusing on raw materials, manufacturing processes, and purity. For enzyme food additives, a strain notification system is also being considered to prevent confusion from changes in microbial scientific names.
Scientific support has advanced through innovations such as the Relative Molar Sensitivity (RMS) method, which enables quantitative analysis without reference standards and has been adopted in the 10th Edition of the Japan's Specifications and Standards for Food Additives. Simplified heavy metal testing using X-ray fluorescence (XRF) and LC-MS-based confirmation of coloring components are currently under consideration and are expected to further improve analytical efficiency and reliability in the future.
After three decades, the Existing Food Additives framework stands at a new turning point. Continued scientific integration, flexible administration, and evidence-based risk management remain vital for maintaining safety, quality, and consumer confidence.
