Revised Guidelines for the Risk Assessment of Food Additives in Japan

In September 2021, the Food Safety Commission of Japan (FSCJ) revised its 2010 guidelines for the risk assessment of food additives. The revised guidelines, titled Guidelines for the Risk Assessment of Food Additives, incorporate updated international trends in toxicity testing and reflect the experience gained from prior assessments. The revised guidelines are composed of the following 4 chapters: Chapter 1. General Provisions; Chapter 2. Detailed Exposition; Chapter 3. Approach for the risk assessment of processing aids; and Chapter 4. Approach for the risk assessment of additives in foods used as breast milk substitutes for infants under four months old. A central feature of the revised guidelines is the organization of risk assessment into four distinct steps: hazard identification, hazard characterization (toxicological assessment), exposure assessment, and risk characterization. These steps, based on the Codex Alimentarius principles, ensure a thorough and systematic evaluation of food additives. The guidelines also introduce the Threshold of Toxicological Concern (TTC) approach for processing aids and guideline for assessing the additives used as breast milk substitutes for infants under four months old, considering their specific characteristics. This paper provides an overview of these key updates, and offer a structured approach to enhance transparency and consistency risk assessment practices for food additives in Japan.