井上 隆弘

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.

Abstract: The distribution of HLA‐B17 alleles and their association with HLA‐A, ‐C and ‐DRB1 alleles were investigated in seven East Asian populations (Japanese, South Korean, Chinese‐Korean, Man, Northern Han, Mongolian and Buryat populations). The B17 alleles were identified from genomic DNA using group‐specific polymerase chain reaction (PCR) followed by hybridization with sequence‐specific oligonucleotide probes (SSOP). In all of these East Asian populations, except Japanese and Chinese‐Koreans, B*5701 was detected and strongly associated with A*0101, Cw*0602 and DRB1*0701. In contrast, B*5801 was detected in all the seven populations and strongly associated with A*3303, Cw*0302, DRB1*0301 and DRB1*1302. The A*3303‐Cw*0302‐B*5801‐DRB1*1302 haplotype was observed in South Korean, Chinese‐Korean, Buryat and Japanese populations, while A*3303‐Cw*0302‐B*5801‐DRB1*0301 was predominantly observed in the Mongolian population. A similar haplotype, A*0101‐Cw*0302‐B*5801‐DRB1*1302, was observed in the Buryat population. A novel Cw6 allele, Cw*0604, was identified in the Man population. This Cw allele was observed on the haplotype A*0101‐B*5701‐DRB1*0701. Thus, we confirmed, at the sequence level, that the common haplotypes carrying B*5701 and B*5801 have been conserved and shared in East Asian populations ^Note.