Abstract
The presence of food additives is imperative for the preservation of optimal quality and stability in food products. Nevertheless, concerns regarding their safety persist as a perennial subject of public discourse. In Japan, the 2003 Basic Act on Food Safety established a system whereby the Food Safety Commission (FSCJ) conducts scientific evaluations, and administrative agencies undertake risk management. In 2024, the administration of food hygiene standards was transferred to the Consumer Affairs Agency (CAA), thereby facilitating the integrated management of food labeling and safety control. Designated additives are evaluated based on comprehensive toxicity testing, while existing additives are assessed in line with international standards. For flavorings, the Joint FAO/WHO Meeting on Food Additives (JECFA) and the European Food Safety Authority (EFSA) employ a tiered evaluation approach (TTC concept) using chemical structure and intake information. Japan is conducting reevaluations based on a similar framework. In recent years, new approach methods (NAMs) that do not rely on animal testing have garnered international attention in the safety evaluation of chemicals, including food additives. The NAMs encompass a range of methodologies, including in vitro testing employing microphysiological systems (MPS) and in silico analysis, such as QSAR models and read-across approaches. While regulatory agencies such as the FDA and FSCJ are promoting the introduction and adoption of NAMs, scientific data at the biological level substantiating their health effects remains insufficient. Consequently, animal testing remains an indispensable element in research in this field at present. Nevertheless, progress is being made in the standardization of terminology and the establishment of databases. Concurrent with these efforts, it is anticipated that progress will be made in the establishment of an efficient, internationally harmonized evaluation system that does not rely on animal testing. The safety assessment of food additives, which serves as the foundation linking scientific knowledge, administrative judgment, and societal trust, is expected to continue developing further under international coordination.
