Abstract
The food additive designation system in Japan began with the promulgation of the Food Sanitation Act in 1947. In response to the subsequent increase in requests for new designations from both within and outside Japan, the Food Additive Designation Consultation Center (FADCC), established at the National Institute of Health Sciences in 2014, has been providing expert advice on how to prepare application documents(e.g., application form and overview document)before designation. While the consultation by FADCC has functioned smoothly, in response to the increasing transparency of systems overseas and the revision of the Food Safety Commission of Japan's "Guidelines for the Risk Assessment of Food Additives", FADCC introduced a stage-gate system with checklists that designation requestors can use to confirm their application documents preparation status, providing scientific clarity regarding visibility and foreseeability for the application process. FADCC also developed and published on its website a "Handbook for the Procedure" that designation requestors can use to prepare an appropriate overview document. These information disclosures, along with the updated "The Procedure for Preparing Application Documents for Designation of Food Additives and Revision of Use Standards for Food Additives", further deepens the fairness and transparency of the food additive regulations in Japan.
