[Brief Introduction of Seminar]
The Japanese Foods with Function Claims (FFC) system, introduced in 2015, has entered a new phase following major regulatory revisions in 2024–2026 — including mandatory health-hazard reporting, mandatory GMP compliance, extended review periods for new ingredients, and mandatory annual self-inspection. This session reviews these latest regulatory developments and examines the fundamental institutional differences between Korea's government-approved individual-recognition system and Japan's company-responsibility notification system — a distinction Korean health functional food companies must understand before entering the Japanese market. Building on this foundation, the session addresses the practical steps required for successful entry, including defining the functional ingredient, establishing a publication and systematic review (SR) strategy, and designing the notifier structure. It further walks through the full FFC notification process step by step — from product selection and ingredient confirmation through evidence-building, publication, notification, and sales, to post-market management such as health-hazard response, self-inspection, and change management — while highlighting common points Korean companies tend to overlook during market entry, in order to offer more practical preparation strategies.
[Brief Introduction of Speaker]
Dr. Ohnuki graduated from the Faculty of Agriculture, Kyoto University (1994–1998), and completed his graduate studies at the Graduate School of Agriculture, Kyoto University (1998–2002). He worked as a researcher at the Otsuka Pharmaceutical Nutraceuticals Research Institute (2002–2004), followed by a position as Specially Appointed Assistant Professor at the Graduate School of Medicine, Kyoto University (2004–2005). He later served as Professor at the Institute of User Science, Kyushu University (2005–2009) and Professor at the Faculty of Plant Nutrition, Kyushu Nutrition Welfare University (2009–2013). He then held positions as Associate Professor (2013–2019) and Professor (until March 2024) at Kindai University, where he currently serves as a part-time professor (since April 2024). He also served as a Visiting Professor at Kyushu University (2021–2023). He has authored or co-authored more than 200 academic papers and published several books on Foods with Function Claims (FFC). With hands-on experience in more than 50 FFC notification and research projects, he is a recognized practitioner in the field, and continues to serve as an advisor and consultant for numerous companies. He has also appeared on television and delivered numerous invited lectures.