Functional food and nutraceutical registration process in Japan and China: Similarities and differences

Abstract

Purpose. This paper looks into the functional food and nutraceutical registration processes in Japan and China. The Japanese have developed the Foods for Specified Health Use (FOSHU) registration process whereas the Chinese have put into place the Health Food (HF) registration process. The aim of this paper is to compare the regulation processes between the two countries. Method. The study was conducted using secondary sources. The literature surveyed covered academic journals, trade journals, magazine and newspaper articles, market reports, proceedings, books and web pages of relevant regulatory authorities and regulatory consultants. Information from the more recently published sources was used over older sources. Indeed Official regulations as well as the Chinese SFDA (State Food and Drug Administration) and the Japanese MHLW (Ministry of Health, Labour and Welfare) websites were also consulted. Results. The two diagrams of the registration processes respectively in Japan and China clearly show that there are similarities and differences. There are six categories under which these can be found: (1) the scientific evidence required; (2) the application process; (3) the evaluation process; (4) the law and the categories of products; (5) the labels and the types of claims; and finally (6) the cost and the time involved. Conclusions. The most noticeable similarity is how the overall process takes place whereas the most noticeable difference is in the number of steps and the structures put into place by each country.