ABSTRACT

The proportion of senior citizens in relation to the general population is rapidly increasing in developed countries, especially in Japan. With the rapid increase in the number of elderly people and the development of a senior society, chronic diseases such as diabetes, cardiovascular diseases, hypertension, osteoporosis, and cancer are expected to increase. Systematic research on the health benets of foods started in Japan in 1984. The Japanese Ministry of Education started a project concerning food functionality. The project rst dened the concept of functional food; that is, foods have three functions: The primary function is a nutritional function, which is essential to human survival. The secondary function is a sensory function involving both avor and texture to satisfy the sensory needs. The tertiary function is a physiological function such as regulation of biorhythms, control of aging, the immune system, and body defense beyond nutrient functions. The project dened a functional food as a food having a tertiary function. The project has identied many food components having a tertiary function, and scientic evidence is accumulating regarding the study of the

16.1 Introduction ........................................................................................................................ 217 16.2 Health Claims Regulation ................................................................................................... 218

16.2.1 Codex Alimentarius .............................................................................................. 218 16.2.2 Japanese Regulatory System ................................................................................. 218

16.2.2.1 Foods for Specied Health Use ........................................................... 218 16.2.2.2 Food with Nutrient Function Claims ................................................... 221

16.2.3 The United States .................................................................................................. 222 16.2.4 The European Union ............................................................................................. 222 16.2.5 People’s Republic of China ................................................................................... 223 16.2.6 Australia and New Zealand ................................................................................... 223

16.3 International Comparison of Scientic Substantiation ....................................................... 223 16.4 International Comparison of Regulatory Systems ..............................................................224