Newly established regulation in Japan: foods with health claims.

The Japanese government enacted a new regulatory system called 'Foods with health claims' in April 2001, which consists of 'Foods for Specified Health Use' (FOSHU) and 'Foods with Nutrient Function Claims' (FNFC). The FOSHU was set up by the Ministry of Health and Welfare in 1991 to approve descriptions on a label regarding an effect of food on the human body. It was enacted as a part of 'food for specified dietary use' under the Nutrition Improvement Law. There are three important requirements for FOSHU approval. The first is scientific evidence of the efficacy, including clinical testing. The second is safety for consumption. The third is analytical determination of the effective component. At present there are 293 items approved as FOSHU. Most of the descriptions of foods under the FOSHU system are similar to the category of enhanced function claims of Codex. Under FNFC, 12 vitamins (vitamin A, B1, B2, B6, B12, C, E, D, biotin, pantothenic acid, folic acid, and niacin) and two minerals (calcium and iron) are standardized. These claims are similar to the nutrient function claims approved by Codex in 1997. It is desirable that the Japanese administration and the food industry cooperate with ASEAN countries to work together in the development and promotion of nutrition and health claims on foods.