The Use of Novel Food Material in Health Food

When it comes to food, the definition in the Chinese Food Safety Law refers to both raw materials and finished products for human consumption. It is worth

The Regulation of “Novel Food” in China 141 mentioning that the legal definition of food also includes articles that are tradi­tionally used in food and medicine due to the fact that food therapy and dietary regime are important elements in Chinese traditional medicine, under which the former is for curing diagnosed diseases with functional food like certain herbals and the latter for promoting health and longevity.^[528] Therefore, to keep up this tradition for promoting health, a list of the materials that can commonly be used in food and medicine has been established by the health department.^[529] In China, food that has the function to promote health, like dietary supple­ments in the United States or functional food in Japan, is called “health food.” According to the Measure on Heath Food in 1996,^[530] health food should be approved on the basis of safety assessment and evidence of its effectiveness, while follow-up review is possible if monitoring shows changes in the function regarding an approved health food.

As far as the linkage between novel food material and health food is con­cerned, it is allowed to use new food material in health food if it has the func­tion to offer a beneficial health effect.

can be said that labeling in the form of a health claim was an important tool at that time to tell the difference between novel food and health food.

In view of this, it is important to figure out the difference between and linkage of the following lists regarding what can or cannot be used in food products, including:

• List of the materials that can be commonly used in food and medicine

• List of the materials that can be used in health food

• List of the materials that cannot be used in health food

• List/catalogue of novel food material

These lists can be updated to include new materials according to the applica­tion. Among them, the first, second, and fourth lists are set up in the form of positive lists, while the third one is a negative list. Accordingly, the materials from the first list can be used in conventional food, but materials only used in medicine may not be used in any kinds of food. As indicated by the name, the materials from the second list are only for health food, while the third one includes materials that are forbidden for health food. Notably, if the materi­als from the second one are intended to be used in conventional food, first approval as novel food material is required. For the fourth list, the approval for this kind of material only considers the safety, not the effectiveness. Therefore, to avoid duplication of administrative work, the health department has con­firmed that the regulation of novel food material is to exclude the review of material that is only used for health food. That is to say, even if the material can be regarded as novel according to the Measures on the Safety Review of Novel Food Material, the use only in health food can exempt it from approval required by this rule.

IV.