Updated Health Food Registration and Notification Process in China

In China, the concept of “Health Food” encompasses both functional food and dietary supplement. It refers to any food with claimed health beneficial functions or those that can supplement vitamins and minerals, and is intended to be consumed by specific population groups. Health food can modulate body functions, is not aimed to cure any disease, nor expected to cause any harm to the body.

In the New Food Safety Law enacted in October 2015 in China, there is a section addressing food categories other than conventional food, including health food, infant formula and food formulated for specific medical use. It is mandated by the law that a Health Food Function Inventory and a Health Food Ingredient Inventory must be established. To be designated as “health food”, a dual-path procedure was proposed, one being the conventional Health Food Registration process, the more vigorous of the two processes; and the other being the Health Food Notification process, which saves much time for eligible products. In February 2016, the China Food and Drug Administration (CFDA) released rules on the Health Food Registration and Notification processes, effective July 1st 2016. In late May, CFDA asked for public comments on the first draft of Health Food Ingredient Inventory with some vitamins and mineral ingredients included, for the second time.

Below is a synopsis on the registration and notification of health food and requirements from CFDA, with comparisons to the New Dietary Ingredient Notification (NDIN) in the U.S. included.

What is the Health Food Registration process and which department has the authority to regulate?