China Health Food Registration and Filing

In China, health food is usually defined as food products that have specific health functions or supply vitamins and (or) minerals. With the goal of regulating the body's function, health food is suitable for specific groups of people. However, it is not used for the purpose of curing disease and causes no acute, sub-acute or chronic health effect to human body.

The Definitions/Names of these Food Products in Different Countries are Different:

• China: Health Food
• EU: Food Supplement
• USA: Dietary Supplement
• Canada: Natural Health Product
• Australia: Complementary Medicines
• Korea: Health Functional Food
• Japan: Food with Health Claims (FHC)

Classification of Health Food

I. Nutrition supplement:

Food that replenishes vitamins, minerals and other nutrients but without providing energy or other active ingredients.

II. Functional health food:

Food that labeled with health function claim to have physiological effects on the human body.

Regulation Background

In accordance with Food Safety Law of the People’s Republic of China (2015 version), companies who plan to place health food in the Chinese market shall apply for and obtain the health food registration certificate or filing certificate. For domestic health foods produced in China, the registration shall be conducted with the State Administration for Market Regulation (SAMR, former CFDA), whereas, the filing shall be carried out with the Provincial Administration for Market Regulation. For imported health foods produced in overseas factories, both the registration and filing shall be applied with SAMR. Meanwhile, overseas companies shall have a permanent Chinese representative office or appoint a Chinese agent to deal with registration or filing and obtain such certificates.

News Updates

In accordance with the announcement of the State Administration for Market Regulation (SAMR) regarding the release of Directory of Health Functions Available to Be Claimed by Health Food - Non-nutrition Supplements (2023 Version) and the supporting documents, registrants need to change their health food registration certificates to revise the wording of their health claims, so as to align the latest wording and evaluation requirements when the health functions are listed in the Directory yet the wording of the health claims is outdated (e.g., regulating immunity or improving sleep).

Relevant Regulations on Health Food

Name

Released Date

Implemented Date

Food Safety Law of the People's Republic of China (2021 Revised Version)

2015.04.24 (Revised on 2021.04.29)

2016.02.26 (Revised on 2020.11.03)