I n China there are two categories of health food:

I. Nutrition supplement (vitamin and (or) mineral supplement)

II. Functional health food

What Is the Nutriti on Supplement in China?

In accordance with “ Provisions on the Application & Approval for Nutrition Supplement (Trial) (Notice No.[2005]202) ”, the definition of nutrition supplement is:

Nutrition supplement is the product that replenishes the vitamins and (or) minerals but without providing energy.

Current Legislations of Nutrition Supplement in China

Under the current regulatory framework, companies who plan to place nutrition supplement in Chinese market must apply for and obtain a health food approval certificate from China Food and Drug Administration (CFDA). Foreign companies shall appoint a Chinese agent to deal with registration and obtain such certificate.

The current main regulations regarding nutrition supplement are listed as follows.

NO.	Regulations	Publish Authority	Release Date
Registration Regulations
1	Administrative Measure on Health Food Registration (Trial) (Order No.19)	CFDA	2005-4-30
2	Provisions on the Application & Approval for Nutrition Supplement (Trial) (Notice No. [2005]202)	CFDA	2005-5-20
Test Regulations
1	Guideline on Stability Test of Health Food	CFDA	2013-12-02
Label Regulations
1	Notice on Provisions and Guidance for the Naming of Health Food (Notice No.[2012]78)	CFDA	2012-3-15
2	Rules on the Labeling of Health Food (NO.(1996)38)	MOH	1996-7-18
Other Relevant Laws and Regulations
1	Examination method and evaluation criterion on GMP of health food (NO.[2003]77)	MOH	2003-4-2
2	GB 16740-2014 National Standard Health Food	NHFPC	2014-12-24
3	GB2760-2014 Food Safety National Standards for the Usage of Food Additives	NHFPC	2014-12-24
4	Advertisement Law (Order No.22)	President of the People’s Public of China	2015-4-24
5	Food Safety Law (Order No.21)	President of the People’s Public of China	2015-4-24
6	Administrative Measure of Food Production License	CFDA	2015-8-31
7	Administrative Measures of Food Operation License	CFDA	2015-8-31
8	Administrative Measures of Food Recall	CFDA	2015-3-11

Future Legislations of Nutrition Supplement in China

The regulatory framework pertaining to the nutrition supplement is changing significantly recently. Some general updated laws and regulations were released and implemented in 2015. According to the new Food Safety Law, if the nutrition supplements meet the requirements, companies who plan to place them in Chinese market only need to filing (record) the product instead of applying for the registration certificate.

The drafted main regulations regarding nutrition supplement are listed as follows.

NO.	Regulations	Publish Authority	Release Date
Registration Regulations
1	Administrative Measures of Health Food Registration and Filing (Draft)	CFDA	2015-7-28
2	Administrative Measures on Health Food Function Directory and Health Food Raw Materials Directory (Draft)	CFDA	2015-7-28
3	Nutrition Supplement Raw Materials Directory (Draft)	CFDA	2016-02-17
Label regulations
1	Administrative Measures on the Labeling of Health Food (Draft)	CFDA	2015-7-28
Other Relevant Laws and Regulations
1	Supervision and Administrative Measures of Food Commerce in Network(Draft)	CFDA	2015-8-18
2	Supervision and Management on Cross-Border Electronic Commerce of Imported Food through Bonded Online Shopping (Draft)	AQSIQ	2015-10-13

What Kind of Health Food Could Apply for the Filing Certificate?

I. The domestic functional health food of which the raw materials meet the requirements in the Health Food Raw Materials Directory.
II. The domestic and imported nutrition supplement of which the vitamins and (or) minerals meet the requirements in the Health Food Raw Materials Directory.

Therefore, “Health Food Raw Materials Directory” is the most important condition to judge if the health food is in the filing (record) scope.

With the focus of the directory, China Food and Drug Administration (CFDA) released the first batch of approved Health Food Raw Materials Directory (Draft) (EN version free download) on February 17, 2016. However, the first batch of the drafted directory is only applicable to the nutrition supplement. Compared with the requirements of “ Provisions on the Application & Approval for Nutrition Supplement (Trial)”, the approved vitamin & mineral category, approved compounds, daily intake and other requirements of the first batch drafted directory are changed.

Some examples of the main changes are collected as following:

Matters Needing Attention for Filing Nutrition Supplements

If manufacturers would like to record (filing) the nutrition supplements, the raw materials, product dosage form, daily intake, quality standards, product labeling shall conform to the requirements of the first batch raw material directory.

The Advantages and Disadvantages of Record (Filing) Policy

Oversea enterprise who would like to save the money and time for putting nutrition supplement in Chinese market is suggested to wait for the filing policy to come into force. However, in order to sell original and more competitive products in China, enterprise is advised to register the nutrition supplement that is demanded in the Chinese market. In addition, two-pronged strategy for nutrition supplement is also recommended.
With the regard to the procedures of the health food record (filing), ple ase kindly click below link for further information.

Our Services

CIRS Initially set up by China Inspection and Quarantine (CIQ) Bureau in 2007 and now has grown to be a leading provider of comprehensive compliance services for companies doing businesses in/with China. We provide one-stop solutions to your regulatory issues in China. We also deliver the most up-to-date regulatory information about food safety control laws in China. For health food, we offer the following service:

• Pre-market Investigation of Health Food

• Classification Analysis and Regulatory Compliance Review

• Domestic/Imported Health Food Registration

• Domestic/Imported Health Food Record (filing)

• Approval of Entering Health Food Raw Materials Directory

• Approval of Entering Health Food Function Directory

• New Food Raw Material Approval

• Consulting Services of Health Food

• Tests for health food registration and filing

• Training on health food legislation in China

• Regulation update