Author: Amanda Mao, PhD
Published: 13 November 2020
A crucial regulation for the supplement industry, Administrative Measures on Registration and Notification of Health Food (link in Chinese) was revised and has been effective since 3 Nov 2020 in China.
Here AMC compiles its important sections in English, especially where overseas health food companies are concerned.
We also provide expert interpretation and future directions in the end.
China Health Food Regulation Overview
Health food in China roughly equals to health supplement, dietary supplement, or complementary medicine in the West. It is a literal translation from the corresponding Chinese term “保健食品”(Bao Jian Shi Pin).
Health food registration refers to the vetting and approval process where the market supervision and administration agency evaluates the health food application materials including safety, health function and quality controllability. The agency will decide whether to grant registration according to statutory procedures and requirements.
Health food notification refers to the process where a health food manufacturer submits to the market supervision and administration agency materials indicating safety, health function and quality controllability of the product. This is for filing, disclosure and future reference according to statutory procedures and requirements.
The State Administration for Market Regulation (SAMR) is responsible for health food registration as well as notification of first-time imported health food belonging to the Vitamin and Mineral Supplement category. The SAMR shall also guide health food registration and notification related tasks undertaken by provincial departments for market regulation.
Provincial departments for market regulation is responsible for health food notification within their respective administrative region, and working with the SAMR to carry out on-site audits of health food applying for registration.
Municipality- and county-level departments for market regulation shall supervise and manage health food products that have achieved registration and notification status within their administrative region.
China Health Food Registration
Companies manufacturing and importing the products below shall apply for health food registration.
- Health food using raw materials other than those listed on the Health Food Raw Material List (Off-List Raw Materials)
- Except for Vitamin and Mineral Supplements, health food imported for the first time
Also, the health function claimed by a product shall already be included in the Health Food Function List.
The following critical materials shall be submitted when applying for health food registration:
- Health food registration application form
- Applicant’s company registration certificate
- R&D report, including literature evidence of safety and function of the finished product and raw materials
- Product formula materials
- Product manufacturing and process materials
- Assessment materials on safety and health function. And others (omitted for simplicity)
The following additional materials shall be submitted when applying for registration of imported health food for the first time:
- Certificate issued by the government department or legal service agency from the product manufacturing country/region that the applicant is an overseas manufacturer of a health supplement on the market.
- A certificate that the health supplement has been on the market for more than a year, or a safety report demonstrating overseas sales and consumption. They shall be issued by the government department or legal service agency from the product manufacturing country/region
- Health food technical regulations or standards in the manufacturing country/region or international organization(s)
- Package, labelling and specifications of the on-the-market product in the manufacturing country/region
SAMR-qualified food inspection institutions conduct testing and inspection of health food.
A health food registration certificate is valid for five years.
The format of a registration number for domestic health food is Guo Shi Jian Zhu (four Chinese characters), followed by the letter G, 4-digit year, and finally, 4-digit serial number. The format of a registration number for imported health food is Guo Shi Jian Zhu (four Chinese characters), followed by the letter J, 4-digit year, and finally, 4-digit serial number.
The only difference is for the former, the English letter is G, and the latter, J.
China Health Food Notification
Companies manufacturing and importing the products below shall apply for health food notification:
- Health food using raw materials listed in the Health Food Raw Material List
- Vitamin and Mineral Supplements imported for the first time. Here the nutrients shall already be included in the Health Food Raw Material List.
The format of a notification number for domestic health food is Shi Jian Bei (three Chinese characters), followed by the letter G, 4-digit year, 2- digit provincial administrative district code, and finally, 6-digit serial number. The format of a notification number for imported health food is Shi Jian Bei (three Chinese characters), followed by the letter J, 4-digit year, double zero, and finally, 6-digit serial number.
China Health Food Labels and Specifications
Health food labels and specifications shall not involve disease prevention and treatment. State “This product cannot replace a drug”.
Health food names shall not contain:
- Words that are false, exaggerated, or absolute
- Words that express or imply prevention or treatment of diseases
- Vulgar or superstitious words
- Words describing human tissues and organs
- Symbols other than quotation marks (“)
- Other misleading words to consumers.
Interpretation and Future Implications
We chatted with a China-based regulatory consultant Jing Yu for her expert opinion. The key points we covered are:
Updates in Nov 2020
- Administrative update on the names of relevant government departments and agencies.
Important updates since 2016
- Health food shall achieve registration or notification status to be sold in retail stores in China.
- China practices dual management for health food using registration and notification pathways. Previously, there was only the registration pathway. The addition of the notification pathway provides more flexibility, efficiency, and choices for the health food industry both in and outside of China. If a product has notifiable health food functions and its raw materials are included in the notifiable health food raw material list, notification scheme applies; otherwise, registration.
- Requirements for registration and notification materials are more explicit and rigorous.
- Imported health food shall always file with the SAMR, regardless of registration or notification; domestic health food shall file with the SAMR for registration and a provincial department for market regulation for notification.
- Currently, only health food with nutrient(s) on the list of 22 vitamins and minerals are eligible for notification. The list will continue to expand. For domestic health food, hopefully, five functional ingredients – melatonin, coenzyme Q10, fish oil, spirulina and ganoderma spore powder – will be added to the notification scheme soon (link in Chinese).
- Moving forward, for registration for imported health food, on-site audits may be required for overseas health food manufacturers based on relevant China GMP. It seems that health food registration for overseas manufacturers still has a long and bumpy road ahead. On a brighter side, 32 imported health food products achieved notification status in China between Jan and Jun 2020.
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