FAQs on Health Food Registration and Filing in China

We’ve translated a selection of some of the latest FAQs on health food registration and filing in China to help you understand the current requirements.

Q: Can health food currently be declared?

A: Health food filing: can be declared.

Currently, two types of health food products shall apply for and obtain a filing certificate.

(1) Nutrient supplements (vitamins, minerals, and other nutrient supplements).

(2) Functional health food (functional health food with Coenzyme Q10, melatonin, Spirulina, Broken Ganoderma lucidum spore powder, and fish oil as single raw material.) Currently, filing of functional health food is only suitable for domestic health food.

Health food registration:

Since the repeal of Technical Standards for Testing & Assessment of Health Food (2003 Edition) in 2018, most of the registrations of new health food products in China have been suspended due to a lack of testing basis for functional evaluation.

However, according to 国食药监保化[2012] No. 107 (National Food and Drug Administration [2012] No. 107), nine health function evaluation methods are currently valid, these are:

• antioxidant;
• assisting the protection from gastric mucosal injury;
• assisting blood sugar reduction;
• alleviating visual fatigue;
• improving iron-deficiency anemia;
• assisting blood lipids reduction;
• alleviating lead excretion;
• reducing body weight; and
• clearing and nourishing the throat.

Moreover, several new regulations on evaluation methods of health food functions were issued for public comments on November 24, 2020, and January 13, 2022. We believe that the new evaluation methods can be implemented in the very near future, and products with the 24 permitted health functions can be registered smoothly.

Q: What are the differences between health food registration and filing?

A: The differences between registration and filing of health food can be separated into several parts, including the scope and process of application, requirements for tests, and dossiers. (Click here to view more details: What are the Differences between Registration and Filing of Health Food?).

The main contents are as follows:

(1) Application scope

For domestic health food, the raw materials used in filing products should be included in the Health Food Raw Materials Directory. Products using raw materials not included in the Directory must apply for registration.

For imported health food, the first imported nutrition (including vitamins and minerals) supplement products should apply for filing, and other first imported health food except nutrition supplements should apply for registration.

(2) Test requirements

Except for the tests that must be carried out for both registration and filing (such as tests on functional components, hygiene, and stability for three batches of products), there are several additional tests required for registration, including toxicology tests, animal function tests, and (or) human food trials.

(3) Dossier requirements

In addition to the different requirements for test reports, the main difference between health food registration and filing dossiers is that registration product is required with a comprehensive research and development report while filing product is not.

(4) Application procedure

Health food registration procedure is more complex, including expert technical review, on-site inspection and re-testing (depending on the technical review results), and so on.

Compared with registration, the filing procedure is relatively simple. The relevant materials are reviewed by the provincial administration for market regulation (for domestic products) or the Center for Food Evaluation (for imported products), without requirements for expert technical review, on-site inspection, and re-testing.

(5) Estimated application time

Based on the differences between health food registration and filing in terms of test requirements, dossier requirements, and application procedure, the estimated time for registration is 2-3 years, which is longer than filing which will be in about 8-10 months.

Q: What are the qualification requirements for applicants of health food filing?

A: The filers of domestic health food should be the manufacturer; while filers of imported health food should be the corresponding overseas manufacturer or another enterprise*.

*The filer of imported health food is not limited to the manufacturer. The owner of the product and other non-manufacturing enterprises can also be the applicant. The product can be entrusted to other enterprises outside the country for production.

Q: What are the qualification requirements for applicants of health food registration?

A: Registers of domestic health food should be a juridical person or other enterprise registered in China; while registers of imported health food should be the corresponding overseas manufacturer or another enterprise.

*The registers of health food is not limited to the manufacturer, no matter domestic or imported. The owner of the product and other non-manufacturing enterprises can also be the applicant. The product can be entrusted to another enterprise for production.

Q: Are foreign test reports on animal tests and human food trials valid in China?

A: No. The animal function tests and human food trials must be conducted by China’s qualified inspection agencies.

Q: For health food sold on cross-border e-commerce platforms, how can overseas food manufacturers register with the General Administration of Customs, P.R. China (GACC)?

A: According to the Regulations of the People's Republic of China on the Registration and Administration of Overseas Manufacturers of Imported Food (GACC Decree No. 248), health food sold on cross-border e-commerce platforms is not required to conduct an overseas manufacturers registration.

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