China Health Food Regulation

1. Competent authority

Competent authority	Responsibility
State Administration for Market Regulation (SAMR)	Market supervision Administration on special food, including infant formula registration
National Health Commission (NHC)	National standard drafting New food ingredient registration
General Administration of Customs of China (GACC)	Customs inspection, quarantine, and declaration Overseas food manufacturers registration

2. Market access approval

2.1 Import permit at state level

Only health food products that meet corresponding national standards and have obtained the health food certificate (the "blue hat") are allowed to be exported to China.

2.2 Overseas manufacturer registration

According to the Administrative Provisions on Registration of Overseas Manufacturers of Imported Foods, overseas manufacturer registration is mandatory for all imported food products. The registration of health food manufacturers should be recommended by competent authorities in exporting countries.

Recommended resources:

2.3 Inspection and quarantine

Imported health food products are subject to imported food sanitation inspection. Inspection items include Chinese label, foreign matter, the existence of prohibited food additives and other items related to sanitation.

2.4 Exporter and importer filing

Regardless of food categories, overseas exporters or agents as well as importers in China shall log into this system and get themselves filed with GACC.

To have a better understanding of China's food import procedure and supervision mechanism, please check ChemLinked online course: Regulatory Compliance and Import Procedure of Prepackaged Food in China.

2.5 Product registration

Imported health food products shall obtain the health food certificate (the "blue hat") by product registration or filing with SAMR.

Health food that has specific health functions, such as immunity enhancement and memory improvement, is required to be registered with SAMR when first imported to China. Besides, health food that contains raw materials beyond the scope of permitted raw material catalogue for health food is also required to be registered.

Health food that supplements vitamins or minerals, such as vitamin C and calcium, is required to be filed with SAMR when first imported to China. Besides, health food that contains raw materials from the permitted raw material catalogue for health food is also required to be filed.

2.5.1 Checklist of dossier

For the application of health food registration and filing, the corresponding required dossiers should be submitted.

Health Food Registration	Health Food Filing
1. Health Food Registration Application Form, along with a Legal Responsibility Commitment Letter from the applicant ensuring the authenticity of submitted materials	1. Health Food Filing Application Form, along with a Legal Responsibility Commitment Letter from the filer ensuring the authenticity of submitted materials.
2. Copy of the registration applicant's business license or entity registration documents	2. Copy of the filing applicant's business license or entity registration documents.
3. Product R&D report	3. Product technical requirements documentation
4. Formula materials	4. Formula materials
5. Production process materials	5. Production process materials
6. Safety and functional evaluation materials	6. Safety and functional evaluation materials
7. Types, names, and standards of direct-contact packaging materials	7. Types, names, and standards of direct-contact packaging materials
8. Draft product labels and instructions	8. Draft product labels and instructions
9. Documentation confirming that the product's generic name does not duplicate registered drug names or approved health food names	9. Documentation confirming that the product's generic name does not duplicate registered drug names or approved health food names
10. Three samples of the smallest sales packaging	10. Full-item inspection report compliant with product technical requirements, issued by a qualified testing institution
11. Other materials related to registration review	11. Other materials demonstrating product safety and functionality
12. Qualification certificates for overseas manufacturers, issued by the competent authorities or legal institutions in the country/region of production
13. Proof of market availability for ≥1 year in the country/region of production, issued by competent authorities or legal institutions
14. Technical regulations/standards from the country/region of production, self-inspection reports on quality management systems, and GMP certification
15. Samples of packaging, labels, and instructions used in the country/region of production
16. Registration Certificate for Permanent Chinese Representative Agency of Foreign Companies and its copies (for overseas manufactures which are represented by permanent representative office in China for registration)
17. Power of Attorney after notarization and the copies of business license of the entrusted agency (for foreign manufacturers which are represented by domestic agencies in China for registration)

Notes: Items in red only applies to imported products. In addition, for these documents issued by a contracting party to the Convention of 5 October 1961 Abolishing the Requirement of Legalization for Foreign Public Documents, consular authentication from the country and the Chinese embassy or consulate in the local area is no longer necessary, only an Apostille of that country is required.

Recommended resources:

Webinar: Things to Know Before Exporting Health Supplements & Vitamins to China
Webinar: The Latest Regulatory Updates on and Trends of China's Health Food
Online course: Food Digital Week Session 2: Health Food

3. Product compliance

3.1 Product requirements

GB 16740-2014 Health Food specifies the definition and technical requirements (ingredients, sensory requirements, physicochemical indicators, microorganism level, etc.) of health food.

Health food product

Product requirements

Health Food Subject to Registration

Product function: 24 health functions stated in Health Function Catalogue Allowed for Health Food Claims Non-Nutrient Supplement (2023).
Dosage forms: 18 forms include tablet, powder, granula, tea, hard capsule, soft capsule, oral liquid, pill, paste, beverage, alcohol, biscuit, candy, pastry, liquid dairy, raw material extract, nutrient complex, and others.
Food raw materials:
Permitted:

(1) Ordinary food ingredients

(2) Catalogue of Substances Traditionally Considered as Both Food and Chinese Medicine

(3) China Approved New Food Raw Materials

(4) Substances Permitted to Be Used in Health Food

(5) Health Food Raw Materials Directory - Nutrient Supplement (2023)

(6) Bacterial Cultures Permitted in Foods

(7) Fungi and Probiotics Permitted in Health Food in China

Prohibited:

(1) Substances Prohibited from Being Used in Health Food

(2) Substances that May Be Added into Health Food Illegally

Food auxiliary materials: all approved food additives and nutritional fortification substances can be used. Check China Food Additives Database for more details.

Health Food Subject to Filing

Product function: supplement vitamins or minerals, check Health Function Catalogue Allowed for Health Food Claims - Nutrient Supplements (2023) for more details.
Dosage forms: 7 forms specified in Dosage Forms and Technical Requirements for Health Food Filing (2021 Edition)
Food raw materials: permitted:

(1) Health Food Raw Materials Directory - Nutrient Supplement (2023)

(2)* Coenzyme Q10, Melatonin, Fish oil, Reishi shell-broken spore powder, Spirulina, Soybean protein isolate, Whey protein, Ginseng, American Ginseng, and Lingzhi (Ganoderma)

*Note: Only Chinese domestic health food using these new food raw materials subject to filing. Imported health food using these new food raw materials needs to be registered before import.

Food auxiliary materials: List of Auxiliary Materials for Health Food Filing and Terms of Use (2021)

3.2 Label

With reference to Regulations of the People's Republic of China on the Registration and Administration of Overseas Manufacturers of Imported Food, the registration number of registered overseas health food manufacturers should be marked on both internal and external package of imported health food products.

According to the Administrative Measures on Safety of Import and Export Food, the Chinese labels of imported health food must be printed on instead of affixed to the smallest sales package before import.

The labeling of health food shall follow the requirements specified in GB 7718-2011 General Standard for the Labeling of Prepackaged Foods and Administrative Measures for Registration and Filing of Health Foods.

The label and instructions shall not involve any information implying the prevention or treatment of diseases. The content of the label and instruction shall be true and identical to the registered or filed information; clearly indicate the suitable and unsuitable groups, functional ingredients or significant ingredients, and their content; and declare "the product is not a substitute of medicine". Product functions and ingredients shall be consistent with what indicated in the label and instructions.

3.3 China Health Food Registration and Filling Services

We have been equipped with a professional technician team to provide a one-stop registration service with expertise and efficiency. Our services include:

Feasibility assessment (formula check, data gap analysis, test analysis, budget evaluation, etc.)
Health food registration (product research, dossier preparation & submission, test monitoring, communication with SAMR )
Health food filing (product research, dossier preparation & submission, test monitoring, communication with SAMR )

Please feel free to contact us via food@chemlinked.com if you need any help.

Tags: Chinese Mainland Health Supplement Registration Importation