A Guide to Exporting Health Foods and Supplements to China

Prior to exporting health food products to China, overseas manufacturers need to get pre-market approval of their products from CFDA. Under the current regulatory framework, a dual health food administrative system with separate requirements for health food registration and health food filing has been implemented in China.

1. Determine the category of your health food products

In China, health food can be divided into two categories, i.e. food with specific health functions and nutrient supplements.

Food with specific health functions is defined as: Food which shares common properties with general food and can regulate normal human physiological functions. It refers to food which is suitable for consumption by specific groups of people and has the effect of regulating human body functions, but is not used for the purpose of treating diseases.

Nutrient supplements: These products, with vitamins and minerals as major ingredients, are used for the purpose of supplementing nutrients. There are single-ingredient and multi-ingredient nutrient supplements with a clearly defined standard of permitted nutrients and additives.

2. Determine whether the registration system or filing system applies to your product

Registration system applies to:

Health foods using new raw materials
Health foods imported for the first time (excluding nutrient supplements)

Filing system applies to:

Health foods using raw materials within the approved health food raw material catalogue
Nutrient supplements (vitamin and minerals) (its nutrient substances should be included in the approved health food raw material catalogue)

If registration system is applicable to your product, please follow the steps as below:

Check whether ingredients fall within regulated scope of health food standards or are banned

There will be an approved health food raw material directory released by CFDA in accordance with “Administrative Measures on Health Food Raw Material Directory and Health Function Directory”.

Before the raw material directory is formally released, health food raw materials should be used within the scopes of:

Conventional food (including China food composition list, the food composition for conventional use or has the traditional application history)
Raw materials permitted in MOH No. 51 Document (including the list of substances Used as Both Food and Chinese Medicine, the list of substances that can be used in health food, and the list of substances prohibited to be used in health food)
Approved new food raw materials
Food additives listed in GB 2760 and GB14880, as well as new varieties of food additives listed in NHFPC Announcement
Fungi and probiotics that can be used in health food

Check whether the function claims are permitted

There will be an approved health food function directory released by CFDA in accordance with “Administrative Measures on Health Food Raw Material Directory and Health Function Directory”.

Before the function directory is formally released, the functional claims should be selected from the list below.

1. Enhancing immune function	2. Aiding blood lipids reduction	3. Aiding blood sugar reduction	4. Increasing antioxidants
5. Improving memory	6. Relieving body fatigue	7. Relieving eye fatigue	8. Facilitating lead excretion
9. Clearing throat	10. Aiding blood pressure reduction	11. Improving sleep	12. Increasing milk secretion and anti-mutation
13. Improving endurance during anoxia	14. Aiding protection against irradiation	15. Aiding weight loss	16. Improving growth and development
17. Increasing bone density	18. Improving nutritional anemia	19. Aiding protection against chemical liver injury	20. Removing acne
21. Removing chloasma	22. Improving skin moisture	23. Improving skin oil content	24. Regulating enteric bacteria flora
25. Facilitating digestion	26. Improving constipation	27. Aiding protection against gastric mucosa

Find a testing agency for health food registration

Prior to the application to CFDA for health food registration, it is required to carry out efficacy tests for health food in accredited labs. There have been 58 accredited labs for health food testing. Please see the below list of “CFDA-approved Labs for Registration of Health Foods” for your reference:

CFDA-approved Labs for Registration of Health Foods

Prepare the pre-market application dossier

Dossiers required for health food registration:

Contents	Remarks
Application form	Application form of health food registration, and legal liability commitment to the authenticity of the application materials made by the applicant
Qualification certification of the applicant	The copy of registration certification for the applicant
Product R & D materials	The R & D personnel, R & D date, R & D process, verification data above pilot production scale, materials out of the catalogue and product safety, health functions, demonstration report and relevant scientific evidence for quality controllability, and product technical requirements comprehensively confirmed according to the R & D result
Product formula materials	Name and dosage of raw materials and additive materials, production process, quality standard, basis of use for raw materials provided when necessary, instruction on the part used, inspection qualification certificate, variety authentication report
Product technology materials	Production process diagram and description, and key process control points and relevant instructions
Product safety and health function evaluation materials	Raw materials out of the catalogue and product safety, function test report, human consumption evaluation materials, effective ingredients or iconic composition test report, hygiene test report, stability test report, stain identification report, bacteria virulence test report, as well as the test report of stimulants and illicit drugs;
Packaging materials	Types, name, and relevant standards of packaging materials in direct contact with persons
Product labels and users’ directions	-
Three minimum sales package samples	-
For the registration of first-time imported health foods, the following supplementary materials should be submitted as well:
1) Qualification certification of the applicant issued by the competent authority of the producing country (district) or legal service agency proving the applicant is the overseas listed health food manufacturer;
2) The documents granted by the competent authority of the producing country (district) or legal service agency, proving the products have been sold for more than one year, or the safety report on product overseas sale and human consumption status;
3) Technical regulation or standard related to health food of the producing country (district) or international organizations;
4) The samples of package, label and users’ directions of the products used in producing country (district)

If the filing system is applicable to your product, please follow the steps as below:

Check whether ingredients are permissible or banned

At current stage, the first batch of approved health food raw materials have been released for public consultation, which mainly include the approved raw materials for nutrient supplements (see CL news report on Feb. 19, 2016). It can be taken as a reference for checking if the functional ingredients are approved to be used in nutrient supplements.

Check whether the function claims are permitted

Nutrient supplements can only carry claims purporting to supplement normal vitamins and/or minerals intake.

Prepare the pre-market application dossier

Dossiers required for health food filing:

Contents	Remarks
Application form	Application form of health food filing, and legal liability commitment to the authenticity of the application materials made by the applicant;
Qualification certification of the applicant	The copy of registration certification for the applicant
Product formula materials	Name and dosage of raw materials and additive materials, production process, quality standard, basis of use for raw materials provided when necessary, instruction on the part used, inspection qualification certificate, variety authentication report
Product technology materials	Production process diagram and description, and key process control points and relevant instructions
Product safety and health function evaluation materials	Raw materials out of the catalogue and product safety, function test report, human consumption evaluation materials, effective ingredients or iconic composition test report, hygiene test report, stability test report, stain identification report, bacteria virulence test report, as well as the test report of stimulants and illicit drugs;
Packaging materials	Types, name, and relevant standards of packaging materials in direct contact with persons
Product labels and users’ directions	Product labels and users’ directions, the retrieval materials to verify the generic name of health foods to be registered is not repeated with the names of registered drugs;
Testing report	Full item testing report proving the compliance to product technical requirements issued by the testing agencies with legal qualification;
For the registration of first-time imported health foods, the following supplementary materials should be submitted as well:
1) Qualification certification of the applicant issued by the competent authority of the producing country (district) or legal service agency proving the applicant is the overseas listed health food manufacturer;
2) The documents granted by the competent authority of the producing country (district) or legal service agency, proving the products have been sold for more than one year, or the safety report on product overseas sale and human consumption status;
3) Technical regulation or standard related to health food of the producing country (district) or international organizations;
4) The samples of package, label and users’ directions of the products used in producing country (district)

Label your product according to China’s regulation

For health food registration or filing, the product label and users’ directions should include product name, raw materials, additive materials, efficacy components or iconic components and their content, suitable group of people, unsuitable group of people, consumption volume and method, specifications, storage method, shelf life, matters for attention, as well as the formulation evidences and instructions.

No disease prevention or cure function should be mentioned in the label or users’ directions with the statement of “this product should not be a substitute of drugs”.

Importer and exporter filing

Importer and overseas exporters shall apply for filing to local inspection and quarantine institute, and login the imported food importer & exporter filing management system (http://ire.eciq.cn) to fill in and submit the filing application table and obtain relevant filing number.

CIQ inspection and quarantine

- Customs inspection: the importer or agent shall apply for customs inspection to local inspection and quarantine institution at the entry of health foods. The dossiers including contract, invoice, packing list, bill of lading, label template and its translated version shall be provided during the customs inspection. The importer or agent shall declare the information of product name, brand, country (district) of origin, specifications, quantity/weight, gross value, production date (batch number) as well as other information required by AQSIQ during the customs inspection.

- CIQ field inspection: check the consistency of goods and certificates, label check, and organoleptic inspection

- CIQ sampling inspection: “imported goods inspection and quarantine certificate” will be issued by inspection and quarantine institute if the inspection and quarantine is qualified.