China regulates health foods as a category of special foods under the country’s food-safety framework. Unlike countries that use a single notification mechanism for food supplements, China operates a registration and filing system for health foods. This pathway depends on the ingredients, type of product, and whether it is imported or domestically produced.
The State Administration for Market Regulation (SAMR) is responsible for the central health-food registration framework. Products that qualify for filing are handled through the applicable filing system, while products requiring registration undergo a formal registration review. There’s another notable layer for overseas manufacturers exporting to China.
This guide breaks it all down, detailing health food regulations, registration, labeling, and import compliance requirements in the country.
Regulatory Authority for Health Foods in China
The State Administration for Market Regulation (SAMR) is the most important regulatory body for health food registration and filing in China. The registration process is an administrative-licensing procedure handled by the SAMR Food Evaluation Center. It manages official application requirements, documents, processing stages and certificate information.
For imported filing, it is product licensing plus a separate regulatory mechanism. GACC handles imported products and the registration of overseas food production enterprises.
Under the current Decree No. 280, which has been in effect since June 1, 2026, overseas enterprises exporting food to China must obtain GACC registration, subject to the applicable risk-based registration framework.
What Are Health Foods Under Chinese Regulations?
Health supplements are regulated as health foods in China. These products that claim health benefits should also have proper scientific backing and should not lead to acute, subacute, or chronic harm to the human body.
The regulatory system is based in part on catalogues of permitted raw materials and permitted health functions. For example, SAMR, together with the National Health Commission and National Administration of Traditional Chinese Medicine issued the 2023 edition of the Health Food Raw Materials Catalogue for Nutrient Supplements and the corresponding catalogue of permitted health functions.
The raw-material framework covers matters such as raw material name, daily use quantity, suitable/unsuitable population, applicable function, and technical requirements.
The actual formulation and the intended regulatory function should be the basis for a product’s assessment. It shouldn’t be simply marketed as a supplement in another country.
Health Food Registration vs. Filing in China
China’s Measures for the Administration of Health Food Registration and Filing define registration as a formal review of a health food’s safety, health function, and quality controllability. On the contrary, filing is a process under which the required materials are submitted for record and public inspection.
| Requirement of Health Food Registration | Need for Health Food Filing |
The current rules provide for registration of:
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Health Foods Registration Process in China
Health foods are required to go through the Health Food Filing and/or Health Food Registration process in order to be sold in the Chinese market. Here is the step-by-step approval process.
Step 1: Check if the Product Needs Filing or Registration
Products with health function claims or products not included in the directories approved by the Chinese government require Health Food Registration. Imported vitamin and mineral foods that meet the Chinese-approved ingredient directories may be considered for Health Food Filing.
Companies can assess product formulation, raw materials, nutritional/functional ingredients, intended health function, whether the product is imported or is a first import, and if the applicable ingredients appear in the current catalogue to decide the regulatory route.China does not allow a company to choose the simpler route merely because the product is already authorised in another country.
Step 2: Verify the Permitted Health Function
China uses catalogue-based management for health-function claims. For non-nutrient-supplement health foods, SAMR published the 2023 Health Function Catalogue. It covers 24 permitted health functions, together with corresponding technical guidance and evaluation methods.
The catalogue-based system means companies cannot create a new health-function claim simply by providing their own scientific justification. The applicable product function must correspond to the regulatory framework and supporting technical requirements. For nutrient-supplement products, SAMR separately published the 2023 catalogue of permitted functions for nutrient supplements.
Step 3: Determine the Applicant Structure
An imported health food that needs registration will identify the overseas manufacturer as the registration applicant of the marketed product. Their permanent representative office in China or a Chinese agency appointed by them will look after the registration process. Overseas manufacturer would be the filing party for imported filing.
Step 4: Prepare a Registration or Filing Dossier
The official SAMR registration service provides a detailed list of application materials. The registration application includes the following, among other requirements:
- Health food registration application form
- Legal-responsibility undertaking
- Applicant’s registration/qualification documents
- Product R&D report
- Product formulation
- Manufacturing-process documentation
- Safety and health-function evaluation material
- Packaging-material information
- Product label and instruction samples
- Product-name search documentation
- Three samples in the smallest sales package
- Other materials relevant to registration review
Imported products will require supporting documents from the country of origin as well.
Filing has a different documentary structure. Under the Health Food Registration and Filing Measures, filing requires the prescribed filing form and legal-responsibility undertaking, applicant qualification documents, product technical requirements, a full inspection report from a legally qualified testing institution and other materials demonstrating product safety and health function. For imported health food filing, additional documents from the first-import provisions must also be submitted.
Step 5: Submit the Application to SAMR
The official SAMR government-service platform identifies health-food registration as an administrative licensing service, received by the SAMR Food Evaluation Center. For registration, the formal administrative stages include application acceptance, review and approval.
For qualifying filing products, the regulatory framework provides that where the filing materials meet the requirements, the filing is completed and a filing number is issued. If the materials are incomplete, the filing applicant is notified of the required corrections.
Step 6: Complete Regulatory Review
SAMR will conduct an application review and may seek additional information as part of the review. It can involve checking the scientific evidence, product testing, stability testing, quality control assessment, manufacturing process assessment, on-site verification, and confirmatory testing.
In the case of an on-site inspection, the inspection body is given 30 working days to complete it under the registration rules. Confirmatory testing is generally subject to a 60-working-day period. Time for overseas on-site inspections and confirmatory testing is decided according to the actual circumstances of the overseas manufacturer.
Step 7: Obtain Approval
After approval, SAMR will issue a Health Food Registration Certificate or Health Food Filing Certificate. It’ll have information regarding the product name, registrant, registration number, health function, functional/marker components and contents, product specifications, shelf life, suitable/unsuitable population, and precautions.
Documents Required for Imported Health Food Registration in China
For a first-imported health food requiring registration, additional materials include the following:
- Evidence that the applicant is the overseas manufacturer legally marketing the product
- Evidence showing that the product has been marketed in the country/region of production for at least one year, or a safety report covering the product’s overseas sales and human consumption
- Relevant food technical regulations or standards from the country/region of production or an international organisation
- Samples of the packaging, label and instructions used in the country/region of production.
The underlying registration requirements also call for scientific and technical documentation supporting the product’s safety, health function and quality controllability.
Product-Quality Documentation
For registration, the technical requirements can address product name, formula, production process, sensory requirements, identification, physicochemical indicators, and microbiological indicators, functional or marker components and test methods, net-content/weight-variation requirements, and raw-material quality requirements.
The official registration guidance also requires stability studies appropriate to the sample’s characteristics, with the findings used to support storage conditions, packaging and shelf life. So stability, testing and technical quality information are genuinely relevant to the registration dossier. They should not, however, be presented as if the exact same dossier applies to every filing product.
Health Food Registration Timelines in China
There are several timelines that should not be confused.
| Formal SAMR Registration Service |
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| Addition Registration Review Activities |
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| Filing |
Where the filing materials satisfy the requirements, the filing rules provide for on-the-spot filing and issuance of a filing number.
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Health Food Registration Costs in China
The cost of registration depends on the approval pathway and product requirements. There is generally an increase in registration costs due to additional testing and technical review requirements.
Key cost drivers include:
- Product testing
- Stability studies
- Toxicology studies (if required)
- Dossier preparation and translation
- Chinese agent fees
- Additional information requests during the review process
Products eligible for registration generally incur higher costs than products eligible for filing. GACC registrations have no government registration charge.
Compliance Checklist for Health Foods in China
Prior to registering, companies are advised to ensure that:
- The product is in line with Chinese health food regulations.
- The raw materials have been checked against the applicable catalogue.
- Registration vs filing has been determined.
- Ingredients & formulations meet China’s requirements for Health Food ingredients.
- The claimed health benefits are allowed.
- Prepared product technical requirements are available.
- Required safety, health function, and quality evidence is available.
- Manufacturing is documented.
- Product testing can be carried out.
- Labels and packaging meet China’s labelling regulations.
- A Chinese agent or representative is hired for imported products.
- GACC requirements for overseas production enterprise
- All necessary documents are ready for submission.
Labelling Requirements for Health Foods in China
If they are to be marketed, Health Foods need to meet China’s labelling requirements. Labels are required to be in Chinese and match the approved registration or filing information.
- Product name
- Raw Materials
- Excipients
- Functional or marker components and their quantities
- Health function
- Consumption amount and method
- Product specifications
- Storage conditions
- Shelf life
- Health food identification/ registration/filing info
- Required statement: “This product is not a substitute for medicine.”
China’s rules also prohibit health-food labels and instructions from presenting the product as having disease-prevention or treatment functions. Product names themselves are regulated. The rules prohibit names containing false, exaggerated or absolute wording and prohibit wording that expressly or implicitly suggests disease prevention or treatment.
Health Claims and Advertising Regulations for Health Foods in China
China only allows approved Health Food claims and does not allow disease-related claims. Advertising content must be in accordance with the approved registration or filing information.
- Only approved health claims are permitted.
- No disease prevention or treatment claims are allowed
- Approved claim wording must be used
- “This product is not a substitute for medicine” is mandatory
Manufacturing & Quality Requirements for Health Foods in China
The registration framework emphasises quality controllability. The technical requirements for a registered product can include the formulation, production process, sensory criteria, analytical methods, physicochemical and microbiological indicators, functional/marker components and raw-material quality requirements.
The registration guidance also requires appropriate stability studies and use of the results to determine storage conditions, packaging and shelf life. This means that companies should maintain the following:
- Manufacturing controls
- Raw-material controls
- Analytical methods
- Quality specifications
- Stability programmes
- Batch records
- Traceability records
- Packaging controls
GACC Registration for Overseas Manufacturers
China Customs separately regulates overseas food-production enterprises exporting food to China. The current GACC service provides two registration routes:
- Recommendation by the competent authority in the country/region of the manufacturer
- Enterprise application, either directly or through an agent.
GACC may carry out assessment through document review, video inspection, on-site inspection, or a combination of these approaches. The overseas enterprise must be legally established and under the effective supervision of the competent authority in its country/region. They must maintain an effective food-safety and hygiene management/protection system, legally produce and export food, and comply with relevant inspection and quarantine requirements.
GACC Registration Documents
The current GACC service identifies documents/information, including:
- Competent-authority recommendation letter, where the recommendation route applies
- Competent-authority inspection report or applicable registration-condition checklist, where required
- Overseas food-production enterprise registration information
- Enterprise identity documentation
- Compliance undertaking
- Food safety, hygiene and protection system information, production type and capacity where regulatory review requires it.
The official GACC service currently states that there is no registration fee.
Importing Health Foods Into China
An imported health food therefore needs to be assessed at both product and establishment level.
Product Side
Determine whether the product requires SAMR registration or filing.
Overseas Manufacturer Side
Confirm whether the overseas production enterprise requires GACC registration and which registration route applies.
Shipment/Import Side
The importer should ensure the imported product and its regulatory documents correspond to the registered/filed product and applicable Chinese import requirements.
Conclusion
Imported health foods must obtain either a Health Food Registration Certificate or a Health Food Filing Certificate before they can be marketed in China. Determining whether a product qualifies for Filing or requires Registration is the first step in developing an effective China market entry strategy.
Partnering with an expert can help you go through the China regulatory process smoothly. With Artixio, product registration in China becomes simpler as our team ensures end-to-end compliance. To know more, get in touch with us at info@artixio.com.
FAQs
What is the difference between Health Food Registration and Filing in China?
Health Food Filing is generally available for eligible vitamin and mineral foods, while products with functional health claims or non-directory ingredients typically require full Health Food Registration.
Can foreign companies apply for Health Food Registration in China?
Yes. Foreign manufacturers can apply, but they must appoint a Chinese agent to manage the registration or filing process.
How long is a Chinese health-food registration certificate valid?
A health-food registration certificate is valid for five years.
