Food Compliance
Intelligence & Solutions
China Health Food Regulation
May 26, 2022
Jerry Wang
Pedia Details Our Service Read More
CONTENTS

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. 

Recommended resources:

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

       (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 (1st Batch)

       (6) Bacterial Cultures Permitted in Foods

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

    Prohibited: (1) Materials Not Allowed to be Used as Ordinary Food Raw Materials in China

       (2) Substances Prohibited from Being Used in Health Food

       (3) 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

       (1) Health Food Raw Materials Directory - Nutrient Supplement (2020)

       (2) Coenzyme Q10, Melatonin, Fish oil, Reishi shell-broken spore powder, and Spirulina. 

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

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 GB 28050-2011 General Rules for Nutrition Labeling of Prepackaged 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. 

ChemLinked has helped hundreds of global food enterprises in terms of market access. Please feel free to contact us if you need assistance on health food registration/filing, or any consultation service.