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Chinese New Regulation for Health Food Products

China is a huge market for the dietary supplement industry. Knowledge of China’s health food product regulation system would help more U.S. and international companies have great success in the Chinese market.

According to Business Wire Research and Market, the total sales of health food in China was estimated at nearly RMB140 billion (US$22.2 billion) in 2013. With the release of The Food Industry’s Second Five-Year Plan by the Chinese State of Council, the health food industry demonstrates a promising future. It is estimated that by 2019, the sales of health food in China will reach RMB300 billion (US$47.5 billion). The Chinese government released the “2015 China National Nutrition and Chronic Diseases Report" on June 30, 2015. According to the report, the obesity rate was 11.9 percent in 2012, representing an increase of 67.6 percent since 2002. The obesity rates for children ages six to 17 years doubled. Deficiency of nutrients such as calcium, iron, vitamin A and vitamin D still exist. The adult population with high blood pressure was 25.2 percent. The cancer ratio is 235 per 100,000 people, with lung cancer and breast cancer as the top cancers in men and women, respectively. There will be a huge demand for health food products in China market.

More Chinese consumers are looking for high-quality foreign health food products such as dietary supplements from the United States. A lot of Chinese companies are also starting to purchase or merge with foreign health food product companies, and enter the international market to bring high-quality products to China.

Chinese Health Food Product Registration and Regulation

For foreign health foods to get into China, the health food registration process is a slow process. It will take two to three years, and 60,000 to 100,000 RMB (US$9,500 to $15,800) to get one product registered under the blue hat registration system. There are a total of 15,000 health products approved by CFDA (China FDA) so far. In 2014, the number of total approved health products amounted to 1,350 products, with domestic products at 1,338 (99 percent), and imported products at 12 (less than 1 percent). Health nutritional products were 374 (28 percent), health functional products were 976 (72 percent). The number one health function product category was “increasing the immune system," and the second was “fatigue reduction and increased bone density."

The new Chinese Food Safety law was officially passed in April 2015, which included 13 items related to health food regulation. It went into effect on Oct. 1, 2015. According to the new Food Safety Law, a detailed management method draft for health food also released by CFDA, major changes include:

  • A new notification system for products that use dietary ingredients from the health food ingredients catalog (domestic products), and vitamins and minerals products (imported products); and
  • The Provincial CFDA will oversee the domestic health food product notification.

Importantly, imported health foods must be marketed in the producing country for at least one year before being registered or notified in China. All application materials must be in the Chinese language with materials in the original language attached as reference. All the materials must be translated into Chinese if originally in a foreign language. A Chinese notary needs to attest that the translation is consistent with the original.

Chinese Health Food Ingredient Catalog and Health Claim Catalog

CFDA also released the draft regulation for health food ingredients and health claim catalog. CFDA will build a database for the ingredients and claims that can be used for health food products, and will update the database. 

The new health function claim catalog refers to a list of permitted health function claims that can be used for health foods. All the claims are based on test methods and criteria that have been systematically evaluated and verified. Right now, 27 health claims are allowed for health functional products. The health function claim catalog provides the possibility of new health function claims as long as the claim can be evaluated and verified.

The health food ingredient catalog refers to a list of ingredients that have been approved for use in health food products. Each ingredient in the catalog includes the following information: ingredient name, ingredients formulation, usage amount, permitted health function claims, quality standard, active components, testing methods and related information, etc. The key purpose of the catalog is to determine whether a health food is subject to registration or notification. Only vitamins and minerals listed in the catalog can be freely used together to produce multi-vitamin/mineral health products. For other ingredients and combination in the catalog, the use of two or more ingredients in one health food product must provide sufficient scientific justification and the history use.  

China is a huge market for the dietary supplement industry. Knowledge of China’s health food product regulation system would help more U.S. and international companies have great success in the Chinese market.

The information is based on our best knowledge and is for reference only. It has no legal value. Davidia Healthtech LLC declines all responsibility or liability whatsoever for errors or deficiencies in this document. Authorities in various countries have the rights to determine products regulatory status. Law and the related guidance change constantly. We cannot guarantee regulations referred to in the document have stayed unchanged. The text should not be taken as an authoritative statement or interpretation of the law, as only the courts have this power. Every effort has been made to ensure that these guidance notes are as helpful as possible

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