With the release of the Directory of Health Functions Available to Be Claimed for Health Food - Non-nutrition Supplements (2023 Version) (hereinafter referred to as the 2023 Directory) and the supporting documents by the State Administration for Market Regulation (SAMR) on August 31, 2023, the long-awaited change of health food registration certificate policy is finally in place after nearly 20 years. Among the various aspects, the one that attracts the most attention from businesses is the change of certificates for products without validity period and technical requirements.

From our years of regulatory compliance experience, we've translated a selection of some frequently asked questions on health food to help you better understand the current requirements in China.

In China health food is usually defined as food product that have specific health function or supply vitamins and (or) minerals. With the goal of regulating body's function, health food is suitable for specific groups of people. However, it is not used for the purpose of curing disease and causes no acute, sub-acute or chronic health effect to human body. The Definitions/Names of these Food Products in Different Countries are Different: China: Health Food EU: Food Supplement

On August 28, 2023, the State Administration for Market Regulation (SAMR) issued the Detailed Rules for Technical Evaluation of New Functions and Products of Health Food (Trial) (hereinafter referred to as the Detailed Rules), which takes effect on the day of publication. The Detailed Rules serve as the supplementary document of the Administrative Measures on Health Food Raw Materials Directory and Function Directory, providing more comprehensive requirements for the application of health food new functions and products. Enterprises can now refer to the Detailed Rules for a clear understanding of the application processes, dossier, and testing requirements. This marks a significant shift where health functions will no longer be confined to the current 24 functions outlined in the Directory of Health Functions Available to Be Claimed for Health Food – Non-nutrition Supplements (2023 Version), and a broader range of new health functions are expected to be included in the Directory of Health Food Functions.

The Technical Specifications for Testing and Evaluation of Health Food (2003 Version) was abolished in July 2018. After five years, on August 31, 2023, China’s State Administration for Market Regulation (SAMR) finally released the Directory of Health Functions Available to be Claimed by Health Food – Non-nutrition Supplements (2023 Version) and the supporting documents, including the long-awaited health food function evaluation methods.

From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on health food and common food to help you better understand the current requirements in China.

China offers a wide range of food categories in addition to complex food regulations and standards. It is crucial to precisely determine whether the raw materials and additives used in a food product comply with Chinese regulatory standards before it is imported or launched on the market. How do you verify the compliance of food raw materials? What is the scope of use and amount of food additives permitted? Typically, these types of queries call for food enterprises to carry out multiple inquiries and research.

According to the information released by the Center for Food Evaluation, State Administration for Market Regulation and the Special Food Information Query Platform, in the first half of 2023, State Administration for Market Regulation issued a total of 670 health food (dietary supplement) registration approvals, 358 of which are new health food products.

On June 14, 2023, the State Administration for Market Regulation released four official documents, including Health Food Raw Materials Directory of Nutrient Supplement (2023 Edition), Health Function Directory of Allowing Nutrition Supplement Claims (2023 Edition), Health Food Raw Materials Directory - Soybean Isolated Protein, and Health Food Raw Materials Directory - Whey Protein. On July 5, 2023, the supporting technical specifications and interpretation documents (draft for soliciting opinions) of the above-mentioned documents were released for public opinion. Comments are welcomed before August 4, 2023.

On July 18, 2023, we hosted a free webinar in Chinese and Japanese on health food registration and filing in China as well as an analysis of the difficulties. A lot of questions were raised during the webinar. CIRS Group has collected questions on health food and made a Q&A summary as follows: