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Health Food
From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on health food to help you gain a clearer understanding of the current requirements in China.
On February 8, 2024, in alignment with the Food Safety Law of the People’s Republic of China, the State Administration for Market Regulation (SAMR) issued the drafted Technical Requirements for Filing Products with Health Food Raw Material Ginseng radix ET rhizome, Panacis quinquefolii radix, and Ganoderma for public comments. Comments are welcomed before March 8, 2024.
As of December 31, 2023, the State Administration for Market Regulation (SAMR) issued a total of 1,456 health food (dietary supplement) registration approvals, 749 of which are for new health food products. CIRS Group has conducted a detailed summary and analyzed them from the following perspectives.
In order to help enterprises better understand the status of health food (dietary supplements) filing in China, CIRS Group has gathered statistics on health foods approved in 2023 and analyzed them from multiple perspectives.
With the release of the new regulations for health food registration, the State Administration for Market Regulation (SAMR) issued the Key Points for the Review of the Change of Registration Certificate for Health Foods with No Validity Period and No Technical Requirements in Production and Sale (Draft) on December 27, 2023, for public comments, to standardize the health food registration certificates with no validity period and technical requirements issued by the former Ministry of Health (MOH). The deadline for public comments is January 26, 2024.
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.