On 20 August 2019, State Administration for Market Regulation (SAMR) released the Administrative Measures on Health Food Raw Material Directory and Function Directory, which will come into force on 1 October 2019. According to this regulation, ANY UNIT OR INDIVIDUAL could apply for new health function or apply to list some food ingredients into the filing scope in China.
This is a completely new regulation in China, which shows the Chinese government's more opening attitude towards health food management. In the future, the health functions in China will not be limited to the current 27 functions, and a channel for applying new functions will be established. The same is true for the new raw materials for filing.
Furthermore, this regulation has no effect on the current health food registration or filing application.
1. Highlights of the criteria for being accepted by health raw material / function directory
Highlights of criteria
Raw materials can be included into health food filing scope
new health functions can be included into Health Function Directory
2. The application procedures
3. Required dossiers
3.1 Application of adding new raw materials to health food filing scope
- Name of the ingredient;
- Scope of daily intake and the corresponding health function;
- Technological process, quality standard, range of the functional/characteristic components and the detection methods, suitable/unsuitable crowds, precautions, etc.;
- Reports of adverse reactions after human consumption;
- Other related materials.
3.2 Application of new health function
- Name of the health function, as well as mechanism and naming basis;
- R&D report of the health function;
- Evaluation methods of the health function, and corresponding function test reports;
- The function-related materials at domestic and foreign;
- Scientific literatures and other related materials.
When applying for the adjustment of current Health Food Function Directory, provide the reasons, basis and relevant materials for the adjustment.
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