How to Apply for New Function of Health Food (Dietary Supplement) in China? SAMR Issued the Detailed Rules (Draft)

On August 2, 2022, SAMR issued Detailed Rules for Technical Evaluation of New Functions of Health Foods (Trial) (Draft) for public comments. The deadline for comments is September 1, 2022.

The Detailed Rules (Draft) is the supporting document of Administrative Measures on Health Food Raw Material Directory and Function Directory, and the public can apply for new function of health food according to the requirements in this document. This means that in the future, health functions in China will no longer be limited to the currently proposed 24 health functions, other health functions such as health functions that have been approved in other countries, or the innovative developed health functions, etc., will have the chance to be included in the directory of health function as well.

Highlights of the Detailed Rules (Draft) are as follows:

1. The person who proposes the new function can be any unit or individual. If the proposer is an individual, the proposer should in association with the qualified as health food registration applicant, to propose the new function of health food.

2. The application for new function and the application for health food with new function should be carried out simultaneously.

3. The research sample of new function can be newly developed health food with new function, common food that have been marketed and found to have the new function, or approved health food registration/filing product, etc.

4. The evaluation method research and methodological validation of new function should be carried out in depth.

5. The proposer should prepare the application materials according to the attached table of the Detailed Rules (Draft) and relevant regulations of health food registration. After the application materials are approved by SAMR, the health food with new function can be marketed conditionally, and the post-market surveillance of this health food will be carried out for a period of 5 years. When the monitoring period expires, and the evaluation results of post-market surveillance are satisfied, the new function will be approved formally and be included in the health food function directory.

Reference

SAMR Notice