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.
CIRS has summarized the key points of the Detailed Rules as follows:
(1) The applicant can be any organization or individual. Based on relevant research, any organization or individual can independently or jointly submit new function applications to the Center for Food Evaluation of the State Administration for Market Regulation, hereinafter referred to as CFE.
(2) To include a new function in the Directory of Health Functions Available to Be Claimed for Health Food, research and technical evaluation of the health food with new functions should be conducted, followed by a post-market assessment.
(3) Regarding the new function research:
- The new functions for health food should be clear and can be categorized into three types, namely supplementing dietary nutrients, maintaining or improving body health, and reducing risk factors for diseases;
- The research samples for new functions should either be newly developed health food with the corresponding new function or approved health food that has been identified as possessing the new function through research; and
- The research should include thorough evaluation methods and methodological validation of the new function. Prior to proposing a new function, a validation assessment should be conducted by at least one accredited food inspection agency or clinical trial organization as required.
(4) Regarding the application dossier:
- When applying for new functions, the applicant shall provide technical evaluation materials according to the Attachment of the Detailed Rules;
- When applying for the registration of health products with new functions, the materials shall be prepared according to the relevant regulations of health food registration, and the applicant shall meet the qualification requirements.
(5) CFE reviews the dossiers for the proposed new function and registration application dossiers for corresponding health food with the new function. For new function proposals with a technical evaluation conclusion suggesting inclusion in the Directory of Health Food Functions, CFE will subsequently submit the conclusion to SAMR. As a result, those meeting the requirements will be included in the Directory.
(6) For newly approved health food with new functions, the applicant is required to conduct post-market evaluations as follows:
- Develop a post-market evaluation scheme and prepare annual self-inspection reports; and
- In addition to fulfiling the dossier requirements for registration renewal, validation assessment should be conducted by at least two qualified food inspection agencies or clinical trial organizations as required no later than six months before the expiration of the registration certificate.
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