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As per the notification released on August 2, 2022, the State Administration for Market Regulation (SAMR) unveiled the draft version of Detailed Rules on Implementation for Technical Evaluation of New Functions of Health Food (Trial) and announced to solicit public comments. Any feedback can be sent to [email protected] before September 1, 2022.
Major contents revealed by the draft
1. General principle
Any individual or unit (hereinafter referred to as the proposer) can individually or jointly put forward suggestions on new functions of health food to the food evaluation institution of SAMR (hereinafter referred to as the evaluation institution).
If the proposer is an individual, it shall jointly propose with legal persons or other organizations registered in China that meet the qualifications of health food registration applicants, or overseas manufacturers of health food with new functions that has already been put on the market.
2. Verification evaluation
The proposed new functions shall belong into one of three categories: supplementing dietary nutrients, maintaining or improving body health, and reducing disease risk factors.
The evaluation methods and criteria for new functions shall be verified and evaluated by at least one legally-qualified food inspection institution before proposing new functions. During the post-marketing monitoring period, health food with new functions shall pass the verification and evaluation by at least two legally-qualified food inspection institutions.
3. Evaluation procedures
The proposer needs to submit complete and clear documents to the evaluation institution. If the documents are accepted, the evaluation institution will conduct a technical evaluation timely, including an on-site inspection. Based on the evaluation results, the evaluation institution will give the conclusions as "The proposal basically meets the conditions for being included in the health function catalogue. It is necessary to carry out post-marketing monitoring and evaluation of the health food with new function" or "The proposal doesn't meet the conditions for being included in the health function catalogue". For the proposal granted with the former conclusion, the evaluation institution shall submit the proposal and related evaluation materials to SAMR. After approval from SAMR, health food with the proposed new function can be put on the market conditionally. The post-marketing monitoring and evaluation for health food with new function can be carried out for 5 years.
4. Evaluation checklist
The following points should be the emphasis of the technical evaluation for new functions:
Name, explanation, mechanism and basis of new function of the health food;
Research report about the new function;
Evaluation methods and criteria for new functions with corresponding verification and evaluation materials;
Domestic and foreign research and application status of the same or similar functions;
Relevant scientific literature and other materials.
Conditions for obtaining the conclusion "The proposal basically meets the conditions for being included in the health function catalogue. It is necessary to carry out post-marketing monitoring and evaluation of the health food with new function":
Complete application materials;
No social ethical concern caused;
Scientific, rational and intelligible name and explanation of the proposed new function;
The purpose of the new function does not involve the prevention, treatment and diagnosis of diseases;
Domestic and foreign supportive research and data;
Qualified on-site inspection results.
5. Monitoring & evaluation
The holder of the registration certificate of health food with the new function shall formulate the post-marketing monitoring and evaluation plan; collect data such as product sales; consumer consumption, health evaluation and complaint feedback; carry out comprehensive analysis of consumer groups and health effects; and compile an annual self-examination report and submit it to the evaluation institution every year. Upon expiration of the monitoring period, if the monitoring and evaluation meets the requirements, the evaluation institution shall report the proposal, technical evaluation conclusions and other relevant materials to SAMR, and then SAMR officially incorporate the new function into the health function catalogue.
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