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.
Q1: According to the Directory of Health Functions Available to Be Claimed for Health Food - Non-nutrition Supplements (2023 Version), how shall I fill out the health function section in the application form?
A1: For new product applications, it is advised to align with the new directory; for applications of change, renewal, transfer, and re-issuance, it shall be consistent with the health function detailed in the approved certificate.
Q2: Is it still necessary to obtain a paper version of the acceptance notice for health food?
A2: Currently, applicants can receive an electronic version of the acceptance notice on the upgraded Health Food Registration Management Information System. Therefore, applicants submitting dossiers in person can choose not to collect a paper version. Likewise, the acceptance office will no longer send out the paper version for dossiers submitted via mail.
In the case of special circumstances requiring the collection or mailing of a paper version, applicants are required to provide relevant details along with the dossiers.
Q3: What are the requirements for the scientific basis of health claims in the Health Food Function Demonstration Report?
A3: It demands a comprehensive and well-structured presentation of scientific evidence, including the sources, contents, and full text of the scientific basis. This should be coupled with sufficient elaboration on the scientific basis of the product's formulation and its functional claims through detailed comparative research with the product's formulation and processes, among others. Literature references shall consist of research papers formally published in domestic core professional journals or international equivalents, relevant records in traditional Chinese pharmacopeias, literature analysis, evaluation reports, and internationally recognized food safety authorities or organizations. Official publications of international standards, national standards, risk assessment reports, and statistical information by relevant departments or authoritative bodies in China are also deemed essential. The compiled information shall be complete and accurate, providing effective support for the product's formulation and its functional claims. Information from newspapers, online reviews, non-scientific journals, patent documents, product promotional materials, and similar sources not included in domestic core professional journals is considered invalid and is not within the scope of review.
Applicants are encouraged to comprehensively and systematically search and screen relevant literature for the functional basis of the main ingredients in the product's formulation and the necessity of compatibility with other ingredients. It is recommended to utilize the Meta-analysis method for a systematic literature analysis and provide a literature analysis and evaluation report on the sufficiency of the scientific basis and rationality of the product's formulation.
Q4: What are the requirements for the bibliography summary table in the Health Food Function Demonstration Report?
A4: It shall include the title, first author, indication of whether the publication is a core journal, composition of the test substances, main components, processing technology, animal or human models and grouping, test doses, and equivalent human doses (including dose conversion basis), evaluation indicators, test results, and conclusions. The specific requirements are outlined in the table below.
Full title of the literature
Full name of the first author
Name of the publication, specific publication year, volume, page numbers, etc. For Chinese literature, it shall be noted whether it is a core journal.
Composition of the test substances
Names of the test substances, and if it’s a compound, all components shall be listed. List any specific proportions or quantities. In cases involving extraction processes, the extraction rate shall be indicated. The demonstration report elaborates on the scientific rationale for the selection and compatibility of each ingredient in the product’s formulation based on this information.
The explicitly identified effective components in the literature. The demonstration report, based on this information, elaborates on the scientific rationale for the compatibility of ingredients in the formulation, the determination of characteristic ingredients or functional components, and their relevance to the declared functions.
The manufacturing and processing process of the test substances, as well as the treatment methods used in the experiments. The demonstration report, based on this information, elaborates on the processing requirements for raw materials, the scientific rationale behind the product’s process design, and its relevance to the declared functions.
Animal or human models and grouping
The selection of test subjects and specific grouping details. The demonstration report, based on this information, elaborates on the scientific rationale behind the selection of the test population and the applicability of functional evaluation test validation.
Test doses, equivalent human doses (including dose conversion basis)
The recommended doses for test animals and humans, the relationship between the two, and the basis for the calculations. In conjunction with the selection of test subjects and the composition of the formulation, the demonstration report determines the scientific rationale for the selection of ingredient quantities and their relevance to the declared functions.
The evaluation indicators used in the tests. The demonstration report, based on this information, discuss the scientific rationale for the selection and combination of ingredients in the product's formulation, the basis for compatibility, and its relevance to the declared functions and their evaluation methods.
Test results and conclusions
A brief description of the test results and conclusions. The demonstration report elaborates on the scientific rationale for the selection of each ingredient in the product’s formulation, the determination of their compatibility and composition, and their relevance to the declared function.
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