Following SAMR’s release of the 2023 Directory of Health Functions for Health Food (non-nutrition supplements), registrants must update outdated health claims to match the latest wording and evaluation requirements. Many certificate holders, especially those registered under the former MOH, may also need to redo or supplement function tests to obtain a new certificate within the 5-year transition period. In this article, we have compiled the common FAQs to help companies better fulfil their obligations. You can find Vol 1 here.
Q1. After removing raw materials without supporting evidence or those exceeding the number specified in Annex 2 of 卫法监发 [2002] No.51, can the daily dosage of the remaining raw materials be increased? Is replacement of functions allowed, and if so, is submission of only a functional test report acceptable, or is scientific literature support also required?
A1. According to Key Points for Centralized Review of License Renewal for Health Foods “Without Expiration Date and Without Product Technical Requirements” in Production and on the Market (“Section V Specific Requirements”), registrants who adjust product formulas (including replacement or removal of raw materials) in accordance with current regulations must submit R&D materials in line with new product registration requirements. These include the product formula, production process, draft label and instructions, product technical requirements, as well as test reports on safety, health functions, hygiene, stability, and efficacy/marker component testing, in order to demonstrate the product’s safety, claimed health functions, and quality controllability.
Q2. If the raw material used is included in the Health Food Raw Material Catalogue but the product claims two functions, one of which is inconsistent with the catalogue, and functional tests have been conducted as required with positive results, can both functions be retained through renewal application? Would the product be required to switch to filing?
A2. The Food Safety Law stipulates that the Health Food Raw Material Catalogue shall include the raw material name, dosage, and its corresponding function; health foods using raw materials outside the catalogue or imported for the first time must be registered with the State food safety regulatory authority. Therefore, if the functional claim is inconsistent with the catalogue but has sufficient scientific evidence, registration is required by law, and both functions may be retained. As registration data accumulates and the functional claims of raw materials in the catalogue are expanded, such products will then be included under the filing system.
Q3. For the same product, if functional verification and toxicological verification are conducted with different daily intake designs, and the daily intake used in functional tests is lower than that in toxicological tests, the proposed daily consumption is set as a range (e.g., 2–4 capsules/day). Is this acceptable?
A3. Functional and toxicological evaluation tests for health foods are validation tests and are not the sole basis for determining the recommended daily intake. Applicants should comprehensively consider formulation design theory, scientific literature, and the benefit-risk ratio of ingredient combinations to establish a clear and optimal recommended daily intake. It is not advisable to label the intake as a range value.
Q4. If the originally registered process involved the enterprise purchasing raw materials and producing extracts in-house, can the raw material be changed to “extracts” through license renewal?
A4. According to the Detailed Rules for the Review and Approval of Health Food Registration and the Health Food Registration Application Service Guide, product formula raw materials and their dosages shall not be changed, except where changes in current regulations or mandatory standards render the registration certificate and its attachments non-compliant. If the proposed change results in a substantive alteration of product quality, or if sufficient justification cannot be provided, the review conclusion will be “recommendation not to register.” The Key Points for Centralized Review of License Renewal for Health Foods “Without Expiration Date and Without Product Technical Requirements” in Production and on the Market also stipulates that provincial market regulatory authorities shall issue renewal opinions based on actual production and supervision, including production license status, complete formula, production process, product technical requirements, and conclusive opinions.
Therefore, the formula for license renewal must be the one reviewed and confirmed by the provincial authority, consistent with the formula actually used in production. Except where changes in current regulations or mandatory standards render the existing certificate and attachments non-compliant, product formula raw materials and their dosages shall not be altered. Hence, raw materials cannot be changed to extracts through license renewal.
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