FAQs on the Replacement of Health Food Registration Certificate in China (Vol. 3)

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release of the 2023 Directory of Health Functions for Health Food (non-nutrition supplements), registrants must update outdated health claims to match the latest wording and evaluation requirements.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 also see Vol. 1, and Vol. 2.

Q1. When formulating product technical requirements, which indicators need to be added or revised?

A1. According to 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 and other relevant regulations, registrants should develop product technical requirements based on filed or publicly disclosed enterprise standards that comply with current regulations and national standards. For indicators that do not conform to current regulations and national standards, corresponding additions or revisions shall be made. For other indicators that applicants intend to change, it is recommended to first complete the “double-no” license renewal, and then submit a change registration application.

Q2. When formulating product technical requirements, how should test reports and related materials be submitted if adding or revising physicochemical, microbiological, or efficacy/marker component indicators?

A2. According to 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, when adding or revising physicochemical, microbiological, or efficacy/marker component indicators, only the hygienic or stability test reports for the newly added or revised indicators are required. Full test reports covering all indicators in the product technical requirements are not necessary. For stability key indicators, stability test reports must be provided; for non-stability key indicators, hygienic test reports must be provided. Reference may be made to the Technical Guidelines for the Inspection and Evaluation of Physicochemical and Hygienic Indicators of Health Foods (2020 edition) regarding stability and non-stability key indicators.

Q3. Under what circumstances should excipients in the product formula be adjusted?

A3. Excipients in health foods refer to carriers and other auxiliary materials used in production, including foods, food additives, and commonly used pharmaceutical excipients. Their essential role is to meet process requirements in product manufacturing. Excipients used in health foods must have a clear basis for use and comply with current regulations. When regulatory standards are updated, the excipients in product formulas should be re-confirmed. If adjustments are necessary, applicants should provide relevant materials in accordance with Section 8 “Items and Requirements for Change Registration Application Materials” of the Service Guide for Health Food Registration Application (2016 edition). For other intended adjustments to excipients, it is recommended to first complete the “double-no” license renewal, and then submit a change registration application.

Q4. What should be noted when establishing sensory requirement indicators for health foods?

A4. Sensory requirements should generally include product appearance (such as color and form) and the color, taste, odor, and form of the contents.

Color should be clearly described, and a defined range may be specified, but cross-color series descriptions should be avoided. Typically, a sequence from light to dark should be used, e.g., “yellow-brown to brown.” For composite colors, the auxiliary color should be listed first, followed by the primary color, e.g., “yellow-brown,” meaning primarily brown with yellow as secondary. Taste and odor should be clearly described. For state, if the product belongs to a dosage form included in the Pharmacopoeia of the People’s Republic of China (2025 edition), the description of its state may be made by reference to the Pharmacopoeia. If it belongs to a food form, reference may be made to relevant national standards for food. The description should also include reference to impurities (e.g., “free from visible foreign matter to the naked eye”). Requirements and examples are as follows:

Dosage Form	Requirements and Examples
Hard Capsules	Color: Should describe the color of the capsule contents. No requirement for the capsule shell color. Example: contents are yellowish-brown. Form/State: Should describe the integrity and appearance of the capsule and contents. Example: hard capsules are intact, without adhesion, deformation, leakage, or cracks; contents are granules or powder.
Soft Capsules	Color: Should separately describe the color of the capsule shell (or outer shell) and the contents. Example: capsule shell is yellow-brown (shell is translucent), contents are yellowish-brown. Form/State: Should describe the integrity and appearance of the capsule shell and contents. Example: soft capsules are intact, without adhesion, deformation, leakage, or cracks; contents are oily liquid/oil suspension/semi-solid paste/suspension.
Coated Tablets	Color: Should separately describe the color of the coating and the tablet core. Example: coating is transparent (light blue), tablet core is yellowish-brown, with uniform color. Form/State: Should describe the form of the coated tablet. Example: film-coated tablet (sugar-coated tablet) is complete, smooth, glossy, and has appropriate hardness.
Granules	Form/State: Should describe the form of the granules. Example: granules should be dry, uniform, free of moisture absorption, caking, or dissolution phenomena.
Oral Liquids	Form/State: Should describe the form of the oral liquid. Example: clear liquid, no fermentation, rancidity, discoloration, gas production, or other abnormal changes; a small amount of easily dispersible sediment is allowed.
Tinctures/Alcohol-based Preparations	Form/State: Should describe the form of the preparation. Example: clear liquid, a small amount of easily dispersible sediment is allowed.
Powders	Form/State: Should describe the form of the powder. Example: powder is dry, loose, uniformly mixed.
Pills	Form/State: Should describe the form of the pills. Example: pills are round and intact, uniform in size, without adhesion phenomena.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

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