CIRS FAQ: Is It Necessary to Establish Animal Function Evaluation Methods while Applying for New Health Functions? Vol. 01, 2024

From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on health food to help you gain a clearer understanding of the current requirements in China.

Q1: What are the specific size requirements for the “blue hat” sign of health food products?

A1: It is specified in the Guidelines for Standardized Labeling of Health Food Signs that health food signs, commonly known as the blue hat, shall follow the following labeling requirements:

• If the main display area of the smallest sales packaging for health food is over 100 cm2, the width of the sign at its widest point shall be no less than 2 cm. If it’s 100 cm2 or less, the width shall be no less than 1 cm;
• The overall ratio ion of the sign is set at 8.2:12 (height: width), with the hat-shaped pattern’s height being 6.6 units, the width being 12 units, and the diameter of the central sphere being 3.8 units;
• The width of the four characters “保健食品” (health food) is 8.2 units. Among these, “保”, “健” and “食” all have a height of 1.8 and a width of 1.9, while “品” is slightly smaller, with a height of 1.7 and a width of 1.85; and
• The standard printing color for the sign is CMYK with values C100 M0 Y0 K0, and the screen standard color is RGB with values R0 G160 B233.

Q2: What are the dosage form requirements for Ginseng radix et rhizoma, Panacis quinquefolii radix and Ganoderma, three newly added raw materials to the Directory of Health Food Raw Materials, when used to produce health food?

A2: On February 8, 2024, the State Administration for Market Regulation (SAMR) issued the drafted Technical Requirements for Filing Products with Health Food Raw Material Ginseng radix ET rhizome, Panacis quinquefolii radix, and Ganoderma, specifying the dosage form requirements regarding filing products as follows:

• General requirements: When filing single-ingredient products with Ginseng radix et rhizoma, Panacis quinquefolii radix and Ganoderma, permissible dosage forms include tablets (including regular tablets, chewable tablets, and oral tablets), hard capsules, soft capsules, powders, oral liquids, mixtures, granules, ointments, and tea products (packaged tea products);
• For products produced using dosage forms not listed above, additional requirements apply. For example, if a dosage form for a registered product containing similar ingredients already exists, the applicant should justify the necessity, scientific validity, and rationality of choosing that dosage form, based on approved registered health food products containing similar ingredients. Additionally, the basis for establishing quality control indicators and safety shall also be provided.

Note: The above information is for reference only. Please refer to the official document for the final requirements.

Q3: During the application process, is it necessary to present literature where all ingredients of a formula are combined? Is literature supporting pairwise or triple combinations not available as the literature basis?

A3: It is generally recognized as challenging to find literature where all ingredients of a complex formulation are combined. However, literature supporting pairwise or triple combinations between the main ingredients can still be valuable. It to some extent supports the efficacy of the product formulation and can be utilized as a reference during the application process.

Q4: Is it necessary to establish animal function evaluation methods while applying for new health functions?

A4: It is specified in the Implementation Rules for Technical Evaluation of New Functions and Products of Health Food (Trial) that new function evaluation methods research and methodological validation shall be thoroughly conducted. In principle, human feeding trials shall be included.

The established evaluation methods shall comply with the requirements outlined in the Guidelines on Testing and Evaluation of Health Food Functions (2023 Edition), and human feeding trials should generally be conducted on the premise of effective animal function tests.

Therefore, when companies research new health food function evaluation methods, animal function evaluation methods are typically established.

Q5: After passing the on-site inspection for health food registration, is another inspection required if supplementary materials are submitted?

According to the health food registration process, the Center for Food Evaluation (CFE) first conducts a technical review of the application dossiers. If corrections are needed, another technical review is conducted after the submission of supplementary materials. Upon completion of the review, if the dossier is deemed compliant, on-site inspections and retesting are carried out as needed. Therefore, supplementary materials are typically submitted prior to the on-site inspection.

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

Further Information

CIRS FAQ: Can Approved New Food Raw Materials Be Used in FSMP? Vol. 02, 2024

CIRS FAQ: Can Different Companies Use the Same Formula to Apply for Heath Food Filing? Vol. 3, 2024

CIRS FAQ: Which FSMP are Eligible for Inclusion in the Priority Review and Approval Process? Vol. 4, 2024