Index Number: 11100000MB0143028R/2025-810191

Document Number: No. 56 of 2025

Issuing Authority: Department of Special Food Safety Supervision and Administration

Date of Formulation: December 18, 2025

Date of Issuance: January 15, 2026

State Administration for Market Regulation, National Health Commission, National Administration of Traditional Chinese Medicine

In accordance with the provisions of the "Food Safety Law of the People's Republic of China" and its implementing regulations, the "Measures for the Administration of Health Food Raw Material Catalogues and Health Function Catalogues", and the "Detailed Rules for the Implementation of Technical Evaluation of New Functions and Products of Health Food (Trial)", the State Administration for Market Regulation, together with the National Health Commission and the National Administration of Traditional Chinese Medicine, has formulated the "Catalogue of Health Functions Permitted to be Claimed by Health Food - Contributing to Maintaining Bone and Joint Health (Relieving Pain or Stiffness/Relieving Cartilage Damage)" and supporting documents, which are hereby announced and shall come into force on January 1, 2026.

Name of Health Function：Contributing to maintaining bone and joint health (relieving pain or stiffness / relieving cartilage damage)

Remarks：Health function permitted to be claimed by health food (non-nutrient supplement)

Annex 1 Technical Guidelines for the Inspection and Evaluation of the Health Function of Contributing to Maintaining Bone and Joint Health (Relieving Pain or Stiffness/Relieving Cartilage Damage)

Section 1. Scope of Application

1. These Guidelines apply to the inspection and evaluation of the function of contributing to maintaining bone and joint health (relieving pain or stiffness/relieving cartilage damage), including the principles and recommended requirements for zoological function evaluation and/or human feeding test evaluation.

2. For specific proposals of new functions and product registration applications, applicants shall, based on the product characteristics and functional mechanism of action, conduct research in accordance with the relevant provisions such as the "Measures for the Registration and Filing of Health Food" and the "Detailed Rules for the Implementation of Technical Evaluation of New Functions and Products of Health Food (Trial)", and then put forward proposals for new functions of specific functional inspection methods and applications for the registration of new functional health food. Based on the evaluation results, scientific basis and academic consensus, the specific function claims shall be determined.

3. Applicants may use the test design project indicators recommended in this Catalogue, or propose research designs beyond the scope of these test principles, but they must provide sufficient scientific and reasonable explanations and put forward specific functional inspection methods.

Section 2. Functional Inspection and Evaluation Tests

The basic requirements for functional inspection and evaluation technology shall refer to the provisions of the "Technical Guidelines for the Inspection and Evaluation of Health Food Functions (2023 Edition)", including the basic evaluation requirements for animal tests and human feeding tests. In addition to the above basic requirements, the following issues shall also be paid attention to in the functional tests for contributing to maintaining bone and joint health:

1. Animal Tests

In principle, products containing new raw materials for health food shall conduct animal test evaluations. If the raw and auxiliary materials of the product formula are widely used in registered or filed health food, and there is sufficient scientific basis for the correlation between the formula compatibility, dosage and the declared function, an application for exemption from animal tests may be submitted. The key considerations for selecting animal tests include but are not limited to the following aspects: the edible history of raw materials, daily dosage, raw material compatibility alone or supplemented with related functions, and domestic and foreign literature on functional research. Animal tests are confirmatory studies to investigate the scientificity and reliability of product functions, as well as functional indicators that are not operable or ethically infeasible, and to explore the mechanism and biological basis of functional effects when necessary.

1.1 Test Models. The construction of animal test models shall be based on existing research results on bone and joint health, focusing on the evaluation of bone and joint health (relieving pain or stiffness/relieving cartilage damage). It includes drug-induced animal models of abnormal joint function and surgery-induced animal models of joint instability, with specific method details referring to authoritative literature, etc. The conditions for the establishment of animal models must be reproducible and evaluable, and clearly defined as necessary indicators for model construction. If the recommended models are not adopted, the reasons for selecting other animal models shall be explained with sufficient evidence support. Animal tests shall include the safety evaluation of raw materials or products. On the basis of not affecting the functional evaluation, indicators such as liver function, kidney function and targeted metabolism may be selected for observation.

1.2 Animal Grouping. The grouping of experimental animals shall fully consider key factors such as dosage design, balanced grouping, and the safe dosage range determined by toxicological evaluation. The animal grouping shall include 3 test sample dosage groups, a blank group (sham operation or sham drug group), a model group (operation group or drug group), and a positive control group may be set if necessary.

1.3 Test Indicators. Safety indicators and functional indicators.

2. Human Feeding Tests

2.1 Requirements for Subjects. Subjects are people with one or more manifestations of joint discomfort or functional limitation (such as knee joint pain, stiffness, limited mobility, etc.). The inclusion and exclusion criteria for subjects shall be determined based on age, joint symptoms, other disease conditions, scale scores and test compliance. The specific methods may refer to the basic requirements of the "Health Food Human Feeding Test (2023 Edition)" and comply with the ethical requirements of health food human feeding tests.

2.2 Test Design. Eligible subjects shall be based on randomized controlled trials (RCT), adopting double-blind, parallel or cross-over grouping. Except for gender, each group shall undergo balance test (or the grouping indicators shall remain basically balanced). The test group shall take the test product according to the recommended administration method and dosage, and a blank control group or a placebo control group may be selected. The number of subjects shall be determined based on the principle of meeting the statistical power requirements of RCT data. Generally, no less than 50 subjects shall be included in the analysis of each group, the total number of subjects at the end of the test shall not be less than 100, and the attrition rate shall generally not exceed 20%.

2.3 Determination of Observation Indicators. Including the safety and efficacy indicators of the product. The primary and secondary observation indicators shall be determined according to the specific claims of the function. Symptom signs, joint function, laboratory tests and other indicators shall be used to evaluate the product function. The evaluation shall mainly be based on scale scores, and other efficacy indicators and laboratory tests shall be used for auxiliary reference.

2.4 Strengthen Test Quality Control, Data Traceability and Management. Clarify the responsibilities of research applicants (units), test organizers (units) and research implementers (units). Select appropriate data recording and traceability technologies to ensure the scientificity and traceability of the research.

3. Result Determination and Corresponding Function Claims

3.1 Data Processing. Statistical analysis methods shall be selected according to the test design and data type.

3.2 Animal Tests. If the relevant test indicators of experimental animals in any test sample dosage group are not significantly lower than those in the blank group (sham operation group or sham drug group) and are significantly improved compared with the model group (operation group or drug group), the indicators shall be judged as positive.

3.3 Human Feeding Tests. Statistically analyze the differences in the selected indicators of the test group before and after the test, and between the test group and the control group after the test. If there are significant differences in both the self-comparison before and after the test and the inter-group comparison after the test, the indicators shall be judged as positive.

3.4 Function Claims. "Contributing to maintaining bone and joint health" is a first-level function claim. According to the results and determination of animal tests and/or human feeding tests, based on scientific basis and academic consensus, at least one second-level function claim shall be determined and marked in parentheses, such as: Contributing to maintaining bone and joint health (relieving pain or stiffness), Contributing to maintaining bone and joint health (relieving cartilage damage), Contributing to maintaining bone and joint health (relieving pain or stiffness and relieving cartilage damage), etc. Both animal test results and human feeding study results are the scientific basis for functional evaluation. The results of human feeding studies have a higher weight than animal test results and are the preferred scientific basis. For observation indicators that are not operable or ethically infeasible in human feeding tests, animal test results may be used as the main basis.

Annex 2 Test Items, Test Principles and Result Determination for the Evaluation of the Health Function of Contributing to Maintaining Bone and Joint Health (Relieving Pain or Stiffness/Relieving Cartilage Damage)

1. Function Name

Contributing to maintaining bone and joint health (relieving pain or stiffness/relieving cartilage damage)

1.1 Test Items

1.1.1 Animal Tests

1.1.1.1 Body Weight and Food Intake

1.1.1.2 Joint Pain/Mobility Indicators: Select appropriate methods to measure and evaluate joint pain/mobility, including but not limited to bipedal balance test.

1.1.1.3 Laboratory Indicators: Select appropriate joint tissue and functional biochemical indicators, including but not limited to inflammatory indicators (such as interleukin-6, interleukin-1β, TNF-α levels, etc.), matrix metalloproteinase 13 (MMP-13) detection, hyaluronic acid (HA) content, etc. At least 2 indicators shall be selected for determination among inflammatory indicators, and either matrix metalloproteinase 13 (MMP-13) or hyaluronic acid (HA) content shall be selected for determination. If other indicators are used, the basis for use and detection basis shall be provided.

1.1.1.4 Morphological Scoring and Histopathological Examination of Articular Cartilage

1.1.1.5 Safety Indicators: On the basis of not affecting the functional evaluation, select indicators such as liver function, kidney function and targeted metabolism to observe the safety of raw materials or products.

1.1.2 Human Feeding Tests

1.1.2.1 Clinical Symptoms and Signs: The changes in clinical symptoms and signs of bone and joint dysfunction are complex and subject to great subjective influence. Researchers shall fully communicate with subjects to evaluate the improvement effect on bone and joint health, and select appropriate methods to measure and evaluate joint pain or stiffness, including but not limited to patellar grind test.

1.1.2.2 Joint Mobility Indicators: Measure the flexion and extension degree and limited degree of the knee joint to evaluate joint mobility, including but not limited to goniometer test.

1.1.2.3 Laboratory Examinations: Including but not limited to bone metabolism biomarkers (such as serum type X collagen α1 chain COL10A1, serum type IIA procollagen N-terminal peptide PIIANP, CVX-II, cartilage oligomeric matrix protein) and inflammatory factors (such as interleukin-6, interleukin-1β, TNF-α levels), etc. The observation indicators of human feeding tests shall be determined according to the product formula, test research, literature basis and intended function claims. At least 2 indicators shall be selected for determination among bone metabolism biomarkers and inflammatory factor indicators respectively. If other indicators are used, the basis for use and detection basis shall be provided.

1.1.2.4 Scale Calculation: According to the applicant's own conditions, select but not limited to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC scale), KOOS scale or Japanese Knee Osteoarthritis Measure (JKOM scale). If other scales or self-designed scales are adopted, the reliability and validity test materials of the scales shall be provided, and their scientific rationality shall be explained.

2. Test Principles

2.1 Scientifically and reasonably select test items according to the product formula, test research, literature basis and intended function claims.

2.2 When determining the observation indicators of animal tests and human feeding tests, pay attention to their relevance, scientificity and rationality.

2.3 For those exempted from animal tests, the animal test evaluation indicators in the determination criteria shall not be required. Animal function tests must be carried out for the function of contributing to maintaining bone and joint health (relieving cartilage damage).

2.4 In the selection of laboratory examination indicators, research information on different mechanisms of bone and joint health improvement shall be considered. The indicators shall be complementary and mutually supportive, and in principle, 2 indicators shall be selected for the same type of indicators.

2.5 During the human feeding test, further observation and confirmation of the edible safety related to the function of the test sample shall be conducted simultaneously.

3. Result Determination

"Contributing to maintaining bone and joint health" is a first-level function claim. According to the results and determination of animal tests and/or human feeding tests, based on scientific basis and academic consensus, at least one second-level function claim shall be determined and marked in parentheses, such as: Contributing to maintaining bone and joint health (relieving pain or stiffness), Contributing to maintaining bone and joint health (relieving cartilage damage), Contributing to maintaining bone and joint health (relieving pain or stiffness and relieving cartilage damage), etc.

3.1 Contributing to maintaining bone and joint health (relieving pain or stiffness): Positive results in the bipedal balance test in animal tests (if applicable), positive results in any one of the laboratory indicators, positive results in scale calculation in human feeding tests, and positive results in joint mobility indicators.

3.2 Contributing to maintaining bone and joint health (relieving cartilage damage): Positive results in any one of the laboratory examination indicators and positive results in the morphological scoring and histopathological examination of articular cartilage in animal tests; positive results in scale calculation, positive results in any two of the laboratory examination indicators, and positive results in the improvement of patellar grind test in human feeding tests.

3.3 Contributing to maintaining bone and joint health (relieving pain or stiffness and relieving cartilage damage): Positive indicators for both sub-functional claims of contributing to maintaining bone and joint health (relieving pain or stiffness) and contributing to maintaining bone and joint health (relieving cartilage damage).

Reference

https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/tssps/art/2026/art_d1c641c2d2e345cea5f316b2c7826f61.html