The Technical Specifications for Testing and Evaluation of Health Food (2003 Version) was abolished in July 2018. After five years, on August 31, 2023, China’s State Administration for Market Regulation (SAMR) finally released the Directory of Health Functions Available to be Claimed by Health Food – Non-nutrition Supplements (2023 Version) and the supporting documents, including the long-awaited health food function evaluation methods.
These documents include:
- Directory of Health Functions Available to be Claimed by Health Food – Non-nutrition Supplements (2023 Version);
- Guidelines on Testing and Evaluation of Health Food Functions (2023 Version);
- Testing and Evaluation Methods for Health Food Functions (2023 Version);
- Guidelines on Ethical Review of Health Food Human Feeding Trials (2023 Version); and
- Interpretation to Directory of Health Functions Available to Be Claimed by Health Food – Non-nutrition Supplements (2023 Version) and the supporting documents.
Since August 31, 2023, registration of new health food products has officially started. CIRS will guide you through the key changes in the above-mentioned documents and summarize the testing requirements for registered health food products.
PART 1: Key changes in the five new documents
1. The total number of health functions has been reduced from 27 to 24, with revisions made to the wording used to describe the health claims.
Aligning with the earlier draft for public comment, the health claims allowed for functional health food have been reduced from the original 27 to 24. Three outdated functions, namely boosting lactation, promoting growth and development, and improving skin oiliness were formally removed. Moreover, revisions have been made to the wording for the remaining 24 health functions, making the terminology more standardized and precise. (See Table 1 for more details).
2. Although the overall requirements for function evaluation remain unchanged, there are still updates to the details.
Through comparison, we discovered that the requirements for conducting animal testing and (or) human feeding trials for the 24 health functions remain unchanged. For instance, the claim “aids in boosting immunity” still requires animal testing only; “contributes to anti-oxidation” still requires both animal testing and human feeding trials. However, there are still some differences, such as more testing programs and changes in the evaluation criteria.
It’s important to note that the new function evaluation methods have been shifted from mandatory to recommended.
3. The transition requirements for products approved previously are clarified.
– Products with health functions listed in the Directory: A five-year transition period is set to standardize the health claims. If the products are evaluated based on the methods recorded in the 1996 version, then related enterprises should redo or supplement functional tests (See Table 2 for details).
– Products with health functions not listed in the Directory: Apply for change of health functions or make declarations on the listing of their health functions within five years.
– Registration certificates with no valid period and no product technical requirements: Apply for change of certificates in accordance with current regulations in light of the situation.
Table 1 Comparison of the requirements for previous and new function tests
|S.N.||Previous health functions||New health functions (2023 Version)||Overall requirements for function tests (unchanged)|
|1||Enhancing immunity||Aids in enhancing immunity||Animal function tests|
|2||Anti-oxidation||Aids in anti-oxidation||Animal function tests and human feeding trials|
|3||Aids in improving memory||Aids in improving memory||Animal function tests and human feeding trials|
|4||Alleviating eye fatigue||Alleviating visual fatigue||Human feeding trials|
|5||Clearing the throat||Clear and nourish the throat||Animal function tests and human feeding trials|
|6||Improving sleep||Aids in improving sleep||Animal function tests|
|7||Alleviating physical fatigue||Alleviating physical fatigue||Animal function tests|
|8||Enhancing hypoxia tolerance||Tolerant to hypoxia||Animal function tests|
|9||Losing weight||Aids in controlling body fats||Animal function tests and human feeding trials|
|10||Increasing bone density||Aids in increasing bone density||Animal function tests|
|11||Improving nutritional anemia||Improving iron-deficiency anemia||Animal function tests and human feeding trials|
|12||Eliminating acne||Aids in eliminating acne||Human feeding trials|
|13||Eliminating skin chloasma||Aids in eliminating skin chloasma||Human feeding trials|
|14||Improving skin moisture||Aids in improving skin moisture condition||Human feeding trials|
|15||Regulating intestinal microbiota||Aids in regulating intestinal microbiota||Animal function tests and human feeding trials|
|16||Promoting digestion||Aids in promoting digestion||Animal function tests and human feeding trials|
|17||Relieving constipation||Aids in promoting regular bowel movements||Animal function tests and human feeding trials|
|18||Providing auxiliary protective function for gastric mucosal damage||Aids in protecting the gastric mucosa||Animal function tests and human feeding trials|
|19||Assisting in lowering blood lipids||Aids in maintaining healthy blood lipid (cholesterol/triglyceride) levels||Animal function tests and human feeding trials|
|20||Assisting in lowering blood sugar||Aids in maintaining healthy blood sugar levels||Animal function tests and human feeding trials|
|21||Assisting in lowering blood pressure||Aids in maintaining healthy blood pressure levels||Animal function tests and human feeding trials|
|22||Providing auxiliary protective function against chemical liver damage||Providing auxiliary protective action against chemical liver damage||Animal function tests|
|23||Providing auxiliary protective function against radiation hazards||Provides auxiliary protective action against ionizing radiation hazards||Animal function tests|
|24||Promoting lead excretion||Aids in lead excretion||Animal function tests and human feeding trials|
|26||Promoting growth and development||Removed||/|
|27||Improving skin oiliness||Removed||/|
Table 2. Correlation and function evaluation transition requirements for new and previous health claims
|S.N.||New health functions||Previous health functions||Function tests that need to be redone when the product evaluation was based on the Health Food Function Evaluation Procedures and Testing Methods (1996 Version)|
|1||Aids in enhancing immunity||Immunity regulation; enhancing immunity||Redo animal function tests|
|2||Aids in anti-oxidation||Delaying aging; anti-oxidation||Supplement human feeding trials|
|3||Aids in improving memory||Improving memory; aids in improving memory||If the wechsler memory scale is used in the human feed trial, redo human feed trial test according to the current regulations.|
|4||Alleviating visual fatigue||Improving eyesight; alleviating eye fatigue||—|
|5||Soothes and moistens the throat||Soothing and moistening the throat; clearing the throat||—|
|6||Aids in improving sleep||Improving sleep||—|
|7||Alleviating physical fatigue||Anti-fatigue; alleviating physical fatigue||If pole-climbing test is used in the animal test, redo animal test according to the current regulations.|
|8||Tolerant to hypoxia||Tolerant to hypoxia; enhancing hypoxia tolerance||Redo animal function tests|
|9||Aids in controlling body fats||Losing weight||Redo functional tests|
|10||Aids in increasing bone density||Improving osteoporosis; increasing bone density||—|
|11||Improving iron-deficiency anemia||Improving nutritional anemia; improving iron-deficiency anemia||—|
|12||Aids in eliminating acne||Beauty (eliminating acne); eliminating acne||—|
|13||Aids in eliminating skin chloasma||Beauty (eliminating skin chloasma); eliminating skin chloasma||—|
|14||Aids in improving skin moisture condition||Beauty (improving skin moisture/oil balance); improving skin moisture||—|
|15||Aids in regulating intestinal microbiota||Improving gastrointestinal function (regulate intestinal microbiota); regulating intestinal microbiota||—|
|16||Aids in promoting digestion||Improving gastrointestinal function(promoting digestion); promoting digestion||—|
|17||Aids in promoting regular bowel movements||Improving gastrointestinal function (promoting regular bowel movements); relieving constipation||—|
|18||Aids in protecting the gastric mucosa||Improving gastrointestinal function (providing auxiliary protective function for gastric mucosal damage); providing auxiliary protective function for gastric mucosal damage||—|
|19||Aids in maintaining healthy blood lipid (cholesterol/triglyceride) levels||Regulate blood lipid (reduce total cholesterol and lower triglycerides); assisting in lowering blood lipids||Redo human feeding trials|
|20||Aids in maintaining healthy blood sugar levels||Regulate blood sugar levels; assisting in lowering blood sugar||—|
|21||Aids in maintaining healthy blood pressure levels||Regulate blood pressure levels; assisting in lowering blood pressure||—|
|22||Providing auxiliary protective action against chemical liver damage||Has a protective effect against chemical liver damage; providing auxiliary protective function against chemical liver damage||—|
|23||Provides auxiliary protective action against ionizing radiation hazards||Radiation resistance; providing auxiliary protective effect against radiation hazards||Redo animal function tests|
|24||Aids in lead excretion||Promoting lead excretion||—|
|Note:Testing and Evaluation Methods of Health Food Functions (2023 Version) is a revision based on Technical Specifications for Health Food Testing and Evaluation (2003 Version) and the Announcement of 9 Health Function Evaluation Methods including Anti-oxidation issued by the former State Food and Drug Administration (SFDA) in 2012. No further re-evaluation materials for health functions is required if the evaluation requirements and standards of the original function test report are based on the above-mentioned two documents.In accordance with previous requirements for the re-registration of product health function evaluations, if the evaluation requirements and standards of the original function test report are lower than the current ones, corresponding health function re-evaluation materials must be provided when adjusting health function claims. It can be provided in two ways:A post-market population consumption function evaluation research report issued by a third-party testing organization. Data collection, management, and analysis should be standardized, truthful, and traceable, providing effective technical support for the product’s health functions.For those unable to provide such report, a function test report redone in accordance with the three documents ([1, 2, 3]) mentioned earlier can be provided. For those with original function test report evaluation requirements and standards aligned with the Health Food Function Evaluation Procedures and Methods (1996 Version), the requirements are outlined in Table 2. “–” indicates that no further health function re-evaluation materials required.|
PART 2: What tests are required for health food registration?
In July 2018, the Technical Specifications for Health Food Testing and Evaluation (2003 Version) was abolished, leaving no testing basis, thus hindering the registration progress. To address this issue, SAMR initiated a comprehensive revision to the regulations. So far, documents on toxicological assessment methods, sanitary physicochemical inspection standards, microbial safety assessments, and function evaluation methods, have been formally released. This has allowed health food registration and testing to officially resume.
Currently, when applying for health food registration, the following test reports need to be submitted:
|S.N.||Testing items||Basic requirements|
|1||3-batch self-tests||All technical indicators of the product’s technical requirements should be included.|
|2||3-batch tests of functional components or characteristic ingredients, hygiene, and stability||Ordinary samples typically undergo accelerated testing, with a general shelf life of two years. These samples should be stored for three months under conditions of 37±2℃, RH75±5%, and protected from direct sunlight. Sampling and testing should be conducted at zero, one, two, and three months. It is noteworthy that data from the zero-month assessment can be based on the results of hygiene testing performed on samples from the same batch.|
|3||Methodological validation on functional components or characteristic ingredients test methods||I. When referring to national standard methods, it is also necessary to assess the detection limit, precision, accuracy, and linear range of the method;II. Currently, the methodological research data for probiotic-like signature component testing is not considered a mandatory requirement.|
|4||Toxicology tests||I. These typically include: acute oral toxicity tests, three genetic toxicity tests, and 28-day oral toxicity tests;II. The testing should be conducted in the same laboratory as the functional tests, using the same batch of samples, and one of the batches used for stability testing.|
|5||Animal function tests and (or) human feeding trials||The toxicological testing should be carried out in the same laboratory as the functional tests, using the same batch of samples, and one of the batches used for stability testing.|
|6||Other tests, if necessary (depending on the specific product, such as strain identification, and strain virulence test).||/|
(Source: CIRS Group)
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