China Consults on Health Function Catalogue for Health Food (2022) and Other Supporting Documents

As per Food Safety Law, China implemented the catalogue management system for health food functions, and released the corresponding Administrative Measures to regulate the formulation process, inclusion criteria and adjustment of health food functions in 2019. Later in 2020, China State Administration for Market Regulation (SAMR) released Health Function Catalogue Allowed for Health Food Claims Non-nutrient Supplement (2020 Draft) (hereafter referred to as the Catalogue) and a series of supporting documents for public comments. On Jan. 13, 2022, SAMR opened the new drafts of the Catalogue and four supporting documents for public feedback. Any comments can be sent to [email protected] prior to Feb. 12, 2022. 

Major Contents Revealed by the Drafts  

Function Catalogue Allowed for Health Food Claims Non-nutrient Supplement (2022 Draft)

The 2022 Catalogue removed three health food functions, namely, "promoting lactation", "improving growth" and "improving skin lipid" from the current 27 allowed functions, as in 2020 Catalogue. The other 24 health food functions were still included in the 2022 Catalogue with slight modifications in the descriptions. For specific revisions, please refer to Table 1 below.

Interpretation of Health Functions (2022 Draft) (hereafter referred to as the Interpretation)

The interpretation introduced the 24 health functions from three aspects, that is, physical or healthy effect of functions, other factors or conditions that influence the effect of functions, as well as current scientific understanding and limitation. For example, the function “helping enhance immunity” is interpreted as “Immunity is the ability of the human body to maintain a stable response to external defense and internal environment, which is affected by many factors. Malnutrition, fatigue, lack of physical activity and irregular routine can lead immunity to reduce. Attention should be paid to adjusting and correcting these factors. Scientific research shows that supplementing appropriate substances helps improve immunity.”

Evaluation and Testing Method for Health Food Functions (2022 Draft) (hereafter referred as the Method)

The Method provides the evaluation and testing method for each health food function. Compared with the 2020 draft, it is noticeable that all methods stated in the new draft should be regarded as recommended methods rather than mandatory methods. For the inclusion procedure of new evaluation methods for health functions in the Method, please refer to the inclusion procedure of the Catalogue. Once a new method gets approved as a recommended method in the Method, it is valid to be used for product registration. 

Technical Guideline for Evaluation and Testing of Health Food Functions (2022 Draft) (hereafter referred to as the Technical Guideline)

In order to clarify the basic principle of the evaluation of health food functions, the Technical Guideline applies to the evaluation and testing for health functions, including animal and human experiments. It also lists the factors need to be taken into account when conducting functional evaluations. For example, when determining the intake, in addition to common groups, considerations for special groups (children, pregnant woman and groups with high intake, etc.) should also be given. 

Ethical Review Guideline for Health Food Human Consumption Test (2022 Draft) (hereafter referred to as the Ethical Review Guideline)

Compared with the 2020 draft, the new Ethical Review Guideline keeps most contents without substantial changes. It specifies the ethical review work of human feeding trial for health food. For more details, please check ChemLinked News. 

Clarified Administrative Measures for Health Foods Under Different Statuses 

1. For health foods whose functions are listed in the Health Food Function Catalogue 

The updated Health Food Function Catalogue will come into effect on the promulgation date. For products whose function claims need to be adjusted as listed in the table below, health food manufacturers shall revise the function claims and corresponding descriptions displayed on the product label and packaging as well as in the instruction. Besides, for products whose function evaluation were conducted as per the evaluation procedure and test methods released before 2003 (including but not limited to the methods released in 1996), manufacturers should also redo or complete the function experiment according to the new provisions or provide the function test report which was conducted based on the evaluation methods released in 2003 or 2012.

Table 1 Adjusted Functions and Required Experiments

1.1 If manufacturers need to redo or complete the experiments 

For manufacturers who need to redo or complete more experiments (as per the table above), they should apply for alteration registration. A new registration certificate will be released accordingly.

If the above health foods have already been circulating in the market, manufacturers can provide a report on the function evaluation of human consumption issued by a third-party test agency as a supporting material of the claimed functions.

1.2 If manufacturers do not need to redo or complete more experiments 

In many cases, for example, if products intend to  change the function claim from "Relieving eye fatigue" or "Advancing eyesight" to "Relieving visual fatigue" (as listed in the table above), manufacturers do not need to redo or complete more experiments. In this case, manufacturers don't need to apply for alteration registration (for applications that have already been submitted to the authority, the review agency will directly help adjust the function claim, etc.,). Health foods that have already been on the market can be sold till the expiration date.

2. For health foods whose functions are not listed in the Health Food Function Catalogue or canceled 

2.1 For products whose function claims are canceled 

This draft canceled 7 function claims that were approved previously, including 3 functions claims that were listed in the current 27 functions and 4 functions approved by the former Ministry of Health. They are "promoting lactation", "improving growth", "improving skin lipid", "suppressing tumor", "helping suppress tumor", "anti-mutagenic" and "anti-aging". Moreover, these 7 functions will no longer be added into the function catalogue.

For such products whose function claims are all canceled, applicants can apply for the alteration of product functions as per Administrative Measures for Registration and Filing of Health Foods. 

At latest on the promulgation date of the official notice, manufacturers should stop the production of health foods bearing the 7 function claims. Health foods that have already been produced can be sold till the expiration date. 

2.2 For products whose function claims are not canceled but not listed in the function catalogue 

Besides the 7 canceled functions, there are also some function claims that are neither be canceled nor listed in the function catalogue, such as the claim "advancing microcirculation" which was approved previously by the Ministry of Health. 

In this case, manufacturers should adjust the functions of such products and follow the new evaluation requirements as listed in the table above. For products that cannot be adjusted accordingly, applicants can propose to add new functions into the Health Food Function Catalogue. 

ChemLinked Interpretation 

It is worth noting that manufacturers shall stop the production of health foods (except health foods with canceled functions) whose functions are still inconsistent with the Health Food Function Catalogue after five years since the promulgation date of the official notice. 

Once the draft is approved, it will greatly influence the Chinese domestic health food market for many domestic health foods are still bearing the function claims approved by the former Ministry of Health. China's health food market is expected to be further standardized in accordance with this notice.