China Consults on Series of Health Food Related Documents, Involving Function Catalogue, Function Evaluation and Human Consumption Trial

On November 24, 2020, China State Administration for Market Regulation (“SAMR”) released a series of draft regulations related to health food functions for public comments, including:

• Health Function Catalogue Allowed for Health Food Claims  Non-nutrient Supplement (2020 Draft) (hereinafter as “the Catalogue”, the Catalogue includes the Evaluation Method for Health Food Functions)

• Interpretation of Health Functions (2020 Draft) (hereinafter as “the Interpretation”)

• Evaluation Guideline for Health Food Functions (2020 Draft)  (hereinafter as “the Evaluation Guideline”)

• Ethical Review Guideline for Health Food Human Consumption Trial (2020 Draft)  (hereinafter as “the Ethical Review Guideline”)

Comments should be submitted prior to December 23, 2020. Feedbacks regarding the Catalogue and the Interpretation should be sent to [email protected]. Comments on the Evaluation Guideline and the Ethical Review Guideline should be sent to [email protected].

Three functions removed from the allowed function claims

Compared with current 27 available functions, the three functions “promoting lactation, improving growth and improving skin lipid” are removed in the 2020 draft. There are now 24 functions left, and their definitions are added in the Interpretation. It is noteworthy that the Interpretation gives references on the health level of blood lipid, blood sugar and blood pressure. For example, a healthy index of Fasting Plasma Glucose should not be higher than 6.1 mmol/L.

The comparison of functions is as follows (changes highlighted in red):

The evaluation principles of health food functions are detailed

Evaluation Guideline for Health Food Functions specifies the primary requirements of health food function evaluation, animal testing, human feeding trial, and factors to consider while evaluating the products’ functions. Compared with its 2003 version, this draft details the basic requirements related to health food function evaluation and animal testing.

Here are some major amendments:

Basic requirements of heath food function evaluation

The enterprises need to provide more information of the tested samples, including the name, characters, specification, production date, shelf life, formula, processing technique and etc. In addition, the analysis report of potentially harmful substances for the tested sample is a new requirement.

In principle, the samples used for function evaluation, toxicological safety assessment, hygienic testing and prohibited substances detection should belong to the same batch. However, if it fails to use the same batch of samples due to the test period, the enterprises should ensure samples of the same batch are used for prohibited substances detection and human feeding trial, and offer the materials proving that product quality among different batches are the same.

The duration of animal and human feeding depends on the individual case, but in principle, it will last for 1 to 3 months.

Basic requirements of heath food animal testing

The latest draft stipulates that relevant information of feed manufacturers should be provided when it comes to the animal testing. In the case of customized feed, basic feed formula, preparation method, and animal feed testing report are all required.

Updates of function evaluation items and test methods

The Evaluation Method for Health Food Functions includes evaluation test items, test principles, test methods, and evaluation results. The 2020 draft provisions on whether animal test or human consumption test should be conducted upon evaluation of certain functions remain consistent with the 2003 Technical Standards for Testing & Assessment of Health Food.

However, the 2020 draft updates some test items and test methods from the 2003 Technical Standards. For example, for the function of anti-oxidation, there are more test items in the animal test in the 2020 draft. The test principles, results and test methods have also been updated accordingly.

Ethical Review Guideline for Health Food Human Consumption Trial (draft)

It is a new regulation specifying the ethical review work of health food human feeding trial. The institutions conducting human feeding trial should establish an ethical review committee, which is made of professionals having multiple academic backgrounds. The committee is obliged to have independent, objective, impartial and timely review of the human feeding trial project, and give the final assessment results.

The application materials for human consumption trial include but not limited to:

• Application form of ethical review (signature and the date)

• Letter of commitment (promise authenticity of the materials submitted)

• The program of health food human feeding trial (note the version number and date)

• Informed consent form (note the version number and date)

• Subject recruitment documents

• Specification of the tested products

• Log sheet of human feeding trial

• CV of the project leader and proving materials of ethic training (certificates, internal training record are both acceptable)

• Other relevant documents

• For premarket research, the applicant needs to provide: product’s R&D report, product formula, major manufacturing technique, technical requirements and inspection report of the tested product issued by qualified health food testing agencies (including but not limited to hygienic, safety evaluation and prohibited substance detection reports)

• For post-market research, the applicant needs to provide: analysis report of human consumption, selling certificates, product quality inspection report (including prohibited substances detection), enterprises credit report and etc.

The ethnical review will mainly check the following aspects:

• the safety of health food

• qualification of testing agency and researchers

• scientificity and compliance of the testing program

• risk and benefits

• subjects recruitment

• informed consent process and related document

• human subjects’ right to health and privacy

• protection to vulnerable population

• considerations on populations having specific diseases, populations from specific regions/ethnic groups

• conflict of interest

• other contents requiring inspection based on relevant laws and regulations.

The approval of human feeding trial project must conform to the following minimum standards:

• The testing agency and researcher are qualified

• Mandatory evaluation of the tested products such as hygienic and safety assessment have been finalized the results proved its safety and functions (only applies to premarket research)

• Corresponding risk control measures are taken

• The risks that subjects bear are reasonable to the expected benefits

• The selection of subjects is fair and impartial

• The information in informed consent form is comprehensive, and the process of obtaining agreement is legal

• There is data and safety monitoring plan to protect the safety of subjects if necessary

• There is specific solutions and compensation plan when test-related damage happens

• This program can well protect subjects’ privacy and data confidentiality

• There is special protection method when it involves the study of vulnerable group

• The program has considered possible conflicts of interests and formulated reasonable management scheme.

Impact on health food registration

Earlier in Oct. this year, SAMR published health food related technical guidelines for toxicological testing, bacterial strain testing and hygienic examination. As the core parts of health food technical assessment, the release of health food function evaluation guideline and human feeding trial ethnic review guideline in future will further complete the regulation framework of health food registration. In this case, the registration process can go forth more smoothly based on these regulatory references.

As it is highly likely that promoting lactation, improving growth and improving skin lipid will be removed from the function list in the final version, enterprises are recommended to refrain from applying for registration of products having these three functions. In principle, registered heath food with the functions mentioned above will fail to apply for registration renewal after the implementation of health food function catalogue, but it might still depend on the specific measures issued by the competent authority.

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