New Methods for Functional Assessment of Health Food (Drafts) Issued in China - Regulatory News - Food & Food Contact Materials

On November 24, 2020, SAMR released 4 drafts about the permitted health functions and the corresponding evaluation methods for functional health food in China, advice and opinions on them shall be given before December 23, 2020.

The drafts include,

<List of Health Functions Available for Health Food, Except Nutrition Supplement (2020 version, draft)>, which includes the <Methods for Functional Assessments of Health Food(2020 version, draft)>;
< Interpretation on Health Food Function Claims (2020 version, draft)>;
< Guidelines for Functional Assessment of Health Food (2020 version, draft)>; and
< Guidelines for Ethical Review of Human Feeding Trials on Health Food (2020 version, draft)>.

1) Big changes: the permitted health functions are reduced from 27 to 24, and the expressions of functions are revised.

As is known to all, 27 health functions were available for functional health food in China. According to the new draft, however, 3 functions including “facilitating milk secretion”, “improving child growth”, and “improving skin oil content” will be removed, and the other 24 functions will be revised as well to make the expressions more accurate and more scientific.

Comparison of the old and the new health functions is shown in the table below.

S.N.	Old functions	New functions (draft, 2020 version)
1	Enhancing immune	Function that helps to enhance immune
2	Anti-oxidative	Function that contributes to anti-oxidation
3	Assisting memory improvement	Function of assisting memory improvement
4	Alleviating eye fatigue	Function of alleviating eye fatigue
5	Clear the throat	Clear and nourish the throat
6	Sleep improvement	Function that helps to improve sleep
7	Alleviating physical fatigue	Function of alleviating physical fatigue
8	enhancing anoxia endurance	Function of anti-anoxia
9	Reducing body weight	Function that helps to regulate body fat
10	Increasing bone density	Function that helps to increase bone density
11	Improving malnutrition anemia	Function of improving iron-deficiency anemia
12	Eliminating acne	Function that helps to eliminate acne
13	Eliminating skin chloasma	Function that helps to eliminate skin chloasma
14	Improving skin water content	Function that helps to improve skin water content
15	Regulating gastrointestinal tract flora	Function that helps to regulate gastrointestinal tract flora
16	Facilitating digestion	Function that helps to facilitate digestion
17	Facilitating feces excretion	Function that helps to embellish aperient bowel
18	Assisting the protection from gastric mucosal injury	Function of assisting the protection of gastric mucosa
19	Assisting blood lipids reduction	Function that helps to maintain healthy blood lipid levels (cholesterol / triglycerides)
20	Assisting blood sugar reduction	Function that helps to maintain healthy blood sugar levels
21	Assisting blood pressure reduction	Function that helps to maintain healthy blood pressure levels
22	Assisting the protection from chemical liver injury	Function of assisting the protection from chemical liver injury
23	Assisting protection from irradiation hazard	Function of assisting protection from ionizing radiation hazard
24	Alleviating lead excretion	Function that helps to alleviate lead excretion
25	Facilitating milk secretion	Will be removed
26	Improving child growth	Will be removed
27	Improving skin oil content	Will be removed

2) The requirements on functional assessment remain unchanged, while the details of the methods are updated

The functional assessment includes animal test and (or) human feeding trials, depending on the specific health functions. Compared with the old version, the requirements on animal test and (or) human feeding trials remain unchanged for the 24 health functions. For example, it is still required to carry out animal test for the function that helps to enhance immune, and animal test and human feeding trials are still required for function that contributes to anti-oxidation. On the other hand, the new methods are updated in some details, such as the addition of certain test items and changes in evaluation indicators.

3) Add the interpretation on health food function claims

It is the first time China releasing the interpretation of the 24 health functions for functional health food. The interpretation is an effective way to help consumers understand the health functions correctly and avoid misunderstanding on health food of having functions to prevent or treat diseases.

In the end

<Technical Standards for Testing & Assessment of Health Food (2003 version) > was abolished in July, 2018. Due to this situation, many enterprises suspended the registration tests of new products. In this year, the guidelines on toxicological test, and hygienic and physicochemical inspection for health food have been officially issued and implemented. The functional assessment methods released this time are the test methods with the most concerns, and we believe that they will be implemented in the near future.

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