SAMR Issued the Draft on Adjusting the Health Function of Health Food - Regulatory News - Food & Food Contact Materials

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In order to strengthen the management of health function claim, SAMR issued a draft on ‘adjusting the health function of health food’ for public comment on 28 March 2019. Opinions and advices shall be given before 28 April 2019.

1. Health functions proposed to be adjusted

I. Please refer to table 1 for the health functions proposed to be adjusted.

II. After the health functions are officially adjusted, the function expression on the labels and instructions can be modified directly without applying for registration change. The listed products can be sold until the expiration of the shelf life. For products in the process of review, the review body will directly adjust their functions so that the applicants do not need to make corrections by themselves.

Table 1 Health functions proposed to be adjusted

S.N.	Former Health Function Name	Adjusted Health Function Name
1	Regulating immunity/Enhancing immunity	Beneficial to enhancing immunity
2	Antifatigue/Alleviating physical fatigue	Alleviating physical fatigue
3	Antioxidation	Beneficial to antioxidation
4	Improving osteoporosis/Increasing bone density	Beneficial to facilitating bone health
5	Improving gastrointestinal function (moistening the intestines and facilitating feces excretion)/Facilitating feces excretion	Beneficial to moistening the intestines and facilitating feces excretion
6	Improving gastrointestinal function (regulating gastrointestinal tract flora) /Regulating gastrointestinal tract flora	Beneficial to regulating gastrointestinal tract flora
7	Improving gastrointestinal function (facilitating digestion) /Facilitating digestion	Beneficial to facilitating digestion
8	Improving gastrointestinal function (assisting the protection of gastric mucosa) /Assisting the protection of gastric mucosa	Assisting the protection of gastric mucosa
9	Improving hypoxia tolerance	Improving hypoxia tolerance
10	Losing weight	Beneficial to regulating body fat
11	Beautifying (eliminating skin chloasma) /Eliminating skin chloasma	Beneficial to improving skin chloasma
12	Beautifying (Eliminating acne) /Eliminating acne	Beneficial to improving acne
13	Beautifying (improving skin moisture/oil content) /Improving skin moisture content	Beneficial to improving skin moisture content
14	Improving memory/Assisting memory improvement	Assisting memory improvement
15	Clearing and moistening throat /Clearing throat	Clearing and moistening throat
16	Improving nutritional anemia / Improving iron deficiency anemia	Improving iron deficiency anemia
17	Improving eyesight/Alleviating eye fatigue	Alleviating eye fatigue
18	Sleep Improvement	Beneficial to improving sleep

2. Health functions proposed to be cancelled

I. Please refer to table 2 and table 3 for the health functions proposed to be cancelled.

II. When the following health functions are officially cancelled, the production of relevant products shall be immediately stopped. The health food which was already produced, can be sold until the end of the shelf life if they do not involve quality and safety problems. Furthermore, SAMR shall no longer accept the application of these health functions.

Table 2 Existing health functions proposed to be cancelled

S.N.	Former Health Function Name
1	Beautifying (improving skin oil content) / Improving skin oil content
2	Facilitating child growth / Improving child growth
3	Promoting lactation

Table 3 Health functions which were approved in the past but no longer accepted currently and proposed to be cancelled (Include but not limited to the following functions)

S.N.	Former Health Function Name
1	(Assisting) Inhibiting of Tumors
2	Antimutagenicity
3	Improving sexual function
4	Regulating immunity only
5	Regulating blood lipids only
6	Improving microcirculation
7	Beautifying (Breast enhancement)
8	Preventing seborrheic alopecia
9	Improving intestinal peristalsis
10	Blocking the synthesis of N-nitroso compounds
11	Tooth protection
12	Promoting hair growth
14	Increasing amount of leukocyte
13	Preventing juvenile myopia
15	Balancing skin acidity and alkalinity
16	Reducing sebaceous gland secretion
17	Reducing wrinkles
18	Beautifying (Alleviate skin damage caused by ultraviolet radiation)

3. Health functions need to be further studied

Please refer to table 4 for the health functions need to be further studied.

Table 4 Health functions need to be further studied

S.N.	Former Health Function Name
1	Assisting blood lipids reduction
2	Assisting blood sugar reduction
3	Assisting blood pressure reduction
4	Auxiliary protection against chemical injury of liver
5	Auxiliary protection against radiation hazards
6	Alleviating lead excretion

CIRS comments

SAMR pays more and more attention to the publicity of health food. We think it is very likely that Chinese authority will not change the final decision on the functions listed in table 1, 2 and 3. In addition, please note that once the functions listed in table 2 and table 3 are formally cancelled, all the registration certificates with such functions will be invalid, which means that the enterprises cannot produce or sell the health food again on Chinese market, even the products had been approved before.

Table 4 includes several common functions, such as assisting blood lipids reduction, assisting blood sugar reduction and assisting blood pressure reduction, etc. The main reason for why these functions are listed to be further studied is that, they are similar to disease treatment, and it is easy to make false propaganda. Therefore, before being officially announced, enterprises preparing new products are advised to avoid the application of the functions listed in table 4.

If you have any needs or questions, please contact us at service@cirs-group.com.

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