On 13 February 2018, former CFDA issued a Notice on Standardizing the Function Claims of Health Food (hereinafter referred to as the Notice), and the State Administration for Market Regulation (SAMR) interpreted the relevant matters of the Notice on 17 April 2018.
1. Details of the Notice
I. For the health food that have not been evaluated by human feeding trials, the words of “本品经动物实验评价 (This product is evaluated through animal test)” shall be added before its health function claims on the label and package insert.
II. Manufacturers of the approved health food shall modify the labels and package inserts according to above requirements when reprinting them. By the end of 2020, all of the health food labels and package inserts shall be revised according to the requirements of this Notice.
III. From 1 January 2021, if the labels and package inserts are not revised according to above requirements, relevant enterprises will be punished according to relevant regulations in Food Safety Law of China.
IV. For the health food evaluated by human feeding trials, the specific evaluation technical requirements and labelling requirements will be separately prescribed.
2. Highlights! The interpretation of the Notice
I. For the health food that only evaluated by animal function test, the relevant health function and the modification requirements of function claims are as follows:
The modification requirements of function claims
“[Health function] This product is evaluated by animal test and has the function of enhancing immune.”
Increasing bone density
Alleviating physical fatigue
Enhancing anoxia endurance
Assisting irradiation hazard protection
Assisting the protection against chemical injury of liver
II. For the health food that evaluated by human feeding trials, before the specific evaluation technical requirements and labelling requirements issued, the health function claims remain unchanged.
III. If the health food contains multiple health functions, the labelling function claims shall be revised according to above requirements respectively.
For example: One health food has three health functions including enhancing immune, improving skin water content, and improving child growth.
- For “enhancing immune”, it is only evaluated by animal test;
- For “improving skin water content”, it is only evaluated by human feeding trials;
- For “improving child growth”, it
is evaluated by animal test and human feeding trials.
The function claim of this health food should be:
“[Health function] Enhancing immune, improving skin water content, and improving child growth (This product is evaluated by animal test and has the function of enhancing immune).”
IV. The health function claims of nutrition supplements (supplying vitamins and minerals) remain unchanged.
V. Applicants could revise the labels and package inserts according to the Notice without any change application with CFDA.
VI. “1 January 2021” mentioned in the Notice is the deadline of selling health food whose labels and package inserts have not been modified according to the Notice.
3. CIRS Comments
I. The labels and package inserts of health food that are going to register with CFDA shall be designed according to the new requirements of the Notice.
II. Manufacturers of approved health food：
- “1 January 2021” is the deadline for products sales. Therefore, if the health food contains the 7 functions that only evaluated by animal function tests (as mentioned in above table), relevant manufacturers could complete the modification of labels and package inserts in time according to their products sales cycle, to ensure that the products sold from the year of 2021 have complied with the requirements of the Notice.
- If the health food does not have the 7 health
functions, their labels and package inserts could remain unchanged for the
moment. However, enterprises are recommended to pay attention to the health
food regulations updates in China, so that can timely respond to the change of relevant
policies in the future.
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Reference:The Interpretation of SAMR about the Relevant Matters of the Notice.