On April 17, 2018, the interpretation on announcement of CFDA about “regulation on standardizing the identification of health food functional claims” (No. 23 of 2018) was issued by State Administration for Market Regulation (SAMR):
On February 13, 2018, the former CFDA issued the “Regulation on Standardizing the Identity of Health Food Functional Claims” (No. 23 of 2018), which clarified the relevant matters concerning the declaration of the function of health foods. Firstly, health foods that have not been evaluated for human consumption have the words “animal tests evaluated by the product” added before the health function claims in the label instructions; secondly, health food production enterprises that have been approved for listing should be reprinted when labeling instructions, modify the label instructions as described above. By the end of 2020, all health food label instructions must be revised in accordance with this requirement. Third, since January 1, 2021, if the label specification has not been modified according to the above requirements, it shall be investigated and handled in accordance with the relevant provisions of the "Food Safety Law." In order to further clarify the health food claim specification, the announcement is explained as follows:
For health foods (other than nutrient supplement products) that have not been evaluated for human consumption, the words “this product has been evaluated by animal experiments” should be added before the health function claim under the label “Health Care Function”. Marked as "[health care function] This product has been evaluated by animal experiments and has xxx health functions."
Before the new evaluation technical requirements and labeling regulations are released, the original health care function claims will remain unchanged for those health foods that have been approved for circulating on the market and health care functions are subject to human consumption evaluation.
Health foods that involve claims for a number of health functions should be marked separately according to the above requirements based on the evaluation of animal experiments and the assessment of human consumption. For example, the health function "A" is evaluated only by animal experiments; the health function "B" is evaluated only by the human consumption; the health function "C" is assessed by animal experiments and human consumption. Marked as "[health care function] A, B, C (assessed by animal experiments, with A health function)."
The nutrition supplement product does not involve animal experiments and human consumption evaluation. The health care function claims that the label is unchanged and is labeled as “[Health Function] Supplement ×××”.
The applicant should modify the label and description according to the requirements of the announcement, and there is no need to submit a change application for the content.
The term "since January 1, 2021" mentioned in Article 3 of the Announcement refers to the deadline for the sale of health foods that has not been modified in accordance with the above requirements.
