Interpretation of Issues Concerning the Announcement of Regulating the Declaration of the Function Claim of Health Food

On April 19th, February 19th, 2018, the Pharmaceutical and Drug Administration of the People's Republic of China issued the “Announcement on Regulating the Label of Functional Claim of Health Food” (No. 23 of 2018), which clarified the relevant matters concerning the identification of health food function claims. Firstly, health food products that have not been evaluated for human consumption have the words “animal experiments evaluated” before the health function claims in the label instructions. Second, the health food production enterprises that have been approved for listing should be reprinted. When labeling instructions, modify the label instructions according to the above requirements. Before the end of 2020, all health food label instructions need to be modified in accordance with this requirement; Third, since January 1, 2021, if the label specification was not modified according to the above requirements, press The relevant provisions of the "People's Republic of China Food Safety Law" investigate and punish. In order to further clarify the health food functional claims logo specification, the following is an interpretation of the announcement:

I. Evaluation without human consumption health care For foods (other than nutrient supplement products), the word “Evaluation of Animals through Animal Experiments” should be added before the health function claim under the label, manual “Health Care Function”. This item is labeled “Health Care Function” and evaluated by animal experiments. With × × × health function'.

2. For health foods that have been approved for listing, their health care functions have been assessed by the population. Before the new evaluation technical requirements and labeling regulations are issued, the original health care function claims will remain unchanged.

For health foods that involve multiple claims for health functions, they should be labeled separately according to the above requirements according to the evaluation of animal experiments and the assessment of human consumption. For example, the health function 'A', evaluated only by animal experiments; health function 'B', only Crowd consumption evaluation; Health function 'C', evaluated by animal experiments and human consumption. Marked as 'health care function' A, B, C (assessed by animal experiments, with A's health care function) '.

Third, nutrient supplement products do not involve animal experiments and human consumption evaluation. The health care function claims that the identity does not change and is labeled as ''health care function supplement''×××'.

4. The applicant shall modify the label and the specification as required by the announcement, and it is not necessary to make a separate change application for this item.

5. The term 'from January 1, 2021' mentioned in the third article of the announcement refers to the failure to modify the label's specification as described above. Healthy food Sales deadline.