China Issues New Management Method of Health Food Registration Alteration

On November 26, 2020, China State Administration for Market Regulation (“SAMR”) published a notification on management of health food registration alteration applications.

According to this notification, alteration applications will be managed based on the regulations referred when applying for the original health food registration. Such alteration should not affect health food product quality and safety, or invalidate the registration.

The contents of registration alterations subject to this notification include:

• Remove health function;

• Change product name;

• Modify contents on labels and instructions (limited to deleting the preface, removing health functions, reducing the scope of the “suitable for” or expand the scope of “unsuitable for”, standardizing the expression of specifications or cautions, and specifying edible method).

There are two conditions for the alteration application:

1. If the original registration was approved on the basis of the Administrative Measures for Registration and Filing of Health Foods, new health food registration certificate would be issued directly after reviewing. This condition does not involve function changes.

2. If the original registration was approved on the basis of rules and regulations before the implementation of the Administration Measures, a result notice would be issued by the competent authority after reviewing the application. The result can be either approval or rejection. The result notice should be used together with the original registration certificate.

Influence on Health Food

This notification mainly affects health food products registered on the basis of rules and regulations before the implementation of the Administration Measures, which were probably registered with currently prohibited functions. Such products have to remove the prohibited functions according to current regulation, and those registered with only one prohibited function will be cancelled. Moreover, as China consulted on deleting three function claims (promoting lactation, improving growth and improving skin lipid) for health food registration on Nov. 24, 2020, a possible tendency is that health food registered with these three functions will probably have to remove the functions after the consultation draft is officially published and implemented.