SAMR Issues Provisions for Declaration and Review of Probiotic Health Food (Draft) for Public Comments
from CIRSby Jolin
On March 20, 2019, the State Administration for
Market Regulation (SAMR) issued the Provisions
for Declaration and Review of Probiotic Health Food (Draft for public comments) (hereinafter referred to as “the Draft”), comments can be submitted before
April 20, 2019.
Currently, the declaration and review of probiotic
health food is based on the Provision for
Declaration and Review of Probiotic Health Food (Trial) which was implemented
on July 1st, 2005 (hereinafter referred to as “the Trial”). In order
to help enterprises obtain the key information, CIRS made a comparative
analysis between the Draft and the Trial. Differences have
been listed in below:
Definition of Probiotics become clearer
Probiotics refer to living microorganisms which are beneficial to human
health when ingested in sufficient quantities.
Probiotics are required to be living
of Probiotic Health Food is modified
Probiotic Health Food is a kind of microbial products which take
probiotics as the main functional ingredients and add necessary excipients. They
are beneficial to human health when ingested in sufficient quantities.
Health food produced with
dead bacteria and microbial metabolites do not belong to probiotic health
declaration dossiers required to be submitted are supplemented
Supplement “Provide the basis for the use of strains, raw material
inspection report etc.”
Supplement “The research report, scientific literatures,
etc. that related to probiotic functions should be based on specific strains”.
Research report, scientific literatures, etc.
related to probiotic functions are required to be based on specific strains.
information is deleted
list of probiotics for health food is issued by the State Food and Drug
The bacteria (strains)
for food issued by the competent authorities can be used for probiotic health
is not recommended to produce probiotics in liquid form.”
The Draft also mentions that “In
terms of health food produced with dead bacteria and microbial metabolites, their
general name shall be the functional components instead of the probiotics being
used. In addition, product name shall also comply with the 56th of Administrative Measure on Health Food
Registration and Filing”.
(PS: the 56th of
Administrative Measure on Health Food Registration and Filing refers to “The
name of health food shall be composed of trademark name, general name and
If you have any needs or questions, please contact us at firstname.lastname@example.org.