SAMR Issues Provisions for Declaration and Review of Probiotic Health Food (Draft) for Public Comments

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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:

S.N.

Changes

Key Points

Notes

1

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 microorganisms.

2

Definition 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 food.

3

Some 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.

4

Some information is deleted

Delete “The list of probiotics for health food is issued by the State Food and Drug Administration.”.

The bacteria (strains) for food issued by the competent authorities can be used for probiotic health food.

Delete “It 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 attribute name.”).

If you have any needs or questions, please contact us at service@cirs-reach.com.

Reference:

SAMR Official News