SAMR Consults on Rules for Application and Review of Probiotic Health Food

On March 20, 2019, State Administration for Market Regulation (SAMR) opened Rules for Application and Review of Probiotic Health Foods (consultation draft) to public consultation^[1]. The draft details definition, necessary dossiers, requirements for probiotics, minimal level of active probiotics etc. Deadline for comments is April 20.

At present, the regulation that governs the application and review of this type is Rules for Application and Review of Probiotic Health Foods (trail)^[2]. The trail draft has been in effect since July 1, 2005 and some of its content is outdated. Compared with current version, major changes^[3] of the draft rules are:

More accurate definition

Probiotic health food refers to microbial products whose main active ingredients are probiotics and contains necessary auxiliary materials. The use of probiotics are associated with improvements in specific physiological pathways.

Probiotic health food excludes inactive probiotics and their metabolites

The draft no longer recognizes health foods whose main ingredients are inactive probiotics or corresponding metabolites. Naming of health foods made from killed probiotics or their metabolites shall comply with article 56 of Administrative Measures on Registration and Filing of Health Foods^[4]. Its general name should be named after its active ingredient.

Explicit approval of food bacterial cultures in health foods

The first list of probiotics permitted in health food was launched in 2001 and has not been updated since. However, bacterial cultures that are approved for use in ordinary foods have also been allowed to be used in health foods. This draft has clarified the scope of permitted probiotics in health foods.