China's draft rules for probiotic supplements ask for a strain number and a live count
- Source and genre. On 24 July 2026 China's State Administration for Market Regulation (SAMR) opened a public consultation, running to 24 August, on a draft titled "Provisions on Applications for Registration and Notification of Health Foods Using Probiotic Raw Materials". It is a draft for comment, not a rule in force. It revises the existing trial provisions on probiotic health foods.
- The draft requires that the strain be within the list of strains usable in food published by the National Health Commission, be identified down to the strain number, and have clear and stable biological, genetic and functional properties. Commercial probiotic raw material must be a single strain, and all excipients must be listed on the label and instructions.
- Applicants for registration must submit safety data: genetic stability, an antibiotic resistance test report and a toxin production test report. The registered product must contain a total live bacteria count of not less than 10^7 CFU/mL(g) throughout its shelf life.
- A route is created for proposing a strain or raw material for the health food raw material catalogue, on the basis of a full evaluation of the strain and the commercial raw material. The announcement does not mention mental health, mood or anxiety.
China's market regulator has published a draft for public comment that would tighten how probiotic supplements are registered or notified as health foods. It concerns manufacturers and importers selling in China, and it matters to clinicians elsewhere as an example of what a regulator asks a probiotic product to prove.
What the draft asks of the strain
The announcement lists five changes. The strain must appear on a National Health Commission list and be named to the strain number, with biological, genetic and functional properties stated as clear and stable. The commercial raw material must be one strain only. Registration files must carry genetic stability data, an antibiotic resistance report and a toxin production report.
Viability and the catalogue route
The draft sets a floor of 10^7 CFU/mL(g) for total live bacteria across the shelf life. It also opens a channel for any organisation or individual to propose a strain and its commercial raw material for the catalogue of health food raw materials. SAMR describes the aim as a system covering strain traceability, raw material control, production control and live bacteria testing.
A strain number at the bedside
Nothing in the announcement ties any strain to a psychiatric indication. What it standardises is identity, safety documentation and viability. That is useful to a clinician in a narrow way, and the next paragraph is the author's opinion, not SAMR's position. When a client says a probiotic helped their mood, "probiotic" is not yet a claim worth discussing. The useful questions are which genus, species and strain number, whether a trial of that exact strain exists in the condition in question, and whether the product holds the live count at the end of its shelf life. A trial result belongs to the strain that was tested, and a label that names only a species leaves that unanswered.
The draft requires a strain number and a live count for every probiotic health food. It says nothing about mood.
This is a draft for public consultation, summarised from SAMR's published announcement, and the final text may differ. It concerns the registration and notification of health foods in China and applies to no other jurisdiction. It makes no statement about mental health, and no clinical efficacy is claimed here for any strain.