Industry Trends

In 2026 the State Administration for Market Regulation issued the *Regulations on Declaration and Filing of Health Food Using Probiotic Raw Materials (Draft for Comments)*. This was the first comprehensive revision since the trial version introduced in 21 years ago of 2005, marking the industry’s transition from primary development to precise regulation.

Core Revision Content

The revision strengthened regulatory from "species" to "strain" level, clarifying requirements for probiotic raw materials and end products. Enterprises had to meet two key compliance requirements:

*Procuring Raw Materials (Single-Strain Source): To procure single-strain probiotic raw materials and pre-mixed multi-strain not permitted. Strains submitted for registration was identified by strain number, with clear biological, genetic, and functional characteristics to ensure independent traceability and verification.

*Manufacturing End Products (Reconstitution Permitted): Allowed to reconstitute multiple single-strain raw materials into multi-strain end products. Each strain must independently compliant with corresponding safety assessments and justification for combination rationality.

Higher Safety Standard

The new registration required the safety assessment materials of strain genetic stability data, antimicrobial resistance and toxin production test reports. And the registered products must contain a total live probiotic count of no less than 107 CFU per daily consumption throughout the shelf life, which was ten times over the current standard of 106CFU.

Industry Impact

Associate Professor Zhu Yi of China Agricultural University noted new rules shifting regulation from category to individual control, setting "one strain, one number" system. This stopped data misappropriation and borrowed between strains to enable traceability of genetic stability, antimicrobial resistance and toxin production risks.

Notably, the new rules applied specifically to "Blue Hat" probiotic health food and not covering the yogurt and probiotic beverages.