China Drafts New Rules on Probiotic Health Food, Paving Way for Product Filing
Jul 27, 2026
Jerry Wang
China’s SAMR draft introduces a dual-track registration-and-filing framework for probiotic health foods, replacing the long-standing registration-only approach for products that meet directory requirements.
The draft also tightens probiotic ingredient governance by requiring strain-level management, stricter raw material standards, and enhanced dossier and safety evidence for registration or filing.
On July 24, 2026, the State Administration for Market Regulation (SAMR) of China released the draft regulation Provisions on the Registration and Filing of Health Food Using Probiotics Raw Materials (Draft for Comments) (hereafter referred to as the Provisions) along with its drafting explanation to publicly solicit feedback. This significant overhaul proposes to establish a dual-track "registration and filing" system for probiotic health foods, marking a potential shift from the registration-only pathway that has been in place for nearly two decades. The deadline for submitting feedback is August 24, 2026.
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