,"China’s State Administration for Market Regulation (SAMR) has unveiled draft companion documents governing the registration and stability requirements for infant liquid formula (婴幼儿配方液态乳), following the recent revision of the Food Safety Law which formally brings liquid infant formula under the same registration regime as powdered formula.
Under the proposed revisions to the “Infant Formula Milk Powder Product Formula Registration Management Measures,” the agency clarifies that the same regulatory framework will now apply to liquid infant formula products. Because liquid formulas present higher risks for microbiological contamination and stability issues versus powder, the draft sets stricter requirements in three major areas:
Microbial Risk Control of Raw and Auxiliary Materials — Specifically, the draft demands control over psychrophilic bacteria (cold-loving bacteria) and heat-resistant spores in raw milk and additive materials to ensure safety from both storage and processing stages.
Stability in Product Development — Manufacturers are to establish internal control evaluation standards, define stability metrics and indicators, and devise test methods to ensure that liquid formula remains stable over shelf life.
Verification of Processing, Product Testing, and Sterilization — The draft requires validation of the production process, rigorous product inspection, and demonstration of effective sterilization (or other microbial kill step), so that the final product meets safety standards.
Moreover, SAMR has released a Draft Guideline for Shelf-Life Stability Research of Liquid Infant Formula (征求意见稿) to guide enterprises in how to conduct stability studies — defining principles, required test samples and projects, trial methods, report contents, and key stability test items.
No specific numerical limits (e.g. for microbial counts, spore loads, or shelf-life duration) are provided in the public drafts shared so far; rather, the focus is on procedural and methodological rigor. The documents are now open for public comment, with SAMR inviting feedback from stakeholders to finalize the rules."
Consumer News Region