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To help companies better understand the design requirements for the labeling of prepackaged special dietary foods, CIRS Group has compiled a summary of the key changes in this draft for reference, based on the draft and its compilation notes.

Human milk oligosaccharides (HMOs) are the third most abundant solid nutrient in breast milk, following only lactose and lipids. HMOs form a variety of complex structures through different combinations of five basic components—glucose, galactose, N-acetylglucosamine, L-fucose, and N-acetylneuraminic acid—and possess multiple functions, including regulating the gut microbiota, establishing the intestinal barrier, boosting immunity, and enhancing cognitive development.

As of March 31, 2026, a total of 20 Foods for Special Medical Purposes (FSMPs) were approved in the first quarter of 2026, bringing the cumulative number of approved FSMPs in China to 310.

CIRS Group has compiled and summarized the intended uses and use levels of HMOs approved in the EU for industry reference. Among them, chemically synthesized and microbially produced 2’-FL have identical scope of use and use levels; similarly, chemically synthesized and microbially produced LNnT share the same conditions of use. The remaining HMOs are produced via microbial sources, and their intended uses may vary depending on the production organism.

There are more than 200 types of HMOs, each with specific structures and functions, enabling applications across different fields. As a result, regulatory submissions for HMOs are rapidly increasing worldwide, with commercialization first initiated in Europe and the United States. In 2015, the U.S. Food and Drug Administration (FDA) recognized the first HMO—chemically synthesized 2’-fucosyllactose (2’-FL) submitted by Glycom A/S—as Generally Recognized as Safe (GRAS). Since then, multiple HMOs have successively obtained GRAS status in the United States.

This article summarizes the approval status and usage of HMOs in the Australia–New Zealand for industry reference.

On March 18, the State Administration for Market Regulation (SAMR) released the Q&A on the Registration of Foods for Special Medical Purposes under the New National Standards. The document aims to guide enterprises in conducting compliant applications and efficient registration in accordance with two national food safety standards: General Principles for Foods for Special Medical Purposes (GB 29922—2025) and Foods for Special Medical Purposes for Tumor Complete Nutrition (GB 31662—2025), thereby ensuring a smooth and orderly market supply transition.

Recently, China’s Food Evaluation Center of the State Administration for Market Regulation released answers to frequently asked questions about infant formula product formulation.

As of December 31, 2025, a total of 59 Foods for Special Medical Purposes (FSMPs) were approved in 2025 (registration number: 国食注字TY2025XXXX), bringing the cumulative number of approved FSMPs in China to 290.

In our previous articles, we have translated the frequently asked questions regarding the health food acceptance and the application of infant formula products in China. Today, we will continue with the FAQs on the application of food for special medical purposes in China.