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Infant Formula & FSMP
On October 10, 2026, the State Administration for Market Regulation publicly solicited comments on the “Draft Amendment to the Food Safety Law of the People’s Republic of China (Draft for Public Comment),” explicitly proposing to formally classify infant and young children complementary foods as special foods under regulatory oversight and implement strict filing requirements. This amendment addresses regulatory gaps in the oversight of infant and young children complementary foods, establishing a comprehensive safety management system covering all categories of infant and young children foods.
On September 20, 2026, the State Administration for Market Regulation (SAMR) released the FAQs on Labeling Requirements for Infant and Young Children Formula Foods (the “FAQs”), providing further clarification on labeling requirements for infant and young children formula milk powder and liquid formula. The FAQs address several key labeling issues, including the indication of production dates and shelf-life expiration dates, allergen statements, milk-source and organic certification claims, label changes and filing requirements, production by other companies within the same corporate group, and the transition between old and new labels.
The European Commission issued Regulations (EU) 2026/1825 and 2026/1890, amending Regulation (EU) 2023/915 to establish or tighten maximum contaminant levels for 3-MCPD, glycidyl fatty acid esters, furan, and methylfurans in foods, particularly infant formulas, edible oils, and composite foods. Phased implementation deadlines span August 2026, January 2027, and January 2028.
The State Administration for Market Regulation has revised and drafted the Detailed Rules for the Review of Production Licensing for Infant and Young Child Complementary Foods (Draft for Comment) and is now soliciting public opinion. The deadline for submitting comments is August 1, 2026.
Since 2020, Taiwan Food and Drug Administration has gradually released usage restrictions and labeling regulations for six new food raw materials produced from genetically modified microorganisms, including three 2′-fucosyllactose, astaxanthin, Ganoderma microsporum globulin-like protein concentrate, and trans-resveratrol. CIRS Group has compiled key information on these 6 products for industry reference.
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.