On February 5, 2026, China’s NHC issued the No.1 Announcement of 2026. 3’-SL was approved as a new food nutrition enhancer, becoming the third officially authorized human milk oligosaccharide (HMOs) following 2’-FL and LNnT.
Among them, 3’-SL derived from Escherichia coli W (ATCC 9637) is a product of Meihua Group, with the entire regulatory submission handled by CIRS Group. CIRS worked closely with the company throughout the process, efficiently advancing the submission and supplementation of materials, and actively coordinating with the working group and official authorities, ultimately securing the product approval successfully.
3’-SL, recognized internationally as a key nutrient, offers a variety of functional benefits. Naturally abundant in human breast milk, 3’-SL is a core component of acidic sialylated HMOs, and its nutritional necessity is widely acknowledged globally. Multiple clinical and in vitro/in vivo studies have shown that 3’-SL promotes gut microbiota health, regulates immunity, supports infant brain development and cognitive function, and enhances language abilities. Its recent approval marks another significant milestone for compliant HMO ingredients in China, facilitating formula upgrades and helping break product homogeneity. Leveraging its professional service capabilities and experience in synthetic biology-related submissions, CIRS Group has successfully supported multiple domestic and international HMO approval cases, and is actively assisting companies in advancing compliance for other HMOs in China, such as 6’-SL, 3-FL, and LNT.
About Meihua Group
Meihua is a global leader in large-scale bio-manufacturing and a trusted supplier of nutritional products, specializing in amino acids. After more than 20 years of development, Meihua has become a global leading provider of amino acid nutrition solutions, with an amino acid production capacity exceeding 4 million tons.
Meihua offers over 50 products, widely applied in food processing, animal feed, pharmaceutical and health industries, personal care and moisturization, petroleum extraction, and agriculture. On July 1, 2025, the company announced the successful completion of its cross-border acquisition of the amino acid and HMO business from Japan’s Kyowa Hakko. This marks another milestone for Chinese biomanufacturing enterprises in the global amino acid industry chain.
About CIRS Group
Headquartered in Hangzhou, CIRS operates 11 subsidiaries across the United States, Europe, South Korea, and Japan. With a specialized global novel ingredient registration team, it provides comprehensive global submission services for novel food ingredients in China, GRAS notice in the U.S., Novel Food approvals in the EU, and novel feed additives in China, Europe, and the U.S. It boasts extensive experience and numerous successful cases, including D-allulose, HMOs, steviol glycosides, NMN, Glucosamine Hydrochloride, NAG, and other substances produced using synthetic biology technologies, as well as various alternative proteins, PQQ, Wheat Polar Lipids, Jatropha Curcas, AKK, Probiotics, and more.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
