Early life nutrition: DSM-firmenich gains new HMO approvals in Asia

dsm-firmenich, innovators in nutrition, health, and beauty, has announced the successful expansion of its human milk oligosaccharide (HMO) portfolio in China, Malaysia, and Thailand. Its 3’-sialyllactose (3’-SL) sodium salt ingredient has been approved for use in early life nutrition in the markets, alongside the authorization of 2’-fucosyllactose/difucosyllactose (2FL/DFL), lacto-N-tetraose (LNT), and 6’-sialyllactose (6’-SL) sodium salt in Malaysia and Thailand. Among the first companies to secure access for these HMOs in these countries, dsm-firmenich continues to lead the expansion of HMO solutions across key growth markets.

The Chinese National Health Commission (NHC) approved the use of 3’-SL—commercially known as GLYCARE® 3SL 9001—as a nutrition fortifier for inclusion in infant formula, formula for older infants and young children, formulated milk powders for children, and foods for special medical purposes for infants. The decision followed comprehensive technical reviews by the Ministry of Agriculture and Rural Affairs (MARA) and the China National Center for Food Safety Risk Assessment (CFSA). In Malaysia, the Ministry of Health (MOH) also approved 3’-SL sodium salt, as well as 2FL/DFL (GLYCARE® 2FL/DFL 8001), LNT (GLYCARE® LNT 8001), and 6’-SL sodium salt (GLYCARE® 6SL 9001) as optional ingredients in infant formula, follow-on formula, and formulated milk powder for children. The same four HMO products were also approved by the Thailand Food and Drug Administration for use in infant formula, follow-up formula for infants and young children, powdered milk substitutes, and milk-based beverages.

Emerging evidence suggests that combining HMOs with varied structures may help align the gut microbiota of non-breastfed infants with that of breastfed infants, while supporting broader health benefits. (Source: DSM-firmenich)

Together, these milestone achievements build on dsm-firmenich’s previous approvals for 2’-fucosyllactose (2’-FL) and lacto-N-neotetraose (LNnT) in China and Malaysia. This means that HMOs from all three major structural classes—fucosylated, sialylated, and neutral core—are nowEmerging evidence suggests that combining HMOs with varied structures may help align the gut microbiota of non-breastfed infants with that of breastfed infants, while supporting broader health benefits. available in these markets and can be used in combination with other approved HMOs, offering manufacturers enhanced flexibility to create differentiated HMO blends tailored to local nutritional needs. Emerging scientific evidence indicates that combining HMOs with different structures may help bring the gut microbiota composition of non-breastfed infants closer to that of breastfed infants and support a broader range of health benefits.^[1],[2],[3]

“These recent regulatory approvals in Asia reflect our continued commitment to expanding global access to high-quality, science-backed HMOs,” remarks Annette Lau, Global Regulatory Affairs Senior Manager ELN & MN at dsm-firmenich. “With a growing footprint across the Asia-Pacific region—including recent milestones in India, Indonesia, Australia and New Zealand—we are broadening the availability of different types of HMOs in key markets. By doing so, we’re enabling manufacturers to develop more advanced early life nutrition solutions that more closely align with the composition of human breast milk—the gold standard for infant nutrition—and support gut health, immune development, and overall wellbeing from infancy to early childhood.”