dsm-firmenich expands HMO portfolio with regulatory approvals in Asia

Ingredients supplier dsm-firmenich is expanding its human milk oligosaccharides (HMOs) portfolio in China, Malaysia, and Thailand, making it one of the first companies to provide secure access to HMOs in these countries. 

The company’s 3’-sialyllactose (3’-SL) sodium salt ingredient, commercially known as Glycare 3SL 9001, received regulatory approval in all three markets for use in early-life nutrition.

Malaysia, and Thailand, making it one of the first companies to provide secure access to HMOs in these countries.

The company’s 3’-sialyllactose (3’-SL) sodium salt ingredient, commercially known as Glycare 3SL 9001, received regulatory approval in all three markets for use in early-life nutrition. 

Meanwhile, its 2’-fucosyllactose/difucosyllactose (2FL/DFL), lacto-N-tetraose (LNT), and 6’-sialyllactose (6’-SL) sodium salt have gained regulatory approval in Thailand and Malaysia.

“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 for Early Life Nutrition and Medical Nutrition at dsm-firmenich.

She says with a growing footprint across the Asia-Pacific region, including recent milestones in India, Indonesia, Australia, and New Zealand, the company is 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 well-being from infancy to early childhood.”

The company’s recent 2025 financial report revealed net sales of €9.03 billion (US$10.7 billion) and regulatory approvals for its HMOs in over 170 countries.

Expanding with approvals

The Chinese National Health Commission approved the use of Glycare 3SL 9001 as a nutrition fortifier for infant formula, formula for older infants and young children, milk powders for children, and foods with special medical purposes for infants.

All three major structural classes of HMOs are now available in China and Malaysia.dsm-firmenich says approval has been granted following a comprehensive technical review by the China National Center for Food Safety Risk Assessment and the Ministry of Agriculture and Rural Affairs.

In Malaysia, the Ministry of Health approved 3’-SL sodium salt, 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 powders for children.

Thailand’s Food and Drug Administration approved the same four HMOs to use in infant formula, follow-up formula for infants and young children, powdered milk substitutes, and milk-based beverages, explains the company.

The approvals in China and Malaysia build on previous approvals for 2’-fucosyllactose (2’-FL) and lacto-N-neotetraose (LNnT), meaning that all three major structural classes of HMOs — fucosylated, sialylated, and neutral core — are now available in these markets.

Meanwhile, these can also be combined with other approved HMOs, providing manufacturers with greater flexibility to produce 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,” notes the company.

The company recently told Nutrition Insight that the global HMO market is rapidly evolving, with demand strongest among parents seeking premium infant formulas that closely align with the complexity of human milk. It said China and the broader Asia-Pacific region lead this growth, with Hong Kong and Vietnam at the forefront of innovation and dosage levels.