CHINA – DSM-Firmenich, a leading innovator in health and nutrition, is celebrating a significant milestone as two of its human milk oligosaccharide (HMO) ingredients have received regulatory clearance for use as infant nutrition fortifiers in China.

This development opened up exciting opportunities for innovation in the field of early-life nutrition, ensuring that the unique benefits of HMOs are accessible to infants and young children in China.

The two HMO ingredients that have received approval in China are GlyCare™ 2’-fucosyllactose (2’-FL), the most prevalent HMO in human breast milk, and GlyCare™ lacto-N-neotetraose (LNnT), a complex sugar found in human milk that plays a vital role in the early development of an infant’s gut flora.

2’-FL has been approved for use in four food categories, including infant formula, formula for elder infants and young children, infant formula for special medical purposes, and formulated milk powder, with recommended usage levels between 0.7-2.4 g/L.

LNnT is available for the same applications at recommended levels of 0.2-0.6 g/L.

The China National Center for Food Safety Risk Assessment (CFSA) considered global data on HMO concentrations in human breast milk to establish the approved maximum usage levels. Currently, 2’-FL and LNnT are the only HMO ingredients approved in the Chinese market.

“We are extremely pleased to be able to announce this huge milestone for the China infant formula market and DSM-Firmenich,” James Young, Vice-President of Early Life Nutrition at DSM-Firmenich, stated.

“This approval reaffirms DSM-Firmenich’s leading position in the global HMO market. HMOs are the next important ingredient for bringing the composition of infant formula closer to breast milk, the gold standard of infant nutrition, and this approval ensures that all infants in China now have access to this important nutrient.”

Christoph Röhrig, Head of HNC Glycans & HMO Regulatory Affairs at DSM-Firmenich, highlighted the rigorous regulatory process that was followed to meet safety and health requirements.

He mentioned that the process included safety clearance from the Chinese Ministry of Agriculture and Rural Affairs (MARA) for several HMO production strains, followed by a comprehensive food additive approval process by CFSA, which involved a technical assessment and consideration of public comments.

“Human milk oligosaccharides (HMOs) are gaining increased attention in the health and nutrition sector due to technological advancements and growing scientific evidence supporting their potential benefits for infant health, including immune function, gut health, and cognitive development.”

DSM-Firmenich is a leader in HMO research, development, and production and is continuously pushing the boundaries in this field while expanding its offering in the early-life nutrition and dietary supplement markets.

Meanwhile, the company’s science-backed GlyCare HMO portfolio is already available for use in over 160 countries worldwide.