China’s National Center for Food Safety Risk Assessment (CFSA) approved the use of two specific human milk oligosaccharides (HMOs) to fortify infant nutrition products.

The only two HMOs which received this approval were 2’-fucosyllactose (2’-FL), the most prevalent HMO in human breast milk, and lacto-N-neotetraose (LNnT), which is considered biologically relevant in the early development of the infant gut flora.
 
CFSA took into account data on the concentrations of HMOs found in human breast milk to set approved maximum usage levels of the two HMOs that were approved. Currently, 2’-FL and LNnT are approved for maximum usage levels set at 0.7-2.4 g/L and 0.2-0.6 g/L, respectively.
 
International ingredient suppliers IFF and dsm-firmenich were among the first companies to have their HMO ingredients achieve regulatory clearance for use in this category.
 
HMOs have been garnering attention in the nutrition space due to a growing bank of scientific evidence supporting their roles in infants’ immune function, gut health, and, potentially, cognitive development. They’ve been available in the U.S. and European markets for several years.
 
A Huge Opening for the Infant Nutrition Market
 
dsm-firmenich reported that its 2’-FL ingredient and LNnT ingredients have been approved for use in infant formula, follow-up formula, infant formula for special medical purposes, and formulated milk powder.
 
Meanwhile, IFF’s 2’-FL ingredient was approved for infant formula, follow-up formula, and formula for special medical purposes.
 
China’s milk formula market accounts for close to 50% of the total retail value of the global milk formula segment. Prior to the approvals of 2’-FL and LNnT, no HMO molecules were permitted for use in infant formula in China.
 
“We are extremely pleased to be able to announce this huge milestone for the China infant formula market and dsm-firmenich,” said James Young, vice president of early life nutrition at dsm-firmenich. “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.”
 
“The infant formula industry has eagerly awaited the approval of 2’-FL in China, since it will allow producers to formulate a new generation of products for the early-life nutrition segment,” said Marcus Gliwitzki, global product manager, health, IFF. “Today’s decision will help us better serve customers in all major markets and respond to the rising global demand for infant nutrition products.”