DSM-Firmenich working to fortify infant formula in China through HMO regulatory approval

13 Jul 2023 --- As one of the largest producers of human milk oligosaccharides (HMOs) in the world, DSM-Firmenich is confirming expansion plans into the stringent Chinese infant formula market. The company has submitted its GlyCare 3’-sialyllactose (3’-SL) and 6’-sialyllactose (6’-SL) ingredients to China’s National Health Committee and the China National Center for Food Safety Risk Assessment.

The ingredients join the company’s other submissions – lacto-N-neotetraose (LNnT) and 2’-fucosyllactose (2’-FL) – through regulatory Nutrition Fortifier (NF) dossiers. HMOs are highly potent ingredients and essential elements found in breast milk.

They have been shown to play significant roles in promoting infant nutrition and well-being by contributing to the health of the gut, enhancing immune function and potentially aiding cognitive development.

“The authorization process in China is stringent and highly challenging to navigate, comprising multiple rounds of technical review by scientific and regulatory experts, as well as a rigorous approval process that safeguards the safety and benefit of nutrition fortifiers intended for infants and young children,” says Annette Lau, the global regulatory affairs manager, ELN at DSM-Firmenich. 

“We continue to take positive strides in the region – first with the favorable progression of our 2’-FL and LNnT nutrition fortifier regulatory submissions, and now the submission of 3’-SL and 6’-SL.”HMOs are an important part of human breast milk with many proven health benefits.

Years in the making
According to the company, its 6’-SL and 3’-SL HMO strains already received safety clearance from the Chinese Ministry of Agriculture and Rural Affairs in the last quarter of 2021. The two ingredients are now in the final stage of the assessment process.

Now, these next two submitted dossiers will undergo the same rigorous regulatory process to be registered as an early life nutrition additive.

“Successfully breaking into complex markets, like China, highlights our teams’ unmatched multidisciplinary teamwork, cross-regional approach, regulatory expertise and their unbreakable commitment to advancing the HMO space,” Lau emphasizes. 

“This latest progress is set to create significant innovation opportunities in the early life nutrition landscape – and, ultimately, make the unique benefits of HMOs accessible to more infants and young children globally.”

With ongoing HMO research and development, the company says it is looking to constantly advance the field and broaden its range of offerings in early life nutrition and dietary supplements across the globe. Currently, DSM-Firmenich’s GlyCare HMO portfolio is available in over 160 countries to support optimal infant development and nutrition.

Edited by William Bradford Nichols