DSM-Firmenich takes next steps toward regulatory approval in China for two more HMO ingredients for early-life nutrition

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DSM-Firmenich (Kaiseraugst, Switzerland) is taking next steps to obtain regulatory approval in China for two more of its human milk oligosaccharide (HMO) ingredients for use in early-life nutrition products. The company has submitted Nutrition Fortifier (NF) dossiers for its GlyCare 3’-sialyllactose (3’-SL) and 6’-sialyllactose (6’-SL) ingredients to the China National Center for Food Safety Risk Assessment (CFSA) and National Health Committee (NHC).

According to the company’s press release, “The HMO production strains of DSM-Firmenich’s 3’-SL and 6’-SL have already received safety clearance confirmed by the Chinese Ministry of Agriculture and Rural Affairs (MARA) in September 2021. In the next stage, both 3’-SL and 6’-SL NF dossiers will go through a rigorous multiphase regulatory assessment by CFSA to achieve food additive registration for early-life nutrition (ELN) use in China.”

Meanwhile, two of the DSM-Firmenich’s other HMO ingredients, 2’-fucosyllactose (2’-FL) and lacto-N-neotetraose (LNnT), are now in the final stages of being approved as a food additive in China following a 2021 dossier submission.

As critical components of human breast milk, HMOs play key roles in supporting gut health, immune function, and potentially cognitive development in infants.

“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,” said Annette Lau, global regulatory affairs manager, ELN, DSM-Firmenich, in a press release. “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.”