DSM-Firmenich’s 3-FL human milk oligosaccharide ingredient approved as novel food in EU

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DSM-Firmenich (Kaiseraugst, Switzerland; Heerlen, Netherlands) announced that its 3-fucosyllactose (3-FL) human milk oligosaccharide (HMO) ingredient is now approved as a novel food ingredient in the European Union. Glycom A/S, which is controlled by DSM-Firmenich AG, submitted the novel food application for the ingredient, which is called GlyCare 3FL 9OO1. The European Commission approved the application.

The company says that the GlyCare 3FL 9OO1 ingredient is now approved in the EU at a higher usage level compared to other 3-FL ingredients. A press release states: “Notably, DSM-Firmenich’s 3-FL ingredient has been granted a higher maximum use level of 1.75 g/L for use in infant and follow-on formula, compared to levels approved previously for other 3-FL manufacturers, which ranged from 0.85-1.20 g/L.” DSM-Firmenich will maintain exclusive approval for the 1.75 g/L dose for five years.

“Only after the exclusivity period ends, the highest approved use level will apply across all different sources of approved 3-FL,” the press release states. “The authorization of the higher use level was made possible thanks to DSM-Firmenich’s recent review on the mean concentration of HMOs in global pooled human milk, which included updated summary statistics for 3-FL.”

Key markets for 3-FL include early life nutrition, conventional foods, medical foods, and dietary supplements. 3-FL is produced from a derivative strain of Escherichia coli K-12 DH1. “3-FL is one of the most abundant fucosylated HMOs in human milk, and scientific studies have demonstrated its promising potential to support immunity, gut health, and potentially cognitive development,” added Christoph Röhrig, head of global HMO regulatory affairs, DSM-Firmenich, in the press release.

Marta Miks, senior regulatory and scientific affairs manager, DSM-Firmenich, added, “The recent regulatory approval of 3-FL as a novel food in the EU means the ingredient joins our existing authorized portfolio of six HMOs in the region, including 2’-fucosyllactose (2’-FL), lacto-N-neotetraose (LNnT), difucosyllactose (DFL), lacto-N-tetraose (LNT), 3’-siallactose (3’-SO) sodium salt, and 6’-sialyllactose (6’-SL) sodium salt. 3-FL stands out among other fucosylated HMOs as a distinctive component found in all maternal milks worldwide because unlike most HMOs, 3-FL levels exhibit a gradual increase throughout the course of lactation.”