Dsm-firmenich announces UK and EU approval for 3-FL and LNFP-I/2'-FL human milk oligosaccharide ingredients

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Dsm-firmenich (Kaiseraugst, Switzerland and Heerlen, Netherlands) has announced that its human milk oligosaccharide (HMO) ingredients – 3-fucosyllactose (3-FL) and lacto-N-fucopentaose I/2'-fucosyllactose (LNFP-I/2'-FL) mixture – have been approved as a novel food ingredients by the United Kingdom and European Union. According to the company, dsm-firmenich is the first and only supplier to receive approval for LNFP-I.

The UK approval is effective June 28, 2024 and covers both 3-FL and the LNFP-I/2'-FL mixture while the EU approval, effective July 2024, relates only to the LNFP-I/2'-FL mixture. The approvals allow for the HMOs to be used a range of food categories, including infant formula, follow-on formula, conventional foods, food for special medical purposes and food supplements. The company’s announcement states that the UK approval is unique in that it also permits the use of the HMOs in supplements for infants and young children, opening up new possibilities for product development in early life nutrition.

Additionally, the EU approval introduces two significant changes. The first change removes age restrictions for young children for milk-based drinks and similar products, and the second introduces separate age categories for food for special medical purposes which will have distinct maximum levels for infants/young children and other age groups.

"These authorizations reflect a growing understanding of HMOs' potential benefits in early life and beyond infancy, creating unprecedented opportunities for tailored nutrition solutions," said Christoph Röhrig, PhD, head of the global HMO regulatory affairs team at dsm-firmenich, in a press release. "From infant formula to adult supplements, we're now poised to explore various HMO blend solutions and applications that support nutrition and health throughout the lifespan."

“The approval of LNFP-I/2'-FL marks a significant milestone as the first authorization for a pentasaccharide HMO in both the UK and EU,” added Marta Miks, DSc, PhD, dsm-firmenich’s senior regulatory and scientific affairs manager. “This expands our portfolio beyond tri- and tetrasaccharide HMOs, showcasing our commitment to innovation in early life nutrition. Notably, LNFP-I is among the most abundant HMOs in breast milk. Its approval, along with that of 3-FL in the UK, allows us to develop products that more closely reflect the complex composition of human milk to support healthier infant development. As we continue to uncover the potential benefits of HMOs, these approvals pave the way for new research and product innovation opportunities beyond early life nutrition alone."