Dsm-firmenich, a global innovator in health, nutrition and beauty, today announced the successful approval of its human milk oligosaccharide (HMO): 3-fucosyllactose (3-FL) and lacto-N-fucopentaose I/2′-fucosyllactose (LNFP-I/2′-FL) mixture as novel food ingredients in the United Kingdom and European Union. These landmark authorizations further solidify the company’s position as a leader in early life nutrition innovation and expand potential applications for HMOs across various life stages. Notably, dsm-firmenich is the first and only supplier to receive approval for LNFP-I, marking a significant milestone in HMO innovation and availability.
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The UK approval, effective June 28, 2024, covers both 3-FL and the LNFP-I/2′-FL mixture. These are the first two HMO approvals assessed by the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in post-Brexit UK, representing a pivotal development in the country’s novel food regulatory landscape. Concurrently, the European Commission authorized the LNFP-I/2′-FL mixture in July 2024. These approvals will allow for the marketing of GlyCare™ 3FL 9001 and GlyCare™ LNFP-I/2FL 8001 across a wide range of food categories, including infant formula, follow-on formula, conventional foods, food for special medical purposes and food supplements.
The UK approval breaks new ground by permitting the use of these HMOs in supplements for infants and young children, opening up new possibilities for supporting early life nutrition from birth. The EU authorization also introduces two significant changes. First, it removes age restrictions to young children for milk-based drinks and similar products, expanding potential applications to all age groups. Second, it introduces separate age categories for food for special medical purposes, with distinct maximum levels for infants/young children and other age groups.
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These approvals build upon dsm-firmenich’s leading portfolio of authorized HMOs in the EU, which covers all three structural classes including four representatives of fucosylated HMOs 2′-fucosyllactose (2′-FL), difucosyllactose (DFL), 3-FL and LNFP-I, two core neutral HMOs lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT), and finally two sialylated HMOs: 3′-sialyllactose (3′-SL) sodium salt and 6′-sialyllactose (6′-SL) sodium salt.
“These authorizations reflect a growing understanding of HMOs’ potential benefits in early life and beyond infancy, creating unprecedented opportunities for tailored nutrition solutions,” Dr Christoph Röhrig, Head of the Global HMO Regulatory Affairs team at dsm-firmenich, commented. “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.”
Dr Marta Miks, Senior Regulatory & Scientific Affairs Manager at dsm-firmenich, added: “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. 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.”
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