dsm-firmenich has received UK and EU approval for its human milk oligosaccharide (HMO) mixture as a novel food ingredient.
Its HMO combination of 3-fucosyllactose (3-FL) and laco-N-fucopentaose I/2'-fucosyllactose (LNFP-I/2'-FL) can now be feely incorporated into supplements for infants and young children.
dsm-firmenich is the first and only supplier to receive approval for LNFP-I, marking a milestone in HMO market availability for early life nutrition.
The UK approval will become effective by June 28, 2024, and will cover both 3-FL, LNFP-I/2'-FL and a mixture of the two.
The European Commission will allow for the marketing of GlyCare 3FL 9001 and GlyCare LNFP-I/2FL 8001 across a range of food categories, including:
- Infant formulas
- Conventional foods
- Foods for medical indications
- Supplements
The novel approval will also remove the restrictions placed on milk-based drinks for young children.
dsm's head of Global HMO Regulatory Affairs, Dr Christoph Röhrig, commented: "These authorisations reflect a growing understanding of HMOs' potential benefits in early life and beyond infancy, creating unprecedented opportunities for tailored nutrition solutions,"
"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 authorisation 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."
"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."