09.03.24
Ingredient supplier dsm-firmenich secured approvals for two of its human milk oligosaccharide (HMO) ingredients by the respective governing bodies in the UK and EU. The HMO ingredients, 3-FL and a mixture of LNFP-I and 2’-FL, were approved as novel food ingredients, and dsm-firmenich is the first and only supplier at this time to receive approval for the latter HMO.
The UK approval, effective June 28, covers both 3-FL and the LNFP-I/2’-FL mixture, which are the first two HMO approvals to take place in post-Brexit UK. Concurrently, the European Commission authorized the LNFP-I/2’-FL mixture in July 2024.
The approvals allow dsm-firmenich to market these ingredients under its Glycare brand across a wide range of food categories, including infant formula, follow-on formula, conventional foods, foods for special medical purposes, and food supplements.
The UK approval breaks ground, as it’s the first to allow for the use of these HMOs in supplements for infants and young children. The EU authorization also introduces two significant changes, by removing age restrictions to young children for milk-based drinks and similar products, and introducing separate age categories for food for special medical purposes, with distinct maximum levels for infants/young children and other age groups.
These approvals round out a portfolio of HMO ingredients approved in the EU for dsm-firmenich, which includes 2’-FL, DFL, LNFP-I, LNT, LNnT, 3’SL, and 6’-SL.
"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 HMO regulatory affairs team at dsm-firmenich. "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,” said Marta Miks, PhD, 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."
The UK approval, effective June 28, covers both 3-FL and the LNFP-I/2’-FL mixture, which are the first two HMO approvals to take place in post-Brexit UK. Concurrently, the European Commission authorized the LNFP-I/2’-FL mixture in July 2024.
The approvals allow dsm-firmenich to market these ingredients under its Glycare brand across a wide range of food categories, including infant formula, follow-on formula, conventional foods, foods for special medical purposes, and food supplements.
The UK approval breaks ground, as it’s the first to allow for the use of these HMOs in supplements for infants and young children. The EU authorization also introduces two significant changes, by removing age restrictions to young children for milk-based drinks and similar products, and introducing separate age categories for food for special medical purposes, with distinct maximum levels for infants/young children and other age groups.
These approvals round out a portfolio of HMO ingredients approved in the EU for dsm-firmenich, which includes 2’-FL, DFL, LNFP-I, LNT, LNnT, 3’SL, and 6’-SL.
"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 HMO regulatory affairs team at dsm-firmenich. "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,” said Marta Miks, PhD, 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."
