UK and EU grant dsm-firmenich’s GlyCare 3-FL and LNFP-I/2'-FL HMOs novel food ingredients approval

03 Sep 2024 --- GlyCare 3FL 9001 and GlyCare LNFP-I/2FL 8001 by dsm-firmenich are the human milk oligosaccharides (HMOs) 3-fucosyllactose (3-FL) and the lacto-N-fucopentaose I/2’-fucosyllactose (LNFP-I/2’-FL) mixture. The HMOs have been approved by the UK and EU as novel food ingredients.

“These authorizations reflect a growing understanding of HMOs’ potential benefits in early life and beyond infancy, creating unprecedented opportunities for tailored nutrition solutions,” comments Dr. Christoph Röhrig, head of the global 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.”

Dr. Marta Miks, senior regulatory and scientific affairs manager at dsm-firmenich, adds: “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.”

With these approvals, GlyCare 3FL 9001 and GlyCare LNFP-I/2FL 8001 can be used in a wide range of food categories, including infant formula, follow-on formula, conventional foods, nutrition for medical purposes and dietary supplements.

Novel food ingredients

According to dsm-firmenich, the new approval signifies the expanding potential of HMO applications across life stages. The company is now the first and only supplier to receive approval for LNFP-I. This is a milestone in HMO innovation and availability.

GlyCare 3FL 9001 and GlyCare LNFP-I/2FL 8001 can now be used in a wide range of food categories across the UK and EU.This marks the first time the UK’s Food Standards Agency and Food Standards Scotland have permitted the use of such HMOs in supplements for infants and young children. This could open up new possibilities for supporting early-life nutrition from birth. This is also the first post-Brexit approval of HMOs in the country.

“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,” Miks comments.

Meanwhile, the EU’s authorization represents two new developments. Firstly, it removes age restrictions to young children for milk-based drinks and similar products, broadening the application potential to all age groups. Secondly, the EU is introducing separate age categories for food for special medical purposes, with distinct maximum levels for infants and young children, and other age groups.

The European Commission first approved dsm-firmenich’s 3-FL for the EU market in December of last year. 

HMO approvals

Since the approval, dsm-firmenich’s portfolio of authorized HMOs in the EU covers all three structural classes, including four representatives of fucosylated HMOs: 2’-FL (2’-fucosyllactose), DFL (difucosyllactose), 3-FL and LNFP-I. 

It also includes two core neutral HMOs — LNT (lacto-N-tetraose) and LNnT (lacto-N-neotetraose) — and two sialylated HMOs: 3’-SL (3’-sialyllactose) sodium salt and 6’-SL (6’-sialyllactose) sodium salt.

“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,” Miks asserts.

In the US, dsm-firmenich’s LNFP-I/2’-FL and the hypoallergenic grade LNnT and 2’FL received approval from the FDA last year.

China’s National Center for Food Safety Risk Assessment also cleared the GlyCare 3’-SL and 6’-SL for sale and use in 2023.

Food Standards Australia New Zealand gave the green light to 2’-FL and LNnT at the start of this year.