The Muscle Mag
The European Commission has approved 3-FL as a novel food ingredient in the EU, thanks to a Novel Food application by Glycom A/S.
Glycom A/S considers this approval a significant achievement that will broaden market access for various high-quality HMO products in early life nutrition, conventional food, and dietary supplement sectors.
This milestone follows a positive Scientific Opinion from the European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods and Food Allergens, adopted on 27 April 2023.
The EFSA opinion confirms that 3-FL produced by a derivative strain of Escherichia coli K-12 DH1 is a novel food in compliance with Regulation 2015/2283.
dsm-firmenich’s 3-FL, marketed as GlyCare 3FL 9001, has received authorization for use in a variety of foods, including infant formula, follow-on formula, conventional foods, food for special medical purposes, and food supplements.
Notably, dsm-firmenich’s 3-FL has been granted a higher maximum use level of 1.75 g/L in infant and follow-on formula compared to other manufacturers.
This higher use level approval was based on dsm-firmenich’s review of mean HMO concentrations in global pooled human milk.
Christoph Röhrig, Head of the global HMO Regulatory Affairs team at dsm-firmenich, believes the higher use level offers manufacturers the opportunity to create products that support immunity, gut health, and potentially cognitive development.
Marta Miks, Senior Regulatory & Scientific Affairs Manager at dsm-firmenich, highlights the significance of 3-FL joining their existing portfolio of authorized HMOs in the EU.
She emphasizes the unique properties of 3-FL among fucosylated HMOs and its potential to bridge the gap between formula products and human breast milk.
Furthermore, she notes the emerging evidence suggesting that HMOs may benefit gut microbiota and immunity across all ages.
dsm-firmenich is dedicated to HMO innovation and looks forward to offering personalized solutions and expert services to their EU customers.
