dsm-Firmenich, a leading innovator in health, nutrition, and beauty, has announced the successful attainment of market access for its 3-fucosyllactose (3-FL) human milk oligosaccharide(HMO) ingredient in the European Union(EU). The European Commission has granted approval for the use of 3-FL as a novel food ingredient in the EU, following a Novel Food application by Glycom A/S*. This breakthrough marks a significant stride towards expanding market access for a broader portfolio of high-quality HMO products intended for use in early life nutrition, conventional food, and dietary supplements.
This noteworthy achievement comes on the heels of the recent release of 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 opinion affirms the status of 3-FL, produced by a derivative strain of Escherichia coli K-12 DH1, as a novel food in accordance with Regulation 2015/2283.
DSM-Firmenich’s 3-FL, commercially marketed as GlyCare 3FL 9001, has received authorization for use in various foods, including infant formula, follow-on formula, conventional foods, food for special medical purposes, and food supplements. Significantly, the 3-FL ingredient has been granted a higher maximum use level of 1.75g/L for use in infant and follow-on formula, in contrast to the previously approved levels for other 3-FL manufacturers, ranging from 0.85 to 1.20 g/L. The distinction in approved use levels across these food categories will be upheld throughout the five-year exclusive approval period granted to DSM-Firmenich’s 3-FL. Following the expiration of this exclusivity period, the highest approved use level will apply universally across all approved 3-FL sources. The authorization of the elevated use level was facilitated by DSM-Firmenich’s recent review of the mean concentration of HMOs in global pooled human milk, which included updated summary statistics for 3-FL.
Christoph Röhrig, Head of the global HMO Regulatory Affairs team at DSM-Firmenich, commented, “As a company committed to creating healthier product choices, we are thrilled to be at the forefront of advancements in early life nutrition with our science-backed 3-FL ingredient. 3-FL is one of the most abundant fucosylated HMOs in human milk, and scientific studies have demonstrated its promising potential to support immunity, gut health, and potentially cognitive development.”
Marta Miks, Senior Regulatory & Scientific Affairs Manager at DSM-Firmenich, added, “The recent regulatory approval of 3-FL as a novel food in the EU means the ingredient joins our existing authorized portfolio of six HMOs in the region, including 2’-fucosyllactose (2′-FL), lacto-N-neotetraose (LNnT), difucosyllactose (DFL), lacto-N-tetraose (LNT), 3’-sialyllactose (3’-SL) sodium salt, and 6’-sialyllactose (6’-SL) sodium salt. 3-FL stands out among other fucosylated HMOs as a distinctive component found in all maternal milks worldwide because, unlike most HMOs, 3-FL levels exhibit a gradual increase throughout the course of lactation. The addition of 3-FL may not only bring formula products closer to that of human breast milk but also creates an opportunity for tailored innovation in age-appropriate solutions for early life nutrition. This is especially exciting as emerging evidence indicates that HMOs may support the gut microbiota and immunity across the lifespan.
“As an end-to-end partner and the global leader in HMO regulatory approvals, we are immensely proud to be leading the way in HMO innovation and look forward to supporting more customers in the EU with HMO customized solutions and expert services.”