The European Commission’s approval of 3-FL for use as a novel food ingredient in the EU is a result of a Novel Food application by Glycom A/S.
The firm says this breakthrough represents “a major step towards enhancing market access for a wider portfolio of high-quality HMO products for use in the early life nutrition, conventional food and dietary supplement segments”.
This milestone follows the recent publication 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.
This opinion validates 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, received authorisation 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 ingredient has been granted a higher maximum use level of 1.75 g/L for use in infant and follow-on formula, compared to levels approved previously for other 3-FL manufacturers, which ranged from 0.85 – 1.20 g/L.
The distinction between different approved use levels in these food categories will remain in force for the duration of the five-year exclusive approval period that has been granted to dsm-firmenich’s 3-FL. Only after the exclusivity period ends, the highest approved use level will apply across all different sources of approved 3-FL.
The authorisation of the higher use level was made possible thanks to dsm-firmenich’s recent review on 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, explains this provides further opportunity for manufacturers to develop products which can support immunity, gut health and potentially cognitive development.
He says: “As a company devoted to creating healthier product choices, we’re excited 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, adds: “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.
“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’re 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.”