Expanding infant nutrition: dsm-firmenich’s 3-FL HMO gets EU market green light

13 Dec 2023 --- Health and nutrition player, dsm-firmenich reveals it has been granted EU market access for its novel 3-fucosyllactose (3-FL) human milk oligosaccharide (HMO) ingredient. This development comes as the European Commission (EC) has also approved 3-FL as a novel food ingredient, following a successful application submitted by Glycom.

It also comes on the heels of approval of the company’s 2’-fucosyllactose (2’-FL) and lacto-N-neotetraose (LNnT) HMOs receiving approval as infant nutrition fortifiers in China — a milestone the company said was years in the making.

“As a company devoted to creating healthier product choices, we’re excited to be at the forefront of advancements in early life nutrition (ELN) with our science-backed 3-FL ingredient,” says Christoph Röhrig, head of the global HMO regulatory affairs team at dsm-firmenich. 

“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’-FL, LNnT, difucosyllactose (DFL), lacto-N-tetraose (LNT), 3’-sialyllactose (3’-SL) sodium salt and 6’-sialyllactose (6’-SL) sodium salt,” explains Marta Miks, the company’s senior regulatory and scientific affairs manager.

Closer to human milk
Earlier this year, Nutrition Insight spoke with James Young, dsm-firmenich’s VP of ELN, about the need for infant formula ingredients to be as close as possible to breast milk, the “gold standard” of infant nutrition.

At the same time, the company highlights 3-FL as the most abundant fucosylated HMO in human milk and says the ingredient has shown considerable promise in scientific research for bolstering immunity and improving gut health and may even aid in cognitive development.

“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,” Miks reveals. “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.”

The approval means dsm-firmenich’s 3-FL is authorized in foods and supplements that extend beyond infant nutrition.

Expansive approvals
According to the company, the EC’s decision is backed by the European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods and Food Allergens. The EFSA published a positive Scientific Opinion endorsing 3-FL at the end of April of 2023.

The 3-FL strain, marketed under the name GlyCare 3FL 9001, is now authorized for inclusion in several food products, including infant formula, follow-on formula, conventional foods, food for special medical purposes and dietary supplements. 

The ingredient is produced using a derivative strain of Escherichia coli K-12 DH1 and has an approved higher maximum usage level of 1.75 g/L in infant and follow-on formulas. This level surpasses the previously sanctioned ranges of 0.85–1.20 g/L granted to other manufacturers of 3-FL. 

The company highlights that the differentiation in approved levels will remain in effect throughout the five-year exclusive approval period awarded 3-FL. Following this period, the highest approved level will become the standard for all approved 3-FL sources.

Moreover, the authorization for the increased usage level stems from dsm-firmenich’s recent research into the mean concentration of HMOs in globally pooled human milk. The study included updated summary statistics specifically for 3-FL, providing a basis for the revised usage guidelines.

“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,” Miks concludes.

By William Bradford Nichols