DSM-Firmenich secures 3-Fucosyllactose market access paving way for advanced nutrition in the EU

NETHERLANDS – DSM-Firmenich, a renowned innovator in health and nutrition has successfully secured market access for its 3-fucosyllactose (3-FL) human milk oligosaccharide (HMO) ingredient in the European Union (EU).

The achievement comes on the heels of the European Commission’s approval of 3-FL as a novel food ingredient in the EU, facilitated by a Novel Food application by Glycom A/S.

The approval is a pivotal step forward, unlocking opportunities for DSM-Firmenich to expand its portfolio of high-quality HMO products across various segments, including early-life nutrition, conventional food, and dietary supplements.

This accomplishment follows a recent positive Scientific Opinion from the European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods, and Food Allergens, validating 3-FL produced by a derivative strain of Escherichia coli K-12 DH1 as a novel food in line with Regulation 2015/2283.

Commercially marketed as GlyCare 3FL 9001, DSM-Firmenich’s 3-FL has received authorization for use in a range of foods, including infant formula, follow-on formula, conventional foods, food for special medical purposes, and food supplements.

Notably, it has been granted a higher maximum use level of 1.75 g/L in infant and follow-on formula, setting it apart from other 3-FL manufacturers.

This exclusivity in approved use levels will persist for five years, after which the highest approved use level will become the standard across all sources of approved 3-FL.

The higher use level was made possible through DSM-Firmenich’s comprehensive review of the mean concentration of HMOs in global pooled human milk, including updated summary statistics for 3-FL.

Christoph Röhrig, Head of the global HMO Regulatory Affairs team at DSM-Firmenich, expressed excitement about being at the forefront of advancements in early-life nutrition.

“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,” he stated.

Marta Miks, Senior Regulatory & Scientific Affairs Manager at DSM-Firmenich, emphasized the significance of this regulatory approval, highlighting that 3-FL now joins the company’s existing authorized portfolio of six HMOs in the EU.

She noted that 3-FL stands out among other fucosylated HMOs due to its distinctive gradual increase in levels throughout lactation.

Adding 3-FL to formula products not only brings them closer to human breast milk but also opens doors for tailored innovation in age-appropriate solutions for early-life nutrition.

Emerging evidence suggests that HMOs may support 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,” Miks said.

“This regulatory approval positions DSM-Firmenich as a trailblazer in HMO innovation, promising a brighter and healthier future for early-life nutrition in the European Union.”