The EU Commission (EC) has granted Novel Food status to Danish biotechnology company Glycom for its 2’-Fucosyllactose/Difucosyllactose mixture (2’-FL/DFL). Having received the European Food Safety Authority’s (EFSA) recommendation, the EC concluded that the 2’-FL/DFL blend is safe for consumption in certain applications. With this greenlight, Glycom can now use this Human Milk Oligosaccharide (HMO) in a variety of uses on the EU market, including as a dietary supplement and in infant formula.
“We are excited to have received EFSA approval for one more HMO. At Glycom, we continue to expand our HMO portfolio and expect additional HMOs approved shortly. We can now extend our leadership position in the HMO industry,” Odd Erik Hansen, CEO at Glycom, tells.
The EC assessed Glycom had sufficiently substantiated the fulfilment for the Novel Food Status requirements. According to Innova Market Insights, the global infant formula market is expected to reach US$79 billion by 2020. The new HMO blend is available for sale immediately and Glycom hopes to see the new HMOs in new end-products in the future, Hansen adds.
The HMO has now been deemed safe for use at a maximum level of 1.6 g per L in infant formula, as long as the product is ready for use (either in terms of marketing or instructed reconstitution.) In follow-on formula, up to 1.2 g per L may be used in ready for use products.
It can also be used at a maximum level of 2 g per L in unflavored pasteurized and unflavored sterilized milk products, flavored and unflavored fermented milk-based products, as well as flavored drinks. It can be used in cereal bars at a maximum level of 20 g per kg and as a total diet replacement food for weight control and food supplements (excluding infants), both at less than 4 g per day. Glycom’s request was originally made in April 2018.
In the same request, the company also requested that the EC protect proprietary data for a number of studies submitted in support of the application. These included analytical reports on the structure comparison of 2’-FL and DFL, characterization data on the production bacterial strains and their certificates, specifications for raw materials, analytical methods and other reports. However, the EFSA notes that much of this data was crucial for determining the safety of 2’-FL/DFL.
2’-FL/DFL is obtained by microbial fermentation with a genetically modified strain of Escherichia coli strain K12 DH1. Currently, there are three HMOs available: Lacto-N-neotetraose (LNnT) , 2’FL and DFL. These are hypoallergenic, kosher and halal. Moreover, they are free from Bisphenol-A (BPA), latex and GMO. The company projects three more to be launched in mid-2020.
Health benefits
At approximately 2 g per liter, 2’FL is the most abundant fucosylated HMO in human milk and studies point to its preventative role in gut infections. The ingredient is also touted as improving gut barrier and gut regulation as well as supporting cognitive development.
Alongside 2’FL, DFL is also a highly abundant fucosylated HMO with anti-infective benefits that help inhibit the adhesion of pathogenic bacteria. DFL also supports gut health by selectively stimulating bifidobacteria.
According to Glycom, HMOs show significant benefits for infants in milk formula. Babies who received infant formula with HMOs had significantly less bronchitis and fewer respiratory tract infections. Moreover, fortifying the infant formula with HMOs resulted in babies using fewer antibiotics and fewer antipyretics, or fever-reducing medicine. The study measured the results in 175 healthy newborns with infant formula containing 2’FL and LNnT.
A recent DuPont study additionally found that its product Care4U 2’-FL beneficially changes microbiota composition and the production of microbial metabolites compared to galacto-oligosaccharides (GOS) and lactose.
Human milk is composed of lactose, lipids, oligosaccharides and proteins. No other mammal has anywhere near the high concentration and complexity of oligosaccharides in their milk, Glycom says. Therefore, HMOs are a crucial starting point for healthy infant nutrition.
