EC opinion deems HMO safe to place on market as Novel Food
Writing in the European Union’s official journal, authorities have approved Glycom’s application to use LNT in a number of milk-based products, infant formula and follow-on formula, as well as foods for special medical purposes.
In line with conditions ruling use of LNT-containing food supplements, the EC agreed with Glycom’s proposal saying, “it is necessary to inform consumers with an appropriate label that food supplements containing LNT should not be used if breast milk which naturally contains LNT and/or other foods with added LNT are consumed the same day.
EC requirements
Other conditions include a maximum LNT level of 0.8 grams per litre (g/l) in infant formula marketed as such or reconstituted as instructed by the manufacturer.
Total diet replacement foods for weight control are allowed a maximum TNT level of 2.0 g/l (beverages) and 20 g/kg for products other than beverages.
The EC also permit Glycom a maximum level of 2.0 grams per day (g/day) of LNT contained in food supplements for young children, children, adolescents, and adults.
The Danish biotech firm boasts an HMO product portfolio that includes EU-approved Glycare, 2FL and Glycare LNT.
LNT itself is a highly abundant neutral core Human Milk oligosaccharide (HMO) in human milk and can be obtained by microbial fermentation with a genetically modified strain of Escherichia coli (K12 DH1).
Proven benefits of LNT include reducing infection by inhibiting the adhesion of pathogenic bacteria and their toxins. Also, LNT can positively support gut health by selectively stimulating bifidobacteria.
2’‐FL/DFL thumbs-up
Back in June last year, EFSA reported no safety concerns with Glycom’s use of a 2’‐fucosyllactose/difucosyllactose (2’‐FL/DFL) mixture in infant formula and food supplements.
EFSA’s opinion deemed the mixture safe stating the 2’‐FL and DFL intake at proposed levels is unlikely to exceed the naturally occurring 2’‐FL and DFL levels in breastfed infants per kilogram body weight.
“Considering that 2’‐FL and DFL are naturally occurring oligosaccharides present in human milk, the history of human exposure to 2’‐FL and DFL concerns breast‐fed infants.
“The Panel notes that 2’‐FL, which is the major component of the NF, has already been assessed and authorised as a NF to be added to infant and follow‐on formulae (IF, FOF), as well as to food supplements.”
Expected to launch four additional HMOs during 2020, Glycom claim to be only fully integrated HMO provider in the world with its own product development, preclinical and clinical development, regulatory and large-scale production facilities.
Earlier this week Royal DSM announced the completion of its acquisition of Glycom for €765m that was first announced on 21 February 2020.
The Dutch multinational now intends to offer HMO-based products to the early life nutrition industry adding to its portfolio of Docosahexaenoic acid (DHA) and arachidonic acid (ARA) - fatty acids found in breast milk.
