Nutraveris

Novel food: positive opinion for two new milk oligosaccharides, the 3’-fucosyllactose and 6’-fucosyllactose

After previous authorizations on human milk oligosaccharides (HMO), EFSA was asked to evaluate the safety of two new sodium salt of HMO, the 3’-fucosyllactose (3’-FL) and the 6’-fucosyllactose (6’-FL). Both applications have been submitted by the Danish company Glycom, a leader of the HMO production.

Both the 3’-FL and the 6’-FL have been obtained by fermentation with a genetically modified strain of Escherichia coli K-12 DH1. 3’-FL and 6’FL have been fully characterized, notably by using NMR. Moreover, the application demonstrated the lack of viable cells in the final product, as the lack of protein and recombinant DNA. These two HMO were therefore considered as Novel Food, and not as GMO products.

EFSA considered that toxicological data demonstrated the lack of safety concern. The anticipated daily intakes of 3’-FL and 6’-FL from the Novel Food at the maximum proposed use levels were unlikely to exceed the intake level of naturally occurring levels in breast fed infants. EFSA considered therefore that these HMO can be used in a range of foodstuffs, such as infants and follow-on formula, but also some dairy products, cereal bars, foods for special medical purposes, or flavoured drinks. Finally, EFSA noted that conclusions could not have been reached without proprietary data, suggesting that authorizations for 3’-FL and 6’-FL will be protected for the applicant.

EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), Turck D, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Kearney J, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Engel KH, Frenzel T, Heinonen M, Marchelli R, Neuhauser-Berthold M, Poulsen M, Schlatter JR, van Loveren H, Colombo P and Knutsen HK, 2020. Scientific Opinion on the safety of 3’-Sialyllactose (3’-SL) sodium salt as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 2020;18(5):6098

EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), Turck D, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Kearney J, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Engel KH, Frenzel T, Heinonen M, Marchelli R, Neuhauser-Berthold M, Poulsen M, Schlatter JR, van Loveren H, Colombo P and Knutsen HK, 2020. Scientific Opinion on the safety of 6′-Sialyllactose (6′-SL) sodium salt as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal 2020;18(5):6097

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