Safety of the extension of use of 2’‐fucosyllactose (2’‐FL) and lacto‐N‐neotetraose (LNnT) as novel foods in food supplements for infants pursuant to Regulation (EU) 2015/2283

• Published in: EFSA journal Vol. 20; no. 5; pp. e07257 - n/a
• Main Authors: Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Marchelli, Rosangela, Neuhäuser‐Berthold, Monika, Poulsen, Morten, Prieto Maradona, Miguel, Schlatter, Josef Rudolf, Loveren, Henk, Colombo, Paolo, Noriega Fernández, Estefanía, Knutsen, Helle Katrine
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 01-05-2022; European Food Safety Authority; John Wiley and Sons Inc; Wiley
• Series: EFSA Journal
• Subjects: 2’‐FL; Allergens; Body weight; Breast milk; Dietary supplements; E coli; extension of use; Fermentation; Food; Food allergies; food supplement; Genetic modification; HiMO; Infants; Life Sciences; LNnT; Manufacturers; Milk; Novel Foods; Nutrition; Population; Proprietary; Safety; Scientific Opinion; HiMO; Novel Foods; infants; food supplement; LNnT; extension of use; 2’‐FL; 2'-FL
• ISSN: 1831-4732; 1831-4732; 2314-9396
• DOI: 10.2903/j.efsa.2022.7257

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of the extensions of use of the authorised novel foods (NFs) 2’‐fucosyllactose (2’‐FL) and lacto‐N‐neotetraose (LNnT) in food supplements (FS) for infants pursuant to Regulation (EU) 2015/2283. The NFs are produced by fermentation with genetically modified strains of Escherichia coli K‐12 and already included in the EU list of NFs. The applicant stated that no changes in the production process or the identity of the NFs occurred. The applicant proposes an extension of use of the NF containing 2’‐FL in FS intended for infants (< 1 year), at a maximum use level of 1.2 g/day. The applicant also proposes an extension of use of LNnT in FS intended for infants, at a maximum use level of 0.6 g/day. The intake of 2’‐FL per kg body weight from the proposed maximum use levels in FS for infants is lower than the lowest estimated mean intake of naturally occurring 2’‐FL from human milk. Similarly, the intake of LNnT per kg body weight is lower than the highest estimated mean intake of naturally occurring 2’‐FL from human milk. Furthermore, the Panel notes that the proposed uses of 2’‐FL in FS for infants are lower than the estimated intake from the already authorised uses of the NF for the same population group. The Panel also notes that the proposed uses of LNnT in FS for infants are similar to the estimated intake from the already authorised uses of the NF for the same population group. The Panel concludes that the use of the NFs containing 2’‐FL or LNnT in FS for infants is safe under the proposed conditions of use.