51. Safety of 6'-sialyllactose (6'-SL) sodium salt produced by a derivative strain ( Escherichia coli NEO6) of E. coli W (ATCC 9637) as a Novel Food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Aguilera-Gómez M, Cubadda F, Frenzel T, Heinonen M, Prieto Maradona M, Marchelli R, Neuhäuser-Berthold M, Poulsen M, Schlatter JR, Siskos A, van Loveren H, Colombo P, Noriega Fernández E, and Knutsen HK
- Abstract
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 6'-sialyllactose (6'-SL) sodium salt as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharide (HiMO) 6'-SL (sodium salt), but it also contains sialic acid, d-glucose, d-lactose, 6'-sialyllactulose sodium salt, 3'-sialyllactose (3'-SL) sodium salt and a small fraction of other related saccharides. The NF is produced by fermentation by a genetically modified strain ( Escherichia coli NEO6) of E. coli W (ATCC 9637). The information provided on the identity, manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF to a variety of foods, including infant formula and follow-on formula, food for special medical purposes and food supplements (FS). The target population is the general population. The applicant applies for the same uses and use levels already assessed for 6'-SL sodium salt produced by fermentation by a genetically modified strain of E. coli K-12 DH1. Therefore, since the NF would be consumed at the same extent as the already assessed 6'-SL sodium salt, no new estimates of the intake have been carried out. Similarly, FS are not intended to be used if other foods with added 6'-SL or human milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)
- Published
- 2023
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