RT info:eu-repo/semantics/article
T1 Safety of 3′‐sialyllactose (3′‐SL) sodium salt produced by a derivative strain (Escherichia coli NEO3) of E. coli W (ATCC 9637) as a Novel Food pursuant to Regulation (EU) 2015/2283
A1 Turck, Dominique
A1 Bohn, Torsten
A1 Castenmiller, Jacqueline
A1 De Henauw, Stefaan
A1 Hirsch‐Ernst, Karen Ildico
A1 Maciuk, Alexandre
A1 Mangelsdorf, Inge
A1 McArdle, Harry J
A1 Naska, Androniki
A1 Pentieva, Kristina
A1 Siani, Alfonso
A1 Thies, Frank
A1 Tsabouri, Sophia
A1 Vinceti, Marco
A1 Aguilera Gómez, Margarita
A1 Cubadda, Francesco
A1 Frenzel, Thomas
A1 Heinonen, Marina
A1 Marchelli, Rosangela
A1 Neuhäuser‐Berthold, Monika
A1 Peláez, Carmen
A1 Poulsen, Morten
A1 Prieto Maradona, Miguel
A1 Schlatter, Josef Rudolf
A1 Siskos, Alexandros
A1 van Loveren, Henk
A1 Colombo, Paolo
A1 Noriega Fernández, Estefanía
A1 Knutsen, Helle Katrine
A2 Nutricion y Bromatologia
K1 Tecnología de los alimentos
K1 3'-sialyllactose
K1 3'-SL
K1 Sodium salt
K1 Human milk oligosaccharide
K1 HMO
K1 HiMO
K1 Novel food
K1 Safety
K1 3309 Tecnología de Los Alimentos
AB [EN] 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 3′-sialyllactose (3′-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) 3′-SL (sodium salt), but it also contains sialic acid, d-glucose, d-lactose, 3′-sialyllactulose and 6′-sialyllactose sodium salts and a small fraction of other related saccharides. The NF is produced by fermentation by a genetically modified strain (Escherichia coli NEO3) 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 as already assessed for 3′-SL sodium salt produced by a genetically modified strain of E. coli K-12 DH1, with the exception for the use in FS, which is proposed to be higher (from 0.5 to 1.0 g/day) in individuals from 3 years of age. Since the NF as a food ingredient would be consumed at the same extent as the already assessed 3′-SL sodium salt, no new estimates of the intakes have been carried out. The Panel notes that the maximum daily intake of 3′-SL from the proposed use of the NF in FS for individuals from 3 years of age (1.0 g/day) is lower than the estimated highest mean daily intake of 3′-SL in breastfed infants. FS are not intended to be used if other sources of 3′-SL are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use
PB Wiley
SN 1831-4732
LK https://hdl.handle.net/10612/20042
UL https://hdl.handle.net/10612/20042
NO Turck, D., Bohn, T., Castenmiller, J., De Henauw, S., Hirsch-Ernst, K. I., Maciuk, A., Mangelsdorf, I., McArdle, H. J., Naska, A., Pentieva, K., Siani, A., Thies, F., Tsabouri, S., Vinceti, M., Aguilera-Gómez, M., Cubadda, F., Frenzel, T., Heinonen, M., Marchelli, R., et al. (2023). Safety of 3′-sialyllactose (3′-SL) sodium salt produced by a derivative strain (Escherichia coli NEO3) of E. coli W (ATCC 9637) as a Novel Food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 21(9). https://doi.org/10.2903/J.EFSA.2023.8224
DS BULERIA. Repositorio Institucional de la Universidad de León
RD 07-jun-2024