Safety of lacto‐N‐fucopentaose I/2’‐fucosyllactose (LNFP‐I/2’‐FL) mixture as a novel food pursuant to Regulation (EU) 2015/2283

[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 lacto-N-fucopentaose I (LNFP-I)/2′-fucosyllactose (2’-FL) mixture as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly c...

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Detalhes bibliográficos
Autores: Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Prieto Maradona, Miguel, Marchelli, Rosangela, Neuhäuser‐Berthold, Monika, Peláez, Carmen, Poulsen, Morten, Schlatter, Josef Rudolf, Siskos, Alexandros, van Loveren, Henk, Colombo, Paolo, Noriega Fernández, Estefanía, Knutsen, Helle Katrine
Tipo de documento: artigo
Estado:Versão publicada
Data de publicação:2023
País:España
Recursos:Universidad de León
Repositório:BULERIA. Repositorio Institucional de la Universidad de León
OAI Identifier:oai:buleria.unileon.es:10612/20065
Acesso em linha:https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2023.8412
https://hdl.handle.net/10612/20065
Access Level:Acceso aberto
Palavra-chave:Tecnología de los alimentos
2’-FL
2′-fucosyllactose
HiMO
Human milk oligosaccharide
Lacto-N-fucopentaose I
LNFP-I
Novel food
3309 Tecnología de Los Alimentos
Descrição
Resumo:[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 lacto-N-fucopentaose I (LNFP-I)/2′-fucosyllactose (2’-FL) mixture as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharides (HiMO) LNFP-I and 2’-FL, but it also contains d-lactose, lacto-N-tetraose, difucosyllactose, 3-fucosyllactose, LNFP-I fructose isomer, 2′-fucosyl-d-lactulose, l-fucose and 2′-fucosyl-d-lactitol, and a small fraction of other related saccharides. The NF is produced by fermentation by a genetically modified strain (Escherichia coli K-12 DH1 MDO MP2173b) of E. coli K-12 DH1 (DSM 4235). 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 in a variety of foods, including infant formula (IF) and follow-on formula, foods for infants and toddlers, foods for special medical purposes and food supplements (FS). The target population is the general population. The anticipated daily intake of LNFP-I from use in IF is similar to the estimated natural mean highest daily intake in breastfed infants. Overall, the anticipated daily intake of LNFP-I from the NF as a food ingredient at the maximum proposed use levels is unlikely to exceed the intake level of breastfed infants on a body weight basis. The intake in breastfed infants on a body weight basis is expected to be safe also for other population groups. The anticipated 2’-FL intake is generally rather low. The use of the NF in FS is not intended if other foods with added NF components or human milk (for infants and young children) are consumed on the same day. The Panel concludes that the NF, a mixture of LNFP-I and 2’-FL, is safe under the proposed conditions of use

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