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

[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 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-identica...

Descripción completa

Detalles Bibliográficos
Autores: Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Peláez, Carmen, 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, Poulsen, Morten, Schlatter, Josef Rudolf, Siskos, Alexandros, van Loveren, Henk, Colombo, Paolo, Noriega Fernández, Estefanía, Knutsen, Helle Katrine
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Institución:Universidad de León
Repositorio:BULERIA. Repositorio Institucional de la Universidad de León
OAI Identifier:oai:buleria.unileon.es:10612/20043
Acceso en línea:https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2023.8025
https://hdl.handle.net/10612/20043
Access Level:acceso abierto
Palabra clave:Tecnología de los alimentos
6-sialyllactose
6'-SL
Sodium salt
Human milk oligosaccharide
HMO
HiMO
Novel food
3309 Tecnología de Los Alimentos
id ES_dc1c57b09d683ed2d9eb88f6bd45a602
oai_identifier_str oai:buleria.unileon.es:10612/20043
network_acronym_str ES
network_name_str España
repository_id_str
spelling 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) 2015/2283Turck, DominiqueBohn, TorstenCastenmiller, JacquelineDe Henauw, StefaanHirsch‐Ernst, Karen IldicoMaciuk, AlexandreMangelsdorf, IngeMcArdle, Harry JNaska, AndronikiPeláez, CarmenPentieva, KristinaSiani, AlfonsoThies, FrankTsabouri, SophiaVinceti, MarcoAguilera Gómez, MargaritaCubadda, FrancescoFrenzel, ThomasHeinonen, MarinaPrieto Maradona, MiguelMarchelli, RosangelaNeuhäuser‐Berthold, MonikaPoulsen, MortenSchlatter, Josef RudolfSiskos, Alexandrosvan Loveren, HenkColombo, PaoloNoriega Fernández, EstefaníaKnutsen, Helle KatrineTecnología de los alimentos6-sialyllactose6'-SLSodium saltHuman milk oligosaccharideHMOHiMONovel food3309 Tecnología de Los Alimentos[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 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 useSIWileyNutricion y BromatologiaFacultad de Veterinaria2023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2023.8025https://hdl.handle.net/10612/20043reponame:BULERIA. Repositorio Institucional de la Universidad de Leóninstname:Universidad de LeónIngléshttp://creativecommons.org/licenses/by-nd/4.0/info:eu-repo/semantics/openAccessoai:buleria.unileon.es:10612/200432026-06-24T12:43:27Z
dc.title.none.fl_str_mv 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
title 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
spellingShingle 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
Turck, Dominique
Tecnología de los alimentos
6-sialyllactose
6'-SL
Sodium salt
Human milk oligosaccharide
HMO
HiMO
Novel food
3309 Tecnología de Los Alimentos
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
dc.creator.none.fl_str_mv Turck, Dominique
Bohn, Torsten
Castenmiller, Jacqueline
De Henauw, Stefaan
Hirsch‐Ernst, Karen Ildico
Maciuk, Alexandre
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Peláez, Carmen
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
Poulsen, Morten
Schlatter, Josef Rudolf
Siskos, Alexandros
van Loveren, Henk
Colombo, Paolo
Noriega Fernández, Estefanía
Knutsen, Helle Katrine
author Turck, Dominique
author_facet Turck, Dominique
Bohn, Torsten
Castenmiller, Jacqueline
De Henauw, Stefaan
Hirsch‐Ernst, Karen Ildico
Maciuk, Alexandre
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Peláez, Carmen
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
Poulsen, Morten
Schlatter, Josef Rudolf
Siskos, Alexandros
van Loveren, Henk
Colombo, Paolo
Noriega Fernández, Estefanía
Knutsen, Helle Katrine
author_role author
author2 Bohn, Torsten
Castenmiller, Jacqueline
De Henauw, Stefaan
Hirsch‐Ernst, Karen Ildico
Maciuk, Alexandre
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Peláez, Carmen
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
Poulsen, Morten
Schlatter, Josef Rudolf
Siskos, Alexandros
van Loveren, Henk
Colombo, Paolo
Noriega Fernández, Estefanía
Knutsen, Helle Katrine
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Nutricion y Bromatologia
Facultad de Veterinaria
dc.subject.none.fl_str_mv Tecnología de los alimentos
6-sialyllactose
6'-SL
Sodium salt
Human milk oligosaccharide
HMO
HiMO
Novel food
3309 Tecnología de Los Alimentos
topic Tecnología de los alimentos
6-sialyllactose
6'-SL
Sodium salt
Human milk oligosaccharide
HMO
HiMO
Novel food
3309 Tecnología de Los Alimentos
description [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 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
publishDate 2023
dc.date.none.fl_str_mv 2023
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2023.8025
https://hdl.handle.net/10612/20043
url https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2023.8025
https://hdl.handle.net/10612/20043
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv http://creativecommons.org/licenses/by-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by-nd/4.0/
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Wiley
publisher.none.fl_str_mv Wiley
dc.source.none.fl_str_mv reponame:BULERIA. Repositorio Institucional de la Universidad de León
instname:Universidad de León
instname_str Universidad de León
reponame_str BULERIA. Repositorio Institucional de la Universidad de León
collection BULERIA. Repositorio Institucional de la Universidad de León
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869421738026074112
score 15,228081