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...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| 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 |
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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 |
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article |
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publishedVersion |
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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 |
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Inglés |
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http://creativecommons.org/licenses/by-nd/4.0/ info:eu-repo/semantics/openAccess |
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http://creativecommons.org/licenses/by-nd/4.0/ |
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openAccess |
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Wiley |
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Wiley |
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Universidad de León |
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BULERIA. Repositorio Institucional de la Universidad de León |
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