Safety of 3‐fucosyllactose (3‐FL) produced by a derivative strain of Escherichia coli K‐12 DH1 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 3-fucosyllactose (3-FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligos...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Tipo de documento: | artigo |
| Estado: | Versão publicada |
| Data de publicação: | 2023 |
| País: | España |
| Recursos: | Ajuntament de Barcelona |
| Repositório: | BULERIA. Repositorio Institucional de la Universidad de León |
| OAI Identifier: | oai:buleria.unileon.es:10612/20040 |
| Acesso em linha: | https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2023.8026 https://hdl.handle.net/10612/20040 |
| Access Level: | Acceso aberto |
| Palavra-chave: | Tecnología de los alimentos 3-fucosyllactose 3-FL Human milk oligosaccharide HMO HiMO Novel food Safety 3309 Tecnología de Los Alimentos |
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Safety of 3‐fucosyllactose (3‐FL) produced by a derivative strain of Escherichia coli K‐12 DH1 as a novel food pursuant to Regulation (EU) 2015/2283Turck, DominiqueBohn, TorstenCastenmiller, JacquelineDe Henauw, StefaanHirsch‐Ernst, Karen IldicoMaciuk, AlexandreMangelsdorf, IngeMcArdle, Harry J.Naska, 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 alimentos3-fucosyllactose3-FLHuman milk oligosaccharideHMOHiMONovel foodSafety3309 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 3-fucosyllactose (3-FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharide (HiMO) 3-FL, but it also contains d-lactose, l-fucose, 3-fucosyllactulose 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 MAP1834) of E. coli K-12 DH1 (DSM 4235). The information provided on the 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 anticipated daily intake of 3-FL from both proposed and combined (authorised and proposed) uses at their respective maximum use levels in all population categories does not exceed the highest intake level of 3-FL from human milk in infants on a body weight basis. The intake of 3-FL in breastfed infants on a body weight basis is expected to be safe also for other population groups. The intake of other carbohydrate-type compounds structurally related to 3-FL is also considered of no safety concern. FS are not intended to be used if other foods with added 3-FL 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.2023.8026https://hdl.handle.net/10612/20040reponame:BULERIA. Repositorio Institucional de la Universidad de Leóninstname:Ajuntament de BarcelonaIngléshttp://creativecommons.org/licenses/by-nd/4.0/info:eu-repo/semantics/openAccessoai:buleria.unileon.es:10612/200402026-06-24T12:43:27Z |
| dc.title.none.fl_str_mv |
Safety of 3‐fucosyllactose (3‐FL) produced by a derivative strain of Escherichia coli K‐12 DH1 as a novel food pursuant to Regulation (EU) 2015/2283 |
| title |
Safety of 3‐fucosyllactose (3‐FL) produced by a derivative strain of Escherichia coli K‐12 DH1 as a novel food pursuant to Regulation (EU) 2015/2283 |
| spellingShingle |
Safety of 3‐fucosyllactose (3‐FL) produced by a derivative strain of Escherichia coli K‐12 DH1 as a novel food pursuant to Regulation (EU) 2015/2283 Turck, Dominique Tecnología de los alimentos 3-fucosyllactose 3-FL Human milk oligosaccharide HMO HiMO Novel food Safety 3309 Tecnología de Los Alimentos |
| title_short |
Safety of 3‐fucosyllactose (3‐FL) produced by a derivative strain of Escherichia coli K‐12 DH1 as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_full |
Safety of 3‐fucosyllactose (3‐FL) produced by a derivative strain of Escherichia coli K‐12 DH1 as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_fullStr |
Safety of 3‐fucosyllactose (3‐FL) produced by a derivative strain of Escherichia coli K‐12 DH1 as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_full_unstemmed |
Safety of 3‐fucosyllactose (3‐FL) produced by a derivative strain of Escherichia coli K‐12 DH1 as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_sort |
Safety of 3‐fucosyllactose (3‐FL) produced by a derivative strain of Escherichia coli K‐12 DH1 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 3-fucosyllactose 3-FL Human milk oligosaccharide HMO HiMO Novel food Safety 3309 Tecnología de Los Alimentos |
| topic |
Tecnología de los alimentos 3-fucosyllactose 3-FL Human milk oligosaccharide HMO HiMO Novel food Safety 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 3-fucosyllactose (3-FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharide (HiMO) 3-FL, but it also contains d-lactose, l-fucose, 3-fucosyllactulose 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 MAP1834) of E. coli K-12 DH1 (DSM 4235). The information provided on the 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 anticipated daily intake of 3-FL from both proposed and combined (authorised and proposed) uses at their respective maximum use levels in all population categories does not exceed the highest intake level of 3-FL from human milk in infants on a body weight basis. The intake of 3-FL in breastfed infants on a body weight basis is expected to be safe also for other population groups. The intake of other carbohydrate-type compounds structurally related to 3-FL is also considered of no safety concern. FS are not intended to be used if other foods with added 3-FL 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 |
| status_str |
publishedVersion |
| dc.identifier.none.fl_str_mv |
https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2023.8026 https://hdl.handle.net/10612/20040 |
| url |
https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2023.8026 https://hdl.handle.net/10612/20040 |
| 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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reponame:BULERIA. Repositorio Institucional de la Universidad de León instname:Ajuntament de Barcelona |
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Ajuntament de Barcelona |
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BULERIA. Repositorio Institucional de la Universidad de León |
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BULERIA. Repositorio Institucional de la Universidad de León |
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15.228081 |