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
Abstract 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 ol...
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Wiley
2023-06-01
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| Online Access: | https://doi.org/10.2903/j.efsa.2023.8026 |
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| author | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Dominique Turck Torsten Bohn Jacqueline Castenmiller Stefaan De Henauw Karen Ildico Hirsch‐Ernst Alexandre Maciuk Inge Mangelsdorf Harry J. McArdle Androniki Naska Carmen Pelaez Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Margarita Aguilera‐Gómez Francesco Cubadda Thomas Frenzel Marina Heinonen Miguel Prieto Maradona Rosangela Marchelli Monika Neuhäuser‐Berthold Morten Poulsen Josef Rudolf Schlatter Alexandros Siskos Henk vanLoveren Paolo Colombo Estefanía Noriega Fernández Helle Katrine Knutsen |
| author_facet | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Dominique Turck Torsten Bohn Jacqueline Castenmiller Stefaan De Henauw Karen Ildico Hirsch‐Ernst Alexandre Maciuk Inge Mangelsdorf Harry J. McArdle Androniki Naska Carmen Pelaez Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Margarita Aguilera‐Gómez Francesco Cubadda Thomas Frenzel Marina Heinonen Miguel Prieto Maradona Rosangela Marchelli Monika Neuhäuser‐Berthold Morten Poulsen Josef Rudolf Schlatter Alexandros Siskos Henk vanLoveren Paolo Colombo Estefanía Noriega Fernández Helle Katrine Knutsen |
| author_sort | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) |
| collection | DOAJ |
| description | Abstract 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. |
| format | Article |
| id | doaj-art-329ad357cb7a4bb28b94688cbc0c9c8e |
| institution | OA Journals |
| issn | 1831-4732 |
| language | English |
| publishDate | 2023-06-01 |
| publisher | Wiley |
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| series | EFSA Journal |
| spelling | doaj-art-329ad357cb7a4bb28b94688cbc0c9c8e2025-08-20T02:09:48ZengWileyEFSA Journal1831-47322023-06-01216n/an/a10.2903/j.efsa.2023.8026Safety of 3‐fucosyllactose (3‐FL) produced by a derivative strain of Escherichia coli K‐12 DH1 as a novel food pursuant to Regulation (EU) 2015/2283EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)Dominique TurckTorsten BohnJacqueline CastenmillerStefaan De HenauwKaren Ildico Hirsch‐ErnstAlexandre MaciukInge MangelsdorfHarry J. McArdleAndroniki NaskaCarmen PelaezKristina PentievaAlfonso SianiFrank ThiesSophia TsabouriMarco VincetiMargarita Aguilera‐GómezFrancesco CubaddaThomas FrenzelMarina HeinonenMiguel Prieto MaradonaRosangela MarchelliMonika Neuhäuser‐BertholdMorten PoulsenJosef Rudolf SchlatterAlexandros SiskosHenk vanLoverenPaolo ColomboEstefanía Noriega FernándezHelle Katrine KnutsenAbstract 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.https://doi.org/10.2903/j.efsa.2023.80263‐fucosyllactose3‐FLhuman milk oligosaccharideHMOHiMOnovel food |
| spellingShingle | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Dominique Turck Torsten Bohn Jacqueline Castenmiller Stefaan De Henauw Karen Ildico Hirsch‐Ernst Alexandre Maciuk Inge Mangelsdorf Harry J. McArdle Androniki Naska Carmen Pelaez Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Margarita Aguilera‐Gómez Francesco Cubadda Thomas Frenzel Marina Heinonen Miguel Prieto Maradona Rosangela Marchelli Monika Neuhäuser‐Berthold Morten Poulsen Josef Rudolf Schlatter Alexandros Siskos Henk vanLoveren Paolo Colombo Estefanía Noriega Fernández Helle Katrine Knutsen 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 EFSA Journal 3‐fucosyllactose 3‐FL human milk oligosaccharide HMO HiMO novel food |
| 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 |
| 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_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_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 |
| topic | 3‐fucosyllactose 3‐FL human milk oligosaccharide HMO HiMO novel food |
| url | https://doi.org/10.2903/j.efsa.2023.8026 |
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