Safety of 2’‐fucosyllactose/difucosyllactose mixture 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 2’‐fucosyllactose/difucosyllactose (2’‐FL/DFL) mixture as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a powdered mixt...
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| Format: | Article |
| Language: | English |
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Wiley
2019-06-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2019.5717 |
| _version_ | 1818613647308488704 |
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| author | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Dominique Turck Jacqueline Castenmiller Stefaan De Henauw Karen Ildico Hirsch‐Ernst John Kearney Alexandre Maciuk Inge Mangelsdorf Harry J McArdle Androniki Naska Carmen Pelaez Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Francesco Cubadda Karl Heinz Engel Thomas Frenzel Marina Heinonen Rosangela Marchelli Monika Neuhäuser‐Berthold Annette Pöting Morten Poulsen Yolanda Sanz Josef Rudolf Schlatter Henk vanLoveren Qingqing Sun Emanuela Turla Helle Katrine Knutsen |
| author_facet | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Dominique Turck Jacqueline Castenmiller Stefaan De Henauw Karen Ildico Hirsch‐Ernst John Kearney Alexandre Maciuk Inge Mangelsdorf Harry J McArdle Androniki Naska Carmen Pelaez Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Francesco Cubadda Karl Heinz Engel Thomas Frenzel Marina Heinonen Rosangela Marchelli Monika Neuhäuser‐Berthold Annette Pöting Morten Poulsen Yolanda Sanz Josef Rudolf Schlatter Henk vanLoveren Qingqing Sun Emanuela Turla 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 2’‐fucosyllactose/difucosyllactose (2’‐FL/DFL) mixture as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a powdered mixture mainly composed of two oligosaccharides, 2’‐FL and DFL, which are produced together by fermentation with a genetically modified strain of Escherichia coli K12. 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 in a variety of foods, including infant and follow‐on formula, foods for infants and young children, foods for special medical purposes and food supplements. The target population is the general population except for food supplements, for which the target population is individuals above 1 year of age. Since the intake of 2’‐FL and DFL from the NF at the proposed use levels is unlikely to exceed the intake level of naturally occurring 2’‐FL and DFL in breastfed infants per kilogram body weight, the Panel concludes that the NF, a mixture of 2’‐FL and DFL, is safe under the proposed conditions of use for the proposed target population. |
| first_indexed | 2024-12-16T16:05:26Z |
| format | Article |
| id | doaj.art-70b664cec3a04b3e84ac84a0eea1c66f |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-16T16:05:26Z |
| publishDate | 2019-06-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-70b664cec3a04b3e84ac84a0eea1c66f2022-12-21T22:25:22ZengWileyEFSA Journal1831-47322019-06-01176n/an/a10.2903/j.efsa.2019.5717Safety of 2’‐fucosyllactose/difucosyllactose mixture as a novel food pursuant to Regulation (EU) 2015/2283EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)Dominique TurckJacqueline CastenmillerStefaan De HenauwKaren Ildico Hirsch‐ErnstJohn KearneyAlexandre MaciukInge MangelsdorfHarry J McArdleAndroniki NaskaCarmen PelaezKristina PentievaAlfonso SianiFrank ThiesSophia TsabouriMarco VincetiFrancesco CubaddaKarl Heinz EngelThomas FrenzelMarina HeinonenRosangela MarchelliMonika Neuhäuser‐BertholdAnnette PötingMorten PoulsenYolanda SanzJosef Rudolf SchlatterHenk vanLoverenQingqing SunEmanuela TurlaHelle 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 2’‐fucosyllactose/difucosyllactose (2’‐FL/DFL) mixture as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a powdered mixture mainly composed of two oligosaccharides, 2’‐FL and DFL, which are produced together by fermentation with a genetically modified strain of Escherichia coli K12. 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 in a variety of foods, including infant and follow‐on formula, foods for infants and young children, foods for special medical purposes and food supplements. The target population is the general population except for food supplements, for which the target population is individuals above 1 year of age. Since the intake of 2’‐FL and DFL from the NF at the proposed use levels is unlikely to exceed the intake level of naturally occurring 2’‐FL and DFL in breastfed infants per kilogram body weight, the Panel concludes that the NF, a mixture of 2’‐FL and DFL, is safe under the proposed conditions of use for the proposed target population.https://doi.org/10.2903/j.efsa.2019.57172’‐fucosyllactosedifucosyllactose2’‐FLDFLoligosaccharidenovel food |
| spellingShingle | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Dominique Turck Jacqueline Castenmiller Stefaan De Henauw Karen Ildico Hirsch‐Ernst John Kearney Alexandre Maciuk Inge Mangelsdorf Harry J McArdle Androniki Naska Carmen Pelaez Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Francesco Cubadda Karl Heinz Engel Thomas Frenzel Marina Heinonen Rosangela Marchelli Monika Neuhäuser‐Berthold Annette Pöting Morten Poulsen Yolanda Sanz Josef Rudolf Schlatter Henk vanLoveren Qingqing Sun Emanuela Turla Helle Katrine Knutsen Safety of 2’‐fucosyllactose/difucosyllactose mixture as a novel food pursuant to Regulation (EU) 2015/2283 EFSA Journal 2’‐fucosyllactose difucosyllactose 2’‐FL DFL oligosaccharide novel food |
| title | Safety of 2’‐fucosyllactose/difucosyllactose mixture as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_full | Safety of 2’‐fucosyllactose/difucosyllactose mixture as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_fullStr | Safety of 2’‐fucosyllactose/difucosyllactose mixture as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_full_unstemmed | Safety of 2’‐fucosyllactose/difucosyllactose mixture as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_short | Safety of 2’‐fucosyllactose/difucosyllactose mixture as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_sort | safety of 2 fucosyllactose difucosyllactose mixture as a novel food pursuant to regulation eu 2015 2283 |
| topic | 2’‐fucosyllactose difucosyllactose 2’‐FL DFL oligosaccharide novel food |
| url | https://doi.org/10.2903/j.efsa.2019.5717 |
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