Cargando…

Safety of 2’‐fucosyllactose/difucosyllactose mixture as a novel food pursuant to Regulation (EU) 2015/2283

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 mainl...

Descripción completa

Detalles Bibliográficos
Autores principales: Turck, Dominique, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Kearney, John, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Cubadda, Francesco, Engel, Karl Heinz, Frenzel, Thomas, Heinonen, Marina, Marchelli, Rosangela, Neuhäuser‐Berthold, Monika, Pöting, Annette, Poulsen, Morten, Sanz, Yolanda, Schlatter, Josef Rudolf, van Loveren, Henk, Sun, Qingqing, Turla, Emanuela, Knutsen, Helle Katrine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009083/
https://www.ncbi.nlm.nih.gov/pubmed/32626339
http://dx.doi.org/10.2903/j.efsa.2019.5717
_version_ 1783495587582181376
author Turck, Dominique
Castenmiller, Jacqueline
De Henauw, Stefaan
Hirsch‐Ernst, Karen Ildico
Kearney, John
Maciuk, Alexandre
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Pelaez, Carmen
Pentieva, Kristina
Siani, Alfonso
Thies, Frank
Tsabouri, Sophia
Vinceti, Marco
Cubadda, Francesco
Engel, Karl Heinz
Frenzel, Thomas
Heinonen, Marina
Marchelli, Rosangela
Neuhäuser‐Berthold, Monika
Pöting, Annette
Poulsen, Morten
Sanz, Yolanda
Schlatter, Josef Rudolf
van Loveren, Henk
Sun, Qingqing
Turla, Emanuela
Knutsen, Helle Katrine
author_facet Turck, Dominique
Castenmiller, Jacqueline
De Henauw, Stefaan
Hirsch‐Ernst, Karen Ildico
Kearney, John
Maciuk, Alexandre
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Pelaez, Carmen
Pentieva, Kristina
Siani, Alfonso
Thies, Frank
Tsabouri, Sophia
Vinceti, Marco
Cubadda, Francesco
Engel, Karl Heinz
Frenzel, Thomas
Heinonen, Marina
Marchelli, Rosangela
Neuhäuser‐Berthold, Monika
Pöting, Annette
Poulsen, Morten
Sanz, Yolanda
Schlatter, Josef Rudolf
van Loveren, Henk
Sun, Qingqing
Turla, Emanuela
Knutsen, Helle Katrine
collection PubMed
description 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.
format Online
Article
Text
id pubmed-7009083
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher John Wiley and Sons Inc.
record_format MEDLINE/PubMed
spelling pubmed-70090832020-07-02 Safety of 2’‐fucosyllactose/difucosyllactose mixture as a novel food pursuant to Regulation (EU) 2015/2283 Turck, Dominique Castenmiller, Jacqueline De Henauw, Stefaan Hirsch‐Ernst, Karen Ildico Kearney, John Maciuk, Alexandre Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Pelaez, Carmen Pentieva, Kristina Siani, Alfonso Thies, Frank Tsabouri, Sophia Vinceti, Marco Cubadda, Francesco Engel, Karl Heinz Frenzel, Thomas Heinonen, Marina Marchelli, Rosangela Neuhäuser‐Berthold, Monika Pöting, Annette Poulsen, Morten Sanz, Yolanda Schlatter, Josef Rudolf van Loveren, Henk Sun, Qingqing Turla, Emanuela Knutsen, Helle Katrine EFSA J Scientific Opinion 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. John Wiley and Sons Inc. 2019-06-11 /pmc/articles/PMC7009083/ /pubmed/32626339 http://dx.doi.org/10.2903/j.efsa.2019.5717 Text en © 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.
spellingShingle Scientific Opinion
Turck, Dominique
Castenmiller, Jacqueline
De Henauw, Stefaan
Hirsch‐Ernst, Karen Ildico
Kearney, John
Maciuk, Alexandre
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Pelaez, Carmen
Pentieva, Kristina
Siani, Alfonso
Thies, Frank
Tsabouri, Sophia
Vinceti, Marco
Cubadda, Francesco
Engel, Karl Heinz
Frenzel, Thomas
Heinonen, Marina
Marchelli, Rosangela
Neuhäuser‐Berthold, Monika
Pöting, Annette
Poulsen, Morten
Sanz, Yolanda
Schlatter, Josef Rudolf
van Loveren, Henk
Sun, Qingqing
Turla, Emanuela
Knutsen, Helle Katrine
Safety of 2’‐fucosyllactose/difucosyllactose mixture as a novel food pursuant to Regulation (EU) 2015/2283
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 Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009083/
https://www.ncbi.nlm.nih.gov/pubmed/32626339
http://dx.doi.org/10.2903/j.efsa.2019.5717
work_keys_str_mv AT safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT turckdominique safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT castenmillerjacqueline safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT dehenauwstefaan safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT hirschernstkarenildico safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT kearneyjohn safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT maciukalexandre safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT mangelsdorfinge safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT mcardleharryj safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT naskaandroniki safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT pelaezcarmen safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT pentievakristina safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT sianialfonso safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT thiesfrank safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT tsabourisophia safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT vincetimarco safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT cubaddafrancesco safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT engelkarlheinz safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT frenzelthomas safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT heinonenmarina safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT marchellirosangela safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT neuhauserbertholdmonika safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT potingannette safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT poulsenmorten safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT sanzyolanda safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT schlatterjosefrudolf safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT vanloverenhenk safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT sunqingqing safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT turlaemanuela safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283
AT knutsenhellekatrine safetyof2fucosyllactosedifucosyllactosemixtureasanovelfoodpursuanttoregulationeu20152283