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Safety of cellobiose 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 cellobiose as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of two glucose monomers linked by a β‐(1–4) glucosidic bond. T...

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Autores principales: Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Prieto Maradona, Miguel, Marchelli, Rosangela, Neuhäuser‐Berthold, Monika, Poulsen, Morten, Schlatter, Josef Rudolf, van Loveren, Henk, Albert, Océane, Knutsen, Helle Katrine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9644228/
https://www.ncbi.nlm.nih.gov/pubmed/36381122
http://dx.doi.org/10.2903/j.efsa.2022.7596
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author Turck, Dominique
Bohn, Torsten
Castenmiller, Jacqueline
De Henauw, Stefaan
Hirsch‐Ernst, Karen Ildico
Maciuk, Alexandre
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Pelaez, Carmen
Pentieva, Kristina
Siani, Alfonso
Thies, Frank
Tsabouri, Sophia
Vinceti, Marco
Cubadda, Francesco
Frenzel, Thomas
Heinonen, Marina
Prieto Maradona, Miguel
Marchelli, Rosangela
Neuhäuser‐Berthold, Monika
Poulsen, Morten
Schlatter, Josef Rudolf
van Loveren, Henk
Albert, Océane
Knutsen, Helle Katrine
author_facet Turck, Dominique
Bohn, Torsten
Castenmiller, Jacqueline
De Henauw, Stefaan
Hirsch‐Ernst, Karen Ildico
Maciuk, Alexandre
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Pelaez, Carmen
Pentieva, Kristina
Siani, Alfonso
Thies, Frank
Tsabouri, Sophia
Vinceti, Marco
Cubadda, Francesco
Frenzel, Thomas
Heinonen, Marina
Prieto Maradona, Miguel
Marchelli, Rosangela
Neuhäuser‐Berthold, Monika
Poulsen, Morten
Schlatter, Josef Rudolf
van Loveren, Henk
Albert, Océane
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 cellobiose as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of two glucose monomers linked by a β‐(1–4) glucosidic bond. The applicant intends to add the NF to a variety of foods, and to food supplements aimed at the general population 3 years and older. The information provided on the manufacturing process, composition and specifications of the NF is sufficient and does not raise safety concerns. The applicant provided a subchronic toxicological study which did not raise safety concerns. The applicant provided a human dose‐escalation study from which the Panel concludes that the consumption of 20 g per day of cellobiose (equivalent to 290 mg/kg body weight (bw) per day in a 70‐kg adult) does not raise concern regarding gastrointestinal tolerability. The maximum anticipated daily intake of cellobiose from the proposed uses is below 290 mg/kg bw per day in the target population. Considering the nature, source, compositional characterisation, and production process of the NF, as well as the toxicological data provided, the Panel considers that the NF does not raise safety concerns under the proposed conditions of use.
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spelling pubmed-96442282022-11-14 Safety of cellobiose as a novel food pursuant to regulation (EU) 2015/2283 Turck, Dominique Bohn, Torsten Castenmiller, Jacqueline De Henauw, Stefaan Hirsch‐Ernst, Karen Ildico Maciuk, Alexandre Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Pelaez, Carmen Pentieva, Kristina Siani, Alfonso Thies, Frank Tsabouri, Sophia Vinceti, Marco Cubadda, Francesco Frenzel, Thomas Heinonen, Marina Prieto Maradona, Miguel Marchelli, Rosangela Neuhäuser‐Berthold, Monika Poulsen, Morten Schlatter, Josef Rudolf van Loveren, Henk Albert, Océane 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 cellobiose as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of two glucose monomers linked by a β‐(1–4) glucosidic bond. The applicant intends to add the NF to a variety of foods, and to food supplements aimed at the general population 3 years and older. The information provided on the manufacturing process, composition and specifications of the NF is sufficient and does not raise safety concerns. The applicant provided a subchronic toxicological study which did not raise safety concerns. The applicant provided a human dose‐escalation study from which the Panel concludes that the consumption of 20 g per day of cellobiose (equivalent to 290 mg/kg body weight (bw) per day in a 70‐kg adult) does not raise concern regarding gastrointestinal tolerability. The maximum anticipated daily intake of cellobiose from the proposed uses is below 290 mg/kg bw per day in the target population. Considering the nature, source, compositional characterisation, and production process of the NF, as well as the toxicological data provided, the Panel considers that the NF does not raise safety concerns under the proposed conditions of use. John Wiley and Sons Inc. 2022-11-09 /pmc/articles/PMC9644228/ /pubmed/36381122 http://dx.doi.org/10.2903/j.efsa.2022.7596 Text en © 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://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
Bohn, Torsten
Castenmiller, Jacqueline
De Henauw, Stefaan
Hirsch‐Ernst, Karen Ildico
Maciuk, Alexandre
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Pelaez, Carmen
Pentieva, Kristina
Siani, Alfonso
Thies, Frank
Tsabouri, Sophia
Vinceti, Marco
Cubadda, Francesco
Frenzel, Thomas
Heinonen, Marina
Prieto Maradona, Miguel
Marchelli, Rosangela
Neuhäuser‐Berthold, Monika
Poulsen, Morten
Schlatter, Josef Rudolf
van Loveren, Henk
Albert, Océane
Knutsen, Helle Katrine
Safety of cellobiose as a novel food pursuant to regulation (EU) 2015/2283
title Safety of cellobiose as a novel food pursuant to regulation (EU) 2015/2283
title_full Safety of cellobiose as a novel food pursuant to regulation (EU) 2015/2283
title_fullStr Safety of cellobiose as a novel food pursuant to regulation (EU) 2015/2283
title_full_unstemmed Safety of cellobiose as a novel food pursuant to regulation (EU) 2015/2283
title_short Safety of cellobiose as a novel food pursuant to regulation (EU) 2015/2283
title_sort safety of cellobiose as a novel food pursuant to regulation (eu) 2015/2283
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9644228/
https://www.ncbi.nlm.nih.gov/pubmed/36381122
http://dx.doi.org/10.2903/j.efsa.2022.7596
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