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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
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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. |
format | Online Article Text |
id | pubmed-9644228 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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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