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Safety evaluation of the food enzyme mannan endo‐1,4‐β‐mannosidase from the genetically modified Trichoderma reesei strain RF6232
The food enzyme mannan endo‐1,4‐β‐mannosidase (1,4‐β‐d‐mannan mannanohydrolase; EC 3.2.1.78) is produced with the genetically modified Trichoderma reesei strain RF6232 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable c...
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/PMC9393762/ https://www.ncbi.nlm.nih.gov/pubmed/36016870 http://dx.doi.org/10.2903/j.efsa.2022.7478 |
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author | Lambré, Claude Barat Baviera, José Manuel Bolognesi, Claudia Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mengelers, Marcel Mortensen, Alicja Rivière, Gilles Steffensen, Inger‐Lise Tlustos, Christina Van Loveren, Henk Vernis, Laurence Zorn, Holger Herman, Lieve Maia, Joaquim Kovalkovicova, Natalia Liu, Yi Lunardi, Simone di Piazza, Giulio Ferreira de Sousa, Rita Chesson, Andrew |
author_facet | Lambré, Claude Barat Baviera, José Manuel Bolognesi, Claudia Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mengelers, Marcel Mortensen, Alicja Rivière, Gilles Steffensen, Inger‐Lise Tlustos, Christina Van Loveren, Henk Vernis, Laurence Zorn, Holger Herman, Lieve Maia, Joaquim Kovalkovicova, Natalia Liu, Yi Lunardi, Simone di Piazza, Giulio Ferreira de Sousa, Rita Chesson, Andrew |
collection | PubMed |
description | The food enzyme mannan endo‐1,4‐β‐mannosidase (1,4‐β‐d‐mannan mannanohydrolase; EC 3.2.1.78) is produced with the genetically modified Trichoderma reesei strain RF6232 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and recombinant DNA. It is intended to be used in coffee processing, fruit and vegetable processing for juice production and for edible oil production. Since residual amounts of total organic solids (TOS) are removed during refined edible oil production by repeated washing, dietary exposure was calculated only for the remaining two food manufacturing processes. Dietary exposure to the food enzyme–TOS was estimated to be up to 0.09 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 100 mg TOS/kg bw per day, the lowest dose tested. This results in a margin of exposure above 1,100. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, in particular for individuals allergic to avocado, but the likelihood for this to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. |
format | Online Article Text |
id | pubmed-9393762 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-93937622022-08-24 Safety evaluation of the food enzyme mannan endo‐1,4‐β‐mannosidase from the genetically modified Trichoderma reesei strain RF6232 Lambré, Claude Barat Baviera, José Manuel Bolognesi, Claudia Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mengelers, Marcel Mortensen, Alicja Rivière, Gilles Steffensen, Inger‐Lise Tlustos, Christina Van Loveren, Henk Vernis, Laurence Zorn, Holger Herman, Lieve Maia, Joaquim Kovalkovicova, Natalia Liu, Yi Lunardi, Simone di Piazza, Giulio Ferreira de Sousa, Rita Chesson, Andrew EFSA J Scientific Opinion The food enzyme mannan endo‐1,4‐β‐mannosidase (1,4‐β‐d‐mannan mannanohydrolase; EC 3.2.1.78) is produced with the genetically modified Trichoderma reesei strain RF6232 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and recombinant DNA. It is intended to be used in coffee processing, fruit and vegetable processing for juice production and for edible oil production. Since residual amounts of total organic solids (TOS) are removed during refined edible oil production by repeated washing, dietary exposure was calculated only for the remaining two food manufacturing processes. Dietary exposure to the food enzyme–TOS was estimated to be up to 0.09 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 100 mg TOS/kg bw per day, the lowest dose tested. This results in a margin of exposure above 1,100. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, in particular for individuals allergic to avocado, but the likelihood for this to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. John Wiley and Sons Inc. 2022-08-22 /pmc/articles/PMC9393762/ /pubmed/36016870 http://dx.doi.org/10.2903/j.efsa.2022.7478 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 Lambré, Claude Barat Baviera, José Manuel Bolognesi, Claudia Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mengelers, Marcel Mortensen, Alicja Rivière, Gilles Steffensen, Inger‐Lise Tlustos, Christina Van Loveren, Henk Vernis, Laurence Zorn, Holger Herman, Lieve Maia, Joaquim Kovalkovicova, Natalia Liu, Yi Lunardi, Simone di Piazza, Giulio Ferreira de Sousa, Rita Chesson, Andrew Safety evaluation of the food enzyme mannan endo‐1,4‐β‐mannosidase from the genetically modified Trichoderma reesei strain RF6232 |
title | Safety evaluation of the food enzyme mannan endo‐1,4‐β‐mannosidase from the genetically modified Trichoderma reesei strain RF6232
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title_full | Safety evaluation of the food enzyme mannan endo‐1,4‐β‐mannosidase from the genetically modified Trichoderma reesei strain RF6232
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title_fullStr | Safety evaluation of the food enzyme mannan endo‐1,4‐β‐mannosidase from the genetically modified Trichoderma reesei strain RF6232
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title_full_unstemmed | Safety evaluation of the food enzyme mannan endo‐1,4‐β‐mannosidase from the genetically modified Trichoderma reesei strain RF6232
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title_short | Safety evaluation of the food enzyme mannan endo‐1,4‐β‐mannosidase from the genetically modified Trichoderma reesei strain RF6232
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title_sort | safety evaluation of the food enzyme mannan endo‐1,4‐β‐mannosidase from the genetically modified trichoderma reesei strain rf6232 |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9393762/ https://www.ncbi.nlm.nih.gov/pubmed/36016870 http://dx.doi.org/10.2903/j.efsa.2022.7478 |
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