Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: 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
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/PMC9393762/
https://www.ncbi.nlm.nih.gov/pubmed/36016870
http://dx.doi.org/10.2903/j.efsa.2022.7478
_version_ 1784771342284881920
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
title_full Safety evaluation of the food enzyme mannan endo‐1,4‐β‐mannosidase from the genetically modified Trichoderma reesei strain RF6232
title_fullStr Safety evaluation of the food enzyme mannan endo‐1,4‐β‐mannosidase from the genetically modified Trichoderma reesei strain RF6232
title_full_unstemmed Safety evaluation of the food enzyme mannan endo‐1,4‐β‐mannosidase from the genetically modified Trichoderma reesei strain RF6232
title_short Safety evaluation of the food enzyme mannan endo‐1,4‐β‐mannosidase from the genetically modified Trichoderma reesei strain RF6232
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
work_keys_str_mv AT safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT lambreclaude safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT baratbavierajosemanuel safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT bolognesiclaudia safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT cocconcellipiersandro safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT crebelliriccardo safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT gottdavidmichael safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT grobkonrad safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT lampievgenia safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT mengelersmarcel safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT mortensenalicja safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT rivieregilles safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT steffenseningerlise safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT tlustoschristina safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT vanloverenhenk safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT vernislaurence safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT zornholger safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT hermanlieve safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT maiajoaquim safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT kovalkovicovanatalia safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT liuyi safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT lunardisimone safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT dipiazzagiulio safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT ferreiradesousarita safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT chessonandrew safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232