Safety evaluation of the food enzyme mannan endo‐1,4‐β‐mannosidase from the genetically modified Trichoderma reesei strain RF6232

Abstract 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...

Full description

Bibliographic Details
Main Authors: EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Claude Lambré, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Lieve Herman, Joaquim Maia, Natalia Kovalkovicova, Yi Liu, Simone Lunardi, Giulio diPiazza, Rita Ferreira de Sousa, Andrew Chesson
Format: Article
Language:English
Published: Wiley 2022-08-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2022.7478
_version_ 1797999755659313152
author EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
Claude Lambré
José Manuel Barat Baviera
Claudia Bolognesi
Pier Sandro Cocconcelli
Riccardo Crebelli
David Michael Gott
Konrad Grob
Evgenia Lampi
Marcel Mengelers
Alicja Mortensen
Gilles Rivière
Inger‐Lise Steffensen
Christina Tlustos
Henk Van Loveren
Laurence Vernis
Holger Zorn
Lieve Herman
Joaquim Maia
Natalia Kovalkovicova
Yi Liu
Simone Lunardi
Giulio diPiazza
Rita Ferreira de Sousa
Andrew Chesson
author_facet EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
Claude Lambré
José Manuel Barat Baviera
Claudia Bolognesi
Pier Sandro Cocconcelli
Riccardo Crebelli
David Michael Gott
Konrad Grob
Evgenia Lampi
Marcel Mengelers
Alicja Mortensen
Gilles Rivière
Inger‐Lise Steffensen
Christina Tlustos
Henk Van Loveren
Laurence Vernis
Holger Zorn
Lieve Herman
Joaquim Maia
Natalia Kovalkovicova
Yi Liu
Simone Lunardi
Giulio diPiazza
Rita Ferreira de Sousa
Andrew Chesson
author_sort EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
collection DOAJ
description Abstract 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.
first_indexed 2024-04-11T11:09:47Z
format Article
id doaj.art-88d5b865c7a44116babb17f7a831ceec
institution Directory Open Access Journal
issn 1831-4732
language English
last_indexed 2024-04-11T11:09:47Z
publishDate 2022-08-01
publisher Wiley
record_format Article
series EFSA Journal
spelling doaj.art-88d5b865c7a44116babb17f7a831ceec2022-12-22T04:27:57ZengWileyEFSA Journal1831-47322022-08-01208n/an/a10.2903/j.efsa.2022.7478Safety evaluation of the food enzyme mannan endo‐1,4‐β‐mannosidase from the genetically modified Trichoderma reesei strain RF6232EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)Claude LambréJosé Manuel Barat BavieraClaudia BolognesiPier Sandro CocconcelliRiccardo CrebelliDavid Michael GottKonrad GrobEvgenia LampiMarcel MengelersAlicja MortensenGilles RivièreInger‐Lise SteffensenChristina TlustosHenk Van LoverenLaurence VernisHolger ZornLieve HermanJoaquim MaiaNatalia KovalkovicovaYi LiuSimone LunardiGiulio diPiazzaRita Ferreira de SousaAndrew ChessonAbstract 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.https://doi.org/10.2903/j.efsa.2022.7478food enzymemannan endo‐1,4‐β‐mannosidase1,4‐β‐d‐mannan mannanohydrolaseβ‐mannanaseEC 3.2.1.78Trichoderma reesei
spellingShingle EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
Claude Lambré
José Manuel Barat Baviera
Claudia Bolognesi
Pier Sandro Cocconcelli
Riccardo Crebelli
David Michael Gott
Konrad Grob
Evgenia Lampi
Marcel Mengelers
Alicja Mortensen
Gilles Rivière
Inger‐Lise Steffensen
Christina Tlustos
Henk Van Loveren
Laurence Vernis
Holger Zorn
Lieve Herman
Joaquim Maia
Natalia Kovalkovicova
Yi Liu
Simone Lunardi
Giulio diPiazza
Rita Ferreira de Sousa
Andrew Chesson
Safety evaluation of the food enzyme mannan endo‐1,4‐β‐mannosidase from the genetically modified Trichoderma reesei strain RF6232
EFSA Journal
food enzyme
mannan endo‐1,4‐β‐mannosidase
1,4‐β‐d‐mannan mannanohydrolase
β‐mannanase
EC 3.2.1.78
Trichoderma reesei
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 food enzyme
mannan endo‐1,4‐β‐mannosidase
1,4‐β‐d‐mannan mannanohydrolase
β‐mannanase
EC 3.2.1.78
Trichoderma reesei
url https://doi.org/10.2903/j.efsa.2022.7478
work_keys_str_mv AT efsapanelonfoodcontactmaterialsenzymesandprocessingaidscep safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT claudelambre safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT josemanuelbaratbaviera safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT claudiabolognesi safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT piersandrococconcelli safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT riccardocrebelli safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT davidmichaelgott safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT konradgrob safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT evgenialampi safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT marcelmengelers safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT alicjamortensen safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT gillesriviere safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT ingerlisesteffensen safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT christinatlustos safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT henkvanloveren safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT laurencevernis safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT holgerzorn safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT lieveherman safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT joaquimmaia safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT nataliakovalkovicova safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT yiliu safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT simonelunardi safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT giuliodipiazza safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT ritaferreiradesousa safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232
AT andrewchesson safetyevaluationofthefoodenzymemannanendo14bmannosidasefromthegeneticallymodifiedtrichodermareeseistrainrf6232