Cargando…

Safety evaluation of the food enzyme cellulase from Trichoderma reesei (strain DP‐Nzc36)

The food enzyme cellulase (4‐(1,3;1,4)‐beta‐D‐glucan 4‐glucanohydrolase; EC 3.2.1.4) is produced with the genetically modified Trichoderma reesei strain DP‐Nzc36 by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the product...

Descripción completa

Detalles Bibliográficos
Autores principales: Silano, Vittorio, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mortensen, Alicja, Riviere, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Marcon, Francesca, Gomes, Ana, Kovalkovičová, Natália, Liu, Yi, Maia, Joaquim, Chesson, Andrew
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008798/
https://www.ncbi.nlm.nih.gov/pubmed/32626137
http://dx.doi.org/10.2903/j.efsa.2019.5839
_version_ 1783495533512359936
author Silano, Vittorio
Barat Baviera, José Manuel
Bolognesi, Claudia
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David Michael
Grob, Konrad
Lampi, Evgenia
Mortensen, Alicja
Riviere, Gilles
Steffensen, Inger‐Lise
Tlustos, Christina
van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Herman, Lieve
Marcon, Francesca
Gomes, Ana
Kovalkovičová, Natália
Liu, Yi
Maia, Joaquim
Chesson, Andrew
author_facet Silano, Vittorio
Barat Baviera, José Manuel
Bolognesi, Claudia
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David Michael
Grob, Konrad
Lampi, Evgenia
Mortensen, Alicja
Riviere, Gilles
Steffensen, Inger‐Lise
Tlustos, Christina
van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Herman, Lieve
Marcon, Francesca
Gomes, Ana
Kovalkovičová, Natália
Liu, Yi
Maia, Joaquim
Chesson, Andrew
collection PubMed
description The food enzyme cellulase (4‐(1,3;1,4)‐beta‐D‐glucan 4‐glucanohydrolase; EC 3.2.1.4) is produced with the genetically modified Trichoderma reesei strain DP‐Nzc36 by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The food enzyme is intended to be used in distilled alcohol production, starch processing for the production of glucose syrups and brewing processes. Since residual amounts of the food enzyme are removed by distillation and starch processing, no dietary exposure was calculated for these food processes. Based on the maximum use levels recommended for brewing processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 0.131 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of at least 97.6 mg TOS/kg bw per day which, compared to the estimated dietary exposure, results in a margin of exposure of at least 745. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure can be excluded in distilled alcohol production and is considered to be low when the enzyme is used in starch processing and brewing processes. 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-7008798
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher John Wiley and Sons Inc.
record_format MEDLINE/PubMed
spelling pubmed-70087982020-07-02 Safety evaluation of the food enzyme cellulase from Trichoderma reesei (strain DP‐Nzc36) Silano, Vittorio Barat Baviera, José Manuel Bolognesi, Claudia Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mortensen, Alicja Riviere, Gilles Steffensen, Inger‐Lise Tlustos, Christina van Loveren, Henk Vernis, Laurence Zorn, Holger Herman, Lieve Marcon, Francesca Gomes, Ana Kovalkovičová, Natália Liu, Yi Maia, Joaquim Chesson, Andrew EFSA J Scientific Opinion The food enzyme cellulase (4‐(1,3;1,4)‐beta‐D‐glucan 4‐glucanohydrolase; EC 3.2.1.4) is produced with the genetically modified Trichoderma reesei strain DP‐Nzc36 by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The food enzyme is intended to be used in distilled alcohol production, starch processing for the production of glucose syrups and brewing processes. Since residual amounts of the food enzyme are removed by distillation and starch processing, no dietary exposure was calculated for these food processes. Based on the maximum use levels recommended for brewing processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 0.131 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of at least 97.6 mg TOS/kg bw per day which, compared to the estimated dietary exposure, results in a margin of exposure of at least 745. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure can be excluded in distilled alcohol production and is considered to be low when the enzyme is used in starch processing and brewing processes. 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. 2019-10-18 /pmc/articles/PMC7008798/ /pubmed/32626137 http://dx.doi.org/10.2903/j.efsa.2019.5839 Text en © 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the http://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
Silano, Vittorio
Barat Baviera, José Manuel
Bolognesi, Claudia
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David Michael
Grob, Konrad
Lampi, Evgenia
Mortensen, Alicja
Riviere, Gilles
Steffensen, Inger‐Lise
Tlustos, Christina
van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Herman, Lieve
Marcon, Francesca
Gomes, Ana
Kovalkovičová, Natália
Liu, Yi
Maia, Joaquim
Chesson, Andrew
Safety evaluation of the food enzyme cellulase from Trichoderma reesei (strain DP‐Nzc36)
title Safety evaluation of the food enzyme cellulase from Trichoderma reesei (strain DP‐Nzc36)
title_full Safety evaluation of the food enzyme cellulase from Trichoderma reesei (strain DP‐Nzc36)
title_fullStr Safety evaluation of the food enzyme cellulase from Trichoderma reesei (strain DP‐Nzc36)
title_full_unstemmed Safety evaluation of the food enzyme cellulase from Trichoderma reesei (strain DP‐Nzc36)
title_short Safety evaluation of the food enzyme cellulase from Trichoderma reesei (strain DP‐Nzc36)
title_sort safety evaluation of the food enzyme cellulase from trichoderma reesei (strain dp‐nzc36)
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008798/
https://www.ncbi.nlm.nih.gov/pubmed/32626137
http://dx.doi.org/10.2903/j.efsa.2019.5839
work_keys_str_mv AT safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT silanovittorio safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT baratbavierajosemanuel safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT bolognesiclaudia safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT cocconcellipiersandro safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT crebelliriccardo safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT gottdavidmichael safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT grobkonrad safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT lampievgenia safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT mortensenalicja safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT rivieregilles safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT steffenseningerlise safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT tlustoschristina safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT vanloverenhenk safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT vernislaurence safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT zornholger safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT hermanlieve safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT marconfrancesca safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT gomesana safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT kovalkovicovanatalia safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT liuyi safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT maiajoaquim safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36
AT chessonandrew safetyevaluationofthefoodenzymecellulasefromtrichodermareeseistraindpnzc36