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Safety evaluation of the food enzyme pectinesterase from the genetically modified Aspergillus luchuensis strain FLZSC

The food enzyme pectinesterase (pectin pectylhydrolase, EC 3.1.1.11) is produced with the genetically modified Aspergillus luchuensis strain FLZSC by Advanced Enzyme Technologies Ltd. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells...

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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, Glandorf, Boet, Roos, Yrjö, Andryszkiewicz, Magdalena, Kovalkovicova, Natalia, Liu, Yi, Lunardi, Simone, de Sousa, Rita Ferreira, 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/PMC9728616/
https://www.ncbi.nlm.nih.gov/pubmed/36507099
http://dx.doi.org/10.2903/j.efsa.2022.7674
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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
Glandorf, Boet
Roos, Yrjö
Andryszkiewicz, Magdalena
Kovalkovicova, Natalia
Liu, Yi
Lunardi, Simone
de Sousa, Rita Ferreira
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
Glandorf, Boet
Roos, Yrjö
Andryszkiewicz, Magdalena
Kovalkovicova, Natalia
Liu, Yi
Lunardi, Simone
de Sousa, Rita Ferreira
Chesson, Andrew
collection PubMed
description The food enzyme pectinesterase (pectin pectylhydrolase, EC 3.1.1.11) is produced with the genetically modified Aspergillus luchuensis strain FLZSC by Advanced Enzyme Technologies Ltd. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in fruit and vegetable processing for the production of juices and other fruit or vegetable products, as well as in the manufacture of alcoholic beverages from fruits other than grapes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.274 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 833 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 3,040. A search was made for the similarity of the amino acid sequence of the food enzyme to those of known allergens and three matches with respiratory allergens were found. The Panel considered that under the intended conditions of use, the risk of allergic reactions by dietary exposure, particularly in individuals sensitised to olive pollen, although unlikely, cannot be excluded. The Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
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spelling pubmed-97286162022-12-08 Safety evaluation of the food enzyme pectinesterase from the genetically modified Aspergillus luchuensis strain FLZSC 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 Glandorf, Boet Roos, Yrjö Andryszkiewicz, Magdalena Kovalkovicova, Natalia Liu, Yi Lunardi, Simone de Sousa, Rita Ferreira Chesson, Andrew EFSA J Scientific Opinion The food enzyme pectinesterase (pectin pectylhydrolase, EC 3.1.1.11) is produced with the genetically modified Aspergillus luchuensis strain FLZSC by Advanced Enzyme Technologies Ltd. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in fruit and vegetable processing for the production of juices and other fruit or vegetable products, as well as in the manufacture of alcoholic beverages from fruits other than grapes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.274 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 833 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 3,040. A search was made for the similarity of the amino acid sequence of the food enzyme to those of known allergens and three matches with respiratory allergens were found. The Panel considered that under the intended conditions of use, the risk of allergic reactions by dietary exposure, particularly in individuals sensitised to olive pollen, although unlikely, cannot be excluded. 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. 2022-12-07 /pmc/articles/PMC9728616/ /pubmed/36507099 http://dx.doi.org/10.2903/j.efsa.2022.7674 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
Glandorf, Boet
Roos, Yrjö
Andryszkiewicz, Magdalena
Kovalkovicova, Natalia
Liu, Yi
Lunardi, Simone
de Sousa, Rita Ferreira
Chesson, Andrew
Safety evaluation of the food enzyme pectinesterase from the genetically modified Aspergillus luchuensis strain FLZSC
title Safety evaluation of the food enzyme pectinesterase from the genetically modified Aspergillus luchuensis strain FLZSC
title_full Safety evaluation of the food enzyme pectinesterase from the genetically modified Aspergillus luchuensis strain FLZSC
title_fullStr Safety evaluation of the food enzyme pectinesterase from the genetically modified Aspergillus luchuensis strain FLZSC
title_full_unstemmed Safety evaluation of the food enzyme pectinesterase from the genetically modified Aspergillus luchuensis strain FLZSC
title_short Safety evaluation of the food enzyme pectinesterase from the genetically modified Aspergillus luchuensis strain FLZSC
title_sort safety evaluation of the food enzyme pectinesterase from the genetically modified aspergillus luchuensis strain flzsc
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9728616/
https://www.ncbi.nlm.nih.gov/pubmed/36507099
http://dx.doi.org/10.2903/j.efsa.2022.7674
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