Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Aspergillus niger strain NZYM‐FP

The food enzyme phospholipase A1 (phosphatidycholine 1‐acylhydrolase EC 3.1.1.32) is produced with the genetically modified Aspergillus niger strain NZYM‐FP by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production or...

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Autores principales: Silano, Vittorio, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lambré, Claude, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Andryszkiewicz, Magdalena, Kovalkovicova, Natalia, Liu, Yi, Rainieri, Sandra, Chesson, Andrew
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10464675/
https://www.ncbi.nlm.nih.gov/pubmed/37649493
http://dx.doi.org/10.2903/j.efsa.2020.6131
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author Silano, Vittorio
Barat Baviera, José Manuel
Bolognesi, Claudia
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David Michael
Grob, Konrad
Lambré, Claude
Lampi, Evgenia
Mengelers, Marcel
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger‐Lise
Tlustos, Christina
Van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Andryszkiewicz, Magdalena
Kovalkovicova, Natalia
Liu, Yi
Rainieri, Sandra
Chesson, Andrew
author_facet Silano, Vittorio
Barat Baviera, José Manuel
Bolognesi, Claudia
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David Michael
Grob, Konrad
Lambré, Claude
Lampi, Evgenia
Mengelers, Marcel
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger‐Lise
Tlustos, Christina
Van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Andryszkiewicz, Magdalena
Kovalkovicova, Natalia
Liu, Yi
Rainieri, Sandra
Chesson, Andrew
collection PubMed
description The food enzyme phospholipase A1 (phosphatidycholine 1‐acylhydrolase EC 3.1.1.32) is produced with the genetically modified Aspergillus niger strain NZYM‐FP by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The phospholipase A1 food enzyme is intended to be used for degumming of fats and oils. Since residual amounts of Total Organic Solids (TOS) are removed by the purification steps applied during degumming, dietary exposure estimation was not considered necessary. Genotoxicity tests did not raise safety concerns. The repeated dose 90‐day oral 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 (NOAEL) of 1,356 mg TOS/kg body weight (bw) per day, the highest dose tested. 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 upon dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. Based on the data provided and the removal of TOS during the degumming of fats and oils, 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-104646752023-08-30 Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Aspergillus niger strain NZYM‐FP Silano, Vittorio Barat Baviera, José Manuel Bolognesi, Claudia Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lambré, Claude Lampi, Evgenia Mengelers, Marcel Mortensen, Alicja Rivière, Gilles Steffensen, Inger‐Lise Tlustos, Christina Van Loveren, Henk Vernis, Laurence Zorn, Holger Andryszkiewicz, Magdalena Kovalkovicova, Natalia Liu, Yi Rainieri, Sandra Chesson, Andrew EFSA J Scientific Opinion The food enzyme phospholipase A1 (phosphatidycholine 1‐acylhydrolase EC 3.1.1.32) is produced with the genetically modified Aspergillus niger strain NZYM‐FP by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The phospholipase A1 food enzyme is intended to be used for degumming of fats and oils. Since residual amounts of Total Organic Solids (TOS) are removed by the purification steps applied during degumming, dietary exposure estimation was not considered necessary. Genotoxicity tests did not raise safety concerns. The repeated dose 90‐day oral 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 (NOAEL) of 1,356 mg TOS/kg body weight (bw) per day, the highest dose tested. 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 upon dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. Based on the data provided and the removal of TOS during the degumming of fats and oils, 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. 2020-05-20 /pmc/articles/PMC10464675/ /pubmed/37649493 http://dx.doi.org/10.2903/j.efsa.2020.6131 Text en © 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of 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
Silano, Vittorio
Barat Baviera, José Manuel
Bolognesi, Claudia
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David Michael
Grob, Konrad
Lambré, Claude
Lampi, Evgenia
Mengelers, Marcel
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger‐Lise
Tlustos, Christina
Van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Andryszkiewicz, Magdalena
Kovalkovicova, Natalia
Liu, Yi
Rainieri, Sandra
Chesson, Andrew
Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Aspergillus niger strain NZYM‐FP
title Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Aspergillus niger strain NZYM‐FP
title_full Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Aspergillus niger strain NZYM‐FP
title_fullStr Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Aspergillus niger strain NZYM‐FP
title_full_unstemmed Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Aspergillus niger strain NZYM‐FP
title_short Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Aspergillus niger strain NZYM‐FP
title_sort safety evaluation of the food enzyme phospholipase a1 from the genetically modified aspergillus niger strain nzym‐fp
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10464675/
https://www.ncbi.nlm.nih.gov/pubmed/37649493
http://dx.doi.org/10.2903/j.efsa.2020.6131
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