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Safety evaluation of the food enzyme xylose isomerase from the genetically modified Streptomyces rubiginosus strain DP‐Pzn37

The food enzyme is a d‐xylose aldose‐ketose‐isomerase (EC 5.3.1.5) produced with the genetically modified Streptomyces rubiginosus strain DP‐Pzn37 by Danisco US Inc. Although the production strain contains antibiotic resistance genes, the food enzyme was shown to be free from viable cells of the pro...

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Autores principales: Silano, Vittorio, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Glandorf, Boet, Herman, Lieve, Engel, Karl‐Heinz, Smith, Andrew, Želježić, Davor, Aguilera‐Gómez, Margarita, Gomes, Ana, Kovalkovičová, Natália, Liu, Yi, Maia, Joaquim, 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/PMC7008836/
https://www.ncbi.nlm.nih.gov/pubmed/32626507
http://dx.doi.org/10.2903/j.efsa.2020.5978
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author Silano, Vittorio
Barat Baviera, José Manuel
Bolognesi, Claudia
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David Michael
Grob, Konrad
Lampi, Evgenia
Mortensen, Alicja
Rivière, Gilles
Steffensen, Inger‐Lise
Tlustos, Christina
van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Glandorf, Boet
Herman, Lieve
Engel, Karl‐Heinz
Smith, Andrew
Želježić, Davor
Aguilera‐Gómez, Margarita
Gomes, Ana
Kovalkovičová, Natália
Liu, Yi
Maia, Joaquim
Rainieri, Sandra
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
Rivière, Gilles
Steffensen, Inger‐Lise
Tlustos, Christina
van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Glandorf, Boet
Herman, Lieve
Engel, Karl‐Heinz
Smith, Andrew
Želježić, Davor
Aguilera‐Gómez, Margarita
Gomes, Ana
Kovalkovičová, Natália
Liu, Yi
Maia, Joaquim
Rainieri, Sandra
Chesson, Andrew
collection PubMed
description The food enzyme is a d‐xylose aldose‐ketose‐isomerase (EC 5.3.1.5) produced with the genetically modified Streptomyces rubiginosus strain DP‐Pzn37 by Danisco US Inc. Although the production strain contains antibiotic resistance genes, the food enzyme was shown to be free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in an immobilised form for the isomerisation of glucose for the production of high fructose syrups. Residual amounts of total organic solids (TOS) are eliminated by the use of an immobilised food enzyme and further removed by the purification steps applied during the production of high fructose syrups using the immobilised enzyme; consequently, dietary exposure was not calculated. Genotoxicity tests did not raise safety concerns. 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 85.2 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 by dietary exposure cannot be excluded, but the likelihood is considered to be low. Based on the data provided, the immobilisation process and the removal of total organic solids during the production of high fructose syrups, 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-70088362020-07-02 Safety evaluation of the food enzyme xylose isomerase from the genetically modified Streptomyces rubiginosus strain DP‐Pzn37 Silano, Vittorio Barat Baviera, José Manuel Bolognesi, Claudia Cocconcelli, Pier Sandro Crebelli, Riccardo Gott, David Michael Grob, Konrad Lampi, Evgenia Mortensen, Alicja Rivière, Gilles Steffensen, Inger‐Lise Tlustos, Christina van Loveren, Henk Vernis, Laurence Zorn, Holger Glandorf, Boet Herman, Lieve Engel, Karl‐Heinz Smith, Andrew Želježić, Davor Aguilera‐Gómez, Margarita Gomes, Ana Kovalkovičová, Natália Liu, Yi Maia, Joaquim Rainieri, Sandra Chesson, Andrew EFSA J Scientific Opinion The food enzyme is a d‐xylose aldose‐ketose‐isomerase (EC 5.3.1.5) produced with the genetically modified Streptomyces rubiginosus strain DP‐Pzn37 by Danisco US Inc. Although the production strain contains antibiotic resistance genes, the food enzyme was shown to be free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in an immobilised form for the isomerisation of glucose for the production of high fructose syrups. Residual amounts of total organic solids (TOS) are eliminated by the use of an immobilised food enzyme and further removed by the purification steps applied during the production of high fructose syrups using the immobilised enzyme; consequently, dietary exposure was not calculated. Genotoxicity tests did not raise safety concerns. 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 85.2 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 by dietary exposure cannot be excluded, but the likelihood is considered to be low. Based on the data provided, the immobilisation process and the removal of total organic solids during the production of high fructose syrups, 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. 2020-01-20 /pmc/articles/PMC7008836/ /pubmed/32626507 http://dx.doi.org/10.2903/j.efsa.2020.5978 Text en © 2020 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
Rivière, Gilles
Steffensen, Inger‐Lise
Tlustos, Christina
van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Glandorf, Boet
Herman, Lieve
Engel, Karl‐Heinz
Smith, Andrew
Želježić, Davor
Aguilera‐Gómez, Margarita
Gomes, Ana
Kovalkovičová, Natália
Liu, Yi
Maia, Joaquim
Rainieri, Sandra
Chesson, Andrew
Safety evaluation of the food enzyme xylose isomerase from the genetically modified Streptomyces rubiginosus strain DP‐Pzn37
title Safety evaluation of the food enzyme xylose isomerase from the genetically modified Streptomyces rubiginosus strain DP‐Pzn37
title_full Safety evaluation of the food enzyme xylose isomerase from the genetically modified Streptomyces rubiginosus strain DP‐Pzn37
title_fullStr Safety evaluation of the food enzyme xylose isomerase from the genetically modified Streptomyces rubiginosus strain DP‐Pzn37
title_full_unstemmed Safety evaluation of the food enzyme xylose isomerase from the genetically modified Streptomyces rubiginosus strain DP‐Pzn37
title_short Safety evaluation of the food enzyme xylose isomerase from the genetically modified Streptomyces rubiginosus strain DP‐Pzn37
title_sort safety evaluation of the food enzyme xylose isomerase from the genetically modified streptomyces rubiginosus strain dp‐pzn37
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7008836/
https://www.ncbi.nlm.nih.gov/pubmed/32626507
http://dx.doi.org/10.2903/j.efsa.2020.5978
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