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Safety evaluation of the food enzyme β‐galactosidase from the genetically modified Kluyveromyces lactis strain KLA

The food enzyme β‐galactosidase (β‐d‐galactoside galactohydrolase; EC 3.2.1.23) is produced with the genetically modified Kluyveromyces lactis strain KLA by DSM Food Specialties B.V. The genetic modifications did 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, Aguilera, Jaime, Andryszkiewicz, Magdalena, Cavanna, Daniele, Ferreira de Sousa, Rita, Liu, Yi, di Piazza, Giulio, 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/PMC9557809/
https://www.ncbi.nlm.nih.gov/pubmed/36254192
http://dx.doi.org/10.2903/j.efsa.2022.7575
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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
Aguilera, Jaime
Andryszkiewicz, Magdalena
Cavanna, Daniele
Ferreira de Sousa, Rita
Liu, Yi
di Piazza, Giulio
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
Aguilera, Jaime
Andryszkiewicz, Magdalena
Cavanna, Daniele
Ferreira de Sousa, Rita
Liu, Yi
di Piazza, Giulio
Chesson, Andrew
collection PubMed
description The food enzyme β‐galactosidase (β‐d‐galactoside galactohydrolase; EC 3.2.1.23) is produced with the genetically modified Kluyveromyces lactis strain KLA by DSM Food Specialties B.V. The genetic modifications did not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used for the lactose hydrolysis in milk processing, production of fermented milk products and whey processing. It is also intended for lactose hydrolysis in milk products at home. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 11.876 mg TOS/kg body weight per day in European populations. The production strain of the food enzyme fulfils the requirements for the Qualified Presumption of Safety (QPS) approach to safety assessment. As no concerns arising from its genetic modification or from the manufacturing process have been identified, the Panel considered that toxicological tests are not needed for the assessment of this food enzyme. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is low. 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-95578092022-10-16 Safety evaluation of the food enzyme β‐galactosidase from the genetically modified Kluyveromyces lactis strain KLA 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 Aguilera, Jaime Andryszkiewicz, Magdalena Cavanna, Daniele Ferreira de Sousa, Rita Liu, Yi di Piazza, Giulio Chesson, Andrew EFSA J Scientific Opinion The food enzyme β‐galactosidase (β‐d‐galactoside galactohydrolase; EC 3.2.1.23) is produced with the genetically modified Kluyveromyces lactis strain KLA by DSM Food Specialties B.V. The genetic modifications did not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used for the lactose hydrolysis in milk processing, production of fermented milk products and whey processing. It is also intended for lactose hydrolysis in milk products at home. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 11.876 mg TOS/kg body weight per day in European populations. The production strain of the food enzyme fulfils the requirements for the Qualified Presumption of Safety (QPS) approach to safety assessment. As no concerns arising from its genetic modification or from the manufacturing process have been identified, the Panel considered that toxicological tests are not needed for the assessment of this food enzyme. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is low. 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. 2022-10-13 /pmc/articles/PMC9557809/ /pubmed/36254192 http://dx.doi.org/10.2903/j.efsa.2022.7575 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
Aguilera, Jaime
Andryszkiewicz, Magdalena
Cavanna, Daniele
Ferreira de Sousa, Rita
Liu, Yi
di Piazza, Giulio
Chesson, Andrew
Safety evaluation of the food enzyme β‐galactosidase from the genetically modified Kluyveromyces lactis strain KLA
title Safety evaluation of the food enzyme β‐galactosidase from the genetically modified Kluyveromyces lactis strain KLA
title_full Safety evaluation of the food enzyme β‐galactosidase from the genetically modified Kluyveromyces lactis strain KLA
title_fullStr Safety evaluation of the food enzyme β‐galactosidase from the genetically modified Kluyveromyces lactis strain KLA
title_full_unstemmed Safety evaluation of the food enzyme β‐galactosidase from the genetically modified Kluyveromyces lactis strain KLA
title_short Safety evaluation of the food enzyme β‐galactosidase from the genetically modified Kluyveromyces lactis strain KLA
title_sort safety evaluation of the food enzyme β‐galactosidase from the genetically modified kluyveromyces lactis strain kla
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9557809/
https://www.ncbi.nlm.nih.gov/pubmed/36254192
http://dx.doi.org/10.2903/j.efsa.2022.7575
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