Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus luchuensis strain FL108SC

Abstract The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the genetically modified Aspergillus luchuensis strain FL108SC by Advanced Enzyme Technologies Ltd. The genetic modifications do not give rise to safety concerns. The food enzyme is free from...

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Main Authors: EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Claude Lambré, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Lieve Herman, Yrjö Roos, Magdalena Andryszkiewicz, Ana Gomes, Natalia Kovalkovicova, Yi Liu, Andrew Chesson
Format: Article
Language:English
Published: Wiley 2023-10-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2023.8260
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author EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
Claude Lambré
José Manuel Barat Baviera
Claudia Bolognesi
Pier Sandro Cocconcelli
Riccardo Crebelli
David Michael Gott
Konrad Grob
Evgenia Lampi
Marcel Mengelers
Alicja Mortensen
Gilles Rivière
Inger‐Lise Steffensen
Christina Tlustos
Henk Van Loveren
Laurence Vernis
Holger Zorn
Lieve Herman
Yrjö Roos
Magdalena Andryszkiewicz
Ana Gomes
Natalia Kovalkovicova
Yi Liu
Andrew Chesson
author_facet EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
Claude Lambré
José Manuel Barat Baviera
Claudia Bolognesi
Pier Sandro Cocconcelli
Riccardo Crebelli
David Michael Gott
Konrad Grob
Evgenia Lampi
Marcel Mengelers
Alicja Mortensen
Gilles Rivière
Inger‐Lise Steffensen
Christina Tlustos
Henk Van Loveren
Laurence Vernis
Holger Zorn
Lieve Herman
Yrjö Roos
Magdalena Andryszkiewicz
Ana Gomes
Natalia Kovalkovicova
Yi Liu
Andrew Chesson
author_sort EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
collection DOAJ
description Abstract The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the genetically modified Aspergillus luchuensis strain FL108SC by Advanced Enzyme Technologies Ltd. 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. It is intended to be used in an immobilised form for the production of modified fats and oils by interesterification. Genotoxicity tests did not raise safety concerns. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rodents. The Panel identified a no observed adverse effect level (NOAEL) at the highest dose of 774 mg TOS/kg body weight per day. As the food enzyme is used in an immobilised form and as any residual amounts of the food enzyme‐total organic solids (TOS) are removed during the food manufacturing process, dietary exposure was not calculated. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure cannot be excluded, but the likelihood is low. 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.
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spelling doaj.art-85cafa74e6284636a656d90566fb67912023-11-06T09:10:56ZengWileyEFSA Journal1831-47322023-10-012110n/an/a10.2903/j.efsa.2023.8260Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus luchuensis strain FL108SCEFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)Claude LambréJosé Manuel Barat BavieraClaudia BolognesiPier Sandro CocconcelliRiccardo CrebelliDavid Michael GottKonrad GrobEvgenia LampiMarcel MengelersAlicja MortensenGilles RivièreInger‐Lise SteffensenChristina TlustosHenk Van LoverenLaurence VernisHolger ZornLieve HermanYrjö RoosMagdalena AndryszkiewiczAna GomesNatalia KovalkovicovaYi LiuAndrew ChessonAbstract The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the genetically modified Aspergillus luchuensis strain FL108SC by Advanced Enzyme Technologies Ltd. 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. It is intended to be used in an immobilised form for the production of modified fats and oils by interesterification. Genotoxicity tests did not raise safety concerns. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rodents. The Panel identified a no observed adverse effect level (NOAEL) at the highest dose of 774 mg TOS/kg body weight per day. As the food enzyme is used in an immobilised form and as any residual amounts of the food enzyme‐total organic solids (TOS) are removed during the food manufacturing process, dietary exposure was not calculated. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure cannot be excluded, but the likelihood is low. 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.https://doi.org/10.2903/j.efsa.2023.8260food enzymetriacylglycerol lipasetriacylglycerol acylhydrolaseEC 3.1.1.3lipaseAspergillus luchuensis
spellingShingle EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
Claude Lambré
José Manuel Barat Baviera
Claudia Bolognesi
Pier Sandro Cocconcelli
Riccardo Crebelli
David Michael Gott
Konrad Grob
Evgenia Lampi
Marcel Mengelers
Alicja Mortensen
Gilles Rivière
Inger‐Lise Steffensen
Christina Tlustos
Henk Van Loveren
Laurence Vernis
Holger Zorn
Lieve Herman
Yrjö Roos
Magdalena Andryszkiewicz
Ana Gomes
Natalia Kovalkovicova
Yi Liu
Andrew Chesson
Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus luchuensis strain FL108SC
EFSA Journal
food enzyme
triacylglycerol lipase
triacylglycerol acylhydrolase
EC 3.1.1.3
lipase
Aspergillus luchuensis
title Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus luchuensis strain FL108SC
title_full Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus luchuensis strain FL108SC
title_fullStr Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus luchuensis strain FL108SC
title_full_unstemmed Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus luchuensis strain FL108SC
title_short Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus luchuensis strain FL108SC
title_sort safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified aspergillus luchuensis strain fl108sc
topic food enzyme
triacylglycerol lipase
triacylglycerol acylhydrolase
EC 3.1.1.3
lipase
Aspergillus luchuensis
url https://doi.org/10.2903/j.efsa.2023.8260
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