Revised dietary exposure assessment of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus oryzae strain NZYM‐AL

Abstract The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the genetically modified Aspergillus oryzae strain NZYM‐AL by Novozymes A/S. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that, under the intended cond...

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Main Authors: EFSA Panel on Food Enzymes (FEZ), Holger Zorn, José Manuel Barat Baviera, Claudia Bolognesi, Francesco Catania, Gabriele Gadermaier, Ralf Greiner, Baltasar Mayo, Alicja Mortensen, Yrjö Henrik Roos, Marize L. M. Solano, Monika Sramkova, Henk Van Loveren, Laurence Vernis, Daniele Cavanna, Yi Liu
Format: Article
Language:English
Published: Wiley 2024-12-01
Series:EFSA Journal
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Online Access:https://doi.org/10.2903/j.efsa.2024.9166
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author EFSA Panel on Food Enzymes (FEZ)
Holger Zorn
José Manuel Barat Baviera
Claudia Bolognesi
Francesco Catania
Gabriele Gadermaier
Ralf Greiner
Baltasar Mayo
Alicja Mortensen
Yrjö Henrik Roos
Marize L. M. Solano
Monika Sramkova
Henk Van Loveren
Laurence Vernis
Daniele Cavanna
Yi Liu
author_facet EFSA Panel on Food Enzymes (FEZ)
Holger Zorn
José Manuel Barat Baviera
Claudia Bolognesi
Francesco Catania
Gabriele Gadermaier
Ralf Greiner
Baltasar Mayo
Alicja Mortensen
Yrjö Henrik Roos
Marize L. M. Solano
Monika Sramkova
Henk Van Loveren
Laurence Vernis
Daniele Cavanna
Yi Liu
author_sort EFSA Panel on Food Enzymes (FEZ)
collection DOAJ
description Abstract The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the genetically modified Aspergillus oryzae strain NZYM‐AL by Novozymes A/S. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that, under the intended conditions of use, this food enzyme did not give rise to safety concerns. Due to the implementation of a new methodology to estimate the dietary exposure to food enzymes in 2016, the European Commission requested EFSA to revise the exposure assessment of this food enzyme by using this new methodology. In this assessment, EFSA realigned the intended uses of this food enzyme to four food manufacturing processes. The dietary exposure was calculated to be up to 0.089 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (49.1 mg TOS/kg bw per day, the lowest dose tested), the Panel derived a margin of exposure of at least 552. Based on the revised exposure estimate, the margin of exposure calculated thereof and the previous evaluation, 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-bb944688ee08455f92fc40ab1fe963882025-01-17T06:31:16ZengWileyEFSA Journal1831-47322024-12-012212n/an/a10.2903/j.efsa.2024.9166Revised dietary exposure assessment of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus oryzae strain NZYM‐ALEFSA Panel on Food Enzymes (FEZ)Holger ZornJosé Manuel Barat BavieraClaudia BolognesiFrancesco CataniaGabriele GadermaierRalf GreinerBaltasar MayoAlicja MortensenYrjö Henrik RoosMarize L. M. SolanoMonika SramkovaHenk Van LoverenLaurence VernisDaniele CavannaYi LiuAbstract The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the genetically modified Aspergillus oryzae strain NZYM‐AL by Novozymes A/S. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that, under the intended conditions of use, this food enzyme did not give rise to safety concerns. Due to the implementation of a new methodology to estimate the dietary exposure to food enzymes in 2016, the European Commission requested EFSA to revise the exposure assessment of this food enzyme by using this new methodology. In this assessment, EFSA realigned the intended uses of this food enzyme to four food manufacturing processes. The dietary exposure was calculated to be up to 0.089 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (49.1 mg TOS/kg bw per day, the lowest dose tested), the Panel derived a margin of exposure of at least 552. Based on the revised exposure estimate, the margin of exposure calculated thereof and the previous evaluation, 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.2024.9166Aspergillus oryzaeEC 3.1.1.3EFSA‐Q‐2013‐00198EFSA‐Q‐2024‐00610food enzymegenetically modified microorganism
spellingShingle EFSA Panel on Food Enzymes (FEZ)
Holger Zorn
José Manuel Barat Baviera
Claudia Bolognesi
Francesco Catania
Gabriele Gadermaier
Ralf Greiner
Baltasar Mayo
Alicja Mortensen
Yrjö Henrik Roos
Marize L. M. Solano
Monika Sramkova
Henk Van Loveren
Laurence Vernis
Daniele Cavanna
Yi Liu
Revised dietary exposure assessment of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus oryzae strain NZYM‐AL
EFSA Journal
Aspergillus oryzae
EC 3.1.1.3
EFSA‐Q‐2013‐00198
EFSA‐Q‐2024‐00610
food enzyme
genetically modified microorganism
title Revised dietary exposure assessment of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus oryzae strain NZYM‐AL
title_full Revised dietary exposure assessment of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus oryzae strain NZYM‐AL
title_fullStr Revised dietary exposure assessment of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus oryzae strain NZYM‐AL
title_full_unstemmed Revised dietary exposure assessment of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus oryzae strain NZYM‐AL
title_short Revised dietary exposure assessment of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus oryzae strain NZYM‐AL
title_sort revised dietary exposure assessment of the food enzyme triacylglycerol lipase from the genetically modified aspergillus oryzae strain nzym al
topic Aspergillus oryzae
EC 3.1.1.3
EFSA‐Q‐2013‐00198
EFSA‐Q‐2024‐00610
food enzyme
genetically modified microorganism
url https://doi.org/10.2903/j.efsa.2024.9166
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