Safety evaluation of an extension of use of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus niger strain LFS

Abstract The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the genetically modified Aspergillus niger strain LFS by DSM Food Specialties B.V. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme d...

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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 2025-01-01
Series:EFSA Journal
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Online Access:https://doi.org/10.2903/j.efsa.2025.9225
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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 niger strain LFS by DSM Food Specialties B.V. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in one food manufacturing process. Subsequently, the applicant has requested to extend its use to include one additional process. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of two food manufacturing processes. The dietary exposure was calculated to be up to 0.110 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1038 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 9436. Based on the new data, the revised margin of exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.
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issn 1831-4732
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spelling doaj-art-96d8e6334de64077844871402174a8222025-01-31T12:06:04ZengWileyEFSA Journal1831-47322025-01-01231n/an/a10.2903/j.efsa.2025.9225Safety evaluation of an extension of use of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus niger strain LFSEFSA 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 niger strain LFS by DSM Food Specialties B.V. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in one food manufacturing process. Subsequently, the applicant has requested to extend its use to include one additional process. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of two food manufacturing processes. The dietary exposure was calculated to be up to 0.110 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1038 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 9436. Based on the new data, the revised margin of exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.https://doi.org/10.2903/j.efsa.2025.9225EFSA‐Q‐2014‐00325EFSA‐Q‐2024‐00295Aspergillus nigerEC 3.1.1.3food 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
Safety evaluation of an extension of use of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus niger strain LFS
EFSA Journal
EFSA‐Q‐2014‐00325
EFSA‐Q‐2024‐00295
Aspergillus niger
EC 3.1.1.3
food enzyme
genetically modified microorganism
title Safety evaluation of an extension of use of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus niger strain LFS
title_full Safety evaluation of an extension of use of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus niger strain LFS
title_fullStr Safety evaluation of an extension of use of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus niger strain LFS
title_full_unstemmed Safety evaluation of an extension of use of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus niger strain LFS
title_short Safety evaluation of an extension of use of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus niger strain LFS
title_sort safety evaluation of an extension of use of the food enzyme triacylglycerol lipase from the genetically modified aspergillus niger strain lfs
topic EFSA‐Q‐2014‐00325
EFSA‐Q‐2024‐00295
Aspergillus niger
EC 3.1.1.3
food enzyme
genetically modified microorganism
url https://doi.org/10.2903/j.efsa.2025.9225
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