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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2024-12-01
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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. |
format | Article |
id | doaj-art-bb944688ee08455f92fc40ab1fe96388 |
institution | Kabale University |
issn | 1831-4732 |
language | English |
publishDate | 2024-12-01 |
publisher | Wiley |
record_format | Article |
series | EFSA Journal |
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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