Safety evaluation of an extension of use of the food enzyme lysophospholipase from the genetically modified Aspergillus niger strain NZYM‐LP
Abstract
The food enzyme lysophospholipase (2-lysophosphatidylcholine acylhydrolase, EC 3.1.1.5) is produced with the genetically modified Aspergillus niger strain NZYM-LP by Novozymes A/S. The safety of this food enzyme was evaluated previously, and it did not give rise to safety concerns when used in two food manufacturing processes. Subsequently, the applicant has requested to extend its use to include two additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of four food manufacturing processes. As the food enzyme-Total Organic Solids (TOS) are removed in three processes, the dietary exposure to the food enzyme-TOS was estimated for the remaining food manufacturing process. Dietary exposure was calculated to be up to 0.062 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1356 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 21,871. Based on the revised exposure estimation, the newly derived 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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BibTeX
@article{fez2026safety,
title = {{Safety evaluation of an extension of use of the food enzyme lysophospholipase from the genetically modified Aspergillus niger strain NZYM‐LP}},
author = {EFSA Panel on Food Enzymes (FEZ) and Holger Zorn and José Manuel Barat Baviera and Claudia Bolognesi and Francesco Catania and Gabriele Gadermaier and Ralf Greiner and Baltasar Mayo and Alicja Mortensen and Yrjö Henrik Roos and Marize L M Solano and Henk Van Loveren and Laurence Vernis and Daniele Cavanna and Yi Liu and Anna Ferrandis Rosell},
journal = {EFSA journal. European Food Safety Authority},
year = {2026},
month = oct,
doi = {10.2903/j.efsa.2026.10400},
url = {https://europepmc.org/article/PMC/PMC13717483},
note = {CC BY-ND},
}
RIS
TY - JOUR
TI - Safety evaluation of an extension of use of the food enzyme lysophospholipase from the genetically modified Aspergillus niger strain NZYM‐LP
AU - EFSA Panel on Food Enzymes (FEZ)
AU - Holger Zorn
AU - José Manuel Barat Baviera
AU - Claudia Bolognesi
AU - Francesco Catania
AU - Gabriele Gadermaier
AU - Ralf Greiner
AU - Baltasar Mayo
AU - Alicja Mortensen
AU - Yrjö Henrik Roos
AU - Marize L M Solano
AU - Henk Van Loveren
AU - Laurence Vernis
AU - Daniele Cavanna
AU - Yi Liu
AU - Anna Ferrandis Rosell
PY - 2026
DA - 2026/10/01
JO - EFSA journal. European Food Safety Authority
DO - 10.2903/j.efsa.2026.10400
UR - https://europepmc.org/article/PMC/PMC13717483
AB - The food enzyme lysophospholipase (2-lysophosphatidylcholine acylhydrolase, EC 3.1.1.5) is produced with the genetically modified Aspergillus niger strain NZYM-LP by Novozymes A/S. The safety of this food enzyme was evaluated previously, and it did not give rise to safety concerns when used in two food manufacturing processes. Subsequently, the applicant has requested to extend its use to include two additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of four food manufacturing processes. As the food enzyme-Total Organic Solids (TOS) are removed in three processes, the dietary exposure to the food enzyme-TOS was estimated for the remaining food manufacturing process. Dietary exposure was calculated to be up to 0.062 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1356 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 21,871. Based on the revised exposure estimation, the newly derived 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.
SN - 1831-4732
ER -