Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Trichoderma reesei strain DP‐Nzk98
Abstract The food enzyme phospholipase A1 (phosphatidylcholine 1‐acylhydrolase; EC 3.1.1.32) is produced with the genetically modified Trichoderma reesei strain DP‐Nzk98 by Genencor International B.V. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable...
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| Format: | Article |
| Language: | English |
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Wiley
2025-05-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2025.9425 |
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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 Magdalena Andryszkiewicz Daniele Cavanna Natália Kovalkovičová 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 Magdalena Andryszkiewicz Daniele Cavanna Natália Kovalkovičová Yi Liu |
| author_sort | EFSA Panel on Food Enzymes (FEZ) |
| collection | DOAJ |
| description | Abstract The food enzyme phospholipase A1 (phosphatidylcholine 1‐acylhydrolase; EC 3.1.1.32) is produced with the genetically modified Trichoderma reesei strain DP‐Nzk98 by Genencor International B.V. 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. The food enzyme is intended to be used in the processing of cereals and other grains for the production of baked products. Dietary exposure was estimated to be up to 0.972 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1029. A search for the homology of the amino acid sequence of the phospholipase A1 to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that 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. |
| format | Article |
| id | doaj-art-a63ebed1fbeb4b8fb4db604aeda8d223 |
| institution | OA Journals |
| issn | 1831-4732 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-a63ebed1fbeb4b8fb4db604aeda8d2232025-08-20T02:37:38ZengWileyEFSA Journal1831-47322025-05-01235n/an/a10.2903/j.efsa.2025.9425Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Trichoderma reesei strain DP‐Nzk98EFSA Panel on Food Enzymes (FEZ)Holger ZornJosé Manuel Barat BavieraClaudia BolognesiFrancesco CataniaGabriele GadermaierRalf GreinerBaltasar MayoAlicja MortensenYrjö Henrik RoosMarize L. M. SolanoMonika SramkovaHenk Van LoverenLaurence VernisMagdalena AndryszkiewiczDaniele CavannaNatália KovalkovičováYi LiuAbstract The food enzyme phospholipase A1 (phosphatidylcholine 1‐acylhydrolase; EC 3.1.1.32) is produced with the genetically modified Trichoderma reesei strain DP‐Nzk98 by Genencor International B.V. 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. The food enzyme is intended to be used in the processing of cereals and other grains for the production of baked products. Dietary exposure was estimated to be up to 0.972 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1029. A search for the homology of the amino acid sequence of the phospholipase A1 to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that 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.2025.9425EC 3.1.1.32EFSA‐Q‐2024‐00065food enzymegenetically modified microorganismphosphatidylcholine 1‐acylhydrolasephospholipase A1 |
| 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 Magdalena Andryszkiewicz Daniele Cavanna Natália Kovalkovičová Yi Liu Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Trichoderma reesei strain DP‐Nzk98 EFSA Journal EC 3.1.1.32 EFSA‐Q‐2024‐00065 food enzyme genetically modified microorganism phosphatidylcholine 1‐acylhydrolase phospholipase A1 |
| title | Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Trichoderma reesei strain DP‐Nzk98 |
| title_full | Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Trichoderma reesei strain DP‐Nzk98 |
| title_fullStr | Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Trichoderma reesei strain DP‐Nzk98 |
| title_full_unstemmed | Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Trichoderma reesei strain DP‐Nzk98 |
| title_short | Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Trichoderma reesei strain DP‐Nzk98 |
| title_sort | safety evaluation of the food enzyme phospholipase a1 from the genetically modified trichoderma reesei strain dp nzk98 |
| topic | EC 3.1.1.32 EFSA‐Q‐2024‐00065 food enzyme genetically modified microorganism phosphatidylcholine 1‐acylhydrolase phospholipase A1 |
| url | https://doi.org/10.2903/j.efsa.2025.9425 |
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