Safety evaluation of the food enzyme fructan β‐fructosidase from the genetically modified Trichoderma reesei strain AR‐577
Abstract The food enzyme fructan β‐fructosidase (β‐d‐fructan fructohydrolase; EC 3.2.1.80) is produced with the genetically modified Trichoderma reesei strain AR‐577 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the pr...
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| Language: | English |
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Wiley
2024-12-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2024.9124 |
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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 Andrew Chesson Lieve Herman Natália Kovalkovičová Jaime Aguilera Magdalena Andryszkiewicz 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 Andrew Chesson Lieve Herman Natália Kovalkovičová Jaime Aguilera Magdalena Andryszkiewicz Daniele Cavanna Yi Liu |
| author_sort | EFSA Panel on Food Enzymes (FEZ) |
| collection | DOAJ |
| description | Abstract The food enzyme fructan β‐fructosidase (β‐d‐fructan fructohydrolase; EC 3.2.1.80) is produced with the genetically modified Trichoderma reesei strain AR‐577 by AB Enzymes GmbH. 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 and cereal‐based products other than baked. Dietary exposure was estimated to be up to 0.181 mg total organic solids (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 5495. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and no match was found. A known source of food allergens was used in the food enzyme manufacturing process. The Panel considered that the risk of allergic reactions upon dietary exposure cannot be excluded but 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-207bfd5af9d34f25be323e34edbfa56d |
| institution | Kabale University |
| issn | 1831-4732 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-207bfd5af9d34f25be323e34edbfa56d2025-01-17T06:31:16ZengWileyEFSA Journal1831-47322024-12-012212n/an/a10.2903/j.efsa.2024.9124Safety evaluation of the food enzyme fructan β‐fructosidase from the genetically modified Trichoderma reesei strain AR‐577EFSA Panel on Food Enzymes (FEZ)Holger ZornJosé Manuel Barat BavieraClaudia BolognesiFrancesco CataniaGabriele GadermaierRalf GreinerBaltasar MayoAlicja MortensenYrjö Henrik RoosMarize L. M. SolanoMonika SramkovaHenk Van LoverenLaurence VernisAndrew ChessonLieve HermanNatália KovalkovičováJaime AguileraMagdalena AndryszkiewiczDaniele CavannaYi LiuAbstract The food enzyme fructan β‐fructosidase (β‐d‐fructan fructohydrolase; EC 3.2.1.80) is produced with the genetically modified Trichoderma reesei strain AR‐577 by AB Enzymes GmbH. 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 and cereal‐based products other than baked. Dietary exposure was estimated to be up to 0.181 mg total organic solids (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 5495. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and no match was found. A known source of food allergens was used in the food enzyme manufacturing process. The Panel considered that the risk of allergic reactions upon dietary exposure cannot be excluded but 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.2024.9124EC 3.2.1.80EFSA‐Q‐2023‐00423food enzymefructan β‐fructosidasefructanasegenetically 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 Andrew Chesson Lieve Herman Natália Kovalkovičová Jaime Aguilera Magdalena Andryszkiewicz Daniele Cavanna Yi Liu Safety evaluation of the food enzyme fructan β‐fructosidase from the genetically modified Trichoderma reesei strain AR‐577 EFSA Journal EC 3.2.1.80 EFSA‐Q‐2023‐00423 food enzyme fructan β‐fructosidase fructanase genetically modified microorganism |
| title | Safety evaluation of the food enzyme fructan β‐fructosidase from the genetically modified Trichoderma reesei strain AR‐577 |
| title_full | Safety evaluation of the food enzyme fructan β‐fructosidase from the genetically modified Trichoderma reesei strain AR‐577 |
| title_fullStr | Safety evaluation of the food enzyme fructan β‐fructosidase from the genetically modified Trichoderma reesei strain AR‐577 |
| title_full_unstemmed | Safety evaluation of the food enzyme fructan β‐fructosidase from the genetically modified Trichoderma reesei strain AR‐577 |
| title_short | Safety evaluation of the food enzyme fructan β‐fructosidase from the genetically modified Trichoderma reesei strain AR‐577 |
| title_sort | safety evaluation of the food enzyme fructan β fructosidase from the genetically modified trichoderma reesei strain ar 577 |
| topic | EC 3.2.1.80 EFSA‐Q‐2023‐00423 food enzyme fructan β‐fructosidase fructanase genetically modified microorganism |
| url | https://doi.org/10.2903/j.efsa.2024.9124 |
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