Safety evaluation of an extension of use of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Aspergillus niger strain XEA
Abstract The food enzyme endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified Aspergillus niger strain XEA 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 no...
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Wiley
2025-03-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2025.9328 |
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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 Maria Chiara Sicuri 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 Maria Chiara Sicuri Daniele Cavanna Yi Liu |
| author_sort | EFSA Panel on Food Enzymes (FEZ) |
| collection | DOAJ |
| description | Abstract The food enzyme endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified Aspergillus niger strain XEA 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 two food manufacturing processes. Subsequently, the applicant has requested to extend its use to include four additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of six food manufacturing processes. The dietary exposure was calculated to be up to 0.316 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 (1852 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 5861. 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. |
| format | Article |
| id | doaj-art-e3c3928fa6014fb1a4c8c62333c49667 |
| institution | DOAJ |
| issn | 1831-4732 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-e3c3928fa6014fb1a4c8c62333c496672025-08-20T02:53:44ZengWileyEFSA Journal1831-47322025-03-01233n/an/a10.2903/j.efsa.2025.9328Safety evaluation of an extension of use of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Aspergillus niger strain XEAEFSA Panel on Food Enzymes (FEZ)Holger ZornJosé Manuel Barat BavieraClaudia BolognesiFrancesco CataniaGabriele GadermaierRalf GreinerBaltasar MayoAlicja MortensenYrjö Henrik RoosMarize L. M. SolanoMonika SramkovaHenk Van LoverenLaurence VernisMaria Chiara SicuriDaniele CavannaYi LiuAbstract The food enzyme endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified Aspergillus niger strain XEA 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 two food manufacturing processes. Subsequently, the applicant has requested to extend its use to include four additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of six food manufacturing processes. The dietary exposure was calculated to be up to 0.316 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 (1852 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 5861. 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.2025.9328Aspergillus nigerEC 3.2.1.8EFSA‐Q‐2015‐00045EFSA‐Q‐2024‐00452endo‐1,4‐β‐xylanasefood enzyme |
| 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 Maria Chiara Sicuri Daniele Cavanna Yi Liu Safety evaluation of an extension of use of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Aspergillus niger strain XEA EFSA Journal Aspergillus niger EC 3.2.1.8 EFSA‐Q‐2015‐00045 EFSA‐Q‐2024‐00452 endo‐1,4‐β‐xylanase food enzyme |
| title | Safety evaluation of an extension of use of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Aspergillus niger strain XEA |
| title_full | Safety evaluation of an extension of use of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Aspergillus niger strain XEA |
| title_fullStr | Safety evaluation of an extension of use of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Aspergillus niger strain XEA |
| title_full_unstemmed | Safety evaluation of an extension of use of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Aspergillus niger strain XEA |
| title_short | Safety evaluation of an extension of use of the food enzyme endo‐1,4‐β‐xylanase from the genetically modified Aspergillus niger strain XEA |
| title_sort | safety evaluation of an extension of use of the food enzyme endo 1 4 β xylanase from the genetically modified aspergillus niger strain xea |
| topic | Aspergillus niger EC 3.2.1.8 EFSA‐Q‐2015‐00045 EFSA‐Q‐2024‐00452 endo‐1,4‐β‐xylanase food enzyme |
| url | https://doi.org/10.2903/j.efsa.2025.9328 |
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