Revised dietary exposure assessment of the food enzyme endo 1,4‐β‐xylanase from the genetically modified Aspergillus oryzae strain NZYM‐FB
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 oryzae strain NZYM‐FB by Novozymes A/S. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that, under the intended condition...
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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.2024.9163 |
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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 endo 1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified Aspergillus oryzae strain NZYM‐FB 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 five food manufacturing processes and recalculated the dietary exposure. As the food enzyme‐total organic solids (TOS) are removed in two food manufacturing processes, the dietary exposure to the food enzyme‐TOS was estimated only for the remaining three processes. It was calculated to be up to 0.383 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (106 mg TOS/kg bw per day, the lowest dose tested), the Panel derived a margin of exposure of at least 277. 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-264bc9fb5da44f008a2aacb681b00869 |
| institution | Kabale University |
| issn | 1831-4732 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-264bc9fb5da44f008a2aacb681b008692025-01-17T06:31:16ZengWileyEFSA Journal1831-47322024-12-012212n/an/a10.2903/j.efsa.2024.9163Revised dietary exposure assessment of the food enzyme endo 1,4‐β‐xylanase from the genetically modified Aspergillus oryzae strain NZYM‐FBEFSA 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 endo 1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified Aspergillus oryzae strain NZYM‐FB 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 five food manufacturing processes and recalculated the dietary exposure. As the food enzyme‐total organic solids (TOS) are removed in two food manufacturing processes, the dietary exposure to the food enzyme‐TOS was estimated only for the remaining three processes. It was calculated to be up to 0.383 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (106 mg TOS/kg bw per day, the lowest dose tested), the Panel derived a margin of exposure of at least 277. 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.2024.9163Aspergillus oryzaeEC 3.2.1.8EFSA‐Q‐2012‐00897EFSA‐Q‐2024‐00607endo 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 Daniele Cavanna Yi Liu Revised dietary exposure assessment of the food enzyme endo 1,4‐β‐xylanase from the genetically modified Aspergillus oryzae strain NZYM‐FB EFSA Journal Aspergillus oryzae EC 3.2.1.8 EFSA‐Q‐2012‐00897 EFSA‐Q‐2024‐00607 endo 1,4‐β‐xylanase food enzyme |
| title | Revised dietary exposure assessment of the food enzyme endo 1,4‐β‐xylanase from the genetically modified Aspergillus oryzae strain NZYM‐FB |
| title_full | Revised dietary exposure assessment of the food enzyme endo 1,4‐β‐xylanase from the genetically modified Aspergillus oryzae strain NZYM‐FB |
| title_fullStr | Revised dietary exposure assessment of the food enzyme endo 1,4‐β‐xylanase from the genetically modified Aspergillus oryzae strain NZYM‐FB |
| title_full_unstemmed | Revised dietary exposure assessment of the food enzyme endo 1,4‐β‐xylanase from the genetically modified Aspergillus oryzae strain NZYM‐FB |
| title_short | Revised dietary exposure assessment of the food enzyme endo 1,4‐β‐xylanase from the genetically modified Aspergillus oryzae strain NZYM‐FB |
| title_sort | revised dietary exposure assessment of the food enzyme endo 1 4 β xylanase from the genetically modified aspergillus oryzae strain nzym fb |
| topic | Aspergillus oryzae EC 3.2.1.8 EFSA‐Q‐2012‐00897 EFSA‐Q‐2024‐00607 endo 1,4‐β‐xylanase food enzyme |
| url | https://doi.org/10.2903/j.efsa.2024.9163 |
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