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Safety evaluation of an extension of use of the food enzyme endo 1,4-β-xylanase from the genetically modified Aspergillus oryzae strain NZYM-FB
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DOI：10.2903/j.efsa.2026.10181.png)
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Abstract
En 中文
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. The safety of this food enzyme was evaluated previously and it did not give rise to safety concerns when used in five food manufacturing processes. Subsequently, the applicant has requested to extend its use to include one additional process. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of six food manufacturing processes. As the food enzyme–Total Organic Solids (TOS) are removed in two processes, the dietary exposure to the food enzyme–TOS was estimated for the remaining four food manufacturing processes. It was estimated to be up to 0.390 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 Panel derived a margin of exposure of at least 272. 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.
Keywords:
Aspergillus oryzae
EFSA-Q-2012-00897
EFSA-Q-2024-00607
EFSA-Q-2025-00573
endo-1,4-β-xylanase
EC 3.2.1.8
food enzyme
genetically modified microorganism
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