Safety evaluation of an extension of use of the food enzyme subtilisin from the genetically modified Bacillus licheniformis strain NZYM‐CB

strain NZYM-CB 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 six food manufacturing processes. Subsequently, the applicant has requested to extend its use to three additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of nine 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 seven food manufacturing processes. It was calculated to be up to 1.391 mg TOS/kg body weight per day in European populations. Based on the revised dietary 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.

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Publication Details

Journal
EFSA Journal
Published
2026-04-01
DOI
https://doi.org/10.2903/j.efsa.2026.10026
Primary Topic
Agricultural safety and regulations
Type
article
Field-Weighted Citation Impact
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article

Safety evaluation of an extension of use of the food enzyme subtilisin from the genetically modified Bacillus licheniformis strain NZYM‐CB

Francesco Catania, José Manuel Barat Baviera, Laurence Vernis, Daniele Cavanna et al.
EFSA Journal
Agricultural safety and regulations
article

Safety evaluation of an extension of use of the food enzyme subtilisin from the genetically modified Bacillus licheniformis strain NZYM‐CB

Francesco Catania, José Manuel Barat Baviera, Laurence Vernis, Daniele Cavanna, Baltasar Mayo, Holger Zorn, Claudia Bolognesi, Henk Van Loveren, Ralf Greiner, Alicja Mortensen, Yi Liu, Marize L. M. Solano, Yrjö Henrik Roos, Valentina Tokić, Gabriele Gadermaier, EFSA Panel on Food Enzymes (FEZ)
article en

Abstract

strain NZYM-CB 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 six food manufacturing processes. Subsequently, the applicant has requested to extend its use to three additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of nine 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 seven food manufacturing processes. It was calculated to be up to 1.391 mg TOS/kg body weight per day in European populations. Based on the revised dietary 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.

EFSA JournalVol. 24(4)
Openalex Percentile: Top 28%
Agricultural safety and regulations
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Safety evaluation of an extension of use of the food enzyme subtilisin from the genetically modified Bacillus licheniformis strain NZYM‐CB — Francesco Catania, José Manuel Barat Baviera, et al. · EFSA Journal (2026) | TGRS Research Map | TGRS