Safety evaluation of an extension of use of the food enzyme subtilisin from the non‐genetically modified Bacillus licheniformis strain NZYM‐CX
strain NZYM-CX 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 eight food manufacturing processes. Subsequently, the applicant has requested to extend its use to include three additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of 11 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 nine food manufacturing processes. It was calculated to be up to 2.654 mg TOS/kg body weight per day in European populations. Based on the new data, 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.
Authors
- Francesco Catania (ORCID: https://orcid.org/0000-0002-2652-9397)
- Anna Ferrandis Rosell
- José Manuel Barat Baviera
- Laurence Vernis
- Daniele Cavanna
- Baltasar Mayo
- Henk Van Loveren
- Claudia Bolognesi
- Holger Zorn
- Alicja Mortensen
- Ralf Greiner
- Gabriele Gadermaier
- Yi Liu
- Marize L. M. Solano
- Yrjö Henrik Roos
- EFSA Panel on Food Enzymes (FEZ)
Publication Details
- Journal
- EFSA Journal
- Published
- 2026-05-01
- DOI
- https://doi.org/10.2903/j.efsa.2026.10090
- Primary Topic
- Agricultural safety and regulations
- Type
- article
- Field-Weighted Citation Impact
- 0.00