Safety evaluation of an extension of use of a food enzyme containing bacillolysin and subtilisin activities from the non‐genetically modified Bacillus amyloliquefaciens strain AR‐383

strain AR-383 by AB Enzymes GmbH. The safety of this food enzyme was evaluated previously and it did not give rise to safety concerns when used in nine 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 12 food manufacturing processes. As the food enzyme-total organic solids (TOS) are removed in one process, the dietary exposure to the food enzyme-TOS was estimated for the remaining 11 food manufacturing processes. It was estimated to be up to 7.469 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.

Authors

Publication Details

Journal
EFSA Journal
Published
2026-04-01
DOI
https://doi.org/10.2903/j.efsa.2026.10024
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 a food enzyme containing bacillolysin and subtilisin activities from the non‐genetically modified Bacillus amyloliquefaciens strain AR‐383

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 a food enzyme containing bacillolysin and subtilisin activities from the non‐genetically modified Bacillus amyloliquefaciens strain AR‐383

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

Abstract

strain AR-383 by AB Enzymes GmbH. The safety of this food enzyme was evaluated previously and it did not give rise to safety concerns when used in nine 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 12 food manufacturing processes. As the food enzyme-total organic solids (TOS) are removed in one process, the dietary exposure to the food enzyme-TOS was estimated for the remaining 11 food manufacturing processes. It was estimated to be up to 7.469 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 37%
Agricultural safety and regulations
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