Updated safety evaluation of the food enzyme catalase from the non‐genetically modified Aspergillus tubingensis strain AE‐CN

strain AE-CN by Amano Enzyme Inc. The food enzyme is intended to be used in seven food manufacturing processes. In a previous evaluation, the Panel could not conclude on the safety of this food enzyme due to uncertainties about the absence of viable cells of the production organism in the food enzyme and to the clastogenic effects observed in the in vitro genotoxicity studies, which could not be dismissed due to limitations in the in vivo studies. In this assessment, the Panel evaluated new data provided by the applicant and completed the safety evaluation of this food enzyme. The new data demonstrated the absence of viable cells of the production organism in the food enzyme and showed no concerns on genotoxicity. Based on the new data provided and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

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Publication Details

Journal
EFSA Journal
Published
2026-05-01
DOI
https://doi.org/10.2903/j.efsa.2026.10082
Primary Topic
Carcinogens and Genotoxicity Assessment
Type
article
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article

Updated safety evaluation of the food enzyme catalase from the non‐genetically modified Aspergillus tubingensis strain AE‐CN

Francesco Catania, José Manuel Barat Baviera, Laurence Vernis, Daniele Cavanna et al.
EFSA Journal
Carcinogens and Genotoxicity Assessment
article

Updated safety evaluation of the food enzyme catalase from the non‐genetically modified Aspergillus tubingensis strain AE‐CN

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

Abstract

strain AE-CN by Amano Enzyme Inc. The food enzyme is intended to be used in seven food manufacturing processes. In a previous evaluation, the Panel could not conclude on the safety of this food enzyme due to uncertainties about the absence of viable cells of the production organism in the food enzyme and to the clastogenic effects observed in the in vitro genotoxicity studies, which could not be dismissed due to limitations in the in vivo studies. In this assessment, the Panel evaluated new data provided by the applicant and completed the safety evaluation of this food enzyme. The new data demonstrated the absence of viable cells of the production organism in the food enzyme and showed no concerns on genotoxicity. Based on the new data provided and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

EFSA JournalVol. 24(5)
Openalex Percentile: Top 8%
Carcinogens and Genotoxicity Assessment
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Updated safety evaluation of the food enzyme catalase from the non‐genetically modified Aspergillus tubingensis strain AE‐CN — Francesco Catania, José Manuel Barat Baviera, et al. · EFSA Journal (2026) | TGRS Research Map | TGRS