Safety evaluation of the food enzyme glutaminase from the genetically modified Bacillus subtilis strain Glu3‐3

strain Glu3-3 by Angel Yeast Co., Ltd. The production strain of the food enzyme contains multiple copies of acquired antimicrobial resistance genes. The food enzyme was considered free of viable cells of the production strain, but the absence of DNA was not demonstrated. As no other concerns arising from the microbial source or from the manufacturing process have been identified, the Panel considered that toxicological tests are not needed for the assessment of this food enzyme. The food enzyme is intended to be used in seven food manufacturing processes. Dietary exposure was estimated to be up to 29.311 mg total organic solids/kg body weight per day in European populations. A search for the homology of the amino acid sequence of the glutaminase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure cannot be excluded, but that the likelihood is low. Because the absence of DNA from the production organism in the food enzyme was not demonstrated, the Panel could not conclude on the safety of the food enzyme.

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Publication Details

Journal
EFSA Journal
Published
2026-05-01
DOI
https://doi.org/10.2903/j.efsa.2026.10088
Primary Topic
Occupational exposure and asthma
Type
article
Field-Weighted Citation Impact
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article

Safety evaluation of the food enzyme glutaminase from the genetically modified Bacillus subtilis strain Glu3‐3

Francesco Catania, José Manuel Barat Baviera, Laurence Vernis, Daniele Cavanna et al.
EFSA Journal
Occupational exposure and asthma
article

Safety evaluation of the food enzyme glutaminase from the genetically modified Bacillus subtilis strain Glu3‐3

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

Abstract

strain Glu3-3 by Angel Yeast Co., Ltd. The production strain of the food enzyme contains multiple copies of acquired antimicrobial resistance genes. The food enzyme was considered free of viable cells of the production strain, but the absence of DNA was not demonstrated. As no other concerns arising from the microbial source or from the manufacturing process have been identified, the Panel considered that toxicological tests are not needed for the assessment of this food enzyme. The food enzyme is intended to be used in seven food manufacturing processes. Dietary exposure was estimated to be up to 29.311 mg total organic solids/kg body weight per day in European populations. A search for the homology of the amino acid sequence of the glutaminase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure cannot be excluded, but that the likelihood is low. Because the absence of DNA from the production organism in the food enzyme was not demonstrated, the Panel could not conclude on the safety of the food enzyme.

EFSA JournalVol. 24(5)
Openalex Percentile: Top 8%
Occupational exposure and asthma
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