Safety evaluation of the food enzyme subtilisin from the genetically modified <i>Bacillus subtilis</i> strain DP-Ezx62.

ABSTRACT: The food enzyme subtilisin (EC 3.4.21.62) is produced with the genetically modified Bacillus subtilis strain DP-Ezx62 by Danisco US Inc. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene, and consequently, it does not fulfil the requirements for the qualified presumption of safety (QPS) approach to safety assessment. However, considering the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. As no other concerns arising from the microbial source and its subsequent genetic modification 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 int

SUBMITTER: EFSA Panel on Food Enzymes (FEZ) 

PROVIDER: S-EPMC12511883 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature