Revised safety evaluation of the food enzyme aqualysin 1 from the genetically modified <i>Bacillus subtilis</i> strain LMG S-25520 produced by a modified process.

ABSTRACT: The food enzyme aqualysin 1 (EC 3.4.21.111) is produced with the genetically modified Bacillus subtilis strain LMG S-25520 by Puratos N.V. In a previous evaluation, the Panel could not exclude safety concerns due to an insufficient margin of exposure and noted the presence of recombinant DNA in all food enzyme batches tested. As a follow-up, the applicant changed the manufacturing process and provided new data. These data established that the production strain meets the requirements for qualified presumption of safety (QPS) status, and no concerns arose from the modified food enzyme manufacturing process; hence, toxicological tests were not considered necessary. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in baking processes.

SUBMITTER: EFSA Panel on Food Enzymes (FEZ) 

PROVIDER: S-EPMC11897802 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature