Revised safety evaluation of the food enzyme aqualysin 1 from the genetically modified Bacillus subtilis 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. Dietary exposure is estimated to be up to 0.385 mg TOS/kg body weight per day in European populations. A new search for the homology of the amino acid sequence of the aqualysin 1 to known allergens was made, and matches with one food allergen, 20 respiratory allergens and three contact allergens were found. Based on the new data provided, the Panel concluded that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded. The Panel concluded that the food enzyme does not give rise to safety concerns under the intended conditions of use.