Revised safety evaluation of the food enzyme protein‐glutamine γ‐glutamyltransferase from the non‐genetically modified Streptomyces mobaraensis strain M2020197

The food enzyme protein‐glutamine γ‐glutamyltransferase (EC 2.3.2.13) is produced with the non‐genetically modified Streptomyces mobaraensis strain M2020197 by Dongsheng Biotech (Taixing) Co., Ltd. In a previous opinion, the Panel could not exclude safety concerns due to insufficient margins of exposure. In addition, the taxonomic identity of the production strain was not established, the absence of genes of concern was not confirmed, and the absence of viable cells of the production strain was not demonstrated. As a follow‐up, the applicant reduced the use levels in the food manufacturing processes. In addition, the applicant provided new data on the identification and characterisation of the production strain. The food enzyme was considered free from viable cells of the production organism and its DNA. The dietary exposure was revised to be up to 0.240 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (91 mg TOS/kg bw per day), the Panel derived a margin of exposure of at least 379. A search for the homology of the amino acid sequence of the protein‐glutamine γ‐glutamyltransferase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, but that the likelihood is low. A risk of contribution to coeliac disease cannot be excluded. Based on the new data, the revised margin of exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.