Safety evaluation of the food enzyme α‐amylase from the Parageobacillus thermoglucosidasius strain DP‐Gzb47
Note: The full opinion will be published in accordance with Article 12 of Regulation (EC) No 1331/2008 once the decision on confidentiality will be received from the European Commission.
The food enzyme α‐amylase (1,4‐α‐d‐glucan glucanohydrolase; EC 18.104.22.168) is produced with a non‐genetically modified Parageobacillus thermoglucosidasius strain DP‐Gzb47 by Danisco US Inc. The α‐amylase food enzyme is intended to be used in brewing processes and distilled alcohol production. Since residual amounts of the food enzyme are removed by distillation, dietary exposure was only calculated for brewing processes. Based on the maximum use levels recommended for brewing processes, and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 0.880 mg TOS/kg body weight (bw) per day in European populations. As the production strain of P. thermoglucosidasius meets the requirements for a Qualified Presumption of Safety (QPS) approach, no toxicological data are required. Similarity of the amino acid sequence to those of known allergens was searched for and no match was found. The Panel considered that under the intended conditions of use, other than distilled alcohol production, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.