Safety evaluation of the food enzyme α‐amylase from a genetically modified strain of Bacillus licheniformis (DP‐Dzb25)
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 (4‐α‐d‐glucan glucanhydrolase; EC 18.104.22.168) is produced with the genetically modified strain Bacillus licheniformis DP‐Dzb25 by Danisco US Inc. It is intended to be used in distilled alcohol production, starch processing for the production of glucose syrups, and in brewing processes. Since residual amounts of the food enzyme are removed by distillation and during starch processing, no dietary exposure was calculated for these food 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 0.138 mg TOS/kg body weight (bw) per day. 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 considers that toxicological tests are not needed for the assessment of this food enzyme. Similarity of the amino acid sequence to those of known allergens was searched for and no match was found. The Panel notes that the food enzyme may contain a known allergen. Therefore, allergenicity cannot be excluded for uses other than distilled alcohol production. Apart from potential allergenicity, the Panel concluded that the food enzyme 4‐α‐d‐glucan glucanhydrolase produced with the genetically modified B. licheniformis strain DP‐Dzb25 does not give rise to safety concerns under the intended conditions of use.