Safety evaluation of the food enzyme α‐amylase from Aspergillus oryzae (strain DP‐Bzb41)
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 glucanohydrolase, EC 126.96.36.199) is produced with a non‐genetically modified Aspergillus oryzae (strain DP‐Bzb41) by Danisco US Inc. (USA). The α‐amylase food enzyme is intended to be used in baking, brewing, distilled alcohol production and starch processing for the glucose syrup production. Based on the maximum use levels for baking and 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 2.59 mg TOS/kg body weight (bw) per day. Since residual amounts of TOS are removed during distilled alcohol production and by the purification steps applied during starch processing, dietary exposure for these processes was not calculated. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) of 1,000 mg TOS/kg bw per day, the highest dose tested. Comparison with the estimated dietary exposure, results in a margin of exposure of at least 386. Similarity of the amino acid sequence to those of known allergens was searched and one match to respiratory allergen was found (an amylase from another strain of A. oryzae). The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood 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.