Safety evaluation of the food enzyme alpha‐amylase from non‐genetically modified Aspergillus niger strain (strain DP‐Azb60)
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 alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 18.104.22.168) is produced with a non‐genetically modified Aspergillus niger (strain DP‐Azb60) by Danisco US Inc. The food enzyme is free from viable cells of the production organism. The α‐amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.503 mg TOS/kg body weight (bw) per day. Genotoxicity tests with the food enzyme did not indicate a genotoxic 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) at the highest dose of 1,000 mg TOS/kg bw per day that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure (of at least 1,988). Similarity of the amino acid sequence to those of known allergens was searched and one match was found to Asp o 21, an alpha‐amylase from Aspergillus oryzae. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered 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.