Safety of the food enzyme glucoamylase from a genetically modified Aspergillusniger (strain NZYM-BF).

Abstract

The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, consequently dietary exposure was not calculated. For brewing processes, based on the proposed maximum use levels, dietary exposure to the food enzyme–TOS was estimated to be below 3.627 mg TOS/kg body weight (bw) per day in European populations. 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 rodents. The Panel identified a no‐observed‐adverse‐effect level (NOAEL) at the highest dose of 1,360 mg TOS/kg bw per day. Similarity of the amino acid sequence to those of known allergens was searched and one match was found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the removal of TOS during the production of glucose syrups and the derived margin of exposure for brewing processes, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.