Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

• Published in: EFSA journal 2018-10, Vol.16 (10), p.e05451-n/a
• Main Authors: Silano, Vittorio, Barat Baviera, José Manuel, Bolognesi, Claudia, Brüschweiler, Beat Johannes, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mortensen, Alicja, Riviere, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Kärenlampi, Sirpa, Marcon, Francesca, Penninks, André, Smith, Andrew, Aguilera‐Gómez, Margarita, Andryszkiewicz, Magdalena, Arcella, Davide, Kovalkovičová, Natália, Liu, Yi, Rossi, Annamaria, Engel, Karl‐Heinz, Chesson, Andrew
• Format: Article
• Language: English
• Subjects: 1,4‐α‐d‐glucan glucanohydrolase; 4‐α‐d‐glucan glucanohydrolase; Alcoholic beverages; Allergens; Amino acid sequence; Amino acids; Amylases; Aspergillus niger; Aspergillus niger; Baking; Body weight; Distillation; Dosage; EC 3.2.1.1; Enzymes; Exposure; Fermentation; Food; Food additives; Food allergies; food enzyme; Food Ingredients and Packaging; Food safety; Genetic modification; genetically modified microorganism; Genotoxicity; Glucan; Glucose; Good Manufacturing Practice; Manufacturing; Microorganisms; Organic solids; Process controls; Recombinant DNA; Safety; Scientific Opinion; Syrups; Toxicity; α‐amylase
• ISSN: 1831-4732; 1831-4732
• DOI: 10.2903/j.efsa.2018.5451

The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) 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 α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking processes. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups, consequently dietary exposure was not calculated. For baking processes, based on the proposed maximum use levels, dietary exposure to the food enzyme–TOS was estimated to be up to 3.784 mg TOS/kg body weight 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 1,400 mg TOS/kg body weight (bw) per day. Similarity of the amino acid sequence to those of known allergens was searched and two matches were 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 baking processes, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.