Safety evaluation of the food enzyme maltogenic amylase from genetically modified Escherichia coli (strain BLASC)

• Published in: EFSA journal Vol. 17; no. 7; pp. e05769 - n/a
• Main Authors: Silano, Vittorio, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Glandorf, Boet, Herman, Lieve, Jany, Klaus‐Dieter, Marcon, Francesca, Penninks, André, Arcella, Davide, Gomes, Ana, Kovalkovičová, Natália, Liu, Yi, Maia, Joaquim, Roncancio Peña, Claudia, Nuin, Irene, Chesson, Andrew
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 01.07.2019; John Wiley and Sons Inc; Wiley
• Subjects: 1,4‐α‐maltohydrolase; Allergens; Amino acid sequence; Amino acids; Amylases; Baking; Body weight; Breweries; Brewing; Deoxyribonucleic acid; Diet; DNA; Dosage; E coli; EC 3.2.1.133; Enzymes; Escherichia coli; Escherichia coli; Exposure; Fermentation; Food; Food additives; food enzyme; Food processing; Food safety; Genetic modification; genetically modified microorganism; Genotoxicity; Glucan; Glucan 1,4-a-maltohydrolase; Glucose; Good Manufacturing Practice; Hypersensitivity; maltogenic amylase; Manufacturing; Microorganisms; Organic solids; Process controls; Proteins; Recombinant DNA; Risk assessment; Safety; Scientific Opinion; Starch; Syrups; Toxicity; Escherichia coli; food enzyme; genetically modified microorganism; EC 3.2.1.133; maltogenic amylase; glucan; 1,4‐α‐maltohydrolase
• ISSN: 1831-4732; 1831-4732; 2314-9396
• DOI: 10.2903/j.efsa.2019.5769

The food enzyme, a maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133), is produced with a genetically modified Escherichia coli strain BLASC by Advanced Enzyme Technologies Ltd. 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 maltogenic amylase is intended to be used in baking and brewing processes and starch processing for the production of glucose syrups. 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 this food process. For baking and brewing processes, based on the maximum use levels recommended for food processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–TOS was estimated to be up to 0.107 mg TOS/kg body weight (bw) per day. 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 at the highest dose tested of 838 mg TOS/kg bw per day that, compared with the estimated dietary exposure, resulted in a sufficiently high margin of exposure (at least 7,800). Similarity of the amino acid sequence to those of known allergens was searched and one match was found with respiratory allergen produced by Aspergillus oryzae. The Panel considered that, under the intended conditions of use, the risk for allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood of such reaction to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.