Safety evaluation of the food enzyme β‐galactosidase from the non‐genetically modified Aspergillus oryzae strain AE‐LA

• Published in: EFSA journal 2022-10, Vol.20 (10), p.e07569-n/a
• Main Authors: Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Roos, Yrjö, Andryszkiewicz, Magdalena, Gomes, Ana, Liu, Yi, Piazza, Giulio, Rainieri, Sandra, Ferreira de Sousa, Rita, Chesson, Andrew
• Format: Article
• Language: English
• Subjects: Allergens; Allergic reactions; Amino acid sequence; Amino acids; Aspergillus oryzae; Body weight; Dairy products; EC 3.2.1.23; Enzymes; Exposure; Fermentation; Fermented milk products; Food; Food additives; Food allergies; Food enzyme; Food safety; Galactosidase; Galactosides; Genetic modification; Genotoxicity; lactase; Lactose; Manufacturing; Milk; Milk products; Organic solids; Process controls; Proteins; Safety; Scientific Opinion; Toxicity; Whey; β‐d‐galactoside galactohydrolase; β‐galactosidase
• ISSN: 1831-4732; 1831-4732
• DOI: 10.2903/j.efsa.2022.7569

The food enzyme β‐galactosidase (β‐d‐galactoside galactohydrolase; EC 3.2.1.23) is produced with the non‐genetically modified Aspergillus oryzae strain AE‐LA by Amano Enzyme Inc. The food enzyme was considered free from viable cells of the production organism. The food enzyme is intended to be used for lactose hydrolysis in milk processing, production of fermented milk products, whey processing and the manufacture of enzyme‐modified dairy ingredients. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.651 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate 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 of 1,656 mg TOS/kg bw per day, the highest dose tested. This results in a margin of exposure of at least 1,003. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is considered to be low. Based on the data provided, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.