Safety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus licheniformis strain NZYM‐AC
2023
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) | Claude Lambré | José Manuel Barat Baviera | Claudia Bolognesi | Pier Sandro Cocconcelli | Riccardo Crebelli | David Michael Gott | Konrad Grob | Evgenia Lampi | Marcel Mengelers | Alicja Mortensen | Gilles Rivière | Inger‐Lise Steffensen | Christina Tlustos | Henk Van Loveren | Laurence Vernis | Holger Zorn | Lieve Herman | Yrjö Roos | Magdalena Andryszkiewicz | Cristina Fernàndez‐Fraguas | Ana Gomes | Yi Liu | Giulio diPiazza | Andrew Chesson
Abstract The food enzyme α‐amylase (1,4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain NZYM‐AC by Novozymes A/S. The genetic modifications do not give rise to safety concerns and the production strain meets the requirements for the qualified presumption of safety (QPS) approach. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in seven food manufacturing processes: processing of cereals and other grains for the production of glucose syrups and other starch hydrolysates, cereal‐based products other than baked, brewed products and distilled alcohol; processing of fruits and vegetables for the production of juices and products other than juices; production of refined and unrefined sugars. Since the residual amounts of total organic solids (TOS) are removed during two processes, dietary exposure was calculated only for the remaining five food manufacturing processes. It was estimated to be up to 0.167 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of concerns resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found with a respiratory allergen. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded (except for distilled alcohol production), but the likelihood is 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.
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