Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Aspergillus oryzae strain NZYM-LJ.

Abstract

The food enzyme phospholipase A1 (phosphatidylcholine 1-acylhydrolase; EC 3.1.1.32) is produced with the genetically modified Aspergillus oryzae strain NZYM-LJ 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 its DNA. The food enzyme is intended to be used in baking processes. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.09 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 957.3 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 10,600. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found. The Panel considered that, under the intended conditions of use the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur 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.

• Authors: 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, Magdalena Andryszkiewicz, Giulio di Piazza, Natalia Kovalkovicova, Yi Liu, Andrew Chesson
• Journal: EFSA journal. European Food Safety Authority (EFSA J) Vol. 20 Issue 7 Pg. e07381 (Jul 2022) ISSN: 1831-4732 [Electronic] United States
• PMID: 35822071 (Publication Type: Journal Article)
• Copyright: © 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.