• Open Access

Scientific Opinion on Lipase from a Genetically Modified Strain of Aspergillus oryzae (strain NZYM-FL)


  • EFSA Panel on Food Contact Material, Enzymes, Flavourings and Processing Aids (CEF)

  • Panel members: Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Wim Mennes, Maria Rosaria Milana, Iona Pratt†, Kettil Svensson, Maria de Fátima Tavares Poças, Fidel Toldrá and Detlef Wölfle.
  • Correspondence: fip@efsa.europa.eu
  • Acknowledgement: The Panel wishes to thank the members of the Working Group on Enzymes: Alain Deschamps, Francis Duchiron, Karl-Heinz Engel, Thomas Haertlé, Torben Hallas-Møller, Lieve Herman, Klaus-Dieter Jany, Philippe Joudrier, Sirpa Kärenlampi, Anna Mehl, Manfred Metzler, Morten Poulsen, Fidel Toldrá, Henk van Loveren, Holger Zorn for the preparatory work on this scientific opinion and EFSA staff: Margarita Aguilera-Gomez, Anna Christodoulidou, Marina Goumenou, Anne Theobald, Rachele Tamburino and Kim Rygaard Nielsen for the support provided to this scientific opinion.
  • Adoption date: 20 June 2014
  • Published date: 11 July 2014
  • Question number: EFSA-Q-2013-00197
  • On request from: European Commission


The food enzyme considered in this opinion is a lipase (triacylglycerol lipase; EC produced with a genetically modified strain of Aspergillus oryzae. The genetic modifications do not raise safety concern. The food enzyme contains neither the production organism nor recombinant DNA. The lipase is intended to be used in a number of food manufacturing processes, such as oils, fats and eggs processing. The dietary exposure was assessed on the basis of data retrieved from the EFSA Comprehensive European Food Consumption Database. The food enzyme did not induce gene mutations in bacteria nor chromosome aberrations in human lymphocytes. Therefore, there is no concern with respect to genotoxicity. The systemic toxicity was assessed by means of a 90-day subchronic oral toxicity study in rodents. A No Observed Adverse Effect Level was derived, which compared with the dietary exposure results in a sufficiently high Margin of Exposure. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens. The Panel considered that the likelihood of food allergic reactions to the enzyme is low and therefore does not raise safety concern. Based on the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided and the toxicological studies, this food enzyme does not raise safety concern under the intended conditions of use.