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

EFSA Journal 2014;12(5):3645 [17 pp.]. doi:10.2903/j.efsa.2014.3645
  EFSA Panel on Food Contact Materials, 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. Acknowledgment 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. Contact fip@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: European Commission Question number: EFSA-Q-2012-00897 Adopted: 09 April 2014 Published: 14 May 2014 Last updated: 03 September 2014. This version replaces the previous one/s. Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

The food enzyme considered in this opinion is a xylanase (endo-1,4-β-xylanase; EC 3.2.1.8) 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 xylanase is intended to be used in a number of food manufacturing processes, such as starch processing, beverage alcohol (distilling), brewing, baking and other cereal based processes. The dietary exposure was assessed according to the Budget method. The food enzyme did not induce gene mutations in bacteria nor chromosome aberrations in human peripheral blood 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.

© European Food Safety Authority, 2014

Summary

Following a request from the European Commission, the EFSA Panel on Food Contact Material, Enzymes, Flavourings and Processing Aids (CEF Panel) was asked to deliver a scientific opinion on the food enzyme xylanase (endo-1,4-β-xylanase; EC 3.2.1.8) produced with the genetically modified Aspergillus oryzae strain NZYM-FB. 

The A. oryzae parental strain has a long history of use for the production of food enzymes. It has been modified in order to produce and secrete xylanase and to prevent or decrease the production of undesirable secondary metabolites. The genetic modifications do not raise safety concern.

The food enzyme contains neither the production organism nor recombinant DNA, given the limits of detection.

The food enzyme has been characterised by determining the temperature and pH optima and the thermo-stability. Its composition is verified by measuring the content of protein, ash, water, heavy metals and Total Organic Solids. The A. oryzae parental strain has been modified in order to prevent the production of cyclopiazonic acid and to decrease the potential production of kojic acid. The absence of cyclopiazonic acid, β-nitropropionic acid and kojic acid was demonstrated, given the limits of detection.

The food enzyme is intended to be used in a number of food manufacturing processes, such as starch processing, beverage alcohol (distilling), brewing, baking and other cereal based processes. The typical uses and the use levels recommended for specific food processes have been provided.

The Theoretical Maximum Daily Intake was calculated according to the Budget method.

The genotoxicity of the food enzyme was assessed by means of two in vitro assays (gene mutations in bacteria and chromosome aberrations in human lymphocytes). The food enzyme, produced with the genetically modified A. oryzae strain NZYM-FB, did not to induce gene mutations in bacteria with or without metabolic activation when tested under the conditions employed in the study as presented by the applicant. Neither did it induce chromosome aberrations in cultured human blood lymphocytes under the test conditions employed for this study.

The systemic toxicity was assessed by means of a 90-day subchronic oral toxicity study in rodents.  A No Observed Adverse Effect Level (NOAEL) was derived, which compared with the dietary exposure results in a sufficiently high Margin of Exposure.

The CEF Panel considers that the likelihood of food allergic reactions to this xylanase produced with this genetically modified strain of A. oryzae 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, the Panel concluded that this food enzyme does not raise safety concern under the intended conditions of use.

Keywords

food enzyme, xylanase, endo-1,4-β-xylanase, EC 3.2.1.8, 1,4-β-D-Xylan xylanohydrolase, Aspergillus oryzae, genetically modified microorganism