Safety evaluation of the food enzyme α-amylase from a genetically modified Aspergillus niger (strain NZYM-SB)

Vittorio Silano, Claudia Bolognesi, Laurence Castle, Kevin Chipman, Jean-Pierre Cravedi, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, Karla Pfaff, Gilles Riviere, Jannavi Srinivasan, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle, Holger ZornAndrew Chesson, Boet Glandorf, Lieve Herman, Klaus-Dieter Jany, Francesca Marcon, André Penninks, Andrew Smith, Henk Van Loveren, Davor Želježić, Margarita Aguilera-Gómez, Magdalena Andryszkiewicz, Davide Arcella, Natália Kovalkovičová, Yi Liu, Karl-Heinz Engel, EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

Research output: Contribution to specialist publicationArticle

2 Downloads (Pure)


The food enzyme is an α-amylase (4-α-d-glucan glucanohydrolase; EC, produced with the genetically modified Aspergillus niger strain NZYM-SB by Novozymes A/S. The food enzyme does not contain the production organism or its DNA; therefore, there is no safety concern for the environment. The α-amylase is intended for use in starch processing, beverage alcohol (distilling) processes and baking processes. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups (by > 99%). Consequently, dietary exposure was not calculated for these two uses. Based on the maximum use levels recommended for the baking processes and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme-TOS was estimated to be up to 3.075 mg TOS/kg body weight per day in European populations. The food enzyme did not induce gene mutations in bacteria or micronuclei in human lymphocytes. Subchronic toxicity was assessed by means of a repeated-dose 90-day oral toxicity study in rodents. A no observed adverse effect level (NOAEL) was derived that, compared with the dietary exposure, resulted in a sufficiently high margin of exposure (MOE). Similarity of the amino acid sequence to those of known allergens was searched and two matches were found. The Panel considered that the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Based on the genetic modifications, the manufacturing process, the compositional and biochemical data, the findings in the toxicological and genotoxicity studies, as well as the estimated dietary exposure, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Original languageEnglish
Number of pages21
Specialist publicationEFSA Journal
Publication statusPublished - 20 Jul 2018

Bibliographical note

Acknowledgements: The Panel wishes to thank EFSA staff members: Jaime Aguilera, Ana Gomes,Christine Horn, Joaquim Maia and Annamaria Rossi for the support provided to this scientic output


  • food enzyme
  • a-amylase
  • 4-a-D-glucan glucanohydrolase
  • EC
  • Aspergillus nige
  • genetically modied microorganism


Dive into the research topics of 'Safety evaluation of the food enzyme α-amylase from a genetically modified Aspergillus niger (strain NZYM-SB)'. Together they form a unique fingerprint.

Cite this