Safety evaluation of the food enzyme α-amylase from a genetically modified Bacillus licheniformis (strain NZYM-AV)

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 Želježic, Jaime Aguilera, Margarita Aguilera-Gómez, Natália Kovalkovicová, Joaquim Maia, Annamaria Rossi, Karl-Heinz Engel, EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

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The food enzyme is an α-amylase (4-α-d-glucan glucanohydrolase; EC produced with the genetically modified Bacillus licheniformis strain NZYM-AV by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme does not contain the production microorganism or its DNA; therefore, there is no safety concern for the environment. The α-amylase is intended to be used in starch processing for the production of glucose syrups and distilled alcohol production. 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. Genotoxicity tests did not raise a safety concern. The subchronic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. The Panel derived a no observed adverse effect level (NOAEL) at the highest dose level of 796 mg TOS/kg body weight (bw) per day. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens and one match was found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Based on the microbial source, the genetic modifications, the manufacturing process, the compositional and biochemical data, the removal of TOS during the intended food production processes and the toxicological and genotoxicity studies, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Original languageEnglish
Number of pages14
Specialist publicationEFSA Journal
Publication statusPublished - 12 Jul 2018

Bibliographical note

© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.


  • food enzyme
  • a-amylase
  • 4-a-D-glucan
  • glucanohydrolase
  • EC
  • 1,4-a-D-glucan
  • Bacillus licheniformis
  • genetically modified microorganism


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