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 J. P. Cravedi (1) , Paul Fowler , Roland Franz , Konrad Grob , Rainer Gürtler , Trine Husøy , Sirpa Kärenlampi , Wim Mennes , Maria Rosaria Milana , Karla Pfaff , Gilles Rivière , Jannavi Srinivasan , Maria de Fátima Tavares Poças , Christina Tlustos , Detlef Wölfle , Holger Zorn , Andrew Chesson , Boet Glandorf , Lieve Herman , Klaus‐dieter Jany , Francesca Marcon , Andre Penninks , Andrew Smith , Henk van Loveren , Margarita Aguilera‐gomez , Magdalena Andryszkiewicz , Davide Arcella , Natalia Kovalkovicova , Yi Liu , Karl‐heinz Engel

1 ToxAlim - ToxAlim

The food enzyme is an alpha-amylase (4-alpha-D-glucan glucanohydrolase; EC 3.2.1.1), 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 alpha-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.

Mots clés: food enzyme; alpha-amylase; 4-alpha-D-glucan glucanohydrolase; NZYM-SB; genetically modified microorganism

Mots clés: Aspergillus niger

Domaines: Alimentation et Nutrition; Ingénierie des aliments

Vittorio Silano, Claudia Bolognesi, Laurence Castle, Kevin Chipman, Jean Pierre J. P. Cravedi, et al.. Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐SB). EFSA Journal, 2018, 16 (7), 21 p. ⟨10.2903/j.efsa.2018.5320⟩. ⟨hal-02620510⟩