Safety evaluation of the food enzyme aqualysin 1 from a genetically modified Bacillus subtilis (strain LMGS 25520)

. Efsa Panel On Food Contact Materials, Enzymes, Flavourings And Processing Aids (cef) (1) , Vittorio Silano , Claudia Bolognesi , Laurence Castle , Kevin Chipman , Jean Pierre J. P. Cravedi (2) , 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 , Margarita Aguilera‐gomez , Magdalena Andryszkiewicz , Davide Arcella , Natalia Kovalkovicova , Yi Liu , Karl‐heinz Engel

1 EFSA - European Food Safety Authority
2 ToxAlim - ToxAlim

The food enzyme considered in this opinion is aquaiysin 1 (EC 3,4.21.111), produced from the genetically modified strain Bacillus subtilis LMGS 25520 by Puratos NV. The production strain was not detected in the food enzyme. Aquaiysin 1 is intended to be used in baking processes. Based on the maximum use level recommended and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 2.13 mg TOS/kg body weight per day in European populations. Genotoxicity tests indicated no genotoxic concerns. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens and 23 matches were found (20 respiratory and 3 dermal allergens). However, the Panel considered that there are no indications for food allergic reactions to the food enzyme. The genetic modifications performed, the manufacturing process, the compositional and biochemical data, the allergenicity and the genotoxicity assessment did not raise safety concerns. The Panel considered the margin of exposure (MOE) calculated from the no observed adverse effect level (INOAEL) determined from the repeated dose 90-day oral toxicity study and the estimated dietary exposure as insufficient to conclude that there is no safety concern for this food enzyme under the intended conditions of use. The Panel noted that recombinant DNA was present in all batches of the food enzyme tested.

Mots clés: food enzyme; aqualysin 1; genetically modified microorganism

Mots clés: Bacillus subtilis

Domaines: Alimentation et Nutrition; Ingénierie des aliments

. Efsa Panel On Food Contact Materials, Enzymes, Flavourings And Processing Aids (cef), Vittorio Silano, Claudia Bolognesi, Laurence Castle, Kevin Chipman, et al.. Safety evaluation of the food enzyme aqualysin 1 from a genetically modified Bacillus subtilis (strain LMGS 25520). EFSA Journal, 2018, 16 (5), 20 p. ⟨10.2903/j.efsa.2018.5170⟩. ⟨hal-02618063⟩