Safety evaluation of the food enzyme pullulanase from Pullulanibacillus naganoensis strain AE‐PL

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 , Magdalena Andryszkiewicz , Margarita Aguilera‐gomez , Natalia Kovalkovicova , Yi Liu , Karl‐heinz Engel

1 ToxAlim - ToxAlim

The food enzyme considered in this opinion is a pullulanase (pullulan 6-alpha-glucanohydrolase; EC 3.2.1.41) produced with a non-genetically modified Pullulanibacillus naganoensis (strain AE-PL) by Amano Enzyme Inc. (Japan). The pullulanase food enzyme is intended to be used in starch processing for the production of glucose syrups. Since residual amounts of total organic solid (TOS) in glucose syrups are removed by filtration and purification during starch processing, dietary exposure assessment was not performed. Genotoxicity tests made with the food enzyme indicated no genotoxic potential. A repeated dose 90-day oral toxicity study in rodents, carried out with the food enzyme, showed minor effects that were considered to be of no biological relevance. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens and no match was found. The Panel considered that there are no indications for food allergic reactions to dietary intake of this food enzyme. Based on the removal of residual amounts of TOS from glucose syrups, consumer exposure is not expected. In addition, the safety of the manufacturing process, the compositional and biochemical data lead the Panel to conclude that the food enzyme pullulanase from P. naganoensis (strain AE-PL) does not give rise to safety concerns under the intended conditions of use.

Mots clés: food enzyme; pullulanase; alpha-dextrin endo-1; 6-alpha-glucosidase; pullulan alpha-1-6-glucanohydrolase

Mots clés: Pullulanibacillus naganoensis

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 pullulanase from Pullulanibacillus naganoensis strain AE‐PL. EFSA Journal, 2017, 15 (10), 11 p. ⟨10.2903/j.efsa.2017.5009⟩. ⟨hal-02617597⟩