Aguilera-Gómez, Margarita

Bolognesi, Claudia

Castle, Laurence

Chesson, Andrew

Cravedi, Jean-Pierre

EFSA Panel on Food Contact Materials Enzymes, Flavourings and Processing Aids (CEF)

Engel, Karl-Heinz

Fowler, Paul

Franz, Roland

Glandorf, Boet

Grob, Konrad

Gürtler, Rainer

Herman, Lieve

Husøy, Trine

Jany, Klaus-Dieter

Kovalkovičová, Natália

Kärenlampi, Sirpa

Maia, Joaquim

Marcon, Francesca

Mennes, Wim

Milana, Maria Rosaria

Penninks, André

Silano, Vittorio

Smith, Andrew

Tavares Poças, Maria de Fátima

Tlustos, Christina

Wölfle, Detlef

Zorn, Holger

Zugravu, Corina-Aurelia

Želježic, Davor

EFSA Journal

English

International audienceThe food enzyme considered in this opinion is a pullulanase (pullulan 6--glucanohydrolase; EC 3.2.1.41), produced with the genetically modified Bacillus subtilis strain NZYM-AK by Novozymes A/S (Denmark). The pullulanase food enzyme is intended to be used in starch processing for the production of glucose syrups. Since the residual amounts of total organic solids (TOS) in glucose syrups after filtration and purification during starch processing were considered negligible, no dietary exposure was calculated. Genotoxicity tests made with the food enzyme indicated no genotoxic concern. A repeated dose 90-day oral toxicity study in rodents, carried out with a pullulanase produced with a predecessor strain, showed no concern with respect to systemic toxicity. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no match was found. The Panelconsiders that there are no indications for allergic reactions. Based on the microbial source, genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the findings in the toxicological studies and allergenicity assessment, the Panelconcludes that this food enzyme does not give rise to safety concerns under the intended conditions of use

Cravedi, Jean Pierre,

Penninks, Andre

Zugravu, Corina‐Aurelia

Jany, Klaus‐Dieter

Aguilera‐Gomez, Margarita

Kovalkovicova, Natalia

Engel, Karl‐Heinz

HAL Descartes

Safety evaluation of the food enzyme pullulanase from genetically modified Bacillus subtilis strain NZYM‐AK

Aberdeen University Research

Safety evaluation of the food enzyme pullulanase from genetically modified Bacillus subtilis strain NZYM-AK

null null

Vittorio Silano

Claudia Bolognesi

Laurence Castle

Jean‐Pierre Cravedi

Paul Fowler

Roland Franz

Konrad Grob

Rainer Gürtler

Trine Husøy

Sirpa Kärenlampi

Wim Mennes

Maria Rosaria Milana

André Penninks

Andrew Smith

Maria de Fátima Tavares Poças

Christina Tlustos

Detlef Wölfle

Holger Zorn

Corina‐Aurelia Zugravu

Andrew Chesson

Boet Glandorf

Lieve Herman

Klaus‐Dieter Jany

Francesca Marcon

Davor Želježic

Margarita Aguilera‐Gómez

Natália Kovalkovičová

Joaquim Maia

Karl‐Heinz Engel

Crossref

Cravedi, Jean Pierre, J. P.

Zugravu, Corina‐aurelia

Jany, Klaus‐dieter

Aguilera‐gomez, Margarita

Engel, Karl‐heinz

HAL ENVT (Ecole Nationale Vétérinaire de Toulouse)

HAL: Hyper Article en Ligne

HAL Université de Toulouse, et Toulouse INP

https://hal.inrae.fr/hal-02617594/document

Safety evaluation of the food enzyme pullulanase from genetically modified Bacillus subtilis strain NZYM-AK

Abstract

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