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

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

doi:10.2903/j.efsa.2017.4895

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

Flavourings and Processing Aids (CEF) EFSA Panel on Food Contact Materials Enzymes, 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 ZugravuAndrew Chesson, Boet Glandorf, Lieve Herman, Klaus-Dieter Jany, Francesca Marcon, Davor Želježic, Margarita Aguilera-Gómez, Natália Kovalkovičová, Joaquim Maia, Karl-Heinz Engel

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Abstract

The food enzyme considered in this opinion is a pullulanase (pullulan 6-α-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 Panel considers 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 Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Original language	English
Pages	e04895
Volume	15
No.	8
Specialist publication	EFSA Journal
Publisher	European Food Safety Authority (EFSA)
DOIs	https://doi.org/10.2903/j.efsa.2017.4895
Publication status	Published - Aug 2017

Keywords

food enzyme
pullulanase
pullulan 6-α-glucanohydrolase
EC 3.2.1.41
Bacillus subtilis
genetically modified microorganism

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10.2903/j.efsa.2017.4895Licence: CC BY-ND

Safety evaluation of the food enzyme pullulanase from genetically modified Bacillus subtilis strain NZYM-AK
© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. © 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/
Final published version, 781 KBLicence: CC BY-ND

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EFSA Panel on Food Contact Materials Enzymes, F. A. P. A., Silano, V., Bolognesi, C., Castle, L., Cravedi, J.-P., Fowler, P., Franz, R., Grob, K., Gürtler, R., Husøy, T., Kärenlampi, S., Mennes, W., Milana, M. R., Penninks, A., Smith, A., Tavares Poças, M. D. F., Tlustos, C., Wölfle, D., Zorn, H., ... Engel, K.-H. (2017). Safety evaluation of the food enzyme pullulanase from genetically modified Bacillus subtilis strain NZYM-AK. EFSA Journal, 15(8), e04895. https://doi.org/10.2903/j.efsa.2017.4895

EFSA Panel on Food Contact Materials Enzymes, FAPA, Silano, V, Bolognesi, C, Castle, L, Cravedi, J-P, Fowler, P, Franz, R, Grob, K, Gürtler, R, Husøy, T, Kärenlampi, S, Mennes, W, Milana, MR, Penninks, A, Smith, A, Tavares Poças, MDF, Tlustos, C, Wölfle, D, Zorn, H, Zugravu, C-A, Chesson, A, Glandorf, B, Herman, L, Jany, K-D, Marcon, F, Želježic, D, Aguilera-Gómez, M, Kovalkovičová, N, Maia, J & Engel, K-H 2017, 'Safety evaluation of the food enzyme pullulanase from genetically modified Bacillus subtilis strain NZYM-AK' EFSA Journal, vol. 15, no. 8, pp. e04895. https://doi.org/10.2903/j.efsa.2017.4895

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

abstract = "The food enzyme considered in this opinion is a pullulanase (pullulan 6-α-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 Panel considers 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 Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.",

keywords = "food enzyme, pullulanase, pullulan 6-α-glucanohydrolase, EC 3.2.1.41, Bacillus subtilis, genetically modified microorganism",

author = "{EFSA Panel on Food Contact Materials Enzymes}, {Flavourings and Processing Aids (CEF)} and Vittorio Silano and Claudia Bolognesi and Laurence Castle and Jean-Pierre Cravedi and Paul Fowler and Roland Franz and Konrad Grob and Rainer G{\"u}rtler and Trine Hus{\o}y and Sirpa K{\"a}renlampi and Wim Mennes and Milana, {Maria Rosaria} and Andr{\'e} Penninks and Andrew Smith and {Tavares Po{\c c}as}, {Maria de F{\'a}tima} and Christina Tlustos and Detlef W{\"o}lfle and Holger Zorn and Corina-Aurelia Zugravu and Andrew Chesson and Boet Glandorf and Lieve Herman and Klaus-Dieter Jany and Francesca Marcon and Davor {\v Z}elje{\v z}ic and Margarita Aguilera-G{\'o}mez and Nat{\'a}lia Kovalkovi{\v c}ov{\'a} and Joaquim Maia and Karl-Heinz Engel",

year = "2017",

month = aug,

doi = "10.2903/j.efsa.2017.4895",

language = "English",

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

AU - Silano, Vittorio

AU - Bolognesi, Claudia

AU - Castle, Laurence

AU - Cravedi, Jean-Pierre

AU - Fowler, Paul

AU - Franz, Roland

AU - Grob, Konrad

AU - Gürtler, Rainer

AU - Husøy, Trine

AU - Kärenlampi, Sirpa

AU - Mennes, Wim

AU - Milana, Maria Rosaria

AU - Penninks, André

AU - Smith, Andrew

AU - Tavares Poças, Maria de Fátima

AU - Tlustos, Christina

AU - Wölfle, Detlef

AU - Zorn, Holger

AU - Zugravu, Corina-Aurelia

AU - Chesson, Andrew

AU - Glandorf, Boet

AU - Herman, Lieve

AU - Jany, Klaus-Dieter

AU - Marcon, Francesca

AU - Želježic, Davor

AU - Aguilera-Gómez, Margarita

AU - Kovalkovičová, Natália

AU - Maia, Joaquim

AU - Engel, Karl-Heinz

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N2 - The food enzyme considered in this opinion is a pullulanase (pullulan 6-α-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 Panel considers 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 Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.

AB - The food enzyme considered in this opinion is a pullulanase (pullulan 6-α-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 Panel considers 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 Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.

KW - food enzyme

KW - pullulanase

KW - pullulan 6-α-glucanohydrolase

KW - EC 3.2.1.41

KW - Bacillus subtilis

KW - genetically modified microorganism

U2 - 10.2903/j.efsa.2017.4895

DO - 10.2903/j.efsa.2017.4895

M3 - Article

SN - 1831-4732

VL - 15

SP - e04895

JO - EFSA Journal

JF - EFSA Journal

PB - European Food Safety Authority (EFSA)

ER -

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

Abstract

Keywords

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