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

Research output: Contribution to specialist publicationArticle

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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 languageEnglish
Pagese04895
Volume15
No.8
Specialist publicationEFSA Journal
PublisherEuropean Food Safety Authority (EFSA)
DOIs
Publication statusPublished - Aug 2017

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Food Safety
Bacillus subtilis
Food
Enzymes
Starch
Microbial Genetics
Biochemical Phenomena
Mutagenicity Tests
Glucose
Denmark
Allergens
Toxicology
Amino Acid Sequence
Rodentia
Hypersensitivity
Safety
pullulanase

Keywords

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

Cite this

EFSA Panel on Food Contact Materials Enzymes, F. A. P. A. CEF., Silano, V., Bolognesi, C., Castle, L., Cravedi, J-P., Fowler, P., ... 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

Safety evaluation of the food enzyme pullulanase from genetically modified Bacillus subtilis strain NZYM-AK. / EFSA Panel on Food Contact Materials Enzymes, Flavourings and Processing Aids (CEF); Silano, Vittorio; Bolognesi, Claudia; Castle, Laurence; Cravedi, Jean-Pierre; Fowler, Paul; Franz, Roland; Grob, Konrad; Gürtler, Rainer; Husøy, Trine; Kärenlampi, Sirpa; Mennes, Wim; Milana, Maria Rosaria; Penninks, André; Smith, Andrew; Tavares Poças, Maria de Fátima; Tlustos, Christina; Wölfle, Detlef; Zorn, Holger; Zugravu, Corina-Aurelia; Chesson, Andrew; Glandorf, Boet; Herman, Lieve; Jany, Klaus-Dieter; Marcon, Francesca; Želježic, Davor; Aguilera-Gómez, Margarita; Kovalkovičová, Natália; Maia, Joaquim; Engel, Karl-Heinz.

In: EFSA Journal, Vol. 15, No. 8, 08.2017, p. e04895.

Research output: Contribution to specialist publicationArticle

EFSA Panel on Food Contact Materials Enzymes, FAPACEF, 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
EFSA Panel on Food Contact Materials Enzymes FAPACEF, Silano V, Bolognesi C, Castle L, Cravedi J-P, Fowler P et al. Safety evaluation of the food enzyme pullulanase from genetically modified Bacillus subtilis strain NZYM-AK. EFSA Journal. 2017 Aug;15(8):e04895. https://doi.org/10.2903/j.efsa.2017.4895
EFSA Panel on Food Contact Materials Enzymes, Flavourings and Processing Aids (CEF) ; Silano, Vittorio ; Bolognesi, Claudia ; Castle, Laurence ; Cravedi, Jean-Pierre ; Fowler, Paul ; Franz, Roland ; Grob, Konrad ; Gürtler, Rainer ; Husøy, Trine ; Kärenlampi, Sirpa ; Mennes, Wim ; Milana, Maria Rosaria ; Penninks, André ; Smith, Andrew ; Tavares Poças, Maria de Fátima ; Tlustos, Christina ; Wölfle, Detlef ; Zorn, Holger ; Zugravu, Corina-Aurelia ; Chesson, Andrew ; Glandorf, Boet ; Herman, Lieve ; Jany, Klaus-Dieter ; Marcon, Francesca ; Želježic, Davor ; Aguilera-Gómez, Margarita ; Kovalkovičová, Natália ; Maia, Joaquim ; Engel, Karl-Heinz. / Safety evaluation of the food enzyme pullulanase from genetically modified Bacillus subtilis strain NZYM-AK. In: EFSA Journal. 2017 ; Vol. 15, No. 8. pp. e04895.
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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.",
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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

PY - 2017/8

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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.

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KW - EC 3.2.1.41

KW - Bacillus subtilis

KW - genetically modified microorganism

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DO - 10.2903/j.efsa.2017.4895

M3 - Article

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SP - e04895

JO - EFSA Journal

JF - EFSA Journal

SN - 1831-4732

PB - European Food Safety Authority (EFSA)

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