Safety evaluation of the food enzyme β-amylase obtained from soybean (Glycine max) whey

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 & 11 others Boet Glandorf, Lieve Hermann, Klaus-Dieter Jany, Francesca Marcon, Davor Želježić, Davide Arcella, Zoltán Divéki, Yi Liu, Kim René Rygaard Nielsen, Karl-Heinz Engel, EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

Research output: Contribution to specialist publicationArticle

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Abstract

The food enzyme considered in this opinion is a β-amylase (EC 3.2.1.2) from soybean whey, submitted by Nagase (Europa) GmbH. This β-amylase is intended to be used in the starch processing for maltose syrup production and the manufacture of a Japanese rice cake type. Based on the maximum use levels recommended for the respective food processes, dietary exposure to the food enzyme–total organic solids (TOS) was estimated on the basis of Japanese consumption data. Conservative average infant formula consumption, as reported in the EFSA Draft Guidance on risk assessment of substances present in food intended for infants below 16 weeks of age, was used to estimate the exposure to a fraction of soybean comparable to the food enzyme–TOS, resulting from the consumption of soybean-derived foods. The exposure estimate to the food enzyme–TOS was found to be lower than the comparable fraction from the source material. Potential allergenicity of the β-amylase was evaluated by searching for similarity of the amino acid sequence to those of known allergens, and no match was found. The β-amylase is produced from soybean, which is a known allergenic food. Japanese rice cake, consequently, may contain traces of soybean allergens, which may give rise to safety concerns in soybean-allergic consumers. Based on the origin of the food enzyme from edible parts of soybean, the manufacturing process, the compositional and biochemical data provided and the dietary intake estimates, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use, except that Japanese rice cake produced with this food enzyme may contain traces of soybean allergens.
Original languageEnglish
Pagese04757
Volume15
No.5
Specialist publicationEFSA Journal
PublisherEuropean Food Safety Authority (EFSA)
DOIs
Publication statusPublished - 10 May 2017

Fingerprint

food analysis
whey
amylases
soybeans
rice cakes
enzymes
allergens
manufacturing
beta-N-acetylhexosaminidase
allergenicity
organic foods
beta-amylase
infant foods
dietary exposure
syrups
infant formulas
maltose
risk assessment
food intake
amino acid sequences

Keywords

  • food enzyme
  • β-amylase
  • EC 3.2.1.2
  • Glycine max
  • soybean

Cite this

Silano, V., Bolognesi, C., Castle, L., Cravedi, J-P., Fowler, P., Franz, R., ... EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) (2017). Safety evaluation of the food enzyme β-amylase obtained from soybean (Glycine max) whey. EFSA Journal, 15(5), e04757. https://doi.org/10.2903/j.efsa.2017.4757

Safety evaluation of the food enzyme β-amylase obtained from soybean (Glycine max) whey. / 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; Hermann, Lieve; Jany, Klaus-Dieter; Marcon, Francesca; Želježić, Davor; Arcella, Davide; Divéki, Zoltán; Liu, Yi; Nielsen, Kim René Rygaard; Engel, Karl-Heinz; EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF).

In: EFSA Journal, Vol. 15, No. 5, 10.05.2017, p. e04757.

Research output: Contribution to specialist publicationArticle

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, Hermann, L, Jany, K-D, Marcon, F, Želježić, D, Arcella, D, Divéki, Z, Liu, Y, Nielsen, KRR, Engel, K-H & EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 2017, 'Safety evaluation of the food enzyme β-amylase obtained from soybean (Glycine max) whey' EFSA Journal, vol. 15, no. 5, pp. e04757. https://doi.org/10.2903/j.efsa.2017.4757
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 ; Hermann, Lieve ; Jany, Klaus-Dieter ; Marcon, Francesca ; Želježić, Davor ; Arcella, Davide ; Divéki, Zoltán ; Liu, Yi ; Nielsen, Kim René Rygaard ; Engel, Karl-Heinz ; EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF). / Safety evaluation of the food enzyme β-amylase obtained from soybean (Glycine max) whey. In: EFSA Journal. 2017 ; Vol. 15, No. 5. pp. e04757.
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abstract = "The food enzyme considered in this opinion is a β-amylase (EC 3.2.1.2) from soybean whey, submitted by Nagase (Europa) GmbH. This β-amylase is intended to be used in the starch processing for maltose syrup production and the manufacture of a Japanese rice cake type. Based on the maximum use levels recommended for the respective food processes, dietary exposure to the food enzyme–total organic solids (TOS) was estimated on the basis of Japanese consumption data. Conservative average infant formula consumption, as reported in the EFSA Draft Guidance on risk assessment of substances present in food intended for infants below 16 weeks of age, was used to estimate the exposure to a fraction of soybean comparable to the food enzyme–TOS, resulting from the consumption of soybean-derived foods. The exposure estimate to the food enzyme–TOS was found to be lower than the comparable fraction from the source material. Potential allergenicity of the β-amylase was evaluated by searching for similarity of the amino acid sequence to those of known allergens, and no match was found. The β-amylase is produced from soybean, which is a known allergenic food. Japanese rice cake, consequently, may contain traces of soybean allergens, which may give rise to safety concerns in soybean-allergic consumers. Based on the origin of the food enzyme from edible parts of soybean, the manufacturing process, the compositional and biochemical data provided and the dietary intake estimates, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use, except that Japanese rice cake produced with this food enzyme may contain traces of soybean allergens.",
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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

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AU - Smith, Andrew

AU - Tavares Poças, Maria de Fátima

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AU - Hermann, Lieve

AU - Jany, Klaus-Dieter

AU - Marcon, Francesca

AU - Želježić, Davor

AU - Arcella, Davide

AU - Divéki, Zoltán

AU - Liu, Yi

AU - Nielsen, Kim René Rygaard

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KW - Glycine max

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