Safety evaluation of the food enzyme β-amylase obtained from barley (Hordeum vulgare)

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 Hermann, Klaus-Dieter Jany, Francesca Marcon, Davor Želježić, Davide Arcella, Yi Liu, Kim René Rygaard Nielsen, Karl-Heinz Engel

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The food enzyme considered in this opinion is a 4-α-d-glucan maltohydrolase (EC obtained from grain of barley (Hordeum vulgare), by the companies Genencor International B.V. and Senson Oy. This β-amylase is intended to be used in several food-manufacturing processes: baking and brewing processes, distilled alcohol production, and starch processing for the production of glucose syrups. The compositional data provided for the food enzyme were considered sufficient. The manufacturing process did not raise safety concerns. 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 individual data from the EFSA Comprehensive European Food Consumption Database. This exposure estimate is similar to or lower than the exposure to a fraction of barley comparable to the food enzyme–TOS, resulting from the consumption of barley-derived foods. As the food enzyme is derived from edible parts of barley, in line with the requirements of the guidance document on food enzyme assessment, the Panel accepted that there was no need for the provision of toxicological data for this food enzyme. Barley is known as a gluten-containing cereal; however, the gluten content in the food enzyme was found to be below the detection limit of the applied analytical method and well below the threshold value of 20 mg/kg for ‘gluten-free’ products. Furthermore, the potential allergenicity was evaluated by searching for similarity between the amino acid sequence of β-amylase and the sequences of known food allergens; no match was found. Based on the origin of the food enzyme from edible parts of barley, the enzyme-manufacturing process, the compositional and biochemical data provided, the allergenicity and dietary exposure assessment, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
Original languageEnglish
Specialist publicationEFSA Journal
PublisherEuropean Food Safety Authority (EFSA)
Publication statusPublished - May 2017


  • food enzyme
  • β-amylase
  • 4-α–d-glucan maltohydrolase
  • EC
  • Hordeum vulgare
  • barley


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