Safety evaluation of the food enzyme β-amylase obtained from barley (Hordeum vulgare)
The food enzyme considered in this opinion is a 4-α-d-glucan maltohydrolase (EC 220.127.116.11) 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.
The full opinion will be published in accordance with Article 5 of Regulation (EC) No 1331/2008 once the decision on confidentiality, in line with Article 12(3) of the Regulation, will be received from the European Commission. The following information has been provided under the confidentiality framework and has been redacted awaiting the decision of the Commission: yield factor of the food enzyme, analytical data on gluten content.