Safety evaluation of a β-amylase food enzyme obtained from wheat (Triticum spp.)
Note: 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: steps and control points during the processing, process chemicals.
The food enzyme considered in this opinion is a β-amylase (EC 18.104.22.168), obtained from the grain of wheat (Triticum spp.) by Roquette (France). The β-amylase is intended to be used in starch processing for production of glucose syrups containing maltose to be used as a food ingredient. Since the presence of residual amounts of total organic solids (TOS) in glucose syrups after filtration and purification during starch processing is negligible, no dietary exposure was calculated. As the food enzyme is derived from edible parts of wheat, no toxicological tests are required. Wheat is known as a gluten-containing cereal. However, the gluten content of the food enzyme was shown to be below the limit of quantification 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 the β-amylase and the sequences of known food allergens; no match was found. Although β-amylase from wheat is described as a potential occupational respiratory allergen, and oral wheat challenges in wheat allergic patients may result in clinical symptoms, the enzyme and the low levels of other wheat proteins will be removed from the final food ingredients through a downstream purification process. Based on the origin of the food enzyme from edible parts of grain, the manufacturing process, and the compositional and biochemical data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.