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

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 Conservative average infant formula consumption, as reported in the EFSA Draft Guidance on risk assessment of substances present in food intended for infants below 16 weeks of age, was used to estimate the exposure to a fraction of soybean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.