Dataset Information

Safety evaluation of the food enzyme ?-amylase obtained from soybean (Glycine max).

ABSTRACT: The food enzyme considered in this opinion is a ?-amylase (EC 3.2.1.2) from soybean submitted by Nagase (Europa) GmbH. This ?-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 Conservative average infant formula consumption, as reported in the EFSA Draft Guidance on risk assessment of substances present in food intended for infants below 16 weeks of age, was used to estimate the exposure to a fraction of soybean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 ?-amylase was evaluated by searching for similarity of the amino acid sequence to those of known allergens, and no match was found. The ?-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.

SUBMITTER: EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

PROVIDER: S-EPMC7009919 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Safety evaluation of the food enzyme β-amylase obtained from soybean (<i>Glycine max</i>).

Silano Vittorio V Bolognesi Claudia C Castle Laurence L Cravedi Jean-Pierre JP Fowler Paul P Franz Roland R Grob Konrad K Gürtler Rainer R Husøy Trine T Kärenlampi Sirpa S Mennes Wim W Milana Maria Rosaria MR Penninks André A Smith Andrew A Tavares Poças Maria de Fátima MF Tlustos Christina C Wölfle Detlef D Zorn Holger H Zugravu Corina-Aurelia CA Chesson Andrew A Glandorf Boet B Herman Lieve L Jany Klaus-Dieter KD Marcon Francesca F Želježić Davor D Arcella Davide D Divéki Zoltán Z Liu Yi Y Nielsen Kim René Rygaard KRR Engel Karl-Heinz KH

EFSA journal. European Food Safety Authority 20170510 5

The food enzyme considered in this opinion is a β-amylase (EC 3.2.1.2) from soybean 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 cons ...[more]

PMID: 32625476

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Project description:The food enzyme considered in this opinion is a 4-?-d-glucan maltohydrolase (EC 3.2.1.2) obtained from grain of barley (Hordeum vulgare), by the companies Genencor International B.V. and Senson Oy. This ?-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 and the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. Considering the potential for allergenicity, the gluten content of the food enzyme was below the detection limit of the analytical method, which is well below the level of 20 mg/kg for 'gluten-free' products. The amino acid sequence of the ?-amylase was compared to those of known allergens and no match was found. The food enzyme ?-amylase from barley is an occupational respiratory allergen and may contain low levels of other allergenic barley proteins that may trigger adverse reactions upon oral challenges in individuals with an oral sensitisation to cereals. The Panel considers that dietary exposure to the food enzyme ?-amylase from barley may result in incidental cases of food allergic reactions.

Dataset Information

Safety evaluation of the food enzyme ?-amylase obtained from soybean (Glycine max).

Publications

Safety evaluation of the food enzyme β-amylase obtained from soybean (<i>Glycine max</i>).

Similar Datasets

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