Dataset Information

Safety evaluation of a ?-amylase food enzyme obtained from wheat (Triticum spp.).

ABSTRACT: The food enzyme considered in this opinion is a ?-amylase (EC 3.2.1.2), obtained from the grain of wheat (Triticum spp.) by Roquette (France). The ?-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 ?-amylase and the sequences of known food allergens; no match was found. Although ?-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.

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

PROVIDER: S-EPMC7009837 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Publications

Safety evaluation of a β-amylase food enzyme obtained from wheat (<i>Triticum</i> spp.).

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 de Fátima Tavares Poças Maria M Tlustos Christina C Wölfle Detlef D Zorn Holger H Zugravu Corina-Aurelia CA Chesson Andrew A Glandorf Boet B Hermann Lieve L Jany Klaus-Dieter KD Marcon Francesca F Želježic Davor D Andryszkiewicz Magdalena M Liu Yi Y 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), obtained from the grain of wheat (<i>Triticum</i> 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 foo ...[more]

PMID: 32625473

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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 a ?-amylase food enzyme obtained from wheat (Triticum spp.).

Publications

Safety evaluation of a β-amylase food enzyme obtained from wheat (<i>Triticum</i> spp.).

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