经过评估,专家小组认为,在预期的使用条件下,不能排除饮食暴露引起过敏反应的风险,但这种可能性被认为很低。根据所提供的数据,评估小组得出结论,这种食品酶在预期使用条件下不会引起安全问题。部分原文报道如下:
The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified microorganism Bacillus amyloliquefaciens strain UN-01 by Nagase (Europa) GmbH. The production strain qualified for the qualified presumption of safety approach and no issues of concern arose from the production process of the food enzyme, therefore, the Panel considered that toxicological studies were unnecessary. It is intended to be used in five food manufacturing processes. Since residual amounts of total organic solids (TOS) are removed during two processes, dietary exposure was calculated only for the remaining three food manufacturing processes. It was estimated to be up to 0.434 mg TOS/kg body weight per day in European populations. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and one match with a respiratory allergen was found. Known sources of food allergens were used in the food enzyme manufacturing process. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded. based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.
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