經(jīng)過評估,專家小組認(rèn)為,在預(yù)期的使用條件下,不能排除飲食暴露引起過敏反應(yīng)的風(fēng)險,但這種情況發(fā)生的可能性很低。根據(jù)所提供的數(shù)據(jù),評估小組得出結(jié)論,這種食品酶在預(yù)期使用條件下不會引起安全問題。部分原文報道如下:
The food enzyme β-galactosidase (β-d-galactoside galactohydrolase; EC 3.2.1.23) is produced with the non-genetically modified Kluyveromyces lactis strain LAC-01 by Nagase (Europa) GmbH. The production strain meets the requirements for the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in two food manufacturing processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 2.133 mg TOS/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concern arising from the food enzyme manufacturing process, toxicity tests were considered unnecessary by the Panel. A search for the homology of the amino acid sequence of the β-galactosidase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but the likelihood is low. 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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