据了解,这种食品酶是由非转基因琉球曲霉菌株GSP-4-404生产的,旨在用于8种食品生产过程。
经过评估,专家小组认为,在预期的使用条件下,不能排除通过饮食接触引起过敏反应的风险。根据所提供的数据,小组得出结论,该食品酶在预期的使用条件下不会引起安全问题。部分原文报道如下:
The food enzyme containing endo-polygalacturonase (1,4-α-d-galacturonan glycanohydrolase; EC 3.2.1.15) and pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) activities is produced with the non-genetically modified Aspergillus luchuensis strain GSP-4-404 by Shin Nihon Chemical Co., Ltd. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in eight food manufacturing processes. Since residual amounts of food enzyme–total organic solids (TOS) are removed in one process, dietary exposure was calculated for the remaining seven food manufacturing processes. It was estimated to be up to 0.270 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1080 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 4000. A search for the homology of the two amino acid sequences to known allergens was made and matches with 14 respiratory allergens were found. The Panel considered that a 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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