据了解,这种食品酶是由转基因紫红链霉菌菌株pPDN生产的,旨在用于两种食品生产过程。
经过评估,专家小组认为,在预期的使用条件下,不能排除饮食暴露引起过敏反应的风险,但这种情况发生的可能性很低。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 phospholipase D (phosphatidylcholine phosphatidohydrolase; EC 3.1.4.4) is produced with the genetically modified Streptomyces violaceoruber strain pPDN by Nagase ChemteX. The production strain of the food enzyme contains several antimicrobial resistance genes, of which at least one is acquired. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. 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 0.167 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 808 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 4838. A search for the homology of the amino acid sequence of the phospholipase D 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 that 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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