經(jīng)過評估,專家小組認為,在預期的使用條件下,不能排除通過飲食接觸引起過敏反應的風險,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),小組得出結論,該食品酶在預期的使用條件下不會引起安全問題。部分原文報道如下:
The food enzyme ribonuclease P (EC 3.1.26.5) is produced with the non-genetically modified Penicillium citrinum strain AE-RP-4 by Amano Enzyme Inc. It is intended to be used in yeast processing only for the production of yeast extract. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.153 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise safety concerns. 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 (NOAEL) of 134.7 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 880. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure 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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