2024年10月9日，歐盟食品安全局就一種食品酶內(nèi)切-1,3（4）-β-葡聚糖酶（endo-1,3(4)-β-glucanase）的安全性評價發(fā)布意見?！ ?br> 據(jù)了解，這種食品酶是由非轉(zhuǎn)基因Talaromyces versatilis菌株P(guān)F8生產(chǎn)的，旨在用于4種食品生產(chǎn)過程。
經(jīng)過評估，專家小組認(rèn)為，在預(yù)期的使用條件下，不能排除通過飲食接觸引起過敏反應(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)，小組得出結(jié)論，該食品酶在預(yù)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 endo-1,3(4)-β-glucanase (3-(1–3;1–4)-β-d-glucan 3(4)-glucanohydrolase; EC 3.2.1.6) is produced with the non-genetically modified Talaromyces versatilis strain PF8 by Erbslöh Geisenheim AG. The food enzyme was free from viable cells of the production organism. It is intended to be used in four food manufacturing processes. Dietary exposure to the food enzyme–total organic solids (TOS) was calculated to be up to 0.110 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 2229 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 20,264. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and four matches with respiratory or contact allergens were found. The Panel considered that 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.
經(jīng)過評估，專家小組認(rèn)為，在預(yù)期的使用條件下，不能排除通過飲食接觸引起過敏反應(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)，小組得出結(jié)論，該食品酶在預(yù)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 endo-1,3(4)-β-glucanase (3-(1–3;1–4)-β-d-glucan 3(4)-glucanohydrolase; EC 3.2.1.6) is produced with the non-genetically modified Talaromyces versatilis strain PF8 by Erbslöh Geisenheim AG. The food enzyme was free from viable cells of the production organism. It is intended to be used in four food manufacturing processes. Dietary exposure to the food enzyme–total organic solids (TOS) was calculated to be up to 0.110 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 2229 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 20,264. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and four matches with respiratory or contact allergens were found. The Panel considered that 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.
