2023年7月12日，歐盟食品安全局就一種食品酶纖維素酶（cellulase）的安全性評價(jià)發(fā)布意見。
據(jù)了解，這種食品酶是由非轉(zhuǎn)基因黑曲霉菌株294生產(chǎn)的，旨在用于八種食品制造過程：烘焙工藝、谷物加工、釀造工藝、生產(chǎn)淀粉和谷蛋白的谷物處理、果汁生產(chǎn)中的水果和蔬菜加工、果汁以外產(chǎn)品的水果和蔬菜加工、蒸餾酒精生產(chǎn)和葡萄酒及葡萄酒醋的生產(chǎn)。
經(jīng)過評估，專家小組認(rèn)為，在預(yù)期的使用條件下（蒸餾酒精生產(chǎn)除外），不能排除飲食暴露引起過敏反應(yīng)的風(fēng)險(xiǎn)，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隱患。部分原文報(bào)道如下：
The food enzyme cellulase (4-(1,3;1,4)-β-d-glucan-4-glucanohydrolase; EC 3.1.2.4) is produced with the non-genetically modified Aspergillus niger strain 294 by Kerry Ingredients & Flavours Ltd. The food enzyme is considered free from viable cells of the production organism. The enzyme is intended to be used in eight food manufacturing processes: baking processes, cereal-based processes, brewing processes, grain treatment for the production of starch and gluten fractions, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, distilled alcohol production and wine and wine vinegar production. Since residual amounts of total organic solids (TOS) are removed during distilled alcohol production and grain treatment for the production of starch and gluten fractions, dietary exposure was only calculated for the remaining six food manufacturing processes. It was estimated to be up to 5.706 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 794 mg TOS/kg bw per day, the highest dose tested. The calculated margin of exposure for each age group was 184 (infants), 146 (toddlers), 139 (children), 219 (adolescents), 305 (adults) and 441 (the elderly). A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and four matches were found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production), the risk of allergic reactions by 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 for adolescents, adults and the elderly.
據(jù)了解，這種食品酶是由非轉(zhuǎn)基因黑曲霉菌株294生產(chǎn)的，旨在用于八種食品制造過程：烘焙工藝、谷物加工、釀造工藝、生產(chǎn)淀粉和谷蛋白的谷物處理、果汁生產(chǎn)中的水果和蔬菜加工、果汁以外產(chǎn)品的水果和蔬菜加工、蒸餾酒精生產(chǎn)和葡萄酒及葡萄酒醋的生產(chǎn)。
經(jīng)過評估，專家小組認(rèn)為，在預(yù)期的使用條件下（蒸餾酒精生產(chǎn)除外），不能排除飲食暴露引起過敏反應(yīng)的風(fēng)險(xiǎn)，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隱患。部分原文報(bào)道如下：
The food enzyme cellulase (4-(1,3;1,4)-β-d-glucan-4-glucanohydrolase; EC 3.1.2.4) is produced with the non-genetically modified Aspergillus niger strain 294 by Kerry Ingredients & Flavours Ltd. The food enzyme is considered free from viable cells of the production organism. The enzyme is intended to be used in eight food manufacturing processes: baking processes, cereal-based processes, brewing processes, grain treatment for the production of starch and gluten fractions, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, distilled alcohol production and wine and wine vinegar production. Since residual amounts of total organic solids (TOS) are removed during distilled alcohol production and grain treatment for the production of starch and gluten fractions, dietary exposure was only calculated for the remaining six food manufacturing processes. It was estimated to be up to 5.706 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 794 mg TOS/kg bw per day, the highest dose tested. The calculated margin of exposure for each age group was 184 (infants), 146 (toddlers), 139 (children), 219 (adolescents), 305 (adults) and 441 (the elderly). A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and four matches were found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production), the risk of allergic reactions by 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 for adolescents, adults and the elderly.
