2023年11月23日，歐盟食品安全局就一種枯草桿菌蛋白酶（subtilisin）的安全性評價發(fā)布意見。
據(jù)了解，這種食品酶是由非轉(zhuǎn)基因地衣芽孢桿菌菌株NZYM-CX生產(chǎn)的，旨在用于八種食品生產(chǎn)過程:加工谷物和其他谷物以生產(chǎn)釀造產(chǎn)品；加工乳制品以生產(chǎn)改良的乳蛋白和調(diào)味制劑；加工源自植物和真菌的產(chǎn)品，以生產(chǎn)基于植物的牛奶和奶制品類似物、蛋白質(zhì)水解產(chǎn)物和來自藻類的食用油；加工肉類和魚類產(chǎn)品以生產(chǎn)蛋白質(zhì)水解產(chǎn)物；酵母和酵母產(chǎn)品加工。
經(jīng)過評估，專家小組認(rèn)為，在預(yù)期的使用條件下，不能排除飲食暴露引起過敏反應(yīng)的風(fēng)險，特別是對甜瓜或石榴過敏的個體，但不會超過食用這些食品的風(fēng)險。根據(jù)所提供的數(shù)據(jù)，評估小組得出結(jié)論，這種食品酶在預(yù)期使用條件下不會引起安全問題。部分原文報道如下：
The food enzyme subtilisin (EC 3.4.21.62) is produced with the non-genetically modified Bacillus licheniformis strain NZYM-CX by Novozymes A/S. The production strain met the requirements for the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in eight food manufacturing processes: processing of cereals and other grains for the production of brewed products; processing of dairy products for the production of modified milk proteins and flavouring preparations; processing of plant- and fungal-derived products for the production of plant-based analogues of milk and milk products, protein hydrolysates and edible oils from algae; processing of meat and fish products for the production of protein hydrolysates; processing of yeast and yeast products. Since residual amounts of total organic solids (TOS) are removed in the production of edible oils from algae, dietary exposure was calculated only for the remaining seven food manufacturing processes. Exposure was estimated to be up to 2.393 mg TOS/kg body weight (bw) per day in European populations. As the production strain qualified for the QPS approach and no issues of concern arose from the production process of the food enzyme, the Panel considered that toxicological studies were unnecessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was performed, and a total of 20 matches were found, 17 to respiratory allergens, two to food allergens (found in muskmelon and pomegranate) and one to a contact allergen. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, especially in individuals sensitised to muskmelon or pomegranate, but would not exceed the risk of consuming these foods. 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.
據(jù)了解，這種食品酶是由非轉(zhuǎn)基因地衣芽孢桿菌菌株NZYM-CX生產(chǎn)的，旨在用于八種食品生產(chǎn)過程:加工谷物和其他谷物以生產(chǎn)釀造產(chǎn)品；加工乳制品以生產(chǎn)改良的乳蛋白和調(diào)味制劑；加工源自植物和真菌的產(chǎn)品，以生產(chǎn)基于植物的牛奶和奶制品類似物、蛋白質(zhì)水解產(chǎn)物和來自藻類的食用油；加工肉類和魚類產(chǎn)品以生產(chǎn)蛋白質(zhì)水解產(chǎn)物；酵母和酵母產(chǎn)品加工。
經(jīng)過評估，專家小組認(rèn)為，在預(yù)期的使用條件下，不能排除飲食暴露引起過敏反應(yīng)的風(fēng)險，特別是對甜瓜或石榴過敏的個體，但不會超過食用這些食品的風(fēng)險。根據(jù)所提供的數(shù)據(jù)，評估小組得出結(jié)論，這種食品酶在預(yù)期使用條件下不會引起安全問題。部分原文報道如下：
The food enzyme subtilisin (EC 3.4.21.62) is produced with the non-genetically modified Bacillus licheniformis strain NZYM-CX by Novozymes A/S. The production strain met the requirements for the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in eight food manufacturing processes: processing of cereals and other grains for the production of brewed products; processing of dairy products for the production of modified milk proteins and flavouring preparations; processing of plant- and fungal-derived products for the production of plant-based analogues of milk and milk products, protein hydrolysates and edible oils from algae; processing of meat and fish products for the production of protein hydrolysates; processing of yeast and yeast products. Since residual amounts of total organic solids (TOS) are removed in the production of edible oils from algae, dietary exposure was calculated only for the remaining seven food manufacturing processes. Exposure was estimated to be up to 2.393 mg TOS/kg body weight (bw) per day in European populations. As the production strain qualified for the QPS approach and no issues of concern arose from the production process of the food enzyme, the Panel considered that toxicological studies were unnecessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was performed, and a total of 20 matches were found, 17 to respiratory allergens, two to food allergens (found in muskmelon and pomegranate) and one to a contact allergen. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, especially in individuals sensitised to muskmelon or pomegranate, but would not exceed the risk of consuming these foods. 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.
