2024年7月4日，歐盟食品安全局就一種食品酶枯草桿菌蛋白酶（subtilisin）的安全性評價發(fā)布意見。
據了解，這種食品酶是由非轉基因副地衣芽孢桿菌菌株AP-01生產的，旨在用于4種食品生產過程。
經過評估，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，特別是對甜瓜或石榴過敏的人，但不會超過食用甜瓜或石榴的風險。根據所提供的數據，專家小組無法排除桿菌肽(一種重要的醫(yī)學抗菌劑)的存在，因此無法確定這種食品酶的安全性。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 paralicheniformis strain AP-01 by Nagase (Europa) GmbH. It was considered free from viable cells of the production organism. The food enzyme is intended to be used in five food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in one process, dietary exposure was calculated only for the remaining four food manufacturing processes. It was estimated to be up to 0.875 mg TOS/kg body weight per day in European populations. The production strain of the food enzyme has the capacity to produce bacitracin and thus failed to meet the requirements of the Qualified Presumption of Safety approach. Bacitracin was detected in the industrial fermentation medium but not in the food enzyme itself. However, the limit of detection of the analytical method used for bacitracin was not sufficient to exclude the possible presence of bacitracin at a level representing a risk for the development of antimicrobial resistant bacteria. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and twenty-eight matches with respiratory allergens, one match with a contact allergen and two matches with food allergens (melon and pomegranate) were found. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to melon or pomegranate, cannot be excluded, but would not exceed the risk of consuming melon or pomegranate. based on the data provided, the Panel could not exclude the presence of bacitracin, a medically important antimicrobial, and consequently the safety of this food enzyme could not be established.
據了解，這種食品酶是由非轉基因副地衣芽孢桿菌菌株AP-01生產的，旨在用于4種食品生產過程。
經過評估，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，特別是對甜瓜或石榴過敏的人，但不會超過食用甜瓜或石榴的風險。根據所提供的數據，專家小組無法排除桿菌肽(一種重要的醫(yī)學抗菌劑)的存在，因此無法確定這種食品酶的安全性。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 paralicheniformis strain AP-01 by Nagase (Europa) GmbH. It was considered free from viable cells of the production organism. The food enzyme is intended to be used in five food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in one process, dietary exposure was calculated only for the remaining four food manufacturing processes. It was estimated to be up to 0.875 mg TOS/kg body weight per day in European populations. The production strain of the food enzyme has the capacity to produce bacitracin and thus failed to meet the requirements of the Qualified Presumption of Safety approach. Bacitracin was detected in the industrial fermentation medium but not in the food enzyme itself. However, the limit of detection of the analytical method used for bacitracin was not sufficient to exclude the possible presence of bacitracin at a level representing a risk for the development of antimicrobial resistant bacteria. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and twenty-eight matches with respiratory allergens, one match with a contact allergen and two matches with food allergens (melon and pomegranate) were found. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to melon or pomegranate, cannot be excluded, but would not exceed the risk of consuming melon or pomegranate. based on the data provided, the Panel could not exclude the presence of bacitracin, a medically important antimicrobial, and consequently the safety of this food enzyme could not be established.
