重组枯草芽孢杆菌表达的D-阿洛酮糖-3-差向异构酶安全性研究

Study on the Safety of Recombinant D-allulose-3-epimerase Expressed by Bacillus Subtilis

通过系统评估重组枯草芽孢杆菌表达D-阿洛酮糖-3-差向异构酶的安全性,为D-阿洛酮糖-3-差向异构酶在食品中的应用提供科学依据。依据现行《食品添加剂新品种管理办法》的规定,对D-阿洛酮糖-3-差向异构酶开展卫生学检验(重金属、微生物)、毒理学试验(包括急性经口毒性试验、3项遗传毒性试验、90 d经口毒性试验和致畸试验)等。重金属和微生物均符合我国食品安全国家标准的规定。D-阿洛酮糖-3-差向异构酶急性经口毒性试验表明:该物质属实际无毒级;3项遗传毒性试验结果均为阴性;90 d经口毒性试验未观察到有害作用剂量为19.6 g/(kg·bw·d),致畸试验结果显示试验剂量下D-阿洛酮糖-3-差向异构酶对SD大鼠无致畸作用。3批次D-阿洛酮糖-3-差向异构酶样品中均未检出枯草芽孢杆菌活菌。D-阿洛酮糖-3-差向异构酶作为食品添加剂新品种对人体健康造成的潜在风险较低。

Systematically evaluate the safety of recombinant Bacillus subtilis expressing D-allulose-3-epimerase,and provide scientific basis for the application of D-allulose-3-epimerase in food.According to the provisions of the current Measures for the Administration of New Varieties of Food Additives,hygienic tests(heavy metals,microorganisms),toxicological tests(including acute oral toxicity test,three Genotoxicity tests,90 d oral toxicity test and teratogenicity test),etc.are carried out for D-allulose-3-epimerase.Both heavy metals and microorganisms comply with the provisions of China’s national food safety standards.The acute oral toxicity test of D-allulose-3-epimerase shows that the substance is actually non-toxic.The results of three genotoxicity tests are negative.In the 90 d oral toxicity test,no harmful effect is observed at a dose of 19.6 g/(kg·bw·d),and the teratogenic test results show that D-allulose-3-epimerase has no teratogenic effect on SD rats at the test dose.No viable Bacillus subtilis is detected in three batches of D-allulose-3-epimerase samples.As a new food additive,D-allulose-3 epimerase has low potential risk to human health.