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