GRAS Notice (GRN) No. 831 https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory DEC 7 2018 Solutions Consuftin3 OFFICE OF FOOD ADDITIVE SAFETY Catherine Adams Hutt, PhD, RD 4568 Elm Bottom Circle Aubrey, TX 76227
[email protected] 630-605-3022 December 3, 2018 Dr. Dennis M. Keefe Director, Office of Food Additive Safety HFS-200 U.S. Food and Drug Administration 5100 Paint Branch Parkway College Park, MD 20740-3835 Dear Dr. Keefe, In accordance with the FDA regulations governing GRAS status of food substances, 21 CFR §170.3 and §170.30, and the proposed regulations for GRAS notifications, 62 FR 18938 (17 April 1997), I am submitting this GRAS Notification as agent on behalf of Deerland Probiotics and Enzymes. We have determined that the Bacillus subtilis strain named DEl 11 is generally recognized as safe (GRAS), through scientific procedures including review of published scientific literature, and based on its common use in food. The Bacillus subtilis strain named DE 111 is virtually identical to that in the common Asian food natto, which is derived by fermentation of Bacillus subtilis. The probiotic bacteria strain has been fully researched and shown to be safe. Scientific literature includes acute and sub-acute testing in animals. Furthermore, testing of Bacillus subtilis DEl 11 has proven to have no toxic effects, including no cytotoxicity and free of enterotoxins; no antibiotic resistance or other adverse effects. Literature also includes results of research conducted with infants, children, and elderly with no adverse effects; and three clinical trials performed by Deerland to prove efficacy have confirmed that Bacillus subtilis DE 111 is safe with no adverse health effects reported.