GRAS Notice (GRN) No. 893 https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory. Tox• Strategi.es Innovative solutions Sound science December 3, 2019 Office of Food Additive Safety (HFS-200) Center for Food Safety and Applied Nutrition Food and Drug Administration 500 I Campus Drive College Park, MD 20740-3835 Subject: GRAS Notification-Allulose Dear Sir: On behalf of Tate & Lyle., ToxStrategies, Inc. (its agent) is submitting, for FDA review, a copy of the GRAS notification as required. The enclosed document provides notice of a claim that the food ingredient, allulose, described in the enclosed notification is exempt from the premarket approval requirement of the Federal Food, Drug, and Cosmetic Act because it has been determined to be generally recognized as safe (GRAS), based on scientific procedures, for addition to food. In addition, non-safety related data and information (marked as confidential; Exhibit 2) are attached to the GRAS notice that are to be shared with the Food Safety Inspection Service (PSIS) of the U.S. Department of Agriculture (USDA). If you have any questions or require additional information, please do not hesitate to contact me at 630-352-0303, or
[email protected]. Sincerely, Donald F. Schmitt, M.P .H. Senior Managing Scientist ~~~~"YJ~(Q) DEC 6 2019 OFFICE OF FOOD ADDITIVE SAFETY ToxStrategies, Inc., 931 W. 75th St., Suite 137, PMB 255, Naperville, IL 60565 Office (630) 352-030 • www.toxstrategies.com GRAS Determination of Allulose for ·.· ;;/. ,; "i· Use as an lngredie-nt in Human Food OCTOBER 11,~2§19 .. ;·~, DEC 6 2019 OFFICE OF FOOD ADDmVE SAFETY Innovative solutions Sound science GRAS Determination of Allulose for Use as an Ingredient in Human Food SUBMITTED BY: Tate & Lyle 5450 Prairie Stone Parkway Hoffman Estates, IL 60192 SUBMITTED TO: U.S.