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GRAS Notice No.911, Rebaudioside L

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GRAS Notice No.911, Rebaudioside L GRAS Notice (GRN) No. 911 #911 https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory GRASAssociates, LLC 11810 Grand ParkAve GRAS Suite 500 ASSOCIATES LLC North Bethesda. MO 20852 T: 519.341.3667 IF: 888.531.3466 www.gras-associates.com January 30, 2020 Food and Drug Administration Center for Food Safety & Applied Nutrition Office of Food Additive Safety (HFS-200) 5001 Campus Drive College Park, MD 20740 Attention: Dr. Susan Carlson Re: GRAS Notification- Rebaudioside I Dear Dr. Carlson: GRAS Associates, LLC, acting as the Agent for Blue California, is submitting for FDA review Form 3667 and the enclosed CD, free of viruses, containing a GRAS Notification for Rebaudioside I. Along with Blue California's detennination of safety, an Expert Panel of qualified persons was assembled to assess the composite safety information of the subject substance with the intended use as a table top sweetener and as a general purpose non-nutritive sweetener forincorporation into food in general, other than infant fonnulas and meat and poultry products. The attached documentation containsthe specific information that addresses the safe human food uses for the subject notified substance as discussed in the GRAS guidance document. If additional infonnation or clarification is needed as you and your colleagues proceed with the review, please feel free to contact me via telephone or email. We look forward to your feedback. Sincerely, William J. Rowe, President Agent for Blue California GRAS Associates, LLC 11810 Grand Park Ave FEB O 6 2020 Suite 500 North Bethesda, MD 20852 OftlLtuf [email protected] fOOO ADDITIVE SAFETY Enclosure: GRAS Notification for Blue California- Rebaudioside I LLC GRAS Notification of Rebaudioside I Food Usage Conditions for General Recognition of Safety on behalf of Blue California 30111 Tomas Rancho Santa Margarita, CA 92688 1/30/20 GRAS Notice – BESTEVIA® Rebaudioside I Blue California 1/30/20 TABLE OF CONTENTS FOREWORD ........................................................................................................................................................................................ 3 PART 1. SIGNED STATEMENTS AND CERTIFICATION ................................................................................................................. 4 A. Claim of Exclusion from the Requirement for Premarket Approval Pursuant to 21 CFR 170 Subpart E........................ 4 B. Name and Address of Responsible Parties ................................................................................................................... 5 C. Common Name and Identity of Notified Substance ....................................................................................................... 5 D. Conditions of Intended Use in Food ............................................................................................................................... 5 E. Basis for GRAS Conclusion ........................................................................................................................................... 5 F. Availability of Information ............................................................................................................................................... 6 PART 2. IDENTITY, METHOD OF MANUFACTURE, SPECIFICATIONS, AND PHYSICAL OR TECHNICAL EFFECT ................. 6 A. Chemical Identity of Ingredient ...................................................................................................................................... 6 1. Chemistry of Rebaudioside I .................................................................................................................................... 6 2. Chemistry of the Yeast Vector ................................................................................................................................. 8 B. Manufacturing Processes .............................................................................................................................................. 9 1. Catalytic Bioconversion Process .............................................................................................................................. 9 2. Extraction & Purification ......................................................................................................................................... 10 C. Product Specifications ................................................................................................................................................. 13 1. JECFA Specifications for Steviol Glycosides ......................................................................................................... 13 2. Specifications for Blue California’s Rebaudioside I Preparation and Supporting Methods .................................... 13 D. Physical or Technical Effect ......................................................................................................................................... 17 E. Stability ........................................................................................................................................................................ 17 1. Stability Data on Steviol Glycosides ....................................................................................................................... 17 2. Stability Data for Blue California’s BESTEVIA® Rebaudioside I ............................................................................. 18 PART 3. DIETARY EXPOSURE ...................................................................................................................................................... 19 A. Estimate of Dietary Exposure to the Substance .......................................................................................................... 20 B. Estimated Dietary Exposure to Any Other Substance That is Expected to be Formed In or On Food ........................ 21 C. Dietary Exposure to Contaminants or Byproducts ....................................................................................................... 21 PART 4. SELF-LIMITING LEVELS OF USE ................................................................................................................................... 21 PART 5. EXPERIENCE BASED ON COMMON USE IN FOOD BEFORE 1958 ............................................................................. 22 A. Other Information on Dietary Exposure ....................................................................................................................... 22 1. History of Traditional Medicinal and Human Food Use .......................................................................................... 22 B. Summary of Regulatory History of Enzyme Modified Steviol Glycosides .................................................................... 22 1. U.S. Regulatory History .......................................................................................................................................... 22 2. Canadian Regulatory History ................................................................................................................................. 23 3. European Regulatory History ................................................................................................................................. 23 4. Asian Regulatory History ........................................................................................................................................ 24 5. Other Regulatory History ........................................................................................................................................ 24 PART 6. NARRATIVE ...................................................................................................................................................................... 24 A. GRAS Criteria .............................................................................................................................................................. 31 B. Expert Panel Findings on Safety of Blue California’s BESTEVIA® Rebaudioside I ...................................................... 32 C. Common Knowledge Elements for GRAS Conclusions ............................................................................................... 33 1. Public Availability of Scientific Information ............................................................................................................. 33 2. Scientific Consensus .............................................................................................................................................. 34 D. Conclusion ................................................................................................................................................................... 34 PART 7. LIST OF SUPPORTING DATA AND INFORMATION IN THE GRAS NOTICE................................................................. 35 A. References .................................................................................................................................................................. 35 B. Appendices .................................................................................................................................................................. 47 GRAS ASSOCIATES, LLC Page 2 of 110 GRAS Notice – BESTEVIA® Rebaudioside I Blue California 1/30/20 APPENDIX 1 LIST OF SCIENTIFIC PUBLICATIONS REGARDING THE SYNTHESIS OF REBAUDIOSIDE
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