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GRAS Notice (GRN) No GRAS Notice (GRN) No. 715 https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/default.htm GRAS Notice - Rebaudioside D Blue California 6/26/17 TABLE OF CONTENTS FOREWORD ......................................................................................................................................................................................... 4 PART 1. SIGNED STATEMENTS AND CERTIFICATION ................................................................................................................. 4 A. Basis of Exclusion from the Requirement for Premarket Approval Pursuant to Proposed 21 CFR 170.36(c)(1) ... ........ 4 B. Name and Address of Responsible Party ....................................................................... ................... ............ ................. 5 C. Common Name and Identity of Notified Substance........................................................ .............................................. .. 5 D. Conditions of Intended Use in Food ............................................................................................................................... 5 E. Basis for GRAS Conclusion........................................................................... ................................................................. 6 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 Steviol Glycosides ... ............ ........................... ... .................... ... ....................................... ... ...... ........... 7 2. Chemistry of Rebaudioside D................................................................................................................................... 9 3. Chemistry of the Yeast Vector ...... ...... ... .............................. ......... ............... ........... ... ...... ... ... ...... ... ......... ...... ......... 10 B. Manufacturing Process ... ... .. ... ... ... ............................................................... ............................................... .................. 11 1. Scientific & Patent Literature ............................................................................................................................ ...... 12 2. Manufacturing Process for Rebaudioside D ........................................................................................................... 12 C. Product Specifications .................................................................. ................................... ............................................. 15 1. JECFA Specifications for Steviol Glycosides .................................... .. .................................................................... 15 2. Specifications for Blue California's Rebaudioside D Preparation and Supporting Methods ................................... 15 D. Physical or Technical Effect ..... .. ... ..................................... .................. .............................................. .................. ......... 17 PART 3. DIETARY EXPOSURE ....................................................................................................................................................... 20 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 ....... ...... ............ 22 C. Dietary Exposure to Contaminants or Byproducts...................... ....................... ........................................................... 22 PART 4. SELF-LIMITING LEVELS OF USE .................................................................................................................................... 22 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 Rebaudioside D........... ......... .................................. ............ ................................... 23 1. U.S. Regulatory History ...... ..... ....... .. ........... .. ... ...... ... ... .......................... ............... ... .. ....... ..................................... 23 2. Canadian Regulatory History .... .................. ......................................... ............ ... ..................... ............................... 27 3. European Regulatory History................ ............ ...... ........................... .. ................................................................... 28 4. Asian Regulatory History .......... ... ... ............ ...... ...... ............................................... ................................................. 29 5. Other Regulatory History ............. ... ... ... ... ...... ......... ........................................................... ...... ... ... ...... ... ... ... ... ... ....30 PART 6. NARRATIVE....................................................................................................................................................................... 31 A. GRAS Criteria ......................................................................................................................................... ... ... ... ......... .... 31 B. Blue California's Findings on the Safety of Rebaudioside D .. ............ ............................ ..............................................32 C. Expert Panel Findings on the Safety of Rebaudioside D..............................................................................................34 D. Common Knowledge Elements for GRAS Conclusions ...... ...... ................. ...... ...... ...... .......................... ............ .......... 38 1. Public Availability of Scientific Information .............................................................................................................. 38 2. Scientific Consensus ........ ... ... .......................................... ............................................................................. .........39 E. Conclusion ................................................................................................ ... ................................................................. 40 PART 7. LIST OF SUPPORTING DATA AND INFORMATION IN THE GRAS NOTICE................................................................. 41 A. List of Acronyms ................................................................... .................................................................................. ...... 41 B. References .... ................................................................. ... ... ... ...... ... ... ......................... ... ... ...... ... ... ......... ............ ......... 45 C. Appendices .... ........................................ ................ ... ................................................................ ....................................54 APPENDIX 1 LIST OF SCIENTIFIC PUBLICATIONS REGARDING THE SYNTHESIS OF REBAUDISIDE D..................... 55 APPENDIX 2 STEVIOL GLYCOSIDES RAW MATERIAL FLOW CHART AND SPECIFICATIONS ........................................... 56 GRAS ASSOCIATES, LLC Page 2of129 GRAS Notice - Rebaudioside D Blue California 6/26/17 APPENDIX 3 REGULATORY STATUS OF RAW MATERIALS AND PROCESSING AIDS USED IN THE MANUFACTURE OF BESTEVIATM REB D 95o/o ....................................................................................................................................................... 59 APPENDIX 4 METHOD OF ANALYSIS FOR BESTEVIATM REB D 95%.................................................................................... 60 APPENDIX 5 CERTIFICATES OF ANALYSIS FOR MULTIPLE BATCHES OF BESTEVIATM REB D 95%.............................. 67 APPENDIX 6 ANALYTICAL CHROMATOGRAMS FOR MULTIPLE PRODUCTION BATCHES OF REBAUDIOSIDE D......... 73 APPENDIX 7 PESTICIDE TESTING REPORT FOR REBAUDIOSIDE D ................................................................................... 84 APPENDIX 8 RELATIVE SWEETNESS INTENSITY STUDY...................................................................................................... 88 APPENDIX 9 ESTIMATED DAILY INTAKE LEVELS OF STEVIOL GLYCOSIDES .................................................................... 90 APPENDIX 10 SUMMARY OF PUBLISHED SAFETY REVIEWS ................................................................................................. 95 APPENDIX 11 STUDIES ON STEVIOL GLYCOSIDES PREPARATIONS THAT ARE PRIMARILY MIXTURES OF STEVIOSIDE & REBAUDIOSIDE A............................................................................................................................................................
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