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High Purity Steviol Glycosides with Rebaudioside a and Stevioside As the Principal Components; Also See Section MA

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High Purity Steviol Glycosides with Rebaudioside a and Stevioside As the Principal Components; Also See Section MA ,- l11111ll111111 II 1111 GR 20482 Jacklight Lane Bend, OR 97702.3074 541-67895522 [email protected] December IO, 2010 Food and Drug Administration Center for Food Safety & Applied Nutrition Office of Food Additive Safety (HFS-200) 5100 Paint Branch Parkway College Park, MD 20740-3835 Attention: Dr. Robert L. Martin Re: GRAS Notification - High Purity Steviol Glycosides (295%) Dear Dr. Martin: On behalf of Sinochem Qingdao, Co. Ltd of Qingdao, China, we are submitting for FDA review a GRAS notification for High Purity Steviol Glycosides (295%). The attached documentation contains the specific information that addresses the safe human food uses for the subject notified substance as discussed in the GRAS guidance document. If additional information 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, (b) (6) Robert S. McQuate, Ph.D. CEO & Co-Founder GRAS Associates, LLC 20482 Jacklight Lane Bend, OR 97702-3074 54 1 -678-5522 [email protected] www.gras-associates.com Enclosure: GRAS Notification - High Purity Steviol Glycosides (295%)(in triplicate) 800002 GRAS ASSOCIATES, Page 1 of 1 LLC GRAS ASSESSMENT Of HIGH PURITY STEVIOL GLYCOSIDES (1 95%) Food Usage Conditions for General Recognition of Safety For SINOCHEM QINGDAO, Co., Ltd. Qingdao, China Evaluation by GRAS Expert Panel Richard C. Kraska, Ph.D., DABT Robert S. McQuate, Ph.D. Madhusudan G. Soni, Ph.D., FACN December IO, 2010 000003 GRAS Assessment Sinochem .High Purity Steviol Glycosides Paae 2 of 96 TABLE OF CONTENTS I . GRAS EXEMPTION CLAIM ................................................................................................................... 5 A . Claim of Exemption from the Requirement for Premarket Approval Pursuant to Proposed 21 CFR 170.36(~)(1)........................................................................................................ 5 B . Name & Address of Notifier ............................................................................................................ 5 C . Common Name & Identity of the Notified Substance............................................................................ 6 D. Conditions of Intended Use in Food.................................................................................................... 6 E. Basis for the GRAS Determination..................................................................................................... 6 F . Availability of Information.,................................................................................................................ 6 II . INTRODUCTION................................................................................................................................. 7 A . Objective ............................................................................................................................................................... 7 B . Foreword............................................................................................................................................................... 7 C . Summary of Regulatory History of Stevia& Stevia-Derived Sweeteners ................................................... -7 Ill . FDA Regulatory Framework ................................................................................................................ 10 IV . CHEMISTRY & MANUFACTURE OF HIGH PURITY STEVIOL GLYCOSIDES & RELATED SINOCHEM PRODUCT............................................................................................................................................ 11 A . Common or Usual Name .................................................................................................................................... 11 B . Chemistry of Steviol Glycosides ......................................................................................................................... 11 C . Accepted Identity Specifications for Food Grade Steviol Glycosides................................................................ -12 D. Manufacturing Processes................................................................................................................................... 13 1. Scientific & Patent Literature........................................................................................................................ 14 2. Processing to Produce Sinochem's SG 95 High Purity Steviol Glycosides (2 95%)................................... 14 E . Specifications for Sinochem's lceViaTM& Supporting Methods ........................................................................ 15 F . Stability Data for Stevioside & Rebaudioside A ................................................................................................. 15 IV. INTENDED FOOD USES & ESTIMATED DIETARY INTAKE ................................................................................ 18 A . Intended Uses.................................................................................................................................................... 18 B . Food Uses as Addressed by JECFA. Merisant & Cargill................................................................................... 18 C . Estimated Daily Intake ........................................................................................................................................ 20 D. Other Information on Human Exposure to Stevia............................................................................................... 22 V . SAFETY DATA FOR STEVIOL GLYCOSIDES......................................................................................................... 23 A . Safety Data on Steviol Glycosides: Reviews by Expert Bodies &Other Scientists ............................................ 23 1 . Summary of Interim & Final JECFA Reviews............................................................................................... 23 2. Summary of FSANZ Review of Steviol Glycosides ...................................................................................... 25 3. Summary of EFSA Review of Steviol Glycosides .......................................................................... 26 B . Safety Data on Stevioside & Stevia Extracts that are Predominantly Stevioside............................................... 26 1. Absorption, Distribution, Metabolism & Excretion (ADME)Studies ............................................................. 26 2. Acute Toxicity Studies.................................................................................................................................. 27 3. Subchronic Toxicity Studies ......................................................................................................................... 27 4 . Chronic Toxicity Studies............................................................................................................................... 29 GRAS ASSOCIATES. LLC 000004 GRAS Assessment Sinochem .High Purity Steviol Glycosides Page 3 of 96 5. Reproductive & Developmental Toxicity Studies ......................................................................................... 29 6 . Mutagenicity & Genotoxicity Studies........................................................................................................... 29 7. Clinical Studies & Other Reports in Humans............................................................................................... 30 C . Safety Data on Rebaudioside A ......................................................................................................................... 35 1. Absorption, Distribution, Metabolism & Excretion (ADME) Studies ............................................................. 36 2 . Subchronic Toxicity Studies......................................................................................................................... 37 3. Reproductive & Developmental Toxicity Studies ......................................................................................... 38 4 . Mutagenicity & Genotoxicity Studies .......................................................................................................... 39 5. Clinical Studies ........................................................................................................................................... 39 D. Studies on the Principal Metabolite: Steviol...................................................................................................... 40 1 . Acute Toxicity Studies......................................................................................................................... 40 2 . Developmental Toxicity Studies ................................................................................................................... -40 3. Mutagenicity & Genotoxicity Studies ............................................................................................................. 40 VI . DISCUSSION OF GRAS CRITERIA & PANEL SAFETY FINDINGS...................................................................... 44 A . GRAS Criteria...................................................................................................................................................... 44 B . Panel Findings on Safety Studies of Steviol Glycosides ...................................................................................... 45 1 . Safety Data on Stevioside
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