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O-Fucosyllactose GRAS Notice (GRN) No. 749 https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/default.htm y • LSRO OLUTIONS LLC COMPREHENSIVE GRAS ASSESSMENT Of the Proposed Uses of 2'-0-FUCOSYLLACTOSE In Term Infant Formulas, Toddler Formulas, and Foods Targeted to Toddlers 11/17/2017 LSRO Solutions, LLC 2286 Dunster Lane Rockville, MD 20854-6112 240-292-9445 I. Table of Contents II. FOREWORD ....................................................... .......... ................ ........................................................... 4 Ill. PART 1. SIGNED STATEMENTS AND CERTIFICATIONS .. .................. ................... .. .... .... ........ ...... .. .... .. ... 5 IV. PART 2. IDENTITY, MANUFACTURE, SPECIFICATIONS AND EFFECT .................... ...... .. .............. ......... 8 A. Chemical Identity.. ............. .... .............................. .. ..... .................................................. .... 8 1. Chemical Structure of 2FL ........ .......... .... ............................. ..................... .... ............ 8 2. Chemical and Physical Characteristics ........ ............................................................. 8 3. Manufacturing Process ........................................................................................ ... 9 4. Product Specifications for DuPont's 2FL.. .......... .. .................................................. 12 5. Batch Analysis ..................................... ....................... .... .................... .. ... ................ 13 6. Characterization of the Production Organism .... .. .... .. ...................................... ..... 15 7. Stability Data ...................................................................................... ......... ... ..... ... 17 8. Biogenic Amines .. ....... ................................... ......................................................... 21 9. GMO Status .. ... ........................... ....... ............................ ..... ............... ....... ..... .. ....... 21 10. Allergens ............. ...... ........ ..... ... .............. ............ .. ......... ... ....................... ....... .... .... 21 V. PART 3. DIETARY EXPOSURE ......................................................... ... ...................... .. ....... ..... ... .... .. ..... 22 A. Curre nt Dietary Exposure .. ..... ... ..... ... .. .. ... .... ... ............... ...... ... ....... .... ... ....... .. .......... ...... 22 B. Intended Human Food Uses (Estimated Daily lntake) ........................ .... ....................... 22 C. Estimate of Dietary Exposure of Other Substances ............................................. .. .... .. .. 24 VI. PART4. SELF-LIMITING LEVELS OF USE .. .................... ...................... ...... .................... .... ................ 26 A. Self-limiting ..... ....... .. ..... .. ... ................................. ..................... ...... ....... ... ....... ...... .......... 26 VII. PART 5. EXPERIENCE BASED ON COMMON USE IN FOODS ............ ........................ .... .. .......... .......... 27 A. Other Information on Dietary Exposure and History of Consumption ......................... 27 B. Summary of Regulatory History ....................................................... ..... .. ...... ................. 27 1. Regulatory Reviews of the Safety of 2FL....... .... .. .................................... .. ............. .. .27 VIII. PART 6. NARRATIVE ..... .... .. .. .. .............. ... .. ... .... ............ .... ..................... .............. .......... .... ................ ... ... 30 A. Biodisposition of 2FL ..... .......................... ...... ....... ... .... ..................... .............. ........ ... ... 30 B. Toxicity Studies on 2FL ................... ........................ ................. .... ...... ......... .................. 31 C. Summary of Safety lnformation ............................. ..... ................. .. ...... ... ....................... 39 1. Summary of Safety Information on 2FL............. .. .. .. ......................................... ....... 39 2. Acceptable Daily lntake .................. .. ........ ... .. .................... ... .. .. ............ .. ..... ... ........... 40 D. GRAS Criteria .. ... ..... ................. .. ............ ....... .. ........................... ... ................. ... ... .. .... .. .. .40 E. Common Knowledge Elements for GRAS Conclusions .. .. .. ...................................... ..... .41 1. Public Availability of Scientific Information ............ .................... .. ... .. .... ...... .... ........ .41 F. Expert Panel Conclusions ......................................................................................... .... .. 41 G. Conclusion of GRAS Status ......................... ...................................................... .. .. .......... 41 IX. PART 7. LIST OF SUPPORTING DATA AND INFORMATION ............ ............................... ...... .. .. .... ........... 43 A. List of Abbreviations ... ................... ... ..... ................ .. .. ... ..................... ... ... .... ....... ..... ...... 43 B. References ..... .. ........... ................. .................. ..... ... ...... ... ................... .. ............... .. .. .... .... 45 C. Appendices ....... ..... .. ... ............. ................... .. ... ....... ......... ........ ... ... ... ... ........ .. .. ....... ... .... 49 DuPont 2'-Fucosyl lactose in Infant Formula Page 2 November 2017 Figures Figure 1: Chemical Structure of 2FL. .............. ........................... ...... ............................ ... ......................... ..........8 Figure 2: Post fermentation process flow diagram... ................ ............................. .. ... .. ........... .. .......... .. ....... 11 Tables Table 1: Proposed Uses for DuPont's 2FL. ....................... .. ....... ... .. .......................... .......................... ........ ... ... 6 Table 2: Product Specifications for DuPont's 2FL.................. .............. .... ........................ ............................ 12 Table 3: Analysis of Production Batches of 2FL.. ..... ..... ........... ... ... .......... ... ............. .............. .. ... ......... .. .. .... 13 Table 4: Coding DNA Fragment lnserts ...................... .. ......... .. ........ .. ....................... .. .......................... ......... 17 Table 5: Stability Testing .............................................. .. .. .. .. ................ ............ ....... ...................... ... ............ .. 18 Table 6: Microbiological Stability Testing ... ... ..... .. .. ...... .. ............ ... .............................................................. 19 Table 7: Substantial Chemical Equivalence of 2FL from Various Manufacturers .... ....... ...... .... ........... 20 Table 8: Intended Human Food Uses of DuPont's 2FL............. ........................ .. ....................................... .22 Table 9: Estimated Daily Intake of DuPont's 2FL .............. ....... .. ... ......... .... .. ....... .. ............................... ..... .. 23 Table 10: GRAS Notifications and Self Affirmed GRAS Determinations 2FL. .. .............................. ......... ... 29 Table 11: Preclinical Testing ....................................... ........................ .. ..................... .. .... .. ......... ..................... 33 Appendices Appendix A: Certificates of Analysis....... .. .. .. ................... ............. .. ... ................ ... ..... ... ................ .. .. .... .. A-1 Appendix B: Production Strain Modifications .. .. .... ........... ........ ................ ... ................................ .. ...... A-16 Appendix C: Stability Tests .. .... .. ... ..................... ....................................... ... ... ....... .. ........ ... ... ............... A-25 Appendix D: Chemical ldentification .................... ... ... ....... .. ........ .. ... .. ........ ...... ..... ................. .... .... .. ....A-57 Appendix E: Affirmations...... .............. .. ....... .. ..... .. ... .................................. .... .................... ........... ... .. .. A-91 Appendix F: Test for Residual Bacterial DNA ........ ... ..... .. ..... ...... .. .. .... ...... ... .. .. ..... .... .. ....... ............... .. .A-94 Appendix G: Summary of Animal Studie ........ ... ...... .. ........ .............. .. .. .. .. ..... .... .............. ............... .....A-105 Appendix H: Expert Panel Consensus Statement... ..................... ..... ....... .... ................ ..... .... .............. A-114 ) DuPont 2' -Fucosyllactose in Infant Formula Page 3 November 2017 II. FOREWORD Ingredients for use in foods must undergo premarket approval by the U.S. Food and Drug Administration (FDA) as food additives or, alternatively, the ingredients to be incorporated into foods must be determined to be Generally Recognized as Safe (GRAS} . In 1997, the FDA altered the GRAS determination process by eliminating the formal GRAS petitioning process and replacing the petitioning process with a notification procedure. While outlining the necessary content to be considered in making a GRAS determination, FDA encouraged that such determinations be provided to FDA in the form of a notification. However, notifying FDA of such determinations is strictly voluntary. At the request of Danisco USA Inc. (dba DuPont Nutrition and Health),
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