GRAS Notice (GRN) No. 747 https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/default.htm Exponent 11 50 Connecticut Ave., NW EXponenr Suite 11 00 Washington, DC 20036 telephone 202-772-4900 facsim ile 202-772-4979 www.exponent.com November 14, 2017 Office ofFood Additive Safety (HFS-200) Center for Food Safety and Applied Nutrition Food and Drug Administration 500 l Campus Drive College Park, MD 20740 Subject: GRAS Notification for the Use of Calcium Lactate in Potato and Vegetable Snacks and Sweetened Crackers Project No. 1607280.000 Dear Sir/Madam: In accordance with 2 1 CFR part 170, subpart E, PepsiCo, hereby provides a notice of a claim that the food ingredient described in the enclosed notification document is excluded from the premarket approval requirement ofthe Federal Food, Drug, and Cosmetic Act because the notifier has concluded such use to be generally recognized as safe (GRAS), based on scientific procedures. One paper copy of the notification is provided as required; we also have provided a copy ofthe notification on the enclosed CD-ROM. Ifyou have any questions or require additional information, please do not hesitate to contact me at 202-772-4915, or [email protected]. Sincerely, (b) (6) Nga Tran, DrPH, MPH Principal Scientist ~~©~U~~~ 1607280.000- 04 16 NOV 16 20'7 000001 OFFICE OF FOOD A001TlVE SAFEi'Y ( GRAS Conclusion for the Use of Calcium Lactate in Potato and Vegetable Snacks and Sweetened Crackers SUBMITTED BY: PepsiCo, Inc 700 Anderson Hill Road Purchase, NY 10577 SUBMITTED TO: U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Food Additive Safety HFS-200 5100 Paint Branch Parkway College Park, MD 20740-3835 CONTACT FOR TECHNICAL OR OTHER INFORMATION: Nga Tran Principal Scientist Exponent, Inc. 1150 Connecticut Avenue, NW, Suite 1100 Washington, DC 20036 November 14, 2017 ~~~~~~~lQ) NOV 1 6 20i7 OFFICE OF FOOD ADDITIVE SAFETY ­ 1607280.000 - 6921 Page 1of104 000002 Table of Contents Page TABLE OF CONTENTS ........................................................................................................................... 2 LIST OF TABLES ...................................................................................................................................... 5 LIST OF FIGURES .................................................................................................................................... 6 LIST OF ACRONYMS .............................................................................................................................. 7 PART 1: SIGNED STATEMENTS AND CERTIFICATION ............................................................... 9 Name and Address of Notifier ............................................................................................................................ 9 Name of GRAS Substance ................................................................................................................................ 9 Intended Use and Consumer Exposure ............................................................................................................. 9 Basis for Conclusion of GRAS Status ............................................................................................................... 9 Pre-Market Approval Exclusion Claim ............................................................................................................ 9 Availability of Information .............................................................................................................................. 10 Exemptions from Disclosure ............................................................................................................................ 10 Certification Statement .................................................................................................................................... 10 PART 2. IDENTITY, METHOD OF MANUFACTURE, SPECIFICATIONS, AND PHYSICAL OR TECHNICAL EFFECT ............................................................................................................................ 11 Identity ............................................................................................................................................................. 11 Manufacturing Information ............................................................................................................................... 11 Specifications .................................................................................................................................................... 12 Technical Effect ................................................................................................................................................. 14 PART 3. DIETARY EXPOSURE .......................................................................................................... 15 Proposed Use and Levels ................................................................................................................................... 15 Estimated Daily Intakes (EDI)............................................................................................................................. 15 1607280.000 - 6921 Page 2 of 104000003 Food and Nutrient Database for Dietary Studies (FNDDS) .................................................................................... 15 24-hour Dietary Supplement Use ............................................................................................................................ 16 Analysis ........................................................................................................................................................... 16 Background Sources of Calcium ............................................................................................................................ 16 Proposed Use .......................................................................................................................................................... 17 Cumulative EDI – Calcium ..................................................................................................................................... 17 Results ............................................................................................................................................................. 18 EDI from Proposed Uses ........................................................................................................................................ 18 Cumulative Estimated Daily Intake (CEDI) for Calcium ....................................................................................... 19 Summary ......................................................................................................................................................... 23 PART 4. SELF‐LIMITING LEVELS OF USE ..................................................................................... 24 PART 5. EXPERIENCE BASED ON COMMON USE IN FOOD BEFORE 1958......................... 25 PART 6. NARRATIVE ........................................................................................................................... 26 Regulated Uses ................................................................................................................................................. 26 Safety Data ....................................................................................................................................................... 27 A. Calcium Lactate and Lactic Acid .................................................................................................................... 27 Biological Occurrence and Metabolism ............................................................................................................. 28 Acute Toxicity..................................................................................................................................................... 28 Subchronic Toxicity ............................................................................................................................................ 28 Chronic Toxicity.................................................................................................................................................. 29 Genotoxicity ....................................................................................................................................................... 30 Reproductive and Developmental Toxicity ........................................................................................................ 30 Established Oral Exposure Limits ....................................................................................................................... 30 Safety Data Summary......................................................................................................................................... 31 B. Calcium .......................................................................................................................................................... 31 Absorption, Distribution, Metabolism, and Excretion ....................................................................................... 32 Absorption ..................................................................................................................................................... 32 Distribution...................................................................................................................................................