GRAS Notice (GRN) No. 793 https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory FEB 1 5 2018 OFFICE OF February 14, 2018 FOOD ADDTI1VE SAFETY Dr. Paulette Gaynor Office of Food Additive Safety (HFS-200) Center for Food Safety and Applied Nutrition Food and Drug Administration 5001 Campus Drive College Park, MD 20740-3835 Dear Dr. Gaynor: Re: GRAS Notices for the Use of Savory Base 100 "Corn Sauce" and Savory Base 200 "Corn Sauce" in Food Products In accordance with 21 CFR §170 Subpart E consisting of §170.203 through 170.285, I am submitting as the notifier [NestecS.A., Avenue Nestle 55, CH-1800, Vevey, Switzerland], one hard copy and one electronic copy (on CD) of each Notice that Savory Base 100 "Corn Sauce" and Savory Base 200 "Corn Sauce", as defined in the enclosed documents, are GRAS, on the basis of scientific procedures, under specific conditions of use as flavoring ingredients, and therefore, are not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act. Information setting forth the basis for the GRAS status, which includes detailed information on the notified substances and a summary of the basis for the GRAS status, as well as a consensus opinion of an independent panel of experts in support of the safety of Savory Base 100 "Corn Sauce" and Savory Base 200 "Corn Sauce", under the intended conditions of use, also are enclosed for review by the Agency. In a meeting between the FDA's Food Labeling and Standards Staff and the notifier, which was held on February 7, 2018, a consensus was reached supporting the use of 'corn sauce' as the common or usual name for both ingredients. When the corn sauce is used as an ingredient in food, the raw materials used to create the corn sauce would be disclosed such as "corn sauce (cultured corn starch, water, salt)". The enclosed electronic files for the Notices entitled, GRAS Notice for the Use of Savory Base 100 "Corn Sauce" in Food Products and GRAS Notice for the Use of Savory Base 200 "Corn Sauce" in Food Products were scanned for viruses prior to submission and is thus certified as being virus-free using McAfee VirusScan 8.8. Should you have any questions or concerns regarding these GRAS Notices, please do not hesitate to contact me at any point during the review process so that we may provide a response in a timely manner. Yours sincerely Anne Petersen Regulatory and Scientific Affairs Manager Nestle PTC Singen Lebensmittelforschung GmbH GRAS NOTICE FOR THE USE OF SAVORY BASE 200 “CORN SAUCE” IN FOOD PRODUCTS PREPARED FOR: Office of Food Additive Safety (FHS-200) Center for Food Safety and Applied Nutrition Food and Drug Administration 5100 Campus Drive College Park, MD 20740 PREPARED BY: Nestec S.A. Avenue Nestlé 55 CH-1800 Vevey Switzerland DATE: 8 February 2017 GRAS Notice for the Use of Savory Base 200 “Corn Sauce” in Food Products TABLE OF CONTENTS PART 1. §170.225 SIGNED STATEMENTS AND CERTIFICATION ........................................................................... 4 1.1 Name and Address of Notifier .................................................................................................. 4 1.2 Common Name of Notified Substance ..................................................................................... 4 1.3 Conditions of Use ...................................................................................................................... 4 1.4 Basis for GRAS ........................................................................................................................... 5 1.5 Availability of information ........................................................................................................ 5 1.6 Freedom of Information Act, 5 U.S.C. 552 ................................................................................ 6 PART 2. §170.230 IDENTITY, METHOD OF MANUFACTURE, SPECIFICATIONS, AND PHYSICAL OR TECHNICAL EFFECT ................................................................................................................................. 6 2.1 Identity ...................................................................................................................................... 6 2.1.1 Common or Usual Name .............................................................................................. 6 2.1.2 Chemical Name ............................................................................................................ 6 2.1.3 Chemical Abstract Service (CAS) Number .................................................................... 6 2.1.4 Chemical and Physical Characteristics ......................................................................... 6 2.2 Method of Manufacturing ........................................................................................................ 7 2.2.1 Raw Materials and Processing Aids ............................................................................. 7 2.2.2 Manufacturing Process ................................................................................................ 7 2.3 Product Specifications and Batch Analysis ............................................................................... 9 2.3.1 Product Specifications ................................................................................................. 9 2.3.2 Batch Analyses ........................................................................................................... 10 2.3.3 Additional Chemical Characterization ....................................................................... 11 2.3.4 Other Impurities from Fermentation Media ............................................................. 11 2.3.5 Other Internal Quality Control Analyses .................................................................... 13 2.4 Stability Data ........................................................................................................................... 14 2.4.1 Sensory Stability......................................................................................................... 14 2.4.2 Chemical Stability ...................................................................................................... 17 2.4.3 Microbiological Stability ............................................................................................ 18 PART 3. §170.235 DIETARY EXPOSURE ............................................................................................................. 18 3.1 Current Regulatory Status in the United States...................................................................... 18 3.2 Estimated Dietary Consumption of Savory Base 200 from Intended Food Uses ................... 19 3.2.1 Methodology ............................................................................................................. 19 3.3.2 Estimated Intake of Savory Base 200 from Proposed Food-Uses.............................. 20 3.2 Summary and Conclusions ...................................................................................................... 21 PART 4. §170.240 SELF-LIMITING LEVELS OF USE ............................................................................................. 21 PART 5. §170.245 EXPERIENCE BASED ON COMMON USE IN FOOD BEFORE 1958 ......................................... 21 Nestec S.A. 8 February 2017 1 PART 6. §170.250 NARRATIVE AND SAFETY INFORMATION ............................................................................. 22 6.1 Metabolic Fate ........................................................................................................................ 22 6.2 Toxicological Studies ............................................................................................................... 22 6.2.1 Acute Toxicity............................................................................................................. 22 6.2.2 Repeated-Dose Toxicity ............................................................................................. 22 6.2.3 Mutagenicity and Genotoxicity ................................................................................. 25 6.3 Additional Safety Information on Major Constituents of Savory Base 200 ............................ 28 6.3.1 IMP ............................................................................................................................. 28 6.3.2 Glycine ....................................................................................................................... 29 6.3.3 Formic Acid ................................................................................................................ 30 6.4 Safety of the Source Organism ............................................................................................... 30 6.4.1 Identity ....................................................................................................................... 30 6.4.2 Pathogenicity and Toxicogenicity .............................................................................. 30 6.6 Conclusions ............................................................................................................................. 31 PART 7. §170.255 LIST OF SUPPORTING DATA AND INFORMATION ................................................................ 32 List of Appendices Appendix A Full Study Report for In Vitro Mammalian Cell Micronucleus Test (Chevallier, 2017) Appendix B Expert Panel Consensus Statement List of Figures and Tables Figure 2.2.2-1 Schematic Overview