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GRAS Notice 684, Mung Bean Protein Isolate

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GRAS Notice 684, Mung Bean Protein Isolate GRAS Notice (GRN) No. 684 http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/default.htm ORIGINAL SUBMISSION ~OLSINELLI 1401 Eye Street NW, Suite 800, Washington, DC 20005 • (202) 783-3300 Stuart M . Pape December 15, 2016 (202) 626-8392 lPJ~CG~DW~[Q)' [email protected] DEC 1 9 2016 VIA FEDERAL EXPRESS ~ OFFICE OF L OOD ADDITIVE SAFETY _j Office of Food Additive Safety Center for Food Safety and Applied Nutrition Food and Drug Administration 5001 Campus Drive College Park, MD 20740 Re: GRAS Notice for Mung Bean Protein Isolate To Whom It May Concern: Accompanying this letter is a notice pursuant to regulations of the Food and Drug Administration found at 21 CFR Part 170 setting forth the basis for the conclusion reached by the submitter, Hampton Creek, Inc., that mung bean protein isolate is generally recognized as safe under the intended conditions of use described in the notice. The notice is contained in a binder. In addition, we include a USB flash drive that contains a complete copy of the notice. I hereby certify that the electronic files contained on the flash drive were scanned for viruses prior to submission, and thus certified as be·ng virus-free using McAfee VirusScan 8.8. (b) (6) ;/ ( M. \_ Counsel to Hampton Meek, Inc. SMP:vp Enclosures polsinelli.com Atlanta Boston Chicago Dallas Denver Houston Kansas City Los Angeles Nashville New York Phoenix St. Louis San Francisco Washington, D.C. Wilmington Polsinelli PC, Pol si nelli LLP in Cal~orn ia [PJ~~~~%7~[)) DEC 1 9 2016 OFFICE OF FOOD ADDITIVE SAFETY GRAS Notice for a Mung Bean Protein Isolate 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 Submitted by: Hampton Creek, Inc. 2000 Folsom Street San Francisco, CA 94110 December 13, 2016 GRAS Notice for a Mung Bean Protein Isolate Table of Contents Page Part 1. § 170.225 Signed Statements and Certification ...... .. .. ...... .......... .... .. .......... .. ................ .. .4 1.1 Name and Address of Notifier .. ... .............................. .............. .. ........................... 4 1.2 Common Name of Notified Substance .. .. .................. .... ................ .... ............ ...... 5 1.3 Conditions of Use .... .... ....... ......................... ....... .. .... ........................... ................ 5 1.4 Basis for GRAS .................................... ... .................... .. ....... .. ............................. 7 1.5 Availability of Information ..... ....................................... .. .................. .. ..... ...... ........ 7 1.6 Freedom of Information Act, 5 U.S.C. Section 552 ...... .... .................. ................... 7 Part 2. §170.230 Identity, Method of Manufacture, Specifications, and Physical or Technical Effect. .... ...... ....... .... ..................................... ......................... .. .. ....... ............. .. .7 2.1 Identity........................................................................ .. ...... .. ......................... ...... 7 2.2 Method of Manufacturing ................................ ... ........... .. .................................... .8 2.2.1 Raw Materials and Processing Aids ................ .. .. .............. .......... ............. 8 2.2.2 Manufacturing Process ... ....................... ........ ... ...... .. ... .. .. ...................... ... 8 2.2.3 Quality Control ...... .. ................................... ...... ..... ... ... .... ....... .. .. ............ 11 2.3 Product Specifications and Batch Analyses ........................ ...... .. .. ..................... 11 2.3.1 Proposed Product Specifications .... .. .. .. .................... ........ ...... ................ 11 2.3.2 Batch Analyses .. ............... .... .. .......... .. .................................... .. ... ... ....... 12 2.3.3 Additional Analytical Information ............... ...... .. ..... .. .................. ............ 12 2.4 Analysis for Presence of Allergens .... .. .. ........................................ .. .. .... .. ........ .. 19 2.5 Stability... .... .. .... ....... .................... ............ .. .. ................ ... .... .... .. ..... ........ .. .......... 21 2.5.1 Mung Bean Protein Isolate Stability ................ .......... .... .. .... ................ .. .. 21 2.5.2 Mung Bean Patty Stability .. .. .... .. .. .................. .................................... .. .. 22 Part 3. § 170.235 Dietary Exposure ................................... ..... ..... ........ .. .... ....... ... ...... ... .. ........... 24 3.1 Probable Consumption .................................................. .......................... .......... 24 Part 4. § 170.240 Self-Limiting Levels of Use .. ............................ .......... .. ...... .... ...... .................. 27 Part 5. § 170.245 Experience Based on Common Use in Food Before 1958 .. ........................... 27 Part 6. §170.250 Narrative ............ ... ................................... .. ..... ............... .... ....................... .. ... 27 6.1 Compositional Analysis ................................... ....... ..... ................................. ..... 28 6.2 History of Safe Use ..................................... ... .... .. ............ .. .. ........... ......... .. ........ 28 6.3 Nutritionallnformation................................ ........... .... ........................... .. .. .. ..... ... 29 6.3.1 In Vitro Protein Digestibility .. .. .................... .. ...................... ...... .... .. .... .. .. 29 6.3.2 Protein Quality Evaluation ...................................................... .. .............. 30 6.4 Allergenicity Potential ..... ... ................................................ ... .. .. .................. .. .. ... 35 6.5 Expert Panel Evaluation ...... .. ...... .............................. .... .. ... ...... ... ... .. ..... ... .. ... ..... 37 6.6 Conclusion ................... ... .... .. .. ... ............................. ...... .................... .. ..... .......... 38 Part 7. §170.255 List of Supporting Data and lnformation ...................... ........ .. ......................... 39 Hampton Creek, Inc. December 13, 2016 List of Figures and Tables Figure 2.2.2-1 Schematic Overview of the Manufacturing Process for the Mung Bean Protein Isolate ..................................................... .... ... .................................. 10 Figure 2.5.2.2-1 Texture Profile Analysis of Mung Bean Patties Stored at -20 and -80°C Over 12 Weeks ............................................... ................................... 23 Table 1.3-1 Summary of the Individual Proposed Food-Uses and Use Levels for Mung Bean Protein Isolate in Conventional Food and Beverage Products ........... .. .................................................... ............... .... ..... ............... 5 Table 2.1-1 Taxonomic Classification of Mung Bean ........ .. .. .. .... .. .... .... .... ........................ 8 Table 2.2.1-1 Processing Aids/Additives Used During Manufacturing ..................................8 Table 2.3.1-1 Proposed Product Specifications of Hampton Creek's Mung Bean Protein Isolate ..... .. .. .. .............. ... ...... .. ..... ............. .... .. .. ....... ......... .. ..... ... ... ... 11 Table 2.3.2-1 Results of Analyses of 4 Non-Consecutive Batches of Hampton Creek's Mung Bean Protein Isolate ... ........... ................... .. .. ..... .... ................ 12 Table 2.3.3.1-1 Amino Acid Composition of 4 Batches of the Mung Bean Protein lsolate .. .................................. ...................................................................... 13 Table 2.3.3.2-1 Analyses for Vitamin, Mineral, Carbohydrate and Lipid Content of the Mung Bean Protein Isolate .............................................................. ............. 14 Table 2.3.3.3.1-1 Analyses for Residual Chlorinated and Organophosphate Pesticides in Representative Batches of the Mung Bean Protein Isolate .... ........ .... .. ..... 15 Table 2.3.3.3.2-1 Analyses for Residual Dioxin and Polychlorinated Biphenyls in Representative Batches of the Mung Bean Protein Isolate .. .. ....................... 16 Table 2.3.3.3.3-1 Analyses for Residual Mycotoxins in Representative Batches of the Mung Bean Protein Isolate ....... ............................... .. ... ... .. ... ........................ 17 Table 2.3.3.4-1 Relative Abundance of Protein-Based Anti-Nutritional Factors in Representative Batches of the Mung Bean Protein Isolate and the Mung Bean Flour .......................... .... ...... .. .................. ... .............................. 18 Table 2.4-1 Relative Abundance of Putative Allergen Matches in Representative Batches of the Mung Bean Protein Isolate and Mung Bean Flour .......... .. .... 20 Table 2.4-2 Relative Abundance of Putative Allergen Matches in Spray-Dried, Uncooked, and Cooked Mung Bean Protein Isolate Samples ...................... 21 Table 2.5.1-1 Interim Results of Stability Testing of Mung Bean Protein Isolate when Stored at Room Temperature ..... .. .. .. .. .......................................................... 22 Table 2.5.2.1-1 Results of Stability Testing of Mung Bean Patties when Stored for 12 Weeks under Frozen Conditions (-20 and -80°C) .. .. ........ .. .................... .. 22 Table 3.1-1 Global Consumption of Mung Bean Protein .......... ........ ........................ ......
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