GRAS Notice (GRN) No. 804 https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory Pea Protein GRAS Notice THE SAFETY AND THE GENERALLY RECOGNIZED AS SAFE (GRAS) STATUS OF THE PROPOSED USE OF PEA PROTEIN IN HUMAN FOOD Submitted By: Burcon NutraScience Corporation Prepared By: Marc C. Sanchez, Esq. (Contract In-House Counsel and Consultants, LLC d/b/a FDA Atty) , ~~~~~~~[Q) JUN 1 S 20,s OFFICE OF FOOD AODlTlVE SAFEiV ~ • 1 Burcon NutraScience Corporation Page 00 I of 270 Pea Protein GRAS Notice Table of Contents INTRODUCTION ............................................................................................................... 4 1. ADMINISTRATIVE INFORMATION ....................................................................... 4 A. CLAIM REGARDING GRAS STATUS............................................................................. 4 B. NAME AND ADDRESS ................................................................................................. 5 C. COMMON OR USUAL NAME OF GRAS SUBSTANCE ...................................................... 5 D. BASIS FOR GRAS DETERMINATION ............................................................................ 5 E. EXEMPTION FROM FOOD ADDITIVE PETITION .............................................................. 6 F. AVAILABILITY OF INFORMATION FOR FDA REVIEW ..................................................... 6 G. EXEMPTION FROM DISCLOSURE .................................................................................. 6 H. CERTIFICATION ......................................................................................................... 6 I. NAME AND POSITION OF SIGNATORY........................................................................... 6 2. PRODUCT IDENTITY AND SPECIFICATIONS ...................................................... 7 A. PEAZAZZ® & PEAZAC® GENERAL DESCRIPTION ........................................................... 7 B. INTENDED USE .......................................................................................................... 7 C. PRODUCT SPECIFICATIONS ......................................................................................... 7 i. Sensory Characteristics ......................................................................................... 7 ii. Physical Characteristics ........................................................................................ 7 iii. Specifications ........................................................................................................ 8 1. Proximates ............................................................................................................ 8 2. Microbiology......................................................................................................... 8 3. Heavy Metals ........................................................................................................ 8 iv. Analyses................................................................................................................ 9 v. Labeling and Storage Information ........................................................................ 18 vi. Allergens ............................................................................................................ 18 MANUFACTURING PROCESS ....................................................................................... 20 A. PROCESS FLOW CHART ............................................................................................ 20 B. SAFETY OF SUBSTANCES USED IN THE MANUFACTURE OF PEAZAZZ® & PEAZAC® ........ 21 C. MANUFACTURING PROCESS DETAILS ........................................................................ 21 D. DISCUSSION ON WHY NOTICE IS NOT DUPLICATIVE ................................................... 22 3. CONDITIONS OF INTENDED USE IN FOOD ........................................................ 24 A. OVERVIEW OF CONSUMPTION ................................................................................... 24 B. FUNCTIONAL BENEFIT IN FOOD ................................................................................ 24 C. APPLICATION OF USAGE ESTIMATES ......................................................................... 24 D. EXPOSURE ESTIMATES – INTERTEK REPORT .............................................................. 25 4. SELF-LIMITING LEVELS OF USE ............................................................................. 26 5. BASIS FOR CONCLUSION OF GRAS STATUS HISTORY OF USE .......................... 27 6. BASIS FOR CONCLUSION OF GRAS STATUS SCIENTIFIC PROCEDURES (NARRATIVE) .................................................................................................................. 27 A. INCORPORATION OF DATA UNDER 21 CFR 170.215 ................................................... 27 B. RELEVANCE OF DATA INCORPORATED UNDER 21 CFR 170.215 .................................. 27 C. HUMAN CONSUMPTION OF PEA PROTEINS ................................................................. 27 D. SAFETY DATA ......................................................................................................... 28 E. EXPERT PANEL ........................................................................................................ 31 7. REFERENCES AND LIST OF TABLES, FIGURES AND SUPPORTING DATA ....... 32 A. LIST OF REFERENCES ............................................................................................... 33 B. LIST OF TABLES AND FIGURES .................................................................................. 34 Burcon NutraScience Corporation Page 002 of 270 Pea Protein GRAS Notice 8. APPENDIX I INTERTEK EXPOSURE ESTIMATE .................................................... 36 9. APPENDIX II MERIEUX NUTRISCIENCE COA REVIEW ....................................... 174 Burcon NutraScience Corporation Page 003 of 270 Pea Protein GRAS Notice June 15, 2018 PEA PROTEIN GRAS NOTICE ® ® Peazazz / Peazac INTRODUCTION Burcon NutraScience Corporation has determined that the intended use of its pea protein products Peazazz® and Peazac® are Generally Recognized as Safe, based on section 201(s) of the Food Drug and Cosmetic Act and provisions of the related regulations (Subpart E of Part 170). The pea proteins are marketed and intended for use a source of protein in foods, such as baked goods and baking mixes, beverages and beverage bases, breakfast cereals, cheeses, coffee and tea, confections and frostings, dairy product analogs, egg products, fats and oils, fish products, frozen dairy desserts, fruit and water ices, gelatins, puddings, and fillings, grain products and pastas, gravies and sauces, meat products, milk products, nut and nut products, plant protein products, poultry products, processed fruits and fruit juices, processed vegetables and vegetable juices, snack foods, soft candy, and soups and soup mixes. The pea proteins may be incorporated into food products to provide nutritional value or functionality. The determination of GRAS status is based on scientific procedures, in accordance with 21 C.F.R. § 170.30(b) and conforms to the guidance issued in § 170.36. 1. ADMINISTRATIVE INFORMATION A. Claim Regarding GRAS Status Burcon NutraScience Corporation is hereby submitting a GRAS notice (the “Notice”) in accordance with 21 CFR 170.255 Part 1. This Notice based on scientific procedures, in accordance with 21 C.F.R. § 170.30(b) and conforms to the guidance issued in § 170.36. Burcon NutraScience Corporation Page 004 of 270 Pea Protein GRAS Notice B. Name and Address Notifier/Manufacturer Notifier’s Agent Burcon NutraScience Corporation Marc C. Sanchez, Esq. 1946 West Broadway Contract In-House Counsel and Vancouver, BC Consultants LLC (d/b/a FDA Atty) V6J 1Z2 1717 Pennsylvania Ave. #1025 Washington, D.C. 20006 Ph: 202.765.4491 E-mail: [email protected] C. Common or Usual Name of GRAS Substance The name of the notified substance is referred to as pea protein, pea protein product, pea protein concentrate or pea protein isolate. The trade names of the products are Peazazz® and Peazac®. Peazazz® and Peazac® are products formed by purifying protein from Pisum sativum L. Plant Symbol: PISA6 Common Alternate Names of Pisum sativum L.: garden pea, field pea, spring pea, English pea, common pea, green pea (Pisum sativum L. ssp. sativum); Austrian winter pea (Pisum sativum L. ssp. sativum var. arvense) Scientific Alternate Names: Pisum arvense L., Pisum humile Boiss. & Noe, Pisum sativum L. ssp. arvense (L.)Poir., Pisum sativum L. var. arvense(L.) Poir., Pisum sativum L. var .humile Poir., Pisum sativum L. var. macrocarpon Ser., Pisum sativum L. ssp. sativum, and Pisum sativum L. ssp. sativum var. arvense (L.) Poir. D. Basis for GRAS Determination The Notifier is submitting notification to the FDA that it has concluded the intended use of pea protein as an ingredient in human food products is Generally Recognized as Safe (GRAS) based on scientific procedures as described in 21 C.F.R. § 170.30(b). The content of this submission, as described herein, demonstrates that pea protein is GRAS for the intended use as a human food and/or food ingredient based on estimated exposure under the intended conditions of use which shows a level of use consistent with with prior GRAS notices for similar notified substances and literature pertaining to the safety of pea based protein. Burcon NutraScience Corporation Page 005 of 270 Pea Protein GRAS Notice E. Exemption from Food Additive Petition Based on the information contained herein the