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GRAS Notice 851, Pea Protein GRAS Notice (GRN) No. 851 https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory 1001 G Street, N.W. Suite 500 West Washington, D.C. 20001 tel. 202.434.4100 fax 202.434.4646 Writer's Direct Access Evangelia C. Pelonis (202) 434-4 l06 pe I on i s@k h I aw. com January 28, 2019 Via FedEx & CD-ROM . Dr. Susan Carlson Director, Division of Biotechnology and GRAS Notice Review Office of Food Additive Safety (HFS-200) Center for Food Safety and Applied Nutrition Food and Drug Administration 5100 Paint Branch Parkway College Park, MD 20740-3835 Re: GRAS Notification for Roquette Freres Pea Protein Isolate Dear Dr. Carlson: We respectfully submit the attached GRAS Notification on behalf of our client, Roquette Freres (Roquette) for pea protein isolate to be used as a concentrated, highly digestible protein source in various food categories (excluding infant formula) and as a binder and extender in meat and poultry products. The pea protein isolate will be used as a substitute for, and/or in conjunction with, other proteins in conventional food products, as well as in meal replacement and dry blend protein powder applications. Thus, the pea protein isolate will not contribute any additional exposure to protein and it is not intended to be used to replace the entire daily protein intake or as the sole source of protein in the diet for consumers. More detailed information regarding product identification, intended use levels, and the manufacturing and safety of the ingredient is set forth in the attached GRAS Notification. Roquette has determined that their pea protein isolate is GRAS based on scientific procedures in accordance with 21 C.F.R. § 170.30(b) and in conformance with the guidance issued by the Food and Drug Administration (FDA) under 21 C.F.R. § 170.36, 81 Fed. Reg. 54960 (Aug. 17, 2016). Therefore, the use of the pea protein isolate as described in this GRAS Notification is exempt from the requirement of premarket approval as set forth in the Federal Food, Drug, and Cosmetic Act. The analytical data, published studies, and information that are the basis for this GRAS Notification are available for FDA review and copying at reasonable times at Keller and _______W~as~h_in~g~to~"~· D~.C~.'----B_r=us'-'--se'-'-'--1s ----'-'Sa=n--'-F-'-'ra""nc-'-'-isc...cco~ - -~Sh= =an=g =ha"'-i- ---'P-"'a'--'-'ris'---------­ Thls document was delivered electronically. WW\\.l,.hlaw.com KELLER AND HECKMAN LLP Dr. Susan Carlson January 28, 2019 Page 2 Heckman LLP, 1001 G Street, NW, Suite 500W, Washington, DC 20001, or will be sent to FDA upon request. We look forward to the Agency’s review of this submission and would be happy to provide Agency officials with any information they may need to complete their assessment. Thank you for your attention to this matter. Sincerely, Evangelia C. Pelonis This document was delivered electronically. GRAS Notification for Roquette's Pea Protein Isolate Prepared for: U.S. Food and Drug Administration Office of Food Additive Safety (HFS-200) Center for Food Safety and Applied Nutrition 5100 Paint Branch Parkway College Park, MD 20740-3835 Submitted by: Keller and Heckman LLP 1001 G Street, NW Suite 500W Washington, DC 20001 Date: January 28, 2019 ~~cc~u~~lQ) J~2019 '('( l'rR 1,. '5 ' OFFICE OF FOOD ADDITIV'c SAFETY GRAS Notice for Pea Protein Isolate Table of Contents Part 1 – Signed statements and certification ................................................................................... 1 (1) Applicability of 21 C.F.R. part 170, subpart E ..................................................................... 1 (2) Name and address of the notifier .......................................................................................... 1 (3) Name of the notified substance ............................................................................................ 1 (4) Applicable conditions of use of the notified substance ........................................................ 1 (5) Basis for the GRAS determination ....................................................................................... 2 (6) Exclusion from premarket approval ..................................................................................... 2 (7) Availability of data and information .................................................................................... 3 (8) Applicability of FOIA exemptions ....................................................................................... 3 (9) FSIS/USDA – Use in Meat and/or Poultry ........................................................................... 3 (10)Certification .......................................................................................................................... 3 Part 2 – Identity, method of manufacture, specifications, and physical or technical effect ............ 5 (1) Identity of the notified substance .......................................................................................... 5 (a) Chemical and physical properties ...................................................................................... 5 (b) Amino acid analyses .......................................................................................................... 5 (2) Description of the method of manufacture ........................................................................... 6 (3) Specifications and identity ................................................................................................... 9 (a) Nutralys® Pea Protein Isolate Variations .......................................................................... 9 (4) Stability Data ...................................................................................................................... 14 (5) Contaminants ...................................................................................................................... 16 Part 3 – Dietary exposure .............................................................................................................. 18 (1) Estimate of dietary exposure .............................................................................................. 18 Part 4 – Self-limiting levels of use ................................................................................................ 20 Part 5 – Experience based on common use in food before 1958 .................................................. 21 Part 6 – Narrative .......................................................................................................................... 22 (1) Introduction ........................................................................................................................ 22 (2) Existing Clearances for Pea Protein ................................................................................... 22 (3) Safety of Pea ....................................................................................................................... 23 (a) Anti-Nutrient Factors (ANFs) in Peas ............................................................................. 23 (b) Protein Quality and Digestibility ..................................................................................... 29 (4) Safety of Pea Protein Isolate ............................................................................................... 33 (a) Animal Nutritional Studies on Pea Protein...................................................................... 33 (b) Animal Safety Studies on Nutralys® Pea Protein Isolate ................................................ 34 (c) Summary of Safety Studies .............................................................................................. 39 (d) Pea Allergenicity.............................................................................................................. 39 (e) Conclusions ..................................................................................................................... 40 LIST OF TABLES AND FIGURES Figure 1: Pea Protein Isolate General Manufacturing Diagram Table 1: Comparison of Amino Acids of Pea and Roquette’s Nutralys® Pea Protein Isolate Table 2: Nutritional Composition of Roquette’s Pea Protein Isolate Table 3: Product Specifications for Roquette’s Pea Protein Isolate Table 4: Analysis of Three Non-Consecutive Lots of Pea Protein Isolate, S85F Table 5: Analysis of Three Non-Consecutive Lots of Pea Protein Isolate, F85F Table 6: Analysis of Three Non-Consecutive Lots of Pea Protein Isolate, S85Plus Table 7: Stability Data for Nutralys® S85Plus Table 8: Contaminant Analysis for S85F Lot# Table 9: Contaminant Analysis for F85F Lot# Table 10: Contaminant Analysis for S85Plus Lot# Table 11: List of Proposed Food Uses and Use-Levels for Roquette’s Pea Protein Isolate Table 12: GRAS Notices for Pea Ingredients Table 13: Reduction in Anti-Nutrient Factors (ANF) of Pea Protein Isolate Table 14: Amino Acid Content in Roquette’s Pea Protein Isolate (Nutralys® S85M) Table 15: Mean and Standard Deviation for Total Digestibility (TD) Values Part 1 – Signed statements and certification (1) Applicability of 21 C.F.R. part 170, subpart E We submit this generally recognized as safe (GRAS) notice in accordance with proposed 21 C.F.R. part 170, subpart E consisting of sections 170.203 through 170.285. (2) Name and address of the notifier Roquette Freres Batiment Alpha 3 Lestrem 62080 FRANCE All communications on this matter are to be sent to Counsel for the Notifier Evangelia C. Pelonis Keller and Heckman LLP 1001 G Street, NW Suite 500W Washington
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