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GRAS Notice 913, Algal Oil (Minimum 35% DHA)

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GRAS Notice 913, Algal Oil (Minimum 35% DHA) GRAS Notice (GRN) No. 913 https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory Tox• Strategi.es Innovative solutions Sound science February 21 , 2020 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 Subject: GRAS Notification - DHA Algal Oil Dear Sir: On behalf of Mara Renewables Corporation, ToxStrategies, Inc. (its agent) is submitting, for FDA review, a copy of the GRAS notification as required. The enclosed document provides notice of a claim that the food ingredient, DHA algal oil, described in the enclosed notification is exempt from the premarket approval requirement of the Federal Food, Drug, and Cosmetic Act because it has been determined to be generally recognized as safe (GRAS), based on scientific procedures, for addition to food. If you have any questions or require additional information, please do not hesitate to contact me at 630-352-0303, or [email protected]. Sincerely, <---------- Donald F. Schmitt, M.P.H. Senior Managing Scientist FEB 2 5 2020 OFFICE OF FOOD ADDITIVE SAFETY · ToxStrategies, Inc., 931 W. 75111 St. , Suite 137, PMB 255. Naperville, IL 60565 Office (630) 352-030 • www.toxstrategies.com GRAS Determination of DHA Algal Oil for Use in Foods FEBRUARY 7, 2020 Innovative solutions Sound science GRAS Determination of DHA Algal Oil for Use in Foods SUBMITTED BY: Mara Renewables Corporation !OJA Research Drive Dartmouth, NS B2Y 4T6 Canada SUBMITTED TO: U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Food Additive Safety 5100 Campus Drive College Park MD 20740-3835 CONTACT FOR TECHNICAL OR OTHER INFORMATION Donald F. Schmitt, MPH ToxStrategies, Inc. 931 W. 75tli St., Suite 137, PMB 255 Naperville, IL 60565 FEBRUARY 7, 2020 2 Table of Contents Acronyms ............................................................................................................................ 6 § 170.225 Part 1, GRAS Notice: Signed Statements and Certification ......................... 7 (1) GRAS Submission .••.•.........................................•...•..•.................................•........... 7 (2) Name and Address .................................................................................................. 7 (3) Name of Notified Substance ................................................................................... 7 (4) Intended Use in Food .............................................................................................. 7 (5) Statutory Basis for GRAS Determination ............................................................. 7 (6) Premarket Approval Statement ............................................................................. 7 (7) Availability of Information..................................................................................... 8 (8) Data and Information Confidentiality Statement ................................................ 8 (9) GRAS Certification ................................................................................................. 8 (10) Name/Position of Notifier ..................................................................................... 8 (11) FSIS Statement ...................................................................................................... 8 § 170.230 Part 2, Identity, Method of Manufacture, Specifications, and Physical or Technical Effect .............................................................................................. 9 Identity ....•..••........................................•.•..••.•.............................•.............................•..... 9 Empirical Formula and Chemical Structure of DHA ................................................ 9 Common or Chemical Names ...................................................................................... 9 Characterization of Strain ........................................................................................... 9 Manufacturing Process ............................................................................................... 11 Degumming/Alkali Refining (Optional) .. 14 Bleaching. 15 D rodorization. 15 Product Specifications ................................................................................................ 17 Stability Data ............................................................................................................... 24 § 170.235 Part 3, Dietary Exposure ................................................................................ 26 § 170.240 Part 4, Self-Limiting Levels of Use ................................................................ 29 § 170.245 Part 5, Experience Based on Common Use in Food .................................... 30 § 170.250 Part 6, GRAS Narrative ............................................•................................... .31 History of Use/Regulatory Approval of DHA-Algal Oil.....•.................................... 31 Safety ............................................................................................................................ 33 3 Toxicological Studies. 33 Safety Data Summary ................................................................................................. 37 Basis for the GRAS Determination ........................................................................... 38 Introduction ............................................................................................................... 38 Safety Determination .................................................................................................. 39 General Recognition of the Safety of DHA-Algal Oil.. ............................................ 40 § 170.250 Part 7, Supporting Data and Information .................................................... 43 References ........................•........................................................................................... 43 Appendix A. Certificates of Analysis/Algal Toxin Analysis Exhibit 1 Expert Panel Report 4 List of Figures Figure 1. Struch1ral formula ofDHA ................................................................................. 9 Figure 2. Genus Schizochy1ri11111 description .................................................................... 10 Figure 3. DI-IA-algal oil manufacturing proccss ............................................................... 11 Figure 4. DI·IA-algal oil refining process ......................................................................... 14 List of Tables Table 1. Fermentation medium ingredients ..................................................................... 12 Table 2. Reagents/processing aids ................................................................................... 17 Table 3. Specifications for DH A-algal oil from Schizochytriwn sp. G3 ......................... 17 Table 4. Analytical results for three non-consecutive lots of Mara DHA-algal oil produced using Schiwchytrium sp. G3 compared to FCC specifications and a representative lot ofGRN 677 Mara DHA-algal oil. ............................... 19 Table 5. Proximate analysis of three non-consecutive lots of Mara DHA-algal oil produced using Schizochytrium sp. G3 .............................................................. 20 Table 6. Fatty acid profile (area%) of three non-consecutive lots of Mara DHA- algal oil produced using Schizochytrium sp. G3 ................................................ 2 l Table 7. Sterol content(% total sterols) of three non-consecutive lots of Mara DHA-algal oil produced using Schizochvtrium sp. G3 ...................................... 22 Table 8. Select analytical results for residual contaminants* .......................................... 23 Table 9. Algal toxin analysis* ......................................................................................... 24 Table 10. Accelerated stability study of Mara DHA-algal oil produced using Schizochytrium sp. G3 ...................................................................................... .25 Table 11. Approved use levels of menhaden oil (DHA+EPA) compared to proposed maximum use levels of Mara's DI-IA-algal oil* in food ................... 27 Table 12. Regulatory approvals for use of DHA in food and infant formula ................... 31 Table 13. Summary of preclinical toxicological study data on DI-IA-rich algal oilT!S ............................................................................................................... 35 5 Acronyms CAS Chemical Abstracts Service CFR Code of Federal Regulations CFU colony-forming unit cGMP current Good Manufacturing Practices COA Certificate of Analysis DHA docosahexaenoic acid DHASCO docosahexaenoic acid single cell oil EC European Commission EFSA European Food Safety Authority EPA eicosapentaenoic acid EU European Union Organization FCC Food Chemicals Codex FDA U.S. Food and Drug Administration FR Federal Register FSIS Food Safety and Inspection Service GMP Good Manufacturing Practice GRAS Generally Recognized as Safe GRN GRAS Notification HACCP Hazard Analysis Critical Control Point IOM Institute of Medicine JECFA Joint FAO/WHO Expert Committee on Food Additives NOAEL no-observed-adverse-effect level ONC Ocean Nutrition Canada Limited PUFA polyunsaturated fatty acids RBD Refined, bleached, deodorized QC quality control UL tolerable upper intake level USDA U.S. Department of Agriculture WHO World Health Organization 6 § 170.225 Part 1, GRAS Notice: Signed
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