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(35% Docosahexaenoic Acid) from Schizochytrium Sp. Strain FCC-1324, Libourne, France: Fermentalg]

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(35% Docosahexaenoic Acid) from Schizochytrium Sp. Strain FCC-1324, Libourne, France: Fermentalg] GRAS Notice (GRN) No. 843 https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory FEB 11 2019 OFFICE OF FOOD ADDITIVE SAFETY Ferment 01 February 2019 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 Re: DHA Algal Oil from Schizochytrium sp. FCC-1324 for Use in Select Food Categories Dear Sir or Madam: 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, Fermentalg, that DHA 350 from Schizochytrium sp. strain FCC-1324 is Generally Recognized as Safe {GRAS) under the intended conditions of use described in the Notice. The Notice is contained in a binder. In addition, we have included a CD that contains a complete copy of the Notice. I hereby certify that the electronic files contained on the CD were scanned for viruses prior to submission, and thus certified as being virus-free using Symantec Endpoint Protection. (b) (6) Sincere! , (b) (6) I / I I l \ \. Tel.+ 33 (0)5 57 250 220- www.fermentalg.com - 4, rue riviere - 33500 Libourne - FRANCE ')ociete anonyme au capital de 685 805.40 euros - 509 935151 RCS Libo11rne - APE 7211Z GRAS Notice for DHA Algal Oil from Schizochytrium sp. FCC-1324 for Use in Select Food Categories PREPARED FOR: 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 USA PREPARED BY: Fermentalg 4 Rue Rivière, 33500 Libourne France DATE: 01 February 2019 GRAS Notice for DHA Algal Oils from Schizochytrium sp. FCC-1324 for Use in Select Food Categories TABLE OF CONTENTS Part 1. §170.225 Signed Statements and Certification ..................................................................................... 3 1.1 Name and Address of Notifier .................................................................................................. 3 1.2 Common Name of Notified Substance ..................................................................................... 3 1.3 Conditions of Use ...................................................................................................................... 3 1.4 Basis for GRAS ........................................................................................................................... 4 1.5 Availability of Information ........................................................................................................ 5 1.6 Freedom of Information Act, 5 U.S.C. 552 ................................................................................ 5 Part 2. §170.230 Identity, Method of Manufacture, Specifications, and Physical or Technical Effect ............. 6 2.1 Description ................................................................................................................................ 6 2.1.1 Chemical Name ............................................................................................................ 6 2.1.2 Molecular Formula....................................................................................................... 6 2.1.3 Chemical Abstract Service (CAS) Number .................................................................... 6 2.1.4 Chemical Structure ...................................................................................................... 6 2.2 Source Organism ....................................................................................................................... 7 2.2.1 Phenotypic Identity ...................................................................................................... 7 2.3 Manufacturing .......................................................................................................................... 9 2.4 Product Specifications and Batch Analyses ............................................................................ 11 2.4.1 Proposed Product Specifications ............................................................................... 11 2.4.2 Microbiological Specifications ................................................................................... 12 2.4.3 Batch Analyses ........................................................................................................... 13 2.4.4 Additional Analytical Information .............................................................................. 14 2.5 Stability ................................................................................................................................... 16 Part 3. §170.235 Dietary Exposure .................................................................................................................. 18 3.1 History of Use in Food ............................................................................................................. 18 3.2 Estimated Consumption of DHA 350 ...................................................................................... 18 3.2.1 Estimated Consumption from Intended Conditions of Use in Food .......................... 18 Part 4. §170.240 Self-Limiting Levels of Use ................................................................................................... 18 Part 5. §170.245 Experience Based on Common Use in Food Before 1958 ................................................... 18 Part 6. §170.250 Narrative and Safety Information ........................................................................................ 18 6.1 Introduction ............................................................................................................................ 18 6.2 Literature Search..................................................................................................................... 19 6.3 Toxicology Studies .................................................................................................................. 19 6.4 Updated Discussion of Safety ................................................................................................. 25 6.5 Clinical Safety .......................................................................................................................... 25 6.6 Expert Panel Evaluation .......................................................................................................... 26 6.7 Conclusions ............................................................................................................................. 26 Fermentalg 01 February 2019 1 Part 7. §170.255 List of Supporting Data and Information ............................................................................. 27 List of Appendices Appendix 1 Safety and Suitability for Use in USDA Regulated Products Appendix 2 Processing Aid Certificates Appendix 3 Certificates of Analysis Appendix 4 Comparative Fatty Acid Analysis Appendix 5 Expert Panel Consensus Statement List of Figures and Tables Figure 2.2.1-1 Phylogeny of Aurantiochytrium, Schizochytrium, Sicyiodochytrium, and Thraustochytrium Genera, Collectively Referred to as Schizochytrium ................................... 8 Figure 2.3-1 Schematic of the Production Process of DHA 350 .................................................................. 10 Table 1.3-1 Summary of the Individual Proposed Food-Uses and Use-Levels for DHA 350 in the United States (U.S.) ................................................................................................................... 4 Table 2.2.1-1 Components of Fermentation Medium for FCC-1324 .............................................................. 9 Table 2.4.1-1 Chemical Specifications for DHA 350 ...................................................................................... 12 Table 2.4.2-1 Microbiological Specifications for DHA 350............................................................................ 12 Table 2.4.3-1 Summary of the Chemical Product Analysis for 3 Lots of DHA 350 ........................................ 13 Table 2.4.3-2 Summary of the Microbiological Product Analysis for 3 Lots of DHA 350 ............................. 13 Table 2.4.4-1 Fatty Acid Profile of DHA 350 ................................................................................................. 14 Table 2.4.4-3 Comparative Sterol Profile ...................................................................................................... 16 Table 2.5-1 Stability of DHA 350 Under Accelerated Storage Conditions ................................................. 16 Table 6.3-1 Safety Data for Schizochytrium sp. algae ................................................................................ 20 Table 6.3-2 Safety Data for DHA-rich Oil from Schizochytrium ................................................................. 21 Fermentalg 01 February 2019 2 GRAS Notice for DHA Algal Oil from Schizochytrium sp. FCC-1324 for Use in Select .Food Categories Part 1. §170.225 Signed Statements and Certification In accordance with 21 CFR § 170 Subpart E consistjng ·of §§ 170.203 through 170.285 (U.S. FDA, 2017a), Fermentalg hereby informs the United States (U.S.) Food and Drug Administration (FDA) that docosahexaenoic acid (DHA) algal oil derived from Schizochytrium sp. FCC-1324 (referred to as DHA 350 herein), manufactured by Fermentalg, is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act based on Fermentalg's view that the notified substance is Generally
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