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GRAS Notice 855, Bifidobacterium Animalis Subsp. Lactis Strain R0421

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GRAS Notice 855, Bifidobacterium Animalis Subsp. Lactis Strain R0421 GRAS Notice (GRN) No. 855 https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory JHeimbach LLC April 3, 2019 Paulette Gaynor, Ph.D. Senior Regulatory Project Manager Division of Biotechnology and GRAS Notice Review (HFS-255) Office of Food Additive Safety Center for Food Safety and Applied Nutrition Food and Drug Administration 5100 Paint Branch Parkway College Park, MD 20740 Dear Dr. Gaynor: Pursuant to 21 CFR Part 170, Subpart E, Lallemand Health Solutions (Lallemand), through me as its agent, hereby provides notice of a claim that the addition to non-exempt milk-based term infant formula of Bifidobacteriurn anirnalis ssp. lactis strain R0421 is exempt from the premarket approval requirement of the Federal Food, Drug, and Cosmetic Act because Lallemand has determined that the intended use is generally recognized as safe (GRAS) based on scientific procedures. As required, one copy of the GRAS monograph and one signed copy of the statement of the Expert Panel are provided. Additionally, I have enclosed a virus-free CD-ROM with the GRAS monograph and the signed statement of the Expert Panel. If you have any questions regarding this notification, please feel free to contact me at 804-742-5543 o~ jheimbach.com. Si11~1/ ""James t. Heimbach, Ph.D., F.A.C.N. President Encl. ~~~~u~~lg) APR 8 2019 OFFICE OF 923 Water Street, P.O. Box 66, Port Royal Virginia 22535, USA FOOD ADDITl\/1: SAFETY tel. (+1) 804-742-5543 fax (+1) 202-478-0986 [email protected] LALLEMAND HEALTH SOLUTIONS Generally Recognized as Safe (GRAS) Determination for the Use of Bifidobacterium animalis subsp. lactis R0421 (LAFTI® B94) Prepared by: LALLEMAND HEALTH SOLUTIONS Regulatory Affairs 17975 rue des Gouverneurs Mirabel, Québec, Canada J7J 2K7 Tel (450) 433-9139 And JHeimbach LLC 923 Water Street Port Royal VA 22535 USA Tel (804) 742-5543 - C O N F I D E N T I A L - 1 LALLEMAND HEALTH SOLUTIONS TABLE OF CONTENTS LIST OF TABLES .............................................................................................................................................. 4 LIST OF FIGURES ............................................................................................................................................ 5 PART 1. SIGNED STATEMENTS AND CERTIFICATION .................................................................................... 6 1.1. GRAS NOTICE SUBMISSION ..................................................................................................................... 6 1.2. NAME AND ADDRESS OF NOTIFIER ............................................................................................................ 6 1.3. NAME OF NOTIFIED ORGANISM ................................................................................................................ 7 1.4. INTENDED CONDITIONS OF USE ................................................................................................................ 7 1.5. STATUTORY BASIS FOR GRAS STATUS ........................................................................................................ 7 1.6. PREMARKET EXEMPT STATUS ................................................................................................................... 7 1.7. AVAILABILITY OF INFORMATION ................................................................................................................ 7 1.8. FREEDOM OF INFORMATION ACT STATEMENT ............................................................................................. 7 1.9. CERTIFICATION ....................................................................................................................................... 7 1.10. FSIS STATEMENT ................................................................................................................................. 8 1.11. NAME AND TITLE OF SIGNER .................................................................................................................. 8 PART 2. IDENTITY, METHOD OF MANUFACTURE, SPECIFICATIONS, AND TECHNICAL EFFECT ..................... 9 2.1. NAME OF THE GRAS ORGANISM .............................................................................................................. 9 2.2. SOURCE OF THE GRAS ORGANISM ............................................................................................................ 9 2.3. DESCRIPTION OF THE GRAS ORGANISM BIFIDOBACTERIUM ANIMALIS SUBSP. LACTIS R0421 (LAFTI® B94) ......... 9 2.3.1. Phenotypic Identification of B. animalis subsp. lactis Rosell®-421(LAFTI® B94)...................... 11 2.3.1.1. Morphology ...................................................................................................................... 11 2.3.1.2. Gram Stain Reaction ......................................................................................................... 12 2.3.1.3. Biochemical Testing .......................................................................................................... 12 2.3.2. Genotypic identification of Bifidobacterium animalis subsp. lactis Rosell®-421 (LAFTI® B94) 13 2.3.2.1. Pulse Field Gel Electrophoresis (PFGE) ............................................................................. 13 2.3.2.2. Multi-Locus Sequence Typing (MLST) ............................................................................... 15 2.3.2.3. Random Amplification of Polymeric DNA (RAPD) ............................................................. 16 2.3.2.4. PATRIC database analysis.................................................................................................. 17 2.4. GENOMIC ANALYSIS OF BIFIDOBACTERIUM ANIMALIS SUBSP. LACTIS R0421 (LAFTI® B94).............................. 22 2.4.1. Sequencing ............................................................................................................................... 22 2.4.2. Annotation of the Genome ...................................................................................................... 22 2.4.3. Annotation of the Plasmid ....................................................................................................... 23 2.4.4. Results of the Genomic Analysis .............................................................................................. 23 2.5. PRODUCTION PROCESS OF THE BACTERIAL POWDER ................................................................................... 24 2.6. SPECIFICATIONS OF THE BACTERIAL POWDER ............................................................................................ 28 2.7. HEAVY METALS .................................................................................................................................... 30 2.8. STABILITY OF BACTERIAL POWDER ............................................................................................................ 31 PART 3. DIETARY EXPOSURE (EDI) ............................................................................................................... 32 PART 4: SELF-LIMITING LEVELS OF USE ...................................................................................................... 33 PART 5: EXPERIENCE BASED ON COMMON USE IN FOOD ......................................................................... 34 PART 6: NARRATIVE .................................................................................................................................... 35 6.1. RECOGNIZED SAFETY OF BIFIDOBACTERIA ................................................................................................. 35 6.2. HISTORY OF CONSUMPTION OF BIFIDOBACTERIUM ANIMALIS SUBSP. LACTIS ROSELL®-421 (LAFTI® B94) .......... 36 6.3. SAFETY PARAMETERS ............................................................................................................................ 37 6.3.1. Ability to Adhere to Intestinal Cells .......................................................................................... 37 2 LALLEMAND HEALTH SOLUTIONS 6.3.2. Infectivity .................................................................................................................................. 38 6.3.3. Undesirable Metabolic Activity ................................................................................................ 39 6.3.3.1 D-Lactate Production ......................................................................................................... 39 6.3.3.2. Bile Salt Deconjugase Activity ........................................................................................... 39 6.3.4. Presence of Antibiotic Resistances Genes and Likelihood of transference ............................. 40 6.3.4.1. Minimal Inhibitory Concentrations ................................................................................... 40 6.3.4.2. DNA Microarrays ............................................................................................................... 42 6.3.4.3. Antibiotic Production ........................................................................................................ 43 6.3.5. Bioavailability of Bifidobacterium animalis subsp. lactis Rosell®-421 (LAFTI® B94) ................ 44 6.3.5.1. Resistance to Acidity and Bile ........................................................................................... 44 6.3.5.2. Persistency of the strain in the gastrointestinal tract ...................................................... 46 6.4. HUMAN STUDIES .................................................................................................................................
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