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GRAS Notice 864, Bacillus Coagulans SNZ 1969 Spore Preparation

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GRAS Notice 864, Bacillus Coagulans SNZ 1969 Spore Preparation GRAS Notice (GRN) No. 864 https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory 749 46th Square Vero Beach, FL 32968, USA Telephone: 772-299-0746 Soni & Associates Inc. Facsimile: 772-299-5381 E-mail: [email protected] May 21, 2019 Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Food Additive Safety (HFS-200) 5100 Campus Drive College Park, MD 20740 Subject: GRAS Notification for the intended use of Bacillus coagulans SNZ 1969 spores preparation in Infant Formula Dear Sir/Madam: In accordance with 21 CFR part 170, subpart E, Sanzyme Biologics Pvt. Ltd., through Soni & Associates Inc. as its agent, hereby submits the enclosed notice of a claim that the food ingredient Bacillus coagulans SNZ 1969 spores preparation for use in infant formula as described in the enclosed notification document is exempt from the premarket approval requirement of the Federal Fo~ Drug, and Cosmetic Act because it has been determined to be Generally Recognized As Safe (GRAS), based on scientific procedures. As required, please find enclosed three copies of the notification. If you have any questions or require additional information, please feel free to contact me by phone at + 1-772- 299-0746 or by email at [email protected]. Sincerely, _ - Madhu G. Soni, PhD, FACN, FATS Agent for Sanzyme Biologics Pvt. Ltd. INDIA Enclosure: Three copies of GRAS notification www .soniassociates.net GENERALLY RECOGNIZED AS SAFE (GRAS) EVALUATION OF BACILLUS COAGULANS SNZ 1969 FOR USES IN TERM INFANT FORMULA Submitted by: Sanzyme Biologics Pvt. Limited Plot No. 13, Sagar Society Banjara Hills, Road Number 2 Hyderabad - 500 034, Telengana INDIA Submitted to: U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Food Additive Safety HFS-200 5100 Campus Drive College Park, MD 20740 USA Contact for Technical and Other Information Madhu G. Soni, PhD Soni & Associates Inc. 749 46th Square Vero Beach, FL 32968 May 08, 2019 GENERALLY RECOGNIZED AS SAFE (GRAS) EVALUATION OF Bacillus coagulans SNZ 1969 FOR USES IN TERM INFANT FORMULA TABLE OF CONTENTS 1. Part 1.- SIGNED STATEMENTS AND CERTIFICATION .... ;.......................................... 4 1.1. Name and Address of Notifier ...................................................................................... 4 1.2. Name of Notified Substance .......................................................................................... 4 1.3. Intended Conditions of Use ........................................................................................... 4 1.4. Statutory Basis for GRAS Determination ................................................................... 5 1.5. Exclusion from Premarket Approval ........................................................................... 5 1.6. Availability of Data & Information .............................................................................. 5 1. 7. Data Exemption from Disclosure ................................................................................. 5 1.8. Certification .................................................................................................................... 6 1.9. Name, Position/Title of Responsible Person who Signs the Dossier and Signature. 6 1.10. FSIS/USDA - Use in Meat and/or Poultry .................................................................. 6 2. Part 2 -IDENTITY, SPECIFICATION AND MANUFACTURING ................................. 7 2.1. Identity ............................................................................................................................ 7 2.1.1. Name and Source of GRAS Organism ......................................................................... 7 2.1.2. Description of GRAS Organism ................................................................................... 7 2.1.3. Identification and Characterization ............................................................................. 8 2.1.3.1. Phenotypic Identification .............................................................................................. 8 2.1.3.2. Genotypic Identification ................................................................................................ 9 2.1.3.2.1. Genomic DNA isolation and quality assessment. ....................................................... 9 2.1.3.2.2. rRNA gene PCR and phylogenetic analysis ............................................................... 9 2.1.3.2.3. Whole Genome Sequencing ........................................................................................ 11 2.1.4. Manufacturing Process ................................................................................................ 12 2.1.4.1. Seed Media Preparation .............................................................................................. 12 2.1.4.2. Seed Inoculation and Culture Growth ....................................................................... 12 2.1.4.3. Sterilization, Fermentation and Separation .............................................................. 13 2.1.4.4. Drying, Sifting, Blending, Packaging ......................................................................... 13 Sanzyme Page 2 of60 B. coagu/ans GRAS-IF 2.2. Specifications···················.····························································································· 14 3. Part III - DIETARY EXPOSURE ....•............•............•...........•...........•......•.............•......••.... 16 3.1. Intended Use Levels and Food Categories ................................................................. 16 3.1.1. Estimated Daily Intake from the Proposed Uses ...................................................... 16 4. Part IV - SELF LIMITING LEVELS OF USE ................................................................... 18 5. Part V - EXPERIENCE BASED ON COMMON USE IN FOODS BEFORE 1958 ....... 19 6. Part VI - NARRATIVE ........•............•.•.......................•...........•........•.........•.......•.....•.•........•. 20 6.1. Data Pertaining to Safe Uses .............•........•........................•..•..........•...............•...•.•... 20 6.1.1. Traditional Uses .........•................•........•......••...•..................•............................•.....•..... 20 6.1.2. Current Uses and Regulatory Status.......................................................................... 20 6.2. Safety Related Studies ..•.•...............................................•........................•...........•....... 23 6.2.1. Studies in Infants and Children •..•..•........•••...•.•..•.•.•.••.....•....•..•.••.•.•.•...•.••••.•......••.•.••• 23 6.2.2. Human Studies with Labcon (Mother strain of SNZ 1969) ..................................... 26 6.2.3. Studies in Adult Human Subjects .••.•........•......•.......•.•••.....••.•...•••....•.••.•••.•.•.......•....•.. 27 6.2.4. Safety Based on Genome Sequencing......................................................................... 35 6.2.5. Specific Antibiotic Susceptibility Studies .................................................................. 36 6.2.6. Specific Antimicrobial Action Studies ....................................................................... 37 6.2.7. Specific Bile Salt and Acid Tolerance Studies ........................................................... 38 6.2.8. Animal Toxicity Studies .............•.....................................••.....•.........•.............•.•........•. 38 6.3. Expert Panel Review, Summary and Discussion ...................................................... 44 6.4. Expert Panel Conclusion ..................................................•......................................•... 48 7. Part VII - SUPPORTING DATA AND INFORMATION ................................................. 49 Sanzyme Page 3 of60 B. coagu/ans GRAS-IF 1. Part I - SIGNED STATEMENTS AND CERTIFICATION 1.1. Submission of GRAS Notice In accordance with 21 CFR § 170 Subpart E consisting of§ 170.203 through § 170.285, Sanzyme Biologics Pvt. Ltd., (Sanzyme Biologics) hereby informs the FDA that Bacillus coagulans SNZ 1969 spores preparations manufactured by Sanzyme Biologics, is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act based on Sanzyme Biologics' view that the notified substance is Generally Recognized as Safe (GRAS) under the conditions of its intended use described in Section 1.3 below. It should be noted that the subject of the present GRAS assessment, B. coagulans SNZ 1969 spore preparation, for use in term infant formula is identical to that of Sanzyme Ltd. 1 (the parent company Sanzyme Biologics) GRAS notice (GRN 597) that received a "no question letter" from FDA for the use of Bacillus coagulans SNZ 1969 spores preparation in conventional foods. 1.2. Name and Address of Notifier Sanzyme Biologics Pvt. Limited Plot No. 13, Sagar Society Banjara Hills, Road Number 2 Hyderabad - 500 034, Telengana INDIA 1.3. Name of Notified Substance The common name of the substance of this GRAS assessment is Bacillus coagulans SNZ 1969 spores preparation for uses in term infant formula will be marketed as standardized powder. 1.4. Intended Conditions of Use Bacillus coagulans SNZ 1969 spore preparation (B. coagulans) is intended for use as an ingredient in non-exempt term infant formula at the maximum intended addition levels of 2xl 08 colony forming units (cfu) per 100 mL infant formula as ready for consumption. B. coagulans is not intended for addition
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