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GRAS Notice 956, Bacillus Subtilis PLSSC

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GRAS Notice 956, Bacillus Subtilis PLSSC GRAS Notice (GRN) No. 956 https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory JHeimbach LLC RECE\VED June 4, 2020 __l ' : · ) ' ' ·. ·:~1 OFFICE Or FOOD ADDITIVE SAFETY Susan J. Carlson, Ph.D., Director Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition Food and Drug Administration 5001 Campus Dr., College Park, MD 20740 Dear Dr. Carlson: Pursuant to 21 CFR Part 170, Subpart E, Advanced Enzymes Techologies, Ltd., through me as its agent, hereby provides notice of a claim that the addition of Bacillus subtilis strain PLSSC to conventional foods is exempt from the premarket approval requirement of the Federal Food, Drug, and Cosmetic Act because Advanced Enzymes Techologies, Ltd., has determined that the intended use is generally recognized as safe (GRAS) based on scientific procedures. A CD is enclosed containing Form 3667, the GRAS monograph, and the signatures of members of the GRAS panel in a zip directory produced through COSM. If you have any questions regarding this notification, please feel free to contact me at 202-320-3063 or [email protected]. ,T~k'D., F.A.C.N. President Encl. 1205 Prince Edward Street, Fredericl:?sburg Virginia 22535, USA tel. (+1) 804-742-5548 cell (+1) 202-320-3063 [email protected] GRAS NOTIFICATION Bacillus subtilis PLSSC (ATCC SD 7280) Advanced Enzyme Technologies Ltd. 5th Floor, ‘A’ wing, Sun Magnetica, L.I.C. Service Road, Louiswadi, Thane (W) – 400 064, INDIA Bacillus subtilis PLSSC enzr_mes 4 nced WhPrP FNlYMF I~ I ifP Table of Contents PART 1. SIGNED STATEMENTS AND CERTIFICATIONS ............................................................................. 3 I. I GRAS NOTICE SUBMISSION .................................................................................................................................... 3 1.2 NAME AND ADDRESS OF NOTIFIER .......................................................................................................................... 3 1.3 NAME OF NOTIFIED MICROORGANISM ..................................................................................................................... 4 1.4 INTENDED CONDITIONS OF USE ............................................................................................................................... 4 1.5 STATUTORY BASIS FOR GRAS STATUS ................................................................................................................... 4 1.6 PREMARKET EXEMPT STATUS .................................................................................................................................. 4 1.7 DATA AVAILABILITY ............................................................................................................................................... 5 1.8 FOIA STATEMENT ................................................................................................................................................... 5 1.9 CERTIFICATION ........................................................................................................................................................ 5 1.1 0 FSIS STATEMENT .................................................................................................................................................... 5 I.I I NAME/POSITION OF NOTIFIER .................................................................................................................................. 5 PART 2. IDENTITY, METHOD OF MANUFACTURE, SPECIFICATIONS, AND PHYSICAL OR TECHNICAL EFFECT ...................................................................................................................................................... 6 2.1 IDENTITY/ IDENTIFICATION ...................................................................................................................................... 6 2.2 MANUFACTURING PROCESS ................................................................................................................................... 15 2.3 PRODUCT SPECIFICATIONS AND COMPOSITIONAL VARIABILITY ............................................................................ 18 2.4 SHELF-LIFE STABILITY .......................................................................................................................................... 20 PART 3: INTENDED USE AND DIETARY EXPOSURE ................................................................................... 21 PART 4: SELF-LIMITING LEVELS OF USE ..................................................................................................... 23 PART 5: EXPERIENCE BASED ON COMMON USE IN FOOD BEFORE 1958 ........................................... 24 PART 6: NARRATIVE ............................................................................................................................................ 25 6.1. HISTORY OF CONSUMPTION OF BACILLUS SUBTILIS ................................................................................................. 25 6.2 REGULATORY HISTORY OF BACILLUS SUBTILIS ....................................................................................................... 25 6.3 SAFETY OF BACILLUS SUBTILIS—ORAL TOXICITY AND GENOTOXICITY STUDIES ................................................... 26 6.4 SAFETY OF BACILLUS SUBTILIS —HUMAN STUDIES ................................................................................................ 29 6.5 DECISION TREE ...................................................................................................................................................... 33 6.6 SAFETY ASSESSMENT AND GRAS DETERMINATION .............................................................................................. 34 6.8. STATEMENT OF THE GRAS PANEL ............................................................................................................................. 36 PART 7: REFERENCES ......................................................................................................................................... 37 BSP/2020/AETL/Ver.1.0 2 Bacillus subtilis PLSSC enzr_mes 4 nced WhPrP FNlYMF I~ I ifP Part 1. Signed Statements and Certifications 1.1 GRAS Notice Submission Advanced Enzymes Technologies Ltd. submits this GRAS notice through its agent James T. Heimbach, president of JHeimbach LLC, in accordance with 21 CFR part 170, subpart E. 1.2 Name and Address of Notifier APPLICANT Name: Advanced Enzyme Technologies Ltd. Address: 5th Floor, ‘A’ wing, Sun Magnetica LIC Service Road, Louiswadi Postal code and City: Thane (W), India 400604 Country: India Tel. no: +91 22 41703200 Fax no: +91 22 25835159 E-mail: [email protected] MANUFACTURER Name: Advanced Enzyme Technologies Ltd. Address: 5th Floor, ‘A’ wing, Sun Magnetica LIC Service Road, Louiswadi Postal code and City: Thane (W), India 400604 Country: India Tel. no: +91 22 41703200 Fax no: +91 22 25835159 PERSON RESPONSIBLE FOR THE DOSSIER Name: Dr. Anil Kumar Gupta VP – Research & Development Address: Advanced Enzyme Technologies Ltd. 5th Floor, ‘A’ wing, Sun Magnetica LIC Service Road, Louiswadi Postal code and City: Thane (W), India 400604 Country: India Tel. no: +91 22 25830284 E-mail: [email protected] US AGENT Name: James T. Heimbach, Ph.D., F.A.C.N. JHeimbach LLC Address: 923 Water Street #66 Postal code and City: Port Royal, Virginia 22535 County: USA Tel. no: +1 804-742-5543 E-mail: [email protected] BSP/2020/AETL/Ver.1.0 3 Bacillus subtilis PLSSC 4 nced enzr_mes WhPrP FNlYMF I~ I ifP 1.3 Name of Notified Microorganism Bacillus subtilis strain PLSSC is the designation of the proprietary Bacillus subtilis strain of Advanced Enzyme Technologies Ltd. The strain, originally isolated from soil, is deposited at the American Type Culture Collection (ATCC), USA, under strain designation SD-7280. The product Bacillus subtilis PLSSC (SD-7280) is a spore preparation which contains no viable vegetative cells. Commercial preparations of Bacillus subtilis PLSSC (SD-7280) are known as BioSEB BS and SEBtilis. In this GRAS notice, the Bacillus subtilis strain PLSSC is also referred by names such as ‘Bacillus subtilis PLSSC’; ‘B. subtilis PLSSC’ or Bacillus subtilis SD-7280, Bacillus subtilis subspecies subtilis. 1.4 Intended Conditions of Use Based on history of safe use in food and demonstrated safety, Bacillus subtilis PLSSC is intended to be used as food ingredient in the following food categories at a level of approximately 1x106 to 6x109 colony forming units (cfu)/serving: Baked goods and baking mixes, breakfast cereals, beverages and beverage bases, coffee and tea; milk and milk products, dairy product analogs, fruit juices, condiments and relishes, confections and frostings, frozen dairy desserts and mixes, fruit and water ices, drinking water, sports drinks, gelatins, jams and jellies, puddings and fillings; grain products and pastas; hard candy, soft candy, chewing gum, extracts, and flavorings, herbs, seeds, spices, seasonings, blends, nuts and nut products, plant protein products, processed fruits, processed vegetables and vegetable juices, snack foods, soups and soup mixes, sugar and sweet sauces, toppings, and syrups. Based upon the estimated number of servings of food consumed per day in the United States and the highest intended addition level of Bacillus subtilis per serving, the estimated daily intake (EDI) of the strain is 1.1x1011 cfu/day. (This EDI would be reached only if all target foods indeed contained B. subtilis at the maximum addition level.). The intended use of
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