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GRAS Notice 760, Lactobacillus Curvatus DSM 18775

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GRAS Notice 760, Lactobacillus Curvatus DSM 18775 GRAS Notice (GRN) No. 760 https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory CHRA.HANSEN FEB 8 2018 GR tV 0 <f <i 7 b (j OFFICE OF Chr. Hansen, Inc. FOOD ADDITIVE SAFEl'Y 9015 West Maple Street Milwaukee, WI 53214 - 4298 U.S.A. Division of Biotechnology and GRAS Notice Review Center for Food Safety & Applied Nutrition (HFS-255) Phone 414 - 607 - 5700 Fax 414 - 607 - 5959 U.S. Food & Drug Administration Dr. Rachel Morissette 5100 Campus Drive, College Park, MD 20740 January 31, 2018 Reference: Chr. Hansen GRAS Notification for Lactobacillus curvatus DSM 18775 Dear Dr. Rachel Morissette: In accordance with the Federal Register [81 Fed. Reg. 159 (17 August 2016)] issuance on Generally Recognized as Safe (GRAS) notifications (21 CFR Part 170), Chr. Hansen is pleased to submit a notice that we have concluded, through scientific procedures, the organism Lactobacillus curvatus DSM 18775, is generally recognized as safe and is not subject to the pre-market approval requirements for the use in ready-to-eat cooked meat and poultry products including but not limited to cooked ham, beef, turkey, chicken, emulsified lunch meats, and emulsified sausages to help suppress the growth of Listeria monocytogenes. We also request that a copy of the notification be shared with the United States Department of Agriculture's Food Safety and Inspection Service, regarding the use of Lactobacillus curvatus DSM 18775 as a safe and suitable ingredient in ready-to-eat cooked meat and poultry products. If there are any questions or concerns, please contact us. Yours sincerely, (b) (6) (b) (6) Emily Gre ire Regulatory Affairs Specialist Regional Regulatory Affairs Manager North America CHR. HANSEN, INC. Table f C ntents Part 1: Signed Statements and Certification ................................................................................................. 5 1.1 Statement of Intent................................................................................................................................. 5 1.2 Name and Address of Notifier ................................................................................................................ 5 1.3 Common or Usual Name ......................................................................................................................... 5 1.4 Conditions of Use .................................................................................................................................... 5 1.5 Basis for GRAS etermination ................................................................................................................ 5 1.6 Premarket Approval Status ..................................................................................................................... 5 1.7 Availability of Information ...................................................................................................................... 5 1.8 Freedom of Information Act ................................................................................................................... 6 1.9 Certification ............................................................................................................................................. 6 1.10 Signature ............................................................................................................................................... 6 1.11 FSIS Authorization ................................................................................................................................. 6 Part 2: Identity, Method of Manufacture, Specifications, and Physical or Technical Effect ........................ 7 2.1 Name of the GRAS Organism .................................................................................................................. 7 2.2 Source of the GRAS Organism ................................................................................................................. 7 2.3 escription of the GRAS Organism ......................................................................................................... 7 2.3.1 Phenotypic Characteristics ........................................................................................................... 8 2.3.2 Biogenic Amines ........................................................................................................................... 8 2.3.3 Antibiotic Resistance .................................................................................................................... 9 2.3.4 GM Status ..................................................................................................................................... 9 2.4 Method of Manufacture ......................................................................................................................... 9 2.4.1 Raw Materials and Processing Aids ........................................................................................... 10 2.5 Specifications ........................................................................................................................................ 10 2.6 Intended technical effect & amount required ...................................................................................... 12 2.6.1 Hurdle Technology ..................................................................................................................... 13 2.6.2 Application and Plant Safety ...................................................................................................... 14 Part 3: ietary Exposure ............................................................................................................................. 14 Part 4: Self-Limiting Levels of Use ............................................................................................................... 15 Part 5: Experience Based on Common Use in Food .................................................................................... 15 Part 6: Narrative .......................................................................................................................................... 16 6.1 L. curvatus is part of the endogenous flora of cooked meat and poultry ............................................ 16 2 GRAS etermination for Lactobac llus curvatus SM 18775 6.2 Recognition of Safety by an Authoritative Group of Qualified Experts ................................................ 17 6.3 L. curvatus SM 18775 is non-pathogenic and non-toxigenic.............................................................. 18 6.3.1 L. curvatus SM 18775 does not produce biogenic amines ..................................................... 18 6.3.2 L. curvatus SM 18775 is susceptible to all antimicrobial agents tested .................................. 19 6.5 Conclusion of GRAS Status .................................................................................................................... 19 Part 7: List of Supporting ata and Information ......................................................................................... 20 Works Cited ................................................................................................................................................. 20 LIST OF TABLES AND FIGURES FIGURE 1 GENETIC STABILITY URING STORAGE AN PRO UCTION .........................................................................12 FIGURE 2: SIMULTANEOUS EVOLUTION OF OBSERVE AN SIMULATE CONCENTRATIONS IN LOG CFU/G OF LAB (BLUE) AN L. MONOCYTOGENES (RE ) IN COOKE HAM SAMPLES WITHOUT PROTECTIVE FLORA (LEFT) AN WITH A ITION OF L. CURVATUS SM 18775 (RIGHT) STORE AT 7°C FOR 35 AYS.......................................14 TABLE 1: ABILITY OF L. CURVATUS SM 18775 TO USE SUGARS AS A CARBON SOURCE (API50 CHL METHO ) (CHR. HANSEN) ...............................................................................................................................................................8 TABLE 2: MICROBIOLOGICAL CRITERIA AN FREQUENCY OF ANALYSES OF FREEZE- RIE AN FROZEN MEAT CULTURES............................................................................................................................................................11 TABLE 3: CRITERIA REGAR ING THE PRESENCE OF CHEMICAL CONTAMINANTS IN FREEZE- RIE MEAT CULTURES ............................................................................................................................................................................11 LIST OF APPENDICES APPEN IX 1: SM 18775 I ENTIFICATION CERTIFICATE APPEN IX 2: L. CURVATUS SM18775 PASSPORT APPEN IX 3: SM18775 BIOGENIC AMINE STATEMENT APPEN IX 4: SM18775 ANTIBIOTIC SUSCEPTIBILITY STATEMENT APPEN IX 5: PRO UCT INFORMATION SHEET 690607 APPEN IX 6: FSSC 22000 CERTIFICATE: POHLHEIM APPEN IX 7: ISO 22000 CERTIFICATE: POHLHEIM APPEN IX 8: FSSC 22000 CERTIFICATE: MILWAUKEE APPEN IX 9: HACCP FLOW SHEET GLOBAL - MEAT CULTURES APPEN IX 10: PRO UCT SPECIFICATION SHEET 690607 APPEN IX 11: PRO UCT SPECIFICATION SHEET 713185 APPEN IX 12: LIST OF ANALYSIS – MEAT CULTURES APPEN IX 13: GENERAL HAN LING OF FREEZE- RIE CULTURES APPEN IX 14: PRO UCT INFORMATION SHEET 713185 APPEN IX 15: IFIP CHALLENGE STU Y – EMULSIFIE SAUSAGE APPEN IX 16: IFIP CHALLENGE STU Y – COOKE HAM APPEN IX 17: IFIP CHALLENGE STU Y – COOKE CHICKEN APPEN IX 18: PATENT SPECIFICATION APPEN IX 19: SAFETY ATA SHEET 3 GRAS etermination for Lactobac llus curvatus SM 18775 ABBREVIATIONS EFFCA: European Food and Feed Cultures Association EFSA: European Food Safety Authority F
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