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GRAS Notice 845 for Lactobacillus Rhamnosus

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GRAS Notice 845 for Lactobacillus Rhamnosus GRAS Notice (GRN) No. 845 https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory CHR.._HANSEN FEB 1 3 2019 OFFICE OF FOOD ADDITI\11: SAFETY January 31, 2019 Chr. Hansen, Inc. 9015 West Maple Street Milwaukee, WI 53214 - 4298 www.chr-hansen.com [email protected] 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 Office of Food Additive Safety: In accordance with the guidance issued by the Food and Drug Ad­ ministration (FDA) under 21 81 Fed. Reg. 54960 (Aug. 17, 2016), Chr. Hansen hereby provides notice of a claim that the use of Lac­ tobacillus rhamnosus LGG® in conventional foods as described in the enclosed notification is Generally Recognized As Safe (GRAS) based on scientific procedures. The enclosed triplicate copies of the submission each include form FDA 3667, a comprehensive GRAS assessment, and appendix doc­ uments in support of the assessment, for your consideration. Please feel free to contact me directly to discuss any aspects of this submission. Sincerely, (b) (6) Sarah F. Kraak-Ripple Regulatory Affairs Manager Human Health - North America Chr. Hansen, Inc. Fann Approved: 0MB No_0910-0342; Expuclllan Dill!: 09/J0t2D19 see est tbl OUB stateme11 FDA USE ONLY DEPARTMENT OF HEALTH Al«l HUMAN SERVICES Food and Drug Administration GENERALLY RECOGNIZED AS SAFE NflME FOR INTERNET {GRAS} NOTICE (Subpart E of Part 170) Tr.ansnit completed form and attachments eledr011ic .. lly via the Bectn:ric Submis5ion Gateway (aee ~ OR Transmit coq,leted form and attadlments in paper format or on physical mecia n Office of Food Adcitive Satety (HFS-200). Center fm" Food Safety and Applied Nutrition. Food and Drug Administralion.5001 Cempus Drive, College Park. MD 20740-3835_ SECTION A - INTRODUCTORY INFORMATION ABOUT THE SUBMISSION f . Type of Submission (Check aneJ 181 New O Amenmnent to GRN No_ 0 Supplement to GRN No. 2. D All electronic fies included .-. this subrmsion have been ched;ed and fumd to be virus free_( Checft box to verify) 3 .:: =- or !.,men 1 :-ds or Supc <: ens: I·; your S:h1::i-, ,nel amendment or suppement submibed in D Yes If yes, enter 1he dale of response lo a communication from FDA? D No communic.tion (yyyylmmldd): ______ SECTION B - INFORMATION ABOUT THE NOTIFIER Name or~ Per.ion Posiion « TIiie ~anti F. KraK-Rippk! I ~uhrtory Affairs Manager I Organization (if appficable) f ,1.. Notifier p,,. Hansen, Inc. Mailing Address (numbet" and street) ~15 WHt Maple Stn!et I c~ State or Province Zip Code/Postal Code Country ~ilwau4iee I IWilctlnan [3 5'1214 Enited Stah!s d America [3 T ejephone Number Fax Numb« E-Mail Address ~14-614-9348 I 41~7-5959 uuakrGrJct-r-hansen.com Name of Contact Per.;on Position or Title tb. Ageat arAttamey Organiution (if applicableJ (if~e} Ma-.g Address (numlJ« and weet} City state Cl" Prow1ce .Z.., Code/Postal Code Counlry B Telephone Number Fax Number E-1,hiill Address FORM FDA 36167 fl1117) Page 1 of-4 SECTION C - GENERAL ADMINISTRA TI\/E INFORMATION 2. Smmission Format (Check appropriate box(es)) 3. ~or paper SU1>mIssrons onry: 0 Elec:Rnic Submission Giideway 0 Electronic files on phJ§ical media Nurmer of vounes 3 ~ P;;iper If appic.able give number iind type of physical med~ Total nu!Ti>er of pages 4. Does this Sd>mission nccxporate any infcrmalion in CFSAN's ties? {Chedc one} 0 Yes (PToceed fD Item 5) ~ No (Pmceed a, /fem 6} 5. The umissioo ~ monnallon from a previous submisgon to FDA as indicated below (Chect al that apply} 0 a) GRAS Notice No. GRN 0 b) GRAS Affinnation Petition No. GRP 0 c) Food Additive Petition No. F P.P 0 d) Food Master File No. FMF D e) ~ or Additional (de:H!dle oren,e,- i-ibmaeion a3 illxwe) _____________________ 6. S1allltay basis tc,- condusitJns of GRAS st.tus (Chedc one} ~ Scierdc procedures (21 CFR 170.30(a) and (b}J D Experience based on commm use in food (21 CFR 170.30(a} ~ (c)} 7. Does 1IR !ilbnissul flldlding inform.lion lhat you are incorpof"alqJ) contain nfmmiltDt that you view as lliillde secfl!t or as oonfidenlial CD111men:&I or inancial inform~? (see 21 CFR 170..225(c)(8)) 0 Yes (Proceed fD Item fl BIND tp,:rx:eedbSedilRDJ 8. Hawe you design~ infDrmiiltion wi your submission that you view as trade secret or as conlidentiilll commerci~ or tinancfili informalion (Chedc all t#Jat apply) 0 Yes, information is designilll!d at the place where - occurs in the sullmission No 9. Have you attached ii redacted copy of some or all of 1he submission? (Check one) D Yes. a redacted copy of the complete smmission D Yes. a n!dacled copy of pa,t(s) of lie submission No SECTION D - INTENDED USE 1. Desaile the inh!nded conditions of use of the notified substance, including the foods in which the substance wil be used, lie le111els of use in such foods. ind 1he purposes fDr •hict'I the substance will be used, indudin9, when appropri.ite. a descriptiDn of a soopopgaiion expected ID consume 1he notified substance. nCJ5U5 LGG ls inte ' to us as an ingff! lent in mnventlona at e s consistent wl curTent goo · man ng 0!5. It is kltended to be conswned by the generat populiltlon. Intended applications included but are not llmlbd to; milk and airy products such as yogurt and other fermented mlN< producb; dawy alternatives (plant-based (oat, soy, almond, coconut,, pa, . J fermented m•k and yogurt productst beverages such as juke and proU!in shakes; shelf-stable products such as ban (gfill'!Oa, n, meal •iKl!fflel'lt bars~ confectionery (gunmy candy, hard candy, 510ft chew candy, chewing guff\ coati,gs); brmlcfast • The Intended level of use Is between 1o' to 1o,o cfu/seNi with an lnltla1 toad of to 1011 du/servi 2. Does lie intended use of 1he notified substance include iilllY use mpoduct(s) ~ 1o regut.dion by the Food SaJety and lnspeclioo Service (FSIS) of the U.S. Department of Agriculure? (Checkane} Yes ~No 3. If your Sd>mission ~ trade seaets. do you authorize FDA tc pn,vide 1his information ID 1he Food Safety and lnspeclion Service of the U.S. Department of Agricullure? (Checll oneJ jg] Yes O No • you ask us 1D exclude nde secnts from the infonnation FDA wil send ID FSIS. FORM FDA 3667 fl1111) Page2af4 SECTION E - PARTS 2 -7 OF YOUR GRAS NOTICE ___ _._chec~ lis t to he ,p ;;. n.: ure y c ur 3ubm133ion ,'s ;;:Jmo,'ete - PART 1 is ad_d!~::;_:;;eo in other sections of rh1s fotm 1 __ lgj PART 2 of a GRAS natic:e: Identity, method of marufacture, specificaiions. and physical or lechnical effect (17D.230). ~ PART 3 of a GRAS notice: Dieay exposure (170.235). ~ PART 4 of a GRAS notice: Setf-limimg levels of use (170.240). lgj PART 5 of a GRAS notice: Experience based on commoo use in foods before 1958 (170.245). ~ PART 6 of a GRAS notice: Narratiwe (170.250). lgj PART 7 of a GRAS nalic:e: List of su~ d.la and informa1ion in your GRAS notice (17D.255) , other lnfonnation I Did you irdlde any ottN!I" intormaticn 1hat you want FDA ID consider in e¥aluating you- GRAS notice? 181 Yes D No Did you irdlde this alher information in the lis1 of aHadlments? 181 Yes Na - - SECTION F - SIGNATURE AND CERTIFICATION STATEMENTS --- 1. 1he under.;igned is inlDnnng FDA flat Sarah F. Kraak~ El has concluded that the intended use(~} of Lactobildllus rfwnnasus LGG• descri>ed on this form. as discussed in the atlactled oolice. is (are) not subject to the premiilltet approval requirements of fie Federal FDCJd, Drug. iilnd Cosmetic Act based m Y(Ma- conctusion that the substance is generally recognized as safe recognized as safe under the conditions of its intended use in acoordalce nh § 17D.30. 2. Sarah F. Knak-flpple .iwees to make the dilta iillld monnation that are fie basis for the "1etlle atflOllfftf'J conclusion of GRAS s&aus a~le to FDA if FDA asks ID see them; agrees to alDw FDA to review and copv these data iillld intormaticn dumg customary business hows at the fclDwing location if FDA asks to do so; .il!IJn!eS to send these data and inlonnation ID FDA if FDA asks to do so. 9015 West Maple street, Mitwaukee_ WI 53214 (ollllilllrss al~o, ~ bcalbn, The notifying party certifies that this GRAS oolice is a complete. 1epresentalille. and baalCed sullmission flat irdldes unfavorable, as lllel as favorable information. perinentto fie e¥aluation of the safety iilnd GRAS stws of the use of the subslance.The notifying party certifies that lhe infDnniUln prowled herein is accurate and complele to fie best or his/her knowledge. hr/ knowing and willful misnll!rpretalion is subject to criminiillll penalty pursuant to 18 U.S.C. 1 001. Prinll!d Na111e t1nd Tdle (b) (6) FORM FDA 3667 fl1111) Page 3 of4 SECTION G - LIST OF ATTACHMENTS List your atliillched files or documents canlaining p.-submissian. fmns,, amendmenJs or supplernenls, and other perment infoonalion. Cleaty identify the alladlment with appropri;a descriptive file names (or titles tar- paper docmnents). preferably as suggested in lhe guidiilllllCe ilSSOciated with llis foon. Nlanber- ytU' abadlments conseculivety. When smmitmg paper documents. enter lie inclusive page numbers of each partion of the document below.
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