Safety of a botanical extract derived from Panax notoginseng ...

Safety of a botanical extract derived from Panax notoginseng and Astragalus membranaceus (AstraGin™) as a novel food pursuant to Regulation (EU) ... SkiptomaincontentOthersitesEFSAOpenEFSAEFSAJournalConnectAboutHowweworkValuesTransparencyWorkingpracticesTrustedscienceExternalexpertsGovernanceManagementBoardmembersExecutiveDirectorOperationalManagementPartnersEUMemberStatesEUinstitutionsandagenciesCompetentorganisationsinMemberStatesInternationalStakeholderengagementDocumentsCorporatepublicationsNewsroomNewsDatavisualizationCampaignsInfographicsVideosFactsheetsTopicsFulllistAnimalhealthAntimicrobialresistanceBeehealthNutritionPesticidesPesticidesandbees:guidancereviewPlanthealthXylellafastidiosaGlossaryResourcesDatareportsDatastandardisationFoodtracingDatacollectionMethodologyGuidanceEvidenceToolsandresourcesDietaryExposure(DietEx)toolPublicationsApplicationsOverviewBiologicalhazardsFeedadditivesFoodcontactmaterialsFoodimprovementagentsGMONovelfoodNutritionPesticidesServicesforapplicantsToolkitTrackyourapplicationEventcalendarAskaquestionEngageCareersStaffExpertsSecondmentsYoungprofessionalsSelectionprocessFellowshipProgrammeProcurementUpcomingTenders€140k+Tenders€140k+Tenders€15k-€140kScientificandtechnicalsupportToolboxGrantsCallsfordataConsultationsObserversResearchPlatformStakeholdersEngagementplatformsEngagementinriskassessmentCallsforstakeholdersStakeholderregistrationCalendarSafetyofabotanicalextractderivedfromPanaxnotoginsengandAstragalusmembranaceus(AstraGin™)asanovelfoodpursuanttoRegulation(EU)2015/2283Published:13May2020Adopted:24March2020ontheWileyOnlineLibraryFullarticle:HTMLPDFMetadataEFSAJournal2020;18(5):6099DOI:https://doi.org/10.2903/j.efsa.2020.6099Keywords:Panaxnotoginseng,Astragalusmembranaceus,Astragaluspropinquus,extract,novelfood,safetyOnrequestfrom:EuropeanCommissionfollowinganapplicationbyNuLivScienceQuestionNumber:EFSA‐Q‐2018‐00557Contact:nda[at]efsa.europa.euPanelmembersatthetimeofadoptionDominiqueTurck,JacquelineCastenmiller,StefaanDeHenauw,KarenIldicoHirsch‐Ernst,JohnKearney,HelleKatrineKnutsen,AlexandreMaciuk,IngeMangelsdorf,HarryJMcArdle,AndronikiNaska,CarmenPelaez,KristinaPentieva,AlfonsoSiani,FrankThies,SophiaTsabouriandMarcoVinceti.AbstractFollowingarequestfromtheEuropeanCommission,theEFSAPanelonNutrition,NovelFoodsandFoodAllergens(NDA)wasaskedtodeliverascientificopiniononabotanicalextractderivedfrombothPanaxnotoginsengandAstragalusmembranaceus(AstraGin™)asanovelfood(NF)pursuanttoRegulation(EU)2015/2283.TheNFisacombinationofanethanolextractoftherootsofA.membranaceusandahotwaterextractoftherootsofP.notoginseng.TheNFcontains1.5–5%totalsaponins,0.1–0.5%ginsenosideRb1and0.01–0.1%astragalosideI.BothplantsthatareusedtoproducetheNFhavealonghistoryofuse,especiallyintraditionalChinesemedicine.InformationontheproductionprocessandthecompositionoftheNFissufficientanddoesnotraisesafetyconcerns.TheapplicantproposedtousetheNFasafoodsupplementforthegeneraladultpopulation,excludingpregnantwomen,atamaximumdailyamountof350mg.Takingintoaccounttheseconditionsofuse,thePanelconsidersthattheconsumptionoftheNFisnotnutritionallydisadvantageous.TheprovidedgenotoxicitystudiesdonotraiseconcernsforgenotoxicityoftheNF.Basedonthefindingsofasubchronictoxicitystudy,supportedbyasubacutetoxicitystudy,thePanelidentifiedtheoverallnoobservedadverseeffectlevel(NOAEL)oftheNFat100mg/kgbodyweight(bw)perday.Byapplyinganuncertaintyfactorof200,thePanelconcludesthattheNFissafeatanintakelevelof0.5mg/kgbwperday,correspondingtoamaximumdailyintakeof35mgoftheNFforthetargetpopulation,i.e.adultsexcludingpregnantwomen.©EuropeanFoodSafetyAuthorityRelatedtopic(s)Foodsupplements