CXS 192-1995 食品添加剂通用法典标准（2019版）

GENERALSTANDARDFORFOODADDITIVESCODEXSTAN192-1995Adoptedin1995.Revision1997,1999,2001,2003,2004,2005,2006,2007,2008,2009,2010,2011,2012,2013,2014,2015,2016,2017,2018,2019CODEXSTAN192-19952PREAMBLE1.SCOPE1.1FoodAdditivesIncludedinthisStandardOnlythefoodadditiveslistedhereinarerecognizedassuitableforuseinfoodsinconformancewiththeprovisionsofthisStandard.1OnlyfoodadditivesthathavebeenassignedanAcceptableDailyIntake(ADI)ordetermined,onthebasisofothercriteria,tobesafe2bytheJointFAO/WHOExpertCommitteeonFoodAdditives(JECFA)3andanInternationalNumberingSystem(INS)designationbyCodexwillbeconsideredforinclusioninthisStandard.TheuseofadditivesinconformancewiththisStandardisconsideredtobetechnologicallyjustified.1.2FoodsinWhichAdditivesMayBeUsedThisStandardsetsforththeconditionsunderwhichfoodadditivesmaybeusedinallfoods,whetherornottheyhavepreviouslybeenstandardizedbyCodex.TheuseofadditivesinfoodsstandardizedbyCodexissubjecttotheconditionsofuseestablishedbytheCodexcommoditystandardsandthisStandard.TheGeneralStandardforFoodAdditives(GSFA)shouldbethesingleauthoritativereferencepointforfoodadditives.Codexcommoditycommitteeshavetheresponsibilityandexpertisetoappraiseandjustifythetechnologicalneedfortheuseofadditivesinfoodssubjecttoacommoditystandard.TheinformationgivenbythecommoditycommitteesmayalsobetakenintoaccountbytheCodexCommitteeonFoodAdditives(CCFA)whenconsideringfoodadditiveprovisionsinsimilarnon-standardizedfoods.Whenafoodisnotcoveredbyacommoditycommittee,CCFAwillappraisethetechnologicalneed.1.3FoodsinWhichAdditivesMayNotBeUsedFoodcategoriesorindividualfooditemsinwhichtheuseoffoodadditivesisnotacceptable,orwhereuseshouldberestricted,aredefinedbythisStandard.1.4MaximumUseLevelsforFoodAdditivesTheprimaryobjectiveofestablishingmaximumuselevelsforfoodadditivesinvariousfoodgroupsistoensurethattheintakeofanadditivefromallitsusesdoesnotexceeditsADI.ThefoodadditivescoveredbythisStandardandtheirmaximumuselevelsarebasedinpartonthefoodadditiveprovisionsofpreviouslyestablishedCodexcommoditystandards,orupontherequestofgovernmentsaftersubjectingtherequestedmaximumuselevelstoanappropriatemethodforverifyingthecompatibilityofaproposedmaximumlevelwiththeADI.AnnexAofthisStandardmaybeusedasafirststepinthisregard.Theevaluationofactualfoodconsumptiondataisalsoencouraged.2.DEFINITIONSa)Foodadditivemeansanysubstancenotnormallyconsumedasafoodbyitselfandnotnormallyusedasatypicalingredientofthefood,whetherornotithasnutritivevalue,theintentionaladditionofwhichtofoodforatechnological(includingorganoleptic)purposeinthemanufacture,processing,preparation,treatment,packing,packaging,transportorholdingofsuchfoodresults,ormaybereasonablyexpectedtoresult(directlyorindirectly),initoritsby-productsbecomingacomponentoforotherwiseaffectingthecharacteristicsofsuchfoods.Thetermdoesnotincludecontaminantsorsubstancesaddedtofoodformaintainingorimprovingnutritionalqualities.41NotwithstandingtheprovisionsofthisSectionoftheGeneralStandard,thelackofreferencetoaparticularadditiveortoaparticularuseofanadditiveinafoodintheGeneralStandardascurrentlydrafted,doesnotimplythattheadditiveisunsafeorunsuitableforuseinfood.TheCommissionshallreviewthenecessityformaintainingthisfootnoteonaregularbasis,withaviewtoitsdeletiononcetheGeneralStandardissubstantiallycomplete.2Forthepurposeofthisstandard“determined,onthebasisofothercriteria,tobesafe”meansthattheuseofafoodadditivedoesnotposeasafetyconcernunderconditionsofusedescribedbyJECFAasbeingofnotoxicologicalconcern(e.g.uselevelsdefinedcircumstances).3AdatabaseoffoodadditivespecificationswiththeircurrentADIstatus,theyearoftheirmostrecentJECFAevaluation,theirassignedINSnumbers,etc.areavailableinEnglishattheJECFAwebsiteatFAO://apps.who.int/food-additives-contaminants-jecfa-database/search.aspx4CodexAlimentariusProceduralManual.CODEXSTAN192-19953b)AcceptableDailyIntake(ADI)isanestimatebyJECFAoftheamountofafoodadditive,expressedonabodyweightbasisthatcanbeingesteddailyoveralifetimewithoutappreciablehealthrisk.5c)AcceptableDailyIntakeNotSpecified(NS)6isatermapplicabletoafoodsubstanceofverylowtoxicityforwhich,onthebasisoftheavailabledata(chemical,biochemical,toxicological,andother),thetotaldietaryintakeofthesubstance,arisingfromitsuseatthelevelsnecessarytoachievethedesiredeffectandfromitsacceptablebackgroundlevelsinfood,doesnot,intheopinionofJECFA,representahazardtohealth.Fortheabovereason,andforreasonsstatedinindividualJECFAevaluations,establishmentofanacceptabledailyintakeexpressedinnumericalformisnotdeemednecessarybyJECFA.Anadditivemeetingtheabovecriterionmustbeusedwithintheboundsofgoodmanufacturingpracticeasdefinedinsection3.3below.d)MaximumUseLevelofanadditiveisthehighestconcentrationoftheadditivedeterminedtobefunctionallyeffectiveinafoodorfoodcategoryandagreedtobesafebytheCodexAlimentariusCommission.Itis