CACGL3-1989

GUIDELINESFORTHESIMPLEEVALUATIONOFDIETARYEXPOSURETOFOODADDITIVESCAC/GL3-1989Adopted1989.Revision2014(formerlyGuidelinesfortheSimpleEvaluationofFoodAdditiveIntake)CAC/GL3-198921.INTRODUCTIONTheGeneralStandardforFoodAdditives(GSFA)statesinitsPreamblethattheuseoffoodadditivesisjustifiedonlywhensuchusehasanadvantage,doesnotpresentanappreciablehealthrisktoconsumers,doesnotmisleadtheconsumer,andservesoneormoretechnologicalfunctions.Thequantityofafoodadditiveaddedtofoodshallbelimitedtothelowestlevelnecessarytoachievetheintendedtechnicaleffect1,accordingtothebasicprincipleoftheGoodManufacturePractice(GMP).Inregardtoprotectingthehealthoftheconsumers,principlesforriskanalysishavebeenappliedintheframeworkoftheCodexAlimentarius.RiskanalysishasbeendefinedbytheCodexAlimentariusCommission(CAC)asaprocessconsistingofthreecloselylinkedcomponents:riskassessment,riskmanagementandriskcommunication2.Riskassessmentisdefinedasascientificallybasedprocessconsistingofthefollowingsteps:1)hazardidentification,2)hazardcharacterization,3)exposureassessmentand4)riskcharacterization3.TheJointFAO/WHOExpertCommitteeonFoodAdditives(JECFA)isprimarilyresponsibleforperformingtheriskassessmentsuponwhichCodexCommitteeonFoodAdditives(CCFA)andultimatelytheCACbasetheirriskmanagementdecision4.Onaninternationallevel,thefirststepintheconsiderationofthesafetyassessmentoffoodadditivesisanevaluationbyJECFA,includingtheestablishmentofanAcceptableDailyIntake(ADI),whererelevant,andtheelaborationoftheiridentityandpuritycriteria.TheADIisanestimateoftheamountofafoodadditiveinfoodorbeveragesexpressedonabodyweight(bw)basisthatcanbeingesteddailyoveralifetimewithoutappreciablehealthrisktotheconsumer5.Itisderivedonthebasisofalltheknownfactsatthetimeoftheevaluation.TheADIisexpressedinmilligramsofthefoodadditiveperkilogramofbodyweight6onadailybasis.JECFAevaluatestheestimateddietaryexposuresand,intheriskcharacterizationstep,comparestheprobableexposuretothefoodadditivewiththerelevantADI7.Inthesecondstep,proposalsforthepermitteduseofanadditiveindifferentfoodsaremadebytheresponsiblenationalauthoritiesorbytheCodexCommodityCommitteestotheCCFA.TheendorsementoftheproposedusebytheCCFAshouldtakeintoaccounttheADI,oranequivalenthealthbasedguidancevalue,establishedfortheadditivebyJECFAandtheprobabledailydietaryexposuretotheadditivefromallfoodsources.Whenthefoodadditiveistobeusedinfoodseatenbyspecialgroupsofconsumers(e.g.,diabetics,thoseonspecialmedicaldiets,sickindividualsonformulatedliquiddiets),accountshallbetakenoftheprobabledailydietaryexposuretothefoodadditivebythoseconsumers.Therearedifferentapproachesforestimatingtheprobabledailydietaryexposuretofoodadditives.Someoftheseapproachesareveryexpensiveandtimeconsumingandmayposedifficultiestosomecountriesininitiatingsuchdietaryexposureassessmentsforfoodadditives.Therefore,thepresentguidelinesareintendedtofacilitatetheworkofgovernments,particularlyforcountrieswithlimitedresources,ontheassessmentofdietaryexposuretofoodadditivesbyreflectingcurrentproceduresinplacetocarryoutsuchworkinasimpleway.ThepresentguidelinesarenotintendedtoprovidesupporttoCCFAontheworkontheGSFA,asJECFAistheinternationalexpertscientificadvisorybodytoprovidesuchadvicetotheCommitteebasedonthePrinciplesandMethodsforTheRiskAssessmentofChemicalsinFood-EnvironmentalHealthCriteria(EHC)240.1PreambletotheGeneralStandardforFoodAdditives(GSFA;CODEXSTAN192-1995,availableat“Standards”menu).2CodexAlimentariusCommissionProceduralManual(21stEd.)SectionIV:RiskAnalysis,WorkingPrinciplesforRiskAnalysisforApplicationintheframeworkoftheCodexAlimentarius,pp.107-113.3CodexAlimentariusCommissionProceduralManual(21stEd.)SectionIV:RiskAnalysis,DefinitionsofRiskAnalysisTermsRelatedtoFoodSafety,pp.114-115.4CodexAlimentariusCommissionProceduralManual(21stEd.)SectionIV:RiskAnalysis,“RiskAnalysisPrinciplesAppliedbytheCodexCommitteeonFoodAdditives”,pp.116-120.5Forthispurpose,withoutappreciableriskistakentomeanthepracticalcertaintythatinjurywillnotresultevenafteralife-time'sexposure(PreambletotheGSFA;CODEXSTAN192-1995).6Themethodsusedtoestablishhealth-basedguidancevaluesuchasanADIaredescribedinChapter5ofthepublicationPrinciplesandMethodsfortheRiskAssessmentofChemicalsinFood-EnvironmentalHealthCriteria240(EHC240;FoodandAgricultureOrganizationoftheUnitedNationsandtheWorldHealthOrganization,2009;)Chapter5.7JECFA´smonographsareavailableat:(1)theconcentrationofthefoodadditiveinfood;(2)theamountoffoodconsumed;and(3)theaveragebodyweightofthepopulation(kg).Thegeneralequationfordietary