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regularfoods,specialfoods,andallfoods(regularandspecialfoods)andshouldconcernthewhole
population,segmentsofthepopulation,andindividuals.
14.5.4 risk Characterization
Riskcharacterizationisthestepofriskassessmentthatintegratesinformationfromexposure
assessment and hazard characterization into advice suitable for risk management. Based on the
actual exposure assessment, this step determines which fraction, if any, of the population would
haveintakeshigherthantheADIandestimatesthemagnitudebywhichtheexposureswouldexceed
theADI.Thehealthimpact,ifany,ofthisexcessisevaluatedinagivenpopulationaswellasthe
seriousnessofanyhealthrisk.Theconclusionsofriskassessorscanbethattheexpectedexposure
issafeaccordingtotheestablishedADIorthatitwillleadtoexceedingoftheADI.
AnoccasionalexceedingoftheADI,althoughundesirablefromatoxicologicalpointofview,
doesnotposeanimmediatehealthrisk(Barlowetal.1999;LarsenandRichold1999).Asaper-
manent exceeding of the ADI is associated with an appreciable health risk and, therefore, is not
acceptable,reductionsinexposureareneededtocomplywiththeADI.Itisuptoriskmanagersto
establishprovisionsneededtoensurethecomplianceofexposuretotheADI.Furthermore,itmust
becontrolledtoensurethattheimplementedprovisionshavethedesiredeffect.IntheEU,therisk
managementofsweetenerslikeotherfoodadditivesiswithintheEUCommission.
14.6 eU reGULatIONS OF the USe OF SWeeteNerS IN FOOD prODUCtS
TheuseofsweetenersintheEUhasbeenregulatedbyaframeworkdirective(CouncilDirective
89/107/EECof21December1988ontheapproximationofthelawsoftheMemberStatesconcern-
ingfoodadditivesauthorizedforuseinfoodstuffsintendedforhumanconsumption,asamendedby
Directive94/34/EC)andaspeciicdirective,EuropeanParliamentandCouncilDirective94/35/EC
ofJune1994onsweetenersforuseinfoodstuffs,amendedbyDirectives96/83/ECand2003/115/
EC.Theannexestothespeciicdirectivesprovidedtheinformationonwhichsweetenerswereper-
mittedindifferentfoodstuffsorgroupsoffoodstuffstogetherwiththemaximumpermittedlevels.
Thespeciicdirectiveshaveprovisionsfortheperiodicmonitoringoftheuseoffoodadditives.
TheEUmonitoringsystemisbasedonrecommendationsgiveninthereportoftheWorkingGroup
ontheDevelopmentofMethodsforMonitoringIntakeofFoodAdditivesintheEU,Task4.2ofthe
ScientiicCooperationonQuestionsRelatingtoFood(publishedontheCommissionwebsite,
http://
The regulation of food additives is now governed by Regulation (EC) No. 1333/2008 of 16
December 2008 on food additives. The authorization of a new food additive shall now follow
Regulation(EC)No.1331/2008of16December2008establishingacommonauthorizationproce-
dureforfoodadditives,foodenzymes,andfoodlavorings.
ThereviewofpublisheddataontheintakeofintensesweetenersintheEUupto1997indicated
thattheiraverageintakeswerebelowtherelevantADIvalues.Theintakesbythehighestconsumers
ofsweetenersotherthancyclamatewerealsobelowtheirADIs.Thehighestestimatedintakesof
cyclamatebydiabeticsandchildrenwereclosetoorslightlyabovetheADI(Renwick1999).
StudiesontheintakeofintensesweetenersindifferentcountriesoftheEUpublishedsince1999
indicatethattheaverageand95thpercentileintakesofacesulfameK,aspartame,cyclamate,and
saccharinbyadultsarebelowtherelevantADIs(Renwick2006;Lethetal.2008).
Bulksweeteners(polyols)permittedintheEUarenotincludedintheEUmonitoringsystem.
Monitoringoftheexposuretobulksweetenersisnotfeasible,asnoupperlimitsfortheirusehas
beenspeciied.Theyarealsoauthorizedforpurposesotherthansweeteninginallfoodswhere
additivesmaybeused,exceptforbeveragesotherthanliqueurs.
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