Chemistry Reference
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ofcontrolswithnocleardoseresponse.Theseeffectsareconsiderednotadverseorindicativeof
toxicity,butaconsequenceofreducedpalatabilityoftheneotame-containingdiets.Therefore,body
weightparameterswerenotconsideredappropriateendpointsforsettingNOAELsinthesestudies.
Theresultsofhumanstudiesdemonstratedthatneotamewaswelltoleratedbyhealthyanddia-
betichumansubjectsatdoselevelsupto1.5mg/kgbw/day(thehighestdosetested).Theexposure
tomethanol,whichmayresultfromtheingestionofneotame-containingfoodsandbeverages,is
considerednegligiblecomparedtothatfromotherdietarysourcesand,assuch,ofnoconcernfrom
thesafetypointofview.
Thepanelnotedthattheadditionalphenylalanineintakeexpectedfromtheingestionofneo-
tame as a general-purpose sweetener represents a relatively small increment in the exposure to
phenylalanineofthephenylketonurichomozygouschild.
Afterconsideringallthedataonstability,degradationproducts,andtoxicology,thepanelcon-
cludedthatneotameisnotofsafetyconcernwithrespecttotheproposedusesasasweetenerand
lavorenhancer.
ThepanelestablishedanADIof0-2mg/kgbw/daybasedontheapplicationofa100-foldsafety
factortotheNOAELof200mg/kgbwfroma52-weekdogstudy.
Conservativeestimatesofdietaryexposurebothinadultsandchildrensuggestitisveryunlikely
thattheADIwouldbeexceededattheproposeduselevels.
The panel recommends that the limitfor leadin the speciications shouldnot be higherthan
1 mg/kg(EFSA2007).
TheWrigleyCompanyhasdevelopedamethodforcontrollingthereleaseofneotameinchew-
ing gum. Derivatives of ASP are treated to control their release and enhance shelf-life stability.
Modiiedreleaseisobtainedbyphysicalmodiicationofsweetenerpropertiesviacoatinganddry-
ing(LeatherheadFoodResearch2010).
CadburyAdamsdescribedachewinggumcompositioncontainingneotameinitsfreestate(not
encapsulated)withprolongedsweeteningsensation.
NeotameandACSKhavebeenblendedandactsynergisticallyataratioof90:10(PepsiCo).
SteviaisanaturalsweetenerallowedforuseintheUnitedStatesandAsia,whereasinEurope,
ithasnotbeenapprovedyet.
FollowingarequestfromtheEuropeanCommission,arevisedexposureassessmentofsteviol
glycosidesfromtheiruseasafoodadditivewascarriedoutforchildrenandadultsbasedonthe
revisedproposedusespresentedinthetermsofreference.
Severalfoodconsumptiondatabaseswereusedtoconducttherevisedexposureassessment.For
children,datafromtheIndividualFoodConsumptionDataandExposureAssessmentStudiesfor
Children(EXPOCHIProject)andtheU.K.NationalDietandNutritionSurvey(NDNS)wereused.
EstimatesforadultswerebasedonU.K.dataonly(EFSA2011).
Foradults,exposureestimatesgiveameandietaryexposuretosteviolglycosides,expressedas
steviolequivalents,of1.9-2.3mg/kgbw/dayandof5.6-6.8mg/kgbw/dayforhigh-levelexposures
(97.5thpercentile),withthemaincontributorsbeingnonalcoholiclavoreddrinks,tabletopsweeten-
ers,andbeerandcider.
ForEuropeanchildren(aged1to14years),exposureestimatesgiveameandietaryexposure
tosteviolglycosides,expressedassteviolequivalents,of0.4-6.4mg/kgbw/day;atthehighlevel
(95th/97.5thpercentile),andexposureestimatesrangefrom1.7to16.3mg/kgbw/day.
Consideringthelimitationsofconsumptiondata,estimatescanbeconsideredconservativeas
intheANSpanelopinion(2010).
The EFSA comprehensive database was used to identify and assess the uncertainty resulting
fromtheconsumptiondatafromthefoodgroup“nonalcoholiclavoreddrinks,”themaincontribu-
torforbothchildrenandadults.
Fromthesedata,nogeneraltendencywasobservedregardingthedifferencebetweentheconsump-
tionlevelsoflow-calorienonalcoholiclavoreddrinks(softdrinks)andnormal-caloriesoftdrinks.
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