Chemistry Reference
In-Depth Information
lowerbodymass.Twostudieshavebeenconducted,oneinSwedenandtheotherinFrance,using
themaximumpermittedvaluesforASPinfood.
TheSwedishstudy(Ilbäcketal.2000)carriedoutasimulationofextremeconsumptionbytak-
ingtheconsumptionofthe10subjectswhowerethebiggestconsumersofsweeteners(outof320
subjectswhotookpartinthesurvey).Themeanweightwas20kg,andtheestimatedconsumption
ofASPwas46mg/kgbw/dor114%oftheADI.Thesedatashouldbeusedwithcareasthemaxi-
mum values concerned only 10 individuals, and the ASP contents used are the maximum levels
permittedinfood.Moreover,thedietarysurveymethodused(frequencyquestionnaire)isimprecise
andwasnotvalidated.
The French study (Garnier-Sagne, Leblanc, and Verger 2001), was conducted on a popula-
tionof227youngdiabetics(112girlsand115boys),membersoftheassociation
Aide aux Jeunes
Diabétiques
(YoungDiabeticsSupport),distributedover65outofthe95Frenchdepartmentsand
aged2to20years.Themethodusedwasthe5-daydiary.Morethan84%ofthediabeticchildren
consumedsweeteners.ThemeanconsumptionofASPwasestimatedat1.9mg/kgbw/d(lessthan
5%oftheADI),andthemaximumintakewas15.6mg/kgbw/d(40%oftheADI).Theresultswere
identicalforboysandgirls.Thisstudyalsoindicatedthatsugar-freedrinksandtabletopsweeteners
weretheformsinwhichASPwasthemostcommonlyconsumed,contributingto56%and16%,
respectively,oftheestimatedconsumption.
DuringJune2009,theU.K.-basedFSAannouncedanewstudytoexaminetheeffectsofASP
becauseofreportedsymptomsofheadachesandupsetstomachsafterconsumptionofASP.
Recentdevelopmentsincludeamethodforstabilityimprovementinaqueoussolutionsbythe
addition of a lavonoid, chlorogenic acid, or polymerized polyphenols to enhance the stability in
acidicbeverages.
Finally,theincorporationofsodiumbicarbonateintosugar-freechewinggumsalongwithASP
isarecentinnovation.Sodiumbicarbonateprovidestoothwhitening.
10.8 NeOtaMe aND SteVIa
Neotame has recently been approved by Commission Directive 2009/163 of the European
CommissionandassignedanewEnumber,E961.Theacceptabledailyintakeis0-2mg/kgbody
weight.
FollowingarequestfromtheEuropeanCommission,theAFCwasaskedtodeliverascientiic
opiniononthesafetyofneotameasasweetenerandlavorenhancer(EFSA2007).
Neotameisadipeptidemethylesterderivate.ItschemicalstructureisN-[N-(3,3-dimethylbutyl)-
L-α-aspartyl]-L-phenylalanine1-methylester.Itisintendedforuseinfoodasasweetenerandlavor
enhancer.Neotamehasasweetnessfactorapproximately7000-13,000timesgreaterthanthatof
sucroseandapproximately30-60timesgreaterthanthatofASP,dependingonthefoodapplication.
NeotameismanufacturedbythereactionofASPand3,3-dimethylbutyraldehyde,followedby
puriication,drying,andmilling.Neotameisgenerallystableunderconditionsofintendeduseasa
sweeteneracrossawiderangeoffoodandbeverageapplications.Neotamedegradesslowlyinaque-
ousconditions,suchasthoseincarbonatedsoftdrinks.
Studies with radiolabeled neotame given orally to rats indicate no accumulation in tissues.
Thehighestradioactivityisassociatedwiththecontentsofthegastrointestinaltractandorgansof
metabolismandexcretion(liver,kidney,andurinarybladder).Inwholebodyautoradiographystud-
ieswithpregnantrats,noradioactivityhasbeenreportedinthefetus.
Thesafetyofneotamehasbeeninvestigatedin
in vitro
studiesandinshort-andlong-termstud-
iesinmice,rats,rabbits,anddogs.Theresultsindicatethatneotameisnotgenotoxic,carcinogenic,
teratogenic,orassociatedwithanyreproductive/developmentaltoxicity.Theconsistentindingsin
animalstudieswerereducedfeedconsumption,bodyweight,andbodyweightgainrelativetothat
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