EU, U.S., and Third World Country Regulations and Japanese Legislation - Sweeteners: Nutritional Aspects, Applications, and Production Technology - page 316

theabsorptionofthelatterwouldbe85%.ThiswouldbemoreappropriateforcalculatinganADI.
Becauseamaximumconversionigurewouldbeutilized,areducedsafetyfactorshouldbeapplied
forinterindividualdifferences.
ThecommitteeconcludedthatafullADIforCYCcouldnowbeestablished.TakingaNOAEL
of 100 mg/kg bw for cyclohexylamine, allowing for the difference in molecular weight between
cyclamicacidandcyclohexylamine,usingan85%overallconversionrateforingestedCYC,and
applyinga32-foldsafetyfactor,afullADIof0-7mg/kgbw,expressedascyclamicacid,forcycla-
micacidanditssodiumandcalciumsaltswasestablishedbythecommittee.
TheADIforCYChasbeensetat11mg/kgbwbytheJECFAandat7mg/kgbwbytheSCF.
Witharelativesweetnessofapproximately40andtherecommendedADIbytheSCF,thesugar
equivalentis280.
Arcellaetal.(2004)designedafoodfrequencyquestionnairetoidentifyadolescentswhowere
highconsumersofsugar-freesoftdrinksandtabletopsweeteners.Arandomlyextractedsampleof
teenagers( n =3982)livingintheDistrictofRome(Italy)illeditin.Aconsumersurveywasthen
carriedoutinarandomlyextractedsubsampleofmalesandfemalesandinallfemaleswhoreported
ahighconsumptionofsugar-freesoftdrinksand/ortabletopsweeteners.Atotalof362subjectspar-
ticipatedinadetailedfoodsurveybyrecording,atthebrandlevel,allfoodsandbeveragesingested
over12days.Foreachsugar-freeproduct,producersprovidedtheconcentrationofintensesweeten-
ers(SAC,ASP,ACSK,andCYC).
No intake in excess of the ADI was observed. In addition, medicines and supplements were
takenintoaccount,andthesedidnotresultinalargeimpactonchronicexposuretointensesweet-
eners. The intake levels did not exceed the ADI even under a worst-case scenario, which was
performedtotakeintoaccountahypotheticalfuturesubstitutionofallregularfoodproductswith
theirsugar-freeversion.Itcanbeconcludedthat,withtheobservedcurrentconsumptionpatterns
andoccurrencelevels,theriskofanexcessiveintakeofintensesweetenersbyItalianteenagersis
extremelylow.
Ajinomoto used it as an effective agent (agonist) for appetite regulation and gastrointestinal
healthpromotion,alleviatinggastroesophagealreluxdiseaseandfunctionaldyspepsia.
10.10 SUCraLOSe aND aCeSULFaMe K
BothofthesesweetenerswereapprovedbyDirective2003/115.ForSCL,wehaveanopinion
oftheSCFonSCLsince2000(SCF2000),followingtheallocationofanADIasasweetenerina
largenumberofcountries.
TheADIforACSKhasbeensetat15mg/kgbwbytheJECFAandat9mg/kgbwbytheSCF.
Witharelativesweetnessofapproximately200andwiththerecommendedADIofSCF,thesugar
equivalentis1800.
Thereisadequateevidence,bothforSCLanditshydrolysisproducts,thattherearenoconcerns
aboutmutagenicity,carcinogenicity,anddevelopmentalorreproductivetoxicity.Effectshavebeen
observed in some experimental animal studies on immune parameters, the gastrointestinal tract,
andbodyweightgain.Considerationofthecriticalstudiesontheseaspectshaveidentiiedreduced
bodyweightgain,whenitisattributabletodirectSCLtoxicityratherthansecondarilytoreduced
foodintakebecauseofimpalatabilityofthediet,asthepivotaleffectforestablishinganADI.The
overallNOAELforsuchreductionsinbodyweightgainwas1500mg/kgbw/day.
ThecommitteeconcludesthatSCLisacceptableasasweetenerforgeneralfooduseandthata
fullADIof0-15mg/kgbwcanbeestablishedbasedontheapplicationofa100-foldsafetyfactorto
theoverallNOAELof1500mg/kgbw/day.
TherelativesweetnessofSCLis600;hence,thesugarequivalentis600×15=9000.