EU, U.S., and Third World Country Regulations and Japanese Legislation - Sweeteners: Nutritional Aspects, Applications, and Production Technology - page 314

Therefore,theconsumptionlevelsofnormal-caloriesoftdrinkswereconsideredanacceptable
approximation of the consumption levels of low-calorie soft drinks, and thus, the exposure esti-
matesforadultswerenotcorrected.
Forchildren,thedatafromEXPOCHIfortheconsumptionofnonalcoholiclavoreddrinks(soft
drinks)werefoundtobegenerallyhigherthantheconsumptionoflow-caloriesoftdrinksfromthe
EFSAcomprehensivedatabasebyafactorof2.Consequently,thedatafromtheEFSAcomprehen-
sivedatabasewereusedtocorrecttheconsumptionofthisfoodgroup.Thecorrectedexposureesti-
matesforchildrenwhoarehighconsumers(95thpercentile)rangefrom1.0to12.7mg/kgbw/day.
The revised mean exposure estimates differ only slightly from the exposure estimates given
intheANSpanelopinion(2010).ByusingtheEFSAcomprehensivedatabase,theupperrangeof
high-levelexposureestimatesdecreasedfromamaximumof17.2fromtheANSpanelopinionto
12.7mg/kgbw/dayforchildren,buthigh-consumingchildren'sexposuresarestillabovetheADIof
4mg/kgbw/dayforseveralcountries.
Theresultsofthenewstudiespresentedtothecommitteeatitspresentmeetinghaveshownno
adverseeffectsofsteviolglycosideswhentakenatdosesofabout4mg/kgbwperday,expressedas
steviol,forupto16weeksbyindividualswithtype2diabetesmellitusandindividualswithnormal
orlow-normalbloodpressurefor4weeks.Thecommitteeconcludedthatthenewdataweresuf-
icienttoallowtheadditionalsafetyfactorof2andthetemporarydesignationtoberemovedand
establishedanADIforsteviolglycosidesof0-4mg/kgbwexpressedassteviol(JECFA2009).
Thecommitteenotedthatsomeestimatesofhigh-percentiledietaryexposuretosteviolglyco-
sidesexceededtheADI,particularlywhenassumingcompletereplacementofcaloricsweeteners
with steviol glycosides, but recognized that these estimates were highly conservative and actual
intakeswerelikelytobewithintheADIrange(JECFA2009).
The committee evaluated an estimate of dietary exposure to steviol glycosides based on the
replacementofalldietarysugarsintheUnitedStates.Usingapercapitaestimateof176gofcaloric
sweetenerperday,thecommitteecalculatedthattheconsumptionofsteviolglycosideswouldbe
5.8mg/kgbwperday.Additionally,publishedestimatesofexposuretorebaudiosideA,basedon
exposuretootherhigh-intensitysweetenersandusingtheprincipleofequivalentsweetness,were
evaluatedbythecommittee.Theseestimateswere1.5mg/kgbwperdayfordiabeticchildrenand
adultsand1.7mg/kgbwperdayfornondiabeticchildrenconsumingthesweeteneratahighper-
centileoftheexposuredistribution,takentobegreaterthanthe90thpercentile.ForJapan,theper
capitareplacementestimateisthree.
The committee used the GEMS/Food database to prepare updated international estimates of
dietary exposure to steviol glycosides (as steviol). It was assumed that steviol glycosides would
replacealldietarysugarsatthelowestreportedrelativesweetnessratioforsteviolglycosidesand
sucrose, 200:1. The dietary exposures ranged from 0.9 mg/kg bw per day (cluster J) to 5 mg/kg
bwperday(clustersBandM).Thecommitteeevaluatedestimatesofdietaryexposurepercapita
derivedfromdisappearance(poundage)datasuppliedbyJapanandChina(JECFA2009).
TheAFSSAreportedanopiniononanewdraftorderontheuseofrebaudiosideA,anextract
of Stevia rebaudiana ,asafoodadditive.
Manufacturersofbreakfastcereals,cones,andwaferswithnoaddedsugarforicecream,and
dry-saltedappetizersmadefromstarchorwalnutsandhazelnutsdonotsubjectrebaudiosideAtoa
highertemperaturethan100°Ctoavoiditspossiblethermaldegradation.
The maximalist exposure calculations made by AFSSA from the foods corresponding to the
categoriesdeinedinthenewdraftordershowexposureremainsbelowthehumantoxicityvalue
identiiedinhumanstudiesandstipulatedinAFSSA'sopinionexpressedon11September2008.
Accordingtothesecalculations,theadultpopulationwouldbeexposedto0.16mg/kgbw/dayon
theaverageandupto0.93mg/kgbw/dayatthe97.5thpercentile.Inadultconsumersonly,theaver-
ageintakewouldbe0.36mg/kgbw/dayand0.45mg/kgbw/datthe97.5thpercentile.Thehuman
toxicityvalueusedforcomparisonis14.5mg/kgbw/dayforthispopulation(AFSSA2009).