Risk Assessment of Sweeteners Used as Food Additives - Sweeteners: Nutritional Aspects, Applications, and Production Technology - page 425

14.7 rISK eVaLUatIONS OF the SWeeteNerS
perMItteD FOr FOOD USe IN the eU
The SCF opinions, the JECFA reports, and monographs for sweeteners are publicly available
( http://europa.eu/comm./food/fs/sc/scf/outcome_en.html ; http://www.who.int/foodsafety/chem/jecfa/
publications/en/index.html ) .TheEFSAopiniononsweetenersinwhichsafetywasevaluatedbythe
AFCorANSPanelsarepublishedinthe EFSA Journal andcanbefoundthroughtheEFSAhome
page( www.efsa.europa.eu ).
ThesummaryofthesafetyevaluationsinformoftheADIsofthesweetenersauthorizedfor
fooduseintheEUispresentedinTable14.1.
14.7.1 Intense Sweeteners
14.7.1.1 Acesulfame Potassium (E950)
TheSCFexpresseditsopiniononacesulfameKfortheirsttimein1984andestablishedan
ADI of 0-9 mg/kg bw/day (SCF 1985). The SCF considered the highest level of acesulfame K,
testedinratsanddogsat3%ofthediet,astheNOAELequivalentto1500mg/kgbw/dayinrats
and900mg/kgbw/dayindogs.TheADIwasestablishedbasedondatafromthestudy,inwhich
dogs were found to be the most sensitive species. Subsequently, the safety of acesulfame K was
updatedbytheCommitteein1991(SCF1992)andin2000(SCF2000a).Onbothoccasions,the
SCFwasaskedtoconsiderwhetherthe2-yearstudyinrats(insteadofthe2-yearstudyindogs)
couldbeconsideredabasisfortheADI.However,takingintoaccountpreviouslyavailableandnew
toxicokineticdatainvariousspecies,includingman,andbasedonlimitedevidenceoftoxicokinet-
icssimilaritybetweenhumansanddogsandtheobservationthat,forthesametotaldailydose,the
plasmapeakconcentrationindogsisseveralfoldshigherthanforrats,theSCFconsideredthatdogs
remainedtheappropriatespeciesonwhichtobasetheADIandreafirmeditspreviousADI(SCF
1992,2000a).Additionallyin2000,theSCFconsiderednewmutagenicitystudiesandclaimsthat
theoldlong-termstudiesindicatedthatacesulfameKhadacarcinogenicpotential.TheSCFfound
thatsuchclaimscouldnotbesubstantiatedonthebasisoftheavailabledataandmaintainedthe
ADIof0-9mg/kgbw/day(SCF2000a).
TheJECFAevaluatedacesulfameKfortheirsttimein1981(JECFA1981a,b).NoADIwas
allocated because of shortcomings in the long-term/carcinogenicity studies in mice and rats. In
1983,anADIof0-9mg/kgbw/daywasestablishedbasedonthe2-yeardogstudy(JECFA1983a,b),
whichwasalsoconsideredthepivotalstudybytheSCF(asmentionedabove).In1990,theJECFA
changedtheADIto0-15mg/kgbw/day(JECFA1991a,b).Atthetimeoftheevaluation,theJECFA
consideredthat,becauseacesulfameKwasnotmetabolizedinanyspeciestested,includingman,
andfurtherstudiesinratsinwhichrepeateddosesweregivendidnotrevealanyinductionofmetab-
olismorchangeinpharmacokineticbehavior,ratsappearedtobeanappropriatemodelforhumans.
Consequently, the JECFA decided that the ADI should be based on the no-observed-effect-level
(NOEL)inrats,whichwas1500mg/kgbw/day,sincethe2-yearstudyinratsrepresentedagreater
portionofthelifespanofthespeciesthanthe2-yearstudyindogs,andtheratstudyincludedexpo-
sure in utero (i.e.,fromconceptionandthroughoutgestation).
14.7.1.2 Aspartame (E951)
TheSCFexpresseditsopiniononaspartameandestablishedanADIof0-40mg/kgbw/dayin
1984(SCF1985).In1988,theSCFevaluatednewdataontheeffectsofaspartameonbloodand
tissuelevelsofphenylalanineandthepossibilityofbehavioralandotherneurotoxiceffectsdueto
theconsumptionofaspartame.TheADIwasmaintained(SCF1989).In1997,theSCFexamined