Risk Assessment of Sweeteners Used as Food Additives - Sweeteners: Nutritional Aspects, Applications, and Production Technology - page 429

14.7.1.8 Sucralose (E955)
TheSCFexpresseditsirstopiniononsucralosein1989(SCF1989).Atthattime,theSCFcon-
sideredsucralosetobetoxicologicallyunacceptable,asseveraloutstandingquestionsemergedfrom
theevaluationoftheavailabledata.In2000,theSCFconsideredfurtherstudiesandestablishedan
ADIof0-15mg/kgbw(SCF2000c).
TheJECFAreviewedthesafetyofsucraloseontwooccasions.Atits33rdmeeting,thecommit-
teeallocatedatemporaryADIof0-3.5mg/kgbw/daybasedonaNOELof750mg/kgbw/dayina
1-yeardogstudyandanuncertaintyfactorof200(JECFA1988a,b).TheJECFArequestedfurther
data on absorption and metabolism in humans after prolonged oral dosing, studies to show that
sucralose produced no adverse effects on individuals with insulin-dependent and maturity-onset
diabetes, studies on the elimination of sucralose from pregnant animals and the fetus to exclude
bioaccumulation,andashort-termstudyononeofthepotentialintermediatesinthemetabolism
ofsucralose.FurtherstudiesonsucralosewereevaluatedbytheJECFAin1991(JECFA1991a,b),
andanADIof0-15mg/kgbw/daywasallocatedbasedonaNOAELof1500mg/kgbw/dayfroma
long-termstudyinrats,whichincluded in utero exposure,andanuncertaintyfactorof100.
14.7.1.9 Thaumatin (E957)
The SCF expressed its opinion on thaumatin for the irst time in 1984, found the sweetener
temporarilyacceptable,andrequestedadditionaldataonpossiblereceptorbindingandendocrine
activity(SCF1985).Afterconsideringtheadditionaldata,theSCFfoundthesweeteneracceptable
(SCF1989).
TheJECFAevaluatedthaumatinin1983(JECFA1983a),butnoADIwasallocatedatthattime.
In1985,theJECFAallocatedanADInotspeciied(JECFA1985a,b).
14.7.2 Bulk Sweeteners (polyols)
All the polyols authorized for food use as sweeteners in the EU have been allocated an ADI
acceptablebytheSCFortheAFCPanel(Table14.1).
TheSCFexpresseditsopiniononmostpolyolsthatareusedasfoodadditivesintheEUin1984
(SCF1985).TheSCFconsideredadditionalinformationonisomalt(E953)andlactitol(E966)in
1988 (SCF 1989). The SCF evaluated maltitol syrup with a new speciication in 1999 and found
thecontinueduseofthecompoundacceptable(SCF1999b).In2006,theAFCPanelexpressedits
opinion on a new production method for maltitol (EFSA 2006a). The SCF published an opinion
onerythritol(E968)in2003(SCF2003).In2010,theANSPanelprovidedascientiicopinionon
thesafetyoferythritolinlightofapediatricstudyonthegastrointestinal(GI)tolerabilityofthe
compound.TheANSPanelconcludedthattherewasasafetyconcernwithrespecttoGItolerability
fortheuseoferythritolinbeveragesatamaximumuselevelof2.5%fornonsweeteningpurposes
(EFSA2010b).
TheJECFAhasevaluatedpolyolsonseveraloccasions.Atpresent,allthepolyolsusedassweet-
enersandevaluatedbytheJECFAhavereceivedanADInotspeciied(Table14.1).
Erythritol(E968)wasevaluatedbytheJECFAatits53rdmeetingin1999(JECFA1999a,b).
Isomalt(E953)wasevaluatedontwooccasions.In1981,isomaltwasallocatedatemporaryADI
of0-25mg/kgbw/daybasedonaNOELwithrespecttolaxation(JECFA1981a,b),butthisADI
waslaterchangedto“notspeciied”(JECFA1985a,b).
Lactitol(E966)wasevaluatedin1983(JECFA1983a,b).
Maltitol (E965) was evaluated several times. In 1980, the available information was found
inadequateforevaluation(JECFA1980a).In1983,atemporaryADIof0-25mg/kgbw/daywas