Risk Assessment of Sweeteners Used as Food Additives - Sweeteners: Nutritional Aspects, Applications, and Production Technology - page 430

allocatedforhydrogenatedglucosesyrup,withmaltitolbeingamaincomponentof50%-90%ofthe
product.Atthesametime,theJECFArequestedthatdatafromalifetimefeedingstudyshouldbe
madeavailable(JECFA1983a).Then,in1985,theADIformaltitolwaschangedto“notspeciied,”
andtheJECFAfoundthatthepreviouslyrequestedlifetimestudywasnotneeded(JECFA1985a,b).
Finally,in1988,theJECFAchangedthenamehydrogenatedglucosesyruptomaltitolsyrup,and
theADInotspeciiedwasconirmedandalsoextendedtocovermaltitolaswell(JECFA1988a).In
1993,theJECFAreviewedalong-termcarcinogenicitystudyinratsandconirmedtheexistingADI
(JECFA1993a,b).Finally,in1997,theADInotspeciiedwasconirmed,andtheJECFAconcluded
thatthisADIcouldbeappliedtomaltitolsyrupwiththerevisedspeciications(JECFA1997a,b).
Mannitol(E421)wasevaluatedbytheJECFAonseveraloccasions.AtemporaryADIof0-50
mg/kgbw/daywasallocatedin1974(JECFA1974).ThisADIwasretainedin1976(JECFA1976)
andextendeduntil1986(JECFA1985a),wheninallyanADInotspeciiedwasallocated(JECFA
1986a,b).
Sorbitol(E420)wasevaluatedbytheJECFAseveraltimes.Theirstevaluationledtothealloca-
tionofanADInotspeciied(JECFA1973a,b),whichwaschangedtoatemporaryADInotspeci-
iedin1978andconirmedin1980(JECFA1978a,b,1980a,b).Finally,anADInotspeciiedwas
establishedin1982(JECFA1982a).
Xylitol(E967),whenevaluatedin1977(JECFA1977)andin1978,wasnotallocatedanADI,
asthedatawereinsuficient(JECFA1977).In1983,anADInotspeciiedwasestablished(JECFA
1983a,b).
Polyolbulksweetenershavealaxativeeffectwhenconsumedinexcessiveamountsduetothe
osmoticeffectsofunabsorbedpolyolreachingthecolon.Polyolsdifferinthepotencytocauselaxa-
tion.Forinstance,humantolerancestudiesdemonstratedalaxativeeffectofmannitolatintakelev-
elsaslowas10-20g/day(SCF1985),ofmaltitolat30-50g/day(SCF1985),oflactitolatabout50
g/day(SCF1989),andofsorbitolandxylitolatintakelevelsabove50g/day(SCF1984).Erythritol
causesalaxativeeffectathigherdosesthanotherpolyols(SCF2003;JECFA1999b).Consumption
ontheorderof20g/person/dayofpolyolsisunlikelytocauseundesirablelaxativesymptoms.In
acceptingthecontinueduseofpolyols(ADIacceptable),theSCFemphasizedthatthisshouldnot
beinterpretedastheacceptanceofunlimiteduseinallfoodsatanytechnologicallevelbutthatthe
laxative effect should be borne in mind (SCF 1985, 1989). Similarly, the JECFA considered that
thefactthatpolyolsexertalaxativeeffectinmanandanimalsathighdosesshouldbetakeninto
accountwhenconsideringappropriatelevelsoftheuseofpolyolsaloneandincombination(JECFA
1983a,1985a,1986a).
14.8 reeVaLUatION OF the SaFetY OF SWeeteNerS
Theriskassessmentofsweeteners(andotherfoodadditives)isbasedontheknowledgeandthe
dataavailableatthetimeofassessment.Whennewtoxicitydatabecomeavailableinthescientiic
literature,nationalexpertsandinternationalexpertcommitteesconsiderthemwithcaution,andthe
reevaluationofthesafetymaybeperformed.Dependingontheoutcome,threescenariosarepos-
sible:theADIcanbesustained,theADIcanbechanged,ortheuseofasweetenerasafoodadditive
canbefoundunacceptable.
Althoughtherewasnoprovisionforperiodicreviewsofthesafetyofthepermittedfoodaddi-
tivesinthepast,someofthesweetenerswereevaluatedbytheSCF/EFSAseveraltimes,whennew
dataornewrequestsforreevaluationwereacquired(i.e.,cyclamate,saccharin,andaspartame).
InDecember2008,anewregulatorypackageonfoodimprovementagentswasadoptedbythe
European Parliament. Regulation (EC) No. 1333/2008 requires that food additives are subject to
safetyevaluationbytheEFSAbeforetheyarepermittedforuseintheEU.Inaddition,itisfore-
seenthatfoodadditivesmustbekeptundercontinuousobservationandmustbereevaluatedbythe