EU, U.S., and Third World Country Regulations and Japanese Legislation - Sweeteners: Nutritional Aspects, Applications, and Production Technology - page 308

Unfortunately,whenreportingtheoutcomesofthismeeting,theorganizersofthehearingcon-
tinuetorepeaterrorsandmisinformation.TheEFSAreafirmsthatanypossiblerisksfromASP
havebeenconsideredbyscientiicbodiesworldwideandthecurrentADIensuresconsumersare
protected.
Notwithstanding,theEFSAiscontinuouslymonitoringscientiicliteratureregardingthesafety
ofsweeteners,anditstop-levelindependentexpertsonEFSA'sPanelonFoodAdditivesandNutrient
SourcesAddedtoFood(ANS)arepreparingafurtherscientiicopiniononASP.Asforallareasof
itswork,theEFSAwillcontinuetoliaisewithriskassessorsintheEUmemberstatesandwithfood
safetyagenciesoutsideEuropeinordertobeneitfromthebroadestexpertisepossible.
Inastatementpublishedrecently,theEFSAconcludesthattworecentpublicationsonthesafetyof
artiicialsweeteners,namely,acarcinogenicitystudyinmice(Soffrittietal.2010)andanepidemio-
logicalstudyontheassociationbetweenintakesofartiiciallysweetenedsoftdrinksandincreased
incidenceofpretermdelivery(Halldorssonetal.2010),donotgivereasontoreconsiderprevious
safetyassessmentsofASPorofothersweetenerscurrentlyauthorizedintheEuropeanUnion.The
EFSA'sreviewofthesestudieshasbeencarriedoutincooperationwiththeFrenchAgencyforFood,
Environment,andOccupationalHealthSafety( http://www.FRENCHAAAT2011sa0015EN.pdf ) .
Atitsplenarymeetingon1-2March2011,theEFSAANSPanelwillconsidertheauthority's
statementandthepossibleneedforfurtherworkinrelationtothesestudies.TheEFSAwillcontinue
monitoringthescientiicliteratureinordertoidentifynewscientiicevidenceforsweetenersthat
mayindicateapossibleriskforhumanhealthorwhichmayotherwiseaffectthesafetyassessment
ofthesefoodadditives.
In response to a request for technical assistance from the European Commission, the EFSA
reviewed the publication of Soffritti et al. (2010) on a long-term carcinogenicity study in mice
exposedtotheartiicialsweetenerASPthroughfeed.EFSAscientistsconcludedthat,onthebasis
oftheinformationavailableinthepublication,thevalidityofthestudyanditsstatisticalapproach
cannot be assessed and its results cannot be interpreted. Regarding the design of the study, the
EFSAadvisedthatexperimentalstudiescarriedoutoveranimals'lifetimescanleadtoerroneous
conclusions.Olderanimals,forinstance,aremoresusceptibletoillness,andwhenacarcinogenicity
studyinmiceisextendedbeyondtherecommended104weeks,age-relatedpathologicalchanges
(suchasspontaneoustumors)canappear,whichmayconfoundtheinterpretationofanycompound-
relatedeffects.
The EFSA noted that Swiss mice (used in this study) are known to have a high incidence of
spontaneoushepaticandpulmonarytumorsandtheincreasedincidenceofthesetumorsreportedin
thestudyfallwithinthehistoricalcontrolrangerecordedinthislaboratoryforthesetumorsinthese
mice.Furthermore,thesehepatictumorsinmicearenotregardedbytoxicologistsasbeingrelevant
forhumanriskassessmentwhentheyareinducedbynongenotoxicsubstancessuchasASP.Overall,
theEFSAconcludedthattheindingspresentedbySoffrittietal.(2010)donotprovidesuficient
scientiicevidencetoreconsiderthepreviousevaluationsbytheEFSAonASPthatconcludedon
thelackofgenotoxicityandcarcinogenicityofASP.
TheEFSAalsoassessedthepublicationofHalldorssonetal.(2010),whichreportsindingssug-
gestingthedailyintakeofartiiciallysweetenedsoftdrinksmaybeassociatedwithanincreased
risk of preterm delivery. EFSA concluded there is no evidence available in this study to support
a causal relationship between the consumption of artiicially sweetened soft drinks and preterm
deliveryandadditionalstudieswouldberequiredeithertoconirmorrejectsuchanassociation,as
indicatedbytheauthors.Giventhattheassociationfoundbytheauthorsappearstobeprimarily
relatedtomedicallyinduced(ratherthanspontaneous)pretermdeliveries,theEFSAstressedthat
medicalhistoryandcriteriaonwhichmedicaldecisionstoinducedeliverywerebased,arefactors
thatshouldbeinvestigatedfurther.TheEFSArecommendedfuturestudiesshouldalsoinvestigate
otherimportantconfoundingfactorssuchasexposuretoothersubstancesinthediet,whichmight
haveaneffectonpregnancy( http://www.efsa.europa.eu/en/press/news/ans110228.htm ).