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asparticacidfollowingtheadministrationofASPatdoseslessthanorequalto50mg/kgbwdonot
exceedthoseobservedpostprandially.Acute,subacute,andchronictoxicitystudieswithASPand
itsdecompositionproductsconductedinmice,rats,hamsters,anddogshaveconsistentlyfoundno
adverseeffectofASPwithdosesuptoatleast4000mg/kgbw/day.Criticalreviewofallcarcino-
genicitystudiesconductedonASPfoundnocredibleevidencethatASPiscarcinogenic.Thedata
from extensive investigations into the possibilityof neurotoxiceffects of ASP, in general, do not
supportthehypothesisthatASPinthehumandietwillaffectnervoussystemfunction,learning,
or behavior. Epidemiological studies on ASP include several case-control studies and one well-
conductedprospectiveepidemiologicalstudywithalargecohort,inwhichtheconsumptionofASP
wasmeasured.ThestudiesprovidenoevidencetosupportanassociationbetweenASPandcancer
inanytissue.TheweightofexistingevidenceisthatASPissafeatcurrentlevelsofconsumptionas
anonnutritivesweetener.
Butchkoetal.(2002)alsoreportedthattheconversionofASPtomethanolisnotsuficientto
induceanytoxicityfrommethanoloritsmetabolites.
TheFDAevaluatedthesafelevelsofmethanolintakeandconcludedthatthesafelevelofexpo-
suretomethanolis7.1-8.4mg/kgbodyweight/day(FDA1996).Thisamountofmethanolisabout
25timesgreaterthantheamountofmethanol(0.3mg/kgbodyweight)providedbyASPtothediet
atthe90thpercentileintake.
The Advisory Forum (AF) of the EFSA discussed the issue of ASP in 2007, and at the 24th
AFmeetingheldonDecember6and7in2007,itwasagreedthataspecialmeetingwouldbeheld
onASP.Thismeetingofnationalexpertswastotakeplaceearlyin2009and,asprovidedinthe
TermsofReferenceendorsedbytheAF,wastoreviewtheinformationavailableonASP,agreeon
thecompletenessoftheinformation,ensuringanymissingdatawereadded,andidentifypossible
datagapsanddiscrepanciesintheavailabledataandwheresuchexisttoconsiderdetailedoptions
toaddresstheoutstandingissues.
Anorganizingteam,nominatedbymembersoftheAF,wastaskedwithpreparingforthemeet-
ingsofnationalexpertsbyidentifying,collating,andreviewingallpublishedpapersonASPsince
thereviewcarriedoutbytheSCFin2002.Inaddition,theorganizingteamalsoconsideredavail-
able nonpeer-reviewed information and anecdotal claims by individuals who attributed various
symptomsandillnessesdirectlytoASPconsumption.Ameetingwasheldwithinterestedparties
whohadsubmittedinformationinresponsetoacallfordatapublishedbytheEFSAinSeptember
2008.
Each of the areas considered, including exposure data, brain function, satiation and appetite,
allergenicityandimmunotoxicity,metabolicaspectsanddiabetes,carcinogenicity(includingcan-
cer epidemiology), and genotoxicity were considered and reported by the organizing team. For
each,consistentwiththetermsofreferenceforthenationalexpertsmeeting,theymadepreliminary
conclusionsonwhetherthereweredatagapsordiscrepanciesthatrequiredfurtherconsideration.
Thissectionrepresentstheresultsofthesedeliberations.
Overall,theorganizingteamdidnotidentifyanymajorgapsininformationonASP,andthe
nationalexpertsagreedwiththeirview.However,severalsuggestionsaremadewithinthisreport
foradditionaldatathatwouldaddtotheavailableknowledgeonASPanditsmetabolites.Toaddress
the communications element of the terms of reference, a workshop with stakeholders and other
interestedpartiesistobearrangedtoshareanddiscusstheindingsofthework.
Inconclusion,thenationalexpertshavenotidentiiedanynewevidencethatrequiresarecom-
mendationtotheEFSAthatthepreviousopinionsoftheEFSAandtheSCFneedtobereconsidered
(EFSAreportofthemeetingsonASPwithnationalexpertsEFSAQ-2009-00488).
Following a request from the European Commission, the ANS Panel was asked to deliver a
scientiicopinionontheresultsofalong-termcarcinogenicitystudywithprenatalexposuretothe
artiicialsweetenerASP,performedbytheCesareMaltoniCancerResearchCenteroftheEuropean
RamazziniFoundation(ERF)andpublishedinJune2007bySoffrittietal.Theauthorsconcluded
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