Chemistry Reference
In-Depth Information
TheEFSAkeepsthesafetyofsweetenersandASPunderregularreview.InMarch2009,the
ANSPanelconcluded,onthebasisofalltheevidencecurrentlyavailable,includingtheEuropean
RamazziniFoundation(ERF)studypublishedin2007,thereisnoindicationofanygenotoxicor
carcinogenicpotentialofASPandnoreasontorevisethepreviouslyestablishedADIforASPof
40 mg/kgbodyweight.Anearlieropinion,followingtheirststudyonASPbytheERF,wasadopted
by the former Scientiic Panel on Food Additives, Flavorings, Processing Aids and Materials in
ContactwithFood(AFC)in2006.
10.7 aSpartaMe
Priortoitsmarketing,thesafetyofthehigh-intensitysweetenerASPforitsintendedusesas
asweetenerandlavorenhancerwasdemonstratedbytheresultsofmorethan100scientiicstud-
iesinanimalsandhumans.Inthepostmarketingperiod,thesafetyofASPwasfurtherevaluated
throughextensivemonitoringofintake,postmarketingsurveillanceofanecdotalreportsofalleged
healtheffects,andadditionalresearchtoevaluatetheseanecdotalreportsandotherscientiicissues
(Butchko and Stargel 2001). The results of the extensive intake evaluation in the United States,
whichwasdoneoveran8-yearperiod,andtheresultsofstudiesdoneinothercountriesdemon-
stratedintakesthatwerewellbelowtheADIssetbytheFDAandregulatorybodiesinothercoun-
tries,aswellastheJECFA.Evaluationoftheanecdotalreportsofadversehealtheffects,theirst
suchsystemforafoodadditive,revealedthereportedeffectsweregenerallymildandalsocommon
in the general population and there was no consistent or unique pattern of symptoms that could
becausallylinkedtoconsumptionofASP.Finally,theresultsoftheextensivescientiicresearch
done to evaluate these allegations did not show a causal relationship between ASP and adverse
effects.Focusedclinicalstudieswouldbethebestwaytothoroughlyaddresstheissuesraisedby
theanecdotalreports.Thus,theweightofscientiicevidenceconirmsthat,eveninamountsthat
peoplemosttypicallyconsume,ASPissafeforitsintendedusesasasweetenerandlavorenhancer
(ButchkoandStargel2001).
ThesafetyofASPanditsmetabolicconstituentswasestablishedthroughextensivetoxicology
studies in laboratory animals using much greater doses than people could possibly consume. Its
safetywasfurtherconirmedthroughstudiesinseveralhumansubpopulations,includinghealthy
infants,children,adolescents,andadults;obeseindividuals;diabetics;lactatingwomen;andindi-
vidualsheterozygous(PKUH)forthegeneticdiseasephenylketonuria(PKU)whohaveadecreased
abilitytometabolizetheessentialaminoacidphenylalanine(Meyer2007).Severalscientiicissues
continuedtoberaisedafterapproval,largelyasaconcernfortheoreticaltoxicityfromitsmetabolic
components—theaminoacids,aspartateandphenylalanine,andmethanol—eventhoughdietary
exposure to these components is much greater than from ASP. Nonetheless, additional research,
includingevaluationsofpossibleassociationsbetweenASPandheadaches,seizures,behavior,cog-
nition,andmood,aswellasallergic-typereactionsandusebypotentiallysensitivesubpopulations,
hascontinuedafterapproval.Theseindingsarereviewedhere.ThesafetytestingofASPhasgone
wellbeyondthatrequiredtoevaluatethesafetyofafoodadditive.WhenalltheresearchonASP,
includingevaluationsinboththepremarketingandpostmarketingperiods,isexaminedasawhole,
itisclearthatASPissafeandtherearenounresolvedquestionsregardingitssafetyundercondi-
tionsofintendeduse(Butchkoetal.2002).
Magnusonetal.(2007)reviewedthescientiicliteratureontheabsorptionandmetabolism,cur-
rentconsumptionlevelsworldwide,toxicology,andrecentepidemiologicalstudiesonASP.Current
uselevelsofASP,evenbyhighusersinspecialsubgroups,remainswellbelowtheU.S.FDAand
EFSAestablishedADIlevelsof50and40mg/kgbw/day,respectively.Consumptionoflargedoses
ofASPinasinglebolusdosewillhaveaneffectonsomebiochemicalparameters,includingplasma
aminoacidlevelsandbrainneurotransmitterlevels.Theriseinplasmalevelsofphenylalanineand
Search WWH ::
Custom Search