Risk Assessment of Sweeteners Used as Food Additives - Sweeteners: Nutritional Aspects, Applications, and Production Technology - page 421

otherchemicalsincommercialuseinthefoodproduction.Theseprincipleswereagreeduponby
theWorldTradeOrganization(WTO)attheUruguayRoundandarelaiddownintheAgreementon
theApplicationofSanitaryandPhytosanitaryMeasures(SPSAgreement).Thisagreementrequires
healthandsafetymeasurestobebasedonsoundscientiicriskassessment.
WTOrecognizestheFoodandAgricultureOrganizationoftheUnitedNations/WorldHealth
Organization(FAO/WHO)CodexAlimentariusCommission(CACor“Codex”)standardsasaref-
erencepointforthesafetyoffoodstuffstradedinternationally(WTO1994).Thesestandardsare
establishedbytheCodexCommitteeonFoodAdditives(CCFA).TheCCFAusestheJointFAO/
WHOExpertCommitteeonFoodAdditives(JECFA)asanadvisorycommitteewithregardtothe
safetyevaluationoffoodadditivesandcontaminants.
In the EU, the European Commission Scientiic Committee for Food (SCF) was the scientiic
guarantorforthesafetyoffoodadditivesinuseuntilMarch2003.Sincethen,thesafetyassessmentof
foodadditiveshasbeentakenoverbytheEuropeanFoodSafetyAuthority(EFSA).WithintheEFSA,
foodadditiveswereevaluatedbytheScientiicPanelonFoodAdditives,Flavorings,ProcessingAids,
andMaterialsinContactwithFood(AFCPanel)untilJuly2008,whenthistaskwastakenoverbythe
ScientiicPanelonFoodAdditivesandNutrientSourcesAddedtoFood(ANSPanel).
14.2 prINCIpLeS OF the SaFetY eVaLUatION OF
SWeeteNerS USeD aS FOOD aDDItIVeS
JECFAissuedprinciplesforthesafetyassessmentoffoodadditivesin1987(WHO1987).These
principleshaverecentlybeenupdated(WHO2009).TheSCFissueditsirstguidanceforthesafety
assessmentoffoodadditivesin1980(SCF1980).In2001,theSCFadopteditsnewguidance(SCF
2001).WithintheEFSAandtheAFCPanelanditsfollowerssinceJuly2008,theANSPanelfor-
mallyadoptedtheSCF'sguidancefrom2001.Anewguidancedocumenthasbeenpreparedbythe
ANSPanelandisexpectedtobeadoptedthisyear(2012).Theguidancedocumentadviceswhich
dataarenecessaryfortheevaluationofthesafetyofachemicalintendedforuseasafoodadditive.
14.3 DataBaSe NeCeSSarY FOr the SaFetY eVaLUatION
OF SWeeteNerS aS FOOD aDDItIVeS
The database to be used for the safety evaluation of a food additive should be provided by the
partyinterestedinobtaininganauthorizationforitsuseinfoodand/orbeverages(apetitioner).Inthe
EU,thedatabaseshouldbepreparedinaccordancewiththeguidanceonsubmissionforfoodadditive
evaluations,whichareadoptedbytheEFSAatthetimeofsubmission.Thesubmission,referredtoas
a“dossier,”shouldprovideadministrativedata,technicaldata(e.g.,identityofthesubstance,purity,
proposedspeciications,stabilityandbreakdownproducts,methodsofanalysisinfoods,andmanu-
facturingprocess),apresentationoftechnicalneed,proposedapplicationsandlevelsofuseindifferent
foodcategories,theestimatedexposureofconsumersresultingfromtheproposedusesanduselevels,
andbiologicaldata.Thelatterincludesresultsfromstudiesonabsorption,organandtissuedistribution,
metabolism,andexcretion(ADME)inanimalsandhumansandfromthetoxicologicalstudies in vitro
(bacteriaandcellcultures)andinlaboratoryanimals( in vivo testing).
14.4 tOXICOLOGICaL teStING
Theaimoftoxicologicaltestingistodeterminewhetherthecompound,whenusedintheman-
nerandquantitiesproposed,wouldposeanyappreciablerisktothehealthoftheaverageconsumer