rSSN1817-7077 FAO JECFA Monographs COMPENDIUM OF FOODADDITIVE SPECIFICATIONS JointFAO/WHOExpertCommitteeonFoodAdditives 67thmeeting2006 Copyrightedmaterial ISSN1817-7077 COMPENDIUM OF FOODADDITIVE SPECIFICATIONS JointFAO/WHOExpertCommitteeonFoodAdditives 67thmeeting2006 FOODANDAGRICULTUREORGANIZATIONOFTHEUNITEDNATIONS Rome,2006 Copyrightedmaterial TphroedduecstigdnoatniootnsimepmlpyltohyeeedxparnedsstihoenporfesaennytaotpiionnioonfwthhaetmsaoteevriearloinntthhiespianrftoromfatthieonFood andAgncultureOrganizationoftheUnitedNationsconcerningthelegalordevelopment sdtealtiumsitoaftiaonnyofcoiutnstfrryo,nttieerrristoorry,bociutnydoarneasre.aorofitsauthorities,orconcerningthe ISBN92-5-105559-9 'Aplrlondguchttsforreseedruvceadt.ioRneaplroodrucottihoernnaonnd-cdiosmsmeemricniaatliopnuorfpomsaetserairaelaiuntthhiosnzienfdorwmiatthioount aacnkynpoowolredwgreitdt.enRepperromdiuscstiioonnforfommattheericaolpyirnitghhitsihnoflodrermsatpiroonvipdreoddutchtefsoorurrecsealiesfourlloyther commercialpurposesisprohibitedwithoutwrittenpermissionofthecopyrightholders. Applicationsforsuchpermissionshouldbeaddressedto: Chief ElectronicPublishingPolicyandSupportBranch InformationDivision FAO VialedelleTermediCaracalla,00100Rome.Italy orbye-mailto: [email protected] ©FAO2006 Copyrightedmaterial Ill SPECIALNOTE Whilethegreatestcarehasbeenexercisedinthepreparationofthisinformation,FAO expresslydisclaimsanyliabilitytousersoftheseproceduresforconsequentialdamagesofany kindarisingoutof,orconnectedwith,theiruse. This One 1 V TABLEOFCONTENTS Listofparticipants vii Introduction xi SpecificationsForCertainFoodAdditives 1 AnnattoExtracts(alkali-processednorbixin,acid-precipitated) 3 AnnattoExtracts(alkali-processednorbixin,notacid-precipitated) 5 AnnattoExtracts(aqueous-processedbixin) 7 AnnattoExtracts(oil-processedbixin)Tentative 9 AnnattoExtracts(solvent-extractedbixin) 1 AnnattoExtracts(solvent-extractednorbixin) 13 CCaalrcoibumBeDanL-GmualmatTeentative 1197 CarobBeanGum(clarified)Tentative 23 GuarGumTentative 27 GuarGum(clarified)Tentative 31 Lycopene(synthetic) 35 LycopenefromBlakesleaTrispora 41 DL-malicacid 45 SodiumhydrogenDL-malate 47 SodiumDL-Malate 49 Titaniumdioxide SI Zeaxanthin(synthetic) 57 Withdrawalofspecificationsforcertainfoodadditives 61 Generalspecificationsandconsiderationsforenzymesusedinfoodprocessing 63 Analyticalmethods 69 Nnrhixin 69 Triphenylphosphineoxide 71 Staphylococcusaureus-Directplatecountmethod 72 Afanrntheexri1n:fSorummamtiaornyroefqurierceodmmendationsfrom67'”JECFAand 79 Corrigendum 85 Copyrightedmaterial ) LISTOFPARTICIPANTS JOINTFAOAVHOEXPERTCOMMITTEEONFOODADDITIVES,67thMEETING Rome,20-29June,2006 Members ProfGabrielAdcgokc,DepartmentofFoodTechnology,UniversityofIbadan,Ibadan, Nigeria ProfJohnR.Bend,SchoolofMedicineandDentistry,UniversityofWesternOntario,London, Ontario,Canada DrMikeBolger,USFoodandDrugAdministration,CollegePark,MD,USA DrYokoKawamura.NationalInstituteofHealthSciences,Tokyo,Japan DrAdaKnaap.NationalInstituteofPublicHealthandtheEnvironment.Bilthoven,The Netherlands DrPaulM.Kuznesof,USFoodandDrugAdministration,CollegePark,MD,USA DrJohnC.Larsen,DanishInstituteofFoodandVeterinaryResearch,Soborg,Denmark (vice-Chairman) DrAntoniaMattia,USFoodandDrugAdministration,CollegePark,MD,USA MrsIngeMcyland,DanishInstituteofFoodandVeterinaryResearch.Soborg.Denmark (Chairman DrMadduriVeerabhadraRao.CentralLaboratoriesUnit,U.A.E.University',A1Ain,United ArabEmirates DrJosefSchlatter,SwissFederalOfficeofPublicHealth,Zurich,Switzerland DrPhilippeVerger,InstitutNationaldelaRechercheAgronomique,Paris.France ProfRonaldWalker,EmeritusProfessorofFoodSciences,Aldershot,Hants,United Kingdom MrsHarrietWallin,NationalFoodSafetyAuthority(EVIRA),Helsinki,Finland DrBrianWhitehouse.Bowdon,Cheshire,UnitedKingdom Secretariat DrSusanBarlow',Brighton,EastSussex,UnitedKingdom(WHOTemporary>Adviser) DrDianeBenford,FoodStandardsAgency,London.UnitedKingdom(WHOTemporary• Adviser) DrRuthCharrondiere,NutritionandConsumerProtectionDivision,FoodandAgriculture Organization,Rome,Italy(FAOStaffMember) Copyrightedmaterial > DrMariadeLourdesCostarrica,NutritionandConsumerProtectionDivision,Foodand AgricultureOrganization,Rome,Italy(FAOStaffMember) DrMichaelDiNovi,USFoodandDrugAdministration,CollegePark,MD,USA(WHO TemporaryAdviser) DrChristopherEFisher,Cambridge,UnitedKingdom(FAOExpert) DrNorikoIscki,JointFAO/WHOFoodStandardsProgramme,SecretariatoftheCodex AlimentariusCommission,FoodandAgricultureOrganization,Rome,Italy ProfFujioKayama,DivisionofEnvironmentalMedicine,JichiMedicalUniversity,Tochi- ken,Japan(WHOTemporary’Adviser) ProfRobertKroes,InstituteforRiskAssessmentSciences,UtrechtUniversity,Soest, Netherlands(WHOTemporaryAch’iser,unabletoparticipate) DrCharlesA.Lawrie,FoodStandardsAgency,London,UnitedKingdom(FAOExpert) DrJean-CharlesLeblanc,FrenchFoodSafetyAgency(AFSSA),MaisonsAlfort,France (WHOTemporary’Adviser) DrCatherineLeClercq,NationalResearchInstituteforFoodandNutrition(INRAN),Rome, Italy(FAOExpert) DrHeidiMattock,TechnicalEditor,Illkirch-Graffenstaden,France(WHOTemporary Adviser) DrGeraldMoy,FoodSafetyDepartment,WorldHealthOrganization,Geneva,Switzerland (WHOStaffMember) DrIanC.Munro,CanToxHealthSciencesInternational,Mississauga.Ontario,Canada(WHO TemporaryAdviser) DrAkiyoshiNishikawa,DivisionofPathology,NationalInstituteofHealthSciences.Tokyo, Japan(WHOTemporaryAch’iser) DrZofiaOlempska-Beer,USFoodandDrugAdministration.CollegePark,MD,USA(FAO Expert) DrBarbaraPetersen,Exponent.WashingtonDC,USA(WHOTemporary’Adviser,unableto participate) MrsMaijaEJ.Pronk,CenterforSubstancesandIntegratedRiskAssessment,National InstituteforPublicHealthandtheEnvironment,Bilthoven,TheNetherlands(WHO Temporary’Adviser) ProfAndrewG.Renwick,ClinicalPharmacologyGroup,UniversityofSouthampton, Southampton,UnitedKingdom(WHOTemporary’Ach’iser) DrNiekSchelling,MinistryofAgriculture.NatureandFoodQuality,TheHague,Netherlands (WHOTemporary’Adviser,participatedonlyJune2(fh) Copyrightedmaterial DrKlausSchneider.Forschungs-undBcratungsinstitutGefahrstoffe(FoBiG),Freiburg. Germany(WHOTemporary’Adviser) DrJamesSmith,PrinceEdwardIslandFoodTechnologyCentre,Charlottetown,Canada(FAO Expert) DrDebraStreet,USFoodandDrugAdministration,CollegePark.MD,USA(WHO Temporary'Adviser) DrAngelikaTritschcr,InternationalProgrammeonChemicalSafety,WorldHealth Organization,Geneva,Switzerland(WHOJointSecretary) ProfLuciaMariaValentaSoares,Campinas,Brazil(FAOExpert) MsAnniedeVeer,MinistryofAgriculture,NatureandFoodQuality,TheHague,Netherlands (WHOTemporaryAdviser,participatedonlyJune2Or) DrAnnikaWennberg,NutritionandConsumerProtectionDivision,FoodandAgriculture Organization.Rome.Italy(FAOJointSecretary) ProfGaryMWilliams,EnvironmentalPathologyandToxicology,NewYorkMedical College,Valhalla,NY,USA(WHOTemporary•Achiser) Copyrightedmaterial INTRODUCTION T6h7ithsmveoeltuimnegoofftFhAeOJoiJnEtCFFAAOM/oWnHogOraEpxhpesrctoCntoamimniststpeeeciofincaFtoioodnsAodfdiitdeinvteisty(JaEnCdFpAu)r,ithyeplrdeipnarReodmaettohne 20-29June2006.Inaddition,threegeneralanalyticalmethodswerepreparedandincludedinthis publication.ThespecificationsmonographsarconeoftheoutputsofJECFA’sriskassessmentoffood additives,andshouldbereadinconjunctionwiththesafetyevaluation,referencetowhichismadein thesectionattheheadofeachspecificationsmonograph. Furtherinformationonthemeeting dwsiuhsbicscuthsasniwcoielnslsccboanensipbdueebrlfeiodsuhanetddthiiennmtethheeetsiuWnmgHmwOailrlyTbeercehppnouirbctlaiolsfheRtdehepionmrettheetsicWrnigHesO(.seTFeooxAoindcnoAledoxdgii1tc)ia,vleanmSdeorniionesgt.rhaepfhusllorfepotrhte SpecificationsmonographspreparedbyJECFAatearliersessions,otherthanspecificationsfor Sfpleacviofuirciantgiaognesnwtsh,icahreipsutbhleisfhiresdtipnubcloincsaotliiodnatinedthfeorsmeriinesthFeACOomJbEiCnFeAdCMoonmopgernadpihusm.oTfhFisoopdubAldidciattiivoen consistoffourvolumes,thefirstthreeofwhichcontainthespecificationsmonographsontheidentity aannddpluarbiotryatoofrythseolfuotoidonasddrietqiuviersedanadndthreeffoeurretnhcevdolinumtheecsopnetcaiifniscatthieonasnamloyntiocgarlampehtsh.odFs,AOtesmtapirnotcaeidnusraens ohbtnat-cpl:ki/g;nrewowuwsn.edafriacnohf.aoobrrlmgea/taigod/naagtinan/biaEesncegflai-soahfd,diFtJrieEvnCecsFh,sAeSaprsacpnhei.cshihtf,miclAa?rtlaiaboningcs=aennmdo.nCohTighnreeaspdeha.tsabawsheichhasaisquaevrayilpaabgleeaantd: ThespecificationsforflavouringagentsevaluatedbyJECFA,andpreviouslypublishedinFAOFood andNutritionPaper52andsubsequentAddenda,arenotincludedintheprintedcompendium,withthe exceptionofthosefewwhichhaveanadditionalnon-flavourtechnologicalfunction,theyarcincluded in an online searchable database at the JECFA website at FAO. http:,/anns3.fao.org/iecfa/flavagents/flavag-Q-isn?language^cn. Anaccountofthepurposeandfunctionofspecificationsofidentityandpurity,theroleofJECFA specificationsintheCodexsystem,thelinkbetweenspecificationsandmethodsofanalysis,andthe formatofspecifications,aresetoutintheIntroductiontotheCombinedCompendium,whichis availableinshortenedformatonlineonthequerypage,whichcouldbeconsultedforfurther informationontheroleofspecificationsintheriskassessmentofadditives. ChemicalandTechnicalAssessment(CTAs)preparedasbackgrounddocumentationforthemeeting willbemadeavailableonlineathttp^/wAvw.fao.orgesesn/iecfa/chemicalassessmenten.stm. ContactandFeedback MoreinformationontheworkoftheCommitteeisavailablefromtheFAOhomepageofJECFAat wthwiws.pfuabol.iocartgi/oangaagnnd/oitchcefrationpdiccsxreelna.tsetdmt.oRtehaedwerosrkaroefJinEvCitFeAdttoo:addresscommentsandquestionson iccfatefao.org Copyrightedmaterial 1 SPECIFICATIONSFORCERTAINFOODADDITIVES Newandrevisedspecifications New(N)orrevised(R)specificationsmonographswerepreparedforthefollowingfoodadditives: Acetylatedoxidizedstarch(R) Annattoextracts(alkali-processednorbixin,acid-precipitated) Annattoextracts(alkali-processednorbixin,notacid-precipitated)(R) Annattoextracts(aqueous-proccsscdbixin)(R) Annattoextracts(oil-processedbixin)(R)Tentative Annattoextracts(solventextractedbixin)(R) Annattoextracts(solventextractednorbixin)(R) CalciumDL-malate(R) Carobbeangum(R)Tentative Carobbeangum(clarified)(N)Tentative Guargum(R)Tentative Guargum(clarified)(N)Tentative Lycopene(synthetic)(N) LycopenefromBlakesleatrispora(N) DL-malicacid(R) Maltitol(R) SodiumhydrogenDL-malate(R) SodiumDL-malate(R) Titaniumdioxide(R) Zeaxanthin(synthetic)(R) Thespecificationsmonographsarefoundbelow,withtheexceptionofthoseforacetylatedoxidized starchandmaltitol.Asregardsacetylatedoxidizedstarch,theCommitteewasinformedofanerrorin tTfihnoheretcmhuoeCrdorCimefomnimtiebtdsitpnseetceeaidfraiccgchraeotsemiepiodnnesnttohdfeoicruFoarmAcreeOotcfytFlFaotothoeoedddsaopAnxeddicddiiNifutzitieervddietscitsaoaprrnebccohPix,afypifleciarrst,vtiao5pln2uusbe,AlidFfsrdAhoeeOmnddJi1unE.mt1Ch%F9eAtisonpMe2c1o0i.n0f3o1i%c,g.artaainTpodnhhesrmeopc1nuoob(rgl2ri0ers0ca5htp)eeh.dd sfpoercmiofidciaftiieodnsstmaornchoegsrianpthhefoJrEaCcFetAyloant-eldinoexdiadtiazbeadsestfaorrchfoiosdiandcdliutdievdesin(steheeisnptercoidufcitciaotni)o.nsmonograph Whenthespecificationsforheavymetals(aslead),othermetalsandarsenicinsweeteners,were reviewedbytheCommitteeatits57thmeetingin2001,maltitolwasinadvertentlyomitted.The oCtohmemriptotleyoelsa,grweietdhrweigtahrdthtoemSeetcarlest,araisatp'usblpirsohpeodsailntthoebFriAnOgJthEeCFmaAltMitoonlogsrpeacpihfisca1ti(o2n005in)t.olinewith oInuttshteansdpiecnigfiicnaftoiromnastmioonnoagnrdapahstitmhealtinheavbeybweehnicahsstihginsedinafotremnattatiiovnessthaotuuls,dtbheeresuibsmiintftoerdmattoiotnheonFAthOe JECFASecretariat. NewandrevisedINSnumbersassignedtofoodadditivesbytheCodexAlimentariusCommissionat citosrr2e9stphonsdeisnsgioJnEiCnFA20f0o6o,d(adAdLitIiNveORspMeci0f6ic/a2t9i/o1n2s,moAnpopgernadpihxsXiVnIt)hehoanv-leinbeedeantaibnatsreoaduncdedtheisnetahree notreproducedinthispublication. Copyrightedmaterial