Standard 1.3.4 - Identity and Purity

Issue1351Standard1.3.4STANDARD1.3.4IDENTITYANDPURITYPurposeThisStandardensuresthatfoodadditives,processingaids,novelfoodsubstances,vitaminsandmineralsandnutritivesubstancesaddedtofoodinaccordancewiththisCodemeetappropriatespecificationsforidentityandpurity.Ingeneral,thesespecificationsarethoseusedbytheinternationalcommunity.TableofProvisions1Application2Substanceswithspecificationsinprimarysources3Substanceswithspecificationsinsecondarysources4AdditionalandsupplementaryrequirementsScheduleSpecificationsofidentityandpurityforsubstancesaddedtofoodwheretherearenoreferencesinthemonographsspecifiedinStandard1.3.4Clauses1ApplicationThisStandardappliesonlytothefollowingsubstanceswhichareaddedtofoodinaccordancewiththisCode,orsoldforuseinfood–(a)foodadditives;(b)processingaids;(c)vitaminsandminerals;(d)novelfoodsubstances;and(e)nutritivesubstances.2SubstanceswithspecificationsinprimarysourcesAsubstancemustcomplywitharelevantmonographpublishedinoneofthefollowing–(a)theScheduletothisStandard;or(b)CombinedCompendiumofFoodAdditiveSpecifications,FAOJECFAMonograph1(2005)assupersededbyspecificationspublishedinFAOJECFAMonographs3(2006)andFAOJECFAMonographs4(2007)andFAOJECFAMonographs5(2008)andFAOJECFAMonographs7(2009)andFAOJECFAMonographs10(2010)andFAOJECFAMonographs11(2011),FoodandAgricultureOrganisationoftheUnitedNations.Rome;or(c)FoodChemicalsCodex(8thEdition)publishedbyUnitesStatesPharmacopoeia(2012).3SubstanceswithspecificationsinsecondarysourcesIfthereisnomonographapplyingtoasubstanceunderclause2,thesubstancemustcomplywitharelevantmonographpublishedinoneofthefollowing–(a)theBritishPharmacopoeia2010,TSO,Norwich(2010);or(b)theUnitedStatesPharmacopeia,34thRevisionandTheNationalFormulary,29thEdition(2010);or(c)thePharmaceuticalCodex,12thEdition,CouncilofthePharmaceuticalSocietyofGreatBritain.ThePharmaceuticalPress,London(1994);orFederalRegisterofLegislativeInstrumentsF2013C00137Issue1352Standard1.3.4(d)Martindale;TheCompleteDrugReference.ThePharmaceuticalPressLondon(2009);or(e)theEuropeanPharmacopoeia6thEdition,CouncilofEurope,Strasbourg(2007);or(f)theInternationalPharmacopoeia4thEdition,WorldHealthOrganization,Geneva(2006and2008supplement);or(g)theMerckIndex,14thEdition,(2006);or(h)theCodeofFederalRegulations;or(i)theSpecificationsandStandardsforFoodAdditives,7thEdition(2000),MinistryofHealthandWelfare(Japan);or(j)theInternationalOenologicalCodex(2010supplementaryedition),OrganisationInternationaledelaVigneetduVin(OIV).4AdditionalandsupplementaryrequirementsWherenomonographappliestoasubstancebyvirtueofclauses2or3,orwhereamonographcontainsnospecificationsforidentityandpurityofasubstancerelatingtoarsenicorheavymetals,thesubstancemustnotcontainonadryweightbasismorethan–(a)2mg/kgoflead;(b)1mg/kgofarsenic;(c)1mg/kgofcadmium;(d)1mg/kgofmercury.FederalRegisterofLegislativeInstrumentsF2013C00137Issue1353Standard1.3.4SCHEDULEThisSchedulecontainsspecificationsofidentityandpurityforsubstancesaddedtofoodwheretherearenoreferencesinthemonographsspecifiedinthisStandard.SpecificationforhighchromiumyeastPhysicalTestsAppearance:Fine,free-flowingpowderColour:Lightoff-whiteorlighttanOdour:SlightyeastaromaParticlesize:Min.90%througha#100USSscreenChemicalTestsMoisture:Maximum6%Chromium:1.8-2.25g/kgSpecificationforhighmolybdenumyeastPhysicalTestsAppearance:Fine,free-flowingpowderColour:Lightoff-whiteorlighttanOdour:SlightyeastaromaParticlesize:Min.85%througha#100USSscreenChemicalTestsMoisture:Maximum6%Molybdenum:1.8-2.25g/kgSpecificationforoxidisedpolyethyleneOxidisedpolyethylene(CAS68441-17-8)#isthepolymerproducedbythemildairoxidationofpolyethylene.Averagemolecularweightmin1200(osmometric)Viscosityat125Cmin200cPOxygencontentmax9.1%Acidvalue:max70mgKOH/g(ASTMD1386)*Droppoint:min95C(ASTMD566)*Density(20C)0.93-1.05g/cm3(ASTMD1298,D1505)*Extractableconstituents(Seenote1):inwatermax.1.5%in10%ethanolmax2.3%in3%aceticacidmax1.8%inn-pentanemax26.0%#CASistheChemicalAbstractsService(CAS)RegistryNumber.*ASTMreferstostandardtestmethodspreparedbytheAmericanSocietyforTestingandMaterials.Note1:ExtractionofoxidisedPolyethylene25.0goffinelygroundoxidisedpolyethylenepowder(particlesize300-1000mm)areextractedfor5hoursintheSoxhletapparatuswith350mLofsolvent.Thesolventisthendistilledoffandthedistillationresidueisdriedinavacuumovenat80-90°C.Afterweighingtheobtainedresidue,thecomponentssolubleinthesolventarecalculatedin%weight(basedontheinitialweightused).FederalRegisterofLegislativeInstrumentsF2013C00137Issue1354Standard1.3.4Specificationforbromo-chloro-dimethylhydantoinBromo-chloro-dimethylhydantoin(CASNumber:126-06-7)Formula:C5H6BrCIN2O2Formulaweight:241.5ChemicalPropertiesAppearance:SolidorfreeflowinggranulesColour:WhiteOdour:FainthalogenousodourMeltingPoint:163-164ºCSpecificgravity:1.8-2Solubilityinwater:0.2g/100gat25ºCStability:StablewhendryanduncontaminatedChemicalTestsManufacturingprocess:Soliddimethylhydantoin(DMH)isdissolvedinwaterwithbromineandchlorine.Thereactionis0.5molebromineand1.5molechlorineforonemoleDMH.DuringthereactionthepHiskeptbasicbytheadd