Standard 2.9.1 - Infant Formula Products

Issue138Standard2.9.11STANDARD2.9.1INFANTFORMULAPRODUCTSPurposeThisStandardprovidesforthecompositional,andlabellingrequirementsforfoodsintendedorrepresentedforuseasasubstituteforbreastmilk,hereinreferredtoas‘infantformulaproducts’.ThisStandardappliestoallinfantformulaproductswhetherinpowder,liquidconcentrateor‘readytodrink’forms.ThisStandardalsoprovidesforinfantformulaproductsintendedforinfantswithspecialnutritionalrequirements.ThereareGuidelinesforInfantFormulaProductsattheendofthisStandard.TheseGuidelinesdonotformpartofthelegallybindingStandard.Standard1.3.1containsprovisionsrelatingtothefoodadditivespermittedininfantformulaproducts.Standard1.6.1containsthemicrobiologicallimitsinrelationtoinfantformulaproducts.Standard1.3.4containsspecificationsforpermittednucleotidesandaddednutrients.Standard1.1.1definesnutritivesubstancesforthepurposesofthisCode.SeeStandard1.5.1–NovelFoodsforrequirementsfornovelfoodandnovelfoodingredients.TableofProvisionsDivision1–GeneralProvisionsSubdivision1–Interpretation1Definitions2InterpretationSubdivision2–Calculations3Calculationofenergy4Calculationofprotein5CalculationofpotentialrenalsoluteloadSubdivision3–Generalcompositionalrequirements6Restrictionsandprohibitions7Permittednutritivesubstances8Limitonnucleotide5’-monophosphates9Lacticacidcultures10LimitonaluminiumSubdivision4–Generallabellingandpackagingrequirements11Representationsoffoodasinfantformulaproduct12Prescribednames13Requirementforameasuringscoop14Requiredwarnings,directionsandstatements15Printandpackagesize16Declarationofnutritioninformation17Datemarkingandstorageinstructions18Statementofproteinsource19Statementondentalfluorosis20ProhibitedrepresentationsDivision2–InfantFormulaandFollow-onFormula21Composition22Protein23Fat24Vitamins,mineralsandelectrolytesFederalRegisterofLegislativeInstrumentsF2013C00302Issue138Standard2.9.12Division3–InfantFormulaProductsforSpecialDietaryUseSubdivision1–Infantformulaproductsformulatedforprematureorlowbirthweightinfants25Compositionandlabelling26AdditionallabellingSubdivision2–Infantformulaproductsformetabolic,immunological,renal,hepaticandmalabsorptiveconditions27Composition28RequiredstatementsforproductsunderthisSubdivision29Compositionoflactosefreeandlowlactoseformulas30ClaimsrelatingtolactosefreeandlowlactoseformulasSubdivision3–Infantformulaproductsforspecificdietaryusebaseduponproteinsubstitutes31Composition32Protein33Vitaminsandminerals34AdditionalpermittedtriglyceridesSchedule1PermittedformsofvitaminsandmineralsininfantformulaproductsGuidelinesforinfantformulaproductsClausesDivision1Subdivision1–Interpretation1Definitions(1)Thedefinitionsinclauses1and2ofStandard1.2.8applytothisStandard.(2)InthisCode–infantmeansapersonundertheageof12months.infantformulaproductmeansaproductbasedonmilkorotherediblefoodconstituentsofanimalorplantoriginwhichisnutritionallyadequatetoserveastheprincipalliquidsourceofnourishmentforinfants.infantformulameansaninfantformulaproductrepresentedasabreastmilksubstituteforinfantsandwhichsatisfiesthenutritionalrequirementsofinfantsageduptofourtosixmonths.follow-onformulameansaninfantformulaproductrepresentedaseitherabreast-milksubstituteorreplacementforinfantformulaandwhichconstitutestheprincipalliquidsourceofnourishmentinaprogressivelydiversifieddietforinfantsagedfromsixmonths.lactosefreeformulaandlowlactoseformulameansinfantformulaproductswhichsatisfytheneedsoflactoseintolerantinfants.pre-termformulameansaninfantformulaproductspecificallyformulatedtosatisfyparticularneedsofinfantsbornprematurelyoroflowbirthweight.soy-basedformulameansaninfantformulaproductinwhichsoyproteinisolateisthesolesourceofprotein.mediumchaintriglyceridesmeanstriacylglycerolswhichcontainpredominantlythesaturatedfattyacidsdesignatedby8:0and10:0.FederalRegisterofLegislativeInstrumentsF2013C00302Issue124Standard2.9.13proteinsubstitutemeans–(a)L-aminoacids;or(b)thehydrolysateofoneormoreoftheproteinsonwhichinfantformulaproductisnormallybased;or(c)acombinationofL-aminoacidsandthehydrolysateofoneormoreoftheproteinsonwhichinfantformulaproductisnormallybased.Editorialnote:Subclause1(2)isstructuredtoindicatethatthedefinitionsofspecificinfantformulaproductsarewithinthemoregeneral‘infantformulaproduct’definition.Thereforetheusualpracticeoflistingdefinitionsinalphabeticalorderhasnotbeenappliedinthissubclause.2InterpretationAreferencetoanyinfantformulaproductinthecompositionalprovisionsofthisStandardisareferenceto–(a)apowderedorconcentratedformofinfantformulaproductwhichhasbeenreconstitutedwithwateraccordingtodirections;or(b)aninfantformulaproductin‘readytodrink’form.Subdivision2–Calculations3CalculationofenergyTheenergycontentofinfantformulaproduct,expressedinkilojoules(kJ),mustbecalculatedusing–(a)onlytheenergyvaluecontributionsofthefat,proteinandcarbohydrateingredientsoftheinfantformulaproduct;and(b)therelevantenergyfactorssetoutinStandard1.2.8.4CalculationofproteinTheprescribedformulaforthecalculationoftheproteincontentofinfantformulaproductforthepurposesofthisStandardis–FormulaFormilkprote