Infant Formula Products.docx

Infant Formula Products.docx

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InfantFormulaProducts

Standard2.9.1

InfantFormulaProducts

Purpose

ThisStandardprovidesforthecompositional,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.

TableofProvisions

Division1–GeneralProvisions

Subdivision1–Interpretation

1Definitions

2Interpretation

Subdivision2–Calculations

3Calculationofenergy

4Calculationofprotein

5Calculationofpotentialrenalsoluteload

Subdivision3–Generalcompositionalrequirements

6Restrictionsandprohibitions

7Permittednutritivesubstances

8Limitonnucleotide5’-monophosphates

9Lacticacidcultures

10Limitonaluminium

Subdivision4–Generallabellingandpackagingrequirements

11Representationsoffoodasinfantformulaproduct

12Prescribednames

13Requirementforameasuringscoop

14Requiredwarnings,directionsandstatements

15Printandpackagesize

16Declarationofnutritioninformation

17Datemarkingandstorageinstructions

18Statementofproteinsource

19Statementondentalfluorosis

20Prohibitedrepresentations

Division2–InfantFormulaandFollow-onFormula

21Composition

22Protein

23Fat

24Vitamins,mineralsandelectrolytes

Division3–InfantFormulaProductsforSpecialDietaryUse

Subdivision1–Infantformulaproductsformulatedforprematureorlowbirthweightinfants

25Compositionandlabelling

26Additionallabelling

Subdivision2–Infantformulaproductsformetabolic,immunological,renal,hepaticandmalabsorptiveconditions

27Composition

28Claims

29Compositionoflactosefreeandlowlactoseformulas

30Claimsrelatingtolactosefreeandlowlactoseformulas

Subdivision3–Infantformulaproductsforspecificdietaryusebaseduponproteinsubstitutes

31Composition

32Protein

33Vitaminsandminerals

34Additionalpermittedtriglycerides

Schedule1Permittedformsofvitaminsandmineralsininfantformulaproducts

Guidelinesforinfantformulaproducts

Clauses

Division1

Subdivision1–Interpretation

1Definitions

（1）Thedefinitionsinclauses1and2ofStandard1.2.8applytothisStandard.

（2）InthisCode–

infantmeansapersonundertheageof12months.

infantformulaproductmeansaproductbasedonmilkorotherediblefoodconstituentsofanimalorplantoriginwhichisnutritionallyadequatetoserveastheprincipalliquidsourceofnourishmentforinfants.

infantformulameansaninfantformulaproductrepresentedasabreastmilksubstituteforinfantsandwhichsatisfiesthenutritionalrequirementsofinfantsageduptofourtosixmonths.

follow-onformulameansaninfantformulaproductrepresentedaseitherabreast-milksubstituteorreplacementforinfantformulaandwhichconstitutestheprincipalliquidsourceofnourishmentinaprogressivelydiversifieddietforinfantsagedfromsixmonths.

lactosefreeformulaandlowlactoseformulameansinfantformulaproductswhichsatisfytheneedsoflactoseintolerantinfants.

pre-termformulameansaninfantformulaproductspecificallyformulatedtosatisfyparticularneedsofinfantsbornprematurelyoroflowbirthweight.

soy-basedformulameansaninfantformulaproductinwhichsoyproteinisolateisthesolesourceofprotein.

mediumchaintriglyceridesmeanstriacylglycerolswhichcontainpredominantlythesaturatedfattyacidsdesignatedby8:

0and10:

0.

proteinsubstitutemeans–

（a）L-aminoacids;or

（b）thehydrolysateofoneormoreoftheproteinsonwhichinfantformulaproductisnormallybased;or

（c）acombinationofL-aminoacidsandthehydrolysateofoneormoreoftheproteinsonwhichinfantformulaproductisnormallybased.

Editorialnote:

Subclause1

（2）isstructuredtoindicatethatthedefinitionsofspecificinfantformulaproductsarewithinthemoregeneral‘infantformulaproduct’definition.Thereforetheusualpracticeoflistingdefinitionsinalphabeticalorderhasnotbeenappliedinthissubclause.

2Interpretation

AreferencetoanyinfantformulaproductinthecompositionalprovisionsofthisStandardisareferenceto–

（a）apowderedorconcentratedformofinfantformulaproductwhichhasbeenreconstitutedwithwateraccordingtodirections;or

（b）aninfantformulaproductin‘readytodrink’form.

Subdivision2–Calculations

3Calculationofenergy

Theenergycontentofinfantformulaproduct,expressedinkilojoules（kJ）,mustbecalculatedusing–

（a）onlytheenergyvaluecontributionsofthefat,proteinandcarbohydrateingredientsoftheinfantformulaproduct;and

（b）therelevantenergyfactorssetoutinStandard1.2.8.

4Calculationofprotein

TheprescribedformulaforthecalculationoftheproteincontentofinfantformulaproductforthepurposesofthisStandardis–

Formula

Formilkproteinsandtheirpartialproteinhydrolysates–

Proteincontent=nitrogencontentx6.38;or

Inanyothercase–

Proteincontent=nitrogencontentx6.25.

5Calculationofpotentialrenalsoluteload

TheprescribedformulaforthecalculationofthepotentialrenalsoluteloadforthepurposesofthisStandardis–

Formula

PotentialrenalsoluteloadinmOsm/100kJ=[Na（mg/100kJ）/23]+[Cl（mg/100kJ）/35]

+[K（mg/100kJ）/39]+[Pavail（mg/100kJ）/31]+[N（mg/100kJ）/28）].

Inthisformula

Pavail=Pofmilk-basedformula+2/3ofPofsoy-basedformulas.

Subdivision3–Generalcompositionalrequirements

6Restrictionsandprohibitions

（1）Avitamin,mineral,foodadditiveornutritivesubstancemustnotbeaddedtoinfantformulaproductunless–

（a）expresslypermittedbythisCode;or

（b）itisnaturallypresentinaningredientoftheinfantformulaproduct.

（2）Infantformulaproductmustcontainnodetectablegluten.

7Permittednutritivesubstances

（1）Anynutritivesubstancelistedincolumn1oftheTabletothisclausemaybeaddedtoinfantformulaproductprovidedthat–

（a）thenutritivesubstanceisinoneormoreoftheformsspecifiedincolumn2oftheTableinrelationtothatsubstance;and

（b）thetotalamountofthenutritivesubstanceintheinfantformulaproductisnomorethantheaddedandanynaturallyoccurringamountspecifiedincolumn4oftheTable.

（2）Thelabelonapackageofinfantformulaproductmustnotincludeanywordsindicating,oranyotherindication,thattheproductcontainsanutritivesubstancespecifiedincolumn1orincolumn2oftheTabletothisclauseunlessthetotalamountoftheaddedandanynaturallyoccurringnutritivesubstanceinthefoodisnolessthantheamountspecifiedincolumn3oftheTable.

Tabletoclause7

Column1

Column2

Column3

Column4

Nutritivesubstance

Permittedforms

Minimumamountper100kJ

Maximumamountper100kJ

Adenosine5′-monophosphate

Adenosine5′-monophosphate

0.14mg

0.38mg

L-carnitine

L-carnitine

0.21mg

0.8mg

Choline

Cholinechloride

Cholinebitartrate

1.7mg

7.1mg

Cytidine5′-monophosphate

Cytidine5′-monophosphate

0.22mg

0.6mg

Guanosine5’-monophosphate

Guanosine5’-monophosphate

Guanosine5’-monophosphatesodiumsalt

0.04mg

0.12mg

Inosine5′-monophosphate

Inosine5′-monophosphate

Inosine5′-monophosphate

sodiumsalt

0.08mg

0.24mg

Lutein

LuteinfromTageteserectaL.

1.5µg

5µg

Inositol

Inositol

1.0mg

9.5mg

Taurine

Taurine

0.8mg

3mg

Uridine5′-monophosphate

Uridine5′-monophosphatesodiumsalt

0.13mg

0.42mg

8Limitonnucleotide5’-monophosphates

Infantformulaproductmustcontainnomorethan3.8mg/100kJofnucleotide5’-monophosphates.

Editorialnote:

Standard1.3.4containsspecificationsfornucleotides.

9Lacticacidcultures

L（+）producinglacticacidculturesmaybeaddedtoinfantformulaproduct.

9APermittedinulin-derivedsubstancesandgalacto-oligosaccharides

（1）Infantformulaproductmaycontainnomorethan–

（a）110mgper100kJofinulin-derivedsubstances;or

（b）290mgper100kJofgalacto-oligosaccharides;or

（c）290mgper100kJofcombinedinulin-derivedsubstancesandgalacto-oligosaccharides,wheretheinulin-derivedsubstancesisnomorethan110mgper100kJ.

（2）Forsubclause

（1）themaximumpermittedamountonlyapplieswhenthesubstancesareadded.Inthatcasethemaximumpermittedamountthenappliestothesumofthenaturallyoccurringandtheaddedsubstances.

10Limitonaluminium

（1）Infantformulaproduct,otherthanapre-termformulaorsoy-basedformulaproduct,mustcontainnomorethan0.05mgofaluminiumper100mL.

（2）Pre-termformulamustcontainnomorethan0.02mgofaluminiumper100mL.

（3）Soy-basedformulamustcontainnomorethan0.1mgofaluminiumper100mL.

Editorialnote:

Standard1.4.1containsthemaximumlevel（ML）ofleadcontaminantininfantformulaproducts.

Subdivision4–Generallabellingandpackagingrequirements

11Representationsoffoodasinfantformulaproduct

Afoodmustnotberepresentedasaninfantformulaproductunlessitcomplieswithth