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STANDARDFORINFANTFORMULAANDFORMULASFORSPECIALMEDICALPURPOSESINTENDEDFORINFANTSCODEXSTAN721981ADOPTEDASAWORLDWIDESTANDARDIN1981AMENDMENT1983,1985,1987,2011AND2015REVISION2007FORMERLYCAC/RS721972CODEXSTAN7219812SECTIONAREVISEDSTANDARDFORINFANTFORMULAPREAMBLETHISSTANDARDISDIVIDEDINTOTWOSECTIONSSECTIONAREFERSTOINFANTFORMULA,ANDSECTIONBDEALSWITHFORMULASFORSPECIALMEDICALPURPOSESINTENDEDFORINFANTS1SCOPE11THISSECTIONOFTHESTANDARDAPPLIESTOINFANTFORMULAINLIQUIDORPOWDEREDFORMINTENDEDFORUSE,WHERENECESSARY,ASASUBSTITUTEFORHUMANMILKINMEETINGTHENORMALNUTRITIONALREQUIREMENTSOFINFANTS12THISSECTIONOFTHESTANDARDCONTAINSCOMPOSITIONAL,QUALITYANDSAFETYREQUIREMENTSFORINFANTFORMULA13ONLYPRODUCTSTHATCOMPLYWITHTHECRITERIALAIDDOWNINTHEPROVISIONSOFTHISSECTIONOFTHISSTANDARDWOULDBEACCEPTEDFORMARKETINGASINFANTFORMULANOPRODUCTOTHERTHANINFANTFORMULAMAYBEMARKETEDOROTHERWISEREPRESENTEDASSUITABLEFORSATISFYINGBYITSELFTHENUTRITIONALREQUIREMENTSOFNORMALHEALTHYINFANTSDURINGTHEFIRSTMONTHSOFLIFE14THEAPPLICATIONOFTHISSECTIONOFTHESTANDARDSHOULDTAKEINTOACCOUNTTHERECOMMENDATIONSMADEINTHEINTERNATIONALCODEOFMARKETINGOFBREASTMILKSUBSTITUTES1981,THEGLOBALSTRATEGYFORINFANTANDYOUNGCHILDFEEDINGANDWORLDHEALTHASSEMBLYRESOLUTIONWHA54220012DESCRIPTION21PRODUCTDEFINITION211INFANTFORMULAMEANSABREASTMILKSUBSTITUTESPECIALLYMANUFACTUREDTOSATISFY,BYITSELF,THENUTRITIONALREQUIREMENTSOFINFANTSDURINGTHEFIRSTMONTHSOFLIFEUPTOTHEINTRODUCTIONOFAPPROPRIATECOMPLEMENTARYFEEDING212THEPRODUCTISSOPROCESSEDBYPHYSICALMEANSONLYANDSOPACKAGEDASTOPREVENTSPOILAGEANDCONTAMINATIONUNDERALLNORMALCONDITIONSOFHANDLING,STORAGEANDDISTRIBUTIONINTHECOUNTRYWHERETHEPRODUCTISSOLD22OTHERDEFINITIONSTHETERMINFANTMEANSAPERSONNOTMORETHAN12MONTHSOFAGE3ESSENTIALCOMPOSITIONANDQUALITYFACTORS31ESSENTIALCOMPOSITION311INFANTFORMULAISAPRODUCTBASEDONMILKOFCOWSOROTHERANIMALSORAMIXTURETHEREOFAND/OROTHERINGREDIENTSWHICHHAVEBEENPROVENTOBESUITABLEFORINFANTFEEDINGTHENUTRITIONALSAFETYANDADEQUACYOFINFANTFORMULASHALLBESCIENTIFICALLYDEMONSTRATEDTOSUPPORTGROWTHANDDEVELOPMENTOFINFANTSALLINGREDIENTSANDFOODADDITIVESSHALLBEGLUTENFREE312INFANTFORMULAPREPAREDREADYFORCONSUMPTIONINACCORDANCEWITHINSTRUCTIONSOFTHEMANUFACTURERSHALLCONTAINPER100MLNOTLESSTHAN60KCAL250KJANDNOTMORETHAN70KCAL295KJOFENERGYCODEXSTAN7219813313INFANTFORMULAPREPAREDREADYFORCONSUMPTIONSHALLCONTAINPER100KCAL100KJTHEFOLLOWINGNUTRIENTSWITHTHEFOLLOWINGMINIMUMANDMAXIMUMORGUIDANCEUPPERLEVELSGUL1,ASAPPROPRIATETHEGENERALPRINCIPLESFORESTABLISHINGTHESELEVELSAREIDENTIFIEDINANNEXIIOFTHISSTANDARDAPROTEIN2,3,4UNITMINIMUMMAXIMUMGULG/100KCAL185,630G/100KJ0455,6072FORTHEPURPOSEOFTHISSTANDARD,THECALCULATIONOFTHEPROTEINCONTENTOFTHEFINALPRODUCTPREPAREDREADYFORCONSUMPTIONSHOULDBEBASEDONNX625,UNLESSASCIENTIFICJUSTIFICATIONISPROVIDEDFORTHEUSEOFADIFFERENTCONVERSIONFACTORFORAPARTICULARPRODUCTTHEPROTEINLEVELSSETINTHISSTANDARDAREBASEDONANITROGENCONVERSIONFACTOROF625THEVALUEOF638ISGENERALLYESTABLISHEDASASPECIFICFACTORAPPROPRIATEFORCONVERSIONOFNITROGENTOPROTEININOTHERMILKPRODUCTS,ANDTHEVALUEOF571ASASPECIFICFACTORFORCONVERSIONOFNITROGENTOPROTEININOTHERSOYPRODUCTS3FORANEQUALENERGYVALUETHEFORMULAMUSTCONTAINANAVAILABLEQUANTITYOFEACHESSENTIALANDSEMIESSENTIALAMINOACIDATLEASTEQUALTOTHATCONTAINEDINTHEREFERENCEPROTEINBREASTMILKASDEFINEDINANNEXINEVERTHELESSFORCALCULATIONPURPOSES,THECONCENTRATIONSOFTYROSINEANDPHENYLALANINEMAYBEADDEDTOGETHERTHECONCENTRATIONSOFMETHIONINEANDCYSTEINEMAYBEADDEDTOGETHERIFTHERATIOISLESSTHAN21INTHECASETHATTHERATIOISBETWEEN21AND31THESUITABILITYOFTHEFORMULAHASTOBEDEMONSTRATEDBYCLINICALTESTING4ISOLATEDAMINOACIDSMAYBEADDEDTOINFANTFORMULAONLYTOIMPROVEITSNUTRITIONALVALUEFORINFANTSESSENTIALANDSEMIESSENTIALAMINOACIDSMAYBEADDEDTOIMPROVEPROTEINQUALITY,ONLYINAMOUNTSNECESSARYFORTHATPURPOSEONLYLFORMSOFAMINOACIDSSHALLBEUSED5THEMINIMUMVALUEAPPLIESTOCOWSMILKPROTEINFORINFANTFORMULABASEDONNONCOWSMILKPROTEINOTHERMINIMUMVALUESMAYNEEDTOBEAPPLIEDFORINFANTFORMULABASEDONSOYPROTEINISOLATE,AMINIMUMVALUEOF225G/100KCAL05G/100KJAPPLIES6INFANTFORMULABASEDONNONHYDROLYSEDMILKPROTEINCONTAININGLESSTHAN2GPROTEIN/100KCALANDINFANTFORMULABASEDONHYDROLYSEDPROTEINCONTAININGLESSTHAN225GPROTEIN/100KCALSHOULDBECLINICALLYEVALUATEDBLIPIDSTOTALFAT7,8UNITMINIMUMMAXIMUMGULG/100KCAL4460G/100KJ105147COMMERCIALLYHYDROGENATEDOILSANDFATSSHALLNOTBEUSEDININFANTFORMULA8LAURICANDMYRISTICACIDSARECONSTITUENTSOFFATS,BUTCOMBINEDSHALLNOTEXCEED20OFTOTALFATTYACIDSTHECONTENTOFTRANSFATTYACIDSSHALLNOTEXCEED3OFTOTALFATTYACIDSTRANSFATTYACIDSAREENDOGENOUSCOMPONENTSOFMILKFATTHEACCEPTANCEOFUPTO3OFTRANSFATTYACIDSISINTENDEDTOALLOWFORTHEUSEOFMILKFATININFANTFORMULAETHEERUCICACIDCONTENTSHALLNOTEXCEED1OFTOTALFATTYACIDSTHETOTALCONTENTOFPHOSPHOLIPIDSSHOULDNOTEXCEED300MG/100KCAL72MG/100KJLINOLEICACIDUNITMINIMUMMAXIMUMGULMG/100KCAL3001400MG/100KJ703301GUIDANCEUPPERLEVELSAREFORNUTRIENTSWITHOUTSUFFICIENTINFORMATIONFORASCIENCEBASEDRISKASSESSMENTTHESELEVELSAREVALUESDERIVEDONTHEBASISOFMEETINGNUTRITIONALREQUIREMENTSOFINFANTSANDANESTABLISHEDHISTORYOFAPPARENTSAFEUSETHEYMAYBEADJUSTEDBASEDONRELEVANTSCIENTIFICORTECHNOLOGICALPROGRESSTHEPURPOSEOFTHEGULSISTOPROVIDEGUIDANCETOMANUFACTURERSANDTHEYSHOULDNOTBEINTERPRETEDASGOALVALUESNUTRIENTCONTENTSININFANTFORMULASSHOULDUSUALLYNOTEXCEEDTHEGULSUNLESSHIGHERNUTRIENTLEVELSCANNOTBEAVOIDEDDUETOHIGHORVARIABLECONTENTSINCONSTITUENTSOFINFANTFORMULASORDUETOTECHNOLOGICALREASONSWHENAPRODUCTTYPEORFORMHASORDINARILYCONTAINEDLOWERLEVELSTHANTHEGULS,MANUFACTURERSSHOULDNOTINCREASELEVELSOFNUTRIENTSTOAPPROACHTHEGULSCODEXSTAN7219814LINOLENICACIDUNITMINIMUMMAXIMUMGULMG/100KCAL50NSMG/100KJ12NSNSNOTSPECIFIEDRATIOLINOLEIC/LINOLENICACIDMINMAX51151CCARBOHYDRATESTOTALCARBOHYDRATES9UNITMINIMUMMAXIMUMGULG/100KCAL90140G/100KJ22339LACTOSEANDGLUCOSEPOLYMERSSHOULDBETHEPREFERREDCARBOHYDRATESINFORMULABASEDONCOWSMILKPROTEINANDHYDROLYSEDPROTEINONLYPRECOOKEDAND/ORGELATINISEDSTARCHESGLUTENFREEBYNATUREMAYBEADDEDTOINFANTFORMULAUPTO30OFTOTALCARBOHYDRATESANDUPTO2G/100MLSUCROSE,UNLESSNEEDED,ANDTHEADDITIONOFFRUCTOSEASANINGREDIENTSHOULDBEAVOIDEDININFANTFORMULA,BECAUSEOFPOTENTIALLIFETHREATENINGSYMPTOMSINYOUNGINFANTSWITHUNRECOGNISEDHEREDITARYFRUCTOSEINTOLERANCEDVITAMINSVITAMINAUNITMINIMUMMAXIMUMGULGRE10/100KCAL60180GRE10/100KJ144310EXPRESSEDASRETINOLEQUIVALENTSRE1GRE333IUVITAMINA1GALLTRANSRETINOLRETINOLCONTENTSSHALLBEPROVIDEDBYPREFORMEDRETINOL,WHILEANYCONTENTSOFCAROTENOIDSSHOULDNOTBEINCLUDEDINTHECALCULATIONANDDECLARATIONOFVITAMINAACTIVITYVITAMIND3UNITMINIMUMMAXIMUMGULG11/100KCAL125G11/100KJ0250611CALCIFEROL1GCALCIFEROL40IUVITAMINDVITAMINEUNITMINIMUMMAXIMUMGULMGTE12/100KCAL05135MGTE12/100KJ0121312121MGTEALPHATOCOPHEROLEQUIVALENT1MGDTOCOPHEROL13VITAMINECONTENTSHALLBEATLEAST05MGTEPERGPUFA,USINGTHEFOLLOWINGFACTORSOFEQUIVALENCETOADAPTTHEMINIMALVITAMINECONTENTTOTHENUMBEROFFATTYACIDDOUBLEBONDSINTHEFORMULA05MGTE/GLINOLEICACID182N6075TE/GLINOLENICACID183N310MGTE/GARACHIDONICACID204N6125MGTE/GEICOSAPENTAENOICACID205N315MGTE/GDOCOSAHEXAENOICACID226N3CODEXSTAN7219815VITAMINKUNITMINIMUMMAXIMUMGULG/100KCAL427G/100KJ165THIAMINUNITMINIMUMMAXIMUMGULG/100KCAL60300G/100KJ1472RIBOFLAVINUNITMINIMUMMAXIMUMGULG/100KCAL80500G/100KJ19119NIACIN14UNITMINIMUMMAXIMUMGULG/100KCAL3001500G/100KJ7036014NIACINREFERSTOPREFORMEDNIACINVITAMINB6UNITMINIMUMMAXIMUMGULG/100KCAL35175G/100KJ8545VITAMINB12UNITMINIMUMMAXIMUMGULG/100KCAL0115G/100KJ0025036PANTOTHENICACIDUNITMINIMUMMAXIMUMGULG/100KCAL4002000G/100KJ96478FOLICACIDUNITMINIMUMMAXIMUMGULG/100KCAL1050G/100KJ2512VITAMINC15UNITMINIMUMMAXIMUMGULMG/100KCAL107016MG/100KJ25171615EXPRESSEDASASCORBICACID16THISGULHASBEENSETTOACCOUNTFORPOSSIBLEHIGHLOSSESOVERSHELFLIFEINLIQUIDFORMULASFORPOWDEREDPRODUCTSLOWERUPPERLEVELSSHOULDBEAIMEDFORCODEXSTAN7219816BIOTINUNITMINIMUMMAXIMUMGULG/100KCAL1510G/100KJ0424EMINERALSANDTRACEELEMENTSIRONUNITMINIMUMMAXIMUMGUL17MG/100KCAL045MG/100KJ0117LEVELSMAYNEEDTOBEDETERMINEDBYNATIONALAUTHORITIESCALCIUMUNITMINIMUMMAXIMUMGULMG/100KCAL50140MG/100KJ1235PHOSPHORUSUNITMINIMUMMAXIMUMGULMG/100KCAL2510018MG/100KJ6241818THISGULSHOULDACCOMMODATEHIGHERNEEDSWITHSOYFORMULARATIOCALCIUM/PHOSPHORUSMINMAX1121MAGNESIUMUNITMINIMUMMAXIMUMGULMG/100KCAL515MG/100KJ1236SODIUMUNITMINIMUMMAXIMUMGULMG/100KCAL2060MG/100KJ514CHLORIDEUNITMINIMUMMAXIMUMGULMG/100KCAL50160MG/100KJ1238POTASSIUMUNITMINIMUMMAXIMUMGULMG/100KCAL60180MG/100KJ1443CODEXSTAN7219817MANGANESEUNITMINIMUMMAXIMUMGULG/100KCAL1100G/100KJ02524IODINEUNITMINIMUMMAXIMUMGULG/100KCAL1060G/100KJ2514SELENIUMUNITMINIMUMMAXIMUMGULG/100KCAL19G/100KJ02422COPPER19UNITMINIMUMMAXIMUMGULG/100KCAL35120G/100KJ852919ADJUSTMENTMAYBENEEDEDINTHESELEVELSFORINFANTFORMULAMADEINREGIONSWITHAHIGHCONTENTOFCOPPERINTHEWATERSUPPLYZINCUNITMINIMUMMAXIMUMGULMG/100KCAL0515MG/100KJ012036FOTHERSUBSTANCESCHOLINEUNITMINIMUMMAXIMUMGULMG/100KCAL750MG/100KJ1712MYOINOSITOLUNITMINIMUMMAXIMUMGULMG/100KCAL440MG/100KJ195LCARNITINEUNITMINIMUMMAXIMUMGULMG/100KCAL12NSMG/100KJ03NS32OPTIONALINGREDIENTS321INADDITIONTOTHECOMPOSITIONALREQUIREMENTSLISTEDUNDER313,OTHERINGREDIENTSMAYBEADDEDINORDERTOPROVIDESUBSTANCESORDINARILYFOUNDINHUMANMILKANDTOENSURETHATTHEFORMULATIONISSUITABLEASTHESOLESOURCEOFNUTRITIONFORTHEINFANTORTOPROVIDEOTHERBENEFITSTHATARESIMILARTOOUTCOMESOFPOPULATIONSOFBREASTFEDBABIESCODEXSTAN7219818322THESUITABILITYFORTHEPARTICULARNUTRITIONALUSESOFINFANTSANDTHESAFETYOFTHESESUBSTANCESSHALLBESCIENTIFICALLYDEMONSTRATEDTHEFORMULASHALLCONTAINSUFFICIENTAMOUNTSOFTHESESUBSTANCESTOACHIEVETHEINTENDEDEFFECT,TAKINGINTOACCOUNTLEVELSINHUMANMILK323THEFOLLOWINGSUBSTANCESMAYBEADDEDINCONFORMITYWITHNATIONALLEGISLATION,INWHICHCASETHEIRCONTENTPER100KCAL100KJINTHEINFANTFORMULAREADYFORCONSUMPTIONSHALLNOTEXCEEDTAURINEUNITMINIMUMMAXIMUMGULMG/100KCAL12MG/100KJ3TOTALNUCLEOTIDESLEVELSMAYNEEDTOBEDETERMINEDBYNATIONALAUTHORITIESDOCOSAHEXAENOICACID20UNITMINIMUMMAXIMUMGULOFFATTYACIDS0520IFDOCOSAHEXAENOICACID226N3ISADDEDTOINFANTFORMULA,ARACHIDONICACID204N6CONTENTSSHOULDREACHATLEASTTHESAMECONCENTRATIONASDHATHECONTENTOFEICOSAPENTAENOICACID205N3,WHICHCANOCCURINSOURCESOFLCPUFA,SHOULDNOTEXCEEDTHECONTENTOFDOCOSAHEXAENOICACIDNATIONALAUTHORITIESMAYDEVIATEFROMTHEABOVECONDITIONS,ASAPPROPRIATEFORTHENUTRITIONALNEEDS324ONLYLLACTICACIDPRODUCINGCULTURESMAYBEUSED33FLUORIDEFLUORIDESHOULDNOTBEADDEDTOINFANTFORMULAINA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