IS 14433: Infant milk substitutes

2007·2.2 MB·English

by  Bureau of Indian Standards

इंटरनेट मानक
Disclosure to Promote the Right To Information
Whereas the Parliament of India has set out to provide a practical regime of right to
information for citizens to secure access to information under the control of public authorities,
in order to promote transparency and accountability in the working of every public authority,
and whereas the attached publication of the Bureau of Indian Standards is of particular interest
to the public, particularly disadvantaged communities and those engaged in the pursuit of
education and knowledge, the attached public safety standard is made available to promote the
timely dissemination of this information in an accurate manner to the public.
“जान1 का अ+धकार, जी1 का अ+धकार” “प0रा1 को छोड न’ 5 तरफ”
Mazdoor Kisan Shakti Sangathan Jawaharlal Nehru
“The Right to Information, The Right to Live” “Step Out From the Old to the New”
IS 14433 (2007): Infant milk substitutes [FAD 19: Dairy
Products and Equipment]
“!ान $ एक न’ भारत का +नम-ण”
Satyanarayan Gangaram Pitroda
““IInnvveenntt aa NNeeww IInnddiiaa UUssiinngg KKnnoowwlleeddggee””
“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता हहहहै””ै”
Bhartṛhari—Nītiśatakam
“Knowledge is such a treasure which cannot be stolen”

IS 14433 : 2007

1m] ~ ~ ~ 3i1.1~-~
)
TRt~
( qiJ(qJ
Indian Standard
INFANT MILK SUBSTITUTES - SPECIFICATION
( First Revision)
res 67.100.99
C 8182007
BUR E A U 0 FIN D I A N S TAN DAR D '8
MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEWDELHI110002

Price Group6
AMENDMENT NO. I AlJ(;lJST 2007
TO
IS 14433: 2007INFANT MILK SUBSTITUTES
SPECIFICATION
( FirstRevision)
(Page 2. clause 6.2, informal table, col I) - Insert 'L (+) Lactic acid
producingcultures' after 'L (+)Lacticacid'.
(Page 2, clause 6.2, informal table, colI) - Insert the following at the
end:
~Antioxidants {
(Mixedtocopherols I mginalltypes
concentrateandL-Ascorbyl ofinfantformulae'
palmitate)
[Page~, clause6.10.I(a), line I]- Substitute ~2.25 gil00kcalto2.75gllOO
kcal'for '2.25 gil00kcal/Jto2.75gil00kcal/J'.
[Page4, clause6.10.3(a)] - Substitute 'whey or casein'for 'casein'.
(FAD 19)
ReprographyUnit,BIS,NewDelhi.India
AMENDMENT NO. 2 MAY 2008
TO.
IS 14433 : 2007'INFANT MILKSUBSTITUTES
SPECIFICATION
(FlntRevision)
[Page5,Table 1,SlNo. (xxi), col2]- Substitute 'Calcium,mg/IOOg,Min'for
'Calcium,mg/lOO'.
(FAD 19)
ReprographyUnit,BIS,NewDelhi,India
FOREWORD
ThisIndianStandard(FirstRevision)wu~ted·bytheBureauoflndianStandards,afterthedraftftnaIizedby
theDairyProductsandEquipmentsSectionalCommitteehadbeenapprovedbytheFoodandAgricultureDivision
Council.
Thisstandardwufirstpublishedin1997andthisrevisionisbeingundertakentoincluderequirementsforlactose
freeinfantmilksubstitutes,lactoseandsucroseheinfantmilksubstitutesandsucrosefreeinfantmilksubstitutes
whichinvolvesubltitUtionofmilkproteinbysoyaprote,inandthereforethedivisionofthestandardintotwoparts
isrenderedunnecessIty.,Inthisrevision,requirements forhypoallergenic infantmilksubstitutes hasalsobeen
includedandthechemicalandmicrobiologicalrequirementsforhypoallergenic.infantmilksubstituteshasalso'
beenincludedandthechemical,andmicrobiologiCalrequirementsupdated. Inviewoftheaboveinclusionsand
updations,thestandardisharmonizedwiththestandardsforinfantmilksubstituteslaiddownunderthePrevention
01FoodAdult,rationRulu, 19'5. \ .
Humanmilkideallyfulfilstheneedforgrowthandadditionallyprovidesuniquebio-inununefactorsforprotecting
thehealthofinfants.Breastfeedingis,therefore,universallyregardedasthemoStappropriatefonnofnourishing
theinfant.However,whenbreastfeedingisDotpossible,reliancehastobeplaceduponthealternatesourcesof
nutrients for infantfeeding. It isimperative thatinfantmilksubstitutes shouldbeproperly formulated sothat
stress
nutritionalrequirementsforoptimalgrowtharemetadequately,andthatthereisminimumofphysiological
onthedevelopingorgansandenzymaticsystemoftheinfant. Itisequallyimportanttopromotecorrectfeeding
practices,sothatappropriateuseoftheinfantmilksubstitutecouldbemadeforprotectingthehealthoftheinfant.
Underthe InfantMilk Substitute" Fetdlng80ftkl andIn/antFoods (Regulation ofProduction, Supplyand
Distribution)Act,1992,varioustypesoffoodsforinfantsbeingmarketedinourcountryhavebeenplacedunder
thefollowingtwocategories: -
a) Infantmilksubstitutes,and
b) Infantfoods.
'Infantmilksubstitute'meansanyfoodbeingmarketedorotherwiserepresentedaspartialortotalreplacement
formother'smilk,whereas'Infantfood'meansanyfoodbeingmarketedorotherwiserepresentedasacomplement
tomotJter'amilktomeetthegrowingnutritionalneedsoftheinfantaftertheageofsixmonths.
Earlier,therequirementsofinfantmilksubstituteswerecoveredunderseparatestandards,namely,IS1547:1985
'Infant milkfood'andIS 11156: 1985'Infant formulae'.ID orderto-alip with the IllftmtMilk. Sub,titMtu,
Feedln'BottlestIIIdInfantFoods(Rtgulatloll01Prodactioll,SupplyandDi#ribution)Act,1992,theeestandards
wererevised andama1pmlted into onecomprehensivestandard, IS 14433 (Part 1)and IS1547andIS 11156
werecoaaequentlywithdrawn. IS14433(part 1)coveredinfantmilksubstituteswhichweremilkpr~einbased
andPII12ofthestaIldardwasintendedtocovervegetableproteinbasedinfantmilksubstitutes,whichhowever
wunotformulated. Withthepublicationofthisstandard,IS14433(part 1): 1997standcancelled.
ThefintnvisioaofIS14433isbeingundertakentoincluderequirementsfQrlactosefreeinfantmilksubstitutes,
lactoseandsucrosefreeinfantmilksubstitutesandsucroseheinfantmilksubstituteswhichinvolvesubstitution .
ofmilkprotirinbysoyaproteinandtherefore.tb'divisionofthestandard'Intotwopartsisrendered_ .
Inthisrevision,requirementsforbypoallergenicinfantmilksubstitutesbasalsobeenincludedandthechemical
andmicrobiological requirementsupdated. Inviewofthe above inclusions and updatioDs, the standardis
harmonizedwiththestandardsforin&ntmilksubstituteslaiddownUDderthePl'fWIt.tlon01FoodAt!-lIeration
Ruk8, 1955.
WhilefomiuJadngthisItIDdard,etuecoasidendonbatbeeD&iWDtotherelovatrut.~'bytheOo¥emment. .
of India, namelyPrtlVmtioil ofFoOdAdIdIcftJliDlI RuM',1955; III'"Milk SubltitMu" FHd"., Bottla,and "
(~.WnJ~r)
"":
IS14433: ZOO7.
Indian Standard
INFANT MILK SUBSTITUTES - SPECIFICATION
( First Revision)
1 SCOPE 3.4 Routine'Jests- Testscarriedoutoneachlotto
checktheessentialrequirementswhichare likelyto
This standard prescribes the types, requirements,
varyduringproduction.
methodsoftestandsamplingforinfantmilksubstitutes.
3.5 TypeTest- Theteststoproveconformitytothe
2 REFERENCES
requirementsofthis standard. They are intendedto
The standards listed in AnnexAcontain provisions approvethefonnulationandqualityoftheproductat
which through reference in this text, constitute leastinthebeginningofmarketingorcertification or
provisionsofthisstandard.Atthetimeofpublication, both. These tests are also conductedperiodicallyto
the editions indicated were valid. All standards are supplement the routine tests or wheneverthe basic
subjecttorevisionandpartiestoagreementsbasedon formulaormethodischanged.
this standard are encouraged to investigate the
possibilityofapplyingthemostrecenteditionsofthe 4 TYPES
standardsindicated.
4.1 Thematerialshallbeofthefollowingtwotypes:
3 TERMINOLOGY a) 'TYpe1-Infantmilkfood,and
3.0 For the purpose ofthis standard, the following b) Type11-Infantformula including:
definitionsshallapply.
1) Infantformula;
3.1 InfantMDkFood- Thematerialaspreparedby 2) Pre-maturelLowbirthweightinfantmilk
spraydryingofthemilkofcoworbuffalooramixture substitute;
thereof. The milk may be modified by the partial
3) Lactose free infant milk substitute,
removal/substitution of different milk solids,
lactose and sucrose free infant milk
carbohydratessuchassucrose,dextroseanddextrinsl
substitute and sucrose free infantmilk
maltodextrins, maltose and lactose, salts such as
substitute;and
phosphates,citrates;vitaminsA,D,E,Bgroup,C,and
4) Hypoallergenic infantmilksubstitute.
other vitamins,minerals such asiron, copper, zinc,
iodineandothers.
S DESCRIPTION
3.2 InfaDt Formula- The materialas preparedby
Theproductshall bewhiteor whitewitha greenish
spraydryingofthemilkofcoworbuffalooramixture
tingetolightcreamincolour,treefromlumpsandshall
thereof. The milk may be modified by the partial
be uniforminappearance.
removal/substitutionofmilkfatwithediblevegetable
oils rich in polyunsaturated fatty acids andlor by
6 REQUIREMENTS
different milk solids, either singly or in a suitable
combination;carbohydratessuchassucrose,dextrose 6.1 1YPe I Infant milk substituteshall be free from
anddextrinslmaltodextrins, maltoseandlactose;salts starchandaddedantioxidantswhileinTypeII,ready
suchasphosphates,citrates;vitaminsA,0,E,B,group todrinkinfantmilksubstitute,lecithin(see ISSOS5)
C,andothervitamins;mineralssuchas Iron,copper, andascorbylpalmitate(seeIS13462)maybeusedup
zinc,iodineandothers. toamaximum limitof0.5gil00mland 1mgt100ml
respectivelyandshallbefreefromstarch.Itshallalso
NOTE- Infantformulameantforpremature infants(born
befreefromdirt,andextraneousmatter,preservatives,
before37weeks)orinfantswithlowbirthwei~t(less than
2500I)andsuitablymodifiedwithadditionofproteins,whey addedcolourandflavourandfromanymaterialwhich
proteins,minerals10IS toachievetherequiredwhey:casein arehannfultoinfant'shealth.
ratio;calcium:phosphorusratioaIonIwithotherrequirements,
IS liven inthestandard,shallbetermed u PrematurclLow 6.2 1YPeIInfantmilksubstituteshallnotcontainfood
birthwei",t infantmilksubstitute.
additives.TypeII Infantmilksubstitutemay contain
3.3 Waat- Achildnotmorethan12monthsofage. foodadditiveslistedbelow:
,IS14433:2007
q) Cholesterol :Notlessthan88mgll
FoodAdditives Maximum Levelin
100ml ofthe Ready-to r) LipidPhosphorus :Notlessthan7mgII
DrinkProduct
s) Prostaglandins :NotlessthanPOEISOmgIl
pH-AdjustingAgents:
NotlessthanPOF400m!VI
Sodiumhydroxide
Sodium hydrogen Whenanyof thesenutrients isadded,the amountof
carbonate Limited by good these added nutrients shall be declared on the label,
Sodiumcarbonate manufacturing practice whichshouldnotbelessthanmentioned.Itmaycontain
Potassiumhydroxide andwithinthelimitsfor mediumchaintriglycerides,taurine,molybdenumand
Potassiwnhydrogen sodium and potassium
chromium.
carbonate in all types of infant
Potassiumcarbonate fonnulae
6.7 QualityofIngredients
Calciumhydroxide
6.7.1 All ingredients used shall be clean, ofgood
Sodiumcitrate Limited by good
Potassiumcitrate manufacturing practice quality,safeandsuitableforingestionbyinfants.
L(+)Lacticacid } in all types of infimt 6.7.2 Thevitaminsandmineralsshallbeoffoodgrade.
Citricacid formulae
Iron salts should be such so as to ensure high bio
availabilityofiron. The source of mineralsalts and
6.3 Theflavouroftheproduct indry conditionorof
the reconstitutedfeed shall be fresh and sweet.The vitamincompoundsmaybeusedfrom:
materialshallnothaveanyrancidtasteormustyodour
a) Minerals
(seeIS10641).
1) Calcium(Ca)- Calciumcarbonate,calcium
6.4 The scorched particles in the product shall not
chloride,calciumcitrate,calciumphosphate
exceed 15mg(equivalentto Disc B)whentestedas
monobasic, calcium phosphate dibasic,
perthemethodgiveninIS 13500.
calciumphosphatetribasic;
6.S InTypeII Infantmilksubstitutes,vegetableoils
2) Phosphorous (P) - Calcium phosphate
addedshallberich inpolyunsaturatedfattyacids. It
monobasic, calcium phosphate dibasic,
shallalsocontainaminimumlinoleate(linoleicacidin
calcium phosphate tribasic, magnesium
formofglycerides)contentof1.398gper100gofthe
phosphate dibasic, potassium phosphate
productwhen determined as per the method givenin dibasic;
AnnexAofIS6387.Theproductshallalsocontaina
3) Chloride (CI) - Calciumchloride,choline
minimumof0.70illofvitaminEper 100kcal,when
chloride, magnesium chloride, manganese
determinedasperthemethodgiveninIS7235.
chloride, sodium chloride, sodiumchloride
6.6 Type II Infant milk substitutes may contain in iodized;
additiontothevitaminandmineralslistedunder3.2, 4) Iron(Fe) - Ferrouscitrate, ferrouslactate,
other nutrients when required in order to provide ferroussulphate,ferricpyrophosphate;
nutrientsordinarilyfoundinhumanmilksuchas:
S) Magnesium (Mg) ..:.- Magnesium chloride,
a) Carotenes :Notlessthan 0.25mgll magnesium oxide, magnesium phosphate
b) Fluorine :Notlessthan0.107mgll dibasic;
c) Aminoacids :Notlessthan9mgll(only 6) Sodium(Na)- Sodiumbicarbonate,sodium
L forms of aminoacids chloride, sodium chloride iodized, sodium
shouldbeused) citrate,sodiumphosphatemonobasic;
d) Non-protein :Notlessthan 173mgll 7) Potassium (K) - Potassium phosphate
nitrogen dibasic;
e) Nucleotides :Notlessthan11.7ntg/l 8) Copper (Cu) - Cupric citrate, cupric
sulphate;
f) Carnitine :Not lessthan ]1.27J.1g/l
g) Lactalbumin :Notlessthan 1.4gil 9) Iodine(I)- Potassiumiodide,sodiumiodide;
b) Lactoferrin :Notlessthan0.27gil 10) Zinc(Zn)~Zincsulphate;and
j) Lysozyme :NotJessthan0.8gil 11) Manganese (Mo) - Manganese chloride,
manganesesulphate.
k) Fucose :Notlessthan 1.3gil
m) Glucosamine :Not lessthan0.7gil b) Vitamins
n) Inositol :Notlessthan0.39gil 1) VitaminA- Retinylacetateretinylpalmitate,
t
p) Citricacid :Not lessthanO.3S gil retinylpropionate
IS14433:2007
2) ProvitaminA- Beta-carotene; 6.9.5 SalmonellaandShigella
3) Vitamin D- Vitamin O2- Ergocalciferol, Salmonella and Shigellashall beabsent per 25g of
Vitamin OJ Cholecalciferol,
theproductwhentested asperthemethodprescribed
cholecalciferol-cholesterol;
inIS5887(Part3)and IS5887(Part7)respectively.
4) Vitamin E - d-alpha-tocopherol, dl-alpha (set Note).
tocopherol, d-alpha-tocopheryl acetate,
dl-alpha-tocopheryl acetate, d-alpha NOTE- TherequirementsforSalmon~llaandShig~/lashall
be testedina laboratorysituatedawayfromtheproduction
tocopheryl succinate, dl-alpha-tocopheryl area.
succinate;
S) Thiamin (Vitamin B.) - Thiaminchloride 6.9.6 YeastandMouldCount
hydrochloride,thiaminmononitrate; Yeastandmouldshallbeabsentper0.1goftheproduct
6) Riboflavin (Vitamin 82) - Riboflavin, whentestedasperIS5403.
Riboflavin5' - phosphatesodium;
6.10 The Infantmilksubstitutesshallalsoconformto
7) Niacin - Nicotinamide,nicotinicacid;
requirementsgiveninTable1.
8) Vitamin 86- Pyridoxinehydrochloride; 6.10.1 Thelowbirthweightinfantmilksubstituteshall
9) Biotin (Vitamin H) - d-biotin;
meettherequirementsprescribedbelowinadditionto
10) Folacin - Folicacid;
the requirements prescribed for Type II Infant milk
11) Pantothenic acid - Calcium pantothenate, substituteunder6 andTable I.
panthenol;
a) Proteincontentshallbe2.25g1tOO kcaVJ to
12) Vitamin B12 Cyanocobalamin, 2.75g/lOOkcal/J,whendeterminedasperthe
hydroxycobalamin;
methodprescribedinIS7219.
13) Vitamin K- Phytylmenaquinone;
b) Mineralcontent shallnot be lessthan 0.5 g/
14) VitaminC- Ascorbicacid,sodiumascorbate,
100kcal.TheCalcium:Phosphorusratioshall
calciumascorbate, ascorbyl-6-palmitate;
be 2:1whendetermined as per themethods
15) Choline - Choline bitartrate, choline prescribed in IS 5949 and IS 12756
chloride; respectively.Sodium,PotassiumandChloride
16) Inositol; and combined together shall not be lessthan40
17) Selenium- Sodiumselenite. milliequivalentperlitrewhendetermined as
per the methods prescribed inIS )2760and
6.8 HygienicCoadltions
IS11763.
Thematerialshallbemanufacturedandpackedunder c) Whey:Caseinratioshallbe60:40.Essential
hygienicconditions(seeIS2491). amino acids should includetaurine,cystine,
tyrosineandhistidine.
6.9 Bacteriological Requirements
NOTES
6.9.1 BacterialCount 1 IkJ..0.238 846 kcalorIkcal=4.1868kJ.
2 Fortheconversionofthevaluesofrequirementsof
Thebacterialcolonycountpergramoftheproductshall
thecharacteristicsfrompercentbymass(per100g)to
notbemorethan 10000whendeterminedaccording thevalueper100kcal,thetotalkcalcontentofthefood
tothemethodprescribedinIS5402. shall be based upon the values of 4 kcallg of
carbohydratesandpergofproteins;and9kcal/goffal.
6.9.2 Coliform Count Carbohydratesmaybe determinedas perthemethod
prescribedunderAnnexCofIS16S6.
Coliform bacteria shall be absent per 0.1 g ofthe
3 TheCommittee,isintheprocessofidentifyingthe
product when determined according to the method methodoftestfordeterminationofwhey:caseinratio.
prescribedinIS5401. Till such time the method of test is identified, the
manufactureswouldberequiredto maintainrecords
6.9.3 Escherichtacoli showingcompliancewiththestatedrequirement.
Escherichiacolishallbeabsentper0.1goftheproduct 6.10.2 Lactosefreeinfantmilksubstitute,lactoseand
when testedasperthe methodprescribed inIS 5887 sucrose free infant milk substitute and sucrose free
(part 1). infantmilksubstituteshallalsomeettherequirements
prescribed below in addition to the requirements
6.9.4 Staphylococcusaureus
prescribed for Type II Infantmilk substituteunder6
Staphylococcusaureusshallbeabsentper0.1gofthe andTable1,providedthatinthesethreeproductsedible
product.when tested as per the methodprescribedin vegetable oil maybe used in place of milk fat and
IS5887(part2). lecithinmaybeusedasemulsifier:
3