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CFRCodeofFederalRegulationsTitle21

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CFRCodeofFederalRegulationsTitle21
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[CodeofFederalRegulations]
[Title21,Volume3]
[RevisedasofApril1,2014]
[CITE:21CFR173.310]

TITLE21FOODANDDRUGS
CHAPTERIFOODANDDRUGADMINISTRATION
DEPARTMENTOFHEALTHANDHUMANSERVICES
SUBCHAPTERBFOODFORHUMANCONSUMPTION(CONTINUED)
PART173SECONDARYDIRECTFOODADDITIVESPERMITTEDINFOODFORHUMAN
CONSUMPTION
SubpartDSpecificUsageAdditives
Sec.173.310Boilerwateradditives.
Boilerwateradditivesmaybesafelyusedinthepreparationofsteam
thatwillcontactfood,underthefollowingconditions:
(a)Theamountofadditiveisnotinexcessofthatrequiredforits
functionalpurpose,andtheamountofsteamincontactwithfooddoes
notexceedthatrequiredtoproducetheintendedeffectinoronthe
food.
(b)Thecompoundsarepreparedfromsubstancesidentifiedin
paragraphs(c)and(d)ofthissection,andaresubjecttothe
limitations,ifany,prescribed:
(c)Listofsubstances:
Substances
Acrylamidesodiumacrylateresin

Limitations
Containsnotmorethan0.05percent
byweightofacrylamidemonomer.

Acrylicacid/2acrylamido2
methylpropanesulfonicacid
copolymerhavingaminimumweight
averagemolecularweightof9,900
Totalnottoexceed20partsper
andaminimumnumberaverage
million(active)inboiler
molecularweightof5,700as
feedwater.
determinedbyamethodentitled
"DeterminationofWeightAverage
andNumberAverageMolecular
Weightof60/40AA/AMPS"
Ammoniumalginate
Cobaltsulfate(ascatalyst)
1hydroxyethylidene1,1
diphosphonicacid(CASReg.No.
2809214)anditssodiumand
potassiumsalts
Lignosulfonicacid
Monobutylethersofpolyethylene
polypropyleneglycolproducedby
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randomcondensationofa1:1
mixturebyweightofethylene
oxideandpropyleneoxidewith
butanol
Poly(acrylicacidco
hypophosphite),sodiumsalt(CAS
Reg.No.71050629),produced
froma4:1toa16:1mixtureby
weightofacrylicacidandsodium
hypophosphite
Polyethyleneglycol
Polymaleicacid[CASReg.No.
26099092],and/oritssodium
salt.[CASReg.No.30915618or
CASReg.No.70247904]
Polyoxypropyleneglycol
Potassiumcarbonate
Potassiumtripolyphosphate
Sodiumacetate
Sodiumalginate
Sodiumaluminate
Sodiumcarbonate

Sodiumcarboxymethylcellulose

Sodiumglucoheptonate
Sodiumhexametaphosphate
Sodiumhumate
Sodiumhydroxide
Sodiumlignosulfonate
Sodiummetabisulfite
Sodiummetasilicate
Sodiumnitrate
Sodiumphosphate(mono,di,
tri)
Sodiumpolyacrylate
Sodiumpolymethacrylate
Sodiumsilicate
Sodiumsulfate
Sodiumsulfite(neutralor
alkaline)
Sodiumtripolyphosphate
Sorbitolanhydrideesters:A
mixtureconsistingofsorbitan
monostearateasdefinedin172.
842ofthischapterpolysorbate

CFRCodeofFederalRegulationsTitle21

Minimummol.wt.1,500.

Totalnottoexceed1.5partsper
millioninboilerfeedwater.
Copolymercontainsnotmorethan0.5
percentbyweightofacrylicacid
monomer(dryweightbasis).
Asdefinedin172.820ofthis
chapter.
Totalnottoexceed1partper
millioninboilerfeedwater
(calculatedastheacid).
Minimummol.wt.1,000.

Containsnotlessthan95percent
sodiumcarboxymethylcelluloseona
dryweightbasis,withmaximum
substitutionof0.9
carboxymethylcellulosegroupsper
anhydroglucoseunit,andwitha
minimumviscosityof15centipoises
for2percentbyweightaqueous
solutionat25deg.Cbythe
"ViscosityofCelluloseGum"method
prescribedintheFoodChemicals
Codex,pp.11281129.
Lessthan1partpermillioncyanide
inthesodiumglucoheptonate.

Themixtureisusedasan

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60((polyoxyethylene(20)
sorbitanmonostearate))as
definedin172.836ofthis
chapterandpolysorbate20
((polyoxyethylene(20)sorbitan
monolaurate)),meetingthe
specificationsoftheFood
ChemicalsCodex,pp.825827.

CFRCodeofFederalRegulationsTitle21

anticorrosiveagentinsteamboiler
distributionsystems,witheach
componentnottoexceed15
milligramsperkilograminthe
steam.

Tannin(includingquebracho
extract)
TetrasodiumEDTA
Tetrasodiumpyrophosphate
(d)Substancesusedaloneorincombinationwithsubstancesin
paragraph(c)ofthissection:
Substances
Limitations
Nottoexceed10partspermillioninsteam,and
Cyclohexylamine
excludinguseofsuchsteamincontactwithmilk
andmilkproducts.
Nottoexceed15partspermillioninsteam,and
Diethylaminoethanol excludinguseofsuchsteamincontactwithmilk
andmilkproducts.
Hydrazine
Zeroinsteam.
Nottoexceed10partspermillioninsteam,and
Morpholine
excludinguseofsuchsteamincontactwithmilk
andmilkproducts.
Nottoexceed3partspermillioninsteam,and
Octadecylamine
excludinguseofsuchsteamincontactwithmilk
andmilkproducts.
Nottoexceed5partspermillioninboiler
Trisodium
feedwaternottobeusedwheresteamwillbein
nitrilotriacetate
contactwithmilkandmilkproducts.
(e)Toassuresafeuseoftheadditive,inadditiontotheother
informationrequiredbytheAct,thelabelorlabelingshallbear:
(1)Thecommonorchemicalnameornamesoftheadditiveoradditives.
(2)Adequatedirectionsforusetoassurecompliancewithallthe
provisionsofthissection.
(f)Thestandardsrequiredinthissectionareincorporatedby
referenceintothissectionwiththeapprovaloftheDirectorofthe
FederalRegisterunder5U.S.C.552(a)and1CFRpart51.Copiesmay
beexaminedattheFoodandDrugAdministration'sMainLibrary,10903
NewHampshireAve.,Bldg.2,ThirdFloor,SilverSpring,MD20993,
3017962039,orattheNationalArchivesandRecordsAdministration
(NARA).ForinformationontheavailabilityofthismaterialatNARA,
call2027416030orgoto:http://www.archives.gov/federal
register/cfr/ibrlocations.html.
(1)FDAMainLibrary,10903NewHampshireAve.,SilverSpring,MD
20993:
(i)"DeterminationofWeightAverageandNumberAverageMolecular
Weightof60/40AA/AMPS"(October23,1987).
(ii)[Reserved]
(2)UnitedStatesPharmacopeialConvention,12601TwinbrookPkwy.,
Rockville,MD20852(Internetaddresshttp://www.usp.org):
(i)FoodChemicalsCodex,7thed.(2010),pp.11281129.
(ii)FoodChemicalsCodex,7thed.(2010),pp.825827.
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CFRCodeofFederalRegulationsTitle21

[42FR14526,Mar.15,1977,asamendedat45FR73922,Nov.7,1980
45FR85726,Dec.30,198048FR7439,Feb.22,198349FR5748,
Feb.15,198449FR10106,Mar.19,198450FR49536,Dec.3,1985
53FR15199,Apr.28,198854FR31012,July26,198955FR12172,
Apr.2,199061FR14245,Apr.1,199664FR1759,Jan.12,199964
FR29227,June1,199978FR71466,Nov.29,2013]
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