CFR - Code of Federal Regulations Title 21-2

4/8/2015
CFRCodeofFederalRegulationsTitle21
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Help6|MoreAbout21CFR7
[CodeofFederalRegulations]
[Title21,Volume3]
[RevisedasofApril1,2014]
[CITE:21CFR176.170]
TITLE21FOODANDDRUGS
CHAPTERIFOODANDDRUGADMINISTRATION
DEPARTMENTOFHEALTHANDHUMANSERVICES
SUBCHAPTERBFOODFORHUMANCONSUMPTION(CONTINUED)
PART176INDIRECTFOODADDITIVES:PAPERANDPAPERBOARDCOMPONENTS
SubpartBSubstancesforUseOnlyasComponentsofPaperandPaperboard
Sec.176.170Componentsofpaperandpaperboardincontactwithaqueousandfattyfoods.
Substancesidentifiedinthissectionmaybesafelyusedascomponentsoftheuncoatedorcoatedfoodcontact
surfaceofpaperandpaperboardintendedforuseinproducing,manufacturing,packaging,processing,preparing,
treating,packing,transporting,orholdingaqueousandfattyfoods,subjecttotheprovisionsofthissection.
ComponentsofpaperandpaperboardincontactwithdryfoodofthetypeidentifiedunderTypeVIIIoftable1in
paragraph(c)ofthissectionaresubjecttotheprovisionsof176.180.
(a)Substancesidentifiedinparagraph(a)(1)through(5)ofthissectionmaybeusedascomponentsofthefood
contactsurfaceofpaperandpaperboard.Paperandpaperboardproductsshallbeexemptedfromcompliancewiththe
extractiveslimitationsprescribedinparagraph(c)ofthissection:Provided,Thatthecomponentsofthefood
contactsurfaceconsistentirelyofoneormoreofthesubstancesidentifiedinthisparagraph:Andprovided
further,Thatifthepaperorpaperboardwhenextractedundertheconditionsprescribedinparagraph(c)ofthis
sectionexceedsthelimitationsonextractivescontainedinparagraph(c)ofthissection,informationshallbe
availablefrommanufacturingrecordsfromwhichitispossibletodeterminethatonlysubstancesidentifiedinthis
paragraph(a)arepresentinthefoodcontactsurfaceofsuchpaperorpaperboard.
(1)Substancesgenerallyrecognizedassafeinfood.
(2)Substancesgenerallyrecognizedassafefortheirintendeduseinpaperandpaperboardproductsusedinfood
packaging.
(3)Substancesusedinaccordancewithapriorsanctionorapproval.
(4)Substancesthatbyregulationinparts170through189ofthischaptermaybesafelyusedwithoutextractives
limitationsascomponentsoftheuncoatedorcoatedfoodcontactsurfaceofpaperandpaperboardincontactwith
aqueousorfattyfood,subjecttotheprovisionsofsuchregulation.
(5)Substancesidentifiedinthisparagraph,asfollows:
ListofSubstances
Acetylperoxide
Acrylamidemethacrylicacidmaleicanhydridecopolymerscontainingnotmorethan0.2
percentofresidualacrylamidemonomerandhavinganaveragenitrogencontentof14.9
percentsuchthata1percentbyweightaqueoussolutionhasaminimumviscosityof600
centipoisesat75deg.F,asdeterminedbyLVGseriesBrookfieldviscometer(or
equivalent)usingaNo.2spindleat30r.p.m
Limitations
Foruseonlyas
polymerizationcatalyst.
Foruseonlyasa
retentionaidemployed
priortothesheetforming
operationinthe
manufactureofpaperand
paperboardinsuchan
amountthatthefinished
paperandpaperboardwill
containtheadditiveata
levelnotinexcessof
0.05percentbyweightof
dryfibersinthefinished
paperandpaperboard.
Foruseonlyasa
retentionaidand
Acrylamide[beta]methacrylyloxyethyltrimethylammoniummethylsulfatecopolymerresins
flocculantemployedprior
containingnotmorethan10molarpercentof[beta]methacrylyloxyethyltrimethylammonium tothesheetforming
methylsulfateandcontaininglessthan0.2%ofresidualacrylamidemonomer
operationinthe
paperboard.
Acrylicacid,sodiumsaltcopolymerwithpolyethyleneglycolallylether(CASReg.No.
Foruseonlyinpapermill
86830151)
boilers.
Foruseonlyasascale
inhibitorpriortothe
sheetformingoperationin
Acrylicacidcopolymerwith2acrylamido2methylpropanesulfonicacid(CASReg.No.
themanufactureofpaper
40623754)and/oritsammonium/alkalimetalmixedsalts.Thecopolymerisproducedby
andpaperboardandusedat
polymerizationofacrylicacidand2acrylamido2methylpropanesulfonicacidinaweight
alevelnottoexceed1.0
ratioof60/40,suchthata28percentbyweightaqueoussolutionofthepolymerhasa
kilogram(2.2pounds)of
viscosityof75150centipoisesat25deg.CasdeterminedbyLVseriesBrookfield
copolymerper907
viscometer(orequivalent)usingaNo.2spindleat60r.p.m
kilograms(1ton)ofdry
paperandpaperboard
fibers.
Acrylonitrilepolymer,reactionproductwithethylenediaminesulfatehavinganitrogen
Foruseonlyasasize
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=176.170
1/30
4/8/2015
contentof22.525.0percent(Kjeldahldrybasis)andcontainingnomorethan0.075
percentmonomerasethylenediamine.Thefinishedresinina24percentbyweightaqueous
solutionhasaviscosityof1,0002,000centipoisesat25deg.CasdeterminedbyLVT
seriesBrookfieldviscometerusingaNo.4spindleat50r.p.m.(orbyotherequivalent
method)
promoterandretentionaid
atalevelnottoexceed
thedrypaperand
paperboard.
1.Foruseonlyasa
sizingmaterialapplied
afterthesheetforming
operationinthe
paperboardinsuchamount
thatthepaperand
paperboardwillcontain
theadditiveatalevel
notinexcessof0.25
percentbyweightofthe
Acrylonitrilepolymerwithstyrene,reactionproductwithethylenediamineacetate,having
drypaperandpaperboard.
anitrogencontentof7.48.3percent(Kjeldahldrybasis)andcontainingnomorethan
2.Foruseonlyasa
0.25percentmonomerasethylenediamine
sizingmaterialapplied
operationinthe
thatthepaperand
paperboardwillcontain
theadditiveatalevel
notinexcessof1.0
Foruseonlyunderthe
followingconditions:1.
Incoatingsforpaperand
paperboardwithfoodof
TypesI,II,IVB,and
VIIBdescribedintable1
ofparagraph(c)ofthis
sectionunderconditions
ofuseE,F,andG
describedintable2of
1Alkenylolefins,containingnotlessthan72percentofC30andhigherolefins
paragraph(c)ofthis
section.2.Incoatings
forpaperandpaperboard
withfoodofTypeVIII
describedintableIof
paragraph(c)ofthis
ofuseAthroughH
describedintable2of
paragraph(c)ofthis
section.
(2Alkenyl)succinicanhydridesmixture,inwhichthealkenylgroupsarederivedfrom
olefinswhichcontainnotlessthan95percentofC15C21groups
Alkyl(C12C20)methacrylatemethacrylicacidcopolymers(CASReg.No.27401065)
tertAlkyl(C8C16)mercaptans
Foruseonlyasasizing
agentemployedpriorto
thesheetforming
operationinthe
paperboardandlimitedto
useatalevelnotto
exceed1percentbyweight
ofthefinisheddrypaper
andpaperboardfibers.
Foruseonlyas
stabilizersemployedprior
tothesheetforming
operationinthe
paperboard.
Foruseonlyas
polymerizationcontrol
agent.
Aluminumacetate
2Amino2methyl1propanol(CASReg.No.124685)
Foruseasadispersant
forpigmentsuspensionat
alevelnottoexceed0.25
percentbyweightof
pigment.Thesuspensionis
usedasacomponentof
coatingsforpaperand
paperboardunder
conditionsofuse
describedinparagraph(c)
ofthissection,table2,
conditionsofuseE
throughG.
Foruseonlyasanoiland
waterrepellantatalevel
2/30
4/8/2015
nottoexceed0.17pound
(0.09poundoffluorine)
per1,000squarefeetof
treatedpaperor
paperboardofasheet
basisweightof100pounds
orlessper3,000square
feetofpaperor
paperboard,andatalevel
nottoexceed0.5pound
treatedpaperor
paperboardhavingasheet
basisweightgreaterthan
100lb.per3,000square
feetasdeterminedby
Ammoniumbis(Nethyl2perfluoroalkylsulfonamidoethyl)phosphates,containingnotmore
analysisfortotal
than15%ammoniummono(Nethyl2perfluoroalkylsulfonamidoethyl)phosphates,wherethe fluorineinthetreated
alkylgroupismorethan95%C8andthesaltshaveafluorinecontentof50.2%to52.8%as paperorpaperboard
determinedonasolidsbasis
withoutcorrectionforany
fluorinethatmightbe
presentintheuntreated
paperorpaperboard,when
suchpaperorpaperboard
isusedasfollows:1.In
contact,underconditions
ofuseC,D,E,F,G,orH
describedintable2of
paragraph(c)ofthis
section,withnonalcoholic
food.2.Incontactwith
bakeryproductsofType
VII,VIII,andIX
describedintableIof
paragraph(c)ofthis
sectionundergood
manufacturingpracticesof
commercialand
institutionalbaking.
Ammoniumpersulfate
Ammoniumthiosulfate
Foruseonlyasan
insolubilizerforbinders
usedincoatingsforpaper
andpaperboard,and
Ammoniumzirconiumcarbonate(CASReg.No.32535845)anditstartaricacidadduct
limitedtouseatalevel
nottoexceed2.5percent
byweightofcoating
solids.
Foruseasinsolubilizers
withproteinbindersin
Ammoniumzirconiumcitrate(CASReg.No.149564625),ammoniumzirconiumlactatecitrate coatingsforpaperand
(CASReg.No.149564647),ammoniumzirconiumlactate(CASReg.No.149564636)
paperboard,atalevelnot
toexceed1.4percentby
weightofcoatingsolids.
Anionicpolyurethane,producedbyreactingthepreliminaryadductformedfromthereaction Foruseonlyasasurface
ofglycerylmonostearateand2,4toluenediisocyanatewithnotmorethan10molepercentN sizingagentatalevel
methyldiethanolamineandnotlessthan90molepercentdimethylolpropionicacid.Thefinal nottoexceed0.1percent
productisa15to20percentbyweightaqueoussolution,havingaBrookfieldviscosityof byweightofdrypaperand
paperboard.
25to100centipoisesat24deg.C(75deg.F)
Foruseonlyasapulping
aidinthealkaline
pulpingoflignocellulosic
9,10Anthraquinone(ChemicalAbstractsServiceRegistryNo.84651)whichhasapurityof
materialatlevelsnotto
notlessthan98percent
exceed0.1percentby
weightoftheraw
lignocellulosicmaterial.
Aromaticpetroleumhydrocarbonresin,hydrogenated(CASReg.No.88526470),producedby
thecatalyticpolymerizationofaromaticsubstitutedolefinsfromlowboilingdistillates
ofcrackedpetroleumstockswithaboilingpointnogreaterthan220deg.C(428deg.F),
Foruseonlyasmodifiers
andthesubsequentcatalyticreductionoftheresultingaromaticpetroleumhydrocarbon
resin.Theresinmeetsthefollowingspecifications:softeningpoint85deg.C(185deg. inwaxpolymerblend
F)minimum,asdeterminedbyASTMMethodE2867(Reapproved1982),"StandardTestMethod coatingsforpaperand
forSofteningPointbyRingandBallApparatus,"andanilinepoint70deg.C(158deg.F) paperboardatalevelnot
minimum,asdeterminedbyASTMMethodD61182,"StandardTestMethodsforAnilinePoint toexceed50weight
percentofthecoating
andMixedAnilinePointofPetroleumProductsandHydrocarbonSolvents,"whichare
incorporatedbyreferenceinaccordancewith5U.S.C.552(a)and1CFRpart51.Copiesmay solidsunderconditionsof
beobtainedfromtheAmericanSocietyforTestingandMaterials,100BarrHarborDr.,West useE,F,andGidentified
Conshohocken,Philadelphia,PA194282959,ormaybeexaminedattheNationalArchivesand intable2ofparagraph
(c)ofthissection.
RecordsAdministration(NARA).Forinformationontheavailabilityofthismaterialat
NARA,call2027416030,orgoto:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
Azobisisobutyronitrile
Foruseonlyas
3/30
4/8/2015
1,2Benzisothiazolin3one(CASRegistryNo.2634335)
Foruseonlyasa
preservativeinpaper
coatingcompositionsand
nottoexceed0.01mg/in2
(0.0016mg/cm2)ofthe
finishedpaperand
paperboard.
Benzoylperoxide
Do.
Foruseonlyasan
adjuvanttocontrolpulp
absorbencyandpitch
N,NBis(2hydroxyethyl)alkyl(C12C18)amide
contentinthemanufacture
ofpaperandpaperboard
operation.
Foruseonlyunderthe
Asawaterrepellant
employedpriortothe
andpaperboardinsuch
levelnotinexcessof1.6
finisheddrypaperand
paperboardfibers.2.The
finishedpaperand
paperboardwillbeusedin
contactwithnonalcoholic
foodsonly.3.Asawater
Bis(methoxymethyl)tetrakis[(octadecyloxy)methyl]melamineresinshavinga5.86.5percent repellantemployedafter
nitrogencontent(CASReg.No.68412271)
thesheetforming
operationinthe
thatthefinishedpaper
andpaperboardwill
levelnottoexceed1.6
finisheddrypaperand
paperboardfibers.The
finishedpaperand
paperboardwillbeused
onlyincontactwithfood
ofTypesI,II,IVB,VI,
VIIB,andVIIIdescribed
intable1ofparagraph
(c)ofthissection.
2Bromo2nitro1,3propanediol(CASReg.No.52517)
Butanedioicacid,sulfo1,4di(C9C11alkyl)ester,ammoniumsalt(alsoknownas
butanedioicacid,sulfo1,4diisodecylester,ammoniumsalt[CASReg.No.144093889]).
tertButylhydroperoxide
tertButylperoxide
Calciumisostearate
Foruseonlyasan
antimicrobial/preservative
infillers,pigment
slurries,starchsizing
solutions,andlatex
coatingsatlevelsnotto
exceed0.01percentby
weightofthose
components.
Foruseasasurface
activeagentinpackage
coatinginksatlevelsnot
toexceed3percentby
weightofthecoatingink.
Foruseonlyas
Do.
Foruseonlywithndecyl
alcoholasastabilizing
materialforaqueous
calciumstearate
dispersionsintendedfor
useascomponentsof
coatingsforpaperand
paperboard.
Carrageenanandsaltsofcarrageenanasdescribedin172.620and172.626ofthischapter
Castoroil,hydrogenated
Castoroil,sulfated,ammonium,potassium,orsodiumsalt
Cellulose,regenerated
Foruseonlyas
4/30
4/8/2015
Chloracetamide
Cobaltousacetate
Cumenehydroperoxide
Cyanoguanidine
nDecylalcohol
polymerizationcontrol
agent.
Foruseonlyas
Do.
Foruseonly:1.Asa
modifierforaminoresins.
2.Asafluidizingagent
instarchandprotein
coatingsforpaperand
paperboard.
Foruseonlywithcalcium
isostearateasa
stabilizingmaterialfor
aqueouscalciumstearate
dispersionsintendedfor
useascomponentsof
coatingsforpaperand
paperboard.
Foruseonlyasawet
strengthagentemployed
operationinthe
Dialdehydeguargum
paperboardandusedata
levelnottoexceed1%by
weightofthefinisheddry
paperandpaperboard
fibers.
Dialdehydelocustbeangum
Do.
Foruseasasizingagent
Dialkyl(C16C18)carbamoylchloride(CASReg.No.41319544)manufacturedbythereaction atalevelnottoexceed
ofsecondaryaminesderivedfromfattyacidsofanimalorvegetablesourceswithphosgene 0.2percentbyweightof
thedryfiber.
Foruseonlyasa
Diallyldimethylammoniumchloridepolymerwithacrylamideandpotassiumacrylate,produced
retentionand/ordrainage
bycopolymerizingeither(1)diallyldimethylammoniumchlorideandacrylamideinaweight
aidemployedpriortothe
ratioof50/50,with4.4percentoftheacrylamidesubsequentlyhydrolyzedtopotassium
sheetformingoperations
acrylateor(2)polymerizeddiallyldimethylammoniumchloride,acrylamideandpotassium
inthemanufactureof
acrylate(asacrylicacid)inaweightratioof50/47.8/2.2,respectively,sothatthe
paperandpaperboardand
finishedresinina1percentbyweightaqueoussolution(activepolymer)hasaviscosity
ofmorethan22centipoisesat22deg.C(72deg.F)asdeterminedbyLVFseries,
BrookfieldViscometerusingNo.1spindleat60RPM(orbyotherequivalentmethod)(CAS
byweightofthefinished
Reg.No.25136758)
paperandpaperboard.
Foruseonlyasadrainage
and/orretentionaid
Diallyldimethylammoniumchloridewithacrylamide(CASReg.No.26590056).Thecopolymer employedpriortothe
isproducedbycopolymerizingdiallyldimethylammoniumchloridewithacrylamideinaweight sheetformingoperationin
ratioof5050sothatthefinishedresinina1percentbyweightaqueoussolution
(activepolymer)hasaviscosityofmorethan22centipoisesat22deg.C(71.6deg.F), andpaperboardandlimited
asdeterminedbyLVFseriesBrookfieldviscometerusingaNo.1spindleat60r.p.m.(or touseatalevelnotto
byotherequivalentmethod)
exceed0.05percentby
weightofthefinished
paperandpaperboard.
Diallyldiethylammoniumchloridepolymerwithacrylamide,anddiallyldimethylammonium
chloride,producedbycopolymerizingacrylamide,diallyldiethylammoniumchloride,and
diallyldimethylammoniumchloride,respectively,inthefollowingweightratiosandhaving
viscositiesdeterminedat22deg.C,byLVFseriesBrookfieldviscometerusingaNo.1
spindleat60r.p.m.(orbyotherequivalentmethod),asfollows:
Foruseonlyasa
operationinthe
1.Weightratio:502.547.5.Thefinishedresinina1percentbyweightaqueous
solutionhasaminimumviscosityof22centipoises
useatalevelnotto
exceed0.05percentby
weightofthefinished
paperandpaperboard.
and/orretentionaid
employedpriortothe
2.Weightratio:252.572.5.Thefinishedresinina0.20percentbyweightaqueous
andpaperboardandlimited
touseatalevelnotto
exceed0.075percentby
weightofthefinished
paperandpaperboard.
3.Weightratio:802.517.5.Thefinishedresinina0.30percentbyweightaqueous
and/orretentionaid
employedpriortothe
5/30
4/8/2015
touseatalevelnotto
weightofthefinished
paperandpaperboard.
Foruseonlyasa
Diallyldiethylammoniumchloridepolymerwithacrylamide,potassiumacrylate,and
diallyldimethylammoniumchloride.Thepolymerisproducedbycopolymerizingeither:(1)
acrylamide,diallyldiethylammoniumchloride,anddiallyldimethylammoniumchlorideina
operationinthe
weightratioof502.547.5,respectively,with4.4percentoftheacrylamidesubsequently
hydrolyzedtopotassiumacrylate,or(2)acrylamide,potassiumacrylate(asacrylicacid),
diallyldiethylammoniumchloride,anddiallyldimethylammoniumchlorideinaweightratioof
useatalevelnotto
47.82.22.547.5,sothatthefinishedresinina1percentbyweightaqueoussolution
exceed0.05percentby
hasaminimumviscosityof22centipoisesat22deg.C,asdeterminedbyLVFseries
weightofthefinished
BrookfieldviscometerusingaNo.1spindleat60r.p.m.(orbyotherequivalentmethod)
paperandpaperboard.
Foruseonlyasadryand
wetstrengthagent
employedpriortothe
Diallyldimethylammoniumchloridepolymerwithacrylamide,reactionproductwithglyoxal,
producedbycopolymerizingnotlessthan90weightpercentofacrylamideandnotmorethan
andpaperboardinsuchan
10weightpercentofdiallyldimethylammoniumchloride,whichisthencrosslinkedwithnot
morethan30weightpercentofglyoxal,suchthata10percentaqueoussolutionhasa
minimumviscosityof25centipoisesat25deg.CasdeterminedbyBrookfieldviscometer
ModelRVF,usingaNo.1spindleat100r.p.m
levelnotinexcessof2
dryfibersinthefinished
paperandpaperboard.
Foruseasapreservative
atalevelnottoexceed
100partspermillionin
coatingformulationsand
2,2Dibromo3nitrilopropionamide(CASReg.No.10222012).
incomponentslurriesand
emulsions,usedinthe
productionofpaperand
paperboardandcoatings
forpaperandpaperboard.
Foruseonlyasan
antioxidantforfatty
basedcoatingadjuvants
2,5Ditertbutylhydroquinone
provideditisusedata
levelnottoexceed0.005%
byweightofcoating
solids.
Foruseonly:1.Asan
absorbencyandpitch
Diethanolamine
operation.2.Inpapermill
boilers.
nottoexceed0.17pound
treatedpaperor
paperboard,asdetermined
byanalysisfortotal
fluorineinthetreated
paperorpaperboard
Diethanolaminesaltsofmonoandbis(1H,1H,2H,2Hperfluoroalkyl)phosphateswherethe
alkylgroupisevennumberedintherangeC8C18andthesaltshaveafluorinecontentof
fluorinewhichmightbe
52.4%to54.4%asdeterminedonasolidsbasis
isusedincontactwith
nonalcoholicfoodsunder
theconditionsofuse
conditionsofuse(B)
through(H).
Diethyl(2hydroxyethyl)methylammoniummethylsulfate,acrylate,polymerwithacrylamide,
chemicalabstractserviceregistryNo.[26796758]having9095molepct.acrylamide,a
nitrogencontentofnotmorethan19.7pct.(Kjeldahl,drybasis),andaresidual
acrylamidemonomercontentofnotmorethan0.1pct.Thefinishedpolymerina1pct.by
weightaqueoussolutionhasaminimumviscosityof900centipoisesat25deg.Cas
determinedbyLVTseriesBrookfieldviscometerusingaNo.2spindleat12r.p.m.(orby
equivalentmethod)
Foruseonlyasa
retentionaidanddrainage
aidemployedpriortothe
andpaperboardatalevel
nottoexceed0.15pct.by
weightoffinisheddry
paperandpaperboard
fibers.
Foruseonlyasamodifier
6/30
4/8/2015
Diethylenetriamine
foraminoresins.
Foruseonlyasan
absorbencyandpitch
N,NDiisopropanolamideoftallowfattyacids
operation.
Foruseonly:1.Asa
beforethesheetforming
operationinthe
Dimethylamineepichlorohydrincopolymerinwhichnotmorethan5molepercentof
dimethylaminemaybereplacedbyanequimolaramountofethylenediamineandinwhichthe
ratiooftotalaminetoepichlorohydrindoesnotexceed1:1.Thenitrogencontentofthe
useatalevelnotto
copolymershallbe9.4to10.8weightpercentonadrybasisanda10percentbyweight
aqueoussolutionofthefinalproducthasaminimumviscosityof5.0centipoisesat25
ofthefinishedpaperand
deg.C,asdeterminedbyLVTseriesBrookfieldviscometerusingaNo.1spindleat60
paperboard.2.Atthesize
r.p.m.(orbyotherequivalentmethod)
pressatalevelnotto
weightofthefinished
paperandpaperboard.
Foruseonlyasadry
operationinthe
N[(Dimethylamino)methyl]acrylamidepolymerwithacrylamideandstyrenehavinganitrogen manufactureofpaperand
contentofnotmorethan16.9percentandaresidualacrylamidemonomercontentofnot
morethan0.2percentonadrybasis
levelnottoexceed1
percentbyweightof
finisheddrypaperor
paperboardfibers.
N,N'Dioleoylethylenediamine
Diphenylamine
Foruseonlyasan
antioxidantforfatty
provideditisusedata
byweightofcoating
solids.
Dipropyleneglycol
Disodiumsaltof1,4dihydro9,10dihydroxyanthracene(CASReg.No.73347805)
Foruseonlyasacatalyst
inthealkalinepulpingof
lignocellulosicmaterials
atlevelsnottoexceed
therawlignocellulosic
materials.
N,N'Distearoylethylenediamine
nDodecylguanidineacetate
nDodecylguanidinehydrochloride
Foruseonlyasan
antimicrobialagentin
paperandpaperboardunder
thefollowingconditions:
1.Forcontactonlywith
nonalcoholicfoodhavinga
pHabove5andprovidedit
isusedatalevelnotto
exceed0.4percentby
weightofthepaperand
paperboard.2.Forusein
theouterplyofmultiwall
paperbagsforcontact
withdryfoodofTypeVIII
describedintableIof
paragraph(c)ofthis
sectionandprovideditis
usedatalevelof0.8
paper.
Foruseonlyasan
paperandpaperboardunder
thefollowingconditions:
1.Forcontactonlywith
nonalcoholicfoodhavinga
pHabove5andprovidedit
isusedatalevelnotto
exceed0.4percentby
weightofthepaperand
paperboard.2.Forusein
theouterplyofmultiwall
paperbagsforcontact
withdryfoodofTypeVIII
describedintableIof
7/30
4/8/2015
paragraph(c)ofthis
sectionandprovideditis
usedatalevelof0.8
paper.
Fattyacidsderivedfromanimalandvegetablefatsandoilsandsaltsofsuchacids,
singleormixed,asfollows:
Aluminum.
Ammonium.
Calcium.
Magnesium.
Potassium.
Sodium.
Zinc.
Ferricchloride
Ferrousammoniumsulfate
Fishoil,hydrogenated
Fishoil,hydrogenated,potassiumsalt
Furcelleranandsaltsoffurcelleranasdescribedin172.655and172.660ofthischapter
Glutaraldehyde(CASReg.No.111308)
Foruseonlyasan
pigmentandfiller
slurriesusedinthe
paperboardatlevelsnot
toexceed300partsper
millionbyweightofthe
slurrysolids.
Glyceryllactostearate
Glycerylmono1,2hydroxystearate
Glycerylmonoricinoleate
Foruseonlyasa
retentionaidand/or
drainageaidemployed
Guargummodifiedbytreatmentwith[beta]diethylaminoethylchloridehydrochloride
operationinthe
paperboard.
Foruseonlyasa
retentionaidand/or
internalsizeemployed
operationinthe
paperboard,andlimitedto
useatalevel:(1)Notto
exceed0.15percentby
Guargummodifiedbytreatmentwithnotmorethan25weightpercentof2,3epoxypropyltri
paperandpaperboard
methylammoniumchloridesuchthatthefinishedproducthasamaximumchlorinecontentof
fibersintendedforusein
4.5percent,amaximumnitrogencontentof3.0percent,andaminimumviscosityin1
contactwithalltypesof
percentbyweightaqueoussolutionof1,000centipoisesat77deg.F,asdeterminedbyRV
foods,except(2)notto
seriesBrookfieldviscometer(orequivalent)usingaNo.3spindleat20r.p.m
exceed0.30pct.byweight
ofthefinisheddried
paperandpaperboard
fibersforusewith
nonalcoholicandnonfatty
foodoftypesidentified
underTypesI,II,IVB,
VIB,VIIB,andVIIIof
tableIinpar.(c)of
thissection.
Foruseonlyasawater
repellentappliedtothe
surfaceofpaperand
paperboardatlevelsnot
toexceed1percentby
N,N,N',N',N[Prime],N[Prime]Hexakis(methoxymethyl)1,3,5triazine2,4,6triaminepolymer
paperboardfibers.The
withstearylalcohol,[alpha]octadecenylomegahydroxypoly(oxy1,2ethanediyl),andalkyl
finishedpaperand
(C20+)alcohols(CASReg.No.130328244)
contactwithaqueousfoods
underconditionsofuseB
throughGasdescribedin
table2ofparagraph(c)
ofthissection.
Hexamethylenetetramine
Hydroquinoneandthemonomethylormonoethylethersofhydroquinone
Foruseonlyas
polymerizationcross
linkingagentforprotein,
includingcasein.
Foruseonlyasan
inhibitorformonomers.
Foruseonlyasa
8/30
4/8/2015
preservativeinclaytype
fillersatalevelnotto
exceedacombinedtotalof
Hydroxymethyl5,5dimethylhydantoin(CASReg.No.27636824),mixturewith1,3
1,200milligrams/kilograms
bis(hydroxymethyl)5,5dimethylhydantoin(CASReg.No.6440580)
hydroxymethyl5,5
dimethylhydantoinand1,3
bis(hydroxymethyl)5,5
dimethylhydantoininthe
filler.
Foruseonlyasadry
strengthandformationaid
Hydroxypropylguargumhavingaminimumviscosityof5,000centipoisesat25deg.C.,as thesheetforming
determinedbyRVseriesBrookfieldviscometerusingaNo.4spindleat20r.p.m.(orother operationinthe
suitablemethod)andusingatestsamplepreparedbydissolving5gramsofmoisturefree manufactureofpaperand
hydroxypropylguargumin495millilitersofa70percentbyweightaqueouspropylene
glycolsolution
levelnottoexceed1.5
percentbyweightof
finisheddrypaperor
paperboardfibers.
Foruseonlyasa
surfactantfordispersions
ofpolyacrylamide
12Hydroxystearicacidpolyethyleneglycolblockcopolymers(CASReg.No.70142346)
retentionanddrainage
producedbythereactionofpolyethyleneglycol(minimummolecularweight200)with12
aidsemployedpriortothe
hydroxystearicacid
andpaperboard.
Foruseonlyatalevel
Imidazoliumcompounds,2(C17andC17unsaturatedalkyl)1[2(C18andC18unsaturated
byweightofthedrypaper
amido)ethyl]4,5dihydro1methyl,methylsulfates(CASReg.No.72749554).
andpaperboard.
Foruseonlyasan
antioxidantforfatty
Isopropylmandpcresols(thymolderived)
provideditisusedasa
byweightofcoating
solids.
Foruseonlyas
Isopropylperoxydicarbonate
Japanwax
Lanolin
Foruseonlyas
Laurylperoxide
Laurylsulfatesalts:
Ammonium.
Magnesium.
Potassium.
Sodium.
Lecithin,hydroxylated
Ligninsulfonateanditscalcium,potassium,andsodiumsalts
Foruseonlyasadeposit
controladditivepriorto
thesheetforming
operationtopreventscale
buildupinthemanufacture
Maleicanhydride,polymerwithethylacrylateandvinylacetate,hydrolyzed(CASReg.No.
ofpaperandpaperboardin
113221695)and/oritsammonium,potassium,andsodiumsalts
contactwithfood,ata
levelnottoexceed0.075
percent(astheacid)by
weightofthedrypaper
andpaperboard.
Foruseonlyasaboiler
wateradditiveatalevel
Methacrylicacidacrylicacidcopolymer(CASReg.No.25751217)
nottoexceed50partsper
millionintheboiler
water.
Foruseonlyasa
retentionaid,
flocculatingagent,and
wetstrengthagent
Nmethyldiallylaminehydrochloridepolymerwithepichlorohydrinhavinganitrogencontent
employedinthe
of4.8to5.9percent(Kjeldahldrybasis)suchthata20percentbyweightaqueous
solutionhasaminimumviscosityof30centipoisesandmaximumviscosityof100
paperboardpriortothe
centipoisesat25deg.C,asdeterminedbyLVFModelBrookfieldviscometerusingaNo.1
sheetformingoperation
spindleat60r.p.m.(orequivalentmethod)
andlimitedtouseata
levelnottoexceed1.5
Foruseonlyasan
absorbencyandpitch
Methylnaphthalenesulfonicacidformaldehydecondensate,sodiumsalt
9/30
4/8/2015
NmethylN(talloilacyl)taurine,sodiumsalt(CASReg.No.61791411)
operation.
Foruseonlytocontrol
scaleformationinthe
sheetformingoperationat
alevelnottoexceed
thedrypaperand
paperboard.
Mineraloil,white
Foruseonlyasan
emulsifierforrosinbased
Mono,di,tri(1methyl1phenylethyl)phenol,ethoxylated,sulfated,ammoniumsaltwith sizingatalevelnotto
anaverageof12to16molesofethyleneoxide(CASReg.No.68130712)
exceed0.03percentby
paperandpaperboard.
Monoglyceridecitrate
Foruseasadispersant
fortitaniumdioxide
suspensionsatalevelnot
toexceed0.68percentby
weightoftitanium
dioxide.Thefinished
Monoisopropanolamine(CASReg.No.78966)
beusedincontactwith
allfoodtypesunder
conditionsofuseE
throughGdescribedin
ofthissection.
Mustardseedoil,sulfated,ammonium,potassium,orsodiumsalt
Naphthalenesulfonicacidformaldehydecondensate,sodiumsalt
Foruseonlyasan
absorbencyandpitch
operation.
Nitrocellulose,10.912.2%nitrogen
Oleicacid,sulfated,ammonium,potassium,orsodiumsalt
NOleoylN'stearoylethylenediamine
Oxystearin
Foruseonlyassetting
agentforprotein.
waterrepellentandused
atalevelnottoexceed8
poundspertonofthe
finishedpaperor
Pentanoicacid,4,4bis[(gammaomegaperfluoroC820alkyl)thio]derivatives,compounds
paperboardwhensuchpaper
orpaperboardisusedin
withdiethanolamine(CASReg.No.71608612)
foodsunderconditionsof
useEthroughHdescribed
intable2ofparagraph
(c)ofthissection.
waterrepellentatalevel
byweightofthefinished
Perfluoroalkylacrylatecopolymer(CASReg.No.92265811)containing35to40weight
percentfluorine,producedbythecopolymerizationofethanaminium,N,N,Ntrimethyl2[(2 paperandpaperboardin
methyl1oxo2propenyl)oxy],chloride2propenoicacid,2methyl,oxiranylmethyl
foodsunderconditionsof
ester2propenoicacid,2ethoxyethylesterand2propenoicacid,2<(heptadecafluoro
useC,D,E,F,G,orH
octyl)sulfonyl]methylamino]ethylester
describedintable2of
paragraph(c)ofthis
section.
Paraformaldehyde
perfluoroalkylactivesby
weightofthefinished
paperandpaperboardin
foodsunderconditionof
Perfluoroalkylsubstitutedphosphateesteracids,ammoniumsaltsformedbythereactionof useHasdescribedin
2,2bis[([gamma],[omega]perfluoroC420alkylthio)methyl]1,3propanediol,
ofthissectionandin
polyphosphoricacidandammoniumhydroxide
contactwithfoodoftypes
III,IVA,V,VIIA,and
IXdescribedintable1of
paragraph(c)ofthis
10/30
4/8/2015
ofuseCthroughGas
describedintable2of
paragraph(c)ofthis
section.
Complyingwith178.3700of
thischapter.
Foruseonlyasa
componentofinternal
Petroleumasphalt,steamandvacuumrefinedtomeetthefollowingspecifications:
sizingofpaperand
Softeningpoint88deg.Cto93deg.C,asdeterminedbyASTMmethodD3676,"Standard
paperboardintendedfor
TestMethodforSofteningPointofBitumen(RingandBallApparatus)"penetrationat25 useincontactonlywith
deg.Cnottoexceed0.3mm,asdeterminedbyASTMmethodD573(Reapproved1978),
rawfruits,raw
"StandardTestMethodforPenetrationofBituminousMaterials,"whichareincorporatedby vegetables,anddryfood
reference(CopiesmaybeobtainedfromtheAmericanSocietyforTestingMaterials,100
ofthetypeidentified
BarrHarborDr.,WestConshohocken,Philadelphia,PA194282959,ormaybeexaminedatthe underTypeVIIIoftable1
NationalArchivesandRecordsAdministration(NARA).Forinformationontheavailability inparagraph(c)ofthis
ofthismaterialatNARA,call2027416030,orgoto:
section,andprovidedthat
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.) theasphaltisusedata
andmaximumweightlossnottoexceed3%whendistilledto371deg.C,nortoexceedan
additional1.1%whenfurtherdistilledbetween371deg.Candthermaldecomposition
paperandpaperboard
fibers.
Petroleumwax,synthetic
thischapter.
Foruseonlyas
Phenothiazine
antioxidantindryrosin
size.
Foruseonlyas
polymerizationcatalystin
melamineformaldehyde
modifiedalkydcoatings
Phenylacidphosphate
andlimitedtouseata
weightofthecoating
solids.
Petrolatum
Foruseonlyas
antioxidantindryrosin
sizeandlimitedtouseat
Phenyl[beta]naphthylamine
alevelnottoexceed0.4%
byweightofthedryrosin
size.
Foruseasanadjuvant
operationtocontrolpitch
andscaleformationinthe
Phosphoricacidestersandpolyesters(andtheirsodiumsalts)oftriethanolamineformed useincontactwithfood
bythereactionoftriethanolaminewithpolyphosphoricacidtoproduceamixtureofesters onlyofthetypes
havinganaveragenitrogencontentof1.5percentandanaveragephosphoruscontentof32 identifiedinparagraph
percent(asPO4)
(c)ofthissection,table
1,underTypesI,IV,V,
VII,VIII,andIX,and
usedatalevelnotto
weightofdrypaperor
paperboardfibers.
aidandretentionaid
employedpriortothe
Poly[acrylamideacrylicacidN(dimethylaminomethyl)acrylamide],producedbyreacting
andpaperboardforusein
2.40to3.12partsbyweightofpolyacrylamidewith1.55partsdimethylamineand1part
contactwithfattyfoods
formaldehyde,andcontainingnomorethan0.2percentmonomerasacrylamide
underconditionsofuse
conditionsofuseE,F,
andG.
Foruseonlyasa
retentionanddrainageaid
Poly(2aminoethylacrylatenitrateco2hydroxypropylacrylate)producedwhenonemoleof employedpriortothe
hydroxypropylacrylateandthreemolesofacrylicacidarereactedwiththreemolesof
ethylenimineandthreemolesofnitricacid,suchthata35percentbyweightaqueous
solutionhasaminimumviscosityof150centipoisesat72deg.F.,asdeterminedbyRVF andpaperboardatalevel
seriesBrookfieldviscometer(orequivalent)usingaNo.2spindleat20r.p.m
byweightofdrypaperor
paperboardfiber.
Foruseonlyasanagent
inmodifyingstarchesand
starchgumsusedinthe
productionofpaperand
Polyacrolein(1part)sodiumbisulfite(0.7part)adduct,containingexcessbisulfite
(ratioofexcessbisulfitetoadductnottoexceed1.5to1)
11/30
4/8/2015
useatalevelnotto
exceed0.09mg/in2ofthe
finishedpaperand
paperboard.
aid,retentionaid,or
drystrengthagent
employedpriortothe
Poly[acrylamideacrylicacidN(dimethylaminomethyl)acrylamide](C.A.RegistryNo.53800
andpaperboardatalevel
412),producedbyreacting9.616.4partsbyweightofpolyacrylamidewith1.6parts
dimethylamineand1partformaldehyde,andcontainingnomorethan0.2%monomeras
byweightoffinisheddry
acrylamide,suchthata20%aqueoussolutionhasaminimumviscosityof4,000cPat25
paperandpaperboard
deg.C.,asdeterminedbyBrookfieldviscometermodelRVT,usingaNo.5spindleat20
fibers,whensuchpaperor
r/min(orequivalentmethod)
paperboardisusedin
contactwithfattyfoods
underconditionsofuse
conditionsofuseE,F,
andG.
Foruseonlyasa
retentionaidand
Polyamideepichlorohydrinmodifiedresinproducedbyreactingadipicacidwithdiethylene
tothesheetforming
triaminetoproduceabasicpolyamidewhichismodifiedbyreactionwithformicacidand
operationinthe
formaldehydeandfurtherreactedwithepichlorohydrininthepresenceofammonium
hydroxidetoformawatersolublecationicresinhavinganitrogencontentof1316
percent(Kjeldahl,drybasis)suchthata35percentbyweightaqueoussolutionhasa
levelnottoexceed0.2
minimumviscosityof75centipoisesat25deg.C,asdeterminedbyBrookfieldviscometer
percentdryresinby
usingaNo.1spindleat12r.p.m
weightoffinisheddry
paperorpaperboard
fibers.
Foruseonlyunderthe
Asaretentionaid
employedpriortothe
touseatalevelnotto
Polyamideepichlorohydrinwatersolublethermosettingresins[CASReg.No.68583799]
exceed0.12percentby
preparedbyreactingadipicacidwithdiethylenetriaminetoformabasicpolyamideand
weightofdrypaperor
furtherreactingthepolyamidewithanepichlorohydrinanddimethylaminemixturesuchthat
paperboard.2.The
thefinishedresinshaveanitrogencontentof17.0to18.0percentofadrybasis,and
finishedpaperor
thata30percentbyweightaqueoussolutionhasaminimumviscosityof350centipoisesat
20deg.C,asdeterminedbyaBrookfieldviscometerusingaNo.3spindleat30r.p.m.(or
contactwithfoodonlyof
equivalentmethod)
thetypesidentifiedin
paragraph(c)ofthis
section,table1,under
typesIandIVBandunder
conditionsofuse
conditionsofuseFandG.
Foruseonlyasawet
strengthagentand/or
Polyamideepichlorohydrinwatersolublethermosettingresin(CASReg.No.96387483)
operationinthe
preparedbyreactingNmethylbis(3aminopropyl)aminewithoxalicacidandureatoforma manufactureofpaperand
basicpolyamideandfurtherreactingthepolyamidewithepichlorohydrin
levelnottoexceed1.5
percentbyweightofdry
paperandpaperboard
fibers.
Foruseonlyinthe
Polyamideepichlorohydrinwatersolublethermosettingresinspreparedbyreactingadipic paperboardunder
acid,isophthalicacid,itaconicacidordimethylglutaratewithdiethylenetriamineto
conditionssuchthatthe
formabasicpolyamideandfurtherreactingthepolyamidewithoneofthefollowing:
resinsdonotexceed1.5
paperorpaperboard.
Epichlorohydrin.
Epichlorohydrinandammoniamixture.
Epichlorohydrinandsodiumhydrosulfitemixture.
Foruseonlyasa
operationinthe
Polyamidoamineethyleneimineepichlorohydrinresinpreparedbyreactinghexanedioicacid,
N(2aminoethyl)1,2ethanediamine,(chloromethyl)oxirane,ethyleneimine(aziridine),and
paperboardatalevelnot
polyethyleneglycol,partlyneutralizedwithsulfuricacid(CASReg.No.167678457)
toexceed0.12percent
resinbyweightofthe
12/30
4/8/2015
finisheddrypaperor
paperboard.
Foruseonlyasawet
operationinthe
Polyamidolepichlorohydrinmodifiedresinproducedbyreactingglutaricaciddimethyl
paperboard,andusedata
esterwithdiethylenetriaminetoproduceabasicpolyamidewhichismodifiedbyreaction
levelnottoexceed2.5
withformaldehydeandfurtherreactedwithepicholorohydrintoformawatersoluble
cationicresinhavinganitrogencontentof10.911.9percentandachlorinecontentof
paperandpaperboard
13.814.8percent,onadrybasis,andaminimumviscosity,in12.5percentbyweight
fiberswhensuchpaperor
aqueoussolution,of10centipoisesat25deg.C,asdeterminedbyaBrookfieldModelLVF
paperboardisusedin
viscometerusingaNo.1spindleat60r.p.m.(orequivalentmethod)
contactwithfoodunder
conditionsofuseE
throughGdescribedin
ofthissection.
Foruseonlyasa
flocculant,drainageaid,
formationaid,retention
Polyamineepichlorohydrinresinproducedbythereactionofepichlorohydrinwith
aid,orstrengthadditive
monomethylaminetoformaprepolymerandfurtherreactionofthisprepolymerwith
employedpriortothe
N,N,N',N'tetramethylethylenediaminesuchthatthefinishedresinhavinganitrogen
contentof11.6to14.8percentandachlorinecontentof20.8to26.4percentanda
minimumviscosity,in25percentbyweightaqueoussolution,of500centipoisesat25deg.
andpaperboard,andused
C,asdeterminedbyLVseriesBrookfieldviscometerusingaNo.2spindleat12r.p.m.(or
atalevelnottoexceed
byotherequivalentmethod)
drypaperandpaperboard
fibers.
Foruseonlyasa
clarifierinthetreatment
PolyamineepichlorohydrinresinproducedbythereactionofN,Ndimethyl1,3
ofinfluentwatertobe
propanediaminewithepichlorohydrinandfurtherreactedwithsulfuricacid,Chemical
usedinthemanufactureof
AbstractsServiceRegistryNumber[27029410],suchthatthefinishedresinhasamaximum
paperandpaperboard,and
nitrogencontentof14.4percent(drybasis)andaminimumviscosityin30percentby
usedatalevelnotto
weightaqueoussolution(pH46)of50centipoisesat25deg.C,asdeterminedby
exceed20partsper
BrookfieldLVTmodelviscometer,usingaNo.1spindleat12r.p.m.(orequivalentmethod)
millionoftheinfluent
water.
Foruseonlyasa
wetstrengthagentand/or
Polyamineepichlorohydrinwatersolublethermosettingresinproducedbyreacting
epichlorohydrinwith:(i)polyaminescomprisingatleast95percentbyweightC4toC6
aliphaticdiaminesand/ortheirselfcondensationproducts,and/or(ii)prepolymers
operationinthe
producedbyreacting1,2dichloroethanewiththepolyaminesin(i).Thefinishedresinhas manufactureofpaperand
anitrogencontentof5.0to9.0percent,achlorinecontentof18.0to35.0percentona paperboard,andusedata
drybasis,andaminimumviscosity,ina25percentbyweightaqueoussolution,of50
levelnottoexceed1
centipoisesat20deg.C(68deg.F),asdeterminedbyBrookfieldHATmodelviscometer
usingaNo.1Hspindleat50r.p.m.(orequivlentmethod)
paperandpaperboard
fibers.
Foruseonlyasawet
Polyamineepichlorohydrinwatersolublethermosettingresinproducedbyreacting
strengthagentand/or
epichlorohydrinwith:(i)polyaminescomprisingatleast95percentbyweightC4toC6
aliphaticdiaminesand/ortheirseIfcondensationproductsand/or(ii)
hexamethylenediamine,and/or(iii)bis(hexamethylene)triamineandhigherhomologues,
operationinthe
and/or(iv)prepolymersproducedbyreacting1,2dichloroethanewiththepolyaminesin(i)
and/or(ii)and/or(iii).Thefinishedresinhasanitrogencontentof5.0to9.0percent,
achlorinecontentof18.0to35.0percentonadrybasis,andaminimumviscosity,ina
levelnottoexceed1
25percentbyweightaqueoussolution,of50centipoisesat20deg.C(68deg.F),as
determinedbyBrookfieldHATmodelviscometerusingaNo.1Hspindleat50r.p.m.(or
paperandpaperboard
equivalentmethod)
fibers.
Foruseonlyasawet
strengthagentand/or
Polyamineepichlorohydrinwatersolublethermosettingresinpreparedbyreacting
hexamethylenediaminewith1,2dichloroethanetoformaprepolymerandfurtherreacting
thisprepolymerwithepichlorohydrin.Thisresinisthenreactedwithnitrilotris
operationinthe
(methylenephosphonicacid),pentasodiumsalt,suchthatthefinishedresinhasanitrogen
contentof5.05.3percentachlorinecontentof29.731.3percentandaphosphorus
contentof2.02.2percent,onadrybasis,andaminimumviscosity,in25percentby
levelnottoexceed1
weightaqueoussolution,of50centipoisesat25deg.C.,asdeterminedonaBrookfield
HATmodelviscometerusingaNo.1Hspindleat50r.p.m.(orequivalentmethod)
paperandpaperboard
fibers.
Foruseonlyasa
retentionaidand/or
flocculentemployedprior
Polyamineresinproducedbythereactionof1,2dichloroethanewith
tothesheetforming
bis(hexamethylene)triamineandhigherhomologuessuchthatthefinishedresinhasa
operationinthe
nitrogencontentof13.015.0percentonadrybasis,andaminimumviscosityin25
percentbyweightaqueoussolutionof75centipoisesat25deg.C.,asdeterminedby
BrookfieldHATmodelviscometerusingaNo.1spindleat50r.p.m.(orequivalentmethod) levelnottoexceed0.1
paperorpaperboard
fibers.
13/30
4/8/2015
Foruseonlyasawet
Polyaminoamideepichlorohydrinmodifiedresinproducedbyreactingadipicacidwith
strengthagentand/or
diethylenetriaminetoproduceapolyamidewhichismodifiedbyreactionwith
diethylaminopropylamineandfurtherreactedwithdichloroethylethertoformapolyamide priortothesheetforming
intermediate.Thispolyamideintermediateisthenreactedwithepichlorohydrinsuchthat operationinthe
thefinishedresinshaveanitrogencontentof10.912.4percent(Kjeldahl,drybasis)and manufactureofpaperand
aminimumviscosityin40percentbyweightaqueoussolutionof250centipoisesat22deg. paperboard,andusedata
C,asdeterminedbyaBrookfieldModelLVTviscometerusingaNo.2spindleat30r.p.m. levelnottoexceed0.5
(orequivalentmethod)
finisheddrypaperand
paperboard.
Foruseonlyasprovided
Polybutene,hydrogenatedcomplyingwiththeidentityprescribedunder178.3740(b)ofthis
in175.300,178.3740and
chapter
178.3860ofthischapter.
Foruseonly:1.Asa
pigmentdispersantand/or
retentionaidpriortothe
Poly(diallyldimethylammoniumchloride)(CASReg.No.26062793)producedbythe
andpaperboard,andused
polymerizationof(diallyldimethylammoniumchloride)sothatthefinishedresinhasa
atalevelnottoexceed
nitrogencontentof8.66+/0.4percentonadryweightbasisandaminimumviscosityina 10poundsofactive
40percentbyweightaqueoussolutionof1,000centipoisesat25deg.C(77deg.F),
polymerpertonof
determinedbyLVFModelBrookfieldViscometerusingaNo.3spindleat30r.p.m.(or
finishedpaperand
equivalentmethod).Thelevelofresidualmonomerisnottoexceed1percentbyweightof paperboard.2.Asa
thepolymer(drybasis)
pigmentdispersantin
coatingsatalevelnotto
exceed3.5poundsof
activepolymerpertonof
finishedpaperand
paperboard.
Foruseonlyasa
Poly(diallyldimethylammoniumchloride)(CASReg.No.26062793)producedbythe
tothesheetforming
polymerizationofdiallyldimethylammoniumchloridesothatthefinishedresinhasa
operationinthe
nitrogencontentof8.66+/0.4percentonadrybasisandaminimumviscosityina15
weightpercentaqueoussolutionof10centipoisesat25deg.C(77deg.F),asdetermined
byLVFModelBrookfieldviscometerusingaNo.1spindleat60r/min(orequivalent
levelnottoexceed10
method).Thelevelofresidualmonomerisnottoexceed1weightpercentofthepolymer
mg/L(10partsper
(drybasis)
million)ofinfluent
water.
Poly(1,2dimethyl5vinylpyridiniummethylsulfate)havinganitrogencontentof5.7to
Foruseonlyasan
7.3percentandasulfurcontentof11.7to13.3percentbyweightonadrybasisand
adjuvantemployedinthe
havingaminimumviscosityin30percentbyweightaqueoussolutionof2,000centipoises manufactureofpaperand
at25deg.C.,asdeterminedbyLVseriesBrookfieldviscometer(orequivalent)usinga
No.4spindleat60r.p.m
sheetformingoperation.
Foruseonlyasasurface
sizingcompoundapplied
afterthesheetforming
Polyesterresinproducedbyreactingdimethylolpropionicacid(CASRegistryNo.4767037)
operationinthe
asacomonomer,atnomorethan30percentbyweightoftotalpolymersolidsinreaction
with2,2dimethyl1,3propanediol,phthalicanhydrideandisophthalicacid,suchthatthe
polyesterresinhasaviscosityof200600centipoisesat80deg.Fasdeterminedbya
useatlevelsnotto
BrookfieldRVTviscometerusinganumber3spindleat50rpm(orequivalentmethod)
exceed0.1percentby
weightoffinisheddry
paperorpaperboard.
Foruseonlyascomponent
ofcoatingsthatcontact
foodonlyofthetype
identifiedunderTypeVII
Polyethylene,oxidizedcomplyingwiththeidentityprescribedin177.1620(a)ofthis
Boftable1inparagraph
chapter
(c)ofthissection,and
nottoexceed50percent
byweightofthecoating
solids.
Foruseonlyasa
Polyethyleneaminemixtureproducedwhen1moleofethylenedichloride,1.05molesof
ammonia,and2molesofsodiumhydroxidearemadetoreactsothata10percentaqueous
solutionhasaminimumviscosityof40centipoisesat77deg.F,asdeterminedby
operationinthe
BrookfieldviscometerusingaNo.1spindleat60r.p.m
paperboard.
Foruseonlyasan
adjuvantemployedinthe
Polyethyleneglycol(200)dilaurate
sheetformingoperation.
Polyethyleneglycol(400)dioleate
Polyethyleneglycol(400)estersofcoconutoilfattyacids
Polyethyleneglycol(600)estersoftalloilfattyacids
Polyethyleneglycol(400)monolaurate
Polyethyleneglycol(600)monolaurate
Polyethyleneglycol(400)monooleate
Polyethyleneglycol(600)monooleate
14/30
4/8/2015
Polyethyleneglycol(400)monostearate
Polyethyleneglycol(600)monostearate
Polyethyleneglycol(3,000)monostearate
Polyethylenimine,producedbythepolymerizationofethylenimine
Poly(isobutene)/maleicanhydrideadduct,diethanolaminereactionproduct.Themoleratio
ofpoly(isobutene)/maleicanydrideadducttodiethanolamineis1:1
Foruseonlyasan
adjuvantemployedpriorto
sheetformationinpaper
makingsystemsoperatedat
apHof4.5orhigher,and
nottoexceed5%byweight
offinisheddrypaperor
paperboardfibers.
Foruseonlyasa
surfactantfordispersions
ofpolyacrylamide
retentionanddrainage
aidsemployedpriortothe
sheetformationoperation
inthemanufactureof
paperandpaperboard.
Foruseonlyasacoating
adjuvantforcontrolling
viscositywhenusedata
byweightofcoating
solids.
adjuvantforcontrolling
Polymethacrylicacid,sodiumsalt,havingaviscosityin40percentbyweightaqueous
viscositywhenusedata
solutionof400700centipoisesat25deg.C,asdeterminedbyLVseriesBrookfield
byweightofcoating
solids.
Foruseonlyasa
Poly[(methylimino)(2hydroxytrimethylene)hydrochloride]producedbyreactionof1:1molar
ratioofmethylamineandepichlorohydrinsothata31percentaqueoussolutionat25deg.
ChasaStokesviscosityrangeof2.54.0asdeterminedbyASTMmethodD154576
operationinsuchan
(Reapproved1981),"StandardTestMethodforViscosityofTransparentLiquidsbyBubble
amountthatfinishedpaper
TimeMethod,"whichisincorporatedbyreference.CopiesmaybeobtainedfromtheAmerican
andpaperboardwill
SocietyforTestingMaterials,100BarrHarborDr.,WestConshohocken,Philadelphia,PA
194282959,ormaybeexaminedattheNationalArchivesandRecordsAdministration(NARA).
levelnotinexcessof1
ForinformationontheavailabilityofthismaterialatNARA,call2027416030,orgoto:
Foruseonlytoimprove
Poly[oxyethylene(dimethyliminio)ethylene(dimethyliminio)ethylenedichloride]produced drystrengthofpaperand
byreactingequimolarquantitiesofN,N,N,Ntetramethylethylenediamineanddichlorethyl paperboardandasa
ethertoyieldasolutionofthesolidpolymerindistilledwaterat25deg.Cwitha
retentionanddrainageaid
reducedviscosityofnotlessthan0.15deciliterpergramasdeterminedbyASTMmethod
employedpriortothe
D124379,"StandardTestMethodforDiluteSolutionViscosityofVinylChloride
Polymers,"whichisincorporatedbyreference.CopiesmaybeobtainedfromtheAmerican
SocietyforTestingMaterials,100BarrHarborDr.,WestConshohocken,Philadelphia,PA
194282959,ormaybeexaminedattheNationalArchivesandRecordsAdministration(NARA). touseatalevelnotto
ForinformationontheavailabilityofthismaterialatNARA,call2027416030,orgoto: exceed0.1percentby
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.). weightofthefinisheddry
paperandpaperboard
Thefollowingformulaisusedfordeterminingreducedviscosity:
fibers.
Polymethacrylicacid,sodiumsalt,havingaviscosityin30percentbyweightaqueous
solutionof125325centipoisesat25deg.CasdeterminedbyLVseriesBrookfield
Reducedviscosityintermsofdeciliterspergram=(tt0)/(tC),
where:
t=Solutioneffluxtime
to=Watereffluxtime
C=Concentrationofsolutionintermsofgramsperdeciliter
Polypropyleneglycol(minimummolecularweight1,000)
Potassiumpersulfate
2Propenoicacid,telomerwithsodium2methyl2[(1oxo2propenyl)amino]1propane
sulfonateandsodiumphosphinate(CASReg.No.110224992)
Foruseonlyasadeposit
controladditiveemployed
operationinthe
paperboardandatalevel
byweightofthedrypaper
andpaperboard.
Propyleneglycolalginate
Proteinhydrolysatefromanimalhidesorsoybeanproteincondensedwitholeicand/or
stearicacid
Rapeseedoil,sulfatedammonium,potassium,orsodiumsalt
Ricebranoil,sulfatedammonium,potassium,orsodiumsalt
Rosinandrosinderivatives
Asprovidedin178.3870of
thischapter.
Foruseonlyasa
componentofpolyolefin
coatingswith177.1520of
thischapteratalevel
15/30
4/8/2015
nottoexceed3percentby
weight.Thefinished
coatingwillbeusedonly
thatcontactfoodoftypes
Siloxanes(silicones),dimethyl,isopropylmethyl,methyl1methylC949alkyl(CASReg.
VIAandVIBoftable1
No.144635085)
inparagraph(c)ofthis
section,andunder
conditionsofuseC,D,
andE,asdescribedin
table2inparagraph(c)
ofthissection,witha
maximumhotfill
temperatureof200deg.F
(94deg.C).
Foruseonlyasa
preservativeinpolymer
latexemulsionsatalevel
Silverchloridecoatedtitaniumdioxide
nottoexceed2.2parts
permillion(basedon
silverionconcentration)
inthedrycoating.
Foruseonlyasadry
strengthandformationaid
Sodiumcarboxymethylguargumhavingaminimumviscosityof2,700centipoisesat25deg.C thesheetforming
after24hoursasdeterminedbyRVseriesBrookfieldviscometer(orequivalent)usinga
operationinthe
No.4spindleat20r.p.m.andusingatestsamplepreparedbydissolving8gramsof
sodiumcarboxymethylguargumin392millilitersof0.2percentbyweightaqueoussodium paperboardandusedata
ophenylphenatesolution
weightoffinisheddry
paperorpaperboard
fibers.
Sodiumdioctylsulfosuccinate
Foruseonlyas
Sodiumformaldehydesulfoxylate
Sodiumhypochlorite
Foruseonlyasan
absorbencyandpitch
SodiumNmethylNoleyltaurate
operation.
Foruseonly:1.Atlevels
nottoexceed0.2%by
weightoflubricantsor
releaseagentsappliedat
levelsnottoexceed1lb.
pertonoffinishedpaper
orpaperboard.2.Asan
Sodiumnitrite
anticorrosionagentat
levelsnottoexceed0.2%
byweightofwaxemulsions
usedasinternalsizingin
andpaperboardpriorto
thesheetforming
operation.
Sodiumpersulfate
Sodiumpolyacrylate
Sodiumpoly(isopropenylphosphonate)(CASReg.No.118632181)
Sodiumzincpotassiumpolyphosphate(CASReg.No.65997173)
Foruseonly:1.Asa
thickeningagentfor
naturalrubberlatex
coatings,provideditis
usedatalevelnotto
ofcoatingsolids.2.Asa
pigmentdispersantin
exceed0.25percentby
weightofpigment.
Foruseonlyinpapermill
boilers.
Foruseonlyasapigment
dispersantincoatingsat
alevelnottoexceed1
percentbyweightof
pigment.
Spermoil,sulfated,ammonium,potassium,orsodiumsalt
Stannousoleate
Stearyl2lactylicacidanditscalciumsalt
Styrenebutadienecopolymersproducedbycopolymerizingstyrenebutadienewithoneormore
ofthemonomers:acrylamide,acrylicacid,fumaricacid,2hydroxyethylacrylate,itaconic
acid,methacrylicacid,andNmethylolacrylamide(CASReg.No.53504317).Thefinished
16/30
4/8/2015
copolymersshallcontainnotmorethan10weightpercentoftotalpolymerunitsderived
fromacrylicacid,fumaricacid,2hydroxyethylacrylate,itaconicacid,andmethacrylic
acid,andshallcontainnotmorethan3weightpercentoftotalpolymerunitsderivedfrom
Nmethylolacrylamide,andshallcontainnotmorethan2weightpercentofpolymerunits
derivedfromacrylamide.
Styrenemaleicanhydridecopolymer,amidated,ammoniumsodiumsalthaving,ina25
sizeatalevelnotto
percentbyweightaqueoussolutionatpH8.8,aminimumviscosityof600centipoisesat25
deg.CasdeterminedbyBrookfieldmodelLVTviscometerusingaNo.3spindleat60r.p.m.
ofpaperorpaperboard
(orequivalentmethod)
substrate.
Foruseonly:1.Asa
coatingthickeningagent
atalevelnottoexceed
1%byweightofcoating
Styrenemaleicanhydridecopolymer,sodiumsalt(minimummolecularweight30,000)
solids.2.Assurfacesize
atalevelnottoexceed
1%byweightofpaperor
paperboardsubstrate.
thickeningagentata
Styrenemethacrylicacidcopolymer,potassiumsalt(minimummolecularweight30,000)
weightofcoatingsolids.
Foruseonlyasa
componentofpetroleumwax
and/orsyntheticpetroleum
waxcomplyingwith
178.3710or178.3720of
thischapteratlevelsnot
toexceed5percentby
weightofthewax:1.
UnderconditionsofuseF
Syntheticwaxpolymerpreparedbythecatalyticpolymerizationofalphaolefinssuchthat
andGdescribedintable2
thepolymerhasamaximumiodinenumberof18andaminimumnumberaveragemolecular
weightof2,400
sectionforallfoods.2.
UnderconditionsofuseE
describedintable2of
paragraph(c)ofthis
sectionforfoodTypesI,
II,IVB,VI,VIIBand
VIIIasdescribedintable
1ofparagraph(c)ofthis
section.
Tallow
Tallowalcohol
Tallowalcohol,hydrogenated
Tallowfattyacid,hydrogenated
Tallowhydrogenated
Tallowsulfated,ammonium,potassium,orsodiumsalt
foraminoresins.
Foruseonlyasacatalyst
inthealkalinepulpingof
lignocellulosicmaterials
1,4,4a,9aTetrahydro9,10anthracenedione(CASReg.No.56136142)
atlevelsnottoexceed
therawlignocellulosic
materials.
Foruseonlyasa
flocculent,drainageaid
orretentionaidemployed
N,N,N',N'Tetramethylethylenediaminepolymerwithbis(2chloroethyl)ether,first
reactedwithnotmorethan5percentbyweight1chloro2,3epoxypropaneandthenreacted operationinthe
withnotmorethan5percentbyweightpoly(acrylicacid)suchthata50percentby
weightaqueoussolutionoftheproducthasanitrogencontentof4.74.9percentand
useatalevelnotto
viscosityof350700centipoisesat25deg.CasdeterminedbyLVseriesBrookfield
exceed0.2percentby
viscometerusingaNo.2spindleat60r.p.m.(orbyotherequivalentmethod)
paperandpaperboard
fibers.
Tetraethylenepentamine
TetrasodiumN(1,2dicarboxyethyl)Noctadecylsulfosuccinamate
Foruseonlyasan
emulsifierinaqueous
dispersionsofrosinsizes
complyingwith178.3870(a)
(4)ofthischapterand
limitedtousepriorto
thesheetforming
operationinthe
paperboardatalevelnot
toexceed0.02pctby
weightoffinishedpaper
andpaperboard.
ForuseonlytoadjustpH
duringthemanufactureof
17/30
4/8/2015
Triethanolamine
Triethyleneglycoladipicacidmonoesterproducedbyreactingequimolarquantitiesof
triethyleneglycolandadipicacid
Triethylenetetramine
1,3,5Triethylhexahydro1,3,5triazine(CASRegistryNo.7779273)
aminoresinspermittedfor
useascomponentsofpaper
andpaperboard.
Foruseonlyasacurl
controlagentatalevel
nottoexceed2%byweight
ofcoatedoruncoated
paperandpaperboard.
foraminoresins.
Foruseonlyasan
antimicrobialagentfor
coating,binder,pigment,
filler,sizing,and
similarformulationsadded
priortotheheatdrying
stepinthemanufactureof
paperandpaperboardand
between0.05and0.15
formulation.
Foruseonlyasanoil
repellentatalevelnot
toexceed0.087lb(0.046
lboffluorine)per1,000
ft2oftreatedpaperor
paperboard,asdetermined
byanalysisfortotal
fluorineinthetreated
paperorpaperboard
Undecafluorocyclohexanemethanolestermixtureofdihydrogenphosphate,compoundwith2,2' fluorinewhichmightbe
iminodiethanol(1:1)hydrogenphosphate,compoundwith2,2'iminodiethanol(1:1)and
P,P'dihydrogenpyrophosphate,compoundwith2,2'iminodiethanol(1:2)wheretheester
mixturehasafluorinecontentof48.3pctto53.1pctasdeterminedonasolidsbasis
isusedincontactwith
foodonlyofthetypes
identifiedinparagraph
1,underTypesIVA,V,
VIIA,VIII,andIX,and
undertheconditionsof
useBthroughGdescribed
intable2ofparagraph
(c)ofthissection.
Viscoserayonfibers
Wax,petroleum
Xanthangum,conformingtotheidentityandspecificationsprescribedin172.695ofthis
chapter,exceptthattheresidualisopropylalcoholshallnotexceed6,000partsper
million
Xylenesulfonicacidformaldehydecondensate,sodiumsalt
ZeoliteNaA(CASReg.No.68989220)
Zincformaldehydesulfoxylate
thischapter.
Foruseonlyatamaximum
levelof0.125percentby
weightoffinishedpaper
asasuspensionaidor
stabilizerforaqueous
pigmentslurriesemployed
inthemanufactureof
paperandpaperboard.
Foruseonlyasan
absorbencyandpitch
operation.
Foruseasapigment
extenderatlevelsnotto
exceed5.4percentby
weightofthefinished
paperandpaperboard.
Foruseonlyas
Zincoctoate
Zirconiumoxide
Foruseonlyasa
componentofwaterproof
coatingswherethe
zirconiumoxideispresent
atalevelnottoexceed1
drypaperorpaperboard
fiberandwherethe
zirconiumoxideis
producedbyhydrolysisof
zirconiumacetate.
18/30
4/8/2015
(b)Substancesidentifiedinparagraphs(b)(1)and(2)ofthissectionmaybeusedascomponentsofthefood
contactsurfaceofpaperandpaperboard,providedthatthefoodcontactsurfaceofthepaperorpaperboardcomplies
withtheextractiveslimitationsprescribedinparagraph(c)ofthissection.
(1)Substancesidentifiedin175.300(b)(3)ofthischapterwiththeexceptionofthoseidentifiedinparagraphs(b)
(3)(v),(xv),(xx),(xxvi),(xxxi),and(xxxii)ofthatsectionandparagraph(a)ofthissection.
(2)Substancesidentifiedinthisparagraph(b)(2)follow:
Listofsubstances
Acrylamidecopolymerizedwithethylacrylateand/orstryeneand/ormethacrylicacid,
subsequentlyreactedwithformaldehydeandbutylalcohol
Acrylamidecopolymerizedwithethyleneandvinylchlorideinsuchamannerthatthe
finishedcopolymershaveaminimumweightaveragemolecularweightof30,000andcontain
notmorethan3.5weightpercentoftotalpolymerunitsderivedfromacrylamide,andin
suchamannerthattheacrylamideportionmayormaynotbesubsequentlypartially
hydrolyzed
Limitations
Foruseonlyascoatings
orcomponentsofcoatings.
Foruseonlyincoatings
2Acrylamido2methylpropanesulfonicacid,homopolymer,sodiumsalt(CASReg.No.35641 atalevelnottoexceed
599)
0.01mg/in2
Acrylicandmodifiedacrylicpolymers
thischapter.
Acryliccopolymersproducedbycopolymerizing2ormoreoftheacrylatemonomersbutyl
acrylate,ethylacrylate,ethylmethacrylate,methylacrylate,methylmethacrylate,andn
propylmethacrylate,orproducedbycopolymerizingoneormoreofsuchacrylatemonomers
togetherwithoneormoreofthemonomersacrylicacid,acrylonitrile,butadiene,2ethyl
hexylacrylate,fumaricacid,glycidylmethacrylate,nhexylmethacrylate,itaconicacid,
methacrylicacid,styrene,vinylacetate,vinylchloride,andvinylidenechloride.The
finishedcopolymersshallcontainatleast50weightpercentofpolymerunitsderivedfrom
oneormoreofthemonomersbutylacrylate,ethylacrylate,ethylmethacrylate,methyl
acrylate,methylmethacrylate,andnpropylmethacrylateandshallcontainnotmorethan
5weightpercentoftotalpolymerunitsderivedfromacrylicacid,fumaricacid,glycidyl
methacrylate,nhexylmethacrylate,itaconicacid,andmethacrylicacid.Theprovision
limitingthefinishedacryliccopolymerstonotmorethan5unitsderivedfromacrylic
acid,fumaricacid,glycidylmethacrylate,nhexylmethacrylate,itaconicacid,and
methacrylicacidisnotapplicabletofinishedacryliccopolymersusedascoating
adjuvantsatalevelnotexceeding2weightpercentoftotalcoatingsolids
Foruseonly:1.As
emulsifiersforvinylidene
chloridecopolymer
coatingsandlimitedto
useatlevelsnotto
ofthecoatingsolids.2.
Asemulsifiersfor
vinylidenechloride
copolymerorhomopolymer
coatingsatlevelsnotto
exceedatotalof2.6
Alkylmonoanddisulfonicacids,sodiumsalts(producedfromnalkanesintherangeof
percentbyweightof
C10C18withnotlessthan50percentC14C16).
coatingsolids.The
finishedpolymercontacts
foodonlyoftypes
1,underTypesI,II,III,
IV,V,VIA,VIB,VII,
VIII,andIXandunder
conditionsofuseE,F,
andGdescribedintable2
section.
2Bromo4'hydroxyacetophenone
Butanedioicacid,sulfo1,4di(C9C11alkyl)ester,ammoniumsalt(alsoknownas
butanedioicacid,sulfo1,4diisodecylester,ammoniumsalt[CASReg.No.144093889]).
Butylbenzylphthalate
Foruseonlyasa
preservativeforcoating
formulations,binders,
pigmentslurries,and
sizingsolutionsata
levelnottoexceed0.006
coating,solution,slurry
oremulsion.
Foruseasasurface
activeagentinpackage
coatinginksatlevelsnot
toexceed3percentby
weightofthecoatingink.
thischapter.
Butyloleate,sulfated,ammonium,potassium,orsodiumsalt
Butyraldehyde
Captan(Ntrichloromethylmercapto4cyclohexene1,2dicarboximide)
Foruseonlyasamold
andmildewproofingagent
incoatingsintendedfor
useincontactwithfood
onlyofthetypes
19/30
4/8/2015
CastorOil,polyoxyethylated(42molesethyleneoxide)
1(3Chloroallyl)3,5,7triaza1azoniaadamantanechloride(CASReg.No.4080313)
5Chloro2methyl4isothiazolin3one(CASReg.No.26172554)and2methyl4
isothiazolin3one(CASReg.No.2682204)mixtureataratioof3partsto1part,
manufacturedfrommethyl3mercaptopropionate(CASReg.No.2935902).Themixturemay
containmagnesiumnitrate(CASReg.No.10377603)ataconcentrationequivalenttothe
isothiazoloneactiveingredients(weight/weight)
Copper8quinolinolate
1,underTypeI,II,VIB,
andVIII.
Foruseonlyasan
emulsifierin
nitrocellulosecoatings
intendedforusein
paragraph(c)ofthis
TypesIVA,V,VIIA,
VIII,andIXandlimited
touseatalevelnotto
ofthecoatingsolids.
Foruseonly:1.Asa
preservativeatalevelof
0.3weightpercentin
latexesusedaspigment
bindersinpaperand
useincontactwith
nonacidic,nonalcoholic
foodandunderthe
conditionsofuse
conditionsofuseE,F,
andG.2.Asa
preservativeatalevel
nottoexceed0.07weight
percentinlatexesand
0.05weightpercentin
pigmentslurriesusedas
componentsofcoatingsfor
paperandpaperboard
intendedforusein
contactwithfood.
Foruseonly:1.Asan
antimicrobialagentfor
polymerlatexemulsionsin
papercoatingsatalevel
nottoexceed50partsper
million(basedon
isothiazoloneactive
ingredients)inthe
coatingformulation.2.As
anantimicrobialagentfor
finishedcoating
formulationsandfor
additivesusedinthe
paperboardincluding
fillers,binders,pigment
slurries,andsizing
solutionsatalevelnot
toexceed25partsper
million(basedon
isothiazoloneactive
ingredients)inthe
coatingformulationsand
additives.
Foruseonlyas
formulations.
Cyclizedrubberproducedwhennaturalpalecreperubberdissolvedinphenolis
catalyticallycyclizedsothatthefinishedcyclizedrubberhasameltingpointof145
deg.Cto155deg.CasdeterminedbyASTMmethodE2867(Reapproved1982),"StandardTest
MethodforSofteningPointbyRingandBallApparatus,"whichisincorporatedbyreference
(CopiesmaybeobtainedfromtheAmericanSocietyforTestingMaterials,100BarrHarbor Foruseonlyincoatings
Dr.,WestConshohocken,Philadelphia,PA194282959,ormaybeexaminedattheNational
ArchivesandRecordsAdministration(NARA).Forinformationontheavailabilityofthis
intendedforusein
materialatNARA,call2027416030,orgoto:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.), thetypesidentifiedin
andcontainsnomorethan4000ppmofresidualfreephenolasdeterminedbyagasliquid paragraph(c)ofthis
chromatographicproceduretitled"DeterminationofFreePhenolinCyclizedRubberResin," section,table1,under
whichisincorporatedbyreference.CopiesareavailablefromtheCenterforFoodSafety TypesVIIIandIX.
andAppliedNutrition(HFS200),FoodandDrugAdministration,5100PaintBranchPkwy.,
CollegePark,MD20740,oravailableforinspectionattheNationalArchivesandRecords
Administration(NARA).ForinformationontheavailabilityofthismaterialatNARA,call
2027416030,orgoto:
Foruseonlyasa
20/30
4/8/2015
1,2Dibromo2,4dicyanobutane(CASReg.No.35691657)
preservativeatlevelsnot
morethan0.05weight
percentandnotlessthan
0.01weightpercent:in
latexesusedaspigment
bindersincoatingsin
pigmentslurriesusedin
coatingsand/orin
coatingsthemselves.The
totallevelofthe
preservativeinthe
finishedcoatingshallnot
exceed0.04weightpercent
ofthefinishedcoating
solids.
Dibutylphthalate
Dibutylsebacate
Di(C7,C9alkyl)adipate
thischapter.
Dicyclohexylphthalate
Diethyleneglycoldibenzoate(CASReg.No.120558)
Foruseonlyasa
plasticizerforpolyvinyl
acetatecoatingsata
levelnottoexceed5
coatingsolidsunder
conditionsdescribedin
paragraph(c)ofthis
section,table2,
conditionsofuseE,F,
andG.
Diethyleneglycolesteroftheadductofterpeneandmaleicanhydride
Dihydroxydichlorodiphenylmethane
Foruseonlyas
formulations.
Dimethylpolysiloxane,100centistokesviscosity
Dimethylpolysiloxanebetaphenylethylmethylpolysiloxanecopolymer(2:1),200to400
centistokesviscosity
N,N'Diphenylpphenylenediamine
Dipropyleneglycoldibenzoate(CASReg.No.27138314)
DisodiumNoctadecylsulfosuccinamate
Foruseonlyas
polymerizationinhibitor
in2sulfoethyl
methacrylate,sodiumsalt.
1.Foruseonlyasa
plasticizerforpolyvinyl
acetatecoatingsata
levelnottoexceed5
coatingsolidsunder
conditionsdescribedin
paragraph(c)ofthis
section,table2,
conditionofuseE.2.For
useonlyasaplasticizer
forpolyvinylacetate
exceed10percentby
weightofthecoating
solidsunderconditions
conditionsofuseFandG.
Foruseonlyasan
emulsifierinresinlatex
coatingsandlimitedto
useatalevelnotto
exceed0.05%byweightof
thecoatingsolids.
EDTA(ethylenediaminetetraaceticacid)anditssodiumand/orcalciumsalts
Ethanedial,polymerwithtetrahydro4hydroxy5methyl2(1H)pyrimidinone,propoxylated
(CASReg.No.118299904)
Foruseonlyasan
insolubilizerforstarch
basedcoatingsandlimited
touseatalevelnotto
exceed5.0percentby
weightofthecoating.
Ethyleneacrylicacidcopolymersproducedbythecopolymerizationofethyleneandacrylic
acidand/ortheirpartialammoniumsalts.Thefinishedcopolymershallcontainnomore
than25weightpercentofpolymerunitsderivedfromacrylicacidandnomorethan0.35
weightpercentofresidualmonomericacrylicacid,andhaveameltindexnottoexceed350
asdeterminedbyASTMmethodD123882,"StandardTestMethodforFlowRatesof
ThermoplasticsbyExtrusionPlastometer,"whichisincorporatedbyreference.Copiesmay
beobtainedfromtheAmericanSocietyforTestingMaterials,100BarrHarborDr.,West
Conshohocken,Philadelphia,PA194282959,ormaybeexaminedattheNationalArchivesand
RecordsAdministration(NARA).Forinformationontheavailabilityofthismaterialat
NARA,call2027416030,orgoto:
21/30
4/8/2015
Formaldehyde
Glyoxal
Foruseonlyas
formulations.
Foruseonlyasan
insolubilizingagentin
starchandproteinbased
coatingsthatcontact
nonalcoholicfoods,and
weightofthestarchor
proteinfractionofthe
coatingsolids.
Glycerylmonobutylricinoleate
Foruseonlyasa
comonomerinpolyvinyl
Hydroxymethylderivatives(mixtureofmonoandpoly)of[N(1,1dimethyl3oxobutyl)
acetatelatexcoatingsand
acrylamide]producedbyreacting1moleofthe[N(1,1dimethyl3oxobutyl)acrylamide]
with3molesofformaldehydesuchthatthefinishedproducthasamaximumnitrogencontent
of6.2percentandamaximumhydroxylcontentof15percentbyweightonadrybasis
weightofdrypolymer
solids.
Isobutyloleate,sulfated,ammonium,potassium,orsodiumsalt
Maleicanhydrideadductofbutadienestyrenecopolymer
[alpha]Methylstyrenevinyltoluenecopolymerresins(molarratio1[alpha]methylstyreneto
3vinyltoluene)
Foruseonlyasa
componentofcoatingsin
paperandpaperboard
productsatalevelnotto
Modifiedkaolinclay(CASReg.No.1344009)isproducedbythereactionofsodium
ofthecoatingintended
silicate(CASReg.No.1344098)andkaoliniteclay(CASReg.No.1332587)under
hydrothermalconditions.Thereactionproducthasamolecularweightbetween246and365 foruseincontactwith
andconsistsof46to55percentsilicondioxide(Si02),28to42percentaluminumoxide foodofTypesIthroughIX
describedintable1of
(A1203),and2to7percentofsodiumoxide(Na20).Thereactionproductwillnotconsist
paragraph(c)ofthis
ofmorethan70percentmodifiedkaolinclay
ofuseCthroughH
describedintable2of
paragraph(c)ofthis
section.
Naphthalenesulfonicacidformaldehydecondensate,sodiumsalt
Oleylalcohol
Oxazolidinylethylmethacrylate(CASRegistryNo.46236151)copolymerwithethylacrylate Foruseonlyasabinder
andmethylmethacrylate,andcontainingnotmorethan6percentbyweightof
forpigmentcoatingsasa
oxazolidinylethylmethacrylate.Maximumnitrogencontentshallbe0.5percentandnumber
binderlevelnottoexceed
averagemolecularweightofthatportionofthecopolymersolubleintetrahydrofuranshall 4.0percentbyweightof
benotlessthan50,000
drypaperorpaperboard.
Pentaerythritoltetrastearate
Petroleumalicyclichydrocarbonresins,orthehydrogenatedproductthereof,meetingthe
followingspecifications:Softeningpoint97deg.Cminimum,asdeterminedbyASTMmethod
E2867(Reapproved1982),"StandardTestMethodforSofteningPointbyRingandBall
Apparatus"anilinepoint120deg.Cminimum,asdeterminedbyASTMmethodD61182,
Foruseonlyasmodifiers
"StandardTestMethodsforAnilinePointandMixedAnilinePointofPetroleumProductsand
inwaxpolymerblend
HydrocarbonSolvents,"whichareincorporatedbyreference(Copiesmaybeobtainedfrom
coatingsforcorrugated
theAmericanSocietyforTestingMaterials,100BarrHarborDr.,WestConshohocken,
Philadelphia,PA194282959,ormaybeexaminedattheNationalArchivesandRecords
useinbulkpackagingor
Administration(NARA).ForinformationontheavailabilityofthismaterialatNARA,call
rawfruits,raw
2027416030,orgoto:
vegetables,icedmeat,
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.).
icedfish,andiced
Specificgravity0.960.99(20deg.C/20deg.C).Suchpetroleumhydrocarbonresinsare
poultryandlimitedto
producedbythecatalyticpolymerizationofdienesandolefinsfromlowboiling
useatalevelnotto
distillatesofcrackedpetroleumstocksthatcontainnomaterialboilingover200deg.C
exceed30weightpercent
andthatmeettheultravioletabsorbancelimitsprescribedin172.880(b)ofthischapter
ofthecoatingsolids.
whensubjectedtotheanalyticalproceduredescribedin172.886(b)ofthischapter,
modifiedasfollows:Treattheproductasinthefirstparagraphunder"Procedure"in
172.250(b)(3)ofthischapter.Thenproceedwith172.886(b)ofthischapter,startingwith
theparagraphcommencingwith"Promptlycompletetransferofthesample***"
Polyesterresinformedbythereactionofthemethylesterofrosin,phthalicanhydride,
maleicanhydrideandethyleneglycol,suchthatthepolyesterresinhasanacidnumberof
4to11,adropsofteningpointof70deg.C92deg.C.,andacolorofKorpaler
Polyesterresinproducedbyreactingtheacidgroupsinmontanwaxwithethyleneglycol
Polyethylene,oxidized
thischapter.
Polyethylenereactedwithmaleicanhydridesuchthatthemodifiedpolyethylenehasa
saponificationnumbernotinexcessof6afterSoxhletextractionfor24hourswith
anhydrousethylalcohol
Nottoexceed300p.p.m.
Polyoxyethylated(40moles)tallowalcoholsulfate,sodiumsalt
infinishedcoatedpaper
orpaperboard.
Polyoxypropylenepolyoxyethyleneblockpolymers(minimummolecularweight6,800)
Polyvinylacetate
Polyvinylalcohol(minimumviscosityof4%aqueoussolutionat20deg.C.of4
centipoises)
Polyvinylbutyral
22/30
4/8/2015
Polyvinylformal
Polyvinylidenechloride
Polyvinylpyrrolidone
Polyvinylstearate
Propyleneglycolmonoanddiestersoffatsandfattyacids
coating.Platinumcontent
nottoexceed200parts
permillion.1.In
coatingsforpaperand
paperboardprovidedthe
coatingcontactsfoodonly
ofthetypesidentifiedin
paragraph(c)ofthis
TypesI,II,VI,andVIIB
Siloxanesandsiliconesplatinumcatalyzedreactionproductofvinylcontainingdimethyl whenusedunderconditions
polysiloxane(CASReg.Nos.68083192and68083181)withmethylhydrogenpolysiloxane ofuseE,F,andG
(CASReg.No.63148572)ordimethyl(methylhydrogen)polysiloxane(CASReg.No.68037 describedintable2of
592).Diallylmaleate(CASRegNo.999213),dimethylmaleate(CASReg.No.624486), paragraph(c)ofthis
1ethynyl1cyclohexanol(CASReg.No.78273)andvinylacetate(CASReg.No.108054) section.2.Incoatings
maybeusedasoptionalpolymerizationinhibitors
providedthecoating
contactsfoodonlyofthe
typesidentifiedin
paragraph(c)ofthis
TypesIII,IV,V,VIIA,
VIII,andIXwhenused
underconditionsofuseA
throughHdescribedin
ofthissection.
Siloxanesandsiliconesplatinumcatalyzedreactionproductofvinylcontaining
Platinumcontentnotto
dimethylpolysiloxane(CASReg.Nos.68083192and68083181),withmethylhydrogen
exceed100partsper
polysiloxane(CASReg.No.63148572).Dimethylmaleate(CASReg.No.624486),vinyl
million.Foruseonlyasa
acetate(CASReg.No.108054),dibutylmaleate(CASReg.No.105760)anddiallyl
releasecoatingfor
maleate(CASReg.No.999213)maybeusedasoptionalpolymerizationinhibitors.The
pressuresensitive
polymermayalsocontainC16C18olefins(CASReg.No.68855607)asacontrolrelease
adhesives.
agent
Sodiumdecylbenzenesulfonate
Sodiumdihexylsulfosuccinate
Foruseonlyasan
emulsifierincoatings
thatcontactfoodonlyof
paragraph(c)ofthis
Sodiumndodecylpolyethoxy(50moles)sulfatesodiumisododecylphenoxypolyethoxy(40
moles)sulfatemixtures
TypesIVA,V,VII,VIII,
andIXandlimitedtouse
atlevelsnottoexceed
thecoatingsolids.
Sodium2ethylhexylsulfate
Sodiumoleoylisopropanolamidesulfosuccinate
Sodiumpentachlorophenate
Sodiumophenylphenate
Sodiumvinylsulfonatepolymerized
Foruseonlyas
formulations.
Do.
Foruseonlyinpaperand
paperboardcoatingsat
levelsnottoexceed0.01
Sodiumxylenesulfonate(CASReg.No.1300727)
finishedpaperand
paperboard.
orcomponentofcoatings
Styrenecopolymersproducedbycopolymerizingstyrenewithmaleicanhydrideanditsmethyl
andlimitedtouseata
andbutyl(secoriso)esters.Suchcopolymersmaycontain[beta]nitrostyreneasa
polymerizationchainterminator
weightofpaperor
paperboardsubstrate.
Foruseonlyincontact
Styrenepolymersmadebythepolymerizationofanycombinationofstyreneoralphamethyl withfoodsofTypesIVA,
styrenewithacrylicacid,methacrylicacid,2ethylhexylacrylate,methylmethacrylate, V,andVIIintable1of
paragraph(c)ofthis
andbutylacrylate.Thestyreneandalphamethylstyrene,individually,mayconstitute
from0to80weightpercentofthepolymer.Theothermonomers,individually,maybefrom section,underuse
conditionsEthroughGin
0to40weightpercentofthepolymer.Thepolymernumberaveragemolecularweight(Mn)
table2ofparagraph(c),
shallbeatleast2,000(asdeterminedbygelpermeationchromatography).Theacidnumber
andwithfoodsofTypes
ofthepolymershallbelessthan250.Themonomercontentshallbelessthan0.5percent
VIIIandIXwithoutuse
temperaturerestriction.
Styreneacryliccopolymers(CASReg.No.25950407producedbypolymerizing77to83
Foruseonlyasa
partsbyweightofstyrenewith13to17partsofmethylmethacrylate,3to4partsof
componentofcoatingsand
23/30
4/8/2015
butylmethacrylate,0.5to2.5partsofmethacrylicacid,and0.1to0.3partofbutyl
acrylatesuchthatthefinishedcopolymershaveaminimumnumberaveragemolecularweight nottoexceed20percent
greaterthan100,000andalevelofresidualstyrenemonomerinthepolymernottoexceed byweightofthecoating
0.1percentbyweight
solids.
Styrenebutadienecopolymersproducedbycopolymerizingstyrenebutadienewithoneormore
ofthemonomer:acrylamide,acrylicacid,fumaricacid,2hydroxyethylacrylate,itaconic
acid,andmethacrylicacid.Thefinishedcopolymersshallcontainnotmorethan10weight
percentoftotalpolymerunitsderivedfromacrylicacid,fumaricacid,2hydroxyethyl
acrylate,itaconicacidandmethacrylicacid,andshallcontainnotmorethan2weight
percentofpolymerunitsderivedfromacrylamide
Styrenebutadienecopolymerswith2hydroxyethylacrylateandacrylicacidcontainingnot
morethan15weightpercentacrylicacidandnomorethan20weightpercentofa
combinationof2hydroxyethylacrylateandacrylicacid
Styrenebutadienevinylidenechloridecopolymerscontainingnotmorethan40weight
percentofvinylidenechlorideinthefinishedcopolymers.Thefinishedcopolymersmay
containnotmorethan10weightpercentoftotalpolymerunitsderivedfromacrylicacid, orcomponentsofcoatings.
fumaricacid,2hydroxyethylacrylate,itaconicacid,and/ormethacrylicacid
Styrenedimethylstyrene[alpha]methylstyrenecopolymersproducedbypolymerizing
equimolarratiosofthethreecomonomerssuchthatthefinishedcopolymershaveaminimum Foruseonlyincoatings
averagemolecularweightof835asdeterminedbyASTMmethodD250382,"StandardTest
intendedforusein
MethodforMolecularWeight(RelativeMolecularMass)ofHydrocarbonsbyThermoelectric
MeasurementofVaporPressure,"whichisincorporatedbyreference.Copiesmaybeobtained contactwithnonfattyfood
fromtheAmericanSocietyforTestingMaterials,100BarrHarborDr.,WestConshohocken, andlimitedtouseata
Philadelphia,PA194282959,ormaybeexaminedattheNationalArchivesandRecords
Administration(NARA).ForinformationontheavailabilityofthismaterialatNARA,call weightofthecoating
solids.
2027416030,orgoto:
Styreneisobutylenecopolymers(weightaveragemolecularweightnotlessthan6,300)
intendedforusein
contactunderconditions
ofuseDGdescribedin
ofthissection,withfood
ofTypesI,II,IVB,VI
B,VIIB,andVIII
describedintable1of
paragraph(c)ofthis
sectionandlimitedto
useatalevelnotto
exceed40percentby
weightofthecoating
solids.
Styrenemaleicanhydridecopolymers
orcomponentofcoatings
andlimitedforuseata
levelnottoexceed2
percentbyweightofpaper
orpaperboardsubstrate.
Styrenemethacrylicacidcopolymerscontainingnomorethan5weightpercentofpolymer
unitsderivedfrommethacrylicacid
Styrenevinylidenechloridecopolymerscontainingnotmorethan40weightpercentof
vinylidenechlorideinthefinishedcopolymers.Thefinishedcopolymersmaycontainnot
morethan5weightpercentoftotalpolymerunitsderivedfromacrylicacid,fumaricacid, orcomponentsofcoatings.
itaconicacid,and/ormethacrylicacid
Foruseonlyincopolymer
coatingsunderconditions
ofuseE,F,andG
2Sulfoethylmethacrylate,sodiumsalt[ChemicalAbstractsServiceNo.1804871]
andlimitedtouseata
levelnottoexceed2.0
drycopolymercoating.
activeagentatlevelsnot
toexceed3percentby
weightofvinylacetate
polymerwithethyleneand
N(hydroxymethyl)
acrylamideintendedfor
useincoatingsforpaper
andpaperboardintended
foruseincontactwith
foods:1.Ofthetypes
[alpha]<[em>p(1,1,3,3Tetramethylbutyl)phenyl]omegahydroxypoly(oxyethylene)hydrogen 1,underTypesI,II,III,
sulfate,sodiumsaltmixturewith[alpha]<[em>p(1,1,3,3tetramethylbutyl)phenyl]omega IV,VIB,andVII,and
hydroxypoly(oxyethylene)withbothsubstanceshavingapoly(oxyethylene)content
undertheconditionsof
averaging3moles
usedescribedinparagraph
2,conditionsofuseE,F,
andG.2.Ofthetypes
24/30
4/8/2015
1,underTypesV,VIIIand
IXandunderthe
conditionsofuse
conditionsofuseC,D,E,
F,andG.
TetrasodiumN(1,2dicarboxyethyl)Noctadecylsulfosuccinamate
Foruseonlyasan
emulsifierinresinlatex
coatings,andlimitedto
useatalevelnotto
exceed0.05%byweightof
thecoatingsolids.
Toluenesulfonamideformaldehyderesins
Vinylacetatecopolymersproducedbycopolymerizingvinylacetatewithoneormoreofthe
monomersacrylamide,acrylicacid,acrylonitrile,bicyclo[2.2.1]hept2ene6
methylacrylate,butylacrylate,crotonicacid,decylacrylate,diallylfumarate,diallyl
maleate,diallylphthalate,dibutylfumarate,dibutylitaconate,dibutylmaleate,di(2
ethylhexyl)maleate,divinylbenzene,ethylacrylate,2ethylhexylacrylate,fumaric
acid,itaconicacid,maleicacid,methacrylicacid,methylacrylate,methylmethacrylate,
mono(2ethylhexyl)maleate,monoethylmaleate,styrene,vinylbutyrate,vinylcrotonate,
vinylhexoate,vinylidenechloride,vinylpelargonate,vinylpropionate,vinyl
pyrrolidone,vinylstearate,andvinylsulfonicacid.Thefinishedcopolymersshall
containatleast50weightpercentofpolymerunitsderivedfromvinylacetateandshall
containnomorethan5weightpercentoftotalpolymerunitsderivedfromacrylamide,
acrylicacid,crotonicacid,decylacrylate,dibutylitaconate,di(2ethylhexyl)maleate,
fumaricacid,itaconicacid,maleicacid,methacrylicacid,mono(2ethylhexyl)maleate,
monoethylmaleate,vinylbutyrate,vinylhexoate,vinylpelargonate,vinylpropionate,
vinylstearate,andvinylsulfonicacid
VinylacetatepolymerwithethyleneandN(hydroxymethyl)acrylamidecontainingnotmore
than6weightpercentoftotalpolymerunitsderivedfromN(hydroxymethyl)acrylamide
intendedforusein
contactwithfoods:1.Of
paragraph(c)ofthis
TypesI,II,III,IV,VI
B,andVIIandunderthe
conditionsofuse
conditionsofuseE,F,
andG.2.Ofthetypes
1,underTypesV,VIII,
andIXandunderthe
conditionsofuse
conditionsofuseC,D,E,
F,andG.
Vinylchloridecopolymersproducedbycopolymerizingvinylchloridewithoneormoreof
themonomersacrylonitrilefumaricacidanditsmethyl,ethyl,propyl,butyl,amyl,
hexyl,heptyl,oroctylestersmaleicacidanditsmethyl,ethyl,propyl,butyl,amyl,
hexyl,heptyl,oroctylestersmaleicanhydride5norbornene2,3dicarboxylicacid,
mononbutylestervinylacetateandvinylidenechloride.Thefinishedcopolymersshall
containatleast50weightpercentofpolymerunitsderivedfromvinylchloride:shall
containnomorethan5weightpercentoftotalpolymerunitsderivedfromfumaricand/or
maleicacidand/ortheirmethyl,ethyl,propyl,butyl,amyl,heptyl,oroctylmonoesters
orfrommaleicanhydrideorfrommononbutylesterof5norbornene2,3dicarboxylicacid
(however,inanycasethefinishedcopolymersshallcontainnomorethan4weightpercent
oftotalpolymerunitsderivedfrommononbutylesterof5norbornene2,3dicarboxylic
acid)
Vinylchloridevinylacetatehydroxylmodifiedcopolymers
Vinylchloridevinylacetatehydroxylmodifiedcopolymersreactedwithtrimellitic
anhydride
Vinylidenechloridecopolymersproducedbycopolymerizingvinylidenechloridewithoneor
moreofthemonomersacrylamideacrylicacid,acrylonitrile,butylacrylate,butyl
methacrylateethylacrylate,ethylmethacrylate,fumaricacid,itaconicacid,methacrylic
acid,methylacrylate,methylmethacrylate,octadecylmethacrylate,propylacrylate,
propylmethacrylate,vinylchlorideandvinylsulfonicacid.Thefinishedcopolymersshall
containatleast50weightpercentofpolymerunitsderivedfromvinylidenechlorideand
shallcontainnomorethan5weightpercentoftotalpolymerunitsderivedfrom
acrylamide,acrylicacid,fumaricacid,itaconicacid,methacrylicacid,octadecyl
methacrylate,andvinylsulfonicacid
Colorants:
Aluminum
Aluminumhydrate
Aluminumandpotassiumsilicate(mica)
Aluminummono,di,andtristearate
Aluminumsilicate(Chinaclay)
Foruseasacolorant
only.
Do.
Do.
Do.
Do.
25/30
4/8/2015
Bariumsulfate
Bentonite
Bentonite,modifiedwithdimethyldioctadecylammoniumion
Burntumber
Calciumcarbonate
Calciumsilicate
Calciumsulfate
Carbonblack(channelprocess)
Cobaltaluminate
Diatomaceousearth
Ironoxides
Magnesiumoxide
Magnesiumsilicate(talc)
Phthalocyanineblue(C.I.pigmentblue15,15:1,15:2,15:3,and15:4C.I.No.74160
CASReg.No.147148)
Rawsienna
Silica
Tartrazinelake(certifiedFD+CYellowNo.5only)
Titaniumdioxide
Titaniumdioxidebariumsulfate
Titaniumdioxidemagnesium
silicate
Zinccarbonate
Zincoxide
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
(c)Thefoodcontactsurfaceofthepaperandpaperboardinthefinishedforminwhichitistocontactfood,when
extractedwiththesolventorsolventscharacterizingthetypeoffood,andunderconditionsoftimeandtemperature
characterizingtheconditionsofitsintendeduseasdeterminedfromtables1and2ofthisparagraph,shallyield
netchloroformsolubleextractives(correctedforwax,petrolatum,mineraloilandzincextractivesaszincoleate)
nottoexceed0.5milligrampersquareinchoffoodcontactsurfaceasdeterminedbythemethodsdescribedin
paragraph(d)ofthissection.
Table1TypesofRawandProcessedFoods
I.Nonacid,aqueousproductsmaycontainsaltorsugarorboth(pHabove5.0).
II.Acid,aqueousproductsmaycontainsaltorsugarorboth,andincludingoilinwateremulsionsofloworhigh
fatcontent.
III.Aqueous,acidornonacidproductscontainingfreeoilorfatmaycontainsalt,andincludingwaterinoil
emulsionsofloworhighfatcontent.
IV.Dairyproductsandmodifications:
A.Waterinoilemulsions,highorlowfat.
B.Oilinwateremulsions,highorlowfat.
V.Lowmoisturefatsandoil.
VI.Beverages:
A.Containingupto8percentofalcohol.
B.Nonalcoholic.
C.Containingmorethan8percentalcohol.
VII.BakeryproductsotherthanthoseincludedunderTypesVIIIorIXofthistable:
A.Moistbakeryproductswithsurfacecontainingfreefatoroil.
B.Moistbakeryproductswithsurfacecontainingnofreefatoroil.
VIII.Drysolidswiththesurfacecontainingnofreefatoroil(noendtestrequired).
IX.Drysolidswiththesurfacecontainingfreefatoroil.
Table2TestProcedureswithTimeTemperatureConditionsforDeterminingAmountofExtractivesFromtheFood
ContactSurfaceofUncoatedorCoatedPaperandPaperboard,UsingSolventsSimulatingTypesofFoodsandBeverages
Foodsimulatingsolvents
8percent 50percent
Typesoffood
Water
Heptane1
Conditionofuse
alcohol
alcohol
(seetable1)
Timeand
Timeand
Timeand
Timeand
temperature
temperature temperature temperature
A.Hightemperatureheatsterilized(e.g.,over212 I,IVB,VII
250deg.F,2hr
deg.F)
B
III,IVA,
150deg.F,
......do
VIIA
2hr
212deg.F,30
B.Boilingwatersterilized
II,VIIB
min
120deg.F,
III,VIIA
......do
30min
Fillboiling,
II,IVB,
C.Hotfilledorpasteurizedabove150deg.F
coolto100deg.
VIIB
F
III,IVA,
120deg.F,
......do
VIIA
15min
V,IX
......do
II,IVB,VI
D.Hotfilledorpasteurizedbelow150deg.F
B,
VIIB
150deg.F,2hr
III,IVA,
100deg.F,
......do
VIIA
30min
V,IX
......do
26/30
4/8/2015
VIA
150deg.F,
2hr
150deg.F,
2hr.
VIC
E.Roomtemperaturefilledandstored(nothermal
treatmentinthecontainer)
I,II,IVB, 120deg.F,24
VIB,VIIB
hr
III,IVA,
......do
VIIA
V,IX
70deg.F,
30min
......do
120deg.F,
24hr
VIA
120deg.F,
24hr.
VIC
F.Refrigeratedstorage(nothermaltreatmentinthe III,IVA,
70deg.F,
70deg.F,48hr
container)
VIIA
30min
I,II,IVB,
......do
VIB,VIIB
70deg.F,
48hr
VIA
70deg.F,
48hr.
VIC
G.Frozenstorage(nothermaltreatmentinthe
container)
I,II,IVB,
70deg.F,24hr
VIIB
III,VIIA
......do
70deg.F,
30min
H.Frozenorrefrigeratedstorage:Readyprepared
foodsintendedtobereheatedincontainerattimeof
use:
1.Aqueousoroilinwateremulsionofhighor
lowfat
2.Aqueous,highorlowfreeoilorfat
I,II,IVB, 212deg.F,30
VIIB
min
III,IVA,
......do
VIIA,IX
120deg.F,
30min
1Heptaneextractabilityresultsmustbedividedbyafactoroffiveinarrivingattheextractabilityforafood
producthavingwaterinoilemulsionorfreeoilorfat.Heptanefoodsimulatingsolventisnotrequiredinthecase
ofwaxpolymerblendcoatingsforcorrugatedpaperboardcontainersintendedforuseinbulkpackagingoficedmeat,
icedfish,andicedpoultry.
(d)Analyticalmethods(1)Selectionofextractabilityconditions.Firstascertainthetypeoffoodproduct(table
1,paragraph(c)ofthissection)thatisbeingpackedcommerciallyinthepaperorpaperboardandthenormal
conditionsofthermaltreatmentusedinpackagingthetypeoffoodinvolved.Usingtable2,paragraph(c)ofthis
section,selectthefoodsimulatingsolventorsolventsandthetimetemperatureexaggerationsofthepaperor
paperboarduseconditions.Havingselectedtheappropriatefoodsimulatingsolventorsolventsandthetime
temperatureexaggerationovernormaluse,followtheapplicableextractionprocedure.
(2)Reagents(i)Water.Allwaterusedinextractionproceduresshouldbefreshlydemineralized(deionized)
distilledwater.
(ii)nHeptane.Reagentgrade,freshlyredistilledbeforeuse,usingonlymaterialboilingat208deg.F.
(iii)Alcohol.8or50percent(byvolume),preparedfromundenatured95percentethylalcoholdilutedwith
demineralized(deionized)distilledwater.
(iv)Chloroform.Reagentgrade,freshlyredistilledbeforeuse,oragradehavinganestablishedconsistentlylow
blank.
(3)Selectionoftestmethod.Paperorpaperboardreadyforuseinpackagingshallbetestedbyuseofthe
extractioncelldescribedin"OfficialMethodsofAnalysisoftheAssociationofOfficialAnalyticalChemists,"13th
Ed.(1980),sections21.01021.015,under"ExposingFlexibleBarrierMaterialsforExtraction,"whichis
incorporatedbyreference(CopiesmaybeobtainedfromtheAOACINTERNATIONAL,481NorthFrederickAve.,suite500,
Gaithersburg,MD20877,ormaybeexaminedattheNationalArchivesandRecordsAdministration(NARA).For
informationontheavailabilityofthismaterialatNARA,call2027416030,orgoto:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.)alsodescribedinASTM
methodF3476(Reapproved1980),"StandardTestMethodforLiquidExtractionofFlexibleBarrierMaterials,"which
isincorporatedbyreference(copiesmaybeobtainedfromtheAmericanSocietyforTestingMaterials,100Barr
HarborDr.,WestConshohocken,Philadelphia,PA194282959,ormaybeexaminedattheNationalArchivesandRecords
Administration(NARA).ForinformationontheavailabilityofthismaterialatNARA,call2027416030,orgoto:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.),exceptthatformedpaper
andpaperboardproductsmaybetestedinthecontainerbyadaptingtheincontainermethodsdescribedin175.300(e)
ofthischapter.Formedpaperandpaperboardproductssuchascontainersandlids,thatcannotbetested
satisfactorilybyanyoftheabovemethodsmaybetestedinspeciallydesignedextractionequipment,usually
consistingofclampingdevicesthatfittheclosureorcontainersothatthefoodcontactsurfacecanbetested,or,
ifflatsamplescanbecutfromtheformedpaperorpaperboardproductswithoutdestroyingtheintegrityofthe
foodcontactsurface,theymaybetestedbyadaptingthefollowing"sandwich"method:
(i)Apparatus.(a)Thermostated(+/1.0deg.F)waterbath,variablebetween70deg.Fand120deg.Fwaterbath
covercapableofholdingatleastone800milliliterbeakerpartiallysubmersedinbath.
(b)Analyticalbalancesensitiveto0.1milligramwithanapproximatecapacityof100grams.
(c)Tongs.
(d)Hoodandhotplatefacilities.
(e)Forceddraftoven.
Foreachextraction,thefollowingadditionalapparatusisnecessary:
(f)OneNo.2paperclip.
(g)One800milliliterbeakerwithwatchglasscover.
(h)One250milliliterbeaker.
27/30
4/8/2015
(i)Five21/2inchsquarealuminumscreens(standardaluminumwindowscreeningisacceptable).
(j)Onewirecapableofsupportingsamplestack.
(ii)Procedure.(a)Foreachextraction,accuratelycuteight21/2inchsquaresamplesfromtheformedpaperor
paperboardproducttobetested.
(b)Carefullystacktheeight21/2inchsquaresamplesandthefive21/2inchsquarealuminumscreensinsandwich
formsuchthatthefoodcontactsideofeachsampleisalwaysnexttoanaluminumscreen,asfollows:Screen,
sample,sample,screen,sample,sample,screen,etc.ClipthesandwichtogethercarefullywithaNo.2paperclip,
leavingjustenoughspaceatthetoptoslipawirethrough.
(c)Placean800milliliterbeakercontaining100millilitersoftheappropriatefoodsimulatingsolventintothe
constanttemperaturebath,coverwithawatchglassandconditionatthedesiredtemperature.
(d)Afterconditioning,carefullylowerthesamplesandwichwithtongsintothebeaker.
(e)Attheendoftheextractionperiod,usingthetongs,carefullyliftoutthesamplesandwichandhangitover
thebeakerwiththewire.
(f)Afterdraining,pourthefoodsimulatingsolventsolutionintoatared250milliliterbeaker.Rinsethe800
milliliterbeakerthreetimes,usingatotalofnotmorethan50millilitersoftherequiredsolvent.
(g)Determinetotalnonvolatileextractivesinaccordancewithparagraph(d)(5)ofthissection.
(4)Selectionofsamples.Quadruplicatesamplesshouldbetested,usingforeachreplicatesamplethenumberof
cups,containers,orpreformedorconvertedproductsnearesttoanareaof100squareinches.
(5)Determinationofamountofextractives(i)Totalresidues.Attheendoftheexposureperiod,removethetest
containerortestcellfromtheovenandcombinethesolventforeachreplicateinacleanPyrex(orequivalent)
flaskorbeakerbeingsuretorinsethetestcontainerorcellwithasmallquantityofcleansolvent.Evaporatethe
foodsimulatingsolventstoabout100millilitersintheflaskorbeaker,andtransfertoaclean,taredevaporating
dish(platinumorPyrex),washingtheflaskthreetimeswithsmallportionsofsolventusedintheextraction
procedure,andevaporatetoafewmillilitersonanonsparking,lowtemperaturehotplate.Thelastfewmilliliters
shouldbeevaporatedinanovenmaintainedatatemperatureofapproximately221deg.F.Cooltheevaporatingdish
inadesiccatorfor30minutesandweightheresiduetothenearest0.1milligram,(e).Calculatetheextractives
inmilligramspersquareinchofthecontainerorsheetedpaperorpaperboardsurface.
(a)Waterand8and50percentalcohol.Milligramsextractivespersquareinch=(e)/(s).
(b)Heptane.Milligramsextractivespersquareinch=(e)/(s)(F)
where:
e=Milligramsextractivespersampletested.
s=Surfaceareatested,insquareinches.
F=Five,theratiooftheamountofextractivesremovedbyheptaneunderexaggeratedtimetemperaturetest
conditionscomparedtotheamountextractedbyafatoroilunderexaggeratedconditionsofthermalsterilization
anduse.
e'=Chloroformsolubleextractivesresidue.
ee'=Correctedchloroformsolubleextractivesresidue.
e'oree'issubstitutedforeintheaboveequationswhennecessary.
Ifwhencalculatedbytheequationsinparagraph(d)(5)(i)(a)and(b)ofthissection,theextractivesin
milligramspersquareinchexceedsthelimitationsprescribedinparagraph(c)ofthissection,proceedtoparagraph
(d)(5)(ii)ofthissection(methodfordeterminingtheamountofchloroformsolubleextractivesresidues).
(ii)Chloroformsolubleextractivesresidue.Add50millilitersofchloroform(freshlydistilledreagentgradeora
gradehavinganestablishedconsistentlylowblank)tothedriedandweighedresidue,(e),intheevaporatingdish
obtainedinparagraph(d)(5)(i)ofthissection.Warmcarefully,andfilterthroughWhatmanNo.41filterpaper(or
equivalent)inaPyrex(orequivalent)funnel,collectingthefiltrateinaclean,taredevaporatingdish(platinum
orPyrex).Repeatthechloroformextraction,washingthefilterpaperwiththissecondportionofchloroform.Add
thisfiltratetotheoriginalfiltrateandevaporatethetotaldowntoafewmillilitersonalowtemperature
hotplate.Thelastfewmillilitersshouldbeevaporatedinanovenmaintainedatapproximately221deg.F.Coolthe
evaporatingdishinadesiccatorfor30minutesandweightothenearest0.1milligramtogetthechloroformsoluble
extractivesresidue(').This'issubstitutedforeintheequationsinparagraph(d)(5)(i)(a)and(b)ofthis
section.Ifthechloroformsolubleextractivesinmilligramspersquareinchstillexceedsthelimitationprescribed
inparagraph(c)ofthissection,proceedtoparagraph(d)(5)(iii)ofthissection(methodfordeterminingcorrected
chloroformsolubleextractivesresidue).
(iii)Correctedchloroformsolubleextractivesresidue(a)Correctionforzincextractives.Ashtheresiduein
theevaporatingdishbyheatinggentlyoveraMekertypeburnertodestroyorganicmatterandholdatredheatfor
about1minute.Coolintheairfor3minutes,andplacetheevaporatingdishinthedesiccatorfor30minutesand
weightothenearest0.1milligram.AnalyzethisashforzincbystandardAssociationofOfficialAgricultural
Chemistsmethodsorequivalent.Calculatethezincintheashaszincoleate,andsubtractfromtheweightof
chloroformsolubleextractivesresidue(')toobtainthezinccorrectedchloroformsolubleextractivesresidue(e'
).Thise'issubstitutedforeintheequationsinparagraph(d)(5)(i)(a)and(b)ofthissection.
(b)Correctionforwax,petrolatum,andmineraloil(1)Apparatus.Standard10millimeterinsidediameter*60
centimeterchromatographiccolumn(orstandard50milliliterburetwithaninsidediameterof1011millimeters)
withastopcockofglass,perfluorocarbonresin,orequivalentmaterial.Thecolumn(orburet)maybeoptionally
equippedwithanintegralcoarse,frittedglassdiscandthetopofthecolumn(orburet)maybeoptionallyfitted
witha100millimetersolventreservoir.
(2)Preparationofcolumn.Placeasnugpledgetoffineglasswoolinthebottomofthecolumn(orburet)ifthe
column(orburet)isnotequippedwithintegralcoarse,frittedglassdisc.Overlaytheglasswoolpledget(or
frittedglassdisc)witha1520millimeterdeeplayeroffinesand.Measureinagraduatedcylinder15milliliters
ofchromatographicgradealuminumoxide(80200mesh)thathasbeentightlysettledbytappingthecylinder.
Transferthealuminumoxidetothechromatographictube,tappingthetubeduringandafterthetransfersoasto
tightlysettlethealuminumoxide.Overlaythelayerofaluminumoxidewitha1.01.5centimeterdeeplayerof
anhydroussodiumsulfateandontopofthisplacean810millimeterthickplugoffineglasswool.Nextcarefully
addabout25millilitersofheptanetothecolumnwithstopcockopen,andallowtheheptanetopassthroughthe
columnuntilthetopleveloftheliquidjustpassesintothetopglasswoolpluginthecolumn,andclosestopcock.
(3)Chromatographingofsampleextract(i)Forchloroformresiduesweighing0.5gramorless.Tothedriedand
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weighedchloroformsolubleextractresidueintheevaporatingdish,obtainedinparagraph(d)(5)(ii)ofthis
section,add20millilitersofheptaneandstir.Ifnecessary,heatcarefullytodissolvetheresidue.Additional
heptanenottoexceedatotalvolumeof50millilitersmaybeusedifnecessarytocompletedissolving.Cooltoroom
temperature.(Ifsolutionbecomescloudy,usetheprocedureinparagraph(d)(5)(iii)(b)(3)(ii)ofthissectionto
obtainanaliquotofheptanesolutioncalculatedtocontain0.10.5gramofchloroformsolubleextractresidue.)
Transfertheclearliquidsolutiontothecolumn(orburet).Rinsethedishwith10millimetersofadditional
heptaneandaddtocolumn.Allowtheliquidtopassthroughthecolumnintoaclean,taredevaporatingdish
(platinumorPyrex)atadropwiserateofabout2millilitersperminuteuntiltheliquidsurfacereachesthetop
glasswoolplugthenclosethestopcocktemporarily.RinsethePyrexflaskwhichcontainedthefiltratewithan
additional1015millilitersofheptaneandaddtothecolumn.Wash(elute)thecolumnwithmoreheptanecollecting
about100millilitersoftotaleluateincludingthatalreadycollectedintheevaporatingdish.Evaporatethe
combinedeluateintheevaporatingdishtodrynessonasteambath.Drytheresiduefor15minutesinanoven
maintainedatatemperatureofapproximately221deg.F.Cooltheevaporatingdishinadesiccatorfor30minutes
andweightheresiduetothenearest0.1milligram.Subtracttheweightoftheresiduefromtheweightof
chloroformsolubleextractivesresidue(')toobtainthewax,petrolatum,andmineraloilcorrectedchloroform
solubleextractivesresidue(e').Thise'issubstitutedforeintheequationsinparagraph(d)(5)(i)(a)and(b
)ofthissection.
(ii)Forchloroformresiduesweighingmorethan0.5gram.Redissolvethedriedandweighedchloroformsoluble
extractresidueasdescribedinparagraph(d)(5)(iii)(b)(3)(i)ofthissectionusingproportionatelylarger
quantitiesofheptane.Transfertheheptanesolutiontoanappropriatesizedvolumetricflask(i.e.,a250
milliliterflaskforabout2.5gramsofresidue)andadjusttovolumewithadditionalheptane.Pipetteoutan
aliquot(about50milliliters)calculatedtocontain0.10.5gramofthechloroformsolubleextractresidueand
analyzechromatographicallyasdescribedinparagraph(d)(5)(iii)(b)(3)(i)ofthissection.Inthiscasethe
weightofthedriedresiduefromtheheptaneeluatemustbemultipliedbythedilutionfactortoobtaintheweight
ofwax,petrolatum,andmineraloilresiduetobesubtractedfromtheweightofchloroformsolubleextractives
residue(')toobtainthewax,petrolatum,andmineraloilcorrectedchloroformsolubleextractivesresidue(e'
).Thise'issubstitutedforeintheequationsinparagraph(d)(5)(i)(a)and(b)ofthissection.(Note:Inthe
caseofchloroformsolubleextractswhichcontainhighmeltingwaxes(meltingpointgreaterthan170deg.F),itmay
benecessarytodilutetheheptanesolutionfurthersothata50milliliteraliquotwillcontainonly0.10.2gram
ofthechloroformsolubleextractresidue.)
(e)Acrylonitrilecopolymersidentifiedinthissectionshallcomplywiththeprovisionsof180.22ofthischapter,
exceptwherethecopolymersarerestrictedtouseincontactwithfoodonlyofthetypeidentifiedinparagraph(c),
table1underCategoryVIII.
[42FR14554,Mar.15,1977]
EditorialNote:
ForFederalRegistercitationsaffecting176.170,seetheListofCFRSectionsAffected,whichappearsinthe
FindingAidssectionoftheprintedvolumeandatwww.fdsys.gov.
Linksonthispage:
1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
2. http://www.addthis.com/bookmark.php
3. http://www.fda.gov/default.htm
4. http://www.fda.gov/MedicalDevices/default.htm
5. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm
6. /scripts/cdrh/cfdocs/search/default.cfm?FAQ=true
7. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/ucm135680.htm
PageLastUpdated:09/01/2014
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2. http://www.addthis.com/bookmark.php
3. http://www.fda.gov/default.htm
4. http://www.fda.gov/MedicalDevices/default.htm
5. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm
6. /scripts/cdrh/cfdocs/search/default.cfm?FAQ=true
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7. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/ucm135680.htm
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