21cfr176.170

19821CFRCh.I(4–1–08Edition)§176.170componentofpaperforpackagingdryfoodwhenusedinaccordancewiththefollowingprescribedconditions.(a)Thefoodadditiveisusedasacomponentofpaperinanamountnottoexceed0.5percentbyweightofthepaper.(b)(1)Thefood-contactsurfaceofthepaperisovercoatedwithapolymericorresinouscoatingatleast1⁄3-milinthickness,thatmeetstheprovisionof§176.170;or(2)Thetreatedpaperformsoneormorepliesofapaperinamultiwallbagandisseparatedfromthefoodbyatleastoneplyofpackagingfilmsorgrease-resistantpaperswhichservesasafunctionalbarrierbetweenthefoodadditiveandthefood.Suchpackagingfilmsorgrease-resistantpaperscon-formwithappropriatefoodadditiveregulations.(c)Thelabelingofthefoodadditiveshallcontainadequatedirectionsforitsusetoinsurecompliancewiththerequirementsofparagraphs(a)and(b)ofthissection.§176.170Componentsofpaperandpa-perboardincontactwithaqueousandfattyfoods.Substancesidentifiedinthissectionmaybesafelyusedascomponentsoftheuncoatedorcoatedfood-contactsurfaceofpaperandpaperboardin-tendedforuseinproducing,manufac-turing,packaging,processing,pre-paring,treating,packing,transporting,orholdingaqueousandfattyfoods,subjecttotheprovisionsofthissec-tion.Componentsofpaperandpaper-boardincontactwithdryfoodofthetypeidentifiedunderTypeVIIIoftable1inparagraph(c)ofthissectionaresubjecttotheprovisionsof§176.180.(a)Substancesidentifiedinpara-graph(a)(1)through(5)ofthissectionmaybeusedascomponentsofthefood-contactsurfaceofpaperandpaper-board.Paperandpaperboardproductsshallbeexemptedfromcompliancewiththeextractiveslimitationspre-scribedinparagraph(c)ofthissection:Provided,Thatthecomponentsofthefood-contactsurfaceconsistentirelyofoneormoreofthesubstancesidenti-fiedinthisparagraph:Andprovidedfur-ther,Thatifthepaperorpaperboardwhenextractedundertheconditionsprescribedinparagraph(c)ofthissec-tionexceedsthelimitationsonextrac-tivescontainedinparagraph(c)ofthissection,informationshallbeavailablefrommanufacturingrecordsfromwhichitispossibletodeterminethatonlysubstancesidentifiedinthispara-graph(a)arepresentinthefood-con-tactsurfaceofsuchpaperorpaper-board.(1)Substancesgenerallyrecognizedassafeinfood.(2)Substancesgenerallyrecognizedassafefortheirintendeduseinpaperandpaperboardproductsusedinfoodpackaging.(3)Substancesusedinaccordancewithapriorsanctionorapproval.(4)Substancesthatbyregulationinparts170through189ofthischaptermaybesafelyusedwithoutextractiveslimitationsascomponentsoftheuncoatedorcoatedfood-contactsur-faceofpaperandpaperboardincontactwithaqueousorfattyfood,subjecttotheprovisionsofsuchregulation.(5)Substancesidentifiedinthispara-graph,asfollows:ListofSubstancesLimitationsAcetylperoxide............................................................................Foruseonlyaspolymerizationcatalyst.Acrylamide-methacrylicacid-maleicanhydridecopolymerscon-tainingnotmorethan0.2percentofresidualacrylamidemonomerandhavinganaveragenitrogencontentof14.9percentsuchthata1percentbyweightaqueoussolutionhasaminimumviscosityof600centipoisesat75°F,asde-terminedbyLVG-seriesBrookfieldviscometer(orequivalent)usingaNo.2spindleat30r.p.m.Foruseonlyasaretentionaidemployedpriortothesheet-formingoperationinthemanufactureofpaperandpaper-boardinsuchanamountthatthefinishedpaperandpaper-boardwillcontaintheadditiveatalevelnotinexcessof0.05percentbyweightofdryfibersinthefinishedpaperandpaperboard.Acrylamide-b-methacrylyloxyethyltrimethylammoniummethylsulfatecopolymerresinscontainingnotmorethan10molarpercentofb-methacrylyloxyethyltrimethylammoniummethylsulfateandcontaininglessthan0.2%ofresidualacrylamidemonomer.Foruseonlyasaretentionaidandflocculantemployedpriortothesheet-formingoperationinthemanufactureofpaperandpaperboard.Acrylicacid,sodiumsaltcopolymerwithpolyethyleneglycolallylether(CASReg.No.86830–15–1).Foruseonlyinpapermillboilers.VerDateAug31200518:38Apr28,2008Jkt214067PO00000Frm00208Fmt8010Sfmt8010Y:\SGML\214067.XXX214067mstockstillonPROD1PC66withCFR199FoodandDrugAdministration,HHS§176.170ListofSubstancesLimitationsAcrylicacidcopolymerwith2-acrylamido-2-methylpropane-sul-fonicacid(CASReg.No.40623–75–4)and/oritsammo-nium/alkalimetalmixedsalts.Thecopolymerisproducedbypoly-merizationofacrylicacidand2-acrylamido-2-methylpropane-sulfonicacidinaweightratioof60/40,suchthata28percentbyweightaqueoussolutionofthepolymerhasaviscosityof75–150centipoisesat25°Casdeter-minedbyLV-seriesBrookfieldviscometer(orequivalent)usingaNo.2spindleat60r.p.m.Foruseonlyasascaleinhibitorpriortothesheet-formingop-erationinthemanufactureofpaperandpaperboardandusedatalevelnottoexceed1.0kilogram(2.2pounds)ofcopolymerper907kilograms(1ton)ofdrypaperandpaper-boardfibers.Acrylonitrilepolymer,reactionproductwithethylenediaminesulfatehavinganitrogencontentof22.5–25.0percent(Kjel-dahldrybasis)andcontainingnomorethan0.075percentmonomerasethylenediamine.Thefinishedresinina24per-centbyweightaqueoussolutionhasaviscosityof1,000–2,000centipoisesat25°CasdeterminedbyLVT-seriesBrookfieldviscometerusingaNo.4spindleat50r.p.m.(orbyotherequivalentmethod).Foruseonlyasasizepromoterandretentionaidatalevelnot