CFR-2014-title21-vol3-sec177-1350

CFR-2014-title21-vol3-sec177-135021CFRCh.I(4–1–14Edition)§177.1350identifiedinparagraph(a)ofthissec-tionhasadensityof1.33±0.02gramspercubiccentimetermeasuredbyASTMMethodD1505–85(Reapproved1990),‘‘StandardTestMethodforDensityofPlasticsbytheDensity-GradientTech-nique,’’whichisincorporatedbyref-erenceinaccordancewith5U.S.C.552(a)and1CFRpart51.CopiesmaybeobtainedfromtheAmericanSocietyforTestingandMaterials,100BarrHarborDr.,WestConshohocken,Phila-delphia,PA19428-2959,ormaybeexam-inedattheCenterforFoodSafetyandAppliedNutrition’sLibrary,FoodandDrugAdministration,5100PaintBranchPkwy.,CollegePark,MD20740,andattheNationalArchivesandRecordsAdministration(NARA).ForinformationontheavailabilityofthismaterialatNARA,call202–741–6030,orgoto:(2)Softeningpoint.Ethylene/1,3–phen-yleneoxyethyleneisophthalate/terephthalatecopolymeridentifiedinparagraph(a)ofthissectionhasasoft-eningpointof63±5°CasmeasuredbyASTMMethodD1525–87,‘‘StandardTestMethodforVICATSofteningTem-peratureofPlastics,’’whichisincor-poratedbyreferenceinaccordancewith5U.S.C.552(a)and1CFRpart51.Theavailabilityofthismaterialispro-videdinparagraph(b)(1)ofthissec-tion.(c)Optionaladjuvantsubstances.Ethylene/1,3–phenyleneoxyethyleneisophthalate/terephthalatecopolymer,identifiedinparagraph(a)ofthissec-tion,maycontainoptionaladjuvantsubstancesrequiredintheirproduc-tion.Theoptionaladjuvantsmayin-cludesubstancesusedinaccordancewith§174.5ofthischapter.(d)Limitations.Copolymerblendsde-scribedaboveshallnotexceed30per-centbyweightofethylene/1,3-phen-yleneoxyethyleneisophthalate/terephthalatecopolymer.ThefinishedblendmaybeusedincontactwithfoodonlyunderconditionsofuseCthroughG,asdescribedintable2of§176.170(c)ofthischapter,exceptthatwithfoodidentifiedasTypeIII,IV-A,V,VII-A,andIXin§176.170(c),table1,theco-polymermaybeusedunderconditionofuseCattemperaturesnottoexceed160°F(71°C).[57FR43399,Sept.21,1992,asamendedat59FR62318,Dec.5,1994;61FR14481,Apr.2,1996;62FR34628,June27,1997]§177.1350Ethylene-vinylacetateco-polymers.Ethylene-vinylacetatecopolymersmaybesafelyusedasarticlesorcom-ponentsofarticlesintendedforuseinproducing,manufacturing,packing,processing,preparing,treating,pack-aging,transporting,orholdingfoodinaccordancewiththefollowingpre-scribedconditions:(a)(1)Ethylene-vinylacetatecopoly-mersconsistofbasicresinsproducedbythecatalyticcopolymerizationofethyleneandvinylacetatetowhichmayhavebeenaddedcertainoptionalsubstancestoimpartdesiredtechno-logicalorphysicalpropertiestotheresin.Subjecttoanylimitationspre-scribedinthissection,theoptionalsubstancesmayinclude:(i)Substancesgenerallyrecognizedassafeinfoodandfoodpackaging.(ii)Substancestheuseofwhichispermittedunderapplicableregulationsinparts170through189ofthischapter,priorsanction,orapprovals.(iii)Substancesidentifiedin§175.300(b)(3)(xxv),(xxvii),(xxx),and(xxxiii)ofthischapter,andcolorantsusedinaccordancewith§178.3297ofthischapter.(iv)Erucamideasidentifiedin§178.3860ofthischapter.(v)Xanthangumasidentifiedin§172.695foruseasathickeningagentatalevelnottoexceed1percentbyweightofcoatingsolidsinaqueousdis-persionsofethylene-vinylacetateco-polymers,wheresuchcopolymersareusedonlyascoatingsoracomponentofcoatings.(vi)Thecopolymerofvinylideneflu-orideandhexafluoropropene(CASReg.No.9011–17–0),containing65to71per-centfluorineandhavingaMooneyVis-cosityofatleast28,foruseasaproc-essingaidatalevelnottoexceed0.2percentbyweightofethylene-vinylac-etatecopolymers.(2)Maleicanhydride-graftedethyl-ene-vinylacetatecopolymers(CASFoodandDrugAdministration,HHS§177.1350Reg.No.28064–24–6)consistofbasicres-insproducedbythecatalyticcopolym-erizationofethyleneandvinylacetate,followedbyreactionwithmaleicanhy-dride.Suchpolymersshallcontainnotmorethan11percentofpolymerunitsderivedfromvinylacetatebyweightoftotalpolymerpriortoreactionwithmaleicanhydride,andnotmorethan2percentofgraftedmaleicanhydridebyweightofthefinishedpolymer.Op-tionaladjuvantsubstancesthatmaybeaddedtothecopolymersincludesub-stancesgenerallyrecognizedassafeinfoodandfoodpackaging,substancestheuseofwhichispermittedunderap-plicableregulationsinparts170through189ofthischapter,andsub-stancesidentifiedin§175.300(b)(3)(xxv),(xxvii),(xxxiii),and(xxx)ofthischap-terandcolorantsforpolymersusedinaccordancewiththeprovisionsof§178.3297ofthischapter.(b)(1)Ethylene-vinylacetatecopoly-mers,withorwithouttheoptionalsub-stancesdescribedinparagraph(a)ofthissection,whenextractedwiththesolventorsolventscharacterizingthetypeoffood,andunderconditionsoftimeandtemperaturecharacterizingtheconditionsoftheirintendeduseasdeterminedfromtables1and2of§176.170(c)ofthischapter,shallyieldnetchloroform-solubleextractivescor-rectedforzincaszincoleatenottoex-ceed0.5milligrampersquareinchofanappropriatesample.(2)Maleicanhydridegraftedethyl-ene-vinylacetatecopolymersshallhaveameltflowindexnottoexceed2.1gramsper10minutesasdeterminedbyASTMmethodD1238–82,‘‘StandardTestMethodforFlowRatesofThermo-plasticsbyExtrusionPlastometer,’’whichisincorporatedbyreferenceinaccordancewith5U.S.C.552(a).CopiesmaybeobtainedfromtheAmericanSocietyforTestingMaterials,100BarrHarborDr.,WestConshohocken,Phila-delphia,PA19428-2959,orattheOfficeofFoodAdditiveSafety(HFS–200),CenterforFoodSafetyandAppliedNu-trition,FoodandDrugAdministration,5100PaintBranchPkwy.,CollegePark,MD20740,240–402–1200,ormaybeexam-inedattheCenterforFoodSafetyandAppliedNutrition’sLibrary,5100PaintBranchPkwy.,CollegePark,MD20740,orattheNationalArchivesandRecordsAdministration(NARA).ForinformationontheavailabilityofthismaterialatNARA,call202–741–6030,orgoto:codeloflfederallregulations/ibrllocations.html.Complianceofthemeltflowindexspecificationshallbedeterminedusingconditionsandproce-durescorrespondingtothosedescribedinthemethodasConditionE,Proce-dureA).Thecopolymersshallbeusedinblendswithotherpolymersatlevelsnottoexceed17percentbyweightoftotalpolymer,subjecttothelimita-tionthatwhencontactingfoodoftypesIII,IV-A,V,VI-C,VII-A,andIX,iden-tifiedin§176.170(c)ofthischapter,Table1,thepolymersshallbeusedonlyunderconditionsofuseC,D,E,F,andG,describedin§176.170(c)ofthischapter,Table2.(c)Theprovisionsofparagraph(b)ofthissectionarenotapplicabletoethyl-ene-vinylacetatecopolymersusedinfood-packagingadhesivescomplyingwith§175.105ofthischapter.(d)Ethylene-vinylacetatecopoly-mersmaybeirradiatedunderthefol-lowingconditionstoproducemolecularcrosslinkingofthepolymerstoimpartdesiredpropertiessuchasincreasedstrengthandincreasedabilitytoshrinkwhenexposedtoheat:(1)Electronbeamsourceofionizingradiationatamaximumenergyof3millionelectronvolts:Maximumab-sorbeddosenottoexceed150kiloGray(15megarads).(2)Thefinishedfood-contactfilmshallmeettheextractiveslimitationsprescribedinparagraph(e)(2)ofthissection.(3)Theethylene-vinylacetateco-polymerfilmsmaybefurtherirradi-atedinaccordancewiththeprovisionsofparagraph(e)(1)ofthissection:Pro-vided,Thatthetotalaccumulatedradi-ationdosefrombothelectronbeamandgammarayradiationdoesnotex-ceed150kiloGray(15megarads).(e)Ethylene-vinylacetatecopolymerfilmsintendedforcontactwithfoodmaybeirradiatedtocontrolthegrowthofmicroorganismsunderthefollowingconditions:(1)Gammaphotonsemittedfromacobalt–60sealedsourceinthedose21CFRCh.I(4–1–14Edition)§177.1360rangeof5–50kiloGray(0.5–5.0megarads).(2)Theirradiatedethylene-vinylace-tatecopolymerfilms,whenextractedwithreagentgraden-heptane(freshlyredistilledbeforeuse)accordingtomethodsdescribedunder§176.170(d)(3)ofthischapter,at75°Ffor30minutesshallyieldtotalextractivesnottoex-ceed4.5percentbyweightofthefilm.[42FR14572,Mar.15,1977,asamendedat43FR29287,July7,1978;54FR35874,Aug.30,1989;55FR18595,May3,1990;56FR42932,Aug.30,1991;64FR47108,Aug.30,1999;78FR14665,Mar.7,2013]§177.1360Ethylene-vinylacetate-vinylalcoholcopolymers.Ethylene-vinylacetate-vinylalcoholcopolymers(CASReg.No.26221–27–2)maybesafelyusedasarticlesorcom-ponentsofarticlesintendedforuseincontactwithfood,inaccordancewiththefollowingprescribedconditions:(a)Ethylene-vinylacetate-vinylalco-holcopolymersareproducedbythepartialorcompletealcoholysisorhy-drolysisofthoseethylene-vinylacetatecopolymerscomplyingwith§177.1350.(1)Thosecopolymerscontainingaminimumof55percentethyleneandamaximumof30percentvinylalcoholunitsbyweightmaybeusedincontactwithfoodsasdescribedinparagraph(b)ofthissection.(2)Thosecopolymerscontainingaminimumof55percentethyleneandamaximumof15percentvinylalcoholunitsbyweightmaybeusedincontactwithfoodsasdescribedinparagraph(c)ofthissection.(3)Thosecopolymerscontaining17to40percentethyleneand60to83percentvinylalcoholunitsbyweightmaybeusedincontactwithfoodsasdescribedinparagraph(d)ofthissection.(b)Thefinishedfood-contactarticleshallnotexceed0.013centimeter(0.005inch)thicknessandshallcontactfoodsonlyofthetypesidentifiedintable1of§176.170(c)ofthischapterinCategoriesI,II,IV-B,VI,VII-B,andVIIIunderconditionsofuseDthroughGde-scribedintable2of§176.170(c)ofthischapter.Filmsamplesof0.013centi-meter(0.005)inchthicknessrep-resentingthefinishedarticleshallmeetthefollowingextractivelimita-tionwhentestedbyASTMmethodF34–76(Reapproved1980),‘‘StandardTestMethodforLiquidExtractionofFlexibleBarrierMaterials,’’whichisincorporatedbyreference.CopiesmaybeobtainedfromtheAmericanSocietyforTestingMaterials,100BarrHarborDr.,WestConshohocken,Philadelphia,PA19428-2959,ormaybeexaminedattheNationalArchivesandRecordsAd-ministration(NARA).ForinformationontheavailabilityofthismaterialatNARA,call202–741–6030,orgoto:http://www.archives.gov/federallregister/codeloflfederallregulations/ibrllocations.html.(1)Thefilmwhenextractedwithdis-tilledwaterat21°C(70°F)for48hoursyieldstotalextractivesnottoexceed0.0047milligrampersquarecentimeter(0.03milligrampersquareinch)offood-contactsurface.(2)Thefilmwhenextractedwith50percentethylalcoholat21°C(70°F)for48hoursyieldstotalextractivesnottoexceed0.0062milligrampersquarecen-timeter(0.04milligrampersquareinch)offood-contactsurface.(c)Thefinishedfood-contactarticleshallnotexceed0.0076centimeter(0.003inch)thicknessandshallcontactfoodsonlyofthetypesidentifiedintable1of§176.170(c)ofthischapterinCategoriesIII,IV-A,VII-A,andIXundercondi-tionsofuseFandGdescribedintable2of§176.170(c)ofthischapter.Filmsamplesof0.0076centimeter(0.003inch)thicknessrepresentingthefinishedar-ticlesshallmeetthefollowingextrac-tivelimitationwhentestedbyASTMmethodF34–76(Reapproved1980),‘‘StandardTestMethodforLiquidEx-tractionofFlexibleBarrierMaterials,’’whichisincorporatedbyreference.Theavailabilityofthisincorporationbyreferenceisgiveninparagraph(b)ofthissection.Thefilmwhenextractedwithn-heptaneat38°C(100°F)for30minutesyieldstotalextractivesnottoexceed0.0078milligrampersquarecen-timeter(0.05milligrampersquareinch)offood-contactsurface,aftercor-rectingthetotalextractivesbydivid-ingbyafactoroffive.(d)Thefinishedfood-contactarticleshallnotexceed0.018centimeter(0.007inch)thicknessandmaycontactallfoods,exceptthosecontainingmorethan8percentalcohol,undercondi-tionsofuseBthroughHdescribedin