FDA-21-CFR-177.1520-2007

1、28421CFRCh.I(4–1–07Edition)§177.1520(whichhasbeenheldinavacuumdes-iccatoroveranhydrouscalciumsulfateuntilconstantweighthasbeenat-tained)andcarefullyevaporatedtodryness.Theweightofthesolidresidueisdeterminedbydifferenceafterhold-inginavacuumdesiccatoroveranhy-drouscalciumsulfateuntilconstantweighthasbeenattained.Thepercentofsolidsextractediscalculatedbydi-vidingtheweightofthesolidresiduebytheweightofthesampleandmulti-plyingby100.(5)Viscositynumber(VN).(i)Thevis-cositynumber(VN)forNylon6/12resini。

2、na96percentsulfuricacidsolution(5milligramsresinpermilliliter)shallbedeterminedat25°C(77°F)bymethodISO307–1984(E),‘‘Plastics-Polyamides-DeterminationofViscosityNumber,’’whichisincorporatedbyreference.CopiesareavailablefromtheCenterforFoodSafetyandAppliedNutrition(HFS–200),FoodandDrugAdministra-tion,5100PaintBranchPkwy.,CollegePark,MD20740,oravailableforinspec-tionattheNationalArchivesandRecordsAdministration(NARA).ForinformationontheavailabilityofthismaterialatNARA,call202–741–6030,orgoto:(ii)Th。

3、eviscositynumber(VN)forNylon6/69andNylonPA–6–3–Tresinsina99percentcresolsolution(5milli-gramsresinpermilliliter)shallbede-terminedat25°C(77°F)bymethodISO307–1984(E),‘‘Plastics-Polyamides-De-terminationofViscosityNumber,’’whichisincorporatedbyreference.Theavailabilityofthisincorporationbyreferenceisgiveninparagraph(d)(5)(i)ofthissection.[42FR14572,Mar.15,1977]EDITORIALNOTE:ForFEDERALREGISTERci-tationsaffecting§177.1500,seetheListofCFRSectionsAffected,whichappearsintheFindingAidssectionoftheprinte。

4、dvolumeandonGPOAccess.§177.1520Olefinpolymers.Theolefinpolymerslistedinpara-graph(a)ofthissectionmaybesafelyusedasarticlesorcomponentsofarti-clesintendedforuseincontactwithfood,subjecttotheprovisionsofthissection.(a)Forthepurposeofthissection,olefinpolymersarebasicpolymersmanufacturedasdescribedinthispara-graph,soastomeetthespecificationsprescribedinparagraph(c)ofthissec-tion,whentestedbythemethodsde-scribedinparagraph(d)ofthissection.(1)(i)Polypropyleneconsistsofbasicpolymersmanufacturedbytheca。

5、ta-lyticpolymerizationofpropylene.(ii)Propylenehomopolymerconsistsofbasicpolymersmanufacturedbythecatalyticpolymerizationofpropylenewithametallocenecatalyst.(2)(i)Polyethyleneconsistsofbasicpolymersmanufacturedbythecata-lyticpolymerizationofethylene.(ii)Fumaricacid-graftedpoly-ethylene(CASReg.No.26877–81–6)con-sistsofbasicpolymersmanufacturedbythecatalyticpolymerizationofethylenefollowedbyreactionwithfu-maricacidintheabsenceoffreerad-icalinitiators.Suchpolymersshallcontaingraftedfumaricacidatlev。

6、elsnottoexceed2percentbyweightofthefinishedpolymer.(3)Olefinbasiccopolymersconsistofbasiccopolymersmanufacturedbythecatalyticcopolymerizationof:(i)Twoormoreofthe1-alkeneshav-ing2to8carbonatoms.Sucholefinbasiccopolymerscontainnotlessthan96weight-percentofpolymerunitsde-rivedfromethyleneand/orpropylene,exceptthat:(a)(1)Olefinbasiccopolymersmanu-facturedbythecatalyticcopolym-erizationofethyleneandhexene-1orethyleneandoctene-1shallcontainnotlessthan90weight-percentofpolymerunitsderivedfromethylene;(。

7、2)Olefinbasiccopolymersmanufac-turedbythecatalyticcopolymeriza-tionofethyleneandhexene-1shallcon-tainnotlessthan80butnotmorethan90weightpercentofpolymerunitsde-rivedfromethylene.(3)Olefinbasiccopolymersmanufac-turedbythecatalyticcopolymeriza-tionofethyleneandpentene-1shallcontainnotlessthan90weight-percentofpolymerunitsderivedfromethyl-ene.(4)Olefinbasiccopolymersmanufac-turedbythecatalyticpolymerizationofethyleneandoctene-1shallcontainnotlessthan50weight-percentofpoly-merunitsderivedfromethylen。

8、e.VerDateAug31200511:33Apr30,2007Jkt211067PO00000Frm00294Fmt8010Sfmt8010Y:\SGML\211067.XXX211067285FoodandDrugAdministration,HHS§177.1520(b)Olefinbasiccopolymersmanufac-turedbythecatalyticcopolymeriza-tionofethyleneand4-methylpentene-1shallcontainnotlessthan89weight-percentofpolymerunitsderivedfromethylene;(c)(1)Olefinbasiccopolymersmanu-facturedbythecatalyticcopolym-erizationoftwoormoreofthemono-mersethylene,propylene,butene-1,2-methylpropene-1,and2,4,4-trimethylpentene-1shallcontainnotlessthan。

9、85weight-percentofpolymerunitsderivedfromethyleneand/orpro-pylene;(2)Olefinbasiccopolymersmanufac-turedbythecatalyticcopolymeriza-tionofpropyleneandbutene-1shallcontaingreaterthan15butnotgreaterthan35weightpercentofpolymerunitsderivedfrombutene-1withtheremainderbeingpropylene.(d)Olefinbasicterpolymersmanufac-turedbythecatalyticcopolymeriza-tionofethylene,hexene-1,andeitherpropyleneorbutene-1,shallcontainnotlessthan85weightpercentpoly-merunitsderivedfromethylene.(e)Olefinbasiccopolymersmanufac-tu。

10、redbythecatalyticpolymerizationofethyleneandoctene-1,orethylene,octene-1,andeitherhexene-1,butene-1,propylene,or4-methylpentene-1shallcontainnotlessthan80weightpercentofpolymerunitsderivedfromethyl-ene.(ii)4-Methylpentene-1and1-alkeneshavingfrom6to18carbonatoms.Sucholefinbasiccopolymersshallcontainnotlessthan95molarpercentofpoly-merunitsderivedfrom4-methylpentene-1,exceptthatcopoly-mersmanufacturedwith1-alke。