Designation:D4754−11StandardTestMethodforTwo-SidedLiquidExtractionofPlasticMaterialsUsingFDAMigrationCell1ThisstandardisissuedunderthefixeddesignationD4754;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope*1.1ThistestmethodcoverstheuseoftheFDAmigrationcellintheextractionofcomponentsandpermitsquantitationofindividualmigrantsfromplasticmaterialsbysuitableextract-ingliquids,includingliquidfoodsandfood-stimulatingsol-vents.1.2Thistestmethodprovidesatwo-sided,liquidextractiontestforplasticmaterialsthatcanbeformedintofilm,sheet,ordisks.1.3Thistestmethodhasbeenappliedtoavarietyofmigrant/polymersystemsincontactwithnumerousfoodsandfoodsimulants.2Thoughmostofthemigrantsexaminedwereradiolabeled,theuseoftheFDAcellhasbeenvalidatedformigrationstudiesofunlabeledsytrenefrompolystyrene.31.4ThistestmethodhasbeenshowntoyieldreproducibleresultsundertheconditionsformigrationtestsrequestedbytheFDA.However,ifthedataistobesubmittedtotheFDA,itissuggestedthattheirguidelinesbeconsulted.1.5Becauseitemploystwo-sidedextraction,thistestmethodmaynotbesuitableformulti-layeredplasticsintendedforsingle-sidedfoodcontactuse.1.6ThesizeoftheFDAmigrationcellasdescribedmayprecludeitsuseindeterminingtotalnonvolatileextractivesinsomecases.NOTE1—Formoreinformation,seePracticeD1898,theAOACMethodsofAnalysisonFlexibleBarrierMaterialsExposedforExtraction,andtheGuidanceforIndustry:PreparationofPremarketSubmissionsforFoodContactSubstances:ChemistryRecommendations,December2007.1.7Analyticalproceduresmustbeavailabletoquantitatethemigrant(s)generatedbythistestmethod.1.8ThevaluesstatedinSIunitsaretoberegardedasthestandard.1.9Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesandde...
