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3000OldChemstrandRoadTel850-968-8682Cantonment,FL32533USAFax850-968-7990July7,2010tlwill@AscendMaterials.comVydyne®R533NTNaturalNylonResinFoodContactApplicationsVydyne®R533NTNaturalnylonresinmaybeusedworldwideinfoodcontactapplications.Therearenofoodtypeoruserestrictionsplacedonthisresinbyanygovernmentbody.UnitedStates-Vydyne®R533NTNaturalisformulatedandmanufacturedtomeettherelevantrequirementsoftheU.S.FoodandDrugAdministration(FDA)regulations.ThisresinisprimarilyNylon6,6polymer,andmeetstherequirementsof21CFR177.1500(b)(1).Thisresincontainsadditives,andeachoftheseproprietaryadditivesmeetsoneormoreofvariousrequirementsin21CFR–Specificcitationasafoodcontactmaterial,GRASStatus,DirectFoodAdditivestatus,orThresholdofRegulation(TOR)exemption.EuropeanUnion-Vydyne®R533NTNaturalmeetsallrelevantrequirementsofthefollowingEuropeanRegulationsandDirectives:•Regulation(EC)1935/2004–TheFrameworkRegulation•Directive2002/72/EC,uptothe6thamendment(CommissionRegulation975/2009)–theFoodContactPlasticsDirective•Regulation(EC)No2023/2006–TheGoodManufacturingPracticesRegulationVydyne®R533NTNaturalcontainsthefollowingsubstanceswhicharesubjecttoaSpecificMigrationLimitunderDirective2002/72/EC,inAnnexIIorIII:ComponentSMLHexamethyleneDiamineSML(T)=2.4mg/kgCompliancewiththeseSML’s,aswellastheOverallMigrationLimit(OML)isafunctionofthecomposition,shape,sizeanduseconditionsofthefinishedarticle.Compliancewiththeselimitsshouldbedeterminedbythecustomer.Vydyne®R533NTNaturalcontainsnoadditiveswhichareauthorizedasfoodadditivesorflavoringsby89/107/EECor88/388/EEC.Allnylon6,6polymerscontainAdipicAcidandmaycontainAceticAcidasmonomers.AdipicAcidandAceticAcidsareauthorizedbyEFSAasfoodadditivesand/orflavoringingredients.Vydyne®R533NTNaturalmeetsallrelevantrequirementsofGermany’sFoodandFeedCode(LFGB).Vydyne®R533NTNaturalnylonresiniscertifiedbytheNationalSanitationFoundation(NSF)asmeetingtherequirementsofNSFStandard51–FoodContactMaterials.Itisapprovedforuseincontactwithallfoodtypeswithoutrestriction.Thelistingmaybefoundat=4F050&Standard=051IfyouhavefurtherquestionsaboutthisoranyAscendPerformanceMaterialsproduct,pleasedonothesitatetocontactus.Regards,TravisL.WillardProductStewardshipLeadAscendPerformanceMaterialsLLC
本文标题:美国首诺-PA-FDA认证报告书
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