1、BRITISH STANDARD BS EN 1186-14:2002 Materials and articles in contact with foodstuffs Plastics Part 14: Test methods for substitute tests for overall migration from plastics intended to come into contact with fatty foodstuffs using test media iso-octane and 95 % ethanol The European Standard EN 1186
2、-14:2002 has the status of a British Standard ICS 67.250 BS EN 1186-14:2002 This British Standard, having been prepared under the direction of the Consumer Products and Services Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on
3、14 October 2002 BSI 14 October 2002 ISBN 0 580 40570 2 National foreword This British Standard is the official English language version of EN 1186-14:2002. It supersedes DD ENV 1186-14:1999 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CW/47, Materi
4、als and articles in contact with foodstuffs, to Subcommittee CW/47/1, Migration from plastics, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international o
5、r European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to inc
6、lude all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enqu
7、iries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 20, an inside
8、back cover and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN118614 September2002 ICS67.250 Englishversion Materialsandarticlesinc
9、ontactwithfoodstuffsPlasticsPart 14:Testmethodsforsubstitutetestsforoverallmigrationfrom plasticsintendedtocomeintocontactwithfattyfoodstuffsusing testmediaisooctaneand95%ethanol Matriauxetobjetsencontactaveclesdenres alimentairesMatireplastiquePartie14:Mthodes dessaipourdestestsdesubstitutionpourla
10、migration globaledesmatiresdestinesaucontactavecles denresalimentairesgrasenutilisantdesliquides simulateurstelsquelisooctaneetlthanol95% WerkstoffeundGegenstndeinKontaktmitLebensmitteln KunststoffeTeil14:Prfverfahrenfr“Ersatzprfungen” frdieGesamtmigrationausKunststoffen,diefrden KontaktmitfettigenL
11、ebensmittelnbestimmtsind,unter VerwendungderPrfmedienIsoOctanund95%igem Ethanol ThisEuropeanStandardwasapprovedbyCENon29April2002. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration
12、.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitso
13、wnlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom
14、. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2002CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN118614:2002EEN118614:2002(E) 2 Contents page Foreword3 1
15、 Scope 4 2 Normativereferences 4 3 Totalimmersionmethod .5 3.1 Principle5 3.2 Reagents.5 3.3 Apparatus .5 3.4 Preparationoftestspecimens. .6 3.4 Procedure .6 3.4.1 Exposuretotestmedia .6 3.4.2 Determinationofmigratingsubstances . .7 3.5 Expressionofresults . .7 3.6 Testreport . .7 4 Cellmethod. 8 4.
16、1 Principle8 4.2 Reagents.8 4.3 Apparatus .8 4.4 Preparationoftestspecimens. .9 4.5 Procedure .9 4.5.1 Exposuretotestmedia .9 4.5.2 Determinationofmigratingsubstances . .10 4.6 Expressionofresults .10 4.7 Testreport . .10 5 Pouchmethod 11 5.1 Principle11 5.2 Reagents.11 5.3 Apparatus .11 5.4 Prepara
17、tionoftestspecimens. .12 5.5 Procedure .12 5.5.1 Exposuretotestmedia .12 5.5.2 Determinationofmigratingsubstances . .13 5.6 Expressionofresults . .13 5.7 Testreport . .13 6 Articlefillingmethod .14 6.1 Principle14 6.2 Reagents.14 6.3 Apparatus .14 6.4 Preparationoftestspecimens. .15 6.5 Procedure .1
18、5 6.5.1 Exposuretotestmedia .15 6.5.2 Determinationofmigratingsubstances . .16 6.6 Expressionofresults . .16 6.7 Testreport . .16 AnnexA (informative) Exampleofapouchholder .17 AnnexZA (informative) RelationshipofthisEuropeanStandardwithCouncilDirective89/109/EEC andCommissionDirective90/128/EECanda
19、ssociatedDirectives18 Bibliography 20EN118614:2002(E) 3 Foreword ThisdocumentEN118614hasbeenpreparedbyTechnicalCommitteeCEN/TC194”Utensilsincontactwith food”,thesecretariatofwhichisheldbyBSI. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextor byendors
20、ement,atthelatestbyMarch2003,andconflictingnationalstandardsshallbewithdrawnatthelatestby March2003. ThisdocumentsupersedesENV118614:1999. ForrelationshipwithEUDirective(s),seeinformativeannexZA,whichisanintegralpartofthisdocument. ThisEuropeanStandardhasbeenpreparedasoneofaseriesoftestmethodsforpla
21、sticsmaterialsandarticlesin contactwithfoodstuffs. WARNINGBothisooctaneandethanolarevolatileflammablesolvents.Takecaretoensurethatthe testspecimensarewellstoppered,closedandcoveredtopreventsolventvolatilizingintotheinteriorof theoven,incubatororrefrigeratorandgeneratinganexplosivemixture.Careshouldb
22、etakenatalltimes whenhandlingthesesolventstopreventcontactwithsourcesofignition. EN118614shouldbereadinconjunctionwithEN11861,EN11863,EN11865,EN18867,andEN11869. FurtherPartsofthisstandardhavebeenpreparedconcernedwiththedeterminationofoverallmigrationfrom plasticsmaterialsintofoodsimulants.Theirtitl
23、esareasfollows: EN1186MaterialsandarticlesincontactwithfoodstuffsPlastics Part1 Guidetotheselectionofconditionsandtestmethodsforoverallmigration Part2 Testmethodsforoverallmigrationintooliveoilbytotalimmersion Part3 Testmethodsforoverallmigrationintoaqueousfoodsimulantsbytotalimmersion Part4 Testmet
24、hodsforoverallmigrationintooliveoilbycell Part5 Testmethodsforoverallmigrationintoaqueousfoodsimulantsbycell Part6 Testmethodsforoverallmigrationintooliveoilusingapouch Part7 Testmethodsforoverallmigrationintoaqueousfoodsimulantsusingapouch Part8 Testmethodsforoverallmigrationintooliveoilbyarticlefi
25、lling Part9 Testmethodsforoverallmigrationintoaqueoussimulantsbyarticlefilling Part10 Testmethodsforoverallmigrationintooliveoil(modifiedmethodforuseincaseswhere incompleteextractionofoliveoiloccurs) Part11 Testmethodsforoverallmigrationintomixturesof 14 Clabelledsynthetictriglyceride Part12 Testmet
26、hodsforoverallmigrationatlowtemperatures Part13 TestmethodsforoverallmigrationathightemperaturesEN118614:2002(E) 4 Part15 Alternativetestmethodstomigrationintofattyfoodsimulantsbyrapidextractionintoiso octaneand/or95%ethanol AnnexAisinformative. AccordingtotheCEN/CENELECInternalRegulations,thenation
27、alstandardsorganizationsofthefollowing countriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,CzechRepublic,Denmark,Finland, France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain, Sweden,SwitzerlandandtheUnitedKingdom. 1Scope ThisEuropeanStandardspe
28、cifiestestmethodsforsubstitutetestsperformedwithvolatiletestmedia,isooctane and95%v/vaqueousethanol,forthedeterminationofoverallmigrationfromplasticsintendedtocomeinto contactwithfattyfoodstuffsatalltemperaturesandforanyperiodoftime. Thesetestmethodsaresuitableforplasticssamplesinawidevarietyofforms
29、. NOTE1 Theisooctaneand95%v/vaqueousethanolvolatiletestmediausedinthesetestmethodsarethosespecifiedfor substitutetestsinCommissionDirective82/711/EEC3anditssubsequentamendments4,5.Inadditiontotheuseofis o octaneand95%v/vaqueousethanolastestmediaforsubstitutetests,CommissionDirective82/711/EECanditss
30、ubsequent amendmentsspecifiestheuseofmodifiedpolyphenyleneoxideasatestmediumforuseattemperaturesof100 Candabove. Foratestmethodforoverallmigrationfromplasticsintendedtocomeintocontactwithfattyfoodstuffsusingmodified polyphenyleneoxideasatestmedium,seeEN118613. NOTE2 Thesetestmethodscanalsobeusedfort
31、healternativetestsdescribedinCouncilDirective82/711/EECandits subsequentamendments,whenthechosenvolatiletestmediaareisooctaneand95%aqueousethanol,providedequivalence isshownwitholiveoil,seeEN11861:2002. 2 Normativereferences ThisEuropeanStandardincorporatesbydatedandundatedreference,provisionsfromot
32、herpublications.These normativereferencesarecitedattheappropriateplacesinthetext,andthepublicationsarelistedhereafter.For datedreferences,subsequentamendmentstoandrevisionsofanyofthesepublicationsapplytothisEuropean Standardonlywhenincorporatedinitbyamendmentorrevision.Forundatedreferencesthelateste
33、ditionofthe publicationreferredtoapplies(includingamendments). EN11861:2002, MaterialsandarticlesincontactwithfoodstuffsPlasticsPart1:Guidetotheselectionof conditionsandtestmethodsforoverallmigration. EN11863:2002, MaterialsandarticlesincontactwithfoodstuffsPlasticsPart3:Testmethodsforoverall migrat
34、ionintoaqueousfoodsimulantsbytotalimmersion. EN11865:2002,MaterialsandarticlesincontactwithfoodstuffsPlasticsPart5:Testmethodsforoverall migrationintoaqueousfoodsimulantsbycell. EN11867:2002, MaterialsandarticlesincontactwithfoodstuffsPlasticsPart7:Testmethodsforoverall migrationintoaqueousfoodsimul
35、antsusingapouch. EN11869:2002, MaterialsandarticlesincontactwithfoodstuffsPlasticsPart9:Testmethodsforoverall migrationintoaqueousfoodsimulantsbyarticlefilling. EN100881:1995, StainlesssteelsPart1:Listofstainlesssteels. ISO648, LaboratoryglasswareOnemarkpipettes . ISO4788, LaboratoryglasswareGraduat
36、edmeasuringcylinders.EN118614:2002(E) 5 3 Totalimmersionmethod 3.1Principle Theoverallmigrationofnonvolatilesubstancesfromasampleoftheplasticsmaterialorarticleintothetest mediumisdeterminedasthemassofnonvolatileresidueafterevaporationofthetestmediumfollowing immersion. Theselectionoftheconditionsoft
37、estisdeterminedbytheconditionsofuse,seeclauses6and7of EN11861:2002. Testspecimensofapproximately1dm,seeclause9ofEN11861:2002,areimmersedinatestmediumforset periodsoftimeandatsettemperatures.Attheendofthetestperiod,eachtestspecimenisremovedfromthetest medium.Thetestmediumfromeachtestisevaporatedtodry
38、ness,themassofthenonvolatileresidueis determinedgravimetricallyandexpressedasmilligramspersquaredecimetreofsurfaceareaoftestspecimen. Overallmigrationisreportedasthemeanofthreedeterminationsonseparatetestspecimens. 3.2Reagents 3.2.1 Isooctane,(2,2,4trimethylpentane),purity98,5%(v/v)orgreater,CASNo.5
39、40841 1 . 3.2.2 Ethanol,purity96%(v/v)orgreater,95%(v/v)inaqueoussolution. WARNINGBoththesesolventsareflammable.Takecareatalltimeswhenhandlingthesesolventsto preventcontactwithsourcesofignition. 3.3Apparatus 3.3.1 Cuttingslab,cleansmoothglass,metalorplasticsslabofsuitableareatopreparetestspecimens,
40、250mm 250mmissuitable. 3.3.2 Tweezers,stainlesssteel,bluntnosed. 3.3.3 Cuttingimplement,scalpel,scissorsorsharpknifeorothersuitabledevice. 3.3.4 Metaltemplate,100mm 0,2mmx100mm 0,2mm(square). 3.3.5 Ruleortemplate,25mm 1mmwide. 3.3.6 Rule,graduatedinmm,andwithanaccuracyof0,1mm. 3.3.7 Analyticalbalanc
41、ecapabledeterminingachangeinmassof0,1mg. 3.3.8 Specimensupports,constructedofstainlesssteelwithcrossarmsattachedbyweldingorsilversoldering, orofglass.StainlesssteelX4CrNi1810accordingtoEN100881:1995orofcomposition,chromium17%,nickel 9%,carbon0,04%,issuitable.Beforeinitialusethoroughlycleanthestainle
42、sssteelsupports.Theuseofa degreasingsolventandthenwithdilutenitricacidhasbeenfoundtobesuitable. NOTE ThemethodhasbeenwrittenforthesupportsshowninFigureC.1ofprEN11861:2002whichhavebeenfoundto besuitableforholdingthinfilmandsheettestpieces.Howeverothersupportscanbeusedprovidingtheyarecapableof 1 Theso
43、urceofthisistheChemicalAbstractspublishedbytheAmericanChemicalSocietyEN118614:2002(E) 6 holdingandkeepingthetestpiecesapartandatthesametimeensuringcompletecontactwiththetestmedium.Forrigid samples,supportswithasinglecrossarmcanbeused. 3.3.9 Gauze,piecesoffinestainlesssteelgauze,withameshsizeof1mmhavebeenfoundtobesuitable, approximately25mm 100mmor,glassrods,2mmto3mmindiameterandapproximately100mmlongfor insertionbetweenthetestpieces.Beforeiniti
