1、BRITISH STANDARD BS EN 1186-5:2002 Materials and articles in contact with foodstuffs Plastics Part 5: Test methods for overall migration into aqueous food simulants by cell The European Standard EN 1186-5:2002 has the status of a British Standard ICS 67.250 NO COPYING WITHOUT BSI PERMISSION EXCEPT A
2、S PERMITTED BY COPYRIGHT LAWBS EN 1186-5:2002 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 21 May 2002 BSI 21 May 2002 IS
3、BN 0 580 39754 8 National foreword This British Standard is the official English language version of EN 1186-5:2002. It supersedes DD ENV 1186-5:1994 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CW/47, Materials in contact with food, to Subcommitte
4、e 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 or European publications referred to in this document may be
5、 found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Stan
6、dards are responsible for their 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 European committee any enquiries on the interpretation, or proposals for change, and kee
7、p 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 13 and a back cover. The BSI copyright date displayed in this document indi
8、cates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN11865 April2002 ICS67.250 SupersedesENV11865:1994 Englishversion MaterialsandarticlesincontactwithfoodstuffsPlasticsPart 5:Testmethodsforoverallmigratio
9、nintoaqueousfood simulantsbycell Matriauxetobjetsencontactaveclesdenres alimentairesMatireplastiquePartie5:Mthodes dessaipourlamigrationglobaledanslesliquides simulateursaqueuxencellule WerkstoffeundGegenstndeinKontaktmitLebensmitteln KunststoffeTeil5:Prfverfahrenfrdie GesamtmigrationinwssrigenPrfle
10、bensmittelnmittels Zellen ThisEuropeanStandardwasapprovedbyCENon4January2002. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings
11、 uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesames
12、tatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDEN
13、ORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2002CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN11865:2002EEN11865:2002(E) 2 Contents page Foreword3 1 Scope 5 2 Normativereferences 5 3 Principle5 4 Reagent
14、s.5 5 Apparatus .6 6 Preparationoftestspecimens. .7 7 Numberoftestspecimens 7 8 Procedure .7 9 Expressionofresults . .9 10 Testreport 9 AnnexA (informative) Precisiondata .10 AnnexZA (informative) RelationshipofthisEuropeanStandardwithCouncilDirective89/109/EEC andCommissionDirective90/128/EECandass
15、ociatedDirectives11 Bibliography 13EN11865:2002(E) 3 Foreword ThisdocumentEN11865:2002hasbeenpreparedbyTechnicalCommitteeCEN/TC194“Utensilsincontactwith food”,thesecretariatofwhichisheldbyBSI. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextor byendor
16、sement,atthelatestbyOctober2002,andconflictingnationalstandardsshallbewithdrawnatthelatest byOctober2002. ThisdocumentsupersedesENV11865:1994. ThisEuropeanStandardisoneofaseriesofmethodsoftestforplasticsmaterialsandarticlesincontactwith foodstuffs. ThisdocumenthasbeenpreparedunderamandategiventoCENb
17、ytheEuropeanCommissionandtheEuropean FreeTradeAssociation,andsupportsessentialrequirementsofECDirective(s). ForrelationshipwithECDirective(s),seeinformativeannexZA,whichisanintegralpartofthisdocument. AtthetimeofpreparationandpublicationofthisstandardtheEuropeanUnionlegislationrelatingtoplastics mat
18、erialsandarticlesintendedtocomeintocontactwithfoodstuffsisincomplete.FurtherDirectivesand amendmentstoexistingDirectivesareexpectedwhichcouldchangethelegislativerequirementswhichthis standardsupports.Itisthereforestronglyrecommendedthatusersofthisstandardrefertothelatestrelevant publishedDirective(s
19、)beforecommencementofanyofthetestortestsdescribedinthisstandard. EN11865shouldbereadinconjunctionwithEN11861. FurtherPartsofthisstandardhavebeenpreparedconcernedwiththedeterminationofoverallmigrationfrom plasticsmaterialsintofoodsimulants.Theirtitlesareasfollows: EN1186Materialsandarticlesincontactw
20、ithfoodstuffsPlastics Part1 Guidetotheselectionofconditionsandtestmethodsforoverallmigration Part2 Testmethodsforoverallmigrationintooliveoilbytotalimmersion Part3 Testmethodsforoverallmigrationintoaqueousfoodsimulantsbytotalimmersion Part4 Testmethodsforoverallmigrationintooliveoilbycell Part6 Test
21、methodsforoverallmigrationintooliveoilusingapouch Part7 Testmethodsforoverallmigrationintoaqueousfoodsimulantsusingapouch Part8 Testmethodsforoverallmigrationintooliveoilbyarticlefilling Part9 Testmethodsforoverallmigrationintoaqueousfoodsimulantsbyarticlefilling Part10 Testmethodsforoverallmigratio
22、nintooliveoilmodifiedmethodforuseincaseswhere incompleteextractionofoliveoiloccurs) Part11 Testmethodsforoverallmigrationintomixturesof 14 Clabelledsynthetictriglyceride Part12 TestmethodsforoverallmigrationatlowtemperaturesEN11865:2002(E) 4 Part13 Testmethodsforoverallmigrationathightemperatures Pa
23、rt14 Testmethodsforsubstitutetestsforoverallmigrationfromplasticsintendedtocomeinto contactwithfattyfoodstuffsusingtestmediaisooctaneand95%ethanol Part15 Alternativetestmethodstomigrationintofattyfoodsimulantsbyrapidextractionintoiso octaneand/or95%ethanol AnnexAisinformative. AccordingtotheCEN/CENE
24、LECInternalRegulations,thenationalstandardsorganizationsofthefollowing countriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,CzechRepublic,Denmark,Finland, France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain, Sweden,SwitzerlandandtheUnitedKingdom
25、.EN11865:2002(E) 5 1Scope ThisPartofthisEuropeanStandardspecifiestestmethodsforthedeterminationoftheoverallmigrationinto aqueousbasedfoodsimulantsfromonesurfaceonlyofplastics,whichareintendedtocomeintocontactwith foodstuffs,byexposingthefoodcontactsurface,usingacell,totheselectedfoodsimulantattemper
26、aturesupto andincluding70 Cforselectedtesttimes. Thismethodismostsuitableforplasticsintheformoffilmsandsheets,butisparticularlyapplicabletothose materialsconsistingofmorethanonelayerorofsurfacesthatdifferintheirmigrationcharacteristics,whichshould betestedwiththefoodsimulantincontactonlywiththesurfa
27、cewhichisintendedtocomeintocontactwith foodstuffs. 2 Normativereferences ThisEuropeanStandardincorporatesbydatedandundatedreference,provisionsfromotherpublications.These normativereferencesarecitedattheappropriateplacesinthetext,andthepublicationsarelistedhereafter.For datedreferences,subsequentamen
28、dmentstoandrevisionsofanyofthesepublicationsapplytothisEuropean Standardonlywhenincorporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthe publicationreferredtoapplies(includingamendments). EN11861:2002, MaterialsandarticlesincontactwithfoodstuffsPlasticsPart1:Guidetotheselectio
29、nof conditionsandtestmethodsforoverallmigration. ISO648, LaboratoryglasswareOnemarkpipettes. ISO4788, LaboratoryglasswareGraduatedmeasuringcylinders. 3Principle Theoverallmigrationofnonvolatilesubstancesfromasampleoftheplasticsisdeterminedasthemassofnon volatileresidueafterevaporationofthefoodsimula
30、nt. Theselectionoftheconditionsoftestandthefoodsimulant(s)willbedeterminedbytheconditionsofuse,see clauses4,5and6ofEN11861:2002. Testspecimensofapproximately2,5dmareexposedinacelltothefoodsimulantfortheexposuretimeat temperaturesuptoandincluding70 C.Attheendofthetestperiod,eachtestspecimenisremovedf
31、romthecell. Thefoodsimulantfromeachtestspecimenisevaporatedtodryness,themassofthenonvolatileresidueis determinedgravimetricallyandexpressedasmilligramspersquaredecimetreofsurfaceareaoftestspecimen. NOTE Insomecircumstancestheproceduredescribedinthisstandardcanbeusedforexposureattemperaturesabove 70
32、C. Overallmigrationisreportedasthemeanofthreedeterminationsonseparatetestspecimens. 4Reagents NOTE Fordetailsofthepreparationandpurityofthesereagentsseeclause4ofEN11861:2002. 4.1 Distilledwaterorwaterofequivalentquality(simulantA) 4.2 Aceticacid3%(w/v)inaqueoussolution(simulantB)EN11865:2002(E) 6 4.
33、3 Ethanol10%(v/v)inaqueoussolution(simulantC) 4.4 Alcoholicsimulantsforliquidsorbeveragesofanalcoholicstrengthexceeding10%(v/v). NOTE Inthecaseofmaterialsandarticlesintendedtocomeintocontactwithliquidsorbeveragesofanalcoholicstrength exceeding10%(v/v)thetestiscarriedoutwithaqueoussolutionsofethanolo
34、fasimilarstrength. 5Apparatus 5.1 Cuttingslab,cleansmoothglass,metalorplasticsslabofsuitableareatopreparetestspecimens, 250mm 250mmissuitable. 5.2 Tweezers,stainlesssteel,bluntnosed. 5.3 Cuttingimplement,scalpel,scissorsorsharpknifeorothersuitabledevice. 5.4 Rule,graduatedinmillimetres,andwithanaccu
35、racyof0,1mm. 5.5 Analyticalbalancecapableofdeterminingachangeinmassof0,1mg. 5.6 Cells,typeAasshowninFigureC.3ofEN11861:2002,eithertheallaluminium(anodized)cellsorthecells withthestainlesssteel(316grade)lidsandrings,aresuitableforthewaterandaqueousethanolfoodsimulants. Fortheaqueousaceticacidfoodsimu
36、lantthecellswiththestainlesssteellidsandringsareused.Theinternal diameteroftherimofthesealingringshallbe178,4mm 0,1mm,togiveanareaofthetestspecimenexposedto thefoodsimulantof2,5dm. NOTE Thecells,typeA,areconstructedwitharubbermatinthebaseplate.Whenusingthecellswitheitherthewateror aqueousethanolfood
37、simulantsitisadvisedthatadiscofaluminiumfoilisplacedonthematbeforeinsertingthetest specimen.Fortheaqueousaceticacidfoodsimulantadiscofpolytetrafluoroethyleneorothersuitablematerialwhichisiner tto aceticacidcanbeused.Theuseofthesediscswillpreventanysubstancesfromthematinfluencingthemigrationresult. F
38、ordetailsofequivalentcellssee7.3ofEN11861:2002. 5.7 Pipettes,complyingwiththeminimumrequirementsofISO648,50mland100ml. 5.8 Glasstubes,groundneck,andstoppers,forretainingthefoodsimulant.Tubeswithaninternaldiameterof approximately35mmandlengthofapproximately100mmto200mm,excludingthegroundneck(see7.2of
39、EN 11861:2002),havebeenfoundtobesatisfactory. 5.9 Thermostaticallycontrolledovenorincubatororrefrigeratorcapableofmaintainingasettemperaturewithin thetolerancesspecifiedinTableB.2ofEN11861:2002. 5.10 Dishes,stainlesssteel,nickel,platinum,platinumalloy,gold,50mmto90mmdiameterandmaximummass 100g,forev
40、aporationoffoodsimulantsandweighingofresidues.Glass,glassceramicorceramicdishesmaybe used,providedthatthesurfacecharacteristicsaresuchthatthemassesofthedishesafterevaporationofany specifiedfoodsimulantsfollowedbyconditioninginthedesiccatorusedachievesaconstancyof 0,5mg. Stainlesssteelandnickeldishes
41、aresuitableonlyfordistilledwaterandethanolsolutions.Glass,glassceramic, glazedceramic,platinum,platinumalloyorgolddishesaresuitableforallthreesimulants. 5.11 Steambath,hotplate,distillationapparatusorrotaryevaporatorforevaporationoffoodsimulantattheend oftestperiod. 5.12 Desiccatorwithanhydrouscalci
42、umchlorideorselfindicatingsilicagel. 5.13 Measuringcylinders,250ml,complyingwiththeminimumrequirementsofISO4788.EN11865:2002(E) 7 6 Preparationoftestspecimens 6.1General Itisessentialthattestspecimensarecleanandfreefromsurfacecontamination(manyplasticscanreadilyattract dustduetostaticcharges).Before
43、preparingtestspecimens,removeanysurfacecontaminationfromthesample bygentlywipingitwithalintfreecloth,orbybrushingwithasoftbrush.Undernocircumstanceswashthesample withwaterorsolvent.Ifitisspecifiedintheinstructionsforuseofthearticlethatitshouldbewashedorcleaned beforeuse,see8.1ofEN11861:2002.Minimizehandlingofthesamplesandwherenecessary,wearcotton gloves. 7 Numberoftestspecimens Threetestspecimensarerequiredforsamples,intheformofthinfilms,sheets,andflatsectionscutfrom containersorsimilararticles. 7.1 Cutting
