BS EN 1186-5-2002 Materials and articles in contact with foodstuffs - Plastics - Test methods for overall migration into aqueous food simulants by cell《与食品接触的材料和器具 塑料 用电解槽浸渍在含水食品模拟.pdf

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 It supersedes DD ENV 1186-5:1994 which is withdrawn.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