1、BRITISH STANDARD BS EN 1186-7:2002 Materials and articles in contact with foodstuffs Plastics Part 7: Test methods for overall migration into aqueous food simulants using a pouch The European Standard EN 1186-7:2002 has the status of a British Standard ICS 67.250 NO COPYING WITHOUT BSI PERMISSION EX
2、CEPT AS PERMITTED BY COPYRIGHT LAWBS EN 1186-7:2002 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 2
3、002 ISBN 0 580 39751 3 National foreword This British Standard is the official English language version of EN 1186-7:2002. It supersedes DD ENV 1186-7:1994 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CW/47, Materials in contact with food, to Subco
4、mmittee 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
5、may be 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 Britis
6、h Standards 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, a
7、nd 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 15 and a back cover. The BSI copyright date displayed in this documen
8、t indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN11867 April2002 ICS67.250 SupersedesENV11867:1994 Englishversion MaterialsandarticlesincontactwithfoodstuffsPlasticsPart 7:Testmethodsforoverallmi
9、grationintoaqueousfood simulantsusingapouch Matriauxetobjetsencontactaveclesdenres alimentairesMatireplastiquePartie7:Mthodes dessaipourlamigrationglobaledanslesliquides simulateursaqueuxlaidedunsachet WerkstoffeundGegenstndeinKontaktmitLebensmitteln KunststoffeTeil7:PrfverfahrenderGesamtmigrationin
10、 wssrigePrflebensmittelmiteinemBeutel ThisEuropeanStandardwasapprovedbyCENon4January2002. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreference
11、sconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentr
12、ehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COM
13、ITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2002CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN11867:2002EEN11867:2002(E) 2 Contents page Foreword3 1 Scope 5 2 Normativereferences 5 3 Principl
14、e5 4 Reagents.5 5 Apparatus .6 6 Preparationoftestspecimens. .6 7 Procedure .7 8 Expressionofresults . .9 9 Testreport . .10 AnnexA (informative) Exampleofapouchholder .11 AnnexB (informative) Precisiondata .12 AnnexZA (informative) RelationshipofthisEuropeanStandardwithCouncilDirective89/109/EEC an
15、dCommissionDirective90/128/EECandassociatedDirectives13 Bibliography 15EN11867:2002(E) 3 Foreword ThisDocumentEN11867:2002hasbeenpreparedbyTechnicalCommitteeCEN/TC194“Utensilsincontactwith food”,thesecretariatofwhichisheldbyBSI. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypu
16、blicationofanidenticaltextor byendorsement,atthelatestbyOctober2002,andconflictingnationalstandardsshallbewithdrawnatthelatest byOctober2002. ThisdocumentsupersedesENV11867:1994. ThisEuropeanStandardisoneofaseriesofmethodsoftestforplasticsmaterialsandarticlesincontactwith foodstuffs. Thisdocumenthas
17、beenpreparedunderamandategiventoCENbytheEuropeanCommissionandtheEuropean FreeTradeAssociation,andsupportsessentialrequirementsofECDirective(s). ForrelationshipwithECDirective(s),seeinformativeannexZA,whichisanintegralpartofthisdocument. AtthetimeofpreparationandpublicationofthisstandardtheEuropeanUn
18、ionlegislationrelatingtoplastics materialsandarticlesintendedtocomeintocontactwithfoodstuffsisincomplete.FurtherDirectivesand amendmentstoexistingDirectivesareexpectedwhichcouldchangethelegislativerequirementswhichthis standardsupports.Itisthereforestronglyrecommendedthatusersofthisstandardrefertoth
19、elatestrelevant publishedDirective(s)beforecommencementofanyofthetestortestsdescribedinthisstandard. EN11867:2002shouldbereadinconjunctionwithEN11861:2002. FurtherPartsofthisstandardhavebeenprepared,andothersareinpreparation,concernedwiththedetermination ofoverallmigrationfromplasticsmaterialsintofo
20、odsimulants. Theirtitlesareasfollows: EN1186MaterialsandarticlesincontactwithfoodstuffsPlastics Part1 Guidetotheselectionofconditionsandtestmethodsforoverallmigration Part2 Testmethodsforoverallmigrationintooliveoilbytotalimmersion Part3 Testmethodsforoverallmigrationintoaqueousfoodsimulantsbytotali
21、mmersion Part4 Testmethodsforoverallmigrationintooliveoilbycell Part5 Testmethodsforoverallmigrationintoaqueousfoodsimulantsbycell Part6 Testmethodsforoverallmigrationintooliveoilusingapouch Part8 Testmethodsforoverallmigrationintooliveoilbyarticlefilling Part9 Testmethodsforoverallmigrationintoaque
22、ousfoodsimulantsbyarticlefilling Part10 Testmethodsforoverallmigrationintooliveoil(modifiedmethodforuseincaseswhere incompleteextractionofoliveoiloccurs) Part11 Testmethodsforoverallmigrationintomixturesof 14 Clabelledsynthetictriglyceride Part12 TestmethodsforoverallmigrationatlowtemperaturesEN1186
23、7:2002(E) 4 Part13 Testmethodsforoverallmigrationathightemperatures Part14 Testmethodsforsubstitutetestsforoverallmigrationfromplasticsintendedtocomeinto contactwithfattyfoodstuffsusingtestmediaisooctaneand95%ethanol Part15 Alternativetestmethodstomigrationintofattyfoodsimulantsbyrapidextractioninto
24、iso octaneand/or95%ethanol AnnexesAandBareinformative. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowing countriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,CzechRepublic,Denmark,Finland, France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,M
25、alta,Netherlands,Norway,Portugal,Spain, Sweden,SwitzerlandandtheUnitedKingdom.EN11867:2002(E) 5 1Scope ThisPartofthisEuropeanStandardspecifiestestmethodsforthedeterminationoftheoverallmigrationinto aqueousbasedfoodsimulantsfromplasticswhichareintendedtocomeintocontactwithfoodstuffs,byformingthe plas
26、ticsfilmorsheetintostandardpouchesandfillingwithaselectedfoodsimulantattesttemperaturesuptoand including70 Cforselectedtesttimes. Thismethodismostsuitableforplasticsintheformoffilmsandsheetswhicharesealablebyheatorpressure. Thetestisparticularlyapplicabletothosematerialsconsistingofmorethanonelayer,
27、whicharetestedwiththe foodsimulantincontactonlywiththesurfacewhichisintendedtobeincontactwiththefoodstuffs. Astandardpouchisapouchwiththedimensionsasdescribedin6.3. NOTE Pouchesofdimensionsotherthan10cm 10cmcanbeusedfortesting.Thesepouchesshouldbeprepared wherepossiblesothatthetotalsurfaceareaexpose
28、disnotlessthan1dm. 2 Normativereferences ThisEuropeanStandardincorporatesbydatedandundatedreference,provisionsfromotherpublications.These normativereferencesarecitedattheappropriateplacesinthetext,andthepublicationsarelistedhereafter.For datedreferences,subsequentamendmentstoandrevisionsofanyofthese
29、publicationsapplytothisEuropean Standardonlywhenincorporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthe publicationreferredtoapplies(includingamendments). EN11861:2002, MaterialsandarticlesincontactwithfoodPlasticsPart1:Guidetotheselectionofconditions andtestmethodsforoverall
30、migration . ISO648, LaboratoryglasswareOnemarkpipettes . ISO4788, LaboratoryglasswareGraduatedmeasuringcylinders. 3Principle Theoverallmigrationofnonvolatilesubstancesfromasampleoftheplasticsisdeterminedasthemassofnon volatileresidueafterevaporationofthefoodsimulant,seeclauses4,5and5ofEN11861:2002.
31、Testspecimensintheformofpouchesarefilledwiththeaqueousfoodsimulantfortheexposuretimeat temperaturesuptoandincluding70 C.Attheendofthetestperiod,thefoodsimulantisremovedfromeachtest specimen.Thefoodsimulantfromeachtestspecimenisevaporatedtodryness,themassofthenonvolatile residueisdeterminedandexpress
32、edasmilligramspersquaredecimetreofsurfaceareaoftestspecimen. NOTE Insomecircumstancestheproceduredescribedinthisstandardcanbeusedforexposureattemperaturesabove 70 C. Overallmigrationisreportedasthemeanofthreedeterminationsonseparatetestspecimens. 4Reagents NOTE Fordetailsofthepreparationandpurityoft
33、hesereagentsseeclause4ofEN11861:2002. 4.1 Distilledwaterorwaterofequivalentquality(simulantA) 4.2 Aceticacid3%(w/v)inaqueoussolution(simulantB)EN11867:2002(E) 6 4.3 Ethanol10%(v/v)inaqueoussolution(simulantC) 4.4 Alcoholicsimulantsforliquidsorbeveragesofanalcoholicstrengthexceeding10%(v/v). NOTE Int
34、hecaseofmaterialsandarticlesintendedtocomeintocontactwithliquidsorbeveragesofanalcoholicstrength exceeding10%(v/v),thetestcanbecarriedoutwithaqueoussolutionsofethanolofasimilarstrength. 5Apparatus 5.1 Cuttingslab,cleansmoothglass,metalorplasticsslabofsuitableareatopreparetestspecimens, 250mm 250mmis
35、suitable. 5.2 Tweezers,stainlesssteel,bluntnosed. 5.3 Cuttingimplement,scalpel,scissorsorsharpknifeorothersuitabledevice. 5.4 Rule,graduatedinmm,andwithanaccuracyof0,1mm. 5.5 Metaltemplate(120mm 1mm) (120mm+1mm)(square). 5.6 Analyticalbalancecapableofdeterminingachangeinmassof0,1mg. 5.7 Pouchholder,
36、theexampleshowninFigureA.1hasbeenshowntobesuitable,constructedfromaluminium orothersuitablematerialoranequivalentholder,plusclipstosecurecornersofpouches. 5.8 Pipettes,complyingwiththeminimumrequirementsofISO648,50mland100ml. 5.9 Glasstubes,groundneck,andstoppers,forretainingthefoodsimulant.Tubeswit
37、haninternaldiameterof approximately35mmandlengthintherangeof100mmto200mm,excludingthegroundneck,(see7.2of EN11861:2002)havebeenfoundtobesatisfactory. 5.10 Thermostaticallycontrolledovenorincubatororrefrigeratorcapableofmaintainingthesettemperature withinthetolerancesspecifiedinTableB.2ofEN11861:2002
38、. 5.11 Dishes,stainlesssteel,nickel,platinum,platinumalloy,gold50mmto90mmdiameterandmaximummass 100g,forevaporationoffoodsimulantsandweighingofresidues.Glass,glassceramicorceramicdishesmaybe usedprovidedthatthesurfacecharacteristicsaresuchthatthemassesofthedishesafterevaporationofany specifiedfoodsi
39、mulantsfollowedbyconditioninginthedesiccatorusedachievesaconstancyof 0,5mg. Stainlesssteelandnickeldishesaresuitableonlyfordistilledwaterandethanolsolutions.Glass,glassceramic, glazedceramic,platinum,platinumalloyorgolddishesaresuitableforallthreesimulants. 5.12 Steambath,hotplate,distillationappara
40、tusorrotaryevaporatorforevaporationoffoodsimulantattheend oftestperiod. 5.13 Desiccatorwithanhydrouscalciumchlorideorselfindicatingsilicagel. 5.14 Heatorpressuresealingdevice,foruseinformingpouches. 5.15 Measuringcylinders,100ml,complyingwiththeminimumrequirementsofISO4788. 6 Preparationoftestspecim
41、ens 6.1General Itisessentialthattestspecimensarecleanandfreefromsurfacecontamination(manyplasticscanreadilyattract dustduetostaticcharges).Beforepreparingtestspecimens,removeanysurfacecontaminationfromthesample bygentlywipingitwithalintfreecloth,orbybrushingwithasoftbrush.Undernocircumstanceswashthe
42、sampleEN11867:2002(E) 7 withwaterorsolvent.Ifitisspecifiedintheinstructionsforuseofthearticlethatitshouldbewashedorcleaned beforeusesee8.1ofEN11861:2002.Minimizehandlingofthesamplesandwherenecessary,wearcotton gloves. 6.2 Numberoftestspecimens Threetestspecimensarerequired. 6.3 Cuttingandpreparation
43、ofspecimens Laythesampleonthecuttingslab(5.1)withthesurfacetobeincontactwiththefoodsimulantuppermostandcut thetestspecimensusingthe120mm 120mmtemplate(5.5). Placepairsofthetestpiecestogetherwiththesurfacestobeincontactwiththefoodsimulantfacing.Usingthe heatorpressuresealer(5.14),jointoformpoucheswithfoursealsparalleltoallfouredges,10mmfromtheedge. Measurethedistancesbetweentheinneredgesofthesealstothenearest1mmandcalculatethetotalsurface areaofthetestspecimenwhichwillbeexposedtothefoodsimulant
