1、BRITISH STANDARD BS EN 1186-15:2002 Materials and articles in contact with foodstuffs Plastics Part 15: Alternative test methods to migration into fatty food simulants by rapid extraction into iso-octane and/or 95 % ethanol The European Standard EN 1186-15:2002 has the status of a British Standard I
2、CS 67.250 BS EN 1186-15:2002 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 14 October 2002 BSI 14 October 2002 ISBN 0 580
3、40571 0 National foreword This British Standard is the official English language version of EN 1186-15:2002. The UK participation in its preparation was entrusted by Technical Committee CW/47, Materials and articles in contact with foodstuffs, to Subcommittee CW/47/1, Migration from plastics, which
4、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 found in the BSI Catalogue under the sect
5、ion 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 include all the necessary provisions of a contract. Users are responsible for its correct application. C
6、ompliance 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 enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor rel
7、ated 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 17 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued.
8、 Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN118615 September2002 ICS67.250 Englishversion MaterialsandarticlesincontactwithfoodstuffsPlasticsPart 15:Alternativetestmethodstomigrationintofattyfood simulantsbyrapidextractionintoisooctanea
9、nd/or95% ethanol Matriauxetobjetsencontactaveclesdenres alimentairesMatireplastiquePartie15:Mthodes dessaialternativespourlamigrationdanslessimulants alimentairesgrasparextractionrapidedanslisooctane et/oulthanol95% WerkstoffeundGegenstndeinKontaktmitLebensmitteln KunststoffeTeil15:AlternativePrfver
10、fahrenzur MigrationinfettigePrflebensmitteldurchSchnellextraktion inIsoOctanund/oder95%igesEthanol ThisEuropeanStandardwasapprovedbyCENon29April2002. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardw
11、ithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityo
12、faCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain,Sweden,Switzerl
13、andandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2002CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN118615:2002EEN118615:2002(E) 2 Conten
14、ts page Foreword3 1 Scope 4 2 Normativereferences 5 3 MethodAAlternativetestmethodtomigrationintofattyfoodsimulantsbyrapidextraction intoisooctaneand/or95%ethanolbytotalimmersion . 5 4 MethodBAlternativetestmethodtomigrationintofattyfoodsimulantsbyrapidextraction intoisooctaneand/or95%ethanolinthesi
15、nglesidemodebycell.10 AnnexZA (informative) RelationshipofthisEuropeanStandardwithCouncilDirective89/109/EEC andCommissionDirective90/128/EECandassociatedDirectives15 Bibliography 17EN118615:2002(E) 3 Foreword ThisdocumentEN118615:2002hasbeenpreparedbyTechnicalCommitteeCEN/TC194“Utensilsincontact wi
16、thfood”,thesecretariatofwhichisheldbyBSI. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextor byendorsement,atthelatestbyMarch2003,andconflictingnationalstandardsshallbewithdrawnatthelatestby March2003. ThisEuropeanStandardhasbeenpreparedasoneofaseries
17、ofmethodsoftestforplasticsmaterialsandarticles incontactwithfoodstuffs. ForrelationshipwithEUDirective(s),seeinformativeannexZA,whichisanintegralpartofthisdocument. AtthetimeofpreparationandpublicationofthisstandardtheEuropeanUnionlegislationrelatingtoplastics materialsandarticlesintendedtocomeintoc
18、ontactwithfoodstuffsisincomplete.FurtherDirectivesand amendmentstoexistingDirectivesareexpectedwhichcouldchangethelegislativerequirementswhichthis standardsupports.Itisthereforestronglyrecommendedthatusersofthisstandardrefertothelatestrelevant publishedDirective(s)beforecommencementofanyofthetestort
19、estsdescribedinthisstandard. EN118615shouldbereadinconjunctionwithEN11861. Furtherpartsofthisstandardhavebeenpreparedconcernedwiththedeterminationofoverallmigrationfrom plasticsmaterialsintofoodsimulants.Theirtitlesareasfollows: EN1186MaterialsandarticlesincontactwithfoodstuffsPlastics Part1 Guideto
20、theselectionofconditionsandtestmethodsforoverallmigration Part2 Testmethodsforoverallmigrationintooliveoilbytotalimmersion Part3 Testmethodsforoverallmigrationintoaqueousfoodsimulantsbytotalimmersion Part4 Testmethodsforoverallmigrationintooliveoilbycell Part5 Testmethodsforoverallmigrationintoaqueo
21、usfoodsimulantsbycell Part6 Testmethodsforoverallmigrationintooliveoilusingapouch Part7 Testmethodsforoverallmigrationintoaqueousfoodsimulantsusingapouch Part8 Testmethodsforoverallmigrationintooliveoilbyarticlefilling Part9 Testmethodsforoverallmigrationintoaqueoussimulantsbyarticlefilling Part10 T
22、estmethodsforoverallmigrationintooliveoil(modifiedmethodforuseincaseswhere incompleteextractionofoliveoiloccurs) Part11 Testmethodsforoverallmigrationintomixturesof 14 Clabelledsynthetictriglyceride Part12 Testmethodsforoverallmigrationatlowtemperatures Part13 Testmethodforoverallmigrationathightemp
23、eratures Part14 Testmethodsforsubstitutetestsforoverallmigrationfromplasticsintendedtocomeinto contactwithfattyfoodstuffsusingtestmediaisooctaneand95%ethanol AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowing countriesareboundtoimplementthisEuropeanStandard:
24、Austria,Belgium,CzechRepublic,Denmark,Finland, France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain, Sweden,SwitzerlandandtheUnitedKingdom.EN118615:2002(E) 4 1Scope ThisEuropeanStandardspecifiestwoalternativetestmethods,inthesenseofanextractiontestwithamore
25、severetestcharacter,fortheassessmentoftheoverallmigrationintofattyfoodsimulants. MethodAisbasedonthedeterminationoftheextractionofmigrateablesubstancesfromplasticswhichare intendedtocomeintocontactwithfoodstuffs,bytotalimmersioninnonpolar,isooctane,and/orpolar,ethanol, solventsdependingonthepolarity
26、ofthepackagingmaterial.Accordingtoresultsobtainedbythismethod(see 1,2,3,4,5)andtakingphysiochemicalconsiderationsintoaccount,theobtainedextractionefficiencyhas, generally,beenfoundtobeequivalenttoorhigherthanoverallmigrationresultsobtainedunderthetestconditions, 10daysat40C,2hat70C,1hat100C,30minat1
27、21Cand30minat130C. Toensureascompleteaspossibleextractionofthepotentialmigrants,astronginteraction,e.g.swelling,ofthe samplebytheextractionsolventisnecessary.Forthispurpose,isooctaneisusedasanextractionsolventfor plasticsmaterialsandarticlescontainingnonpolarfoodcontactlayers,suchaspolyolefins.Forte
28、stsamplesmade frompolarfoodcontactplasticssuchaspolyamideandpolyethyleneterephthalate,95%(v/v)aqueousethanolis used.Forpolystyrenes,plasticizedpolyvinylchlorideandotherpolymerswheretheidentificationorpolarityofthe polymerisnotclear,twoparallelextractiontestsshouldbeconductedusingbothoftheproposedext
29、raction solventsandtakingthehighervalueobtainedastherelevantresult. NOTE1 Incaseofmultilayerstructuressuchasplasticslaminatesandcoextrudedplastics,thenatureofthefoodcontact layerdeterminestheselectionoftheextractionsolvent(s). Thistestmethodshouldonlybeappliedtoflexiblepackagingswhicharelessthan300m
30、inthickness.Whenthe resultdoesnotexceedtheallowedoverallmigrationlimitthenthematerialcanbeconsideredtobeincompliance withECregulations.Ifthetestresultexceedstheallowedoverallmigrationlimitthefollowingoptionsmaybe appliedchronologicallywithrespecttofurthermigrationtesting: 1)singlesidedextractiontest
31、usingacell,iftechnicallyfeasible(seeclause4MethodBofthisstandard); 2)conventionalmigrationtestusingoliveoilorotherfattyfoodsimulants; NOTE2 TheoverallmigrationlimitisspecifiedinCommissionDirective90/128/EEC7andtheconditionsoftestinCouncil Directive82/711/EEC8anditssubsequentamendments,9,10. MethodBi
32、sapplicableinthosecaseswherethetotalimmersiontest,EN118615MethodA,yieldstotalextraction valuesthatexceedtheoverallmigrationormaybetechnicallyunsuitable,i.e.inthecaseofmultilayerstructures, suchasplasticslaminatesandcoextrudedfilms.Thistestmethodshouldprimarilyonlybeappliedtoflexible packagingswithap
33、hysicalbarrierlayer(forinstanceofaluminiumorothermaterialtopreventpenetrativelossof extractionsolvent)andwhichhaveathinnerfoodcontactlayerthan300m.Iftheresultdoesnotexceedthe allowedoverallmigrationlimitthenthematerialcanbeconsideredtobeincompliancewithECregulations.Ifthe testresultexceedstheallowed
34、overallmigrationlimitthenthefollowingoptionmaybeappliedwithrespectto furthermigrationtesting: conventionalmigrationtestusingoliveoilorotherfattyfoodsimulants. NOTE3 MethodsAandBarenotapplicabletotestmaterialsintendedforapplicationsover130C. NOTE4 Testmaterialsintendedforapplicationsover70Cshouldbech
35、eckedfortheirphysicalsuitabilityattheintended timeandtemperatureofuse.EN118615:2002(E) 5 2 Normativereferences ThisEuropeanStandardincorporatesbydatedandundatedreference,provisionsfromotherpublications.These normativereferencesarecitedattheappropriateplacesinthetext,andthepublicationsarelistedhereaf
36、ter.For datedreferences,subsequentamendmentstoandrevisionsofanyofthesepublicationsapplytothisEuropean Standardonlywhenincorporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionofthe publicationreferredtoapplies(includingamendments). EN11861:2002, Materialsandarticlesincontactwithfood
37、stuffsPlasticsPart1:Guidetotheselectionof conditionsandtestmethodsforoverallmigration . ISO648, LaboratoryglasswareOnemarkpipettes . ISO4788, LaboratoryglasswareGraduatedmeasuringcylinders . 3Method A Alternativetestmethodtomigrationintofattyfoodsimulantsbyrapidextractionintoiso octaneand/or95%ethan
38、olbytotalimmersion 3.1Principle Themigrateablesubstancesextractedfromasampleoftheplasticsisdeterminedasthemassofnonvolatile residueafterevaporationofthesolventfollowingimmersion.Testspecimensofatleast1dm(singleside considered)areimmersedintheextractionsolventfor24hat40Cor50Candthenremoved.Theextract
39、ion solventisevaporatedtodryness,themassofthenonvolatileresidueisdeterminedandexpressedasmilligrams persquaredecimetreofsurfaceareaofthetestspecimen.ThemeasuredvalueiscomparedtotheECofficial overallmigrationlimitandtakingtheanalyticaltoleranceofthismethod(1mg/dm)intoaccount. 3.2Reagents NOTE Fordeta
40、ilsofpreparationandqualityofthesereagents,seeclause5ofEN11861:2002. 3.2.1Ethanol 95%(v/v)inaqueoussolution. 3.2.2 Isooctane(2,2,4trimethylpentane) NOTE Theextractionsolventsgivenin3.2.1and3.2.2areselectedaccordingtothenatureofthepolymertestsampleas givenbyTable1,see3.5.1.EN118615:2002(E) 6 3.3Appara
41、tus 3.3.1Cutting slab, cleansmoothglass,metalorplasticsslabofsuitableareatopreparetestspecimens, 250mm 250mmissuitable. 3.3.2Tweezers, stainlesssteel,bluntnosed. 3.3.3 Cuttingimplement, scalpel,scissorsorsharpknifeorothersuitabledevice. 3.3.4 Metaltemplate, (100mm0,2mm) (100mm0,2mm)(square). 3.3.5 R
42、ule,graduatedinmm,andwithanaccuracyof0,1mm. 3.3.6 Analyticalbalance capableofdeterminingachangeinmassof0,1mg. 3.3.7Extraction containers; glassweighingjarswithgroundjoints,tallform,ofacapacityofapprox.60ml. 3.3.8 Thermostaticallycontrolledovenorincubator capableofmaintainingatemperaturewithintherang
43、eof +40Cto+50Candmeetingtemperaturetolerancevalueswithinthosespecifiedforthetesttemperature,see annexBofEN11861:2002. WARNING Theinterior/samplespaceoftheovenorincubatorshouldnothaveanyexposedheatingelements,tominimise safetyhazardsarisingfromanylossofflammabletestmediaduringthetestperiod. 3.3.9Dishes, ofstainlesssteel,nickel,platinum,platinumalloyorgold,50mmto90mmdiameterandof maximummass100g,foreva
