1、DRAFT FOR DEVELOPMENT DD CEN/TS 14234:2002 Materials and articles in contact with foodstuffs Polymeric coatings on paper and board Guide to the selection of conditions and test methods for overall migration ICS 67.250 DD CEN/TS 14234:2002 This Draft for Development was published under the authority
2、of the Standards Policy and Strategy Committee on 30 January 2003 BSI 30 January 2003 ISBN 0 580 41152 4 National foreword This Draft for Development is the English language version of CEN/TS 14234:2002. This publication is not to be regarded as a British Standard. It is being issued in the Draft fo
3、r Development series of publications and is of a provisional nature because of the need to develop a method of test dealing with the coatings of materials and articles in contact with food, in order to satisfy the proposed European legislation. It should be applied on this provisional basis, so that
4、 information and experience of its practical application may be obtained. Comments arising from the use of this Draft for Development are requested so that UK experience can be reported to the European organization responsible for its conversion to a European standard. A review of this publication w
5、ill be initiated 2 years after its publication by the European organization so that a decision can be taken on its status at the end of its 3-year life. Notification of the start of the review period will be made in an announcement in the appropriate issue of Update Standards. According to the repli
6、es received by the end of the review period, the responsible BSI Committee will decide whether to support the conversion into a European standard, to extend the life of the Technical Specification or to withdraw it. Comments should be sent in writing to the Secretary of BSI Subcommittee CW/47/1, Mig
7、ration from plastics, 389 Chiswick High Road, London W4 4AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the text. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The Bri
8、tish Standards which implement international or 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 On
9、line. Summary of pages This document comprises a front cover, an inside front cover, the CEN/TS title page, pages 2 to 26, an inside 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
10、. Date CommentsTECHNICALSPECIFICATION SPCIFICATIONTECHNIQUE TECHNISCHESPEZIFIKATION CEN/TS14234 October2002 ICS67.250 Englishversion MaterialsandarticlesincontactwithfoodstuffsPolymeric coatingsonpaperandboardGuidetotheselectionof conditionsandtestmethodsforoverallmigration Matriauxetobjetsencontact
11、aveclesdenres alimentairesRevtementspolymressurpapieretcarton Guidepourlechoixdesconditionsetdesmthodes dessaienmatiredemigrationglobale WerkstoffeundGegenstndeinKontaktmitLebensmitteln PolymereBeschichtungenaufPapierundPappe LeiftadenfrdieAuswahlvonPrfbedingungenund PrfverfahrenfrdieGesamtmigration
12、 ThisTechnicalSpecification(CEN/TS)wasapprovedbyCENon28July2002forprovisionalapplication. TheperiodofvalidityofthisCEN/TSislimitedinitiallytothreeyears.AftertwoyearsthemembersofCENwillberequested tosubmittheir comments,particularlyonthequestionwhethertheCEN/TScanbeconvertedintoaEuropeanStandard. CEN
13、membersarerequiredtoannouncetheexistenceofthisCEN/TSinthesamewayasforanENandtomaketheCEN/TSavailable .It ispermissibletokeepconflictingnationalstandardsinforce(inparalleltotheCEN/TS)untilthefinaldecisionaboutthep ossible conversionoftheCEN/TSintoanENisreached. CENmembersarethenationalstandardsbodies
14、ofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassa
15、rt,36B1050Brussels 2002CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.CEN/TS14234:2002ECEN/TS14234:2002(E) 2 Contents Foreword3 1 Scope 4 2 Normativereferences 5 3 Testconditions . .5 4 Totalimmersionmethod .6 5 Cellmethod. 9 6 Expressionofresults .
16、.12 7 Testreport . .13 AnnexA (normative) Proposedtestschemeforpaperswithpolymericcoatingsintendedforfattyfood contact. .14 AnnexB (informative) Guidanceformigrationtestingofpolymericcoatingsoncellulosicsubstrates (paperandboard) 15 AnnexZA (informative) RelationshipofthisTechnicalSpecificationwithC
17、ouncilDirective89/109/EEC andassociatedEUDirective(s) . .23 Bibliography 25CEN/TS14234:2002(E) 3 Foreword Thisdocument(CEN/TS14234:2002)hasbeenpreparedbyTechnicalCommitteeCEN/TC 194,“Utensilsin contactwithfood“,thesecretariatofwhichisheldbyBSI. ThisdocumenthasbeenpreparedunderamandategiventoCENbythe
18、EuropeanCommissionandtheEuropean FreeTradeAssociation,andsupportsessentialrequirementsofEUDirective(s). ForrelationshipwithEUDirective(s),seeinformativeannexZA,whichisanintegralpartofthisdocument. InthisstandardtheAnnexAisnormativeandAnnexBisinformative. Guidanceformigrationtestingofpolymericcoating
19、soncellulosicsubstrates(paperandboard)isgiveninthe informativeannexB. AtthetimeofpreparationandpublicationofthisTechnicalSpecificationtheEuropeanUnionlegislationrelatingto resinousandpolymericcoatingsonpaperandboardhasnotbeenformulated. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandar
20、dsorganizationsofthefollowing countriesareboundtoannouncethisTechnicalSpecification:Austria,Belgium,CzechRepublic,Denmark, Finland,France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal, Spain,Sweden,SwitzerlandandtheUnitedKingdom.CEN/TS14234:2002(E) 4 1Scope ThisTe
21、chnicalSpecificationspecifiestestmethodsforalternativetestsandsubstitutetestsperformedwith volatiletestmedia,isooctaneandavolumefractionof95%aqueousethanol,forthedeterminationofoverall migrationfrompolymericcoatingsonpaperandboardintendedtocomeintocontactwithfattyfoodstuffs. NOTE1 Italsoincludesguid
22、ancefortheapplicationofCouncilDirective82/711/EEC1,aslastamendedbyCommission Directives93/8/ECand97/48/EC23asregardsthedeterminationofthespecificandoverallmigrationintofattyfood simulants(fattest)andincludesaglossarytoclarifytheterminologyused,seeannexB. NOTE2 Theisooctaneandavolumefractionof95%aque
23、ousethanolvolatiletestmediausedinthesetestmethodsare thosespecifiedforsubstitutetestsinCouncilDirective82/711/EECanditssubsequentamendments.Inadditiontotheuseof isooctaneand95%v/vaqueousethanolastestmediaforsubstitutetests,CouncilDirective82/711/EECanditssubsequent amendmentsspecifiestheuseofmodifie
24、dpolyphenyleneoxideasatestmediumforuseattemperaturesof100 Candabove. Atestmethodforoverallmigrationfrompolymericcoatingsintendedtocomeintocontactwithfattyfoodstuffsusingmodified polyphenyleneoxide(MPPO)isinpreparation. NOTE3 ThesetestmethodscanalsobeusedforthealternativetestsdescribedinCouncilDirect
25、ive82/711/EECandits subsequentamendments,whenthechosenvolatiletestmediaareisooctaneandavolumefractionof95%aqueousethanol, seeENV11861. AsuggestedtestschemeisgiveninFigureA.1.Ifthetestresultobtainedbythetotalimmersionmethod,described inclause4ofthisTechnicalSpecification,exceedstheallowedoverallmigra
26、tionlimitthesinglesidedmigration testusingacell,seeclause5,iftechnicallyfeasible;maybeused.Ifitisnotpossibletousethesinglesidedcell method,e.g.becauseofpinholes,useadsorptionbymodifiedpolyphenyleneoxide,(MPPO). Isooctaneisusedasatestmediumfortestsamplescoatedwithnonpolarfoodcontactlayers,suchas poly
27、olefins.Fortestsamplescoatedwithpolarfoodcontactpolymerssuchaspolyamideandpolyethylene terephthalate,avolumefractionof95%aqueousethanolisused.Forpolystyrenes,plasticisedpolyvinylchloride andotherpolymerswheretheidentificationorpolarityofthepolymerisnotclear,twoparalleltestsshallbe conductedusingboth
28、oftheproposedtestmediaandtakingthehighervalueobtainedastherelevantresult. NOTE4 Thenatureofthefoodcontactlayerdeterminestheselectionofthetestmedium(a). NOTE5 TheoverallmigrationlimitformaterialsandarticlesofanallpolymericconstructionisspecifiedinCommission Directive90/128/EEC4andtheconditionsoftesti
29、nCouncilDirective82/711/EEC1anditssubsequentamendments,2,3. Thereisanexpectationthatthescopeofthisdirectivewillbeextendedtocoverpolymericcoatingsonpaperandboard. ThesubstitutetestsdescribedinthisTechnicalSpecificationarebytotalimmersion,seeclause4andina migrationcell,seeclause5. NOTE6 Thetestconditi
30、onsarethosedescribedinCouncilDirective82/711/EEC1anditssubsequentamendments, 2,3. Thealternativetestmethodsdescribedherespecifiesarapidextractiontestwithamoreseveretestcharacter, fortheassessmentoftheoverallmigrationintofattyfoodsimulants.Themethoddiffersfromthesubstitutetest methodsonlyinthecombina
31、tionoftesttimeandtesttemperature.Themethodisbasedonthedeterminationof theextractionofmigrateablesubstancesfrompolymericcoatedpaperorboard,whichareintendedtocomeinto contactwithfoodstuffs,bytotalimmersioninnonpolar,isooctane,and/orpolar,ethanol,solventsdependingon thepolarityofthepolymericcoating.Acc
32、ordingtotheresultsobtainedbythismethod,see5,6,7,8,9and takingphysiochemicalconsiderationsintoaccount,theobtainedextractionefficiencyhas,generally,beenfoundto beequivalenttoorhigherthanoverallmigrationresultsobtainedusingfatsimulantD,underthetestconditions,10 daysat40C,2hat70C,1hat100C,30minat121Cand
33、30minat130C. NOTE7 Thismethodisnotapplicabletotestmaterialsintendedforapplicationsover130C.Testmaterialsintendedfor applicationsover70Chavetobecheckedfortheirphysicalsuitabilityattheintendedtimeandtemperatureofuse. Thetestmethodshouldbeappliedtopolymercoatedpackagingswherethepolymerlayerislessthan30
34、0min thickness. However,ifthisextractiontestisappliedtomaterialswithcoatingswithhigherthicknessthan300m andtheresultdoesnotexceedanyallowedoverallmigrationlimitthenthemethodisconsideredtobesuitablefor thosematerials.CEN/TS14234:2002(E) 5 Inthosecaseswheretherapidextractiontestbytotalimmersion,yields
35、totalextractionvaluesthatexceedthe overallmigrationlimitormaybetechnicallyunsuitableacelltestmethodusingthesametimeandtemperature conditionsisapplicable.Thiscelltestmethodshouldprimarilyonlybeappliedtopackagingswithaphysicalbarrier layer(forinstanceofaluminiumorothermaterialtopreventpenetrativelosso
36、ftestmedium)andwhichhavea thinnerfoodcontactlayerthan300m.Thistestmethodcannotbeappliedifthepolymericcoatingisshownto havepinholes. 2 Normativereferences ThisTechnicalSpecificationincorporatesbydatedandundatedreference,provisionsfromotherpublications. Thesenormativereferencesarecitedattheappropriate
37、placesinthetextandthepublicationsarelistedhereafter. Fordatedreferences,subsequentamendmentstoandrevisionsofanyofthesepublicationsapplytothisTechnical Specificationonlywhenincorporatedinitbyamendmentorrevision.Forundatedreferencesthelatesteditionof thepublicationreferredtoapplies(includingamendments
38、). ENV 11861:1994 MaterialsandarticlesincontactwithfoodstuffsPlasticsGuidetotheselectionof conditionsandtestmethodsforoverallmigration ISO648 LaboratoryglasswareOnemarkpipettes ISO4788 LaboratoryglasswareGraduatedmeasuringcylinders 3Test conditions 3.1Substitutetestmethods Forsubstitutetests,thecond
39、itionsoftestwillbedeterminedbytheconditionsofuse,seeclauses4,5and6of ENV11861:1994. 3.2 Alternativetestmethods Foralternativetests,thetestmedium(a)andtestconditionsaretobeselectedaccordingtothenatureofthe polymericcoatingasgivenbyTable1.CEN/TS14234:2002(E) 6 Table1Useoftestmediaandtestconditionsfora
40、lternativetests Polymertypeoffoodcontactlayer Testmediumtobeapplied Testconditionstobeapplied Polyolefinsandcopolymers Polyamides Polystyrene Polyethyleneterephthalate Polyvinylchloride(plasticised) Polyvinylchloride(rigid) Incaseofdoubtorunknown isooctane 95%ethanol isooctaneand95%ethanol 95%ethano
41、l isooctaneand95%ethanol 95%ethanol isooctaneand95%ethanol 24hat40C 24hat40C 24hat40C 24hat50C 24hat40C 24hat50C 24hat50C 4 Totalimmersionmethod 4.1Principle Themigrateablesubstancesextractedfromasampleofthepolymercoatedpaperorboardisdeterminedasthe massofnonvolatileresidueafterevaporationofthesolve
42、ntfollowingimmersion. Testspecimensofatleast1dm(singlesideconsidered)areimmersedinthetestmediumforsetperiodsoftime andatsettemperaturesandthenremoved.Thetestmediumisevaporatedtodryness,themassofthenon volatileresidueisdeterminedandexpressedasmilligramspersquaredecimetreofsurfaceareaofthetest specime
43、n.CEN/TS14234:2002(E) 7 4.2Apparatus 4.2.1 Cuttingslab, cleansmoothglass,metalorplasticsslabofsuitableareatopreparetestspecimens, 250mmx250mmissuitable. 4.2.2Tweezers, stainlesssteel,bluntnosed. 4.2.3 Cuttingimplement, scalpel,scissorsorsharpknifeorothersuitabledevice. 4.2.4 Metaltemplate, 100mm0,2mmx100mm0,2mm(square). 4.2.5Rule, graduatedinmm,andreadabletothenearest0,1mm. 4.2.6 Analyticalbalance, capableofdeterminingachangeinmassof0,1mg. 4.2.7Extraction containers; glassweigh
