1、BRITISH STANDARD BS EN 1186-1:2002 Materials and articles in contact with foodstuffs Plastics Part 1: Guide to the selection of conditions and test methods for overall migration The European Standard EN 1186-1:2002 has the status of a British Standard ICS 67.250 NO COPYING WITHOUT BSI PERMISSION EXC
2、EPT AS PERMITTED BY COPYRIGHT LAWBS EN 1186-1:2002 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 20
3、02 ISBN 0 580 39746 7 National foreword This British Standard is the official English language version of EN 1186-1:2002. It supersedes DD ENV 1186-1:1994 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CW/47, Materials in contact with food, to Subcom
4、mittee 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 m
5、ay 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 British
6、 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, an
7、d 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 49 and a back cover. The BSI copyright date displayed in this document
8、 indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN11861 April2002 ICS67.250 SupersedesENV11861:1994 Englishversion MaterialsandarticlesincontactwithfoodstuffsPlasticsPart 1:Guidetotheselectionofcon
9、ditionsandtestmethodsfor overallmigration Matriauxetobjetsencontactaveclesdenres alimentairesMatireplastiquePartie1:Guidepourle choixdesconditionsetdesmthodesdessaienmatire demigrationglobale WerkstoffeundGegenstndeinKontaktmitLebensmitteln KunststoffeTeil1:LeitfadenfrdieAuswahlder Prfbedingungenund
10、Prfverfahrenfrdie Gesamtmigration ThisEuropeanStandardwasapprovedbyCENon5January2002. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencescon
11、cernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehas
12、thesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEU
13、ROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2002CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN11861:2002EEN11861:2002(E) 2 Contents page Foreword3 Introduction .5 1 Scope 6 2 Normativereferences
14、6 3 Termsanddefinitions. .6 4 Typesoftest. 8 5 Foodsimulants,testmediaandreagents 9 6 Selectionoffoodsimulants. .10 7 Migrationtest,substitutetestandalternativetestconditions . 17 8 Apparatus .22 9 Samplesandsamplegeometry . .23 10 Overallmigrationtestmethodswithfattyfoodsimulants . .27 11 Precision
15、.31 12 Testreports . .32 AnnexA (normative) Characteristicsoffattyfoodsimulantsandtestmedia.35 AnnexB (normative) TolerancesoncontacttimesandcontacttemperaturesapplicabletoallPartsof thisstandard .37 AnnexC (informative) Supportsandcells .39 AnnexZA (informative) RelationshipofthisEuropeanStandardwi
16、thCouncilDirective89/109/EEC andCommissionDirective90/128/EECandassociatedDirectives47 Bibliography 49EN11861:2002(E) 3 Foreword ThisdocumentEN11861:2002hasbeenpreparedbyTechnicalCommitteeCEN/TC194Utensilsincontactwith food,thesecretariatofwhichisheldbyBSI. ThisEuropeanStandardshallbegiventhestatuso
17、fanationalstandard,eitherbypublicationofanidenticaltextor byendorsement,atthelatestbyOctober2002,andconflictingnationalstandardsshallbewithdrawnatthelatest byOctober2002. ThisdocumentsupersedesENV11861:1994. Thisdocumentisoneofaseriesofmethodsoftestforplasticsmaterialsandarticlesincontactwithfoodstu
18、ffs. ThisdocumenthasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandtheEuropean FreeTradeAssociation,andsupportsessentialrequirementsofECDirective(s). ForrelationshipwithECDirective(s),seeinformativeannexZAwhichisanintegralpartofthisdocument. Atthetimeofpreparationandpublicationofthisst
19、andardtheEuropeanUnionlegislationrelatingtoplastics materialsandarticlesintendedtocomeintocontactwithfoodstuffsisincomplete.FurtherDirectivesand amendmentstoexistingDirectivesareexpectedwhichcouldchangethelegislativerequirementswhichthis standardsupports.Itisthereforestronglyrecommendedthatusersofth
20、isstandardrefertothelatestrelevant publishedDirective(s)beforecommencementofanyofthetestortestsdescribedinthisstandard. ThetitlesofotherpartsofthisEuropeanStandardareasfollows: EN1186MaterialsandarticlesincontactwithfoodstuffsPlastics : Part2 Testmethodsforoverallmigrationintooliveoilbytotalimmersio
21、n Part3 Testmethodsforoverallmigrationintoaqueousfoodsimulantsbytotalimmersion Part4 Testmethodsforoverallmigrationintooliveoilbycell Part5 Testmethodsforoverallmigrationintoaqueousfoodsimulantsbycell Part6 Testmethodsforoverallmigrationintooliveoilusingapouch Part7 Testmethodsforoverallmigrationint
22、oaqueousfoodsimulantsusingapouch Part8 Testmethodsforoverallmigrationintooliveoilbyarticlefilling Part9 Testmethodsforoverallmigrationintoaqueousfoodsimulantsbyarticlefilling Part10 Testmethodsforoverallmigrationintooliveoil(modifiedmethodforuseincaseswhere incompleteextractionofoliveoiloccurs) Part
23、11 Testmethodsforoverallmigrationintomixturesof 14 Clabelledsynthetictriglycerides Part12 Testmethodsforoverallmigrationatlowtemperatures Part13 Testmethodsforoverallmigrationathightemperatures Part14 Testmethodforsubstitutetestsforoverallmigrationintoisooctaneand95%aqueous ethanolEN11861:2002(E) 4
24、Part15 Alternativetestmethodstomigrationintofattyfoodsimulantsbyrapidextractionintoiso octaneand/or95%ethanol AnnexesAandBformnormativepartsofthisstandard.AnnexCisforinformationonly AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowing countriesareboundtoimplem
25、entthisEuropeanStandard:Austria,Belgium,CzechRepublic,Denmark,Finland, France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain, Sweden,SwitzerlandandtheUnitedKingdom.EN11861:2002(E) 5 Introduction Nosingletestmethodhasbeendevisedwhichcanbeusedtodetermineoverall
26、migration,atalltemperatures,in allfoodsimulants.Indeed,owingtothepracticaldifficultiesinherentintestingwithinvolatileextractantssuchas fatsandthemultitudeofapplicationsinwhichplasticsarticlescomeintocontactwithfood,therearemanymethods andpermittedvariationstomethodsinthisstandard. EN11861isintendedt
27、ogiveadviceontheselectionofthemostappropriatetypeoftest,testconditionsandtest methodforagivenapplicationofaplasticsarticleandisintendedtobereadinitsentiretybeforetestingprotocols arefinalized.FormostplasticsarticlesmethodsinEN11862toEN11869aresuitable,accordingtotheformin whichthearticleistested.Sub
28、sequentPartsofthisstandardareintendedtobeusedinconjunctionwiththe methodsinEN11862toEN11869formoredifficultsamplesandatothertemperatures. Thegeneralcriteriafortheoperationandassessmentoftestinglaboratoriesaswellasthegeneralcriteriafor laboratoryaccreditationbodiesaresetoutinEN45001,EN45002andEN45003
29、.Itisrecommendedthat laboratoriesusingthisstandardvalidatetheirproceduresbytestingcertifiedreferencesamplesandbytakingpart inaproficiencyscheme.Referenceplasticssampleswithwellcharacterizedvaluesforoverallmigrationintothe fattyfoodsimulantoliveoilhavebeenpreparedaspartofaprogrammesponsoredbytheStand
30、ards, Measurement b)themigrationinthealternativetestdoesnotexceedtheoverallmigrationlimit,afterapplicationof appropriatereductionfactors. Ifeitherorbothconditionsarenotfulfilled,thenthemigrationtests(4.1)havetobeperformed. 4.3.2Extraction tests Othertestsarepermittedwhichuseothertestmediahavingverystrongextractivepowerunderseveretest conditions,ifitisgenerallyrecognized,onthebasisofscientificevidence,thattheresultsobtainedusingthese extractiontestsareequaltoorhigherthanthoseobtainedwithsimulantD.
