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C,h* ForOfficialUse e  f '"C C'ENV/JM(98)9 g (#C3 (*`hi dd ZZ@ZZ@cdWR%WR%`,IZZ@, ZZ@+  ," # C,*h '$C C' (%C3 ( j  k [mRB>z 8( `)D@ H@E)D)DRUD WXWXWR%WR% WXWXWXWX WXWXWXWX WXWXWXWX WXWXWXWX WR%WR%WXWX*`no ddIZZ@ ZZ@hiWR%WR%`,IZZ@,rZZ@,ZZ@+  ," |* C, 44)) *p  OrganisationdeCooprationetdeDveloppement |+ Economiques q 1'~ 0,C44 C1p*p *p* OLIS: r  s '|-C3 C'30Sep1998 t  u :0|.C C: 44)) *p  OrganisationforEconomicCooperationandDevelopment v 1'2 /C44 C1p*p *p* Dist.: w  x '2 0C3 C'01Oct1998 y (2 1C  ( z *q{| ddIZZ@rZZ@ZZ@noWR%WR%q,\ZZ@+  ,"  1 C, 44))__________________________________________________________________________________________2(& t 3C 44 2*O}~ dd\ZZ@{|WR%WR%O,2ZZ@,*ZZ@+  ,"  < 3 C, 44))  1' < 4C44 C1 Or.Eng.  ( < 5C3 (  *` dd2ZZ@*ZZ@}~WR%WR%`,\ZZ@+  ," R  5 C, 44)) *p  ENVIRONMENTDIRECTORATE   R  6   p*p *p*JOINTMEETINGOFTHECHEMICALSCOMMITTEEANDTHEWORKINGPARTY  7  ^^44ONCHEMICALS   *p   7-+H 9C  ^^ 7  p*p *p*    Ԁ      *O dd\ZZ@WR%WR%O,\ZZ@+  ," H= >C,X?X*   ?5H>C > C?HARMONIZATIONOFCLASSIFICATIONANDLABELLINGSYSTEMSFORCHEMICALSAPPROVALOFHARMONIZEDCRITERIAFOREXISTINGCLASSIFICATIONSYSTEMSENDPOINTS    ԍ̎      @66 DC   C@&G&XX?28thJointMeeting,4th6thNovember1998,tobeheldattheCh teaudelaMuette,Paris, 0!E beginningat9H30on4thNovember  -#! "FC   -  *&&G   $o"G    20Y ST    *O dd\ZZ@XXO,IZZ@, ZZ@+  ," Z C, 69848  'ZC C'  ?5ZC3  C?Ѐ  Ԁ  '"XC C'&G&*  ?5"XC3  C?ww&&GDocumentcompletdisponiblesurOLISdanssonformatd'origine ' C C'&G&ww  ?5 C  C?ww&&G CompletedocumentavailableonOLISinitsoriginalformat ' C C'&G&ww-#! C   - z       N(R@XX(XT  *&&G CommitteeofExpertsontheTransport N ЀofDangerousGoods(716December1998,Agendaitem3(a)(ii))  ACTIVITIESRELATEDTOTHEIMPLEMENTATIONOFAGENDA2GLOBALHARMONIZATIONOFSYSTEMSOFCLASSIFICATIONANDLABELLINGOFCHEMICAL  ~a)) $  7 R m*E`{ 8!S"n#XX~    UKUK.,    &&  Healthhazardsandhazardstotheenvironment  G  TransmittedbytheOrganizationforEconomic r$ CooperationandDevelopment(OECD)CUK.,UK.,    0XX))0    M   ST      ThisdocumentdescribestheworkandcurrentachievementsoftheOECDProgrammeonHarmonization O ofClassificationandLabelling.Itincludesthedetailsoftheproposalsforharmonizedclassificationsystemsforeightofthetenendpointsforwhichthereareexistingclassificationsystems.     ItwassubmittedtotheOECDJointMeetingoftheChemicalsCommitteeandtheWorkingPartyonChemicalsatits28thsession,46November1998,asdocumentENV/JM(98)9. 9   TherepresentativeofOECDwillreportontheoutcomeoftheconsiderationofthedocumentduringthesession.cF $?Zu2Mh !XXc   TheJointMeetingwasinvitedto: I# fFV$?Zu2Mh ! f0  08""0S8"8"0k S"S"0k "k " k  "" xU  $?Zu2Mh !V$x0  08""0S8"8"0S"S"0` ""  i) ` TakenoteofanddiscusstheHarmonizedIntegratedHazardClassificationSystem, G % includingdetailsoftheclassificationsystemsforeightendpoints; ` "` " 0  08""0S8"8"0S"S"0` ""  ii) ` ApprovethederestrictionoffiveDetailedReviewDocumentsonexistingclassification !' systemsinOECDMembercountriesforthefollowingendpoints:GermCellMutagenicity,Reproductivetoxicity,SkinIrritation/Corrosion,EyeIrritation/CorrosionandSensitisation(seeparagraph4); ` "` " 0  08""0S8"8"0S"S"0` ""  iii) ` EndorsethecontentofthegeneralchaptersoftheIntegratedHarmonizedHazard W% #+ ClassificationSystemsDocument,andtheproposalsforclassificationsystemsfortheeightendpointsincludedintheIntegratedDocument,amendedasappropriate(seeAnnex1); ` "` " uR  $?Zu2Mh ! u0  08""0S8"8"0` S"S"  iv) 0 Approvetheproposalforthedescriptivetext,tobemergedwiththecriteriaand (i&/ otheressentialelementsoftheClassificationSystemforAcuteToxicity,amendedasappropriate(seeAnnex2);and ` "` " lL $?Zu2Mh ! l0  08""0S8"8"0S"S"0` ""  v) ` ApprovethesubmissionoftheHarmonizedIntegratedHazardClassificationSystem ?+(2 fortheeightendpoints(withthecaveats,necessarytoensureitsfulland 1  ,)3 appropriateuseintheGloballyHarmonizedClassificationSystemGHS)totheIOMCCoordinatingGroupontheHarmonizationofChemicalClassificationSystems. .Q,6` "` " ~Ug  $?Zu2Mh !  $~  w/)-7  BACKGROUND N  1.  TheAdvisoryGrouponHarmonizationofClassificationandLabelling(AGHCL)wasformallyestablished  inNovember1994andmetforthefirsttimeinFebruary1995.TheobjectiveoftheAGHCLwastoreachconsensusonharmonizedclassificationsystemsforhumanhealthandenvironmentendpointsforwhichthereareexistingsystemsandtocoordinatethework.TheGroupadoptedthefollowingendpointsinitsWorkplanandscheduleofActivities:0  Endpoints,coveredbyexistingclassificationsystems: "" 0   "" C $#"C--C $$C--0  08""  hazardoustotheaquaticenvironment; p 8"8" 0  08""  healthhazardsbasedonacutetoxicity; H 8"8" 0  08""  healthhazardsbasedonskinirritation/corrosion;n 8"8" 0  08""  healthhazardsbasedoneyeirritation/corrosion;F 8"8" 0  08""  healthhazardsbasedonsensitisation; 8"8" 0  08""  healthhazardsbasedongermcellmutagenicity; 8"8" 0  08""  healthhazardsbasedoncarcinogenicity; 8"8" 0  08""  healthhazardsbasedonreproductivetoxicity;X8"8" 0  08""  healthhazardsbasedontargetorganorientedtoxicity;~08"8" 0  08""  healthandenvironmentalhazardsofchemicalmixturesV8"8" 0  Endpointsnotyetcovered: "" 0   "" 0  08""  hazardoustotheterrestrialenvironment;h8"8" 0  08""  healthhazardsbasedonneurotoxicity;and@8"8" 0  08""  healthhazardsbasedonimmunotoxicity.f8"8" 2.  AtthestartoftheProgramme,activitiesonacutetoxicityandaquatichazardswerealreadywellunderway  anditwasdecidedthatDetailedReviewDocuments,bringingtogetherandanalysingallexistingclassificationsystemsforagivenendpoint,werenotnecessaryforthesetwoendpoints.Forallotherendpointsforwhichthereareexistingclassificationssystems,theseStep1DetailedReviewDocumentswereconsiderednecessaryasthebasisforaharmonizedclassificationsystemandasanimportanttooltofacilitatethediscussions.Theworkonendpointsnotyetcoveredbyexistingsystemswasdelayeduntilworkontheotherendpointswouldhavebeenfinished.3.  AfterapprovaloftheStep1DRD,(apartfromacutetoxicityandaquatichazards),forthevarious " endpoints,Step2proposalsweredraftedanddiscussedatexpertmeetingsbeforebeingbroughttotheAGHCL.Forallendpoints,morethanonedraftproposalforaharmonizedclassificationsystemwasdraftedandsubstantialdiscussionswerenecessarytocomeevenclosetoconsensus. ACHIEVEMENTS 6# '  4.  ThefollowingStep1DRDshavebeenapprovedbytheAGHCLandhavebeenmadeavailablethrough $") OLISandaddedtothepasswordprotectedOECDwebpagesontheProgrammeonHarmonisationofClassificationandLabelling(http://www.oecd.org/ehs/classify,username:ClassifyAccount,password:CAccount).Aftertheir &H$+ derestrictionbytheJointMeeting,thesedocumentswillbemadeavailableonthepublicOECDwebpages: n' %, 0  08""  ENV/MC/CHEM(98)21:DetailedReviewDocumentonClassificationSystemsforGermCellMutagenicityinOECDMembercountries(OECDEnvironmentalHealthandSafetyPublications,SeriesonTestingandAssessment,No.12) 8"8" 0  08""  ENV/MC/CHEM(98)22:DetailedReviewDocumentonClassificationSystemsforSensitisingSubstancesinOECDMembercountries(OECDEnvironmentalHealthandSafetyPublications,SeriesonTestingandAssessment,No.13) 8"8" 0  08""  ENV/MC/CHEM(98)28:DetailedReviewDocumentonClassificationSystemsforEyeIrritation/CorrosioninOECDMembercountries(OECDEnvironmentalHealthandSafetyPublications,SeriesonTestingandAssessment,No.14) 8"8" 0  08""  ENV/MC/CHEM(98)29:DetailedReviewDocumentonClassificationSystemsforReproductiveToxicityinOECDMembercountries(OECDEnvironmentalHealthandSafetyPublications,SeriesonTestingandAssessment,No.15)f2098"8" 0  08""  ENV/MC/CHEM(98)30:DetailedReviewDocumentonClassificationSystemsforSkinIrritation/CorrosioninOECDMembercountries(OECDEnvironmentalHealthandSafetyPublications,SeriesonTestingandAssessment,No.16). 8"8" 5.  The5thMeetingoftheAGHCLreachedconsensusonharmonizedclassificationsystemsforsensitisation, ` carcinogenicityandgermcellmutagenicity,whereasconsensuswasreachedonharmonizedclassificationsystemsforskinandeyeirritationduringthe6thMeetingoftheAGHCL.Afterlengthydiscussions,the7thMeetingoftheAGHCLreachedfullagreementonharmonizedclassificationsystemsforreproductivetoxicityandforhazardstotheaquaticenvironment.Finally,themostdisputedareaofacutetoxicitycametoaclosureduringthe8thMeetingoftheAGHCLasthismeetingreachedfullconsensusonallessentialelementsoftheharmonisedclassificationsystemforthisendpoint. THEINTEGRATEDHAZARDCLASSIFICATIONSYSTEM  F  6.  Eventually,theharmonizedclassificationsystemsforthevariousendpointsneedtobeputtogetherand   accompaniedwithgeneralintroductorychaptersexplaininggeneralconsiderations,applicableforalindividualendpoints(e.g.,dataquality,animalwelfare,humandata,weightofevidence)aswellastheorganisationalcontext:howtheworkofOECDinthisrespectwillbeintegratedwiththeIOMCworkbyotherFocalPoints(ILO,UN/CETDG)onotherendpoints(Physicalchemicalproperties)andotheressentialelementsoftheoverallGloballyHarmonizedClassificationSystem(GHS),suchashazardcommunication.7.  The8th,HighLevel,AdvisoryGroupMeetingdiscussedandreachedagreementontheconceptofthe   HarmonizedIntegratedClassificationSystemandonthecontentoftheintroductorychapters.Eventually,harmonizedclassificationsystemsforallendpointsforwhichOECDistheFocalPointwillbeinsertedinthisdocument.Thisdocument,togetherwiththeagreedtextsoftheharmonizedclassificationsystemsforeightoutoftenendpointsforwhichthereareexistingsystems,isattachedtothisdocumentas Annex1 .Asthe8th,HighLevel, > AdvisoryGroupMeetingonlydiscussedandagreedthecriteriaandotheressentialelementsoftheacutetoxicityendpoint,additionaltextwasneededtoprovidethenecessaryguidancetoenableappropriateapplicationofthecriteriaforthissystem.TheUShasdraftedthistextinconsultationwithsomemembersoftheAcuteToxicityWorkingGroup.Inadditiontotheelementsoftheacutetoxicitysystem,agreedbytheAGHCLasincludedintheIntegratedDocument(Annex1),theUSproposalforthefulltextforthisendpointisattachedtothisdocumentas Annex2 . z, 8.  TheJointMeetingisinvitedtocarefullyreviewtheIntegratedDocument,includingtheproposalsfor .! harmonizedclassificationsystemsforeachofthe8endpoints,agreedbytheAGHCL.Afterapprovalofthedocument,amendedasappropriate,theJointMeetingshouldconsideritssubmissiontotheIOMCCoordinatingGrouponHarmonizedChemicalClassificationSystems(CG/HCCS)forinsertioninandsubsequentimplementationoftheGHS.AsOECDMembercountrieshadapprovedtheIntegratedDocumentasawhole,theJointMeetingmaywishtoindicateinitssubmissionthattheIOMCCG/HCCSshouldnotmakeanychangestotheDocumentotherthanthoseofaneditorialnatureandessentialwhenintegratingthedocumentwiththecontributionsfromoftheFocalPoints.  $!(   ANNEX1 N   o_[~ X  0 !@Kd d@EXhX  oR  $?Zu2Mh !g oINTRODUCTION   & &&&&   a)) $  7 R m*E`{ 8!S"n#     UKUK.,  &CD)&&&&Theproductionanduseofchemicalsisfundamentalintheeconomicdevelopmentofallcountriesand,atthesame  F time,itmayposearisktothehealthandwellbeingofallpeopleandtheenvironmentifnotmanagedinaresponsiblemanner. Theprimaryobjectiveofhazardclassificationandcommunicationsystemsistoprovideinformationto D  protecthumanhealthandtheenvironment.Oneessentialstepleadingtothesafeuseofchemicalsistheidentificationofthespecifichazardsandtheorganisationofthatinformationsothatitcanbeconveyedtousersofchemicalsinaformthatiseasytounderstand.Measurescanthenbetakentoavoidormanagepotentialrisksincircumstanceswhereexposuremayoccur.Thisisthefundamentalrationalebehindthehazardclassificationandlabellingofchemicals.Ithastraditionallyledatthenationalleveltosectorspecificregulations(transport,industry,environment,health,agriculture,consumerproducts,occupationalhealth).Becauseofdifferencesinuseandexposure,hazardclassificationsystemsusuallyvarybetweensectors.Insomecases,thereislittleornoconsistencywithinsectorsbetweendifferentcountries.CD  In1952,theInternationalLaborOffice(ILO)beganastudyoftheclassificationandlabellingofdangeroussubstanceswhichledin1989toaResolutionconsideringtheharmonizationofsystemsofclassificationandlabellingfortheuseofhazardouschemicalsatwork.In1953,theUNEconomicandSocialCouncilcreatedtheUNCommitteeofExpertsontheTransportofDangerousGoods(UNCETDG)chargedwithdevelopingrecommendationsaddressedtogovernmentsandinternationalorganizationsconcernedwiththeregulationofthetransportationofdangerousgoods;amongstotheraspects,theseRecommendationscovertheprinciplesofclassificationanddefinitionsoftheclassesofdangerousgoods.In1956,theUNCETDGfirstpublisheditsUNRecommendationsonTransportofDangerousGoods(UNRTDG)whichwererecentlymodified(1997)forthetenthtime.TheUNRTDGarenowincludedinthetransportlegislationofmanyUNstatesandtheyareusedbytheInternationalMaritimeOrganisation(IMO),theInternationalCivilAviationOrganisation(ICAO)andotherinternationalbodiescoveringtransportmodes.Thuslandseaairtransportistheonlysectorwhereharmonizationofhazardclassificationandlabellinghasbeentoalargedegreeachieved. 1UUK.,UK.,    3 ))3  {[1Lg  $?Zu2Mh ! {TheUNConferenceonEnvironmentandDevelopment(UNCED)in1992identifiedtheharmonizationofclassificationandlabellingofchemicalsasoneofsixactionprogramsinChapterXIXofUNCEDAgenda21.Itsobjectivewas: agloballyharmonizedhazardclassificationandcompatiblelabellingsystem(GHS)includingmaterialsafetydatasheetsandeasilyunderstandablesymbols,shouldbeavailable,iffeasible,bytheyear2000.Itwasrecognizedthat,whileaharmonizedclassificationsystemmightbefeasible,harmonized labelling mayormaynotbe "g $ appropriateorpossibleacrossallsectors, butthatcompatabilityoflabellingsystemsmightbeachievable.   #C!% & &&&&   a)) $  7 R m*E`{ 8!S"n#1    UKUK.,  & &&&&UNCEDidentifiedtheInternationalProgramonChemicalSafety(IPCS)asthenucleusforinternationalcooperation 9%"' onChapterXIXactivities.UndertheumbrellaofIPCSaCoordinatingGroupfortheHarmonizationofChemicalClassificationSystems(CG/HCCS)wasestablishedtopromoteandoverseetheworktodevelopaGHS.Later,theoversightoftheworkoftheCG/HCCSwasprovidedbythebroaderInterOrganisationalProgrammefortheSoundManagementofChemicalsIOMC.AsexpressedintheCG/HCCSTermsofReference,thegoalsofinternationalharmonizationareto:   dUK.,UK.,    31))3  ,  a)) $  7 R m*E`{ 8!S"n#1    UKUK.,  0  08""  enhancetheprotectionofmankindandtheenvironmentbyprovidinganinternationallycomprehensiblesystemforhazardcommunication; 8"8" 0  08""  providearecognizedframeworkforthosecountrieswithoutanexistingsystem; 8"8" 0  08""  reducetheneedfortestingandevaluationofchemicals; 8"8" 0  08""  facilitateinternationaltradeinchemicalswhosehazardshavebeenproperlyassessedandidentifiedonaninternationalbasis.1O/68"8" ,hUK.,UK.,    31))3  C $$C ORGANIZATIONALCONTEXTFORDEVELOPMENTOFTHEGHS   N     a)) $  7 R m*E`{ 8!S"n#1    UKUK.,  ThefirstpriorityoftheCG/HCCSwasthedevelopmentofaharmonizedclassificationsystemdefiningthehazardsofvariousendpointsofconcern.TheOrganisationforEconomicCooperationandDevelopment(OECD)wasidentifiedastheFocalPointforworkonhumanhealthandenvironmentalhazards,ILO/UNCETDGastheFocalPointforworkonphysicalhazards,andILOastheFocalPointforworkonHazardCommunication.TheCG/HCCSwouldintegratetheharmonizedclassificationschemewithaharmonizedhazardcommunicationsystemtogiveanoverallGloballyHarmonizedClassificationandlabellingSystem(GHS).   smUK.,UK.,    31))3  ]= $1 9AI!1] TheOECDAdvisoryGrouponHarmonizationofClassificationandLabelling(AGHCL)       & &&&&   a)) $  7 R m*E`{ 8!S"n# 1 X    UKUK.,  rU}g  $?Zu2Mh !))r& &&&&TheAG-HCLwasformallyestablishedin1994bytheJointMeetingoftheOECDChemicalsGroupand y +  ManagementCommitteetodevelopproposalsforaharmonizedclassificationsystemforthehazardsofchemicalstohumanhealthandtheenvironment.ItbaseditsworkontheinitialeffortsofanOECDClearingHouse(19911993)ontheAcuteHumanToxicityandontheAcuteAquaticToxicityofchemicals.  InitsworktheAG-HCLfollowedasetofgeneralprinciplesdevelopedbytheIOMC-GG/HCCSfortheworkonharmonizationofthehazardclassificationofchemicals,thatspecifically:. rUK.,UK.,    ? 1 X}g ?  C $$C--C $$C--~Ug  $?Zu2Mh ! 1 X~0  08""  thelevelofprotectionofferedtoworkers,consumers,thegeneralpublicandtheenvironmentshouldnotbereducedasaresultofharmonizingtheclassificationandlabellingsystems; 8"8" 0  08""  thehazardclassificationprocessrefersonlytothehazardsarisingfromtheintrinsicpropertiesofchemicalelementsandcompounds,andmixturesthereof,whethernaturalorsynthetic; 8"8" 0  08""  harmonizationmeansestablishingacommonandcoherentbasisforchemicalhazardclassificationandcommunication,fromwhichtheappropriateelementsrelevanttomeansoftransport,consumer,workerandenvironmentprotectioncanbeselected; 8"8" 0  08""  thescopeofharmonizationincludesbothhazardclassificationcriteriaandhazardcommunicationtools,e.g.labellingandchemicalsafetydatasheets; 8"8" 0  08""  changesinallexistingsystemswillberequiredtoachieveasinglegloballyharmonizedsystem;transitionalmeasuresshouldbeincludedintheprocessofmovingtothenewsystem. 8"8" 0  08""  theinvolvementofconcernedinternationalorganisationsofemployers,workers,consumers,andotherrelevantorganisationsintheprocessofharmonizationshouldbeensured, 8"8" 0  08""  thecomprehensionofchemicalhazardinformation,bythetargetaudience,e.g.workers,consumersandthegeneralpublic,shouldbeaddressed; 8"8" 0  08""  testdataalreadygeneratedfortheclassificationofchemicalsundertheexistingsystems,shouldbeacceptedwhenreclassifyingthesechemicalsundertheharmonizedsystem; 8"8" 0  08""  anewharmonizedclassificationsystemmayrequireadaptationofexistingmethodsfortestingofchemicals; 8"8" 0  08""  inrelationtochemicalhazardcommunication,thesafetyandhealthofworkers,consumersandthepublicingeneralshouldbeensuredwhileprotectingconfidential Y businessinformation,asprescribedby )&/ thecompetentauthorities.   8"8" C $$CZ= $1 9AI!g Z   a)) $  7 R m*E`{ 8!S"n# 1 X    UKUK.,  TheworkoftheAGHCLwasgenerallyofthreerelatedkinds:a   KlabUK.,UK.,    < 1 X))<  C $$C--~U}g  $?Zu2Mh ! 1 X~0  08""  X Comparisonofthemajorclassificationsystems,identificationofsimilaroridenticalelementsand,fortheelementswhichweredissimilar,developmentofaconsensusonacompromise;a   8"8" 0  08"" 8"8" 0  08""  X Examinationofthescientificbasisforthecriteriawhichdefinetheend-pointofconcern,gainingexpertconsensusonthetestmethods,datainterpretationandlevelofconcern,andthenseekingconsensusonthecriteria.Forsomeendpoints,theexistingschemeshadnocriteriaandtherelevantcriteriaweredevelopedbytheAG-HCL; 8"8" 0  08""&andlabel&&&&-30;8"8" 0  08""  X &andlabel&&&&Wheretherewasadecisiontreeapproach(e.g.irritation)orwherethereweredependentcriteriaintheclassification N scheme(acuteaquatictoxicity),developmentofconsensusontheprocessortheschemeforusingthecriteria. 8"8"    a)) $  7 R m*E`{ 8!S"n#}g     UKUK.,  C $$Ca  TheAG-HCLproceededstepwiseindevelopingitsharmonizedclassificationcriteria.Foreachend-pointthefollowingstepsundertaken: 3labUK.,UK.,    3}g ))3  uU}g  $?Zu2Mh !}g u  Step1:  a    0  X   Athoroughanalysisofexistingclassificationsystems,includingthescientificbasisforthesystemanditscriteria,itsrationaleandexplanationofthemodeofuse.AStep1documentispreparedandamendedasrequiredafterdiscussionbyAG-HCL ""   Step2:     0  X   Aproposalforaharmonizedclassificationsystemandcriteriaforeachclassisdeveloped.AStep2documentispreparedandamendedasrequiredafterdiscussionbyAG-HCL "" 0  X    ""   Step3:   4   (a) 8 AG-HCLreachesconsensusontherevisedStep2proposal;or    (b) 8 Afterattemptsatconsensusbuildingfail,thespecificnonconsensusitems F    8 areidentifiedasalternativesinarevisedStep2proposal.   a)) $  7 R m*E`{ 8!S"n#}g     UKUK.,    Step4: S a     labUK.,UK.,    3}g ))3  &  uU}g  $?Zu2Mh !}g u0  X   FinalproposalissubmittedtotheOECDJointMeetingforapprovalandsubsequentlytotheIOMCCG-HCCSforglobalimplementation.a   "" 0  X  ""    a)) $  7 R m*E`{ 8!S"n#}g     UKUK.,  Asexperiencewiththeuseofthesystemisaccumulated,andasnewscientificinformationemerges,thetestmethods,theinterpretationofthetestdataandtheharmonizedcriteriapersemayhavetobeupdated.Thus,internationalwork   willcontinuetobeneededinthefutureand,dependingonthenatureofthefutureinternationalinstrumentfortheimplementationoftheGHS,decisionswillhavetobemadeonthemechanismforcarryingouttheupdatingworkinthefuture.'@a   וlabUK.,UK.,    3}g ))3  uU}g  $?Zu2Mh !}g u GENERALCONSIDERATIONS a   B!% &andlabel&&&&&andlabel&&&& Scope oftheHarmonizedClassificationSystem  " ' &andlabel&&&&   a)) $  7 R m*E`{ 8!S"n#}g     UKUK.,  &andlabel&&&&Theworkonharmonizationofhazardclassificationandlabellingfocusesonaharmonizedsystemforallchemicals $@") andmixturesofchemicals.Theapplicationofthecomponentsofthesystemmayvarybytypeofproductorstageofthelifecycle.a  Theclassification systemappliestopurechemicalsubstances,theirdilutesolutionsand tomixturesofchemical '%- substances.However,sincespecialconsiderationsareneededtoclassifymixtures,anOECDWorkingGrouponClassificationCriteriaforMixtureshasbegunitsworktoaddressharmonizationinthisarea.Oneobjectiveoftheharmonizedhazardclassificationsystemisforittobesimpleandtransparentwithacleardistinctionbetweenclassesinordertoallowfor selfclassificationasfaraspossible.Formanyend-pointsthecriteriaaresemi-quantitativeorqualitativeandexpertjudgementisrequiredtointerpretthedataforclassificationpurposes.Furthermore,forsomeend-points,e.g.eyeirritation,adecisiontreeapproachisgivenasanexample. \accUK.,UK.,    3}g ))3  PresentationofCriteriaXX&&dbeaccepd   W/ -6  uU}g  $?Zu2Mh !}g u&&XXdbeaccepThecurrentcriteriaforspecificendpointsarepresentedasaseriesofchaptersinthispaper.Thesechaptersinclude 1.8 anumberofsectionsallofwhicharerelevanttoclassificationdecisions.SomechaptersalsohaveanAppendixwhich,unlessclearlyindicatedtothecontrary,arenotpartofthecriteriaandshouldberegardedasbackground 2}0: informationonly.Foroneendpoint(hazardousfortheaquaticenvironment)aseparateGuidanceDocumentisconsideredessentialforagoodunderstandinganduseofthesystem. TestMethods andTestDataQuality   &iteriaare&&&&   a)) $  7 R m*E`{ 8!S"n#}g     UKUK.,  &iteriaare&&&&Theclassificationofachemicalsubstancedependsbothonthecriteriaandonthereliabilityofthetestmethods ~0 underpinningthecriteria.Insomecasestheclassificationisdeterminedbyapassorfailofaspecifictest,e.g.thereadybiodegradationtest,whileinothercases,interpretationsaremadefromdose/responsecurvesandobservationsduringtesting.Inallcases,thetestconditionsneedtobestandardizedsothattheresultsarereproduciblewithagivenchemicalsubstanceandthestandardizedtestyields validdatafordefiningtheend-pointofconcern.Inthiscontext,validationistheprocessbywhichthereliabilityandtherelevanceofaprocedureareestablishedforaparticularpurpose.it  Teststhatdeterminehazardouspropertieswhichareconductedaccordingtointernationallyrecognisedscientificprinciplescanbeusedforpurposesofahazarddeterminationforhealthandenvironmentalhazards.TheGHScriteriafordetermininghealthandenvironmentalhazardsshouldbetestmethodneutral,allowingdifferentapproachesaslongastheyarescientificallysoundandvalidatedaccordingtointernationalproceduresandcriteriaalreadyreferredtoinexistingsystemsfortheendpointofconcernandproducemutuallyacceptabledata. iaaUK.,UK.,    3}g ))3  uU}g  $?Zu2Mh !}g u PreviouslyClassifiedChemicals it   , uUg  $?Zu2Mh !}g u   ~a)) $  7 R m*E`{ 8!S"n#g ~    UKUK.,  OneofthegeneralprinciplesestablishedbytheIOMC-CG-HCCSstatesthattestdataalreadygeneratedfortheclassificationofchemicalsundertheexistingsystemsshouldbeacceptedwhenclassifyingthesechemicalsundertheharmonizedsystemtherebyavoidingduplicativetestingandtheunnecessary useoftestanimals.Thispolicyhas > importantimplicationsinthosecaseswherethecriteriaintheGHSaredifferentfromthoseinanexistingsystem.Insomecases,it maybedifficult todeterminethequalityofexistingdatafromolderstudies.Insuchcases, expert @ judgementwillneeded.it   iaaUK.,UK.,    0g ))0  SubstancesPosingSpecialProblems it   m rU}g  $?Zu2Mh !g r   a)) $  7 R m*E`{ 8!S"n#}g     UKUK.,  Theeffectofasubstanceonbiologicalandenvironmentalsystemsisinfluenced,interalia,bythephysicochemicalpropertiesofthesubstanceandthewayinwhichitisbiologicallyavailable.Somegroupsofsubstancespresentspecialproblemsinthisrespect,forexamplesomepolymersandmetals.it   iaaUK.,UK.,    3}g ))3  uU}g  $?Zu2Mh !}g u AnimalWelfare it   l" uUg  $?Zu2Mh !}g u   ~a)) $  7 R m*E`{ 8!S"n#g ~    UKUK.,  Thewelfareofexperimentalanimalsisaconcern.Thisethicalconcernincludesnotonlythealleviationofstressandsufferingbutalso,insomecountries,theuseandconsumptionperseoftestanimals.Wherepossibleandappropriate, B!% testsandexperiments thatdonotrequiretheuseofliveanimalsarepreferredtothoseusingsentientliveexperimental "& animals.Tothatend,forcertainendpoints(skinandeyeirritation/corrosion)testingschemesstartingwithnonanimalobservation/measurementsareincludedaspartoftheclassificationsystem.Forotherendpointssuchasacutetoxicity,alternativeanimaltests,usingfeweranimalsorcausinglesssufferingareinternationallyacceptedandshouldbepreferredtotheconventionalLD50test.it   iaaUK.,UK.,    0g ))0  EvidenceFromHumans it   '$,    ~a)) $  7 R m*E`{ 8!S"n#g ~    UKUK.,  ݀Forclassificationpurposes,reliableepidemiological dataandexperienceontheeffectsofchemicalsonhumans(e.g. (&. occupationaldata,datafromaccidentdatabases)shouldbetakenintoaccountintheevaluationofhumanhealthhazardsofachemical.Testingonhumanssolelyforhazardidentificationpurposesisgenerallynotacceptable.it   iaaUK.,UK.,    0g ))0  WeightofEvidence it    ,)2   ,*3    ~a)) $  7 R m*E`{ 8!S"n#g ~    UKUK.,  &   Forsomehazardendpoints,classificationresultsdirectlywhenthedatasatisfythecriteria.Forothers,classificationofachemicalismadeonthebasisofthetotalweightofevidence.Thismeansthatallavailableinformationbearingonthedeterminationoftoxicityisconsideredtogether,includingtheresultsofvalidinvitrotests,relevantanimaldata,andhumanexperiencesuchasepidemiologicalandclinicalstudiesandwelldocumentedcasereportsandobservations.it  Thequalityandconsistencyofthedataareimportant.Evaluationofsubstancesrelatedtothematerialunderstudy shouldbeincluded,asshouldsiteofactionandmechanismormodeofactionstudyresults.Bothpositiveandnegativeresultsareassembledtogetherinasingleweightofevidencedetermination..'NPositiveeffectswhichareconsistentwiththecriteriaforclassificationineachchapter,whetherseeninhumansoranimals,willnormallyjustifyclassification.Whereevidenceisavailablefrombothsourcesandthereisaconflictbetweenthefindings,thequalityandreliabilityoftheevidencefrombothsourcesmustbeassessedinordertoresolvethequestionforclassification.Generally,dataofgoodqualityandreliabilityinhumanswillhaveprecedenceoverotherdata.However,evenwelldesignedandconductedepidemiologicalstudiesmaylacksufficientnumbersofsubjectstodetectrelativelyrarebutstillsignificanteffects,ortoassesspotentiallyconfoundingfactors.Positiveresultsfromwellconductedanimalstudiesarenotnecessarilynegatedbythelackofpositivehumanexperiencebutrequireanassessmentoftherobustnessandqualityofboththehumanandanimaldatarelativetotheexpectedfrequencyofoccurrenceofeffectsandtheimpactofpotentiallyconfoundingfactors.Routeofexposure,mechanisticinformationandmetabolismstudiesarepertinenttodeterminingtherelevanceofaneffectinhumans.Whensuchinformationraisesdoubtaboutrelevanceinhumans,alowerclassificationmaybewarranted.Whenitisclearthatthemodeormechanismofactionisnotrelevanttohumans,thesubstanceshouldnotbeclassified.Bothpositiveandnegativeresultsareassembledtogetherintheweightofevidencedetermination.However,asinglepositivestudyperformedaccordingtogoodscientificprinciplesandwithstatisticallyandbiologicallysignificantpositiveresultsmayjustifyclassification. iaaUK.,UK.,    0g ))0  BUILDINGBLOCKAPPROACH it   q# Atvarioustimesduringthedevelopmentofharmonizedclassificationcriteria,concernshavearisenconcerningthewayaharmonizedclassificationsystemmightbeusedandwhetheritwouldmeettheneedsofitsvariousend-users.   ~a)) $  7 R m*E`{ 8!S"n#g ~    UKUK.,  ݀OneoftheconsequencesoftheapplicationoftheclassificationsystemisexpressedintheIOMCCG/HCCSGeneralPrinciple(c):la   pificUK.,UK.,    0g ))0  rU}g  $?Zu2Mh !g r0  X   harmonizationmeansestablishingacommonandcoherentbasisforchemicalhazardclassificationandcommunication,fromwhichtheappropriateelementsrelevanttomeansoftransport,consumer,workerandenvironmentprotectioncanbeselected.la   "" 0  X  ""    a)) $  7 R m*E`{ 8!S"n#}g     UKUK.,  ݀Inthefollowingchapters,sufficientsubclasseshavebeenincludedundersomeendpointstoaccommodatethefundamentalneedsoftheexistingsystems.Theapplicationoftheclassificationschememayvaryaccordingtothecircumstances,typeofproduct,astageofthelifecycleofthechemical.la  ̀Itisessentialthatthecutoffsberecognizedasafundamentalbasisfortheharmonizedclassificationsystem.Theuseofdifferentcutoffsforanyuseoftheclassificationsystemwouldbecontrarytoharmonization. lificUK.,UK.,    3}g ))3   (Y&.   HARMONIZEDSYSTEMFORTHECLASSIFICATIONOFCHEMICALSWHICHCAUSEACUTE N TOXICITY la   & `@?Zu2Mh !}g `   HARMONIZEDCLASSIFICATIONSCHEMEFORACUTETOXICITY  `   *q ddd Xdd Xdd XX"X"q,jZ@,7jZ@,7jZ@,7jZ@,7jZ@,7jj@+  1" ^ C19g ?9 9*n C C9Class1 9*  C C9Class2 9*n  C C9Class3 9*n  C C9Class4 =*n  C C=Class5 L=%n C   CLOral(mg/kg) 9* C C95 9* C C950 9* C C9300 9* C C92000 =* C C=5000Seedetailedcriteria L=% h C   CLDermal(mg/kg) 9* P C C950 9* P C C9200 9* P C C91000 9* P C C92000 =* P C C= L=%v ( C   CLGases(ppm)Notea 9*"C C9100 9*^ #C C9500 9*^ $C C92500 9*^ %C C95000 =*^ &C C= L=%^ 'C   CLVapours(mg/L)NoteaNotebNotec 9*-C C90.5 9*X/C C92.0 9*0C C910 9*1C C920 =*2C C= N=%3C   CNDustsandMists(mg/L)NotedNotea ;*N8C C;0.05 ;*9C C;0.5 ;*:C C;1.0 ;*;C C;5 =*<C C=5+)=C    5  rUg  $?Zu2Mh !g rNotestothescheme:  a.Conversionofexistinginhalationtoxicitydatawhichhavebeengeneratedaccordingtoexposures̀otherthan4hoursshouldbeaccordingtothefollowingformulae:̀Fordustsandmists:LC50(4hours)isequivalenttoLC50(xhours)"(x/4). n B ЀForvapours:LC50(4hours)isequivalenttoLC50(1hour)"(1/2). F C   uXg  $?Zu2Mh !g u0 0 X b. 0 Itisrecognisedthatsaturatedvapourconcentrationmaybeusedasanadditionalelementbysomeregulatory !E systemstoprovideforspecifichealthandsafetyprotection(e.g.UNRecommendationsfortheTransportofDangerousGoods). 0"0" 0 0 X  0"0" 0 0 X c. 0 Itisrecognisedthatforsomechemicalsthetestatmospherewouldnotjustbeavapourbutwouldconsistof V%#I amixtureofliquidandvapourphases,andforsomechemicalsthetestatmospheremayconsistofavapourwhichisnearthegaseousphase.Intheselattercases,classificationwouldbebasedonppmasfollows:Class1(100ppm),Class2(500ppm),Class3(2500ppm),Class4(5000ppm).WorkintheOECDTestProgrammeshouldbeundertakentobetterdefinetheterms dusts, mistsand vapoursinrelationtotheinhalationtoxicitytesting. 0"0" 0 0 X  0"0" 0 0 X d. 0 ThevaluesfordustsandmistsshouldbereviewedtoadapttoanyfuturechangestoOECDTestGuidelines >+(P withrespecttotechnicallimitationingenerating,maintainingandmeasuringdustandmistconcentrationsinrespirableform. 0"0" 0 0 X  0"0" uUg  $?Zu2Mh !g u CriteriaforClass5 .P,T  ThecriteriaforClass5areintendedtoenabletheidentificationofsubstanceswhichareofrelativelylowacutetoxicityhazardbutwhich,undercertaincircumstances,maypresentadangertovulnerablepopulations.ThesesubstancesareanticipatedtohaveanoralordermalLD50intherangeof20005000mg/kgorequivalentdosesforotherroutes. uXg  $?Zu2Mh !g u0 0 X 20Y0"0" 0 0 X 1. 0 ThesubstanceisclassifiedinClass5ifreliableevidenceisalreadyavailablethatindicatestheLD50or(LC50) N tobeintherangeofClass5values;orotheranimalstudiesortoxiceffectsinhumansindicateaconcernforhumanhealthoranacutenature. 0"0" 0 0 X  0"0" 0 0 X 2. 0 ThesubstanceisclassifiedinClass5,throughextrapolation,estimationormeasurementofdata,ifassignment ` toamorehazardousclassisnotwarranted,and 0"0" 0 0 X  0"0" C $$C--C $$C--uUg  $?Zu2Mh !g u0  08""  X reliableinformationisavailableindicatingsignificanttoxiceffectsinhumans;or 68"8" 0  08""  X anymortalityisobservedwhentesteduptoclass4valuesbytheoral,inhalation;ordermalroutes;or 8"8" 0  08""  X whereexpertjudgementconfirmssignificantclinicalsignsoftoxicity,whentesteduptoClass4values,exceptfordiarrhoea,piloerectionoranungroomedappearance, or t 8"8" 0  08""  X whereexpertjudgementconfirmsreliableinformationindicatingthepotentialforsignificantacuteeffectsfromtheotheranimalstudies. 8"8" uXg  $?Zu2Mh !g u0 0  0"0"   rR  $?Zu2Mh !g rRecognisingtheneedtoprotectanimalwelfare,testinginanimalsinClass5rangesisdiscouragedandshouldonly beconsideredwhenthereisastronglikelihoodthatresultsofsuchatestwouldhaveadirectrelevancefor   protectinghumanhealth.      uUg  $?Zu2Mh ! u HARMONIZEDSYSTEMFORTHECLASSIFICATIONOFCHEMICALSWHICHCAUSESKIN N IRRITATION/CORROSION  &  EXECUTIVESUMMARY  `    ~a)) $  7 R m*E`{ 8!S"n#g ~    UKUK.,  Fromacomparisonofexistingdermalirritation/corrosionclassificationprocedurescurrentlyinuse,aharmonizedsystemwasformulated.Itincludesanevaluationstrategyofexistinginformationandspecifictestingfordermaleffects.Indevelopingpotentialharmonizedpositionsfordermalirritation/corrosiontesting,twoobjectiveshavebeenkeptinmind:todefinecriteriaforbothcorrosionandirritationclassificationthatareintherangeofsensitivityofexistingsystemsandtohavethepossibilityofsubdividingeffectsintodifferentsubclassesforthoseauthoritiesthatneedthem.la  Asingleclassisadoptedforskincorrosion.Authoritieswantingtohaveuptothreesubclassesmaysubdividethesinglecorrosiveclass.ThesesubclassesaremodeledafterthosecurrentlyinuseintheUnitedNationstransportauthority.Asingleclassisadoptedforskinirritation.TheclassificationproceduredrawsuponthosecurrentlyemployedbytheEuropeanUnion(EU).Erythema/escharandedemaaregradedseparately;ananimalsmeanscorefromreadingsoverthefirstthreedaysafterexposuremustmeeta definedleveltobepositive;andatleast2of3testedani