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GuidetotheimplementationofdirectivesbasedontheNewApproachandtheGlobalApproach★★★★★★★★★★★★EuropeanCommissionGuidetotheimplementationofdirectivesbasedontheNewApproachandtheGlobalApproachEuropeanCommissionThisdocumentisavailableontheInternetandcanbedownloadedinall11officialEUlanguagesfromtheEuropaserveratthefollowingaddress:().Cataloguingdatacanbefoundattheendofthispublication.Luxembourg:OfficeforOfficialPublicationsoftheEuropeanCommunities,2000ISBN92-828-7500-8©EuropeanCommunities,2000Reproductionisauthorisedprovidedthesourceisacknowledged.PrintedinItalyGuidetotheimplementationofdirectivesbasedontheNewApproachandtheGlobalApproachFOREWORDThesinglemarketisoneofthegreatachievementsofourtime.Thiseconomicspace,wheregoods,services,capitalandlabourcancirculatefreely,providesafoundationforprosperityintheEuropeanUnionaswemovetowardsthe21stcentury.TheEuropeanUnionhasdevelopedoriginalandinnovativeinstrumentstoremovethebarrierstofreecirculationofgoods.Amongthese,theNewApproachtoproductregulationandtheGlobalApproachtoconformityassessmenttakeprideofplace.Thecommonthreadbetweenthesecomplementaryapproachesisthattheylimitpublicinterventiontowhatisessentialandleavebusinessandindustrythegreatestpossiblechoiceonhowtomeettheirpublicobligations.Since1987some20directives,adoptedonthebasisoftheNewApproachandtheGlobalApproach,haveprogressivelycomeintoforce.Theoperationofanyinnovativesysteminevitablyraisesquestions.AfirstGuide,intendedtoanswersomeofthese,waspublishedin1994.Thishasnowbeenupdatedandrewritten,onthebasisofexperience.WehopethatthisGuidewillbehelpfultothosewhowanttodobusinessinthesinglemarketandthatitwillassistthosewhosejobitistomanagethemarketplace.ItwillbeaninvaluableaidtothecandidatecountriesofcentralandeasternEuropeintakingovertheNewApproachandtheGlobalApproachandthedirectivesadoptedfollowingthem.Wedaretohopethatitwillalsocontributetobetterunderstandingofthesemethodsinothercountriesandmayevenleadthemtoadoptsimilarprinciples.AGuidecan,atbest,onlydrawoutthemeaning,significanceandpracticalconsequencesofthedirectivestowhichitrefers.Itcannotreplacealegaltext,orchangewhatthelegislatorhasdecided.However,itcanelucidatethelegaltextbybringingtobearknowledgeoftheusageoftheEuropeanUnionandtheprovisionsoftheEuropeanCommunityTreatyanditsderivedlaw,includingthecaselawoftheEuropeanCourtofJustice.TheEuropeanCommissionisuniquelywellplacedtodothis.IthasconsultedwidelyinpreparingtheGuideandallopinionshavebeencarefullyconsidered.TheGuidehasbeendiscussedwiththeSeniorOfficialsGrouponStandardisationandConformityAssessmentPolicy,whoagreedtoitspublication.Asfaraspossible,itreflectsabroadconsensus.Whilethisdoesnotmeanthatitisthelastwordonanything,itcertainlymeansthatitrepresentsanauthoritativeexpressionofopinion.ThisGuidehasbeendrawnupbytheDirectorate-GeneralforEnterpriseinclosecooperationwithotherCommissionserv-ices,withcontributionsfromMemberStateexpertsandinterestgroups.Mythankstoallwhohavecontributedtothisenterprise.MagnusLemmelActingDirector-GeneralDirectorate-GeneralforEnterpriseSeptember19993IMPORTANTNOTICEThisGuideisintendedtocontributetobetterunderstandingofdirectivesbasedontheNewApproachandtheGlobalApproach,andtotheirmoreuniformandcoherentapplicationacrossdifferentsectorsandthroughoutthesinglemarket.ItisaddressedtotheMemberStates.ItisalsointendedtobeamanualforotherswhoneedtobeinformedoftheprovisionsdesignedtoensurethefreecirculationofCEmarkedprod-uctsaswellasahighlevelofprotectionthroughouttheCommunity(suchastradeassocia-tions,consumerassociations,standardsbodies,manufacturers,importers,distributors,conformityassessmentbodies,tradeunions).Itreflectsthestateoftheart.Therefore,theguidanceofferedmaybesubjecttomodifica-tionsinthefuture.Onlythetextofthedirectiveisauthenticinlaw.Accordingly,thetextofthedirectiveisappli-cablewheretherearedifferencesbetweentheprovisionsofadirectiveandthecontentsofthisGuide.Inparticular,thesedifferencesareduetoslightlydivergentprovisionsintheindi-vidualdirectives,whichcannotbefullydescribedinthisGuide.ThefocusofthisGuideisontheNewApproachandtheGlobalApproach.However,productscoveredbydirectivesbasedontheprinciplesoftheNewApproachandtheGlobalApproachmayalsobesubjecttootherprovisionsofCommunitylaw,whicharenotpresentedinthisGuide.TheguidanceofferedtotheMemberStatesinthisGuidealsoappliestoIceland,Liechten-steinandNorwayassignatoriesoftheAgreementontheEuropeanEconomicArea(EEA).ReferencestotheCommunityorthesinglemarketare,accordingly,tobeunderstoodasreferringtotheEEA,ortotheEEAmarket.41.Introduction............................71.1.ConceptoftheNewApproachandtheGlobalApproach..71.2.StandardelementsofNewApproachdirectives........81.3.AdoptionofNewApproachdirectives..............101.4.TranspositionofNewApproachdirectives...........111.5.NewApproachdirectives......................122.ScopeofNewApproachdirectives.........152.1.Prod