NoC28/16 OfficialJournaloftheEuropeanCommunities 2.2.93
MODIFICATION OFTHEPROPOSAL FORACOUNCILREGULATION (EEC)
CONCERNING THEAFFIXING ANDUSEOFTHECEMARKOFCONFORMITY ON
INDUSTRIAL PRODUCTSHINAPROPOSALFORACOUNCILDIRECTIVE ANDA
PROPOSAL FORACOUNCILDECISION
ProposalforaCouncilDirectiveamendingCouncilDirectives87/404/EEC(simplepressure
vessels),88/378/EEC(safetyoftoys),89/106/EEC(constructionproducts),89/336/EEC
(electromagnetic compatibility ),89/392/EEC(machinery),89/686/EEC(personalprotective
equipment),90/384/EEC(non-automatic weighinginstruments),90/385/EEC(active
implantablemedicaldevices),90/396/EEC(appliancesburninggaseousfuels),91/263/EEC
(telecommunications terminalequipment),92/42/EEC(newhot-waterboilersfiredwithliquidor
gaseousfuels),and73/23/EEC(electricalequipmentdesignedforusewithincertainvoltage
limits)
(93/C28/02)
andintoa
COM(92)499final—SYN336A
(SubmittedbytheCommissiontotheCouncilon7December1992pursuanttoArticle149(3)of
theEECTreaty)
Whereasthetwobasicelementsofthenewapproach
whichmustbeappliedarethereforetheessential
requirementsandtheconformityassessmentprocedures;
Whereasthisharmonization oftheprovisionsconcerning
theaffixinganduseoftheCEmarkingrequiresthat
existingdirectivesundergodetailedamendmenttobring
themintolinewiththenewarrangements ;
HASADOPTEDTHISDIRECTIVE :THECOUNCILOFTHEEUROPEAN COMMUNITIES ,
HavingregardtotheTreatyestablishingtheEuropean
EconomicCommunity ,andinparticularArticle100a
thereof,
HavingregardtotheproposalfromtheCommissionin
cooperationwiththeEuropeanParliament,
HavingregardtotheopinionoftheEconomicandSocial
Committee ,
WhereastheCouncilhasalreadyadoptedseveraldirectives
designedtoremovetechnicalbarrierstotradeonthebasis
ofArticle100aoftheTreatyandinaccordancewiththe
principlesestablishedinitsResolutionof7May1985
onanewapproachtotechnicalharmonization and
standards(2);whereaseachofthesedirectivesprovidesfor
theaffixingoftheCEmarking;whereas,therefore,inthe
interestsofsimplifyingCommunitylegislationandmaking
itmoreconsistent,thesevariousprovisionsneedtobe
replacedbyuniformprescriptions ,particularlywithregard
toproductswhichmayfallwithingthescopeofseveralof
thesedirectives;
Whereas,initscommunication of15June1989ona
globalapproachtocertificationandtesting(3),the
Commissionproposedthatcommonrulesbedrawnup
concerningaCEconformitymarkingwithasingledesign;
whereas,initsResolutionof21December1989ona
globalapproachtoconformityassessment (4),theCouncil
approvedasaguidingprincipletheadoptionofa
consistentapproachsuchasthiswithregardtotheuseof
theCEmarking;Article1
Directive87/404/EEC(s)onsimplepressurevesselsis
herebyamendedasfollows:
1.Throughoutthetext,'ECmark'isreplacedby'CE
marking'.
2.Article5(1)isamendedtoreadasfollows:
'1.MemberStatesshallpresumethatvessels
bearingtheCEmarkingcomplywithalltheprovisions
ofthisDirective,includingtheconformityassessment
proceduresreferredtoinChapter2.
Conformityofvesselswiththenationalstandards
whichtransposetheharmonizedstandardsthe
referencenumbersofwhichhavebeenpublishedinthe
OfficialJournalofTheEuropeanCommunities shall
resultinapresumption ofconformitywiththe
essentialsafetyrequirementsreferredtoinArticle3.
MemberStatesshallpublishthereferencenumbersof
suchnationalstandards.';(>)OJNoC195,1.8.1992,p.2.
(2)OJNoC136,4.6.1985,p.1.
HOJNoC231,8.9.1989,p.3,andOJNoC267,19.10.
1989,p.3.
(4)OJNoC10,16.1.1990,p.1. (5)OJNoL220,8.8.1987,p.48.

2.2.93 OfficialJournaloftheEuropeanCommunities NoC28/17
theconformityoftheproductwiththerequirementsof
theDirectivebyexaminationandtestingofproducts
onastatisticalbasis,asspecifiedinparagraph4.
4.Statisticalverification
4.1Themanufacturer shallpresenthisproductsin
theformofuniformbatchesandshalltakeall
necessarymeasuresinorderthatthemanufacturing
processensuretheuniformityofeachbatch
produced.3.Thefollowingparagraph3isaddedtoArticle5:
'3,(a)Wherethevesselsaresubjecttoother
directivescoveringotheraspectsandwhich
alsoprovidefortheaffixingoftheCE
marking,thelattershallindicatethatthe
vesselsinquestionarepresumedtoconform
totheprovisionsofthoseotherdirectives.
(b)However,shouldoneormoreofthedirectives
whichapplytothevesselsallowthe
manufacturer ,duringatransitionalperiod,to
choosewhicharrangements toapply,theCE
markingshallindicateconformityonlywith
thedirectivesappliedbythemanufacturer .
(c)Inthiscase,theparticularsofthesaid
directives,aspublishedintheOfficialJournal
oftheEuropeanCommunities ,mustbegiven
inthedocuments ,noticesorinstructions
requiredbythedirectivesandaccompanying
suchvessels.';
4.Article9(1)isamendedtoreadasfollows:
'1.MemberStatesshallinformtheCommission
andtheotherMemberStatesoftheapprovedbodies
responsibleforcarryingoutthecertification
proceduresreferredtoinArticle8(1)and(2)andof
theidentificationnumbersassignedbytheCommission
tothebodiesinvolvedintheproductioncontrolphase.
TheCommissionshall,forinformation ,publishinthe
OfficialJournaloftheEuropeanCommunities alistof
thesebodiesandanyidentification numbersithas
assignedthemandshallensurethatthelistiskeptup
todate.';
5.Article11isamendedtoreadasfollows:
'ECverification
Article11
1.ECverification istheprocedurewherebya
manufacturer orhisauthorizedrepresentative
establishedwithintheCommunityensuresand
declaresthattheproductswhichhavebeencheckedin
accordancewithparagraph3areinconformitywith
thetypedescribedintheECtype-examination
certificateorwiththedesignandmanufacturing
schedulereferredtoinpoint3ofAnnexII.
2.Themanufacturer shalltakeallthenecessary
measuresforthemanufacturing processtoensurethat
theproductsconformtothetypedescribedintheEC
type-examination certificateortothedesignand
manufacturing schedulereferredtoinpoint3of
AnnexII.Themanufacturer orhisauthorized
representative establishedwithintheCommunityshall
affixtheCEmarkingtoeachproductanddrawupa
declarationofconformity .
3.Theapprovedbodyshallcarryoutthe
appropriateexaminations andtestsinordertocheck4.2Thesebatchesshallbeaccompanied bytheEC
type-examination certificatereferredtoinArticle10,
or,wherethevesselsarenotmanufactured in
accordancewithanapprovedprototype,bythedesign
andmanufacturing schedulereferredtoinpoint3of
AnnexII.Inthiscasetheapprovedbodyshall,prior
toECverification ,examinethescheduleinorderto
certifyitsconformity .
4.3Whenabatchisexamined,theinspectionbody
shallensurethatthevesselshavebeenmanufactured
andcheckedinaccordancewiththedesignand
manufacturing scheduleandperformahydrostatictest
orapneumatictestofequivalenteffectoneachvessel
inthebatchatapressurepH1,5timesthevessel's
designpressureinordertocheckitssoundness .The
pneumatictestshallbesubjecttoacceptanceofthetest
safetyproceduresbytheMemberStateinwhichthe
testisperformed .
Moreover,theinspectionbodyshallcarryouttestson
test-piecestakenfromarepresentative production
test-pieceorfromavessel,asthemanufacturer
chooses,inordertoexaminetheweldquality.The
testsshallbecarriedoutonlongitudinalwelds.
However,wheredifferingweldtechniquesareusedfor
longitudinalandcircularwelds,thetestsshallbe
repeatedonthecircularwelds.
Forthevesselsreferredtoinpoint2.1.2ofAnnexI,
thesetestsontest-piecesshallbereplacedbya
hydrostatictestonfivevesselstakenatrandomfrom
eachbatchinordertocheckthattheyconformtothe
requirementsofpoint2.1.2ofAnnexI.
4.4Inthecaseofacceptedbatches,theapproved
bodyshallaffix,orcausetobeaffixed,its
identificationnumbertoeachproductanddrawupa
writtencertificateofconformityrelatingtothetests
carriedout.Allproductsinthebatchmaybeplaced
onthemarketexceptforthoseproductsfromthe
samplewhichwerefoundnottobeinconformity .
Whereabatchisrejectedtheapprovedbodyshalltake
appropriatemeasurestopreventthatbatchfrombeing
placedonthemarket.Intheeventoffrequent
rejectionofbatchestheapprovedbodymaysuspend
statisticalverification .
Themanufacturer may,undertheresponsibilityofthe
approvedbody,affixthelatter'sidentificationnumber
duringthemanufacturing process.

NoC28/18 OfficialJournaloftheEuropeanCommunities 2.2.93
4.5Themanufacturer orhisauthorized
representative mustbeabletosupplyonrequestthe
approvedbody'scertificatesofconformity.';
6.Article15isamendedtoreadasfollows:
'Article15ThevariouscomponentsoftheCEmarking
musthavesubstantiallythesamevertical
dimension,whichmaynotbelessthan
5mm.
(b)Inscriptions
ThevesselordataplatemustbeartheCE
markingprovidedforinArticle16,together
withatleastthefollowinginformation :
—themaximumworkingpressure(PSin
bar)
—themaximumworkingtemperature(Tmax
in°C)
—theminimumworkingtemperature(Tmin
in°C)
—thecapacityofthevessel(VinL)
—thenameormarkofthemanufacturer
—thetypeandserialorbatchidentification
ofthevessel
—thelasttwodigitsoftheyearinwhichthe
productionphasewasinspected.'
Whereadataplateisused,itmustbeso
designedthatitcannotbere-usedandmust
includeavacantspacetoenableother
informationtobeprovided.WithoutprejudicetoArticle7,whereaMemberState
establishesthattheCEmarkinghasbeenaffixed
unduly,themanufacturer orhisauthorized
representative establishedwithintheCommunityshall
beobligedtomaketheproductcomplyandtoendthe
infringementundertheconditionsimposedbythe
MemberState.Wherenon-conformity continues,the
MemberStatemusttakeallappropriatemeasuresto
restrictorprohibittheplacingonthemarketofthe
productinquestionortoensurethatitiswithdrawn
fromthemarket.'
7.ThesecondsubparagraphofArticle16(1)isamended
toreadasfollows:
'TheCEconformitymarkingshallconsistofthe
initials"CE"intheformshowninthemodelin
AnnexII.TheCEmarkingshallbefollowedbythe
distinguishing numberreferredtoinArticle9(1)of
theapprovedinspectionbodyresponsibleforEC
verifications orECsurveillance.'
Article2
8.ThefollowingisaddedtoArticle16(2):
Directive88/378/EEC(x)concerningthesafetyoftoysis
herebyamendedasfollows:
1.Throughoutthetext,"ECmarkisreplacedby"CE
marking".'However,anyothermarkmaybeaffixedtothe
vesselsonthedataplateprovidedthatthevisibility
andlegibilityoftheCEmarkingisnotthereby
reduced.Anyoneholdingatrademarkregisteredina
MemberStatebefore30June1989andactuallyused
whichislikelytobeconfusedwiththeCEmarking
maycontinuetousethatmarkforaperiodof10years
fromthedateofadoptionofthistext.'
9.InAnnexIIpoint1isamendedtoreadasfollows:
'1.CEMARKINGANDINSCRIPTIONS2.Article5(1)isamendedtoreadasfollows:
'1.MemberStatesshallpresumethattoysbearing
theCEmarkinglaiddowninArticle11complywith
alltheprovisionsofthisDirective,includingthe
conformityassessmentproceduresreferredtoin
Articles8,9and10.
Conformityoftoyswiththenationalstandardswhich
transposetheharmonizedstandardsthereference
numbersofwhichhavebeenpublishedintheOfficial
JournaloftheEuropeanCommunities shallresultina
presumptionofconformitywiththeessentialsafety
requirementsreferredtoinArticle3.MemberStates
shallpublishthereferencenumbersofsuchnational
standards.';(a)CEmarking
TheCEconformitymarkingshallconsistof
theinitials"CE"inthefollowingform:
3.Thefollowingparagraph3isaddedtoArticle5:
'3,(a)Wherethetoysaresubjecttootherdirectives
coveringotheraspectswhichalsoprovidefor
theaffixingoftheCEmarking,thelattershall Ifthemarkingisreducedorenlargedthe
proportionsgivenintheabovegraduated
drawingmustberespected. i1)OJNoL187,16.7.1988,p.1.

HOJNoL40,11.2.1989,p.12.2.2.93 OfficialJournaloftheEuropeanCommunities NoC28/19
8.AnewAnnexVisinserted:
'ANNEXV
TheCEconformitymarkingshallconsistoftheinitials
"CE"takingthefollowingform:
Ifthemarkingisreducedorenlargedtheproportions
givenintheabovegraduateddrawingmustbe
respected.
ThevariouscomponentsoftheCEmarkingmusthave
substantiallythesameverticaldimension,whichmay
notbelessthan5mm.'.indicatethatthetoysinquestionare
presumedtoconformtotheprovisionsof
thoseotherdirectives .
(b)However,shouldoneormoreofthese
directivesallowthemanufacturer ,duringa
transitional period,tochoosewhich
arrangements toapply,theCEmarkingshall
indicateconformityonlywiththedirectives
appliedbythemanufacturer .
(c)Particularsofallthesaiddirectives,as
publishedintheOfficialJournalofthe
EuropeanCommunities ,mustbegiveninthe
documents,noticesorinstructionsrequiredby
thedirectivesandaccompanying suchtoysor,
failingthat,ontheirpackaging.';
4.Article9(2)isamendedtoreadasfollows:
'2.MemberStatesshallinformtheCommission
andtheotherMemberStatesoftheapprovedbodies
responsibleforcarryingouttheECtype-examination
referredtoinArticles8(2)and10.
TheCommissionshall,forinformation ,publishalist
ofthesebodiesintheOfficialJournaloftheEuropean
Communitiesandshallensurethatthelistiskeptup
todate.';
5.Article11(2)isamendedtoreadasfollows:
'2.TheCEconformitymarkingshallconsistofthe
initials"CE"takingtheformofthespecimengivenin
AnnexV.';
6.ThefollowingisaddedtoArticle11(3):
'However,anyothermarkmaybeaffixedtothetoys,
theirpackagingoralabelprovidedthatthevisibility
andlegibilityofthe"CE"markingisnotthereby
reduced.
AnyoneholdingatrademarkregisteredinaMember
Statebefore30June1989andactuallyusedwhichis
likelytobeconfusedwiththe"CE"markingmay
continuetousethatmarkforaperiodof10years
fromthedateofadoptionofthistext.';
7.Anewparagraph1(a)isaddedtoArticle12:
'WithoutprejudicetoArticle7,whereaMemberState
establishesthattheCEmarkinghasbeenaffixed
unduly,themanufacturer orhisauthorized
representative establishedwithintheCommunityshall
beobligedtomaketheproductcomplyandtoendthe
infringementundertheconditionsimposedbythe
MemberState.Wherenon-conformity continues,the
MemberStatemusttakeallappropriatemeasuresto
restrictorprohibittheplacingonthemarketofthe
productinquestionortoensurethatitiswithdrawn
fromthemarket.';Article3
Directive89/106/EEC(')onconstructionproductsis
herebyamendedasfollows:
1.Throughoutthetext,'ECmark'isreplacedby'CE
marking'.
2.Article2(2)isamendedtoreadasfollows:
'2,(a)Whenproductsaresubjecttoother
Communitydirectiveswithregardtoother
aspectswhichalsoprovidefortheaffixingof
theCEmarking,thesaidCEconformity
marking,hereinafterreferredtoasthe"CE
marking",referredtoinArticle4(2)shall
indicateinthesecasesthattherequirementsof
thoseotherdirectiveswhichapplytothem
havealsobeencompliedwith.
(b)However,shouldoneormoreofthese
directivesallowthemanufacturer ,duringa
transitional period,tochoosewhich
arrangements toapply,theCEmarkingshall
indicateconformityonlywiththedirectives
appliedbythemanufacturer .
(c)Inthiscase,particularsofthesaiddirectives,
aspublishedintheOfficialJournalofthe
EuropeanCommunities ,mustbegiveninthe
documents,noticesorinstructionsrequired,
bythedirectivesandaccompanying such
products.';
3.Article4(2)isamendedtoreadasfollows:
'2.MemberStatesshallpresumethatproductsare
fitforuseiftheyenableworksinwhichtheyare

NoC28/20 OfficialJournaloftheEuropeanCommunities 2.2.93
Anidentification numbershallbeassignedbythe
Commissiontothebodiesinvolvedintheproduction
controlphase.TheCommissionshall,forinformation ,
publishintheOfficialJournaloftheEuropean
Communities alistofthesebodiesandany
identificationnumbersithasassignedthemandshall
ensurethatthelistiskeptuptodate.';
8.InAnnexIIIpoint4.1isamendedtoreadas
follows:
'4.1CEconformitymarking
TheCEconformitymarkingshallconsistofthe
CEsymbolasgivenbelow:employed,providedthelatterareproperlydesigned
andbuilt,tosatisfytheessentialrequirementsreferred
toinArticle3wheresuchproductsbeartheCE
markingindicatingthattheysatisfyalltheprovisions
ofthisDirective,includingtheconformityprocedures
laiddowninChapterIII.';
4.Article4(6)isamendedasfollows:
Firstsubparagraph :
'TheCEmarkingsignifiesthatproductssatisfythe
requirementsofparagraphs2and4ofthisArticle.It
isforthemanufacturer orhisauthorized
representative establishedwithintheCommunityto
takeresponsibilityforaffixingtheCEmarkingonthe
productitself,onalabelattachedtoit,onits
packaging,orontheaccompanying commercial
documents.';
5.Article15(2)isamendedtoreadasfollows:
'2.WithoutprejudicetoArticle21,wherea
MemberStateestablishesthattheCEmarkinghas
beenaffixedunduly,themanufacturer orhisagent
establishedwithintheCommunityshallbeobligedto
maketheproductcomplyandtoendtheinfringement
underconditionsimposedbytheMemberState.
Wherenon-conformity continues,theMemberState
musttakeallappropriatemeasurestorestrictor
prohibittheplacingonthemarketoftheproductin
questionortoensurethatitiswithdrawnfromthe
market.';
6.Article15(3)isamendedtoreadasfollows:
'3.MemberStatesshalltakethemeasuresnecessary
toprohibittheaffixingtoproductsortheirpackaging
ofmarkswhicharelikelytobeconfusedwiththeCE
marking.However,anyothermarkmaybeaffixedto
theconstructionproductsonalabelfixedtothe
productpackagingorontheaccompanying
commercialdocumentsprovidedthatthevisibilityand
legibilityofthe"CE"markingisnotthereby
reduced.
AnyoneholdingatrademarkregisteredinaMember
Statebefore30June1989andactuallyusedwhichis
likelytobeconfusedwiththe"CE"markingmay
continuetousethatmarkforaperiodof10years
fromthedateofadoptionofthistext.';
7.Article18(1)isamendedtoreadasfollows:
'1.EachMemberStateshallforwardtothe
Commission alistofnamesandaddressesof
certificationbodies,inspectionbodiesandtesting
laboratorieswhichhavebeendesignatedbythat
MemberStatefortaskstobecarriedoutforthe
purposesoftechnicalapprovals,conformity
certifications ,inspectionsandtestsaccordingtothis
Directive .Ifthemarkingisreducedorenlargedthe
proportions givenintheabovegraduated
drawingmustberespected.
ThevariouscomponentsoftheCEmarking
musthavesubstantially thesamevertical
dimension,whichmaynotbelessthan5mm.
Themarkingshallbefollowedbythe
identificationnumberofthebodyinvolvedinthe
production controlstageand,where
appropriate ,indicationstoidentifythe
characteristics oftheproductasafunctionofthe
technicalspecifications .
Additionalinformation
Itshallbeaccompanied bythenameor
identifyingmarkoftheproducer,thelasttwo
digitsoftheyearofmanufactureandthenumber
oftheECcertificateofconformity.'.
Article4
Directive 89/336/EEC(J),onelectromagnetic
compatibility ,asamendedbyDirective92/31/EEC(2),is
herebyamendedasfollows:
1.Throughoutthetext,'ECmark'isreplacedby'CE
marking'.
2.Article3isamendedtoreadasfollows:
''Article3
MemberStatesshalltakeallappropriatemeasuresto
ensurethattheapparatusreferredtoinArticle2may
beplacedonthemarketortakenintoserviceonlyifit
bearstheCEmarkingprovidedforinArticle10
indicatingitsconformitywithalltheprovisionslaid
downbythisDirective,includingthe
HOJNoL139,23.5.1989,p.19.
(2)OJNoL126,12.5.1989,p.11.

2.2.93 OfficialJournaloftheEuropeanCommunities NoC28/21
conformityassessmentprocedureslaiddownin
Article10,whereitisinstalledandusedas
intended.';
3.ThefollowingtextisaddedattheendofArticle
10(1):WhereapparatusisthesubjectofotherDirectives
providingfortheCEconformitymarking,the
affixingoftheCEmarkingshallalsoindicate
conformitywiththeprovisionsofthoseother
Directives .
However,shouldoneormoreofthesedirectives
allowthemanufacturer ,duringatransitional
period,tochoosewhicharrangements toapply,
theCEmarkingshallindicateconformityonly
withthedirectivesappliedbythemanufacturer .
Inthiscase,theparticularsofthesaiddirectives
aspublishedintheOfficialJournalofthe
EuropeanCommunities mustbegiveninthe
documents,noticesorinstructionsrequiredbythe
directivesandaccompanying suchapparatus.
ThevariouscomponentsoftheCEmarkingmust
havesubstantiallythesameverticaldimension,
whichmaynotbelessthan5mm.'.'MemberStatesshalltakethenecessarymeasuresto
prohibittheaffixingtoapparatus,itspackaging,the
instructionsforuseandtheguaranteecertificateof
markswhicharelikelytobeconfusedwiththeEC
mark.However,anyothermarkmaybeaffixedtothe
apparatus,itspackaging,theinstructionsforuseor
theguaranteecertificateprovidedthatthevisibility
andlegibilityofthe"CE"markingisnotthereby
reduced.Anyoneholdingatrademarkregisteredina
MemberStatebefore30June1989andactuallyused
whichislikelytobeconfusedwiththe"CE"marking
maycontinuetousethatmarkforaperiodof10years
fromthedateofadoptionofthistext.';
Article5
4.Anewsubparagraph 7isaddedtoArticle10:
Directive89/392/EEC(*);onmachinery,asamendedby
Directive91/368/EEC(2),isherebyamendedasfollows:
1.Throughoutthetext,'ECmark'isreplacedby'CE
marking'.'7.WithoutprejudicetoArticle9,whereaMember
StateoracompetentauthorityestablishesthattheCE
markinghasbeenaffixedunduly,themanufactureror
hisauthorizedrepresentative establishedwithinthe
Communityshallbeobligedtomaketheproduct
complyandtoendtheinfringementunderconditions
imposedbytheMemberState.Wherenon-compliance
continues,theMemberStatemusttakeallappropriate
measurestorestrictorprohibittheplacingonthe
marketoftheproductinquestionortoensurethatit
iswithdrawnfromthemarket.';2.Thefirstsubparagraph ofArticle5(1)isamendedto
readasfollows:
•f
'MemberStatesshallregardmachineryaccompanied
bytheECdeclarationofconformityreferredtoin
AnnexIIandbearingtheCEmarkingprovidedforin
Article10asconformingtoalltheprovisionsofthis
Directive,includingtheconformityassessment
procedureslaiddowninchapterII.';5.Annex1/2isamendedtoreadasfollows:
3.Article8(5)isamendedtoreadasfollows:
'2.CEconformitymarking
TheCEconformitymarkingshallconsistofthe
initials"CE"takingthefollowingform:'5,(a)Wherethemachineryissubjecttoother
Community Directivesconcerningother
aspectsandwhichalsoprovideforthe
affixingoftheCEmarkingreferredtoin
Article10,thelattershallindicateinthese
casesthatthemachineryalsofulfilsthe
provisionsoftheotherDirectives .
(b)However,shouldoneormoreofthese
directivesallowthemanufacturer ,duringa
transitional period,tochoosewhich
arrangements toapply,theCEmarkingshall
indicateconformityonlywiththedirectives
appliedbythemanufacturer .
IftheCEmarkingisreducedorenlarged,the
proportionsgivenintheabovegraduateddrawing
mustberespected.HOJNoL183,29.6.1989,p.9.
(2)OJNoL198,22.7.1991,p.16.

NoC28/22 OfficialJournaloftheEuropeanCommunities 2.2.93
Ifthemarkingisreducedorenlargedtheproportions
givenintheabovedrawingmustberespected.
ThevariouscomponentsoftheCEmarkingmusthave
substantiallythesameverticaldimension,whichmay
notbelessthan5mm.
Thisminimumdimensionmaybewaivedfor
small-scalemachinery.'.(c)Inthiscase,theparticularsofthesaid
Directives,aspublishedintheOfficial
JournaloftheEuropeanCommunities ,must
begiveninthedocuments,noticesor
instructionsrequiredbythedirectivesand
accompanying suchmachinery.';
4.Article10(1)isamendedtoreadasfollows:
'1.TheCEconformitymarkingshallconsistofthe
initials"CE".Theformofthemarkingtobeusedis
showninAnnexIII.'
5.ThefollowingisaddedtoArticle10(3):
'However,anyothermarkmaybeaffixedtothe
machineryprovidedthatthevisibilityandlegibilityof
the"CE"markingisnottherebyreduced.
AnyoneholdingatrademarkregisteredinaMember
Statebefore30June1989andactuallyusedwhichis
likelytobeconfusedwiththe"EC"markingmay
continuetousethatmarkforaperiodof10years
fromthedateofadoptionofthistext.';
6.Anewparagraph4isaddedtoArticle10:
'4.WithoutprejudicetoArticle7,whereaMember
StateestablishesthattheCEmarkinghasbeenaffixed
unduly,themanufacturer orhisauthorized
representative establishedwithintheCommunityshall
beobligedtomaketheproductcomplyandtoendthe
infringementundertheconditionsimposedbythe
MemberState.Wherenon-conformity continues,the
MemberStatemusttakeallappropriatemeasuresto
restrictorprohibittheplacingonthemarketofthe
productinquestionortoensurethatitiswithdrawn
fromthemarket.';
7.Point1.7.3ofAnnexIisamendedasfollows:
—secondindent:theCEmarking(seeAnnexIII),
—fifthindent:theyearofconstruction .
8.AnnexIIIisamendedtoreadasfollows:
'ANNEXIII
CEMARKING
TheCEconformitymarkingshallconsistoftheinitials
"CE"takingthefollowingform:Article6
Directive89/686/EEC0)onpersonalprotective
equipmentisherebyamendedasfollows:
1.Throughoutthetext,'ECmark'isreplacedby'CE
marking'.
2.Article4(1)isamendedtoreadasfollows:
'1.MemberStatesshallnotprohibit,restrictor
hindertheplacingonthemarketofPPEorPPE
componentswhichbeartheCEmarkingattestingto
theirconformitywithalltheprovisionsofthis
Directive,includingtheconformityassessment
procedureslaiddowninChapterIII.';
3.Anewparagraph6isaddedtoArticle5:
'6,(a)WherethePPEissubjecttootherDirectives
concerningotheraspectsandwhichalso
providefortheaffixingoftheCEmarking
referredtoinArticle13,thelattershall
indicatethatthePPEalsofulfilsthe
provisionsoftheotherDirectives .
(b)However,shouldoneormoreofthese
directivesallowthemanufacturer ,duringa
transitional period,tochoosewhich
arrangementstoapply,theCEmarkingshall
indicatethatthePPEfulfilstheprovisions
onlyofthosedirectivesappliedbythe
manufacturer .
(c)Inthiscase,theparticularsofthese
directives,aspublishedintheOfficial
JournaloftheEuropeanCommunities ,must
begiveninthedocuments,noticesor
instructionsrequiredbythedirectivesand
accompanying suchPPE.';
4.Article9(1)isamendedtoreadasfollows:
'1.MemberStatesshallinformtheCommission
andtheotherMemberStatesoftheapprovedbodies
responsibleforcarryingoutthecertification
proceduresreferredtoinArticle8andofthe
identificationnumbersassignedbytheCommission
tothebodiesinvolvedintheproductioncontrol
phase.TheCommission shall,forinformation ,
publishintheOfficialJournalofthe
HOJNoL399,30.12.1989,p.18.

2.2.93 OfficialJournaloftheEuropeanCommunities NoC28/23
11.AnnexIVisamendedtoreadasfollows: EuropeanCommunities alistofthesebodiesandany
identificationnumbersithasassignedthemandshall
ensurethatthelistiskeptuptodate.'; 'ANNEXIV
CECONFORMITY MARKING
5.TheintroductoryphraseofArticle12isamendedto
readasfollows: TheCEconformitymarkingshallconsistofthe
initials"CE"takingthefollowingform:
'TheECdeclarationofconformityistheprocedure
wherebythemanufacturer orhisauthorized
representative establishedwithintheCommunity.';
6.Article13(1)isamendedtoreadasfollows:
'1.TheCEconformitymarkingshallconsistof
theinitials"CE".Intheeventoftheinvolvementofa
notifiedbodyintheproductioncontrolphaseas
indicatedinArticle11,itsidentificationnumbershall
beadded.
Theformofthemarkingtobeusedisshownin
AnnexIV.';Ifthemarkingisreducedorenlargedtheproportions
givenintheabovegraduateddrawingmustbe
respected.
ThevariouscomponentsoftheCEmarkingmust
havesubstantiallythesameverticaldimension,which
maynotbelessthan5mm.Thisminimum
dimensionmaybewaivedforsmall-scalePPE.
7.Article13(2)isamendedtoreadasfollows:
'2.TheCEmarkingmustbeaffixedtoeachpiece
ofmanufactured PPEortoitspackagingsoastobe
visible,legibleandindeliblethroughouttheexpected
lifeofthePPE.';Additionalinformation :
Thelasttwodigitsoftheyearofmanufactureofthe
PPE.'.
Article7
Directive90/384/EEC(l)onnon-automatic weighing
instrumentsisherebyamendedasfollows:
1.Throughoutthetext,'ECmark'isreplacedby'CE
marking'.
2.Article2(2)isamendedtoreadasfollows:
'1.MemberStatesshalltakeallstepstoensurethat
instrumentsmaynotbebroughtintoserviceforthe
usessetoutinArticle1(2)(a)unlesstheymeetthe
requirementsofthisDirectivewhichapplytothem,
includingtheconformityassessmentprocedures
referredtoinChapterII,andaccordinglybeartheCE
markingprovidedforinArticle10.';
3.Article8(3)isamendedtoreadasfollows:
'3.Wheretheinstrumentsaresubjecttoother
directivescoveringotheraspectswhichalsoprovide
fortheaffixingoftheCEmarking,thelattershall
indicatethattheinstrumentsinquestionarepresumed
toconformtotheprovisionsofthoseother
Directives .
However,shouldoneormoreoftheDirectiveswhich
applytotheinstrumentsallowthemanufacturer ,
duringatransitionalperiod,tochoosewhich
arrangementstoapply,theCEmarkingshallindicate
conformityonlywiththedirectivesappliedbythe
manufacturer .8.ThefollowingisaddedtoArticle13(3):
'However,anyothermarkmaybeaffixedtothePPE
oritspackagingprovidedthatthevisibilityand
legibilityofthe"CE"markingisnottherebyreduced.
AnyoneholdingatrademarkregisteredinaMember
Statebefore30June1989andactuallyusedthe
designofwhichislikelytobeconfusedwiththe
"CE"markingmaycontinuetousethatmarkfora
periodof10yearsfromthedateofadoptionofthis
text.';
9.Anewparagraph4isaddedtoArticle13:
'WithoutprejudicetoArticle7,whereaMember
StateestablishesthattheCEmarkinghasbeen
affixedunduly,themanufacturer orhisauthorized
representative establishedwithintheCommunity
shallbeobligedtomaketheproductcomplyandto
endtheinfringementundertheconditionsimposed
bytheMemberState.Wherenon-conformity
continues,theMemberStatemusttakeall
appropriatemeasurestorestrictorprohibitthe
placingonthemarketoftheproductinquestionor
toensurethatitiswithdrawnfromthemarket.';
10.Anewpoint(h)isaddedtopoint1.4ofAnnexII:
'(h)Whereappropriate ,thereferencesofthe
directivesappliedinaccordancewithArticle5
(6),subparagraph (c).'; (')OJNoL189,20.7.1990,p.1.

NoC28/24 OfficialJournaloftheEuropeanCommunities 2.2.93
'3.ECverification Inthiscase,theparticularsoftheseDirectives,as
publishedintheOfficialJournaloftheEuropean
Communities ,mustbegiveninthedocuments,notices
orinstructionsrequiredbythedirectivesand3.1
accompanying suchinstruments.';
3.24.Article9(1)isamendedtoreadasfollows:
'1.MemberStatesshallinformtheCommission
andtheotherMemberStatesofthebodieswhichthey
havedesignatedtocarryoutthetaskspertainingtothe
procedurereferredtoinArticle8andthespecifictasks
forwhicheachbodyhasbeendesignatedandofthe
notificationnumbersassignedbytheCommissionto
thebodiesinvolvedintheproductioncontrolphase.
TheCommissionshallpublishintheOfficialJournal
oftheEuropeanCommunities alistofthesenotified
bodiestogetherwithanyidentification numbers
assignedtothemandthetasksforwhichtheyhave
beendesignatedandshallensurethatthelistiskeptup
todate.';Thismoduledescribestheprocedure
wherebythemanufacturer orhis
authorizedrepresentative established
withintheCommunity ensuresand
declaresthattheinstruments whichhave
beencheckedinaccordancewithpoint3.3
areinconformitywiththetypedescribed
intheECtype-examination certificateand
satisfytherequirementsoftheDirective
whichapplytothem.
Themanufacturer shalltakeallnecessary
measuresinorderthatthemanufacturing
processensuresconformityofthe
instrumentswiththetypeasdescribedin
theECtype-examination certificateand
withtherequirements oftheDirective
whichapplytothem.Themanufactureror
hisauthorizedrepresentative established
withintheCommunityshallaffixtheCE
markingtoeachinstrument .
Thenotifiedbodyshallcarryoutthe
appropriateexaminations andtestsin
ordertochecktheconformityofthe
productwiththerequirements ofthe
directivebyexaminationandtestingof
everyinstrument,asspecifiedin
point3.5.
ForinstrumentsnotsubjecttoEC
type-approval ,thedocumentsrelatingto
thedesignoftheinstrument,assetoutin
AnnexIII,mustbeaccessibletothe
notifiedbodyshouldthelatterso
request.
Verificationbyexaminationandtestingof3.3 5.ThefollowingisaddedtoArticle10(3):
'However,anyothermarkmaybeaffixedtothe
instrumentsprovidedthatthevisibilityandlegibilityof
the"CE"markingisnottherebyreduced.
AnyoneholdingatrademarkregisteredinaMember
Statebefore30June1989andactuallyusedwhichis
likelytobeconfusedwiththe"CE"markingmay
continuetousethatmarkforaperiodof10years
fromthedateofadoptionofthistext.';3.4
6.Article11isamendedtoreadasfollows:
'Article11 3.5
3.5.1WithoutprejudicetoArticle7,whereaMemberState
establishesthattheCEmarkinghasbeenaffixed
unduly,themanufacturer orhisauthorized
representative establishedwithintheCommunityshall
beobligedtomaketheproductcomplyandtoendthe
infringementundertheconditionsimposedbythe
MemberState.Wherenon-conformity continues,the
MemberStatemusttakeallappropriatemeasuresto
restrictorprohibittheplacingonthemarketofthe
productinquestionortoensurethatitiswithdrawn
fromthemarket.'; 3.5.2everyproduct
Allinstruments shallbeindividually
examinedandappropriatetests,assetout
intherelevantstandard(s )referredtoin
Article5,orequivalenttestsshallbe
carriedoutinordertoverifytheir
conformitywiththetypeasdescribedin
theECtype-examination certificateand
therequirements oftheDirectivethat
applytothem.
Thenotifiedbodyshallaffix,orcauseto
beaffixed,itsidentification numberon
eachapprovedinstrumentanddrawupa
writtencertificateofconformityrelatingto
thetestscarriedout.
Themanufacturer orhisauthorized
representative shallensurethatheisable
tosupplythenotifiedbody'scertificatesof
conformityonrequest.
ECunitverification
ECunitverification istheprocedure
wherebythemanufacturer orhis7.ThefollowingpointsofAnnexIIareamendedtoread
asfollows:
3.5.3 2.1Thirdparagraph :
'TheCEmarkingshallbeaccompanied bythe
identification numberofthenotifiedbody
responsiblefortheECsurveillancereferredtoin
paragraph2.4.';
InAnnexIIpoints3and4areamendedtoreadas
follows :4.
4.1

2.2.93 OfficialJournaloftheEuropeanCommunities NoC28/25
9.AnnexVIisamendedtoreadasfollows:
'ANNEXVI
TheCEconformitymarkingshallconsistoftheinitials
"CE"takingthefollowingform:authorized representative established
withintheCommunity ensuresand
declaresthattheinstrument,generally
designedforaspecificapplication,which
hasbeenissuedwiththecertificate
referredtoinpoint2,conformstothe
requirementsoftheDirectivethatapplyto
it.Themanufacturer orhisauthorized
representative shallaffixtheCEmarking
totheinstrument .
4.2
Ifthemarkingisreducedorenlargedtheproportions
givenintheabovegraduateddrawingmustbe
respected.
ThevariouscomponentsoftheCEmarkingmusthave
substantiallythesameverticaldimension,whichmay
notbelessthan5mm.Thenotifiedbodyshallexaminethe
instrumentandcarryouttheappropriate
tests,assetoutintherespective
standard(s )referredtoinArticle5,or
equivalenttests,inordertoensureits
conformitywiththerelevantrequirements
oftheDirective .
Thenotifiedbodyshallaffix,orcauseto
beaffixed,itsidentificationnumbertothe
approvedinstrumentandshalldrawupa
certificateofconformityconcerningthe
testscarriedout.Additionalinformation :
Thelasttwodigitsoftheyearofinspectionofthe
productionphase.'.
4.3
Article8Theaimofthetechnicaldocumentation
relatingtothedesignoftheinstrument,as
referredtoinAnnexIII,istoenable
conformitywiththerequirementsofthe
Directivetobeassessedandthedesign,
manufacture andoperationofthe
instrumenttobeunderstood .Itmustbe
accessibletothenotifiedbody.';
Point5.3.1isamendedtoreadasfollows:
'5.3.1Directive90/385/EEC(')onactiveimplantablemedical
devicesisherebyamendedasfollows:
1.Throughoutthetext,'CEmark'isreplacedby'CE
marking';
2.Article4(1)isamendedtoreadasfollows:
'1.MemberStatesshallnotpreventtheplacingon
themarketortheputtingintoservicewithintheir
territoryofdevicesbearingtheCEmarkingprovided
forinArticle12whichindicatethattheyhavebeen
thesubjectofanevaluationoftheirconformityin
accordancewiththeprovisionsofArticle9.';
3.Anewparagraph5isaddedtoArticle4:Whereamanufacturer hasoptedfor
executionintwostagesofoneofthe
proceduresmentionedin5.1,andwhere
thesetwostageswillbecarriedoutby
differentparties,aninstrumentwhichhas
undergonethefirststageoftheprocedure
concernedshallcarrytheidentification
numberofthenotifiedbodyinvolvedin
thatstage.';
'5,(a)
Point5.3.4isamendedtoreadasfollows:
'5.3.4TheECmarkingshallbeaffixedtothe
instrumentoncompletionofthesecond
stage,alongwiththeidentificationnumber
ofthenotifiedbodywhichtookpartinthe
secondstage.';(b)Wherethedevicesaresubjecttoother
Directivesconcerningotheraspectsand
whichalsoprovidefortheaffixingoftheCE
marking,thelattershallindicatethatthe
devicesalsofulfiltheprovisionsoftheother
Directives .
However,shouldoneormoreofthese
directivesallowthemanufacturer ,duringa
transitionalperiod,tochoosewhich
arrangementstoapply,theCEmarkingshall
indicatethatthedevicesfulfiltheprovisions
onlyofthosedirectivesappliedbythe
manufacturer .8.InAnnexIVpoint1.1(a),firstandsecond
subparagraphs areamendedtoreadasfollows:
(c)Inthiscase,theparticularsofthese
directives,aspublishedintheOfficial
journaloftheEuropeanCommunities ,theCEconformitymarkingcomprisingtheCE
symbolasdescribedinAnnexVI,
theidentification number(s)ofthenotified
body/bodiesthathas/havecarriedouttheEC
surveillanceortheECverification.'; (>)OJNoL189,20.7.1990,p.17.

NoC28/26 OfficialJournaloftheEuropeanCommunities 2.2.93
mustbegiveninthedocuments,noticesor
instructionsrequiredbythedirectivesand
accompanying suchdevices.';
4.Article11(1)isamendedtoreadasfollows:
'1.MemberStatesshallinformtheCommission
andtheotherMemberStatesofthebodieswhich
theyhavedesignatedtocarryoutthetaskspertaining
totheproceduresreferredtoinArticle9and13and
thespecifictasksforwhicheachbodyhasbeen
designatedandoftheidentificationnumbersassigned
bytheCommissiontothebodiesinvolvedinthe
productioncontrolphase.
TheCommissionshallpublishintheOfficialJournal
oftheEuropeanCommunities thelistofthese
notifiedbodies,togetherwithanyidentification
numbersandthetasksforwhichtheyhavebeen
notifiedandshallensurethatthelistiskeptupto
date.';
5.Thesecondsubparagraph ofArticle12(2)is
amendedtoreadasfollows:
'Itmustbefollowedbytheidentificationnumberof
thenotifiedbodyresponsibleforimplementation of
theproceduressetoutinAnnexesII,IVandV.';8.Annex2isamendedtoreadasfollows:
Point2,secondsubparagraph :
'Themanufacturer orhisauthorizedrepresentative
establishedwithintheCommunityshallaffixtheCE
markinginaccordancewithArticle12andshall
drawupawrittendeclarationofconformity .
Thisdeclarationshallcoveroneormoreidentified
examplesoftheproductandshallbekeptbythe
manufacturer orhisauthorizedrepresentative
establishedwithintheCommunity .
TheCEmarkingshallbeaccompanied bythe
identification numberofthenotifiedbody
responsible.';
9.Annex4isamendedtoreadasfollows:
'ANNEX4
ECVERIFICATION
1.ECverificationistheprocedurewherebythe
manufacturer orhisauthorizedrepresentative
establishedwithintheCommunityensuresand
declaresthattheproductssubjecttothe
provisionsofpoint3areinconformitywiththe
typeasdescribedintheECtype-examination
certificationandsatisfytherequirementsofthe
Directivethatapplytothem.
2.Themanufacturer orhisauthorized
representative established withinthe
Communityshalltakeallmeasuresnecessaryin
orderthatthemanufacturing processensures
conformityoftheproductswiththetypeas
describedintheECtype-examination
certificationandwiththerequirementsofthe
Directivethatapplytothem.Themanufacturer
orhisauthorizedrepresentative established
withintheCommunityshallaffixtheEC
markingtoeachproductanddrawupa
declarationofconformity .
3.Themanufacturer shall,beforethestartof
manufacture ,preparedocumentsdefiningthe
manufacturing processes,inparticularas
regardssterilization ,togetherwithallthe
routine,pre-established provisionstobe
implemented toensureuniformityof
productionandconformityoftheproducts
withthetypeasdescribedintheEC
type-examination certificateaswellaswiththe
relevantrequirementsoftheDirective.
4.Thenotifiedbodyshallcarryoutthe
appropriateexaminationsandtestsinorderto
checktheconformityoftheproductwiththe
requirementsoftheDirectivebyexamination
andtestingofproductsonstatisticalbasis,as
specifiedinpoint6.Themanufacturer must
authorizethenotifiedbodytoevaluatethe
efficiencyofthemeasurestakenpursuantto
Section3,byauditwhereappropriate .
5.Themanufacturer shallundertaketoinstitute
andkeepupdatedapost-marketing surveillance
system.Thisundertakingshallincludethe6.ThefollowingisaddedtoArticle12(3):
'However,anyothermarkmaybeaffixedtothe
packagingortotheinstructionleafletaccompanying
thedeviceprovidedthatthevisibilityandlegibilityof
the"CE"markingisnottherebyreduced.
AnyoneholdingatrademarkregisteredinaMember
Statebefore30June1989andactuallyusedwhichis
likelytobeconfusedwiththe"CE"markingmay
continuetousethatmarkforaperiodof10years
fromthedateofadoptionofthistext.';
7.Article13isamendedtoreadasfollows:
'WithoutprejudicetoArticle7,whereaMember
StateestablishesthattheCEmarkinghasbeen
affixedunduly,themanufacturer orhisauthorized
representative establishedwithintheCommunity
shallbeobligedtomaketheproductcomplyandto
endtheinfringementunderconditionsimposedby
theMemberState.Wherenon-compliance continues,
theMemberStatemusttakeallappropriatemeasures
torestrictorprohibittheplacingonthemarketof
theproductinquestionortoensurethatitis
withdrawnfromthemarket.';

2.2.93 OfficialJournaloftheEuropeanCommunities NoC28/27
Themanufacturer may,underthe
responsibility ofthenotifiedbody,affixthe
latter'sidentification numberduringthe
manufacturing process.
6.5Themanufacturer orhisauthorized
representative shallensurethatheisableto
supplythenotifiedbody'scertificateof
conformityonrequest.'.
10.Annex5isamendedtoreadasfollows:
Point2,secondsubparagraph :'Themanufactureror
hisauthorizedrepresentative establishedwithinthe
CommunityshallaffixtheCEmarkinginaccordance
with...TheCEmarkingshallbeaccompanied by
theidentification numberofthenotifiedbody
responsible.';
11.Annex9isamendedtoreadasfollows:
'ANNEX9
CECONFORMITY MARKING
TheCEconformitymarkingshallconsistofthe
initials"CE"takingthefollowingform:obligationonthepartofthemanufacturerto
notifythecompetentauthoritiesofthe
followingeventsimmediatelyonlearningof
them:
(i)anychangeinthecharacteristics of
performances andanyinaccuraciesinthe
instructionleafletforadevicewhichmight
leadtoorhaveledtothedeathofa
patientordeterioration inhisstateof
health;
(ii)anytechnicalormedicalreasonresulting
inthewithdrawalofadevicefromthe
marketbyamanufacturer .
6.Statisticalverification
6.1Manufacturers shallpresenttheproducts
manufactured intheformofuniformbatches
andshalltakeallnecessarymeasuresinorder
thatthemanufacturing processensuresthe
uniformityofeachbatchproduced.
6.2Arandomsampleshallbedrawnfromeach
batch.Productsinasampleshallbe
individuallyexaminedandappropriatetests,as
setoutinthestandard(s )referredtoin
Article5,orequivalenttestsshallbecarried
outtoensuretheirconformitywiththetypeas
describedintheECtype-examination
certificateandtherebydeterminewhethera
batchisacceptedorrejected.
6.3Statisticalcontrolofproductsshallbebasedon
attributes,entailingasamplingsystemwiththe
followingcharacteristics :
—alevelofqualitycorresponding toa
probabilityofacceptanceof95%,witha
non-conformity percentageofbetween0,29
and1%;Ifthemarkingisreducedorenlargedtheproportions
givenintheabovegraduateddrawingmustbe
respected.
ThevariouscomponentsoftheCEmarkingmust
havesubstantiallythesameverticaldimension,which
maynotbelessthan5mm.
Thisminimumdimensionmaybewaivedfor
small-scaledevices.'.
—alimitqualitycorresponding toa
probabilityofacceptanceof5%,witha
percentageofnon-conformity ofbetween3
and7%.
6.4Wherebatchesareaccepted,thenotifiedbody
shallaffix,orcausetobeaffixed,its
identification numbertoeachproductand
drawupawrittencertificateofconformity
relatingtothetestscarriedout.Allproductsin
thebatchmaybeplacedonthemarketexcept
forthoseproductsfromthesamplewhichwere
foundnottobeinconformity .
Whereabatchisrejected,thenotifiedbody
shalltakeappropriatemeasurestopreventthe
placingonthemarketofthatbatch.Inthe
eventoffrequentrejectionofbatchesthe
notifiedbodymaysuspendthestatistical
verification .Article9
Directive90/396/EEC(l)onappliancesburninggaseous
fuelsisherebyamendedasfollows:
1.Throughoutthetext,'ECmark'isreplacedby'CE
marking';
2.Article4(1)isamendedtoreadasfollows:
'1.MemberStatesmaynotprohibit,restrictor
impedetheplacingonthemarketandtheputtinginto
serviceofapplianceswhichcomplywithallthe
provisionsofthisDirective,includingtheconformity
assessmentprocedureslaiddowninChapter2,and
whichbeartheCEmarkingprovidedforin
Article10.';
(])OJNoL196,26.7.1990,p.15.

NoC28/28 OfficialJournaloftheEuropeanCommunities 2.2.93
3.Article8(5)isamendedtoreadasfollows:
'5,(a)Wheretheappliancesarealsosubjecttoother
Communitydirectiveswhichalsoprovidefor
theaffixingoftheCEmarking:
—theirconformitywiththeprovisionsofthis
Directiveshallbeverifiedinaccordance
withtheprocedureslaiddownin
paragraphs 1and2;anditshallbe
ensuredthattheyalsocomplywiththe
provisionsoftheotherDirectiveswhich
applytotheminaccordancewiththe
procedureslaiddowninthoseDirectives .
TheaffixingoftheCEmarkingasreferredto
inparagraph3shallindicatethatthe
provisionsofalltheDirectiveswhichapplyto
themhavebeencompliedwith.
(b)However,shouldoneormoreofthese
Directivesallowthemanufacturer ,duringa
transitional period,tochoosewhich
arrangements toapply,theCEmarkingshall
indicatethatthedevicesfulfiltheprovisions
onlyofthoseDirectivesappliedbythe
manufacturer .
(c)Inthiscase,theparticularsoftheseDirectives,
aspublishedintheOfficialJournalofthe
EuropeanCommunities ,mustbegiveninthe
documents ,noticesorinstructionsrequiredby
theDirectivesandaccompanying such
devices.';
4.Article9(1)isamendedtoreadasfollows:6.Article11isamendedtoreadasfollows:
'Article11
WithoutprejudicetoArticle7,whereaMemberState
establishesthattheCEmarkinghasbeenaffixed
unduly,themanufacturer orhisauthorized
representative establishedwithintheCommunityshall
beobligedtomaketheproductcomplyandtoendthe
infringementunderconditionsimposedbytheMember
State.Wherenon-compliance continues,theMember
Statemusttakeallappropriatemeasurestorestrictor
prohibittheplacingonthemarketoftheproductin
questionortoensurethatitiswithdrawnfromthe
market.';
7.AnnexIIisamendedtoreadasfollows:
2.1thelastthreesubparagraphs of2(1)should
read:
'Themanufacturer orhisauthorized
representative establishedwithintheCommunity
shallaffixtheCEmarkingoneachapplianceand
drawupawrittendeclarationofconformity .The
declarationofconformitymaycoveroneormore
appliancesandmustbekeptbythe
manufacturer .TheCEmarkingshallbefollowed
bytheidentificationnumberofthenotifiedbody
responsiblefortherandomcheckssetoutin
point2.3.';
3.1thelastthreesubparagraphs of3(1)should
read:
'Themanufacturer orhisauthorized
representative establishedwithintheCommunity
shallaffixtheCEmarkingtoeachapplianceand
drawupawrittendeclarationofconformity .
Thisdeclarationmaycoveroneormore
appliancesandmustbekeptbythe
manufacturer .TheCEmarkingshallbefollowed
bytheidentificationnumberofthenotifiedbody
responsibleforECsurveillance.';
4.1thelastthreesubparagraphs of4(1)should
read:
'Themanufacturer orhisauthorized
representative establishedwithintheCommunity
shallaffixtheCEmarkingtoeachapplianceand
drawupawrittendeclarationofconformity .
Thisdeclarationmaycoveroneormore
appliancesandmustbekeptbythe
manufacturer .TheCEmarkingshallbefollowed
bytheidentificationnumberofthenotifiedbody
responsibleforECsurveillance.';
5.ECVERIFICATION
5.1ECverificationistheprocedurewhereby
themanufacturer orhisauthorized
representative establishedwithinthe
Communityensuresanddeclaresthatthe
productssubjecttotheprovisions'1.MemberStatesshallinformtheCommission
andtheotherMemberStatesofthebodies,hereinafter
calledthe"notifiedbodies",responsibleforcarrying
outtheproceduresreferredtoinArticle8andofthe
identificationnumbersassignedbytheCommissionto
thebodiesinvolvedintheproductioncontrolphase.
TheCommissionshall,forinformation ,publishinthe
OfficialJournaloftheEuropeanCommunities alistof
thesebodiesandanyidentification numbersithas
assignedtothemandshallensurethatthelistiskept
uptodate.';
5.ThefollowingisaddedtoArticle10(2):
'However,anyothermarkmaybeaffixedtothe
apparatusortothedataplateprovidedthatthe
visibilityandlegibilityofthe"CE"markingisnot
therebyreduced.
AnyoneholdingatrademarkregisteredinaMember
Statebefore30June1989andactuallyusedwhichis
likelytobeconfusedwiththe"CE"markingmay
continuetousethatmarkforaperiodof10years
fromthedateofadoptionofthisRegulation.';

2.2.93 OfficialJournaloftheEuropeanCommunities NoC28/29
ofpoint3areinconformitywiththetype
asdescribedintheECtype-examination
certificationandsatisfytherequirements
oftheDirectivethatapplytothem.
5.2Themanufacturer orhisauthorized
representative establishedwithinthe
Community shalltakeallmeasures
necessaryinorderthatthemanufacturing
processensuresconformityofthe
productswiththetypeasdescribedinthe
ECtype-examination certificationand
withtherequirementsoftheDirective
thatapplytothem.Themanufactureror
hisauthorizedrepresentative established
withintheCommunityshallaffixtheEC
markingtoeachproductanddrawupa
declarationofconformity .
5.3Thenotifiedbodyshallcarryoutthe
appropriateexaminations andtestsin
ordertochecktheconformityofthe
productwiththerequirementsofthe
Directivebyexaminationandtestingof
everyproduct,asspecifiedinpoint5.4,
orbyexamination andtestingof
productsonastatisticalbasis,as
specifiedinpoint5.5,atthechoiceofthe
manufacturer .
5.4Verificationbyexaminationandtesting
ofeveryproduct
5.4.1Allproductsshallbeindividually
examinedandappropriatetests,asset
outintherelevantstandard(s)referredto
inArticle5,orequivalenttestsshallbe
carriedoutinordertoverifytheir
conformitywiththetypeasdescribedin
theECtype-examination certificateand
therequirements oftheDirectivethat
applytothem.
5.4.2Thenotifiedbodyshallaffix,orcauseto
beaffixed,itsidentification numberon
eachapprovedproductanddrawupa
writtencertificateofconformityrelating
tothetestscarriedout.
5.4.3Themanufacturer orhisauthorized
representative shallensurethatheisable
tosupplythenotifiedbody'scertificates
ofconformityonrequest.
5.5Statisticalverification
5.5.1Manufacturers shallpresenttheproducts
manufactured intheformofuniform
batchesandshalltakeallnecessary
measuresinorderthatthemanufacturing
processensurestheuniformityofeach
batchproduced.
5.5.2Allproductsshallbeavailablefor
verification intheformofuniform
batches.Arandomsampleshallbe
drawnfromeachbatch.Productsinasampleshallbeindividuallyexamined
andappropriatetests,assetoutinthe
standard(s)referredtoinArticle5,or
equivalenttestsshallbecarriedoutto
ensuretheirconformitywiththetypeas
describedintheECtype-examination
certificateandtherebydeterminewhether
abatchisacceptedorrejected.
5.5.3Statisticalcontrolisasfollows:
Appliancesaresubjecttostatistical
controlbyattributes.Theyshouldbe
groupedintoidentifiable batches
consistingofunitsofasinglemodel
manufactured underthesameconditions .
Abatchisexaminedatrandomintervals.
Theappliancesconstitutingasampleare
examinedindividuallyandappropriate
tests,aslaiddownintherespective
standard(s)referredtoinArticle5,or
equivalenttestsarecarriedoutto
determinewhetherthebatchistobe
acceptedorrejected.Asamplingsystem
withthefollowingcharacteristics is
applied:
—alevelofqualitycorresponding toa
probabilityofacceptanceof95%,
withanon-conformity percentageof
between0,5and1,5%;
—alimitqualitycorresponding toa
probabilityofacceptanceof5%,
withapercentageofnon-conformity
ofbetween5and10%.
5.5.4Wherebatchesareaccepted,thenotified
bodyshallaffix,orcausetobeaffixed,
itsidentificationnumbertoeachproduct
anddrawupawrittencertificateof
conformityrelatingtothetestscarried
out.Allproductsinthebatchmaybe
placedonthemarketexceptforthose
productsfromthesamplewhichwere
foundnottobeinconformity .
Whereabatchisrejected,thenotified
bodyshalltakeappropriatemeasuresto
preventtheplacingonthemarketofthat
batch.Intheeventoffrequentrejection
ofbatchesthenotifiedbodymaysuspend
thestatisticalverification .
Themanufacturer may,underthe
responsibilityofthenotifiedbody,affix
thelatter'sidentification numberduring
themanufacturing process.
5.5.5Themanufacturer orhisauthorized
representative shallensurethatheisable
tosupplythenotifiedbody'scertificates
ofconformityonrequest.

NoC28/30 OfficialJournaloftheEuropeanCommunities 2.2.93
—thetypeofelectricalsupplyused,if
applicable,
—theappliancecategory,
—thelasttwodigitsoftheyearofjnspectionof
theproductionphase.
Informationneededforinstallationpurposesmay
beaddedaccordingtothenatureofthe
appliance.
3.Ifthemarkingisreducedorenlargedthe
proportionsgivenintheabovegraduateddrawing
mustberespected.
ThevariouscomponentsoftheCEmarkingmust
havesubstantiallythesameverticaldimension,
whichmaynotbelessthan5mm.'.6.ECUNITVERIFICATION
6.1ECunitverificationistheprocedure
wherebythemanufacturer orhis
authorizedrepresentative established
withintheCommunityensuresand
declaresthattheproductconcerned,
whichhasbeenissuedwiththecertificate
referredtoinpoint2,conformstothe
requirementsoftheDirectivethatapply
toit.Themanufacturer orhisauthorized
representative shallaffixtheCEmarking
totheproductanddrawupadeclaration
ofconformity .
6.2Thenotifiedbodyshallexaminethe
productandcarryouttheappropriate
tests,assetoutintherespective
standard(s )referredtoinArticle5,or
equivalenttests,inordertoensureits
conformity withtherelevant
requirementsoftheDirective.
Thenotifiedbodyshallaffix,orcauseto
beaffixed,itsidentification numberto
theapprovedproductandshalldrawup
acertificateofconformityconcerningthe
testscarriedout.
6.3Theaimofthetechnicaldocumentation
relatingtothedesignoftheinstrument,
asreferredtoinAnnexIV,istoenable
conformitywiththerequirementsofthe
directivetobeassessedandthedesign,
manufacture andoperationofthe
producttobeunderstood .
Thedesigndocumentation referredtoin
AnnexIVshallbemadeavailabletothe
notifiedbody.
6.4Ifdeemednecessarybythenotifiedbody,
theexaminations andtestsmaybe
carriedoutafterinstallation ofthe
appliance.
8.AnnexIIIisamendedasfollows:
'ANNEX 111
CEMARKING ANDINSCRIPTIONS
1.TheCEmarkingconsistsoftheinitials"CE"as
shownbelow,followedbytheidentification
numberofthenotifiedbodyinvolvedinthe
productioncontrolphase.';Article10
Directive91/263/EEC{l)ontelecommunications
terminalequipment,includingthemutualrecognitionof
theirconformityisherebyamendedasfollows:
1.Throughoutthetext,'CEmark'isreplacedby'CE
marking'.
2.Article3(1)isamendedtoreadasfollows:
'1.MemberStatesshalltakeallappropriate
measurestoensurethatterminalequipmentmaybe
placedonthemarketandputintoserviceonlyifit
bearstheCEmarkingreferredtoinArticle11
attestingtoitsconformitywiththerequirementslaid
downinthisDirective,includingtheconformity
assessmentprocedureslaiddowninChapterIIand
whereitisproperlyinstalledandmaintainedand
usedforitsintendedpurpose.';
3.Anewparagraph4isaddedtoArticle3:
'4,(a)Wheretheterminalequipmentissubjectto
otherdirectivesconcerningotheraspects
whichalsoprovidefortheaffixingoftheCE
marking,thelattershallindicatethatthe
equipmentalsofulfilstheprovisionsofthose
otherDirectives .
(b)However,shouldoneormoreofthese
directivesallowthemanufacturer ,duringa
transitionalperiod,tochoosewhich
arrangementstoapply,theCEmarkingshall
indicatethattheterminalequipmentfulfils
theprovisionsonlyofthosedirectives
appliedbythemanufacturer .
(c)Inthiscase,theparticularsofthese
directives,aspublishedintheOfficial
journaloftheEuropeanCommunities ,must
begiveninthedocuments,notices2.TheapplianceoritsdataplatemustbeartheEC
marktogetherwiththefollowinginscriptions :
—themanufacturer's nameoridentification
symbol,
—thetradenameoftheappliance, 0)OJNoL128,23.5.1991,p.1.

2.2.93 OfficialJournaloftheEuropeanCommunities NoC28/31
orinstructionsrequiredbythedirectivesand
accompanying theterminalequipment.';
4.Article10(1)isamendedtoreadasfollows:AnyoneholdingatrademarkregisteredinaMember
Statebefore30June1989andactuallyusedwhichis
likelytobeconfusedwiththe"CE"markingmay
continuetousethatmarkforaperiodof10years
fromthedateofadoptionofthistext.';
'1.MemberStatesshallinformtheCommission
andtheotherMemberStatesofthebodies
establishedwithintheCommunitywhichtheyhave
designatedforcarryingoutthecertification ,product
checksandassociatedsurveillancetaskspertainingto
theproceduresreferredtoinArticle9andofthe
identificationnumbersassignedbytheCommission
tothebodiesinvolvedintheproductioncontrol
phase.
MemberStatesshallapplytheminimumcriteriaset
outinAnnexVforthedesignationofsuchbodies.
Bodiesthatsatisfythecriteriafixedbytherelevant
harmonizedstandardsshallbepresumedtosatisfy
thecriteriasetoutinAnnexV.';
5.Article10(3)isamendedtoreadasfollows:Article11(4)isamendedasfollows:
—Inthepenultimateline,'theECmarkisreplaced
bytheinitialsCEasindicatedinAnnexVI.';
Article12isamendedtoreadasfollows:
'Article12
WithoutprejudicetoArticle8,whereaMember
StateestablishesthattheCEmarkinghasbeen
affixedunduly,themanufacturer orhisauthorized
representative establishedwithintheCommunity
shallbeobligedtomaketheproductcomplyandto
endtheinfringementundertheconditionsimposed
bytheMemberState.
'3.TheCommissionshallpublishintheOfficial
JournaloftheEuropeanCommunities thelistof
notifiedbodiestogetherwithanyidentification
numberandthelistoftestlaboratoriestogetherwith
thetasksforwhichtheyhavebeendesignatedand
shallensurethislistiskeptuptodate.';
6.Article11(1)isamendedtoreadasfollows:
'1.Themarkingofterminalequipmentcomplying
withthisDirectiveshallconsistoftheCEmarking
consistingofthesymbol"CE",followedbythe
identificationnumberofthenotifiedbodyinvolvedin
theproductioncontrolstageandasymbolindicating
thattheequipmentisintendedandissuitabletobe
connectedtothepublictelecommunications network.
TheformofCEmarkingtobeusedisshownin
AnnexVI,togetherwiththeotherinformation.';
7.ThefollowingisaddedtoArticle11(2):
'However,anyothermarkmaybeaffixedtothe
equipmentprovidedthatthevisibilityandlegibility
ofthe"CE"markingisnottherebyreduced.Wherenon-conformity continues,theMemberState
musttakeallappropriatemeasurestorestrictor
prohibittheplacingonthemarketoftheproductin
questionortoensurethatitiswithdrawnfromthe
market.'
10.AnnexesII(1),lastsentence,III(1),lastsentenceand
IV(1),lastsentence,areamendedasfollows:'The
manufacturer orhisauthorizedrepresentative
establishedwithintheCommunityshallaffixthe
markingsprovidedforinArticle11(1)toeach
productanddrawupawrittendeclarationof
conformitytotype.';
11.AnnexVIisamendedasfollows:
'ANNEXVI
MARKINGFORTHETERMINALEQUIPMENT
REFERREDTOINARTICLE11(1)
TheCEconformitymarkingshallconsistofthe
initials"CE"takingthefollowingform,followed
bytheadditionalinformation referredtoin
Article11(1):
"CEinitials Identification numberofthe
notifiedbodySymbolofsuitabilityfor
connectiontothepublic
telecommunication network

NoC28/32 OfficialJournaloftheEuropeanCommunities 2.2.93
(SeetheOfficialJournaloftheEuropean
Communities forcharacterfont)
Ifthemarkingisreducedorenlargedtheproportions
givenintheabovegraduateddrawingmustbe
respected.
ThevariouscomponentsoftheCEmarkingmust
havesubstantiallythesameverticaldimension,which
maynotbelessthan5mm.';
12.AnnexVIIisamendedasfollows:
'ANNEXVII
MARKINGFORTHEEQUIPMENT REFERREDTOIN
ARTICLE11(4)thelattershallindicatethattheboilersin
questionalsoconformtotheprovisionsof
thoseotherDirectives .
(b)However,shouldoneormoreofthese
directivesallowthemanufacturer ,duringa
transitional period,tochoosewhich
arrangementstoapply,theCEmarkingshall
indicatethattheboilersfulfiltheprovisions
onlyofthosedirectivesappliedbythe
manufacturer .
(c)Inthiscase,theparticularsofthesedirectives,
aspublishedintheOfficialJournalofthe
EuropeanCommunities ,mustbegiveninthe
documents,noticesorinstructionsrequiredby
thedirectivesandaccompanying theboilers.';
4.Asecondsubparagraph isaddedattheendofArticle
74:
'However,anyothermarkmaybeaffixedtothe
boilersandappliancesprovidedthatthevisibilityand
legibilityofthe"CE"markingisnottherebyreduced.
AnyoneholdingatrademarkregisteredinaMember
Statebefore30June1989andactuallyusedwhichis
likelytobeconfusedwiththe"CE'1markingmay
continuetousethatmarkforaperiodof10years
fromthedateofadoptionofthistext.';Ifthemarkingisreducedorenlargedtheproportions
givenintheabovegraduateddrawingmustbe
respected.
ThevariouscomponentsoftheCEmarkingmust
havesubstantiallythesameverticaldimension,which
maynotbelessthan5mm.'.
5.Anewparagraph5isaddedtoArticle7:
'5.WhereaMemberStateoranotifiedbody
establishesthattheCEmarkinghasbeenaffixed
unduly,themanufacturer orhisagentestablished
withintheCommunityshallbeobligedtomakethe
productcomplyandtoendtheinfringementunder
conditionsimposedbytheMemberState,whichmust
takeallappropriatemeasurestorestrictorprohibitthe
placingonthemarketoftheproductinquestionorto
ensurethatitiswithdrawnfromthemarket.';Article11
Directive92/42/EEC(1)onefficiencyrequirements for
newhot-waterboilersfiredwithliquidorgaseousfuelsis
herebyamendedasfollows:
1.Throughoutthetext,'CEmark'isreplacedby'CE
marking'.
2.Article4(1)isamendedtoreadasfollows:
'1.MemberStatesmaynotprohibit,restrictor
impedetheplacingonthemarketorentryintoservice
withintheirterritoriesofappliancesandboilerswhich
beartheCEmarkingprovidedforinArticle7attesting
totheirconformitywithalltheprovisionsofthis
Directive,includingtheconformityassessment
procedureslaiddowninArticles7and8,saveas
otherwiselaiddownintheTreatyorotherDirectives
orCommunityprovisions.';
3.Anewparagraph5isaddedtoArticle4:
'5,(a)Wheretheboilersaresubjecttoother
Directivesconcerningotheraspectswhichalso
providefortheaffixingoftheCEmarking,6.Article8(1)isamendedtoreadasfollows:
'1.MemberStatesshallinformtheCommission
andtheotherMemberStatesofthebodiestheyhave
designatedtocarryoutthetasksrelatingtothe
proceduresreferredtoinArticle7,hereinaftercalled
"notifiedbodies"andoftheidentification numbers
assignedbytheCommissiontothebodiesinvolvedin
theproductioncontrolstage.
TheCommissionshall,forinformation ,publishinthe
OfficialJournaloftheEuropeanCommunities alistof
thesenotifiedbodies,togetherwithanyidentification
numbersandshallensurethatthelistiskeptupto
date.'; (')OJNoL167,22.7.1992,p.17.

2.2.93 OfficialJournaloftheEuropeanCommunities NoC28/33
7.AnnexIisamendedasfollows:
'ANNEX 1
CECONFORMITY MARKING ANDADDITIONAL
SPECIFICMARKINGS
1.CEconformitymarking
TheCEconformitymarkingshallconsistofthe
initials"CE"takingthefollowingform:3.Thefollowingparagraph3isaddedtoArticle8:
'3,(a)Whereelectricalequipmentissubjecttoother
Directivesconcerningotheraspectswhichalso
providefortheaffixingoftheCEmarking,
thelattershallindicatethattheequipmentin
questionalsoconformstotheprovisionsof
thoseotherDirectives .
(b)However,shouldoneormoreofthese
directivesallowthemanufacturer ,duringa
transitional period,tochoosewhich
arrangementstoapply,theCEmarkingshall
indicatethattheelectricalequipmentfulfils
theprovisionsonlyofthosedirectivesapplied
bythemanufacturer .
(c)Inthiscase,theparticularsoftheseDirectives,
aspublishedintheOfficialJournalofthe
EuropeanCommunities ,mustbegiveninthe
documents,noticesorinstructionsrequiredby
thedirectivesandaccompanying theelectrical
equipment.';Ifthemarkingisreducedorenlargedthe
proportionsgivenintheabovegraduateddrawing
mustberespected.
ThevariouscomponentsoftheCEmarkingmust
havesubstantiallythesameverticaldimension,
whichmaynotbelessthan5mm.'
4.Article10isamendedtoreadasfollows:2.Additionalspecificmarkings
Add:
—thelasttwodigitsoftheyearofinspectionof
theproductionphase.';
8.InAnnexIV,point1tomodulesC,DandEthelast
sentenceofeachmoduleisamendedasfollows:'The
manufacturer orhisauthorizedrepresentative
establishedwithintheCommunityshallaffixtheCE
markingtoeachapplianceanddrawupawritten
declarationofconformity.'.'Article10
1.TheCEconformitymarkingreferredtoin
AnnexIIIshallbeaffixedbythemanufacturer orhis
authorizedrepresentative establishedwithinthe
Communitytotheelectricalequipmentor,failingthat,
tothepackaging,theinstructionsheetorthe
guaranteecertificatesoastobevisible,easilylegible
andindelible.
2.Theaffixingonelectricalequipmentofanyother
mark,signorindicationliabletocauseconfusionwith
theCEmarkingshallbeprohibited .However,any
othermarkmaybeaffixedtotheelectricalequipment,
itspackaging,theinstructionsheetortheguarantee
certificateprovidedthatthevisibilityandlegibilityof
the"CE"markingisnottherebyreduced.
AnyoneholdingatrademarkregisteredinaMember
Statebefore30June1989andactuallyusedwhichis
likelytobeconfusedwiththe"CE"markingmay
continuetousethatmarkforaperiodof10years
fromthedateofadoptionofthistext.
3.WithoutprejudicetoArticle9,whereaMember
StateestablishesthattheCEmarkinghasbeenaffixed
unduly,themanufacturer orhisagentestablished
withintheCommunitymarketshallbeobligedto
maketheproductcomplyandtoendtheinfringement
underconditionsimposedbytheMemberState.
Wherenon-compliance continues,theMemberState
musttakeallappropriatemeasurestorestrictorArticle12
Directive73/23/EEC(')onelectricalequipmentdesigned
forusewithincertainvoltagelimitsisherebyamendedas
follows:
1.Thefollowingrecitalisadded:
'WhereasDecision90/683/EEC(*)establishesthe
modulesforthevariousphasesoftheconformity
assessmentprocedureswhichareintendedtobeused
inthetechnicalharmonization Directives,
HOJNoL380,31.12.1990,p.13.';
2.Article8(1)isamendedtoreadasfollows:
'1.Beforebeingplacedonthemarket,theelectrical
equipmentreferredtoinArticle1musthaveaffixedto
ittheCEmarkingprovidedforinArticle10attesting
toitsconformitywithalltheprovisionsofthis
Directive,includingtheconformityassessment
proceduredescribedinAnnexIV.';
(>)OJNoL77,26.3.1973,p.29.

NoC28/34 OfficialJournaloftheEuropeanCommunities 2.2.93
prohibittheplacingonthemarketoftheproductin
questionortoensurethatitiswithdrawnfromthe
market.';
5.Article11:Thesecondsubparagraph isdeleted;
6.AnewAnnexIIIisinserted:
'ANNEXIII
CECONFORMITY MARKINGANDECDECLARATION
OFCONFORMITY
A.CEconformitymarking
TheCEconformitymarkingshallconsistofthe
initials"CE"takingthefollowingform:eachproductanddrawupawrittendeclarationof
conformity .
2.Themanufacturer shallestablishthetechnical
documentation describedinparagraph3andheor
hisauthorizedrepresentative establishedwithinthe
Communityshallkeepitforaperiodendingat
least10yearsafterthelastproducthasbeen
manufactured atthedisposaloftherelevant
nationalauthoritiesforinspectionpurposes.
Whereneitherthemanufacturer norhisauthorized
representative isestablished withinthe
Community ,theobligationtokeepthetechnical
documentation availableshallbetheresponsibility
ofthepersonwhoplacestheelectricalequipment
ontheCommunitymarket.
3.Technical documentation shallenablethe
conformityoftheelectricalequipmentwiththe
requirementsofthedirectivetobeassessed.It
shall,asfarasrelevantforsuchassessment,cover
thedesign,manufactureandoperationofthe
electricalequipment .Itshallinclude:
—ageneraldescriptionoftheelectrical
equipment ;
—alistofthestandardswhichhavebeen
applied;
—theresultsofthetestsandexaminations
carriedout,etc.
4.Themanufacturerorhisauthorizedrepresentative
shallkeepacopyofthedeclarationofconformity
withthetechnicaldocumentation .
5.Themanufacturer shalltakeallmeasuresnecessary
inorderthatthemanufacturing processshall
ensurecomplianceofthemanufactured products
withthetechnicaldocumentation referredtoin
paragraph2andwiththerequirements ofthe
Directivethatapplytothem.'.
Article13
1.MemberStatesshalladoptandpublishbefore1July
1994theprovisionsnecessaryinordertocomplywiththis
Directive.TheyshallinformtheCommissionthereof
forthwithandsenditthenextoftheprovisions
concerned .
Theyshallapplytheseprovisionsfrom1January1995.
WhenMemberStatesadopttheseprovisions,thelatter
shallcontainareferencetothisDirectiveorshallbe
accompanied bysuchareferenceatthetimeoftheir
officialpublication .Theprocedureforsuchreferenceshall
beadoptedbyMemberStates.
2.MemberStatesshallallowtheplacingonthemarket
andthebringingintoserviceofproductsinaccordance
withthemarkingarrangementslaiddownintheDirectives
amendedbythisDirectiveuntil1January1997.IftheCEmarkingisreducedorenlargedthe
proportionsgivenintheabovegraduateddrawing
mustberespected.
ThevariouscomponentsoftheCEmarkingmust
havesubstantiallythesameverticaldimension,
whichmaynotbelessthan5mm.
B.Declarationofconformity
Thedeclarationofconformitymustcontainthe
followingelements:
—nameandaddressofthemanufacturer orhis
authorizedrepresentative establishedwithin
theCommunity ;
—adescriptionoftheelectricalequipment;
—thereferencesofthespecificationswithwhich
conformityisdeclared;
—whereappropriate,referencetothe
harmonizedstandards;
—identification ofthesignatorywhohasbeen
empoweredtoenterintocommitments on
behalfofthemanufacturer orhisauthorized
representative established withinthe
Community.'.;
7.AnewAnnexIVisinserted:
'ANNEXIV
INTERNAL PRODUCTION CONTROL
1.Internalproductioncontrolistheprocedure
wherebythemanufacturer orhisauthorized
representative establishedwithintheCommunity,
whocarriesouttheobligationslaiddownin
point2,ensuresanddeclaresthattheelectrical
equipmentsatisfiestherequirements ofthe
directivethatapplytoit.Themanufacturerorhis
authorizedrepresentative establishedwithinthe
Community shallaffixtheCEmarkingto