23.12.92 OfficialJournaloftheEuropeanCommunities NoC340/7
II
(PreparatoryActs)
COMMISSION
ProposalforaCouncilDirectiveamendingforthesecondtimeDirective83/189/EEClaying
downaprocedurefortheprovisionofinformationinthefieldoftechnicalstandardsand
regulations
(92/C340/10)
COM(92)491final—SYN445
(SubmittedbytheCommissionon27November1992)
THECOUNCILOFTHEEUROPEAN COMMUNITIES ,
HavingregardtotheTreatyestablishingtheEuropean
EconomicCommunity ,andinparticularArticles100a,
213and43thereof,
HavingregardtotheproposalfromtheCommission ,
IncooperationwiththeEuropeanParliament,aresult;whereasanysubsequentnotificationor
communication relatingtotheprogressofnationalacti­
vitiesmustdependontheinterestinsuchactivities
expressedbythosetowhomthisnewsubjecthasalready
beencommunicated ;
WhereastheCommission mustnevertheless beableto
requestthecommunication ofpartorallofthenational
standardization programmessothatitcanreviewthe
developmentofstandardization activityinparticular
economicsectors;
HavingregardtotheopinionoftheEconomicand
SocialCommittee ,
Whereasmeasuresdesignedtoensuretheproperfunc­
tioningortocontinuethedevelopmentoftheinternal
marketafter1January1993shouldbeadopted;
Whereastothisendasmuchtransparency aspossible
shouldbeensuredasregardsnationalinitiativesforthe
establishmentoftechnicalstandardsorregulationsby
amendingtheprocedurefortheprovisionofinformation
laiddowninDirective83/189/EEC;
Whereasinordertoremovebarrierstothesmoothfunc­
tioningoftheSingleMarketthescopeofthesaid
Directiveshouldbeextended;
Whereasinthelightofpastexperiencetheprocedurefor
notifyingtheworkprogrammesofthenationalstan­
dardizationbodiesshouldbeamendedinordertodefine
moreclearlytheinformationwhichhastobenotified
andtomaketheproceduremoreflexibleandless
cumbersome ;
Whereassystematicnotificationisactuallynecessary
onlyinthecaseofnewsubjectsforstandardization and
insofarasthetreatmentofthesesubjectsatnational
levelmaygiverisetodifferencesinnationalstandards
whichareliabletodisturbtheoperationofthemarketasWhereastheEuropeanstandardization systemmustbe
organizedbyandforthepartiesconcerned,onabasisof
coherence,transparency ,openness,consensus,inde­
pendenceofspecialinterests,efficiencyand
decision-making basedonnationalrepresentation ;
Whereasthefunctioningofstandardization inthe
Communitymustbebasedonfundamentalrightsforthe
nationalstandardization bodies,suchasthepossibilityof
obtainingdraftstandards,beinginformedoftheaction
takeninresponsetocommentssubmitted,beingas­
sociatedwithnationalstandardization activitiesor
requestingthepreparationofEuropeanstandardsin
placeofnationalstandards;whereasitisfortheMember
Statestotaketheappropriatemeasuresintheirpowerto
ensurethattheirstandardization bodiesobservethese
rights;
WhereastheprovisionscontainedintheDirective
concerningthestandstillarrangements applicableto
nationalstandardization bodieswhenaEuropean
standardisinpreparationmustbebroughtintolinewith
therelevantprovisionsadoptedbythestandardization
bodieswithintheframeworkoftheEuropeanstandardi­
zationbodies;
Whereas,asfarastechnicalregulationsforproductsare
concerned,themeasuresdesignedtoensuretheproper
functioningorthecontinueddevelopmentofthemarket
includegreatertransparencyofnationalintentionsanda
broadeningofthecriteriaandconditionsforassessing
thepotentialeffectoftheproposedregulationsonthe
market;

NoC340/8 OfficialJournaloftheEuropeanCommunities 23.12.92
Whereasitisthereforenecessarytoassessallthe
requirementslaiddowninrespectofaproductandto
takeaccountofdevelopments innationalpracticesfor
theregulationofproducts;
Whereasrequirements ,otherthantechnicalspecifi­
cations,referringtothelifecycleofaproductafterit
hasbeenplacedonthemarketareliabletoaffectthe
freemovementofthatproductortocreateobstaclesto
theproperfunctioningoftheinternalmarket;
Whereastheimplementation oftheDirectivehas
revealedtheneedtoclarifytheconceptofadefacto
technicalregulation;whereas,inparticular,the
provisionsbywhichthepublicauthorityrefersto
technicalspecifications orotherrequirements ,or
encouragestheobservancethereof,andtheprovisions
referringtoproductswithwhichthepublicauthorityis
associated,inthepublicinterest,havetheeffectof
conferringonsuchrequirementsorspecifications amore
bindingvaluethantheywouldotherwisehavebyvirtue
oftheirprivateorigin;
WhereasexperienceoftheoperationoftheDirectivehas
alsorevealedtheneedtoclarifyorexplaininmoredetail
certaindefinitions,rulesofprocedureorobligationsof
theMemberStatesundertheDirective,without
prejudicetotheirobligationsconcerningtheimplemen­
tationorotherCommunitydirectives;
Whereastheaimoftheinternalmarketistocreatean
environmentthatisconducivetothecompetitiveness of
undertakings ;whereasincreasedprovisionofinfor­
mationisonewayofhelpingundertakingstomakemore
oftheadvantagesofthismarket;whereasitistherefore
necessarytoenableeconomicoperatorstogivetheir
assessmentoftheimpactofthenationaltechnicalregu­
lationsproposedbyotherMemberStatesbyproviding
fortheregularpublicationofthetitlesofnotifieddrafts
andbyamendingtheprovisionsrelatingtotheconfiden­
tialityofsuchdrafts;
WhereastheDirectivelaysupontheMemberStatesclear
andunconditional obligationsdesignedtoensurethat
newtechnicalregulations ,onceadopted,arein
conformitywithCommunitylaw;whereasindividuals
mayenforcetheseobligationsbeforethecourts;whereas
itisthereforeappropriate,intheinterestsoflegal
certainty,thatMemberStatespubliclyannouncethata
nationaltechnicalregulationhasbeenadoptedin
accordancewiththeformalitieslaiddowninthe
Directive;
Whereasitisinherentintheinternalmarketthat,in
particularwheretheprincipleofmutualrecognition
cannotbeimplementedbytheMemberStates,the
Commission proposestheadoptionofbinding
Communityacts;whereasaspecifictemporarystandstill
periodhasbeenestablishedinordertopreventtheintro­
ductionofnationalmeasuresfromcompromising the
adoption,bytheCouncil,ofCommissionproposalsin
thesamefield;Whereasexperiencehasshownthat,inordertobesuited
toitspurpose,thestandstillperiodmustbeprolongedin
ordertomakeadditionalallowanceforthetimetakenby
discussionsintheCouncil;whereas,alsowithaviewto
facilitatingtheadoptionofCommunitymeasuresbythe
Council,MemberStatesshouldrefrainfromadopting
technicalregulationsoncetheCouncilhasadopteda
commonpositionontheCommissionproposal,
HASADOPTEDTHISDIRECTIVE :
Article1
Directive83/189/EECisherebyamendedasfollows:
1.Article1isamendedasfollows:
—paragraph7becomesparagraph 1,
—paragraph 1isreplacedbythefollowingpara­
graphs:
'2."technicalspecification":aspecification
containedinadocumentwhichlaysdownthe
characteristicsrequiredofaproductsuchas
levelsofquality,performance ,safetyor
dimensions,includingtherequirements
applicabletotheproductasregardsthename
underwhichtheproductissold,terminology ,
symbols,testingandtestmethods,packaging,
markingorlabellingandproductionmethods
andprocesses,aswellasconformity
assessmentprocedures ;
3."otherrequirement",arequirement ,other
thanatechnicalspecification ,imposedona
productforthepurposeofprotecting,in
particular,consumersortheenvironmentand
whichaffectsitslifecycleafterithasbeen
placedonthemarket,suchasconditionsof
use,maintenance ,recycling,re-useor
disposal;',
—paragraphs2,3and4becomerespectivelypara­
graphs4,5and6,
—paragraph7isreplacedbythefollowing :
c7.Europeanstandardization body:abody
referredtoinAnnexItothisDirective;'
—thefollowingparagraphsareadded:
'8."nationalstandardization body":abody
referredtoinAnnexIItothisDirective;'
'9."technicalregulation",technicalspecifi­
cationsandotherrequirements ,includingthe
relevantadministrative provisions,the
observanceofwhichiscompulsory,dejureor
defacto,inthecaseofmarketingoruseina

23.12.92 OfficialJournaloftheEuropeanCommunities NoC340/9
MemberStateoramajorpartthereof,aswell
aslaws,regulationsoradministrative
provisions,exceptthoseprovidedforin
Article10ofthisDirective,prohibitingthe
manufacture,importation,marketingoruse
ofaproduct;
Defactotechnicalregulationsinclude:
—laws,regulationsoradministrative
provisionsofaMemberStatewhichrefer
totechnicalspecifications orother
requirementsortoprofessionalcodesor
codesofpracticecontainingthem,or
whichconferoncompliancewithsuch
specifications ,requirementsorcodesa
presumptionofconformitytothe
requirementstheyimpose,
—voluntaryagreementswithwhichapublic
authorityisassociatedandwhichprovide,
inthepublicinterest,forcompliancewith
technicalspecificationsorotherrequire­
ments,excludingpublicprocurement
contracts,
—laws,regulationsoradministrative
provisions,exceptforthoselinkedto
nationalsocialsecuritysystems,referring
toatechnicalspecificationorother
requirementwhich,withoutformally
makingthelattermandatory,encourage
compliancewithit,inparticularbyfiscal
orfinancialmeasures.
Technicalregulationswhichareimposedby
localauthoritiesotherthantheauthoritiesat
thelevelimmediately belowcentral
governmentshallbeexcluded.
10."drafttechnicalregulation",thetextofa
technicalspecificationorotherrequirement,
includingadministrative provisions,formu­
latedwiththeaimofenactingitorofulti­
matelyhavingitenactedasatechnicalregu­
lation,thetextbeingatastageofpreparation
atwhichsubstantialamendmentscanstillbe
made;'byincludingthemintheirstandardization
programme,toprepareoramendastandard,unless
itisthetranspositioninfullofaninternationalor
Europeanstandard;
2.Thisinformationshallindicate,inparticular,
whetherthestandard:
—willtransposeaninternationalorEuropean
standard,incorporating certainnationaldiver­
genciesoramendments,
—willbeanewnationalstandard,
—willamendanationalstandard.
AfterconsultingtheCommitteereferredtoinArticle
5,theCommissionmaydrawuprulesforthe
consolidatedpresentationofthisinformationanda
planandcriteriagoverningthepresentationofthis
informationinordertofacilitateitsevaluation .
3.TheCommissionmayaskforallorpartofthe
standardization programmestobecommunicated to
it.
TheCommission shallmakethisinformation
availabletotheMemberStatesinaformwhich
allowsthedifferentprogrammestobeassessedand
compared .
4.TheCommission shallamendAnnexIIonthe
basisofcommunications fromtheMemberStates.
5.TheCouncilshalldecide,onthebasisofa
proposalfromtheCommission ,onanyamendment
toAnnexI.'
3.Article3isreplacedbythefollowing:
'Article3
Thestandardization bodiesreferredtoinAnnexesI
andII,andtheCommission ,shallbesentalldraft
standardsonrequest;theyshallbekeptinformedby
thebodyconcernedoftheactiontakenonany
commentstheyhavemaderelatingtodrafts.'
4.Article4isreplacedbythefollowing:
'Article4
1.MemberStatesshalltakeallnecessarystepsto
ensurethattheirstandardization bodies:
—communicate informationinaccordancewiththe
provisionsofArticle2andArticle3,
—publishthedraftstandardsinsuchawaythat
commentsmayalsobeobtainedfromparties
establishedinotherStates,2.Article2isreplacedbythefollowing:
'Article2
1.TheCommission andthestandardization
bodiesreferredtoinAnnexesIandIIshallbe
regularlyinformedofthenewsubjectsforwhichthe
nationalbodiesreferredtoinAnnexIIhavedecided,

NoC340/10 OfficialJournaloftheEuropeanCommunities 23.12.92
—granttheotherbodiesreferredtoinAnnexIIthe
righttobeinvolvedpassivelyoractively(by
sendinganobserver)intheplannedactivities,
—donotobjecttoasubjectforstandardization in
theirworkprogrammebeingdiscussedat
Europeanlevelandundertakenoactionwhich
mayprejudiceadecisioninthisregard.
2.MemberStatesshallrefraininparticularfrom
anyactofrecognition,approvalorusebyreference
ofanationalstandardadoptedinbreachofthe
provisionsofArticle2,3and4.'
5.Article7(1)isreplacedbythefollowing :
*1.MemberStatesshalltakeallappropriate
measurestoensurethat,duringthepreparationofa
Europeanstandardreferredtointhefirstindentof
Article6(3)orafteritsapproval,theirstandard­
izationbodiesshallnottakeanyactionwhichcould
prejudicetheharmonization intendedand,in
particular,thattheyshallnotpublishinthefieldin
questionaneworrevisednationalstandardwhichis
notcompletelyinlinewithanexistingEuropean
standard.'extendingitsscope,shorteningthetimetable
originallyenvisagedforimplementation ,adding
specificationsorrequirements ,ormakingthe
lattermorerestrictive .
Where,inparticular,thedraftseekstolimitthe
marketingoruseofachemicalorpharmaceutical
substance,preparationorproductongroundsof
publichealth,oroftheprotectionofconsumers
ortheenvironment ,MemberStatesshallalso
forwardeitherasummaryorthereferencesofall
relevantdatarelatingtothesubstance,prep­
arationorproductconcernedandtoknownand
availablesubstituteproducts,andcommunicate
theanticipatedeffectsofthemeasureonpublic
health,theprotectionoftheconsumerandthe
environment .
TheCommissionshallimmediatelynotifythe
otherMemberStatesofthedraftandall
documentswhichhavebeenforwardedtoit;it
mayalsoreferthisdrafttotheCommittee
referredtoinArticle5and,wherenecessary,to
thecommitteeresponsibleforthefieldin
questionforanopinion.',
—paragraphs 3and4arereplacedbythe
following :
'3.MemberStatesshallcommunicate the
definitivetextofatechnicalregulationtothe
Commissionwithoutdelay.
4.TheinformationsuppliedunderthisArticle
shallbeconfidentialattherequestofthe
notifyingMemberState,supportedbyreasonsin
everycase.',
—thefollowingparagraphisadded:
'5.Whendrafttechnicalregulationsformpart
ofmeasureswhicharerequiredtobe
communicated totheCommission atthedraft
stageunderanotherCommunityact,Member
Statesmaymakeacommunication withinthe
meaningofArticle8(1)ofthisDirectiveunder
thatotheract,providedthattheyformally
indicatethatthesaidcommunication also
constitutesacommunication forthepurposesof
thisDirective .
TheabsenceofareactionfromtheCommission
underthisDirectivetoadrafttechnicalregu­
lationshallnotprejudiceanydecisionwhich
mightbetakenunderotherCommunityacts.'
7.Article9isreplacedbythefollowing :
'Article9
1.MemberStatesshallpostponetheadoptionofa
drafttechnicalregulationforthreemonthsfromthe
dateofthecommunication referredtoinArticle8
(1).6.Article8isamendedasfollows:
—paragraph 1isreplacedbythefollowing:
'1.SubjecttotheprovisionsofArticle10,
MemberStatesshallimmediatelycommunicateto
theCommissionanydrafttechnicalregulation,
exceptwheresuchtechnicalregulationmerely
transposesthefulltextofaninternationalor
Europeanstandard,inwhichcaseinformation
regardingtherelevantstandardshallsuffice;they
shallalsolettheCommissionhaveastatementof
thegroundswhichmaketheenactmentofsucha
technicalregulationnecessary,wheretheseare
notalreadymadeclearinthedraft.
Whereappropriate—andunlessithasalready
beensentwithapriorcommunication —
MemberStatesshallsimultaneously communicate
thetextofthebasislegislativeorregulatory
provisionsprincipallyanddirectlyconcerned,
shouldknowledgeofsuchtextbenecessaryto
assesstheimplicationsofthedrafttechnical
regulation .
MemberStatesshallcommunicatethedraftagain
undertheaboveconditionsiftheymakechanges
tothedraftthathavetheeffectinteraliaof

23.12.92 OfficialJournaloftheEuropeanCommunities NoC340/11
2.Withoutprejudicetoparagraphs3,4and5,
MemberStatesshallpostponetheadoptionofa
drafttechnicalregulationforsixmonthsfromthe
dateofthecommunication referredtoinArticle8
(1)iftheCommissionoranotherMemberState
deliversadetailedopinion,withinthreemonthsof
thatdate,totheeffectthatthemeasureenvisaged
maycreateobstaclestotheproperfunctioningofthe
internalmarket.
TheMemberStateconcernedshallreporttothe
Commissionontheactionitproposestotakeon
suchdetailedopinions.TheCommissionshall
commentonthisreaction.
3.MemberStatesshallpostponetheadoptionofa
drafttechnicalregulationfor12monthsfromthe
dateofthecommunication referredtoinArticle8
(1)if,withinthethreemonthsfollowingthatdate,
theCommissionannouncesitsintentiontopropose
oradoptabindingCommunityactonthismatter.
4.MemberStatesshallpostponetheadoptionofa
drafttechnicalregulationfor18monthsfromthe
dateofthecommunication referredtoinArticle8
(1)if,withinthethreemonthsfollowingthatdate,
theCommissionannouncesitsfindingthatthedraft
technicalregulationconcernsamatterwhichis
coveredbyaproposalpresentedtotheCouncilfora
bindingCommunityact.
5.MemberStatesshallrefrainfromadoptinga
drafttechnicalregulationassoonastheCouncilhas
adoptedacommonpositionontheproposalfrom
theCommission .veryshortspaceoftimeinordertoenactand
introducethemimmediatelywithoutanyconsul­
tationsbeingpossible.TheMemberStateshallgive,
inthecommunication referredtoinArticle8,the
reasonswhichwarranttheurgencyofthemeasures
taken.TheCommission shalldecidewhetherto
acceptorrefusetheurgentprocedurewithinatime
limitofnotmorethanfiveworkingdays.Itshall
takeappropriateactionincaseswhereimproperuse
ismadeofthisprocedure.'
8.Article10isreplacedbythefollowing :
'Article10
Articles8and9shallnotapplytothelaws,regu­
lationsandadministrative provisionsoftheMember
StatesbymeansofwhichMemberStates:
—complywithbindingCommunityactswhich
resultintheadoptionoftechnicalspecifications ,
—fulfiltheobligationsarisingoutofinternational
agreementswhichresultintheadoptionof
commontechnicalspecifications inthe
Community,
—makeuseofsafeguardclausesprovidedforin
bindingCommunityacts,
—applyArticle8(1)ofDirective92/59/EECon
generalproductsafety,
—restrictthemselvestoimplementing ajudgment
oftheCourtofJusticeoftheEuropean
Communities ,
—restrictthemselvestoamendingatechnicalregu­
lationwithinthemeaningofArticle1(9)ofthis
Directive,inconformitywithaCommission
request,withaviewtoremovinganobstacleto
trade.'
9.Article11isreplacedbythefollowing :
'Article11
TheCommissionshallreporteverytwoyearstothe
EuropeanParliamentandtheEconomicandSocial
Committeeontheresultsoftheapplicationofthis
Directive.'
10.Article12isreplacedbythefollowing:
'Article12
1.TheCommissionshallpublishonaregular
basisintheOfficialJournaloftheEuropean
Communities alistoftitlesofthedrafttechnical
regulationswhichhavebeennotifiedtoitpursuant
toArticle8(1).6.Theobligationsreferredtoinparagraphs3,4
and5shalllapseinanyevent:
—whentheCommission informstheMember
Statesthatitnolongerintendstoproposeor
adoptabindingCommunityact,
—whentheCommission informstheMember
Statesofthewithdrawalofitsdraftorproposal,
—whentheCommission ortheCouncilhas
adoptedtheact.
7.Paragraphs 1to5shallnotapplyinthosecases
where,forurgentreasons,occasionedbyseriousand
unforeseeable circumstances ,relatingtothe
protectionofpublichealthorsafety,theprotection
ofanimalsorthepreservationofplants,aMember
Stateisobligedtopreparetechnicalregulationsina

NoC340/12 OfficialJournaloftheEuropeanCommunities 23.12.92
6.FRANCE :
—AFNOR
AssociationFrançaisedeNormalisation
—UTE
UnionTechniquedel'Électricité
7.IRELAND :2.WhereMemberStatesadoptatechnicalregu­
lation,theyshallcontainareferencetothisDirective
orshallbeaccompaniedbysuchareferencewhen
theyarepublishedintheOfficialJournal.
Theproceduresformakingsuchareferenceshallbe
laiddownbytheMemberStates.'
11.TheAnnexisreplacedbythefollowing:
'ANNEXI
Europeanstandardization bodies
—CEN
Comit6EuropéendeNormalisation
—CENELEC—NSAI
NationalStandardsAuthorityofIreland
—ETCI
Electro-Technical CouncilofIreland
8.ITALY:
—UNI
EnteNazionaleItalianodiUnificazione
ComitéEuropéendeNormalisation Electro­
technique—CEI
ComitatoElettrotecnico Italiano
—ETSI
InstitutEuropéendesNormesdeTélécommuni­
cation9.LUXEMBOURG :
—ITM
InspectionduTravailetdesMines
—SEE
Servicedel'Energiedel'État
10.NETHERLANDS :
—NNIANNEXII
Nationalstandardization bodiesintheMemberStatesof
theEuropeanCommunity
1.BELGIUM :
—IBN/BINNederlandsNormalisatie InstituutInstitutBeigedeNormalisation
BelgischInstituutvoorNormalisatie—NEC
NederlandsElektrotechnisch Comite—CEB/BEC
ComitéÉlectrotechnique Belge
BelgischElektrotechnisch Comité11.PORTUGAL :
—IPQ
InstitutoPortuguêsdaQualidade 2.DENMARK :
—DS
DanskStandardiseringsråd
—DEK
DanskElektroteknisk Komité
3.GERMANY :
—DIN
DeutschesInstitutfürNormungeV
—DKE
DeutscheElektrotechnische Kommission im
DINundVDE12.UNITEDKINGDOM :
—BSI
BritishStandardsInstitution
—BEC
BritishElectrotechnical Committee.'
Article2
1.MemberStatesshalltakethemeasuresnecessaryto
complywiththisDirectivenotlaterthan1January1994.
TheyshallforthwithinformtheCommissionthereof.
2.MemberStatesshallcommunicate tothe
Commissionthetextoftheprovisionsofnationallaw
whichtheyadoptinthefieldgovernedbythisDirective.
Article3
ThisDirectiveisaddressedtotheMemberStates.4.GREECE :
—ELOT
HellenicOrganizationforStandardization
5.SPAIN:
—AENOR
AsociaciónEspañoladeNormalización y
Certificación