25.11.93 OfficialJournaloftheEuropeanCommunities NoC318/5
II
(PreparatoryActs)
COMMISSION
ProposalforaCouncilDirectiveonarticlesofpreciousmetal
(93/C318/06)
COM(93)322final—SYN472
(SubmittedbytheCommissionon18October1993)
approachtotechnicalharmonization andstandards(')
andthosedictatedbytheprincipleofsubsidiarity,rules
onarticlesofpreciousmetalshouldbeconfinedto
essentialrequirements ;whereastheserequirementsmust
replacethecorresponding nationalprovisions;
Whereasharmonizedstandardswouldbeusefulinestab­
lishingapresumptionofconformitywiththeessential
requirementsandwithotherprovisions;whereas,at
Communitylevel,suchharmonizedstandardsaredrawn
upbybodiesgovernedbyprivatelawandmustretain
theirstatusofnon-compulsory texts;whereas,tothis
end,theEuropeanCommitteeforStandardization
(CEN)andtheEuropeanCommitteeforElectro­
technicalStandardization (Cenelec)arerecognizedas
thebodiescompetenttoadoptharmonizedstandardsin
accordancewiththegeneralguidelinesoncooperation
betweenthosebodiesandtheCommissionsignedon13
November1984;THECOUNCILOFTHEEUROPEAN UNION,
HavingregardtotheTreatyestablishingtheEuropean
Community,andinparticularArticle100athereof,
HavingregardtotheproposalfromtheCommission ,
IncooperationwiththeEuropeanParliament,
HavingregardtotheopinionoftheEconomicand
SocialCommittee,
Whereasitisimportantthatmeasuresbeadoptedforthe
gradualestablishmentoftheinternalmarket;whereas
theinternalmarketisanareafreeofinternalfrontiersin
whichgoods,persons,servicesandcapitalcanmove
freely;
Whereasthenationaltechnicalrulesapplyingtoarticles
ofpreciousmetalhaveraisedbarrierstothefree
movementofgoods;
Whereas,incompliancewiththeprincipleofsubsi­
diarity,theCommunitybecomesinvolvedonlyifthe
aimsofaproposedmeasurecannotadequatelybe
achievedbymeansofactionatMember-State leveland
maythusbebetterachievedbyactionatCommunity
level;
Whereascertainaspectsofthesectormustthereforebe
harmonized inordertoremovethosebarriersandensure
thefreemovementofarticlesofpreciousmetalwithin
theCommunity ;
Whereasthemeansandmeasuresimplementedbythe
Communityareproportionaltotheaimpursuedand
mustthusberestrictedtotheessentialrequirements ;
whereasthoserequirementsmustreplacethecorres­
pondingnationalprovisions;
Whereasanappropriatelevelofconsumerprotection
andfairtradingneedtobeensuredinthefieldofarticles
ofpreciousmetal;
Whereas,inaccordancewiththeprincipleslaiddownin
theCouncilresolutionof7May1985onanewWhereas,inconfirmingtheappealofinternationalstan­
dardizationwhichgeneratesstandardsthatarein
practiceappliedbyallpartnersininternationaltradeand
whichmeetstherequirementsofCommunitypolicy,the
CommunityinvitestheEuropeanstandardization bodies
tocontinuetheircooperationwiththeinternationalstan­
dardizationorganizations ;
Whereas,forthepurposesofthisDirective,a
harmonizedstandardisatechnicalspecification
(Europeanstandardorharmonization document)
adoptedbyoneorbothofthesebodiesonamandate
fromtheCommission inaccordancewithCouncil
Directive83/189/EECof28March1983layingdowna
procedurefortheprovisionofinformationinthefieldof
technicalstandardsandregulations(2),aslastamended
byDirective88/182/EEC(3),andbyvirtueofthe
abovementioned guidelines;whereas,asregardsany
amendmentstoharmonizedstandards,theCommission
shouldbeassistedbythestandingcommitteesetupby
Directive83/189/EEC;
OOJNoC136,4.6.1985,p.1.
(2)OJNoL109,26.4.1983,p.8.
OOJNoL81,26.3.1988,p.75.

NoC318/6 OfficialJournaloftheEuropeanCommunities 25.11.93
HASADOPTEDTHISDIRECTIVE :
CHAPTER I
Scope,placingonthemarketandfreemovementWhereasmanufacturers shallhavetheoptionofapplying
oneoftheconformityattestationproceduresforeseenby
thisDirectiveandmaycallupononeofthecertification
bodiesamongstthosepublishedbytheCommission ;
whereasMemberStatesmustacceptproductsthathave
satisfiedoneofthecertificationproceduresforeseenby
thisDirective;whereasthesemeansshouldbebasedon
theprovisionsofCouncilDecision90/683/EEC(')and
ensurealevelofqualitysufficienttomeettheneedsof
thoseresponsibleforplacingarticlesontheCommunity
market;whereas,therefore,thesemeansmustalways
involvechecksbyanotifiedbody;whereasthenotifi­
cationofacertificationbodyisanoptionopento
MemberStates,theirdutybeingtoensurethatthe
notifiedbodymeetstheassessmentcriterialaiddownin
thisDirective;Article1
1.ThisDirectivecoversprovisionsrelatingtoindi­
cationofthestandardoffinenessofarticlesofprecious
metal,finishedorsemi-finished ,intendedforthe
ultimateconsumer .
2.
a
(b)
(c)Whereasarticlesmust,asageneralrule,bestruckwitha
finenessmarkandasponsor'smark;whereasthe
finenessmarkindicatesthattheycomplywiththe
provisionsofthisDirective;whereasthereisthereforeno
needforthoseproductstobeartheCEmarking;
whereasthesponsor'smark,registeredintheMember
Statesintheinterestsofdecentralizedmanagement ,must
makeitpossibletoidentifythepersonresponsiblefor
placingthearticleconcernedonthemarket;whereas,
wheremarkingistechnicallydifficult,articlesmustbe
accompaniedbyacertificate;(d)
(e)
(f)ForthepurposesofthisDirective :
preciousmetalsareplatinum,gold,palladiumand
silverinthepurestateandtheiralloys;
anarticleofpreciousmetalisanyitemofjewellery,
goldsmith'swareorwatchmaker'swareandany
otherobjectmadeentirelyorinpartfroma
preciousmetal;
anarticlecomprisingvariouspreciousmetalsisany
itemofjewellery,goldsmith'swareorwatchmaker's
wareandanyotherobjectmadeentirelyorinpart
fromvariouspreciousmetals;
amixedarticleisanarticlecomprisingpartsof
preciousmetalandpartsofbasemetalorother
substances;
analloyofapreciousmetalisasolidsolutionofa
preciousmetalandoneormoreothermetals;
standardoffinenessisthefineprecious-metal
contentexpressedinpartsperthousandinrelation
tothetotalmassofthealloyconcerned;
thenominalstandardoffinenessisthestandardof
finenessofthealloyshownbyapunchedmarkon
thearticleorenteredontheCommunitycertificate
ofconformity;
apreciousmetalcoatingisacoatofpreciousmetal
appliedtoallorpartofanobjectbyachemical,
electrochemical ,mechanicalorphysicalprocess;
themanufacturer isthepersonwhoassumesrespon­
sibilityforthemanufactureofthearticleswhichhe
placesontheCommunitymarketunderhisown
name,andfortheircompliancewiththeapplicable
provisions;
theimporteristhepersonwhoplacesaqualifying
articlefromathirdcountryontheCommunity
market;Whereas,toensurethetransparencyofthemarket,the
numberofstandardswhichmaybeusedforeach
preciousmetalshouldberestricted;whereasitwould
thereforebeexpedienttotakeaccountofexistinginter­
nationalstandardsandofpracticesintheMember
States;(g)
(h) Whereasadistinctivesignhasbeenlaiddownforeach
preciousmetalinorderthatthetypeofmetalusedmay
beidentified;whereasthesponsor'smarkmustbe
accompaniedbyasmallletter'e',identifyingarticles
whichcomplywiththeprovisionsofthisDirective;(0
Whereasinformationgiveninmarksisincodedform;
whereas,accordingly,MemberStatesneedtotake
appropriatestepstoprovideclearinformationtothe
purchaseratthepointofultimatesale;0)
(k)
Whereasthereshouldbeatransitionalperiodforthe
disposalofstocksofarticlesmanufactured inaccordance
withnationalrulesinforceonthedateofadoptionof
theDirective,(1)theauthorizedrepresentative isthenaturalorlegal
personestablishedwithintheCommunitywho,
explicitlydesignatedbythemanufacturer ,actson
behalfofthelatterinperformingdulydefinedtasks;
thepersonresponsibleforplacingarticlesonthe
marketisanynaturalorlegalpersonestablished
withintheCortimunitywhoassumesresponsibility
fortheconformitywiththeapplicableprovisionsof
thearticleswhichheplacesontheCommunity
marketunderhisownname; OOJNoL380,31.12.1990,p.13.

25.11.93 OfficialJournaloftheEuropeanCommunities NoC318/7
(m)placingonthemarketisthefirsttimethatanarticle
ismadeavailableontheCommunitymarket
whetherbywayofpaymentorfreeofcharge,with
aviewtodistributionand/oruseonCommunity
territory;
(n)thesponsor'smarkisthemarkidentifying,onthe
onehand,themanufacturerorpersonresponsible
forplacingarticlesonthemarketand,ontheother,
thenotifiedbodywhichhascheckedtheconformity
ofanarticle;
(o)thefinenessmarkisthemarkindicatingthenominal
standardoffinenessofthepreciousmetal,set
withintheappropriatesurround;
(p)anotifiedbody:abodyresponsibleforcarryingout
theconformityassessmentprocedures .
3.ThisDirectivedoesnotapplyto:
(a)articlesofpreciousmetalfordentalprosthesesor
formedicaluse,asdefinedinCouncilDirective
93/42/EEC(»);
(b)objectsofpreciousmetalforscientificortechnical
use;
(c)musicalinstrumentsorpartsofsuchinstruments
madefrompreciousmetal;
(d)legaltendermadeofpreciousmetalandcollectors'
coinsandmedals;
(e)ingotsorgranulesofpreciousmetalforbanking
use;
(f)objectsmadeofmetalsotherthanpreciousmetal
andcoatedwithpreciousmetal.
4.Articlesmadeofpreciousmetalorcomprising
variouspreciousmetals,finishedorsemi-finished ,are
hereinafterreferredtoas'articles'.
Article2
MemberStatesshalladoptallprovisionstoensurethat,
withregardtoindicationofthestandardoffineness,
onlyarticlescomplyingwiththisDirectivemaybeplaced
onthemarket.
Article3
Articlesmustsatisfytheessentialrequirementswhich
applytothem.ThoserequirementsaresetoutinAnnex
II.
Article4
MemberStatesmaynot,withregardtotheindicationof
thestandardoffineness,prohibit,restrictorhinderthe
placingonthemarketofarticleswhichbearthemarks
referredtoinArticles10and11orwhichareaccom­
paniedbytheCommunitycertificateofconformity
referredtoinArticle13(3).Article5
1.MemberStatesshallpresumearticlestoconformto
thisDirectiveiftheysatisfytherelevantprovisionsofthe
nationalstandardswhichtransposetheharmonized
standardswhosereferencesshallbepublishedinthe
OfficialJournaloftheEuropeanCommunities .
2.MemberStatesshallpublishthereferencestothe
nationalstandardstransposingtheharmonizedstandards
referredtoinparagraph 1,
Article6
WhereaMemberStateortheCommission considers
thatthestandardsreferredtoinArticle5(1)donot
affordconformitywiththecorresponding provisionsof
thisDirective,theCommissionortheMemberState
concernedshallbringthistotheattentionofthe
committeesetupbyDirective83/189/EEC,hereinafter
referredtoas'theCommittee',settingoutthereasons.
TheCommitteeshallgiveanopinionasamatterof
urgency.
TheCommissionshall,inthelightoftheCommittee's
opinion,notifytheMemberStatesastowhetherornot
thestandardsinquestionmustbewithdrawnfromthe
publicationsreferredtoinArticle5(2).
Article7
1.WhereaMemberStatefindsthatarticlesbearing
thefinenessmarkreferredtoinArticle11oraccom­
paniedbytheCommunitycertificateofconformity
referredtoinArticle13(3)donotcorrespondtothe
provisionsofthisDirectiveitshalltakeallappropriate
measurestowithdrawthosearticlesfromthemarketor
toprohibitorrestricttheirbeingplacedonthemarket.
TheMemberStateconcernedshallinformthe
Commission ofsuchmeasuresforthwithandshall
indicatethereasonsforitsdecisionand,inparticular,
whetherthenon-conformity resultsfrom:
(a)non-compliance withtheessentialrequirements
referredtoinArticle3,wherethestandardsreferred
toinArticle5(1)havenotbeenapplied;
(b)incorrectapplicationofthestandardsreferredtoin
Article5(1);
(c)shortcomings inthestandardsreferredtoinArticle5
(1).
2.TheCommissionshallconsultthepartiesconcerned
assoonaspossible.WheretheCommission,afterconsul­
tation,findsthatthemeasuresreferredtoinparagraph 1
arejustified,itshallforthwithinformtheMemberState
whichtookthemeasuresandtheotherMemberStates. (')OJNoL169,12.7.1993,p.1.

NoC318/8 OfficialJournaloftheEuropeanCommunities25.11.93
Wherethedecisionreferredtoinparagraph 1is
attributedtoshortcomings inthestandards,the
Commissionshall,afterconsultingthepartiesconcerned,
referthemattertotheCommitteewithinaperiodoftwo
monthsiftheMemberStatewhichtookthemeasures
intendstomaintainthem,andshallinitiatetheprocedure
referredtoinArticle6.
WheretheCommissionfinds,afterconsultation ,thatthe
measureisunjustifieditshallforthwithinformthe
MemberStatewhichtooktheinitiativethereof,aswell
asthemanufacturerorhisauthorizedrepresentative or
thepersonresponsibleforplacinggoodsonthemarket.
3.TheMemberStateconcernedshalltaketheappro­
priatemeasuresagainstanypersonwhohasimproperly
affixedthefinenessmarkordrawnuptheCommunity
certificateofconformityandshallinformthe
CommissionandtheotherMemberStatesthereof.
4.TheCommission shallensurethattheMember
Statesarekeptinformedoftheprogressandoutcomeof
theprocedure .
CHAPTER II
Conformityattestationprocedures
Article8
1.Beforeplacingthemonthemarket,themanu­
facturerorhisauthorizedrepresentativemustensurethe
conformityofthearticles.Inordertodosohehasthe
optionof:
(a)followingtheprocedurefortheCommunity
declarationofconformitybasedonasystemof
productqualityassuranceasreferredtoinAnnex
III;or
(b)followingtheprocedurefortheCommunity
declarationofconformityreferredtoinAnnexIV;
or
(c)submittingthearticlesforverificationasreferredto
inAnnexV.
2.Theconformityassessmentprocedurereferredtoin
AnnexVmayalsoberequestedbytheperson
responsibleforplacingthearticlesonthemarket.
3.Themanufacturer ,hisauthorizedrepresentativeor,
whereappropriate,thepersonresponsibleforplacing
articlesonthemarketshallselectanotifiedbodyfrom
amongstthosenotifiedpursuanttoArticle9tocarryout
thechecksprescribedinwhicheverconformity
assessmentprocedureisused.
4.Thedossiersandcorrespondence relatingtothe
conformityassessmentproceduresreferredtoin
paragraph 1shallbewritteninanofficiallanguageof
theMemberStateinwhichthenotifiedbodyisestab­
lishedorinalanguageacceptedbythatbody.Article9
1.MemberStatesshallnotifytotheotherMember
StatesandtotheCommissionthebodiesresponsiblefor
carryingouttheproceduresreferredtoinArticle8and
theirspecifictasksinthematter.
TheCommissionshallpublishintheOfficialJournalof
theEuropeanCommunities,forinformation,thelistof
notifiedbodiesandthetasksforwhichtheyhavebeen
notified.TheCommissionshallberesponsiblefor
updatingthislist.
2.MemberStateswhichdesignatecertificationbodies
toimplementtheproceduresspecifiedinArticle8shall
applythecriteriasetoutinAnnexVIforthedesignation
ofthosebodies.Bodieswhichmeettheassessment
criterialaiddowninthenationalstandardswhich
transposetherelevantharmonizedstandardsshallbe
presumedtosatisfythecriteriawhichapplytothem.
3.AMemberStatewhichhasnotifiedabodymust
withdrawthatnotificationifitfindsthatthebodyin
questionnolongersatisfiesthecriteriareferredtoin
paragraph2.ItshallforthwithinformtheotherMember
StatesandtheCommissionthereof.
4.WithoutprejudicetoArticles4and8,Member
Statesarenotobligedtosetupontheirterritorythe
proceduresspecifiedinArticle8.
CHAPTERIII
Marking
Article10
1.Articlesmustbestruckwiththesponsor'smark
beforebeingplacedonthemarket.Thismarkshallbe
accompaniedbyasmallletter£e\
2.Themanufacturerorthepersonresponsiblefor
placingthearticlesonthemarketmustapplytoa
MemberStateforhissponsor'smarktoberegistered
andmust,whereappropriate,communicate toitthe
decisionreferredtoinpoint3.3ofAnnexIII.
3.MemberStatesmustregisterthesponsor'smark
andmakesure,incollaborationwiththeapplicant,that
thereisanunequivocalcorrespondence betweenthat
markandtheapplicant.
Registrationofthesponsor'smarkmustmakeitpossible
toidentifytheapplicant,thenotifiedbodychosenbythe
applicanttoimplementtheproceduresreferredtoin
Article8,theconformityprocedureappliedandthedate
ofregistration .
4.Datarelatingtotheregistrationofsponsor'smarks
shallbemadeavailablebytheMemberStates.

25.11.93 OfficialJournaloftheEuropeanCommunities NoC318/9
CHAPTER IV
LabellingArticle11
Articlesdeemedtosatisfytheessentialrequirements
referredtoinArticle3must,priortobeingplacedonthe
market,bestruckwithoneormorefinenessmarksby
themanufactureror,whereappropriate,byhisauth­
orizedrepresentative ,thepersonresponsibleforplacing
onthemarketorthenotifiedbodywhichcarriedoutthe
varificationreferredtoinArticleV.Article15
MemberStatesshalltaketheappropriatemeasuresto
ensurethatpurchasersareprovidedwithproperinfor­
mationattheplaceofsaletotheultimateconsumer
regardingthestandardoffinenessofarticles,particularly
where,inaccordancewithArticle13,articlesdonot
bearmarks. Thespecificsurroundstobeusedforeachprecious
metal,withinwhichthestandardoffinenessassetoutin
AnnexImustbeindicated,aresetoutinAnnexVII.
CHAPTER V
Finalprovisions Article12
1.Theinformativecontentofthefinenessand
sponsor'smarksandtheletterVmustbevisible,legible
anddurableandatleast0,5mmhigh.Article16
1.Precisegroundsmustbegivenforanydecision
relatingtotheindicationofstandardsoffinenesstaken
byvirtueofthisDirectivewhichresultsinarticlesof
preciousmetalbeingwithdrawnfromthemarketorina
banorrestrictionbeingappliedtotheirbeingplacedon
themarket.2.Existingtraditionalmarksmayalsobestruckon
articlesaslongastheydonotleadtoconfusionwith
finenessmarksorsponsor'smarksortheletterV.
Article13
1.Theobligationtostrikefinenessmarks,sponsor's
marksandtheletter£e'shallnotapplyinrespectof:2.Thedecisionshallbenotifiedtotheparty
concernedassoonaspossible,togetherwithanindi­
cationofthemeansofappealavailableunderthelawsin
forceintheMemberStateinquestionandtheperiod
withinwhichsuchappealmustbemade.
smallarticlesorthosewhicharetoofragileupon
whichitistechnicallydifficulttostrikemarks,
semi-finished articles.
2.Theobligationtostrikethefinenessmarkshallnot
applyinrespectofthosepartsofarticlesconsistingof
variouspreciousmetalsuponwhichitistechnically
difficulttostrikesuchamark.Article17
1.MemberStatesshalladoptandpublishthelaws,
regulationsandadministrative provisionsnecesarryto
complywiththisDirectiveby30June1995atthelatest.
TheyshallforthwithinformtheCommissionthereof.
WhenMemberStatesadopttheseprovisions,theseshall
containareferencetothisDirectiveorshallbeaccom­
paniedbysuchreferenceatthetimeoftheirofficial
publication .Theprocedureforsuchreferenceshallbe
adoptedbyMemberStates.
MemberStatesshallapplytheseprovisionsfrom1
January1996.
2.MemberStatesshallcommunicate tothe
Commissionthetextoftheprovisionsofnationallaw
whichtheyadoptinthefieldcoveredbythisDirective.3.Thearticlesreferredtoinparagraphs 1and2must
beaccompanied byaCommunitycertificateof
conformityissuedbythemanufacturer ,orwhereappro­
priate,byhisauthorizedrepresentative ,theperson
responsibleforplacingonthemarketorthenotified
bodywhichcarriedouttheverificationreferredtoin
AnnexV.Theinformationtobegivenonthecertificate
issetoutinAnnexVIII.
Article142.MemberStatesshall,fortheperiodupto1January
1998,authorizetheplacingonthemarketofarticlesof
preciousmetalwhichareinconformitywiththerulesin
forceontheirterritoryonthedateofadoptionofthis
Directive .Whereitisfoundthatafinenessmarkhasbeenaffixed
improperlyorthataCommunitycertificateof
conformityhasbeenissuedimproperly,thenotifiedbody
whichcheckedtheconformityshalltakethenecessary
measuresandshallforthwithinformtheMemberState
concernedthereof.Thelattershallinformtheother
MemberStatesandtheCommissionthereof.Article18
ThisDirectiveisaddressedtotheMemberStates

NoC318/10 OfficialJournaloftheEuropeanCommunities 25.11.93
ANNEXI
NOMINALSTANDARDS OFFINENESSFORARTICLESOFPRECIOUSMETAL
PreciousmetalsandtheiralloysNominalfineness
(partsperthousand)
Gold 333
375
500
585
750
800
840
916
990
999
Platinum 850
900
950
999
Palladium 500
950
999
Silver 800
835
925
999
ANNEXII
ESSENTIALREQUIREMENTS
1.ArticlesofpreciousmetalcoveredbythisDirectivemustbemanufacturedandmarkedinsuchaway
astominimizetherisktoconsumersofconfusionorfraudinrespectofthepreciousmetalcontent.
2.Articlesmustbearafinenessmarkor,inthecasesreferredtoinArticle13,beaccompaniedbya
Communitycertificateofconformityindicatinganominalstandardoffinenesscorrespondingtoone
ofthestandardssetoutinAnnexI.
Thestandardoffinenessofpreciousmetalsmustbeexpressedinpartsperthousand.
3.Markingandcertificates
3.1.Articlesofasinglepreciousmetalmustbearafinenessmark.
3.2.Articlescomprisingvariouspreciousmetalsmustbeartherelevantfinenessmarkoneachpart.
3.3.Mixedarticlesmustbearthecorresponding finenessmarkonthepartmadeofpreciousmetalorof
variouspreciousmetals.
Partsmadeofnon-preciousmetalmustbeeasilyrecognizableorclearlyidentified.
3.4.InthecasesprovidedforinArticle13(1)and(2),articlesmustbeaccompaniedbyaCommunity
certificateofconformity .
4.Articlesofpreciousmetal,wherecoatedwithothermetals,mustbearthefinenessmarkofthebase
preciousmetalalloy.Theymustalsobearanindicationofthetypeofcoatingorbeaccompaniedbya
documentgivingthatinformationwhereitcannotbeindicatedonthearticle.

25.11.93 OfficialJournaloftheEuropeanCommunities NoC318/11
5.Nonegativetoleranceispermissibleinrelationtothenominalstandardoffineness.Thusagiven
preciousmetalalloyinanarticlemust,withtheexceptionofthesolder,haveastandardoffinenessat
leastequaltothatindicated.
6.Preciousmetalsinanarticlemustbesolderedusinganalloyofthesamestandardoffinenessandof
thesamepreciousmetalastherestofthearticle.Wherethisistechnicallynotpossible,solderingmay
becarriedoutusinganalloyofalowerstandardoffinenessoranothermaterial,
7.Mechanismsorelementsmadeofnon-preciousmetalmaybeusedtosatisfyessentialtechnical
requirements .Wheretheyarevisible,suchmechanismsmustbeeasilyrecognizableorclearlyident­
ified.
ANNEXIII
PRODUCTQUALITYASSURANCE
1.Themanufacturershalloperatetheapprovedqualitysystemforfinalproductcontrolasspecifiedin
point3andshallbesubjecttoinspectionasspecifiedinpoint4.
2.(a)Themanufacturer shallmeettheobligationssetoutinpoint1andshallensureandmakea
declarationtotheeffectthatthearticlesconcernedsatisfytheprovisionsofthisDirectivewhich
applytothem.
Themanufacturer shallstrikeuponthearticlesthefinenessmark,withinthesurroundssetoutin
AnnexVII,andtheregisteredsponsor'smark,togetherwiththeletter'e'andshall,whereappro­
priate,drawupaCommunitycertificateofconformity .
(b)Themanufacturershalldrawupsuchtechnicaldocumentation astopermittheconformityofthe
articleswiththerequirementsoftheDirectivetobeassessed.
Thisdocumentation shallinclude:
—alistofthestandardsreferredtoinArticle5whichareapplied,
—themeansemployedtoensurethequalityofthealloysused,
—whereappropriate,thesolderingmethods.
Themanufacturerorhisauthorizedrepresentative shallkeepthisdocumentation availablefor
inspectionbythenationalauthoritiesforaslongasthedecisionreferredtoinpoints3.3and3.4
remainsvalid.
3.Qualitysystem
3.1.Themanufacturershalllodgeanapplicationfortheassessmentofhisqualitysystemforthearticles
concernedwithasinglenotifiedbodyofhischoice.
Theapplicationshallinclude:
—allappropriateinformationonthearticles,
—thedocumentation relatingtothequalitysystem,
—anundertakingtodischargetheobligationsarisingfromthequalitysystemasapproved,
—anundertakingtomaintaintheapprovedqualitysysteminsuchawaythatitremainsappropriate
andeffective.
3.2.ThequalitysystemmustensurethatthearticlesconformtotherequirementsoftheDirectivewhich
applytothem.
Allprovisionsadoptedbythemanufacturermustbedocumentedinasystematicandorderlymanner
intheformofwrittenmeasures,proceduresandinstructions .Thisqualitysystemdocumentation shall
ensureacommonunderstanding ofthequalityprogrammes ,plans,manualsandrecords.
Itshallcontaininparticularaproperdescriptionof:
—thequalityobjectives,
—theexaminationsandtestswhichwillbecarriedout,
—themeansofmonitoringtheeffectiveoperationofthequalitysystem,
—thequalityrecords.

NoC318/12 OfficialJournaloftheEuropeanCommunities 25.11,93
3.3.Thenotifiedbodyshallauditthequalitysystemtodeterminewhetheritsatisfiestherequirements
referredtoinpoint3.2.Itshallpresumeconformitywiththeserequirementsinrespectofquality
systemswhichimplementtherelevantharmonizedstandard.
Theauditingteamshallincludeatleastonememberwithexperienceinassessingthetechnology
concerned.Theassessmentprocedureshallincludeavisittothemanufacturer'spremises.
Thedecisionshallbenotifiedtothemanufacturer .Itshallcontaintheconclusionsoftheexamination
andthereasonedassessment .
3.4.Themanufacturershallinformthenotifiedbodywhichapprovedthequalitysystemofanyplanto
introducechangesinthequalitysystem.
Thenotifiedbodyshallassesstheproposedmodificationsanddeterminewhetherthemodifiedquality
systemwillstillsatisfytherequirementsreferredtoinpoint3.2orwhetherareassessmentisrequired.
Itshallnotifyitsdecisiontothemanufacturer .Thenotificationshallcontain,whereappropriate,the
conclusionsoftheexaminationandthereasonedassessmentdecision.
4.Inspection
4.1.Thepurposeofinspectionistomakesurethatthemanufacturerdulyfulfilstheobligationsarisingout
oftheapprovedqualitysystem.
4.2.Themanufacturer shallallowthenotifiedbodyaccessforinspectionpurposestotheplacesof
inspection,testingandstorageandshallprovideitwithalltheappropriateinformation .
4.3.Thenotifiedbodyshallperiodicallycarryoutauditstoensurethatthemanufacturer isapplyingthe
qualitysystemandshallprovideanauditreporttothemanufacturer .
5.Administrative provisions
5.1.Themanufacturershallkeepthefollowingatthedisposalofthenationalauthorities :
—thedocumentation referredtoinpoint3.1,
—thedocumentation onthechangesreferredtoinpoint3.4,
—thedecisionsandreportsfromthenotifiedbodywhicharereferredtoinpoints3.3,3.4and4.3.
5.2.Eachnotifiedbodyshallforwardtotheothernotifiedbodiesanyrelevantinformationconcerningthe
issueandwithdrawalofqualitysystemapprovals.
ANNEXIV
COMMUNITY DECLARATION OFCONFORMITY
1.Themanufacturer ,orhisauthorizedrepresentative ,whocarriesouttheobligationslaiddowninpoint2
shallensureandmakeadeclarationtotheeffectthatthearticlesconcernedsatisfytherequirementsof
theDirectivewhichapplytothem.
Themanufacturerorhisauthorizedrepresentative shallstrikeuponthearticlesthefinenessmark,
withinthesurroundsreferredtoinAnnexVII,andtheregisteredsponsor'smarktogetherwiththe
letter'e'orshall,whereappropriate,drawupaCommunitycertificateofconformity .
2.Themanufacturer shalldrawupsuchtechnicaldocumentation astopermittheconformityofthe
productwiththerequirementsoftheDirectivetobeassessed.
Thisdocumentation shallinclude:
—alistofthestandardsreferredtoinArticle5whichareapplied,
—themeansemployedtoensurethequalityofthealloysused,
—whereappropriate,thesolderingmethods.
Themanufacturerorhisauthorizedrepresentativeshallkeepthisdocumentation availableforinspection
bythenationalauthorities .
Whereneitherthemanufacturernorhisauthorizedrepresentative isestablishedwithintheCommunity,
theobligationtokeepthetechnicaldocumentation availableshallfalltothepersonresponsiblefor
placingthearticleonthemarket.

25.11.93 OfficialJournaloftheEuropeanCommunities NoC318/13
3.Themanufacturershalltakeallmeasuresnecessaryinorderthatthemanufacturing processshallensure
complianceofthemanufacturedarticleswiththetechnicaldocumentation referredtoinpoint2and
withtherequirementsoftheDirectivewhichapplytothem.
4.Anotifiedbodychosenbythemanufacturershallcarryoutorhavecarriedoutproductchecksat
randomintervals.Anappropriatesampleofthefinishedarticles,takenonsitebythenotifiedbody,shall
beexaminedandappropriatetestsassetoutintherelevantstandard(s)referredtoinArticle5,or
equivalenttests,shallbecarriedouttochecktheconformityofthearticleswiththerequirementsofthe
Directive.
Inthosecaseswhereoneormoreofthearticlescheckeddoesnotconform,thenotifiedbodyshalltake
appropriatemeasures.
ANNEXV
THIRDPARTYVERIFICATION
1.Verificationistheactbywhichanotifiedbodychecksandatteststhatarticlessatisfytheessential
requirementssetoutinthisDirectivewhichapplytothem.
2.Verificationmaybecarriedouteitherbyexaminationandtestingofeveryproductasspecifiedin
point3orbyexaminationandtestingofproductsonastatisticalbasisasspecifiedinpoint4,atthe
choiceofthemanufacturerorthepersonresponsibleforplacingonthemarket.
3.Verificationbyexaminationandtestingofeveryproduct
3.1.Eachproductbearingtheregisteredsponsor'smarktogetherwiththeletter'e'shallbeexaminedand
appropriatetestsassetoutintherelevantstandardsreferredtoinArticle5,orequivalenttests,shall
becarriedoutinordertoverifyitsconformitywiththeessentialrequirementsoftheDirectivewhich
applytoit.
3.2.Thenotifiedbodyshallstrikethefinenessmark,withinthesurroundssetoutinAnnexVII,uponeach
approvedarticleorshall,whereappropriate,drawupaCommunitycertificateofconformity .
4.Statisticalverification
4.1.Havingtakenallthemeasuresnecessarytoensurethehomogeneityofeachlot,themanufacturer ,his
authorizedrepresentativeorthepersonresponsibleforplacingonthemarketshallpresenthisarticles
intheformofhomogeneous lotsalreadybearingtheregisteredsponsor'smarktogetherwiththeletter
'e\
4.2.Thenotifiedbodyshallstrikethefinenessmark,withinthesurroundssetoutinAnnexVII,uponeach
articleintheacceptedlotorshall,whereappropriate,drawupaCommunitycertificateofconformity
foreachacceptedarticleorforseveralarticles,dulyidentified.
4.3.Articlesshallbesubmittedforstatisticalcheckingbyessentialcharacteristics .Theyshallbegroupedin
identifiablelotsandeachlotshallbechecked.Thearticlesinasampleshallbeindividuallyexamined
andappropriatetestsassetoutintherelevantstandard(s)referredtoinArticle5,orequivalenttests,
shallbecarriedoutinordertodeterminewhetherthelotisacceptedorrejected.
Asamplingplanwiththefollowingoperationalcharacteristics shallbeapplied:
—astandardqualitylevelcorrespondingtoa95%probabilityofacceptancewithanon-conformity
percentageoflessthan1%,
—alimitqualitycorrespondingtoa5°/oprobabilityofacceptancewithanon-conformity percentage
oflessthan5%.
4.4.Ifalotisrejected,thenotifiedbodyshalltakeappropriatemeasurestopreventtheplacingonthe
marketofthatlot.Intheeventoffrequentrejectionoflotsthenotifiedbodymaysuspendthestat­
isticalverification .

NoC318/14 OfficialJournaloftheEuropeanCommunities 25.11.93
ANNEXVI
CRITERIAFORTHEASSESSMENT OFTHEBODIESTOBENOTIFIED
BodiesdesignatedbyMemberStatesmustsatisfythefollowingconditions :
—availabilityofstaffandofthenecessarymeansandequipment,
—technicalcompetenceandprofessionalintegrityofthestaff,
—incarryingouttests,draftingreports,issuingattestationsandcarryingoutinspectionsinaccordance
withthisDirective,themanagementandtechnicalstaffmustbeindependentofallcircles,groupingsor
personswithadirectorindirectinterestintheareaconcerned,
—staffmustbeboundbyprofessionalsecrecy,
—thirdpartyinsurancemustbetakenoutunlesssuchliabilityiscoveredbytheStateundernationallaw.
Theconditionsreferredtointhefirsttwoindentsaboveshallbeperiodicallycheckedbythecompetent
authoritiesoftheMemberStatesorbybodiesdesignatedbytheMemberStates.
ANNEXVII
FINENESS MARKSURROUNDS
I.Thesurroundsspecifictoeachpreciousmetalandwhichmustsurroundthestandardoffinenessofthe
preciousmetalsandtheiralloyssetoutinAnnexIaregivenbelow:
GOLD SILVER PLATINUM PALLADIUM
2.Thestandardoffinenessmustbeindicatedwithinthesesurroundsalongtheaxisofthedashes.
ANNEXVIII
CONTENTS OFCOMMUNITY CERTIFICATE OFCONFORMITY
TheCommunitycertificateofconformitymustbedrawnupinanofficiallanguageoftheMemberStatein
whichthearticlesaremarketedandmustincludethefollowing:
—nameandaddressofthemanufacturerorhisauthorizedrepresentativeorthepersonresponsiblefor
placingonthemarket,
—theletter'e',
—adescriptionofthearticleorofthesemi-finishedarticles,
—thestandardoffinenessinpartsperthousandofthepreciousmetalorpreciousmetalsconcerned,
—thenameandaddressofthenotifiedbodyinvolvedintheconformityattestationproceduresreferredto
inArticle8andtheprocedureapplied.