1992L0042—EN—21.02.2004—002.001—1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE92/42/EEC
of21May1992
onefficiency requirementsfornewhot-waterboilersfiredwithliquidorgaseousfuels
(OJL167,22.6.1992,p.17)
Amendedby:
OfficialJournal
No page date
►M1CouncilDirective93/68/EECof22July1993 L220 1 30.8.1993
►M2Directive 2004/8/EC of the European Parliament and of the Council of
11February2004L52 50 21.2.2004
▼B
COUNCILDIRECTIVE92/42/EEC
of21May1992
on efficiency requirements for new hot-water boilers fired with
liquidorgaseousfuels
THECOUNCILOFTHEEUROPEANCOMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community,andinparticularArticle100athereof,
HavingregardtotheproposalfromtheCommission(1),
IncooperationwiththeEuropeanParliament(2),
Having regard to the opinion of the Economic and Social
Committee(3),
WhereasDecision91/565/EEC(4)providesforthepromotionofenergy
efficiencyintheCommunityundertheSAVEprogramme;
Whereas itisimportant topromote measuresaimed attheprogressive
establishementoftheinternalmarketintheperiodupto31December1992; whereas the internal market encompasses an area withoutinternal frontiers, in which the free circulation of goods, persons,
servicesandcapitalisassured;
Whereas the Council resolution of 15 January 1985 on the improve-
ment of energy-saving programmes in the Member States(
5) invites
MemberStatestopursueandwherenecessary increase theireffortstopromotethemorerationaluseofenergybythefurtherdevelopmentof
integratedenergy-savingpolicies;
Whereas the Council resolution of 16 September 1986 concerns new
Community energy-policy objectives for 1995 and convergence of thepolicies of the Member States(
6), and in particular the objective of
improvingtheefficiencyoffinalenergydemandbyatleast20%;
Whereas Article 130r of the Treaty provides that action by the
Community relating to the environment shall have the objective ofensuringaprudentandrationalutilizationofnaturalresources;
Whereasitisappropriatetotakeasabaseahighlevelofprotectionin
proposals for the approximation of the provisions laid down by law,regulation or administrative action in Member States and concerning
health,safety,environmentalprotectionandconsumerprotection;
Whereas the Council resolution of 21 June 1989 declares ‘that the
Community should take proper account of potential climatic changelinked to the greenhouse effect’(
7) and the Council's conclusions of
29 October 1990 state that CO2emissions in the year 2000 should be
stabilizedthroughouttheCommunityattheir1990level;
Whereas the importance of the domestic and tertiary sector, which
absorbs a major proportion of the final consumption of energy in theCommunity,isconsiderable;
Whereas this sector will become even more important through trends
towards more central heating and a general increase in thermal
comfort;
Whereas better boiler efficiency isin the consumer'sinterest; whereas
energy saving will be reflected in fewer imports of hydrocarbons;whereas reduction in the Community'senergy dependence will have apositiveimpactonitstradebalance;1992L0042—EN—21.02.2004—002.001—2
(1) OJNoC292,22.11.1990,p.8.
(2) OJNoC129,20.5.1991,p.97andOJNoC94,13.4.1992.
(3) OJNoC102,18.4.1991,p.46.
(4) OJNoL307,8.11.1991,p.34.
(5) OJNoC20,22.1.1985,p.1.
(6) OJNoC241,25.9.1986,p.1.
(7) OJNoC183,20.7.1989,p.4.
▼B
Whereas Council Directive 78/170/EEC of 13 February 1978 on the
performance of heat generators for space heating and the productionof hot water in new or existing non-industrial buildings and on the
insulation of heat and domestic hot-water distribution in new non-
industrial builings(
1), has given rise to the establishment of substan-
tially different efficiency levels between one Member State andanother;
Whereas the requirement of high efficiency for hot-water boilers will
reduce the range of technical properties of equipment placed on themarket, thus facilitating series production and making for economiesof scale; whereas the absence of a measure laying down energyrequirements at a sufficiently high level may result, with the comple-
tion of the internal market, in a significant drop in the efficiency
levels of heating installations through the spread on the market oflow-efficiencyboilers;
Whereaslocalclimaticconditionsandtheenergyandoccupancychar-
acteristics of buildings differ greatly within the Community; whereas
MemberStatesmusttakethisdiversityintoaccountwhendeterminingtheconditionsforputtingboilersintoserviceinimplementationofthisDirecitve; whereas these circumstances justify the fact that MemberStates where back-boilers and boilers designed to be installed in theliving space are widely installed at the date of the adoption of this
Directive should continue to authorize, within specific limits, the
placing on their markets and the putting into service of such boilers;whereasthesearrangementsshouldbesubjecttoparticularsurveillancebytheCommission;
WhereasthisDirective,whichisaimedateliminatingtechnicalbarriers
with regard to boiler efficiency, must follow the new approach estab-lished by the Council resolution of 7 May 1985(
2) which specifically
laysdownthat legislative harmonization islimited totheadoption,bymeans of directives based on Article 100 of the EEC Treaty, of the
essential requirements with which products put on the market must
conformand that ‘these essential requirem ents shall be wordedprecisely enough in order to create legally binding obligations whichcan be enforced and to enable the certification bodies to certifyproducts as being in conformity, having regard to those requirementsintheabsenceofstandards’;
HavingregardtoDirective83/189/EEC(
3)layingdownaprocedurefor
the provision of information in the field of technical standards andregulations;
Havingregard toDecision 90/683/EEC(
4)concerning the modules for
the variousphasesofthe conformity assessment procedures whichareintendedtobeusedinthetechnicalharmonizationdirectives;
Whereas boilers complying with the efficiency requirements should
bear the CE mark and, where appropriate, signs in order to enable
themtomovefreelyandtobeputintoserviceinaccordancewiththeirintendedpurposewithintheCommunity;
Having regard to Directive 89/106/EEC(
5) on the approximation of
laws, regulations and administrative provisions of the Member States
relatingtoconstructionproducts;
Whereas efficiency requirements to encourage the rational use of
energy as laid down in Council Directive 90/396/EEC of 29 June
1990 on the approximation of the laws of the Member States relating
to appliances burning gaseous fuels(6) should be established for the
gasboilersreferredtointhisDirective,1992L0042—EN—21.02.2004—002.001—3
(1) OJNoL52,23.2.1978,p.32.DirectiveamendedbyDirective82/885/EEC
(OJNoL378,31.12.1982,p.19).
(2) OJNoC136,4.6.1985,p.1.
(3) OJNoL109,26.4.1983,p.8;DirectivelastamendedbyDecision90/230/
EEC(OJNoL128,18.5.1990,p.15).
(4) OJNoL380,31.12.1990,p.13.
(5) OJNoL40,11.2.1989,p.12.
(6) OJNoL196,26.7.1990,p.15.
▼B
HASADOPTEDTHISDIRECTIVE:
Article 1
This Directive, which comes under the SAVE programme concerning
the promotion of energy efficiency in the Community, determines theefficiency requirements applicable to new hot-water boilers fired byliquid or gaseous fuels with a rated output of no less than 4 kW andnomorethan400kW,hereinaftercalled‘boilers’.
Article 2
ForthepurposesofthisDirective:
—boiler:thecombinedboilerbody-burnerunit,designedtotransmit
towatertheheatreleasedfromburning,
—appliance:
— theboilerbodydesignedtohaveaburnerfitted,
— theburnerdesignedtobefittedtoaboilerbody,
—effective rated output (expressed in kW): the maximum calorific
output laid down and guaranteed by the manufacturer as beingdeliverable duringcontinuousoperationwhilecomplying withthe
usefulefficiencyindicatedbythemanufacturer,
—useful efficiency (expressed in %): the ratio between the heat
output transmitted to the boiler water and the product of the net
calorific value at constant fuel pressure and the consumption
expressedasaquantityoffuelperunittime,
—part load (expressed in %): theratiobetweentheeffective output
ofa boiler operating intermittently oratan output lowerthan the
effectiveratedoutputandthesameeffectiveratedoutput;
—average temperature of the boiler water: theaverageofthewater
temperaturesattheentryandexitoftheboiler,
—standard boiler: aboilerforwhichtheaveragewatertemperature
canberestrictedbydesign,
—back-boiler:a boiler designed to supply a central-heating system
and to be installed in a fireplace recess as part of a back boiler/gasfirecombination,
—low-temperature boiler: a boiler which can work continuously
with a water supply temperature of 35 to 40 ºC, possibly produ-
cing condensation in certain circumstances, including condensing
boilersusingliquidfuel,
—gas condensing boiler: aboilerdesignedtocondensepermanently
alargepartofthewatervapourcontainedinthecombustiongases,
—boiler to be installed in the living space: aboilerwithaneffective
rated output of less than 37 kW, designed to provide heat to the
part of the living space in which it is installed by means of the
emission of heat from the casing having an open expansionchamber, supplying hot water using gravity circulation; suchboilersshallbearontheircasingstheexplicit indication thattheymustbeinstalledinlivingspace.
Article 3
1. ThefollowingshallbeexcludedfromthisDirective:
— hot-waterboilerscapableofbeingfiredbydifferentfuelsincluding
solidfuels,
— equipmentfortheinstantaneouspreparationofhotwater,— boilers designed to be fired byfuels the properties of which differ
appreciably fromthe properties of the liquid and gaseous fuelscommonlymarketed(industrialwastegas,biogas,etc),
— cookers and appliances designed mainly to heat the premises in
which they are installed and, as a subsidiary function, to supplyhotwaterforcentralheatingandsanitaryhotwater,1992L0042—EN—21.02.2004—002.001—4
▼B
— applianceswithratedoutputsoflessthan6kWusinggravitycircu-
lationanddesignedsolelyfortheproductionofstoredsanitaryhotwater,
— boilersmanufacturedonaone-offbasis,
— cogeneration units as defined in Directive 2004/8/EC of the
European Parliament and of the Council of 11 February 2004 onthe promotion ofcogeneration basedonuseful heat demand in theinternalenergymarket(
1).
2. In the case of boilers with a dual function, that of heating
premises andalsoprovidingsanitary hotwater,the efficiency require-
mentsreferredtoinArticle5(1)concerntheheatingfunctiononly.
Article 4
1. MemberStatesmaynotprohibit,restrictorimpedetheplacingon
the market or entry into service within their territories of appliances
and boilers which comply with the provisions of this Directive andwhich bear the CE marking provided for in Article 7 attesting to theconformitytoalltheprovisionsofthisDirective,includingtheconfor-mity assessment procedures laid down in Articles 7 and 8, save asotherwise laid down in the Treaty or other Directives or Community
provisions.
2. Member States shall take all necessary measures to ensure that
boilers cannot be put into service unless they satisfy the efficiencyrequirements set out in Article 5 (1) and the conditions for entry into
service which the Member States lay down on the basis of local
climatic conditions and the energy and occupancy characteristics ofthebuildings.
3. However, Member States where back-boilers and/or boilers that
are to be installed in the living space, are widely installed at the date
of the adoption of the present Directive, shall continue to authorize
their entry into service, provided that their efficiency both at ratedoutputandat30%partloadisnotmorethan4%belowtherequire-mentslaiddowninArticle5(1)forstandardboilers.
4. The effects of the provisions in paragraphs 2 and 3 shall be
constantlymonitoredbytheCommissionandanalysedinthereportto
be submitted under Article 10. To this end the Member States shall
forward to the Commission any information it requires to submit tothe Council the proposed amendments, provided for in that Article,designed to ensure at all events the energy efficiency and free move-mentofboilersintheCommunity.
5 (a) Where the boilers are subject to other Directives concerning
other aspects which also provide for the affixing of the CEmarking, the latter shall indicate that the boilers in question arealsopresumedtoconformtotheprovisionsofthoseotherDirec-
tives.
(b) However,whereoneormoreoftheseDirectivesallowthemanu-
facturer, during a transitional period, to choose which
arrangementstoapply,theCEmarkingshallindicateconformity
to the provisions only of those Directives applied by the manu-facturer. In this case, particulars of the Directives applied, aspublished in the Official Journal of the European Communities ,
mustbegiveninthedocuments,noticesorinstructionsrequiredbytheDirectivesandaccompanyingtheboilers.1992L0042—EN—21.02.2004—002.001—5
(1) OJL52,21.2.2004,p.50.▼M2
▼B
▼M1
▼B
▼M1
▼B
Article 5
1. Boilersmustcomplywiththefollowingusefulefficiencyrequire-
ments:
— atratedoutput,i.e.operatingatratedoutputPnexpressedinkW,at
anaverageboiler-watertemperatureof70ºC,and
— a part load, i.e. operating at 30 % part load, at an average boiler-
watertemperaturewhichvariesaccordingtothetypeoftheboiler.
The useful efficiency requirements to be complied with are set out in
thefollowingtable:
TypeofboilerRangeofpower
outputEfficiencyatratedoutput Efficiencyatpartload
kWAverageboiler-
watertempera-
ture(inºC)Efficiency
requirement
expressed(in
%)Averageboiler-
watertempera-
ture(inºC)Efficiency
requirement
expressed(in%)
Standard
boilers4to400 70 ≥84+2
logPn≥50 ≥80+3
logPn
Low-tempera-
tureboilers(*)4to400 70 ≥87,5+1,5
logPn40 ≥87,5+1,5
logPn
Gasconden-
singboilers4to400 70 ≥91+1
logPn30(**) ≥97+1
logPn
(*) Includingcondensingboilersusingliquidfuels.
(**) Temperatureofboilerwater-supply.
2. The harmonized standards relating to the requirements of this
DirectivedrawnupundermandatefromtheCommissioninaccordance
with Directive 83/189/EEC and 88/182/EEC(1) shall determine, inter
alia, the verification methods valid for production and measurements.
Appropriatetolerancesmustbeincorporatedintheefficiencylevels.
Article 6
1. UndertheprocedureslaiddowninArticle7,MemberStatesmay
decidetoapplyaspecificsystemoflabelsenablingtheenergyperfor-mance of boilers to be clearly ascertained. This system shall apply toboilerstheefficiencyofwhichissuperiortotherequirementsforstan-
dardboilerssetoutinArticle5(1).
Ifitsefficiencyatratedoutputanditsefficiencyatpartloadareequal
toorgreaterthantherelevantvaluesforstandardboilers,aboilershallbeawardedan‘
’assetoutinAnnexI,section2.
Ifitsefficiencyatratedoutputanditsefficiencyatpartloadarethree
or more points higher than the relevant values for standard boilers aboilershallbeawarded‘
’.
Everyextrastepofefficiencyofthreepointsatratedoutputandatpart
loadwillallowtheattributionofanextra‘
 ’assetoutinAnnexII.
2. Member States may not authorize any other label likely to be
confusedwiththosereferredtoinparagraph1.
Article 7
1. Member States shall deem that boilers which comply with the
harmonized standards, the reference numbers of which have been
published in the Official Journal of the European Communities and
forwhichtheMemberStateshavepublishedthereferencenumbersofthenationalstandardstransposingthoseharmonizedstandards,tobeinconformity with the essential efficiency requirements stipulated inArticle 5 (1). Such boilers must bear the ►
M1CE marking ◄1992L0042—EN—21.02.2004—002.001—6
(1) OJNoL81,26.3.1988,p.75.
▼B
referred to in Annex I, section 1, and be accompanied by the EC
declarationofconformity.
2. Theconformityofseries-producedboilersshallbecertifiedby:
— examination of the efficiency of a boiler type in accordance with
moduleBasdescribedinAnnexIII,
— adeclarationofconformitytotheapprovedtypeinaccordancewith
moduleC,DorEasdescribedinAnnexIV.
For boilers burning gaseous fuels, the procedures for assessing the
conformity oftheirefficiency shallbethoseusedtoassessconformityto the safety requirements laid down in Directive 90/396/EEC on theapproximationofthelawsoftheMemberStatesrelatingtoappliancesburninggaseousfuels.
3. When appliances marketed separately are placed on the market,
theymustbearthe ►
M1CEmarking ◄andbeaccompanied bythe
EC declaration of conformity, which defines the parameters enabling
themafter assem bly to achieve the useful efficiency levels laid down
inArticle5(1).
4. TheCEmarkofconformitytotherequirementsofthisDirective
andtotheotherprovisionsconcerningthegrantingoftheCEmarking,
and also the inscriptions specified in Annex I, shall be affixed on
boilers in a visible, easily legible and indelible manner. The affixingon such products of any markingslikely to deceive third parties as tothe meaning and form of the CE marking shall be prohibited. Anyother marking may be affixed to the boilers and appliances provided
that the visibility and legibility of the CE marking is not thereby
reduced.
5. (a) Where a Member State or a notified body establishes that the
CE marking has been affixed unduly, the manufacturer or his
agent established within the Community shall be obliged tomake the boiler comply as regards the provisions concerningthe CE marking and to end the infringement under conditionsimposedbytheMemberState;
(b) where non-compliance continues, the Member State must take
all appropriate measures to restrict or prohibit the placing on
themarketoftheproductinquestionortoensurethatitiswith-drawn from the market, and shall inform the Commission andtheotherMemberStatesaccordingly.
Article 8
1. Member States shall inform the Commission and the other
Member States of the bodies which they have appointed to carry outthe procedures referred to in Article 7, together with specific tasks
whichthesebodieshavebeenappointedtocarryoutandtheidentifica-
tionnumbersassignedtothembeforehandbytheCommission.
TheCommissionshallpublishinthe Official Journal of the European
Communities a list of the notified bodies with their identication
numbersandthetasksforwhichtheyhavebeennotified.TheCommis-sionshallensurethatthislistiskeptuptodate.
2. Member States shall implement the minimum criteria laid down
in Annex V for the appointment of such bodies. Bodies which satisfythecriteria laiddowninthecorrespondingharmonized standardsshallbedeemedtocomplywiththecriterialaiddowninthatAnnex.
3. AMemberStatewhichhasnotifiedaparticular bodymustwith-
draw that notification if it finds that the body concerned no longersatisfies the criteria referred to in paragraph 2. It shall immediatelyinform the other Member States and the Commission accordingly andshallwithdrawthenotification.1992L0042—EN—21.02.2004—002.001—7
▼M1
▼B
▼M1
▼B
▼B
Article 9
1. By 1 January 1993, Member States shall adopt and publish the
provisions necessary to comply with this Directive. They shall forth-
withinformtheCommissionthereof.
Theyshallapplythoseprovisionsfrom1January1994.WhenMemberStatesadoptthoseprovisions,theyshallcontainarefer-
ence tothisDirective orshallbeaccompanied bysuchareference ontheoccasionoftheirofficialpublication.ThemethodsofmakingsuchareferenceshallbelaiddownbytheMemberStates.
2. Until31December1997,MemberStatesshallpermittheplacing
on the market and putting into service of appliances complying withthe national rules and schemes in force within their territories on the
dateoftheadoptionofthisDirective.
Article 10
ThreeyearsaftertheimplementationofthisDirectivetheCommission
shallsubmitareporttotheEuropeanParliamentandtotheCouncilontheresultsachieved.Thatreportshallbeaccompaniedbyproposalsforany changes to be made to this Directive in the light of those resultsandofadvancesintechnology.
Article 11
ThisDirectiveisaddressedtotheMemberStates.1992L0042—EN—21.02.2004—002.001—8
▼M1
ANNEX I
CE CONFORMITY MARKING AND ADDITIONAL SPECIFIC MARK-
INGS
1.CEconformitymarking
The CE conformity marking shall consist of the initials ‘CE’ taking the
followingform:
—
If the CE marking is reduced or enlarged the proportions given in the
abovegraduateddrawingmustberespected.
— The various components of the CE marking must have substantially the
sameverticaldimension,whichmaynotbelessthan5mm.
2.Additionalspecific markings
— ThelasttwodigitsoftheyearinwhichtheECmarkingwasaffixed.
— The energy performance label awarded under Article 6 of this Directive
consistsofthefollowingsymbol:
1992L0042—EN—21.02.2004—002.001—9
▼B
ANNEX II
AWARDOFENERGY-PERFORMANCELABELS
Efficiency requirements to be met both at nominal output and at part-load of
0,3Pn
LabelEfficiencyrequirementat
nominaloutputPnandat
anaverageboiler-water
temperatureof70ºC
%Efficiencyrequirementat
part-loadof0,3Pnandat
anaverageboiler-water
temperatureof ≥50ºC
%
≥84+2logPn ≥80+3logPn
≥87+2logPn ≥83+3logPn
≥90+2logPn ≥86+3logPn
≥93+2logPn ≥89+3logPn1992L0042—EN—21.02.2004—002.001—10
▼B
ANNEX III
ModuleB:ECtype-examination
1. This module describes that part of the procedure by which a notified body
ascertainsandatteststhatanexample,representativeoftheproductionenvi-
saged,meetstherelevantprovisionsoftheDirective.
2. The application for EC type-examination is lodged by the manufacturer or
his authorized representative established within the Community with a noti-
fiedbodyofhischoice.
Theapplicationmustinclude:
— the name and address of the manufacturer and, if the application is
lodgedbytheauthorizedrepresentative,thenameandaddressinaddition,
— awritten declaration thatthe same application hasnot beenlodgedwith
anyothernotifiedbody,
— thetechnicaldocuments,asdescribedinsection3.
The applicant must place at the disposal of the notified body an example
representative of the production envisaged, hereinafter called ‘type’. The
notified body may request further examples if needed for carrying out the
testprogramme.
3. The technical documents must enable the conformity of the appliance with
therequirementsoftheDirectivetobeassessed.Theymust,asfarasisrele-
vantforsuchassessment,coverthedesign,manufactureandoperationofthe
applianceandcontainasfarasisrelevantforassessment:
— ageneraltype-description,
— conceptual design and manufacturing drawings and diagrams of compo-
nents,sub-assemblies,circuits,etc.,
— descriptions and explanations necessary for the understanding of the
drawingsanddiagramsandtheoperationoftheproduct,
— a list of the standards referred to in Article 5 (2), applied in full or in
part, and descriptions of the solutions adopted to meet the essential
requirements of the Directive where the standards referred to in Article
5havenotbeenapplied,
— resultsofdesigncalculationsmade,examinationscarriedout,etc.,— testreports.
4. Thenotifiedbodymust:
4.1. examinethetechnicaldocuments,verifythatthetypehasbeenmanufac-
tured in conformity with those documents and identify the elements
which have been designed in accordance with the relevant provisions
of the standards referred to in Article 5 (2) as well as the components
which have been designed without applying the relevant provisions of
thosestandards;
4.2. perform or have performed the appropriate examinations and necessary
tests to check whether, where the standards referred to in Article 5 (2)
have not been applied, the solutions adopted by the manufacturer meet
theessentialrequirementsoftheDirective;
4.3. perform or have performed the appropriate examinations and necessary
teststocheckwhether,wherethemanufacturerhaschosentoapplythe
relevantstandards,thesehaveactuallybeenapplied;
4.4. agreewiththeapplicantthelocationwheretheexaminationsandneces-
sarytestsaretobecarriedout.
5. Where the type meets the relevant provisions of this Directive, the notified
bodyissuesanEC type-examination certificate tothe applicant. The certifi-
catecontainsthenameandaddressofthemanufacturer,theconclusionofthe
examinationandnecessarydataforidentificationoftheapprovedtype.
Alistoftherelevantpartsofthetechnicaldocumentsisannexedtothecerti-
ficateandacopykeptbythenotifiedbody.
If the manufacturer or his authorized representative established in the
Community is refused a type certificate, the notified body must provide
detailedreasonsforsuchrefusal.
Provisionmustbemadeforanappealsprocedure.
6. The applicant informs the notified body that holds the technical documents
concerning the EC type-examination certificate of all modifications to the
approved appliance which must receive additional approval where such
changes may affect the conformity with the essential requirements or the1992L0042—EN—21.02.2004—002.001—11
▼B
prescribedconditionsforuseoftheproduct.Thisadditionalapprovalisgiven
intheformofanadditiontotheoriginalECtype-examinationcertificate.
7. Each notified body must communicate to the other notified bodies the rele-
vant information concerning the EC type-examination certificates and
additionsissuedandwithdrawn.
8. The other notified bodies may receive copies of the EC type-examination
certificates and/or their additions. The Annexes to the certificates must be
keptatthedisposaloftheothernotifiedbodies.
9. The manufacturer or his authorized representative established within the
Community must keep with the technical documents copies of EC type-
examination certificates and their additions for a period of at least 10 years
afterthelastdateofmanufactureoftheproductconcerned.
Where neither the manufacturer nor his authorized representative is estab-
lished within the Community, the obligation to keep the technical
documents available is the responsibility of the person who places the
productontheCommunitymarket.1992L0042—EN—21.02.2004—002.001—12
▼B
ANNEX IV
ModuleC:Conformitytotype
1. Thismoduledescribesthatpartoftheprocedurewherebythemanufacturer
or hisauthorized representative established within the Community ensures
anddeclaresthattheappliancesconcernedareinconformitywiththetype
asdescribedintheECtype-examinationcertificateandsatisfytherequire-
mentsofthisDirectivethatapplytothem. ►M1Themanufacturerorhis
authorized representative established withinthe Community shall affix the
CE marking to each appliance and draw up a written declaration of
conformity. ◄
2. The manufacturer must take all measures necessary to ensure that the
manufacturing process assures the conformity of the manufactured appli-
ances with the type as described in the EC type-examination certificate
andwiththeefficiencyrequirementsoftheDirective.
3. Themanufacturerorhisauthorizedrepresentativemustkeepacopyofthe
declarationofconformityforaperiodofatleast10yearsafterthelastdate
ofmanufactureoftheproductconcerned.
Where neither the manufacturer nor hisauthorized representative is estab-
lished within the Community, the obligation to keep the technical
documents available is the responsibility of the person who places the
productontheCommunitymarket.
4. A notified body chosen by the manufacturer must perform or have
performed examinations of the product at random intervals. A suitable
sampleofthefinishedproducts,takenonthespotbythenotifiedbody,is
examined andappropriate tests,definedintheapplicable standardorstan-
dardsreferredtoinArticle5(2)orequivalenttestsarecarriedouttocheck
the conformity of the product with the requirements of the corresponding
Directive. In the event of one or more samples of the products examined
notconforming,thenotifiedbodymusttaketheappropriatemeasures.
ModuleD:Productionqualityassurance
1. Thismoduledescribestheprocedure wherebythemanufacturer whosatis-
fies the obligations of section 2 ensures and declares that the appliances
concerned are in conformity with the type as described in the EC type-
examination certificate and satisfy the requirements of this Directive.
►M1Themanufacturerorhisauthorizedrepresentativeestablishedwithin
theCommunityshallaffixtheCEmarkingtoeachapplianceanddrawupa
written declaration ofconformity. TheCEmarking isaccompanied bythe
identification number of the notified body responsible for the checks
referredtoinsection4. ◄
2. Themanufacturermustoperateanapprovedqualitysystemforproduction,
final appliance inspection and testing as specified in section 3. He is
subjecttothechecksreferredtoinsection4.
3.Quality system
3.1. The manufacturer lodges an application for assessment of his quality
systemwithanotifiedbodyofhischoice,fortheappliancesconcerned.
Theapplicationmustinclude:
— allrelevantinformationfortheappliancecategoryenvisaged,
— thedocumentsconcerningthequalitysystem,— thetechnical documentspertainingtotheapprovedtypeandacopyof
theECtype-examinationcertificate.
3.2. The quality systemmustensureconformity ofappliances withthetype as
describedintheECtype-examinationcertificateandwiththerequirements
ofthisDirectivethatapplytothem.
Alltheelements,requirementsandprovisionsadoptedbythemanufacturer
must be documented in a systematic and orderly manner in the form of
writtenpolicies,proceduresandinstructions.Thequalitysystemdocuments
must permit a consistent interpretation of the quality programmes, plans,
manualsandqualityrecords.
Itmustcontaininparticularanadequatedescriptionof:
— the quality objectives and the organizational structure, responsibilities
andpowersofthemanagementwithregardtoappliancequality,
— the manufacturing, quality control and quality assurance techniques,
processesandsystematicactionsthatwillbeused,1992L0042—EN—21.02.2004—002.001—13
▼B
— the examinations and tests that will be carried out before, during and
after manufacture, and the frequency with which they will be carried
out,
— thequalityrecords,suchasinspectionreportsandtestdata,calibration
data,qualificationreportsofthepersonnelconcerned,etc.,
— the means of monitoring the achievement of the required appliance
qualityandtheeffectiveoperationofthequalitysystem.
3.3. The notified body must assess the quality system to determine whether it
satisfiestherequirementsreferredtoinsection3.2.Itmustpresumeconfor-
mity withthoserequirements inrespect ofquality systemsthatimplement
therelevantharmonizedstandard.Theauditingteammusthaveatleastone
memberwithexperienceofassessingtherelevantproducttechnology.The
assessment procedure includes an inspection visit to the manufacturer's
premises.
Thedecisionisnotifiedtothemanufacturer.Thenotificationmustcontain
the conclusions of the examination and the duly substantiated assessment
decision.
3.4. Themanufacturermustundertaketofulfiltheobligationsarisingoutofthe
quality systemas approved and m aintain it at an adequate and efficient
level.
The manufacturer or his authorized representative must keep the notified
body that has approved the quality systeminform ed of any proposed
changeinthequalitysystem.
The notified body must assess the changes proposed and decide whether
the altered quality systemwill still satisfy the requirem ents referred to in
3.2orwhetherreassessmentisrequired.
It must notify the manufacturer of its decision. The notification must
containtheconclusionsoftheexaminationandthesubstantiatedassessment
decision.
4.Monitoring under the responsibility of the notified body
4.1. The purpose of monitoring is to make sure that the manufacturer duly
fulfilstheobligationsarisingoutoftheapprovedqualitysystem.
4.2. The manufacturer must allow the notified body access for inspection
purposes to the manufacturing, inspection, testing and storage premises
andprovideitwithallnecessaryinformation,inparticular:
— thequalitysystemdocuments,
— thequalityrecords,suchasinspectionreportsandtestdata,calibration
data,qualificationreportsofthepersonnelconcerned,etc..
4.3. Thenotifiedbodymustperiodically carryoutauditstomakesurethatthe
manufacturer maintains and applies the quality system and provides an
auditreporttothemanufacturer.
4.4. Additionallythenotifiedbodymaypayunannouncedvisitstothemanufac-
turer.Duringsuchvisitsthenotifiedbodymaycarryouttestsorhavethem
carried out to verify that the quality systemis functioning correctly; if
necessary, the notified body must provide the manufacturer with a visit
reportand,ifatesthastakenplace,withatestreport.
5. Themanufacturermust,foraperiodofatleast10yearsafterthelastdate
ofmanufactureoftheproduct,keepatthedisposalofthenationalauthori-
ties:
— thedocumentreferredtointhesecondindentof3.1,
— theupdatingreferredtointhesecondparagraphof3.4,
— thedecisionsandreportsfromthenotifiedbodywhicharereferredtoin
thefinalparagraphof3.4,andin4.3and4.4.
6. Each notified body must give the other notified bodies the relevant infor-
mationconcerningthequalitysystemapprovalsissuedandwithdrawn.
ModuleE:Productqualityassurance
1. Thismoduledescribestheprocedure wherebythemanufacturer whosatis-
fies the obligations of section 2 ensures and declares that the boilers and
appliances are in conformity with the type as described in the EC type-
examination certificate. ►M1The manufacturer or his authorized repre-
sentative established within the Community shall affix the CE marking to
eachboilerandapplianceanddrawupawrittendeclarationofconformity.
TheCEmarkingmustbeaccompaniedbytheidentificationnumberofthe
notifiedbodyresponsibleforthechecksreferredtoinsection4. ◄1992L0042—EN—21.02.2004—002.001—14
▼B
2. Themanufacturermustoperateanapprovedqualitysystemforfinalboiler
andappliance inspection andtesting asspecified insection 3.Hemustbe
subjecttothechecksreferredtoinsection4.
3.Quality system
3.1. Themanufacturerlodgesanapplicationwithanotifiedbodyofthischoice
fortheassessmentofthequalitysystemforhisboilersandappliances.
Theapplicationmustinclude:
— allrelevantinformationfortheboilerorappliancecategoryenvisaged,
— thequalitysystem'sdocumentation,
— thetechnical documentspertainingtotheapprovedtypeandacopyof
theECtype-examinationcertificate.
3.2. Underthequalitysystem,eachboilerorapplianceisexaminedandappro-
priatetestsasdefinedintherelevantstandard(s)referredtoinArticle5or
equivalent tests are carried out in order to verify its conformity with the
relevant requirements ofthe Directive. Allthe elements, requirements and
provisions adopted by the manufacturer must be documented in a
systematic and orderly manner in the form of written policies, procedures
andinstructions.Thisqualitysystemdocumentationmustenablethequality
programmes, plans, manuals and records to be interpreted in a uniform
manner.
Itmustinparticularcontainanadequatedescriptionof:
— the quality objectives and the organizational structure, responsibilities
andpowersofthemanagementwithregardtoproductquality,
— theexaminationandteststhatwillbecarriedoutaftermanufacture,— themeansofmonitoringtheeffectiveoperationofthequalitysystem,— quality records, such as inspection reports and test data, calibration
data,qualificationreportsofthepersonnelconcerned,etc.
3.3. The notified body must assess the quality system to determine whether it
satisfies the requirements referred to in 3.2. It must presume conformity
with these requirements in respect of quality systems that implement the
relevantharmonizedstandard.
Theauditingteammusthaveatleastonememberwithexperienceofasses-
sing the relevant product technology. The assessment procedure must
includeaninspectionvisittothemanufacturer'spremises.
The manufacturer must be notified of the decision. The notification must
containtheconclusionsoftheexaminationandthesubstantiatedassessment
decision.
3.4. Themanufacturermustundertaketofulfiltheobligationsarisingoutofthe
quality systemas approved and m aintain it at an adequate and efficient
level.
The manufacturer or his authorized representative must keep the notified
body which has approved the quality systeminform ed of any proposed
changeinthequalitysystem.
The notified body must assess the changes proposed and decide whether
the altered quality systemwill still satisfy the requirem ents referred to in
3.2orwhetherareassessmentisrequired.
It must notify the manufacturer of its decision. The notification must
containtheconclusionsoftheexaminationandthesubstantiatedassessment
decision.
4.Monitoring under the responsibility of the notified body
4.1. The purpose of monitoring is to make sure that the manufacturer duly
fulfilstheobligationsarisingoutoftheapprovedqualitysystem.
4.2. The manufacturer must allow the notified body access for inspection
purposes to the inspection, testing and storage premises and provide it
withallnecessaryinformation,inparticular:
— thequalitysystemdocumentation,
— thetechnicaldocuments,
— thequalityrecords,suchasinspectionreportsandtestdata,calibration
data,qualificationreportsofthepersonnelconcerned,etc.
4.3. The notified body must periodically carry out audits to ensure that the
manufacturer maintains and applies the quality system and must provide
anauditreporttothemanufacturer.1992L0042—EN—21.02.2004—002.001—15
▼B
4.4. Additionally, the notified body may pay unannounced visits to the manu-
facturer. During such visits the notified body may carry out tests or have
themcarried out to verify that the quality systemis functioning correctly;
if necessary, the notified body must provide the manufacturer with a visit
reportand,ifatesthasbeencarriedout,withatestreport.
5. Themanufacturermust,foraperiodofatleast10yearsafterthelastdate
of manufacture of the boiler or appliance, keep at the disposal of the
nationalauthorities:
— thedocumentsreferredtointhethirdindentof3.1,
— thechangesreferredtointhesecondparagraphof3.4,
— thedecisionsandreportsfromthenotifiedbodywhicharereferredtoin
thefinalparagraphof3.4,andin4.3and4.4.
6. Each notified body must forward to the other notified bodies the relevant
informationconcerningthequalitysystemapprovalsissuedandwithdrawn.1992L0042—EN—21.02.2004—002.001—16
▼B
ANNEX V
Minimum criteria to be taken into account by Member States for the noti-
ficationofbodies
1. Thebody,itsdirectorandthestaffresponsibleforcarryingouttheverifica-
tion tests may not be the designer, manufacturer, supplier or installer of
appliances which they inspect, nor the authorized representative of any of
thoseparties.Theymaynotbecomeeitherinvolveddirectlyorasauthorized
representativesinthedesign,construction,marketingormaintenanceofsuchboilersandappliances.Thisdoesnotprecludethepossibilityofexchangesof
technicalinformationbetweenthemanufacturerandthebody.
2. The body and its staff must carry out the verification tests with the highest
degree of professional integrity and technical competence and must be free
fromallpressuresandinducements,particularlyfinancial,whichmightinflu-
encetheirjudgment oftheresultsoftheinspection, especially frompersons
orgroupsofpersonswithaninterestintheresultofverifications.
3. Thebodymusthaveatitsdisposalthenecessarystaffandpossesstheneces-
sary facilities to enable it to performproperly the adm inistrative and
technical tasks connected with verification; it must also have access to the
equipmentrequiredforspecialverification.
4. Thestaffresponsibleforinspectionmusthave:
— soundtechnicalandprofessionaltraining,
— satisfactoryknowledgeoftherequirementsoftheteststheycarryoutand
adequateexperienceofsuchtests,
— the ability to draw up the certificates, records and reports required to
authenticatetheperformanceofthetests.
5. The impartiality of inspection staff must be guaranteed. Their remuneration
mustnotdependonthenumberoftestscarriedoutorontheresultsofsuch
tests.
6. The bodymusttake outliability insurance unlessits liability isassumed by
the State in accordance with national law, or the Member State itself is
directlyresponsibleforthetests.
7. Thestaffofthebodymustbeboundtoobserveprofessionalsecrecy(except
vis-à-visthe competent administrative authorities of the State in which its
activities are carried out) under this Directive or any provision of national
lawgivingeffecttoit.1992L0042—EN—21.02.2004—002.001—17