1992L0042 — EN — 02.08.1993 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCIL DIRECTIVE 92/42/EEC
of 21 May 1992
on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels
(OJ L 167, 22.6.1992, p. 17)
Amended by:
Official Journal
No page date
►M1 Council Directive 93/68/EEC of 22 July 1993 L 220 1 30.8.1993
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▼B
COUNCIL DIRECTIVE 92/42/EEC
of 21 May 1992
on efficiency requirements for new hot-water boilers fired with
liquid or gaseous fuels
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European EconomicCommunity, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (
1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas Decision 91/565/EEC (4) provides for the promotion of energy
efficiency in the Community under the SAVE programme;
Whereas it is important to promote measures aimed at the progressive
establishement of the internal market in the period up to 31 December1992; whereas the internal market encompasses an area without internalfrontiers, in which the free circulation of goods, persons, services andcapital is assured;
Whereas the Council resolution of 15 January 1985 on the improvement
of energy-saving programmes in the Member States (
5) invites Member
States to pursue and where necessary increase their efforts to promotethe more rational use of energy by the further development of integratedenergy-saving policies;
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
improving the efficiency of final energy demand by at least 20 %;
Whereas Article 130r of the Treaty provides that action by the
Community relating to the environment shall have the objective ofensuring a prudent and rational utilization of natural resources;
Whereas it is appropriate to take as a base a high level of protection in
proposals for the approximation of the provisions laid down by law,regulation or administrative action in Member States and concerninghealth, safety, environmental protection and consumer protection;
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
stabilized throughout the Community at their 1990 level;
Whereas the importance of the domestic and tertiary sector, which
absorbs a major proportion of the final consumption of energy in theCommunity, is considerable;
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 is in the consumer’s interest; whereas
energy saving will be reflected in fewer imports of hydrocarbons;whereas reduction in the Community’s energy dependence will have apositive impact on its trade balance;
(1) OJ No C 292, 22. 11. 1990, p. 8.
(2) OJ No C 129, 20. 5. 1991, p. 97 andOJ No C 94, 13. 4. 1992.
(3) OJ No C 102, 18. 4. 1991, p. 46.
(4) OJ No L 307, 8. 11. 1991, p. 34.
(5) OJ No C 20, 22. 1. 1985, p. 1.
(6) OJ No C 241, 25. 9. 1986, p. 1.
(7) OJ No C 183, 20. 7. 1989, p. 4.
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Whereas Council Directive 78/170/EEC of 13 February 1978 on the
performance of heat generators for space heating and the production ofhot water in new or existing non-industrial buildings and on the insula-tion of heat and domestic hot-water distribution in new non-industrialbuilings (
1), has given rise to the establishment of substantially different
efficiency levels between one Member State and another;
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 economies ofscale; whereas the absence of a measure laying down energy require-ments at a sufficiently high level may result, with the completion of theinternal market, in a significant drop in the efficiency levels of heatinginstallations through the spread on the market of low-efficiency boilers;
Whereas local climatic conditions and the energy and occupancy char-
acteristics of buildings differ greatly within the Community; whereasMember States must take this diversity into account when determiningthe conditions for putting boilers into service in implementation of thisDirecitve; 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 thisDirective should continue to authorize, within specific limits, theplacing on their markets and the putting into service of such boilers;whereas these arrangements should be subject to particular surveillanceby the Commission;
Whereas this Directive, which is aimed at eliminating technical barriers
with regard to boiler efficiency, must follow the new approach estab-lished by the Council resolution of 7 May 1985 (
2) which specifically
lays down that legislative harmonization is limited to the adoption, bymeans of directives based on Article 100 of the EEC Treaty, of theessential requirements with which products put on the market mustconform and that ‘these essential requirements shall be wordedprecisely enough in order to create legally binding obligations whichcan be enforced and to enable the certification bodies to certify productsas being in conformity, having regard to those requirements in theabsence of standards';
Having regard to Directive 83/189/EEC (
3) laying down a procedure for
the provision of information in the field of technical standards andregulations;
Having regard to Decision 90/683/EEC (
4) concerning the modules for
the various phases of the conformity assessment procedures which areintended to be used in the technical harmonization directives;
Whereas boilers complying with the efficiency requirements should
bear the CE mark and, where appropriate, signs in order to enable themto move freely and to be put into service in accordance with theirintended purpose within the Community;
Having regard to Directive 89/106/EEC (
5) on the approximation of
laws, regulations and administrative provisions of the Member Statesrelating to construction products;
Whereas efficiency requirements to encourage the rational use of energy
as laid down in Council Directive 90/396/EEC of 29 June 1990 on theapproximation of the laws of the Member States relating to appliancesburning gaseous fuels (
6) should be established for the gas boilers
referred to in this Directive,
(1) OJ No L 52, 23. 2. 1978, p. 32. Directive amended by Directive 82/
885/EEC (OJ No L 378, 31. 12. 1982, p. 19).
(2) OJ No C 136, 4. 6. 1985, p. 1.
(3) OJ No L 109, 26. 4. 1983, p. 8; Directive last amended by Decision
90/230/EEC (OJ No L 128, 18. 5. 1990, p. 15).
(4) OJ No L 380, 31. 12. 1990, p. 13.
(5) OJ No L 40, 11. 2. 1989, p. 12.
(6) OJ No L 196, 26. 7. 1990, p. 15.
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HAS ADOPTED THIS DIRECTIVE:
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 and nomore than 400 kW, hereinafter called ‘boilers'.
Article 2
For the purposes of this Directive:
—boiler: the combined boiler body-burner unit, designed to transmit
to water the heat released from burning,
—appliance:
— the boiler body designed to have a burner fitted,— the burner designed to be fitted to a boiler body,
—effective rated output (expressed in kW): the maximum calorific
output laid down and guaranteed by the manufacturer as beingdeliverable during continuous operation while complying with theuseful efficiency indicated by the manufacturer,
—useful efficiency (expressed in %): the ratio between the heat output
transmitted to the boiler water and the product of the net calorificvalue at constant fuel pressure and the consumption expressed as aquantity of fuel per unit time,
—part load (expressed in %): the ratio between the effective output of
a boiler operating intermittently or at an output lower than theeffective rated output and the same effective rated output;
—average temperature of the boiler water: the average of the water
temperatures at the entry and exit of the boiler,
—standard boiler: a boiler for which the average water temperature
can be restricted by design,
—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/gasfire combination,
—low-temperature boiler: a boiler which can work continuously with
a water supply temperature of 35 to 40 °C, possibly producing
condensation in certain circumstances, including condensing boilersusing liquid fuel,
—gas condensing boiler: a boiler designed to condense permanently a
large part of the water vapour contained in the combustion gases,
—boiler to be installed in the living space: a boiler with an effective
rated output of less than 37 kW, designed to provide heat to the partof the living space in which it is installed by means of the emissionof heatfrom t he casing having an open expansion chamber,supplying hot water using gravity circulation; such boilers shall bearon their casings the explicit indication that they must be installed inliving space.
Article 3
1. The following shall be excluded from this Directive:
— hot-water boilers capable of being fired by different fuels including
solid fuels,
— equipment for the instantaneous preparation of hot water,— boilers designed to be fired by fuels the properties of which differ
appreciably from the properties of the liquid and gaseous fuelscommonly marketed (industrial waste gas, biogas, etc),
— cookers and appliances designed mainly to heat the premises in
which they are installed and, as a subsidiary function, to supply hotwater for central heating and sanitary hot water,
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— appliances with rated outputs of less than 6 kW using gravity
circulation and designed solely for the production of stored sanitaryhotwat er,
— boilers manufactured on a one-off basis.
2. In the case of boilers with a dual function, that of heating premises
and also providing sanitary hot water, the efficiency requirementsreferred to in Article 5 (1) concern the heating function only.
Article 4
▼
M1
1. Member States may not prohibit, restrict or impede the placing onthe market or entry into service within their territories of appliances andboilers which comply with the provisions of this Directive and whichbear the CE marking provided for in Article 7 attesting to theconformity to all the provisions of this Directive, including theconformity assessment procedures laid down in Articles 7 and 8, save asotherwise laid down in the Treaty or other Directives or Communityprovisions.
▼
B
2. Member States shall take all necessary measures to ensure thatboilers cannot be put into service unless they satisfy the efficiencyrequirements set out in Article 5 (1) and the conditions for entry intoservice which the Member States lay down on the basis of local climaticconditions and the energy and occupancy characteristics of the build-ings.
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 ofthe adoption of the present Directive, shall continue to authorize theirentry into service, provided that their efficiency both at rated output andat 30 % part load is not more than 4 % below the requirements laiddown in Article 5 (1) for standard boilers.
4. The effects of the provisions in paragraphs 2 and 3 shall be
constantly monitored by the Commission and analysed in the report tobe submitted under Article 10. To this end the Member States shallforward to the Commission any information it requires to submit to theCouncil the proposed amendments, provided for in that Article,designed to ensure at all events the energy efficiency and free move-ment of boilers in the Community.
▼
M1
5 (a) Where the boilers are subject to other Directives concerning other
aspects which also provide for the affixing of the CE marking,the latter shall indicate that the boilers in question are alsopresumed to conform to the provisions of those other Directives.
(b) However, where one or more of these Directives allow the manu-
facturer, during a transitional period, to choose which arrange-ments to apply, the CE marking shall indicate conformity to theprovisions only of those Directives applied by the manufacturer.In this case, particulars of the Directives applied, as published intheOfficial Journal of the European Communities , mustbe given
in the documents, notices or instructions required by the Direct-ives and accompanying the boilers.
▼
B
Article 5
1. Boilers must comply with the following useful efficiency require-
ments:
— at rated output, i.e. operating at rated output Pn expressed in kW, at
an average boiler-water temperature of 70 °C , and
— a partload, i.e. operat ing at30 % partload, atan average boiler-
water temperature which varies according to the type of the boiler.
The useful efficiency requirements to be complied with are set out in
the following table:
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Type of boilerRange of power
outputEfficiency at rated output Efficiency atpart load
kWAverage boiler-
water tempera-
ture
(in°C)Efficiency
requirement
expressed
(in %)Average boiler-
water tempera-
ture
(in°C)Efficiency
requirement
expressed
(in %)
Standard
boilers4to4 0 0 70 /greaterdblequal8 4+2
logPn/greaterdblequal50 /greaterdblequal8 0+3
logPn
Low-tempera-
ture boilers (*)4to4 0 0 70 /greaterdblequal87,5 + 1,5
logPn40 /greaterdblequal87,5 + 1,5
logPn
Gascondensingboilers 4to4 0 0 70 /greaterdblequal9 1+1
logPn30 (**) /greaterdblequal9 7+1
logPn
(*) Including condensing boilers using liquid fuels
(**) Temperature of boiler water-supply
2. The harmonized standards relating to the requirements of thisDirective drawn up under mandate from the Commission in accordancewith Directive 83/189/EEC and 88/182/EEC (
1) shall determine, inter
alia, the verification methods valid for production and measurements.
Appropriate tolerances must be incorporated in the efficiency levels.
Article 6
1. Under the procedures laid down in Article 7, Member States may
decide to apply a specific system of labels enabling the energyperformance of boilers to be clearly ascertained. This system shall applyto boilers the efficiency of which is superior to the requirements forstandard boilers set out in Article 5 (1).
If its efficiency at rated output and its efficiency at part load are equal
to or greater than the relevant values for standard boilers, a boiler shallbe awarded an ‘ ⋆' as setoutin Annex I, sect ion 2.
If its efficiency at rated output and its efficiency at part load are three or
more points higher than the relevant values for standard boilers a boilershall be awarded ‘ ⋆⋆'.
Every extra step of efficiency of three points at rated output and at part
load will allow the attribution of an extra ‘ ⋆' as setoutin Annex II.
2. Member States may not authorize any other label likely to be
confused with those referred to in paragraph 1.
Article 7
1. Member States shall deem that boilers which comply with the
harmonized standards, the reference numbers of which have beenpublished in the Official Journal of the European Communities and for
which the Member States have published the reference numbers of thenational standards transposing those harmonized standards, to be inconformity with the essential efficiency requirements stipulated inArticle 5 (1). Such boilers must bear the ►
M1CE marking ◄referred
to in Annex I, section 1, and be accompanied by the EC declaration ofconformity.
2. The conformity of series-produced boilers shall be certified by:
— examination of the efficiency of a boiler type in accordance with
module B as described in Annex III,
— a declaration of conformity to the approved type in accordance with
module C, D or E as described in Annex IV.
(1) OJ No L 81, 26. 3. 1988, p. 75.
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For boilers burning gaseous fuels, the procedures for assessing the
conformity of their efficiency shall be those used to assess conformityto the safety requirements laid down in Directive 90/396/EEC on theapproximation of the laws of the Member States relating to appliancesburning gaseous fuels.
3. When appliances marketed separately are placed on the market,
they must bear the ►
M1CE marking ◄and be accompanied by the
EC declaration of conformity, which defines the parameters enablingthem after assembly to achieve the useful efficiency levels laid down inArticle 5 (1).
▼
M1
4. The CE mark of conformity to the requirements of this Directiveand to the other provisions concerning the granting of the CE marking,and also the inscriptions specified in Annex I, shall be affixed on boilersin a visible, easily legible and indelible manner. The affixing on suchproducts of any markings likely to deceive third parties as to themeaning and form of the CE marking shall be prohibited. Any othermarking may be affixed to the boilers and appliances provided that thevisibility 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 agentestablished within the Community shall be obliged to make theboiler comply as regards the provisions concerning the CEmarking and to end the infringement under conditions imposedby the Member State;
(b) where non-compliance continues, the Member State must take all
appropriate measures to restrict or prohibit the placing on themarket of the product in question or to ensure that it is with-drawn from the market, and shall inform the Commission andthe other Member States accordingly.
▼
B
Article 8
▼M1
1. Member States shall inform the Commission and the otherMember States of the bodies which they have appointed to carry out theprocedures referred to in Article 7, together with specific tasks whichthese bodies have been appointed to carry out and the identificationnumbers assigned to them beforehand by the Commission.
The Commission shall publish in the Official Journal of the European
Communities a list of the notified bodies with their identication numbers
and the tasks for which they have been notified. The Commission shallensure that this list is kept up to date.
▼
B
2. Member States shall implement the minimum criteria laid down inAnnex V for the appointment of such bodies. Bodies which satisfy thecriteria laid down in the corresponding harmonized standards shall bedeemed to comply with the criteria laid down in that Annex.
3. A Member State which has notified a particular body must with-
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 andshall withdraw the notification.
Article 9
1. By 1 January 1993, Member States shall adopt and publish the
provisions necessary to comply with this Directive. They shall forthwithinform the Commission thereof.
They shall apply those provisions from 1 January 1994.When Member States adopt those provisions, they shall contain a refer-
ence to this Directive or shall be accompanied by such a reference on
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the occasion of their official publication. The methods of making such areference shall be laid down by the Member States.
2. Until 31 December 1997, Member States shall permit the placing
on the market and putting into service of appliances complying with thenational rules and schemes in force within their territories on the date ofthe adoption of this Directive.
Article 10
Three years after the implementation of this Directive the Commission
shall submit a report to the European Parliament and to the Council onthe results achieved. That report shall be accompanied by proposals forany changes to be made to this Directive in the light of those results andof advances in technology.
Article 11
This Directive is addressed to the Member States.
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ANNEX I
CE CONFORMITY MARKING AND ADDITIONAL SPECIFIC MARK-
INGS
1.CE conformity marking
The CE conformity marking shall consist of the initials ‘CE' taking the
following form:
— If the CE marking is reduced or enlarged the proportions given in the
above graduated drawing must be respected.
— The various components of the CE marking must have substantially the
same vertical dimension, which may not be less than 5 mm.
2.Additional specific markings
— The last two digits of the year in which the EC marking was affixed.
— The energy performance label awarded under Article 6 of this Directive
consists of the following symbol:

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ANNEX II
AWARD OF ENERGY-PERFORMANCE LABELS
Efficiency requirements to be met both at nominal output and at part-load of
0,3 Pn
LabelEfficiency requirementat
nominal out putPn and atan
average boiler-water tempera-
ture of 70 °C%Efficiency requirementatpart -
load of 0,3 Pn and atan
average boiler-water tempera-
ture of/greaterdblequal50 °C%
/greaterdblequal84 + 2 log Pn /greaterdblequal80 + 3 log Pn
/greaterdblequal87 + 2 log Pn /greaterdblequal83 + 3 log Pn
/greaterdblequal90 + 2 log Pn /greaterdblequal86 + 3 log Pn
/greaterdblequal93 + 2 log Pn /greaterdblequal89 + 3 log Pn
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ANNEX III
Module B: EC type-examination
1. This module describes that part of the procedure by which a notified body
ascertains and attests that an example, representative of the production envis-aged, meets the relevant provisions of the Directive.
2. The application for EC type-examination is lodged by the manufacturer or his
authorized representative established within the Community with a notifiedbody of his choice.
The application must include:
— the name and address of the manufacturer and, if the application is lodged
by the authorized representative, the name and address in addition,
— a written declaration that the same application has not been lodged with
any other notified body,
— the technical documents, as described in section 3.
The applicantmustplace att he disposal of t he not ified body an example
representative of the production envisaged, hereinafter called ‘type'. Thenotified body may request further examples if needed for carrying out the testprogramme.
3. The technical documents must enable the conformity of the appliance with the
requirements of the Directive to be assessed. They must, as far as is relevantfor such assessment, cover the design, manufacture and operation of theappliance and contain as far as is relevant for assessment:
— a general type-description,— conceptual design and manufacturing drawings and diagrams of compo-
nents, sub-assemblies, circuits, etc.,
— descriptions and explanations necessary for the understanding of the draw-
ings and diagrams and the operation of the product,
— 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 require-ments of the Directive where the standards referred to in Article 5 havenotbeen applied,
— results of design calculations made, examinations carried out, etc.,— test reports.
4. The notified body must:
4.1. examine the technical documents, verify that the type has been manufac-
tured in conformity with those documents and identify the elementswhich have been designed in accordance with the relevant provisions ofthe standards referred to in Article 5 (2) as well as the componentswhich have been designed without applying the relevant provisions ofthose standards;
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 meetthe essential requirements of the Directive;
4.3. perform or have performed the appropriate examinations and necessary
tests to check whether, where the manufacturer has chosen to apply therelevant standards, these have actually been applied;
4.4. agree with the applicant the location where the examinations and neces-
sary tests are to be carried out.
5. Where the type meets the relevant provisions of this Directive, the notified
body issues an EC type-examination certificate to the applicant. The certifi-cate contains the name and address of the manufacturer, the conclusion of theexamination and necessary data for identification of the approved type.
A list of the relevant parts of the technical documents is annexed to the
certificate and a copy kept by the notified body.
If the manufacturer or his authorized representative established in the
Community is refused a type certificate, the notified body must providedetailed reasons for such refusal.
Provision mustbe made for an appeals procedure.
6. The applicant informs the notified body that holds the technical documents
concerning the EC type-examination certificate of all modifications to theapproved appliance which mustreceive addit ional approval where suchchanges may affect the conformity with the essential requirements or the
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prescribed conditions for use of the product. This additional approval is given
in the form of an addition to the original EC type-examination certificate.
7. Each notified body must communicate to the other notified bodies the relevant
information concerning the EC type-examination certificates and additionsissued and withdrawn.
8. The other notified bodies may receive copies of the EC type-examination
certificates and/or their additions. The Annexes to the certificates must bekept at the disposal of the other notified bodies.
9. The manufacturer or his authorized representative established within the
Community must keep with the technical documents copies of EC type-exam-ination certificates and their additions for a period of at least 10 years after thelast date of manufacture of the product concerned.
Where neither the manufacturer nor his authorized representative is estab-
lished within the Community, the obligation to keep the technical documentsavailable is the responsibility of the person who places the product on theCommunity market.
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ANNEX IV
Module C: Conformity to type
1. This module describes that part of the procedure whereby the manufacturer
or his authorized representative established within the Community ensuresand declares that the appliances concerned are in conformity with the typeas described in the EC type-examination certificate and satisfy the require-ments of this Directive that apply to them. ►
M1The manufacturer or his
authorized representative established within the Community shall affix theCE marking to each appliance and draw up a written declaration ofconformity. ◄
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 andwith the efficiency requirements of the Directive.
3. The manufacturer or his authorized representative must keep a copy of the
declaration of conformity for a period of at least 10 years after the last dateof manufacture of the product concerned.
Where neither the manufacturer nor his authorized representative is estab-
lished within the Community, the obligation to keep the technical docu-ments available is the responsibility of the person who places the product onthe Community market.
4. A notified body chosen by the manufacturer must perform or have
performed examinations of the product at random intervals. A suitablesample of the finished products, taken on the spot by the notified body, isexamined and appropriate tests, defined in the applicable standard or stan-dards referred to in Article 5 (2) or equivalent tests are carried out to checkthe conformity of the product with the requirements of the correspondingDirective. In the event of one or more samples of the products examined notconforming, the notified body must take the appropriate measures.
Module D: Production quality assurance
1. This module describes the procedure whereby the manufacturer who satis-
fies the obligations of section 2 ensures and declares that the appliancesconcerned are in conformity with the type as described in the EC type-examination certificate and satisfy the requirements of this Directive.►
M1The manufacturer or his authorized representative established within
the Community shall affix the CE marking to each appliance and draw up awritten declaration of conformity. The CE marking is accompanied by theidentification number of the notified body responsible for the checksreferred to in section 4. ◄
2. The manufacturer must operate an approved quality system for production,
final appliance inspection and testing as specified in section 3. He is subjectto the checks referred to in section 4.
3.Quality system
3.1. The manufacturer lodges an application for assessment of his quality system
with a notified body of his choice, for the appliances concerned.
The application must include:
— all relevant information for the appliance category envisaged,— the documents concerning the quality system,— the technical documents pertaining to the approved type and a copy of
the EC type-examination certificate.
3.2. The quality system must ensure conformity of appliances with the type as
described in the EC type-examination certificate and with the requirementsof this Directive that apply to them.
All the elements, requirements and provisions adopted by the manufacturer
must be documented in a systematic and orderly manner in the form ofwritten policies, procedures and instructions. The quality system documentsmust permit a consistent interpretation of the quality programmes, plans,manuals and quality records.
It must contain in particular an adequate description of:
— the quality objectives and the organizational structure, responsibilities
and powers of the management with regard to appliance quality,
— the manufacturing, quality control and quality assurance techniques,
processes and systematic actions that will be used,
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— the examinations and tests that will be carried out before, during and
after manufacture, and the frequency with which they will be carriedout,
— the quality records, such as inspection reports and test data, calibration
data, qualification reports of the personnel concerned, etc.,
— the means of monitoring the achievement of the required appliance
quality and the effective operation of the quality system.
3.3. The notified body must assess the quality system to determine whether it
satisfies the requirements referred to in section 3.2. It must presumeconformity with those requirements in respect of quality systems that imple-ment the relevant harmonized standard. The auditing team must have atleast one member with experience of assessing the relevant product tech-nology. The assessment procedure includes an inspection visit to the manu-facturer’s premises.
The decision is notified to the manufacturer. The notification must contain
the conclusions of the examination and the duly substantiated assessmentdecision
3.4. The manufacturer must undertake to fulfil the obligations arising out of the
quality system as approved and maintain it at an adequate and efficientlevel.
The manufacturer or his authorized representative must keep the notified
body that has approved the quality system informed of any proposed changein the quality system.
The notified body must assess the changes proposed and decide whether the
altered quality system will still satisfy the requirements referred to in 3.2 orwhether reassessment is required.
It must notify the manufacturer of its decision. The notification must contain
the conclusions of the examination and the substantiated assessmentdecision.
4.Monitoring under the responsibility of the notified body
4.1. The purpose of monitoring is to make sure that the manufacturer duly fulfils
the obligations arising out of the approved quality system.
4.2. The manufacturer must allow the notified body access for inspection
purposes to the manufacturing, inspection, testing and storage premises andprovide it with all necessary information, in particular:
— the quality system documents,— the quality records, such as inspection reports and test data, calibration
data, qualification reports of the personnel concerned, etc..
4.3. The notified body must periodically carry out audits to make sure that the
manufacturer maintains and applies the quality system and provides an auditreport to the manufacturer.
4.4. Additionally the notified body may pay unannounced visits to the manufac-
turer. During such visits the notified body may carry out tests or have themcarried out to verify that the quality system is functioning correctly; ifnecessary, the notified body must provide the manufacturer with a visitreport and, if a test has taken place, with a test report.
5. The manufacturer must, for a period of at least 10 years after the last date of
manufacture of the product, keep at the disposal of the national authorities:
— the document referred to in the second indent of 3.1,— the updating referred to in the second paragraph of 3.4,— the decisions and reports from the notified body which are referred to in
the final paragraph of 3.4, and in 4.3 and 4.4.
6. Each notified body must give the other notified bodies the relevant informa-
tion concerning the quality system approvals issued and withdrawn.
Module E: Product quality assurance
1. This module describes the procedure whereby the manufacturer who satis-
fies the obligations of section 2 ensures and declares that the boilers andappliances are in conformity with the type as described in the EC type-examination certificate. ►
M1The manufacturer or his authorized repres-
entative established within the Community shall affix the CE marking toeach boiler and appliance and draw up a written declaration of conformity.The CE marking must be accompanied by the identification number of thenotified body responsible for the checks referred to in section 4. ◄
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2. The manufacturer must operate an approved quality system for final boiler
and appliance inspection and testing as specified in section 3. He must besubject to the checks referred to in section 4.
3.Quality system
3.1. The manufacturer lodges an application with a notified body of this choice
for the assessment of the quality system for his boilers and appliances.
The application must include:
— all relevant information for the boiler or appliance category envisaged,— the quality system’s documentation,— the technical documents pertaining to the approved type and a copy of
the EC type-examination certificate.
3.2. Under the quality system, each boiler or appliance is examined and appro-
priate tests as defined in the relevant standard(s) referred to in Article 5 orequivalent tests are carried out in order to verify its conformity with therelevant requirements of the Directive. All the elements, requirements andprovisions adopted by the manufacturer must be documented in a systematicand orderly manner in the form of written policies, procedures and instruc-tions. This quality system documentation must enable the qualityprogrammes, plans, manuals and records to be interpreted in a uniformmanner.
It must in particular contain an adequate description of:
— the quality objectives and the organizational structure, responsibilities
and powers of the management with regard to product quality,
— the examination and tests that will be carried out after manufacture,— the means of monitoring the effective operation of the quality system,— quality records, such as inspection reports and test data, calibration data,
qualification reports of the personnel concerned, 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 conformitywith these requirements in respect of quality systems that implement therelevantharmonized st andard.
The auditing team must have at least one member with experience of
assessing the relevant product technology. The assessment procedure mustinclude an inspection visit to the manufacturer’s premises.
The manufacturer must be notified of the decision. The notification must
contain the conclusions of the examination and the substantiated assessmentdecision.
3.4. The manufacturer must undertake to fulfil the obligations arising out of the
quality system as approved and maintain it at an adequate and efficientlevel.
The manufacturer or his authorized representative must keep the notified
body which has approved the quality system informed of any proposedchange in the quality system.
The notified body must assess the changes proposed and decide whether the
altered quality system will still satisfy the requirements referred to in 3.2 orwhether a reassessment is required.
It must notify the manufacturer of its decision. The notification must contain
the conclusions of the examination and the substantiated assessmentdecision.
4.Monitoring under the responsibility of the notified body
4.1. The purpose of monitoring is to make sure that the manufacturer duly fulfils
the obligations arising out of the approved quality system.
4.2. The manufacturer must allow the notified body access for inspection
purposes to the inspection, testing and storage premises and provide it withall necessary information, in particular:
— the quality system documentation,— the technical documents,— the quality records, such as inspection reports and test data, calibration
data, qualification reports of the personnel concerned, 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 anaudit report to the manufacturer.
4.4. Additionally, the notified body may pay unannounced visits to the manufac-
turer. During such visits the notified body may carry out tests or have themcarried out to verify that the quality system is functioning correctly; if
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necessary, the notified body must provide the manufacturer with a visit
report and, if a test has been carried out, with a test report.
5. The manufacturer must, for a period of at least 10 years after the last date of
manufacture of the boiler or appliance, keep at the disposal of the nationalauthorities:
— the documents referred to in the third indent of 3.1,— the changes referred to in the second paragraph of 3.4,— the decisions and reports from the notified body which are referred to in
the final paragraph of 3.4, and in 4.3 and 4.4.
6. Each notified body must forward to the other notified bodies the relevant
information concerning the quality system approvals issued and withdrawn.
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ANNEX V
Minimum criteria to be taken into account by Member States for the
notification of bodies
1. The body, its director and the staff responsible for carrying out the verifica-
tion tests may not be the designer, manufacturer, supplier or installer ofappliances which they inspect, nor the authorized representative of any ofthose parties. They may not become either involved directly or as authorizedrepresentatives in the design, construction, marketing or maintenance of suchboilers and appliances. This does not preclude the possibility of exchanges oftechnical information between the manufacturer and the body.
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 freefrom all pressures and inducements, particularly financial, which might influ-ence their judgment of the results of the inspection, especially from persons orgroups of persons with an interest in the result of verifications.
3. The body must have at its disposal the necessary staff and possess the
necessary facilities to enable it to perform properly the administrative andtechnical tasks connected with verification; it must also have access to theequipmentrequired for special verificat ion.
4. The staff responsible for inspection must have:
— sound technical and professional training,— satisfactory knowledge of the requirements of the tests they carry out and
adequate experience of such tests,
— the ability to draw up the certificates, records and reports required to
authenticate the performance of the tests.
5. The impartiality of inspection staff must be guaranteed. Their remuneration
must not depend on the number of tests carried out or on the results of suchtests.
6. The body must take out liability insurance unless its liability is assumed by
the State in accordance with national law, or the Member State itself isdirectly responsible for the tests.
7. The staff of the body must be bound to observe professional secrecy (except
vis-à-vis the competent administrative authorities of the State in which its
activities are carried out) under this Directive or any provision of national lawgiving effect to it.