COUNCIL DIRECTIVE of
29 June 1990 on the approximation of the laws of the Member States relating
to appliances burning gaseous fuels (90/396/EEC)
THE COUNCIL OF THE
EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community,
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 Member States are responsible for ensuring the health and safety
on their territory of their people and, where appropriate, of domestic animals
and goods in relation to the hazards arising out of the use of appliances
burning gaseous fuels;
Whereas, in certain Member States, mandatory provisions define in particular
the safety level required of appliances burning gaseous fuels by specifying
design, operating characteristics and inspection procedures; whereas these
mandatory provisions do not necessarily lead to different safety levels from
one Member State to another but do, by their disparity, hinder trade within
the Community; Whereas different conditions as regards types of gas and supply
pressures are in force in the Member States; whereas these conditions are
not harmonized because each Member State's energy supply and distribution
situation is peculiar to it;
Whereas paragraphs 65 and 68 of the White Paper on the completion of the internal
market, approved by the European Council in June 1985, provide for a new approach
to legislative harmonization; Whereas Community law provides - by way of derogation
from one of the fundamental rules of the Community, namely the free movement
of goods - that obstacles to movement within the Community resulting from
disparities in national legislation relating to the marketing of products
must be accepted in so far as such obstacles can be recognized as being necessary
to satisfy mandatory requirements; whereas, therefore, the harmonization of
legislation in the present case must be limited to the provisions necessary
to satisfy both the mandatory and essential requirements regarding safety,
health and energy conservation in relation to gas appliances; whereas these
requirements must replace the national provisions in this matter because they
are essential requirements;
Whereas the maintenance or improvement of the level of safety attained in
Member States constitutes one of the essential aims of this Directive and
of safety as defined by the essential requirements;
Whereas the essential safety and health requirements must be observed in order
to ensure that appliances burning gaseous fuels are safe; whereas energy conservation
is considered essential; whereas these requirements must be applied with discernment
to take account of the state of the art at the time of construction;
Whereas this Directive therefore contains only essential requirements; whereas,
to facilitate proof of conformity with the essential requirements, it is necessary
to have harmonized standards at European level in particular as to the construction,
operation and installation of appliances burning gaseous fuels so that products
complying with them may be assumed to conform to the essential requirements;
whereas these standards, harmonized at European level, are drawn up by private
bodies and must remain non-mandatory texts; whereas for that purpose the European
Committee for Standardization (CEN) and the European Committee for Electrotechnical
Standardization (Cenelec) are recognized as the competent bodies for the adoption
of harmonized standards in accordance with the general guidelines for cooperation
between the Commission and those two bodies signed on 13 November 1984; whereas,
for the purposes of this Directive, a harmonized standard is a technical specification
(European standard or harmonization document) adopted by one or both of those
bodies upon a remit from the Commission in accordance with Council Directive
83/189/EEC of 28 March 1983 laying down a procedure for the provision of information
in the field of technical standards and regulations (4), as last amended by
Directive 88/182/EEC (5), and the abovementioned general guidelines;
Whereas, pending the adoption of harmonized standards within the meaning of
this Directive, conformity with the essential requirements and the free movement
of appliances burning gaseous fuels should be facilitated by the acceptance,
at Community level, of products conforming to the national standards whose
conformity with the essential requirements has been confirmed by a Community
checking procedure;
Whereas a check on compliance with the relevant technical requirements is
necessary in order to provide effective protection for users and third parties;
whereas the existing certification procedures differ from one Member State
to another; whereas, in order to avoid multiple inspections, which are in
effect barriers to the free movement of appliances burning gaseous fuels,
arrangements should be made for the mutual recognition of certification procedures
by the Member States; whereas, in order to facilitate mutual recognition of
certification procedures, harmonized Community procedures should be set up
and the criteria for appointing the bodies responsible for carrying out these
procedures should be harmonized;
Whereas the Member States' responsibility on their territory for safety, health
and energy conservation covered by the essential requirements must be recognized
in a safeguard clause providing for an adequate Community procedure;
Whereas the addressees of any decision taken under this Directive must be
informed of the reasons for such a decision and the legal remedies available
to them;
Whereas the Council adopted, on 17 September 1984, a framework Directive on
gas appliances (84/530/EEC) (6), as last amended by Directive 86/312/EEC (7),
and a separate Directive on gas water heaters (84/531/EEC) (8), as last amended
by Directive 88/665/EEC (9); whereas those Directives cover the same area
as this Directive and should therefore be repealed;
Whereas the measures aimed at the gradual establishment of the internal market
must be adopted by 31 December 1992; whereas the internal market consists
of an area without internal frontiers in which the free movement of goods,
persons, services and capital is ensured, HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
Scope, placing on the market and free movement
Article 1
1. This Directive shall apply to: - appliances burning gaseous fuels used
for cooking, heating, hot water production, refrigeration, lighting or washing
and having, where applicable, a normal water temperature not exceeding 105
gC, hereinafter referred to as 'appliances'. Forced draught burners and heating
bodies to be equipped with such burners will also be considered as appliances,
- safety devices, controlling devices or regulating devices and sub-assemblies,
other than forced draught burners and heating bodies to be equipped with such
burners separately marketed for trade use and designed to be incorporated
into an appliance burning gaseous fuel or assembled to constitute such an
appliance, hereinafter referred to as 'fittings'.
2. Appliances specifically designed for use in industrial processes carried
out on industrial premises are excluded from the scope defined in paragraph
1.
3. For the purposes of this Directive, 'gaseous fuel' means any fuel which
is in a gaseous state at a temperature of 15 gC under a pressure of 1 bar.
4. For the purposes of this Directive, an appliance is said to be 'normally
used' when it is: - correctly installed and regularly serviced in accordance
with the manufacturer's instructions, - used with a normal variation in the
gas quality and a normal fluctuation in the supply pressure, and - used in
accordance with its intended purpose or in a way which can be reasonably foreseen.
Article 2
1. Member States shall take all necessary steps to ensure that the appliances
referred to in Article 1 may be placed on the market and put into service
only if, when normally used, they do not compromise the safety of persons,
domestic animals and property.
2. Member States shall communicate the types of gas and corresponding supply
pressures used on their territory to the other Member States and the Commission
before 1 January 1991. They shall also communicate all changes in good time.
The Commission shall ensure that this information is published in the Official
Journal of the European Communities.
Article 3
Appliances and fittings as referred to in Article 1 shall satisfy the essential
requirements applicable to them set out in Annex I.
Article 4
1. Member States may not prohibit, restrict or impede the placing on the market
and the putting into service of appliances which satisfy the essential requirements
of this Directive.
2. Member States may not prohibit, restrict or impede the placing on the market
of fittings as referred to in Article 1 accompanied by a certificate as referred
to in Article 8 (4).
Article 5
1. Member States shall presume compliance with the essential requirements
referred to in Article 3 of appliances and fittings when they conform to:
(a) the national standards applicable to them implementing the harmonized
standards whose reference numbers have been published in the Official Journal
of the European Communities. Member States shall publish the reference numbers
of these national standards;
(b) the national standards applicable to them referred to in paragraph 2 in
so far as, in the areas covered by such standards, no harmonized standards
exist.
2. Member States shall communicate to the Commission the texts of their national
standards as referred to in paragraph 1 (b) which they regard as complying
with the essential requirements referred to in Article 3. The Commission shall
forward these national standards to the other Member States. In accordance
with the procedure provided for in Article 6 (2), it shall notify the Member
States of those national standards which are presumed to conform with the
essential requirements referred to in Article 3.
Article 6
1. Where a Member State or the Commission considers that the standards referred
to in Article 5 (1) do not entirely meet the essential requirements referred
to in Article 3, the Commission or the Member State concerned shall bring
the matter before the standing committee set up under Directive 83/189/EEC,
hereinafter referred to as 'the committee', giving the reasons therefore.
The committee shall deliver an opinion without delay. In the light of the
committee's opinion, the Commission shall inform the Member States whether
or not it is necessary to withdraw those standards from the publications referred
to in Article 5 (1).
2. After receipt of the communication referred to in Article 5 (2), the Commission
shall consult the committee. Upon receipt of the latter's opinion, the Commission
shall, within one month, inform the Member States whether or not the national
standard(s) in question are to enjoy the presumption of conformity; if they
are, the Member States shall publish the reference numbers of those standards.
The Commission shall also publish them in the Official Journal of the European
Communities.
Article 7
1. Where a Member State finds that normally used appliances bearing the EC
mark might compromise the safety of persons, domestic animals or property,
it shall take all appropriate measures to withdraw those appliances from the
market and prohibit or restrict their being placed on the market. The Member
State concerned shall immediately inform the Commission of any such measure,
indicating the reasons for its decision and, in particular, whether non-compliance
is due to:
(a) failure to meet the essential requirements referred to in Article 3, where
the appliance does not correspond to the standards referred to in Article
5 (1);
(b) incorrect application of the standards referred to in Article 5 (1);
(c) shortcomings in the standards referred to in Article 5 (1) themselves.
2. The Commission shall enter into consultation with the parties concerned
as soon as possible. Where, after such consultation, the Commission finds
that any measure as referred to in paragraph 1 is justified, it shall immediately
so inform the Member State that took the measure and the other Member States.
Where the decision referred to in paragraph 1 is attributed to shortcomings
in the standards, the Commission, after consulting the parties concerned,
shall bring the matter before the committee within two months if the Member
State which has taken the measures intends to maintain them, and shall initiate
the procedures referred to in Article 6.
3. Where an appliance which does not comply bears the EC mark, the competent
Member State shall take appropriate action against whomsoever has affixed
the mark and shall inform the Commission and the other Member States thereof.
4. The Commission shall ensure that the Member States are kept informed of
the progress and outcome of the procedures.
CHAPTER II
Means of certification of conformity
Article 8
1. The means of certification of conformity of series-manufactured appliances
shall be:
(a) the EC type-examination as referred to in section 1 of Annex II, and
(b) prior to their being placed on the market, at the choice of the manufacturer:
- the EC declaration of conformity to type referred to in section 2 of Annex
II, or - the EC declaration of conformity to type (guarantee of production
quality) referred to in section 3 of Annex II, or - the EC declaration of
conformity to type (guarantee of product quality) referred to in section 4
of Annex II, or - EC verification as referred to in section 5 of Annex II.
2. In the case of production of an appliance as a single unit or in small
quantities, EC verification by single unit, as referred to in section 6 of
Annex II, may be chosen by the manufacturer.
3. After completion of the procedures referred to in paragraphs 1 (b) and
2, the EC mark of conformity shall be affixed to conforming appliances in
accordance with Article 10.
4. The procedures referred to in paragraph 1 shall be applied in respect of
fittings as referred to in Article 1 with the exception of the affixing of
the EC mark of conformity and, where appropriate, the drawing-up of the declaration
of conformity. A certificate shall be issued declaring the conformity of the
fittings with the provisions of this Directive which apply to them and stating
their characteristics and how they must be incorporated into an appliance
or assembled to assist compliance with the essential requirements applicable
to finished appliances. The certificate shall be supplied with the fitting.
5. Where the appliances are also subject to other Community Directives: -
their compliance with the essential requirements of this Directive shall be
verified in accordance with the procedures laid down in paragraphs 1 and 2,
and - it shall be ensured that they also comply with the essential requirements
of the other Directives in accordance with the procedures laid down in those
Directives. The affixing of the EC mark as referred to in paragraph 3 shall
certify that the provisions of all the applicable Directives have been complied
with.
6. Records and correspondence relating to the means of certification of conformity
shall be drawn up in the official language(s) of the Member State where the
body responsible for carrying out these procedures is established or in a
language accepted by it.
Article 9
1. Each Member State shall notify the Commission and the other Member States
of the bodies, hereinafter called the 'notified bodies', responsible for carrying
out the procedures referred to in Article 8. The Commission shall publish
for information purposes in the Official Journal of the European Communities
a list of the notified bodies with their identification symbols and shall
ensure that the list is kept up to date.
2. Member States shall apply the criteria set out in Annex V for assessing
the bodies to be notified. Bodies which satisfy the assessment criteria laid
down in the applicable harmonized standards shall be presumed to satisfy the
criteria set out in that Annex.
3. A Member State which has notified a body must withdraw approval if it finds
that the body no longer meets the criteria referred to in paragraph 2. It
shall immediately inform the Commission and the other Member States accordingly.
CHAPTER III
EC mark of conformity
Article 10
1. The EC mark of conformity and the inscriptions set out in Annex III shall
be affixed in a visible, easily legible and indelible form to the appliance
or to a data plate attached to it. The data plate shall be so designed that
it cannot be re-used.
2. The affixing to appliances of marks which are likely to be confused with
the EC mark shall be prohibited.
Article 11
Where it is established that the EC mark has been wrongly
Where it is established that the EC mark has been wrongly affixed to appliances
or that certification for fittings has been wrongly attributed because: -
the appliances or the fittings do not conform to the appliance or fitting
as referred to in the EC type-examination certificate, - the appliances or
the fittings conform to the appliance or fitting as referred to in the EC
type-examination certificate but do not meet the essential requirements applicable
to them, - the manufacturer has failed to fulfil his obligations as specified
in Annex II, the notified body shall withdraw the right to affix the EC mark
or to issue the certificate and shall so inform the other notified bodies
and report to the Member State concerned.
CHAPTER IV
Final provisions
Article 12
Any decision taken pursuant to this Directive which includes restriction on
the placing on the market and/or putting into service of an appliance shall
state the precise grounds on which it is based. It shall be notified without
delay to the party concerned, who shall at the same time be informed of the
legal remedies available to him under the laws in force in the Member State
in question and of the time limits to which such remedies are subject.
Article 13
Directives 84/530/EEC and 84/531/EEC are hereby repealed.
Article 14
1. Before 1 July 1991, Member States shall adopt and publish the laws, regulations
and administrative provisions necessary to comply with this Directive. They
shall inform the Commission thereof. They shall apply such provisions from
1 January 1992.
2. However, in derogation from Article 2, Member States may, during the period
up to 31 December 1995 and without prejudice to Articles 30 to 36 of the Treaty,
permit the placing on the market and/or the putting into service of appliances
and fittings which comply with the regulations in force in the Member States
before 1 January 1992.
3. Member States shall communicate to the Commission the texts of the provisions
of national law which they adopt in the field covered by this Directive.
Article 15
This Directive is addressed to the Member States.
ANNEX I
ESSENTIAL REQUIREMENTS
Preliminary remark The obligations resulting from the essential requirements
for appliances in this Annex also apply to fittings where the corresponding
risk exists.
1. GENERAL CONDITIONS
1.1. Appliances must be so designed and built as to operate safely and present
no danger to persons, domestic animals or property when normally used as defined
in Article 1 (4) of this Directive.
1.2. When placed on the market, all appliances must: - be accompanied by technical
instructions intended for the installer, - be accompanied by instructions
for use and servicing, intended for the user, - bear appropriate warning notices,
which must also appear on the packaging. The instructions and warning notices
must be in the official language or languages of the Member States of destination.
1.2.1. The technical instructions intended for the installer must contain
all the instructions for installation, adjustment and servicing required to
ensure that those operations are correctly performed and that the appliance
may be used safely. In particular, the instructions must specify:
- the type of gas used,
- the gas supply pressure used,
- the flow of fresh air required:
- for the combustion air supply,
- to avoid the formation of dangerous unburned gas mixtures for appliances
not fitted with the device referred to in point 3.2.3,
- the conditions for the dispersal of combustion products,
- for forced draught burners and heating bodies intended to be equipped with
such burners, their characteristics, the requirements for assembly, to assist
compliance with the essential requirements applicable to finished appliances
and, where appropriate, the list of combinations recommended by the manufacturer.
1.2.2. The instructions for use and servicing intended for the user must contain
all the information required for safe use, and must in particular draw the
user's attention to any restrictions on use.
1.2.3. The warning notices on the appliance and its packaging must clearly
state the type of gas used, the gas supply pressure and any restrictions on
use, in particular the restriction whereby the appliance must be installed
only in areas where there is sufficient ventilation.
1.3. Fittings intended to be part of an appliance must be so designed and
built as to fulfil correctly their intended purpose when incorporated in accordance
with the instructions for installation. The instructions for installation,
adjustment, operation and maintenance must be provided with the fittings concerned.
2. MATERIALS
2.1. Materials must be appropriate for their intended purpose and must withstand
the technical, chemical and thermal conditions to which they will foreseeably
be subjected.
2.2. The properties of materials that are important for safety must be guaranteed
by the manufacturer or the supplier of the appliance.
3. DESIGN AND CONSTRUCTION
3.1. General
3.1.1. Appliances must be so constructed that, when used normally, no instability,
distortion, breakage or wear likely to impair their safety can occur.
3.1.2. Condensation produced at the start-up and/or during use must not affect
the safety of appliances.
3.1.3. Appliances must be so designed and constructed as to minimize the risk
of explosion in the event of a fire of external origin.
3.1.4. Appliances must be so constructed that water and inappropriate air
penetration into the gas circuit does not occur.
3.1.5. In the event of a normal fluctuation of auxiliary energy, appliances
must continue to operate safely.
3.1.6. Abnormal fluctuation or failure of auxiliary energy or its restoration
must not lead to an unsafe situation.
3.1.7. Appliances must be so designed and constructed as to obviate hazards
of electrical origin. In the area in which it applies, compliance with the
safety objectives in respect of electrical hazards laid down in Directive
73/23/EEC (;) shall be equivalent to fulfillment of this requirement.
3.1.8. All pressurized parts of an appliance must withstand the mechanical
and thermal stresses to which they are subjected without any deformation affecting
safety.
3.1.9. Appliances must be so designed and constructed that failure of a safety,
controlling or regulating device may not lead to an unsafe situation.
3.1.10. If an appliance is equipped with safety and controlling devices, the
functioning of the safety devices must not be overruled by that of the controlling
devices.
3.1.11. All parts of appliances which are set or adjusted at the stage of
manufacture and which should not be manipulated by the user or the installer
must be appropriately protected.
3.1.12. Levers and other controlling and setting devices must be clearly marked
and give appropriate instructions so as to prevent any error in handling.
Their design must be such as to preclude accidental manipulation.
3.2. Unburned gas release
3.2.1. Appliances must be so constructed that the gas leakage rate is not
dangerous.
3.2.2. Appliances must be so constructed that gas release during ignition
and re-ignition and after flame extinction is limited in order to avoid a
dangerous accumulation of unburned gas in the appliance.
3.2.3. Appliances intended to be used in indoor spaces and rooms must be fitted
with a special device which avoids a dangerous accumulation of unburned gas
in such spaces or rooms. Appliances which are not fitted with such devices
must be used only in areas where there is sufficient ventilation to avoid
a dangerous accumulation of unburned gas. Member States may define on their
territory adequate space ventilation conditions for the installation of such
appliances, bearing in mind the features peculiar to them. Large-scale kitchen
appliances and appliances powered by gas containing toxic components must
be equipped with the aforesaid device.
3.3. Ignition Appliances must be so constructed that, when used normally:
- ignition and re-ignition is smooth, - cross-lighting is assured.
3.4. Combustion
3.4.1. Appliances must be so constructed that, when used normally, flame stability
is assured and combustion products do not contain unacceptable concentrations
of substances harmful to health. (;) OJ No L 77, 26. 3. 1973, p. 29.
3.4.2. Appliances must be so constructed that, when used normally, there will
be no accidental release of combustion products.
3.4.3. Appliances connected to a flue for the dispersal of combustion products
must be so constructed that in abnormal draught conditions there is no release
of combustion products in a dangerous quantity into the room concerned.
3.4.4. Independent flueless domestic heating appliances and flueless instantaneous
water heaters must not cause, in the room or space concerned, a carbon monoxide
concentration likely to present a danger to the health of persons exposed,
bearing in mind the foreseeable duration of their exposure.
3.5. Rational use of energy Appliances must be so constructed as to ensure
rational use of energy, reflecting the state of the art and taking into account
safety aspects.
3.6. Temperatures
3.6.1. Parts of appliances which are intended to be placed in close proximity
to the floor or other surfaces must not reach temperatures which present a
danger in the surrounding area.
3.6.2. The surface temperature of knobs and levers of appliances intended
to be manipulated must not present a danger to the user.
3.6.3. The surface temperatures of external parts of appliances intended for
domestic use, with the exception of surfaces or parts which are associated
with the transmission of heat, must not under operating conditions present
a danger to the user and in particular to children, for whom an appropriate
reaction time must be taken into account.
3.7. Foodstuffs and water used for sanitary purposes Without prejudice to
the Community rules in this area, materials and components used in the construction
of an appliance, which may come into contact with food or water used for sanitary
purposes, must not impair their quality.
ANNEX II
PROCEDURE FOR CERTIFICATION OF CONFORMITY
1. EC TYPE-EXAMINATION
1.1. The EC type-examination is that part of the procedure by which a notified
body checks and certifies that an appliance, representative of the production
envisaged, meets the provisions of this Directive which apply to it.
1.2. The application for type-examination must be lodged by the manufacturer
or his authorized representative established within the Community with a single
notified body.
1.2.1. The application must include:
- the name and address of the manufacturer and, if the application is lodged
by the authorized representative, his name and address,
- a written declaration that the application has not been lodged with any
other notified body,
- the design documentation, as described in Annex IV.
1.2.2. The manufacturer must place at the disposal of the notified body an
appliance, representative of the production envisaged, hereinafter called
'type'. The notified body may request further samples of the type if needed
for the test program. The type may additionally cover variants of the product
provided that those variants do not have different characteristics with respect
to types of risk.
1.3. The notified body must:
1.3.1. examine the design documentation and verify that the type has been
manufactured in conformity with the design documentation and identify the
elements which have been designed in accordance with the applicable provisions
of the standards referred to in Article 5 and the essential requirements of
this Directive;
1.3.2. perform, or have performed, the appropriate examinations and/or tests
to check whether the solutions adopted by the manufacturer meet the essential
requirements where the standards referred to in Article 5 have not been applied;
1.3.3. perform, or have performed, the appropriate examinations and/or tests
to check whether the applicable standards have effectively been applied where
the manufacturer has chosen to do so, thereby assuring conformity with the
essential requirements.
1.4. Where the type satisfies the provisions of this Directive, the notified
body must issue an EC type- examination certificate to the applicant. The
certificate must contain the conclusions of the examination, the conditions,
if any, for its validity and the necessary data for identification of the
approved type and, if relevant, descriptions of its functioning. Relevant
technical elements such as drawings and diagrams must be annexed to the certificate.
1.5. The notified body must inform the other notified bodies forthwith of
the issuing of the EC type- examination certificate and any additions to the
said type as referred to in point 1.7. They may obtain a copy of the EC type-examination
certificate and/or its additions and on a reasoned request may obtain a copy
of the Annexes to the certificate and the reports on the examinations and
tests carried out.
1.6. A notified body which refuses to issue or withdraws an EC type-examination
certificate must inform the Member State which notified it and the other notified
bodies accordingly, giving the reasons for its decision.
1.7. The applicant must keep the notified body that has issued the EC type-examination
certificate informed of all modifications to the approved type which might
affect conformity with the essential requirements. Modifications to the approved
type must receive additional approval from the notified body that issued the
EC type-examination certificate where such changes affect conformity with
the essential requirements or the prescribed conditions for use of the appliance.
This additional approval is to be given in the form of an addition to the
original EC type-examination certificate.
2. EC DECLARATION OF CONFORMITY TO TYPE
2.1. The EC declaration of conformity to type is that part of the procedure
whereby the manufacturer declares that the appliances concerned are in conformity
with the type as described in the EC type-examination certificate and satisfy
the essential requirements of this Directive which apply to them. The manufacturer
must affix the EC mark on each appliance and draw up a written declaration
of conformity. The declaration of conformity may cover one or more appliances
and must be kept by the manufacturer. The EC mark must be accompanied by the
identification symbol of the notified body responsible for the random checks
set out in point 2.3.
2.2. The manufacturer must take all necessary measures to ensure that the
manufacturing process, including final product inspection and testing, results
in homogeneity of production and conformity of the appliances with the type
as described in the EC type-examination certificate and with the requirements
of this Directive which apply to them. A notified body, chosen by the manufacturer,
must carry out random checks on the appliances as set out in point 2.3.
2.3. On-site checks of appliances must be undertaken at random by the notified
body at intervals of one year or less. An adequate number of appliances must
be examined and appropriate tests as set out in the applicable standards referred
to in Article 5 or equivalent tests must be carried out in order to ensure
conformity with the corresponding essential requirements of this Directive.
The notified body shall in each case determine whether these tests need to
be carried out in full or in part. Where one or more appliances are rejected,
the notified body shall take the appropriate measures to prevent the marketing
thereof.
3. EC DECLARATION OF CONFORMITY TO TYPE (guarantee of production quality)
3.1. The EC declaration of conformity to type (guarantee of production quality)
is the procedure whereby a manufacturer who fulfils the obligations in point
3.2 declares that the appliances concerned are in conformity with the type
as described in the EC type-examination certificate and satisfy the essential
requirements of this Directive which applies to them. The manufacturer must
affix the EC mark to each appliance and draw up a written declaration of conformity.
This declaration may cover one or more appliances and must be kept by the
manufacturer. The EC mark must be accompanied by the identification symbol
of the notified body responsible for EC surveillance.
3.2. The manufacturer shall apply a quality system that ensures conformity
of the appliances with the type as described in the EC type-examination certificate
and with the essential requirements of this Directive which apply to them.
The manufacturer is subject to EC surveillance as specified in point 3.4.
3.3. Quality system
3.3.1. The manufacturer must lodge an application for approval of his quality
system with a notified body of his choice for the appliances in question.
The application must include: - the quality system documentation, - an undertaking
to carry out the obligations arising from the quality system as approved,
- an undertaking to maintain the approved quality system to ensure its continuing
suitability and effectiveness, - documentation relating to the approved type
and a copy of the EC type-examination certificate.
3.3.2. All the elements, requirements and provisions adopted by the manufacturer
must be documented in a systematic and logical manner in the form of measures,
procedures and written instructions. This quality system documentation must
permit a uniform interpretation of the quality programs, plans, manuals
and records. It shall contain, in particular, an adequate description of:
- the quality objectives, the organizational structure and responsibilities
of management and of their powers with regard to appliance quality, - the
manufacturing processes, quality control and quality assurance techniques
and systematic actions that will be used, - the examinations and tests that
will be carried out before, during and after manufacture and the frequency
with which they will be carried out, - the method of monitoring attainment
of the required appliance quality and the effective operation of the quality
system.
3.3.3. The notified body shall examine and evaluate the quality system to
determine whether it satisfies the requirements referred to in point 3.3.2.
It will presume conformity with these requirements in respect of quality systems
that implement the corresponding harmonized standard. It must notify its decision
to the manufacturer and inform the other notified bodies thereof. The notification
to the manufacturer must contain the conclusions of the examination, the name
and address of the notified body and the reasoned assessment decision in respect
of the appliances concerned.
3.3.4. The manufacturer must keep the notified body that has approved the
quality system informed of any updating of the quality system in relation
to changes brought about by, for example, new technologies and quality concepts.
The notified body must examine the proposed modifications and decide whether
the modified quality system complies with the relevant provisions or whether
reappraisal is necessary. It must notify the manufacturer of its decision.
The notification must include the conclusions of the inspection and the reasoned
assessment decision.
3.3.5. A notified body that withdraws approval of a quality system must so
inform the other notified bodies, giving the reasons for the decision.
3.4. EC surveillance
3.4.1. The purpose of EC surveillance is to ensure that the manufacturer duly
fulfils the obligations arising out of the approved quality system.
3.4.2. The manufacturer must allow the notified body access for inspection
purposes to the place of manufacture, inspection, testing and storage and
must provide it with all necessary information, in particular: - the quality
system documentation, - the quality records, such as inspection reports and
test data, calibration data, reports on qualifications of the staff concerned,
etc.
3.4.3. The notified body must carry out a check at least once every two years
to ensure that the manufacturer is maintaining and applying the approved quality
system and must supply a report of the check to the manufacturer.
3.4.4. Furthermore, the notified body may make unannounced visits to the manufacturer.
During these visits, the notified body may carry out tests on appliances or
have them carried out. It must supply the manufacturer with an inspection
report and, if appropriate, a test report.
3.4.5. The manufacturer may supply the notified body's report on request.
4. EC DECLARATION OF TYPE CONFORMITY (guarantee of product quality)
4.1. The EC declaration of type conformity (guarantee of product quality)
is that part of the procedure whereby a manufacturer who fulfils the obligations
in point 4.2 declares that the appliances concerned are in conformity with
the type as described in the EC type-examination certificate and satisfy the
essential requirements of this Directive which apply to them. The manufacturer
must affix the EC mark to each appliance and draw up a written declaration
of conformity. This declaration may cover one or more appliances and must
be kept by the manufacturer. The EC mark must be accompanied by the identification
symbol of the notified body responsible for EC surveillance.
4.2. The manufacturer shall apply an approved quality system for the final
inspection of the appliances and the tests, as specified in point 4.3, and
is subject to EC surveillance as specified in point 4.4.
4.3. Quality system
4.3.1 Under this procedure, the manufacturer must lodge an application for
approval of his quality system with a notified body of his choice for the
appliances in question. The application must include: - the quality system
documentation, - an undertaking to carry out the obligations arising from
the quality system as approved, - an undertaking to maintain the approved
quality system to ensure its continuing suitability and effectiveness, - the
documentation relating to the approved type and a copy of the EC type-examination
certificate.
4.3.2. As part of the quality system, each appliance must be examined and
appropriate tests as laid down in the applicable standard(s) referred to in
Article 5 or equivalent tests carried out to check its conformity with the
essential requirements relating to it in this Directive. All the elements,
requirements and provisions adopted by the manufacturer must be documented
in a systematic and logical manner in the form of measures, procedures and
written instructions. This quality system documentation must permit a uniform
interpretation of the quality programs, plans, manuals and records. The
quality system documentation shall contain, in particular, an adequate description
of: - the quality objectives, the organizational structure and responsibilities
of management and of their powers with regard to appliance quality, - the
checks and tests to be carried out after manufacture, - the method of verifying
the effective operation of the quality system.
4.3.3. The notified body shall examine and evaluate the quality system to
determine whether it satisfies the requirements referred to in point 4.3.2.
It will presume conformity with these requirements in respect of quality systems
that implement the corresponding harmonized standard. It must notify the manufacturer
of its decision and inform the other notified bodies thereof. The notification
to the manufacturer must contain the conclusions of the examination, the name
and address of the notified body and the reasoned assessment decision for
the appliances concerned.
4.3.4. The manufacturer must keep the notified body which approved the quality
system informed of any adaptation of the quality system made necessary, e.g.
by new technology and quality concepts. The notified body must examine the
proposed changes and decide whether the amended quality system satisfies the
relevant provisions or whether a reassessment is necessary. It must notify
the manufacturer of its decision. The notification must contain the conclusions
of the inspection and the reasoned assessment decision.
4.3.5. A notified body which withdraws approval of a quality system must inform
the other notified bodies that it has done so and give reasons for its decision.
4.4. EC surveillance
4.4.1. The purpose of EC surveillance is to ensure that the manufacturer duly
fulfils the obligations arising out of the approved quality system.
4.4.2. The manufacturer must allow the notified body access for inspection
to the place of inspection, testing and storage and must provide it with all
necessary information, in particular: - the quality system documentation,
- the quality files such as inspection reports and test data, calibration
data, report on qualifications of the staff concerned, etc.
4.4.3. The notified body must carry out a check at least once every two years
to ensure that the manufacturer is maintaining and applying the approved quality
system and must supply a report on the check to the manufacturer.
4.4.4. Furthermore, the notified body may make unannounced visits to the manufacturer.
During these visits, the body may carry out tests on appliances or have them
carried out. It must supply the manufacturer with an inspection report and,
if appropriate, a test report.
4.4.5. The manufacturer may supply the notified body's report on request.
5. EC VERIFICATION
5.1. EC verification is that part of the procedure whereby a notified body
checks and certifies that the appliances are in conformity with the type as
described in the EC type-approval certificate and satisfy the essential requirements
of this Directive which apply to them.
5.2. EC verification may, at the choice of the manufacturer, be carried out
by checking and testing each appliance as specified in point 5.3 or by checking
and testing the appliance on a statistical basis as specified in point 5.4.
5.3. Verification by checking and testing each appliance
5.3.1. Each appliance must be examined and appropriate tests as defined in
the relevant standards referred to in Article 5 or equivalent tests must be
carried out in order to check its conformity with the relevant essential requirements
of this Directive.
5.3.2. The notified body must affix the EC mark on each approved appliance
and draw up a written certificate of conformity. The certificate may cover
one or more appliances and is kept by the manufacturer. The EC mark must be
accompanied by the identification symbol of the notified body.
5.4. Statistical verification
5.4.1. The manufacturer must submit his appliances in the form of homogeneous
batches and take all necessary measures to ensure that the manufacturing process
results in the homogeneity of each product batch.
5.4.2. Where appropriate, the manufacturer may affix the EC mark on each appliance
during the manufacturing process. The EC mark must be accompanied by the identification
symbol of the notified body responsible for the statistical verification.
5.4.3. Appliances must be subject to statistical control by attributes. They
should be grouped into identifiable batches consisting of units of a single
model which are manufactured under the same conditions. At random intervals
a batch is examined. The appliances constituting a sample are examined individually
and appropriate tests as laid down in the applicable standard(s) referred
to in Article 5 or equivalent tests are carried out to determine whether the
batch is to be accepted or rejected. A sampling plan with the following operating
characteristics is applied: - a standard quality level corresponding to a
95 % probability of acceptance with a percentage of non-conformity between
0,5 and 1,5 %, - a limit quality corresponding to a 5 % probability of acceptance
with a percentage of non-conformity between 5 and 10 %.
5.4.4. If a batch is accepted, the notified body must draw up a written certificate
of conformity which is kept by the manufacturer. All the appliances in the
batch may be placed on the market, except those in the sample which have been
identified as not conforming. If a batch is rejected, the competent notified
body must take the appropriate measures to prevent its being placed on the
market. Should batches be rejected frequently, the notified body may suspend
statistical verification.
6. EC VERIFICATION BY UNIT
6.1. EC verification by unit is the procedure whereby a notified body checks
and certifies that an appliance is in conformity with the requirements of
this Directive which apply to it. The notified body must affix the EC mark
on the appliance and draw up a written certificate of conformity. The certificate
is kept by the manufacturer.
6.2. The design documentation referred to in Annex IV must be made available
to the notified body.
6.3. The appliance must be examined and appropriate tests taking account of
the design documentation carried out in order to ensure conformity of the
appliance with the essential requirements of this Directive. If deemed necessary
by the notified body, the examinations and the appropriate tests may be carried
out after installation of the appliance.
ANNEX III
EC MARK AND INSCRIPTIONS
1. The EC mark consists of the symbol CE as shown below, followed by the last
two digits of the year in which the mark was affixed and the identification
symbol of the notified body that has carried out the random checks, EC surveillance
or EC verification.
2. The appliance or its data plate must bear the EC mark together with the
following inscriptions:
- the manufacturer's name or identification symbol,
- the trade name of the appliance,
- the type of electrical supply used, if applicable,
- the appliance category. Information needed for installation purposes may
be added according to the nature of the appliance.
ANNEX IV
DESIGN DOCUMENTATION
The design documentation must contain the following information, in so far
as is required by the notified body for assessment:
- a general description of the appliance,
- conceptual designs and manufacturing drawings and diagrams of components,
sub-assemblies, circuits, etc.,
- descriptions and explanations necessary for the understanding of the above,
including the operation of the appliances,
- a list of the standards referred to in Article 5, applied in full or in
part, and descriptions of the solutions adopted to meet the essential requirements
where the standards referred to in Article 5 have not been applied,
- test reports,
- manuals for installation and use. Where appropriate, the design documentation
must contain the following elements:
- attestations relating to the equipment incorporated in the appliance,
- attestations and certificates relating to the methods of manufacture and/or
inspection and/or monitoring of the appliance,
- any other document making it possible for the notified body to improve its
assessment.
ANNEX V
MINIMUM CRITERIA FOR ASSESSMENT OF NOTIFIED BODIES
The notified bodies designated by the Member States must fulfil the following
minimum conditions:
- availability of personnel and of the necessary means and equipment,
- technical competence and professional integrity of personnel,
- independence in carrying out tests, preparing reports, issuing certificates
and performing the surveillance provided for in this Directive, of management
and technical staff in relation to all circles, groups or persons directly
or indirectly involved in the field of the appliances,
- maintenance of professional secrecy by staff,
- possession of civil liability insurance unless that liability is covered
by the State under national law. Fulfillment of the conditions in the first
two indents must be periodically verified by the competent authorities of
the Member States or by bodies designated by the Member States.
