CELEX: 51988PC0786
Language: en
Date: 1989-01-16
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO APPLIANCES BURNING GASEOUS FUELS

21. 2. 89                              Official Journal of the European Communities                              No C 42/5
                                                               II
                                                       (Preparatory Acts)
                                                 COMMISSION
              Proposal for a Council Directive on the approximation of the laws of the Member States
                                         relating to appliances burning gaseous fuels
                                               COM(88)    786 final — SYN 178
                                    (Submitted by the Commission on 22 December 1988)
                                                         (89/C 42/04)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                           Whereas Community law provides — by way of dero-
                                                                   gation from one of the fundamental rules of the
                                                                    Community, namely the free movement of goods — that
Having regard to the Treaty establishing the European               obstacles to movement within the Community resulting
Economic Community, and in particular Article 100A                  from disparities in national legislation relating to the
thereof,                                                            placing on the market of products must be accepted in so
                                                                    far as such obstacles can be recognized as being
                                                                    necessary to satisfy mandatory requirements;
Having regard to the proposal from the Commission,
                                                                   Whereas the essential health and safety requirements
In cooperation with the European Parliament,
                                                                    must be observed in order to ensure that appliances
                                                                    burning gaseous fuels are safe; whereas energy conser-
                                                                   vation     is  considered    essential;  whereas     these
Having regard to the opinion of the Economic and                    requirements must be applied with discernment to take
Social Committee,                                                   account of the state of the art at the time of
                                                                    construction;
Whereas Member States have the responsibility of
ensuring on their territory the health and safety 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 this Directive therefore contains only
                                                                    mandatory and essential requirements; whereas, to
                                                                    facilitate proof of conformity with the essential
Whereas, in certain Member State, mandatory provisions              requirements, it is necessary to have harmonized
define in particular the safety level required of appliances        standards at European level in particular as to the
burning gaseous fuels by specifying design, operating               design, construction and testing of appliances burning
characteristics and inspection procedures; whereas these            gaseous fuels so that products complying with them may
mandatory provisions do not necessarily lead to different           be assumed to conform to the essential requirements;
safety levels from one Member State to another but do,              whereas these standards, harmonized at European level,
by their disparity, hinder trade within the Community;              are drawn up by private bodies and must remain
                                                                    non-mandatory texts; whereas for that purpose the
                                                                    European Committee for Standardization (CEN) and
Whereas different conditions as regards types of gas and            the European Committee for Electrotechriical Standardi-
supply pressures are in force in the Member States;                 zation (Cenelec) are recognized as the competent bodies
whereas these conditions are not harmonized because                 for the adoption of harmonized standards in accordance
each Member State's energy supply and distribution                  with the general guidelines for cooperation between the
situation is peculiar to it;                                        Commission and those two bodies signed on 13
                                                                    November 1984; whereas, for the purposes of this
                                                                    Directive, a harmonized standard is a technical specifi-
Whereas the White Paper on the completion of the                    cation (European standard or harmonization document)
internal market, approved by the European Council in                adopted by one or both of those bodies upon a remit
June 1985, provides in paragraphs 65 and 68 for a new               from the Commission in accordance with the provisions
 approach to legislative harmonization;                             of Council Directive 83/189/EEC of 28 March 1983
 ---pagebreak--- No C 42/6                              Official Journal of the European Communities                                21. 2. 89
laying down a procedure for the provision of infor-              HAS ADOPTED THIS DIRECTIVE:
mation in the field of technical standards and regu-
lations (*) and the abovementioned general guidelines;
                                                                                         CHAPTER I
Whereas, while awaiting the adoption of harmonized
standards within the meaning of this Directive,                      Scope, placing on the market and free movement
conformity with the ^essential requirements and the free
movement of appliances burning gaseous fuels should be
facilitated by the acceptance, at Community level, of                                      Article 1
products conforming to the national standards whose
conformity with the essential requirements has been               1.   This Directive shall apply to appliances burning
confirmed by a Community checking procedure;                     gaseous fuels used for cooking, heating, hot water
                                                                 production, refrigeration, lighting or washing and
                                                                 having, where        applicable,    an  operating     water
Whereas a check on compliance with the relevant                  temperature not exceeding 105 °C, hereinafter referred
technical requirements is necessary in order to provide          to as 'appliances'.
effective protection for users and third parties; whereas
the existing certification procedures differ from one
Member State to another; whereas, in order to avoid              2.    Appliances, specifically designed for use in
multiple inspections, which are in effect barriers to the        industrial processes are excluded from the scope defined
free movement of appliances burning gaseous fuels,               in paragraph 1.
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       3.    For the purposes of this Directive, 'gaseous fuel'
procedures should be set up and the criteria for                 means any fuel which is in a gaseous state at a
appointing the bodies responsible for carrying out these         temperature of 15 °C under a pressure of 1 bar.
procedures should be harmonized;
                                                                 4.    For the purposes of this Directive, 'normally used'
Whereas the Member States' responsibility on their               appliances means:
territory for safety, health and energy conservation
covered by the essential requirements must be recognized
in a safeguard clause providing for an adequate                  — when correctly installed, taking especially into
Community procedure;                                                 consideration the type of gas and the supply pressure
                                                                     used in the Member State of destination, and
Whereas the adressees of any decision taken under this
Directive must be informed of the reasons for such a             — when used with the normal variation of the gas
decision and the legal remedies available to them;                   quality and the normal fluctuation of the supply
                                                                     pressure and when regularly serviced, and
Whereas the Council adopted on 17 September 1984 a
framework        Directive      on      gas       appliances     — when used in accordance with its intended purpose
(84/530/EEC) (2), and a separate Directive on gas water              or in a way which can be reasonably foreseen.
heaters (84/531/EEC) ( J ); whereas those Directives
cover the same area as this Directive and should
therefore be repealed;
                                                                                           Article 2
                                                                  1.   Member States shall take all necessary steps to
Whereas the measures aimed at the gradual estab-                 ensure that the appliances referred to in Article 1 may be
lishment of the internal market must be adopted by 31            placed on the market and put into service only if, when
December 1992; whereas the internal market consists of           normally used, they do not compromise the safety of
an area without internal frontiers in which the free             persons, domestic animals and property.
movement of goods, persons, services and capital is
ensured,
                                                                 2.    Member States shall communicate the types of gas
                                                                 and corresponding supply pressures used on their
                                                                 territory to the other Member States and the
O OJ No L 109, 26. 4. 1983, p. 8.                                Commission. The latter shall ensure that they are
(2) OJ No L 300, 19. 11. 1984, p. 95.                            published in the Official Journal of the European
(») OJ No L 300, 19. 11. 1984, p. 106.                            Communities.
 ---pagebreak--- 21. 2. 89                              Official Journal of the European Communities                              No C 42/7
                           Article 3                             2.      After receipt of the communication referred to in
                                                                 Article 5 (2) the Commission shall consult the
Appliances as referred to in Article 1 shall satisfy the          Committee. Upon receipt of the latter's opinion, the
relevant essential requirements set out in Annex I.               Commission shall, within one month, inform the
                                                                  Member States whether or not the national standard(s)
                           Article 4                             in question are to enjoy the presumption of conformity;
                                                                  if so, the Member States shall publish the reference
1.     Member States shall not impede the placing on the          number(s) of the (those) standard(s). The Commission
market and the putting into service of appliances which           shall also publish them in the Official Journal of the
satisfy the requirements of this Directive.                       European Communities.
2.     Member States shall not impede the placing on the
market for professional use of safety and controlling                                        Article 7
devices, hereinafter referred to as 'devices', which are
designed to be part of an appliance and whose charac-              1.    Where a Member State finds that normally used
teristics are stated in an attestation as referred to in          appliances bearing the CE mark might compromise the
Article 8 (4).                                                    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
                           Article 5                              being placed on the market.
1.     Member States shall presume compliance with the
relevant essential requirements referred to in Article 3 in       The Member State concerned shall immediately inform
respect of appliances and devices which are designed for          the Commission of any such measure, indicating the
incorporation in an appliance when conforming to:                 reasons for its decision and, in particular, whether
                                                                  non-compliance is due to:
(a) the relevant national standards implementing the
     harmonized standards, whose reference numbers
     have been published in the Official Journal of the            (a) failure to meet the essential requirements referred to
     European Communities.                                              in Article 3, where the standards referred to in
                                                                        Article 5(1) have not been applied;
     Member States shall publish the reference numbers
     of the said national standards;
                                                                   (b) incorrect application of the standards referred to in
(b) the relevant national standards referred to in                      Article 5 (1);
     paragraph 2 in so far as, in the areas covered by such
     standards, no harmonized standards exist.                     (c) shortcomings in the applied standards referred to in
                                                                        Article 5 (1) themselves.
 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              2.     The Commission shall enter into consultation with
 complying with the essential requirements referred to in          the parties concerned as soon as possible. Where, after
Article 3. The Commission shall forward these national             such consultation, the Commission finds that any
 standards forthwith to the other Member States. In                measure as referred to in paragraph 1 is justified, it shall
 accordance with the procedure provided for in Article 6           immediately so inform the Member State that took the
 (2), it shall notify the Member States of those national          action and the other Member States.
 standards in respect of which there is a presumption of
 conformity with the essential requirements referred to in
                                                                   Where the decision referred to in paragraph 1 is
 Article 3.
                                                                   attributed to shortcomings in the standards, the
                                                                   Commission, after consulting the parties concerned, shall
                           Article 6                               bring the matter before the Committee within two
                                                                   months if the Member State which has taken the
 1.    Where a Member State or the Commission                      measures intends to maintain them, and shall initiate the
 considers that the standards referred to in Article 5 (1)         procedures referred to in Article 6.
 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              3.     Where an appliance which does not comply bears
 Committee set up under Directive 83/189/EEC, here-                the CE mark, the competent Member State shall take
 inafter referred to as 'the Committee', giving the reasons        appropriate action against whomsoever has affixed the
 therefor. The Committee shall deliver an opinion without          mark and shall inform the Commission and the other
 delay.                                                            Member States thereof.
 In the light of the Committee's opinion, the Commission
 shall inform the Member States whether or not it is               4.     The Commission shall ensure that the Member
 necessary to withdraw those standards from the publi-             States are kept informed of the progress and outcome of
 cations referred to in Article 5 (1).                             this procedure.
 ---pagebreak--- No C 42/8                              Official Journal of the European Communities                                 21. 2. 89
                         CHAPTER II                                                         Article 9
             Means of attestation of conformity                   1.    Each Member State shall communicate to the other
                                                                 Member States and to the Commission the notified
                                                                 bodies responsible for carrying out the procedures
                           Article 8                             referred to in Article 8.
1.    The means of attestation of conformity of series-
manufactured appliances shall be:                                The Commission shall publish, in the Official Journal of
                                                                  the European Communities, a list of the notified bodies
(a) at the design level: the EC-type examination as              with their identification symbols and shall ensure that the
     referred to in Annex II (1); and                            list is kept up to date.
(b) prior to their being placed on the market, at the
     choice of the manufacturer:                                 2.     Member States shall apply the criteria set out in
                                                                 Annex V for the evaluation of the bodies to be notified.
     — the EC declaration of production conformity
         (type 1) referred to in Annex II (2), or
                                                                 Bodies which satisfy the criteria for evaluation set out in
     — the EC declaration of production conformity               the relevant harmonized standards shall be presumed to
         (type 2) referred to in Annex II (3), or                be in conformity with the criteria set out in that Annex.
     — the EC verification (type 1) referred to in Annex
         II (4).
                                                                 3.     A Member State which has notified a body must
                                                                 withdraw approval if it finds that the body no longer
2.    The means of attestation of conformity in the case         meets the criteria referred to in paragraph 2. It shall
of production of an appliance as a single unit shall be the      immediately inform the other Member States and the
EC verification (type 2) referred to in Annex II (5).            Commission accordingly.
3.    After completion of the procedures referred to in
paragraphs 1 (b) and 2 the CE mark of conformity shall
be affixed to conforming appliances in accordance with                                   CHAPTER III
Article 10.
                                                                                    CE mark of conformity
4.    The procedures referred to in paragraph 1 shall be
applied in respect of devices as referred to in Article 4                                   Article 10
(2) which are designed to be part of an appliance.
However, no CE mark of conformity shall be affixed to             1.    The CE mark of conformity and the inscriptions as
the device; instead an attestation shall be issued stating       set out in Annex III shall be affixed in a visible, easily
its characteristics.                                             legible and indelible form to the appliance or to a data
                                                                 plate attached to it. The data plate shall be so designed
The attestation shall accompany the device.                      that it cannot be re-used.
5.     Where the appliances are also subject to other            2.     The affixing to appliances of marks which are likely
Community Directives:                                            to be confused with the CE mark shall be prohibited.
— the appliances shall be checked to ensure compliance
    with the requirements of this Directive in accordance                                   Article 11
    with the procedures stated in paragraphs 1 and 2,
    and                                                          Where it is established that the CE mark has been
                                                                 wrongly affixed to appliances or that the attestation for
— it shall be ensured that the appliances also comply            devices has been wrongly attributed because:
    with the requirements of the other Directives in
    accordance with the relevant procedures in those             — the appliances or the devices do not conform to the
    Directives.                                                       appliance or the device as referred to in the EC type-
                                                                      approval certificate,
The affixing of the CE mark as referred to in paragraph
3 shall attest that the provisions of all relevant Directives
are satisfied.                                                   — the appliances or the devices conform to the
                                                                      appliance or the device as referred to in the EC type-
                                                                      approval certificate but which do not meet the
6.     Records and correspondence relating to the means
                                                                      essential requirements applicable to them,
of attestation of conformity shall be drafted in the
official language(s) of the Member State(s) where the
said procedures are to be carried out or in a language           — the manufacturer has failed to fulfil his obligations as
accepted by the notified body concerned.                              specified in Annex II,
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the notified body shall withdraw the right to affix the                                            Article 13
CE mark or to issue the attestation and shall so inform
the other notified bodies and report to the Member State                Directives 84/530/EEC and 84/531/EEC are hereby
concerned.                                                              repealed.
                                                                                                   Article 14
                       CHAPTER IV                                       1.    Before 1 January 1991 Member States shall adopt
                                                                        and publish the laws, regulations and administrative
                      Final provisions
                                                                        provisions necessary in order to comply with this
                                                                        Directive. They shall inform the Commission thereof.
                         Article 12
                                                                        They shall apply such provisions from 31 December
Any decision taken pursuant to this Directive which                     1992.
results in restrictions on the placing on the market
and/or putting into service of an appliance shall state the             2.    Member States shall communicate to the
precise grounds on which it is based. Such a decision                   Commission the texts of the provisions of national law
shall be notified without delay to the party concerned,                 which they adopt in the field covered by this Directive.
who shall at the same time be informed of the legal
remedies available to him under the laws in force in the
                                                                                                   Article 15
Member State in question and of the time limits to which
such remedies are subject.                                              This Directive is addressed to the Member States.
                                                                ANNEX I
             1.        ESSENTIAL REQUIREMENTS
             1.1.      General conditions
             1.1.1.    An appliance shall be so designed and built as to operate safely and present no danger to
                       persons, domestic animals and property during a reasonable lifetime when normally used as
                       defined in Article 1 (4).
             1.1.2.    When placing the appliance on the market, the manufacturer's instructions for:
                       — installation, servicing and adjustment, intended for the installer,
                       — safe use and servicing, intended for the user,
                       shall be provided with the appliance in the official language(s) of the Member State of desti-
                       nation.
             1.1.3.    A device intended to be part of an appliance shall be so designed and built as to operate
                       correctly for its intended purpose, when incorporated in accordance with the device manu-
                       facturer's instructions.
                       The instructions for installation, adjustment, operation and maintenance shall be provided with
                       the device.
             1.2.      Materials
             1.2.1.    Materials shall be appropriate for their intended purpose and shall withstand the mechanical,
                       chemical and thermal conditions to which they will foreseeably be subjected.
             1.2.2.    The pertinent properties of materials that are relevant to safety shall be guaranteed by the
                       supplier or the manufacturer of the appliance.
             1.2.3.    The materials used in the gas circuit shall be such that in the presence of an external fire the risk
                       of an explosion shall be minimized.
             1.3.      Design and construction
             1.3.1.    General
             1.3.1.1.  The construction of an appliance shall be such that, when normally used, instability, distortion
                       or wear likely to impair its safety will not occur.
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            1.3.1.2.  Condensation produced at the start-up and/or during use shall not affect the safe operation of
                      the appliance.
            1.3.1.3.  The construction of the appliance shall be such that water and inappropriate air penetration into
                      the gas circuit shall not occur.
            1.3.1.4.  In the case of a normal fluctuation of auxiliary energy the appliance shall continue to operate
                      safely.
            1.3.1.5.  Abnormal fluctuation or failure of auxiliary energy and its restoration shall not lead to an unsafe
                      situation.
            1.3.1.6.  Where electricity is used with a nominal value outside the ranges of 50 to 1 000 V in the case of
                      alternating current and 75 to 1 500 V in the case of continuous current, the appliance shall also
                      be so designed and constructed as to avoid electrical hazards.
            1.3.1.7.  Pressurized parts of an appliance shall withstand, without deformation which impairs its safety,
                      the mechanical and thermal stresses to which they are subjected.
            1.3.1.8.  An appliance shall be so designed and constructed that failure of a device shall not lead to an
                      unsafe situation.
            1.3.1.9.  If an appliance is equipped with safety and controlling devices, the functioning of the safety
                      devices shall not be overruled by the functioning of the controlling devices.
            1.3.1.10. All parts of an appliance which are set at the stage of manufacture and which should not be
                      manipulated by the user and the installer shall be appropriately protected.
            1.3.2.     Unburned gas release
            1.3.2.1.  The construction of an appliance shall be such that the gas leakage rate of an appliance shall be
                      limited to a risk-free amount.
            1.3.2.2.  The construction of an appliance shall be such that gas release during ignition and/or
                      re-ignition and after flame extinction shall be limited in order to avoid a dangerous accumu-
                      lation of unburned gas in the appliance.
            1.3.3.      Ignition
                      The construction of the appliance shall be such that, when normally used:
                      — ignition and re-ignition shall be smooth, and
                      — cross-lighting shall be assured.
            1.3.4.      Combustion
            1.3.4.1.  The construction of the appliances shall be such that, when normally used, the flame stability
                       shall be assured and the combustion products shall not contain unacceptable concentrations of
                       harmful elements.
            1.3.4.2.   The construction of an appliance shall be such that, when used normally, and also in abnormal
                       draught conditions for appliances which are connected to a flue, there will be no unintended
                       escape of combustion products.
            1.3.4.3.   Instantaneous water heaters and individual heaters, not connected to a flue, shall not cause a
                       carbon monoxide concentration in the room exceeding a value of 0,01 %.
            1.3.5.      Efficiency
                       An appliance shall have a minimum efficiency taking into account the state of the art.
            1.3.6.      Temperatures
             1.3.6.1.  Parts of an appliance which are intended to be placed in close proximity to the floor or other
                       surfaces shall not reach temperatures which present a danger to the surroundings.
             1.3.6.2.  The surface temperatures of knobs and handles of appliances intended to be manipulated shall
                       not reach values which present a danger to the user.
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            1.3.6.3. The surface temperatures of external parts of an appliance intended for domestic use, with the
                     exception of surfaces or parts with the function of transmitting heat, shall under operating
                     conditions not exceed values which present a danger to the user and in particular to children for
                     whom an appropriate contact time has to be taken into account.
            1.3.7.   Foodstuffs and water used for sanitary purposes
                     Materials and components used for construction of an appliance, which may come into contact
                     with food or water used for sanitary purposes, shall not impair their quality.
                                                                ANNEX        II
                                  PROCEDURES FOR ATTESTATION O F CONFORMITY
            1.       EC-TYPE EXAMINATION
            1.1.     The EC-type examination is that part of the procedure by which a notified body ascertains and
                     certifies that an appliance, representative of the production envisaged, meets the provisions of
                     the Directive that apply to it.
            1.2.     The application for the type examination shall be lodged by the manufacturer or his authorized
                     representative established within the Community with a single notified body.
            1.2.1.   The application shall include:
                     — the name and address of the manufacturer and, if the application is lodged by the authorized
                          representative, his name and address in addition,
                     — 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 shall 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 is needed for the text programme.
                     The type may additionally cover variants of the type provided that those variants do not have
                     different characteristics with respect to safety and efficiency.
            1.3.     The notified body shall:
            1.3.1.   examine the design documentation and verifiy that the type has been manufactured in
                     conformity with the design documentation and identify the elements which have been designed
                     in accordance with the relevant provisions of the standards and the elements which have been
                     designed in accordance with the essential requirements of the Directive;
            1.3.2.    perform or have performed the appropriate examination 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
                     relevant standards were effectively applied where the manufacturer has chosen to do so, thereby
                      assuring conformity with the essential requirements. Where the manufacturer declares having
                      designed the product entirely to the standards and where conformity of the products to be
                      manufactured can be assessed without testing by the notified body, an EC type-examination
                      shall be carried out on the sole basis of the design documentation.
             1.4.     Where the type meets the provisions of the Directive the notified body shall issue an EC type-
                      approval certificate to the applicant. The certificate shall contain the conclusions of the exam-
                      ination, 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 schemes shall be annexed to the certificate.
             1.5.     The notified body shall inform the other notified bodies forthwith of the issuing of the EC
                      type-approval certificate and additions as referred to in 1.7, if any, on the said type. They may
                      obtain a copy of the EC type-approval 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.
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            1.6. A notified body that refuses to issue or withdraws an EC type-approval certificate shall so
                 inform the Member State which notified this body and the other notified bodies, giving the
                 reasons for the decision.
            1.7. The applicant shall keep the notified body that has issued the EC type-approval certificate
                 informed of all modifications to the approved type with respect to the essential requirements.
                 Modifications   to the approved type must receive additional approval from the notified body that
                 issued the EC   type-approval certificate where such changes affect the essential requirements or
                 the prescribed  conditions for use of the appliance. This additional approval is given in the form
                 of an addition  to the original EC type-approval certificate.
            2.   EC DECLARATION OF P R O D U C T I O N CONFORMITY (type 1)
            2.1. The EC declaration of production conformity (type 1) 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-approval certificate and satisfy the requirements of this Directive that
                 apply to them. The manufacturer shall draw up a written declaration of conformity and he or
                 his authorized representative in the Community shall affix the CE mark on each appliance. The
                 declaration of conformity shall cover either individual or several appliances and be kept by the
                 manufacturer. The CE mark shall be accompanied by the identification symbol of the notified
                 body responsible for the random checks set out in 2.3.
            2.2. The manufacturer shall take all measures necessary in order that the manufacturing process
                 including final product inspection and testing shall ensure homogeneity of production and
                 conformity of the appliances with the type as described in the EC type-approval certificate and
                 with the requirements of the Directive that apply to them. A notified body, chosen by the manu-
                 facturer, shall carry out random checks on the appliances as set out in either 2.3 (a) or 2.3 (b).
            2.3. (a) The appliances shall be subject to statistical control by attributes and shall therefore be
                     grouped into identifiable batches consisting of units of a single model which are manu-
                     factured under essentially the same conditions. At random intervals a batch shall be
                     examined to determine conformity by applying a sampling plan with the following operating
                     characteristics:
                     — a standard quality level of the batch submitted, corresponding to a 95 % probability of
                         acceptance with a percentage of non-conformity between 0,5 and 1,5 % ,
                     — a limiting quality of the batch submitted, corresponding to a 5 % probability of
                         acceptance with a percentage of non-conformity between 5 and 10 %.
                      In those cases where a batch is rejected the notified body shall take the appropriate
                      measures to prevent the putting on the market of the batch.
            2.3. (b) On-site checks of appliances shall be undertaken at random intervals of one year or less. An
                      adequate number of appliances shall be examined and appropriate tests as set out in the
                     relevant standards referred to in Article 5 or equivalent tests shall be carried out in order to
                     ensure conformity with the relevant requirements of the Directive. In those cases where one
                     of the appliances under examination does not conform, the notified body shall take
                      measures appropriate to the nature of the defect(s) and it shall also inform the other notified
                     bodies of such measures taken.
            3.   EC DECLARATION OF P R O D U C T I O N CONFORMITY (type 2)
            3.1. The EC declaration of production conformity (type 2) is the procedure whereby the manu-
                 facturer who satisfies the obligations of 3.2 declares that the appliances concerned are in
                 conformity with the type as described in the EC type-approval certificate and satisfy the
                 requirements of this Directive that apply to them. The manufacturer shall affix the CE mark to
                 each appliance and draw up a written declaration of conformity. This declaration shall cover
                 either individual or several appliances and be kept by the manufacturer. The CE mark shall be
                 accompanied by the identification symbol of the notified body responsible for EC surveillance.
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            3.2.   The manufacturer shall have adequately implemented a quality system that will ensure
                   conformity of the appliances with the type as described in the EC type-approval certificate and
                   with the requirements of this Directive that apply to them. The manufacturer is subject to EC
                   surveillance as specified in 3.4.
            3.3.   Quality system
            3.3.1. The manufacturer shall lodge an application for approval of his quality system with a notified
                   body.
                   The application shall include:
                   — all relevant information, in particular the quality system documentation and the design docu-
                       mentation of the approved type,
                   — 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.
            3.3.2. All the elements, requirements and provisions adopted by the manufacturer shall be documented
                   in a systematic and orderly manner in the form of written policies, procedures and instructions.
                   This quality system documentation shall ensure a common understanding of the quality
                   programmes, 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 product 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 means to monitor the achievement of the required product 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 3.3.2. It shall presume conformity with these requirements in
                   respect of quality systems that implement the corresponding harmonized standard.
                   it shall notify its decision to the manufacturer and inform the other notified bodies thereof. The
                   notification shall contain the conclusions of the examination and the reasoned assessment
                   decision.
            3.3.4. The manufacturer shall 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, e.g. new tech-
                   nologies and quality concepts.
            3.3.5. A notified body that withdraws approval of a quality system shall 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 make sure that the manufacturer duly fulfils the obligations
                   arising out of the approved quality system.
            3.4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations
                   of manufacture, inspection, testing and storage and shall provide it with all necessary infor-
                   mation, in particular:
                   — the quality documentation,
                   — the design documentation,
                   — the quality records, such as inspection reports and test data, calibration data, qualification
                       reports of the personnel concerned, etc.
            3.4.3. The notified body shall make sure that the manufacturer maintains and applies the quality
                   system and shall provide a surveillance report to the manufacturer.
 ---pagebreak--- N o C 42/14                             Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s               2 1 . 2. 89
           4.          EC VERIFICATION (typel)
            4.1.       The EC verification is that part of the procedure whereby a notified body checks and attests that
                       the appliances are in conformity with the type as described in the EC type-approval certificate
                       and satisfy the requirements of the Directive that apply to them. The notified body shall affix
                       the CE mark to each appliance and draws up a written certificate of conformity.
                       The certificate shall cover individual or several appliances and be kept by the manufacturer.
            4.2.       Each appliance shall be examined and appropriate tests as set out in the relevant standards
                       referred to in Article 5 or equivalent tests shall be carried out in order to ensure conformity of
                       the appliance with the relevant requirements of the Directive.
            5.         EC VERIFICATION (type 2)
            5.1.       The EC verification is a procedure whereby a notified body checks and attests that an appliance
                       is in conformity with the requirements of the Directive that apply too it. The notified body shall
                       affix the CE mark to the appliance and draw up a written certificate of conformity.
                       The certificate shall be kept by the manufacturer.
            5.2.       The design documentation as set out in Annex IV shall be made available to the notified body.
           5.3.        The appliance shall be examined and appropriate tests shall be carried out in order to ensure
                       conformity of the appliance with the requirements of the Directive.
                       If deemed necessary by the notified body, the examinations and the appropriate tests shall be
                       carried out after the installation of the appliance.
                                                                ANNEX      III
                                                 CE MARK A N D INSCRIPTIONS
            1. The CE mark shall consist of the symbol CE as given below, 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, the EC surveillance or the EC verification.
           2. The appliance or data plate must bear the CE mark together with the following inscriptions:
               — the manufacturer's name or identification symbol,
               — the trade name of the appliance,
               — the electrical supply used, if applicable,
               — the appliance category.
               Additional information needed for installation shall be added according to the nature of the different
               appliances.
 ---pagebreak--- 21. 2. 89                              Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                  N o C 42/15
                                                                ANNEX      IV
                                                  DESIGN D O C U M E N T A T I O N
          The design documentation shall contain the following information, so far as is required by the notified
          body for assessment:
          — a general description of the appliance,
          — conceptual designs and manufacturing drawings and schemes 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,
          — the manuals for installation and for the user.
                                                                ANNEX      V
                           MINIMUM CRITERIA FOR EVALUATION O F 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 the reports; issuing the certificates and performing the
              surveillance provided for in this Directive, of staff and personnel in relation to all circles, groups or
              persons directly or indirectly concerned with appliances,
          — maintenance of professional secrecy by personnel,
          — subscription of a civil liability insurance unless that liability is covered by the State under national law.
          Fulfilment of the conditions in the first and second indents shall be verified at intervals by the competent
          authorities of the Member State or by bodies designated by the Member State.