CELEX: 51988PC0786R(01)
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 (presented by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (88) 786
Vol. 1988/0256
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITÎES
                                           COM(88 ) 786 final - SYN 178
                                           Brussels , 16 January 1989
                                           Revised version
                            Proposai for a
                          COUNCIL DIRECTIVE
      on the approximation of the laws of the Member States
           relating to appliances burning gaseous fuels
                   ( presented by the Commission )
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 ---pagebreak---                               EXPLANATORY MEMORANDUM
  i.     General
  1.    SuhJ.efit
        This proposal for a directive has been prepared in applica¬
         tion of the Council Resolution of 7 May 1985 1 on a new
        approach to technical harmonization and standards . It is
        part of the work programme set out in the White Paper which
        should lead to the completion of the internal market by the
        end of 1992 .
        The area covered by this proposal comprises non-industrial
        appliances burning gaseous fuels , hereinafter referred to as
         " appliances ", including appliances manufactured in series as
        well as single units .
        The aim of this directive is to harmonize national pro¬
        visions concerning safety and energy conservation , thereby
        ensuring elimination of technical barriers to trade arising
        out of the disparities in such national provisions .
        In the context of these objectives it has to be noted that
       different conditions with regard to the types of gas and
       supply pressures are in force in the Member States . There ¬
        fore the manufacturer when designing appliances has to take
        the above mentioned conditions into account .
1    O.J. E ° 0 133     4.6 . 1985 , p. 1
 ---pagebreak---                               2
 The essential requirements as set out in Annex I of the pro¬
 posal for a direotive will allow a high level of protection
 to be attained .
 The Commission has taken into account the requirements of
 Article 8.c ) of the Treaty in the preparation of this pro¬
 posal and has concluded that no special provision seems to
 be justified at this state .                                  ;
 Economic ^nd social    m A
The number of appliances in use throughout the Community
 exceeded 120 million units in 1985 . Approximately 15 million
applianoes were produced within the Community for its market
in the same year , 12 000 and 15 000 million ECU , whilst the
overall exports by Community manufacturers are estimated at
around 500 000 appliances per year , corresponding to a value
of around 400 million ECU .
It is no simple matter to assess the economio Impact of
existing trade barriers and to evaluate their cost . Further¬
more it should be noted that the seotor contains a large
number of small and medium-sized enterprises and barriers to
trade very often force them to concentrate on their local or
national markets , therefore not allowing expansion . The lost
opportunity costs resulting from this inability to expand or
take opportunities cannot readily be assessed by economic
analysis .
The Commission based the preparation of this directive on an
in-depth survey of the national regulations in force in the
different Member States . The survey highlighted considerable
differences , not only with regard to legal and technical
specifications , but also in the administrative procedures
for examinations , testing and inspection .
 ---pagebreak---                                    3
      The extent of these differences and their impact on   trade
      within the Community have become even clearer since   the
      implementation of the procedures for the provisions   of in¬
      formation in the field of technical regulations and   stan¬
      dards laid down by Directive 83 / 189 / EEC . 2
      There are no Community statistics on the number of accidents
      caused by use of appliances . Figures available in two Member
      States show a significant decline in accidents considering
      the increase in the gas quantity supplied and in the number
      of customers . One of the main reasons for the decline in
      those accidents attributed to failure of the appliances
      themselves has been the prescription of built-in safety
      devices in new appliances . The specific essential require¬
      ments set out in this proposal for a directive are designed
      to ensure , in conjunction with the other safety provisions ,
      a high level of protection throughout the Community and to
      make a contribution to further reducing the number of
      accidents and all the associated human and economic
      consequences .
3.
     From the start of the preparatory work the Commission has
     involved all the parties concerned , namely representatives
      of governments , European federations of manufacturers , gas
     industry , consumers and the CEN .
     The Commission will ensure that all the parties concerned ,
     including the consumer federations are involved in the
     elaboration ox harmonized standards .
2  O.J. n° L 109 , 26.4.1983 , p. 8
 ---pagebreak---                                       –
4.  The role of standardization
    The role of standardization is to codify in a free and non¬
    binding manner the state of the art as regards the means to
    be used to satisfy the obligations laid down by the essen¬
    tial requirements . Since , under the new approach , Member
    States will have to presume that produots manufactured in
    accordance with the harmonized standards comply with the
    essential requirements , the latter can , in the event of dis ¬
    pute , constitute an extremely important element with respect
    to the liability for the manufacturer .
    European standardization at the same time helps to achieve
    the objective of industrial rationalization , improves the
   quality and safety of appliances and offers the manufacturer
    some degree of security . The Commission already has the nec ¬
   essary instruments to promote the role of standardization ,
   namely financial resources provided for in the Community
   budget to finance the activities of CEN and the standardiza¬
   tion remits from the Commission to this body as provided for
   in Directive 83 / 189 / EEC , with consultation of the Standing
   Committee provided for in Article 5 thereof .
   Without underestimating the importance of these instruments ,
   which have already proved their effectiveness on the prac¬
   tical and political levels , it is dear that the success of
   standardization , and hence of the Directive itself , will
   depend to a large extent on the level of industry 's commit ¬
   ment to the standardization work .
   In the middle of 1988 CEN took the initiative of setting up
   a programming committee for appliances which is made up of
   representatives of the standards bodies and the industry .
 ---pagebreak---                                 5
 This committee has a threefold task :
     to identify standardization needs in relation to the
     essential requirements
     to establish a standardization programme and its priori ¬
     ties
     to supervise progress .
On the basis of the standardization programme the
Commission , after consultation of the Standing Committee set
up Tinder Directive 83 / 189 / EEC , will give standardization
remits to CEN in accordance with the procedure provided for
in Article 6 of that Directive .
However , in the field in question , given the broad scope of
the directive , it will probably take a relatively long time
for all the European standards concerned to become avail¬
able .
The Council Resolution of 7 May 1985 provided that , as a
temporary measure and while awaiting the availability of
European standards , the presumption of conformity of pro ¬
ducts to the directive could be proved by conformity to
national standards , whose correspondence to the essential
requirements of the directive will have been verified by the
Commission after consultation of the Standing Committee set
up under Directive 83 / 189 / EEC .
 ---pagebreak---                                    6
II .  The proposal for a directive
1.    Field of application
      The field of application of this proposal covers the broad
      area of appliances used for cooking , heating , hot water pro ¬
      duction , refrigeration , lighting or washing , regardless of
      whether those appliances are manufactured in series or are
      produced as a single unit . It includes all applications of
      those appliances , whether they are used for domestic ,
      commercial or industrial purposes . Appliances where the
     pressure vessel aspect plays a dominant role e.g. steam
     boilers and those appliances specifically designed for use
     in industrial processes are , because of their specific
     technical aspects , excluded .
2.   Means of attestation of conformity
     Considering the nature of the appliances and the specific
     risks involved , the means of attestation of conformity pro ¬
     vided for by the directive require at both the design and
     the manufacturing level the intervention of a notified third
     party .
     At the design level , a type examination is obligatory for
     each kind of appliance which is manufactured in series .
     At the manufacturing level three procedures are provided for
     in the case of series produced appliances , which allows the
     manufacturer to choose the most suitable procedure taking
     into account his manufacturing process .
 ---pagebreak---                                   7
     Two of these procedures are based on specific product
     inspection , the third being based on control of the
     manufacturing process through application of a quality
     assurance system .
     A special procedure is provided for in the case of the pro ¬
    duction of an appliance as a single unit , whereby a notified
    body checks and attests conformity of the appliance with the
    requirements of the directive . In this case a type-
    examination is not requested .
    Furthermore , the means of attestation of conformity include
    the procedure to be followed when the appliances are also
    subject to other Community directives . The CE-mark shall
    only be affixed when the requirements of all relevant direc¬
    tives are satisfied .
3 .
    The Commission has studied the question of the high level of
    safety , health , environmental and consumer protection re¬
    quired by the terms of Article 100 A(3 ). It has done so fol ¬
    lowing consultation with the industrial and social partners
    concerned and in the light of an analysis of the risks in¬
    herent in this area and of the current technical capabili ¬
    ties of European industry . The proposal takes full account
    of these considerations in the light of the overall objec¬
    tives of this provision of the Treaty .
    The essential requirements refer to safety and energy con¬
    servation and take into account the specific risks of
    appliances .
 ---pagebreak---                             8
Attention has been paid to the inclusion of requirements
which provide for intrinsic safety of appliances , in partic ¬
ular with regard to their combustion and to the evacuation
of combustion products .
With regard to energy conservation it has to be noted that ,
taking into account the state of the art , the provision
recjuires only a minimum of efficiency . It guarantees free
movement of the appliances , leaving it open to the manufac¬
turers and to the market to opt for better performance .
 ---pagebreak---                       FINANCIAL     RANDUM
         on the proposal for a Council directive on the
approximation of the laws of the Member States relating to
                appliances burning gaseous fuels
  I ni réduction
 The proposal for a directive relating to appliances burning
 gaseous fuels sets out the essential requirements with which
 those appliances must comply . Article 5 of the proposal
 mates a general reference to harmonized standards , as a
 priority , or to national standards , as a temporary measure
 where there are no European standards . Appliances manufac¬
 tured in accordance with these standards are presumed to
 comply with the relevant essential requirements of the
 directive .
 The Commission intends to help to step up European standard¬
 ization by giving CEN the task of preparing the necessary
 harmonized standards in the sector of appliances in accord¬
 ance with the general guidelines for cooperation between the
 Commission and CEN , as approved on 13 November 1984 . This
 work will be carried out in the context of standardization
 requests given to CEN in application of the framework agree¬
 ments signed on 10 October 1985 which will be prolonged and
 which allow for financial support from the Commission .
 The work described above , which is of limited duration , must
 be integrated into the general framework of the management
 of the directive , which is along term activity .
 ---pagebreak---                                      2
         Any figures can only be rough estimates as the planning work
         for European standardization is in the process of being
         organized .
  2.     Budget lines affected
         Article 775 : Community projects concerning the internal
                       market
         Item 7750 :   Harmonization of industrial and labour
                       legislation Multiannual activities for
                       strengthening European standardization bodies
 3.     Legal basis
 3.1 Council Resolution of 7 May 1985 3 on a new approach to
        technical harmonization and standards .
 3.2    Counoil directive on the approximation of the laws of the
        Member States relating to appliances burning gaseous fuels ,
        when adopted .
4.      Proposed classification
        Non-compulsory expenditure .
5.      Description and justification of the activities
5.1     Objectives
        The planned activities should help in particular with the
       preparation of harmonized standards satisfying the essential
       requirements of the directive on appliances , without which
       the directive would be difficult to apply . Moreover , the
       harmonized standards will help to boost the competitiveness
       of European industry .
3    O.J. n° C 136 , 4.6.1985 , p. 1
 ---pagebreak---                                   3
5.2  Parties  concerned
     In accordance with the Council Resolution of 7 May 1985
     standardization work is not the Commission 's responsibility
     but rather that of the European standards organizations .
6.   Type of expenditure and method of calculation
6.1 Type of expenditure
    Standardization requests under the framework agreement of 10
    October 1985 between the Commission and CEN .
6.2 Ca Iculat i on
    The amount of the financing of standardization services will
    be determined for each order voucher on the basis of the
    work given to contractors .
    It comprises the expenses borne by the central units of the
    European standards bodies for the implementation of the
    standardization programmes entrusted to them and a contri ¬
    bution to the expenses of the committees and technical work¬
    ing parties for the execution of these programmes . It also
    includes the private expenses of experts assigned specific
    work in this context .
    These expenses are calculated on the basis of the man / month
    unit which is currently worth 5 000 ECU .
    The work of preparing the harmonized standards will certain¬
    ly last at least until 1992 .
 ---pagebreak---                                      4
 7.   Financial impact of the activity on operating appropriations
 7.1  Schedule of commitment and payment appropriations :
      ( item 7750 )
                           CAs ( ECU )             PAs ( ECU )
      1989                   400  000                200  000
      1990                   400  000                400  000
      1991                   400  000                400  000
      1992                   300  000                300  000
      1993                                           200  000
                           1 500 000               1 500 000
7.2  Community share of financing
     The Community generally limits its contribution to the work
     of the CEN central secretariat and to about 50% of the work
     of the secretariats of the technical committees involved .
     It should be noted that the Community contribution will be
     reduced if the EFTA countries decide to take part in this
     standardization work .
     Experts involved in standardization work are normally
     expeoted to pay their own expenses .
8.   Observations
     European federations , such as MARCOGAZ , BEUC , AEGPL , AFECI ,
     AFECOGAZ , CEB , CEFACED , EFCEM and UEC will contribute to CEN
     work by submitting contributions to the standardization work
     free of charge .
 ---pagebreak---                                   5
9.    Financial Impact of the activity on the staff
      tratlve appropriations
9.1   Staff required to work on this activity only
      This activity also includes the work of managing the direc¬
      tive on appliances which will require full-time assistance
      from the relevant Commission department ( DG III ).
      For 1989 this work will require :
      one A grade official half time and one expert half time .
9.2 S’ 9.3  Staff and administrative appropriations
      The necessary appropriations are estimated at :
      120 000 ECU a year for an A grade official who will be
      covered by the normal staff appropriations and 90 000 ECU a
      year for an expert remunerated through budget line 7750 .
 ---pagebreak---                 IMPACT ON COMPETITIVENESS AND EMPLOYMENT
 I.   Principal grounds for Introducing the measure
      The appliances sector is an important sector of the European
      economy .
      However , national legislation on appliances differs consid¬
      erably from one Member State to another as regards both
      safety and certification .
      Furthermore , de facto mandatory technical specifications and
      standards , whose observance is in practice a prior condition
      for placing on the market , are often incompatible between
     the various Community countries . This disparity hinders
     trade by creating technical barriers to the free movement of
     goods within the Community , thus preventing the completion
     of the internal market .
     This proposal for a directive aims to ensure the free
     placing on the market and putting into service of appliances
     which satisfy the essential requirements laid down in the
     directive and which are properly certified .
II . Characteristics of the firms concerned . In particular :
     Are many small and medium-sized firms affected ?
     In the appliances sector there are firms of all sizes ,
     including small and medium-sized firms , depending on the
     type of appliance manufactured .
 ---pagebreak---        Are there concentrations in regions
       -   eligible for regional aid from the Member States ?
           No
       -   eligible under the ERDF ?
           No .
III . What obligations,, are imposed directly on firms ?
       From the date of entry into force of this directive , all the
      appliances covered must be so designed and manufactured as
      to satisfy the provisions of the directive . All appliances
      manufactured must bear the CE mart and an EC declaration of
      conformity has to be issued . The EC-conf ormity procedures do
      not differ significantly from those currently in force in
      the Member States .
IV .  ghafr-_ohllgatlQns__inav- be lmpos^d,_lndlrectlY_on_flrms by local
      authorities ?
      The Commission considers that no new obligations will be
      imposed on firms by local authorities after the introduction
      of this directive .
V.    Are there any special measures for small . an<L_m<Bd.iim=si zed
      firms ?
      No .
 ---pagebreak---  VI .   What Is the likely effect ?
        - on firms' competitiveness ?
       The placing on the market of appliances certified as being
       in conformity with the directive and bearing the CE mark
       will be speeded up and will lead to a reduction in costs for
       manufacturers , especially with regard to intra-community
       trade .
       The certification procedures set out in the directive allow
       the manufacturer to choose the most appropriate procedure
       taking into account his manufacturing process . This
       possibility can be of particular interest to small and
      medium-sized enterprises .
      -    on employment ?
      The reduction in costs should lead to a general improvement
      in competitiveness for European manufacturers and hence a
      beneficial effect on the labour market can be expected .
VII . Have employers' and consumers' representatives been
      consulted ?
      Employers' representatives : yes
      Consumers ' representatives : yes
      -   AEGPL , AFECI , AFECOGAZ , CEB , CEFACED , EFCEM and UEC as
          European federations representing the manufacturers ,
          MARCOGAZ as the European federation representing the gas
          producing and supplying industry and BEUC as the European
          federation representing the consumers took an active part
          within the Commission working group of experts contribu¬
          ting directly to the preparation of this proposal for a
          directive .
 ---pagebreak---                                    Proposai for a
                                 Couxioi! Directive
             L!        _ - iimation of the laws of the Kesh.-'- r,j
                ~~2_ ‘_iug to appliances burning gaseous fur.i-
  THB COUNCIL OP THE EUROPEAN COMMUNITIES ,
  Having regard, to the Treaty establishing the European Economic
  Community , and in particular Article 100 a thereof ,
 Having regard to the proposal from the Commission1 ,
  In cooperation with the European Parliament 2
 Having regard to the opinion of the Economic and Social Committee3
 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 , 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 neoessarily lead to different safety levels from one Member
State to another but do , by their disparity , hinder trade within
the Community ;
1   OJ No . C
2   OJ No . C
3   OJ No . C
 ---pagebreak---   Whereas different conditions as regards types of gas and supply
 pressures are in force in the Member States ; whereas these con¬
 ditions are not harmonized because each Member State 's energy
 supply and distribution situation is peculiar to it ;
 Whereas the White Paper on the completion of the internal market ,
 approved by the European Council in June 1985 , provides in
 paragraphs 65 and 68 for a new approach to legislative harmon¬
 ization ;
 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 re¬
 lating to the 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 ;
Whereas the essential health and safety 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 aooount of the state of the art at the time of construction ;
Whereas this Directive therefore contains only mandatory and
essential requirements ; whereas , to facilitate proof of conform¬
ity with the essential requirements , it is necessary to have har ¬
monized standards at European level in particular as to the
design , construction and testing of appliances burning gaseous
fuels so that products complying with them may be assumed to con¬
form to the essential requirements ; whereas these standards , har ¬
monized 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 )
 ---pagebreak---                                        3
  are recognized as the competent bodies for the adoption of harmonized
  standards in accordance with the general guidelines for coopera¬
  tion 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
  the provisions of 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 regulations4 and the above-
 mentioned general guidelines ;
 Whereas , while awaiting the adoption of harmonized standards
 within the meaning of this Directive , conformity with the
 essential requirements and the free movement of appliances burn¬
 ing 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 con¬
 firmed by a Community checking procedure ;
 Whereas a check on compliance with the relevant technical re¬
 quirements 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 certi ¬
fication procedures by the Member States ; whereas , in order to
facilitate mutual recognition of certification procedures , har¬
monized Community procedures should be set up and the criteria
for appointing the bodies responsible for carrying out these pro ¬
cedures should be harmonized ;
4   O.J. n° L 109 , 26.4.1983 , p. 8
 ---pagebreak---                                       4
  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 deoision 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 ) 5 and a separate
  Directive on gas water heaters ( 84 / 5 3 1 / E E C ) 6 ; 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 Deoember 1992 ; whereas the
 internal market consists of an area without internal frontiers
  in which the free movement of goods , persons , services and capital
  isensured ,
HAS ADOPTED THIS DIRECTIVE ;
5   OJ   No  L 300 , 19.11.1984 , p. 95
6   OJ   No  L 300 , 19.11.1984 , p. 106
 ---pagebreak---                                   5
                                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 , refrig¬
    eration , lighting or washing and having , where applicable , an
    operating water temperature not exceeding 105 °C , hereinafter
    referred to as " appliances ".
2.  Appliances specifically designed for use in industrial pro¬
    cesses 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°C
   under a pressure of 1 bar .
4. For the purposes of this      Directive " normally used " appliances
   means
   - when correctly installed , taking especially into consid¬
      eration the type of gas and the supply pressure used in the
      Member State of destination , and
   - when used with the normal variation of the gas quality and
      the normal fluctuation of the supply pressure and when reg¬
      ularly serviced and
   - when used in accordance with its intended purpose or in a
     way which can be reasonably foreseen .
 ---pagebreak---                                    6
                                ΔΕί1θ1&-2
 1.  Member States shall take all necessary steps to ensure that
     the appliances referred to in Article 1 may be plaoed 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 corres ¬
     ponding supply pressures used on their territory to the other
     Member States and the Commission . The latter shall ensure
     that they are published in the Official Journal of the European
    Communi t i es .
                               Artide 3
    Appliances as referred to in Article 1 shall satisfy the rele¬
    vant essential requirements set out in Annex I .
                               Article 4
1.  Member States shall not impede the placing on the market and
    the putting into service of appliances which satisfy the re ¬
    quirements of this Directive .
2.  Member States shall not impede the placing on the market for
    professional use of safety and controlling devices , herein¬
    after referred to as “ devices ", which are designed to be part
    of an appliance and whose characteristics are stated in an
    attestation as referred to in Article 8(4 ).
 ---pagebreak---                              а?;'  е**
                                     Article 5
 1.   Member States shall presume compliance with the relevant
      essential requirements referred to in Article 3 in respect of
      appliances and devices which are designed for incorporation
      in an appliance when conforming to :
     (a)    The relevant national standards implementing the harmo¬
            nized standards , whose reference numbers have been pub¬
            lished in the Official Journal of the European Communi¬
            ties .
           Member States shall publish the reference numbers of the
            said national standards .
    (b)     The relevant national standards 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 re¬
    quirements referred to in Article 3 . The Commission shall
    forward these national standards forthwith to the other Mem¬
    ber States . In accordance with the procedure provided for in
    Article 6(2 ), it shall notify the Member States of those
    national standards in respect of which there is a presumption
    of conformity 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
 ---pagebreak---                                      8
     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 ", giv¬
    ing the reasons therefor . 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
    Artiole 5(1 ).
2.  After receipt of the communication referred to in Article
    6(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 tjuestlon are to enjoy the presumption of con¬
    formity ;         if so , the Member States shall publish the ref¬
   erence number(s ) of that ( those ) standard(s ). 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 CE mark might compromise the safety of persons ,
   domestic animals or property , it shall take all           appropri ¬
   ate 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 :
 ---pagebreak---                              •• 9- 9 -
      (a ) failure to meet the essential requirements referred to
           in Article 3 , where the standards referred to in Article
           5(1 ) have not been applied ;
     (b )  incorrect application of the standards referred to in
           Article 5(1 );
     (c)   shortcomings in the applied standards referred to in
           Artiole 5(1 ) themselves .
 2.  The Commission shall enter into consultation with the parties
     concerned as soon as possible . Where , after such consult¬
     ation , 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 action and the other Member
     States .
    Where the decision referred to in paragraph 1 is attributed
    to shortcomings in the standards , the Commission , after con¬
    sulting 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 CE 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 this procedure .
 ---pagebreak---                                       10
                                   CHAPTER II
                      MEANS OF ATTESTATION OF CONFORMITY
                                   Articles
 1.      The means of attestation of conformity of series-manufactured
         appliances shall be :
  ( a ) at the design level
         - the EC-type examination as referred to in Annex 11(1 )
         and
 ( b ) prior to their being placed on the market , at the Choice Of the
        manufacturer ,
        - the EC declaration of production conformity ( type 1 )
           referred to in Annex 11(2 ) or
        - the EC declaration of production conformity ( type 2 )
           referred to in Annex 11(3 ) or
        - the EC verification ( type 1 ) referred to in Annex 11(4 ).
2.      The means of attestation of conformity in the case of pro ¬
        duction of an appliance as a single unit shall be the EC
        verification ( type 2 ) referred to in Annex 11(5 ).
3.      After completion of the procedures referred to in paragraphs
        1(b ) and 2 the CE marb of conformity shall be affixed to
        conforming applianoes in accordance with Article 10 .
 ---pagebreak---                                        11
 4.   The procedures referred to in paragraph 1 shall he applied in
     respect of devices as referred to in Article 4(2 ) which are
     designed to be part of an appliance . However , no CE mark of
     conformity shall be affixed to the device ; instead an attesta¬
     tion shall be Issued stating its characteristics .
     The attestation shall accompany the device .
 5.  Where the appliances are also          subject to other Community
     Di recti ves .
        the appliances shall be Checked to ensure compliance with the
         requirements of this Directive in accordance with the procedures stated
         in paragraphs 1 and 2 and
     - it shall be ensured that the appliances also comply with
        the requirements Of the Other Directives in accordance with the
        relevant procedures in those Directives .
    The affixing of the CE mark as referred to in paragraph 3 shall
    attest that the provisions of all relevant Directives are
    satisfied .
6.   Records and correspondence relating to the means 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 accepted by the notified
    body concerned .
                                   Article 9
1.  Each Member State shall communicate to the other Member
    States and to the Commission the notified bodies responsible
    for oarrying out the procedures referred to in Article 8 .
 ---pagebreak---                                   12
   The Commission shall publish 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
   the evaluation of the bodies to be notified .
   Bodies which satisfy the criteria for evaluation set out
   in the relevant harmonized standards shall be presumed to be
   in conformity with 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 cri ¬
   teria referred to in paragraph 2 . It shall immediately inform
   the other Member States and the Commission accordingly .
 ---pagebreak---                                  13 -
                              CHAPTER III
                        CE HARK OF CONFORMITY
                              Article 1Q
1.   The CE mark of conformity and the inscriptions as 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 applianoes of marks which are likely to be
    confused with the CE mark shall be prohibited .
                              Article 11
    Where it is established that the CE mark has been wrongly
    affixed to appliances or that the attestation for devices has
   been wrongly attributed because :
    - the appliances or the devices do not conform to the appli ¬
       ance or the devioe as referred to in the EC type approval
       certificate ,
   - the appliances or the devices conform to the appliance or
       the device as referred to in the EC type approval certi ¬
      ficate but which 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 CE
   mark or to issue the attestation and shall so inform the other noti ¬
   fied bodies and report to the Member State concerned .
 ---pagebreak---                                               14
                                         CHAPTER IV
                                    FINAL PROVISIONS
                                        Article 12
      Any decision taken pursuant to this Directive which results
      in restrictions on the placing on the market and / or putting
      into service of an appliance shall state the precise grounds on
      which it is based .         Such a decision 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 January 1991 Member States shall adopt and publish ■
     the laws , regulations and administrative provisions necessary
     in order to comply with this Directive . They shall inform the
     Commission thereof .
     They shall apply such provisions from 31 December 1992 .
2.   Member States shall communicate to the Commission the texts
     of the provisions of national law which they adopt in the
     field OOVered by this Directive .
 ---pagebreak---                                 15
                             Article 15
This  Directive is addressed to the Member States .
Done at Brussels
                                                For the Council
                                                The President
 ---pagebreak---                                      16
                                                                ANNEX I
 1.     ESSENTIAL REÇUTREMENTS
 1 . 1 General conditions
 1.1.1 An appliance shall he 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 manufact ¬
          urer '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 destination .
1.1.3 A device intended to be part of an appliance shall be so
         designed and built as to operate correotly for its intended
         purpose , when incorporated in accordance with the device
         manufacturer 's instructions .
         The instructions for installation , adjustment , operation
         and maintenance shall be provided with the device .
 ---pagebreak---                                    17
 1.2 Materials
 1.2.1 Materials shall be appropriate for their intended purpose
         and shall withstand the mechanical , chemioal 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 manufac¬
         turer 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 .
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 .
 ---pagebreak---                                     18
  1.3 . 1.6   Where electricity is used with a nominal value outside
              the ranges of 50 to 1000 V in the case of alternating
             current and 75 to 1500 V in the case of continuous cur ¬
             rent , the appliance shall also be so designed and con¬
             structed as to avoid electrical hazards .
 1.3 . 1.7   Pressurized parts of an appliance shall withstand , with¬
             out 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 situ¬
             ation .
 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 applianoe 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 accumulation of unburned gas in the appliance
 ---pagebreak---                                      19
  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 un¬
              acceptable 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 .
 ---pagebreak---                                   20
1.3 . 6 . 2 The surface temperatures of knobs and handles of appli ¬
            ances intended to be manipulated shall not reach values
            which present a danger to the user .
1.3 . 6 . 3 The surface temperatures of external parts of an appli ¬
            ance intended for domestio 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 appli ¬
     ance , which may come into contact with food or water used for
     sanitary purposes , shall not impair their quality .
 ---pagebreak---                                 21
                                                             ANNEX II
              PROCEDURES FOR ATTESTATION OF 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 estab¬
       lished 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 noti¬
      fied 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 text
      programme .
 ---pagebreak---                                   22
        The type may additionally oover variants of the type pro ¬
        vided that those variants do not have different character ¬
        istics with respect to safety and efficiency .
 1.3    The notified body shall :
 1.3.1 examine the design documentation and verify that the type
        has been manufactured in conformity with the design docu¬
       mentation and identify the elements whioh have been
       designed in accordance with the relevant provisions of the
       standards and the elements which have been designed in
       aooordance with the essential requirements of the direc¬
       tive .
1.3.2 perform or have performed the appropriate examination
       and / or tests to oheck 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 ohosen to do
       so , thereby assuring conformity with the essential require ¬
       ments . 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 oarried out on the sole basis of the design document ¬
      ation .
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 con¬
      clusions 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 schemes shall be annexed to the certificate .
 ---pagebreak---                                23
1.5  The notified body shall inform the other notified bodies
     forthwith of the issuing of the EC-type approval certifi ¬
     cate 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 oopy of the annexes to the certificate and the
     reports on the examinations and tests oarried out .
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 modifica¬
    tions 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 certi¬
    ficate .
 ---pagebreak---                                   24
 2.   EC DECLARATION OF PRODUCTION CONFORMITY (Type 1 )
 2.1 The EC declaration of produotion 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 manu¬
     facturer 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 oonformity 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 manufacturer , shall carry out random checks on the
    appliances as set out in either paragraph 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 iden¬
           tifiable batches consisting of units of a single model
           which are manufactured under essentially the same con¬
           ditions . At random intervals a batch shall be examined
           to determine conformity by applying a sampling plan with
           the following operating characteristics :
 ---pagebreak---                                  25
         - 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 , correspond¬
           ing to a 5% probability of acceptance with a percent ¬
           age 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 oonformity 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 suoh measures taken .
 ---pagebreak---                                   26
 3.    EC DECLARATION OF PRODUCTION CONFORMITY (Type 2 )
 3.1 The EC declaration of production conformity ( type 2 ) is the
       procedure whereby the manufacturer who satisfies the
       obligations of paragraph 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 .
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 paragraph 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 documentation of the
           approved type
 ---pagebreak---                                   27
      - 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 particu¬
        lar , 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 pro¬
       duct 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 paragraph 3.3.2 . It shall presume conformity
       with these requirements in respect of quality systems that
       implement the corresponding harmonized standard .
 ---pagebreak---                                  28
        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 technologies 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 surveillanoe
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 information , 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---                                  29
4.    EC VERIFICATION (Type 1 )
4 . 1 The EG verification is that part of the procedure whereby a
      notified body ohecks 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 con¬
      formity .
      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 con¬
      formity of the appliance with the relevant requirements of
      the directive .
 ---pagebreak---                                   30
3.     EG VERIFICATION ( Type 2 )
5.1 The EC verification is a procedure whereby a notified body
      cheoks 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 oonformity .
      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 .
 ---pagebreak---                                31
                                                       ANNEX III
                    CE MASK AND 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 identifioation symbol of the notified body that has
   oarried out the random oheoks , the EC surveillanoe 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 identifioation symbol
   - the trade name of the applianoe
   - the eleotrical supply used , if applicable
   - the appliance category .
   Additional information needed for installation shall be added
   according to the nature of the different appliances .
 ---pagebreak---                                 32
                                                      ANNEX IV
                        DESIGN DOCUMENTATION
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 understand¬
      ing 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 stan¬
      dards referred to in Article 5 have not been applied
    - test reports
    - the manuals for installation and for the user .
 ---pagebreak---                                  33
                                                        АШШХ V
         MINIMUM CRITERIA FOR EVALUATION 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 oompetenoe and professional integrity of person¬
       nel ,
     - 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 oircles , 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 1st and 2nd indent shall be
verified at intervals by the competent authorities of the Member
State or by bodies designated by the Member State .