CELEX: 51988PC0780R(01)
Language: en
Date: 1989-02-10
Title: Proposal for a COUNCIL DIRECTIVE on the harmonization of the laws of the Member States relating to non-automatic weighing instruments (presented by the Commission)

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Vol. 1988/0255
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                                COM(88 ) 780 final - SYN 174
REVISED VERSION                                Brussels , 10   February 1989
                                      Proposai for a
                                    COUNCIL DIRECTIVE
                on the harmonization of the laws of the Member States
                    relating to non-automatic weighing instruments
                             ( presented by the Commission )
 ---pagebreak---                                 EXPLANATORY MEMORANDUM
                   concerning the proposal for a Council directive
               on the approximation of the laws of the Member States
                    relating to non-automat I e weighing instruments
I. GENERAL
1 . Introduction
    The proposed directive Is a harmonization directive , drawn up according to
    the principles of the new approach to technical harmonization as presented by
    the Council in its Resolution of 7 May 1985 . It Is recalled that the
    principles of this new approach are
    -  the elaboration by the directive of essential requirements that the
       product(s ) covered shall meet
    -  the mandating of the European standardizing bodies to prepare harmonized
       standards that meet the essential requirements of the directive
    -  the presumption of conformity that these standards give regarding the
       essential requirements of the directive
    -  the voluntary character of the harmonized standards .
    Furthermore new approach directives on technical harmonization are as a
    general rule of total character . The need for the total character follows on
    the one hand from the fact that the product requirements specified are
    regarded as essential and must therefore be met by all products on the
 ---pagebreak---                                             2
    market , and on the other hand from the Commission 's objective to use
    technical harmonization as a means for establishing a global level of safety
    or consumer / user protection that should exist throughout the Community and
    free circulation .
    The directive applies to all non-automatic weighing Instruments that are use
     In application fields that are traditionally subject to legal control by the
    Member States .
2 . Justification
    1 . Member States base their rules In the domain of legal metrology In genera
        on International Recommendations , prepared for this purpose by the
        Organisation Internationale de M6trologle Legate ( 0 1 ML ) , of which they ar
        all members . The existing International Recommendation on non-automatic
        weighing Instruments has been overtaken by the rapid technological
        developments , mainly in the field of electronics . Consequently , OIML has
        been preparing a new International Recommendation , Including electronic
        weighing Instruments . This document Is close to being accepted .
        The Commission 's policy has always been to base Its harmonization
        directives In the field of legal metrology too on OIML International
        Recommendation , whenever possible . This is true for the one existing
        directive on non-automatic weighing Instruments ( 73 / 360/ EECj which
        provides for optional harmonization . This directive does not cover
        electronic Instruments and modification to deal with the progress In
        technology has become necessary .
 ---pagebreak---                                           - 3 -
    2 . A directive according to the new approach requires that the products that
        are covered by It form a homogeneous category of products , as It Is
        otherwise not possible to establish essential requirements that are
        sufficiently precise to enable conformity assessment , to serve as the
        basis for the elaboration of harmonized standards and to form a basis for
        legal action , If necessary , all of which are demanded by the Resolution .
    3 . In line with the preceding the proposed directive Is drawn up according to
        the new approach , Is of total character and covers all non-automatic
        weighing Instruments , Including In particular electronic Instruments .
3 . Relation with the Resolution on the new approach to technical harmonization
    and horizontal documents
    The proposed directive applies the principles of the Resolution strictly and
    follows the structure that Is presented In annex II of the Resolution .
    Since the publication of the Resolution the Commission is developing a policy
    on conformity assessment to complement and clarify the Resolution In that
    respect . A horizontal document has been elaborated that is currently being
    discussed with the Member States .
    The document contains an annex with modules for the conformity assessment
    procedures that are foreseen for technical harmonization directives . The
    present proposal for a directive uses the relevant modules In Its annex on
    conformity assessment procedures ( annex 2 ).
 ---pagebreak---                                                4
II . THE PROPOSAL
1 . The fleld of application
     It is a particular characteristic of legal metrology that It depends upon an
     Instrument 's app I I cat Ion whether or not technical regulations apply . In line
    with this characteristic the directive makes distinction between :
    a ) those categories of application for which only Instruments may be used
        that
        - satisfy the essential requirements specified by the directive and
        - have been subject to EC conformity assessment .
        These instruments shall carry the CE mark of conformity .
    b ) all categories of application other than those under a ). Instruments to be
        used for any of these other applications shall be manufactured in
        accordance with sound engineering practice and shall not carry the CE mark
        of conformity .
    All Instruments that satisfy the provisions of the directive that apply to
    them , whether used for applications of category a ) or category b ), circulate
    freely .
    The categories of application falling under a ) are :
    1 . usage for an application whereby a payment Is to be made the value of
        which depends upon the result of the weighing operation .
    2 . usage for law enforcement purposes and expert opinion .
    3 . usage In the medical practice for weighing patients for reasons of health
        monitoring , diagnosis and treatment .
 ---pagebreak---                                         - 5 -
2 . Conformity assessment
2.1    General considérations
       The policy on conformity assessment to complement the new approach to
       technical harmonization contains the following main elements :
       1.  Limitation of third party Intervention by allowing production control
           by the manufacturer on the basis of an approved quality assurance
           system as an alternative to product control by a third party .
       2.  Limitation of Intervention by public authorities by permitting the
           execution of third party tasks by notified private bodies .
       3.  The provision In the directives of alternative conformity assessment
           procedures that are considered equivalent , and the free choice by the
           manufacturer of the procedure to be used .
       4.  The Introduction of one , single Community mark of conformity which
           Indicates conformity with the essential requirements of the directive .
2.2    The proposed directive on non-automatic weighing Instruments
1 . Conformity assessment Is required for the Instruments that are used for any
    of the applications of category a ), which are the Instruments that shall
    satisfy the essential requirements . In line with the Commission 's current
 ---pagebreak---                                          - 6 -
    thoughts on conformity assessment as presented in paragraph 2.1 two
    conformity assessment procedures are foreseen :
       I)   Type examination , followed by verification
     il )   Type examination , followed by a declaration of production conformity
            of type 2 .
    Of these , type examination followed by verification Is the traditional
    procedure in the domain of legal metrology . The declaration of production
    conformity of type 2 Is an alternative to verification .
2 . Type exam I nat Ion
    Both procedures that are foreseen have the type examination In common .
    The EC type examination is the procedure whereby a third party (a notified
    body ) ascertains that a type of the Instrument ( l.e . an Instrument that is
    representative of the production envisaged ) meets the provisions of the
    directive and issues a type approval certificate .
3 . Vérification
    Verification , In combination with type examination , constitutes the classical
    conformity assessment procedure In legal metrology . In the verification step
    a third party (a notified body ) checks and attests that each Individual
    Instrument concerned Is In conformity with the approved type and satisfies
    the requirements of the directive that apply to It . The notified body affixes
    the CE mark of conformity to each Instrument and draws up a written
    certificate of conformity .
 ---pagebreak---                                         - 7 -
4 . Declaration of production conformity , type 2
    The declaration of production conformity of type 2 is provided as an
    alternative to the verification . Under this procedure the manufacturer Is
    obliged to have Implemented an approved ( by a notified body ) quality
    assurance system that satisfies the requirements of the European standard EN
    29002 or equivalent requirements , supplemented by all necessary product -
    specific requirements . This type of quality assurance system enables the
    assessment , at the level of the Individual instruments , of the conformity
    with the approved type .
    Under this procedure the manufacturer declares that the Instruments concerned
    are In conformity with the type as described In the type approval certificate
    and satisfy the requirements of the directive that apply to them . The
    manufacturer affixes the CE mark to each Instrument and draws up a written
    declaration of conformity for each Instrument .
 ---pagebreak---                           Proposal for a Council Directive
               on the harmonization of the laws of the Member States
                   relating to non-automatic weighing Instruments
THE COUNCIL OF 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 Commission 1 ,
 In cooperation with the European Parliament 2 ,
Having regard to the opinion of the Economic and Social Committee 2 ,
Whereas Member States have the responsibility of protecting the public against
 Incorrect results of weighing operations by means of non-automatic weighing
Instruments when used for certain categories of applications ;
Whereas , In each Member State , mandatory provisions fix In particular the
necessary performance requirements of non-automatlc weighing Instruments by
specifying metrological and technical requirements , together with Inspection
procedures before and after taking Into service ;     whereas these mandatory
provisions       do    not     necessarily     lead   to  different    levels
of protection 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                                                                         f
 ---pagebreak--- Whereas the national provisions ensuring such protection must be harmonized In
order to guarantee the free movement of non-automatic weighing Instruments while
ensuring a Justified level of protection In the Community ;
Whereas Community legislation as it stands at present provides that ,
notwithstanding one of the fundamental rules of the Community , namely the free
movement of goods , barriers to Intra-Community movement resulting from
disparities In national laws on the use of products have to be accepted in so
far as the provisions from those national laws are recognized                   as necessary to
ensure that the products concerned meet essential requirements ;
whereas the harmonization of laws In the present case must therefore be confined
to those provisions needed to ensure that non-automatic weighing Instruments
satisfy the essential metrological and performance requirements ;
whereas , because they are essential , these requirements must replace the
correspond Ing national provisions ;
Whereas this Directive should therefore contain only mandatory and essential requirements;
whereas , to facilitate proof of conformity with the essential requirements , It
 Is necessary to have harmonized standards at European level , in particular as to
the metrological , design and construction characteristics , so that Instruments
complying with those harmonized standards may be assumed to conform to the
essential requirements ; whereas these standards , harmonized at European
level , are drawn up by private bodies and must remain non-mandatory texts ;
 ---pagebreak--- whereas for that purpose the European Committee for Standardization ( CEN ) and
the European Committee for Electrotechnical Standardization ( CENELEC ) are
recognized as the competent bodies for the adoption of harmonized standards In
accordance with the general guidelines for cooperation between the Commission
and those two bodies signed on 13 November 1984 ; whereas , for the purposes
 Of this Directive , a harmonized                   standard       is a technical
specification ( European Standard or Harmonized 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 regulations 4 and the above mentioned general guidelines ;
 Whereas assessment of conformity with the relevant metrological and technical
 requirements is necessary to provide effective protection for users and third
parties ; whereas the existing conformity-assessment procedures differ from one
Member State to another ; whereas , to avoid multiple assessments of conformity ,
which are in effect barriers to the free movement of the instrunents, arrangements should be made
for the mutual recognition of conformity-assessment procedures by      the Member States ;
whereas , to facilitate the mutual recognition of conformity-assessment
procedures , harmonized Community procedures should be set up , together with
harmonized criteria for the designation of the bodies responsible for carrying
out tasks pertaining to the conformity assessment procedures ;
Whereas the presence on a non-automatic weighing instrument of the CE mark of
conformity Indicates that It satisfies the provisions of this Directive                     and
therefore makes It unnecessary to repeat the assessments of conformity already
carr led out ;
4 OJ No L 109 , 26.04.1983 , p. 8 .
 ---pagebreak---                                                    4
Whereas the measures aimed at the gradual establishment of the internal market must be adopted by 31 December
1992; whereas the internal market   consists of an area without Internal frontiers
within which the free movement of goods , persons , services and capital                  is
guaranteed ,
HAS ADOPTED THIS DIRECTIVE :
Chapter I - Field of application ; placing on the market ; free movement .
                                             Art icle 1
1 . A weighing instrument Is defined as a self-contained Instrument or a system
    for the determination of the mass of a body by using the action of gravity on
    that body . The value of the mass of the body must be Indicated .
    A system is a set of interconnected devices assembled to carry out a weighing
    task . A self-contained instrument may be part of a larger system .
    A non-automatic weighing Instrument is defined as a weighing instrument that
    requires the Intervention of an operator to perform a mass determination .
    A non-automatic weighing Instrument may additionally indicate and/or print
    values of quantities , directly derived from the mass value of the body .
    A non-automatic measuring instrument for the measurement of mass-related
    quantities or from mass-derived values is a non-automatic weighing Instrument
    as defined above If It uses the action of gravity and If , and only in so far
    as , 1t Indicates mass values .
                                                                                                  11
 ---pagebreak---                                                 5
      This Directive applies to all non-automatic weighing Instruments , hereafter
      referred to as 'Instruments' .
2 . For the purposesof this Directive the following categories of application
      apply :
    ( a ) ( 1 ) commercial transactions ;
          ( 2 ) the determination of a toll , tariff , tax , bonus , penalty , indemnity
                 or similar type of payment ;
           ( 3 ) law enforcement and expert opinion ;
           ( 4 ) health monitoring , diagnosis and treatment of illness and disorders
                 in the medical ( human and veterinary ) practice .
   (b)      All applications other than those set out at ( a ).
                                           Article 2
Member States shall take all necessary steps to ensure that Instruments may be
placed on the market and taken Into service only If , when properly installed and
used for the purposes for which they are Intended , they meet the provisions of
this Directive that apply to them .
                                           Art Icle 3
1 . Instruments to be used for any of the applications referred to In Article
      1(2)(a ) shall satisfy the essential requirements set out In Annex 1 . where
      the Instrument Is constructed as a system , all devices of the system that are
     not Involved In any of the applications referred to In Article 1(2){a ) are
     excluded from this requirement .
                                                                                         12
 ---pagebreak---                                          - 6 -
2 . Instruments not to be used for any of the applications referred to In Article
    1<2)(a ) need not satisfy the essential requirements set out In Annex 1 but may
    do so , If the manufacturer so wishes .
    If they do not satisfy the essential requirements they shall be manufactured
    In accordance with sound engineering practice of one of the Member States .
    If , however , they do satisfy the essential requirements set out In Annex 1
    they may . If the manufacturer so wishes , be subject to the conformity
    assessment as specified in Article 8 .
                                       Article 4
Member States shall not Impede the placing on the market and the taking Into
service of Instruments that meet the provisions of this Directive .
                                       Article 5
1 . Member States shall presume conformity with the essential requirements
    referred to In Article 3 In respect of instruments     complying with the
    relevant national standards Implementing the harmonized standards that meet
    the essential requirements referred to in Article 3 .
2 . The Commission shall publish the references of the harmonized standards ,
    referred to In paragraph 1 , In the Official Journal of the European
    Commun I t I es .
    Member States shall publish the references of the national standards ,
    referred to In paragraph 1 .
 ---pagebreak---                                              7
                                        Article 6
Where a Member State or the Commission considers that the harmonized standards
referred to In Article 5 ( 1 ) do not fully meet the essential requirements referred
to In Article 3 , the Commission or the Member State concerned shall bring the
matter before the Standing Committee set up under Directive 83 / 189 / EEC ,
hereinafter referred to as “ the Committee ", giving the reasons 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 Article 5(2 ).
                                        Article 7
1 . Where a Member State considers that Instruments bearing the CE mark of
      conformity referred to In Annex 2 ( 2 ), ( 3 ) and ( A ), do not meet the provisions
     of this Directive when properly Installed and used for the purposes for which
      they are Intended , It shall take all appropriate measures to withdraw those
      products from the market or to prohibit or restrict their being placed on the
      market .
      The Member State concerned shall Immediately inform the Commission of any
      such measure , indicating the reasons for Its decision , and In particular
      whether non-compliance Is due to :
    ( a ) failure to meet the essential requirements referred to In Article 3 , where
          the instrument does not meet the standards referred to In Article 5(1 );
    (b ) Incorrect application of the standards referred to In Article 5(1 ) ;
    (c ) shortcomings In the standards referred to In Article 5 (1 ) themselves .
                                                                                        14
 ---pagebreak---                                           - 8 -
2 . The Commission shall enter Into consultation with the parties concerned as
    soon as possible .
    rne Commission shall immediately inform the Memoer State concerned of the
    result of such consultation .      If the Commission finds that the
    measure Is Justified It shall Immediately Inform the other Member States .
    If the measure was taken by the Member State on the grounds of assumed
    shortcomings In the standards the Commission , after consulting the parties
    concerned , shall bring the matter before the Committee within two months If
    the Member State concerned intends to maintain the measures , and
    shall Initiate the procedures referred to In Article 6 .
3 . Where an Instrument which does not comply bears the CE mark of conformity ,
    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 .
Chapter 1 1 - Conformity assessment
                                        Art Iele 8
1 . For the purposes of this Directive a distinction is made between manufacture of
    standard Instruments and manufacture of non-standard instruments , manufacture
    of non-standard instruments being unit or limited series manufacture
     involving typically , but not necessarily , custom-designed Instruments ,
    special-purpose Instruments , and the like .
                                                                                    AS
 ---pagebreak---                                            - 9 -
Manufacture of standard instruments
2.   Instruments to be used for any of the applications referred to in Article
    1(2)(a ) shall be subject to the EC type examination referred to In Annex 2(1 ).
3 . Instruments not to be used for any of the applications referred to In Article
    1 (2) (a ) that satisfy the essential requirements set out In Annex 1 may , at the
    choice of the manufacturer , be subject to the EC type examination referred to
    In Annex 2 (1 ).
4 . In either of the cases referred to In paragraphs        2    and    3,
    Instruments not using any electronic device and of which the load measuring
    device does not use any spring to balance the load need not be subject to
    said EC type examination but may , at the choice of the manufacturer , be
    subject to It .
5 . Instruments as       referred  to  in paragraph    2,  including  those
    that have been exempt from the EC type examination on the grounds of the
    provisions of paragraph 4 , shall prior to their being taken Into service be
    subject , at the choice of the manufacturer ;
           either to the EC declaration of production conformity ( type 2 ) referred
           to In Annex 2 (2 ),
           or to the EC verification ( type 1 ) referred to in Annex 2(3 ).
6 . Instruments as referred lo in paragraph 3 . that have, been subject
    to the EC type examination or that have been exempted from it on the grounds of
    the provisions of paragraph 4 may , at the choice of the manufacturer , be
    subject , prior to their being taken Into service , to any of the two
    procedures referred to In paragraph 5 .
                                                                                     16
 ---pagebreak---                                             10 -
Manufacture of non-standard instruments
7 . Instruments to be used for any of the applications referred to In Article
    1C2> ( a ) shall each be subject to the EC verification ( type 2 ), referred to in
    Annex 2 (4 ).
8 . Instruments not to be used for any of the applications referred to In Air 1 1 c I e
    l(2Xa ) that satisfy the essential requirements set out In Annex 1 may , at the
    choice of the manufacturer , be subject to the EC verification ( type 2 ),
    referred to In Annex 2(4 ).
Common provisions
9 . The records and correspondence relating to the procedures referred to in
    paragraphs 2 to 8 shall be drafted in an official language of the Member
    State where said procedures will be carried out , or In a language accepted by
    the responsible body .
                                        Art Icle 9
1 . Member States shall notify to the other Member States and the Commission the
    bodies which they have designated for carrying out tasks pertaining to the
    procedures referred to In Article 8 , the specific tasks for which each body
    has been designated      and the identification codes of the designated bodies .
    The Commission shall publish the list of those notified bodies , together with
    the tasks for which they have been designated , In the Official Journal of the
    European Communities and shall ensure that the list       is  kept     up to date .
2 . Member States shall apply the minimum criteria , set out In Annex 5 , for the
    designation of bodies . Bodies that satisfy the criteria fixed by the relevant
    harmonized standards are presumed to satisfy the criteria set out In Annex 5 .
                                                                                        17
 ---pagebreak---                                            11
3 . A Member State that has designated a body shall withdraw the des Ignat ion If the
    body no longer meets the criteria for designation referred to In paragraph 2 .
     It shall Immediately Inform the other Member States and the Commission
    accordingly .
Chapter til - CE mark of conformity and Inscriptions
                                      Article 10
1 . The CE mark of conformity and the required supplementary data , as described
     In Annex 4 , shall be affixed to the Instruments concerned In a clearly
    visible , easily legible and Indelible form .
2 . The affixing to Instruments of marks which are likely to be confused with the
    CE mark of conformity shall be prohibited .
                                      Art le le 11
Where It Is established that the CE mark of conformity has been wrongly affixed
to Instruments because :
- they do not conform to the relevant standards referred to In Article 5(1 );
- they do not conform to an approved type ;
- they conform to an approved type which does not meet the essential
   requirements applicable to 1 1, or
- the manufacturer has failed to fulfil his obligations under the EC declaration
   of conformity ( type 2 ),
the EC type approval certificate and /or the approval of the quality system , as
the case may be , shall be withdrawn by the competent notified body .
 ---pagebreak---                                              12
                                         Article 12
Where an Instrument that Is to be used for any of the applications referred to
 In Article 1(2)(a ) Is constructed as a system and where that system contains devices
that have not been subject to conformity assessment as referred to In Article 8 ,
each of these devices shall carry the Inscription " not permitted for trade
purposes " in the official languages of the Member State where the Instrument Is
taken Into service . That Inscription shall be affixed to the devices In a
clearly visible , easily legible and Indelible form .
Chapter IV - Control of Instruments In service
                                         Article 13
1 . Instruments that carry the CE mark of conformity and are used for any of the
     applications referred to In Article 1(2)(a ) shall be subject to In-service
      Inspection by a notified body to ensure that they are still in conformity
     with the type as described In the type approval certificate ( if applicable )
      and satisfy the requirements of this Directive that apply to them .
2 . They shall be re-verlfled :
    (a ) after repair , modification , or re-assembly ;
    ( b ) after relocation in a geographical area with a gravity value that Is
          sufficiently different to Justify the re-ver I f icat Ion , In particular of
          the error of indication .
 ---pagebreak---                                            13
 3 . When carrying out these Inspections the notified body shall carry out the
     appropriate tests as set out In the relevant standards referred to In Article
     5 , or equivalent tests . In the cases referred to in paragraph 2 It shall apply
     the max I mum permissible error limits as spec I f led In Annex 1 ( A)(1 ).
     In all other cases it shall apply the maximum permissible error limits as
     specified In Annex 1(4)(2 ).
 Chapter V - Transition period
                                       Article 14
 1 . EEC type approvals pursuant to Council Directive 73/ 360/EEC^ancJ national
     type approvals , that are valid on 1         July      1992,' . shall remain valid
     until the date of their expiration or until 1 July 2002, whichever date is the ear¬
     lier . After that date they shall nevertheless remain In force for the
     Instruments referred to In paragraph 2 .
 2 . Member States shall allow the further use , as from 1 July 1992 , of instruments
     that are legally In service at that date and for as long as they satisfy the
     requirements that are applicable to them on the basis of their type approval
     or their   Initial verification .
50J No L 335. 5.12.1973, p.1 .
                                                                                         20
 ---pagebreak---                                              14
Chapter VI - Final provisions
                                        Art le le 15
Any decision taken pursuant to this Directive and resulting In restrictions on
the taking Into service of an Instrument shall state the exact 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 Judicial 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 16
1 . Before 1 January 1992 Member States shall adopt and publish the laws , regulations
    and administrative provisions necessary In order to comply with this
    Directive . They shall forthwith Inform the Commission thereof .
    They shall apply such provisions from 1 July 1992 .
2 . Member States shall communicate to the Commission the texts of the provisions
    of national law which they adopt In the field covered by this Directive .
3 . Directive 73 / 360 / EEC shall be repealed as from  1 July 1992 .
                                        Article 17
This   Directive  Is addressed to the Member States .
Done at                                   For tt>« Cound I
                                          The President
 ---pagebreak--- The essential requirements that must be met by the Instruments , referred to In
article 1.2(a ), are set out below . The terminology used Is of the Organization
Internationale de MMrologle L6gale .
METROLOGICAL REQUIREMENTS
1 . Units of mass
    The units of mass used shall be legal In the sense of directive
    80/ 181 / EEC 1 .
    Subject to this condition , the following units are permitted :
- of the SI units : kilogramme , microgramme , milligramme , gramme , tonne
- of the Imperial units : pound , ounce ( avoirdupois ), troy ounce
- of the other units : metric carat , If weighing precious stones
For Instruments that make use of the Imperial units of mass referred to above ,
the relevant essential requirements specified hereafter shall be converted to
said Imperial units , using simple Interpolation .
1 OJ n # L 39 of 15.02.1980 , p. 39 .                                         22
 ---pagebreak---                                             - 16 -
2.     Accuracy classes
2.1 . The following accuracy classes have been defined :
              l special
            Il  high
          I I I medium
        IMI     ord Inary
       The specifications of these classes are given In table 1 .
TABLE 1 : Accuracy classes
1
i                                               Mini mum       Max Imum capacity       1
                                                                                       1
1
1   Class          Ver i f I cat Ion sca le     capac I ty            ( Max )          1
                                                                                       1
1
f                       Interva 1    (e)         ( Min )                               1
                                                                                       1
1                                                                                      1
1                                                                                      1
1
I                                               mini mum    mini mum          max Imum 1
                                                                                       1
1
1                                                value       va lue            value   1
                                                                                       1
1                                                                                      1
1                                                                                      1
1
1         1         0.001 g < e                  100 e     50 000 e              -
                                                                                       1
                                                                                       1
1                                                                                      1
1
1       1 1         0.001 g ^ e ^ 0.05 g           20 e       100 e       100 000 e    t
                                                                                       1
1
1                   0.1      g ^ e                 50 e     5 000 e       100 000 e    1
                                                                                       1
                                                                                       1
1                                                                                      1
t
1     1 1 1         0.1      g     e  ( 2g         20 θ       100 e         10 000 e   1
                                                                                       1
I
(                   5        g ^ e                 20 e       500 e         10 000 e   1
                                                                                       1
1                                                                                      I
1
1   1 1 1 1         5        g ^ e                 10 e       100 e           1 000 e  1
                                                                                       1
1                                                                                      1
1                                                                                      1
                                                                                         23
 ---pagebreak---                                            17 -
2.2 . Scale Intervals
      1 . The actual scale Interval ( d ) and the verification scale Interval ( e )
          shall be In the form
          1 x 10* , 2 x 10*. or 5 x 10* mass units ,
          k being any Integer or zero .
      2 . For all Instruments other than those with auxiliary Indicating devices ,
          d Is equal to e .
      3 . For Instruments with auxiliary Indicating devices the following
          conditions apply :
          e - 1 x 10*g
          d < e $-10 d
          except for Instruments of class I with d<10~4 g , for which
          e - 10~3 g .
3.        Classification
3.1 .     Instruments with one weighing range
3.1.1 .   Instruments without an auxiliary Indicating device may belong to any of
          the four accuracy classes defined .
3.1.2 .   Instruments equipped with an auxiliary Indicating device shall belong to
          class I or class II .  For these Instruments the minimum capacity lower
          limits for these two classes are obtained from table I by replacement In
          column 3 of the verification scale interval ( e ) by the actual scale
          Interval ( d ).
          If d < 10~4 g , the maximum capacity of class I may be less than
          50 000 e .
                                                                                    24
 ---pagebreak---                                           - 18 -
3.1.3 .  In case an Instrument meets the specifications of more than one accuracy
        class , the choice of class Is left to the manufacturer .      The Instrument
        shall meet all requirements of this directive for the class chosen .
3.2 .    Instruments with multiple weighing ranges
        Multiple weighing ranges are permitted , provided they are clearly
         Indicated on the Instrument .     Each Individual weighing range Is
        classified according to 3.1 . If the weighing ranges fall into different
        accuracy classes the Instrument shall comply with the severest of the
        requirements that apply for the accuracy classes In which the weighing
        ranges fall .
3.3 .   Mu 1 1 l-lnterva I Instruments
3.3.1 . Instruments with one weighing range may have several partial weighing
        ranges ( multi-interval Instruments ).
        Mul t l-lnterva I Instruments shall not be equipped with an auxiliary
        Indlcat ing device .
3.3.2 . Each partial weighing range I of mult l-interva I Instruments Is defined
        by
        - its    verification scale Interval e¡ , with         ®l+1  >   ®1
        - its    maximum capacity Max | ,          with        Max r     Max
        - its    minimum capacity Mini ,           with        Mln t -
                                                                         Max |_i
                                                   and         Mlnj  "   Min
        where I - 1.2 . r
                 I - partial weighing range number
                 r ® the total number of partial weighing ranges .
        All capacities are capacities of net load . Irrespective of the value of
        any tare used .
                                                                                      25
 ---pagebreak---                                                 19 -
3.3.3    The partial weighing ranges are classified according to table 2 . All
         partial weighing ranges shall fall into the same accuracy class , this
         class being the Instrument 's accuracy class .
TABLE 2 : Mu 1 1 1 - 1 nter va I Instruments
I - 1,2 , ... r
I - partial weighing range number
r - total number of partial weighing ranges
                                          Mini mum         Max imum capac I ty
                                          capac I ty              ( Max ,)
 Class       Vérification scale            ( Min )
                 Interval ( e )
                                          mini mum     minimum *             max imum
                                          value        value                 value
       1   0.001    8 ^ e,                100 e 1    50 000 β Ι+1
     1 1   0.001    8 ^ β | <0.05 g        20 Oj      5 000 β Ι+1          100 000 «I
           0.1      8 ζ β.                 50 βι      5 000 β Ι+1          100 000 β |
   1 1 1   0.1      9 ^ «I                 20 ej        500 β|+1            10 000  β|
  II 1 1   5        8 ^ β.                 10 ΟΊ         50 β|+1             1 000 β |
* for l-r the corresponding column of table 1 applies , with e replaced by er
                                                                                       21
 ---pagebreak---                                                                    - 20 -
         4.      Accuracy
         4.1 On EC Initial conformity assessment the error of indication shall not exceed
                 the maximum permissible error of Indication as shown In table 3 . In case of
                 digital Indication the error of indication shall be corrected for the
                 rounding error .
                 The maximum permissible errors apply to the net and tare value for all
                 possible loads , excluded preset tare values .
         TABLE 3 : Maximum permissible errors
I                                                                                                                 1 Max i mum       1
I                                                         Lood                                                    1 pftrmiftftlblft 1
I                                                                                                                 1 • rror  on      1
I                           I                             I                            1                          1 EC Initial      1
I                           I                             I                            1                          1 conformity      1
I            Clot » I       I           C I at· I 1       I            C 1 ott 1 1 1   1     C 1 Oft· II 1 1      1                 1
I                           I                             I                            1                          1                 1
I                           I                             I                            1                          1                 1
I       0   ¿»¿ 50    000 · I      0            5 000 a   I      0    <m <       500 • 1   0          <      50 • 1   t o.s ·       1
I 50 000 ·<ικ<.200 000 · I     5 000 • <m ^ 20      000 • I    500  • «« <: 2 000    a 1  50  • <« é       2°°  • 1   ft 1.0 ·      1
I 200 000 · <.»»            I 20 000     tn ^ 100   000 • I 2 000   • <IB ^ 10 000   • 1 200  • < m^1 000       • 1   t  1.5 ·      1
I                           I                             I                            1                          1                 1
         4.2 The maximum permissible errors In service are twice the maximum permissible
                 errors on EC Initial conformity assessment .
         5.      Weighing results of an instrument shall be repeatable , and shall be
                 reproducible among Indicating devices used and methods of balancing used .
                 The weighing results shall be sufficiently Insensitive to changes In the
                 position of the load on the load receptor .
         6.      The instrument shall react to small variations of the load .
                                                                                                                                      27
 ---pagebreak---                                        - 21
7.  Influence quant It les and tlme
7.1 Instruments of classes II , III and Mil , liable to be used In tilted
    position , shall be sufficiently Insensitive to the degree of tilting that
    can exist In normal   Installed condition .
7.2 The Instruments shall meet the metrological requirements within the
    temperature range specified by the manufacturer . The value of this range
    shall be at least equal to :
     S °C for an Instrument of class I ,
    15 *C for an Instrument of class II ,
    30 °C for an Instrument of class III or INI .
    In the absence of a manufacturer 's specification , the temperature range of
    -10°C to +40°C appl les .
7.3 Instruments operated from a mains power supply shall meet the metrological
    requirements under conditions of power supply within the limits of normal
    f luctuat Ion .
    Instruments operated from battery power shall Indicate whenever the voltage
    drops below the minimum required value and shall under those circumstances
    either continue to function correctly or be automatically put out of
    service .
7.4 Electronic Instruments , except those of class I and of class II If e Is less
    than 1 g , shall meet the metrological requirements under conditions of high
    relative humidity at the upper limit of their temperature range .
7.5 Loading an Instrument of class II , III or INI for a prolonged period of
    time shall have a negligible Influence on the Indication at load or on the
    zero Indication Immediately after removal of the load .
                                                                                 2Î
 ---pagebreak---                                         22 -
7.6 Under other conditions the Instruments shall either continue to function
    correctly or be automatically put out of service .
DESIGN AND CONSTRUCTION
8.  General requlrements
8.1 Design and construction of the Instruments shall be such that the
    Instruments will preserve their metrological qualities when properly used
    and Installed , and when used In an environment for which they are Intended .
8.2 When exposed to disturbances electronic Instruments shall not display
    significant faults , or shall automatically detect and act upon significant
    faults .
    Upon automatic detection of a significant fault electronic instruments shall
    provide a visual or audible alarm that shall continue until the user takes
    corrective action or the fault disappears .
8.3 The requirements of 8.1 and 8.2 shall be met on a lasting basis . Electronic
    Instruments shall therefore not display significant durability errors during
    a period of time that is normal In view of the Intended use of the
    Instruments , or shall automatically detect and act upon significant
    durab 1 1 1 ty errors .
    Digital electronic devices shall always exercise adequate control of the
    operation of the measuring process , of the Indicating facility , and of all
    data storage and data transfer .
 ---pagebreak---                                        - 23 -
    Upon automatic detection of a significant durability error electronic
     Instruments shall provide a visual or audible alarm that shall continue
    until the user takes corrective action or the error disappears .
8.4 When external equipment Is connected to an electronic Instrument through an
    appropriate Interface the metrological qualities of the Instrument shall not
    be adversely Influenced .
8.5 The Instruments shall have no characteristics likely to facilitate
    fraudulent use , whereas possibilities for unintentional misuse snail be
    minimal . Components that may not be dismantled or adjusted by the user shall
    be secured against such actions .
8.6 Instruments shall be designed to permit ready execution of the statutory
    controls foreseen by this directive .
9.  Indication of weighing results and other weight values
    The Indication of the weighing results and other weight values shall be
    accurate , unambiguous and non-misleading and the Indicating device shall
    permit easy reading of the Indication under normal conditions of use .
    The names and symbols of the units referred to In point 1 of this annex
    shall be according to the dispositions of directive 80/ 181 / EEC1 , with the
    addition of the symbol for the metric carat which shall be the symbol * ct‘ .
    Indication shall be Impossible above the maximum capacity ( Max ), Increased
    by 9 e .
1  OJ n * L 39 of 15.02.1980 , p. 39 .                                            30
 ---pagebreak---                                           24 -
     An auxiliary Indicating device is permitted only behind the decimal mark . An
     extended Indicating device may be used only temporarily , and printing shall
     be Inhibited during its functioning .
     Secondary Indications may be shown , If Identified such that they can not be
     mistaken for primary Indications .
10 . Printing of weighing results and other weight values
     Printed results shall be correct , suitably Identified and unambiguous . The
     printing shall be clear , legible , non-erasable and durable .
11 . Level I Ing
     When appropriate Instruments shall be fitted with a levelling device and a
     level indicator , sufficiently sensitive to allow proper Installation .
12 . Zerolng
     The Instruments may be equipped with zeroing devices . The operation of these
     devices shall result in accurate zeroing and shall not cause incorrect
     measur ing results .
                                                                                31
 ---pagebreak---                                         - 25 -
13 . Tare devlces and preset tare devlces
     The instruments may have one or more tare devices and a preset tare device .
     The operation of the tare devices shall result In accurately setting the
     Indication to zero and shall ensure correct net weighing . The operation of
     the preset tare device shall ensure correct determination of the calculated
     net value .
14 . Instruments for direct selling to the public with a maximum capacity no t
     greater than 100 kg : additional requirements
     Instruments for direct selling to the public shall show al ! essential
     Information about the weighing operation and , In the case of price
     Indicating instruments , of the price calculation of the product to be
     purchased , clearly to the customer .
     The price to pay , If Indicated , shall be accurate .
     Price computing Instruments shall show the essential Indications for long
     enough to enable the customer to read them properly .
     Price computing instruments may perform functions other than per article
     weighing and price computation only If all Indications related to all
     transactions shall be printed clearly , unambiguously and conveniently
     arranged on a ticket or label for the customer .
     The Instruments shall bear no characteristics that can cause , directly or
     Indirectly , indications whose Interpretation Is not easy or straightforward .
     The Instruments shall safeguard the customers against Incorrect sales
     transactions due to malfunctioning of the Instruments .
                                                                                  32
 ---pagebreak---                                            26 -
       Auxiliary Indicating devices and extended Indicating devices are not
       permitted .
       Supplementary devices are only permitted If and such that they do not enable
$     fraudulent use by the vendor , unbeknown to the customer .
       Instruments with the characteristics of those used for direct selling to the
       public , which however do not meet the requirements described In this
       paragraph shall carry the Indelible marking ‘Not to be used for direct
       selling to the public *. This marking shall be clearly visible on the side of
       the instrument normally facing the customer If It were to be used for direct
       selling to the pub I ic .
  15 . Pr I ce labe I I Ing Instruments
       Price labelling Instruments shall meet the requirements of price Indicating
       Instruments for direct selling to the public , as far as applicable to the
       instrument In question . The printing of a price label shall be Impossible
       below minimum capacity .
                                                                                    33
 ---pagebreak---                                          - 27 -
1.    EC type examinat Ion                                                 Annex 2
1.1 . The EC type examination Is the procedure by means of which a notified body
      ascertains and certifies that an Instrument , representative of the
      production envisaged , meets the provisions of this 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 .
      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 3 .
      The applicant shall place at the disposal of the notified body an
      Instrument , representative of the production envisaged and hereafter called
      • type *.
1.3 . The notified body shall
      1 . examine the design documentation , verify that the type has been
            manufactured In conformity with this design documentation , and identify
            the elements that have been designed In accordance with the relevant
            provisions of the standards and essential requirements referred to In
            this directive
                                                                                     3-
 ---pagebreak---                                            28 -
      2 . perform or have performed the appropriate examinations and /or tests to
          check whether the solutions adopted by the manufacturer meet the
          essential requirements where the standards referred to In article S have
          not been appl led
      3 . perform or have performed the appropriate examinations and/or tests to
          check whether , where the manufacturer has chosen to apply the relevant
          standards , these have been applied effectively , thereby assuring
          conformity with the essential requirements
      4 . agree with the applicant the location where the examinations and/or
          tests shall be carried out .
1.4 . Where the type meets the provisions of this directive the notified body
      shall Issue an EC type approval certificate to the applicant . The
      certificate shall contain the conclusions of the examination , conditions
      ( If any ) for Its validity , the necessary data for identification of the
      approved Instrument and , If relevant , a description of its functioning . The
      relevant technical elements such as drawings and schemes shall be annexed
      to the certificate .
      The certificate shall have a validity period of 10 years from the date of
      its Issue , and may be renewed for subsequent periods of 10 years each .
1.5 . The other notified bodies shall be Informed forthwith of the issuing of the
      EC type approval certificate for the said type and Its additions referred
      to In paragraph 1.7 . They may obtain a copy of the EC type approval
      certificate 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 .
                                                                                   35
 ---pagebreak---                                          29 -
1.6 . A notified body that refuses to Issue or withdraws an EC type approval
      certificate or any of Its additions referred to In paragraph 1.7 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 any modification to the approved type .
      Modifications to the approved type must receive additional approval from
      the notified body that Issued the EC type approval certificate where such
      changes Influence the conformity with the essential requirements of this
      directive or the prescribed conditions for use of the Instrument . This
      additional approval Is given In the form of an addition to the original EC
      type approval certificate .
2.    EC declaration of production conformity ( type 2 )
2.1 . The EC declaration of production conformity ( type 2 ) Is the procedure
      whereby the manufacturer who satisfies the obligations of paragraph 2.2
      declares that the Instruments 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 Instrument and shall draw
      up a written declaration of conformity for each Instrument .
      The CE mark shall be accompanied by the Identification symbol of the
      notified body responsible for the EC surveillance referred to In paragraph
      2.2 . The certificate of conformity shall accompany the Instrument covered .
2.2 . The manufacturer shall have adequately Implemented a quality system as
      specified In paragraph 2.3 and shall be subject to EC surveillance as
      specified In paragraph 2.4 .
                                                                                3(
 ---pagebreak---                                         - 30 -
2.3 . Quai Ity System
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 's documentation
       and the design documentation 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 .
2 . The quality system shall ensure compliance of the Instruments with the type
     as described in the EC type approval certificate and with the requirement ( s )
     of this directive that apply to them .
     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 conta in In partlcular an adéquate description of
     - the qualify objectives and the organizational structure , responsibilities
       and powers of the management with regard to product quality
                                                                                37
 ---pagebreak---                                         - 31
    -   the manufacturing process , and the 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 . The notified body shall examine and evaluate the quality system to determine
    whether It satisfies the requirements referred to In paragraph 2.3.2 . 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 .
4 . The manufacturer or his authorized representative 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 .
5 . A notified body that withdraws approval of a qualify system shall so Inform
    the other notified bodies , giving the reasons for the decision .
 ---pagebreak---                                           - 32 -
2.4 . EC survel ! lance
1 . Th® purpose of EC surveillance is to make sure that the manufacturer duly
     fulfils the obligations arising out of the approved quality system .
2 . Th® manufacturer shall allow the notified body entrance for Inspection
     purposes to the locations of manufacture , inspection and testing , and
     storage , and shall provide it with ali necessary information , in particular
   -     the quallty System documentation
   -     th© design documentation
   -     the quality records , such as inspection reports and test data , calibration
         data , qualification reports of th® personnel concerned , etc .
3 . Th© notified body shall make sure that th® manufacturer maintains and applies
     th© quality system and shall provide a surveillance report to the
     manufacturer .
3 . EC vérification ( type 1 )
1 . The EC verification { type 1 ) is th© procedure whereby a notified body checks
     and attests that Instruments concerned are In conformity with the type as
     described In th® EC type approval cortlfieat® and satisfy the requirements of
     this directive that apply to them . Th® notified body shall affix th® CE mark
     to each Instrument and draw up a written certificate of conformity for each
     Instrument . The cert If Icate of conformity shall accompany the Instrument
     covered .
2 . Each instrument shall ba examined and appropriate tests as set out In the
     relevant standards referred to In article 5 , or equivalent tests , shall bs
     carried out to ensure their conformity with the relevant requirements of this
     d l reet ! v® .
                                                                                    39
 ---pagebreak---                                         - 33 -
    3 . The CE mark referred to In paragraph 1 above shall be accompanied by the
        Identification symbol of the notified body .
4 . EC vérification ( type 2 )
1 . The EC verification ( type 2 ) Is the procedure whereby a notified body checks
    and attests that the Instruments concerned satisfy the requirements of this
    directive that apply to them . The notified body shall affix the CE mark to
    each Instrument and shall draw up a written certificate of conformity for
    each Instrument .
    The certificate shall have a validity period of 10 years from the date of Its
    Issue , and may be renewed for subsequent periods of 10 years each . It shall
    accompany the Instrument covered .
2 . Each instrument 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 to ensure their compliance with the relevant requirements of this
    direct Ive .
3 . The CE mark referred to in paragraph 1 above shall be accompanied by the
    Identification symbol of the notified body .
4 . The design documentation of the instrument as specified In annex 3 shall be
    made available to the notified body .
5 . Common provisions
1 . The EC declaration of production conformity ( type 2 ), the EC verification
    ( type 1 ), and the EC verification ( type 2 ) may be carried out at the
    manufacturer 's works or any other location If the transport to the place of
    use does not require dismantling of the Instrument . If the talcing Into
 ---pagebreak---                                         - 34 -
    service at the place of use does not require assembly of the instrument or
    other technical Installation work likely to affect the Instrument 's
    performance , and if the instrument 's performance is Insensitive to gravity
    variations . In all other cases they shall foe carried out at the place of use
    of the instrument .
2 . if the instrument 's performance Is sensitive to gravity variations the
    procedures referred to in paragraph S.1 may be carried out in two stages ,
    where the second stage shall comprise all examinations and tests of which the
    outcome is gravity dependant , and the first stage ail other examinations and -
    tests . The second stag® shall be carried out at the place of use of the
    instrument . In case a Member State has established gravity zones on Its
    territory the expression 'at the place of use of the instrument' may be read
    as 'In the gravity zone of use of the Instrument *.
3.1 . Where a manufacturer has opted for execution In two stages of one of the
    procedures mentioned in paragraph 5.1 , and where these two stages will be
    carried out by different parties , an instrument that has undergone the first
    stage of the procedure concerned shall carry the identification symbol of the
    notified body Involved in that stage .
2 . The party that has carried out the first stage of the procedure shall Issue
    for each of the Instruments a certificate , containing the necessary data for
    Identification of the Instrument and specifying the examinations and tests
    that have been carried out .
    The party that carries out stage two of the procedure shall carry out those
    examinations and tests that have not yet been carried out .
3 . The manufacturer who has opted for the EC declaration of production
    conformity ( type 2 ) in stage on© may either use this same procedure In stage
    two or decide to continue In stage two with the EC verification ( type 1 ).
4 . The €S marie shall be affixed to the Instrument after completion of stage two ,
    together with the Identification symbol of the notified body Involved In
    stage two .
                                                                                  41
 ---pagebreak---                                      - 35 -
                                                                       Annex 3
Design documentation
The design documentation shall contain In so far as relevant for assessment :
- a general description of the type
- 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 product
-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
- results of design calculations made and of examinations etc
- test reports
                                                                                 A r
 ---pagebreak---                                             - 36 -
                                                                              Annex 4
1 . Instruments to be used for the applications referred to In article 1.2(a ),
    and Instruments to foe ur.sd for the applications referred to In article 1.2(b )
    that have been subjected to the relevant EC conformity assessment procedure .
    sha 1 1 carry
    a ) - the CE mark of conformity as described In paragraph 3
        -- the Identification symbo I ( s ) of the notified body(les ) that has/ have
           carried out the EC surveillance or the EC verification
           The above mentioned mark and Inscriptions shall be affixed to the
           Instrument , distinctly grouped together .
    b)    tha followlng Inscriptions :
          - manufacturer ‘s mark or name
          - the accuracy class , enclosed In an oval or In two horizontal lines
            joined by two half circles
          - maximum capacity In the form                              Max ...
          - minimum capacity In the form                              Mln ...
          - verification scale interval      In the form              e - ...
          plus , vihen applicable
          - ser la I number
          - for instruments consisting of separate but associated units :
             Identification mark on each unit
          - scale Interval                       In the form  d   -   ...
          - maximum additive tare effect          "  “   "    T   - + ...
          - maximum subtractive tare effect       "  "   ”    T   » - ...
          – tare Intervat                         “  “   "    dT «
          - maximum safe load                     “  “   "    Llm
          - the special temperature limits               "    ... °C / ... °C
                                                                                      43
 ---pagebreak--- 2 . Instruments to be used for the applications referred to In article 1.2(b )
    that have not been subjected to the relevant EC conformity assessment
    procedure shall carry
    -    the manufacturer 's mark or name
    -    the maximum capacity In the form                    Max ...
3 . The CE mark of conformity shall consist of the symbol CE as shown In annex 6 ,
    followed by the last two digits of the year in which It was affixed .
4 . The Instruments shall have adequate facilities for the affixing of the CE
    mark of conformity and /or inscriptions . These shall be such that It shall be
    Impossible to remove the mark and Inscriptions without damaging them , and
    that the mark and Inscriptions shall be visible when the Instrument Is In Its
    regular operating position .
5 . Where a data plate Is used It shall be possible to seal the plate unless It
    cannot be removed without being destroyed . If the data plate Is sealable It
    shall be possible to apply a control mark to It .
6 . The inscriptions Max . Min . e , d , shall also be shown near the display of the
    result If they are not already located there .
7 . Each load measuring device which Is connected or can be connected to one or
    more load receptors shall bear the relevant Inscriptions relating to said
     load receptors .
 ---pagebreak---                                        - 38 -
                                                                         Annex 5
Set out below are the minimum criteria to be applied by Member States when
designating bodies for the carrying out of tasks pertaining to the procedures
referred to In article 8 .
1 . The bodies shall dispose of the necessary personnel , means and equipment .   1
2 . The personnel shall have technical competence and professional Integrity .
3 . The staff and personnel shall be Independent of all circles , groups or
    persons having direct or Indirect Interest In non-automatic weighing
    Instruments regarding the carrying out of the tests , the preparation of the
    reports , the issuing of the certificates and the surveillance requested by
    this directive .
4 . The personnel shall respect the professional secret .
5 . The bodies shall have taken out a civil liability Insurance If their civil
     liability Is not covered by the State under national law .
The fulfilment of the conditions under 1 . and 2 . shall be periodically verified
by the Member States .
                                                                                 45
 ---pagebreak--- 39 -
     Am.ex 6
                 /
             À
              1
                '0
 ---pagebreak---                                      FINANCIAL NOTE
                  concerning the proposal for a Council directive
               on the appros imat Ion of the laws of the Member States
                   relating to non-automat le weighing Instruments
Introduct Ion
The proposal for a directive relating to non-automatic weighing Instruments lays
down the essential requirements that must be satisfied by the Instruments In
question . Article 5 of the proposal makes a general reference to European
standards . Instruments manufactured In compliance with such standards are
presumed to be In conformity with the essential requirements of the directive .
Given the absence of European standards In the non-automatic weighing
instruments sector , the Commission must request the CEN to fill that gap .
The Commission Intends to contribute to the development of European
standardization by entrusting the CEN with the task of drawing up the necessary
standards In the non-automatic weighing Instruments sector In accordance with
the general guidelines for cooperation between the Commission , the CEN and
CENELEC , which were approved on 13 November 1984 . The work will be carried out
on the basis of standardization requests transmitted to the CEN In pursuance of
the framework contracts signed on 10 October 1985 , which provide for financial
support by the Commission .
The standardization work described above , which will be of limited duration ,
must be placed against the general background of the administration of the
directive , which Is a long-term activity .
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                                  Financial statement
1.  Budget headlngs
    Article 775        : Community projects concerning the Internal market .
    1.1   Item 7750    : Harmonization of Industrial  laws .
    1.2   Item 7752    : Multlannual measures to strengthen European standardizing
                         bodies .
2.  Legal basis
    2.1  Council Resolution of 7 May 1985 on a new approach to technical
         harmonization and standards 1 .
    2.2  Directive to be adopted by the Council on the approximation of the laws
         of the Member States relating to non-automatic weighing Instruments .
3.  Proposed classification
    Non compulsory expenditure .
4.  Description and Justification of the project
    4.1  Objectives
         The aim Is to assist with the drafting of European standards that will
         meet the basic requirements of the directive on non-sutcmst Ic weighing
          Instruments , with a view to ensuring that the directive is properly
          Implemented . The European standards will help to make European Industry
         more compet It Ive .
1  O.J. n° C 136 , 4.6.1S85
                                                                                   /i
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   4.2  Staff
        Apart from management of the directive , the proposed activities are
        short-term and highly technical . The Commission does not have staff
        qualified to deal with the technical aspects of the project .
5. Nature of the outlay and method of calculation
   5.1  Nature
        The project will take the form of standardization mandates , given on
        the basis of the existing framework contract of 10 October 1985 between
        the Commission and CEN / CENELEC .
   5.2  Calculation
        The level of financing will be determined for each mandate taking Into
        account the work to be carried out by contractors .
        Estimate of the appropriations ( cost per unit x number of units )
        European standards
        50 000 x 4
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6. Financial   Implications for Intervention appropriations
   6.1   Table of commitments and payments :
             European standards ( Item 7752 )
                            CE ( Ecu )  I     CP ( ECU )
             1989           100 000    !       50 000
             1990           100 000    ¡      100 000
             1991                              50 000
             Total          200 000    ¡      200 000
   6.2   Community share of the financing
         The Community share of the financing will cover 100% of the required
         expenses .
7. Comments
   Nil .
8. Financial Implications for staff and administrative appropriations
   8.1   Staff required exclusively for the execution of the project
         This project Involves management of the directive on non-automatic
         weighing Instruments , which will call for the participation of the
         Commission staff over a period of several years .
 ---pagebreak---           As from 1989 one A grade official will be required to work on the
          project for three months a year and one B grade official to work half
          time .
8.2 & 8.3   Staff and administrative appropriations
          It is estimated that appropriations of 75 000 ECU per year will be
          necessary .
 ---pagebreak---                          IMPACT ON COMPETITIVENESS AND EMPLOYMENT
                     concerning the proposal for a Council directive
                  on the approximation of the laws of the Member States
                      relating to non-automatic weighing Instruments
1 . Principal Justification of the proposed directive
    Non-automatic weighing Instruments , like many other measuring Instruments
    that find large-scale , non-spec I a 1 1 st application In society ( usually , but
    not exclusively , in commercial transactions ) are subject to legal control by
    Member States for reasons of fair trading or for otherwise protecting the
    parties that are Involved In a weighing operation .
    The national regulations for electronic non-automatic weighing Instruments
    differ from one Member State to another and approvals are not mutually
    recognized . Consequently , a manufacturer who wishes to place an Instrument on
    the market in all of the Member States of the Community must seek approval In
    each Member State and , as the case may be , manufacture different versions of
    his product In order to cope with the differences In the national
    regu I at ions .
    For mechanical non-automatic weighing Instruments a directive ( 73 / 360 ) was
    adopted In 1973 .
    The proposed directive will harmonize the national regulations for all non-
    automatic weighing Instruments ( l.e . mechanical and electronic ) and hence
    ensure the free movement of products that are covered by It and that meet the
    requirements that apply to them .
2 . Characteristics of the sector
    The European weighing machine Industry employs over 22,000 people In more
    than 400 firms . Of these the vast majority are small or medium sized
    enterpr I ses .
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    The sector which was by and large mechanical In the past has come to depend
    more and more on electronic techniques and products . Competition Is stiff .
    Exports have been declining over the last years , with imports Increasing at
    an average rate of 10% per year .
3 . Obi Igat Ions
    The present directive requires that non-automatic weighing instruments used
    for defined applications meet the essential requirements and are subject to
    conformity assessment according to procedures given by it . These applications
    and procedures are similar to those laid down In directive 73 / 360 , and
    therefore this proposal will entail very little extra administrative or
    financial cost .
    No obligations by the Member States , other than those following from the
    transposition Into national   law of the directive , are foreseen .
4 . Competitiveness and employment
    The harmonization of the national regulations Is expected to lead to a
    reduction In cost and to an increase In efficiency . Although third country
    manufacturers will share the same benefits , the European manufacturers have
    the opportunity to Increase their competitiveness from which a positive
    effect on employment could be expected .
    As a matter of fact , In order to ensure free movement for their products
    manufacturers now need to submit their products to a conformity assessment
    procedure In one of the Member States only . This Is expected to lead to a
    reduction of the costs , as well as of the time delay involved in obtaining
    approval and will hence give the manufacturer the opportunity to place his
    products on the market faster and cheaper .
    A new , alternative conformity assessment procedure permits the manufacturer
    to declare the conformity of his product with the approved type himself and
    to affix the CE mark of conformity to the product himself .
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5. Part les consu I ted
   The European federation of weighing Instrument manufacturers CECIP ( Comlt6
   europden des Constructeurs d' Instruments de Pesage ) has been a most active
   participant In the meetings of the Working Group that have resulted In the
   current proposal and are In agreement with the essential elements of the
   proposa I .
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