CELEX: 51988PC0780
Language: en
Date: 1988-12-22
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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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                                   COM(88 ) 780 final - SYN 174
                                                   Brussels , 22 December 1988
                       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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 ---pagebreak---                                  EXPLANATORY MEMORANDUM
                    concerning the proposal for a Council directive
                on the approximation of the laws of the Member States
                     relating to non-automatic 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
                                                                                 г
 ---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 used
    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 general
        on International Recommendations , prepared for this purpose by the
        Organisation Internationale de M6trologle L6gale ( OIML ), of which they are
        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/ EEC ) which
        provides for optional harmonization . This directive does not cover
        electronic instruments and modification to deal with the progress In
        technology has become necessary .
                                                                                    3
 ---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 -
I I . THE PROPOSAL
1 . The field of application
      It Is a particular characteristic of legal metrology that It depends upon an
      Instrument 's appl Icat 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 .
                                                                                       3
 ---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
                                                                                   b
 ---pagebreak---                                          - 6 -
    thoughts on conformity assessment as presented In paragraph 2.1 two
    conformity assessment procedures are foreseen :
       I)   Type examination , followed by verification
     II )   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 examinât 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 .
                                                                                   4
 ---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 .
                                                                                 X
 ---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 100A 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 Committee2 ,
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 , !n each Member State , mandatory provisions fix In particular the
necessary performance requirements of non-automatic 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
                                                                                3
 ---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
corresponding national provisions ;
Whereas this Directive contains therefore 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-mandatary texts ;
 ---pagebreak---                                         - 3 -
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 purpose 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 regulations4 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
part les ;
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 Instruments , 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
carried out ;
 4 OJ No L 109 . 26.04.1983 , p. 8 .
                                                                                 АЛ
 ---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 - Application field , placing on the market , free movement
                                         Article 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
    r '.:;u ! res *' . Vcrventlon 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 . It Indicates mass values .
                                                                                   ΑΖ.
 ---pagebreak---                                          - 5 -
    This directive applies to all non-automatic weighing Instruments , hereafter
     referred to as 'Instruments' .
2.   For the purpose of 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 of paragraph 2(a ) of this article .
                                      Art Icle 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 . In case
    the Instrument Is realized 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 .
                                                                                     Ai
 ---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 that comply 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
    Communi ties .
    Member States shall publish the references of the national standards ,
    referred to In paragraph 1 .
                                                                                  Λ
 ---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 ,
hereafter referred to as " the Committee ", giving the reasons for It . 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 , paragraphs 2-4 , do not meet the provisions
    of this directive when properjy 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 .
 ---pagebreak---                                         - 8 -
2.  The Commission shall enter Into consultation with the parties concerned as
    soon as possible .
    After such consultation the Commission shall Immediately Inform the Member
    State that took the action of the result , if the Commission finds that the
    measure Is Justified it shall Immediately inform the other Member States as
    well .
     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 that has taken the measures Intends to maintain them , and
    shall   initiate the procedures referred to in article S.
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 I 1 - Conformity assessment
                                     Article 8
1.  For the purpose of this directive 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 .
                                                                                Àb
 ---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 of this article .
     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.  The Instruments referred to In paragraph 2 of this article , 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 referred to In paragraph 3 of this article that have been
    subject to the EC type examination or that have been exempt 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 of this article .
                                                                                  Aï
 ---pagebreak---                                         - 10 -
Manufactura of non-standard Instruments
7.    Instruments to be used for any of the applications referred to In article
     1.2(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
    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 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 these 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 will, be 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 .
 ---pagebreak---                                            11
 3 . A Member State that has designated a body shall annul the designation 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 and withdraw the notification .
Chapter III - 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 . T'ne affixing to Instruments of marks which are likely to be confused with the
     CE mark of conformity shall be prohibited .
                                       Article 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 It
- 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 .
                                                                                  АЯ
 ---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 realized as a system and where this 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 . This Inscription shall be affixed to the devices in a
clearly visible , easily legible and Indelible form .
Chapter IV - Control of Instruments In service
                                       Art lc!e 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-verifled
    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
                                                                                     là
 ---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 foreseen In paragraph 2 It shall apply
    the maximum permissible error limits as specified In annex 1 , paragraph 4.1 .
     In all other cases It shall apply the maximum permissible error limits as
    specified In annex 1 , paragraph 4.2 .
Chapter V - Transition period
                                      Art Icle 14
1 . EEC type approvals according to council directive 73 / 360/ EEC and national
    type approvals , that are valid at the date of 01.07.1992 , shall remain valid
    until the date of their expiration or until 01.07.2002 , whichever date comes
    first . After this 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 01.07.1992 , 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 .
                                                                                   l1
 ---pagebreak---                                            14 -
Chapter VI - Final provisions
                                      Article 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 01.01.1992 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 01.07.1992 .
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 01.07.1992 .
                                      Article 17
This directive Is addressed to the Member States .
Done at                                 For the Council
                                        The President
 ---pagebreak---                                           15 -
                                                                         Annex 1
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 M6trologle L6gale .
METROLOGICAL REQUIREMENTS
1 .  Un I ts 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 .
 ---pagebreak---                                                  16
 2.      Accuracy classes
 2.1 . The following accuracy classes have been defined :
                 I spec I a I
               I I high
             I I I medium
          I I I I  ordì nary
         The specifications of these classes are given In table 1 .
TABLE 1 : Accuracy classes
 1
 1                                                 Mini mum       Max Imum capac I ty        1
                                                                                             1
 1
 1  C 1 ass           Ver 1 f 1 cat Ion scale      capac I ty            ( Max )             1
                                                                                             1
 1
 1                          Interva 1  (θ)          ( Mln )                                  1
                                                                                             1
 1                                                                                           1
 1                                                                                           1
 1
 1                                                 mini mum    mini mum          max Imum   1
                                                                                            1
 1
 1                                                  value       va lue             value    1
                                                                                            1
 1                                                                                          1
 1                                                                                          1
I
1           1         0.001 g     ^ e               100 e     50 000 e               -
                                                                                            1
                                                                                            1
1                                                                                           1
1                                                                                          1
1
1        1 1          0.001 g 4 e       ^ 0.05 g      20 e       100 e       100 000 e     1
                                                                                           1
1
1                     0.1       g ^ e                 50 e     5 000 e       100 000 e     1
                                                                                           1
1                                                                                          1
1                                                                                          1
                                                                                           1
1
1      1 1 1          0.1      g  ^ θ ^ 2 g           20 e       100 e        10 000 e     1
1
                      5        g                      20 e       500 e        10 000 e     1
1
                                  ^ θ                                                      1
1                                                                                         1
1
     1 1 1 1          5        g                      10 e       100 e           1 000 e  1
1                                 ^ e                                                     1
1                                                                                         1
1                                                                                         1
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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 .
                                                                                     If
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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 .   Multi-interval   Instruments
3.3.1 . Instruments with one weighing range may have several partial weighing
        ranges ( multi-interval instruments ).
        Multi-interval Instruments shall not be equipped with an auxiliary
        indlcat ing device .
3.3.2 . Each partial weighing range I of multi-interval Instruments Is defined
        by
        - Its verification scale interval      with        6 1+1  >   β|
        - Its maximum capacity MaXj ,          wi th       Max r  -   Max
        - its minimum capacity Minj ,          wi th       Mini   m
                                                                      Max |_i
                                               and         Min -) -   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 .
                                                                                 zê
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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 : Multi-interval          Instruments
  I - 1,2 , ... r
 I - partial weighing range number
r - total number of partial weighing ranges
 1
 1                                         Mini mum          Max imum capac 1 ty          1
                                                                                          1
 1                                                                                        1
 1                                         capacity                 ( Max i )             1
                                                                                          1
 ¡Class         Ver 1 f icat ion scale      ( Min )                                       1
 1                                                                                        1
 1                  interval ( e )                                                        1
1                                                                                         1
1                                          mini mum      minimum *              maximum   1
1                                                                                         1
1                                          value         value                  value     1
          1   0.001    g ^ β|              100 e-ι     50 000 Θ Ι+1               -
        1 1   0.001    g $ ei^O.05 g        20 e 1      5 000 e l+1           100 000 β |
              0.1                           50 e -|     5 000 e i+1           100 000 β |
                       9^β |
      1 1 1   0.1      g                    20 e !        500 β Ι+1            10 000 β |
    1 1 1 1   5                             10 e 1         50 β|+1              1 000 β |
                       9 ^ «I
* for i-r the corresponding column of table 1 applies , with e replaced by e r
                                                                                          Z-r
 ---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
1
1                                                                                                    I Max l mum          1
1                                                    Load                                            I pormi ss I b t s   i
1                                                                                                    I orror   on        1
1
1                          1                         I                        1                      I £C Initial        1
1
1                          1                         I                        1                      I conform ! ty      !
1            Class 1       1           Class 1       I          Class 1 1 1   1    Cías·  lili       I assessment        1
1                          1                         I                        1                      I                  1
1                          1                         I                        1                     I                   1
!      0        < 50 000 · 1      0            000 • I      0           500 • 1   0 ^m ^       30 s I   t 0.3 e         I
t 30 000  β <m 4200  000 e 1  5 000 • <m 4 20  000 • I    DÜ0 o<,m ^ 2 000  s 1  50 · <m 4   200 s  I   t 1.0 e         1
1200 000 e < m             1 20 000 • <m ¿ 100 000 • I 2 000 •<m 4 10 000   • 1 200 ·    4I 000 ·   I   t 1 .3 e        1
!                          1                         I                        1                     I                   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 .
                                                                                                                            2'
 ---pagebreak---                                           21
7.   Influence quant It les and tlme
7.1 Instruments of classes II , III and INI , 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 :
      5 °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
    serv I ce .
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 .
 ---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
    faul ts .
    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 I I I 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 .
                                                                                  Зо
 ---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 shall 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 .
 ---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 .
1 0 . 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 .
1 1 . Leve I I I ng
      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
      measuring results .
                                                                                   3Z
 ---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 not
     greater than 100 kg : additional requirements
      Instruments for direct selling to the public shall show all 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 .
                                                                                  25
 ---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 . Price label llng 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 .
 ---pagebreak---                                            27 -
1.    EC typo examination                                                  Annex 2
1.1 . Tho 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 direct Ive
                                                                                     if
 ---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 5 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 cert I f Icate .
      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 .
                                                                                  S6
 ---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 .
                                                                                   H
 ---pagebreak---                                         - 30 -
2.3 . Qua I I ty 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 requl rement(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 contain In partlcular an adéquate description of
    - the quality objectives and the organizational structure , responsibilities
       and powers of the management with regard to product quality
                                                                                  if
 ---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 quality system shall so Inform
   the other notified bodies , giving the reasons for the decision .
                                                                                 - •">
 ---pagebreak---                                          - 32 -
2.4 . EC survel I lance
1 . The purpose of EC surveillance Is to make sure that the manufacturer duly
     fulfils the obligations arising out of the approved quality system .
2 . The 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 all necessary Information , in particular
   -   the quallty System documentation
   -   the design documentation
   -   the quality records , such as Inspection reports and test data , calibration
       data , qualification reports of the personnel concerned , etc .
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 .
3 . EC vérification ( type 1 )
1.    The EC verification ( type 1 ) Is the procedure whereby a notified body checks
      and attests that 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 notified body shall affix the CE
      mark to each Instrument and draw up a written certificate of conformity for
      each Instrument . The certificate of conformity 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 conformity with the relevant requirements of
      this d I rect i ve .
                                                                                   40
 ---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 taking Into
                                                                                    H1
 ---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 be 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 5.1 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 all other examinations and
    tests . The second stage 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 one may either use this same procedure In stage
     two or decide to continue in stage two with the EC verification ( type 1 ).
4.   The CE mark shall be affixed to the instrument after completion of stage
     two , together with the Identification symbol of the notified body Involved
     in stage two .
 ---pagebreak---                                      - 35 -
                                                                        Annex 3
Design documentât Ion
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
                                                                                чь
 ---pagebreak---                                        36 -
                                                                       Annex 4
Instruments to be used for the applications referred to In article 1.2(a ),
and instruments to be used for the applications referred to in article 1.2(b )
that have been subjected to the relevant EC conformity assessment procedure ,
shall carry
a ) - the CE mark of conformity as described in paragraph 3
    - the identification symbol(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)   the following 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                            Min ...
     - verification scale interval   in the form               e - ...
     plus , when applicable
     - ser i a 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       II II  II
                                                      T    - + . .
     - maximum subtractive tare effect    II II  II
                                                      T    - - . .
     - tare Interval                      II II  II
                                                      dj “     ..
     - maximum safe load                  II II  II
                                                      L im
     - the special temperature limits     II ■1  II
                                                      ... e C / .
 ---pagebreak---                                           - 37 -
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 .
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 direct I ve .
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 .
                                                                                 ‘H
 ---pagebreak---        39 -
            Annex 6
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 ---pagebreak---                                    FINANCIAL NOTE
                  concerning the proposal for a Council directive
               on the approximation of the laws of the Member States
                   relating to non-automatic 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 .
 ---pagebreak---                                                                              2.
                                  Financial statement
1.  Budget headings
    Article 775        : Community projects concerning the Internal market .
    1.1   Item 7750    : Harmonization of Industrial  laws .
    1.2   Item 7752    s Multiannual 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-automatic weighing
         instruments , with a view to ensuring that the directive Is properly
         Implemented . The European standards will help to make European Industry
         more competitive .
1  O.J. n° C 136 , 4.6.1985
                                                                                 U
 ---pagebreak---                                                                            3.
   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
                                                                              fo
 ---pagebreak---                                                                               4.
6. Financial    Implications for Intervention appropriations
   6.1    Table of commitments and payments :
               European standards ( Item 7752 )
                         !   CE ( Ecu )  !      CP ( Ecu )
                         !
                         !
               1989      !   100 000     l       50 000
                         1
                         1
               1990      Î   100 000     !      100 000
                         1
                         1
               1991      !                       50 000
              Tota I         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. Comment s
   NI I .
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---                                                                              5.
          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-specialist 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
     regulat Ions .
     For mechanical non-automat in 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
     enterprises .
 ---pagebreak---      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 . Ob I l gat Ions
    The present directive requires that non-automatic weighing Instruments used
    for defined applications meet the essential requirements and are subject to
                           I
    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 .
 ---pagebreak---                                        - 3 -
5 . Parties consulted
    The European federation of weighing Instrument manufacturers CECIP ( Comlt6
    europ6en 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 .