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

No C 55/6                              Official Journal of the European Communities                                   4. 3. 89
                                                              II
                                                       (Preparatory Acts)
                                                 COMMISSION
              Proposal for a Council Directive on the harmonization of the laws of the Member States
                                       relating to non-automatic weighing instruments
                                               COM(88)    780 final — SYN 174
                                      (Submitted by the Commission on 3 January 1989)
                                                         (89/C 55/05)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                           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;
Having regard to the Treaty establishing the European              whereas the harmonization of laws in the present case
Economic Community, and in particular Article 100A                 must therefore be confined to those provisions needed to
thereof,                                                           ensure that non-automatic weighing instruments satisfy
                                                                   the essential metrological and performance requirements;
                                                                   whereas, because they are essential, these requirements
Having regard to the proposal from the Commission,
                                                                   must replace the corresponding national provisions;
In cooperation with the European Parliament,
                                                                   Whereas this Directive should therefore contain only
Having regard to the opinion of the Economic and                   mandatory and essential requirements; whereas, to
Social Committee,                                                  facilitate proof of conformity with the essential
                                                                   requirements, it is necessary to have harmonized
                                                                   standards at European level, in particular as to the
Whereas Member States have the responsibility of                   metrological, design and construction characteristics, so
protecting the public against incorrect results of                 that instruments complying with those harmonized
weighing operations by means of non-automatic                      standards may be assumed to conform to the essential
weighing instruments when used for certain categories of           requirements; whereas these standards, harmonized at
applications;                                                      European level, are drawn up by private bodies and must
                                                                   remain non-mandatory texts;
Whereas, in each Member State, mandatory provisions
fix in particular the necessary performance requirements
of non-automatic weighing instruments by specifying                Whereas for that purpose the European Committee for
metrological and technical requirements, together with             Standardization (CEN) and the European Committee
inspection procedures before and after taking into                 for Electrotechnical Standardization (Cenelec) are
service; whereas these mandatory provisions do not                 recognized as the competent bodies for the adoption of
necessarily lead to different levels of protection from one        harmonized standards in accordance with the general
Member State to another but do, by their disparity,                guidelines for cooperation between the Commission and
hinder trade within the Community;                                 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
Whereas the national provisions ensuring such protection           harmonized document) adopted by one or both of those
must be harmonized in order to guarantee the free                  bodies upon a remit from the Commission in accordance
movement of non-automatic weighing instruments while               with the provisions of Council Directive 83/189/EEC of
ensuring a justified level of protection in the                    28 March 1983 laying down a procedure for the
Community;                                                         provision of information in the field of technical
                                                                   standards and regulations (') and the abovementioned
                                                                   general guidelines;
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           (') OJ No L 109, 26. 4. 1983, p. 8.
 ---pagebreak--- 4. 3. 89                               Official Journal of the European Communities                               No C 55/7
Whereas assessment of conformity with the relevant               'A non-automatic weighing instrument' may additionally
metrological and technical requirements is necessary to          indicate and/or print values of quantities, directly
provide effective protection for users and third parties;        derived from the mass value of the body.
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,         'A non-automatic measuring instrument for the
arrangements should be made for the mutual recognition           measurement of mass-related quantities or from mass-
of conformity-assessment procedures by the Member                derived values' is a non-automatic weighing instrument
States; whereas, to facilitate the mutual recognition            as defined above if it uses the action of gravity and if,
of     conformity-assessment      procedures,    harmonized      and only in so far as, it indicates mass values.
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;                                This Directive applies to all non-automatic weighing
                                                                 instruments, hereafter referred to as 'instruments'.
Whereas the presence on a non-automatic weighing
instrument of the CE mark of conformity indicates that           2.     For the purposes of this Directive, the following
it satisfies the provisions of this Directive and therefore      categories of application apply:
makes it unnecessary to repeat the assessments of
conformity already carried out;
                                                                  (a) (1) commercial transactions,
                                                                      (2) the determination of a toll, tariff, tax, bonus,
Whereas the measures aimed at the gradual estab-                           penalty, indemnity or similar type of payment,
lishment of the internal market must be adopted by
31 December 1992; whereas the internal market consists                (3) law enforcement and expert opinion,
of an area without internal frontiers within which the                (4) health monitoring, diagnosis and treatment of
free movement of goods, persons, services and capital is                   illness and disorders in the medical (human and
guaranteed,                                                                veterinary) practice;
HAS ADOPTED THIS DIRECTIVE:                                       (b) all applications other than those set out at (a).
                         CHAPTER I                                                          Article 2
                                                                 Member States shall take all necessary steps to ensure
Field of application; placing on the market;            free
                                                                 that instruments may be placed on the market and taken
                          movement
                                                                 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.
                           Article 1
 1.    'A weighing instrument' is defined as a self-
contained instrument or a system for the determination                                      Article 3
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              1.    Instruments to be used for any of the applications
indicated.                                                       referred to in Article 1 (2) (a) shall satisfy the essential
                                                                 requirements set out in Annex I. 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
  A system' is a set of interconnected devices assembled to      Article 1 (2) (a) are excluded from this requirement.
carry out a weighing task. A self-contained instrument
may be part of a larger system.
                                                                 2.     Instruments not to be used for any of the
'A non-automatic weighing instrument' is defined as a            applications referred to in Article 1 (2) (a) need not
weighing instrument that requires the intervention of an         satisfy the essential requirements set out in Annex I but
operator to perform a mass determination.                        may do so, if the manufacturer so wishes.
 ---pagebreak--- No C 55/8                              Official Journal of the European Communities                                   4. 3. 89
If they do not satisfy the essential requirements they shall     The Member State concerned shall immediately inform
be manufactured in accordance with sound engineering             the Commission of any such measure, indicating the
practice of one of the Member States. If, however, they          reasons for its decision and, in particular, whether
do satisfy the essential requirements set out in Annex I         non-compliance is due to:
they may, if the manufacturer so wishes, be subject to
the conformity assessment as specified in Article 8.              (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);
                          Article 4
                                                                  (b) incorrect application of the standards referred to in
Member States shall not impede the placing on the                     Article 5 (1);
market and the taking into service of instruments that
meet the provisions of this Directive.                            (c) shortcomings in the standards referred to in Article 5
                                                                      (1) themselves.
                          Article 5                               2.    The Commission shall enter into consultation with
                                                                  the parties concerned as soon as possible.
 1.    Member States shall presume conformity with the
essential requirements referred to in Article 3 in respect        The Commission shall immediately inform the Member
of instruments complying with the relevant national               State concerned of the result of such consultation. If the
standards implementing the harmonized standards that              Commission finds that the measure is justified it shall
meet the essential requirements referred to in Article 3.         immediately inform the other Member States.
                                                                  If the measure was taken by the Member State on the
2.     The Commission shall publish the references of the         grounds of assumed shortcomings in the standards the
harmonized standards, referred to in paragraph 1, in the          Commission, after consulting the parties concerned, shall
 Official Journal of the European Communities.                    bring the matter before the Committee within two
                                                                  months if the Member State concerned intends to
                                                                  maintain the measures, and shall initiate the procedures
Member States shall publish the references           of the       referred to in Article 6.
national standards, referred to in paragraph 1.
                                                                  3.    Where an Instrument which does not comply bears
                                                                  the CE mark of conformity, the competent Member
                          Article 6                               State shall take appropriate action against whomsoever
                                                                  has affixed the mark and shall inform the Commission
Where a Member State or the Commission considers                  and the other Member States thereof.
that the harmonized standards referred to in Article 5(1)
 do not fully meet the essential requirements referred to
                                                                  4.    The Commission shall ensure that the Member
 in Article 3, the Commission or the Member State
                                                                  States are kept informed of the progress and outcome of
 concerned shall bring the matter before the Standing
                                                                  this procedure.
 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.                                                                          CHAPTER II
                                                                                     Conformity assessment
 In the light of the Committee's opinion, the Commission
 shall inform the Member States whether or not it                                           Article 8
 is necessary to withdraw those standards from the
                                                                   1.   For the purposes of this Directive, a distinction is
publications referred to in Article 5 (2).
                                                                  made between manufacture of standard instruments and
                                                                  manufacture of non-standard instruments, manufacture
                                                                  of non-standard instruments being unit or limited series
                          Article 7                               manufacture involving typically, but not necessarily,
                                                                  custom-designed instruments, special-purpose instru-
 1.    Where a Member State considers that instruments            ments, and the like.
 bearing the CE mark of conformity referred to in Annex
 I (2), (3) and (4) do not meet the provisions of this
 Directive when properly installed and used for the               Manufacture of standard instruments
purposes for which they are intended, it shall take all
 appropriate measures to withdraw those products from             2.    Instruments to be used for any of the applications
the market or to prohibit or restrict their being placed on       referred to in Article 1 (2) (a) shall be subject to the EC
the market.                                                       type-examination referred to in Annex II (1).
 ---pagebreak---  4. 3. 89                               Official Journal of the European Communities                               No C 55/9
 3.    Instruments not to be used for any of the                   The Commission shall publish the list of those notified
 applications referred to in Article 1 (2) (a) that satisfy        bodies, together with the tasks for which they have been
 the essential requirements set out in Annex I may, at the         designated, in the Official Journal of the European
 choice of the manufacturer, be subject to the EC type-             Communities and shall ensure that the list is kept up to
 examination referred to in Annex II (1).                          date.
 4.    In either of the cases referred to in paragraphs 2
 and 3, instruments not using any electronic device and of         2.     Member States shall apply the minimum criteria, set
which the load measuring device does not use any spring            out in Annex V, for the designation of bodies. Bodies
to balance the load need not be subject to said EC type-           that satisfy the criteria fixed by the relevant harmonized
examination but may, at the choice of the manufacturer,            standards are presumed to satisfy the criteria set out in
be subject to it.                                                  Annex V.
5.     Instruments as referred to in paragraph 2, including
                                                                   3.    A Member State that has designated a body shall
those that have been exempt from the EC type-exam-
                                                                   withdraw the designation if the body no longer meets the
ination on the grounds of the provisions of paragraph 4,
                                                                   criteria for designation referred to in paragraph 2. It
shall prior to their being taken into service be subject, at
                                                                   shall immediately inform the other Member States and
the choice of the manufacturer:                                    the Commission accordingly.
— either to the EC declaration of production
     conformity (type 2) referred to in Annex II (2),
                                                                                           CHAPTER III
— or to the EC verification (type 1) referred to in
    Annex II (3).                                                           CE mark of conformity and inscriptions
6.     Instruments as referred to in paragraph 3 that have
been subject to the EC type-examination or that have                                         Article 10
been exempted from it on the grounds of the provisions
of paragraph 4 may, at the choice of the manufacturer,             1.    The CE mark of conformity and the required
be subject, prior to their being taken into service, to any        supplementary data, as described in Annex IV, shall be
of the two procedures referred to in paragraph 5.                  affixed to the instruments concerned in a clearly visible,
                                                                   easily legible and indelible form.
Manufacture of non-standard instruments
                                                                   2.    The affixing to instruments of marks which are
7.     Instruments to be used for any of the applications          likely to be confused with the CE mark of conformity
referred to in Article 1 (2) (a) shall each be subject to the     shall be prohibited.
EC verification (type 2), referred to in Annex II (4).
8.     Instruments not to be used for any of the                                             Article 11
applications referred to in Article 1 (2) (a) that satisfy
the essential requirements set out in Annex I may, at the         Where it is established that the CE mark of conformity
choice of the manufacturer, be subject to the EC verifi-          has been wrongly affixed to instruments because:
cation (type 2), referred to in Annex II (4).
                                                                  — they do not conform to the relevant              standards
Common provisions                                                      referred to in Article 5(1),
9.    The records and correspondence relating to the
                                                                  — they do not conform to an approved type,
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                — they conform to an approved type which does not
language accepted by the responsible body.                             meet the essential requirements applicable to it, or
                          Article 9
                                                                  — the manufacturer has failed to fulfil his obligations
1.    Member States shall notify to the other Member                   under the EC declaration of conformity (type 2),
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       the EC type-approval certificate and/or the approval of
which each body has been designated and the identifi-             the quality system, as the case may be, shall be
cation codes of the designated bodies.                            withdrawn by the competent notified body.
 ---pagebreak--- No C 55/10                            Official Journal of the European Communities                                  4. 3. 89
                         Article 12                                                     CHAPTER V
Where an instrument that is to be used for any of the                                 Transition period
applications referred to in Article 1 (2) (a) is constructed
as a system and where that system contains devices that                                   Article 14
have not been subject to conformity assessment as                1.    EEC type-approvals pursuant to Council Directive
referred to in Article 8, each of those devices shall carry     73/360/EEC (*) and national type-approvals, that are
the inscription 'not permitted for trade purposes' in the       valid on 1 July 1992, shall remain valid until the date of
official languages of the Member State where the                their expiration or until 1 July 2002, whichever date is
instrument is taken into service. That inscription shall be     the earlier. After that date they shall nevertheless remain
affixed to the devices in a clearly visible, easily legible     in force for the instruments referred to in paragraph 2.
and indelible form.
                                                                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-
                        CHAPTER IV
                                                                approval or their initial verification.
              Control of instruments in service
                                                                                        CHAPTER VI
                                                                                       Final provisions
                         Article 13
                                                                                          Article 15
1.     Instruments that carry the CE mark of conformity
                                                                Any decision taken pursuant to this Directive and
and are used for any of the applications referred to in
                                                                resulting in restrictions on the taking into service of an
Article 1 (2) (a) shall be subject to in-service inspection
                                                                instrument shall state the exact grounds on which it is
by a notified body to ensure that they are still in
                                                                based. Such a decision shall be notified without delay to
conformity with the type as described in the type-
                                                                the party concerned, who shall at the same time be
approval certificate (if applicable) and satisfy the
                                                                informed of the judicial remedies available to him under
requirements of this Directive that apply to them.
                                                                the laws in force in the Member State in question and of
                                                                the time limits to which such remedies are subject.
2.    They shall be re-verified:                                                          Article 16
                                                                 1.    Before 1 January 1992 Member States shall adopt
(a) after repair, modification, or re-assembly;                 and publish the laws, regulations and administrative
                                                                provisions necessary in order to comply with this
                                                                Directive. They shall forthwith inform the Commission
(b) after relocation in a geographical area with a gravity      thereof.
     value that is sufficiently different to justify the        They shall apply such provisions from 1 July 1992.
     re-verification, in particular of the error of indi-
     cation.                                                    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.    When carrying out these inspections the notified          3.     Directive 73/360/EEC is repealed as from 1 July
body shall carry out the appropriate tests as set out in         1992.
the relevant standards referred to in Article 5, or equi-
valent tests. In the cases referred to in paragraph 2 it                                  Article 17
shall apply the maximum permissible error limits as
                                                                This Directive is addressed to the Member States.
specified in Annex I (4) (1). In all other cases it shall
apply the maximum permissible error limits as specified
in Annex I (4) (2).                                             C) OJ No L 335, 5. 12. 1973, p. 1.
 ---pagebreak--- 4. 3. 89                             Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                       - No C 55/11
                                                               ANNEX     I
         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 Metrologie Legale.
                                              METROLOGICAL REQUIREMENTS
         1.     Units of mass
                The units of mass used shall be legal in the sense of Directive 80/181/EEC (').
                Subject to this condition, the following units are permitted:
                — of the SI units: kilogram, microgram, milligram, gram and tonne,
                — of the imperial units: pound, ounce (avoirdupois) and 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.
         2.     Accuracy classes
         2.1.   The following accuracy classes have been defined:
                  I. Special.
                 II. High.
                III. Medium.
                IV. Ordinary.
                The specifications of these classes are given in table 1.
                                                                    TABLE 1
                                                                 Accuracy classes
                                                                     Minimum capacity                    Maximum capacity
                                     Verification scale interval                                              (max)
                      Class
                                                 (e)
                                                                       Minimum value        Minimum value         Maximum value
                         I           0,001 g < e                            100 e              50 000 e                   —
                        II           0,001 g < e < 0,05 g                     20 e                    100 e         100 000 e
                                     0,1 g < e                                50 e                5 000 e           100 000 e
                       III           0,1      g<e<2g                          20 e                    100 e          10 000 e
                                     5       g < e                            20 e                    500 e          10 000 e
                       IV            5        g<e                             10 e                    100 e            1 000 e
         2.2     Scale intervals
         2.2A.  The actual scale interval (d) and the verification scale interval (e) shall be in the form:
                 1 x 10k, 2 x 1 0 k o r 5 x 10k mass units
                k being any integer or zero.
         2.2.2. For all instruments other than those with auxiliary indicating devices, d is equal to e.
         2.2.3. For instruments with auxiliary indicating devices the following conditions apply:
                e = 1 X 10 k g
                d < e < 10 d,
                except for instruments of class 1 with d < 10"4 g, for which e = 10"3 g.
         (') OJ No L 39, 15. 2. 1980, p. 39.
 ---pagebreak--- N o C 55/12                                   Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                          4. 3. 89
            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 II. For these
                   instruments, the minimum capacity lower limits for these two classes are obtained from table 1 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.
            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 paragraph 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 indicating device.
            3.3.2. Each partial weighing range i of multi-interval instruments is defined by:
                   — its verification scale interval e;, with e; +         t > e;
                   — its maximum capacity max;, with max r = max
                   — its minimum capacity min ; , with min; = maxj.j and min t = 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.
            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.
                                                                              Minimum capacity                    Maximum capacity
                         Class               Verification scale interval             (min)                              (max;)
                                                         (e) ~
                                                                                Minimum value      Minimum value (')         Maximum value
                             I               0,001 g < e;                           100    ei        50 000 e ; + !                 —
                            II               0,001 g < ej < 0,05 g                    20 e.            5 000 e ; + ,           100 000 e;
                                             0,1     g < e;                           50 e i           5 000 e i + ,           100 000 e ;
                           III               0,1     g < ei                           20 ei               500 e i   + 1         10 000 e;
                           IV                5       g < e;                           10   ei                50 e i + 1          1 000 e;
                   (') For i = r the corresponding column of table 1 applies, with e replaced by e r .
 ---pagebreak--- 4. 3. 89                                   Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                       No C 55/13
              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
                                                           Load
                                                                                                                              Maximum permissible
                                                                                                                               error on EC initial
           Class I                       Class II                           Class III                          Class IV       conformity assessment
      0   < m <    50 000 e          0   < m <       5 000 e           0   < m <        500 e        0       < m <       50 e        ± 0,5 e
 50 000 e < m < 200 000 e        5 000 e < m <     20 000 e        500 e < m <        2 000 e      50 e < m <           200 e        ± 1,0 e
200 000 e < m                   20 000 e < m < 100 000 e         2 0 0 0 e < m < 10 000 e        200 e < m < 1 000 e                 ± 1,5 e
              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.
              7.     Influence quantities and time
              7.1.   Instruments of classes II, III and IV, liable to be used in tilted position, shall be sufficiently insen-
                     sitive 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 IV.
                    In the absence of a manufacturer's specification, the temperature range of—10 to -I- 40 °C applies.
              7.3.  Instruments operated from a mains power supply shall meet the metrological requirements under
                    conditions of power supply within the limits of normal fluctuation.
                    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.
 ---pagebreak--- N o C 55/14                              Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                4. 3. 89
            7.5.   Loading an instrument of class II, III or IV 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.
            7.6.   Under other conditions the instruments shall either continue to function correctly or be auto-
                   matically put out of service.
                                                      DESIGN AND CONSTRUCTION
            8.     General requirements
            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 paragraphs 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
                   durability 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.
                   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/EEC ('), 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.
                   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.
            (') OJ No L 39, 15. 2. 1980, p. 39.
 ---pagebreak--- 4. 3. 89                           Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                N o C 55/15
         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.  Levelling
             When appropriate instruments shall be fitted with a levelling device and a level indicator,
             sufficiently sensitive to allow proper installation.
         12.  Zeroing
             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.
         13. Tare devices and preset tare devices
             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 malfunc-
             tioning of the instruments.
             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 public.
         15. Price labelling 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--- N o C 55/16                             Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s               4. 3. 89
                                                                 ANNEX      II
            1.     EC type-examination
            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 III.
                   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:
            1.3.1. 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;
            1.3.2. perform or have performed the appropriate examinations and/or tests to check whether the
                   solutions adopted by the manufacturer meet the essential requirements where the standards referred
                   to in Article 5 have not been applied;
            1.3.3. perform or have performed the appropriate examinations and/or tests to check whether, where the
                   manufacturer has chosen to apply the relevant standards, these have been applied effectively,
                   thereby assuring conformity with the essential requirements;
            1.3.4. 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 exam-
                   ination, 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.
            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.
 ---pagebreak--- 4. 3. 89                              Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s              N o C 55/17
                 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.
         2.3.    Quality system
         2.3.1. The manufacturer shall lodge an application for approval of his quality system with a notified body.
                The application shall include:
                — all relevant information, in particular the quality system's documentation and the design docu-
                     mentation of the approved type,
                — an undertaking to carry out the obligations arising from the quality system as approved,
                — an undertaking to maintain the approved quality system to ensure its continuing suitability and
                     effectiveness.
         2.3.2. 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 contain in particular an adequate description of:
                — the quality objectives and the organizational structure, responsibilities and powers of the
                     management with regard to product quality,
                — 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.
         2.3.3. 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.
 ---pagebreak--- N o C 55/18                               Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s              4. 3. 89
                   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.
            2.3.4. 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.
            2.3.5. A notified body that withdraws approval of a quality system shall so inform the other notified
                   bodies, giving the reasons for the decision.
            2.4.    EC surveillance
            2.4.1. The purpose of EC surveillance is to make sure that the manufacturer duly fulfils the obligations
                   arising out of the approved quality system.
            2.4.2. 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 quality system documentation,
                   — the design documentation,
                   — the quality records, such as inspection reports and test data, calibration data, qualification
                        reports of the personnel concerned, etc.
            2.4.3. The notified body shall make sure that the manufacturer maintains and applies the quality system
                   and shall provide a surveillance report to the manufacturer.
            3.     EC verification (type 1)
            3.1.   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.
            3.2.   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 Directive.
            3.3.   The CE mark referred to in paragraph 1 above shall be accompanied by the identification symbol of
                   the notified body.
           4.      EC verification (type 2)
           4.1.    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.
           4.2.    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 Directive.
           4.3.    The CE mark referred to in paragraph 1 above shall be accompanied by the identification symbol of
                   the notified body.
           4.4.    The design documentation of the instrument as specified in Annex III shall be made available to the
                   notified body.
 ---pagebreak--- 4. 3. 89                               Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                   N o C 55/19
         5.       Common provisions
         5.1.     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'
                  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.
         5.2.     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 examin-
                  ations and tests of which the outcome is gravity dependant, and the first stage all other examin-
                  ations 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'.
         5.3.1   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.
         5.3.2. 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.
         5.3.3. 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).
         5.3.4. 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.
                                                               ANNEX      III
                                                   DESIGN D O C U M E N T A T I O N
         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, subassemblies, 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.
 ---pagebreak--- N o C 55/20                             Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                4. 3. 89
                                                                 ANNEX      IV
            1. 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(ies) that has/have carried out the EC
                       surveillance or the EC verification.
               The abovementioned 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:
                   — serial number,
                   — for instruments consisting of separate but associated units: identification mark on each unit,
                   — scale interval in the form: d = .. .,
                   — maximum additive tare effect in the form: T = + . . . ,
                   — maximum subtractive tare effect in the form: T = - . . .,
                   — tare interval in the form: d f _ . . .,
                   — maximum safe load in the form: Lim .. .,
                   — the special temperature limits in the form: . . . ° C / . . . ° C .
            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 VI, 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 and 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--- 4. 3. 89                              Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                   N o C 55/21
                                                               ANNEX      V
         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 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 points 1 and 2 shall be periodically verified by the Member States.
                                                               ANNEX      VI