1990L0384 — EN — 02.08.1993 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCIL DIRECTIVE
of 20June 1990
on the harmonization of the laws of the Member States relating to non-automatic weighing
instruments
(90/384/EEC)
(OJ L 189, 20.7.1990, p. 1)
Amended by:
Official Journal
No page date
►M1Council Directive 93/68/EEC of 22 July 1993 L 220 1 30.8.1993
Corrected by:
►C1Corrigendum, OJ L 258, 22.9.1990, p. 35 (90/384/EEC)
►C2Corrigendum, OJ L 216, 8.8.1997, p. 99 (93/68/EEC)
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COUNCIL DIRECTIVE
of 20June 1990
on the harmonization of the laws of the Member States relating to
non-automatic weighing instruments
(90/384/EEC)
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 Commission(1),
In cooperation with the European Parliament(2),
Having regard to the opinion of the Economic and Social Committee(3),
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 ofapplications;
Whereas, in 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 going into service;whereas these mandatory provisions do not necessarily lead to differentlevels of protection from one Member State to another but do, by theirdisparity, impede trade within the Community;
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 theCommunity;
Whereas Community legislation as it stands at present provides that,
notwithstanding one of the fundamental rules of the Community, namelythe free movement of goods, barriers to intra-Community movementresulting from disparities in national laws on the use of products have to
be accepted in so far as the provisions of those national laws are
recognized as necessary to ensure that the products concerned meetessential requirements; whereas the harmonization of laws in the presentcase must therefore be confined to those provisions needed to ensure thatnon-automaticweighing instruments satisfy the essential metrologic aland performance requirements; whereas, because they are essential,
these requirements must replace the corresponding national provisions;
Whereas this Directive therefore contains only mandatory and essential
requirements; whereas, to facilitate proof of conformity with theessential requirements, it is necessary to have harmonized standards atEuropean level, in particular as to the metrological, design andconstruction characteristics, so that instruments complying with thoseharmonized standards may be assumed to conform to the essential
requirements; whereas these standards, harmonized at European level,
are drawn up by private bodies and must remain non-mandatory texts;whereas for that purpose the European Committee for Standardization(CEN) and the European Committee for Electrotechnical Standardiza-tion (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 13November 1984; whereas, within the meaning of this Directive, aharmonized standard is a technical specification (European standard orharmonized document) adopted by one or both of those bodies upon aremit from the Commission in accordance with Council Directive 83/1990L0384 — EN — 02.08.1993 — 001.001 — 2
(1) OJ No C 55, 4. 3. 1989, p. 6, and
OJ No C 297, 25. 11. 1989, p. 13.
(2) OJ No C 158, 26. 6. 1989, p. 221, and
OJ No C 149, 18. 6. 1990.
(3) OJ No C 194, 31. 7. 1989, p. 1.
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189/EEC of 28 March 1983 laying down a procedure for the provision of
information in the field of technical standards and regulations(1), as
amended by Directive 88/182/EEC(2), and the abovementioned general
guidelines;
Whereas assessment of conformity with the relevant metrological and
technical provisions is necessary to provide effective protection for users
and third parties; whereas, the existing conformity assessment
procedures differ from one Member State to another; whereas, to avoidmultiple assessments of conformity, which are in effect barriers to thefree movement of the instruments, arrangements should be made for themutual recognition of conformity assessment procedures by the MemberStates; 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 thebodies responsible for carrying out tasks pertaining to the conformityassessment procedures;
Whereas it is therefore essential to ensure that such designated bodies
ensure a high level of quality throughout the Community;
Whereas the presence on a non-automatic weighing instrument of the
►
M1CE marking ◄of conformity or of the sticker bearing the letter
‘M’ indicates that there is a presumption that it satisfies the provisions of
this Directive and therefore makes it unnecessary to repeat theassessments of conformity already carried out;
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 thefree movement of goods, persons, services and capital is guaranteed,
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
Scope, placing on the market, free movement
Article 1
1. A weighing instrument is defined as a measuring instrument
serving to determine the mass of a body by using the action of gravity on
that body. A weighing instrument may also serve to determine other
mass-related magnitudes, quantities, parameters or characteristics.
A non-automaticweighing instrument is defined as a weighing
instrument requiring the intervention of an operator during weighing.
This Directive applies to all non-automatic weighing instruments,
hereinafter referred to as ‘instruments’.
2. A distinction is made in this Directive between two categories of
instrument use:
(a) 1. determination of mass for commercial transactions;
2. determination of mass for the calculation of a toll, tariff, tax,
bonus, penalty, remuneration, indemnity or similar type ofpayment;
3. determination of mass for the application of laws or regulations;
expert opinion given in court proceedings;
4. determination of mass in the practice of medicine for weighing
patients for the purposes of monitoring, diagnosis and medical
treatment;
5. determination of mass for making up medicines on prescription in
a pharmacy and determination of mass in analyses carried out inmedical and pharmaceutical laboratories;1990L0384 — EN — 02.08.1993 — 001.001 — 3
(1) OJ No L 109, 26. 4. 1983, p. 8.
(2) OJ No L 81, 26. 3. 1988, p. 75.
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6. determination of price on the basis of mass for the purposes of
direct sales to the public and the making-up of prepackages;
(b) all applications other than those listed in point 2 (a) of this Article.
Article 2
1. Member States shall take all steps to ensure that instruments may
not be placed on the market unless they meet the requirements of thisDirective which apply to them.
2. Member States shall take all steps to ensure that instruments may
not be brought into service for the uses set out in Article 1 (2) (a) unless
they meet the requirements of this Directive which apply to them,including the conformity assessment procedures referred to in ChapterII, and accordingly bear the CE marking provided for in Article 10.
Article 3
Instruments used for the applications listed in Article 1 (2) (a) must
satisfy the essential requirements set out in Annex I.
In cases where the instrument includes or is connected to devices which
are not used for the applications listed in Article 1 (2) (a), such devicesshall not be subject to the essential requirements.
Article 4
1. Member States shall not impede the placing on the market of
instruments which meet the requirements of this Directive which apply
to them.
2. Member States shall not impede the putting into service for the
uses referred to in Article 1 (2) (a) of instruments which meet the
requirements of this Directive which apply to them.
Article 5
1. Member States shall presume conformity with the essential
requirements referred to in Article 3 in respect of instruments whichcomply with the relevant national standards implementing theharmonized 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 Communities .
Member States shall publish the references of the national standards
referred to in paragraph 1.
Article 6
Where a Member State or the Commission considers that the
harmonized standards referred to in Article 5 (1) do not fully meet theessential requirements referred to in Article 3, the Commission or theMember State concerned shall bring the matter before the StandingCommittee set up under Directive 83/189/EEC, hereinafter referred to as
‘the Committee’, giving its reasons for doing so. 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
►
M1CE marking ◄of conformity referred to in Annex 2, sections 2,
3 and 4, do not meet the requirements of this Directive when properlyinstalled and used for the purposes for which they are intended, it shall1990L0384 — EN — 02.08.1993 — 001.001 — 4
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take all appropriate measures to withdraw those instruments from the
market or to prohibit or restrict their being put into service and/or placedon the market.
The Member State concerned shall immediately inform the Commission
of any such measure, indicating the reasons for its decision, and inparticular whether non-compliance is due to:
(a) failure to meet the essential requirements referred to in Article 3,
where instruments do 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.
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, which took the action, of the result. Should it find thatthe measure is justified it shall immediately inform the other MemberStates.
If the decision is attributed to 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
which has taken the measures intends to maintain them, and shallsubsequently initiate the procedures referred to in Article 6.
3. Where an instrument which does not comply bears the ►
M1CE
marking ◄of conformity, the competent Member State shall take
appropriate action against whomsoever has affixed the ►M1CE
marking ◄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 II
Conformity assessment
Article 8
1. The conformity of instruments to the essential requirements set out
in Annex I may be certified by either of the following procedures as
selected by the applicant:
(a) EC type examination as referred to in Annex II.1, followed either by
the EC declaration of type conformity (guarantee of productionquality) as referred to in Annex II.2, or by the EC verification asreferred to in Annex II.3.
However, EC type examination shall not be compulsory for
instruments which do not use electronic devices and whose load-measuring device does not use a spring to balance the load;
(b) EC unit verification as referred to in Annex II.4.
2. The documents and correspondence relating to the procedures
referred to in paragraph 1 shall be drafted in an official language of theMember State where the said procedures are to be carried out, or in alanguage accepted by the competent body.
3. (a) Where the instruments are subject to other Directives covering
other aspects and which also provide for the affixing of the CEmarking, the latter shall indicate that the instruments in questionare also presumed to conform to the provisions of those otherDirectives.
(b) However, where one or more of the Directives which apply to the
instruments allow the manufacturer, during a transitional period,to choose which arrangements to apply, the CE marking shallindicate conformity only to the Directives applied by the1990L0384 — EN — 02.08.1993 — 001.001 — 5
▼M1
▼M1
manufacturer. In this case, particulars of the Directives applied,
as published in the Official Journal of the European Commu-
nities, must be given in the documents, notices or instructions
required by the Directives and accompanying such instruments.
Article 9
1. Member States shall notify the Commission and the other Member
States of the bodies which they have appointed to carry out the
procedures referred to in Article 8 together with the specific tasks which
these bodies have been appointed to carry out and the identificationnumbers assigned to them beforehand by the Commission.
The Commission shall publish in the Official Journal of the European
Communities a list of the notified bodies and their identification
numbers and the tasks for which they have been notified. TheCommission shall ensure that this list is kept up to date.
2. Member States shall apply the minimum criteria set out in Annex
V for the designation of bodies. Bodies which satisfy the criteria fixed
by the relevant harmonized standards shall be presumed to satisfy the
criteria set out in Annex V.
3. A Member State which has designated a body shall cancel the
designation if the body no longer meets the criteria for designationreferred to in paragraph 2. It shall immediately inform the other MemberStates and the Commission thereof and withdraw the notification.
CHAPTER III
►M1 CE marking ◄of conformity and inscriptions
Article 10
1. The ►M1CE marking ◄of conformity and the required
supplementary data as described in Annex IV.1 shall be affixed in a
clearly visible, easily legible and indelible form to instruments for whichEC conformity has been established.
2. The inscriptions referred to in Annex IV.2 shall be affixed in a
clearly visible, easily legible and indelible form to all other instruments.
3. The affixing of markings on the instruments which are likely to
deceive third parties as to the meaning and form of the CE marking shallbe prohibited. Any other marking may be affixed to the instrumentsprovided that the visibility and legibility of the CE markings is not
thereby reduced.
Article 11
Without prejudice to Article 7:
(a) where a Member State establishes that the CE marking has been
affixed unduly, the manufacturer or his authorized representativeestablished within the Community shall be obliged to make the
instrument conform as regards the provisions concerning the CE
marking and to end the infringement under the conditions imposedby the Member State;
(b) where non-conformity continues, the Member State must take all
appropriate measures to restrict or prohibit the placing on the marketof the instrument in question or to ensure that it is withdrawn from
the market in accordance with the procedures laid down in Article 7.
Article 12
Where an instrument which is used for any of the applications referred
to in Article 1 (2) (a) includes or is connected to devices that have not1990L0384 — EN — 02.08.1993 — 001.001 — 6
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▼B
▼M1
▼B
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been subject to conformity assessment as referred to in Article 8, each of
these devices shall bear the symbol restricting its use as defined byAnnex IV.3. This symbol shall be affixed to the devices in a clearly
visible and indelible form.
CHAPTER IV
Final provisions
Article 13
Member States shall take all steps to ensure that instruments bearing the
►M1CE marking ◄attesting conformity with the requirements of
this Directive continue to conform to those requirements.
Article 14
Any decision taken pursuant to this Directive and resulting in
restrictions on the putting into service of an instrument shall state theexact grounds on which it is based. Such a decision shall be notifiedwithout 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 whichsuch remedies are subject.
Article 15
1. Member States shall, before 1 July 1992, adopt and publish the
laws, regulations and administrative provisions necessary in order tocomply with this Directive. They shall forthwith inform the Commissionthereof.
2. Member States shall apply such provisions from 1 January 1993.3. However, by way of derogation from paragraph 2, Member States
shall permit during a period of 10 years from the date on which they
apply the provisions referred to in paragraph 1 the placing on the marketand/or putting into service of instruments which conform to the rules inforce before that date.
4. 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.
5. Directive 73/360/EEC shall be repealed as from 1 January 1993,
except as regards the application of paragraph 3.
Article 16
This Directive is addressed to the Member States.1990L0384 — EN — 02.08.1993 — 001.001 — 7
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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 that of the
►C1Organisation Internationale de Mètrologie Lègale ◄.
Preliminary observation
Where an instrument includes or is connected to more than one indicating or
printing device used for the applications listed in Article 1 (2) (a), those devices
which repeat the results of the weighing operation and which cannot influence the
correct functioning of the instrument shall not be subject to the essential
requirements if the weighing results are printed or recorded correctly and
indelibly by a part of the instrument which meets the essential requirements and
the results are accessible to both parties concerned by the measurement. However,
in the case of instruments used for direct sales to the public, display and printing
devices for the vendor and the customer must fulfil the essential requirements.
METROLOGICAL REQUIREMENTS
1.Units of mass
The units of mass used shall be the legal units within the meaning of
Directive 80/181/EEC(1), as last amended by Directive 85/1/EEC(2).
Subject to compliance with this condition, the following units are
permitted:
—►C1SI units◄: kilogram, microgram, milligram, gram, tonne,
— Imperial units: pound, ounce (avoirdupois), Troy ounce,
— other non-SI 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 below shall be
converted to the said Imperial units, using simple interpolation.
2.Accuracy classes
2.1. The following accuracy classes have been defined:
I special
II high
III medium
IIII ordinary
The specifications of these classes are given in Table 1.
TABLE 1
Accuracy classes
Class Verification scale interval (e)Minimum
capacity
(Min)Number of verification scale
intervals
n¼Max
e
minimum
valueminimum
valuemaximum
value
I 0,001 g ≤e 100 e 50 000 —
II►C10,001 0,05g◄ 20e100100000 
0,1 g≤e 50 e 5 000 100 000
III 0,1 g ≤e≤2 g 20 e 100 10 000
5g≤e 20 e 500 10 000
IIII 5 g ≤e 10 e 100 1 000
The minimum capacity is reduced to 5e for instruments in classes II and III
for determining a conveying tariff.1990L0384 — EN — 02.08.1993 — 001.001 — 8
(1)►C1OJ No L 39, 15. 2. 1980, p. 40 ◄.
(2) OJ No L 2, 3. 1. 1985, p. 11.g≤e≤
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2.2.Scale intervals
2.2.1. The actual scale interval (d) and the verification scale interval (e) shall be
in the form:
1×1 0k,2×1 0k,o r5×1 0kmass units,
k being any integer or zero.
2.2.2. For all instruments other than those with auxiliary indicating devices:
d=e
2.2.3. For instruments with auxiliary indicating devices the following conditions
apply:
e=1×1 0kg
d<e≤10 d
except for instruments of ►C1class I◄with d < 10−4g, for which
e=1 0−3g.
3.Classification
3.1.Instruments with one weighing range
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 1 by replacement in column
3 of the verification scale interval (e) by the actual scale interval (d).
If d < 10−4g, the maximum capacity of ►C1class I◄may be less than
50 000 e.
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
indicating device.
3.3.2. Each partial weighing ►C1range i◄of multi-interval instruments is
defined by:
— its verification scale interval eiwi-
the(i + 1)>ei
— its maximum capacity Maxiwi-
thMaxr= Max
— its minimum capacity Miniwi-
thMini= Max(i − 1)
and Min1= 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 number1990L0384 — EN — 02.08.1993 — 001.001 — 9
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r = total number of partial weighing ranges
Class Verification scale interval (e)Minimum capa-
city
(Min)Number of verification scale inter-
vals
Minimum valueMinimum
value (1)
n¼Maxi
eiþ1ðÞMaximum value
n¼Maxi
ei
I 0,001 g ≤ei100 e150 000 —
II 0,001 g ≤ei≤0,05g 20 e15 000 100 000
0,1 g≤ei50 e15 000 100 000
III 0,1 g ≤ei20 e1500 10 000
IIII5g≤ei10 e150 1 000
(1) For i = r the corresponding column of Table 1 applies, with e replaced by er.
4.Accuracy
4.1. On implementation of the procedures laid down in Article 8, 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.1990L0384 — EN — 02.08.1993 — 001.001 — 10
TABLE 3
Maximum permissible errors
LoadMaximum permis-
sible errorClass I Class II Class III Class IIII
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 2 000 e < m ≤10 000 e 200 e < m ≤1 000 e ± 1,5 e▼B1990L0384 — EN — 02.08.1993 — 001.001 — 11
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4.2. The maximum permissible errors in service are twice the maximum
permissible errors fixed in section 4.1.
5. Weighing results of an instrument shall be repeatable, and shall be
reproducible by the other indicating devices used and with other 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 in the load.
7.Influence quantities and time
7.1. Instruments of classes II, III and IIII, liable to be used in a tilted position,
shall be sufficiently insensitive to the degree of tilting that can exist in a
normalinstalledcondition.
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:
5ºCforaninstrumentinclassI,
15 ºC for an instrument in class II,
30 ºC for an instrument in class III or IIII.
In the absence of a manufacturer's specification, the temperature range of −
10 ºC to + 40 ºC 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 in class I and in 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 in class II, III or IIII 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 automatically put out of service ►C1 ◄.
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 usedand installed, and when used in an environment for which they are
intended. The value of the mass must be indicated.
8.2. When exposed to disturbances, electronic instruments shall not display the
effects of significant faults, or shall automatically detect and indicate them.
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 during a
period of time that is normal in view of the intended use of such
instruments.
Digital electronic devices shall always exercise adequate control of the
correct 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 shallnot be adversely influenced.1990L0384 — EN — 02.08.1993 — 001.001 — 12
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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 laid down 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 paragraph 1 of this
Annex shall comply with the provisions of Directive 80/181/EEC(1) 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 9e.
An auxiliary indicating device is permitted only to the right of 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, provided that they cannot be
mistaken for primary indications.
10.Printing of weighing results and other weight values
Printed results shall be correct, suitably identified and unambiguous. The
printing shall be clear, legible, non-erasable and durable.
11.Levelling
When appropriate, instruments shall be fitted with a levelling device and a
level indicator, sufficiently sensitive to allow proper installation.
12.Zeroing
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 accurate zeroing
and shall ensure correct net weighing. The operation of the preset tare
device shall ensure correct determination of the calculated net value.
14.Instrumentsfor direct salesto the public witha maximumcapacity notgreater than 100 kg: additional requirements
Instruments for direct sale to the public shall show all essential information
about the weighing operation and, in the case of price-indicating
instruments, shall clearly show the customer the price calculation of the
product to be purchased.
The price to pay, if indicated, shall be accurate.Price-computing instruments shall display the essential indications long
enough for 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 are printed clearly, unambiguously and conveniently arranged
on a ticket or label for the customer.
Instruments shall bear no characteristics that can cause, directly or
indirectly, indications whose interpretation is not easy or straightforward.
Instruments shall safeguard customers against incorrect sales transactions
due to their malfunctioning.1990L0384 — EN — 02.08.1993 — 001.001 — 13
(1)►C1OJNoL39,15.2.1980,p.40 ◄.
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Auxiliary indicating devices and extended indicating devices are not
permitted.
Supplementary devices are permitted only if they cannot lead to fraudulent
use.
Instruments similar to those normally used for direct sales to the public
which do not satisfy the requirements of this section must carry near to the
display the indelible marking ‘Not to be used for direct sale to the public’.
15.Price labelling instruments
Price labelling instruments shall meet the requirements of price indicating
instruments for direct sale to the public, as far as applicable to the
instrument in question. The printing of a price label shall be impossible
below a minimum capacity.1990L0384 — EN — 02.08.1993 — 001.001 — 14
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ANNEX II
1.EC type-examination
1.1. EC type-examination is the procedure whereby a notified body verifies and
certifies that an instrument, representative of the production envisaged,
meets the requirements of this Directive that apply to it.
1.2. The application for 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, hereinafter called the ‘type’.
1.3. The notified body shall:1.3.1. examine the design documentation and verify that the type has been
manufactured in accordance with that documentation;
1.3.2. agree with the applicant on the location where the examinations and/or
tests shall be carried out;
1.3.3. 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;
1.3.4. 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.
1.4. 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. All the relevant technical
elements such as drawings and layouts shall be annexed to the EC type-
approval 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.
In the event of fundamental changes to the design of the instrument, e.g. as
a result of the application of new techniques, the validity of the certificate
may be limited to two years and extended by three years.
1.5. Each notified body shall periodically make available to all Member States
the list of:
— applications received for EC type-examination,
— EC type-approval certificates issued,
— applications for type-certificates refused,— additions and amendments relating to documents already issued.
Each notified body shall moreover inform all the Member States forthwith
of withdrawals of EC type-approval certificates.
Each Member State shall make this information available to the bodies
which it has notified
1.6. The other notified bodies may receive a copy of the certificates together
with the Annexes to them.
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 conformity with the essential requirements of this
Directive or the prescribed conditions for use of the instrument. This1990L0384 — EN — 02.08.1993 — 001.001 — 15
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additional approval is given in the form of an addition to the original EC
type-approval certificate.
2.EC declaration of type conformity (guarantee of production quality)
2.1. The EC declaration of type conformity (guarantee of production quality) is
the procedure whereby the manufacturer who satisfies the obligations of
paragraph 2.2 declares that the instruments concerned are, where
applicable, 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 or his authorized representative established within the
Community shall affix the CE marking to each instrument and the
inscriptions provided for in Annex IV and shall draw up a written
declaration of conformity.
The CE marking shall be accompanied by the identification number of the
notified body responsible for the EC surveillance referred to in paragraph
2.4.
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 this quality
system with a notified body.
The application shall include:
— an undertaking to carry out the obligations arising from the approved
quality system,
— an undertaking to maintain the approved quality system to ensure its
continuing suitability and effectiveness.
The manufacturer shall make available to the notified body all relevant
information, in particular the quality system's documentation and the
design documentation of the instrument.
2.3.2. The quality system shall ensure conformity of the instruments with the
type as described in the EC type-approval certificate and with the
requirements 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 rules, procedures and instructions. This quality system documenta-
tion shall ensure a proper 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, the quality control and assurance
techniques and the systematic measures 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.
It shall notify its decision to the manufacturer and inform the other notified
bodies thereof. The notification to the manufacturer shall contain the
conclusions of the examination and, in the event of refusal, the justification
for the 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 assurance system in relation to changes brought about by, e.g. new
technologies and new quality concepts.
2.3.5. Any notified body that withdraws approval of a quality system shall so
inform the other notified bodies.1990L0384 — EN — 02.08.1993 — 001.001 — 16
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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 grant the notified body access for inspection
purposes to the manufacture, inspection, testing and storage premises and
shall provide it with all necessary information, in particular:
— the quality system documentation,
— the design documentation,— the quality records, e.g. the inspection reports and tests and calibration
data, reports on the qualifications of the personnel concerned, etc.
The notified body shall periodically carry out audits in order to ensure that
the manufacturer is maintaining and applying the quality system; it shall
provide the manufacturer with an audit report.
In addition, the notified body may carry out unscheduled visits to the
manufacturer. During such visits, the notified body may carry out full or
partial audits. It shall provide the manufacturer with a report on the visit,
and, where appropriate, an audit report.
2.4.3. The notified body shall ensure that the manufacturer maintains and applies
the approved quality system.
3.EC verification
3.1. EC verification is the procedure whereby the manufacturer or his
authorized representative established within the Community ensures and
declares that the instruments which have been checked in accordance with
paragraph 3.3 are, where applicable, in conformity to the type described in
the EC type-examination certificate and satisfy the requirements of the
Directive which apply to them.
3.2. The manufacturer shall take all necessary measures in order that the
manufacturing process ensures conformity of the instruments, where
applicable, with the type as described in the EC type-examination
certificate and with the requirements of this Directive which apply to them.
The manufacturer or his authorized representative established within the
Community shall affix the CE marking to each instrument and draw up a
written declaration of conformity.
3.3. The notified body shall carry out the appropriate examinations and tests in
order to check the conformity of the product to the requirements of this
Directive by examination and testing of every instrument, as specified in
paragraph 3.5.
3.4. For instruments not subject to EC type-approval, the documents relating to
the design of the instrument, as set out in Annex III, must be accessible to
the notified body should the latter so request.
3.5. Verification by checking and testing of each instrument.3.5.1. All instruments shall be individually examined and appropriate tests, as set
out in the relevant standard(s) referred to in Article 5, or equivalent tests,
shall be carried out in order to verify their conformity, where applicable, to
the type as described in the EC type-examination certificate and the
requirements of this Directive that apply to them.
3.5.2. The notified body shall affix, or cause to be affixed, its identification
number on each instrument the conformity of which to requirements has
been established and draw up a written certificate of conformity relating to
the tests carried out.
3.5.3. The manufacturer or his authorized representative shall ensure that he is
able to supply the notified body's certificates of conformity on request
4.EC unit verification
4.1. EC unit verification is the procedure whereby the manufacturer or his
authorized representative established within the Community ensures and
declares that the instrument, generally designed for a specific application,
which has been issued with the certificate referred to in paragraph 4.2
conforms to the requirements of this Directive that apply to it. The
manufacturer or his authorized representative shall affix the CE marking to
the instrument and shall draw up a written declaration of conformity.
4.2. The notified body shall examine the instrument and carry out the
appropriate tests, as set out in the respective standard(s) referred to in1990L0384 — EN — 02.08.1993 — 001.001 — 17
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Article 5, or equivalent tests, in order to ensure its conformity to the
relevant requirements of this Directive.
The notified body shall affix, or cause to be affixed, its identification
number to the instrument the conformity of which to requirements has
been established and shall draw up a written certificate of conformity
concerning the tests carried out.
4.3. The aim of the technical documentation relating to the design of the
instrument, as referred to in Annex III, is to enable conformity to the
requirements of this Directive to be assessed and the design, manufacture
and operation of the instrument to be understood. It must be accessible to
the notified body.
4.4. The manufacturer or his authorized representative shall ensure that he is
able to supply the notified body's certificates of conformity on request.
5.Common provisions
5.1. The EC declaration of type conformity (guarantee of production quality),
the EC verification, and the EC unit verification may be carried out at the
manufacturer's works or any other location if 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 gravity value at the place of putting into service is taken into
consideration or 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 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-dependent, and the first stage all other examinations
and tests. The second stage shall be carried out at the place of use of the
instrument. If 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 5.1, and where these two stages will be carried
out by different parties, an instrument which has undergone the first stage
of the procedure shall bear the identification number of the notified body
involved in that stage.
5.3.2. The party which 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 which carries out the second stage of the procedure shall carry
out those examinations and tests that have not yet been carried out.
The manufacturer or his authorized representative shall ensure that he is
able to supply the notified body's certificates of conformity on request.
5.3.3. The manufacturer who has opted for the EC declaration of type conformity
(guarantee of production quality) in stage one may either use this same
procedure in stage two or decide to continue in stage two with EC
verification.
5.3.4. The CE marking shall be affixed to the instrument on completion of the
second stage, along with the identification number of the notified body
which took part in the second stage.1990L0384 — EN — 02.08.1993 — 001.001 — 18
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ANNEX III
DESIGN DOCUMENTATION
The technical documentation must render the design, manufacture and operation
of the product intelligible and enable an assessment to be made of its conformity
with the requirements of the Directive.
The documentation shall include in so far as relevant for assessment:
— a general description of the type,
— conceptual designs and manufacturing drawings and plans of components,
sub-assemblies, circuits, etc.,
— descriptions and explanations necessary for the understanding of the above,
including the operation of the instrument,
— 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,— the EC type-approval certificates and the results of relevant tests on
instruments containing parts identical to those in the design.1990L0384 — EN — 02.08.1993 — 001.001 — 19
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ANNEX IV
1.Instruments subject to the EC conformity assessment procedure
1.1. These instruments must bear:
(a) — the CE conformity marking comprising the CE symbol as described
in Annex VI, ►C2 ◄
— the identification number(s) of the notified body/bodies that has/have
carried out the EC surveillance or the EC verification.
The abovementioned marking and inscriptions shall be affixed to the
instrument distinctly grouped together;
(b) a green sticker at least 12,5 mm × 12,5 mm square bearing a capital
letter ‘M’ printed in black;
(c) the following inscriptions:
— the number of the EC type-approval certificate, where appropriate,
— the 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=,
— the last two digits of the year in which the CE marking was affixed,
plus, when applicable:
— serial number,
— for instruments consisting of separate but associated units:
identification mark on each unit,
— scale interval if it is different from e, in the form d=… ,
— maximum additive tare effect, in the form T=+… ,
— maximum subtractive tare effect if it is different from Max, in the
formT=−… ,
— tare interval if it is different from d, in the form d
T=… ,
— maximum safe load if it is different from Max, in the form Lim …,— the special temperature limits, in the form … ºC/… ºC,— ratio between load recepter and load.
1.2. The instruments shall have adequate facilities for the affixing of the
►
M1CE marking ◄of conformity and/or inscriptions. These shall be
such that it shall be impossible to remove the ►M1CE marking ◄and
inscriptions without damaging them, and that the ►M1CE marking ◄and
inscriptions shall be visible when the instrument is in its regular operating
position.
1.3. 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.
1.4. The inscriptions Max, Min, e,d,shall also be shown near the display of the
result if they are not already located there.
1.5. Each load measuring device which is connected or can be connected to one
or more load receptors shall bear the relevant inscriptions relating to the said
load receptors.
2.Other instruments
The other instruments must bear:
— the manufacturer's mark or name,
— maximum capacity in the form Max …
These instruments may not bear the stickers provided for in 1.1 (b).
3.Restrictive use symbol specified in Article 12
This symbol shall be constituted by a capital letter ‘M’ printed in black on a
red background at least 25 mm × 25 mm square with two intersecting
diagonals forming a cross.1990L0384 — EN — 02.08.1993 — 001.001 — 20
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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 bodies shall work independently 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.1990L0384 — EN — 02.08.1993 — 001.001 — 21
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ANNEX VI
CE CONFORMITY MARKING
— The CE conformity marking shall consist of the initials ‘CE’ taking the
following form:
— If the CE marking is reduced or enlarged the proportions given in the above
graduated drawing must be respected.
— The various components of the CE marking must have substantially the same
vertical dimension, which may not be less than 5 mm.1990L0384 — EN — 02.08.1993 — 001.001 — 22