DIRECTIVE 90/384/EEC: EXPLANATION AND INTERPRETATION
The text of this
document was prepared by the Directorate-General Industry of the European Commission,
in collaboration with WELMEC Working Group 2. The Western European Legal Metrology
Cooperation (WELMEC) is a collaboration between the national legal metrology
authorities in all the countries of Western Europe, whose principal aim is to
establish a harmonized and consistent approach to legal metrology in Europe
and to develop and maintain mutual confidence between the legal metrology services.
WELMEC was created, in part, to deal with the obligations, responsibilities and opportunities resulting from the developments in the European Union, such as the establishment of the Internal Market and European Economic Area, and the corresponding new legislative instruments and policies.
This document provides explanation and interpretation in respect of the provisions contained in Council directive 90/384/EEC on non-automatic weighing instruments. It does not provide a systematic treatment of all provisions of the directive, rather deals only with those of the directive's elements of which experience has shown that further clarification was needed
The document will
assist all interested parties in correctly interpreting and applying this piece
of community legislation: Member States of the European Union and Signatories
of the Agreement on the European Economic Area, who transposed the directive
in their respective national legislations; manufacturers of non-automatic weighing
instruments, whether established in the European Economic Area or in third countries;
users of non-automatic weighing instruments; consume
The text of this
document corresponds to the opinion of the services of the European Commission
at the time of preparation. The attention is drawn to the fact that a binding
interpretation of Community legislation can only be given by the Court of Justice
was adopted on 20 June 1990 and came into force on 1 January 1993. It was modified
by directive 93/68/EEC of 22 July 1993, with effect from 1 January 1995.
concerns all non-automatic weighing instruments and is total in application.
This means that no national provisions dealing with the application field of
the directive may exist any more, other than those transposing the directive
areas listed in Article 1.2(a) become controlled areas or continue as controlled
areas as and from 1 January 1993. All other areas of use are deregulated and
fall under Article 1.2(b) from that date.
to the provisions of the transition arrangements, all new instruments being
placed on the Community market from 1 January 1993 must carry either the manufacturer's
mark or name and the maximum weighing capacity, or the CE conformity marking
and the green metrology sticker. In the latter case they shall satisfy the essential
requirements that apply to them and their conformity with these essential requirements
shall have been assessed in accordance with the provisions on conformity assessment.
An instrument in use on 1 January 1993 may continue in use according to the rules in force when the type/design was first placed on the market. It may or may not have been subject to metrological controls prior to 1 January 1993.
instrument is defined in Article 1.1 as a measuring instrument that
uses the action of gravity on a body to determine the mass of the body. A characteristic
that distinguishes a non-automatic weighing instrument from
other weighing instruments is that an operator is required during the weighing
operation to obtain the result, eg to place the load on the load receptor of
the instrument. By this definition, the following types of weighing instrument
among others are included: retail shops scales, laboratory balances, bathroom
scales, baby scales and kitchen scale
Only measuring instruments that meet the definition in Article 1.1 of a non-automatic weighing instrument are within the scope of the directive. Furthermore, legal weighing instruments must indicate the value of the mass (Essential requirements 8.1 of Annex I).
of a non-automatic weighing instrument does not cover instruments which are
used for qualitative analysis that do not indicate mass but the related characteristic
only (eg geological or metallurgical analysis, hectolitre mass of grain, ...),
and counting instruments that do not display mass (eg coin counters, pill counters,
. FREEDOM OF
on the market
The minimal control
foreseen by the directive is that an instrument must bear the manufacturer's
mark or name, and its maximum weighing capacity. An instrument marked in this
way is entitled to free movement on the Community market, that is to say, it
can be marketed in any of the EC Member States without having to comply with
any other requirements concerning metrology. However, the directive identifies
certain applications that require the mandatory use of instruments that bear
the CE conformity marking and the green metrology sticker.
conformity marking and the green metrology sticker
The CE conformity
marking, if accompanied by the green metrology sticker, signifies that the instrument
carrying these two markings satisfies the essential requirements of directive
90/384/EEC and has been subjected to conformity assessment in accordance with
it. Additionally, the CE marking signifies conformity with the provisions of
all other directives applying to the instrument that require the affixing of
the CE conformity marking.
The green metrology
sticker is a supplementary metrology marking, mandatory under directive
90/384/EEC as the CE marking itself, that specifies that directive 90/384/EEC
is (one of) the directive(s) with those essential requirements compliance is
declared by the CE marking. The green metrology sticker is not to be regarded
as what used to be known in the past as an initial verification mark. Such an
initial verification mark does not exist any more for non-automatic weighing
instruments. Consequently, like the CE marking, the green metrology sticker
may not be removed from an instrument that is used for Article 1.2(a) purposes.
The green metrology
sticker is applied to each of the devices to which the essential requirements
apply (see paragraph 2 of chapter 5). The CE marking is carried by the main
part of the instrument only.
Affixing the CE
marking and the green metrology sticker to the instrument is the responsibility
of the manufacturer. This does not imply that the affixation must necessarily
be carried out by the manufacturer himself. It can be carried out under the
manufacturer's responsibility by his authorized representative established within
Since the CE conformity
marking and the green metrology sticker necessarily go together under the directive,
for reasons of simplicity 'CE marking', 'CE marked instrument', etc., refers
hereafter to CE marking plus green metrology sticker, unless specified otherwise.
The special areas
of use requiring CE marked instruments are listed in Article 1.2(a) of the Directive.
All other applications do not require CE marked instruments to be used, these
are covered by Article 1.2(b).
The shape, design,
construction or configuration of the instrument (e.g. bench scale, platform
scale, weighbridge, ...) do not identify its use as an Article 1.2(a) or Article
1.2(b) use. Although the potential use of an instrument can sometimes be readily
identified by its shape, design, etc., (e.g. price computing retail scale, kitchen
scale, postal scale, ...), nevertheless the final decision can only be made
when the instrument is put into service. Taking a postal scale as an example,
post office use would be an Article 1.2.(a) application, private use
in the mail room of a company would be an Article 1.2.(b) application.
that require the mandatory use of CE marked instruments cover the areas of commerce,
health and public administration. They are specified in Article 1.2(a) and are:
of mass for commercial transactions, which deals with trading transactions
where the goods are bought or sold by mass. The cost therefore is directly proportional
to the mass of the product.
of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration,
indemnity or similar type of payment. This type of use not only includes
situations where the payment is directly proportional to the mass, e.g. remuneration,
tax etc., but also situations where the mass value determines the cost of the
service, e.g. post office use, laundry or airport baggage tariff, charge for
transporting goods, disposal of waste.
of mass for the application of laws or regulations; expert opinion given in
court proceedings, which covers the activities where an instrument
is used by a person who is not an expert in metrology but is giving evidence
based on weighing results. Instruments used for the same purposes by experts
from metrological laboratories, government or public authority laboratories
and forensic laboratories are therefore excluded on the condition that such
laboratories keep their instruments properly maintained, calibrated and adjusted.
of mass in the practice of medicine for the weighing of patients for the purposes
of monitoring, diagnosis and medical treatment, which covers those
activities where medical staff are responsible for the weighing of patients.
Examples are the use of weighing instruments in hospitals, health centres or
taken into the community for medical purposes. Medical staff includes all persons
that lawfully carry out the medical weighing tasks concerned in their Member
of mass for making up medicines on prescription in a pharmacy and determination
of mass in analyses carried out in medical and pharmaceutical laboratories,
where medical laboratories are laboratories that carry out analyses at
the request of medical practitioners and pharmaceutical laboratories
are quality control laboratories of manufacturers of medicinal products for
human use. Pharmaceutical laboratories do not include the research and development
laboratories of manufacturers of these medicinal products.
determination of price on the basis of mass for the purposes of direct sales
to the public and the making-up of prepackages. The
former case covers the use of instruments with price calculation, in particular
price-calculating retail sales, and the latter refers to scales used to make
up pre-weighed non-predetermined quantities. Direct sales to the public is explained
in Chapter 14.
All uses other
than Article 1.2.(a) uses are Article 1.2.(b) uses and do not require CE marked
Uses for the following
purposes are considered Article 1.2.(b) uses.
- Sports and sporting records;
- Domestic use (kitchen, bathroom, ...);
- Geological surveys;
- Veterinary medicine;
- Medical practice, except for the weighing of live patients;
- Goods inwards inspection, etc. (checking scales);
- Weighing of goods for customer information only and not for the final
determination of mass (not to be confused with self-service scales that are used for the final determination of mass);
- Weighing for any non-Article 1.2.(a) purpose against payment. The payment represents a situation of commercial transaction for the determination of mass, which does not convert the use into an Article 1.2.(a) use. (Ex: coin operated person weighers).
- The use in quality
systems. The metrological requirements that a measuring instrument, used in
the operation of a quality system, needs to fulfill are, inter alia, that it
has appropriate accuracy and is properly calibrated and periodically recalibrated
against traceable metrological standards by a metrological laboratory. These
requirements apply regardless of the status of the system (private agreement
between two parties, mandatory certification procedure, ...). Although they
do not exclude the use of legal measuring instruments, they do not render them
Also the use of
- Metrological enforcement agents;
- Metrological experts (eg national metrology laboratories, ...);
- Government or
public authority laboratories, forensic laboratories,
with directive 76/211/EEC
76/211/EEC on the making up by mass or by volume of certain prepackaged products
provides in its Annex I, point 4 that legally controlled instruments must be
used for the making up or the checking of prepackages. The use of a non-automatic
weighing instrument for any of these two alternatives is therefore an Article
1.2.(a) use. The right to choose between the two alternatives offered by directive
76/211/EEC is not affected, however, by directive 90/384/EEC.
applications in certain Member States do not require CE marked instruments until
1 January 2003, if on 31 December 1992, the particular Member State has not
had requirements to use a controlled instrument for that application. Therefore,
these Member States must allow the introduction onto their markets of instruments
not carrying the CE marking plus green metrology sticker, for use in these areas
for the full transition period (i.e. 10 years). However, the Member States are
requested to encourage all manufacturers interested in these application areas
to manufacture instruments capable of meeting the essential requirements, sufficiently
in advance of the cutoff date of 1 January 2003.
In relation to
type approvals, a distinction is made between EEC type approvals (granted under
Council directive 73/360/EEC) and national type approvals (those granted under
national legislation other than that which transposes directive 73/360/EEC).
An EEC type approval
shall not be granted after 31 December 1992. Those approvals that have an expiry
date later than 31 December 1992 shall not be renewed.
A national type
approval shall not be granted after 31 December 1992. Those valid on 1 January
1993 may be renewed or modified provided their validity after renewal or modification
does not extend beyond 31 December 2002.
Annex I of the Directive contains the essential requirements that must be met by a non-automatic weighing instrument that is used in Article 1.2.(a) applications. These are the technical and metrological performance requirements for the instrument and include the maximum permitted error.
requirements apply also to devices, included in or connected to a non-automatic
weighing instrument that is used for an Article 1.2.(a) application, if these
devices are themselves also used for that application.
The only exception to this rule is the case of supplementary indicating or printing devices that are included in or connected to a non-automatic weighing instrument that is not used for direct sales to the public, if
- they repeat the result of the weighing operation and cannot influence the correct functioning of the instrument, and
- the result of the weighing operation is printed or recorded correctly and indelibly by a part of the instrument that meets the essential requirements, and
- this result is accessible to both parties concerned by the measurement.
Even through they
may be used for Article 1.2.(a) applications, those supplementary indicating
or printing devices do not have to satisfy the essential requirements, in which
case they must carry the red symbol of restricted use (see chapter 10).
A harmonized European
standard for non-automatic weighing instruments, EN 45501:1992/AC:1993, has
been adopted by CEN/CENELEC. This standard not only sets down technical solutions
to the essential requirements but also the tests that can be used to establish
conformity with the performance requirements.
of this harmonized standard were published, in accordance with Article 5.2,
in the Official Journal of the European Communities, nr. C 153 of 04.06.1994,
page 17. Application of this standard, in whole or in part, provides presumption
of conformity with the corresponding essential requirements.
used to establish conformity with the essential requirements are laid down in
Annex II of the Directive.
weighing instrument must undergo type examination unless it does not contain
electronic devices and its load measuring device does not use a spring to balance
the load. (The latter instruments are so simple that one can abstain from type
examination). The type examination is followed by either EC declaration of type
conformity (guarantee of production quality) or EC verification.
are custom-designed and custom-made for a specific application need only undergo
EC unit verification. This procedure is also open to very small production series
EC type examination
body, chosen by the manufacturer or his authorized representative established
within the Community from among the bodies notified to the Commission for carrying
out such work, tests and certifies that an instrument, representative of the
production envisaged, meets the essential requirements of the Directive. The
notified body issues a type approval certificate that, inter alia, contains
enough information for the identification of the instrument. The certificate
has a validity of 10 years but may be subsequently renewed. In special circumstances,
such as the application of new technologies, the validity of the certificate
may be reduced to 2 years with the allowance for an extension of 3 years.
of type conformity (guarantee of production quality)
To use the procedure
of EC declaration of type conformity (guarantee of production quality) a manufacturer
must make application for approval of his production quality system to one of
the bodies notified to the Commission for carrying out such work. Furthermore,
the correct application of the quality system must be surveyed by that notified
body. The EC declaration of type conformity (guarantee of production quality)
allows that the CE marking and the green metrology sticker are affixed to the
products without verification of the products by a notified body.
is the procedure under which a notified body, chosen by the manufacturer or
his authorized representative, carries out tests to assure itself that the individual
instruments conform to the approved type and to those of the essential requirements
that are to be checked upon completion of the manufacture. In case no type examination
is required, the tests will assure conformity with the essential requirements
EC unit verification
When a single
instrument or very limited number of instruments is/are manufactured, usually
custom-designed, the manufacturer or his authorized representative in the Community
may choose to have conformity established by unit verification. This is the
procedure where a notified body establishes conformity of the instrument with
the essential requirements of the Directive, without the instrument first having
received a type approval
in two stage
assessment procedures of EC declaration of type conformity, EC verification
and EC unit verification may be carried out in a single stage or in two separate
stages, at the manufacturer's choice. In the case of EC declaration of type
conformity we are referring to those tests of the final product which form part
of the manufacturer's quality system. The provisions relating to the choice
of one or two stages, the place of their performance and the responsibilities
of the bodies involved are contained in point 5 of Annex II of the Directive.
for the choice of one or two stage procedure, and place of assessment
After type examination
(unless the instrument is exempted from it), one of the procedures referred
to above must be carried out. The procedure chosen is, in principle, carried
out in one stage at the manufacturer's works, provided transport of the
instrument to its place of use, after establishment of its conformity, does
not require dismantling; the putting into service at the place of use does not
require assembly or installation work that is likely to affect the instrument's
performance; and the gravity value at the place of use is accounted for when
adjusting the instrument, if the weighing results are sensitive to gravity.
The manufacturer may, however, choose to have the procedure carried out in two
In case the conditions
referred to above are not satisfied, the procedure is carried out either in
one stage at the place of use, or in two stages, where stage one is carried
out at the manufacturer's works and stage two at the place of use. If the weighing
results are gravity dependent, stage two must as a minimum comprise all examinations
and tests whose outcome is gravity dependent. In all cases (i.e. whether the
weighing results are gravity dependent or not), stage two must comprise all
examinations and tests not carried out in stage one.
of the bodies involved
When any of the
relevant procedures above are carried out in one stage, each instrument
must carry the identification number of the notified body that has performed
the EC verification or EC unit verification, or the body responsible for the
approval and supervision of the manufacturer's quality system.
When the procedure
is carried out in two stages each instrument that passes from the first
stage to the second must be accompanied by a certificate that details the examinations
and tests carried out in the first stage and the necessary data for the identification
of the instrument. The certificate is drawn up by the notified body in the case
of EC verification or EC unit verification, or the manufacturer when he operates
a quality system.
The tests and
examinations that have not been carried out in the first stage must be carried
out in the second stage. In the case of an instrument sensitive to gravity the
second stager must comprise all examinations and tests where the results are
number of the body or bodies involved in the two stages must be affixed to the
instrument. Where two different bodies have been involved both their numbers
who operates a quality system may carry out the second stage himself if his
quality system certification extends to the place of use of the instrument,
otherwise he may opt for EC verification to finish the second stage
OF CONFORMITY MARKS AND IDENTIFICATION NUMBERS
of the conformity assessment the CE conformity marking and the green metrology
sticker must be affixed by the manufacturer or his authorized representative.
This does not mean that the physical affixation must wait until this point in
time. Since the affixation of CE marking and metrology sticker is the responsibility
of the manufacturer, the manufacturer may make provision for these markings
in advance, the important point being that the markings have no legal significance
until all the procedures are successfully completed and the instrument is placed
on the market.
affixation of their identification numbers is the responsibility of the notified
bodies. Therefore, a notified body may affix its identification number itself,
or have it affixed under its responsibility, e.g. by the manufacturer, if satisfactory
(to the notified body) arrangements are made. Again, the physical affixation
may be carried out in advance.
OTHER MARKINGS AND INSCRIPTIONS
A CE marked instrument
shall also carry the additional markings and inscriptions, detailing the instrument's
specifications, according to the requirements of Annexe IV of the directive.
A CE marked instrument
is presumed to be placed on the market for Art. 1.2. (a) uses and must therefore
satisfy all provisions of the directive pertaining to this category of use,
including the requirements on markings and inscriptions (identification number
of the notified body involved, last two digits of the year of affixing of the
CE marking, ....). An instrument placed on the market for Art. 1.2.(b) uses
may not carry any of the markings and inscriptions required for Art. 1.2.(a)
uses. It must at least carry the manufacturer's mark or name and the maximum
The only exception
to the above rules is provided by those cases where it is without any doubt
that the CE marking was affixed under another directive. An example of such
a situation is the case of an electronic kitchen or bathroom scale, which must,
after expiration of the transition period of directive 89/336/EEC on electromagnetic
compatibility, carry the CE marking (without the green metrology sticker) under
symbol of restricted use
Devices that are
connected to or included as part of a CE marked instrument and have not been
subject to conformity assessment must bear the red symbol of restricted use
with the capital letter M in black crossed by an X. These devices may not be
used for any of the Article 1.2.(a) purposes.
The only exception
of this rule are the supplementary indicating or printing devices referred to
in the third paragraph of chapter 5. If these supplementary devices have not
been subject to conformity assessment they must bear the red symbol of restricted
use, but may nevertheless be used for Article 1.2.(a) purposes.
OF INSTRUMENTS IN USE
used for Article 1.2.(a) purposes must be supervised to see that they continue
to comply with the requirements of the directive. The Member States are free
to establish their own systems of inspection and control but they should ensure
that these do not lead to barriers to trade.
This means inter
alia that the provisions for marking of the instruments under the national systems
of inspection and control, to show their status to user and inspector, shall
not lead to the obligation of having to satisfy additional requirements before
they can be placed on the market or put into service.
APPLYING TO THE USE
are free to establish national rules on the use of legal measuring
instruments, providing these do not lead to barriers to trade. This means e.g.
requirements for the installation of an instrument such that customers can see
the platform and the mass indication where a freight or postage is determined,
or for additional labeling of the instrument in relation to its use to be put
on by the user.
is repealed from the 1 January 1993 except as for the transition arrangements.
A situation of direct sales exists when all of the following conditions are satisfied:
1. The weighing operation is carried out for, and simultaneously with, a trading transaction where goods are bought or sold by mass;
2. The customer is present when the weighing operation is carried out;
3. All aspects
of the trading transaction are concluded at that time and place.
1 excludes weighing operations for the calculation of a toll, tariff, tax, bonus,
penalty, remuneration, indemnity, or similar type of payment. Direct sales is
strictly limited to the buying and selling of goods.
The customer in a trading transaction where goods are bought or sold by mass is the party that is not responsible for the instrument being used for the weighing. The customer is usually the buying party but can, in some cases, be the selling party.
Where the weighing
instrument used is a self service instrument, operated by the customer in the
absence of the other party, this is direct sales.
sales to the public
Direct sales to
the public exists when direct sales as defined above is taking place in respect
of goods being bought or sold by a private person being the ultimate consumer.
Where a need to
carry out trials in working conditions is established, this shall be dealt with
by issuing a type approval certificate, limited in time according to point 1.4
of Annex II of the directive (two years, with possibility of extension by another
three years), and, if necessary, limited in validity according to paragraph
1 of the same point. In the latter case, conditions for validity that one might
think of could be, e.g. the number of instruments covered by the certificate,
the location in which the instruments must be installed, and the like.
are instruments that perform more than one measurement function.
Where a measuring
instrument has a non-automatic weighing mode of operation together with one
or more other measurement modes, then the instrument must be the subject of
conformity assessment under directive 90/384/EEC in so far as it relates to
the non-automatic weighing mode of operation. The other measurement modes could
relate to automatic weighing, volume or length measurement, pressure measurement,
The EC type approval
certificate issued must clearly state that the EC conformity marking and green
metrology sticker cover only the non-automatic weighing mode of operation and
that the other measurement modes are the subject of national controls. These
other measurement modes may not be the subject of national prescriptions in
all Member States.
A hybrid instrument
having a non-automatic weighing mode of operation may therefore carry the CE
conformity marking, as well as a national marking where appropriate.
Where an automatic weighing instruments has a non-automatic mode of operation for the purpose of calibration or setting up only, then the weighing instrument is only subject to national controls related to automatic weighing instruments, not to directive 90/304/EEC.
Of particular relevance is directive 89/336/EEC on electromagnetic compatibility, amended by directive 92/31EEC. Instruments that are used for Article 1.2.(a) applications are covered, for their immunity against electromagnetic disturbances, by directive 90/384/EEC. For their emission of electromagnetic disturbances, however, they are covered by directive 89/336/EEC. Instruments used for Article 1.2(b) purposes are covered by directive 89/336/EEC for emission and immunity.