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, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100A 
thereof, 
Having regard to the proposal from the Commission, 
In cooperation with the European Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas Member States have the responsibility of 
protecting the public against incorrect results of 
weighing operations by means of non-automatic 
weighing instruments when used for certain categories of 
applications; 
Whereas, in each Member State, mandatory provisions 
fix in particular the necessary performance requirements 
of non-automatic weighing instruments by specifying 
metrological and technical requirements, together with 
inspection procedures before and after taking into 
service; whereas these mandatory provisions do not 
necessarily lead to different levels of protection from one 
Member State to another but do, by their disparity, 
hinder trade within the Community; 
Whereas the national provisions ensuring such protection 
must be harmonized in order to guarantee the free 
movement of non-automatic weighing instruments while 
ensuring a justified level of protection in the 
Community; 
Whereas Community legislation as it stands at present 
provides that, notwithstanding one of the fundamental 
rules of the Community, namely the free movement of 
goods, barriers to intra-Community movement resulting 
from disparities in national laws on the use of products have to be accepted in so far as the provisions from those 
national laws are recognized as necessary to ensure that 
the products concerned meet essential requirements; 
whereas the harmonization of laws in the present case 
must therefore be confined to those provisions needed to 
ensure that non-automatic weighing instruments satisfy 
the essential metrological and performance requirements; 
whereas, because they are essential, these requirements 
must replace the corresponding national provisions; 
Whereas this Directive should therefore contain only 
mandatory and essential requirements; whereas, to 
facilitate proof of conformity with the essential 
requirements, it is necessary to have harmonized 
standards at European level, in particular as to the 
metrological, design and construction characteristics, so 
that instruments complying with those harmonized 
standards may be assumed to conform to the essential 
requirements; whereas these standards, harmonized at 
European level, are drawn up by private bodies and must 
remain non-mandatory texts; 
Whereas for that purpose the European Committee for 
Standardization (CEN) and the European Committee 
for Electrotechnical Standardization (Cenelec) are 
recognized as the competent bodies for the adoption of 
harmonized standards in accordance with the general 
guidelines for cooperation between the Commission and 
those two bodies signed on 13 November 1984; whereas, 
for the purposes of this Directive, a harmonized standard 
is a technical specification (European standard or 
harmonized document) adopted by one or both of those 
bodies upon a remit from the Commission in accordance 
with the provisions of Council Directive 83/189/EEC of 
28 March 1983 laying down a procedure for the 
provision of information in the field of technical 
standards and regulations (') and the abovementioned 
general guidelines; 
(') OJ No L 109, 26. 4. 1983, p. 8. 
4. 3. 89 Official Journal of the European Communities No C 55/7 
Whereas assessment of conformity with the relevant 
metrological and technical requirements is necessary to 
provide effective protection for users and third parties; 
whereas the existing conformity-assessment procedures 
differ from one Member State to another; whereas, to 
avoid multiple assessments of conformity, which are in 
effect barriers to the free movement of the instruments, 
arrangements should be made for the mutual recognition 
of conformity-assessment procedures by the Member 
States; whereas, to facilitate the mutual recognition 
of conformity-assessment procedures, harmonized 
Community procedures should be set up, together with 
harmonized criteria for the designation of the bodies 
responsible for carrying out tasks pertaining to the 
conformity assessment procedures; 
Whereas the presence on a non-automatic weighing 
instrument of the CE mark of conformity indicates that 
it satisfies the provisions of this Directive and therefore 
makes it unnecessary to repeat the assessments of 
conformity already carried out; 
Whereas the measures aimed at the gradual estab­
lishment of the internal market must be adopted by 
31 December 1992; whereas the internal market consists 
of an area without internal frontiers within which the 
free movement of goods, persons, services and capital is 
guaranteed, 
HAS ADOPTED THIS DIRECTIVE: 
CHAPTER I 
Field of application; placing on the market; free 
movement 
Article 1 
1. 'A weighing instrument' is defined as a self-
contained instrument or a system for the determination 
of the mass of a body by using the action of gravity on 
that body. The value of the mass of the body must be 
indicated. 
{A system' is a set of interconnected devices assembled to 
carry out a weighing task. A self-contained instrument 
may be part of a larger system. 
'A non-automatic weighing instrument' is defined as a 
weighing instrument that requires the intervention of an 
operator to perform a mass determination. 'A non-automatic weighing instrument' may additionally 
indicate and/or print values of quantities, directly 
derived from the mass value of the body. 
'A non-automatic measuring instrument for the 
measurement of mass-related quantities or from mass-
derived values' is a non-automatic weighing instrument 
as defined above if it uses the action of gravity and if, 
and only in so far as, it indicates mass values. 
This Directive applies to all non-automatic weighing 
instruments, hereafter referred to as 'instruments'. 
2. For the purposes of this Directive, the following 
categories of application apply: 
(a) (1) commercial transactions, 
(2) the determination of a toll, tariff, tax, bonus, 
penalty, indemnity or similar type of payment, 
(3) law enforcement and expert opinion, 
(4) health monitoring, diagnosis and treatment of 
illness and disorders in the medical (human and 
veterinary) practice; 
(b) all applications other than those set out at (a). 
Article 2 
Member States shall take all necessary steps to ensure 
that instruments may be placed on the market and taken 
into service only if, when properly installed and used for 
the purposes for which they are intended, they meet the 
provisions of this Directive that apply to them. 
Article 3 
1. Instruments to be used for any of the applications 
referred to in Article 1 (2) (a) shall satisfy the essential 
requirements set out in Annex 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 
Article 1 (2) (a) are excluded from this requirement. 
2. Instruments not to be used for any of the 
applications referred to in Article 1 (2) (a) need not 
satisfy the essential requirements set out in Annex I but 
may do so, if the manufacturer so wishes. 
No C 55/8 Official Journal of the European Communities 4. 3. 89 
If they do not satisfy the essential requirements they shall 
be manufactured in accordance with sound engineering 
practice of one of the Member States. If, however, they 
do satisfy the essential requirements set out in Annex I 
they may, if the manufacturer so wishes, be subject to 
the conformity assessment as specified in Article 8. 
Article 4 
Member States shall not impede the placing on the 
market and the taking into service of instruments that 
meet the provisions of this Directive. 
Article 5 
1. Member States shall presume conformity with the 
essential requirements referred to in Article 3 in respect 
of instruments complying with the relevant national 
standards implementing the harmonized standards that 
meet the essential requirements referred to in Article 3. 
2. The Commission shall publish the references of the 
harmonized standards, referred to in paragraph 1, in the 
Official Journal of the European 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 the essential requirements referred to 
in Article 3, the Commission or the Member State 
concerned shall bring the matter before the Standing 
Committee set up under Directive 83/189/EEC, 
hereinafter referred to as 'the Committee', giving the 
reasons therefor. The Committee shall deliver an opinion 
without delay. 
In the light of the Committee's opinion, the Commission 
shall inform the Member States whether or not it 
is necessary to withdraw those standards from the 
publications referred to in Article 5 (2). 
Article 7 
1. Where a Member State considers that instruments 
bearing the CE mark of conformity referred to in Annex 
I (2), (3) and (4) do not meet the provisions of this 
Directive when properly installed and used for the 
purposes for which they are intended, it shall take all 
appropriate measures to withdraw those products from 
the market or to prohibit or restrict their being placed on 
the market. The Member State concerned shall immediately inform 
the Commission of any such measure, indicating the 
reasons for its decision and, in particular, whether 
non-compliance is due to: 
(a) failure to meet the essential requirements referred to 
in Article 3, where the instrument does not meet the 
standards referred to in Article 5 (1); 
(b) incorrect application of the standards referred to in 
Article 5 (1); 
(c) shortcomings in the standards referred to in Article 5 
(1) themselves. 
2. The Commission shall enter into consultation with 
the parties concerned as soon as possible. 
The Commission shall immediately inform the Member 
State concerned of the result of such consultation. If the 
Commission finds that the measure is justified it shall 
immediately inform the other Member States. 
If the measure was taken by the Member State on the 
grounds of assumed shortcomings in the standards the 
Commission, after consulting the parties concerned, shall 
bring the matter before the Committee within two 
months if the Member State concerned intends to 
maintain the measures, and shall initiate the procedures 
referred to in Article 6. 
3. Where an Instrument which does not comply bears 
the CE mark of conformity, the competent Member 
State shall take appropriate action against whomsoever 
has affixed the mark and shall inform the Commission 
and the other Member States thereof. 
4. The Commission shall ensure that the Member 
States are kept informed of the progress and outcome of 
this procedure. 
CHAPTER II 
Conformity assessment 
Article 8 
1. For the purposes of this Directive, a distinction is 
made between manufacture of standard instruments and 
manufacture of non-standard instruments, manufacture 
of non-standard instruments being unit or limited series 
manufacture involving typically, but not necessarily, 
custom-designed instruments, special-purpose instru­
ments, and the like. 
Manufacture of standard instruments 
2. Instruments to be used for any of the applications 
referred to in Article 1 (2) (a) shall be subject to the EC 
type-examination referred to in Annex II (1). 
4. 3. 89 Official Journal of the European Communities No C 55/9 
3. Instruments not to be used for any of the 
applications referred to in Article 1 (2) (a) that satisfy 
the essential requirements set out in Annex I may, at the 
choice of the manufacturer, be subject to the EC type-
examination referred to in Annex II (1). 
4. In either of the cases referred to in paragraphs 2 
and 3, instruments not using any electronic device and of 
which the load measuring device does not use any spring 
to balance the load need not be subject to said EC type-
examination but may, at the choice of the manufacturer, 
be subject to it. 
5. Instruments as referred to in paragraph 2, including 
those that have been exempt from the EC type-exam­
ination on the grounds of the provisions of paragraph 4, 
shall prior to their being taken into service be subject, at 
the choice of the manufacturer: 
— either to the EC declaration of production 
conformity (type 2) referred to in Annex II (2), 
— or to the EC verification (type 1) referred to in 
Annex II (3). 
6. Instruments as referred to in paragraph 3 that have 
been subject to the EC type-examination or that have 
been exempted from it on the grounds of the provisions 
of paragraph 4 may, at the choice of the manufacturer, 
be subject, prior to their being taken into service, to any 
of the two procedures referred to in paragraph 5. 
Manufacture of non-standard instruments 
7. Instruments to be used for any of the applications 
referred to in Article 1 (2) (a) shall each be subject to the 
EC verification (type 2), referred to in Annex II (4). 
8. Instruments not to be used for any of the 
applications referred to in Article 1 (2) (a) that satisfy 
the essential requirements set out in Annex I may, at the 
choice of the manufacturer, be subject to the EC verifi­
cation (type 2), referred to in Annex II (4). 
Common provisions 
9. The records and correspondence relating to the 
procedures referred to in paragraphs 2 to 8 shall be 
drafted in an official language of the Member State 
where said procedures will be carried out, or in a 
language accepted by the responsible body. 
Article 9 
1. Member States shall notify to the other Member 
States and the Commission the bodies which they have 
designated for carrying out tasks pertaining to the 
procedures referred to in Article 8, the specific tasks for 
which each body has been designated and the identifi­
cation codes of the designated bodies. The Commission shall publish the list of those notified 
bodies, together with the tasks for which they have been 
designated, in the Official Journal of the European 
Communities and shall ensure that the list is kept up to 
date. 
2. Member States shall apply the minimum criteria, set 
out in Annex V, for the designation of bodies. Bodies 
that satisfy the criteria fixed by the relevant harmonized 
standards are presumed to satisfy the criteria set out in 
Annex V. 
3. A Member State that has designated a body shall 
withdraw the designation if the body no longer meets the 
criteria for designation referred to in paragraph 2. It 
shall immediately inform the other Member States and 
the Commission accordingly. 
CHAPTER III 
CE mark of conformity and inscriptions 
Article 10 
1. The CE mark of conformity and the required 
supplementary data, as described in Annex IV, shall be 
affixed to the instruments concerned in a clearly visible, 
easily legible and indelible form. 
2. The affixing to instruments of marks which are 
likely to be confused with the CE mark of conformity 
shall be prohibited. 
Article 11 
Where it is established that the CE mark of conformity 
has been wrongly affixed to instruments because: 
— they do not conform to the relevant standards 
referred to in Article 5(1), 
— they do not conform to an approved type, 
— they conform to an approved type which does not 
meet the essential requirements applicable to it, or 
— the manufacturer has failed to fulfil his obligations 
under the EC declaration of conformity (type 2), 
the EC type-approval certificate and/or the approval of 
the quality system, as the case may be, shall be 
withdrawn by the competent notified body. 
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 
applications referred to in Article 1 (2) (a) is constructed 
as a system and where that system contains devices that 
have not been subject to conformity assessment as 
referred to in Article 8, each of those devices shall carry 
the inscription 'not permitted for trade purposes' in the 
official languages of the Member State where the 
instrument is taken into service. That inscription shall be 
affixed to the devices in a clearly visible, easily legible 
and indelible form. 
CHAPTER IV 
Control of instruments in service 
Article 13 
1. Instruments that carry the CE mark of conformity 
and are used for any of the applications referred to in 
Article 1 (2) (a) shall be subject to in-service inspection 
by a notified body to ensure that they are still in 
conformity with the type as described in the type-
approval certificate (if applicable) and satisfy the 
requirements of this Directive that apply to them. 
2. They shall be re-verified: 
(a) after repair, modification, or re-assembly; 
(b) after relocation in a geographical area with a gravity 
value that is sufficiently different to justify the 
re-verification, in particular of the error of indi­
cation. 
3. When carrying out these inspections the notified 
body shall carry out the appropriate tests as set out in 
the relevant standards referred to in Article 5, or equi­
valent tests. In the cases referred to in paragraph 2 it 
shall apply the maximum permissible error limits as 
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). Transition period 
Article 14 
1. EEC type-approvals pursuant to Council Directive 
73/360/EEC (*) and national type-approvals, that are 
valid on 1 July 1992, shall remain valid until the date of 
their expiration or until 1 July 2002, whichever date is 
the earlier. After that date they shall nevertheless remain 
in force for the instruments referred to in paragraph 2. 
2. Member States shall allow the further use, as from 
1 July 1992, of instruments that are legally in service at 
that date and for as long as they satisfy the requirements 
that are applicable to them on the basis of their type-
approval or their initial verification. 
CHAPTER VI 
Final provisions 
Article 15 
Any decision taken pursuant to this Directive and 
resulting in restrictions on the taking into service of an 
instrument shall state the exact grounds on which it is 
based. Such a decision shall be notified without delay to 
the party concerned, who shall at the same time be 
informed of the judicial remedies available to him under 
the laws in force in the Member State in question and of 
the time limits to which such remedies are subject. 
Article 16 
1. Before 1 January 1992 Member States shall adopt 
and publish the laws, regulations and administrative 
provisions necessary in order to comply with this 
Directive. They shall forthwith inform the Commission 
thereof. 
They shall apply such provisions from 1 July 1992. 
2. Member States shall communicate to the 
Commission the texts of the provisions of national law 
which they adopt in the field covered by this Directive. 
3. Directive 73/360/EEC is repealed as from 1 July 
1992. 
Article 17 
This Directive is addressed to the Member States. 
C) OJ No L 335, 5. 12. 1973, p. 1. 
4. 3. 89 Official Journal of the European Communities - 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 
Class 
I 
II 
III 
IV Verification scale interval 
(e) 
0,001 g < e 
0,001 g < e < 0,05 g 
0,1 g < e 
0,1 g<e<2g 
5 g < e 
5 g<e Minimum capacity 
Minimum value 
100 e 
20 e 
50 e 
20 e 
20 e 
10 e Maximum capacity 
(max) 
Minimum value 
50 000 e 
100 e 
5 000 e 
100 e 
500 e 
100 e Maximum value 
— 
100 000 e 
100 000 e 
10 000 e 
10 000 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 10kor5 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 10kg 
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. 
No C 55/12 Official Journal of the European Communities 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 maxr = max 
— its minimum capacity min;, with min; = maxj.j and mint = 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. 
Class 
I 
II 
III 
IV Verification scale interval 
(e) ~ 
0,001 g < e; 
0,001 g < ej < 0,05 g 
0,1 g < e; 
0,1 g < ei 
5 g< e; Minimum capacity 
(min) 
Minimum value 
100 ei 
20 e. 
50 ei 
20 ei 
10 ei Maximum capacity 
(max;) 
Minimum value (') 
50 000 e ; + ! 
5 000 e ; + , 
5 000 e i + , 
500 ei + 1 
50 ei + 1 Maximum value 
— 
100 000 e; 
100 000 e; 
10 000 e; 
1 000 e; 
(') For i = r the corresponding column of table 1 applies, with e replaced by er. 
4. 3. 89 Official Journal of the European Communities 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 
Class I 
0 < m < 50 000 e 
50 000 e < m < 200 000 e 
200 000 e < m Class II 
0 < m < 5 000 e 
5 000 e < m < 20 000 e 
20 000 e < m < 100 000 e Class III 
0 < m < 500 e 
500 e < m < 2 000 e 
2000e < m < 10 000 e Class IV 
0 < m < 50 e 
50 e < m < 200 e 
200 e < m < 1 000 e Maximum permissible 
error on EC initial 
conformity assessment 
± 0,5 e 
± 1,0 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. 
No C 55/14 Official Journal of the European Communities 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. 
4. 3. 89 Official Journal of the European Communities No 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. 
No C 55/16 Official Journal of the European Communities 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. 
4. 3. 89 Official Journal of the European Communities No 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. 
No C 55/18 Official Journal of the European Communities 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. 
4. 3. 89 Official Journal of the European Communities No 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 DOCUMENTATION 
The design documentation shall contain in so far as relevant for assessment: 
— a general description of the type, 
— conceptual designs and manufacturing drawings and schemes of components, 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. 
No C 55/20 Official Journal of the European Communities 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: df _ . . ., 
— 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. 
4. 3. 89 Official Journal of the European Communities No 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