21. 2. 89 Official Journal of the European Communities No C 42/5 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Directive on the approximation of the laws of the Member States 
relating to appliances burning gaseous fuels 
COM(88) 786 final — SYN 178 
(Submitted by the Commission on 22 December 1988) 
(89/C 42/04) 
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 
ensuring on their territory the health and safety of their 
people and, where appropriate, of domestic animals and 
goods in relation to the hazards arising out of the use of 
appliances burning gaseous fuels; 
Whereas, in certain Member State, mandatory provisions 
define in particular the safety level required of appliances 
burning gaseous fuels by specifying design, operating 
characteristics and inspection procedures; whereas these 
mandatory provisions do not necessarily lead to different 
safety levels from one Member State to another but do, 
by their disparity, hinder trade within the Community; 
Whereas different conditions as regards types of gas and 
supply pressures are in force in the Member States; 
whereas these conditions are not harmonized because 
each Member State's energy supply and distribution 
situation is peculiar to it; 
Whereas the White Paper on the completion of the 
internal market, approved by the European Council in 
June 1985, provides in paragraphs 65 and 68 for a new 
approach to legislative harmonization; Whereas Community law provides — by way of dero­
gation from one of the fundamental rules of the 
Community, namely the free movement of goods — that 
obstacles to movement within the Community resulting 
from disparities in national legislation relating to the 
placing on the market of products must be accepted in so 
far as such obstacles can be recognized as being 
necessary to satisfy mandatory requirements; 
Whereas the essential health and safety requirements 
must be observed in order to ensure that appliances 
burning gaseous fuels are safe; whereas energy conser­
vation is considered essential; whereas these 
requirements must be applied with discernment to take 
account of the state of the art at the time of 
construction; 
Whereas this Directive therefore contains 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 
design, construction and testing of appliances burning 
gaseous fuels so that products complying with them 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 Electrotechriical Standardi­
zation (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 specifi­
cation (European standard or harmonization 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 
No C 42/6 Official Journal of the European Communities 21. 2. 89 
laying down a procedure for the provision of infor­
mation in the field of technical standards and regu­
lations (*) and the abovementioned general guidelines; 
Whereas, while awaiting the adoption of harmonized 
standards within the meaning of this Directive, 
conformity with the ^essential requirements and the free 
movement of appliances burning gaseous fuels should be 
facilitated by the acceptance, at Community level, of 
products conforming to the national standards whose 
conformity with the essential requirements has been 
confirmed by a Community checking procedure; 
Whereas a check on compliance with the relevant 
technical requirements is necessary in order to provide 
effective protection for users and third parties; whereas 
the existing certification procedures differ from one 
Member State to another; whereas, in order to avoid 
multiple inspections, which are in effect barriers to the 
free movement of appliances burning gaseous fuels, 
arrangements should be made for the mutual recognition 
of certification procedures by the Member States; 
whereas, in order to facilitate mutual recognition of 
certification procedures, harmonized Community 
procedures should be set up and the criteria for 
appointing the bodies responsible for carrying out these 
procedures should be harmonized; 
Whereas the Member States' responsibility on their 
territory for safety, health and energy conservation 
covered by the essential requirements must be recognized 
in a safeguard clause providing for an adequate 
Community procedure; 
Whereas the adressees of any decision taken under this 
Directive must be informed of the reasons for such a 
decision and the legal remedies available to them; 
Whereas the Council adopted on 17 September 1984 a 
framework Directive on gas appliances 
(84/530/EEC) (2), and a separate Directive on gas water 
heaters (84/531/EEC) (J); whereas those Directives 
cover the same area as this Directive and should 
therefore be repealed; 
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 in which the free 
movement of goods, persons, services and capital is 
ensured, 
O OJ No L 109, 26. 4. 1983, p. 8. 
(2) OJ No L 300, 19. 11. 1984, p. 95. 
(») OJ No L 300, 19. 11. 1984, p. 106. HAS ADOPTED THIS DIRECTIVE: 
CHAPTER I 
Scope, placing on the market and free movement 
Article 1 
1. This Directive shall apply to appliances burning 
gaseous fuels used for cooking, heating, hot water 
production, refrigeration, lighting or washing and 
having, where applicable, an operating water 
temperature not exceeding 105 °C, hereinafter referred 
to as 'appliances'. 
2. Appliances, specifically designed for use in 
industrial processes are excluded from the scope defined 
in paragraph 1. 
3. For the purposes of this Directive, 'gaseous fuel' 
means any fuel which is in a gaseous state at a 
temperature of 15 °C under a pressure of 1 bar. 
4. For the purposes of this Directive, 'normally used' 
appliances means: 
— when correctly installed, taking especially into 
consideration the type of gas and the supply pressure 
used in the Member State of destination, and 
— when used with the normal variation of the gas 
quality and the normal fluctuation of the supply 
pressure and when regularly serviced, and 
— when used in accordance with its intended purpose 
or in a way which can be reasonably foreseen. 
Article 2 
1. Member States shall take all necessary steps to 
ensure that the appliances referred to in Article 1 may be 
placed on the market and put into service only if, when 
normally used, they do not compromise the safety of 
persons, domestic animals and property. 
2. Member States shall communicate the types of gas 
and corresponding supply pressures used on their 
territory to the other Member States and the 
Commission. The latter shall ensure that they are 
published in the Official Journal of the European 
Communities. 
21. 2. 89 Official Journal of the European Communities No C 42/7 
Article 3 
Appliances as referred to in Article 1 shall satisfy the 
relevant essential requirements set out in Annex I. 
Article 4 
1. Member States shall not impede the placing on the 
market and the putting into service of appliances which 
satisfy the requirements of this Directive. 
2. Member States shall not impede the placing on the 
market for professional use of safety and controlling 
devices, hereinafter referred to as 'devices', which are 
designed to be part of an appliance and whose charac­
teristics are stated in an attestation as referred to in 
Article 8 (4). 
Article 5 
1. Member States shall presume compliance with the 
relevant essential requirements referred to in Article 3 in 
respect of appliances and devices which are designed for 
incorporation in an appliance when conforming to: 
(a) the relevant national standards implementing the 
harmonized standards, whose reference numbers 
have been published in the Official Journal of the 
European Communities. 
Member States shall publish the reference numbers 
of the said national standards; 
(b) the relevant national standards referred to in 
paragraph 2 in so far as, in the areas covered by such 
standards, no harmonized standards exist. 
2. Member States shall communicate to the 
Commission the texts of their national standards, as 
referred to in paragraph 1 (b), which they regard as 
complying with the essential requirements referred to in 
Article 3. The Commission shall forward these national 
standards forthwith to the other Member States. In 
accordance with the procedure provided for in Article 6 
(2), it shall notify the Member States of those national 
standards in respect of which there is a presumption of 
conformity with the essential requirements referred to in 
Article 3. 
Article 6 
1. Where a Member State or the Commission 
considers that the standards referred to in Article 5 (1) 
do not entirely 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, here­
inafter 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 publi­
cations referred to in Article 5 (1). 2. After receipt of the communication referred to in 
Article 5 (2) the Commission shall consult the 
Committee. Upon receipt of the latter's opinion, the 
Commission shall, within one month, inform the 
Member States whether or not the national standard(s) 
in question are to enjoy the presumption of conformity; 
if so, the Member States shall publish the reference 
number(s) of the (those) standard(s). The Commission 
shall also publish them in the Official Journal of the 
European Communities. 
Article 7 
1. Where a Member State finds that normally used 
appliances bearing the CE mark might compromise the 
safety of persons, domestic animals or property, it shall 
take all appropriate measures to withdraw those 
appliances from the market and 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 standards referred to in 
Article 5(1) have not been applied; 
(b) incorrect application of the standards referred to in 
Article 5 (1); 
(c) shortcomings in the applied standards referred to in 
Article 5 (1) themselves. 
2. The Commission shall enter into consultation with 
the parties concerned as soon as possible. Where, after 
such consultation, the Commission finds that any 
measure as referred to in paragraph 1 is justified, it shall 
immediately so inform the Member State that took the 
action and the other Member States. 
Where the decision referred to in paragraph 1 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 shall initiate the 
procedures referred to in Article 6. 
3. Where an appliance which does not comply bears 
the CE mark, 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. 
No C 42/8 Official Journal of the European Communities 21. 2. 89 
CHAPTER II 
Means of attestation of conformity 
Article 8 
1. The means of attestation of conformity of series-
manufactured appliances shall be: 
(a) at the design level: the EC-type examination as 
referred to in Annex II (1); and 
(b) prior to their being placed on the market, at the 
choice of the manufacturer: 
— the EC declaration of production conformity 
(type 1) referred to in Annex II (2), or 
— the EC declaration of production conformity 
(type 2) referred to in Annex II (3), or 
— the EC verification (type 1) referred to in Annex 
II (4). 
2. The means of attestation of conformity in the case 
of production of an appliance as a single unit shall be the 
EC verification (type 2) referred to in Annex II (5). 
3. After completion of the procedures referred to in 
paragraphs 1 (b) and 2 the CE mark of conformity shall 
be affixed to conforming appliances in accordance with 
Article 10. 
4. The procedures referred to in paragraph 1 shall be 
applied in respect of devices as referred to in Article 4 
(2) which are designed to be part of an appliance. 
However, no CE mark of conformity shall be affixed to 
the device; instead an attestation shall be issued stating 
its characteristics. 
The attestation shall accompany the device. Article 9 
1. Each Member State shall communicate to the other 
Member States and to the Commission the notified 
bodies responsible for carrying out the procedures 
referred to in Article 8. 
The Commission shall publish, in the Official Journal of 
the European Communities, a list of the notified bodies 
with their identification symbols and shall ensure that the 
list is kept up to date. 
2. Member States shall apply the criteria set out in 
Annex V for the evaluation of the bodies to be notified. 
Bodies which satisfy the criteria for evaluation set out in 
the relevant harmonized standards shall be presumed to 
be in conformity with the criteria set out in that Annex. 
3. A Member State which has notified a body must 
withdraw approval if it finds that the body no longer 
meets the criteria referred to in paragraph 2. It shall 
immediately inform the other Member States and the 
Commission accordingly. 
CHAPTER III 
CE mark of conformity 
Article 10 
1. The CE mark of conformity and the inscriptions as 
set out in Annex III shall be affixed in a visible, easily 
legible and indelible form to the appliance or to a data 
plate attached to it. The data plate shall be so designed 
that it cannot be re-used. 
5. Where the appliances are also subject to other 
Community Directives: 
— the appliances shall be checked to ensure compliance 
with the requirements of this Directive in accordance 
with the procedures stated in paragraphs 1 and 2, 
and 
— it shall be ensured that the appliances also comply 
with the requirements of the other Directives in 
accordance with the relevant procedures in those 
Directives. 
The affixing of the CE mark as referred to in paragraph 
3 shall attest that the provisions of all relevant Directives 
are satisfied. 
6. Records and correspondence relating to the means 
of attestation of conformity shall be drafted in the 
official language(s) of the Member State(s) where the 
said procedures are to be carried out or in a language 
accepted by the notified body concerned. 2. The affixing to appliances of marks which are likely 
to be confused with the CE mark shall be prohibited. 
Article 11 
Where it is established that the CE mark has been 
wrongly affixed to appliances or that the attestation for 
devices has been wrongly attributed because: 
— the appliances or the devices do not conform to the 
appliance or the device as referred to in the EC type-
approval certificate, 
— the appliances or the devices conform to the 
appliance or the device as referred to in the EC type-
approval certificate but which do not meet the 
essential requirements applicable to them, 
— the manufacturer has failed to fulfil his obligations as 
specified in Annex II, 
21. 2. 89 Official Journal of the European Communities No C 42/9 
the notified body shall withdraw the right to affix the 
CE mark or to issue the attestation and shall so inform 
the other notified bodies and report to the Member State 
concerned. 
CHAPTER IV 
Final provisions 
Article 12 
Any decision taken pursuant to this Directive which 
results in restrictions on the placing on the market 
and/or putting into service of an appliance shall state the 
precise 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 legal 
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 13 
Directives 84/530/EEC and 84/531/EEC are hereby 
repealed. 
Article 14 
1. Before 1 January 1991 Member States shall adopt 
and publish the laws, regulations and administrative 
provisions necessary in order to comply with this 
Directive. They shall inform the Commission thereof. 
They shall apply such provisions from 31 December 
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. 
Article 15 
This Directive is addressed to the Member States. 
ANNEX I 
1. ESSENTIAL REQUIREMENTS 
1.1. General conditions 
1.1.1. An appliance shall be so designed and built as to operate safely and present no danger to 
persons, domestic animals and property during a reasonable lifetime when normally used as 
defined in Article 1 (4). 
1.1.2. When placing the appliance on the market, the manufacturer's instructions for: 
— installation, servicing and adjustment, intended for the installer, 
— safe use and servicing, intended for the user, 
shall be provided with the appliance in the official language(s) of the Member State of desti­
nation. 
1.1.3. A device intended to be part of an appliance shall be so designed and built as to operate 
correctly for its intended purpose, when incorporated in accordance with the device manu­
facturer's instructions. 
The instructions for installation, adjustment, operation and maintenance shall be provided with 
the device. 
1.2. Materials 
1.2.1. Materials shall be appropriate for their intended purpose and shall withstand the mechanical, 
chemical and thermal conditions to which they will foreseeably be subjected. 
1.2.2. The pertinent properties of materials that are relevant to safety shall be guaranteed by the 
supplier or the manufacturer of the appliance. 
1.2.3. The materials used in the gas circuit shall be such that in the presence of an external fire the risk 
of an explosion shall be minimized. 
1.3. Design and construction 
1.3.1. General 
1.3.1.1. The construction of an appliance shall be such that, when normally used, instability, distortion 
or wear likely to impair its safety will not occur. 
No C 42/10 Official Journal of the European Communities 21. 2. 89 
1.3.1.2. Condensation produced at the start-up and/or during use shall not affect the safe operation of 
the appliance. 
1.3.1.3. The construction of the appliance shall be such that water and inappropriate air penetration into 
the gas circuit shall not occur. 
1.3.1.4. In the case of a normal fluctuation of auxiliary energy the appliance shall continue to operate 
safely. 
1.3.1.5. Abnormal fluctuation or failure of auxiliary energy and its restoration shall not lead to an unsafe 
situation. 
1.3.1.6. Where electricity is used with a nominal value outside the ranges of 50 to 1 000 V in the case of 
alternating current and 75 to 1 500 V in the case of continuous current, the appliance shall also 
be so designed and constructed as to avoid electrical hazards. 
1.3.1.7. Pressurized parts of an appliance shall withstand, without deformation which impairs its safety, 
the mechanical and thermal stresses to which they are subjected. 
1.3.1.8. An appliance shall be so designed and constructed that failure of a device shall not lead to an 
unsafe situation. 
1.3.1.9. If an appliance is equipped with safety and controlling devices, the functioning of the safety 
devices shall not be overruled by the functioning of the controlling devices. 
1.3.1.10. All parts of an appliance which are set at the stage of manufacture and which should not be 
manipulated by the user and the installer shall be appropriately protected. 
1.3.2. Unburned gas release 
1.3.2.1. The construction of an appliance shall be such that the gas leakage rate of an appliance shall be 
limited to a risk-free amount. 
1.3.2.2. The construction of an appliance shall be such that gas release during ignition and/or 
re-ignition and after flame extinction shall be limited in order to avoid a dangerous accumu­
lation of unburned gas in the appliance. 
1.3.3. Ignition 
The construction of the appliance shall be such that, when normally used: 
— ignition and re-ignition shall be smooth, and 
— cross-lighting shall be assured. 
1.3.4. Combustion 
1.3.4.1. The construction of the appliances shall be such that, when normally used, the flame stability 
shall be assured and the combustion products shall not contain unacceptable concentrations of 
harmful elements. 
1.3.4.2. The construction of an appliance shall be such that, when used normally, and also in abnormal 
draught conditions for appliances which are connected to a flue, there will be no unintended 
escape of combustion products. 
1.3.4.3. Instantaneous water heaters and individual heaters, not connected to a flue, shall not cause a 
carbon monoxide concentration in the room exceeding a value of 0,01 %. 
1.3.5. Efficiency 
An appliance shall have a minimum efficiency taking into account the state of the art. 
1.3.6. Temperatures 
1.3.6.1. Parts of an appliance which are intended to be placed in close proximity to the floor or other 
surfaces shall not reach temperatures which present a danger to the surroundings. 
1.3.6.2. The surface temperatures of knobs and handles of appliances intended to be manipulated shall 
not reach values which present a danger to the user. 
21. 2. 89 Official Journal of the European Communities No C 42/11 
1.3.6.3. The surface temperatures of external parts of an appliance intended for domestic use, with the 
exception of surfaces or parts with the function of transmitting heat, shall under operating 
conditions not exceed values which present a danger to the user and in particular to children for 
whom an appropriate contact time has to be taken into account. 
1.3.7. Foodstuffs and water used for sanitary purposes 
Materials and components used for construction of an appliance, which may come into contact 
with food or water used for sanitary purposes, shall not impair their quality. 
ANNEX II 
PROCEDURES FOR ATTESTATION OF CONFORMITY 
1. EC-TYPE EXAMINATION 
1.1. The EC-type examination is that part of the procedure by which a notified body ascertains and 
certifies that an appliance, representative of the production envisaged, meets the provisions of 
the 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. 
1.2.1. 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 IV. 
1.2.2. The manufacturer shall place at the disposal of the notified body an appliance, representative of 
the production envisaged, hereinafter called 'type'. The notified body may request further 
samples of the type is needed for the text programme. 
The type may additionally cover variants of the type provided that those variants do not have 
different characteristics with respect to safety and efficiency. 
1.3. The notified body shall: 
1.3.1. examine the design documentation and verifiy that the type has been manufactured in 
conformity with the design documentation and identify the elements which have been designed 
in accordance with the relevant provisions of the standards and the elements which have been 
designed in accordance with the essential requirements of the Directive; 
1.3.2. perform or have performed the appropriate examination 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 the 
relevant standards were effectively applied where the manufacturer has chosen to do so, thereby 
assuring conformity with the essential requirements. Where the manufacturer declares having 
designed the product entirely to the standards and where conformity of the products to be 
manufactured can be assessed without testing by the notified body, an EC type-examination 
shall be carried out on the sole basis of the design documentation. 
1.4. Where the type meets the provisions of the Directive the notified body shall issue an EC type-
approval certificate to the applicant. The certificate shall contain the conclusions of the exam­
ination, the conditions, if any, for its validity and the necessary data for identification of the 
approved type and, if relevant, descriptions of its functioning. Relevant technical elements such 
as drawings and schemes shall be annexed to the certificate. 
1.5. The notified body shall inform the other notified bodies forthwith of the issuing of the EC 
type-approval certificate and additions as referred to in 1.7, if any, on the said type. They may 
obtain a copy of the EC type-approval certificate and/or its additions 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. 
No C 42/12 Official Journal of the European Communities 21. 2. 89 
1.6. A notified body that refuses to issue or withdraws an EC type-approval certificate 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 all modifications to the approved type with respect to the essential requirements. 
Modifications to the approved type must receive additional approval from the notified body that 
issued the EC type-approval certificate where such changes affect the essential requirements or 
the prescribed conditions for use of the appliance. 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 1) 
2.1. The EC declaration of production conformity (type 1) is that part of the procedure whereby the 
manufacturer declares that the appliances 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 draw up a written declaration of conformity and he or 
his authorized representative in the Community shall affix the CE mark on each appliance. The 
declaration of conformity shall cover either individual or several appliances and be kept by the 
manufacturer. The CE mark shall be accompanied by the identification symbol of the notified 
body responsible for the random checks set out in 2.3. 
2.2. The manufacturer shall take all measures necessary in order that the manufacturing process 
including final product inspection and testing shall ensure homogeneity of production and 
conformity of the appliances with the type as described in the EC type-approval certificate and 
with the requirements of the Directive that apply to them. A notified body, chosen by the manu­
facturer, shall carry out random checks on the appliances as set out in either 2.3 (a) or 2.3 (b). 
2.3. (a) The appliances shall be subject to statistical control by attributes and shall therefore be 
grouped into identifiable batches consisting of units of a single model which are manu­
factured under essentially the same conditions. At random intervals a batch shall be 
examined to determine conformity by applying a sampling plan with the following operating 
characteristics: 
— a standard quality level of the batch submitted, corresponding to a 95 % probability of 
acceptance with a percentage of non-conformity between 0,5 and 1,5 %, 
— a limiting quality of the batch submitted, corresponding to a 5 % probability of 
acceptance with a percentage of non-conformity between 5 and 10 %. 
In those cases where a batch is rejected the notified body shall take the appropriate 
measures to prevent the putting on the market of the batch. 
2.3. (b) On-site checks of appliances shall be undertaken at random intervals of one year or less. An 
adequate number of appliances 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 in order to 
ensure conformity with the relevant requirements of the Directive. In those cases where one 
of the appliances under examination does not conform, the notified body shall take 
measures appropriate to the nature of the defect(s) and it shall also inform the other notified 
bodies of such measures taken. 
3. EC DECLARATION OF PRODUCTION CONFORMITY (type 2) 
3.1. The EC declaration of production conformity (type 2) is the procedure whereby the manu­
facturer who satisfies the obligations of 3.2 declares that the appliances 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 appliance and draw up a written declaration of conformity. This declaration shall cover 
either individual or several appliances and be kept by the manufacturer. The CE mark shall be 
accompanied by the identification symbol of the notified body responsible for EC surveillance. 
21. 2. 89 Official Journal of the European Communities No C 42/13 
3.2. The manufacturer shall have adequately implemented a quality system that will ensure 
conformity of the appliances with the type as described in the EC type-approval certificate and 
with the requirements of this Directive that apply to them. The manufacturer is subject to EC 
surveillance as specified in 3.4. 
3.3. Quality system 
3.3.1. 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 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. 
3.3.2. 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, the organizational structure and responsibilities of management and of 
their powers with regard to product quality, 
— the manufacturing processes, quality control and quality assurance techniques and systematic 
actions that will be used, 
— the examinations and tests that will be carried out before, during and after manufacture and 
the frequency with which they will be carried out, 
— the means to monitor the achievement of the required product quality and the effective 
operation of the quality system. 
3.3.3. The notified body shall examine and evaluate the quality system to determine whether it satisfies 
the requirements referred to in 3.3.2. It shall presume conformity with these requirements in 
respect of quality systems that implement the corresponding harmonized standard. 
it shall notify its decision to the manufacturer and inform the other notified bodies thereof. The 
notification shall contain the conclusions of the examination and the reasoned assessment 
decision. 
3.3.4. The manufacturer 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 tech­
nologies and quality concepts. 
3.3.5. A notified body that withdraws approval of a quality system shall so inform the other notified 
bodies, giving the reasons for the decision. 
3.4. EC surveillance 
3.4.1. The purpose of EC surveillance is to make sure that the manufacturer duly fulfils the obligations 
arising out of the approved quality system. 
3.4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations 
of manufacture, inspection, testing and storage and shall provide it with all necessary infor­
mation, in particular: 
— the quality documentation, 
— the design documentation, 
— the quality records, such as inspection reports and test data, calibration data, qualification 
reports of the personnel concerned, etc. 
3.4.3. The notified body shall make sure that the manufacturer maintains and applies the quality 
system and shall provide a surveillance report to the manufacturer. 
No C 42/14 Official Journal of the European Communities 21. 2. 89 
4. EC VERIFICATION (typel) 
4.1. The EC verification is that part of the procedure whereby a notified body checks and attests that 
the appliances are in conformity with the type as described in the EC type-approval certificate 
and satisfy the requirements of the Directive that apply to them. The notified body shall affix 
the CE mark to each appliance and draws up a written certificate of conformity. 
The certificate shall cover individual or several appliances and be kept by the manufacturer. 
4.2. Each appliance 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 in order to ensure conformity of 
the appliance with the relevant requirements of the Directive. 
5. EC VERIFICATION (type 2) 
5.1. The EC verification is a procedure whereby a notified body checks and attests that an appliance 
is in conformity with the requirements of the Directive that apply too it. The notified body shall 
affix the CE mark to the appliance and draw up a written certificate of conformity. 
The certificate shall be kept by the manufacturer. 
5.2. The design documentation as set out in Annex IV shall be made available to the notified body. 
5.3. The appliance shall be examined and appropriate tests shall be carried out in order to ensure 
conformity of the appliance with the requirements of the Directive. 
If deemed necessary by the notified body, the examinations and the appropriate tests shall be 
carried out after the installation of the appliance. 
ANNEX III 
CE MARK AND INSCRIPTIONS 
1. The CE mark shall consist of the symbol CE as given below, the last two digits of the year in which the 
mark was affixed and the identification symbol of the notified body that has carried out the random 
checks, the EC surveillance or the EC verification. 
2. The appliance or data plate must bear the CE mark together with the following inscriptions: 
— the manufacturer's name or identification symbol, 
— the trade name of the appliance, 
— the electrical supply used, if applicable, 
— the appliance category. 
Additional information needed for installation shall be added according to the nature of the different 
appliances. 
21. 2. 89 Official Journal of the European Communities No C 42/15 
ANNEX IV 
DESIGN DOCUMENTATION 
The design documentation shall contain the following information, so far as is required by the notified 
body for assessment: 
— a general description of the appliance, 
— conceptual designs and manufacturing drawings and schemes of components, sub-assemblies, circuits, 
etc., 
— descriptions and explanations necessary for the understanding of the above, including the operation of 
the appliances, 
— 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, 
— test reports, 
— the manuals for installation and for the user. 
ANNEX V 
MINIMUM CRITERIA FOR EVALUATION OF NOTIFIED BODIES 
The notified bodies designated by the Member States must fulfil the following minimum conditions: 
— availability of personnel and of the necessary means and equipment, 
— technical competence and professional integrity of personnel, 
— independence, in carrying out tests, preparing the reports; issuing the certificates and performing the 
surveillance provided for in this Directive, of staff and personnel in relation to all circles, groups or 
persons directly or indirectly concerned with appliances, 
— maintenance of professional secrecy by personnel, 
— subscription of a civil liability insurance unless that liability is covered by the State under national law. 
Fulfilment of the conditions in the first and second indents shall be verified at intervals by the competent 
authorities of the Member State or by bodies designated by the Member State.