Proposal for a Directive of the European Parliament and of the Council relating to appliances burning gaseous fuels (Codified version)
Date: 2007-10-25
Institutions: European Commission
Subjects: codification of EU law, gas appliance, harmonisation of standards, safety standard, technical standard

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 25.10.2007 
COM(2007) 633 final 

2007/0225 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

relating to appliances burning gaseous fuels 

(Codified version) 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

In  the  context  of  a  people’s  Europe,  the  Commission  attaches  great  importance  to 
simplifying  and  clarifying  Community  law  so  as  to  make  it  clearer  and  more 
accessible to the ordinary citizen, thus giving him new opportunities and the chance 
to make use of the specific rights it gives him. 

This aim cannot be achieved so long as numerous provisions that have been amended 
several times, often quite substantially, remain scattered, so that they must be sought 
partly  in  the  original  instrument  and  partly  in  later  amending  ones.  Considerable 
research work, comparing many different instruments, is thus needed to identify the 
current rules. 

For  this  reason  a  codification  of  rules  that  have  frequently  been  amended  is  also 
essential if Community law is to be clear and transparent. 

On  1  April  1987  the  Commission  therefore  decided1  to  instruct  its  staff  that  all 
legislative acts should be codified after no more than ten amendments, stressing that 
this  is  a  minimum  requirement  and  that  departments  should  endeavour  to  codify  at 
even  shorter  intervals  the  texts  for  which  they  are  responsible,  to  ensure  that  the 
Community rules are clear and readily understandable. 

The  Conclusions  of 
the  Edinburgh  European  Council 
(December 1992) confirmed this2, stressing the importance of codification as it offers 
certainty as to the law applicable to a given matter at a given time. 

the  Presidency  of 

Codification  must  be  undertaken  in  full  compliance  with  the  normal  Community 
legislative procedure. 

Given  that  no  changes  of  substance  may  be  made  to  the  instruments  affected  by 
codification, the European Parliament, the Council and the Commission have agreed, 
by  an  interinstitutional  agreement  dated  20  December  1994,  that  an  accelerated 
procedure may be used for the fast-track adoption of codification instruments. 

is 

this  proposal 

to  undertake  a  codification  of  Council 
The  purpose  of 
Directive 90/396/EEC  of  29  June  1990  on  the  approximation  of  the  laws  of  the 
Member States relating to appliances burning gaseous fuels3. The new Directive will 
supersede  the  various  acts  incorporated  in  it4;  this  proposal  fully  preserves  the 
content of the acts being codified and hence does no more than bring them together 
with only such formal amendments as are required by the codification exercise itself. 

COM(87) 868 PV. 
See Annex 3 to Part A of the Conclusions. 
Carried out pursuant to the Communication from the Commission to the European Parliament and the 
Council – Codification of the Acquis communautaire, COM(2001) 645 final. 
See Annex VI, Part A of this proposal. 

1. 

2. 

3. 

4. 

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5. 

The codification proposal was drawn up on the basis of a preliminary consolidation, 
in  all  official  languages,  of  Directive  90/396/EEC  and  the  instrument  amending  it, 
carried out by the Office for Official Publications of the European Communities, by 
means  of  a  data-processing  system.  Where  the  Articles  have  been  given  new 
numbers,  the  correlation  between  the  old and  the  new  numbers  is  shown  in  a  table 
contained in Annex VII to the codified Directive. 

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2007/0225 (COD) 

(cid:208) 90/396/EEC (adapted) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

relating to appliances burning gaseous fuels 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 95 thereof, 

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Economic and Social Committee2, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty3, 

Whereas: 

(1) 

Council Directive 90/396/EEC of  29 June 1990  on the  approximation of  the laws of 
the Member States relating to appliances burning gaseous fuels4 has been substantially 
amended5.  In  the  interests  of  clarity  and  rationality  the  said  Directive  should  be 
codified. 

(cid:208)  

(2)  Member States are responsible for ensuring the health and safety on their territory 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. 

(cid:208) 90/396/EEC Recital 1 

1 
2 
3 
4 
5 

OJ C ⌦ […], […], p. […] ⌫. 
OJ ⌦ […], […], p. […] ⌫. 
OJ […] […], […], p. […]. 
OJ L 196, 26.7.1990, p. 15. Directive as amended by Directive 93/68/EEC (OJ L 220, 30.8.1993, p. 1). 
See Annex VI, Part A. 

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(cid:208) 90/396/EEC Recital 2 

(3) 

In  certain  Member  States,  mandatory  provisions  define  in  particular  the  safety  level 
required  of  appliances  burning  gaseous  fuels  by  specifying  design,  operating 
characteristics  and  inspection  procedures.  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. 

(4) 

Different  conditions  as  regards  types  of  gas  and  supply  pressures  are  in  force  in  the 
Member  States.  These  conditions  are  not  harmonised  because  each  Member  State's 
energy supply and distribution situation is peculiar to it. 

(cid:208) 90/396/EEC Recital 3 

(cid:208) 90/396/EEC Recital 5 (adapted) 

(5) 

Community law provides - by way of derogation 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 
marketing of products must be accepted in so far as such obstacles can be recognised 
as being necessary to satisfy mandatory requirements. Therefore, the harmonisation of 
legislation in the present case ⌦ should ⌫ be limited to the provisions necessary to 
satisfy  both  the  mandatory  and  essential  requirements  regarding  safety,  health  and 
energy  conservation  in  relation  to  gas  appliances.  These  requirements ⌦ should ⌫ 
replace the national provisions in this matter because they are essential requirements. 

(6) 

The  maintenance  or  improvement  of  the  level  of  safety  attained  in  Member  States 
constitutes one of the essential aims of this Directive and of safety as defined by the 
essential requirements. 

(cid:208) 90/396/EEC Recital 6 

(7) 

The  essential  safety  and  health  requirements  ⌦ should ⌫  be  observed  in  order  to 
ensure  that  appliances  burning  gaseous  fuels  are  safe.  Energy  conservation  is 
considered  essential.  These  requirements ⌦ should ⌫  be  applied  with  discernment 
to take account of the state of the art at the time of construction. 

(cid:208) 90/396/EEC Recital 7 (adapted) 

(8) 

This Directive ⌦ should ⌫ therefore only ⌦ contain ⌫ essential requirements. To 
facilitate  proof of conformity  with the  essential requirements, it is necessary to have 
harmonised standards at ⌦ Community ⌫ level in particular as to the construction, 

(cid:208) 90/396/EEC Recital 8 (adapted) 

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operation  and  installation  of  appliances  burning  gaseous  fuels  so  that  products 
complying with them may be assumed to conform to the essential requirements. These 
standards, harmonised at ⌦ Community ⌫ level, are drawn up by private bodies and 
must  remain  non-mandatory  texts.  For  that  purpose  the  European  Committee  for 
Standardisation (CEN), the European Committee for Electrotechnical Standardisation 
(Cenelec)  and  ⌦ the  European  Telecommunications  Standards  Institute  (ETSI) ⌫ 
are  recognised  as  the  competent  bodies  for  the  adoption  of  harmonised  standards  in 
accordance  with  the  general  guidelines  for  cooperation  between  the  Commission, 
⌦ the  European  Free  Trade  Association  (EFTA) ⌫  and  those  ⌦ three ⌫  bodies 
signed on 28 March 20036.  

(cid:208) 93/68/EEC Recitals 1, 2 and 3 
(adapted) 

(9)  ⌦ The  Council  has  adopted  a  series  of  Directives  designed  to  remove  technical 
barriers  to  trade  in  accordance  with  the  principles  established  in  Resolution  of 
7 May 1985  on  a  new  approach  to  technical  harmonization  and  standards7;  each  of 
these Directives provides for the affixing of the ‘CE’ marking. The Commission, in its 
communication  of  15  June  1989  on  a  global  approach  to  certification  and  testing8, 
proposed that common rules be drawn up concerning a ‘CE’ conformity marking with 
a  single  design.  The  Council,  in  its  Resolution  of  21  December  1989  on  a  global 
approach to conformity assessment9, approved as a guiding principle the adoption of a 
consistent approach such as this with regard to the use of the ‘CE’ marking. ⌫ The 
two  basic  elements  of  the  new  approach  which  ⌦ should ⌫  be  applied  are  the 
essential requirements and the conformity assessment procedures.  

(cid:208) 90/396/EEC Recital 10 
(adapted) 

(10)  A check on compliance with the relevant technical requirements is necessary in order 
to  provide  effective  protection  for  users  and  third  parties.  The  existing  certification 
procedures  differ  from  one  Member  State  to  another.  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.  In  order  to  facilitate  mutual  recognition  of 
certification  procedures,  harmonised  Community  procedures  and  the  criteria  for 
appointing the bodies responsible for carrying out these procedures should be ⌦ set 
up ⌫. 

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9 

OJ C 91, 16.4.2003, p. 7. 
OJ C 136, 4.6.1985, p. 1. 
OJ C 231, 8.9.1989, p. 3 and OJ C 267, 19.10.1989, p. 3. 
OJ C 10, 16.1.1990, p. 1. 

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(11)  The  Member  States'  responsibility  on  their  territory  for  safety,  health  and  energy 
conservation covered by the  essential  requirements ⌦ should ⌫ be recognised in a 
safeguard clause providing for an adequate Community procedure. 

(cid:208) 90/396/EEC Recital 11 
(adapted) 

(12)  The addressees of any decision taken under this Directive ⌦ should ⌫ be informed 

of the reasons for such a decision and the legal remedies available to them. 

(cid:208) 90/396/EEC Recital 12 
(adapted) 

(13)  This  Directive  should  be  without  prejudice  to  the  obligations  of  the  Member  States 
relating  to  the  time-limits  for  transposition  into  national  law  and  application  of  the 
Directives in Annex VI, Part B, 

(cid:208)  

HAVE ADOPTED THIS DIRECTIVE: 

CHAPTER 1 

(cid:208) 90/396/EEC 

Scope, ⌦ definitions, ⌫ placing on the market and free 
movement 

(cid:208) 90/396/EC (adapted) 

1. This Directive shall apply to ⌦ appliances and fittings ⌫. 

Article 1 

⌦ Appliances  specifically  designed  for  use  in  industrial  processes  carried  out  on  industrial 
premises shall be excluded from its scope. ⌫ 

⌦ 2. For the purposes of this Directive the following definitions shall apply: ⌫ 

(a) 

“appliances”  ⌦ means ⌫  appliances  burning  gaseous  fuels  used  for  cooking, 
heating,  hot  water  production,  refrigeration,  lighting  or  washing  and  having,  where 
applicable, a normal water temperature not exceeding 105 °C; forced draught burners 

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(b) 

(c) 

and heating bodies to be equipped with such burners ⌦ shall ⌫ also be considered 
as appliances; 

“fittings” ⌦ means ⌫ safety devices, controlling devices or regulating devices and 
sub-assemblies, other than forced draught burners and heating bodies to be equipped 
with such burners separately marketed for trade use and designed to be incorporated 
into an appliance burning gaseous fuel or assembled to constitute such an appliance;  

(cid:208) 90/396/EEC Recital 8, last 
sentence (adapted) 

(CEN), 

the  European  Committee 

“harmonised standard” ⌦ means ⌫ a technical specification (European standard or 
harmonisation  document)  adopted  by  ⌦ the  European  Committee 
for 
Standardisation 
for  Electrotechnical 
Standardisation  (Cenelec)  or  the  European  Telecommunications  Standards  Institute 
(ETSI) or by two or three of those bodies ⌫ upon a remit from the Commission in 
accordance with Directive 98/34/EC of the European Parliament and of the Council10 
and  the  general  guidelines  ⌦ for  cooperation  between  the  Commission,  the 
European Free Trade Association (EFTA) and those three bodies signed on 28 March 
2003; ⌫ 

(d) 

“gaseous fuel” means any fuel which is in a gaseous state at a temperature of 15 °C 
under a pressure of 1 bar. 

(cid:208) 90/396/EEC (adapted) 

(cid:208) 90/396/EEC (adapted) 

3. For the purposes of this Directive, an appliance is said to be ‘normally used’ when it is: 

(a) 

(b) 

(c) 

correctly  installed  and  regularly  serviced  in  accordance  with  the  manufacturer's 
instructions; 

used with a normal variation in the gas quality and a normal fluctuation in the supply 
pressure; and 

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. 

10 

OJ L 204, 21.7.1998, p. 37. 

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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 before 1 January 1991. 
They shall also communicate all changes in good time.  

The Commission shall ensure that this information is published in the Official Journal of the 
European Union. 

(cid:208) 90/396/CE 

Article 3 

Appliances and fittings shall satisfy the essential  requirements applicable to them set  out in 
Annex I. 

(cid:208) 93/68/EEC Art.10 pt.2 

Article 4 

1.  Member  States  may  not  prohibit,  restrict  or  impede  the  placing  on  the  market  and  the 
putting  into  service  of  appliances  which  comply  with  this  Directive  and  which  bear  the  CE 
marking provided for in Article 10. 

2.  Member  States  may  not  prohibit,  restrict  or  impede  the  placing  on  the  market  of  fittings 
accompanied by a certificate as referred to in Article 8(4). 

(cid:208) 90/396/EEC (adapted) 

1.  Member  States  shall  presume  compliance  with  the  essential  requirements  ⌦ set  out  in 
Annex I ⌫ of appliances and fittings when they conform to: 

Article 5 

(a) 

the  national  standards  applicable  to  them  implementing  the  harmonised  standards 
whose  reference  numbers  have  been  published  in  the  Official  Journal  of  the 
European Union; 

(cid:208) 90/396/CE 

(b) 

the national standards applicable to them  in so far as, in the areas covered  by such 
standards, no harmonised standards exist. 

(cid:208) 90/396/EEC (adapted) 

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2. Member States shall publish the reference numbers of ⌦ the national standards referred to 
in paragraph 1(a) ⌫.  

⌦ They ⌫  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 
⌦ set out in Annex I ⌫.  

The  Commission  shall  forward  these  national  standards  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  which  are  presumed  to  conform  with  the  essential  requirements 
⌦ set out ⌫ ⌦ Annex I ⌫. 

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  ⌦ set  out  in  Annex I ⌫,  the 
Commission  or  the  Member  State  concerned  shall  bring  the  matter  before  the  standing 
committee set up under ⌦ Article 5 of ⌫ Directive 98/34/EC, hereinafter referred to as ‘the 
committee’, giving the reasons therefore. 

The committee shall deliver an opinion without delay. 

(cid:208) 90/396/EEC 

(cid:208) 90/396/CE (adapted) 

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 
⌦ the first subparagraph of ⌫ Article 5(2). 

2.  After  receipt  of  the  communication  referred  to  in  ⌦ the  second  subparagraph  of ⌫ 
Article 5(2), the Commission shall consult the committee. 

(cid:208) 90/396/EEC 
(cid:206)1 93/68/EEC Art. 10 pt. 1 

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  they  are,  the  Member  States  shall  publish  the  reference 
numbers of those standards. 

The Commission shall also publish them in the Official Journal of the European Union. 

1. Where a Member State finds that normally used appliances bearing the (cid:206)1 CE marking  
might  compromise  the  safety  of  persons,  domestic  animals  or  property,  it  shall  take  all 

Article 7 

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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: 

(cid:208) 90/396/EC 

(a) 

failure  to  meet  the  essential  requirements  ⌦ set  out  in  Annex  I ⌫,  where  the 
appliance does not correspond to the standards referred to in Article 5(1); 

(cid:208) 90/396/EEC (adapted) 

(b) 

(c) 

incorrect application of the standards referred to in Article 5(1); 

shortcomings in the standards referred to in Article 5(1) themselves. 

(cid:208) 90/396/EEC 

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 
measure 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 (cid:206)1 CE marking , the competent 
Member  State  shall  take  appropriate  action  against  whomsoever  has  affixed  the  ⌦ CE 
marking ⌫ and shall inform the Commission and the other Member States thereof. 

(cid:208) 90/396/EEC (adapted) 
(cid:206)1 93/68/EEC Art. 10 pt. 1 

4. The Commission shall ensure that the Member States are kept informed of the progress and 
outcome of the procedures. 

(cid:208) 90/396/EEC 

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CHAPTER 2  

Means of certification of conformity 

Article 8 

1. The means of certification of conformity of series-manufactured appliances shall be: 

(a) 

(b) 

the EC type-examination as referred to in point 1 of Annex II; and 

prior to their being placed on the market, at the choice of the manufacturer: 

(i) 

the EC declaration of conformity to type referred to in point 2 of Annex II, or 

(ii) 

the  EC  declaration  of  conformity  to  type  (guarantee  of  production  quality) 
referred to in point 3 of Annex II, or 

(iii) 

the EC declaration of conformity to type (guarantee of product quality) referred 
to in point 4 of Annex II, or 

(iv)  EC verification as referred to in point 5 of Annex II. 

(cid:208) 90/396/EEC 
(cid:206)1 93/68/EEC Art. 10 pt. 1 

2.  In  the  case  of  production  of  an  appliance  as  a  single  unit  or  in  small  quantities,  EC 
verification  by  single  unit,  as  referred  to  in  point  6  of  Annex  II,  may  be  chosen  by  the 
manufacturer. 

3.  After  completion  of  the  procedures  referred  to  in  paragraphs  1(b)  and  2,  the 
(cid:206)1 CE conformity marking  shall be affixed to conforming appliances in accordance with 
Article 10. 

(cid:208) 90/396/EEC (adapted) 
(cid:206)1 93/68/EEC Art. 10 pt. 1 

4. The ⌦ means of certification of conformity ⌫ referred to in paragraph 1 shall be applied 
in respect of fittings with the exception of the affixing of the (cid:206)1 CE conformity marking  
and, where appropriate, the drawing-up of the declaration of conformity. 

A certificate shall be issued declaring the conformity of the fittings with the provisions of this 
Directive  and  stating  their  characteristics  and  how  they  must  be  incorporated  into  an 
appliance  or  assembled  to  assist  compliance  with  the  essential  requirements  applicable  to 
finished appliances ⌦ set out in Annex I ⌫. 

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The certificate shall be supplied with the fitting. 

(cid:208) 90/396/EEC 

5.  Where  the  appliances  are  covered  by  other  Directives  dealing  with  other  aspects  and 
specifying the affixing of the CE marking, the latter shall indicate that the appliances are also 
presumed to conform to the provisions of those Directives. 

(cid:208) 93/68/EEC Art. 10 pt. 3 
(adapted) 

(cid:208) 93/68/EEC Art.10 pt.3 

However, where one or more of these Directives allow the manufacturer, during a transitional 
period, to choose which arrangements to apply, the CE marking shall indicate conformity to 
the provisions only of those Directives applied by the manufacturer. In this case, particulars of 
the Directives applied, as published in the Official Journal of the European Union, must be 
given in the documents, notices or instructions required by the Directives and accompanying 
such devices. 

6.  Records  and  correspondence  relating  to  the  means  of  certification  of  conformity  shall  be 
drawn  up  in  the  official  language(s)  of  the  Member  State  where  the  body  responsible  for 
carrying out these procedures is established or in a language accepted by it. 

(cid:208) 90/396/EEC 

Article 9 

1.  Member  States  shall  notify  the  Commission  and  the  other  Member  States  of  the  bodies, 
which they have appointed to carry out the procedures referred to in Article 8 together with 
the specific tasks which these bodies have been appointed to carry out and the identification 
numbers assigned to them beforehand by the Commission. 

(cid:208) 93/68/EEC Art. 10 pt. 4 

The  Commission  shall,  for  information,  publish  in  the  Official  Journal  of  the  European 
Union,  a  list  of ⌦ those ⌫  bodies,  and  the  identification  numbers  it  has  assigned  to  them 
and shall ensure that the list is kept up to date. 

(cid:208) 93/68/EEC Art. 10 pt. 4 
(adapted) 

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(cid:208) 90/396/EEC 

2.  Member  States  shall  apply  the  criteria  set  out  in  Annex  V  for  assessing  the  bodies  to  be 
notified. 

Bodies which satisfy the assessment criteria laid down in the applicable harmonised standards 
shall be presumed to satisfy 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  ⌦ set  out  in  Annex  V ⌫  .  It  shall  immediately  inform  the 
Commission and the other Member States accordingly. 

(cid:208) 90/396/CE (adapted) 

(cid:208) 90/396/EEC 
(cid:206)1 93/68/EEC Art. 10 pt. 1 

CHAPTER 3  

(cid:206)1 CE conformity marking  

(cid:208) 90/396/CE 
(cid:206)1 93/68/EEC Art. 10 pt. 1 

Article 10 

1.  The  (cid:206)1 CE  conformity  marking   and  the  inscriptions  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. 

2. The affixing of markings on the appliances which are likely to deceive third parties as to 
the  meaning  and  form  of  the  CE  marking  shall  be  prohibited.  Any  other  marking  may  be 
affixed to the appliance or to the data plate provided that the visibility and legibility of the CE 
marking is not thereby reduced. 

(cid:208) 93/68/EEC Art. 10 pt. 5 

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Without prejudice to Article 7: 

Article 11 

(cid:208) 93/68/EEC Art. 10 pt. 6 

(a) 

(b) 

(cid:208) 93/68/EEC Art.10 pt. 6 
(adapted) 

where a Member State establishes that the CE marking has been affixed unduly, the 
manufacturer or his authorised representative established within the Community shall 
be  obliged  to  make  the  ⌦ appliance ⌫  comply  as  regards  the  provisions 
concerning the CE marking and to end the infringement under conditions imposed by 
⌦ that ⌫ Member State; 

(cid:208) 93/68/EEC Art. 10 pt. 6 

where  non-compliance  continues,  the  Member  State  must  take  all  appropriate 
measures to restrict or prohibit the placing on the market of the appliance in question 
or to ensure that it is withdrawn from the market in accordance with the procedure 
laid down in Article 7. 

(cid:208) 90/396/EEC 

CHAPTER 4  

Final provisions 

Article 12 

Any decision taken pursuant to this Directive which includes restriction on the placing on the 
market and/or putting into service of an appliance shall state the precise grounds on which it 
is based. It 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. 

EN 

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(cid:208) 90/396/EEC 

Article 13 

Member States shall communicate to the Commission the texts of the ⌦ main ⌫ provisions 
of national law which they adopt in the field covered by this Directive. 

(cid:208) 90/396/EEC (adapted) 

(cid:208)  

Article 14 

Directive 90/396/EEC, as amended by the Directive listed in Annex VI, Part A, is repealed, 
without  prejudice  to  the  obligations  of  the  Member  States  relating  to  the  time-limits  for 
transposition into national law and application of the Directives set out in Annex VI, Part B. 

References  to  the  repealed  Directive  shall  be  construed  as  references  to  this  Directive  and 
shall be read in accordance with the correlation table in Annex VII. 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 15 

(cid:208) 90/396/EEC 

Article 16 

This Directive is addressed to the Member States. 

Done at Brussels, […] 

For the European Parliament 
The President 

For the Council 
The President 

EN 

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(cid:208) 90/396/EEC 

ANNEX I 

ESSENTIAL REQUIREMENTS 

PRELIMINARY REMARK 

The  obligations  resulting  from  the  essential  requirements  for  appliances  in  this  Annex  also 
apply to fittings where the corresponding risk exists. 

1. 

GENERAL CONDITIONS 

1.1. 

Appliances must be so designed and built as to operate safely and present no danger 
to  persons,  domestic  animals  or  property  when  normally  used  as  defined  in 
Article 1(3) of this Directive. 

1.2.  When placed on the market, all appliances must: 

– 

– 

– 

be accompanied by technical instructions intended for the installer, 

be accompanied by instructions for use and servicing, intended for the user, 

bear appropriate warning notices, which must also appear on the packaging. 

The instructions and warning notices must be in the official language or languages of 
the Member States of destination. 

1.2.1.  The technical instructions intended for the installer must contain all the instructions 
for installation, adjustment and servicing required to ensure that those operations are 
correctly  performed  and  that  the  appliance  may  be  used  safely.  In  particular,  the 
instructions must specify: 

– 

– 

– 

– 

– 

the type of gas used, 

the gas supply pressure used, 

the flow of fresh air required: 

– 

– 

for the combustion air supply, 

to  avoid  the  formation  of  dangerous  unburned  gas  mixtures  for 
appliances not fitted with the device referred to in point 3.2.3, 

the conditions for the dispersal of combustion products, 

for  forced  draught  burners  and  heating  bodies  intended  to  be  equipped  with 
such  burners,  their  characteristics,  the  requirements  for  assembly,  to  assist 
compliance  with  the  essential  requirements  applicable  to  finished  appliances 

EN 

17 

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and,  where  appropriate,  the  list  of  combinations  recommended  by  the 
manufacturer. 

1.2.2.  The  instructions  for  use  and  servicing  intended  for  the  user  must  contain  all  the 
information required for safe use, and must in particular draw the user's attention to 
any restrictions on use. 

1.2.3.  The warning notices on the appliance and its packaging must clearly state the type of 
gas  used,  the  gas  supply  pressure  and  any  restrictions  on  use,  in  particular  the 
restriction  whereby  the  appliance  must  be  installed  only  in  areas  where  there  is 
sufficient ventilation. 

1.3. 

Fittings intended to be part of an appliance must be so designed and built as to fulfil 
correctly  their  intended  purpose  when  incorporated  in  accordance  with  the 
instructions for installation. 

The  instructions  for  installation,  adjustment,  operation  and  maintenance  must  be 
provided with the fittings concerned. 

2. 

MATERIALS 

2.1. 

Materials  must  be  appropriate  for  their  intended  purpose  and  must  withstand  the 
technical,  chemical  and  thermal  conditions  to  which  they  will  foreseeably  be 
subjected. 

2.2. 

The properties of materials that are important for safety must be guaranteed  by the 
manufacturer or the supplier of the appliance. 

3. 

DESIGN AND CONSTRUCTION 

3.1. 

General 

3.1.1.  Appliances  must  be  so  constructed  that,  when  used  normally,  no  instability, 

distortion, breakage or wear likely to impair their safety can occur. 

3.1.2.  Condensation produced at the start-up and/or during use must not affect the safety of 

appliances. 

3.1.3.  Appliances must be so designed and constructed as to minimise the risk of explosion 

in the event of a fire of external origin. 

3.1.4.  Appliances must be so constructed that water and inappropriate air penetration into 

the gas circuit does not occur. 

3.1.5. 

In the event of a normal fluctuation of auxiliary energy, appliances must continue to 
operate safely. 

3.1.6.  Abnormal fluctuation or failure of auxiliary energy or its restoration must not lead to 

an unsafe situation. 

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3.1.7.  Appliances  must  be  so  designed  and  constructed  as  to  obviate  hazards  of  electrical 
origin.  In  the  area  in  which  it  applies,  compliance  with  the  safety  objectives  in 
respect  of  electrical  hazards  laid  down  in  Directive  2006/95/EC  of  the  European 
Parliament and of the Council1 shall be equivalent to fulfilment of this requirement. 

3.1.8.  All  pressurised  parts  of  an  appliance  must  withstand  the  mechanical  and  thermal 
stresses to which they are subjected without any deformation affecting safety. 

3.1.9.  Appliances must be so designed and constructed that failure of a safety, controlling 

or regulating device may not lead to an unsafe situation. 

3.1.10.  If an appliance is equipped with safety and controlling devices, the functioning of the 

safety devices must not be overruled by that of the controlling devices. 

3.1.11.  All  parts  of  appliances  which  are  set  or  adjusted  at  the  stage  of  manufacture  and 
which  should  not  be  manipulated  by  the  user  or  the  installer  must  be  appropriately 
protected. 

3.1.12.  Levers  and  other  controlling  and  setting  devices  must  be  clearly  marked  and  give 
appropriate instructions so as to prevent any error in handling. Their design must be 
such as to preclude accidental manipulation. 

3.2. 

Unburned gas release 

3.2.1.  Appliances must be so constructed that the gas leakage rate is not dangerous. 

3.2.2.  Appliances  must  be  so  constructed  that  gas  release  during  ignition  and  re-ignition 
and after flame extinction is limited in order to avoid a dangerous accumulation of 
unburned gas in the appliance. 

3.2.3.  Appliances  intended  to  be  used  in  indoor  spaces  and  rooms  must  be  fitted  with  a 
special  device  which  avoids  a  dangerous  accumulation  of  unburned  gas  in  such 
spaces or rooms. 

Appliances which are not fitted with such devices must be used only in areas where 
there is sufficient ventilation to avoid a dangerous accumulation of unburned gas. 

Member States may define on their territory adequate space ventilation conditions for 
the installation of such appliances, bearing in mind the features peculiar to them. 

Large-scale  kitchen  appliances  and  appliances  powered  by  gas  containing  toxic 
components must be equipped with the aforesaid device. 

3.3. 

Ignition 

Appliances must be so constructed that, when used normally: 

– 

– 

ignition and re-ignition is smooth, 

cross-lighting is assured. 

1 

OJ L 374, 27.12.2006, p. 10. 

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3.4. 

Combustion 

3.4.1.  Appliances  must  be  so  constructed  that,  when  used  normally,  flame  stability  is 
assured  and  combustion  products  do  not  contain  unacceptable  concentrations  of 
substances harmful to health. 

3.4.2.  Appliances  must  be  so  constructed  that,  when  used  normally,  there  will  be  no 

accidental release of combustion products. 

3.4.3.  Appliances connected to a flue for the dispersal of combustion products must be so 
constructed  that  in  abnormal  draught  conditions  there  is  no  release  of  combustion 
products in a dangerous quantity into the room concerned. 

3.4.4. 

Independent  flueless  domestic  heating  appliances  and  flueless  instantaneous  water 
heaters  must  not  cause,  in  the  room  or  space  concerned,  a  carbon  monoxide 
concentration likely to present a danger to the health of persons exposed, bearing in 
mind the foreseeable duration of their exposure. 

3.5. 

Rational use of energy 

Appliances must be so constructed as to ensure rational use of energy, reflecting the 
state of the art and taking into account safety aspects. 

3.6. 

Temperatures 

3.6.1.  Parts of appliances which are intended to be placed in close proximity to the floor or 
other surfaces must not reach temperatures which present a danger in the surrounding 
area. 

3.6.2.  The  surface  temperature  of  knobs  and  levers  of  appliances  intended  to  be 

manipulated must not present a danger to the user. 

3.6.3.  The surface temperatures of external parts of appliances intended for domestic use, 
with the exception of surfaces or parts which are associated with the transmission of 
heat,  must  not  under  operating  conditions  present  a  danger  to  the  user  and  in 
particular  to  children,  for  whom  an  appropriate  reaction  time  must  be  taken  into 
account. 

3.7. 

Foodstuffs and water used for sanitary purposes 

Without  prejudice  to  the  Community  rules  in  this  area,  materials  and  components 
used in the construction of an appliance, which may come into contact with food or 
water used for sanitary purposes, must not impair their quality. 

_______________ 

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(cid:208) 90/396/EEC 

ANNEX II 

PROCEDURE FOR CERTIFICATION OF CONFORMITY 

1. 

EC TYPE-EXAMINATION 

1.1. 

1.2. 

The  EC  type-examination  is  that  part  of  the  procedure  by  which  a  notified  body 
checks  and  certifies  that  an  appliance,  representative  of  the  production  envisaged, 
meets the provisions of this Directive which apply to it. 

The  application  for  type-examination  must  be  lodged  by  the  manufacturer  or  his 
authorised  representative  established  within  the  Community  with  a  single  notified 
body. 

1.2.1.  The application must include: 

– 

– 

– 

the name and address of the manufacturer and, if the application is lodged by 
the authorised representative, his name and address, 

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  must  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 if needed for the test programme. 

The type may additionally cover variants of the product provided that those variants 
do not have different characteristics with respect to types of risk. 

1.3. 

The notified body must: 

1.3.1. 

1.3.2. 

1.3.3. 

examine the design documentation and verify that the type has been manufactured in 
conformity  with  the  design  documentation  and  identify  the  elements  which  have 
been designed in accordance with the applicable provisions of the standards referred 
to in Article 5 and the essential requirements of this Directive; 

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; 

perform,  or  have  performed,  the  appropriate  examinations  and/or  tests  to  check 
whether  the  applicable  standards  have  effectively  been  applied  where  the 
manufacturer  has  chosen  to  do  so,  thereby  assuring  conformity  with  the  essential 
requirements. 

EN 

21 

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1.4.  Where the type satisfies the provisions of this Directive, the notified body must issue 
an EC type-examination certificate to the applicant. The certificate must contain the 
conclusions  of  the  examination,  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 diagrams must be 
annexed to the certificate. 

1.5. 

1.6. 

1.7. 

The notified body must inform the other notified bodies forthwith of the issuing of 
the EC type-examination certificate and any additions to the said type as referred to 
in point 1.7. They may obtain a copy of the EC type-examination 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. 

A  notified  body  which  refuses  to  issue  or  withdraws  an  EC  type-examination 
certificate  must  inform  the  Member  State  which  notified  it  and  the  other  notified 
bodies accordingly, giving the reasons for its decision. 

The applicant must keep the notified body that has issued the EC type-examination 
certificate  informed  of  all  modifications  to  the  approved  type  which  might  affect 
conformity with the essential requirements. 

Modifications  to  the  approved  type  must  receive  additional  approval  from  the 
notified  body  that  issued  the  EC  type-examination  certificate  where  such  changes 
affect conformity with the essential requirements or the prescribed conditions for use 
of the appliance. This additional approval is to be given in the form of an addition to 
the original EC type-examination certificate. 

(cid:208) 90/396/EC  
(cid:206)1 93/68/EEC Art.10 pt. 7 

2. 

EC DECLARATION OF CONFORMITY TO TYPE 

2.1. 

The EC declaration of conformity to type 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-examination  certificate  and  satisfy  the  essential 
requirements  of  this  Directive  which  apply  to  them.  (cid:206)1 The  manufacturer  or  his 
authorised  representative  established  within  the  Community  shall  affix  the  CE 
marking on each appliance and draw up a written certificate of conformity.  The 
declaration of conformity may cover one or more appliances and must be kept by the 
manufacturer. (cid:206)1 The CE marking must be followed by the identification number of 
the notified body responsible for the random checks set out in point 2.3.  

2.2. 

The manufacturer must take all necessary measures to ensure that the manufacturing 
process,  including  final  product  inspection  and  testing,  results  in  homogeneity  of 
production  and  conformity  of  the  appliances  with  the  type  as  described  in  the  EC 
type-examination certificate and with the requirements of this Directive which apply 

(cid:208) 90/396/EC 

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to them. A notified body, chosen by the manufacturer, must carry out random checks 
on the appliances as set out in point 2.3. 

2.3. 

On-site checks of appliances must be undertaken at random by the notified body at 
intervals of one year or less. An adequate number of  appliances must  be  examined 
and appropriate tests as set out in the applicable standards referred to in Article 5 or 
equivalent  tests  must  be  carried  out  in  order  to  ensure  conformity  with  the 
corresponding  essential  requirements  of  this  Directive.  The  notified  body  shall  in 
each  case  determine  whether  these  tests  need  to  be  carried  out  in  full  or  in  part. 
Where  one  or  more  appliances  are  rejected,  the  notified  body  shall  take  the 
appropriate measures to prevent the marketing thereof. 

3. 

EC  DECLARATION  OF  CONFORMITY  TO  TYPE 
PRODUCTION QUALITY) 

(GUARANTEE  OF 

(cid:208) 90/396/EC 
(cid:206)1 93/68/EEC Art.10 pt. 7 

3.1. 

The  EC  declaration  of  conformity  to  type  (guarantee  of  production  quality)  is  the 
procedure  whereby  a  manufacturer  who  fulfils  the  obligations  in  point  3.2  declares 
that the appliances concerned are in conformity with the type as described in the EC 
type-examination  certificate  and  satisfy  the  essential  requirements  of  this  Directive 
which  applies  to  them.  (cid:206)1 The  manufacturer  or  his  authorised  representative 
established within the Community must affix the CE marking to each appliance and 
draw  up  a  written  declaration  of  conformity.   This  declaration  may  cover  one  or 
more appliances and must be kept by the manufacturer. (cid:206)1 The CE marking must be 
followed  by  the  identification  number  of  the  notified  body  responsible  for  EC 
surveillance.  

3.2. 

The  manufacturer  shall  apply  a  quality  system  that  ensures  conformity  of  the 
appliances with the type as described in the EC type-examination certificate and with 
the essential requirements of this Directive which apply to them. The manufacturer is 
subject to EC surveillance as specified in point 3.4. 

(cid:208) 90/396/EC 

3.3. 

Quality system 

3.3.1.  The manufacturer must lodge an application for approval of his quality system with a 

notified body of his choice for the appliances in question. 

The application must include: 

– 

– 

the quality system documentation, 

an undertaking to carry out the obligations arising from the quality system as 
approved, 

EN 

23 

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– 

– 

an undertaking to maintain the approved quality system to ensure its continuing 
suitability and effectiveness, 

documentation  relating  to  the  approved  type  and  a  copy  of  the  EC 
type-examination certificate. 

3.3.2.  All the elements, requirements and provisions adopted by the manufacturer must be 
documented in a systematic and logical manner in the form of measures, procedures 
and  written  instructions.  This  quality  system  documentation  must  permit  a  uniform 
interpretation of the quality programmes, plans, manuals and records. It shall contain, 
in particular, an adequate description of: 

– 

– 

– 

– 

the  quality  objectives,  the  organisational  structure  and  responsibilities  of 
management and of their powers with regard to appliance 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 method of monitoring attainment of the required appliance 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  point  3.3.2.  It  will  presume 
conformity with these requirements in respect of quality systems that implement the 
corresponding harmonised standard. 

It must notify its decision to the manufacturer and inform the  other notified bodies 
thereof.  The  notification  to  the  manufacturer  must  contain  the  conclusions  of  the 
examination, the name and address of the notified body and the reasoned assessment 
decision in respect of the appliances concerned. 

3.3.4.  The manufacturer must 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, for example, new technologies and quality concepts. 

The notified body must examine the proposed modifications and decide whether the 
modified quality system complies with the relevant provisions or whether reappraisal 
is  necessary.  It  must  notify  the  manufacturer  of  its  decision.  The  notification  must 
include the conclusions of the inspection and the reasoned assessment decision. 

3.3.5.  A notified body that withdraws approval of a quality system must 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  ensure  that  the  manufacturer  duly  fulfils  the 

obligations arising out of the approved quality system. 

EN 

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3.4.2.  The manufacturer must allow the notified body access for inspection purposes to the 
place  of  manufacture,  inspection,  testing  and  storage  and  must  provide  it  with  all 
necessary information, in particular: 

– 

– 

the quality system documentation, 

the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 
reports on qualifications of the staff concerned, etc. 

3.4.3.  The notified body must carry out a check at least once every two years to ensure that 
the manufacturer is maintaining and applying the approved quality system and must 
supply a report of the check to the manufacturer. 

3.4.4.  Furthermore,  the  notified  body  may  make  unannounced  visits  to  the  manufacturer. 
During these visits, the notified body may carry out tests on appliances or have them 
carried  out.  It  must  supply  the  manufacturer  with  an  inspection  report  and,  if 
appropriate, a test report. 

3.4.5.  The manufacturer may supply the notified body's report on request. 

4. 

EC  DECLARATION  OF  TYPE  CONFORMITY  (GUARANTEE  OF  PRODUCT 
QUALITY) 

(cid:208) 90/396/EC  
(cid:206)1 93/68/EEC Art.10 pt. 7 

4.1. 

The EC declaration of type conformity (guarantee of product quality) is that part of 
the  procedure  whereby  a  manufacturer  who  fulfils  the  obligations  in  point  4.2 
declares that the appliances concerned are in conformity with the type as described in 
the  EC  type-examination  certificate  and  satisfy  the  essential  requirements  of  this 
Directive which apply to them. (cid:206)1 The manufacturer or his authorised representative 
established within the Community must affix the CE marking to each appliance and 
draw  up  a  written  declaration  of  conformity.   This  declaration  may  cover  one  or 
more appliances and must be kept by the manufacturer. (cid:206)1 The CE marking must be 
followed  by  the  identification  number  of  the  notified  body  responsible  for  EC 
surveillance.  

4.2. 

The manufacturer shall apply an approved quality system for the final inspection of 
the  appliances  and  the  tests,  as  specified  in  point  4.3,  and  is  subject  to  EC 
surveillance as specified in point 4.4. 

(cid:208) 90/396/EC 

4.3. 

Quality system 

4.3.1.  Under this procedure, the manufacturer must lodge an application for approval of his 

quality system with a notified body of his choice for the appliances in question. 

The application must include: 

EN 

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– 

– 

– 

– 

the quality system documentation, 

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, 

the  documentation  relating  to  the  approved  type  and  a  copy  of  the  EC 
type-examination certificate. 

4.3.2.  As part of the quality system, each appliance must be examined and appropriate tests 
as laid down in the applicable standard(s) referred to in Article 5 or equivalent tests 
carried  out  to  check  its  conformity  with  the  essential  requirements  relating  to  it  in 
this Directive. 

All the elements, requirements and provisions adopted by the manufacturer must be 
documented in a systematic and logical manner in the form of measures, procedures 
and  written  instructions.  This  quality  system  documentation  must  permit  a  uniform 
interpretation of the quality programmes, plans, manuals and records. 

The  quality  system  documentation  shall  contain,  in  particular,  an  adequate 
description of: 

– 

– 

– 

the  quality  objectives,  the  organisational  structure  and  responsibilities  of 
management and of their powers with regard to appliance quality, 

the checks and tests to be carried out after manufacture, 

the method of verifying the effective operation of the quality system. 

4.3.3.  The  notified  body  shall  examine  and  evaluate  the  quality  system  to  determine 
whether  it  satisfies  the  requirements  referred  to  in  point  4.3.2.  It  will  presume 
conformity with these requirements in respect of quality systems that implement the 
corresponding  harmonised  standard.  It  must  notify  the  manufacturer  of  its  decision 
and  inform  the  other  notified  bodies  thereof.  The  notification  to  the  manufacturer 
must  contain  the  conclusions  of  the  examination,  the  name  and  address  of  the 
notified body and the reasoned assessment decision for the appliances concerned. 

4.3.4.  The  manufacturer  must  keep  the  notified  body  which  approved  the  quality  system 
informed  of  any  adaptation  of  the  quality  system  made  necessary,  e.g.  by  new 
technology and quality concepts. 

The  notified  body  must  examine  the  proposed  changes  and  decide  whether  the 
amended quality system satisfies the relevant provisions or whether a reassessment is 
necessary.  It  must  notify  the  manufacturer  of  its  decision.  The  notification  must 
contain the conclusions of the inspection and the reasoned assessment decision. 

4.3.5.  A notified body which withdraws approval of a quality system must inform the other 

notified bodies that it has done so and give reasons for its decision. 

EN 

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4.4. 

EC surveillance 

4.4.1.  The  purpose  of  EC  surveillance  is  to  ensure  that  the  manufacturer  duly  fulfils  the 

obligations arising out of the approved quality system. 

4.4.2.  The manufacturer must allow the notified body access for inspection to the place of 
inspection, testing and storage and must provide it with all necessary information, in 
particular: 

– 

– 

the quality system documentation, 

the quality files such as inspection reports and test data, calibration data, report 
on qualifications of the staff concerned, etc. 

4.4.3.  The notified body must carry out a check at least once every two years to ensure that 
the manufacturer is maintaining and applying the approved quality system and must 
supply a report on the check to the manufacturer. 

4.4.4.  Furthermore,  the  notified  body  may  make  unannounced  visits  to  the  manufacturer. 
During these visits, the body may carry out tests on appliances or have them carried 
out. It must supply the manufacturer with an inspection report and, if appropriate, a 
test report. 

4.4.5.  The manufacturer may supply the notified body's report on request. 

(cid:208) 93/68/EEC Art.10 pt. 7 

5. 

EC VERIFICATION 

5.1. 

5.2. 

EC  verification  is  the  procedure  whereby  the  manufacturer  or  his  authorised 
representative  established  within  the  Community  ensures  and  declares  that  the 
appliances  subject  to  the  provisions  of  point  3  are  in  conformity  to  the  type  as 
described  in  the  EC  type-examination  certification  and  satisfy  the  requirements  of 
this Directive that apply to them. 

The manufacturer or his authorised representative established within the Community 
must  take  all  measures  necessary  in  order  that  the  manufacturing  process  ensures 
conformity  of  the  appliances  to  the  type  as  described  in  the  EC  type-examination 
certification  and  to  the  requirements  of  this  Directive  that  apply  to  them.  The 
manufacturer  or  his  authorised  representative  established  within  the  Community 
must  affix  the  CE  marking  to  each  appliance  and  draw  up  a  written  declaration  of 
conformity.  The  declaration  of  conformity  may  cover  one  or  more  appliances  and 
must be kept by the manufacturer or his authorised representative established within 
the Community. 

5.3. 

The notified body must carry out the appropriate examinations and tests in order to 
check  the  conformity  of  the  appliance  to  the  requirements  of  this  Directive  by 
examination  and  testing  of  every  appliance,  as  specified  in  point  5.4,  or  by 
examination and testing of appliances on a statistical basis, as specified in point 5.5, 
at the choice of the manufacturer. 

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5.4. 

Verification by checking and testing of each appliance 

5.4.1.  All appliances must be individually examined and appropriate tests, as set out in the 
relevant standard(s) referred to in Article 5, or equivalent tests, must be carried out in 
order  to  verify  their  conformity  with  the  type  as  described  in  the  EC  type-
examination certificate and the requirements of this Directive that apply to them. 

5.4.2.  The  notified  body  must  affix,  or  cause  to  be  affixed,  its  identification  number  on 
each  appliance  and  draw  up  a  written  certificate  of  conformity  relating  to  the  tests 
carried out. The certificate of conformity may cover one or more appliances. 

5.4.3.  The  manufacturer  or  his  authorised  representative  must  ensure  that  he  is  able  to 

supply the notified body's certificates of conformity on request. 

5.5. 

Statistical verification 

5.5.1.  Manufacturers  must  present  the  appliances  manufactured  in  the  form  of  uniform 
batches and must take all necessary measures in order that the manufacturing process 
ensures the uniformity of each batch produced. 

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5.5.2.  Statistical control is as follows: 

Appliances  are  subject  to  statistical  control  by  attributes.  They  should  be  grouped 
into identifiable batches consisting of units of a single model manufactured under the 
same  conditions.  A  batch  is  examined  at  random  intervals.  The  appliances 
constituting a sample are examined individually and appropriate tests, as laid down 
in  the  respective  standard(s)  referred  to  in  Article  5,  or  equivalent  tests  are  carried 
out to determine whether the batch is to be accepted or rejected. 

A sampling system with the following characteristics is applied: 

– 

– 

a level of quality corresponding to a probability of acceptance of 95%, with a 
non-conformity percentage of between 0,5 and 1,5%, 

a  limit  quality  corresponding  to  a  probability  of  acceptance  of  5%,  with  a 
percentage of non-conformity of between 5 and 10%. 

5.5.3.  Where batches are accepted, the notified body must affix, or cause to be affixed, its 
identification  number  to  each  appliance  and  draw  up  a  written  certificate  of 
conformity relating to the tests carried out. All appliances in the batch may be placed 
on the market except for those products from the sample which were found not to be 
in conformity. 

Where  a  batch  is  rejected,  the  notified  body  must  take  appropriate  measures  to 
prevent the placing on the market of that batch. In the event of frequent rejection of 
batches the notified body may suspend the statistical verification. 

The manufacturer may, under the responsibility of the notified body, affix the latter's 
identification number during the manufacturing process. 

5.5.4.  The  manufacturer  or  his  authorised  representative  must  ensure  that  he  is  able  to 

supply the notified body's certificates of conformity on request. 

6. 

EC UNIT VERIFICATION 

6.1. 

EC  unit  verification  is  the  procedure  whereby  the  manufacturer  or  his  authorised 
representative  established  within  the  Community  ensures  and  declares  that  the 
appliance concerned, which has been issued with the certificate referred to in point 2, 
conforms to the requirements of this Directive that apply to it. The manufacturer or 
his authorised representative must affix the CE marking to the appliance and draw up 
a written declaration of conformity which he must keep. 

6.2. 

The  notified  body  must  examine  the  appliance  and  carry  out  the  appropriate  tests, 
taking account of the design documentation in order to ensure its conformity with the 
essential requirements of this Directive. 

The notified body must affix, or cause to be affixed, its identification number to the 
approved appliance and must draw up a written certificate of conformity concerning 
the tests carried out. 

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6.3. 

6.4. 

6.5. 

The aim of the technical documentation relating to the design of the instrument, as 
referred to in Annex IV, is to enable conformity to the requirements of this Directive 
to  be  assessed  and  the  design,  manufacture  and  operation  of  the  appliance  to  be 
understood. 

The  design  documentation  referred  to  in  Annex  IV  must  be  made  available  to  the 
notified body. 

If deemed necessary by the notified body, the examinations and tests may be carried 
out after installation of the appliance. 

The  manufacturer  or  his  authorised  representative  must  ensure  that  he  is  able  to 
supply the notified body's certificates of conformity on request. 

________________ 

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(cid:208) 93/68/EEC Art.10 pt. 8 

ANNEX III 

CE CONFORMITY MARKING AND INSCRIPTIONS 

1. 

The CE conformity marking consists of the initials “CE” as shown below: 

The CE marking must be followed by the identification number of the notified body 
involved in the production control phase. 

2. 

The appliance or its data plate must bear the CE marking together with the following 
inscriptions: 

– 

– 

– 

– 

– 

the manufacturer's name or identification symbol, 

the trade name of the appliance, 

the type of electrical supply used, if applicable, 

the appliance category, 

the last two digits of the year in which the CE marking was affixed. 

Information needed for installation purposes may be added according to the nature of 
the appliance. 

3. 

If  the  CE  marking  is  reduced  or  enlarged  the  proportions  given  in  the  above 
graduated drawing must be respected. 

The various components of the CE marking must have substantially the same vertical 
dimension, which may not be less than 5 mm. 

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(cid:208) 90/396/EEC 

ANNEX IV 

DESIGN DOCUMENTATION 

The design documentation must contain the following information, in so far as is required by 
the notified body for assessment: 

– 

– 

– 

– 

– 

– 

a general description of the appliance, 

conceptual  designs  and  manufacturing  drawings  and  diagrams  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, 

manuals for installation and use. 

Where appropriate, the design documentation must contain the following elements: 

– 

– 

– 

attestations relating to the equipment incorporated in the appliance, 

attestations and certificates relating to the methods of manufacture and/or inspection 
and/or monitoring of the appliance, 

any  other  document  making  it  possible  for  the  notified  body  to  improve  its 
assessment. 

________________ 

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(cid:208) 90/396/EEC 

ANNEX V 

MINIMUM CRITERIA FOR ASSESSMENT 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  reports,  issuing  certificates  and 
performing  the  surveillance  provided  for  in  this  Directive,  of  management  and 
technical  staff  in  relation  to  all  circles,  groups  or  persons  directly  or  indirectly 
involved in the field of the appliances, 

maintenance of professional secrecy by staff, 

possession  of  civil  liability  insurance  unless  that  liability  is  covered  by  the  State 
under national law. 

Fulfilment  of  the  conditions  in  the  first  two  indents  must  be  periodically  verified  by  the 
competent authorities of the Member States or by bodies designated by the Member States. 

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(cid:207) 

ANNEX VI 

Part A 

Repealed Directive with its amendment 
(referred to in Article 14) 

Council Directive 90/396/EEC 
(OJ L 196, 26.7.1990, p. 15) 

Council Directive 93/68/EEC 
(OJ L 220, 30.8.1993, p. 1) 

Article 10 only 

Part B 

List of time-limits for transposition into national law and application 
(referred to in Article 14) 

Directive 

Time-limit for transposition 

Date of application 

90/396/EEC 

93/68/EEC 

30.6.1991 

30.6.1994 

1.1.1992 

1.1.1995 

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ANNEX VII 

CORRELATION TABLE 

Directive 90/396/EEC 

This Directive 

Article 1(1), introductory wording  

Article 1(1) first subparagraph 

Article 1(1), first and second indents 

Article 1(2)(a) and (b) 

Article 1(2) 

Article 1(1) second subparagraph 

Recital 8, last sentence 

Article 1(3) 

Article 1(4) 

Article 2(1) 

Article 1(2)(c) 

Article 1(2)(d) 

Article 1(3) 

Article 2(1) 

Article 2(2) first and second sentences 

Article 2(2) first subparagraph 

Article 2(2) third sentence 

Article 2(2) second subparagraph 

Articles 3 and 4 

Articles 3 and 4 

Article 5(1)(a) first subparagraph 

Article 5(1)(a) 

Article 5(1)(a) second subparagraph 

Article 5(2) first subparagraph 

Article 5(1)(b) 

Article 5(1)(b) 

Article 5(2), first sentence 

Article 5(2), second subparagraph 

Article 5(2), third sentence 

Article 5(2), third subparagraph 

Article  6(1), 
sentence 

first 

subparagraph, 

first 

Article 6(1), first subparagraph 

Article  6(1),  first  subparagraph,  second 
sentence 

Article 6(1), second subparagraph 

Article 6(1), second subparagraph 

Article 6(1), third subparagraph 

Article 6(2), first sentence 

Article 6(2), first subparagraph 

Article 6(2), second sentence 

Article 6(2), second subparagraph 

Article 6(2), third sentence 

Article 6(2), third subparagraph 

Article 7 

Article 7 

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Article 8(1)(a) 

Article 8(1)(a) 

Article 8(1)(b), introductory wording 

Article 8(1)(b), introductory wording 

Article 8(1)(b), first to fourth indents 

Article 8(1)(b)(i) to (iv) 

Article 8(2) and (3) 

Article 8(2) and (3) 

Article 8(4), first subparagraph first sentence  Article 8(4), first subparagraph 

Article  8(4),  first  subparagraph  second 
sentence 

Article 8(4), second subparagraph 

Article 8(4), second subparagraph 

Article 8(4), third subparagraph 

Article 8(5)(a) 

Article 8(5)(b) 

Article 8(6) 

Articles 9 to12 

Article 13 

Article 14(1) and (2) 

Article 14(3) 

– 

– 

Article 15 

Annexes I to V 

_ 

_ 

Article 8(5), first subparagraph 

Article 8(5), second subparagraph 

Article 8(6) 

Articles 9 to 12 

– 

– 

Article 13 

Article 14 

Article 15 

Article 16 

Annexes I to V 

Annex VI 

Annex VII 

_________________________ 

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