Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the  harmonisation of the laws of the Member States  relating to  equipment and protective systems intended for use in potentially explosive atmospheres
Date: 2011-11-21
Institutions: European Commission
Subjects: EC conformity marking, approximation of laws, industrial hazard, launching of a product, market supervision, marketing standard, mining extraction, product safety, safety standard, surveillance concerning imports, technical standard

EUROPEAN COMMISSION 

Brussels, 21.11.2011 
COM(2011) 772 final 

2011/0356 (COD) 

NEW LEGISLATIVE FRAMEWORK (NLF) ALIGNMENT PACKAGE 
(Implementation of the Goods Package) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the  harmonisation of the laws of the Member States  relating to  equipment and 
protective systems intended for use in potentially explosive atmospheres 

(Recast) 

(Text with EEA relevance) 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

General context, reasons for and objectives of this proposal 

This proposal is presented in the framework of the implementation of the “goods package” 
adopted  in  2008.  It  is  part  of  a  package  of  proposals  aligning  ten  product  directives  to 
Decision No 768/2008/EC establishing a common framework for the marketing of products. 

Union (EU) harmonisation legislation ensuring the free movement of products has contributed 
considerably to the completion and operation of the Single Market. It is based on a high level 
of  protection  and  provides  economic  operators  with  the  means  to  demonstrate  conformity, 
thus ensuring free movement through trust in the products. 

Directive  94/9/EC  (the  ATEX  Directive)  is  an  example  of  that  Union  harmonisation 
legislation, ensuring the free movement of products. It sets out the essential health and safety 
requirements that products must comply with in order to be made available on the EU market. 
Manufacturers  must  demonstrate  that  a  product  has  been  designed  and  manufactured  in 
compliance with the essential health and safety requirements and affix the CE marking.  

Experience  with  the  implementation  of  Union  harmonisation  legislation  has  shown  –  on  a 
cross-sector  scale  -  certain  weaknesses  and  inconsistencies  in  the  implementation  and 
enforcement of this legislation, leading to 

–  the  presence  of  non-compliant  or  dangerous  products  on  the  market  and  consequently  a 

certain lack of trust in CE marking, 

–  competitive  disadvantages  for  economic  operators  complying  with  the  legislation  as 

opposed to those circumventing the rules, 

–  unequal  treatment  in  the  case  of  non-compliant  products  and  distortion  of  competition 

amongst economic operators due to different enforcement practices, 

–  differing  practices  in  the  designation  of  conformity  assessment  bodies  by  national 

authorities, and 

–  problems with the quality of certain notified bodies. 

Furthermore the regulatory environment has become more and more complex, as frequently 
several  pieces  of 
the  same  product. 
Inconsistencies  in  these  pieces  of  legislation  make  it  increasingly  difficult  for  economic 
operators and authorities to correctly interpret and apply that legislation. 

legislation  apply  simultaneously 

to  one  and 

To remedy these horizontal shortcomings in Union harmonisation legislation observed across 
several industrial sectors, the "New Legislative Framework" was adopted in 2008 as part of 
the  goods  package.  Its  objective  is  to  strengthen  and  complete  the  existing  rules  and  to 
improve  practical  aspects  of  their  application  and  enforcement.  The  New  Legislative 
Framework  (NLF)  consists  of  two  complementary  instruments,  Regulation  (EC)  No 
765/2008  on  accreditation  and  market  surveillance  and  Decision  No  768/2008/EC 
establishing a common framework for the marketing of products. 

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The  NLF  Regulation  has  introduced  rules  on  accreditation  (a  tool  for  the  evaluation  of 
competence  of  conformity  assessment  bodies)  and  requirements  for  the  organisation  and 
performance  of  market  surveillance  and  controls  of  products  from  third  countries.  Since  1 
January 2010 these rules apply directly in all Member States. 

The NLF Decision sets out a common framework for EU product harmonisation legislation. 
This  framework  consists  of  the  provisions  which  are  commonly  used  in  EU  product 
legislation  (e.g.  definitions,  obligations  of  economic  operators,  notified  bodies,  safeguard 
mechanisms,  etc).  These  common  provisions  have  been  reinforced  to  ensure  that  the 
directives  can  be  applied  and  enforced  more  effectively  in  practice.  New  elements,  such  as 
obligations on importers, have been introduced, which are crucial for improving the safety of 
products on the market. 

The provisions of the NLF Decision and those of the NLF Regulation are complementary and 
closely  interlinked.  The  NLF  Decision  contains  the  corresponding  obligations  for  economic 
operators  and  notified  bodies  allowing  market  surveillance  authorities  and  authorities 
responsible  for  notified  bodies  to  properly  perform  the  tasks  imposed  on  them  by  the  NLF 
Regulation and to ensure an effective and consistent enforcement of EU product legislation. 

However,  unlike  the  NLF  Regulation,  the  provisions  of  the  NLF  Decision  are  not  directly 
applicable.  To  ensure  that  all  economic  sectors  subject  to  Union  harmonisation  legislation 
benefit  from  the  improvements  of  the  NLF,  the  provisions  of  the  NLF  Decision  need  to  be 
integrated into the existing product legislation. 

A survey after  the adoption  of  the  goods package  in  2008  showed  that  a  majority  of  Union 
harmonisation legislation on products was due to be revised within the following 3 years, not 
only  to  address  the  problems  observed  throughout  all  sectors  but  also  for  sector-specific 
reasons.  Any  such  revision  would  automatically  include  an  alignment  of  the  legislation 
concerned to the NLF Decision since Parliament, Council and Commission have committed 
themselves to use its provisions as much as possible in future legislation on products in order 
to further the utmost coherence of the regulatory framework. 

For  a  number  of  other  Union  harmonisation  directives,  including  Directive  94/9/EC,  no 
revision  for  sector-specific  problems  had  been  envisaged  within  this  timeframe.  To  ensure 
that the problems in relation to non-compliance and notified bodies are nevertheless addressed 
in  these  sectors,  and  for  the  sake  of  consistency  of  the  overall  regulatory  environment  on 
products,  it  was  decided  to  align  these  directives  within  a  package  to  the  provisions  of  the 
NLF Decision. 

Consistency with other policies and objectives of the Union 

This initiative is in line with the Single Market Act1, which has stressed the need to restore 
consumer  confidence  in  the  quality  of  products  on  the  market  and  the  importance  of 
reinforcing market surveillance. 

Furthermore it supports the Commission’s policy on Better Regulation and simplification of 
the regulatory environment. 

1 

Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  Economic  and 
Social Committee and the Committee of the Regions, COM(2011) 206 final. 

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2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

Consultation of interested parties 

The alignment of the ATEX Directive 94/9/EC to the NLF Decision has been discussed with 
national experts responsible for the implementation of this Directive, the notified body group, 
the administrative cooperation group as well as the representatives of industry associations in 
the relevant experts working group. 

From June to October 2010 a public consultation was organised that comprised all the sectors 
involved in this initiative. It consisted of four targeted questionnaires for economic operators, 
authorities, notified bodies and users and the Commission services received 300 replies. The 
results are published at http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-
policies-common-rules-for-products/new-legislative-framework/index_en.htm. 

In addition to the general consultation a specific SME consultation was carried out. 603 SMEs 
were  consulted  through  the  Enterprise  Europe  Network  in  May/June  2010.  The  results  are 
available  at  http://ec.europa.eu/enterprise/policies/single-market-goods/files/new-legislative-
framework/smes_statistics_en.pdf. 

The consultation process revealed widespread support for the initiative. There is unanimity on 
the need to improve market surveillance and the system for assessing and monitoring Notified 
Bodies.  Authorities  fully  support  the  exercise  because  it  will  strengthen  the  existing  system 
and  improve  cooperation  at  EU  level.  Industry  expects  a  more  level  playing  field  resulting 
from more effective actions against products that do not comply with the legislation, as well 
as a simplification effect from the alignment of legislation. Certain concerns were expressed 
on some obligations which are, however, indispensable for increasing the efficiency of market 
surveillance.  These  measures  will  not  entail  significant  costs  for  industry,  and  the  benefits 
resulting from improved market surveillance should by far outweigh the costs. 

Collection and use of expertise 

The  impact  assessment  for  this  implementation  package  has  largely  built  on  the  impact 
assessment  carried  out  for  the  New  Legislative  Framework.  In  addition  to  the  expertise 
collected  and  analysed  in  that  context,  further  consultation  of  sector-specific  experts  and 
interest  groups,  as  well  as  horizontal  experts  active  in  the  area  of  technical  harmonisation, 
conformity assessment, accreditation and market surveillance, has taken place. 

External expertise was used to obtain some basic data on certain sectors: for the ATEX sector, 
the study "Market description, competitiveness analysis in the field of products and protective 
systems 
in  potentially  explosive  atmospheres",  available  on 
http://ec.europa.eu/enterprise/sectors/mechanical/files/atex/atexcomp_finalreport_en.pdf. 

for  use 

intended 

Impact assessment  

Based on the information collected, the Commission carried out an impact assessment which 
examined and compared three options. 

Option 1 – No changes to the current situation 

This  option  proposes  no  changes  to  the  current  directive  and  relies  exclusively  on  certain 
improvements that can be expected from the NLF Regulation. 

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Option 2 – Alignment to the NLF Decision by non-legislative measures 

Option 2 considers the possibility of encouraging a voluntary alignment to the provisions set 
out in the NLF Decision by, e.g., presenting them as best practices in guidance documents. 

Option 3 – Alignment to NLF Decision by legislative measures 

This  option  consists  in  integrating  the  provisions  of  the  NLF  Decision  into  the  existing 
directives. 

Option 3 was found to be the preferred option because 

–  it  will  improve  the  competitiveness  of  companies  and  notified  bodies  taking  their 

obligations seriously, as opposed to those cheating on the system; 

–  it  will  improve  the  functioning  of  the  internal  market  by  ensuring  equal  treatment  of  all 

economic operators, notably importers and distributors, as well as notified bodies; 

–  it  does  not  entail  significant  costs  for  economic  operators  and  notified  bodies;  for  those 
who are already acting responsibly, no extra costs or only negligible costs are expected; 

–  it is considered more effective than option 2: due to the lack of enforceability of option 2 it 

is questionable that the positive impacts would materialise under that option; 

–  options 1 and 2 do not provide answers to the problem of inconsistencies in the regulatory 
framework  and  therefore  have  no  positive  impact  on  the  simplification  of  the  regulatory 
environment. 

3. 

MAIN ELEMENTS OF THE PROPOSAL 

3.1. 

Horizontal definitions 

The  proposal  introduces  harmonised  definitions  of  terms  which  are  commonly  used 
throughout  Union  harmonisation  legislation  and  should  therefore  be  given  a  consistent 
meaning throughout that legislation. 

3.2. 

Obligations of economic operators and traceability requirements 

The  proposal  clarifies  the  obligations  of  manufacturers  and  authorised  representatives  and 
introduces  obligations  for  importers  and  distributors.  Importers  must  verify  that  the 
manufacturer has carried out the applicable conformity assessment procedure and has drawn 
up  a  technical  documentation.  They  must  also  make  sure  with  the  manufacturer  that  this 
technical  documentation  can  be  made  available  to  authorities  upon  request.  Furthermore 
importers must verify that the products are correctly marked and accompanied by the required 
documents, instructions and safety information. They must keep a copy of the Declaration of 
conformity and indicate their name and address on the product, or where this is not possible 
on  the  packaging  or  the  accompanying  documentation.  Distributors  must  verify  that  the 
product bears the CE marking, the name of the manufacturer and of the importer, if relevant, 
and that it is accompanied by the required documentation and instructions. 

Importers  and  distributors  must  cooperate  with  market  surveillance  authorities  and  take 
appropriate actions when they have supplied non-compliant products. 

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Enhanced traceability obligations are introduced for all economic operators. Products have 
to bear the manufacturer’s name and address and a number allowing to identify and link the 
product to its technical documentation. When a product is imported the importer’s name and 
address  must  also  be  on  the  product.  Furthermore  every  economic  operator  must  be  able  to 
identify towards authorities the economic operator who has supplied him with a product or to 
whom he has supplied a product. 

3.3. 

Harmonised standards 

Compliance  with  harmonised  standards  provides  a  presumption  of  conformity  with  the 
essential requirements. On 1 June 2011 the Commission adopted a proposal for a Regulation 
on  European  Standardisation2  that  sets  out  a  horizontal  legal  framework  for  European 
standardisation.  The  proposal  for  the  Regulation  contains  inter  alia  provisions  on 
standardisation requests from the Commission to the European Standardisation Organisations, 
on the procedure for objections to harmonised standards and on  stakeholder participation in 
the  standardisation  process.  Consequently  the  provisions  of  Directive  94/9/EC  which  cover 
the same aspects have been deleted in this proposal for reasons of legal certainty. 

The  provisions  conferring  presumption  of  conformity  to  harmonised  standards  have  been 
modified to clarify the extent of the presumption of conformity when standards only partially 
cover the essential requirements. 

3.4. 

Conformity assessment and CE marking 

Directive  94/9/EC  has  selected  the  appropriate  conformity  assessment  procedures  which 
manufacturers  have  to  apply  in  order  to  demonstrate  that  their  products  comply  with  the 
essential  health  and  safety  requirements.  The  proposal  aligns  these  procedures  to  their 
updated versions set out in the NLF Decision. Sector specific elements of the procedures have 
been maintained. 

General principles of the CE marking are set out in Article 30 of Regulation 765/2008, while 
the  detailed  provisions  on  the  affixing  of  the  CE  marking  and  the  specific  marking  of 
explosion protection to products have been inserted in this proposal. 

3.5. 

Notified Bodies 

The  proposal  reinforces  the  notification  criteria  for  notified  bodies.  It  clarifies  that 
subsidiaries or subcontractors must also comply  with the notification requirements. Specific 
requirements  for  notifying  authorities  are  introduced,  and  the  procedure  for  notification  of 
notified  bodies  is  revised.  The  competence  of  a  notified  body  must  be  demonstrated  by  an 
accreditation certificate. Where accreditation has not been used to evaluate the competence of 
a  notified  body,  the  notification  must  comprise  the  documentation  demonstrating  how  the 
competence of that body has been evaluated. Member States will have the possibility to object 
to a notification. 

3.6.  Market surveillance and the safeguard clause procedure 

The  proposal  revises  the  existing  safeguard  clause  procedure.  It  introduces  a  phase  of 
information  exchange  between  Member  States,  and  specifies  the  steps  to  be  taken  by  the 

2 

COM(2011) 315 final. 

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authorities  concerned,  when  a  non-compliant  product  is  found.  A  real  safeguard  clause 
procedure – leading to a Decision at Commission level on whether a measure is justified or 
not  –  is  only  launched  when  another  Member  State  objects  to  a  measure  taken  against  a 
product. Where there is no disagreement on the restrictive measure taken, all Member States 
must take the appropriate action on their territory. 

3.7. 

Comitology and Delegated acts 

The provisions on the operation of standing committees have to be adapted to the new rules 
on delegated acts laid down in Article 290 of the Treaty on the Functioning of the EU and to 
the new provisions on implementing acts laid down in Regulation (EU) No 182/2011 of the 
European  Parliament  and  of  the  Council  of  16  February  2011  laying  down  the  rules  and 
general  principles  concerning  mechanisms  for  control  by  the  Member  States  of  the 
Commission's exercise of implementing powers3. 

Directive  94/9/EC  provided  for  a  standing  committee.  As  this  committee  is  not  involved  in 
the  adoption  of  implementing  acts  provided  for  in  Article  291  of  the  Treaty  on  the 
Functioning  of  the  EU,  and  no  need  to  adopt  implementing  acts  appears  under  the  new 
Directive, therefore this provision has been deleted in the proposal. 

The Commission will set up an expert working group in accordance with the Communication 
from the President to the Commission - Framework for Commission expert groups: horizontal 
rules  and  public  register  (C(2010)  7649  final),  that  will  carry  out  the  tasks  of  the  standing 
committee  provided  for  in  Directive  94/9/EC,  to  examine  any  question  relating  to  the 
application of the Directive. 

4. 

LEGAL ELEMENTS OF THE PROPOSAL 

Legal basis 

The proposal is based on Article 114 of the Treaty on the Functioning of the European Union. 

Subsidiarity principle 

The internal market is a competence that is shared between the Union and the Member States. 
The  subsidiarity  principle  arises  in  particular  with  regard  to  the  newly  added  provisions 
aiming  at  the  improvement  of  effective  enforcement  of  Directive  94/9/EC,  namely,  the 
importer  and  distributor  obligations,  the  traceability  provisions,  the  provisions  on  the 
assessment  and  notification  of  notified  bodies,  and  the  enhanced  cooperation  obligations  in 
the context of the revised market surveillance and safeguard procedures. 

Experience with the enforcement of the legislation has shown that measures taken at national 
level  have  led  to  divergent  approaches  and  to  a  different  treatment  of  economic  operators 
inside  the  EU,  which  undermines  the  objective  of  this  directive.  If  actions  are  taken  at 
national level to address the problems, this risks creating obstacles to the free movement of 
goods.  Furthermore  action  at  national  level  is  limited  to  the  territorial  competence  of  a 
Member  State.  In  view  of  the  increasing  internationalisation  of  trade,  the  number  of  cross-

3 

Regulation  (EU)  No  182/2011  of  the  European  Parliament  and  of  the  Council  of  16  February  2011 
laying down the rules and the general principles concerning mechanisms for control by Member States 
of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p.13). 

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border cases is constantly rising. Coordinated action at EU level can much better achieve the 
objectives  set,  and  will  in  particular  render  market  surveillance  more  effective.  Hence  it  is 
more appropriate to take action at EU level. 

As regards the problem of inconsistencies throughout the directives, this is a problem which 
can only be solved by the EU legislator. 

Proportionality 

In  accordance  with  the  principle  of  proportionality,  the  proposed  modifications  do  not  go 
beyond what is necessary to achieve the objectives set.  

The new or modified obligations do not impose unnecessary burdens and costs on industry - 
especially on small and medium sized enterprises - or administrations. Where modifications 
have been identified to have negative impacts, the analysis of the impacts of the option serves 
to  provide  the  most  proportionate  response  to  the  problems  identified.  A  number  of 
modifications  concern  the  improvement  of  clarity  of  the  existing  Directive  without 
introducing new requirements that entail added cost.  

Legislative technique used 

The  alignment  to  the  NLF  Decision  requires  a  number  of  substantive  amendments  to  the 
provisions of Directive 94/9/EC. To ensure the readability of the amended text the technique 
of  recasting  has  been  chosen  in  line  with  the  Interinstitutional  Agreement  of  28  November 
2001 on a more structured use of the recasting technique for legal acts4.  

The  changes  made  to  the  provisions  of  Directive  94/9/EC  concern:  the  definitions,  the 
obligations  of  economic  operators,  the  presumption  of  conformity  provided  by  harmonised 
standards,  the  declaration  of  conformity,  CE  marking,  notified  bodies,  the  safeguard  clause 
procedure and the conformity assessment procedures. 

The  proposal  does  not  change  the  scope  of  Directive  and  the  essential  health  and  safety 
requirements. 

5. 

BUDGETARY IMPLICATIONS 

This proposal does not have any implications for the EU budget. 

6. 

ADDITIONAL INFORMATION 

Repeal of existing legislation 

The adoption of the proposal will lead to repeal of Directive 94/9/EC. 

European Economic Area 

The proposal concerns the EEA and should therefore be extended to the European Economic 
Area.

4 

OJ C 77, 28. 3. 2002. 

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(cid:208) 94/9/EC (adapted) 

2011/0356 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the approximation ⌦ harmonisation ⌫ of the laws of the Member States 
concerning ⌦ relating to ⌫ equipment and protective systems intended for use in 
potentially explosive atmospheres 

(Recast) 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community ⌦ on the Functioning of 
the European Union ⌫ , and in particular Article 100a ⌦ 114 ⌫ thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments, 

Having regard to the opinion of the European Economic and Social Committee5, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(cid:216) new 

(1) 

(2) 

Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on 
the  approximation  of  the  laws  of  the  Member  States  concerning  equipment  and 
protective  systems  intended  for  use  in  potentially  explosive  atmospheres6  has  been 
substantially amended. Since further amendments are to be made, it should be recast in 
the interests of clarity. 

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 
2008 setting out the requirements for accreditation and market surveillance relating to 
the marketing of products and repealing Regulation (EEC) No 339/937 lays down rules 
on  the  accreditation  of  conformity  assessment  bodies,  provides  a  framework  for  the 

5 
6 
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OJ C […], [Date], p. […]. 
OJ L 100, 19.4.1994, p. 1. 
OJ L 218, 13.8.2008, p. 30. 

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market surveillance of products and for controls on products from third countries, and 
lays down the general principles of the CE marking. 

(3) 

Decision  No  768/2008/EC  of  the  European  Parliament  and  of  the  Council  of  9  July 
2008  on  a  common  framework  for  the  marketing of products, and repealing Council 
Decision  93/465/EEC8  lays  down  a  common  framework  of  general  principles  and 
reference  provisions  intended  to  apply  across  the  legislation  harmonising  the 
conditions  for  the  marketing  of  products  in  order  to  provide  a  coherent  basis  for 
revision or recasts of that legislation. Directive 94/9/EC should therefore be adapted to 
that Decision. 

(cid:208) 94/9/EC recital 1 (adapted) 

(4)  Whereas iIt is the duty of Member States to protect, on their territory, the safety and 
health  of  persons  and,  where  appropriate,  domestic  animals  and  property  and,  in 
particular,  that  of  workers,  especially  against  the  hazards  resulting  from  the  use  of 
equipment  and  systems  providing  protection  against  potentially  explosive 
atmospheres;. 

(cid:208) 94/9/EC recital 2 (adapted) 

Whereas mandatory provisions within the Member States determine the level of safety to be 
achieved  by  protective  equipment  and  systems  intended  for  use  in  potentially  explosive 
atmospheres;  whereas  these  are  generally  electrical  and  non-electrical  specifications  having 
an effect on the design and structure of equipment which can be used in potentially explosive 
atmospheres; 

Whereas  the  requirements  to  be  met  by  such  equipment  differ  from  one  Member  State  to 
another  in  respect  of  their  extent  and  differing  inspection  procedures;  whereas  these 
differences are, therefore, likely to raise barriers to trade within the Community; 

(cid:208) 94/9/EC recital 3 (adapted) 

Whereas  harmonization  of  national  legislation  is  the  only  way  in  which  to  remove  these 
barriers  to  free  trade;  whereas  this  objective  cannot  be  satisfactorily  achieved  by  the 
individual Member States; whereas this Directive merely lays down the requirements vital to 
freedom of movement for the equipment to which it applies; 

(cid:208) 94/9/EC recital 4 (adapted) 

Whereas the regulations intended to remove technical barriers to trade are required to follow 
the  new  approach  provided  for  in  the  Council  resolution  of  7  May  19859,  which  requires  a 
definition  of  the  essential  requirements  regarding  safety  and  other  requirements  of  society 
without  reducing  existing,  justified  levels  of  protection  within  the  Member  States;  whereas 

(cid:208) 94/9/EC recital 5 (adapted) 

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9 

OJ L 218, 13.8.2008, p. 82. 
OJ No C 136, 4. 6. 1985, p. 1. 

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that resolution provides that a very large number of products be covered by a single Directive 
in order to avoid frequent amendments and the proliferation of Directives; 

(cid:208) 94/9/EC recitals 6 and 8 
(adapted) 

(5)  Whereas the existing Directives ⌦ 94/9/EC ⌫ on the approximation of the laws of 
the Member States to electrical equipment for use in potentially explosive atmospheres 
have  ⌦ has ⌫  made  positive  steps  towards  ⌦ effective ⌫  protection  against 
explosions via measures linked with the structure of the equipment at issue and which 
have helped to remove barriers to trade in this area; whereas, in parallel, a revision and 
expansion of the existing Directives is necessary since, more particularly, in an overall 
context, action must be taken to guard against the potential hazards arising from such 
equipment.  This  implies  in  particular  that  measures  intended  to  guarantee  effective 
protection  of  users  and  third  parties  must  already  be  contemplated  at  the  design  and 
manufacturing  states; ⌦ hazards  for  both  mining  and  surface  equipment.  Those ⌫ 
Whereas the two groups of equipment referred to above are used in a large number of 
commercial and industrial sectors and possess considerable economic significance. 

Whereas the form taken by the hazard, the protective measures and the test methods are often 
very similar, if not identical, for both mining and surface equipment; whereas it is, therefore, 
absolutely necessary to cover by a single Directive protective equipment and systems falling 
within both groups; 

(cid:208) 94/9/EC recital 7 (adapted) 

(cid:208) 94/9/EC recital 9 (adapted) 

(6)  Whereas cCompliance with the basic safety and health ⌦ and safety ⌫ requirements 
is essential in order to ensure the safety of protective equipment and systems.; whereas 
tThose  requirements  have  been  ⌦ should  be ⌫  subdivided  into  general  and 
additional  requirements  which  must  ⌦ need  to ⌫  be  met  by  protective  equipment 
and  systems.;  whereas,  In  particular,  the  additional  requirements  are  intended  to 
⌦ should ⌫  take  account  of  existing  or  potential  hazards.;  whereas  Protective 
equipment  and  systems  will ⌦ should ⌫  ,  therefore,  embody  at  least  one  of  those 
requirements where this is necessary for their proper functioning or is to apply to their 
intended  use.;  whereas  The  notion  of  intended  use  is  of  prime  importance  for  the 
explosion-proofing of protective equipment and  systems.; whereas It is essential that 
manufacturers  supply  full  information.;  whereas  Specific,  clear  marking  of  said 
⌦ that ⌫  equipment,  stating  its  use  in  a  potentially  explosive  atmosphere,  is  also 
necessary. 

Whereas  the  intention  is  to  prepare  a  Directive  on  operations  in  potentially  explosive 
atmospheres  which  is  based  on  Article  118a;  whereas  that  additional  Directive  will,  in 
particular, aim at explosion hazards which derive from a given use and/or types and methods 
of installation; 

(cid:208) 94/9/EC recital 10 (adapted) 

EN 

11 

   EN 

 
 
 
 
(cid:208) 94/9/EC recital 11 (adapted) 

(7)  Whereas  cCompliance  with  ⌦ the ⌫  essential  health  and  safety  requirements  is 
imperative  if  ⌦ in  order  to  ensure ⌫  the  safety  of  equipment  is  to  be  ensured.; 
whereas judgment will have to be exercised in ⌦ For ⌫ the implementation of those 
requirements  ⌦ ,  both  the  technology  obtained  at  the  time  of  manufacture  and 
overriding  technical  and  economic  requirements ⌫  in  order  to  take  ⌦ should  be 
taken into ⌫ account of both the technology obtaining at the time of manufacture and 
overriding technical and economic requirements. 

(cid:208) 94/9/EC recital 12 (adapted) 

Whereas,  therefore,  this  Directive  sets  out  essential  requirements  only;  whereas,  in  order  to 
facilitate  the  task  of  proving  compliance  with  the  essential  requirements,  harmonized 
European standards are necessary, more especially with regard to the non-electrical aspects of 
protection against explosions — standards relating to the design, manufacture and testing of 
equipment, compliance with which enables a product to be presumed to meet such essential 
requirements;  whereas  harmonized  European  standards  are  drawn  up  by  private  bodies  and 
must  retain  their  non-mandatory  status;  whereas,  for  this  purpose,  the  European  Committee 
for Standardization (CEN) and the European Committee for Electrotechnical Standardization 
(Cenelec)  are  recognized  as  the  bodies  competent  to  adopt  harmonized  standards  which 
follow the general guidelines for cooperation between the Commission and those two bodies, 
signed  on  13  November  1984;  whereas,  for  the  purposes  of  this  Directive,  a  harmonized 
standard is a technical specification (European Standard or harmonization document) adopted 
by one or other of those bodies, or by both, at the prompting of the Commission pursuant to 
Council Directive 83/189/EEC of the 28 March 1983 providing for a procedure governing the 
provision of information on technical standards and regulations10 and pursuant to the general 
guidelines referred to above; 

Whereas the legislative framework should be improved in order to ensure that employers and 
workers make an effective and appropriate contribution towards the standardization process; 
whereas this should be completed by the time this Directive is implemented; 

(cid:208) 94/9/EC recital 13 (adapted) 

(cid:208) 94/9/EC recital 14 (adapted) 

Whereas,  in  view  of  the  nature  of  the  risks  involved  in  the  use  of  equipment  in  potentially 
explosive  atmospheres  it  is  necessary  to  establish  procedures  applying  to  the  assessment  of 
compliance with the basic requirements of the Directives; whereas these procedures must be 
devised  in  the  light  of  the  level  of  risk  which  may  be  inherent  in  equipment  and/or  against 
which systems must protect the immediate environment; whereas, therefore, each category of 
equipment conformity must be supplemented by an adequate procedure or a choice between 
several  equivalent  procedures;  whereas  the  procedures  adopted  comply  fully  with  Council 
Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the 

10 

OJ No L 109, 26. 4. 1983, p. 8. Directive as last amended by Directive 88/182/EEC (OJ No L 81, 26. 3. 
1988, p. 75). 

EN 

12 

   EN 

 
 
 
 
                                                 
conformity  assessment  procedures  which  are  intended  to  be  used  in  the  technical 
harmonization Directives11; 

Whereas  the  Council  has  provided  for  the  affixing  of  the  CE  marking  by  either  the 
manufacturer  or  his  authorized  representative  within  the  Community;  whereas  that  marking 
means  that  the  product  complies  with  all  the  basic  requirements  and  assessment  procedures 
provided for by the Community law applying to that product; 

(cid:208) 94/9/EC recital 15 (adapted) 

(cid:208) 94/9/EC recital 16 (adapted) 

Whereas  it  is  appropriate  that  the  Member  States,  as  provided  for  by  Article  100a  of  the 
Treaty, may  take  temporary measures to limit or prohibit the placing on the market and the 
use of equipment and protective systems in cases where they present a particular risk to the 
safety  of  persons  and,  where  appropriate,  domestic  animals  or  property,  provided  that  the 
measures are subject to a Community control procedure; 

Whereas  the  recipients  of  any  decision  taken  as  part  of  this  Directive  must  be  aware  of  the 
reasons behind that decision and the means of appeal open to them; 

(cid:208) 94/9/EC recital 17 (adapted) 

(cid:208) 94/9/EC recital 18 (adapted) 

Whereas,  on  18  December  1985,  the  Council  adopted  a  framework  Directive  on  electrical 
equipment for use in potentially explosive atmospheres (76/117/EEC)12 and, on 15 February 
1982,  a  Directive  concerning  electrical  equipment  for  use  in  potentially  explosive 
atmospheres  in  mines  susceptible  to  fire  damp  (82/130/EEC)13;  whereas,  from  the  outset  of 
harmonization  work,  the  conversion  into  total  harmonization  of  the  optional  and  partial 
harmonization  on  which  these  Directives  are  based  had  been  contemplated;  whereas  this 
Directive  fully  covers  the  scope  of  the  abovementioned  Directives  and  whereas,  therefore, 
these Directives must be repealed; 

Whereas the internal market incorporates an area without internal frontiers within which the 
free movement of goods, persons, services and capital is assured; 

(cid:208) 94/9/EC recital 19 (adapted) 

Whereas  it  is  necessary  to  provide  for  a  transitional  arrangement  enabling  equipment 
manufactured in compliance with the national regulations in force at the date of adoption of 
this Directive to be marketed and placed in service; 

(cid:208) 94/9/EC recital 20 (adapted) 

11 
12 

13 

OJ No L 220, 30. 8. 1993, p. 23. 
OJ No L 24, 31. 1. 1976, p. 45. Directive as last amended by Directive 90/487/EEC (OJ No L 270, 2. 
10. 1990, p. 23). 
OJ No L 59, 2. 3. 1982, p. 10. 

EN 

13 

   EN 

 
 
 
 
 
 
                                                 
(cid:216) new 

(8) 

(9) 

Economic operators should be responsible for the compliance of products, in relation 
to their respective roles in the supply chain, so as to ensure a high level of protection 
of public interests, such as health and safety, and the protection of end-users and of the 
environment, and to guarantee fair competition on the Union market. 

All  economic  operators  intervening  in  the  supply  and  distribution  chain  should  take 
appropriate measures to ensure that they make available on the market only products 
which are in conformity with this Directive. It is necessary to provide for a clear and 
proportionate distribution of obligations which correspond to the role of each operator 
in the supply and distribution process. 

(10)  The manufacturer, having detailed knowledge of the design and production process, is 
best  placed  to  carry  out  the  complete  conformity  assessment  procedure.  Conformity 
assessment should therefore remain the obligation of the manufacturer alone. 

(11) 

It is necessary to ensure that products from third countries entering the Union market 
comply  with  the  requirements  of  this  Directive,  and  in  particular  that  appropriate 
assessment  procedures  have  been  carried  out  by  manufacturers  with  regard  to  those 
products.  Provision  should  therefore  be  made  for  importers  to  make  sure  that  the 
products they place on the market comply with the requirements of this Directive and 
that  they  do  not  place  on  the  market  products  which  do  not  comply  with  such 
requirements  or  present a  risk. Provision should also be made for  importers  to make 
sure  that  conformity  assessment  procedures  have  been  carried  out  and  that  product 
marking and documentation drawn up by manufacturers are available for inspection by 
the supervisory authorities. 

(12)  The distributor makes a product available on the market after it has been placed on the 
market by the manufacturer or the importer and should act with due care to ensure that 
its handling of the product does not adversely affect the compliance of the product. 

(13)  When placing a product on the market, every importer should indicate on the product 
his name and the address at which he can be contacted. Exceptions should be provided 
for  in  cases  where  the  size  or  nature  of  the  product  does  not  allow  it.  This  includes 
cases  where  the  importer  would  have  to  open  the  packaging  to  put  his  name  and 
address on the product. 

(14)  Any economic operator that either places a product on the market under his own name 
or  trademark  or  modifies  a  product  in  such  a  way  that  compliance  with  the 
requirements  of  this  Directive  may  be  affected  should  be  considered  to  be  the 
manufacturer and should assume the obligations of the manufacturer. 

(15)  Distributors  and  importers,  being  close  to  the  market  place,  should  be  involved  in 
market surveillance tasks carried out by the competent national authorities, and should 
be  prepared  to  participate  actively,  providing  those  with  all  necessary  information 
relating to the product concerned. 

(16)  Ensuring  traceability  of  a  product  throughout  the  whole  supply  chain  helps  to  make 
market  surveillance  simpler  and  more  efficient.  An  efficient  traceability  system 

EN 

14 

   EN 

 
facilitates  market  surveillance  authorities'  task  of  tracing  economic  operators  who 
made non-compliant products available on the market. 

(17)  This  Directive  should  be  limited  to  the  expression  of  the  essential  health  and  safety 
requirements. In order to facilitate conformity assessment with those requirements it is 
necessary  to  provide  for  presumption  of  conformity  for  products  which  are  in 
conformity with harmonised standards that are adopted in accordance with Regulation 
(EU)  No  [../..]  of  the  European  Parliament  and  of  the  Council  of  […..]  on  European 
Standardisation  and  amending  Council  Directives  89/686/EEC  and  93/15/EEC  and 
Directives  94/9/EC,  94/25/EC,  95/16/EC,  97/23/EC,  98/34/EC,  2004/22/EC, 
2007/23/EC,  2009/105/EC  and  2009/23/EC  of  the  European  Parliament  and  of  the 
Council14  for  the  purpose  of  expressing  detailed  technical  specifications  of  those 
requirements. 

(18)  Regulation (EU) No [../..] [on European Standardisation] provides for a procedure for 
objections  to  harmonised  standards  where  those  standards  do  not  entirely  satisfy 
requirements of this Directive. 

(19) 

In order to enable economic operators to demonstrate and the competent authorities to 
ensure that products made available on the market conform to the essential health and 
safety  requirements  it  is  necessary  to  provide  for  conformity  assessment  procedures. 
Decision No 768/2008/EC establishes modules for conformity assessment procedures, 
which  include  procedures  from  the  least  to  the  most  stringent,  in  proportion  to  the 
level of risk involved and the level of safety required. In order to ensure inter-sectoral 
coherence and to avoid ad-hoc variants, conformity assessment procedures should be 
chosen from among those modules. 

(20)  The manufacturer should draw up an EU declaration of conformity to provide detailed 

information on the conformity of a product with the requirements of this Directive. 

(21)  The CE marking, indicating the conformity of a product, is the visible consequence of 
a  whole  process  comprising  conformity  assessment  in  a  broad  sense.  General 
principles  governing  the  CE  marking  are  set  out  in  Regulation  (EC)  No  765/2008. 
Rules governing the affixing of the CE marking should be laid down in this Directive. 

(22)  The conformity assessment procedures set out in this Directive require the intervention 
of  conformity  assessment  bodies,  which  are  notified  by  the  Member  States  to  the 
Commission. 

(23)  Experience  has  shown  that  the  criteria  set  out  in  Directive  94/9/EC  that  conformity 
assessment bodies have to fulfil to be notified to the Commission are not sufficient to 
ensure a uniformly high level of performance of notified bodies throughout the Union. 
It  is,  however,  essential  that  all  notified  bodies  perform  their  functions  to  the  same 
level and under conditions of fair competition. That requires the setting of obligatory 
requirements  for  conformity  assessment  bodies  wishing  to  be  notified  in  order  to 
provide conformity assessment services. 

14 

OJ L […], [Date], p. […]. 

EN 

15 

   EN 

                                                 
(24) 

(25) 

In  order  to  ensure  a  consistent  level  of  quality  in  the  performance  of  conformity 
assessment it is also necessary to set requirements for notifying authorities and other 
bodies involved in the assessment, notification and monitoring of notified bodies. 

If a conformity assessment body demonstrates conformity with the criteria laid down 
in  harmonised  standards,  it  should  be  presumed  to  comply  with  the  corresponding 
requirements set out in this Directive. 

(26)  The  system  set  out  in  this  Directive  should  be  complemented  by  the  accreditation 
system  provided  for  in  Regulation  (EC)  No  765/2008.  Since  accreditation  is  an 
essential  means  of  verifying  the  competence  of  conformity  assessment  bodies,  it 
should also be used for the purposes of notification. 

(27)  Transparent  accreditation  as  provided  for  in  Regulation  (EC)  No  765/2008,  ensuring 
the necessary level of confidence in conformity certificates, should be considered by 
the  national  public  authorities  throughout  the  Union  as  the  preferred  means  of 
demonstrating  the  technical  competence  of  conformity  assessment  bodies.  However, 
national authorities may consider that they possess the appropriate means of carrying 
out this evaluation themselves. In such cases, in order to ensure the appropriate level 
of  credibility  of  evaluations  carried  out  by  other  national  authorities,  they  should 
provide the Commission and the other Member States with the necessary documentary 
evidence demonstrating the compliance of the conformity assessment bodies evaluated 
with the relevant regulatory requirements. 

(28)  Conformity assessment bodies frequently subcontract parts of their activities linked to 
the  assessment  of  conformity  or  have  recourse  to  a  subsidiary.  In  order  to  safeguard 
the level of protection required for the products to be placed on the Union market, it is 
essential  that  conformity  assessment  subcontractors  and  subsidiaries  fulfil  the  same 
requirements  as  notified  bodies  in  relation  to  the  performance  of  conformity 
assessment tasks. Therefore, it is important that the assessment of the competence and 
the performance of bodies to be notified and the monitoring of bodies already notified 
cover also activities carried out by subcontractors and subsidiaries. 

(29) 

It is necessary to increase the efficiency and transparency of the notification procedure 
and, in particular, to adapt it to new technologies so as to enable online notification. 

(30)  Since notified bodies may offer their services throughout the Union, it is appropriate to 
give the other Member States and the Commission the opportunity to raise objections 
concerning  a  notified  body.  It  is  therefore  important  to  provide  for  a  period  during 
which any doubts or concerns as to the competence of conformity assessment bodies 
can be clarified before they start operating as notified bodies. 

(31) 

In  the  interests  of  competitiveness,  it  is  crucial  that  notified  bodies  apply  the 
conformity assessment procedures without creating unnecessary burdens for economic 
operators. For the same reason, and to ensure equal treatment of economic operators, 
consistency in the technical application of the conformity assessment procedures must 
be  ensured.  That  can  best  be  achieved  through  appropriate  coordination  and 
cooperation between notified bodies. 

(32) 

In order to ensure legal certainty, it is necessary to clarify that rules on Union market 
surveillance  and  control  of  products  entering  the  Union  market  provided  for  in 
Regulation  (EC)  No  765/2008  apply  to  products  covered  by  this  Directive.  This 

EN 

16 

   EN 

Directive should not prevent Member States from choosing the competent authorities 
to carry out those tasks. 

(33)  Directive  94/9/EC  already  provides  for  a  safeguard  procedure.  In  order  to  increase 
transparency  and  to  reduce  processing  time,  it  is  necessary  to  improve  the  existing 
safeguard  clause  procedure,  with  a  view  to  making  it  more  efficient  and  drawing  on 
the expertise available in Member States. 

(34)  The  existing  system  should  be  supplemented  by  a  procedure  under  which  interested 
parties  are  informed  of  measures  intended  to  be  taken  with  regard  to  products 
presenting  a  risk  to  the  health  and  safety  of  persons  or  to  other  aspects  of  public 
interest protection. It should also allow market surveillance authorities, in cooperation 
with  the  relevant  economic  operators,  to  act  at  an  earlier  stage  in  respect  of  such 
products. 

(35)  Where  the  Member  States  and  the  Commission  agree  as  to  the  justification  of  a 
measure taken by a Member State, no further involvement of the Commission should 
be  required,  except  where  non-compliance  can  be  attributed  to  shortcomings  of  a 
harmonised standard. 

(36)  The Member States should lay down rules on penalties applicable to infringements of 
the  national  provisions  adopted  pursuant  to  this  Directive  and  ensure  that  they  are 
implemented. Those penalties should be effective, proportionate and dissuasive. 

(37) 

It is necessary to provide for transitional arrangements that allow making available on 
the market and putting into service of products that have already been placed on the 
market in accordance with Directive 94/9/EC. 

(38)  Since  the  objective  of  this  Directive,  namely  to  ensure  that  products  on  the  market 
fulfil  the  requirements  providing  a  high  level  of  protection  of  health  and  safety  and 
other public interests while guaranteeing the functioning of the internal market, cannot 
be sufficiently achieved by the Member States and can therefore, by reason of its scale 
and  effects,  be  better  achieved  at  Union  level,  the  Union  may  adopt  measures,  in 
accordance  with  the  principle  of  subsidiarity  as  set  out  in  Article  5  of  the  Treaty  on 
European Union. In accordance with the principle of proportionality, as set out in that 
Article, this Directive does  not go beyond what is necessary in order to achieve that 
objective. 

(39)  The obligation to transpose this Directive into national law should be confined to those 
provisions which represent a substantive change as compared with Directive 94/9/EC. 
The obligation to transpose the provisions which are unchanged arises under Directive 
94/9/EC. 

(40)  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 
Directive 94/9/EC set out in Annex X, Part B, 

EN 

17 

   EN 

HAVE ADOPTED THIS DIRECTIVE: 

CHAPTER I1 

(cid:208) 94/9/EC 

SCOPE, PLACING ON THE MARKET AND FREEDOM OF MOVEMENT ⌦ GENERAL 
PROVISIONS ⌫ 

(cid:208) 94/9/EC (adapted) 

Article 1 

⌦ Scope ⌫ 

1. This Directive applies ⌦ shall apply ⌫ to ⌦ the following products: ⌫ 

(a) equipment and protective systems intended for use in potentially explosive atmospheres.; 

(cid:208) 94/9/EC 

(cid:208) 94/9/EC (adapted) 

(b)  2.  Ssafety  devices,  controlling  devices  and  regulating  devices  intended  for  use  outside 
potentially explosive atmospheres but required for or contributing to the safe functioning of 
equipment and protective systems with respect to the risks of explosion are also covered by 
the scope of this Directive. 

4.2. ⌦ This Directive shall not apply to ⌫ Tthe following are excluded from the scope of 
this Directive ⌦ products ⌫ : 

medical devices intended for use in a medical environment; 

(cid:208) 94/9/EC 

equipment  and  protective  systems  where  the  explosion  hazard  results  exclusively 
from the presence of explosive substances or unstable chemical substances; 

equipment  intended  for  use  in  domestic  and  non-commercial  environments  where 
potentially explosive atmospheres may only rarely be created, solely as a result of the 
accidental leakage of fuel gas; 

personal protective equipment covered by Council Directive 89/686/EEC15; 

OJ L 399, 30.12. 1989, p. 18. 

– 

– 

– 

– 

15 

EN 

18 

   EN 

 
 
 
 
 
                                                 
– 

– 

seagoing  vessels  and  mobile  offshore  units  together  with  equipment  on  board  such 
vessels or units; 

means  of  transport,  i.e.  vehicles  and  their  trailers  intended  solely  for  transporting 
passengers by air or by road, rail or water networks, as well as means of transport in 
so far as such means are designed for transporting goods by air, by public road or rail 
networks  or  by  water.  Vehicles  intended  for  use  in  a  potentially  explosive 
atmosphere shall not be excluded; 

– 

the equipment covered by Article 223346(1)(b) of the Treaty. 

(cid:208) 94/9/EC (adapted) 

Article 2 

⌦ Definitions ⌫ 

3.For the purposes of this Directive, the following definitions shall apply: 

Equipment and protective systems intended for use in potentially explosive atmospheres 

(cid:208) 94/9/EC 
(cid:206)1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 

(1) (a) 'Eequipment' means machines, apparatus, fixed or mobile devices, control components 
and instrumentation thereof and detection or prevention systems which, separately or jointly, 
are intended for the generation, transfer, storage, measurement, (cid:206)1 control and conversion of 
energy  and/or  the  processing   of  material  and  which  are  capable  of  causing  an  explosion 
through their own potential sources of ignition.; 

(cid:208) 94/9/EC 
(cid:206)1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 
(cid:214) new 

(2)  (b)  (cid:206)1 'Pprotective  systems'  means  devices  other  than  components  of  the  equipment 
defined above which are intended to halt incipient explosions immediately and/or to limit the 
effective range of an explosion and which are separately placed (cid:214) made available  on the 
market for use as autonomous systems.  ; 

(3)  (c)'Ccomponents'  means  any  item  essential  to  the  safe  functioning  of  equipment  and 
protective systems but with no autonomous function.; 

(cid:208) 94/9/EC (adapted) 

Explosive atmospheres 

EN 

19 

   EN 

 
 
 
 
(4) ⌦ 'explosive atmosphere' means a ⌫ Mmixture with air, under atmospheric conditions, 
of flammable substances in the form of gases, vapours, mists or dusts in which, after ignition 
has occurred, combustion spreads to the entire unburned mixture.; 

Potentially explosive atmosphere 

(5)  ⌦ 'potentially  explosive  atmosphere'  means ⌫  Aan  atmosphere  which  could  become 
explosive due to local and operational conditions.; 

Equipment groups and categories 

(cid:208) 94/9/EC (adapted) 
(cid:206)1 Corrigendum, OJ L 304, 
5.12.2000, p. 19 

'Eequipment  group  I'  applies  ⌦ means ⌫  equipment  intended  for  use  (cid:206)1 in 
(6) 
underground parts of mines, and in those parts of  surface installations of such mines, liable 
to  be  endangered  by  firedamp  and/or  combustible  dust. ⌦ ,  comprising  categories  M1  and 
M2 as set out in Annex I; ⌫ 

(cid:208) 94/9/EC (adapted) 

(7)  'Eequipment  group  II'  applies ⌦ means ⌫  equipment  intended  for  use  in  other  places 
liable to be endangered by explosive atmospheres. ⌦ , comprising categories 1, 2 and 3 as 
set out in Annex I; ⌫ 

(8)  ⌦ 'category  of  equipment' means  the  definition  of  the  required  levels  of  protection,  as 
referred  to  ⌫  The  categories  of  equipment  defining  the  required  levels  of  protection  are 
described in Annex I.; 

Equipment and protective systems may be designed for a particular explosive atmosphere. In 
this case, they must be marked accordingly. 

Intended use 

(9)  ⌦ 'intended  use'  means ⌫  Tthe  use  of  equipment,  protective  systems,  and  devices 
referred  to  in  Article  1  (2)  ⌦ products ⌫  in  accordance  with  the  equipment  group  and 
category and with all the information supplied by the manufacturer which is required for the 
safe functioning of equipment, protective systems and devices. ⌦ products; ⌫ 

(cid:216) new 

[Article R1 of Decision No 768/2008/EC] 

(10)  'making  available  on  the  market'  means  any  supply  of  a  product  for  distribution, 
consumption or use on the Union market in the course of a commercial activity, whether in 
return for payment or free of charge; 

(11)  'placing  on  the  market'  means  the  first  making  available  of  a  product  on  the  Union 
market; 

EN 

20 

   EN 

 
 
 
(12)  'manufacturer'  means  any  natural  or  legal  person  who  manufactures  a  product  or  has  a 
product designed or manufactured, and markets that product under his name or trademark; 

(13) 'authorised representative' means any natural or legal person established within the Union 
who  has  received  a  written  mandate  from  a  manufacturer  to  act  on  his  behalf  in  relation  to 
specified tasks; 

(14) 'importer' means any natural or legal person established within the Union who places a 
product from a third country on the Union market; 

(15)  'distributor'  means  any  natural  or  legal  person  in  the  supply  chain,  other  than  the 
manufacturer or the importer, who makes a product available on the market; 

(16) 'economic operators' means the manufacturer, the authorised representative, the importer 
and the distributor; 

(17)  'technical  specification'  means  a  document  that  prescribes  technical  requirements  to  be 
fulfilled by a product, process or service; 

(18)  'harmonised  standard'  means  harmonised  standard  as  defined  in  Article  2(1)(c)  of 
Regulation (EU) No [../..] [on European Standardisation]; 

(19)  'accreditation'  means  accreditation  as  defined  in  Article  2(10)  of  Regulation  (EC)  No 
765/2008; 

(20)  'national  accreditation  body'  means  accreditation  body  as  defined  in  Article  2(11)  of 
Regulation (EC) No 765/2008; 

(21)  'conformity  assessment'  means  the  process  demonstrating  whether  the  essential  health 
and safety requirements relating to a product, process, service or system have been fulfilled; 

(22)  'conformity  assessment  body'  means  a  body  that  performs  conformity  assessment 
activities including calibration, testing, certification and inspection; 

(23)  'recall'  means  any  measure  aimed  at  achieving  the  return  of  a  product  that  has  already 
been made available to the end user; 

(24) 'withdrawal' means any measure aimed at preventing a product in the supply chain from 
being made available on the market; 

(25) 'CE marking' means a marking by which the manufacturer indicates that the product is in 
conformity  with  the  applicable  requirements  set  out  in  Union  harmonisation  legislation 
providing for its affixing; 

(26)  'Union  harmonisation  legislation'  means  any  Union  legislation  harmonising  the 
conditions for the marketing of products. 

EN 

21 

   EN 

(cid:208) 94/9/EC (adapted) 
(cid:214) new 

Article 23 

⌦ Making available on the market ⌫ 

1. Member States shall take all appropriate measures to ensure that the equipment, protective 
systems  and  devices  referred  to  in  Article  1  (2)  to  which  this  Directive  applies 
⌦ products ⌫ may be placed (cid:214) made available  on the market and put into service only 
if,  when  properly  installed  and  maintained  and  used  for  ⌦ in  accordance  with ⌫  their 
intended  purpose,  they  do  not  endanger  the  health  and  safety  of  persons  and,  where 
appropriate, domestic animals or property ⌦ comply with this Directive ⌫ .  

2. The provisions of tThis Directive shall not affect Member States' entitlement to lay down, 
in  due  observance  of  the  provisions  of  the  Treaty,  such  requirements  as  they  may  deem 
necessary  to  ensure  that  persons  and,  in  particular,  workers  are  protected  when  using  the 
equipment, protective systems, and devices referred to in Article 1 (2) in question ⌦ relevant 
products ⌫  provided  that  this  does  not  mean  that  such  equipment,  protective  systems,  or 
devices ⌦ products ⌫ are modified in a way not specified in the ⌦ this ⌫ Directive. 

3.  At  trade  fairs,  exhibitions,  ⌦ and ⌫  demonstrations,  etc.,  Member  States  shall  not 
prevent the showing of equipment, protective systems, or the devices referred to in Article 1 
(2)  ⌦ products ⌫  which  do  not  conform  to  the  provisions  of  ⌦ comply  with ⌫  this 
Directive,  provided  that  a  visible  sign  clearly  indicates  that  such  equipment,  protective 
systems,  and  devices  referred  to  in  Article  1  (2)  ⌦ products ⌫  do  not  conform 
⌦ comply ⌫ and that they are not for sale until they have been brought into conformity by 
the manufacturer or his authorized representative established in the Community ⌦ Union ⌫ 
. During demonstrations, adequate safety measures shall be taken to ensure the protection of 
persons. 

(cid:208) 94/9/EC (adapted) 

Article 34 

⌦ Essential health and safety requirements ⌫ 

Equipment,  protective  systems,  and  the  devices  referred  to  in  Article  1  (2)  to  which  this 
Directive applies must ⌦ Products shall ⌫ meet the essential health and safety requirements 
set out in Annex II which apply to them, account being taken of their intended use. 

EN 

22 

   EN 

 
 
(cid:208) 94/9/EC (adapted) 
(cid:206)1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 
(cid:214) new 

Article 45 

⌦ Free movement ⌫ 

1. Member States shall not prohibit, restrict or impede the placing (cid:214) making available  on 
the  market  and  putting  into  service  in  their  territory  of  equipment,  protective  systems,  or 
devices referred to in Article 1 (2) ⌦ products ⌫ which comply with this Directive. 

2. Member States shall not prohibit, restrict or impede the placing (cid:214) making available  on 
the market of components which, (cid:206)1 accompanied by a written attestation of conformity as 
referred  to  in  Article  8(3)   13(3),  are  intended  to  be  incorporated  into  equipment  or 
protective systems ⌦ products ⌫ within the meaning of this Directive. 

(cid:208) 94/9/EC 

Article 5 

1. Member States shall regard as conforming to all the provisions of this Directive, including 
the relevant conformity assessment procedures laid down in chapter II: 

– 

– 

equipment, protective systems, and devices referred to in Article 1 (2) accompanied 
by  the  EC  declaration  of  conformity  referred  to  in  Annex  X  and  bearing  the  CE 
marking provided for in Article 10, 

the  components  referred  to  in  Article  4  (2),  accompanied  by  the  certificate  of 
conformity referred to in Article 8 (3). 

In the absence of harmonized standards, Member States shall take any steps which they deem 
necessary  to  bring  to  the  attention  of  the  parties  concerned  the  existing  national  technical 
standards and specifications regarded as important or relevant to the proper implementation of 
the essential health and safety requirements in Annex II. 

2. Where a national standard transposing a harmonized standard, the reference for which has 
been published in the Official Journal of the European Communities, covers one or more of 
the essential health and safety requirements, the equipment, protective system, device referred 
to  in  Article  1  (2),  or  the  component  referred  to  in  Article  4  (2),  constructed  in  accordance 
with that standard shall be presumed to comply with the relevant essential health and safety 
requirements. 

Member  States  shall  publish  the  references  of  national  standards  transposing  harmonized 
standards. 

EN 

23 

   EN 

 
 
3.  Member  States  shall  ensure  that  appropriate  measures  are  taken  to  enable  the  social 
partners  to  influence  the  process  of  preparing  and  monitoring  the  harmonized  standards  at 
national level. 

Article 6 

1. Where a Member State or the Commission considers that the harmonized standards referred 
to in Article 5 (2) do not entirely satisfy the relevant essential health and safety requirements 
referred to in Article 3, the Commission or the Member State concerned shall bring the matter 
before  the  Committee  set  up  under  Directive  83/189/EEC,  hereinafter  referred  to  as  «the 
Committee'», giving reasons therefor. The Committee shall deliver an opinion without delay. 

Upon  receipt  of  the  Committee's  opinion,  the  Commission  shall  inform  the  Member  States 
whether  or  not  it  is  necessary  to  withdraw  those  standards  from  the  published  information 
referred to in Article 5 (2). 

2. The Commission may adopt any appropriate measure with a view to ensuring the practical 
application in a uniform manner of this Directive in accordance with the procedure laid down 
in paragraph 3. 

(cid:208) Regulation (EC) No 1882/2003 

3. The Commission shall be assisted by a standing committee (hereinafter referred to as 'the 
Committee'. 

Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/486/EC16 shall 
apply, having regard to the provisions of Article 8 thereof. 

The Committee shall adopt its rules of procedure. 

4. The Standing Committee may furthermore examine any question relating to the application 
of this Directive and raised by its chairman either on the latter's initiative, or at the request of 
a Member State. 

(cid:208) 94/9/EC 

Article 7 

(cid:208) 94/9/EC 

1. When a Member State ascertains that equipment, protective systems or devices referred to 
in  Article  1  (2)  bearing  the  CE  conformity  marking  and  used  in  accordance  with  their 
intended  use  are  liable  to  endanger  the  safety  of  persons  and,  where  appropriate,  domestic 
animals  or  property,  it  shall  take  all  appropriate  measures  to  withdraw  such  equipment  or 
protective systems from the market, to prohibit the placing on the market, putting into service 
or use thereof, or to restrict free movement thereof. 

16 

Council  Decision  1999/468/EC  of  28  June  1999  laying  down  the  procedures  for  the  exercise  of 
implementing powers conferred to the Commission (OJ L 184, 17.7.1999, p. 23). 

EN 

24 

   EN 

 
 
 
                                                 
The Member State shall immediately inform the Commission of any such measure, indicating 
the reasons for its decision and, in particular, whether non-conformity is due to: 

(a) 

(b) 

(c) 

failure to satisfy the essential requirements referred to in Article 3; 

incorrect application of the standards referred to in Article 5 (2); 

shortcomings in the standards referred to in Article 5 (2). 

2.  The  Commission  shall  enter  into  consultation  with  the  parties  concerned  without  delay. 
Where the Commission considers, after this consultation, that the measure is justified, it shall 
immediately  so  inform  the  Member  State  which  took  the  initiative  and  the  other  Member 
States. Where the Commission considers, after this consultation, that the action is unjustified, 
it  shall  immediately  so  inform  the  Member  State  which  took  the  initiative  and  the 
manufacturer or  his authorized representative established within the Community. Where the 
decision referred to in paragraph 1 is based on a shortcoming in the standards and where the 
Member  State  at  the  origin  of  the  decision  maintains  its  position,  the  Commission  shall 
immediately inform the Committee in order to initiate the procedures referred to in Article 6 
(1). 

3. Where equipment, a protective system or a device referred to in Article 1(2) which does not 
comply bears the CE conformity marking, the competent Member State shall take appropriate 
action against the person(s) having affixed the marking and shall so inform the Commission 
and the other Member States. 

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

(cid:216) new 

CHAPTER 2 

OBLIGATIONS OF ECONOMIC OPERATORS 

Article 6 [Article R2 of Decision No 768/2008/EC] 

Obligations of manufacturers 

1. When placing their products on the market, manufacturers shall ensure that they have been 
designed  and  manufactured  in  accordance  with  the  essential  health  and  safety  requirements 
set out in Annex II. 

2. Manufacturers shall draw up the technical documentation referred to in Annex II and carry 
out the relevant conformity assessment procedure referred to in Article 13 or have it carried 
out. 

EN 

25 

   EN 

 
Where  compliance  of  a  product  with  the  applicable  requirements  has  been  demonstrated  by 
that procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE 
marking and the specific marking of explosion protection. 

3.  Manufacturers  shall  keep  the  technical  documentation  and  the  EU  declaration  of 
conformity for at least 10 years after the product has been placed on the market. 

4. Manufacturers shall ensure that procedures are in place for series production to remain in 
conformity.  Changes  in  a  product  design  or  characteristics  and  changes  in  the  harmonised 
standards  or  in  technical  specifications  by  reference  to  which  conformity  of  a  product  is 
declared shall be adequately taken into account. 

5. Manufacturers shall ensure that their products bear a type, batch or serial number or other 
element  allowing  their  identification,  or,  where  the  size  or  nature  of  the  product  does  not 
allow  it,  that  the  required  information  is  provided  on  the  packaging  or  in  a  document 
accompanying the product. 

6. Manufacturers shall indicate their name and the address at which they can be contacted on 
the product or, where that is not possible, on its packaging or in a document accompanying 
the  product.  The  address  must  indicate  a  single  point  at  which  the  manufacturer  can  be 
contacted. 

7.  Manufacturers  shall  ensure  that  the  product  is  accompanied  by  instructions  and  safety 
information in a language which can be easily understood by end-users, as determined by the 
Member State concerned. 

8.  Manufacturers  who  consider  or  have  reason  to  believe  that  a  product  which  they  have 
placed  on  the  market  is  not  in  conformity  with  this  Directive  shall  immediately  take  the 
necessary corrective measures to bring that product into conformity, to withdraw it or recall it, 
if  appropriate.  Furthermore,  where  the  product  presents  a  risk,  manufacturers  shall 
immediately  inform  the  competent  national  authorities  of  the  Member  States  in  which  they 
made the product available to that effect, giving details, in particular, of the non-compliance 
and of any corrective measures taken. 

9.  Manufacturers  shall,  further  to  a  reasoned  request  from  a  competent  national  authority, 
provide  it  with  all  the  information  and  documentation  necessary  to  demonstrate  the 
conformity  of  the  product,  in  a  language  which  can  be  easily  understood  by  that  authority. 
They shall cooperate with that authority, at its request, on any action taken to eliminate the 
risks posed by products which they have placed on the market. 

Article 7 [Article R3 of Decision No 768/2008/EC] 

Authorised representatives 

1. A manufacturer may, by a written mandate, appoint an authorised representative. 

The obligations laid down in Article 6(1) and the drawing up of technical documentation shall 
not form part of the authorised representative's mandate. 

EN 

26 

   EN 

2. An authorised representative shall perform the tasks specified in the mandate received from 
the  manufacturer.  The  mandate  shall  allow  the  authorised  representative  to  do  at  least  the 
following: 

(a) 

(b) 

(c) 

keep  the  EU  declaration  of  conformity  and  the  technical  documentation  at  the 
disposal of national surveillance authorities for at least 10 years after the product has 
been placed on the market; 

further  to  a  reasoned  request  from  a  competent  national  authority,  provide  that 
authority  with  all  the  information  and  documentation  necessary  to  demonstrate  the 
conformity of a product; 

cooperate  with  the  competent  national  authorities,  at  their  request,  on  any  action 
taken  to  eliminate  the  risks  posed  by  products  covered  by  the  authorised 
representative's mandate. 

Article 8 [Article R4 of Decision No 768/2008/EC] 

1. Importers shall place only compliant products on the Union market. 

Obligations of importers 

2.  Before  placing  a  product  on  the  market  importers  shall  ensure  that  the  appropriate 
conformity assessment procedure has been carried out by the manufacturer. They shall ensure 
that  the  manufacturer  has  drawn  up  the  technical  documentation,  that  the  product  bears  the 
CE  marking  and  the  specific  marking  of  explosion  protection  and  is  accompanied  by  the 
required documents, and that the manufacturer has complied with the requirements set out in 
Article 6(5) and (6). 

Where an importer considers or has reason to believe that a product is not in conformity with 
the essential health and safety requirements set out in Annex II, he shall not place the product 
on  the  market  until  it  has  been  brought  into  conformity.  Furthermore,  where  the  product 
presents  a  risk,  the  importer  shall  inform  the  manufacturer  and  the  market  surveillance 
authorities to that effect. 

3. Importers shall indicate their name and the address at which they can be contacted on the 
product or, where that is not possible, on its packaging or in a document accompanying the 
product. 

4.  Importers  shall  ensure  that  the  product  is  accompanied  by  instructions  and  safety 
information in a language which can be easily understood by end-users, as determined by the 
Member State concerned. 

5.  Importers  shall  ensure  that,  while  a  product  is  under  their  responsibility,  storage  or 
transport  conditions  do  not  jeopardise  its  compliance  with  the  essential  health  and  safety 
requirements set out in Annex II. 

6. Importers who consider or have reason to believe that a product which they have placed on 
the market is not in conformity with the requirements of this Directive shall immediately take 
the  corrective  measures  necessary  to  bring  that  product  into  conformity,  to  withdraw  it  or 

EN 

27 

   EN 

recall  it,  if  appropriate.  Furthermore,  where  the  product  presents  a  risk,  importers  shall 
immediately  inform  the  competent  national  authorities  of  the  Member  States  in  which  they 
made the product available to that effect, giving details, in particular, of the non-compliance 
and of any corrective measures taken. 

7. Importers shall, for at least 10 years after the product has been placed on the market, keep a 
copy of the EU declaration of conformity at the disposal of the market surveillance authorities 
and ensure that the technical documentation can be made available to those authorities, upon 
request. 

8. Importers shall, further to a reasoned request from a competent national authority, provide 
it  with  all  the  information  and  documentation  necessary  to  demonstrate  the  conformity  of  a 
product in a language which can be easily understood by that authority. They shall cooperate 
with that authority, at its request, on any action taken to eliminate the risks posed by products 
which they have placed on the market. 

Article 9 [Article R5 of Decision No 768/2008/EC] 

Obligations of distributors 

1.  When  making  a  product  available  on  the  market  distributors  shall  act  with  due  care  in 
relation to the requirements of this Directive. 

2. Before making a product available on the market or putting it into service distributors shall 
verify that the product bears the CE marking and the specific marking of explosion protection, 
that it is accompanied by the required documents and by instructions in a language which can 
be  easily  understood  by  end-users  in  the  Member  State  in  which  the  product  is  to  be  made 
available on the market, and that the manufacturer and the importer have complied with the 
requirements set out in Article 6(5) and (6) and Article 8(3). 

Where a distributor considers or has reason to believe that a product is not in conformity with 
the essential health and safety requirements set out in Annex II, he shall not make the product 
available  on  the  market  until  it  has  been  brought  into  conformity.  Furthermore,  where  the 
product  presents  a  risk,  the  distributor  shall  inform  the  manufacturer  or  the  importer  to  that 
effect as well as the market surveillance authorities. 

3.  Distributors  shall  ensure  that,  while  a  product  is  under  their  responsibility,  storage  or 
transport  conditions  do  not  jeopardise  its  compliance  with  the  essential  health  and  safety 
requirements set out in Annex II. 

4. Distributors who consider or have reason to believe that a product which they have made 
available  on  the  market  is  not  in  conformity  with  the  requirements  of  this  Directive  shall 
make  sure  that  the  corrective  measures  necessary  to  bring  that  product  into  conformity,  to 
withdraw it or recall it, if appropriate, are taken. Furthermore, where the product presents a 
risk, distributors shall immediately inform the competent national authorities of the Member 
States in which they made the product available to that effect, giving details, in particular, of 
the non-compliance and of any corrective measures taken. 

5.  Distributors  shall,  further  to  a  reasoned  request  from  a  competent  national  authority, 
provide  it  with  all  the  information  and  documentation  necessary  to  demonstrate  the 

EN 

28 

   EN 

conformity of a product. They shall cooperate with that authority, at its request, on any action 
taken to eliminate the risks posed by products which they have made available on the market. 

Article 10 [Article R6 of Decision No 768/2008/EC] 

Cases in which obligations of manufacturers apply to importers and distributors 

An  importer  or  distributor  shall  be  considered  a  manufacturer  for  the  purposes  of  this 
Directive and he shall be subject to the obligations of the manufacturer under Article 6, where 
he places a product on the market under his name or trademark or modifies a product already 
placed on the market in such a way that compliance with the requirements of this Directive 
may be affected. 

Article 11 [Article R7 of Decision No 768/2008/EC] 

Identification of economic operators 

Economic  operators  shall,  on  request,  identify  the  following  to  the  market  surveillance 
authorities, for at least 10 years after the product has been placed on the market: 

(a) 

(b) 

any economic operator who has supplied them with a product; 

any economic operator to whom they have supplied a product. 

Economic operators shall be able to present the information referred to in the first paragraph 
for a period of 10 years after they have been supplied with the product and for a period of 10 
years after they have supplied the product. 

CHAPTER 3 

CONFORMITY OF THE PRODUCT 

Article 12 [Article R8 of Decision No 768/2008/EC] 

Presumption of conformity 

1. Products which are in conformity with harmonised standards or parts thereof the references 
of  which  have  been  published  in  the  Official  Journal  of  the  European  Union  shall  be 
presumed  to  be  in  conformity  with  the  essential  health  and  safety  requirements  covered  by 
those standards or parts thereof, set out in Annex II. 

[Where a harmonised standard satisfies the requirements which it covers and which are set out 
in Annex II or in Article 21, the Commission shall publish the references of those standards in 
the Official Journal of the European Union.] 

EN 

29 

   EN 

2. In the absence  of  harmonizsed standards, Member  States shall take any steps which they 
deem  necessary  to  bring  to  the  attention  of  the  parties  concerned  to  the  existing  national 
technical  standards  and  specifications  regarded  as  important  or  relevant  to  the  proper 
implementation of the essential health and safety requirements ⌦ set out ⌫ in Annex II. 

(cid:208) 94/9/EC (adapted) 

(cid:208) 94/9/EC (adapted) 
(cid:214) new 

Article 813 

⌦ Conformity assessment procedures ⌫ 

1. The procedures ⌦ to be followed ⌫ for assessing the conformity of equipment, including 
where necessary the devices referred to in Article 1 (2), ⌦ products ⌫ shall be as follows: 

(a)  ⌦ for ⌫ equipment-group I and II, equipment-category M 1 and 1 ⌦ , the ⌫ The 
manufacturer or his authorized representative established in the Community must, in 
order  to  affix  the  CE  marking,  follow  the  CE  type-examination  (cid:214) EU-type 
examination  procedure (referred to in Annex III), in conjunction with ⌦ either of 
the following procedures ⌫ : 

– 

– 

the  procedure  relating  to  production  quality  assurance  (cid:214) Conformity  to  type 
based on quality assurance of the production process  (referred to in Annex 
IV),; or 

the  procedure  relating  to  product  verification  (cid:214) Conformity  to  type  based  on 
product verification  (referred to in Annex V); 

(b)  ⌦ for ⌫ eEquipment-group I and II, equipment-category M 2 and 2: 

(i) 

iIn  the  case  of  internal  combustion  engines  and  electrical  equipment  in  these 
groups  and  categories,  the  manufacturer  or  his  authorized  representative 
established in the Community shall, in order to affix the CE mark, follow the 
EC-type  examination  (cid:214) EU-type  examination   procedure  (referred  to  in 
Annex III), in conjunction with ⌦ either of the following procedures ⌫ : 

– 

– 

the procedure relating to conformity to type (cid:214) Conformity to type based 
on internal production control plus supervised product testing  referred 
to in Annex VI; or 

the procedure relating to product quality assurance (cid:214) Conformity to type 
based on product quality assurance  referred to in Annex VII; 

(ii) 

in the case of other equipment in these groups and categories, the manufacturer 
or his authorized representative established in the Community must, in order to 
affix  the  CE  mark,  follow  the  procedure  relating  to  internal  control  of 
production (cid:214) Internal production control  (referred to in Annex VIII) 

EN 

30 

   EN 

 
 
and 

the  communication  of  the  dossier  provided  for  in  Annex  VIII,  paragraph  32,  to  a 
notified  body,  which  shall  acknowledge  receipt  of  it  as  soon  as  possible  and 
shall retain it. 

(c)  ⌦ for ⌫  equipment-group  II,  equipment-category  3  The  manufacturer  or  his 
authorized  representative  established  in  the  Community  must,  in  order  to  affix  the 
CE  marking,  follow,  the  procedure  relating  to  internal  control  of  production 
(cid:214) Internal production control  referred to in Annex VIII; 

(d)  ⌦ for ⌫  equipment-groups  I  and  II,  iIn  addition  to  the  procedures  referred  to  in 
paragraph 1 ⌦ points ⌫ (a), (b) and (c) ⌦ of this paragraph ⌫ , the manufacturer 
or his authorized representative established in the Community may also, in order to 
affix  the  CE  marking,  follow  the  procedure  relating  to  CE  unit  verification 
(cid:214) Conformity  based  on  unit  verification   (referred  to  in  Annex  IX) ⌦ may  also 
be followed ⌫ . 

2. The provisions of 1 ⌦ Procedure referred to in points ⌫ (a) or 1(d) ⌦ of paragraph 1 ⌫ 
above shall be used for conformity assessment of autonomous protective systems. 

(cid:208) 94/9/EC (adapted) 
(cid:206)1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 
(cid:214) new 

3.  The  procedures  referred  to  in  paragraph  1  shall  be  applied  in  respect  of  components  as 
referred to in Article 4 (2)5(2), with the exception of the affixing of the CE marking. (cid:206)1 A 
written  attestation  (cid:214) of  conformity    shall  be  issued  by  the  manufacturer   or  his 
authorized  representative  established  in  the  Community  ⌦ Union ⌫,  declaring  the 
conformity of the components with the provisions of this Directive which apply to them and 
stating their characteristics and how they must be incorporated into equipment or protective 
systems  ⌦ products ⌫  to  assist  compliance  with  the  essential  ⌦ health  and  safety ⌫ 
requirements applicable to finished equipment or protective systems ⌦ products ⌫ . 

(cid:208) 94/9/EC (adapted) 
(cid:214) new 

4. In addition, the manufacturer or his authorized representative established in the Community 
may, in order to affix the CE marking, follow with regard to the safety aspects referred to in 
point  1.2.7  of  Annex  II,  the  procedure  relating  to  internal  control  of  production  (cid:214) Internal 
production control  referred to in Annex VIII ⌦ may be followed ⌫ . 

5. Notwithstanding the previous paragraphs ⌦ By derogation from paragraphs 1 to 4 ⌫ , the 
competent  authorities  may,  on  a  duly  justified  request,  authorize  the  placing  on  the  market 
and  putting  into  service  on  the  territory  of  the  Member  State  concerned  of  the  equipment, 
protective  systems  and  individual  devices  referred  to  in  Article  1  (2)  ⌦ products ⌫  in 
respect of which the procedures referred to in the previous paragraphs ⌦ 1 to 4 ⌫ have not 
been applied and the use of which is in the interests of protection. 

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6.  Documents  and  correspondence  relating 
the 
abovementioned paragraphs ⌦ 1 to 4 ⌫ shall be drawn up in one of the official languages 
of the Member States in which those procedures are being applied or in a language accepted 
by  the  notified  body  ⌦ a  language  easily  understood  by  end-users,  as  determined  by  the 
Member State concerned ⌫ . 

the  procedures  referred 

to 

in 

to 

(cid:208) 94/9/EC 

7. 

(a) 

(b) 

Where the equipment, protective systems and devices referred to in Article 1(2) are 
subject to other Community Directives covering other aspects which also provide for 
the affixing of the CE marking referred to in Article 10, that marking shall indicate 
that the equipment, protective systems and devices referred to in Article 1(2) are also 
presumed to conform with the provisions of those other Directives. 

However,  where  one  or  more  of  those  Directives  allow  the  manufacturer,  during  a 
transitional  period,  to  choose  which  arrangements  to  apply,  the  CE  marking  shall 
indicate  conformity  only  with  the  Directives  applied  by  the  manufacturer.  In  this 
case,  particulars  of  the  said  Directives,  as  published  in  the  Official  Journal  of  the 
European  Communities,  must  be  given  in  the  documents,  notices  or  instructions 
required by the Directives and accompanying the equipment, protective systems and 
devices referred to in Article 1(2).  

(cid:216) new 

Article 14 [Article R10 of Decision No 768/2008/EC] 

EU declaration of conformity 

1. The EU declaration of conformity shall state that the fulfilment of the essential health and 
safety requirements set out in Annex II has been demonstrated. 

2.  The  EU  declaration  of  conformity  shall  have  the  model  structure  set  out  in  Annex  III  of 
Decision  No  768/2008/EC,  shall  contain  the  elements  specified  in  the  relevant  conformity 
assessment procedures set out in Annexes III to IX of this Directive and shall be continuously 
updated. It shall be translated into the language or languages required by the Member State in 
which market the product is made available. 

3.  Where  a  product  is  subject  to  more  than  one  Union  act  requiring  an  EU  declaration  of 
conformity,  a  single  EU  declaration  of  conformity  shall  be  drawn  up  in  respect  of  all  such 
Union acts. That declaration shall contain the identification of the acts concerned, including 
the publication references. 

4.  By  drawing  up  the  EU  declaration  of  conformity,  the  manufacturer  shall  assume  the  full 
responsibility for the compliance of the product. 

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Article 15 [Article R11 of Decision No 768/2008/EC] 

General principles of the CE marking 

The CE marking shall be subject to the general principles set out in Article 30 of Regulation 
(EC) No 765/2008. 

Article 16 [Article R12 of Decision No 768/2008/EC] 

Rules and conditions for affixing the CE marking and the specific marking of explosion 
protection 

1. The CE marking shall be affixed visibly, legibly and indelibly to the product or to its data 
plate. Where that is not possible or not warranted on account of the nature of the product, it 
shall be affixed to the packaging and to the accompanying documents. 

2.  The  CE  marking  shall  be  affixed  before  the  product  is  placed  on  the  market.  It  shall  be 
, followed by the symbol of 
accompanied by the specific marking of explosion protection 
the equipment group and category, as set out in Annex II, point 1.0.5. 

3. The CE marking and the specific marking and symbol referred to in paragraph 2 shall be 
followed by the identification number of the notified body, where that body is involved in the 
production control phase. 

The identification number of the notified body shall be affixed by the body itself or, under its 
instructions, by the manufacturer or his authorised representative. 

4.  The  CE  marking,  the  specific  marking  and  the  symbol  referred  to  in  paragraph  2  and, 
where applicable, the identification number referred to in paragraph 3, may be followed by a 
pictogram or any other mark indicating a special risk or use.  

5. Pictograms or any other mark defined in this Directive may only be used together with the 
CE marking. 

6.  

Equipment and protective systems may be ⌦ Products that are ⌫ designed for a particular 
explosive atmosphere. In this case, they must ⌦ shall ⌫ be marked accordingly. 

(cid:208) 94/9/EC (adapted) 

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(cid:216) new 

CHAPTER 4 

NOTIFICATION OF CONFORMITY ASSESSMENT BODIES 

Article 17 [Article R13 of Decision No 768/2008/EC] 

Notification 

Member States shall notify the Commission and the other Member States of bodies authorised 
to carry out third-party conformity assessment tasks under this Directive. 

Article 18 [Article R14 of Decision No 768/2008/EC] 

Notifying authorities 

1. Member States shall designate a notifying authority that shall be responsible for setting up 
and carrying out the necessary procedures for the assessment and notification of conformity 
assessment  bodies  and  the  monitoring  of  notified  bodies,  including  compliance  with  the 
provisions of Article 23. 

2. Member States may decide that the assessment and monitoring referred to in paragraph 1 
shall be carried out by a national accreditation body within the meaning of and in accordance 
with Regulation (EC) No 765/2008. 

3. Where the notifying authority delegates or otherwise entrusts the assessment, notification 
or  monitoring  referred  to  in  paragraph  1  to  a  body  which  is  not  a  governmental  entity,  that 
body  shall  be  a  legal  entity  and  shall  comply  mutatis  mutandis  with  the  requirements  laid 
down in Article 19(1) to (6). In addition it shall have arrangements to cover liabilities arising 
out of its activities. 

4.  The  notifying  authority  shall  take  full  responsibility  for  the  tasks  performed  by  the  body 
referred to in paragraph 3. 

Article 19 [Article R15 of Decision No 768/2008/EC] 

Requirements relating to notifying authorities 

1.  A  notifying  authority  shall  be  established  in  such  a  way  that  no  conflict  of  interest  with 
conformity assessment bodies occurs. 

2. A notifying authority shall be organised and operated so as to safeguard the objectivity and 
impartiality of its activities. 

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3.  A  notifying  authority  shall  be  organised  in  such  a  way  that  each  decision  relating  to 
notification  of  a  conformity  assessment  body  is  taken  by  competent  persons  different  from 
those who carried out the assessment. 

4.  A  notifying  authority  shall  not  offer  or  provide  any  activities  that  conformity  assessment 
bodies perform or consultancy services on a commercial or competitive basis. 

5. A notifying authority shall safeguard the confidentiality of the information it obtains. 

6. A notifying authority shall have a sufficient number of competent personnel at its disposal 
for the proper performance of its tasks. 

Article 20 [Article R16 of Decision No 768/2008/EC] 

Information obligation on notifying authorities 

Member  States  shall  inform  the  Commission  of  their  procedures  for  the  assessment  and 
notification  of  conformity  assessment  bodies  and  the  monitoring  of  notified  bodies,  and  of 
any changes thereto. 

The Commission shall make that information publicly available. 

Article 21 [Article R17 of Decision No 768/2008/EC] 

Requirements relating to notified bodies 

1. For the purposes of notification, a conformity assessment body shall meet the requirements 
laid down in paragraphs 2 to 11. 

2.  A  conformity  assessment  body  shall  be  established  under  national  law  and  have  legal 
personality. 

3. A conformity assessment body shall be a third-party body independent of the organisation 
or the product it assesses. 

A  body  belonging  to  a  business  association  or  professional  federation  representing 
undertakings involved in the design, manufacturing, provision, assembly, use or maintenance 
of products which it assesses, may, on condition that its independence and the absence of any 
conflict of interest are demonstrated, be considered such a body. 

4. A conformity assessment body, its top level management and the personnel responsible for 
carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, 
installer,  purchaser,  owner,  user  or  maintainer  of  the  products  which  they  assess,  nor  the 
authorised representative of any of those parties. This shall not preclude the use of assessed 
products that are necessary for the operations of the conformity assessment body or the use of 
such products for personal purposes. 

A  conformity  assessment  body,  its  top  level  management  and  the  personnel  responsible  for 
carrying  out  the  conformity  assessment  tasks  shall  not  be  directly  involved  in  the  design, 

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manufacture  or  construction,  the  marketing,  installation,  use  or  maintenance  of  those 
products,  or  represent  the  parties  engaged  in  those  activities.  They  shall  not  engage  in  any 
activity  that  may  conflict  with  their  independence  of  judgement  or  integrity  in  relation  to 
conformity assessment activities for which they are notified. This shall in particular apply to 
consultancy services. 

Conformity  assessment  bodies  shall  ensure  that  the  activities  of  their  subsidiaries  or 
subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity 
assessment activities. 

5.  Conformity  assessment  bodies  and  their  personnel  shall  carry  out  the  conformity 
assessment  activities  with  the  highest  degree  of  professional  integrity  and  the  requisite 
technical  competence  in  the  specific  field  and  shall  be  free  from  all  pressures  and 
inducements,  particularly  financial,  which  might  influence  their  judgement  or  the  results  of 
their conformity assessment activities, especially as regards persons or groups of persons with 
an interest in the results of those activities. 

6.  A  conformity  assessment  body  shall  be  capable  of  carrying  out  all  the  conformity 
assessment  tasks  assigned  to  it  by  Annexes  III  to  IX  and  in  relation  to  which  it  has  been 
notified, whether those tasks are carried out by the conformity assessment body itself or on its 
behalf and under its responsibility. 

At  all  times  and  for  each  conformity  assessment  procedure  and  each  kind  or  category  of 
products in relation to which it has been notified, a conformity assessment body shall have at 
its disposal the necessary: 

(a) 

(b) 

(c) 

personnel  with  technical  knowledge  and  sufficient  and  appropriate  experience  to 
perform the conformity assessment tasks; 

descriptions  of  procedures  in  accordance  with  which  conformity  assessment  is 
carried  out,  ensuring  the  transparency  and  the  ability  of  reproduction  of  those 
procedures. It shall have appropriate policies and procedures in place that distinguish 
between tasks it carries out as a notified body and other activities; 

procedures for the performance of activities which take due account of the size of an 
undertaking, the sector in which it operates, its structure, the degree of complexity of 
the  product  technology  in  question  and  the  mass  or  serial  nature  of  the  production 
process. 

It shall have the means necessary to perform the technical and administrative tasks connected 
with the conformity assessment activities in an appropriate manner and shall have access to 
all necessary equipment or facilities. 

7. The personnel responsible for carrying out conformity assessment activities shall have the 
following: 

(a) 

(b) 

sound  technical  and  vocational  training  covering  all  the  conformity  assessment 
activities in relation to which the conformity assessment body has been notified; 

satisfactory  knowledge  of  the  requirements  of  the  assessments  they  carry  out  and 
adequate authority to carry out those assessments; 

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(c) 

(d) 

appropriate  knowledge  and  understanding  of  the  essential  health  and  safety 
requirements set out in Annex II, of the applicable harmonised standards and of the 
relevant provisions of Union harmonisation legislation and of national legislation; 

the ability to draw up certificates, records and reports demonstrating that assessments 
have been carried out. 

8. The impartiality of the conformity assessment bodies,  their top level management and of 
the assessment personnel shall be guaranteed. 

The  remuneration  of  the  top  level  management  and  assessment  personnel  of  a  conformity 
assessment body shall not depend on the number of assessments carried out or on the results 
of those assessments. 

9. Conformity assessment bodies shall take out liability insurance unless liability is assumed 
by the State in accordance with national law, or the Member State itself is directly responsible 
for the conformity assessment. 

10.  The  personnel  of  a  conformity  assessment body  shall  observe  professional  secrecy  with 
regard to all information obtained in carrying out their tasks under Annexes III to IX or any 
provision of national law giving effect to it, except in relation to the competent authorities of 
the Member State in which its activities are carried out. Proprietary rights shall be protected. 

11.  Conformity  assessment  bodies  shall  participate  in,  or  ensure  that  their  assessment 
personnel  are  informed  of,  the  relevant  standardisation  activities  and  the  activities  of  the 
notified  body  coordination  group  established  under  the  relevant  Union  harmonisation 
legislation  and  apply  as  general  guidance  the  administrative  decisions  and  documents 
produced as a result of the work of that group. 

Article 22 [Article R18 of Decision No 768/2008/EC] 

Presumption of conformity 

Where a conformity assessment body demonstrates its conformity with the criteria laid down 
in  the  relevant  harmonised  standards  or  parts  thereof  the  references  of  which  have  been 
published in the Official Journal of the European Union it shall be presumed to comply with 
the requirements set out in Article 21 in so far as the applicable harmonised standards cover 
those requirements. 

Article 23 [Article R20 of Decision No 768/2008/EC] 

Subsidiaries of and subcontracting by notified bodies 

1. Where a notified body subcontracts specific tasks connected with conformity assessment or 
has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the 
requirements set out in Article 21 and shall inform the notifying authority accordingly. 

2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or 
subsidiaries wherever these are established. 

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37 

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3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of 
the client. 

4. Notified bodies shall keep at the disposal of the notifying authority the relevant documents 
concerning the assessment of the qualifications of the subcontractor or the subsidiary and the 
work carried out by them under Annexes III to IX. 

Article 24 [Article R22 of Decision No 768/2008/EC] 

Application for notification 

1. A conformity assessment body shall submit an application for notification to the notifying 
authority of the Member State in which it is established. 

2.  That  application  shall  be  accompanied  by  a  description  of  the  conformity  assessment 
activities,  the  conformity  assessment  module  or  modules  and  the  product  or  products  for 
which that body claims to be competent, as well as by an accreditation certificate, where one 
exists, issued by a national accreditation body attesting that the conformity assessment body 
fulfils the requirements laid down in Article 21. 

3.  Where  the  conformity  assessment  body  concerned  cannot  provide  an  accreditation 
certificate,  it  shall  provide  the  notifying  authority  with  all  the  documentary  evidence 
necessary for the verification, recognition and regular monitoring of its compliance with the 
requirements laid down in Article 21. 

Article 25 [Article R23 of Decision No 768/2008/EC] 

Notification procedure 

1.  Notifying  authorities  may  notify  only  conformity  assessment  bodies  which  have  satisfied 
the requirements laid down in Article 21. 

2.  They  shall  notify  the  Commission  and  the  other  Member  States  using  the  electronic 
notification tool developed and managed by the Commission. 

3.  The  notification  shall  include  full  details  of  the  conformity  assessment  activities,  the 
conformity  assessment  module  or  modules  and  product  or  products  concerned  and  the 
relevant attestation of competence. 

4. Where a notification is not based on an accreditation certificate as referred to in Article 24, 
the  notifying  authority  shall  provide  the  Commission  and  the  other  Member  States  with 
documentary evidence which attests to the conformity assessment body's competence and the 
arrangements in place to ensure that that body will be monitored regularly and will continue 
to satisfy the requirements laid down in Article 21. 

5. The body concerned may perform the activities of a notified body only where no objections 
are raised by the Commission or the other Member States within two weeks of a notification 
where  an  accreditation  certificate  is  used  or  within  two  months  of  a  notification  where 
accreditation is not used. 

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Only such a body shall be considered a notified body for the purposes of this Directive. 

6. The Commission and the other Member States shall be notified of any subsequent relevant 
changes to the notification. 

Article 26 [Article R24 of Decision No 768/2008/EC] 

Identification numbers and lists of notified bodies 

1. The Commission shall assign an identification number to a notified body. 

It shall assign a single such number even where the body is notified under several Union acts. 

2.  The  Commission  shall  make  publicly  available  the  list  of  the  bodies  notified  under  this 
Directive,  including  the  identification  numbers  that  have  been  allocated  to  them  and  the 
activities for which they have been notified. 

The Commission shall ensure that that list is kept up to date. 

Article 27 [Article R25 of Decision No 768/2008/EC] 

Changes to notifications 

1. Where a notifying authority has ascertained or has been informed that a notified body no 
longer  meets  the  requirements  laid  down  in  Article  21,  or  that  it  is  failing  to  fulfil  its 
obligations,  the  notifying  authority  shall  restrict,  suspend  or  withdraw  notification  as 
appropriate, depending on the seriousness of the failure to meet those requirements or fulfil 
those obligations. It shall immediately inform the Commission and the other Member States 
accordingly. 

2. In the event of restriction, suspension or withdrawal of notification, or where the notified 
body has ceased its activity, the notifying Member State shall take appropriate steps to ensure 
that the files of that body are either processed by another notified body or kept available for 
the responsible notifying and market surveillance authorities at their request. 

Article 28 [Article R26 of Decision No 768/2008/EC] 

Challenge of the competence of notified bodies 

1.  The  Commission  shall  investigate  all  cases  where  it  doubts,  or  doubt  is  brought  to  its 
attention  regarding,  the  competence  of  a  notified  body  or  the  continued  fulfilment  by  a 
notified body of the requirements and responsibilities to which it is subject. 

2. The notifying Member State shall provide the Commission, on request, with all information 
relating  to  the  basis  for  the  notification  or  the  maintenance  of  the  competence  of  the  body 
concerned. 

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3.  The  Commission  shall  ensure  that  all  sensitive  information  obtained  in  the  course  of  its 
investigations is treated confidentially. 

4. Where the Commission ascertains that a notified body does not meet or no longer meets the 
requirements for its notification, it shall inform the notifying Member State accordingly and 
request it to take the necessary corrective measures, including de-notification if necessary. 

Article 29 [Article R27 of Decision No 768/2008/EC] 

Operational obligations of notified bodies 

1. Notified bodies shall carry out conformity assessments in accordance with the conformity 
assessment procedures provided for in Annexes III to IX. 

2.  Conformity  assessments  shall  be  carried  out  in  a  proportionate  manner,  avoiding 
unnecessary  burdens  for  economic  operators.  Conformity  assessment  bodies  shall  perform 
their  activities  taking  due  account  of  the  size  of  an  undertaking,  the  sector  in  which  it 
operates, its structure, the degree of complexity of the product technology in question and the 
mass or serial nature of the production process. 

In  so  doing  they  shall  nevertheless  respect  the  degree  of  rigour  and  the  level  of  protection 
required for the compliance of the product with the provisions of this Directive. 

3.  Where  a  notified  body  finds  that  the  essential  health  and  safety  requirements  set  out  in 
Annex  II  or  corresponding  harmonised  standards  or  technical  specifications  have  not  been 
met  by  a  manufacturer,  it  shall  require  that  manufacturer  to  take  appropriate  corrective 
measures and shall not issue a conformity certificate. 

4. Where, in the course of the monitoring of conformity following the issue of a certificate, a 
notified body finds that a product no longer complies with the requirements laid down in this 
Directive, it shall require the manufacturer to take appropriate corrective measures and shall 
suspend or withdraw the certificate if necessary. 

5.  Where  corrective  measures  are  not  taken  or  do  not  have  the  required  effect,  the  notified 
body shall restrict, suspend or withdraw any certificates, as appropriate. 

Article 30 

Appeal against decisions of notified bodies 

Member States shall ensure that an appeal procedure against decision of the notified bodies is 
available. 

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Article 31 [Article R28 of Decision No 768/2008/EC] 

Information obligation on notified bodies 

1. Notified bodies shall inform the notifying authority of the following: 

(a) 

(b) 

(c) 

(d) 

any refusal, restriction, suspension or withdrawal of a certificate; 

any circumstances affecting the scope of and conditions for notification; 

any  request  for  information  which  they  have  received  from  market  surveillance 
authorities regarding conformity assessment activities; 

on  request,  conformity  assessment  activities  performed  within  the  scope  of  their 
notification  and  any  other  activity  performed,  including  cross-border  activities  and 
subcontracting. 

2.  Notified  bodies  shall  provide  the  other  bodies  notified  under  this  Directive  carrying  out 
similar conformity assessment activities covering the same products with relevant information 
on issues relating to negative and, on request, positive conformity assessment results. 

Article 32 [Article R29 of Decision No 768/2008/EC] 

Exchange of experience 

The  Commission  shall  provide  for  the  organisation  of  exchange  of  experience  between  the 
Member States' national authorities responsible for notification policy. 

Article 33 [Article R30 of Decision No 768/2008/EC] 

Coordination of notified bodies 

The Commission shall ensure that appropriate coordination and cooperation between bodies 
notified under this Directive are put in place and properly operated in the form of a sectoral 
group of notified bodies. 

Member  States  shall  ensure  that  the  bodies  notified  by  them  participate  in  the  work  of  that 
group, directly or by means of designated representatives. 

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CHAPTER 5 

UNION MARKET SURVEILLANCE, CONTROL OF PRODUCTS ENTERING THE UNION 
MARKET AND SAFEGUARD PROCEDURES 

Article 34 

Union market surveillance and control of products entering the Union market 

Article 15(3) and Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to products. 

Article 35 [Article R31 of Decision No 768/2008/EC] 

Procedure for dealing with products presenting a risk at national level 

1. Where the market surveillance authorities of one Member State have taken action pursuant 
to Article 20 of Regulation (EC) No 765/2008, or where they have sufficient reason to believe 
that a product presents a risk to the health or safety of persons or to other aspects of public 
interest protection laid down in this Directive, they shall carry out an evaluation in relation to 
the product concerned covering all the requirements laid down in this Directive. The relevant 
economic operators shall cooperate as necessary with the market surveillance authorities. 

Where,  in  the  course  of  that  evaluation,  the  market  surveillance  authorities  find  that  the 
product does not comply with the requirements laid down in this Directive, they shall without 
delay require the relevant economic operator to take all appropriate corrective action to bring 
the  product  into  compliance  with  those  requirements,  to  withdraw  the  product  from  the 
market, or to recall it within a reasonable period, commensurate with the nature of the risk, as 
they may prescribe. 

The market surveillance authorities shall inform the relevant notified body accordingly. 

Article  21  of  Regulation  (EC)  No  765/2008  shall  apply  to  the  measures  referred  to  in  the 
second subparagraph. 

2. Where the market surveillance authorities consider that non-compliance is not restricted to 
their national territory, they shall inform the Commission and the other Member States of the 
results of the evaluation and of the actions which they have required the economic operator to 
take. 

3. The economic operator shall ensure that all appropriate corrective action is taken in respect 
of all the products concerned that it has made available on the market throughout the Union. 

4. Where the relevant economic operator does not take adequate corrective action within the 
period  referred  to  in  the  second  subparagraph  of  paragraph  1,  the  market  surveillance 
authorities  shall  take  all  appropriate  provisional  measures  to  prohibit  or  restrict  the  being 
made available on their national market, to withdraw the product from that market or to recall 
it. 

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The  market  surveillance  authorities  shall  inform  the  Commission  and  the  other  Member 
States, without delay, of those measures. 

5. The information referred to in paragraph 4 shall include all available details, in particular 
the  data  necessary  for  the  identification  of  the  non-compliant  product,  the  origin  of  the 
product,  the  nature  of  the  non-compliance  alleged  and  the  risk  involved,  the  nature  and 
duration  of  the  national  measures  taken  and  the  arguments  put  forward  by  the  relevant 
economic operator. In particular, the market surveillance authorities shall indicate whether the 
non-compliance is due to any of the following: 

(a) 

(b) 

failure of the product to meet requirements relating to the health or safety of persons 
or to other aspects of public interest protection laid down in this Directive; 

shortcomings  in  the  harmonised  standards  referred  to  in  Annex  II  conferring  a 
presumption of conformity. 

6.  Member  States  other  than  the  Member  State  initiating  the  procedure  shall  without  delay 
inform  the  Commission  and  the  other  Member  States  of  any  measures  adopted  and  of  any 
additional  information  at  their  disposal  relating  to  the  non-compliance  of  the  product 
concerned,  and,  in  the  event  of  disagreement  with  the  notified  national  measure,  of  their 
objections. 

7.  Where,  within  2  months  of  receipt  of  the  information  referred  to  in  paragraph  4,  no 
objection  has  been  raised  by  either  a  Member  State  or  the  Commission  in  respect  of  a 
provisional measure taken by a Member State, that measure shall be deemed justified. 

8. Member States shall ensure that appropriate restrictive measures are taken in respect of the 
product concerned without delay. 

Article 36 [Article R32 of Decision No 768/2008/EC] 

Union safeguard procedure 

1.  Where,  on  completion  of  the  procedure  set  out  in  Article  35(3)  and  (4),  objections  are 
raised  against  a  measure  taken  by  a  Member  State,  or  where  the  Commission  considers  a 
national  measure  to  be  contrary  to  Union  legislation,  the  Commission  shall  without  delay 
enter  into  consultation  with  the  Member  States  and  the  relevant  economic  operator  or 
operators  and  shall  evaluate  the  national  measure.  On  the  basis  of  the  results  of  that 
evaluation, the Commission shall decide whether the national measure is justified or not. 

The  Commission  shall  address  its  decision  to  all  Member  States  and  shall  immediately 
communicate it to them and the relevant economic operator or operators. 

2. If the national measure is considered justified, all Member States shall take the measures 
necessary to ensure that the non-compliant product is withdrawn from their market, and shall 
inform  the  Commission  accordingly.  If  the  national  measure  is  considered  unjustified,  the 
Member State concerned shall withdraw the measure. 

3. Where the national measure is considered justified and the non-compliance of the product 
is attributed to shortcomings in the harmonised standards referred to in Article 35(5)(b) of this 

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Directive, the Commission shall apply the procedure provided for in Article 8 of Regulation 
(EU) No [../..] [on European Standardisation]. 

Article 37 [Article R33 of Decision No 768/2008/EC] 

Compliant products which present a risk to health and safety 

1.  Where,  having  performed  an  evaluation  under  Article  35(1),  a  Member  State  finds  that 
although  a  product  is  in  compliance  with  this  Directive,  it  presents  a  risk  to  the  health  or 
safety of persons or to other aspects of public interest protection laid down in this Directive, it 
shall require the relevant economic operator to take all appropriate measures to ensure that the 
product concerned, when placed on the market, no longer presents that risk, to withdraw the 
product  from  the  market  or  to  recall  it  within  a  reasonable  period,  commensurate  with  the 
nature of the risk, as it may prescribe. 

2.  The  economic  operator  shall  ensure  that  corrective  action  is  taken  in  respect  of  all  the 
products concerned that he has made available on the market throughout the Union. 

3. The Member State shall immediately inform the Commission and the other Member States. 
That  information  shall  include  all  available  details,  in  particular  the  data  necessary  for  the 
identification  of  the  product  concerned,  the  origin  and  the  supply  chain  of  the  product,  the 
nature of the risk involved and the nature and duration of the national measures taken. 

4.  The  Commission  shall  without  delay  enter  into  consultation  with  the  Member  States  and 
the  relevant  economic  operator  or  operators  and  shall  evaluate  the  national  measures  taken. 
On  the  basis  of  the  results  of  that  evaluation,  the  Commission  shall  decide  whether  the 
measure is justified or not, and where necessary, propose appropriate measures. 

5.  The  Commission  shall  address  its  decision  to  all  Member  States  and  shall  immediately 
communicate it to them and the relevant economic operator or operators. 

Article 38 [Article R34 of Decision No 768/2008/EC] 

Formal non-compliance 

1.  Without  prejudice  to  Article  35,  where  a  Member  State  makes  one  of  the  following 
findings, it shall require the relevant economic operator to put an end to the non-compliance 
concerned: 

(a) 

(b) 

(c) 

(d) 

the  CE  marking  or  the  specific  explosion  protection  marking  has  been  affixed  in 
violation  of  Article  30  of  Regulation  (EC)  No  765/2008  or  of  Article  16  of  this 
Directive; 

the CE marking or the specific explosion protection marking has not been affixed; 

the EU declaration of conformity has not been drawn up; 

the EU declaration of conformity has not been drawn up correctly; 

EN 

44 

   EN 

(e) 

technical documentation is either not available or not complete. 

2. Where the non-compliance referred to in paragraph 1 persists, the Member State concerned 
shall take all appropriate measures to restrict or prohibit the product being made available on 
the market or ensure that it is recalled or withdrawn from the market. 

(cid:208) 94/9/EC 

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. 

The Commission shall publish in the Official Journal of the European Communities a list of 
the notified bodies, with their identification numbers and the tasks for which they have been 
notified. The Commission shall ensure that this list is kept up to date. 

2. Member States shall apply the criteria laid down in Annex XI in assessing the bodies to be 
indicated in such notification. Bodies meeting the assessment criteria laid down in the relative 
harmonized standards shall be presumed to fulfil those criteria. 

3. A Member State which has approved a body must withdraw its notification if it finds that 
the body no longer meets the criteria referred to in Annex XI. It shall immediately inform the 
Commission and the other Member States accordingly. 

CHAPTER III 

CE CONFORMITY MARKING 

Article 10 

1. The CE conformity marking shall consist of the initials «CE'». The form of the marking to 
be used is shown in Annex X. The CE marking shall be followed by the identification number 
of the notified body where such body is involved in the production control stage. 

2.  The  CE  marking  shall  be  affixed  distinctly,  visibly,  legibly  and  indelibly  to  equipment, 
protective systems and devices referred to in Article 1(2), supplementary to the provisions of 
point 1.0.5. of Annex II. 

3.  The  affixing  of  markings  on  the  equipment,  protective  systems  or  devices  referred  to  in 
Article  1(2)  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 equipment, protective 
systems or devices referred to in Article 1(2), provided that the visibility and legibility of the 
CE marking is not thereby reduced. 

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45 

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Without prejudice to Article 7: 

Article 11 

(a) 

(b) 

where a Member State establishes that the CE marking has been incorrectly affixed, 
the manufacturer or his authorized representative established within the Community 
shall  be  obliged  to  bring  the  product  into  conformity  as  regards  the  provisions 
concerning  the  CE  marking  and  to  end  the  infringement  under  the  conditions 
imposed by the Member State; 

in  the  event  of  continuing  non-conformity,  the  Member  State  must  take  all 
appropriate measures to restrict or prohibit the placing on the market of the product 
in question or to ensure that it is withdrawn from the market in accordance with the 
procedures laid down in Article 7. 

CHAPTER IV6 

⌦ TRANSITIONAL AND ⌫ FINAL PROVISIONS 

(cid:208) 94/9/EC (adapted) 

(cid:208) 94/9/EC 

Article 12 

Any decision taken pursuant to this Directive which restricts or prohibits the placing on the 
market  and/or  the  putting  into  service  or  requires  the  withdrawal  from  the  market  of 
equipment,  a  protective  system,  or  a  device  referred  to  in  Article  1  (2)  shall  state  the  exact 
grounds  on  which  it  is  based.  Such  a  decision  shall  be  notified  forthwith  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 concerned and of the time limits to which such 
remedies are subject. 

Article 13 

Member States shall ensure that all the parties involved in the application of the Directive are 
bound to observe confidentiality in respect of all information obtained in the performance of 
carrying out their tasks. This does not affect the obligations of the Member States and of the 
notified bodies regarding reciprocal information and the dissemination of warnings. 

EN 

46 

   EN 

 
 
(cid:216) new 

Article 39 

Penalties 

Member States shall lay down rules on penalties applicable to infringements of the national 
provisions adopted pursuant to this Directive and shall take all measures necessary to ensure 
that they are enforced. 

The penalties provided for shall be effective, proportionate and dissuasive. 

Member  States  shall  notify  those  provisions  to  the  Commission  by  [the  date  set  out  in  the 
second  subparagraph  of  Article  40(1)]  and  shall  notify  it  without  delay  of  any  subsequent 
amendment affecting them. 

(cid:208) 94/9/EC (adapted) 
(cid:214) new 

Article 1440 

⌦ Transitional provisions ⌫ 

1. Directive 76/117/EEC, Directive 79/196/EEC17 and Directive 82/130/EEC shall be repealed 
as from 1 July 2003. 

(cid:214) 1. Member States shall not impede the making available on the market or the putting into 
service of products covered by Directive 94/9/EC which are in conformity with that Directive 
and which were placed on the market before [the date set out in the second subparagraph of 
Article 41(1)].  

2. EC Certificates of conformity to the harmonised standards obtained in accordance with the 
procedures  laid  down  in  the  Directives  referred  to  in  paragraph  1  ⌦ issued  pursuant  to 
Article 8 of Directive 94/9/EC ⌫ shall continue to be valid ⌦ under this Directive ⌫ until 
30 June 2003 unless they expire before that date. Their validity shall continue to be limited to 
the harmonised standards indicated in the aforementioned Directives. 

3. Member States shall take the necessary action ⌦ measures ⌫ to ensure that the notified 
bodies which are responsible pursuant to Article 8 (1) to (4)13(1) to (4) for the assessment of 
the  conformity  of  electrical  equipment  ⌦ products ⌫  placed  on  the  market  before  1  July 
2003  (cid:214) [Date]   take  account  of  the  results  of  tests  and  verifications  already  carried  out 
under the Directives referred to in paragraph 1 ⌦ 94/9/EC ⌫ . 

17 

OJ No L 43, 20. 2. 1979, p. 20. Directive as last amended by Directive 90/487/EEC (OJ No L 270, 2. 
10. 1990, p. 23). 

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47 

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(cid:208) 94/9/EC (adapted) 
(cid:214) new 

Article 1541 

⌦ Transposition ⌫ 

1. Member States shall adopt and publish ⌦ by ⌫ (cid:214) [insert date: 2 years after adoption]  
⌦ at  the  latest ⌫  the  laws,  regulations  and  administrative  provisions  necessary  to  comply 
with this Directive ⌦ Article 2(2) and (10) to (26), Article 3, Articles 5 to 40 and Annexes 
III  to  IX ⌫  before  1  September  1995.  They  shall  forthwith  inform ⌦ communicate  to ⌫ 
the Commission thereof ⌦ the text of those provisions and a correlation table between those 
provisions and this Directive ⌫ . 

The  Member  States  ⌦ They ⌫  shall  apply  these  measures  ⌦ those  provisions ⌫  with 
effect from 1 March 1996 ⌦ from [day after the date mentioned in first subparagraph] ⌫. 

When  Member  States  adopt  the  measures  referred  to  in  the  first  subparagraph  ⌦ those 
provisions ⌫,  they  shall  contain  a  reference  to  this  Directive  or  shall  be  accompanied  by 
such  ⌦ a ⌫  reference  at  the  time  ⌦ on  the  occasion ⌫  of  their  official  publication. 
⌦ They  shall  also  include  a  statement  that  references  in  existing  laws,  regulations  and 
administrative  provisions  to  the  Directive  94/9/EC  repealed  by  this  Directive  shall  be 
construed as references to this Directive. ⌫ The methods of making such reference shall be 
laid down by Member States ⌦ shall determine how such reference is to be made and how 
that statement is to be formulated ⌫ . 

2. However, Member States shall allow the placing on the market and the putting into service 
of equipment and protective systems conforming with the national regulations in force in their 
territory at the date of adoption of this Directive for the period until 30 June 2003. 

(cid:208) 94/9/EC 

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

(cid:216) new 

(cid:208)  

Article 42 

Repeal 

Directive 94/9/EC, as amended by the Regulation listed in Annex X, Part A, is repealed with 
effect from [the date set out in the second subparagraph of Article 41(1)], without prejudice to 

EN 

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the obligations of the Member States relating to the time-limits for transposition into national 
law and application of the Directive 94/9/EC set out in Annex X, 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 XI. 

Article 43 

Entry into force 

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

Article 1, Articles 2(1) and (3) to (9), Article 4, Articles 41 to 44 and Annexes I, II, X and XI 
shall apply from [the date set out in the second subparagraph of Article 41(1)]. 

(cid:208) 94/9/EC (adapted) 

Article 1644 

⌦ Addresses ⌫ 

This Directive is addressed to the Member States. 

Done at […], 

For the European Parliament 
The President 

For the Council  
The President  

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49 

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(cid:208) 94/9/EC 

ANNEX I 

CRITERIA DETERMINING THE CLASSIFICATION OF EQUIPMENT-GROUPS 
INTO CATEGORIES 

1. EQUIPMENT-GROUP I 

(a) 

Category  M  1  comprises  equipment  designed  and,  where  necessary,  equipped  with 
additional  special  means  of  protection  to  be  capable  of  functioning  in  conformity 
with the operational parameters established by the manufacturer and ensuring a very 
high level of protection. 

Equipment in this category is intended for use in underground parts of mines as well 
as those parts of surface installations of such mines endangered by firedamp and/or 
combustible dust. 

Equipment in this category is required to remain functional, even in the event of rare 
incidents  relating  to  equipment,  with  an  explosive  atmosphere  present,  and  is 
characterized by means of protection such that: 

– 

– 

either,  in  the  event  of  failure  of  one  means  of  protection,  at  least  an 
independent second means provides the requisite level of protection, 

or  the  requisite  level  of  protection  is  assured  in  the  event  of  two  faults 
occurring independently of each other. 

Equipment  in  this  category  must  comply  with  the  supplementary  requirements 
referred to in Annex II, 2.0.1. 

(b) 

Category  M  2  comprises  equipment  designed  to  be  capable  of  functioning  in 
conformity  with  the  operational  parameters  established  by  the  manufacturer  and 
ensuring a high level of protection. 

Equipment in this category is intended for use in underground parts of mines as well 
as  those  parts  of  surface  installations  of  such  mines  likely  to  be  endangered  by 
firedamp and/or combustible dust. 

This  equipment  is  intended  to  be  de-energized  in  the  event  of  an  explosive 
atmosphere. 

The  means  of  protection  relating  to  equipment  in  this  category  assure  the  requisite 
level  of  protection  during  normal  operation  and  also  in  the  case  of  more  severe 
operating  conditions,  in  particular  those  arising  from  rough  handling  and  changing 
environmental conditions. 

Equipment  in  this  category  must  comply  with  the  supplementary  requirements 
referred to in Annex II, 2.0.2. 

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50 

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2. EQUIPMENT-GROUP II 

(a) 

Category 1 comprises equipment designed to be capable of functioning in conformity 
with the operational parameters established by the manufacturer and ensuring a very 
high level of protection. 

Equipment  in  this  category  is  intended  for  use  in  areas  in  which  explosive 
atmospheres  caused  by  mixtures  of  air  and  gases,  vapours  or  mists  or  by  air/dust 
mixtures are present continuously, for long periods or frequently. 

Equipment in this category must ensure the requisite level of protection, even in the 
event  of  rare  incidents  relating  to  equipment,  and  is  characterized  by  means  of 
protection such that: 

– 

– 

either,  in  the  event  of  failure  of  one  means  of  protection,  at  least  an 
independent second means provides the requisite level of protection, 

or  the  requisite  level  of  protection  is  assured  in  the  event  of  two  faults 
occurring independently of each other. 

Equipment  in  this  category  must  comply  with  the  supplementary  requirements 
referred to in Annex II, 2.1. 

(b) 

Category 2 comprises equipment designed to be capable of functioning in conformity 
with  the  operational  parameters  established  by  the  manufacturer  and  of  ensuring  a 
high level of protection. 

(cid:208) 94/9/EC 
(cid:206)1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 

Equipment  in  this  category  is  intended  for  use  in  areas  in  which  explosive 
atmospheres  caused  by  gases,  vapours,  mists  or  air/dust  mixtures  (cid:206)1 are  likely  to 
occur occasionally.  

(cid:208) 94/9/EC 

The  means  of  protection  relating  to  equipment  in  this  category  ensure  the  requisite 
level  of  protection,  even  in  the  event  of  frequently  occurring  disturbances  or 
equipment faults which normally have to be taken into account. 

Equipment  in  this  category  must  comply  with  the  supplementary  requirements 
referred to in Annex II, 2.2. 

(c) 

Category 3 comprises equipment designed to be capable of functioning in conformity 
with the operating parameters established by the manufacturer and ensuring a normal 
level of protection. 

Equipment  in  this  category  is  intended  for  use  in  areas  in  which  explosive 
atmospheres  caused  by  gases,  vapours,  mists,  or  air/dust  mixtures  are  unlikely  to 

EN 

51 

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occur or, if they do occur, are likely to do so only infrequently and for a short period 
only. 

Equipment  in  this  category  ensures  the  requisite  level  of  protection  during  normal 
operation. 

Equipment  in  this  category  must  comply  with  the  supplementary  requirements 
referred to in Annex II, 2.3. 

(cid:208) 94/9/EC 

ANNEX II 

ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATING TO THE 
DESIGN AND CONSTRUCTION OF EQUIPMENT AND PROTECTIVE SYSTEMS 
INTENDED FOR USE IN POTENTIALLY EXPLOSIVE ATMOSPHERES 

Preliminary observations 

A. Technological knowledge, which can change rapidly, must be taken into account as far as 
possible and be utilized immediately. 

B.  For  the  devices  referred  to  in  Article  1  (2)  ⌦ 1(1)(b) ⌫  ,  the  essential  ⌦ health  and 
safety ⌫  requirements  shall  apply  only  in  so  far  as  they  are  necessary  for  the  safe  and 
reliable functioning and operation of those devices with respect to the risks of explosion. 

(cid:208) 94/9/EC (adapted) 

1. COMMON REQUIREMENTS FOR EQUIPMENT AND PROTECTIVE SYSTEMS 

(cid:208) 94/9/EC 

1.0. General requirements 

1.0.1. Principles of integrated explosion safety 

Equipment and protective systems intended for use in potentially explosive atmospheres must 
be designed from the point of view of integrated explosion safety. 

In this connection, the manufacturer must take measures: 

– 

– 

– 

above all, if possible, to prevent the formation of explosive atmospheres which may 
be produced or released by equipment and by protective systems themselves, 

to  prevent  the  ignition  of  explosive  atmospheres,  taking  into  account  the  nature  of 
every electrical and non-electrical source of ignition, 

should  an  explosion  nevertheless  occur  which  could  directly  or  indirectly  endanger 
persons and, as the case may be, domestic animals or property, to halt it immediately 
and/or to limit the range of explosion flames and explosion pressures to a sufficient 
level of safety. 

EN 

52 

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1.0.2.  Equipment  and  protective  systems  must  be  designed  and  manufactured  after  due 
analysis  of  possible  operating  faults  in  order  as  far  as  possible  to  preclude  dangerous 
situations. 

Any misuse which can reasonably be anticipated must be taken into account. 

1.0.3. Special checking and maintenance conditions 

Equipment  and  protective  systems  subject  to  special  checking  and  maintenance  conditions 
must be designed and constructed with such conditions in mind. 

1.0.4. Surrounding area conditions 

Equipment  and  protective  systems  must  be  so designed  and  constructed  as  to  be  capable  of 
coping with actual or foreseeable surrounding area conditions. 

1.0.5. Marking 

All  equipment  and  protective  systems  must  be  marked  legibly  and  indelibly  with  the 
following minimum particulars: 

– 

name and address of the manufacturer, 

– 

CE marking (see Annex X, point A ⌦ II to Regulation (EC) No 765/2008 ⌫ ), 

(cid:208) 94/9/EC (adapted) 

– 

– 

– 

– 

– 

(cid:208) 94/9/EC 

designation of series or type, 

serial number, if any, 

year of construction, 

the  specific  marking  of  explosion  protection 
equipment group and category, 

  followed  by  the  symbol  of  the 

for  equipment-group  II,  the  letter  'G'  (concerning  explosive  atmospheres  caused  by 
gases, vapours or mists), 

and/or 

the letter 'D' (concerning explosive atmospheres caused by dust). 

Furthermore,  where  necessary,  they  must  also  be  marked  with  all  information  essential  to 
their safe use. 

1.0.6. Instructions 

(a) 

All  equipment  and  protective  systems  must  be  accompanied  by  instructions, 
including at least the following particulars: 

EN 

53 

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– 

a  recapitulation  of  the  information  with  which  the  equipment  or  protective 
system is marked, except for the serial number (see 1.0.5.), together with any 
appropriate additional information to facilitate maintenance (e.g. address of the 
importer, repairer, etc.); 

– 

instructions for safe: 

– 

– 

– 

– 

– 

– 

putting into service, 

use, 

assembling and dismantling, 

maintenance (servicing and emergency repair), 

installation, 

adjustment; 

– 

– 

– 

– 

– 

– 

where  necessary,  an  indication  of  the  danger  areas  in  front  of  pressure-relief 
devices; 

where necessary, training instructions; 

details which allow a decision to be taken beyond any doubt as to whether an 
item  of  equipment  in  a  specific  category  or  a  protective  system  can  be  used 
safely in the intended area under the expected operating conditions; 

electrical  and  pressure  parameters,  maximum  surface  temperatures  and  other 
limit values; 

where  necessary,  special  conditions  of  use,  including  particulars  of  possible 
misuse which experience has shown might occur; 

where  necessary,  the  essential  characteristics  of  tools  which  may  be  fitted  to 
the equipment or protective system. 

(b) 

The  instructions  must  be  drawn  up  in  one  of  the  Community  languages  ⌦ a 
language  easily  understood  by  end-users,  as  determined  by  the  Member  State 
concerned, ⌫ by the manufacturer or his authorized representative established in the 
Community ⌦ Union ⌫ . 

(cid:208) 94/9/EC (adapted) 

On  being  put  into  service,  all  equipment  and  protective  systems  must  be 
accompanied by a translation of the instructions in the language or languages of the 
country  in  which  the  equipment  or  protective  system  is  to  be  used  and  by  the 
instructions in the original language. 

This  translation  must  be  made  by  either  the  manufacturer  or  his  authorized 
representative established in the Community ⌦ Union ⌫ or the person introducing 
the equipment or protective system into the language area in question. 

EN 

54 

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By way of derogation from this requirement, the maintenance instructions for use by 
the  manufacturer  or  his  authorized 
the  specialist  personnel  employed  by 
representative  established  in  the  Community  ⌦ Union ⌫  may  be  drawn  up  in  a 
single Community ⌦ Union ⌫ language understood by that personnel. 

(cid:208) 94/9/EC 

(c) 

The  instructions  must  contain  the  drawings  and  diagrams  necessary  for  the  putting 
into  service,  maintenance,  inspection,  checking  of  correct  operation  and,  where 
appropriate,  repair  of  the  equipment  or  protective  system,  together  with  all  useful 
instructions, in particular with regard to safety. 

(d) 

Literature  describing  the  equipment  or  protective  system  must  not  contradict  the 
instructions with regard to safety aspects. 

1.1. Selection of materials 

1.1.1. The materials used for the construction of equipment and protective systems must not 
trigger off an explosion, taking into account foreseeable operational stresses. 

1.1.2. Within the limits of the operating conditions laid down by the manufacturer, it must not 
be possible for a reaction to take place between the materials used and the constituents of the 
potentially explosive atmosphere which could impair explosion protection. 

(cid:208) 94/9/EC 
(cid:206)1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 

1.1.3. Materials must be so selected that predictable changes in their characteristics and their 
compatibility in combination with other materials will not lead to a reduction in the protection 
afforded;  in  particular,  due  account  must  be  taken  of  the  material's  corrosion  and  wear 
resistance,  (cid:206)1 electrical  conductivity,  mechanical  strength,  ageing  resistance  and  the 
effects of temperature variations. 

1.2. Design and Construction 

(cid:208) 94/9/EC 

1.2.1. Equipment and protective systems must be designed and constructed with due regard to 
technological  knowledge  of  explosion  protection  so  that  they  can  be  safely  operated 
throughout their foreseeable lifetime. 

1.2.2.  Components  to  be  incorporated  into  or  used  as  replacements  in  equipment  and 
protective  systems  must  be  so  designed  and  constructed  that  they  function  safely  for  their 
intended  purpose  of  explosion  protection  when  they  are  installed  in  accordance  with  the 
manufacturer's instructions. 

1.2.3. Enclosed structures and prevention of leaks 

Equipment  which  may  release  flammable  gases  or  dusts  must  wherever  possible  employ 
enclosed structures only. 

EN 

55 

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(cid:208) 94/9/EC 
(cid:206)1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 

If equipment contains openings or non-tight joints, these must as far as possible be designed 
in (cid:206)1 such a way that releases of gases or dusts  cannot give rise to explosive atmospheres 
outside the equipment. 

Points where materials are introduced or drawn off must, as far as possible, be designed and 
equipped (cid:206)1 so as to limit releases of flammable materials  during filling or draining. 

1.2.4. Dust deposits 

(cid:208) 94/9/EC 

Equipment  and  protective  systems  which  are  intended  to  be  used  in  areas  exposed  to  dust 
must be so designed that deposit dust on their surfaces is not ignited. 

In general, dust deposits must be limited where possible. Equipment and protective systems 
must be easily cleanable. 

The surface temperatures of equipment parts must be kept well below the glow temperature of 
the deposit dust. 

The thickness of deposit dust must be taken into consideration and, if appropriate, means must 
be taken to limit the temperature in order to prevent a heat build up. 

1.2.5. Additional means of protection 

Equipment and protective systems which may be exposed to certain types of external stresses 
must be equipped, where necessary, with additional means of protection. 

Equipment must withstand relevant stresses, without adverse effect on explosion protection. 

1.2.6. Safe opening 

If equipment and protective systems are in a housing or a locked container forming part of the 
explosion protection itself, it must be possible to open such housing or container only with a 
special tool or by means of appropriate protection measures. 

1.2.7. Protection against other hazards 

Equipment and protective systems must be so designed and manufactured as to: 

(a) 

(b) 

avoid  physical  injury  or  other  harm  which  might  be  caused  by  direct  or  indirect 
contact; 

assure that surface temperatures of accessible parts or radiation which would cause a 
danger, are not produced; 

(c) 

eliminate non-electrical dangers which are revealed by experience; 

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(cid:208) 94/9/EC 
(cid:206)1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 

(d) 

assure that (cid:206)1 foreseeable  conditions  of  overload  do  not  give  rise   to  dangerous 
situations. 

Where,  for  equipment  and  protective  systems,  the  risks  referred  to  in  this  paragraph  are 
wholly  or  partly  covered  by  other  Community ⌦ Union ⌫  Directives,  this  Directive  shall 
not apply or shall cease to apply in the case of such equipment and protective systems and of 
such risks upon application of those specific Directives. 

(cid:208) 94/9/EC (adapted) 

1.2.8. Overloading of equipment 

(cid:208) 94/9/EC 

Dangerous  overloading  of  equipment  must  be  prevented  at  the  design  stage  by  means  of 
integrated measurement, regulation and control devices, such as over-current cut-off switches, 
temperature  limiters,  differential  pressure  switches,  flowmeters,  time-lag  relays,  overspeed 
monitors and/or similar types of monitoring devices. 

1.2.9. Flameproof enclosure systems 

If parts which can ignite an explosive atmosphere are placed in an enclosure, measures must 
be  taken  to  ensure  that  the  enclosure  withstands  the  pressure  developed  during  an  internal 
explosion  of  an  explosive  mixture  and  prevents  the  transmission  of  the  explosion  to  the 
explosive atmosphere surrounding the enclosure. 

1.3. Potential ignition sources 

1.3.1. Hazards arising from different ignition sources 

Potential  ignition  sources  such  as  sparks,  flames,  electric  arcs,  high  surface  temperatures, 
acoustic energy, optical radiation, electromagnetic waves and other ignition sources must not 
occur. 

1.3.2. Hazards arising from static electricity 

Electrostatic  charges  capable  of  resulting  in  dangerous  discharges  must  be  prevented  by 
means of appropriate measures. 

1.3.3. Hazards arising from stray electric and leakage currents 

Stray  electric  and  leakage  currents  in  conductive  equipment  parts  which  could  result  in,  for 
example, the occurrence of dangerous corrosion, overheating of surfaces or sparks capable of 
provoking an ignition must be prevented. 

EN 

57 

   EN 

 
 
 
1.3.4. Hazards arising from overheating 

Overheating  caused  by  friction  or  impacts  occurring,  for  example,  between  materials  and 
parts in contact with each other while rotating or through the intrusion of foreign bodies must, 
as far as possible, be prevented at the design stage. 

1.3.5. Hazards arising from pressure compensation operations 

Equipment  and  protective  systems  must  be  so  designed  or  fitted  with  integrated  measuring, 
control and regulation devices that pressure compensations arising from them do not generate 
shock waves or compressions which may cause ignition. 

1.4. Hazards arising from external effects 

1.4.1. Equipment and protective systems must be so designed and constructed as to be capable 
of  performing  their  intended  function  in  full  safety,  even  in  changing  environmental 
conditions  and  in  the  presence  of  extraneous  voltages,  humidity,  vibrations,  contamination 
and  other  external  effects,  taking  into  account  the  limits  of  the  operating  conditions 
established by the manufacturer. 

1.4.2.  Equipment  parts  used  must  be  appropriate  to  the  intended  mechanical  and  thermal 
stresses and capable of withstanding attack by existing or foreseeable aggressive substances. 

1.5. Requirements in respect of safety-related devices 

(cid:208) 94/9/EC 
(cid:206)1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 

1.5.1.  Safety  devices  must  function  (cid:206)1 independently  of  any  measurement  and/or  control 
devices  required for operation. 

As  far  as  possible,  failure  of  a  safety  device  must  be  detected  sufficiently  rapidly  by 
appropriate technical means to ensure that there is only very little likelihood that dangerous 
situations will occur. 

(cid:206)1 The fail-safe principle  is to be applied in general. 

(cid:208) 94/9/EC 

Safety-related switching must in general directly actuate the relevant control devices without 
intermediate software command. 

1.5.2.  In  the  event  of  a  safety  device  failure,  equipment  and/or  protective  systems  shall, 
wherever possible, be secured. 

1.5.3. Emergency stop controls of safety devices must, as far as possible, be fitted with restart 
lockouts.  A  new  start  command  may  take  effect  on  normal  operation  only  after  the  restart 
lockouts have been intentionally reset. 

EN 

58 

   EN 

 
 
1.5.4. Control and display units 

Where  control  and  display  units  are  used,  they  must  be  designed  in  accordance  with 
ergonomic  principles  in  order  to  achieve  the  highest  possible  level  of  operating  safety  with 
regard to the risk of explosion. 

1.5.5. Requirements in respect of devices with a measuring function for explosion protection 

In so far as they relate to equipment used in explosive atmospheres, devices with a measuring 
function must be designed and constructed so that they can cope with foreseeable operating 
requirements and special conditions of use. 

1.5.6. Where necessary, it must be possible to check the reading accuracy and serviceability 
of devices with a measuring function. 

1.5.7. The design of devices with a measuring function must incorporate a safety factor which 
ensures that the alarm threshold lies far enough outside the explosion and/or ignition limits of 
the atmospheres to be registered, taking into account, in particular, the operating conditions of 
the installation and possible aberrations in the measuring system. 

1.5.8. Risks arising from software 

In the design of software-controlled equipment, protective systems and safety devices, special 
account must be taken of the risks arising from faults in the programme. 

1.6. Integration of safety requirements relating to the system 

1.6.1. Manual override must be possible in order to shut down the equipment and protective 
systems incorporated within automatic processes which deviate from the intended operating 
conditions, provided that this does not compromise safety. 

1.6.2.  When  the  emergency  shutdown  system  is  actuated,  accumulated  energy  must  be 
dispersed  as  quickly  and  as  safely  as  possible  or  isolated  so  that  it  no  longer  constitutes  a 
hazard. 

This does not apply to electrochemically-stored energy. 

1.6.3. Hazards arising from power failure 

Where equipment and protective systems can give rise to a spread of additional risks in the 
event  of  a  power  failure,  it  must  be  possible  to  maintain  them  in  a  safe  state  of  operation 
independently of the rest of the installation. 

1.6.4. Hazards arising from connections 

Equipment and protective systems must be fitted with suitable cable and conduit entries. 

When  equipment  and  protective  systems  are  intended  for  use  in  combination  with  other 
equipment and protective systems, the interface must be safe. 

EN 

59 

   EN 

1.6.5. Placing of warning devices as parts of equipment 

Where  equipment  or  protective  systems  are  fitted  with  detection  or  alarm  devices  for 
monitoring  the  occurrence  of  explosive  atmospheres,  the  necessary  instructions  must  be 
provided to enable them to be provided at the appropriate places. 

2. SUPPLEMENTARY REQUIREMENTS IN RESPECT OF EQUIPMENT 

2.0. Requirements applicable to equipment in category M of equipment-group I 

2.0.1. Requirements applicable to equipment in category M 1 of equipment-group I 

2.0.1.1.  Equipment  must  be  so  designed  and  constructed  that  sources  of  ignition  do  not 
become active, even in the event of rare incidents relating to equipment. 

Equipment must be equipped with means of protection such that: 

– 

– 

either,  in  the  event  of  failure  of  one  means  of  protection,  at  least  an  independent 
second means provides the requisite level of protection, 

or,  the  requisite  level  of  protection  is  ensured  in  the  event  of  two  faults  occurring 
independently of each other. 

Where  necessary,  this  equipment  must  be  equipped  with  additional  special  means  of 
protection. 

It must remain functional with an explosive atmosphere present. 

2.0.1.2. Where necessary, equipment must be so constructed that no dust can penetrate it. 

2.0.1.3. The surface temperatures of equipment parts must be kept clearly below the ignition 
temperature of the foreseeable air/dust mixtures in order to prevent the ignition of suspended 
dust. 

2.0.1.4.  Equipment  must  be  so  designed  that  the  opening  of  equipment  parts  which  may  be 
sources of ignition is possible only under non-active or intrinsically safe conditions. Where it 
is not possible to render equipment non-active, the manufacturer must affix a warning label to 
the opening part of the equipment. 

If necessary, equipment must be fitted with appropriate additional interlocking systems. 

2.0.2. Requirements applicable to equipment in category M 2 of equipment-group I 

2.0.2.1.  Equipment  must  be  equipped  with  means  of  protection  ensuring  that  sources  of 
ignition  do  not  become  active  during  normal  operation,  even  under  more  severe  operating 
conditions,  in  particular  those  arising  from  rough  handling  and  changing  environmental 
conditions. 

The equipment is intended to be de-energized in the event of an explosive atmosphere. 

2.0.2.2.  Equipment  must  be  so  designed  that  the  opening  of  equipment  parts  which  may  be 
sources of ignition is possible only under non-active conditions or via appropriate interlocking 

EN 

60 

   EN 

systems. Where it is not possible to render equipment non-active, the manufacturer must affix 
a warning label to the opening part of the equipment. 

2.0.2.3.  The  requirements  regarding  explosion  hazards  arising  from  dust  applicable  to 
category M 1 must be applied. 

2.1. Requirements applicable to equipment in category 1 of equipment-group II 

(cid:208) 94/9/EC 
(cid:206)1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 

2.1.1. (cid:206)1 Explosive atmospheres caused by gases, vapours or mists  

(cid:208) 94/9/EC 

2.1.1.1.  Equipment  must  be  so  designed  and  constructed  that  sources  of  ignition  do  not 
become active, even in event of rare incidents relating to equipment. 

It must be equipped with means of protection such that: 

– 

– 

either,  in  the  event  of  failure  of  one  means  of  protection,  at  least  an  independent 
second means provides the requisite level of protection, 

or,  the  requisite  level  of  protection  is  ensured  in  the  event  of  two  faults  occurring 
independently of each other. 

2.1.1.2. For equipment with surfaces which may heat up, measures must be taken to ensure 
that the stated maximum surface temperatures are not exceeded even in the most unfavourable 
circumstances. 

Temperature  rises  caused  by  heat  build-ups  and  chemical  reactions  must  also  be  taken  into 
account. 

2.1.1.3. Equipment must be so designed that the opening of equipment parts which might be 
sources of ignition is possible only under non-active or intrinsically safe conditions. Where it 
is not possible to render equipment non-active, the manufacturer must affix a warning label to 
the opening part of the equipment. 

If necessary, equipment must be fitted with appropriate additional interlocking systems. 

2.1.2. Explosive atmospheres caused by air/dust mixtures 

2.1.2.1.  Equipment  must  be  so  designed  and  constructed  that  ignition  of  air/dust  mixtures 
does not occur even in the event of rare incidents relating to equipment. 

It must be equipped with means of protection such that 

– 

either,  in  the  event  of  failure  of  one  means  of  protection,  at  least  an  independent 
second means provides the requisite level of protection, 

EN 

61 

   EN 

 
 
– 

or,  the  requisite  level  of  protection  is  ensured  in  the  event  of  two  faults  occurring 
independently of each other. 

2.1.2.2. Where necessary, equipment must be so designed that dust can enter or escape from 
the equipment only at specifically designated points. 

This requirement must also be met by cable entries and connecting pieces. 

2.1.2.3.  The  surface  temperatures  of  equipment  parts  must  be  kept  well  below  the  ignition 
temperature of the foreseeable air/dust mixtures in order to prevent the ignition of suspended 
dust. 

2.1.2.4. With regard to the safe opening of equipment parts, requirement 2.1.1.3 applies. 

2.2. Requirements for category 2 of equipment-group II 

2.2.1. Explosive atmospheres caused by gases, vapours or mists 

2.2.1.1. Equipment must be so designed and constructed as to prevent ignition sources arising, 
even in the event of frequently occurring disturbances or  equipment operating faults, which 
normally have to be taken into account. 

2.2.1.2.  Equipment  parts  must  be  so  designed  and  constructed  that  their  stated  surface 
temperatures  are  not  exceeded,  even  in  the  case  of  risks  arising  from  abnormal  situations 
anticipated by the manufacturer. 

2.2.1.3. Equipment must be so designed that the opening of equipment parts which might be 
sources of ignition is possible only under non-active conditions or via appropriate interlocking 
systems. Where it is not possible to render equipment non-active, the manufacturer must affix 
a warning label to the opening part of the equipment. 

2.2.2. Explosive atmospheres caused by air/dust mixtures 

2.2.2.1. Equipment must be designed and constructed so that ignition of air/dust mixtures is 
prevented,  even  in  the  event  of  frequently  occurring  disturbances  or  equipment  operating 
faults which normally have to be taken into account. 

2.2.2.2. With regard to surface temperatures, requirement 2.1.2.3 applies. 

2.2.2.3. With regard to protection against dust, requirement 2.1.2.2 applies. 

2.2.2.4. With regard to the safe opening of equipment parts, requirement 2.2.1.3 applies. 

2.3. Requirements applicable to equipment in category 3 of equipment-group II 

2.3.1. Explosive atmospheres caused by gases, vapours or mists 

2.3.1.1.  Equipment  must  be  so  designed  and  constructed  as  to  prevent  foreseeable  ignition 
sources which can occur during normal operation. 

2.3.1.2.  Surface  temperatures  must  not  exceed  the  stated  maximum  surface  temperatures 
under intended operating conditions. Higher  temperatures in  exceptional  circumstances may 
be allowed only if the manufacturer adopts special additional protective measures. 

EN 

62 

   EN 

2.3.2. Explosive atmospheres caused by air/dust mixtures 

2.3.2.1.  Equipment  must  be  so  designed  and  constructed  that  air/dust  mixtures  cannot  be 
ignited by foreseeable ignition sources likely to exist during normal operation. 

2.3.2.2. With regard to surface temperatures, requirement 2.1.2.3 applies. 

2.3.2.3.  Equipment,  including  cable  entries  and  connecting  pieces,  must  be  so  constructed 
that, taking into account the size of its particles, dust can neither develop explosive mixtures 
with air nor form dangerous accumulations inside the equipment. 

3. SUPPLEMENTARY REQUIREMENTS IN RESPECT OF PROTECTIVE SYSTEMS 

3.0. General requirements 

3.0.1.  Protective  systems  must  be  dimensioned  in  such  a  way  as  to  reduce  the  effects  of  an 
explosion to a sufficient level of safety. 

(cid:208) 94/9/EC 
(cid:206)1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 

3.0.2.  Protective  systems  must  be  designed  and  (cid:206)1 capable  of  being  positioned  in  such  a 
way   that  explosions  are  prevented  from  spreading  through  dangerous  chain  reactions  or 
flashover and incipient explosions do not become detonations. 

3.0.3. In the event of a power failure, protective systems must retain their capacity to function 
for a period sufficient to avoid a dangerous situation. 

3.0.4. Protective systems must not fail due to outside interference. 

(cid:208) 94/9/EC 

3.1. Planning and design 

3.1.1. Characteristics of materials 

With regard to the characteristics of materials, the maximum pressure and temperature to be 
taken into consideration at the planning stage are the expected pressure during an explosion 
occurring under extreme operating conditions and the anticipated heating effect of the flame. 

3.1.2.  Protective  systems  designed  to  resist  or  contain  explosions  must  be  capable  of 
withstanding the shock wave produced without losing system integrity. 

3.1.3.  Accessories  connected  to  protective  systems  must  be  capable  of  withstanding  the 
expected maximum explosion pressure without losing their capacity to function. 

3.1.4.  The  reactions  caused  by  pressure  in  peripheral  equipment  and  connected  pipe-work 
must be taken into consideration in the planning and design of protective systems. 

EN 

63 

   EN 

 
 
3.1.5. Pressure-relief systems 

If it is likely that stresses on protective systems will exceed their structural strength, provision 
must be made in the design for suitable pressure-relief devices which do not endanger persons 
in the vicinity. 

3.1.6. Explosion suppression systems 

(cid:208) 94/9/EC 
(cid:206)1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 

Explosion suppression systems must be so planned and designed that they react to an incipient 
explosion at the earliest possible stage in the event of an incident and counteract it (cid:206)1 to best 
effect,  with  due  regard  to   the  maximum  rate  of  pressure  increase  and  the  maximum 
explosion pressure. 

3.1.7. Explosion decoupling systems 

(cid:208) 94/9/EC 

Decoupling  systems  intended  to  disconnect  specific  equipment  as  swiftly  as  possible  in  the 
event of incipient explosions by means of appropriate devices must be planned and designed 
so  as  to  remain  proof  against  the  transmission  of  internal  ignition  and  to  retain  their 
mechanical strength under operating conditions. 

3.1.8.  Protective  systems  must  be  capable  of  being  integrated  into  a  circuit  with  a  suitable 
alarm  threshold  so  that,  if  necessary,  there  is  cessation  of  product  feed  and  output  and 
shutdown of equipment parts which can no longer function safely. 

(cid:208) 94/9/EC 

ANNEX III 

MODULE EC-TYPE EXAMINATION 

1. This module describes that part of the procedure by which a notified body ascertains and 
attests  that  a  specimen  representative  of  the  production  envisaged  meets  the  relevant 
applicable provisions of the Directive. 

2.  The  application  for  the  EC-type  examination  shall  be  lodged  by  the  manufacturer  or  his 
authorized  representative  established  within  the  Community  with  a  notified  body  of  his 
choice. 

The application shall include: 

– 

– 

EN 

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  same  application  has  not  been  lodged  with  any  other 
notified body; 

64 

   EN 

 
 
 
– 

the technical documentation, as described in point 3. 

The applicant shall place at the disposal of the notified body a specimen representative of the 
production  envisaged  and  hereinafter  called  «type».  The  notified  body  may  request  further 
specimens if needed for carrying out the test programme. 

3.  The  technical  documentation  shall  enable  the  conformity  of  the  product  with  the 
requirements  of  the  Directive  to  be  assessed.  It  shall,  to  the  extent  necessary  for  such 
assessment,  cover  the  design,  manufacture  and  operation  of  the  product  and  shall  to  that 
extent contain: 

– 

– 

– 

– 

– 

– 

a general type-description; 

design  and  manufacturing  drawings  and  layouts  of  components,  sub-assemblies, 
circuits, etc.; 

descriptions and explanations necessary for the understanding of said drawings and 
layouts and the operation of the product; 

a  list  of  the  standards  referred  to  in  Article  5,  applied  in  full  or  in  part,  and 
descriptions  of  the  solutions  adopted  to  meet  the  essential  requirements  of  the 
Directive where the standards referred to in Article 5 have not been applied; 

results of design calculations made, examinations carried out, etc.; 

test reports. 

4. The notified body shall: 

4.1.  examine  the  technical  documentation,  verify  that  the  type  has  been  manufactured  in 
conformity  with  the  technical  documentation  and  identify  the  elements  which  have  been 
designed in accordance with the relevant provisions of the standards referred to in Article 5, 
as well as the components which have been designed without applying the relevant provisions 
of those standards; 

4.2.  perform  or  have  performed  the  appropriate  examinations  and  necessary  tests  to  check 
whether  the  solutions  adopted  by  the  manufacturer  meet  the  essential  requirements  of  the 
Directive where the standards referred to in Article 5 have not been applied; 

4.3.  perform  or  have  performed  the  appropriate  examinations  and  necessary  tests  to  check 
whether  these  have  actually  been  applied,  where  the  manufacturer  has  chosen  to  apply  the 
relevant standards; 

4.4. agree with the applicant the location where the examinations and necessary tests shall be 
carried out. 

5. Where the type meets the provisions of the Directive, the notified body shall issue an EC-
type-examination  certificate  to  the  applicant.  The  certificate  shall  contain  the  name  and 
address  of  the  manufacturer,  conclusions  of  the  examination  and  the  necessary  data  for 
identification of the approved type. 

EN 

65 

   EN 

A list of the significant parts of the technical documentation shall be annexed to the certificate 
and a copy kept by the notified body. 

If the manufacturer or his authorized representative established in the Community is denied a 
type certification, the notified body shall provide detailed reasons for such denial. 

Provision shall be made for an appeals procedure. 

6.  The  applicant  shall  inform  the  notified  body  which  holds  the  technical  documentation 
concerning  the  EC-type-examination  certificate  of  all  modifications  to  the  approved 
equipment or protective system which must receive further approval where such changes may 
affect conformity with the essential requirements or with the prescribed conditions for use of 
the product. This further approval is given in the form of an addition to the original EC-type-
examination certificate. 

7. Each notified body shall communicate to the other notified bodies the relevant information 
concerning the EC-type-examination certificates and additions issued and withdrawn. 

8.  The  other  notified  bodies  may  receive  copies  of  the  EC-type-examination  certificates 
and/or their additions. The annexes to the certificates shall be kept at the disposal of the other 
notified bodies. 

9. The manufacturer or his authorized representative established in the Community shall keep 
with  the  technical  documentation  copies  of  EC-type-examination  certificates  and  their 
additions  for  a  period  ending  at  least  10  years after  the  last  equipment  or  protective  system 
was manufactured. 

Where  neither  the  manufacturer  nor  his  authorized  representative  is  established  within  the 
Community,  the  obligation  to  keep  the  technical  documentation  available  shall  be  the 
responsibility of the person who places the product on the Community market. 

MODULE: EU-TYPE EXAMINATION 

(cid:216) new 

1. EU-type examination is the part of a conformity assessment procedure in which a notified 
body  examines  the  technical  design  of  a  product  and  verifies  and  attests  that  the  technical 
design of the product meets the requirements of this Directive that apply to it. 

2.  EU-type  examination  shall  be  carried  out  with  the  examination  of  a  specimen, 
representative of the production envisaged, of the complete product (production type). 

3. The manufacturer shall lodge an application for EU-type examination with a single notified 
body of his choice. 

The application shall include: 

– 

– 

EN 

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

a  written  declaration  that  the  same  application  has  not  been  lodged  with  any  other 
notified body, 

66 

   EN 

 
– 

– 

– 

the technical documentation. The technical documentation shall make it possible to 
assess  the  product's  conformity  with  the  applicable  requirements  of  this  Directive 
and  shall  include  an  adequate  analysis  and  assessment  of  the  risk(s).  The  technical 
documentation shall specify the applicable requirements and cover, as far as relevant 
for  the  assessment,  the  design,  manufacture  and  operation  of  the  product.  The 
technical documentation shall contain at least the following elements: 

– 

– 

– 

– 

– 

– 

a general description of the product, 

conceptual  design  and  manufacturing  drawings  and  schemes  of  components, 
sub-assemblies, circuits, etc., 

descriptions  and  explanations  necessary  for  the  understanding  of  those 
drawings and schemes and the operation of the product, 

a list of the harmonised standards and/or other relevant technical specifications 
the  references  of  which  have  been  published  in  the  Official  Journal  of  the 
European  Union,  applied  in  full  or  in  part,  and  descriptions  of  the  solutions 
adopted to meet the essential health and safety requirements of this Directive 
where those harmonised standards have not been applied. In the event of partly 
applied  harmonised  standards,  the  technical  documentation  shall  specify  the 
parts which have been applied, 

results of design calculations made, examinations carried out, etc., and 

test reports, 

the  specimens  representative  of  the  production  envisaged.  The  notified  body  may 
request further specimens if needed for carrying out the test programme, 

the  supporting  evidence  for  the  adequacy  of  the  technical  design  solution.  This 
supporting evidence shall mention any documents that have been used, in particular 
where  the  relevant  harmonised  standards  and/or  technical  specifications  have  not 
been  applied  in  full.  The  supporting  evidence  shall  include,  where  necessary,  the 
results  of  tests  carried  out  by  the  appropriate  laboratory  of  the  manufacturer,  or  by 
another testing laboratory on his behalf and under his responsibility. 

4. The notified body shall: 

4.1.  verify  that  the  specimen(s)  have  been  manufactured  in  conformity  with  the  technical 
documentation, and identify  the elements which have been designed in accordance  with the 
applicable provisions of the relevant harmonised standards and/or technical specifications, as 
well  as  the  elements  which  have  been  designed  without  applying  the  relevant  provisions  of 
those standards; 

4.2. carry out appropriate examinations and tests, or have them carried out, to check whether, 
where  the  manufacturer  has  chosen  to  apply  the  solutions  in  the  relevant  harmonised 
standards and/or technical specifications, these have been applied correctly; 

4.3. carry out appropriate examinations and tests, or have them carried out, to check whether, 
where the solutions in the relevant harmonised standards and/or technical specifications have 

EN 

67 

   EN 

not been applied, the solutions adopted by the manufacturer meet the corresponding essential 
health and safety requirements of this Directive; 

4.4.  agree  with  the  manufacturer  on  a  location  where  the  examinations  and  tests  will  be 
carried out. 

5. The notified body shall draw up an evaluation report that records the activities undertaken 
in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à vis 
the notifying authorities, the notified body shall release the content of that report, in full or in 
part, only with the agreement of the manufacturer. 

6.  Where  the  type  meets  the  requirements  of  this  Directive  that  apply  to  the  product 
concerned,  the  notified  body  shall  issue  an  EU-type  examination  certificate  to  the 
manufacturer.  The  certificate  shall  contain  the  name  and  address  of  the  manufacturer,  the 
conclusions of the examination, the conditions (if any) for its validity and the necessary data 
for  identification  of  the  approved  type.  The  certificate  may  have  one  or  more  annexes 
attached. 

The certificate and its annexes shall contain all relevant information to allow the conformity 
of manufactured products with the examined type to be evaluated and to allow for in-service 
control. 

Where  the  type  does  not  satisfy  the  applicable  requirements  of  this  Directive,  the  notified 
body shall refuse to issue an EU-type examination certificate and shall inform the applicant 
accordingly, giving detailed reasons for its refusal. 

7. The notified body shall keep itself apprised of any changes in the generally acknowledged 
state  of  the  art  which  indicate  that  the  approved  type  may  no  longer  comply  with  the 
applicable requirements of this Directive, and shall determine whether such changes require 
further investigation. If so, the notified body shall inform the manufacturer accordingly. 

The  manufacturer  shall  inform  the  notified  body  that  holds  the  technical  documentation 
relating to the EU-type examination certificate of all modifications to the approved type that 
may affect the conformity of the product with the essential health and safety requirements of 
this Directive or the conditions for validity of the certificate. Such modifications shall require 
additional approval in the form of an addition to the original EU-type examination certificate. 

8.  Each  notified  body  shall  inform  its  notifying  authorities  concerning  the  EU-type 
examination  certificates  and/or  any  additions  thereto  which  it  has  issued  or  withdrawn,  and 
shall,  periodically  or  upon  request,  make  available  to  its  notifying  authorities  the  list  of 
certificates and/or any additions thereto refused, suspended or otherwise restricted. 

Each notified body shall inform the other notified bodies concerning the EU-type examination 
certificates  and/or  any  additions  thereto  which  it  has  refused,  withdrawn,  suspended  or 
otherwise  restricted,  and,  upon  request,  concerning  the  certificates  and/or  additions  thereto 
which it has issued. 

The Commission, the Member States and the other notified bodies may, on request, obtain a 
copy  of  the  EU-type  examination  certificates  and/or  additions  thereto.  On  request,  the 
Commission  and  the  Member  States  may  obtain  a  copy  of  the  technical  documentation  and 
the results of the examinations carried out by the notified body. The notified body shall keep a 
copy  of  the  EU-type  examination  certificate,  its  annexes  and  additions,  as  well  as  the 

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technical file including the documentation submitted by the manufacturer, until the expiry of 
the validity of the certificate. 

9. The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and 
additions together with the technical documentation at the disposal of the national authorities 
for 10 years after the product has been placed on the market. 

10.  The  manufacturer's  authorised  representative  may  lodge  the  application  referred  to  in 
point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in 
the mandate. 

(cid:208) 94/9/EC 

ANNEX IV 

MODULE: PRODUCTION QUALITY ASSURANCE 

1.  This  module  describes  the  procedure  whereby  the  manufacturer  who  satisfies  the 
obligations of point 2 ensures and declares that the products concerned are in conformity with 
the  type  as  described  in  the  EC-type-examination  certificate  and  satisfy  the  requirements  of 
the  Directive  which  apply  to  them.  The  manufacturer,  or  his  authorized  representative 
established  in  the  Community,  shall  affix  the  CE  marking  to  each  piece  of  equipment  and 
draw  up  a  written  declaration  of  conformity.  The  CE  marking  shall  be  accompanied  by  the 
identification  number  of  the  notified  body  responsible  for  EC  monitoring,  as  specified  in 
Section 4. 

2. The manufacturer shall operate an approved quality system for production, final equipment 
inspection and testing as specified in Section 3 and shall be subject to monitoring as specified 
in Section 4. 

3. QUALITY SYSTEM 

3.1. The manufacturer shall lodge an application for assessment of his quality system with a 
notified body of his choice, for the equipment concerned. 

The application shall include: 

– 

– 

– 

all relevant information for the product category envisaged; 

the documentation concerning the quality system; 

technical  documentation  on  the  approved  type  and  a  copy  of  the  EC-type-
examination certificate. 

3.2. The quality system shall ensure compliance of the equipment with the type as described 
in the EC-type-examination certificate and with the requirements of the Directive which apply 
to them. 

All  the  elements,  requirements  and  provisions  adopted  by  the  manufacturer  shall  be 
documented  in  a  systematic  and  orderly  manner  in  the  form  of  written  policies,  procedures 

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and instructions. The quality system documentation must permit a consistent interpretation of 
quality programmes, plans, manuals and records. 

It shall contain, in particular, an adequate description of 

– 

– 

– 

– 

– 

the quality objectives and the organizational structure, responsibilities and powers of 
the management with regard to equipment quality; 

the  manufacturing,  quality  control  and  quality  assurance  techniques,  processes  and 
systematic actions which will be used; 

the  examinations  and  tests  which  will  be  carried  out  before,  during  and  after 
manufacture and the frequency with which they will be carried out; 

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

the  means  to  monitor  the  achievement  of  the  required  equipment  quality  and  the 
effective operation of the quality system. 

3.3.  The  notified  body  shall  assess  the  quality  system  to  determine  whether  it  satisfies  the 
requirements referred to in Section 3.2. It shall presume conformity with these requirements 
in respect of quality systems which implement the relevant harmonized standard. The auditing 
team  shall  have  at  least  one  member  with  experience  of  evaluation  in  the  equipment 
technology  concerned.  The  evaluation  procedure  shall  include  an  inspection  visit  to  the 
manufacturer's premises. The decision shall be notified to the manufacturer. The notification 
shall contain the conclusions of the examination and the reasoned assessment decision. 

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system 
as approved and to uphold the system so that it remains adequate and efficient. 

The  manufacturer  or  his  authorized  representative  shall  inform  the  notified  body  which  has 
approved the quality system of any intended updating of the quality system. 

The notified body shall evaluate the modifications proposed and decide whether the amended 
quality  system  will  still  satisfy  the  requirements  referred  to  in  Section  3.2  or  whether  a  re-
assessment is required. 

It shall notify its decision to the manufacturer. The notification shall contain the conclusions 
of the examination and the reasoned assessment decision. 

4. SURVEILLANCE UNDER THE RESPONSIBILITY OF THE NOTIFIED BODY 

4.1.  The  purpose  of  surveillance  is  to  make  sure  that  the  manufacturer  duly  fulfils  the 
obligations arising out of the approved quality system. 

4.2.  The  manufacturer  shall,  for  inspection  purposes,  allow  the  notified  body  access  to  the 
manufacture, inspection, testing and storage premises and shall provide it with all necessary 
information, in particular 

– 

the quality system documentation 

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– 

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

4.3.  The  notified  body  shall  periodically  carry  out  audits  to  ensure  that  the  manufacturer 
maintains and applies the quality system and shall provide an audit report to the manufacturer. 

4.4.  Furthermore,  the  notified  body  may  pay  unexpected  visits  to  the  manufacturer.  During 
such  visits,  the  notified  body  may  carry  out  tests,  or  arrange  for  tests  to  be  carried  out,  to 
check  that  the  quality  system  is  functioning  correctly,  if  necessary.  The  notified  body  shall 
provide the manufacturer with a visit report and, if a test has taken place, with a test report. 

5.  The  manufacturer  shall,  for  a  period  ending  at  least  10  years  after  the  last  piece  of 
equipment was manufactured, keep at the disposal of the national authorities: 

– 

– 

– 

the documentation referred to in the second indent of Section 3.1; 

the updating referred to in the second paragraph of Section 3.4; 

the decisions and reports from the notified body which are referred to in Section 3.4, 
last paragraph, Section 4.3 and Secton 4.4. 

6.  Each  notified  body  shall  apprise  the  other  notified  bodies  of  the  relevant  information 
concerning the quality system approvals issued and withdrawn. 

(cid:216) new 

MODULE: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE 
PRODUCTION PROCESS 

1.  Conformity  to  type  based  on  quality  assurance  of  the  production  process  is  the  part  of  a 
conformity assessment procedure whereby the manufacturer fulfils the obligations laid down 
in  points  2  and  5,  and  ensures  and  declares  on  his  sole  responsibility  that  the  products 
concerned  are  in  conformity  with  the  type  described  in  the  EU-type  examination  certificate 
and satisfy the requirements of this Directive that apply to them. 

2. Manufacturing 

The  manufacturer  shall  operate  an  approved  quality  system  for  production,  final  product 
inspection and testing of the products concerned as specified in point 3, and shall be subject to 
surveillance as specified in point 4. 

3. Quality system 

3.1. The manufacturer shall lodge an application for assessment of his quality system with the 
notified body of his choice, for the products concerned. 

The application shall include: 

– 

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

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– 

– 

– 

– 

a  written  declaration  that  the  same  application  has  not  been  lodged  with  any  other 
notified body, 

all relevant information for the product category envisaged, 

the documentation concerning the quality system, 

the  technical  documentation  of  the  approved  type  and  a  copy  of  the  EU-type 
examination certificate. 

3.2.  The  quality  system  shall  ensure  that  the  products  are  in  conformity  with  the  type 
described  in  the  EU-type  examination  certificate  and  comply  with  the  requirements  of  this 
Directive that apply to them. 

All  the  elements,  requirements  and  provisions  adopted  by  the  manufacturer  shall  be 
documented  in  a  systematic  and  orderly  manner  in  the  form  of  written  policies,  procedures 
and instructions. The quality system documentation shall permit a consistent interpretation of 
the quality programmes, plans, manuals and records. 

It shall, in particular, contain an adequate description of: 

– 

– 

– 

– 

– 

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

the  corresponding  manufacturing,  quality  control  and  quality  assurance  techniques, 
processes 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  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 
qualification reports on the personnel concerned, etc., and 

the  means  of  monitoring  the  achievement  of  the  required  product  quality  and  the 
effective operation of the quality system. 

3.3.  The  notified  body  shall  assess  the  quality  system  to  determine  whether  it  satisfies  the 
requirements referred to in point 3.2. 

It shall presume conformity with those requirements in respect of the elements of the quality 
system  that  comply  with  the  corresponding  specifications  of  the  national  standard  that 
implements the relevant harmonised standard and/or technical specifications. 

In addition to experience in quality management systems, the auditing team shall have at least 
one  member  with  experience  of  evaluation  in  the  relevant  product  field  and  product 
technology  concerned,  and  knowledge  of  the  applicable  requirements  of  this  Directive.  The 
audit shall include an assessment visit to the manufacturer's premises. The auditing team shall 
review  the  technical  documentation  referred  to  in  point  3.1,  fifth  indent,  to  verify  the 
manufacturer's ability to identify the relevant requirements of this Directive and to carry out 
the  necessary  examinations  with  a  view  to  ensuring  compliance  of  the  product  with  those 
requirements. 

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The  decision  shall  be  notified  to  the  manufacturer.  The  notification  shall  contain  the 
conclusions of the audit and the reasoned assessment decision. 

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system 
as approved and to maintain it so that it remains adequate and efficient. 

3.5.  The  manufacturer  shall  keep  the  notified  body  that  has  approved  the  quality  system 
informed of any intended change to the quality system. 

The  notified  body  shall  evaluate  any  proposed  changes  and  decide  whether  the  modified 
quality system will continue to satisfy the requirements referred to in point 3.2 or whether a 
reassessment is necessary. 

It shall notify the manufacturer of its decision. The notification shall contain the conclusions 
of the examination and the reasoned assessment decision. 

4. Surveillance under the responsibility of the notified body 

4.1.  The  purpose  of  surveillance  is  to  make  sure  that  the  manufacturer  duly  fulfils  the 
obligations arising out of the approved quality system. 

4.2.  The  manufacturer  shall,  for  assessment  purposes,  allow  the  notified  body  access  to  the 
manufacture,  inspection,  testing  and  storage  sites  and  shall  provide  it  with  all  necessary 
information, in particular: 

– 

– 

the quality system documentation, 

the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 
qualification reports on the personnel concerned, etc. 

4.3.  The  notified  body  shall  carry  out  periodic  audits  to  make  sure  that  the  manufacturer 
maintains  and  applies  the  quality  system  and  shall  provide  the  manufacturer  with  an  audit 
report. 

4.4. In addition, the notified body may pay unexpected visits to the manufacturer. During such 
visits the notified body may, if necessary, carry out product tests, or have them carried out, in 
order to verify that the quality system is functioning correctly. The notified body shall provide 
the manufacturer with a visit report and, if tests have been carried out, with a test report. 

5. Conformity marking and declaration of conformity 

5.1. The manufacturer shall affix the required conformity markings set out in this Directive, 
and,  under  the  responsibility  of  the  notified  body  referred  to  in  point  3.1,  the  latter's 
identification number to each individual product that is in conformity with the type described 
in  the  EU-type  examination  certificate  and  satisfies  the  applicable  requirements  of  this 
Directive. 

5.2.  The  manufacturer  shall  draw  up  a  written  declaration  of  conformity  for  each  product 
model and keep it at the disposal of the national authorities for 10 years after the product has 
been placed on the market. The declaration of conformity shall identify the product model for 
which it has been drawn up. 

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A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

6.  The  manufacturer  shall,  for  a  period  ending  at  least  10  years  after  the  product  has  been 
placed on the market, keep at the disposal of the national authorities: 

– 

– 

– 

the documentation referred to in point 3.1, 

the change referred to in point 3.5, as approved, 

the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4. 

7. Each notified body shall inform its notifying authorities of quality system approvals issued 
or  withdrawn,  and  shall,  periodically  or  upon  request,  make  available  to  its  notifying 
authorities the list of quality system approvals refused, suspended or otherwise restricted. 

Each notified body shall inform the other notified bodies of quality system approvals which it 
has  refused,  suspended,  withdrawn  or  otherwise  restricted,  and,  upon  request,  of  quality 
system approvals which it has issued. 

8. Authorised representative 

The  manufacturer's  obligations  set  out  in  points  3.1,  3.5,  5  and  6  may  be  fulfilled  by  his 
authorised  representative,  on  his  behalf  and  under  his  responsibility,  provided  that  they  are 
specified in the mandate. 

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(cid:208) 94/9/EC 

ANNEX V 

MODULE: PRODUCT VERIFICATION 

1.  This  module  describes  the  procedure  whereby  a  manufacturer  or  his  authorized 
representative  established  within  the  Community  checks  and  attests  that  the  equipment 
subject to the provisions of point 3 are in conformity with  the type as described in the EC-
type-examination certificate and satisfy the relevant requirements of the Directive. 

2.  The  manufacturer  shall  take  all  measures  necessary  to  ensure  that  the  manufacturing 
process  guarantees  conformity  of  the  equipment  with  the  type  as  described  in  the  EC-type-
examination certificate and with the requirements of the Directive which apply to them. The 
manufacturer or his authorized representative established in the Community shall affix the CE 
marking to each piece of equipment and shall draw up a declaration of conformity. 

3. The notified body shall carry out the appropriate examinations and tests in order to check 
the conformity of the equipment, protective system or device referred to in Article 1 (2), with 
the  relevant  requirements  of  the  Directive,  by  examining  and  testing  every  product  as 
specified in Section 4. 

The  manufacturer  or  his  authorized  representative  shall  keep  a  copy  of  the  declaration  of 
conformity  for  a  period  ending  at  least  10  years  after  the  last  piece  of  equipment  was 
manufactured. 

4. VERIFICATION BY EXAMINATION AND TESTING OF EACH PIECE OF EQUIPMENT. 

4.1.  All  equipment  shall  be  individually  examined  and  appropriate  tests  as  set  out  in  the 
relevant standard(s) referred to in Article 5 or equivalent tests shall be carried out in order to 
verify their conformity with the type as described in the EC-type-examination certificate and 
the relevant requirements of the Directive. 

4.2. The notified body shall affix or have affixed its identification number to each approved 
item of equipment and shall draw up a written certificate of conformity relating to the tests 
carried out. 

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

(cid:216) new 

MODULE: CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION 

1.  Conformity  to  type  based  on  product  verification  is  the  part  of  a  conformity  assessment 
procedure whereby the manufacturer fulfils the obligations laid down in points 2, 5.1 and 6, 
and ensures  and declares on  his  sole responsibility that the products concerned, which have 
been subject to the provisions of point 3, are in conformity with the type described in the EU-
type examination certificate and satisfy the requirements of this Directive that apply to them. 

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2. Manufacturing 

The manufacturer shall take all measures necessary so that the manufacturing process and its 
monitoring ensure conformity of the manufactured products with the approved type described 
in the EU-type examination certificate and with the requirements of this Directive that apply 
to them. 

3. Verification 

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests 
in order to check the conformity of the products with the approved type described in the EU-
type examination certificate and with the appropriate requirements of this Directive. 

The  examinations  and  tests  to  check  the  conformity  of  the  products  with  the  appropriate 
requirements shall be carried out by examination and testing of every product as specified in 
point 4. 

4. Verification of conformity by examination and testing of every product 

4.1. All products shall be individually examined and appropriate tests set out in the relevant 
harmonised standard(s) and/or technical specifications, or equivalent tests, shall be carried out 
in  order  to  verify  conformity  with  the  approved  type  described  in  the  EU-type  examination 
certificate and with the appropriate requirements of this Directive. 

In the absence of such a harmonised standard, the notified body concerned shall decide on the 
appropriate tests to be carried out. 

4.2.  The  notified  body  shall  issue  a  certificate  of  conformity  in  respect  of  the  examinations 
and  tests  carried  out,  and  shall  affix  its  identification  number  to  each  approved  product  or 
have it affixed under its responsibility. 

The  manufacturer  shall  keep  the  certificates  of  conformity  available  for  inspection  by  the 
national authorities for 10 years after the product has been placed on the market. 

5. Conformity marking and declaration of conformity 

5.1. The manufacturer shall affix the required conformity markings set out in this Directive, 
and,  under  the  responsibility  of  the  notified  body  referred  to  in  point  3,  the  latter's 
identification number to each individual product that is in conformity with the approved type 
described in the EU-type examination certificate and satisfies the applicable requirements of 
this Directive. 

5.2.  The  manufacturer  shall  draw  up  a  written  declaration  of  conformity  for  each  product 
model and keep it at the disposal of the national authorities, for 10 years after the product has 
been placed on the market. The declaration of conformity shall identify the product model for 
which it has been drawn up. 

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer 
may also affix the notified body's identification number to the products. 

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6.  If  the  notified  body  agrees  and  under  its  responsibility,  the  manufacturer  may  affix  the 
notified body's identification number to the products during the manufacturing process. 

7. Authorised representative 

The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf 
and under his  responsibility,  provided  that they are  specified  in  the  mandate.  An  authorised 
representative may not fulfil the manufacturer's obligations set out in point 2. 

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(cid:208) 94/9/EC 

ANNEX VI 

MODULE: CONFORMITY TO TYPE 

1.  This  module  describes  that  part  of  the  procedure  whereby  the  manufacturer  or  his 
authorized  representative  established  within  the  Community  ensures  and  declares  that  the 
equipment in question is in conformity with the type as described in the EC-type-examination 
certificate and satisfies the requirements of the Directive applicable to it. The manufacturer or 
his authorized representative established within the Community shall affix the CE marking to 
each piece of equipment and draw up a written declaration of conformity. 

2.  The  manufacturer  shall  take  all  measures  necessary  to  ensure  that  the  manufacturing 
process assures compliance of the manufactured equipment with the type as described in the 
EC-type-examination certificate and with the relevant requirements of the Directive. 

3. The manufacturer or his authorized representative shall keep a copy of the declaration of 
conformity  for  a  period  ending  at  least  10  years  after  the  last  piece  of  equipment  was 
manufactured. Where neither the manufacturer nor his authorized representative is established 
within the Community, the obligation to keep the technical documentation available shall be 
the  responsibility  of  the  person  who  places  the  equipment  or  protective  system  on  the 
Community market. 

For  each  piece  of  equipment  manufactured,  tests  relating  to  the  anti-explosive  protection 
aspects of the product shall be carried out by the manufacturer or on his behalf. The tests shall 
be carried out under the responsibility of a notified body, chosen by the manufacturer. 

On  the  responsibility  of  the  notified  body,  the  manufacturer  shall  affix  the  former's 
identification number during the manufacturing process. 

(cid:216) new 

MODULE: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION 
CONTROL PLUS SUPERVISED PRODUCT TESTING 

1. Conformity to type based on internal production control plus supervised product testing is 
the  part  of  a  conformity  assessment  procedure  whereby  the  manufacturer  fulfils  the 
obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility 
that  the  products  concerned  are  in  conformity  with  the  type  described  in  the  EU-type 
examination certificate and satisfy the requirements of this Directive that apply to them. 

2. Manufacturing 

The manufacturer shall take all measures necessary so that the manufacturing process and its 
monitoring  ensure  conformity  of  the  manufactured  products  with  the  type  described  in  the 
EU-type  examination  certificate  and  with  the  requirements  of  this  Directive  that  apply  to 
them. 

3. Product checks 

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For each individual product manufactured one or more tests on one or more specific aspects 
of  the  product  shall  be  carried  out  by  the  manufacturer  or  on  his  behalf,  in  order  to  verify 
conformity  with  the  type  described  in  the  EU-type  examination  certificate  and  with  the 
corresponding  requirements  of  this  Directive.  The  tests  shall  be  carried  out  under  the 
responsibility of a notified body, chosen by the manufacturer. 

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

4. Conformity marking and declaration of conformity 

4.1. The manufacturer shall affix the required conformity markings set out in this Directive to 
each  individual  product  that  is  in  conformity  with  the  type  described  in  the  EU-type 
examination certificate and satisfies the applicable requirements of this Directive. 

4.2. The manufacturer shall draw up a written declaration of conformity for a product model 
and keep it at the disposal of the national authorities for 10 years after the product has been 
placed  on  the  market.  The  declaration  of  conformity  shall  identify  the  product  model  for 
which it has been drawn up. 

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

5. Authorised representative 

The  manufacturer's  obligations  set  out  in  point  4  may  be  fulfilled  by  his  authorised 
representative, on his behalf and under his responsibility, provided that they are specified in 
the mandate. 

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(cid:208) 94/9/EC 

ANNEX VII 

MODULE: PRODUCT QUALITY ASSURANCE 

1.  This  module  describes  the  procedure  whereby  the  manufacturer  who  satisfies  the 
obligations  of  Section  2  ensures  and  declares  that  the  equipment  is  in  conformity  with  the 
type as described in the EC-type-examination certificate. The manufacturer or his authorized 
representative established within the Community shall affix the CE marking to each product 
and draw up a written declaration of conformity. The CE marking shall be accompanied by 
the  identification  number  of  the  notified  body  responsible  for  surveillance  as  specified  in 
Section 4. 

2.  The  manufacturer  shall  operate  an  approved  quality  system  for  the  final  inspection  and 
testing  of  equipment  as  specified  in  Section  3  below  and  shall  be  subject  to  surveillance  as 
specified in Section 4 below. 

3. QUALITY SYSTEM 

3.1. The manufacturer shall lodge an application for assessment of his quality system for the 
equipment, with a notified body of his choice.  

The application shall include: 

– 

– 

– 

all relevant information for the product category envisaged; 

documentation on the quality system; 

technical  documentation  on  the  approved  type  and  a  copy  of  the  EC-type-
examination certificate. 

3.2.  Under  the  quality  system,  each  piece  of  equipment  shall  be  examined  and  appropriate 
tests as set out in the relevant standard(s) referred to in Article 5 or equivalent tests shall be 
carried out in order to ensure its conformity with the relevant requirements of the Directive. 
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 must permit a consistent interpretation of 
the quality programmes, plans, manuals and records. 

It shall contain, in particular, an adequate description of: 

– 

– 

– 

– 

the quality objectives and the organizational structure, responsibilities and powers of 
the management with regard to product quality; 

the examinations and tests which will be carried out after manufacture; 

the means to monitor the effective operation of the quality system; 

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

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3.3.  The  notified  body  shall  assess  the  quality  system  to  determine  whether  it  satisfies  the 
requirements referred to in Section 3.2. It shall presume conformity with these requirements 
in respect of quality systems which implement the relevant harmonized standard. 

The auditing team shall have at least one member experienced as an assessor in the product 
technology  concerned.  The  assessment  procedure  shall  include  an  assessment  visit  to  the 
manufacturer's premises. 

The  decision  shall  be  notified  to  the  manufacturer.  The  notification  shall  contain  the 
conclusions of the examination and the reasoned assessment decision. 

3.4.  The  manufacturer  shall  undertake  to  discharge  the  obligations  arising  from  the  quality 
system as approved and to maintain it in an appropriate and efficient manner. 

The  manufacturer  or  his  authorized  representative  shall  inform  the  notified  body  which  has 
approved the quality system of any intended updating of the quality system. 

The notified body shall evaluate the modifications proposed and decide whether the modified 
quality  system  will  still  satisfy  the  requirements  referred  to  in  Section  3.2  or  whether  a  re-
assessment is required. 

It shall notify its decision to the manufacturer. The notification shall contain the conclusions 
of the examination and the reasoned assessment decision. 

4. SURVEILLANCE UNDER THE RESPONSIBILITY OF THE NOTIFIED BODY 

4.1. The purpose of surveillance is to ensure that the manufacturer duly fulfils the obligations 
arising out of the approved quality system. 

4.2.  The  manufacturer  shall  for  inspection  purposes  allow  the  notified  body  access  to  the 
inspection, testing and storage premises and shall provide it with all necessary information, in 
particular: 

– 

– 

– 

quality system documentation; 

technical documentation; 

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

4.3.  The  notified  body  shall  periodically  carry  out  audits  to  ensure  that  the  manufacturer 
maintains and applies the quality system and shall provide an audit report to the manufacturer. 

4.4.  Furthermore,  the  notified  body  may  pay  unexpected  visits  to  the  manufacturer.  At  the 
time of such visits, the notified body may carry out tests or arrange for tests to be carried out 
in  order  to  check  the  proper  functioning  of  the  quality  system,  where  necessary;  it  shall 
provide  the  manufacturer  with  a  visit  report  and,  if  a  test  has  been  carried  out,  with  a  test 
report. 

5.  The  manufacturer  shall,  for  a  period  ending  at  least  10  years  after  the  last  piece  of 
equipment was manufactured, keep at the disposal of the national authorities: 

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– 

– 

– 

the documentation referred to in the third indent of Section 3.1; 

the updating referred to in the second paragraph of Section 3.4; 

the decisions and reports from the notified body which are referred to in Section 3.4, 
last paragraph, Section 4.3 and Section 4.4. 

6.  Each  notified  body  shall  forward  to  the  other  notified  bodies  the  relevant  information 
concerning the quality system approvals issued and withdrawn. 

MODULE: CONFORMITY TO TYPE BASED ON PRODUCT QUALITY 
ASSURANCE 

(cid:216) new 

1.  Conformity  to  type  based  on  product  quality  assurance  is  that  part  of  a  conformity 
assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 
and 5, and ensures and declares on his sole responsibility that the products concerned are in 
conformity  with  the  type  described  in  the  EU-type  examination  certificate  and  satisfy  the 
requirements of this Directive that apply to them. 

2. Manufacturing 

The  manufacturer  shall  operate  an  approved  quality  system  for  final  product  inspection  and 
testing of the products concerned as specified in point 3 and shall be subject to surveillance as 
specified in point 4. 

3. Quality system 

3.1. The manufacturer shall lodge an application for assessment of his quality system with the 
notified body of his choice, for the products concerned. 

The application shall include: 

– 

– 

– 

– 

– 

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

a  written  declaration  that  the  same  application  has  not  been  lodged  with  any  other 
notified body, 

all relevant information for the product category envisaged, 

the documentation concerning the quality system, and 

the  technical  documentation  of  the  approved  type  and  a  copy  of  the  EU-type 
examination certificate. 

3.2. The quality system shall ensure compliance of the products with the type described in the 
EU-type examination certificate and with the applicable requirements of this Directive. 

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 

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and instructions. The quality system documentation shall permit a consistent interpretation of 
the quality programmes, plans, manuals and records. 

It shall, in particular, contain an adequate description of: 

– 

– 

– 

– 

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

the examinations and tests that will be carried out after manufacture, 

the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 
qualification reports on the personnel concerned, etc., 

the means of monitoring the effective operation of the quality system. 

3.3.  The  notified  body  shall  assess  the  quality  system  to  determine  whether  it  satisfies  the 
requirements referred to in point 3.2. 

It shall presume conformity with those requirements in respect of the elements of the quality 
system  that  comply  with  the  corresponding  specifications  of  the  national  standard  that 
implements the relevant harmonised standard and/or technical specification. 

In addition to experience in quality management systems, the auditing team shall have at least 
one  member  with  experience  of  evaluation  in  the  relevant  product  field  and  product 
technology  concerned,  and  knowledge  of  the  applicable  requirements  of  this  Directive.  The 
audit shall include an assessment visit to the manufacturer's premises. The auditing team shall 
review the technical documentation referred to in point 3.1, fifth indent, in order to verify the 
manufacturer's ability to identify the relevant requirements of this Directive and to carry out 
the  necessary  examinations  with  a  view  to  ensuring  compliance  of  the  product  with  those 
requirements. 

The  decision  shall  be  notified  to  the  manufacturer.  The  notification  shall  contain  the 
conclusions of the audit and the reasoned assessment decision. 

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system 
as approved and to maintain it so that it remains adequate and efficient. 

3.5.  The  manufacturer  shall  keep  the  notified  body  that  has  approved  the  quality  system 
informed of any intended change to the quality system. 

The  notified  body  shall  evaluate  any  proposed  changes  and  decide  whether  the  modified 
quality system will continue to satisfy the requirements referred to in point 3.2 or whether a 
reassessment is necessary. 

It shall notify the manufacturer of its decision. The notification shall contain the conclusions 
of the examination and the reasoned assessment decision. 

4. Surveillance under the responsibility of the notified body 

4.1.  The  purpose  of  surveillance  is  to  make  sure  that  the  manufacturer  duly  fulfils  the 
obligations arising out of the approved quality system. 

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4.2.  The  manufacturer  shall,  for  assessment  purposes,  allow  the  notified  body  access  to  the 
manufacture,  inspection,  testing  and  storage  sites  and  shall  provide  it  with  all  necessary 
information, in particular: 

– 

– 

the quality system documentation, 

the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 
qualification reports on the personnel concerned, etc. 

4.3.  The  notified  body  shall  carry  out  periodic  audits  to  make  sure  that  the  manufacturer 
maintains  and  applies  the  quality  system  and  shall  provide  the  manufacturer  with  an  audit 
report. 

4.4. In addition, the notified body may pay unexpected visits to the manufacturer. During such 
visits the notified body may, if necessary, carry out product tests, or have them carried out, in 
order to verify that the quality system is functioning correctly. The notified body shall provide 
the manufacturer with a visit report and, if tests have been carried out, with a test report. 

5. Conformity marking and declaration of conformity 

5.1. The manufacturer shall affix the required conformity markings set out in this Directive, 
and,  under  the  responsibility  of  the  notified  body  referred  to  in  point  3.1,  the  latter's 
identification number to each individual product that is in conformity with the type described 
in  the  EU-type  examination  certificate  and  satisfies  the  applicable  requirements  of  this 
Directive. 

5.2.  The  manufacturer  shall  draw  up  a  written  declaration  of  conformity  for  each  product 
model and keep it at the disposal of the national authorities for 10 years after the product has 
been placed on the market. The declaration of conformity shall identify the product model for 
which it has been drawn up. 

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

6.  The  manufacturer  shall,  for  a  period  ending  at  least  10  years  after  the  product  has  been 
placed on the market, keep at the disposal of the national authorities: 

– 

– 

– 

the documentation referred to in point 3.1, 

the change referred to in point 3.5, as approved, 

the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4. 

7. Each notified body shall inform its notifying authorities of quality system approvals issued 
or  withdrawn,  and  shall,  periodically  or  upon  request,  make  available  to  its  notifying 
authorities the list of quality system approvals refused, suspended or otherwise restricted. 

Each notified body shall inform the other notified bodies of quality system approvals which it 
has refused, suspended or withdrawn, and, upon request, of quality system approvals which it 
has issued. 

8. Authorised representative 

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The  manufacturer's  obligations  set  out  in  points  3.1,  3.5,  5  and  6  may  be  fulfilled  by  his 
authorised  representative,  on  his  behalf  and  under  his  responsibility,  provided  that  they  are 
specified in the mandate. 

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(cid:208) 94/9/EC 

ANNEX VIII 

MODUL: INTERNAL CONTROL OF PRODUCTION 

1.  This  module  describes  the  procedure  whereby  the  manufacturer  or  his  authorized 
representative established within the Community, who carries out the obligations laid down in 
Section 2, ensures and declares that the equipment satisfies the requirements of the Directive 
applicable  to  it.  The  manufacturer  or  his  authorized  representative  established  within  the 
Community  shall  affix  the  CE  marking  to  each  piece  of  equipment  and  draw  up  a  written 
declaration of conformity. 

2. The manufacturer shall establish the technical documentation described in Section 3 and he 
or his authorized representative established within the Community shall keep it at the disposal 
of  the  relevant  national  authorities  for  inspection  purposes  for  a  period  ending  at  least  10 
years after the last piece of equipment was manufactured. 

Where  neither  the  manufacturer  nor  his  authorized  representative  is  established  within  the 
Community,  the  obligation  to  keep  the  technical  documentation  available  shall  be  the 
responsibility of the person who places the equipment on the Community market. 

3.  Technical  documentation  shall  enable  the  conformity  of  the  equipment  with  the  relevant 
requirements  of  the  Directive  to  be  assessed.  It  shall,  to  the  extent  necessary  for  such 
assessment, cover the design, manufacture and operation of the product. It shall contain: 

– 

– 

– 

– 

– 

– 

a general description of the equipment, 

conceptual  design  and  manufacturing  drawings  and  schemes  of  components,  sub-
assemblies, circuits, etc., 

descriptions and explanations necessary for the understanding of said drawings and 
schemes and the operation of the equipment, 

a  list  of  the  standards  applied  in  full  or  in  part,  and  descriptions  of  the  solutions 
adopted to meet the safety aspects of the Directive where the standards have not been 
applied, 

results of design calculations made, examinations carried out, etc., 

test reports. 

4. The manufacturer or his authorized representative shall keep a copy of the declaration of 
conformity with the technical documentation. 

5.  The  manufacturer  shall  take  all  measures  necessary  to  ensure  that  the  manufacturing 
process  guarantees  compliance  of 
technical 
documentation referred to in Section 2 and with the requirements of the Directive applicable 
to such equipment. 

the  manufactured  equipment  with 

the 

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MODULE: INTERNAL PRODUCTION CONTROL 

(cid:216) new 

1.  Internal  production  control  is  the  conformity  assessment  procedure  whereby  the 
manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares 
on  his  sole  responsibility  that  the  products  concerned  satisfy  the  requirements  of  this 
Directive that apply to them. 

2. Technical documentation 

The manufacturer shall establish the technical documentation. The documentation shall make 
it possible to assess the product's conformity to the relevant requirements, and shall include an 
adequate analysis and assessment of the risk(s). 

The  technical  documentation  shall  specify  the  applicable  requirements  and  cover,  as  far  as 
relevant  for  the  assessment,  the  design,  manufacture  and  operation  of  the  product.  The 
technical documentation shall contain at least the following elements: 

– 

– 

– 

– 

– 

– 

a general description of the product, 

conceptual  design  and  manufacturing  drawings  and  schemes  of  components,  sub-
assemblies, circuits, etc. 

descriptions and explanations necessary for the understanding of those drawings and 
schemes and the operation of the product, 

a  list  of  the  harmonised  standards  and/or  other  relevant  technical  specifications  the 
references  of  which  have  been  published  in  the  Official  Journal  of  the  European 
Union, applied in full or in part, and descriptions of the solutions adopted to meet the 
essential  health  and  safety  requirements  of  this  Directive  where  those  harmonised 
standards have not been applied. In the event of partly applied harmonised standards, 
the technical documentation shall specify the parts which have been applied, 

results of design calculations made, examinations carried out, etc., and 

test reports. 

3. Manufacturing 

The manufacturer shall take all measures necessary so that the manufacturing process and its 
monitoring ensure compliance of the manufactured products with the technical documentation 
referred to in point 2 and with the requirements of this Directive that apply to them. 

4. Conformity marking and declaration of conformity 

4.1. The manufacturer shall affix the required conformity markings set out in this Directive to 
each individual product that satisfies the applicable requirements of this Directive. 

4.2. The manufacturer shall draw up a written declaration of conformity for a product model 
and  keep  it  together  with  the  technical  documentation  at  the  disposal  of  the  national 

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authorities for 10  years  after the product has been  placed  on  the  market.  The  declaration  of 
conformity shall identify the product for which it has been drawn up. 

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

5. Authorised representative 

The  manufacturer's  obligations  set  out  in  point  4  may  be  fulfilled  by  his  authorised 
representative, on his behalf and under his responsibility, provided that they are specified in 
the mandate. 

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(cid:208) 94/9/EC 

ANNEX IX 

MODULE: UNIT VERIFICATION 

1. This module describes the procedure whereby the manufacturer ensures and declares that 
the equipment or protective system which has been issued with the certificate referred to in 
Section  2  conforms  to  the  requirements  of  the  Directive  which  are  applicable  to  it.  The 
manufacturer or his authorized representative in the Community shall affix the CE marking to 
the equipment or protective system and draw up a declaration of conformity. 

2. The notified body shall examine the individual equipment or protective system and carry 
out  the  appropriate  tests  as  set  out  in  the  relevant  standard(s)  referred  to  in  Article  5,  or 
equivalent tests, to ensure its conformity with the relevant requirements of the Directive. 

The notified body shall affix, or cause to be affixed, its identification number on the approved 
equipment or protective system and shall draw up a certificate of conformity concerning the 
tests carried out. 

3. The aim of the technical documentation is to enable conformity with the requirements of 
the Directive to be assessed and the design, manufacture and operation of the equipment or 
protective system to be understood. 

The documentation shall contain: 

– 

– 

– 

– 

– 

– 

a general description of the product; 

conceptual  design  and  manufacturing  drawings  and  layouts  of  components,  sub-
assemblies, circuits, etc.; 

descriptions and explanations necessary for the understanding of said drawings and 
layouts and the operation of the equipment or protective system; 

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  of  the 
Directive where the standards referred to in Article 5 have not been applied; 

results of design calculations made, examinations carried out, etc.; 

test reports. 

MODULE: CONFORMITY BASED ON UNIT VERIFICATION 

(cid:216) new 

1. Conformity based on unit verification is the conformity assessment procedure whereby the 
manufacturer fulfils the obligations laid down in points 2, 3 and 5, and ensures and declares 
on his sole responsibility that the product concerned, which has been subject to the provisions 
of point 4, is in conformity with the requirements of this Directive that apply to it. 

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2. Technical documentation 

The  manufacturer  shall  establish  the  technical  documentation  and  make  it  available  to  the 
notified  body  referred  to  in  point  4.  The  documentation  shall  make  it  possible  to  assess  the 
product's  conformity  with  the  relevant  requirements,  and  shall  include  an  adequate  analysis 
and  assessment  of  the  risk(s).  The  technical  documentation  shall  specify  the  applicable 
requirements  and  cover,  as  far  as  relevant  for  the  assessment,  the  design,  manufacture  and 
operation  of  the  product.  The  technical  documentation  shall  contain  at  least  the  following 
elements: 

– 

– 

– 

– 

– 

– 

a general description of the product, 

conceptual  design  and  manufacturing  drawings  and  schemes  of  components,  sub-
assemblies, circuits, etc., 

descriptions and explanations necessary for the understanding of those drawings and 
schemes and the operation of the product, 

a  list  of  the  harmonised  standards  and/or  other  relevant  technical  specifications  the 
references  of  which  have  been  published  in  the  Official  Journal  of  the  European 
Union, applied in full or in part, and descriptions of the solutions adopted to meet the 
essential  health  and  safety  requirements  of  this  Directive  where  those  harmonised 
standards have not been applied. In the event of partly applied harmonised standards, 
the technical documentation shall specify the parts which have been applied, 

results of design calculations made, examinations carried out, etc., and 

test reports. 

The  manufacturer  shall  keep  the  technical  documentation  at  the  disposal  of  the  relevant 
national authorities for 10 years after the product has been placed on the market. 

3. Manufacturing 

The manufacturer shall take all measures necessary so that the manufacturing process and its 
monitoring ensure conformity of the manufactured product with the applicable requirements 
of this Directive. 

4. Verification 

A  notified  body  chosen  by  the  manufacturer  shall  carry  out  appropriate  examinations  and 
tests,  set  out  in  the  relevant  harmonised  standards  and/or  technical  specifications,  or 
equivalent tests, to check the conformity of the  product  with  the  applicable  requirements  of 
this Directive, or have them carried out. In the absence of such a harmonised standard and/or 
technical specification the notified body concerned shall decide on the appropriate tests to be 
carried out. 

The  notified  body  shall  issue  a  certificate  of  conformity  in  respect  of  the  examinations  and 
tests carried out and shall affix its identification number to the approved product, or have it 
affixed under its responsibility. 

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The  manufacturer  shall  keep  the  certificates  of  conformity  at  the  disposal  of  the  national 
authorities for 10 years after the product has been placed on the market. 

5. Conformity marking and declaration of conformity 

5.1.  The  manufacturer  shall  affix  the  required  conformity markings set out in this Directive 
and,  under  the  responsibility  of  the  notified  body  referred  to  in  point  4,  the  latter's 
identification  number  to  each  product  that  satisfies  the  applicable  requirements  of  this 
Directive. 

5.2.  The  manufacturer  shall  draw  up  a  written  declaration  of  conformity  and  keep  it  at  the 
disposal  of  the  national  authorities  for  10  years  after  the  product  has  been  placed  on  the 
market. The declaration of conformity shall identify the product for which it has been drawn 
up. 

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

6. Authorised representative 

The  manufacturer's  obligations  set  out  in  points  2  and  5  may  be  fulfilled  by  his  authorised 
representative, on his behalf and under his responsibility, provided that they are specified in 
the mandate. 

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(cid:208) 94/9/EC (new) 

ANNEX X 

A. CE MARKING 

The CE conformity marking shall consist of the initials «CE» taking the following form: 

If the 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. 

This  minimum  dimension  may  be  waived  for  small-scale  equipment,  protective  systems  or 
devices referred to in Article 1 (2). 

B. CONTENT OF THE EC DECLARATION OF CONFORMITY 

The EC declaration of conformity must contain the following elements: 

– 

– 

– 

– 

the name or identification mark and the address of the manufacturer or his authorized 
representative established within the Community; 

a description of the equipment, protective system, or device referred to in Article 1 
(2); 

all  relevant  provisions  fulfilled  by  the  equipment,  protective  system,  or  device 
referred to in Article 1 (2); 

where appropriate, the name, identification number and address of the notified body 
and the number of the EC-type-examination certificate; 

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– 

– 

– 

– 

where appropriate, reference to the harmonized standards; 

where appropriate, the standards and technical specifications which have been used; 

where  appropriate,  references  to  other  Community  Directives  which  have  been 
applied; 

identification of the signatory who has been empowered to enter into commitments 
on behalf of the manufacturer or his authorized representative established within the 
Community. 

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ANNEX XI 

MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER STATES 
FOR THE NOTIFICATION OF BODIES 

1. The body, its director and the staff responsible for carrying out the verification tests shall 
not  be  the  designer,  manufacturer,  supplier  or  installer  of  equipment,  protective  systems,  or 
devices  referred  to  in  Article  1  (2)  which  they  inspect,  nor  the  authorized  representative  of 
any  of  these  parties.  They  shall  become  involved  neither  directly  nor  as  authorized 
representatives  in  the  design,  construction,  marketing  or  maintenance  of  the  equipment, 
protective systems or devices referred to in Article 1 (2) in question. This does not preclude 
the possibility of exchanges of technical information between the manufacturer and the body. 

2.  The  body  and  its  inspection  staff  shall  carry  out  the  verification  tests  with  the  highest 
degree of professional integrity and technical competence and shall be free from all pressures 
and inducements, particularly financial, which may influence their judgement or the results of 
the inspection, especially from persons or groups of persons with an interest in the result of 
verifications. 

3. The body shall have at its disposal the necessary staff and possess the necessary facilities to 
enable  it  to  perform  properly  the  administrative  and  technical  tasks  connected  with 
verification; it shall also have access to the equipment required for special verification. 

4. The staff responsible for inspection shall have: 

– 

– 

– 

sound technical and professional training; 

satisfactory  knowledge  of  the  requirements  of  the  tests  which  they  carry  out  and 
adequate experience of such tests; 

the ability to draw up the certificates, records and reports required to authenticate the 
performance of the tests. 

5.  The  impartiality  of  inspection  staff  shall  be  guaranteed.  Their  remuneration  shall  not 
depend on the number of tests carried out or on the results of such tests. 

6.  The  body  shall  take  out  liability  insurance  unless  its  liability  is  assumed  by  the  State  in 
accordance with national law or the Member State itself is directly responsible for the tests. 

7.  The  staff  of  the  body  shall  be  bound  to  observe  professional  secrecy  with  regard  to  all 
information  gained  in  carrying  out  its  tasks  (except  vis-à-vis  the  competent  administrative 
authorities  of  the  State  in  which  its  activities  are  carried  out)  under  this  Directive  or  any 
provision of national law giving effect to it. 

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(cid:207) 

ANNEX X 

Part A 

Repealed Directive with its successive amendment 
(referred to in Article 42) 

Directive 94/9/EC of the European Parliament and 
the Council 
(OJ L 100, 19.4.1994, p. 1) 

Regulation (EC) No 1882/2003 of the European 
Parliament and of the Council 
(OJ L 284, 31.10.2003, p. 1) 

Only Article 6(3) 

Part B 

Time-limits for transposition into national law and application  
(referred to in Article 41) 

Directive 

Time-limit for transposition 

Date of application 

94/9/EC 

1 September 1995 

1 March 1996 

_____________

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ANNEX XI 

CORRELATION TABLE 

Directive 94/9/EC 

This Directive 

Article 1 (1) 

Article 1 (2) 

Article 1 (3), except the fourth subparagraph of 
the definition of "Equipment groups and 
categories" 

– 

Article 1 (3), fourth subparagraph of the 
definition of "Equipment groups and 
categories" 

Article 1 (4) 

Article 2 

Article 3 

Article 4 

Article 1(1)(a) 

Article 1(1)(b) 

Article 2(1) to (9) 

Article 2(10) to (26) 

Article 16(6) 

Article 1(2) 

Article 3 

Article 4 

Article 5 

Article 5 (1), first subparagraph 

– 

Article 5 (1), second subparagraph 

Article 12(2) 

Article 5 (2) and (3) 

 – 

– 

– 

Article 6 

Article 7 

Article 8 (1) to (6) 

Article 8 (7) 

– 

– 

– 

EN 

Articles 6 to 11 

Article 12(1) 

– 

– 

Article 13(1) to (6) 

– 

Articles 14 and 15 

Article 16(1) to (5) 

Articles 17 to 39 

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– 

Articles 9 to 13 

Article 14(1) 

Article 40(1) 

– 

– 

Article 14(2) and (3) 

Article 40(2) and (3) 

Article 15(1) 

Article 15(2) 

– 

– 

– 

Article 16 

Annexes I to IX 

Annex X 

Annex XI 

– 

– 

Article 41(1) 

– 

Article 41(2) 

Article 42 

Article 43 

Article 44 

Annexes I to IX 

– 

– 

Annex X 

Annex XI 

EN 

97 

   EN