EN    EN  
 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) 
 EN 2   EN 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 aligni ng ten product directives to 
Decision No 768/2008/EC establishing a common framework for the marketing of products. 
Union (EU) harmonisation legislation ensuring th e 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 ec onomic 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 moveme nt of products. It sets out th e essential health and safety 
requirements that products must comply with in order to be made availa ble on the EU market. 
Manufacturers must demonstrate that a produc t has been designed and manufactured in 
compliance with the essential health and safe ty requirements and affix the CE marking.  
Experience with the implementation of Uni on 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 beco me more and more complex, as frequently 
several pieces of legislation apply simu ltaneously to one and the same product. 
Inconsistencies in these pieces of legisla tion make it increasingly difficult for economic 
operators and authorities to correctly interpret an d apply that legislation. 
To remedy these horizontal shortcomings in Union harmonisation legi slation 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 applicat ion 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 . EN 3   EN The NLF Regulation has introduced rules on accr editation (a tool for the evaluation of 
competence of conformity assessment bodies) and requirements for the organisation and performance of market surveillance and contro ls of products from third countries. Since 1 
January 2010 these rules apply di rectly in all Member States. 
The NLF Decision sets out a common framewor k for EU product harmonisation legislation. 
This framework consists of the provision s which are commonly used in EU product 
legislation (e.g. definitions, obligations of economic operators, notified bodies, safeguard 
mechanisms, etc). These common provisions ha ve been reinforced to ensure that the 
directives can be applied and enforced more ef fectively in practice. New elements, such as 
obligations on importers, have b een introduced, which are crucia l 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 D ecision contains the corresponding obligations for economic 
operators and notified bodies allowing market  surveillance authoriti es and authorities 
responsible for notified bodies to properly perform the tasks imposed on them by the NLF 
Regulation and to ensure an effective and cons istent enforcement of EU product legislation. 
However, unlike the NLF Regulation, the provis ions of the NLF Deci sion are not directly 
applicable. To ensure that a ll economic sectors subject to Union harmonisation legislation 
benefit from the improvements of the NLF, the provisions of the NLF D ecision need to be 
integrated into the ex isting product legislation. 
A survey after the adoption of the goods packag e in 2008 showed that a majority of Union 
harmonisation legislation on products  was due to be revised with in 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 Parlia ment, Council and Commission have committed 
themselves to use its provisions as much as po ssible in future legislation on products in order 
to further the utmost coheren ce of the regulatory framework. 
For a number of other Union harmonisation di rectives, including Directive 94/9/EC, no 
revision for sector-specific prob lems had been envisaged within  this timeframe. To ensure 
that the problems in relation to non-complian ce and notified bodies are nevertheless addressed 
in these sectors, and for the sake of consiste ncy of the overall regulatory environment on 
products, it was decided to align these directiv es 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 Act
1, which has stressed the need to restore 
consumer confidence in the quality of pr oducts on the market and the importance of 
reinforcing market surveillance. 
Furthermore it supports the Commission’s polic y 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. EN 4   EN 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 implementa tion of this Directive,  the notified body group, 
the administrative cooperation group as well as th e representatives of indu stry 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 quest ionnaires for economic operators, 
authorities, notified bodies and users and the Co mmission services received 300 replies. The 
results are published at http://ec.europa.eu/ente rprise/policies/single -market-goods/regulatory-
policies-common-rules-for-products/new -legislative-framework/index_en.htm . 
In addition to the general consultation a specif ic 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/enterpri se/policies/single-market- goods/files/new-legislative-
framework/smes_statistics_en.pdf . 
The consultation process revealed widespread su pport 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 pl aying 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 co ncerns were expressed 
on some obligations which are, however, indispen sable for increasing the efficiency of market 
surveillance. These measures will not entail si gnificant costs for indus try, and the benefits 
resulting from improved market surveill ance 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 Legislativ e Framework. In addition to the expertise 
collected and analysed in that context, furt her consultation of sect or-specific experts and 
interest groups, as well as horizontal expert s active in the area of technical harmonisation, 
conformity assessment, accreditation and market surveillance, has taken place. 
External expertise was used to obtain some basi c data on certain sectors:  for the ATEX sector, 
the study "Market description, comp etitiveness analysis in the fi eld of products and protective 
systems intended for use in potentially  explosive atmospheres", available on 
http://ec.europa.eu/enterprise /sectors/mechanical/files/atex /atexcomp_finalreport_en.pdf . 
Impact assessment  
Based on the information collected, the Commis sion 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 ex clusively on certain 
improvements that can be expected from the NLF Regulation. EN 5   EN Option 2 – Alignment to the NLF Deci sion by non-legislative measures 
Option 2 considers the possibility of encourag ing 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 Deci sion by legislative measures 
This option consists in integrating the provi sions 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 responsib ly, no extra costs or only neg ligible costs are expected; 
– it is considered more effective than option 2: du e to the lack of enforc eability of option 2 it 
is questionable that the positive impact s would materialise under that option; 
– options 1 and 2 do not provide an swers to the problem of inconsistencies in the regulatory 
framework and therefore have no positive impact on the simplification of the regulatory environment. 
3. M
AIN ELEMENTS OF THE PROPOSAL  
3.1. Horizontal definitions 
The proposal introduces harmonised definiti ons of terms which are commonly used 
throughout Union harmonisation le gislation and should therefor e be given a consistent 
meaning throughout that legislation. 
3.2. Obligations of economic operators  and traceability requirements 
The proposal clarifies the obliga tions of manufactur ers and authorised representatives and 
introduces obligations for impor ters and distributors. Importe rs must verify that the 
manufacturer has carried out the applicable c onformity assessment procedure and has drawn 
up a technical documentation. They must also ma ke sure with the manufacturer that this 
technical documentation can be made availa ble to authorities upon request. Furthermore 
importers must verify that the products are co rrectly 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 addre ss on the product, or where this is not possible 
on the packaging or the accompanying documenta tion. Distributors must verify that the 
product bears the CE marking, the name of the ma nufacturer 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 ha ve supplied non-compliant products. EN 6   EN Enhanced traceability obligations  are introduced for all econo mic operators. Products have 
to bear the manufacturer’s na me and address and a number allo wing 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. Furtherm ore every economic operato r must be able to 
identify towards authorities th e economic operator who has supp lied him with a product or to 
whom he has supplied a product. 
3.3. Harmonised standards 
Compliance with harmonised st andards provides a presumpti on 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 Regula tion 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 stakehol der participation in 
the standardisation process. C onsequently the provisions of Directive 94/9/EC which cover 
the same aspects have been deleted in th is proposal for reasons  of legal certainty. 
The provisions conferring presumption of conf ormity 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 dem onstrate that their products comply with the 
essential health and safety requirements. Th e 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 se t 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 crite ria for notified bodies. It clarifies that 
subsidiaries or subcontractors mu st also comply with the notification requirements. Specific 
requirements for notifying authorities are intro duced, and the procedure for notification of 
notified bodies is revised. The competence of a notified body mu st be demonstrated by an 
accreditation certificate. Where accred itation has not been used to evaluate the competence of 
a notified body, the notification must compri se the documentation demonstrating how the 
competence of that body has been ev aluated. 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 cl ause 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. EN 7   EN authorities concerned, when a non-compliant product is f ound. A real safeguard clause 
procedure – leading to a Decision at Commissi on 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 take n, all Member States 
must take the appropriate  action on their territory. 
3.7. Comitology and Delegated acts 
The provisions on the operation of standing comm ittees have to be adapted to the new rules 
on delegated acts laid down in Article 290 of th e 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 comm ittee. 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 a dopt implementing acts appears under the new 
Directive, therefore this provision has been deleted in the proposal. 
The Commission will set up an expert work ing group in accordance with the Communication 
from the President to the Commission - Framew ork for Commission expe rt 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 Tr eaty 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 particul ar with regard to th e newly added provisions 
aiming at the improvement of effective enfo rcement of Directive 94/9/EC, namely, the 
importer and distributor obligations, the tra ceability provisions, the provisions on the 
assessment and notification of notified bodies, and the enhanced  cooperation obligations in 
the context of the revised market su rveillance and safeguard procedures. 
Experience with the enforcement of the legislat ion has shown that meas ures 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 natio nal level is limited to the territorial competence of a 
Member State. In view of the increasing inte rnationalisation of trad e, 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 con cerning mechanisms for control by Member States 
of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p.13). EN 8   EN border cases is constantly rising. Coordinated ac tion at EU level can much better achieve the 
objectives set, and will in particular render ma rket surveillance more effective. Hence it is 
more appropriate to take  action at EU level. 
As regards the problem of inconsistencies thro ughout the directives, th is 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 impos e unnecessary burdens an d costs on industry - 
especially on small and medium sized enterpri ses - 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 th at entail added cost.  
Legislative technique used 
The alignment to the NLF Deci sion requires a number of subs tantive 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 th e Interinstitutional Agreement of 28 November 
2001 on a more structured use of th e recasting technique  for legal acts
4.  
The changes made to the provisions of Dire ctive 94/9/EC concern: the definitions, the 
obligations of economic operators, the presum ption 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 th e 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. EN 9   EN  
Ð 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 CO UNCIL 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 Eu ropean Economic and Social Committee
5, 
Acting in accordance with the or dinary legislative procedure, 
Whereas: 
 
Ø new 
(1) Directive 94/9/EC of the European Parl iament and the Council of 23 March 1994 on 
the approximation of the laws of the Me mber 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. 
(2) Regulation (EC) No 765/2008 of the European Parliament and of th e Council of 9 July 
2008 setting out the requirements for accredi tation and market surveillance relating to 
the marketing of products and re pealing Regulation (EEC) No 339/937 lays down rules 
on the accreditation of  conformity assessm ent bodies, provides a framework for the 
                                                 
5 OJ C […], [Date], p. […]. 
6 OJ L 100, 19.4.1994, p. 1. 
7 OJ L 218, 13.8.2008, p. 30. EN 10   EN market surveillance of products and for cont rols on products from third countries, and 
lays down the general princi ples of the CE marking. 
(3) Decision No 768/2008/EC of the European Pa rliament and of the Council of 9 July 
2008 on a common framework for the marketi ng 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. Dire ctive 94/9/EC should therefore be adapted to 
that Decision. 
 
Ð 94/9/EC recital 1 (adapted) 
(4) Whereas  iIt is the duty of Member States to pr otect, on their territo ry, the safety and 
health of persons and, where appropriate , domestic animals and property and, in 
particular, that of workers, especially ag ainst the hazards resulting from the use of 
equipment and systems providing prot ection against potentially explosive 
atmospheres; . 
 
Ð 94/9/EC recital 2 (adapted) 
Wher eas 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 ar e generally electrical and non -electrical specificatio ns having 
an effect on the design and struct ure of equipment which can be used in potentially explosive 
atmospheres;  
 
Ð 94/9/EC recital 3 (adapted) 
Whereas the requirements to be met by such equipment differ from one Member State to 
another i n respect of their extent and differi ng inspection procedures; whereas these 
differences are, therefore, likely to rais e barriers to trade within the Community;  
 
Ð 94/9/EC recital 4 (adapted) 
Whereas h armonization of nationa l legislation is t he only way in which to remove these 
barriers to free trad e; whereas t his objective cannot be satisfactorily achieved by the 
individual Member States ; whereas t his Directive merely lays down the requirements vital to 
freedom of movement for th e equipment t o which it applies;  
 
Ð 94/9/EC recital 5 (adapted) 
Whereas the regulations intended to remove tec hnical barriers to trade are required to follow 
the new approach provided for in the Council resolution of 7 May 19859, which requires a 
definiti on of the essential requirements regarding safety and other requirements of society 
without reducing existing, justifie d levels of protection within  the Member States; whereas 
                                                 
8 OJ L 218, 13.8.2008, p. 82. 
9 OJ No C 136, 4. 6. 1985, p. 1.  EN 11   EN that resolution provides that a very la rge number of products be covered by a si ngle Directive 
in order to avoid frequent amendments  and the proliferation of Directives;  
 
Ð 94/9/EC recitals 6 and 8 
(adapted) 
(5) Whereas  the existing  Directives  ⌦ 94/9/EC ⌫ on the approximation of the laws of 
the Me mber States to electrical equipment fo r use in potentially explosive atmosphere s 
have  ⌦ has ⌫ made positive steps towards ⌦ effective ⌫ protection against 
explosions via measures linked with the struc ture 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 g uard 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 po ssess considerable economic significance. 
 
Ð 94/9/EC recital 7 (adapted) 
Whereas the form taken by the hazard, the protec tive 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 sin gle Directive protective equipment and systems falling 
within both groups;  
 
Ð 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 safe ty 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 additiona l 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 pote ntially explosive atmosphere, is also 
necessary. 
 
Ð 94/9/EC recital 10 (adapted) 
Whereas the intention is to prepare a Dire ctive on operations in potentially explosive 
atmospheres which is based on Article 118a; wh ereas that additional Directive will, in 
particular, aim at explosion hazards which derive from a given use and/or types and methods 
of installation;  EN 12   EN  
Ð 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 j udgment 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 obtaini ng at the time of manufacture and 
overriding tech nical and econom ic requirements . 
 
Ð 94/9/EC recital 12 (adapted) 
Whereas, t herefore, this Directive sets out essent ial requirements on ly; whereas, in  order to 
facilitate the task of proving compliance w ith the essential requirements, harmonized 
European stan dards are necessary, more especi ally with regard to the non -electrical aspects of 
protection against explosions — standards relating to the de sign, manufacture and testing of 
equipment, compliance with which enables a product to be presumed to meet such essential 
requirements; whereas h armonized European standards are drawn up by private bodies and 
must retain their  non-mandatory status; whereas, f or this purpose, the European Committee 
for Standardization (CEN) and the European Committee for Electrotechnic al 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, f or the purposes of this  Directive, a harmonized 
standard is a technical specifi cation (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 19 83 providing for a procedure governing the 
provision of information on tec hnical standards and regulations10 and pursuant to the general 
guidelines referred  to above ; 
 
Ð 94/9/EC recital 13 (adapted) 
Whereas the legislative framework should be improved in order to ensu re that employers and 
workers make an effective and appropriate cont ribution towards the standardization process; 
whereas this should be completed by th e time this Directive is implemented;  
 
Ð 94/9/EC recital 14 (adapted) 
Whereas, i n view of the nature of the risks involved  in the use of equipment in potentially 
explosive atmospheres it is nece ssary to establish procedures applying to the assessment of 
compliance with the basic requirements of the  Directives ; whereas t hese procedures must be 
devised in the light of the level of risk whic h may be inherent in e quipment and/or against 
which systems must protect the immedia te environment; whereas, t herefore, each category of 
equipment conformity must be supplemented by an a dequate procedure or a choice between 
several  equivalent procedures; whereas t he procedures adopted co mply fully with Council 
Decision 93/465/EEC of 22 July 1993 concerning the modules for the va rious 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 13   EN conformity assessment procedures which ar e intended to be used in the technical 
harmonization Directives11; 
 
Ð 94/9/EC recital 15 (adapted) 
Whereas t he Council has provided for the affixing of th e CE marking by either the 
manufacturer or his authorized  representative within the Commu nity; whereas t hat marking 
means that the product complies with all the basic requirement s and assessment procedures 
provided for by the Community law applying to that product;  
 
Ð 94/9/EC recital 16 (adapted) 
Whereas i t is appropriate that th e 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 person s and, where appropriate, domestic anim als or property, provided that the 
measures are subject to a Community control procedure;  
 
Ð 94/9/EC recital 17 (adapted) 
Whereas t he recipients of any decision taken as  part of this Directive must be aw are of the 
reasons behind that decision and t he means of appeal open to them ; 
 
Ð 94/9/EC recital 18 (adapted) 
Whereas, on 18 December 1985, the Council adopted  a framework Direct ive on electrical 
equipment for use in potentially explosive atm ospheres (76/117/EEC)12 and, on 15 February 
1982, a Directive concerning el ectrical 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 t otal harmonization of th e optional and partial 
harmonization on which these Directives are ba sed had been contemplated; whereas this 
Directive fully covers the scope of the above mentioned Directives and whereas, therefore, 
these Directives must be repealed ; 
 
Ð 94/9/EC recital 19 (adapted) 
Whereas t he internal market incorporat es an area without internal  frontiers within which the 
free movement of goods, persons, se rvices and capital is assured;  
 
Ð 94/9/EC recital 20 (adapted) 
Whe reas it is necessary to provide for a tr ansitional arrangement enabling equipment 
manufactured in compliance with the national regul ations in force at the date of adoption of 
this Directive to be  marketed and placed in service;  
                                                 
11 OJ No L 220, 30. 8. 1993, p. 23.  
12 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).  
13 OJ No L 59, 2. 3. 1982, p. 10.  EN 14   EN  
Ø new 
(8) Economic operators should be responsible for the compliance of products, in relation 
to their respective role s in the supply chain, so as to ensure a high level of protection 
of public interests, such as health and safe ty, and the protection of end-users and of the 
environment, and to guarantee fair competition on the Union market. 
(9) All economic operators interv ening in the supply and di stribution 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 wh ich 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 c onformity assessment procedure. Conformity 
assessment should therefore remain the ob ligation of the manu facturer alone. 
(11) It is necessary to ensure th at products from third countri es entering the Union market 
comply with the requirements of this Direct ive, and in particul ar 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 shou ld 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 manuf acturers are available for inspection by 
the supervisory authorities. 
(12) The distributor makes a product available on th e market after it ha s been placed on the 
market by the manufacturer or the importer a nd should act with due care to ensure that 
its handling of the product doe s not adversely a ffect 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 a ffected 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 t hose 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 effi cient. An efficient traceability system EN 15   EN facilitates market surveillan ce authorities' task of tracing economic operators who 
made non-compliant products available on the market. 
(17) This Directive should be limited to the expr ession 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 Parliame nt and of the Council of […..] on European 
Standardisation and amending Council Di rectives 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 th e 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 de monstrate and the competent authorities to 
ensure that products made available on the ma rket conform to the essential health and 
safety requirements it is necessary to pr ovide 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 le vel of safety required. In or der to ensure inter-sectoral 
coherence and to avoid ad-hoc variants, c onformity assessment procedures should be 
chosen from among those modules. 
(20) The manufacturer should draw up an EU declar ation of conformity to provide detailed 
information on the conformity of a product w ith the requirements of this Directive. 
(21) The CE marking, indicating the conformity of  a product, is the vi sible consequence of 
a whole process comprising conformity assessment in a broad sense. General 
principles governing the CE marking ar e set out in Regulation (EC) No 765/2008. 
Rules governing the affixing of the CE marki ng should be laid down in this Directive. 
(22) The conformity assessment pro cedures 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 notif ied to the Commission are not sufficient to 
ensure a uniformly high level of performan ce of notified bodies th roughout the Union. 
It is, however, essential that all notified bodies perform their f unctions to the same 
level and under conditions of fair competiti on. That requires the setting of obligatory 
requirements for conformity assessment bodi es wishing to be notified in order to 
provide conformity assessment services. 
                                                 
14 OJ L […], [Date], p. […]. EN 16   EN (24) In order to ensure a consis tent level of quality in th e performance of conformity 
assessment it is also necessary to set re quirements for notifying authorities and other 
bodies involved in the asse ssment, notification and mon itoring of notified bodies. 
(25) If a conformity assessment body demonstrates conformity with the criteria laid down 
in harmonised standards, it should be presumed to co mply with the corresponding 
requirements set out in this Directive. 
(26) The system set out in this Directive s hould be complemented by the accreditation 
system provided for in Regulation (EC)  No 765/2008. Since ac creditation is an 
essential means of verifying the compet ence of conformity assessment bodies, it 
should also be used for th e purposes of notification. 
(27) Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring 
the necessary level of confidence in confor mity 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 author ities, they should 
provide the Commission and th e other Member States with the necessary documentary 
evidence demonstrating the compliance of th e conformity assessment bodies evaluated 
with the relevant regu latory requirements. 
(28) Conformity assessment bodies frequently subcon tract parts of their activities linked to 
the assessment of conformity or have recour se 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 relati on to the performa nce of conformity 
assessment tasks. Therefore, it is important  that the assessment of the competence and 
the performance of bodies to be notified and the monitori ng of bodies already notified 
cover also activities carried out by subcontractors and subsidiaries. 
(29) It is necessary to increase the efficiency a nd transparency of the notification procedure 
and, in particular, to adapt it to new technol ogies 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 Co mmission 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 co mpetence of conformity assessment bodies 
can be clarified before they start operating as notified bodies. 
(31) In the interests of compe titiveness, it is crucial that  notified bodies apply the 
conformity assessment procedures without  creating unnecessary burdens for economic 
operators. For the same reason, and to ensu re equal treatment of  economic operators, 
consistency in the technical application of the conformity assessment procedures must 
be ensured. That can best be achiev ed through appropriate coordination and 
cooperation between notified bodies. 
(32) In order to ensure legal certainty, it is neces sary to clarify that rules on Union market 
surveillance and control of products ente ring the Union market provided for in 
Regulation (EC) No 765/2008 apply to produc ts covered by this Directive. This EN 17   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 safe guard 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 effi cient and drawing on 
the expertise available in Member States. 
(34) The existing system should be supplement ed by a procedure under which interested 
parties are informed of measures intende d 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 surveillanc e authorities, in cooperation 
with the relevant economic ope rators, to act at an earlie r 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 furt her involvement of the Commission should 
be required, except where non-compliance ca n 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 th is 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 produc ts that have already been placed on the 
market in accordance wi th Directive 94/9/EC. 
(38) Since the objective of this Directive, name ly 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 gua ranteeing 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 princi ple 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 in to national law should be  confined to those 
provisions which represent a substantive chan ge 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 18   EN  
Ð 94/9/EC 
HAVE ADOPTED THIS DIRECTIVE: 
CHAPTER  I1 
 
Ð 94/9/EC (adapted) 
SCOPE , PLACING ON THE MARK ET AND FREEDOM OF MO VEMENT  ⌦ GENERAL 
PROVISIONS  ⌫ 
Article 1 
⌦ Scope ⌫ 
1. This Directive a pplies  ⌦ shall apply ⌫ to ⌦ the following products: ⌫ 
 
Ð 94/9/EC 
(a) equipment and protective systems intended fo r use in potentially explosive atmospheres. ; 
 
Ð 94/9/EC (adapted) 
(b) 2. S safety devices, controlling devices and regul ating devices intended for use outside 
potentially explosive atmosphere s but required for or contribu ting 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 ⌫ : 
 
Ð 94/9/EC 
– medical devices intended for us e in a medical environment; 
– equipment and protective systems where th e explosion hazard re sults exclusively 
from the presence of explosive substan ces or unstable chemical substances; 
– equipment intended for use in domestic and non-commercial environments where 
potentially explosive atmospheres may only rare ly be created, solely as a result of the 
accidental leakage of fuel gas; 
– personal protective equipment covered by Council  Directive 89/686/EEC15; 
                                                 
15 OJ L 399, 30.12. 1989, p. 18. EN 19   EN – seagoing vessels and mobile offshore units together with equipment on board such 
vessels or units; 
– means of transport, i.e. vehicles and thei r trailers intended solely for transporting 
passengers by air or by road, rail or water ne tworks, as well as means of transport in 
so far as such means are designed for tran sporting goods by air, by public road or rail 
networks or by water. Vehicles inte nded for use in a pot entially explosive 
atmosphere shall not be excluded; 
– the equipment covered by Article 223 346(1)(b) of the Treaty. 
 
Ð 94/9/EC (adapted) 
Article 2  
⌦ Definitions ⌫ 
3.For the purposes of this Directive, the following definitions shall  apply: 
Equipment and protective syst ems intended for use in poten tially explosive atmospheres  
 
Ð 94/9/EC 
Î1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 
(1) (a) 'Eequipment' means machines, apparatus, fixe d or mobile devices, control components 
and instrumentation thereof and detection or pr evention systems which, separately or jointly, 
are intended for the generation, tr ansfer, storage, measurement, Î1 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. ; 
 
Ð 94/9/EC 
Î1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 
Ö new 
(2) (b) Î1 'Pprotective systems' means devices other than components of the equipment 
defined above which are intended to halt incipien t explosions immediately and/or to limit the 
effective range of an explosion and which are separately placed  Ö made available  on the 
market for use as autonomous systems.   ; 
 
Ð 94/9/EC (adapted) 
(3) (c)'Ccomponents' means any item essential to the safe functioning of equipment and 
protective systems but with no autonomous function. ; 
Explosive atmospheres  EN 20   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  
 
Ð 94/9/EC (adapted) 
Î1 Corrigendum, OJ L 304, 
5.12.2000, p. 19 
(6) 'Eequipment group I'  applies  ⌦ means ⌫ equipment intended for use Î1 in 
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; ⌫ 
 
Ð 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 definitio n of the required levels of protection, as 
referred to ⌫ The categories of equipment defini ng the required levels of protection  are 
described  in Annex I. ; 
Equipment and protective systems may be designe d 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; ⌫ 
 
Ø new 
[Article R1 of Decision No 768/2008/EC] 
(10) 'making available on the market' mean s any supply of a product for distribution, 
consumption or use on the Union market in th e course of a commercial activity, whether in 
return for payment or free of charge; 
(11) 'placing on the market' means the firs t making available of a product on the Union 
market; EN 21   EN (12) 'manufacturer' means any natural or lega l 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 natura l or legal person established within the Union 
who has received a written mandate from a manuf acturer to act on his be half in relation to 
specified tasks; 
(14) 'importer' means any natural or legal pe rson established within the Union who places a 
product from a third count ry on the Union market; 
(15) 'distributor' means any natural or lega l person in the supply chain, other than the 
manufacturer or the importer, who ma kes a product available on the market; 
(16) 'economic operators' means the manufacturer , the authorised repres entative, the importer 
and the distributor; 
(17) 'technical specification' means a document that prescribes techni cal requirements to be 
fulfilled by a product, process or service; 
(18) 'harmonised standard' means harmonised st andard as defined in Article 2(1)(c) of 
Regulation (EU) No [../..] [on European Standardisation]; 
(19) 'accreditation' means accreditation as define d in Article 2(10) of  Regulation (EC) No 
765/2008; 
(20) 'national accreditation body'  means accreditation body as de fined in Article 2(11) of 
Regulation (EC) No 765/2008; 
(21) 'conformity assessment' means the proces s demonstrating whether the essential health 
and safety requirements relating to a product, pro cess, service or system have been fulfilled; 
(22) 'conformity assessment body' means a body that performs conformity assessment 
activities including calib ration, testing, certification and inspection; 
(23) 'recall' means any measure aimed at achie ving the return of a pr oduct 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 ma nufacturer indicates th at the product is in 
conformity with the applicable requirements  set out in Union harmonisation legislation 
providing for its affixing; 
(26) 'Union harmonisation legislation' m eans any Union legislation harmonising the 
conditions for the marketing of products. EN 22   EN  
Ð 94/9/EC (adapted) 
Ö new 
Article 2 3 
⌦ 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  Ö made available  on the market and put into service only 
if, when properly installed a nd maintained and used for  ⌦ in accordance with ⌫ their 
intended purpose, they do not endanger the health and sa fety 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 part icular, workers are protected when using the 
equipment, protective systems, and devices refe rred 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 syst ems, 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 th ey have been brought into conformity by 
the manufacturer or his authorized repr esentative established in the Community  ⌦ Union ⌫ 
. During demonstrations, adequate safety measures  shall be taken to ensure the protection of 
persons. 
 
Ð 94/9/EC (adapted) 
Article 3 4 
⌦ 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 23   EN  
Ð 94/9/EC (adapted) 
Î1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 
Ö new 
Article 4 5 
⌦ Free movement ⌫ 
1. Member States shall not prohibit, restrict or impede the placing  Ö making available  on 
the market and putting into service in their te rritory 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  Ö making available  on 
the market of components which, Î1 accompanied by a written atte station 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. 
 
Ð 94/9/EC 
Articl e 5 
1. Member States shall regard as conforming to all the provisions of this Directive, including 
the relevant conformity assessment pr ocedures laid down in chapter II:  
– equipment, protective systems, and devices referred to in Article 1 (2) accompanied 
by the EC declaration o f 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, Membe r States shall take any steps which they deem 
necessary to bring to the attention of the pa rties concerned the exis ting national technical 
standards and specifications regarded as important  or relevant to the proper implementation of 
the essential health a nd safety requirements in Annex II.  
2. Where a national standard tr ansposing a harmonized standar d, 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 requir ements, the equipment, protective system, device referred 
to in Article 1 (2), or the component referred to in Article 4 (2), c onstructed in accordance 
with that standard shall be presumed to comply  with the relevant essential health and safety 
requirement s. 
Member States shall publish the references of national standards transposing harmonized 
standards.  EN 24   EN 3. Member States shall ensure th at appropriate measures are taken to enable the social 
partners to influence the process of preparing and monitoring the h armonized standards at 
national level.  
Article 6  
1. Where a Member State or the Commission cons iders that the harmonized standards referred 
to in Article 5 (2) do not entirely satisfy the rele vant essential health and safety requirements 
referred to in Art icle 3, the Commission or the Member State concerned shall bring the matter 
before the Committee set up under  Directive 83/189/EEC, hereinaf ter referred to as «the 
Committee'», giving reasons therefor. The Committ ee shall deliver an opinion without delay.  
Upon receipt of the Committee's opinion, the Co mmission 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 measu re with a view to en suring the practical 
application in a uniform manner of this Direc tive in accordance with the procedure laid down 
in paragraph 3.  
 
Ð Regulation (EC) No 1882/2003 
3. The Commission shall be assisted by a standing committee (hereinafter referr ed to as 'the 
Committee'.  
Where reference is made to this paragr aph, Articles 3 and 7 of Decision 1999/486/EC16 shall 
apply, having regard to the pr ovisions of Article 8 thereof.  
The Committee shall adopt its rules of procedure.  
 
Ð 94/9/EC 
4. The Standing Committee may furthermore exam ine 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.  
Article 7  
 
Ð 94/9/EC 
1. When a Member State ascertain s 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 th e safety of persons and, where appropr iate, domestic 
animals or prope rty, i t shall take all appropriate measure s to withdraw such equipment or 
protective systems from the mark et, 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 25   EN The Member State shall immediately inform th e Commission of any such measure, indicating 
the reasons for its decision and, in particular, whether non -conformity is due to:  
(a) failure to satisfy the essential requirements referred to in Article 3;  
(b) incor rect application of the standards referred to in Article 5 (2);  
(c) shortcomings in the standards referred to in Article 5 (2).  
2. The Commission shall enter into consultatio n with the parties concerned without delay. 
Where the Commission considers, after this consultation, that the m easure is justified, it shall 
immediately so inform the Member State wh ich took the initiative and the other Member 
States. Where the Commission considers, after this  consultation, that the action is unjustified, 
it shall immed iately 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 
Membe r State at the origin of the decision ma intains its position, the Commission shall 
immediately inform the Committee in order to in itiate the procedures referred to in Article 6 
(1). 
3. Where equipment, a protective system or  a device referred to in Article  1(2) whic h does not 
comply bears the CE conformity marking, the co mpetent Member State sh all take appropriate 
action against the person(s) having affixed th e marking and shall so inform the Commission 
and the other Member States.  
4. The Commission shall e nsure that the Member States are kept informed of the progress and 
outcome of this procedure.  
 
Ø 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, manuf acturers shall ensure th at they have been 
designed and manufactured in accordance with th e essential health and safety requirements 
set out in Annex II. 
2. Manufacturers shall draw up th e technical documentation referre d to in Annex II and carry 
out the relevant conformity assessment procedure referred to in Article 13 or have it carried 
out. EN 26   EN Where compliance of a product with the applicab le requirements has been demonstrated by 
that procedure, manufacturers shall draw up an EU  declaration of confor mity and affix the CE 
marking and the specific mark ing 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 pl aced on the market. 
4. Manufacturers shall ensure that procedures ar e in place for series production to remain in 
conformity. Changes in a product design or ch aracteristics and changes in the harmonised 
standards or in technical spec ifications by reference to whic h conformity of a product is 
declared shall be adequately taken into account. 
5. Manufacturers shall ensure that  their products bear a type, ba tch or serial number or other 
element allowing their identifica tion, or, where the size or na ture 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 whic h the manufacturer can be 
contacted. 
7. Manufacturers shall ensure th at the product is accompanied by instructions and safety 
information in a language which can be easily u nderstood 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 w ith 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 prod uct presents a risk, manufacturers shall 
immediately inform the competent national author ities of the Member States in which they 
made the product available to th at 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 compet ent national authority, 
provide it with all the information and do cumentation necessary to demonstrate the 
conformity of the product, in a language wh ich 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 author ised representative's mandate. EN 27   EN 2. An authorised representative shall perform the tasks specified in the mandate received from 
the manufacturer. The mandate shall allow the au thorised representative to do at least the 
following: 
(a) keep the EU declaration of conformity  and the technical documentation at the 
disposal of national surveill ance authorities for at least 10 years after the product has 
been placed on the market; 
(b) further to a reasoned request from a co mpetent national authority, provide that 
authority with all the information and doc umentation necessary to demonstrate the 
conformity of a product; 
(c) cooperate with the competent national au thorities, 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] 
Obligations of importers 
1. Importers shall place only compliant products on the Union market. 
2. Before placing a product on the market impor ters shall ensure th at the appropriate 
conformity assessment procedure has been carried out by the manufacturer. They shall ensure 
that the manufacturer has drawn up the techni cal documentation, that the product bears the 
CE marking and the specific marking of e xplosion protection and is accompanied by the 
required documents, and that the manufacturer ha s complied with the requirements set out in 
Article 6(5) and (6). 
Where an importer considers or has reason to belie ve that a product is not in conformity with 
the essential health and safety requirements se t out in Annex II, he sh all 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 th e manufacturer and the market surveillance 
authorities to that effect. 
3. Importers shall indicate thei r name and the address at whic h 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 u nderstood by end-users, as determined by the 
Member State concerned. 
5. Importers shall ensure that, while a prod uct 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 pro duct which they have placed on 
the market is not in conformity with the requir ements of this Directive shall immediately take 
the corrective measures necessary to bring th at product into conform ity, to withdraw it or EN 28   EN recall it, if appropriate. Furthermore, where the product presents a risk, importers shall 
immediately inform the competent national author ities of the Member States in which they 
made the product available to th at 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 availa ble to those authorities, upon 
request. 
8. Importers shall, further to a reasoned request  from a competent nati onal authority, provide 
it with all the information and documentation n ecessary to demonstrate the conformity of a 
product in a language which can be easily unders tood by that authority. They shall cooperate 
with that authority, at its re quest, on any action taken to elim inate 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 th e CE marking and the specific ma rking 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 manufact urer and the importer have complied with the 
requirements set out in Article 6(5) and (6) a nd Article 8(3). 
Where a distributor considers or has reason to be lieve 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 distri butor shall inform the manufact urer or the importer to that 
effect as well as the market surveillance authorities. 
3. Distributors shall ensure that , while a product is under thei r 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 necessa ry 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 immediat ely inform the competent nationa l authorities of the Member 
States in which they made the product available to that effect, giving de tails, 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 do cumentation necessary to demonstrate the EN 29   EN conformity of a product. They sh all 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 manufac turers apply to impor ters and distributors 
An importer or distributor shall be consider ed a manufacturer for the purposes of this 
Directive and he shall be subjec t to the obligations of the ma nufacturer under Article 6, where 
he places a product on the market under his name or trademark or modifi es a product already 
placed on the market in such a way that complia nce 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) any economic operator who has s upplied them with a product; 
(b) any economic operator to whom they have supplied a product. 
Economic operators shall be able to present the information refe rred to in the first paragraph 
for a period of 10 years after th ey have been supplied with th e 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 conform ity 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 essen tial health and safety re quirements covered by 
those standards or parts ther eof, 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 30   EN  
Ð 94/9/EC (adapted) 
2. In the absence of harmoniz sed standards, Member States shall take any steps which they 
deem necessary to bring to th e attention of the parties con cerned to the existing national 
technical standards and specifi cations regarded as importan t or relevant to the proper 
implementation of the essential health and safety requirements ⌦ set out ⌫ in Annex II. 
 
Ð 94/9/EC (adapted) 
Ö new 
Article 8 13 
⌦ 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 auth orized representative est ablished in the Community must, in 
order to affix the CE marking, follow the  CE type -examination  Ö EU-type 
examination  procedure ( referred to in Annex III) , in conjunction with ⌦ either of 
the following procedures ⌫ : 
– the procedure relating to production quality assurance  Ö Conformity to type 
based on quality assurance of the production process  (referred to in Annex 
IV),; or 
– the procedure relating to product verification  Ö 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) iI n the case of internal combustion engine s 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  Ö EU-type examination  procedure ( referred to in 
Annex III) , in conjunction with ⌦ either of the following procedures ⌫ : 
– the procedure relating to conformity to type  Ö Conformity to type based 
on internal production control pl us supervised product testing  referred 
to in Annex VI; or  
– the procedure relating to product quality assurance  Ö Conformity to type 
based on product quality assurance  referred to in Annex VII; 
(ii) in the case of other equipment in th ese groups and categories, the manufacturer 
or his authorized representative establis hed in the Community must, in order to 
affix the CE mark, follow  the procedure relating to  internal control of 
production  Ö Internal production control  (referred to in Annex VIII)  EN 31   EN and 
the communication of the dossier provi ded for in Annex VIII, paragraph 3 2, to a 
notified body, which shall acknowledge recei pt of it as soon as possible and 
shall retain it. 
(c) ⌦ for ⌫ equipment-group II, equipment-cat egory 3 The manufacturer or his 
authorized representative established in the  Community must, in order to affix the 
CE marking, follow , the procedure relating to in ternal control of production  
Ö Internal production control  referred to i n Annex VIII; 
(d) ⌦ for ⌫ equipment-groups I and II,  iIn addition to the proce dures 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  
Ö 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 assessm ent of autonomous protective systems. 
 
Ð 94/9/EC (adapted) 
Î1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 
Ö new 
3. The procedures referred to in paragraph 1 sh all 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. Î1 A 
written attestation Ö of conformity  shall be issued by the manufacturer  or his 
authorized representative established in the Community  ⌦ Union ⌫, declaring the 
conformity of the component s 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 ⌫ . 
 
Ð 94/9/EC (adapted) 
Ö new 
4. In addition, the manufacturer or his aut horized 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 rela ting to internal control of production  Ö Internal 
production control  referred to in Annex VIII ⌦ may be followed ⌫ . 
5. Notwiths tanding 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 th e Member State concerned of the equipment, 
protective systems and i ndividual 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. EN 32   EN 6. Documents and correspondence relating to  the procedures referred to in the 
abovementioned  paragraphs ⌦ 1 to 4 ⌫ shall be drawn up in one of the o fficial languages 
of the Member States in whic h those procedures are being a pplied or in a language accepted 
by the notified body  ⌦ a language easily understood by end-users, as determined by the 
Member State concerned ⌫ . 
 
Ð 94/9/EC 
7. 
(a) Where the equipment, protective systems a nd devices referred to in Article 1(2) ar e 
subject to other Community Directives cove ring other aspects which also provide for 
the affixing of the CE marking referred to in Article 10, tha t marking shall indicate 
that the equipment, protective systems and devices referred to in Article 1(2) ar e also 
presumed to conform with the provisions of those other Directives.  
(b) However, where one or more of those Directives allow the manufacturer, d uring a 
transitional period, to choose which arrange ments to apply, the CE marking shall 
indicate conformity only with the Directiv es 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 documen ts, notices or instructions 
required by the Directives an d accompanying the equipment, protective systems and 
devices referred to in Article 1(2).   
 
Ø new 
Article 14 [Article R10 of Decision No 768/2008/EC] 
EU declaration of conformity 
1. The EU declaration of conformity shall state th at the fulfilment of the essential health and 
safety requirements set out in Annex II has been demonstrated. 
2. The EU declaration of confor mity shall have the model structure set out in Annex III of 
Decision No 768/2008/EC, shall contain the elemen ts specified in the relevant conformity 
assessment procedures set out in Annexes III to IX of this Directive a nd 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 on e Union act requiring an EU declaration of 
conformity, a single EU declarat ion of conformity shall be dr awn up in respec t of all such 
Union acts. That declaration sh all contain the identification of the acts concerned, including 
the publication references. 
4. By drawing up the EU declarat ion of conformity, the manufact urer shall assume the full 
responsibility for the co mpliance of the product. EN 33   EN 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 ma rking and the specific marking of explosion 
protection 
1. The CE marking shall be affixe d visibly, legibly and indelibly to the product or to its data 
plate. Where that is not possible or not warra nted 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 th e product is placed on the market. It shall be 
accompanied by the specific marking of explosion protection 
 , followed by the symbol of 
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 num ber of the notified body, where th at body is involved in the 
production control phase. 
The identification number of the notified body sh all 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 th e symbol referred to in paragraph 2 and, 
where applicable, the identification number re ferred to in paragraph 3, may be followed by a 
pictogram or any other mark indi cating 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.  
 
Ð 94/9/EC (adapted) 
Equipment and protective systems  may be  ⌦ Products that are ⌫ designed for a particular 
explosive atmosphere. In this case, they must  ⌦ shall ⌫ be marked accordingly. EN 34   EN  
Ø 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 th e 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 sha ll be responsible for setting up 
and carrying out the necessary procedures for the assessment and notific ation of conformity 
assessment bodies and the monitoring of notif ied bodies, including compliance with the 
provisions of Article 23. 
2. Member States may decide that the assessmen t and monitoring referred to in paragraph 1 
shall be carried out by a nationa l accreditation body within the m eaning of and in accordance 
with Regulation (EC) No 765/2008. 
3. Where the notifying authority delegates or ot herwise 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 res ponsibility 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 or ganised and operated so as to  safeguard the objectivity and 
impartiality of its activities. EN 35   EN 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 prov ide any activities that conformity assessment 
bodies perform or consultancy services on a commercial or competitive basis. 
5. A notifying authority shall safeguard the conf identiality of the information it obtains. 
6. A notifying authority shall have a sufficient nu mber 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 proce dures 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 conform ity assessment body shall meet the requirements 
laid down in paragraphs 2 to 11. 
2. A conformity assessment body shall be es tablished under national law and have legal 
personality. 
3. A conformity assessment body shall be a th ird-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, manufactur ing, provision, assembly, use or maintenance 
of products which it assesses, may, on condition that its independence an d 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 assess ment tasks shall not be the de signer, manufacturer, supplier, 
installer, purchaser, owner, user  or maintainer of the products which they assess, nor the 
authorised representative of any of those par ties. 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 ma nagement and the personnel responsible for 
carrying out the conformity assessment tasks sh all not be directly involved in the design, EN 36   EN manufacture or construction, th e marketing, installation, us e or maintenance of those 
products, or represent the partie s engaged in those activities. They shall not engage in any 
activity that may conflic t with their independence of judgeme nt or integrity in relation to 
conformity assessment activities for which they are notified. This shall in particular apply to 
consultancy services. 
Conformity assessment bodies sh all ensure that the activitie s 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 cap able 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 assessm ent 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) personnel with technical knowledge and suffi cient and appropriate  experience to 
perform the conformity assessment tasks; 
(b) descriptions of procedures in accordan ce with which conformity assessment is 
carried out, ensuring the transparency and the ability of reproduction of those 
procedures. It shall have appr opriate policies and procedures  in place that distinguish 
between tasks it carries out as a notified body and other activities; 
(c) procedures for the performan ce of activities which take due  account of the size of an 
undertaking, the sector in which it operates, its structure, the degr ee of complexity of 
the product technology in question and the ma ss 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 co nformity assessment activ ities shall have the 
following: 
(a) sound technical and vocational training c overing all the conformity assessment 
activities in relation to wh ich the conformity assessmen t body has been notified; 
(b) satisfactory knowledge of the requirements of the assessments they carry out and 
adequate authority to ca rry out those assessments; EN 37   EN (c) appropriate knowledge and understanding of  the essential health and safety 
requirements set out in Annex II, of the a pplicable harmonised standards and of the 
relevant provisions of Union harmonisation legislation and of na tional legislation; 
(d) the ability to draw up certificates, records and reports demonstrating that assessments 
have been carried out. 
8. The impartiality of the conformity assessm ent 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 sh all take out liability  insurance unless lia bility 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 profe ssional secrecy with 
regard to all information obtained in carrying out their tasks under Anne xes III to IX or any 
provision of national law giving effect to it, exce pt in relation to the competent authorities of 
the Member State in which its act ivities are carried out. Proprieta ry rights shall be protected. 
11. Conformity assessment bodies shall partic ipate in, or ensure that their assessment 
personnel are informed of, the relevant standa rdisation activities and the activities of the 
notified body coordination group establishe d under the relevant Union harmonisation 
legislation and apply as ge neral guidance the administra tive 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 fa r as the applicable harm onised 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 subcontract s specific tasks connected with  conformity assessment or 
has recourse to a subsidiary, it shall ensure that the subcontract or or the subsidiary meets the 
requirements set out in Article 21 and sha ll inform the notifying authority accordingly. 
2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or 
subsidiaries wherever these are established. EN 38   EN 3. Activities may be subcontracted or carried ou t by a subsidiary only with the agreement of 
the client. 
4. Notified bodies shall keep at th e disposal of the notifying au thority 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 confor mity assessment module or modules and the product or products for 
which that body claims to be competent, as we ll as by an accreditation certificate, where one 
exists, issued by a national accr editation body attesting that the conformity assessment body 
fulfils the requirements laid down in Article 21. 
3. Where the conformity assessment body c oncerned cannot provide an accreditation 
certificate, it shall provide the notifying aut hority with all the documentary evidence 
necessary for the verification, recognition and re gular 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 no tify 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 product s concerned and the 
relevant attestation of competence. 
4. Where a notification is not based on an accredita tion certificate as refe rred to in Article 24, 
the notifying authority shall provide the Co mmission and the other Member States with 
documentary evidence which attests to the c onformity assessment body's competence and the 
arrangements in place to ensure  that that body will be monitore d 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 onl y where no objections 
are raised by the Commission or the other Memb er States within two weeks of a notification 
where an accreditation certificate is used or within two mont hs of a notification where 
accreditation is not used. EN 39   EN Only such a body shall be considered a notifie d body for the purposes of this Directive. 
6. The Commission and the other Member States sh all 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 iden tification number to a notified body. 
It shall assign a single such number even wh ere the body is notified under several Union acts. 
2. The Commission shall make publicly availabl e 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 ha s ascertained or has been informed that a notified body no 
longer meets the requirements laid down in Artic le 21, or that it is  failing to fulfil its 
obligations, the notifying authority shall rest rict, suspend or with draw 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 restri ction, suspension or withdrawal of notification, or where the notified 
body has ceased its activity, the notifying Member State shall take appropr iate steps to ensure 
that the files of that body are ei ther processed by another notif ied body or kept available for 
the responsible notifying and market survei llance 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 requirem ents and responsibilities to which it is subject. 
2. The notifying Member State shall provide th e Commission, on request, with all information 
relating to the basis for the no tification or the maintenance of the competence of the body 
concerned. EN 40   EN 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 notif ied body does not meet or no longer meets the 
requirements for its notification, it shall info rm the notifying Member State accordingly and 
request it to take the necessary corrective meas ures, 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 acco rdance with the conformity 
assessment procedures provide d for in Annexes III to IX. 
2. Conformity assessments sh all be carried out in a pr oportionate manner, avoiding 
unnecessary burdens for economic operators. C onformity assessment bodies shall perform 
their activities taking due account of the size of an undertaking, the sector in which it 
operates, its structure, the degr ee 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 th e degree of rigour and the level of protection 
required for the compliance of the product w ith 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 specifica tions 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 comp lies with the requirement s laid down in this 
Directive, it shall require the manufacturer to take appropriat e 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 withdr aw any certificates, as appropriate. 
Article 30 
Appeal against decision s of notified bodies 
Member States shall ensure that an appeal pr ocedure against decision of the notified bodies is 
available. EN 41   EN 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) any refusal, restriction, suspension or withdrawal of a certificate; 
(b) any circumstances affecting the scope of and conditions for notification; 
(c) any request for information which they have received from market surveillance 
authorities regarding confor mity assessment activities; 
(d) on request, conformity assessment activitie s performed within the scope of their 
notification and any other ac tivity performed, including cr oss-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 organisa tion 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 coope ration between bodies 
notified under this Directive are put in place an d 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. EN 42   EN 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 Regula tion (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 suffici ent 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 co rrective action to bring 
the product into compliance with those require ments, to withdraw the product from the 
market, or to recall it within a reasonable peri od, commensurate with the nature of the risk, as 
they may prescribe. 
The market surveillance author ities shall inform the relevant notified body accordingly. 
Article 21 of Regulation (EC) No 765/2008 shall ap ply to the measures referred to in the 
second subparagraph. 
2. Where the market surveillance authorities consid er that non-compliance is not restricted to 
their national territory, they shall inform the Commission and the other Me mber States of the 
results of the evaluation and of the actions wh ich they have required the economic operator to 
take. 
3. The economic operator shall ensure that all ap propriate corrective acti on is taken in respect 
of all the products concerned that it has ma de available on the market throughout the Union. 
4. Where the relevant economic op erator does not take adequate  corrective action within the 
period referred to in the second subparagrap h of paragraph 1, the market surveillance 
authorities shall take all appropriate provisiona l measures to prohibit or restrict the being 
made available on their national market, to withdraw  the product from that market or to recall 
it. EN 43   EN 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 id entification of the non-compliant  product, the or igin of the 
product, the nature of the non-compliance alle ged 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 surv eillance authorities sha ll indicate whether the 
non-compliance is due to any of the following: 
(a) failure of the product to meet requirements re lating to the health or safety of persons 
or to other aspects of public interest protection laid down in  this Directive; 
(b) shortcomings in the harmonised standard s referred to in Annex II conferring a 
presumption of conformity. 
6. Member States other than the Member Stat e initiating the procedure shall without delay 
inform the Commission and the other Member St ates 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 notifie d 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 re strictive 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 le gislation, the Commission shall without delay 
enter into consultation with the Member St ates and the relevant  economic operator or 
operators and shall evaluate th e 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 it s decision to all Member States and shall immediately 
communicate it to them and the releva nt economic operator or operators. 
2. If the national measure is cons idered justified, all Member St ates 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 nati onal measure is considered unjustified, the 
Member State concerned shall withdraw the measure. 
3. Where the national measure is considered justified and the non-co mpliance of the product 
is attributed to shortcomings in the harmonised st andards referred to in Article 35(5)(b) of this EN 44   EN Directive, the Commission shall apply the proce dure provided for in Ar ticle 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 Dir ective, it presents a risk to the health or 
safety of persons or to other aspects of public in terest protection laid down in this Directive, it 
shall require the relevant economic operator to ta ke 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 w ithin 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 avai lable 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 deta ils, in particular the data necessary for the 
identification of the product c oncerned, the origin and the suppl y 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 an d shall evaluate the national measures taken. 
On the basis of the results of that evalua tion, the Commission sha ll 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 releva nt 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) 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; 
(b) the CE marking or the specific explosion protection marking has not been affixed; 
(c) the EU declaration of conformity has not been drawn up; 
(d) the EU declaration of conformity  has not been drawn up correctly; EN 45   EN (e) technical documentation is either  not available or not complete. 
2. Where the non-compliance referred to in paragr aph 1 persists, the Member State concerned 
shall take all appropriate measures to restrict  or prohibit the product be ing made available on 
the market or ensure that it is reca lled or withdrawn from the market. 
 
Ð 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 ca rry out the procedures referred to in Article 8, together with 
the specific tasks which these bodie s have been appointed to carry ou t 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 thei r identification numbers and the tasks for which they h ave been 
notified. The Commission shall ensure that this list is kept up to date.  
2. Member States shall apply the criteria laid do wn in Annex XI in asse ssing the bodies to be 
indicated in such notification. Bodies meeting the assessmen t 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 notificat ion if it finds that 
the body no longer meets the criteria referre d to in Annex XI. It shall immediatel y inform the 
Commission and the other Me mber States accordingly.  
CHAPTER  III 
CE CONFORMITY MARKING  
Article 10  
1. The CE conformity marking shal l 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 i nvolved in the production control stage.  
2. The CE marking shall be affixed d istinctly, visibl y, legibly and i ndelibly to equipment, 
protective systems and devices referred to i n Article 1(2 ), supplementary to the provisions of 
point 1.0.5. of Annex II.  
3. The affixing o f markings on the equipment, protective systems or devices referred to in 
Article 1(2 ) which are likely to deceive third partie s as to the meaning and form of the  CE 
marking shall be prohibited. Any other marking may be aff ixed to t he 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.  EN 46   EN Article 11  
Without prejudic e to Article 7:  
(a) where a Member State establishes that the CE marking has been incorrectly affixed, 
the manufacturer or his authorized represen tative established within the Community 
shall be obliged t o bring the product into conformit y as regards the p rovisions 
concerning the CE marking and to end the infringement under the conditions 
imposed by the Member State;  
(b) 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 withdr awn from the market in  accordance with the 
procedures laid down in Article 7.  
CHAPTER  IV6 
 
Ð 94/9/EC (adapted)  
⌦ TRANSITIONAL AND  ⌫ FINAL PROVISIONS  
 
Ð 94/9/EC 
Article 12  
Any decision taken pursuant to this Directive which restricts or prohi bits 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 devic e 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 info rmed 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 confiden tiality in respect of all information  obtained in the performance of 
carrying out their tasks. This doe s not affect the obligations of the Member States and of the 
notified bodies regarding reci procal information and the dissemination of warnings.  EN 47   EN  
Ø new 
Article 39 
Penalties 
Member States shall lay down rules on penaltie s 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 eff ective, 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 dela y of any subsequent 
amendment affecting them. 
 
Ð 94/9/EC (adapted) 
Ö new 
Article 14 40 
⌦ Transitional provisions ⌫ 
1. Directive 76/117/EEC, Directive 79/196/EEC17 and Directive 82/130/EEC shall be repealed 
as from 1 July 2003.  
Ö 1. Member States shall not impede the maki ng 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 [t he date set out in the second subparagraph of 
Article 41(1)].  
2. EC  Certificates of conformity to the harmoni sed 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 Directive s. 
3. Member States shall take the necessary action  ⌦ measures ⌫ to ensure that the notified 
bodies which are responsible pursu ant 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  Ö [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).  EN 48   EN  
Ð 94/9/EC (adapted) 
Ö new 
Article 15 41 
⌦ Transposition ⌫ 
1. Member States shall adopt and publish ⌦ by ⌫ Ö [insert date: 2 y ears after adoption]  
⌦ at the latest ⌫ the laws, regulations and administra tive provisions nece ssary to comply 
with this Directive  ⌦ Article 2(2) and (10) to (26), Article 3, Artic les 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 a nd 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 me ntioned 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 offici al 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 ⌫ . 
 
Ð 94/9/EC 
2. However, Member States shall allow the plac ing on the market and the putting into service 
of equipment and protective systems conforming w ith the national regulations in force in their 
territory at the date of a doption of this Directive for the period until 30 June 2003.  
 
Ø new 
2. Member States shall communicate to the Co mmission the text of the main provisions of 
national law which they adopt in th e field covered by this Directive. 
 
Ð  
Article 42 
Repeal 
Directive 94/9/EC, as amended by the Regulation lis ted in Annex X, Part A, is repealed with 
effect from [the date set out in the second subparagraph of Arti cle 41(1)], without prejudice to EN 49   EN the obligations of the Member States relating to the time-limits for transposition into national 
law and application of th e 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 tw entieth 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 A nnexes I, II, X and XI 
shall apply from [the date set out in the second subparagraph of Article 41(1)]. 
 
Ð 94/9/EC (adapted) 
Article 16 44 
⌦ Addresses ⌫ 
This Directive is addressed to the Member States. 
Done at […], 
For the European Parliament For the Council  
The President The President  EN 50   EN  
Ð 94/9/EC 
ANNEX I  
CRITERIA DETERMINING THE CLASSI FICATION 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 establishe d by the manufacturer and ensuring a very 
high level of protection. 
 Equipment in this category is intended for use in underg round 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 th e 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 comp ly with the supplementary requirements 
referred to in Annex II, 2.0.1. 
(b) Category M 2 comprises equipment desi gned to be capable of functioning in 
conformity with the operational paramete rs established by the manufacturer and 
ensuring a high level of protection. 
 Equipment in this category is intended for use in underg round parts of mines as well 
as those parts of surface in stallations of such mines likely to be endangered by 
firedamp and/or combustible dust. 
 This equipment is intended to be de-e nergized in the event of an explosive 
atmosphere. 
 The means of protection rela ting 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 partic ular those arising from rough handling and changing 
environmental conditions. 
 Equipment in this category must comp ly with the supplementary requirements 
referred to in Annex II, 2.0.2. EN 51   EN 2. EQUIPMENT -GROUP II 
(a) Category 1 comprises equipment designed to  be capable of functioning in conformity 
with the operational parameters establishe d by the manufacturer and ensuring a very 
high level of protection. 
 Equipment in this category is intende d 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 th e requisite level of pr otection, even in the 
event of rare incidents relating to equipm ent, 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 th e 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 comp ly 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. 
 
Ð 94/9/EC 
Î1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 
 Equipment in this category is intende d for use in areas in which explosive 
atmospheres caused by gases, vapo urs, mists or air/dust mixtures Î1 are likely to 
occur occasionally.  
 
Ð 94/9/EC 
 The means of protection rela ting to equipment in this cat egory 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 comp ly 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 intende d for use in areas in which explosive 
atmospheres caused by gases, vapours, mist s, or air/dust mixtures are unlikely to EN 52   EN 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 comp ly with the supplementary requirements 
referred to in Annex II, 2.3. 
 
Ð 94/9/EC 
ANNEX II  
ESSENTIAL HEALTH AND SAFETY RE QUIREMENTS RELATING TO THE 
DESIGN AND CONSTRUCTION OF EQ UIPMENT AND PROTECTIVE SYSTEMS 
INTENDED FOR USE IN POTENTIA LLY EXPLOSIVE ATMOSPHERES 
Preliminary observations 
A. Technological knowledge, which can change rapi dly, must be taken into account as far as 
possible and be uti lized immediately. 
 
Ð 94/9/EC (adapted) 
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 respec t to the risks of explosion. 
 
Ð 94/9/EC 
1. COMMON REQUIREMENTS FOR EQUI PMENT AND PROTECTIVE SYSTEMS 
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 manuf acturer 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 atmos pheres, taking into account the nature of 
every electrical and non-ele ctrical source of ignition, 
– should an explosion neverthele ss occur which could direct ly 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 flam es and explosion pre ssures to a sufficient 
level of safety. EN 53   EN 1.0.2. Equipment and protective systems must be designed and manufactured after due 
analysis of possible operating faults in order as far as po ssible to preclude dangerous 
situations. 
Any misuse which can reasonably be antic ipated must be taken into account. 
1.0.3. Special checking and ma intenance conditions 
Equipment and protective system s subject to special checki ng and maintenance conditions 
must be designed and constructe d 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 foreseeab le 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, 
 
Ð 94/9/EC (adapted) 
– CE marking (see Annex X, point A  ⌦ II to Regulation (EC) No 765/2008 ⌫ ), 
 
Ð 94/9/EC 
– designation of series or type, 
– serial number, if any, 
– year of construction, 
– the specific marking of explosion protection 
  followed by the symbol of the 
equipment group and category, 
– for equipment-group II, the letter 'G' (conc erning explosive atmospheres caused by 
gases, vapours or mists), 
 and/or  the letter 'D' (concerning explosiv e 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 accompanie d by instructions, 
including at least the following particulars: EN 54   EN – a recapitulation of the information w ith which the equipment or protective 
system is marked, except for the seri al number (see 1.0.5.), together with any 
appropriate additional information to f acilitate 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 ta ken 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, ma ximum 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 characteri stics of tools which may be fitted to 
the equipment or protective system. 
 
Ð 94/9/EC (adapted) 
(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 ⌫ . 
 On being put into service, all equi pment and protective systems must be 
accompanied by a translation of the instructi ons 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 eith er 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 55   EN  By way of derogation from this requirement,  the maintenance instructions for use by 
the specialist personnel employed by the manufacturer or his authorized 
representative established in the Community  ⌦ Union ⌫ may be drawn up in a 
single Community  ⌦ Union ⌫ language understood by that personnel. 
 
Ð 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 pr otective system, together with all useful 
instructions, in particular with regard to safety. 
(d) Literature describing the equipment or pr otective system must not contradict the 
instructions with rega rd 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 wh ich could impair explosion protection. 
 
Ð 94/9/EC 
Î1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 
1.1.3. Materials must be so selected  that predictable ch anges in their charac teristics and their 
compatibility in combination with other material s 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, Î1 electrical conductivity, mechani cal strength, ageing resistance  and the 
effects of temperature variations. 
 
Ð 94/9/EC 
1.2. Design and Construction 
1.2.1. Equipment and protective systems must be de signed and constructed with due regard to 
technological knowledge of expl osion 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 th ey 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 gase s or dusts must wherever possible employ 
enclosed structures only. EN 56   EN  
Ð 94/9/EC 
Î1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 
If equipment contains openings or non-tight join ts, these must as far as possible be designed 
in Î1 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 Î1 so as to limit releases  of flammable materials  during filling or draining. 
 
Ð 94/9/EC 
1.2.4. Dust deposits  
Equipment and protective systems which are inte nded to be used in areas exposed to dust 
must be so designed that deposit dus t on their surfaces is not ignited. 
In general, dust deposits must be limited wh ere 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 ap propriate, 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 e xposed to certain types of external stresses 
must be equipped, where necessary, w ith 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 hous ing 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 a ppropriate protection measures. 
1.2.7. Protection against other hazards  
Equipment and protective systems must be  so designed and manufactured as to: 
(a) avoid physical injury or other harm which might be cau sed by direct or indirect 
contact; 
(b) assure that surface temperatures of accessi ble parts or radiation which would cause a 
danger, are not produced; 
(c) eliminate non-electrical dangers  which are revealed by experience; EN 57   EN  
Ð 94/9/EC 
Î1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 
(d) assure that Î1 foreseeable conditions of overload do not give rise  to dangerous 
situations. 
 
Ð 94/9/EC (adapted) 
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 appl y in the case of such equipment and protective systems and of 
such risks upon application of  those specific Directives. 
 
Ð 94/9/EC 
1.2.8. Overloading of equipment  
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 atmosphe re are placed in an enclosure, measures must 
be taken to ensure that the en closure withstands the pressure  developed during an internal 
explosion of an explosive mixture and preven ts the transmission of the explosion to the 
explosive atmosphere su rrounding 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, electromagneti c 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 58   EN 1.3.4. Hazards arising from overheating  
Overheating caused by friction or impacts occu rring, for example, between materials and 
parts in contact with eac h other while rotating or through th e intrusion of foreign bodies must, 
as far as possible, be prevented at the design stage. 
1.3.5. Hazards arising from pre ssure compensation operations  
Equipment and protective systems must be so designed or fitted with integrated measuring, 
control and regulation devices th at pressure compensations aris ing 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 f unction 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 appropriat e to the intended mechanical and thermal 
stresses and capable of withst anding attack by existing or foreseeable aggressive substances. 
1.5. Requirements in respect of safety-related devices 
 
Ð 94/9/EC 
Î1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 
1.5.1. Safety devices must function Î1 independently of any measurement and/or control 
devices  required for operation. 
As far as possible, failure of a safety devi ce must be detected sufficiently rapidly by 
appropriate technical means to en sure that there is only very  little likelihood that dangerous 
situations will occur. 
Î1 The fail-safe principle  is to be applied in general. 
 
Ð 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 ope ration only after the restart 
lockouts have been intentionally reset. EN 59   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 le vel 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 c onstructed so that they can c ope with foreseeable operating 
requirements and special conditions of use. 
1.5.6. Where necessary, it must be possible to ch eck the reading accuracy and serviceability 
of devices with a measuring function. 
1.5.7. The design of devices with a measuring func tion must incorporate a safety factor which 
ensures that the alarm threshold lies far enough out side the explosion and/ or ignition limits of 
the atmospheres to be registered, taking into ac count, in particular, the operating conditions of 
the installation and possible aberra tions 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 ar ising 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 proces ses 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 elect rochemically-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 fitt ed with suitable cable  and conduit entries. 
When equipment and protective systems are in tended for use in combination with other 
equipment and protective systems,  the interface must be safe. EN 60   EN 1.6.5. Placing of warning devices as parts of equipment  
Where equipment or protective systems are f itted with detection or alarm devices for 
monitoring the occurrence of explosive atmosphe res, the necessary instructions must be 
provided to enable them to be pr ovided 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 cons tructed 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 failu re of one means of protecti on, at least an independent 
second means provides the requi site level of protection, 
– or, the requisite level of protection is ensu red 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 dus t can penetrate it. 
2.0.1.3. The surface temperatures of equipment parts must be kept clearl y 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 th e opening of equipment parts which may be 
sources of ignition is possible only under non-active or intrinsica lly safe conditions. Where it 
is not possible to render equipment non-active, th e 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 equipp ed with means of protectio n ensuring that sources of 
ignition do not become active during normal operation, even under more severe operating conditions, in particular those arising fr om 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 th e opening of equipment parts which may be 
sources of ignition is possible only under non-acti ve conditions or via a ppropriate interlocking EN 61   EN systems. Where it is not possible to render eq uipment non-active, the manufacturer must affix 
a warning label to the opening part of the equipment. 
2.0.2.3. The requirements regarding explosion h azards arising from dust applicable to 
category M 1 must be applied. 
2.1. Requirements applicable to equipment in category 1 of equipment-group II 
 
Ð 94/9/EC 
Î1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 
2.1.1. Î1 Explosive atmospheres caused by gases, vapours or mists   
 
Ð 94/9/EC 
2.1.1.1. Equipment must be so designed and cons tructed that sources of ignition do not 
become active, even in event of ra re incidents relating to equipment. 
It must be equipped with m eans of protection such that: 
– either, in the event of failu re of one means of protecti on, at least an independent 
second means provides the requi site level of protection, 
– or, the requisite level of protection is ensu red 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 ar e not exceeded even in the most unfavourable 
circumstances. 
Temperature rises caused by heat build-ups and ch emical reactions must also be taken into 
account. 
2.1.1.3. Equipment must be so designed that th e opening of equipment parts which might be 
sources of ignition is possible only under non-active or intrinsica lly safe conditions. Where it 
is not possible to render equipment non-active, th e 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 caus ed by air/dust mixtures  
2.1.2.1. Equipment must be so desi gned and constructed that igni tion of air/dust mixtures 
does not occur even in the event of ra re incidents relating to equipment. 
It must be equipped with m eans of protection such that 
– either, in the event of failu re of one means of protecti on, at least an independent 
second means provides the requi site level of protection, EN 62   EN – or, the requisite level of protection is ensu red in the event of two faults occurring 
independently of each other. 
2.1.2.2. Where necessary, equipment must be so de signed 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 pa rts 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 e quipment 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 dist urbances or equipment operating faults, which 
normally have to be taken into account. 
2.2.1.2. Equipment parts must be so designed a nd constructed that th eir stated surface 
temperatures are not exceeded, even in the cas e of risks arising from abnormal situations 
anticipated by the manufacturer. 
2.2.1.3. Equipment must be so designed that th e opening of equipment parts which might be 
sources of ignition is possible only under non-acti ve conditions or via a ppropriate interlocking 
systems. Where it is not possible to render eq uipment non-active, the manufacturer must affix 
a warning label to the opening part of the equipment. 
2.2.2. Explosive atmospheres caus ed by air/dust mixtures  
2.2.2.1. Equipment must be designed and constructe d 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 temper atures, requirement 2.1.2.3 applies. 
2.2.2.3. With regard to protection agai nst dust, requirement 2.1.2.2 applies. 
2.2.2.4. With regard to the safe opening of e quipment 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 constr ucted 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 adopt s special additional protective measures. EN 63   EN 2.3.2. Explosive atmospheres caus ed by air/dust mixtures  
2.3.2.1. Equipment must be so designed and cons tructed 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 temper atures, requirement 2.1.2.3 applies. 
2.3.2.3. Equipment, including cable entries and c onnecting pieces, must be so constructed 
that, taking into account the size of its particle s, dust can neither deve lop 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 su ch a way as to reduce  the effects of an 
explosion to a suffici ent level of safety. 
 
Ð 94/9/EC 
Î1 Corrigendum, OJ L 21, 
26.1.2000, p. 42 
3.0.2. Protective systems mu st be designed and Î1 capable of being positioned in such a 
way  that explosions are preven ted from spreading through da ngerous chain reactions or 
flashover and incipient explosions  do not become detonations. 
 
Ð 94/9/EC 
3.0.3. In the event of a power failure, protective systems must retain th eir capacity to function 
for a period sufficient to a void a dangerous situation. 
3.0.4. Protective systems must not fail  due to outside interference. 
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 th e planning stage are the expected  pressure during an explosion 
occurring under extreme operating conditions and th e 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 syst ems must be capable of withstanding the 
expected maximum explosion pressure w ithout losing their capacity to function. 
3.1.4. The reactions caused by pressure in peri pheral equipment and connected pipe-work 
must be taken into consideration in the planning and design of protective systems. EN 64   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 pre ssure-relief devices whic h do not endanger persons 
in the vicinity. 
3.1.6. Explosion suppression systems 
 
Ð 94/9/EC 
Î1 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 th e event of an incident and counteract it Î1 to best 
effect, with due regard to  the maximum rate of pressure increase and the maximum 
explosion pressure. 
 
Ð 94/9/EC 
3.1.7. Explosion decoupling systems  
Decoupling systems intended to disconnect specifi c equipment as swiftly as possible in the 
event of incipient explosions by means of appr opriate 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 circ uit with a suitable 
alarm threshold so that, if necessary, there is cessation of product feed and output and 
shutdown of equipment parts whic h can no longer function safely. 
 
Ð 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 spec imen representative of the productio n envisaged meets the relevant 
applicable provision s 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:  
– 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 applicatio n has not been lodged with any other 
notified body;  EN 65   EN – the technical documentation, as described in point 3.  
The applicant shall place at the disposal of th e notified body a specimen representative of the 
production envisaged and he reinafter called «type». Th e notified body may request further 
specimens if needed for carry ing out the test programme.  
3. The technical documentation shall enable the conformity of the product with the 
requirements of the Directive to be assess ed. It shall, to the extent necessary for such 
assessment, cover the design, manufacture and operation of the produc t and shall to that 
extent contain:  
– a general type -description;  
– design and manufacturing drawings and layouts of components, sub -assemblies, 
circuits, etc.;  
– descriptions and expl anations necessary for the unders tanding 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 solu tions adopted to meet the essential requiremen ts 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 docu mentation, 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 st andards referred to in Article  5, 
as well as the components which have been de signed 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 manufactur er 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, wher e the manufacturer has chosen to apply the 
relevant s tandards;  
4.4. agree with the applicant the location where th e 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 66   EN A list of the significant part s 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 i s denied a 
type certification, th e notified body shall provide detail ed reasons for such denial.  
Provision shall be made fo r an appeals procedure.  
6. The applicant shall inform the notified body which holds the te chnical documentation 
concerning the  EC -type-examination c ertificate of all modifications to the approved 
equipment or protective system which must receive further ap prova l where suc h changes may 
affect conformit y 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 not ified body shall communicate to the other not ified bodies the relevant information 
concerning th e EC -type-examination c ertificates and addition s issued and withdrawn.  
8. The other notified bodies may receive copies of the  EC-type-examination c ertificates 
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 th e Community s hall keep 
with the technical documentation copies of  EC -type-examination ce rtificates 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 authori zed representative is established within the 
Community, th e obligation to keep the technical documentation available shall be the 
responsibility of the person who places the product on t he Community market.  
 
Ø new 
MODULE: EU-TYPE EXAMINATION 
1. EU-type examination is the pa rt of a conformity assessment  procedure in which a notified 
body examines the technical design of a product and verifies and attest s that the technical 
design of the product meets th e requirements of this Di rective that apply to it. 
2. EU-type examination shall be carried out with the examination of a specimen, 
representative of the produc tion envisaged, of the complete product (production type). 
3. The manufacturer shall lodge an application for EU-type exam ination with a single notified 
body of his choice. 
The application shall include: 
– the name and address of the manufacturer and, if the application is lodged by the 
authorised representative, hi s name and address as well, 
– a written declaration that the same applic ation has not been lodged with any other 
notified body, EN 67   EN – the technical documentation. The technical documentation shall make it possible to 
assess the product's conformity with the ap plicable requirements of this Directive 
and shall include an adequate analysis and assessment of the risk(s). The technical 
documentation shall specify the applicable requ irements and cover, as far as relevant 
for the assessment, the design, manufact ure and operation of the product. The 
technical documentation shall contai n at least the following elements: 
– a general description of the product, 
– conceptual design and manufacturing dr awings and schemes of components, 
sub-assemblies, circuits, etc., 
– descriptions and explanations nece ssary for the understanding of those 
drawings and schemes and the operation of the product, 
– a list of the harmonised sta ndards 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, an d descriptions of the solutions 
adopted to meet the essen tial health and safety requi rements of this Directive 
where those harmonised standards have not been applied. In the event of partly 
applied harmonised standards, the tec hnical 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 pr oduction 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 a nd/or technical specifications have not 
been applied in full. The supporting eviden ce shall include, where necessary, the 
results of tests carried out by the appropriate laboratory of the manufacturer, or by 
another testing laboratory on his be half and under his responsibility. 
4. The notified body shall: 
4.1. verify that the specimen(s) have been manu factured in conformity with the technical 
documentation, and identify the elements which have been designed in accordance with the 
applicable provisions of the rele vant 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 appl y 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 st andards and/or technica l specifications have EN 68   EN not been applied, the solutions  adopted by the manufacturer m eet the corresponding essential 
health and safety requirements of this Directive; 
4.4. agree with the manufacturer on a location where the examin ations and tests will be 
carried out. 
5. The notified body shall draw up an evaluation report that records the activities un dertaken 
in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à vis 
the notifying authorities, the notified body shall rel ease the content of that report, in full or in 
part, only with the agreem ent 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 sh all contain the name and addr ess of the manufacturer, the 
conclusions of the examination, the conditions (i f 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 a nnexes shall contain all relevant information to allow the conformity 
of manufactured products with th e 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 examinati on 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 th e product with the essential health and safety requirements of 
this Directive or the conditions for validity of the certificate. Such modi fications shall require 
additional approval in the form of an addition to  the original EU-type examination certificate. 
8. Each notified body shall inform its no tifying authorities concerning the EU-type 
examination certificates and/or any additions thereto which it has issued or withdrawn, and 
shall, periodically or upon re quest, make available to its no tifying authorities the list of 
certificates and/or any additi ons thereto refused, suspende d or otherwise restricted. 
Each notified body shall inform the other notif ied bodies concerning the EU-type examination 
certificates and/or any additi ons thereto which it has refu sed, withdrawn, suspended or 
otherwise restricted, and, upon re quest, concerning the certificat es and/or additions thereto 
which it has issued. 
The Commission, the Member States and the ot her notified bodies may, on request, obtain a 
copy of the EU-type examinati on certificates and/or additions thereto. On request, the 
Commission and the Member St ates may obtain a copy of the technical documentation and 
the results of the examinations carried out by  the notified body. The not ified body shall keep a 
copy of the EU-type examination certificate, it s annexes and additions, as well as the EN 69   EN technical file including the documentation subm itted 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 tec hnical documentation at the dispos al of the national authorities 
for 10 years after the product has been placed on the market. 
10. The manufacturer's authorised  representative may lodge th e application referred to in 
point 3 and fulfil the obligations set out in point s 7 and 9, provided that they are specified in 
the mandate. 
 
Ð 94/9/EC 
ANNEX IV  
MODULE: PRODUCTION  QUALITY ASSURANCE  
1. This module describes the procedure whereb y the manufacturer who satisfies the 
obligations of point 2 ensures and declares that the products concerned are in conformity w ith 
the type as described in the EC -type-examination c ertificate and satisfy the requirements of 
the Directive which apply to th em. The manufacturer, or  his authorized r epresentative 
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 responsib le for EC monitori ng, as specified in 
Section 4.  
2. The manufacturer shal l operate an approved quality syst em for production, final equipment 
inspection and testing as specified in Secti on 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 a pproved type and a copy of the EC -type-
examination certificate.  
3.2. The quality system shall ensure complia nce of the equipment with the type as described 
in the EC -type-examination certificate and with the re quirements of the Directive which apply 
to them.  
All the elements, requirements and provisi ons adopted by the ma nufacturer shall be 
documented in a systematic and orderly manner in the form of  written policies, procedures EN 70   EN and instructions. The quality system documentati on must permit a consistent interpretation of 
quality programmes, plans, manuals and records.  
It shall contain, in particular , an adequate description of  
– the quality objectives a nd 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 repor ts and test data, ca libration data, reports 
on the qualifications of the personnel conc erned, 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 syst em to determine whether it satisfies the 
requirements referred to in Section 3.2. It shall presume confor mity 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 evalua tion in the equipment 
technology conc erned. 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 examin ation and the reasoned assessment decision.  
3.4. The manufacturer shall undertake to fulfil the ob ligations arising out of  the quality system 
as approved and to uphold the system so that it remains adequate and efficient.  
The manufacturer or his au thorized represen tative shall inform the notified body  which has 
approved the quality system of any in tended updating of th e quality system.  
The notified body shall evaluate the modificatio ns 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 TH E 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 th e approved quality system.  
4.2. The manufacturer shall, for inspection pu rposes, allow the notified body access to the 
manufacture, inspect ion, testing and storage premises a nd shall provide it with all necessary 
information, in particular  
– the quality system documentation  EN 71   EN – the quality records , such as inspection reports and test dat a, calibration data, reports 
on the qualifications of the pers onnel concerned, etc.  
4.3. The notified body shall periodi cally carry out audits to en sure that the manufacturer 
maintains and applies the quality system and sh all provide an audit report to the manufacturer.  
4.4. Furthermore, the notified body may pay une xpected visits to the manufacturer. During 
such visits, the notified body may carry out tests, or arrange fo r 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 documentatio n referred to in the second indent of Section 3.1;  
– the updating referred to in the s econd paragraph of Section 3.4;  
– the decisions and reports from the notifie d body which are referred to in Section 3.4, 
last paragraph, Section 4.3 and Secton 4.4.  
6. Each n otified body shall appr ise the other notified bodies of the relevant information 
concerning the quality system a pprovals issued and withdrawn.  
 
Ø new 
MODULE: CONFORMITY TO  TYPE BASED ON QUAL ITY ASSURANCE OF THE 
PRODUCTION PROCESS 
1. Conformity to type based on quality assuran ce of the production process is the part of a 
conformity assessment procedure whereby the ma nufacturer fulfils the obligations laid down 
in points 2 and 5, and ensures and declares on his sole responsibil ity that the products 
concerned are in conformity w ith 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 opera te an approved quality syst em for production, final product 
inspection and testing of the produc ts concerned as specified in poi nt 3, and shall be subject to 
surveillance as specified in point 4. 
3. Quality system 
3.1. The manufacturer shall lodge an application fo r 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, hi s name and address as well, EN 72   EN – a written declaration that the same applic ation 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 appr oved 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 certificat e and comply with the requirements of this 
Directive that apply to them. 
All the elements, requirements and provisi ons adopted by the ma nufacturer shall be 
documented in a systematic and orderly manner in the form of written policies, procedures 
and instructions. The quality system documentati on shall permit a consistent interpretation of 
the quality programmes, plans, manuals and records. 
It shall, in particular, contai n an adequate description of: 
– the quality objectives and the organisational structure, responsibi lities and powers of 
the management with regard to product quality, 
– the corresponding manufacturi ng, quality control and qua lity 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 pe rsonnel 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 syst em to determine whether it satisfies the 
requirements referred to in point 3.2. 
It shall presume conformity with those requireme nts in respect of the elements of the quality 
system that comply with th e corresponding specifica tions of the national standard that 
implements the relevant harmonised sta ndard 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 releva nt product field and product 
technology concerned, and knowledge of the appli cable 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 i ndent, to verify the 
manufacturer's ability to identify the relevant re quirements of this Directive and to carry out 
the necessary examinations with a view to ensuring compliance of the product with those 
requirements. EN 73   EN The decision shall be notified to the manuf acturer. The notification shall contain the 
conclusions of the audit and th e reasoned assessment decision. 
3.4. The manufacturer shall undertake to fulfil the ob ligations arising out of  the quality system 
as approved and to maintain it so th at 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 requ irements 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 respons ibility of the notified body 
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the 
obligations arising out of th e approved quality system. 
4.2. The manufacturer shall, for assessment pur poses, allow the notified body access to the 
manufacture, inspection, testi ng and storage sites and shall pr ovide 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 aud its 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 repo rt and, if tests have been carr ied out, with a test report. 
5. Conformity marking and declaration of conformity 
5.1. The manufacturer shall affix th e 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 satis fies the applicable requirements of this 
Directive. 
5.2. The manufacturer shall draw up a written decl aration of conformity for each product 
model and keep it at the disposal of the nationa l authorities for 10 years after the product has 
been placed on the market. The declaration of conformity sha ll identify the product model for 
which it has been drawn up. EN 74   EN A copy of the declaration of conf ormity shall be made availabl e to the relevant authorities 
upon request. 
6. The manufacturer shall, fo r a period ending at least 10 y ears after the pr oduct has been 
placed on the market, keep at the dis posal 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 notifie d body referred to in points 3.5, 4.3 and 4.4. 
7. Each notified body shall inform its notifying au thorities of quality system approvals issued 
or withdrawn, and shall, periodically or upo n request, make availa ble to its notifying 
authorities the list of quality system approvals refused, suspe nded or otherwise restricted. 
Each notified body shall inform the other notifie d bodies of quality system approvals which it 
has refused, suspended, withdrawn or othe rwise 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. EN 75   EN  
Ð 94/9/EC 
ANNEX V  
MODULE: PRODUCT VERIFICATION  
1. This module describes the procedure wh ereby a manufacturer or his authorized 
repre sentative established within the Community c hecks and attests that the equipment 
subject to the provisions of point 3 are in conf ormity with the type as described in the EC -
type-examination certificate and satisfy the re levant requirements of the Directive.  
2. The manufacturer shall take all measures necessary to ensure that the manufacturing 
process guarantees conformity of the equipm ent with the type as described in the EC -type-
examination certificate and with the requi rements of the Directive which apply t o them. The 
manufacturer or his authorized representative es tablished in the Community shall affix the CE 
marking to each piece of equipment and sh all draw up a declaration of conformity.  
3. The notified body shall carry out the appropriate examinations an d 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 te sting every product as 
specified in Section 4.  
The manufacturer or his authorized representative shall ke ep a copy of the declaration of 
conformity for a period ending at least 10 y ears after the last pi ece of equipment was 
manufactured.  
4. VERIFICATION BY EXAMI NATION AND TESTING O F EACH PIECE OF EQUI PMENT . 
4.1. All equipment  shall be individually examined and appropriate tests as set out in the 
relevant stan dard(s) referred to in Article 5 o r equiva lent tests shall be carried ou t in order to 
verify their conformity with the type as described in the EC -type-examination certifi cate 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 cer tificate of conformity relating to the tests 
carried out.  
4.3. The manufacturer or his authori zed representative shall ensure that he is able to supply 
the notified body's certificates of conformity on request.  
 
Ø new 
MODULE: CONFORMITY TO  TYPE BASED ON PRODUCT VERIFICATION 
1. Conformity to type based on product verifica tion 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 responsib ility 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 requi rements of this Directive that apply to them. EN 76   EN 2. Manufacturing 
The manufacturer shall take all measures necessa ry so that the manufacturing process and its 
monitoring ensure conformity of the manufactur ed 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 manuf acturer shall carry out appropriate examinations and tests 
in order to check the conformity  of the products with the appr oved type described in the EU-
type examination certificate and with the a ppropriate requirements of this Directive. 
The examinations and tests to check the conf ormity 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 examin ation and testing of every product 
4.1. All products shall be individu ally examined and appropriate tests set out in the relevant 
harmonised standard(s) and/or technical specificati ons, or equivalent tests, shall be carried out 
in order to verify conformity with the appr oved 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 c onformity in respect of the examinations 
and tests carried out, and shal l affix its identification numbe r to each approved product or 
have it affixed under its responsibility. 
The manufacturer shall keep th e certificates of conformity available for inspection by the 
national authorities for 10 y ears after the product has been placed on the market. 
5. Conformity marking and declaration of conformity 
5.1. The manufacturer shall affix th e required conformity markings  set out in this Directive, 
and, under the responsibility of the notifie d 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 decl aration of conformity for each product 
model and keep it at the dispos al of the national authorities, fo r 10 years after the product has 
been placed on the market. The declaration of conformity sha ll identify the product model for 
which it has been drawn up. 
A copy of the declaration of conf ormity shall be made availabl e to the relevant authorities 
upon request. 
If the notified body referred to in point 3 agre es and under its responsib ility, the manufacturer 
may also affix the notified body's iden tification number to the products. EN 77   EN 6. If the notified body agrees a nd under its responsibility, th e manufacturer may affix the 
notified body's identification number to the products during the manu facturing 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 fulf il the manufacturer's obliga tions set out in point 2. EN 78   EN  
Ð 94/9/EC 
ANNEX VI  
MODULE: CONFORMITY TO TYPE  
1. This module describes that part of the procedure whereby the manufacturer or his 
authori zed 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-examinati on 
certificat e 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 declarati on of conformity.  
2. The manufacturer shall take all meas ures necessary to ensure that the manufacturing 
process assures compliance of th e manufactured equipment with the typ e as described in the 
EC-type-examination certificate and with the rele vant 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 y ears after the last pi ece 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 manufact ured, tests relating to the anti -explosive protection 
aspects of the pro duct shall be carried out by  the manufacturer or on hi s behalf. The tests shall 
be carried out under the res ponsibility of a notified body, c hosen by the manufacturer.  
On the responsibility of the notified body, th e manufacturer shall affix the former's 
identification number during the manufacturing process.  
 
Ø new 
MODULE: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION 
CONTROL PLUS SUPERVI SED PRODUCT TESTING 
1. Conformity to type based on internal producti on control plus supervis ed product testing is 
the part of a conformity assessment pro cedure whereby the manufacturer fulfils the 
obligations laid down in points 2, 3 and 4, and en sures 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 requireme nts of this Directive that apply to them. 
2. Manufacturing 
The manufacturer shall take all measures necessa ry so that the manufacturing process and its 
monitoring ensure conformity of the manufactur ed 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 EN 79   EN 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 th is Directive. The tests sh all be carried out under the 
responsibility of a notified body, chosen by the manufacturer. 
The manufacturer shall, under the responsibility of the notif ied 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 confor mity markings set out in this Directive to 
each individual product that is in conformity  with the type desc ribed in the EU-type 
examination certificate and satisfies the appl icable requirements of this Directive. 
4.2. The manufacturer shall draw up a written d eclaration 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 conf ormity shall identify the product model for 
which it has been drawn up. 
A copy of the declaration of conf ormity shall be made availabl e 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 respons ibility, provided that th ey are specified in 
the mandate. EN 80   EN  
Ð 94/9/EC 
ANNEX VII  
MODULE: PRODUCT QUALITY ASSURANCE  
1. This module describes the pr ocedure whereby the manuf acturer who satisfies the 
obligations of Section 2 ensures and declares that the equipmen t is in conformity with the 
type as described in the EC -type-examination certificate. The manu facturer or his authorized 
representative establ ished within the Community shall affix the CE marking to each product 
and draw up a written declarati on of conformity. The CE mark ing shall be accompanied by 
the identification number of the notified body re sponsible for surveillance as specified in 
Sectio n 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 manufacture r shall lodge an application for assessment of his quality syste m 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;  
– techn ical documentation on the approved type and a copy of the EC -type-
examination certificate.  
3.2. Under the quality system, each piece of eq uipment shall be examined and appropriate 
tests as set out in the relevant standa rd(s) referred to in Article 5 or equ ivalent tests shall be 
carried out in order to ensure its conformity wi th the relevant requirements of the Directive. 
All the elements, requirements and provisi ons adopted by the ma nufacturer shall be 
documented in a systematic and orderly manne r in the fo rm 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 o bjectives and the organizational struct ure, responsibilities and powers of 
the management with regard to product quality;  
– the examinations and tests which wi ll be carried out after manufacture;  
– the means to monitor the effective operation of the quality sy stem;  
– quality records, such as inspection reports and test data, calibration data, reports on 
the qualifications of th e personnel concerned, etc.  EN 81   EN 3.3. The notified body shall assess the quality syst em to determine whether it satisfies the 
requirements refe rred 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 me mber experienced as an assessor in the product 
technolog y concerned. The assessment procedure sh all include an assessment visit to the 
manufacturer's premises.  
The decision shall be notified to the manuf acturer. The notification shall contain the 
conclusions of the examination and the reasoned assessment decisi on. 
3.4. The manufacturer shall undertake to discharg e the obligations arising from the quality 
system as approved and to maintain it in an appropriate and efficient manner.  
The manufacturer or his au thorized representa tive shall inform the notified body w hich has 
approved the quality system of any in tended updating of th e 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 o r 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 TH E RESPONSIBILITY OF THE NOTIFIED BODY  
4.1. The purpose of surveillance is  to ensure that the manufactu rer duly fulfils the obligations 
arising out of the appr oved quality system.  
4.2. The manufacturer shall for inspection pur poses allow the notified body access to the 
inspection, testing and st orage 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 pers onnel concerned, etc.  
4.3. The notified body shall periodi cally carry out audits to en sure that the manufacturer 
maintains and applies the quality system and sh all provide an audit report to the manufacturer.  
4.4. Furthermore, the notified body may pay une xpected visits to the manufacturer. At the 
time of such visits, the notified body may carry out tests or arrang e 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:  EN 82   EN – the document ation referred to in the th ird indent of Section 3.1;  
– the updating referred to in the s econd paragraph of Section 3.4;  
– the decisions and reports from the notifie d body which are referred to in Section 3.4, 
last paragraph, Section 4.3 and Section 4.4.  
6. Ea ch notified body shall forward to the other notified bodies the relevant information 
concerning the quality syste m approvals issued and withdrawn.  
 
Ø new 
MODULE: CONFORMITY TO TYPE  BASED ON PRODUCT QUALITY 
ASSURANCE 
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 resp onsibility that the produ cts concerned are in 
conformity with the type described in the EU -type examination certificate and satisfy the 
requirements of this Direc tive 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 fo r 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, hi s name and address as well, 
– a written declaration that the same applic ation 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 appr oved type and a copy of the EU-type 
examination certificate. 
3.2. The quality system shall ensure compliance of the products with the t ype described in the 
EU-type examination certificate and with the ap plicable requirements of this Directive. 
All the elements, requirements and provisi ons adopted by the ma nufacturer shall be 
documented in a systematic and orderly manner in the form of written policies, procedures EN 83   EN and instructions. The quality system documentati on shall permit a consistent interpretation of 
the quality programmes, plans, manuals and records. 
It shall, in particular, contai n an adequate description of: 
– the quality objectives and the organisational structure, responsibi lities 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 effectiv e operation of the quality system. 
3.3. The notified body shall assess the quality syst em to determine whether it satisfies the 
requirements referred to in point 3.2. 
It shall presume conformity with those requireme nts in respect of the elements of the quality 
system that comply with th e corresponding specifica tions of the national standard that 
implements the relevant harmonised st andard 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 releva nt product field and product 
technology concerned, and knowledge of the appli cable requirements of this Directive. The 
audit shall include an assessment visit to the manufacturer's premises. The auditing team shall 
review the technica l documentation referred to in point 3.1, fi fth indent, in order to verify the 
manufacturer's ability to identify the relevant re quirements 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 manuf acturer. The notification shall contain the 
conclusions of the audit and th e reasoned assessment decision. 
3.4. The manufacturer shall undertake to fulfil the ob ligations arising out of  the quality system 
as approved and to maintain it so th at 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 requ irements 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 respons ibility of the notified body 
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the 
obligations arising out of th e approved quality system. EN 84   EN 4.2. The manufacturer shall, for assessment pur poses, allow the notified body access to the 
manufacture, inspection, testi ng and storage sites and shall pr ovide 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 aud its 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 repo rt and, if tests have been carr ied out, with a test report. 
5. Conformity marking and declaration of conformity 
5.1. The manufacturer shall affix th e 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 satis fies the applicable requirements of this 
Directive. 
5.2. The manufacturer shall draw up a written decl aration of conformity for each product 
model and keep it at the disposal of the nationa l authorities for 10 years after the product has 
been placed on the market. The declaration of conformity sha ll identify the product model for 
which it has been drawn up. 
A copy of the declaration of conf ormity shall be made availabl e to the relevant authorities 
upon request. 
6. The manufacturer shall, fo r a period ending at least 10 y ears after the product has been 
placed on the market, keep at the dis posal 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 notifie d body referred to in points 3.5, 4.3 and 4.4. 
7. Each notified body shall inform its notifying au thorities of quality system approvals issued 
or withdrawn, and shall, periodically or upo n request, make availa ble to its notifying 
authorities the list of quality system approvals refused, suspe nded or otherwise restricted. 
Each notified body shall inform the other notifie d bodies of quality system approvals which it 
has refused, suspended or withdrawn, and, upon reque st, of quality system approvals which it 
has issued. 
8. Authorised representative EN 85   EN 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. EN 86   EN  
Ð 94/9/EC 
ANNEX VIII  
MODUL: INTERNAL CONTROL OF PRODUCTION  
1. This module describes the procedure wher eby the manufacturer or his authorized 
representative established within the Community, who carries  out the obligations  laid down in 
Section 2, ensures and declare s that the equip ment satisfies the requirement s of the Directive 
applicable to it. The manufactur er or his authorized represen tative established within the 
Community shall affix the CE marking to each piece of eq uipment and draw up a written 
declaration of conformity.  
2. The manufacturer shall establish the technica l documentation describe d in Section 3 and he 
or his authorized representative established with in the Community shall keep it at the disposal 
of the re levant 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 authori zed representative is established within the 
Community, the obligati on 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 conf ormity of the equipment with the relevant 
requirements of the Direc tive to be assessed. It shall, to the extent necessary for such 
assessment, cover the design, manufacture and op eration of the product. It shall contain:  
– a general description of the equipment,  
– conceptual design and manufactur ing drawings and schemes of co mponents, sub -
assemblies, circuits, etc.,  
– descriptions and explanations  necessary for the understand ing 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 Di rective 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 d eclaration of 
conformity with the te chnical documentation.  
5. The manufacturer shall take all measures necessary to ensure that the manufacturing 
process guarantees compliance of the manu factured equipment with the technical 
documentation referred to in Se ction 2 and with the requirements of the Directive applicable 
to such equipment.  EN 87   EN  
Ø new 
MODULE: INTERNAL PR ODUCTION CONTROL 
1. Internal production control is the confor mity 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 estab lish the technical documentation. The documentation shall make 
it possible to assess the product's conformity to the re levant requirements, and shall include an 
adequate analysis and assessment of the risk(s). 
The technical documentation shall specify the a pplicable requirements a nd cover, as far as 
relevant for the assessment, the design, ma nufacture and operation of  the product. The 
technical documentation shall contai n at least the following elements: 
– a general description of the product, 
– conceptual design and manu facturing drawings and schemes of components, sub-
assemblies, circuits, etc. 
– descriptions and explanations  necessary for the understand ing of those drawings and 
schemes and the operation of the product, 
– a list of the harmonised standards and/or ot her 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 descriptio ns 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 even t 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 necessa ry so that the manufacturing process and its 
monitoring ensure comp liance of the manufactured products  with the technical documentation 
referred to in point 2 and with  the requirements of this Di rective that apply to them. 
4. Conformity marking and declaration of conformity 
4.1. The manufacturer shall affix the required confor mity markings set out in this Directive to 
each individual product that satisfies the appl icable requirements of this Directive. 
4.2. The manufacturer shall draw up a written d eclaration of conformity for a product model 
and keep it together with the technical documentation at the disposal of the national EN 88   EN authorities for 10 years after the product has be en 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 conf ormity shall be made availabl e 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 respons ibility, provided that th ey are specified in 
the mandate. EN 89   EN  
Ð 94/9/EC 
ANNEX IX  
MODULE: UNIT VERIFICATION  
1. This module desc ribes the procedure whereby the manuf acturer ensures and declares that 
the equipment or protective system which has b een issued with the certificate referred to in 
Section 2 conforms to the requi rements of the Directive whic h are applicable to it. The 
manu facturer or his authorized representative in the Community shall affix the CE marking to 
the equipment or protective system a nd 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 w ith the relevant requirements of the Directive.  
The notified body shall affix, or cause  to be affixed, its identificat ion 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 assesse d 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 manu facturing drawings and layouts of components, sub -
assemblie s, circuits, etc.;  
– descriptions and explanations  necessary for the understand ing of said drawings and 
layouts and the operation of the equipment or protective system;  
– a list of the standards referred to in Ar ticle 5, applied in full or in part, and 
descrip tions of the solutions adopted to m eet 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.  
 
Ø new 
MODULE: CONFORMITY BASE D ON UNIT VERIFICATION 
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 require ments of this Directive that apply to it. EN 90   EN 2. Technical documentation 
The manufacturer shall establish the technica l documentation and make it available to the 
notified body referred to in point 4. The docum entation shall make it possible to assess the 
product's conformity with the relevant requireme nts, 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 documen tation shall contain at least the following 
elements: 
– a general description of the product, 
– conceptual design and manu facturing drawings and schemes of components, sub-
assemblies, circuits, etc., 
– descriptions and explanations  necessary for the understand ing of those drawings and 
schemes and the operation of the product, 
– a list of the harmonised standards and/or ot her 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 descriptio ns 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 even t 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 th e technical documentation at th e disposal of the relevant 
national authorities for 10 y ears after the product has been placed on the market. 
3. Manufacturing 
The manufacturer shall take all measures necessa ry so that the manufacturing process and its 
monitoring ensure conformity of the manufactur ed product with the app licable requirements 
of this Directive. 
4. Verification 
A notified body chosen by the manufacturer shal l carry out appropriat e examinations and 
tests, set out in the relevant harmonised st andards and/or techni cal 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 cer tificate of conformity in resp ect of the examinations and 
tests carried out and shall affi x its identification number to the approved product, or have it 
affixed under its responsibility. EN 91   EN The manufacturer shall keep the certificates of conformity at  the disposal of the national 
authorities for 10 years after the pr oduct has been placed on the market. 
5. Conformity marking and declaration of conformity 
5.1. The manufacturer shall affix the required conf ormity markings set out in this Directive 
and, under the responsibility of the notifie d body referred to in point 4, the latter's 
identification number to each product that satis fies the applicable requirements of this 
Directive. 
5.2. The manufacturer shall draw up a written decl aration of conformity  and keep it at the 
disposal of the national aut horities for 10 years after the product has been placed on the 
market. The declaration of conformity shall id entify the product for which it has been drawn 
up. 
A copy of the declaration of conf ormity shall be made availabl e 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 respons ibility, provided that th ey are specified in 
the mandate. EN 92   EN  
Ð 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 pr oportions given in the above graduated drawing 
must be respected.  
The various components of the CE marking mu st have substantially  the same vertical 
dimension, which may not be less than 5  mm. 
This min imum 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 CONF ORMITY  
The EC declaration of conformity must contain the following elements:  
– the name or identificat ion mark and the address of the manufacturer or his authorized 
representative established within the Community;  
– a description of the equipmen t, protective system, or devi ce referred to in Article 1 
(2); 
– all relevant provisions fulfilled by the equipment, p rotective 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;  EN 93   EN – where appropriate, reference to the harmonized standards;  
– where appropriate, the standards and techni cal specifications which have been used;  
– where appropriate, references to other Community Directives which have been 
applied;  
– identification of the signatory who has b een empowered to enter into commitments 
on beha lf of the manufacturer or his authorized representative established within the 
Communit y. EN 94   EN 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 o ut the verification tests shall 
not be the designer, manufacturer , supplier or installer of equi pment, protective systems, or 
devices referred to in Article 1 (2) which they inspect, nor the authorized representative of 
any of these parties. They shall bec ome involved neither direc tly nor as authorized 
representatives in the design, construction, ma rketing or maintenan ce of the equipment, 
protective systems or devices referred to in Article 1 (2) in questi on. This does not preclude 
the possibility of exchan ges of technical information be tween the manufacturer and the body.  
2. The body and its inspection st aff shall carry out the verification tests with the highest 
degree of professional in tegrity and technical competence and shall be free from all pressures 
and inducements, particularly fina ncial, which may influence thei r 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 necessar y staff and possess the necessary facilities to 
enable it to perform properly the administ rative and technical tasks connected with 
verification; it shall also ha ve access to the equipment requi red for special verification.  
4. The staff responsible for ins pection 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 auth enticate the 
performance of the tests.  
5. The impartiality of inspection staff sha ll 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 unles s 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 obse rve professional secrecy with regard to all 
information gained in carry ing out its tasks (except vis-à-vis the competent administrative 
authorities of the State in which its activitie s are carried out) under this Directive or any 
provision of national law giving effect to it.  EN 95   EN  
Ï 
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 
   
_____________EN 96   EN ANNEX XI  
CORRELATION TABLE  
Directive 94/9/EC This Directive 
Article 1 (1) Article 1(1)(a) 
Article 1 (2) Article 1(1)(b) 
Article 1 (3), except the fourth subparagraph of 
the definition of " Equipment groups and 
categories " Article 2(1) to (9) 
– Article 2(10) to (26) 
Article 1 (3), fourth subparagraph of the 
definition of " Equipment groups and 
categories " Article 16(6) 
Article 1 (4) Article 1(2) 
Article 2 Article 3 
Article 3 Article 4 
Article 4 Article 5 
Article 5 (1), first subparagraph – 
Article 5 (1), second subparagraph Article 12(2) 
Article 5 (2) and (3)  – 
– Articles 6 to 11 
– Article 12(1) 
Article 6 – 
Article 7 – 
Article 8 (1) to (6) Article 13(1) to (6) 
Article 8 (7) – 
– Articles 14 and 15 
– Article 16(1) to (5) 
– Articles 17 to 39 EN 97   EN – Article 40(1) 
Articles 9 to 13 – 
Article 14(1) – 
Article 14(2) and (3) Article 40(2) and (3) 
Article 15(1) Article 41(1) 
Article 15(2) – 
– Article 41(2) 
– Article 42 
– Article 43 
Article 16 Article 44 
Annexes I to IX Annexes I to IX 
Annex X – 
Annex XI – 
– Annex X 
– Annex XI