CELEX: 52011PC0772
Language: en
Date: 2011-11-21
Title: 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

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		52011PC0772
		
			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 /* COM/2011/0772 final - 2011/0356 (COD) */
			
				
		
		
			
			   	EXPLANATORY MEMORANDUM

1.                      
context of the proposal

General context, reasons for and
objectives of this proposal
This proposal is presented in the framework
of the implementation of the “goods package” adopted in 2008. It is part
of a package of proposals aligning ten product directives to Decision No
768/2008/EC establishing a common framework for the
marketing of products.
Union (EU) harmonisation legislation
ensuring the free movement of products has contributed considerably to the
completion and operation of the Single Market. It is based on a high level of
protection and provides economic operators with the means to demonstrate
conformity, thus ensuring free movement through trust in the products.
Directive 94/9/EC (the ATEX Directive) is
an example of that Union harmonisation legislation, ensuring the free movement
of products. It sets out the essential health and safety requirements that
products must comply with in order to be made available on the EU market.
Manufacturers must demonstrate that a product has been designed and
manufactured in compliance with the essential health and safety requirements
and affix the CE marking. 
Experience with the implementation of Union
harmonisation legislation has shown – on a cross-sector scale - certain
weaknesses and inconsistencies in the implementation and enforcement of this
legislation, leading to
–     
the presence of non-compliant or dangerous
products on the market and consequently a certain lack of trust in CE marking,
–     
competitive disadvantages for economic operators
complying with the legislation as opposed to those circumventing the rules,
–     
unequal treatment in the case of non-compliant
products and distortion of competition amongst economic operators due to
different enforcement practices,
–     
differing practices in the designation of
conformity assessment bodies by national authorities, and
–     
problems with the quality of certain notified
bodies.
Furthermore the regulatory environment has
become more and more complex, as frequently several pieces of legislation apply
simultaneously to one and the same product. Inconsistencies in these pieces of
legislation make it increasingly difficult for economic operators and
authorities to correctly interpret and apply that legislation.
To remedy these horizontal shortcomings in
Union harmonisation legislation observed across several industrial sectors, the
"New Legislative Framework" was adopted in 2008 as part of the
goods package. Its objective is to strengthen
and complete the existing rules and to improve practical aspects of their
application and enforcement. The New Legislative Framework (NLF) consists of
two complementary instruments, Regulation (EC) No 765/2008 on accreditation
and market surveillance and Decision No 768/2008/EC establishing a
common framework for the marketing of products.
The NLF Regulation has introduced rules on
accreditation (a tool for the evaluation of competence of conformity assessment
bodies) and requirements for the organisation and performance of market
surveillance and controls of products from third countries. Since 1 January
2010 these rules apply directly in all Member States.
The NLF Decision sets out a common
framework for EU product harmonisation legislation. This framework consists of
the provisions which are commonly used in EU product legislation (e.g.
definitions, obligations of economic operators, notified bodies, safeguard
mechanisms, etc). These common provisions have been reinforced to ensure that
the directives can be applied and enforced more effectively in practice. New
elements, such as obligations on importers, have been introduced, which are
crucial for improving the safety of products on the market.
The provisions of the NLF Decision and
those of the NLF Regulation are complementary and closely interlinked. The NLF
Decision contains the corresponding obligations for economic operators and
notified bodies allowing market surveillance authorities and authorities
responsible for notified bodies to properly perform the tasks imposed on them
by the NLF Regulation and to ensure an effective and consistent enforcement of
EU product legislation.
However, unlike the NLF Regulation, the
provisions of the NLF Decision are not directly applicable. To ensure that all
economic sectors subject to Union harmonisation legislation benefit from the improvements
of the NLF, the provisions of the NLF Decision need to be integrated into the
existing product legislation.
A survey after the adoption of the goods
package in 2008 showed that a majority of Union harmonisation legislation on
products was due to be revised within the following 3 years, not only to
address the problems observed throughout all sectors but also for
sector-specific reasons. Any such revision would automatically include an
alignment of the legislation concerned to the NLF Decision since Parliament,
Council and Commission have committed themselves to use its provisions as much
as possible in future legislation on products in order to further the utmost
coherence of the regulatory framework.
For a number of other Union harmonisation
directives, including Directive 94/9/EC, no revision for sector-specific
problems had been envisaged within this timeframe. To ensure that the problems
in relation to non-compliance and notified bodies are nevertheless addressed in
these sectors, and for the sake of consistency of the overall regulatory
environment on products, it was decided to align these directives within a
package to the provisions of the NLF Decision.
Consistency with other policies and
objectives of the Union
This initiative is in
line with the Single Market Act[1],
which has stressed the need to restore consumer confidence in the quality of
products on the market and the importance of reinforcing market surveillance.
Furthermore it supports
the Commission’s policy on Better Regulation and simplification of the
regulatory environment.

2.                      
consultation of interested parties and impact
assessment

Consultation of interested parties
The alignment of the ATEX Directive 94/9/EC
to the NLF Decision has been discussed with national experts responsible for
the implementation of this Directive, the notified body group, the
administrative cooperation group as well as the representatives of industry
associations in the relevant experts working group.
From June to October 2010 a public
consultation was organised that comprised all the sectors involved in this
initiative. It consisted of four targeted questionnaires for economic
operators, authorities, notified bodies and users and the Commission services
received 300 replies. The results are published at http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/new-legislative-framework/index_en.htm.
In addition to the general consultation a
specific SME consultation was carried out. 603 SMEs were consulted through the
Enterprise Europe Network in May/June 2010. The results are available at http://ec.europa.eu/enterprise/policies/single-market-goods/files/new-legislative-framework/smes_statistics_en.pdf.
The consultation process revealed
widespread support for the initiative. There is unanimity on the need to
improve market surveillance and the system for assessing and monitoring
Notified Bodies. Authorities fully support the exercise because it will
strengthen the existing system and improve cooperation at EU level. Industry
expects a more level playing field resulting from more effective actions
against products that do not comply with the legislation, as well as a
simplification effect from the alignment of legislation. Certain concerns were
expressed on some obligations which are, however, indispensable for increasing
the efficiency of market surveillance. These measures will not entail significant
costs for industry, and the benefits resulting from improved market surveillance
should by far outweigh the costs.
Collection and use of expertise
The impact assessment for this
implementation package has largely built on the impact assessment carried out
for the New Legislative Framework. In addition to the expertise collected and analysed
in that context, further consultation of sector-specific experts and interest
groups, as well as horizontal experts active in the area of technical
harmonisation, conformity assessment, accreditation and market surveillance,
has taken place.
External expertise was used to obtain some
basic data on certain sectors: for the ATEX sector, the study "Market description, competitiveness analysis in the field of
products and protective systems 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
Commission carried out an impact assessment which examined and compared three
options.
Option 1 – No changes to the current
situation
This option proposes no changes to the
current directive and relies exclusively on certain improvements that can be expected
from the NLF Regulation.
Option 2 – Alignment to the NLF Decision
by non-legislative measures
Option 2 considers the possibility of
encouraging a voluntary alignment to the provisions set out in the NLF Decision
by, e.g., presenting them as best practices in guidance documents.
Option 3 – Alignment to NLF Decision by
legislative measures
This option consists in integrating the
provisions of the NLF Decision into the existing directives.
Option 3 was
found to be the preferred option because
–     
it will improve the competitiveness of companies
and notified bodies taking their obligations seriously, as opposed to those
cheating on the system;
–     
it will improve the functioning of the internal
market by ensuring equal treatment of all economic operators, notably importers
and distributors, as well as notified bodies;
–     
it does not entail significant costs for
economic operators and notified bodies; for those who are already acting
responsibly, no extra costs or only negligible costs are expected;
–     
it is considered more effective than option 2:
due to the lack of enforceability of option 2 it is questionable that the
positive impacts would materialise under that option;
–     
options 1 and 2 do not provide answers to the
problem of inconsistencies in the regulatory framework and therefore have no
positive impact on the simplification of the regulatory environment.

3.                      
Main elements of the proposal
3.1.                
Horizontal definitions

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

3.2.                
Obligations of economic operators and
traceability requirements

The proposal clarifies the obligations of
manufacturers and authorised representatives and introduces obligations for
importers and distributors. Importers must verify that the manufacturer has
carried out the applicable conformity assessment procedure and has drawn up a
technical documentation. They must also make sure with the manufacturer that
this technical documentation can be made available to authorities upon request.
Furthermore importers must verify that the products are correctly marked and
accompanied by the required documents, instructions and safety information.
They must keep a copy of the Declaration of conformity and indicate their name
and address on the product, or where this is not possible on the packaging or
the accompanying documentation. Distributors must verify that the product bears
the CE marking, the name of the manufacturer and of the importer, if relevant,
and that it is accompanied by the required documentation and instructions.
Importers and distributors must cooperate
with market surveillance authorities and take appropriate actions when they
have supplied non-compliant products.
Enhanced traceability obligations are introduced for all economic operators. Products have to bear
the manufacturer’s name and address and a number allowing to identify and link
the product to its technical documentation. When a product is imported the
importer’s name and address must also be on the product. Furthermore every
economic operator must be able to identify towards authorities the economic
operator who has supplied him with a product or to whom he has supplied a
product.

3.3.                
Harmonised standards

Compliance with harmonised standards
provides a presumption of conformity with the essential requirements. On 1 June
2011 the Commission adopted a proposal for a Regulation on European
Standardisation[2]
that sets out a horizontal legal framework for European standardisation. The
proposal for the Regulation contains inter alia provisions on standardisation
requests from the Commission to the European Standardisation Organisations, on
the procedure for objections to harmonised standards and on stakeholder participation
in the standardisation process. Consequently the provisions of Directive
94/9/EC which cover the same aspects have been deleted in this proposal for
reasons of legal certainty.
The provisions conferring presumption of
conformity to harmonised standards have been modified to clarify the extent of
the presumption of conformity when standards only partially cover the essential
requirements.

3.4.                
Conformity assessment and CE marking

Directive 94/9/EC has selected the
appropriate conformity assessment procedures which manufacturers have to apply
in order to demonstrate that their products comply with the essential health
and safety requirements. The proposal aligns these procedures to their updated
versions set out in the NLF Decision. Sector specific elements of the
procedures have been maintained.
General principles of the CE marking are
set out in Article 30 of Regulation 765/2008, while the detailed provisions on
the affixing of the CE marking and the specific marking of explosion protection
to products have been inserted in this proposal.

3.5.                
Notified Bodies

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

3.6.                
Market surveillance and the safeguard clause
procedure

The proposal revises the existing safeguard
clause procedure. It introduces a phase of information exchange between Member
States, and specifies the steps to be taken by the authorities concerned, when
a non-compliant product is found. A real safeguard clause procedure – leading
to a Decision at Commission level on whether a measure is justified or not – is
only launched when another Member State objects to a measure taken against a
product. Where there is no disagreement on the restrictive measure taken, all
Member States must take the appropriate action on their territory.

3.7.                
Comitology and Delegated acts

The provisions on the operation of standing
committees have to be adapted to the new rules on delegated acts laid down in
Article 290 of the Treaty on the Functioning of the EU and to the new
provisions on implementing acts laid down in Regulation (EU) No 182/2011 of the
European Parliament and of the Council of 16 February 2011 laying down the
rules and general principles concerning mechanisms for control by the Member
States of the Commission's exercise of implementing powers[3].
Directive 94/9/EC provided for a standing
committee. As this committee is not involved in the adoption of implementing
acts provided for in Article 291 of the Treaty on the Functioning of the EU, and
no need to adopt implementing acts appears under the new Directive, therefore
this provision has been deleted in the proposal.
The Commission will set up an expert
working group in accordance with the Communication from the President to the
Commission - Framework for Commission expert groups: horizontal rules and
public register (C(2010) 7649 final), that will carry out the tasks of the
standing committee provided for in Directive 94/9/EC, to examine any question
relating to the application of the Directive.

4.                      
legal elements of the proposal

Legal basis
The proposal is based on Article 114 of the
Treaty on the Functioning of the European Union.
Subsidiarity principle
The internal market is a competence that is
shared between the Union and the Member States. The subsidiarity principle
arises in particular with regard to the newly added provisions aiming at the
improvement of effective enforcement of Directive 94/9/EC, namely, the importer
and distributor obligations, the traceability provisions, the provisions on the
assessment and notification of notified bodies, and the enhanced cooperation
obligations in the context of the revised market surveillance and safeguard
procedures.
Experience with the enforcement of the
legislation has shown that measures taken at national level have led to
divergent approaches and to a different treatment of economic operators inside
the EU, which undermines the objective of this directive. If actions are taken
at national level to address the problems, this risks creating obstacles to the
free movement of goods. Furthermore action at national level is limited to the
territorial competence of a Member State. In view of the increasing
internationalisation of trade, the number of cross-border cases is constantly
rising. Coordinated action at EU level can much better achieve the objectives
set, and will in particular render market surveillance more effective. Hence it
is more appropriate to take action at EU level.
As regards the problem of inconsistencies
throughout the directives, this is a problem which can only be solved by the EU
legislator.
Proportionality
In accordance with the principle of
proportionality, the proposed modifications do not go beyond what is necessary
to achieve the objectives set. 
The new or modified obligations do not
impose unnecessary burdens and costs on industry - especially on small and
medium sized enterprises - or administrations. Where modifications have been identified
to have negative impacts, the analysis of the impacts of the option serves to
provide the most proportionate response to the problems identified. A number of
modifications concern the improvement of clarity of the existing Directive
without introducing new requirements that entail added cost. 
Legislative technique used
The alignment to the NLF Decision requires
a number of substantive amendments to the provisions of Directive 94/9/EC. To
ensure the readability of the amended text the technique of recasting has been
chosen in line with the Interinstitutional Agreement of 28 November 2001 on a
more structured use of the recasting technique for legal acts[4]. 
The changes made to the provisions of
Directive 94/9/EC concern: the definitions, the obligations of economic
operators, the presumption of conformity provided by harmonised standards, the
declaration of conformity, CE marking, notified bodies, the safeguard clause
procedure and the conformity assessment procedures.
The proposal does not change the scope of
Directive and the essential health and safety requirements.

5.                      
budgetary implications

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

6.                      
additional information

Repeal of existing legislation
The adoption of the proposal will lead to
repeal of Directive 94/9/EC.
European Economic Area
The proposal concerns the EEA and should
therefore be extended to the European Economic Area.
ê 94/9/EC
(adapted)
2011/0356 (COD)
Proposal for a
DIRECTIVE OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
on the approximation Ö harmonisation Õ of the laws of
the Member States concerning
Ö relating
to Õ equipment and
protective systems intended for use in potentially explosive atmospheres
(Recast)
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European
Community Ö on the
Functioning of the European Union Õ , and in
particular Article 100a
Ö 114 Õ thereof,
Having regard to the proposal from the European
Commission,
After transmission of the draft legislative
act to the national Parliaments,
Having regard to the opinion of the European
Economic and Social Committee[5],
Acting in accordance with the ordinary
legislative procedure,
Whereas:
ò new
(1)              
Directive 94/9/EC of
the European Parliament and the Council of 23 March 1994 on the approximation
of the laws of the Member States concerning equipment and protective systems
intended for use in potentially explosive atmospheres[6] 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 the Council of 9 July 2008 setting
out the requirements for accreditation and market surveillance relating to the
marketing of products and repealing Regulation (EEC) No 339/93[7] lays down rules on the
accreditation of conformity assessment bodies, provides a framework for the
market surveillance of products and for controls on products from third
countries, and lays down the general principles of the CE marking.
(3)              
Decision No
768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a
common framework for the marketing of products, and repealing Council Decision
93/465/EEC[8]
lays down a common framework of general principles and reference provisions
intended to apply across the legislation harmonising the conditions for the
marketing of products in order to provide a coherent basis for revision or
recasts of that legislation. Directive 94/9/EC should therefore be adapted to
that Decision.
ê 94/9/EC
recital 1 (adapted)
(4)              
Whereas iIt is the duty of Member States to
protect, on their territory, the safety and health of persons and, where
appropriate, domestic animals and property and, in particular, that of workers,
especially against the hazards resulting from the use of equipment and systems
providing protection against potentially explosive atmospheres;.
ê 94/9/EC
recital 2 (adapted)
Whereas mandatory provisions within the Member
States determine the level of safety to be achieved by protective equipment and
systems intended for use in potentially explosive atmospheres; whereas these
are generally electrical and non-electrical specifications having an effect on the design and structure of equipment which can be
used in potentially explosive atmospheres;
ê 94/9/EC
recital 3 (adapted)
Whereas the requirements to be met by such
equipment differ from one Member State to another in respect of their extent
and differing inspection procedures; whereas these differences are, therefore,
likely to raise barriers to trade within the Community;
ê 94/9/EC
recital 4 (adapted)
Whereas harmonization
of national legislation is the only way in which to remove these barriers to
free trade; whereas this
objective cannot be satisfactorily achieved by the individual Member States;
whereas this Directive merely lays down the requirements
vital to freedom of movement for the
equipment to which it applies;
ê 94/9/EC
recital 5 (adapted)
Whereas the regulations intended to remove
technical barriers to trade are required to follow the new approach provided
for in the Council resolution of 7 May 1985[9], which
requires a definition of the essential requirements regarding safety and
other requirements of society without reducing existing, justified levels of
protection within the Member States; whereas that resolution provides that a
very large number of products be covered by a single Directive in order to avoid frequent amendments and the
proliferation of Directives;
ê 94/9/EC
recitals 6 and 8 (adapted)
(5)              
Whereas the existing Directives Ö 94/9/EC Õ on the approximation of
the laws of the Member States to electrical equipment for use in potentially
explosive atmospheres have Ö has Õ made positive
steps towards Ö effective Õ protection
against explosions via
measures linked with the structure of the equipment at issue and which have
helped to remove barriers to trade in this area; whereas, in parallel, a
revision and expansion of the existing Directives is necessary since, more
particularly, in an overall context, action must be taken to guard against the potential hazards arising from
such equipment. This implies in particular that measures intended to guarantee
effective protection of users and third parties must already be contemplated at
the design and manufacturing states; Ö hazards
for both mining and surface equipment. Those Õ Whereas the two
groups of equipment referred
to above are used in a large number of commercial and
industrial sectors and possess considerable economic significance.
ê 94/9/EC
recital 7 (adapted)
Whereas the form taken by the hazard, the
protective measures and the test methods are often very similar, if not
identical, for both mining and surface equipment; whereas it is, therefore,
absolutely necessary to cover by a single Directive protective equipment and
systems falling within both groups;
ê 94/9/EC
recital 9 (adapted)
(6)              
Whereas cCompliance with the basic safety and
health Ö and
safety Õ requirements
is essential in order to ensure the safety of protective equipment and systems.; whereas tThose requirements have been
Ö should
be Õ subdivided into
general and additional requirements which must Ö need to Õ be met by
protective equipment and systems.; whereas,
In particular, the additional requirements are intended to Ö should Õ take account
of existing or potential hazards.; whereas Protective equipment
and systems will
Ö should Õ , 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 Ö that Õ equipment,
stating its use in a potentially explosive atmosphere, is also necessary.
ê 94/9/EC
recital 10 (adapted)
Whereas the intention is to prepare a Directive on
operations in potentially explosive atmospheres which is based on Article 118a;
whereas that additional Directive will, in particular, aim at explosion hazards
which derive from a given use and/or types and methods of installation;
ê 94/9/EC
recital 11 (adapted)
(7)              
Whereas cCompliance with Ö the Õ essential
health and safety requirements is imperative if Ö in order
to ensure Õ the safety of
equipment is to be
ensured.; whereas judgment will have to be exercised in
Ö For Õ the
implementation of those requirements Ö , both
the technology obtained at the time of manufacture and overriding technical and
economic requirements Õ in order to take Ö should be
taken into Õ account of both the technology
obtaining at the time of manufacture and overriding technical and economic
requirements.
ê 94/9/EC
recital 12 (adapted)
Whereas, therefore,
this Directive sets out essential requirements only;
whereas, in order to facilitate the task of proving
compliance with the essential requirements, harmonized European standards
are necessary, more especially with regard to the non-electrical aspects of
protection against explosions — standards relating to the design, manufacture
and testing of equipment, compliance with which enables a product to be
presumed to meet such essential requirements;
whereas harmonized European standards are
drawn up by private bodies and must retain their
non-mandatory status; whereas, for this purpose, the European
Committee for Standardization (CEN) and the European Committee for
Electrotechnical Standardization (Cenelec) are recognized as the bodies
competent to adopt harmonized standards which follow the general guidelines for
cooperation between the Commission and those two bodies, signed on 13 November
1984; whereas, for the
purposes of this Directive, a harmonized standard is a technical
specification (European Standard or harmonization document) adopted by one or
other of those bodies, or by both, at the prompting of the Commission pursuant
to Council Directive 83/189/EEC of the 28 March 1983 providing for a procedure governing the provision of information on
technical standards and regulations[10] and
pursuant to the general guidelines referred to
above;
ê 94/9/EC
recital 13 (adapted)
Whereas the legislative framework should be improved
in order to ensure that employers and workers make an effective and appropriate
contribution towards the standardization process; whereas this should be
completed by the time this Directive is implemented;
ê 94/9/EC
recital 14 (adapted)
Whereas, in view
of the nature of the risks involved in the use of equipment in potentially
explosive atmospheres it is necessary to establish procedures applying to the
assessment of compliance with the basic requirements of the Directives;
whereas these procedures must be devised in the light of
the level of risk which may be inherent in equipment and/or against which
systems must protect the immediate environment; whereas, therefore,
each category of equipment conformity must be supplemented by an adequate
procedure or a choice between several
equivalent procedures; whereas the procedures adopted comply
fully with Council Decision 93/465/EEC of 22 July 1993 concerning the modules
for the various phases of the conformity assessment procedures which are
intended to be used in the technical harmonization Directives[11];
ê 94/9/EC
recital 15 (adapted)
Whereas the Council
has provided for the affixing of the
CE marking by either the manufacturer or his authorized representative within
the Community; whereas that
marking means that the product complies with all the basic requirements and
assessment procedures provided for by the Community law
applying to that product;
ê 94/9/EC
recital 16 (adapted)
Whereas it is
appropriate that the Member States, as provided for by Article 100a of the
Treaty, may take temporary measures to limit or prohibit the placing on the
market and the use of equipment and protective systems in cases where they
present a particular risk to the safety of persons and, where appropriate, domestic animals or property, provided that the
measures are subject to a Community control procedure;
ê 94/9/EC
recital 17 (adapted)
Whereas the
recipients of any decision taken as part of this Directive must be aware of
the reasons behind that decision and the means
of appeal open to them;
ê 94/9/EC
recital 18 (adapted)
Whereas, on 18 December 1985, the Council adopted
a framework Directive on electrical equipment for use in potentially explosive
atmospheres (76/117/EEC)[12] and, on
15 February 1982, a Directive concerning electrical equipment for use in
potentially explosive atmospheres in mines susceptible to fire damp
(82/130/EEC)[13];
whereas, from the outset of harmonization work, the conversion into total
harmonization of the optional and partial harmonization on which these
Directives are based had been contemplated; whereas this Directive fully covers
the scope of the abovementioned Directives and whereas, therefore, these
Directives must be repealed;
ê 94/9/EC
recital 19 (adapted)
Whereas the
internal market incorporates an area without internal frontiers within which
the free movement of goods, persons, services and capital is assured;
ê 94/9/EC
recital 20 (adapted)
Whereas it is necessary to provide for a
transitional arrangement enabling equipment manufactured in compliance with the
national regulations in force at the date of adoption of this Directive to be
marketed and placed in service;
ò new
(8)              
Economic operators
should be responsible for the compliance of products, in relation to their
respective roles in the supply chain, so as to ensure a high level of
protection of public interests, such as health and safety, and the protection
of end-users and of the environment, and to guarantee fair competition on the
Union market.
(9)              
All economic operators
intervening in the supply and distribution chain should take appropriate
measures to ensure that they make available on the market only products which
are in conformity with this Directive. It is necessary to provide for a clear
and proportionate distribution of obligations which correspond to the role of
each operator in the supply and distribution process.
(10)          
The manufacturer,
having detailed knowledge of the design and production process, is best placed
to carry out the complete conformity assessment procedure. Conformity
assessment should therefore remain the obligation of the manufacturer alone.
(11)          
It is necessary to
ensure that products from third countries entering the Union market comply with
the requirements of this Directive, and in particular that appropriate
assessment procedures have been carried out by manufacturers with regard to
those products. Provision should therefore be made for importers to make sure that
the products they place on the market comply with the requirements of this
Directive and that they do not place on the market products which do not comply
with such requirements or present a risk. Provision should also be made for
importers to make sure that conformity assessment procedures have been carried
out and that product marking and documentation drawn up by manufacturers are
available for inspection by the supervisory authorities.
(12)          
The distributor makes
a product available on the market after it has been placed on the market by the
manufacturer or the importer and should act with due care to ensure that its
handling of the product does not adversely affect the compliance of the
product.
(13)          
When placing a product
on the market, every importer should indicate on the product his name and the
address at which he can be contacted. Exceptions should be provided for in
cases where the size or nature of the product does not allow it. This includes
cases where the importer would have to open the packaging to put his name and
address on the product.
(14)          
Any economic operator
that either places a product on the market under his own name or trademark or
modifies a product in such a way that compliance with the requirements of this
Directive may be affected should be considered to be the manufacturer and
should assume the obligations of the manufacturer.
(15)          
Distributors and
importers, being close to the market place, should be involved in market
surveillance tasks carried out by the competent national authorities, and should
be prepared to participate actively, providing those with all necessary
information relating to the product concerned.
(16)          
Ensuring traceability
of a product throughout the whole supply chain helps to make market
surveillance simpler and more efficient. An efficient traceability system
facilitates market surveillance authorities' task of tracing economic operators
who made non-compliant products available on the market.
(17)          
This Directive should
be limited to the expression of the essential health and safety requirements. In
order to facilitate conformity assessment with those requirements it is
necessary to provide for presumption of conformity for products which are in
conformity with harmonised standards that are adopted in accordance with Regulation (EU) No [../..] of the European
Parliament and of the Council of […..] on European Standardisation and amending
Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC,
95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/105/EC and 2009/23/EC
of the European Parliament and of the Council[14] for the purpose of expressing detailed
technical specifications of those requirements.
(18)          
Regulation (EU) No
[../..] [on European Standardisation] provides for a procedure for objections
to harmonised standards where those standards do not entirely satisfy
requirements of this Directive.
(19)          
In order to enable economic
operators to demonstrate and the competent authorities to ensure that products
made available on the market conform to the essential health and safety requirements
it is necessary to provide for conformity assessment procedures. Decision No
768/2008/EC establishes modules for conformity assessment procedures, which
include procedures from the least to the most stringent, in proportion to the
level of risk involved and the level of safety required. In order to ensure inter-sectoral
coherence and to avoid ad-hoc variants, conformity assessment procedures should
be chosen from among those modules.
(20)          
The manufacturer
should draw up an EU declaration of conformity to provide detailed information
on the conformity of a product with the requirements of this Directive.
(21)          
The CE marking,
indicating the conformity of a product, is the visible consequence of a whole
process comprising conformity assessment in a broad sense. General principles
governing the CE marking are set out in Regulation (EC) No 765/2008. Rules
governing the affixing of the CE marking should be laid down in this Directive.
(22)          
The conformity assessment
procedures set out in this Directive require the intervention of conformity
assessment bodies, which are notified by the Member States to the Commission.
(23)          
Experience has shown
that the criteria set out in Directive 94/9/EC that conformity assessment
bodies have to fulfil to be notified to the Commission are not sufficient to
ensure a uniformly high level of performance of notified bodies throughout the
Union. It is, however, essential that all notified bodies perform their
functions to the same level and under conditions of fair competition. That
requires the setting of obligatory requirements for conformity assessment
bodies wishing to be notified in order to provide conformity assessment
services.
(24)          
In order to ensure a
consistent level of quality in the performance of conformity assessment it is
also necessary to set requirements for notifying authorities and other bodies
involved in the assessment, notification and monitoring of notified bodies.
(25)          
If a conformity
assessment body demonstrates conformity with the criteria laid down in
harmonised standards, it should be presumed to comply with the corresponding
requirements set out in this Directive.
(26)          
The system set out in
this Directive should be complemented by the accreditation system provided for
in Regulation (EC) No 765/2008. Since accreditation is an essential means of
verifying the competence of conformity assessment bodies, it should also be
used for the purposes of notification.
(27)          
Transparent
accreditation as provided for in Regulation (EC) No 765/2008, ensuring the
necessary level of confidence in conformity certificates, should be considered
by the national public authorities throughout the Union as the preferred means
of demonstrating the technical competence of conformity assessment bodies.
However, national authorities may consider that they possess the appropriate
means of carrying out this evaluation themselves. In such cases, in order to
ensure the appropriate level of credibility of evaluations carried out by other
national authorities, they should provide the Commission and the other Member States
with the necessary documentary evidence demonstrating the compliance of the
conformity assessment bodies evaluated with the relevant regulatory requirements.
(28)          
Conformity assessment
bodies frequently subcontract parts of their activities linked to the assessment
of conformity or have recourse to a subsidiary. In order to safeguard the level
of protection required for the products to be placed on the Union market, it is
essential that conformity assessment subcontractors and subsidiaries fulfil the
same requirements as notified bodies in relation to the performance of
conformity assessment tasks. Therefore, it is important that the assessment of
the competence and the performance of bodies to be notified and the monitoring
of bodies already notified cover also activities carried out by subcontractors
and subsidiaries.
(29)          
It is necessary to
increase the efficiency and transparency of the notification procedure and, in
particular, to adapt it to new technologies so as to enable online notification.
(30)          
Since notified bodies
may offer their services throughout the Union, it is appropriate to give the
other Member States and the Commission the opportunity to raise objections
concerning a notified body. It is therefore important to provide for a period
during which any doubts or concerns as to the competence of conformity
assessment bodies can be clarified before they start operating as notified
bodies.
(31)          
In the interests of
competitiveness, it is crucial that notified bodies apply the conformity
assessment procedures without creating unnecessary burdens for economic
operators. For the same reason, and to ensure equal treatment of economic
operators, consistency in the technical application of the conformity assessment
procedures must be ensured. That can best be achieved through appropriate
coordination and cooperation between notified bodies.
(32)          
In order to ensure
legal certainty, it is necessary to clarify that rules on Union market
surveillance and control of products entering the Union market provided for in
Regulation (EC) No 765/2008 apply to products covered by this Directive. This
Directive should not prevent Member States from choosing the competent
authorities to carry out those tasks.
(33)          
Directive 94/9/EC already
provides for a safeguard procedure. In order to increase transparency and to
reduce processing time, it is necessary to improve the existing safeguard
clause procedure, with a view to making it more efficient and drawing on the
expertise available in Member States.
(34)          
The existing system
should be supplemented by a procedure under which interested parties are
informed of measures intended to be taken with regard to products presenting a
risk to the health and safety of persons or to other aspects of public interest
protection. It should also allow market surveillance authorities, in
cooperation with the relevant economic operators, to act at an earlier stage in
respect of such products.
(35)          
Where the Member
States and the Commission agree as to the justification of a measure taken by a
Member State, no further involvement of the Commission should be required,
except where non-compliance can be attributed to shortcomings of a harmonised
standard.
(36)          
The Member States
should lay down rules on penalties applicable to infringements of the national
provisions adopted pursuant to this Directive and ensure that they are
implemented. Those penalties should be effective, proportionate and dissuasive.
(37)          
It is necessary to
provide for transitional arrangements that allow making available on the market
and putting into service of products that have already been placed on the
market in accordance with Directive 94/9/EC.
(38)          
Since the objective of
this Directive, namely to ensure that products on the market fulfil the
requirements providing a high level of protection of health and safety and
other public interests while guaranteeing the functioning of the internal
market, cannot be sufficiently achieved by the Member States and can therefore,
by reason of its scale and effects, be better achieved at Union level, the
Union may adopt measures, in accordance with the principle of subsidiarity as
set out in Article 5 of the Treaty on European Union. In accordance with the
principle of proportionality, as set out in that Article, this Directive does
not go beyond what is necessary in order to achieve that objective.
(39)          
The obligation to
transpose this Directive into national law should be confined to those
provisions which represent a substantive change as compared with Directive
94/9/EC. The obligation to transpose the provisions which are unchanged arises under
Directive 94/9/EC.
(40)          
This Directive should
be without prejudice to the obligations of the Member States relating to the
time-limits for transposition into national law and application of the
Directive 94/9/EC set out in Annex X, Part B,
ê 94/9/EC
HAVE ADOPTED THIS DIRECTIVE:
CHAPTER I1
ê 94/9/EC
(adapted)
Scope, placing on the market and freedom of
movement Ö General
provisions Õ
Article 1
Ö Scope Õ
1. This Directive applies Ö shall
apply Õ to Ö the
following products: Õ
ê 94/9/EC
(a) equipment and protective systems intended for use in potentially
explosive atmospheres.;
ê 94/9/EC
(adapted)
(b) 2. Ssafety
devices, controlling devices and regulating devices intended for use outside
potentially explosive atmospheres but required for or contributing to the safe
functioning of equipment and protective systems with respect to the risks of explosion
are also covered by
the scope of this Directive.
4.2. Ö This
Directive shall not apply to Õ Tthe following are excluded from the scope of this Directive
Ö products Õ :
ê 94/9/EC
–                        
medical devices intended for use in a medical
environment;
–                        
equipment and protective systems where the
explosion hazard results exclusively from the presence of explosive substances or
unstable chemical substances;
–                        
equipment intended for use in domestic and
non-commercial environments where potentially explosive atmospheres may only
rarely be created, solely as a result of the accidental leakage of fuel gas;
–                        
personal protective equipment covered by Council Directive 89/686/EEC[15];
–                        
seagoing vessels and mobile offshore units
together with equipment on board such vessels or units;
–                        
means of transport, i.e. vehicles and their
trailers intended solely for transporting passengers by air or by road, rail or
water networks, as well as means of transport in so far as such means are
designed for transporting goods by air, by public road or rail networks or by
water. Vehicles intended for use in a potentially explosive atmosphere shall
not be excluded;
–                        
the equipment covered by Article 223346(1)(b) of the Treaty.
ê 94/9/EC
(adapted)
Article
2
Ö Definitions Õ
3.For
the purposes of this Directive, the following definitions shall
apply:
Equipment and protective systems intended for use
in potentially explosive atmospheres
ê 94/9/EC
è1 Corrigendum, OJ L 21, 26.1.2000, p. 42
(1) (a) 'Eequipment' means machines, apparatus,
fixed or mobile devices, control components and instrumentation thereof and
detection or prevention systems which, separately or jointly, are intended for
the generation, transfer, storage, measurement, è1 control and conversion of energy and/or the
processing ç of material
and which are capable of causing an explosion through their own potential
sources of ignition.;
ê 94/9/EC
è1 Corrigendum, OJ L 21, 26.1.2000, p. 42
ð new
(2) (b) è1 'Pprotective systems' means devices other
than components of the equipment defined above which are intended to halt
incipient explosions immediately and/or to limit the effective range of an
explosion and which are separately placed
ð made available ï on the market for use as autonomous systems. ç ;
ê 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
(4) Ö 'explosive
atmosphere' means a Õ 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) Ö 'potentially
explosive atmosphere' means Õ Aan atmosphere which could become
explosive due to local and operational conditions.;
Equipment groups and categories
ê 94/9/EC
(adapted)
è1 Corrigendum, OJ L 304, 5.12.2000, p. 19
(6) 'Eequipment group I' applies Ö means Õ equipment
intended for use è1 in underground parts of mines, and in those parts
of ç surface
installations of such mines, liable to be endangered by firedamp and/or combustible
dust.
Ö ,
comprising categories M1 and M2 as set out in Annex I; Õ
ê 94/9/EC
(adapted)
(7) 'Eequipment group II' applies Ö means Õ equipment
intended for use in other places liable to be endangered by explosive
atmospheres. Ö , comprising
categories 1, 2 and 3 as set out in Annex I; Õ
(8) Ö 'category
of equipment' means the definition of the required levels of protection,
as referred to Õ The categories of
equipment defining the required levels of protection are described
in Annex I.;
Equipment and protective systems may be designed
for a particular explosive atmosphere. In this case, they must be marked
accordingly.
Intended use
(9) Ö 'intended
use' means Õ Tthe use of equipment, protective systems, and devices
referred to in Article 1 (2) Ö products Õ 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. Ö products; Õ
ò new
[Article R1 of
Decision No 768/2008/EC]
(10) 'making
available on the market' means any supply of a product for distribution,
consumption or use on the Union market in the course of a commercial activity,
whether in return for payment or free of charge;
(11) 'placing on
the market' means the first making available of a product on the Union market;
(12) 'manufacturer'
means any natural or legal person who manufactures a product or has a product designed
or manufactured, and markets that product under his name or trademark;
(13) 'authorised
representative' means any natural or legal person established within the Union
who has received a written mandate from a manufacturer to act on his behalf in
relation to specified tasks;
(14) 'importer'
means any natural or legal person established within the Union who places a
product from a third country on the Union market;
(15) 'distributor'
means any natural or legal person in the supply chain, other than the
manufacturer or the importer, who makes a product available on the market;
(16) 'economic
operators' means the manufacturer, the authorised representative, the importer
and the distributor;
(17) 'technical
specification' means a document that prescribes technical requirements to be
fulfilled by a product, process or service;
(18) 'harmonised
standard' means harmonised standard as defined in Article 2(1)(c) of Regulation
(EU) No [../..] [on European Standardisation];
(19) 'accreditation'
means accreditation as defined in Article 2(10) of Regulation (EC) No 765/2008;
(20) 'national
accreditation body' means accreditation body as defined in Article 2(11) of Regulation
(EC) No 765/2008;
(21) 'conformity
assessment' means the process demonstrating whether the essential health and
safety requirements relating to a product, process, service or system have been
fulfilled;
(22) 'conformity
assessment body' means a body that performs conformity assessment activities
including calibration, testing, certification and inspection;
(23) 'recall'
means any measure aimed at achieving the return of a product that has already
been made available to the end user;
(24) 'withdrawal'
means any measure aimed at preventing a product in the supply chain from being
made available on the market;
(25) 'CE marking'
means a marking by which the manufacturer indicates that the product is in
conformity with the applicable requirements set out in Union harmonisation
legislation providing for its affixing;
(26) 'Union harmonisation
legislation' means any Union legislation harmonising the conditions for the
marketing of products.
ê 94/9/EC
(adapted)
ð new
Article 23
Ö Making
available on the market Õ
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 Ö products Õ may be placed ð made available ï on the market and put into service only if, when properly installed
and maintained and used for Ö in
accordance with Õ their intended
purpose, they do not endanger the health
and safety of persons and, where appropriate, domestic animals or property
Ö comply
with this Directive Õ . 
2. The provisions of tThis Directive shall not affect Member States'
entitlement to lay down, in due observance of the provisions of the Treaty,
such requirements as they may deem necessary to ensure that persons and, in
particular, workers are protected when using the equipment, protective systems, and devices
referred to in Article 1 (2) in question Ö relevant
products Õ provided that
this does not mean that such equipment, protective systems, or devices Ö products Õ are modified
in a way not specified in the Ö this Õ Directive.
3. At trade fairs, exhibitions, Ö and Õ demonstrations,
etc.,
Member States shall not prevent the showing of equipment, protective systems, or the devices
referred to in Article 1 (2) Ö products Õ which do not conform to the provisions
of Ö comply
with Õ this
Directive, provided that a visible sign clearly indicates that such equipment, protective
systems, and devices referred to in Article 1 (2) Ö products Õ do not conform
Ö comply Õ and that they
are not for sale until they have been brought into conformity by the
manufacturer or his authorized representative established in the Community
Ö Union Õ . During
demonstrations, adequate safety measures shall be taken to ensure the
protection of persons.
ê 94/9/EC
(adapted)
Article 34
Ö Essential
health and safety requirements Õ
Equipment, protective systems, and the devices
referred to in Article 1 (2) to which this Directive applies must Ö Products shall Õ meet the essential
health and safety requirements set out in Annex II which apply to them, account
being taken of their intended use.
ê 94/9/EC
(adapted)
è1 Corrigendum, OJ L 21, 26.1.2000, p. 42
ð new
Article 45
Ö Free
movement Õ
1. Member States shall not prohibit,
restrict or impede the placing ð making available ï on the market and putting into service in their territory of equipment, protective
systems, or devices referred to in Article 1 (2) Ö products Õ which comply
with this Directive.
2. Member States shall not prohibit,
restrict or impede the placing ð making available ï on the market of components which, è1 accompanied by a written attestation of conformity
as referred to in Article 8(3) ç 13(3), are intended to be incorporated into
equipment or
protective systems Ö products Õ within the
meaning of this Directive.
ê 94/9/EC
Article 5
1. Member States shall regard as conforming to all the
provisions of this Directive, including the relevant conformity assessment
procedures laid down in chapter II:
–                        
equipment,
protective systems, and devices referred to in Article 1 (2) accompanied by the
EC declaration of conformity referred to in Annex X and bearing the CE
marking provided for in Article 10,
–                        
the components
referred to in Article 4 (2), accompanied by the certificate of conformity
referred to in Article 8 (3).
In the absence of
harmonized standards, Member States shall take any steps which they deem
necessary to bring to the attention of the parties concerned the existing
national technical standards and specifications regarded as important or
relevant to the proper implementation of the essential health and safety requirements in Annex II.
2. Where a
national standard transposing a harmonized standard, the reference for which
has been published in the
Official Journal of the European Communities, covers one or more of the essential health and
safety requirements, the equipment, protective system, device referred to in
Article 1 (2), or the component referred to in Article 4 (2), constructed in
accordance with that standard shall be presumed to comply with the relevant
essential health and safety requirements.
Member States
shall publish the references of national standards transposing harmonized
standards.
3. Member States shall ensure that appropriate
measures are taken to enable the social partners to influence the process of
preparing and monitoring the harmonized standards at national level.
Article 6
1. Where a Member
State or the Commission considers that the harmonized standards referred to in
Article 5 (2) do not entirely satisfy the relevant essential health and safety
requirements referred to in Article 3, the Commission or the Member State
concerned shall bring the matter before the Committee set up under Directive
83/189/EEC, hereinafter referred to as «the Committee'», giving reasons
therefor. The Committee shall deliver an opinion without delay.
Upon receipt of
the Committee's opinion, the Commission shall inform the Member States whether
or not it is necessary to withdraw those standards from the published
information referred to in Article 5 (2).
2. The Commission
may adopt any appropriate measure with a view to ensuring the practical
application in a uniform manner of this Directive in accordance with the
procedure laid down in paragraph 3.
ê Regulation
(EC) No 1882/2003
3. The Commission
shall be assisted by a standing committee (hereinafter referred to as 'the
Committee'.
Where reference is
made to this paragraph, Articles 3 and 7 of Decision 1999/486/EC[16] shall apply, having regard to the provisions of
Article 8 thereof.
The Committee
shall adopt its rules of procedure.
ê 94/9/EC
4. The Standing
Committee may furthermore examine any question relating to the application of
this Directive and raised by its chairman either on the latter's initiative, or
at the request of a Member State.
Article 7
ê 94/9/EC
1. When a Member State ascertains that equipment, protective systems or devices referred
to in Article 1 (2) bearing the CE conformity marking and used in accordance
with their intended use are liable to endanger the safety of persons and, where
appropriate, domestic animals or property, it shall take all appropriate measures to withdraw such equipment or protective systems from
the market, to prohibit the placing on the market, putting into service or use
thereof, or to restrict free movement thereof.
The Member
State shall immediately inform the Commission of any such measure, indicating
the reasons for its decision and, in particular, whether non-conformity is due
to:
(a)          failure
to satisfy the essential requirements referred to in Article 3;
(b)          incorrect 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 consultation with the parties concerned without delay. Where
the Commission considers, after this consultation, that the measure is
justified, it shall immediately so inform the Member State which took the
initiative and the other Member States. Where the Commission considers, after
this consultation, that the action is unjustified, it shall immediately so inform the Member State which took the
initiative and the manufacturer or his authorized representative established
within the Community. Where the decision referred to in paragraph 1 is based on
a shortcoming in the standards and where the Member State at the origin of
the decision maintains its position, the Commission shall immediately inform
the Committee in order to initiate the procedures referred to in Article 6 (1).
3. Where equipment, a protective system or a device
referred to in Article 1(2) which does not comply bears the CE conformity marking,
the competent Member State shall take appropriate action against the person(s)
having affixed the marking and shall so inform the Commission and the other
Member States.
4. The Commission
shall ensure that the Member States are kept informed of the progress and
outcome of this procedure.
ò new
CHAPTER 2
Obligations of economic operators
Article 6
[Article R2 of Decision No 768/2008/EC]
Obligations of
manufacturers
1. When placing
their products on the market, manufacturers shall ensure that they have been
designed and manufactured in accordance with the essential health and safety requirements
set out in Annex II.
2. Manufacturers
shall draw up the technical documentation referred to in Annex II and carry out
the relevant conformity assessment procedure referred to in Article 13 or have
it carried out.
Where compliance
of a product with the applicable requirements has been demonstrated by that
procedure, manufacturers shall draw up an EU declaration of conformity and
affix the CE marking and the specific marking of explosion protection.
3. Manufacturers
shall keep the technical documentation and the EU declaration of conformity for
at least 10 years after the product has been placed on the market.
4. Manufacturers
shall ensure that procedures are in place for series production to remain in
conformity. Changes in a product design or characteristics and changes in the
harmonised standards or in technical specifications by reference to which
conformity of a product is declared shall be adequately taken into account.
5. Manufacturers
shall ensure that their products bear a type, batch or serial number or other
element allowing their identification, or, where the size or nature of the
product does not allow it, that the required information is provided on the
packaging or in a document accompanying the product.
6. Manufacturers
shall indicate their name and the address at which they can be contacted on the
product or, where that is not possible, on its packaging or in a document
accompanying the product. The address must indicate a single point at which the
manufacturer can be contacted.
7. Manufacturers
shall ensure that the product is accompanied by instructions and safety
information in a language which can be easily understood by end-users, as
determined by the Member State concerned.
8. Manufacturers
who consider or have reason to believe that a product which they have placed on
the market is not in conformity with this Directive shall immediately take the
necessary corrective measures to bring that product into conformity, to
withdraw it or recall it, if appropriate. Furthermore, where the product presents
a risk, manufacturers shall immediately inform the competent national
authorities of the Member States in which they made the product available to
that effect, giving details, in particular, of the non-compliance and of any
corrective measures taken.
9. Manufacturers
shall, further to a reasoned request from a competent national authority,
provide it with all the information and documentation necessary to demonstrate
the conformity of the product, in a language which can be easily understood by
that authority. They shall cooperate with that authority, at its request, on
any action taken to eliminate the risks posed by products which they have
placed on the market.
Article 7
[Article R3 of Decision No 768/2008/EC]
Authorised
representatives
1. A manufacturer
may, by a written mandate, appoint an authorised representative.
The obligations
laid down in Article 6(1) and the drawing up of technical documentation shall
not form part of the authorised representative's mandate.
2. An authorised
representative shall perform the tasks specified in the mandate received from
the manufacturer. The mandate shall allow the authorised representative to do
at least the following:
(a)                   
keep the EU declaration
of conformity and the technical documentation at the disposal of national
surveillance authorities for at least 10 years after the product has been
placed on the market;
(b)                   
further to a reasoned
request from a competent national authority, provide that authority with all
the information and documentation necessary to demonstrate the conformity of a
product;
(c)                   
cooperate with the
competent national authorities, at their request, on any action taken to
eliminate the risks posed by products covered by the authorised
representative's mandate.
Article 8
[Article R4 of Decision No 768/2008/EC]
Obligations of
importers
1. Importers
shall place only compliant products on the Union market.
2. Before placing
a product on the market importers shall ensure that the appropriate conformity
assessment procedure has been carried out by the manufacturer. They shall
ensure that the manufacturer has drawn up the technical documentation, that the
product bears the CE marking and the specific marking of explosion protection and
is accompanied by the required documents, and that the manufacturer has
complied with the requirements set out in Article 6(5) and (6).
Where an importer
considers or has reason to believe that a product is not in conformity with the
essential health and safety requirements set out in Annex II, he shall not
place the product on the market until it has been brought into conformity.
Furthermore, where the product presents a risk, the importer shall inform the
manufacturer and the market surveillance authorities to that effect.
3. Importers
shall indicate their name and the address at which they can be contacted on the
product or, where that is not possible, on its packaging or in a document
accompanying the product.
4. Importers
shall ensure that the product is accompanied by instructions and safety
information in a language which can be easily understood by end-users, as
determined by the Member State concerned.
5. Importers shall
ensure that, while a product is under their responsibility, storage or
transport conditions do not jeopardise its compliance with the essential health
and safety requirements set out in Annex II.
6. Importers who
consider or have reason to believe that a product which they have placed on the
market is not in conformity with the requirements of this Directive shall immediately
take the corrective measures necessary to bring that product into conformity,
to withdraw it or recall it, if appropriate. Furthermore, where the product presents
a risk, importers shall immediately inform the competent national authorities
of the Member States in which they made the product available to that effect,
giving details, in particular, of the non-compliance and of any corrective
measures taken.
7. Importers
shall, for at least 10 years after the product has been placed on the market, keep
a copy of the EU declaration of conformity at the disposal of the market
surveillance authorities and ensure that the technical documentation can be
made available to those authorities, upon request.
8. Importers
shall, further to a reasoned request from a competent national authority,
provide it with all the information and documentation necessary to demonstrate
the conformity of a product in a language which can be easily understood by
that authority. They shall cooperate with that authority, at its request, on
any action taken to eliminate the risks posed by products which they have
placed on the market.
Article 9
[Article R5 of Decision No 768/2008/EC]
Obligations of
distributors
1. When making a
product available on the market distributors shall act with due care in
relation to the requirements of this Directive.
2. Before making
a product available on the market or putting it into service distributors shall
verify that the product bears the CE marking and the specific marking of
explosion protection, that it is accompanied by the required documents and by
instructions in a language which can be easily understood by end-users in the
Member State in which the product is to be made available on the market, and
that the manufacturer and the importer have complied with the requirements set
out in Article 6(5) and (6) and Article 8(3).
Where a
distributor considers or has reason to believe that a product is not in
conformity with the essential health and safety requirements set out in Annex II,
he shall not make the product available on the market until it has been brought
into conformity. Furthermore, where the product presents a risk, the
distributor shall inform the manufacturer or the importer to that effect as
well as the market surveillance authorities.
3. Distributors
shall ensure that, while a product is under their responsibility, storage or
transport conditions do not jeopardise its compliance with the essential health
and safety requirements set out in Annex II.
4. Distributors
who consider or have reason to believe that a product which they have made
available on the market is not in conformity with the requirements of this Directive
shall make sure that the corrective measures necessary to bring that product
into conformity, to withdraw it or recall it, if appropriate, are taken.
Furthermore, where the product presents a risk, distributors shall immediately
inform the competent national authorities of the Member States in which they
made the product available to that effect, giving details, in particular, of
the non-compliance and of any corrective measures taken.
5. Distributors
shall, further to a reasoned request from a competent national authority,
provide it with all the information and documentation necessary to demonstrate
the conformity of a product. They shall cooperate with that authority, at its
request, on any action taken to eliminate the risks posed by products which
they have made available on the market.
Article 10
[Article R6 of Decision No 768/2008/EC]
Cases in which
obligations of manufacturers apply to importers and distributors
An importer or
distributor shall be considered a manufacturer for the purposes of this
Directive and he shall be subject to the obligations of the manufacturer under
Article 6, where he places a product on the market under his name or trademark
or modifies a product already placed on the market in such a way that
compliance with the requirements of this Directive may be affected.
Article 11
[Article R7 of Decision No 768/2008/EC]
Identification
of economic operators
Economic
operators shall, on request, identify the following to the market surveillance
authorities, for at least 10 years after the product has been placed on the
market:
(a)                   
any economic operator
who has supplied them with a product;
(b)                   
any economic operator
to whom they have supplied a product.
Economic
operators shall be able to present the information referred to in the first paragraph
for a period of 10 years after they have been supplied with the product and for
a period of 10 years after they have supplied the product.
CHAPTER 3
Conformity of the product
Article 12 [Article
R8 of Decision No 768/2008/EC]
Presumption of
conformity
1. Products which
are in conformity with harmonised standards or parts thereof the references of
which have been published in the Official Journal of the European Union
shall be presumed to be in conformity with the essential health and safety requirements
covered by those standards or parts thereof, set out in Annex II.
[Where a
harmonised standard satisfies the requirements which it covers and which are
set out in Annex II or in Article 21, the Commission shall publish the
references of those standards in the Official Journal of the European Union.]
ê 94/9/EC
(adapted)
2. In the absence of harmonizsed standards, Member States shall take
any steps which they deem necessary to bring to the attention of the parties
concerned to the existing national technical standards and specifications
regarded as important or relevant to the proper implementation of the essential
health and safety requirements Ö set
out Õ in Annex II.
ê 94/9/EC
(adapted)
ð new
Article 813
Ö Conformity
assessment procedures Õ
1. The procedures Ö to be
followed Õ for assessing
the conformity of equipment,
including where necessary the devices referred to in Article 1 (2),
Ö products Õ shall be as
follows:
(a)          Ö for Õ equipment-group
I and II, equipment-category M 1 and 1 Ö ,
the Õ The manufacturer or his
authorized representative established in the Community must, in order to
affix the CE marking, follow the CE type-examination ð EU-type examination ï procedure (referred to in
Annex III), in conjunction with Ö either of
the following procedures Õ :
–              
the procedure relating to production quality assurance
ð Conformity to type based on quality
assurance of the production process ï (referred to in Annex IV),; or
–              
the procedure relating to product verification ð Conformity to type based on product
verification ï (referred to in Annex V);
(b)          Ö for Õ eEquipment-group I
and II, equipment-category M 2 and 2:
(i)      iIn
the case of internal combustion engines and electrical equipment in these
groups and categories, the manufacturer or his authorized representative established in the Community shall, in order to affix
the CE mark, follow the EC-type
examination ð EU-type examination ï procedure (referred to in
Annex III), in conjunction with Ö either of
the following procedures Õ :
–              
the procedure relating to conformity to type ð Conformity to type based on internal
production control plus supervised product testing ï referred to in Annex VI; or
–              
the procedure relating to product quality assurance
ð Conformity to type based on product
quality assurance ï referred to in Annex VII;
(ii)     in the case of other equipment in
these groups and categories, the manufacturer or his authorized representative established in the
Community must, in order to affix the CE mark, follow the
procedure relating to internal control of production
ð Internal production control ï (referred to in Annex VIII)
and
the communication of the dossier provided for
in Annex VIII, paragraph 32, to a notified body, which shall
acknowledge receipt of it as soon as possible and shall retain it.
(c)          Ö for Õ equipment-group
II, equipment-category 3 The manufacturer or his authorized representative established in the Community must, in order to affix
the CE marking, follow,
the procedure relating to internal control
of production ð Internal production control ï referred to in Annex
VIII;
(d)          Ö for Õ equipment-groups
I and II, iIn addition to the
procedures referred to in paragraph 1 Ö points Õ (a), (b) and
(c) Ö of this
paragraph Õ , 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 ð Conformity based on unit
verification ï (referred to in Annex IX)
Ö may also
be followed Õ .
2. The provisions of 1 Ö Procedure
referred to in points Õ (a) or 1(d) Ö of
paragraph 1 Õ above shall
be used for conformity assessment of autonomous protective systems.
ê 94/9/EC
(adapted)
è1 Corrigendum, OJ L 21, 26.1.2000, p. 42
ð new
3. The procedures referred to in paragraph
1 shall be applied in respect of components as referred to in Article 4
(2)5(2),
with the exception of the affixing of the CE marking. è1 A written attestation ð of conformity ï shall be issued by the manufacturer ç or his
authorized representative established in the Community Ö Union Õ, declaring the
conformity of the components with the provisions of this Directive
which apply to them
and stating their characteristics and how they must be incorporated into equipment or protective
systems Ö products Õ to assist
compliance with the essential Ö health
and safety Õ requirements
applicable to finished equipment or protective systems Ö products Õ .
ê 94/9/EC
(adapted)
ð new
4. In addition, the manufacturer or his authorized representative
established in the Community may, in order to affix
the CE marking, follow with regard to the safety aspects
referred to in point 1.2.7 of Annex II, the procedure relating to internal control of production
ð Internal production control ï referred to in Annex VIII Ö may be
followed Õ .
5. Notwithstanding the previous paragraphs
Ö By
derogation from paragraphs 1 to 4 Õ , the
competent authorities may, on a duly justified request, authorize the placing
on the market and putting into service on the territory of the Member State
concerned of the equipment,
protective systems and individual devices referred to in Article 1 (2)
Ö products Õ in respect of
which the procedures referred to in the previous paragraphs Ö 1 to 4 Õ have not been
applied and the use of which is in the interests of protection.
6. Documents and correspondence relating to
the procedures referred to in the abovementioned paragraphs Ö 1 to 4 Õ shall be drawn
up in one of the official
languages of the Member States in which those procedures are being applied or
in a language accepted by the notified body Ö a
language easily understood by end-users, as determined by the Member State
concerned Õ .
ê 94/9/EC
7.
(a)          Where the equipment, protective systems and devices
referred to in Article 1(2) are subject to other Community Directives covering
other aspects which also provide for the affixing of the CE marking referred to
in Article 10, that
marking shall indicate that the equipment, protective systems and devices
referred to in Article 1(2) are also presumed to conform with the provisions of
those other Directives.
(b)          However,
where one or more of those Directives allow the manufacturer, during a transitional period, to choose which
arrangements to apply, the CE marking shall indicate conformity only with the
Directives applied by the manufacturer. In this case, particulars of the said
Directives, as published in the Official Journal of the European Communities, must be given in the documents, notices or
instructions required by the Directives and accompanying the equipment, protective systems and
devices referred to in Article 1(2). 
ò new
Article 14
[Article R10 of Decision No 768/2008/EC]
EU declaration
of conformity
1. The EU declaration
of conformity shall state that the fulfilment of the essential health and
safety requirements set out in Annex II has been demonstrated.
2. The EU declaration
of conformity shall have the model structure set out in Annex III of Decision
No 768/2008/EC, shall contain the elements specified in the relevant conformity
assessment procedures set out in Annexes III to IX of this Directive and shall
be continuously updated. It shall be translated into the language or languages
required by the Member State in which market the product is made available.
3. Where a
product is subject to more than one Union act requiring an EU declaration of
conformity, a single EU declaration of conformity shall be drawn up in respect
of all such Union acts. That declaration shall contain the identification of
the acts concerned, including the publication references.
4. By drawing up
the EU declaration of conformity, the manufacturer shall assume the full
responsibility for the compliance of the product.
Article 15
[Article R11 of Decision No 768/2008/EC]
General
principles of the CE marking
The CE marking
shall be subject to the general principles set out in Article 30 of Regulation
(EC) No 765/2008.
Article 16
[Article R12 of Decision No 768/2008/EC]
Rules and
conditions for affixing the CE marking and the specific marking of explosion
protection
1. The CE marking
shall be affixed visibly, legibly and indelibly to the product or to its data
plate. Where that is not possible or not warranted on account of the nature of
the product, it shall be affixed to the packaging and to the accompanying
documents.
2. The CE marking
shall be affixed before the product is placed on the market. It shall be
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 number of the notified body, where that body is
involved in the production control phase.
The
identification number of the notified body shall be affixed by the body itself
or, under its instructions, by the manufacturer or his authorised
representative.
4. The CE
marking, the specific marking and the symbol referred to in paragraph 2 and,
where applicable, the identification number referred to in paragraph 3, may be
followed by a pictogram or any other mark indicating a special risk or use. 
5. Pictograms or
any other mark defined in this Directive may only be used together with the CE
marking.
6. 
ê 94/9/EC
(adapted)
Equipment and protective systems may be Ö Products that
are Õ designed for a
particular explosive atmosphere. In this case, they must Ö shall Õ be marked
accordingly.
ò new
CHAPTER 4
Notification of conformity
assessment bodies
Article 17
[Article R13 of Decision No 768/2008/EC]
Notification
Member States
shall notify the Commission and the other Member States of bodies authorised to
carry out third-party conformity assessment tasks under this Directive.
Article 18
[Article R14 of Decision No 768/2008/EC]
Notifying
authorities
1. Member States
shall designate a notifying authority that shall be responsible for setting up
and carrying out the necessary procedures for the assessment and notification
of conformity assessment bodies and the monitoring of notified bodies,
including compliance with the provisions of Article 23.
2. Member States
may decide that the assessment and monitoring referred to in paragraph 1 shall
be carried out by a national accreditation body within the meaning of and in
accordance with Regulation (EC) No 765/2008.
3. Where the
notifying authority delegates or otherwise entrusts the assessment,
notification or monitoring referred to in paragraph 1 to a body which is not a
governmental entity, that body shall be a legal entity and shall comply mutatis
mutandis with the requirements laid down in Article 19(1) to (6). In
addition it shall have arrangements to cover liabilities arising out of its
activities.
4. The notifying
authority shall take full responsibility for the tasks performed by the body
referred to in paragraph 3.
Article 19
[Article R15 of Decision No 768/2008/EC]
Requirements
relating to notifying authorities
1. A notifying
authority shall be established in such a way that no conflict of interest with
conformity assessment bodies occurs.
2. A notifying
authority shall be organised and operated so as to safeguard the objectivity
and impartiality of its activities.
3. A notifying
authority shall be organised in such a way that each decision relating to
notification of a conformity assessment body is taken by competent persons
different from those who carried out the assessment.
4. A notifying
authority shall not offer or provide any activities that conformity assessment
bodies perform or consultancy services on a commercial or competitive basis.
5. A notifying
authority shall safeguard the confidentiality of the information it obtains.
6. A notifying
authority shall have a sufficient number of competent personnel at its disposal
for the proper performance of its tasks.
Article 20
[Article R16 of Decision No 768/2008/EC]
Information
obligation on notifying authorities
Member States
shall inform the Commission of their procedures for the assessment and
notification of conformity assessment bodies and the monitoring of notified
bodies, and of any changes thereto.
The Commission
shall make that information publicly available.
Article 21
[Article R17 of Decision No 768/2008/EC]
Requirements
relating to notified bodies
1. For the
purposes of notification, a conformity assessment body shall meet the
requirements laid down in paragraphs 2 to 11.
2. A conformity
assessment body shall be established under national law and have legal
personality.
3. A conformity
assessment body shall be a third-party body independent of the organisation or
the product it assesses.
A body belonging
to a business association or professional federation representing undertakings
involved in the design, manufacturing, provision, assembly, use or maintenance
of products which it assesses, may, on condition that its independence and the
absence of any conflict of interest are demonstrated, be considered such a
body.
4. A conformity
assessment body, its top level management and the personnel responsible for
carrying out the conformity assessment tasks shall not be the designer,
manufacturer, supplier, installer, purchaser, owner, user or maintainer of the
products which they assess, nor the authorised representative of any of those
parties. This shall not preclude the use of assessed products that are
necessary for the operations of the conformity assessment body or the use of
such products for personal purposes.
A conformity
assessment body, its top level management and the personnel responsible for
carrying out the conformity assessment tasks shall not be directly involved in
the design, manufacture or construction, the marketing, installation, use or
maintenance of those products, or represent the parties engaged in those
activities. They shall not engage in any activity that may conflict with their
independence of judgement or integrity in relation to conformity assessment
activities for which they are notified. This shall in particular apply to
consultancy services.
Conformity
assessment bodies shall ensure that the activities of their subsidiaries or
subcontractors do not affect the confidentiality, objectivity or impartiality
of their conformity assessment activities.
5. Conformity
assessment bodies and their personnel shall carry out the conformity assessment
activities with the highest degree of professional integrity and the requisite
technical competence in the specific field and shall be free from all pressures
and inducements, particularly financial, which might influence their judgement
or the results of their conformity assessment activities, especially as regards
persons or groups of persons with an interest in the results of those
activities.
6. A conformity
assessment body shall be capable of carrying out all the conformity assessment
tasks assigned to it by Annexes III to IX and in relation to which it has been
notified, whether those tasks are carried out by the conformity assessment body
itself or on its behalf and under its responsibility.
At all times and
for each conformity assessment procedure and each kind or category of products
in relation to which it has been notified, a conformity assessment body shall
have at its disposal the necessary:
(a)                   
personnel with
technical knowledge and sufficient and appropriate experience to perform the
conformity assessment tasks;
(b)                   
descriptions of
procedures in accordance with which conformity assessment is carried out,
ensuring the transparency and the ability of reproduction of those procedures.
It shall have appropriate policies and procedures in place that distinguish
between tasks it carries out as a notified body and other activities;
(c)                   
procedures for the
performance of activities which take due account of the size of an undertaking,
the sector in which it operates, its structure, the degree of complexity of the
product technology in question and the mass or serial nature of the production
process.
It shall have the
means necessary to perform the technical and administrative tasks connected
with the conformity assessment activities in an appropriate manner and shall
have access to all necessary equipment or facilities.
7. The personnel
responsible for carrying out conformity assessment activities shall have the
following:
(a)                   
sound technical and
vocational training covering all the conformity assessment activities in
relation to which the conformity assessment body has been notified;
(b)                   
satisfactory knowledge
of the requirements of the assessments they carry out and adequate authority to
carry out those assessments;
(c)                   
appropriate knowledge
and understanding of the essential health and safety requirements set out in
Annex II, of the applicable harmonised standards and of the relevant provisions
of Union harmonisation legislation and of national legislation;
(d)                   
the ability to draw up
certificates, records and reports demonstrating that assessments have been
carried out.
8. The
impartiality of the conformity assessment bodies, their top level management and
of the assessment personnel shall be guaranteed.
The remuneration
of the top level management and assessment personnel of a conformity assessment
body shall not depend on the number of assessments carried out or on the
results of those assessments.
9. Conformity
assessment bodies shall take out liability insurance unless liability is
assumed by the State in accordance with national law, or the Member State
itself is directly responsible for the conformity assessment.
10. The personnel
of a conformity assessment body shall observe professional secrecy with regard
to all information obtained in carrying out their tasks under Annexes III to IX
or any provision of national law giving effect to it, except in relation to the
competent authorities of the Member State in which its activities are carried
out. Proprietary rights shall be protected.
11. Conformity
assessment bodies shall participate in, or ensure that their assessment
personnel are informed of, the relevant standardisation activities and the
activities of the notified body coordination group established under the
relevant Union harmonisation legislation and apply as general guidance the
administrative decisions and documents produced as a result of the work of that
group.
Article 22
[Article R18 of Decision No 768/2008/EC]
Presumption of
conformity
Where a
conformity assessment body demonstrates its conformity with the criteria laid
down in the relevant harmonised standards or parts thereof the references of
which have been published in the Official Journal of the European Union
it shall be presumed to comply with the requirements set out in Article 21 in
so far as the applicable harmonised standards cover those requirements.
Article 23
[Article R20 of Decision No 768/2008/EC]
Subsidiaries
of and subcontracting by notified bodies
1. Where a
notified body subcontracts specific tasks connected with conformity assessment
or has recourse to a subsidiary, it shall ensure that the subcontractor or the
subsidiary meets the requirements set out in Article 21 and shall inform the
notifying authority accordingly.
2. Notified
bodies shall take full responsibility for the tasks performed by subcontractors
or subsidiaries wherever these are established.
3. Activities may
be subcontracted or carried out by a subsidiary only with the agreement of the
client.
4. Notified
bodies shall keep at the disposal of the notifying authority the relevant
documents concerning the assessment of the qualifications of the subcontractor
or the subsidiary and the work carried out by them under Annexes III to IX.
Article 24
[Article R22 of Decision No 768/2008/EC]
Application
for notification
1. A conformity
assessment body shall submit an application for notification to the notifying
authority of the Member State in which it is established.
2. That
application shall be accompanied by a description of the conformity assessment
activities, the conformity assessment module or modules and the product or
products for which that body claims to be competent, as well as by an
accreditation certificate, where one exists, issued by a national accreditation
body attesting that the conformity assessment body fulfils the requirements
laid down in Article 21.
3. Where the
conformity assessment body concerned cannot provide an accreditation
certificate, it shall provide the notifying authority with all the documentary
evidence necessary for the verification, recognition and regular monitoring of
its compliance with the requirements laid down in Article 21.
Article 25
[Article R23 of Decision No 768/2008/EC]
Notification
procedure
1. Notifying
authorities may notify only conformity assessment bodies which have satisfied
the requirements laid down in Article 21.
2. They shall
notify the Commission and the other Member States using the electronic
notification tool developed and managed by the Commission.
3. The
notification shall include full details of the conformity assessment
activities, the conformity assessment module or modules and product or products
concerned and the relevant attestation of competence.
4. Where a
notification is not based on an accreditation certificate as referred to in
Article 24, the notifying authority shall provide the Commission and the other
Member States with documentary evidence which attests to the conformity
assessment body's competence and the arrangements in place to ensure that that
body will be monitored regularly and will continue to satisfy the requirements
laid down in Article 21.
5. The body
concerned may perform the activities of a notified body only where no
objections are raised by the Commission or the other Member States within two
weeks of a notification where an accreditation certificate is used or within
two months of a notification where accreditation is not used.
Only such a body
shall be considered a notified body for the purposes of this Directive.
6. The Commission
and the other Member States shall be notified of any subsequent relevant
changes to the notification.
Article 26
[Article R24 of Decision No 768/2008/EC]
Identification
numbers and lists of notified bodies
1. The Commission
shall assign an identification number to a notified body.
It shall assign a
single such number even where the body is notified under several Union acts.
2. The Commission
shall make publicly available the list of the bodies notified under this Directive,
including the identification numbers that have been allocated to them and the
activities for which they have been notified.
The Commission
shall ensure that that list is kept up to date.
Article 27 [Article
R25 of Decision No 768/2008/EC]
Changes to
notifications
1. Where a
notifying authority has ascertained or has been informed that a notified body
no longer meets the requirements laid down in Article 21, or that it is failing
to fulfil its obligations, the notifying authority shall restrict, suspend or
withdraw notification as appropriate, depending on the seriousness of the
failure to meet those requirements or fulfil those obligations. It shall
immediately inform the Commission and the other Member States accordingly.
2. In the event
of restriction, suspension or withdrawal of notification, or where the notified
body has ceased its activity, the notifying Member State shall take appropriate
steps to ensure that the files of that body are either processed by another
notified body or kept available for the responsible notifying and market
surveillance authorities at their request.
Article 28
[Article R26 of Decision No 768/2008/EC]
Challenge of
the competence of notified bodies
1. The Commission
shall investigate all cases where it doubts, or doubt is brought to its
attention regarding, the competence of a notified body or the continued
fulfilment by a notified body of the requirements and responsibilities to which
it is subject.
2. The notifying
Member State shall provide the Commission, on request, with all information
relating to the basis for the notification or the maintenance of the competence
of the body concerned.
3. The Commission
shall ensure that all sensitive information obtained in the course of its
investigations is treated confidentially.
4. Where the
Commission ascertains that a notified body does not meet or no longer meets the
requirements for its notification, it shall inform the notifying Member State
accordingly and request it to take the necessary corrective measures, including
de-notification if necessary.
Article 29
[Article R27 of Decision No 768/2008/EC]
Operational
obligations of notified bodies
1. Notified
bodies shall carry out conformity assessments in accordance with the conformity
assessment procedures provided for in Annexes III to IX.
2. Conformity
assessments shall be carried out in a proportionate manner, avoiding
unnecessary burdens for economic operators. Conformity assessment bodies shall
perform their activities taking due account of the size of an undertaking, the
sector in which it operates, its structure, the degree of complexity of the
product technology in question and the mass or serial nature of the production
process.
In so doing they
shall nevertheless respect the degree of rigour and the level of protection
required for the compliance of the product with the provisions of this
Directive.
3. Where a
notified body finds that the essential health and safety requirements set out
in Annex II or corresponding harmonised standards or technical specifications
have not been met by a manufacturer, it shall require that manufacturer to take
appropriate corrective measures and shall not issue a conformity certificate.
4. Where, in the
course of the monitoring of conformity following the issue of a certificate, a
notified body finds that a product no longer complies with the requirements
laid down in this Directive, it shall require the manufacturer to take
appropriate corrective measures and shall suspend or withdraw the certificate
if necessary.
5. Where
corrective measures are not taken or do not have the required effect, the
notified body shall restrict, suspend or withdraw any certificates, as
appropriate.
Article 30
Appeal against
decisions of notified bodies
Member States
shall ensure that an appeal procedure against decision of the notified bodies
is available.
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 conformity assessment activities;
(d)                   
on request, conformity
assessment activities performed within the scope of their notification and any
other activity performed, including cross-border activities and subcontracting.
2. Notified
bodies shall provide the other bodies notified under this Directive carrying
out similar conformity assessment activities covering the same products with
relevant information on issues relating to negative and, on request, positive
conformity assessment results.
Article 32
[Article R29 of Decision No 768/2008/EC]
Exchange of
experience
The Commission
shall provide for the organisation of exchange of experience between the Member
States' national authorities responsible for notification policy.
Article 33
[Article R30 of Decision No 768/2008/EC]
Coordination
of notified bodies
The Commission
shall ensure that appropriate coordination and cooperation between bodies
notified under this Directive are put in place and properly operated in the
form of a sectoral group of notified bodies.
Member States
shall ensure that the bodies notified by them participate in the work of that
group, directly or by means of designated representatives.
CHAPTER 5
Union market surveillance, control
of products entering the union market and safeguard procedures
Article 34
Union market
surveillance and control of products entering the Union market
Article 15(3) and
Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to products.
Article 35
[Article R31 of Decision No 768/2008/EC]
Procedure for
dealing with products presenting a risk at national level
1. Where the
market surveillance authorities of one Member State have taken action pursuant
to Article 20 of Regulation (EC) No 765/2008, or where they have sufficient
reason to believe that a product presents a risk to the health or safety of persons
or to other aspects of public interest protection laid down in this Directive, they
shall carry out an evaluation in relation to the product concerned covering all
the requirements laid down in this Directive. The relevant economic operators
shall cooperate as necessary with the market surveillance authorities.
Where, in the
course of that evaluation, the market surveillance authorities find that the
product does not comply with the requirements laid down in this Directive, they
shall without delay require the relevant economic operator to take all
appropriate corrective action to bring the product into compliance with those
requirements, to withdraw the product from the market, or to recall it within a
reasonable period, commensurate with the nature of the risk, as they may
prescribe.
The market
surveillance authorities shall inform the relevant notified body accordingly.
Article 21 of
Regulation (EC) No 765/2008 shall apply to the measures referred to in the
second subparagraph.
2. Where the
market surveillance authorities consider that non-compliance is not restricted
to their national territory, they shall inform the Commission and the other
Member States of the results of the evaluation and of the actions which they
have required the economic operator to take.
3. The economic
operator shall ensure that all appropriate corrective action is taken in
respect of all the products concerned that it has made available on the market
throughout the Union.
4. Where the
relevant economic operator does not take adequate corrective action within the
period referred to in the second subparagraph of paragraph 1, the market
surveillance authorities shall take all appropriate provisional measures to
prohibit or restrict the being made available on their national market, to
withdraw the product from that market or to recall it.
The market
surveillance authorities shall inform the Commission and the other Member
States, without delay, of those measures.
5. The
information referred to in paragraph 4 shall include all available details, in
particular the data necessary for the identification of the non-compliant
product, the origin of the product, the nature of the non-compliance alleged
and the risk involved, the nature and duration of the national measures taken
and the arguments put forward by the relevant economic operator. In particular,
the market surveillance authorities shall indicate whether the non-compliance
is due to any of the following:
(a)                   
failure of the product
to meet requirements relating to the health or safety of persons or to other
aspects of public interest protection laid down in this Directive;
(b)                   
shortcomings in the
harmonised standards referred to in Annex II conferring a presumption of
conformity.
6. Member States
other than the Member State initiating the procedure shall without delay inform
the Commission and the other Member States of any measures adopted and of any
additional information at their disposal relating to the non-compliance of the product
concerned, and, in the event of disagreement with the notified national
measure, of their objections.
7. Where, within
2 months of receipt of the information referred to in paragraph 4, no objection
has been raised by either a Member State or the Commission in respect of a
provisional measure taken by a Member State, that measure shall be deemed
justified.
8. Member States
shall ensure that appropriate restrictive measures are taken in respect of the product
concerned without delay.
Article 36
[Article R32 of Decision No 768/2008/EC]
Union safeguard
procedure
1. Where, on
completion of the procedure set out in Article 35(3) and (4), objections are
raised against a measure taken by a Member State, or where the Commission
considers a national measure to be contrary to Union legislation, the
Commission shall without delay enter into consultation with the Member States
and the relevant economic operator or operators and shall evaluate the national
measure. On the basis of the results of that evaluation, the Commission shall
decide whether the national measure is justified or not.
The Commission
shall address its decision to all Member States and shall immediately
communicate it to them and the relevant economic operator or operators.
2. If the
national measure is considered justified, all Member States shall take the
measures necessary to ensure that the non-compliant product is withdrawn from
their market, and shall inform the Commission accordingly. If the national
measure is considered unjustified, the Member State concerned shall withdraw
the measure.
3. Where the
national measure is considered justified and the non-compliance of the product
is attributed to shortcomings in the harmonised standards referred to in
Article 35(5)(b) of this Directive, the Commission shall apply the procedure
provided for in Article 8 of Regulation (EU) No [../..] [on European
Standardisation].
Article 37
[Article R33 of Decision No 768/2008/EC]
Compliant
products which present a risk to health and safety
1. Where, having
performed an evaluation under Article 35(1), a Member State finds that although
a product is in compliance with this Directive, it presents a risk to the
health or safety of persons or to other aspects of public interest protection laid
down in this Directive, it shall require the relevant economic operator to take
all appropriate measures to ensure that the product concerned, when placed on
the market, no longer presents that risk, to withdraw the product from the
market or to recall it within a reasonable period, commensurate with the nature
of the risk, as it may prescribe.
2. The economic
operator shall ensure that corrective action is taken in respect of all the
products concerned that he has made available on the market throughout the
Union.
3. The Member
State shall immediately inform the Commission and the other Member States. That
information shall include all available details, in particular the data
necessary for the identification of the product concerned, the origin and the
supply chain of the product, the nature of the risk involved and the nature and
duration of the national measures taken.
4. The Commission
shall without delay enter into consultation with the Member States and the
relevant economic operator or operators and shall evaluate the national
measures taken. On the basis of the results of that evaluation, the Commission
shall decide whether the measure is justified or not, and where necessary,
propose appropriate measures.
5. The Commission
shall address its decision to all Member States and shall immediately
communicate it to them and the relevant economic operator or operators.
Article 38
[Article R34 of Decision No 768/2008/EC]
Formal
non-compliance
1. Without
prejudice to Article 35, where a Member State makes one of the following
findings, it shall require the relevant economic operator to put an end to the
non-compliance concerned:
(a)                   
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;
(e)                   
technical
documentation is either not available or not complete.
2. Where the
non-compliance referred to in paragraph 1 persists, the Member State concerned
shall take all appropriate measures to restrict or prohibit the product being
made available on the market or ensure that it is recalled or withdrawn from
the market.
ê 94/9/EC
Article 9
1. Member States
shall notify the Commission and the other Member States of the bodies which
they have appointed to carry out the procedures referred to in Article 8,
together with the specific tasks which these bodies have been appointed to
carry out and the identification numbers assigned to them beforehand by the
Commission.
The Commission
shall publish in the Official
Journal of the European Communities a list of the notified bodies, with their
identification numbers and the tasks for which they have been notified. The
Commission shall ensure that this list is kept up to date.
2. Member States
shall apply the criteria laid down in Annex XI in assessing the bodies to be
indicated in such notification. Bodies meeting the assessment criteria laid
down in the relative harmonized standards shall be presumed to fulfil those
criteria.
3. A Member State
which has approved a body must withdraw its notification if it finds that the
body no longer meets the criteria referred to in Annex XI. It shall immediately
inform the Commission and the other Member States accordingly.
CHAPTER III
CE conformity marking
Article 10
1. The CE
conformity marking shall consist of the initials «CE'». The form of the marking
to be used is shown in Annex X. The CE marking shall be followed by the
identification number of the notified body where such body is involved in the
production control stage.
2. The CE marking
shall be affixed distinctly,
visibly, legibly and indelibly
to equipment, protective systems and devices referred to in Article 1(2), supplementary to the provisions of point 1.0.5. of
Annex II.
3. The affixing of markings on the equipment, protective systems or
devices referred to in Article 1(2) which are likely to deceive third parties as to the
meaning and form of the CE marking shall be prohibited. Any other marking may be affixed to the equipment, protective systems or devices
referred to in Article 1(2), provided that the visibility and legibility of the
CE marking is not thereby reduced.
Article 11
Without prejudice
to Article 7:
(a)          where
a Member State establishes that the CE marking has been incorrectly affixed,
the manufacturer or his authorized representative established within the
Community shall be
obliged to bring the product into conformity as regards the provisions concerning the CE
marking and to end the infringement under the conditions imposed by the Member
State;
(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 withdrawn from the market in accordance with the procedures laid
down in Article 7.
CHAPTER IV6
ê 94/9/EC
(adapted)
Ö transitional
and Õ final
provisions
ê 94/9/EC
Article 12
Any decision taken
pursuant to this Directive which restricts or prohibits the placing on the
market and/or the putting into service or requires the withdrawal from the
market of equipment, a protective system, or a device referred to in Article
1 (2) shall state the exact grounds on which it is based. Such a decision shall
be notified forthwith to the party concerned, who shall at the same time be
informed of the legal remedies available to him under the laws in force in the Member State concerned and of the time limits
to which such remedies are subject.
Article 13
Member States
shall ensure that all the parties involved in the application of the Directive
are bound to observe confidentiality in respect of all information obtained
in the performance of carrying out their tasks. This does not affect the
obligations of the Member States and of the notified bodies regarding
reciprocal information and the dissemination of warnings.
ò new
Article 39
Penalties
Member States
shall lay down rules on penalties applicable to infringements of the national
provisions adopted pursuant to this Directive and shall take all measures
necessary to ensure that they are enforced.
The penalties
provided for shall be effective, proportionate and dissuasive.
Member States
shall notify those provisions to the Commission by [the date set out in the second
subparagraph of Article 40(1)] and shall notify it without delay of any
subsequent amendment affecting them.
ê 94/9/EC
(adapted)
ð new
Article 1440
Ö Transitional
provisions Õ
1. Directive 76/117/EEC, Directive 79/196/EEC[17] and Directive 82/130/EEC shall be
repealed as from 1 July 2003.
ð 1. Member States shall not impede the
making available on the market or the putting into service of products covered
by Directive 94/9/EC which are in conformity with that Directive and which were
placed on the market before [the date set out in the second subparagraph of
Article 41(1)]. ï
2. EC Certificates of conformity to the harmonised
standards obtained in accordance with the procedures laid down in the Directives referred to
in paragraph 1 Ö issued
pursuant to Article 8 of Directive 94/9/EC Õ shall continue to
be valid Ö under
this Directive Õ until 30 June 2003 unless they expire before that date. Their
validity shall continue to be limited to the harmonised standards indicated in
the aforementioned Directives.
3. Member States shall take the necessary action Ö measures Õ to ensure that
the notified bodies which are responsible pursuant to Article 8
(1) to (4)13(1) to (4)
for the assessment of the conformity of electrical equipment Ö products Õ placed on the
market before 1 July 2003 ð [Date] ï take account of the results of tests and verifications already
carried out under the Directives referred to in paragraph 1 Ö 94/9/EC Õ .
ê 94/9/EC
(adapted)
ð new
Article 1541
Ö Transposition Õ
1. Member States shall adopt and publish Ö by Õ ð [insert date: 2 years after adoption] ï Ö at the
latest Õ the laws,
regulations and administrative provisions necessary to comply with this Directive
Ö Article 2(2)
and (10) to (26), Article 3, Articles 5 to 40 and Annexes III to IX Õ before 1 September 1995.
They shall forthwith inform Ö communicate
to Õ the Commission
thereof
Ö the text
of those provisions and a correlation table between those provisions and this
Directive Õ .
The Member States Ö They Õ shall apply these measures
Ö those
provisions Õ with effect from 1 March
1996 Ö from [day
after the date mentioned in first subparagraph] Õ.
When Member States adopt the measures referred to
in the first subparagraph Ö those
provisions Õ, they shall
contain a reference to this Directive or shall be accompanied by such Ö a Õ reference at the time
Ö on the
occasion Õ of their
official publication. Ö 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. Õ The methods of making
such reference shall be laid down by Member States Ö shall
determine how such reference is to be made and how that statement is to be
formulated Õ .
ê 94/9/EC
2. However, Member
States shall allow the placing on the market and the putting into service of
equipment and protective systems conforming with the national regulations in
force in their territory at the date of adoption of this Directive for the
period until 30 June 2003.
ò new
2. Member States
shall communicate to the Commission the text of the main provisions of national
law which they adopt in the field covered by this Directive.
ê 
Article 42
Repeal
Directive 94/9/EC, as amended by the Regulation
listed in Annex X, Part A, is repealed with effect from [the date set out in
the second subparagraph of Article 41(1)], without prejudice to the obligations
of the Member States relating to the time-limits for transposition into
national law and application of the Directive 94/9/EC set out in Annex X, part
B.
References to the repealed Directive shall
be construed as references to this Directive and shall be read in accordance
with the correlation table in Annex XI.
Article 43
Entry into force
This Directive shall enter into force on
the twentieth day following that of its publication in the Official Journal
of the European Union.
Article 1, Articles 2(1) and (3) to (9), Article
4, Articles 41 to 44 and Annexes I, II, X and XI shall apply from [the date set
out in the second subparagraph of Article 41(1)].
ê 94/9/EC
(adapted)
Article 1644
Ö Addresses Õ
This Directive
is addressed to the Member States.
Done at […],
For the European Parliament                       For
the Council 
The
President                                                 The President 
ê 94/9/EC
ANNEX I
CRITERIA DETERMINING THE
CLASSIFICATION OF EQUIPMENT-GROUPS INTO CATEGORIES
1.
Equipment-group I
(a)          Category M 1 comprises equipment
designed and, where necessary, equipped with additional special means of
protection to be capable of functioning in conformity with the operational
parameters established by the manufacturer and ensuring a very high level of protection.
              Equipment in this category is
intended for use in underground parts of mines as well as those parts of
surface installations of such mines endangered by firedamp and/or combustible
dust.
              Equipment in this category is
required to remain functional, even in the event of rare incidents relating to
equipment, with an explosive atmosphere present, and is characterized by means
of protection such that:
–              
either, in the event of failure of one means of
protection, at least an independent second means provides the requisite level
of protection,
–              
or the requisite level of protection is assured
in the event of two faults occurring independently of each other.
              Equipment in this category must
comply with the supplementary requirements referred to in Annex II, 2.0.1.
(b)          Category M 2 comprises equipment
designed to be capable of functioning in conformity with the operational
parameters established by the manufacturer and ensuring a high level of
protection.
              Equipment in this category is
intended for use in underground parts of mines as well as those parts of
surface installations of such mines likely to be endangered by firedamp and/or
combustible dust.
              This equipment is intended to be
de-energized in the event of an explosive atmosphere.
              The means of protection relating
to equipment in this category assure the requisite level of protection during
normal operation and also in the case of more severe operating conditions, in
particular those arising from rough handling and changing environmental
conditions.
              Equipment in this category must
comply with the supplementary requirements referred to in Annex II, 2.0.2.
2.
Equipment-group II
(a)          Category 1 comprises equipment
designed to be capable of functioning in conformity with the operational
parameters established by the manufacturer and ensuring a very high level of
protection.
              Equipment in this category is
intended for use in areas in which explosive atmospheres caused by mixtures of
air and gases, vapours or mists or by air/dust mixtures are present
continuously, for long periods or frequently.
              Equipment in this category must
ensure the requisite level of protection, even in the event of rare incidents
relating to equipment, and is characterized by means of protection such that:
–              
either, in the event of failure of one means of
protection, at least an independent second means provides the requisite level
of protection,
–              
or the requisite level of protection is assured
in the event of two faults occurring independently of each other.
              Equipment in this category must
comply with the supplementary requirements referred to in Annex II, 2.1.
(b)          Category 2 comprises equipment
designed to be capable of functioning in conformity with the operational
parameters established by the manufacturer and of ensuring a high level of protection.
ê 94/9/EC
è1 Corrigendum, OJ L 21, 26.1.2000, p. 42
              Equipment in this category is
intended for use in areas in which explosive atmospheres caused by gases,
vapours, mists or air/dust mixtures è1 are likely to occur occasionally. ç
ê 94/9/EC
              The means of protection relating
to equipment in this category ensure the requisite level of protection, even in
the event of frequently occurring disturbances or equipment faults which normally
have to be taken into account.
              Equipment in this category must
comply with the supplementary requirements referred to in Annex II, 2.2.
(c)          Category 3 comprises equipment
designed to be capable of functioning in conformity with the operating parameters
established by the manufacturer and ensuring a normal level of protection.
              Equipment in this category is
intended for use in areas in which explosive atmospheres caused by gases,
vapours, mists, or air/dust mixtures are unlikely to occur or, if they do
occur, are likely to do so only infrequently and for a short period only.
              Equipment in this category
ensures the requisite level of protection during normal operation.
              Equipment in this category must
comply with the supplementary requirements referred to in Annex II, 2.3.
ê 94/9/EC
ANNEX II
ESSENTIAL HEALTH AND SAFETY
REQUIREMENTS RELATING TO THE DESIGN AND CONSTRUCTION OF EQUIPMENT AND
PROTECTIVE SYSTEMS INTENDED FOR USE IN POTENTIALLY EXPLOSIVE ATMOSPHERES
Preliminary observations
A. Technological knowledge, which can
change rapidly, must be taken into account as far as possible and be utilized
immediately.
ê 94/9/EC
(adapted)
B. For the devices referred to in Article 1 (2) Ö 1(1)(b) Õ , the essential
Ö health
and safety Õ requirements
shall apply only in so far as they are necessary for the safe and reliable
functioning and operation of those devices with respect to the risks of
explosion.
ê 94/9/EC
1. COMMON REQUIREMENTS FOR EQUIPMENT 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 manufacturer must
take measures:
–                        
above all, if possible, to prevent the formation
of explosive atmospheres which may be produced or released by equipment and by
protective systems themselves,
–                        
to prevent the ignition of explosive
atmospheres, taking into account the nature of every electrical and
non-electrical source of ignition,
–                        
should an explosion nevertheless occur which
could directly or indirectly endanger persons and, as the case may be, domestic
animals or property, to halt it immediately and/or to limit the range of
explosion flames and explosion pressures to a sufficient level of safety.
1.0.2. Equipment and protective systems
must be designed and manufactured after due analysis of possible operating
faults in order as far as possible to preclude dangerous situations.
Any misuse which can reasonably be
anticipated must be taken into account.
1.0.3. Special checking and
maintenance conditions
Equipment and protective systems subject to
special checking and maintenance conditions must be designed and constructed
with such conditions in mind.
1.0.4. Surrounding area conditions
Equipment and protective systems must be so
designed and constructed as to be capable of coping with actual or foreseeable
surrounding area conditions.
1.0.5. Marking
All equipment and protective systems must
be marked legibly and indelibly with the following minimum particulars:
–                        
name and address of the manufacturer,
ê 94/9/EC
(adapted)
–                        
CE marking (see Annex X, point A Ö II to Regulation
(EC) No 765/2008 Õ ),
ê 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'
(concerning explosive atmospheres caused by gases, vapours or mists),
              and/or
              the letter 'D' (concerning
explosive atmospheres caused by dust).
Furthermore, where necessary, they must
also be marked with all information essential to their safe use.
1.0.6. Instructions
(a)          All equipment and protective
systems must be accompanied by instructions, including at least the following
particulars:
–              
a recapitulation of the information with which
the equipment or protective system is marked, except for the serial number (see
1.0.5.), together with any appropriate additional information to facilitate
maintenance (e.g. address of the importer, repairer, etc.);
–              
instructions for safe:
–              
putting into service,
–              
use,
–              
assembling and dismantling,
–              
maintenance (servicing and emergency repair),
–              
installation,
–              
adjustment;
–              
where necessary, an indication of the danger
areas in front of pressure-relief devices;
–              
where necessary, training instructions;
–              
details which allow a decision to be taken
beyond any doubt as to whether an item of equipment in a specific category or a
protective system can be used safely in the intended area under the expected
operating conditions;
–              
electrical and pressure parameters, maximum
surface temperatures and other limit values;
–              
where necessary, special conditions of use,
including particulars of possible misuse which experience has shown might
occur;
–              
where necessary, the essential characteristics
of tools which may be fitted to the equipment or protective system.
ê 94/9/EC
(adapted)
(b)          The instructions must be drawn up
in one of the
Community languages Ö a
language easily understood by end-users, as determined by the Member State
concerned, Õ by the manufacturer
or his authorized representative established in the Community Ö Union Õ .
              On being put into service, all
equipment and protective systems must be accompanied by a translation of the
instructions in the language or languages of the country in which the equipment
or protective system is to be used and by the instructions in the original
language.
              This translation must be made by
either the manufacturer or his authorized representative established in the Community
Ö Union Õ or the person
introducing the equipment or protective system into the language area in
question.
              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
Ö Union Õ may be drawn
up in a single Community
Ö Union Õ language
understood by that personnel.
ê 94/9/EC
(c)          The instructions must contain the
drawings and diagrams necessary for the putting into service, maintenance,
inspection, checking of correct operation and, where appropriate, repair of the
equipment or protective system, together with all useful instructions, in
particular with regard to safety.
(d)          Literature describing the
equipment or protective system must not contradict the instructions with regard
to safety aspects.
1.1.
Selection of materials
1.1.1. The materials used for the
construction of equipment and protective systems must not trigger off an
explosion, taking into account foreseeable operational stresses.
1.1.2. Within the limits of the operating
conditions laid down by the manufacturer, it must not be possible for a
reaction to take place between the materials used and the constituents of the
potentially explosive atmosphere which could impair explosion protection.
ê 94/9/EC
è1 Corrigendum, OJ L 21, 26.1.2000, p. 42
1.1.3. Materials must be so selected that
predictable changes in their characteristics and their compatibility in
combination with other materials will not lead to a reduction in the protection
afforded; in particular, due account must be taken of the material's corrosion
and wear resistance, è1 electrical conductivity, mechanical strength,
ageing resistance ç and the
effects of temperature variations.
ê 94/9/EC
1.2.
Design and Construction
1.2.1. Equipment and protective systems
must be designed and constructed with due regard to technological knowledge of
explosion protection so that they can be safely operated throughout their
foreseeable lifetime.
1.2.2. Components to be incorporated into
or used as replacements in equipment and protective systems must be so designed
and constructed that they function safely for their intended purpose of
explosion protection when they are installed in accordance with the
manufacturer's instructions.
1.2.3. Enclosed structures and
prevention of leaks
Equipment which may release flammable gases
or dusts must wherever possible employ enclosed structures only.
ê 94/9/EC
è1 Corrigendum, OJ L 21, 26.1.2000, p. 42
If equipment contains openings or non-tight
joints, these must as far as possible be designed in è1 such a way that releases of gases or dusts ç 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 è1 so as to limit releases of flammable materials ç during filling
or draining.
ê 94/9/EC
1.2.4. Dust deposits
Equipment and protective systems which are
intended to be used in areas exposed to dust must be so designed that deposit
dust on their surfaces is not ignited.
In general, dust deposits must be limited
where possible. Equipment and protective systems must be easily cleanable.
The surface temperatures of equipment parts
must be kept well below the glow temperature of the deposit dust.
The thickness of deposit dust must be taken
into consideration and, if appropriate, means must be taken to limit the
temperature in order to prevent a heat build up.
1.2.5. Additional means of
protection
Equipment and protective systems which may
be exposed to certain types of external stresses must be equipped, where
necessary, with additional means of protection.
Equipment must withstand relevant stresses,
without adverse effect on explosion protection.
1.2.6. Safe opening
If equipment and protective systems are in
a housing or a locked container forming part of the explosion protection
itself, it must be possible to open such housing or container only with a
special tool or by means of appropriate protection measures.
1.2.7. Protection against other
hazards
Equipment and protective systems must be so
designed and manufactured as to:
(a)          avoid physical injury or other
harm which might be caused by direct or indirect contact;
(b)          assure that surface temperatures
of accessible parts or radiation which would cause a danger, are not produced;
(c)          eliminate non-electrical dangers
which are revealed by experience;
ê 94/9/EC
è1 Corrigendum, OJ L 21, 26.1.2000, p. 42
(d)          assure that è1 foreseeable conditions of overload do not give
rise ç to dangerous
situations.
ê 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
Ö Union Õ Directives,
this Directive shall not apply or shall cease to apply in the case of such
equipment and protective systems and of such risks upon application of those
specific Directives.
ê 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
atmosphere are placed in an enclosure, measures must be taken to ensure that
the enclosure withstands the pressure developed during an internal explosion of
an explosive mixture and prevents the transmission of the explosion to the
explosive atmosphere surrounding the enclosure.
1.3.
Potential ignition sources
1.3.1. Hazards arising from
different ignition sources
Potential ignition sources such as sparks,
flames, electric arcs, high surface temperatures, acoustic energy, optical
radiation, electromagnetic waves and other ignition sources must not occur.
1.3.2. Hazards arising from static
electricity
Electrostatic charges capable of resulting
in dangerous discharges must be prevented by means of appropriate measures.
1.3.3. Hazards arising from stray
electric and leakage currents
Stray electric and leakage currents in
conductive equipment parts which could result in, for example, the occurrence
of dangerous corrosion, overheating of surfaces or sparks capable of provoking
an ignition must be prevented.
1.3.4. Hazards arising from
overheating
Overheating caused by friction or impacts
occurring, for example, between materials and parts in contact with each other
while rotating or through the intrusion of foreign bodies must, as far as
possible, be prevented at the design stage.
1.3.5. Hazards arising from
pressure compensation operations
Equipment and protective systems must be so
designed or fitted with integrated measuring, control and regulation devices
that pressure compensations arising from them do not generate shock waves or
compressions which may cause ignition.
1.4.
Hazards arising from external effects
1.4.1. Equipment and protective systems
must be so designed and constructed as to be capable of performing their
intended function in full safety, even in changing environmental conditions and
in the presence of extraneous voltages, humidity, vibrations, contamination and
other external effects, taking into account the limits of the operating
conditions established by the manufacturer.
1.4.2. Equipment parts used must be
appropriate to the intended mechanical and thermal stresses and capable of
withstanding attack by existing or foreseeable aggressive substances.
1.5.
Requirements in respect of safety-related devices
ê 94/9/EC
è1 Corrigendum, OJ L 21, 26.1.2000, p. 42
1.5.1. Safety devices must function è1 independently of any measurement and/or control
devices ç required for
operation.
As far as possible, failure of a safety
device must be detected sufficiently rapidly by appropriate technical means to
ensure that there is only very little likelihood that dangerous situations will
occur.
è1 The fail-safe principle ç is to be
applied in general.
ê 94/9/EC
Safety-related switching must in general
directly actuate the relevant control devices without intermediate software
command.
1.5.2. In the event of a safety device
failure, equipment and/or protective systems shall, wherever possible, be
secured.
1.5.3. Emergency stop controls of safety
devices must, as far as possible, be fitted with restart lockouts. A new start
command may take effect on normal operation only after the restart lockouts
have been intentionally reset.
1.5.4. Control and display units
Where control and display units are used,
they must be designed in accordance with ergonomic principles in order to
achieve the highest possible level of operating safety with regard to the risk
of explosion.
1.5.5. Requirements in respect of
devices with a measuring function for explosion protection
In so far as they relate to equipment used
in explosive atmospheres, devices with a measuring function must be designed
and constructed so that they can cope with foreseeable operating requirements
and special conditions of use.
1.5.6. Where necessary, it must be possible
to check the reading accuracy and serviceability of devices with a measuring
function.
1.5.7. The design of devices with a
measuring function must incorporate a safety factor which ensures that the
alarm threshold lies far enough outside the explosion and/or ignition limits of
the atmospheres to be registered, taking into account, in particular, the
operating conditions of the installation and possible aberrations in the
measuring system.
1.5.8. Risks arising from software
In the design of software-controlled
equipment, protective systems and safety devices, special account must be taken
of the risks arising from faults in the programme.
1.6. Integration
of safety requirements relating to the system
1.6.1. Manual override must be possible in
order to shut down the equipment and protective systems incorporated within
automatic processes which deviate from the intended operating conditions,
provided that this does not compromise safety.
1.6.2. When the emergency shutdown system
is actuated, accumulated energy must be dispersed as quickly and as safely as
possible or isolated so that it no longer constitutes a hazard.
This does not apply to
electrochemically-stored energy.
1.6.3. Hazards arising from power
failure
Where equipment and protective systems can
give rise to a spread of additional risks in the event of a power failure, it
must be possible to maintain them in a safe state of operation independently of
the rest of the installation.
1.6.4. Hazards arising from
connections
Equipment and protective systems must be
fitted with suitable cable and conduit entries.
When equipment and protective systems are
intended for use in combination with other equipment and protective systems,
the interface must be safe.
1.6.5. Placing of warning devices
as parts of equipment
Where equipment or protective systems are
fitted with detection or alarm devices for monitoring the occurrence of
explosive atmospheres, the necessary instructions must be provided to enable
them to be provided at the appropriate places.
2. SUPPLEMENTARY REQUIREMENTS IN RESPECT
OF EQUIPMENT
2.0. Requirements
applicable to equipment in category M of equipment-group I
2.0.1. Requirements applicable to
equipment in category M 1 of equipment-group I
2.0.1.1. Equipment must be so designed and
constructed that sources of ignition do not become active, even in the event of
rare incidents relating to equipment.
Equipment must be equipped with means of
protection such that:
–                        
either, in the event of failure of one means of
protection, at least an independent second means provides the requisite level
of protection,
–                        
or, the requisite level of protection is ensured
in the event of two faults occurring independently of each other.
Where necessary, this equipment must be
equipped with additional special means of protection.
It must remain functional with an explosive
atmosphere present.
2.0.1.2. Where necessary, equipment must be
so constructed that no dust can penetrate it.
2.0.1.3. The surface temperatures of
equipment parts must be kept clearly below the ignition temperature of the
foreseeable air/dust mixtures in order to prevent the ignition of suspended
dust.
2.0.1.4. Equipment must be so designed that
the opening of equipment parts which may be sources of ignition is possible
only under non-active or intrinsically safe conditions. Where it is not
possible to render equipment non-active, the manufacturer must affix a warning
label to the opening part of the equipment.
If necessary, equipment must be fitted with
appropriate additional interlocking systems.
2.0.2. Requirements applicable to
equipment in category M 2 of equipment-group I
2.0.2.1. Equipment must be equipped with
means of protection ensuring that sources of ignition do not become active
during normal operation, even under more severe operating conditions, in
particular those arising from rough handling and changing environmental
conditions.
The equipment is intended to be
de-energized in the event of an explosive atmosphere.
2.0.2.2. Equipment must be so designed that
the opening of equipment parts which may be sources of ignition is possible
only under non-active conditions or via appropriate interlocking systems. Where
it is not possible to render equipment non-active, the manufacturer must affix
a warning label to the opening part of the equipment.
2.0.2.3. The requirements regarding
explosion hazards arising from dust applicable to category M 1 must be applied.
2.1. Requirements
applicable to equipment in category 1 of equipment-group II
ê 94/9/EC
è1 Corrigendum, OJ L 21, 26.1.2000, p. 42
2.1.1. è1 Explosive atmospheres caused by gases, vapours
or mists ç
ê 94/9/EC
2.1.1.1. Equipment must be so designed and
constructed that sources of ignition do not become active, even in event of
rare incidents relating to equipment.
It must be equipped with means of
protection such that:
–                        
either, in the event of failure of one means of
protection, at least an independent second means provides the requisite level
of protection,
–                        
or, the requisite level of protection is ensured
in the event of two faults occurring independently of each other.
2.1.1.2. For equipment with surfaces which
may heat up, measures must be taken to ensure that the stated maximum surface
temperatures are not exceeded even in the most unfavourable circumstances.
Temperature rises caused by heat build-ups
and chemical reactions must also be taken into account.
2.1.1.3. Equipment must be so designed that
the opening of equipment parts which might be sources of ignition is possible
only under non-active or intrinsically safe conditions. Where it is not
possible to render equipment non-active, the manufacturer must affix a warning
label to the opening part of the equipment.
If necessary, equipment must be fitted with
appropriate additional interlocking systems.
2.1.2. Explosive atmospheres caused
by air/dust mixtures
2.1.2.1. Equipment must be so designed and
constructed that ignition of air/dust mixtures does not occur even in the event
of rare incidents relating to equipment.
It must be equipped with means of
protection such that
–                        
either, in the event of failure of one means of
protection, at least an independent second means provides the requisite level
of protection,
–                        
or, the requisite level of protection is ensured
in the event of two faults occurring independently of each other.
2.1.2.2. Where necessary, equipment must be
so designed that dust can enter or escape from the equipment only at
specifically designated points.
This requirement must also be met by cable
entries and connecting pieces.
2.1.2.3. The surface temperatures of equipment
parts must be kept well below the ignition temperature of the foreseeable
air/dust mixtures in order to prevent the ignition of suspended dust.
2.1.2.4. With regard to the safe opening of
equipment parts, requirement 2.1.1.3 applies.
2.2. Requirements
for category 2 of equipment-group II
2.2.1. Explosive atmospheres caused
by gases, vapours or mists
2.2.1.1. Equipment must be so designed and
constructed as to prevent ignition sources arising, even in the event of
frequently occurring disturbances or equipment operating faults, which normally
have to be taken into account.
2.2.1.2. Equipment parts must be so
designed and constructed that their stated surface temperatures are not
exceeded, even in the case of risks arising from abnormal situations anticipated
by the manufacturer.
2.2.1.3. Equipment must be so designed that
the opening of equipment parts which might be sources of ignition is possible
only under non-active conditions or via appropriate interlocking systems. Where
it is not possible to render equipment non-active, the manufacturer must affix
a warning label to the opening part of the equipment.
2.2.2. Explosive atmospheres caused
by air/dust mixtures
2.2.2.1. Equipment must be designed and
constructed so that ignition of air/dust mixtures is prevented, even in the
event of frequently occurring disturbances or equipment operating faults which
normally have to be taken into account.
2.2.2.2. With regard to surface
temperatures, requirement 2.1.2.3 applies.
2.2.2.3. With regard to protection against
dust, requirement 2.1.2.2 applies.
2.2.2.4. With regard to the safe opening of
equipment parts, requirement 2.2.1.3 applies.
2.3. Requirements
applicable to equipment in category 3 of equipment-group II
2.3.1. Explosive atmospheres caused
by gases, vapours or mists
2.3.1.1. Equipment must be so designed and
constructed as to prevent foreseeable ignition sources which can occur during
normal operation.
2.3.1.2. Surface temperatures must not
exceed the stated maximum surface temperatures under intended operating
conditions. Higher temperatures in exceptional circumstances may be allowed
only if the manufacturer adopts special additional protective measures.
2.3.2. Explosive atmospheres caused
by air/dust mixtures
2.3.2.1. Equipment must be so designed and
constructed that air/dust mixtures cannot be ignited by foreseeable ignition
sources likely to exist during normal operation.
2.3.2.2. With regard to surface
temperatures, requirement 2.1.2.3 applies.
2.3.2.3. Equipment, including cable entries
and connecting pieces, must be so constructed that, taking into account the
size of its particles, dust can neither develop explosive mixtures with air nor
form dangerous accumulations inside the equipment.
3. SUPPLEMENTARY REQUIREMENTS IN RESPECT
OF PROTECTIVE SYSTEMS
3.0. General
requirements
3.0.1. Protective systems must be
dimensioned in such a way as to reduce the effects of an explosion to a
sufficient level of safety.
ê 94/9/EC
è1 Corrigendum, OJ L 21, 26.1.2000, p. 42
3.0.2. Protective systems must be designed
and è1 capable of being positioned in such a way ç that
explosions are prevented from spreading through dangerous chain reactions or
flashover and incipient explosions do not become detonations.
ê 94/9/EC
3.0.3. In the event of a power failure,
protective systems must retain their capacity to function for a period
sufficient to avoid a dangerous situation.
3.0.4. Protective systems must not fail due
to outside interference.
3.1. Planning
and design
3.1.1. Characteristics of materials
With regard to the characteristics of
materials, the maximum pressure and temperature to be taken into consideration
at the planning stage are the expected pressure during an explosion occurring
under extreme operating conditions and the anticipated heating effect of the
flame.
3.1.2. Protective systems designed to
resist or contain explosions must be capable of withstanding the shock wave
produced without losing system integrity.
3.1.3. Accessories connected to protective
systems must be capable of withstanding the expected maximum explosion pressure
without losing their capacity to function.
3.1.4. The reactions caused by pressure in
peripheral equipment and connected pipe-work must be taken into consideration
in the planning and design of protective systems.
3.1.5. Pressure-relief systems
If it is likely that stresses on protective
systems will exceed their structural strength, provision must be made in the
design for suitable pressure-relief devices which do not endanger persons in
the vicinity.
3.1.6. Explosion suppression
systems
ê 94/9/EC
è1 Corrigendum, OJ L 21, 26.1.2000, p. 42
Explosion suppression systems must be so
planned and designed that they react to an incipient explosion at the earliest
possible stage in the event of an incident and counteract it è1 to best effect, with due regard to ç the maximum
rate of pressure increase and the maximum explosion pressure.
ê 94/9/EC
3.1.7. Explosion decoupling systems
Decoupling systems intended to disconnect
specific equipment as swiftly as possible in the event of incipient explosions
by means of appropriate devices must be planned and designed so as to remain
proof against the transmission of internal ignition and to retain their
mechanical strength under operating conditions.
3.1.8. Protective systems must be capable
of being integrated into a circuit with a suitable alarm threshold so that, if
necessary, there is cessation of product feed and output and shutdown of
equipment parts which can no longer function safely.
ê 94/9/EC
ANNEX III
MODULE EC-TYPE
EXAMINATION
1. This module
describes that part of the procedure by which a notified body ascertains and
attests that a specimen representative of the production envisaged meets the
relevant applicable provisions of the Directive.
2. The application
for the EC-type examination shall be lodged by the manufacturer or his
authorized representative established within the Community with a notified body of his choice.
The application
shall include:
–                        
the name and
address of the manufacturer and, if the application is lodged by the authorized
representative, his name and address in addition;
–                        
a written
declaration that the same application has not been lodged with any other
notified body;
–                        
the technical
documentation, as described in point 3.
The applicant
shall place at the disposal of the notified body a specimen representative of
the production envisaged and hereinafter called «type». The notified body
may request further specimens if needed for carrying out the test programme.
3. The technical
documentation shall enable the conformity of the product with the requirements
of the Directive to be assessed. It shall, to the extent necessary for such
assessment, cover the design, manufacture and operation of the product and
shall to that extent contain:
–                        
a general
type-description;
–                        
design and
manufacturing drawings and layouts of components, sub-assemblies, circuits,
etc.;
–                        
descriptions and
explanations necessary for the understanding of said drawings and layouts
and the operation of the product;
–                        
a list of the
standards referred to in Article 5, applied in full or in part, and descriptions of
the solutions adopted to meet the essential requirements of the Directive
where the standards referred to in Article 5 have not been applied;
–                        
results of design
calculations made, examinations carried out, etc.;
–                        
test reports.
4. The notified
body shall:
4.1. examine the
technical documentation, verify that the type has been manufactured in
conformity with the technical documentation and identify the elements which
have been designed in accordance with the relevant provisions of the standards
referred to in Article 5, as well as the components which have been designed
without applying the relevant provisions of those standards;
4.2. perform or
have performed the appropriate examinations and necessary tests to check
whether the solutions adopted by the manufacturer meet the essential
requirements of the Directive where the standards referred to in Article 5 have not been applied;
4.3. perform or
have performed the appropriate examinations and necessary tests to check
whether these have actually been applied, where the manufacturer has chosen to
apply the relevant standards;
4.4. agree with
the applicant the location where the examinations and necessary tests shall be
carried out.
5. Where the type
meets the provisions of the Directive, the notified body shall issue an
EC-type-examination certificate to the applicant. The certificate shall
contain the name and address of the manufacturer, conclusions of the
examination and the necessary data for identification of the approved type.
A list of the significant parts of the technical documentation shall be annexed to
the certificate and a copy kept by the notified body.
If the
manufacturer or his authorized representative established in the Community is denied a type certification, the notified body
shall provide detailed reasons for such denial.
Provision shall be
made for an appeals procedure.
6. The applicant
shall inform the notified body which holds the technical documentation
concerning the
EC-type-examination certificate
of all modifications to the approved equipment or protective system which must
receive further approval where such changes may affect conformity with the essential requirements or with the
prescribed conditions for use of the product. This further approval is given in
the form of an addition to the original EC-type-examination certificate.
7. Each notified
body shall communicate to the other notified bodies the relevant information
concerning the
EC-type-examination certificates
and additions issued and withdrawn.
8. The other
notified bodies may receive copies of the EC-type-examination certificates and/or their additions. The annexes
to the certificates shall be kept at the disposal of the other notified bodies.
9. The
manufacturer or his authorized representative established in the Community shall keep with the technical documentation copies
of EC-type-examination
certificates
and their additions for a period ending at least 10 years after the last
equipment or protective system was manufactured.
Where neither the
manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical
documentation available shall be the responsibility of the person who places
the product on the
Community market.
ò new
MODULE:
EU-TYPE EXAMINATION
1. EU-type examination
is the part of a conformity assessment procedure in which a notified body
examines the technical design of a product and verifies and attests that the
technical design of the product meets the requirements of this Directive that apply
to it.
2. EU-type examination
shall be carried out with the examination of a specimen, representative of the
production envisaged, of the complete product (production type).
3. The
manufacturer shall lodge an application for EU-type examination with a single
notified body of his choice.
The application
shall include:
–                        
the name and address
of the manufacturer and, if the application is lodged by the authorised
representative, his name and address as well,
–                        
a written declaration
that the same application has not been lodged with any other notified body,
–                        
the technical documentation.
The technical documentation shall make it possible to assess the product's conformity
with the applicable requirements of this Directive and shall include an
adequate analysis and assessment of the risk(s). The technical documentation
shall specify the applicable requirements and cover, as far as relevant for the
assessment, the design, manufacture and operation of the product. The technical
documentation shall contain at least the following elements:
–              
a general description
of the product,
–              
conceptual design and
manufacturing drawings and schemes of components, sub-assemblies, circuits,
etc.,
–              
descriptions and
explanations necessary for the understanding of those drawings and schemes and
the operation of the product,
–              
a list of the
harmonised standards and/or other relevant technical specifications the
references of which have been published in the Official Journal of the
European Union, applied in full or in part, and descriptions of the
solutions adopted to meet the essential health and safety requirements of this
Directive where those harmonised standards have not been applied. In the event
of partly applied harmonised standards, the technical documentation shall
specify the parts which have been applied,
–              
results of design
calculations made, examinations carried out, etc., and
–              
test reports,
–                        
the specimens
representative of the production envisaged. The notified body may request
further specimens if needed for carrying out the test programme,
–                        
the supporting
evidence for the adequacy of the technical design solution. This supporting
evidence shall mention any documents that have been used, in particular where
the relevant harmonised standards and/or technical specifications have not been
applied in full. The supporting evidence shall include, where necessary, the
results of tests carried out by the appropriate laboratory of the manufacturer,
or by another testing laboratory on his behalf and under his responsibility.
4. The notified
body shall:
4.1. verify that
the specimen(s) have been manufactured in conformity with the technical
documentation, and identify the elements which have been designed in accordance
with the applicable provisions of the relevant harmonised standards and/or
technical specifications, as well as the elements which have been designed
without applying the relevant provisions of those standards;
4.2. carry out
appropriate examinations and tests, or have them carried out, to check whether,
where the manufacturer has chosen to apply the solutions in the relevant
harmonised standards and/or technical specifications, these have been applied
correctly;
4.3. carry out
appropriate examinations and tests, or have them carried out, to check whether,
where the solutions in the relevant harmonised standards and/or technical
specifications have not been applied, the solutions adopted by the manufacturer
meet the corresponding essential health and safety requirements of this
Directive;
4.4. agree with
the manufacturer on a location where the examinations and tests will be carried
out.
5. The notified
body shall draw up an evaluation report that records the activities undertaken
in accordance with point 4 and their outcomes. Without prejudice to its
obligations vis-à vis the notifying authorities, the notified body shall release
the content of that report, in full or in part, only with the agreement of the
manufacturer.
6. Where the type
meets the requirements of this Directive that apply to the product concerned,
the notified body shall issue an EU-type examination certificate to the
manufacturer. The certificate shall contain the name and address of the
manufacturer, the conclusions of the examination, the conditions (if any) for
its validity and the necessary data for identification of the approved type.
The certificate may have one or more annexes attached.
The certificate
and its annexes shall contain all relevant information to allow the conformity
of manufactured products with the examined type to be evaluated and to allow
for in-service control.
Where the type
does not satisfy the applicable requirements of this Directive, the notified
body shall refuse to issue an EU-type examination certificate and shall inform
the applicant accordingly, giving detailed reasons for its refusal.
7. The notified
body shall keep itself apprised of any changes in the generally acknowledged
state of the art which indicate that the approved type may no longer comply
with the applicable requirements of this Directive, and shall determine whether
such changes require further investigation. If so, the notified body shall
inform the manufacturer accordingly.
The manufacturer
shall inform the notified body that holds the technical documentation relating
to the EU-type examination certificate of all modifications to the approved
type that may affect the conformity of the product with the essential health
and safety requirements of this Directive or the conditions for validity of the
certificate. Such modifications shall require additional approval in the form
of an addition to the original EU-type examination certificate.
8. Each notified
body shall inform its notifying authorities concerning the EU-type examination
certificates and/or any additions thereto which it has issued or withdrawn, and
shall, periodically or upon request, make available to its notifying
authorities the list of certificates and/or any additions thereto refused,
suspended or otherwise restricted.
Each notified
body shall inform the other notified bodies concerning the EU-type examination
certificates and/or any additions thereto which it has refused, withdrawn,
suspended or otherwise restricted, and, upon request, concerning the
certificates and/or additions thereto which it has issued.
The Commission,
the Member States and the other notified bodies may, on request, obtain a copy
of the EU-type examination certificates and/or additions thereto. On request,
the Commission and the Member States may obtain a copy of the technical
documentation and the results of the examinations carried out by the notified
body. The notified body shall keep a copy of the EU-type examination
certificate, its annexes and additions, as well as the technical file including
the documentation submitted by the manufacturer, until the expiry of the
validity of the certificate.
9. The
manufacturer shall keep a copy of the EU-type examination certificate, its
annexes and additions together with the technical documentation at the disposal
of the national authorities for 10 years after the product has been placed on the
market.
10. The
manufacturer's authorised representative may lodge the application referred to
in point 3 and fulfil the obligations set out in points 7 and 9, provided that
they are specified in the mandate.
ê 94/9/EC
ANNEX IV
MODULE: PRODUCTION
QUALITY ASSURANCE
1. This module
describes the procedure whereby the manufacturer who satisfies the
obligations of point 2 ensures and declares that the products concerned are in
conformity with the
type as described in the EC-type-examination certificate and satisfy the requirements of the
Directive which apply to them. The manufacturer, or his authorized representative established in the Community, shall affix the CE marking to each piece of
equipment and draw up a written declaration of conformity. The CE marking shall
be accompanied by the identification number of the notified body responsible
for EC monitoring, as specified in Section 4.
2. The
manufacturer shall operate an approved quality system for production, final
equipment inspection and testing as specified in Section 3 and shall be subject
to monitoring as specified in Section 4.
3.
Quality system
3.1. The
manufacturer shall lodge an application for assessment of his quality system
with a notified body of his choice, for the equipment concerned.
The application
shall include:
–                        
all relevant
information for the product category envisaged;
–                        
the documentation
concerning the quality system;
–                        
technical
documentation on the approved type and a copy of the EC-type-examination
certificate.
3.2. The quality
system shall ensure compliance of the equipment with the type as described
in the EC-type-examination certificate and with the requirements of the
Directive which apply to them.
All the elements,
requirements and provisions adopted by the manufacturer shall be documented in
a systematic and orderly manner in the form of written policies, procedures
and instructions. The quality system documentation must permit a consistent
interpretation of quality programmes, plans, manuals and records.
It shall contain,
in particular, an adequate description of
–                        
the quality
objectives and the organizational structure, responsibilities and powers of
the management with regard to equipment quality;
–                        
the manufacturing,
quality control and quality assurance techniques, processes and systematic
actions which will be used;
–                        
the examinations
and tests which will be carried out before, during and after manufacture and
the frequency with which they will be carried out;
–                        
the quality
records, such as inspection reports and test data, calibration data, reports on
the qualifications of the personnel concerned, etc.;
–                        
the means to
monitor the achievement of the required equipment quality and the effective
operation of the quality system.
3.3. The notified
body shall assess the quality system to determine whether it satisfies the
requirements referred to in Section 3.2. It shall presume conformity with
these requirements in respect of quality systems which implement the relevant
harmonized standard. The auditing team shall have at least one member with
experience of evaluation in the equipment technology concerned. The evaluation procedure shall include an
inspection visit to the manufacturer's premises. The decision shall be notified
to the manufacturer. The notification shall contain the conclusions of the
examination and the reasoned assessment decision.
3.4. The
manufacturer shall undertake to fulfil the obligations arising out of the
quality system as approved and to uphold the system so that it remains adequate
and efficient.
The manufacturer
or his authorized representative shall inform the notified body which has
approved the quality system of any intended updating of the quality system.
The notified body
shall evaluate the modifications proposed and decide whether the amended
quality system will still satisfy the requirements referred to in Section 3.2 or
whether a re-assessment is required.
It shall notify
its decision to the manufacturer. The notification shall contain the
conclusions of the examination and the reasoned assessment decision.
4.
Surveillance under the responsibility of the notified body
4.1. The purpose
of surveillance is to make sure that the manufacturer duly fulfils the
obligations arising out of the approved quality system.
4.2. The
manufacturer shall, for inspection purposes, allow the notified body access to
the manufacture, inspection, testing and storage premises and shall provide
it with all necessary information, in particular
–                        
the quality system
documentation
–                        
the quality
records, such as inspection reports and test data, calibration data, reports on the qualifications of
the personnel concerned, etc.
4.3. The notified
body shall periodically carry out audits to ensure that the manufacturer
maintains and applies the quality system and shall provide an audit report to
the manufacturer.
4.4. Furthermore,
the notified body may pay unexpected visits to the manufacturer. During such
visits, the notified body may carry out tests, or arrange for tests to be
carried out, to check that the quality system is functioning correctly, if
necessary. The notified body shall provide the manufacturer with a visit report and, if a test has taken
place, with a test report.
5. The
manufacturer shall, for a period ending at least 10 years after the last piece
of equipment was manufactured, keep at the disposal of the national
authorities:
–                        
the documentation
referred to in the second indent of Section 3.1;
–                        
the updating
referred to in the second paragraph of Section 3.4;
–                        
the decisions and
reports from the notified body which are referred to in Section 3.4, last
paragraph, Section 4.3 and Secton 4.4.
6. Each notified
body shall apprise the other notified bodies of the relevant information
concerning the quality system approvals issued and withdrawn.
ò new
MODULE: CONFORMITY
TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS
1. Conformity to
type based on quality assurance of the production process is the part of a
conformity assessment procedure whereby the manufacturer fulfils the
obligations laid down in points 2 and 5, and ensures and declares on his sole
responsibility that the products concerned are in conformity with the type
described in the EU-type examination certificate and satisfy the requirements of
this Directive that apply to them.
2. Manufacturing
The manufacturer
shall operate an approved quality system for production, final product
inspection and testing of the products concerned as specified in point 3, and
shall be subject to surveillance as specified in point 4.
3. Quality system
3.1. The
manufacturer shall lodge an application for assessment of his quality system
with the notified body of his choice, for the products concerned.
The application
shall include:
–                        
the name and address
of the manufacturer and, if the application is lodged by the authorised
representative, his name and address as well,
–                        
a written declaration
that the same application has not been lodged with any other notified body,
–                        
all relevant
information for the product category envisaged,
–                        
the documentation
concerning the quality system,
–                        
the technical
documentation of the approved type and a copy of the EU-type examination
certificate.
3.2. The quality
system shall ensure that the products are in conformity with the type described
in the EU-type examination certificate and comply with the requirements of this
Directive that apply to them.
All the elements,
requirements and provisions adopted by the manufacturer shall be documented in
a systematic and orderly manner in the form of written policies, procedures and
instructions. The quality system documentation shall permit a consistent
interpretation of the quality programmes, plans, manuals and records.
It shall, in
particular, contain an adequate description of:
–                        
the quality objectives
and the organisational structure, responsibilities and powers of the management
with regard to product quality,
–                        
the corresponding manufacturing,
quality control and quality assurance techniques, processes and systematic
actions that will be used,
–                        
the examinations and
tests that will be carried out before, during and after manufacture, and the
frequency with which they will be carried out,
–                        
the quality records,
such as inspection reports and test data, calibration data, qualification
reports on the personnel concerned, etc., and
–                        
the means of
monitoring the achievement of the required product quality and the effective
operation of the quality system.
3.3. The notified
body shall assess the quality system to determine whether it satisfies the
requirements referred to in point 3.2.
It shall presume
conformity with those requirements in respect of the elements of the quality
system that comply with the corresponding specifications of the national
standard that implements the relevant harmonised standard and/or technical
specifications.
In addition to
experience in quality management systems, the auditing team shall have at least
one member with experience of evaluation in the relevant product field and
product technology concerned, and knowledge of the applicable requirements of this
Directive. The audit shall include an assessment visit to the manufacturer's premises.
The auditing team shall review the technical documentation referred to in point
3.1, fifth indent, to verify the manufacturer's ability to identify the
relevant requirements of this Directive and to carry out the necessary
examinations with a view to ensuring compliance of the product with those
requirements.
The decision
shall be notified to the manufacturer. The notification shall contain the
conclusions of the audit and the reasoned assessment decision.
3.4. The
manufacturer shall undertake to fulfil the obligations arising out of the
quality system as approved and to maintain it so that it remains adequate and
efficient.
3.5. The
manufacturer shall keep the notified body that has approved the quality system
informed of any intended change to the quality system.
The notified body
shall evaluate any proposed changes and decide whether the modified quality
system will continue to satisfy the requirements referred to in point 3.2 or
whether a reassessment is necessary.
It shall notify
the manufacturer of its decision. The notification shall contain the
conclusions of the examination and the reasoned assessment decision.
4. Surveillance
under the responsibility of the notified body
4.1. The purpose
of surveillance is to make sure that the manufacturer duly fulfils the
obligations arising out of the approved quality system.
4.2. The
manufacturer shall, for assessment purposes, allow the notified body access to
the manufacture, inspection, testing and storage sites and shall provide it
with all necessary information, in particular:
–                        
the quality system
documentation,
–                        
the quality records,
such as inspection reports and test data, calibration data, qualification
reports on the personnel concerned, etc.
4.3. The notified
body shall carry out periodic audits to make sure that the manufacturer maintains
and applies the quality system and shall provide the manufacturer with an audit
report.
4.4. In addition,
the notified body may pay unexpected visits to the manufacturer. During such
visits the notified body may, if necessary, carry out product tests, or have
them carried out, in order to verify that the quality system is functioning
correctly. The notified body shall provide the manufacturer with a visit report
and, if tests have been carried out, with a test report.
5. Conformity
marking and declaration of conformity
5.1. The
manufacturer shall affix the required conformity markings set out in this
Directive, and, under the responsibility of the notified body referred to in
point 3.1, the latter's identification number to each individual product that
is in conformity with the type described in the EU-type examination certificate
and satisfies the applicable requirements of this Directive.
5.2. The
manufacturer shall draw up a written declaration of conformity for each product
model and keep it at the disposal of the national authorities for 10 years
after the product has been placed on the market. The declaration of conformity shall
identify the product model for which it has been drawn up.
A copy of the
declaration of conformity shall be made available to the relevant authorities
upon request.
6. The
manufacturer shall, for a period ending at least 10 years after the product has
been placed on the market, keep at the disposal of the national authorities:
–                        
the documentation
referred to in point 3.1,
–                        
the change referred to
in point 3.5, as approved,
–                        
the decisions and
reports of the notified body referred to in points 3.5, 4.3 and 4.4.
7. Each notified
body shall inform its notifying authorities of quality system approvals issued
or withdrawn, and shall, periodically or upon request, make available to its
notifying authorities the list of quality system approvals refused, suspended
or otherwise restricted.
Each notified
body shall inform the other notified bodies of quality system approvals which
it has refused, suspended, withdrawn or otherwise restricted, and, upon
request, of quality system approvals which it has issued.
8. Authorised
representative
The
manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled
by his authorised representative, on his behalf and under his responsibility,
provided that they are specified in the mandate.
ê 94/9/EC
ANNEX V
MODULE: PRODUCT
VERIFICATION
1. This module
describes the procedure whereby a manufacturer or his authorized representative established within the Community checks and attests that the equipment subject to
the provisions of point 3 are in conformity with the type as described in the
EC-type-examination certificate and satisfy the relevant requirements of the
Directive.
2. The
manufacturer shall take all measures necessary to ensure that the manufacturing
process guarantees conformity of the equipment with the type as described in
the EC-type-examination certificate and with the requirements of the Directive
which apply to them. The manufacturer or his authorized representative
established in the Community shall affix the CE marking to each piece of
equipment and shall draw up a declaration of conformity.
3. The notified
body shall carry out the appropriate examinations and tests in order to
check the conformity of the equipment, protective system or device referred to
in Article 1 (2), with the relevant requirements of the Directive, by examining
and testing every product as specified in Section 4.
The manufacturer
or his authorized representative shall keep a copy of the declaration of
conformity for a period ending at least 10 years after the last piece of
equipment was manufactured.
4.
Verification by examination and testing of each piece of equipment.
4.1. All equipment
shall be individually examined and appropriate tests as set out in the relevant
standard(s)
referred to in Article 5 or equivalent tests shall be carried out in order to verify their conformity with the type
as described in the EC-type-examination certificate and the relevant
requirements of the Directive.
4.2. The notified
body shall affix or have affixed its identification number to each approved
item of equipment and shall draw up a written certificate of conformity
relating to the tests carried out.
4.3. The
manufacturer or his authorized representative shall ensure that he is able to
supply the notified body's certificates of conformity on request.
ò new
MODULE: CONFORMITY
TO TYPE BASED ON PRODUCT VERIFICATION
1. Conformity to
type based on product verification is the part of a conformity assessment
procedure whereby the manufacturer fulfils the obligations laid down in points
2, 5.1 and 6, and ensures and declares on his sole responsibility that the
products concerned, which have been subject to the provisions of point 3, are
in conformity with the type described in the EU-type examination certificate
and satisfy the requirements of this Directive that apply to them.
2. Manufacturing
The manufacturer
shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured products with the approved
type described in the EU-type examination certificate and with the requirements
of this Directive that apply to them.
3. Verification
A notified body
chosen by the manufacturer shall carry out appropriate examinations and tests
in order to check the conformity of the products with the approved type
described in the EU-type examination certificate and with the appropriate
requirements of this Directive.
The examinations
and tests to check the conformity of the products with the appropriate
requirements shall be carried out by examination and testing of every product
as specified in point 4.
4. Verification
of conformity by examination and testing of every product
4.1. All products
shall be individually examined and appropriate tests set out in the relevant
harmonised standard(s) and/or technical specifications, or equivalent tests,
shall be carried out in order to verify conformity with the approved type described
in the EU-type examination certificate and with the appropriate requirements of
this Directive.
In the absence of
such a harmonised standard, the notified body concerned shall decide on the
appropriate tests to be carried out.
4.2. The notified
body shall issue a certificate of conformity in respect of the examinations and
tests carried out, and shall affix its identification number to each approved
product or have it affixed under its responsibility.
The manufacturer
shall keep the certificates of conformity available for inspection by the
national authorities for 10 years after the product has been placed on the
market.
5. Conformity
marking and declaration of conformity
5.1. The
manufacturer shall affix the required conformity markings set out in this
Directive, and, under the responsibility of the notified body referred to in
point 3, the latter's identification number to each individual product that is
in conformity with the approved type described in the EU-type examination
certificate and satisfies the applicable requirements of this Directive.
5.2. The
manufacturer shall draw up a written declaration of conformity for each product
model and keep it at the disposal of the national authorities, for 10 years
after the product has been placed on the market. The declaration of conformity
shall identify the product model for which it has been drawn up.
A copy of the
declaration of conformity shall be made available to the relevant authorities
upon request.
If the notified
body referred to in point 3 agrees and under its responsibility, the
manufacturer may also affix the notified body's identification number to the
products.
6. If the
notified body agrees and under its responsibility, the manufacturer may affix
the notified body's identification number to the products during the
manufacturing process.
7. Authorised
representative
The
manufacturer's obligations may be fulfilled by his authorised representative,
on his behalf and under his responsibility, provided that they are specified in
the mandate. An authorised representative may not fulfil the manufacturer's
obligations set out in point 2.
ê 94/9/EC
ANNEX VI
MODULE: CONFORMITY
TO TYPE
1. This module
describes that part of the procedure whereby the manufacturer or his authorized
representative established within the Community ensures and declares that the
equipment in question is in conformity with the type as described in the
EC-type-examination
certificate and satisfies the requirements of the Directive
applicable to it. The manufacturer or his authorized
representative established within the Community shall affix the CE marking to
each piece of equipment and draw up a written declaration of conformity.
2. The
manufacturer shall take all measures necessary to ensure that the manufacturing
process assures compliance of the manufactured equipment with the type as described in the EC-type-examination certificate
and with the relevant requirements of the Directive.
3. The
manufacturer or his authorized representative shall keep a copy of the
declaration of conformity for a period ending at least 10 years after the last
piece of equipment was manufactured. Where neither the manufacturer nor his
authorized representative is established within the Community, the obligation
to keep the technical documentation
available shall be the responsibility of the person who places the equipment or
protective system on the Community market.
For each piece of
equipment manufactured, tests relating to the anti-explosive protection aspects
of the product shall be carried out by the manufacturer or on his behalf.
The tests shall be carried out under the responsibility of a notified body,
chosen by the manufacturer.
On the
responsibility of the notified body, the manufacturer shall affix the former's
identification number during the manufacturing process.
ò new
MODULE: CONFORMITY
TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING
1. Conformity to
type based on internal production control plus supervised product testing is
the part of a conformity assessment procedure whereby the manufacturer fulfils
the obligations laid down in points 2, 3 and 4, and ensures and declares on his
sole responsibility that the products concerned are in conformity with the type
described in the EU-type examination certificate and satisfy the requirements of
this Directive that apply to them.
2. Manufacturing
The manufacturer
shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured products with the type
described in the EU-type examination certificate and with the requirements of this
Directive that apply to them.
3. Product checks
For each
individual product manufactured one or more tests on one or more specific
aspects of the product shall be carried out by the manufacturer or on his
behalf, in order to verify conformity with the type described in the EU-type
examination certificate and with the corresponding requirements of this
Directive. The tests shall be carried out under the responsibility of a
notified body, chosen by the manufacturer.
The manufacturer
shall, under the responsibility of the notified body, affix the notified body's
identification number during the manufacturing process.
4. Conformity
marking and declaration of conformity
4.1. The
manufacturer shall affix the required conformity markings set out in this
Directive to each individual product that is in conformity with the type
described in the EU-type examination certificate and satisfies the applicable
requirements of this Directive.
4.2. The
manufacturer shall draw up a written declaration of conformity for a product
model and keep it at the disposal of the national authorities for 10 years
after the product has been placed on the market. The declaration of conformity shall
identify the product model for which it has been drawn up.
A copy of the
declaration of conformity shall be made available to the relevant authorities
upon request.
5. Authorised
representative
The
manufacturer's obligations set out in point 4 may be fulfilled by his
authorised representative, on his behalf and under his responsibility, provided
that they are specified in the mandate.
ê 94/9/EC
ANNEX VII
MODULE: PRODUCT
QUALITY ASSURANCE
1. This module
describes the procedure whereby the manufacturer who satisfies the
obligations of Section 2 ensures and declares that the equipment is in
conformity with the type as described in the EC-type-examination certificate.
The manufacturer or his authorized representative established within the Community shall affix the CE marking to each product and
draw up a written declaration of conformity. The CE marking shall be
accompanied by the identification number of the notified body responsible for
surveillance as specified in Section 4.
2. The
manufacturer shall operate an approved quality system for the final inspection
and testing of equipment as specified in Section 3 below and shall be subject
to surveillance as specified in Section 4 below.
3.
Quality system
3.1. The
manufacturer shall lodge an application for assessment of his quality system for the equipment, with a notified body of his
choice. 
The application
shall include:
–                        
all relevant
information for the product category envisaged;
–                        
documentation on
the quality system;
–                        
technical
documentation on the approved type and a copy of the EC-type-examination
certificate.
3.2. Under the
quality system, each piece of equipment shall be examined and appropriate tests
as set out in the relevant standard(s) referred to in Article 5 or equivalent
tests shall be carried out in order to ensure its conformity with the relevant
requirements of the Directive. All the elements, requirements and provisions
adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and
instructions. This quality system documentation must permit a
consistent interpretation of the quality programmes, plans, manuals and
records.
It shall contain,
in particular, an adequate description of:
–                        
the quality objectives
and the organizational structure, responsibilities and powers of the management
with regard to product quality;
–                        
the examinations
and tests which will be carried out after manufacture;
–                        
the means to
monitor the effective operation of the quality system;
–                        
quality records,
such as inspection reports and test data, calibration data, reports on the
qualifications of the personnel concerned, etc.
3.3. The notified
body shall assess the quality system to determine whether it satisfies the
requirements referred to in Section 3.2. It shall presume conformity with
these requirements in respect of quality systems which implement the relevant
harmonized standard.
The auditing team
shall have at least one member experienced as an assessor in the product
technology concerned. The assessment procedure shall include an assessment
visit to the manufacturer's premises.
The decision shall
be notified to the manufacturer. The notification shall contain the conclusions
of the examination and the reasoned assessment decision.
3.4. The
manufacturer shall undertake to discharge the obligations arising from the
quality system as approved and to maintain it in an appropriate and efficient
manner.
The manufacturer
or his authorized representative shall inform the notified body which has
approved the quality system of any intended updating of the quality system.
The notified body
shall evaluate the modifications proposed and decide whether the modified
quality system will still satisfy the requirements referred to in Section 3.2 or
whether a re-assessment is required.
It shall notify
its decision to the manufacturer. The notification shall contain the
conclusions of the examination and the reasoned assessment decision.
4.
Surveillance under the responsibility of the notified body
4.1. The
purpose of surveillance is to ensure that the manufacturer duly fulfils the
obligations arising out of the approved quality system.
4.2. The
manufacturer shall for inspection purposes allow the notified body access to
the inspection, testing and storage premises and shall provide it with all
necessary information, in particular:
–                        
quality system
documentation;
–                        
technical
documentation;
–                        
quality records,
such as inspection reports and test data, calibration data, reports on the
qualifications of the personnel concerned, etc.
4.3. The notified
body shall periodically carry out audits to ensure that the manufacturer
maintains and applies the quality system and shall provide an audit report to
the manufacturer.
4.4. Furthermore,
the notified body may pay unexpected visits to the manufacturer. At the time
of such visits, the notified body may carry out tests or arrange for tests to
be carried out in order to check the proper functioning of the quality system,
where necessary; it shall provide the manufacturer with a visit report and, if a test has been carried out, with a test
report.
5. The
manufacturer shall, for a period ending at least 10 years after the last piece
of equipment was manufactured, keep at the disposal of the national
authorities:
–                        
the documentation
referred to in the third indent of Section 3.1;
–                        
the updating
referred to in the second paragraph of Section 3.4;
–                        
the decisions and
reports from the notified body which are referred to in Section 3.4, last
paragraph, Section 4.3 and Section 4.4.
6. Each
notified body shall forward to the other notified bodies the relevant
information concerning the quality system approvals issued and withdrawn.
ò 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 responsibility that the products
concerned are in conformity with the type described in the EU-type examination
certificate and satisfy the requirements of this Directive that apply to them.
2. Manufacturing
The manufacturer
shall operate an approved quality system for final product inspection and
testing of the products concerned as specified in point 3 and shall be subject
to surveillance as specified in point 4.
3. Quality system
3.1. The
manufacturer shall lodge an application for assessment of his quality system
with the notified body of his choice, for the products concerned.
The application
shall include:
–                        
the name and address
of the manufacturer and, if the application is lodged by the authorised
representative, his name and address as well,
–                        
a written declaration
that the same application has not been lodged with any other notified body,
–                        
all relevant
information for the product category envisaged,
–                        
the documentation
concerning the quality system, and
–                        
the technical
documentation of the approved type and a copy of the EU-type examination
certificate.
3.2. The quality
system shall ensure compliance of the products with the type described in the
EU-type examination certificate and with the applicable requirements of this
Directive.
All the elements,
requirements and provisions adopted by the manufacturer shall be documented in
a systematic and orderly manner in the form of written policies, procedures and
instructions. The quality system documentation shall permit a consistent
interpretation of the quality programmes, plans, manuals and records.
It shall, in
particular, contain an adequate description of:
–                        
the quality objectives
and the organisational structure, responsibilities and powers of the management
with regard to product quality,
–                        
the examinations and
tests that will be carried out after manufacture,
–                        
the quality records,
such as inspection reports and test data, calibration data, qualification
reports on the personnel concerned, etc.,
–                        
the means of
monitoring the effective operation of the quality system.
3.3. The notified
body shall assess the quality system to determine whether it satisfies the
requirements referred to in point 3.2.
It shall presume
conformity with those requirements in respect of the elements of the quality
system that comply with the corresponding specifications of the national
standard that implements the relevant harmonised standard and/or technical
specification.
In addition to
experience in quality management systems, the auditing team shall have at least
one member with experience of evaluation in the relevant product field and
product technology concerned, and knowledge of the applicable requirements of this
Directive. The audit shall include an assessment visit to the manufacturer's
premises. The auditing team shall review the technical documentation referred
to in point 3.1, fifth indent, in order to verify the manufacturer's ability to
identify the relevant requirements of this Directive and to carry out the
necessary examinations with a view to ensuring compliance of the product with
those requirements.
The decision
shall be notified to the manufacturer. The notification shall contain the
conclusions of the audit and the reasoned assessment decision.
3.4. The
manufacturer shall undertake to fulfil the obligations arising out of the
quality system as approved and to maintain it so that it remains adequate and
efficient.
3.5. The
manufacturer shall keep the notified body that has approved the quality system
informed of any intended change to the quality system.
The notified body
shall evaluate any proposed changes and decide whether the modified quality
system will continue to satisfy the requirements referred to in point 3.2 or
whether a reassessment is necessary.
It shall notify
the manufacturer of its decision. The notification shall contain the
conclusions of the examination and the reasoned assessment decision.
4. Surveillance
under the responsibility of the notified body
4.1. The purpose
of surveillance is to make sure that the manufacturer duly fulfils the
obligations arising out of the approved quality system.
4.2. The
manufacturer shall, for assessment purposes, allow the notified body access to
the manufacture, inspection, testing and storage sites and shall provide it
with all necessary information, in particular:
–                        
the quality system
documentation,
–                        
the quality records,
such as inspection reports and test data, calibration data, qualification
reports on the personnel concerned, etc.
4.3. The notified
body shall carry out periodic audits to make sure that the manufacturer
maintains and applies the quality system and shall provide the manufacturer
with an audit report.
4.4. In addition,
the notified body may pay unexpected visits to the manufacturer. During such
visits the notified body may, if necessary, carry out product tests, or have
them carried out, in order to verify that the quality system is functioning
correctly. The notified body shall provide the manufacturer with a visit report
and, if tests have been carried out, with a test report.
5. Conformity
marking and declaration of conformity
5.1. The
manufacturer shall affix the required conformity markings set out in this
Directive, and, under the responsibility of the notified body referred to in
point 3.1, the latter's identification number to each individual product that
is in conformity with the type described in the EU-type examination certificate
and satisfies the applicable requirements of this Directive.
5.2. The
manufacturer shall draw up a written declaration of conformity for each product
model and keep it at the disposal of the national authorities for 10 years
after the product has been placed on the market. The declaration of conformity
shall identify the product model for which it has been drawn up.
A copy of the
declaration of conformity shall be made available to the relevant authorities
upon request.
6. The
manufacturer shall, for a period ending at least 10 years after the product has
been placed on the market, keep at the disposal of the national authorities:
–                        
the documentation
referred to in point 3.1,
–                        
the change referred to
in point 3.5, as approved,
–                        
the decisions and
reports of the notified body referred to in points 3.5, 4.3 and 4.4.
7. Each notified
body shall inform its notifying authorities of quality system approvals issued
or withdrawn, and shall, periodically or upon request, make available to its
notifying authorities the list of quality system approvals refused, suspended
or otherwise restricted.
Each notified
body shall inform the other notified bodies of quality system approvals which
it has refused, suspended or withdrawn, and, upon request, of quality system
approvals which it has issued.
8. Authorised
representative
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.
ê 94/9/EC
ANNEX VIII
MODUL: INTERNAL
CONTROL OF PRODUCTION
1. This module
describes the procedure whereby the manufacturer or his authorized
representative established within the Community, who carries out the
obligations laid down in Section 2, ensures and declares that the equipment satisfies the requirements of the Directive applicable to it. The manufacturer
or his authorized representative established within the Community shall affix
the CE marking to each piece of equipment and draw up a written declaration
of conformity.
2. The
manufacturer shall establish the technical documentation described in Section 3
and he or his authorized representative established within the Community shall
keep it at the disposal of the relevant national authorities for inspection
purposes for a period ending at least 10 years after the last piece of
equipment was manufactured.
Where neither the
manufacturer nor his authorized representative is established within the
Community, the obligation to keep the technical documentation available
shall be the responsibility of the person who places the equipment on the
Community market.
3. Technical
documentation shall enable the conformity of the equipment with the relevant
requirements of the Directive to be assessed. It shall, to the extent
necessary for such assessment, cover the design, manufacture and operation of
the product. It shall contain:
–                        
a general
description of the equipment,
–                        
conceptual design
and manufacturing drawings and schemes of components, sub-assemblies,
circuits, etc.,
–                        
descriptions and
explanations necessary for the understanding of said drawings and schemes and
the operation of the equipment,
–                        
a list of the
standards applied in full or in part, and descriptions of the solutions adopted
to meet the safety aspects of the Directive where the standards have not been
applied,
–                        
results of design
calculations made, examinations carried out, etc.,
–                        
test reports.
4. The
manufacturer or his authorized representative shall keep a copy of the declaration
of conformity with the technical documentation.
5. The
manufacturer shall take all measures necessary to ensure that the manufacturing
process guarantees compliance of the manufactured equipment with the technical
documentation referred to in Section 2 and with the requirements of the
Directive applicable to such equipment.
ò new
MODULE: INTERNAL
PRODUCTION CONTROL
1. Internal
production control is the conformity assessment procedure whereby the
manufacturer fulfils the obligations laid down in points 2, 3 and 4, and
ensures and declares on his sole responsibility that the products concerned
satisfy the requirements of this Directive that apply to them.
2. Technical
documentation
The manufacturer
shall establish the technical documentation. The documentation shall make it
possible to assess the product's conformity to the relevant requirements, and
shall include an adequate analysis and assessment of the risk(s).
The technical
documentation shall specify the applicable requirements and cover, as far as
relevant for the assessment, the design, manufacture and operation of the
product. The technical documentation shall contain at least the following
elements:
–                        
a general description
of the product,
–                        
conceptual design and
manufacturing drawings and schemes of components, sub-assemblies, circuits,
etc.
–                        
descriptions and
explanations necessary for the understanding of those drawings and schemes and
the operation of the product,
–                        
a list of the
harmonised standards and/or other relevant technical specifications the
references of which have been published in the Official Journal of the
European Union, applied in full or in part, and descriptions of the
solutions adopted to meet the essential health and safety requirements of this Directive
where those harmonised standards have not been applied. In the event of partly
applied harmonised standards, the technical documentation shall specify the
parts which have been applied,
–                        
results of design
calculations made, examinations carried out, etc., and
–                        
test reports.
3. Manufacturing
The manufacturer
shall take all measures necessary so that the manufacturing process and its
monitoring ensure compliance of the manufactured products with the technical
documentation referred to in point 2 and with the requirements of this Directive
that apply to them.
4. Conformity
marking and declaration of conformity
4.1. The
manufacturer shall affix the required conformity markings set out in this
Directive to each individual product that satisfies the applicable requirements
of this Directive.
4.2. The
manufacturer shall draw up a written declaration of conformity for a product
model and keep it together with the technical documentation at the disposal of
the national authorities for 10 years after the product has been placed on the
market. The declaration of conformity shall identify the product for which it
has been drawn up.
A copy of the
declaration of conformity shall be made available to the relevant authorities
upon request.
5. Authorised
representative
The
manufacturer's obligations set out in point 4 may be fulfilled by his
authorised representative, on his behalf and under his responsibility, provided
that they are specified in the mandate.
ê 94/9/EC
ANNEX IX
MODULE: UNIT
VERIFICATION
1. This module
describes the procedure whereby the manufacturer ensures and declares that
the equipment or protective system which has been issued with the certificate
referred to in Section 2 conforms to the requirements of the Directive which
are applicable to it. The manufacturer or
his authorized representative in the Community shall affix the CE marking to
the equipment or protective system and draw up a declaration of conformity.
2. The notified
body shall examine the individual equipment or protective system and carry out
the appropriate tests as set out in the relevant standard(s) referred to in
Article 5, or equivalent tests, to ensure its conformity with the relevant
requirements of the Directive.
The notified body
shall affix, or cause to be affixed, its identification number on the
approved equipment or protective system and shall draw up a certificate of
conformity concerning the tests carried out.
3. The aim of the
technical documentation is to enable conformity with the requirements of the
Directive to be assessed and the design, manufacture and operation of the
equipment or protective system to be understood.
The documentation
shall contain:
–                        
a general
description of the product;
–                        
conceptual design
and manufacturing drawings and layouts of components, sub-assemblies,
circuits, etc.;
–                        
descriptions and
explanations necessary for the understanding of said drawings and layouts and
the operation of the equipment or protective system;
–                        
a list of the
standards referred to in Article 5, applied in full or in part, and descriptions
of the solutions adopted to meet the essential requirements of the Directive
where the standards referred to in Article 5 have not been applied;
–                        
results of design
calculations made, examinations carried out, etc.;
–                        
test reports.
ò new
MODULE: CONFORMITY
BASED 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
requirements of this Directive that apply to it.
2. Technical
documentation
The manufacturer
shall establish the technical documentation and make it available to the
notified body referred to in point 4. The documentation shall make it possible
to assess the product's conformity with the relevant requirements, and shall
include an adequate analysis and assessment of the risk(s). The technical
documentation shall specify the applicable requirements and cover, as far as
relevant for the assessment, the design, manufacture and operation of the product.
The technical documentation shall contain at least the following elements:
–                        
a general description
of the product,
–                        
conceptual design and
manufacturing drawings and schemes of components, sub-assemblies, circuits,
etc.,
–                        
descriptions and
explanations necessary for the understanding of those drawings and schemes and
the operation of the product,
–                        
a list of the harmonised
standards and/or other relevant technical specifications the references of
which have been published in the Official Journal of the European Union,
applied in full or in part, and descriptions of the solutions adopted to meet
the essential health and safety requirements of this Directive where those
harmonised standards have not been applied. In the event of partly applied
harmonised standards, the technical documentation shall specify the parts which
have been applied,
–                        
results of design
calculations made, examinations carried out, etc., and
–                        
test reports.
The manufacturer
shall keep the technical documentation at the disposal of the relevant national
authorities for 10 years after the product has been placed on the market.
3. Manufacturing
The manufacturer
shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured product with the applicable
requirements of this Directive.
4. Verification
A notified body
chosen by the manufacturer shall carry out appropriate examinations and tests,
set out in the relevant harmonised standards and/or technical specifications,
or equivalent tests, to check the conformity of the product with the applicable
requirements of this Directive, or have them carried out. In the absence of
such a harmonised standard and/or technical specification the notified body
concerned shall decide on the appropriate tests to be carried out.
The notified body
shall issue a certificate of conformity in respect of the examinations and
tests carried out and shall affix its identification number to the approved
product, or have it affixed under its responsibility.
The manufacturer
shall keep the certificates of conformity at the disposal of the national
authorities for 10 years after the product has been placed on the market.
5. Conformity
marking and declaration of conformity
5.1. The
manufacturer shall affix the required conformity markings set out in this
Directive and, under the responsibility of the notified body referred to in point
4, the latter's identification number to each product that satisfies the
applicable requirements of this Directive.
5.2. The
manufacturer shall draw up a written declaration of conformity and keep it at
the disposal of the national authorities for 10 years after the product has
been placed on the market. The declaration of conformity shall identify the
product for which it has been drawn up.
A copy of the
declaration of conformity shall be made available to the relevant authorities
upon request.
6. Authorised
representative
The
manufacturer's obligations set out in points 2 and 5 may be fulfilled by his
authorised representative, on his behalf and under his responsibility, provided
that they are specified in the mandate.
ê 94/9/EC (new)
ANNEX X
A.
CE Marking
The CE conformity
marking shall consist of the initials «CE» taking the following form:
If the marking is
reduced or enlarged, the proportions given in the above graduated drawing must
be respected.
The various
components of the CE marking must have substantially the same vertical
dimension, which may not be less than 5 mm.
This minimum
dimension may be waived for small-scale equipment, protective systems or
devices referred to in Article 1 (2).
B.
Content of the EC declaration of conformity
The EC declaration
of conformity must contain the following elements:
–                        
the name or
identification mark and the address of the manufacturer or his authorized
representative established within the Community;
–                        
a description of
the equipment, protective system, or device referred to in Article 1 (2);
–                        
all relevant
provisions fulfilled by the equipment, protective system, or device referred
to in Article 1 (2);
–                        
where appropriate,
the name, identification number and address of the notified body and the number
of the EC-type-examination certificate;
–                        
where appropriate,
reference to the harmonized standards;
–                        
where
appropriate, the standards and technical specifications which have been used;
–                        
where appropriate,
references to other Community Directives which have been applied;
–                        
identification of
the signatory who has been empowered to enter into commitments on behalf of
the manufacturer or his authorized representative established within the
Community.
ANNEX XI
MINIMUM CRITERIA
TO BE TAKEN INTO ACCOUNT BY MEMBER STATES FOR THE NOTIFICATION OF BODIES
1. The body, its
director and the staff responsible for carrying out the verification tests
shall not be the designer, manufacturer, supplier or installer of equipment,
protective systems, or devices referred to in Article 1 (2) which they inspect,
nor the authorized representative of any of these parties. They shall become involved neither directly nor as authorized
representatives in the design, construction, marketing or maintenance of the
equipment, protective systems or devices referred to in Article 1 (2) in
question. This does not preclude the possibility of exchanges of technical
information between the manufacturer and the body.
2. The body and
its inspection staff shall carry out the verification tests with the highest
degree of professional integrity and technical competence and shall be free
from all pressures and inducements, particularly financial, which may
influence their judgement or the results of the inspection, especially from
persons or groups of persons with an interest in the result of verifications.
3. The body shall
have at its disposal the necessary staff and possess the necessary
facilities to enable it to perform properly the administrative and technical
tasks connected with verification; it shall also have access to the equipment
required for special verification.
4. The staff
responsible for inspection shall have:
–                        
sound technical
and professional training;
–                        
satisfactory
knowledge of the requirements of the tests which they carry out and adequate
experience of such tests;
–                        
the ability to
draw up the certificates, records and reports required to authenticate the
performance of the tests.
5. The
impartiality of inspection staff shall be guaranteed. Their remuneration shall
not depend on the number of tests carried out or on the results of such tests.
6. The body shall
take out liability insurance unless its liability is assumed by the State in
accordance with national law or the Member State itself is directly responsible
for the tests.
7. The staff of
the body shall be bound to observe professional secrecy with regard to all
information gained in carrying out its tasks (except vis-à-vis the competent administrative authorities of the
State in which its activities are carried out) under this Directive or any
provision of national law giving effect to it.
é
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 
   ||   ||   
_____________
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 
 – || 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 
[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.
[2]               COM(2011) 315 final.
[3]               Regulation (EU) No 182/2011 of the European Parliament
and of the Council of 16 February 2011 laying down the rules and the general
principles concerning mechanisms for control by Member States of the
Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p.13).
[4]               OJ C 77, 28. 3. 2002.
[5]               OJ C […], [Date], p. […].
[6]               OJ L 100, 19.4.1994, p. 1.
[7]               OJ L 218, 13.8.2008, p. 30.
[8]               OJ L 218, 13.8.2008, p. 82.
[9]               OJ No C 136, 4. 6. 1985, p. 1.
[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).
[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.
[14]             OJ L […], [Date], p. […].
[15]             OJ L 399, 30.12. 1989, p. 18.
[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).
[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).