CELEX: 52014PC0187
Language: en
Date: 2014-03-27
Title: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on cableway installations

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		52014PC0187
		
			Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on cableway installations /* COM/2014/0187 final - 2014/0107 (COD) */
			
				
		
		
			
			   	EXPLANATORY MEMORANDUM
1.           CONTEXT OF THE PROPOSAL
General context, reasons for and
objectives of this proposal 
Directive 2000/9/EC relating to cableway
installations designed to carry persons [1]
was adopted on 20 March 2000 and became applicable on 3 May 2002.
Directive 2000/9/EC ensures a high level of
safety for cableway installations for users, workers and third parties. It sets
out essential requirements with which cableway installations, their infrastructure,
subsystems and safety components must comply in order to be safe.
Directive 2000/9/EC is also an example of
that Union harmonisation legislation ensuring the free movement in the EU
single market, namely of subsystems and safety components for cableway
installations. It harmonises the conditions for the placing on the market and
putting into service of subsystems and safety components intended to be
incorporated into cableway installations. Manufacturers must demonstrate that
their subsystems or safety components have been designed and manufactured in
compliance with the essential requirements, affix the CE marking and provide
instructions for their incorporation into a cableway installation.
Directive 2000/9/EC is based on Article 114
of the Treaty on the Functioning of the European Union (hereinafter
"the Treaty"). It is a total harmonisation Directive based on the
“New Approach” principles, which requires manufacturers to ensure the compliance
of their products with the mandatory performance and safety requirements
provided for in the legislative instrument without however imposing specific
technical solutions or specifications.
Directive 2000/9/EC applies to cableway
installations designed to carry persons.
Traction by cable and the passenger
transport function are the principal criteria determining the scope of
Directive 2000/9/EC.
The main types of cableway installations
covered by Directive 2000/9/EC are funiculars, gondolas, detachable chair
lifts, fixed-grip chair lifts, aerial tramways, funitels, combined
installations (made of several cableway types, such as those of gondolas and
chairlifts) and drag lifts.
Cableway installations are defined as the
whole on-site system, consisting of infrastructure, subsystems and safety
components.
Cableway installations and their
infrastructure are directly affected by the characteristics of the region in
which they are located, by the nature and physical features of the terrain in
which they are installed, by their surroundings, by atmospheric and
meteorological factors as well as by structures and obstacles that may be found
in their vicinity either on the ground or in the air.
In this framework, the construction and
entry into service of cableway installations are subject to national
authorisation procedures.
Directive 2000/9/EC sets out harmonised essential
requirements with which cableway installations must comply, while Member States
remain competent to regulate other aspects such as land-use, regional planning
and environmental protection.
Safety components and subsystems are
subject to the principle of the free movement of goods Safety components bear
the CE marking indicating conformity with the requirements of the Directive
2000/9/EC, including the conformity assessment procedures.
The proposal intends to replace Directive
2000/9/EC by a Regulation, in line with the Commission’s simplification
objectives.
The proposal intends to align Directive
2000/9/EC to the “goods package” adopted in 2008 and in particular to the NLF
Decision EC No 768/2008. 
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 for importers, have been introduced, which are
crucial for improving the safety of products on the market. 
The Commission has already proposed the
alignment of nine other Directives to the NLF Decision within an “alignment
package” adopted on 21 November 2011. It has also proposed the alignment to the
NLF Decision of Directive 97/23/EC on pressure equipment[2].
In view of ensuring consistency across Union harmonisation legislation for industrial products, in accordance with the political
commitment resulting from the adoption of the NLF Decision and the legal
obligation provided for in Article 2 of the NLF Decision, it is necessary that
this proposal is in line with the provisions of the NLF Decision.
The proposal also intends to address some
difficulties that have been experienced in the implementation of Directive
2000/9/EC. More particularly, authorities, notified bodies and manufacturers
have had different views on whether certain types of installations come under
the scope of Directive 2000/9/EC and hence have to be manufactured and
certified in line with the directive’s requirements and procedures. Views also
differed on whether certain equipment should be considered as subsystem,
infrastructure or safety component. Furthermore the Directive does not specify
which type of conformity assessment procedure has to be applied to subsystems. 
Those divergent approaches led to market
distortions and different treatment of economic operators. Manufacturers and
operators of the installations concerned had to modify the equipment or to
undergo further certification which led to extra costs and to delays in the
authorisation and operation of those installations. 
The proposed Regulation intends therefore
to enhance legal clarity about the scope of Directive 2000/9/EC and thus a
better implementation of the relevant legal provisions.
Furthermore, Directive 2000/9/EC contains
provisions on the conformity assessment for subsystems. However, it does not
determine the concrete procedure to be followed by the manufacturer and the
notified body. Furthermore, it does not offer manufacturers the range of
conformity assessment procedures that are available for safety components. The
proposed Regulation aligns thus the conformity assessment procedures available
for subsystems with those already used for safety components, based on the
conformity assessment modules set out in Decision No 768/2008/EC establishing a
common framework for the marketing of products (NLF Decision). In this context,
it also provides for the affixing of the CE marking to indicate compliance with
its provisions, in line with the existing system for safety components.
The proposal takes into account Regulation
(EU) No 1025/2012 of the European Parliament and of the Council of 25 October
2012 on European Standardisation[3].
The proposal also takes into account the
proposal of the Commission of 13 February 2013 for a Regulation on market
surveillance of products[4],
which intends to set out a single legal instrument on market surveillance
activities in the field of non-food goods, consumer or non-consumer products
and products covered or not by Union harmonisation legislation. This proposal
merges the rules on market surveillance of Directive 2001/95/EC on general
product safety[5],
Regulation (EC) No 765/2008 of the European Parliament and of the Council
setting out the requirements for accreditation and market surveillance relating
to the marketing of products[6]
and of sector-specific harmonisation legislation in order to increase the
effectiveness of market surveillance activities within the Union. The proposed
Regulation on market surveillance of products contains also the relevant provisions
on market surveillance and safeguard clauses. Therefore, provisions in existing
sector specific harmonisation legislation that relate to market surveillance
and safeguard clauses should be removed from that harmonisation legislation.
The overacting objective of the proposed Regulation on market surveillance of
products is to simplify the Union market surveillance framework fundamentally
so that it works better for its main users: market surveillance authorities and
economic operators. Directive 2000/9/EC provides for a safeguard clause
procedure for subsystems and safety components. In line with the framework
intended to be established by the proposed Regulation on the market
surveillance of products, this proposal does not include the provisions on market
surveillance and safeguard clause procedures for subsystems and safety
components provided for in the NLF Decision. However, in order to ensure legal
clarity, it makes a reference to the proposed Regulation on market surveillance
of products.
Consistency with other policies and
objectives of the Union
This initiative is in
line with the Single Market Act[7], 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 THE
INTERESTED PARTIES AND IMPACT ASSESSMENT
Consultation of the interested parties
The revision of Directive 2000/9/EC has
been lengthy and extensively discussed since 2010. More particularly, it has
been discussed within the Member States Working Group on Cableway
Installations, with national experts responsible for the implementation of the
Directive, within the Standing Committee provided for by Directive 2000/9/EC, the
Administrative Cooperation Group for Market Surveillance of Cableway
Installations (AdCo) and the Cableway Installations Sectoral Group (CSG) of the
European Co-ordination of Notified Bodies, as well as with industry and user
associations.
Member States and stakeholders, including manufacturers' organisations,
notified bodies and representatives of standardisation bodies, have been
involved in the Impact Assessment process from the beginning. In the framework
of the Standing Committee provided for by Directive 2000/9/EC, regular
discussions took place about the functioning of the Directive and the potential
issues that would require improvements, either through legislative or
non-legislative means.
Additionally, three specific consultations
have been carried out.
The first consultation took place in the
first half of 2010 in the framework of the preparation of the Report on the
implementation of Directive 2000/9/EC provided for by its Article 21(4).
In its First Report on the implementation
of Directive 2000/9/EC[8],
the Commission noted that the Directive has been successful in establishing an
internal market for subsystems and safety components, while guaranteeing a
uniform and high level of safety. It also identified some issues to be
examined.
The issues to be examined were the
following:
–                        
The extent of the scope of Directive 2000/9/EC,
in particular with regard to new types of cableway installations;
–                        
The lack of an appropriate range of conformity assessment
procedures for subsystems, which has led to divergent interpretations and
implementation of the conformity assessment of subsystems;
–                        
The need to align Directive 2000/9/EC to the NLF
Decision.
The second and the third consultation took
place in 2012 as part of the Impact Assessment Study the first one concerned the
existing situation and the other one the policy options. The Final Report of
the Impact Assessment study has been formally presented and discussed at the Standing
Committee meetings held on 25 September 2012 and 8 April 2013, in which Member States and sectoral stakeholders had the opportunity to express a number of
opinions, contributions and position papers on the policy options included in
the study.
Stakeholders have actively contributed to
identify the issues needing solutions to improve the functioning of Directive
2000/9/EC. The majority of stakeholders agree with the problems identified. An
important number of respondents to the consultation carried out in the context
of the Impact Assessment Study have experienced problems with the definition of
Cableway installations and the borderline with the scope of the Directive
95/16/EC relating to lifts[9].
In view of the amount of information
collected and the rather technical issues, no open public consultation was
launched, as targeted expertise consultations were deemed more appropriate for
this quite technical initiative.
Collection and use of expertise - Impact
assessment 
An impact assessment on the revision of
Directive 2000/9/EC has been conducted.
Based on the information collected, the impact
assessment carried out by the Commission examined and compared three options:
Option 1 – “Do nothing” - No changes to
the existing situation
This option proposes no changes to Directive
2000/9/EC.
Option 2 –Intervention by non-legislative
measures
Option 2 considers the possibility of providing
more extensive guidance on the implementation of Directive 2000/9/EC with
regard to its scope and of recommending the application of specific conformity assessment
procedures for the assessment of subsystems, mainly via a redrafting of the
Application Guide to Directive 2000/9/EC.
Option 3 – Intervention by legislative
measures
This option consists in modifying Directive
2000/9/EC.
Combination of
options 2 and 3 were found to be the preferred solution because:
–                        
it is considered the most to address the problem
as it will provide clarification in the scope definitions and consistency and
flexibility of conformity assessment procedures for subsystems and safety
components;
–                        
it does not entail significant costs for
economic operators and notified bodies; for those who are already acting
responsibly, no significant economic or social impacts could be identified;
–                        
it will improve the functioning of the internal
market of subsystems and safety components by ensuring equal treatment of all
economic operators, notably importers and distributors, as well as notified
bodies;
–                        
option 1 does not provide answers to the problem
of legal uncertainty due to some provisions of Directive 2000/9/EC and therefore
will not lead to its better implementation.
The proposal includes:
·              
The clarification of the scope with regard to
cableway installations designed for both transport and leisure purposes;
·              
The introduction of a range of conformity
assessment procedures for subsystems based on the existing conformity
assessment modules for safety components as aligned to the NLF Decision;
·              
The alignment to the NLF Decision.
The impact of the proposal will guarantee a
fair level playing field for the economic operators and will enhance protection
of the safety of passengers and other users, workers and third parties.
3.           LEGAL elements of the proposal
3.1. Scope and definitions
The scope of the proposed Regulation
corresponds to the scope of Directive 2000/9/EC, and covers cableway
installations, including their infrastructure, as well as subsystems and safety
components for cableway installations.
The proposal clarifies and updates the
existing scope.
In particular, in light of the development
of new types of cableway installations, it is clarified that the exclusion of cableway
installations used for leisure purposes in fairgrounds or amusement parks does
not apply to cableway installations that are intended for a dual function,
namely of transporting persons and for leisure activities.
The proposal maintains the exclusion of
certain cableway installations intended for agricultural or industrial purposes,
but it clarifies that it also covers cableway installations intended for the
service of mountain shelters or huts that are not intended for the transport of
the public.
The current exclusion of cable-operated
ferries is also updated to all cable-operated installations where the users or
carriers are water-borne, such as cable-operated water ski installations.
The exclusions provided for in Directive
2000/9/EC relating to rack-and-pinion railways and chain-driven installations
are not reintroduced since these installations do not correspond to the
definition of cableway installations.
The general definitions resulting from the
alignment to the NLF Decision have been inserted.
3.2. Obligations of economic operators
The proposal contains, with regard to
subsystems and safety components, the typical provisions for product-related
Union harmonisation legislation and sets out the obligations of the relevant
economic operators (manufacturers, authorised representatives, importers and
distributors), in accordance with the NLF Decision.
3.3. Harmonised standards
Compliance with harmonised standards
provides for a presumption of conformity with the essential requirements.
Regulation (EU) No 1025/2012 sets out a horizontal legal framework for European
standardisation. The Regulation contains inter alia provisions on
standardisation requests from the Commission to the European Standardisation
Organisation, on the procedure for objections to harmonised standards and on
stakeholder participation in the standardisation process. Consequently the
provisions of Directive 2000/9/EC which cover the same aspects have not been
reintroduced in this proposal for reasons of legal certainty.
3.4. Conformity assessment
The proposal keeps the conformity
assessment procedures for safety components provided for under Directive
2000/9/EC. It however updates the corresponding modules in line with the NLF
Decision.
In particular, it keeps the requirement for
a notified body intervention in the design and production phase of all
subsystems and safety components.
The proposal introduces a range of conformity
assessment procedures for subsystems based on the conformity assessment modules
of the NLF Decision. In this framework, it also introduces the CE marking for
subsystems, as there is no reason to treat them differently than the safety
components, for which Directive 2000/9/EC provides already the affixing of the
CE marking to indicate their conformity with its requirements.
3.5. Notified bodies
Proper functioning of notified bodies is
crucial for ensuring a high level of health and safety protection and for the
confidence of all interested parties in the New Approach system.
Therefore, in line with the NLF Decision, the
proposal reinforces the notification criteria for notified bodies and
introduces specific requirements for notifying authorities.
3.6. Implementing acts
The proposal empowers the Commission to
adopt, where appropriate, implementing acts to ensure the uniform application
of this Regulation in respect of notified bodies that do not meet or no longer
meet the requirements for their notification.
Those implementing acts will be adopted in
accordance with the 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.
3.7. Final provisions
The proposed Regulation will become
applicable two years after its entry into force to allow manufacturers,
notified bodies and Member States time to adapt to the new requirements.
However, the designation of notified bodies
pursuant to the new requirements and process needs to start shortly after the
entry into force of this Regulation. This will ensure that by the date of
application of the proposed Regulation, sufficient notified bodies will have
been designated in accordance with the new rules so as to avoid problems with
production continuity and market supply.
A transitional provision is foreseen for
the certificates issued by notified bodies under Directive 2000/9/EC with
regard to subsystems and safety components so as to allow stocks to be absorbed
and ensure a smooth transition to the new requirements.
A transitional provision is foreseen for
the entry into service of cableway installations constructed under Directive
2000/9/EC so as to ensure a smooth transition to the new requirements.
Directive 2000/9/EC will be repealed and
replaced by the proposed Regulation.
3.8. Union competence, legal basis,
subsidiarity principle and legal form
Legal basis
The proposal is based on Article 114 of the
Treaty. 
Subsidiarity principle
The subsidiarity principle arises in
particular with regard to the newly added provisions aiming at the improvement
of effective enforcement of Directive 2000/9/EC, namely, the economic
operators' obligations, the traceability provisions, the provisions on the
assessment and notification of conformity assessment bodies.
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 Union, which undermines the objective of Directive 2000/9/EC. 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. Coordinated action
at Union 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 Union level.
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 proposal takes the form of a Regulation.
The proposed change from a Directive to a
Regulation takes into account the Commission's general objective to simplify
the regulatory environment and the need to ensure a uniform implementation
throughout the Union of the proposed legislation.
The proposed Regulation is based on Article
114 of the Treaty and aims to ensure the proper functioning of the internal
market for subsystems and safety components intended to be incorporated into
cableway installations, while maintaining the existing role for Member States
with respect to cableway installations. It imposes clear and detailed rules
which will become applicable in a uniform manner at the same time throughout
the Union.
In accordance with the
total harmonisation principles, Member States are not allowed to impose more
stringent or additional requirements in their national legislation for the
placing on the market of subsystems and safety components. In particular, the
mandatory essential requirements and the conformity assessment procedures to be
followed by manufacturers must be identical in all Member States.
The same applies with
regard to the provisions that have been introduced as a result from the
alignment to the NLF Decision. Those provisions are clear and sufficiently
precise to be applied directly by the actors concerned.
The obligations provided
for the Member States, such as the obligation to assess, appoint and notify the
conformity assessment bodies are, in any case, not transposed as such into
national law but implemented by the Member States by means of the necessary
regulatory and administrative arrangements. This will not change when the
obligations concerned are set out in a Regulation.
Therefore, Member
States have almost no flexibility in transposing a Directive into their
national law. The choice of a Regulation will however allow them to save the
costs associated with the transposition of a Directive.
Additionally, a Regulation avoids the risk
of possible diverging transpositions of a Directive by the different Member
States, which might lead to different levels of safety protection and create
obstacles to the internal market, undermining thus its effective implementation.
The change from a
Directive to a Regulation will not lead to any change in the regulatory
approach.
The characteristics of
the New Approach will be fully preserved, in particular the flexibility given
to manufacturers in the choice of the means employed to comply with the
essential requirements and in the choice of the procedure used, amongst the
available conformity assessment procedures, to demonstrate compliance of
subsystems and safety components. The existing mechanisms supporting the
implementation of the legislation (standardisation process, working groups,
administrative cooperation, the development of guidance documents etc.) will
not be affected by the nature of the legal instrument.
Furthermore, the choice of a Regulation
does not mean that the decision-making process is centralised. Member States
retain their competence with regard to cableway installations and the
implementation of the harmonised provisions, e.g. the designation and
accreditation of notified bodies, the conduct of market surveillance and
enforcement action (e.g. penalties).
Finally, the use of
Regulations in the area of internal market legislation, allows, in accordance
also with the preference expressed by stakeholders, to avoid the risk of ‘gold
plating’. It also allows manufacturers to work directly with the Regulation
text instead of needing to identify and examine 28 transposition laws.
On this basis, it is
considered that the choice of a Regulation is the most appropriate and less
costly solution for all involved parties as it will allow a more rapid and
coherent application of the proposed legislation and will establish a clearer regulatory
environment for economic operators, while avoiding transposition costs to
Member States.
4.           BUDGETARY IMPLICATION 
This proposal does not have any
implications for the EU budget.
5.           ADDITIONAL INFORMATION
Repeal of existing legislation
The adoption of the proposal will lead to
repeal of Directive 2000/9/EC.
European Economic Area
The proposal concerns the EEA and should
therefore be extended to the European Economic Area.
2014/0107 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
on cableway installations
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 114 thereof,
Having regard to the proposal from the
European Commission,
After transmission of the draft legislative
act to the national Parliaments,
Having regard to the opinion of the
European Economic and Social Committee[10],
Acting in accordance with the ordinary
legislative procedure,
Whereas:
(1)       Directive 2000/9/EC of the
European Parliament and of the Council[11]
on cableway installations lays down rules for cableway installations that are
designed, constructed and operated in view of transporting persons.
(2)       Directive 2000/9/EC is
based on the New Approach principles, as set out in Council Resolution of 5 May
1985 on a new approach to technical harmonisation and standards[12]. Thus, it sets out
only the essential requirements applying to cableway installations, whereas
technical details are adopted by the European Committee for Standardisation
(CEN) and the European Committee for Electrotechnical Standardisation (Cenelec)
in accordance with Regulation (EU) No 1025/2012 of the European Parliament and
of the Council[13]
on European Standardisation. Conformity with the harmonised standards so set,
the reference number of which is published in the Official Journal of the
European Union, provides a presumption of conformity with the requirements
of Directive 2000/9/EC. Experience has shown that those basic principles have
worked well in this sector and should be maintained and even further promoted.
(3)       Experience from the
implementation of Directive 2000/9/EC showed the need to modify some of its
provisions in order to clarify and update them and ensure thus legal certainty
mainly as regards the scope and the conformity assessment of subsystems.
(4)       Decision No 768/2008/EC of
the European Parliament and of the Council[14]
on a common framework for the marketing of products 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 2000/9/EC should therefore be adapted to that Decision.
(5)       As a number of changes are
to be made to Directive 2000/9/EC, it should be repealed and replaced in the
interests of clarity. Since the scope, essential requirements and conformity
assessment procedures must be identical in all Member States, there is almost
no flexibility in transposing a Directive based on the New Approach principles
into national law. In order to simplify the regulatory framework, Directive
2000/9/EC should be replaced by a Regulation, which is the appropriate legal
instrument as it imposes clear and detailed rules which do not give room for
divergent transposition by Member States and ensures thus a uniform
implementation throughout the Union. 
(6)       Regulation (EC) No
765/2008 of the European Parliament and of the Council[15] setting out the
requirements for accreditation and market surveillance relating to the
marketing of products lays down horizontal provisions on the accreditation of
conformity assessment bodies [,on market surveillance of products and controls
on products from third countries] and on the CE marking.
(7)       Regulation (EU) No […/…]
[on market surveillance of products][16]
provides detailed rules on market surveillance and on controls of products
entering the Union from third countries, including subsystems and safety
components. It also sets out a safeguard clause procedure. Member States are to
organise and carry out market surveillance, appoint market surveillance
authorities and specify their powers and duties. They are also to set up general
and sector-specific market surveillance programs.
(8)       The scope of Directive
2000/9/EC should be maintained. This Regulation should apply to cableway
installations designed to transport persons used in high-altitude tourist
resorts or in urban transport facilities. Cableway installations are mainly
lift systems, such as funicular railways, aerial ropeways, cable cars,
gondolas, chairlifts and drag lifts. Traction by cable and the passenger
transport function are the essential criteria determining the cableway
installations covered by this Regulation.
(9)       New types of cableway
installations have been developed that are intended for both transport and
leisure activities. Such installations should be covered by this Regulation.
(10)     It is appropriate to exclude
certain cableway installations from the scope of this Regulation, either
because they are subject to other specific Union harmonisation legislation or
because they can be adequately regulated at national level.
(11)     Cable-operated lifts,
whether vertical or inclined, permanently serving specific levels of buildings
and constructions other than the stations, are subject to specific Union
legislation and should be excluded from the scope of this Regulation.
(12)     In order to ensure legal
certainty, the exclusion of the cable-operated ferries should cover all
cable-operated installations where the users or carriers are water-borne, such
as cable-operated water ski installations.
(13)     In order to ensure that
cableway installations and their infrastructure, subsystems and safety
components guarantee a high level protection of the health and safety of persons
it is necessary to lay down rules for the design and the construction of
cableway installations.
(14)     Member States should ensure
the safety of cableway installations at the time of their construction, entry
into service and during their operation.
(15)     This Regulation does not
affect the right of the Member States to specify the requirements they deem
necessary as regards land-use, regional planning and in order to ensure the
protection of the environment and of the health and safety of persons and in
particular workers when using cableway installations.
(16)     This Regulation does not
affect the right of the Member States to specify adequate procedures for the
authorisation of planned cableway installations, the inspection of cableway
installations prior to their entry into service and their monitoring during
operation.
(17)     This Regulation should take
into account the fact that the safety of cableway installations depends equally
on the surrounding conditions, on the quality of the industrial goods supplied
and on the way in which they are assembled, installed on site and monitored
during operation. The causes of serious accidents may be linked to the choice
of site, to the system of transport itself, to the structures, or to the way in
which the system is operated and maintained.
(18)     Although this Regulation is
not to cover the actual operation of cableway installations, it should provide
a general framework intended to ensure that such installations situated on the territory of Member States, are operated in such a way as to offer users, operating
personnel and third parties a high degree of protection.
(19)     In the case of cableway
installations, technological innovations can be verified and submitted to
full-scale tests only on the occasion of the construction of a new cableway installation.
In these circumstances, a procedure should be provided which, while ensuring
that the essential requirements are complied with, also enables to take into
account the particular conditions of a specific cableway installation.
(20)     Member States should take
the necessary steps to ensure that cableway installations enter into service
only if they comply with this Regulation and they are not liable to endanger
the health and safety of persons or property when properly installed,
maintained and operated in accordance with their intended purpose.
(21)     Member States should lay
down procedures for authorising the construction of planned cableway
installations and the modification of such installations and for their
entry into service in order to ensure that the cableway installation is safely
constructed and assembled on site, in accordance with the safety analysis and
the safety report and all relevant regulatory requirements.
(22)     The safety analysis for
planned cableway installations should identify the components on which the
safety of the cableway installation depends.
(23)     The safety analysis for
planned cableway installations should take into account the constraints linked
to the operation of cableway installations, albeit not in such a way as to
jeopardise the principle of free movement of goods for subsystems and safety
components or the safety of the cableway installations themselves.
(24)     This Regulation should aim
to ensure the functioning of the internal market of subsystems of cableway
installations and of safety components for cableway installations. Subsystems
and safety components complying with the provisions of this Regulation should
benefit from the principle of free movement of goods.
(25)     Subsystems and safety
components should be allowed to be incorporated in a cableway installation
provided that they permit the construction of cableway installations which comply
with this Regulation and are not liable to endanger the health and safety of
persons or property when properly installed, maintained and operated in
accordance with their intended purpose.
(26)     The essential requirements
should be interpreted and applied so as to take account of the state of the art
at the time of design and manufacture as well as of technical and economic
considerations which are consistent with a high degree of health and safety
protection.
(27)     Economic operators should
be responsible for the compliance of subsystems and safety components with the
requirements of this Regulation, in relation to their respective roles in the
supply chain, so as to ensure a high level of protection of public interests,
such as the health and safety of users and other persons and protection of property
and to guarantee fair competition on the Union market.
(28)     All economic operators
intervening in the supply and distribution chain should take appropriate
measures to ensure that they only make available on the market subsystems and
safety components which are in conformity with this Regulation. It is necessary
to provide for a clear and proportionate distribution of obligations which
correspond to the role of each economic operator in the supply and distribution
chain.
(29)     The manufacturer of
subsystems and safety components, 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 solely the
obligation of the manufacturer of the subsystem or the safety component.
(30)     In order to facilitate the
communication between economic operators and national market surveillance
authorities, Member States should encourage economic operators to include a
website address in addition to the postal address.
(31)     It is necessary to ensure
that subsystems and safety components from third countries entering the Union
market comply with the requirements of this Regulation, and in particular that
appropriate conformity assessment procedures have been carried out by
manufacturers with regard to those subsystems and safety components. Provision
should therefore be made for importers to make sure that the subsystem or
safety component they place on the market comply with the requirements of this
Regulation and that they do not place on the market subsystems and safety
components 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 subsystem and safety component marking
and documentation drawn up by manufacturers are available for inspection by the
competent supervisory authorities.
(32)     The distributor makes a
subsystem or a safety component 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 subsystem or the safety component does
not adversely affect its compliance.
(33)     When placing on the market
a subsystem or a safety component, every importer should indicate on the subsystem
or safety component his name, registered trade name or registered trade mark and
the postal address at which he can be contacted. Exceptions should be provided
for in cases where the size or nature of the safety component does not allow
it. This includes cases where the importer would have to open the packaging to
put his name and address on the safety component.
(34)     Any economic operator that
either places a subsystem or a safety component on the market under his own
name or trademark or modifies a subsystem or a safety component in such a way
that compliance with the requirements of this Regulation may be affected should
be considered to be the manufacturer and should assume the obligations of the
manufacturer.
(35)     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 authorities with all necessary
information relating to the subsystems or the safety components concerned.
(36)     Ensuring traceability of a
subsystem or safety component 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 subsystems or safety components available on
the market.
(37)     This Regulation should be limited
to the expression of the essential requirements. In order to facilitate
conformity assessment with those requirements it is necessary to provide for
presumption of conformity for cableway installations which are in conformity
with harmonised standards that are adopted in accordance with Regulation (EU)
No 1025/2012 for the purpose of expressing detailed technical specifications of
those requirements, especially with regard to the design, construction and operation
of cableway installations.
(38)     Regulation (EU) No
1025/2012 provides for a procedure for objections to harmonised standards where
those standards do not entirely satisfy the requirements of this Regulation.
(39)     In order to enable economic
operators to demonstrate and the competent authorities to ensure that subsystems
and safety components made available on the market conform to the essential
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.
(40)     Manufacturers of subsystems
or safety components should draw up an EU declaration of conformity to provide information
required under this Regulation on the conformity of subsystem or safety
component with the requirements of this Regulation and of other relevant Union
harmonisation legislation. The EU declaration of conformity should accompany
the subsystem or safety component.
(41)     To ensure effective access
to information for market surveillance purposes, the information required to
identify all applicable Union acts for a subsystem or a safety component should
be available in a single EU declaration of conformity.
(42)     The CE marking, indicating
the conformity of a subsystem or a safety component is the visible consequence
of a whole process comprising conformity assessment in a broad sense. General
principles governing the CE marking and its relationship with other markings are
set out in Regulation (EC) No 765/2008. Rules governing the affixing of the CE
marking should be laid down in this Regulation.
(43)     A check of compliance of subsystems
and safety components with the essential requirements provided for in this
Regulation is necessary in order to provide effective protection for users and
third parties.
(44)     In order to ensure
compliance of subsystems and safety components with the essential requirements,
it is necessary to lay down appropriate conformity assessment procedures to be
followed by the manufacturer. Those procedures should be set on the basis of the
conformity assessment modules laid down in Decision No 768/2008/EC.
(45)     The conformity assessment
procedures set out in this Regulation require the intervention of conformity
assessment bodies, which are notified by the Member States to the Commission.
(46)     Experience has shown that
the criteria set out in Directive 2000/9/EC that conformity assessment bodies have
to fulfil in order to be notified to the Commission are not sufficient to
ensure a uniformly high level of performance of these bodies throughout the Union. It is, however, essential that all conformity assessment 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.
(47)     In order to ensure a
consistent level of conformity assessment quality, it is also necessary to set
requirements for notifying authorities and other bodies involved in the
assessment, notification and monitoring of notified bodies.
(48)     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 Regulation.
(49)     The system set out in this Regulation
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.
(50)     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 that 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.
(51)     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 subsystems and safety
components 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.
(52)     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.
(53)     Since conformity assessment
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.
(54)     In the interests of
competitiveness, it is crucial that conformity assessment 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 needs to be ensured. That can best be achieved through
appropriate coordination and cooperation between conformity assessment bodies.
(55)     In order to ensure uniform
conditions for the implementation of this Regulation, implementing powers
should be conferred to the Commission. Those powers should be exercised in
accordance with Regulation (EU) No 182/2011 of the European Parliament and of
the Council[17].
(56)     The advisory procedure
should be used for the adoption of implementing acts requesting the notifying Member State to take the necessary corrective measures in respect of notified bodies that
do not meet or no longer meet the requirements for their notification.
(57)     It is necessary to provide
for transitional arrangements that allow the making available on the market and
the putting into service of subsystems and safety components that have already
been placed on the market in accordance with Directive 2000/9/EC.
(58)     It is necessary to provide
for transitional arrangements that allow the entry into service of cableway
installations that have already been constructed in accordance with Directive
2000/9/EC.
(59)     Member States should lay
down rules on penalties applicable to infringements to this Regulation and
ensure that they are implemented. Those penalties must be effective, proportionate
and dissuasive.
(60)     Since the objective of this
Regulation, namely to ensure that cableway installations fulfil the
requirements providing for a high level protection of and safety of users while
guaranteeing the functioning of the internal market for subsystems and safety
components 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 Regulation does not go beyond what is necessary in order to achieve that
objective.
HAVE ADOPTED THIS REGULATION:
CHAPTER I
            GENERAL PROVISIONS
Article 1
Subject
matter
This Regulation lays down rules on the
design and construction of cableway installations designed to transport persons
and on the making available on the market and the free movement of subsystems
and safety components for such installations.
Article 2
Scope
(1)                   
This Regulation shall apply to cableway
installations designed to transport persons and to subsystems and safety components for such installations.
(2)                   
This Regulation shall not apply to the following:
(a)         
lifts within the meaning of Directive 95/16/EC of
the European Parliament and of the Council[18]
on lifts;
(b)         
cable-operated tramways of traditional construction;
(c)         
installations intended for agricultural purposes
and for the service of mountain shelters and huts that are not intended for the
transport of the public;
(d)        
on-site or mobile equipment for use in
fairgrounds and/or amusement parks which are exclusively designed for leisure purposes and not as a means for transporting persons;
(e)         
mining installations or other industrial on site installations
used for industrial activities;
(f)          
installations in which the users or their
carriers are water-borne.
Article 3
Definitions
For the
purposes of this Regulation the following definitions shall apply:
(1)                   
"cableway installation" means the
whole on site system, consisting of infrastructure and subsystems intended for installations
made up of several components, designed, constructed, assembled and put into
service with the object of transporting persons, where the traction is provided
by cables positioned along the line of travel;
(2)                   
"subsystem" means
the systems listed in Annex I as such or a combination thereof;
(3)                   
"infrastructure"
means the layout, system data, station structures and structures along the line
especially designed for each installation and constructed on site and which are
needed for the construction and the operation of the installation, including
the foundations;
(4)                   
"safety component"
means any basic component, set of components, subassembly
or complete assembly of equipment and any device intended to be incorporated in
a subsystem or a cableway installation for the purpose of ensuring a safety
function, the failure of which endangers the safety or health of persons,
users, operating personnel or third parties;
(5)                   
"operability" means
all the technical provisions and measures which have an impact on design and construction and are necessary in order for
the cableway installation to operate safely;
(6)                   
"maintainability" means all the technical provisions and measures which have an impact on
design and construction and are
necessary for maintenance, designed to ensure that the cableway installation
operates safely;
(7)                   
"cable car" means a cableway installation where the carriers are suspended
from one or more cables;
(8)                   
"drag lift" means a cableway installation
where users with appropriate equipment are towed along a prepared track;
(9)                   
"funicular railway" means a cableway
installation in which the carriers are hauled along rails that are on the
ground or supported by fixed structures;
(10)               
"making available
on the market" means any supply of a subsystem or a safety component for
distribution 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 subsystem or a safety component on the Union
market;
(12)               
"entry into service" means the initial
operation of a cableway installation;
(13)               
"manufacturer" means any natural or
legal person who manufactures a subsystem or a safety component or who has such
a subsystem or a safety component designed or manufactured, and markets that subsystem
or safety component under his name or trademark;
(14)               
"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;
(15)               
"importer" means any natural or legal
person established within the Union who places a subsystem or a safety
component from a third country on the Union market;
(16)               
"distributor" means any natural or
legal person in the supply chain, other than the manufacturer or the importer,
who makes a subsystem or a safety component available on the market;
(17)               
"economic operators" means the
manufacturer, the authorised representative, the importer and the distributor of
a subsystem or a safety component;
(18)               
"technical specification" means a
document that prescribes technical requirements to be fulfilled by an installation,
infrastructure, subsystem or safety component;
(19)               
"harmonised standard" means harmonised
standard as defined in Article 2(1)(c) of Regulation (EU) No 1025/2012;
(20)               
"accreditation" means accreditation as
defined in Article 2(10) of Regulation (EC) No 765/2008;
(21)               
"national accreditation body" means
national accreditation body as defined in Article 2(11) of Regulation (EC) No
765/2008;
(22)               
"conformity assessment" means the
process demonstrating whether the essential requirements of this Regulation relating
to a subsystem or safety component have been fulfilled;
(23)               
"conformity assessment body" means a
body that performs conformity assessment activities relating to a subsystem or
safety component, including calibration, testing, certification and inspection;
(24)               
"recall" means any measure aimed at
achieving the return of a subsystem or a safety component that has already been
incorporated into a cableway installation;
(25)               
"withdrawal" means any measure aimed
at preventing a subsystem or a safety component in the supply chain from being
made available on the market;
(26)               
"CE marking" means a marking by which
the manufacturer indicates that the subsystem or the safety component is in
conformity with the applicable requirements set out in Union harmonisation
legislation providing for its affixing;
(27)               
"Union harmonisation legislation"
means any Union legislation harmonising the conditions for the marketing of
products.
Article 4
Making
available on the market of subsystems and safety components
(1)                   
Member States shall take all appropriate
measures to ensure that subsystems and safety components are made available on the
market only if they satisfy the requirements of this Regulation.
(2)                   
Member States shall take all appropriate
measures, in accordance with Article 9, to determine the procedures to ensure
that the subsystems and safety components are incorporated into cableway
installations only if they enable the construction of cableway installations
which satisfy the requirements of this Regulation and are not liable to endanger
the health and safety of persons or property when properly incorporated,
maintained and operated in accordance with their intended purpose.
Article 5
Entry into service of cableway installations
(1)                   
Member States shall take all appropriate
measures in accordance with Article 9, to determine the procedures to ensure that
cableway installations enter into service only if they satisfy the requirements
of this Regulation and they are not liable to endanger the health and safety of
persons or property when properly installed, maintained and operated in
accordance with their intended purpose.
(2)                   
Cableway
installations 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 requirements covered
by those standards or parts thereof, referred to in Annex II.
(3)                   
This Regulation shall not affect Member States' entitlement
to lay down such requirements as they may deem necessary to ensure that persons
and, in particular, workers are protected when using the cableway installations
in question, provided that this does not mean that the cableway installations
are modified in a way not specified in this Regulation.
Article 6
Essential
requirements
The cableway installations and their
infrastructure, subsystems and safety components shall satisfy the essential
requirements applicable to them set out in Annex II.
Article 7
Free
movement of subsystems and safety components
Member States shall not prohibit, restrict
or impede the making available on the market of subsystems and safety components
which comply with this Regulation.
Article 8
Safety
analysis and safety report for planned cableway installations
(1)                   
All planned installations shall be subject to a
safety analysis as defined in Annex III which shall cover all safety aspects of
the cableway installation and its environment in the context of the design, construction
and entry into service and shall make it possible to identify from past
experience risks liable to occur during the operation of the cableway
installation.
(2)                   
The safety analysis shall be included in a
safety report. That report shall recommend the measures envisaged to deal with
such risks and include a list of the subsystems and safety components to be
incorporated into the cableway installation.
Article 9
Authorisation
of cableway installations
(1)                   
Member States shall lay down procedures
for authorising the construction and the entry into service of cableway installations
which are located within its territory.
(2)                   
Member States shall ensure that the safety
analysis, the safety report, the EU declaration of conformity and the other
documents relating to the conformity of subsystems and safety components as well
as the documentation concerning the characteristics of the cableway
installation are submitted to the authority responsible for approving the
cableway installation. The documentation concerning the cableway installation shall
also include the necessary conditions, including the restrictions on operation,
and full details for servicing supervision, adjustment and maintenance
of the cableway installation. A copy of those documents shall be kept at the
cableway installation.
(3)                   
In the event that important characteristics, subsystems or safety components of existing cableway installations
undergo modifications for which a new authorisation for entry into service is
required by the Member State concerned, such modifications and their
repercussions on the cableway installation as a whole shall satisfy the
essential requirements set out in Annex II.
(4)                   
Member States shall not use the provisions referred
to in paragraph 1 to prohibit, restrict or hinder, on grounds related to the
aspects covered by this Regulation, the construction and the entry into service
of cableway installations which comply with this Regulation and do not
present a risk to the health and safety of persons or to property
when properly installed in accordance with their intended purpose.
(5)                   
Member States shall not use the provisions
referred to in paragraph 1 to prohibit, restrict or hinder the free movement of
subsystems and safety components which comply with this Regulation.
Article 10
Operation
of cableway installations
(1)                   
Member States shall ensure that a cableway installation
remains in operation only if it complies with the conditions set out in
the safety report.
(2)                   
If a Member State finds that an approved
cableway installation which is used in accordance with its intended purpose is
liable to endanger the health and safety of persons and, where appropriate,
property, it shall take all appropriate measures to restrict the conditions of
operation of the cableway installation or to prohibit the operation
thereof.
CHAPTER II
OBLIGATIONS OF ECONOMIC OPERATORS OF
SUBSYSTEMS AND SAFETY COMPONENTS
Article 11 [Article R2 of Decision No
768/2008/EC]
Obligations
of manufacturers
(1)                   
When placing their subsystems or safety
components on the market, manufacturers shall ensure that they have been
designed and manufactured in accordance with the essential requirements set out
in Annex II.
(2)                   
Manufacturers of subsystems or safety components
shall draw up the technical documentation set out in Annex V and carry out the relevant
conformity assessment procedure referred to in Article 18 or have it
carried out.
Where compliance of a subsystem or a safety
component with the applicable requirements has been demonstrated by the
procedure referred to in the first subparagraph, manufacturers shall draw up an
EU declaration of conformity and affix the CE marking.
(3)                   
Manufacturers shall keep the technical
documentation and the EU declaration of conformity for 30 years after the subsystem
or the safety component has been placed on the market.
(4)                   
Manufacturers shall ensure that procedures are
in place for series production to remain in conformity with this Regulation.
Changes in subsystem or safety component design or characteristics and changes
in the harmonised standards or in other technical specifications by reference
to which the conformity of the subsystem or the safety component is declared
shall be adequately taken into account.
When deemed appropriate with regard to the risks
presented by a subsystem or a safety component, manufacturers shall, to protect
the health and safety of users, carry out sample testing of the subsystem or
the safety component made available on the market, investigate, and, if
necessary, keep a register of complaints of non-conforming subsystems or safety
components and recalls of such subsystems or safety components, and shall keep
distributors informed of any such monitoring.
(5)                   
Manufacturers shall ensure that their subsystems
or safety components are accompanied by the EU declaration of conformity and
that they bear a type, batch or serial number or other element allowing their
identification.
Where the size or nature of the safety
component does not allow it, manufacturers shall ensure that the required
information is provided on the packaging or in the instructions accompanying
the safety component.
(6)                   
Manufacturers shall indicate on the subsystem or
the safety component their name, registered trade name or registered trade mark
and the postal address at which they can be contacted or, where that is not
possible, on the packaging and in the instructions accompanying the safety
component. The address shall indicate a single point at which the manufacturer
can be contacted. The contact details shall be in a language easily understood
by users and the market surveillance authorities as determined by the Member State concerned.
(7)                   
Manufacturers shall ensure that the subsystem or
the safety component is accompanied by the EU Declaration of conformity and by instructions
and safety information, in a language which can be easily understood by users, as
determined by the Member State concerned. Such instructions and safety
information shall be clear, understandable and intelligible.
(8)                   
Manufacturers who consider or have reason to
believe that the a subsystem or a safety component which they have placed on
the market is not in conformity with this Regulation shall immediately take the
necessary corrective measures necessary to bring that subsystem or safety
component into conformity, to withdraw it or recall it, if appropriate.
Furthermore, where the subsystem or the safety component presents a risk,
manufacturers shall immediately inform the competent national authorities of
the Member States in which they made the subsystem or the safety component available
on the market 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 subsystem
or the safety component with this Regulation, in a language which can be easily
understood by that authority. That information and documentation may be
provided in paper or electronic form. They shall cooperate with that authority,
at its request, on any action taken to eliminate the risks posed by the subsystems
or safety components which they have placed on the market. 
Article 12 [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 11(1) and
the obligation to draw 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 30 years after the subsystem or the safety component 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 the subsystem or the safety
component;
(c)         
cooperate with the competent national
authorities, at their request, on any action taken to eliminate the risks posed
by subsystems or safety components covered by the authorised representative’s
mandate.
Article 13 [Article R4 of Decision No
768/2008/EC]
Obligations
of importers
(1)                   
Importers shall place only compliant subsystems
or safety components on the market.
(2)                   
Before placing on the market a subsystem or a
safety component, importers shall ensure that the appropriate conformity
assessment procedure in accordance with Article 18 has been carried out
by the manufacturer. They shall ensure that the manufacturer has drawn up the
technical documentation, that the subsystem or the safety component is accompanied
by the EU declaration of conformity, that it bears the CE marking and is
accompanied by instructions and safety information and that the manufacturer
has complied with the requirements set out in Article 11(5) and (6) respectively.
Where an importer considers or has reason to
believe that a subsystem or a safety component is not in conformity with the
essential requirements set out in Annex II, he shall not place the subsystem or
the safety component on the market until it has been brought into conformity.
Furthermore, where the subsystem or the safety component presents a risk, the
importer shall inform the manufacturer and the market surveillance authorities
to that effect.
(3)                   
Importers shall indicate their name, registered
trade name or registered trade mark and the postal address at which they can be
contacted on the subsystem or the safety component or where that is not
possible, on its packaging and in the instructions accompanying the safety
component. The contact details shall be in a language easily understood by users
and market surveillance authorities as determined by the Member State concerned.
(4)                   
Importers shall ensure that the subsystem or the
safety component is accompanied by instructions and safety information, in
a language which can be easily understood by users, as determined by the Member State concerned.
(5)                   
Importers shall ensure that, while a subsystem
or a safety component is under their responsibility, storage or transport
conditions do not jeopardise their compliance with the requirements set out in
Annex II.
(6)                   
When deemed appropriate with regard to the risks
presented by a subsystem or a safety component, importers shall, to protect
the health and safety of the users, upon a duly justified request of the
competent authorities, carry out sample testing of subsystems or safety
components made available on the market, investigate, and, if necessary, keep a
register of complaints of nonconforming subsystems or safety components and
recalls of such subsystems or safety components, and shall keep distributors
informed of any such monitoring.
(7)                   
Importers who consider or have reason to believe
that a subsystem or a safety component which they have placed on the market is
not in conformity with this Regulation shall immediately take the corrective
measures necessary to bring that subsystem or safety component into conformity,
to withdraw it or recall it, if appropriate. Furthermore, where the subsystem
or the safety component presents a risk, importers shall immediately inform the
competent national authorities of the Member States in which they made the subsystem
or the safety component available on the market to that effect, giving details,
in particular, of the non-compliance and of any corrective measures taken.
(8)                   
Importers shall, for 30 years after the subsystem
or the safety component 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.
(9)                   
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 subsystem or a safety component in
a language which can be easily understood by that authority. That information
and documentation may be provided in paper or electronic form. They shall
cooperate with that authority, at its request, on any action taken to eliminate
the risks posed by subsystems or safety components which they have placed on
the market. 
Article 14 [Article R5 of Decision No
768/2008/EC]
Obligations
of distributors
(1)                   
When making a subsystem or a safety component available
on the market distributors shall act with due care in relation to the
requirements of this Regulation.
(2)                   
Before making a subsystem or a safety component available
on the market distributors shall verify that the subsystem or the safety
component bears the CE marking and it is accompanied by the EU declaration of
conformity and by instructions and safety information in a language which can
be easily understood by users as determined by the Member State concerned, and
that the manufacturer and the importer have complied with the requirements set
out in Article 11(5) and (6) and Article 13(3).
Where a distributor considers or has reason to
believe that a subsystem or a safety component is not in conformity with the
essential requirements set out in Annex II, he shall not make the subsystem or the
safety component available on the market until it has been brought into
conformity. Furthermore, where the subsystem or the safety component 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
subsystem or a safety component is under their responsibility, storage or
transport conditions do not jeopardise its compliance with the essential
requirements set out in Annex II.
(4)                   
Distributors who consider or have reason to
believe that a subsystem or a safety component which they have made available
on the market is not in conformity with this Regulation shall make sure that
the corrective measures necessary to bring that subsystem or safety component into
conformity, to withdraw it or recall it, if appropriate, are taken.
Furthermore, where the subsystem or the safety component presents a risk, distributors
shall immediately inform the competent national authorities of the Member
States in which they made the subsystem or the safety component 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
subsystem or a safety component. That information and documentation may be
provided in paper or electronic form. They shall cooperate with that authority,
at its request, on any action taken to eliminate the risks posed by the subsystem
or the safety component which they have made available on the market.
Article 15 [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 Regulation and he shall be
subject to the obligations of the manufacturer under Article 11, where he
places a subsystem or a safety component on the market under his name or
trademark or modifies a subsystem or a safety component already placed on the
market in such a way that compliance with the requirements of this Regulation
may be affected.
Article 16 [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:
(a)                   
any economic operator who has supplied them with
a subsystem or a safety component;
(b)                   
any economic operator to whom they have supplied
a subsystem or a safety component.
Economic operators shall be able to present
the information referred to in the first paragraph for a period of 30 years
after they have been supplied with the subsystem or the safety component and
for a period of 30 years after they have supplied the subsystem or the safety
component.
CHAPTER III
CONFORMITY OF SUBSYSTEMS AND SAFETY COMPONENTS 
Article 17 [Article R8 of Decision No
768/2008/EC]
Presumption
of conformity
Subsystems and safety components 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
requirements covered by those standards or parts thereof, set out in
Annex II. 
Article 18
Conformity
assessment
(1)                   
Before a subsystem or a safety component
is placed on the market, the manufacturer shall submit the subsystem or the
safety component to a conformity assessment procedure in accordance with
paragraph 2.
(2)                   
The means of certification of conformity of
subsystems and safety components shall be, at the choice of the manufacturer, any
of the following conformity assessment procedures:
(a)         
EU-type examination (Module B – production type)
set out in Annex IV combined with either of the following:
(i)      conformity to type based on quality
assurance of the production process (Module D), set out in Annex V;
(ii)     conformity to type based on subsystem
or safety component verification (Module F), set out in Annex VI.
(b)         
conformity based on unit verification (Module
G), set out in Annex VII.
(c)         
conformity based on full quality assurance
(Module H), set out in Annex VIII.
(3)                   
After completion of the procedures referred to
in paragraph 2, the manufacturer shall, in accordance with Article 21, affix
the CE marking on the subsystem or the safety component that complies with this
Regulation.
(4)                   
Paragraphs 1, 2 and 3 shall also apply with
regard to subsystems and safety components intended for the manufacturer's own purposes.
(5)                   
Records and correspondence relating to
conformity assessment shall be drawn up in the official language(s) of the Member State where the body carrying out the procedures referred to in paragraph 2 is
established or in a language accepted by that body.
Article 19
EU
declaration of conformity
(1)                   
The EU declaration of conformity for a subsystem
or a safety component shall state that the fulfilment of essential requirements
set out in Annex II has been demonstrated.
(2)                   
The EU declaration of conformity shall have the
model structure set out in Annex X and shall contain the elements specified in
the relevant conformity assessment procedures set out in Annexes IV to VIII and
shall be continuously updated. It shall accompany the subsystem or the safety
component and shall be translated into the language or languages required by
the Member State in whose market the subsystem or the safety component is
placed or made available on the market.
(3)                   
Where a subsystem or a safety component is
subject to more than one Union acts 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 Union acts
concerned including their publication references. 
(4)                   
By drawing up the EU declaration of conformity,
the manufacturer shall assume responsibility for the compliance of the subsystem
or the safety component with the requirements laid down in this Regulation. 
Article 20 [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 21 [Article R12 of Decision No 768/2008/EC]
Rules
and conditions for the affixing of the CE marking
(1)                   
The CE marking shall be affixed visibly, legibly
and indelibly to the subsystem or the safety component or to their data plate.
(2)                   
The CE marking shall be affixed before the subsystem
or the safety component is placed on the market.
(3)                   
The CE marking shall be followed by the
identification number of the notified body involved in the production control
phase.
(4)                   
The CE marking and the identification number
referred to in paragraph 3 may be followed by any other mark indicating a
special risk or use.
CHAPTER IV
NOTIFICATION
OF CONFORMITY ASSESSMENT BODIES
Article 22 [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 in accordance with Article 18.
Article 23 [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 Article 26.
(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 26(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 24 [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 25 [Article R16 of Decision No 768/2008/EC]
Information
obligation of 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 26 [Article R17 of Decision No 768/2008/EC]
Requirements
relating to notified bodies
(1)                   
For the purposes of notification, a notified
body shall meet the requirements laid down in paragraphs 2 to 11.
(2)                   
A conformity assessment body shall be
established under national law of a Member State and have legal personality.
(3)                   
A conformity assessment body shall be a third-party
body independent of the organisation or the subsystem or the safety component 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 subsystems or safety
components 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 subsystems or the safety components
which they assess, nor the representative of any of those parties. This shall
not preclude the use of assessed subsystems or safety components that are
necessary for the operations of the conformity assessment body or the use of
such subsystems or safety components 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 subsystems
or safety components, 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 IV
to VIII .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 subsystems or safety components 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 subsystem or safety
component technology in question and the mass or serial nature of the
production process.
A conformity assessment body shall have the
means necessary to perform the technical and administrative tasks connected
with the conformity assessment tasks 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 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 personnel responsible for
carrying out the conformity assessment tasks shall be guaranteed.
The remuneration of the top level management
and of the personnel responsible for carrying out the conformity assessment
tasks 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 IV to VIII or any provision of national
law giving effect to them, 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 personnel responsible for carrying out the conformity
assessment tasks are informed of, the relevant standardisation activities and
the activities of the notified body coordination group established under this
Regulation and shall apply as general guidance the administrative decisions and
documents produced as a result of the work of that group.
Article 27 [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 26 in so far as the applicable
harmonised standards cover those requirements. 
Article 28 [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 26 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 IV to VIII.
Article 29 [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)                   
The application for notification shall be
accompanied by a description of the conformity assessment activities, the
conformity assessment module or modules and the subsystem/safety component or subsystems/safety
components 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 26.
(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 26.
Article 30 [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
26.
(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 the subsystem/safety component or subsystems/safety components concerned
and the relevant attestation of competence.
(4)                   
Where a notification is not based on an
accreditation certificate as referred to in Article 29(2), the notifying
authority shall provide the Commission and the other Member States with
documentary evidence which attests 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
26.
(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 Regulation.
(6)                   
The Commission and the other Member States shall be notified of any subsequent relevant changes to the notification. 
Article 31 [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 notified bodies under this Regulation, including the identification
numbers that have been assigned to them and the activities for which they have
been notified.
The Commission shall ensure that that list is
kept up to date.
Article 32 [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 26 or that it is failing to fulfil its obligations, the
notifying authority shall, as appropriate, restrict, suspend or withdraw the
notification, 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 33 [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 notified 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 adopt an implementing act requesting the notifying Member State to take the necessary corrective measures, including withdrawal of notification if
necessary.
The implementing act referred to in the first
subparagraph shall be adopted in accordance with the advisory procedure
referred to in Article 39(2).
Article 34 [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 IV to VIII.
(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 subsystem
or safety component 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
subsystem or the safety component with the provisions of this Regulation.
(3)                   
Where a notified body finds that essential
requirements set out in Annex II or corresponding harmonised standards or other
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
subsystem or a safety component no longer complies, 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 35
Appeal
against decisions of notified bodies
Member States shall ensure that an appeal
procedure against decisions of notified bodies is available.
Article 36 [Article R28 of Decision No 768/2008/EC]
Information
obligation of 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 or the 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 Regulation carrying out similar conformity assessment
activities covering the same subsystems or safety components with relevant information
on issues relating to negative and, on request, positive conformity assessment
results.
Article 37 [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 38 [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 Regulation
are put in place and properly operated in the form of a sectoral group or
groups of notified
bodies.
Member States shall ensure that the bodies
notified by them participate in the work of that or those group or groups,
directly or by means of designated representatives.
CHAPTER V
COMMITTEE
PROCEDURE, TRANSITIONAL AND FINAL PROVISIONS
Article 39
Committee
procedure
(1)                   
The Commission shall be assisted by the
Committee on cableway installations. That committee shall be a committee within
the meaning of Regulation (EU) No 182/2011.
(2)                   
Where reference is made to this paragraph, Article
4 of Regulation (EU) No 182/2011 shall apply.
Article 40
Penalties
The Member States shall lay down the rules on
penalties applicable to infringements by economic operators of the provisions
of this Regulation and shall take all measures necessary to ensure that they are
enforced. Such rules may include criminal penalties for serious infringements.
The penalties provided for shall be
effective, proportionate and dissuasive.
The Member States shall notify those
provisions to the Commission by [3 months prior to the date referred to in
Article 43(2)] and shall notify it without delay of any subsequent amendment
affecting them.
Article 41
Transitional
provisions
Member States shall not impede the making
available on the market of subsystems or safety components covered by Directive
2000/9/EC which are in conformity with that Directive and which were placed on
the market before [the date referred to in Article 43(2)].
Member States shall not impede the entry into
service of cableway installations covered by Directive 2000/9/EC which are in
conformity with that Directive and which were constructed before [the date
referred to in Article 43(2)].
Article 42
Repeal
Directive 2000/9/EC is repealed from [the
date referred to in Article 43(2)].
References to the repealed Directive shall
be construed as references to this Regulation and shall be read with in
accordance with the correlation table laid down in Annex X.
Article 43
Entry
into force and date of application
(1)                   
This Regulation shall enter into force on the
twentieth day following that of its publication in the Official Journal of the
European Union.
(2)                   
It shall apply from [two years after entry into
force].
(3)                   
By way of derogation from paragraph 2, Articles
22 to 38 shall apply from [six months after entry into force].
This Regulation shall be binding
in its entirety and directly applicable in all Member States.
Done at Brussels,
For the European Parliament                        For
the Council
The President                                                 The
President
[1]               OJEU L 106, 3.5.2000, p.21.
[2]               COM(2013)471 final. 
[3]               OJEU L 316, 14.11.2012. 
[4]               Proposal for a Regulation of the European Parliament
and of the Council on market surveillance of products 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, 1999/5/EC, 2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC,
2006/42/EC, 2006/95/EC, 2007/23/EC, 2008/57/EC, 2009/48/EC, 2009/105/EC,
2009/142/EC, 2011/65/EU, Regulation (EU) No 305/2011, Regulation (EC) No
764/2008 and Regulation (EC) No 765/2008 of the European Parliament and of the
Council. COM(2013) 75 final.
[5]               OJ L11, 15.1.2002, p.4.
[6]               OJ L218, 13.8.2008, p.30.
[7]               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.
[8]               Report from the Commission to the European Parliament
and the Council, COM(2011) 123 final, 16.3.2011.
[9]               OJ L213, 7.9.1995, p.1.
[10]             OJ C […], […], p. […].
[11]             Directive 2000/9/EC of the European Parliament and of
the Council of 20 March 2000 relating to cableway installations designed to
carry persons (OJ L 106, 3.5.2000, p.21).
[12]             OJ C 136, 4.6.1985, p.1.
[13]             Regulation (EU) No 1025/2012 of
the European Parliament and of the Council of 25 October 2012 on European
Standardisation, 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, 2009/23/EC and 2009/105/EC of the European Parliament and of the
Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC
of the European Parliament and of the Council (OJ L 316, 14.11.2012, p.12).
[14]             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 (OJ L 218, 13.8.2008, p.82).
[15]             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 (OJ L 218, 13.8.2008, p.30).
[16]             OJ L […...].
[17]             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 (OJ
L 55, 28.2.2011, p.13).
[18]             Directive 95/16/EC of the European
Parliament and of the Council of 29 June 1995 on the approximation of the laws
of the Member States relating to lifts (OJ L 213, 7.9.1995, p.1).
ANNEX I
SUBSYSTEMS
A cableway installation is divided up into infrastructure and the subsystems listed below, with
exploitability and maintainability having to be taken
into account in each case:
1.         Cables and cable connections.
2.         Drives and brakes.
3.         Mechanical equipment:
3.1.      Cable winding gear.
3.2.      Station machinery.
3.3.      Line engineering.
4.         Vehicles:
4.1.      Cabins, seats or drag devices.
4.2.      Suspension gear.
4.3.      Driving gear.
4.4.      Connections to the cable.
5.         Electrotechnical devices:
5.1.      Monitoring, control and safety
devices.
5.2.      Communication and information
equipment.
5.3.      Lightning protection equipment.
6.         Rescue equipment:
6.1.      Fixed rescue equipment.
6.2.      Mobile rescue equipment.
ANNEX II
ESSENTIAL
REQUIREMENTS
1. Purpose
This Annex sets out the essential requirements, including
maintainability and operability, applicable to the design, construction and
entry into service of cableway installations.
2. General requirements
2.1. Safety of persons
The safety of users, workers and third parties is a
fundamental requirement for the design, construction and operation of cableway
installations.
2.2. Principles of safety
All cableway installations shall be designed, operated and
serviced in accordance with the following principles, which are to be applied
in the order given:
–                        
eliminate or, if that is not possible, reduce risks
by means of design and construction features,
–                        
define and implement all necessary measures to
protect against risks which cannot be eliminated by the design and construction
features,
–                        
define and state the precautions which should be
taken to avoid the risks which it has not been possible to eliminate completely
by means of the provisions and measures referred to in the first and second
indents.
2.3. Consideration of
external factors
Cableway installations must be so designed and constructed
as to make it possible to operate them safely, taking into account the type of
cableway installation, the nature and physical features of the terrain
on which it is installed, its surroundings and atmospheric and meteorological
factors, as well as possible structures and obstacles located in the vicinity
either on the ground or in the air.
2.4. Dimensions
The cableway installation, the subsystems and all its
safety components shall be dimensioned, designed and constructed to withstand,
with a sufficient degree of safety, all stresses encountered under all
foreseeable conditions, including those which occur when not in operation, and
taking account in particular of outside influences, dynamic effects and fatigue
phenomena, while complying with the acknowledged rules of the art, in
particular with regard to the choice of materials.
2.5. Assembly
2.5.1. The cableway installation, the subsystems and all
the safety components shall be designed and constructed in such a way as to
ensure that they can be safely assembled and put into place.
2.5.2. The safety components shall be so designed as to
make assembly mistakes impossible, either as a result of construction or by
means of appropriate markings on the components themselves.
2.6. Integrity of the
cableway installation
2.6.1. The safety components shall be designed and
constructed and be usable in such a way as to ensure that, in every case, their
own operational integrity and/or the safety of the cableway installation is
ensured, as defined in the safety analysis in Annex III, so that their failure
is highly improbable and with an adequate safety margin.
2.6.2. The cableway installation shall be designed and
constructed in such a way as to ensure that, during its operation, any failure
of a component which might affect safety, even indirectly, is met by an
appropriate measure being taken in good time.
2.6.3. The safeguards referred to in points 2.6.1 and 2.6.2
shall apply throughout the period between two scheduled inspections of the
component concerned. The time period for the scheduled inspection of the safety
components shall be clearly indicated in the instruction manual.
2.6.4. Safety components which are incorporated into
cableway installations as spare parts shall satisfy the essential requirements
of this Regulation and the conditions relating to the smooth interaction with
the other parts of the cableway installations.
2.6.5. Measures shall be taken to ensure that the effects
of a fire in the cableway installation do not endanger the safety of persons
being transported and workers.
2.6.6. Special measures shall be taken to protect cableway
installations and persons from the effects of lightning.
2.7. Safety devices
2.7.1. Any defect in the cableway installation which could
result in a failure endangering safety shall, where practicable, be detected,
reported and processed by a safety device. The same applies to any normally
foreseeable external event which may endanger safety.
2.7.2. It shall be possible at all times to shut down the
cableway installation manually.
2.7.3. After the cableway installation has been shut down
by a safety device, it shall not be possible to restart it unless appropriate
action has been taken.
2.8. Maintainability
The cableway installation shall be designed and constructed
so as to enable routine or special maintenance and repair operations and
procedures to be carried out safely.
2.9. Nuisance
The cableway installation shall be designed and constructed
in such a way as to ensure that any internal or external nuisance resulting
from noxious gases, noise emissions or vibrations falls within the prescribed
limits.
3. Infrastructure requirements
3.1. Layout, speed, distance
between vehicles
3.1.1. The cableway installation shall be designed to
operate safely taking into account the characteristics of the terrain and its
surroundings, atmospheric and meteorological conditions, any possible
structures and obstacles located in the vicinity either on the ground or in the
air in such a way as to cause no nuisance or pose no danger under any
operational or servicing conditions or in the event of an operation to rescue
persons.
3.1.2. Sufficient distance shall be maintained laterally
and vertically between vehicles, towing devices, tracks, cables, etc., and
possible structures and obstacles located in the vicinity either on the ground
or in the air, taking account of the vertical, longitudinal and lateral
movement of the cables and vehicles or of the towing devices under the most
adverse foreseeable operating conditions.
3.1.3. The maximum distance between vehicles and ground
shall, take account of the nature of the cableway installation, the type of
vehicles and the rescue procedures. In the case of open cars it shall also take
account of the risk of fall as well as the psychological aspects associated
with the distance between vehicles and ground.
3.1.4. The maximum speed of the vehicles or towing devices,
the minimum distance between them and their acceleration and braking
performance shall be chosen to ensure the safety of persons and the safe
operation of the cableway installation.
3.2. Stations and structures along the line
3.2.1. Stations and structures along the line shall be
designed, installed and equipped so as to ensure stability. They shall permit
safe guidance of the cables, vehicles and the towing devices, and enable
maintenance to be safely carried out, under all operating conditions.
3.2.2. The entry and exit areas of the cableway installation
shall be designed so as to guarantee the safety of the traffic of vehicles,
towing devices and persons. The movement of vehicles and towing devices in the
stations shall be capable of taking place without risk to persons, taking into
account their possible active collaboration to their movement.
4. Requirements relating to cables, drives and brakes
and to mechanical and electrical installations
4.1. Cables and their supports
4.1.1. All measures shall be taken in line with the latest
technological developments:
–                        
to avoid cables or their attachments breaking,
–                        
to cover their minimum and maximum stress values,
–                        
to ensure that they are safely mounted on their
supports and prevent derailment,
–                        
to enable them to be monitored.
4.1.2. It is not possible to prevent all risk of cable
derailment, measures shall be taken to ensure that cables can be retrieved and
the cableway installations shut down without risk to persons in the event of
derailment.
4.2. Mechanical installations
4.2.1. Drives
The drive system of a cableway installation shall be of a
suitable performance and capability, adapted to the various operating systems
and modes.
4.2.2. Standby drive
The cableway installation shall have a standby drive with
an energy supply which is independent of that of the main drive system. A
standby drive is not, however, necessary if the safety analysis shows that
people can leave the vehicles and, in particular, towing devices easily,
quickly and safely even if a standby drive is not available.
4.2.3. Braking
4.2.3.1. In an emergency, it shall be possible to shut down
the cableway installation and/or the vehicles at any moment, under the most
unfavourable conditions in terms of authorised load and pulley adhesion during
operation. The stopping distance shall be as short as the security of the
cableway installation dictates.
4.2.3.2. Deceleration values shall be within adequate
limits fixed in such a way to ensure both the safety of the persons and the
satisfactory behaviour of the vehicles, cables and other parts of the cableway
installation.
4.2.3.3. In all cableway installations there shall be two
or more braking systems, each capable of bringing the cableway installation to
a halt, and coordinated in such a way that they automatically replace the
active system when its efficiency becomes inadequate. The traction cable's last
braking system shall act directly on the driving pulley. These provisions do
not apply to drag lifts.
4.2.3.4. The cableway installation shall be fitted with an
effective clamp and locking mechanism to guard against premature restarts.
4.3. Control devices
The control devices shall be designed and constructed so as
to be safe and reliable, to withstand normal operating stresses and external
factors such as humidity, extreme temperatures or electromagnetic interference
and so as not to cause dangerous situations, even in the event of operational
error.
4.4. Communication devices
Suitable facilities shall be provided to enable operational
staff to communicate with one another at all times and to inform users in case
of emergency.
5. Vehicles and towing devices
5.1. Vehicles and/or towing devices shall be designed and
fitted out in such a way that under foreseeable operating conditions no person
can fall out or encounter any other risks.
5.2. The fittings of vehicles and towing devices shall be dimensioned
and constructed so as not to:
–                        
 damage the cable, or
–                        
slip, except where slippage does not significantly
affect the safety of the vehicle, the towing device or the installation
under the most unfavourable conditions.
5.3. Vehicle doors (on cars, cabins) shall be designed and
constructed in such a way as to make it possible to close and lock them. The
vehicle floor and walls shall be designed and constructed so as to withstand
pressure and loads exerted by users under any circumstances.
5.4. If for reasons of operational safety an operator is
required on board the vehicle, the vehicle shall be fitted with the equipment
required for him to carry out his tasks.
5.5. Vehicles and/or towing devices and, in particular,
their suspension mechanisms shall be designed and fitted so as to ensure the
safety of workers servicing them in accordance with appropriate rules and
instructions.
5.6. In the case of vehicles equipped with disconnectable
fittings, all measures shall be taken to bring to a halt, without risk to
users, at the moment of departure, any vehicle whose fitting has been
incorrectly connected to the cable and, at the moment of arrival, any vehicle
whose fitting has not been disconnected, and to prevent the vehicle from
falling.
5.7. Funicular vehicles and, in so far as the configuration
of the cableway installation so permits, bi-cable cable cars shall be equipped
with an automatic braking device on the track, when the possibility of carrier
cable breaking cannot reasonably be excluded.
5.8. Where all risk of derailment of the vehicle cannot be
eliminated by other measures, the vehicle shall be fitted with an
anti-derailment device which enables the vehicle to be brought to a halt
without risk to persons.
6. Equipment for users
The access to embarkation areas and exit from
disembarkation areas and the embarkation and disembarkation of users shall be
organised with regard to the movement and stopping of vehicles in such a way as
to ensure the safety of persons, in particular in areas where there is a risk
of falling.
It must be possible for children and persons with reduced
mobility to use the cableway installation safely if the cableway installation
is designed for the transport of such persons.
7. Operability
7.1. Safety
7.1.1. All technical provisions and measures shall be taken
to ensure that the cableway installation is used for its intended purpose according
to its technical specification and to the specified operating conditions and
that the instructions on safe operation and maintenance can be complied with.
The instruction manual and the corresponding notes shall be drawn up in a
language which can be easily understood by users, as determined by the Member State in the territory of which the cableway installation is constructed.
7.1.2. The persons responsible for operating the cableway
installation shall be provided with the appropriate material resources and
shall be qualified to carry out the task in hand.
7.2. Safety in the event of immobilisation of the cableway
installation
All technical provisions and measures shall be adopted to
ensure that users can be brought to safety within a set time appropriate to the
type of cableway installation and its surroundings when the cableway
installation is immobilised and cannot be restarted quickly.
7.3. Other special provisions concerning safety
7.3.1. Operators' stands and workplaces
Movable parts which are normally accessible in the stations
shall be designed, constructed and installed in such a way as to preclude any
risks or, where such risks exist, be fitted with protective devices so as to
prevent any contact with parts of the cableway installation which may cause
accidents. These devices shall be of a type that cannot easily be removed or
rendered inoperative.
7.3.2. Risk of falling
Workplaces and working areas, including those used only
occasionally, and the access to them, shall be designed and constructed in such
a way as to prevent persons required to work or move in them from falling.
Should the construction not be adequate, they shall also be provided with
anchorage points for personal protective equipment to prevent falls.
ANNEX III
SAFETY
ANALYSIS
The safety analysis required according to Article 8 for
every cableway installation shall take into account every mode of operation
envisaged. The analysis shall follow a recognised or established method and
take into account the current state of the art and the complexity of the
cableway installation in question. The aim is also to ensure that the design
and configuration of the cableway installation should take account of the local
surroundings and the most adverse situations in order to ensure satisfactory
safety conditions.
The safety analysis shall also cover the safety devices and
their effect on the cableway installation and related subsystems that they
bring into action so that either:
–                        
they are capable of reacting to an initial
breakdown or failure detected so as to remain either in a state that guarantees
safety, in a lower operating mode or in a fail-safe state,
–                        
they are redundant and are monitored, or
–                        
they are such that the probability of their failure
can be evaluated and they are of a standard equivalent to that achieved by
safety devices that meet the criteria in the first and second indents.
Safety analysis must be used to draw up the inventory of
risks and dangerous situations in accordance with Article 8(1) and to determine
the list of safety components referred to in Article 8(2) thereof. The result
of the safety analysis shall be summarised in a safety report.
ANNEX IV
CONFORMITY
ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE B: EU-TYPE
EXAMINATION – PRODUCTION TYPE
1. EU type-examination is the part of a
conformity assessment procedure in which a notifiedbody examines the technical
design of a subsystem or a safety component and verifies and attests that it
meets the requirements of this Regulation.
2. EU-type examination is carried out by
assessment of the adequacy of the technical design of the subsystem or the
safety component through examination of the technical documentation and
supporting evidence referred to in point 3, plus examination of a specimen,
representative of the production envisaged, of the complete subsystem or safety
component (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 all the
following:
(a)         
the name and address of the manufacturer and, if
the application is lodged by the authorised representative, his name and
address as well,
(b)         
written declaration that the same application
has not been lodged with any other notified body,
(c)         
the technical documentation for the subsystem and/or
the safety component according to Annex IX.
(d)        
a representative specimen of the subsystem or
the safety component envisaged or details of the premises where it can be
examined. The notified body may request further specimens if needed for
carrying out the test program;
4. The notified
body shall:
4.1. examine
the technical documentation and supporting evidence to assess the
adequacy of the technical design of the subsystem or the safety component;
4.2. verify
that the specimen(s) have been manufactured in conformity with the technical
documentation, and identify the elements that have been designed in accordance
with the applicable provisions of the relevant harmonised standards and
technical specifications, as well as the elements which have been designed
without applying the relevant provisions of those standards;
4.3. where the
manufacturer has applied the specifications of the relevant harmonised
standards, carry out the appropriate examinations and tests, or have them
carried out, to check whether these have been applied correctly;
4.4. 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;
4.5. 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 requirements of this Regulation;
4.6. 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 1.4 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 Regulation, 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, any conditions for its validity, the necessary data for
identification of the approved type (subsystem or safety component) and if
relevant, descriptions of its functioning. 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
subsystems and safety components with the examined type to be evaluated and to
allow for in-service control.
The certificate shall have a maximum
validity period of thirty years from the date of its issue. Where the type does not satisfy the applicable requirements of this
Regulation, 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 Regulation 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 any modifications to the approved type that may affect the
conformity of the subsystem or the safety component with the essential
requirements of this Regulation or the conditions for validity of the
certificate.
The notified
body shall examine the modification and inform the manufacturer whether the EU
type-examination certificate remains valid or whether further examinations,
verifications or tests are needed. As appropriate, the notified body shall
issue an addition to the original EU type-examination certificate or ask for a
new application for an EU type-examination to be submitted.
8. Each notified
body shall inform its notifying authorities and the other notified bodies
concerning the EU-type examination certificates and/or any additions thereto
which it has issued.
The notified body which refuses to issue or
withdraws, suspends or otherwise restricts an EU-type examination certificate
must inform its notifying authorities and the other notified bodies
accordingly, giving the reasons for its decision.
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 30 years after the subsystem or the safety
component has been placed on the market.
10. The manufacturer's
obligations set out in points 7 and 9, may be fulfilled by his authorised
representative, provided that they are specified in the mandate.
ANNEX V
CONFORMITY
ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE D:
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 a the manufacturer fulfils the
obligations laid down in points 2.2 and 2.5, and ensures and declares on his
sole responsibility that the subsystems or safety components concerned are in
conformity with the type described in the EU-type examination certificate and
satisfy the requirements of this Regulation that apply to them.
2.
Manufacturing
The
manufacturer shall operate an approved quality system for production, final
product inspection and testing of the subsystems or safety components concerned
as specified in point 2.3, and shall be subject to surveillance as specified in
point 2.4.
3. Quality
system
3.1. The
manufacturer shall lodge an application for assessment of his quality system with
the notified body of his choice.
The application
shall include:
(a)                   
the name and address of the manufacturer and, if
the application is lodged by the authorised representative, his name and
address as well;
(b)                   
a written declaration that the same application
has not been lodged with any other notified body;
(c)                   
all relevant information for the subsystems or
safety components approved under module B;
(d)                  
the documentation concerning the quality system;
(e)                   
the technical documentation of the approved type
and a copy of the EU-type examination certificate(s);
(f)                    
details of the premises where the subsystem or
the safety component is manufactured.
3.2. The quality
system shall ensure that the subsystems or safety components are in conformity
with the type(s) described in the EU-type examination certificate(s) and comply
with the requirements of this Regulation 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:
(a)                   
the quality objectives and the organisational
structure, responsibilities and powers of the management with regard to the
product quality,
(b)                   
the corresponding manufacturing, quality control
and quality assurance techniques, processes and systematic actions that will be
used,
(c)                   
the examinations and tests that will be carried
out before, during and after manufacture, and the frequency with which they
will be carried out,
(d)                  
the quality records, such as inspection reports
and test data, calibration data, qualification reports on the personnel
concerned, etc.,
(e)                   
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.
The audit shall
include an assessment visit to the premises where the subsystems or the safety
components are manufactured, inspected and tested.
In addition to
experience in quality management systems, the auditing team shall have at least
one member with experience of evaluation in the field of cableway installations
and in the technology of the subsystems or safety components concerned,
and knowledge of the applicable requirements of this Regulation. 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(e), to
verify the manufacturer's ability to identify the relevant requirements of this
Regulation and to carry out the necessary examinations with a view to ensuring
compliance of the subsystems or safety components 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 the outcome of the evaluation. In case of a reassessment,
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 production 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:
(a)                   
the quality system documentation;
(b)                   
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 of at least once every two years
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. CE marking
and EU declaration of conformity
5.1. The
manufacturer shall affix the CE marking and, under the responsibility of the
notified body referred to in point 3.1, the latter's identification number to
each individual subsystem or safety component that is in conformity with the
type described in the EU-type examination certificate and satisfies the
applicable requirements of this Regulation. If the notified body agrees and
under its responsibility, the manufacturer may affix the notified body's
identification number to the subsystems or safety components during the
manufacturing process.
5.2. The
manufacturer shall draw up a written EU declaration of conformity for each
subsystem or safety component and keep it at the disposal of the national
authorities for 30 years after the subsystem or the safety component has been
placed on the market. The EU declaration of conformity shall identify the
subsystem or safety component model for which it has been drawn up.
A
copy of the EU declaration of conformity shall be made available to the
relevant authorities upon request.
6. The
manufacturer shall, for a period of 30 years after the last subsystem or safety
component has been placed on the market, keep at the disposal of the national
authorities:
(a)                   
the documentation referred to in point 3.1;
(b)                   
the change referred to in point 3.5, as
approved;
(c)                   
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 withdrawn, and shall, periodically or upon request, make available to
its notifying authorities information related to quality system assessments. 
Each notified body shall inform the other
notified bodies of quality system approvals which it has refused, suspended,
withdrawn or otherwise restricted, giving the reasons for its decision.
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.
ANNEX VI
CONFORMITY
ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE F:
CONFORMITY TO TYPE BASED ON SUBSYSTEM OR SAFETY COMPONENT VERIFICATION
1. Conformity
to type based on subsystem or safety component verification is the part of a
conformity assessment procedure whereby the manufacturer fulfils the
obligations laid down in points 3.2, 3.5.1 and 3.6, and ensures and declares on
his sole responsibility that the subsystems or safety components concerned,
which have been subject to the provisions of point 3.3, are in conformity with
the type described in the EU-type examination certificate and satisfy the
requirements of this Regulation.
2.
Manufacturing
The
manufacturer shall take all measures necessary so that the manufacturing
process and its monitoring ensure conformity of the manufactured subsystems or
safety components with the approved type described in the EU-type examination
certificate and with the requirements of this Regulation.
3. Verification
3.1. The
manufacturer shall lodge an application for subsystem or safety component
verification with the notified body of his choice.
The application
shall include:
(a)                   
the name and address of the manufacturer and, if
the application is lodged by the authorised representative, his name and
address as well;
(b)                   
a written declaration that the same application
has not been lodged with any other notified body;
(c)                   
all relevant information for the subsystems or
safety components approved under module B;
(d)                  
the technical documentation of the approved type
and a copy of the EU-type examination certificate(s);
(e)                   
details of the premises where the subsystem or
the safety component (is manufactured) can be examined.
3.2       The
notified body shall carry out appropriate examinations and tests, or have them carried out, in order to check the
conformity of the subsystems or safety components with the approved type
described in the EU-type examination certificate and with the appropriate
requirements of this Regulation.
The
examinations and tests to check the conformity of the subsystems or safety
components with the appropriate requirements shall be carried out, at the
choice of the manufacturer, either by examination and testing of every
subsystem or safety component as specified in point 4 or by examination and
testing of the subsystems or safety components on a statistical basis as
specified in point 5.
4. Verification
of conformity by examination and testing of every subsystem or safety component
4.1. All
subsystems or safety components shall be individually examined and appropriate
tests set out in the relevant harmonised standard(s), 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 Regulation.
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 subsystem or safety component or have it affixed under its
responsibility.
The manufacturer
shall keep the certificates of conformity available for inspection by the
national authorities for 30 years after the subsystem or safety component has
been placed on the market.
5. Statistical
verification of conformity 
5.1. The
manufacturer shall take all measures necessary so that the manufacturing
process and its monitoring ensure the homogeneity of each lot produced, and
shall present his subsystem or safety component for verification in the form of
homogeneous lots.
5.2. A random
sample shall be taken from each lot according to the requirements of this Regulation. All the subsystems or safety
components in the sample 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 ensure their conformity
with the approved type described in the EU-type examination certificate and
with the applicable requirements of this Regulation in order to determine
whether the lot is accepted or rejected. In the absence of such a harmonised
standard, the notified body concerned shall decide on the appropriate tests to
be carried out.
5.3. If a lot
is accepted, all the subsystems or safety components of the lot shall be
considered approved, except for those subsystems or safety components from the
sample that have been found not to satisfy the tests.
The notified
body shall issue a certificate of conformity in respect to the examinations and
tests carried out, and shall affix its identification number to each approved
subsystem or safety component or have it affixed under its responsibility.
The
manufacturer shall keep the certificates of conformity at the disposal of the
national authorities for 30 years after the subsystem or the safety component
has been placed on the market.
5.4. If a lot
is rejected, the notified body or the competent authority shall take
appropriate measures to prevent that lot being placed on the market. In the
event of the frequent rejection of lots, the notified body may suspend the
statistical verification and take appropriate measures.
6. CE marking
and EU declaration of conformity
6.1. The manufacturer
shall affix the CE marking and, under the responsibility of the notified body
referred to in point 3, the latter's identification number to each individual
subsystem or safety component that is in conformity with the approved type
described in the EU-type examination certificate and satisfies the applicable
requirements of this Regulation. 
6.2. The
manufacturer shall draw up a written EU declaration of conformity for each
subsystem or safety component and keep it at the disposal of the national authorities,
for 30 years after the subsystem or the safety component has been placed on the
market. The EU declaration of conformity shall identify the subsystem or safety
component for which it has been drawn up.
A copy of the
EU declaration of conformity shall be made available to the relevant
authorities upon request.
A copy of the EU declaration of conformity shall be made
available 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
subsystems or safety components.
7. If the
notified body agrees and under its responsibility, the manufacturer may affix
the notified body's identification number to the subsystems or safety
components during the manufacturing process.
8. Authorised
representative
The
manufacturer's obligations set out in points 2 and 5.1 may be fulfilled by his
authorised representative, on his behalf and under his responsibility, provided
that they are specified in the mandate.
ANNEX VII
CONFORMITY
ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE G:
CONFORMITY BASED ON UNIT VERIFICATION
1. Conformity based on unit verification is
the conformity assessment procedure whereby a the manufacturer fulfils
the obligations laid down in points 4.2, 4.3 and 4.5, and ensures and declares
on his sole responsibility that the subsystem or safety component concerned,
which has been subject to the provisions of point 4.4, is in conformity with
the requirements of this Regulation.
2. Manufacturing
The manufacturer shall take all measures
necessary so that the design and manufacturing process and its monitoring
ensure conformity of the manufactured subsystem or safety component with the
applicable requirements of this Regulation.
3. Verification
3.1. The
manufacturer shall lodge an application for unit verification of a subsystem or
a safety component with the notified body of his choice.
The application
shall include:
(a)                   
the name and address of the manufacturer and, if
the application is lodged by the authorised representative, his name and
address as well;
(b)                   
a written declaration that the same application
has not been lodged with any other notified body;
(c)                   
the technical documentation for the subsystem or
the safety component according to Annex IX;
(d)                  
details of the premises where the subsystem or
the safety component (is manufactured) can be examined.
3.2       The notified body shall examine
the technical documentation for the subsystem or the safety component and shall
carry out the appropriate examinations and tests, as set out in the relevant
harmonised standards and/or technical specifications, or equivalent tests, to
ensure its conformity with the applicable requirements of this Regulation, 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 subsystem or the safety
component, or have it affixed under its responsibility.
If the notified body refuses to issue a
certificate of conformity, it shall state in detail the reasons for the refusal
and indicate the necessary corrective measures to be taken.
When the manufacturer reapplies for unit
verification of the subsystem or the safety component concerned, he shall apply
to the same notified body.
On request, the notified body shall provide
the Commission and the member States with a copy of the certificate of
conformity.
The manufacturer shall keep the technical
documentation and a copy of the certificate of conformity at the disposal of
the national authorities for 30 years after the subsystem or the safety
component has been placed on the market.
4. CE marking and EU declaration of
conformity
4.1. The manufacturer shall affix the CE
marking and, under the responsibility of the notified body referred to in point
4, the latter's identification number to each subsystem or safety component
that satisfies the applicable requirements of this Regulation.
4.2. The manufacturer shall draw up a
written EU declaration of conformity and keep it at the disposal of the
national authorities for 30 years after the subsystem or the safety component
has been placed on the market. The EU declaration of conformity shall identify
the subsystem or the safety component for which it has been drawn up.
A copy of the EU declaration of conformity
shall be made available to the relevant authorities upon request.
5. Authorised representative
The manufacturer's obligations set out in
points 3.1 and 4 may be fulfilled by his authorised representative, on his
behalf and under his responsibility, provided that they are specified in the
mandate.
ANNEX VIII
CONFORMITY
ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE H:
CONFORMITY BASED ON FULL QUALITY ASSURANCE
1.         Conformity based on full quality
assurance is the 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 subsystems or safety components concerned
satisfy the requirements of this Regulation.
2. Manufacturing
The manufacturer shall operate an approved
quality system for the design, manufacture and final inspection and testing of subsystems
or safety components 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 subsystems or safety components concerned.
The application shall include:
(a)                   
the name and address of the manufacturer and, if
the application is lodged by the authorised representative, his name and
address as well;
(b)                   
all necessary information on the subsystems or
safety components to be manufactured;
(c)                   
the technical documentation in accordance to
Annex IX for one representative type of each category of subsystem or safety
component to be manufactured.
(d)                  
the documentation concerning the quality system;
(e)                   
details of the premises where the subsystems or
safety components are designed, manufactured, inspected and tested; 
(f)                    
a written declaration that the same application
has not been lodged with any other notified body.
3.2. The quality system shall ensure
compliance of the subsystem or the safety component with the requirements of
this Regulation that apply to it.
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:
(a)                   
the quality objectives and the organisational
structure, responsibilities and powers of the management with regard to the
design and quality of the subsystems and the safety components;
(b)                   
the technical design specifications, including
standards, that will be applied and, where the relevant harmonised standards will
not be applied in full, the means that will be used to ensure that the
essential requirements of this Regulation will be met;
(c)                   
the design control and design verification
techniques, processes and systematic actions that will be used when designing
the subsystems or the safety components.
(d)                  
the corresponding manufacturing, quality control
and quality assurance techniques, processes and systematic actions that will be
used;
(e)                   
the examinations and tests to be carried out
before, during and after manufacture, and the frequency with which they will be
carried out;
(f)                    
the quality records, such as inspection reports
and test data, calibration data, qualification reports on the personnel
concerned, etc.;
(g)                   
the means of monitoring the achievement of the
required design and 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 specification.
The audit shall include an assessment visit
to the premises where the subsystems or the safety components are designed,
manufactured, inspected and tested.
In addition to experience in quality
management systems, the auditing team shall have at least one member
experienced as assessor in the field of cableway installations and in the
technology of the subsystems or safety components concerned, and knowledge of
the applicable requirements of this Regulation. 
The auditing team shall review the
technical documentation referred to in point 3.1 to verify the manufacturer's
ability to identify the applicable requirements of this Regulation and to carry
out the necessary examinations with a view to ensuring compliance of the
subsystems or the safety components with those requirements.
The notified body shall notify its decision
to the manufacturer or his authorised representative. 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 the
outcome of the evaluation. In case of a reassessment, it shall notify the
manufacturer of its decision. The notification shall contain the conclusions of
the assessment 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 design, manufacture,
inspection, testing, and storage sites, and shall provide it with all necessary
information, in particular:
(a)                   
the quality system documentation;
(b)                   
the quality records provided for by the design
part of the quality system, such as results of analyses, calculations, tests,
etc.;
(c)                   
the quality records as provided for by
the manufacturing part of the quality system, 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. The
frequency of periodic audits shall be such that a full reassessment is carried
out every three years.
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 check the proper
functioning of the quality system. It shall provide the manufacturer with a
visit report and, if tests have been carried out, with a test report.
5.         CE marking and EU declaration of
conformity
5.1.      The manufacturer shall affix the
CE marking and, under the responsibility of the notified body referred to in
point 3.1, the latter's identification number to each individual subsystem or
safety component that is in conformity with the type as described in the
EU-type examination certificate and satisfies the applicable requirements of
this Regulation.
If the notified body agrees and under its
responsibility, the manufacturer may affix the notified body's identification
number to the subsystems or safety components during the manufacturing process.
5.2.      The manufacturer shall draw up a
written EU declaration of conformity for each subsystem or safety component and
keep a copy of it at the disposal of the national authorities for 30 years
after the subsystem or the safety component has been placed on the market. The
EU declaration of conformity shall identify the subsystem or the safety
component for which it has been drawn up.
A copy of the EU declaration of conformity
shall be made available to the relevant authorities upon request.
6. The manufacturer shall, for a period of 30
years after the last subsystem or safety component has been placed on the
market, keep at the disposal of the national authorities:
(a)                   
the technical documentation referred to in point
3.1(c);
(b)                   
the documentation concerning the quality system
referred to in point 3.1; 
(c)                   
the documentation relating to the change referred
to in point 3.5 as approved;
(d)                  
the decisions and reports of the notified body
referred to in points 3.3, 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.
ANNEX IX
TECHNICAL
DOCUMENTATION FOR SUBSYSTEMS AND SAFETY COMPONENTS:
(1)                   
The technical documentation shall make it
possible to assess the conformity of the subsystem or the safety component with
the applicable requirements of this Regulation and shall include an adequate
analysis and assessment of the risks. The technical documentation shall specify
the applicable requirements and cover, as far as relevant for the conformity
assessment, the design, manufacture and operation of the subsystem or safety
component. 
(2)                   
The technical documentation shall contain, at
least the following elements:
(a)         
a general description of the subsystem or the safety
component,
(b)         
design and manufacturing drawings and diagrams of
components, subassemblies, circuits etc. and the descriptions and explanations
necessary for the understanding of those drawings and diagrams and of the
operation of the subsystem or safety component,
(c)         
a list of the harmonised standards and/or other
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 requirements of this Regulation
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;
(d)        
the supporting evidence for the adequacy of the
design, including the results of any design calculations, examinations or tests
carried out by or for the manufacturer and the related reports;
(e)         
a copy of the instructions for the subsystem or
the safety component;
(f)          
for subsystems, a copy of the EU Declarations of
conformity for the safety components incorporated into the subsystem.
ANNEX X
EU
DECLARATION OF CONFORMITY FOR SUBSYSTEMS AND SAFETY COMPONENTS
(1)                   
The EU declaration of conformity shall accompany
the subsystem or the safety component. It shall be drawn
up in the same language or languages as the manual referred to in point 7.1.1
of Annex II.
(2)                   
The EU declaration of conformity shall contain
the following elements:
(a)         
Subsystem/safety component model (product,
batch, type or serial number).
(b)         
Name and address of the manufacturer and, where
applicable, his authorised representative.
(c)         
This declaration of conformity is issued under
the sole responsibility of the manufacturer.
(d)        
Object of the declaration (identification of the
subsystem or safety component allowing traceability. It may, where necessary
for the identification of the subsystem or safety component, include an image):
–              
description of the subsystem or safety component
(type, etc.);
–              
conformity assessment procedure followed;
–              
name and address of the notified body which
carried out the conformity assessment;
–              
reference to the EU-type examination certificate
with details, including its date, and where appropriate,
information on the duration and conditions of its validity;
–              
all relevant provisions with which the component
must comply and, in particular, the conditions of use.
(e)         
The object of the declaration described above is
in conformity with the relevant Union harmonisation legislation: …………….
(reference to the other Union Acts applied):
(f)          
References to the relevant harmonised standards
used or references to the specifications in relation to which conformity is
declared:
(g)         
The notified body or bodies … (name, address,
number) … performed … (description of intervention) … and issued the
certificate(s): …
(h)         
- identification of the person empowered to sign
on behalf of the manufacturer or his authorised representative;.
(i)           
Additional information:
Signed for and on behalf of: …………………….
(place and date of issue):
(name, function) (signature):
ANNEX XI
 CORRELATION TABLE 
 Directive 2000/9/EC || This Regulation 
 ___ || Article 1 
 Article 1(1) || Article 2(1) 
 Article 1(2) || Article 3(1) 
 Article 1(3) || Article 3(7) to 3(9) 
 Article 1(4) 1rst and second subparagraphs || ___ 
 Article 1(4) third subparagraph || Article 8(3) 
 Article 1(5) || Article 3(1), (3) to (6) 
 Article 2 || ___ 
 Article 3 || Article 6 
 ___ || Article 3(10) to (27) 
 Article 4 || Article 8 
 Article 5(1) || Article 4(1) and (2) 
 Article 5(2) || Article 3 
 Article 6 || Article 7 
 Article 7 || Article ___ 
 Article 8 || Article 4(1) and (2) 
 Article 9 || Article 4(1) and (2) 
 Article 10 || ___ 
 Article 11(1) || Article 9(1) 
 Article 11(2) || Article 4(2) 
 Article 11(3) || ___ 
 Article 11(4) || ___ 
 Article 11(5) || ___ 
 Article 11(6) || ___ 
 Article 11(7) || ___ 
 ___ || Article 11 
 ___ || Article 12 
 ___ || Article 13 
 ___ || Article 14 
 ___ || Article 15 
 ___ || Article 16 
 Article 12 || Article 9(4) 
 Article 13 || Article 10(1) 
 Article 14 || Article ___ 
 Article 15 || Article 10(2) 
 Article 16 || ___ 
 ___ || Article 17 
 ___ || Article 18 
 ___ || Article 19 
 ___ || Article 20 
 ___ || Article 21 
 ___ || Article 22 
 ___ || Article 23 
 ___ || Article 24 
 ___ || Article 25 
 ___ || Article 26 
 ___ || Article 27 
 ___ || Article 28 
 ___ || Article 29 
 ___ || Article 30 
 ___ || Article 31 
 ___ || Article 32 
 ___ || Article 33 
 ___ || Article 34 
 ___ || Article 35 
 ___ || Article 36 
 ___ || Article 37 
 ___ || Article 38 
 Article 17 || Article 39 
 Article 18 || ___ 
 Article 19 || ___ 
 Article 20 || ___ 
 Article 21 || ___ 
 Article 22 || ___ 
 Article 23 || ___ 
 ___ || Article 40 
 ___ || Article 41 
 ___ || Article 42 
 ___ || Article 43 
 Annex I || Annex I 
 Annex II || Annex II 
 Annex III || Annex III 
 Annex IV || Annex IX 
 Annex V || Annexes IV to VIII 
 Annex VI || Annex IX 
 Annex VII || Annexes IV to VIII 
 Annex VIII || __ 
 Annex IX || __ 
 __ || Annex X