# EUR-Lex - 52011PC0770 - EN

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# 52011PC0770

**Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the harmonisation of the laws of the Member States relating to making available on the market of lifts and safety components for lifts /* COM/2011/0770 final - 2011/0354 (COD) */**

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EXPLANATORY
MEMORANDUM

1.
context of the proposal

General context,
reasons for and objectives of this proposal

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

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

Directive 95/16/EC is
an example of that Union harmonisation legislation, ensuring the free movement
of lifts and safety components for lifts. It sets out essential health and safety
requirements that lifts and safety components for lifts must comply with in
order to be made available on the EU market. Manufacturers must demonstrate
that a lift and a safety component for lifts have been designed and
manufactured in compliance with the essential health and safety requirements
and affix the CE marking.

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

–
the presence of
non-compliant or dangerous products on the market and consequently a certain
lack of trust in CE marking

–
competitive disadvantages
for economic operators complying with the legislation as opposed to those
circumventing the rules

–
unequal treatment in the
case of non-compliant products and distortion of competition amongst economic
operators due to different enforcement practices

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

–
problems with the quality of
certain notified bodies

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

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

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

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

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

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

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

For a number of other
Union harmonisation directives, including Directive 95/16/EC, no revision for
sector-specific problems had been envisaged within this timeframe. To ensure
that the problems in relation to non-compliance and notified bodies are
nevertheless addressed in these sectors, and for the sake of consistency of the
overall regulatory environment on products, it was decided to align these
directives within a package to the provisions of the NLF Decision.

Consistency with
other policies and objectives of the Union

This initiative is in
line with the Single Market Act[1],
which has stressed the need to restore consumer confidence in the quality of
products on the market and the importance of reinforcing market surveillance.

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

2.
consultation of interested parties and
impact assessment

Consultation of
interested parties

The alignment of
Directive 95/16/EC to the NLF Decision has been discussed with national experts
responsible for the implementation of this Directive, the notified body group,
the administrative cooperation group, standardisation bodies, representatives
for the lifts sector as well as in bilateral meetings with associations
representing lift installers, lifts components manufacturers and small and
medium size enterprises in the lifts industry, trade unions and associations of
property owners.

From June to October
2010 a public consultation was organised that comprised all the sectors
involved in this initiative. It consisted of four targeted questionnaires for
economic operators, authorities, notified bodies and users and the Commission
services received 300 replies. The results are published at:

http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/new-legislative-framework/index_en.htm

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

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

Collection and use
of expertise

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

External expertise was
used to obtain some basic data on certain sectors, including studies concerning
lifts: (2004)[2] and (2007)[3].

Impact assessment

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

Option 1 - No
changes to the current situation

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

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

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

Option 3 – Alignment
to NLF Decision by legislative measures

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

Option 3 was found to be the preferred option because

–
it will improve the
competitiveness of companies and notified bodies taking their obligations seriously,
as opposed to those cheating on the system;

–
it will improve the
functioning of the internal market by ensuring equal treatment of all economic
operators, notably importers and distributors, as well as notified bodies;

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

–
it is considered more
effective than option 2: due to the lack of enforceability of option 2 it is
questionable that the positive impacts would materialise under that option;

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

3.
Main elements of the proposal
3.1.
Horizontal definitions

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

3.2.
Obligations of economic
operators and traceability requirements

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

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

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

3.3.
Harmonised standards

Compliance with harmonised standards
provides a presumption of conformity with the essential health and safety requirements.
On 1 June 2011 the Commission adopted a proposal for a Regulation on European
Standardisation[4]
that sets out a horizontal legal framework for European standardisation. The
proposal for the Regulation contains inter alia provisions on standardisation
requests from the Commission to the European Standardisation Organisations, on
the procedure for objections to harmonised standards and on stakeholder
participation in the standardisation process. Consequently the provisions of
Directive 95/16/EC which cover the same aspects have been deleted in this
proposal for reasons of legal certainty.

The provision conferring presumption of
conformity to harmonised standards has been modified to clarify the extent of
the presumption of conformity when standards only partially cover the essential
health and safety requirements.

3.4.
Conformity assessment and CE
marking

Directive 95/16/EC has
selected the appropriate conformity assessment procedures which installers have
to apply in order to demonstrate that lifts they install comply with the
essential health and safety requirements.

The proposal aligns
these procedures to their updated versions set out in the NLF Decision. Sector
specific elements of the procedures have been maintained. It also introduces a
model for the EU Declaration of conformity.

General principles of
the CE marking are set out in Article 30 of Regulation 765/2008, while the
detailed provisions on the affixing of the CE marking to lifts and safety
components for lifts have been inserted in this proposal.

3.5.
Notified Bodies

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

3.6.
Market surveillance and the
safeguard clause procedure

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

3.7.
Comitology and Delegated
acts

The Treaty on the
Functioning of the EU has introduced a clear distinction between delegated acts
(Article 290) and implementing acts (Article 291) and clarified the role of committees.

Directive 95/16/EC
provided for a Standing Committee. As this committee is not involved in the
adoption of implementing acts provided for in Article 291 of the Treaty on the
Functioning of the EU, and no need to adopt implementing acts appears under the
new Directive, this provision has been deleted in the proposal.

The Commission will set
up an expert working group in accordance with the Commission Communication -
Framework for Commission expert groups: horizontal rules and public register[5], that will carry
out the tasks of the Standing Committee provided for in Directive 95/16/EC, to
examine any question relating to the application of the Directive.

The proposal introduces
the power for the Commission to adopt delegated acts in order to adapt the list
of safety components for lifts set out in Annex III to technical progress and
new scientific evidence.

4.
legal elements of the proposal

Legal basis

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

Subsidiarity
principle

The internal market is
a competence that is shared between the Union and the Member States. The
subsidiarity principle arises in particular with regard to the newly added
provisions aiming at the improvement of effective enforcement of Directive
95/16/EC namely, the importer and distributor obligations, the traceability
provisions, the provisions on the assessment and notification of notified
bodies, and the enhanced cooperation obligations in the context of the revised
market surveillance and safeguard procedures.

Experience with the
enforcement of the legislation has shown that measures taken at national level
have led to divergent approaches and to a different treatment of economic
operators inside the EU, which undermines the objective of this directive. If
actions are taken at national level to address the problems, this risks
creating obstacles to the free movement of goods. Furthermore action at
national level is limited to the territorial competence of a Member State. In
view of the increasing internationalisation of trade, the number of
cross-border cases is constantly rising. Coordinated action at EU level can much
better achieve the objectives set, and will in particular render market
surveillance more effective. Hence it is more appropriate to take action at EU
level.

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

Proportionality

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

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

Legislative
technique used

The alignment to the
NLF Decision requires a number of substantive amendments to the provisions of
Directive 95/16/EC. To ensure the readability of the amended text the technique
of recasting has been chosen in line with the Interinstitutional Agreement of
28 November 2001 on a more structured use of the recasting technique for legal
acts[6].

The changes made to the
provisions of Directive 95/16/EC concern: the definitions, the obligations of
economic operators, the presumption of conformity provided by harmonised
standards, the declaration of conformity, CE marking, notified bodies, the
safeguard clause procedure and the conformity assessment procedures.

The proposal does not
change the scope of Directive 95/16/EC and the essential health and safety
requirements.

5.
budgetary implications

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

6.
additional information

Repeal of existing
legislation

The adoption of the
proposal will lead to repeal of Directive 95/16/EC.

European Economic
Area

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

ê 95/16/EC (adapted)

2011/0354 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on the Ö harmonisation Õ approximation
of the laws of the Member States relating to Ömaking
available on the market of Õlifts Ö and
safety components for lifts Õ

(Recast)

(Text with EEA relevance)

THE EUROPEAN
PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the
proposal from the European Commission,

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

Having regard to the
opinion of the European Economic and Social Committee[7],

Acting in accordance
with the ordinary legislative procedure,

Whereas:

ê 95/16/EC recital 1

Whereas
Member States are responsible within their territory for the health and safety
of people;

ê 95/16/EC recital 2 (adapted)

Whereas paragraphs 65 and 68 of the White Paper on
the completion of the internal market, approved by the European Council in
June 1985, provide for a new approach to the approximation of laws;

ê 95/16/EC recital 3 (adapted)

Whereas Council Directive 84/529/EEC of 17
September 1984 on the approximation of the laws of the Member States
relating to electrically, hydraulically or oil-electrically operated lifts[8] does not ensure freedom of movement for all types of lift; whereas
disparities between the binding provisions of the various national systems for
types of lift not covered by Directive 84/529/EEC constitute barriers to
trade within the Community; whereas the national rules on lifts should
therefore be harmonized;

ê 95/16/EC recital 4 (adapted)

Whereas Council Directive 84/528/EEC of 17
September 1984 on the approximation of the laws of the Member States
relating to common provisions for lifting and mechanical handling appliances[9] serves as a framework Directive for two specific Directives, namely
Directive 84/529/EEC and Council Directive 86/663/EEC of 22 December 1986 on
the approximation of the laws of the Member States relating to self-propelled
industrial trucks[10], repealed by Council Directive 91/368/EEC of 20 June 1991 amending
Directive 89/392/EEC on the approximation of the laws of the Member States
relating to machinery[11];

ò new

(1)
Directive
95/16/EC of the European Parliament and the Council of 29 June 1995 on the
approximation of the laws of the Member States relating to lifts[12] has been
substantially amended several times. Since further amendments are to be made,
it should be recast in the interests of clarity.

(2)
Regulation
(EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008
setting out the requirements for accreditation and market surveillance relating
to the marketing of products and repealing Regulation (EEC) No 339/93[13] lays down rules on
the accreditation of conformity assessment bodies, provides a framework for the
market surveillance of products and for controls on products from third
countries, and lays down the general principles of the CE marking. In order to
ensure legal certainty, it is necessary to clarify that rules on Union market
surveillance and control of lifts and safety components for lifts entering the
Union market provided for in Regulation (EC) No 765/2008 apply to lifts and
safety components for lifts covered by this Directive. This Directive should
not prevent Member States from choosing the competent authorities to carry out
those tasks.

(3)
Decision
No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on
a common framework for the marketing of products, and repealing Council
Decision 93/465/EEC[14]
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 95/16/EC should therefore be adapted to
that Decision.

ê 95/16/EC recital 5 (adapted)

(4)
Whereas oOn 8 June 1995 the Commission adopted recommendation
No 95/216/EC[15]
to the Member States concerning improvement of safety of existing lifts;.

ê 95/16/EC recital 6 (adapted)

Whereas the essential requirements of this Directive will guarantee the intended
level of safety only if appropriate conformity assessment procedures, chosen
from among the provisions of Council Decision 93/465/EEC of 22 July 1993
concerning the modules for the various phases of the conformity assessment
procedures and the rules for the affixing
and use of the CE conformity marking, which are intended to be used in the
technical harmonization directives[16] ensure compliance therewith.

ê 95/16/EC recital 7 (adapted)

Whereas the CE marking must be visibly affixed to
lifts or to certain safety components of lifts which meet the essential
health and safety requirements of this Directive to enable them to be placed on
the market;

ê 95/16/EC recital 8 (adapted)

Whereas this Directive defines only general
essential health and safety requirements; whereas, in order to help
manufacturers prove conformity with these essential requirements, it is
desirable to have standards harmonized at European level concerning the
prevention of risks arising from the design and installation of lifts, and also in order to enable conformity
with the essential requirements to be verified; whereas such standards are
drawn up at European level by private-law bodies and must retain their
non-binding status; whereas, for this purpose, the European Committee for
Standardization (CEN) and the European Committee for Electrotechnical
Standardization (Cenelec) are recognized as the competent bodies for adopting
harmonized standards in accordance with the general guidelines for cooperation
between the Commission and CEN and Cenelec
signed on 13 November 1984; whereas a harmonized standard within the meaning of
this Directive is a technical specification adopted by CEN and/or Cenelec on
the basis of a mandate from the Commission in accordance with Council Directive
83/189/EEC of 28 March 1983 laying down a procedure for the provision of
information in the field of technical standards and regulations[17] and pursuant to the abovementioned general guidelines;

ê 95/16/EC recital 10 (adapted)

Whereas this Directive is designed to cover all
risks caused by lifts and run by their users and by the occupants of the
construction; whereas this Directive should therefore be regarded as a
Directive within the meaning of Article 2(3) of Council Directive 89/106/EEC of 21 December 1988 on the approximation of
laws, regulations and administrative provisions of the Member States relating
to construction products[18];

ê 95/16/EC recital 11(adapted)

Whereas
an agreement on a modus vivendi between the European Parliament, the Council and the Commission
concerning the implementing measures for acts adopted in accordance with the
procedure laid down in Article 189b of the EC Treaty was reached on 20 December
1994,

ò new

(5)
Economic
operators should be responsible for the compliance of lifts and safety
components for lifts, in relation to their respective roles in the supply
chain, so as to ensure a high level of protection of public interests, such as
health and safety, and the protection of consumers and to guarantee fair
competition on the Union market.

(6)
All
economic operators intervening in the supply and distribution chain should take
appropriate measures to ensure that they only make available on the market
lifts and safety components for lifts which are in conformity with this
Directive. It is necessary to provide for a clear and proportionate
distribution of obligations which correspond to the role of each operator in
the supply and distribution process.

(7)
The
manufacturer and installer, having the detailed knowledge of the design and
production process, are best placed to carry out the complete conformity
assessment procedure. Conformity assessment should therefore remain the
obligation of the installer or manufacturer alone.

(8)
It is
necessary to ensure that safety components for lifts from third countries
entering the Union market comply with the requirements of this Directive, and
in particular that the appropriate assessment procedures have been carried out
by the manufacturer with regard to those safety components for lifts. Provision
should therefore be made for importers to make sure that the safety components
for lifts they place on the market comply with the requirements of this
Directive and that they do not place on the market safety components for lifts
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 safety component for lifts marking and
documentation drawn up by manufacturers are available for inspection by the
supervisory authorities.

(9)
The
distributor makes a safety component for lifts 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 safety component for lifts
does not adversely affect the compliance of the safety component for lifts.

(10)
When
placing a safety component for lifts on the market, every importer should
indicate on the safety component for lifts his name and the address at which he
can be contacted. Exceptions should be provided for in cases where the size or
nature of the safety component for lifts 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 for lifts.

(11)
Any
economic operator that either places a lift or safety component for lifts on
the market under his own name or trademark or modifies a lift or safety
component for lifts in such a way that compliance with the requirements of this
Directive may be affected should be considered to be the installer or
manufacturer and should assume the obligations of the installer or manufacturer.

(12)
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 safety components for lifts concerned.

(13)
Ensuring
traceability of lifts or safety components for lifts 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 lifts or safety components
for lifts available on the market.

(14)
This
Directive should be limited to the expression of the essential health and
safety requirements. In order to facilitate conformity assessment for lifts and
safety components for lifts with those requirements it is necessary to provide
for presumption of conformity for lifts and safety components for lifts which
are in conformity with harmonised standards that are adopted in accordance with
Regulation (EU) No [../..] of the European Parliament and of the Council of
[...] on European Standardisation and amending Council Directives 89/686/EEC
and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/105/EC and 2009/23/EC of the European Parliament
and of the Council[19] for the purpose of expressing detailed
technical specifications of those requirements. The essential health and safety
requirements of this Directive will guarantee the intended level of safety only
if appropriate conformity assessment procedures ensure compliance therewith.

(15)
Regulation
(EU) No [../..] [on European Standardisation] provides for a procedure for
objections to harmonised standards where those standards do not entirely
satisfy requirements of this Directive.

(16)
In order
to enable economic operators to demonstrate and the competent authorities to
ensure that lifts or safety components for lifts made available on the market
conform to the essential health and safety requirements it is necessary to
provide for conformity assessment procedures. Decision No 768/2008/EC
establishes modules for conformity assessment procedures, which include
procedures from the least to the most stringent, in proportion to the level of
risk involved and the level of safety required. In order to ensure
inter-sectoral coherence and to avoid ad-hoc variants, conformity assessment
procedures should be chosen from among those modules.

(17)
The installer
or the manufacturer should draw up an EU declaration of conformity to provide
detailed information on the conformity of a lift or safety components for lifts
with the requirements of the relevant Union harmonisation legislation.

(18)
The CE
marking, indicating the conformity of a lift or safety components for lifts, is
the visible consequence of a whole process comprising conformity assessment in
a broad sense. General principles governing the CE marking are set out in
Regulation (EC) No 765/2008. Rules governing the affixing of the CE marking
should be laid down in this Directive.

(19)
The
conformity assessment procedures set out in this Directive require the
intervention of conformity assessment bodies, which are notified by the Member
States to the Commission.

(20)
Experience
has shown that the criteria set out in Directive 95/16/EC that conformity
assessment bodies have to fulfil to be notified to the Commission are not
sufficient to ensure a uniformly high level of performance of notified bodies
throughout the Union. It is, however, essential that all notified bodies
perform their functions to the same level and under conditions of fair
competition. That requires the setting of obligatory requirements for
conformity assessment bodies wishing to be notified in order to provide
conformity assessment services.

(21)
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.

(22)
If a
conformity assessment body demonstrates conformity with the criteria laid down
in harmonised standards, it should be presumed to comply with the corresponding
requirements set out in this Directive.

(23)
The system
set out in this Directive should be complemented by the accreditation system
provided for in Regulation (EC) No 765/2008. Since accreditation is an
essential means of verifying the competence of conformity assessment bodies, it
should also be used for the purposes of notification.

(24)
Transparent
accreditation as provided for in Regulation (EC) No 765/2008, ensuring the
necessary level of confidence in conformity certificates, should be considered
by the national public authorities throughout the Union as the preferred means
of demonstrating the technical competence of conformity assessment bodies. However,
national authorities may consider that they possess the appropriate means of
carrying out this evaluation themselves. In such cases, in order to ensure the
appropriate level of credibility of evaluations carried out by other national
authorities, they should provide the Commission and the other Member States
with the necessary documentary evidence demonstrating the compliance of the
conformity assessment bodies evaluated with the relevant regulatory
requirements.

(25)
Conformity
assessment bodies frequently subcontract parts of their activities linked to
the assessment of conformity or have recourse to a subsidiary. In order to
safeguard the level of protection required for the products to be placed on the
Union market, it is essential that conformity assessment subcontractors and
subsidiaries fulfil the same requirements as notified bodies in relation to the
performance of conformity assessment tasks. Therefore, it is important that the
assessment of the competence and the performance of bodies to be notified and
the monitoring of bodies already notified cover also activities carried out by
subcontractors and subsidiaries.

(26)
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.

(27)
Since
notified bodies may offer their services throughout the Union, it is
appropriate to give the other Member States and the Commission the opportunity
to raise objections concerning a notified body. It is therefore important to
provide for a period during which any doubts or concerns as to the competence
of conformity assessment bodies can be clarified before they start operating as
notified bodies.

(28)
In the
interests of competitiveness, it is crucial that notified bodies apply the
conformity assessment procedures without creating unnecessary burdens for
economic operators. For the same reason, and to ensure equal treatment of
economic operators, consistency in the technical application of the conformity
assessment procedures needs to be ensured. That can best be achieved through
appropriate coordination and cooperation between notified bodies.

(29)
Directive
95/16/EC already provides for a safeguard procedure which applies only in the
event of disagreement between Member States over measures taken by a Member
State. In order to increase transparency and to reduce processing time, it is
necessary to improve the existing safeguard clause procedure, with a view to
making it more efficient and drawing on the expertise available in Member
States.

(30)
The
existing system should be supplemented by a procedure under which interested
parties are informed of measures intended to be taken with regard to lifts or
safety components for lifts presenting a risk to the health and safety of persons
or to other aspects of public interest protection. It should also allow market
surveillance authorities, in cooperation with the relevant economic operators,
to act at an earlier stage in respect of such lifts and safety components for
lifts.

(31)
Where the
Member States and the Commission agree as to the justification of a measure
taken by a Member State, no further involvement of the Commission should be
required, except where non-compliance can be attributed to shortcomings of a
harmonised standard.

(32)
In order
to keep the list of safety components for lifts up to date, the power to adopt
acts in accordance with Article 290 of the Treaty on the Functioning of the
European Union should be delegated to the Commission in respect of adaptations
of Annex III to this Directive to technical progress and new scientific
evidence. It is of particular importance that the Commission carry out
appropriate consultations during its preparatory work, including at expert
level.

(33)
The
Commission, when preparing and drawing-up delegated acts, should ensure a
simultaneous, timely and appropriate transmission of relevant documents to the
European Parliament and Council.

(34)
In order to monitor
and ensure the efficiency in the application of this Directive, Member States should
be required to send a report on the application of the Directive to the
Commission. The Commission should then draw up and publish a summary of the
reports.

(35)
The Member
States should lay down rules on penalties applicable to infringements of the
national provisions adopted pursuant to this Directive and ensure that they are
implemented. Those penalties should be effective, proportionate and dissuasive.

(36)
Since the objective of
this Directive, namely to ensure that lifts and safety components for lifts on
the market fulfil the requirements providing a high level of protection of
health and safety and other public interests while guaranteeing the functioning
of the internal market, cannot be sufficiently achieved by the Member States
and can therefore, by reason of its scale and effects, be better achieved at
Union level, the Union may adopt measures, in accordance with the principle of
subsidiarity as set out in Article 5 of the Treaty on European Union. In
accordance with the principle of proportionality, as set out in that Article,
this Directive does not go beyond what is necessary in order to achieve that
objective.

ê 95/16/EC
recital 9 (adapted)

ð new

(37)
Whereas provisions
should be made Ö It is
necessary to provide Õ for
transitional arrangements to enable
installers to place on the market lifts manufactured before the date of
implementation of this Directive; ð that allow making available on the
market and putting into service of lifts that have already been placed on the
market in accordance with Directive 95/16/EC. ï

ò new

(38)
It is necessary to
provide for transitional arrangements that allow making available on the market
of safety components for lifts that have already been placed on the market in
accordance with Directive 95/16/EC.

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

(40)
This
Directive should be without prejudice to the obligations of the Member States
relating to the time-limits for transposition into national law and application
of the Directives set out in Annex XIII, Part B.

ê 95/16/EC (adapted)

HAVE ADOPTED
THIS DIRECTIVE:

CHAPTER I

Scope, placing on the market and free movement

Ö GENERAL PROVISIONS Õ

Article 1
Ö Scope Õ

1.
This Directive shall apply to lifts permanently serving buildings and constructions
It shall also apply
to the safety components for use in such lifts listed in Annex IV .

ê 2006/42/EC
Art. 24.1 (adapted)

2. For the purposes of this Directive, ‘lift’
shall mean a lifting appliance serving specific levels, having a carrier moving
along guides which are rigid and inclined at an angle of more than 15 degrees
to the horizontal, and intended
for the transport of:

ê 2006/42/EC
Art. 24.1

(a)        - persons,;

(b)        - persons and goods,;

(c)        - goods alone if the carrier is accessible, that is to say a person
may enter it without difficulty, and fitted with controls situated inside the
carrier or within reach of a person inside the carrier.

ê 95/16/EC
(adapted)

Ö This
Directive shall also apply to the safety components for lifts for use in such
lifts listed in Annex III. Õ

ê 2006/42/EC
Art. 24.1 (adapted)

Lifting appliances moving along a fixed course
even where they do not move along guides which are rigid shall be considered as
lifts falling within the scope of this Directive.

ê 2006/42/EC
Art. 24.1

3.2. This Directive shall not apply to:

(a)        - lifting appliances whose speed is not greater than 0,15 m/s;

(b)        - construction site hoists;

(c)        - cableways, including funicular railways;

(d)        - lifts specially designed and constructed for military or police
purposes;

(e)        - lifting appliances from which work can be carried out;

(f)         - mine winding gear;

(g)        - lifting appliances intended for lifting performers during artistic
performances;

(h)        - lifting appliances fitted in means of transport;

(i)         - lifting appliances connected to machinery and intended exclusively
for access to workstations including maintenance and inspection points on the
machinery;

(j)         - rack and pinion trains;

(k)        - escalators and mechanical walkways.

ê 95/16/EC
(adapted)

5.3. Where, for
lifts Ö or safety
components for lifts Õ, the risks
referred to in this Directive are wholly or partly covered by specific Directives
Ö Union
legislation, and in particular Directive 2006/42/EC[20] and Directive 2004/108/EC[21], Õ this Directive
shall not apply or shall cease to apply in the case of such lifts Ö or safety
components for lifts Õ and such risks
as from application of these Ö that Õ specific Directives
Ö Union legislation. Õ

Article
2 [Article R1 of
Decision No 768/2008/EC]
Ö Definitions Õ

4. For the purposes of this Directive Ö the
following definitions apply Õ :

ê 2006/42/EC
Art. 24.1 (adapted)

Ö (1) 'lift’ means a
lifting appliance serving specific levels, having a carrier moving along guides
which are rigid and inclined at an angle of more than 15 degrees to the
horizontal, or a lifting appliance moving along a fixed course even where it
does not move along rigid guides; Õ

(2) A
'carrier' means a part of the lift by which persons and/or goods are supported
in order to be lifted or lowered,;

ê 95/16/EC
(adapted)

(3)- a 'model
lift' shall mean
Ö means Õ a
representative lift whose technical dossier Ö file Õ shows the way
in which the essential Ö health
and Õ safety
requirements Ö set out
in Annex I Õ will be met
for lifts which conform to the model lift defined by objective parameters and
which uses identical safety components Ö for lifts Õ,;

(4)- the ‘installer of a lift' shall mean Ö means Õ the natural or
legal person who takes responsibility for the design, manufacture, installation
and placing on the market of the lift and who affixes the CE marking and draws up the EC
declaration of conformity,;

–
«placing on the
market of the lift» shall occur when the installer first makes the lift
available to the user,

–
«safety component»
shall mean a component as listed in Annex IV,

–
the «manufacturer
of the safety components» shall mean the natural or legal person who takes
responsibility for the design and manufacture of the safety components and
who affixes the CE marking and draws up the EC declaration of conformity,

ò new

(5)
‘making available on the market’ means any supply of a safety component for
lifts for distribution or use on the Union market or any supply of a lift for
use on the Union market in the course of a commercial activity, whether in
return for payment or free of charge;

(6) 'placing on
the market' means the first making available of a lift or a safety component for
lifts on the Union market;

(7) 'manufacturer'
means any natural or legal person who manufactures a safety component for lifts
or has a safety component for lifts designed or manufactured and markets it
under his name or trademark;

(8) ‘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 specific tasks;

(9) ‘importer’
means any natural or legal person established within the Union who places a
safety component for lifts from a third country on the Union market;

(10) ‘distributor’
means any natural or legal person in the supply chain, other than the
manufacturer or the importer, who makes a safety component for lifts available
on the market;

(11) ‘economic
operators’ means the manufacturer or his authorised representative, the
importer or the distributor of a safety component for lifts or the installer;

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

(13) ‘technical
specification" means a document that prescribes technical requirements to
be fulfilled by a lift or a safety component for lifts;

(14) ‘conformity
assessment’ means the process demonstrating whether the essential health and
safety requirements set out in Annex I relating to a lift or a safety component
for lifts, process and system have been fulfilled;

(15) ‘conformity
assessment body’ means a body that performs conformity assessment activities
including calibration, testing, certification and inspection;

(16) ‘recall’
means any measure aimed at achieving the return of a safety component for lifts
that has already been made available to the installer;

(17) ‘withdrawal’
means any measure aimed at preventing a lift from being placed on the market or
a safety component for lifts from being made available on the market;

(18) ‘CE
marking’ means a marking by which the installer or the manufacturer indicates
that the lift or safety component for lifts are in conformity with the
applicable requirements set out in Union harmonisation legislation providing
for its affixing;

(19) ‘Union
harmonisation legislation’ means any Union legislation harmonising the
conditions for the marketing of products.

ê 95/16/EC (adapted)

ð new

Article 43

Ö Freedom
of movement Õ

1. Member States may
not prohibit, restrict or impede the placing
ð making available ï on the market or putting into service on their territory
of lifts and/or
ð the making
available on the market of ï safety components Ö for lifts on their territory Õ which comply with this Directive.

2. Member States may not prohibit, restrict or impede the
placing on the market of components ð not covered by Annex III ï which,
on the basis of a declaration by the manufacturer or his authorised
representative established in the Community Ö Union Õ ,
are intended to be incorporated into a lift covered by this Directive.

3.5. At trade fairs, exhibitions or demonstrations in particular, Member
States shall not prevent the showing of lifts or safety components Ö for
lifts Õ which
do not conform to the Community provisions in force Ö are not in conformity with this
Directive Õ, provided that a visible sign clearly indicates
that Ö they Õ such lifts or
safety components are
not in conformity and Ö will not be made available Õ are not for
sale until they
have been brought into conformity by the installer of the lift, the manufacturer of
the safety components or the latter's authorized representative established
in the Community. During demonstrations, adequate safety measures
shall be taken to ensure the protection of persons.

4. Without prejudice to
paragraphs 1, 2 and 3, the provisions of tThis
Directive shall not affect Member States' entitlement to lay down in conformity
with the Treaty Ö legislation of the Union Õ such requirements as they may deem necessary to ensure that persons
are protected when the lifts in question are put into service or used, provided
that this does not mean that the lifts are modified in a way not specified in the
Ö this Õ Directive.

Article 42
Ö Making available on the market Õ

1. Member States shall
take all appropriate measures to ensure that Ö the Õ - lifts covered by this Directive may be placed on
the market and put into service only if they are not liable to Ö do not Õ endanger the health or safety of persons or,
where appropriate, the safety of property, when properly installed and
maintained and used for their intended purpose.

Ö 2. Member States shall take all
appropriate measures to ensure that Õ - safety components Ö for lifts Õ covered by this Directive may be placed ð made
available ï on the market and put into service only if the
lifts in which they are to be installed are not liable to Ö do not Õ endanger the health or safety of persons or,
where appropriate, the safety of property when properly installed and
maintained and used for their intended purpose.

Article 53
Ö Essential health and safety requirements Õ

ê 95/16/EC

1.
Lifts covered by this Directive must satisfy the essential health and safety
requirements set out in Annex I.

ê 95/16/EC
(adapted)

2. The Ssafety components Ö for lifts Õ covered by this Directive must satisfy the
essential health and safety requirements set out in Annex I or enable the lifts
in which they are installed to satisfy Ö those Õ the said
essential requirements.

Article 6
Ö Buildings or constructions in which lifts
are installed Õ

1. 2. Member States shall take all appropriate
measures to ensure that the person responsible for work on the building or
construction and the installer of the lift, on the one hand, keep Ö both provide Õ each other Ö with the necessary information Õ
informed of the facts necessary for, and, on the other hand, take the appropriate steps Ö in order Õ to ensure the proper operation and safe use of the lift.

ê 95/16/EC

2. 3. Member States shall take all necessary measures
to ensure that shafts intended for lifts do not contain any piping or wiring or
fittings other than that necessary for the operation and safety of the lift.

ò new

CHAPTER II

OBLIGATIONS OF ECONOMIC
OPERATORS

Article
7 [Article R2 of Decision No
768/2008/EC]
Obligations of
installers

1. When placing a lift on the market or
putting a lift into service, installers shall ensure that it has been designed,
manufactured, installed and tested in accordance with the essential health and
safety requirements set out in Annex I.

2. Installers shall draw up the technical
file and carry out the applicable conformity assessment procedure referred to
in Article 16 or have it carried out.

Where the compliance of the lift with the
applicable requirements has been demonstrated by that procedure, the installer
shall draw up an EU declaration of conformity, ensure that it accompanies the
lift, and affix the CE marking.

3. The installer shall keep the required
technical file and the EU declaration of conformity and, where applicable, the
approval decision(s) for 10 years after the lift has been placed on the market.

4. When deemed appropriate with regard to
the risks presented by a lift, installers shall, to protect the health and
safety of consumers investigate, and, if necessary, keep a register of
complaints, of non-conforming lifts and shall keep distributors informed of any
such monitoring.

5. Installers shall ensure that lifts
bear a type, batch, serial number or other element allowing their
identification.

6. Installers shall indicate their name,
registered trade name or registered trade mark and the address at which they
can be contacted. The address must indicate a single point at which the
installer of lifts can be contacted.

7. Installers shall ensure that the lift
is accompanied by the instruction for use referred to in point 6.2 of Annex I,
in a language which can easily be understood by end-users, as determined by the
Member State in which the lift is installed.

8.
Installers who consider or have reason to believe that a lift which they have
installed is not in conformity with this Directive shall immediately take the
necessary corrective measures to bring that lift into conformity. Furthermore,
where the lift presents a risk, installers shall immediately inform the
competent national authorities of the Member States in which they installed the
lift to that effect, giving details, in particular, of the non-conformity and
of any corrective measures taken.

9.
Installers 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 lift, in a language which can be easily
understood by that authority.

They
shall cooperate with that authority, at its request, on any action taken to
eliminate the risks posed by lifts which they have installed.

Article
8 [Article R2 of Decision No
768/2008/EC]
Obligations of
manufacturers

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

2.
Manufacturers shall draw up the required technical file and carry out the
conformity assessment procedure referred to in Article 15 or have it carried
out

Where
compliance of the safety component for lifts with the applicable essential health
and safety requirements has been demonstrated by that procedure, the
manufacturer shall draw up an EU declaration of conformity, ensure that it
accompanies the safety component for lifts and affix the CE marking.

3.
The manufacturer shall keep the technical file and the EU declaration of
conformity and,
where applicable, the approval decision(s) for 10 years after the safety component
for lifts has been placed on the market.

4.
When deemed appropriate with regard to the risks presented by a safety
component for lifts, manufacturers shall, to protect the health and safety of
consumers, carry out sample testing of safety component for lifts made
available on the market, investigate, and, if necessary, keep a register of
complaints, of non-conforming safety component for lifts and recalls of the
safety component for lifts, and shall keep distributors and installers informed
of any such monitoring.

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

6.
Manufacturers shall indicate their name, registered trade name or registered
trade mark and the address at which they can be contacted on the safety
component for lifts or, where that is not possible, a label inseparably attached to the safety component for
lifts. The address must indicate a single point at which the manufacturers can
be contacted.

7.
Manufacturers shall ensure that the safety component for lifts is accompanied
by the instruction manual referred to in Point 6.1 of Annex I, in a language which can easily
be understood by end-users, as determined by the Member State concerned.

8.
Manufacturers who consider or have reason to believe that a safety component
for lifts which they have placed on the market is not in conformity with this
Directive shall immediately take the necessary corrective measures to bring
that safety component for lifts into conformity, to withdraw it or recall it,
if appropriate. Furthermore, where the safety component for lifts presents a
risk, manufacturers shall immediately inform the competent national authorities
of the Member States in which they made the safety components for lifts
available to that effect, giving details, in particular, of the non-conformity
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 safety components for lifts, in a language
which can be easily understood by that authority.

They
shall cooperate with that authority, at its request, on any action taken to
eliminate the risks posed by safety components for lifts which they have placed
on the market.

Article
9 [Article R3 of Decision No
768/2008/EC]
Authorised representatives

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

2. The obligations laid down in Article
8(1) and the drawing up of the technical file referred to in Article 8(2) shall
not form part of the authorised representative’s mandate.

3. 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, where
applicable, the approval decision(s) relating to the manufacturer's quality assurance system, and
the technical file at the disposal of the national surveillance authorities for
a period of 10 years after the safety component for lifts 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 safety
components for lifts;

(c)
cooperate with the competent national authorities, at their request, on any
action taken to eliminate the risks posed by the safety component for lifts
covered by the authorised representative’s mandate.

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

Obligations
of importers of safety components for lifts

1.
Importers shall place only compliant safety components for lifts on the market.

2.
Before placing a safety component for lifts on the market, importers shall
ensure that the appropriate conformity assessment procedure has been carried
out by the manufacturer. They shall ensure that the manufacturer has drawn up
the technical file, that the safety component for lifts bears the CE marking
and is accompanied by the EU declaration of conformity and the instruction manual
and that the manufacturer has complied with the requirements set out in Article
8(5) and 8(6).

Where
an importer considers or has reason to believe that a safety component for lifts is not in conformity with the
essential health and safety requirements set out in Annex I, he shall not
place the safety component for lifts on the market until it has been brought into conformity.
Furthermore, where the safety component for lifts 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 address at which they can be contacted on the safety component for lifts or, where that is not
possible, on its packaging or in a document accompanying the safety component.

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

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

6.
When deemed appropriate with regard to the risks presented by a safety
component for lifts, importers shall, to protect the health and safety of
consumers, carry out sample testing of safety components for lifts made
available on the market, investigate, and, if necessary, keep a register of
complaints, of non-conforming safety components for lifts and safety component
for lifts recalls, and shall keep distributors and installers informed of such
monitoring.

7.
Importers who consider or have reason to believe that a safety component for lifts which they have placed on the
market is not in conformity with this Directive shall immediately take the
corrective measures necessary to bring that safety component for lifts into conformity, to withdraw
it or recall it, if appropriate. Furthermore, where the safety component for lifts presents a risk, importers
shall immediately inform the competent national authorities of the Member
States in which they made the safety component for lifts available to that effect, giving
details, in particular, of the non-compliance and of any corrective measures
taken.

8. Importers
shall, for a period of 10 years after the safety component for lifts has been placed on the market, keep a copy of the EU
declaration of conformity and, where applicable, the approval decision(s) at
the disposal of the market surveillance authorities and ensure that the
technical file 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 safety
components
for lifts in a language which can be easily understood by that
authority. They shall cooperate with that authority, at its request, on any
action taken to eliminate the risks posed by safety components for lifts which they
have placed on the market.

Article
11 [Article R5 of Decision No
768/2008/EC]
Obligations of
distributors

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

2.
Before making a safety component for lifts available on the market,
distributors shall verify that the safety component for lifts bears the CE
marking, that it is accompanied by the EU declaration of conformity and by the
instruction manual and that the manufacturer and the importer have complied
with the requirements set out in Article 8(5) and 8(6), and Article 10(3).

Where
a distributor considers or has reason to believe that a safety component for
lifts is not in conformity with the essential health and safety requirements
set out in Annex 1, he shall not make the safety component for lifts available
on the market until it has been brought into conformity. Furthermore, where the
safety component for lifts 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 safety component for lifts is under
their responsibility, storage or transport conditions do not jeopardise its
compliance with the essential health and safety requirements set out in Annex
I.

4.
Distributors who consider or have reason to believe that a safety component for
lifts which they have made available on the market is not in conformity with
this Directive shall make sure that the corrective measures necessary to bring
that safety component for lifts into conformity, to withdraw it or recall it,
if appropriate, are taken. Furthermore, where the safety component for lifts
presents a risk, distributors shall immediately inform the competent national
authorities of the Member States in which they made the safety component for
lifts 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 safety components for lifts. They shall cooperate with that
authority, at its request, on any action taken to eliminate the risks posed by safety components for lifts which they have made
available on the market.

Article
12 [Article R6 of Decision No
768/2008/EC]
Cases in which the obligations of manufacturers apply to importers or
distributors

An
importer or distributor shall be considered a manufacturer for the purposes of
this Directive and he shall be subject to the obligations of the manufacturer
under Article 8 where he places a safety component for lifts on the market
under his name or trademark or modifies a safety component for lifts already
placed on the market in such a way that compliance with the requirements of
this Directive may be affected.

Article
13 [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 safety component for lifts;

(b)
any
economic operator to whom they have supplied a safety component for lifts.

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

ê 95/16/EC (adapted)

CHAPTER
III

Ö CONFORMITY
OF LIFTS AND SAFETY COMPONENTS FOR LIFTS Õ

Article 14 [Article R8 of Decision No
768/2008/EC]
Ö Presumption
of conformity Õ

1. Member States shall regard lifts and safety
components bearing the CE marking and accompanied by the EC declaration of
conformity referred to in Annex II as conforming to all the provisions of this
Directive, including the conformity assessment procedures laid down in Chapter
II.

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

ê 95/16/EC

2. Where a
national standard transposing a harmonized standard, the reference for which
has been published in the Official Journal of the European Communities, covers
one or more of the essential health and safety requirements:

–          lifts
constructed in accordance with that standard
shall be presumed to comply with the relevant essential requirements.

or

–          safety
components constructed in accordance with that standard shall be presumed
suitable to enable a lift on which they are correctly installed to comply with the relevant essential requirements .

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

ê 95/16/EC
(adapted)

3. Member States shall ensure that appropriate
measures are taken to enable both sides of industry to have an influence at
national level on the process of preparing and monitoring the harmonized
standards.

ò new

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

[2. Where a
harmonised standard satisfies the requirements which it covers and which are
set out in Annex I or Article 24, the Commission shall publish the references
of this standard in the Official Journal of the European Union.]

ê 95/16/EC (adapted)

Article 8 15
Ö Conformity assessment procedure for safety components for lifts Õ

1. Before placing safety components listed in
Annex IV on the market, the manufacturer of a safety component or his authorized
representative established in the Community must:

Ö Safety components for lifts shall be subject
to any of the following conformity
assessment procedures: Õ

(a)

(i) either submit the model of the safety
component for EC type-examination in accordance with Annex V and for
production checks by a notified body in accordance with Annex XI;

(ii) or submit the model of the safety component
for EC type-examination in accordance with Annex V and operate a quality
assurance system in accordance with Annex VIII for checking production;

(iii) or operate a full quality assurance system
in accordance with Annex IX;

Ö (a) the model of the safety component for lifts shall be submitted for EU type examination set out in Annex IV Part A and the
conformity to type shall be ensured with random checking of the safety
component for lifts set out in Annex
IX; Õ

Ö (b) the model
of the safety component for lifts shall be submitted for EU type
examination set out in Annex IV
Part A and be subject to a product quality assurance system in accordance with
Annex VI; Õ

Ö (c) full quality assurance system set out in Annex VII. Õ

(b) affix the CE marking on each safety component
and draw up a declaration of conformity containing the information listed in
Annex II, taking account of the specifications given in the Annex used (Annex
VIII, IX or XI as the case may be);

(c) keep a copy of the declaration of conformity
for 10 years from the date on which the safety component was last
manufactured.

ê 95/16/EC
(adapted)

Article 16
Ö Conformity
assessment procedure for lifts Õ

1.2. Before being placed Ö Lifts shall be subject to Õ on the market, a lift must have undergone one of the following Ö conformity assessment Õ procedures:

(i) either, if it was designed in accordance with
a lift having undergone an EC type-examination as referred to in Annex V, it
shall be constructed, installed and tested by implementing:

–
the final inspection referred to in Annex VI, or

–
the quality assurance system referred to in Annex XII, or

–
the quality assurance system referred to in Annex XIV.

The procedures for the design and construction
stages, on the one hand, and the installation and testing stages, on the other,
may be carried out on the same lift;

(ii) or, if it was designed in accordance with a
model lift having undergone an EC type-examination as referred to in Annex
V, it shall be constructed, installed and tested by implementing:

–
the final inspection referred to in Annex VI, or

–
the quality assurance system referred to in Annex XII, or

–
the quality assurance system referred to in Annex XIV;

(iii) or, if it was designed in accordance with
a lift for which a quality assurance system pursuant to Annex XIII was
implemented, supplemented by an examination of the design if the latter is not
wholly in accordance with the harmonized standards, it shall be installed and constructed and tested by
implementing, in addition:

–
the final inspection referred to in Annex VI, or

–
the quality assurance system in accordance with Annex XII, or

–
the quality assurance system in accordance with Annex XIV;

(iv) or, having undergone the unit verification
procedure, referred to in Annex X, by a notified body;

(v) or, having been subject to the quality
assurance system in accordance with Annex XIII, supplemented by an examination
of the design if the latter is not wholly in accordance with the harmonized
standards.

In the cases referred to in (i), (ii) and (iii)
above, the person responsible for the design must supply to the person
responsible for the construction, installation and testing all necessary
documents and information for the latter to be able to operate in absolute
security.

ê 95/16/EC
(adapted)

Ö (a) if they are designed and manufactured in
accordance with a model lift that has undergone an EU type-examination referred
to in Annex IV Part B, they shall be installed and tested by
carrying out any of the following procedures: Õ

Ö (i) the final inspection referred to in Annex V; Õ

Ö (ii) the product quality assurance system
referred to in Annex X; Õ

Ö (iii) the
production quality assurance system referred to in Annex XII;
Õ

Ö (b) if they
are designed and manufactured in accordance with a model lift for which a full
quality assurance system pursuant to Annex XI has been carried out,
supplemented by a design examination if the design is not wholly in accordance
with the harmonized standards, they shall be installed and tested by carrying
out any of the following procedures: Õ

Ö (i) the
final inspection referred to in Annex V; Õ

Ö (ii) the product quality assurance system in
accordance with Annex X; Õ

Ö (iii) the
production quality assurance system in accordance with Annex XII; Õ

Ö (c) the
unit verification procedure, referred to in Annex VIII; Õ

Ö (d) the
full quality assurance system referred to in Annex XI, supplemented by a design
examination if the design is not wholly in accordance with the harmonized
standards. Õ

Ö 2. In the
cases referred to in point (a) and (b) of paragraph 1, the person responsible
for the design and manufacture of the lift must supply to the person
responsible for the installation and testing of the lift all the necessary
documents and information to enable the latter to ensure correct and safe
installation and testing of the lift. Õ

ê 95/16/EC

3. In all the
cases referred to in paragraph 2:

–          the
installer shall affix the CE marking on the lift and draw up a declaration of
conformity containing the information listed in Annex II, taking account of the
specifications given in the Annex used (Annex VI, X, XII, XIII or XIV, as the case may be),

–          the installer must keep a copy of the declaration of conformity for 10
years from the date on which the lift was placed on the market,

–          the
Commission, the Member States and the other notified bodies may, on request,
obtain from the installer a copy of the
declaration of conformity and reports of the tests involved in the final
inspection.

4. (a) Where the
lifts or safety components are subject to other Directives concerning other
aspects and which also provide for the affixing of the CE marking, the
latter shall indicate that the lift or safety component is also presumed to
conform to the provisions of those other Directives.

(b)
However, where one or more of these Directives allows the manufacturer, during
a transitional period, to choose which arrangements to apply, the CE marking
shall indicate conformity only to the Directives applied by the installer of
the lift or the manufacturer of the safety components. In this case,
particulars of the Directives applied, as published in the Official Journal of the European Communities, must be given in the
documents, notices or instructions required by the Directives and accompanying
the lift or safety component.

5. Where neither
the installer of the lift nor the manufacturer of the safety component nor
his authorized representative established in the Community has complied with
the obligations of the preceding paragraphs, those obligations shall devolve
upon whomsoever places the lift or the safety component on the market in the
Community. The same obligations shall apply
to whomsoever manufactures the lift or safety component for his own use.

ê 95/16/EC
(adapted)

3. All permitted
variations between the model lift and the lifts forming part of the lifts
derived from the model lift must be clearly specified (with maximum and minimum
values) in the technical dossier Ö file Õ.

4. By calculation and/or
on the basis of design plans it is permitted to demonstrate the similarity of a
range of equipment to satisfy the essential Ö health
and Õ safety
requirements Ö set out
in Annex I Õ.

Article 17 [Article R10 of Decision No
768/2008/EC]

Ö EU declaration of conformity Õ

ò new

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

2.
The EU declaration of conformity shall have the model structure set out in Annex
II, shall contain the elements specified in the relevant modules set out in
Annex V, VIII, X, XI or XII, and shall be continuously updated. It shall be
translated into the language or the languages required by the Member State on
which market the lift or the safety component for lifts is placed or made
available.

3.
Where a lift or the safety component for lifts is subject to more than one
Union act requiring EU declaration of conformity, a single EU declaration of
conformity shall be draw up in respect of all such Union acts. That declaration
shall contain the identification of the acts concerned including the
publication references.

4. By
drawing up the EU declaration of conformity, the manufacturer shall assume
responsibility for the compliance of the safety component for lifts and the installer shall
assume responsibility for the compliance of the lift.

ê 95/16/EC (adapted)

CHAPTER III

CE marking

Article 18 [Article R11 of Decision No
768/2008/EC]
Ö General principles of the CE marking Õ

ò new

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

ê 95/16/EC (adapted)

Article 1910 [Article R12 of Decision No 768/2008/EC]
 Ö Rules
and conditions for affixing the CE marking and other markings Õ

1. The CE marking shall consist of the initials
CE. Annex III sets out the model to be used.

1.2. The CE marking shall be affixed Ö visibly, legibly and indelibly Õ to every Ö each Õ lift
car distinctly and
visibly in accordance with Section 5 of Annex I and shall be
affixed on each of the safety components Ö for
lifts Õ listed in Annex III IV
or, where that is not possible, on a label inseparably attached to the safety
component.

3. The affixing on the lifts or safety components
of markings which are likely to mislead third parties as to the meaning and
form of the CE marking shall be prohibited. Any other marking may be affixed
to the lifts or safety components, provided that the visibility and legibility
of the CE marking are not thereby reduced.

4. Without prejudice to Article 7:

(a)          where a Member State establishes
that the CE marking has been affixed
irregularly, the installer of the lift, the manufacturer of the safety
component or the authorized representative of the latter established within the
Community shall be obliged to make the product conform as regards the provisions
concerning the CE marking and to end the infringement under the conditions
imposed by the Member State;

(b)          should non-conformity persist, the
Member State must take all appropriate measures to restrict or prohibit the
placing on the market of the safety
component in question or to ensure that it is withdrawn from the market and
prohibit the lift from being used and inform the other Member States in
accordance with the procedures laid down in Article 7 (4).

ò new

2. The CE marking
shall be affixed before the lifts or the safety components for lifts are placed
on the market.

ê 95/16/EC
(adapted)

Ö3. The CE
marking on lifts shall be followed by the identification number of the notified
body involved in the following conformity assessment procedures: Õ

Ö (a) the
final inspection referred to in Annex V or approval of the quality assurance
system (referred to in Annex X, XI or XII); Õ

Ö (b) the
unit verification procedure, referred to in Annex VIII; Õ

Ö (c) the
approval of the full quality assurance system referred to in Annex XI. Õ

Ö 4. The CE
marking on safety components for lifts shall be followed by the identification
number of the notified body involved in the following conformity assessment
procedures: Õ

Ö (a) the
approval of the product quality assurance system referred to in Annex VI; Õ

Ö (b) the
approval of the full quality assurance system referred to in Annex VII. Õ

ò new

5.
The identification number of the notified body shall be affixed by the body
itself or, under its instructions, by the manufacturer or by his authorised
representative or by the installer.

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

ê 95/16/EC (adapted)

Article 9

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

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

2. Member States shall apply the criteria laid
down in Annex VII in assessing the notified bodies. Bodies meeting the
assessment criteria laid down in the relevant harmonized standards shall be
presumed to fulfil the criteria laid down in Annex VII.

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

ò new

CHAPTER IV

NOTIFICATION OF CONFORMITY
ASSESSMENT BODIES

Article 20 [Article R13 of Decision No 768/2008/EC]
Notification

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

Article 21 [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 22. 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 22 [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 23 [Article R16 of Decision No 768/2008/EC]
Information obligation on notifying authorities

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

The
Commission shall make that information publicly available.

Article 24 [Article R17 of Decision No 768/2008/EC]
Requirements relating to notified bodies

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

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

3. A
conformity assessment body shall be a third-party body independent of the
organisation or the lifts or safety components for lifts 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 lifts or safety components for lifts 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, purchaser, owner, user or maintainer of safety components for lifts
which they
assess, nor the authorised representative of any of those parties.

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 lifts which they assess.

This
shall not preclude the
use of assessed lifts
or safety components for lifts that are necessary for the operations of the conformity
assessment body or the use of such lifts or safety components for lifts for personal purposes.

This
does not preclude the possibility of exchange of technical information between
the manufacturer or the installer and the body.

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 lifts or safety components for lifts,
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.

A
conformity assessment body shall ensure that the activities of its subsidiaries
or subcontractors do not affect the confidentiality, objectivity or
impartiality of its conformity assessment activities.

5. A
conformity assessment body and its 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 Article 15 and 16 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 lifts or safety components for lifts 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 lift or safety component for lifts technology in question and the
mass or serial nature of the production process.

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

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

(a)
sound technical and vocational training covering all the conformity assessment
activities for which the conformity assessment body has been notified;

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

(c)
appropriate knowledge and understanding of the essential health and safety
requirements set out in Annex I, of the applicable harmonised standards and of
the relevant provisions of Union harmonisation legislation and of its relevant
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 body, its management and the
personnel responsible for carrying out the conformity assessment tasks shall be
guaranteed.

The
remuneration of the top level management and assessment personnel of the
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 according
to Article 15 and 16 or any provision of national law giving effect to it,
except in relation to the competent authorities of the Member State in which
its activities are carried out. Proprietary rights shall be protected.

11. Conformity
assessment bodies shall participate in, or ensure that their assessment
personnel are informed of, the relevant standardisation activities.

The
body shall participate in or be represented in the activities of the
Coordination Group of Notified Bodies for Lifts established under Article 36
and apply as general guidance the recommendations for use produced as a result
of the work of that group.

Article 25 [Article R18 of Decision No 768/2008/EC]

Presumption of conformity of a notified body

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 24 in
so far as the applicable harmonised standards cover those requirements.

Article 26 [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 24
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 Article
15 and 16.

Article 27 [Article R22 of Decision No 768/2008/EC]

Application for notification

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

2. That application shall be accompanied by a description
of the conformity assessment procedures for lifts or for safety components for
lifts for which the 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 24.

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 24.

Article 28 [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 24.

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 procedures for lifts or for safety components for lifts
concerned and the relevant attestation of competence.

4. Where a notification is not based on an accreditation
certificate as referred to in Article 27(2), the notifying authority shall
provide the Commission and the other Member States with documentary evidence
which attests to the conformity assessment body's competence and the
arrangements in place to ensure that that body will be monitored regularly and
will continue to satisfy the requirements laid down in Article 24.

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

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

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

Article 29 [Article R24 of Decision No 768/2008/EC]

Identification
numbers and lists of notified bodies

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

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

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

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

Article 30 [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 24, or that it is failing to fulfil its obligations, the notifying
authority shall restrict, suspend or withdraw notification as appropriate,
depending on the seriousness of the failure to meet those requirements or
fulfil those obligations. It shall immediately inform the Commission and the
other Member States accordingly.

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

Article 31 [Article R26 of Decision No 768/2008/EC]

Challenge
to the competence of notified bodies

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

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

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

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

Article 32 [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 Article 15 and 16.

2. Conformity
assessments shall be carried out in a proportionate manner, avoiding
unnecessary burdens for economic operators. Notified 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 lift or safety
component for lifts 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 conformity of the lifts or the safety components
for lifts with the provisions of this Directive.

3. Where
a notified body finds that the essential health and safety requirements set out
in Annex I or corresponding harmonised standards have not been met by an
installer or a manufacturer, it shall require the installer or the 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 or an approval decision, as appropriate, a notified body finds that
a lift or a safety component for lifts no longer complies, it shall require the
installer or the manufacturer to take appropriate corrective measures and shall
suspend or withdraw the certificate or the approval decision 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 or approval
decision(s), as appropriate.

Article 33 [Article 4(7) of Decision No 768/2008/EC]

Appeal
against decisions of notified bodies

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

Article 34 [Article R28 of Decision No 768/2008/EC]

Information
obligation on notified bodies

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

(a)
any
refusal, restriction, suspension or withdrawal of a certificate or approval
decision;

(b)
any
circumstances affecting the scope of and conditions for notification;

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

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

2. Notified
bodies shall provide the other bodies notified under this Directive carrying
out similar conformity assessment activities for lifts or safety components for
lifts with relevant information on issues relating to negative and, on request,
positive conformity assessment results.

Article 35 [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 36 [Article R30 of Decision No 768/2008/EC]

Coordination
of notified bodies

The
Commission shall ensure that appropriate coordination and cooperation between
bodies notified under this Directive are put in place and properly operated in
the form of a Coordination Group of Notified Bodies for Lifts.

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

CHAPTER V

UNION MARKET
SURVEILLANCE AND CONTROL OF LIFTS OR
SAFETY COMPONENTS FOR LIFTS ENTERING THE UNION MARKET AND SAFEGUARD PROCEDURES

Article
37

Union market surveillance and control of lifts or safety components for
lifts entering the Union market

Article 15(3) and Articles 16-29 of Regulation (EC) No
765/2008 shall apply to lifts and safety components for lifts.

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

Procedure for dealing with lifts or safety
components for lifts presenting a risk at national level

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

Where, in the course of the evaluation referred to in the
first subparagraph, the market surveillance authorities find that a lift does
not comply with the requirements laid down in this Directive, they shall,
without delay, require the installer to take all appropriate corrective action
to bring the lift into compliance with those requirements within a reasonable
period commensurate with the nature of the risk, as they may prescribe.

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

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

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

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

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

4. Where the installer does not take adequate corrective
action within the period referred to in the second subparagraph of paragraph 1,
the market surveillance authorities shall take all appropriate provisional
measures to restrict the placing on their national market or the putting into
service.

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

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

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

(a) failure of the lift or the safety component
for lifts to meet the essential health and        safety requirements set out
in Annex I;

(b) shortcomings in the harmonised standards
referred to in Article 14 conferring a         presumption of conformity.

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

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

8. Member States shall ensure that appropriate restrictive
measures are taken, without delay, in respect of the lift or the safety
component for lifts concerned.

Article 39 [Article R32 of Decision No 768/2008/EC]

Union safeguard procedure

1. Where, on completion of the procedure set out in Article
38(3) and 38(4), objections are raised against a measure taken by a Member
State, or where the Commission considers a national measure to be contrary to
Union legislation, the Commission shall, without delay, enter into consultation
with the Member States and the relevant economic operator or operators and
shall evaluate the national measure. On the basis of the results of that
evaluation, the Commission shall decide whether the national measure is
justified or not.

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

2. If the national measure relating to a lift is considered
justified, all Member States shall take the measures necessary to ensure that
the non-compliant lift is restricted to be placed on their national market or
put into service.

If the national measure relating to a safety component for
lifts is considered justified, all Member States shall take the measures
necessary to ensure that the non-compliant safety component for lifts is
withdrawn from their market.

The Member States shall inform the Commission accordingly.

If the national measure is considered unjustified, the
Member State concerned shall withdraw the measure.

3. Where the national measure is considered justified and
the non-compliance of the lift or the safety component for lifts is attributed
to shortcomings in the harmonised standards referred to in Article 38(5)(b) of
this Directive, the Commission shall apply the procedure provided for in
Article 8 of Regulation (EU) No [../..] [ on European Standardisation].

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

Compliant
lift or
safety component for lifts which present a risk to health and safety

1. Where, having performed an evaluation under Article 38(1),
a Member State finds that although a lift or safety components for lifts is in
compliance with this Directive, it presents a risk to the health or safety of
persons or to other aspects of public interest protection, it shall require the
relevant economic operator to take all appropriate measures to ensure that the
lifts or safety component for lifts concerned, when placed on the market, no
longer presents that risk, to withdraw the safety component for lifts from the
market or to recall it or to restrict the placing the
lift on the market or the putting it into service within a
reasonable period, commensurate with the nature of the risk, as it may
prescribe.

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

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

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

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

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

Formal
non-compliance

1. Without prejudice to Article 38, where a Member State
makes one of the following findings, it shall require the installer or the
manufacturer, distributor or importer of a safety component for lifts to put an
end to the non-compliance concerned:

(a) the CE marking has been affixed in violation Article 30
of Regulation (EC) No 765/2008 or of Article 18 and 19 of this Directive;

(b) the CE marking has not been affixed;

(c) the EU declaration of conformity has not been drawn up;

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

(e) the technical file referred to in Annexes IV Part A and
Part B, VII, VIII and XI is either not available or not complete.

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

ê 95/16/EC
(adapted)

Article 6

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

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

ê 95/16/EC

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

ê 1882/2003
Art. 1 and Annex I.10 (new)

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

Where reference is made to this
paragraph, Articles 3 and 7 of Decision 1999/468/EC[22] shall apply, having regard to the provisions of
Article 8 thereof.

The Committee shall adopt its rules
of procedure.

ê 95/16/EC

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

Article 7

1. Where a Member
State ascertains that a lift or a safety component bearing the CE marking and
used in accordance with its intended purpose is liable to endanger the safety
of persons and, where appropriate, of property, it shall take all
appropriate measures to withdraw it from the market, to prohibit it from being
placed on the market or put into service or to restrict its free movement

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

(a)        failure
to satisfy the essential requirements referred to in Article 3;

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

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

2. The Commission
shall enter into consultation with the parties concerned as soon as possible.
Where, after such consultation, the Commission finds that:

- the measures are justified, it shall
immediately so inform the Member State which took the initiative and the other
Member States; where the decision referred to in paragraph 1 is based on
shortcomings in the standards, the Commission shall, after consulting the
parties concerned, bring the matter before
the Committee referred to in Article 6 (1), if the Member State which has taken
the decision intends to maintain it, and shall initiate the procedure referred
to in Article 6 (1),

- the measures are unjustified, it shall immediately
so inform the Member State which took the initiative and the installer of the
lift, the manufacturer of the safety components or the latter's authorized
representative established in the Community.

3. Where a lift or
safety component which does not comply bears the CE marking, the competent
Member State shall take appropriate action against whomsoever affixed the
marking and shall so inform the Commission and the other Member States.

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

ò new

CHAPTER VI

DELEGATING POWER

Article 42

Delegating
power

The Commission shall
be empowered to adopt delegated acts in accordance with Article 43 concerning
adaptations of Annex III to technical progress and new scientific evidence.

Article 43

Exercise of
the delegation

1. The power to
adopt delegated acts is conferred on the Commission subject to the conditions
laid down in this Article.

2. The delegation
of power referred to in Article 42 shall be conferred for an indeterminate
period of time from the date specified in Article 49 [entry into force of
the directive].

3. The delegation
of powers referred to in Article 42 may be revoked at any time by the European
Parliament or by the Council. A decision of revocation shall put an end to the
delegation of the power specified in that decision. It shall take effect the
day following the publication of the decision in the Official Journal of the
European Union or at a later date specified therein. It shall not affect
the validity of any delegated acts already in force.

4. As soon as it
adopts a delegated act, the Commission shall notify it simultaneously to the
European Parliament and to the Council.

5. A delegated
act adopted pursuant to Article 42 shall enter into force only if no objection
has been expressed either by the European Parliament or the Council within a
period of 2 months of notification of that act to the European Parliament and
the Council or if, before the expiry of that period, the European Parliament
and the Council have both informed the Commission that they will not object.
That period shall be extended by 2 months at the initiative of the European
Parliament or the Council.

ê 95/16/EC (adapted)

CHAPTER IV VII

Ö TRANSITIONAL AND Õ FINAL PROVISIONS

Article 11

Any decision taken pursuant to this Directive
which restricts:

- the placing
on the market and/or putting into service and/or use of a lift,

- the placing
on the market and/or putting into service of a safety component,

shall state the exact grounds on which it is
based. Such a decision shall be notified as soon as possible to the party
concerned, who shall at the same time be informed of the legal remedies
available to him under the laws in force in the Member State concerned and
of the time limits to which such remedies are subject.

ò new

Article
44

Penalties

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

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

Member
States shall notify those provisions to the Commission by [...the date set out
in the second subparagraph of Article 46(1)] and shall notify it without
delay of any subsequent amendment affecting them.

ê 95/16/EC (adapted)

Article 12

The Commission shall take the necessary steps to
have information on all the relevant decisions relating to the
implementation of this Directive made available.

Article 45
Ö Transitional and final provisions Õ

ò new

Member
States shall not impede the making available on the market or putting into
service of lifts or safety components for lifts covered by Directive 95/16/EC
which are in conformity with that Directive and which were placed on the market
before [the date set out in the second subparagraph of Article 46(1)].

Certificates of
conformity issued under Directive 95/16/EC shall be valid under this Directive
unless they expire before that date.

ê 95/16/EC
(adapted)

ð new

Article
46
 Ö Transposition Õ

1. Member States shall adopt and publish, Ö by Õ ð [day (generally the last day of a
month)/month/year = 2 years after this adoption] ï Ö at the
latest, Õ the laws,
regulations and administrative provisions necessary to comply with this Directive
Ö Articles:
[Article 2(5)-2(19), Articles: 7-14, Articles: 17-18, Article 19(5), Articles:
20-45, Article 46(1), Article 47-49] and Annexes: [Annex II Part A Points: (f),
(k), (l), (m), Annex II Part B Points: (d), (j), (k), (l), Annex IV Part A
Points: 2(e), 3(c), 3(e), 3(g), Points: 4(b)-(e), Points: 5-9, Annex IV Part B
Points: 2(e), 3(c), 3(e), 3(h), Points: 4(c)-(e), Point 5 paragraphs: 2-4,
Points: 6-9, Annex V Point 3.3(b), Points: 6-7, Annex VI Points: 3.1(a)-(c),
Point 3.3 paragraph 4 -5, Point 4.3, Points: 6-7, Annex VII Points: 3.1(a)-(b),
3.1(d), 3.1(f), Point 3.3, Point 4.2, Point 6, Annex VII Points: 3(c)-(d), 3(g),
Annex VII Point 4, Annex IX Points: 3(a)-(d), Annex X Points: 3.1(a), 3.1(e),
Point: 3.4, Points: 6-7, Annex XI Points: 3.1(a)-(c), 3.1(e), Points: 3.3.3,
3.3.4, Points: 3.4 -3.5, Point 5(b) Point 6, Annex XII Point 3.1(a), Point 3.3,
Point 6]. [The articles and annexes which have been changed as to the
substance by comparison with the earlier Directive]. Õ by 1 January 1997.
They shall forthwith inform Ö communicate toÕ the Commission
thereof
Ö the text
of those provisions and a correlation table between those provisions and this
Directive. Õ

ð They shall apply those provisions
from [day (generally the first day of a month)/month/year = day after the
date mentioned in first subparagraph]. ï

When Member States adopt these measures Ö those
provisions Õ, they shall
contain a reference to this Directive or shall be accompanied by such reference
on the occasion of their official publication. The methods of making such reference shall be laid
down by Member States Ö They
shall also include a statement that references in existing laws, regulations
and administrative provisions to the directive repealed by this Directive shall
be construed as references to this Directive. Member States shall determine how
such reference is to be made and how the statement is to be formulated. Õ

Member States
shall apply these measures with effect from 1 July 1997.

2. Until 30 June
1999 Member States shall allow:

–          the
placing on the market and putting into
service of lifts,

–          the
placing on the market and putting into service of safety components,

which conform to
the provisions in force in their territories on the date of adoption of this
Directive.

ê 95/16/EC (adapted)

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

Article 16 47
Ö Reporting Õ

ê 95/16/EC

No
later than 30 June 2002, the Commission shall, in consultation with the
Committee referred to in Article 6 (3) and on the basis of reports provided by
the Member States, re-examine the functioning of the procedures laid down in
this Directive and, if necessary, submit any proposals for appropriate
amendments.

ò new

[By ... and
every 5 years after that date] Member States shall submit to the Commission reports on the
application of this Directive.

ê 95/16/EC (adapted)

Article 13 48
Ö Repeal Õ

Directive 84/528/EEC and Directive 84/529/EEC are
hereby repealed with effect from 1 July 1999.

Article 14

With regard to the aspects concerning the
installation of the lift, this Directive is a Directive within the meaning
of Article 2 (3) of
Directive 89/106/EEC.

ê 95/16/EC

ð new

ð Directive 95/16/EC, as amended by
the acts listed in Annex XIII, Part A, is repealed with effect from the date
set out in the second subparagraph of Article 46(1) of this Directive, without
prejudice to the obligations of the Member States relating to the time limits
for transposition into national law of the Directives set out in Annex XIII,
Part B. ï

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

ê 95/16/EC
(adapted)

Article 49
 Ö Entry into force Õ

ê95/16/EC
(adapted)

ð new

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

Ö Articles:
[Article 1, Article 2(1)-2(5), Articles: 3-6, Articles: 15-16, Article
19(1)-19(4), Article 45, Article 46(2), Article 50] and Annexes: [Annex I,
Annex II Part A Points: (a), (b), (c), (d), (e), (g), (h), (i), (j), Annex II
Part B Points: (a), (b), (c), (e), (f), (g), (h), (i), Annex III, Annex IV Part
A Points: 1, 2(a)-(d), 3(a)-(b), 3(d), 3(f), 3(h)-(i), Annex IV Part A Point 4(a),
Points 10-11, Annex IV Part B Points: 1, 2(a)-(d), 3(a)-(b), 3(d), 3(f)-(g) 3(i)-(j),
Points: 4(a)-(b), Point 5 paragraph 1, Points: 10-11, Annex V Points: 1-3.2,
Point 3.3(a), Points: 3.4-5, Annex VI Points: 1-2, Point 3.1(d)-(f), Point 3.2,
Point 3.3 paragraphs: 1-3, Points: 3.4-4.2, Point 5, Annex VII Points 1-2,
Points: 3.1(c), 3.1(e), Point 3.2, Point 3.4, Point 4.1, Points: 4.3-5, Point
7, Annex VII Points: 1-2, Points: 3(a)-(b), 3(e)-(f), 3(h), Points: 5-6, Annex
IX Points: 1-2, Points: 4-7, Annex X Points: 1-2, Points: 3.1(b)-(d), Points:
3.2-3.3, Points: 4-5, Annex XI Points: 1-2, Point: 3.1(d), Point 3.2, Point
3.3.1, Point 4, Point 5(a), 5(c), 5(d), Point 7, Annex XII Points: 1-2,
Points 3.1(b)-(d), Point 3.2, Point 3.4, Points: 4-5, Point 7]. [The
articles and annexes which are unchanged by comparison with the earlier
Directive] shall apply from [the date set out in the second subparagraph
of Article 46(1)]. Õ

ê 95/16/EC

Article 5017

This Directive is addressed to the Member States.

Done at [...],

For the European Parliament                       For
the Council

The
President                                                 The President

ê 95/16/EC (adapted)

ANNEX I

ESSENTIAL
HEALTH AND SAFETY REQUIREMENTS RELATING TO
THE DESIGN AND CONSTRUCTION OF LIFTS AND SAFETY COMPONENTS

PRELIMINARY REMARKS

1. Obligations under
essential health and safety requirements apply only where Ö the
corresponding risk exists for Õthe lift or safety component Ö for lifts Õ is subject to the hazard in
question when used as intended by the installer of the lift or the manufacturer of the safety
components.

2. The essential health
and safety requirements contained in the Directive are imperatives. However,
given the present state of the art, the objectives which they lay down may not
be attainable. In such cases, and to the greatest extent possible, the lift or
safety components Ö for lifts Õ must be designed and built in such a way as to
approximate to those objectives.

3. The safety-component
manufacturer and the installer of the lift are under an obligation Ö to carry out Õ assess the hazards Öa risk
assessment Õ in order to identify all those Ö the risks Õ which apply to their products; they must then design and
construct them taking account of the assessment.

ê 95/16/EC

4. In
accordance with Article 14, the essential requirements laid down in Directive
89/106/EEC, not included in this Directive, apply to lifts.

ê 95/16/EC
(adapted)

1. GENERAL

1.1. Application
of Directive 89/392/EEC, as amended by Directives 91/368/EEC, 93/44/EEC
and 93/68/EEC2006/42/EC.

Where the relevant hazard Ö risk Õ exists and is not dealt with in this Annex, the essential
health and safety requirements of Annex I to Directive 89/392/EEC
2006/42/EC[23] of
the European Parliament and of the Council apply. The essential
Ö health and safety Õ requirements
of Section
Point 1.1.2 of Annex I to Directive 89/392/EEC
2006/42/EC must apply in any event.

ê 2006/42/EC Art. 24.2

1.2. Carrier

The carrier of each
lift must be a car. This car must be designed and constructed to offer the
space and strength corresponding to the maximum number of persons and the rated
load of the lift set by the installer.

Where the lift is intended
for the transport of persons, and where its dimensions permit, the car must be
designed and constructed in such a way that its structural features do not
obstruct or impede access and use by disabled persons and so as to allow any
appropriate adjustments intended to facilitate its use by them.

ê 95/16/EC (adapted)

1.3. Means of suspension and means of support

The means of suspension
and/or support of the car, its attachments and any terminal parts thereof must
be selected and designed so as to ensure an adequate level of overall safety
and to minimize the risk of the car falling, taking into account the conditions
of use, the materials used and the conditions of manufacture.

Where ropes or chains
are used to suspend the car, there must be at least two independent cables or
chains, each with its own anchorage system. Such ropes and chains must have no
joins or splices except where necessary for fixing or forming a loop.

1.4. Control of
loading (including overspeed)

1.4.1. Lifts must be so
designed, constructed and installed as to prevent normal starting if the rated
load is exceeded.

1.4.2. Lifts must be
equipped with an overspeed governor.

These requirements do
not apply to lifts in which the design of the drive system prevents overspeed.

1.4.3. Fast lifts must
be equipped with a speed-monitoring and speed-limiting device.

1.4.4. Lifts driven by
friction pulleys must be designed so as to ensure stability of the traction
cables on the pulley.

1.5. Machinery

1.5.1. All passenger
lifts must have their own individual lift machinery. This requirement does not
apply to lifts in which the counterweights are replaced by a second car.

1.5.2. The installer of
the lift must ensure that the lift machinery and the associated devices of a
lift are not accessible except for maintenance and in emergencies.

1.6. Controls

1.6.1. The controls of
lifts intended for use by unaccompanied disabled persons must be designed and
located accordingly.

1.6.2. The function of
the controls must be clearly indicated.

1.6.3. The call
circuits of a group of lifts may be shared or interconnected.

1.6.4. Electrical
equipment must be so installed and connected that:

(a)- there can be no possible confusion with
circuits which do not have any direct connection with the lift,;

(b)- the power supply can be switched while on load,;

(c)- movements of the lift are dependent on
electrical safety devices in a separate electrical safety circuit,;

(d)- a fault in the electrical installation does not
give rise to a dangerous situation.

2. hazard
TO
Ö RISKS
FOR Õ PERSONS OUTSIDE THE CAR

2.1. The lift must be
designed and constructed to ensure that the space in which the car travels is
inaccessible except for maintenance or in emergencies. Before a person enters
that space, normal use of the lift must be made impossible.

2.2. The lift must be
designed and constructed to prevent the risk of crushing when the car is in one
of its extreme positions.

The objective will be
achieved by means of free space or refuge beyond the extreme positions.

However, in specific
cases, in affording Member States the possibility of giving prior approval,
particularly in existing buildings, where this solution is impossible to
fulfil, other appropriate means may be provided to avoid this risk.

2.3. The landings at
the entrance and exit of the car must be equipped with landing doors of
adequate mechanical resistance for the conditions of use envisaged.

An interlocking device
must prevent during normal operation:

(a)- starting movement of the car, whether or not
deliberately activated, unless all landing doors are shut and locked,;

(b)- the opening of a landing door when the car is
still moving and outside a prescribed landing zone.

However, all landing
movements with the doors open shall be allowed in specified zones on condition
that the levelling speed is controlled.

3. hazard
TO Ö RISKS
FOR Õ PERSONS IN THE CAR

3.1. Lift cars must be
completely enclosed by full-length walls, fitted floors and ceilings included,
with the exception of ventilation apertures, and with full-length doors. These
doors must be so designed and installed that the car cannot move, except for
the landing movements referred to in the third subparagraph of Section
Point 2.3, unless the doors are closed, and comes to a halt if
the doors are opened.

The doors of the car
must remain closed and interlocked if the lift stops between two levels where
there is a risk of a fall between the car and the shaft or if there is no
shaft.

3.2. In the event of a
power cut or failure of components the lift must have devices to prevent free
fall or uncontrolled upward movements of the car.

The device preventing
the free fall of the car must be independent of the means of suspension of the
car.

This device must be
able to stop the car at its rated load and at the maximum speed anticipated by
the installer of the lift. Any stop occasioned by this device must not cause
deceleration harmful to the occupants whatever the load conditions.

3.3. Buffers must be
installed between the bottom of the shaft and the floor of the car.

In this case, the free
space referred to in Section Point 2.2 must be measured with the
buffers totally compressed.

This requirement does
not apply to lifts in which the car cannot enter the free space referred to in Section
Point 2.2 by reason of the design
of the drive system.

3.4. Lifts must be so
designed and constructed as to make it impossible for them to be set in motion
if the device provided for in Section Point 3.2 is not in an operational position.

4. OTHER hazards
Ö risks Õ

4.1. The landing doors
and car doors or the two doors together, where motorized, must be fitted with a
device to prevent the risk of crushing when they are moving.

4.2. Landing doors,
where they have to contribute to the protection of the building against fire,
including those with glass parts, must be suitably resistant to fire in terms
of their integrity and their properties with regard to insulation (containment
of flames) and the transmission of heat (thermal radiation).

4.3. Counterweights
must be so installed as to avoid any risk of colliding with or falling on to
the car.

4.4. Lifts must be
equipped with means enabling people trapped in the car to be released and
evacuated.

4.5. Cars must be
fitted with two-way means of communication allowing permanent contact with a
rescue service.

4.6. Lifts must be so
designed and constructed that, in the event of the temperature in the lift
machine exceeding the maximum set by the installer of the lift, they can
complete movements in progress but refuse new commands.

4.7. Cars must be
designed and constructed to ensure sufficient ventilation for passengers, even
in the event of a prolonged stoppage.

4.8. The car should be
adequately lit whenever in use or whenever a door is opened; there must also be
emergency lighting.

4.9. The means of
communication referred to in Section Point 4.5 and the emergency lighting
referred to in Section Point
4.8 must be designed and constructed so as to function even without the normal
power supply. Their period of operation should be long enough to allow normal
operation of the rescue procedure.

4.10. The control circuits of lifts which
may be used in the event of fire must be designed and manufactured so that
lifts may be prevented from stopping at certain levels and allow for priority
control of the lift by rescue teams.

5. MARKING

5.1. In addition to the minimum particulars
required for any machine pursuant to Section
Point
1.7.3 of Annex I to Directive 89/392/EEC
2006/42/EC,
each car must bear an easily visible plate clearly showing the rated load in
kilograms and the maximum number of passengers which may be carried.

5.2. If the lift is
designed to allow people trapped in the car to escape without outside help, the
relevant instructions must be clear and visible in the car.

ê 95/16/EC (adapted)

ð new

6. INSTRUCTIONS FOR USE

6.1. The safety
components Ö for
lifts Õ referred to in Annex IV III must be accompanied by an
instruction manual drawn up ð in a
language which can be easily understood by consumers and other end-users, as
determined by ï in an official
language of the Member State of the lift installer or another Community
language acceptable to him ð concerned ï , so that: Ö the following can be carried out
effectively and without danger: Õ

(a)- assembly;,

(b)- connection;,

(c)- adjustment;,
and

(d)- maintenance.,

can be carried out effectively and without danger.

6.2. Each lift must be accompanied by documentation
ð instructions for use ï drawn up in ð a language which can be easily understood by
consumers and other end-users, as determined by the Member State concerned. ï the official language(s)
of the Community, which may be determined in accordance with the Treaty by the
Member State in which the lift is installed. The documentation
ð Those instructions for use ï shall contain at least Ö the
following documents: Õ

ê 95/16/EC

(a)- an instruction manual containing the plans and diagrams necessary
for normal use and relating to maintenance, inspection, repair, periodic checks
and the rescue operations referred to in Section
Point 4.4,;

(b)- a logbook in which
repairs and, where appropriate, periodic checks can be noted.

ê 95/16/EC (adapted)

ANNEX II

A. Content of the Ö EU Õ EC declaration of conformity for safety components Ö for lifts Õ [24]

The Ö EU Õ EC declaration of conformity Öfor safety components for lifts shall be drafted in the same language as the
instruction manual referred to in Annex I, Point 6.1, and be either typewritten or printed and Õ must Ö shall Õ contain the following information:

Ö (a) business Õ - name and Ö full Õ address of the manufacturer of the safety components[25],;

(b)- where appropriate, Ö business Õ name and address of his authorized representative established in
the Community[26]ÖUnion Õ,;

(c)- description of the safety component Ö for lifts Õ, details of
type or series and serial number (if any),;

(d)- safety function of the safety component Ö for lifts Õ, if not
obvious from the description,;

(e)- year of manufacture of the safety component Ö for lifts Õ,;

(f)- all relevant provisions with which the safety component Ö for
lifts Õ complies,;

ò new

(g) a statement
that the safety component for lifts is in conformity with all the relevant
Union harmonisation legislation;

ê 95/16/EC (adapted)

(h)- where appropriate, reference Ö reference(s) Õ to harmonized standard
Ö standard(s) Õ used,;

(i)- where appropriate, Ö the Õ name, address
and identification number of the notified body which carried out the Ö EU Õ EC
type-examination in accordance with Article 15(a) and (b) 8 (1)(a)(i) and (ii), Ö and Õ where appropriate,
the reference to
Ö of Õ the Ö EU Õ EC
type-examination certificate issued by that notified body,;

(j)- where appropriate, name, address and identification number of the
notified body which carried out the production checks in accordance with Article
8(1)
(a) (ii) Ö conformity assessment procedure in accordance with Article 15(a) Õ,;

(k)- where appropriate, name, address and identification number of the
notified body which checked Ö approved Õ the
system of
quality assurance Ö system
operated Õ implemented
by the manufacturer in accordance with Article 15(b) and (c); 8(1) (a) (iii),

identification of the signatory empowered to act
on behalf of the manufacturer of the safety components or his authorized
representative established in the Community.

Ö(l) the name
and function of the person empowered to sign the declaration on behalf of the
manufacturer or his authorized representative established in the Union; Õ

ò new

(m) place and
date of signature;

(n) signature.

ê 95/16/EC (adapted)

B. Content of the EC Ö EU Õ declaration of conformity for installed lifts[27]

The EC Ö EU Õ declaration
of conformity Ö for
lifts shall be drafted in the
same language as the instruction manual referred to in Annex I, Point 6.2, and
be either typewritten or printed and Õ must Ö shall Õ contain
the following information:

Ö (a) business Õ name and Ö full Õ address of the installer of the lift[28],;

(b)- description of the lift, details of the type or series, serial
number and address where the lift is fitted
Ö installed Õ,;

ê 95/16/EC

(c)- year of installation of the lift,;

(d)- all relevant provisions to which the lift conforms,;

ò new

(e) a
statement that the lift is in conformity with all the relevant Union harmonisation
legislation;

ê 95/16/EC (adapted)

ð new

(f)- where appropriate, Ö the Õ reference
Ö reference(s) Õ to harmonized
standards used,;

(g)- where appropriate, Ö the Õ name, address and identification number of the notified
body which carried out the EC Ö EU Õ type-examination of the model of the lift in accordance
with Article 16(1) (a) 8
(2), (i) and (ii), Ö and
the Õ - where appropriate,
reference of the EC
Ö EU Õ type-examination
certificate, Ö issued by
that notified body; Õ

(h)- where appropriate, Ö the Õ name, address
and identification number of the notified body which carried out the Ö unit Õ verification Ö procedure Õ of
the lift in
accordance with Article 8 (2) (iv), 16(1)(c),;

(i)- where appropriate, Ö the Õ name, address and identification number of the notified
body which carried out the final inspection of the lift in accordance with the first indent of
Article 8 (2), (i), (ii) and (iii), 16(1)(a)(i) and 16(1)(b)(i);

(j)- where appropriate, name, address, and identification number of the
notified body which inspected ð approved ï the quality assurance system implemented Ö operated Õ by the
installer in accordance with the second and third indents of
Article (8) (2) (i),
(ii), (iii) and (v) 16(1)(a)(ii); 16(1)(a)(iii);
16(1)(b)(ii); 16(1)(b)(iii) and 16(1)(d),;

–
identification of the signatory having been empowered to act on behalf of
the lift installer.

Ö(k) the name and function of the person empowered to sign
the declaration on behalf of the installer; Õ

ò new

(l) place
and date of signature;

(m) signature.

ê 95/16/EC

ANNEX
III

CE
CONFORMITY MARKING

The CE
conformity marking shall consist of the initials «CE» taking the following
form:

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

The
various components of the CE marking must have substantially the same vertical
dimension, which may not be less than 5 mm. This minimum dimension may
be waived for small-scale safety components.

The CE
marking shall be followed by the identification number of the notified body
that deals with

–
the
procedures referred to in Article 8 (1) (a) (ii) or (iii),

–
the
procedures referred to in Article 8 (2).

ê 95/16/EC (adapted)

ANNEX IIIIV

LIST OF SAFETY
COMPONENTS Ö FOR LIFTS Õ REFERRED TO IN ARTICLE 1 (1) AND ARTICLE 8(1)15

ê 95/16/EC

1. Devices for locking
landing doors.

ê 95/16/EC
(adapted)

2. Devices to prevent
falls referred to in Section Point 3.2 of Annex I to prevent the car
from falling or unchecked
upward Ö uncontrolled Õ movements.

ê 95/16/EC

3. Overspeed limitation
devices.

ê 95/16/EC
(adapted)

4. (a)
Energy-accumulating shock
absorbers Ö buffers Õ :

(i)- either non-linear, Ö or Õ

(ii)- or with damping of the
return movement.

(b) Energy-dissipating shock absorbers
Ö buffers Õ .

ê 95/16/EC

5. Safety devices
fitted to jacks of hydraulic power circuits where these are used as devices to
prevent falls.

ê 95/16/EC
(adapted)

6. Electric safety devices
in the form of safety switches Ö circuits Õ containing electronic components.

ê 95/16/EC (adapted)

ð new

ANNEX IVV

EC Ö EU Õ TYPE-EXAMINATION Ö FOR LIFTS AND SAFETY COMPONENTS FOR LIFTS Õ

(module B)

A. EC Ö EU Õ type-examination
of safety components Ö for lifts Õ

1. EC
Ö EU Õ type-examination
is the ð part of a conformity assessment ï procedure whereby a notified body ascertains and certifies that a
representative specimen of a safety component Ö for lifts Õ will permit
the lift to which it is correctly fitted to satisfy the applicable requirements
of the Directive.

2. The application for Ö EU Õ EC
type-examination shall be lodged by the manufacturer, of the safety component,
or his authorized representative established in the Community
Ö Union, Õ with a ð single ï notified body of his choice.

The application must Ö shall Õ include:

(a) -        the name and address of the manufacturer of
the safety component and of his authorized representative, if the
application is made by the latter,, Ö if the
application is lodged by the authorized representative, his name and
address as well Õ and the place
of manufacture of the safety components Ö for lifts Õ,;

ê 95/16/EC

(b) -       a written declaration that the same
application has not been lodged with any other notified body,;

ê 95/16/EC
(adapted)

(c) -        a technical dossier, Ö file(s); Õ

(d) -       a representative specimen of the safety
component Ö for lifts Õ or
details of the place where it can be examined. The notified body may make reasoned request for further specimens Ö if needed for carrying out the test program Õ.;

ò new

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

ê 95/16/EC (adapted)

3. The technical dossier Ö file Õ must Ö shall Õ allow an assessment of the conformity and adequacy of the
safety component Ö for lifts Õ to
enable a lift to which it is correctly fitted to conform with the
provisions Ö to the applicable requirements Õ of the Directive.

In so far as
is necessary for the purpose of assessing conformity, Tthe technical dossier Ö file Õ should include the following:

(a)- a general description of
the safety component Ö for lifts Õ, including its
area of use (in particular possible limits on speed, load and power) and
conditions (in particular explosive environments and exposure to the elements)
,;

ê 95/16/EC

(b)- design and manufacturing drawings or diagrams,;

ò new

(c) explanations
necessary for the understanding of those drawings and diagrams and the
operation of the safety component for lifts;

ê 95/16/EC (adapted)

Ö (d) a list of the essential health and safety
requirements; Õessential requirement(s) taken into consideration
and the means adopted to satisfy it (them) (e.g. a harmonized standard),

ò new

(e) a list of the harmonised standards the
references of which have been published in the Official Journal of the
European Union, applied in full or in part, and descriptions of the
solutions adopted to meet the essential health and safety requirements of the
Directive where those harmonised standards have not been applied. In the event
of partly applied harmonised standards, the technical file shall specify the
parts which have been applied;

ê 95/16/EC (adapted)

(f)- results of any tests or calculations performed Ö by Õ or subcontracted by
Ö for Õ the
manufacturer,;

ò new

(g) test reports;

ê 95/16/EC (adapted)

(h)- a copy of the assembly instruction Ö manual Õ for the safety components Ö for lifts Õ,;

(i)- steps taken at the manufacturing stage to ensure that
series-produced safety components Ö for lifts Õ conform to the safety component Ö for lifts Õ examined.

4. The notified body
shall:

examine the technical dossier to assess how far it
can meet the desired aims,

Ö (a) examine the technical file to assess the adequacy of the
technical design of the safety component for lifts; Õ

ò new

(b) agree with
the applicant on a location where the examinations and tests will be carried
out;

ê 95/16/EC
(adapted)

–
examine the safety component to check its adequacy in terms of the
technical dossier,

Ö (c)
verify that the representative specimen(s) has(have) been manufactured in
conformity with the technical file, and identify the elements which have been
designed in accordance with the specifications of harmonised standards, as well
as the elements which have been designed without applying the specifications of
those standards; Õ

–
perform or have performed the appropriate checks and tests necessary to
check whether the solutions adopted by the manufacturer of the safety component
meet the requirements of the Directive allowing the safety component to carry
out its function when correctly fitted on a lift.

Ö (d) carry
out appropriate examinations and tests, or have them carried out, to check
whether, where the manufacturer has chosen to apply the specifications of the
relevant harmonised standards, these have been applied correctly; Õ

Ö (e) carry
out appropriate examinations and tests, or have them carried out, to check
whether, where the specifications of the relevant harmonised standards have not
been applied, the solutions adopted by the manufacturer meet the corresponding
essential health and safety requirements of the Directive. Õ

ò new

The
notified body shall draw up an evaluation report that records the examinations,
verifications and tests carried out and their outcome. 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.

ê 95/16/EC (adapted)

5. If the representative specimen of the safety
component complies with the provisions of the Directive applicable to it, the
notified body must issue an EC type-examination certificate to the applicant.
The certificate must contain the name and address of the manufacturer of the safety component, the
conclusions of the check, any conditions of validity of the certificate and the
particulars necessary to identify the approved type.

The Commission, the Member States and the other
notified bodies may obtain a copy of the certificate and, on a reasoned
request, a copy of the technical dossier and reports of examinations,
calculations and tests carried out. If the notified body refuses to issue an EC
type-examination certificate to the manufacturer, it must state the detailed grounds for refusal. Provision must be
made for an appeal procedure.

Ö 5. If the representative specimen(s) of the safety
component for lifts complies(comply) with the essential health and safety
requirements of the Directive, the notified body shall issue an EU
type-examination certificate to the applicant manufacturer. The certificate
shall contain the name and address of the manufacturer of the safety
component and, where appropriate, of his authorised representative, the conclusions
of the type-examination, any conditions of validity of the certificate and the
particulars necessary to identify the approved type. Õ

ò new

The
certificate may have one or more annexes attached.

Where
the representative specimen(s) does(do) not comply with the applicable
essential health and safety requirements of the Directive, the notified body
shall refuse to issue an EU type-examination certificate and shall inform the
applicant accordingly, giving detailed reasons for its refusal.

The
notified body shall keep a copy of the EU type-examination certificate, its
annexes and additions, as well as the technical file and the evaluation report,
for a period of 15 years from the date of issue of the certificate.

ê 95/16/EC
(adapted)

Ö 6. 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 the
Directive, and shall determine whether such changes require further
investigation. If so, the notified body shall inform the manufacturer
accordingly. Õ

6. The manufacturer of the safety component or his
authorized representative established in the Community must inform the
notified body of any alterations, even of a minor nature, which he has made or
plans to make to the approved safety component, including new extensions or
variants not specified in the original technical dossier (see the first indent of Section 3). The notified body must examine the
alterations and inform the applicant whether the EC type-examination
certificate remains valid[29].

Ö 7. The manufacturer or his authorized representative shall
inform the notified body of any modification to the approved type that may
affect the conformity of the safety component for lifts with the essential
health and safety requirements of the Directive or the conditions of validity
of the EU type-examination certificate. Õ

7. Each notified body must communicate to the
Member States the relevant information concerning:

–
EC type-examination certificates issued,

–
EC type-examination certificates withdrawn.

Each notified body must also communicate to the
other notified bodies the relevant information concerning the EC
type-examination certificates it has withdrawn.

Ö The notified body shall examine the modification and inform
the applicant 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. Õ

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

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

Ö 9. The
Commission, the Member States and the other notified bodies may, on request,
obtain a copy of the EU type-examination certificates and additions thereto. On
request, the Commission and the Member States may obtain a copy of the
technical file and of the report on the examinations, verifications and tests
carried out by the notified body. Õ

Ö 10. EU Õ 8. EC type-examination
certificates and the dossiers Ö documents Õ and correspondence relating to Ö EU Õ EC type-examination procedures must Ö shall Õ be drawn up in an official language of the
Member State where the notified body is established or in a language acceptable
to it.

ê 95/16/EC
(adapted)

ð new

9. 11. The
manufacturer of the
safety component or his authorized representative must Ö shall Õ keep with the technical documentation Ö file Õ copies of Ö EU Õ EC type-examination certificates ð , their
annexes ï and their additions for a period of
10 years after the last safety component Ö for lifts Õ has been Ö placed on the market Õ manufactured.

Where neither the
manufacturer of a
safety component nor his authorized representative is
established in the Community
Ö Union, Õ the obligation to keep the technical documentation
Ö file Õ available falls to the person who places the
safety component Ö for lifts Õ on the Community Ö Union Õ market.

ê 95/16/EC
(adapted)

ð new

B. Ö EU Õ EC type-examination of lifts

1. Ö EU Õ EC type-examination is the ð part of a
conformity assessment ï procedure whereby Ö in which Õ a notified body ascertains and certifies that a model lift
or that a lift for which there is no provision for an extension or
variant, satisfies the Ö applicable Õ requirements of the Directive.

2. The application for Ö EU Õ EC type-examination must Ö shall Õ be lodged by the installer of the lift
with a Ösingle Õ notified body of his choice.

The application must Ö shall Õ include:

(a)- the name and address of the installer of the lift,;

ê 95/16/EC

(b)- a written declaration that the same
application has not been lodged with any other notified body,;

ê 95/16/EC
(adapted)

(c)- a technical dossier, Ö file(s); Õ

(d)- details of the place where the model lift
can be examined. The model lift submitted for examination shall include the
terminal parts and be capable of serving at least three levels (top, middle and
bottom),;

ò new

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

ê 95/16/EC (adapted)

3. The technical dossier Ö file Õ must Ö shall Õ allow
an assessment of the conformity of the lift with the provisions Ö essential
health and safety requirements Õ of the Directive and an
understanding of the design and operation of the lift.

In so far as is necessary for the purpose of
assessing conformity, Tthe technical dossier Ö file Õ should include the
following:

(a)- a general description of the representative model of the lift. The technical dossier should indicate Ö indicating Õ clearly all Ö the permitted variations of the Õ possible extensions to the representative model lift under examination (see
Article 1 (4)), Ö referred to in Article 2(3); Õ

ê 95/16/EC

(b)- design and manufacturing drawings or
diagrams,;

ò new

(c) explanations
necessary for the understanding of those drawings and diagrams and of the operation
of the model lift;

ê 95/16/EC (adapted)

Ö (d) a list of the Õ essential Ö health and safety Õ requirements taken into consideration and the means adopted to
satisfy them (e.g. a harmonised standard).;

ò new

(e) a list of the
harmonised standards the references of which have been published in the Official
Journal of the European Union, applied in full or in part, and descriptions
of the solutions adopted to meet the essential health and safety requirements
of the Directive where those harmonised standards have not been applied. In the
event of partly applied harmonised standards, the technical file shall specify
the parts which have been applied;

ê 95/16/EC (adapted)

(f)- a copy of the Ö EU Õ EC
declarations of conformity of the safety components Ö for lifts Õ used in the manufacture of the Ö model Õ lift,;

(g)- results of any tests or calculations performed or subcontracted by
the manufacturer Ö by or for
the installer Õ,;

ò new

(h) test reports;

ê 95/16/EC

(i)- a copy of the lift instruction manual,;

ê 95/16/EC
(adapted)

(j)- steps taken at the installation stage to
ensure that the series-produced lift conforms to the provisions Ö essential health and safety requirements Õ of the Directive.

4. The notified body must Ö shall: Õ

(a)- examine the technical dossier Ö file Õ to assess how far it
can meet the desired aims, Ö the adequacy of the
technical design of the model lift; Õ

ò new

(b) agree with the installer on a location where the examinations and
tests will be carried out;

ê 95/16/EC
(adapted)

–
examine the representative model of the lift to
check that it has been manufactured in accordance with the technical
dossier,

ò new

(c) examine the model lift to check that
it has been manufactured in accordance with the technical file, and identify
the elements which have been designed in accordance with the specifications of
the relevant harmonised standards, as well as the elements which have been
designed without applying the specifications of those standards;

ê 95/16/EC
(adapted)

–
perform or have performed the appropriate checks and tests necessary to
check that the solutions adopted by the installer of the lift meet the
requirements of the Directive and allow the lift to comply with them.

ò new

(d) carry out appropriate examinations
and tests, or have them carried out, to check whether, where the installer has
chosen to apply the specifications of the relevant harmonised standards, these
have been applied correctly;

(e) carry out appropriate examinations and tests, or
have them carried out, to check whether, where the specifications of the
relevant harmonised standards have not been applied, the solutions adopted by
the installer meet the corresponding essential health and safety requirements
of the Directive.

The notified body shall draw up an
evaluation report that records the examinations, verifications and tests carried
out undertaken and their outcome. 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 lifts
manufacturer

ê 95/16/EC (adapted)

ð new

5. If the model
lift complies with the provisions of the Directive ð essential health and safety
requirements set out in Annex I ï applicable to it, the notified body must
Ö shall Õ issue an EC Ö EU Õ type-examination
certificate to the applicant
Ö installer Õ. The
certificate must Ö shall Õ contain the name and address of the installer, the conclusions of the check,
Ö the EU type-examination Õ, any conditions of validity of the certificate and the particulars
necessary to identify the approved type
Ö model
lift Õ.

If the notified body refuses to issue an EC
type-examination certificate to the manufacturer, it must state the detailed
grounds for refusal. Provision must be made for an appeal procedure.

6. The installer of the lift must inform the
notified body of any alterations, even of a minor nature, which he has made
or plans to make to the approved lift, including new extensions or variants not
specified in the original technical dossier (see the first indent of Section
3). The notified body must examine the alterations and inform the applicant whether the EC type-examination certificate
remains valid[30].

7. Each notified body must communicate to the
Member States the relevant information concerning:

–
EC type-examination certificates issued,

–
EC type-examination certificates withdrawn.

Each notified body must also communicate to the
other notified bodies the relevant information concerning the EC
type-examination certificates it has withdrawn.

ò new

The certificate may have one or more
annexes attached.

Where the model lift does not comply with
the essential health and safety requirements set out in Annex I, the notified
body shall refuse to issue an EU type-examination certificate and shall inform
the installer accordingly, giving detailed reasons for its refusal.

The notified body shall keep a copy of
the EU type-examination certificate, its annexes and additions, as well as the technical
file and the evaluation report for a period of 15 years from the date of issue of the
certificate.

6. 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 essential health and
safety requirements set out in Annex I and shall determine whether such changes
require further investigation. If so, the notified body shall inform the
installer accordingly.

7. The installer shall inform the
notified body of any modifications to the approved type, including variations
not specified in the original technical file, that may affect the conformity of
the lift with the essential health and
safety requirements set out in Annex I or the conditions of validity of the
certificate.

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

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

ê 95/16/EC
(adapted)

9. The
Commission, the Member States and the other notified bodies may Ö, on
request, Õ obtain a copy
of the EC Ö EU type-examination
certificates and additions thereto Õ certificate and, on a
reasoned request,. Ö On
request, the Commission and the Member States may obtain Õ a copy of the
technical Ö file Õ dossier
and Ö of the
report on the examinations, verifications and tests carried out by the notified
body. Õ and reports of examinations,
calculations and tests carried out.

8.10. EC Ö EU Õ
type-examination certificates and the dossiers
Ö documents Õ and
correspondence relating to ECÖ EU Õ type-examination
procedures must Ö shall Õ be drawn up in
one Ö an Õ of the official
languages Ö language Õ of the Member
State where the notified body is established or in a language acceptable to it.

ê 95/16/EC
(adapted)

ð new

9.11. The installer of the lift must Ö shall Õ keep with the technical documentation
Ö file Õ copies
of EC Ö EU Õ type-examination certificates ð , their
annexes ï and
their additions for a period of at least 10 years after the last
lift has been manufactured Ö placed
on the market Õ in conformity with the representative model of the lift.

ê 95/16/EC (adapted)

ANNEX VVI

FINAL
INSPECTION Ö FOR LIFTS Õ

1. Final inspection is the procedure whereby the
installer of the lift who fulfils the obligations of Section 2 ensures and
declares that the lift which is being placed on the market satisfies the
requirements of the Directive. The installer of the lift shall affix the CE
marking in the car of each lift and draw up an EC declaration of conformity.

Ö 1. Final inspection is the part of a conformity
assessment procedure whereby a notified body ascertains and certifies that an
installed lift subject to an EU type-examination certificate or designed and
manufactured according to an approved full quality assurance system satisfies
the essential health and safety requirements set out in Annex I. Õ

2. The installer of the lift shall take all steps
necessary to ensure that the lift being placed on the market conforms with the
model lift described in the EC type-examination certificate and the
essential health and safety requirements applicable to it.

Ö 2. Obligations of the installer Õ

Ö 2.1. The installer shall take all measures
necessary to ensure that the lift being installed complies with the essential health and safety requirements set
out in Annex I and with any of the
following: Õ

Ö (a)  an
approved type described in an EU type-examination certificate; Õ

Ö (b)  a
lift designed and manufactured in accordance with a full quality assurance
system pursuant to Annex XI and the EU design examination certificate if the design
is not wholly in accordance with the harmonized standards. Õ

ê 95/16/EC
(adapted)

Ö2.2. The installer shall draw up an EU declaration of conformity and affix the CE marking in the
car of each lift which satisfies the essential health and safety requirements
of this Directive. Õ

Ö 3. Final inspection. Õ

5. The notified body must receive the following
documents:

Ö 3.1 The installer shall provide to the notified
body the following documents: Õ

(a)- the plan of the complete lift,;

(b)- the plans and diagrams necessary for final inspection, in particular
control circuit diagrams,;

(c)- a copy of the instruction manual Ö for use Õ referred to in
Annex I, Section Point
6.2.

The notified body may not require detailed
plans or precise information not necessary for verifying the conformity of the Ö installed Õ lift about to be placed on the market with the model lift described in the EC
type-examination declaration.

Ö 3.2 A notified body chosen by the installer shall carry out
the final inspection of the installed lift about to be placed on the market in
order to check the conformity of the lift with
the applicable essential health and safety requirements of this
Directive. Õ

Ö The
appropriate examinations and tests set out in the relevant harmonised
standard(s) referred to in Article 14 shall be carried out in order to ensure
the conformity of the lift with the applicable essential health and safety
requirements of this Directive. In the absence of such harmonised standards,
the notified body concerned shall determine the appropriate equivalent tests to
be carried out. Õ

4. A notified body chosen by the installer of the
lift shall carry out or have carried out the final inspection of the lift about
to be placed on the market. The appropriate tests and checks defined by the
applicable standard(s) referred to in Article 5, or equivalent tests, must be
carried out in order to ensure conformity of
the lift with the relevant requirements of the Directive.

These checks and tests shall cover in particular:

(a)          examination of the documentation
to check that the lift conforms with the representative model of the lift
approved in accordance with Annex V.B;

Ö 3.3. The examinations shall include at least any
of the following: Õ

Ö (a) examination of the documents referred to in point 3.1 to check that
the installed lift conforms with the model lift subject to an EU type-examination certificate
pursuant to Annex IV B; Õ

ò new

(b) examination
of the documents referred in point 3.1 to check that the installed lift
conforms with the lift designed and manufactured in accordance with an approved
full quality assurance system pursuant to Annex XI and if the design is not
wholly in accordance with the harmonized standards, with the EU design
examination certificate.

ê 95/16/EC (adapted)

Ö 3.4. The tests shall include at least any of the following: Õ

ê 95/16/EC

(a)- operation of the lift both empty and at maximum load to ensure
correct installation and operation of the safety devices (end stops, locking
devices, etc.),;

(b)- operation of the lift at both maximum load
and empty to ensure the correct functioning of the safety devices in the event
of loss of power,;

ê 95/16/EC
(adapted)

(c)- static test with a load equal to 1,25 times
the nominal Ö rated Õ load.

The nominal Ö rated Õ load shall be that referred to in Annex I, Section Point 5.

ê 95/16/EC

After these tests, the notified body shall check that no
distortion or deterioration which could impair the use of the lift has
occurred.

ê 95/16/EC
(adapted)

Ö 4. If the installed lift satisfies the essential
health and safety requirements set out in Annex I, the notified body shall
affix or have affixed its identification number adjacent to the CE marking in
accordance with Articles 18 and 19 and shall draw up a final inspection
certificate which mentions the examinations and tests carried out. Õ

6. If the lift satisfies the provisions of the
Directive, the notified body shall affix or have affixed its identification
number adjacent to the CE marking in accordance with Annex III and shall draw
up a final inspection certificate which mentions the checks and tests carried
out.

ê 95/16/EC

The notified body shall fill in the corresponding pages in
the logbook referred to in Annex I, Section Point
6.2.

ê 95/16/EC
(adapted)

If the notified body refuses to issue the final inspection
certificate, it must Ö shall Õ state the detailed reasons for refusal recommend
means whereby acceptance may be obtained. Ö and indicate the necessary corrective measures
to be taken. Õ Where
the installer again applies for final inspection, he must Ö shall Õ apply to the same notified body.

7. The final inspection certificate, dossiers and
correspondence relating to the acceptance procedures shall be drawn up in one
of the official languages of the Member State where the notified body is
established or in a language acceptable to it.

Ö 5. The final inspection certificate, documentation and
correspondence relating to the final inspection acceptance procedures shall be
drawn up in one of the official languages of the Member State where the
notified body is established or in a language acceptable to it. Õ

6. 3. The installer of the lift shall keep a copy of the EC Ö EU Õ declaration of conformity and the final inspection
certificate referred to in Section 6 for 10 years after Ö the placing Õ from the date when the
lift was placed on
the market Ö of the lift Õ .

ò new

7. The Commission and the Member states
may obtain a copy of the final inspection certificate on request.

ê 95/16/EC (adapted)

ANNEX VII

MINIMUM CRITERIA TO BE
TAKEN INTO ACCOUNT BY MEMBER STATES FOR THE NOTIFICATION OF BODIES

1. The body, its director and the staff responsible
for carrying out verification operations may not be the designer, builder,
supplier or manufacturer of safety components or installer of the lifts which
they inspect, nor the authorized representative of any of these parties.
Similarly, the body, its director and the
staff responsible for supervising the quality assurance systems referred to in
Article 8 of the Directive may not be the designer, builder, supplier or
manufacturer of safety components or installer of the lifts which they inspect,
nor the authorized representative of any of these parties. They may not
become involved either directly or as authorized representatives in the design,
construction, marketing or maintenance of the safety components or in the
installation of lifts. This does not
preclude the possibility of exchanges of technical information between the
manufacturer of the safety components or the installer of the lift and the
body.

2. The body and its staff must carry out the
inspection or supervision operations with the highest degree of professional
integrity and technical competence and must be free from all pressures and
inducements, particularly financial, which might influence their judgment or
the results of the inspection, especially from persons or groups of persons with an interest in the result of inspection or
supervision.

3. The body must have at its disposal the
necessary staff and possess the necessary facilities to enable it to perform
properly the technical and administrative tasks connected with inspection or supervision;
it must also have access to the equipment required for special verification.

4. The staff responsible for inspection must have:

sound technical and professional training, satisfactory knowledge
of the requirements for the tests they carry out and adequate experience of
such tests, the ability to draw up the certificates, records and reports required to
authenticate the performance of the tests.

5. The impartiality of the inspection staff must
be guaranteed. Their remuneration must not depend on the number of tests
carried out or on the results of such tests.

6. The body must take out liability insurance
unless its liability is assumed by the State in accordance with national law,
or the Member State itself is directly responsible for the tests.

7. The staff of the body must observe professional
secrecy with regard to all information gained in carrying out its tasks (except
vis-à-vis the competent administrative authorities of the State in which its
activities are carried out) under this Directive or any provision of
national law giving effect to it.

ê 95/16/EC (adapted)

ð new

ANNEX
VI VIII

PRODUCT QUALITY
ASSURANCE Ö FOR SAFETY COMPONENTS FOR LIFTS Õ

(module E)

Product quality assurance is the procedure
whereby the manufacturer of the safety component who satisfies Section 2
ensures and declares that the safety components are in conformity with the type
as described in the EC type-examination certificate and satisfy the
requirements of the Directive that apply to
them and ensures and declares that the safety component will enable a lift to
which it is correctly fitted to satisfy the provisions of the Directive.

The manufacturer of the safety component or his
authorized representative established in the Community must affix the CE
marking to each safety component and draw up an EC declaration of conformity.
The CE marking must be accompanied by the identification number of the notified
body responsible for surveillance as specified in Section 4.

2. The manufacturer must apply an approved quality
assurance system for final inspection of the safety component and testing as
specified in Section 3, and must be subject to surveillance as specified in
Section 4.

Ö 1. Product quality assurance for safety
components for lifts is the part of the conformity assessment procedure whereby
a notified body assesses the product quality assurance system of a manufacturer
in order to ensure that the safety components for lifts are manufactured and monitored
in conformity with the type described in the EU type-examination certificate
and satisfy the essential health and safety requirements set out in Annex I and
will enable a lift to which they are correctly fitted to satisfy those
requirements. Õ

Ö 2. Obligations of the manufacturer Õ

Ö 2.1. The manufacturer shall apply an approved
product quality assurance system for final inspection and testing of the safety
component for lifts as specified in Point 3, and shall be subject to
surveillance as specified in Point 4. Õ

Ö 2.2. The manufacturer or his authorized
representative established in the Union shall affix the CE marking to each
safety component for lifts and draw up an EU declaration of conformity. Õ

3. Ö Product Õ Qquality assurance system

3.1. The manufacturer of the safety components Ö or his authorised representative Õ must Ö shall Õ lodge an application for assessment of his Ö the product Õ quality assurance system for the safety components concerned Ö for lifts Õ with a ð single ï notified body of his choice.

The application must
include:

ò new

(a)
the name and address of the manufacturer and, if the application is lodged by
his 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 premises where final inspection and testing of the safety components for
lifts are carried out;

ê 95/16/EC (adapted)

(d)- all relevant information for Ö on Õ the safety components envisaged Ö for lifts to be manufactured Õ,;

(e)- the documentation on the Ö product Õ quality assurance system,;

(f)- the technical documentation Ö file(s) Õ of the approved
safety components Ö for lifts
to be manufactured Õ and a copy of
the EC
Ö EU Õ type-examination certificates. Ö certificate(s). Õ

3.2. Under the Ö product Õ quality assurance system, each safety component
Ö for lifts shall Õ must be examined Ö inspected Õ and appropriate tests as set out in the relevant standards
referred to in Article 514 or
equivalent tests Öshall Õ must be carried out in order to
ensure its conformity to the relevant requirements of the Directive. Ö essential
health and safety requirements set out in Annex I. Õ

All the elements,
requirements and provisions adopted by the manufacturer of the safety components must Ö shall Õ be documented in a systematic and orderly
manner in the form of written measures, procedures and instructions. This
quality assurance system documentation must Ö shall Õ ensure a common understanding of the quality
programmes, plans, manuals and records.

ê 95/16/EC

It must contain in particular
an adequate description of:

(a)          the quality
objectives;

ê 95/16/EC (adapted)

(b)          the
organizational structure, responsibilities and powers of the management with
regard to quality of the safety component Ö for lifts Õ;

(c)          the examinations
Ö inspections Õ and tests that will be carried out after manufacture;

(d)          the means to
verify the effective operation of the Ö product Õ quality assurance system;

ê 95/16/EC

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

ê 95/16/EC (adapted)

3.3. The notified body
must assess the Ö product Õ quality assurance system to determine whether
it satisfies the requirements referred to in Section Point 3.2. It Ö shall Õ must presume conformity with
these requirements in respect of Ö product Õ quality assurance systems that implement the
relevant harmonized standard[31].

The auditing team must
have at least one member with experience of assessment in the lift technology
concerned Ö and knowledge of the essential health and
safety requirements set out in Annex I. Õ

The assessment
procedure must
Ö shall Õ include a visit to the premises of the safety
component manufacturer Ö where final inspection and testing of safety
components for lifts are
carried out Õ.

ê 95/16/EC
(adapted)

The decision must be notified to the manufacturer
of the safety components. The notification must contain the conclusions of the
examination and the reasoned assessment decision.

Ö The
decision shall be notified to the manufacturer. The notification shall contain
the conclusions of the examination and the reasoned assessment report. Õ

ò new

Under the responsibility of the notified
body, the manufacturer shall affix the identification number of the notified
body adjacent to the CE marking in accordance with Articles 18 and 19 to the
safety components for lifts during the manufacturing process.

ê 95/16/EC (adapted)

3.4. The manufacturer of the safety components
must
Ö shall Õ undertake to discharge the obligations arising
from the Ö product Õ quality assurance system as approved and to
ensure that it is maintained in an appropriate and efficient manner.

The manufacturer of the safety components
or his authorized representative established in the Community Ö Union Õ must Ö shall Õ keep the notified body which has approved the Ö product Õ quality assurance system informed of any
intended updating of the quality assurance system.

The notified body must Ö shall Õ assess the modifications proposed and decide
whether the modified Ö product Õ quality assurance system still satisfies the
requirements referred to in Section Point 3.2 or whether a reassessment is
required.

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

4. Surveillance under the responsibility of the notified body

4.1. The purpose of
surveillance is to make sure that the manufacturer of the safety component duly
fulfils the obligations arising out of the approved Ö product Õ quality assurance system.

4.2. The manufacturer must Ö shall Õ allow the notified body access for inspection
purposes to the Ö premises
where final Õ inspection,
testing and storage locations
Ö are
carried out Õ and provide it
with all necessary information, in particular:

(a)- the Ö product Õ quality assurance system documentation,;

(b)- the technical Ö file(s); Õ documentation,

ê 95/16/EC

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

ê 95/16/EC (adapted)

ð new

4.3. The notified body must Ö shall Õ periodically carry out audits to ensure that
the manufacturer of
the safety components maintains and applies the Ö product Õ quality assurance system and must Ö shall Õ provide an audit report to the manufacturer of the safety components, ðand, where appropriate, to his
authorised representative. ï

4.4. Additionally, the
notified body may pay unexpected visits to the manufacturer of the safety component
Ö premises where final inspection and
testing of safety components for lifts are carried out Õ.

At the time of such
visits, the notified body may, where necessary, carry out tests or have them carried out in order to check
the proper functioning of the Ö product Õ quality assurance system where necessary;. it must Ö It
shall Õ provide the
manufacturer of the
safety components ðand, where appropriate, to his
authorised representative, ï with a visit report
and, if a test has been carried out, with a test report.

5. The manufacturer must Ö shall Õ for a period ending 10 years after the last
safety component Ö for lifts Õ has been manufactured ð placed on
the market ï, keep at the disposal of the national
authorities:

ê 95/16/EC (adapted)

(a)- the documentation Ö technical file(s) Õ referred to in the third indent of the second paragraph of
Section
Point 3.1(f),;

ò new

(b)
the documentation referred to in Point 3.1(e);

ê 95/16/EC
(adapted)

(c)- the updating referred to in the second
paragraph of Section Point
3.4,;

(d)- the decisions and
reports from the notified body which are referred to in the final paragraph of Section Point 3.4
and in Sections Points
4.3 and 4.4.

6. Each
notified body must forward to the other notified bodies the relevant
information concerning the quality assurance system approvals issued and
withdrawn.

ò new

6. Each notified body shall inform its
notifying authorities of product quality assurance system approval decision(s)
issued or withdrawn, and shall, periodically or upon request, make available to
its notifying authorities the list of approval decisions, issued, refused,
suspended or otherwise restricted.

Each notified body shall inform the other
notified bodies of product quality assurance system approval decision(s) which
it has refused, suspended or withdrawn and, upon request, of approval decision(s)
which it has issued.

On request, the notified body shall
provide the Commission and the Member States with a copy of product quality
assurance system approval decision(s) issued.

7. The documents and correspondence
relating to the product quality assurance system shall be drawn up in one of
the official languages of the Member State where the notified body is
established or in a language acceptable to it.

ê 95/16/EC (adapted)

ANNEX VII IX

FULL QUALITY
ASSURANCE Ö FOR SAFETY COMPONENTS FOR LIFTS Õ

(module H)

1. Full quality assurance is the procedure whereby
the manufacturer of the safety component who satisfies the obligations of
Section 2 ensures and declares that the safety components satisfy the
requirements of the Directive that apply to them and that the safety component
will enable a lift to which it is correctly fitted to satisfy the requirements
of the Directive.

The manufacturer or his authorized
representative established in the Community must affix the CE marking to each
safety component and draw up an EC declaration of conformity. The CE marking
must be accompanied by the identification number of the notified body responsible for the surveillance as specified
in Section 4.

2. The manufacturer must operate an approved
quality assurance system for design, manufacture and final inspection of the
safety components and testing as specified in Section 3 and must be subject
to surveillance as specified in Section 4.

Ö 1. Full quality assurance for safety components
for lifts is the conformity assessment procedure whereby a notified body
assesses the full quality assurance system of a manufacturer to ensure that the
safety components for lifts are designed, manufactured, inspected and tested
in order to satisfy the essential health and safety requirements set out in
Annex I and to enable a lift to which they are correctly fitted to satisfy
those requirements. Õ

Ö 2.1. The manufacturer shall operate an approved
full quality assurance system for the design, manufacture, final inspection and
testing of safety components for lifts as specified in Point 3 and shall be
subject to surveillance as specified in Point 4. Õ

Ö 2.2. The
manufacturer or his authorized representative established in the Union shall
affix the CE marking to each safety component for lifts and draw up an EU
declaration of conformity. The CE marking shall be accompanied by the
identification number of the notified body responsible for the surveillance as
specified in Point 4. Õ

3. Ö FULL Õ Qquality
assurance system

ê 95/16/EC
(adapted)

ð new

3.1. The manufacturer must Ö or
his authorised representative shall Õ lodge
an application for assessment of his Ö full Õ quality assurance system with a ð single ï notified body Ö of
his choice Õ. The application must Ö shall Õ include:

ò new

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

(b) the
premises where the safety components for lifts are designed, manufactured,
inspected and tested;

ê 95/16/EC (adapted)

(c)- all relevant information on safety components Ö for lifts to be manufactured Õ,;

ò new

(d) a
technical file according to Annex IVA Point 3 for one model of each category of
safety component for lifts according to Annex III to be manufactured;

ê 95/16/EC (adapted)

(e) the documentation on the Ö full Õ quality assurance system,;

ò new

(f) a
written declaration that the same application has not been lodged with any
other notified body.

ê 95/16/EC (adapted)

3.2. The quality assurance system must ensure
compliance of the safety components with the requirements of the Directive that
apply to them and enable lifts to which they have been correctly fitted to
satisfy those requirements.

3.2.
All the elements, requirements and provisions adopted by the manufacturer must Ö shall Õ be documented in a systematic and orderly
manner in the form of written measures, procedures and instructions. This Ö full Õ quality assurance system documentation must Ö shall Õ ensure a common understanding of the quality
policies and procedures such as quality programmes, plans, manuals and records.

It must Ö shall Õ contain in particular an adequate description
of:

(a)- the quality objectives and the organizational structure,
responsibilities and powers of the management with regard to the design and
quality of the safety components Ö for lifts Õ,;

(b)- the technical design specifications, including standards, that will
be applied and, where the standards referred to in Article 514 Ö are
not Õwill not be
applied Ö or not applied Õ in full, the means that will be used to ensure that the essential Ö health
and safety Õ requirements of
the Directive that apply to the safety components Ö set out in Annex I Õ will be met,;

(c)- the design control and design verification techniques, processes
and systematic actions that will be used when designing the safety components Ö for lifts Õ,;

ê 95/16/EC

(d)- the corresponding manufacturing, quality control and quality
assurance techniques, processes and systematic actions that will be used,;

(e)- the examinations and tests that will 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, reports on the qualifications of 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 assurance system.

ê 95/16/EC (adapted)

ð new

3.3. The notified body must
Ö shall Õ assess the Ö full Õ quality assurance system to determine whether it satisfies the requirements
referred to in Section Point 3.2.
It must Ö shall Õ presume compliance with these requirements in respect of quality
assurance systems that implement the relevant harmonized standard[32].

The auditing team must Ö shall Õ have at least one member with experience of
assessment in the lift technology concerned ð and knowledge of the essential
health and safety requirements set out in Annex I. ï The assessment procedure must include a
visit to the manufacturer's premises.

ò new

The
auditing team shall review the technical file(s) referred to in Point 3.1 to
verify the manufacturer's ability to identify the essential health and safety
requirements set out in Annex I and to carry out the necessary examinations
with a view to ensuring compliance of the safety components for lifts with
those requirements.

ê 95/16/EC (adapted)

ð new

The decision must Ö shall Õ be notified to the manufacturer of the safety components
ð and, where appropriate,
to his authorised representative. ï The notification must Ö shall Õ contain the conclusions of the Ö assessment Õ examination and the reasoned assessment Ö approval Õ decision.

ò new

Under
the responsibility of the notified body, the manufacturer shall affix the
identification number of the notified body adjacent to the CE marking in
accordance with Articles 18 and 19 to the safety components for lifts during
the manufacturing process.

ê 95/16/EC (adapted)

3.4. The manufacturer of the safety components must
undertake Ö shall undertake Õ to discharge the obligations arising from the Ö full Õ quality assurance system as approved and to
ensure that it is maintained in an appropriate and efficient manner.

The manufacturer or his
authorized representative established in the Community must Ö shall Õ keep the notified body which has approved the Ö full Õ quality assurance system informed of any
intended updating of the quality assurance system.

The notified body must Ö shall Õ assess the modifications proposed and decide
whether the modified Ö full Õ quality assurance system will still satisfy the
requirements referred to in Section Point 3.2 or whether a reassessment is
required.

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

4. Surveillance under the responsibility of the notified body

4.1. The purpose of
surveillance is to make sure that the manufacturer of the safety components
duly fulfils the obligations arising out of the approved Ö full Õ quality assurance system.

4.2. The manufacturer of
the safety components must
Ö shall Õ allow the notified body access for inspection purposes to the
design, manufacture, inspection and testing, and storage locations, and must
Ö shall Õ provide it with all necessary information, in particular:

(a)- the Ö full Õ quality assurance system documentation,;

(b)- the quality records provided for in the design part of the Ö full Õ quality Ö assurance Õ system, such
as results of analyses, calculations, tests, etc.,;

ò new

(c) the technical
files for the safety components for lifts manufactured;

ê 95/16/EC (adapted)

ð new

(d)- the quality records provided for in the manufacturing
part of the Ö full Õ quality assurance system, such as inspection reports and test data,
calibration data, reports on the qualifications of the personnel concerned,
etc.

4.3. The notified body must Ö shall Õ periodically carry out audits to make sure that
the manufacturer of
the safety components maintains and applies the Ö the approved full Õ quality assurance system and must Ö shall Õ provide an audit report to the manufacturer of the
safety components.

4.4. Additionally, the
notified body may pay unexpected visits to the manufacturer of the
safety components.
At the time of such visits, the notified body may, where necessary, carry
out tests or have them carried out in order to check the proper functioning of
the Ö full Õ quality assurance system where necessary; . it must Ö It shall Õ provide the manufacturer of the safety components with a visit report and, if a test has been carried out,
with a test report.

5. The manufacturer of the safety components or his
authorized representative must Ö shall Õ for a period of 10 years after the last safety component Ö for lifts Õ has been
manufactured ð placed on the market, ï keep at the disposal of the national authorities:

ê 95/16/EC
(adapted)

(a)- the documentation referred to in the second indent of the second paragraph of
Section Point 3.1(e),;

ò new

(b)
the technical file referred
to in Point 3.1(d);

ê 95/16/EC

(c)- the updating referred to in the second paragraph of Section Point 3.4,;

ê 95/16/EC
(adapted)

(d)- the decisions and reports from the notified body which
are referred to in the final paragraph of Section Point 3.4
and in Sections Points 4.3
and 4.4.

Where, neither the
manufacturer of the safety components Ö for lifts Õ nor his
authorized representative is established in the Ö Union Õ Community, the obligation to keep the technical
documentation available falls to the person who places the safety component Ö for lifts Õ on the Ö Union Õ Community market.

6. Each notified body must forward to the other
notified bodies the relevant information concerning the quality assurance
system approvals issued and withdrawn.

ò new

6. Each notified
body shall inform its notifying authorities of full quality assurance system
approval decision(s) issued or withdrawn, and shall, periodically or upon
request, make available to its notifying authorities the list of approval
decisions issued, refused, suspended or otherwise restricted.

Each notified
body shall inform the other notified bodies of full quality assurance system
approval decision which it has refused, suspended or withdrawn and, upon
request, of approval decisions which it has issued.

On request, the
notified body shall provide the Commission and the Member States with a copy of
full quality system approval decision(s) issued.

The notified body
shall keep a copy of the approval decision(s) issued, its annexes and
additions, as well as the technical file for a period of 15 years from the date
of their issue.

ê 95/16/EC (adapted)

7. The dossiers
Ö documents Õ and correspondence relating to the full quality assurance
procedures must Ö shall Õ be drawn up in one of the official languages of the Member
State where the notified body is established or in a language acceptable to it.

ê 95/16/EC (adapted)

ð new

ANNEX VIII X

UNIT
VERIFICATION Ö FOR LIFTS Õ

(module G)

1. Unit verification is the procedure whereby the
installer of a lift ensures and declares that a lift which is being placed on
the market and which has obtained the certificate of conformity referred to in
Section 4 complies with the requirements of the Directive. The installer of
the lift must affix the CE marking in the car of the lift and draw up an EC
declaration of conformity.

Ö1. Unit verification is the conformity assessment procedure
whereby a notified body assesses whether an installed lift complies with the
essential health and safety requirements set out in Annex I. Õ

Ö 2. Obligations of the installer Õ

Ö 2.1.The
installer shall affix the CE marking in the car of the lift and draw up an EU declaration
of conformity. Õ

2.2.2. The lift installer shall apply to a ð single ï notified body of his choice for unit
verification.

ê 95/16/EC

The application shall
contain:

ê 95/16/EC (adapted)

(a)- the name and address of the installer, of the lift,;

(b)- and
the location where the lift is
installed,;

ê 95/16/EC

(c)- a written
declaration to the effect that a similar application has not been lodged with
another notified body,;

ê 95/16/EC
(adapted)

(d)- a technical Ö file Õ dossier .

3. The purpose of the
technical dossier is to enable the conformity of the lift with the requirements
of the Directive to be assessed and the design, installation and operation
of the lift to be understood. Ö The
technical file shall allow an assessment of the conformity of the
lift with the essential health and safety requirements set out in Annex I Õ.

ê 95/16/EC
(adapted)

So far as relevant for conformity assessment, tThe technical Ö file Õ dossier shall contain Ö at least Õ the following Ö elements Õ :

(a)- a general description of
the lift,;

(b)- design and manufacturing drawings and diagrams,;

–
the essential requirements in question and the solution adopted to meet
them (e.g. harmonized standard),

ò new

(c) explanations
necessary for the understanding of those drawings and diagrams and of the
operation of the lift;

(d) a
list of the harmonised standards the references of which have been published in
the Official Journal of the European Union, applied in full or in
part, and descriptions of the solutions adopted to meet the essential health
and safety requirements set out in Annex I where those harmonised standards have not been applied. In
the event of partly applied harmonised standards, the technical file shall
specify the parts which have been applied;

ê 95/16/EC (adapted)

(e)- a copy of the Ö EU Õ EC type-examination certificates of the safety components Ö for
lifts Õ used Ö in
the lift Õ,;

(f)- results of any tests or calculations Ö performed
by or for the installer; Õ carried out or subcontracted by the installer of the lift,;

ò new

(g) test
reports;

ê 95/16/EC (adapted)

(h)- a copy of the instructions for use of the
lift Öreferred to in point 6.2 of Annex I Õ .

4. The notified body must Ö shall Õ examine the technical dossier Ö file Õ and the lift and carry out the appropriate tests as set
out in the relevant standard(s) referred to in Article 514 of the Directive, or equivalent
tests, to ensure its conformity with the relevant Ö essential
health and safety Õ requirements of this Directive Ö set out in Annex I. The tests shall include at least the tests referred to in Point 3.4
(e) of Annex V. Õ

If the lift
meets the requirements of this Directive, the notified body shall affix, or
cause to be affixed, its identification number adjacent to the CE marking in
accordance with Annex III and shall draw up a certificate of conformity
relating to the tests carried out.

Ö If the lift meets the essential health and safety requirements
set out in Annex I the notified body shall draw up a certificate of conformity
relating to the tests carried out. The notified body shall affix, or cause to
be affixed, its identification number adjacent to the CE marking in accordance
with Articles 18 and 21. Õ

The notified body shall fill in the
corresponding pages of the logbook referred to in Section Point 6.2
of Annex I.

If the notified body
refuses to issue the certificate of conformity, it must Ö shall Õ state in detail its reasons for refusing Ö refusal Õ and indicate Ö the
necessary corrective measures to be taken Õ how conformity can be achieved. When the installer of the lift
reapplies for Ö unit Õ verification he must Ö shall Õ apply to the same notified body.

ò new

On
request, the notified body shall provide the Commission and the Member states
with a copy of the certificate of conformity.

ê 95/16/EC (adapted)

5. The certificate of
conformity and the dossiers
Ö documents Õ and
correspondence relating to unit verification procedures must Ö shall Õ be drawn up in an official language of the
Member State where the notified body is established or in a language acceptable
to it.

6. The installer of the lift
shall keep with the technical Ö file Õ dossier a copy of the certificate of conformity for a
period of 10 years from the date on which the lift is placed on the market.

ê 95/16/EC (adapted)

ANNEX IX XI

CONFORMITY TO TYPE WITH RANDOM CHECKING

Ö FOR SAFETY COMPONENTS FOR LIFTS Õ

(module Ö F Õ C)

1. Conformity to type is the procedure whereby the
manufacturer of the safety components or his authorized representative
established in the Community ensures and declares that the safety components
are in conformity with the type as described in the EC type certificate and
satisfy the requirements of the Directive that apply to them and enable any
lift to which they are correctly fitted to satisfy the essential health and
safety requirements of the Directive.

Ö 1. Conformity
to type with random checking is the part of the conformity assessment procedure
whereby a notified body carries out checks on safety components for lifts to
ensure that they are in conformity with the type as described in the EU type
certificate and satisfy the applicable essential health
and safety requirements of the Directive and enable a lift to which they are
correctly fitted to satisfy those requirements. Õ

The manufacturer of the safety components, or his
authorized representative established in the Community, must affix the CE
marking to each safety component and draw up an EC declaration of conformity.

2. The manufacturer of the safety components must
take all measures necessary to ensure that the manufacturing process assures
conformity of the manufactured safety components with the type as described in
the EC type-examination certificate and with the requirements of the Directive
that apply to them.

Ö 2. Obligations of the manufacturer Õ

Ö 2.1. The
manufacturer shall take all measures necessary to ensure that the manufacturing
process ensures conformity of the manufactured safety components for lifts with
the type as described in the EU type examination certificate and with the essential health and safety requirements set out in
Annex I. Õ

Ö 2.2. The
manufacturer or his authorized representative established in the Union must
affix the CE marking to each safety component for lifts and draw up an EU
declaration of conformity. Õ

Ö 3.The
manufacturer or his authorised representative shall lodge an application for
random checking with a single notified body of his choice.

The application shall
include: Õ

ò new

(a) the
name and address of the manufacturer and, if the application is lodged by his
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 on the safety components for lifts manufactured;

(d) the
premises where the sample of the safety components for lifts can be taken.

ê 95/16/EC (adapted)

4. A Ö The Õ notified body chosen by the manufacturer must Ö shall Õ carry out or have carried out checks on safety
components Ö for
lifts Õ at random intervals. An adequate sample of the
finished safety components, taken on site by the notified body, must be
examined and appropriate tests as set out in the relevant standard(s) referred
to in Article 514, or equivalent tests, must Ö shall Õ be carried out to check the conformity of
production to the relevant
requirements of the Directive Ö essential health and safety requirements set out in
Annex I Õ . In those cases where one or more of the safety components Ö for
lifts Õ checked
do not conform, the notified body must Ö shall Õ take appropriate measures.

The points to be taken
into account when checking the safety components Ö for lifts Õ will be defined by joint agreement between all
the notified bodies responsible for this procedure, taking into consideration
the essential characteristics of the safety components Ö for
lifts Õ referred to in Annex III
IV.

Ö On
request, the notified body shall provide the Commission and the Member states
with a copy of the certificate of conformity. Õ

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

Ö 6. Under the responsibility of the
notified body, the manufacturer shall affix the identification number of the
notified body adjacent to the CE marking in accordance with Articles 18 and 19 to
the safety components for lifts during the manufacturing process. Õ

3. The manufacturer of the safety components or
his authorized representative must keep a copy of the EC declaration of
conformity for a period of 10 years after the last safety component has been
manufactured.

Ö The manufacturer or his authorized
representative must keep a copy of the EU declaration of conformity for a
period of 10 years after the last safety component has been manufactured. Õ

Where neither the
manufacturer of the
safety components nor his authorized representative are
established in the Community
Ö Union Õ, the obligation to keep the technical documentation
available falls to the person who places the safety components Ö for
lifts Õ on the Ö Union Õ market.

5.7. The Ö documents Õ dossiers and correspondence
relating to the random checking procedures referred to in Section
Point 4 Ö shall Õ must be drawn up in one of the
official languages of the Member State where the notified body is established
or in a language acceptable to it.

ê 95/16/EC (adapted)

ð new

ANNEX X XII

PRODUCT QUALITY
ASSURANCE FOR LIFTS

(module E)

1. Product quality assurance is the procedure
whereby the installer of a lift who satisfies Section 2 ensures and declares
that the lifts installed are in conformity with the type as described in the EC
type-examination certificate and satisfy the requirements of the Directive that apply to them.

The installer of a lift must affix the CE marking
to each lift and draw up an EC declaration of conformity. The CE marking must
be accompanied by the identification number of the notified body responsible
for surveillance as specified in Section 4.

2. The installer of a lift must apply an approved
quality assurance system for final inspection of the lift and testing as
specified in Section 3, and must be subject to surveillance as specified in
Section 4.

Ö 1. Product quality assurance is the part of the
conformity assessment procedure whereby a notified body assesses the product
quality assurance system of an installer to ensure that the lifts installed are
in conformity with the type as described in the EU type-examination certificate or with a lift designed and manufactured by an
installer who operates a full quality assurance system in accordance with Annex
XI, and
satisfy the essential health and safety requirements set out in Annex
I. Õ

Ö 2. Obligations of the installer Õ

Ö 2.1. The installer shall apply an approved
product quality assurance system for final inspection and testing of the lift
as specified in Point 3, and shall be subject to surveillance as specified in
Point 4. Õ

Ö 2.2. The
installer shall affix the CE marking to each lift and draw up an EU declaration
of conformity. Õ

3. Ö product Õ Quality assurance system

3.1. The installer of a lift Ö shall Õ must lodge an application for
assessment of his Ö product Õ quality assurance system for the lifts
concerned with a ð single ï notified body of his choice.

The application Ö shall Õ must include:

ò new

(a)        the
name and address of the installer;

ê 95/16/EC (adapted)

(b)- all relevant information Ö on the
lifts to be installed Õ
for the lifts envisaged,;

(c)- the documentation on the Ö product Õ quality assurance system,;

(d)- the technical documentation Ö file Õ on the approved lifts and a copy of the EC type-examination certificates, Ö of the lifts to be installed; Õ

ò new

(e) a written declaration that
the same application has not been lodged with any other notified body.

ê 95/16/EC (adapted)

3.2. Under the Ö product Õ quality assurance system, each lift Ö shall Õ must be examined and appropriate
tests as set out in the relevant standards referred to in Article 514 or equivalent tests Ö shall Õ must be carried out in order to
ensure its conformity to the relevant requirements of the Directive Ö to the essential health and safety requirements set out in
Annex I Õ .

All the elements,
requirements and provisions adopted by the installer of a lift Ö shall Õ must be documented in a
systematic and orderly manner in the form of written measures, procedures and
instructions. This Ö product Õ quality assurance system documentation Ö shall Õ must ensure a common
understanding of the quality programmes, plans, manuals and quality records.

It Ö shall Õ must contain in
particular an adequate description of:

(a)- the quality objectives,;

(b)- the organizational structure, responsibilities and powers of the
management with regard to lift quality,;

(c)- the examinations and tests that will be carried out before placing
on the market, including at the very
least the tests laid down in Point 3.3.(b) of
Annex VI, 4 (b),;

(d)- the means to verify the effective operation of the Ö product Õ quality assurance system,;

ê 95/16/EC

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

ê 95/16/EC (adapted)

ð new

3.3. The notified body Ö shall Õ must assess the Ö product Õ quality assurance system to determine whether it satisfies the
requirements referred to in Section
Point
3.2. It must Ö shall Õ presume conformity with these requirements in respect of quality
assurance systems that implement the relevant harmonized standard[33].

The auditing team must
Ö shall Õ have at least one member with experience of assessment in the lift
technology concerned ð and knowledge of the essential health
and safety requirements set out in Annex I. ï The assessment procedure must
Ö shall Õ include a visit to the premises of the lift
installer and a visit to the installation site.

The decision must Ö shall Õ be notified to the lift installer. The
notification must contain the conclusions of the examination and the reasoned assessment Ö approval Õ decision.

3.4. The installer of a lift
must
Ö shall Õ undertake to discharge the obligations arising
from the Ö product Õ quality assurance system as approved and to
ensure that it is maintained in an appropriate and efficient manner.

The installer of a lift
must keep the notified body which has approved the quality Ö product Õ assurance system informed of any intended
updating of the quality
assurance system.

The notified body must Ö shall Õ assess the modifications proposed and decide
whether the modified Ö product Õ quality assurance system still satisfies the
requirements referred to in Section Point 3.2 or whether a reassessment is
required.

It must Ö shall Õ notify its decision to the lift
installer. The notification must contain the conclusions of the examination
Ö assessment Õ and the reasoned assessment decision.

ò new

The
notified body shall affix, or cause to be affixed, its identification number
adjacent to the CE marking in accordance with Articles 18 and 21.

ê 95/16/EC (adapted)

4. Surveillance under the responsibility of the notified body

4.1. The purpose of
surveillance is to make sure that the installer of a lift duly fulfils the
obligations arising out of the approved Ö product Õ quality assurance system.

4.2. The installer of a lift
must
Ö shall Õ allow the notified body access for inspection
purposes to the inspection and testing locations and provide it with all
necessary information, in particular:

(a)- the Ö product Õ quality assurance system documentation,;

(b)- the technical Ö file(s) Õ documentation,;

ê 95/16/EC

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

ê 95/16/EC (adapted)

4.3. The notified body must Ö shall Õ periodically carry out audits to ensure that
the installer of a
lift maintains and applies the quality assurance system and must Ö shall Õ provide an audit report to the lift
installer.

ê 95/16/EC

4.4. Additionally, the
notified body may pay unexpected visits to the lift installation sites.

ê 95/16/EC
(adapted)

At the time of such
visits, the notified body may, where
necessary, carry out tests or have them carried out in order to
check the proper functioning of the Ö product Õ quality assurance system where
necessary and of the lift;.
it must Ö It shall Õ provide the lift installer with a visit
report and, if a test has been carried out, with a test report.

5. The installer of a lift,
must Ö shall Õ for a period of 10 years after the last lift has been Ö installed Õ manufactured
, keep at the disposal of the national authorities:

ê 95/16/EC
(adapted)

(a)- the documentation referred to in the third indent of the
second paragraph of Section Point 3.1(c),;

ò new

(b)
the technical file referred to in Point 3.1(d);

ê 95/16/EC
(adapted)

(c)- the updating referred to in the second
paragraph of Section Point
3.4,;

(d)- the decisions and reports from the notified body which are referred
to in the final paragraph of Section
Point
3.4 and in Sections Points 4.3
and 4.4.

6. Each notified body must forward to the other
notified bodies the relevant information concerning the quality assurance
system approvals issued and withdrawn.

ò new

6. Each notified
body shall inform its notifying authorities of product quality assurance system
approval decision(s) issued or withdrawn, and shall, periodically or upon
request, make available to its notifying authorities the list of approval
decisions, issued, refused, suspended or otherwise restricted.

Each notified
body shall inform the other notified bodies of product quality assurance system
approval decision(s) which it has refused, suspended or withdrawn and, upon
request, of approval decision(s) which it has issued.

On request, the
notified body shall provide the Commission and the Member States with a copy of
product quality assurance system approval decision(s) issued.

7. The documents
and correspondence relating to the product quality assurance procedures shall
be drawn up in one of the official languages of the Member State where the
notified body is established or in a language acceptable to it.

ê 95/16/EC (adapted)

ð new

ANNEX XI XIII

FULL QUALITY
ASSURANCE Ö PLUS DESIGN EXAMINATION Õ FOR LIFTS

(module H)

1. Full quality assurance is the procedure whereby
the installer of a lift who satisfies the obligations of Section 2 ensures and
declares that lifts satisfy the requirements of the Directive that apply to
them.

The installer of a lift must affix the CE
marking on each lift and draw up an EC declaration of conformity. The CE
marking must be accompanied by the identification number of the notified body
responsible for the surveillance as specified in Section 4.

2. The installer of a lift must operate an approved
quality assurance system for design, manufacture, assembly, installation and
final inspection of the lifts and testing as specified in Section 3 and must be
subject to surveillance as specified in Section 4.

Ö 1. Full quality assurance plus design examination for lifts
is the conformity assessment procedure whereby a notified body assesses the
full quality assurance system of an installer and, where appropriate, the
design of the lifts, to ensure that the lifts installed satisfy the essential health
and safety requirements set out in Annex I. Õ

Ö 2. Obligations of the installer Õ

Ö 2.1. The installer shall operate an approved full quality
assurance system for the design, manufacture, assembly, installation, final
inspection and testing of lifts as specified in Point 3 and shall be subject to
surveillance as specified in Point 4. Õ

Ö 2.2. The
installer must affix the CE marking on each lift and draw up an EU declaration
of conformity. The CE marking must be accompanied by the identification number
of the notified body responsible for the surveillance as specified in Point 4. Õ

3. Ö full Õ Quality assurance system

3.1. The installer of a lift must Ö shall Õ lodge an application for assessment of his Ö full Õ quality assurance system with a ð single ï notified body ð of his choice ï .

The application must Ö shall Õ include:

ò new

(a)        the
name and address of the installer;

ê 95/16/EC
(adapted)

(b)- all relevant information on the lifts Ö to be
installed Õ , in
particular information which makes for an understanding of the relationship
between the design and operation of the lift and enables conformity
with the requirements of the Directive to be assessed,;

ê 95/16/EC

(c)- the documentation on the quality assurance
system,;

ò new

(d) a technical
file according to Annex IV B for one model of lift;

(e) a
written declaration that the same application has not been lodged with any
other notified body.

ê 95/16/EC (adapted)

3.2. The quality assurance
system must ensure conformity of the lifts with the requirements of the
Directive that apply to them.

All the elements,
requirements and provisions adopted by the lift installer must Ö shall Õ be documented in a systematic and orderly manner in the
form of written measures, procedures and instructions. This quality assurance
system documentation must Ö shall Õ ensure a common understanding of the procedures such as
programmes, plans, manuals and quality records.

It Ö shall Õ must contain in particular an
adequate description of:

ê 95/16/EC

(a)- the quality objectives and the organizational
structure, responsibilities and powers of the management with regard to the
design and quality of the lifts,;

ê 95/16/EC (adapted)

(b)- the technical design specifications, including
standards that will be applied and, where the standards referred to in Article 514 of the Directive will Ö are Õ not be applied
Ö or not
applied Õ in full, the means that will be used to ensure that the Ö applicable essential health
and safety Õ requirements of the Directive that apply to the lifts will be
met,;

ê 95/16/EC
(adapted)

(c)- the design control and design verification
techniques, processes and systematic actions that will be used when designing
the lifts,;

(d)- the examinations and tests that will be carried
out on acceptance of the supplies of materials, components and sub-assemblies,;

(e)- the corresponding assembly, installation and
quality control techniques, processes and systematic actions that will be used,;

(f)- the examinations and tests that will be carried
out before (inspection of installation conditions: shaft, housing of machinery,
etc.), during and after installation (including at the very least the tests
laid down in Point 3.4 (e) of Annex V Annex VI, Section 4 (b)),;

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

(h)- the means of monitoring the achievement of the
required design and installation quality and the effective operation of the
quality assurance system.

ê 95/16/EC (adapted)

3.3. Design inspection

3.3.1. When
the design is not entirely in accordance with harmonized standards, the
notified body must ascertain whether the design conforms to the provisions Ö essential
health and safety requirements set out in Annex I Õ of the Directive and, if it
does, issue an 'EC Ö EU Õ design examination certificate' to the installer, stating the
limits of the certificate's validity and giving the details required for
identification of the approved design.

ò new

3.3.2. Where the
design does not satisfy the applicable requirements of this Directive, the
notified body shall refuse to issue a design examination certificate and shall
inform the installer accordingly, giving detailed reasons for its refusal.

The notified body
shall keep itself apprised of any changes in the generally acknowledged state
of the art which indicate that the approved design may no longer comply with
the essential health and safety requirements set out in Annex I, and shall
determine whether such changes require further investigation. If so, the
notified body shall inform the installer accordingly.

The installer
shall keep the notified body that has issued the EU design examination
certificate informed of any modification to the approved design that may affect
the conformity with the essential health and safety requirements set out in
Annex I or the conditions for validity of the certificate. Such modifications
shall require additional approval — from the notified body that issued the EU
design examination certificate — in the form of an addition to the original EU
design examination certificate.

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

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

The Commission,
the Member States and the other notified bodies may, on request, obtain a copy
of the EU design examination certificates and/or additions thereto. On request,
the Commission and the Member States may obtain a copy of the technical files
and of the results of the examinations carried out by the notified body.

3.3.4. The
installer shall keep a copy of the EU design examination certificate, its
annexes and additions together with the technical file at the disposal of the
national authorities for 10 years after the lift has been placed on the market.

ê 95/16/EC (adapted)

ð new

3.4. Assessment of the Ö full Õ quality assurance system

The notified body must assess the Ö full Õ quality assurance system to determine whether it satisfies the
requirements referred to in Section
Point
3.2. It Ö shall Õ must presume compliance
with these requirements in respect of Ö full Õ quality assurance systems that implement the relevant harmonized
standard[34].

The auditing team Ö shall Õ must have at least one member
with experience of assessment in the lift technology concerned ð and knowledge of the
essential health and safety requirements set out in Annex I. ï The assessment procedure Ö shall Õ must include a visit to the lift
installer's premises and a visit to an installation site.

ò new

The
auditing team shall review the technical file referred to in point 3.1, to
verify the installer’s ability to identify the essential health and safety
requirements of set out in Annex I and to carry out the necessary examinations
with a view to ensuring compliance of the lift with those requirements.

ê 95/16/EC (adapted)

The decision Ö shall Õ must be notified to the lift
installer. The notification must contain the conclusions of the examination
Ö assessment Õ and the
reasoned assessment Ö report Õ decision.

3.5. The lift
installer Ö shall Õ must undertake to discharge the
obligations arising from the Ö full Õ quality assurance system as approved and to
ensure that it is maintained in an appropriate and efficient manner.

The lift
installer Ö shall Õ must keep the notified body that
has approved the Ö full Õ quality assurance system informed of any
intended updating of the quality assurance system.

The notified body Ö shall Õ must assess the modifications
proposed and decide whether the modified Ö full Õ quality assurance system will still satisfy the
requirements referred to in Section Point 3.2 or whether a reassessment is
required.

It Ö shall Õ must notify its decision to the lift
installer. The notification must contain the conclusions of the examination
Ö assessment Õ and the reasoned assessment Ö approval Õ decision.

ò new

The
notified body shall affix, or cause to be affixed, its identification number
adjacent to the CE marking in accordance with Articles 18 and 21.

ê 95/16/EC (adapted)

4. Surveillance under the responsibility of the notified body

4.1. The purpose of
surveillance is to make sure that the installer of a lift duly fulfils the
obligations arising out of the approved Ö full Õ quality assurance system.

4.2. The lift
installer Ö shall Õ must allow the notified body
access for inspection purposes to the design, manufacture, assembly,
installation, inspection and testing and storage locations, and Ö shall Õ must provide it with all
necessary information, in particular:

(a)- the Ö full Õ quality assurance system documentation,;

ê 95/16/EC

(b)- the quality
records provided for in the design part of the quality assurance system, such
as results of analyses, calculations, tests, etc.,;

(c)- the quality
records provided for in the part of the quality assurance system concerning
acceptance of supplies and installation, such as inspection reports and test
data, calibration data, reports on the qualifications of the personnel
concerned, etc.

4.3. The notified body must periodically
carry out audits to make sure that the installer of a lift maintains and
applies the quality assurance system and must provide the installer with an
audit report.

ê 95/16/EC
(adapted)

4.4. Additionally, the
notified body may pay unexpected visits to the premises of a lift installer or
to the assembly site of a lift. At the time of such visits, the notified body
may, Ö where necessary, Õ carry out tests or have them carried out in
order to check the proper functioning of the Ö full Õ quality assurance system, where necessary; it must
Ö It shall Õ provide the lift installer with a visit
report and, if a test has been carried out, with a test report.

5. The installer Ö shall Õ of a lift must, for a period of
10 years after the lift has been placed on the market, keep at the disposal of
the national authorities:

(a)- the documentation referred to in the second indent of the
second paragraph of Section
Point
3.1(c),;

ò new

(b) a technical
file referred to in Point 3.1(d);

ê 95/16/EC
(adapted)

(c)- the Ö updates Õ updating
referred to in the second paragraph of Section
Point
3.5,;

ê 95/16/EC

(d)- the decisions
and reports from the notified body which are referred to in the final paragraph
of Section
Point 3.5 and in Sections
Points 4.3 and 4.4.

ê 95/16/EC
(adapted)

Where the installer is
not established in the Ö Union Õ
Community, this obligation falls to the notified body.

6. Each notified body shall forward to the
other notified bodies the relevant information concerning the quality assurance
systems issued and withdrawn.

ò new

6.
Each notified body shall inform its notifying authorities of full quality
assurance system approvals issued or withdrawn, and shall, periodically or upon
request, make available to its notifying authorities the list of full quality
assurance system approval decision(s) issued, refused, suspended or otherwise
restricted.

Each
notified body shall inform the other notified bodies of full quality assurance
system approval decision(s) which it has refused, suspended or withdrawn, and,
upon request, of full quality assurance system approval decision(s) which it
has issued.

The
notified body shall keep a copy of the approval decision(s) issued, its annexes
and additions, as well as the technical file for a period of 15 years from the
date of their issue.

On
request, the notified body shall provide the Commission and the Member States
with a copy of full quality assurance system approval decision(s) issued.

ê 95/16/EC (adapted)

7. The dossiers
Ö documents Õ and correspondence relating to the full quality assurance
procedures must be drawn up in one of the official languages of the Member
State where the notified body is established or in a language acceptable to it.

ê 95/16/EC (adapted)

ANNEX XII XIV

PRODUCTION
QUALITY ASSURANCE Ö FOR LIFTS Õ

(module D)

1. Production quality assurance is the
procedure whereby the installer of a lift who satisfies the obligations of
Section 2 ensures and declares that the lifts satisfy the requirements of the
Directive that apply to them. The installer of the lift must affix the CE
marking to each lift and draw up a written
declaration of conformity. The CE marking must be accompanied by the
identification symbol of the notified body responsible for surveillance as
specified in Section 4.

2. The installer of the lift must operate an
approved quality assurance system for production, installation, final lift
inspection and testing as specified in Section 3 and is subject to surveillance
as specified in Section 4.

Ö 1. Production quality assurance for lifts is the
part of the conformity assessment procedure whereby a notified body assesses
the production quality assurance system of a installer to ensure that the lifts
installed are in conformity with the type as described in the EU
type-examination certificate or with a lift designed and manufactured by an
installer who operates a full quality assurance system in accordance with Annex
XI, and satisfy the essential health and safety requirements set out in Annex
I. Õ

Ö 2. Obligations of the installer Õ

Ö 2.1. The installer shall operate an approved
production quality assurance system for manufacture, assembly, installation,
final inspection and testing of lifts as specified in Point 3 and is subject to
surveillance as specified in Point 4. Õ

Ö 2.2. The
installer shall affix the CE marking to each lift and draw up a written
declaration of conformity. Õ

3. Ö Production Õ Qquality assurance system

3.1. The installer must Ö shall Õ lodge an application for assessment of his Ö production Õ quality assurance system with a notified body
of his choice.

The application must Ö shall Õ include:

ò new

(a) the
name and address of the installer;

ê 95/16/EC (adapted)

(b)- all relevant information for the lifts Ö to be
installed Õ,;

(c)- the documentation concerning Ö on
the production Õ the quality assurance system,;

(d)- the technical documentation Ö file Õ of Ö the lifts
to be installed Õ
the approved type and a copy of the EC
type-examination certificate,;

ò new

(e) a
written declaration that the same application has not been lodged with any
other notified body.

ê 95/16/EC

3.2. The quality
assurance system must ensure compliance of the lifts with the requirements of
the Directive that apply to them.

ê 95/16/EC (adapted)

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

It Ö shall Õ must contain in
particular an adequate description of:

(a)- the quality
objectives and the organizational structure, responsibilities and powers of the
management with regard to the quality of the lifts,;

(b)- the
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
installation[35],;

(d)- the quality
records, such as inspection reports and test data, calibration data,
qualification reports of the personnel concerned, etc.,;

(e)- the means to monitor the achievement of
the required lift quality and the effective operation of the Ö production Õ quality
assurance system.

3.3. The notified body Ö shall Õ must assess the Ö production Õ quality assurance system to determine
whether it satisfies the requirements referred to in Section Point 3.2.
It presumes conformity with these requirements in respect of quality assurance
systems that implement the relevant harmonized standard[36].

The auditing team must Ö shall Õ have at least one member with experience of assessment in
the lift technology concerned Ö and knowledge of the requirements set out in Annex I. Õ

The assessment procedure must
Ö shall Õ include an
inspection visit to the installer's premises Ö and a
visit to an installation site Õ.

The decision Ö shall Õ must be notified to the
installer. The notification must contain the conclusions of the examination
Ö assessment Õ and the
reasoned assessment Ö report Õ decision.

3.4. The installer Ö shall Õ must undertake to discharge the
obligations arising from the Ö production Õ quality
assurance system as approved and to ensure that it is maintained in an
appropriate and efficient manner.

The installer shall
keep the notified body that has approved the Ö production Õ quality assurance system informed of any
intended updating of the quality assurance system.

The notified body Ö shall Õ must assess the modifications
proposed and decide whether the modified Ö production Õ quality assurance system will still satisfy the
requirements referred to in Section Point 3.2 or whether a re-assessment is
required.

It Ö shall Õ must notify its decision to the
installer. The notification must contain the conclusions of the examination
Ö assessment Õ and the
reasoned assessment Ö report Õ decision.

4. Surveillance under the responsibility of the notified body

4.1. The purpose of
surveillance is to make sure that the installer duly fulfils the obligations
arising out of the approved Ö production Õ quality
assurance system.

4.2. The installer Ö shall Õ must allow the notified body
access for inspection purposes to the manufacture, inspection, assembly,
installation, testing and storage locations and must provide it with all
necessary information, in particular:

(a)- the Ö production Õ quality assurance system documentation,;

Ö (b) the technical file(s); Õ

ê 95/16/EC

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

ê 95/16/EC (adapted)

4.3. The notified body Ö shall Õ must periodically carry out
audits to make sure that the installer maintains and applies the quality Ö production Õ assurance system and Ö shall Õ must provide an audit report to
the installer.

4.4. Additionally the
notified body may pay unexpected visits to the installer. During such visits
the notified body may, where necessary carry out, or cause to be carried
out, tests to verify that the Ö production Õ quality
assurance system is functioning correctly, if necessary.
The notified body Ö shall Õ must provide the installer with
a visit report and, if a test has taken place, with a test report.

5. The installer Ö shall Õ must, for a period of 10 years
after the last lift has been manufactured, keep at the disposal of the national
authorities:

ê 95/16/EC
(adapted)

(a)- the documentation referred to in the second indent of
Section Point 3.1(c),;

ò new

(b)
the technical file referred to in Point 3.1(d);

ê 95/16/EC

(c)- the updating referred to in the second
paragraph of Section Point
3.4,;

(d)- the decisions and reports from the
notified body which are referred to in the final paragraph of Section
Points 3.4, Section
4.3 and 4.4.

ò new

6. Each
notified body shall inform its notifying authorities of production quality
assurance system approvals issued or withdrawn, and shall, periodically or upon
request, make available to its notifying authorities the list of production
quality assurance system approval decision(s) issued, refused, suspended or
otherwise restricted.

Each
notified body shall inform the other notified bodies of production quality
assurance system approval decision(s) which it has refused, suspended or
withdrawn, and, upon request, of production quality assurance system approval
decision(s) which it has issued.

On
request, the notified body shall provide the Commission and the Member States
with a copy of production quality assurance system approval decision(s) issued.

ê 95/16/EC
(adapted)

6. Each notified body must give the other notified
bodies the relevant information concerning the quality assurance system
approvals issued and withdrawn.

7. Ö The documentation Õ Documents
and correspondence relating to the production quality
assurance procedures shall be drawn up in an official language of the Member
State in which the notified body is established or in a language acceptable to
it.

é

ANNEX XIII

Part A

Repealed Directive
with list of its successive amendments

European Parliament and Council Directive 95/16/EC (OJ L 213, 7.9.1995, p. 1) ||

Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p.1) || Only Pt. 10) of Annex I

Directive 2006/42/EC of the European Parliament and the Council (OJ L 157, 9.6.2006, p.24) || Only Article 24

Part B

List of
time-limits for transposition into national law [and application]

Directive || Time-limit for transposition || Date of application

95/16/EC || 1 January 1997 || 1 July 1997[37]

2006/42/EC Art.24 || 29 June 2008 || 29 December 2009

ANNEX XIV

Correlation Table

Directive 95/16/EC || This Directive

Article 1(1) || Article 1(1) first subparagraph

­__ || Article 1(1), second subparagraph

Article 1(2) first subparagraph || __

Article 1(2), second subparagraph || __

Article 1(2), third subparagraph || Article 2(2)

Article 1(3) || Article 1(2)

Article 1(4) first indent of first subparagraph || Article 2(4)

Article 1(4) second, third and fourth indents of first subparagraph || __

Article 1(4) fifth indent of first subparagraph || Article 2(3)

Article 1(4) second subparagraph || Article 16(3)

Article 1(4) third subparagraph || Article 16(4)

Article 1(5) || Article 1(3)

_ || Article 2(1)

Article 2(1) first indent || Article 4(1)

Article 2(1) second indent || Article 4(2)

Article 2(2) || Article 6(1)

Article 2(3) || Article 6(2)

Article 2(4) || Article 3(4)

Article 2(5) || Article 3(3)

Article 3, first paragraph || Article 5(1)

Article 3, second paragraph || Article 5(2)

Article 4(1) || Article 3(1)

Article 4(2) || Article 3(2)

__ || Articles 7 to 14

Article 5 || __

Article 6(1) and (2) || __

||

Article 6(3) and (4) || Article 42

Article 7 || __

__ || Articles 37 to 41

_ || Article 43

Article 8(1) (a) || Article 15

Article 8(1) (b) and (c) || __

Article 8(2) || Article 16

__ || Article 17

Article 8(3), (4) and (5) || __

__ || Article 18

Article 9 || __

Article 10(1) || __

Article 10(2) || Article 19(1)

Article 10(3) and (4) || __

__ || Article 19(2) to (5)

__ || Articles 20 to 45

Article 11 || __

__ || Article 44

Article 12 || __

Article 13 || __

Article 14 || __

Article 15(1) and (2) || __

||

Article 15(3) || Article 46(2)

__ || Article 46(1)

Article 16 || _

__ || Articles 47 to 49

Article 17 || Article 50

Annex I || Annex I

Annex II Part A || Annex II Part A

Annex II Part B || Annex II Part B

Annex III || __

Annex IV || Annex III

Annex V Part A || Annex IV Part A

Annex V Part B || Annex IV Part B

Annex VI || Annex V

Annex VII || __

Annex VIII || Annex VI

Annex IX || Annex VII

Annex X || Annex VIII

Annex XI || Annex IX

Annex XII || Annex X

Annex XIII || Annex XI

Annex XIV || Annex XII

__ || Annex XIII

__ || Annex XIV

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

[2]               Evaluation of the Application of the Lift
Directive (95/16/EC). Final Report to the European Commission (DG ENTR) of
21 June 2004. [The study examined the functioning of the Directive 95/16/EC in
7 Member States: Belgium, Finland, Germany, Italy, Portugal, Spain and the
United Kingdom.]

[3]               Study on the Technical Assessment of Means of
Preventing the Crushing Risk on Lifts subject to Directive 95/16/EC, Report
Number ME/07/07 (2007). [The study aim was the examination whether the
solutions available, other than free space or refuges, to prevent the crushing
risk can provide an equivalent level of safety.]

[4]               Proposal for a Regulation of the European Parliament
and of the Council on European Standardisation and amending Council Directives
89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC,
98/34/EC, 2004/22/EC, 2007/23/EC, 2009/105/EC and 2009/23/EC of the European
Parliament and of the Council. COM(2011) 315 final

[5]               C(2010) 7649 final

[6]               OJ C 77, 28.3.2002, p. 1–3

[7]               OJ C [...].

[8]               OJ No L 300, 19. 11. 1984, p. 86. Directive as
last amended by Directive 90/486/EEC (OJ No L 270, 2. 10. 1990, p. 21).

[9]               OJ No L 300, 19. 11. 1984, p. 72. Directive as
last amended by Directive 88/665/EEC (OJ No L 382, 31. 12.
1988, p. 42).

[10]             OJ No L 384, 31. 12. 1986, p. 12.

[11]             OJ No L 198, 22. 7. 1991, p. 16.

[12]             OJ No L 213, 7. 9. 1995, p. 1.

[13]             OJ L 218, 13.8.2008, p. 30.

[14]             OJ L 218, 13.8.2008, p. 82.

[15]             OJ No L 134, 20. 6. 1995, p. 37.

[16]             OJ No L 220, 30. 8. 1993, p. 23.

[17]             OJ No L 109, 26. 4. 1983, p. 8. Directive as last
amended by European Parliament and Council Directive 94/10/EC (OJ No L 100,
19. 4. 1994, p. 30).

[18]             OJ No L
40, 11. 2. 1989, p. 12.

[19]             OJ C [...], [Date], p. [...].

[20]             OJ L 157, 9.06.2006, p. 24.

[21]             OJ No L 390, 31.12.2004, p. 24.

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

[23]             OJ L
157, 9.06.2006, p. 24.

[24]             The declaration must be drafted in the same
language as the instruction manual referred to in Annex I, Section 6.1, and be
either typewritten or printed.

[25]             Business name, full address; in the case of an
authorized representative, also indicate the business name and address of the
manufacturer of the safety components.

[26]             Business name, full address; in the case of an
authorized representative, also indicate the business name and address of
the manufacturer of the safety components.

[27]             This declaration must be drafted in the same
language as the instruction manual referred to in Annex I, Section 6.2, and be
either typewritten or printed.

[28]             Business name and full address.

[29]             If the notified body deems it necessary, it may
either issue an addition to the original EC type-examination certificate or ask
for a fresh application to be submitted.

[30]             If the notified body deems it necessary, it may
either issue an addition to the original EC type-examination certificate or
ask for a fresh application to be submitted.

[31]             This harmonized standard will be EN 29003,
supplemented where necessary to take account of the specific features of safety
components.

[32]             This harmonized standard will be EN 29001,
supplemented where necessary to take account of the specific features of safety
components.

[33]             This harmonized standard will be EN 29003,
supplemented where necessary to take account of the specific features of the
lifts.

[34]             This harmonized standard will be EN 29001,
supplemented where necessary to take account of the specific features of the
lifts.

[35]             These tests include at least
the tests provided for in Annex V Point 3.4VI, Section 4 (b).

[36]             This harmonized standard will be EN 29002,
supplemented where necessary to take account of the specific nature of the
lifts.

[37]             Until 30 June 1999 Member States shall allow: — the
placing on the market and putting into service of lifts, — the placing on the
market and putting into service of safety components, which conform to the provisions
in force in their territories on the date of adoption of this Directive. See
Article 15(2) of Directive 95/16/EC.