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 proces