Report - A8-0063/2015Report
A8-0063/2015
European Parliament

REPORT on the proposal for a regulation of the European Parliament and of the Council on cableway installations

25.3.2015 - (COM(2014)0187 – C7‑0111/2014 – 2014/0107(COD)) - ***I

Committee on the Internal Market and Consumer Protection
Rapporteur: Antonio López-Istúriz White


Procedure : 2014/0107(COD)
Document stages in plenary
Document selected :  
A8-0063/2015
Texts tabled :
A8-0063/2015
Debates :
Votes :
Texts adopted :

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the proposal for a regulation of the European Parliament and of the Council on cableway installations

(COM(2014)0187 – C7‑0111/2014 – 2014/0107(COD))

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2014)0187),

–  having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7‑0111/2014),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on the Internal Market and Consumer Protection (A8-0063/2015),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Amendment    1

Proposal for a regulation

Recital 3 a (new)

Text proposed by the Commission

Amendment

 

(3a) This Regulation applies to new cableway installations and covers subsystems and safety components which are new to the Union market when they are placed on the market; that is to say they are either new subsystem and safety components made by a manufacturer established in the Union or subsystems and safety components, whether new or second-hand, imported from a third country. This Regulation does not apply to the relocation of cableway installations installed on the territory of the Union or to the relocation of subsystems or safety components that were incorporated into such installations, except where such relocation implies a major modification of the installation that would need administrative authorisation.

Amendment    2

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(7) Regulation (EU) No […/…] [on market surveillance of products]16 provides detailed rules on market surveillance and on controls of products entering the Union from third countries, including subsystems and safety components. It also sets out a safeguard clause procedure. Member States are to organise and carry out market surveillance, appoint market surveillance authorities and specify their powers and duties. They are also to set up general and sector-specific market surveillance programs.

deleted

__________________

 

16 OJ L […...].

 

Amendment    3

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

(8) The scope of Directive 2000/9/EC should be maintained. This Regulation should apply to cableway installations designed to transport persons used in high-altitude tourist resorts or in urban transport facilities. Cableway installations are mainly lift systems, such as funicular railways, aerial ropeways, cable cars, gondolas, chairlifts and drag lifts. Traction by cable and the passenger transport function are the essential criteria determining the cableway installations covered by this Regulation.

(8) The scope of Directive 2000/9/EC should be maintained. This Regulation should apply to cableway installations designed to transport persons, typically used in tourist resorts or in urban transport facilities. Cableway installations are mainly lift systems, such as funicular railways, aerial ropeways, cable cars, gondolas, chairlifts drag lifts and other installations for tourism or sport purposes. Traction by cable and the passenger transport function are the essential criteria determining the cableway installations covered by this Regulation.

Amendment    4

Proposal for a regulation

Recital 11

Text proposed by the Commission

Amendment

(11) Cable-operated lifts, whether vertical or inclined, permanently serving specific levels of buildings and constructions other than the stations, are subject to specific Union legislation and should be excluded from the scope of this Regulation.

(11) Lifts, including cable-operated lifts, whether vertical or inclined, permanently serving specific levels of buildings and constructions and not operating between cableway stations, are subject to specific Union legislation and should be excluded from the scope of this Regulation.

Amendment    5

Proposal for a regulation

Recital 11 a (new)

Text proposed by the Commission

Amendment

 

(11a) Cableway installations of historical construction, as identified by national law, and their subsystems and safety components should be excluded from the scope of this Regulation. Member States should ensure a high level protection of the health and safety of persons and of property concerning those cableway installations, if necessary through their national law.

Amendment    6

Proposal for a regulation

Recital 14 a (new)

Text proposed by the Commission

Amendment

 

(14a) The precautionary principle, as laid down in Article 191(2) TFEU and outlined inter alia in the Commission Communication of 2 February 2000 on the precautionary principle, is a fundamental principle for the safety of products and for the safety of consumers and should be taken into due account when laying down the criteria for assessing the safety of cableway installations and their infrastructure, subsystems and safety components.

Amendment    7

Proposal for a regulation

Recital 15

Text proposed by the Commission

Amendment

(15) This Regulation does not affect the right of the Member States to specify the requirements they deem necessary as regards land-use, regional planning and in order to ensure the protection of the environment and of the health and safety of persons and in particular workers when using cableway installations.

(15) This Regulation does not affect the right of the Member States to specify the requirements they deem necessary as regards land-use, regional planning and in order to ensure the protection of the environment and of the health and safety of persons and in particular workers and operators when using cableway installations.

Amendment    8

Proposal for a regulation

Recital 19 a (new)

Text proposed by the Commission

Amendment

 

(19a) In order to ensure legal certainty, it is necessary to clarify that rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to subsystems and safety components covered by this Regulation. This Regulation should not prevent Member States from choosing the competent authorities to carry out those tasks.

Amendment    9

Proposal for a regulation

Recital 20

Text proposed by the Commission

Amendment

(20) Member States should take the necessary steps to ensure that cableway installations enter into service only if they comply with this Regulation and they are not liable to endanger the health and safety of persons or property when properly installed, maintained and operated in accordance with their intended purpose.

(20) Member States should take the necessary steps to ensure that cableway installations enter into service only if they comply with this Regulation and they are not liable to endanger the health or safety of persons or property when properly installed, maintained and operated in accordance with their intended purpose.

Amendment    10

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

(25) Subsystems and safety components should be allowed to be incorporated in a cableway installation provided that they permit the construction of cableway installations which comply with this Regulation and are not liable to endanger the health and safety of persons or property when properly installed, maintained and operated in accordance with their intended purpose.

(25) Subsystems and safety components should be allowed to be incorporated in a cableway installation provided that they permit the construction of cableway installations which comply with this Regulation and are not liable to endanger the health or safety of persons or property when properly installed, maintained and operated in accordance with their intended purpose.

Amendment    11

Proposal for a regulation

Recital 31

Text proposed by the Commission

Amendment

(31) It is necessary to ensure that subsystems and safety components from third countries entering the Union market comply with the requirements of this Regulation, and in particular that appropriate conformity assessment procedures have been carried out by manufacturers with regard to those subsystems and safety components. Provision should therefore be made for importers to make sure that the subsystem or safety component they place on the market comply with the requirements of this Regulation and that they do not place on the market subsystems and safety components which do not comply with such requirements or present a risk. Provision should also be made for importers to make sure that conformity assessment procedures have been carried out and that subsystem and safety component marking and documentation drawn up by manufacturers are available for inspection by the competent supervisory authorities.

(31) It is necessary to ensure that subsystems and safety components from third countries entering the Union market comply with the requirements of this Regulation, and in particular that appropriate conformity assessment procedures have been carried out by manufacturers with regard to those subsystems and safety components. Provision should therefore be made for importers to make sure that the subsystem or safety component they place on the market comply with the requirements of this Regulation and that they do not place on the market subsystems and safety components which do not comply with such requirements or present a risk. Provision should also be made for importers to make sure that conformity assessment procedures have been carried out and that subsystem and safety component marking and documentation drawn up by manufacturers are available for inspection by the competent national authorities.

Amendment    12

Proposal for a regulation

Recital 33

Text proposed by the Commission

Amendment

(33) When placing on the market a subsystem or a safety component, every importer should indicate on the subsystem or safety component his name, registered trade name or registered trade mark and the postal address at which he can be contacted. Exceptions should be provided for in cases where the size or nature of the safety component does not allow it. This includes cases where the importer would have to open the packaging to put his name and address on the safety component.

(33) When placing on the market a subsystem or a safety component, every importer should indicate on the subsystem or safety component his name, registered trade name or registered trade mark and the postal address at which he can be contacted, as well as a website where available. Exceptions should be provided for in cases where the size or nature of the subsystem or safety component does not allow it. This includes cases where the importer would have to open the packaging to put his name and address on the subsystem or safety component. In such cases the information should be indicated on the packaging and in the instructions accompanying the safety component.

Amendment    13

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) This Regulation should be limited to the expression of the essential requirements. In order to facilitate conformity assessment with those requirements it is necessary to provide for presumption of conformity for cableway installations which are in conformity with harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 for the purpose of expressing detailed technical specifications of those requirements, especially with regard to the design, construction and operation of cableway installations.

(37) This Regulation should be limited to the expression of the essential requirements. In order to facilitate conformity assessment with those requirements it is necessary to provide for presumption of conformity for cableway installations, subsystems and safety components which are in conformity with harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 for the purpose of expressing detailed technical specifications of those requirements, especially with regard to the design, construction and operation of cableway installations.

Amendment    14

Proposal for a regulation

Recital 41

Text proposed by the Commission

Amendment

(41) To ensure effective access to information for market surveillance purposes, the information required to identify all applicable Union acts for a subsystem or a safety component should be available in a single EU declaration of conformity.

(41) To ensure effective access to information for market surveillance purposes, the information required to identify all applicable Union acts for a subsystem or a safety component should be available in a single EU declaration of conformity. In order to reduce the administrative burden on economic operators, that single EU declaration of conformity may be a dossier made up of the relevant individual declarations of conformity.

Amendment    15

Proposal for a regulation

Recital 43

Text proposed by the Commission

Amendment

(43) A check of compliance of subsystems and safety components with the essential requirements provided for in this Regulation is necessary in order to provide effective protection for users and third parties.

(43) A check of compliance of subsystems and safety components with the essential requirements provided for in this Regulation is necessary in order to provide effective protection for operators, users and third parties.

Amendment    16

Proposal for a regulation

Recital 46

Text proposed by the Commission

Amendment

(46) Experience has shown that the criteria set out in Directive 2000/9/EC that conformity assessment bodies have to fulfil in order to be notified to the Commission are not sufficient to ensure a uniformly high level of performance of these bodies throughout the Union. It is, however, essential that all conformity assessment bodies perform their functions to the same level and under conditions of fair competition. That requires the setting of obligatory requirements for conformity assessment bodies wishing to be notified in order to provide conformity assessment services.

(46) Experience has shown that the criteria set out in Directive 2000/9/EC that conformity assessment bodies have to fulfil in order to be notified to the Commission are not sufficient to ensure a uniformly high level of performance of 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.

Amendment    17

Proposal for a regulation

Recital 54

Text proposed by the Commission

Amendment

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

(54) 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.

Amendment    18

Proposal for a regulation

Recital 54 a (new)

Text proposed by the Commission

Amendment

 

(54a) Directive 2000/9/EC already provides for a safeguard procedure which is necessary to allow the possibility for contesting the conformity of a subsystem or safety component. In order to increase transparency and to reduce processing time, it is necessary to improve the existing safeguard procedure, with a view to making it more efficient and drawing on the expertise available in the Member States.

Amendment    19

Proposal for a regulation

Recital 54 b (new)

Text proposed by the Commission

Amendment

 

(54b) The existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to subsystems and safety components presenting a risk to the health or safety of persons. It should also allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an earlier stage in respect of such subsystems and safety components.

Amendment    20

Proposal for a regulation

Recital 56 a (new)

Text proposed by the Commission

Amendment

 

(56a) When matters relating to this Regulation, other than its implementation or infringements, are being examined, i.e. in a Commission expert group, the European Parliament should in line with existing practice receive full information and documentation and an invitation to attend such meetings.

Amendment    21

Proposal for a regulation

Recital 57

Text proposed by the Commission

Amendment

(57) It is necessary to provide for transitional arrangements that allow the making available on the market and the putting into service of subsystems and safety components that have already been placed on the market in accordance with Directive 2000/9/EC.

(57) It is necessary to provide for transitional arrangements that allow the making available on the market and the entry into service, without the need to comply with further product requirements, of subsystems and safety components that have already been placed on the market in accordance with Directive 2000/9/EC.

Amendment    22

Proposal for a regulation

Recital 59

Text proposed by the Commission

Amendment

(59) Member States should lay down rules on penalties applicable to infringements to this Regulation and ensure that they are implemented. Those penalties must be effective, proportionate and dissuasive.

(59) Member States should lay down rules on penalties applicable to infringements to this Regulation and ensure that they are enforced. The penalties provided for should be effective, proportionate and dissuasive.

Amendment    23

Proposal for a regulation

Recital 60

Text proposed by the Commission

Amendment

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

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

Amendment    24

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

This Regulation lays down rules on the design and construction of cableway installations designed to transport persons and on the making available on the market and the free movement of subsystems and safety components for such installations.

This Regulation lays down rules on the making available on the market and the free movement of subsystems and safety components for cableway installations. It also contains rules on the design, construction and entry into service of new cableway installations.

Amendment    25

Proposal for a regulation

Article 1 a (new)

Text proposed by the Commission

Amendment

 

Article 1a

 

The provisions of this Regulation are based on the precautionary principle.

Amendment    26

Proposal for a regulation

Article 2 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) cable-operated tramways of traditional construction;

(b) cableway installations of historical construction, including cable-operated tramways, funicular railways and cliff railways, as identified by national law, including subsystems and safety components specifically designed for them;

Amendment    27

Proposal for a regulation

Article 2 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) installations intended for agricultural purposes and for the service of mountain shelters and huts that are not intended for the transport of the public;

(c) installations intended for agricultural or forestry purposes;

Amendment    28

Proposal for a regulation

Article 2 – paragraph 2 – point c a (new)

Text proposed by the Commission

Amendment

 

(ca) cableway installations for the service of mountain shelters and huts intended only for the transport of goods and specifically authorised persons;

Amendment    29

Proposal for a regulation

Article 2 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d) on-site or mobile equipment for use in fairgrounds and/or amusement parks which are exclusively designed for leisure purposes and not as a means for transporting persons;

(d) on-site or mobile equipment exclusively designed for leisure and amusement purposes and not as a means for transporting persons;

Amendment    30

Proposal for a regulation

Article 3 – point 3

Text proposed by the Commission

Amendment

(3) "infrastructure" means the layout, system data, station structures and structures along the line especially designed for each installation and constructed on site and which are needed for the construction and the operation of the installation, including the foundations;

(3) "infrastructure" means station structures and structures along the line especially designed for each cableway installation and constructed on site, which take into account the layout and the data of the system and which are needed for the construction and the operation of the cableway installation, including the foundations;

Amendment    31

Proposal for a regulation

Article 3 – point 18

Text proposed by the Commission

Amendment

(18) "technical specification" means a document that prescribes technical requirements to be fulfilled by an installation, infrastructure, subsystem or safety component;

(18) "technical specification" means a document that prescribes technical requirements to be fulfilled by a cableway installation, infrastructure, subsystem or safety component;

Amendment    32

Proposal for a regulation

Article 3 – point 24

Text proposed by the Commission

Amendment

(24) "recall" means any measure aimed at achieving the return of a subsystem or a safety component that has already been incorporated into a cableway installation;

(24) "recall" means any measure aimed at achieving the return of a subsystem or a safety component that has already been made available for the design and construction of a cableway installation;

Amendment    33

Proposal for a regulation

Article 4 – paragraph 1

Text proposed by the Commission

Amendment

(1) Member States shall take all appropriate measures to ensure that subsystems and safety components are made available on the market only if they satisfy the requirements of this Regulation.

(1) Subsystems and safety components shall only be made available on the market if they satisfy the requirements of this Regulation.

Amendment    34

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

(2) Member States shall take all appropriate measures, in accordance with Article 9, to determine the procedures to ensure that the subsystems and safety components are incorporated into cableway installations only if they enable the construction of cableway installations which satisfy the requirements of this Regulation and are not liable to endanger the health and safety of persons or property when properly incorporated, maintained and operated in accordance with their intended purpose.

deleted

Amendment    35

Proposal for a regulation

Article 5 – paragraph 1

Text proposed by the Commission

Amendment

(1) Member States shall take all appropriate measures in accordance with Article 9, to determine the procedures to ensure that cableway installations enter into service only if they satisfy the requirements of this Regulation and they are not liable to endanger the health and safety of persons or property when properly installed, maintained and operated in accordance with their intended purpose.

(1) Member States shall take all appropriate measures in accordance with Article 9, to determine the procedures to ensure that cableway installations enter into service only if they satisfy the requirements of this Regulation and they are not liable to endanger the health or safety of persons or property when properly installed, maintained and operated in accordance with their intended purpose.

Amendment    36

Proposal for a regulation

Article 5 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

(1a) Member States shall take all appropriate measures, in accordance with Article 9, to determine the procedures for ensuring that the subsystems and safety components are incorporated into cableway installations only if they enable the construction of cableway installations which satisfy the requirements of this Regulation and are not liable to endanger the health or safety of persons or property when properly incorporated, maintained and operated in accordance with their intended purpose.

Amendment    37

Proposal for a regulation

Article 5 – paragraph 2

Text proposed by the Commission

Amendment

(2) Cableway installations which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential requirements covered by those standards or parts thereof, referred to in Annex II.

(2) Cableway installations which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential requirements set out in Annex II covered by those standards or parts thereof.

Amendment    38

Proposal for a regulation

Article 8 – paragraph 1

Text proposed by the Commission

Amendment

1. All planned installations shall be subject to a safety analysis as defined in Annex III which shall cover all safety aspects of the cableway installation and its environment in the context of the design, construction and entry into service and shall make it possible to identify from past experience risks liable to occur during the operation of the cableway installation.

1. The person responsible for the cableway installation, determined by a Member State in accordance with national law, shall carry out a safety analysis of the planned cableway installation or have such safety analysis carried out.

Amendment    39

Proposal for a regulation

Article 8 – paragraph 2

Text proposed by the Commission

Amendment

(2) The safety analysis shall be included in a safety report. That report shall recommend the measures envisaged to deal with such risks and include a list of the subsystems and safety components to be incorporated into the cableway installation.

deleted

Amendment    40

Proposal for a regulation

Article 8 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

(2a) The safety analysis required for every cableway installation shall take into account every mode of operation envisaged. The safety analysis shall follow a recognised or established method and take into account the current state of the art and the complexity of the cableway installation in question. The aim of that safety analysis shall be to ensure that the design and configuration of the cableway installation take into account the local surroundings and the most adverse situations in order to ensure satisfactory safety conditions. The safety analysis shall cover all safety aspects of the cableway installation and its external factors in the context of the design, construction and entry into service and shall make it possible to identify, from past experience, risks liable to occur during the operation of the cableway installation.

Amendment    41

Proposal for a regulation

Article 8 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

 

(2b) The safety analysis shall also cover the safety devices and their effect on the cableway installation and related subsystems that they bring into action so that either:

 

(a) they are capable of reacting to an initial breakdown or failure detected so as to remain either in a state that guarantees safety, in a lower operating mode or in a fail-safe state;

 

(b) they are redundant and are monitored; or

 

(c) they are such that the probability of their failure can be evaluated and they are of a standard equivalent to that achieved by safety devices that meet the criteria in the first and second indents.

 

Safety analysis shall be used to draw up the inventory of risks and dangerous situations, to recommend the measures envisaged to deal with such risks and to determine the list of subsystems and safety components to be incorporated into the cableway installation. The result of the safety analysis shall be included in a safety report.

Amendment    42

Proposal for a regulation

Article 9 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States shall ensure that the safety analysis, the safety report, the EU declaration of conformity and the other documents relating to the conformity of subsystems and safety components as well as the documentation concerning the characteristics of the cableway installation are submitted to the authority responsible for approving the cableway installation. The documentation concerning the cableway installation shall also include the necessary conditions, including the restrictions on operation, and full details for servicing supervision, adjustment and maintenance of the cableway installation. A copy of those documents shall be kept at the cableway installation.

2. The person responsible for the cableway installation, determined by a Member State in accordance with national law, shall submit the safety report, as referred to in Article 8, the EU declaration of conformity and the other documents relating to the conformity of subsystems and safety components as well as the documentation concerning the characteristics of the cableway installation to the authority or body responsible for approving the cableway installation. The documentation concerning the cableway installation shall also include the necessary conditions, including the restrictions on operation, and full details for servicing supervision, adjustment and maintenance of the cableway installation. A copy of those documents shall be kept at the cableway installation.

Amendment    43

Proposal for a regulation

Article 9 – paragraph 4

Text proposed by the Commission

Amendment

(4) Member States shall not use the provisions referred to in paragraph 1 to prohibit, restrict or hinder, on grounds related to the aspects covered by this Regulation, the construction and the entry into service of cableway installations which comply with this Regulation and do not present a risk to the health and safety of persons or to property when properly installed in accordance with their intended purpose.

(4) Member States shall not use the provisions referred to in paragraph 1 to prohibit, restrict or hinder, on grounds related to the aspects covered by this Regulation, the construction and the entry into service of cableway installations which comply with this Regulation and do not present a risk to the health or safety of persons or to property when properly installed in accordance with their intended purpose.

Amendment    44

Proposal for a regulation

Article 10 – paragraph 2

Text proposed by the Commission

Amendment

(2) If a Member State finds that an approved cableway installation which is used in accordance with its intended purpose is liable to endanger the health and safety of persons and, where appropriate, property, it shall take all appropriate measures to restrict the conditions of operation of the cableway installation or to prohibit the operation thereof.

(2) If a Member State finds that an approved cableway installation which is used in accordance with its intended purpose is liable to endanger the health or safety of persons, or endanger property, it shall take all appropriate measures to restrict the conditions of operation of the cableway installation or to prohibit the operation thereof.

Amendment    45

Proposal for a regulation

Article 11 – paragraph 5 – subparagraph 1

Text proposed by the Commission

Amendment

Manufacturers shall ensure that their subsystems or safety components are accompanied by the EU declaration of conformity and that they bear a type, batch or serial number or other element allowing their identification.

Manufacturers shall ensure that subsystems or safety components which they have placed on the market bear a type, batch or serial number allowing their identification.

Amendment    46

Proposal for a regulation

Article 11 – paragraph 5 – subparagraph 2

Text proposed by the Commission

Amendment

Where the size or nature of the safety component does not allow it, manufacturers shall ensure that the required information is provided on the packaging or in the instructions accompanying the safety component.

Where the size or nature of the subsystem or the safety component does not allow it, manufacturers shall ensure that the required information is provided on the packaging and in the documents accompanying the subsystem or the safety component.

Amendment    47

Proposal for a regulation

Article 11 – paragraph 6

Text proposed by the Commission

Amendment

(6) Manufacturers shall indicate on the subsystem or the safety component their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on the packaging and in the instructions accompanying the safety component. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by users and the market surveillance authorities as determined by the Member State concerned.

(6) Manufacturers shall indicate on the subsystem or the safety component their name, registered trade name or registered trade mark and the postal address at which they can be contacted, as well as a website where available or, where that is not possible, on the packaging and in the document accompanying the subsystem or the safety component. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by users and the market surveillance authorities as determined by the Member State concerned.

Amendment    48

Proposal for a regulation

Article 11 – paragraph 7

Text proposed by the Commission

Amendment

(7) Manufacturers shall ensure that the subsystem or the safety component is accompanied by the EU Declaration of conformity and by instructions and safety information, in a language which can be easily understood by users, as determined by the Member State concerned. Such instructions and safety information shall be clear, understandable and intelligible.

(7) Manufacturers shall ensure that the subsystem or the safety component is accompanied by a copy of the EU declaration of conformity and by instructions and safety information as set out in Annex II, point 7.1.1, in a language which can be easily understood by users, as determined by the Member State concerned. Such instructions and safety information shall be clear, understandable and intelligible.

Amendment    49

Proposal for a regulation

Article 11 – paragraph 8

Text proposed by the Commission

Amendment

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

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

Amendment    50

Proposal for a regulation

Article 11 – paragraph 9

Text proposed by the Commission

Amendment

(9) Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the subsystem or the safety component with this Regulation, in a language which can be easily understood by that authority. That information and documentation may be provided in paper or electronic form. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by the subsystems or safety components which they have placed on the market.

(9) Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the subsystem or the safety component with this Regulation, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by the subsystems or safety components which they have placed on the market.

Amendment    51

Proposal for a regulation

Article 12 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) keep the EU declaration of conformity and the technical documentation at the disposal of national surveillance authorities for 30 years after the subsystem or the safety component has been placed on the market;

(a) keep the EU declaration of conformity and the technical documentation at the disposal of national market surveillance authorities for 30 years after the subsystem or the safety component has been placed on the market;

Amendment    52

Proposal for a regulation

Article 13 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

Before placing on the market a subsystem or a safety component, importers shall ensure that the appropriate conformity assessment procedure in accordance with Article 18 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the subsystem or the safety component is accompanied by the EU declaration of conformity, that it bears the CE marking and is accompanied by instructions and safety information and that the manufacturer has complied with the requirements set out in Article 11(5) and (6) respectively.

Before placing on the market a subsystem or a safety component, importers shall ensure that the appropriate conformity assessment procedure referred to in Article 18 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the subsystem or the safety component is accompanied by a copy of the EU declaration of conformity, that it bears the CE marking and is accompanied by instructions and safety information and that the manufacturer has complied with the requirements set out in Article 11(5) and (6).

Amendment    53

Proposal for a regulation

Article 13 – paragraph 3

Text proposed by the Commission

Amendment

(3) Importers shall indicate their name, registered trade name or registered trade mark and the postal address at which they can be contacted on the subsystem or the safety component or where that is not possible, on its packaging and in the instructions accompanying the safety component. The contact details shall be in a language easily understood by users and market surveillance authorities as determined by the Member State concerned.

(3) Importers shall indicate on the subsystem or the safety component their name, registered trade name or registered trade mark and the postal address at which they can be contacted, as well as a website where available, or where that is not possible, on its packaging and in a document accompanying the subsystem or the safety component. The contact details shall be in a language easily understood by users and market surveillance authorities as determined by the Member State concerned.

Amendment    54

Proposal for a regulation

Article 13 – paragraph 5

Text proposed by the Commission

Amendment

(5) Importers shall ensure that, while a subsystem or a safety component is under their responsibility, storage or transport conditions do not jeopardise their compliance with the requirements set out in Annex II.

(5) Importers shall ensure that, while a subsystem or a safety component is under their responsibility, storage or transport conditions do not jeopardise their compliance with the essential requirements set out in Annex II.

Amendment    55

Proposal for a regulation

Article 13 – paragraph 6

Text proposed by the Commission

Amendment

(6) When deemed appropriate with regard to the risks presented by a subsystem or a safety component, importers shall, to protect the health and safety of the users, upon a duly justified request of the competent authorities, carry out sample testing of subsystems or safety components made available on the market, investigate, and, if necessary, keep a register of complaints of nonconforming subsystems or safety components and recalls of such subsystems or safety components, and shall keep distributors informed of any such monitoring.

(6) When deemed appropriate with regard to the risks presented by a subsystem or a safety component, importers shall, to protect the health and safety of the passengers, operating personnel and third parties, carry out sample testing of subsystems or safety components made available on the market, investigate, and, if necessary, keep a register of complaints of nonconforming subsystems or safety components and recalls of such subsystems or safety components, and shall keep distributors informed of any such monitoring.

Amendment    56

Proposal for a regulation

Article 13 – paragraph 9

Text proposed by the Commission

Amendment

(9) Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a subsystem or a safety component in a language which can be easily understood by that authority. That information and documentation may be provided in paper or electronic form. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by subsystems or safety components which they have placed on the market.

(9) Importers shall, further to a request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of a subsystem or a safety component 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 subsystems or safety components which they have placed on the market.

Amendment    57

Proposal for a regulation

Article 14 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

Before making a subsystem or a safety component available on the market distributors shall verify that the subsystem or the safety component bears the CE marking and it is accompanied by the EU declaration of conformity and by instructions and safety information in a language which can be easily understood by users as determined by the Member State concerned, and that the manufacturer and the importer have complied with the requirements set out in Article 11(5) and (6) and Article 13(3).

Before making a subsystem or a safety component available on the market distributors shall verify that the subsystem or the safety component bears the CE marking and it is accompanied by a copy of the EU declaration of conformity and by instructions and safety information in a language which can be easily understood by users as determined by the Member State concerned, and that the manufacturer and the importer have complied with the requirements set out in Article 11(5) and (6) and Article 13(3)..

Amendment    58

Proposal for a regulation

Article 14 – paragraph 5

Text proposed by the Commission

Amendment

(5) Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a subsystem or a safety component. That information and documentation may be provided in paper or electronic form. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by the subsystem or the safety component which they have made available on the market.

(5) Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of a subsystem or a safety component. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by the subsystem or the safety component which they have made available on the market.

Amendment    59

Proposal for a regulation

Article 17

Text proposed by the Commission

Amendment

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

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

Amendment    60

Proposal for a regulation

Article 18 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) conformity based on full quality assurance (Module H), set out in Annex VIII.

(c) conformity based on full quality assurance plus design examination (Module H 1), set out in Annex VIII.

Amendment    61

Proposal for a regulation

Article 18 – paragraph 5

Text proposed by the Commission

Amendment

(5) Records and correspondence relating to conformity assessment shall be drawn up in the official language(s) of the Member State where the body carrying out the procedures referred to in paragraph 2 is established or in a language accepted by that body.

(5) Records and correspondence relating to the conformity assessment procedures shall be drawn up in the official language(s) of the Member State where the body carrying out the procedures referred to in paragraph 2 is established or in a language accepted by that body.

Amendment    62

Proposal for a regulation

Article 19 – paragraph 2

Text proposed by the Commission

Amendment

(2) The EU declaration of conformity shall have the model structure set out in Annex X and shall contain the elements specified in the relevant conformity assessment procedures set out in Annexes IV to VIII and shall be continuously updated. It shall accompany the subsystem or the safety component and shall be translated into the language or languages required by the Member State in whose market the subsystem or the safety component is placed or made available on the market.

(2) The EU declaration of conformity shall have the model structure set out in Annex X and shall contain the elements specified in the relevant modules set out in Annexes IV to VIII and shall be updated when the subsystem or safety component is placed on the market. It shall accompany the subsystem or the safety component and shall be translated into the language or languages required by the Member State in which the subsystem or the safety component is placed or made available on the market.

Amendment    63

Proposal for a regulation

Article 21 – paragraph 1

Text proposed by the Commission

Amendment

(1) The CE marking shall be affixed visibly, legibly and indelibly to the subsystem or the safety component or to their data plate.

(1) The CE marking shall be affixed visibly, legibly and indelibly to the subsystem or the safety component or to their data plate. Where that is not possible or not warranted on account of the nature of the subsystem or the safety component, it shall be affixed to the packaging and to the accompanying documents.

Amendment    64

Proposal for a regulation

Article 21 – paragraph 3

Text proposed by the Commission

Amendment

(3) The CE marking shall be followed by the identification number of the notified body involved in the production control phase.

(3) The CE marking shall be followed by the identification number of the notified body involved in the production control phase. The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative.

Amendment    65

Proposal for a regulation

Article 21 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

 

(4a) Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.

Amendment    66

Proposal for a regulation

Article 22 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks in accordance with Article 18.

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

Amendment    67

Proposal for a regulation

Article 23 – paragraph 1

Text proposed by the Commission

Amendment

(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.

(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 28.

Amendment    68

Proposal for a regulation

Article 23 – paragraph 3

Text proposed by the Commission

Amendment

(3) Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 to a body which is not a governmental entity that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 26(1) to (6). In addition it shall have arrangements to cover liabilities arising out of its activities.

(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 24. In addition it shall have arrangements to cover liabilities arising out of its activities.

Amendment    69

Proposal for a regulation

Article 25 – title

Text proposed by the Commission

Amendment

Information obligation of notifying authorities

Information obligation on notifying authorities

Amendment    70

Proposal for a regulation

Article 26 – paragraph 1

Text proposed by the Commission

Amendment

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

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

Amendment    71

Proposal for a regulation

Article 26 – paragraph 10

Text proposed by the Commission

Amendment

(10) The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annexes IV to VIII or any provision of national law giving effect to them, except in relation to the competent authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.

(10) The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annexes IV to VIII or any provision of national law giving effect to it, except in relation to the competent authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.

Amendment    72

Proposal for a regulation

Article 27 – title

Text proposed by the Commission

Amendment

Presumption of conformity

Presumption of conformity of notified bodies

Amendment    73

Proposal for a regulation

Article 30 – paragraph 6

Text proposed by the Commission

Amendment

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

(6) The notifying authority shall notify the Commission and the other Member States of any subsequent relevant changes to the notification.

Amendment    74

Proposal for a regulation

Article 31 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

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

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

Amendment    75

Proposal for a regulation

Article 31 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

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

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

Amendment    76

Proposal for a regulation

Article 32 – paragraph 1

Text proposed by the Commission

Amendment

(1) Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 26 or that it is failing to fulfil its obligations, the notifying authority shall, as appropriate, restrict, suspend or withdraw the notification, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.

(1) Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 26 or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw the 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.

Amendment    77

Proposal for a regulation

Article 33 – paragraph 4 – subparagraph 2

Text proposed by the Commission

Amendment

The implementing act referred to in the first subparagraph shall be adopted in accordance with the advisory procedure referred to in Article 39(2).

That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 39(2).

Amendment    78

Proposal for a regulation

Article 34 – paragraph 3

Text proposed by the Commission

Amendment

(3) Where a notified body finds that essential requirements set out in Annex II or corresponding harmonised standards or other technical specifications have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue a conformity certificate.

(3) Where a notified body finds that essential requirements set out in Annex II or corresponding harmonised standards or other technical specifications have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue a certificate of conformity.

Amendment    79

Proposal for a regulation

Article 35

Text proposed by the Commission

Amendment

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

Notified bodies shall ensure that an appeal procedure against their decisions is available.

Amendment    80

Proposal for a regulation

Article 36 – title

Text proposed by the Commission

Amendment

Information obligation of notified bodies

Information obligation on notified bodies

Amendment    81

Proposal for a regulation

Article 38 – paragraph 1

Text proposed by the Commission

Amendment

The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Regulation are put in place and properly operated in the form of a sectoral group or groups of notified bodies.

The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Regulation are put in place and properly operated in the form of the coordination group of notified bodies for cableway installations.

Amendment    82

Proposal for a regulation

Article 38 – paragraph 2

Text proposed by the Commission

Amendment

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

Notified bodies shall participate in the work of that group, directly or by means of designated representatives.

Amendment    83

Proposal for a regulation

Chapter IV a (new)

Text proposed by the Commission

Amendment

 

CHAPTER IVa

 

UNION MARKET SURVEILLANCE, CONTROL OF SUBSYSTEMS AND SAFETY COMPONENTS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE

Amendment    84

Proposal for a regulation

Article 38 a (new)

Text proposed by the Commission

Amendment

 

Article 38a

 

Union market surveillance and control of subsystems and safety components entering the Union market

 

Article 15(3) and Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to subsystems and safety components covered by this Regulation.

Amendment    85

Proposal for a regulation

Article 38 b (new)

Text proposed by the Commission

Amendment

 

Article 38b

 

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

 

1. Where the market surveillance authorities of one Member State have sufficient reason to believe that a subsystem or safety component covered by this Regulation presents a risk to the health or safety of persons, they shall carry out an evaluation in relation to the subsystem or safety component concerned covering all relevant requirements laid down in this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose.

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

(a) failure of the subsystem or safety component to meet requirements relating to the health or safety of persons or the protection of property; or

 

(b) shortcomings in the harmonised standards referred to in Article 17 conferring a presumption of conformity.

 

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

 

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

 

8. Member States shall ensure that appropriate restrictive measures, such as withdrawal of the subsystem or safety component from the market, are taken in respect of the subsystem or safety component concerned without delay.

Amendment    86

Proposal for a regulation

Article 38 c (new)

Text proposed by the Commission

Amendment

 

Article 38c

 

Union safeguard procedure

 

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

 

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

 

2. If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant subsystem or safety component is withdrawn from their market, and shall inform the Commission accordingly. If the national measure is considered unjustified, the Member State concerned shall withdraw that measure.

 

3. Where the national measure is considered justified and the non-compliance of the subsystem or safety component is attributed to shortcomings in the harmonised standards referred to in point (b) of Article 38b(5) of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.

Amendment    87

Proposal for a regulation

Article 38 d (new)

Text proposed by the Commission

Amendment

 

Article 38d

 

Compliant subsystems or safety components which present a risk to health or safety

 

1. Where, having carried out an evaluation under Article 38a(1), a Member State finds that although a subsystem or safety component is in compliance with this Regulation, it presents a risk to the health or safety of persons, it shall require the relevant economic operator to take all appropriate measures to ensure that the subsystem or safety component concerned, when placed on the market, no longer presents that risk, to withdraw the subsystem or safety component from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe.

 

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

 

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

 

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

 

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

Amendment    88

Proposal for a regulation

Article 38 e (new)

Text proposed by the Commission

Amendment

 

Article 38e

 

Formal non-compliance

 

1. Without prejudice to Article 38b, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:

 

(a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 21 of this Regulation;

 

(b) the CE marking has not been affixed;

 

(c) the identification number of the notified body involved in the production control phase has been affixed in violation of Article 21 or has not been affixed;

 

(d) the EU declaration of conformity does not accompany the subsystem or safety component;

 

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

 

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

 

(g) the technical documentation is either not available or not complete.

 

(h) the information referred to in Article 11(6) or Article 13(3) is absent, false or incomplete;

 

(i) any other administrative requirement provided for in Article 11 or Article 13 is not fulfilled.

 

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

Amendment    89

Proposal for a regulation

Article 40 – paragraph 2

Text proposed by the Commission

Amendment

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

The penalties provided for shall be effective, proportionate and dissuasive. The penalties shall have regard to the seriousness, the duration and, where applicable, the intentional character of the infringement. In addition, the penalties shall have regard to whether the relevant economic operator has previously committed a similar infringement.

Amendment    90

Proposal for a regulation

Article 41 – paragraph 2

Text proposed by the Commission

Amendment

Member States shall not impede the entry into service of cableway installations covered by Directive 2000/9/EC which are in conformity with that Directive and which were constructed before [the date referred to in Article 43(2)].

Member States shall not impede the entry into service of cableway installations covered by Directive 2000/9/EC which are in conformity with that Directive and which were installed before [the date referred to in Article 43(2)].

Amendment    91

Proposal for a regulation

Article 41 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

For safety components, certificates and approval decisions issued under Directive 2000/9/EC shall be valid under this Regulation.

Amendment    92

Proposal for a regulation

Article 42 – paragraph 2

Text proposed by the Commission

Amendment

References to the repealed Directive shall be construed as references to this Regulation and shall be read with in accordance with the correlation table laid down in Annex X.

References to the repealed Directive shall be construed as references to this Regulation and shall be read with in accordance with the correlation table laid down in Annex XI.

Amendment    93

Proposal for a regulation

Article 43 – paragraph 3

Text proposed by the Commission

Amendment

By way of derogation from paragraph 2, Articles 22 to 38 shall apply from [six months after entry into force].

By way of derogation from paragraph 2, Articles 22 to 35 and Articles 39 and 40(3) shall apply from [six months after entry into force].

Amendment    94

Proposal for a regulation

Annex II – point 1

Text proposed by the Commission

Amendment

This Annex sets out the essential requirements, including maintainability and operability, applicable to the design, construction and entry into service of cableway installations.

This Annex sets out the essential requirements, including maintainability and operability, applicable to the design, construction and entry into service of cableway installations, and applicable to subsystems and safety components.

Amendment    95

Proposal for a regulation

Annex II – part 4 – point 4.2 – point 4.2.3 – point 4.2.3.3

Text proposed by the Commission

Amendment

4.2.3.3. In all cableway installations there shall be two or more braking systems, each capable of bringing the cableway installation to a halt, and coordinated in such a way that they automatically replace the active system when its efficiency becomes inadequate. The traction cable's last braking system shall act directly on the driving pulley. These provisions do not apply to drag lifts.

4.2.3.3. In all cableway installations there shall be two or more braking systems, each capable of bringing the cableway installation to a halt, and coordinated in such a way that they automatically replace the active system when its efficiency becomes inadequate. The installation's last braking system shall act as close as possible to the traction cable, or on one or several pulleys including the driving pulley or in the vehicle. These provisions do not apply to drag lifts.

Amendment    96

Proposal for a regulation

Annex III

Text proposed by the Commission

Amendment

ANNEX III

deleted

SAFETY ANALYSIS

 

The safety analysis required according to Article 8 for every cableway installation shall take into account every mode of operation envisaged. The analysis shall follow a recognised or established method and take into account the current state of the art and the complexity of the cableway installation in question. The aim is also to ensure that the design and configuration of the cableway installation should take account of the local surroundings and the most adverse situations in order to ensure satisfactory safety conditions.

 

The safety analysis shall also cover the safety devices and their effect on the cableway installation and related subsystems that they bring into action so that either:

 

– they are capable of reacting to an initial breakdown or failure detected so as to remain either in a state that guarantees safety, in a lower operating mode or in a fail-safe state,

 

– they are redundant and are monitored, or

 

– they are such that the probability of their failure can be evaluated and they are of a standard equivalent to that achieved by safety devices that meet the criteria in the first and second indents.

 

Safety analysis must be used to draw up the inventory of risks and dangerous situations in accordance with Article 8(1) and to determine the list of safety components referred to in Article 8(2) thereof. The result of the safety analysis shall be summarised in a safety report.

 

Amendment    97

Proposal for a regulation

Annex IV – point 1

Text proposed by the Commission

Amendment

1. EU type-examination is the part of a conformity assessment procedure in which a notifiedbody examines the technical design of a subsystem or a safety component and verifies and attests that it meets the requirements of this Regulation.

1. EU type-examination is the part of a conformity assessment procedure in which a notified body examines the technical design of a subsystem or a safety component and verifies and attests that the technical design meets the requirements of this Regulation that apply to it.

Justification

Alignment to NLF

Amendment    98

Proposal for a regulation

Annex IV – point 2

Text proposed by the Commission

Amendment

2. EU-type examination is carried out by assessment of the adequacy of the technical design of the subsystem or the safety component through examination of the technical documentation and supporting evidence referred to in point 3, plus examination of a specimen, representative of the production envisaged, of the complete subsystem or safety component (production type).

2. EU-type examination is carried out by assessment of the adequacy of the technical design of the subsystem or the safety component through examination of the technical documentation referred to in point 3, plus examination of a specimen, representative of the production envisaged, of the complete subsystem or safety component (production type).

Amendment    99

Proposal for a regulation

Annex IV – point 4 – point 4.1

Text proposed by the Commission

Amendment

4.1. examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the subsystem or the safety component;

4.1. examine the technical documentation to assess the adequacy of the technical design of the subsystem or the safety component;

Amendment    100

Proposal for a regulation

Annex IV – point 4 – point 4.3

Text proposed by the Commission

Amendment

4.3. where the manufacturer has applied the specifications of the relevant harmonised standards, carry out the appropriate examinations and tests, or have them carried out, to check whether these have been applied correctly;

deleted

Amendment    101

Proposal for a regulation

Annex IV – point 5

Text proposed by the Commission

Amendment

5. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 1.4 and their outcomes. Without prejudice to its obligations vis-à vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

5. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

Amendment    102

Proposal for a regulation

Annex IV – point 6 – paragraph 1

Text proposed by the Commission

Amendment

The certificate and its annexes shall contain all relevant information to allow the conformity of manufactured subsystems and safety components with the examined type to be evaluated and to allow for in-service control.

The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured subsystems and safety components with the examined type to be evaluated and to allow for in-service control. It shall also indicate any conditions to which its issue may be subject and be accompanied by the descriptions and drawings necessary for identification of the approved type.

Amendment    103

Proposal for a regulation

Annex IV – point 8 – paragraph 1

Text proposed by the Commission

Amendment

8. Each notified body shall inform its notifying authorities and the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has issued.

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

Amendment    104

Proposal for a regulation

Annex IV – point 8 – paragraph 2

Text proposed by the Commission

Amendment

The notified body which refuses to issue or withdraws, suspends or otherwise restricts an EU-type examination certificate must inform its notifying authorities and the other notified bodies accordingly, giving the reasons for its decision.

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

Amendment    105

Proposal for a regulation

Annex IV – point 8 – paragraph 3

Text proposed by the Commission

Amendment

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate.

Amendment    106

Proposal for a regulation

Annex V – point 1

Text proposed by the Commission

Amendment

1. Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2.2 and 2.5, and ensures and declares on his sole responsibility that the subsystems or safety components concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Regulation that apply to them.

1. Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the subsystems or safety components concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Regulation that apply to them.

Amendment    107

Proposal for a regulation

Annex V – point 2 – paragraph 1

Text proposed by the Commission

Amendment

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the subsystems or safety components concerned as specified in point 2.3, and shall be subject to surveillance as specified in point 2.4.

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the subsystems or safety components concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.

Amendment    108

Proposal for a regulation

Annex V – point 3 – point 3.3 – paragraph 2

Text proposed by the Commission

Amendment

The audit shall include an assessment visit to the premises where the subsystems or the safety components are manufactured, inspected and tested.

deleted

Amendment    109

Proposal for a regulation

Annex V – point 5 – point 5.1

Text proposed by the Commission

Amendment

5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter's identification number to each individual subsystem or safety component that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Regulation. If the notified body agrees and under its responsibility, the manufacturer may affix the notified body's identification number to the subsystems or safety components during the manufacturing process.

5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter's identification number to each individual subsystem or safety component that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Regulation.

Amendment    110

Proposal for a regulation

Annex V – point 5 – point 5.2 – paragraph 1

Text proposed by the Commission

Amendment

5.2. The manufacturer shall draw up a written EU declaration of conformity for each subsystem or safety component and keep it at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market. The EU declaration of conformity shall identify the subsystem or safety component model for which it has been drawn up.

5.2. The manufacturer shall draw up a written EU declaration of conformity for each subsystem or safety component model and keep it at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market. The EU declaration of conformity shall identify the subsystem or safety component model for which it has been drawn up.

Amendment    111

Proposal for a regulation

Annex V – point 7 – paragraph 1

Text proposed by the Commission

Amendment

7. Each notified body shall inform its notifying authorities of quality system approvals withdrawn, and shall, periodically or upon request, make available to its notifying authorities information related to quality system assessments.

7. Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.

Amendment    112

Proposal for a regulation

Annex V – point 7 – paragraph 2

Text proposed by the Commission

Amendment

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, giving the reasons for its decision.

Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, giving the reasons for its decision, and, upon request, of quality system approvals which it has issued.

 

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

 

The notified body shall keep a copy of each approval decision issued, its annexes and additions.

Amendment    113

Proposal for a regulation

Annex VI – point 1

Text proposed by the Commission

Amendment

1. Conformity to type based on subsystem or safety component verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 3.2, 3.5.1 and 3.6, and ensures and declares on his sole responsibility that the subsystems or safety components concerned, which have been subject to the provisions of point 3.3, are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Regulation.

1. Conformity to type based on subsystem or safety component verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 3.2, 3.5.1 and 3.6, and ensures and declares on his sole responsibility that the subsystems or safety components concerned, which have been subject to the provisions of point 3.3, are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Regulation that apply to them.

Amendment    114

Proposal for a regulation

Annex VI – point 2

Text proposed by the Commission

Amendment

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured subsystems or safety components with the approved type described in the EU-type examination certificate and with the requirements of this Regulation.

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured subsystems or safety components with the approved type described in the EU-type examination certificate and with the requirements of this Regulation that apply to them.

Amendment    115

Proposal for a regulation

Annex VI – point 3 – point 3.1

Text proposed by the Commission

Amendment

3.1. The manufacturer shall lodge an application for subsystem or safety component verification with the notified body of his choice.

deleted

The application shall include:

 

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

 

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

 

(c) all relevant information for the subsystems or safety components approved under module B;

 

(d) the technical documentation of the approved type and a copy of the EU-type examination certificate(s);

 

(e) details of the premises where the subsystem or the safety component (is manufactured) can be examined.

 

Amendment    116

Proposal for a regulation

Annex VI – point 3 – point 3.2 – paragraph 1

Text proposed by the Commission

Amendment

3.2 The notified body shall carry out appropriate examinations and tests, or have them carried out, in order to check the conformity of the subsystems or safety components with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Regulation.

3.2 The notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the subsystems or safety components with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Regulation.

Amendment    117

Proposal for a regulation

Annex VI – point 5 – point 5.2

Text proposed by the Commission

Amendment

5.2. A random sample shall be taken from each lot according to the requirements of this Regulation. All the subsystems or safety components in the sample shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or technical specifications, or equivalent tests, shall be carried out in order to ensure their conformity with the approved type described in the EU-type examination certificate and with the applicable requirements of this Regulation in order to determine whether the lot is accepted or rejected. In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.

5.2. A random sample shall be taken from each lot according to the requirements of this Regulation. All the subsystems or safety components in the sample shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or technical specifications, or equivalent tests, shall be carried out in order to ensure their conformity with the approved type described in the EU-type examination certificate and with the applicable requirements of this Regulation and to determine whether the lot is accepted or rejected. In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.

Amendment    118

Proposal for a regulation

Annex VI – point 6 – point 6.1

Text proposed by the Commission

Amendment

6.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3, the latter's identification number to each individual subsystem or safety component that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of this Regulation.

6.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3, the latter's identification number to each individual subsystem or safety component model that is in conformity with the approved type described in the EU-type examination certificate and satisfies the applicable requirements of this Regulation.

Amendment    119

Proposal for a regulation

Annex VI – point 6 – point 6.2 – paragraph 1

Text proposed by the Commission

Amendment

6.2. The manufacturer shall draw up a written EU declaration of conformity for each subsystem or safety component and keep it at the disposal of the national authorities, for 30 years after the subsystem or the safety component has been placed on the market. The EU declaration of conformity shall identify the subsystem or safety component for which it has been drawn up.

6.2. The manufacturer shall draw up a written EU declaration of conformity for each subsystem or safety component and keep it at the disposal of the national authorities, for 30 years after the subsystem or the safety component has been placed on the market. The EU declaration of conformity shall identify the subsystem or safety component model for which it has been drawn up.

Amendment    120

Proposal for a regulation

Annex VI – point 6 – point 6.2 – paragraph 4

Text proposed by the Commission

Amendment

A copy of the EU declaration of conformity shall be made available upon request. If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the notified body's identification number to the subsystems or safety components.

If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also affix the notified body's identification number to the subsystems or safety components.

Amendment    121

Proposal for a regulation

Annex VI – point 8 – paragraph 1

Text proposed by the Commission

Amendment

The manufacturer's obligations set out in points 2 and 5.1 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

The manufacturer's obligations set out in points 2 and 5.1 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer's obligations set out in points 2 and 5.1.

Amendment    122

Proposal for a regulation

Annex VII – point 1

Text proposed by the Commission

Amendment

1. Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 4.2, 4.3 and 4.5, and ensures and declares on his sole responsibility that the subsystem or safety component concerned, which has been subject to the provisions of point 4.4, is in conformity with the requirements of this Regulation.

1. Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 4.2, 4.3 and 4.5, and ensures and declares on his sole responsibility that the subsystem or safety component concerned, which has been subject to the provisions of point 4.4, is in conformity with the requirements of this Regulation that apply to it.

Amendment    123

Proposal for a regulation

Annex VII – point 3 – point 3.1

Text proposed by the Commission

Amendment

3.1. The manufacturer shall lodge an application for unit verification of a subsystem or a safety component with the notified body of his choice.

deleted

The application shall include:

 

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

 

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

 

(c) the technical documentation for the subsystem or the safety component according to Annex IX;

 

(d) details of the premises where the subsystem or the safety component (is manufactured) can be examined.

 

Amendment    124

Proposal for a regulation

Annex VII – point 3 – point 3.2 – paragraph 1

Text proposed by the Commission

Amendment

3.2 The notified body shall examine the technical documentation for the subsystem or the safety component and shall carry out the appropriate examinations and tests, as set out in the relevant harmonised standards and/or technical specifications, or equivalent tests, to ensure its conformity with the applicable requirements of this Regulation, or have them carried out. In the absence of such a harmonised standard and/or technical specification the notified body concerned shall decide on the appropriate tests to be carried out.

3.2 The notified body shall examine the technical documentation for the subsystem or the safety component and shall carry out the appropriate examinations and tests, set out in the relevant harmonised standards and/or technical specifications, or equivalent tests, to check the conformity with the applicable requirements of this Regulation, or have them carried out. In the absence of such a harmonised standard and/or technical specification the notified body concerned shall decide on the appropriate tests to be carried out.

Amendment    125

Proposal for a regulation

Annex VII – point 3 – point 3.2 – paragraph 3

Text proposed by the Commission

Amendment

If the notified body refuses to issue a certificate of conformity, it shall state in detail the reasons for the refusal and indicate the necessary corrective measures to be taken.

deleted

Amendment    126

Proposal for a regulation

Annex VII – point 3 – point 3.2 – paragraph 4

Text proposed by the Commission

Amendment

When the manufacturer reapplies for unit verification of the subsystem or the safety component concerned, he shall apply to the same notified body.

deleted

Amendment    127

Proposal for a regulation

Annex VII – point 3 – point 3.2 – paragraph 5

Text proposed by the Commission

Amendment

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

deleted

Amendment    128

Proposal for a regulation

Annex VII – point 3 – point 3.2 – paragraph 6

Text proposed by the Commission

Amendment

The manufacturer shall keep the technical documentation and a copy of the certificate of conformity at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market.

The manufacturer shall keep the technical documentation and the certificate of conformity at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market.

Amendment    129

Proposal for a regulation

Annex VIII – heading

Text proposed by the Commission

Amendment

CONFORMITY ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE H: CONFORMITY BASED ON FULL QUALITY ASSURANCE

CONFORMITY ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE H1: CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION

Amendment    130

Proposal for a regulation

Annex VIII – point 1

Text proposed by the Commission

Amendment

1. Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the subsystems or safety components concerned satisfy the requirements of this Regulation.

1. Conformity based on full quality assurance plus design examination is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the subsystems or safety components concerned satisfy the requirements of this Regulation that apply to them.

Amendment    131

Proposal for a regulation

Annex VIII – point 3 – point 3.1 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) all necessary information on the subsystems or safety components to be manufactured;

deleted

Amendment    132

Proposal for a regulation

Annex VIII – point 3 – point 3.1 – paragraph 2 – point e

Text proposed by the Commission

Amendment

(e) details of the premises where the subsystems or safety components are designed, manufactured, inspected and tested;

deleted

Amendment    133

Proposal for a regulation

Annex VIII – point 3 – point 3.3 – paragraph 2

Text proposed by the Commission

Amendment

The audit shall include an assessment visit to the premises where the subsystems or the safety components are designed, manufactured, inspected and tested.

deleted

Amendment    134

Proposal for a regulation

Annex VIII – point 3 – point 3.3 – paragraph 3

Text proposed by the Commission

Amendment

In addition to experience in quality management systems, the auditing team shall have at least one member experienced as assessor in the field of cableway installations and in the technology of the subsystems or safety components concerned, and knowledge of the applicable requirements of this Regulation. The auditing team shall review the technical documentation referred to in point 3.1 to verify the manufacturer's ability to identify the applicable requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the subsystems or the safety components with those requirements.

In addition to experience in quality management systems, the auditing team shall have at least one member experienced as assessor in the field of cableway installations and in the technology of the subsystems or safety components concerned, and knowledge of the applicable requirements of this Regulation. The audit shall include an assessment visit to the premises where the subsystems or the safety components are designed, manufactured, inspected and tested. The auditing team shall review the technical documentation referred to in point 3.1 to verify the manufacturer's ability to identify the applicable requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the subsystems or the safety components with those requirements.

Amendment    135

Proposal for a regulation

Annex VIII – point 3 – point 3.3 – paragraph 5

Text proposed by the Commission

Amendment

The notified body shall notify its decision to the manufacturer or his authorised representative. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

The manufacturer or his authorised representative shall be notified of the decision. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

Amendment    136

Proposal for a regulation

Annex VIII – point 3 – point 3.5 – paragraph 3

Text proposed by the Commission

Amendment

It shall notify the manufacturer of the outcome of the evaluation. In case of a reassessment, it shall notify the manufacturer of its decision. The notification shall contain the conclusions of the assessment and the reasoned assessment decision.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the assessment and the reasoned assessment decision.

Amendment    137

Proposal for a regulation

Annex VIII – point 3 – point 3.5 a (new)

Text proposed by the Commission

Amendment

 

3.5a. Design examination

 

3.5a.1. The manufacturer shall lodge an application for examination of the design with the notified body referred to in point 3.1.

 

3.5a.2. The application shall make it possible to understand the design, manufacture and operation of the subsystem or safety component, and to assess the conformity with the requirements of this Regulation that apply to it.

 

It shall include:

 

(a) the name and address of the manufacturer;

 

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

 

(c) the technical documentation as described in Annex IX.

 

3.5a.3. The notified body shall examine the application, and where the design meets the requirements of this Regulation that apply to the subsystem or safety component it shall issue an EU design examination certificate to the manufacturer. That certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design. That certificate may have one or more annexes attached.

 

That certificate and its annexes shall contain all relevant information to allow the conformity of manufactured subsystems or safety components with the examined design to be evaluated and to allow for in-service control, where applicable.

 

Where the design does not satisfy the applicable requirements of this Regulation, the notified body shall refuse to issue an EU design examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

 

3.5a.4. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of this Regulation, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

 

The manufacturer shall keep the notified body that has issued the EU design examination certificate informed of any modification to the approved design that may affect the conformity with the essential requirements of this Regulation or the conditions for validity of the certificate. Such modifications shall require additional approval – from the notified body that issued the EU design examination certificate – in the form of an addition to the original EU design examination certificate.

 

3.5a.5. Each notified body shall inform its notifying authority of the EU design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of certificates and/or any additions thereto refused, suspended or otherwise restricted.

 

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

 

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU design examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and of the results of the examinations carried out by the notified body.

 

The notified body shall keep a copy of the EU design examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the expiry of the validity of the certificate.

 

3.5a.6. The manufacturer shall keep a copy of the EU design examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 30 years after the subsystem or safety component has been placed on the market.

Amendment    138

Proposal for a regulation

Annex VIII – point 5 – point 5.1 – paragraph 1

Text proposed by the Commission

Amendment

5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter's identification number to each individual subsystem or safety component that is in conformity with the type as described in the EU-type examination certificate and satisfies the applicable requirements of this Regulation.

5.1. The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter's identification number to each individual subsystem or safety component that satisfies the applicable requirements of this Regulation.

Amendment    139

Proposal for a regulation

Annex VIII – point 5 – point 5.1 – paragraph 2

Text proposed by the Commission

Amendment

If the notified body agrees and under its responsibility, the manufacturer may affix the notified body's identification number to the subsystems or safety components during the manufacturing process.

deleted

Amendment    140

Proposal for a regulation

Annex VIII – point 5 – point 5.2 – paragraph 1

Text proposed by the Commission

Amendment

5.2. The manufacturer shall draw up a written EU declaration of conformity for each subsystem or safety component and keep a copy of it at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market. The EU declaration of conformity shall identify the subsystem or the safety component for which it has been drawn up.

5.2. The manufacturer shall draw up a written EU declaration of conformity for each subsystem or safety component model and keep a copy of it at the disposal of the national authorities for 30 years after the subsystem or the safety component has been placed on the market. The EU declaration of conformity shall identify the subsystem or the safety component model for which it has been drawn up.

Amendment    141

Proposal for a regulation

Annex VIII – point 6 – point c

Text proposed by the Commission

Amendment

(c) the documentation relating to the change referred to in point 3.5 as approved;

(c) the information relating to the change referred to in point 3.5, as approved;

Amendment    142

Proposal for a regulation

Annex X – point 1

Text proposed by the Commission

Amendment

(1) The EU declaration of conformity shall accompany the subsystem or the safety component. It shall be drawn up in the same language or languages as the manual referred to in point 7.1.1 of Annex II.

deleted

Amendment    143

Proposal for a regulation

Annex X – point 2 – introductory part

Text proposed by the Commission

Amendment

(2) The EU declaration of conformity shall contain the following elements:

deleted

Amendment    144

Proposal for a regulation

Annex X – point 2 – point a

Text proposed by the Commission

Amendment

(a) Subsystem/safety component model (product, batch, type or serial number).

(a) Subsystem/safety component or Subsystem/safety component model (product, type, batch or serial number).

Amendment    145

Proposal for a regulation

Annex X – point 2 – point e

Text proposed by the Commission

Amendment

(e) The object of the declaration described above is in conformity with the relevant Union harmonisation legislation: (reference to the other Union Acts applied):

(e) The object of the declaration described above is in conformity with the relevant Union harmonisation legislation

Amendment    146

Proposal for a regulation

Annex X – point 2 – point f

Text proposed by the Commission

Amendment

(f) References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared:

(f) References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared:

Amendment    147

Proposal for a regulation

Annex X – point 2 – point h

Text proposed by the Commission

Amendment

(h) identification of the person empowered to sign on behalf of the manufacturer or his authorised representative;.

deleted

EXPLANATORY STATEMENT

General observations

Your Rapporteur supports the proposal for a Regulation on cableway installations which is an example of Union harmonisation legislation. The proposal sets out to harmonise the conditions of placing on the market of subsystems and safety components for cable installations and to ensure the free movement of these products in the EU. All safety components and subsystems will have to be designed and manufactured in compliance with the essential requirements provided for by the Regulation. With regard to the cableway installations, the Regulation also foresees total harmonisation of the essential requirements to which they must comply. The Regulation shall repeal and replace Directive 2000/9/EC of 20 March 2000 relating to cableway installations designed to carry persons.

Legal instrument

Your Rapporteur is convinced that the change of legal instrument from a Directive to a Regulation is in line with the general political commitment to strive for better regulation and to simplify the regulatory environment. The change takes into account the need to ensure a uniform implementation throughout the Union. As the Regulation foresees total harmonisation, Member States are not allowed to impose more stringent or additional requirements in their national legislation. Member States will however remain competent to regulate other aspects relating to cable installations such as land-use, regional planning and environmental protection. The choice for a Regulation is welcome in this regard as it will avoid unnecessary transposition costs and impose clear and detailed rules which will become applicable in a uniform manner throughout the Union. Furthermore, opting for a Regulation avoids the risk of diverging transposition which can lead to different levels of safety protection and distort the internal market. In this regard your Rapporteur wishes to point out that the issue of diverging transposition was identified as problem in the implementation Report of Directive 2000/9/EC.

Consistency with the NLF

Your Rapporteur supports the alignment of the provisions to the goods package adopted in 2008 and in particular to the Decision EC 768/2008 on a common framework for the marketing of products. The framework set out by the NLF consists of provisions which are commonly used in EU product legislation. Your Rapporteur wishes to continue the work of this committee following the adoption of nine proposals which together form the "alignment package". In this regard the draft Report strives to respect, where possible, the wording that was agreed between co-legislators during the previous legislature. After careful analysis of the proposal and a comprehensive comparison with Directive 2014/29/EU on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels, your Rapporteur proposes several amendments aiming to improve the consistency of the text with the NLF.

Market surveillance

Originally, it was foreseen that the provisions on market surveillance for cableway installations would be addressed by the new Regulation on Market Surveillance (Proposal for a Regulation of 13 February 2013 (COM(2013) 75 final)). As this proposal will most likely not be adopted in time, specific rules on market surveillance had to be inserted. Your Rapporteur therefore supports the inclusion of a new Chapter IV on Union Market Surveillance, Control of Subsystems and Safety Components entering the Union market and Union Safeguard Procedure.

Scope of the proposal

Your Rapporteur welcomes the fact that the proposal addresses the issue concerning the scope of Directive 2000/9/EC relating to cableway installations. As established in the impact assessment, which was positively evaluated by Parliament's Ex-Ante Impact Assessment Unit, a majority of stakeholders identify enhanced legal clarity as a primary objective. In this regard the proposal foresees that it shall be applicable to cableway installations designed to transport persons and to subsystems and safety components for such installations (Article 2 para.1) and clearly lists the exclusions (Article 2 para. 2). In particular with regard to cableway installations designed for both transport and leisure purposes, the proposal brings clarity. The exclusion of cableway installations used for leisure purposes in fairgrounds or amusement parks shall not apply to cableway installations that are intended for a dual function. With regard to historical installations, which often have a high level of touristic interest, Member States should be able to ensure a high level of protection of health and safety through their national legislation.

Subsystems

Finally, your Rapporteur supports the alignment of the conformity assessment procedures available for subsystems with those already used for safety components. For your Rapporteur there is no valid reason to treat subsystems differently than safety components as divergent approaches could create market distortions and differences of treatment. The proposal keeps the conformity assessment procedures for safety components provided for by Directive 2000/9/EC Directive and introduces them for subsystems. The corresponding conformity assessment modules however are updated with the NLF Decision.

PROCEDURE

Title

Cableway installations

References

COM(2014)0187 – C7-0111/2014 – 2014/0107(COD)

Date submitted to Parliament

27.3.2014

 

 

 

Committee responsible

       Date announced in plenary

IMCO

2.4.2014

 

 

 

Committees asked for opinions

       Date announced in plenary

ITRE

2.4.2014

TRAN

2.4.2014

 

 

Not delivering opinions

       Date of decision

ITRE

22.7.2014

TRAN

16.7.2014

 

 

Rapporteurs

       Date appointed

Antonio López-Istúriz White

17.7.2014

 

 

 

Discussed in committee

3.12.2014

5.2.2015

16.3.2015

 

Date adopted

17.3.2015

 

 

 

Result of final vote

+:

–:

0:

35

1

2

Members present for the final vote

Dita Charanzová, Carlos Coelho, Sergio Gaetano Cofferati, Lara Comi, Anna Maria Corazza Bildt, Daniel Dalton, Dennis de Jong, Pascal Durand, Vicky Ford, Ildikó Gáll-Pelcz, Antanas Guoga, Robert Jarosław Iwaszkiewicz, Liisa Jaakonsaari, Antonio López-Istúriz White, Jiří Maštálka, Eva Paunova, Jiří Pospíšil, Virginie Rozière, Christel Schaldemose, Olga Sehnalová, Mylène Troszczynski, Anneleen Van Bossuyt, Marco Zullo

Substitutes present for the final vote

Lucy Anderson, Jussi Halla-aho, Kaja Kallas, Othmar Karas, Jens Nilsson, Julia Reda, Adam Szejnfeld, Lambert van Nistelrooij, Josef Weidenholzer, Kerstin Westphal

Substitutes under Rule 200(2) present for the final vote

José Blanco López, Andrea Bocskor, Roger Helmer, György Hölvényi, Emilian Pavel

Date tabled

25.3.2015
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