Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (Text with EEA relevance)

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter

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.

Article 2

Scope

This Regulation does not apply to the following:

(a) lifts covered by Directive 2014/33/EU;

(b) cableway installations that are categorised by Member States as historic, cultural or heritage installations, that entered into service before 1 January 1986 and that are still in operation, and that have not had any significant changes in design or construction, including subsystems and safety components specifically designed for them;

(c) installations intended for agricultural or forestry purposes;

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

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

(f) mining installations or other industrial on-site installations used for industrial activities;

(g) installations in which the users or their carriers are waterborne.

Article 3

Definitions

For the purposes of this Regulation the following definitions apply:

(1) ‘cableway installation’ means a whole on-site system, consisting of infrastructure and subsystems, which is designed, constructed, assembled and put into service with the objective of transporting persons, where the traction is provided by cables positioned along the line of travel;

(2) ‘subsystem’ means a system listed in Annex I, or a combination thereof, intended to be incorporated into a cableway installation;

(3) ‘infrastructure’ means a station structure or a structure along the line specifically designed for each cableway installation and constructed on-site, which takes into account the layout and the data of the system and which is needed for the construction and the operation of the cableway installation, including the foundations;

(4) ‘safety component’ means any component of equipment or any device intended to be incorporated into a subsystem or a cableway installation for the purpose of ensuring a safety function, the failure of which endangers the safety or health of passengers, operating personnel or third parties;

(5) ‘operability’ means all the technical provisions and measures which have an impact on design and construction and are necessary in order for the cableway installation to operate safely;

(6) ‘maintainability’ means all the technical provisions and measures which have an impact on design and construction and are necessary for maintenance, having been designed to ensure that the cableway installation operates safely;

(7) ‘cable car’ means a cableway installation where the carriers are suspended from and propelled by one or more cables;

(8) ‘drag lift’ means a cableway installation where passengers with appropriate equipment are towed along a prepared track;

(9) ‘funicular railway’ means a cableway installation in which the carriers are hauled by one or more ropes along a track that may lie on the ground or be supported by fixed structures;

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

(11) ‘placing on the market’ means the first making available of a subsystem or a safety component on the Union market;

(12) ‘entry into service’ means the initial operation of a cableway installation with the explicit object of transporting persons;

(13) ‘manufacturer’ means any natural or legal person who manufactures a subsystem or a safety component or who has such a subsystem or a safety component designed or manufactured, and markets that subsystem or safety component under his name or trade mark or incorporates it into a cableway installation;

(14) ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;

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

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

(17) ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor of a subsystem or a safety component;

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

(19) ‘harmonised standard’ means a harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;

(20) ‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;

(21) ‘national accreditation body’ means a national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;

(22) ‘conformity assessment’ means the process demonstrating whether the essential requirements of this Regulation relating to a subsystem or safety component have been fulfilled;

(23) ‘conformity assessment body’ means a body that performs conformity assessment activities relating to a subsystem or safety component, including calibration, testing, certification and inspection;

(24) ‘recall’ means any measure aimed at achieving the return of a subsystem or a safety component that has already been made available to the person responsible for the cableway installation;

(25) ‘withdrawal’ means any measure aimed at preventing a subsystem or a safety component in the supply chain from being made available on the market;

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

(27) ‘CE marking’ means a marking by which the manufacturer indicates that the subsystem or the safety component is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing.

Article 4

Making available on the market of subsystems and safety components

Subsystems and safety components shall only be made available on the market if they comply with this Regulation.

Article 5

Entry into service of cableway installations

Article 6

Essential requirements

The cableway installations and their infrastructure, subsystems and safety components shall meet the essential requirements set out in Annex II which apply to them.

Article 7

Free movement of subsystems and safety components

Member States shall not prohibit, restrict or impede the making available on the market of subsystems and safety components which comply with this Regulation.

Article 8

Safety analysis and safety report for planned cableway installations

The safety analysis required for each cableway installation shall:

(a) take into account all modes of operation envisaged;

(b) follow a recognised or established method;

(c) take into account the current state of the art and the complexity of the cableway installation in question;

(d) ensure that the design and configuration of the cableway installation takes account of the local surroundings and the most adverse situations in order to ensure satisfactory safety conditions;

(e) cover all safety aspects of the cableway installation and its external factors in the context of the design, construction and entry into service;

(f) make it possible to identify from past experience risks liable to occur during the operation of the cableway installation.

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

(a) 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) are redundant and are monitored; or

(c) are such that the probability of their failure can be evaluated and their effects are of a standard equivalent to that achieved by safety devices that meet the criteria set out in points (a) and (b).

Article 9

Authorisation of cableway installations

Article 10

Operation of cableway installations

CHAPTER II

OBLIGATIONS OF ECONOMIC OPERATORS

Article 11

Obligations of manufacturers

Where compliance of a subsystem or a safety component with the applicable requirements has been demonstrated by the procedure referred to in the first subparagraph, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.

When deemed appropriate with regard to the risks presented by a subsystem or a safety component, manufacturers shall, to protect the health and safety of 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 non-conforming subsystems and safety components and recalls of such subsystems and safety components, and shall keep distributors informed of any such monitoring.

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

However, where a large number of subsystems or safety components are delivered to a single economic operator or user, the batch or consignment concerned may be accompanied by a single copy of the EU declaration of conformity.

Article 12

Authorised representatives

The obligations laid down in Article 11(1) and the obligation to draw up technical documentation shall not form part of the authorised representative's mandate.

An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:

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

(b) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the subsystem or the safety component;

(c) cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by subsystems or safety components covered by the authorised representative's mandate.

Article 13

Obligations of importers

Where an importer considers or has reason to believe that a subsystem or a safety component is not in conformity with the applicable essential requirements set out in Annex II, he shall not place the subsystem or the safety component on the market until it has been brought into conformity. Furthermore, where the subsystem or the safety component presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect.

Where the importer indicates a website address, he shall ensure that the information on that website is accessible and kept updated.

Article 14

Obligations of distributors

Where a distributor considers or has reason to believe that a subsystem or a safety component is not in conformity with the applicable essential requirements set out in Annex II, he shall not make the subsystem or the safety component available on the market until it has been brought into conformity. Furthermore, where the subsystem or the safety component presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities.

Article 15

Cases in which obligations of manufacturers apply to importers and distributors

An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer under Article 11, where he places a subsystem or a safety component on the market under his name or trade mark or modifies a subsystem or a safety component already placed on the market in such a way that compliance with the requirements of this Regulation may be affected.

Article 16

Identification of economic operators

Economic operators shall, on request, identify the following to the market surveillance authorities:

(a) any economic operator who has supplied them with a subsystem or a safety component;

(b) any economic operator and any person responsible for a cableway installation to whom they have supplied a subsystem or a safety component.

Economic operators shall be able to present the information referred to in the first paragraph for 30 years after they have been supplied with the subsystem or the safety component and for 30 years after they have supplied the subsystem or the safety component.

CHAPTER III

CONFORMITY OF SUBSYSTEMS AND SAFETY COMPONENTS

Article 17

Presumption of conformity of subsystems and safety components

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.

Article 18

Conformity assessment procedures

The conformity of subsystems and safety components shall be assessed, at the choice of the manufacturer, by means of any of the following conformity assessment procedures:

(a) EU-type examination (Module B — production type), set out in Annex III combined with one of the following: (i) conformity to type based on quality assurance of the production process (Module D), set out in Annex IV; (ii) conformity to type based on subsystem or safety component verification (Module F), set out in Annex V;

(b) conformity based on unit verification (Module G), set out in Annex VI;

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

Article 19

EU declaration of conformity

Article 20

General principles of the CE marking

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

Article 21

Rules and conditions for affixing the CE marking

CHAPTER IV

NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Article 22

Notification

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

Article 23

Notifying authorities

Article 24

Requirements relating to notifying authorities

Article 25

Information obligation on notifying authorities

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

The Commission shall make that information publicly available.

Article 26

Requirements relating to notified bodies

A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of subsystems or safety components which it assesses, may, on the condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.

A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, marketing, installation, use or maintenance of those subsystems or safety components, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.

Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

At all times, and for each conformity assessment procedure and each kind or category of subsystems or safety components in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:

(a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;

(b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;

(c) procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the subsystem or safety component technology in question and the mass or serial nature of the production process.

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

The personnel responsible for carrying out conformity assessment tasks shall have the following:

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

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

(c) appropriate knowledge and understanding of the essential requirements set out in Annex II, of the applicable harmonised standards and of the relevant provisions of Union harmonisation legislation and of national legislation;

(d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

The remuneration of the top-level management and of the personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out, nor on the results of those assessments.

Article 27