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Regulation (EU) 2016/424 of the European Parliament and of the CouncilDangos y teitl llawn

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)

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Changes over time for: Regulation (EU) 2016/424 of the European Parliament and of the Council (without Annexes)

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CHAPTER IU.K.GENERAL PROVISIONS

Article 1U.K.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 2U.K.Scope

1.This Regulation applies to new cableway installations designed to transport persons, to modifications of cableway installations requiring a new authorisation, and to subsystems and safety components for cableway installations.

2.This Regulation does not apply to the following:

(a)lifts covered by [F1the Lifts Regulations 2016];

(b)cableway installations that are categorised [F2by the Cableway Installations Regulations 2018] 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.

Textual Amendments

Article 3U.K.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 F3... 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 F4... 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 F5... 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 [F6established within the United Kingdom] who places a subsystem or a safety component from a third country on the [F7market];

(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)

F8...

(20)

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

(21)

F9...

(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)

F10...

(27)

F11...

(28)

[F12‘the EU Regulation’ means 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 as that Regulation has effect in EU law as amended from time to time;

(29)

‘the Executive’ means—

(a)

in Great Britain, the Health and Safety Executive,

(b)

in Northern Ireland, the Health and Safety Executive for Northern Ireland;

(30)

‘designated standard’ has the meaning given by article 3A;

(31)

‘RAMS’ means Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93;

(32)

‘UK marking’ means marking in the form published in accordance with Article 30(1) of RAMS.]

Textual Amendments

[F13Article 3AU.K. Designated Standards

1.For the purposes of this Regulation, a designated standard is a technical standard—

(a)which is adopted by the British Standards Institution [F14or an international standardising body] for repeated or continuous application; and

(b)which has been designated by the Secretary of State by publishing its reference number in a manner the Secretary of State considers appropriate.

2.In this Article, a “technical standard” means a document that prescribes technical requirements to be fulfilled by a cableway installation, infrastructure, subsystem or safety component and which lays down one or more of the following—

(a)the characteristics required including—

(i)levels of quality, performance, interoperability, environmental protection, health, safety or dimensions, and

(ii)requirements applicable as regards the name under which a product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures;

(b)production methods and processes where these have an effect on the characteristics of a product.

[F152A.Before publishing the reference number of a technical standard adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical standard is consistent with any standards adopted by international standardising bodies which the Secretary of State considers to be relevant.]

3.When considering whether the manner of publication of the reference number of a technical standard under paragraph 1(b) is appropriate, the Secretary of State must have regard to whether that manner will draw sufficient attention to the standard to all persons who may have an interest in it.

4.The Secretary of State may remove the reference number of a technical standard from publication and where such a reference number is removed, the technical standard is no longer a designated standard.

5.Harmonised standards, within the meaning of Article 3(19) of the EU Regulation, have effect as designated standards until the Secretary of State designates standards under this Regulation.

[F166.In this Article “international standardising body” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time).]]

Textual Amendments

Article 4U.K.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.

[F17Article 5U.K.Presumption of conformity of cableway installations

Cableway installations which are in conformity with designated standards, or parts thereof, are presumed to be in conformity with the essential requirements set out in Annex 2 covered by those standards or parts thereof.]

Textual Amendments

Article 6U.K.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.

F18Article 7U.K.Free movement of subsystems and safety components

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Textual Amendments

Article 8U.K.Safety analysis and safety report for planned cableway installations

1.The person responsible for the cableway installationF19... shall carry out a safety analysis of the planned cableway installation or have such a safety analysis carried out.

2.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.

3.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).

4.The 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.

5.The result of the safety analysis shall be included in a safety report.

Textual Amendments

Article 9U.K.Authorisation of cableway installations

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2.The person responsible for the cableway installationF21... shall submit the safety report referred to in Article 8, the [F22declaration] 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 authorising the cableway installation. The documentation concerning the cableway installation shall also include the necessary conditions, including the restrictions on operation, and full details for servicing, supervision, adjustment and maintenance of the cableway installation. A copy of those documents shall be kept at the cableway installation.

3.In the event that important characteristics, subsystems or safety components of existing cableway installations undergo modifications for which a new authorisation for entry into service is required by the [F23Secretary of State], such modifications and their repercussions on the cableway installation as a whole shall satisfy the essential requirements set out in Annex II.

F244.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F255.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F26Article 10U.K.Operation of cableway installations

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Textual Amendments

CHAPTER IIU.K. OBLIGATIONS OF ECONOMIC OPERATORS

Article 11U.K.Obligations of manufacturers

1.When placing their subsystems or safety components on the market or when incorporating them into a cableway installation, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential requirements set out in Annex II.

2.Manufacturers of subsystems or safety components shall draw up the technical documentation set out in Annex VIII (‘technical documentation’) and carry out the relevant conformity assessment procedure referred to in Article 18 or have it carried out.

Where compliance of a subsystem or a safety component with the applicable requirements has been demonstrated by the procedure referred to in the first subparagraph, manufacturers shall draw up [F27a declaration of conformity] and affix the [F28UK marking].

3.Manufacturers shall keep the technical documentation and [F29the declaration of conformity] for 30 years after the subsystem or the safety component has been placed on the market.

4.Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Regulation. Changes in subsystem or safety component design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which the conformity of the subsystem or the safety component is declared shall be adequately taken into account.

When deemed appropriate with regard to the risks presented by a subsystem or a safety component, manufacturers shall, to protect the health and safety of 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.

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

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.

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 or in a document accompanying the subsystem or safety component. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in [F30English]. Where the manufacturer indicates a website address, he shall ensure that the information on that website is accessible and kept updated.

7.Manufacturers shall ensure that the subsystem or the safety component is accompanied by a copy of [F29the declaration of conformity] and by instructions and safety information, in [F31English]. Such instructions and safety information shall be clear, understandable and intelligible.

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 [F29the declaration of conformity].

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 [F32Executive] to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

9.Manufacturers shall, further to a reasoned request from [F33the Executive], provide it with all the information and documentation necessary to demonstrate the conformity of the subsystem or the safety component with this Regulation, in [F34English]. 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.

Textual Amendments

Article 12U.K.Authorised representatives

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

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

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

(a)keep the [F35declaration] of conformity and the technical documentation at the disposal of [F36the Executive] for 30 years after the subsystem or the safety component has been placed on the market;

(b)further to a reasoned request from [F37the Secretary of State], 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 [F38Secretary of State, at the Secretary of State's] request, on any action taken to eliminate the risks posed by subsystems or safety components covered by the authorised representative's mandate.

Textual Amendments

Article 13U.K.Obligations of importers

1.Importers shall place only compliant subsystems or safety components on the market.

2.Before placing on the market a subsystem or a safety component, importers shall ensure that the appropriate conformity assessment procedure 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 bears the [F39UK marking] and that it is accompanied by a copy of the [F40declaration] of conformity, by instructions and safety information, and, where appropriate, by other required documents, and that the manufacturer has complied with the requirements set out in Article 11(5) and (6).

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 [F41Executive] to that effect.

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 or, where that is not possible, on its packaging or in a document accompanying the subsystem or safety component. The contact details shall be in [F42English].

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

4.Importers shall ensure that the subsystem or the safety component is accompanied by instructions and safety information, [F43in English].

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

6.When deemed appropriate with regard to the risks presented by a subsystem or a safety component, importers shall, to protect the health and safety of the 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.

7.Importers who consider or have reason to believe that a subsystem or a safety component which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that subsystem or safety component into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the subsystem or the safety component presents a risk, importers shall immediately inform the [F44Secretary of State] to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

8.Importers shall, for 30 years after the subsystem or the safety component has been placed on the market, keep a copy of the [F45declaration] of conformity at the disposal of the [F46Executive] and ensure that the technical documentation can be made available to [F47the Executive], upon request.

9.Importers shall, further to a reasoned request from [F48the Secretary of State, provide the Secretary of State] with all the information and documentation necessary to demonstrate the conformity of a subsystem or a safety component, in [F49English]. 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.

Textual Amendments

Article 14U.K.Obligations of distributors

1.When making a subsystem or a safety component available on the market, distributors shall act with due care in relation to the requirements of this Regulation.

2.Before making a subsystem or a safety component available on the market, distributors shall verify that the subsystem or the safety component bears the [F50UK marking] and that it is accompanied by a copy of the [F51declaration] of conformity, by instructions and safety information, and, where appropriate, by other required documents, [F52in English] and that the manufacturer and the importer have complied with the requirements set out in Article 11(5) and (6) and Article 13(3) respectively.

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 [F53Executive].

3.Distributors shall ensure that, while a subsystem or a safety component is under their responsibility, storage or transport conditions do not jeopardise its compliance with the applicable essential requirements set out in Annex II.

4.Distributors who consider or have reason to believe that a subsystem or a safety component which they have made available on the market is not in conformity with this Regulation shall make sure that the corrective measures necessary to bring that subsystem or safety component into conformity, to withdraw it or recall it, if appropriate, are taken. Furthermore, where the subsystem or the safety component presents a risk, distributors shall immediately inform the [F54Secretary of State] to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

5.Distributors shall, further to a reasoned request from [F55the Secretary of State, provide the Secretary of State] 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 [F56the Secretary of State, at the Secretary of State's] request, on any action taken to eliminate the risks posed by subsystems or safety components which they have made available on the market.

Textual Amendments

Article 15U.K.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 16U.K.Identification of economic operators

Economic operators shall, on request, identify the following to the [F57Executive]:

(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.

Textual Amendments

CHAPTER IIIU.K. CONFORMITY OF SUBSYSTEMS AND SAFETY COMPONENTS

Article 17U.K.Presumption of conformity of subsystems and safety components

Subsystems and safety components which are in conformity with [F58designated standards] shall be presumed to be in conformity with the essential requirements set out in Annex II covered by those standards or parts thereof.

Textual Amendments

Article 18U.K.Conformity assessment procedures

1.Before a subsystem or a safety component is placed on the market, the manufacturer shall submit the subsystem or the safety component to a conformity assessment procedure in accordance with paragraph 2.

2.The 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)[F59Type] 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.

3.Records and correspondence relating to the conformity assessment procedures shall be drawn up in [F60English].

Textual Amendments

Article 19U.K.[F61Declaration] of conformity

1.The [F62declaration] of conformity for a subsystem or a safety component shall state that the fulfilment of the essential requirements set out in Annex II has been demonstrated.

2.The [F62declaration] of conformity shall have the model structure set out in Annex IX, shall contain the elements specified in the relevant modules set out in Annexes III to VII and shall be continuously updated. It shall accompany the subsystem or the safety component [F63and be in English].

[F643.Where a subsystem or a safety component is subject to more than one enactment requiring a declaration of conformity, a single declaration of conformity must be drawn up in respect of all such enactments. That declaration must contain the identification of the enactments concerned.]

4.By drawing up the [F62declaration] of conformity, the manufacturer shall assume responsibility for the compliance of the subsystem or the safety component with the requirements laid down in this Regulation.

Textual Amendments

[F65Article 20U.K.Requirements of the UK marking

The UK marking is subject to the requirements set out in Article 30 of, and Annex 2 to, Regulation (EC) No 765/2008.]

Textual Amendments

Article 21U.K.Rules and conditions for affixing the [F66UK marking]

1.The [F67UK marking] shall be affixed visibly, legibly and indelibly to the subsystem or the safety component or to its 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.

2.The [F67UK marking] shall be affixed before the subsystem or the safety component is placed on the market.

3.The [F67UK 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.

4.The [F67UK marking] and the identification number referred to in paragraph 3 may be followed by any other mark indicating a special risk or use.

F685.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

CHAPTER IVU.K.NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

[F69Article 22U.K.Approval

1.The Secretary of State may approve bodies to carry out third-party conformity assessment tasks under this Regulation.

2.The Secretary of State must—

(a)assign an approved body identification number to each approved body;

(b)compile and maintain a register of approved bodies containing in relation to each body—

(i)the approved body identification number,

(ii)details of the activities for which the body is approved, and

(iii)any restrictions on the activities for which the body is approved.

3.The register referred to in paragraph 2 must be made publicly available.]

Textual Amendments

F70Article 23U.K.Notifying authorities

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Textual Amendments

F70Article 24U.K.Requirements relating to notifying authorities

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Textual Amendments

F70Article 25U.K.Information obligation on notifying authorities

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Textual Amendments

Article 26U.K.Requirements relating to [F71approved] bodies

1.For the purposes of [F72approval], a conformity assessment body shall meet the requirements laid down in [F73paragraphs 3 to 10].

F742.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.A conformity assessment body shall be a third-party body independent of the organisation or the subsystem or the safety component it assesses.

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

4.A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the subsystems or the safety components which they assess, nor the representative of any of those parties. This shall not preclude the use of assessed subsystems or safety components that are necessary for the operations of the conformity assessment body or the use of such subsystems or safety components for personal purposes.

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

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

5.Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.

6.A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Annexes III to VII and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.

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

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

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

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

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

7.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 [F75designated standards and of the relevant provisions of this Regulation and of the Cableway Installations Regulations 2018];

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

8.The impartiality of the conformity assessment bodies, their top-level management and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed.

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

9.Conformity assessment bodies shall take out liability insurance F76....

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 III to VII F77..., except in relation to the [F78Secretary of State or the Executive]. Proprietary rights shall be protected.

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Textual Amendments

Article 27U.K.Presumption of conformity of notified bodies

[F801.]Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 26 in so far as the applicable harmonised standards cover those requirements.

[F812.In paragraph 1, expressions used are to be given the same meaning as in the EU Regulation.]

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Article 28U.K.Subsidiaries of and subcontracting by [F82approved] bodies

1.Where [F83an approved] body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 26 and shall inform the [F84Secretary of State] accordingly.

2.[F85Approved] bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.

3.Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.

4.[F86Approved] bodies shall keep at the disposal of the [F87Secretary of State] the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annexes III to VII.

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Article 29U.K.Application for [F88approval]

1.A conformity assessment body shall submit an application for [F89approval] to the [F90Secretary of State].

2.The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the subsystem/safety component or subsystems/safety components for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by [F91the United Kingdom Accreditation Service] attesting that the conformity assessment body fulfils the requirements laid down in Article 26.

3.Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 26.

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F92Article 30U.K.Notification procedure

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F93Article 31U.K.Identification numbers and lists of notified bodies

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Article 32U.K.Changes to [F94approvals]

1.Where [F95the Secretary of State] has ascertained or has been informed that [F96an approved] body no longer meets the requirements laid down in Article 26 or that it is failing to fulfil its obligations, [F97the Secretary of State] shall restrict, suspend or withdraw the [F98approval], as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. F99...

2.In the event of restriction, suspension or withdrawal of notification, or where [F100the approved] body has ceased its activity, the [F101Secretary of State] shall take appropriate steps to ensure that the files of that body are either processed by [F102another approved] body or kept available for the [F103Secretary of State and the Executive] at their request.

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F104Article 33U.K.Challenge of the competence of notified bodies

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Article 34U.K.Operational obligations of [F105approved bodies]

1.[F106Approved bodies] shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Annexes III to VII.

2.Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators.

Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the subsystem or safety component technology in question and the mass or serial nature of the production process.

In so doing, they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the subsystem or the safety component with this Regulation.

3.Where [F107an approved body] finds that the essential requirements set out in Annex II or [F108corresponding designated 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 or approval decision.

4.Where, in the course of the monitoring of conformity following the issue of a certificate or approval decision, [F109an approved body] finds that a subsystem or a safety component no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate or the approval decision if necessary.

5.Where corrective measures are not taken or do not have the required effect, [F110the approved body] shall restrict, suspend or withdraw any certificates or approval decisions, as appropriate.

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Article 35U.K.Appeal against decisions of [F111approved] bodies

[F112Approved] bodies shall ensure that an appeal procedure against their decisions is available.

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Article 36U.K.Information obligation on [F113approved bodies]

1.[F114Approved bodies] shall inform the [F115Secretary of State] of the following:

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

(b)any circumstances affecting the scope of or the conditions for [F116approval];

(c)any request for information which they have received from [F117the Executive] regarding conformity assessment activities;

(d)on request, conformity assessment activities performed within the scope of their [F118approval] and any other activity performed, including cross-border activities and subcontracting.

2.[F119Approved bodies] shall provide the other bodies [F120approved under] this Regulation carrying out similar conformity assessment activities covering the same subsystems or safety components with relevant information on issues relating to negative and, on request, positive conformity assessment results.

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F121Article 37U.K.Exchange of experience

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F122Article 38U.K.Coordination of notified bodies

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CHAPTER VU.K.F123... MARKET SURVEILLANCE, CONTROL OF SUBSYSTEMS AND SAFETY COMPONENTS ENTERING THE F123... MARKET AND F123... SAFEGUARD PROCEDURE

Article 39U.K.F124... Market surveillance and control of subsystems and safety components entering the F124... market

Article 15(3) and [F125Articles 16 to 21] of Regulation (EC) No 765/2008 shall apply to subsystems and safety components.

Textual Amendments

Article 40U.K.Procedure F126... for dealing with subsystems or safety components presenting a risk

1.Where the [F127Executive has] sufficient reason to believe that a subsystem or safety component covered by this Regulation presents a risk to the health or safety of persons or to property, 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 [F128Executive] for that purpose.

Where, in the course of the evaluation referred to in the first subparagraph, the [F129Executive finds] that the subsystem or safety component does not comply with the requirements laid down in this Regulation, [F130it 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 [F131it may] prescribe.

The [F132Executive] shall inform the relevant [F133approved body] accordingly.

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

F1342.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 F135....

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F1368.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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F137Article 41U.K.Union safeguard procedure

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Article 42U.K.Compliant subsystems or safety components which present a risk

1.Where, having carried out an evaluation under Article 40(1), [F138the Executive] 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 or to property, [F139the Executive must 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 F140....

F1413.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F1414.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Textual Amendments

Article 43U.K.Formal non-compliance

1.Without prejudice to Article 40, where [F142the Executive] makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:

(a)the [F143UK marking] has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 21 of this Regulation;

(b)the [F144UK marking] has not been affixed;

(c)the identification number of the [F145approved] body involved in the production control phase has been affixed in violation of Article 21 or has not been affixed;

(d)the [F146declaration] of conformity does not accompany the subsystem or safety component;

(e)the [F147declaration] of conformity has not been drawn up;

(f)the [F148declaration] 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.

F1492.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Textual Amendments

CHAPTER VIU.K.COMMITTEE PROCEDURE, TRANSITIONAL AND FINAL PROVISIONS

F150Article 44U.K.Committee procedure

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F150Article 45U.K.Penalties

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F150Article 46U.K.Transitional provisions

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[F151Article 46AU.K.Post-withdrawal continuity provision

1.Paragraph 2 applies where, at any time before any technical standard has been adopted and designated as a designated standard in accordance with Article 3A—

(a)a subsystem or safety component has been assessed by a notified body in accordance with any of the EU conformity assessment procedures;

(b)an EU declaration of conformity has been drawn up in accordance with the EU Regulation in respect of that subsystem or safety component; and

(c)a CE marking has been affixed to that subsystem or safety component in accordance with the EU Regulation.

2.Where this paragraph applies—

(a)a subsystem or safety component is to be treated as having been assessed in accordance with the equivalent conformity assessment procedure in Chapter 3 of this Regulation; and

(b)the EU declaration of conformity and the CE marking are to be treated for the purposes of this Regulation and any other enactment relating to cableway installations as if they were respectively a declaration of conformity under this Regulation and a UK marking.

3.In this Article—

(a)“CE marking” has the same meaning as in Article 3(27) of the EU Regulation;

(b)“EU conformity assessment procedures” means the procedures provided for under Article 18(2) of the EU Regulation;

(c)“EU declaration of conformity” has the same meaning as in the EU Regulation;

(d)“notified body” means a body notified to the Commission under Article 22 of the EU Regulation.]

Textual Amendments

Article 47U.K.Repeal

Directive 2000/9/EC is repealed with effect from 21 April 2018.

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

Article 48U.K.Entry into force and application

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

2.This Regulation shall apply from 21 April 2018, with the exception of:

(a)Articles 22 to 38 and 44, which shall apply from 21 October 2016;

(b)Article 45(1), which shall apply from 21 March 2018.

F152...

Textual Amendments

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