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Commission Implementing Regulation (EU) No 402/2013Show full title

Commission Implementing Regulation (EU) No 402/2013 of 30 April 2013 on the common safety method for risk evaluation and assessment and repealing Regulation (EC) No 352/2009 (Text with EEA relevance)

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Changes over time for: Commission Implementing Regulation (EU) No 402/2013 (without Annexes)

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F1Article 1U.K.Subject matter

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 2E+W+SScope

1.This Regulation shall apply to the proposer as defined in Article 3(11) when making any change to the railway system in [F2Great Britain].

Such changes may be of a technical, operational or organisational nature. As regards organisational changes, only those changes which could impact the operational or maintenance processes shall be subjected to consideration under the rules of Article 4.

2.When, on the basis of an assessment under the criteria set out in Article 4(2)(a) to (f):

(a)the change is considered significant, the risk management process set out in Article 5 shall be applied;

(b)the change is considered not significant, keeping adequate documentation to justify the decision shall be sufficient.

3.This Regulation shall apply also to structural sub-systems to which [F3the Railways (Interoperability) Regulations 2011 apply]:

F4(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)if the change is significant as set out in Article 4(2), the risk management process set out in Article 5 shall be applied within the placing in service of structural sub-systems to ensure their safe integration into an existing systemF5....

4.The application of this Regulation in the case referred to in paragraph 3(b) of this Article shall not lead to requirements contradictory to those laid down in the relevant [F6NTSNs]. [F7If such contradictions occur, the proposer shall inform the Secretary of State who may then decide to publish a variation of the NTSN in accordance with paragraphs (3) and (4) of regulation 3B of the Railways (Interoperability) Regulations 2011 or issue an exemption in accordance with regulation 14 of those Regulations.]

F85.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F96.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Article 2N.I.Scope

1.This Regulation shall apply to the proposer as defined in Article 3(11) when making any change to the railway system in [F62Northern Ireland].

Such changes may be of a technical, operational or organisational nature. As regards organisational changes, only those changes which could impact the operational or maintenance processes shall be subjected to consideration under the rules of Article 4.

2.When, on the basis of an assessment under the criteria set out in Article 4(2)(a) to (f):

(a)the change is considered significant, the risk management process set out in Article 5 shall be applied;

(b)the change is considered not significant, keeping adequate documentation to justify the decision shall be sufficient.

3.This Regulation shall apply also to structural sub-systems to which [F63the Railways (Interoperability) Regulations 2011 apply]:

F64(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)if the change is significant as set out in Article 4(2), the risk management process set out in Article 5 shall be applied within the placing in service of structural sub-systems to ensure their safe integration into an existing systemF65....

4.The application of this Regulation in the case referred to in paragraph 3(b) of this Article shall not lead to requirements contradictory to those laid down in the relevant [F66NTSNs]. [F67If such contradictions occur, the proposer shall inform the Secretary of State, who may then decide to publish a variation of the NTSN in accordance with paragraphs (3) and (4) of regulation 3B of the Railways (Interoperability) Regulations 2011, and the Department for Infrastructure, who may then decide to issue an exemption in accordance with regulation 14 of those Regulations.]

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

F696.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E7This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

[F10Article 3E+W+SDefinitions

For the purposes of this Regulation the following definitions shall apply.

  • ‘accident’ means an unwanted or unintended sudden event or a specific chain of such events which have harmful consequences; accidents are divided into the following categories: collisions, derailments, level-crossing accidents, accidents to persons caused by rolling stock in motion, fires and others;

  • ‘accreditation’ means an attestation by a national accreditation body that a conformity assessment body meets the requirements set by designated standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity;

  • ‘actors’ means all parties which are, directly or through contractual arrangements, involved in the application of this Regulation;

  • ‘approved body’ has the meaning provided in regulation 2 of the Railways (Interoperability) Regulations 2011;

  • ‘assessment body’ means the independent and competent external or internal individual, organisation or entity which undertakes investigation to provide a judgement, based on evidence, of the suitability of a system to fulfil its safety requirements;

  • ‘barrier’ means a technical, operational or organisational risk control measure outside the system under assessment that either reduces the frequency of occurrence of a hazard or mitigates the severity of the potential consequence of that hazard;

  • ‘catastrophic accident’ means an accident typically affecting a large number of people and resulting in multiple fatalities;

  • ‘certification body’ has the meaning provided in regulation 2 of the Railways and Other Guided Transport (Safety) Regulations 2006;

  • ‘code of practice’ means a written set of rules that, when correctly applied, can be used to control one or more specific hazards;

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

  • ‘critical accident’ means an accident typically affecting a very small number of people and resulting in at least one fatality;

  • ‘designated body’ has the meaning provided in regulation 2 of the Railways (Interoperability) Regulations 2011;

  • ‘designated standard’ has the meaning provided in Article 3A;

  • ‘entity in charge of maintenance’ means an entity in charge of maintenance of a vehicle, and registered as such in the National Vehicle Register;

  • ‘EU notified body’ has the meaning provided in regulation 2 of the Railways (Interoperability) Regulations 2011;

  • ‘hazard’ means a condition that could lead to an accident;

  • ‘hazard identification’ means the process of finding, listing and characterising hazards;

  • ‘hazard record’ means the document in which identified hazards, their related measures, their origin and the reference to the organisation which has to manage them are recorded and referenced;

  • ‘highly improbable’ means an occurrence of failure at a frequency less than or equal to 10-9 per operating hour;

  • ‘improbable’ means an occurrence of failure at a frequency less than or equal to 10-7 per operating hour.

  • ‘incident’ means any occurrence, other than an accident, associated with the operation of trains and affecting the safety of operation;

  • ‘infrastructure manager’ means any body or undertaking that is responsible in particular for establishing and maintaining railway infrastructure, or a part thereof, as defined in Article 3 of Directive 91/440/EEC, which may also include the management of infrastructure control and safety systems. The functions of the infrastructure manager on a network or part of a network may be allocated to different bodies or undertakings;

  • ‘interfaces’ means all points of interaction during a system or subsystem life cycle, including operation and maintenance where different actors of the rail sector will work together in order to manage the risks;

  • ‘investigation’ means a process conducted for the purpose of accident and incident prevention which includes the gathering and analysis of information, the drawing of conclusions, including the determination of causes and, when appropriate, the making of safety recommendations;

  • ‘national accreditation body’ means the sole body in the United Kingdom that performs accreditation in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9th July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93;

  • ‘national rule’ means NTRs as defined in regulation 2 of the Railways (Interoperability) Regulations 2011 and national safety rules as defined in regulation 2 of the Railways and Other Guided Transport Systems (Safety) Regulations 2006;

  • ‘NTSN’ has the meaning provided in regulation 2 of the Railways (Interoperability) Regulations 2011;

  • ‘national safety authority’ means one or both of—

    (a)

    a safety authority; and

    (b)

    the safety authority for the tunnel system; as defined in the Railways and Other Guided Transport Systems (Safety) Regulations 2006;

  • ‘proposer’ means one of the following—

    (a)

    a railway undertaking or an infrastructure manager;

    (b)

    an entity in charge of maintenance;

    (c)

    a contracting entity or manufacturer which invites—

    (i)

    an approved body or a designated body to apply the UK verification assessment procedure in accordance with regulation 17 of and Schedule 4 to the Railways (Interoperability) Regulations 2011; or

    (ii)

    an EU notified body to apply the EC verification procedure in accordance with Directive 2008/57/EC or a designated body according to Article 17(3) of that Directive;

  • ‘railway system’ means the totality of the subsystems in Great Britain for structural and operational areas, as defined in paragraph 2(1) to 2(7) of Annex II to Directive 2008/57/EC, as well as the management and operation of the system as a whole;

  • ‘railway undertaking’ means a public or private undertaking, licensed according to applicable legislation, the activity of which is to provide transport of goods and/or passengers by rail on the basis that the undertaking must ensure traction; this also includes undertakings which provide traction only;

  • ‘recognition’ means an attestation by a national body other than the national accreditation body that the assessment body meets the requirements set out in Annex II to this Regulation to carry out the independent assessment activity specified in Article 6(1) and (2);

  • ‘reference system’ means a system proven in use to have an acceptable safety level and against which the acceptability of the risks from a system under assessment can be evaluated by comparison;

  • ‘risk’ means the frequency of occurrence of accidents and incidents resulting in harm caused by a hazard and the degree of severity of that harm;

  • ‘risk acceptance criteria’ means the terms of reference by which the acceptability of a specific risk is assessed; these criteria are used to determine that the level of a risk is sufficiently low that it is not necessary to take any immediate action to reduce it further;

  • ‘risk acceptance principle’ means the rules used in order to arrive at the conclusion whether or not the risk related to one or more specific hazards is acceptable;

  • ‘risk analysis’ means systematic use of all available information to identify hazards and to estimate the risk;

  • ‘risk assessment’ means the overall process comprising a risk analysis and a risk evaluation;

  • ‘risk estimation’ means the process used to produce a measure of the level of risks being analysed, consisting of the following steps: estimation of frequency, consequence analysis and their integration;

  • ‘risk evaluation’ means a procedure based on the risk analysis to determine whether an acceptable level of risk has been achieved;

  • ‘risk management’ means the systematic application of management policies, procedures and practices to the tasks of analysing, evaluating and controlling risks;

  • ‘safety’ means freedom from unacceptable risk of harm;

  • ‘safety acceptance’ means the status given to the change by the proposer based on the safety assessment report provided by the assessment body;

  • ‘safety assessment report’ means the document containing the conclusions of the assessment performed by an assessment body on the system under assessment;

  • ‘safety management system’ means the organisation and arrangements established by an infrastructure manager or a railway undertaking to ensure the safe management of its operations;

  • ‘safety measures’ means a set of actions either reducing the frequency of occurrence of a hazard or mitigating its consequences in order to achieve and/or maintain an acceptable level of risk;

  • ‘safety requirements’ means the safety characteristics (qualitative or quantitative, or when needed both qualitative and quantitative) necessary for the design, operation (including operational rules) and maintenance of a system in order to meet legal or company safety targets;

  • ‘system’ means any part of the railway system which is subjected to a change whereby the change may be of a technical, operational or organisational nature;

  • ‘systematic failure’ means a failure that occurs repeatedly under some particular combination of inputs or under some particular environmental or application conditions;

  • ‘systematic fault’ means an inherent fault in the specification, design, manufacturing, installation, operation or maintenance of the system under assessment;

  • ‘technical system’ means a product or an assembly of products including the design, implementation and support documentation; the development of a technical system starts with its requirements specification and ends with its acceptance; although the design of relevant interfaces with human behaviour is considered, human operators and their actions are not included in a technical system; the maintenance process is described in the maintenance manuals but is not itself part of the technical system;

  • ‘vehicle’ means a railway vehicle suitable for circulation on its own wheels on railway lines, with or without traction. A vehicle is composed of one or more structural and functional subsystems or parts of such subsystems.]

Extent Information

E2This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

[F70Article 3N.I.Definitions

For the purposes of this Regulation the following definitions shall apply.

  • ‘accident’ means an unwanted or unintended sudden event or a specific chain of such events which have harmful consequences; accidents are divided into the following categories: collisions, derailments, level-crossing accidents, accidents to persons caused by rolling stock in motion, fires and others;

  • ‘accreditation’ means an attestation by a national accreditation body that a conformity assessment body meets the requirements set by designated standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity;

  • ‘actors’ means all parties which are, directly or through contractual arrangements, involved in the application of this Regulation;

  • ‘approved body’ has the meaning provided in regulation 2 of the Railways (Interoperability) Regulations 2011;

  • ‘assessment body’ means the independent and competent external or internal individual, organisation or entity which undertakes investigation to provide a judgement, based on evidence, of the suitability of a system to fulfil its safety requirements;

  • ‘barrier’ means a technical, operational or organisational risk control measure outside the system under assessment that either reduces the frequency of occurrence of a hazard or mitigates the severity of the potential consequence of that hazard;

  • ‘catastrophic accident’ means an accident typically affecting a large number of people and resulting in multiple fatalities;

  • ‘code of practice’ means a written set of rules that, when correctly applied, can be used to control one or more specific hazards;

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

  • ‘critical accident’ means an accident typically affecting a very small number of people and resulting in at least one fatality;

  • ‘designated body’ has the meaning provided in regulation 2 of the Railways (Interoperability) Regulations 2011;

  • ‘designated standard’ has the meaning provided in Article 3A;

  • ‘entity in charge of maintenance’ means an entity in charge of maintenance of a vehicle, and registered as such in the National Vehicle Register;

  • ‘EU notified body’ has the meaning provided in regulation 2 of the Railways (Interoperability) Regulations 2011;

  • ‘hazard’ means a condition that could lead to an accident;

  • ‘hazard identification’ means the process of finding, listing and characterising hazards;

  • ‘hazard record’ means the document in which identified hazards, their related measures, their origin and the reference to the organisation which has to manage them are recorded and referenced;

  • ‘highly improbable’ means an occurrence of failure at a frequency less than or equal to 10-9 per operating hour;

  • ‘improbable’ means an occurrence of failure at a frequency less than or equal to 10-7 per operating hour;

  • ‘incident’ means any occurrence, other than accident, associated with the operation of trains and affecting the safety of operation;

  • ‘infrastructure manager’ means any body or undertaking that is responsible in particular for establishing and maintaining railway infrastructure, or a part thereof, as defined in Article 3 of Directive 91/440/EEC, which may also include the management of infrastructure control and safety systems. The functions of the infrastructure manager on a network or part of a network may be allocated to different bodies or undertakings;

  • ‘interfaces’ means all points of interaction during a system or subsystem life cycle, including operation and maintenance where different actors of the rail sector will work together in order to manage the risks;

  • ‘investigation’ means a process conducted for the purpose of accident and incident prevention which includes the gathering and analysis of information, the drawing of conclusions, including the determination of causes and, when appropriate, the making of safety recommendations;

  • ‘national accreditation body’ means the sole body in the United Kingdom that performs accreditation in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9th July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93;

  • ‘national rule’ means NTRs as defined in regulation 2 of the Railways (Interoperability) Regulations 2011 and national safety rules as defined in regulation 2 of the Railways (Safety Management) Regulations (Northern Ireland) 2006;

  • ‘national safety authority’ has the meaning provided for “safety authority” in the Railways (Safety Management) Regulations (Northern Ireland) 2006;

  • ‘proposer’ means one of the following—

    (a)

    a railway undertaking or an infrastructure manager;

    (b)

    an entity in charge of maintenance;

    (c)

    a contracting entity or manufacturer which invites—

    (i)

    an approved body or a designated body to apply the UK verification assessment procedure in accordance with regulation 17 of and Schedule 4 to the Railways (Interoperability) Regulations 2011; or

    (ii)

    an EU notified body to apply the EC verification procedure in accordance with Directive 2008/57/EC or a designated body according to Article 17(3) of that Directive;

  • ‘railway system’ means the totality of the subsystems in Northern Ireland for structural and operational areas, as defined in paragraph 2(1) to 2(7) of Annex II to Directive 2008/57/EC, as well as the management and operation of the system as a whole;

  • ‘railway undertaking’ means a public or private undertaking, licensed according to applicable legislation, the activity of which is to provide transport of goods and/or passengers by rail on the basis that the undertaking must ensure traction; this also includes undertakings which provide traction only;

  • ‘recognition’ means an attestation by a national body other than the national accreditation body that the assessment body meets the requirements set out in Annex II to this Regulation to carry out the independent assessment activity specified in Article 6(1) and (2);

  • ‘reference system’ means a system proven in use to have an acceptable safety level and against which the acceptability of the risks from a system under assessment can be evaluated by comparison;

  • ‘risk’ means the frequency of occurrence of accidents and incidents resulting in harm caused by a hazard and the degree of severity of that harm;

  • ‘risk acceptance criteria’ means the terms of reference by which the acceptability of a specific risk is assessed; these criteria are used to determine that the level of a risk is sufficiently low that it is not necessary to take any immediate action to reduce it further;

  • ‘risk acceptance principle’ means the rules used in order to arrive at the conclusion whether or not the risk related to one or more specific hazards is acceptable;

  • ‘risk analysis’ means systematic use of all available information to identify hazards and to estimate the risk;

  • ‘risk assessment’ means the overall process comprising a risk analysis and a risk evaluation;

  • ‘risk estimation’ means the process used to produce a measure of the level of risks being analysed, consisting of the following steps: estimation of frequency, consequence analysis and their integration;

  • ‘risk evaluation’ means a procedure based on the risk analysis to determine whether an acceptable level of risk has been achieved;

  • ‘risk management’ means the systematic application of management policies, procedures and practices to the tasks of analysing, evaluating and controlling risks;

  • ‘safety’ means freedom from unacceptable risk of harm;

  • ‘safety acceptance’ means the status given to the change by the proposer based on the safety assessment report provided by the assessment body;

  • ‘safety assessment report’ means the document containing the conclusions of the assessment performed by an assessment body on the system under assessment;

  • ‘safety management system’ means the organisation and arrangements established by an infrastructure manager or a railway undertaking to ensure the safe management of its operations;

  • ‘safety measures’ means a set of actions either reducing the frequency of occurrence of a hazard or mitigating its consequences in order to achieve and/or maintain an acceptable level of risk;

  • ‘safety requirements’ means the safety characteristics (qualitative or quantitative, or when needed both qualitative and quantitative) necessary for the design, operation (including operational rules) and maintenance of a system in order to meet legal or company safety targets;

  • ‘system’ means any part of the railway system which is subjected to a change whereby the change may be of a technical, operational or organisational nature;

  • ‘systematic failure’ means a failure that occurs repeatedly under some particular combination of inputs or under some particular environmental or application conditions;

  • ‘systematic fault’ means an inherent fault in the specification, design, manufacturing, installation, operation or maintenance of the system under assessment;

  • ‘technical system’ means a product or an assembly of products including the design, implementation and support documentation; the development of a technical system starts with its requirements specification and ends with its acceptance; although the design of relevant interfaces with human behaviour is considered, human operators and their actions are not included in a technical system; the maintenance process is described in the maintenance manuals but is not itself part of the technical system;

  • ‘vehicle’ means a railway vehicle suitable for circulation on its own wheels on railway lines, with or without traction; a vehicle is composed of one or more structural and functional subsystems or parts of such subsystems.]

Extent Information

E8This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

[F11Article 3AU.K.Designated standards

1.Subject to paragraphs 6 and 7, in this Regulation a “designated standard” means a technical specification which is—

(a)adopted by a recognised standardisation body [F12or an international standardising body], for repeated or continuous application, with which compliance is not compulsory; and

(b)designated by the Secretary of State by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate.

2.For the purposes of paragraph 1, a “technical specification” means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following—

(a)the characteristics required of a product, including—

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

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

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

3.For the purposes of this article, a “recognised standardisation body” means any one of the following organisations—

(a)the European Committee for Standardisation (CEN);

(b)the European Committee for Electrotechnical Standardisation (Cenelec);

(c)the European Telecommunications Standards Institute (ETSI);

(d)the British Standards Institution (BSI).

[F133A.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).]

4.When considering whether the manner of publication of a reference is appropriate in accordance with paragraph 1(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.

5.Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with [F14such] technical specifications adopted by the other recognised standardisation bodies [F15or by international standardising bodies as the Secretary of State considers to be relevant].

6.The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph 1(b).

7.Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.]

Textual Amendments

Article 4U.K.Significant changes

1.[F16The proposer shall consider the potential impact of a change on the safety of the railway system.]

If the proposed change has no impact on safety, the risk management process described in Article 5 need not be applied.

2.If the proposed change has an impact on safety, the proposer shall decide, by expert judgement, on the significance of the change based on the following criteria:

(a)failure consequence: credible worst-case scenario in the event of failure of the system under assessment, taking into account the existence of safety barriers outside the system under assessment;

(b)novelty used in implementing the change: this concerns both what is innovative in the railway sector, and what is new for the organisation implementing the change;

(c)complexity of the change;

(d)monitoring: the inability to monitor the implemented change throughout the system life-cycle and intervene appropriately;

(e)reversibility: the inability to revert to the system before the change;

(f)additionality: assessment of the significance of the change taking into account all recent safety-related changes to the system under assessment and which were not judged to be significant.

3.The proposer shall keep adequate documentation to justify its decision.

Textual Amendments

Article 5U.K.Risk management process

1.The proposer shall be responsible for applying this Regulation, including the assessment of the significance of the change based on the criteria in Article 4, and for conducting the risk management process set out in Annex I.

2.The proposer shall ensure that risks introduced by its suppliers and its service providers, including their subcontractors, are also managed in compliance with this Regulation. To this end, the proposer may require through contractual arrangements that its suppliers and its service providers, including their subcontractors, participate in the risk management process set out in Annex I.

Article 6U.K.Independent assessment

1.An assessment body shall carry out an independent assessment of the suitability of both the application of the risk management process as set out in Annex I and of its results. This assessment body shall meet the criteria listed in Annex II. Where the assessment body is not already designated by existing F17... national legislation, the proposer shall appoint its own assessment body at the earliest appropriate stage of the risk assessment process.

2.To perform the independent assessment, the assessment body shall:

(a)ensure it has a thorough understanding of the significant change based on the documentation provided by the proposer;

(b)conduct an assessment of the processes used for managing safety and quality during the design and implementation of the significant change, if those processes are not already certified by a relevant conformity assessment body;

(c)conduct an assessment of the application of those safety and quality processes during the design and implementation of the significant change.

Having completed its assessment in accordance with points (a), (b) and (c), the assessment body shall deliver the safety assessment report provided for in Article 15 and Annex III.

3.Duplication of work between the following assessments shall be avoided:

(a)the assessment of conformity of the safety management system and of the system of maintenance of entities in charge of maintenance as required by [F18regulation 18A of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraph 55A of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013] [F19 regulation 16AA of the Railways (Safety Management) Regulations (Northern Ireland) 2006]; and

(b)the conformity assessment carried out by [F20an EU notified body or an approved body]; and

(c)any independent assessment carried out by the assessment body in accordance with this Regulation.

4.[F21The] proposer may choose the national safety authority as assessment body where that national safety authority offers this service and where the significant changes concern the following cases:

(a)a vehicle needs an authorisation for placing in service F22...

(b)a vehicle needs an additional authorisation for placing in service F23...

(c)the safety certificate has to be updated due to alteration of the type or extent of the operation F24...

(d)the safety certificate has to be revised due to substantial changes to the safety regulatory framework F25...

(e)the safety authorisation has to be updated due to substantial changes to the infrastructure, signalling or energy supply, or to the principles of their operation and maintenance F26...

(f)the safety authorisation has to be revised due to substantial changes to the safety regulatory framework F27...

Where a significant change concerns a structural subsystem that needs an authorisation for placing in service F28..., the proposer may choose the national safety authority as assessment body, where that national safety authority offers this service, unless the proposer has already given that task to [F29an approved body].

Textual Amendments

Article 7U.K.Accreditation/recognition of the assessment body

The assessment body provided for in Article 6 shall be either:

(a)

accredited by the national accreditation body F30... using the criteria defined in Annex II; or

(b)

recognised by the recognition body F30... using the criteria defined in Annex II; or

(c)

the national safety authority [F31where it fulfils the requirements set out in Annex II and the accreditation functions of the national safety authority are demonstrably independent of its other functions].

Textual Amendments

Article 8E+W+SAcceptance of accreditation/recognition

1.When granting the safety certificate or the safety authorisation in accordance with [F32regulation 7 or 10 of the Railways and Other Guided Transport Systems (Safety) Regulations 2006, or Chapter 3 of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013], a national safety authority shall accept accreditation or recognition [F33in Northern Ireland], as proof of the ability of the railway undertaking or infrastructure manager to act as an assessment body.

2.When granting the certificate to an entity in charge of maintenance in accordance with [F34Schedule 10 to the Railways and Other Guided Transport Systems (Safety) Regulations 2006], the certification body shall accept such accreditation or recognition [F35in Northern Ireland], as proof of the ability of the entity in charge of maintenance to act as assessment body.

Extent Information

E3This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Article 8N.I.Acceptance of accreditation/recognition

1.When granting the safety certificate or the safety authorisation in accordance with [F71regulation 5 or 8 of the Railways (Safety Management) Regulations (Northern Ireland) 2006], a national safety authority shall accept accreditation or recognition [F72in Great Britain], as proof of the ability of the railway undertaking or infrastructure manager to act as an assessment body.

F732.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E9This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Article 9U.K.Types of recognition of the assessment body

1.The following types of recognition of the assessment body may be used:

(a)recognition by the Member State [F36of the European Union] of an entity in charge of maintenance, an organisation or a part of it or an individual;

(b)recognition by the national safety authority of the ability of an organisation or a part of it or an individual to conduct independent assessment through the assessment and supervision of the safety management system of a railway undertaking or an infrastructure manager;

[F37(c)when the national safety authority is acting as certification body F38..., recognition by the national safety authority of the ability of an organisation or a part of it or an individual to conduct independent assessment through assessment and surveillance of the system of maintenance of an entity in charge of maintenance;]

(d)recognition by a recognition body designated [F39in the United Kingdom] of the ability of an entity in charge of maintenance, an organisation or a part of it or an individual to conduct independent assessment.

F402.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 10E+W+SValidity of recognition

1.In the cases referred in Article 9(1)(a) and (d) and [F41where the national safety authority is recognised as an assessment body], the period of validity of recognition shall not exceed 5 years from the date it is granted.

2.In the case referred in Article 9(1)(b):

(a)the statement of recognition for a railway undertaking or an infrastructure manager shall be displayed on the relevant safety certificate in field 5 ‘Additional Information’ of the [F42safety certificates in the form provided in Part 2 of Schedule 8 to the Railways and Other Guided Transport Systems (Safety) Regulations 2006] and in an appropriate part of the safety authorisations;

(b)the period of validity of recognition shall be limited to the validity of the safety certificate or authorisation under which it is granted. In this case, the request of recognition shall be made at the next application for renewal or update of the safety certificate or authorisation.

3.In the cases referred in Article 9(1)(c):

(a)the statement of recognition for an entity in charge of maintenance shall be displayed on the relevant certificate in field 5 ‘Additional Information’ of the [F43certificates in the forms provided in Part 1 or Part 4 of Schedule 9 to the Railways and Other Guided Transport Systems (Safety) Regulations 2006, as appropriate];

(b)the period of validity of recognition shall be limited to the validity of the certificate issued by the certification body under which it is granted. In this case, the request of recognition shall be made at the next application for renewal or update of that certificate.

Extent Information

E4This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Article 10N.I.Validity of recognition

1.In the cases referred in Article 9(1)(a) and (d) and [F74where the national safety authority is recognised as an assessment body], the period of validity of recognition shall not exceed 5 years from the date it is granted.

2.In the case referred in Article 9(1)(b):

(a)the statement of recognition for a railway undertaking or an infrastructure manager shall be displayed on the relevant safety certificate in field 5 ‘Additional Information’ of the [F75safety certificates in the form provided in Part 2 of Schedule 6 to the Railways (Safety Management) Regulations (Northern Ireland) 2006] and in an appropriate part of the safety authorisations;

(b)the period of validity of recognition shall be limited to the validity of the safety certificate or authorisation under which it is granted. In this case, the request of recognition shall be made at the next application for renewal or update of the safety certificate or authorisation.

F763.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E10This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Article 11U.K.Surveillance by recognition body

1.By analogy to the requirements in Article 5(3) and (4) of Regulation (EC) No 765/2008 for accreditation, the recognition body shall conduct periodic surveillance in order to verify that the assessment body it recognised continues to satisfy the criteria set out in Annex II during the validity of the recognition.

2.If the assessment body no longer satisfies the criteria set out in Annex II, the recognition body shall limit the scope of application of the recognition, suspend or withdraw the recognition, depending on the degree of non-compliance.

F44Article 12U.K.Relaxed criteria where a significant change is not to be mutually recognised

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F44Article 13U.K.Provision of information to the Agency

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F44Article 14U.K.Support from the Agency to accreditation or recognition of the assessment body

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 15U.K.Safety assessment reports

1.The assessment body shall provide the proposer with a safety assessment report in accordance with the requirements set out in Annex III. The proposer shall be responsible for determining if and how to take into account the conclusions of the safety assessment report for the safety acceptance of the assessed change. The proposer shall justify and document the part of the safety assessment report for which the proposer eventually disagrees.

2.In the case referred to in point (b) of Article 2(3), in accordance with paragraph 5 of this Article, the declaration referred to in Article 16 shall be accepted by the national safety authority in its decision to authorise the placing in service of structural subsystems and vehicles.

3.[F45The] national safety authority may not request additional checks or risk analyses unless it is able to demonstrate the existence of a substantial safety risk.

4.[F46Where the application of this Regulation or part of this Regulation is required by a relevant NTSN], in accordance with paragraph 5 of this Article, the declaration referred to in Article 16 shall be accepted by the [F47approved body] in charge of delivering the conformity certificate, unless it justifies and documents its doubts concerning the assumptions made or the appropriateness of the results.

5.When a system or part of a system has already been accepted following the risk management process specified in this Regulation, the resulting safety assessment report shall not be called into question by any other assessment body in charge of performing a new assessment for the same system. Mutual recognition shall be conditional upon demonstration that the system will be used under the same functional, operational and environmental conditions as the already accepted system, and that equivalent risk acceptance criteria have been applied.

Textual Amendments

Article 16U.K.Declaration by the proposer

Based on the results of the application of this Regulation and on the safety assessment report provided by the assessment body, the proposer shall produce a written declaration that all identified hazards and associated risks are controlled to an acceptable level.

Article 17E+W+SRisk control management and audits

1.The railway undertakings and infrastructure managers shall include audits of the application of this Regulation in their recurrent auditing scheme for the safety management system as referred to in [F48regulations 5 and 6 of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraphs 22 to 26 of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013].

2.The entities in charge of maintenance shall include audits of the application of this Regulation in their recurrent auditing scheme for the system of maintenance as referred to in [F49regulation 18A of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraphs 55A and 55B of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013].

3.[F50The] national safety authority shall supervise the application of this Regulation by railway undertakings, infrastructure managers and the entities in charge of maintenance that do not fall within the scope of [F51Schedule 10 to the Railways and Other Guided Transport Systems (Safety) Regulations 2006] but are identified in its National Vehicle Register.

4.As part of the tasks defined in [F52paragraph 7(1) of Schedule 10 to the Railways and Other Guided Transport Systems (Safety) Regulations 2006], the certification body of an entity in charge of maintenance of freight wagons shall perform surveillance of the application of this Regulation by the entity in charge of maintenance.

Extent Information

E5This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Article 17N.I.Risk control management and audits

1.The railway undertakings and infrastructure managers shall include audits of the application of this Regulation in their recurrent auditing scheme for the safety management system as referred to in [F77regulation 4 of the Railways (Safety Management) Regulations (Northern Ireland) 2006].

2.The entities in charge of maintenance shall include audits of the application of this Regulation in their recurrent auditing scheme for the system of maintenance as referred to in [F78regulation 16AA of the Railways (Safety Management) Regulations (Northern Ireland) 2006].

3.[F79The] national safety authority shall supervise the application of this Regulation by railway undertakings, infrastructure managers and the entities in charge of maintenance that F80... identified in its National Vehicle Register.

F814.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E11This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Article 18E+W+SFeedback and technical progress

1.Each infrastructure manager and each railway undertaking shall, in its annual safety report [F53pursuant to regulation 20(1) of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraph 16 of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013], report briefly on its experience with the application of this Regulation. The report shall also include a synthesis of the decisions on the level of significance of the changes.

F542.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.The annual maintenance report of entities in charge of maintenance of freight wagons referred to in [F55paragraph 7(4)(k) of Part 4 of Schedule 10 to the Railways and Other Guided Transport Systems (Safety) Regulations 2006], shall include information about the experience of entities in charge of maintenance in applying this Regulation. F56...

F574.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F585.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F596.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E6This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Article 18N.I.Feedback and technical progress

1.Each infrastructure manager and each railway undertaking shall, in its annual safety report [F82pursuant to regulation 18(1) of the Railways (Safety Management) Regulations (Northern Ireland) 2006], report briefly on its experience with the application of this Regulation. The report shall also include a synthesis of the decisions on the level of significance of the changes.

F832.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F833.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F834.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F835.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F836.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E12This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F60Article 19U.K.Repeal

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Article 20U.K.Entry into force and application

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

It shall apply from 21 May 2015.

F61...

Textual Amendments

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