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)

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community’s railways and amending Council Directive 95/18/EC on the licensing of railway undertakings and Directive 2001/14/EC on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (Railway Safety Directive), and in particular Article 6(4) thereof,
OJ L 164, 30.4.2004, p. 44.
Whereas:
(1) In accordance with Directive 2004/49/EC, common safety methods (CSMs) should be gradually introduced to ensure that a high level of safety is maintained and, when and where necessary and reasonably practicable, improved.
(2) On 12 October 2010 the Commission issued a mandate to the European Railway Agency (the ‘Agency’) in accordance with Directive 2004/49/EC to revise Commission Regulation (EC) No 352/2009 of 24 April 2009 on the adoption of a common safety method on risk evaluation and assessment as referred to in Article 6(3)(a) of Directive 2004/49/EC of the European Parliament and of the Council. The revision should cover the results of the analysis by the Agency under Article 9(4) of the Regulation of the overall effectiveness of the CSM for risk evaluation and assessment and experience with its application as well as further developments in the roles and the responsibilities of the assessment body referred to in Article 6 of that Regulation. The revision should also include the qualification requirements (by developing a recognition/accreditation scheme) for the assessment body according to its role in the CSM, with a view to improving clarity in order to avoid differences in application across the Member States, taking into account the interfaces with existing Union authorisation/certification procedures in the railway sector. If feasible, the revision of Regulation (EC) No 352/2009 should also cover further developments in risk acceptance criteria that could be used to assess the acceptability of a risk during explicit risk estimation and evaluation. The Agency submitted its recommendation on the revision of the CSM to the Commission, supported by an impact assessment report to address the mandate of the Commission. This Regulation is based on that Agency recommendation.
OJ L 108, 29.4.2009, p. 4.
(3) In accordance with Directive 2004/49/EC the basic elements for the safety management system should include procedures and methods for carrying out risk evaluation and implementing risk control measures whenever a change in operating conditions or new material imposes new risks on the infrastructure or on operations. That basic element of the safety management system is covered by this Regulation.
(4) Article 14a(3) of Directive 2004/49/EC requires entities in charge of maintenance to establish a system of maintenance in order to ensure that the vehicles for which they are in charge of maintenance are in a safe state of running. To manage changes in equipment, procedures, organisation, staffing or interfaces, the entities in charge of maintenance should have in place risk assessment procedures. That requirement for the system of maintenance is also covered by this Regulation.
(5) As a consequence of the application of Council Directive 91/440/EEC of 29 July 1991 on the development of the Community’s railways and of Article 9(2) of Directive 2004/49/EC, particular attention should be paid to risk management at the interfaces between the actors which are involved in the application of this Regulation.
OJ L 237, 24.8.1991, p. 25.
(6) Article 15 of Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community requires Member States to take all appropriate steps to ensure that the structural subsystems constituting the rail system may be placed in service only if they are designed, constructed and installed in such a way as to meet the essential requirements concerning them when integrated into the rail system. In particular, the Member States must check the technical compatibility of these subsystems with the railway system into which they are being integrated and the safe integration of these subsystems in accordance with the scope of this Regulation.
OJ L 191, 18.7.2008, p. 1.
(7) The absence of a common approach for specifying and demonstrating compliance with safety levels and requirements of the railway system among the Member States has proved to be one of the obstacles to liberalisation of the railway market. Such a common approach should be established through this Regulation.
(8) To facilitate mutual recognition between Member States, the methods used for identifying and managing risks and the methods for demonstrating that the railway system in the territory of the Union conforms to safety requirements should be harmonised among the actors involved in the development and operation of the railway system. As a first step, it is necessary to harmonise the procedures and methods for carrying out risk evaluation and implementing control measures whenever a change in operating conditions or new material imposes new risks on the infrastructure or on operations, as referred to in point (2)(d) of Annex III to Directive 2004/49/EC.
(9) If there is no existing notified national rule for defining whether or not a change is significant for the safety in a Member State, the company or organisation in charge of implementing the change (the ‘proposer’) should initially consider the potential impact of the change in question on the safety of the railway system. If the proposed change has an impact on safety, the proposer should assess, by expert judgement, the significance of the change based on a set of criteria that should be set out in this Regulation. This assessment should lead to one of three conclusions. In the first situation the change is not considered to be significant and the proposer should implement the change by applying its own safety method. In the second situation the change is considered to be significant and the proposer should implement the change by applying this Regulation, without the need for a specific intervention of the national safety authority. In the third situation the change is considered to be significant but there are provisions at the level of the European Union which require a specific intervention of the relevant national safety authority, such as a new authorisation for placing in service of a vehicle or a revision/update of the safety certificate of a railway undertaking or a revision/update of the safety authorisation of an infrastructure manager.
(10) Whenever the railway system already in use is subject to a change, the significance of the change should also be assessed taking into account all safety-related changes affecting the same part of the system since the entry into force of this Regulation or since the last application of the risk management process set out in this Regulation, whichever is the latest. The purpose is to assess whether or not the totality of such changes amounts to a significant change requiring the full application of the CSM for risk evaluation and assessment.
(11) The risk acceptability of a significant change should be evaluated by using one or more of the following risk acceptance principles: the application of codes of practice, a comparison with similar parts of the railway system, or an explicit risk estimation. All principles have been used successfully in a number of railway applications, as well as in other transport modes and other industries. The ‘explicit risk estimation’ principle is frequently used for complex or innovative changes. The proposer should be responsible for the choice of the principle to apply.
(12) When a widely recognised code of practice is applied, it should therefore be possible to reduce the impact of applying the CSM, in accordance with the principle of proportionality. In the same way, where there are provisions at the level of the Union which require specific intervention by the national safety authority, that authority should be allowed to act as the independent assessment body in order to reduce double checking, undue costs to the industry and time to market.
(13) To report to the Commission on the effectiveness and application of this Regulation, and where applicable to make recommendations to improve it, the Agency should be able to gather relevant information from the various actors involved, including from the national safety authorities, from the certification bodies of entities in charge of maintenance of freight wagons and from other entities in charge of maintenance that do not fall within the scope of Commission Regulation (EU) No 445/2011 of 10 May 2011 on a system of certification of entities in charge of maintenance for freight wagons.
OJ L 122, 11.5.2011, p. 22.
(14) Accreditation of an assessment body should normally be granted by the national accreditation body which has exclusive competence to assess if the assessment body meets the requirements set by harmonised standards. 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 contains detailed provisions on the competence of such national accreditation bodies.
OJ L 218, 13.8.2008, p. 30.
(15) Where harmonised Union legislation provides for the selection of conformity assessment bodies for its implementation, transparent accreditation, as provided for in Regulation (EC) No 765/2008, should be considered by the national public authorities throughout the Union as the preferred means of demonstrating the technical competence of those bodies. However, national authorities may consider that they possess the appropriate means to carry out this evaluation themselves. In such cases, the Member State should provide the Commission and the other Member States with all the documentary evidence necessary for verification of the competence of the recognition body it selects for implementation of the Union legislation. In order to achieve a similar level of quality and trust as expected through accreditation, the requirements and rules for the evaluation and surveillance of assessment bodies in the case of recognition should be equivalent to those used for accreditation.
(16) An independent and competent external or internal individual, organisation or entity, a national safety authority, a notified body or a body designated according to Article 17 of Directive 2008/57/EC could act as an assessment body provided it fulfils the criteria required in Annex II.
(17) Recognition of internal assessment bodies in compliance with this Regulation does not require an immediate revision of already delivered safety certificates to railway undertakings, safety authorisations to infrastructure managers and certificates to entities in charge of maintenance. Their revision can be made at the next application for renewal or update of the safety certificate, safety authorisation or certificate of the entity in charge of maintenance.
(18) In existing legislation there are no limits in the number of assessment bodies accredited or recognised in each Member State and there are no obligations to have at least one. Where the assessment body is not already designated by existing Union or national legislation, the proposer may appoint any assessment body in the Union or in a third country accredited under equivalent criteria and meeting equivalent requirements to those contained in this regulation. The Member State should be able to use accreditation or recognition or any combination of these two options.
(19) Regulation (EC) No 352/2009 has become obsolete and should therefore be replaced by this Regulation.
(20) In view of the new requirements introduced by the present Regulation in terms of accreditation and recognition of the assessment body, the implementation of this Regulation should be deferred in order to give sufficient time to the actors concerned to put in place and implement this new common approach.
(21) The measures provided for in this Regulation are in accordance with the opinion of the Committee established in accordance with Article 27(1) of Directive 2004/49/EC,
HAS ADOPTED THIS REGULATION:

Article 1 Subject matter
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 1 omitted (E.W.S.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(2); 2020 c. 1, Sch. 5 para. 1(1); and Art. 1 omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(2); 2020 c. 1, Sch. 5 para. 1(1)

Article 2 Scope
1. This Regulation shall apply to the proposer as defined in Article 3(11) when making any change to the railway system in Great 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.
Words in Art. 2(1) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
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 the Railways (Interoperability) Regulations 2011 apply:
(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 2(3)(a) omitted (E.W.S.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(3)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
(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 system....
Words in Art. 2(3)(b) omitted (E.W.S.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(3)(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 2(3) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(3)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
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 NTSNs. If 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.
Word in Art. 2(4) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(3)(c)(i) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(a)); 2020 c. 1, Sch. 5 para. 1(1))
Words in Art. 2(4) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(3)(c)(ii) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(a)); 2020 c. 1, Sch. 5 para. 1(1))
5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 2(5) omitted (E.W.S.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(3)(d); 2020 c. 1, Sch. 5 para. 1(1)
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 2(6) omitted (E.W.S.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(3)(d); 2020 c. 1, Sch. 5 para. 1(1)

Article 2 Scope
1. This Regulation shall apply to the proposer as defined in Article 3(11) when making any change to the railway system in Northern 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.
Words in Art. 2(1) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
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 the Railways (Interoperability) Regulations 2011 apply:
(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 2(3)(a) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(3)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
(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 system....
Words in Art. 2(3)(b) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(3)(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 2(3) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(3)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
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 NTSNs. If 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.
Word in Art. 2(4) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(3)(c)(i) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(a)); 2020 c. 1, Sch. 5 para. 1(1))
Words in Art. 2(4) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(3)(c)(ii) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(a)); 2020 c. 1, Sch. 5 para. 1(1))
5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 2(5) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(3)(d); 2020 c. 1, Sch. 5 para. 1(1)
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 2(6) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(3)(d); 2020 c. 1, Sch. 5 para. 1(1)

Article 3 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;
‘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.
Art. 3 substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(4) (as amended by S.I. 2019/1310, regs. 1(2)(c), 7(4)(b)); 2020 c. 1, Sch. 5 para. 1(1)

Article 3 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.
Art. 3 substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(4) (as amended by S.I. 2019/1310, regs. 1(2)(c), 7(7)(b)); 2020 c. 1, Sch. 5 para. 1(1)

Article 3A 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 or an international standardising body, for repeated or continuous application, with which compliance is not compulsory; and
Words in Art. 3A(1)(a) inserted (31.12.2020) by European Union (Future Relationship) Act 2020 (c. 29), s. 40(7), Sch. 4 para. 21(a); S.I. 2020/1662, reg. 2(ee)
(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).
(3A. 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).
Art. 3A(3A) inserted (31.12.2020) by European Union (Future Relationship) Act 2020 (c. 29), s. 40(7), Sch. 4 para. 21(a); S.I. 2020/1662, reg. 2(ee)
(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 such technical specifications adopted by the other recognised standardisation bodies or by international standardising bodies as the Secretary of State considers to be relevant.
Word in Art. 3A(5) inserted (31.12.2020) by European Union (Future Relationship) Act 2020 (c. 29), s. 40(7), Sch. 4 para. 21(c)(i); S.I. 2020/1662, reg. 2(ee)
Words in Art. 3A(5) inserted (31.12.2020) by European Union (Future Relationship) Act 2020 (c. 29), s. 40(7), Sch. 4 para. 21(c)(ii); S.I. 2020/1662, reg. 2(ee)
(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.
Art. 3A inserted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(5); 2020 c. 1, Sch. 5 para. 1(1); and corresponding amendment (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(5); 2020 c. 1, Sch. 5 para. 1(1)

Article 4 Significant changes
1. The 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.
Words in Art. 4(1) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(6); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 4(1) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(6); 2020 c. 1, Sch. 5 para. 1(1)
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.

Article 5 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 6 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 ... national legislation, the proposer shall appoint its own assessment body at the earliest appropriate stage of the risk assessment process.
Words in Art. 6(1) omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(a); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 6(1) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(a); 2020 c. 1, Sch. 5 para. 1(1)
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 regulation 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 regulation 16AA of the Railways (Safety Management) Regulations (Northern Ireland) 2006; and
Words in Art. 6(3)(a) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 6(3)(b) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(b); 2020 c. 1, Sch. 5 para. 1(1)
(b) the conformity assessment carried out by an EU notified body or an approved body; and
Words in Art. 6(3)(b) substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(c) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(c)(i)); 2020 c. 1, Sch. 5 para. 1(1)); and words in Art. 6(3)(a) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(c) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(c)(i)); 2020 c. 1, Sch. 5 para. 1(1)
(c) any independent assessment carried out by the assessment body in accordance with this Regulation.
4. The 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 ...
Words in Art. 6(4)(a) omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(e); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 6(4)(a) omitted (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(e); 2020 c. 1, Sch. 5 para. 1(1)
(b) a vehicle needs an additional authorisation for placing in service ...
Words in Art. 6(4)(b) omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(e); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 6(4)(b) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(e); 2020 c. 1, Sch. 5 para. 1(1)
(c) the safety certificate has to be updated due to alteration of the type or extent of the operation ...
Words in Art. 6(4)(c) omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(f); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 6(4)(c) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(f); 2020 c. 1, Sch. 5 para. 1(1)
(d) the safety certificate has to be revised due to substantial changes to the safety regulatory framework ...
Words in Art. 6(4)(d) omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(g); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 6(4)(d) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(g); 2020 c. 1, Sch. 5 para. 1(1)
(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 ...
Words in Art. 6(4)(e) omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(h); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 6(4)(e) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(h); 2020 c. 1, Sch. 5 para. 1(1)
(f) the safety authorisation has to be revised due to substantial changes to the safety regulatory framework ...
Words in Art. 6(4)(f) omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(i); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 6(4)(f) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(i); 2020 c. 1, Sch. 5 para. 1(1)
Where a significant change concerns a structural subsystem that needs an authorisation for placing in service ..., 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 an approved body.
Word in Art. 6(4) substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(d); 2020 c. 1, Sch. 5 para. 1(1); and word in Art. 6(4) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(d); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 6(4) omitted (E.W.S.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(j)(i) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(c)(ii)); 2020 c. 1, Sch. 5 para. 1(1); and words in words in Art. 6(4) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(j)(i) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(c)(ii)); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 6(4) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(7)(j)(ii) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(c)(ii)); 2020 c. 1, Sch. 5 para. 1(1); and words in words in Art. 6(4) substituted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(7)(j)(ii) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(c)(ii)); 2020 c. 1, Sch. 5 para. 1(1)

Article 7 Accreditation/recognition of the assessment body
The assessment body provided for in Article 6 shall be either:
(a) accredited by the national accreditation body ... using the criteria defined in Annex II; or
Words in Art. 7 omitted (E.W.S.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(8)(a); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 7 omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(8)(a); 2020 c. 1, Sch. 5 para. 1(1)
(b) recognised by the recognition body ... using the criteria defined in Annex II; or
(c) the national safety authority where 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.
Words in Art. 7 substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(8)(b); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 7 substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(8)(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 8 Acceptance of accreditation/recognition
1. When granting the safety certificate or the safety authorisation in accordance with regulation 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 in Northern Ireland, as proof of the ability of the railway undertaking or infrastructure manager to act as an assessment body.
Words in Art. 8(1) substituted (E.W.S.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(9)(a)(i) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(d)(i)); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 8(1) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(9)(a)(ii) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(d)(i)); 2020 c. 1, Sch. 5 para. 1(1)
2. When granting the certificate to an entity in charge of maintenance in accordance with Schedule 10 to the Railways and Other Guided Transport Systems (Safety) Regulations 2006, the certification body shall accept such accreditation or recognition in Northern Ireland, as proof of the ability of the entity in charge of maintenance to act as assessment body.
Words in Art. 8(2) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(9)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 8(2) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(9)(b)(ii) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(d)(ii)); 2020 c. 1, Sch. 5 para. 1(1)

Article 8 Acceptance of accreditation/recognition
1. When granting the safety certificate or the safety authorisation in accordance with regulation 5 or 8 of the Railways (Safety Management) Regulations (Northern Ireland) 2006, a national safety authority shall accept accreditation or recognition in Great Britain, as proof of the ability of the railway undertaking or infrastructure manager to act as an assessment body.
Words in Art. 8(1) substituted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(9)(a)(i) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(d)(i)); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 8(1) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(9)(a)(ii) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(d)(i)); 2020 c. 1, Sch. 5 para. 1(1)
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 8(2) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(9)(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 9 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 of the European Union of an entity in charge of maintenance, an organisation or a part of it or an individual;
Words in Art. 9(1)(a) inserted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(10)(a); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 9(1)(a) inserted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(10)(a); 2020 c. 1, Sch. 5 para. 1(1)
(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;
(c) when the national safety authority is acting as certification body ..., 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;
Art. 9(1)(c) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(10)(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 9(1)(c) omitted (E.W.S.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(10)(b); 2020 c. 1, Sch. 5 para. 1(1)
(d) recognition by a recognition body designated in 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.
Words in Art. 9(1)(d) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(10)(c); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 9(1)(d) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(10)(c); 2020 c. 1, Sch. 5 para. 1(1)
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 9(2) omitted (E.W.S.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(10)(d); 2020 c. 1, Sch. 5 para. 1(1); and Art. 9(2) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(10)(d); 2020 c. 1, Sch. 5 para. 1(1)

Article 10 Validity of recognition
1. In the cases referred in Article 9(1)(a) and (d) and where 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.
Words in Art. 10(1) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(11)(a); 2020 c. 1, Sch. 5 para. 1(1)
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 safety 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;
Words in Art. 10(2)(a) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(11)(b); 2020 c. 1, Sch. 5 para. 1(1)
(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 certificates 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;
Words in Art. 10(3)(a) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(11)(c); 2020 c. 1, Sch. 5 para. 1(1)
(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.

Article 10 Validity of recognition
1. In the cases referred in Article 9(1)(a) and (d) and where 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.
Words in Art. 10(1) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(11)(a); 2020 c. 1, Sch. 5 para. 1(1)
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 safety 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;
Words in Art. 10(2)(a) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(11)(b); 2020 c. 1, Sch. 5 para. 1(1)
(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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 10(3) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(11)(c); 2020 c. 1, Sch. 5 para. 1(1)

Article 11 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.

Article 12 Relaxed criteria where a significant change is not to be mutually recognised
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Arts. 12-14 omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(12); 2020 c. 1, Sch. 5 para. 1(1); and Arts. 12-14 omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(12); 2020 c. 1, Sch. 5 para. 1(1)

Article 13 Provision of information to the Agency
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 14 Support from the Agency to accreditation or recognition of the assessment body
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 15 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. The national safety authority may not request additional checks or risk analyses unless it is able to demonstrate the existence of a substantial safety risk.
Word in Art. 15(3) substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(13)(a) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(e)); 2020 c. 1, Sch. 5 para. 1(1); and word in Art. 15(3) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(13)(a) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(e)); 2020 c. 1, Sch. 5 para. 1(1)
4. Where 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 approved 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.
Words in Art. 15(4) substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(13)(b)(i) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(e)); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 15(4) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(13)(b)(i) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(e)); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 15(4) substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(13)(b)(ii) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(e)); 2020 c. 1, Sch. 5 para. 1(1); and words in Art. 15(4) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(13)(b)(ii) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(e)); 2020 c. 1, Sch. 5 para. 1(1)
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.

Article 16 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 17 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 regulations 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.
Words in Art. 17(1) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(14)(a); 2020 c. 1, Sch. 5 para. 1(1)
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 regulation 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.
Words in Art. 17(2) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(14)(b); 2020 c. 1, Sch. 5 para. 1(1)
3. The 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 Schedule 10 to the Railways and Other Guided Transport Systems (Safety) Regulations 2006 but are identified in its National Vehicle Register.
Word in Art. 17(3) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(14)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 17(3) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(14)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)
4. As part of the tasks defined in paragraph 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.
Words in Art. 17(4) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(14)(d); 2020 c. 1, Sch. 5 para. 1(1)

Article 17 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 regulation 4 of the Railways (Safety Management) Regulations (Northern Ireland) 2006.
Words in Art. 17(1) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(14)(a); 2020 c. 1, Sch. 5 para. 1(1)
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 regulation 16AA of the Railways (Safety Management) Regulations (Northern Ireland) 2006.
Words in Art. 17(2) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(14)(b); 2020 c. 1, Sch. 5 para. 1(1)
3. The national safety authority shall supervise the application of this Regulation by railway undertakings, infrastructure managers and the entities in charge of maintenance that ... identified in its National Vehicle Register.
Word in Art. 17(3) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(14)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 17(3) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(14)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 17(4) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(14)(d); 2020 c. 1, Sch. 5 para. 1(1)

Article 18 Feedback and technical progress
1. Each infrastructure manager and each railway undertaking shall, in its annual safety report pursuant 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.
Words in Art. 18(1) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(15)(a); 2020 c. 1, Sch. 5 para. 1(1)
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 18(2) omitted (E.W.S.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(15)(b); 2020 c. 1, Sch. 5 para. 1(1)
3. The annual maintenance report of entities in charge of maintenance of freight wagons referred to in paragraph 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. ...
Words in Art. 18(3) substituted (E.W.S.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(15)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 18(3) omitted (E.W.S.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(15)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 18(4) omitted (E.W.S.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(15)(d); 2020 c. 1, Sch. 5 para. 1(1)
5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 18(5) omitted (E.W.S.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(15)(d); 2020 c. 1, Sch. 5 para. 1(1)
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 18(6) omitted (E.W.S.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(15)(d); 2020 c. 1, Sch. 5 para. 1(1)

Article 18 Feedback and technical progress
1. Each infrastructure manager and each railway undertaking shall, in its annual safety report pursuant 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.
Words in Art. 18(1) substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(15)(a); 2020 c. 1, Sch. 5 para. 1(1)
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 18(2)-(6) omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(15)(b); 2020 c. 1, Sch. 5 para. 1(1)
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 19 Repeal
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Art. 19 omitted (E.W.S.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(16); 2020 c. 1, Sch. 5 para. 1(1); and Art. 19 omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(16); 2020 c. 1, Sch. 5 para. 1(1)

Article 20 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.
...
Words in Signature omitted (E.W.S.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(17); 2020 c. 1, Sch. 5 para. 1(1); and words in Signature omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(17); 2020 c. 1, Sch. 5 para. 1(1)
ANNEX I

1. GENERAL PRINCIPLES APPLICABLE TO THE RISK MANAGEMENT PROCESS

1.1. General principles and obligations

1.1.1. The risk management process shall start from a definition of the system under assessment and comprise the following activities:
(a) the risk assessment process, which shall identify the hazards, the risks, the associated safety measures and the resulting safety requirements to be fulfilled by the system under assessment;
(b) demonstration of the compliance of the system with the identified safety requirements; and
(c) management of all identified hazards and the associated safety measures.
This risk management process is iterative and is depicted in the diagram of the Appendix. The process ends when compliance of the system with all the safety requirements necessary to accept the risks linked to the identified hazards is demonstrated.
1.1.2. The risk management process shall include appropriate quality assurance activities and be carried out by competent staff. It shall be independently assessed by one or more assessment bodies.
1.1.3. The proposer in charge of the risk management process shall maintain a hazard record in accordance with point 4.

1.1.4. The actors who already have in place methods or tools for risk assessment may continue to apply them if such methods or tools are compatible with the provisions of this Regulation and subject to the following conditions:
(a) the risk assessment methods or tools are described in a safety management system accepted by a national safety authority in accordance with regulation 7(4)(b)(i) or regulation 10(1)(b)(ii) 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 2013regulation 5(4)(b)(i) or regulation 8(1)(b)(ii) of the Railways (Safety Management) Regulations (Northern Ireland) 2006; or
Words in Annex 1 point 1.1.4(a) substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Annex 1 substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(a); 2020 c. 1, Sch. 5 para. 1(1)
(b) the risk assessment methods or tools are required by an NTSN or comply with publicly available recognised standards specified in national rules.
Words in Annex 1 point 1.1.4(b) substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(aa)(i) (as inserted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(g)(i)); 2020 c. 1, Sch. 5 para. 1(1); and substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(aa)(i) (as inserted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(g)(i); 2020 c. 1, Sch. 5 para. 1(1))
Words in Annex 1 point 1.1.4(b) substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(aa)(ii) (as inserted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(g)(i); 2020 c. 1, Sch. 5 para. 1(1); and substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(aa)(ii) (as inserted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(g)(i); 2020 c. 1, Sch. 5 para. 1(1))
1.1.5. Without prejudice to civil liability in accordance with the legal requirements of the United Kingdom, the risk assessment process shall fall within the responsibility of the proposer. In particular the proposer shall decide, with agreement of the actors concerned, who will be in charge of fulfilling the safety requirements resulting from the risk assessment. The safety requirements assigned by the proposer to those actors shall not go beyond the scope of their responsibility and domain of control. This decision shall depend on the type of safety measures selected to control the risks to an acceptable level. The demonstration of compliance with the safety requirements shall be conducted in accordance with point 3.
Words in Annex 1 point 1.1.5 substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(b); 2020 c. 1, Sch. 5 para. 1(1); and substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(b); 2020 c. 1, Sch. 5 para. 1(1)
1.1.6. The first step of the risk management process shall be to identify in a document, to be drawn up by the proposer, the different actors’ tasks, and their risk management activities. The proposer is responsible for coordinating close collaboration between the different actors involved, according to their respective tasks, in order to manage the hazards and their associated safety measures.
1.1.7. Evaluation of the correct application of the risk management process falls within the responsibility of the assessment body.

1.2. Interfaces management
1.2.1. For each interface relevant to the system under assessment and without prejudice to specifications of interfaces defined in relevant NTSNs, the rail-sector actors concerned shall cooperate in order to identify and manage jointly the hazards and related safety measures that need to be handled at these interfaces. The management of shared risks at the interfaces shall be coordinated by the proposer.
Word in Annex 1 point 1.2.1 substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(bb) (as inserted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(g)(ii)); 2020 c. 1, Sch. 5 para. 1(1); and substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(bb) (as inserted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(g)(ii); 2020 c. 1, Sch. 5 para. 1(1))
1.2.2. If, in order to fulfil a safety requirement, an actor identifies the need for a safety measure that it cannot implement itself, it shall, after agreement with another actor, transfer the management of the related hazard to the latter in accordance with the process set out in point 4.
1.2.3. For the system under assessment, any actor who discovers that a safety measure is non-compliant or inadequate is responsible for notifying it to the proposer, who shall in turn inform the actor implementing the safety measure.
1.2.4. The actor implementing the safety measure shall then inform all the actors affected by the problem either within the system under assessment or, as far as known by the actor, within other existing systems using the same safety measure.
1.2.5. When agreement cannot be reached between two or more actors it is the responsibility of the proposer to find a solution.
1.2.6. When a requirement in a national rule cannot be fulfilled by an actor, the proposer shall seek advice from the relevant competent authority.
Words in Annex 1 point 1.2.6 substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(bc) (as inserted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(g)(ii)); 2020 c. 1, Sch. 5 para. 1(1); and substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(bc) (as inserted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(g)(ii); 2020 c. 1, Sch. 5 para. 1(1))
1.2.7. Independently from the definition of the system under assessment, the proposer is responsible for ensuring that the risk management covers the system itself and its integration into the railway system as a whole.

2. DESCRIPTION OF THE RISK ASSESSMENT PROCESS

2.1. General description

2.1.1. The risk assessment process is the overall iterative process that comprises:
(a) the system definition;
(b) the risk analysis including the hazard identification;
(c) the risk evaluation.
The risk assessment process shall interact with hazard management in accordance with point 4.1.

2.1.2. The system definition shall address at least the following issues:
(a) system objective (intended purpose);
(b) system functions and elements, where relevant (including human, technical and operational elements);
(c) system boundary including other interacting systems;
(d) physical (interacting systems) and functional (functional input and output) interfaces;
(e) system environment (for example energy and thermal flow, shocks, vibrations, electromagnetic interference, operational use);
(f) existing safety measures and, after the necessary relevant iterations, definition of the safety requirements identified by the risk assessment process;
(g) assumptions that determine the limits for the risk assessment.
2.1.3. A hazard identification shall be carried out on the defined system, in accordance with point 2.2.

2.1.4. The risk acceptability of the system under assessment shall be evaluated by using one or more of the following risk acceptance principles:
(a) the application of codes of practice (point 2.3);
(b) a comparison with similar systems (point 2.4);
(c) an explicit risk estimation (point 2.5).
In accordance with the principle referred to in point 1.1.5, the assessment body shall refrain from imposing the risk acceptance principle to be used by the proposer.
2.1.5. The proposer shall demonstrate in the risk evaluation that the selected risk acceptance principle is adequately applied. The proposer shall also check that the selected risk acceptance principles are used consistently.
2.1.6. The application of these risk acceptance principles shall identify possible safety measures that make the risk(s) of the system under assessment acceptable. Among these safety measures, those selected to control the risk(s) shall become the safety requirements to be fulfilled by the system. Compliance with these safety requirements shall be demonstrated in accordance with point 3.
2.1.7. The iterative risk assessment process is considered to be completed when it is demonstrated that all safety requirements are fulfilled and no additional reasonably foreseeable hazards have to be considered.

2.2. Hazard identification

2.2.1. The proposer shall systematically identify, using wide-ranging expertise from a competent team, all reasonably foreseeable hazards for the whole system under assessment, its functions where appropriate and its interfaces.
All identified hazards shall be registered in the hazard record in accordance with point 4.
2.2.2. To focus the risk assessment efforts upon the most important risks, the hazards shall be classified according to the estimated risk arising from them. Based on expert judgement, hazards associated with a broadly acceptable risk need not be analysed further but shall be registered in the hazard record. Their classification shall be justified in order to allow independent assessment by an assessment body.
2.2.3. As a criterion, risks resulting from hazards may be classified as broadly acceptable when the risk is so small that it is not reasonable to implement any additional safety measure. The expert judgement shall take into account that the contribution of all the broadly acceptable risks does not exceed a defined proportion of the overall risk.
2.2.4. During the hazard identification, safety measures may be identified. They shall be registered in the hazard record in accordance with point 4.
2.2.5. The hazard identification only needs to be carried out at a level of detail necessary to identify where safety measures are expected to control the risks in accordance with one of the risk acceptance principles referred to in point 2.1.4. Iteration may be necessary between the risk analysis and the risk evaluation phases until a sufficient level of detail is reached for the identification of hazards.

2.2.6. Whenever a code of practice or a reference system is used to control the risk, hazard identification may be limited to:
(a) verification of the relevance of the code of practice or reference system;
(b) identification of the deviations from the code of practice or from the reference system.

2.3. Use of codes of practice and risk evaluation
2.3.1. The proposer, with the support of other involved actors, shall analyse whether one, several or all hazards are appropriately covered by the application of relevant codes of practice.

2.3.2. The codes of practice shall satisfy at least the following requirements:
(a) They must be widely recognised in the railway domain. If this is not the case, the codes of practice will have to be justified and be acceptable to the assessment body;
(b) They must be relevant for the control of the considered hazards in the system under assessment. Successful application of a code of practice for similar cases to manage changes and control effectively the identified hazards of a system in the sense of this Regulation is sufficient for it to be considered as relevant;
(c) Upon request, they must be available to assessment bodies for them to either assess or, where relevant, mutually recognise, in accordance with Article 15(5), the suitability of both the application of the risk management process and of its results.
2.3.3. Where compliance with NTSNs is required ... and the relevant NTSN does not impose the risk management process established by this Regulation, the NTSNs may be considered as codes of practice for controlling hazards, provided requirement (b) of point 2.3.2 is fulfilled.
Word in Annex 1 point 2.3.3 substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(c)(i) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(g)(iii)); 2020 c. 1, Sch. 5 para. 1(1)); and substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(c)(i) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(g)(iii); 2020 c. 1, Sch. 5 para. 1(1))
Word in Annex 1 point 2.3.3 omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(c)(ii) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(g)(iii)); 2020 c. 1, Sch. 5 para. 1(1); and omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(c)(ii) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(g)(iii); 2020 c. 1, Sch. 5 para. 1(1))
Word in Annex 1 point 2.3.3 substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(c)(iii) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(g)(iii)); 2020 c. 1, Sch. 5 para. 1(1); and substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(c)(iii) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(g)(iii); 2020 c. 1, Sch. 5 para. 1(1))
2.3.4. National rules ... may be considered as codes of practice provided the requirements of point 2.3.2 are fulfilled.
Words in Annex 1 point 2.3.4 omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(cc) (as inserted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(g)(iv)); 2020 c. 1, Sch. 5 para. 1(1); and omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(cc) (as inserted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(g)(iv); 2020 c. 1, Sch. 5 para. 1(1))

2.3.5. If one or more hazards are controlled by codes of practice fulfilling the requirements of point 2.3.2, then the risks associated with these hazards shall be considered acceptable. This means that:
(a) these risks need not be analysed further;
(b) the use of the codes of practice shall be registered in the hazard record as safety requirements for the relevant hazards.
2.3.6. Where an alternative approach is not fully compliant with a code of practice, the proposer shall demonstrate that the alternative approach pursued leads to at least the same level of safety.
2.3.7. If the risk for a particular hazard cannot be made acceptable by the application of codes of practice, additional safety measures shall be identified by applying one of the two other risk acceptance principles.

2.3.8. When all hazards are controlled by codes of practice, the risk management process may be limited to:
(a) hazard identification in accordance with point 2.2.6;
(b) registration of the use of the codes of practice in the hazard record in accordance with point 2.3.5;
(c) documentation of the application of the risk management process in accordance with point 5;
(d) an independent assessment in accordance with Article 6.

2.4. Use of reference system and risk evaluation
2.4.1. The proposer, with the support of other involved actors, shall analyse whether one, several or all hazards are appropriately covered by a similar system that could be taken as a reference system.

2.4.2. A reference system shall satisfy at least the following requirements:
(a) it has already been proven in-use to have an acceptable safety level in the United Kingdom;
Words in Annex 1 point 2.4.2(a) substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(d); 2020 c. 1, Sch. 5 para. 1(1); and substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(d); 2020 c. 1, Sch. 5 para. 1(1)
(b) it has similar functions and interfaces as the system under assessment;
(c) it is used under similar operational conditions as the system under assessment;
(d) it is used under similar environmental conditions as the system under assessment.

2.4.3. If a reference system fulfils the requirements listed in point 2.4.2, then for the system under assessment:
(a) the risks associated with the hazards covered by the reference system shall be considered as acceptable;
(b) the safety requirements for the hazards covered by the reference system may be derived from the safety analyses or from an evaluation of safety records of the reference system;
(c) these safety requirements shall be registered in the hazard record as safety requirements for the relevant hazards.
2.4.4. If the system under assessment deviates from the reference system, the risk evaluation shall demonstrate that the system under assessment reaches at least the same safety level as the reference system, applying another reference system or one of the two other risk acceptance principles. The risks associated with the hazards covered by the reference system shall, in that case, be considered as acceptable.
2.4.5. If at least the same safety level as the reference system cannot be demonstrated, additional safety measures shall be identified for the deviations, applying one of the two other risk acceptance principles.

2.5. Explicit risk estimation and evaluation
2.5.1. If the hazards are not covered by one of the two risk acceptance principles laid down in points 2.3 and 2.4, the demonstration of risk acceptability shall be performed by explicit risk estimation and evaluation. Risks resulting from these hazards shall be estimated either quantitatively or qualitatively, or when necessary both quantitatively and qualitatively, taking existing safety measures into account.
Substituted by Commission Implementing Regulation (EU) 2015/1136 of 13 July 2015 amending Implementing Regulation (EU) No 402/2013 on the common safety method for risk evaluation and assessment (Text with EEA relevance).

2.5.2. The acceptability of the estimated risks shall be evaluated using risk acceptance criteria either derived from or based on requirements contained in legislation applying in Great Britainlegislation applying in Northern Ireland or in national rules. Depending on the risk acceptance criteria, the acceptability of the risk may be evaluated either individually for each associated hazard or the combination of all hazards as a whole considered in the explicit risk estimation.
If the estimated risk is not acceptable, additional safety measures shall be identified and implemented in order to reduce the risk to an acceptable level.
Words in Annex 1 point 2.5.2 substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(e)(i) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(g)(v)); 2020 c. 1, Sch. 5 para. 1(1)
Words in Annex 1 substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(e)(i) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(g)(v)); 2020 c. 1, Sch. 5 para. 1(1)
Words in Annex 1 point 2.5.2 substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(e)(ii) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(g)(v)); 2020 c. 1, Sch. 5 para. 1(1); and substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(e)(ii) (as substituted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(g)(v); 2020 c. 1, Sch. 5 para. 1(1))
2.5.3. If the risk associated with one hazard or a combination of several hazards is considered acceptable, the identified safety measures shall be registered in the hazard record.
2.5.4. The proposer shall not be obliged to perform additional explicit risk estimation for risks that are already considered acceptable by the use of codes of practice or reference systems.

2.5.5. Where hazards arise as a result of failures of functions of a technical system, without prejudice to points 2.5.1 and 2.5.4, the following ... design targets shall apply to those failures:
(a) where a failure has a credible potential to lead directly to a catastrophic accident, the associated risk does not have to be reduced further if the frequency of the failure of the function has been demonstrated to be highly improbable.
(b) where a failure has a credible potential to lead directly to a critical accident, the associated risk does not have to be reduced further if the frequency of the failure of the function has been demonstrated to be improbable.
The choice between catastrophic accident or critical accident shall result from the most credible unsafe consequence of the failure.
Word in Annex 1 points 2.5.5-2.5.8 omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(f); 2020 c. 1, Sch. 5 para. 1(1); and omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(f); 2020 c. 1, Sch. 5 para. 1(1)
Words in Annex 1 point 2.5.5 substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(ff) (as inserted by S.I. 2019/1310, regs. 1(2)(c), 7(4)(g)(vi)); 2020 c. 1, Sch. 5 para. 1(1); and substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(ff) (as inserted by S.I. 2019/1310, regs. 1(2)(c), 7(7)(g)(vi); 2020 c. 1, Sch. 5 para. 1(1))

2.5.6. Without prejudice to points 2.5.1 and 2.5.4, the ... design targets set out in point 2.5.5 shall be used for the design of electrical, electronic and programmable electronic technical systems. ...
They shall neither be used as overall quantitative targets for the whole railway system ... nor for the design of purely mechanical technical systems.
For mixed technical systems composed of both a purely mechanical part and an electrical, electronic and programmable electronic part, hazard identification shall be carried out in accordance with point 2.2.5. The hazards arising from the purely mechanical part shall not be controlled using the ... design targets set out in point 2.5.5.
Words in Annex 1 point 2.5.6 omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(g)(i); 2020 c. 1, Sch. 5 para. 1(1); and omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(g)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Annex 1 point 2.5.6 omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(g)(ii); 2020 c. 1, Sch. 5 para. 1(1); and omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(g)(ii); 2020 c. 1, Sch. 5 para. 1(1)

2.5.7. The risk associated with the failures of functions of technical systems referred to in point 2.5.5 shall be considered as acceptable if the following requirements are also fulfilled:
(a) Compliance with the applicable ... design targets has been demonstrated;
(b) The associated systematic failures and systematic faults are controlled in accordance with safety and quality processes commensurate with the ... design target applicable to the technical system under assessment and defined in commonly acknowledged relevant standards;
(c) The application conditions for the safe integration of the technical system under assessment into the railway system shall be identified and registered in the hazard record in accordance with point 4. In accordance with point 1.2.2, these application conditions shall be transferred to the actor responsible for the demonstration of the safe integration.

2.5.8. The following specific definitions shall apply in reference to the ... quantitative design targets of technical systems:
(a) The term ‘directly’ means that the failure of the function has the potential to lead to the type of accident referred to in point 2.5.5 without the need for additional failures to occur;
(b) The term ‘potential’ means that the failure of the function may lead to the type of accident referred to in point 2.5.5;
Inserted by Commission Implementing Regulation (EU) 2015/1136 of 13 July 2015 amending Implementing Regulation (EU) No 402/2013 on the common safety method for risk evaluation and assessment (Text with EEA relevance).
2.5.9. Where the failure of a function of the technical system under assessment does not lead directly to the risk under consideration, the application of less demanding design targets shall be permitted if the proposer can demonstrate that the use of barriers as defined in Article 3(34) allows the same level of safety to be achieved.
2.5.10. . . . . . . . . . . . . . . . . . . . . . .
Annex 1 point 2.5.10 omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(h); 2020 c. 1, Sch. 5 para. 1(1); and omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(h); 2020 c. 1, Sch. 5 para. 1(1)

2.5.11. Where a technical system is developed on the basis of the requirements set out in point 2.5.5, the principle of mutual recognition is applicable in accordance with Article 15(5).
Nevertheless, if for a specific hazard the proposer can demonstrate that the existing level of safety in the United Kingdom can be maintained with a design target that is less demanding than the design target, then this less demanding design target may be used instead ....
Words in Annex 1 point 2.5.11 substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(i)(i); 2020 c. 1, Sch. 5 para. 1(1); and substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(i)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Annex 1 point 2.5.11 substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(i)(ii); 2020 c. 1, Sch. 5 para. 1(1); and substituted (N.I.) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(i)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Annex 1 point 2.5.11 omitted (E.W.S) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(18)(i)(iii); 2020 c. 1, Sch. 5 para. 1(1); and omitted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(18)(i)(iii); 2020 c. 1, Sch. 5 para. 1(1)

2.5.12. The explicit risk estimation and evaluation shall satisfy at least the following requirements:
(a) the methods used for explicit risk estimation shall reflect correctly the system under assessment and its parameters (including all operational modes);
(b) the results shall be sufficiently accurate to provide a robust basis for decision-making. Minor changes in input assumptions or prerequisites shall not result in significantly different requirements.

3. DEMONSTRATION OF COMPLIANCE WITH SAFETY REQUIREMENTS
3.1. Prior to the safety acceptance of the change, fulfilment of the safety requirements resulting from the risk assessment phase shall be demonstrated under the supervision of the proposer.
3.2. This demonstration shall be carried out by each of the actors responsible for fulfilling the safety requirements, as decided in accordance with point 1.1.5.
3.3. The approach chosen for demonstrating compliance with the safety requirements as well as the demonstration itself shall be independently assessed by an assessment body.
3.4. Any inadequacy of safety measures expected to fulfil the safety requirements or any hazards discovered during the demonstration of compliance with the safety requirements shall lead to reassessment and evaluation of the associated risks by the proposer in accordance with point 2. The new hazards shall be registered in the hazard record in accordance with point 4.

4. HAZARD MANAGEMENT

4.1. Hazard management process
4.1.1. Hazard record(s) shall be created or updated (where they already exist) by the proposer during design and implementation until acceptance of the change or delivery of the safety assessment report. A hazard record shall track the progress in monitoring risks associated with the identified hazards. Once the system has been accepted and is in operation, the hazard record shall be further maintained by the infrastructure manager or the railway undertaking in charge of the operation of the system under assessment as an integrated part of its safety management system.
4.1.2. The hazard record shall include all hazards, together with all related safety measures and system assumptions identified during the risk assessment process. It shall contains a clear reference to the origin of the hazards and to the selected risk acceptance principles and clearly identify the actor(s) in charge of controlling each hazard.

4.2. Exchange of information
All hazards and related safety requirements that cannot be controlled by one actor alone shall be communicated to another relevant actor in order to find jointly an adequate solution. The hazards registered in the hazard record of the actor who transfers them shall only be regarded as controlled when the evaluation of the risks associated with these hazards is made by the other actor and the solution is agreed by all concerned.

5. EVIDENCE FROM THE APPLICATION OF THE RISK MANAGEMENT PROCESS
5.1. The risk management process used to assess the safety levels and compliance with safety requirements shall be documented by the proposer in such a way that all the necessary evidence showing the suitability of both the application of the risk management process and of its results are accessible to an assessment body.
5.2. The documentation produced by the proposer under point 5.1 shall at least include:
(a) a description of the organisation and the experts appointed to carry out the risk assessment process;
(b) results of the different phases of the risk assessment and a list of all the necessary safety requirements to be fulfilled in order to control the risk to an acceptable level;
(c) evidence of compliance with all the necessary safety requirements;
(d) all assumptions relevant for system integration, operation or maintenance, which were made during system definition, design and risk assessment.
5.3. The assessment body shall establish its conclusion in a safety assessment report as defined in Annex III.
Appendix

Risk management process and independent assessment

ANNEX II CRITERIA FOR ACCREDITATION OR RECOGNITION OF THE ASSESSMENT BODY

1. The assessment body shall fulfil all requirements of the ISO/IEC 17020:2012 standard and of its subsequent amendments. The assessment body shall exercise professional judgement in performing the inspection work defined in that standard. The assessment body shall fulfil both the general criteria concerning competence and independence in that standard and the following specific competence criteria:
(a) competence in risk management: knowledge and experience of the standard safety analysis techniques and of the relevant standards;
(b) all relevant competences for assessing the parts of the railway system affected by the change;
(c) competence in the correct application of safety and quality management systems or in auditing management systems.
2. The assessment body shall be accredited or recognised for the different areas of competence within the railway system, or parts of it for which an essential safety requirement exists, including the area of competence involving the operation and maintenance of the railway system.
Word in Annex 2 para. 2 substituted (E.W.S) (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 16(19); 2020 c. 1, Sch. 5 para. 1(1); and word in Annex 2 para. 2 substituted (N.I.) (31.12.2020) by virtue of The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), regs. 1, 21(19); 2020 c. 1, Sch. 5 para. 1(1)

3. The assessment body shall be accredited or recognised for assessing the overall consistency of the risk management and the safe integration of the system under assessment into the railway system as a whole. This shall include competence of the assessment body in checking the following:
(a) organisation, that is the arrangements necessary to ensure a coordinated approach to achieving system safety through a uniform understanding and application of risk control measures for subsystems;
(b) methodology, that is evaluation of the methods and resources deployed by various stakeholders to support safety at subsystem and system level; and
(c) the technical aspects necessary for assessing the relevance and completeness of risk assessments and the level of safety for the system as a whole.
4. The assessment body may be accredited or recognised for one, several or all of the areas of competence listed in points 2 and 3.

ANNEX III SAFETY ASSESSMENT REPORT OF THE ASSESSMENT BODY
The safety assessment report of the assessment body shall contain at least the following information:
(a) identification of the assessment body;
(b) the independent assessment plan;
(c) the definition of the scope of the independent assessment as well as its limitations;
(d) the results of the independent assessment including in particular:
(i) detailed information on the independent assessment activities for checking the compliance with the provisions of this Regulation;
(ii) any identified cases of non-compliances with the provisions of this Regulation and the assessment body’s recommendations;
(e) the conclusions of the independent assessment.

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