http://www.legislation.gov.uk/eur/2013/402/article/3Commission 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)Commission Implementing Regulation (EU) No 402/2013Commission 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)King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02013R0402-20150803texttext/xmlen2024-10-09Expert Participation2020-12-31 DefinitionsArticle 3For 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 safety authority; andthe 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 railway undertaking or an infrastructure manager;an entity in charge of maintenance; a contracting entity or manufacturer which invites— 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; oran 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.DefinitionsArticle 3For 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 railway undertaking or an infrastructure manager;an entity in charge of maintenance; a contracting entity or manufacturer which invites— 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; oran 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.This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland onlyThis version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland onlyArt. 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)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)