Prováděcí nařízení Komise (EU) č. 402/2013 ze dne 30. dubna 2013 o společné bezpečnostní metodě pro hodnocení a posuzování rizik a o zrušení nařízení (ES) č. 352/2009 (Text s významem pro EHP)

Identifier:: 32013R0402
Status:: effective
Text language:: en

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)OJ L 164, 30.4.2004, p. 44 . , and in particular Article 6(4) thereof,

This Regulation establishes a revised common safety method (CSM) for risk evaluation and assessment as referred to in Article 6(3)(a) of Directive 2004/49/EC.

This Regulation shall facilitate the access to the market for rail transport services through harmonisation of:

(a) the risk management processes used to assess the impact of changes on safety levels and compliance with safety requirements;

(b) the exchange of safety-relevant information between different actors within the rail sector in order to manage safety across the different interfaces which may exist within this sector;

OJ L 164, 30.4.2004, p. 44 .

(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 CouncilOJ L 108, 29.4.2009, p. 4 . . 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.

(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 railwaysOJ L 237, 24.8.1991, p. 25 . 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.

(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 CommunityOJ L 191, 18.7.2008, p. 1 . 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.

(7) The absence of a common approach for specifying and demonstrating compliance with safety levels and requirements of the railway system among the Member

(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 wagonsOJ 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 productsOJ L 218, 13.8.2008, p. 30 . contains detailed provisions on the competence of such national accreditation bodies.

(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

(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,

This Regulation shall apply to the proposer as defined in Article 3(11) when making any change to the railway system in a Member State.

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.

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.

This Regulation shall apply also to structural sub-systems to which Directive 2008/57/EC applies:

(a) if a risk assessment is required by the relevant technical specification for interoperability (TSI); in this case the TSI shall, where appropriate, specify which parts of this Regulation apply;

(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, by virtue of Article 15(1) of Directive 2008/57/EC.

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 TSIs. If such contradictions occur, the proposer shall inform the Member State concerned which may then decide to ask for a revision of the TSI in accordance with Article 6(2) or Article 7 of Directive 2008/57/EC or a derogation in accordance with Article 9(2) of that Directive.

The railway systems excluded from the scope of Directive 2004/49/EC according to its Article 2(2) are excluded from the scope of this Regulation.

The provisions of Regulation (EC) No 352/2009 shall continue to apply in relation to projects which are at an advanced stage of development within the meaning of Article 2(t) of Directive 2008/57/EC at the date of application of this Regulation.

OJ L 108, 29.4.2009, p. 4 .

Article 1 Article 1 Subject matter 1.This Regulation establishes a revised common safety method (CSM) for risk evaluation and assessment as referred to in Article 6(3)(a) of Directive 2004/49/EC. 2.This Regulation shall facilitate the access to the market for rail transport services through harmonisation of: (a) the risk management processes used to assess the impact of changes on safety levels and compliance with safety requirements;(b) the exchange of safety-relevant information between different actors within the rail sector in order to manage safety across the different interfaces which may exist within this sector;(c) the evidence resulting from the application of a risk management process.

Article 2 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 a Member State. Such changes may be of a technical, operational or organisational nature. As regards organisational changes, only those changes which could impact the operational or maintenance processes shall be subjected to consideration under the rules of Article 4. 2.When, on the basis of an assessment under the criteria set out in Article 4(2)(a) to (f): (a) the change is considered significant, the risk management process set out in Article 5 shall be applied;(b) the change is considered not significant, keeping adequate documentation to justify the decision shall be sufficient. 3.This Regulation shall apply also to structural sub-systems to which Directive 2008/57/EC applies: (a) if a risk assessment is required by the relevant technical specification for interoperability (TSI); in this case the TSI shall, where appropriate, specify which parts of this Regulation apply;(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, by virtue of Article 15(1) of Directive 2008/57/EC. 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 TSIs. If such contradictions occur, the proposer shall inform the Member State concerned which may then decide to ask for a revision of the TSI in accordance with Article 6(2) or Article 7 of Directive 2008/57/EC or a derogation in accordance with Article 9(2) of that Directive. 5.The railway systems excluded from the scope of Directive 2004/49/EC according to its Article 2(2) are excluded from the scope of this Regulation. 6.The provisions of Regulation (EC) No 352/2009 shall continue to apply in relation to projects which are at an advanced stage of development within the meaning of Article 2(t) of Directive 2008/57/EC at the date of application of this Regulation.

Article 3 Article 3 Definitions

Article 4 Article 4 Significant changes 1.If there is no notified national rule for defining whether a change is significant or not in a Member State, the proposer shall consider the potential impact of the change in question on the safety of the railway system. If the proposed change has no impact on safety, the risk management process described in Article 5 need not be applied. 2.If the proposed change has an impact on safety, the proposer shall decide, by expert judgement, on the significance of the change based on the following criteria: (a) failure consequence: credible worst-case scenario in the event of failure of the system under assessment, taking into account the existence of safety barriers outside the system under assessment;(b) novelty used in implementing the change: this concerns both what is innovative in the railway sector, and what is new for the organisation implementing the change;(c) complexity of the change;(d) monitoring: the inability to monitor the implemented change throughout the system life-cycle and intervene appropriately;(e) reversibility: the inability to revert to the system before the change;(f) additionality: assessment of the significance of the change taking into account all recent safety-related changes to the system under assessment and which were not judged to be significant. 3.The proposer shall keep adequate documentation to justify its decision.

Article 5 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 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 Union or national legislation, the proposer shall appoint its own assessment body at the earliest appropriate stage of the risk assessment process. 2.To perform the independent assessment, the assessment body shall: (a) ensure it has a thorough understanding of the significant change based on the documentation provided by the proposer;(b) conduct an assessment of the processes used for managing safety and quality during the design and implementation of the significant change, if those processes are not already certified by a relevant conformity assessment body;(c) conduct an assessment of the application of those safety and quality processes during the design and implementation of the significant change. Having completed its assessment in accordance with points (a), (b) and (c), the assessment body shall deliver the safety assessment report provided for in Article 15 and Annex III. 3.Duplication of work between the following assessments shall be avoided: (a) the assessment of conformity of the safety management system and of the system of maintenance of entities in charge of maintenance as required by Directive 2004/49/EC; and(b) the conformity assessment carried out by a notified body as defined by Article 2(j) of Directive 2008/57/EC or a body designated in accordance with Article 17 of that Directive; and(c) any independent assessment carried out by the assessment body in accordance with this Regulation. 4.Without prejudice to Union legislation, 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, as referred to in Articles 22(2) and 24(2) of Directive 2008/57/EC;(b) a vehicle needs an additional authorisation for placing in service, as referred to in Articles 23(5) and 25(4) of Directive 2008/57/EC;(c) the safety certificate has to be updated due to alteration of the type or extent of the operation, as referred to in Article 10(5) of Directive 2004/49/EC;(d) the safety certificate has to be revised due to substantial changes to the safety regulatory framework, as referred to in Article 10(5) of Directive 2004/49/EC;(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, as referred to in Article 11(2) of Directive 2004/49/EC;(f) the safety authorisation has to be revised due to substantial changes to the safety regulatory framework, as referred to in Article 11(2) of Directive 2004/49/EC. Where a significant change concerns a structural subsystem that needs an authorisation for placing in service as referred to in Article 15(1) or Article 20 of Directive 2008/57/EC, 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 a notified body in accordance with Article 18(2) of that Directive.

Article 7 Article 7 Accreditation/recognition of the assessment body

Article 8 Article 8 Acceptance of accreditation/recognition 1.When granting the safety certificate or the safety authorisation in accordance with Commission Regulation (EU) No 1158/2010OJ L 326, 10.12.2010, p. 11 . or Commission Regulation (EU) No 1169/2010OJ L 327, 11.12.2010, p. 13 . , a national safety authority shall accept accreditation or recognition by a Member State in accordance with Article 7, as proof of the ability of the railway undertaking or infrastructure manager to act as an assessment body. 2.When granting the certificate to an entity in charge of maintenance in accordance with Regulation (EU) No 445/2011, the certification body shall accept such accreditation or recognition by a Member State, as proof of the ability of the entity in charge of maintenance to act as assessment body.

Article 9 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 an entity in charge of maintenance, an organisation or a part of it or an individual;(b) recognition by the national safety authority of the ability of an organisation or a part of it or an individual to conduct independent assessment through the assessment and supervision of the safety management system of a railway undertaking or an infrastructure manager;(c) when the national safety authority is acting as certification body in conformity with Article 10 of Regulation (EU) No 445/2011, recognition by the national safety authority of the ability of an organisation or a part of it or an individual to conduct independent assessment through assessment and surveillance of the system of maintenance of an entity in charge of maintenance;(d) recognition by a recognition body designated by the Member State of the ability of an entity in charge of maintenance, an organisation or a part of it or an individual to conduct independent assessment. 2.When the Member State recognises the national safety authority as an assessment body, it is the responsibility of that Member State to ensure that the national safety authority fulfills the requirements set out in Annex II; In this case, the assessment body functions of the national safety authority shall be demonstrably independent of the other functions of the national safety authority.

Article 10 Article 10 Validity of recognition 1.In the cases referred in Article 9(1)(a) and (d) and Article 9(2), the period of validity of recognition shall not exceed 5 years from the date it is granted. 2.In the case referred in Article 9(1)(b): (a) the statement of recognition for a railway undertaking or an infrastructure manager shall be displayed on the relevant safety certificate in field 5 Additional Information of theOJ L 153, 14.6.2007, p. 9 . and in an appropriate part of the safety authorisations;(b) the period of validity of recognition shall be limited to the validity of the safety certificate or authorisation under which it is granted. In this case, the request of recognition shall be made at the next application for renewal or update of the safety certificate or authorisation. 3.In the cases referred in Article 9(1)(c): (a) the statement of recognition for an entity in charge of maintenance shall be displayed on the relevant certificate in field 5 Additional Information of the harmonised format of certificates for entities in charge of maintenance provided in Annex V, or in Annex VI where relevant, of Regulation (EU) No 445/2011;(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 11 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 Article 12 Relaxed criteria where a significant change is not to be mutually recognised

Article 13 Article 13 Provision of information to the Agency 1.Where applicable, by no later than 21 May 2015 , Member States shall inform the Agency which is their national accreditation body and/or recognition body or recognition bodies for the purposes of this Regulation, as well as of the assessment bodies they recognised in conformity with Article 9(1)(a). They shall also notify any change to that situation within one month of the change. The Agency shall make this information publicly available. 2.By no later than 21 May 2015 , the national accreditation body shall inform the Agency of the assessment bodies accredited, as well as of the area of competence for which those assessment bodies are accredited as provided for in points 2 and 3 of Annex II. They shall also notify any change to that situation within 1 month of the change. The Agency shall make this information publicly available. 3.By no later than 21 May 2015 , the recognition body shall inform the Agency of the assessment bodies recognised, as well as of the area of competence for which those assessment bodies are recognised as provided for in points 2 and 3 of Annex II. They shall also notify any change to that situation within 1 month of the change. The Agency shall make this information publicly available.

Article 14 Article 14 Support from the Agency to accreditation or recognition of the assessment body 1.The Agency shall organise peer evaluations between the recognition bodies based on the same principles as set out in Article 10 of Regulation (EC) No 765/2008. 2.The Agency shall organise, in collaboration with the European cooperation for Accreditation (EA), training on this Regulation for the national accreditation bodies and for the recognition bodies at least at each new revision of this Regulation.

Article 15 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.Without prejudice to Article 16 of Directive 2008/57/EC, 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. 4.In the case referred to in point (a) of Article 2(3), in accordance with paragraph 5 of this Article, the declaration referred to in Article 16 shall be accepted by the notified body in charge of delivering the conformity certificate, unless it justifies and documents its doubts concerning the assumptions made or the appropriateness of the results. 5.When a system or part of a system has already been accepted following the risk management process specified in this Regulation, the resulting safety assessment report shall not be called into question by any other assessment body in charge of performing a new assessment for the same system. Mutual recognition shall be conditional upon demonstration that the system will be used under the same functional, operational and environmental conditions as the already accepted system, and that equivalent risk acceptance criteria have been applied.

Article 16 Article 16 Declaration by the proposer

Article 17 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 Article 9 of Directive 2004/49/EC. 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 Article 14a(3) of Directive 2004/49/EC. 3.As part of the tasks defined in Article 16(2)(e) of Directive 2004/49/EC, 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 Regulation (EU) No 445/2011 but are identified in its National Vehicle Register. 4.As part of the tasks defined in Article 7(1) of Regulation (EU) No 445/2011, 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.

Article 18 Article 18 Feedback and technical progress 1.Each infrastructure manager and each railway undertaking shall, in its annual safety report referred to in Article 9(4) of Directive 2004/49/EC, 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. 2.Each national safety authority shall, in its annual safety report referred to in Article 18 of Directive 2004/49/EC, report on the experience of the proposers with the application of this Regulation, and, where appropriate, its own experience. 3.The annual maintenance report of entities in charge of maintenance of freight wagons referred to in point I(7)(4)(k) in Annex III to Regulation (EU) No 445/2011, shall include information about the experience of entities in charge of maintenance in applying this Regulation. The Agency shall gather this information in coordination with the respective certification bodies. 4.The other entities in charge of maintenance that do not fall within the scope of Regulation (EU) No 445/2011 shall also share their experience with the Agency on the application of this Regulation. The Agency shall coordinate the sharing of experience with these entities in charge of maintenance and with the national safety authorities. 5.The Agency shall collect all information on the experience of the application of this Regulation and shall, when necessary, make recommendations to the Commission with a view to improving this Regulation. 6.Before 21 May 2018 the Agency shall submit to the Commission a report containing: (a) an analysis of the experience with the application of this Regulation, including cases where the CSM has been applied by proposers on a voluntary basis before the relevant date of application provided for in Article 20;(b) an analysis of the experience of proposers concerning decisions on the level of significance of changes;(c) an analysis of the cases where codes of practice have been used as set out in point 2.3.8 of Annex I;(d) an analysis of the experience with the accreditation and recognition of assessment bodies;(e) an analysis of the overall effectiveness of this Regulation. The national safety authorities shall support the Agency in collecting such information.

Article 19 Article 19 Repeal

Article 20 Article 20 Entry into force and application

For the purpose of this Regulation the definitions in Article 3 of Directive 2004/49/EC apply.

The following definitions also apply:

OJ L 237, 24.8.1991, p. 25 .

(1) 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;

(2) risk analysis means systematic use of all available information to identify hazards and to estimate the risk;

(3) risk evaluation means a procedure based on the risk analysis to determine whether an acceptable level of risk has been achieved;

(4) risk assessment means the overall process comprising a risk analysis and a risk evaluation;

(5) safety means freedom from unacceptable risk of harm;

(6) risk management means the systematic application of management policies, procedures and practices to the tasks of analysing, evaluating and controlling risks;

(7) 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;

(8) actors means all parties which are, directly or through contractual arrangements, involved in the application of this Regulation;

(9) safety requirements means the safety characteristics (qualitative or quantitative) of a system and its operation (including operational rules) and maintenance necessary in order to meet legal or company safety targets;

(10) 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;

If there is no notified national rule for defining whether a change is significant or not in a Member State, the proposer shall consider the potential impact of the change in question 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.

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;

(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.

The proposer shall keep adequate documentation to justify its decision.

OJ L 191, 18.7.2008, p. 1 .

(11) proposer means one of the following:(a) a railway undertaking or an infrastructure manager which implements risk control measures in accordance with Article 4 of Directive 2004/49/EC;(b) an entity in charge of maintenance which implements measures in accordance with Article 14a(3) of Directive 2004/49/EC;(c) a contracting entity or a manufacturer which invites a notified body to apply the EC verification procedure in accordance with Article 18(1) of Directive 2008/57/EC or a designated body according to Article 17(3) of that Directive;(d) an applicant for an authorisation for the placing in service of structural sub-systems;

(a) a railway undertaking or an infrastructure manager which implements risk control measures in accordance with Article 4 of Directive 2004/49/EC;

(b) an entity in charge of maintenance which implements measures in accordance with Article 14a(3) of Directive 2004/49/EC;

(c) a contracting entity or a manufacturer which invites a notified body to apply the EC verification procedure in accordance with Article 18(1) of Directive 2008/57/EC or a designated body according to Article 17(3) of that Directive;

(d) an applicant for an authorisation for the placing in service of structural sub-systems;

(12) safety assessment report means the document containing the conclusions of the assessment performed by an assessment body on the system under assessment;

(13) hazard means a condition that could lead to an accident;

(14) 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;

(15) 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;

(16) 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;

(17) hazard identification means the process of finding, listing and characterising hazards;

(18) 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;

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

(20) 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;

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.

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.

OJ L 122, 11.5.2011, p. 22 .

(21) 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;

(22) 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;

(23) catastrophic consequence means fatalities and/or multiple severe injuries and/or major damage to the environment resulting from an accident;

(24) safety acceptance means status given to the change by the proposer based on the safety assessment report provided by the assessment body;

(25) 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;

(26) notified national rule means any national rule notified by Member States under Council Directive 96/48/ECOJ L 235, 17.9.1996, p. 6 . or, Directive 2001/16/EC of the European Parliament and of the CouncilOJ L 110, 20.4.2001, p. 1 . and Directives 2004/49/EC and 2008/57/EC;

(27) certification body means a certification body as defined in Article 3 of Regulation (EU) No 445/2011;

(28) conformity assessment body means a conformity assessment body as defined in Article 2 of Regulation (EC) No 765/2008;

(29) accreditation means accreditation as defined in Article 2 of Regulation (EC) No 765/2008;

(30) national accreditation body means a national accreditation body as defined in Article 2 of Regulation (EC) No 765/2008;

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 Union or national legislation, the proposer shall appoint its own assessment body at the earliest appropriate stage of the risk assessment process.

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.

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 Directive 2004/49/EC; and

(b) the conformity assessment carried out by a notified body as defined by Article 2(j) of Directive 2008/57/EC or a body designated in accordance with Article 17 of that Directive; and

Without prejudice to Union legislation, 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, as referred to in Articles 22(2) and 24(2) of Directive 2008/57/EC;

(b) a vehicle needs an additional authorisation for placing in service, as referred to in Articles 23(5) and 25(4) of Directive 2008/57/EC;

(c) the safety certificate has to be updated due to alteration of the type or extent of the operation, as referred to in Article 10(5) of Directive 2004/49/EC;

(d) the safety certificate has to be revised due to substantial changes to the safety regulatory framework, as referred to in Article 10(5) of Directive 2004/49/EC;

(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, as referred to in Article 11(2) of Directive 2004/49/EC;

(f) the safety authorisation has to be revised due to substantial changes to the safety regulatory framework, as referred to in Article 11(2) of Directive 2004/49/EC.

Where a significant change concerns a structural subsystem that needs an authorisation for placing in service as referred to in Article 15(1) or Article 20 of Directive 2008/57/EC, 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 a notified body in accordance with Article 18(2) of that Directive.

OJ L 218, 13.8.2008, p. 30 .

(31) 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).

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

(a) accredited by the national accreditation body referred to in Article 13(1) using the criteria defined in Annex II; or

(b) recognised by the recognition body referred to in Article 13(1) using the criteria defined in Annex II; or

OJ L 235, 17.9.1996, p. 6 .

When granting the safety certificate or the safety authorisation in accordance with Commission Regulation (EU) No 1158/2010OJ L 326, 10.12.2010, p. 11 . or Commission Regulation (EU) No 1169/2010OJ L 327, 11.12.2010, p. 13 . , a national safety authority shall accept accreditation or recognition by a Member State in accordance with Article 7, as proof of the ability of the railway undertaking or infrastructure manager to act as an assessment body.

When granting the certificate to an entity in charge of maintenance in accordance with Regulation (EU) No 445/2011, the certification body shall accept such accreditation or recognition by a Member State, as proof of the ability of the entity in charge of maintenance to act as assessment body.

OJ L 110, 20.4.2001, p. 1 .

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

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

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

(c) when the national safety authority is acting as certification body in conformity with Article 10 of Regulation (EU) No 445/2011, recognition by the national safety authority of the ability of an organisation or a part of it or an individual to conduct independent assessment through assessment and surveillance of the system of maintenance of an entity in charge of maintenance;

(d) recognition by a recognition body designated by the Member State of the ability of an entity in charge of maintenance, an organisation or a part of it or an individual to conduct independent assessment.

When the Member State recognises the national safety authority as an assessment body, it is the responsibility of that Member State to ensure that the national safety authority fulfills the requirements set out in Annex II; In this case, the assessment body functions of the national safety authority shall be demonstrably independent of the other functions of the national safety authority.

OJ L 326, 10.12.2010, p. 11 .

In the cases referred in Article 9(1)(a) and (d) and Article 9(2), the period of validity of recognition shall not exceed 5 years from the date it is granted.

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 theOJ L 153, 14.6.2007, p. 9 . and in an appropriate part of the safety authorisations;

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

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 harmonised format of certificates for entities in charge of maintenance provided in Annex V, or in Annex VI where relevant, of Regulation (EU) No 445/2011;

(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.

OJ L 327, 11.12.2010, p. 13 .

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.

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.

OJ L 153, 14.6.2007, p. 9 .

Where the risk assessment for a significant change is not to be mutually recognised, the proposer shall appoint an assessment body meeting at least the competency, independency and impartiality requirements of Annex II. The other requirements of paragraph 1 in Annex II may be relaxed in agreement with the national safety authority in a non-discriminatory way.

Where applicable, by no later than 21 May 2015 , Member States shall inform the Agency which is their national accreditation body and/or recognition body or recognition bodies for the purposes of this Regulation, as well as of the assessment bodies they recognised in conformity with Article 9(1)(a). They shall also notify any change to that situation within one month of the change. The Agency shall make this information publicly available.

By no later than 21 May 2015 , the national accreditation body shall inform the Agency of the assessment bodies accredited, as well as of the area of competence for which those assessment bodies are accredited as provided for in points 2 and 3 of Annex II. They shall also notify any change to that situation within 1 month of the change. The Agency shall make this information publicly available.

By no later than 21 May 2015 , the recognition body shall inform the Agency of the assessment bodies recognised, as well as of the area of competence for which those assessment bodies are recognised as provided for in points 2 and 3 of Annex II. They shall also notify any change to that situation within 1 month of the change. The Agency shall make this information publicly available.

The Agency shall organise peer evaluations between the recognition bodies based on the same principles as set out in Article 10 of Regulation (EC) No 765/2008.

The Agency shall organise, in collaboration with the European cooperation for Accreditation (EA), training on this Regulation for the national accreditation bodies and for the recognition bodies at least at each new revision of this Regulation.

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.

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.

Without prejudice to Article 16 of Directive 2008/57/EC, 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.

In the case referred to in point (a) of Article 2(3), in accordance with paragraph 5 of this Article, the declaration referred to in Article 16 shall be accepted by the notified 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.

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.

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.

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 Article 9 of Directive 2004/49/EC.

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 Article 14a(3) of Directive 2004/49/EC.

As part of the tasks defined in Article 16(2)(e) of Directive 2004/49/EC, 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 Regulation (EU) No 445/2011 but are identified in its National Vehicle Register.

As part of the tasks defined in Article 7(1) of Regulation (EU) No 445/2011, 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.

Each infrastructure manager and each railway undertaking shall, in its annual safety report referred to in Article 9(4) of Directive 2004/49/EC, 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.

Each national safety authority shall, in its annual safety report referred to in Article 18 of Directive 2004/49/EC, report on the experience of the proposers with the application of this Regulation, and, where appropriate, its own experience.

The annual maintenance report of entities in charge of maintenance of freight wagons referred to in point I(7)(4)(k) in Annex III to Regulation (EU) No 445/2011, shall include information about the experience of entities in charge of maintenance in applying this Regulation. The Agency shall gather this information in coordination with the respective certification bodies.

The other entities in charge of maintenance that do not fall within the scope of Regulation (EU) No 445/2011 shall also share their experience with the Agency on the application of this Regulation. The Agency shall coordinate the sharing of experience with these entities in charge of maintenance and with the national safety authorities.

The Agency shall collect all information on the experience of the application of this Regulation and shall, when necessary, make recommendations to the Commission with a view to improving this Regulation.

Before 21 May 2018 the Agency shall submit to the Commission a report containing:

(a) an analysis of the experience with the application of this Regulation, including cases where the CSM has been applied by proposers on a voluntary basis before the relevant date of application provided for in Article 20;

(b) an analysis of the experience of proposers concerning decisions on the level of significance of changes;

(d) an analysis of the experience with the accreditation and recognition of assessment bodies;

(e) an analysis of the overall effectiveness of this Regulation.

The national safety authorities shall support the Agency in collecting such information.

Regulation (EC) No 352/2009 is repealed with effect from 21 May 2015 .

References to the repealed Regulation shall be construed as references to this Regulation.

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 .

HAS ADOPTED THIS REGULATION: