European Railway Agency. Impact Assessment Report. Single Safety Certificate

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1 Impact Assessment Report Reference: ERA/EE/xxxxx Document type: Draft Version : 0.3 Date : Prepared by Reviewed by Approved by Name T. Holvad K. Davies, L. McDaid, B. Accou, T. Breyne A. Magnien Unit Economic Evaluation Unit Safety Unit Head of EE Unit Date & Signat. PAGE 1 OF 28

2 AMENDMENT RECORD Version Date Section number Modification/description Author All Structure of document + basic content All Additional text for all sections in document All General review + further evidence of possible impacts (section 7) TH TH, KD TH, KD PAGE 2 OF 28

3 SUMMARY OF FINDINGS Background The Agency is required under Article 10 (7) of Directive 2004/49/EC to review the development of safety certification and propose a strategy for how a single EU safety certificate might replace the current two part system (Part A/B). These proposals for moving to a single safety certificate have been considered as part of an impact assessment in order to inform the decision-makers about the possible consequences. Impact assessment results Overall, the focus of the impact assessment on introducing a single safety certificate valid across Europe has been on three key dimensions: Possible consequences on safety levels Implications on costs for the railway sector and the NSAs Implications on the competitiveness of the railway sector (notably with respect to other modes) We conclude that on safety the proposals should at least maintain safety levels and there could possibly be improvements. As for cost implications our analysis suggests that RUs are likely to have cost savings, notably those companies with operations in more than one country. NSAs may also experience cost savings due to elimination of part B safety certificates reducing the resources required for assessing applications. The cost savings identified are likely to support the competitiveness of the railway sector. For companies contemplating entering the railway market in different countries reduced safety certification cost may be one of the factors that strengthen the business case of such plans. This should therefore encourage further entry and contributing towards increased competition within the railway sector. As such we have also considered that the proposals put forward will not affect adversely SMEs and new entrants. On the contrary, a single EU safety certificate should strengthen the position of SMEs and new entrants. PAGE 3 OF 28

4 Consideration has also been given to implications on administrative burden. The finding is that there is in fact the possibility for reduced administrative burden On the basis of the available information it is likely that the benefits generated from introducing a single safety certificate are larger than the costs involved. As such this conclusion is considered robust even if trends towards increased international focus of railway transport in Europe is unexpectedly not materialising. PAGE 4 OF 28

5 Table of Contents SUMMARY OF FINDINGS INTRODUCTION Context Structure of document REFERENCES, TERMS AND ABBREVIATIONS Reference Documents Definitions and Terms PROBLEM DESCRIPTION Overview of safety certification framework Evidence on the functioning of current system Basis for EU action OBJECTIVES FOR A SINGLE SAFETY CERTIFICATE SCENARIOS / OPTIONS Overview of section Reference Scenario Alternative Scenario SUMMARY OF METHODOLOGY FOR IMPACT ANALYSIS General principles for assessment of impacts Data collection and analysis ASSESSMENT OF IMPACTS Overview of section Overview of expected impacts Administrative costs issues Quantitative analysis of impacts Competition assessment Robustness of results MONITORING AND EVALUATION PAGE 5 OF 28

6 8.1 Overview Monitoring prerequisites Monitoring efforts Monitoring results PAGE 6 OF 28

7 1. INTRODUCTION 1.1 Context The Agency is required under Article 10 (7) of Directive 2004/49/EC to review the development of safety certification and propose a strategy for how a single EU safety certificate might replace the current two part system (Part A/B). Further details regarding the proposed migration strategy are available in [2] and [5]. The Agency s final report to the Commission in February 2011 [2] sets out conclusions and a way forward for migrating to a single safety certificate. In [5] the Agency specifies its recommendation for a single safety certificate based on the earlier reports and the results of the external consultation in May 2011 and a workshop with stakeholders in June The Recommendation [5] for moving to a single safety certificate has been considered as part of an impact assessment in order to inform the decisionmakers about the options available and their consequences. As such, the outcome of the impact assessment is no pass / fail criterion for whether the Agency Recommendation should be taken forward or not The present document outlines the key findings of the impact assessment. Our approach for the impact assessment is structured in accordance with the EC Impact Assessment Guidelines [4] and the Agency general evaluation guidelines [3]. In particular, the work involves the following steps: Problem description Definition of objectives Specification of scenarios Analysis of impacts Monitoring and evaluation arrangements The impact assessment has been developed by ERA s Economic Evaluation Unit (EE) in conjunction with the ERA Safety Certification Sector. 1.2 Structure of document Overall, the IA report is structured as follows: References, terms and abbreviations used in this document are presented in Section 2 PAGE 7 OF 28

8 Section 3 describes the current and possible future problems experienced in the context of safety certification based on the current two part certificate approach. The basis for EU action in this area is also set out. In Section 4 specific objectives for the proposal regarding moving from the current two parts safety certificate (A and B) to a single safety certificate. The scenarios considered in the impact assessment are outlined in Section 5. The so-called reference scenario provides the benchmark against which the alternative (project) scenario has been assessed. Section 6 provides a summary of the methodology used for the impact analysis. In particular, the general principles are specified in Section 6.2 and the key stages of data collection and analysis are set out in Section 6.3. In Section 7 the results of the impact assessment for the proposals re. single safety certificate are presented. The section covers the following items: (1) overview of possible impacts for the different stakeholders; (2) administrative burden issues; (3) quantitative analysis of impacts; (4) competition assessment; (5) consideration to robustness of analysis. Section 8 provides an overview of plans regarding monitoring and evaluation. This covers the following elements: prerequisites, efforts and results. PAGE 8 OF 28

9 2. REFERENCES, TERMS AND ABBREVIATIONS 2.1 Reference Documents Ref. N Author Title Last Issue [1] EC Directive 2004/49 Safety Directive as amended by Directive 2008/110 [2] ERA Safety Unit The development of a migration strategy towards a single safety certificate [3] ERA Economic Evaluation Unit [4] European Commission Economic Evaluation: Methodology Guidelines 2007 Impact Assessment Guidelines. SEC(2009) [5] ERA Safety Unit Report to the Commission on the Recommendation for a single safety certificate 2011 [6] Interfleet Technology Report on Study into national safety requirements in Member States in relation to the award of Part B safety certificates Definitions and Terms Table 1 : Definitions and Terms Term Definition CBA CSM-CA CSM-RA ESG Cost-Benefit Analysis Common Safety Method on Conformity Assessment as provided for in Regulations (EU) No 1158/2010 and (EU) No 1169/2010. Common Safety Method on Risk Assessment as provided for in Regulation (EC) No 352/2009 on a common safety method on risk evaluation and assessment Economic Survey Group. The group has been set up by ERA and is managed by its Economic Evaluation Unit. ESG is considering the impact assessment work undertaken for the different recommendations of ERA, from the particular point of view of methodology (definition, usage and improvement) PAGE 9 OF 28

10 Table 1 : Definitions and Terms Term IM NSA RU Definition Infrastructure Manager (as defined in Article 3 of Directive 91/440/EEC) National Safety Authority (as defined in Directive 2004/49/EC) Railway Undertaking (as defined in Directive 2004/49/EC) SD Safety Directive (2004/49/EC) as amended by Directive 2008/110 SME Small and Medium sized Enterprises PAGE 10 OF 28

11 3. PROBLEM DESCRIPTION 3.1 Overview of safety certification framework In accordance with the Safety Directive 2004/49/EC [1] the safety certificate for RUs is issued following an assessment by the NSAs of the suitability of an RUs application to operate safely on the network. The purpose of the safety certificate is to provide evidence that the RU: has established its Safety Management System (SMS); and can therefore meet the requirements laid down in Technical Specifications for Interoperability (TSIs) and other Community legislation and in national safety rules in order to control the risks and operate safely on the network The SMS is an important tool because it sets out a harmonised way of managing safety performance and controlling risks, which can be accepted throughout Europe. It provides for the clear acceptance of responsibility by the RU/IM for the management of safety of their parts of the system through defined procedures to control risk and, where reasonably practicable, for continuous improvement of the system. The previous rule based system, used by many Member States, (and which continues in some Member States) relied on national requirements. Whilst cross acceptance of some rules is possible, not all can be accepted, making it difficult to have a fully open and competitive market. However, a rules based approach will work successfully as part of the SMS when it is clear who has the responsibility and how this is effectively managed. This is because compliance with rules alone may not be enough; it is necessary to ensure that the rules are used in a way that is relevant and appropriate to the activities of the RU/IM. If correctly applied, the SMS of the RU/IM can help to achieve this objective Importantly, the requirements for a SMS were introduced in Directive 2004/49/EC with the aim of having a pan European system, to remove the need for repetitive bureaucratic requirements and unnecessary PAGE 11 OF 28

12 national approvals and to provide a coherent approach to maintaining and developing safety performance in the EU The safety certificate has two parts: Part A is the acceptance of a RUs SMS as described in Article 9 and Annex III of Directive 2004/49/EC; and Part B is the acceptance of the provisions adopted by the RU to meet the specific requirements necessary for the safe operation of the relevant network as described in Annex IV of Directive 2004/49/EC. These cover compliance with network specific requirements for staff competence and management of rolling stock The Part A certificate is valid throughout Europe providing the type and extent of the operation has not changed (i.e. changing from freight to passenger services would probably require a revision). The Part B is relevant to the network where the RU operates. The Part B certificate is restricted to the RU s ability to comply with the requirements needed to operate on the specific network for which it is seeking a certificate by using the procedures it has established to obtain a Part A certificate. Importantly the Part B certificate should only cover the RUs ability to comply with network-specific: rules/competence/management of rolling stock. NSAs are required to accept the Part A certificate issued by a NSA in another Member State when the RU requests a Part B certificate in the new Member State. In such cases the NSA should not undertake further analysis or review of an accepted Part A but limit the assessment to the requirements of the CSM on Conformity Assessment (CSM-CA) as set out in Commission Regulation (EU) 1158/2010. This is to promote a single market for rail transport services through the development of a harmonised common regulatory framework. An RU will have one Part A but could have several Part Bs depending on it provides services. The CSM on Conformity Assessment sets out the legal boundary between the Part A and Part B definitively for the first time Since the Directive entered into force in 2004, two other important developments have taken place which influence the need for a Part B certificate. As set out in Paragraph 2.4, the Part B covers compliance with network specific requirements for competence and management of PAGE 12 OF 28

13 rolling stock and after the application of the generic SMS procedures (Part A). Directive 2007/59/EC on train driver licence and certification sets out the general professional knowledge and requirements regarding an EU wide licence. The Directive also sets out requirements for certification of drivers which covers the professional knowledge of rolling stock and infrastructure (route knowledge). These provisions aim to make it easier for drivers to move from one Member State to another and generally for both licences and complimentary certificates to be recognised by all railway stakeholders. Directive 2008/57/EC introduces new procedures for the authorisation of vehicles which are aimed at improving cross border operation by promoting the concept of mutual recognition of national rules covering the essential requirements. The principle being that Member States should not invoke national rules to impose unnecessary requirements, unless strictly necessary for verifying the technical compatibility of the vehicle with the relevant network. The technical compatibility of the vehicle with the relevant network should be done by through the authorisation process and the route capability through the RUs SMS, which makes the Part B certificate unnecessary. To this end national rules are being classified and compared in order to determine equivalence in terms of requirements, performance and safety. 3.2 Evidence on the functioning of current system A study was commissioned by the Agency, and undertaken by Interfleet Technology [6], with the aim of providing more information in relation to safety certification in Member States. They started the study in January 2010 and completed the report in early September One of the key findings from the study was that NSAs approached safety certification in different ways. There were some examples of good NSA practice, however in general the results were not positive. They reported that: There was no consistent assessment process to ensure that the NSA decisions were harmonised or at the least similar decisions were made in similar circumstances. PAGE 13 OF 28

14 The NSA resources and activities (including supervision) were not always targeted on those areas or operators who created the biggest risks. The NSA process or procedures were not always transparent, making it difficult for RUs to understand what was expected of them. Accountability (i.e. openness as required by Article 17 (1) of Directive 2004/29/EC) in their decision making was also often lacking. There were problems in the transparency and application of National Safety Rules Interfleet concluded that these concerns could only lead to lack of trust and a desire to check that everything was working with the potential for duplication, inconsistencies and confusion for RUs who are being asked for different requirements by different NSAs. However, they did state that the majority of NSAs did perform their activities often in difficult conditions and with little resources/competence and were sometimes handicapped by their lack of experience Further evidence on problems was identified in the impact assessment workshops that accompanied the work on the CSM-CA. The general conclusions from these workshops where almost all EU27 1 Member States participated (with the exception of Greece, Portugal and Romania) as well as Norway and Switzerland participated can be summarised as follows: There are different levels of understanding and application of the Safety Directive requirements amongst the participating MSs. This concerns problems in understanding and applying risk assessment requirements as well as differences amongst the NSAs on how the safety certification and authorisation regime is ensured and delivered in practice. As such this can generate mistrust among the different stakeholders. Lack of clarity or guidance for NSAs and RUs on the criteria to assess, evidence to provide (or search for) to comply with Part B requirements. Especially, uncertainty regarding the borderline between part A and B certificates was frequently mentioned. The migration from SCs issued previously in accordance to Directive 2001/14, to Part A and Part B Certificates compliant with 1 Cyprus and Malta were though not considered as they have no railways. PAGE 14 OF 28

15 Directive 2004/49 is not consistent amongst different MSs and in some cases may hamper business for some RUs which would like to operate in other MSs but cannot. There are differences amongst the NSAs on how to deal with this issue and how they consider 2001/14 SCs in relation to the possible equivalence to Part A SCs The scale and type of problems experienced is subject to country variation, with some Member States being rather advanced in terms of developing the safety certification process and substantial experience in assessing applications for safety certificates. Other countries face more basic challenges such as the practical implementation of the SD (defining the roles and responsibilities of the players NSAs/IMs/RUs), the development and full functioning of the NSA, and limited or missing experience in safety certification. The existence of these wide ranging practices across the EU countries is not likely to inspire the trust necessary by the NSAs in order to rely on others assessments. 3.3 Basis for EU action The formal legal basis for EU action is provided for in the Railway Safety Directive [1] with specific reference to Article 10 (7): Before 30 April 2009 the Agency shall evaluate the development of safety certification and submit a report to the Commission with recommendations on a strategy for migration towards a single Community safety certificate. The Commission shall take appropriate action following the recommendation In practice, a solution regarding current issues regarding recognised safety certification across Europe has per se only a European dimension rendering national based solutions not to be pertinent nor effective. PAGE 15 OF 28

16 4. OBJECTIVES FOR A SINGLE SAFETY CERTIFICATE One of the key aims of the Directive 2004/49/EC is to open up the rail market and make it more competitive, particularly against other modes of transport. Whilst a lot has been put in place since the Directive became law, the concern of lack of consistency in the application of Directive 2004/49/EC will continue to act as a barrier until a successful way forward can be obtained. It is clear that one of the aims of the Part A and Part B certification system was to be an interim measure until the Agency developed a suitable migration strategy towards a single EU certificate. It was never intended to be a permanent solution, but a means to allow Member States to gradually bring their systems into line and thereby have a simpler approach to open up access to the European networks for RUs. Indeed, a single safety certificate would be a tool to prevent safety arguments being unduly used by Member States in the safety certification process, resulting in the creation of barriers to the entry into the respective national markets by newcomers One of the key ways that both road and air work effectively within Europe is the acceptance of conformity (road) and harmonisation (air). There is no such single EU system for rail. In order for rail to start being as competitive as other modes, they need to have similar objectives and outcomes. A move to a single EU Certificate will help to achieve this by having a harmonised SMS which is accepted across Europe. This should also contribute towards reducing safety certification costs and avoiding duplicative assessment by NSAs. PAGE 16 OF 28

17 5. SCENARIOS / OPTIONS 5.1 Overview of section This section outlines the reference and alternative scenarios that together form the basis for the impact assessment. 5.2 Reference Scenario Essentially, the reference scenario would reflect the situation where a single safety certificate is not implemented. It should be emphasised that the reference scenario should reflect existing obligations on Member States regarding EU legislative measures. In particular, transposition of the Safety Directive should be assumed to be part of the reference scenario as the Member States were required to transpose it by 30 April 2006 at the latest. In this context, the reference scenario should be understood as the situation where all RUs have been issued with Part A + Part B (according to Directive 2004/49) as this reflects already agreed legal obligations. 5.3 Alternative Scenario The only alternative (project) scenario for this impact assessment will involve the case where a single safety certificate is introduced. As such this would facilitate assessment of the implications of having a single safety certificate compared to the situation where there continues to be the two part safety certificate (part A and part B). As put forward in the Recommendation the planned deadline for having the single safety certificate in place is This will also be the point in time used in our impact assessment. As far as possible within the available time other timings may be considered to ensure that 2020 is the optimal choice. PAGE 17 OF 28

18 6. SUMMARY OF METHODOLOGY FOR IMPACT ANALYSIS 6.1 General principles for assessment of impacts The impact assessment for considering the implications of a single safety certificate is based on the following principles (in accordance with established Agency practice): Comparison of the reference scenario (Do-nothing or Do-minimum) with one or several alternative scenarios (as outlined above); Assessment based on a cost-benefit analysis (CBA) perspective involving a consideration to the advantages and disadvantages generated relative to the reference scenario; Use of quantitative and qualitative analyses. Whenever possible quantitative information will be provided to supplement the qualitative considerations; Examination of main benefits and costs for different categories of stakeholders (e.g. railway undertakings, infrastructure managers, rail manufacturers, national safety authorities); Assessment of implications at European and country-specific level (or groups of countries); Competition assessment (including assessment of consequences for Small and Medium sized Enterprises, SMEs); Consideration to timing issues regarding speed of implementation; Consistent application of case study examples to illustrate potential consequences of moving to a single safety certificate; Analysis of robustness of key findings in order to ensure their validity. 6.2 Data collection and analysis The impact assessment is mainly formed on the basis of already available information. In the case of safety certification a number of relevant information sources exist including various reports / studies, evidence from workshops and bilateral meetings as well as the ERADIS PAGE 18 OF 28

19 database. In particular, the following would be of importance to include: Report on Study into national safety requirements in Member States in relation to the award of Part B safety certificates (Interfleet Technology, [2]) Agency workshop on single safety certificate Consultation responses regarding Agency proposals for moving to a single safety certificate IA workshops in the context of the preparation for the CSM-CA Recommendation NSA Peer Review on Part A Safety Certification Practices. Final Report Rail Liberalisation Index (country-specific sections) NSA Annual Safety Reports ERADIS Other information sources As a result it was decided not to issue any new questionnaires, although some interviews may be undertaken with selected stakeholders (notably RUs) to gather specific information about the costs of safety certification. The idea here is to interview different RUs to identify how the costs of safety certification vary according to different circumstances (e.g. type and scale of operations, extent of operations taking place in one or several countries, geographical location). Information about costs should consider part A only, part B only and part A and B together. The cost information concerns expenses incurred by the RU in preparing applications for a safety certificate. Information could also be collected on the fees charged by the NSA (although this information is available, see e.g. the 2011 Rail Liberalisation Index). Furthermore, it may also be relevant to collect details not only about costs but also the time involved. These interviews have not been completed so far and are planned to be finished for the final drafting of the impact assessment report Apart from the literature review and selected interviews the IA work will also utilise a number of case studies to examine how different PAGE 19 OF 28

20 railway undertakings are influenced by moving from a two part based safety certificate system to one based on a single safety certificate A key element in the analysis of the possible implications will look at two case studies: RU with activities in more than country RU with only domestic transport Cost implications for these of moving from two-parts safety certificate to single safety certificate will be estimated in order to determine whether for these case studies there are likely to be positive netbenefits. Subsequently, these (case study) estimates will be used to determine an order of magnitude for net-benefits at a European level. PAGE 20 OF 28

21 7. ASSESSMENT OF IMPACTS 7.1 Overview of section The findings regarding expected impacts from moving to a single safety certificate is presented in this section. Section 7.2 gives an overview of possible consequences concerning how impacts are likely to be incurred and the stakeholders affected. Administrative costs issues are discussed in 7.3, while 7.4 includes a quantitative analysis of the impacts. A competition assessment is briefly put forward with considerations regarding whether there are likely implications of the Recommendation on competition in the railway sector (Section 7.5). The importance of uncertainties in the assessment of impacts is examined in Section Overview of expected impacts The key stakeholders concerned of the proposal for a single safety certificate would be RUs that apply and are awarded safety certificates and NSAs that assess and award safety certificates Overall, the focus of the impact assessment on introducing a single safety certificate valid across Europe should be on three key dimensions: Possible consequences on safety levels Implications on costs for the railway sector and the NSAs Implications on the competitiveness of the railway sector (notably with respect to other modes) The possible consequences on safety levels have been raised as a concern in the consultation on the proposals. In particular, this refers to possible situations about RUs turning up and just operating. This concern is linked to broader issues regarding market opening and safety. However, it should be remarked that in [5] robust evidence regarding the lack of linkages between market opening and safety performance has been put forward. Furthermore, the proposals contain pertinent safeguards for the case of RUs turning up and just operating. As such the proposals envisage early interaction between the RUs with plans for starting operations on a given network and the relevant IM. In PAGE 21 OF 28

22 particular, one of the steps here is that the RU discusses and agrees any necessary risk control measures with the relevant IM. On this basis it can be expected that the proposals at least would maintain current safety levels. There may even be a positive impact on safety given the possibility for NSAs to have an increased focus on supervision activities rather than on assessment of safety certificate applications As for the possible implications on costs it is likely that the proposals would lead to a more efficient system where the costs of safety certification overall are lower for both RUs and NSAs. For domesticonly RUs the proposals will at least be neutral. If we assume that the costs of preparing and applying for a combined Part A and Part B safety certificate would be identical to the costs incurred in relation to a single EU safety certificate then an RU with only one Part B would be neutral. RUs operating in several EU countries and hence with more than one Part B safety certificate should essentially avoid the costs of additional Part B safety certificates if a single EU safety certificate is introduced. Additional cost savings for RUs are possible due to the elimination of the de facto possibility for NSAs in their assessment of part B safety certificate to reassess elements that have already been assessed (by another NSA) for the part A safety certificate. Available information suggests that currently there is indeed significant duplication when NSAs assess of part B safety certificate applications. The recent Agency organised workshop (in June 2011) on the issues regarding a single safety certificate highlighted that there are NSAs which in their assessment of part B safety certificate applications check elements that would be classified as belonging to the assessment of part A safety certificate applications. As such this clearly suggests the possibility for cost savings from avoiding duplication in safety certification As for NSAs there may also be cost savings due to the elimination of part B safety certificates possibly implying less resources required for assessment of safety certificate applications. These cost savings could be transferred to supervision activities. Overall, the proposals are likely to lead to cost savings for RUs and NSAs. The order of magnitude of these PAGE 22 OF 28

23 cost savings are likely to increase with trends going in the direction of RUs increasingly operate in more than one country The issue of implications on competitiveness of the railway sector is clearly linked to the possible implications on costs. As it appears the proposals are likely to result in reduced costs regarding safety certification. This should strengthen the competiveness of the railway sector. Furthermore, reduced cost of safety certification is likely to enhance the business case for companies to enter markets in other countries thereby contributing towards new entry and competition within the railway market Overall, these proposals are likely to result in benefits that significantly outweigh any costs. 7.3 Administrative costs issues As part of the impact assessment consideration has been given to the implications on administrative costs. This is based on the concepts put forward in the EC Impact Assessment Guidelines [4] where Annex 10 provide detailed information regarding administrative cost and administrative burden. In particular, administrative costs are defined as the costs incurred by enterprises, the voluntary sector, public authorities and citizens in meeting legal obligations to provide information on their action or production, either to public authorities or to private parties. Administrative burden concerns the part of the information collection and provision which is done solely because of a legal obligation (in contrast to those elements that would be done by entities even without the legislation) Overall, the proposals for a single safety certificate are unlikely to increase the administrative burden for railway undertakings since no fundamentally new obligations are imposed on them. Each RU will still have an SMS which forms the basis for the NSA granting a safety certificate. Once an RU starts operations it will have to undertake continuous monitoring of the SMS (this will be based on the CSM on monitoring when it enters into force). On the other hand with the EU safety certificate it will no longer have to apply for any additional (part B) safety certificates for operations in other countries. Instead the RU has to have discussions with the relevant IM prior to start operations; however this interaction is part of the requirements of the recast of PAGE 23 OF 28

24 the 1st railway package. Furthermore, this early interaction between RU and IM should not result in additional burden but rather ensure that the complete system works better while maintaining safety levels. On balance a single safety certificate should in fact reduce administrative burden for RUs due to avoidance of applying for more than one safety certificate As for NSAs the proposals do not imply new significant obligations either. They still have the obligations to assess and award safety certificates as appropriate, undertake supervision activities as well as take any enforcement action where they believe the safety performance of an RU is not sufficient (using the CSM on supervision). On the other hand there should overall be fewer applications for safety certificates across the EU with the removal of part B certificates. As such the number of safety certificates would be equal to the number of RUs in Europe at any given time. This should free up resources for the NSAs from assessment of applications for safety certificates. These resources could instead be allocated to ensure sufficient resources for the supervision activities. Overall, we would expect that the administrative burden should be reduced as the result of a move from two-part safety certificates to a single certificate. 7.4 Quantitative analysis of impacts The quantitative analysis will be based on the comparison of two case studies: Case study 1: An RU with operations in more than one country Case study 2: An RU with operations in one country only In Case Study 1 we would include RUs with one Part A safety certificate and more than 1 Part B safety certificate. This would refer to companies such as Hector Rail from Sweden. Hector Rail is a freight operator and provides services in Sweden, Denmark, Norway and Germany. If Hector Rail currently holds 4 Part B safety certificates (and one Part A) the introduction of a single EU safety certificate could result in cost savings equal to the costs associated with preparing and applying for 3 Part B safety certificates Estimates of the costs for RUs for preparing and applying for Part B safety certificates are included in the impact assessment report for the CSM on Conformity Assessment building on evidence from the UK. In particular, a cost of a Part B certificate is considered to be in the range PAGE 24 OF 28

25 from and Euros. These cost figures assume that the RU already has a Part A safety certificate and one Part B safety certificate. In the case of Hector Rail it could then with these cost estimates have savings of Euros over a 5 year period (the validity period of a safety certificate). These cost savings are derived under the assumption that a combined Part A+B certificate involves the same cost as a single EU certificate. Cost savings due to avoidance of duplication in the assessment of part B safety certificate applications involving checking part A elements are not included in these estimates. As one illustrative indication of the importance of this issue we note that in Germany the total fees charged to RUs for one typical safety certificate application apparently amount to at least 10,000 with no upper limit provided (this information was provided by ERFA during the Agency workshop on the single safety certificate in June 2011). The reason for no upper limit in possible total fees to be paid is due to the hourly based fee structure (100 per hour). The cost figures given will be validated further as part of the proposed interviews taking place in January As part of this we will also aim to identify further the possible cost savings due to avoiding duplicative assessment For case study 2 this could be an RU like Syntus bv in the Netherlands providing passenger services in the Eastern part of the country. Under the following assumptions the proposals would be cost neutral for this type of companies: (1) costs of preparing / applying for one combined Part A+B safety certificate is the same as the single EU safety certificate; (2) no changes in business activity (e.g. start of operations in other countries). 7.5 Competition assessment This section will consider the possible implications on competition within the railway sector. In particular, it will be examined whether the move to a single safety certificate will lead to disproportionately adverse effects on SMEs and new entrants It is not likely that introducing a single safety certificate will lead to adverse effects on SMEs and new entrants. On the contrary this change of the safety PAGE 25 OF 28

26 certification process could facilitate entry to the railway market in different countries. The main reason for this is that costs of safety certification for operating in more than one country should decrease (as discussed above). As such the safety certification process should become more transparent and easier to comprehend for RUs as it is no longer necessary to know up to 27 different processes but only one On this basis we expect that SMEs and new entrants should be positively affected by the move to a single safety certificate. 7.6 Robustness of results On the basis of the available information it is likely that the benefits generated from introducing a single safety certificate are larger than the costs involved. The size of the benefits will depend on how the European railway market will develop as our results suggest that: (1) RUs with significant activities in more than one country will benefit more than RUs whose services are domestic only; (2) if the number of countries an RU operates in increases it is likely that this would increase the benefits for such RUs of a single safety certificate (compared to the present two-part certificate) On a European level this would imply that if there is a trend towards RUs on average operating in an increasing number of countries this would lead to more benefits in comparison with a situation where the average number of countries an RU provides services stays at current levels. Current expectations for the European railway market are that further entry is likely together with increased share of international transport. This should imply that in the future a higher number of RUs will operate in more than one country and a larger share of these will work in an increasing number of countries. If these trends are fulfilled then overall benefits would be higher compared to trends implying a lower level of market entry and international orientation of RUs However, the available information suggests that domestic only RUs in the worst case would be neutral in terms of net-benefits from this proposal. Therefore, our conclusion that this proposal has positive net-benefits is robust to changes in trends for European rail transport regarding market opening. PAGE 26 OF 28

27 8. MONITORING AND EVALUATION 8.1 Overview According to the EC Impact Assessment Guidelines [4] ex-ante impact assessments should include consideration to the monitoring and evaluation arrangements to be put in place for adopted policy actions. These types of activities will facilitate the update of the impact assessment in the course of the preparation of proposals, or after their entry into force. Monitoring and evaluation should check three related elements: (1) prerequisites, (2) efforts and (3) results. Each of these is defined and outlined in the following paragraphs with reference to the proposals regarding a single safety certificate 8.2 Monitoring prerequisites Pre-requisites refer to issues that support the move to a single safety certificate and will have an influence on changes observed but are not part of the introduction of the single safety certificate itself. A number of these are mentioned in the Report on the Recommendation on a single safety certificate [5]. In particular, prerequisites to be monitored would concern: Implementation and application of CSM on risk evaluation and acceptance Implementation and application of the CSM on monitoring Implementation and application of the CSM on conformity assessment Implementation and application of the CSM on supervision 8.3 Monitoring efforts This is likely to be particularly concerned with the activities / findings of the proposed Programme Board. Monitoring would focus on are relevant project outcomes / deliverables defined, are the targets / milestones achieved and if not are alternatives / mitigating measures put in place. Particular attention should be given regarding the review of the Programme in 2015 and the planned review of the transition phase in 2016/17 as well as the final reporting in PAGE 27 OF 28

28 Monitoring regarding the required step change in behaviour with reference to NSAs and the sector is also included here. This should cover both whether the stakeholders strategic needs regarding assistance from the Agency are met and the extent to which there is step change in behaviour taking place. 8.4 Monitoring results This part of the monitoring should focus on the results of introducing a single safety certificate. It would be based on information gathering from the concerned stakeholders (NSAs, RUs and IMs) regarding their experiences, challenges of a single safety certificate etc As part of this there should also be monitoring of the possible changes in safety certification costs as well as the time involved. Furthermore, an assessment of the linkages between the single safety certificate and market entry could also be part of this activity. PAGE 28 OF 28

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