COMMISSION STAFF WORKING DOCUMENT EVALUATION Evaluation of the European Union Agency for Railways (ERA)
Date: 2025-11-07
Institutions: Directorate-General for Mobility and Transport, European Commission
Subjects: European Union Agency for Railways, operation of the Institutions, productivity, project evaluation, rail safety, rail transport, technical specification, telematics, trans-European network

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 7.11.2025  SWD(2025) 361 final  COMMISSION STAFF WORKING DOCUMENT  EVALUATION  Evaluation of the European Union Agency for Railways (ERA) {SWD(2025) 362 final}  
 
 
TABLE OF CONTENTS 

1. 

INTRODUCTION .................................................................................................................................. 1 

1.1 Context ............................................................................................................................... 1 

1.2 Purpose and scope of the evaluation ................................................................................... 4 

2.  WHAT WAS THE EXPECTED OUTCOME OF THE INTERVENTION? ........................................ 5 

2.1 Description of the intervention and its objectives .............................................................. 5 

2.1.1 Problem definition ................................................................................................. 5 

2.1.2 Objectives of intervention ..................................................................................... 7 

2.1.3 Activities, inputs and outcomes ............................................................................ 8 

2.2 Point of comparison .......................................................................................................... 10 

3.  HOW HAS THE SITUATION EVOLVED OVER THE EVALUATION PERIOD? ........................ 12 

3.1 Legal framework............................................................................................................... 12 

3.2 Provision of technical assistance ...................................................................................... 14 

3.3 Authority tasks .................................................................................................................. 17 

3.3.1 Vehicle authorisation ........................................................................................... 18 

3.3.2 Safety certification ............................................................................................... 24 

3.3.3 ERTMS Trackside Approvals ............................................................................ 27 

3.4 Removal of obsolete national rules .................................................................................. 27 

3.5 Cooperation with National Safety Authorities ................................................................. 30 

3.6 One-Stop-Shop (OSS) ...................................................................................................... 32 

3.7 Monitoring of National Safety Authorities ....................................................................... 33 

3.8 Monitoring of notified bodies ........................................................................................... 36 

4.  EVALUATION FINDINGS (ANALYTICAL PART) ........................................................................ 39 

4.1 To what extent was the intervention successful and why? ............................................... 39 

Effectiveness ................................................................................................................... 39 

Efficiency........................................................................................................................ 53 

Coherence ....................................................................................................................... 64 

4.2 How did the intervention make a difference and to whom? ............................................. 66 

EU added value .............................................................................................................. 66 

4.3 Is the intervention still relevant?....................................................................................... 69 

Relevance........................................................................................................................ 69 

5.  WHAT ARE THE CONCLUSIONS AND LESSONS LEARNED? .................................................. 71 

5.1 Conclusions ...................................................................................................................... 71 

 
 
 
 
5.2 Lessons learned ................................................................................................................ 77 

ANNEX I:  PROCEDURAL INFORMATION............................................................................................ 79 
ANNEX II. METHODOLOGY AND ANALYTICAL MODELS USED ................................................... 80 

ANNEX III. EVALUATION MATRIX AND, WHERE RELEVANT, DETAILS ON ANSWERS TO THE 
EVALUATION QUESTIONS (BY CRITERION) ...................................................................................... 91 

ANNEX  IV.  OVERVIEW  OF  BENEFITS  AND  COSTS  [AND,  WHERE  RELEVANT,  TABLE  ON 
SIMPLIFICATION AND BURDEN REDUCTION] ................................................................................ 114 
ANNEX V. STAKEHOLDERS CONSULTATION - SYNOPSIS REPORT ........................................... 117 

 
 
 
 
 
 
Glossary 

Term or acronym 

Meaning or definition 

AsBo 

ATO 

CER 

CSM 

Assessment Body 

Automatic Train Operation 

Community of European Railway and Infrastructure 
Companies 

Common Safety Method 

CSM ASLP 

Common Safety Method on Assessment of Safety 
Levels and Safety Performance 

CST 

CTT 

ECVVR 

EIM 

ERA 

ERADIS 

ERATV 

ERSAD 

ERTMS 

ETCS 

EVR 

FRMCS 

GSM-R 

Interoperability 

Common Safety Target 

Authorisations in conformity to type 

European Centralised Virtual Vehicle Register 

European Rail Infrastructure Managers (Association) 

European Union Agency for Railways 

European Railway Agency Database of 
Interoperability and Safety 

European Register of Authorised Types of Vehicles 

European Railway Station Accessibility Database 

European Rail Traffic Management System 

European Train Control System 

European Vehicle Register 

Future Railway Mobile Communication System 

Global System for Mobile Communications-Railway 

The ability of a rail system to allow the safe and 
uninterrupted movement of trains which accomplish 
the required levels of performance for these lines. 

NIB 

National Investigation Body 

 
 
 
NoBos 

NSA 

OPC 

OSS 

PCP 

RDD 

RINF 

SMS 

SMSS 

SPD 

SRD 

SSC 

UNIFE 

VA 

Notified conformity assessment bodies 

National Safety Authority 

Open Public Consultation 

One-Stop-shop  

Priority Country Programme 

Reference Document Database 

Register of Infrastructure 

Safety Management System 

Smart and Sustainable Mobility Strategy 

Single Programming Document 

Single Rules Database  

Single Safety Certificate 

Union of European Railway Industries 

Vehicle Authorisation 

TSI 

CCS TSI 

Energy TSI 

Infrastructure TSI 

LOC&PAS TSI 

Noise TSI 

OPE TSI 

Technical Specifications for Interoperability 

TSI relating to the Control Command and Signalling 
Subsystems 

TSI relating to the energy subsystem of the rail 
system 

TSI relating to the infrastructure subsystem of the rail 
system 

TSI relating to Locomotives and Passenger Rolling 
Stock 

TSI relating to the subsystem Rolling stock – noise 

TSI for Interoperability on Operation and Traffic 
Management 

 
 
 
 
PRM TSI 

SRT TSI 

TAF TSI 

TAP TSI 

WAG TSI 

TSI relating to accessibility for persons with 
disabilities and persons with reduced mobility  

TSI relating to safety in railway tunnels  

TSI relating to telematics applications for freight 

TSI relating to telematics applications for passengers  

TSI relating to the subsystem Rolling stock — Freight 
Wagons 

 
 
1. 

INTRODUCTION 

This report presents the findings of the evaluation pursuant to Article 82(1) and (2) of the 
Regulation (EU) 2016/796 of the European Parliament and of the Council of 11 May 2016 
on the European Union Agency for Railways and repealing Regulation (EC) No 881/2004 
(hereafter “the ERA Regulation”). Pursuant to Article 82(1), the Commission is required 
to evaluate the impact, effectiveness and efficiency of the Agency and its working practices 
and address any potential need to modify its mandate. Furthermore, Article 82(2) requires 
the Commission to assess the functioning of the dual system for vehicle authorisation and 
safety certification, the one-stop shop facilitating respective applications to ERA and the 
NSAs,  and  the  harmonised  implementation  of  European  Railway  Traffic  Management 
System (hereafter ERTMS) in the Union. While this evaluation formally constitutes the 
first evaluation of the Agency, it also fulfils the obligation set out under Article 82(4) to 
assess the results achieved by ERA in relation to its mandate, objectives, and tasks. 

1.1 CONTEXT  

The creation of an integrated European railway area called for harmonised safety rules and 
improved  technical  compatibility  of  infrastructure,  rolling  stock,  signalling,  as  well  as 
simpler procedures for approving rolling stock for use across the EU. The Agency, based 
in Valenciennes, France, was set up in 2004 as part of the 2nd Railway Package, by means 
of  Regulation  (EC)  No  881/2004  of  29  April  20041.  The  objective  of  ERA  was  to 
contribute, on technical matters, to the implementation of the Union legislation aimed at 
improving  the  competitive  position  of  the  railway  sector  by  enhancing  the  level  of 
interoperability of railway systems and at developing a common approach to safety on the 
European  railway  system,  to  contribute  to  creating  a  European  railway  area  without 
frontiers and guaranteeing a high level of safety. ERA was initially responsible for: 

•  developing, promoting and monitoring a common EU approach to safety management 

and governance across stakeholders, 

•  developing  the  common  technical  specifications  for  interoperability  (TSIs)  and 
common  safety  methods  and  targets  (CSMs  and  CSTs),  working  closely  with 
stakeholders  from  the  rail  sector,  national  authorities,  the  EU  institutions  and  other 
interested parties, 

•  organising and facilitating the exchange of information within the railway sector by 
networking  with  national  bodies,  providing  registers  and  databases,  issuing  reports, 
and giving guidance on the implementation of the regulatory framework. 

On 11 May 2016 the co-legislators agreed on a substantial extension of the role of ERA in 
a new basic act as part of the Technical Pillar of the 4th Railway Package2: Regulation (EU) 

1 OJ L 164, 30.4.2004, p.1. 
2 Regulation (EU) 2016/796 on the European Union Agency for Railways and repealing Regulation (EC) n° 
881/2004 

 
 
 
 
 
2016/796  on  the  European  Union  Agency  for  Railways  repealing  Regulation  (EC)  No 
881/2004. 

As of 16 June 2019, three years after the entry into force of the 4th Railway Package, ERA 
took over several responsibilities of National Safety Authorities (NSAs). It became the EU 
authority  responsible  for  issuing  authorisations  for  railway  rolling  stock  (locomotives, 
coaches  and  wagons)  for  national  or  EU-wide  use,  for  issuing  single  safety  certificates 
(SSCs)  for  railway  undertakings  operating  in  one  or  more  Member  States  and  for 
approving trackside projects of the ERTMS. According to the 4th Railway Package, the 
NSAs  remain  responsible  for  safety  authorisations  of  infrastructure  managers  and  the 
authorisation for placing in service of fixed installations relating to rail infrastructure and 
power supply. Applicants seeking to obtain SSCs or vehicle authorisations limited to the 
territory of one Member State, may address the request to the NSA of that Member State.   

In addition, the Agency is responsible for rail digitalisation, and it is the system authority 
for ERTMS (in practice train protection, radio communication and part of signalling) and 
separately,  system  authority  for  telematics  applications  (management  of  the  functional 
exchanges between the actors of the EU rail sector). Moreover, the Agency is the system 
authority for important rail registers, which it manages, such as the register of the EU rail 
infrastructure  (RINF),  the  EU  vehicle  register  (EVR),  the  register  for  vehicle  types 
(ERATV), and the register of rail safety-related entities and certificates (ERADIS).  

ERA’s  administrative  and  management  structure  comprises  an  Executive  Director,  a 
Management Board and an Executive Board3.  

The  Agency  is  managed  by  its  Executive  Director4,  which  is  accountable  to  the 
Management Board for his or her activities (see Section 4.1 for more information). The 
Executive Director is responsible for: 

•  day-to-day administration. 

• 

implementing decisions adopted by the Management Board. 

•  preparing and implementing programming documents. 

•  preparing consolidated annual activity reports.  

According to the ERA Regulation, the main role of the Management Board is to streamline 
the decision-making process in the Agency and contribute to enhancing its efficiency and 
effectiveness. It should give general orientations for the Agency's activities and be more 
closely involved in the monitoring of the Agency's activities, with a view to reinforcing 
supervision  on  administrative  and  budgetary  matters.  The  Management  Board  has  a 
supervisory  role  with  general  responsibility  for  budgetary  and  planning  matters;  the 
appointment of the Executive Director, the members of the Executive Board, the members 
of the Board(s) of Appeal and the reporting of the Agency's activities to EU institutions.  

Directive (EU) 2016/797 on the interoperability of the rail system within the European Union (Recast of 
Directive 2008/57/EC) 
Directive (EU) 2016/798 on railway safety (Recast of Directive 2004/49/EC) 
3 https://www.era.europa.eu/agency-you/management-executive-boards_en#oe-content-paragraph-462 
4 https://www.era.europa.eu/agency-you/agency/executive-director_en 

2 

 
 
The Management Board is composed of one representative of each Member State and two 
representatives of the Commission, all with the right to vote, each one with an alternate in 
case of absence. Norway participates as a Board member without a right to vote as it is one 
of  the  Member  States  of  the  European  Economic  Area  (EEA).  It  also  includes  six 
representatives, without a right to vote, of the railway sector at European level (i.e. Railway 
industry  (i.e.  railway  equipment 
undertakings,  Infrastructure  managers,  railway 
manufacturers)), trade-union organisations, passengers and freight customers, appointed 
by the Commission. All the Management Board members are appointed for a term of office 
of four years, which may be renewed. They are appointed as well as their alternates in the 
light  of  their  knowledge  of  the  Agency’s  core  business,  taking  into  account  relevant 
managerial, administrative and budgetary skills. 

At  the  practical  level,  the  Management  Board  adopts  the  programming  document 
containing annual and multi-annual programmes by 30 November each year, taking into 
account the opinion of the Commission. This is forwarded to the European Parliament, the 
Council and the Commission.  

to  be  adopted,  ensure  an  adequate  follow-up 

An Executive Board has also been set up to assist the Management Board by preparing the 
decisions 
the  findings  and 
recommendations  after investigations and the various internal  or external  audits. It  also 
supports  and  advises  the  Executive  Director  in  the  implementation  of  the  Management 
Board decisions, with a view to reinforcing supervision of administrative and budgetary 
management. 

to 

It  is  composed  by  the  following  Management  Board  members:  the  chairperson  of  the 
Management  Board  (acting  as  the  chairperson  of  the  Executive  Board),  four 
representatives  of  Member  States,  and  one  representative  of  the  Commission  in  the 
Management Board. The four representatives of the Member States are appointed by the 
Management Board on the basis of their relevant competence and experience. 

The Executive Board meets at least every three months and, where possible, not less than 
two weeks prior to the meeting of the Management Board. 

The  4th  Railway  Package  Steering  Group  is  a  subgroup  with  an  advisory  character  that 
developed proposals for improvements following the implementation of the 4th Railway 
Package. The six recommendations are: 

1)  Recommendation addressed to the Agency to establish two Advisory Groups for 
vehicle authorisation (VA) and Operations/single safety certification (SSC) and test 
their functioning  

2)  Recommendation addressed to the Agency on a short-list of subjects for testing the 

Advisory Groups  

3)  Recommendation addressed to the Agency a list of other subjects for discussing in 

the Advisory Groups  

4)  Recommendation addressed to the European Commission regarding cross-border 

agreements  

5)  Recommendation addressed to the Agency on the cooperation between ERA and 
NSAs  in  the  PoE  mandatory  part  6)  Recommendation  addressed  to  the  VA 
Advisory  Group  for  short  and  mid-term  solutions  for  reducing  standstill  for 
Conformity to type (CTT) authorisations in case of upgrading (e.g., of ERTMS) 

3 

 
These recommendations were endorsed by the Management Board of ERA under Decision 
n° 285, in January 20225. 

1.2 PURPOSE AND SCOPE OF THE EVALUATION  

Pursuant to Article 82(1) of the ERA Regulation, the Commission is required to evaluate 
the  impact,  effectiveness  and  efficiency  of  the  Agency  and  its  working  practices  and 
address any potential need to modify its mandate. The period under assessment is 2016–
2024, i.e. from the adoption of the technical pillar of the 4th Railway Package including 
ERA Regulation to mid-2024. A particular focus is on 2019–2024, the years when ERA’s 
new mandate was operational, even though the technical pillar of the 4th Railway Package 
was transposed in three phases: 16 June 2019, 16 June 2020, and 31 October 2020. Further 
details on timing of activities and limitations are set out in  Annex II. Moreover, Article 
82(2) requires  the Commission  to  assess the functioning  of the dual  system for vehicle 
authorisation and safety certification, the one-stop shop facilitating respective applications 
to ERA and the NSAs, and the harmonised implementation of ERTMS in the Union. While 
this evaluation formally constitutes the first evaluation of the Agency, it also fulfils the 
obligation set out under Article 82(4) to assess the results achieved by ERA in relation to 
its mandate, objectives, and tasks. 

More  specifically,  and  in  line  with  the  Better  Regulation  Guidelines,  this  evaluation 
analyses:   

•  under effectiveness, the extent to which ERA achieved its objectives,  

•  under efficiency, the use of actual resources relative to the results obtained,  

•  under internal coherence the compliance with the 4th railway package or other relevant 

legislation,  

• 

• 

for the EU added value, the impact beyond what reasonably could have been achieved 
by Member States and NSAs alone, and  

for  relevance,  whether  the  overall  problem  analysis  and  related  objectives  are  still 
adequate. 

The methodology used to carry out the evaluation was developed with the support of an 
external study and in line with the Better Regulation Guidelines and Toolbox6. It is detailed 
in Annex II of this report. An evaluation matrix (provided in Annex III of this report) was 
elaborated to answer the evaluation questions. It identified relevant operational questions, 
indicators, research tools and data sources.  

The following sources of information were used for this evaluation: 

• 

Information from the stakeholder consultation activities. These included an open public 
consultation (OPC), surveys, interviews, and targeted data requests. 

5 Microsoft Word - DECISION nÂ° 285 of the MB endorsing the recommendations of the 4RP SG following 
the implementation of the 4RP.docx 
6 https://commission.europa.eu/law/law-making-process/planning-and-proposing-law/better-
regulation/better-regulation-guidelines-and-toolbox_en 

4 

 
 
 
•  A  review  of  existing  literature  including  relevant  ERA  documents  such  as  Annual 

Activity Reports and Single Programming Documents (SPD), and  

•  Analysis of relevant ERA datasets. 

The limitations inherent to the methodology are: 

•  The study supporting this evaluation took place in a period when the implementation 
of  certain  key  aspects  of  the  4th  Railway  Package  was  still  incomplete,  due  to  the 
transposition in three phases: 16 June 2019, 16 June 2020, and 31 October 2020. 
•  This means that not all key aspects of the 4th Railway Package have been reflected; 
therefore, additional information had been gathered from ERA tools and documents. 
•  The learning curve of stakeholders to adjust to the changes and use all opportunities 
offered  under  the  4th  Railway  package  has  not  reached  its  peak  at  the  time  of  the 
evaluation  support  study,  meaning  that  cost  and time  saving  effects  might  not  have 
materialised before the finalisation of the support study. 
Insufficient quantitative data on costs of authorisation and certification for applicants, 
beyond the mere intervention of ERA and NSAs. 

• 

•  Limited detailed data on time and costs incurred to NSAs for processing applications. 

Nevertheless, despite the limitations, this evaluation gives a comprehensive  snapshot of 
the existing information and provides a consistent analysis of the implementation of ERA 
Regulation and how ERA fulfils its role.  

2.  WHAT WAS THE EXPECTED OUTCOME OF THE INTERVENTION7? 

2.1 DESCRIPTION OF THE INTERVENTION AND ITS OBJECTIVES 

2.1.1 Problem definition 

To understand the rationale and objectives of the ERA Regulation, it must be considered 
within the broader context of the 4th Railway Package. The Regulation forms part of the 
technical  pillar  adopted  in  April  2016,  alongside  Directive  (EU)  2016/797  on  the 
interoperability of the rail system within the European Union (Interoperability Directive) 
(Recast of Directive 2008/57/EC) and Directive (EU) 2016/798 on railway safety (Safety 
Directive)  (Recast  of  Directive  2004/49/EC).  Both  Directives  introduce  changes  to  the 
tasks and the internal organisation of the Agency, justifying the adoption of a new legal 
act  providing  for  the  establishment  and  tasks  of the  Agency  as  well  as  the  tasks  of  the 
Member States. One Impact Assessment was conducted in 2013, which accompanied all 
three legislative proposals8.  

The purpose and general  objective of ERA Regulation9 was to  contribute to  the further 
development and effective functioning of a single European railway area without frontiers, 
by guaranteeing a high level of railway safety and interoperability, while improving the 
competitive position of the railway sector.  

7 “Intervention” in the context of an Evaluation SWD means the Regulation being evaluated.  

8 https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2013:0008:FIN:EN:PDF  
9 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52013PC0027&qid=1733599037146  

5 

 
 
 
The  focus  of  the  ERA  Regulation10,  as  set  out  in  the  Explanatory  Memorandum  of  the 
Commission  proposal,  was  the  removal  of  the  remaining  administrative  and  technical 
barriers. This was to be done in particular by: (i) establishing a common approach to safety 
and interoperability rules to increase economies of scale for  railway undertakings active 
across  the  EU;  (ii)  decreasing  administrative  costs  and  accelerating  administrative 
procedures,  and  (iii)  avoiding  disguised  discrimination,  through  the  establishment  of  a 
European Union Agency for Railways. It  was intended to replace the original founding 
Regulation  and  to  add  new  important  tasks  to  the  Agency,  making  it  a  truly  European 
Railway Authority in the field of interoperability and safety. 

According  to  the  2013  Impact  Assessment  accompanying  the  proposals  for  the  ERA 
Regulation,  Interoperability  Directive  and  Safety  Directive11,  the  system  of  railway 
authorities  in  place  at  that  time,  while  intended  to  cater  for  the  remaining  technical 
differences between national railway systems, introduced barriers of different natures that 
contributed, among other factors, to a low degree of efficiency and competitiveness of the 
rail sector12. While in some Member States the national authorities functioned in general 
efficiently, in others the procedures which they managed were long and costly; this was 
partly linked to their inadequate resources. At the same time, the interoperability and safety 
requirements,  which  in  principle  should  have  been  aligned  by  common  EU  rules,  still 
diverged significantly at the national level. The latter obstacles hampered in particular the 
processes  leading  to  the  delivery  by  NSAs  of  the  safety  certificates  and  the  vehicle 
authorisations. Therefore, the existing system worked in a sub-optimal manner, and there 
was  room  for  improvement,  especially  regarding  the  operating  conditions  and 
administrative costs for railway undertakings.  

Based on the above, the key needs and problems identified at the time of the adoption of 
the 4th Railway Package are:  

•  Long  and  costly  authorisation  and  certification  procedures  hindering  the 
development  of  the  common  EU  railway  market  and  its  efficient  functioning.  This 
particularly affected new companies wishing to enter the market, thus contributing to 
a  low  level  of  competition  and  lasting  market  distortions.  As  far  as  the  vehicle 
authorisations issued by the NSAs are concerned, in a large majority of cases national 
legislation  required  additional  authorisations.  The  additional  authorisation  costs 
amounted to around EUR 1.6 million per vehicle13. The high costs and long duration 
of authorisation and certification contributed also to the slow uptake of innovation and 
modernisation of railway sector. 

•  Insufficient interoperability:  Various national rail networks had grown and evolved 
heterogeneously over time and relevant national technical and safety rules were put in 

10 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52013PC0027&qid=1733599037146  
11 https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2013:0008:FIN:EN:PDF  
12  To  be  noted  that  safety  levels,  as  such,  were  not  addressed  in  the  2013  Impact  Assessment  because, 
following  the  introduction  of  the  respective  railway  packages,  the  level  of  railway  safety  (measured  by 
indicators  like  number  of  accidents  and  fatalities)  has  had  gradually  increased.  Moreover,  the  rail  safety 
levels under each option assessed appeared to either remain the same given that the principal responsibilities 
of each main actor in the safety chain (predominantly Railway Undertakings and Infrastructure Managers) 
were not changed or could improve slightly as a result of more harmonised national legislation. 
13 ERA (2011), “Report on Railway Vehicle Authorisation”, quoted by the 2013 Impact Assessment. 

6 

 
 
place when no relevant  EU rules existed.  Even though Directive 2008/57/EC aimed 
among others at taking steps to avoid situations where Member States adopted new 
national rules or undertook projects increasing the diversity of the existing system, the 
experience  demonstrated  that  national  rules  still  represented  an  obstacle  to 
interoperability  within  the  Single  European  Rail  Area  (SERA),  as  well  as  a 
complication for new entrants, especially from other Member States. At the time of the 
2013 Impact Assessment, there were still more than 11 000 national rules in the EU.  

•  Access barriers for companies wishing to enter the railway market, in the form of 
diverging  and  untransparent  processes,  were  unable  to  prevent  arbitrary  and 
discriminative  decisions  by  NSAs.  The  approach  to  safety  certification  and  vehicle 
authorisation should have in principle allowed the free circulation of trains across the 
EU.  It  was  based  on  the  principle  of  mutual  acceptance  of  the  Part  A  certificate14 
regarding  the  Safety  Management  System  (SMS)  and  required  that  NSAs  work  at 
similar  level  of  performance.  The  reluctance  of  NSAs  to  accept  Part  A  certificates 
granted by other NSAs led to additional checks and increased time and cost burdens 
for rail operators. The new entrants were relatively more vulnerable to complexity and 
delay in procedures, since their human and financial resources were often limited. 

2.1.2 Objectives of intervention 

The general objective of the Agency, as expressed in Article 2 of the ERA Regulation, is 
to contribute to the further development and effective functioning of a  single European 
railway  area  without  frontiers,  by  guaranteeing  a  high  level  of  rail  safety  and 
interoperability,  while  improving  the  competitive  position  of  the  railway  sector”.  The 
specific objectives of the intervention are the following: 

•  Maintain a high level of railway safety and improve interoperability in the EU, 

•  Eliminate  operating  barriers  and  overcoming  the  fragmented  set  of  national 

frameworks and rules, 

•  Support  rail  sector  competitiveness  and  innovation  deployment  by  reducing 
administrative costs of authorisation processes, operating and running rail services and 
reducing time to market for innovation, 

•  Oversee  the  authorization  and  certification  processes  at  Union  level,  including 
placement in the market of railway vehicles and types, safety certification for railway 
undertakings, and approval of trackside equipment of ERTMS. 

The objectives of the intervention are in line with Sustainable Development Goal (SDG) 9 
which  covers  building  resilient  infrastructure,  promoting  inclusive  and  sustainable 
industrialisation  and  foster  innovation  as  well  as  SDG  11  on  making  cities  and  human 
settlements inclusive, safe, resilient and sustainable. Further, they contribute towards SDG 
13 (“Take urgent action to combat climate change and its impacts”). The intervention logic 
is presented in Figure 1. 

14 The Part A certificate demonstrates that the National Safety Authority has accepted the SMS of the railway 
undertaking. 

7 

 
 
 
Figure 1. Intervention Logic 

2.1.3 Activities, inputs and outcomes 

The  key  activities  associated  with  the  implementation  of  the  4th  Railway  Package  and 
related to the roles of the Agency as defined in chapters 2-8 of the ERA Regulation include 
both the process of development of the necessary new tools/mechanisms as well as their 
subsequent  operation  that  is  expected  to  lead  to  the  results.  They  also  cover  the 
management,  organisation,  human  resourcing,  monitoring/reporting  and  other  support 
mechanisms,  procedures  and  structures  –  as  defined  in  chapters  9-11  of  the  ERA 
Regulation – that are intended to ensure that ERA achieves its objectives in an effective 
and efficient manner.  

The intervention logic diagram also points to the role of inputs, in terms  of human and 
financial resources allocated to the Agency and the authorities and by the railway industry. 
For  the  Agency,  these  include  the  resources  coming  from  the  EU  budget  but  also  the 
fees/charges  for  the  approval  processes  and  other  chargeable  activities  that  support  the 
implementation.  Similarly,  national  authorities  (NSAs  and  ministries)  rely  on  national 
budgets  and  fees  charged  to  industry  or  to  ERA  for  the  support  required  in  delivering 
specific activities. For the railway industry, they refer to the relevant costs for obtaining 

8 

 
 
the necessary approvals using the new structures (through the fees paid but also time and 
other costs associated) and for the participation in other activities (e.g., working groups), 
where relevant. Capturing these is relevant when it comes to answering the questions on 
efficiency.  

The diagram then captures the expected immediate outputs of these activities, which in 
turn are expected to lead to results and impacts.  The expected results can be defined as 
follows: 

(1)  Achieve high level of technical, operational and safety harmonisation in the railway 

sector, 

(2)  Eliminate redundant national rules, 

(3)  Deliver a single information and communication system for all the applications across 

Europe, 

(4)  Reduce the cost and duration of the vehicle authorisation and safety certification, 

(5)  Ensure  consistent  development  of  telematics  and  ERTMS  deployment  and 

harmonised ERTMS technical solutions, 

(6)  Monitor performance and decision-making of notified bodies (NoBos) and NSAs, and 

(7)  Promote rapid deployment of innovation across the rail sector. 

In the longer term, the Agency activities were expected to lead to the following impacts: 

(1) A  more  competitive  rail  sector  performing  under  high,  harmonised  safety  and 

interoperability standards, and 

(2) Improved access to national markets for railway undertakings. 

External factors  

A series of external factors were expected to play a role and hence were considered during 
the evaluation: 

•  The EU policy context and priorities, including the Market Pillar of the 4th Railway 
Package but also broader EU policy priorities (e.g. those set by the European Green 
Deal, and the Smart and Sustainable Mobility Strategy (SSMS)), are to be considered 
when assessing whether the Agency objectives and activities remain relevant in this 
context.  

•  Both  market  and  technological  developments  in  the  sector  affect  the  demand  for 
Agency services (such as vehicle authorisations and safety certificates) and the need 
for adequate resources to respond on time and reduce  the time to market of railway 
innovation.  They  also  need  to  be  reflected  in  the  technical  support  activities  of  the 
Agency – including its own role and contribution to innovation related activities (such 
as Europe’s Rail Joint Undertaking (hereafter “EU-RAIL”)).  

•  Developments  at  Member  States’  level  including  relevant  national  policies,  NSAs’ 
activities, and relevant bilateral or multilateral agreements, as they can influence the 
effectiveness and EU added value of the ERA activities.  

9 

 
 
•  The  EU  Multiannual  Financial  Framework  sets  the  context  within  which  the  EU 
contribution to ERA is determined and hence, the resources available to the Agency to 
perform its tasks. In addition, the Common Approach on EU decentralised agencies15 
sets  certain  rules  concerning  the  operation  of  the  Agencies,  particularly  in 
organisational and monitoring terms.  

2.2 POINT OF COMPARISON  

The  main  point  of  comparison  for  this  evaluation  corresponds  to  the  expected  impacts 
identified in the 2013 Impact Assessment16 under the preferred policy option as compared 
to  the baseline.  The  preferred option  combines option 4  and the  horizontal elements of 
option  6,  while  the  baseline  assumes  the  continuation  of  sector  developments  in  the 
absence of the 4th Railway Package. More details are provided in Annex II. 

Table  1  below  presents  the  key  aspects  of  the  main  point  of  comparison  and  identifies 
relevant targets and benchmarks that have been used in the 2013 Impact Assessment to 
assess the performance of the Agency in the implementation of the 4th Railway Package.  

Table 1. Key aspects of the main point of comparison 

Key aspects of the main point 
of comparison 

Expected performance/target compared to the 2013 Impact 
Assessment baseline 

Authorisation and certification 
timescales and costs for 
applicants 

Impact on resources/costs for 
certification/ authorisation 
under new system 

Authorisation:   

•  Expected 24% reduction of average cost and 22% 
reduction of average time – from 12 to 9 months. 
• 
In addition: 25% reduction in time to market.  
•  Estimated authorisation cost savings for railway 

undertakings of EUR 235 million expressed as present 
value over 2015-2025 relative to the baseline.  

•  Additional opportunity costs savings of EUR 265 million 
for railway undertakings expressed as present value over 
2015-2025 relative to the baseline.  

Safety certification: 

•  Expected 19% reduction of average cost and 33% 

reduction of average time.  

ERTMS trackside approval 

•  No defined target as this is a new role. 
•  ERA to check that calls for tenders published in the case of 

individual deployment projects are in line with the 
ERTMS specifications. 

ERA 
55 additional full-time equivalents (FTEs) per year for 
authorisation/certification by 2020 (when all staff changes have 
been phased in)  
EUR 6.6 million annual increase in ERA budget by 2020 (when all 
staff changes have been phased in) covering staff and overheads. 
Expressed as present value over 2015-2025, the additional budget 
for ERA is estimated at EUR 44 million relative to the baseline.  

15https://european-union.europa.eu/document/download/d4199ff4-1e3d-45e6-af7e-
90cf1a7b10bc_en?filename=joint_statement_on_decentralised_agencies_en.pdf&prefLang=el 
16 https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2013:0008:FIN:EN:PDF  
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52013PC0027&qid=1732820854649  

10 

 
 
Key aspects of the main point 
of comparison 

Expected performance/target compared to the 2013 Impact 
Assessment baseline 

NSAs 
5 FTE per NSA average annual reduction for 
authorisation/certification, equivalent to EUR 0.55 million annual 
staff cost saving per NSA by 2020 (when all staff changes have 
been phased in). Expressed as present value over 2015-2025 
relative to the baseline, the total costs savings (for staff and 
overhead) for all NSAs are estimated at EUR 68 million.  

Expected reduction in the number of rules in cooperation with 
Member States but no set target for level of reduction to be 
achieved. 
Member States to be limited in the adoption of new rules to strictly 
defined cases. 

No specific performance target set in the Impact Assessment. 
ERA expected to monitor the performance and decision making of 
the NSAs, including the capacities (staffing, financial resources) of 
NSAs to execute tasks related with railway safety and 
interoperability, and effectiveness of their operations as regards 
monitoring of SMSs of railway. 

No specific performance target set in the impact assessment but 
positive impact from the supervision of NoBos by ERA giving 
greater confidence in NoBos outputs.  
Possible increase in costs for NoBos from audits. 

No specific target or level of performance set.  
It can be derived that Agency role and capacity will be 
strengthened, that work on TSI development will continue and that 
TSIs will be adopted more broadly in a harmonised way and in the 
place of applicable national rules.  

No specific targets set but expectation/requirement that appropriate 
information tools/registers are in place to support delivery 
authorisation/certification activities and screening/elimination of 
national rules.  

Evolution of national rules on 
safety and interoperability 

Monitoring of NSAs 

Monitoring of NoBos 

Technical support/ 
recommendations on railway 
safety and interoperability/ TSI 
development 

Datasets/registers  

ERA internal capacity/ 
resources/ management 
structures and procedures 

Strengthened capacity of the Agency assumed (in terms of 
resources/expertise) to be able to deliver on the new roles and 
responsibilities. 

Impacts on safety and 
interoperability 

Impacts on rail freight market, 
prices, service levels and rail 
investments 

Enhanced level of interoperability of the basis of the adoption of the 
elimination of national rules incompatible with TSIs and CSMs. 
Rail safety levels under each option to remain the same or improve 
slightly as a result of more harmonised national legislation. 

Expected increased number of market entrants due to the reduction 
of costs and removal/reduction of restrictions linked to national 
rules (effect to be greater in countries with higher level of 
restrictions).  
Indirect positive impact on rail freight prices, service levels and rail 
investments triggered by the changes in rail market structure 
(increased market entry) and reduced authorisation/opportunity 
costs.  

The  expected  cost  impacts  of  the  2013  Impact  Assessment  were  based  on  several 

11 

 
 
 
 
 
assumptions regarding the level of authorisation or certification activity which have proven 
to underestimate the actual level of activity. Moreover, the cost assumptions concerning 
the authorisation or certification procedures are not comparable with the actual processes 
and  approach  adopted.  First,  the  volume  of  work  performed  by  ERA  is  higher  than 
anticipated in the 2013 Impact Assessment. Second, the work NSAs have to do for ERA 
authorisations  is  more  extensive  and  thus,  more  costly  than  originally  expected. 
Nevertheless,  the  2013  Impact  Assessment  estimations  remain  useful  for  comparison 
purposes. 

The 2013 Impact Assessment had also some limitations. It lacked quantitative benchmarks 
for other parts of the implementation of the 4th Railway Package and provided a relatively 
brief qualitative description of the expected impacts. In some areas there was no explicit 
mention  of  the  expected  performance,  but  it  is  possible  to  derive  the  expected  impacts 
based on the Impact Assessment and ERA Regulation. The 2013 Impact Assessment also 
included a description of the implementation scenario for the preferred policy option and 
identified several risk parameters and factors that could be detrimental to the successful 
delivery  of  the  intervention  and  achievement  of  the  objectives  set.  The  risk  factors 
identified in the 2013 Impact Assessment remain relevant when considering the parameters 
that  actually  have  affected  the  performance  of  the  Agency  and  provide  explanation  for 
possible deviations. 

3.  HOW HAS THE SITUATION EVOLVED OVER THE EVALUATION PERIOD? 

3.1 LEGAL FRAMEWORK 

The adoption of the technical pillar of the 4th Railway Package in 2016 brought significant 
changes  to  the  roles  and  responsibilities  of  the  Agency.  However,  before  the  new 
legislative  framework  became  fully  effective  and  ERA  could  take  up  its  new  tasks, 
preparatory work was needed to adopt the necessary secondary legislation and establish 
new tools and working procedures.   

The  Rail  Safety  and  Interoperability  Directives  of  the  4th  Railway  Package  provided 
Member  States  with  a  choice  of  two  transposition  deadlines  –  16  June  2019,  or,  upon 
notification to the Commission and ERA, 16 June 2020. Further, as part of the emergency 
measures  adopted  by  the  Commission  in  reaction  to  the  COVID-19  outbreak  and  in 
response to Member States’ requests, an additional transposition deadline of 31 October 
2020  was  introduced.  As  a  result,  the  technical  pillar  of  the  4th  Railway  Package  was 
transposed by the Member States in three phases17. 

Eight Member States started applying the 4th Railway Package on 16 July 2019, therefore 
ERA had to finish all preparatory work before that date, to be able to receive and process 
first applications already on that date. This included developing a plan with all necessary 
deliverables  clustered  into  projects  and  setting  up  an  internal  structure  to  manage  the 
project  portfolio.  The  overall  progress  was  monitored  by  the  Agency’s  management  as 

17 Transposition Interoperability Directive:  
https://eur-lex.europa.eu/legal-content/EN/NIM/?uri=CELEX:32016L0797 
Transposition Safety Directive: https://eur-lex.europa.eu/legal-content/EN/NIM/?uri=CELEX:32016L0798 

12 

 
 
well as by the 4th Railway Package Steering Group that was established at the level of ERA 
Management Board and composed of representatives of different stakeholders18.  

Based on formal recommendations as well as on various inputs provided by ERA, between 
2017 and 2019 the Commission adopted 14 legislative acts which laid the ground for  a 
smooth implementation of the new roles of the Agency, in particular the roll-out of the 
dual system19 of vehicle authorisation and safety certification (Table 2). In parallel, ERA 
prepared and adopted its internal procedures and deployed first versions of necessary IT 
tools. 

Table  2.  List  of  secondary  legislation  adopted  from  2017  to  2019  in  preparation  for  the 
application of the technical pillar of the 4th Railway Package 

Year 

Legislation 

2017  −  Commission Delegated Decision (EU) 2017/1474 of 8 June 2017 supplementing Directive 
(EU)  2016/797  of  the  European  Parliament  and  of  the  Council  with  regard  to  specific 
objectives for the drafting, adoption and review of technical specifications for interoperability 

2018  −  Commission Implementing Regulation (EU) 2018/545 of 4 April 2018 establishing practical 
arrangements  for  the  railway  vehicle  authorisation  and  railway  vehicle  type  authorisation 
process pursuant to Directive (EU) 2016/797 of the European Parliament and of the Council 

−  Commission Delegated Regulation (EU) 2018/761 of 16 February 2018 establishing common 
safety methods for supervision by national safety authorities after the issue of a single safety 
certificate  or  a  safety  authorisation  pursuant  to  Directive  (EU)  2016/798  of  the  European 
Parliament and of the Council and repealing Commission Regulation (EU) No 1077/2012 

−  Commission Delegated Regulation (EU)  2018/762 of 8 March 2018 establishing common 
safety  methods  on  safety  management  system  requirements  pursuant  to  Directive  (EU) 
2016/798  of  the  European  Parliament  and  of  the  Council  and  repealing  Commission 
Regulations (EU) No 1158/2010 and (EU) No 1169/2010 

−  Commission Implementing Regulation (EU) 2018/763 of 9 April 2018 establishing practical 
arrangements  for  issuing  single  safety  certificates  to  railway  undertakings  pursuant  to 
Directive  (EU)  2016/798  of  the  European  Parliament  and  of  the  Council,  and  repealing 
Commission Regulation (EC) No 653/2007  

−  Commission Implementing Regulation (EU) 2018/764 of 2 May 2018 on the fees and charges 
payable to the European Union Agency for Railways and their conditions of payment 

−  Commission Implementing Regulation (EU) 2018/867 of 13 June 2018 laying down the rules 

of procedure of the Board(s) of Appeal of the European Union Agency for Railways 

2019  −  Commission Implementing Regulation (EU) 2019/250 of 12 February 2019 on the templates 
for EC declarations and certificates for railway interoperability constituents and subsystems, 
on the model of declaration of conformity to an authorised railway vehicle type and on the 
EC verification procedures for subsystems in accordance with Directive (EU) 2016/797 of 
the European Parliament and of the Council and repealing Commission Regulation (EU) No 
201/2011 

−  Commission Implementing Regulation (EU) 2019/772 of 16 May 2019 amending Regulation 
(EU)  No  1300/2014  as  regards  inventory  of  assets  with  a  view  to  identifying  barriers  to 
accessibility,  providing  information  to  users  and  monitoring  and  evaluating  progress  on 
accessibility 

−  Commission Implementing Regulation (EU) 2019/775 of 16 May 2019 amending Regulation 

(EU) No 454/2011 as regards Change Control Management 

18 4th Railway Package Readiness Assurance Terms of Reference, adopted by ERA Management Board at 
the meeting on 26 September 2017. 
19 In the case of operations in more than one Member State, the Agency is the authorising entity. Otherwise, 
the applicant can choose whether to apply to the Agency or to the relevant NSA. 

13 

 
 
Year 

Legislation 

−  Commission  Implementing  Regulation  (EU)  2019/776  of  16  May  2019  amending 
Commission Regulations (EU) No 321/2013, (EU) No 1299/2014, (EU) No 1301/2014, (EU) 
No  1302/2014,  (EU)  No  1303/2014  and  (EU)  2016/919  and  Commission  Implementing 
Decision  2011/665/EU  as  regards  the  alignment  with  Directive  (EU)  2016/797  of  the 
European Parliament and of the Council and the implementation of specific objectives set out 
in Commission Delegated Decision (EU) 2017/1474 

−  Commission  Implementing  Regulation  (EU)  2019/777  of  16  May  2019  on  the  common 
specifications for the register of railway infrastructure and repealing Implementing Decision 
2014/880/EU 

−  Commission Implementing Regulation (EU) 2019/778 of 16 May 2019 amending Regulation 

(EU) No 1305/2014 as regards Change Control Management  

−  Commission Implementing Regulation (EU) 2019/779 of 16 May 2019 laying down detailed 
provisions  on  a  system  of  certification  of  entities  in  charge  of  maintenance  of  vehicles 
pursuant  to  Directive  (EU)  2016/798  of  the  European  Parliament  and  of  the  Council  and 
repealing Commission Regulation (EU) No 445/2011 

Source: Ricardo (2023) Evaluation support study 

3.2 PROVISION OF TECHNICAL ASSISTANCE 

Compared to its previous mandate, the 4th Railway Package brought limited changes to 
ERA’s role in supporting the Commission and the Member States with technical assistance 
to improve the interoperability of the European railway systems and its safety.  

The  Technical  Specifications  for  Interoperability  (TSIs)  define  the  technical  and 
operational standards which must be met by each subsystem20 or part of subsystem in order 
to meet the essential requirements and ensure the interoperability of the railway system of 
the European Union. The essential requirements can be summarised as safety, reliability 
technical  compatibility  and 
and  availability,  health,  environmental  protection, 
accessibility. Article 5(2) of the Interoperability Directive provides for the  Commission 
requesting  the  Agency  to  draft  TSIs  and  amendments  thereto  and  make  the  relevant 
recommendations  to  the  Commission.  The  ERA  working  method  to  issue  TSI 
recommendations is presented in Figure 2. 

20 Directive (EU) 2016/797 defines the subsystems, either structural or functional, forming part of the railway 
system of the European Union.  

14 

 
 
Figure 2. ERA Working method for issuing TSIs recommendations 

Since June 2016, two major TSI revisions cycles took place. In addition, and following 
extensive stakeholder consultations, the request to the Agency for recommendations for 
future  TSI  revisions  was  made  in  August  2024,  outlining  a  multiannual  plan  for  the 
upcoming TSI revision cycles until 2030 to prepare TSIs for new technologies, to close 
open points where national rules may still be possible or add areas inadequately covered 
in previous versions of TSI. 

In 2019 all TSIs were revised21 and brought in line with the 4th Railway Package, only OPE 
TSI underwent a deeper revision at this stage.  

In 2023 eight TSIs22 were revised with a view of achieving higher levels of interoperability: 
CCS  TSI  was  recast,  while  TSIs  LOC&PAS,  WAG,  OPE,  INF,  ENE  and  PRM  were 
amended. Figure 3 summarises the specific cases and open points remaining after these 
revisions.  One  of  the  open  points  concerns  TSI  Noise  (Noise  of  parked  trains),  which 
should  be  part  of  the  new  TSI  request  to  be  included  in  the  TSI  Revision  following  a 
respective recommendation by the Agency in 2028. 

21  A  chronology  table  for  all  TSIs  can  be  found  at  https://www.era.europa.eu/system/files/2022-
10/TSIs%20chronology%20table.pdf?t=1718972267. It includes details on the Commission Implementing 
Regulation that updated one or multiple TSIs. 
22 TSI relating to the Control Command and Signalling Subsystems (CCS TSI), TSI relating to Locomotives 
and Passenger Rolling Stock (LOC&PAS TSI), TSI relating to the infrastructure subsystem of the rail system 
(INF TSI), TSI relating to the energy subsystem of the rail system (ENE TSI), TSI relating to accessibility 
for persons with disabilities and persons with reduced mobility (PRM TSI); TSI relating to the subsystem 
Rolling stock — Freight Wagons (WAG TSI), TSI for Interoperability on Operation and Traffic Management 
(TSI OPE). 

15 

 
 
 
Figure 3. Specific cases and open points per TSI as of 30 June 2024 

Source: ERA 

Further,  under  Article  6(2)  of  the  ERA  Regulation,  the  Agency  is  tasked  to  issue 
recommendations to the Commission concerning the CSMs23. These methods describe how 
the  safety  levels,  the  achievement  of  safety  targets  and  compliance  with  other  safety 
requirements should be fulfilled. Currently, there are five CSMs which cover requirements 
for  SMSs,  monitoring,  supervision,  risk  assessment  and  assessment  of  safety  targets. 
Further, two CSMs on conformity assessment remain temporarily in force until 30 October 
2025 when last certificates issued based on these requirements will expire.  

In January 2019 ERA received a mandate from the Commission to draft a recommendation 
for a new CSM concerning the Assessment of Safety Levels and Safety Performance of 
railway operators at national and Union level (CSM ASLP), building on results of earlier 
work of the Agency performed under Article 18 of the ERA Regulation on exchange of 
information  on  safety-related  accidents.  On  that  basis,  ERA  analysed  the  possibility  of 
introducing  a  system  for  reporting  occurrences,  which  would  facilitate  the  exchange  of 
information on accidents and their causes between relevant actors. The recommendation 
for the CSM ASLP was presented by the Agency to the Commission in 2021 and it was 
accompanied by an impact assessment24. The Commission Delegated Regulation on CSM 
ASLP has not yet been adopted. Its adoption (estimated for 2026) aims to support railway 
safety by providing a preventive framework for addressing accidents and their causes.  

In addition to recommendations, the Agency has also developed opinions, which are non-
binding  acts  providing  specialised  expertise  on  railway  issues  to  decision-makers, 
including the European  Commission,  National  Regulatory Bodies or Member States. A 
total  of  78  opinions25  have  been  provided  by  the  Agency  since  the  adoption  of  the  4th 
Railway Package.  

23 The current structure of CSMs was introduced in 2018, following their latest partial revision. Based on a 
mandate  from  2014  (updated  in  2016  to  reflect  the  new  legal  basis),  the  Agency  has  issued  in  2017  a 
recommendation covering two CSMs: on safety management systems and supervision. 
24 Impact Assessment (2).pdf  
25https://www.era.europa.eu/library/documents-regulations/opinions-and-technical-
advices?f%5B0%5D=lp_opitecha_title%3AOpinion  

16 

 
 
 
ERA is also required to provide technical advice on matters requiring specific knowledge 
and  collecting  information  through  networks.  Technical  advice  mainly  regarding 
interoperability  was  provided  on  24  occasions26  since  the  adoption  of  the  4th  Railway 
Package.  Finally,  ERA  Regulation  also  introduced  the  requirement  for  an  impact 
assessment of recommendations and opinions. Depending on the nature of the change, the 
Agency  may  sometimes  conduct  a  light  impact  assessment  instead  of  a  full  impact 
assessment.  

3.3 AUTHORITY27 TASKS 

Authority tasks of the Agency are related to safety certification for railway undertakings, 
vehicle authorisation and ERTMS trackside approval.   

The  Agency  started  delivering  authority  tasks  on  16  July  2019,  and  ERA’s  new  role 
became fully applicable  in all Member States at the end of October 2020  when the last 
deadline for transposition of the technical pillar of the 4th Railway Package passed. The 
volume of work related to the new authority tasks increased over time and especially since 
October 2020. Figure 4 presents the total number of application decisions issued by ERA 
since 2019 and the respective vehicles authorised; the steady uptake of the workload of 
ERA  until  it  fully  took  up  the  relevant  roles  is  apparent.  The  figure  shows  the  gradual 
increase in  ERA’s workload after 2021, which was the first  full year when the Agency 
authority role was applicable in all Member States. 

Despite the increasing workload, all decisions have been taken within the deadline set in 
the legal framework taking into account any time freeze agreed with the applicants28. 

Figure 4. Number of decisions issued by the Agency for authority tasks (June 2019  - June 
2024) 

Source:  ERA –  One-Stop  Shop.  Note:  VA  stands  for  Vehicle  Authorisation;  SSC  stands  for  Single  Safety 
Certificate and TA stands for ERTMS trackside approval 

26https://www.era.europa.eu/library/documents-regulations/opinions-and-technical-
advices?f%5B0%5D=lp_opitecha_title%3Aadvice  
27 Where provided for by the Safety and the Interoperability Directives, the Agency shall perform the role of 
Union authority responsible for issuing authorisations for the placing on the market of railway vehicles and 
vehicle types and for issuing single safety certificates for railway undertakings. Further, ERA shall act as the 
system  authority  to  ensure  the  coordinated  development  of  telematics  applications,  system  authority  for 
ERTMS, as well as for all registers and databases referred to in  the Safety Directive and Interoperability 
Directive.  
28 Annual Activity Reports of the Agency, 2019-2023. 

17 

 
 
 
3.3.1 Vehicle authorisation  

Any new or significantly modified railway vehicle must be authorised before operating on 
the EU railway network. An authorisation is valid for a defined area of use, i.e. a network 
or networks within one or more Member States. If the area of use is limited to a network 
or networks within one Member State, the applicant can submit the application for vehicle 
authorisation either to the NSA or to ERA. In case of vehicles having an area of use in 
more than one Member State, ERA is always the issuing authority. 

Two main categories of vehicle authorisations can be distinguished:  

•  authorisations pertaining to a new vehicle design – normally the first in class, which 
are complex and require the complete assessment of the vehicle’s design against the 
applicable requirements,  

•  authorisations in conformity to type (CTT), provided to individual vehicles conforming 
to an already authorised type. The process involves simple administrative checks and 
can be finalised in a couple of days. 

These two processes also apply to significant changes to existing vehicles and types - in 
practice the source of much of the work of ERA. Until end of June 2024, the Agency has 
delivered  decisions  in  7  536  applications  for  vehicle  authorisation  which  included  710 
applications for type authorisations and 6 826 applications for CTT (Table 3). In the same 
period, the NSAs processed over 4 900 applications, i.e. around 2 500 applications less 
than ERA.  

Table 3. Number of vehicle authorisations delivered by ERA and NSAs between June 2019 
and June 2024 

Authorisation in 
conformity to type 

Type authorisations 

Total 

Source: ERA - One-Stop Shop 

ERA 

6 826 

710 

7 536 

NSAs 

3 952 

1 010 

4 962 

The number of applications received every year by ERA and NSAs was rising sharply until 
2022 and stabilised in 2023 at a level of around 3 200 decisions (Figure 5). A similar or 
slightly higher number can be expected in 2024 assuming the tendency from the first half 
of 2024 is kept.  

Overall,  after  five  years  of  operation  as  an  authorisation  entity,  the  Agency  processed 
60.3%  of  all  vehicle  authorisation  applications  registered  in  the  One-Stop  Shop  (OSS). 
This  share remains  relatively  stable  throughout the years with  a  maximum  of 67.8% in 
2020, when however not all Member States  were yet  included in  the new authorisation 
system.  

18 

 
 
Figure 5. Number of vehicle authorisation decisions issued by ERA and NSAs (June 2019 - 
June 2024) 

Source: ERA – One-Stop Shop 

Vehicle authorisations (VA) are categorised according to cases which are listed in Article 
14  of  Implementing  Regulation  (EU)  2018/54529.  Authorisations  in  conformity  to  type 
constitute the largest group which dominates the work of both ERA and the NSAs; they 
account for 90.6% of VA workload of the Agency and 79.7% of VA workload of NSAs. 
For  other  types  of  applications,  the  differences  between  ERA  and  NSAs  become  more 
visible. The Agency processes 71% of all applications linked to an extension of area of use 
of  railway  vehicles  and  52.5%  of  cases  when  a  new  authorisation  is  combined  with  an 
extension of area of use. On the other hand, NSAs process 71.2% of applications for new 
and first authorisations and ERA 64.4% (Figure 6). 

Figure 6. Structure of all vehicle authorisation applications by authorisation case (June 2019 
– June 2024) 

Source: One-Stop Shop data 

This distribution of work between ERA and NSAs is driven by two important factors: the 
expected area of use of a vehicle and its type (locomotive, trainset, special vehicle, wagon 
or coach).  

29 When a first vehicle of a certain design is authorised, a vehicle type authorisation is granted at the same 
time (‘first authorisation’). Throughout its life cycle, changes can be introduced to the vehicle which when 
meet certain thresholds trigger a need for a ‘new authorisation’. It is also possible to receive an authorisation 
extending area of use of an existing vehicle not subject to any changes to another network or networks, also 
in  a  different  Member  State  (‘extension  of  area  of  use’).  When  TSIs  or  national  rules  provide  so,  type 
authorisation might also require a renewal to verify its compliance with revised requirements contained in 
these acts (‘renewed type authorisation’).  

19 

 
 
 
 
In general, regardless of the authorising entity, most applications for vehicle authorisation 
cover freight wagons (Figure 7). They account for 31% of all applications. Trainsets and 
locomotives  have  the  same  share  of  28%  each.  Special  vehicles  account  for  8%  of 
applications and the remaining 5% belong to passenger coaches.  

Figure 7. Structure of decisions for vehicle authorisation by vehicle type (June 2019 - June 
2024) 

Source: One-Stop Shop data. 

Freight  wagons  are  the  only  type  of  rolling  stock  where  multi-country  applications  for 
vehicle  authorisation  prevail  over  single-country  applications,  i.e.,  95.8%  of  all 
authorisation applications for freight wagons cover multiple Member States and must be 
addressed to the Agency. On the contrary, for locomotives the share of multiple Member 
States applications is 48.4% and further decreases for passenger vehicles (15.2%), trainsets 
(13.2%) and special vehicles (7.9%).  

This specific situation of freight wagons is linked to the fact that freight wagons are largely 
designed to be and often are operated in the whole EU, and the existing legal framework 
facilitates obtaining an EU-wide authorisation for this type of vehicles.  

The  Agency’s  workload  is  further  increased  by  single-country  applications  which  are 
addressed to ERA by applicants on a voluntary basis. ERA is particularly often chosen as 
authorisation  entity  in  case of locomotives  – 33.6% single-country applications for that 
type of vehicles are addressed to ERA. For trainsets this share is 22.4%, for special vehicles 
11.2% and for passenger coaches 10%. Overall, on average every fifth application (22.6%), 
which covered only one Member State, was sent to the Agency (Figure 8).  

20 

 
 
 
Figure 8. Evolution in the number of vehicle authorisation decisions covering single Member 
States delivered by ERA+NSAs and share of decisions issued by ERA (June 2019 - June 2024) 

Source: One-Stop Shop data. 

The crucial role played by the Agency in authorising freight wagons in the EU is illustrated 
in  Figure  9.  ERA  issued  97.4%  of  all  authorisation  decisions  relating  to  this  type  of 
vehicles  (both  for  single  and  multiple  Member  States).  The  Agency’s  role  is  also  very 
important in terms of authorising locomotives, where it is responsible for issuing 67.9% of 
all decisions. In both these cases the leading role of ERA as authorising entity is largely a 
result of the international character of these rolling stock manufacturing segments, as these 
types of vehicles are largely produced to be operated on a wider, EU market. This is less 
the  case  for  trainsets,  passenger  vehicles  and  special  vehicles  which  remain  a  national 
domain, with leading role of NSAs as authorising entities. ERA issues respectively only 
33.3%, 24.7% and 18.7% of the decisions for these groups of vehicles.  

Figure 9. Structure of decisions for vehicle authorisation by vehicle type, authorising entity, 
and area of use (June 2019 - June 2024) 

Source: One-Stop Shop data. 

21 

 
 
 
 
Processing of applications for vehicle authorisation, both by the Agency and by the NSAs, 
is subject to deadlines imposed by Article 34 of Implementing Regulation 2018/54530, i.e., 
one month for CTT authorisations, and five months for other types of authorisation cases 
(non-CTT). However, the period when the clock is on hold to allow the applicant to collect 
additional  necessary  documents  (time  freeze)  is  not  counted.  The  Agency  monitors  its 
performance against the legal deadlines and reports the results in its annual activity reports. 
From 2019 until 2023 the Agency reported 100% compliance with legal deadlines, taking 
into  account  the  time  freeze  agreed  with  the  applicants.  On  average,  processing  an 
application  for  vehicle  authorisation  took  5.3  months  over  the  period  June  2019  -  June 
2024. When the authorising entity is the Agency, a decision is issued on average after 5.7 
months, while in the case of NSAs, a decision is issued after 5 months.  

It  is  worth,  however,  noting  that  the  performance  of  both  ERA  and  NSAs  is  gradually 
improving  (Figure  10).  In  2020  and  2021  the  Agency  needed  respectively  6.3  and  6.5 
months to deliver a decision in non-CTT vehicle authorisation cases. The same types of 
applications were processed in 5.1 and 5.2 months by NSAs. In 2022 the gap between both 
types of authorities started to close and was almost closed in 2023, when ERA processed 
a  non-CTT  application  in  4.9  months  and  NSAs  in  4.8  months.  This  significant 
improvement in the application processing times was largely possible thanks to increasing 
level of knowledge about the process and associated requirements among applicants which 
led to an increasing quality of applications. 

Figure 10. Average duration for processing vehicle authorisations (in working days for CTT 
and in months for the others) by ERA and NSAs (June 2019 - June 2024) 

Source: One-Stop Shop data. 

The average time for delivering an authorisation depends on the vehicle type concerned 
(Figure 11). The best performance is recorded for passenger vehicles and freight wagons, 
where for all authorities, processing an application takes on average respectively 17% and 
10% less time than the average for all types of vehicles. The performance is also better 

30 OJ L 90, 6.4.2018, p. 66–104 

22 

 
 
 
than  the  average  in  case  of  trainsets.  On  the  other  hand,  authorisation  of  locomotives 
requires  almost  20%  more  time  than  the  average.  In  case  of  special  vehicles,  the  time 
required to receive an authority’s decision almost equals the average.  

Figure 11. Difference in average time to obtain a decision for non-CTT vehicle authorisations, 
per vehicle type (June 2019 - June 2024) 

Source: One-Stop Shop data 

For all vehicle types except freight wagons the average time to deliver an authorisation has 
improved when compared to the targets indicated in the 2013 Impact Assessment (22% 
reduction  from  24  months  baseline  of  authorisation  time  to  18.7  months).  For  freight 
wagons the target was not met since the baseline authorisation time prior to 4th Railway 
Package  was  set  to  2  months  which  is  much  shorter  than  the  legal  deadline  currently 
applicable. 

In  case  of  CTT  authorisations,  the  legal  deadline  for  issuing  a  decision  is  one  month; 
however, ERA imposed on itself a more ambitious target of five working days. Since April 
2020 the Agency’s performance fluctuated around that target to stabilise below it in August 
2022 (Figure 12). From that moment, it takes ERA between 2.5  and 4 working days to 
deliver a CTT decision.  In case of NSAs, on average  a period of  17.3  working days is 
required before a decision is issued; however, a positive trend of decreasing the necessary 
time can be observed since 2021. Data for first half of 2024 show that NSAs issued their 
decisions in less than 12 working days. 

23 

 
 
 
Figure  12.  Average  time  needed  by  ERA  to  reach  a  decision  on  applications  for  vehicle 
authorisation for CTT (June 2019 - June 2024) 

Source: ERA  

3.3.2 Safety certification  

Access to  the railway infrastructure is  granted only  to  railway undertakings that hold  a 
valid safety certificate confirming that the railway undertaking has established its SMS and 
is  able  to  comply  with  its  legal  obligations.  The  SSC,  introduced  by  the  4th  Railway 
Package, has replaced the previous scheme31.  

A SSC is valid for a given area of operation, i.e. a network or networks within one or more 
Member States where the railway undertaking intends to operate. If the area of operation 
covers more than one Member State, the application must be submitted to ERA. For single-
country applications, applicants can decide to apply either to ERA or to NSA.   

Between June 2019 and June 2024, the Agency received in total 453 applications for SSC. 
Contrary to vehicle authorisation, in case of safety certification most of applications are 
processed by the NSAs. In total, between June 2019 and June 2024 the NSAs delivered 
more than 2 times more applications than ERA, i.e., 1186 (Figure 13). 

Figure 13. Number of SSC applications received by ERA and NSAs (June 2019 - June 2024) 

450
400
350
300
250
200
150
100
50
0

41
20

2019

139

51

2020

280

306

111

2022

109

2023

263

97

2021

ERA

NSA

157

65

1H 2024

31 Prior to the entry into force of the 4th Railway Package, the safety certificate comprised a valid Part A 
safety  certificate  (certification  confirming  acceptance  of  the  railway’s  undertaking  safety  management 
system)  and  at  least  one  Part  B  safety  certificate  (certification  confirming  acceptance  of  the  provisions 
adopted by the railway undertaking to meet specific requirements necessary for the safe supply of its services 
on the relevant network). 

24 

 
 
 
 
Source: One-Stop Shop data 

The number of issued SSC decisions increased constantly since 2019, both for ERA and 
the NSAs. Every year the Agency is  responsible for between  26%  and 33% of all SSC 
decisions.  

There are three main types of applications for SSC. When a company did not yet have an 
SSC in the past, it needs to apply for one. Since SSCs are issued for a fixed period of time, 
not  exceeding  five  years,  when  a  certificate  is  about  to  expire,  the  concerned  railway 
undertaking  needs  to  apply  for  its  renewal.  Finally,  if  during  the  period  of  validity  of 
certificate, information included therein needs to be updated, an application for an update 
of  SSC  should  be  filed.  This  case  also  includes  situations  when  a  railway  undertaking 
extends its area of operation (either inside or outside a Member State).  

Most  of  the  applications  processed  since  2019  by  ERA  and  NSAs  concern  a  new  SSC 
(Figure 14). They account for 65.3% of all applications received. This high share is linked 
with the transition period from a model based on part A and B safety certificates towards 
a new model based on only one SSC. 

Figure 14. Number of SSC applications per type received by ERA and NSAs (June 2019  - 
June 2024) 

New single safety certificate

Renewal of safety certificate(s)

Update of safety certificate(s)

0

200

400

600

800

1000

1200

ERA

NSA

Source: One Stop Shop data  

SSCs are valid for types of operation indicated on the document: passenger traffic, freight 
traffic or shunting only, where the first two types can be combined. It is also possible to 
declare other type of operation, which needs to be further specified in the certificate.  

Figure 15. SSC issued by NSAs per type (June 2019 - June 2024) 

Shunting only
8%

Other
5%

Passenger and freight
10%

Passenger only
15%

Freight only
62%

Source: ERADIS data 

25 

 
 
 
Figure 16. SSC issued by ERA per type and area of operation (June 2019 - June 2024) 

domestic passenger and 
freight
11%
international passenger and 
freight
7%

domestic shunting only
1%

domestic passenger only
4%

international passenger only
10%

international freight only
41%

Source: ERADIS data 

domestic freight only
26%

It can be seen in Figures 15 and 16 that the structure of issued SSCs by type of operation 
does not differ significantly between ERA and the NSAs. Around two thirds of SSC issued 
by  both  authorities  cover  only  freight  operations.  Certificates  valid  for  only  passenger 
operations are the second most popular with an approximately five times lower share. In 
total, 58% of certificates issued by ERA cover international operations and 42% domestic. 
Therefore,  ERA’s  workload  is  driven  more  by  voluntary  applications  covering  single 
Member  States  than  in  case  of  VA,  where  the  average  share  of  single  Member  States 
applications is 19.3%. 

Most certificates covering operations only in one Member State were issued by ERA for 
railway  undertakings  from  Germany  (Figure  17).  This  was  linked  to  a  change  of  the 
German national legislation requiring also domestic railway undertakings to apply for an 
SSC from ERA.   

Figure 17. Origin of railway undertakings receiving SSC from ERA  per area of operation 
(June 2019 - June 2024) 

90

80

70

60

50

40

30

20

10

0

AT BE CH CZ DE DK EL

ES

FR HR HU IT

LT

LU LV NL PL PT RO SE

SI

SK

Source: ERADIS data 

multiple MS

single MS

26 

 
 
 
Overall,  the  share  of  multi-country  certificates  in  all  issued  documents  is  estimated  at 
14.6%.  

According  to  most  recent  data  from  the  Agency’s  annual  activity  reports32,  all  the 
applications received until end of 2023 were processed according to legal deadlines, i.e., 
150 days (five months), without counting the additional time the applicant needed to collect 
missing information.  

3.3.3 ERTMS Trackside Approvals  

The ERTMS trackside approval is issued by ERA and is required for the NSA to deliver 
an authorisation for the placing into service of trackside control-command and signalling 
subsystems.  The  approval  process  aims  at  confirming  that  the  envisaged  technical 
solutions are fully compliant with the relevant TSIs and are therefore fully interoperable. 

By June 2024, ERA has issued 19 decisions concerning ERTMS trackside approval and 
was processing further 125 applications, with 65% of the applications covering the roll-
out of European Train Control System (ETCS)33, further 26% applications pertaining to 
Global  System  for  Mobile  Communications-Railway  (GSM-R)  and  9%  concerning  the 
deployment of ERTMS (ETCS and GSM-R). Most applications come from Spain, Italy 
and Germany.  

The  ERTMS  trackside  approval  process  begins  before  the  call  for  tenders  relating  to 
ERTMS trackside equipment is issued. The Agency is obliged to issue a decision within 
two months from reception of all required information. However, since the application is 
shared with ERA at an early stage of the project, not all the necessary details will be known 
at the time of applying. The availability of necessary information depends largely on the 
tender preparation process, which is out of control of ERA. Experience from completed 
applications  show  that  it  can  take  up  to  43  months  to  collect  the  necessary  data  which 
allows  the  Agency  to  issue  its  decision.  On  average,  it  takes  19  months  before  all  the 
required information become available and the Agency can issue its decision. 

3.4 REMOVAL OF OBSOLETE NATIONAL RULES  

National rules34 refer to all binding rules adopted in a Member State, irrespective of the 
body issuing them, which contain railway safety or technical requirements, other than those 
laid down by Union or international rules, and which are applicable within that Member 
State to railway undertakings, infrastructure managers or third parties.  

National rules may be applied in addition to European rules only under certain conditions, 
as defined in the Interoperability and Safety Directives, e.g. when they relate to the placing 
on the market or placing in service of structural subsystems, the operation of the Union rail 
system,  the  role  of  the  actors,  the  safety  certification,  the  safety  authorisation  and  the 

32 ERA Work Programmes and Activity Reports | European Union Agency for Railways 
33 ETCS is installed on lineside, using balises only for location and radio for continuous communication with 
the on-board units. 
34National  rules  often  include  requirements  which  are  partly  relevant  for both  interoperability  and  safety 
purposes. This explains why the terms ‘national safety rules’ and ‘national technical rules’, as defined in 
former Directive 2004/49/EC and Directive 2008/57/EC respectively, are now replaced by the concept of 
‘national rules’.  

27 

 
 
accident  investigation.  National  rules,  which  are  often  based  on  national  technical 
standards, are being gradually replaced by rules based on common standards, established 
by CSMs and TSIs.  

The  volume  of  national  rules,  including  operating  rules,  is  expected  to  be  reduced  as  a 
consequence of extending the scope of the TSIs to the whole of the Union rail system and 
of  closing  open  points  in  the  TSIs.  For  that  purpose,  Member  States  should  keep  their 
system  of  national  rules  updated,  remove  obsolete  rules  and  inform  the  European 
Commission and the Agency thereof without delay. ERA examines the existing national 
rules in the Member States to ensure that only those national rules that are allowed under 
the relevant Union legislation remain applicable. The procedure for examination of draft 
national  rules  and  of  existing  national  rules  is  described  in  Article  25  and  Article  26, 
respectively, of ERA Regulation. Further, ERA is developing the Single Rules Database 
(SRD)35 that will be the unique tool for the notification of all draft national rules and all 
existing  national  rules.  The  process  is  very  burdensome  and  binds  significant  ERA 
resources; for example, 2 400 working hours were used in 2024 for the management of the 
national rules. 

In  2016,  ERA  developed  a  national  rules  cleaning-up  programme36,  which  presents  the 
methodology and the concrete actions to remove obsolete national rules as well as a series 
of deadlines for achieving significant milestones, including e.g., the analysis and validation 
of  national  technical  rules  for  vehicle  authorisation  by  end  of  2016,  the  analysis  and 
validation of national technical rules for fixed installations by end of 2018, and the removal 
types 4 and 5 national safety rules (made redundant by the entry into force of the revised 
OPE  TSI)  by  December  2018.  However,  the  Agency  has  only  partially  achieved  these 
goals  and  delays  emerged  in  all  areas.  In  2019  there  were  still  1026  national  rules 
applicable in addition to the TSIs in force, down from 13 459 in January 2016 (Figure 18). 
In June 2024, 796 national rules relevant for vehicle authorisation and fixed installations 
(formerly  referred  to  collectively  as  technical  national  rules)  remained  in  EU  Member 
States. The progress in removing these national rules since 2020 is shown in more detail 
in Figure 19. 

Figure 18. Progress in the removal of national rules relating to vehicle authorisation and fixed 
installations since 2016 (including the United Kingdom until the end of 2019) 

35 https://www.era.europa.eu/domains/registers/srd_en 
36 https://www.era.europa.eu/system/files/2022-11/era_rules_plan_overview_20160323_en.pdf  

28 

 
 
Source: ERA Report on Railway Safety and Interoperability in the EU 202437 

For all rules categories (vehicle authorisation, fixed installations and safety), the clean-up 
progress is still in its first round. This means that for some countries the Agency is still 
assessing  the  first  set  of  rules  notified  according  to  Article  14(1)(a)  of  Directive  (EU) 
2016/797.  

Figure 19. Evolution of national rules for vehicle authorisation and fixed installations since 
January 2020 (EU27) 

Source: ERA Report on Railway Safety and Interoperability in the EU 2024 

37 ERA Report on Railway Safety and Interoperability in the EU - 2024 

29 

 
 
 
 
3.5 COOPERATION WITH NATIONAL SAFETY AUTHORITIES  

With the implementation of the technical pillar of the 4th Railway Package, the Agency has 
taken over some responsibilities from the NSAs, however, their important role in operation 
of the railway system is maintained. The applicants have the choice between applying to 
the NSAs or to ERA for VA and SSC covering a single Member State. The NSAs also 
ensure oversight of the railway actors and safe performance of the national railway system. 
Furthermore, NSAs maintain a significant level of technical expertise necessary to perform 
their functions, which can be also used to support ERA in performing its own tasks.  

This dual system, with responsibilities shared between NSAs and the Agency, relies on 
effective cooperation between them. In the context of ERA’s authority tasks, there are two 
main areas of cooperation. The first area relates to the obligatory participation of NSAs’ 
experts in assessment of those parts of applications that are addressed to ERA, which are 
linked to national specificities or national rules of a Member State. To this end, Article 76 
of the ERA Regulation  requires the Agency  to  sign  a cooperation agreement  with  each 
NSA, which lays down the tasks and conditions for deliverables as well as the time limits 
applying  for  their  delivery,  and  how  the  fees  payable  by  applicants  should  be  shared 
between ERA and the NSAs, to compensate the latter for their work38.  

The  Agency  signed  cooperation  agreements  with  all  NSAs  before  the  target  date  of  31 
October 202039, which was the transposition date of the technical pillar of the 4th Railway 
Package applicable to the last group of Member States. 

The second area of cooperation between ERA and NSAs is voluntary and relates to the 
possibility  of  participation  of  NSAs’  experts  in  assessment  of  the  Agency’s  part  of 
applications, under Agency’s responsibility and upon its request. This arrangement is often 
referred to as ‘Pool of Experts’ and is based on voluntary cooperation agreements between 
ERA and the NSAs. The aim of establishing a Pool of Experts is to cover gaps in ERA’s 
resources  to  perform  authority  tasks,  more  specifically  the  shortage  in  some  specific 
language skills in the Agency since applicants are entitled to submit their application in 
any one of the official EU languages. The insufficient coverage of the necessary language 
skills is considered to be the main barrier for ERA to fully cover the issuance of vehicle 
authorisation and SSCs with its own resources.  

NSAs are financially compensated for the expert support provided to ERA according to 
the terms defined in cooperation agreements.  

As of September 2024, 18 Member States40 plus Norway and Northern Ireland have signed 
the voluntary cooperation agreements with ERA. The 6 remaining Member States seem 
not  interested in  similar  agreements  mostly due to the resource constraints they face to 

38 These agreements draw upon guidelines developed by ERA and NSAs that set out the main elements that 
could be used for the drafting of cooperation agreements between ERA and NSAs. Most NSAs have taken 
these  guidelines  as  basis  for  their  agreement  with  ERA,  without  major  changes.  Source:  NSA  Network 
Information Bulletin, October 2020, European Union Agency for Railways 
39 Source: Consolidated Agency Activity Report 2020 
40  Belgium,  Denmark,  Germany,  Estonia,  Ireland,  Greece,  Spain,  France,  Latvia,  Luxembourg,  Hungary, 
Netherlands, Poland, Portugal, Romania, Slovakia, Finland, Sweden 

30 

 
 
ensure  processing  of  their  own  applications41.  The  Agency  strives  to  increase  the 
involvement  of  the  pool  of  experts;  however,  this  remains  a  challenge42.  For  the  same 
reason, the Agency has difficulties in fully benefiting from the work of experts from NSAs 
which signed the voluntary cooperation agreements. Participation of an NSA expert in a 
specific project always requires a prior approval of the NSA which might not be granted if 
at the same time the NSA struggles to ensure adequate resources for processing of its own 
applications.  

Since  2019,  experts  from  8  NSAs  have  participated  in  processing  of  applications 
concerning VA. In case of SSCs, 13 NSAs provided their experts. Nevertheless, the share 
of work performed by NSAs’ experts is limited and amounts at only 5.3% of all the work 
hours performed on Agency’s applications since 2019 (Figure 20). The highest level of 
participation of NSAs’ experts was recorded in 2022 when it reached 8.3%. This was also 
the  first  year  when  the  Agency  issued  almost  2000  decisions  therefore  the  NSAs 
involvement  was  an  important  factor  which  helped  to  limit  the  pressure  on  Agency’s 
internal resources. However, in 2023 the share of workload provided by NSAs’ experts 
decreased to 5.6%. The share for 2024 is even lower, however data in this respect might 
not be entirely representative as the NSAs report their workload with a delay.  

Figure 20. Distribution of workload related to the assessment of ERA's part of applications 
(June 2019 - June 2024) 

Source: European Union Agency for Railways 

To  compensate  for  the  limited  capacity  of  NSAs,  the  Agency  uses  services  of  external 
experts  and  private  companies.  A  call  for  independent  experts  in  the  field  of  safety  is 
permanently open on the Agency’s website with the aim of supporting the tasks concerning 
issuing of SSCs. Currently, 32 experts are pre-qualified with different areas of expertise. 
Additionally, a cascade of private companies has been selected in a Framework Contract 
to  ensure  support  for  all  Agency’s  authority  tasks.  However,  since  2019,  both  external 
experts  and  private  companies  covered  only  2.4%  of  the  overall  workload  required  to 

41 Voluntary cooperation agreements (PoE). State-of-play, ERA presentation for the 61st meeting of the ERA 
Management Board, 16 November 2022 
42 Source: Consolidated Annual Activity Report of the European Union Agency for Railways, 2022 

31 

 
 
 
process applications received by the Agency. Main challenges related to the use of external 
experts and private companies concern the difficulty in ensuring necessary independence 
and lack of availability in critical moments in time. 

Although assessment of border stations is strictly not an area of cooperation between NSAs 
and ERA, it is also worth mentioning as it poses specific challenges for the operation of 
the dual system and impacts processing of applications both by the Agency and the NSAs. 
The  Safety  and  Interoperability  Directives  introduced  a  specific  simplified  solution  to 
include  border  stations  from  neighbouring  Member  States  in  the  area  of  operation  of 
railway undertakings and the area of use of authorised vehicles. This solution allowed in 
particular that application for SSC or VA could still be addressed to the NSA if it covered 
one Member State plus only border stations in neighbouring Member States. Requirements 
applicable  to  include  border  stations  in  certificate  or  authorisation  should  be  limited  to 
facilitate  cross-border  traffic  between  Member  States.  Details  of  the  applicable 
requirements and necessary assessment were to be established between NSAs in written 
agreements or on an ad-hoc basis.  

In practice, implementation of this mechanism proved to be difficult. Historically, NSAs 
had  little  or  no  role  in  identification  of  border  stations  and  definition  of  applicable 
requirements as this was managed by the infrastructure managers themselves or set out in 
international agreements at Member State level. For this reason, since the entry into force 
of the 4th Railway Package43, the NSAs have signed only 12 border agreements to date.  

As a result, applicants  are often faced with legal  uncertainties and differing approaches 
between NSAs. This remains a problem, with impact on cross-border traffic, in particular 
for vehicle authorisation where applicants seeking to access with their vehicles only short 
cross-border sections to border stations are required to meet the same requirements as when 
seeking authorisation covering the whole network of a neighbouring Member State.  

To address some of these issues, the network of NSAs has created a subgroup dedicated to 
discussion concerning border agreements.  

3.6 ONE-STOP-SHOP (OSS) 

OSS is an IT system supporting the applicants,  ERA and the NSAs in performing their 
tasks related to safety certification, vehicle authorisation and ERTMS trackside approval. 
It enables the exchange of documentation between all involved actors and allows ERA and 
the NSAs to share their comments and questions requiring a reply from the applicant. It 
aims to streamline and manage applications in a fair and transparent way that allows users 
to track progress and interact with both ERA and NSAs from the pre-engagement stage 
through to an authorisation or certification being issued. 

Due to the different deadlines for the transposition of the 4th Railway Package, initially 
only  8  Member  States  used  the  OSS  in  June  2019,  with  the  remaining  Member  States 
joining by October 2020. 

43   Informative lists of border stations in accordance with Article 10(8) of Directive (EU) 2016/798, 22 May 
2024,  European  Union  Agency  for  Railways,  available  at:  https://www.era.europa.eu/system/files/2022-
11/informative-list-border-stations_en.pdf?t=1734431347 

32 

 
 
According to ERA, more than EUR 7 million have been allocated to the development of 
the OSS and registers between 2015 and 2024, most of which was spent during the 2017-
2019 period. This includes effort and resources allocated in the period from 2020 to 2024 
to develop an interface between the OSS and the (ERADIS44 and ERATV45 supporting the 
safety  certification  and  vehicle  authorisation  process.  Further,  the  annual  maintenance 
costs for the OSS were estimated at around EUR 0.5 million in 2024 (Table 4) and the 
human resources required at around 1.5 FTE (equivalent to approximately additional EUR 
190 000). 

Table  4.  Financial  resources  allocated  to  the  development  and  maintenance  of  OSS  and 
interfaces with ERADIS and ERATV 

Year 

2015 

2016 

2017 

2018 

2019 

2020 

2021 

2022 

2023 

2024 
(est.) 

Amount 
(million 
EUR) 

0.05 

0.85 

1.55 

1.00 

1.20 

1.00 

0.50 

0.50 

0.20 

0.55 

Source: ERA estimates 

To  support  applicants  in  using  the  OSS  and  to  help  them  understand  ERA’s  new 
responsibilities and activities, the Agency developed guidelines, templates, and checklists, 
organised training activities for NSA staff46, and performed other dissemination activities. 
Furthermore,  ERA  maintains  an  OSS  Helpdesk  to  resolve  issues  flagged  by  NSAs  or 
applicants. 

ERA monitors the operation and performance of the OSS and has set a KPI target that for 
at  least  95%  of  significant  problems  detected  during  operation,  solutions  should  be 
available in a next release47. According to the annual activity reports this target was met 
each year from 2019 to 2023. 

3.7 MONITORING OF NATIONAL SAFETY AUTHORITIES 

Article  33  of  the  ERA  Regulation  granted  to  the  Agency  a  new  task  concerning  the 
monitoring of performance and decision-making of the NSAs on behalf of the European 
Commission. These audit activities are focused on the capacity of NSAs to perform their 
tasks as well as on the effectiveness of their monitoring of SMSs of railway undertakings 
and infrastructure managers.  

The  NSAs  play  a  pivotal  role  in  ensuring  safety  of  the  railway  system.  Through  its 
certification and supervision activities they monitor the performance of individual actors, 
enforce  the  existing  rules  and  drive  the  system  towards  continuous  improvement. 

44 The ERADIS database shall ensure that the information relevant to the safety and interoperability of the 
railways in the Member States is accessible and transparent to all interested parties and stakeholders in the 
railway, in accordance with the Directive (EU) 2016/798, the Directive (EU) 2016/797 and the Regulation 
(EU) 2016/796. https://www.era.europa.eu/domains/registers/eradis_en  
45 https://www.era.europa.eu/domains/registers/eratv_en 
46 For example, from March to April 2025, the Agency is offering training sessions on the One-Stop Shop 
(OSS) system for both Applicant Representatives and ERA/NSA officers, 
https://www.era.europa.eu/content/oss-training-2025.  
47 Release v1.9.1 of the OSS was released in February 2023. 

33 

 
 
 
 
 
 
 
 
 
 
 
 
Additionally, they support the actors in understanding and correctly applying the existing 
legislative framework. 

ERA’s Management Board was not able to reach a consensus on a method to be applied 
by the Agency during the audits. As a result, two methods were allowed: compliance model 
and monitoring matrix model48. The choice of the method to be applied in a given audit 
was left to the audited NSA49. The system of dual models creates some difficulties for all 
stakeholders;  however,  ERA  made  a  considerable  effort  to  ensure  that  both  produce 
comparable results.  

The  audits  are  structured  in  three-year  cycles  during  which  all  EU  NSAs  (and,  upon 
agreement, the NSAs of Norway and Switzerland) are to be audited. Potentially, the scope 
of ERA’s NSA monitoring activities could cover all the tasks allocated to NSAs in relation 
to railway safety and interoperability. However, for the first three-year audit cycle 2019-
2021, it was decided to focus on priority aspects considered essential to get assurance on 
the safety level achieved by Member States. The decision taken by the Management Board 
for a targeted scope of audits was justified by the Agency with reference to the significant 
resource  constraints for the financial  years 2019-2021. Therefore, the scope of  the  first 
audit cycle 2019-2021 was restricted to two specific areas: staff competence management 
within  NSA  and  supervision  activities.  The  Agency  identified  82  deficiencies  and  135 
observations50. On average, there were 3.15 deficiencies and 5.19 observations per audit. 
For 9 audited NSAs no deficiency was identified and only observations were recorded. 

Out of the two audited topics, supervision was raising the most concerns – it accounted for 
57 deficiencies. All NSAs with deficiencies had at least one related to this area. The main 
identified issues covered the lack of prioritisation of the supervision activities and risk-
based plan, the lack of evidence of decision-making criteria on how NSAs evaluate the 
correct application and the effectiveness of SMSs by rail companies, as well as the lack of 
fully effective enforcement powers.   

In the area of competence management 25 deficiencies were recorded, which covered 13 
NSAs. The issues identified concerned the lack of proper competence management system 
for  NSA  staff,  lack  of  independence  in  the  recruitment  process,  staff  turnover  and 
difficulties in recruiting and retaining staff with the necessary level of experience, and staff 
shortage. 

The second cycle 2022-2024 was extended to cover all tasks allocated to NSAs according 
to the EU acquis, including when an NSA is designated to perform a task by a Member 

48 The Compliance Model is based on the concept of compliance or non-compliance with a set of criteria and 
is  aimed  at  evaluating  the  extent  to  which  deviations  from  these  criteria  constitute  minor  or  major 
deficiencies. The Monitoring Matrix Model is based on the concept of PDCA (Plan- Do-Check-Act) cycle and 
focuses on evaluating the willingness and capability of the NSA to perform and monitor its tasks, identify 
gaps and implement changes when problems are identified. 
49 Out of 43 finalised audits, only in 7 cases the NSAs decided to apply the matrix model. 
50 An observation is a finding that does not prevent the NSA concerned from effectively carrying out its duties 
in relation to railway safety and/or interoperability, while a deficiency is a finding or combination of findings 
that prevents the NSA concerned from effectively carrying out its tasks in relation to railway safety and/or 
interoperability. For deficiencies, the Agency requests NSAs to take appropriate remedy actions and NSAs 
are  requested  to  produce  action  plans  to  address  them  (source:  “Annex  II:  Evaluation  Procedure”  of 
Management Board Decision 161 of 29/11/2017). 

34 

 
 
State provided that this task is linked with the application of EU law. As of February 2025, 
results  were  available  for  20  NSAs.  The  extended  scope  of  audits  resulted  in  a  higher 
number of findings: 238 deficiencies and 291 observations. This gives an average of 11.9 
deficiencies and 14.6 observations per audit51. 

As in the case of the first audit cycle, supervision remains the biggest concern followed by 
safety certification and authorisation processes, organisation of the NSA (which covers the 
topic  of  competence  from  the  first  audit  cycle)  and  authorisation  of  fixed  installations 
(Figure 21).  

Figure 21. Share of deficiencies identified by the Agency in the second NSA monitoring cycle, 
per topic 

Source: ERA audit reports 

NSAs  are  required  to  produce  an  action  plan  to  address  all  identified  deficiencies.  The 
assessment performed by the Agency during the second audit cycle showed that the NSAs 
made limited progress to address the identified deficiencies from the first cycle. Only 18% 
of  deficiencies  were  fully  addressed;  a  further  51%  were  addressed  only  partially.  The 
remaining 31% deficiencies were not addressed at all. In a limited number of cases only, 
lack of reaction is linked to the fact that the identified issue is beyond the control of NSA 
(it requires an intervention at Member State level, e.g. change of legislation or allocation 
of additional resources).  

Deficiencies from the first cycle that were confirmed as open were incorporated into the 
findings from the second audit cycle and will be followed up during the third audit cycle. 

In  case  of  four  NSAs  audited  in  the  second  cycle,  the  Agency  identified  more  than  20 
deficiencies  (Table  5).    For  a  further  two,  more  than  15  deficiencies  were  registered. 
Among these six NSAs deficiencies were identified for at least 2/3 of all audited processes, 

51 A degree of caution should be applied when drawing conclusions from these numbers. In the second audit 
cycle, the Agency prioritised NSAs which had poor results in the first cycle. As a result, NSAs with better 
performance were planned to be audited closer to the end of the cycle. Therefore, current interim results are 
likely biased towards poorer performance.   

35 

 
 
 
with one NSA having deficiencies in all audited processes. Out of all audited NSAs, 12 of 
them had deficiencies in at least half of the audited areas. 

Table 5. Summary of findings in the second cycle of NSAs audits 

Number of deficiencies 

Number of 
observations 

Share of processes with 
deficiencies 

NSA 1 
NSA 2 
NSA 3 
NSA 4 
NSA 5 
NSA 6 
NSA 7 
NSA 8 
NSA 9 
NSA 10 
NSA 11 
NSA 12 
NSA 13 
NSA 14 
NSA 15 
NSA 16 
NSA 17 
NSA 18 
NSA 19 
NSA 20 

27 
25 
24 
24 
17 
17 
13 
13 
13 
12 
11 
10 
7 
6 
5 
4 
4 
3 
2 
1 

14 
20 
19 
11 
17 
10 
21 
16 
15 
11 
11 
15 
14 
13 
13 
30 
8 
11 
13 
9 

88.9% 
70.0% 
90.0% 
100.0% 
66.7% 
81.8% 
80.0% 
63.6% 
60.0% 
71.4% 
44.4% 
75.0% 
30.0% 
50.0% 
30.0% 
30.0% 
25.0% 
20.0% 
11.1% 
9.1% 

Source: ERA audit reports 

3.8 MONITORING OF NOTIFIED BODIES 

NoBos  provide  independent  third-party  conformity  assessment  to  demonstrate  whether 
specific  requirements  related  to  a  product  have  been  met,  both  in  terms  of  design  and 
manufacturing. They typically intervene in the process before ERA and the NSAs conduct 
their assessments of the applications received and their positive assessment is a prerequisite 
for obtaining an authorization for the placing on the market of vehicles and authorization 
for placing into service of fixed installations. NoBos must meet the requirements laid down 
in Article 30 of Interoperability Directive52; this is verified either by a designated authority 
of  a  Member  State  (recognised  NoBo),  or  by  a  national  accreditation  body  (accredited 
NoBo). 

Both types of NoBos are subject to the monitoring activities of the Agency. Pursuant to 
Article 33(6) of ERA Regulation, the Agency is empowered to perform inspections of all 
NoBos in order to verify specific areas of their activities and operation, and in particular 
to review documents, certificates and records relating to performed conformity assessment 

52 Such as being established under national law and having legal personality, being capable of carrying out 
all the conformity assessment tasks assigned to it by the relevant TSI and in relation to which it has been 
notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and 
under its responsibility. 

36 

 
  
 
procedures. Additionally, in case of recognised NoBos, pursuant to Article 33(3) of ERA 
Regulation, the Agency can audit them to verify their capacity to meet the requirements of 
the Interoperability Directive. Therefore, the requirements checked by audits cover a wider 
scope of requirements than inspections. 

The procedure for auditing NoBos has been established by ERA Management Board in 
201753. ERA and the national notifying authority (or its delegate) jointly define the scope 
of any audit and carry out the audit as a joint activity. Unlike the case of NSA monitoring, 
ERA’s Management Board did not indicate any multi-annual target to be achieved about 
the number of NoBos to be monitored each year.  

Inspections are performed according to a Work Instruction being part of the internal quality 
management system of the Agency. The process of preparing and performing an inspection 
largely mirrors the procedure for audits. 

There are 68 NoBos for the purposes of the Interoperability Directive, out of which 14 are 
recognised and 54 accredited. Until November 2024, a total of 49 NoBos were audited or 
inspected  (Figure  22)  that  represents  72%  of  all  NoBos  under  the  Interoperability 
Directive. The number of audits and inspections increased from 2022 onwards. 

Figure 22. Number of NoBos monitored by ERA per year, 2019 - 2024 

Source: ERA presentation at the NSA Network meeting of 13 November 2024 

ERA has completed the first three-year full monitoring cycle for NoBos (2019-2021) over 
the course of which it issued in total  14 audit/inspection reports. Therefore, in this first 
cycle, ERA audited only 23% of the total number of NoBos under its mandate. For the 
cycle 2022-2024 ERA issued 10 audit/inspection reports in 2022 and another 11 in 2023. 
Therefore,  auditing  all  68  NoBos  in  the  period  2022-2024  will  likely  not  be  achieved, 
which reflected the difficulties in securing adequate resources for this task.  

The allocation of additional resources under the Strengthening Action Plan increased the 
FTEs assigned to  NoBo  monitoring. On top  of regular 4  FTEs  assigned to this  task, in 
2023, the work of 1 additional FTE was added. In 2024 the overall resource envelope was 
further  increased  to  6.1  FTEs,  with  2.1  FTEs  assigned  from  the  Strengthening  Action 

53  Decision  n°156  of  the  Management  Board  of  the  European  Union  Agency  for  Railways  adopting  the 
provisions  on  auditing  notified  conformity  assessment  bodies  in  the  framework  of  Article  34  §  3  of 
Regulation (EU) 2016/796, 27 June 2017 

37 

 
 
 
Plan54. This allowed to gradually increase the number of audits and inspections performed 
per year, up to 15 in 2024. The Agency plans to monitor 18 NoBos in 2025, which would 
allow to close the first cycle of monitoring of NoBos after 7 years.  

The Agency has identified 190 deficiencies55, out  of which 21 were classified as major 
deficiencies which impacted NoBos from 9 Member States (Figure 23). To follow them 
up, the Agency acting in accordance with Article 34(4) of ERA Regulation, has issued a 
recommendation  asking  the  Member  State  where  the  NoBo  is  established  to  take  the 
appropriate measures to address the major deficiencies within a mutually agreed deadline. 
Two  thirds  of  all  major  deficiencies  (14  cases)  have  been  positively  closed  within  6 
months; the remaining  7 deficiencies are open and will be followed up  during the next 
monitoring cycle.  

Figure 23. Distribution of major deficiencies per criteria, 2019 - 2024 

Source: ERA presentation on NSA Network of 13 November 2024 

Over  70%  of  major  deficiencies  identified  by  the  Agency  were  linked  to  two  areas: 
certification body personnel and management of impartiality. The most recurring major 
deficiencies concerned ability of certification body to ensure continuity of the necessary 
competence  (4  cases)  and  impartiality  towards  actors  linked  with  assessed  products, 
processes or services and providing consultancy to them (3 cases).  

For other findings (minor deficiencies and observations) NoBos usually present an action 
plan  that  is  further  verified  by  the  corresponding  national  authority  or  national 
accreditation body in their surveillance activity. The Agency is kept informed about the 
developments. 

54 Single Programming Documents of the Agency for 2023 and 2024. 
55 The Agency classifies findings of its monitoring activities of notified bodies as major deficiencies, minor 
deficiencies, and observations. Major deficiencies are defined as those that prevent the notified body from 
effectively carrying out its tasks in relation to railway interoperability. Minor deficiencies do not impact the 
ability of notified body to perform its tasks in relation to railway interoperability. 

38 

 
 
 
4.  EVALUATION FINDINGS (ANALYTICAL PART) 

4.1 TO WHAT EXTENT WAS THE INTERVENTION SUCCESSFUL AND WHY?  

Effectiveness 

Agency’s achievement of objectives 

In  relation  to  its  first  objective,  i.e.  to  maintain  a  high  level  of  railway  safety  and 
improve interoperability in the EU, the Agency has delivered relevant outputs - fully or 
partly - in several areas that contribute to maintaining and further enhancing safety in the 
railway sector and identifying and addressing existing limitations. Its work on screening 
national  safety  rules,  developing  and  updating  CSMs,  and  issuing  SSCs  contributes 
towards ensuring a more harmonised approach on safety aspects across the EU. Achieving 
tangible  impacts  to  improve  safety  is  a  process  that  takes  time  and  depends  on  several 
factors, including the capacity, resources available and action taken at national level, by 
NSAs, infrastructure managers and national authorities.  

The safety level of the EU railway system remains very high; it is in fact one of the safest 
railway systems in the world. The number of significant accidents and resulting casualties 
have decreased steadily since 2010; however, in 2021 and 2022, an increase was recorded, 
going back to pre-COVID-19 levels56 (Figure 24).  

Figure 24. Significant accidents, fatalities and serious injuries (2010 – 2022)  

Source: ERA Report on Railway Safety and Interoperability in the EU – 2024 

In a multimodal comparison, rail appears the safest mode of land transport in the EU, with 
a fatality rate for passengers similar to that for aircraft passengers (Figure 25).  

56 Report on Railway Safety and Interoperability in the EU - 2024 

39 

 
 
 
Figure 25. Onboard fatalities per billion passenger-km 

Source: ERA Report on Railway Safety and Interoperability in the EU – 2024 

The  results  of  the  latest  assessment  of  the  achievement  of  safety  targets57  (carried  out 
annually by ERA) indicate that safety  performance remains acceptable  at  the EU level, 
although  possible  deterioration  in  safety  performance  was  identified  in  four  instances. 
Such a result is in line with the previous assessments, which typically identified possible 
deterioration in safety performance in a few countries and categories. 

Major rail accidents resulting in five or more fatalities have become rare: no such accidents 
occurred  in  2018,  2020  and  2021,  but  five  such  accidents  occurred  in  2022  and  2023 
(including  the  tragic  accident  in  Tempi,  Greece,  in  February  2023,  which  caused  57 
fatalities). The number of fatal train collisions and derailments has decreased continuously 
since 1990. In recent years (2020–2022), however, a slight increase was registered, with 
18 such accidents. The rates of significant accidents, fatalities, and fatalities and weighted 
serious  injuries  (FWSIs)  per  million  train-km  have  decreased  substantially  since  2010, 
with the lowest values registered in 2020 and 2021; however, in 2022, the rates returned 
to pre-COVID-19 levels. Progress has also been uneven across the EU Member States with 
significant variation in safety levels. Despite the drop in 2021, the passenger fatality rate 
shows a worrying stagnating (even slightly rising) trend since 2017. 

An important role in maintaining a high level of safety should be played by the occurrence 
reporting that is aimed at helping railway operators assess the risks of their activities and 
prevent accidents. While it is easy to make a link between accidents and their causes after 
they  occur,  it  is  essential  to  identify  and  share  the  relevant  information  beforehand,  to 
prevent accidents from happening.  

Article 18 of ERA Regulation provides for the obligation of the Agency to encourage the 
exchange  of  safety  related  occurrence  information  for  the  purpose  of  developing  best 

57 Report Assessment of achievement of safety targets – 2025 | European Union Agency for Railways 

40 

 
 
 
practices.  However,  it  does  not  provide  the  means  to  enable  proper  data  collection  and 
enforcement of obligations on the different actors.  

The  inability  to  identify  and  share  relevant  information  in  advance  can  lead  to  serious 
safety issues. On 2 January 2019 a passenger train operating over the Great Belt Bridge in 
Denmark collided with debris that had come off a freight train, killing 8 passengers and 
injuring 16. The likely cause of the accident was that one of the lorry trailers carried by the 
freight train was damaged by high winds while crossing the bridge. Accidents caused by 
high wind velocity have happened in several Member States, and in the UK (one accident 
in  2015,  two  in  2008),  Norway  (in  2017)  and  Switzerland  (in  2018).  However,  this 
information  was  not  shared  systematically  between  Member  States.  A  Joint  Network 
Secretariat (JNS) procedure58 “Great Belt bridge accident/incident” was initiated in June 
2019. 

Since  May  2017,  10  JNS  procedures  were  launched.    This  demonstrates  the  increasing 
importance of this workstream within the Agency. 

The CSMs for occurrence reporting are not matched by an appropriate enabling tool and 
resources.  Nowadays,  the  Agency  is  suffering  of  the  historical  accumulation  of  safety-
related IT tools based on different technologies, lacking a consistent approach.  

Shortly  after  the  Great  Belt  Bridge  rail  accident  in  Denmark,  on  7  January  2019  the 
Commission  mandated  the  Agency  to  draft  common  safety  methods  for  assessing  the 
safety level and the safety performance of railway operators at national and Union level 
(CSM  ASLP).  Consequently,  the  Agency  addressed  a  Recommendation  for  this  CSM 
ASLP59, largely endorsed by all railway stakeholders, to the Commission on 18 May 2021. 
The Commission Delegated Regulation on CSM ASLP60 has not yet been adopted. Once 
adopted, the CSMs introduced in this Regulation should establish a harmonised assessment 
of  safety  levels,  a  harmonised  assessment  of  safety  performance  and  a  well-structured 
process to help each railway operator, NSAs and ERA to qualitatively and quantitatively 
learn about the causes of accident and incident occurrences and about their consequences 
in  terms  of  victims  and  damages.  The  successful  and  smooth  implementation  of  CSM 
ASLP strongly depends on the availability of an ‘Information Sharing System’ (ISS), for 
which adequate resources are needed, supporting in general the ‘safety digitalisation’ of 
the railway sector. Such an approach has already been successfully implemented in  the 
aviation sector. 

On  the  monitoring  of  NSAs,  the  Agency  activities  have  been  partly  delivered  and 
contributed  to  improving  the  functioning  of  NSAs  and  NoBos  and  harmonising  their 
performance.  A  large  share  of  NSAs  and  national  authorities  responding  to  a  survey 

58 The JNS procedures aim at EU-wide harmonisations of any action taken after accidents or incidents on 
EU railways: Joint Network Secretariat (JNS) | European Union Agency for Railways 
59https://www.era.europa.eu/system/files/2022-

10/CSM%20Regulation%20recommended%20for%20adoption.pdf?t=1759151061  

60  Adoption foreseen for 2026. 

41 

 
 
organised in the context of the evaluation support study provided a positive opinion on the 
contribution of ERA’s NSA monitoring towards: 

• 

• 

improving performance and decision-making of NSAs (7 out of 12 NSAs and 7 out of 
10 national authorities), and  

its contribution to ensuring that NSAs effectively monitor the SMSs of the rail actors 
(seven out of 11 NSAs and 6 out of 10 national authorities). 

The first audit cycle was completed – albeit with reduced scope – and there is generally 
positive input on the effectiveness of ERA’s monitoring activities. Most NSAs and national 
authorities contributing to the survey indicated that their experience with NSA monitoring 
has been positive in terms of the quality of the audit process. On average, concerning all 
the parameters on which an assessment was requested, 10 out of 12 of NSAs and 8 out of 
10  national  authorities  that  responded  provided  positive  feedback  on  the  monitoring, 
compared, respectively, to two NSAs and one national authority which provided negative 
feedback.  

As presented in detail in Section 3.7, the second cycle 2022-2024 was extended to cover 
all  tasks  allocated  to  NSAs  according  to  the  EU  acquis,  including  when  an  NSA  is 
designated to perform a task by a Member State provided that this task is linked with the 
application  of  EU  law.  The  extended  scope  of  audits  resulted  in  a  higher  number  of 
findings: 238 deficiencies and 291 observations. The assessment performed by the Agency 
during the second audit cycle showed that the NSAs made limited progress to address the 
identified deficiencies. In some cases, this is linked to the fact that the identified issue is 
beyond the control of NSA (it requires an intervention at Member State level, e.g. change 
of  legislation  or  allocation  of  additional  resources).  One  of  the  main  difficulties  which 
impact  the  effectiveness  of  addressing  the  deficiencies  by  NSAs  is  lack  of  appropriate 
knowledge, experience and competences among the NSAs staff.  

The findings from the Agency’s audits show that there are Member States where the NSAs 
are unable to effectively perform their role61, and hence the urgent need for improvement 
in this respect, given that this poor performance results in weak oversight of the railway 
system  in  specific  Member  States.  This  creates  a  potential  gap  which  could  result  in 
significant non-conformities being left unnoticed for years.  

There is  a need to  ensure a full cycle for the monitoring activities, in  which findings  – 
supplemented and feeding information from other tasks (e.g. SSCs, VAs, safety data, etc.) 
- are consistently reviewed and acted upon, regularly tracking the progresses.              

The NSA monitoring process is not adequate to identify such wider potential issues due to 
its limited scope which does not cover the performance of other stakeholders having an 
important  safety  role  like  railway  undertakings,  infrastructure  managers,  National 
Investigation Bodies (NIBs) or Member States authorities.  

61 In case of four NSAs audited in the second cycle the Agency identified more than 20 deficiencies.  For 
further two more than 15 deficiencies were registered. Among these six NSAs deficiencies were identified 
for at least 2/3 of all audited processes, with one NSA having deficiencies in all audited processes. Out of all 
audited NSAs, 12 of them had deficiencies in at least half of the audited areas (see 3.5 Monitoring of National 
Safety Authorities). 

42 

 
 
Although  the  Agency  is  empowered  under  Article  35  of  ERA  Regulation  to  perform 
complex  assessments  of  practical  implementation  of  rail  safety  and  interoperability 
legislation which could cover all relevant actors, this process was designed as an ad hoc 
task performed on a specific request of the Commission and not as a regular monitoring 
process. As a result, the current budgetary envelope of the Agency does not include the 
necessary  resources  to  perform  such  complex  assessments  at  Member  State  level  on  a 
regular basis.  

This weakness of the existing Union framework was also noticed during the investigation 
of the tragic accident in Tempi, Greece, which costed the lives of 57 people. In its final 
investigation report, the Hellenic Air and Rail Safety Investigation Authority included a 
recommendation (2025-RL01-013) which calls on the European Commission to ‘develop 
and implement  a framework where, based on  continuous monitoring of the respect  and 
effectiveness  of  Members  State  responsibilities  under  the  Safety  Directive,  necessary 
corrective  actions  can  be  agreed,  and  their  timely  implementation  followed  up  and 
enforced’62.  

Linked to the above considerations and to the difference in safety levels across EU Member 
States,  the  Agency  proposed  in  2023  a  Priority  Country  Programme  (PCP)  which  is  a 
strategic  initiative  that  aims  to  assess  and  monitor  the  state  of  railway  safety  and 
interoperability legislation implementation in Member States providing a comprehensive 
picture of railway safety and helping the Member States to identify areas for improvement. 
As of now, the PCP is still awaiting the necessary resources for implementation. Should 
the required resources become available, the PCP will support selected countries through: 
(1) a comprehensive assessment of the implementation of rail safety and interoperability 
legislation,  (2)  tailored  Action  Plans  at  Member  State  levels  and  (3)  dissemination 
activities tailored to the needs of each country.   

With regard to the NoBo monitoring, the number of responses to the survey questions 
was low (4 contributors). The NSAs and national authorities were generally positive about 
the  effectiveness  of  ERA's  monitoring  activities:  all  4  respondents  agreed  that  ERA’s 
monitoring  has  significantly  contributed  to  a  better  harmonisation  of  accreditation/ 
recognition  of  NoBos.  2  out  of  4  respondents  agreed  that  the  Agency’s  monitoring 
contributed  significantly  to  ensuring  a  standard  level  of  performance,  organisation,  and 
decision-making of NoBos. 

Nonetheless, the stakeholders answering the survey expected that the results of the NoBos 
monitoring would be more evident in the years to come because ERA was still gaining 
experience  in  this  area.  To  be  noted  that  by  the  time  the  consultation  activities  were 
conducted  (April-July  2022),  only  a  small  number  of  NoBos  were  monitored  and  little 
information was available on the results.  

As presented in  more detail  in  Section 3.8, ERA has completed the first  three-year full 
monitoring cycle for NoBos (2019-2021). Over this period, it audited only 23% of the total 
number of NoBos under its mandate and issued in total 14 audit/inspection reports. For the 
cycle 2022-2024 ERA issued 10 audit/inspection reports in 2022 and another 11 in 2023. 

62 Recommendation 2025-RL01-013 from the rail accident report Head-on collision between a passenger 
at 
train 
https://www.harsia.gr/index.php/2025/02/25/prosechos-to-porisma-gia-ta-tempi-stis-27-2-2025/  

28  February 

in  Tempi, 

document 

available 

freight 

2023, 

train 

and 

a 

43 

 
 
Therefore, auditing all 68 NoBos in the period 2022-2024 was not achieved, which reflects 
the difficulties in securing adequate resources for this task.  

The Agency has identified 190 deficiencies63, out  of which 21 were classified as major 
deficiencies  which  impacted  NoBos  from  9  Member  States.  Two  thirds  of  all  major 
deficiencies  (14  cases)  have  been  positively  closed  within  6  months;  the  remaining  7 
deficiencies are open and will be followed up during the next monitoring cycle.  

Over  70%  of  major  deficiencies  identified  by  the  Agency  were  linked  to  two  areas: 
certification body personnel and management of impartiality. The most recurring major 
deficiencies  concerned  the  ability  of  a  certification  body  to  ensure  continuity  of  the 
necessary  competence  (4  cases)  and  impartiality  towards  actors  linked  with  assessed 
products,  processes  or  services  and  providing  consultancy  to  them  (3  cases).  These 
findings, along with insights from the ERA VA process, indicate a need to strengthen the 
reliability and performance of certain NoBos. 

In terms of technical support in the field of railway safety and interoperability, ERA 
has  delivered  most  of  the  requested  opinions  and  technical  advice  within  the  legal 
deadlines or with slight delays, and with output that was assessed by most stakeholders to 
be of high quality.  

Six out of 14 NSAs and all industry rail representatives (10 out of 10) participating in the 
survey provided positive input on the quality of opinions issued concerning safety-related 
and  interoperability-related  aspects.  Some  issues  were  nevertheless  mentioned  by  the 
stakeholders such as the non-compliance with the deadlines for publication of opinions - 5 
out of a total of 29 opinions were published with over 6 months delay - and the use of light 
impact assessments accompanying opinions in cases that are considered inappropriate by 
some stakeholders.  

There was mixed input from NSAs or railway sector representatives participating in the 
survey  on  the  quality  of  the  impact  assessments.  Only  a  subset  of  NSAs  (6  out  of  14) 
provided a positive assessment and 6 out of 8 rail industry representatives commented that 
the quality of these outputs was “poor”. Some railway sector stakeholders considered that 
important  decisions,  with  a  potentially  significant  financial  impact  for  the  sector,  were 
made on the basis of impact assessments which, in their view, were excessively light and 
superficial  in  content.  However,  these  issues  did  not  have  a  significant  impact  on  the 
effectiveness of ERA’s technical support in the field of railway safety and interoperability. 

The available evidence does not allow to quantify the level of contribution towards the 
achievement of the objective of maintaining a high level of safety and interoperability 
of  the  EU  railway  system.  The  Agency’s  contribution  in  this  area  was  a  result  of  the 
combination  of  its  work  in  the  development  of  common  requirements  for  safety 
management, its activities in monitoring and promoting the implementation of a common 
EU approach to safety management across the EU, as well as through its new role as the 
authority  issuing  SSCs.  ERA  has  delivered  relevant  outputs  in  a  number  of  areas 

63 The Agency classifies findings of its monitoring activities of notified bodies as major deficiencies, minor 
deficiencies, and observations. Major deficiencies are defined as those that prevent the notified body from 
effectively carrying out its tasks in relation to railway interoperability. Minor deficiencies do not impact the 
ability of notified body to perform its tasks in relation to railway interoperability. 

44 

 
 
contributing towards maintaining and further enhancing safety in the railway sector and 
identifying  and  addressing  existing  limitations  such  as  the  annual  assessment  of  the 
performance  of  Member  States  on  the  basis  of  Common  safety  indicators,  a 
recommendation  for  the  CSM  ASLP  in  2021,  and  the  assessment  of  the  SMS  of  the 
applicants as part of the safety certification process and the issuing of SSCs. 

Concerning  its  second  objective,  i.e.  to  contribute  to  eliminating  operating  barriers 
and overcoming the fragmented set of national frameworks and rules, the Agency’s 
main roles are in the structured and systematic process of screening and removing obsolete 
national rules and its assistance in the development of TSIs.  

ERA assisted in the development and update of 16 TSIs since 2017 - including the most 
recent  2023  TSI  revision  package  -  integrating  technological  development  in  terms  of 
digitalisation  and  automation.  In  general,  the  process  of  contributing  to  developing  the 
TSIs - through the support of the working parties - has received positive comments from 
the stakeholders, including the approach of developing and updating TSIs in packages that 
can also increase consistency, even though there are still some concerns in terms of ERA’s 
capacity to  effectively  integrate  change  requests  as well as innovation  in  the TSIs. The 
consensus-based approach adopted by the Agency in the development of the TSIs may not 
always  allow  to  integrate  technological  development  in  the  TSIs  adopted.    Further,  the 
additional time and costs that are needed for obtaining authorisations and certification of 
innovative solutions could also be an inhibiting factor.  

Further,  the  Agency  has  made  progress  in  the  screening  and  removal  of  national 
technical rules to ensure an approach that is harmonised across the EU and consistent with 
the TSIs. However, there have been significant delays in the process in relation to the initial 
deadline of November 2018. In June 2024, 796 national rules relevant for VA and fixed 
installations  remained  in  EU  Member  States,  down  from  13  459  in  January  2016. 
According to ERA, to achieve a complete removal of all existing national rules, the number 
of FTEs allocated to this task would need to increase from around 5 FTE in the period 
2020-2022  to  over  8  FTEs.  Screening  and  removing  these  additional  rules  will  require 
considerable effort by personnel with detailed technical and operational knowledge, while 
there is in parallel significant demand for work on TSIs, CSMs, safety  certification and 
VA.  

Stakeholders provided a mixed view on the activities of the Agency related to the review 
of existing and new national rules: 

•  NSAs had a mixed opinion on the effectiveness of ERA’s assessment of national rules 
and the identification of redundant  ones, while  opinions  were mostly  positive when 
commenting on the actual reduction of the total number of national rules.  

•  The  opinion  of  railway  sector  representatives  was  instead  mostly  positive  on  the 
effectiveness of ERA’s evaluation of national rules and the identification of redundant 
ones,  while  a  mixed  view  was  provided  on  the  reduction  of  the  national  rules. 
Furthermore, they agreed that reducing national rules has resulted in cost savings and 
expressed a desire for speeding up the clean-up of the remaining rules. 

•  National  authorities  were  either  neutral  or  provided  a  mixed  view  on  the  three 

parameters. 

45 

 
The  main  strengths  of  the  process  of  screening  and  reduction  of  national  rules  are 
considered to be: 

• 

• 

• 

the  good  level  of  development  and  thoroughness  of  the  screening  process  and  the 
consequent transparency of existing national rules and identification of the potential 
for further harmonization in TSIs.  

the technical knowledge of the Agency's staff and their willingness to interact with 
national authorities and provide guidance. 

the  availability  of  guidelines  to  ensure  a  homogeneous  approach  to  national  rules 
across the EU. 

The main benefits of the process were considered to be the actual reduction in the number 
of national rules, the stimulus given by the ERA to Member States in terms of questioning 
the relevance of their national rules, as well as the guidance provided by ERA, which helps 
to form a common understanding of the remaining areas where national standards remain 
relevant and how harmonized EU legislation should relate to these remaining standards. 

In terms of the main limitations of the process, according to stakeholders these include:  

• 

• 

• 

• 

the perceived slowness of the evaluation of national rules and the frequent delays with 
respect to regulatory deadlines, 

the limited knowledge of national legal systems by ERA staff, 

the uncertainty about the definition of what constitutes a national rule, 

lack of clarity on the general objectives of the process, 

•  difficulties in using national rules registers (e.g. the Single Rules Database). 

Concerning any adverse effects or unintended consequences of the process, stakeholders 
mentioned the potential for legal uncertainty and the creation of gaps in legislation (i.e. 
areas no longer covered by national rules but not adequately covered by EU legislation 
either); administrative burden for national authorities; and a potential burden on railway 
undertakings,  as  rail  companies  compensate  for  the  elimination  of  national  rules  with 
additional internal procedures. These concerns appear valid and, while they are context 
specific, if unaddressed, they could limit the processes’ ability to achieve its objectives.  

On the establishment and operation of key registers, the ERA Regulation requires the 
Agency  to  set  up  and  maintain  the  EVR  and  the  ERATV.  Further,  ERA  shall  act  as  a 
system authority for a series of registers64 referred to in other pieces of legislation such as 
the Interoperability and  Safety  Directives;  this  includes among  others  the ERADIS, the 
European  Railway  Station  Accessibility  Database  (ERSAD),  the  SRD,  the  Reference 

64 The tasks of the Agency include in particular: 
(a) developing and maintaining specifications of the registers.  
(b) coordinating developments in the Member States in relation to the registers.  
(c) providing guidance on the registers to relevant stakeholders.  
(d) addressing recommendations to the Commission regarding improvements to the specifications of existing 
registers, where necessary including simplification and deletion of redundant information, and any need to 
set up new ones, subject to a cost-benefit analysis. 

46 

 
 
Document Database (RDD), the European Centralised Virtual Vehicle Register (ECVVR) 
and the RINF.  

Overall, the development of registers has been mostly in line with the expected outcomes 
of the 4th Railway Package. However, due to the small number of responses received from 
the consulted stakeholders (i.e., rail sector representatives and NSA), it is not possible to 
draw strong conclusions.  

Rail sector representatives had, in general, a neutral view (neither agree nor disagree) on 
the easiness of use of the registers. However, for some specific registers they disagreed. 
This is the case of ERATV (4 out of 6), RDD (4 out of 6), and RINF (3 out of 6). The view 
of  NSAs  slightly  differs  from  that  of  the  rail  industry.  A  larger  proportion  of  NSAs 
disagreed with ERADIS being an easy tool to use (4 out of 13). It is also worth noting the 
relatively higher proportion of NSA who disagree with this statement for EVR (3 out of 
7). Like rail sector businesses, NSAs see RINF as the most difficult to use with half of the 
respondents disagreeing with this statement (5 out of 10). 

Concerning the extent to which the registers are tailored according to the users’ needs, the 
view of NSAs is relatively more negative than that of the rail industry. A majority of NSAs 
that replied disagreed with registers and IT tools being tailored to user needs for ERADIS 
(7 out of 12), RDD (8 out of 13), ECVVR (8 out of 10) and EVR (5 out of 8). The level of 
disagreement was lower for SRD (3 out of 9) and RINF (3 out of 9). 

In this context it should be noted that less positive assessments by stakeholders were mostly 
associated with significant delays in the development of some registers.  

There are some major limitations being reported by register users that participated in the 
survey,  in  particular  for  RINF  and  SRD,  indicating  that  these  registers  are  not  fully 
delivering the expected outcomes in terms of facilitating route compatibility checks65 and 
providing clarity on applicable national rules, respectively.  

The main criticism concerns the similar data being required by different EU rail registers 
such  as  ERADIS,  ERATV,  and  EVR  due  to  a  lack  of  integration.  The  users  have  to 
introduce the same data in the various registers, which leads to complexity, increased cost 
of sharing data across platforms and potentially higher data errors. While this duplication 
can create some administrative burden for the users, the evaluation shows that it does not 
critically affect the overall harmonisation in the rail sector. 

Overall, concerning the second objective, ERA has not fully delivered a high level of 
technical, operational and safety harmonisation in the railway sector, due to not meeting 
in  full  its  objective  of  screening  and  effectively  removing  obsolete  national  rules,  the 
limitations concerning the monitoring of NSAs and NoBos as well as the delays in setting 
up registers and their lack of integration.  

In  addition  to  the  above,  several  types  of  technical,  operational,  administrative  and 
infrastructural issues pose challenges to interoperability and represent barriers to rail cross-
border  traffic.  The  absence  of  a  structured  EU-wide  mapping  of  cross-border 

65 The objective is to check if a certain railway vehicle (read as a locomotive unit, passenger car, wagon, etc) 
of an authorized type of vehicle, can travel the route from operational point A to operational point B. Each 
route is composed of sections of lines (tracks) with different technical parameters. Each track is between two 
operations points. 

47 

 
 
interoperability bottlenecks does not allow targeted action and systematic monitoring of 
the progress towards seamless rail operations. An example of operational harmonisation 
challenge  is  when  compliant  ERTMS  solutions  in  neighbouring  Member  States  fail  to 
work together effectively, as a result of deploying without the cross-border objective in 
mind.  

Concerning  the  third  objective  of  supporting  rail  sector  competitiveness  and 
innovation  deployment  by  reducing  administrative  costs  of  authorisation  processes, 
operating and running rail service and reducing time to market for innovation, the Agency 
has effectively delivered several activities and outputs intended to promote innovation 
(development/update  of  TSI,  active  support  of  Europe’s  Rail  Joint  Undertaking  (EU-
RAIL))  and  has  put  together  the  new  harmonised  vehicle  authorisation  and  safety 
certification process.  

The Agency had a positive role through its involvement in EU-RAIL (and before that the 
Shift2Rail JU) by identifying relevant research and innovation topics/themes to be pursued 
by EU-RAIL in the context of the development of SERA, providing input to ensure that 
interoperability and safety considerations and the experience from the TSIs are taken into 
account  in  the  development  of  new  technologies  and,  more  recently,  through  its 
involvement  in  the  preparation  of  the  System  Pillar  of  EU-RAIL.  According  to  the 
representative of EU-RAIL, ERA has contributed to the higher adoption / market uptake 
of new technologies and digitalisation (specifically in relation to the introduction of ETCS 
and specifications related to the TSIs), the higher degree of digitalisation in the sector (in 
terms  of  update  of  the  Control  Command  and  Signalling  (CCS)  and  TSI  relating  to 
telematics  applications  for  passengers/freight    (TAP/TAF)  TSIs),  as  well  as  to  the 
improved  time  to  market  for  the  deployment  of  rail  innovation  and  the  lower  cost  of 
deploying rail sector innovation. 

It was mentioned by the representative of EU-RAIL that ERA’s support can accelerate the 
authorisation process as the Agency is already aware of the technical developments and 
can  plan  regulation  changes  accordingly.  This  improves  the  competitiveness  of  the  rail 
sector. However, 20 out of 35 respondents to the survey in the context of the evaluation 
support study were rather sceptical concerning the contribution of ERA activities towards 
rail sector competitiveness and innovation deployment. 8 out of 15 authorities provided a 
negative view and 5 out of 9 railway sector representatives were also sceptical, indicating 
a contribution to limited extent and 4 more to some extent.  

There was also similar scepticism concerning the contribution of ERA activities towards 
reducing the time to market with only five of 32 respondents indicating ‘completely’ or ‘to 
a  significant  extent’.  Among  NSAs,  three  out  of  eight  indicated  not  at  all  or  only  to  a 
limited extent and four to some extent. Among national authorities, nine indicated to some 
extent and four provided a positive assessment. Railway sector representatives were also 
in general sceptical about ERA activities towards reducing the time to market, with five 
out of nine indicating that ERA contributed to a limited extent and four to some extent.  

The explanations provided for these answers included that any assessment of impact on 
innovation  is  rather  premature,  given  the  early  stages  of  the  implementation  of  the  4th 
Railway  Package,  although  important  part  of  the  work  related  to  the  promotion  of 
innovation took place even before the adoption of the 4th Railway Package. However, for 

48 

 
the majority that provided a negative assessment the main criticism was the alleged higher 
time  and  costs  for  authorisation  and  certification  that  is  identified  as  an obstacle  in  the 
uptake of new technologies.    

These obstacles may in part be explained by some limitations in the operation of the ERA 
Working Parties that – due to their focus on ensuring the largest possible consensus – have 
not always been equally effective in integrating change and innovation in the adopted TSIs.  

Assistance to Member States, candidate countries and stakeholders: Article 43 of the 
ERA Regulation stipulates that the Agency “shall engage in training and other appropriate 
activities concerning the application and explanation of railway safety and interoperability 
legislation and related products of the Agency such as registers, implementation guides 
and  recommendations”  at  the  request  of  Commission,  Members  States,  candidate 
countries,  networks  of  NSAs  or  representative  bodies.  This  should  allow  candidate 
countries to become fully acquainted with the 4th Railway Package, stay in touch with the 
latest  developments  regarding  the  sector  in  general  and  promoting  a  safety  culture.  In 
principle, the costs of such assistance to third countries shall be borne by the requesting 
party (in line with Article 43 of the ERA Regulation). However, this does not translate in 
an adequate increase in  the number of  FTEs  for  ERA who therefore cannot  meet  these 
obligations in full. To be noted that these activities were not included in the 2013 Impact 
Assessment and therefore, there were no estimates concerning the resources needed.  

Outside the EU, via the IPA programme, the Agency has delivered support to the NSAs 
of the Western Balkans – mainly in the form of “soft” actions including capacity building 
and  knowledge  exchange  –  to  promote  convergence  with  the  EU  railway  safety  and 
interoperability legal framework. Overall, the stakeholders that provided input on this topic 
(namely from the  Serbian Directorate for Railways,  the  Transport Community (TCT)66, 
and DG NEAR) gave a positive assessment of ERA’s role and its delivery of its’ goals 
through the Pre-accession Instrument (IPA) project, with focus on bringing the Western 
Balkans railway system closer to the EU state of play. This has been achieved by allowing 
the  regional  railway  institutions  and  experts  to  become  fully  acquainted  with  the  4th 
Railway Package, stay in touch with the latest developments regarding the sector in general 
and promoting the safety culture. At the same time, they pointed to some limitations to the 
delivery of activities by ERA, in particular: 

•  Budgetary  and  resource  constrains  on  the  side  of  the  Agency  meant  that  not  all 
workshops initially planned were delivered and that, among those delivered, some were 
reduced in size with a smaller number of beneficiaries – representatives of the NSAs - 
being able to attend. For example, to implement the IPA Programme the Agency has 
received, for each period of the contract, between EUR 200 000 and EUR 450 000 with 
a total of around 1 FTE allocated for the implementation of the IPA programme for 
both  2020  and  2021.  The  latter  is  lower  than  what  was  projected  in  the  Agency’s 
programming documents (2 FTEs in 2020 and 3 FTEs in 2021). 

•  The  TCT  and  the  Serbian  Directorate  for  Railways  commented  that  the  COVID-19 
pandemic  caused  delays  in  the  implementation  of  the  Rail  Action  plan  and  the 

66 Treaty concluded between the Union and South European Parties (i.e., Albania, Bosnia and Herzegovina, 
-  https://www.transport-
the 
community.org/wp-content/uploads/2022/10/treaty-en.pdf 

former  Yugoslav  Republic  of  Macedonia,  Kosovo  and  Serbia) 

49 

 
 
cancellation  of  some  training  activities  (i.e.  training  courses  on  risk  management; 
SMSs) while others had to be delivered online.   

Resourcing issues from the side of the Agency together with the practical implications of 
the COVID pandemic have posed some limitations to the delivery of the IPA programme, 
hence impacted on the Agency’s ability to deliver assistance to Member States, candidate 
countries and stakeholders.  

In addition, the recent geopolitical developments further show the strategic importance of 
integrating new accession countries such as Ukraine and Moldova in the EU rail system. 
There is a pressing need to speed up the cooperation with candidate countries in mirroring 
the EU processes for VA and safety certification. The under-resourcing directly impacts 
the  Agency's  ability  to  meet  its  obligations,  leading  to  reduced  delivery  on  planned 
activities. 

When  it  comes  to  its  fourth  objective,  the  Agency  has  been  largely  successful  in 
performing  its  role  as  the  Union  authority  responsible  for  issuing  authorisations  for 
placing in the market railway vehicles and vehicle types, SSCs for railway undertakings, 
and issuing ERTMS system approvals. In that respect, ERA successfully developed the 
necessary infrastructure and mechanisms to ensure that it was ready to assume its role by 
June 2019 and has since then rather effectively delivered on this role. There have not been 
any  major  disruptions  to  the  development  and  operation  of  the  OSS;  the  input  from 
stakeholders is positive concerning most of its features.  

Responses from three of the stakeholder groups (NSAs, railway sector representatives and 
railway businesses) were similar, with over half (7 out of 13 NSAs, 5 out of 9 railways 
sector representatives and 107 out of 185 railway businesses) agreeing that the operation 
of the dual system meets the needs of the railway sector. Nonetheless, there was also a 
sizeable share which appeared more sceptical. National authorities were more supportive 
of this, with all 17 that replied indicating agreement with this statement. At the same time, 
8  out  of  185  railway  businesses  considered  the  dual  system  complicated,  long  and 
expensive  with  duplication  in  documentation  required  across  ERA,  NSAs  and  NoBos 
adding  to  the  costs  for  railway  businesses  and  indicating  that  the  process  should  be 
shortened and simplified. While this represents a small proportion of respondents, it signals 
that some businesses experience administrative  burden, and that simplification could be 
beneficial.  As  an  example,  redundant  national  rules  which  overlap  with  TSIs  are  an 
important  factor  that  increases  the  processing  time  of  applications.  Since  national  rules 
have to be reviewed by NSAs even in applications submitted to ERA, the sole existence of 
redundant  national  rules  increases  the  complexity  of  the  process  and  processing  time 
unnecessarily.  

The Agency has always met the respective legal deadlines for processing of the respective 
applications and the granting of authorisations and certification. This should be considered 
in the context of a high number of applications for authorisation and certification submitted 
and the fact that a high share of them were approved. In all cases, but particularly in relation 
to CTT authorisations, the number of applications to ERA has been significantly higher 
than  those  initially  expected  by  the  Agency  for  the  initial  period.  Nonetheless,  ERA 
managed  to  respond  by  re-allocating  resources  from  the  policy  related  tasks  to 
authorisation tasks despite significant resource constraints.  

50 

 
The  increasing  share  of  single  country  applications  for  CTT  –  circa  18%  in  2021  – 
submitted directly to ERA rather than to the NSAs, is seen as an expression of the high 
confidence towards the Agency performance, as well as an indication of the preference for 
having  a  single  interlocutor  for  both  single-country  and  multi-country  applications.  A 
significant  share  of  respondents  to  the  surveys  (48  out  of  78  in  the  case  of  vehicle 
authorisations and 53 out of 78 for safety certifications) indicated preference to use ERA 
– instead of NSAs – for single-country applications, due to expectation that ERA process 
would  be  more  structured  and  predictable  concerning  the  outcome.  Most  railway 
businesses  that  replied  (38  out  of  71)  provided  a  positive  assessment  concerning  the 
predictability of the outcome of the process. 

Ten out of 17 national authorities that expressed a view indicated that ERA was either quite 
effective or very effective in its role concerning authorisation and certification. The railway 
sector representatives considered that ERA was only somehow effective when it comes to 
VAs, while 6 out of 9 did not have an opinion on safety certification. The explanations 
provided by the representatives of the railway sector were related to the legal requirements 
set  by  the  4th  Railway  Package  as  well  as  on  the  allegedly  strict  and  demanding 
interpretation of those requirements by the Agency.  

As described in section 3, the Agency cooperates with the NSAs in the processing part of 
applications, based on cooperation agreements signed with all NSAs before the target date 
of 31 October 2020. This new model based on cooperation between ERA and NSAs in the 
processing part of applications enables an effective transfer of knowledge from the Agency 
to  the  NSAs  and  helps  harmonising  approaches  on  certain  aspects.  It  supports  also  the 
creation of a network of experts working on similar aspects who can reach out to  other 
members of the network where relevant.  

However, there are some challenges which require mention/attention. The Agency is often 
faced with serious difficulties in complying with internal project milestones or even legal 
deadlines when processing applications as a result of late inputs coming from the NSAs. 
There  have  been  repeated  situations  when  NSAs  communicated  issues  linked  to  the 
assessment of national parts of applications very late in the overall process, when most of 
time  available  for  assessment  has  already  elapsed.  This  results  in  extension  of  the 
timeframe and delays for the applicants.  

In case of applications for SSCs, some NSAs do not provide the necessary feedback from 
their  supervision  activities.  The  Agency  is  therefore  unable  to  target  its  assessment  at 
aspects which cause problems in practical implementation. This limits the ability of the 
sector to learn from experience and to ensure continuous improvement of its SMSs.  

As regards the question whether the working practices of the Agency as set out in the ERA 
Regulation  are  sufficiently  supporting  the  Agency’s  objectives  and  sector  needs,  the 
analysis of the work  and operations of the  Working  Parties suggests that, through their 
outputs, they had a positive contribution towards achieving the Agency’s objectives on the 
effective  implementation  of  railway  safety  and  interoperability  legislation.  The 
development  of  recommendations  for  TSIs  and  CSMs  by  the  Working  Parties  were 
generally considered of good quality and in line with the needs of the sector.  

All in all, the analysis of the level of participation in the Working Parties suggests that the 
most directly affected stakeholders – including both from the authorities and the industry 

51 

 
perspective – are directly involved while others are involved on a case-by-case basis. There 
is  no  indication  of  practical  barriers  to  participation  set  by  the  design  of  the  Working 
Parties and of any explicit selection process. Resource constraints and absence of relevant 
expertise  are  the  most  common  reasons  limiting  some  stakeholders  and  national 
authorities’ representation. 

Factors affecting the Agency’s achievement of its objectives 

The  two  most  important  factors  hindering  ERA’s  performance  and  achievement  of 
objectives  were  the  resource  limitations  linked  to  the  Union  contribution  and  the 
establishment plan, and the higher-than-expected  workload for the delivery of authority 
tasks. The resulting  prioritisation of authority  tasks impacted the delivery of its  policy-
related tasks aimed at eliminating operating barriers and addressing the fragmented set of 
national  rules.  Beyond  that,  performance  issues  of  some  NSAs  and  limitation  in  their 
cooperation  with  the  Agency  have  negatively  affected  ERA’s  ability  to  achieve  its 
objectives. Both aspects are considered work in progress. Similarly, the varying level of 
performance of NoBos across the EU also has an impact on the delivery of the activities 
and the objective to reduce administrative costs.  

The delayed and staged transposition of the 4th Railway Package seemed not to have had a 
significant impact on the Agency performance and achievement of objectives beyond some 
initial challenges.  

Concerning the role of external factors, the COVID-19 pandemic posed specific challenges 
to the Agency’s ability to deliver its tasks; nonetheless, the evidence suggests that ERA 
effectively  responded  to  them.  There  are  no  indications  or  input  from  stakeholders 
suggesting any important negative impacts of the pandemic specifically on the Agency’s 
delivery of its authority tasks. The OSS had been designed to manage all the exchanges 
between  concerned  actors  fully  electronically  ensuring  minimum  level  of  disruption. 
Furthermore,  the  Agency  effectively  moved  to  remote  working  and  the  use  of  virtual 
meetings to support the delivery of the policy related work (including the NSAs and NoBos 
monitoring) while some other activities – mainly related to the IPA and EUR Med Rail 
project  as  well  as  delivering  assistance  to  Member  States,  candidate  countries  and 
stakeholders – were postponed to 2022, as explained above. Technological developments 
and trends in the sector also appear to be ongoing challenges - rather than hindering factors 
- to which the Agency has been able to respond as part of its objective to support innovation 
deployment and promote harmonisation, albeit with limitations associated with the role of 
the working parties in integrating change and innovation.  

In comparison, market trends – and specific railway sector business decisions – have led 
to high number of authorisation applications (particularly conformity to type) that posed 
important  resourcing  challenges  to  the  Agency.  As  mentioned  above,  the  prioritisation 
given to the authority tasks and to achieving the objective of performing the role of the 
Union authority has negatively impacted the delivery of the other objectives. 

No unexpected effects outside those already considered as directly or indirectly resulting 
from the Agency activities were identified. 

52 

 
Efficiency  

Concerning ERA’s use of actual resources, based on data from the annual activity reports 
covering the period 2016-2021, the Agency has allocated around 850 FTEs with a total 
expenditure of around EUR 136.7 million to support the preparation and delivery of all the 
relevant activities to implement the 4th Railway Package.  

More specific data on the preparatory actions of the 4th Railway Package activities related 
to the authority tasks (including the development of the OSS and the various supporting 
activities) suggest a total of around 57-72 FTEs with a budget of EUR 10.5 to 12.5 million 
for  the  period  up  to  June  2019.  Not  including  any  support  activities,  since  June  2019, 
around 223 FTEs have been directly allocated to the implementation of the 4th Railway 
Package  authority  and  policy  activities  with  a  total  budget  of  EUR  35.7  million.  This 
includes 87 FTEs allocated for the delivery of the authority tasks and 136 FTEs for the 
policy tasks.  

The Agency largely mobilized the necessary human and financial resources for delivering 
its new authority tasks, but this was largely the result of ERA’s prioritisation of the delivery 
of the new authority tasks over the policy related tasks, with a corresponding reallocation 
of resources. This reallocation delayed the delivery or reduced the scope of other important 
Agency tasks under ERA Regulation, most notably the monitoring of NSAs and NoBos as 
well as the screening and removing of obsolete national rules (see Sections 3 and 4). Due 
to  budget  constraints,  important  activities  such  as  the  development  of  the  Safety 
Information  Sharing  System  (ISS)  and  the  analysis  of  consistently  collected  data  on 
accident precursors had to be put on hold.  

Once adopted67 and fully implemented, CSM ASLP will enable the development of railway 
safety  in  a  genuine  prevention  mode  of  accidents  and  of  their  causes.  It  will  convert 
monitoring  of  accident  outcomes  into  monitoring  of  the  causes  of  accidents  and  the 
prevention  of  occurrence  with  collective  learning  and  actual  prevention  processes. 
However,  the  successful  and  smooth  implementation  of  the  CSM  will  be  strongly 
influenced by the availability of the Safety Information Sharing System.  

The current formats and tools on railway safety occurrence reporting are not technology-
proof and the expectation on future better common safety methods for occurrence reporting 
in  Europe  is  not  matched  by  an  appropriate  enabling  tool.  This  prevents  the  EU  from 
having a pro-active system of learning from failures before they turn into accidents and 
incidents. 

This was necessary given that, since the adoption of the 4th Railway Package, ERA has 
faced the challenge of an establishment plan cap and limits to the capacity for recruiting 
of  additional  resources,  together  with  an  increasing  demand  for  authority  related  tasks 
alongside an ongoing and increasing demand for the policy related tasks. Moreover, the 
Agency  is  faced  with  an  internal  competition  over  the  same  limited  pool  of  technical 
expertise to  cover, on one hand, the policy support for the key rail interoperability and 

67 Adoption expected for 2026 

53 

 
 
safety objectives and, on the other hand, the time-bound delivery of VAs and SSCs, with 
critical impact on the competitiveness of rail operations in Europe. 

ERA estimations from 2024 show an increasing workload in the field of the authorisation 
tasks (see Figure 26 and Figure 27), especially linked to the ambitious ERTMS onboard 
retrofitting programmes including Automatic Train Operation (ATO) and Future Railway 
Mobile Communication System (FRMCS) and DAC rollout programmes in Europe. The 
Agency and the NSAs will face high pressure to allocate appropriate resources to these 
vital tasks. 

Figure 26. Estimated increase in vehicle authorisations 

Figure 27. Estimated increase in Single Safety Certificates 

The responses to the surveys largely support the view (as well as the input provided by the 
Agency itself) that resources limitation mainly affect the delivery of the policy related roles 
and responsibilities for which there are no legally set deadlines.  

The  responses  provided  to  the  surveys  show  a  clear  agreement  among  all  stakeholder 
groups that the Agency has insufficient resources to deliver on the screening of national 
rules and even less in relation to the monitoring of NSAs.  

In  contrast,  most NSAs  (6 out  of 11) that  contributed to  the survey  considered that the 
Agency has had sufficient resources to deliver on the processing of applications and the 

54 

 
 
 
operation of OSS. This view is not shared by most national authorities (8 out of 12) and 
railway  sector  representatives  that  shared  their  views  (8  out  of  8),  where  comments 
provided  suggest  that  budget  cuts  had  a  negative  impact  on  most  domains.  National 
authorities  referred  to  examples  concerning  both  the  OSS  operation  and  pointed  to  the 
significant  time  needed  to  address  issues/problems  reported  in  some  cases  while 
representatives of railway equipment manufacturers and wagon keepers (UNIFE (Union 
of  European  Railway  Industries),  UIP)  considered  that  the  resource  limitations  have  a 
negative impact in the delivery of all Agency’s tasks.  

This  analysis  suggests  that  these  stakeholder  concerns  are  largely  valid,  as  ERA’s 
prioritisation of authority tasks over policy tasks and resource constraints have had tangible 
effects  on  the  efficiency  of  certain  processes,  such  as  timely  monitoring  of  NSAs  and 
NoBos and the screening and removal of outdated national rules. 

Furthermore,  the  resource  limitation  had  other  implications,  for  example  the  OSS 
development was delayed and linking of registers (ERADIS, ERATV) with the OSS was 
not  as  extensive  as  initially  planned.  The  OSS  and  the  relevant  registers  do  not 
automatically communicate to each other, and do not use documents in machine-readable 
formats  but  pdfs. As a  result,  human intervention is  required to assess the information, 
which leads to duplicate content, increases the level of documentation required from the 
applicants, and slows down the overall process, thereby reducing its efficiency.  

On  the  Agency’s  capability  and  flexibility  to  rapidly  respond  to  resource  needs  due  to 
uncertainties related to  the  different  transposition dates of the technical  pillar of the 4th 
Railway  Package,  there  was  no  evidence  suggesting  that  significant  resourcing 
issues/challenges  have  been  experienced  due  to  uncertainties  arising  from  the  delayed 
(multiple) transposition dates by Member States.  

The analysis of the  Agency’s HR procedures points  to  various efforts for an effective 
response  to  this  human  resource  challenge  with  different  levels  of  success.  From  the 
recruitment  perspective,  the  Agency  faced  difficulties  in  fully  implementing  the 
establishment plan, especially in the period 2017-2018 where coverage was less than 90%. 
This has been improved and the implementation of the establishment plan reached 96% in 
2021. The Agency has also outsourced some of the authority related workload using the 
pool of experts, although this has also not delivered the level of resources expected, putting 
further pressure on ERA resources.  

Overall, in view of the challenges posed, the analysis suggests that existing HR procedures 
have had a positive contribution towards supporting the delivery of ERA’s responsibilities. 

On the efficiency of the working methods as set out in Chapter 2 of ERA Regulation, the 
analysis  of  the  costs  of  the  working  methods  and  the  resulting  outputs  did  not  point to 
significant  inefficiencies.  Some  comments  from  stakeholders  concerned  potential 
opportunities to improve the efficiency of working parties. The Commission and oneNSA 
pointed out that there may be room for reducing the time needed for a recommendation if 
there was less emphasis by ERA on reaching a consensus among all involved and if ERA 
adopted a more assertive top-down approach, coming up with specific solutions aiming to 
steer the working parties towards what’s needed in less time.  

55 

 
On the cost-efficiency of the organisation and management of the Agency, the analysis 
indicates  that  there  have  already  been  improvements  made  in  terms  of  the  share  of 
resources allocated to administrative tasks. Still, ERA compares unfavourably in relation 
to other EU Agencies in terms of the share of non-operational resources allocated (Table 
6). This is partly a reflection of the fact that, as all decentralised Agencies, ERA must fulfil 
a set of administrative functions which are independent of the size and type of operations 
delivered.  

Table 6. Analysis of ERA's share of non-operational staff, 2016 and 2019 - 2021, compared 
to other 6 EU agencies 

Agency 

ERA 

EASA 

EMSA 

ECHA  

ENISA 

EEA 

EIOPA 

Total 
number of 
staff (2021) 

Share of 
non-
operational 
staff (2016) 

Share of 
non-
operational 
staff (2019) 

Share of non-
operational 
staff (2020) 

Share of non-
operational 
staff (2021) 

184 

731 

252 

586 

76 

213 

166 

29.8% 

18.1% 

29.0% 

25.4% 

33.3% 

22.6% 

24.5% 

30.4% 

15.9% 

28.4% 

20.3% 

29.5% 

18.2% 

21.4% 

28.4% 

16.0% 

28.0% 

19.9% 

26.71% 

20% 

18.3% 

25.8% 

20.9% 

n.a. 

19.2% 

35.5% 

15% 

16.1% 

Source: Ricardo Evaluation support study 2023 

The Agency introduced a number of changes in 2018 including  a new organisation and 
operation  structure  with  a  new  organigram68,  with  the  aim  of  making  the Agency  more 
effective,  efficient  and better tailored to  its  new  roles and responsibilities. ERA moved 
from clearly defined units focusing on different aspects of its work and working largely 
independently  (Interoperability  Team,  Safety  Team  and  Economic  Team  (including 
ERTMS)) to a more integrated organisational structure, following a matrix approach that 
has provided greater flexibility in the allocation of resources and response to fluctuations 
in the demand for authority activities (putting aside the possible negative implications).  

ERA  has  adopted  an  efficiency  strategy  aiming  to  identify  possible  efficiency  gains  to 
address resource constraints. It also identified a range of measures and actions to deliver 
in this area and introduced monitoring tools to help assess its effectiveness and efficiency 
and take corrective action. The Strengthening Plan adopted in 2022 has identified areas 
where there is scope for further efficiency gains that are necessary in view of the resource 
constraints faced by the Agency. In this effort, the Management Board – as the supervising 
entity - has played an active and constructive role, being actively engaged in the definition 
of  a  new  intervention  logic  of  ERA  intended  to  more  effectively  link  the  Agency’s 
activities with its objectives.  

The role of the Management Board69 in ensuring the efficiency of the Agency is seen by 
its  members  and  railway  sector  representatives  as  positive,  primarily  through  its 
collaborative scrutiny of the SPDs and screening of the proposed annual budget. The SPD 

68 https://www.era.europa.eu/agency-you/agency/organisation_en 
69 The Management Board is defined in Section 1.1 

56 

 
 
for  year  N  includes  a  multi-annual  work  programme  covering  years  N,  N+1  andN+2, 
together  with  the  annual  programme  for  year  N.    The  Agency  implements  its  work 
programme following the principles of the intervention logic, in line with the guidelines 
provided by the Network of EU Agencies. The intervention logic supports the Agency by 
emphasising  the  desired  changes  and  the  road  to  its  achievement.  It  is  also  a  thinking 
process  supporting  the  Agency  to  design,  reconsider,  and  adapt  its  outputs  to  the  most 
effective one for a determined outcome. 

The  Management  Board  discusses  and  endorses  the  SPD  for  the  year  N  by  the  end  of 
November year N-2. The SPD is then submitted to the Commission who should adopt the 
Opinion by 1 July of year N-1. ERA then revises the SPD in line with the Commission 
Opinion and the Management Board adopts the SPD for the year N by the end of November 
year N-1. 

The  Management  Board  also  actively  supported  the  Agency  in  the  development  of  the 
Strengthening Plan in its effort to identify efficiency gains to address identifying where 
resources can be reallocated to help meet the Agency’s objectives.  

Input from stakeholders with relevant experience suggests that the supervisory role of the 
Management Board was positive. National authorities  – a large share of which are also 
members  of  the  Management  Board  –  believe  that  it  has  contributed  to  the  efficient 
operation of the Agency (13 out of 14), while a slightly lower  number thought that the 
quality  of  monitoring  of  the  Agency  by  the  Management  Board  had  a  positive  role  on 
delivery of Agency’s responsibilities and achievement of its objectives (9 out of 12). None 
of the national authorities believed that the Management Board had a negative role on the 
efficient  operation  of  the  Agency.  Comments  provided  by  the  Belgian  representative 
referred  to  the  positive  role  of  the  presence  of  a  dashboard  that  allows  management 
members  to  closely  monitor  the  Agency’s  performance  although  some  authorities  (e.g. 
Sweden) considered that the level of involvement of the Management Board goes beyond 
the objectives of a long-term strategic development and could be seen as too detailed and 
possibly counter-productive.  

NSAs that responded to the survey largely indicated that they did not have a view on the 
Management  Board’s  impact  (6  out  of  13),  but  most  of  those  that  did  have  an  opinion 
agreed that their impact was positive (4 out of 13). Among railway sector representatives, 
all seven that provided a response agreed or strongly agreed that the process contributed to 
the efficient operation of the Agency. 18 out of 25 respondents to the survey (including 6 
out of 7 railway sector representatives, 3 out of 7 NSAs and 9 out of 12 national authorities) 
considered  that  the  Management  Board  had  a  positive  role.  In  comparison,  survey 
respondents  appeared  more  sceptical  of  the  role  of  the  Agency  organisation  and 
management structure with only 8 out of 21 suggesting a positive role and 4 of them  – 
including two railway sector representatives and two authorities – stating that it actually 
had a negative role. However, there were no specific explanations provided as to what is 
the  underlying  reason  for  such  a  negative  assessment.  It  can  only  be  inferred  that 
stakeholders  consider  that  there  is  scope  for  further  improvements  to  the  Agency 
management and organisation. 

One potential inefficiency identified based on stakeholders input is that the current role of 
the Executive Board could be considered a duplication of the work of the Management 

57 

 
Board, in the sense that the Executive Board cannot take decisions and, as it is currently 
organised, it does  not  help  reduce the workload  of the Management  Board in  decision-
making.  However, this perception could stem from lack of awareness concerning the role 
of the Executive Board.  

The Executive Board’s main function is to assist the Management Board, in particular, by 
preparing the decisions to be adopted by it, to ensure an adequate follow up to the findings 
and recommendations after investigations and the various internal or external audits. For 
this reason, the same Management Board Decisions are on the agenda of the meetings of 
both  Executive and Management Board, however with  a different purpose. Further, the 
Executive Board supports and advises the Executive Director in the implementation the 
Management Board decisions, with a view to reinforcing supervision of administrative and 
budgetary management.  

Further, as stipulated in the ERA Regulation, where necessary, on grounds of urgency, the 
Executive  Board  can  take  certain  provisional  decisions  on  behalf  of  the  Management 
Board, in particular on administrative and budgetary matters, subject to a mandate received 
from the Management Board. 

The external supervisory mechanisms of the Agency have all contributed positively to 
the efficiency of the Agency: 

•  The European Commission has had a positive role through its close supervision of the 
Agency’s annual planning and budgeting processes, and guidance on the prioritisation 
of scarce resources in the implementation of 4th Railway Package.  

•  The Internal Audit Service has investigated and provided actionable recommendations 
to  the  Agency  on  how  to  reduce  inefficiencies  in  specific  areas,  including  human 
resources  management,  project  and  service  management,  and 
information 
management. These recommendations were mostly accepted by the Agency and have 
contributed to improving efficiency.  

•  The  European  Court  of  Auditors  has  reviewed  the  Agency’s  accounts  each  year, 
providing  recommendations  to  improve  the  procurement  processes  and  the  internal 
control  of  ERA.  However,  their  assessment  focuses  more  on  the  accuracy  of  the 
Agency’s  accounts  and  the  appropriateness  of  its  processes,  rather  than  sources  of 
efficiency gains in human resource management.  

•  The 4th Railway Package Steering Group provided some benefit to Agency efficiency 
by  collecting  relevant  stakeholder  inputs  on  the  implementation  of  the  4th  Railway 
Package and improving the coordination between ERA and other rail stakeholders. 

As regards the impact of the ERA having a dual seat in Valenciennes and Lille on its 
working methods and its costs, there is no evidence of any significant cost implications 
from the dual seat. The costs related to maintaining the Agency’s presence in both locations 
only had a small impact on ERA’s resources and costs, representing around 0.3% of ERA’s 
total  budget  in  2021. At the same time, maintaining  premises in  Lille  –  which is  much 
more accessible (via train) and has greater accommodation options – is convenient and less 
costly for the Management Board members and other external experts and stakeholders 
participating in working groups. There is no indication that it has any negative impact on 
the effectiveness of the delivery of the Working Parties. More importantly, following the 

58 

 
COVID-19  pandemic,  most  recent  meetings  have  taken  place  online,  leading  to  a 
significant reduction in  costs. This is expected to continue in a hybrid format, allowing 
ERA to cut down on rental costs and travelling expenses for both staff and stakeholders.  

On the aspects/means/actors/stakeholders or processes rendering ERA efficient, the 
Agency has gradually introduced internal processes and a management system that helps 
monitoring the use of its resources. ERA had taken a range of measures even before the 
adoption  of  the  4th  Railway  Package  towards  improved  efficiency  of  its  operations, 
including the implementation of an Integrated Management System and the establishment 
of  more  thorough  internal  control  process.  Furthermore,  the  Agency  has  put  in  place  a 
process  of  monitoring  its  performance  against  the  targets  set  in  the  SPDs  supported  by 
systematic  data  collection  on  the  resources  used,  budget  allocations  and  performance 
indicators. The Strengthening Plan adopted in 2022 suggests actions focusing on increased 
digitalisation and leaner internal processes, which according to ERA’s estimations can be 
expected  to  bring  around  1%  efficiency  savings  annually,  namely  around  1.9  FTE 
additional savings on an annual basis with internal redeployment and move of staff from 
administrative to operational activities bringing up to 4 FTE annually. […..] Furthermore, 
the Strengthening Plan has identified areas where there is scope for further efficiency gains 
that are necessary in view of the resource constraints faced by the Agency.  

In  2025,  the  Agency  has  amended  its  matrix  structure  to  move  from  69  projects  and 
services to 23 programmes (67% decrease). This resulted in overall administrative savings 
linked to activity management estimated at around 1 FTE. Moreover, 46 project managers 
were  assigned  to  operational  tasks  since  the  largest  majority  of  them  have  a  technical 
profile.  

Furthermore,  the  Agency  used  the  opportunity  in  2023  and  2024  to  amend  its 
Establishment  Plan,  in  agreement  with  its  Management  Board  and  the  Commission 
services. This allowed converting vacancies previously assigned to assistant administrative 
roles into administrator positions focused on operational areas under pressure.  

In addition, as reported in the Consolidated Annual Activity Reports, between 2023 and 
2024 ERA has reduced its administrative FTEs by 1.06% compared with the previous year, 
and increased its operational FTEs by 1.10%. This represents a net gain of 4.27 FTEs spent 
in operational matters in 2024, compared to 2023. This suggests that some of the expected 
efficiency gains from digitalisation and leaner internal processes are starting to materialise, 
allowing more staff time to be allocated to operational tasks. 

Furthermore,  the  FTEs  spent  on  “ERA  Management  and  Administration”  have  been 
steadily going down since 2023, freeing those resources to work on specific programmes 
and  tasks.  This  decrease  has  been  possible  through  the  streamlining  of  various  tools, 
including planning, monitoring and reporting. There has been an equally important effort 
to redirect some administrative tasks to operational ones such as vehicle authorisation.     

There  is  also  no  evidence  or  input  from  stakeholders  suggesting  that  other  aspects  and 
actors – including the operation of the working parties, the processes for monitoring NSAs 
and NoBos or the dual seat – have a clear positive or negative impact on the Agency’s 
efficiency.  

59 

 
On whether the Agency’s results/deliverables led to increased administrative burden, 
the outputs and deliverables of the Agency have not led to lower administrative burden for 
rail  businesses  so  far.  Increased  administrative  costs  linked  with  the  preparation  and 
submission  of  documents  for  VA  and  SSC,  and  increased  fees  charged  by  ERA  were 
identified as the main drivers of burden.  

According to stakeholders, the delivery of the vehicle authorisation and safety certification 
process did not lead to a reduction of the effort and costs. The expected reduction in the 
administrative burden for applicants has not materialised during the initial implementation 
period of the dual system for VA and safety certification. Rather, administrative costs are 
reported to be higher compared to those of the 3rd Railway Package by most applicants. 
An  important  driver  of  this  outcome  is  the  lack  of  familiarisation  of  rail  industry 
stakeholders with the new system. At the same time, it appears that these higher costs are 
related to the requirements of the 4th Railway Package legal framework rather than to the 
performance of ERA in implementing and managing those requirements. The level of fees 
applied  by  ERA  is  also  perceived  by  some  stakeholders  as  a  driver  for  increased 
administrative  costs  compared  to  the  previous  situation  in  some  cases.  The  ERA 
Regulation includes the requirement that ERA’s fees should be equal to or less than the 
average fees levied by NSAs. However, given the wide range of charging schemes applied 
by  NSAs,  it  is  likely  that  ERA  charges  are  perceived  as  being  higher  in  some  cases, 
especially  after  the  increase  of  the  hourly  rate.  This  feeling  is  particularly  keen  for 
applicants who specified that they previously paid no fees to the NSA (e.g. the French, 
Estonian and Latvian NSAs do not charge for safety certification) or instead paid a lower 
fixed fee to the NSA. The German and Dutch NSAs, for example, reported current hourly 
fees of EUR 120 and 129, respectively, while the previous study on fees and charges (Steer 
Davis Gleave, 2016) estimated that equivalent hourly fees were at most EUR 200 in some 
countries and significantly lower in Eastern Europe Member States (less than EUR 20)70. 

Another underlying reason for this effect is the Agency applying the legal requirements in 
a more systematic and consistent way than some NSAs did in the past.  

Further, there are issues related to OSS and with the IT tools including lack of register 
integration,  slow  loading  times,  the  time  needed  to  fill  out  a  mapping  table,  delays  in 
addressing technical issues when submitting the application that also explain the increased 
administrative costs. The stakeholders report an increased effort and time needed to upload 
copies of required documentation  and the lack  of effective links with  relevant  registers 
such as ERATV and ERADIS. Both of them are considered to be contributing to higher 
administrative burden for applicants.  

However, it is expected that the digitalisation of the application process (in comparison 
with the use of hard copies) as requested by some NSAs before the 4th Railway Package, 
should have introduced some savings in administrative costs.  

70 The study on fees and charges (Steer Davis Gleave, 2016) estimated hourly costs for NSAs as a proxy of 
their  fees.  This  is  considered  to  be  a  good  proxy  since  NSAs  are  not  expected  to  make  profit  on  their 
operations. 

60 

 
 
 
According to rail businesses, the main issue is the impact on costs/resources and time for 
the vehicle authorisation process as result of the implementation of the 4th Railway Package 
and less in relation to the safety certification or, even less, ERTMS trackside approval, due 
to a number of weaknesses of the requirements or the process, including the introduction 
of CTT and of new higher fees by the Agency71, unclear definitions or interpretations. The 
unfamiliarity of the applicants and authorisation entities with the new processes led to an 
increase in administrative costs, particularly during the transition period. 

ERA issues clarification notes with the aim of improving stakeholders understanding of 
complex  regulatory  requirements  and  technical  specifications,  ensuring  consistent 
interpretation and implementation across Member States. They serve as a practical tool to 
support  the  effective  and  harmonized  implementation  of  EU  railway  regulations. 
Clarification notes were  issued for  example to  foster a harmonised EU approach to  the 
safety certification process. The clarification notes provide non-legally binding guidance 
from ERA and the concerned stakeholders are encouraged to voluntarily apply it. Overall, 
the clarification notes proved useful for the sector in interpreting and implementing the 
legal requirements.  

However, railway representatives pointed to specific clarification notes72  issued by ERA, 
which might have interrupted running projects linked to vehicle authorisation procedures 
at short notice and add further requirements. In their view, these clarification notes were 
not subject to appropriate consultation and hence, it was not possible to prepare for and 
mitigate some of these additional costs. As these notes are not legally binding, they cannot 
add  any  additional  requirements  to  those  included  in  the  legislation.  Rather,  due  to  the 
clarification provided, the applicants become aware that they might have misinterpreted 
the  requirements  and  for  example  a  different  document  would  be  required  for  the 
application  file.  This  would  potentially  lead  to  the  interruption  of  the  authorisation 
procedure and increase the costs. Evidence collected indicates that the adoption of the dual 
system for vehicle authorisation and safety certification has not yet led to actual reductions 
in  processing time for the majority of authorisation  and certification applications. Most 
stakeholders  reported  that  time  to  market  (and  related  opportunity  costs)  has  increased 
during  this  initial  implementation  period,  particularly  for  first  and  new  vehicle 
authorisations, even though ERA has managed to deliver authorisation and certification 
within the legally binding deadlines.   

The ERTMS trackside approval process is still at the early stages, considering timescales 
are different compared to those of VA and SSC, and the evidence is limited. However, the 
initial feedback from stakeholders is mostly positive. As a negative aspect, stakeholders 
highlighted the extended scope of the approval process, beyond the TSI checks.  

The overall impact of the dual system for authorisation and certification, and the ERTMS 
trackside  approval  process  on  the  provision  of  cross-border  rail  services  also  lacks 
evidence for a conclusive answer. The analysis suggests however that the potential of the 

71 In comparison to those applied by NSA prior to the adoption of the 4th Railway Package for authorisation 
and certification processes. 
72  The  notes  mentioned  by  sector  representatives  were  the  Clarification  note  Authorisation  of  vehicles 
equipped  with  CCS  train  protection,  Clarification  note  from  the  29th  of  June  2021,  Clarification  note 
ERA1209/119 V1.0 - Authorisation of vehicles with ETCS set of specifications #1 

61 

 
 
new roles and processes in terms of facilitating cross-border services has not been fully 
exploited. 

The inputs to the targeted survey suggest an overall increase in the administrative costs 
incurred for both authorisation and certification activities in comparison to the situation 
before the 4th Railway Package:  

•  For new or first vehicle authorisations, the large majority of applicants that responded 
to the survey reported an increase in administrative costs (45 out of 62) and the required 
human  resources  (48  out  of  66).  Only  a  few  (6  out  of  62)  reported  a  decrease  in 
administrative costs.  

•  For safety certification, fewer applicants that responded to the survey reported increases 
in administrative costs, but still more than half of the responses indicated an increase 
(35 out of 61). Those observing an actual decrease were only 11 out of 61. 

Further, concerning the lack of familiarity with the new processes, as in some countries 
ERA’s enhanced role was only fully adopted in October 2020, some applicants were only 
beginning  to  apply  the  new  processes  at  the  time  of  the  targeted  survey  and  other 
consultation activities, which led to more time spent on preparing the applications.  

While  no  significant  administrative  or  adjustment  costs  were  identified  as  a  direct 
consequence of policy tasks, the lack of progress on some policy tasks, and in particular 
the insufficient  delivery  on  screening  and removing obsolete national  rules,  has  limited 
efficiency gains on authorisation and certification tasks. 

The four case studies73 analysed in the evaluation support study point to specific limitations 
of the new authorisation and certification processes, notably multi-country applications, 

The two first case studies present the experience of two large rail vehicle manufactures with 
locomotive and trainset authorisations. Large manufacturers tend to operate across the EU and 
are likely to benefit from multi-country authorisations issued by ERA. These manufacturers did 
not  report  any  benefits  in  terms  of  regulatory  costs  and  highlighted  a  few  limitations.  Most 
limitations  are  related  to  a  persistent  lack  of  harmonisation  of  railway  rules.  Both 
manufacturers indicated their preference for ERA as authorisation entity and expected a positive 
change in the next years.  

The third case study illustrates the experience with wagon authorisations. Since these vehicles 
tend  to  be  used  internationally,  one  would  expect  these  to  benefit  from  multi-country 
applications issued by ERA. Despite this, the case study does not show evidence of cost savings 
so far, but a persistent cost variability depending on the assessment criteria, which shows lack 
of coordination between authorities. 

The fourth case study illustrates a multi-country safety certification, which is also expected to 
benefit  from  multi-country  applications  issued  by  ERA.  This  case  study  shows  evidence 
provided by a consulted railway undertaking of actual cost benefits. These derive from  time 
savings of interacting with a single interlocutor (ERA), rather than multiple NSAs.  

73 Case study 1 – Locomotive authorisation; Case study 2 – Trainset authorisation; Case study 3 – Wagon 
authorisation; Case study 4 – Safety certification 

62 

 
 
 
 
but also to some strengths and benefits of the new procedures, with impacts on regulatory 
costs.  

Authorisation and certification costs reported under these case studies could not be used to 
reliably assess cost changes against the baseline, because of comparability limitation with 
the cost figures reported under the 2013 IA study. As such, there is no sufficient evidence 
on the basis of these case study costs to complement stakeholder views regarding impacts 
on regulatory costs for the industry. In terms of potential simplifications leading to cost 
reductions, a streamlined procedure for extending the area of use of old vehicles was for 
example suggested by the case studies to reduce the burden of these authorisations.   

On whether the role of the Agency in terms of supporting harmonisation through TSIs 
and  CSMs  and  the  elimination  of  national  rules  brought  savings  for  both  authorisation 
entities and rail businesses, progress was made in both areas and the TSIs activity reduces 
costs  by  ensuring  a  single  set  of  EU  specifications  for  manufacturers  rather  than  many 
national  ones,  however  it  was  difficult  to  estimate  the  actual  cost  savings  during  the 
evaluation period. 

This may be related to the fact that these cost savings can only be indirect and take place 
in the long term. In addition, delays in the process of harmonising national rules and the 
development  of  relevant  registers  such  as  the  SRD  have  limited  the  impact  of  these 
activities  up  to  this  point.  The  costs  in  VAs  are  further  increased  by  the  remaining 
redundant national rules  – those that are often more controversial.  Current practices of 
some  Member  States  to  transfer  national  rules  to  other  documents  such  as  Network 
Statements  or  company  policies  limit  the  effectiveness  of  the  clean-up  programme  and 
related cost savings. 

On how the actual effects and positive impacts compare to the actual costs and any negative 
impacts in terms of orders of magnitude/in size, the data limitations and the inability to 
quantify the costs and benefits for the railway sector mean that it is not possible to provide 
a clear answer as to whether the costs and benefits are comparable in terms of order of 
magnitude.  

Evidence collected from potentially affected stakeholders points to the presence of some 
negative impacts in terms of additional costs for rail businesses and relevant authorities. 
The new authorisation  and certification process  and the clean-up of national  rules were 
identified by stakeholders as areas with potentially higher negative impacts. 

For  the  railway  sector,  the  total  costs  associated  with  the  VA  and  safety  certification 
applications submitted to ERA for the period June 2019 - 2022 are estimated at EUR 21.3 
million.  

NSAs  also  pointed  to  some  negative  impacts  related  to  the  new  authorisation  and 
certification process in place, however, no evidence of actual negative costs impacts was 
found. When it comes to regulatory costs for NSAs, the expected cost reductions did not 
materialise essentially due to the increased number of vehicle authorisations requested. 

The stakeholders also mentioned the increased cost of sharing data across platforms and 
potentially higher data errors due to a lack of integration of the different EU rail registers.  

It  appears  that  there  were  no  direct  cost  savings  for  the  railway  sector  from  the  new 
authorisation and certification process under the dual system – or at least for most of the 

63 

 
railway businesses. Considering what has already been delivered, ERA has made good use 
of the resources made available – which were less than initially planned. It has delivered 
in all the relevant areas and objectives, even though to different extents, i.e., authorisation 
tasks were prioritised over policy tasks. The effects and impacts achieved were delivered 
at a moderate cost.  

Coherence 

The  Agency’s  mandate  is  largely  consistent  with  the  broader  legislation  and  specific 
initiatives  aiming  at  creating  the  SERA.  ERA’s  objective  of  ensuring  high  levels  of 
interoperability  across  the  EU  railway  system  is  fully  consistent  with  the  liberalisation 
process and relevant infrastructure development initiatives, being a key enabler of these 
policies.  

There is overall coherence  between the Agency’s mandate  and the EU policy priorities 
reflected in the EU Green Deal and the Sustainable and Smart Mobility Strategy (SSMS) 
– but also with several UN SDGs.  

When  looking  at  coherence  with  the  EU  Green  Deal,  ERA’s  objectives  indirectly 
contribute to the achievement of two Green Deal objectives, to increase the EU’s climate 
ambition for 2030 and 2050 (including a target of a 90% reduction in transport’s emissions 
by 2050 relative to 1990) and to accelerate the shift to sustainable and smart mobility.  

There  are  also  clear  and  direct  links  with  SSMS  priorities.  For  example,  the  general 
objective of ERA is aligned with both Flagship 3 and Flagship 8 initiatives, which include 
reference to SERA and support its acceleration.  

ERA’s objective to ensure a high level of rail safety and interoperability in the EU and 
promote  safety  culture  is  directly  linked  with  the  SDG  11  (Sustainable  Cities  and 
Communities) which calls for the provision of safe, affordable, accessible and sustainable 
transport systems by 2030, in particular by expanding public transport. There is a further 
indirect alignment with SDG 9 Industry, Innovation and Infrastructure, target 9.1 on the 
basis that ERA’s role facilitating the harmonised deployment of ERTMS and interoperable 
railway  systems  is  supportive  of  developing  ‘quality,  reliable,  sustainable  and  resilient 
infrastructure,  including  regional  and  cross-border  infrastructure’.  Indirect  positive 
linkages  were  also  identified  between  SDG  11  and  ERA’s  objectives  to  contribute  to 
developing  SERA  and  eliminate  operating  barriers,  and  between  SDG  9  (Industry, 
Innovation and Infrastructure) which calls for the enhancement of scientific research and 
greater  encouragement  of  innovation  with  associated  funding  and  ERA  objectives  to 
ensure  a  high  level  of  rail  safety  and  interoperability  and  reduce  time  to  market.  The 
promotion of innovation in the rail sector can be expected to indirectly contribute to the 
broader objective to accelerate the shift to sustainable and smart mobility. 

The ERA objective of eliminating operating barriers, facilitate the entrance of new railway 
undertakings and suppliers of rail equipment into markets is indirectly aligned with SDG 
16, related to the promotion of peace, justice and strong institutions, in particular target 
16.6  that  requires  development  of  effective  accountable  and  transparent  institutions. 
Through  the  development  of  the  OSS  to  help  eliminate  administrative  barriers  and  the 
removal  of  national  barriers  ERA  contributed  to  making  the  relevant  procedures 
transparent to stakeholders. ERA also demonstrates transparent reporting as to its activities 

64 

 
and progress against targets through a Communications and Dissemination Plan. There is 
a further consistency, albeit an indirect one, with SDG 11 on the basis that an opening of 
the rail market and associated expansion of rail services should also positively contribute 
to the provision of safe, affordable, accessible and sustainable transport systems by 2030. 

No significant inconsistencies were identified in the legal framework and operation of ERA 
besides the important trade-offs in the delivery of the authority and policy tasks due to the 
resource constraints faced by the Agency. NSAs and railway sector representatives also 
highlighted the resources challenges faced by the Agency due to budget constraints and 
establishment cap. Railway sector representatives indicated that this limits ERA’s ability 
to  deliver  the  ambitious  objectives  set  by  the  European  Commission,  while  one  NSA 
commented  that  ERA  is  subcontracting  out  its  core  business  to  private  companies. 
Consequently, ERA had to reallocate resources from the policy to the authority tasks to 
ensure the processing of applications within the timetable set by the ERA Regulation.  

This reallocation of resources has had a direct impact on the capacity of the Agency to 
deliver on other objectives and roles, including in relation to the monitoring of NSAs and 
the screening of national rules. More concretely, the NSAs monitoring conducted by ERA 
in the first three-year cycle (2019-2021) focused only on some priority aspects considered 
to be essential to get assurance on the safety level achieved by Member States, i.e., staff 
competence  management  within  NSAs,  and  NSA  supervision  activities,  including 
supervision  strategy  and  planning,  integration  of  a  risk-based  approach  for  prioritising 
supervision activities, and delivery of supervision of the safety performance of relevant 
actors of the railway system. This was a decision taken by the ERA Management Board 
for a “targeted scope of audits” and it was justified by the significant resource constraints 
faced by the Agency and the objective that had been set in 2017 to complete an audit of all 
EU NSAs within the three-year cycle.  

Nonetheless,  these  trade-offs  also  had  some  positive  impact  in  the  form  of  sharing  of 
learnings  between  different  tasks,  enabling  experience  gained  from  authorisation  to 
support policy development and thus seeking to avoid any contradictions between the two 
different functions.   

Other  contradictions  include  some  NSAs  and  national  authorities  pointing  to  possible 
conflicts of interest between ERA’s equal footing to all NSAs as an authorisation authority 
and its parallel task of monitoring the NSAs, including assessing its own cooperation with 
NSAs. However, so far there is no evidence suggesting any bias in the monitoring of the 
NSAs by the Agency. Further, the 4th Railway Package introduces NoBos monitoring but 
not Assessment Bodies (AsBos) monitoring despite these being juridically equal. 

Reflecting the relatively limited experience so far, more harmonisation of the approaches 
of different Member States and technical suppliers in implementing the Regulation would 
have been beneficial, as  well as a more coherent  approach for trackside and on-vehicle 
ERTMS equipment giving more consideration of the impacts on the complete value chain. 

Overall, the ERA mandate appears to be largely coherent with the broader legislation and 
specific  initiatives  aiming  at  creating  SERA.  No  internal  coherence  issues  have  been 
identified.  

65 

 
4.2 HOW DID THE INTERVENTION MAKE A DIFFERENCE AND TO WHOM? 

EU added value 

The  enhanced  role  of  ERA  has  brought  several  benefits  that  would  not  be  possible  to 
achieve on the basis of national action only. The main areas where benefits of intervention 
at EU level have been identified include: 

•  Vehicle authorisation and safety certification processes. Due to action at EU level, 
harmonised  and  standardised  procedures  have  been  established  for  both  these 
processes, with the aim of reducing the costs for those procedures or at least making 
them more efficient at EU level. To this end, a common IT tool in the form of the One-
stop shop application was rolled out. 

Among the 13 NSAs that expressed their views on this, 7 indicated that Member States 
alone  could  address  the  long  and  costly  certification  and  authorisation  procedures 
either completely or to a significant extent. In comparison, only 3 out of 17 national 
authorities felt this was the case indicating they could to some extent and a further 5 
indicating to a limited extent or not at all. Only 1 out of 9 railway sector representatives 
considered that Member States alone could address the long and costly certification 
and authorisation procedures, with 6 stating they could in fact only address this to a 
limited extent. 

Stakeholder  views  were  mixed  specifically  with  regards  to  reducing  costs  and  the 
duration of the VA process. Among the NSAs that responded to the survey, 5 out of 13 
stated that action at Member State level could deliver on reducing costs and duration 
of  the  VA  process  to  a  significant  extent,  whilst  another  3  stated  only  to  a  limited 
extent. 4 out of 17 national authorities that replied also stated to a significant extent, 
however another 6 indicated only  to  a limited extent or not  at  all.  Of the 9 railway 
sector representatives, 5 stated that Member State action could only deliver reduced 
costs and duration to a limited extent, compared to just 1 stating completely.  

From those in favour of EU action, the French NSA stated that the Agency and EU 
action brings added value on new tasks related to the 4th Railway Package, including 
reduced  costs  or  reduced  delays  for  vehicle  authorisation  processes  for  railway 
undertakings operating in more than one Member State. The Polish NSA added that it 
would be hard to envisage joint authorisation procedures without the existence of EU 
level action. 

In comparison, the Luxembourgish NSA stated that this can still be done by Member 
States  quite  easily,  but  the  process  is  most  likely  quicker  with  the  Agency’s 
involvement. The Portuguese national authority pointed out that in some cases, costs 
and duration of the VA process could be lower/shorter than it is now when considering 
the authorisation case of extension of the area of use – however this is area specific e.g. 
Iberian  Peninsula.  In  view  of  the  German  NSA,  the  new  involvement  of  ERA  has 
helped with the multi-country aspect but has also brought higher costs than what could 
have been achieved at Member State level only. Finally, the representative of European 
Rail Infrastructure Managers (EIM) stated that in the short-term costs may increase but 
they should reduce in the long run. 

66 

 
Similarly to the VA process, stakeholder views were mixed with regards to reducing 
costs and the duration of the safety certification process. 4 out of 13 NSA respondents 
indicated that action at Member State level could deliver on this to a significant extent, 
whereas another 3 stated only to a limited extent or not at all. For national authorities, 
3 out  of 17 indicated Member State level  action alone could  deliver to  a significant 
extent, whilst another 5 highlighted to a limited extent or not at all. Finally, 5 out of 9 
railway sector representatives stated only to a limited extent. 

The French NSA added that the Agency and EU action brings added value on new tasks 
related to the 4th Railway Package, including reduced costs or reduced delays for SSC 
processes  for  railway  undertakings  operating  in  more  than  one  Member  State.  The 
Luxembourgish NSA added that this can be done by Member States quite easily, but 
the process is quicker with the Agency involvement. The Polish NSA commented that 
it would be hard to envisage joint certification procedures without action at EU level.  

It has to be noted that the answers from NSAs and national authorities were potentially 
focusing on the costs associated with single country applications, hence not considering 
the benefits for multi-country applications.  

Finally, the railway sector representative EIM stated that in the short-term costs may 
increase due to the EU level action, but they should decrease in the long run. 

Even though stakeholders input suggests that the expected cost savings from the EU 
level action and the Agency central role have not been as evident to this point with the 
majority of applicants indicating actual cost increases, this suggests that the reported 
increase in the costs experienced to this point does not mean that there should not be 
benefits  arising  from  the  introduction  of  multi-country  authorisations  and  safety 
certification and the more harmonised and centralised approach followed under ERA 
(as initially expected). Nor does it mean that individual railway business may have not 
already experienced these specific benefits. However, to this point, such benefits have 
not arisen at an aggregate level due to various limitations in the initial stages of the 
implementation  of  process  and  the  lack  of  familiarity  of  applicants  with  the  new 
processes introduced by the 4th Railway Package.  

•  Assessment and where necessary, removal of national rules. Action at EU level has 
ensured  that  there  is  a  systematic  process  to  deliver  consistent  assessments  of 
compatibility of national rules with the relevant TSIs and CSMs. 

Most  respondents  to  the  survey  supported  EU  level  action  when  looking  at  the 
elimination of redundant national rules. 7 out of 13 NSA respondents stated action at 
Member State level could only deliver this to a limited extent or not at all (compared 
to  just  2  who  indicated  to  a  significant  extent),  along  with  11  out  of  17  national 
authorities and 7 out of 9 railway sector representatives. The French NSA added that 
EU  level  activities  that  decrease  barriers  such  as  reducing  national  rules  bring 
significant added value.  

•  Monitoring  of  NSAs  and  NoBos:  the  structured,  harmonised  and  systematic 
monitoring process identifies deficiencies and areas for improvement in operation of 
these bodies and triggers appropriate reaction to ensure a minimum level of capacity. 
This effect would not be possible - at least to the same extent and for all NSAs - based 

67 

 
on national action only. Further, mutual confidence between NSAs, NoBos and ERA 
is  vital  for  the  monitoring  process  to  work  and  the  leading  role  of  ERA  in  the 
monitoring  process  facilitates  the  sharing  of  experience  between  NSAs  and  NoBos. 
The majority of stakeholders  that  expressed their views  were in favour of EU level 
action  with  regards  to  ensuring  a  coordinated  approach  to  monitoring  of 
performance  and  decision-making  of  NSAs  and  NoBos.  Out  of  the  13  NSA 
respondents, 9 stated Member State action alone could only deliver to a limited extent 
or not at all. 12 out of 17 national authorities agreed, having stated only to a limited 
extent or not at all, along with 7 out of 9 railway sector representatives. The Portuguese 
national authority added that the NSA monitoring process is an area which would not 
be possible to deliver without the presence of the roles and responsibilities assumed by 
ERA under the 4th Railway Package. 

•  Harmonised  deployment  of  ERTMS  trackside  equipment.  ERA,  being  the  system 
authority for ERTMS, has the best competence to ensure harmonised deployment of 
the system thanks to its ERTMS trackside approval process.  

Among  the  13  NSAs  respondents  to  the  survey,  8  considered  Member  State  action 
alone  could  only  ensure  consistent  development  of  telematics  and  ERTMS 
deployment, harmonised ERTMS solutions to a limited extent or not at all, compared 
to  only  2  that  indicated  it  could  completely  or  to  a  significant  extent.  National 
authorities exhibited similar views, with 12 out of 17 having stated to a limited extent 
or  not  at  all  and  only  1  to  a  significant  extent.  A  large  majority  of  railway  sector 
representatives (8 out of 9) also indicated Member State action alone could only deliver 
this to a limited extent or not at all.  

The  Latvian  NSA  added  that  the  role  of  the  Agency  and  EU  level  action  is  very 
important for ERTMS projects as they are at the EU level. The Portuguese national 
authority  also  stated  that  the  consistent  development  of  telematics  and  ERTMS 
deployment  is  an  area  which  will  not  benefit  without  the  presence  of  the  roles  and 
responsibilities assumed by ERA under the 4th Railway Package. 

In all above areas, the action at EU level was also more impactful in terms of organising 
and coordinating the necessary dialogue and cooperation among the relevant actors in the 
sector across the EU (e.g. NSAs and NoBos cooperation networks) and the access to the 
relevant technical and EU wide expertise needed to support the development of TSI and 
CSMs.  

Further, the problems identified in the 2013 Impact Assessment could only be solved to a 
limited extent if addressed only at Member States level. The extent would vary depending 
on the specific problem under consideration. In the case of authorisation and certification 
processes, Member States could improve them to a limited extent given the ongoing work 
and  cooperation  agreements  between  neighbouring  NSAs  covering  also  multi-country 
authorisations. However, their actions would not be as comprehensive and harmonised as 
in the case of ERA’s involvement and would not ensure the same level of benefits across 
the EU. 

Furthermore,  there  would  be  neither  an  incentive  nor  obligation  for  Member  States  to 
remove national rules and reduce the overall fragmented legal framework across the EU. 
As a result, individual action by Member States alone would not be sufficient to remove 

68 

 
the barriers for new market entrants and the cooperation and support for integration would 
be limited.  

Member  States  would  most  likely  be  able  to  address  certain  aspects  of  safety  in  the 
respective national network, but to a lesser extent interoperability across the EU, besides 
perhaps  among  those  with  extensive  rail  or  territorial  linkages.  At  the  same  time  their 
intervention would lack an EU-wide perspective in developing technical specification and 
– especially for the Member States with reduced resources – deprive them of the capacity 
and expertise brought by ERA. 

National funding could serve, to some extent, as an important driver for innovation and 
modernisation of the railway sector. However, the results would be fragmented and not 
deliver the enhanced geographical and market scope for new technologies that would result 
from action at the EU level. Moreover, the result from national funding would not ensure 
that new technologies are based on commonly applied technical specifications across the 
EU. 

In  conclusion,  action  at  EU  level  has  brought  benefits  in  comparison  to  action  only  at 
national level. EU level action has led to the establishment of harmonised and standardised 
procedures for vehicle authorisation and safety certification and the presence of a common 
IT system and data registers that support the application process and the more effective 
monitoring of the implementation of the 4th Railway Package. Further, it has also ensured 
a harmonised, systematic and structured approach in the screening and removal of national 
rules as well as to the monitoring of NSAs and NoBos. 

National  action  would  most  likely  be  able  to  address  certain  aspects  of  safety  in  the 
respective national networks, however it would not be expected to have the same impact 
in  terms  of  promoting  interoperability  across  the  EU  (besides  perhaps  among  those 
Member States with extensive rail/ territorial linkages).  

4.3 IS THE INTERVENTION STILL RELEVANT? 

Relevance  

The consideration of needs identified in the 2013 Impact Assessment and at the time of the 
adoption of the 4th Railway Package (i.e. lengthy and costly authorisation and certification 
procedures,  discrimination  against  new  market  entrants,  a  lack  of  modernisation  and 
innovation  in  the  rail  sector  and  the  need  to  ensure  safe  and  interoperable  railway 
operations) and the assessment of the objectives of the intervention has revealed that the 
problems are still valid today. 

Even  though  the  efforts  to  address  these  needs  have  resulted  in  improvements  in  some 
areas (i.e., in safety performance and some progress in ERTMS deployment), the original 
objectives of the Agency – and the need for the respective actions - continue to be relevant.  
This finding is also supported by stakeholders, with the majority agreeing that there is still 
a need for action to address the needs initially identified. For example, 14 out of the 16 
national authorities that replied to the survey, 8 out of 9 railway sector representatives and 
136 out of 206 railway businesses indicated that the objective to reduce the length and cost 
of procedures remains relevant to the current problems and needs of the railway sector. 

69 

 
Only 8 NSAs (out of 14) expressed disagreement with this view although most agreed that 
there were still cost issues associated with the certification and authorisation procedures. 

Concerning the key elements of the 4th Railway Package (i.e. the dual system, the OSS and 
the harmonised implementation of the ERTMS), the evaluation showed that they meet the 
needs of the EU railway sector, even if they have not yet fully achieved their objective and 
delivered the expected benefits.  

The  introduction  of  the  dual  system  was  aimed  to  promote  a  harmonised  approach  to 
processing  the  applications  for  VAs  and  SSCs  while  also  providing  flexibility  for 
applicants  to  use  the  NSAs  in  the  case  of  single  country  applications.  Following  the 
implementation of the dual system, the volume of work of the Agency linked to the new 
authority  tasks  increased  over  time.  An  important  share  of  this  increased  volume  was 
related to multi-country applications with an area of use in multiple Member States. This 
has supported in particular those applicants planning to run cross-border operations.  

There  was  significant  level  of  support  across  all  stakeholder  groups  concerning  the 
relevance  of  the  dual  system  of  the  4th  Railway  Package.  The  stakeholder  consultation 
indicated that the dual system is considered appropriate with recognition of the benefits of 
its  introduction.  First,  ERA  can  coordinate  NSAs  across  different  Member  States  and 
overrule NSAs if there are discrepancies in the way issues are handled. When combined 
with the OSS, it is a simpler system for those wanting to operate in multiple countries. 
Second, no stakeholders considered that the NSAs should not be involved in the process 
of authorisation/certification, i.e., that this should only be a responsibility of the Agency. 
One NSA noted that language could be a particular challenge for ERA in the future, given 
that  applications  for  authorisation/certification  can  be  submitted  in  any  of  the  EU 
languages, and ERA staff still needs to be able to read the documents even if NSAs are 
involved in authorisations/certifications. 

Overall, the stakeholder consultation revealed that the dual system, although it is not yet 
operating  optimally,  does  work  better  with  both  ERA  and  NSAs  involved.  Among  the 
respondents to the targeted consultation, 133 out  of 221 respondents agreed or strongly 
agreed that the operation of the dual system with the enhanced role for the Agency and 
shared responsibility between ERA and the NSAs meets the need of the sector (including 
7  out  of  13  NSAs,  17  out  of  17  national  authorities,  five  out  of  nine  railway  sector 
representatives and 107 out of 185 railway businesses). This setup better meets the sector’s 
needs while aligning with the objectives of the 4th Railway Package. 

The  development  and  operation  of  OSS  was  aimed  at  streamlining  and  managing 
applications  in  a  fair  and  transparent  way.  It  should  allow  users  to  track  progress  and 
interact with both ERA and NSAs (for single Member States applications) from the pre-
engagement stage through to an authorisation or certification being issued. It has been in 
operation since June 2019 and, despite the current limitations in terms of the functionalities 
and the interfaces with ERA registers and NSAs own systems, the input amongst users has 
in general been positive. There was a high-level agreement across all stakeholder groups 
that OSS meets the needs of the railway sector (12 out of 14 NSAs, 13 out of 16 national 
authorities,  eight  out  of  nine  railway  sector  representatives  and  153  out  of  203  railway 
businesses agreed or strongly agreed; in total 186 out of 242 respondents to the survey). 
Further  to  this,  the  existence  of  a  programme  of  continuous  improvement  of  the  OSS 

70 

 
suggests that there is capacity and plan to ensure that it meets the changing needs of the 
authorisation and certification process and of the sector more broadly. 

More  effective  and  faster  adoption  of  technological  developments  in  the  areas  of 
automation,  digitalisation,  adoption  of  greener/sustainable  solutions  and  new  mobility 
solutions  will  be  key  in  the  modernisation  of  the  EU  railway  sector,  delivering  on 
decarbonisation  targets  and  strengthening  its  competitiveness.  All  this  points  to  the 
ongoing and even enhanced need to increase the pace of modernisation and innovation in 
the railway sector and to reduce time to market. This is also a conclusion supported by 
most stakeholders that contributed to the targeted consultation. Nine out of 14 NSAs, 13 
out of 15 national authorities, five of out of nine railway sector representatives and 157 out 
of 199 railway businesses (total of 184 out of 237 respondents) agreed or strongly agreed 
that  modernisation  and  innovation  in  the  railway  sector  are  happening  at  a  slow  pace. 
Simultaneously,  stakeholders  pointed  out  that  that  slow  and  costly  procedures  -  with 
specific reference made to the lengthy process for including innovations in TSIs and the 
need for extensive, detailed checks - are also a contributing factor to slow modernisation 
and innovation.  

At the same time though, there was some discord about the relevance of this objective for 
the Agency. 10 out of the 15 national authorities that expressed their views agreed, as did 
railway businesses (114 out of 192), but a significant share of NSAs (5 out of 13) disagreed 
(compared  to  4  out  of  13  who  agreed)  while  the  most  common  response  from  railway 
sector representatives was neutral (5 out of 9). The main point made in that respect was 
that  reducing  time  to  market  of  innovation  should  not  be  considered  a  core  task  and 
objective of the Agency. 

According to targeted survey, 8 out of 10 NSAs, 11 out of 16 national authorities, 6 out of 
8 railway sector representatives and 123 out of 172 railway businesses (in total 148 out of 
206  respondents),  agreed  or  strongly  agreed  that  the  harmonised  implementation  of 
ERTMS meets the needs of the railway sector, as it is fundamental to the achievement of 
SERA.  

5.  WHAT ARE THE CONCLUSIONS AND LESSONS LEARNED? 

5.1 CONCLUSIONS  

The Commission has carried out an evaluation covering the scope required by Article 82(1) 
and (2) of ERA Regulation, i.e. the role of the Agency, its impact, effectiveness, efficiency, 
coherence,  EU  added  value,  relevance,  as  well  as  the  implementation  of  the  ERA 
Regulation  with  a  particular  focus  on  the  functioning  of  dual  system  for  vehicle 
the  harmonised 
authorisation  and  safety  certification, 
implementation of ERTMS in the Union.  

the  one-stop  shop  and 

However, it should be noted that the implementation of the 4th Railway Package had not 
reached its full potential during the evaluation period. The learning curve of stakeholders 
to adjust to the changes of the 4th Railway package had not yet been completed during the 
evaluation  period,  meaning  that  cost  and  time  saving  effects  did  not  materialise  yet. 
Further,  despite  extensive  and  thorough  consultation  activities,  there  were  insufficient 

71 

 
quantitative data on costs of authorisation and certification for applicants as well as on time 
and costs to NSAs for processing applications. 

Despite these limitations, the evaluation provides a comprehensive snapshot of the existing 
information and a consistent analysis of the aspects required by Article 82(1) and (2) of 
ERA Regulation. 

The evaluation identified a series of issues as problematic:  

•  The operation of the new system has not yet delivered, for the majority of applicants, 
the administrative burden and broader cost savings expected at the time of the adoption 
of the 4th Railway Package. There are multiple drivers for this result: 

o  At the initial stages of the implementation of the process, there was a limited 
experience  and  familiarity  with  the  new  process  and  the  OSS  of  many 
applicants.  

o  The  limited  capacity  and  cooperation  by  some  NSAs  in  the  processing  of 
applications, as part of the dual system. The limited level of use by a large share 
of  applicants  of  multi-country  applications  –  with  the  exception  of  wagon 
authorisations – and the preference for multiple single country application has 
also prevented further cost savings from materialising.  

o  Comparatively  higher  hourly  fees  charged  by  the  Agency  in  comparison  to 
most  national  authorities.  This  is  combined  with  what  appears  to  be  a  more 
thorough and more demanding approach adopted by the Agency for checking 
relevant documentation together with some practical limitation of the OSS in 
terms of the handling of documentation.  

o  Significant  delays  were  accumulated  in  the  development  of  some  registers. 
RINF and SRD did not fully deliver the expected outcomes in terms of both 
facilitating  route  compatibility  checks  and  providing  clarity  on  applicable 
national rules. Further, similar data is required by different EU rail registers due 
to the lack of integration between them and with the OSS. This leads to further 
complexity,  increased  cost  of  sharing  data  across  platforms  and  potentially 
higher data errors. 

•  Since  the  adoption  of  the  4th  Railway  Package,  ERA  has  faced  the  challenge  of  an 
establishment plan cap and limits to the capacity for recruiting of additional resources, 
together with an increasing demand for authority related tasks alongside an ongoing 
and increasing demand for the policy related tasks. The Agency largely mobilized the 
necessary human and financial resources for delivering its new authority tasks, but this 
was largely the result of ERA’s prioritisation of the delivery of the new authority tasks 
over  the  policy  related  tasks,  with  a  corresponding  reallocation  of  resources.  This 
reallocation delayed the delivery or reduced the scope of important policy related tasks 
(including  development  of  TSI,  cleaning  of  national  rules,  NSAs  and  NoBos 
towards 
monitoring)  with 
harmonisation across the EU and supporting interoperability. Indirectly, this also has 
had  negative  impacts  on  the  achievement  of  the  Agency’s  objective  of  reducing 
authorisation and certification time and costs since their fast delivery depends on the 
high level of harmonisation on the basis of TSIs (i.e. absence of multiple national rules 

the  contribution  of 

implications  on 

the  Agency 

72 

 
to assess compliance with) and the relevant capacity of actors involved in the context 
of the dual system – including NSAs and NoBos.  

•  With regard to the removal of obsolete national rules, there have been significant delays 
in the process in relation to the initial deadline of November 2018. The stakeholders 
see the main benefits of the process to be the actual reduction in the number of national 
rules, the stimulus  given by the ERA to  Member States in  terms  of questioning  the 
relevance of their national rules, as well as the guidance provided by ERA, which helps 
to  form  a  common  understanding  of  the  remaining  areas  where  national  standards 
remain relevant and how harmonized EU legislation should relate to these remaining 
standards. At the same time there is a clear agreement among all stakeholder groups 
that the Agency has insufficient resources to deliver on the screening and removal of 
national rules. 

•  The Agency monitoring activities have been partly delivered. The findings from the 
first and second NSA audit cycle highlighted a poor performance of some NSAs, which 
results  in  weak  oversight  of  the  railway  system  in  those  Member  States,  creating 
potential gaps which could lead to significant non-conformities being left unnoticed 
for  years.  Without  well-functioning  NSAs  carrying  out  their  role  of  oversight,  the 
effectiveness of the SSC system might be compromised. The NSA monitoring process 
is not adequate to identify such wider potential issues due to its limited scope which 
does not cover the performance of other stakeholders having an important safety role 
like railway undertakings, infrastructure managers, NIBs or Member States authorities.  

•  ERA has completed the first three-year full monitoring cycle for NoBos (2019-2021) 
over the course of which it issued in total 14 audit/inspection reports. Therefore, in this 
first cycle, ERA audited only 23% of the total number of NoBos under its mandate. 
For the cycle 2022-2024 ERA issued 10 audit/inspection reports in 2022 and another 
11  in  2023.  Therefore,  auditing  all  68  NoBos  in  the  period  2022-2024  was  not  be 
achieved, which reflects the difficulties in securing adequate resources for this task. 

•  There is a lack of a comprehensive assessment of the implementation of rail safety and 
interoperability legislation, which is supported by national action plans and capacity-
building  initiatives  provided  by  ERA,  As  a  result,  there  are  variations  in  NSA 
performance and safety levels across Member States.   

•  Although the Agency is empowered under Article 35 of ERA Regulation to perform 
complex  assessments  of  practical  implementation  of  rail  safety  and  interoperability 
legislation which could cover all relevant actors, this process was designed as an ad 
hoc  task  performed  on  a  specific  request  of  the  Commission  and  not  as  a  regular 
monitoring process. As a result, the current budgetary envelope of the Agency does not 
include the necessary resources to perform such complex assessments at Member State 
level on a regular basis. 

Summary of the conclusions per evaluation criterion  

Effectiveness. ERA had a positive contribution in all of the areas where it was expected to 
play a role in the context of the 4th Railway Package, and it has also had a positive role 

73 

 
 
towards the development of the SERA, even though the level of contribution has not been 
in all areas at the level expected.  

Considering its new authority role, ERA has successfully established, without delays or 
major disruptions, the necessary procedures and mechanisms – including the OSS platform 
– to support the issuing of authorisations for placing railway vehicles and vehicle types in 
the  EU  market,  issuing  of  SSCs  for  railway  undertakings  and  the  approval  of  ERTMS 
systems.  

However,  the  operation  of  the  new  system  has  not  yet  reduced,  for  the  majority  of 
applicants,  the  administrative  burden  and  not  yet  delivered  the  broader  cost  savings 
expected at the time of the adoption of the 4th Railway Package.  

It  appears  that  there  were  no  direct  cost  savings  for  the  railway  sector  from  the  new 
authorisation and certification process under the dual system – or at least for most of the 
railway businesses.  This means  that the net  benefits of the intervention expected in  the 
2013  Impact  Assessment  have  not  yet  materialised.  However,  any  such  assessment  is 
premature since an important driver of the additional costs reported can be linked to the 
limited experience with the implementation of the dual system by many applicants at the 
time of the survey. 

ERA  made  good  progress  in  terms  of  the  development  of  the  relevant  registers  and 
databases that can - among others - facilitate the submission and processing of applications, 
in  line  with  the  expected  outcomes  of  the  4th  Railway  Package,  although  with  some 
ongoing  limitations  in  terms  of  integration  of  registers  which  leads  to  complexity, 
increased cost of sharing data sharing and risk of data errors.  

The Agency has effectively delivered activities related to the promotion and enhancement 
of safety and interoperability across the EU, including a range of relevant technical outputs 
(e.g. TSIs, CSTs, CSMs and the use of CSIs). However, resource constraints have led to 
the  decision  to  prioritise  the  delivery  of  authority  tasks  with  a  negative  impact  on  the 
delivery  of  some  policy  tasks  including  the  monitoring  of  NSAs  and  NoBos,  and  the 
removal of obsolete national rules, both important elements in the process of eliminating 
operating  barriers,  enhancing  interoperability  and  reducing  the  time  and  costs  of  the 
authorisation process. Therefore, ERA did not meet in full the objective of screening and 
effective removal of national rules as well as of limitations concerning the monitoring of 
NSAs and NoBos.  

In June 2024, 796 national rules relevant for VA and fixed installations remained in EU 
Member States, down from 13 459 in January 2016. Removing these additional rules will 
require  considerable  effort  by  personnel  with  detailed  technical  and  operational 
knowledge, while there is in parallel a significant demand for work on TSIs, CSMs, safety 
certification and VA. At the same time, the process for screening and removing obsolete 
national rules was incomplete, limiting the effectiveness of the authorisation and safety 
certification process. 

The legal uncertainty during the process of screening and removing the obsolete, national 
rules and the creation of gaps in legislation (i.e. areas no longer covered by national rules 
but not adequately covered by EU legislation) may lead to negative impacts in terms of 
increased  workload  for  infrastructure  managers  and  railway  undertakings,  and  higher 

74 

 
administrative  costs  for  both  authorisation  entities  and  applicants.  These  cost  impacts 
could not be quantified on the basis of available evidence.  

Overall, considering the Agency’s contribution towards the effective functioning of SERA, 
the objective to perform the role of the Union authority has been largely achieved and there 
was a positive contribution towards maintaining safety levels on the basis of the relevant 
activities  delivered, 
the  monitoring  of  Member  States’  performance, 
development  of  the  recommendation  CSM  ASLP  and  the  activities  to  promote  safety 
culture. However, the CSM for occurrence reporting are not matched by an appropriate 
enabling tool and resources. There is a historical accumulation of safety-related IT tools 
based on different technologies, lacking a consistent approach.  

including 

However,  ensuring  and  enhancing  interoperability,  eliminating  operating  barriers  and 
overcoming the fragmented set of national frameworks is still work in progress. When it 
comes to the objective to support the rail sector competitiveness and innovation, the level 
of contribution to this point has been lower than expected. The alleged higher time and 
costs for authorisation and certification were identified as an obstacle in the uptake of new 
technologies. At the time of the evaluation, the limited familiarity with the new process of 
authorisation  and  safety  certification  contributed  to  higher  administrative  burden  and 
longer processing times, indicating that the dual system has not yet delivered the intended 
efficiency gains. 

Finally, considering the role of ERA in the Western Balkans, its activities funded by the 
IPA programme are  considered by the local  NSAs and the TCT to  have had  a positive 
contribution in supporting the implementation of the TCT Rail Action Plan that is intended 
to  align  the  Western  Balkan’s  railway  system  with  that  of  the  EU.  ERA  has  positively 
contributed  to  the  international  stream  of  work  by  successfully  managing  the  IPA  and 
EUMedRail grants and supporting neighbouring countries.  

Efficiency. The delivery on the Agency objectives presented under “effectiveness” took 
place on the basis of a reduced level of resources available and used by ERA. The resources 
made available for the implementation of the 4th Railway Package were significantly less 
than expected in the 2013 Impact Assessment74.  

In  terms  of  internal  efficiency  of  ERA’s  operation  and  human  resources,  the  gradual 
introduction, during the evaluation period, of internal processes and management systems 
have had a positive contribution. However, there is still scope for further efficiency gains 
in areas identified by the Agency’s own Strengthening Plan adopted in 2022.  

The analysis of the Agency HR procedures points to the positive role of a more flexible 
non-hierarchical  matrix-type  structure  facilitating  the  reallocation  of  staff  to  authority 
tasks, while the recruitment of new staff has improved over time ensuring a share of filled 
positions in comparison to the establishment plan above 90% since 2019. However, the 
use of the Pool of Experts tools has delivered much less than expected in terms of access 

74 The actual increase of human resources for ERA was 19 FTEs in the five-year period 2016-2021 in comparison to the 
55 additional FTE expected in the 2013 Impact Assessment. The total expenditure has increased from EUR 27 million 
in 2016 to EUR 29.7 million in 2021 (10% increase). This is considerably lower than the expected 33% increase of the 
ERA budget in the 2013 Impact Assessment. 

75 

 
 
to  resources  to  support  the  delivery  of  authority  tasks  (7-10%  of  the  total  workload  in 
comparison to an expectation of up to 25%). 

There are still areas where efficiency improvements are possible and could help achieve 
the same results with less resources, as identified in the Agency’s own Strengthening Plan, 
although there is no indication of significant inefficiencies. This mainly concerns the share 
of resources allocated to administrative tasks/functions but also the need for more effective 
use of ICT and resource management tools.  

The Management Board had a positive role along with external supervisory mechanisms 
(European  Commission  including  its  Internal  Audit  Service,  and  European  Court  of 
Auditors). A potential internal inefficiency was identified in the duplication of some parts 
of work between the Management Board and the Executive Board. 

Considering the dual seat Valenciennes – Lille, there is no evidence of any significant cost 
implications and based on the recent reduction to the rent, there is limited scope for further 
cost cuts.  

Relevance. The key problems/needs identified in the 2013 Impact Assessment and at the 
time of adoption of the 4th Railway Package are all still valid today. The efforts to address 
these needs - including in the context of the implementation of the 4th Railway Package - 
have  resulted  in  some  improvements  since  2016.  However,  further  effort  is  needed  to 
deliver the 4th Railway Package and fully meet its objectives. 

Overall, ERA’s objective to reduce time to market of innovation is relevant to the identified 
and ongoing  need to  enhance the pace of innovation  in  the sector. As an EU authority, 
ERA’s role in this area is expected to come both through its direct role on the time and 
costs of the authorisation and certification process (and the impact on the time to market 
for innovation), through its expected role in facilitating, coordinating the process of the 
development  of  harmonised  technical  specifications  and  its  broader  role  as  technical 
advisor. Furthermore, it can come also through its mandated role (Article 40 in the ERA 
Regulation) in identifying related research needs and promoting research and innovation 
activity  (including  through  its  involvement  in  the  Joint  Undertaking)  and  ensuring  that 
these  are  consistent  with  the  policy  priorities,  the  development  of  SERA  and  ensuring 
interoperability and safety.  

Coherence. The ERA mandate appears to be largely consistent with the broader legislation 
and  specific  initiatives  aiming  at  creating  SERA.  In  particular,  the  ERA  objective  of 
ensuring high levels of interoperability across the EU rail infrastructure and equipment is 
fully  consistent  with  the  liberalisation  process  and  relevant  infrastructure  development 
initiatives, being a key enabler of these policies.  

The Agency’s mandate appears also to be in line with the EU policy priorities, as these are 
reflected in the EU Green Deal and the SSMS75, and also with the relevant UN SDGs. No 
internal coherence issue was identified between the provisions of the ERA Regulation.  

EU added value. Action at EU level has brought benefits, compared to action at national 
level alone. EU level action has led to the establishment of harmonised and standardised 
procedures for VA and safety certification and the presence of a common IT system and 

75 EUR-Lex - 52020DC0789 - EN - EUR-Lex  

76 

 
 
data registers that support the application process and the more effective monitoring of the 
implementation of the 4th Railway package. EU level action has also ensured a harmonised, 
systematic and structured approach in the screening and removal on national rules when 
assessing compatibility with the relevant TSIs. It has also ensured a systematic approach 
to the monitoring of NSAs and NoBos. 

National  action  would  most  likely  be  able  to  address  certain  aspects  of  safety  in  the 
respective  national  networks  but  not  deliver  the  same  in  terms  of  promoting 
interoperability across the EU (besides perhaps among those Member States with extensive 
rail/ territorial linkages). 

Overall,  even  though  during  the  period  covered  by  this  evaluation  not  all  results  and 
impacts of the implementation of the legal framework have taken effect and not all actors 
involved have developed the relevant experience, the findings of this evaluation show that 
more  streamlined  procedures  for  VA  and  safety  certification  would  have  increased  the 
added value and the benefits of ERA action. Moreover, a more expedite effective delivery 
of its key policy related tasks and responsibilities, with particular focus on the cleaning of 
national rules and monitoring of NSAs and NoBos, would have ensured that ERA meets 
in full the expectations of their role in the dual system.   

5.2 LESSONS LEARNED 

The evaluation highlighted several challenges in the current system:  

• 

• 

Insufficient  performance  of  some  NSAs,  which  leads  to  hardly  expecting  any 
improvement of the overall safety situation in affected Member States. Furthermore, 
the NSAs face difficulties in  finding staff with the required level of knowledge and 
competence and in the absence of external support they cannot properly cope with the 
lack of in-house expertise. 

Insufficient  monitoring  and  reporting  of  the  implementation  of  relevant  actions  in 
response to  the deficiencies identified during the  NSAs audits, especially  for NSAs 
facing greater capacity limitations and deficiencies. 

•  The  absence  of  comprehensive  monitoring,  whereby  information  from  different 
activities (e.g. SSCs, VAs, safety data, etc.) - is consistently reviewed and acted upon, 
doesn’t  allow  to  systematically  track  progress  and  integrate  feedback  to  support 
continuous improvement of safety oversight across the EU. 

•  Limited  collection  and  analysis  of  data  by  the  Agency  on  the  operation  of  the  dual 
system, including on time and costs incurred by NSAs for processing of applications. 

•  Despite  limitations  related  to  the  available  data,  the  collected  information  and 
stakeholders’ views confirm the complex and less effective VA and safety certification 
processes, particularly in the operation of the dual system, due to less efficient national 
part  of  the  process  including  unnecessary  assessments  at  national  level,  lack  of 
integration of registers between them and with the OSS, and duplication of requested 
documentation and checks to be performed.  

77 

 
•  Lack of clear deadlines for NSAs to respond to the delivery of their own assessments 
as part of single or multi-country applications processed by ERA impact on expediting 
the authorisation and certification process. 

•  Redundant national rules have a negative impact on the effectiveness of the VA and 
safety  certification  process  and  contribute  to  cross-border  bottlenecks.  Further,  the 
visibility of the accepted national rules is not sufficient to reduce uncertainty around 
applicable rules to support the authorisation and certification process.  

•  Limited  analysis  and  inconsistent  reporting  on  safety  performance  at  Member  State 

level and inconsistent application of the EU rail safety framework. 

• 

Insufficient involvement of ERA in occurrence information collection and analysis to 
support early identification of emerging safety risks.  

•  Constraints on ERA’s authority and capacity to perform policy tasks, develop and share 
knowledge and expertise as well as to fully support national actors (including NSAs 
and NoBos) in terms of capacity building.  

•  Resource  allocation  challenges  and  limitations  in  delivering  ERA’s  mandate, 
especially on the delivery of the policy tasks, due to the priority given by the Agency 
to the authority related responsibilities and indirectly on reducing time and costs for 
authorisation and certification. The Strengthening Action Plan had not yet led to full 
exploitation of efficiency gains, as evidenced by persistent administrative workloads 
and partial redeployment of staff to operational tasks. 

• 

Insufficient  scope  of  the  projects  supporting  the  implementation  of  the  TCT  Rail 
Action Plan that is intended to align the Western Balkan’s railway system with that of 
the EU, as well as insufficient ERA role and contribution towards enhancing railway 
safety and interoperability outside the EU.  

78 

 
 
 
 
 
 
 
 
 
 
 
ANNEX I:  PROCEDURAL INFORMATION 

•  General information 

The lead DG is the Directorate-General for Mobility and Transport (MOVE), Unit C4 
Rail Safety and Interoperability. 

DECIDE reference number: PLAN/2020/9063. 

•  Organisation and timing  

The evaluation was coordinated by an Interservice Steering Group (ISG). The Commission 
services participating in the ISG were the Secretariat-General, Legal Service, DG Human 
Resources  and  Security,  DG  Budget,  DG  Environment,  DG  Climate  Action,  DG  for 
Internal Market, Industry, Entrepreneurship and SMEs, and relevant units of DG Mobility 
and Transport.  

The ISG met 5 times: on 15 December 2020, 6 January 2022, 4 March 2022, 8 July 2022, 
and  on  27  June  2025.  It  was  consulted  throughout  the  different  steps  of  the  evaluation 
process, notably on the consultation documents, deliverables of the support study and on 
the draft Staff Working Document. When necessary, bilateral discussions were organised 
with the concerned services. 

•  Evidence, sources and quality  

The  evaluation  is  based  on  several  sources  of  evidence,  using  both  quantitative  and 
qualitative data. This includes: 

-  Stakeholder consultation activities (see Annex 5). 

-  Evaluation support study carried out by an external contractor (Ricardo). 

-  Commission  experience  in  implementing  the  technical  pillar  of  the  4th  Railway 

Package. 

-  Reports and information provided by ERA. 

Annex II provides an overview of the methodology used, as well as issues regarding the 
quality of the evidence gathered, through both desk and field research. 

79 

 
 
ANNEX II. METHODOLOGY AND ANALYTICAL MODELS USED 

Process 

This  evaluation  was  based  on  a  methodology  consistent  with  the  Better  Regulation 
Guidelines and Toolbox, with the support of an external study76. Following the publication 
of the evaluation roadmap77 on 1 March 2021, the Commission launched the process for 
contracting  the  external  study.  The  terms  of  reference  provided  the  scope  and  draft 
evaluation  questions  to  address  the  five  evaluation  criteria:  effectiveness,  efficiency, 
coherence, EU added value and relevance, and developing the approach proposed in the 
evaluation roadmap.  

This annex describes the methodology applied for the evaluation. 

Methodological framework 

The  external  study  further  developed  the  initial  intervention  logic,  providing  the 
foundation for building a comprehensive evaluation framework. It was used to capture the 
logic  of  the  Regulation  and  the  causal  chain  linking  objectives,  activities,  inputs  and 
expected outcomes.  

An evaluation matrix (see Annex III) was developed that sets out the following aspects 
for each evaluation question: 

-  Operational sub-questions: These break down the evaluation questions into smaller, 

measurable aspects. 

- 

Indicators:  Identify  the  measures/metrics  that  correspond  to  each  operational  sub-
question. These may be qualitative or quantitative.  

-  Evaluation  approach  and  success/judgement  criteria:  Outline  the  methodology 

used to answer evaluation questions and form the conclusions.  

-  Potential data sources: Sources of data and information used to inform the indicators. 
As  far  as  data  was  available,  information  was  triangulated  from  several  sources  for 
each  indicator  aiming  to  have  at  least  input  from  two  different  sources  for  cross-
checking. 

The evaluation matrix was reviewed several times during the study, taking into account 
Commission  inputs  as  well  as  evidence  collection  activities  (desk  research,  interview 
programme, survey responses and data requests), to reflect the identification and review of 
data sources, as well as updated evidence needs and gaps and the improved understanding 
of the mechanisms and structures leading to better targeted questions.  

Following the conclusion of the evidence collection activities (i.e., interview programme, 
targeted  survey,  OPC,  direct  data  requests,  and  desk  research)  and  the  analysis  of  the 
findings, the intervention logic was updated. Further, the evaluation matrix was expanded 
to  produce  a  final  version  of  the  matrix  integrating  with  the  updated  understanding  of 
evidence sources and gaps. This was used to inform the selection of success criteria and 
indicators used for each evaluation question.  

76 Ricardo (2023), Evaluation support study 
77 EU Agency for Railways – European Commission evaluation of the Agency’s work 

80 

 
 
Evidence collection  

Desk research was used throughout the course of the evaluation to address the following 
objectives: 

- 

- 

- 

Identify and collect qualitative and quantitative evidence to support the analysis of the 
evaluation questions. 

Identify any information gaps and propose how to manage these gaps through targeted 
consultation activities. 

Identify  and  collect  data  used  as  input  to  the  evidence  analysis,  and  for  the  other 
indicators identified in the evaluation matrix that are used to support the analysis.         

The field research has been structured within the context of a stakeholder consultation 
strategy,  which  relied  on  a  combination  of  stakeholder  engagement  tools,  including 
targeted surveys and interviews, direct data requests and an analysis of other consultation 
activities  led  by  the  Commission  (OPC).  The  approach  to  the  targeted  surveys  and 
interviews was refined following the exploratory interviews which took place during the 
inception  phase  of  the  evaluation.  More  details  on  the  stakeholders’  consultation  are 
provided in Annex V.  

The  evaluation  support  study  had  a  duration  of  14  months  (November  2021-December 
2022).  It  included  various  consultation  activities  that  took  place  between  April  and 
September 2022. The findings from these consultation activities were mostly used for the 
analytical part of this report, i.e. section 4. Further, ERA provided additional data that were 
used mainly for an extensive description of how the situation evolved between June 2019 
and June 2024 (section 3 of this report), hence going beyond the period covered by the 
evaluation support study. These additional data were also used to update, when relevant, 
the  other  sections  of  the  report.  Throughout  the  report  findings  from  the  Consolidated 
Annual Activity Reports 2017-2023 were considered, where relevant.  

Shortcomings and limitations of the analysis  
There  are  certain  limitations  that  need  to  be  taken  into  account  when  considering  the 
findings presented and the resulting conclusions, which are summarised below: 

•  The analysis took place in a period where the implementation of certain key aspects of 
the 4th Railway package was still incomplete (e.g. national rules cleaning, monitoring 
of  NSAs  and  NoBos)78,  and  the  level  of  experience  with  the  operation  of  the  dual 
system  for  authorisation  and  certification  was  relatively  limited.  This  allowed  to 
capture  possible  issues  and  limitations  of  the  implementation  of  the  system  to  this 
point.  However,  it  also  meant  that  the  comparison  with  the  expected  benefits  (as 
identified in the 2013 Impact Assessment that supported the 4th Railway Package) was 
possibly  premature  and  probably  overstates  the  weaknesses  and  limitations  of  the 
system  that  was  still  work  in  progress.  There  was  a  learning  curve  concerning  the 

78 It should be noted that these are not one-off processes that had to be completed by a given date (which has 
not  been  the  case),  but  ongoing  processes  for  the  Agency  reflecting  the  evolution  of  new  TSIs  and  the 
continuous monitoring of the NSAs and NoBos performance as part of the implementation of the dual system. 
However, the fact that the initial round of these processes has not been delivered as initially planned (before 
the  launch  of  the  dual  system)  has  played  an  important  role  in  the  level  of  achievement  of  some  of  key 
outcomes. 

81 

 
 
implementation of the various processes by ERA, NSAs and applicants and this was 
reflected in the input provided. Input related to cost impacts (and the comparison with 
the  3rd  Railway  Package)  was  influenced  by  the  limited  experience  of  some 
respondents  with  the  new  system  and  they  were  unable  to  make  a  comparison  or 
suggested that more time was needed.  

•  The evaluation support study commissioned by the Commission had a duration of 14 
months (November 2021–December 2022). It included various consultation activities 
that  took  place  between  April  and  September  2022.  The  findings  from  these 
consultation activities were mostly used for the analytical part of this report, i.e. section 
4.  Further,  ERA  provided  additional  data  that  were  used  mainly  for  an  extensive 
description of how the situation evolved between June 2019 and June 2024 (section 3 
of this report), hence going beyond the period covered by the evaluation support study. 
These additional data were also used to update, when relevant, the other sections of the 
report. Throughout the report findings from the Consolidated Annual Activity Reports 
2017-2023 were considered, where relevant. 

•  The analysis of the actual costs related to authorisation and certification was limited 
by the fact that input provided from railway sector was limited and mainly qualitative. 
It was sought through follow up interviews with survey respondents to collect more 
specific  cost  data,  however  the  response  rate  was  low.  As  a  result,  cost  estimates 
provided are uncertain.  

• 

In addition, while there were detailed data on applications processed by ERA (provided 
by ERA), the data available in terms of the time and costs for NSAs applications was 
more limited. As a result, the assessment made is mainly qualitative on the basis of 
input from applicants and NSAs.  

•  Availability  of  data  was  a  challenge  affecting  in  particularly  the  effectiveness  and 
efficiency  criteria.  Where  quantitative  data  was  available,  it  was  used  to  make 
estimations and was complemented by stakeholder opinions and positions. Information 
gathered from different sources, including input from stakeholders were compared and 
triangulated  whenever  possible.  In  the  case  when  available  data  and  literature  was 
limited,  consultation  responses  were  relied  upon  to  answer  the  evaluation  questions 
and are indicated throughout this report. 

Taking this into account, certain conclusions  – particularly in relation to the costs/costs 
savings – are tentative. These may likely change (improve) over time; further assessment 
will be necessary at a later stage.  

82 

 
Development of the evaluation points of comparison 

Two points of comparison were defined to inform the evaluation.  

Point of comparison - baseline scenario  

The baseline scenario for this evaluation is based on the assumption that the 4th Railway Package 
would not have been adopted, including both the ERA Regulation, but also Directives 2016/797 
and  2017/798.  This  is  because,  the  two  Directives  include  extensive  cross-references  to  the  ERA 
Regulation and their implementation is dependent on the ERA Regulation.  

The baseline scenario covers relevant contextual aspects, as well as aspects directly related to the role 
of the Agency in the implementation of the 4th Railway Package. It is based primarily on the review 
of the 2013 Impact Assessment study and the 2011 Evaluation of Regulation 881/2004, but also on 
input received during the interviews with stakeholders.  

For each aspect considered, the assumed evolution under the baseline scenario is presented and, where 
possible, how the relevant parameters that have been used to assess the performance of the Agency 
may have been expected to evolve in the absence of the 4th Railway Package.  

Table 7. Baseline scenario assumptions 

Key aspect covered  

Baseline scenario 
definition /assumptions 

Legal framework 

Level of demand for 
authorisation, certification 
and ERTMS approval 
activity  

Safety and Interoperability 
Directives would not be 
revised/updated (namely 
the 3rd railway package 
will remain including 
Agency Regulation 
881/2004 as amended by 
Regulation 1335/2008)  

Additional 
guidance/recommendation 
and delegated acts to be 
developed to improve 
implementation.  

Demand for certifications 
(including in terms of 
multi-country 
authorisations) to remain 
the same over time for 
given level of demand for 
rail services (IA) 

No discernible/clear 
impact of COVID on 
demand levels. 
Assumption is that it 
would be the same under 
the baseline and 4th 
Railway Package scenario. 

Demand for authorisation 
(including in terms of 
multi-country 
authorisations) to reduce 
slightly as vehicle designs 

Assumed/expected 
impact on evolution of 
relevant indicators   

Comment/ observations 
on the basis of desk/field 
research 

n/a 

Number of certifications 
(including cases covering 
multiple countries) to 
remain stable at around 
2015 levels while total 
number of authorisations 
to reduce slightly  

Expect demand for 
ERTMS trackside approval 
to increase  

Data from ERA suggest a 
three times higher number 
of applications for VAs 
(mainly linked to 
conformity to type 
applications) than expected 
during the period 2019-
2022; ERA expects this to 
stabilise over the coming 
period.  

No similar observation in 
relation to safety 
certifications or ERTMS 
trackside approval  

83 

 
 
 
Key aspect covered  

Baseline scenario 
definition /assumptions 

Assumed/expected 
impact on evolution of 
relevant indicators   

Comment/ observations 
on the basis of desk/field 
research 

Process for vehicle 
authorisations, approvals 
of ERTMS trackside 
equipment tenders and 
safety certificates 

(new ERA role)79 

Authorisation and 
certification timescales and 
costs 

become more standardised 
over time. 

Demand for ERTMS 
installation approvals to 
increase on the basis of 
increased adoption of 
relevant 
technologies/equipment  

Assume situation on the 
basis of previous (3rd) 
railway package to 
continue  

•  No  ERA  role  besides 

recommendations/ 
guidance  and 
indirect 
contribution  through  the 
review  of  national  rules 
and TSI development 
•  Approvals  of  ERTMS 
trackside 
equipment 
tenders  performed  by 
IMs;    

•  No  option  for  a  single 

multi-country 
application (in the case of 
transport  – 
passenger 
freight 
available 
for 
since 
railway 
package) 

3rd 

Information submission 
requirements and 
procedures set by 
individual NSAs with 
limited harmonisation and 
variation in approach and 
no single point of 
reference/IT tool at EU 
level (i.e. no OSS 
platform)  

Gradual/slow tidy up of 
national rules on the basis 
of previous ERA mandate 
and activities together with 
extension of TSI rules on 
the basis of ERA activities 
should contribute to 
improvements and 
decreased variation of 
authorisation processes 

see below 

Certain Member States 
(DE, FR) report ongoing 
work to reduce 
authorisation/ certification 
costs were possible (DE 
referring to the use of the 
series authorisation 
approach for vehicle of 
same type) and 
coordination and cross-
acceptance among some 
neighbouring countries  

Small reduction to the 
average duration of 
authorisation for each 
type leading to increased 
efficiencies.   

Difference between 
average authorisation 
costs and presumed 
minimum achievable 
authorisation costs to 
reduce over time 

79 Where relevant, it is mentioned whether this represents a new role for the Agency, a pre-existing role without changes 
or an area with enhanced role for the Agency.  

84 

 
 
 
Key aspect covered  

Baseline scenario 
definition /assumptions 

Assumed/expected 
impact on evolution of 
relevant indicators   

Comment/ observations 
on the basis of desk/field 
research 

No specific activity in 
terms of certification to be 
taken 

Certification time and 
costs to remain the same 
(average of 4.5 months) 

NSAs capacity and 
approach to 
implementation of 
legislation concerning 
certification/ authorisation 

Evolution of national 
rules on safety and 
interoperability 

(pre-existing but 
strengthened role in the 4th 
Railway Package) 

Assume NSA staffing 
levels to increase to a 
limited extent with only 
two Member States (IT, 
PL) indicating intention to 
increase staffing and 
others potentially to follow  

Staffing levels in some 
Member States to remain 
an obstacle in the 
processing of applications 

NSA technical expertise, 
approach to 
implementation of EU 
legislation, and acceptance 
of authorisations/ 
certification granted by 
other NSAs to continue to 
vary (depending also on 
their size) but generally 
improve on the basis of 
experience additional 
guidance and technical 
support from the Agency  

ERA monitoring of 
national rules and process 
of gradual elimination so 
that only essential rules 
remain – gradual/slow 
elimination to be expected 
(between 2020-2025 in the 
case of national safety 
rules 2018-2020 for 
national safety rules 
according to the indicative 
time plan presented in the 
2013 Impact Assessment 

RDD and Notification IT 
to operate but no IT 
system to manage national 
rules review process 
(access/classification/infor
mation on the review 
process) 

Total NSA staff numbers 
to remain similar to 2015 
levels at around 500 staff 
(2011) 

Small reduction to the 
overall time/costs for 
processing authorisation 
and certification as a 
result of learning and 
additional guidance  

Desk research pointed to 
around 14,000 national 
technical rules for VA in 
total in January 2016 and 
circa 1400 national safety 
rules (submitted by MSs 
through NOTIF-IT) 

Number of national 
technical and safety rules 
to reduce only to a limited 
extent from 2015 levels 
(circa 11,700 in total plus 
additional 800 estimates 
technical operational rules 
and rules for maintenance)  

Level of variation/ 
discrepancy of national 
rules from the TSIs to 
reduce over time on the 
basis of the Agency 
activities with some 
positive impact on 
associated authorisation 
costs but remain sizeable  

Technical support/ 
recommendations on 
railway safety and 
interoperability 
(including TSI 
development) 

(pre-existing ERA role) 

ERA role in developing 
recommendations to EC on 
the basis of the work of 
working parties (as defined 
in Regulation 881/2004) to 
continue  

Some harmonisation 
expected though the 

Work/performance on TSI 
development to remain as 
before 2015 (as reflected 
in the conclusions of the 
2011 evaluation report)  

Ongoing delivery of 
outputs and extension of 
TSI scope to have a 

85 

 
 
 
 
Key aspect covered  

Baseline scenario 
definition /assumptions 

Assumed/expected 
impact on evolution of 
relevant indicators   

Comment/ observations 
on the basis of desk/field 
research 

ongoing development and 
extension of the scope of 
TSIs reducing the need to 
assess vehicles against 
national rules  

No ERA mandate to 
monitor decision-making 
and capacity of NSAs  

Light touch role of the 
Agency on the basis of 
exchange of practices and 
peer review and the role of 
the NSA network  

positive impact in terms of 
the reduction of the 
time/effort needed for 
authorisation/certification  

Capacity and performance 
of NSAs in delivering their 
responsibilities concerning 
safety and interoperability 
(including monitoring of 
NoBos, 
interpretation/application 
of safety and 
interoperability Directive) 
to continue to vary  

ERA monitoring role but 
only in a consultative 
manner to national 
authorities with 
requirement for follow 
up/action to address 
deficiencies  

Capacity and performance 
of NoBos in terms of 
authorisation/ certification 
to continue to vary (as 
reflected in the 
conclusions of the 2011 
evaluation) 

Monitoring of national 
bodies (new ERA role) 

Monitoring of NoBos 

(existing but strengthened 
role)  

Monitoring of safety and 
interoperability 
performance 

(existing role) 

Datasets/registers  

ERA to continue reporting 
on safety and 
interoperability 
performance (as before) 
but with less access to 
information/data (that are 
expected to be provided 
via the new 
registers/datasets 
developed and managed by 
ERA  

ERA to be responsible for 
registers concerning 
authorised vehicle types, 
national rules but to 
continue to rely on the 
provision of information 
from NSAs and national 
authorities  

ERA capacity to monitor 
safety and interoperability 
performance and outputs 
and quality of technical 
support to EC and Member 
States to remain as before 
2015 (as reflected in the 
conclusions of the 2011 
evaluation)  

Despite action to address 
some of the data gaps, the 
expected to remain with 
ongoing implications on 
the capacity to monitor 
progress with 
interoperability/safety and 
the processing of 
applications.  

Level of support from 
ERA for the harmonisation 
and integration of 
candidate countries with 
SERA to remain at the 
same reduced level    

ERA to maintain capacity 
to deliver on its roles and 
responsibilities before the 
adoption of the 4th Railway 

Level of ERA support to 
candidate countries also 
driven by the IPA 
programme priorities and 
funding 

International 
cooperation and support 
of candidate countries  

Assume reduced role of 
the Agency in the absence 
of the 4th Railway Package  

ERA internal capacity/ 
resources/ management 
structures and 
procedures 

Assume no fundamental 
changes to the Agency’s 
management/HR structures 
or the role of the 
management board  

86 

 
 
 
 
 
 
 
Key aspect covered  

Baseline scenario 
definition /assumptions 

Assumed/expected 
impact on evolution of 
relevant indicators   

Comment/ observations 
on the basis of desk/field 
research 

Package with focus on 
policy related tasks  

Limitations on 
effectiveness and 
efficiency on delivering its 
role not related to 
authorisation activities to 
be partly addressed over 
time  

ERA staff numbers to 
remain at the 2016 level 
(155 FTE) with similar 
skills and capacity in the 
absence of new 
mandate/roles 

No direct involvement and 
no experience in the 
authorisation/certification 
and ERTMS approval 
process and focus on the 
policy related tasks.  

Budget and EU 
contribution to remain at 
the level similar to 2016 
with no income from 
authorisation/certification 
fees  

87 

 
 
 
Point of comparison - 4th Railway Package implementation  

to 

the  baseline  scenario, 

the  expected 
In  addition 
achievement/delivery under the preferred policy option (i.e. combined option 4+6 in the 
2013 Impact Assessment) has been used to provide the basis for assessing the performance 
of the Agency in relation to its effectiveness and efficiency.  

information  concerning 

Table 1 in section 2.2 summarises the expected performance for the different aspects of 
the  intervention  and  identifies  relevant  targets  and  benchmarks  that  have  been  used  to 
assess  the  performance  of  the  Agency  in  its  implementation  of  the  4th  Railway 
Package.  

It should be noted that the 2013 Impact Assessment focused primarily on the expected cost 
impact for the railway sector, the Agency and the NSAs, and provided quantitative (and 
monetised)  estimates  of  the  total  cost  and  cost  savings  expected  (expressed  as  present 
value). These estimates have been based on a number of assumptions, related to the level 
of authorisation/certification activity, that are not in line with the actual level of activity. 
They  are  also  based  on  cost  assumptions  concerning  the  authorisation/certification 
procedures  that  are  not  necessarily  comparable  with  the  actual  processes  and  approach 
adopted.   

Furthermore,  the  2013  Impact  Assessment  did  not  identify  quantitative  benchmarks  for 
other parts of the implementation of the 4th Railway Package and provided relatively brief 
qualitative  description  of  the  expected  impacts.  Additionally,  in  some  areas  there  is  no 
explicit  mention  of  the  expected  performance,  but  it  is  possible  to  derive  the  expected 
impact on the basis of the 2013 Impact Assessment and the text of the ERA Regulation.   

Evidence analysis  
The data collected was analysed with the aim to respond to the evaluation questions, using 
the following approach.  

•  Effectiveness (see Table 8 in Annex III) 

The primary aim of the assessment of effectiveness is to evaluate where the Agency stands 
in terms of achieving its objectives and the factors that have contributed to this progress 
(or  led  to  a  lack  of  progress  in  certain  areas).  The  assessment  was  based  on  a  detailed 
analysis of the progress made since 2016, against the ERA objectives (both specific and 
general). 

The assessment was based on the analysis of data on the development of railway safety 
and  interoperability  across  the  SERA  during  the  evaluation  period  from  EU  statistical 
sources, ERA annual safety and interoperability performance reports. The objective was 
to  indicate  the  progress  made  in  terms  of  EU  railway  safety  and  improving  SERA 
interoperability  over  the  evaluation  period.  Further,  data  from  the  Agency’s  Annual 
Activity Reports and its SPDs were analysed, regarding the delivery of the ERA activities 
that  were  expected  to  contribute  directly  or  indirectly  to  the  specific  objectives.  This 
analysis was complemented with qualitative input from stakeholders on the extent of the 
Agency’s contribution towards the objectives. 

88 

 
 
•  Efficiency (see Table 9 in Annex III) 

The objective of the analysis of the efficiency was to assess how the resources allocated to 
support the delivery of ERA’s role compare with benefits that arose from ERA’s extended 
role.  It  also  assessed  how  any  other  costs  produced  for  the  rail  system  and  other 
stakeholders compare with the said benefits.  Furthermore, the analysis examined the role 
of  the  processes  and  mechanisms  in  place  (working  methods,  organisational  aspects, 
human resources and other tools) and the impact of external drivers on the efficiency of 
the Agency’s operations and the delivery of the expected results. 

The work of the Agency was analysed to this point concerning the development of TSIs 
and the progress made in the screening and elimination of the national rules. Then inputs 
from the rail sector (including manufacturers and railway undertakings) were used on the 
resulting cost savings that have arisen as a result of the Agency’s outputs to this point. 
Information was collected from the Agency and the NSAs (through survey/data requests) 
on  the  resources  allocated  for  the  development  of  the  necessary  structures  and  tools 
implementing  the  4th  Railway  Package  (e.g.  OSS,  guidance  documents).  In  addition, 
Annual Reports, SPDs produced by ERA were reviewed as well as other documents (e.g. 
Management  Board  meeting),  supplemented  with  input  from  interviews  with  Agency 
management/staff  concerning  the  presence  of  issues/problems  and  the  role  of  the 
availability of relevant resources in that respect.  

The analysis from the effectiveness criterion was used, which examined the outcomes of 
the implementation of the Fourth Railway Package and the achievement of its objectives 
and compare them with the respective costs of the implementation of the Fourth Railway 
Package based on the assessment of cost impact analysis in the previous questions.  

ratio.  Thus,  qualitative  analysis  was  used. 

Due to data limitation, it has not been possible to quantify all costs and benefits to develop 
a  benefit-cost 
the 
Agency/authorities/rail undertakings was used to identify areas where further cost savings 
(either in the preparatory actions or in the implementation) could be achieved without an 
impact on the achievement of the objectives.  

Input 

from 

•  Relevance (see Table 10 in Annex III) 

The focus of the analysis of the relevance of ERA was on understanding whether the initial 
activities of the Agency were still relevant in view of the current needs of the rail sector, 
and expected economic, societal, environmental, technological, and policy developments. 
Key aspects to examine were the extent to which the technical pillar of the 4th Railway 
Package and its associated provisions, are still appropriate in view of the needs of the rail 
sector. 

It was also assessed if any new needs/problems have arisen, to determine if the original 
problem definition is still relevant. This involved analysing relevant indicators and was 
supported  by  desk  research  (e.g.  studies  analysing  the  current  trends  and  future  of  rail 
transport)  and  input  from  stakeholders  to  identify  whether  the  new  trends  may  have 
introduced  new  needs/problems  in  regard  to  rail  safety,  interoperability  and  ERTMS 
deployment.  Based  on  logical  analysis  and  input  from  relevant  stakeholders  (e.g. 
representative bodies, standardisation bodies, EU institutions, applicants, RISC Member 
State representatives, NSAs, NIBs, civil society), it was then examined how the specific 

89 

 
objectives  correspond  to  the  identified  needs  (whether  they  are  still  appropriate  and/or 
ambitious enough). 

•  EU-added value (see Table 11 in Annex III) 

The assessment of the EU added value examined the extent to which the extended role of 
ERA  has  brought  specific  and  additional  benefits  beyond  that  which  would  have  been 
possible based on potential action at other levels (e.g. national, regional, local etc.). 

Input from the desk research was used to inform the analysis of the specific contribution 
of  EU  action,  regarding  the  benefits  associated  with  a  single  consolidated  legislative 
framework  and  the  removal  of  unnecessary  administrative  and  technical  barriers.  Field 
research (e.g. surveys with applicants, NSAs and RISC representatives, interviews with 
the Agency, representative bodies, EU institutions) used to complement this analysis by 
obtaining input on the specific benefits brought by the presence of EU action. 

The baseline developed in the context of the support study was drawn upon to assess the 
potential impact of national level action on addressing the underlying problems which the 
Agency has been tasked to  manage (e.g. long  and costly authorisation  and certification 
procedures).  Moreover,  input  from  key  stakeholders  was  used  to  determine  the  type  of 
national actions which would have been adopted, and the expected impact of these actions 
(in the case that the Agency’s mandate had not been extended in 2016, to take further EU-
level action). 

•  Coherence (see Table 12 in Annex III) 

The assessment of the coherence aimed to identify the external and internal coherence of 
the Agency. The coherence of the Agency’s mandate with the other interventions to create 
the  SERA  and  EU  rail  policy  is  closely  linked  to  the  coherence  of  the  Agency’s  key 
activities (e.g. VA and safety certification, OSS and implementation of ERTMS) with the 
other interventions to create the SERA. Further, two dimensions of the external coherence 
were  explored,  i.e.,  the  coherence  of  the  Agency’s  mandate  and  key  activities  with  the 
other  interventions  to  create  the  SERA  and  EU  rail  policy,  and  the  coherence  of  the 
Agency’s mandate and objectives with the Green Deal and the ambitions towards smart 
and sustainable transport. The internal  coherence, i.e. the extent to which the Agency’s 
provisions, activities and priorities are consistent with one another, was also assessed. 

The analysis largely involved a desk-based mapping exercise, comparing the mandate and 
objectives  of  the  Agency  with  EU  rail  policy,  and  in  particular,  the  interventions  to 
complete the SERA. This aimed at identifying the level of consistency regarding ambition 
and scope, as well as capturing any overlaps or contradictions. The coherence of the scope 
and ambition of the objectives of the Agency with EU rail policy was also explored through 
engagement with stakeholders. 

90 

 
ANNEX III. EVALUATION MATRIX AND, WHERE RELEVANT, DETAILS ON ANSWERS TO THE EVALUATION QUESTIONS (BY CRITERION) 

Table 8. Evaluation matrix - effectiveness questions 

EQ1. To what extent has the Agency managed to achieve its objectives contributing to the development and effective functioning of the Single European 
Rail Area, with regards to:  

a.  Maintaining a high level of railway safety and interoperability in the EU   

b.  Eliminating operating barriers and overcoming the fragmented set of national frameworks and rules  

c.  Supporting rail sector competitiveness and innovation deployment by reducing administrative costs of authorisation processes, operating and 
running rail service and reducing time to market for innovation   

d.  Performing the role of Union authority responsible for issuing authorisations for placing in the market railway vehicles and vehicle types, issuing 
SSCs for railway undertakings and issuing ERTMS system approvals.   

Operational questions  

1a 

To what extent has the Agency contributed to promoting 
an effective approach to railway safety by: 

Indicators  

Quantitative indicators: 

Output indicators 

-  Developing requirements for a common EU approach 

to safety management? 

- 

Promoting and monitoring the implementation of a 
common EU approach to safety management? 

-  Dissemination and training activities? 

-  Number of CSMS, CSIs and TSIs developed 

-  Length  of  new  tracks  equipped  or  contracted  with  ERTMS 
(European  Train  Control  System  (ETCS)  and/or  Global 
System for Mobile Communications – Railway (GSM-R)) in 
SERA 

-  To what extent has the Agency contributed towards 

-  Degree of implementation of TAP and TAF functions    

ensuring vehicle interoperability by: 

-  Developing/delivering relevant TSIs? 

- 

Portion  of  TEN-T  core  network  and  rail  freight  corridors 
equipped with ERTMS 

- 

- 

Supporting the deployment of ERTMS systems 
compliant with TSIs? 

Result/ Impacts  

-  Number  of  railway  fatalities  and  injuries  and  number  of 

Supporting the deployment of telematics applications 
for passengers and freight compliant with TSIs? 

serious accidents reported 

Qualitative indicators: 

-  Level of compliance with SMS requirements 
-  Level of compliance with TSIs  

Data sources 

•  Desk research  

•  Analysis of relevant 

documentation (e.g. ERA Annual 
Activity Reports, ERA SPDs, ERA 
annual safety and interoperability 
performance reports, EU Statistical 
Pocketbook, key policy 
documents)  

•  Targeted surveys and interviews 

with key stakeholders (e.g. NSAs, 
ERA, railway undertakings and 
other industry etc.). 

91 

 
 
 
 
 
 
  
1b 

To what extent has the Agency contributed to eliminating 
operating barriers and overcoming the fragmented set of 
national frameworks and rules: 

-  By supporting the harmonisation of national rules for 

railway safety, vehicle operation and ERTMS 
deployment? 

-  By providing dissemination and training support for 

the implementation of the EU framework? 

-  Extent  that  stakeholders  agree/disagree  that  the  Agency  has 
had a positive role in the development and adoption of TSI, 
CSMS, CSIs  

-  Extent  that  stakeholders  agree/disagree  that  the  Agency 
contributed to a more effective approach to railway safety and 
interoperability through its specific activities.  

Quantitative indicators: 

Outputs 

-  Number of national rules analysed 

-  Number of Member States with rules cleaned up and 

published in the RDD and SRD 

-  Number of training modules delivered via the ERA Academy 

annually  

-  Number of dissemination activities implemented annually by 

ERA. 

Qualitative indicators: 

-  Extent that stakeholders agree/disagree that the Agency 

contributed to improving the coherence of national rules and 
framework 

Extent that stakeholders agree/disagree that the Agency’s actions 
on disseminating and training support have contributed to 
implementing the EU safety and interoperability framework. 

1c 

To what extent has the Agency supported rail sector 
competitiveness: 

Quantitative indicators: 

Outputs: 

-  By reducing the costs for SSC approvals/ vehicle (and 
vehicle type) approvals/ ERTMS trackside equipment 
approvals? 

-  By contributing to reducing the costs of operating and 
running rail services (e.g. through the reduction of 
opportunity costs as a result of reduced time for 
authorisation) 

To what extent has the Agency supported the deployment 
of rail sector innovation: 

-  Time  and  associated  costs 

for  safety  certifications, 
authorisations and ERTMS equipment approvals by ERA and 
NSAs 

-  Number of TSI developed in relation to innovative products 

(technologies/material/etc) 

-  Number  of  activities  related  to  Shift2Rail/EU  Rail  Joint 

Undertaking. 

Results/impacts 

92 

•  Desk research  

•  Analysis of relevant 

documentation (e.g. ERA Annual 
Activity Reports, ERA SPDs, ERA 
annual safety and interoperability 
performance reports, EU Statistical 
Pocketbook, key policy 
documents)  

•  Targeted surveys and interviews 

with key stakeholders (e.g. NSAs, 
ERA, railway undertakings and 
other industry etc.). 

•  Desk research  

•  Analysis of relevant 

documentation (e.g. ERA Annual 
Activity Reports, ERA SPDs, ERA 
annual safety and interoperability 
performance reports, Report on the 
competitiveness of the rail supply 
industry, key policy documents)  
•  Targeted surveys and interviews 

with key stakeholders (e.g. NSAs, 

 
 
 
-  By identifying and facilitating the uptake of new 

technologies (equipment/material) and digitalisation 
through the adoption of relevant technical 
specifications and other relevant standards  

-  Level  of  reduction  on  respective  costs  for  obtaining 
SSC/VA/ERTMS in comparison to the situation prior to the 
implementation of the 4th Railway Package 

-  Level  of  reduction  on  costs  for  operating  and  running  rail 

-  By reducing the time for the uptake and deployment 

services linked to the Agency activities 

of new vehicle and equipment  

-  Number of new  vehicle types and ERTMS equipment types 

ERA, railway undertakings and 
other industry etc.). 

-  By supporting relevant innovation initiatives 

(including as part of the Shift 2Rail/EU Rail Joint 
Undertaking). 

deployed in SERA. 

Qualitative indicators: 

-  Extent that stakeholders agree/disagree that the submission of 

applications to the Agency has contributed to: 

o  Speeding up and reducing the cost of deploying rail 

sector innovation 

o  Speeding 
equipment 

the  approval  of  ERTMS 

trackside 

-  Extent  that  stakeholders  agree/disagree  that  the  Agency  has 
innovative 

facilitated 
technologies and promotion of digitalisation in the sector 

the  adoption/market  uptake  of 

1d 

Has the Agency successfully performed the role of Union 
authority responsible for: 

Quantitative indicators to include: 

Outputs 

-  Extent that stakeholders agree/disagree that ERA’s support to 
the following activities have contributed to the development 
of innovation in the rail sector.  

- 

Issuing authorisations for placing in the market 
railway vehicles and vehicle types  

- 
Issuing SSCs for railway undertakings;  
-  Approving ERTMS trackside systems. 

How has the functioning of the Agency in this role 
contributed to: 

-  Higher quality standards applied in the processing of 

applications? 

- 

Increased flexibility of the application process? 

•  Total number of applications submitted and processed by ERA 

for: 

o  Safety certificates. 

o  Vehicle and vehicle type authorisations. 

o  ERTMS trackside equipment approvals. 

•  Desk research  

•  Analysis of relevant 

documentation (e.g. ERA Annual 
Activity Reports, ERA SPDs, ERA 
annual safety and interoperability 
performance reports, Report on the 
competitiveness of the rail supply 
industry, key policy documents)  

•  % of multi-country applications 

•  Analysis of data from OSS and 

•  Proportion  of  decisions 
framework deadlines. 

Qualitative indicators: 

93 

taken  according 

to 

the 

legal 

registers  

•  Targeted surveys and interviews 
with key stakeholders (e.g. 
applicants, NSAs, ERA, competent 
authorities.). 

 
 
 
 
•  Extent that stakeholders agree/disagree that the Agency has 
fulfilled its role as Union authority responsible for these 
approvals, certifications and authorisations 

•  Extent that stakeholders indicate preference to submit 

applications to ERA 

•  Extent that stakeholder consider that ERA involvement has 
led to improvement to the quality of the application process 

•  Level of flexibility in application procedures (e.g. 

shortened/light procedure for application approvals by NSAs 
or ERA under specific conditions). 

EQ2. Which factors have contributed to/hindered the achievement of general and specific objectives?  

2a 

What external drivers/parameters have played a positive or 
negative role in the implementation of ERA activities and 
the achievement of ERA’s objectives, such as: 

•  Technology  developments  related  to  rail  vehicles  or 
infrastructure (e.g. increased need for authorisation for 
systems based on new/advanced technologies) 

•  Market  developments  (level  of  demand  for  railway 

services) including the impact of COVID.  

Qualitative indicators: 

Stakeholder stated views on the impact of market developments 
on ERA activities 

Stakeholder stated views on the impact of technology 
developments on ERA activities 

Extent that stakeholder consider that the COVID-19 pandemic 
had a negative impact on the delivery of ERA objectives. 

2b 

What internal factors have had an impact on the 
implementation of the 4th Railway Package and the 
Agency’s operation and achievement of its objectives, 
including: 

•  Speed of transposition of 4th Railway Package by 

Member States 
•  Access to resources 

•  Agency’s working practices,  

• 

Interaction/cooperation with national authorities 

What other internal drivers/parameters related to the 
implementation of the 4th Railway package and the 
Agency’s operation have played a positive or negative role 

Qualitative indicators: 

•  Level of impact of the internal factors in the effective delivery 
of the Agency’s responsibilities and achievement of objectives  
•  Extent  that  stakeholders  consider  that  identified  internal 
parameters  had  a  significant  impact  on  the  delivery  of  the 
Agency’s objectives. 

•  Desk research 

•  Analysis of relevant documents 

such as:   ERA SPDs and Annual 
Activity Reports 2016-
2022.Management Board, 
Commission and IAS 
opinions/reports, Industry position 
documents) 
•  Targeted surveys 

•  Targeted interviews  

•  Desk research 

•  Analysis of relevant 

documentation (ERA Annual 
Activity Reports, ERA SPDs, 
Management Board, Commission 
and IAS opinions/reports, Industry 
position documents 

•  Targeted surveys 

•  Targeted interviews. 

94 

 
 
 
 
 
in the implementation of ERA activities and the 
achievement of ERA’s objectives?   

EQ3. What actual observed effects (positive and negative impacts) has the Agency achieved? Have there been any unexpected or unintended effects? 

3 

What, if any, have been the direct effects of the 
functioning of the Agency to this point in relation to: 

•  Elimination of redundant national rules 

•  Delivering a single information and communication 

system for all the applications across Europe 

•  Monitoring performance and decision-making of 

NoBos and NSAs 

•  Reducing the cost and duration of the VA and safety 

certification 

•  Ensuring development of telematics and ERTMS 
deployment and harmonised ERTMS technical 
solutions 

•  Achieving high level of technical, operational and 

safety harmonisation in the railway sector 

Quantitative indicators: 

•  Number of applications for safety certification, 

authorisations and ERTMS approvals processed (and level of 
increase in relation to the baseline (without the 4th Railway 
Package) and in comparison to the targets set in the 2013 IA 
study) 

•  Number of national rules reviewed/eliminated (comparison 

with the baseline and the targets set in the IA study) 

•  Level of cost and time reductions achieved from the VA and 
safety certification (in comparison to the target of 20% stated 
in the IA) 

Qualitative indicators to include: 

•  Desk research 

•  Analysis of relevant 

documentation (ERA Annual 
Activity Reports, ERA SPDs, 
Impact assessment of the 
Regulation on the European Union 
Agency for Railways, ERA Safety 
and Interoperability Reports) 

•  Targeted surveys 

•  Targeted interviews. 

•  Extent 

that  Agency  activities  have 
coherence/harmonisation of the legal framework 

led 

to 

increased 

•  Promoting rapid deployment of innovation across the 

•  Extent that Agency activities have reduced time to market  

rail sector 

Have there been any side-effects in the railway market that 
were not expected? (e.g. employment impacts)? 

Have there been any unintended (positive or negative) 
effects as a result of the new role of the Agency in the 
economic, social and environmental domains?  

•  Stakeholder  views  regarding  unintended  and  unexpected 
impacts of the Agency’s functioning on the rail industry 

•  Stakeholder  views  regarding  unintended  and  unexpected 
impacts of the Agency on broader society (e.g. environmental, 
social impacts etc.). 

EQ4. How has the OSS impacted the: 

a. Time needed to obtain approvals? 

b. Transparency and visibility of the approval process and decisions for applicants? 

95 

 
 
4a 

What has been the impact of the introduction of the OSS 
on: 

Quantitative indicators: 

•  Desk research 

•  Change in time needed to obtain an SSC and vehicle/vehicle 

•  Analysis of relevant 

•  The  overall  time  needed  to  obtain  approvals  when 

type authorisation. 

applications are submitted to ERA or NSAs? 

Qualitative indicators: 

•  The predictability of the time needed for each step of 

the approval process? 

•  Stakeholder  (applicant)  perception  of  the  impact  of  the 

introduction of OSS on the overall time needed. 

documentation (OSS process 
documentation) 

•  Targeted surveys 

•  Targeted interviews 

•  Targeted surveys 

4b 

What has been the impact of the introduction of the OSS 
on the: 

Qualitative indicators: 

•  Level of information available on the requirements and steps 

•  Targeted interviews 

•  Transparency of the steps of the approval process and 

of the approval process 

their requirements? 

•  Availability of guidance material assisting the preparation of 

•  Predictability of the outcome of the approval process? 

applications 

•  Availability of information for applicants regarding the state 

of their applications 

•  Stakeholder  (applicant)  perception  of  the  impact  of  the 

introduction of the OSS on the: 

o  Transparency/clarity of the approval process 

o  Predictability of the outcome of the approval process.  

EQ5. Have the enhanced role of the Agency for vehicle authorisation and safety certification and the harmonised implementation of ERTMS (including 
the extension of area of use or area of operations and the operation of the dual system) delivered the expected outcomes? In particular, have the 
provisions: 

a. Reduced administrative burden across the Union’s rail sector?  

b. Improved the time to market for the deployment of rail innovation? 

c. Impacted the provision of cross-border rail services? 

5a 

Has the operation of the dual system contributed to the 
reduction of the administrative burden for applicants? 

Quantitative indicators: 

Output 

What were the main factors driving changes in 
administrative costs?  

•  Total  number  of  applications  due  to  the  issue  of  SSCs  for 

multiple Member States by ERA 

•  Total number of applications due to the issue of vehicle (type) 

authorisations for multiple Member States by ERA 

Qualitative indicators: 

96 

•  Desk research 

•  Analysis of relevant 

documentation (ERA Annual 
Activity Reports, ERA SPDs, Data 
on the use of OSS/ERADIS) 
•  Data requests to stakeholders 

•  Targeted surveys 

 
 
 
5b 

Have the provisions of the ERA regulation contributed 
towards improving the time to market for the deployment 
of rail innovation?  

What were the main factors driving changes in application 
processing times? 

•  Stakeholder  perception  of  the  impact  of  the  dual  system  in 

•  Targeted interviews 

reducing/increasing administrative burden. 

Quantitative indicators: 

•  Desk research 

•  Time  required  for  SSC  (issue,  renewal,  suspension  and 

•  Analysis of relevant 

amendment) by ERA and NSAs 

•  Time  required  for  vehicle  and  vehicle  type  authorisation 
(issue, renewal, amendment, suspension and revoke) by ERA 
and NSAs 

documentation (ERA Annual 
Activity Reports, ERA SPDs) 
•  Data requests to stakeholders 

•  Targeted surveys 

•  Time required for ERTMS equipment approval by ERA and 

•  Targeted interviews 

5c 

Have the provisions of the ERA regulation had an impact 
on the provision of cross-border rail services? 

NSAs. 

Qualitative indicators: 

•  Extent that stakeholders agree/disagree that the submission of 
applications to the Agency has contributed to speeding up and 
reducing the cost of deploying rail sector innovation. 

Qualitative indicators to include: 

Extent that stakeholders agree/disagree that the submission of 
applications to the Agency has contributed to deploying cross-
border services. 

Key pieces of literature and data 
sources to include: 

ERA Annual Activity Reports 2014-
2019; 

ERADIS (data on licences to provide 
rail transport services and number of 
multi-country SSCs) 

Action plan to boost long distance and 
cross-border passenger rail 

This will be complemented by surveys 
and interviews with key stakeholders 
(e.g. Rus, manufacturers and NSAs). 

Data requests to stakeholders (e.g. Rus, 
manufacturers and NSAs) will also be 
circulated. 

EQ6. How effective have the new processes put in place regarding the Agency’s technical support been, with regard to achieving the Agency’s objectives. 
In particular: 

a. How effective is the monitoring by the Agency of NSAs and NoBos? 

97 

 
 
 
 
b. Has the Agency’s technical support in the field of railway safety and interoperability been effective?  Has the expected support been 
delivered/provided within the legal deadlines set out on Article 10 of Regulation (EU) 2016/796? 

6a 

To what extent has the Agency exercised its new powers 
of monitoring NSAs and NoBos? 

Quantitative indicators: 

•  Desk research 

•  Number of inspections and audits of NSAs and NoBos 

•  Analysis of relevant 

To what extent have the new monitoring practices led to: 

• 

harmonisation  of  performance,  organisation  and 
decision making of the NSAs? 

• 

harmonisation of performance of NoBos? 

6b 

How far have technical opinions and studies contributed 
towards improving safety-related or interoperability-
related rules or procedures? 

Have technical opinions been issued& published within 
the legally defined timeframe (issued two months of 
receipt of the request and made public within one month 
after they are issued)? 

Have all technical opinions published from 2018 onwards 
been complemented by an impact assessment?  

•  Number  of  deficiencies  and  recommendations  identified  in 

reports issued for NSAs and NoBos. 

Qualitative indicators: 

•  Extent  that  stakeholders  agree/disagree  that  the  Agency’s 
monitoring  activities  contributed  to  improving  the  operation 
of NSAs and harmonising their performance 

•  Extent  that  stakeholders  agree/disagree  that  the  Agency’s 
monitoring  activities  contributed  to  improving  the  operation 
of NoBos and harmonising their performance. 

documentation (ERA Annual 
Activity Reports, ERA SPDs, ERA 
Reports on Railway Safety and 
Interoperability (Performance) in 
the EU) 

•  Targeted surveys 

•  Targeted interviews 

Quantitative indicators: 

•  Desk research 

•  Number of technical opinions (with/without IAs) issued in the 

•  Analysis of relevant 

fields of rail safety and rail interoperability 

•  Proportion  of  technical  opinions  issued  and  made  public 

within the legally defined timeframes. 

Qualitative indicators: 

•  Factors causing delays in the issue and publication of technical 

opinions 

•  NSA views on the quality of ERA technical opinions 

•  NSA  views  on  the  extent  to  which  ERA  technical  opinions 
improvement  of  rail  safety  and 

the 

have  supported 
interoperability.  

documentation (ERA Annual 
Activity Reports, ERA SPDs, ERA 
opinions, guidance documents, 
webinars for industry, NSA 
Network, ERA attendance at NB-
Rail meetings and monitoring of 
NoBo activities) 
•  Targeted surveys 

•  Targeted interviews 

•  Data requests from ERA  

EQ7. Do the various IT tools and databases (registers) put in place by ERA sufficiently contribute to the delivery of overall ERA objectives? How far has 
the Agency’s responsibility to set up EU-level registers led to the:  

a. Establishment of specific registers with safety and interoperability related data taking into account user needs? 

b. Use of the Agency’s registers by relevant rail stakeholders? 

c. Data completeness in these registers? 

98 

 
 
 
 
7a 

To what extent have the new tools and EU-wide registers 
put in place by ERA considered specific user needs of the 
following processes:  

•  ERA’s internal processes 

•  Processes of national bodies 

•  Processes of industry stakeholders. 

7b 

To what extent have ERA registers been accessed and used 
by stakeholders? 

7c 

Did the use of ERA Registers lead to extended data 
availability (i.e. increased country coverage) 

To what extent have the ERA registers improved data 
completeness with respect to situation prior to the adoption 
of the 4th Railway Package? 

Qualitative indicators: 

•  Desk research 

•  Feedback process applied in the development of the tools to 

•  Analysis of relevant 

documentation (ERA Annual 
Activity Reports, ERA SPDs, 
Relevant Information on the IT 
tools and their use and registers 
available via the ERA website) 

•  Targeted surveys 

•  Targeted interviews 

•  Data requests from ERA  

integrate user needs 

•  Stakeholder  views  on  the  added  value  of  individual  ERA-

developed tools with regards to promoting rail safety 

•  Stakeholder  views  on  the  added  value  of  individual  ERA-
rail 

tools  with 

promoting 

regards 

to 

developed 
interoperability. 

Qualitative indicators: 

•  Types of stakeholders using the ERA-developed tools 

•  Stakeholder views on the extent to which registers are easy to 

use. 

Quantitative indicators to include: 

Level of data completeness in each of the registers developed by 
ERA (in comparison to comparable national databases), where 
relevant. 

Qualitative indicators to include: 

Stakeholder views on the completeness of the content of 
individual tools. 

EQ8. How is ERA activity in the Western Balkan region under the IPA programme contributing to the overall objective of enhancing cooperation and 
support to these countries in view of future or potential EU membership? 

How far has the technical support provided by ERA 
contributed to institution building in the railway sector in 
Western Balkan countries? 

How far have ERA activities promoted rail safety in 
Western Balkan countries? 

To what extent have ERA activities (including the IPA 
summit) been an effective tool to engage with relevant 
stakeholders in the Western Balkan region? 

Quantitative indicators: 

Outputs 

•  Desk research 

•  Analysis of relevant 

•  Number of trainings and workshops delivered (and number of 

participants) in Western Balkan countries 

Results/Impacts 

•  Change  in  rail  safety  performance  in  Western  Balkan 

countries 

•  Level of adoption of relevant acquis by Candidate countries 

•  Existence and operation of the institutional framework (NSA, 

• 

NIB, regulatory body)   

Qualitative indicators: 

99 

documentation (ERA Annual 
Activity Reports, ERA SPDs, Rail 
Action Plan for Developing a 
Regional Rail Strategy in the 
Western Balkans and progress 
reports, ERA internal IPA 
activities documentation) 
Interview with key stakeholders 
(e.g. Permanent Secretariat of the 
Transport Community Treaty, 

 
 
 
 
 
 
 
•  Candidate  countries  authorities  views  on  the  usefulness  of 

ERA’s support activities in: 

o 

o 

Improving rail safety 

Institutional capacity building 

•  Converging with EU law on rail operations and safety. 

Western Balkan NSAs, DG 
NEAR). 

EQ9. Are the working practices of the Agency as set out by Regulation (EU) 2016/796 sufficiently supporting the Agency’s objectives and sector needs?  

a. What has been the contribution of the developed working groups and parties in achieving the Agency’s objectives and sector needs on the themes of 
TSIs, CSTs, CSMs and the use of CSIs? 

b. Are the working parties created under Article 5 of Regulation (EU) 2016/796 sufficiently inclusive and representative? 

9a 

What have been the contributions of the working groups 
and parties in achieving the Agency’s objectives? 

How have the working parties supported the improvement 
of rail safety in the SERA? 

How have the working parties supported the improvement 
of rail interoperability in the SERA? 

9b 

To what extent are ERA stakeholders sufficiently 
represented in the various working parties?  

•  Desk research 

•  Analysis of relevant 

documentation (ERA Annual 
Activity Reports, ERA SPDs, ERA 
Report on Railway Safety and 
Interoperability in the EU 2016-
2022, Agency documentation on 
the work conducted by working 
parties since 2016) 

•  Targeted surveys 

•  Targeted interviews 

Quantitative indicators: 

•  Number of meetings held (by each working party); 

•  Number of working party deliverables (i.e. recommendations, 

studies, technical opinions etc.); 

•  Number of TSIs, CSTs, CSMs and CSIs developed/revised. 

Qualitative indicators: 

•  Stakeholder views on the contributions in terms of rail safety 

brought by the working parties on CSTs, CSMs, CSIs. 

•  Stakeholder  views  on  the  contributions  in  terms  of  rail 

interoperability brought by the working party on TSIs. 

Quantitative indicators: 

•  Participation  of  individual  Agency  stakeholders  in  working 

parties.  

Qualitative indicators to include: 

•  Balanced  representation  of  all  relevant  Agency  stakeholder 

groups in the working parties. 

100 

 
 
 
 
 
Table 9. Evaluation matrix - efficiency questions 

Operational questions 

Indicators 

Data sources 

EQ10.   Has the role of the Agency in terms of the harmonisation through TSIs and elimination of national rules brought savings for the railway sector? 

10.1 To what extent has the Agency’s enhanced role under the 4th 
Railway Package in terms of the development and revision of TSIs 
has brought savings to the railway sector?  How significant where 
they?  

10.2 To what extent has the Agency’s work on the elimination of 
national technical rules has brought cost/time savings for the railway 
sector? How significant where they?  

Quantitative indicators: 

•  Number of developed TSIs 

•  Evolution on the number of national rules. 

Qualitative indicators: 

•  Desk research 

• 

 Analysis of relevant documentation 
(ERA Annual Activity Reports, 
Management Board meeting minutes, 
2013 Impact Assessment support 
study) 

•  Extent that stakeholders agree/disagree that the Agency 
has contributed to a greater level of harmonisation.  

•  Targeted surveys 

•  Targeted interviews 

•  Extent  that  stakeholders  agree/disagree  that  the  role  of 
the Agency in the elimination of national rules brought 
cost savings for the railway sector.  

EQ11. What were the actual resources used/spent to achieve the positive impacts? 

What have been the resources (human/financial) allocated by the 
Agency, the NSAs and industry for the development of the 
necessary support structures and procedures (i.e. OSS, development 
of guidance documents, training etc.)? 

Quantitative indicators: 

•  Total expenditure (in EUR) by the Agency to develop 
the new procedures/structures to implement the Fourth 
Railway Package 

•  Total human resources (in FTE) allocated by the 

Agency to develop the new procedures/structures to 
implement the 4th Railway Package 

•  The change in total human resources (in FTE) allocated 

by NSAs to implement the 4th Railway Package 

•  Desk research 

• 

• 

 Analysis of relevant documentation 
(ERA SPDs, ERA Annual Activity 
Reports, Management Board meeting 
minutes, 2013 Impact Assessment 
support study) 
Input provided by ERA staff 

EQ12. What were the costs of actual negative impacts, if any, to which the Agency’s role as per Regulation (EU) 2016/796 has given rise and how high 
were they? Whom did they fall upon?  

101 

 
 
 
 
 
12.1 Has the delivery of the Agency’s new/enhanced role in relation 
to each of the following led to any negative impacts in the form of 
longer timescales, costs or other negative impacts:  

-  Authorisation/certification and ERTMS approval process 

- 

Screening/elimination of national rules 

12.2 How significant are those impacts? 

12.3 Which stakeholders (authorities, NoBos, railway undertakings, 
infrastructure managers, others) experienced negative impacts as a 
result of the new role of the Agency? How significant were they?   

Quantitative indicators: 

•  Evidence from stakeholders on the scale cost increases 
(in EUR) resulting from the new/enhanced role of the 
Agency in the case of   
verification/certification/application process.  

Qualitative indicators: 

•  Presence (or not) and significance of negative impacts 

from the implementation of the ERA Regulation and the 
enhanced role of the Agency for specific categories of 
stakeholders. 

•  Desk research 

•  Targeted surveys 

•  Targeted interviews  

EQ13. Were the additional human and financial resources allocated to the Agency in the run up to the coming into operation of the 4th Railway Package 
sufficient and adequate to achieve its new tasks? If not, how has this impacted delivery of the Agency’s tasks under Regulation (EU) 2016/796? 

13.1 What have been the additional human and financial resources 
that were made available to ERA in the period up to June 2019 in 
preparation for the entry into force of the Fourth Railway Package? 

13.2 Were the additional resources available sufficient to allow the 
Agency to adequately prepare in relation to: 

• 

Implementation of all necessary practical arrangements in order 
to be able to deliver its role concerning VAs, SSCs, ERTMS 
trackside approvals  

Quantitative indicators: 

•  Additional human resources (in FTE) made available to 

the Agency during the period 2016 – 06/2019 

•  Additional financial resources (in EUR) made available 

to the Agency during the period 2016 – 06/2019 

•  Number (share) of the Agency’s tasks related to the 4th 
Railway Package preparation completed on time.  

•  The development, testing and operation of the OSS service 

Qualitative indicators: 

•  Desk research 

• 

 Analysis of relevant documentation 
(ERA SPDs, ERA Annual Activity 
Reports, Management Board meeting 
minutes, 2013 Impact Assessment 
support study) 
•  Targeted surveys 

•  Targeted interviews 

•  Development of the necessary support structures and tools (for 

businesses, authorities) 

•  Other necessary activities to support (directly or indirectly) the 

implementation of the new tasks related to vehicle 
authorisation, trackside approval and SSC activities.  

13.3 How do they compare with the initially expected additional 
financial resources (according to the impact assessment)?  

13.4 Have there been any specific areas where available resources 
proved to be insufficient? Did this mean that any of the preparatory 
tasks were not completed, only partially completed or delayed?   

•  Presence (or not) and significance of 

delays/issues/problems for the development of the 
necessary infrastructure (OSS) and support mechanisms 
related to the availability of resources. 

•  Presence (or not) and significance of issues/problems in 

the implementation/delivery of the Agency’s 
responsibilities concerning 
certification/authorisation/approval related to the 
availability of resources. 

•  Presence (or not) and significance of issues/problems in 

the implementation/delivery of the Agency’s 
responsibilities concerning other policy tasks related to 
the availability of resources. 

102 

 
 
EQ14. Are the working methods as set out in Chapter 2 of Regulation (EU) 2016/796 efficient? 

14.1 What have been the costs (human/financial resources) 
associated with each of the working methods: 

•  Setting up and operation of the working parties  

•  Development of recommendations and guidelines on TSIs 

•  Consultation activities 

• 

Impact assessments 

•  Studies/opinions 

•  Visits to Member States. 

14.2 Are the costs associated with each of the above justified on the 
basis of the outputs produced and their contribution to meeting their 
respective objectives?  

Quantitative indicators: 

Input 

•  Total  (annual)  budget  and  human  resources  (in  FTE) 
allocated and cost per unit (where relevant) to each of the 
following:  

o  Setting up and operation of the working parties 

o  Development of recommendations and guidelines 

on TSIs 

o  Consultation activities 

o 

Impact assessments 

o  Studies/opinions 

o  Visits/audits  and  technical  support  provided  to 

NSAs and NoBos. 

Qualitative indicators to include: 

•  The  extent  that  stakeholders  consider  that  costs  of 
each  of  the  working  practices  are  justified/not 
justified.  

•  Desk research 

• 

 Analysis of relevant 
documentation (ERA SPDs, ERA 
Annual Activity Reports) 

•  Targeted surveys 

•  Targeted interviews 

EQ15. To what extent has the organisation and management of the Agency been cost-efficient?  What has been the role of the management and executive 
board, the 4th Railway package steering group and the supervision by the European Commission in ensuring the efficiency of the Agency activities? 

15.1 What have been the total human/financial resources allocated to 
the organisation and management activities of the Agency (e.g. 
administration staff)?  

15.2 What share of the total human/financial resources does this 
represent? How do they compare with other EU agencies with a 
similar role/structure (e.g. EASA, EMSA?)   

15.3 How effective are the internal and external monitoring and 
assessment processes in place in ensuring the efficient delivery of 
the Agency’s responsibilities?  

Quantitative indicators: 

•  Share of human and financial resources allocated to 

organisation and management aspects. 

Qualitative indicators: 

•  Presence of relative performance (KPI) indicators 

monitoring efficiency and mechanisms to act upon. 

•  Extent that stakeholders consider that internal and 
external monitoring procedures ensure the efficient 
operation of the Agency.    

•  Desk research 

• 

 Analysis of relevant documentation 
(ERA SPDs, ERA Annual Activity 
Reports, Opinions/decisions of the 
management board, the EC and 4th 
Railway Package Steering Group, 
Similar documents from other EU 
agencies) 

•  Targeted surveys 

•  Targeted interviews 

• 

Input from Agency staff  

103 

 
 
 
15.4  Are  there  relevant  indicators  in  place  to  help  monitor  the 
efficiency of the Agency’s operation?  

15.5 What has been the role of each of the following in ensuring the 
efficiency of the Agency’s activities: 

•  Extent that organisation and management resources are 
considered appropriate by stakeholders to ensure the 
efficiency of the Agency’s operations. 

-  The management and executive board 

-  The 4th Railway Package steering group 

-  The European Commission. 

 EQ16. To what extent does the Agency’s human resources management contribute to the achievement of its objectives? 

16.1 Do the current human resources management and staffing 
activities (including recruitment processes, agreements with national 
authorities, training, career management) ensure availability of the 
necessary resources and expertise (in quantity/quality) to deliver on 
ERA’s activities, tasks and objectives?  

16.2 Have there been any disruptions/delays to the delivery of the 
activities and objectives of the Agency due to absence of 
necessary/appropriate human resources (in terms of numbers and 
relevant expertise)?  

•  Desk research  

•  Analysis of relevant documentation 
(e.g., ERA SPDs, ERA Annual 
Activity Reports, ERA Strengthening 
Plan) 

•  Targeted surveys 

•  Targeted interviews 

• 

Input from Agency staff  

Quantitative indicators: 

Input 

•  Evolution of Agency staff (total and by level) 

•  Number of external staff (seconded national experts, 

experts from NSAs) 

•  Gender balance within the Agency 

•  Staff turnover rate 

•  Number of cases where limited availability of resources 

led to problems/delays    

•  Number of ERA actions that had to be 

postponed/cancelled due to lack of resources. 

Qualitative indicators: 

•  Extent that relevant stakeholders (Agency staff, 

Management Board, national authorities) agree/disagree 
that the Agency‘s human resources management 
processes have ensured access to required resources.  

EQ17. What is the impact of the dual seat (Lille and Valenciennes) on ERA’s working methods and its costs? 

17.1 How do the dual headquarters impact the delivery of ERA’s 
outputs? In what way?  

17.2 What are the costs of operating the dual ERA headquarter 
structure? 

Quantitative indicators: 

•  Number of meetings taking place annually in the Lille 

premises and participation of ERA staff. 

•  Desk research  

•  Analysis of relevant documentation 
(e.g., ERA SPDs, ERA Annual 
Activity Reports) 
•  Targeted surveys 

104 

 
 
 
 
 
•  Mission and travel costs incurred by the Agency as a 

•  Targeted interviews 

result of the dual seat. 

•  Data requests to Agency staff  

•  Additional costs of retaining and operating a dual seat 

structure (overhead costs). 

Qualitative indicators: 

•  Extent that the dual seat is considered to have an impact 
(positive/negative) on the delivery of ERAs outputs  

•  Types of practical issues related to the dual seat 

•  Views of ERA staff on the practical issues affecting their 

workflow related to the dual seat. 

EQ18. To what extent is the Agency’s internal organisation sufficiently capable and flexible to rapidly respond to resource needs due to uncertainties 
related to the dual transposition dates of the 4th Railway Package technical pillar? 

18.1 How has the level of workload for certification/authorisation 
changed during the period since June 2019?  

18.2 Have the differences in the transposition of the 4th Railway 
Package affected the demand for authorisation/certification activities 
and if so, to what extent? 

18.3 Has the Agency ensured access/availability to necessary 
additional resources to respond to the changes in the workload for 
certification/authorisation? 

18.4 What were the implications in terms of the delivery of the 
policy related tasks as a result of fluctuation in demand for 
authorisation/certification?   

Quantitative indicators: 

•  Allocation of FTEs for authorisation work vs rail related 

policy tasks. 

Qualitative indicators: 

•  Frequency of gaps between resources needed to address 

level of demand and resources available.  

•  Frequency of cases where limited availability of 

resources led to problems/delays to the processing of 
applications. 

•  Extent that relevant stakeholders (Agency staff, 

Management Board, national authorities) agree/disagree 
that the Agency has appropriate mechanisms to respond 
to future variations in demand. 

•  Extent that allocation of resources on 

authorisation/certification tasks has affected the delivery 
of other tasks. 

EQ19. Which aspects/means/actors/stakeholders or processes render the Agency more or less efficient? 

•  Desk research  

•  Analysis of relevant documentation 
(e.g., ERA SPDs, ERA Annual 
Activity Reports, ERA Strengthening 
Plan) 

•  Targeted surveys 

•  Targeted interviews 

•  Data requests to Agency staff  

105 

 
 
 
 
  
19.1 Which specific internal processes and structures of the Agency 
(including IT tools, working methods under Chapter 2) are more or 
less  cost-effective?  How  significant  is  their  role  in  the  Agency’s 
overall efficiency?  

19.2 What has been the role of stakeholders/actors involved in the 
implementation of the 4th Railway Package and the Agency’s 
processes (e.g. NSAs, NoBos) that have a positive/negative impact 
on the costs and efficiency of the Agency’s processes? How 
significant are these?  

Qualitative indicators: 

•  Relative contribution (positive/negative) of the different 
Agency’s operations in its overall cost-efficiency 

• 

 Presence and significance of a positive/negative role of 
specific stakeholders in the efficiency of the Agency 
operations.  

•  Desk research  

•  Analysis of relevant documentation 
(e.g., 2011 Evaluation of Regulation 
881/2004 establishing the European 
Railways Agency, ERA Strengthening 
Plan) 

•  Targeted surveys 

•  Targeted interviews 

•  Data requests to Agency staff  

EQ20. Have the Agency’s results/deliverables led to increased regulatory burden? If so, is there room to simplify or reduce any unnecessary costs? 

20.1 Have any of the following Agency’s activities/processes led to 
new/additional regulatory burden for any stakeholders (rail 
businesses and NSAs): 

authorisation and certification activities  

Quantitative indicators: 

•  Case studies on regulatory costs for railway businesses 
related to authorisation and certification outputs by 
ERA. 

policy tasks. 

Qualitative indicators to include: 

- 

- 

20.2 What are the drivers of these additional costs?  

20.2 Could any of the above cost drivers be simplified/eliminated 
without any impact on the effectiveness of the process?    

•  Share of stakeholders that consider that ERA processes 
and procedures have led to an increase/decrease in the 
regulatory costs. 

•  Desk research  

•  Analysis of relevant documentation 
(e.g. 2013 Impact Assessment, ERA 
Annual Activity Reports, ERA SPDs, 
ERA Strengthening Plan) 

•  Targeted surveys 

•  Targeted interviews 

•  Data requests to Agency staff  

EQ21. How do the actual effects and positive impacts compare to the actual costs and any negative impacts in terms of orders of magnitude/in size? 
Were they achieved at a “reasonable” cost?80 Could the same results have been achieved with less funding/lower cost/less staff? 

21.1 How do the costs for the Agency and authorities for the 
implementation of the 4th Railway package compare with the level 
of achievement of the expected results and the impacts?  

21.2 Are they in line with the expected costs and savings at the time 
of the adoption of the 4th Railway Package (according to the impact 
assessment)? 

Quantitative indicators: 

•  Total costs for the Agency and for authorities over 

the period 2016-2021 and per type.   

•  Total savings for rail undertakings, ERA and 
authorities over the period 2016-2021.  

•  Ratio of costs to benefits.  

•  Desk research  

•  Analysis of relevant documentation 

(e.g. 2013 Impact Assessment, Annual 
Activity Reports, ERA Strengthening 
Plan) 

•  Targeted surveys 

•  Targeted interviews 

80 'Cost' means in case of programmes/actions any financing provided and in case of other policies administrative/monitoring/compliance/enforcement costs. 

106 

 
 
  
21.3 Were there aspects of the costs for the implementation of the 4th 
Railway Package that could have been avoided with no impact on 
the effectiveness, in terms of: 

•  Level of funding from the EU budget. 

•  Resources/staff allocated. 

Qualitative indicators: 

•  Data requests to Agency staff  

•  Extent that the costs incurred are justified by the 

benefits and outcomes achieved  

•  Presence and significance of possible cost savings.  

Table 10. Evaluation matrix - relevance questions 

EQ22. Do the original objectives and activities of the Agency correspond to the current needs of the rail sector in the Union and in the foreseeable future? 
Does the introduction of the dual system for VA and safety certification, the OSS and harmonised implementation of ERTMS meet the needs of the rail sector 
in the Union? 

Operational questions  

Indicators 

22.1 To what extent are the problems/needs identified at the time of 
the adoption of Regulation (EU) 2016/796 still relevant today? 
Namely, are there still problems/needs related to:  

Qualitative and quantitative indicators relating to the 
existing problems/needs and problems/needs which may 
have emerged since 2016, including: 

•  Long and costly authorisation and certification procedures 

•  Authorisation and certification data (e.g. valid 

•  Discrimination against new entrants (e.g. discriminatory 
access to infrastructure, technical/regulatory barriers) 

•  Need to ensure safe and interoperable railway operations 

•  Lack of modernisation and innovation in the railway sector. 

22.2 Have any new needs emerged (or are any expected to emerge) 
in relation to the effective functioning of the rail sector in the EU, as 
a result of technological, economic, societal, environmental and 
policy trends that were not considered at the time of the expansion 
of the Agency’s mandate, including: 

SSCs issued) 

•  Rail safety data (e.g. significant rail accidents and 

casualties, fatality risk of rail transport) 

• 

• 

Interoperability data (e.g. ERTMS deployment, 
time spent on cross-border operations) 

Innovation and modernisation data (e.g. level of 
funding for new technologies and innovation) 

•  Decarbonisation (e.g. percentage of electrified 

network). 

Data sources and methods  

•  Desk research  

•  Analysis of relevant documentation 

(e.g. ERRAC - Rail 2050 Vision; ERA 
- Report on a compelling vision for the 
target railway system; EC – Rail 
Market Monitoring Survey; key policy 
documents)  

•  Targeted surveys 

•  Targeted interviews  

107 

 
 
 
 
   
 
Operational questions  

Indicators 

Data sources and methods  

Other needs may only be possible to address in a qualitative 
manner; these include: 

•  The extent to which stakeholders agree that the 

existing objectives of the Agency are relevant for 
the new problems/needs arising. 

•  The extent to which stakeholders agree that changes 

to the objectives of the Agency are needed. 

•  Technological developments (e.g. artificial intelligence 

(AI) applications, autonomous train operations, emerging 
communication systems and technologies (5G), innovative 
design of rail vehicles) 

•  Changing transport demand/modal shift (as a result of 
trends in oil prices/car ownership/high-speed rail 
infrastructure) 

•  Digitalisation and new service offerings (e.g. Mobility as a 
Service (MaaS), temporary capacity restriction (TCR)). 

• 

Increasing focus on decarbonisation (e.g. electrification of 
railways, alternative fuel use 

•  Demographic trends (e.g. urbanisation and associated rail 

connectivity 

•  COVID-19 and associated socio-economic impacts (e.g. 

train capacity changes, freight demand changes) 

•  Policy developments (e.g. European Green Deal, SSMS). 

22.3 Are the specific and operational objectives of the Agency still 
relevant in view of the current and new problems/needs identified?  
22.4 Does the technical pillar of the 4th Railway Package still meet 
the current needs and new problems/needs identified through its: 

• 

Introduction of the dual system for VA and safety 
certification 

•  Creation of the OSS 

•  Harmonised implementation of the ERTMS. 

22.5 Is there a need for new objectives or activities to better reflect 
the new problems/needs? 

108 

 
 
Table 11. Evaluation matrix - EU added value questions 

EQ23. What are the benefits of intervening at EU level and offering a harmonised decision-making at the EU level? In light of the above rationale, what 
evidence is there on actual EU added value having been created, also in terms of order of magnitude of the added value? 

Data sources 

•  Desk research  

•  Analysis of relevant documentation 
such as the Impact assessment 
accompanying the proposals for the 4th 
Railway technical pillar  

as 

representative 

•  Targeted  surveys  with  stakeholders 
bodies, 
such 
standardisation  bodies,  applicants,  EU 
institutions, NSAs, and RISC Member 
State representatives 

•  Targeted interviews 

Operational questions 

Indicators 

23.1 To what extent (e.g. fully, partly, not at all) is EU added value 
seen as a benefit for achieving the following objectives? 

Quantitative indicators relating to the benefits of EU-level 
action through the Agency, including: 

•  Ensured a harmonised safety and interoperability 

framework across the EU  

•  Development of harmonised ERTMS and telematics 

deployment 

•  Helped overcome fragmentation of national frameworks and 

rules 

•  Lead to efficiencies for applicants (reduction in costs and 

duration of VA and safety certification) 

•  Ensured greater cooperation, communication and 

information exchange 

•  Lead to a coordinated approach to monitoring of 

performance and decision-making of NSAs and NoBos  

•  Number of objectives of the Agency, as outlined in 
the provisions of Regulation (EU) 2016/796, where 
EU action is expected to bring significant added 
value / or has brought significant added value to 
date  

•  Number of objectives of the Agency, as outlined in 
the provisions of Regulation (EU) 2016/796, EU 
action is expected to bring at least some added 
value/ or has brought some added value to date 

•  Number of activities of the Agency, as outlined in 

the provisions of Regulation (EU) 2016/796, where 
EU action is not expected to bring added value/ or 
has brought limited or no added value to date. 

•  Promoted innovation and research across the rail sector.  

Qualitative indicators:  

23.2 What are the specific additional benefits arising from EU-level 
action taken by the Agency in terms of the above expected benefits, 
in terms of: 

•  Level of evidence available, indicating that EU-
level action brought specific additional benefits 
beyond what national action could achieve 

•  Effectiveness towards the achievement of the 

objectives/benefit 

•  Efficiency/costs of achieving these objectives.  

•  The extent to which stakeholders agree that EU 

intervention as a result of the Agency has increased 
the effectiveness and efficiency of each activity. 

23.3 Are there other benefits that have arisen as a result of action at 
EU level?  

23.4 How would Member State action alone have contributed 
towards addressing the underlying problems to date, namely: 

•  Long and costly authorisation and certification procedures 

Quantitative assessment which draws upon the baseline 
description, and the expected action at the Member State 
level without EU intervention, in particular: 

109 

 
  
 
 
Operational questions 

Indicators 

Data sources 

•  Discrimination against new entrants (e.g. discriminatory 
access to infrastructure, technical/regulatory barriers) 

•  Authorisation and certification data (e.g. certificates 

issued) 

•  Critical importance of safe and interoperable railway 

•  Costs related to authorisation and certification 

operations 

processes. 

•  Lack of modernisation and innovation. 

23.5 Assuming that none of the measures put forward by the Agency 
were adopted, what could be expected to be the situation to date in 
regard to: 

Qualitative assessment of the expected level of action taken 
by Member States to facilitate a harmonised approach to VA 
and ERTMS deployment, and enhance interoperability and 
rail safety across the EU, drawing upon stakeholder views. 

•  The development of national-level measures to facilitate 

improvements in interoperability and safety 

•  Progress made in supporting the implementation of the 

ERTMS and telematics system 

•  The development of non-discriminatory national-level 

authorisation procedures.  

Table 12. Evaluation matrix - Coherence questions 

EQ25. To what extent is the Agency’s mandate coherent with the other interventions to complete the creation of the SERA and EU rail policy in general? To 
what extent is the dual system for VA and safety certification (i.e. with both the Agency and NSAs issuing certificates and licences), the OSS and harmonised 
implementation of ERTMS coherent with the other interventions to complete the creation of the SERA? 

Operational questions 

Indicators 

Data sources 

25.1 Are the overall objectives and mandate of the Agency 
consistent with EU rail policy, in relation to: 

•  Opening the rail transport market to competition 

• 

Improving the interoperability and safety of national 
networks 

•  Developing rail transport infrastructure. 

25.2 Are the specific objectives, operational objectives and activities 
of the Agency consistent with the other interventions to complete the 

Qualitative assessment to determine:  

•  Desk research 

•  The consistency of the purpose, ambition and scope 
of the Agency’s mandate and objectives with the 
objectives and procedures of the market pillar and 
Action plan to boost long-distance and cross-border 
passenger rail services and the TEN-T proposal 

•  The consistency of the dual system for VA and 
safety certification, the OSS and harmonised 
implementation of ERTMS with the objectives of 

•  Analysis of relevant documents such 
as key legislative texts and policy 
documents, ERA SPDs  
•  Targeted consultation with 

stakeholders such as EU institutions, 
representative bodies, civil society 

•  OPC. 

110 

 
 
 
 
Operational questions 

Indicators 

Data sources 

the Action plan to boost long-distance and cross-
border passenger rail services and the TEN-T 
proposal. 

Qualitative assessment to determine:  

•  Desk research 

•  Level of consistency of the purpose, ambition and 

scope of the Agency’s mandate and objectives with 
the objectives of the Green Deal and EU-level 
ambition towards smart and sustainable transport. 

•  Presence of consistency of the Agency objectives 

activities with the UN SDGs.  

•  Analysis of relevant documents such 
as key legislative texts and policy 
documents, ERA SPDs  
•  Targeted consultation with 

stakeholders such as EU institutions, 
representative bodies, civil society 

•  OPC. 

creation of the SERA, including the market pilla’ of the 4th Railway 
Package, specifically in relation to: 

•  Cross-border agreements  

•  Obligations of infrastructure managers to report to RINF 

and input in other databases 

•  Liberalisation of cross-border operations. 

25.3 Are the objectives of the Agency in line with those of the Green 
Deal, e.g. in relation to: 

•  Addressing transport-relating GHG emissions 

•  Encouraging multimodal transport 

•  Supporting the role of automated and connected mobility 

• 

Improving the pricing of transport, to capture external costs 

•  Enhancing the production and deployment of sustainable 

alternative transport fuels 

•  Addressing transport-related congestion and air pollution, 

particularly in cities. 

25.4 Are the Agency’s objectives in line with the Commission’s 
ambitions in the SSMS, e.g. in relation to: 

•  Boosting low-carbon fuels and related infrastructure 

•  Making interurban and urban mobility more sustainable and 

healthier 

•  Greening freight transport 

•  Making connected and automated multimodal mobility a 

reality 

• 

Innovation, data and AI for smart mobility 

•  Reinforcing the single market 

•  Making mobility fair and just for all 

•  Enhancing transport safety and security. 

111 

 
 
 
Operational questions 

Indicators 

Data sources 

•  Desk research 

•  Analysis of relevant documents such 
as key legislative texts and policy 
documents, ERA SPDs  
•  Targeted consultation with 

stakeholders such as EU institutions, 
representative bodies, civil society 

•  OPC. 

25.5 Are there any contradictions between the Agency’s objectives 
and the objectives of the Green Deal and ambitions towards smart 
and sustainable transport? 

25.6 Are the Agency’s activities and objectives coherent with the 
UN sustainable Development Goals?  

25.7 Are there any contradictions/conflicts or overlaps among the 
different functions/units of the Agency, in terms of: 

Qualitative indicators aiming to determine the 
existence/significance of internal inconsistencies: 

•  Priorities and activities 

•  Resource allocation. 

25.8 Are there any contradictions/conflicts or overlaps in the 
provisions, structures/mechanisms and activities of the Agency, 
related to each of the following:  

•  The dual system for vehicle authorisation and safety 

certification; 

•  The operation of the OSS; 

•  The harmonised implementation of ERTMS. 

25.9 Do any of the above contradictions and overlaps affect the 
achievement of the Agency’s objectives including: 

•  Ensured a harmonised safety and interoperability 

framework across the EU;  

•  Development of harmonised ERTMS and telematics 

deployment; 

•  Helped overcome fragmentation of national frameworks 

and rules; 

•  Led to efficiencies for applicants (reduction in costs and 

duration of VA and safety certification); 

•  Ensured greater cooperation, communication and 

information exchange; 

•  Led to a coordinated approach to monitoring of 

performance and decision-making of NSAs and NoBos; 

•  The presence and importance of overlaps, 

contradictions and inconsistencies between the 
roles/activities of the Agency.  

•  The impact of any existing overlaps, contradictions 
and inconsistencies on the achievement of the 
Agency’s objectives.  

112 

 
 
Operational questions 

Indicators 

Data sources 

•  Promoted innovation and research across the rail sector. 

113 

 
 
ANNEX IV. OVERVIEW OF BENEFITS AND COSTS [AND, WHERE RELEVANT, TABLE ON SIMPLIFICATION AND BURDEN REDUCTION] 

TABLE 1. Overview of costs and benefits identified in the evaluation 

Citizens/Consumers  

Businesses (railways sector) 

National Safety Authorities 

ERA  

Quantitative  

Comment 

Quantitative  

Comment 

Quantitative 

Comment  

Quantitative 

Comment 

Direct compliance costs (adjustment costs, administrative costs, regulatory charges) 

Cost description: 

Administrative cost: vehicle 
authorisation costs – average, 
including all fees and 
administrative costs  

Recurrent 

- 

- 

Administrative cost: vehicle 
authorisation costs – first/new 
authorisations for wagons  

Recurrent 

- 

Administrative cost: vehicle 
authorisation costs – 
authorisations in conformity 
to type   

Recurrent 

- 

- 

- 

- 

Below EUR 
110,000 per 
authorisation, 
with costs of 
less than EUR 
10,000 the most 
common value. 
However, costs 
of more than 
EUR 250,000 
per authorisation 
were also 
reported.  

Costs of around  
EUR 8,000 per 
authorisation 

Quantitative 
estimates not 
available 

Labour costs 
for National 
Safety 
Authorities 
related to the 
authorisation 
procedure  

Quantitative 
estimates not 
available 

Labour costs 
for ERA 
related to the 
authorisation 
procedure   

Quantitative 
estimates not 
available 

Labour costs 
for National 
Safety 
Authorities 
related to the 
authorisation 
procedure 

Labour costs 
for National 
Safety 
Authorities 
related to the 
authorisation 
procedure 

Quantitative 
estimates not 
available 

Quantitative 
estimates not 
available 

Labour costs 
for ERA 
related to the 
authorisation 
procedure 

Labour costs 
for ERA 
related to the 
authorisation 
procedure 

Costs of around 
EUR 2,000 per 
authorisation  

Quantitative 
estimates not 
available 

114 

 
                        
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
Administrative costs: safety 
certification  

Recurrent 

- 

Administrative costs: 
ERTMS trackside approval 

Recurrent 

- 

One-Stop shop (OSS) 

Recurrent 

- 

- 

- 

- 

Less than EUR 
100,000 with the 
majority 
indicating costs 
in the range of 
EUR 10,000 to 
60,000  

Quantitative 
estimates not 
available  

Quantitative 
estimates not 
available 

Quantitative 
estimates not 
available 

Labour costs 
for National 
Safety 
Authorities 
related to the 
safety 
certification 
procedure 

Labour costs 
for National 
Safety 
Authorities 
related to the 
trackside 
approval 

Quantitative 
estimates not 
available 

Quantitative 
estimates not 
available 

Quantitative 
estimates not 
available 

Quantitative 
estimates not 
available 

Labour costs 
for ERA 
related to the 
safety 
certification 
procedure 

Labour costs 
for ERA 
related to the 
trackside 
approval 

In 2024 0.5 
million and 
1.5 FTE 
(i.e., 
equivalent of 
EUR 190 
000). 

Labour costs 
for ERA for 
development 
and 
maintenance 
of OSS 

Recurrent 

Cost reduction for 
authorisation/certification 
following harmonisation 
through TSIs and CSMs and 
the elimination of national 
rules.  

Benefit description: 

Quantitative 
estimates not 
available 

Quantitative 
estimates not 
available 

Quantitative 
estimates not 
available 

115 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Report any simplification, burden reduction and cost savings achieved already by the intervention evaluated, including the points of comparison/ where available (e.g. REFIT 
savings predicted in the IA or other sources).  

TABLE 2:  Simplification and burden reduction (savings already achieved)  

Citizens/Consumers 

Businesses (railways sector) 

National Safety Authorities 

ERA 

Quantitative  

Comment 

Quantitative  

Comment 

Quantitative  Comment  

Quantitative  Comment 

Direct compliance costs (adjustment costs, administrative costs, regulatory charges) 

Type: recurrent 

For all vehicle types (except freight 
wagons) reduction of the average 
time to deliver an authorisation 
compared to the targets, i.e., 22% 
reduction from 24 months baseline 
of authorisation time to 18.7 
months.  

Type: recurrent 

Reduction of the actual number of 
national rules  

Quantitative 
estimates not 
available 

Quantitative 
estimates not 
available 

Quantitative 
estimates not 
available 

Quantitative 
estimates not 
available 

Reduction of 
costs and 
removal/ 
reduction of 
restrictions for 
cross-border 
traffic  

Quantitative 
estimates not 
available 

Quantitative 
estimates not 
available 

PART II: II Potential simplification and burden reduction (savings) 

Description:  Direct compliance costs (adjustment costs, administrative costs, regulatory charges) 

Citizens/Consumers 

Businesses (railways sector) 

National Safety Authorities 

ERA 

Quantitative  

Comment 

Quantitative  

Comment 

Quantitative 

Comment   Quantitative 

Comment 

Type:  recurrent  

Better integration of the different 
EU rail registers such as ERADIS, 
ERATV, and EVR with the One-
Stop Shop. 

- 

- 

Quantitative 
estimates not 
available 

Quantitative 
estimates not 
available 

Quantitative 
estimates 
not available 

116 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX V. STAKEHOLDERS CONSULTATION - SYNOPSIS REPORT  

This stakeholder consultation synopsis report provides a summary of the outcome of the 
stakeholder consultation activities which were carried out as part of the evaluation pursuant 
to Article 82(1) of the ERA Regulation. It provides a basic analysis of the responses of 
stakeholder groups involved in the consultation process and a summary of the main issues 
which they raised. Stakeholder involvement was vital for the evaluation in order to collect 
facts and data, to assess the performance of the Agency, to identify possible issues  and 
draw lessons for possible improvement.  

The consultation strategy was developed from the start of the process in December 2020 
and included as key stakeholders the following groups:  

•  Members of the Agency’s Management Board  

•  Members of the Rail Safety and Interoperability Committee (RISC) 

•  Public authorities (national, regional or local level) 

•  Rail infrastructure managers 

•  Railway undertakings 

•  Rail freight corridors 

•  Shift2Rail Joint Undertaking and its successor Europe’s Rail 

•  Associations representing the EU rail sector 

•  Trade Unions 

Other relevant stakeholders were: 

• 

International organisations, namely Intergovernmental Organisation for International 
Carriage by Rail (OTIF) and Organisation for cooperation between railways (OSJD) 

•  NGOs and interest organisations (consumer/environmental/safety organisations, etc.) 

•  3rd  countries,  namely  Western  Balkan  partner  countries  and  Eastern  Partnership 

countries 

•  Researchers and academia 

• 

Interested citizens 

The stakeholder consultation activities performed included the following:  

•  The Evaluation Roadmap was open for comments between 1 March and 29 March 

202181.  

81 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12619-EU-Agency-for-
Railways-European-Commission-evaluation-of-the-Agencys-work_en  

117 

 
 
 
•  Four  targeted  online  surveys,  aimed  at  NSAs,  Member  State  representatives, 
Applicants/users  of  ERA  services,  and  Railway  sector  representative  bodies.  The 
survey ran from 5 April 2022 to 31 May 2022 and received 256 responses.  

•  Targeted stakeholder interviews were conducted with 42 stakeholders during April 

to July 2022 (including 5 exploratory interviews).   

•  The OPC was open between June 2022 and September 2022. 30 responses and one 

position paper were received.  

Stakeholder consultation tools used 

Table 13 provides an overview of the stakeholder consultation tools used throughout the 
evaluation support study, including which stakeholders were targeted and the intended role 
within the evaluation impact assessment. Further details are provided in Table 14. 

Table 13. Overview of stakeholder consultation tools used 

Activity 

Stakeholders involved 

Role within the support study/input provided  

1. Exploratory 
interviews 

ERA Management Board 
(BE, NL, ES) 

NSAs (EBA (DE)) 

Representative bodies 
from the EU railway 
sector (UNIFE, CER 
(Community of European 
Railway and 
Infrastructure 
Companies)) 

• 

• 

•  Discussion  on  objectives  of 

the 
Agency  and 
the  structures  and 
mechanisms in place – used to inform 
the  intervention  logic  /  evaluation 
matrix 
Initial 
the 
performance/operation of the Agency 
helping to identify relevant topics for 
further analysis  
Identification 
needs/availability 

input 

data 

on 

of 

ERA staff (Executive 
director/ Corporate 
Assurance and 
Performance Unit/ 
Executive Office and 
Communication Unit) 

2. Targeted survey 

NSAs  

Member State 
representatives  

Applicants/users of ERA 
services 

Railway sector 
representative bodies  

3. Targeted 
interviews 

All stakeholder groups 

118 

•  Development 

stakeholder 
of 
consultation tools (survey, interviews) 

including 

questions, 

Online surveys gathering inputs to support 
the qualitative and quantitative analysis of 
evaluation 
the 
effectiveness of ERA’s activities, the time 
spent  and  cost  of 
the  authorisation 
/certification and approval processes under 
the 4th Railway Package and the other ERA 
activities 
rules, 
technical  support).  Also  understanding  of 
relevance, coherence and EU  added  value 
of ERA’s operations. 

(monitoring,  national 

Interviews  used 
to  crosscheck  and 
complement the information from the desk 
research and the targeted surveys including 
further 
and 
quantitative  analysis  of  ERA’s  operations 
(including in terms of impacts of costs/time 
from the use of the dual system). Explore 

into  qualitative 

inputs 

 
Activity 

Stakeholders involved 

Role within the support study/input provided  

impact  of 

the  ERA  management 
the 
structure  and  procedures  and  interaction/ 
cooperation  with  other  actors;  practical 
experience  with  use  of 
the  OSS; 
effectiveness  and  efficiency  of  ERA 
operations,  relevance  and  coherence  of 
ERA’s  objectives  and  activities,  and  EU 
added value. 

They  have  also  been  used  to  obtain  input 
from other stakeholders (e.g. trade unions, 
candidate 
representatives, 
international organisations) not covered by 
the survey.  

country 

Information requests to collect specific 
information from ERA staff (a first such 
request has already been submitted) and if 
needed, EU institutions, NSAs and 
applicants also.  

Ad  hoc  requests  to  enable  filling  of 
identified data gaps that emerge after desk 
research and other field research activities; 
requesting 
information/ 
additional 
clarifications;  or  as  a  means  to  improve 
targeted 
balance 
geographical 
consultation 
deemed 
respondents 
necessary. 

of 
if 

Over  10  requests  for  further  information 
were sent to the railway sector respondents 
of the survey to get further clarity on their 
answers.  Additionally,  the  Agency  was 
contacted for additional requests for input 
on several occasions.   

further 

the 
Obtain 
assumptions  and  analysis  and  present 
findings and conclusions 

inputs,  validate 

4. Ad hoc data 
requests 

All stakeholder groups 
(where appropriate) 

5. Presentations to 
RISC 

NSA 

Member State 
representatives of the 
RISC82 

Key experts from the 
railway sector 
representative bodies 

6. Consultation 
activities carried out 
by the EC  

OPC and the feedback to 
the evaluation and fitness 
check roadmap 

Quantitative  and  qualitative  analysis  of 
impacts 

82 Railway interoperability and safety committee.  

119 

 
 
 
Evaluation roadmap 

A total of 10 contributions were received on the Evaluation roadmap. Industry respondents 
(from ‘company/business organisations’ and ‘business associations’) contributed just over 
half of the submissions (2 and 4 respectively), with the remaining responses spread over 
several different stakeholder categories i.e., one EU citizen, one NGO and two ‘other’.  

By country of origin, there were 6 respondents from Belgium, two from Spain, one from 
Norway and one from the Netherlands.  

Key findings from the roadmap 

There  were  several  general  comments  in  support  of  the  proposed  initiative,  which 
underlined the need to evaluate the work of the EU Agency for Railways. All stakeholders 
agreed with the approach and recognised the significance of this EC initiative.  

their  perspective,  companies/business  associations 

From 
(Zeleros  Hyperloop, 
HyperloopTT83,  CER,  UNIFE84,  EIM85  and  NSA  Norway86)  appreciate  and  strongly 
supported both  the evaluation as such as  well as  the Agency in  the improvement of its 
working practices.  

Other stakeholder types were also supportive of this initiative. NSA Norway believes the 
roadmap on the evaluation of the work of the EU Agency for Railways overall covers the 
necessary  points.  EDF87  considers  the  ERA  working  party  tasked  with  reviewing  and 
amending  the  TSI-PRM  very  useful  for  implementing  the  Regulation  to  advance 
accessibility of rail infrastructure and rolling stock for persons with disabilities. Oficina 
española del Corredor Mediterraneo88 highlighted that the achievement of a SERA is an 
ambitious  and  necessary  objective  to  increase  the  presence  of  the  train  in  passenger 
mobility  and  freight  transport  in  Europe,  interoperability  being  the  vector  that  allows 
achieving this objective. 

Targeted Consultation Activities  

Targeted Online Surveys 

A total of 256 survey responses were received. Table 14 provides an overview of the survey 
responses received by stakeholder type.  

Table 14. Survey responses received by stakeholder type 

Stakeholder group 

Number of responses 

NSAs 

Member  State 
authorities 

competent 
(including 

14 

17 

Stakeholders covered 
BE, DE, EE, FI, FR, HR, IE, IT, LT, LU, 
NL, SK, 
Other: CH, NO 

BE, DE, DK, EE, EL, ES, FI, FR, IE, LT, 
LU, PL, PT, SE, SK, SL, 
Other: NO 

83 Hyperloop technology development companies 
84 Association representing the European Rail Supply industry 
85 The European Railway Infrastructure Managers – representing European railway infrastructure managers 
86 Representing national safety authority in Norway 
87 European Disability Forum - Representing persons with disability  
88 Organisation representing companies/social groups in Valencia (ES) lobbying a rail corridor for freight.  

120 

 
 
Stakeholder group 

Number of responses 

Stakeholders covered 

ministries of transport or other 
transport agencies)89 
Industry 
representatives 

/  Railway  sector 

Railway 
businesses 
(applicants  for  VA,  SSC  or 
ERTMS 
trackside  approval 
registered  in  ERA  One  Stop 
Shop)90 

9 

215 

FEDECRAIL; NB-Rail; UNIFE; ACRI; 
AERRL; ANIE ASSIFER; EIM; CER; UIP 
Rail 

• 

• 

• 

• 

railway undertakings (112) 

or 

vehicle 

equipment 
rail 
manufacturers/suppliers 
its 
(or 
authorised representative) (60) 

rail 

rail infrastructure managers (11). 

60 
railway  businesses  described 
themselves  as  ‘other’.  This  group 
included  wagon  keepers  (11),  NoBos 
(3),  consultancies/advisors  (13)  and 
others. 

TOTAL 

256 

- 

Targeted Interviews 

As part of the study, 47 targeted interviews were conducted. 

Five exploratory interviews were undertaken during the inception phase of the evaluation 
support study (February 2022). See Table 15 for further details.  

Table 15. Exploratory Interviews 

Stakeholder 

Stakeholder group 

Executive Board members (BE, NL, ES)  

ERA Executive/ Management Board -Chairs 

ERA Staff  

•  Executive Director 

•  Executive Officer 

•  Financial and Procurement Unit 

•  Planning and Approvals Delivery Unit 
Eisenbahn Bundesamt (EBA) - Germany 

ERA  

NSAs 

CER 

UNIFE 

Representative bodies and associations from 
the railway sector acting at Union level 

Representative bodies and associations from 
the railway sector acting at Union level 

Table 16 provides an overview of the total number of targeted interviews planned and 
subsequently achieved by stakeholder type.   

Table 16. Total number of interviews by stakeholder type 
Stakeholder 
Stakeholder group 
sub-group 

Number of 
interviews 

Stakeholders interviewed 

EU institutions and 
other public bodies  

EU bodies 

1 

•  DG NEAR 

89 In the presentation of the responses the term “National authorities” refers to the Member States competent 
authorities, and NSAs to refer to National Safety Authorities.  
90 In the presentation of the responses to the survey the term railway businesses refers to all applicants. Where 
relevant, the presentation differentiates by type.  

121 

 
 
 
 
Stakeholder group 

Stakeholder 
sub-group 

Number of 
interviews 

Stakeholders interviewed 

1 

•  Europe's Rail Joint Undertaking 

European 
public-private 
partnerships 
related to rail 

NSAs& NIBs 

NSAs 

6 + 1 
exploratory 

NIBs 

Member State representatives (RISC 
members) 

2 

4 

ERA 

7 + 2 
exploratory 

•  EBA (The German Federal Railway 
Authority) (DE) [Exploratory + joint 
targeted interview along with DE RISC 
members] 

•  Administration des Chemins de fer 
(Luxembourg government Railway 
administration) (LU) 

•  Serbian Directorate of Railways (RS) - 

NSA from Western Balkans 

•  Etablissement pulic de sécurité 

ferroviaire (EPSF) (French Rail Safety 
Authority) (FR) 

•  Finnish Transport and Safety Agency 

(FI) 

•  NSA Belgium (BE) 

•  Safety Investigation Authority (FI) 

•  Comision de Investigacion de Acidentes 
Ferroviarios (CIAF)  Railway Accident 
Investigation Commission) (ES) 

•  Federal Ministry for Digital and 

Transport (DE) [Joint targeted interview 
along with DE NSA members] 

•  Ministry of Transport and 
Communications (LT) 

•  Urząd Transportu Kolejowego (Office of 

Rail Transport) (PL) 

•  Norwegian Ministry of Transport (NO) 

ERA Executive Board / Management Board: 

•  Chairperson (BE); Deputy Chair (NL); 
Management Board Member (ES) 
[Exploratory] 

•  Executive Director; Executive Officer; 
Financial and Procurement Unit; 
Planning and Approvals Delivery Unit 
[Exploratory interview] 

•  Railway Systems Department 

•  Safety and Operations Unit 

•  Railway Interoperability of Vehicles and 

Infrastructure Unit 

•  ERTMS and Telematics Unit 

•  Resources and Support 

•  Planning and Approvals 

•  Analysis and monitoring  

Applicants for VA, safety certification 
and ERTMS trackside approval      

13 

Railway undertakings:  

•  Rail Cargo Carrier - Poland Sp. z o.o. 

122 

 
 
 
Stakeholder group 

Stakeholder 
sub-group 

Number of 
interviews 

Stakeholders interviewed 

•  DB Cargo Italia 

•  NS | Techniek | Kwaliteitsmanagement  

• 

boxXpress.de 

•  DN Systemtechnik GmbH 

•  Rail Force 

•  CENTRAL RAILWAYS, a.s. 

Rail vehicle or rail equipment 
manufacturer/supplier:  

•  NEWAG S.A. 

•  Alstom 

•  Siemens Mobility GmbH 

•  Stadler Deutschland GmbH 

•  Geismar GmbH 

Rail infrastructure manager: 

• 

 National Railway Infrastructure   
Company 

2 
exploratory 

•  CER [Exploratory] 

•  UNIFE [Exploratory] 

•  European Federation of Museum & 
Tourist Railways (FEDECRAIL) 

• 

International Union of Wagon Keepers 
(UIP Rail)  

•  EIM 

• 

Intergovernmental Organisation for 
International Carriage by Rail (OTIF) 

•  Permanent Secretariat of Transport 

Community Treaty (TCT) (for Western 
Balkan partner countries) 

•  NB-Rail  

•  Autonomous Train Drivers’ Unions of 

Europe (ALE) 

•  European Disability Forum (EDF) 

Representative bodies 
and associations from 
the railway sector 
acting at Union level  

Organisations 
representing 
applicants for 
VA, safety 
certification 
and ERTMS 
trackside 
approval 

Organisations 
representing 
transport 
operators and 
the wider 
railways 
supply chain 

3 

International rail sector organisations 

2 

Organisations representing those 
involved in testing and or validation of 
industry of products and subsystems 

Civil society   

Employees, 
trade unions 
and 
professional 
organisations 
active in 
transport 
sector 

Consumers 
with 
disabilities 

1 

2 

123 

 
 
Stakeholder group 

Stakeholder 
sub-group 

Number of 
interviews 

Stakeholders interviewed 

Total 

42 + 5 
exploratory 

Key findings from targeted interviews and online surveys Concerning their practical 
experience with the VA process under the 4th Railway package, both railway businesses 
and NSAs consider that the process still has significant limitations. When asked to compare 
with the previous experience, there are a number of cases where their view is that process 
has not improved or even deteriorated. 

The  responses  provided  by  railway  businesses  and  NSAs  concerning  the  new  safety 
certification process are largely positive. The larger share of railway businesses (46 out 
of  73  that  provided  an  answer)  considered  the  quality  of  the  application  assessment  as 
positive  or  very  positive.  The  majority  (40  out  of  64)  indicated  that  there  has  been  an 
improvement, in contrast to only 7 that considered that the process is not somehow worse. 
NSAs  were  also  positive  concerning  the  harmonisation  of  the  approach.  There  were 
minimal comments regarding the dual system, and those that were provided were largely 
focused  on  how  the  objective  is  not  meeting  the  needs  of  the  railway  sector.  Railway 
businesses had the lowest  level  of overall agreement of the groups  surveyed. The main 
comments were that more work needs to be done to improve the dual system, OSS and 
ERTMS harmonisation across the EU. The main limitation and weakness identified in the 
functionality of the OSS tool includes the increased effort and time needed. 

On the NSAs monitoring, the opinion of NSAs and national competent authorities was 
generally positive, with positive feedback given by 10 out of the 12 NSAs that provided a 
view.  The  comments  highlighted  how  ERA’s  monitoring  activity  stimulates  the 
improvement of NSAs’ activity. Some respondents, however, added that the real impact 
of  the  initiative  will  manifest  itself  in  the  years  to  come.  Only  2  NSAs  and  2  national 
authorities said their experience was negative.  

Only two NSAs, two national authorities, and one railway sector representative provided 
an  answer  to  the  question  on  NoBos  monitoring.  Overall,  the  NSAs  and  national 
authorities  were  mostly  positive  on  the  effectiveness  of  the  Agency’s  monitoring  of 
NoBos. 

Stakeholders provided a mixed view on the activities of the Agency related to the review 
of existing and new national rules. NSAs had a mixed opinion on the effectiveness of 
ERA’s  assessment  of  national  rules  and  the  identification  of  redundant  ones.  Railway 
sector representatives agreed that reducing national rules has resulted in cost savings and 
expressed a desire for speeding up the cleanup of the remaining rules. 

Stakeholders identified the main strength of the process as the possibility offered by this 
process to ensure transparency of national rules. Stakeholders also expressed a desire for 
speeding up the clean-up of the remaining rules, which are often the most controversial. 
The  other  stakeholders  signalled  the  following  negative  impacts:  creation  of  gaps  in 

124 

 
 
 
legislation, i.e. areas no longer covered by national rules but not adequately covered by EU 
legislation. 

Since the adoption of the 4th Railway Package, ERA is in a process of developing and 
adapting its registers and databases to fulfil its new activities and responsibilities.  

A significant share of rail sector representatives did not consider most registers as being 
user friendly. The view of NSAs is relatively more negative than that of the rail industry. 
Stakeholders  also  answered  a  question  on  whether  appropriate  guidance  and  support 
available for registers and IT tools. Most stakeholders across all groups agreed or had a 
neutral view on this issue. 

There is a balance of positive and negative assessments in relation to the SRD among all 
stakeholder groups. A larger proportion of NSAs disagreed with ERADIS being an easy 
tool to use (4 out of 13). Like rail sector businesses, NSAs see RINF as the most difficult 
to use. Developed to support authorisation functions by ensuring an integration with OSS, 
ERADIS, ERATV and EVR received an overall positive assessment from rail businesses. 
Representatives of the rail sector expressed a different view, with most of them disagreeing 
with this statement for most registers and IT tools. 

According  to  the  ERA  Regulation,  the  Agency  is  responsible  for  providing  the 
Commission with recommendations and opinions. 6 out of 14 NSAs and all industry 
rail  representatives  (10  out  of  10)  provided  positive  input  on  the  opinions  issued 
concerning  both  safety-  and  interoperability-related  aspects.  NSAs  and  railway  sector 
representatives  also  commented  on  the  extent  the  working  groups  are  appropriate  to 
achieve integration of change requests and innovative solutions. 

More  positive  feedback  was  provided  for  the  reports  on  the  progress  on  the  safety  and 
interoperability  of  the  EU  rail  system.  Most  NSAs  (12  out  of  14)  and  all  industry  rail 
representatives (10 out of 10) provided a positive assessment (good or very good).  

ERA is expected to promote European experiences, regulations and standards to third 
parties.  This  includes  Western  Balkans  states  and  Turkey  mainly  in  the  context  of  the 
implementation and with the use of funds of the European Union’s IPA, ERA staff liaise 
with authorities of non-EU member states, and they promote the EU approach for railways. 

ERA  successfully  delivered  of  workshops  and  training  of  national  experts,  and  other 
related support was provided. The TCT expressed that ERA supports all TCT rail. They 
expect  the  Agency  to  carry  on  doing  this  type  of  events  in  the  future,  as  their  delivery 
slowed down during the COVID pandemic. ERA organised two bilateral meetings with 
Macedonia  and  Albania,  as  part  of  a  TCT  initiative.  Further,  ERA  has  achieved  good 
outcomes in terms of the activities and services it had to provide under the IPA program. 

Insights  to  the  role  and  performance  of  the  Agency  in  terms  of  their  direct  role  as  rail 
innovation promoter provided by selected stakeholders suggest that ERA has made great 
contributions to the development and uptake of innovation in the railways sector. The main 
issue identified was related to the insufficient time/resources of the Agency for these tasks. 

All  stakeholders  were  asked to  comment  on  the extent to which the objectives of the 
Agency are still relevant to the current problems and needs of the railway sector. NSAs 

125 

 
showed  greater  disagreement  with  the  objectives  of  reducing  the  time  to  market  of 
innovation  and  reducing  administrative  costs.  All  other  stakeholder  groups  generally 
agreed that all objectives are still relevant. National authorities showed the highest level of 
agreement (14 out of 15) followed closely by railway sector representatives with 8 out of 
9 and NSAs with 11 out of 13. Railway businesses also had a majority agreeing that the 
objective is still relevant (130 out of 198). The majority of respondents seemed to agree 
that the issues identified at the time of adoption of the 4th Railway Package are still present. 

In  terms  of  the  clarity  of  the  VA  and  safety  certification  processes,  a  large  share  of 
railway  businesses  (36  out  of  73  that  provided  an  answer)  provided  a  positive  or  very 
positive assessment. Still, 24 made a negative or very negative assessment. Almost half 
(32  out  of  65  that  provided  a  view)  considered  that  there  has  been  an  improvement 
compared the previous situation. 

Railway businesses and NSAs were satisfied with the level of information available on 
the OSS platform on the approval process. Most railway businesses (applicants) were 
satisfied or very satisfied with  their ability to  apply  in  the preferred language.  Railway 
businesses articulated that the benefits that many experienced through the harmonised OSS 
approach  are  counter-acted  by  the  increased  effort  required.  Businesses  call  for  better 
interconnection between all the relevant  ERA tools  to  reduce the administrative burden 
and automate parts of the assessment. 

37 out of 72 railway businesses that provided an answer gave a very negative or negative 
assessment  concerning  the  predictability  of  the  fees,  while  27  provided  a  positive 
assessment. Most NSAs provided a moderate assessment (6 out of 12), with 4 providing a 
positive assessment and 2 a negative. Only a small share indicated that they have used the 
pre-engagement process. 

Cost savings for the applicants were expected both with the reduced costs linked to the 
application process as well as with opportunity costs savings from the time that vehicles 
may remain idle in workshops while being approved. In contrast, an increase in costs and 
time needed for authorisation and certification activities has been reported. 

Ten  railway  businesses  pointed  to  the  increasing  documentation  requirements  of  the 
authorisation process through the OSS for the cause of greater time burden. More human 
resources have been required to prepare and process these documents, leading to greater 
costs. The key reason for cost increases is the need for CTT whose series had already been 
authorised. 

The  shortest  and  lowest  cost  applications  are  for  first  wagon  authorisations.  The  most 
expensive are multiple unit passenger trains (EUR 500 000). Most rail businesses reported 
needing up to 2 FTE for the development and submission of applications. 

Most  businesses  gave  average  total  cost  values  less  than  EUR  100  000.  One  applicant 
clarified  that  20%  of  their  total  average  costs  were  associated  with  preparation  and 
submission of information.  

Concerning  the  costs  for  the  NSAs,  those  were  asked  to  state  how  their  annual  costs 
associated with authorisation activities had changed since the adoption of the 4th Railway 
Package. The majority of NSAs said that their costs had not changed (9 out of 12). One 

126 

 
NSA  reflected  that  some  costs  have  fallen  as  ERA  has  taken  over  some  aspects  as  the 
authorizing body. 

Both authorities and railway sector representatives provided a negative assessment of the 
Agency success in  reducing  the  costs and direction of VA process.  Most  NSAs had a 
negative or very negative view concerning the delivery in this area. National authorities 
were  in  relative  terms  more  positive  but  still  largely  sceptical.  The  majority  of  railway 
sector businesses considered that ERA activities so far have not contributed to reducing 
costs and duration of authorisation. 

Stakeholders (including national authorities and railway sector representatives) were also 
asked to provide an assessment of the effectiveness of ERA in its role. National authorities 
appeared quite positive, with 3 out of 17 respondents indicating that ERA was somehow 
effective  in  its  role  concerning  authorisation  and  certification.  Only  4  out  of  9  railway 
sector representatives provided input in  this area. The dominant  issue is  the  impact on 
costs/resources  and  time  for  the  vehicle  authorisation  process  as  a  result  of  the 
implementation of the 4th Railway Package. 

The 2013 IA that supported the adoption of the 4th Railway package discussed the expected 
added value of EU level action. According to the assessment, action by Member States 
alone  could  not  ensure  the  coherence  of  the  EU  railway  market  and  address  divergent 
interpretation of the legislation. Action at EU level was considered important as it would 
to ensure consistent implementation. 

Stakeholders  (including  NSAs,  national  authorities  and  railway  sector  representatives) 
were also asked to comment whether action at  Member States level only would deliver 
results in different impact areas.  

Two NSAs stated in interviews that Member State level action could already address the 
long and costly certification and authorisation procedures alone. Views were mixed with 
regard  to  whether  Member  States  can  address  the  continued  need  to  ensure  safe  and 
interoperable railway operations across the EU. 

The railway sector representatives UNIFE, ACRI and ANIE ASSIFER  highlighted that 
ERA action at EU level brings forward harmonisation and standardisation within the EU. 
The Member States that consider that action at national level alone could deliver in these 
areas tend to be from Western European. The ones that consider added value in action at 
EU level are rather from Eastern Europe. 

Most respondents supported EU level action when looking at the elimination of redundant 
national  rules.  One  NSA  added  that  EU  level  activities  that  decrease  barriers  such  as 
reducing national rules bring significant added value.  

Most stakeholders were in favour of EU level action with regards to ensuring a coordinated 
approach to monitoring of performance and decision-making of NSAs. In their view action 
at  Member  State  level  alone  is  not  sufficient  in  delivering  this.  9  out  of  the  13  NSA 
respondents stated that Member State action alone could only deliver to a limited extent or 
not at all. 

127 

 
Stakeholder views were mixed with regards to  reducing costs and the duration of the 
VA and safety certification processes. Stakeholders (including NSAs, national authorities 
and railway sector representatives) were asked to comment on the different parameters 
and mechanisms in the performance of the Agency. The parameters that are considered 
by the majority of stakeholder groups to have had an impact on the Agency’s performance 
include human and financial resources. Resource availability has been identified as a 
problematic  aspect  affecting  the  effective  delivery  of  the  Agency’s  roles  and 
responsibilities.  

NSAs and national authorities’ views were equally split when it comes to the sufficiency 
of resources for the monitoring of NSAs and NoBos. Most railway sector representatives 
did not have a view.  

Most stakeholders did not have a view concerning the role of the Agency’s management 
and  organisations  structures.  Among  those  few  that  contributed  (whether  NSAs, 
authorities  or  railway  sector  representatives),  the  feedback  provided  was  in  most  cases 
positive. One common comment made was the ongoing inability to resolve the language 
issue faced by the Agency. 

The performance of NSAs and the cooperation between the Agency and the NSAs also 
received a positive assessment. However, comments concerning the cooperation with the 
NSAs also suggested that this is sometimes (i.e. in relation to specific NSAs) challenging. 

Stakeholders were asked to respond to the question on the effectiveness of cooperation 
between the Agency and the railway sector and the input provided by the stakeholders 
does not point to a strong positive role of the cooperation with the NSAs. At the same time, 
most stakeholders that responded considered that the cooperation contributed at least to 
some extent. This is particularly in relation to the authority related activities. 

Open Public Consultation  

The OPC was open from 10 June 2022 to 2 September 2022, and a total of 30 responses 
were received.  

Table 17 presents the number of stakeholders that completed the OPC, split by stakeholder 
group. 

Table 17. Classification and number of stakeholders responding to the OPC 

Stakeholder group 

High level grouping 

Number of responses 

Business association 

Company/business organisation 

Public authority 

EU citizen 

Non-EU citizen 

Academic/research institution 

Consumer organisation 

7 

10 

4 

2 

1 

2 

0 

Industry 

Industry 

Public authority 

Citizen 

Citizen 

Other 

Other 

128 

 
Environmental organisation 

Non-governmental organisation (NGO) 

Other 

Other 

Other 

Other 

- 

2 

2 

The geographical distribution of the respondents is the following: Belgium (8), Czechia 
(7),  France  (6),  Spain  (3),  Germany  (2),  the  Netherlands  (1),  Poland  (1),  Norway  (1), 
Switzerland (1).  

Key findings from the OPC 

25 out of 30 respondents indicated that the current Agency’s mandate is (at least to some 
extent) adequate for achieving a well-functioning SERA. Three indicated that it is very 
adequate, 10 indicated is adequate and 12 adequate to a limited extent.  

Where  it  was  indicated  that  the  Agency’s  mandate  was  only  adequate  to  a  limited 
extent, respondents provided a number of reasons that were not necessarily addressing 
the adequacy of ERA mandate but referred more to the limitations of ERA in delivering 
its mandate. More specifically, there was reference to: The mandate of ERA to achieve 
SERA  should  consider  the  increasing  digitalisation  of  rail  operations  and  the  new 
related areas that needs to be covered in terms of interoperability (1 EEA citizen, 1 
railway  sector  business/association).  However,  the  budgetary  constraints/limited 
resources  of  ERA  make  it  difficult  to  deliver  its  mandate  (1  railway  sector 
business/association, 1 national authority). 
It  would  be  beneficial  for  the  sector  to  extend  the  Agency’s  mandate  to  full 
responsibility  for  a)  national  rules  cleaning  and  reduction  and  b)  the  ERATV 
management (1 railway sector business/association) 

• 

•  The inconsistency in the approach to similar cases/lack of specific country awareness 

(1 national authority, 2 railway sector business/association) 

•  The mandate being unnecessarily extensive (1 railway sector business/association) 

• 

 The Agency's mandate is not yet sufficient to fully achieve its objectives. It is currently 
still heavily dependent on the European Commission and NSAs (1national authority). 

22 out of 30 respondents indicated that ERA had contributed to higher safety levels. Four 
indicated that ERA contributed here to only to a small extent and one not at all.  

Thirteen contributors considered that the objectives and tasks of the Agency are sufficient 
to deliver the necessary modernisation of the Union’s rail sector within the next 5-10 years. 
Of those who explained their answers, reasons cited as to why these tasks and goals are 
not considered to be sufficient included:  

•  Lack of means and resources from ERA to lead to this result (1 national authority) 

•  Lack of consideration from the Agency to the operating conditions of rail transport in 

its entirety (1 civic society) and  

•  ERA’s  lack  of  control  over  Shift2Rail/Europe’s  Rail  Joint  Undertaking  (1  railway 
sector business/association, 1 non-railway business, 1 civic society organisation).   

129 

 
The contributors consider the development of TSI as the most powerful to trigger change 
in  the  rail  sector,  followed  by  the  cleaning  up  of  national  rules  and  the  harmonized 
implementation of ERTMS.  

Concerning  digitalisation  and  innovation,  the  views  among  the  14  respondents  were 
diverging, some respondents had positive views, while other considered there had not been 
enough progress.   

Ten out of 30 contributors either agreed or strongly agreed that the introduction of the dual 
system for VA and safety certification met the needs of the rail sector. Nine respondents 
indicated that there are inconsistencies or overlaps in the functioning of the dual system, 
while one national authority identified no flaws. 

Less than half of the respondents (13 out of 30) indicated that the Agency’s role in the VA 
and safety certification is sufficient.  

21 out of 30 respondents indicated that they had observed negative consequences of the 
enhanced Agency’s mandate. Among these, the most cited negative consequences were: 

• 

• 

• 

Increase in direct costs (fees) and indirect costs (legal and technical advice) (1 national 
authority, 4 civic society, 3 railway sector business/associations) 

Increased  complexity  of  procedures  and  administrative  burden  (2  civic  society,  5 
railway sector business/associations) 

Increased  number  of  participants  to  be  consulted  in  order  to  reach  agreements  (1 
national authority) 

•  Lack of sufficient human resources in the Agency to tackle the new tasks (1 railway 

sector business/association). 

130