COMMISSION STAFF WORKING DOCUMENT Progress report on the implementation of the Railway Safety Directive Accompanying the document Communication from the Commission to the Council and the European Parliament on a progress report on the implementation of the Railway Safety Directive
Date: 2014-12-17
Institutions: European Commission
Subjects: EU law - national law, European Union Agency for Railways, national implementing measure, rail transport, safety standard, single market, transport safety

EUROPEAN 
COMMISSION 

Brussels, 17.12.2014  
SWD(2014) 355 final 

COMMISSION STAFF WORKING DOCUMENT 

Progress report on the implementation of the Railway Safety Directive 

Accompanying the document 

Communication from the Commission to the Council and the European Parliament 

on a progress report on the implementation of the Railway Safety Directive 

{COM(2014) 740 final} 

EN 

   EN 

 
 
 
 
  
 
COMMISSION STAFF WORKING DOCUMENT 

Progress report on the implementation of the Railway Safety Directive 

Accompanying the document 

Communication from the Commission to the Council and the European Parliament 

on a progress report on the implementation of the Railway Safety Directive 

Table of Contents 

1.  

INTRODUCTION....................................................................................................................... 3 

1.1. 

Institutional set-up of the railway safety ................................................................................. 3 

2.  

DEVELOPMENT OF THE LEGAL FRAMEWORK................................................................ 5 

2.1. 

EU policy developments in the railway field and in rail safety in particular .......................... 5 

2.2. 

Last development of the legal framework for rail safety......................................................... 7 

2.2.1.   Common safety indicators (Article 5 of the Railway Safety Directive).......................... 7 

2.2.2.   Common safety methods (Article 6 of the Railway Safety Directive)............................ 7 

2.2.3.   Common safety targets (Article 7 of the Railway Safety Directive)............................. 10 

2.2.4.   Certification of the entities in charge of maintenance for freight wagons   (Article 14a 
of the Railway Safety Directive) ................................................................................................... 12 

2.3.   National safety rules.............................................................................................................. 12 

2.3.1.  

The Task Force on national safety rules and the rule management tool ....................... 12 

2.3.2.   Notif-IT: database of national safety and national technical rules ................................ 13 

2.3.3.  

Follow-up of the recommendations of the Task Force.................................................. 13 

2.4.   The 4th Railway package and the recast of the Railway Safety Directive ............................. 15 

2.4.1.   Revision of the Safety Certification and migration towards a single safety certificate. 15 

2.4.2.   A moving environment for safety.................................................................................. 17 

2.4.3.   Recast of the Railway Safety Directive: inter-institutional dialogue ............................ 18 

3. MONITORING THE IMPLEMENTATION AND THE SAFETY PERFORMANCE ................... 19 

3.1.   Measures notified by the Member States for transposition of Directive 2004/49/EC........... 19 

3.2.   Managing and monitoring safety........................................................................................... 20 

3.2.1.  Managing safety ............................................................................................................ 20 

3.2.2.  

Safety certification and Safety authorisation................................................................. 22 

3.2.3.  

Safety overview ............................................................................................................. 23 

2 

 
 
3.2.4.   Occurrences investigated by NIBs ................................................................................ 26 

3.2.5.   Monitoring activities supported by ERA....................................................................... 27 

3.3.   Certification of the entities in charge of maintenance: overview .......................................... 28 

Status of different schemas (ART 10.1 of the Regulation (EU) 445/2011) in EU and 

3.3.1.  
non EU Contracting States. ........................................................................................................... 28 

3.3.2.  

State of play of ECM certification................................................................................. 29 

3.3.3.  

ERA supporting activities.............................................................................................. 30 

3.4.   Further developments ............................................................................................................ 30 

3.4.1.   Monitoring safety performance processes..................................................................... 30 

3.4.2.   A Platform for European Rail Infrastructure Managers (PRIME) ................................ 33 

CONCLUSIONS ................................................................................................................................... 34 

3 

 
 
1.  

INTRODUCTION 

This  report  is  an  update  of  the  state  of  play  of  the  implementation  of  the  Railway  Safety 
Directive  (Directive  2004/49/EC1)  since  the  last  report  SEC  (2009)  1157  issued  on  8 
September 2009. This update is required every 5 years in accordance with Article 31 of the 
aforementioned directive.  

After  a  short  introduction  devoted  to  the  authorities  and  institutional  bodies  created  for  the 
implementation of the Railway Safety Directive, Chapter 2 will present the developments of 
the  legislation  built  on  the  Railway  Safety  Directive  during  the  last  five  years,  while  
Chapter 3 will focus on its implementation and enforcement. 

Most  of  the  legal  documents  referred  in  the  progress  report  are  published  on  the  Official 
Journal of the European Unions. All reports related to railway safety are publicly available on 
the  web  site  of  the  European  Railway  Agency:  http://www.era.europa.eu/Pages/Home.aspx. 
Internal notes related to the correspondence  with  the  Member States in matter of legislative 
procedures and transposition into the national legal framework cannot be disclosed. 

The European Railway Agency is credited for all figures in this report. 

1.1. 

Institutional set-up of the railway safety 

In  2009  the  authorities  and  institutional  bodies  most  relevant  to  the  implementation  of  the 
Railway Safety Directive were already in place: 

•  The Railway Interoperability and Safety Committee (RISC) where Member States are 
represented.  It  was  established  under  Article  21  of  Directive  96/48/EC.  The 
competences  of  the  Committee  have  been  extended  three  times:  in  2001  with  the 
conventional  rail  interoperability directive, in 2004 with the railway safety directive, 
and in 2007 with the train driver certification directive (Directive 2007/59/EC2). 

The  Committee  is  chaired  by  the  Commission  and  has  held  its  70th  meeting  in  June 
2014.  The  agenda  is  prepared  by  the  Commission  and  includes,  as  standard  parts: 
items submitted for vote under comitology procedures, items for discussion and items 
to  agree  on  the  Community  position  for  meetings  organised  by  international 
organisations  such  as  OTIF  and  OSJD.  Since  the  Agency  was  established,  it  has 
reported regularly on the state of play of its work leading to Commission measures. 

•  The European Railway Agency (ERA) was established in 2005 to help the integration 
of  the  railway  area  by  reinforcing  safety  and  interoperability.  Its  objective  is  to 
contribute,  on  technical  matters,  to  the  implementation  of  Community  legislation 

1  Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the 

Community’s railways and amending Council Directive 95/18/EC on the licensing of railway undertakings 
and Directive 2001/14/EC on the allocation of railway infrastructure capacity and the levying of charges for 
the use of railway infrastructure and safety certification (OJ L 164, 30.4.2004, p. 44 and Corrigendum, OJ L 
220, 21.6.2004, p. 16. 

2   Directive 2007/59/EC of the European Parliament and of the Council of 23 October 2007 on the certification 
the  Community,   

train  drivers  operating 

the  railway  system 

locomotives  and 

trains  on 

in 

of 
OJ L315 of 3 December 2007, p. 51. 

4 

 
 
                                                            
aimed at improving the competitive position of the railway sector. Its work involves 
producing recommendations intended to become Commission decisions or regulations 
and  issuing  opinions  on  matters  relating  to  Interoperability  and  safety.  All 
recommendations must be accompanied by an economic analysis. 

•  National  safety  authorities  (NSAs)  assure  safety  performance  whilst  taking  care  that 
safety  regulation  does  not  hinder  market  opening  opportunities  during 
the 
development  of  interoperability.  The  NSAs  are  responsible  for  inspecting  and 
supervising  the  activities  of  the  railway  undertakings  and  infrastructure  managers 
during the period of validity of the safety certificate or safety authorisation. 

•  National investigation bodies (NIBs) are charged with investigating serious accidents 
and – at their discretion – other accidents and incidents on the railway. Supported by 
ERA, they are obliged to exchange views and experiences with each other in order to 
develop  common 
investigation  methods,  principles  for  following  up  safety 
recommendations  in  safety  reports  and  to  adapt  investigations  to  the  latest  technical 
and scientific progress. 

To  complete  this  institutional  framework,  new  institutional  bodies  have  been  introduced  for 
specific tasks during the last five years: 

•  The bodies issuing a certificate for the entities in charge of maintenance. These may 
be  bodies  either  accredited  or  recognised  by  the  Member  States.  Also  the  NSA  can 
issue  such  certificate,  in  particular  when  maintenance  is  performed  by  the  railway 
undertakings  themselves.  Although  these  bodies  was  required  in  Article  14a  of  the 
Railway  Safety  Directive,  they  became  operational  after  the  Regulation  (EU)  No 
445/2011 on a system of certification of the entity in charge of maintenance for freight 
wagons3 entered into force in 2011; 

•  The bodies able to carry out an independent assessment on the application of the risk 
management  process  according  to  Commission  Regulation  (EC)  No  352/2009  of  24 
April 2009 on the common safety method for risk evaluation and assessment4. Their 
competencies  were  further  developed  with  the  Commission  Regulation  (EU)  No 
402/2013  of  30  April  2013  on  the  common  safety  method  for  risk  evaluation  and 
assessment5, which will be applied from May 2015. 

3  
4  
5  

OJ L 122 of 11.5.11, p. 22 

OJ L 108 of 29.4.09, p. 4 

OJ L 121 of 3.5.13, p. 8 

5 

 
                                                            
2.  

DEVELOPMENT OF THE LEGAL FRAMEWORK 

2.1.  EU policy developments in the railway field and in rail safety in particular 

In its White Paper ‘Roadmap to a Single European Transport Area - Towards a competitive 
and  resource  efficient  transport  system’,  adopted  on  28  March  2011,  the  Commission 
announced  its  vision  to  establish  a  Single  European  Railway  Area  and  clarified  that  this 
objective implies creating the internal railway market where European railway undertakings 
can provide services without unnecessary technical and administrative barriers. 

Additionally, the European Council conclusions of January 2012 highlighted the importance 
of  releasing  the  growth-creating  potential  of  a  fully  integrated  Single  Market,  including  as 
regards  network  industries6.  Furthermore,  the  Commission  Communication  on  Action  for 
Stability,  Growth  and  Jobs  adopted  on  30  May  20127  stresses  the  importance  of  reducing 
further the regulatory burden and barriers to entry in the rail sector making country specific 
recommendations in that direction. In the same vein, the Commission adopted on 6 June 2012 
the  Communication  on  strengthening  the  governance  of  the  single  market,  which  likewise 
stresses the importance of the transport sector8. 

A common regulatory framework for railway safety was a necessary cornerstone for a single 
market for rail transport services. Member States have until now developed their safety rules 
and standards mainly on national lines, based on national technical and operational concepts. 
Simultaneously, differences in principles, approach and culture have made it difficult to break 
through the technical barriers and to establish international transport operations. 

The  'Railway  Safety  Directive'  2004/49/EC9,  represented  a  great  improvement  towards  the 
establishment  of  a  common  regulatory  framework  for  railway  safety.  The  Directive 
established  a  framework  for  harmonising  the  content  of  safety  rules,  safety  certification  of 
railway  undertakings,  the  tasks  and  roles  of  the  safety  authorities  and  the  investigation  of 
accidents,  to  discourage  Member  States  from  continuing  to  develop  their  safety  rules  and 
standards based on national technical and operational concepts. 

Directive 2004/49/EC was amended by Directive 2008/57/EC of the European Parliament and 
of the Council of 17 June 200810 and Directive 2008/110/EC of the European Parliament and 
of the Council of 16 December 200811. The last one introduced the concept of 'entity in 
charge of maintenance' (ECM) and the new article 14a set the obligation for each vehicle to 
have an ECM assigned to it. 

The legal framework created by the Railway Safety Directive is based on the principle of role 
and  responsibility  sitting  with  the  two  major  operational  actors  of  the  railway  chain:  the 
railway undertakings and the infrastructure managers.  

6 
7 
8 
9 
10  
11  

http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/ec/127599.pdf. 

COM (2012) 299 final. 

COM(2012) 259 final. 

OJ L 164, 30.4.2004, p. 44. 

OJ L 191, 18.7.2008, p. 1 

OJ L 345, 23.12.2008, p. 62 

6 

 
                                                            
These  actors  have  the  best  opportunity  to  know  and  manage  the  risks  related  to  their 
operations.  Therefore,  they  are  responsible  for  assessing  all  the  risks  related  to  the  safe 
operation  of  the  trains  and  establishing  a  safety  management  system  (SMS)  according  to 
Article 9 of the Directive. The SMS is the main tool for managing safety. It demonstrates the 
maturity  and  competences  of  the  railway  undertaking  and  infrastructure  managers  and 
actually their capability in addressing risks. 

After having evaluated the quality of the respective SMS, the NSAs issue safety certificates to 
the railway undertakings and safety authorisation to the infrastructure managers. Through the 
certification  or  authorisation  systems  these  two  main  players  should  demonstrate  that  they 
have  in  place  an  effective  system  to  manage  safety  and  they  are  able  to  satisfy  the 
requirements for the safe operation on the railway network. 

The  picture  provided  by  the  safety  certificates  and  authorisations  may  be  good  but  only 
partial: supervision, consisting of ongoing verification that SMSs are correctly implemented, 
is  also  an  essential  part  of  the  certification  process.  NSAs  have  an  essential  role  in  issuing 
safety certificates and in performing supervision activities. 

The  SMS  should  also  include  the  process  for  improving  and  taking  the  appropriate  lessons 
after  an  occurrence  (accident  or  incident).  This  consists  of  an  efficient  system  of  internal 
reporting, investigation and analysis for taking the necessary preventive measures. To achieve 
this  goal,  railway  undertakings  and  infrastructure  managers  should  establish,  within  their 
safety  culture,  a  "just  culture"  to  actively  encourage  personnel  to  report  safety-related 
accidents, incidents and near misses without being subject to punishment or discrimination. A 
fair,  not  blaming  culture  enables  the  railway  industry  to  learn  lessons  from  accidents  and 
incidents and thereby improve safety for workers and for passengers. 

The  recommendations  provided  by  the  NIBs  are  another  tool  to  take  lessons  from  the 
accidents.  The  railway  undertakings  and  the  infrastructure  managers  should  take  preventive 
measures the most appropriate to their particular risk profile. The NSAs should abstain from 
setting new safety rules after an accident reducing their margin of manoeuvre unnecessarily. 
They  should  show  leadership  in  best  proactive  benchmarking,  assuring  that  the  railway 
undertakings  and  the  infrastructure  managers  take  their  responsibilities,  and  supervise  that 
appropriate preventive measures are taken, according to the SMS provisions. 

To  conclude,  safe  and  successful  railway  transport  operations,  is  a  common  goal  of  the 
railway undertakings, the infrastructure managers, the NSAs and the NIBs.  

Railway undertakings are not rewarded by doing short-cuts in matter of safety: persistent poor 
safety  records  may  lead  to  poor  competitiveness  and  to  the  revocation  of  their  safety 
certificate.  On  their  side,  the  major  obligations  of  the  NSAs  are  related  to  certification, 
authorisation and supervision, and they should avoid taking the responsibilities that sit  with 
the railway undertaking and the infrastructure managers. 

7 

 
2.2.  Last development of the legal framework for rail safety 

Since  the  adoption  of  the  last  progress  report  in  2009,  the  secondary  legislation  in  railway 
safety  has  been  developed  and  the  implementing  acts  required  by  the  Railway  Safety 
Directive entered into force. 

2.2.1.   Common safety indicators (Article 5 of the Railway Safety Directive) 

Information  on  common  safety  indicators  (CSIs)  is  necessary  to  assess  the  achievements  of 
the  common  safety  targets  (CSTs)  and  to  provide  for  the  monitoring  of  the  general 
development  of  railway  safety  in  the  EU.  In  accordance  with  Article  5(2)  of  Directive 
2004/49/EC, Annex I to that Directive had to be revised to include common definitions of the 
CSIs  and  methods  to  calculate  accident  costs.  The  revision  of  Annex  I  was  carried  out 
according to the regulatory procedure with scrutiny. 

The  amendment  of  Annex  I  was  provided  the  first  time  in  Commission  Directive 
149/2009/EC  of  27  November  2009  amending  Directive  2004/49/EC  of  the  European 
Parliament  and  of  the  Council  as  regards  Common  Safety  Indicators  and  common 
methods to calculate accident costs12. 

This  directive  was  based  on  Recommendation  ERA/REC/SAF/02-2008  delivered  by  the 
European Railway Agency on 29 September 2008, and on an in-depth analysis of the current 
Annex I carried out by ERA. 

After five years of practical experience with reporting and with the use of the indicators, ERA 
suggested  some  further  amendments  to  improve  consistency  in  reporting  of  common  safety 
indicators across the Union. On 10 December 2013, ERA delivered the new Recommendation 
ERA/REC/08/2013  on  the  amendment  of  Annex  I  of  Directive  2004/49/EC.  The  new 
Commission  Directive  2014/88/EU  amending  Directive  2004/49/EC  of  the  European 
Parliament  and  of  the  Council  as  regards  common  safety  indicators  and  common 
methods of calculating accident costs13was adopted on 9 July 2014. 

2.2.2.   Common safety methods (Article 6 of the Railway Safety Directive) 

One  of  the  purposes  of  Directive  2004/49/EC  is  to  improve  access  to  the  market  for  rail 
transport  services  by  defining  common  principles  for  the  management,  regulation  and 
supervision of railway safety. The Directive also provides a framework for equal conditions 
for all infrastructure managers, as the same safety authorisation requirements apply across the 
European Union.  

12  
13  

OJ L313 of 28.11.09, p. 65 

OJ L201 of 10.7.2014, p.9 

8 

 
 
 
                                                            
These  common  principles  are  usually  referred  to  as  'common  safety  methods'  (CSM).  The 
CSMs  shall  describe  how  safety  levels  as  well  as  the  achievement  of  safety  targets  and 
compliance with other safety requirements are assessed by elaborating and defining: 

a)  risk evaluation and assessment methods, 

b)  methods  for  assessing  conformity  with  requirements  for  the  award  of  safety 
certificates  and  safety  authorisations  issued  in  accordance  with  Articles  10  and  11 
2004/49/EC, and 

c)  methods to check that the structural subsystems of the railway system are operated and 
maintained  in  accordance  with  the  relevant  essential  requirements,  as  far  as  they  are 
not yet covered by the technical specifications for interoperability. 

a) Risk evaluation and assessment methods 

On  11  July  2012,  ERA  addressed  the  Recommendation  ERA/REC/02-2012/SAF  for  the 
revision of the Regulation (EC) No 352/2009 on the common safety method (CSM) on risk 
evaluation  and  assessment14.  Under  Article  6(4)  of  the  Directive,  CSMs  must  be  revised  at 
regular  intervals,  taking  into  account  the  experience  gained  from  their  application  and  the 
global development of railway safety and the obligations on Member States. 

The revision was based on an Agency report which analysed the experience gained with the 
CSM and its overall effectiveness. In addition, it covered further developments on the roles 
and the responsibilities of the assessment body referred to in Article 6 of Regulation (EC) No 
352/2009.  On  this  basis  the  Commission  adopted  the  Commission  Implementing 
Regulation  (EU)  No  402/2013  of  30  April  2013  on  the  common  safety  method  for  risk 
evaluation and assessment and repealing Regulation (EC) No 352/200915. 

The  risk  acceptance  criteria  used  to  evaluate  the  acceptability  of  a  risk  during  explicit  risk 
estimation  and  evaluation  could  not  be  included  because  of  lack  of  common  agreement 
between the sector and the authorities. ERA has continued developments in order to address a 
recommendation by 2015. 

b)  Methods  for  assessing  conformity  with  requirements  for  the  award  of  safety  certificates 
and safety authorisations 

In  accordance  with  Article  17(4)  of  the  Railway  Safety  Directive,  CSMs  should  provide  a 
framework for national safety authorities (NSAs) to harmonise their assessment and decision-
making criteria across the EU and the procedure to follow.  

14  
15  

OJ L 108, 29.4.2009, p. 4 

OJ L 121 of 3.5.13, p. 8 

9 

 
 
 
                                                            
More specifically: 

1)  Commission  Regulation  (EU)  No  1158/2010  of  9  December  2010  on  a  common 
safety  method  for  assessing  conformity  with  the  requirements  for  obtaining 
railway safety certificate16 provides to NSAs a methodology for assessing a railway 
undertaking’s  ability  to  comply  with  all  the  requirements  necessary  to  operate  in 
general and on the specific network for which it is seeking a certificate by assessing its 
safety management system. 

2)  Commission  Regulation  (EU)  No  1169/2010  of  10  December  2010  on  a  common 
safety  method  for  assessing  conformity  with  the  requirements  for  obtaining  a 
railway  safety  authorisation17  provides  to  NSAs  a  methodology  for  assessing  an 
infrastructure  manager’s  ability  to  comply  with  all  the  requirements  required  to 
operate  the  specific  network  for  which  it  is  seeking  authorisation  by  assessing  its 
safety management system. 

Both  Regulations  were  based  on  the  Recommendation  ERA/REC/SAF/09-2009  of  the 
European Railway Agency of 18 September 2009.  

c) Methods to check operation and maintenance. 

The purpose of certification and authorisation is not achieved by issuing the certificate or the 
authorisation  alone.  NSA  supervision  activities  are  the  cornerstone  of  maintaining  and 
improving safety performance across the EU. Each NSA needs to put in place arrangements to 
examine whether the processes outlined in the application for a safety certificate or a safety 
authorisation  are  being  delivered  in  operation  after  the  award  of  the  certificate  or  the 
authorisation.  

This post-award supervision regime should have a common methodology, as described in the 
Commission  Regulation  (EU)  No  1077/2012  of  16  November  2012  on  a  common  safety 
method for supervision by national safety authorities after issuing a safety certificate or 
safety authorisation18. 

At  the  same  time  and  in  line  with  a  system-based  management  approach,  it  was  recognised 
that  a  proactive  self-monitoring  by  railway  undertakings,  infrastructure  managers  and  by 
entities  in  charge  of  maintenance  was  essential  for  effective  safety  risk  management  and 
continuous improvement. A common  methodology  is  provided  by  Commission Regulation 
(EU) No 1078/2012 of 16 November 2012 on a common safety method for monitoring to 
be  applied  by  railway  undertakings,  infrastructure  managers  after  receiving  a  safety 
certificate or safety authorisation and by entities in charge of maintenance19. 

These  two  Regulations  were  based  on  Recommendation  ERA/REC/SAF/01-2011  of  the 
European Railway Agency of 16 December 2011.  

16  
17  
18  
19  

OJ L326 of 10.12.2010, p.11 

OJ L327 of 11.12.2010, p.13 

OJ L 320 of 17.11.2012, p.3 

OJ L 320 of 17.11.2012, p. 8 

10 

 
 
                                                            
d) Revision of the common safety methods 

After  a  few  years  of  application  of  the  CSMs  for  assessing  conformity  and  for  supervision, 
ERA has come to a conclusion that further harmonisation can only be achieved through the 
revision of the respective regulations. 

On this basis, the European Commission addressed to ERA the Commission Implementing 
Decision C(2014) 1649 of 14 March 2014 on a mandate to the European Railway Agency 
for  the  revision  of  the  common  safety  methods  for  conformity  assessment  and  the 
common safety methods for supervision. 

The Decision aims at a recommendation on the revision of CSMs no later than mid-July 2016 
identifying the necessary changes for a more detailed description of the standard processes to 
be applied for safety certification (both the assessment before issuing the certification and the 
post  award  supervision)  to  ensure  the  establishment  of  a  well-controlled  SMS-based 
certification regime and a more consistent approach across NSAs. 

This  revision  of  the  CSMs  will  be  a  major  step  in  the  achievement  of  a  Single  Safety 
Certificate regime. It will be made consistent with the provisions of the recast of the Railway 
Safety Directive as part of the 4th Railway Package (see Section 2.4). 

2.2.3.   Common safety targets (Article 7 of the Railway Safety Directive) 

Common  safety  targets  (CSTs)  are  quantitative  measures  of  risk  allowing  assessment  of 
whether the current safety levels of the railways in the Member States are at least maintained. 
In  the  long  term,  they  could  also  help  to  reduce  the  current  differences  in  railway  safety 
performance and the related barriers to market opening. Railway transport is the only mode of 
transport for which safety targets have been prescribed by European legislation. The CSTs are 
EU-wide maximum risk values, the national reference values (NRVs) are the maximum risk 
levels set for individual Member States. The risk level is measured in terms of the number of 
weighted  fatalities  and  serious  injuries 20  per  train-km.  There  are  risk  categories  for 
passengers, employees, level-crossing users, unauthorised persons on railway premises, others 
and  those  applied  to  society  as  a  whole.  The  Directive  prescribes  a  progressive  approach 
consisting of several steps: 

a) First set of draft common safety targets 

Article 7 of the Railway Safety Directive requires, among others, (a) that draft common safety 
targets  should  be  drawn  up  by  the  European  Railway  Agency  under  mandates,  (b)  that  the 
first set of draft common safety targets should be based on an examination of existing targets 
and  safety  performance  in  the  Member  states  and  should  ensure  that  the  current  safety 
performance of the rail system is not reduced in any Member State. 

20  Weighted fatalities and serious injuries (FWSI) are the normalised measure of railway safety outcome. One 
seriously injured person is considered as 0.1 fatalities and added to the number of fatalities in the given year. 

11 

 
 
 
 
                                                            
On this basis, the Commission Decision 2010/409/EU of 19 July 2010 on common safety 
targets as referred to in Article 7 of Directive 2004/49/EC (21) has been adopted, following 
the  Recommendation  ERA/REC/03-2009/SAF  of  the  European  Railway  Agency  of  18 
September 2009 on Common Safety Targets. 

The first set of common safety targets was understood as a first step of a process which will 
ensure  that  existing  safety  levels  are  maintained  and,  where  reasonably  practicable, 
continuously  improved.  With  this  first  step,  a  transparent  framework  was  put  in  place  for 
monitoring the global safety performance of railways across the European Union.  

b) Second set of draft common safety targets 

As a second step, the Decision was updated by making use of 6-year instead of 4-year time 
series of statistical data on railway accidents and related consequences. This was intended to 
enable the Commission to take further decisions based on data of a better quality. 

The  second  set  of  common  safety  targets,  required  by  Article  7(3)  of  the  Railway  Safety 
Directive,  builds  on  the  experience  gained  from  the  first  set  of  common  safety  targets  and 
their  implementation.  Although  safety  levels  are  already  adequate  all  over  the  European 
railway systems, this  will  allow  steering the national  railway  systems  of  the  Member  States 
with a lower safety performance closer to the best "safety performers". 

The  Commission  Decision  2012/226/EU  of  23  April  2012  on  the  second  set  of  common 
safety  targets  as  regards  the  rail  system22  was  based  on  ERA’s  recommendation 
ERA/REC/05-2011/SAF of 26 August 2011. 

The decision was later amended by the Commission Implementing Decision 2013/753/EU 
of 11 December 2013 amending Commission Decision 2012/226/EU on the second set of 
common safety targets for the rail system23, following the annual assessment of ERA. This 
last Decision was based on ERA’s recommendation ERA/REC/06-2013/SAF of 16 July 2013. 

c) Third set of common safety targets 

According  to  Article  7  (5),  the  common  safety  targets  will  be  revised  at  regular  intervals, 
taking  into  account  the  global  development  of  railway  safety.  To  this  aim,  the  Commission 
adopted  a  Commission  Implementing  Decision  C(2011)5158  on  a  mandate  to  the 
European  Railway  Agency  for  the  revision  of  common  safety  targets  and  the  related 
common safety method for the period 2011-2015. According to this Mandate, ERA should 
deliver its recommendation for the amendment of the common safety method and including 
the third set of safety targets by June 2015. 

21  
22  
23  

OJ L189 of 22.7.2010, p. 19 

OJ L189 of 22.7.2010, p. 19 

OJ L 334 of 13.12.13, p. 37 

12 

 
 
 
 
                                                            
2.2.4.   Certification of the entities in charge of maintenance for freight wagons  

(Article 14a of the Railway Safety Directive) 

After  the  tragic  rail  accident  occurred  in  Viareggio,  Italy,  on  29  June  2009,  due  to  the 
derailment  of  a  freight  wagon  and  the  explosion  of  its  content,  leading  to  more  than  30 
fatalities,  the  European  Commission  and  ERA  decided  to  accelerate  the  establishment  of  a 
system of certification for the ECM as required by article 14a of the Railway Safety Directive. 

The  Commission  Regulation  (EU)  No  445/2011  of  10  May  2011  on  a  system  of 
certification  of  the  entity  in  charge  of  maintenance  for  freight  wagons  and  amending 
Regulation (EC) No 653/200724 provided a framework for the harmonisation of requirements 
and methods to assess the ability of entities in charge of maintenance to ensure the safe state 
of running of any freight wagon for which it is in charge.  

The purpose of the certification system is to provide evidence across the Union that an entity 
in charge of maintenance has established its maintenance system and can meet the harmonised 
requirements laid down in this Regulation. Without prejudice to the responsibility of railway 
undertakings and infrastructure managers for the safe operation of the train, the ECM should 
ensure that the freight wagons for which it is in charge of maintenance are in a safe state of 
running by means of a system of maintenance. 

This  Decision  was  based  on  the  Recommendation  ERA/REC/06-2010/SAF  of  the  European 
Railway  Agency  of  8  July  2010  on  a  System  of  Certification  for  Entities  in  Charge  of 
Maintenance.  

2.3.   National safety rules 

Since  the  European  Union  took  efforts  to  revitalize  the  railway  market,  complex  and 
unnecessary national safety rules (NSR) were seen as one of the major obstacles to achieve 
the goal of a single European rail area, as well as having the potential to create unnecessary 
safety  risks.  The  Railway  Safety  Directive  introduced  measures  in  2004  that  gradually 
harmonised  and  reduced  the  need  for  NSR,  improving  overall  transparency.  Therefore, 
Member  States  should  keep  their  system  of  national  rules  updated,  deleting  obsolete  rules. 
After  several  years,  limited  progress  has  been  made  in  Member  States  in  cleaning  up  NSR 
made  redundant  by  the  present  EU  safety  system.  Therefore  in  December  2010,  the  RISC 
decided to set up a Task Force on NSR in order to clarify some uncertainties about NSR and 
foster best practices. 

2.3.1.   The Task Force on national safety rules and the rule management tool 

The activity of the Task Force on NSR (2011-2012) covered four major topics: the definition 
of NSR and overlaps with other rules, the procedures for improving transparency of the rule 
systems,  procedures  to  clean-up  the  rule  systems  and  proposals  for  the  future  legal 
framework.  To  identify  the  scope  for  NSR,  the  Task  Force  developed  a  ‘rule  management 
tool’ providing an overview of the existing European railway legislation: where requirements 

24  

OJ L 122 of 11.5.11, p. 22 

13 

 
 
 
 
                                                            
are already covered by EU legislation, the Member States may not impose any NSR, while, 
where there are exceptions, there is room for NSR.  

The European Railway Agency will continuously improve the rule management tool with the 
aim to provide guidance for the Member States. An updated version of the rule management 
tool is available on ERA website together with the Final Report on the Task Force: 
http://www.era.europa.eu/Document-Register/Pages/Report-NSR-TF.aspx 

ERA is preparing a proposal to give a legal basis for the application of the rule management 
tool. 

2.3.2.   Notif-IT: database of national safety and national technical rules 

Notif-IT  is  the  main  informatics  application  for  dealing  with  the  notification  of  new  NSRs. 
ERA assists the Commission in the setting up, operation, administration and management of 
the databases, in the maintenance and improvement of Notif-IT and provides assistance to the 
users. 

Early  review  of  draft  national  rules  is  considered  as  a  key  development  to  improve  the 
transparency  and  to  prevent  the  adoption  of  rules  by  the  Member  States  that  are  not  in  line 
with the EU legislative framework. To this end the Commission supported by ERA developed 
a new module of Notif-IT allowing the notification of draft rules, at an early stage. With this 
module  stakeholders  will  be  given  the  opportunity  to  comment  on  draft  rules  and  the 
comments will be taken into account in the evaluation by the Commission, assisted by ERA. 
The  purpose  is  to  prevent  introduction  of  rules  which  may  have  a  discriminatory  effect,  or 
constitute a disguised restriction on rail transport operations between the Member States and / 
or infringe EU law. The new module is operational since April 2014.  

2.3.3.   Follow-up of the recommendations of the Task Force 

The conclusions of the report on the activity of the Task Force included recommendations for 
the  dissemination  of  best  practices  and  cleaning-up  the  rule  systems  of  the  Member  States, 
procedures for improving transparency of the rule systems, and proposals for the future legal 
framework.  These  recommendations  have  been  followed  by  the  Commission  and  by  ERA 
according to their respective competences: 

a) Dissemination activities 

The Task Force on NSRs entailed ERA launching a dissemination campaign. ERA enhanced 
the bilateral and multilateral cooperation and coordination, especially through the Network of 
contact persons for NSR notification and through the RISC.  

In  2013  ERA  carried  out  dissemination  workshops  in  Hungary,  Austria,  Portugal  and 
Denmark.  This  included  customized  information  and  dialogues,  evaluation  of  the  system  of 
national safety rules and identification of specific priorities in each visited Member State with 
a  particular  focus  on  the  application  and  update  of  the  rule  management  tool,  on  the 
improvement of Notif-IT and on monitoring of the progress in cleaning up the rule systems. 

14 

 
 
 
 
 
b) Procedures to clean up the national safety rule systems in Member States 

The  Task  Force  recommended  using  the  rule  management  tool  for  cleaning  up  the  Member 
States  rule  systems.  Member  States  should  revise,  clarify  and/or  reduce  these  rules  as 
appropriate. Notifications should be updated accordingly. 

Reducing NSR and ensure that the key actors recognises and consistently fulfils their safety 
responsibilities may be a deep cultural change in some Member States. Rule cleaning means 
first  of  all  the  understanding  of  the  purpose  for  each  rule,  placing  it  at  the  right  level  and 
integrating  them  into  the  safety  management  system.  NSR  should  be  strictly  limited  to  a 
defined  safety  objective.  Unfortunately,  the  experience  shows  that  some  draft  NSRs  are  too 
prescriptive,  providing  for  detailed  obligations  that  instead  should  be  adapted  to  the 
specificity  of  each  railway  undertaking.  In  doing  this,  Member  States  may  introduce 
discriminations, giving an advantage to the domestic railway undertakings in comparison to 
the others. The correct way to ensure the fulfilment by railway undertakings and infrastructure 
managers is ensuring that the objective of the rules is taken in consideration in their respective 
safety management system. 

ERA continued to support the Commission and the Member States in their efforts to improve 
both  transparency  and  gradual  reduction  of  national  safety  rules.  By  2016  ERA  will  have 
implemented the action plan identified in the final report of the Task Force on NSRs.  

c) Procedures for improving and promoting transparency  

Early identification of draft rules is crucial for improving the transparency and to prevent at 
an early stage the adoption of rules which were not in line with the EU legislative framework. 
When  there  is  a  justified  need  for  NSR,  the  Railway  Safety  Directive  imposes  a  number  of 
principles,  responsibilities  and  tasks  of  the  Member  States  and  NSA  that  apply  on  different 
stages of NSR development. The Task Force analysed legal requirements and discovered best 
practice for their establishment and enforcement, including wide consultation in the Member 
State,  and  publication  of  adopted  rules.  Member  States  should  verify  their  existing  practice 
accordingly and make relevant steps for improvement of NSR transparency. 

The Task Force clarified that it is not a good practice to introduce rules in an urgent manner. 
Nevertheless for some “urgent” rules it was recognized, that there might be safety reasons to 
adopt  them,  before  the  Commission  has  completed  their  evaluation  as  a  draft  rule.  The 
adoption of any rule will not stop their evaluation. The Commission will also check if there 
were grounds for urgency25. 

Moreover,  ERA  defined  a  method  to  monitor  progress  with  transparency  and  reduction  of 
national safety rules and to steer improvements in Member States. This method is composed 
of  the  Transparency  Barometer  addressed  to  the  railway  sector  and  Transparency  Survey 
addressed to the national safety authorities and Member States. 

25   To the specific purpose of addressing urgent matter (e.g.; after an accident) ERA is currently working for 

establishing a Quick Response Procedure. 

15 

 
 
 
                                                            
d) Proposals for the future legal framework 

Following  the  analysis  of  existing  practices,  the  Task  Force  suggested  some  changes  to  the 
legal  framework  aimed  to  simplify  the  NSR  system  and  to  help  its  consistent  evolution 
pursuing the objectives of the Railway Safety Directive. Notably, the Task Force proposed to 
merge  the  NSR  and  the  national  technical  rules  adopted  according  to  the  Interoperability 
Directive26. 

In  the  framework  of  the  4th  Railway  Package  (Cf.  Section  2.4)  the  Commission  proposed  a 
review  of  both  the  Directives  on  railway  safety  and  interoperability.  The  legal  base  for  the 
adoption of new rules still remains separate, although the former NSR and national technical 
rules  were  both  designated  as  'national  rules'  irrespective  from  the  safety  or  technical 
justification. The procedure is harmonised in both directives. 

Taking into account the progress with the harmonized European legislation, room for 'national 
rules'  remains  limited.  The  Task  Force  proposed  to  clarify  the  rationale  for  remaining  rules 
and to delete Annex II from the revised Railway Safety Directive.  

2.4.   The 4th Railway Package and the recast of the Railway Safety Directive 
In the last decade, the EU railway market has seen massive changes, gradually introduced by 
three legislative ‘railway packages’ (with some accompanying acts) intended to open up the 
national  markets  and  make  railways  more  competitive  and  interoperable  at  the  EU  level, 
while maintaining a high level of safety. However, despite the considerable development of 
the ‘EU acquis’ establishing an internal market for rail transport services, the modal share of 
rail  in  intra-EU  transport  has  remained  modest.  Therefore  the  Commission  has  planned  to 
come forward with the 4th Railway Package in order to enhance the quality and efficiency of 
rail services by removing the remaining market obstacles.  

In  particular,  the  Railway  Safety  Directive  has  been  reviewed  focussing  on  the  removal  of 
administrative  and  technical  barriers,  in  particular  by  establishing  a  common  approach  to 
safety and progressive technical harmonisation. This proposal for a deep review ("recast") has 
been included in the 4th Railway Package. The elimination of barriers may increase economies 
of  scale  for  railway  undertakings  active  across  the  EU,  decreasing  administrative  costs  and 
accelerating administrative procedures, as well as avoiding disguised discrimination and thus 
contributing to the competitiveness of rail sector versus other modes of transport. The "recast" 
of  the  Railway  Safety  Directive  is  therefore  fully  consistent  with  the  objectives  of  the  4th 
Railway Package. 

2.4.1.   Revision of the Safety Certification and migration towards a single safety certificate 

The  simplification  of  the  process  of  granting  safety  certificates  to  the  railway  undertakings 
(RU) was the main driver for the recast of the Railway Safety Directive.  

26  Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability 

of the rail system within the Community (OJ L 191, 18.7.2008, p. 1). 

16 

 
 
 
 
                                                            
The current certification system requires several applications for the RU intending to operate 
in more than one Member State: 

- 

- 

Safety  certificate  “Part  A”,  granted  only  once  in  the  Member  State  where  the  RU  is 
first established. It is valid through the whole EU; 

Safety  certificate  “Part  B”,  granted  in  each  Member  State  where  the  RU  intends  to 
operate. 

The  purpose  of  the  recast  is  migrating  from  the  current  two  parts  system  towards  a  single 
safety  certificate  valid across  the  EU.  Therefore,  it  will  no  longer  be  necessary  for  a  RU  to 
apply for a Part B certificate separately. 

The  migration  towards  a  single  certificate  principle  was  already  established  in  the  Railway 
Safety Directive in force: Article 10 (7) of Directive 2004/49/EC prescribes that ‘Before 30 
April 2009 ERA shall evaluate the development of safety certification and submit a report to 
the  Commission  with  recommendations  on  a  strategy  for  migration  towards  a  single 
Community  safety  certificate’  replacing  the  current  two  part  system  (Part  A/B).  Single  EU 
safety certificate development and implementation has always been a long term objective. It 
was never a question of 'if' but rather of 'when' it would be introduced. 

In its interim report of 2009, the European Railway Agency explained that it was too early to 
make  a  recommendation  and  that  more  information  was  needed  in  order  to  ensure  an 
informed  debate.  Three  years  later,  on  7  March  2012,  ERA  held  a  workshop  with 
stakeholders. Finally, ERA submitted a report to the European Commission in July 2012 with 
Recommendation  ERA/REC/10/2011  on  the  migration  to  a  single  EU  safety  certificate 
proposing  a  strategy  for  the  migration  through  the  revision  of  the  current  regulatory 
framework. 

The migration was an opportunity to revise the role of the national safety authorities (NSAs) 
and to reallocate the responsibilities between them and ERA. 

To prepare and monitor the way towards a single safety certificate regime, a task force under 
the auspices of the Rail and Interoperability Committee has been set up. 

When the new Railway Safety Directive will be adopted by the Council and by the European 
Parliament,  the  regulatory  framework  (in  particular  Regulations  653/2007,  1158/2010,  and 
1077/201227)  need  to  be  adapted  to  make  the  Single  Safety  Certificate  effective.  The  issues 
that  were  identified  as  “preconditions”  by  ERA  in  its  report  on  the  development  of  a 
migration strategy towards a single safety certificate will continue to be considered as part of 
ERA  Work  Programme,  while  the  programme  plan  for  the  Single  Safety  Certificate  Task 

27   Commission Regulation (EC) No 653/2007 on the use of a common European format for safety certificates 
and  application  documents  in  accordance  with  Article  10  of  Directive  2004/49/EC  of  the  European 
Parliament  and  of  the  Council  and  on  the  validity  of  safety  certificates  delivered  under  Directive 
2001/14/EC (OJ L 153, 14.6.2007, p. 9)  
Commission Regulation (EU) No 1158/2010 on a common safety method for assessing conformity with the 
requirements for obtaining railway safety certificates (OJ L 326, 10.12.2010, p. 11) 
Commission Regulation (EU) No 1077/2012 on a common safety method for supervision by national safety 
authorities after issuing a safety certificate or safety authorisation (OJ L 320, 17.11.2012, p. 3) 

17 

 
                                                            
 
Force  is  focused  on  the  activities  needed  to  accelerate  the  achievement  of  a  single  safety 
certificate. 

The introduction of new roles and responsibilities for ERA needs to be prepared as well inside 
this framework: ERA Recommendation  to  the  Commission on the migration to a single EU 
safety certificate did not cover the scenario in which the task of assessing an applicant’s safety 
management  system  and  consequently  granting  a  single  safety  certificate  is  performed  by 
ERA. 

Since  several  workstreams  of  the  Safety  Unit  of  ERA  are  linked  to  the  achievement  of  the 
single  safety  certificate,  a  Programme  Management  approach  is  needed  to  ensure  the  right 
momentum. A task force constituted of members of the Railway Interoperability and Safety 
Committee  (RISC)  has  been  appointed  to  drive  the  programme  towards  its  successful 
delivery.  The  Taskforce  will  be  provided  with  the  information  collected  from  the  various 
related  projects  of  ERA  and  will  contribute  to  monitoring  the  efficiency  of  the  overall 
programme. The reasons for having a TF under the auspice of the RISC are: 

1.  To  ensure  the  right  level  of  Commitment  :  the  development  and  delivery  of 
harmonised  approaches  for  assessment  and  supervision  initiated  at  the  level  of  the 
National  safety  authorities  (including  the  NSA  Task  Force  on  Assessment  & 
Supervision)  is  not  delivering  results  according  to  a  time  plan  compatible  with  the 
expectations  of  the  Commission's  proposal  for  the  4th  Railway  Package;  it  must  be 
enlarged  to  the  related  stakeholders  including  Member  States  representatives  as  well 
as Sector representatives to get the right level of involvement and commitment; 

2.  To provide the necessary Mandate: having a Task Force at RISC level for driving this 
programme (which is also paving the way for the Commission’s proposal of recast of 
Directive 2004/49/EC as part of the 4th Railway Package) will provide the necessary 
basis  for  modifying  the  current  regulatory  framework  which  is  not  (yet)  part  of  the 
current mandate of ERA; 

The programme plan of the Task Force has been agreed at RISC in January 2014. The kick-
off meeting was held on 10 June 2014 and was mainly devoted to organisational issues and to 
some  constructive  exchanges  of  views.  12  Member  States,  Switzerland,  Norway  and  three 
sector associations (CER, EIM, and ERFA) were represented. 

2.4.2.   A moving environment for safety 

The  revision  of  the  Railway  Safety  Directive  is  also  an  opportunity  to  adapt  the  text  to  the 
evolution of the railway market where new professional actors or entities have been created. 
The  lessons  from  severe  railway  accidents  show  that  these  actors  may  assume  important 
responsibilities with regards to safety. 

All  actors  involved  in  the  safety  operations  should  implement  the  necessary  risk  control 
measures  (ECM,  consignor,  manufacturer  …)  and  are  responsible  for  the  transmission  of 
relevant  information  about  safety.  However,  the  main  principle  set  up  in  the  Commission 
proposal remained unchanged: the responsibility for the safe operation of the rail system and 
the  control  of  the  associated  risks  is  laid  upon  the  infrastructure  managers  and  railway 
undertakings.  These  actors,  together  with  entities  in  charge  of  maintenance  will  ensure  that 
their contractors implement the appropriate risk control measures. 

18 

 
 
2.4.3.   Recast of the Railway Safety Directive: inter-institutional dialogue 

−  Proposal of the Commission: adopted on 30.1.2013 

−  Opinion of European Committee of Regions: provided on 8.10.2013 

−  Opinion of European Economic and Social Committee: provided on 22.8.2013 

−  TTE Council general approach: agreed on 10.10.2013 

−  EP position in first reading adopted on 26.2.2014 

−  TTE Council political agreement: agreed on 5.6.2014 

Trialogues started under Italian Presidency in October 2014. 

19 

 
 
 
3. 

MONITORING THE IMPLEMENTATION AND THE SAFETY 
PERFORMANCE 

3.1.   Measures notified by the Member States for transposition of Directive 

2004/49/EC  

The Commission, assisted by the European Railway Agency (ERA), analysed the legislative 
measures  notified  by  the  Member  States  for  national  transposition  of  Directive  2004/49/EC 
(Railway Safety Directive) checking if the transposition into the national legal framework had 
been made according to the aim of its provisions. 

If the Railway Safety Directive is transposed incorrectly, common safety measures cannot be 
effectively  applied  within  the  European  railway  system  and  the  rail  safety  framework  as  a 
whole may not operate as intended. Deviations from the system set up by the directive may 
have serious consequences, such as: 

• 

Incorrect or unclear transposition of the scope of the Directive (Article 2) could lead to 
a fragmented safety systems and to different levels of safety across Europe; 

•  Failing  to  allocate  the  responsibility  for  safe  operations,  risk  management  and  risk 
control  to  railway  undertakings  and  infrastructure  managers  (Article  4)  may  lead  to 
unreliable  railway  sectors  where  safety  responsibilities  are  confused  and  risks  left 
uncontrolled; 

•  Failing  to  ensure  full  independence  to  the  NSAs  (Article  16)  may  undermine  the 
achievement  of  the  transparent,  and  non-discriminatory  common  railway  safety 
system; 

•  Failing to ensure full independence and appropriate resources to the NIBs (Articles 20 
and  21)  may  undermine  the  possibilities  of  the  NIBs  to  carry  out  their  tasks  and  to 
ensure effective independent investigation. 

On  the  basis  of  questionnaires  ('EU-Pilot')  as  an  initial  request  of  information  from  the 
Member States regarding transposition of Railway Safety Directive and in the cases where the 
Member  States  failed  to  explain  the  missing  or  incorrect  transposition,  the  Commission  has 
launched the procedures of infringement.  

Enforcement of a Directive follows a 3-phase process: 

1)  A  formal  notice  is  sent  to  the  Member  State  informing  of  the  short-comings  of  its 

legislative measures. 

2)  If  the  problem  persists,  the  Commission  would  address  a  reasoned  opinion  to  the 
Member State warning of possible court action if it cannot amend or justify the short-
comings mentioned above. 

3)  Finally the Member State may be referred to the Court of Justice.  

Only  a  few  procedures  arrive  at  the  last  stage:  it  is  preferable  for  all  parties  to  avoid  this 
resource-consuming  step  and  address  the  pending  issues  at  the  early  phases  of  the  process 
through dialogue and clarification or corrective actions. 

20 

 
Concerning  the  measures  notified  by  the  Member  States  for  transposition  of  Directive 
2004/49/EC,  26  'EU-Pilot'  cases  have  been  handled,  of  which  one  case  was  closed  at  pre-
infringement stage. 

19 infringement cases have been opened, of which 5 were closed following corrective actions 
taken  by  the  Member  State.  One  Member  State  has  been  referred  to  the  Court.  At  present, 
there  are  still  six  procedures  at  EU-Pilot stage  and  14  infringement  cases  ongoing  (October 
2014). 

3.2.   Managing and monitoring safety 

3.2.1.  Managing safety 

Railway  safety  in  the  European  context  is  managed  at  three  different  levels;  at  the  level  of 
operators, Member States and the EU.  

The  legal  framework  created  by  Directive  2004/49/EC  is  based  on  the  principle  of 
responsibilities  of  the  major  actors  of  the  railway  chain:  the  railway  undertakings  and  the 
infrastructure  managers.  They  are  responsible  for  assessing  all  risks  relating  to  the  safe 
operation  of  trains  and  establishing  a  safety  management  system  (SMS)  in  accordance  with 
Article 9 of the Directive. They are also responsible for self-monitoring their activities and for 
taking the necessary corrective measures. 

At  the  Member  State  level,  the  quality  of  the  SMS  is  evaluated  by  the  national  safety 
authorities  (NSAs)  when  issuing  to  the  railway  undertakings  and  to  the  infrastructure 
managers the safety certificate  or safety authorisation required for performing  their activity. 
The  NSAs  are  responsible  for  supervising  the  activities  of  the  railway  undertakings  and 
infrastructure  managers  during  the  period  of  validity  of  the  safety  certificate  or  safety 
authorisation. Supervision is assured at the national level with two main instruments defined 
in the Railway Safety Directive as audits and inspections. While the safety audits are typically 
the  result  of  longer-term  planning  and  follow  a  well-established  comprehensive  procedure, 
inspections  are  carried  out  as  irregular  checks  of  the  specific  procedures  or  operations  of  a 
railway undertaking. The NSAs should take a leadership in benchmarking, assuring that the 
railway undertakings and the infrastructure managers take their responsibilities, and supervise 
that appropriate preventive measures are taken, according to the SMS provisions. 

At  the  European  level,  ERA  supports  the  Commission  in  monitoring  safety.  On  an  annual 
basis  ERA  assess  the  achievement  of  the  common  safety  targets  (CSTs)  and  national 
reference values (NRVs) in accordance with the common safety method (CSM) defined in the 
Commission  Decision  2009/460/EC28,  and  in  particular  in  its  Article  4.  The  assessment 
concerns 26 of 28 EU Member States that have a railway system, plus Norway. For the first 
time, in 2014 the assessment was carried out for Croatia, which joined the EU in 2013.  

In accordance with the common safety method, a second set of CSTs/NRVs were applied for 
the third assessment carried out in 2012. The second set of CSTs/NRVs was adjusted in 2013 
following  the  fourth  annual  assessment  carried  out  by  ERA.  In  general,  the  second  set 

28   Commission  Decision  2009/460/EC  of  5  June  2009  on  the  adoption  of  a  common  safety  method  for 
assessment  of  achievement  of  safety  targets,  as  referred  to  in  Article  6  of  Directive  2004/49/EC  of  the 
European Parliament and of the Council, OJ L 150, 13.6.2009, p. 11. 

21 

 
 
                                                            
contains reference values that are slightly stricter compared to the values estimated in the first 
set (Figure 1). 

The  NRVs  and  the  second  set  of  CSTs  were  established  using  Eurostat  data  for  the  years 
2004-2009  and  published  as  Commission  Decision  2012/226/EU  in  2012,  which  was  later 
amended by the Commission Implementing Decision 2013/753/EU.  

The  assessment  carried  out  in  2014  used  the  risk  values  estimated  for  the  period  between 
2008-2012 and for the single year 2012 and compared them with the national reference values 
of the second set (risk estimated for the period between 2004-2009).  

For all railway user categories, the respective national reference value (NRV) was lower than 
the  corresponding  CST;  the  NRVs  represented  the  maximum  tolerable  level  of  the  risk  to 
which  it  refers  for  this  assessment.  As  with  the  assessments  carried  out  in  the  past,  NRVs 
represented the safety targets that were subject to the assessment of achievements as described 
in the CSM. 

In general, the results of the annual assessment of achievements of the CSTs/NRVs indicated 
that  railway  safety  performance  remains  acceptable  at  the  EU  level  for  all  the  categories  of 
railway  users.  The  past  assessments  of  achievements  of  the  CSTs/NRVs  rarely  resulted  in 
possible  or  probable  deterioration  of  safety  performance  for  individual  Member  States  (and 
never  for  the  Union).  In  these  instances,  the  Member  States  should  provide  a  satisfactory 
explanation for the result achieved. 

The  2014  Report  on  the  Assessment  of  achievement  of  Safety  Targets  may  be  found  at  the 
link: http://www.era.europa.eu/Document-Register/Pages/2014-Assessment-CSTs.aspx  

Nr./Data

2004

2005

2006

2007

2008

2009

2010

2011

2012

First (2010)

Second (2011)

Third (2012)

Fourth (2013)

Fifth (2014)

1st set of CSTs/NRVs

MWA (4 yrs)

1st set of CSTs/NRVs

OSP

MWA (4 yrs)

OSP

2nd set of CSTs/NRVs

MWA (5 yrs)

2nd set of CSTs/NRVs

2nd set of CSTs/NRVs (amended)

OSP

MWA (5 yrs)

OSP

MWA (5 yrs)

OSP

Figure 1: Overview of the annual assessments of achievements of the CSTs/NRVs carried out by 
ERA (29).  
Source: Railway Safety Performance in the European Union 2014 
http://www.era.europa.eu/Document-Register/Documents/SPR2014.pdf  

(29)  MWA=Moving weighted average, OSP=Observed safety performance. 

22 

 
 
 
 
 
                                                            
3.2.2.   Safety certification and Safety authorisation 

The  Railway  Safety  Directive  requires  the  railway  undertakings  (RUs)  to  hold  a  safety 
certificate issued by the national safety authority (NSA) to access the railway infrastructure. 
Similarly, Infrastructure managers (IMs) must obtain a safety authorisation from the NSA to 
manage  and  operate  a  rail  infrastructure  in  a  Member  State.  The  NSA  assesses  the  Safety 
Management  System  (SMS)  of  RUs  and  IMs  applying  for  safety  certificates  or  safety 
authorisations  against  the  requirements  set  out  in  the  Directive  and  the  common  safety 
methods. For the RUs, they are awarded a Part A safety certificate, which is valid throughout 
the  EU.  RUs  also  need  to  obtain  Part  B  certificates  for  each  Member  State  in  which  they 
operate,  relating  to  the  specific  requirements  for  safe  operation  on  the  relevant  network, 
including the authorisation of the vehicles used by the RU. 

There  were  a  total  of  1 088  valid  safety  certificates  in  EU-27  countries,  Norway  and 
Switzerland  (548  part  A  and  540  part  B  certificates) issued in accordance with the Railway 
Safety  Directive  and  valid  on  1  January  2014.  Figure  2  shows  the  repartition  of  the  Safety 
Certificates among the Member States.  

Figure 3 provides more details on the number of safety certificates per type of service, valid 
on 1st January 2014 and registered in the ERADIS database. It shows that a relatively small 
number  of  RUs  provide  cross-border  train  operations  in  Europe.  The  international  part  B 
safety certificates remain rather rare for RUs operating passenger train services; they are more 
common for RUs operating freight transport services. 

European  IMs  are  typically  state-owned  entities  with  national  coverage;  a  small  number  of 
IMs  that  are  privately  owned  manage  small  infrastructure  networks,  typically  at  ports. 
Detailed  information  about  IMs  with  safety  authorisation  is  currently  not  available  at  EU 
level. 

Figure 2: Number of valid Safety Certificates — Part A and B per Member State 
(1 January 2014) 
Source: Railway Safety Performance in the European Union 2014  
http://www.era.europa.eu/Document-Register/Documents/SPR2014.pdf 

23 

 
 
 
 
 
 
 
Figure 3: Number of valid Safety Certificates — Part A and B, international operations only, 
per type of service   
Source: Railway Safety Performance in the European Union 2014 
http://www.era.europa.eu/Document-Register/Documents/SPR2014.pdf 

3.2.3.   Safety overview 

Monitoring safety performance is one of the key tasks of the European Railway Agency. ERA 
collects, processes and analyses different sets of data in order to support recommendations on 
actions  to  be  taken.  In  this  way,  ERA  facilitates  evidence-based  policy-making  at  the  EU 
level. By continuously monitoring and analysing safety performance, ERA provides assurance 
that  the  objective  of  maintaining  and  improving  safety  where  reasonably  practicable  is 
achieved. 

In accordance with Article 9(2) of ERA Regulation30, ERA publishes a report on a biennial 
basis  since  2006.  This  report  is  one  of  the  visible  results  of  ERA’s  activities  in  monitoring 
safety performance.  It  is  also  part  of  ERA’s effort to provide to its stakeholders a thorough 
overview of the development of railway safety in the European Union. 

The basis for this report is information provided by the national safety authorities and national 
investigation bodies. According to Articles 18 and 23 of the Railway Safety Directive, these 
bodies have a legal obligation to report to ERA a set of defined information that can be used 
to assess the development of railway safety in the EU. Notably, the national safety authorities 
gather  common  safety  indicators,  defined  in  legislation,  from  the  railway  undertakings  and 
infrastructure  managers  which  provide  a  footprint  for  safety  performance  in  Member  States 
and the Union. Although this report is largely based on this data, it also includes additional 
information  gathered  from  other  sources  (notably  other  European  Commission  services),  as 
well as its own data derived from its oversight activities. 

30   Regulation (EC) No 881/2004 of the European Parliament and of the Council of 29 April 2004 establishing 

a European railway agency (Agency Regulation, OJ L 164 of 30.4.2004, p. 1) 

24 

 
 
 
 
 
                                                            
In 2012, railway safety continued to improve across the EU, with 2 068 significant accidents 
resulting in 1 133 fatalities and 1 016 seriously injured persons in the 28 countries. Accident 
figures have been decreasing considerably over the last six years; the casualty totals have seen 
slight, close to uniform, reductions over the same period (Figures 4a and 4b).  

Figure 4a: Number of fatalities per victim category (EU-28: 2006–2012) 

Figure 4b: Seriously injured persons per victim category (EU-28: 2007-2012)  
* Data not available for Croatia in the period 2006-2009  
Source: Railway Safety Performance in the European Union 2014  
http://www.era.europa.eu/Document-Register/Documents/SPR2014.pdf 

25 

 
 
 
 
 
Figure 5: Railway accidents with five or more fatalities (EU-28, 1980-2013) 31 
Source: Railway Safety Performance in the European Union 2014  
http://www.era.europa.eu/Document-Register/Documents/SPR2014.pdf 

Figure  6:  Fatality  risk:  Railway  fatalities  and  weighted  serious  injuries  per  million  train-km 
(2007-2012).  
Source: Railway Safety Performance in the European Union 2014 
http://www.era.europa.eu/Document-Register/Documents/SPR2014.pdf 

31  All EU countries, Norway and Switzerland, excluding Romania and Croatia for the period 1980–1989. 

Accidents on railway lines not covered by the Railway Safety Directive are also included. 

26 

 
 
 
 
 
 
 
 
 
                                                            
According to the figures published in the 2014 report, more than 2 000 significant accidents 
occur each year on the Member States railways. Accidents to persons caused by rolling stock 
in  motion  and  level-crossing  accidents  constitute  more  than  three  quarters  of  railway 
accidents, excluding suicides. In these accidents, around 1 200 people are killed and a similar 
number seriously injured each year. 

Available  historical  data  on  fatal  railway  accidents  shows  a  solid  gradual  improvement  in 
railway  safety  over  the  past  three  decades,  which  has  however  slowed  down  since  the  mid-
1990s  and  further  since  the  mid-2000s.  This  ‘softening’  of  the  trend  is  observable  when 
analysing  both  absolute  and  relative  figures  for  fatal  train  collisions  and  derailments  in 
Europe. The recording of significant accidents has only been fully harmonised in the EU since 
2010. Since then the trend in significant accidents has been aligned with the trend in casualty 
numbers.  

Accident  risk,  expressed  in  the  number  of  outcomes  per  exposure,  is  probably  the  best 
measure of a safety level. The framework for the evaluation of CSTs/NRVs also uses it as a 
basis  for  the  assessment  of  safety  levels  at  the  level  of  Member  States  and  the  Union. 
Considering  all  railway  fatalities  (excluding  suicides),  the  fatality  risk  (system  risk)  per 
million train-kilometres (train-km) in the period 2010-2012 was 0.3 killed per million train-
km in the EU. Similarly, one can estimate the fatality risk of railway passengers (passenger 
risk). This was 0.15 passengers killed per billion train-km in the period 2010-2012 (Figure 5). 
Comparison  of  fatality  risks  for  travelling  passengers  reveals  that  rail  is  the  safest  mode  of 
land transport in Europe. 

Estimating  risk  levels  for  different  Member  States  allows  us  to  produce  a  benchmark 
highlighting the best and worst performing countries. It appears that safety levels vary greatly 
among  Member  States.  One  third  of  them  have  a  significantly  higher  risk  than  others;  the 
variations  in  risk  within  that  group  of  Member  States  are  also  significant  (Figure  6).  It  is 
particularly remarkable that nine Member States have significantly higher risk than the others. 
A  systematic  approach  to  the  safety  performance  improvements  of  these  countries  would 
mean a major step towards genuine EU-wide safety targets in the future. 

3.2.4.   Occurrences investigated by NIBs 

According to the provision of the Railway Safety Directive, the NIBs have to investigate all 
serious accidents that occur in their territory and may in addition investigate other accidents 
and incidents. The occurrences investigated by the NIBs are subject to mandatory reporting to 
ERA.  Each  accident  is  reported  to  ERA  twice:  as  a  notification  of  the  opening  of  an 
investigation and when the final report is sent to ERA. Both records are available in ERA’s 
database ERAIL. 

Every year, more than 200 accidents and incidents are investigated in the Member States. This 
number  has  been  slightly  increasing  over  recent  years,  since  more  and  more  NIBs  have 
decided  to  open  an  investigation  into  accidents  not  categorised  as  serious  according  to  the 
Railway Safety Directive. The number of serious railway accidents investigated by NIBs has 
been stable since 2007 at around 40 per year. 

While the majority of serious accidents in the EU are investigated by the NIBs, the share of 
other  similar  accidents  and  other  accidents  and  incidents  investigated  vary  greatly  among 
countries. NIBs carried out nine investigations per year on average in the period 2010-2012. 

27 

 
 
The approach and methods to accident investigation vary between Member States. One of the 
tasks of ERA is to facilitate a common understanding of the approach of the Safety Directive 
within  the  European  Union.  Current  projects  include  work  on  accident  causation,  safety 
recommendations and investigator training. 

The  investigations  should  not  be  limited  to  the  identification  of  the  direct  causes.  This  may 
lead  to  the  risk  that  systemic  factors  in  the  SMS  of  a  RU  or  IM  or  even  in  the  regulatory 
framework remain undetected and safety recommendations may just address the symptoms of 
a safety problem but not its causes. 

ERA  works  with  the  NIBs  on  accident  investigation  methods,  reporting,  recommendations 
and exchange of good practice. With ERA support, the NSAs and NIBs have developed joint 
guidance on safety recommendations32. 

3.2.5.   Monitoring activities supported by ERA 

a) NSA cross-audit programme 

Supported by ERA, the NSAs agreed to a programme of audits, to share best practice as well 
as  evaluate  the  performance  of  their  three  main  activities  required  by  the  Safety  and 
Interoperability  Directives:  safety  certification  and  safety  authorisation,  supervision  and 
authorisation for placing in service of vehicles. 

From  2011  to  2013  the  NSA  Network  carried  out  a  series  of  Cross  Audits  of  each  other 
through  a  pilot  phase  of  6  audits.  A  Programme  Manual  was  adopted  to  ensure  the  audits 
would  be  conducted  using  a  consistent  methodology,  and  Audit  Protocols,  against  which 
NSAs  were  audited.  ERA  trained  around  30  NSA  and  ERA  staff  to  be  auditors  for  the 
purposes of the Cross Audits. 

Following a successful pilot phase, the NSA Cross-Audit Programme has launched its 1st full 
Audit Cycle (2013-2018), in which all the NSAs will be audited once. During the first year, 
the NSAs of Channel Tunnel, Sweden, Romania and Austria have been audited. 

The programme was set up in order to: 

•  Evaluate  performance  of  the  NSA  duties  and  responsibilities  under  the  Safety 

Directive; 

•  support harmonization of their processes and decision making principles; and  

• 

identify any problems related to implementation of the EU legislation.  

At  this  stage,  the  audit  programme  focuses  on  the  quality  of  NSA  processes,  and  does  not 
look  critically  at  the  decision-making  or  risk  assessment  applied  as  part  of  those  processes.  
Early  indications  are  that,  while  all  NSAs  appear  committed  to  continuous  improvement, 
many  of  them  are  at  an  early  stage  in  terms  of  developing  and  implementing  quality 
processes. Nevertheless, the programme has proven successful at driving improvement within 

32   Guide available on ERA web site: http://www.era.europa.eu/Document-Register/Pages/guidance-on-safety-

recommendations-Safety-Directive-Art-25.aspx  

28 

 
 
                                                            
those NSAs audited and those providing auditors.  In addition, the audits provide a structured 
and  consistent  way  to  understand  how  well  these  key  elements  of  national  regulatory 
frameworks  are  functioning.    Within  the  agreed  boundaries  of  the  programme  (the  audit 
findings are not public), this information can also help ERA by complementing the statistics 
and other information available to develop a fuller picture. 

The current cycle is scheduled to end in 2018, by which time the changes brought by the 4th 
Railway Package are likely to shape the revision of the programme. 

b) NIB voluntary assessments 

The first NIB assessment programme was launched by ERA in 2013. The objective of these 
voluntary  assessments  is  to  support  NIBs,  who  have  a  leading  role  in  rail  accident 
investigation  in  their  own  Member  States,  to  share  good  practices  and  to  identify  practical 
improvements  to  their  work,  by  assessing  their  current  performance.  The  assessments  are 
made  on  request,  reflecting  the  individual  commitments  of  NIBs  to  continuously  improve 
their organisations in this structured and systematic way. 

The  voluntary  assessment  relies  on  the  method  developed  by  the  NIBs  in  cooperation  with 
ERA.  After  a  successful  pilot  assessment  of  the  Hungarian  NIB  in  2012,  two  assessments 
started in 2013. At the same time, two audits were carried out at the request of the European 
Commission  and  the  National  Parliamentary  Committee  of  one  Member  State  in  2013.  The 
assessments  were  conducted  by  ERA  staff  and  showed  that  the  two  NIBs  manage  their 
performance:  they  deliver  good  investigation  reports  including  recommendations  with  the 
intention  to  prevent  reoccurrence  and  at  the  same  time  seek  to  continuously  improve  the 
investigation process by developing and applying defined processes.  

These  assessments  also  showed  that  while  all  assessed  NIBs  have  effectively  carried  out 
investigation  into  past  accidents,  the  approaches  vary  greatly  between  countries.  In  some 
instances, the transposition and the implementation of the legal framework created difficulties 
for the NIB to work  effectively  and  independently. In some others, the amount of available 
resources had a great impact on the extent and quality of the work of the organisation. 

3.3.   Certification of the entities in charge of maintenance: overview 

3.3.1.   Status of different schemas (ART 10.1 of the Regulation (EU) 445/2011) in EU and 

non EU Contracting States.  

According  to  the  article  10.1  of  the  Commission  Regulation  (EU)  n°  445/2011  of  10  May 
2011, the Member States have to choose between accreditation or recognition of the national 
certification bodies or shall nominate the NSA as certification body. The situation in 2014 is 
the following: 

•  “Accreditation” means that the certification body is accredited by a national accreditation 
body.  Four  Member  States  have  chosen  the  accreditation  scheme  (Austria,  Belgium, 
Denmark, France) + Norway, Switzerland; 

29 

 
 
 
•  “Recognition”  means  that  the  certification  body  is  a  body  recognized  by  the  Member 
State.  Three  Member  States  who  has  chosen  recognition  (Italy,  Portugal,  Slovak 
Republic); 

•  “NSA as certification body” means that the NSA was designated by the Member state as 
certification  body.  15  NSAs  acting  are  acting  as  certification  body  (Bulgaria,  Croatia, 
Czech Republic, Estonia, Germany, Greece, Hungary, Ireland, Latvia, Lithuania, Poland, 
Romania, Slovenia, Spain, The Netherlands); 

•  Four  Member  states  have  chosen  both  accreditation  and  NSA:  Finland,  Sweden, 
Luxembourg  (with  the  NSA  for  the  RU  and  the  IM  when  they  act  as  ECM  and 
accreditation for all the others) and, temporarily, United Kingdom (to be reviewed after 
two years).  

Within  this  certification  scheme,  each  MS  put  at  disposal  of  the  domestic  ECM  at  less  one 
type of certification.  

However, the ECMs are always free to choose between the bodies put at disposal at national 
level and any accredited or recognized body in another European country. 20 ECMs out of the 
248 certified ones have preferred this option. 

3.3.2.   State of play of ECM certification 

Regulation  (EU)  No  445/2011  of  10  May  2011  on  a  system  of  certification  of  the  entity  in 
charge of maintenance for freight wagons entered into force on 31 May 2011. Since then, the 
system  delivered  successful  results.  The  number  of  ECMs  certified  in  accordance  with  the 
new system of certification increased from 10 to 248 from May 2012 to March 2014 (Figures 
7 and 8). 

Figure 7: evolution of the number of ECM Certificates issued in accordance with the Regulation 
(EU) 445/2011 

30 

 
 
 
Figure  8:  Distribution  of  the  number  of  ECM  certificates  in  accordance  with  the  regulation 
445/2011 by Member States (248 certificates in March 2014). 

A similar trend was observed for the number of maintenance workshops certified according 
with the system of certification set in Regulation (EU) 445/2011. Although the system set up 
in  the  regulation  is  voluntary,  the  number  increased  from  1  to  169  during  the  same  period 
(Figure 9).  

Figure  9:  evolution  of  the  number  of  the  certificates  for  maintenance  workshops  issued  in 
accordance with the Regulation (EU) 445/2011 

During  a  transitory  period  the  Regulation  provides  for  the  acceptance  and  recognition  of 
certificates issued according to certain systems used before its entry into force: 

1. 

The certificates issued by a certification body no later than 31 May 2012 on the basis 
of principles and criteria equivalent to those of Memorandum of Understanding signed 
by Member States on  14  May 2009, will be recognized as being equivalent to ECM 

31 

 
 
 
 
certificates for their original validity period until at the latest 31 May 2015. At March 
2014, there are 26 MoU certificates dispatched in 6 countries (Figure 10).  

2. 

The certificates for the workshops based on national laws (ES, NL, RO).  

Figure  10:  statistics  on  the  ECM  certificates  issued  in  accordance  with  Memorandum  of 
Understanding, recognized under Regulation (EU) 445/2011 

3.3.3.   ERA supporting activities 

a) Cooperation activities of the certification bodies 

Accordingly to the article 6(4) of the ECM regulation 445/2011, in order to harmonise their 
assessment  approach,  the  ECM  certification  bodies  should  cooperate  with  each  other  both 
within the Member states and across the Union. 

To  this  aim,  ERA  organises  meetings  that  are  the  occasion  for  all  certification  bodies  to 
address  their  needs  and  feedback  on  the  implementation  of  the  regulation  445/2011  and  for 
developing common solutions to their needs. 

In 2013, 3 plenary meetings have been organized and two task forces (on the analysis of gap 
and on drafting templates for the “release to service” and “return to operation”). A seminar on 
“ECM  an  overview”  was  organized  by  ERA  in  November  2013  with  more  than  120 
participants. (ECMs, keepers, maintenance workshops, RUs, IMs, ECM certification bodies). 

b) Guidance and dissemination 

A new version of the Guide for the application of the Art 14 (a) of the Safety Directive and 
Commission Regulation (EU) No 445/2011 on a system of certification of entities in charge 
of maintenance for freight wagons was published in September 2013.  

Form  April  2012  to  December  2013,  there  were  16  dissemination  workshops  on  ECM 
organized, the attendance per workshop was approximately between 60 and 120 people.  

32 

 
 
 
 
3.4.   Further developments 

3.4.1.   Monitoring safety performance processes  

There are certain limitations to the current EU railway safety monitoring approach. It relies 
exclusively on outcome indicators, such as the number of accidents and resulting casualties. 
There  is  a  long-term  downward  trend  for  these  indicators,  with  zero  values  becoming  more 
common in some categories at country level.  Relying on these very rare occurrences alone 
can  lead  to  regulatory  planning  that  is  too  reactive  and  fails  to  capture  the  available  and 
important  information  about  underlying  safety  issues.  ERA  has  therefore  started  to  develop 
new methods for monitoring and evaluating the safety of the railway system at EU level. 

The aim of this approach is to create an overview of how the framework is functioning on a 
Member State level in order to get a better understanding of the mechanisms behind systemic 
problems  but  also  of  where  there  exists  best  practice  in  the  application  of  the  regulatory 
framework to be shared between Member States. For this purpose ERA developed a model, 
the 'regulatory monitoring matrix', which can provide a systematic overview of the situation in 
the different Member States concerning Ministry, NSA and NIB-level issues.  

The matrix uses information that is already available to ERA within its different work streams 
and  presents  it  in  a  structured  and  accessible  way.  Further  information  is  gathered  through 
interviews. The expected outcomes of the approach are more focused support to the Member 
States, more informed advice to the European Commission and better prioritization of ERA’s 
work. The approach was presented to RISC in June 2013 and a pilot (from December 2013 
until June 2014) was carried out with six voluntary Member States to develop a methodology 
and evaluate the model (BE, DK, IE, UK, NL, SE, June 2014). 

The matrix consists of elements of the Railway Safety Directive and brings an understanding 
on the capability of a Member State to deliver its main requirements. Essentially, the matrix is 
a  tool  for  a  structured  discussion  with  Member  States  and  their  authorities,  as  well  as  for 
prioritising the activities of ERA.  

The  'regulatory  monitoring  matrix'  covers  five  areas  of  effective  management  (steering, 
organising,  staffing,  performing  and  evaluating),  which  are  further  articulated  into  26  sub-
elements. For each of the sub-elements, an evaluation scheme was defined with five levels of 
performance.  The  results  can  be  analysed  both  on  a  Member  State  level  (Figure  11)  or 
aggregated (Figure 12). 

The  pilot  results  were  reported  to  the  RISC  in  June  2014.  The  European  Commission  and 
ERA  proposed  to  use  this  tool  for  a  general  assessment  of  the  effectiveness  of  safety 
management  of  the  Member  States,  starting  from  a  number  of  priority  countries  having 
significantly higher risk above the EU average (at the right in figure 6). 

The  experience  from  the  pilot  is  currently  being  used  by  ERA  to  update  the  matrix. 
Evaluations using the updated version are expected to start in September 2014. 

33 

 
 
Figure  11:  matrix  assessment  results  for  a  hypothetic  Member  State  in  a  spider-web  diagram, 
showing poor performance related to the item "Audit" and sufficient or good performance for 
the other items (level 3 or above). 

Figure 12: preliminary results for the matrix pilot phase (6 Member States).  
(3 = sufficient level of implementation) 

34 

 
 
 
3.4.2.   A Platform for European Rail Infrastructure Managers (PRIME)  

A High Level European Rail Infrastructure Managers’ Platform was launched in January 2014 
by  the  European  Commission;  it  should  help  to  enhance  the  cooperation  among  the 
infrastructure  managers  and,  among  other  objective,  assure  better  implementation  of  the 
common safety approach in the EU. 

The first meeting on 28 January 2014 allowed a profitable exchange of views on recent rail 
accidents and on which preventive measures should be considered. 

35 

 
CONCLUSIONS 

Over  the  past  5  years,  the  essential  legislative  targets  have  been  met.  The  Railway 
Interoperability and Safety Committee (RISC) held approximately 20 meetings, advising  on 
the  measures  proposed  by  the  Commission.  The  overall  legislative  framework  is  therefore 
operational despite some delays or some incorrect transposition in most Member States. 

Common safety indicators, methods and targets have been developed since the 2009 progress 
report.  These  facilitate  collection  of  information,  definition  of  risk  evaluation  /  assessment 
methods  and  instil  common  safety  levels  between  Member  States,  providing  a  framework 
aimed to harmonise the requirements across Europe for safety certification and authorisation. 
A harmonised system of certification of entities in charge of maintenance for freight wagons 
has been also established. 

Member  States  were  required  to  transpose  the  Railway  Safety  Directive  into  their  national 
legal  framework.  Without  doing  so,  safety  measures  cannot  be  consistently  applied, 
developed or improved within the European railway system. 

However,  transposition  provides  only  one  part  of  the  picture:  most  essential  is  how  the 
Railway  Safety  Directive  is  implemented,  in  particular  with  the  appropriate  allocation  of 
responsibilities  to  the  main  actors.  Member  States  should  restrain  from  diluting  the 
responsibility of the operators, e.g. adopting new national safety rules instead of encouraging 
the  railway  undertakings  to  take  risk  prevention  measures  adapted  to  their  own  specific 
situation.    Finally,  Member  States  should  ensure  a  system-based  approach,  which  includes 
granting NSAs and NIBs sufficient legal powers, duties and resources to correctly supervise 
and enforce the roles and responsibilities set out in the Railway Safety Directive. 

In general, the results of the assessment indicate that the railway safety performance remains 
acceptable at the EU level for all categories of railway users under consideration, although it 
is important that some Member States are watched more closely. Over the coming years, by 
dedicating more attention to these members, more balanced and improved overall results can 
be expected. 

Taken benefit from its ten-year experience, ERA developed a complementary framework for 
the collection, process, analysis and publication of data on safety performance related to the 
process. The European Commission and ERA proposed to use the tool developed by ERA for 
a general assessment of the railway safety in the Member States, starting from  a number of 
countries having significantly higher risk above the EU average. 

Recent initiatives from the Commission in the framework of the 4th Railway Package and the 
development of a platform for Infrastructure managers in Europe (PRIME) have real potential 
to bring further safety improvements. 

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