Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on railway safety (Recast)
Date: 2013-01-30
Institutions: European Commission
Subjects: Community certification, intra-EU transport, rail transport, safety standard, transport safety

EUROPEAN 
COMMISSION 

Brussels, 30.1.2013  
COM(2013) 31 final 

2013/0016 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on railway safety 

(Recast) 

(Text with EEA relevance) 

{SWD(2013) 8} 
{SWD(2013) 9}

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

1.1. 

Recent EU policy developments in the railway field 

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 highlight the importance of 
releasing  the  growth-creating  potential  of  a  fully  integrated  Single  Market,  including  as 
regards  network  industries1.  Furthermore,  the  Commission  Communication  on  Action  for 
Stability,  Growth  and  Jobs  adopted  on  30  May  20122  stresses  the  importance  of  reducing 
further the regulatory burden and barriers to entry in the rail sector, making therefore 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 sector3. 

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 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  Fourth  Railway  Package  in  order  to  enhance  the  quality  and  efficiency  of 
rail  services  by  removing  the  remaining  market  obstacles.  The  present  Directive  is  a 
component  of  the  Fourth  Railway  Package  focusing  on  the  removal  of  remaining 
administrative  and  technical  barriers,  in  particular  by  establishing  a  common  approach  to 
safety  and  interoperability  rules  to  increase  economies  of  scale  for  railway  undertakings 
active  across  the  EU,  decreasing  administrative  costs  and  accelerating  administrative 
procedures, as well as to avoiding disguised discrimination. 

1.2. 

Legal framework for rail safety 

In order to pursue efforts to establish a single market for rail transport services, it is necessary 
to  establish  a  common  regulatory  framework  for  railway  safety.  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  establish 
international transport operations. 

Directive  91/440/EEC,  Council  Directive  95/18/EC  of  19 June  1995  on  the  licensing  of 
railway  undertakings4  and  Directive  2001/14/EC  of  the  European  Parliament  and  of  the 

1 
2 
3 
4 

http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/ec/127599.pdf. 
COM (2012) 299 final. 
COM(2012) 259 final. 
OJ L 143, 27.6.1995, p. 70. 

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Council  of  26 February  2001  on  the  allocation  of  railway  infrastructure  capacity  and  the 
levying  of  charges  for  the  use  of  railway  infrastructure  and  safety  certification5  was  a  first 
steps  towards  regulation  of  the  European  rail  transport  market  by  opening  the  market  for 
international rail freight services. However, the provisions on safety proved to be insufficient 
and differences between safety requirements among the Member States affected the optimum 
functioning of rail transport in the EU. 

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  certification6,  represented  a  great  improvement  towards  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 on national lines their safety rules and standards based on 
national technical and operational concepts. 

1.3.  Why amend Directive 2004/49/EC? 

Article 10 (7) of Directive 2004/49/EC prescribes that ‘Before 30 April 2009 the Agency shall 
evaluate the development of safety certification and submit a report to the Commission with 
recommendations on a strategy for migration towards a single Community safety certificate’ 
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 
when it would be introduced. 

In  its  interim  report  of  2009,  the  European  Railway  Agency,  hereafter  “the  Agency”, 
explained  that  it  was  too  early  to  make  a  recommendation  and  that  more  information  was 
needed  in  order  to  ensure  an  informed  debate.  The  Agency  submitted  a  report  in  July  2012 
with a Recommendation proposing a strategy for the migration7. 

Following  the  Recommendation  of  the  Agency,  the  Commission  considers  that  the  current 
regulatory framework is sufficiently mature to migrate progressively towards a ‘single safety 
certificate’. With this objective, the role of the national safety authorities needs to be revised 
and the responsibilities reallocated between them and the Agency. 

The revision of the Railway Safety Directive is also an opportunity to adapt the text to take 
into  account  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  in  matter  of  safety.  In  the  past,  the  vertically  integrated 
railway undertakings were able to control internally the quality of all processes, such as the 
maintenance of rolling stock or loading operations. The present trend of outsourcing activities 
or  services  is  leading  to  the  emergence  of  new  actors  subject  to  increasing  economic  and 
financial  pressure,  while  internal  control  is  decreasing.  This  may  have  consequences  for 
safety,  unless  a  new  way  of  monitoring  is  established,  through  contractual  or  other 
arrangements,  to  ensure  that  risk  control  measures  are  duly  implemented  by  all  relevant 
actors. 

5 
6 
7 

OJ L 75, 15.3.2001, p. 29. 
OJ L 164, 30.4.2004, p. 44. 
Recommendation on the migration to a single EU safety certificate, ERA/REC/10/2011, 3.7.2012. 

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Another important reason for amending the text concerns the national rules addressing safety 
concerns. A Task Force on this subject was established and its findings are taken into account 
in this proposal.  

Other amendments of the text are related to: 

•  Clarification  of  existing  provisions  and  new  definitions:  aimed  to  improve  consistency 
with similar provisions used in the Directive XX on the interoperability of the rail system 
within the European Union (hereinafter the ‘Interoperability Directive’). 

•  Updates due to the evolution of the legislative framework: provisions concerning national 

rules, as well as references to comitology procedures and delegated acts. 

•  Editorial  changes:  consolidation  of  previous  amendments  in  the  text  of  the  Directive, 
renumbering of articles and annexes, elimination of obsolete provisions and references to 
other component of the Fourth Railway Package. 

2. 

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND 
IMPACT ASSESSMENTS 

DG  MOVE  prepared  an  impact  assessment  to  support  legislative  proposals  on  improving 
efficiency  and  competitiveness  of  the  Single  European  Railway  Area  in  the  field  of 
interoperability and safety. 

An  Impact  Assessment  Steering  Group  (IASG)  was  created  in  June  2011.  All  DGs  were 
invited to participate, however the main interested services are DGs ENTR, EMPL, SG, SJ, 
HR, RTD, BUDG, REGIO, ENER and ELARG. 

The Commission services have discussed the developments of Single European Railway Area 
with sector representatives on an on-going basis. In 2010-2011 it conducted also an ex post 
evaluation of Regulation 881/2004 establishing the Agency. 

In order to support the Commission in the impact assessment process, an external consultant 
was  tasked  to  prepare  an  impact  assessment  support  study  and  to  undertake  a  targeted 
consultation of stakeholders. 

The targeted consultation of interested parties started on 18 November 2011 with an internet 
survey  which  finished  on  30  December  2011.  It  was  followed  by  interviews  with  the  most 
significant stakeholders and stakeholder workshop in February 2012. 

Given the technical nature of the initiative, no public consultation was carried out. However, 
the Commission has taken care that all interested parties have been consulted in due time and 
discussions have covered all the key elements of the initiative. 

More information on the impact assessment and the results of the stakeholder consultation is 
provided in the Impact Assessment Report8. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

This section provides detailed comments and explanations concerning the significant changes 
in the text of the Directive. Editorial changes and obvious modifications are not commented. 

CHAPTER I 

8 

Commission Staff Working Document accompanying the ‘Legislative proposals to eliminate remaining 
administrative  and  technical  barriers  in  the  field  of  interoperability  and  safety  on  the  EU  railway 
market’. 

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Article 1: no comments. 

Article 2: adaptation of the scope to make it consistent with the ‘Interoperability Directive’. 

Article  3:  new  definitions  and  a  few  amendments  to  improve  consistency  with  similar 
definitions used in the Interoperability Directive. 

CHAPTER II 

Article 4: clarification on role and responsibilities of the players in the railway chain to take 
into account to recent evolution of the market and of the legal framework. 

Articles 5, 6 and 7: updates due to the evolution of the legal framework. 

Article  8:  adaptation  of  the  provisions  related  to  national  rules  to  take  into  account  the 
evolution  of  the  legal  framework  (adoption  of  TSI)  and  alignment  with  the  Interoperability 
Directive. 

Article 9: no comments. 

CHAPTER III 

Article  10:  introduction  of  the  system  of  single  safety  certificate  for  railways  undertakings 
replacing the former system of safety certificate and its two parts : ‘Part A’ and ‘Part B’. 

Article  11:  former  Article  11  adapted  to  the  process  of  move  towards  a  single  safety 
certificate taking into account the new role of the Agency. 

Article 12: former Article 11 without major changes 

Article 13: no comments. 

Article 14 and 15: re-numbering of the former Article 14a updated. 

Former Article 15: obsolete. 

CHAPTER IV 

Article  16  to  18:  amendments  taking  into  account  the  new  role  of  the  national  safety 
authorities  in  the  process  of  move  towards  a  single  safety  certificate  and  reallocation  of 
responsibilities between them and the Agency. 

CHAPTER V 

Article 19: no comments. 

Article 20: clarification stressing cooperation between the national investigation body and the 
judicial authorities in case of investigation following an accident. 

Article 21 to 25: no comments. 

CHAPTER VI 

Article  26:  new  provision  on  delegated  acts  taking  into  account  the  entry  into  force  of  the 
Treaty on the Functioning of the European Union. 

Article 27: modification of the Committee procedure taking into account the entry into force 
of the Treaty on the Functioning of the European Union. 

Article 28: former article 31 updated. 

Article 29: former article 32 without comments. 

Former article 26: obsolete 

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Former  articles  29  and  30  of  Directive  2004/49/EC  concern  amendments  to  Directives 
95/18/EC  and  2001/14/EC  respectively.  They  will  be  obsolete  when  the  Recast  of  the  First 
Railway Package repealing these two Directives will enter into force. 

Article 30: transitional provisions. 

Article 31: new article concerning the role of Agency opinions and recommendations 

Article 32: former article 33 with clarifications in matter of the transposition. 

Article 33: repeal of Directive 2004/49/EC, recasted. 

Article 34: former article 34 on entry into force, adapted. 

Article 35: former article 35 on addressees, adapted. 

ANNEX I: former ANNEX I with some adaptation. 

Former ANNEX II: obsolete, following the adaptation of the national rules. 

Former ANNEX III: obsolete, following introduction of an implementing act. 

Former  ANNEX  IV:  obsolete,  following  introduction  of  the  system  of  single  EU  safety 
certificate. 

Former ANNEX V: obsolete, following introduction of an implementing act. 

New ANNEX II: correlation table. 

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(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 

2013/0016 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on railway safety 

(Recast) 

(Text with EEA relevance) 

EN 

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THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union  establishing  the 
European Community, and in particular Article 71 ⌦ 91 ⌫ (1) thereof, 
Having regard to the proposal from the European Commission1, 

After transmission of the draft legislative act to the national Parliaments, 
Having regard to the opinion of the European Economic and Social Committee2, 
Having regard to the opinion of the Committee of the Regions3, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 1 (adapted) 

In order to pursue efforts to establish a single market for rail transport services, initiated by 
Council  Directive  91/440/EEC  of  29 July  1991  on  the  development  of  the  Community's 
railways4,  it  is  necessary  to  establish  a  common  regulatory  framework  for  railway  safety. 
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 establish international transport operations. 

(cid:216) new 

(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 certification5 have been substantially amended. Since further 
amendments are to be made, it should be recast in the interests of clarity. 

Directive  91/440/EEC,  Council  Directive  95/18/EC  of  19 June  1995  on  the  licensing  of 
railway  undertakings6  and  Directive  2001/14/EC  of  the  European  Parliament  and  of  the 
Council  of  26 February  2001  on  the  allocation  of  railway  infrastructure  capacity  and  the 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 2 (adapted) 

1 
2 
3 
4 

5 
6 

OJ C , , p.. 
OJ C , , p.. 
OJ C , , p.. 
OJ L 237, 24.8.1991, p. 25. Directive as amended by Directive 2001/12/EC of the European Parliament 
and of the Council (OJ L 75, 15.3.2001, p. 1). 
OJ L 164, 30.4.2004, p. 44. 
OJ L 143, 27.6.1995, p. 70. Directive as amended by Directive 2001/13/EC of the European Parliament 
and of the Council (OJ L 75, 15.3.2001, p. 26). 

EN 

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levying  of  charges  for  the  use  of  railway  infrastructure  and  safety  certification7  provide  the 
first steps towards regulation of the European rail transport market by opening the market for 
international  rail  freight  services.  However,  the  provisions  on  safety  have  proved  to  be 
insufficient  and  differences  between  safety  requirements  remain,  which  affect  the  optimum 
functioning of rail transport in the Community. It is of particular importance to harmonise the 
content of safety rules, safety certification of railway undertakings, the tasks and roles of the 
safety authorities and the investigation of accidents. 

(cid:216) new 

(2) 

Directive  2004/49  established  a  common  regulatory  framework  for  railway  safety, 
through harmonisation of the content of safety rules, the safety certification of railway 
undertakings, the tasks and roles of the national safety authorities and the investigation 
of  accidents.  Nevertheless,  to  pursue  efforts  to  establish  a  single  market  for  rail 
transport services, that Directive needs thorough revision. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 3 (adapted) 

Metros,  trams  and  other  light  rail  systems  are  in  many  Member  States  subject  to  local  or 
regional safety rules and are often supervised by local or regional authorities and not covered 
by the requirements on Community interoperability or licensing. Trams are furthermore often 
subject to road  safety legislation and could therefore not be fully covered by railway safety 
rules.  For  these  reasons  and  in  accordance  with  the  principle  of  subsidiarity  as  set  out  in 
Article 5 of the Treaty, Member States should be allowed to exclude such local rail systems 
from the scope of this Directive. 

(cid:216) new 

(3)  Metros, trams and other light rail systems are subject in many Member States to local 
or  regional  safety  rules  and  are  often  supervised  by  local  or  regional  authorities  and 
not  covered  by  the  requirements  for  interoperability  or  licensing  within  the  Union. 
Trams are furthermore often subject to road safety legislation and could therefore not 
be  fully  covered  by  railway  safety  rules.  For  these  reasons  such  local  rail  systems 
should  be  excluded  from  the  scope  of  this  Directive.  This  does  not  prevent  Member 
States  from  applying  the  provisions  of  this  Directive  to  local  rail  systems  on  a 
voluntary basis if they deem this appropriate. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 4 (adapted) 

Safety levels in the Community rail system are generally high, in particular compared to road 
transport.  It  is  important  that  safety  is  at  the  very  least  maintained  during  the  current 
restructuring phase, which will separate functions of previously integrated railway companies 
and  move  the  railway  sector  further  from  self-regulation  to  public  regulation.  In  line  with 

7 

OJ  L 75,  15.3.2001,  p. 29.  Directive  as  amended  by  Commission  Decision  2002/844/EC  (OJ  L 289, 
26.10.2002, p. 30). 

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technical  and  scientific  progress,  safety  should  be  further  improved,  when  reasonably 
practicable and taking into account the competitiveness of the rail transport mode. 

(4) 

Safety levels in the Union’s rail system are generally high, in particular compared to 
road transport. In line with technical and scientific progress, safety should be further 
improved,  when  reasonably  practicable  and  taking  into  account  the  expected 
improvement in the competitiveness of rail transport. 

(cid:216) new 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 

(5) 

All those operating The main actors in the railway system, infrastructure managers and 
railway undertakings, should bear the full responsibility for the safety of the system, 
each  for  their  own  part.  Whenever  it  is  appropriate,  they  should  cooperate  in 
implementing  risk  control  measures.  Member  States  should  make  a  clear  distinction 
between  this  immediate  responsibility  for  safety  and  the  ⌦ national ⌫  safety 
authorities’  task  of  providing  a  national  regulatory  framework  and  supervising  the 
performance of the all operators. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 6 (adapted) 

The  responsibility  of  infrastructure  managers  and  railway  undertakings  for  operating  the 
railway system does not preclude other actors such as manufacturers, maintenance suppliers, 
wagon keepers, service providers and procurement entities from assuming responsibility for 
their products or services in accordance with the provisions of Council Directive 96/48/EC of 
23 July  1996  on  the  interoperability  of  the  trans-European  high-speed  rail  system8  and  of 
Directive  2001/16/EC  of  the  European  Parliament  and  of  the  Council  of  19 March  2001  on 
the  interoperability  of  the  trans-European  conventional  rail  system9  or  of  other  relevant 
Community legislation. 

(cid:216) new 

(6) 

The  responsibility  of  infrastructure  managers  and  railway  undertakings  for  operating 
the  rail  system  does  not  preclude  other  actors  such  as  manufacturers,  carriers, 
consignors,  fillers,  loaders  entities  in  charge  of  maintenance,  maintenance  suppliers, 
wagon  keepers,  service  providers  and  procurement  entities  from  assuming 
responsibility for their products or services. To avoid the risk that the responsibilities 
are  not  properly  assumed,  each  relevant  actor  should  be  made  responsible  for  its 
particular process. Each actor in the rail system should be responsible in respect to the 
other  actors  for  complete  and  truthful  communication  of  all  relevant  information  to 
check if the vehicles are fit to run. In particular that concerns information on the status 
and  history  of  the  vehicle,  maintenance  files,  traceability  of  loading  operations,  and 
consignment notes. 

8 
9 

OJ L 235, 17.9.1996, p. 6. 
OJ L 110, 20.4.2001, p. 1. 

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(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 7 (adapted) 

Requirements on safety of the subsystems of the trans-European rail networks are laid down 
in  Directive  96/48/EC  and  Directive  2001/16/EC.  However,  those  Directives  do  not  define 
common  requirements  at  system  level  and  do  not  deal  in  detail  with  the  regulation, 
management  and  supervision  of  safety.  When  minimum  safety  levels  of  the  subsystems  are 
defined by technical specifications for interoperability (TSIs) it will be increasingly important 
to establish safety targets at the system level as well. 

(cid:216) new 

(7) 

Each railway undertaking, infrastructure manager and entity in charge of maintenance 
should  ensure  that  its  contractors  and  other  parties  implement  risk  control  measures. 
To  this  end,  they  should  apply  the  methods  for  monitoring  set  out  in  the  common 
safety  methods  (CSMs).  Their  contractors  should  apply  this  process  through 
contractual  arrangements.  Because  such  arrangements  are  an  essential  part  of  the 
safety  management  system  of  railway  undertakings  and  infrastructure  managers, 
railway  undertakings  and  infrastructure  managers  should  disclose  their  contractual 
arrangements on request of the European Union Agency for Railways (hereafter "the 
Agency") or the national safety authority in the context of supervision activities. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 8 (adapted) 

Common  safety  targets  (CSTs)  and  common  safety  methods  (CSMs)  should  be  gradually 
introduced to ensure that a high level of safety is maintained and, when and where necessary 
and reasonably practicable, improved. They should provide tools for assessment of the safety 
level  and  the  performance  of  the  operators  at  Community  level  as  well  as  in  the  Member 
States. 

(cid:216) new 

(8) 

Common  safety  targets  (CSTs)  and  CSMs  have  been  gradually  introduced  to  ensure 
that  safety  is  maintained  at  a  high  level  and,  when  necessary  and  where  reasonably 
practicable,  improved.  They  should  provide  tools  for  assessment  of  the  safety  and 
performance  of  operators  at  Union  level  as  well  as  in  the  Member  States.  Common 
safety  indicators  (CSIs)  have  been  established  in  order  to  assess  whether  systems 
comply with the CSTs and to facilitate the monitoring of railway safety performance. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 9 (adapted) 

Information on safety of the railway system is scarce and not generally publicly available. It is 
thus necessary to establish common safety indicators (CSIs) in order to assess that the system 
complies  with  the  CSTs  and  to  facilitate  the  monitoring  of  railway  safety  performance. 
However, national definitions relating to the CSIs may apply during a transitional period and 
due account should therefore be taken of the extent of the development of common definitions 
of the CSIs when the first set of CSTs is drafted. 

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(cid:216) new 

(9) 

National  rules,  which  are  often  based  on  national  technical  standards,  have  been 
gradually replaced by rules based on common standards, established by CSTs, CSMs 
and  technical  specifications  for  interoperability  (TSIs).  In  order  to  eliminate  the 
obstacles  to  interoperability,  the  amount  of  national  rules  should  be  reduced  as  a 
consequence of extending the scope of the TSIs to the whole Union’s rail system and 
of  closing  open  points  in  the  TSIs.  For  this  purpose  the  Member  States  should  keep 
their  system  of  national  rules  updated,  delete  obsolete  rules  and  thereof  inform  the 
Commission and the the Agency. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 10 
(adapted) 

National safety rules, which are often based on national technical standards, should gradually 
be  replaced  by  rules  based  on  common  standards,  established  by  TSIs.  The  introduction  of 
new specific national rules which are not based on such common standards should be kept to 
a  minimum.  New  national  rules  should  be  in  line  with  Community  legislation  and  facilitate 
migration  towards  a  common  approach  to  railway  safety.  All  interested  parties  should 
therefore  be  consulted  before  a  Member  State  adopts  a  national  safety  rule  that  requires  a 
higher  safety  level  than  the  CSTs.  In  such  cases  the  new  draft  rule  should  be  subject  to 
examination  by  the  Commission,  which  should  adopt  a  Decision  if  it  appears  that  the  draft 
rule  is  not  in  conformity  with  Community  legislation  or  constitutes  a  means  of  arbitrary 
discrimination or a disguised restriction on rail transport operation between Member States. 

(cid:216) new 

(10) 

In view of the gradual approach to eliminating obstacles to the interoperability of the 
rail  system  and  of  the  time  consequently  required  for  the  adoption  of  TSIs,  steps 
should be taken to avoid a situation where Member States adopt new national rules or 
undertake  projects  that  increase  the  diversity  of  the  present  system.  The  safety 
management  system  is  the  recognised  tool  for  preventing  accidents  and  railway 
undertakings  are  responsible  for  taking  immediate  corrective  action  to  prevent  re-
occurrence of accidents. Member States should not decrease the responsibility of the 
railway undertakings by establishing new national rules immediately after an accident. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 11 
(adapted) 

The  current  situation,  in  which  national  safety  rules  continue  to  play  a  role,  should  be 
regarded as a transitional stage, leading ultimately to a situation in which European rules will 
apply. 

(11) 

In carrying out their duties and fulfilling their responsibilities, infrastructure managers 
and  railway  undertakings  should  implement  a  safety  management  system  meeting 

(cid:216) new 

EN 

12 

   EN 

 
 
 
 
 
 
Union requirements and containing common elements. Information on safety and the 
implementation of the safety management system should be submitted to the Agency 
and to the national safety authority in the Member State concerned. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 12 
(adapted) 

The development of CSTs, CSMs and CSIs as well as the need to facilitate progress towards a 
common  approach  to  railway  safety  requires  technical  support  at  Community  level.  The 
European  Railway  Agency  established  by  Regulation  (EC)  No  881/2004  of  the  European 
Parliament and of the Council10 is set up to issue recommendations concerning CSTs, CSMs 
and  CSIs  and  further  harmonisation  measures  and  to  monitor  the  development  of  railway 
safety in the Community. 

(cid:216) new 

(12)  To  ensure  a  high  level  of  railway  safety  and  equal  conditions  for  all  railway 
undertakings, the latter should be subject to the same safety requirements. A licensed 
railway  undertaking  should  hold  a  safety  certificate  in  order  to  obtain  access  to  the 
railway infrastructure. The safety certificate should provide evidence that the railway 
undertaking has established its safety management system and is able to comply with 
the  relevant  safety  standards  and  rules.  For  international  transport  services,  it  should 
be enough to approve the safety management system only once at Union level. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 13 
(adapted) 

In  carrying  out  their  duties  and  fulfilling  their  responsibilities,  infrastructure  managers  and 
railway  undertakings  should  implement  a  safety  management  system,  fulfilling  Community 
requirements  and  containing  common  elements. 
the 
implementation of the safety management system should be submitted to the safety authority 
in the Member State concerned. 

Information  on  safety  and 

(cid:216) new 

(13)  Harmonised  methods  based  on  Directive  2004/49/EC  have  been  established  to  be 
applied to the railway undertakings and the national safety authorities on monitoring, 
conformity  assessment,  supervision  and  on  risk  evaluation  and  assessment.  This 
regulatory  framework  is  sufficiently  mature  to  move  progressively  towards  a  ‘single 
safety certificate’, valid throughout the Union. The move to a single safety certificate 
should  make  the  rail  system  more  effective  and  efficient  by  reducing  admistrative 
burdens for the railway undertakings. 

10 

See page 3 of this Official Journal. 

EN 

13 

   EN 

 
 
 
 
 
                                                 
(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 14 
(adapted) 

take 

that  Council 
The  safety  management  system  should 
Directive 89/391/EC  of  12 June  1989  on  the  introduction  of  measures  to  encourage 
improvements  in  the  safety  and  health  of  workers  at  work11  and  its  relevant  individual 
directives are fully applicable to the protection of the health and safety of workers engaged in 
railway  transport.  The  safety  management  system  should  also  take  account  of  Council 
Directive 96/49/EC of 23 July 1996 on the approximation of the laws of the Member States 
with regard to the transport of dangerous goods by rail12. 

into  account 

the  fact 

(cid:216) new 

(14)  The  single  safety  certificate  should  be  issued  on  the  basis  of  the  evidence  that  the 
railway  undertaking  has  established  its  safety  management  system.  Establishing  this 
evidence may require not only on-site inspections to the railway undertaking but also 
the supervision aimed to assess that the railway undertaking continues to apply duly its 
safety management system after having been granted the single safety certificate.  

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 15 
(adapted) 

To  ensure  a  high  level  of  railway  safety  and  equal  conditions  for  all  railway  undertakings, 
they  should  be  subject  to  the  same  safety  requirements.  The  safety  certificate  should  give 
evidence  that  the  railway  undertaking  has  established  its  safety  management  system  and  is 
able  to  comply  with  the  relevant  safety  standards  and  rules.  For  international  transport 
services it should be enough to approve the safety management system in one Member State 
and  give  the  approval  Community  validity.  Adherence  to  national  rules  on  the  other  hand 
should be subject to additional certification in each Member State. The ultimate aim should be 
to establish a common safety certificate with Community validity. 

(15) 

Infrastructure  manager  should  have  a  key  responsibility  for  the  safe  design, 
maintenance  and  operation  of  its  rail  network.  The  infrastructure  manager  should  be 
subject  to  safety  authorisation  by  the  national  safety  authority  concerning  its  safety 
management system and other provisions to meet safety requirements. 

(cid:216) new 

11 
12 

OJ L 183, 29.6.1989, p. 1. 
OJ L 235, 17.9.1996, p. 25. Directive as last amended by Commission Directive 2003/29/EC (OJ L 90, 
8.4.2003, p. 47). 

EN 

14 

   EN 

 
 
 
 
 
                                                 
(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 16 
(adapted) 

In  addition  to  the  safety  requirements  laid  down  in  the  safety  certificate,  licensed  railway 
undertakings must comply with national requirements, compatible with Community law and 
applied  in  a  non-discriminatory  manner,  relating  to  health,  safety  and  social  conditions, 
including legal provisions relating to driving time, and the rights of workers and consumers as 
provided for in Articles 6 and 12 of Directive 95/18/EC. 

(16)  The  certification  of  train  staff  is  often  an  insurmountable  barrier  to  new  entrants. 
Member  States  should  ensure  that  facilities  for  the  training  and  certification  of  train 
staff  necessary  to  meet  requirements  under  national  rules  are  available  to  railway 
undertakings intending to operate on the relevant network. 

(cid:216) new 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 17 
(adapted) 

Every  infrastructure  manager  has  a  key  responsibility  for  the  safe  design,  maintenance  and 
operation  of  its  rail  network.  In  parallel  to  safety  certification  of  railway  undertakings  the 
infrastructure  manager  should  be  subject  to  safety  authorisation  by  the  safety  authority 
concerning its safety management system and other provisions to meet safety requirements. 

(cid:216) new 

(17)  The entity in charge of maintenance should be certified for freight wagons. Where the 
entity in charge of maintenance is an infrastructure manager, this certification should 
be included in the procedure for safety authorisation. The certificate issued to such an 
entity should guarantee that the maintenance requirements of this Directive are met for 
any freight wagon for which the entity is in charge. This certificate should be valid in 
the whole Union and should be issued by a body able to audit the maintenance system 
set up by the entity. As freight wagons are frequently used in international traffic and 
as the entity in charge of maintenance may want to use workshops established in more 
than one Member State, the certification body should be able to implement its controls 
throughout the Union. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 18 
(adapted) 

Member States should make efforts to assist applicants wishing to enter the market as railway 
undertakings. In particular they should provide information and act promptly on requests for 
safety  certification.  For  railway  undertakings  operating  international  transport  services,  it  is 
important  for  the  procedures  to  be  similar  in  different  Member  States.  Although  the  safety 
certificate  will  contain  national  parts  for  the  foreseeable  future,  it  should  nevertheless  be 

EN 

15 

   EN 

 
 
 
 
 
 
possible  to  harmonise  the  common  parts  of  it  and  facilitate  the  creation  of  a  common 
template. 

(cid:216) new 

(18)  The national safety authorities should be fully independent in their organisation, legal 
structure and decision making from any railway undertaking, infrastructure manager, 
applicant  and  procurement  entity.  They  should  carry  out  their  tasks  in  an  open  and 
non-discriminatory way and cooperate with the Agency to create a single rail area and 
coordinate their decision-making criteria. To increase efficiency, two or more Member 
States  may  decide  to  merge  the  staff  and  resources  of  the  respective  national  safety 
authorities. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 19 
(adapted) 

Certification of train staff and authorisation of placing in service of in-use rolling stock for the 
different national networks are often insurmountable barriers to new entrants. Member States 
should ensure that facilities for the training and certification of train staff necessary to meet 
requirements under national rules are available to railway undertakings applying for a safety 
certificate. A common procedure should be established for authorisation of placing in service 
of in-use rolling stock. 

(19)  When  a  national  safety  authority  is  requested  to  supervise  a  railway  undertaking 
established  in  different  Member  States,  the  other  relevant  national  safety  authorities 
should  be  informed  by  the  Agency  and  the  latter  should  ensure  the  necessary 
coordination of supervision activities. 

(cid:216) new 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 20 
(adapted) 

Driving times and rest periods for train drivers and train staff performing safety tasks have an 
important impact on the safety level of the rail system. These aspects fall under Articles 137 
to 139 of the Treaty and are already subject to negotiations between the social partners under 
the  Sectoral  Dialogue  Committee 
accordance  with  Commission 
set  up 
Decision 98/500/EC13. 

in 

13 

Commission  Decision  98/500/EC  of  20 May  1998  on  the  establishment  of  Sectoral  Dialogue 
Committees  promoting  the  Dialogue  between  the  social  partners  at  European  level  (OJ  L 225, 
12.8.1998, p. 27). 

EN 

16 

   EN 

 
 
 
 
 
                                                 
(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 21 
(adapted) 

The  development  of  a  safe  Community  railway  system  requires  the  establishment  of 
harmonised  conditions  for  delivering  the  appropriate  licences  to  train  drivers  and  on-board 
accompanying  staff  performing  safety  tasks,  for  which  the  Commission  has  announced  its 
intention to propose further legislation in the near future. As far as other staff charged with 
safety-critical  tasks  are  concerned,  their  qualifications  are  already  being  specified  under 
Directives 96/48/EC and 2001/16/EC. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 22 
(adapted) 

As  part  of  the  new  common  regulatory  framework  for  railway  safety,  national  authorities 
should be set up in all Member States to regulate and supervise railway safety. To facilitate 
cooperation between them at Community level, they should be given the same minimum tasks 
and  responsibilities.  The  national  safety  authorities  should  be  granted  a  high  degree  of 
independence.  They  should  carry  out  their  tasks  in  an  open  and  non-discriminatory  way  to 
help  to  create  a  single  Community  rail  system  and  cooperate  to  coordinate  their  decision-
making criteria, in particular concerning safety certification of railway undertakings operating 
international transport services. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 23 
(adapted) 

(2320) Serious  accidents  on  the  railways  are  rare.  However,  they  can  have  disastrous 
consequences and raise concern among the public about the safety performance of the 
railway  system.  All  such  accidents  should,  therefore,  be  investigated  from  a  safety 
perspective  to  avoid  recurrence  and  the  results  of  the  investigations  should  be  made 
public. Other accidents and incidents ⌦ should also be subject to safety investigations 
when they ⌫ could be significant precursors to serious accidents and should also be 
subject to safety investigations, when it is necessary. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 24 
(adapted) 

(2421) A safety investigation should be kept separate from the judicial inquiry into the same 
incident and ⌦ should ⌫ be granted access to evidence and witnesses. It should be 
carried out by a permanent body that is independent of the actors of the rail sector. The 
body should function in a way which avoids any conflict of interest and any possible 
involvement  in  the  causes  of  the  occurrences  that  are  investigated;  in  particular,  its 
functional  independence  should  not  be  affected  if  it  is closely  linked  to  the  national 
safety  authority  or  regulator  of  railways  for  organisational  and  legal  structure 
purposes. Its investigations should be carried out under as much openness as possible. 

EN 

17 

   EN 

 
 
 
 
 
For each occurrence the investigation body should establish the relevant investigation 
group with necessary expertise to find the immediate causes and underlying causes. 

(cid:216) new 

(22) 

In order to improve the efficiency of activities of an investigation body and to help it 
in discharging its duties, the investigation body should have timely access to the site of 
an  accident,  where  necessary  in  good  cooperation  with  the  judicial  authority.  The 
reports  on  investigations  and  any  findings  and  recommendations  provide  crucial 
information  for  the  further  improvement  of  railway  safety  and  should  be  made 
publicly  available  at  Union  level.  Safety  recommendations  should  be  acted  upon  by 
the addressees and actions reported back to the investigating body. 

(23)  The Member States should lay down rules on penalties applicable to infringements of 
the provisions of this Directive and ensure that they are implemented. Those penalties 
should be effective, proportionate and dissuasive. 

(24)  Since  the  objectives  of  the  actions  proposed  in  this  Directive,  namely  coordinating 
activities in the Member States in order to regulate and supervise safety, investigating 
accidents and establishing common safety targets, common safety methods, common 
safety  indicators  and  common  requirements  for  single  safety  certificates  cannot  be 
sufficiently achieved by the Member States and can be better achieved at Union level, 
the Union may adopt measures in accordance with the principle of subsidiarity as set 
out in Article 5 of the Treaty on European Union. In accordance with the principle of 
proportionality,  as  set  out  in  that  Article,  this  Directive  does  not  go  beyond  what  is 
necessary in order to achieve those objectives. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 25 
(adapted) 

The  reports  on  investigations  and  any  findings  and  recommendations  provide  crucial 
information  for  the  further  improvement  of  railway  safety  and  should  be  made  publicly 
available  at  Community  level.  Safety  recommendations  should  be  acted  upon  by  the 
addressees and actions reported back to the investigating body. 

(cid:216) new 

(25) 

In order to supplement and amend certain non-essential elements of this Directive, the 
power to adopt acts in accordance with Article 290 of the Treaty should be delegated 
to  the  Commission  in  respect  of  common  safety  methods  and  their  revision,  and 
revision  of  common  safety  indicators  and  common  safety  targets.  It  is  of  particular 
importance  that  the  Commission  carry  out  appropriate  consultations  during  its 
preparatory  work,  including  at  expert  level.  The  Commission,  when  preparing  and 
drawing  up  delegated  acts,  should  ensure  a  simultaneous,  timely  and  appropriate 
transmission of relevant documents to the European Parliament and to the Council. 

(26) 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Directive,  the 
implementing  powers  should  be  conferred  on  the  Commission  relating  to  the 
requirements for the safety management system and its elements, review of the system 
for  certification  of  the  entities  in  charge  of  maintenance  for  freight  wagons  and 
extension to other rolling stocks and the principal content of the accident and incident 

EN 

18 

   EN 

 
 
 
 
investigation report. Those powers should be exercised in accordance with Regulation 
(EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 
laying  down  the  rules  and  general  principles  concerning  mechanisms  for  control  by 
Member States of the Commission’s exercise of implementing powers14. 

(27)  The obligation to transpose this Directive into national law should be confined to those 
provisions  representing  a  substantive  change  as  compared  with  the  earlier  Directive. 
The obligation to transpose the provisions that are unchanged arises under the earlier 
Directive. 

(28)  This  Directive  should  be  without  prejudice  to  the  obligation  of  the  Member  States 
relating to the time-limits for transposition into national law of the Directives set out in 
Annex IV, part B, 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 26 
(adapted) 

Since  the  objectives  of  the  proposed  action,  namely  to  coordinate  activities  in  the  Member 
States  to  regulate  and  supervise  safety  and  to  investigate  accidents  and  to  establish  at 
Community level common safety targets, common safety methods, common safety indicators 
and  common  requirements  of  safety  certificates,  cannot  be  sufficiently  achieved  by  the 
Member States and can therefore, by reason of the scale of the action, be better achieved at 
Community  level,  the  Community  may  adopt  measures  in  accordance  with  the  principle  of 
subsidiarity  as  set  out  in  Article  5  of  the  Treaty.  In  accordance  with  the  principle  of 
proportionality, as set out in that Article, this Directive does not go beyond what is necessary 
in order to achieve those objectives. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 27 
(adapted) 

The  measures  necessary  for  the  implementation  of  this  Directive  should  be  adopted  in 
accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedure 
for the exercise of implementing powers conferred on the Commission15. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 28 
(adapted) 

This Directive aims at reorganising and bringing together the relevant Community legislation 
on  railway  safety.  Consequently,  provisions  for  safety  certification  of  railway  undertakings 
that  were previously  set out in Directive 2001/14/EC should, together with  all references to 
safety  certification,  be  repealed.  Directive  95/18/EC  included  requirements  on  safety 
qualifications  of  operational  staff  and  on  safety  of  rolling  stock  that  are  covered  by  the 
requirements on safety certification of this Directive and should therefore no longer be part of 

14 
15 

OJ L 55, 28.2.2011, p. 13. 
OJ L 184, 17.7.1999, p. 23. 

EN 

19 

   EN 

 
 
 
 
                                                 
the licensing requirements. A licensed railway undertaking should hold a safety certificate in 
order to be granted access to the railway infrastructure. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 recital 29 
(adapted) 

The  Member  States  should  lay  down  rules  on  penalties  applicable  to  infringements  of  the 
provisions of this Directive and ensure that they are implemented. Those penalties should be 
effective, proportionate and dissuasive. 

HAVE ADOPTED THIS DIRECTIVE: 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 
(cid:214) new 

CHAPTER I 

GENERAL PROVISIONS 

Article 1 

Subject matter 

The  purpose  of  this  Directive  is  ⌦ This  Directive  lays  down  provisions ⌫  to  ensure  the 
development  and  improvement  of  safety  of  the  Community's  ⌦ Union’s ⌫  railways  and 
improved access to the market for rail transport services by: 

(a) harmonising the regulatory structure in the Member States; 

(b) defining responsibilities between the actors ⌦ of the rail system ⌫ ; 

(c)  developing  common  safety  targets  and  common  safety  methods  with  a  view  to 
greater harmonisation of (cid:214) gradually removing the need for  national rules; 

(d)  requiring  the  establishment,  in  every  (cid:214) for  each   Member  State,  of  a 
⌦ national ⌫ safety authority and an accident and incident investigating body; 

(e)  defining  common  principles  for  the  management,  regulation  and  supervision  of 
railway safety. 

Article 2 

Scope 

1. This Directive applies to the ⌦ rail ⌫ railway system in the Member States, which may 
be  broken  down  into  subsystems  for  structural  and  operational  (cid:214) functional   areas.  It 
covers  safety  requirements  on  the  system  as  a  whole,  including  the  safe  management  of 
infrastructure and of traffic operation and the interaction between railway undertakings (cid:214) ,  
and infrastructure managers (cid:214) and other actors of the rail system . 

2. (cid:214) The following systems are excluded from the scope of this Directive:  

Member  States  may  exclude  from  the  measures  they  adopt  in  implementation  of  this 
Directive: 

EN 

20 

   EN 

 
 
 
 
 
 
 
 
(a) metros, trams and other light rail systems; 

(b)  networks  that  are  functionally  separate  from  the  rest  of  the  rail  ⌦ railway ⌫ 
system  and  intended  only  for  the  operation  of  local,  urban  or  suburban  passenger 
services, as well as railway undertakings operating solely on these networks; 

⌦ 3.  Member  States  may  exclude  from  the  scope  of  the  measures  implementing  this 
Directive: ⌫ 

(ac) privately owned railway infrastructure (cid:214) and vehicles exclusively used on such 
infrastructure where  this   exists  solely  for  use  by  the  infrastructure  owner  for  its 
own freight operations; 

(cid:214) (b)  infrastructure  and  vehicles  reserved  for  strictly  local,  historical  or  tourist 
use.  

(cid:208) 2008/110/EC Art. 1.1 

(d)  heritage  vehicles  that  run  on  national  networks  provided  that  they  comply  with 
national safety rules and regulations with a view to ensuring safe circulation of such 
vehicles; 

(e)  heritage,  museum  and  tourist  railways  that  operate  on  their  own  network, 
including workshops, vehicles and staff. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 

Article 3 

Definitions 

For the purpose of this Directive, the following definitions shall apply: 

(a)‘railway  system’  means  the  totality  of  the  subsystems  for  structural  and 
operational areas, as defined in Directives 96/48/EC and 2001/16/EC, as well as the 
management and operation of the system as a whole;  

(a) ‘rail system’ means the Union rail system as defined in Article 2 of Directive [xx 
on interoperability of the rail system]; 

(cid:216) new 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 

(b)‘infrastructure  manager’  means  any  body  or  undertaking  that  is  responsible  in 
particular for establishing and maintaining railway infrastructure, or a part thereof, as 
defined  in  Article  3  of  Directive  91/440/EEC,  which  may  also  include  the 
management  of  infrastructure  control  and  safety  systems.  The  functions  of  the 
infrastructure  manager  on  a  network  or  part  of  a  network  may  be  allocated  to 
different bodies or undertakings; 

EN 

21 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
(b)‘infrastructure manager’  means infrastructure manager as defined in Article 2 of 
Directive 2001/14/EC16; 

(cid:216) new 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 
(cid:214) new 

(c)‘railway undertaking’ means railway undertaking as defined in (cid:214) Article 2 of  
Directive  2001/14/EC,  and  any  other  public  or  private  undertaking,  the  activity  of 
which is to provide transport of goods and/or passengers by rail on the basis that the 
undertaking must ensure traction,including undertakings which provide traction only; 

(d)‘technical  specification  for  interoperability  (TSI)’  means  a  the  specifications  by 
which each subsystem or part of a subsystem is covered in order to meet the essential 
requirements  and  ensure  the  interoperability  of  the  trans-European  high-speed  and 
conventional  the  rail  systems  system  as  defined  in  (cid:214) Article  2  of Directive  xx 
Directive  96/48/EC  and  Directive  2001/16/EC;  (cid:214) on  interoperability  of  the  rail 
system;  

(e)‘common  safety  targets  (CSTs)’  means  the  safety  levels  that  must  at  least  be 
reached by different parts of the rail system (such as the conventional rail system, the 
high speed rail system, long railway tunnels or lines solely used for freight transport) 
and by the system as a whole, expressed in risk acceptance criteria; 

(f)‘common safety methods (CSMs)’ means the methods to be developed to describe 
how safety levels and achievement of safety targets and compliance with other safety 
requirements are assessed; 

⌦ (f)‘common  safety  methods  (CSMs)’  means  the  methods  describing  the 
assessment  of  safety  levels  and  achievement  of  safety  targets  and  compliance  with 
other safety requirements; ⌫ 

(g)‘  ⌦ national ⌫  safety  authority’  means  the  national  body  entrusted  with  the 
tasks  regarding  railway  safety  in  accordance  with  this  Directive  or  any  binational 
body entrusted by ⌦ several ⌫ Member States with these tasks in order to ensure a 
unified safety regime for specialised cross-border infrastructures; 

(h)‘national  safety  rules’  means  all  (cid:214) binding   rules  containing  railway  safety 
(cid:214) or  technical   requirements  imposed  at  Member  State  level  and  applicable  to 
more  than  one  railway  undertaking  (cid:214) undertakings   ,  irrespective  of  the  body 
issuing them; 

(i)‘safety management system’ means the organisation and arrangements established 
by an infrastructure manager or a railway undertaking to ensure the safe management 
of its operations; 

(j)‘investigator-in-charge’  means  a  person  responsible  for  the  organisation,  conduct 
and control of an investigation; 

16 

OJ L 75, 15.3.2001, p. 29 

EN 

22 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
(k)‘accident’ means an unwanted or unintended sudden event or a specific chain of 
such  events  which  have  harmful  consequences;  accidents  are  divided  into  the 
following  categories:  collisions,  derailments,  level-crossing  accidents,  accidents  to 
persons caused by rolling stock in motion, fires and others; 

(l)‘serious accident’ means any train collision or derailment of trains, resulting in the 
death of at least one person or serious injuries to five or more persons or extensive 
damage to rolling stock, the infrastructure or the environment, and any other similar 
accident with an obvious impact on railway safety regulation or the management of 
safety;  ‘extensive  damage’  ⌦ above ⌫  means  damage  that  can  immediately  be 
assessed by the investigating body to cost at least EUR 2 million in total; 

(m)‘incident’  means  any  occurrence,  other  than  accident  or  serious  accident, 
associated  with  the  operation  of  trains  and  affecting  the  safety  of  operation 
⌦ operations ⌫; 

(n)‘investigation’ means a process conducted for the purpose of accident and incident 
prevention which includes the gathering and analysis of information, the drawing of 
conclusions,  including  the  determination  of  causes  and,  when  appropriate,  the 
making of safety recommendations; 

(o)‘causes’ means actions, omissions, events or conditions, or a combination thereof, 
which led to the accident or incident; 

(p)‘Agency’  means  the  European  Railway  Agency,  the  Community  agency  for 
railway safety and interoperability; 

(cid:216) new 

(p)‘light  rail’  means  an  urban  and/or  sub-urban  rail  transport  system  with  lower 
capacity and lower speeds than heavy rail and metro systems, but higher capacity and 
higher speeds than tram systems. Light rail systems may have their own right-of-way 
or share it with road traffic and usually do not exchange vehicles with long-distance 
passenger or freight traffic; 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 
(cid:214) new 

(q)‘notified  bodies’  means  the  bodies  which  are  responsible  for  assessing  the 
conformity or suitability for use of the interoperability constituents or for appraising 
the  EC  ‘EC’  procedure  for  verification  of  the  subsystems,  as  defined  in  Directives 
96/48/EC and 2001/16/EC; 

(r)‘interoperability  constituents’  means  any  elementary  component,  group  of 
components,  subassembly  or  complete  assembly  of  equipment  incorporated  or 
intended to be incorporated into a subsystem upon which the interoperability of the 
high-speed  or  conventional  rail  system  depends  directly  or  indirectly,  as  defined  in 
(cid:214) Article  2  of  Directive  xx  on  interoperability  of  the  rail  system   Directive 
96/48/EC  and 2001/16/EC.  The  concept  of  a  ‘constituent’  covers  both  tangible 
objects and intangible objects such as software; 

EN 

23 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
(cid:208) 2008/110/EC Art. 1.2 (adapted) 
(cid:214) new 

(s)‘keeper’ means the person or entity that, being the owner of a vehicle or having 
the  right  to  use  it,  exploits  the  vehicle  as  a  means  of  transport  and  is  registered  as 
such  in  the  National  Vehicle  Register  (cid:214) national  vehicle  register  referred  to  
(NVR)  provided  for  in  Article  33  of  Directive  2008/57/EC  of  the  European 
Parliament  and  of  the  Council  of  17  June  2008  ⌦ in  Article  43  of  Directive  XX 
on ⌫  the  interoperability  of  the  rail  system  within  the  Community  (recast)17, 
(hereinafter referred to as the ‘Railway Interoperability Directive’); 

(t)‘entity  in  charge  of  maintenance’  means  an  entity  in  charge  of  maintenance  of  a 
vehicle, and registered as such in the ⌦ national vehicle register ⌫ NVR; 

(u)‘vehicle’  means  a  railway  vehicle  suitable  for  circulation  on  its  own  wheels  on 
railway  lines,  with  or  without  traction  (cid:214) in  a  fixed  or  variable  composition   .  A 
vehicle is composed of one or more structural and functional subsystems or parts of 
such subsystems;. 

(cid:216) new 

(v)‘manufacturer’  means  any  natural  or  legal  person  who  manufactures  an 
interoperability  constituent  or  subsystem  or  has  it  designed  or  manufactured,  and 
markets it under his name or trademark; 

(w)‘consignor’ means the enterprise which consigns goods either on its own behalf 
or for a third party;  

(x)‘loader’  means  any  enterprise  that  loads  packaged  goods,  including  dangerous 
goods, small containers or portable tanks onto a wagon or a container or which loads 
a  container,  bulk-container,  multiple-element  gas  container,  tank-container  or 
portable tank onto a wagon; 

(y)‘filler’ means any enterprise that loads goods, including dangerous goods, into a 
tank  (tank-wagon,  wagon  with  demountable  tank,  portable  tank  or  tank-container) 
into a wagon, large container or small container for carriage in bulk, or into a battery-
wagon or multiple-element gas container. 

17 

OJ L 191, 18.7.2008, p. 1. 

EN 

24 

   EN 

 
 
 
 
 
 
 
 
 
 
                                                 
(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 
(cid:214) new 

CHAPTER II 

DEVELOPMENT AND MANAGEMENT OF SAFETY 

Article 4 

(cid:214) Role of the actors of the rail system in developing and improving  
Development and improvement of railway safety 

1.  Member  States  (cid:214) and  the  Agency   shall  ensure  that  railway  safety  is  generally 
maintained  and,  where  reasonably  practicable,  continuously 
into 
consideration  the  development  of  Community  ⌦ Union  ⌫  legislation  and  technical  and 
scientific progress and giving priority to the prevention of serious accidents. 

improved, 

taking 

Member States shall ensure that safety rules are laid down, applied and enforced in an open 
and non-discriminatory manner, fostering the development of a single European rail transport 
system. 

2.  Member  States  shall  ensure  that  measures  to  develop  and  improve  railway  safety  take 
account of the need for a system-based approach. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 
(cid:206)1 2008/110/EC Art. 1.3 
(cid:214) new 

2.  Member  States  shall  ensure  that  the  responsibility  for  the  safe  operation  of  the  railway 
system and the control of risks associated with it is laid upon the infrastructure managers and 
railway undertakings, obliging them: 

a) 

b) 

c) 

implement  necessary  risk  control  measures,  where  appropriate 

to 
cooperation with each other,  

in 

to apply ⌦ Union and ⌫ national safety rules and standards, 

to establish safety management systems in accordance with this Directive. 

Without prejudice to civil liability in accordance with the legal requirements of the Member 
States, each infrastructure manager and railway undertaking shall be made responsible for its 
part  of  the  system  and  its  safe  operation,  including  supply  of  material  and  contracting  of 
services,  vis-à-vis  users,  customers,  the  workers  concerned  and  third  parties.  (cid:214) The  risks 
associated  with  the  activities  of  third  parties  shall  also  be  taken  into  account  in  the  safety 
management systems of infrastructure managers and railway undertakings.  

34.  This  shall  be  without  prejudice  to  the  responsibility  of  each ⌦ Each ⌫  manufacturer, 
maintenance supplier, (cid:206)1 keeper  , service provider and procurement entity to ⌦ shall ⌫ 
ensure  that  rolling  stock,  installations,  accessories  and  equipment  and  services  supplied  by 
them comply with the specified requirements and the conditions for use specified, so that they 
can be safely put into operation by the railway undertaking and/or infrastructure manager. 

EN 

25 

   EN 

 
 
 
(cid:216) new 

4.  All  actors  having  a  relevant  role  in  safety  operations  shall  implement  the  necessary  risk 
control  measures,  where  appropriate  in  cooperation  with  the  others.  In  addition  to  railway 
undertakings and infrastructure managers those actors include: 

(a) 

(b) 

(c) 

the entities in charge of the maintenance of vehicles; 

the  consignors,  the  loaders  and  the  fillers,  which  have  a  role  in  safe  loading 
operations, 

the manufacturers, which are responsible for the design and manufacturing of 
safe railway vehicles, parts, components or sub-assemblies of vehicle, railway 
infrastructure, energy and track side control command, as well as issuing of the 
preliminary maintenance documentation associated to the vehicle. 

5. Each railway undertaking, infrastructure manager and entity in charge of maintenance shall 
ensure  that  its  contractors  implement  risk  control  measures.  To  this  end,  each  railway 
undertaking,  infrastructure  manager  and  entity  in  charge  of  maintenance  shall  apply  the 
common methods for monitoring processes set out in the Regulation (EU) 1078/201218. Their 
contractors shall apply this process through contractual arrangements. Railway undertakings, 
infrastructure managers and entities in charge of maintenance shall disclose their contractual 
arrangements on request of the Agency or the national safety authority. 

6. Any actor of the rail system who identifies a safety risk related to defects and construction 
non-conformities  or  malfunctions  of  technical  equipment,  including  those  of  structural  sub-
systems,  shall  report  those  risks  to  the  other  parties  involved  to  enable  them  to  take  any 
necessary  corrective  actions  to  ensure  continuous  achievement  of  the  safety  performance  of 
the rail system. 

7. In case of exchange of vehicles between railways undertakings, all actors shall exchange all 
information  relevant  to  safe  operation.  Such  information  shall  include  information  on  the 
status  and  history  of  the  vehicle,  elements  of  the  maintenance  files,  traceability  of  loading 
operations, and consignment notes. It shall be sufficiently detailed to allow an assessment of 
the risks of operating the vehicle by the railway undertaking. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 

Article 5 

Common safety indicators 

1. In order to facilitate the assessment of the achievement of the CST and to provide for the 
monitoring  of  the  general  development  of  railway  safety  Member  States  shall  collect 
information  on  common  safety  indicators  (CSIs)  through  the  annual  reports  of  the  national 
safety authorities as referred to in Article 18. 

The  first  reference  year  for  the  CSIs  shall  be  2006;  they  shall  be  reported  on  in  the  annual 
report the following year. 

The CSIs shall be established as set out in Annex I. 

18 

OJ L 320, 17.11.2012, p. 8. 

EN 

26 

   EN 

 
 
 
                                                 
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 26 
concerning the revision of Annex I, in particular to update the CSIs taking into account of the 
technical progress and to adapt the common methods for calculating accident costs. 

(cid:216) new 

2.  Before  30  April  2009  Annex  I  shall  be  revised,  in  particular  to  incorporate  therein  the 
common definitions of the CSIs and the common methods for calculating accident costs. This 
measure,  designed  to  amend  non-essential  elements  of  this  Directive,  shall  be  adopted  in 
accordance with the regulatory procedure with scrutiny referred to in Article 27(2a). 

(cid:208) 2008/110/EC Art. 1.4 (adapted) 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 

Article 6 

Common safety methods 

(cid:208) 2008/110/EC Art. 1.5(a) 
(adapted) 

1. An initial series of CSMs covering, as a minimum, the methods described in paragraph 3(a) 
shall  be  adopted  by  the  Commission  before  30  April  2008.  They  shall  be  published  in  the 
Official Journal of the European Union. 

A second series of CSMs covering the remaining methods described in paragraph 3 shall be 
adopted  by  the  Commission  before  30  April  2010.  They  shall  be  published  in  the  Official 
Journal of the European Union. 

These  measures,  designed 
this  Directive  by 
supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny 
referred to in Article 27(2a). 

to  amend  non-essential  elements  of 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 
(cid:214) new 

2.  Draft  CSMs  and  draft  revised  CSMs  shall  be  drawn  up  by  the  Agency  under  mandates 
which shall be adopted in accordance with the procedure referred to in Article 27(2). 

The draft CSMs shall be based on an examination of existing methods in the Member States. 

31.  The  CSMs  shall  describe  how  the  safety  level  ⌦ levels ⌫  ,  and  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  in  safety  certificates  and 
safety authorisations issued in accordance with Articles 10 and 11, 

EN 

27 

   EN 

 
 
 
 
 
 
 
 
and 

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

(cid:208) 2008/110/EC Art. 1.5(b) 

(cid:216) new 

(c) methods for supervision to be applied by national safety authorities and methods 
for  monitoring  to  be  applied  by  railway  undertakings,  infrastructure  managers  and 
entities in charge of maintenance; 

(d)  any  other  methods  covering  a  process  of  the  safety  management  system  which 
need to be harmonised at Union level. 

(cid:208) 2008/110/EC Art. 1.5(c) 

4. The CSMs shall 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 as laid down in Article 4(1). This measure, designed to amend non-essential 
implement  elements  of  this  Directive,  inter  alia,  by  supplementing  it,  shall  be  adopted  in 
accordance  with  the  regulatory examination procedure  with  scrutiny  referred  to  in  Article 
27(2a). 

(cid:216) new 

2.  The  Commission  shall  issue  mandates  to  the  Agency  to  draft  the  new  CSMs  referred  in 
point 1(d), to review and update all CSMs to take account of developments in technology or 
social requirements and to make the relevant recommendations to the Commission. 

When  drafting  the  recommandations,  the  Agency  shall  take  account  of  the  opinion  of  the 
users  and  of  the  stakeholders.  The  recommendations  shall  enclose  a  report  on  the  results  of 
this consultation and a report assessing the impact of the new CSM to be adopted. 

3. The CSMs shall be revised at regular intervals, taking into account the experience gained 
from their application and the global development of railway safety and in view of generally 
maintaining and where reasonably praticable, continuously improving safety. 

4.  The  Commission  shall  be  empowered  to  adopt  delegated  acts  laying  down  CSMs  and 
revised CSMs in accordance with Article 26. 

5. Member States shall make any necessary amendments to their national safety rules in the 
light of the adoption of CSMs and revisions to them. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 

Article 7 

Common safety targets 

EN 

28 

   EN 

 
 
 
 
 
 
 
 
 
 
1. The CSTs shall be developed, adopted and revised following the procedures laid down in 
this Article. 

2. Draft CSTs and draft revised CSTs shall be drawn up by the Agency under mandates which 
shall be adopted in accordance with the procedure referred to in Article 27(2). 

(cid:208) 2008/110/EC Art. 1.6(a) 
(adapted) 

3.The first set of draft CSTs shall be based on an examination of existing targets and safety 
performance in the Member States and shall ensure that the current safety performance of the 
rail system is not reduced in any Member State. It shall be adopted by the Commission before 
30  April  2009  and  shall  be  published  in  the  Official  Journal  of  the  European  Union.  This 
measure,  designed  to  amend  non-essential  elements  of  this  Directive,  inter  alia,  by 
supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny 
referred to in Article 27(2a). 

The  second  set  of  draft  CSTs  shall  be  based  on  the  experience  gained  from  the  first  set  of 
CSTs  and  their  implementation.  It  shall  reflect  any  priority  areas  where  safety  needs  to  be 
further improved. It shall be adopted by the Commission before 30 April 2011 and shall be 
published  in  the  Official  Journal  of  the  European  Union.  This  measure,  designed  to  amend 
non-essential  elements  of  this  Directive,  inter  alia,  by  supplementing  it,  shall  be  adopted  in 
accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).  

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 

1.4. The CSTs shall define the ⌦ minimum ⌫ safety levels that must at least ⌦ shall ⌫ 
be  reached  by  different  parts  of  the  railway  system  and  by  the  system  as  a  whole  in  each 
Member State, expressed in risk acceptance criteria for: 

(a) 

individual risks relating to passengers, staff including the staff of contractors, 
level crossing users and others, and, without prejudice to existing national and 
international liability rules, individual risks relating to unauthorised persons on 
railway premises; 

(b) 

societal risks. 

(cid:216) new 

2. The Commission shall issue a mandate to the Agency to draft revised CSTs and to make 
the relevant recommendations to the Commission. 

3. The CSTs shall be revised at regular intervals, taking into account the global development 
of railway safety. The revised CSTs shall reflect any priority areas where safety needs to be 
further improved. 

4. The Commission shall be empowered to adopt delegated acts laying down revised CSTs in 
accordance with Article 26. 

EN 

29 

   EN 

 
 
 
 
(cid:208) 2008/110/EC Art. 1.6(b) 
(adapted) 

5. The CSTs shall be revised at regular intervals, taking into account the global development 
of railway safety. This measure, designed to amend non-essential elements of this Directive, 
inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure 
with scrutiny referred to in Article 27(2a). 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 

5.6  Member  States  shall  make  any  necessary  amendments  to  their  national  safety  rules  in 
order  to  achieve  at  least  the  CSTs,  and  any  revised  CSTs,  in  accordance  with  the 
implementation timetables attached to them. They shall notify these rules to the Commission 
in accordance with Article 8(3). 

Article 8 

National safety rules 

In  application  of  this  Directive,  Member  States  shall  establish  binding  national  safety  rules 
and  shall  ensure  that  they  are  published  and  made  available  to  all  infrastructure  managers, 
railway  undertakings,  applicants  for  a  safety  certificate  and  applicants  for  a  safety 
authorisation in clear language that can be understood by the parties concerned.  

(cid:216) new 

1. Member States may lay down new national rules only in the following cases: 

(a)  where rules concerning existing safety methods are not covered by a CSM; 

(b) 

as an urgent preventive measure, in particular following an accident. 

Member  States  shall  ensure  that  national  rules  take  account  of  the  need  for  a  system-based 
approach. 

2. If a Member State intends to introduce a new national rule, it shall notify the draft of that 
rule to the Agency and the Commission using the appropriate IT system in accordance with 
article 23 of Regulation (EU) No …/… [Agency Regulation]. 

3. If the Agency becomes aware of any national rule notified or not which that has become 
redundant  or  is  in  conflict  with  the  CSMs  or  any  other  Union  legislation  adopted  after  the 
application of the national rule the procedure established in article 22 of Regulation (EU) No 
…/… [Agency Regulation] shall apply. 

4. Member States shall ensure that national rules are made available free of charge and in a 
language that can be understood by all parties concerned. 

5.  National  rules  notified  in  accordance  with  this  Article  are  not  subject  to  the  notification 
procedure set out in Directive 98/34/EC. 

EN 

30 

   EN 

 
 
 
 
(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 

2.  Before  30 April  2005  Member  States  shall  notify  the  Commission  of  all  the  relevant 
national safety rules in force, as set out in Annex II, and indicate their area of application. 

The  notification  shall  further  provide  information  on  the  principal  content  of  the  rules  with 
references to the legal texts, on the form of legislation and on which body or organisation is 
responsible for its publication. 

3.  Not  later  than  four  years  after  the  entry  into  force  of  this  Directive,  the  Agency  shall 
evaluate  the  way  in  which  national  safety  rules  are  published  and  made  available  in 
accordance  with  paragraph 1.  It  shall  also  make  appropriate  recommendations  to  the 
Commission for the publication of such rules in order to make the relevant information more 
easily accessible. 

4.  Member  States  shall  forthwith  notify  the  Commission  of  any  amendment  to  the  notified 
national safety rules and of any new such rule that might be adopted, unless the rule is wholly 
relating to the implementation of TSIs.  

5.  In  order  to  keep  the  introduction  of  new  specific  national  rules  to  a  minimum  and  thus 
prevent further barriers from being created, and with a view to the gradual harmonisation of 
safety rules, the Commission shall monitor the introduction of new national rules by Member 
States. 

6. If, after the adoption of CSTs, a Member State intends to introduce a new national safety 
rule  which  requires  a  higher  safety  level  than  the  CSTs,  or  if  a  Member  State  intends  to 
introduce  a  new  national  safety  rule  which  may  affect  operations  of  railway  undertakings 
from other Member States on the territory of the Member State concerned, the Member State 
shall consult all interested parties in due time and the procedure in paragraph 7 shall apply. 

7.  The  Member  State  shall  submit  the  draft  safety  rule  to  the  Commission  for  examination, 
stating the reasons for introducing it. 

If  the  Commission  finds  that  the  draft  safety  rule  is  incompatible  with  the  CSMs  or  with 
achieving  at  least  the  CSTs,  or  that  it  constitutes  a  means  of  arbitrary  discrimination  or  a 
disguised  restriction  on  rail  transport  operations  between  Member  States,  a  Decision, 
addressed to the Member State concerned, shall be adopted in accordance with the procedure 
referred to in Article 27(2). 

If the Commission has serious doubts as to the compatibility of the draft safety rule with the 
CSMs or with achieving at least the CSTs, or considers that it constitutes a means of arbitrary 
discrimination or a disguised restriction on rail transport operations between Member States, 
the Commission shall immediately inform the Member State concerned, which shall suspend 
the adoption, entry into force or implementation of the rule until a Decision is adopted, within 
a period of six months, in accordance with the procedure referred to in Article 27(2). 

Article 9 

Safety management systems 

1. Infrastructure managers and railway undertakings shall establish their safety management 
systems to ensure that the railway system can achieve at least the CSTs, is in conformity with 
the national safety rules described in Article 8 and Annex II and with safety requirements laid 

EN 

31 

   EN 

 
 
down  in  the  TSIs,  and that the  relevant  parts  of  CSMs  ⌦ and  rules  notified  under  Article 
8 ⌫ are applied. 

2. The safety management system shall meet the requirements and contain the elements laid 
down  in  Annex  III,  adapted  to  the  character,  extent  and  other  conditions  of  the  activity 
pursued. It shall ensure the control of all risks associated with the activity of the infrastructure 
manager  or  railway  undertaking,  including  the  supply  of  maintenance  and  material  and  the 
use of contractors. Without prejudice to existing national and international liability rules, the 
safety management system shall also take into account, where appropriate and reasonable, the 
risks arising as a result of activities by other parties. 

The  Commission  shall  establish,  by  means  of  implementing  acts,  elements  of  the  safety 
management  system.  Those  implementing  acts  shall  be  adopted  in  accordance  with  the 
examination procedure referred to in Article 27(2). 

(cid:216) new 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 

3.  The  safety  management  system  of  any  infrastructure  manager  shall  take  into  account  the 
effects of operations by different railway undertakings on the network and make provisions to 
allow  all  railway  undertakings  to  operate  in  accordance  with  TSIs  and  national  safety  rules 
and  with  ⌦ the ⌫  conditions  laid  down  in  their  safety  certificate.  It  shall  furthermore 
⌦ The safety management systems shall ⌫ be developed with the aim of coordinating the 
emergency procedures of the infrastructure manager with all railway undertakings that operate 
on its infrastructure. 

4.  Each  year  all  infrastructure  managers  and  railway  undertakings  shall  submit  to  the 
⌦ national ⌫  safety  authority  before  30 June  an  annual  safety  report  concerning  the 
preceding calendar year. The safety report shall contain: 

(a) 

(b) 

information  on  how  the  organisation's  organisation’s  corporate  safety  targets 
are met and the results of safety plans; 

the  development  of  national  safety  indicators,  and  of  the  CSIs  laid  down  in 
Annex I, as far as it is relevant to the reporting organisation; 

(c) 

the results of internal safety auditing; 

(d)  observations  on  deficiencies  and  malfunctions  of  railway  operations  and 
infrastructure management that might be relevant for the ⌦ national ⌫ safety 
authority. 

EN 

32 

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(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 
(cid:214) new 

CHAPTER III 

SAFETY CERTIFICATION AND AUTHORISATION 

Article 10 

Safety certificates (cid:214) Single safety certificate  

(cid:216) new 

1.  Access  to  the  railway  infrastructure  shall  be  granted  only  to  railway  undertakings  which 
hold the single safety certificate. 

2.  The  single  safety  certificate  shall  be  granted  by  the  Agency  on  the  basis  of  the  evidence 
that the railway undertaking has established its safety management system in accordance with 
Article  9  and  meets  the  requirements  laid  down  in  TSIs  and  in  other  relevant  legislation  in 
order to control risks and provide transport services safely on the network. 

3.  The  single  safety  certificate  shall  specify  the  type  and  extent  of  the  railway  operations 
covered. It shall be valid throughout the Union for equivalent operations. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 

1. In order to be granted access to the railway infrastructure, a railway undertaking must hold 
a safety certificate as provided for in this Chapter. The safety certificate may cover the whole 
railway network of a Member State or only a defined part thereof. 

The purpose of the safety certificate is to provide evidence that the railway undertaking has 
established its safety management system and can meet the requirements laid down in TSIs, 
and other relevant Community legislation and in national safety rules in order to control risks 
and provide transport services safely on the network. 

(cid:208) 2008/110/EC Art. 1.7(a) 

2. The safety certificate shall comprise:  

(a)  certification  confirming  acceptance  of  the  railway  undertaking's  safety  management 
system as described in Article 9 and Annex III, 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 

and 

EN 

33 

   EN 

 
 
 
 
 
 
(cid:208) 2008/110/EC Art. 1.7(b) 

(b) 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.  These  requirements  may  concern  the  application  of  the  TSIs  and  national  safety 
rules, including the network operating rules, acceptance of staff certificates and authorisation 
to  operate  vehicles  used  by  railway  undertakings.  The  certification  shall  be  based  on 
documentation submitted by the railway undertaking as described in Annex IV. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 

3. The safety authority in the Member State where the railway undertaking first establishes its 
operation shall grant the certification in accordance with paragraph 2. 

The certification granted in accordance with paragraph 2 must specify the type and extent of 
the  railway  operations  covered.  The  certification  granted  in  accordance  with  paragraph  2(a) 
shall be valid throughout the Community for equivalent rail transport operations.  

4. The safety authority in the Member State in which the railway undertaking is planning to 
operate  additional  rail  transport  services  shall  grant  the  additional  national  certification 
necessary in accordance with paragraph 2(b).  

4.  Three  months  before  the  start  of  operation  of  any  new  service,  the  railway  undertaking 
shall notify to the relevant national safety authority the documentation confirming that: 

(cid:216) new 

(a) 

(b) 

(c) 

(d) 

(e) 

the railway undertaking will follow the operating rules, including national rules 
made available to them in accordance with Article 8(4), and assess the safety of 
their  operation, 
in  Commission 
Regulation (EC) No 352/200919 and ensuring that they are managing all risks 
through their safety management system and that they are making all necessary 
arrangements to operate safely; 

the  requirements 

into  account 

taking 

the railway undertaking has made the arrangements necessary for cooperation 
and coordination with the infrastructure manager(s) of the network(s) where it 
proposes to operate; 

the  railway  undertaking  has  taken  any  action  necessary  to  ensure  the  safe 
operation of the service; 

the  railway  undertaking  has  a  licence  issued  in  accordance  with  Council 
Directive 95/18/EC20; 

the type and extent of its intended operation corresponds to that specified in its 
single safety certificate. 

If the national safety authority has doubts concerning the fulfilment of one or more conditions 
it shall request more information from the railway undertaking. However, this exchange may 

19 
20 

OJ L 108, 29.4.2009, p. 4. 
OJ L 143, 27.6.1995, p. 70. 

EN 

34 

   EN 

 
 
 
 
                                                 
not  have  any  suspensive  or  delaying  effect  on  the  start  of  operation.  If  the  national  safety 
authority finds evidence that one or more conditions are not met, it shall refer the matter to the 
Agency, which shall take the appropriate measures, including revocation of the certificate. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 
(cid:214) new 

5. The single safety certificate shall be renewed upon application by the railway undertaking 
at intervals not exceeding five years. It shall be wholly or partly updated whenever the type or 
extent of the operation is substantially altered. 

The  holder  of  the  single  safety  certificate  shall  without  delay  inform  the  (cid:214) Agency  
competent  safety  authority  without  delay  of  all  any  major  changes  in  the  conditions  of  the 
relevant  part  of  the  single  safety  certificate.  It  shall  furthermore  notify  the  (cid:214) Agency  
competent safety authority whenever new categories of staff or new types of rolling stock are 
introduced. 

The  (cid:214) Agency   safety  authority  may  require  that  the  relevant  part  of  the  single  safety 
certificate  be  revised  following  substantial  changes  (cid:214) to   in  the  safety  regulatory 
framework. 

6. If the safety authority finds that the holder of the safety certificate no longer satisfies the 
conditions  for  a  certification  which  it  has  issued,  it  shall  revoke  part  (a)  and/or  (b)  of  the 
certificate, giving reasons for its decision. The safety authority that has revoked an additional 
national certification granted in accordance with paragraph 4 shall promptly inform the safety 
authority that granted the certification under paragraph 2(a) of its decision. 

Similarly, a safety authority must revoke a safety certificate if it is apparent that the holder of 
the safety certificate has not used it as intended in the year following its issue. 

(cid:216) new 

6.  If a  national safety  authority  finds  that  a  holder  of  a single  safety  certificate  no  longer 
satisfies the conditions for certification, it shall ask the Agency to revoke it. The Agency may 
revoke  the  single  safety  certificate,  giving  reasons  for  its  decision.  The  Agency  shall 
immediately  inform  all  the  national  safety  authorities  of  the  networks  on  which  the  railway 
undertaking operates. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 
(cid:214) new 

76.  The  (cid:214) Agency   safety  authority  shall  inform  the  Agency  (cid:214) national  safety 
authorities  within one month of the issue, renewal, amendment or revocation of a (cid:214) single 
 safety certificate certificates referred to in paragraph 2(a) that have been issued, renewed, 
amended or revoked. It shall state the name and address of the railway undertaking, the issue 
date, the scope and validity of the safety certificate and, in the case of revocation, the reasons 
for its decision. 

7. Before 30 April 2009 the Agency shall evaluate the development of safety certification and 
submit a report to the Commission with recommendations on a strategy for migration towards 

EN 

35 

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a  single  Community  safety  certificate.  The  Commission  shall  take  appropriate  action 
following the recommendation.  

(cid:216) new 

8. The Agency shall continuously monitor the effectiveness of the measures for the issuing of 
single safety certificates and supervision by national safety authorities and, where appropriate, 
shall  make  recommendations  to  the  Commission  for  improvement.  These  may  include  a 
recommandation for a CSM covering a process of the safety management system which needs 
to be harmonised at Union level, as referred to in Article 6(1)(d). 

(cid:216) new 

Article 11 

Applications for single safety certificates 

1.  Applications  for  single  safety  certificates  shall  be  submitted  to  the  Agency.  The  Agency 
shall  take  a  decision  on  an  application  without  delay  and  in  any  event  not  more  than  four 
months  after  all  required  information  and  any  supplementary  information  requested  by  the 
Agency  has  been  submitted.  If  the  applicant  is  requested  to  submit  supplementary 
information, such information shall be submitted promptly. 

2. The Agency shall provide detailed guidance on how to obtain the single safety certificate. It 
shall list all requirements that have been laid down for the purpose of Article 10(2) and shall 
publish all relevant documents. 

3.  An  application  guidance  document  describing  and  explaining  the  requirements  for  the 
single  safety  certificates  and  listing  the  required  documents  shall  be  made  available  to 
applicants free of charge. The national safety authorities shall cooperate with the Agency in 
disseminating such information. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 
(cid:214) new 

Article 11 ⌦ 12 ⌫ 

Safety authorisation of infrastructure managers 

1.  In  order  to  be  allowed  to  manage  and  operate  a  rail  infrastructure,  the  infrastructure 
manager  must  ⌦ shall ⌫  obtain  a  safety  authorisation  from  the  ⌦ national ⌫  safety 
authority in the Member State where he ⌦ it ⌫ is established. 

The safety authorisation shall comprise: 

(a)  authorisation  confirming  acceptance  of  the  infrastructure  manager’s  safety  management 
system as described ⌦ laid down ⌫ in Article 9 and Annex III, which ⌦ shall include ⌫ 
includes  the  procedures  and  provisions  fulfilling  ⌦ for  meeting ⌫  the  requirements 
necessary  for  the  safe  design,  maintenance  and  operation  of  the  railway  infrastructure, 
including, where appropriate, ⌦ the ⌫ maintenance and operation of the traffic control and 
signalling system. 

EN 

36 

   EN 

 
 
 
 
and 

(b)  authorisation  confirming  acceptance  of  the  provisions  of  the  infrastructure  manager  to 
meet  specific  requirements  necessary  for  the  safe  design,  maintenance  and  operation  of  the 
railway  infrastructure  including,  where  appropriate,  the  maintenance  and  operation  of  the 
traffic control and signalling system. 

2. The safety authorisation shall be renewed upon application by the infrastructure manager at 
intervals  not  exceeding  (cid:214) of   five  years.  It  shall  be  wholly  or  partly  updated  whenever 
substantial  changes  are  made  to  the  infrastructure,  signalling  or  energy  supply  or  to  the 
principles  of  its  operation  and  maintenance.  The  holder  of  the  safety  authorisation  shall 
without delay inform the national safety authority of all such changes. 

The  national  safety  authority  may  require  that  the  safety  authorisation  be  revised  following 
substantial changes to the safety regulatory framework. 

If  the  national  safety  authority  finds  that  an  authorised  infrastructure  manager  no  longer 
satisfies  the  conditions  for  a  safety  authorisation  it  shall  revoke  the  authorisation,  giving 
reasons for its decisions. 

3. The national safety authority shall take a decision on an application for safety authorisation 
without delay and in any event not more than four months after all the information required 
and any supplementary information requested has been submitted. 

(cid:216) new 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 

34.  The  national  safety  authority  shall  inform  the  Agency  within  one  month  of  the  safety 
authorisations  that  have  been  issued,  renewed,  amended  or  revoked.  It  shall  state  the  name 
and address of the infrastructure manager, the issue date, the scope and validity of the safety 
authorisation and, in case of revocation, the reasons for its decision. 

Article 12 

Application requirements relating to safety certification and safety authorisation 

1. The safety authority shall take a decision on an application for safety certification or safety 
authorisation without delay and in any event not more than four months after all information 
required  and  any  supplementary  information  requested  by  the  safety  authority  has  been 
submitted.  If  the  applicant  is  requested  to  submit  supplementary  information,  such 
information shall be submitted promptly. 

2. In order to facilitate the establishment of new railway undertakings and the submission of 
applications from railway undertakings from other Member States, the safety authority shall 
give detailed guidance on how to obtain the safety certificate. It shall list all requirements that 
have  been  laid  down  for  the  purpose  of  Article  10(2)  and  make  all  relevant  documents 
available to the applicant. 

Special  guidance  shall  be  given  to  railway  undertakings  that  apply  for  a  safety  certificate 
concerning services on a defined limited part of an infrastructure, specifically identifying the 
rules that are valid for the part in question. 

EN 

37 

   EN 

 
 
 
3.  An  application  guidance  document  describing  and  explaining  the  requirements  for  the 
safety certificates and listing the documents that must be submitted shall be made available to 
the applicants free of charge. All applications for safety certificates shall be submitted in the 
language required by the safety authority. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 

Article 13 

Access to training facilities 

1. Member States shall ensure that railway undertakings applying for a safety certificate have 
fair  and  non-discriminatory  access  to  training  facilities  for  train  drivers  and  staff 
accompanying the trains, whenever such training is necessary for operating services on their 
network or, for fulfilling the fulfilment of requirements to obtain the safety certificate ⌦ and 
requirements to obtain licences and certificates under Directive 2007/59/EC21 ⌫ . 

The  services  offered  must  shall  include  training  on  necessary  route  knowledge,  operating 
rules and procedures, the signalling and control command system and emergency procedures 
applied on the routes operated. 

Member States shall also ensure that infrastructure managers and their staff performing vital 
safety tasks have fair and non-discriminatory access to training facilities. 

If  the  training  services  do  not  include  examinations  and  granting  of  certificates,  Member 
States  shall  ensure  that  railway  undertakings  have  access  to  such  certificationif  it  is  a 
requirement of the safety certificate. 

The  national  safety  authority  shall  ensure  that  the  provision  of  training  services  or,  where 
appropriate,  the  granting  of  certificates  meets  the  safety  requirements  laid  down  in 
⌦ Directive 2007/59/EC, in ⌫ TSIs or national safety rules described ⌦ referred to ⌫ in 
Article 8 and Annex II. 

2.  If  the  training  facilities  are  available  only  through  the  services  of  one  single  railway 
undertaking  or  the  infrastructure  manager,  Member  States  shall  ensure  that  they  are  made 
available to other railway undertakings at a reasonable and non-discriminatory price, which is 
cost-related and may include a profit margin. 

3.  When  recruiting  new  train  drivers,  staff  on  board  trains  and  staff  performing  vital  safety 
tasks, railway undertakings must shall be able to take into account any training, qualifications 
and experience  acquired previously from other  railway  undertakings. For this purpose, such 
members  of  staff  shall  be  entitled  to  have  access  to,  obtain  copies  and  communicate  all 
documents attesting to their training, qualifications and experience. 

4.  In  every  case  each  railway  undertaking  and  each  infrastructure  manager  ⌦ Railway 
undertakings and infrastructure managers ⌫ shall be responsible for the level of training and 
qualifications of its staff carrying out safety-related work as set out in Article 9 and Annex III. 

(cid:208) 2008/57/EC Art. 40 

--- 

21 

OJ L 315, 3.12.2007, p. 51. 

EN 

38 

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(cid:208) 2008/110/EC Art. 1.8 (adapted) 
(cid:214) new 

Article 14a 

Maintenance of vehicles 

1. Each vehicle, before it is placed in service or used on the network, shall have an entity in 
charge of maintenance assigned to it and this entity shall be registered in the national vehicle 
register NVR in accordance with Article 4333 of the Railway Interoperability Directive XX 
on interoperability of the rail system. 

2. A railway undertaking, an infrastructure manager or a keeper may be an entity in charge of 
maintenance. 

3.  Without  prejudice  to  the  responsibility  of  the  railway  undertakings  and  infrastructure 
managers for the safe operation of a train as provided for in Article 4, the entity shall ensure 
that  the  vehicles  for  which  it  is  in  charge  of  maintenance  are  in  a  safe  state  of  running  by 
means  of  a  system  of  maintenance.  To  this  end,  the  entity  in  charge  of  maintenance  shall 
ensure that vehicles are maintained in accordance with: 

(a) 

the maintenance file of each vehicle; 

(b) 

the requirements in force including maintenance rules and TSI provisions. 

The  entity  in  charge  of  maintenance  shall  carry  out  the  maintenance  itself  or  make  use  of 
contracted maintenance workshops. 

4. In the case of freight wagons, each entity in charge of maintenance shall be certified by a 
body  accredited  or  recognised  in  accordance  with  (cid:214) Commission  Regulation  (EU)  No 
445/201122  paragraph 5, or by a national safety authority. The accreditation process shall 
be  based  on  criteria  of  independence,  competence  and  impartiality,  such  as  the  relevant  EN 
45-000 series European standards. The recognition process shall also be based on criteria of 
independence, competence and impartiality. 

Where  the  entity  in  charge  of  maintenance  is  a  railway  undertaking  or  an  infrastructure 
manager,  compliance  with  (cid:214) Regulation  (EU)  No  445/2011   the  requirements  to  be 
adopted under paragraph 5 shall be checked by the relevant national safety authority pursuant 
to the procedures referred to in Articles ⌦ Article 12 ⌫ 10 or 11 and shall be confirmed on 
the certificates specified in those procedures. 

5. Based on a recommendation by the Agency, the Commission shall, by 24 December 2010, 
adopt a measure establishing a system of certification of the entity in charge of maintenance 
for  freight  wagons.  Certificates  granted  in  accordance  with  this  system  shall  confirm 
compliance with the requirements referred to in paragraph 3. 

The measure shall include the requirements concerning: 

(a) 

the maintenance system established by the entity; 

(b) 

the format and validity of the certificate granted to the entity; 

22 

OJ L 122, 11.5.2011, p. 22. 

EN 

39 

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(c) 

the  criteria  for  accreditation  or  recognition  of  body  or  bodies  responsible  for 
issuing  certificates  and  ensuring  controls  necessary  for  the  functioning  of  the 
certification system; 

(d) 

the date of application of the certification system, including a transition period 
of one year for existing entities in charge of maintenance. 

This measure, designed to amend non-essential elements of this Directive, by supplementing 
it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in 
Article 27(2a). 

Based  on  a  recommendation  by  the  Agency,  the  Commission  shall,  by  24  December  2018 
review  this  measure  in  order  to  include  all  vehicles  and  to  update,  if  necessary,  the 
certification system applicable to freight wagons. 

56.  The  certificates  granted  in  accordance  with  paragraph  45  shall  be  valid  throughout  the 
⌦ Union ⌫ Community. 

7.  The  Agency  shall  evaluate  the  certification  process  implemented  in  accordance  with 
paragraph 5 by submitting a report to the Commission, no later than three years after the entry 
into force of the relevant measure. 

(cid:216) new 

6.  By  31  May  2014,  the  Agency  shall  evaluate  the  system  of  certification  of  the  entity  in 
charge of maintenance for freight wagons and shall consider the opportunity for an extension 
of that system to all vehicles and shall submit a report to the Commission. 

7.  The  Commission  shall,  by  means  of  implementing  acts,  adopt  common  conditions  for 
certification of the entity in charge of maintenance for all vehicles by 24 December 2016. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 27 (2). 

The  certification  system  applicable  to  freight  wagons  adopted  by  Regulation  (EU)  No 
445/2011  shall  continue  to  apply  until  the  implementing  acts  referred  to  in  the  first 
subparagraph are adopted. 

(cid:208) 2008/110/EC Art. 1.8 (adapted) 
(cid:214) new 

⌦ Article 15 ⌫ 

⌦ Derogations from the system of certification of the entities in charge of 
maintenance ⌫ 

18.  Member  States  may  decide  to  fulfil  the  obligations  to  identify  the  entity  in  charge  of 
maintenance  and  to  certify  it  through  alternative  measures  (cid:214) respect  to  the  system  of 
certification established in article 14  , in the following cases: 

(a) 

vehicles  registered  in  a  third  country  and  maintained  according  to  the  law  of 
that country; 

(b)  vehicles  which  are  used  on  networks  or  lines  the  track  gauge  of  which  is 
different  from  that  of  the  main  rail  network  within  the  Community 
⌦ Union ⌫  and  for  which  fulfilment  of  the  requirements  referred  to  in 

EN 

40 

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Article  14(3)  paragraph  3  is  ensured  by  international  agreements  with  third 
countries; 

(c) 

vehicles  identified  in ⌦ covered  by ⌫  Article  2(2),  and  military  equipment 
and special transport requiring an ad hoc national safety authority permit to be 
delivered  prior  to  the  service.  In  this  case  derogations  shall  be  granted  for 
periods not longer than five years. 

2. Such alternative measures ⌦ Alternative measures referred to in paragraph 1 ⌫ shall be 
implemented through derogations to be granted by the relevant national safety authority ⌦ or 
the Agency ⌫ : 

(a)  when  registering  vehicles  pursuant  to  Article  4333  of  Directive  xx  on 
interoperability of the rail system the Railway Interoperability Directive, as far 
as the identification of the entity in charge of maintenance is concerned; 

(b)  when  delivering  safety  certificates  and  authorisations  to  railway  undertakings 
and infrastructure managers pursuant to Articles 10 and 1211 of this Directive, 
as  far  as  the  identification  or  certification  of  the  entity  in  charge  of 
maintenance is concerned. 

3. Such derogations shall be identified and justified in the annual safety report referred to in 
Article 18 of this Directive. Where it appears that undue safety risks are being taken on the 
Community ⌦ Union ⌫ rail system, the Agency shall immediately inform the Commission 
thereof. The Commission shall make contact with the parties involved and, where appropriate, 
request the Member State to withdraw its derogation decision. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 

Article 15 

Harmonisation of safety certificates 

1. Before 30 April 2009 decisions on common harmonised requirements in accordance with 
Article 10(2)(b)  and  Annex IV  and  a  common  format  for  application  guidance  documents 
shall be adopted in accordance with the procedure referred to in Article 27(2). 

2. The Agency shall recommend common harmonised requirements and a common format for 
application guidance documents under a mandate which shall be adopted in accordance with 
the procedure referred to in Article 27(2). 

CHAPTER IV 

⌦ NATIONAL ⌫ SAFETY AUTHORITIES 

Article 16 

Tasks 

1. Each Member State shall establish a safety authority. This authority may be the Ministry 
responsible for transport matters and shall be independent in its organisation, legal structure 
and  decision  making  from  any  railway  undertaking,  infrastructure  manager,  applicant  and 
procurement entity. 

EN 

41 

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2. The national safety authority shall be entrusted with at least the following tasks: 

(cid:216) new 

(a) 

(b) 

authorising the placing in service of the energy and infrastructure subsystems 
constituting the rail system in accordance with Article 18(2) of Directive XX 
on interoperability of the rail system; 

supervising  that  the  interoperability  constituents  are  in  compliance  with  the 
essential  requirements  as  required  by  Article  [x]  of  Directive  [XX]  on 
interoperability of the rail system; 

(c) 

assigning  a  European  vehicle  numbering  in  accordance  with  Article  42  of 
Directive [XX] on interoperability of the rail system; 

(d)  on request of the Agency, supporting it in the issue, renewal, amendment and 
revocation  of  single  safety  certificates  granted  in  accordance  with  Article  10 
and checking that the conditions and requirements laid down in them are met 
and 
the 
requirements of Union or national law;  

that  railway  undertakings  are  operating 

in  accordance  with 

(e) 

issuing,  renewing,  amending  and  revoking  safety  authorisations  granted  in 
accordance with Article 12 and checking that the conditions and requirements 
laid  down  in  them  are  met  and  that  infrastructure  managers  are  operating  in 
accordance with the requirements of Union or national law; 

(f)  monitoring,  promoting,  and,  where  appropriate,  enforcing  and  updating  the 

safety regulatory framework including the system of national rules; 

(g) 

(h) 

supervising  the  railway  undertakings  in  accordance  with  Annex  IV  to 
Regulation (EU) No 1158/201023 and with Regulation (EU) No 1077/201224; 

supervising that vehicles are duly registered in the national vehicle register and 
that safety-related information contained in it is accurate and up to date. 

3. The national safety authority of the Member State where the railway undertaking operates 
shall make necessary arrangements to coordinate with the Agency and other safety authorities 
to ensure that any key information on the specific railway undertaking is shared, particularly 
on  known  risks  and  its  safety  performance.  The  national  safety  authority  shall  also  share 
information  with  other  relevant  national  safety  authorities  if  it  finds  that  the  railway 
undertaking is not taking the necessary risk control measures. 

It shall inform the Agency immediately of any concerns about the safety performance of the 
railway  undertakings  under  supervision.  The  Agency  shall  take  appropriate  action  provided 
for in Article 10(6). 

2. The safety authority shall be entrusted with at least the following tasks: 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 

23 
24 

OJ L 326, 10.12.2010, p.11. 
OJ L 320, 17.11.2012, p. 3 

EN 

42 

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(a) authorising the placing in service of the structural subsystems constituting the rail 
system in accordance with Article 15 of the Railway Interoperability Directive and checking 
that they are operated and maintained in accordance with the relevant essential requirements; 

(cid:208) 2008/110/EC Art. 1.9(a) 

--- 

(cid:208) 2008/110/EC Art. 1.9(b) 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16  

(c)  supervising  that  the  interoperability  constituents  are  in  compliance  with  the 

essential requirements as required by Article 12 of Directives 96/48/EC and 2001/16/EC; 

(d) authorising the placing in service of new and substantially altered rolling stock that 

is not yet covered by a TSI; 

(e)  the  issue,  renewal,  amendments  and  revocation  of  relevant  parts  of  safety 
certificates  and  of  safety  authorisations  granted  in  accordance  with  Articles 10  and 11  and 
checking that conditions and requirements laid down in them are met and that infrastructure 
managers  and  railway  undertakings  are  operating  under  the  requirements  of  Community  or 
national law; 

(f)  monitoring,  promoting,  and,  where  appropriate,  enforcing  and  developing  the 

safety regulatory framework including the system of national safety rules; 

(g)  supervising  that  vehicles  are  duly  registered  in  the  NVR  and  that  safety  related 

information contained therein, is accurate and kept up to date; 

(cid:208) 2008/110/EC Art. 1.9(c) 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 
(cid:214) new 

4.  The  tasks  referred  to  in  paragraph 2 may  not  be  transferred  or  subcontracted  to  any 
infrastructure manager, railway undertaking or procurement entity. 

Article 17 

Decision-making principles 

1. The ⌦ national ⌫ safety authority ⌦ authorities ⌫ shall carry out its ⌦ their ⌫ tasks 
in an open, non-discriminatory and transparent way. In particular it ⌦ they ⌫ shall allow all 
parties to be heard and give reasons for its ⌦ their ⌫ decisions. 

It  ⌦ They ⌫  shall  promptly  respond  to  requests  and  applications  and  communicate  its 
⌦ their ⌫  requests  for  information  without  delay  and  adopt  all  its  ⌦ their ⌫  decisions 
within four months after all requested information has been provided. It ⌦ They ⌫ may at 
any time request the technical assistance of infrastructure managers and railway undertakings 

EN 

43 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
or other qualified bodies when it is ⌦ they are ⌫ carrying out the tasks referred to in Article 
16. 

In  the  process  of  developing  the  national  regulatory  framework,  the  ⌦ national ⌫  safety 
authority  shall  consult  all  persons  involved  and  interested  parties,  including  infrastructure 
managers,  railway  undertakings,  manufacturers  and  maintenance  providers,  users  and  staff 
representatives. 

2.  ⌦ The  Agency  and  the  national ⌫  safety  authority  ⌦ authorities ⌫  shall  be  free  to 
carry  out  all  inspections  and  investigations  that  are  needed  for  accomplishment  of  its 
⌦ their ⌫ tasks and it ⌦ they ⌫ shall be granted access to all relevant documents and to 
premises, installations and equipment of infrastructure managers and railway undertakings. 

3.  Member  States  shall  take  the  measures  necessary  to  ensure  that  decisions  taken  by  the 
⌦ national ⌫ safety authority are subject to judicial review. 

4.  The  ⌦ national ⌫  safety  authorities  shall  conduct  an  active  exchange  of  views  and 
experience  (cid:214) within  the  network  established  by  the  Agency in  order  to  harmonise  their 
decision-making  criteria  across  the  Union.  for  the  purpose  of  harmonising  their  decision-
making criteria across the Community. Their cooperation shall in particular aim at facilitating 
and  coordinating  the  safety  certification  of  railway  undertakings  which  have  been  granted 
international train paths in accordance with the procedure laid down in Article 15 of Directive 
2001/14/EC. 

The Agency shall support the safety authorities in these tasks. 

(cid:216) new 

5.  The  scope  of  cooperation  between  the  Agency  and  the  national  safety  authorities  in  all 
matters  relating  to  inspections  on  site  related  to  issuing  the  single  safety  certificate  and 
supervision of the railway undertakings after issuing the single safety certificate shall be set 
out  in  contractual  or  other  arrangements  between  the  Agency  and  the  national  safety 
authorities. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 

Article 18 

Annual report 

Each year the national safety authority shall publish an annual report concerning its activities 
in the preceding year and send it to the Agency by 30 September at the latest. The report shall 
contain information on: 

(a) 

the development of railway safety, including an aggregation at Member State 
level of the CSIs laid down in Annex I; 

(b) 

important changes in legislation and regulation concerning railway safety; 

(c) 

(d) 

the development of safety certification and safety authorisation; 

results of and experience relating to the supervision of infrastructure managers 
and railway undertakings; 

EN 

44 

   EN 

 
 
 
(cid:208) 2008/110/EC Art. 1.10 
(adapted) 
(cid:214) new 

(e) 

the  derogations  that  have  been  decided  in  accordance  with  Article  14a 
⌦ 14 ⌫ (8).; 

(cid:214) (f) all inspections or audits of railway undertakings operating in the Member State 

in the course of supervision activities.  

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 

CHAPTER V 

ACCIDENT AND INCIDENT INVESTIGATION 

Article 19 

Obligation to investigate 

1.  Member  States  shall  ensure  that  an  investigation  is  carried  out  by  the  investigating  body 
referred to in Article 21 after serious accidents on the railway system, the objective of which 
is possible improvement of railway safety and the prevention of accidents. 

2.  In  addition  to  serious  accidents,  the  investigating  body  referred  to  in  Article  21 may 
investigate those accidents and incidents which under slightly different conditions might have 
led  to  serious  accidents,  including  technical  failures  of  the  structural  subsystems  or  of 
interoperability constituents of the European rail system. 

The investigating body shall, at its discretion, decide whether or not an investigation of such 
an accident or incident shall be undertaken. In its decision it shall take into account: 

(a) 

the seriousness of the accident or incident; 

(b)  whether it forms part of a series of accidents or incidents relevant to the system 

as a whole; 

(c) 

its impact on railway safety on a Community Union level, 

and 

(d) 

requests  from  infrastructure  managers,  railway  undertakings,  the  national 
safety authority or the Member States. 

3.  The  extent  of  investigations  and  the  procedure  to  be  followed  in  carrying  out  such 
investigations  shall  be  determined  by  the  investigating  body,  taking  into  account  the 
principles and the objectives of Articles 20 and 22 and depending on the lessons it expects to 
draw from the accident or incident for the improvement of safety. 

4. The investigation shall in no case be concerned with apportioning blame or liability. 

Article 20 

Status of investigation 

EN 

45 

   EN 

 
 
 
1.  Member  States  shall  define,  in  the  framework  of  their  respective  legal  system,  the  legal 
status of the  investigation that  will shall enable the  investigators-in-charge to carry out their 
task in the most efficient way and within the shortest time. 

2. In accordance with the legislation in force in the Member States and, where appropriate, in 
cooperation with the authorities responsible for the judicial inquiry, the investigators shall, as 
soon as possible, be given: 

2. In accordance with the legislation in force, Member States shall ensure full cooperation by 
the authorities responsible for the judicial inquiry, and shall ensure that the investigators are, 
as soon as possible, given: 

(cid:216) new 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 

(a) 

(b) 

(c) 

access  to  the  site  of  the  accident  or  incident  as  well  as  to  the  rolling  stock 
involved, 
traffic  control  and  signalling 
installations; 

infrastructure  and 

the  related 

the  right  to  an  immediate  listing  of  evidence  and  controlled  removal  of 
wreckage,  infrastructure  installations  or  components  for  examination  or 
analysis purposes; 

access  to  and  use  of  the  contents  of  on-board  recorders  and  equipment  for 
recording of verbal messages and registration of the operation of the signalling 
and traffic control system; 

(d) 

access to the results of examination of the bodies of victims; 

(e) 

(f) 

(g) 

access  to  the  results  of  examinations  of  the  train  staff  and  other  railway  staff 
involved in the accident or incident; 

the opportunity to question the railway staff involved and other witnesses; 

access  to  any  relevant  information  or  records  held  by  the  infrastructure 
manager,  the  railway  undertakings  involved  and  the  ⌦ national ⌫  safety 
authority. 

3. The investigation shall be accomplished independently of any judicial inquiry. 

Article 21 

Investigating body 

1. Each Member State shall ensure that investigations of accidents and incidents referred to in 
Article 19 are conducted by a permanent body, which shall comprise at least one investigator 
able to perform the function of investigator-in-charge in the event of an accident or incident. 
This body shall be independent in its organisation, legal structure and decision-making from 
any infrastructure manager, railway undertaking, charging body, allocation body and notified 
body,  and  from  any  party  whose  interests  could  conflict  with  the  tasks  entrusted  to  the 
investigating body. It shall furthermore be functionally independent from the ⌦ national ⌫ 
safety authority and from any regulator of railways. 

EN 

46 

   EN 

 
 
 
2. The investigating body shall perform its tasks independently of the organisations referred to 
in paragraph 1 and shall be able to obtain sufficient resources to do so. Its investigators shall 
be afforded status giving them the necessary guarantees of independence. 

3.  Member  States  shall  make  provision  that  railway  undertakings,  infrastructure  managers 
and, where appropriate, the ⌦ national ⌫ safety authority, are obliged immediately to report 
accidents and incidents referred to in Article 19 to the investigating body. The investigating 
body shall be able to respond to such reports and make the necessary arrangements to start the 
investigation  no  later  than  one  week  after  receipt  of  the  report  concerning  the  accident  or 
incident. 

4.  The  investigating  body  may  combine  its  tasks  under  this  Directive  with  the  work  of 
investigating  occurrences  other  than  railway  accidents  and  incidents  as  long  as  such 
investigations do not endanger its independence. 

5. If necessary the investigating body may request the assistance of investigating bodies from 
other  Member  States  or  from  the  Agency  to  supply  expertise  or  to  carry  out  technical 
inspections, analyses or evaluations. 

6.  Member  States  may  entrust  the  investigating  body  with  the  task  of  carrying  out 
investigations of railway accidents and incidents other than those referred to in Article 19. 

7.  The  investigating  bodies  shall  conduct  an  active  exchange  of  views  and  experience  for 
the purpose of developing common investigation methods, drawing up common principles for 
follow-up  of  safety  recommendations  and  adaptation  to  the  development  of  technical  and 
scientific progress. 

The Agency shall support the investigating bodies in this task. 

Article 22 

Investigation procedure 

1. An accident or incident referred to in Article 19 shall be investigated by the investigation 
body  of  the  Member  State  in  which  it  occurred.  If  it  is  not  possible  to  establish  in  which 
Member  State  it  occurred  or  if  it  occurred  on  or  close  to  a  border  installation  between  two 
Member  States  the  relevant  bodies  shall  agree  which  one  of  them  will  shall  carry  out  the 
investigation or shall agree to carry it out in cooperation. The other body shall in the first case 
be allowed to participate in the investigation and fully share its results. 

Investigation  bodies  from  another  Member  State  shall  be  invited  to  participate  in  an 
investigation whenever a railway undertaking established and licensed in that Member State is 
involved in the accident or incident. 

This  paragraph  shall  not  preclude  Member  States  from  agreeing  that  the  relevant  bodies 
should shall carry out investigations in cooperation in other circumstances. 

2. For each accident or incident the body responsible for the investigation shall arrange for the 
appropriate means, comprising the necessary operational and technical expertise to carry out 
the investigation. The expertise may be obtained from inside or outside the body, depending 
on the character of the accident or incident to be investigated. 

3. The investigation shall be carried out with as much openness as possible, so that all parties 
can  be  heard  and  can  share  the  results.  The  relevant  infrastructure  manager  and  railway 
undertakings,  the  ⌦ national ⌫  safety  authority,  victims  and  their  relatives,  owners  of 
damaged  property,  manufacturers,  the  emergency  services  involved  and  representatives  of 
staff and users shall be regularly informed of the investigation and its progress and, as far as 

EN 

47 

   EN 

 
practicable,  shall  be  given  an  opportunity  to  submit  their  opinions  and  views  to  the 
investigation and be allowed to comment on the information in draft reports. 

4. The investigating body shall conclude its examinations at the accident site in the shortest 
possible  time  in  order  to  enable  the  infrastructure  manager  to  restore  the  infrastructure  and 
open it to rail transport services as soon as possible. 

Article 23 

Reports 

1. An investigation of an accident or incident referred to in Article 19 shall be the subject of 
reports in a form appropriate to the type and seriousness of the accident or incident and the 
relevance  of  the  investigation  findings.  The  reports  shall  state  the  objectives  of  the 
investigations  as  referred  to  in  Article  19(1)  and  contain,  where  appropriate,  safety 
recommendations. 

2. The investigating body shall make public the final report in the shortest possible time and 
normally not later than 12 months after the date of the occurrence. The report shall, as close as 
possible, follow the reporting structure laid down in Annex V. The report, including the safety 
recommendations,  shall  be  communicated  to  the  relevant  parties  referred  to  in  Article 22(3) 
and to bodies and parties concerned in other Member States. 

The Commission shall establish, by means of implementing acts, the content of accident and 
incident investigation reports. Those implementing acts shall be adopted in accordance with 
the examination procedure referred to in Article 27(2). 

(cid:216) new 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 

3.  Each  year  the  investigating  body  shall  publish  by  30 September  at  the  latest  an  annual 
report  accounting  for  the  investigations  carried  out  in  the  preceding  year,  the  safety 
recommendations  that  were  issued  and  actions  taken  in  accordance  with  recommendations 
issued previously. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 

Article 24 

Information to be sent to the Agency 

1.  Within  one  week  after  the  decision  to  open  an  investigation  the  investigating  body  shall 
inform  the  Agency  thereof.  The  information  shall  indicate  the  date,  time  and  place  of  the 
occurrence, as well as its type and its consequences as regards fatalities, injuries and material 
damage. 

2.  The  investigating  body  shall  send  the  Agency  a  copy  of  the  final  report  referred  to  in 
Article 23(2) and of the annual report referred to in Article 23(3). 

EN 

48 

   EN 

 
 
 
 
Article 25 

Safety recommendations 

1.  A  safety  recommendation  issued  by  an  investigating  body  shall  in  no  case  create  a 
presumption of blame or liability for an accident or incident. 

2. Recommendations shall be addressed to the ⌦ Agency, to the national ⌫ safety authority 
and,  where  needed  by  reason  of  the  character  of  the  recommendation,  to  other  bodies  or 
authorities  in  the  Member  State  or  to  other  Member  States.  Member  States  and  their 
⌦ national ⌫ safety authorities shall take the necessary measures to ensure that the safety 
recommendations  issued  by  the  investigating  bodies  are  duly  taken  into  consideration,  and, 
where appropriate, acted upon. 

3. The ⌦ national ⌫ safety authority and other authorities or bodies or, when appropriate, 
other  Member  States  to  which  recommendations  have  been  addressed,  shall  report  back  at 
least  annually  to  the  investigating  body  on  measures  that  are  taken  or  planned  as  a 
consequence of the recommendation. 

CHAPTER VI 

FINAL PROVISIONS 

(cid:208) 2008/110/EC Art. 1.11 
(adapted) 

Article 26 

Adaptation of the Annexes 

The Annexes shall be adapted to scientific and technical progress. This measure, designed to 
amend  non-essential  elements  of  this  Directive,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 27(2a). 

(cid:216) new 

Article 26 

Exercise of delegation 

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions 
laid down in this Article. 

2. The power to adopt delegated acts referred to in Articles 5(2) and 7(2) shall be conferred on 
the Commission for an indeterminate period of time.  

3. The delegation of power referred to in Article 5(2) and 7(2) may be revoked at any time by 
the  European  Parliament  or  by  the  Council.  A  decision  to  revoke  shall  put  an  end  to  the 
delegation  of  the  power  specified  in  that  decision.  It  shall  take  effect  the  day  following  the 
publication  of  the  decision  in  the  Official  Journal  of  the  European  Union  or  at  a  later  date 
specified therein. It shall not affect the validity of any delegated acts already in force. 

4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the 
European Parliament and to the Council. 

EN 

49 

   EN 

 
 
 
5. A delegated act adopted pursuant to Articles 5(2) and 7(2) shall enter into force only if no 
objection  has  been  expressed  by  either  the  European  Parliament  or  the  Council  within  a 
period of two months of notification of that act to the European Parliament and the Council, 
or  if,  before  expiry  of  that  period,  the  European  Parliament  and  the  Council  have  both 
informed  the  Commission  that  they  will  not  object.  The  period  shall  be  extended  by  two 
months at the initiative of the European Parliament or the Council. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 
(cid:214) new 

Article 27 

Committee procedure 

1.  The  Commission  shall  be  assisted  by  the  Committee  set  up  by  Article  21  of 
Directive 96/48/EC. 

(cid:214) 1. The Commission shall be assisted by a committee. That committee shall be a committee 
within the meaning of Regulation (EU) No 182/2011.  

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall 
apply, having regard to the provisions of Article 8 thereof. 

(cid:214) 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 
shall apply.  

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 

2a. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

(cid:208) 2008/110/EC Art. 1.12(a) 
(adapted) 

3. Where reference is made to this paragraph, Article 3 and 7 of Decision 1999/468/EC shall 
apply, having regard to the provisions of Article 8 thereof. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 

--- 

(cid:208) 2008/110/EC Art. 1.12(b) 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 

Article 28 

Implementing measures 

EN 

50 

   EN 

 
 
 
 
 
 
1. Member States may bring any measures concerning the implementation of this Directive to 
the attention of the Commission. Appropriate decisions shall be adopted in accordance with 
the procedure referred to in Article 27(2). 

2.  At  the  request  of  a  Member  State  or  on  its  own  initiative  the  Commission  shall,  in  a 
specific  case,  examine  the  application  and  enforcement  of  provisions  concerning  safety 
certification  and  safety  authorisation,  and  within  two  months  of  receipt  of  such  a  request 
decide  in  accordance  with  the  procedure  referred  to  in  Article 27(2)  whether  the  related 
measure may continue to be applied. The Commission shall communicate its decision to the 
European Parliament, the Council and the Member States. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 

CHAPTER VII 

GENERAL AND FINAL PROVISIONS 

Article 29 

Amendments to Directive 95/18/EC 

Directive 95/18/EC is hereby amended as follows: 

1. Article 8 shall be replaced by the following: 

‘Article 8 

The requirements relating to professional competence shall be met when an applicant 
railway undertaking has or will have a management organisation which possesses the 
knowledge  and/or  experience  necessary  to  exercise  safe  and  reliable  operational 
control and supervision of the type of operations specified in the licence.’» 

2. in the Annex, Section II shall be deleted. 

Article 30 

Amendments to Directive 2001/14/EC 

Directive 2001/14/EC is hereby amended as follows: 

1. the title shall be replaced by the following: 

‘Directive 2001/14/EC of the European Parliament and of the Council of 26 February 
2001 on the allocation of railway infrastructure capacity and the levying of charges 
for the use of railway infrastructure’» 

2. in Article 30(2), point (f) shall be replaced by the following: 

‘(f) arrangements for access in accordance with Article 10 of Council Directive 
91/440/EEC  of  29 July  1991  on  the  development  of  the  Community's 
railways25  as  amended  by  Directive  2004/51/EC  of  the  European  Parliament 

25 

OJ L 237, 24.8.1991, p. 25. 

EN 

51 

   EN 

 
 
 
 
 
 
 
 
 
                                                 
and of the Council of 30 April 2004 amending Council Directive 91/440/EEC 
on the development of the Community's railways26.’» 

3. Article 32 shall be deleted, 

4. in Article 34, paragraph 2 shall be replaced by the following: 

‘2. At the request of a Member State or on its own initiative the Commission shall, in 
a  specific  case,  examine  the  application  and  enforcement  of  provisions  concerning 
charging,  capacity  allocation,  and  within  two  months  of  receipt  of  such  a  request 
decide  in  accordance  with  the  procedure  referred  to  in  Article  35(2)  whether  the 
related measure may continue to be applied. The Commission shall communicate its 
decision to the European Parliament, the Council and to the Member States.’» 

Article 31 ⌦ 28 ⌫ 

Report and further Community ⌦ Union ⌫ action 

The Commission shall submit to the European Parliament and to the Council before 30 April 
2007 and every five years thereafter a report on the implementation of this Directive. 

On the basis of relevant information provided by the Agency, the Commission shall submit to 
the European Parliament and to the Council before [specific date to be inserted by OPOCE - 
five  years  after  the  date  of  entry  into  force] and  every  five  years  thereafter  a  report  on  the 
implementation of this Directive. 

(cid:216) new 

The  report  shall  be  accompanied  where  necessary  by  proposals  for  further  Community 
⌦ Union ⌫ action. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 

Article 32⌦ 29 ⌫  

Penalties 

The Member States shall lay down the rules on penalties applicable to infringements of the 
national provisions adopted pursuant to this Directive and shall take all measures necessary to 
ensure that they are implemented. The penalties provided for must be effective, proportionate, 
non-discriminatory and dissuasive. 

The  Member  States  shall  notify  those  rules  to  the  Commission  by  the  date  specified  in 
Article 33  ⌦ 32(1) ⌫  and  shall  notify  it  without  delay  of  any  subsequent  amendment 
affecting them. 

26 

OJ L 164, 30.4.2004, p. 164. 

EN 

52 

   EN 

 
 
 
 
 
 
                                                 
(cid:216) new 

Article 30 

Transitional provisions 

Annexes  III  and  V  to  Directive  2004/49/EC  shall  apply  until  the  date  of  application  of  the 
implementing acts referred to in Articles 6(2) and (3), 9(2), 14(7) and 23(2) of this Directive. 

Until [specific date to be inserted by OPOCE - two years after the date of entry into force], 
the national safety authorities shall continue to grant safety certificates in accordance with the 
provisions of Directive 2004/49/EC. Such safety certificates shall be valid until their date of 
expiry. 

Article 31 

Recommendations and opinions and of the Agency 

The  Agency  shall  provide  recommendations  and  opinions  in  accordance  with  Article  15  of 
Regulation …/… [Agency Regulation] for the purpose of application of this Directive. These 
recommendations  and  opinions  will  serve  as  basis  for  any  Union  measure  adopted  pursuant 
this Directive. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 
(cid:214) new 

Article 33 ⌦ 32 ⌫ 

Implementation ⌦ Transposition ⌫ 

1.  Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative  provisions 
necessary to comply with this Directive ⌦ Articles 2, 3, 4, 8, 10, 16, 18, 20 and Annex I ⌫ 
by (cid:214) [specific date to be inserted by OPOCE - two years after the date of entry into force]  
30 April 2006 at the latest. They shall forthwith inform the Commission thereof. (cid:214) They shall 
forthwith communicate to the Commission the text of those provisions.  

2. When Member States adopt those measures, they shall contain a reference to this Directive 
or  shall  be  accompanied  by  such  reference  on  the  occasion  of  their  official  publication. 
(cid:214) They  shall  also  include  a  statement  that  references  in  existing  laws,  regulations  and 
administrative  provisions  to  the  directives  repealed  by  this  Directive  shall  be  construed  as 
references to this Directive. Member States shall determine how such reference is to be made 
and how that statement is to be formulated.  The methods of making such reference shall be 
laid down by Member States.  

Member  States  shall  communicate  to  the  Commission  the  text  of  the  main  provisions  of 
national law which they adopt in the field covered by this Directive. 

(cid:216) new 

EN 

53 

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3. The obligation to transpose and implement this Directive shall not apply to the Republic of 
Cyprus  and  the  Republic  of  Malta  for  as  long  as  no  rail  system  is  established  within  their 
territory. 

However,  as  soon  as  a  public  or  private  entity  submits  an  official  application  to  build  a 
railway line with a  view  to  its  operation by one  or  more  railway  undertakings,  the  Member 
States  concerned  shall  put  in  place  legislation  to  implement  this  Directive  within  one  year 
from receipt of the application. 

Article 33 

Repeal 

Directive  2004/49/EC,  as  amended  by  the  Directives  listed  in  Annex  II,  Part  A,  is  repealed 
with  effect  from  [specific  date  to  be  inserted  by  OPOCE  –two  years  after  the  date  of  entry 
into  force],  without  prejudice  to  the  obligations  of  the  Member  States  concerning  the  time 
limits for transposition into national law and application of the Directives set out in Annex II, 
Part B. 

References  to  the  repealed  Directive  shall  be  construed  as  references  to  this  Directive  and 
shall be read in accordance with the correlation table in Annex III. 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 

Article34 

Entry into force 

This Directive shall enter into force on the ⌦ twentieth ⌫ day ⌦ following that ⌫ of its 
publication in the Official Journal of the European Union. 

Articles 10 and 11 shall apply from [specific date to be inserted by OPOCE - two years after 
the date of entry into force]. 

(cid:216) new 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 (adapted) 

Article35 

Addressees 

This Directive is addressed to the Member States. 

Done at Brussels,  

⌦ For the European Parliament 
⌦ The President 

For the Council ⌫ 
The President ⌫ 

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(cid:208) 2009/149/EC Art. 1 and Annex 
(adapted) 

ANNEX I 

COMMON SAFETY INDICATORS 

Common  safety  indicators  shall  ⌦ are  to ⌫  be  reported  annually  by  the  ⌦ national ⌫ 
safety authorities. The first reporting period shall be 2010. 

Indicators relating to activities referred to in Article 2(2), (a) and (b), should be accounted for 
separately, if they are submitted. 

If new facts or errors are discovered after the submission of the report the indicators for one 
particular  year  shall  ⌦ are  to ⌫  be  amended  or  corrected  by  the  ⌦ national ⌫  safety 
authority at the first convenient opportunity and at the latest in the next annual report. 

For  indicators  relating  to  accidents  under  heading  ⌦ point ⌫  1,  Regulation  (EC) 
No 91/2003  of  the  European  Parliament  and  of  the  Council  of  16  December  2002  on  rail 
transport statistics1 shall ⌦ is to ⌫ be applied as far as the information is available. 

1.Indicators relating to accidents 

1.1. Total and relative (to train-kilometres) number of significant accidents and a break-down 
on the following types of accidents ⌦ accident ⌫ : 

(i) 

collisions  ⌦ collision ⌫  of  trains  ⌦ with  rail  vehicles ⌫  ,  including  collisions 
with obstacles within the clearance gauge, 

⌦ (ii)  collision of trains, with obstacle within the clearance gauge, ⌫ 

(iii) 

(iv) 

(v) 

(vi) 

(vii) 

derailments ⌦ derailment ⌫ of trains, 

level crossing accidents, including accidents involving pedestrians at level crossings, 

accidents  to  persons  caused  by  ⌦ involving ⌫  rolling  stock  in  motion,  with  the 
exception of suicides, 

fires in rolling stock, 

others ⌦ other ⌫ . 

Each significant accident shall ⌦ is to ⌫ be reported under the type of the primary accident, 
even if the consequences of the secondary accident are  more  severe, e.g. for example a fire 
following a derailment. 

1.2. Total and relative (to train-kilometres) number of persons seriously injured and killed by 
type of accident divided into the following categories: 

(i) 

(ii) 

(iii) 

(iv) 

passengers ⌦ passenger ⌫ (also in relation to total number of passenger-kilometres 
and passenger train-kilometres), 

employees ⌦ employee ⌫ including the staff of contractors, 

level crossing users, 

unauthorised persons on railway premises ⌦ trespassers ⌫ , 

1 

OJ L 14, 21.1.2003, p. 1. 

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(v) 

others ⌦ other ⌫ . 

2.Indicators relating to dangerous goods 

Total  and  relative  (to  train-kilometres)  number  of  accidents  involving  the  transport  of 
dangerous goods divided into the following categories: 

(i) 

accidents  involving  at  least  one  railway  vehicle  transporting  dangerous  goods,  as 
defined by the Appendix, 

(ii) 

number of such accidents in which dangerous goods are released. 

3.Indicators relating to suicides 

Total and relative (to train-kilometres) number of suicides. 

4.Indicators relating to precursors of accidents 

Total and relative (to train-kilometres) number of: 

(i) 

(ii) 

(iii) 

(iv) 

(v) 

broken rails, 

track buckles ⌦ and track misalignments ⌫ , 

wrong-side signalling failures, 

signals passed at danger, 

broken wheels and axles on rolling stock in service, 

⌦ (vi)  broken axles on rolling stock in service. ⌫ 

All  precursors  are  to  be  reported,  both  resulting  and  not  resulting  in  accidents.  Precursors 
resulting  in  an  accident  shall  ⌦ are  to ⌫  be  reported  under  the  CSIs  on  precursors;  the 
accidents  that  occurred,  if  significant,  shall  ⌦ are  to ⌫  be  reported  under  the  CSIs  on 
accidents referred to in heading 1. 

5. Indicators to calculate the economic impact of accidents 

Total in euro and relative (to train-kilometres): 

– 

– 

– 

– 

number  of  deaths  and  serious  injuries  multiplied  by  the  Value  of  Preventing  a 
Casualty (VPC), 

cost of damages to environment, 

cost of material damages to rolling stock or infrastructure, 

cost of delays as a consequence of accidents. 

Safety  authorities  shall  report  either  the  economic  impact  of  all  accidents,  or  the  economic 
impact of significant accidents only. This choice shall be clearly indicated in the annual report 
referred to in Article 18. 

The VPC is the value society attributes to the prevention of a casualty and as such shall not 
form a reference for compensation between parties involved in accidents. 

The Agency shall define unit costs on the basis of data collected until the entry into force of 
this Directive. 

(cid:216) new 

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(cid:208) 2009/149/EC Art. 1 and Annex 
(adapted) 

6. Indicators relating to technical safety of infrastructure and its implementation 

6.1. Percentage of tracks with Automatic Train Protection (ATP) in operation, percentage of 
train-kilometres using operational ATP systems. 

6.2. Number of level crossings (total, per line kilometre and track kilometre) by the following 
eight types: 

(a) active level crossings with: 

(i) 

automatic user-side warning, 

(ii) 

automatic user-side protection, 

(iii)  automatic user-side protection and warning, 

(iv)  automatic  user-side  protection  and  warning,  and  ⌦ interlocked ⌫  rail-side 

protection, 

(v)  manual user-side warning, 

(vi)  manual user-side protection, 

(vii)  manual user-side protection and warning; 

(b) passive level crossings. 

7. Indicators relating to the management of safety 

Internal audits accomplished by infrastructure managers and railway undertakings as set out 
in the documentation of the safety management system. Total number of audits accomplished 
and the number as a percentage of audits required (and/or planned). 

8. Definitions 

Common definitions for the CSIs and methods to calculate the economic impact of accidents 
are laid down in the Appendix. 

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Appendix 

COMMON  DEFINITIONS  FOR  THE  CSIS  AND  METHODS  TO  CALCULATE  THE  ECONOMIC  IMPACT  OF 
ACCIDENTS 

1. Indicators relating to accidents 

1.1.  ‘significant  accident’  means  any  accident  involving  at  least  one  rail  vehicle  in  motion, 
resulting in at least one killed or seriously injured person, or in significant damage to stock, 
track,  other  installations  or  environment,  or  extensive  disruptions  to  traffic.  Accidents  in 
workshops, warehouses and depots are excluded. 

1.2.  ‘significant  damage  to  stock,  track,  other  installations  or  environment’  means  damage 
that is equivalent to EUR 150000 or more. 

1.3.  ‘extensive  disruptions  to  traffic’  means  that  train  services  on  a  main  railway  line  are 
suspended for six hours or more. 

1.4.  ‘train’  means  one  or  more  railway  vehicles  hauled  by  one  or  more  locomotives  or 
railcars, or one railcar travelling alone, running under a given number or specific designation 
from an initial fixed point to a terminal fixed point. A light engine, i.e. such as a locomotive 
travelling on its own, is considered to be a train. 

1.5. ‘collision of trains, including collisions with obstacles within the clearance gauge’ means 
a front to front, front to end or a side collision between a part of a train and a part of another 
train, or with ⌦ train or rail vehicle, or with shunting rolling stock ⌫ : 

(i) shunting rolling stock, 

(ii) objects fixed or temporarily present on or near the track (except at level crossings 
if lost by a crossing vehicle or user). 

⌦ 1.6. ‘collision with obstacles within the clearance gauge mens a collision between a part 
of  a  train  and  objects  fixed  or  temporarily  present  on  or  near  the  track  (except  at  level 
crossings if lost by a crossing vehicle or user). Collision with overhead contact lines shall be 
included. ⌫ 

1.67 ‘train derailment’ means any case in which at least one wheel of a train leaves the rails. 

1.78.  ‘level  crossing  accidents’  means  accidents  at  level  crossings  involving  at  least  one 
railway vehicle and one or more crossing vehicles, other crossing users such as pedestrians or 
other objects temporarily present on or near the track if lost by a crossing vehicle/user. 

1.89.  ‘accidents  to  persons  caused  by  ⌦ involving ⌫  rolling  stock  in  motion’  means 
accidents  to  one  or  more  persons  who  are  either  hit  by  a  railway  vehicle  or  by  an  object 
attached  to,  or  that  has  become  detached  from,  the  vehicle.  Persons  who  fall  from  railway 
vehicles are included, as well as persons who fall or are hit by loose objects when travelling 
on board vehicles. 

1.910.  ‘fires  in  rolling  stock’  means  fires  and  explosions  that  occur  in  railway  vehicles 
(including their load) when they are running between the departure station and the destination, 
including when stopped at the departure station, the destination or intermediate stops, as well 
as during re-marshalling operations. 

1.1011.  ‘other  types  of  ⌦ accident ⌫  accidents’  means  all  accidents  other  than  those 
already mentioned (train collisions, train derailments, at level crossing, to persons caused by 
rolling stock in motion and fires in rolling stock). 

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1.1112.  ‘passenger’  means  any  person,  excluding  members  of  the  train  crew,  who  makes  a 
trip  by  rail.  For  accident  statistics,  passengers  trying  to  embark/disembark  onto/from  a 
moving train are included. 

1.1213. ‘ ⌦ employee ⌫ employees (staff of contractors and self-employed contractors are 
included)’  means  any  person  whose  employment  is  in  connection  with  a  railway  and  is  at 
work at the time of the accident. It includes the crew of the train and persons handling rolling 
stock and infrastructure installations. 

1.1314. ‘level crossing ⌦ user ⌫ users’ means all ⌦ any person ⌫ persons using a level 
crossing to cross the railway line by any mean of transport or by foot. 

1.1415.  ‘unauthorised  persons  on  railway  premises’  ⌦ ‘trespasser’ ⌫  means  any  person 
present  on  railway  premises  where  such  presence  is  forbidden,  with  the  exception  of  level 
crossing users. 

1.1516.  ‘others  (third  parties)’  means  all  persons  not  defined  as  ‘passengers’,  ‘employees 
including the staff of contractors’, ‘level crossing ⌦ user ⌫ users’ or ‘unauthorised persons 
on railway premises’ ⌦ ‘trespassers’ ⌫ . 

1.1617. ‘ ⌦ death ⌫ deaths (killed person)’ means any person killed immediately or dying 
within 30 days as a result of an accident, excluding suicides. 

1.1718.  ‘injuries  ⌦ injured ⌫  (seriously  injured  person)’  means  any  person  injured  who 
was  hospitalised  for  more  than  24  hours  as  a  result  of  an  accident,  excluding  attempted 
suicides. 

2. Indicators relating to dangerous goods 

2.1. ‘accident involving the transport of dangerous goods’ means any accident or incident that 
is subject to reporting in accordance with RID1/ADR section 1.8.5. 

2.2. ‘dangerous goods’ means those substances and articles the carriage of which is prohibited 
by RID, or authorised only under the conditions prescribed therein. 

3. Indicators relating to suicides 

3.1.  ‘suicide’  means  an  act  to  deliberately  injure  oneself  resulting  in  death,  as  recorded  and 
classified by the competent national authority. 

4. Indicators relating to precursors of accidents 

4.1.  ‘broken  rail  rails’  means  any  rail  which  is  separated  in  two  or  more  pieces,  or  any  rail 
from which a piece of metal becomes detached, causing a gap of more than 50 mm in length 
and more than 10 mm in depth on the running surface. 

4.2.  ‘track  ⌦ buckle  and  track  misalignment ⌫  buckles’  means  faults  related  to  the 
continuum and the geometry of track, requiring track obstruction or immediate reduction of 
permitted speed to maintain safety. 

4.3. ‘wrong side signalling failure’ means any ⌦ technical ⌫ failure of a signalling system 
(either to infrastructure or to rolling stock), resulting in signalling information less restrictive 
than that demanded. 

1 

RID, Regulations concerning the International Carriage of Dangerous Goods by Rail, as adopted under 
Directive  2008/68/EC  of  the  European  Parliament  and  of  the  Council  of  24  September  2008  on  the 
inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13). 

EN 

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4.4. ‘Signal Passed at Danger (SPAD)’ means any occasion when any part of a train proceeds 
beyond its authorised movement. 

Unauthorised movement means to pass: 

– 

– 

– 

– 

a  trackside  colour  light  signal  or  semaphore  at  danger,  order  to  STOP,  where  an 
Automatic Train Control System (ATCS) or ATP system is not operational, 

the end of a safety related movement authority provided in an ATCS or ATP system, 

a point communicated by verbal or written authorisation laid down in regulations, 

stop boards (buffer stops are not included) or hand signals. 

Cases  in  which  vehicles  without  any  traction  unit  attached  or  a  train  that  is  unattended  run 
away past a signal at danger are not included. Cases in which, for any reason, the signal is not 
turned to danger in time to allow the driver to stop the train before the signal are not included. 

National safety authorities Safety Authorities may report separately on the four indexes and 
shall ⌦ must ⌫ report at least an aggregate indicator containing data on all four items. 

4.5.  ‘broken  ⌦ wheel ⌫  wheels  and  broken  axles’  means  a  break  affecting  the  essential 
parts of the wheel or the axle and creating a risk of accident (derailment or collision). 

⌦ 4.6 ‘broken axle’ means a break affecting the essential parts of the axle creating a risk of 
accident (derailment or collision). ⌫ 

5. Common methodologies to calculate the economic impact of accidents 

The  Agency  shall  develop  a  methodology  for  calculation  of  the  unit  costs  starting  from  the 
data collected before the entry into force of this Directive 

(cid:216) new 

(cid:208) 2009/149/EC Art. 1 and Annex 
(adapted) 

5.1. The Value of Preventing a Casualty (VPC) is composed of: 

1.  Value  of  safety  per  se:  Willingness  to  Pay  (WTP)  values  based  on  stated 

preference studies carried out in the Member State for which they are applied. 

2.  Direct and indirect economic costs: cost values appraised in the Member State, 

composed of: 

– 

– 

– 

medical and rehabilitation cost, 

legal  court  cost,  cost  for  police,  private  crash  investigations,  the 
emergency service and administrative costs of insurance, 

production losses: value to society of goods and services that could have 
been produced by the person if the accident had not occurred. 

5.2.  Common  principles  to  appraise  the  value  of  safety  per  se  and  direct/indirect  economic 
costs: 

For the value of safety per se, the assessment of whether available estimates are appropriate 
or not shall be based on the following considerations: 

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– 

– 

– 

estimates  shall  relate  to  a  system  for  valuation  of  mortality  risk  reduction  in  the 
transport sector and follow a WTP approach according to stated preference methods, 

the  respondent  sample  used  for  the  values  shall  be  representative  of  the  population 
concerned. In particular, the sample has to reflect the age/income distribution along 
with other relevant socio-economic/demographic characteristics of the population, 

method  for  eliciting  WTP  values:  survey  design  shall  be  such  that  questions  are 
clear/meaningful to respondents. 

Direct and indirect economic costs shall be appraised on the basis of the real costs borne by 
society. 

5.3.  ‘Cost  of  damage  to  environment’  means  costs  that  are  to  be  met  by  Railway 
Undertakings/Infrastructure Managers, appraised on the basis of their experience, in order to 
restore the damaged area to its state before the railway accident. 

5.4. ‘Cost of material damage to rolling stock or infrastructure’ means the cost of providing 
new rolling stock or infrastructure, with the same functionalities and technical parameters as 
that damaged beyond repair, and the cost of restoring repairable rolling stock or infrastructure 
to 
estimated  by  Railway 
Undertakings/Infrastructure  Managers  on  the  basis  of  their  experience.  Also  includes  costs 
related to leasing rolling stock, as a consequence of non availability due to damaged vehicles. 

accident.  Both 

state  before 

to  be 

the 

are 

its 

5.5.  ‘Cost  of  delays  as  a  consequence  of  accidents’  means  the  monetary  value  of  delays 
incurred  by  users  of  rail  transport  (passengers  and  freight  customers)  as  a  consequence  of 
accidents, calculated by the following model: 

VT 

=  monetary value of travel time savings 

Value of time for a passenger of a train (an hour) 

VTP = [VT of work passengers]*[Average percentage of work passengers per 
year] + [VT of non-work passengers]*[Average percentage of non-work 
passengers per year] 

VT measured in EUR per passenger per hour 

Value of time for a freight train (an hour) 

VTF = [VT of freight trains]*[(Tonne-Km)/(Train-Km)] 

VT is measured in EUR per freight tonne per hour 

Average tonnes of goods transported per train in one year = (Tonne-
Km)/(Train-Km) 

CM 

= 

Cost of 1 minute of delay of a train 

Passenger train 

CMP = K1*(VTP/60)*[(Passenger-Km)/(Train-Km)] 

Average number of passengers per train in one year = (Passenger-Km)/(Train-
Km) 

Freight train 

CMF = K2* (VTF/60) 

Factors K1 and K2 are between the value of time and the value of delay, as 

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estimated by stated preference studies, to take into account that the time lost as 
a result of delays is perceived significantly more negatively than normal travel 
time. 

Cost of delays of an accident = CMP*(Minutes of delay of passenger trains) + 
CMF*(Minutes of delay of freight trains) 

Scope of the model 

Cost of delays is to be calculated for all accidents, both significant and non-significant. 

Delays are to be calculated as follows: 

– 

– 

real delays on the railway lines where accidents occurred,  

real delays or, if not possible, estimated delays on the other affected lines. 

6. Indicators relating to technical safety of infrastructure and its implementation 

6.1.  ‘Automatic  Train  Protection  (ATP)’  means  a  system  that  enforces  obedience  to  signals 
and speed restrictions by speed supervision, including automatic stop at signals. 

6.2.  ‘level  crossing’  means  any  level  intersection  between  the  railway  and  a  passage,  as 
recognised  by  the  infrastructure  manager  and  open  to  public  or  private  users.  Passages 
between platforms within  stations are excluded, as well as passages over tracks for the sole 
use of employees. 

6.3.  ‘passage’  means  any  public  or  private  road,  street  or  highway,  including  footpaths  and 
bicycle  paths,  or  other  route  provided  for  the  passage  of  people,  animals,  vehicles  or 
machinery. 

6.4. ‘active level crossing’ means a level crossing where the crossing users are protected from 
or warned of the approaching train by the activation of devices when it is unsafe for the user 
to traverse the crossing. 

– 

Protection by the use of physical devices: 

– 

– 

half or full barriers, 

gates. 

– 

Warning by the use of fixed equipment at level crossings: 

– 

– 

– 

visible devices: lights, 

audible devices: bells, horns, klaxons, etc., 

physical devices, e.g. vibration due to road bumps. 

Active level crossings are classified as: 

1.  ‘Level  crossing  with  crossing-user-side  automatic  protection  and/or  warning’ 
means a level crossing where the crossing protection and/or warning are activated by 
the approaching train ⌦ or where there is interlocked rail-side protection ⌫ . 

These level crossings are classified as: 

(i) 

automatic user-side warning, 

(ii) 

automatic user-side protection, 

(iii)  automatic user-side protection and warning, 

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(iv)  automatic user-side protection and warning, and rail-side protection. 

‘⌦ Interlocked ⌫  Rail-side  protection’  means  a  signal  or  other  train 
protection  system  that  only  permits  a  train  to  proceed  if  the  level  crossing  is 
user-side protected and free from incursion; the latter by means of surveillance 
and/or obstacle detection. 

2.‘Level crossing with crossing-user-side manual protection and/or warning’ means a 
level  crossing  where  protection  and/or  warning  is  manually  activated  ⌦ by  a 
railway  employee ⌫  and  there  is  not  an  interlocked  ⌦ rail-side  protection ⌫ 
railway  signal  showing,  to  the  train,  a  running  aspect  only  when  protection  and/or 
warning of level crossing are activated. 

These level crossings are classified as: 

(v) manual user-side warning, 

(vi) manual user-side protection, 

(vii) manual user-side protection and warning. 

6.5.  ‘Passive  level  crossing’  means  a  level  crossing  without  any  form  of  warning  system 
and/or protection activated when it is unsafe for the user to traverse the crossing. 

7. Indicators relating to the management of safety 

7.1.  ‘audit’  means  a  systematic,  independent  and  documented  process  for  obtaining  audit 
evidence  and  evaluating  it  objectively  to  determine  the  extent  to  which  audit  criteria  are 
fulfilled. 

8. Definitions of the scaling bases 

8.1.  ‘train-km’  means  the  unit  of  measure  representing  the  movement  of  a  train  over  one 
kilometre. The distance used is the distance actually run, if available, otherwise the standard 
network  distance  between  the  origin  and  destination  shall  ⌦ is  to ⌫  be  used.  Only  the 
distance  on  the  national  territory  of  the  reporting  country  shall  ⌦ is  to ⌫  be  taken  into 
account. 

8.2. ‘passenger-km’ means the unit of measure representing the transport of one passenger by 
rail  over  a  distance  of  one  kilometre.  Only  the  distance  on  the  national  territory  of  the 
reporting country shall ⌦ is to ⌫ be taken into account. 

8.3.  ‘line  km’  means  the  length  measured  in  kilometres  of  the  railway  network  in  Member 
States,  whose  scope  is  laid  down  in  Article  2.  For  multiple-track  railway  lines,  only  the 
distance between origin and destination is to be counted. 

8.4. ‘track km’ means the length measured in kilometres of the railway network in Member 
States, whose scope is laid down in Article 2. Each track of a multiple-track railway line is to 
be counted. 

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(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 

ANNEX II 

NOTIFICATION OF NATIONAL SAFETY RULES 

National  safety  rules  that  are  to  be  notified  to  the  Commission  according  to  the  procedure 
described in Article 8 include: 

1. 

rules concerning existing national safety targets and safety methods; 

rules  concerning  requirements  on  safety  management  systems  and  safety 

2. 
certification of railway undertakings; 

--- 

(cid:208) 2008/110/EC Art. 1.13 

(cid:208) Corrigendum, OJ L 220, 
21.6.2004, p. 16 

4. common operating rules of the railway network that are not yet covered by TSIs, 
including rules relating to the signalling and traffic management system; 

5.  rules  laying  down  requirements  on  additional  internal  operating  rules  (company 
rules) that must be established by infrastructure managers and railway undertakings; 

6.  rules  concerning  requirements  on  staff  executing  safety  critical  tasks,  including 
selection  criteria,  medical  fitness  and  vocational  training  and  certification  as  far  as 
they are not yet covered by a TSI; 

7. rules concerning the investigation of accidents and incidents. 

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ANNEX III 

SAFETY MANAGEMENT SYSTEMS 

1. REQUIREMENTS ON THE SAFETY MANAGEMENT SYSTEM 

The  safety  management  system  must  be  documented  in  all  relevant  parts  and  shall  in 
particular  describe  the  distribution  of  responsibilities  within  the  organisation  of  the 
infrastructure  manager  or  the  railway  undertaking.  It  shall  show  how  control  by  the 
management on different levels is secured, how staff and their representatives on all levels are 
involved and how continuous improvement of the safety management system is ensured. 

2. BASIC ELEMENTS OF THE SAFETY MANAGEMENT SYSTEM 

The basic elements of the safety management system are: 

(a) 

(b) 

(c) 

a safety policy approved by the organisation's chief executive and communicated to 
all staff; 

qualitative  and  quantitative  targets  of  the  organisation  for  the  maintenance  and 
enhancement of safety, and plans and procedures for reaching these targets; 

procedures to meet existing, new and altered technical and operational standards or 
other prescriptive conditions as laid down 

– 

or 

– 

or 

– 

or 

– 

in TSIs, 

in national safety rules referred to in Article 8 and Annex II, 

in other relevant rules, 

in authority decisions, 

and  procedures  to  assure  compliance  with  the  standards  and  other  prescriptive 

conditions throughout the life-cycle of equipment and operations; 

procedures  and  methods  for  carrying  out  risk  evaluation  and  implementing  risk 
control  measures  whenever  a  change  of  the  operating  conditions  or  new  material 
imposes new risks on the infrastructure or on operations; 

provision  of  programmes  for  training  of  staff  and  systems  to  ensure  that  the  staff's 
staff’s competence is maintained and tasks carried out accordingly; 

arrangements for the provision of sufficient information within the organisation and, 
where appropriate, between organisations operating on the same infrastructure; 

procedures  and  formats  for  how  safety  information  is  to  be  documented  and 
designation of procedure for configuration control of vital safety information; 

procedures  to  ensure  that  accidents,  incidents,  near  misses  and  other  dangerous 
occurrences  are  reported,  investigated  and  analysed  and  that  necessary  preventive 
measures are taken; 

provision of plans for action and alerts and information in case of emergency, agreed 
upon with the appropriate public authorities; 

(d) 

(e) 

(f) 

(g) 

(h) 

(i) 

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65 

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(j) 

provisions for recurrent internal auditing of the safety management system. 

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ANNEX IV 

DECLARATIONS FOR NETWORK SPECIFIC PART OF SAFETY CERTIFICATE 

The  following  documents  must  be  submitted  to  enable  the  safety  authority  to  deliver  the 
network-specific part of the safety certificate: 

– 

– 

– 

documentation from the railway undertaking on the TSIs or parts of TSIs and, where 
relevant, national safety rules and other rules applicable to its operations, its staff and 
its rolling stock and how compliance is ensured by the safety management system, 

documentation  from  the  railway  undertaking  on  the  different  categories  of  staff 
employed  or  contracted  for  the  operation,  including  evidence  that  they  meet 
requirements of TSIs or national rules and have been duly certified, 

documentation  from  the  railway  undertaking  on  the  different  types  of  rolling  stock 
used  for  the  operation,  including  evidence  that  they  meet  requirements  of  TSIs  or 
national rules and have been duly certified. 

To  avoid  duplication  of  work  and  to  reduce  the  amount  of  information  only  summary 
documentation  should  be  submitted  concerning  elements  that  comply  with  TSIs  and  other 
requirements of Directives 96/48/EC and 2001/16/EC. 

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PRINCIPAL CONTENT OF ACCIDENT AND INCIDENT INVESTIGATION 
REPORT 

ANNEX V 

1. SUMMARY 

The  summary  shall  contain  a  short  description  of  the  occurrence,  when  and  where  it  took 
place and its consequences. It shall state the direct causes as well as contributing factors and 
underlying  causes  established  by  the  investigation.  The  main  recommendations  shall  be 
quoted and information shall be given on the addressees. 

2. IMMEDIATE FACTS OF THE OCCURRENCE 

1. The occurrence: 

– 

– 

– 

date, exact time and location of the occurrence, 

description of the events and the accident site including the efforts of the rescue and 
emergency services, 

the  decision  to  establish  an  investigation,  the  composition  of  the  team  of 
investigators and the conduct of the investigation. 

2. The background to the occurrence: 

– 

– 

– 

– 

– 

– 

– 

staff and contractors involved and other parties and witnesses, 

the  trains  and  their  composition  including  the  registration  numbers  of  the  items  of 
rolling stock involved, 

the  description  of  the  infrastructure  and  signalling  system  -  track  types,  switches, 
interlocking, signals, train protection, 

means of communication, 

works carried out at or in the vicinity of the site, 

trigger of the railway emergency plan and its chain of events, 

trigger  of  the  emergency  plan  of  the  public  rescue  services,  the  police  and  the 
medical services and its chain of events. 

3. Fatalities, injuries and material damage: 

– 

– 

– 

passengers and third parties, staff, including contractors, 

cargo, luggage and other property, 

rolling stock, infrastructure and the environment. 

4. External circumstances: 

– 

weather conditions and geographical references. 

3. RECORD OF INVESTIGATIONS AND INQUIRIES 

1. Summary of testimonies (subject to the protection of identity of the persons): 

– 

– 

railway staff, including contractors, 

other witnesses. 

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2. The safety management system: 

– 

– 

– 

– 

the framework organisation and how orders are given and carried out, 

requirements on staff and how they are enforced, 

routines for internal checks and audits and their results, 

interface between different actors involved with the infrastructure. 

3. Rules and regulations: 

– 

– 

relevant Community and national rules and regulations, 

other  rules  such  as  operating  rules, 
maintenance prescriptions and applicable standards. 

local 

instructions,  staff  requirements, 

4. Functioning of rolling stock and technical installations: 

– 

– 

– 

– 

signalling  and  control  command  system,  including  registration  from  automatic  data 
recorders, 

infrastructure, 

communications equipment, 

rolling stock, including registration from automatic data recorders. 

5. Documentation on the operating system: 

– 

– 

– 

measures taken by staff for traffic control and signalling, 

exchange  of  verbal  messages  in  connection  with  the  occurrence,  including 
documentation from recordings, 

measures taken to protect and safeguard the site of the occurrence. 

6. Man-machine-organisation interface: 

– 

– 

– 

working time applied to the staff involved, 

medical  and  personal  circumstances  with  influence  on  the  occurrence,  including 
existence of physical or psychological stress, 

design of equipment with impact on man-machine interface. 

7. Previous occurrences of a similar character. 

4. ANALYSIS AND CONCLUSIONS 

1. Final account of the event chain: 

– 

establishing  the  conclusions  on  the  occurrence,  based  on  the  facts  established  in 
heading 3. 

2. Discussion: 

– 

analysis of the facts established in heading 3 with the aim of drawing conclusions as 
to the causes of the occurrence and the performance of the rescue services. 

3. Conclusions: 

– 

direct and immediate causes of the occurrence including contributory factors relating 
to  actions  taken  by  persons  involved  or  the  condition  of  rolling  stock  or  technical 
installations, 

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– 

– 

underlying causes relating to skills, procedures and maintenance, 

root  causes  relating  to  the  regulatory  framework  conditions  and  application  of  the 
safety management system. 

4. Additional observations: 

– 

deficiencies  and  shortcomings  established  during  the  investigation,  but  without 
relevance to the conclusions on causes. 

5. MEASURES THAT HAVE BEEN TAKEN 

– 

Record of measures already taken or adopted as a consequence of the occurrence. 

6. RECOMMENDATIONS 

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(cid:207) 

ANNEX II 

PART A 

Repealed Directive with list of the successive amendments thereto 

(referred to in Article 32) 

Directive 2004/49/EC 

(OJ L 164, 30.4.2004, p. 44) 

Directive 2008/57/EC 

(OJ L 191, 18.7.2008, p. 1) 

Directive 
2008/110/EC 

(OJ L 345, 23.12.2008, p. 62) 

Commission Directive 
2009/149/EC 

(OJ L 313, 28.11.2009, p. 65) 

Corrigendum, 
2004/49/EC 

(OJ L 220, 21.6.2004, p. 16) 

PART B 

Time limits for transposition into national law 

(referred to in Article 32) 

Directive 

Deadline for transposition 

2004/49/EC 

30 April 2006 

2008/57/EC 

19 July 2010 

2008/110/EC  24 December 2010 

2009/149/EC  18 June 2010 

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ANNEX III 

CORRELATION TABLE 

Directive 2004/49/EC 

This Directive 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14a (1) to (7) 

Article 14a (8) 

Article 15 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20  

Article 21  

Article 22 

Article 23 

Article 1 

Article 2 

Article 3 

Article 4 

Article 5 

Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Article 12 

Article 11 

Article 13 

Article 14 

Article 15 

-- 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20  

Article 21  

Article 22 

Article 23 

EN 

72 

   EN 

 
Article 24 

Article 25 

Article 26 

-- 

Article 27 

Article 28 

Article 29 

Article 30 

Article 31 

Article 32 

-- 

-- 

Article 33 

-- 

Article 34 

Article 35 

Annex I 

Annex II 

Annex III 

Annex IV 

Annex V 

-- 

Article 24 

Article 25 

-- 

Article 26 

Article 27 

-- 

-- 

-- 

Article 28 

Article 29 

Article 30 

Article 31 

Article 32 

Article 33 

Article 34 

Article 35 

Annex I 

-- 

-- 

-- 

-- 

Annex II 

EN 

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