Proposal for a Directive of the European Parliament and of the Council on the interoperability of the Community rail system
Date: 2006-12-13
Institutions: European Commission
Subjects: European Union Agency for Railways, European standard, rail network, rail transport, technical regulations, trans-European network, transport infrastructure

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 13.12.2006 
COM(2006) 783 final 

2006/0273 (COD) 

Proposal for a  

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the interoperability of the Community rail system 

(presented by the Commission) 

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1.  CONTEXT OF THE PROPOSAL 

110 

•  Grounds for and objectives of the proposal 

The  aim  of  simplifying  and  modernising  the  regulatory  environment  in  Europe  is 
central  to  the  work  of  the  Commission.  Meeting  this  cross-cutting  strategic  objective 
has  led  the  Commission  to  develop  and  pursue  a  far-reaching  Better  Regulation 
agenda, with a view to making further progress towards the Lisbon objectives for jobs 
and growth. It is in this framework that the consolidation and merger of the Directives 
on railway interoperability are proposed. 

National  procedures for the approval of locomotives are currently  regarded as  one of 
the biggest barriers to the creation of new railway companies in the freight sector and a 
major  obstacle  to  the  interoperability  of  the  European  railway  system.  Since  no 
Member State can decide on its own that the authorisation for placing in service which 
it issues will be valid on the territory of other Member States, a Community initiative is 
needed to harmonise national procedures, simplify them and apply more systematically 
the principle of mutual recognition.  

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•  Background 

The proposal is part of a wider initiative designed to improve the technical part of the 
regulatory  framework  for  rail,  namely  the  Railway  Interoperability  Directives,  the 
Railway Safety Directive and the Agency Regulation.  

Firstly,  a  matter  of  central  importance  which  still  has  to  be  improved  in  order  to 
facilitate  the  free  movement  of  trains  is  the  procedure  for  approving  locomotives. 
According to the manufacturers and the railway companies, often these procedures are 
still very long and very expensive; in their view, certain requests from the competent 
authorities have little justification on a purely technical level.  

Secondly,  as  part  of  the  programme  for  simplifying  legislation,  the  Commission 
intends to consolidate and merge the Railway Interoperability Directives.  

Thirdly, with its ten years' experience of implementing the Interoperability Directives, 
the Commission has a duty to propose several improvements to the technical part of the 
regulatory framework.  

This  proposal  concerns  the  consolidation,  recasting  and  integration  of  the  Railway 
Interoperability  Directives.  It  should  be  read  with  the  joint  proposals  on  amending 
Regulation  (EC)  No  881/2004  establishing  a  European  Railway  Agency  (hereinafter 
referred to as "the Agency") and Directive 2004/49/EC on safety on the Community's 
railways. 

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•  Existing provisions in the area of the proposal 

The proposal concerns the recasting and merger of the following Directives: 

-  COUNCIL  DIRECTIVE  96/48/EC  of  23  July  1996  on  the  interoperability  of  the 
trans-European  high-speed  rail  system  (OJ  L  235,  17.9.1996,  p.  6)  as  amended  by 
Regulation  (EC)  No  1882/2003  of  the  European  Parliament  and  of  the  Council  of 

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29 September 2003 (OJ L 284 of 31.10.2003, p. 1) 

-  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  system  (OJ  L  110,  20.4.2001,  p.  1),  as  corrected  by  OJ  L  334, 
18.12.2001, p. 34 (2001/16/EC). 

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•  Consistency with other policies and objectives of the Union 

Simplification  of  the  procedures  for  placing  rolling  stock  in  service  makes  rail 
transport more competitive. By reducing the costs of the transport chain, it contributes 
to the competitiveness of industry as a whole in the European Union. A dynamic rail 
sector  also  reinforces  the  European  railway  industry's  position  as  world  leader  and 
safeguards jobs in the sector. More competitive rail transport will also contribute to the 
European  Union's  basic  commitments  as  regards  sustainable  development  and 
addressing climate change.  

Consequently,  this  initiative  forms  part  of  the  revised  Growth  and  Jobs  Strategy. 
Furthermore, it makes it possible to reduce the administrative costs associated with the 
activities of the national safety authorities. 

2.  CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

•  Consultation of interested parties 

211 

Consultation methods, main sectors targeted and general profile of respondents 

The  Commission  prepared  a  consultative  document  in  2006  which  identified  several 
options and presented it to all the parties concerned (national authorities responsible for 
railway  safety,  industry,  operators,  infrastructure  managers,  European  standardisation 
bodies,  etc.)  at  a  workshop.  Written  positions  were  collected  from  all  parties  and 
examined as part of an impact study prepared in accordance with current standards.  

212 

Summary of responses and how they have been taken into account 

The  Commission  took  account  of  the  different  opinions  in  drawing  up  its  proposal, 
which  pursues  a  twofold  objective:  first,  to  launch  work  that  can  be  undertaken 
straightaway  without  waiting  for  new  legislative  provisions  to  enter  into  force  and, 
second, to amend the legislation so as to provide a sure legal framework for assigning 
rights  and  responsibilities  to  the  parties  concerned  by  the  authorisation  procedure  for 
placing railway rolling stock in service.  

•  Collection and use of expertise 

221 

Scientific/expertise domains concerned 

National procedures for the approval of railway rolling stock, national technical and/or 
safety rules, costs and time limits associated with these procedures, etc. 

222 

Methodology used 

The Commission guidelines of 15 June 2005 (SEC(2005)791), which were updated in 

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2006, were used. 

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Main organisations/experts consulted 

The  expertise  of  the  European  Railway  Agency  was  used  in  evaluating  the  various 
positions  expressed  by  sector  stakeholders  and  in  assessing  the  impact  of  the  various 
options.  

2249 

Summary of advice received and used 

The  existence  of  potentially  serious  risks  with  irreversible  consequences  was  not 
mentioned. 

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Please refer to the impact assessment. 

Means used to make the expert advice publicly available 

The impact assessment is published on the Internet. 

•  Impact assessment 

Baseline scenario: to restrict ourselves to applying existing legislation and intervening 
only when complaints are made.  

Non-regulatory  options:  to  publish  the  working  group's  recommendations  on  existing 
cross-acceptance of rolling stock and to ask Member States to apply them, to ask the 
Agency  to  classify  national  rules  and  to  identify  equivalences,  to  ask  the  Agency  to 
assume  an  advisory  or  appellate  role  in  the  national  approval  procedures  for  placing 
into service, to speed up the development and review of European standards, to verify 
that the principle of mutual recognition is being applied properly and, if necessary, to 
launch infringement proceedings.  

Regulatory options: To amend legislation in order to: make it unnecessary for operators 
to  obtain  authorisation  in  each  Member  State,  to  clarify  the  procedure  for  existing 
rolling  stock,  to  enable  the  Agency  to  issue  authorisations  for  placing  in  service,  to 
enable the Agency to assume a coordination, advisory and/or appellate role, to enable 
the  bodies  responsible  for  verifying  conformity  to  issue  authorisations  for  placing  in 
service, to enable infrastructure managers to issue authorisations for placing in service. 

The Commission has carried out an impact assessment as provided for in its Legislative 
and 
at 
http://ec.europa.eu/transport/rail/index_en.html. 

Programme. 

report 

found 

Work 

The 

can 

be 

3.  LEGAL ELEMENTS OF THE PROPOSAL 

•  Summary of the proposed action 

It  is  proposed  to  simplify  the  procedure  for  placing  in  service.  For  wagons  and 
passenger carriages placed in service after this Directive has entered into force, a single 
authorisation  for  placing  in  service  issued  by  one  Member  State  of  the  Community 
should suffice. In the case of rolling stock placed in service before this Directive enters 
into force and not bearing an "EC" declaration of verification, it should be made clear 

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that the Railway Safety Directive applies. In the case of rolling stock bearing an "EC" 
declaration of verification as provided for in Article 18, the only criteria which a safety 
authority  may  check  with  a  view  to  issuing  an  authorisation  for  placing  in  service 
should  be  comprehensively  identified.  In  the  case  of  vehicle  series  produced  from  a 
type,  Member  States  should  be  allowed  to  issue  batch  authorisations  for  placing  in 
service. 

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•  Legal basis 

Articles 71 and 156. 

•  Subsidiarity principle 

The principle of subsidiarity applies in so far as the proposal does not concern an area 
in which the Community has exclusive competence. 

The  objectives  of  the  proposal  cannot  be sufficiently  achieved  by  the  Member  States 
for the following reasons. 

This  initiative  is  part  of  a  set  of  proposals  aimed  at  resolving  the  problem  of  rolling 
stock for which placing in service has been authorised in one Member State but which 
is  not  automatically  accepted  in  another  Member  State.  This  problem  has  a 
transnational dimension which cannot be addressed by a national initiative because no 
Member  State can  authorise the placing in  service  of  rolling stock  on  the  territory of 
another  Member  State.  Moreover,  it  is  for  the  Commission  to  put  forward  proposals 
concerning simplification of the acquis communautaire.  

The  objectives  of  the  proposal  can  be  better  achieved  by  Community  action  for  the 
following reasons. 

The  territoriality  principle  which  applies  to  authorisations  for  placing  in  service  is 
provided  for  by  the  Interoperability  Directives  and  the  Railway  Safety  Directive. 
Furthermore,  action  taken  only  at  national  level  cannot  achieve  the  objective  of  this 
proposal.  

The duration and costs of rolling-stock approval are the most useful indicators of the 
achievement of the objectives pursued by this proposal.  

The  amendment  of  Article  14  of  the  Interoperability  Directives  as  merged  in  this 
proposal  makes  it  possible  to  specify  the  part  of  an  authorisation  which  should  be 
mutually  recognised  and  to  simplify  the  procedure  in  certain  cases.  The  option  of 
centralising  the  decision  to  authorise  a  placing  in  service,  e.g.  in  the  hands  of  the 
Agency, has not been retained; This shows that the proposal has been limited to what 
Member States cannot achieve by national initiatives.  

The proposal therefore complies with the subsidiarity principle. 

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•  Proportionality principle 

The proposal complies with the principle of proportionality for the following reasons: 

It has been drafted with a view to minimising the necessary amendments.  

It has virtually no impact on the Commission's operating budget. Only advantages are 
expected  for  the  competent  authorities  and  the  sector  itself,  since  one  of  the  main 
objectives  is  to  simplify  the  authorisation  procedure  for  placing  in  service  by 
eliminating redundant verification processes and reducing regulation.  

•  Choice of instruments 

Proposed instrument: directive. 

Other instruments would not have been appropriate for the following reasons: 

The purpose is to amend a directive. 

4.  BUDGETARY IMPLICATION 

For  the  Agency,  the  impact  will  be  less  than  €2.2  million  during  the  first  five  years; 
this will then will fall to less than €0.5 million (see the financial statement attached to 
the proposal). 

5.  ADDITIONAL INFORMATION 

•  Simplification 

The proposal simplifies the administrative procedures applicable to bodies and private 
individuals. 

Rolling stock which has already been authorised for placing in service in one Member 
State  will  only  have  to  undergo  additional  certification  in  another  Member  State  if 
there are additional national requirements (for example, because of the characteristics 
of the local network). 

The proposal is included in the Commission’s Work and Legislative Programme under 
the reference 2006/TREN/005. 

•  European Economic Area 

This  draft  instrument  concerns  a  matter  covered  by  the  EEA  Agreement  and  should 
therefore be extended to the European Economic Area. 

Detailed explanation of the proposal by chapter or by article 

1. Description of the geographical scope and extension of the scope (Article 1) 

Directive 2004/50/EC provided for the progressive extension of the scope of Directive 
2001/16/EC  as new TSIs were adopted or existing  ones  revised.  When  this  Directive 
comes into force, its scope will cover conventional and high-speed European networks 

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as defined in the Community guidelines for trans-European transport networks, and the 
rolling  stock  likely  to  travel  on  those  networks.  The  scope  will  be  progressively 
extended  to  the  whole  network  and  all  rolling  stock,  provided  that  an  impact 
assessment shows the economic benefit of so doing.  

Article 1(3) is amended to clarify the procedure to be followed for this extension: 

First, the Agency carries out an impact assessment and identifies the new TSIs which 
should be developed, or the existing ones which should be amended, to cover the lines 
and rolling stock not yet covered by existing TSIs. 

Second, 
recommendation and after receiving the opinion of the Committee.  

the  Commission  adopts  a  mandate  on 

the  basis  of 

the  Agency's 

The expanded scope requires minor drafting changes throughout the Directive. 

2. Definitions (Article 2) 

The  definition  of  basic  parameter  has  been amended, as has  Article  6(3), to do away 
with the provision requiring a Commission decision; experience has shown that such a 
decision  is  not  warranted,  since  the  specification  of  parameters  requires  an  economic 
assessment, which cannot be complete while the strategy for implementing the TSI in 
question has not been worked out. 

Three new definitions are proposed: 

"contracting entity" was not defined; this question was deliberated by the Committee, 
which  agreed  on  greater  flexibility  concerning  the  entity  which  can  launch  the  "EC" 
verification procedure or request an authorisation for placing in service; 

"keeper", which is cited in the preceding definition and which is the subject of the joint 
proposal amending the Railway Safety Directive; 

"project at an advanced stage of development".  

3. Derogations 

The application of Article 7 on derogations has been discussed on numerous occasions 
by  the  Committee  set  up  under  Article  21  of  Directive  96/48/EC.  Recommendations 
have been prepared, in particular with regard to: 

the  definition  of  a  project  "at  an  advanced  stage  of  development",  i.e.  one  which 
qualifies  for  the  "automatic"  derogation  procedure  without  a  decision  by  the 
Commission; 

the contents of the file to be notified to the Commission so that it can check whether 
such a derogation is justified. 

4. Transition period for interoperability constituents (Article 10 – new paragraph 5) 

When  a  TSI  comes  into  force,  a  number  of  interoperability  constituents  are  already 
being  manufactured.  A  transition  period  should  be  provided  for  so  that  these 

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constituents can be integrated into a subsystem even if they do not strictly conform to 
the said TSI. 

5. Technical annexes of TSIs (Article 6) 

The adoption of certain TSIs relating to high speed and to conventional rail has proved 
to  be  a  very  long  procedure  on  account  of  the  need  to  translate  the  voluminous 
technical  annexes.  The  annexes,  given  their  technical  nature,  are  likely  to  change 
quickly, especially in the field of information and telecommunications systems. This is 
the case, for example, with TSIs for control and command and signalling subsystems, 
and for telematic applications for freight and passengers. A new paragraph is proposed 
which will make it possible to decide in such cases that one or more technical annexes 
can be published by the Agency.  

6.  Checking  the  requirements  relating  to  operation  and  maintenance  after  placing  in 
service (Article 14(2)) 

After a subsystem is placed in service, care should be taken to ensure that it is operated 
and maintained in accordance with the essential requirements relating to it. Under the 
Railway Safety Directive,  responsibility for meeting these requirements lies, for their 
respective  subsystems,  with  the  infrastructure  manager  or  the  railway  company. 
Member  States  can  check  compliance  with  these  requirements  when  granting  safety 
certificates and safety approvals pursuant to Articles 10 and 11 of the Railway Safety 
Directive.  

7. Procedure for placing rolling stock in service (Article 14) 

As  far  as  rolling  stock  is  concerned,  it  is  not  economically  viable  to  require  an 
authorisation  for  placing  in  service  in  each  Member  State  for  each  vehicle.  It  is 
therefore necessary to simplify the procedure for placing in service.  

8. Specific cases and national rules (Article 16(3)) 

The interpretation of this point was also discussed by the Committee. It was agreed that 
if the specific case identified in the TSI involves national technical rules, these should 
be  notified  to  the  Commission  in  the  same  way  as  rules  applicable  in  the  case  of 
derogations or when TSIs contain "open points". 

9. Urgent amendment of a TSI (Article 17) 

The  procedure  for  reviewing  a  TSI  can  last  several  months:  adoption  by  the 
Commission  of  a  mandate  for  the  Agency;  preparation  of  a  project  by  the  Agency; 
assessment by the Commission; preparation of a Commission decision; opinion of the 
Committee; translation; Commission's internal procedure; adoption and notification to 
the Member States. The question was discussed in the Committee, and agreement was 
reached on the fact that a quicker procedure was needed for urgent cases. It is therefore 
proposed that, in such cases, a Technical Opinion should be requested from the Agency 
and that the Commission should decide if that Technical Opinion can be used pending 
the review of the TSI. 

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10. Certificate for intermediate verifications (Article 18) 

This was the subject of a proposal for the amendment of Annex VI, submitted to the 
Committee for opinion under the regulatory procedure in June 2006. The amendment 
makes  it  possible  to  acknowledge  that  the  procedure  for  verifying  a  subsystem  has 
several  stages,  and  that  the  possibility  of  issuing  such  certificates  creates  flexibility, 
which is necessary in markets of this kind. 

11. Work programme (Article 23) 

This Article has to be updated in the light of the TSIs already adopted. 

12. Infrastructure and rolling-stock registers (Article 24) 

The work done by the Agency in 2005 and 2006 on preparing the specifications of the 
national vehicles register provided for by Article 14(3) showed that it is necessary to 
clarify the scope of the various registers, their contents, interconnection and how they 
are  used  by  the  various  players:  national  safety  authority,  infrastructure  managers, 
railway  companies,  keepers,  manufacturers,  etc.  It  is  proposed  to  prepare  guidelines 
and, if necessary, adopt them formally.  

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2006/0273 (COD) 

(cid:208) 2004/50/EC Art. 2(1) (adapted) 

DIRECTIVE 2001/16/EC OF THE EUROPEAN PARLIAMENT AND OF THE 
COUNCIL 

of 19 March 2001 

on the interoperability of the conventional rail system 

(cid:208) 96/48/EC (adapted) 

COUNCIL DIRECTIVE 96/48/EC 

of 23.July.1996 

on the interoperability of the ⌦ Community ⌫ trans-European high-speed rail system 

(cid:208) 2001/16/EC (adapted) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Articles 
156 and 71 thereof, 

Having regard to the proposal from the Commission1, 

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 procedure referred to in Article 251 of the Treaty4, 

Whereas: 

1 
2 
3 
4 

OJ C 89 E, 28.3.2000, p. 11. 
OJ C 204, 18.07.2000, p. 13. 
OJ C 317, 06.11.2000, p. 22. 
Opinion of the European Parliament of 17 May 2000 (OJ C 59, 23.2.2001, p. 106), Council Common 
Position of 10 November 2000 (OJ C 23, 24.1.2001, p. 15) and Decision of the European Parliament of 
13 February 2001. 

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(1) 

(2) 

(3) 

(cid:216) new 

Council  Directive  96/48/EC  of  23  July  1996  on  the  interoperability  of  the  trans-
European  high-speed  rail  system5  and  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  system6  were  substantially  amended  in  2004.  When 
introducing new amendments, it is appropriate to recast the Directives for the sake of 
clarity  and  bring  their  provisions  together  in  a  single  instrument  with  a  view  to 
simplification. 

(cid:208) 96/48/EC recital 1 (adapted) 

Acting in accordance with the procedure laid down in Article 189c, Whereas in order 
to enable citizens of the Union, economic operators and regional and local authorities 
to benefit to the full  from  the advantages deriving from  establishing an  area without 
internal  frontiers,  it  is  advisable,  in  particular,  to  improve  the  interlinking  and 
interoperability of national high-speed train networks, as well as access thereto;  

(cid:208) 2001/16/EC recital 1 

In  order  to  enable  citizens  of  the  Union,  economic  operators  and  regional  and  local 
authorities to benefit to the full from the advantages deriving from the establishing of 
an  area  without  internal  frontiers,  it  is  appropriate,  in  particular,  to  improve  the 
interlinking and interoperability of the national rail networks as well as access thereto, 
implementing  any  measures  that  may  prove  necessary  in  the  field  of  technical 
standardisation, as provided for in Article 155 of the Treaty.  

(4) 

By signing the Protocol adopted in Kyoto on 12 December 1997 the European Union 
has undertaken to reduce its gas emissions. These objectives require an adjustment to 
the balance between the various modes of transport, and consequently an increase in 
the competitiveness of rail transport. 

(cid:208) 2001/16/EC recital 2 

(5) 

The  Council  strategy  for  the  integration  of  the  environment  and  sustainable 
development into Community transport policy highlights the need to act to reduce the 
environmental impact of transport. 

(cid:208) 2001/16/EC recital 3 

5 

6 

OJ  L 235,  17.9.1996,  p. 6.  Directive  as  last  amended  by  Directive 2004/50/EC  of  the  European 
Parliament and of the Council (OJ L 164, 30.4.2004, p. 114). 
OJ L 110, 20.4.2001, p. 1. Directive as last amended by Directive 2004/50/EC. 

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(cid:208) 96/48/EC recital 2 (adapted) 

(6)  Whereas a high-level working party consisting of representatives of the governments 
of the Member States, of the European railways and of the European railway industry 
convened by the Commission in order to meet the request expressed by the Council in 
its resolution of 4 and 5 December 1989 drew up the master plan for a European high-
speed train network; 

(7)  Whereas in December 1990 the Commission sent to the Council a communication on 
the high-speed train network, and whereas the Council gave a favourable reception to 
that communication in its resolution of 17 December 19907; 

(cid:208) 96/48/EC recital 3 (adapted) 

(8)  Whereas Article 129c of the Treaty provides that the Community shall implement any 
measures that may prove necessary to ensure network interoperability, in particular in 
the field of technical standardization; 

(cid:208) 96/48/EC recital 4 (adapted) 

(cid:208) 96/48/EC recital 5 (adapted) 

(9)  Whereas 

the  commercial  operation  of  high-speed 

requires  excellent 
compatibility between the characteristics of the infrastructure and those of the rolling 
stock;  whereas  performance  levels,  safety,  quality  of  service  and  cost  depend  upon 
such  compatibility  as  does,  in  particular,  the  interoperability  of  the  European  high-
speed rail system;  

trains 

(cid:208) 96/48/EC recital 9 (adapted) 

(10)  Whereas  national  regulations  and  the  railways'  internal  rules  and  the  technical 
specifications  which  the  railways  apply  contain  major  differences;  whereas  those 
national  regulations  and  internal  rules  incorporate  techniques  that  are  specific  to  the 
national  industries;  whereas  they  prescribe  specific  dimensions  and  devices  and 
special  characteristics;  whereas  this  situation  runs  counter  to  high-speed  trains  being 
able to run normally throughout Community territory; 

(11)  Whereas,  over  the  years,  this  situation  has  created  very  close  links  between  the 
national railway industries and the national railways, to the detriment of the genuine 
opening-up of contracts; whereas, in order to enhance their competitiveness at world 
level those industries require an open, competitive European market; 

(cid:208) 96/48/EC recital 10 (adapted) 

7 

JO no C 33 du 8. 2. 1991, p. 1. 

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(cid:208) 2001/16/EC recital 4 (adapted) 

(12)  The  commercial  operation  of  trains  throughout  the  trans-European  rail  network 
requires  in  particular  excellent  compatibility  between  the  characteristics  of  the 
infrastructure and those of the rolling stock, as well as efficient interconnection of the 
information and communication systems of the different infrastructure managers and 
operators.  Performance  levels,  safety,  quality  of  service  and  cost  depend  upon  such 
compatibility  and  interconnection,  as  does,  in  particular,  the  interoperability  of  the 
trans-European conventional rail system. 

(13)  Member  States  are  responsible  for  ensuring  compliance  with  the  safety,  health  and 
consumer  protection  rules  applying  to  the  railway  networks  in  general  during  the 
design, construction, putting into service and operation of those railways. 

(cid:208) 2001/16/EC recital 13 

(cid:208) 2001/16/EC recital 14 

(14)  There are major differences in the national regulations and internal rules and technical 
specifications  which  the  railways  apply,  since  they  incorporate  techniques  that  are 
specific  to  the  national  industries  and  prescribe  specific  dimensions  and  devices  and 
special  characteristics.  This  situation  prevents  trains  from  being  able  to  run  without 
hindrance throughout the Community network. 

(15)  Over the years, this situation has created very close links between the national railway 
industries  and  the  national  railways,  to  the  detriment  of  the  genuine  opening-up  of 
markets.  In  order  to  enhance  their  competitiveness  at  world  level,  these  industries 
require an open, competitive European market. 

(cid:208) 2001/16/EC recital 15  

(16) 

It is therefore appropriate to define basic essential requirements for the whole of the 
Community which will apply to the trans-European conventional rail system. 

(cid:208) 2001/16/EC recital 16 (adapted) 

(17)  Whereas  it  is  therefore  appropriate  to  define  essential  requirements  for  the  whole  of 
the Community which will apply to the trans-European high-speed train system; 

(cid:208) 96/48/EC recital 11 (adapted) 

EN 

13 

   EN 

 
 
 
 
 
 
 
(18)  Whereas  pursuant  to  Council  Directive  91/440/EEC  of  29  July  1991  on  the 
development  of  the  Community's  railways8  railway  companies  must  have  increased 
access to the rail networks of the Member States, which in turn requires infrastructure, 
equipment and rolling stock interoperability; 

(cid:208) 96/48/EC recital 6 (adapted) 

(cid:208) 96/48/EC recital 7 (adapted) 

(19)  Whereas the Member States are responsible for ensuring compliance with the safety, 
health  and  consumer  protection  rules  applying  to  the  railway  networks  in  general 
during  the  design,  construction,  placing  in  service  and  operation  of  those  railways; 
whereas, together with the local authorities, they also have responsibilities in respect 
of rights in land, regional planning and environmental protection; whereas that is also 
especially pertinent with regard to high-speed train networks; 

(20)  Whereas  Council  Directive  85/337/EEC  of  27  June  1985  on  the  assessment  of  the 
effects  of  certain  public  and  private  projects  on  the  environment9  requires  an 
assessment  of  the  impact  on  the  environment  of  the  construction  of  lines  for  long-
distance rail traffic; 

(cid:208) 96/48/EC recital 8 (adapted) 

(cid:208) 96/48/EC recital 12 (adapted) 

(21)  Whereas, in view of the extent and complexity of the trans-European high-speed rail 
system, it has proved necessary for practical reasons to break it down into subsystems; 
whereas for each of those subsystems the essential requirements must be specified, the 
basic parameters laid down and the technical specifications determined for the whole 
of  the  Community,  particularly  in  respect  of  constituents  and  interfaces,  in  order  to 
meet 
subsystems 
(environment,  users  and  operation)  will  be  subject  to  technical  specifications  for 
interoperability  (TSIs)  only  in  so  far  as  is  necessary  to  ensure  interoperability  in  the 
fields of infrastructure, energy, control-and-command and signalling and rolling-stock; 

requirements;  whereas,  however,  certain 

those  essential 

(cid:208) 96/48/EC recital 13 (adapted) 

(22)  Whereas  the  introduction  of  provisions  on  the  interoperability  of  the  trans-European 
high-speed  rail  system  must  not  create  unjustified  cost-benefit  barriers  to  the 
preservation of the existing rail network of each Member State, but must endeavour to 
maintain  the  objective  of  the  circulation  of  high-speed  trains  throughout  the 
Community; 

8 
9 

JO no C 237 du 24. 8. 1991, p. 25. 
JO no C 175 du 5. 7. 1985, p. 40. 

EN 

14 

   EN 

 
 
 
 
 
 
                                                 
(cid:208) 96/48/EC recital 14 (adapted) 

(23)  Whereas  individual  Member  States  should  be  allowed  not  to  apply  certain  technical 
specifications for interoperability in specific cases, provided that there are procedures 
to  ensure  that  such  possibilities  for  derogation  are  justified;  whereas  Article  129c  of 
the  Treaty  requires  the  Community's  activities  in  the  area  of  interoperability  to  take 
into account the potential economic viability of projects; 

(cid:208) 96/48/EC recital 15 (adapted) 

(24)  Whereas  in  order  to  comply  with  the  appropriate  provisions  on  government 
procurement  procedures  in  the  rail  sector  and  in  particular  Directive  93/38/EEC10, 
contracting entities must include technical specifications in the general documents or 
the contract documents relating to each contract; whereas it is necessary to build up a 
body  of  European  specifications  to  serve  as  references  for  those  technical 
specifications; 

(cid:208) 96/48/EC recital 16 (adapted) 

(25)  Whereas,  within  the  meaning  of  Directive  93/38/EEC,  a  European  specification  is  a 
common technical specification, a European technical approval or a national standard 
implementing a European standard; whereas harmonized European standards are to be 
drawn  up  by  a  European  standardization  body  such  as  the  European  Committee  for 
Standardization (CEN), the European Committee for Electrotechnical Standardization 
(CENELEC)  or  the European Telecommunications Standards Institute (ETSI), to the 
order of the Commission, and their references published in the Official Journal of the 
European Communities; 

(cid:208) 96/48/EC recital 17 (adapted) 

(26)  Whereas  it  would  be  in  the  Community's  interests  for  there  to  be  an  international 
system of standardization capable of generating standards which are actually used by 
those involved in international trade and which meet the requirements of Community 
policy;  whereas  the  European  standardization  bodies  must  therefore  continue  their 
cooperation with the international standardization bodies; 

(cid:208) 96/48/EC recital 18 (adapted) 

(27)  Whereas  contracting  entities  define  such  further  requirements  as  are  necessary  to 
complete  European  specifications  or  other  standards;  whereas  those  specifications 
must not prevent the essential requirements that have been harmonized at Community 
level and which the trans-European high-speed train system must satisfy, from being 
met; 

10 

Council  Directive  93/38/EEC  of  14  June  1993  coordinating  the  procurement  procedures  of  entities 
operating in the water, energy, transport and telecommunications sectors (OJ L 199, 9.8.1993, p. 9). 8. 
1993, p. 84), telle que modifiée par l'acte d'adhésion de 1994. 

EN 

15 

   EN 

 
 
 
 
 
 
                                                 
(cid:208) 96/48/EC recital 19 (adapted) 

(28)  Whereas  the  procedures  governing  the  assessment  of  conformity  or  of  suitability  of 
use  of  constituents  must  be  based  on  the  use  of  the  modules  covered  by  Decision 
93/465/EEC11; whereas, as far as possible and in order to promote the development of 
the industries concerned, it is appropriate to expand the procedures involving a system 
of  quality  assurance;  whereas  the  notion  of  constituent  covers  both  tangible  objects 
and intangible objects such as software; 

(29)  Whereas  the  suitability  for  use  of  the  most  critical  constituents  as  regards  safety, 

availability or system economy should be assessed; 

(cid:208) 96/48/EC recital 20 (adapted) 

(cid:208) 96/48/EC recital 21 (adapted) 

(30)  Whereas in their contract documents, contracting entities, lay down, in particular for 
constituents,  by  reference  to  the  European  specifications,  the  characteristics  which 
must be met, in contractual terms, by the manufacturers; whereas, this being the case, 
constituent  conformity  is  mainly  linked  to  their  area  of  use  in  order  to  ensure  and 
guarantee  the  interoperability of  the  system,  and  not  only  to  their  free  movement  on 
the Community market; 

(cid:208) 96/48/EC recital 22 (adapted) 

(31)  Whereas  it  is  therefore  not  necessary  for  a  manufacturer  to  affix  the  CE  mark  to 
constituents that are subject to the provisions of this Directive as, on the basis of the 
assessment of conformity and/or suitability for use conducted in accordance with the 
procedures  provided  for  that  purpose  in  the  Directive,  the  manufacturer's  declaration 
of  conformity  is  sufficient;  whereas  that  does  not  affect  the  obligation  on 
manufacturers  to  affix  the  CE  mark  to  certain  components  in  order  to  certify  their 
compliance with other Community provisions relating to them; 

(cid:208) 96/48/EC recital 23 (adapted) 

(32)  Whereas the subsystems constituting the trans-European high-speed rail system must 
be  subjected  to  a  verification  procedure;  whereas  that  verification  must  enable  the 
authorities responsible for authorizing their placing in service to be assured that at the 
stages  of  design,  construction  and  placing  in  service  the  result  is  in  line  with  the 
regulations  and  technical  operational  provisions  in  force;  whereas  that  must  also 
enable  manufacturers  to  be  able  to  count  upon  equality  of  treatment  whatever  the 
country; whereas it is therefore necessary to lay down a module defining the principles 
and conditions applying to EC verification of subsystems; 

11 

Council  Decision  93/465/EEC  of  22  July  1993  concerning  the  modules  for  the  various  phases  of  the 
conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, 
which are intended to be used in the technical harmonisation directives (OJ L 220, 30.8.1993, p. 30). 8. 
1993, p. 23. 

EN 

16 

   EN 

 
 
 
 
 
 
                                                 
(cid:208) 96/48/EC recital 24 (adapted) 

(33)  Whereas  the  EC  verification  procedure  is  based  on  TSIs;  whereas  those  TSIs  are 
drawn  up  to  the  order  of  the  Commission  by  the  joint  body  representing  the 
infrastructure  managers,  the  railway  companies  and  the  industry;  whereas  the 
reference to TSIs is required in order to ensure interoperability of the trans-European 
high-speed rail system and whereas those TSIs are subject to the provisions of Article 
18 of Directive 93/38/EEC; 

(34)  Whereas  the  notified  bodies  responsible  for  examining  the  conformity  assessment 
procedures or that applying to the use of constituents, together with the procedure for 
the  assessment  of  subsystems  must,  particularly  in  the  absence  of  any  European 
specification, coordinate their decisions as closely as possible; 

(cid:208) 96/48/EC recital 25 (adapted) 

(cid:208) 96/48/EC recital 26 (adapted) 

(35)  Whereas  Council  Directive  91/440/EEC  requires  a  separation  of  activities,  in 
accounting  terms,  between  transport  service  operation  and  those  concerning  railway 
infrastructure  management;  whereas,  this  being  the  case,  the  specialized  services 
provided by the railway infrastructure managers designated as notified bodies should 
be  structured  in  such  a  way  as  to  meet  the  criteria  which  must  apply  to  this  type  of 
body;  whereas  other  specialized  bodies  may  be  notified  where  these  meet  the  same 
criteria; 

(cid:208) 96/48/EC recital 27 (adapted) 

(36)  Whereas  interoperability  within  the  trans-European  high-speed  train  system  is 
Community  wide  in  scale;  whereas  the  Member  States  are  unable,  on  an  individual 
basis, to take the action needed in order to achieve that interoperability; whereas it is 
therefore necessary, pursuant to the principle of subsidiarity, for this action to be taken 
at Community level, 

(cid:208) 2001/16/EC recital 5 (adapted) 

(37)  To  achieve  these  objectives  an  initial  measure  was  taken  by  the  Council  on  23  July 
1996  with  the  adoption  of  Directive  96/48/EC  concerning  the  interoperability  of  the 
trans-European high-speed rail system12. ⌦ The European Parliament and the Council 
subsequently  adopted  Directive  2001/16/EC  on  the  interoperability  of  the  trans-
European conventional rail system. ⌫ 

12 

OJ L 235, 17.09.1996, p. 6. 

EN 

17 

   EN 

 
 
 
 
 
 
                                                 
(cid:208) 2004/50 recital 7 

(38)  The entry into force of Directives 2001/12/EC of the European Parliament and of the 
Council  of  26 February 2001  amending  Council  Directive 91/440/EEC  on  the 
development  of  the  Community's  railways,  2001/13/EC  of  the  European  Parliament 
and of the Council of 26 February 2001 amending Council Directive 95/18/EC on the 
licensing of railway undertakings and 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 and safety certification 
has  an  impact  on  the  implementation  of  interoperability.  As  in  the  case  of  other 
transport modes, the extension of access rights must be accompanied by the requisite 
harmonisation measures. It is therefore necessary to implement interoperability on the 
whole  network  by  extending  progressively  the  geographical  scope  of  Directive 
2001/16/EC. It is also necessary to extend the legal basis of Directive 2001/16/EC to 
Article 71 of the Treaty, on which Directive 2001/12/EC is founded. 

(cid:208) 2004/50 recital 10 

(39)  The  development  of  TSIs  in  the  high-speed  sector  has  shown  the  need  to  clarify  the 
relation between the essential requirements of Directive 96/48/EC and the TSIs on the 
one hand, and the European standards and other documents of a normative nature on 
the other. In particular, a clear distinction should be drawn between the standards or 
parts of standards which must be made mandatory in order to achieve the objectives of 
that Directive, and the «harmonised» standards that have been developed in the spirit 
of the new approach to technical harmonisation and standardisation. 

(cid:208) 2004/50 recital 11 

the  case  of 

(40)  As a rule, the European specifications are developed in the spirit of the new approach 
to technical harmonisation and standardisation. They enable a presumption to be made 
of  conformity  with  certain  essential  requirements  of  Directive 96/48/EC,  particularly 
in 
interfaces.  These  European 
specifications,  or  the  applicable  parts  thereof,  are  not  mandatory  and  no  explicit 
reference  to  these  specifications  may  be  made  in  the  TSIs.  References  to  these 
European specifications are published in the Official Journal of the European Union, 
and  Member  States  publish  the  references  to  the  national  standards  transposing  the 
European standards. 

interoperability  constituents  and 

(cid:208) 2004/50 recital 12 

(41)  TSIs  may  in  certain  cases  make  an  explicit  reference  to  European  standards  or 
specifications where this is strictly necessary in order to achieve the objectives of this 
Directive.  Such  explicit  reference  has  consequences  which  must  be  made  clear;  in 
particular,  these  European  standards  or  specifications  become  mandatory  from  the 
moment the TSI is applicable. 

EN 

18 

   EN 

 
 
 
 
 
(cid:208) 2004/50 recital 13 

(42)  The  TSI  sets  all  the  conditions  with  which  an  interoperability  constituent  must 
conform, and the procedure to be followed in assessing conformity. In addition, it is 
necessary to specify that every constituent must undergo the  procedure for assessing 
conformity and suitability for the use indicated in the TSIs and have the corresponding 
certificate. 

(cid:208) 2004/50 recital 14 

(43) 

It is necessary for safety reasons to require Member States to assign an identification 
code to each vehicle placed in service. The vehicle should then be entered in a national 
vehicle register. The registers must be open to consultation by all Member States and 
by certain Community economic players. The registers should be consistent as regards 
the  data  format.  They  should  therefore  be  covered  by  common  operational  and 
technical specifications. 

(cid:208) 2004/50 recital 15 

(44)  The  procedure  to  be  followed  in  the  case  of  essential  requirements  applicable  to  a 
subsystem  which  have  not  yet  been  covered  by  detailed  specifications  in  the 
corresponding  TSI  should  be  specified.  In  such  case,  the  bodies  responsible  for  the 
conformity  assessment  and  verification  procedures  should  be  those  already  notified 
under Article 20 of Directives 96/48/EC and 2001/16/EC. 

(cid:216) new 

(45)  The distinction between a high-speed rail system and a conventional rail system does 
not  warrant  two  separate  directives.  The  procedures  for  developing  technical 
specifications  for  interoperability  are  the  same  for  both  systems,  as  are  those  for  the 
certification  of  the  interoperability  constituents  and  the  subsystems.  The  essential 
requirements  are  practically  identical,  as  is  the  subdivision  of  the  system  into 
subsystems  for  which  technical  specifications  have  to  be  prepared.  Moreover,  since 
trains have to be able to move freely from the high-speed network to the conventional 
network,  the  technical  specifications  for  the  two  systems  overlap  to  a  large  extent; 
Work on developing the TSIs has shown that, for certain subsystems, a single TSI can 
serve  for  both  systems13.  It  is  therefore  appropriate  to  combine  Directives  96/48/EC 
and 2001/16/EC. 

(46)  Directive 2004/50/EC provided for the progressive extension of the scope of Directive 
2001/16/EC as new TSIs were adopted or existing ones revised. When this Directive 
comes into force, its scope will cover conventional and high-speed European networks 
as defined in the Community guidelines for trans-European transport networks14, and 
the  rolling  stock  likely  to  travel  on  those  networks.  The  scope  will  be  progressively 

13 

14 

See the conclusions of the Commission report to the Council and the European Parliament adopted on 
… 
TEN Guidelines 1996 … 

EN 

19 

   EN 

 
 
 
 
 
                                                 
extended  to  the  whole  network  and  all  rolling  stock,  provided  that  an  impact 
assessment shows the economic benefit of so doing. 

(cid:208) 2001/16/EC recital 6 (adapted) 

(47) 

In its White Paper entitled «A strategy for revitalising the Community's railways» in 
1996, the Commission announced a second measure in the conventional rail sector and 
then  ordered  a  study  on  the  integration  of  national  rail  systems,  the  results  of  which 
were published in May 1998 with the recommendation of the adoption of a Directive 
based  on  the  approach  taken  in  the  high-speed  sector.  This  study  also  recommended 
that, rather than tackling all the obstacles to interoperability head on, problems should 
be solved gradually according to an order of priority based on the cost-benefit ratio of 
each proposed measure. In this study the harmonisation of procedures and rules in use 
and the interconnection of information and communication systems were shown to be 
more  effective  than  measures,  for  example,  concerning  the  infrastructure  loading 
gauge. 

(cid:208) 2001/16/EC recital 7 (adapted) 

(48)  The  Commission  communication  on  «Integration  of  conventional  rail  systems» 
recommends  the  adoption  of  this  Directive  and  justifies  the  similarities  and  main 
differences  compared  with  Directive  96/48/EC.  The  main  differences  lie  in  the 
adaptation  of  the  geographical  scope,  in  the  extension  of  the  technical  scope  to  take 
account of the results of the above study and in the adoption of a gradual approach to 
eliminating  obstacles  to  the  interoperability  of  the  rail  system,  which  includes 
establishing an order of priorities and a timetable for drawing it up. 

(49) 

In  view  of  that  gradual  approach  and  of  the  time  consequently  required  for  the 
adoption of all the technical specifications for interoperability (TSIs), steps should be 
taken to avoid a situation where Member States adopt new national rules or undertake 
projects that increase the heterogeneity of the present system. 

(cid:208) 2001/16/EC recital 8  

(cid:208) 2001/16/EC recital 9 (adapted) 

(50)  The  adoption  of  a  gradual  approach  satisfies  the  special  needs  of  the  objective  of 
interoperability of the conventional rail system, which is characterised by old national 
infrastructure  and  stock  requiring  heavy  investment  for  adaptation  or  renewal,  and 
particular care should be taken not to penalise rail economically vis-à-vis other modes 
of transport. 

(51) 

In its Resolution of 10 March 1999 on the rail package the Parliament asked that the 
progressive  opening  up  of  the  rail  sector  go  hand-in-hand  with  the  fastest  and  most 
effective possible technical harmonisation measures. 

(cid:208) 2001/16/EC recital 10  

EN 

20 

   EN 

 
 
 
 
 
 
(cid:208) 2001/16/EC recital 11  

(52)  The Council meeting on 6 October 1999 asked the Commission to propose a strategy 
on  improving  the  interoperability  of  rail  transport  and  reducing  bottlenecks  with  a 
view  to  eliminating  technical,  administrative  and  economic  obstacles  to  the 
interoperability of networks without delay while guaranteeing a high level of safety as 
well as personnel training and qualifications. 

(cid:208) 2001/16/EC recital 12  

(53)  Pursuant to Council Directive 91/440/EEC of 29 July 1991 on the development of the 
Community's  railways15,  railway  companies  must  have  increased  access  to  Member 
States'  rail  networks,  which  in  turn  requires  the  interoperability  of  infrastructure, 
equipment,  rolling  stock  and  systems  of  management  and  operation,  including  those 
staff  qualifications  and  hygiene  and  safety  conditions  at  work  required  for  the 
operation and maintenance of the subsystems in question and for the implementation 
of  each  TSI.  However,  it  is  not  the  aim  of  this  Directive,  directly  or  indirectly,  to 
harmonise working conditions in the rail sector. 

(cid:208) 2001/16/EC recital 17 (adapted) 

(54) 

In view of the extent and complexity of the trans-European conventional rail system, it 
has  proved  necessary,  for  practical  reasons,  to  break  this  down  into  subsystems.  For 
each  of  these  subsystems  the  essential  requirements  must  be  specified  and  the 
technical  specifications  determined  for  the  whole  of  the  Community,  particularly  in 
respect of constituents and interfaces, in order to meet these essential requirements. 

(55) 

Implementation  of  the  provisions  on  the  interoperability  of  the  trans-European 
conventional rail system should not create unjustified barriers in cost-benefit terms to 
the  preservation  of  the  existing  rail  network  of  each  Member  State,  but  must 
endeavour to retain the objective of interoperability. 

(cid:208) 2001/16/EC recital 18 (adapted) 

(56)  The technical specifications for interoperability also have an impact on the conditions 
of use of rail transport by users, and it is therefore necessary to consult these users on 
aspects concerning them. 

(cid:208) 2001/16/EC recital 19  

15 

OJ L 237, 24.8.1991, p. 25. 

EN 

21 

   EN 

 
 
 
 
 
 
                                                 
(cid:208) 2001/16/EC recital 20  

(57)  Each  Member  State  concerned  should  be  allowed  not  to  apply  certain  technical 
specifications for interoperability in special cases, provided that there are procedures 
to  ensure  that  these  derogations  are  justified.  Article  155  of  the  Treaty  requires 
Community  activities  in  the  field  of  interoperability  to  take  account  of  the  potential 
economic viability of projects. 

(58)  The  drawing  up  of  TSIs  and  their application  to  the  conventional  rail  system  should 
not  impede  technological  innovation,  which  should  be  directed  towards  improving 
economic performance. 

(cid:208) 2001/16/EC recital 21 (adapted) 

(59)  Advantage  should  be  taken  of  the  interoperability  of  the  conventional  rail  system, 
particularly  in  the  case  of  freight,  to  bring  about  the  conditions  for  greater 
interoperability between modes of transport. 

(cid:208) 2001/16/EC recital 22 (adapted) 

(cid:208) 2001/16/EC recital 23  

(60)  To  comply  with  the  appropriate  provisions  on  procurement  procedures  in  the  rail 
sector and in particular Directive 93/38/EEC16, the contracting entities should include 
technical  specifications  in  the  general  documents  or  in  the  terms  and  conditions  for 
each contract. To this end it is necessary to build up a body of European specifications 
in order to serve as references for these technical specifications. 

(cid:208) 2001/16/EC recital 24  

(61)  An international system of standardisation capable of generating standards which are 
actually used by those involved in international trade and which meet the requirements 
of  Community  policy  would  be  in  the  Community's  interest.  The  European 
standardisation bodies must therefore continue their cooperation with the international 
standardisation bodies. 

(62)  The  contracting  entities  are  to  define  the  further  requirements  needed  to  complete 
European  specifications  or  other  standards.  These  specifications  should  meet  the 
essential requirements that have been harmonised at Community level and which the 
trans-European conventional rail system must satisfy. 

(cid:208) 2001/16/EC recital 25 (adapted) 

16 

Council  Directive  93/38/EEC  of  14  June  1993  coordinating  the  procurement  procedures  of  entities 
operating in the water, energy, transport and telecommunications sectors (OJ L 199, 9.8.1993, p. 84). 
Directive as last amended by Directive 98/4/EC (OJ L 101, 1.4.1998, p. 1). 

EN 

22 

   EN 

 
 
 
 
 
 
 
                                                 
(63)  The  procedures  governing  the  assessment  of  conformity  or  of  suitability  of  use  of 
constituents  should  be  based  on  the  use  of  the  modules  covered  by  Decision 
93/465/EEC17. As far as possible and in order to promote industrial development, it is 
appropriate to draw up the procedures involving a system of quality assurance. 

(cid:208) 2001/16/EC recital 26  

(cid:208) 2001/16/EC recital 27  

(64)  Conformity of constituents is mainly linked to their area of use in order to guarantee 
the  interoperability  of  the  system  and  not  only  to  their  free  movement  on  the 
Community market. The suitability for use of the most critical constituents as regards 
safety, availability or system economy should be assessed. It is therefore not necessary 
for a manufacturer to affix the CE marking to constituents that are now subject to the 
provisions  of  this  Directive.  On  the  basis  of  the  assessment  of  conformity  and/or 
suitability for use, the manufacturer's declaration of conformity should be sufficient. 

(65)  That does not affect the obligation on manufacturers to affix the CE marking to certain 
components  in  order  to  certify  their  compliance  with  other  Community  provisions 
relating to them. 

(cid:208) 2001/16/EC recital 28  

(66)  When a TSI comes into force, a number of interoperability constituents are already on 
the market. A transition period should be provided for so that these constituents can be 
integrated into a subsystem even if they do not strictly conform to the said TSI. 

(cid:216) new 

(cid:208) 2001/16/EC recital 29 (adapted) 
(cid:214) new 

(67)  The  subsystems  constituting  the  trans-European  conventional  rail  system  should  be 
subjected  to  a  verification  procedure.  This  verification  must  enable  the  authorities 
responsible for authorising their putting into service to be certain  that, at  the  design, 
construction  and  putting  into  service  stages,  the  result  is  in  line  with  the  regulations 
and technical and operational provisions in force. It must also enable manufacturers to 
be  able  to  count  upon  equality  of  treatment  whatever  the  country.  It  is  therefore 
necessary to lay down a module (cid:214) one or more modules  defining the principles and 
conditions applying to «EC» verification of subsystems. 

17 

Council  Decision  93/465/EEC  of  22  July  1993  concerning  the  modules  for  the  various  phases  of  the 
conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, 
which are intended to be used in the technical harmonisation directives (OJ L 220, 30.8.1993, p. 23). 

EN 

23 

   EN 

 
 
 
 
 
 
                                                 
(cid:216) new 

(68)  After  a  subsystem  is  placed  in  service,  care  should  be  taken  to  ensure  that  it  is 
operated  and  maintained  in  accordance  with  the  essential  requirements  relating  to  it. 
Under the Railway Safety Directive, responsibility for meeting these requirements lies, 
for  their  respective  subsystems,  with  the  infrastructure  manager  or  the  railway 
company.  Member  States  can  check  compliance  with  these  requirements  when 
granting safety certificates and safety approvals pursuant to Articles 10 and 11 of the 
Railway Safety Directive.  

(69)  As  far  as  rolling  stock  is  concerned,  it  is  not  economically  viable  to  require  an 
authorisation  for  placing  in  service  in  each  Member  State  for  each  vehicle.  It  is 
therefore necessary to simplify the procedure for placing in service. For wagons and 
passenger  carriages  placed  in  service  after  this  Directive  has  entered  into  force,  a 
single  authorisation  for  placing  in  service  issued  by  one  Member  State  of  the 
Community  should  suffice.  In  the  case  of  rolling  stock  placed  in  service  before  this 
Directive  enters  into  force  and  not  bearing  an  "EC"  declaration  of  verification,  it 
should be made clear that the Railway Safety Directive applies. In the case of rolling 
stock  bearing  an  "EC"  declaration  of  verification  as  provided  for  in  Article  18,  the 
only  criteria  which  a  safety  authority  may  check  with  a  view  to  issuing  an 
authorisation for placing in service should be comprehensively identified. In the case 
of  vehicle  series  produced  from  a  type,  Member  States  should  be  allowed  to  issue 
batch authorisations for placing in service. 

(cid:208) 2001/16/EC recital 30  

(70)  The "EC" verification procedure should be based on TSIs. These TSIs are subject to 
the provisions of Article 18 of Directive 93/38/EEC. The notified bodies responsible 
for examining the procedures for conformity assessment and suitability for the use of 
constituents,  together  with  the  procedure  for  the  assessment  of  subsystems  must,  in 
particular in the absence of any European specification, coordinate their decisions as 
closely as possible. 

(cid:208) 2001/16/EC recital 31 (adapted) 

(71)  These  TSIs  are  drawn  up  to  the  order  of  the  Commission  by  the  joint  body 
representing  the  infrastructure  managers,  the  railway  companies  and  the  industry. 
Representatives  of  non-member  countries,  in  particular  those  of  the  applicant 
countries,  may  from  the  outset  be  authorised  to  attend  meetings  of  the  joint 
representative body as observers. 

(cid:208) 2001/16/EC recital 32 (adapted) 
(cid:214) new 

(72)  Directive 91/440/EEC requires a separation of activities, in accounting terms, between 
transport  service  operation  and  railway  infrastructure  management.  This  being  the 
case, tThe specialised services provided by railway infrastructure managers designated 
as  notified  bodies  should  be  structured  in  such  a  way  as  to  meet  the  criteria  which 
must  apply  to  this  type  of  body  (cid:214)  in  all  sectors  of  the  new  approach  to  technical 

EN 

24 

   EN 

 
 
 
 
 
harmonisation and conformity verification, especially criteria relating to independence 
and  competence  .  Other  specialised  bodies  may  be  notified  where  these  meet  the 
same criteria. 

(cid:208) 2001/16/EC recital 33  
(cid:214) new 

(73)  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 
procedures for the exercise of implementing powers conferred on the Commission18. 

(cid:216) new 

(74) 

In  particular,  the  Commission  should  be  authorised  to  adopt  and  update  the  TSIs. 
Since  these  measures  are  general  in  scope  and  are  designed  to  supplement  this 
Directive  by  adding  new,  non-essential  elements,  they  should  be  adopted  in 
accordance with the regulatory procedure with scrutiny provided for in Article 5a of 
Decision 1999/468/EC. 

(cid:208) 2001/16/EC recital 34 (adapted) 

(75) 

Interoperability  within  the  trans-European  conventional  rail  system  is  Community-
wide in scale. No individual Member State is in a position to take the action needed in 
order to achieve this interoperability. In accordance with the principle of subsidiarity, 
the objectives of the proposed action cannot be sufficiently achieved by the Member 
States  and  can  therefore  by  reason  of  the  scale  or  effects  of  the  proposed  action  be 
better achieved by the Community. 

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

(cid:216) new 

18 

OJ L 184, 17.7.1999, p. 23. 

EN 

25 

   EN 

 
 
 
 
 
                                                 
HAVE ADOPTED THIS DIRECTIVE: 

(cid:208) 2001/16/EC 

CHAPTER ONE 

GENERAL PROVISIONS 

Article 1 

(cid:208) 2004/50/EC Art. 2(2)(a) 
(adapted) 
(cid:214) new 

1.  This  Directive  sets  out  to  establish  the  conditions  to  be  met  to  achieve  interoperability 
within the Community territory of the trans-European conventional rail system, as described 
in Annex I. These conditions concern the design, construction, placing in service, upgrading, 
renewal, operation and maintenance of the parts of this system placed in service after the date 
of entry into force of this Directive, as well as the professional qualifications and health and 
safety conditions of the staff who contribute to its operation and maintenance. (cid:214) They also 
concern  the  existing  rail  system  within  the  limits  specified  in  the  relevant  Articles,  in 
particular Articles 14(3) and 24 on registers.  

These  conditions  concern  the  design,  construction,  placing  in  service,  upgrading,  renewal, 
operation and maintenance of the parts of this system placed in service after 30 April 2004, as 
well  as  the  qualifications  and  health  and  safety  conditions  of  the  staff  who  contribute  to  its 
operation. 

(cid:208) 2004/50/EC Art. 1(1) 

2.  The  pursuit  of  this  objective  must  lead  to  the  definition  of  an  optimal  level  of  technical 
harmonisation and make it possible to: 

(cid:208) 2004/50/EC Art. 1(1) and Art. 
2(2)(b) 

(a)  facilitate,  improve  and  develop  international  rail  transport  services  within  the 
European Union and with third countries; 

(cid:208) 2001/16/EC 

(b) contribute to the gradual creation of the internal market in equipment and services 
for  the  construction,  operation,  renewal  and  upgrading  of  the  trans-European  high-
speed rail system; 

(cid:208) 2004/50/EC Art. 1(1) (adapted) 

EN 

26 

   EN 

 
 
 
 
 
 
 
 
 
(cid:208) 2001/16/EC (adapted) 

(b)  contribute  to  the  progressive  creation  of  the  internal  market  in  equipment  and 
services for the construction, renewal, upgrading and operation of the trans-European 
conventional rail system; 

(c) contribute to the interoperability of the trans-European conventional rail system. 

(cid:208) 2004/50/EC Art. 2(2)(c) 
(adapted) 
(cid:214) new 

3. The scope of this Directive shall be progressively extended to the whole conventional rail 
system,  including  track  access  to  terminals  and  main  port  facilities  serving  or  potentially 
serving more than one user, except for infrastructure and rolling stock reserved for a strictly 
local, historical or touristic use or infrastructure which is functionally isolated from the rest of 
the rail system, and without prejudice to the derogations to the application of TSIs as listed in 
Article 7. 

(cid:214) Outside the trans-European rail system,  Tthis Directive shall be applied to the parts of 
the network which are not yet covered by paragraph 1 only from the date of entry into force of 
the  corresponding  (cid:214)  relevant   TSIs  to  be  adopted  in  accordance  with  the  procedure 
described below and for the fields of application set by them. 

The Commission shall adopt, following the procedure set out in Article 21(2), (cid:214) (3),  by 
1 January 2006 a work programme (cid:214) one or more mandates  aiming at the development of 
new  TSIs  and/or  the  review  of  TSIs  already  adopted  with  a  view  to  covering  the  lines  and 
rolling stock not yet covered. 

This work programme (cid:214) The first mandate  shall indicate a first group of new TSIs and/or 
amendments to TSIs to be adopted by January 2009(cid:214) 2012 , without prejudice to Article 
5(5) as regards the possibility of providing for specific cases and without prejudice to Article 
7  allowing  for  derogations  in  particular  circumstances.  The  choice  of  the  subjects  to  be 
covered  by  the  TSIs  will  be  (cid:214)  This  first  mandate  shall  be  drawn  up  on  the  basis  of  a 
recommendation from the Agency with a view to determining the new TSIs to be developed 
and/or  the  existing  ones  to  be  amended    in  the  light  of  the  expected  cost-effectiveness  of 
each  proposed  measure  and  on  the  principle  of  proportionality  of  measures  taken  at 
Community level. To this end, appropriate consideration will be given to Annex I point 4 and 
the  necessary  balance  between,  on  one  hand,  the  objectives  of  uninterrupted  movement  of 
trains  and  of  technical  harmonisation,  and,  on  the  other  hand,  the  trans-European,  national, 
regional or local level of traffic considered. 

After the development of this first group of TSIs (cid:214) this first mandate,  the priorities for the 
development of new TSIs and/or the review of existing TSIs will be determined (cid:214) by means 
of mandates adopted  following the procedure set out in Article 21(2) (cid:214) (3)  . 

A Member State need not apply this paragraph in the case of projects at an advanced stage of 
development or subject to a contract in the course of performance when the relevant group of 
TSIs are published. 

EN 

27 

   EN 

 
 
 
 
 
(cid:208) 2001/16/EC and 96/48/EC 

For the purposes of this Directive: 

Article 2 

(cid:208) 2001/16/EC (adapted) 

(a) «trans-European conventional rail system» means the structure, as described in Annex I, 
points  1  and  2,  composed  of  lines  and  fixed  installations,  of  the  trans-European 
transport network, built or upgraded for conventional rail transport and combined rail 
transport ⌦ or  to  be  covered  at  high  speed ⌫  ,  plus  the  rolling  stock  designed  to 
travel on that infrastructure; 

(b)  "interoperability"  means  the  ability  of  the  trans-European  conventional  rail  system  to 
allow the safe and uninterrupted movement of trains which accomplish the required 
levels of performance for these lines. This ability rests on all the regulatory, technical 
and  operational  conditions  which  must  be  met  in  order  to  satisfy  the  essential 
requirements; 

(c)  «subsystems»  means  the  result  of  the  division  of  the  trans-European  conventional  rail 
system,  as  shown  in  Annex  II.  These  subsystems,  for  which  essential  requirements 
must be laid down, are structural and functional; 

(d)  «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 trans-European 
conventional  rail  system  depends  directly  or  indirectly.  The  concept  of  a 
«constituent» covers both tangible objects and intangible objects such as software; 

(e) «essential requirements» means all the conditions set out in Annex III which must be met 
the 

trans-European  conventional  rail  system, 

the  subsystems,  and 

the 

by 
interoperability constituents including interfaces; 

(f)  «European  specification»  means  a  common  technical specification, a European technical 
approval or a national standard transposing a European standard, as defined in points 
8 to 12 of Article 1 of Directive 93/38/EEC; 

(cid:208) 96/48/EC and 2001/16/EC  

(cid:208) 96/48/EC (adapted) 

(g)  «technical  specifications  for  interoperability»,  hereinafter  referred  to  as  «TSIs», 
the 
(g)technical  specifications  for 
specifications  by  which  each  subsystem  is  covered  in  order  to  meet  the  essential 
requirements  by  establishing  the  necessary  reciprocal  functional  relations  between 
the  subsystems  of  the  trans-European  high-speed  rail  system  and  by  ensuring  the 
latter's compatibility; 

interoperability  (hereinafter  TSIs)  means 

EN 

28 

   EN 

 
 
 
 
 
(g) «technical specifications for interoperability», hereinafter referred to as «TSIs», means the 
specifications by which each subsystem or part subsystem is covered in order to meet 
the  essential  requirements  and  ensure  the  interoperability  of  the  trans-European 
conventional rail system; 

(cid:208) 2001/16/EC (adapted) 

(i) «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» 
procedure for verification of the subsystems; 

(cid:208) 96/48/EC and 2001/16/EC  

(cid:208) 2001/16/EC (adapted) 
(cid:214) new 

(j)  «basic  parameters»  means  any  regulatory,  technical  or  operational  condition  which  is 
critical to interoperability and (cid:214) has to be specified in the TSIs  requires a decision 
in accordance with the procedure laid down in Article 21(2) before any development 
of draft TSIs by the joint representative body; 

(k)  «specific  case»  means  any  part  of  the  trans-European  conventional  rail  system  which 
needs  special  provisions  in  the  TSIs,  either  temporary  or  definitive,  because  of 
geographical,  topographical  or  urban  environment  constraints  or  those  affecting 
compatibility with the existing system. This may include in particular railway lines 
and networks isolated from the rest of the Community, the loading gauge, the track 
gauge  or  space  between  the  tracks  and  rolling  stock  strictly  intended  for  local, 
regional  or  historical  use,  as  well  as  rolling  stock  originating  from  or  destined  for 
third countries, as long as this stock does not cross the border between two Member 
States; 

(cid:208) 2004/50/EC Art. 1(2) and Art. 
2(3)(b) 

(l) «upgrading» means any major modification work on a subsystem or part subsystem which 

improves the overall performance of the subsystem; 

(m) «renewal» means any major substitution work on a subsystem or part subsystem which 

does not change the overall performance of the subsystem; 

(n) «existing rail system» means the structure composed of lines and fixed installations of the 
existing  rail  system  plus  the  rolling  stock  of  all  categories  and  origin  travelling  on 
that infrastructure; 

(cid:208) 2001/16/EC and 2004/50/EC 
Art. 1(2) 

EN 

29 

   EN 

 
 
 
 
 
 
(cid:208) 2004/50/EC Art. 1(2) and Art. 
2(3)(c) 

(o) «substitution in the framework of maintenance» means any replacement of components by 
parts  of  identical  function  and  performance  in  the  framework  of  preventive  or 
corrective maintenance; 

(p) «placing in service» means all the operations by which a subsystem is put into its design 

operating state. 

(cid:216) new 

(q)  "contracting  entity"  any  company,  whether  public  or  private,  which  orders  the  design 
and/or  construction  of  a  subsystem  under  certain  conditions  of  transparency  and 
competition. Depending on the subsystem to be built or modified, it can be a railway 
company, an infrastructure manager or a keeper, or the concession holder responsible 
for carrying out a project.  

(r)  "keeper"  means  the  person,  who  being  the  owner  or  having  the  right  to  dispose  of  it, 

exploits a vehicle economically in a permanent manner as a means of transport; 

(s)  "project  at  an  advanced  stage  of  development"  means  any  project  which  has  been  the 
subject  of  a  financing  decision  and  whose  design/construction  stage  has  reached  a 
point where a change in the technical specifications would be unacceptable. Such an 
impediment  may  be  contractual,  economic,  social  or  environmental  in  nature  and 
must be duly substantiated.  

(t)  "harmonised  standard"  means  any  European  standard  adopted  by  one  of  the  European 
standardisation bodies listed in Annex I to Directive 98/34/EC in connection with a 
mandate by the Commission drawn up in accordance with the procedure referred to 
in Article 6(3) of the said Directive, which, by itself or together with other standards, 
provides a solution as regards compliance with a legal provision.  

(cid:208) 2001/16/EC (adapted) 

Article 3 

1. This Directive applies to the provisions concerning, for each subsystem, the interoperability 
constituents, the interfaces and procedures as well as the conditions of overall compatibility of 
the trans-European conventional rail system required to achieve its interoperability. 

1.  This  Directive  applies  to  the  provisions  concerning,  for  each  subsystem,  the  parameters, 
interoperability  constituents,  interfaces  and  procedures  as  well  as  the  conditions  for  the 
overall  compatibility  of  the  trans-European  high-speed  rail  system  required  to  achieve  its 
interoperability. 

(cid:208) 96/48/EC (adapted) 

EN 

30 

   EN 

 
 
 
 
 
2.  The  provisions  of  this  Directive  shall  apply  without  prejudice  to  any  other  relevant 
Community  provisions.  However,  in  the  case  of  interoperability  constituents,  including 
interfaces, compliance with the essential requirements of this Directive may require the use of 
individual European specifications drawn up for that purpose. 

(cid:208) 2001/16/EC (adapted) 

1. The trans-European conventional rail system, subsystems and interoperability constituents 
including interfaces shall meet the relevant essential requirements. 

Article 4 

2.  The  further  technical  specifications  referred  to  in  Article  18(4)  of  Directive  93/38/EEC 
which are necessary to complete European specifications or other standards in use within the 
Community must not conflict with the essential requirements. 

(cid:208) 96/48/EC and 2001/16/EC 

CHAPTER II 

TECHNICAL SPECIFICATIONS FOR INTEROPERABILITY 

Article 5 

(cid:208) 2004/50/EC Art. 1(4)(a) and 
Art. 2(4)(a) (adapted) 

1. Each of the subsystems shall be covered by one TSI. Where necessary, a subsystem may be 
covered by several TSIs and one TSI may cover several subsystems. The decision to develop 
or  to  review  ⌦ revise ⌫  a  TSI  and  the  choice  of  its  technical  and  geographical  scope 
requires a mandate in accordance with Article 6(1). 

2. Subsystems shall comply with the TSIs; this compliance shall be permanently maintained 
while each subsystem is in use. 

(cid:208) 2001/16/EC 

(cid:208) 2001/16/EC and 2004/50/EC 
Art. 1(4)(b) 

3. To the extent necessary in order to achieve the objectives referred to in Article 1, each TSI 
shall: 

(a) indicate its intended scope (part of network or rolling stock referred to in Annex 
I: subsystem or part of subsystem referred to in Annex II); 

EN 

31 

   EN 

 
 
 
 
 
 
 
(b) lay down essential requirements for each subsystem concerned and its interfaces 
vis-à-vis other subsystems; 

(cid:208) 2001/16/EC (adapted) 

(c)  establish  the functional and technical specifications to  be met by the subsystem 
and  its  interfaces  vis-à-vis  other  subsystems.  If  need  be,  these  specifications  may 
vary according to the use of the subsystem, for example according to the categories 
of line, hub and/or rolling stock provided for in Annex I; 

(d) determine the interoperability constituents and interfaces which must be covered 
by  European  specifications,  including  European  standards,  which  are  necessary  to 
achieve interoperability within the trans-European conventional rail system; 

(cid:208) 2004/50/EC Art. 1(4)(b) and 
Art. 2(4)(b) 

(e) state, in each case under consideration, which procedures are to be used in order 
to assess the conformity or the suitability for use of the interoperability constituents, 
on  the  one  hand,  or  the  «EC»  verification  of  the  subsystems,  on  the  other  hand. 
These procedures shall be based on the modules defined in Decision 93/465/EEC; 

(cid:208) 2001/16/EC (adapted) 

(f)  indicate  the  strategy  for  implementing  the  TSIs.  In  particular,  it  is  necessary  to 
specify  the  stages  to  be  completed  in  order  to  make  a  gradual  transition  from  the 
existing situation to the final situation in which compliance with the TSIs shall be the 
norm; 

(g)  indicate,  for  the  staff  concerned,  the  professional  qualifications  and  health  and 
safety  conditions  at  work  required  for  the  operation  and  maintenance  of  the  above 
subsystem, as well as for the implementation of the TSIs. 

4. Each TSI shall be drawn up on the basis of an examination of an existing subsystem and 
indicate  a  target  subsystem  that  may  be  obtained  gradually  within  a  reasonable  time-scale. 
Accordingly, the gradual adoption of the TSIs and compliance therewith will help gradually 
to achieve the interoperability of the trans-European conventional rail system. 

5. The TSIs shall retain, in an appropriate manner, the compatibility of the existing rail system 
of each Member State. With this objective, provision may be made for specific cases for each 
set  of  TSIs,  with  regard  to  both  infrastructure  and  rolling  stock;  special  attention  must  be 
given to the loading gauge, the track gauge or space between the tracks and wagons from or 
going to third countries. For each specific case, the TSIs stipulate the implementing rules of 
the elements of the TSIs indicated in paragraphs 3(c) to (g). 

6. The TSIs shall not be an impediment to decisions by the Member States concerning the use 
of infrastructures for the movement of rolling stock not covered by the TSIs. 

EN 

32 

   EN 

 
 
 
 
 
 
 
 
 
 
(cid:208) 96/48/EC (adapted) 

4. The TSIs shall not be an impediment to decisions by the Member States concerning the use 
of new or upgraded infrastructures for running other trains. 

5.  Compliance  with  all  the  TSIs  shall  enable  a  compatible  trans-European  high-speed  rail 
system  to  be  set  up  that  will  preserve,  as  appropriate,  the  compatibility  of  each  Member 
State's existing rail network. 

(cid:208) 2004/50/EC Art. 1(4)(c) and 
Art. 2(4)(c) 
(cid:214) new 

7. TSIs may make an explicit, clearly identified reference to European or (cid:214) international  
standards or specifications where this is strictly necessary in order to achieve the objectives of 
this Directive. In such case, these European standards or specifications (or the relevant parts) 
shall  be  regarded  as  annexes  to  the  TSI  concerned  and  shall  become  mandatory  from  the 
moment  the  TSI  is  applicable.  In  the  absence  of  (cid:214)  such    European  standards  or 
specifications  and  pending  their  development,  reference  may  be  made  to  other  clearly 
identified  normative  documents;  in  such  case,  this  shall  concern  documents  that  are  easily 
accessible and in the public domain. 

(cid:208) 2004/50/EC Art. 1(5) and Art. 
2(5) (adapted) 
(cid:214) new 

Article 6 

1. Draft TSIs and subsequent amendments to TSIs shall be drafted (cid:214) by the Agency  under 
a mandate from the Commission in accordance with the procedure set out in Article 21(2) (cid:214) 
(3)    .  They  shall  be  drafted  under  the  responsibility  of  the  Agency,  in  accordance  with 
Articles 3  and  12  of  Regulation(EC)  No 881/2004  of  the  European  Parliament  and  of  the 
Council of 29 April 2004 establishing a European railway agency (Agency Regulation)19 and 
in cooperation with the working parties mentioned in those Articles. 

(cid:214) The measures amending the  non-essential  elements of this Directive by supplementing it 
with TSIs shall be adopted in accordance with the regulatory procedure with scrutiny referred 
to in Article 21(4).  

TSIs shall be adopted and reviewed in accordance with the (cid:214) same  procedure set out in 
Article  21(2).  They  shall  be  published  by  the  Commission  in  the  Official  Journal  of  the 
European Union. 

19 

OJ L 164, 30.4.2004, p. 1. 

EN 

33 

   EN 

 
 
 
 
                                                 
2. The Agency shall be responsible for preparing the review and updating of TSIs and making 
any recommendations to the Committee referred to in Article 21 (cid:214) Commission  in order to 
take account of developments in technology or social requirements. (cid:214) The Commission shall 
inform the Committee referred to in Article 21 about this  . 

3. Each draft TSI shall be drawn up in two stages. 

First of all, the Agency shall identify the basic parameters for the TSI as well as the interfaces 
with the other subsystems and any other specific cases that may be necessary. The most viable 
alternative  solutions  accompanied  by  technical  and  economic  justification  shall  be  put 
forward for each of these parameters and interfaces. A decision shall be taken in accordance 
with the procedure set out in Article 21(2); if necessary, specific cases shall be cited. 

The Agency shall then draw up the draft TSI on the basis of these basic parameters. Where 
appropriate,  the  Agency  shall  take  account  of  technical  progress,  of  standardisation  work 
already carried out, of working parties already in place and of acknowledged research work. 
An overall assessment of the estimated costs and benefits of the implementation of the TSIs 
shall be attached to the draft TSI; this assessment shall indicate the likely impact for all the 
operators and economic agents involved. 

4. The drafting, adoption and review of each TSI (including the basic parameters) shall take 
account of the estimated costs and benefits of all the technical solutions considered, together 
with the interfaces between them, so as to establish and implement the most viable solutions. 
The Member States shall participate in this assessment by providing the requisite data. 

5. The Committee referred to in Article 21 shall be kept regularly informed of the preparatory 
work  on  the  TSIs.  During  this  work  (cid:214)  the  Commission  may,  at  the  request  of    the 
Committee, may formulate any terms of reference or useful recommendations concerning the 
design  of  the  TSIs  and  the  cost-benefit  analysis.  In  particular,  the  Committee  (cid:214)  the 
Commission    may,  at  the  request  of  a  Member  State,  require  that  alternative  solutions  be 
examined and that the assessment of the cost and benefits of these alternative solutions be set 
out in the report annexed to the draft TSI. 

6. On the adoption of each TSI, the date of entry into force of that TSI shall be established in 
accordance with the procedure set out in Article 21(2) (cid:214) (4)  . Where different subsystems 
have to be placed in service simultaneously for reasons of technical compatibility, the dates of 
entry into force of the corresponding TSIs shall be the same. 

7. The drafting, adoption and review of the TSIs shall take account of the opinion of users, as 
regards the characteristics which have a direct impact on the conditions in which they use the 
subsystems. To that end the Agency shall consult associations and bodies representing users 
during  the  drafting  and  review  phases  of  the  TSIs.  They  shall  enclose  with  the  draft  TSI  a 
report on the results of this consultation. 

The list of associations and bodies to be consulted shall be finalised ⌦ drawn up ⌫ by the 
Committee  referred  to  in  Article  21  before  it  adopts  the  mandate  of  the  first  TSI  (cid:214)  the 
Commission, after consulting the Committee in accordance with the procedure referred to in 
Article 21(2),  and may be re-examined and updated at the request of a Member State or (cid:214) 
on the initiative of  the Commission. 

EN 

34 

   EN 

 
8. The drafting, adoption and review of the TSIs shall take account of the opinion of the social 
partners as regards the conditions referred to in Article 5(3)(g). 

To  this  end,  the  social  partners  shall  be  consulted  before  the  draft  TSI  is  submitted,  for 
adoption or review, to the Committee referred to in Article 21. 

The social partners shall be consulted in the context of the Sectoral Dialogue Committee set 
up in accordance with Commission Decision 98/500/EC20. The social partners shall issue their 
opinion within three months. 

(cid:216) new 

9.  When  each  TSI  is  adopted  and  revised,  a  decision  shall  be  taken  as  to  whether  technical 
annexes,  and  which  ones,  can  be  published  separately  by  the  Agency  and  what  special 
language  and  updating  rules  should  apply  in  view  of  the  evolving,  technological  nature  of 
those  annexes  (in  particular  in  the  case  of information  and  communication  technologies).  If 
such is the case, the language rules and the updating procedure are included in the measure 
adopting the TSI.  

(cid:208) 2001/16/EC and 2004/50/EC 
Art. 1(6) 
(cid:214) new 

Article 7 

1. A Member State need not apply one or more TSIs, including those relating to rolling stock, 
(cid:214) in accordance with this Article  in the following cases and circumstances: 

(cid:208) 2004/50/EC Art. 1(6) and Art. 
2(6) 

(a) for a proposed new line, for the renewal or upgrading of an existing line, or for 
any  element  referred  to  Article 1(1)  at  an  advanced  stage  of  development  or  the 
subject of a contract in course of performance when these TSIs are published; 

(cid:208) 2001/16/EC and 2004/50/EC 
Art. 1(6) 

(b) for any project concerning the renewal or upgrading of an existing line where the 
loading  gauge,  track  gauge,  space  between  the  tracks,  or  electrification  voltage  in 
these TSIs is not compatible with those of the existing line; 

(c) for a proposed new line or for the proposed renewal or upgrading of an existing 
line  in  the  territory  of  that  Member  State  when  its  rail  network  is  separated  or 
isolated by the sea from the rail network of the rest of the Community; 

20 

OJ L 225, 12.8.1998, p. 27. 

EN 

35 

   EN 

 
 
 
 
 
 
 
 
                                                 
(d)  for  any  proposed  renewal,  extension  or  upgrading  of  an  existing  line,  when  the 
application  of  these  TSIs  would  compromise  the  economic  viability  of  the  project 
and/or the compatibility of the rail system in the Member State; 

(e)  where,  following  an  accident  or  a  natural  disaster,  the  conditions  for  the  rapid 
restoration  of  the  network  do  not  economically  or  technically  allow  for  partial  or 
total application of the relevant TSIs; 

(f) for wagons from or going to third countries the track gauge of which is different from that 

of the main rail network of the Community. 

(cid:208) 2001/16/EC 

(cid:216) new 

2. In all cases, the Member State concerned shall notify to the Commission a file containing 
the information set out in Annex VIII. The Commission shall analyse the measures proposed 
by the Member State and shall inform the Committee referred to in Article 21. 

3.  In  cases  (c)  and  (e),  the  Commission  shall  check  that  the  file  is  in  conformity  and  shall 
inform  the  Member  States  of  the  results  of  its  analysis.  The  Member  State  may  apply  the 
alternative provisions without delay. 

(cid:208) 2001/16/EC (adapted) 
(cid:214) new 

In all cases the Member State concerned shall serve prior notice of its intended derogation to 
the Commission and shall forward to it a file setting out the TSIs or the parts of TSIs that it 
does  not  wish  to  be  applied  as  well  as  the  corresponding  specifications  that  it  does  wish  to 
apply.  (cid:214)  4.  In  cases  (cid:214) (a),   (b),  (d)  and  (f),  the  Commission  shall  take  a  decision 
(cid:214) decide,  in accordance with the procedure provided for in Article 21(2) (cid:214) (3)  , (cid:214) if 
the derogation request is accepted  ; where necessary, a recommendation shall be drawn up 
concerning the specifications to be applied. Nevertheless, in the case of (b) the Commission's 
decision shall not cover the loading gauge and the track gauge. (cid:214) The Commission shall give 
its  decision  within  six  months  of  the  presentation  of  the  request  supported  by  the  complete 
file.  Until  the  Commission  has  given  its  decision,  the  Member  State  may  not  apply  the 
derogation requested.   

(cid:208) 2004/50/EC Art. 1.6 (adapted) 

In all cases, the Member State concerned shall serve prior notice of its intended derogation to 
the Commission and shall forward to it a file setting out the TSIs or the parts of TSIs that it 
does  not  wish  to  be  applied  as  well  as  the  corresponding  specifications  that  it  does  wish  to 
apply.  The  Commission  shall  analyse  the  measures  envisaged  by  the  Member  State.  In 
cases (b) and (d), the Commission shall take a decision in accordance with the procedure set 
out  in  Article 21(2).  Where  necessary,  a  recommendation  shall  be  drawn  up  concerning  the 
specifications to be applied. Nevertheless, in the case of (b) the Commission's decision shall 
not cover the loading gauge and the track gauge. 

EN 

36 

   EN 

 
 
 
 
 
 
 
(cid:208) 96/48/EC and 2001/16/EC 

CHAPTER III 

INTEROPERABILITY CONSTITUENTS 

Article 8 

Member States shall take all necessary steps to ensure that interoperability constituents: 

(a) are placed on the market only if they enable interoperability to be achieved within 
the  trans-European  conventional  rail  system  while  at  the  same  time  meeting  the 
essential requirements; 

(cid:208) 2001/16/EC (adapted) 

(b) are used in their area of use as intended and are suitably installed and maintained. 

(cid:208) 96/48/EC and 2001/16/EC 

These provisions shall not obstruct the placing on the market of these constituents for other 
applications. 

(cid:208) 2001/16/EC 

These  provisions  do  not  exclude  the  placing  on  the  market  of  these  constituents  for  other 
purposes, nor their use for conventional railway lines. 

(cid:208) 96/48/EC (adapted) 

(cid:208) 2001/16/EC (adapted) 

Article 9 

Member States may not, in their territory and on grounds concerning this Directive, prohibit, 
restrict or hinder the placing on the market of interoperability constituents for use in the trans-
European conventional rail system where they comply with this Directive. In particular, they 
may not require checks which have already been carried out as part of the procedure of «EC» 
declaration of conformity or suitability for use, the components of which are set out in Annex 
IV. 

In particular, they may not require checks which have already been carried out as part of the 
procedure leading to the EC declaration of conformity or suitability for use. 

(cid:208) 2004/50/EC Art. 1(7) 

EN 

37 

   EN 

 
 
 
 
 
 
 
 
 
 
(cid:208) 2001/16/EC 

Article 10 

1.  Member  States  shall  consider  as  complying  with  the  essential  requirements  of  this 
Directive  applying  to  them  those  interoperability  constituents  which  bear  the  «EC» 
declaration of conformity or suitability for use. 

2. All interoperability constituents shall be subject to the procedure for assessing conformity 
and  suitability  for  the  use  indicated  in  the  respective  TSI  and  shall  be  accompanied  by  the 
corresponding certificate. 

(cid:208) 2004/50/EC Art. 2.7(a) 

(cid:208) 2004/50/EC Art. 1.4(b) and Art. 
2. 8(b) 

3.  Member  States  shall  consider  that  an  interoperability  constituent  meets  the  essential 
requirements  if  it  complies  with  the  conditions  laid  down  by  the  corresponding  TSI  or  the 
corresponding European specifications developed to comply with these conditions. 

6.  Where a European specification is not yet available at the time of adoption of a TSI and 
compliance  with  this  specification  is  an  essential  precondition  to  guarantee  interoperability, 
the TSI may refer to the most advanced version available of the draft European specification 
that has to be complied with or that incorporates all or part of that draft. 

(cid:208) 2001/16/EC (new) 

TSIs  shall  provide  for  a  period  of  transition  for  interoperability  constituents  which  have 
already  been  placed  on  the  market  when  the  TSIs  enter  into  force.  So  that  they  can  be 
integrated into a subsystem, such constituents must satisfy the requirements of Article 8. 

(cid:216) new 

(cid:208) 2004/50/EC Art. 2(8) 
(cid:214) new 

Article 11 

Where  it  appears  to  a  Member  State  or  the  Commission  that  European  specifications  used 
directly  or  indirectly  to  achieve  the  objectives  of  this  Directive  do  not  meet  the  essential 
requirements,  (cid:214)  the  Committee  referred  to  in  Article  21  shall  be  informed  and  the 
Commission shall adopt the most appropriate measure, i.e.  

EN 

38 

   EN 

 
 
 
 
 
 
 
(a) 

partial or total withdrawal of the specifications concerned from the publications 
containing them, or their amendment, may be decided upon in accordance with 
the  procedure  set  out  in  Article  21(2)  after  consultation,  where  European 
standards are involved, of the Committee set up under Directive 98/34/EC, or 

(b)  (cid:214) review of the TSI in accordance with Article 6(1)  . 

(cid:208) 2001/16/EC 

Article 12 

1.  Where  a  Member  State  finds  that  an  interoperability  constituent  covered  by  the  «EC» 
declaration  of  conformity  or  suitability  for  use  and  placed  on  the  market  is  unlikely,  when 
used as intended, to meet the essential requirements, it shall take all necessary steps to restrict 
its  field  of  application,  prohibit  its  use  or  withdraw  it  from  the  market.  The  Member  States 
shall  forthwith  inform  the  Commission  of  the  measures  taken  and  give  the  reasons  for  its 
decision, stating in particular whether failure to conform is due to: 

(cid:208) 96/48/EC and 2001/16/EC 

(a) failure to meet the essential requirements; 

(b)  incorrect  application  of  European  specifications  where  application  of  such 
specifications is relied upon; 

(c) inadequacy of European specifications. 

2.  The  Commission  shall  consult  the  parties  concerned  as  quickly  as  possible.  Where, 
following  that  consultation, the  Commission establishes that the measure  is  justified  it  shall 
forthwith inform the Member State that has taken the initiative as well as the other Member 
States thereof. Where, after that consultation, the Commission establishes that the measure is 
unjustified  it  shall  forthwith  inform  the  Member  State  that  has  taken  the  initiative  and  the 
manufacturer  or  his  authorised  representative  established  within  the  Community  thereof. 
Where  the  decision  referred  to  in  paragraph  1  is  justified  by  the  existence  of  a  gap  in 
European specifications, the procedure defined in Article 11 shall apply. 

3. Where an interoperability constituent bearing the «EC» declaration of conformity fails to 
comply,  the  competent  Member  State  shall  take  appropriate  measures  against  whomsoever 
has drawn up the declaration and shall inform the Commission and the other Member States 
thereof. 

4. The Commission shall ensure that the Member States are kept informed of the course and 
results of that procedure. 

EN 

39 

   EN 

 
 
 
 
 
 
(cid:208) 2001/16/EC 

Article 13 

1.  In  order  to  establish  the  «EC»  declaration  of  conformity  or  suitability  for  use  of  an 
interoperability  constituent,  the  manufacturer  or  his  authorised  representative  established  in 
the Community shall apply the provisions laid down by the relevant TSIs. 

2.  Where  so  required  by  the  TSIs,  the  assessment  of  conformity  or  suitability  for  use  of  an 
interoperability  constituent  shall  be  appraised  by  the  notified  body  with  which  the 
manufacturer  or  his  authorized  representative  established  within  the  Community  has  lodged 
the application. 

(cid:208) 96/48/EC (adapted) 

2. Assessment of the conformity or suitability for use of an interoperability constituent shall 
be  carried  out  by  the  notified  body  with  which  the  manufacturer  or  his  authorised 
representative established in the Community has lodged the application. 

(cid:208) 2001/16/EC 

(cid:208) 96/48/EC and 2001/16/EC 

3. Where interoperability constituents are the subject of other Community directives covering 
other  aspects,  the  «EC»  declaration  of  conformity  or  suitability  for  use  shall,  in  such 
instances, state that the interoperability constituents also meet the requirements of those other 
directives. 

4.  Where  neither  the  manufacturer  nor  his  authorised  representative  established  in  the 
Community  has  met  the  obligations  arising  out  of  paragraphs  1,  2  and  3,  those  obligations 
shall be incumbent on any person who places interoperability constituents on the market. The 
same  obligations  shall  apply  to  whomsoever  assembles interoperability  constituents or parts 
of  interoperability  constituents  having  diverse  origins  or  manufactures  interoperability 
constituents for his own use, for the purposes of this Directive. 

5. Without prejudice to the provisions of Article 12: 

(cid:208) 2001/16/EC (adapted) 
(cid:214) new 

(a)  in  each  instance  where  the  Member  State  finds  that  the  «EC»  declaration  of  conformity 
has  been  drawn  up  improperly,  the  manufacturer  or  his  authorised  representative 
established  in  the  Community  shall  be  required,  (cid:214)  if  necessary,    to  restore  the 
interoperability constituent to a state of conformity and to terminate the infringement 
under the conditions laid down by that Member State; 

EN 

40 

   EN 

 
 
 
 
 
 
(b) where non-conformity persists, the Member State shall take all appropriate steps 
to restrict or prohibit the placing on the market of the interoperability constituent at 
issue,  or  to  ensure  that  it  is  withdrawn  from  the  market  in  accordance  with  the 
procedures provided for in Article 12. 

CHAPTER IV 

SUBSYSTEMS 

Article 14 

1. Each Member State shall authorise the putting into service of those structural subsystems 
constituting the trans-European conventional rail system which are located or operated in its 
territory. 

To  this  end,  Member  States  shall  take  all  appropriate  steps  to  ensure  that  these  subsystems 
may be put into service only if they are designed, constructed and installed in such a way as to 
meet  the  essential  requirements  concerning  them  when  integrated  into  the  trans-European 
conventional rail system. In particular, they shall check the compatibility of these subsystems 
with the system into which they are being integrated. 

2.  Each  Member  State  shall  check  when  they  are  put  into  service  and  at  regular  intervals 
thereafter, that (cid:214) the TSI rules devised to ensure that  these subsystems are operated and 
maintained in accordance with the essential requirements concerning them (cid:214) , are complied 
with. After these subsystems have been placed in service, the check will be carried out in the 
context  of  granting  safety  certificates  and  safety  approvals  under  Articles  10  and  11  of  the 
Railway Safety Directive21  . 

To that end, the assessment and verification procedures laid down in the respective structural 
and functional TSIs shall be used. 

(cid:208) 2004/50/EC Art. 2(9)(a) 

(cid:208) 2004/50/EC Art. 2.9(b) 
(adapted) 
(cid:214) new 

3. In the event of renewal or upgrading, the infrastructure manager or the railway undertaking 
(cid:214)  the  contracting  entity    shall  send  the  Member  State  concerned  a  file  describing  the 
project. The Member State shall examine this file and, taking account of the implementation 
strategy indicated in the applicable TSI, shall decide whether the size of the works means that 
a new authorisation for placing in service within the meaning of this Directive is needed. 

21 

Directive 2004/49/EC … 

EN 

41 

   EN 

 
 
 
 
                                                 
Such  new  authorisation  for  placing  in  service  shall  be  required  whenever  the  overall  safety 
level  of  the  subsystem  concerned  may  be  affected  by  the  works  envisaged.  If  a  new 
authorisation  is  needed,  the  Member  State  shall  decide  to  what  extent  the  TSIs  need  to  be 
applied to the project. The Member State shall notify its decision to the Commission and the 
other Member States. (cid:214) and shall state:  

–  the reason why the TSI(s) is/are not fully applied; 

–  the technical characteristics applying instead of the TSI; 

(cid:216) new 

–  The  bodies  responsible  for  applying,  in  the  case  of  those  characteristics,  the  verification 

procedure referred to in Article 18. 

The Commission shall communicate this information to the Agency, which shall publish it. 

Where the Member State decides that an authorisation for placing in service is not necessary 
or  where  a  TSI  is  only  partially  applied  pursuant  to  this  paragraph,  the  application  for  or 
notification of a derogation within the meaning of Article 7 shall be optional. 

(cid:208) 2004/50/EC Art. 1, pt 10 and 
Art. 2, pt 9 c 
(cid:214) new 

4.  Where  Member  States  authorise  the  placing  in  service  of  rolling  stock,  they  shall  be 
responsible for ensuring that an alphanumeric identification code is assigned to each vehicle. 
This code must be marked on each vehicle and be entered in a national vehicle register that 
meets the following criteria: 

(a) the register shall comply with the common specifications defined in paragraph 5; 

(b)  the  register  shall  be  kept  and  updated  by  a  body  independent  of  any  railway 
undertaking; 

in  Articles  16 

and  21  of  Directive 2004/49/EC  of 

(c) the register shall be accessible to the safety authorities and investigating bodies 
designated 
the 
European Parliament  and  of  the  Council  of  29 April  2004  on  safety  on  the 
Community's railways (Railway Safety Directive)22; it shall also be made accessible, 
in response to any legitimate request, to the regulatory bodies designated in Article 
30  of  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  and  safety  certification23,  to  the 
Agency, to the railway companies and to the infrastructure managers. 

22 
23 

OJ L 164, 30.4.2004, p. 44. 
OJ  L 75,  15.3.2001,  p. 29.  Directive  as  amended  by  Directive 2002/844/EC  (OJ  L 289,  26.10.2002, 
p. 30). 

EN 

42 

   EN 

 
 
 
 
 
 
                                                 
In case of rolling stock placed in service for the first time in a third country, Member States 
may accept vehicles clearly identified according to a different coding system. However, once 
a Member State has authorised the placing in service of such vehicles on its territory, it must 
be  possible  to  retrieve  the  corresponding  data,  listed  below  in  paragraph 5(c),  (d)  and  (e), 
through the register. 

5.  The  common  specifications  for  the  register  shall  be  adopted  in  accordance  with  the 
procedure set out in Article 21(2) (cid:214) (3)  , on the basis of the draft specifications prepared 
by the Agency. These draft specifications shall include: content, data format, functional and 
technical architecture, operating mode, and rules for data input and consultation. The register 
shall contain at least the following information: 

(a) references to the EC declaration of verification and the issuing body; 

(b) references to the register of rolling stock mentioned in Article 24; 

(c) identification of the owner of the vehicle or the lessee (cid:214) or the keeper  ; 

(d) any restrictions on how the vehicle may be used; 

(e)  safety-critical  data  relating  to  the  maintenance  schedule  of  the  vehicle  (cid:214)  entity 
responsible  for  maintenance.  If  this  information  is  not  available  when  placing  in 
service is authorised, it can be added later but before the vehicle is used by a railway 
company.  

(cid:216) new 

6. For wagons and passenger carriages placed in service after this Directive has entered into 
force,  the  TSI  makes  clear  whether  a  single  authorisation  for  putting  into  service 
issued  by  one  Member  State  of  the  Community  is  sufficient  and  under  what 
conditions.  

7. In the case of rolling stock placed in service before this Directive enters into force and not 
bearing  an  "EC"  declaration  of  verification  as  provided  for  by  Article  18  of  this 
Directive, the Railway Safety Directive applies. In particular: 

–  If the safety authority of a Member State so requires, an additional authorisation 
to  place  rolling  stock  in  service  must  be  obtained  in  accordance  with  the 
provisions of Article 14 of the Railway Safety Directive;  

–  Otherwise, the safety certificate granted to the railway company under Article 10 
of the Railway Safety Directive shall serve as an authorisation for placing rolling 
stock in use in service. 

8. In the case of rolling stock bearing an "EC" declaration of verification as provided for in 
Article  18,  the  criteria  which  a  safety  authority  checks  with  a  view  to  issuing  an 
authorisation for placing in service may concern only: 

–  technical  compatibility  between 

that  rolling  stock  and 

the 

infrastructure 

concerned; 

–  the rules applicable to the open points referred to in Article 17(2); 

EN 

43 

   EN 

 
 
 
 
 
 
 
 
–  the rules applicable to the specific cases duly identified in the relevant TSIs; 

–  The derogations duly notified in accordance with Article 7 of this Directive.  

9.  Without  prejudice  to  the  procedure  mentioned  in  Article  18,  Member  States  may  issue 

authorisations for placing in service for a rolling-stock series. 

(cid:208) 2001/16/EC (adapted) 

Article 15 

Without prejudice to the provisions of Article 19, Member States may not, in their territory 
and on grounds concerning this Directive, prohibit, restrict or hinder the construction, putting 
into  service  and  operating  of  structural  subsystems  constituting  the  trans-European 
conventional  rail  system  which  meet  the  essential  requirements.  In  particular,  they  may  not 
require  checks  which  have  already  been  carried  out  as  part  of  the  procedure  leading  to  the 
«EC» declaration of verification, the components of which are set out in Annex V. 

In particular, they may not require checks which have already been carried out as part of the 
procedure leading to the «EC» declaration of verification. 

(cid:208) 2004/50/EC Art. 1(11) 

(cid:208) 2001/16/EC (adapted) 

Article 16 

1. Member States shall consider as being interoperable and meeting the essential requirements 
concerning  them,  those  structural  subsystems  constituting  the  trans-European  conventional 
rail system which are covered by the «EC» declaration of verification. 

2.  Verification  of  the  interoperability,  in  accordance  with  the  essential  requirements,  of  a 
structural  subsystem  constituting  the  trans-European  conventional  rail  system  shall  be 
established by reference to TSIs where they exist. 

(cid:208) 2004/50/EC Art. 1(12) and Art. 
2(10) 
(cid:214) new 

3.  In  the  absence  of  TSIs,  and  including  cases  when  a  derogation  has  been  notified  under 
Article 7, (cid:214) or when a specific case requires the application of technical rules not included in 
the  TSI  concerned,    Member  States  shall  send  the  other  Member  States  and  the 
Commission,  for  each  subsystem,  a  list  of  the  technical  rules  in  use  for  implementing  the 
essential requirements. 

EN 

44 

   EN 

 
 
 
 
 
This shall be notified (cid:214) , depending on the circumstances,  either by 30 April 2005 (cid:214) at the 
latest two years after the entry into force of this Directive  and thereafter each time the list 
of technical rules is changed (cid:214) , or after the derogation has been notified, or after publication 
of  the  TSI  concerned    .  On  that  occasion,  Member  States  shall  also  designate  the  bodies 
responsible  for  carrying  out,  in  the  case  of  these  technical  regulations,  the  verification 
procedure referred to in Article 18. 

The Commission shall communicate this information to the Agency, which shall publish it. 

(cid:216) new 

(cid:208) 96/48/EC and 2001/16/EC 
(adapted) 
(cid:214) new 

Article 17 

1.  If  it  emerges  that  the  TSIs  do  not  fully  meet  the  essential  requirements,  the  Committee 
referred to in Article 21 may be consulted at the request of a Member State or on the initiative 
of the Commission (cid:214) , in connection with the review procedure  . 

(cid:208) 2004/50/EC Art. 1(13) and Art. 
2(11) 

In such a case, the TSIs shall be reviewed in accordance with Article 6(2). 

2. If certain technical aspects corresponding to the essential requirements cannot be explicitly 
covered in a TSI, they shall be clearly identified in an Annex to the TSI. Article 16(3) shall 
apply to these aspects. 

(cid:216) new 

3. Where a Member State or the Commission considers that it is urgent to modify a TSI, the 
Agency  shall  be  requested  to  provide  a  Technical  Opinion.  The  Commission  shall  decide, 
having  consulted  the  Committee  under  the  procedure  referred  to  in  Article  21(2),  if  the 
Technical opinion may be used pending the review of the TSI; if such is the case, the Agency 
shall publish the Technical Opinion. 

(cid:208) 2001/16/EC 
(cid:214) new 

Article 18 

1.  In  order  to  establish  the  "EC"  declaration  of  verification,  the  procurement  entity  or  its 
official representative (cid:214) the applicant  shall invite the notified body that it has selected for 
that  purpose  to  apply  the  "EC"  verification  procedure  referred  to  in  Annex  VI.  (cid:214)  The 
applicant may be  the  contracting entity or  the constructor, or their authorised representative 
within the Community.  

EN 

45 

   EN 

 
 
 
 
 
 
2.  The  task  of  the  notified  body  responsible  for  the  «EC»  verification  of  a  subsystem  shall 
begin at the design stage and cover the entire manufacturing period through to the acceptance 
stage before the subsystem is put into service. It shall also cover verification of the interfaces 
of  the  subsystem  in  question  with  the  system  into  which  it  is  incorporated,  based  on  the 
information available in the relevant TSI and in the registers provided for in Article 24. 

3.  The  notified  body  shall  be  responsible  for  compiling  the  technical  file  that  has  to 
accompany  the  «EC»  declaration  of  verification.  This  technical  file  must  contain  all  the 
necessary documents relating to the characteristics of the subsystem and, where appropriate, 
all  the  documents  certifying  conformity  of  the  interoperability  constituents.  It  should  also 
contain  all  the  elements  relating  to  the  conditions  and  limits  of  use  and  to  the  instructions 
concerning servicing, constant or routine monitoring, adjustment and maintenance. 

(cid:216) new 

4. The notified body may issue intermediate verification certificates to cover certain stages of 
the production cycle or certain parts of the subsystem. In such a case, the procedure set out in 
Annex VI shall apply. 

5.  If  chapter  6  of  the  corresponding  TSI  allows,  the  notified  body  may  issue  verification 
certificates for a rolling-stock series.  

(cid:208) 96/48/EC and 2001/16/EC 

Article 19 

1. Where a Member State finds that a structural subsystem covered by the «EC» declaration 
of verification accompanied by the technical file does not fully comply with this Directive and 
in particular does not meet the essential requirements, it may request that additional checks be 
carried out. 

2.  The  Member  State  making  the  request  shall  forthwith  inform  the  Commission  of  any 
additional checks requested and set out the substantiating reasons therefor. The Commission 
shall  without  delay  initiate  the  procedure  provided  for  in  Article  21  (2).  The  Commission 
shall consult the interested parties. 

3. The Member State making the request shall state whether the failure to conform is due to:  

(cid:216) new 

(c) 

non-compliance  with  the  essential  requirements  or  a  TSI  or  incorrect 
application of a TSI. In such a case, the Commission shall immediately inform 
the  Member  State  where  the  person  who  drew  up  the  "EC"  declaration  of 
verification in error resides and shall ask it to take the appropriate measures;  

(d) 

inadequacy of a TSI. In such a case, the procedure for reviewing the TSI shall 
be started pursuant to Article 6(1). 

EN 

46 

   EN 

 
 
 
 
(cid:208) 2001/16/EC (adapted) 

CHAPTER V 

NOTIFIED BODIES 

Article 20 

1.  Member  States  shall  notify  to  the  Commission  and  the  other  Member  States  the  bodies 
responsible for carrying out the procedure for the assessment of conformity or suitability for 
use referred to in Article 13 and the verification procedure referred to in Article 18, indicating 
each  body's  area  of  responsibility,  and  the  identification  numbers  obtained  in  advance  from 
the  Commission.  The  Commission  shall  publish  in  the  Official  Journal  of  the  European 
Communities  ⌦ Union ⌫  the  list  of  bodies,  their  identification  numbers  and  areas  of 
responsibility, and shall keep the list updated. 

2. Member States shall apply the criteria provided for in Annex VII for the assessment of the 
bodies  to  be  notified.  Bodies  meeting  the  assessment  criteria  provided  for  in  the  relevant 
European standards shall be deemed to meet the said criteria. 

(cid:208) 96/48/EC and 2001/16/EC 
(cid:214) new 

3. A Member State shall withdraw approval from a body which no longer meets the criteria 
referred  to  in  Annex  VII.  It  shall  forthwith  inform  the  Commission  and  the  other  Member 
States thereof. 

4.  Should  a  Member  State  or  the  Commission  consider  that  a  body  notified  by  another 
Member  State  does  not  meet  the  relevant  criteria,  the  matter  shall  be  referred  to  the 
Committee provided for in Article 21, which shall deliver its opinion within three months (cid:214) 
the  Commission  shall  consult  the  parties  concerned.    In  the  light  of  the  opinion  of  the 
Committee, (cid:214) After consulting the Committee in accordance with the procedure referred to in 
Article 21(2),  the Commission shall inform the Member State in question of any changes 
that are necessary for the notified body to retain the status conferred upon it. 

(cid:208) 2004/50/EC Art. 1(15) and Art. 
2(12) 

5. The Commission shall set up a notified bodies coordination group (hereinafter referred to 
as  the  coordination  group)  which  shall  discuss  any  matter  relating  to  the  application  of  the 
procedures for assessing conformity or suitability for the use referred to in Article 13 and the 
verification procedure referred to in Article 18, or to application of the relevant TSIs. Member 
States' representatives may take part in the work of the coordination group as observers. 

The Commission and the observers shall inform the committee referred to in Article 21 of the 
work  carried  out  in  the  framework  of  this  coordination  group.  The  Commission,  when 
appropriate, will propose the measures needed to remedy the problems. 

EN 

47 

   EN 

 
 
 
 
Where necessary, coordination of the notified bodies shall be implemented in accordance with 
Article 21(5). 

(cid:208) 2001/16/EC 

CHAPTER VI 

COMMITTEE AND WORK PROGRAMME 

Article 21 

1. The Commission shall be assisted by the Committee established by Article 21 of Directive 
96/48/EC (hereinafter referred to as "the Committee"). 

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

(cid:216) new 

(cid:208) 2001/16/EC and 2004/50/EC 
Art. 1(16) 

23.  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. 

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

4. 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:216) new 

3. The Committee shall adopt its rules of procedure. 

(cid:208) 2001/16/EC and 2004/50/EC 
Art. 1, pt 16 

(cid:208) 2004/50/EC Art. 2, pt 13  

4  5.  Should  it  prove  necessary,  the  Committee  may  set  up  working  parties  to  assist  it  in 
carrying out its tasks, in particular with a view to coordinating the notified bodies. 

EN 

48 

   EN 

 
 
 
 
 
 
(cid:208) 2004/50/EC Art. 2(14) 
(cid:214) new 

Article 21a 

6. The Commission may submit to the Committee any matter relating to the implementation 
of this Directive. If necessary, the Commission shall adopt an implementing recommendation 
in accordance with the procedure set out in Article 21(2) (cid:214) (2)  . 

(cid:208) 2004/50/EC Art. 1, pt 17 
(adapted) 

1.  The  Committee  may  discuss  any  matter  relating  to  the  interoperability  of  the  trans-
European high-speed rail system, including questions relating to interoperability between this 
system and the rail system of third countries. 

2. The Committee may discuss any matter relating to the implementation of this Directive. If 
necessary, the Commission shall adopt an implementing recommendation in accordance with 
the procedure set out in Article 21(2). 

Article 21b 

1. The Commission may decide, on its own initiative or at the request of a Member State, in 
accordance with the procedure set out in Article 21(2), to mandate the drafting of a TSI for an 
additional subject, insofar as it concerns a subsystem mentioned in Annex II. 

2. In accordance with the procedure set out in Article 21(2), the Committee shall, on the basis 
of a proposal by the Commission, adopt a work programme conforming to the objectives of 
this  Directive  and  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 system24. 

(cid:208) 2004/50/EC Art. 1(17) and Art. 
2(14)  
(cid:214) new 

Article 21b 

7.  Annexes  II  to  VI  may  be  amended  in  accordance  with  the  procedure  set  out  in 
Article 21(2). (cid:214) The measures amending the non-essential elements of this Directive set out 
in  Annexes  II  to  VII  shall  be  adopted  in  accordance  with  the  regulatory  procedure  with 
scrutiny referred to in paragraph 4 of this Article.  

24 

OJ L 110, 20.4.2001, p. 1. 

EN 

49 

   EN 

 
 
 
 
                                                 
(cid:208) 2001/16/EC (adapted) 
(cid:214) new 

Article 22 

Once  this  Directive  enters  into  force,  the  Committee  may  discuss  any  matter  relating  to  the 
interoperability of the trans-European conventional rail system, including questions relating to 
interoperability between the (cid:214) Community  trans-European rail system and the rail system 
of third countries. 

(cid:208) 2004/50/EC Art. 2, pt 15 
(adapted) 
(cid:214) new 

Article 23 

1. The order of priority for the adoption of the TSIs shall be as follows, without prejudice to 
the order of adoption of the mandates provided for in Article 6(1): 

(a)  the  first  group  of  TSIs  shall  cover  control/command  and  signalling;  telematic 
applications  for  freight  services;  traffic  operation  and  management  (including  staff 
qualifications for cross-border services respecting the criteria defined in Annexes II 
and III);  freight  wagons;  noise  problems  deriving  from  rolling  stock  and 
infrastructure.  As  regards  rolling  stock,  that  intended  for  international  use  shall  be 
developed first; 

(b) the following aspects shall also be discussed in the light of the resources of the 
Commission  and  the  Agency:  telematic  applications  for  passenger  services, 
maintenance, with particular regard to safety, passenger carriages, traction units and 
locomotives,  infrastructure,  energy  and  air  pollution.  As  regards  rolling  stock,  that 
intended for international use shall be developed first; 

(c) at the request of the Commission, a Member State or the Agency, the Committee 
may decide, in accordance with the procedure set out in Article 21(2), to draw up a 
TSI  for  an  additional  subject  in  so  far  as  it  concerns  a  subsystem  mentioned  in 
Annex II. 

21. The Commission, in accordance with the procedure set out in Article 21(2), shall draw up 
a work programme (cid:214) taking account of the extension of the scope, provided for in Article1 
(3), of the review of the TSIs provided for in Article 6(2)  observing the order of priority 
referred to in paragraph 1 and that of the other tasks entrusted to it by this Directive. 

The TSIs mentioned in the first work programme referred to in paragraph 1(a) shall be drawn 
up not later than 20 April 2004. 

EN 

50 

   EN 

 
 
 
 
 
 
32. The work programme shall consist of the following stages: 

(a) development on the basis of a draft established by the Agency of a representative 
architecture of the conventional rail system, based on the list of subsystems (Annex 
II),  to  guarantee  consistency  between  TSIs;  this  architecture  must  include  in 
particular  the  various  constituents  of  this  system  and  their  interfaces  and  act  as  a 
reference framework for defining the areas of use of each TSI; 

(b) adoption of a model structure for developing TSIs; 

(c) adoption of a method of cost-benefit analysis of the solutions set out in the TSIs; 

(d) adoption of the mandates needed to draw up the TSIs; 

(e) adoption (cid:214) identification  of the basic parameters for each TSI; 

(f) approval of draft standardisation programmes; 

(g)  management  of  the  transition  period  between  the  date  of  entry  into  force  of 
Directive 2004/50/EC  of  the  European  Parliament  and  of  the  Council  of  29 April 
2004  amending  Council  Directive 96/48/EC  on  the  interoperability  of  the  trans-
European  high-speed  rail  system  and  Directive 2001/16/EC  of  the  European 
Parliament  and  of  the  Council  on  the  interoperability  of  the  trans-European 
conventional rail system25 and publication of the TSIs, including the adoption of the 
reference system mentioned in Article 25. 

(cid:208) 2001/16/EC 
(cid:214) new 

CHAPTER VII 

REGISTERS OF INFRASTRUCTURE AND ROLLING STOCK 

Article 24 

1.  The  Member  States  shall  ensure  that  registers  of  infrastructure  and  of  rolling  stock  are 
published  and  updated  (cid:214)  regularly    annually.  Those  registers  shall  indicate  the  main 
features  of  each  subsystem  or  part  subsystem  involved  (e.g.  the  basic  parameters)  and  their 
correlation  with  the  features  laid  down  by  the  applicable  TSIs.  To  that  end,  each  TSI  shall 
indicate precisely which information must be included in the registers of infrastructure and of 
rolling stock. 

25 

OJ L 164, 30.4.2004, p. 114. 

EN 

51 

   EN 

 
 
 
 
 
 
 
 
 
                                                 
2. A copy of those registers shall be sent to the Member States concerned and to the Agency 
and  shall  be  made  available  for  consultation  by  interested  parties,  including  at  least  the 
professional actors from the sector. 

(cid:208) 2004/50/EC Art. 2(16) 

(cid:216) new 

3. The Agency shall prepare a draft guide to implementing the registers of infrastructure and 
rolling stock; the guide shall specify the contents of the registers and recommend their format, 
revision cycle and instructions for use. The guide shall also set out the rules for implementing 
this Article with regard to infrastructures and rolling stock placed in service before the entry 
into  force  of  this  Directive.  The  Commission  shall  adopt  the  guide  after  consulting  the 
Committee in accordance with the procedure referred to in Article 21(2). 

(cid:208) 2004/50/EC Art. 1(18) 

Article 22a 

1. Member States shall ensure that a register of infrastructure and a register of rolling stock 
are published and updated annually. These registers shall indicate the main features of each 
subsystem or part subsystem involved, e.g. the basic parameters, and their correlation with the 
features  laid  down  by  the  applicable  TSIs.  To  that  end,  each  TSI  shall  indicate  precisely 
which information must be included in the registers of infrastructure and of rolling stock. 

2. A copy of those registers shall be sent to the Member States concerned and to the Agency 
and  shall  be  made  available  for  consultation  by  interested  parties,  including  at  least  the 
professional actors from the sector. 

(cid:208) 2001/16/EC 

CHAPTER VIII 

TRANSITIONAL PROVISIONS 

Article 25 

(cid:208) 2004/50/EC Art. 2(17)  
(cid:214) new 

1.  The  Agency  shall  develop,  in  accordance  with  Articles  3  and  12  of  Regulation (EC) 
No 881/2004,  on  the  basis  of  the  information  notified  by  the  Member  States  under 
Article 16(3),  technical  documents  from  the  profession  and  the  texts  of  the  relevant 
international  agreements,  a  draft  reference  system  of  technical  rules  ensuring  the  current 
degree of interoperability of the lines and rolling stock that will be brought within the scope 

EN 

52 

   EN 

 
 
 
 
 
 
of this Directive as defined in Article 1(3). The Commission, following the procedure set out 
in  Article 21(2),  shall  examine  this  draft  and  decide  whether  it  may  constitute  a  reference 
system  pending  the  adoption  of  TSIs.  (cid:214)  If  necessary,  the  Commission  shall  adopt  the 
reference system in accordance with the procedure referred to in Article 21(2).  

2. Following adoption of the abovementioned reference system, Member States shall inform 
the Committee (cid:214) the Commission  of their intention to adopt any national provision or of 
the development of any project in their territory which diverges from the reference system. 

(cid:208) 2001/16/EC (new) 
(cid:214) new 

(cid:208) 2004/50/EC Art. 2(17) 
(new) 

CHAPTER IX 

FINAL PROVISIONS 

Article 26 

Any  decision  taken  pursuant  to  this  Directive  concerning  the  assessment  of  conformity  or 
suitability for use of interoperability constituents, the checking of subsystems constituting the 
trans-European conventional rail system and any decision taken pursuant to Articles 11, 12, 
17 and 19 shall set out in detail the reasons on which it is based. It shall be notified as soon as 
possible to the party concerned, together with an indication of the remedies available  under 
the  laws  in  force  in  the  Member  State  concerned  and  of  the  time  limits  allowed  for  the 
exercise of such remedies. 

(cid:208)  

Article 27 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative  provisions 
necessary  to  comply  with  Articles  2  (points  q-r-s),  7,  10(5),  14,  16(3),  18(4)  and  (5),  24(1) 
and  Annexes  II  and  VII  not  later  than  […]26.  They  shall  forthwith  communicate  to  the 
Commission the text of those provisions and a correlation table between those provisions and 
this Directive. 

When Member States adopt those provisions, they shall contain a reference to this Directive 
or be accompanied by such a reference on the occasion of their official publication. 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 

26 

24 months after the entry into force of this Directive 

EN 

53 

   EN 

 
 
 
 
                                                 
Directive.  Member  States  shall  determine  how  such  reference  is  to  be  made  and  how  that 
statement is to be formulated. 

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:208) 2001/16/EC (adapted) 
(cid:214) new 

Article 28 

Every two (cid:214) three  years, and for the first time 20 April 2005 the Commission shall report 
to  the  European  Parliament  and  the  Council  on  the  progress  made  towards  achieving 
interoperability of the trans-European conventional rail system. That report shall also include 
an analysis of the cases set out in Article 7. 

(cid:208) 2001/16/EC (adapted) 
(cid:214) new 

The  joint  representative  body  (cid:214)  The  Agency    shall  develop  and  regularly  update  a  tool 
capable  of  providing,  at  the  request  of  a  Member  State  or  the  Commission,  a  chart  of  the 
interoperability level of the trans-European conventional rail system. That tool shall use the 
information available in the registers provided for in Article 24. 

(cid:216) new 

Article 29 

Directives  96/48/EC  and  2001/16/EC,  as  amended  by  Directive  2004/50/EC,  are  repealed 
with effect from […]27,without prejudice to the obligations of the Member States concerning 
the time limits for transposition into national law and application of the said Directives. 

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

(cid:208) 96/48/EC and 2001/16/EC 
(adapted) 

Article 2930 

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

27 

Date indicated in the first subparagraph of Article 27. 

EN 

54 

   EN 

 
 
 
 
 
                                                 
Articles 1, 2 (from (a) to (p)), 3, 4, 5, 6, 8, 9, 10(1) to (4), 11, 12, 13, 15, 16(1) and (2), 17, 
18(1) to (3), 19 to 23, 24(2) and (3), 25 to 31 and Annexes I and III to VII shall apply from 
the above date of entry into force. 

(cid:208)  

(cid:208) 96/48/EC and 2001/16/EC 

This Directive is addressed to the Member States. 

Article 3031 

EN 

55 

   EN 

 
 
 
(cid:208) 2004/50/EC Art. 2, pt 18 and 
Annex III (adapted) 

ANNEX I 

⌦ SCOPE ⌫ 

1. THE TRANS-EUROPEAN CONVENTIONAL RAIL SYSTEM 

1.1. INFRASTRUCTURE 

The infrastructure of the trans-European conventional rail system will be that on the lines of 
the  trans-European  transport  network  identified  in  Decision  No 1692/96/EC  of  the 
European Parliament  and  of  the  Council  of  23 July 1996  on  Community  guidelines  for  the 
development  of  the  trans-European  transport  network28  or  listed  in  any  update  to  the  same 
Decision as a result of the revision provided for in Article 21 of that Decision. 

For  the  purposes  of  this  Directive,  this  network  may  be  subdivided  into  the  following 
categories: 

– 

– 

– 

– 

– 

– 

lines intended for passenger services; 

lines intended for mixed traffic (passengers and freight); 

lines specially designed or upgraded for freight services; 

passenger hubs; 

freight hubs, including intermodal terminals; 

lines connecting the abovementioned elements. 

This  infrastructure  includes  traffic  management,  tracking,  and  navigation  systems:  technical 
installations for data processing and telecommunications intended for long-distance passenger 
services  and  freight  services  on  the  network  in  order  to  guarantee  the  safe  and  harmonious 
operation of the network and efficient traffic management. 

1.2. ROLLING STOCK 

The  rolling  stock  will  comprise  all  the  stock  likely  to  travel  on  all  or  part  of  the  trans-
European conventional rail network, including: 

– 

– 

28 

self-propelling thermal or electric trains; 

thermal or electric traction units; 

OJ  L 228, 09.9.1996, p. 1. Decision  as  amended by  Decision  No 1346/2001/EC  (OJ  L 185,  6.7.2001, 
p. 1). 

EN 

56 

   EN 

 
 
                                                 
– 

– 

passenger carriages; 

freight wagons, including rolling stock designed to carry lorries. 

Mobile railway infrastructure construction and maintenance equipment is included but is not 
the first priority. 

Each of the above categories is subdivided into: 

– 

– 

rolling stock for international use; 

rolling stock for national use. 

(cid:208) 2004/50/EC Art. 1, pt 19 and 
Annex I (adapted) 
(cid:214) new 

2. THE TRANS-EUROPEAN HIGH-SPEED RAIL SYSTEM 

2.1. INFRASTRUCTURE 

The infrastructure of the trans-European high-speed rail system shall be that of the lines of the 
trans-European 
the 
European Parliament  and  of  the  Council  of  23 July 1996  on  Community  guidelines  for  the 
development  of  the  trans-European  transport  network29  or  listed  in  any  update  of  that 
Decision as a result of the revision provided for in Article 21 of that Decision. 

in  Decision  No 1692/96/EC  of 

transport  network 

identified 

The high-speed lines shall comprise: 

– 

– 

– 

specially  built  high-speed  lines  equipped  for  speeds  generally  equal  to  or 
greater than 250 km/h, 

specially upgraded high-speed lines equipped for speeds of the order of 200 km/h, 

specially  upgraded  high-speed  lines  which  have  special  features  as  a  result  of 
topographical,  relief  or  town-planning  constraints,  on  which  the  speed  must  be 
adapted  to  each  case.  (cid:214)  This  category  also  includes  interconnecting  lines  between 
the  high-speed  and  conventional  networks,  lines  through  stations,  accesses  to 
terminals, depots, etc. travelled at conventional speed by "high-speed" rolling stock. 
 

This  infrastructure  includes  traffic  management,  tracking,  and  navigation  systems:  technical 
installations  for  data  processing  and  telecommunications  intended  for  passenger  services  on 
these  lines  in  order  to  guarantee  the  safe  and  harmonious  operation  of  the  network  and 
efficient traffic management. 

29 

OJ  L 228, 09.9.1996, p. 1. Decision  as  amended by  Decision  No 1346/2001/EC  (OJ  L 185,  6.7.2001, 
p. 1). 

EN 

57 

   EN 

 
 
                                                 
2.2. ROLLING STOCK 

The rolling stock referred to in this Directive shall comprise trains designed to operate: 

– 

– 

either  at  speeds  of  at  least  250 km/h  on  lines  specially  built  for  high  speeds,  while 
enabling operation at speeds exceeding 300 km/h in appropriate circumstances, 

or at speeds of the order of 200 km/h on the lines of section 1, where compatible with 
the performance levels of these lines. 

(cid:208) 2004/50/EC Art. 2, pt 18 and 
Annex III (adapted) 

3.  COMPATIBILITY  OF  THE  TRANS-EUROPEAN  CONVENTIONAL  RAILWAY 

SYSTEM 

(cid:208) 2004/50/EC Art. 1, pt 19 and 
Annex I and Art. 2, pt 18 and 
Annex III 

The quality of rail services in Europe depends, inter alia, on excellent compatibility between 
the  characteristics  of  the  infrastructure  (in  the  broadest  sense,  i.e.  the  fixed  parts  of  all  the 
subsystems concerned) and those of the rolling stock (including the onboard components of 
all  the  subsystems  concerned).  Performance  levels,  safety,  quality  of  service  and  cost 
depend upon that compatibility. 

4. EXTENSION OF THE SCOPE 

4.1. Subcategories of lines and rolling stock 

In  order  to  deliver  interoperability  cost-effectively  further  subcategories  of  all  categories  of 
lines  and  rolling  stock  mentioned  in  this  Annex  will,  where  necessary,  be  developed. 
If necessary,  the  functional  and  technical  specifications  mentioned  in  Article 5(3)  may  vary 
according to the subcategory. 

4.2. Cost safeguards 

The cost-benefit analysis of the proposed measures will take into consideration, among others, 
the following: 

– 

– 

– 

– 

cost of the proposed measure, 

reduction of capital costs and charges due to economies of scale and better utilisation 
of rolling stock, 

reduction  of 
competition between manufacturers and maintenance companies, 

investment  and  maintenance/operating  costs  due 

to 

increased 

environmental benefits, due to technical improvements of the rail system, 

EN 

58 

   EN 

 
 
 
– 

increase of safety in operation. 

In  addition,  this  assessment  will  indicate  the  likely  impact  for  all  the  operators  and 
economic agents involved. 

EN 

59 

   EN 

 
(cid:208) 2001/16/EC (adapted) 

ANNEX II 

SUBSYSTEMS 

1. LIST OF SUBSYSTEMS 

For  the  purposes  of  this  Directive,  the  system  constituting  the  trans-European  conventional 
rail system may be broken down into the following two subsystems, either: 

(cid:208) 2001/16/EC and 2004/50/EC 
Art. 1, pt 20 and Annex II 
(adapted) 
(cid:214) new 

(a) structural areas: 

– 

– 

– 

– 

– 

infrastructure; 

energy; 

control and command and signalling; 

traffic operation and management; 

rolling stock; 

or (b) operational areas: 

–  (cid:214) traffic operation and management  ,  

– 

– 

maintenance; 

telematics applications for passenger and freight services. 

(cid:208) 2004/50/EC Art. 1, pt 20 and 
Annex II 

2. AREAS TO BE COVERED 

For each subsystem, the list of aspects relating to interoperability is indicated in the mandates 
for drawing up TSIs given to the Agency. 

Under Article 6(1), these mandates shall be established in accordance with the procedure set 
out in Article 21(2). 

Where  necessary,  the  list  of  aspects  relating  to  interoperability  indicated  in  the  mandates  is 
specified by the Agency in accordance with Article 5(3)(c). 

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(cid:208) 2001/16/EC and 2004/50/EC 
Art. 1(20) and Annex II (adapted) 
(cid:214) new 

2. DESCRIPTION OF THE SUBSYSTEMS 

For  each  subsystem  or  part  of  a  subsystem,  the  list  of  constituents  and  aspects  relating  to 
interoperability is proposed by the joint representative body (cid:214) the Agency  at the time of 
drawing up the relevant draft TSI. 

Without  prejudging  the  choice  of  aspects  and  constituents  relating  to  interoperability  or  the 
order in which they will be made subject to TSIs, the subsystems include, in particular: 

2.1. Infrastructure: 

The  track,  points,  engineering  structures  (bridges,  tunnels,  etc.),  associated  station 
infrastructure  (platforms,  zones  of  access,  including  the  needs  of  persons  with  reduced 
mobility, etc.), safety and protective equipment. 

2.2. Energy 

The electrification system, ⌦ and ⌫ overhead lines. and current collectors. 

2.3. Control and command and signalling 

All  the  equipment  necessary  to  ensure  safety  and  to  command  and  control  movements  of 
trains authorised to travel on the network. 

2.4. Operation and traffic management 

The procedures and related equipment enabling a coherent operation of the different structural 
subsystems,  both  during  normal  and  degraded  operation,  including  in  particular  (cid:214)  training 
and  train driving, traffic planning and management. 

The professional qualifications which may be required for carrying out cross-border services. 

2.5. Telematics applications: 

In accordance with Annex I, this subsystem comprises two elements: 

(a) applications for passenger services, including systems providing passengers with 
information  before  and  during  the  journey,  reservation  and  payment  systems, 
luggage management and management of connections between trains and with other 
modes of transport; 

(b)  applications  for  freight  services,  including  information  systems  (real-time 
monitoring  of  freight  and  trains),  marshalling  and  allocation  systems,  reservation, 
payment  and  invoicing  systems,  management  of  connections  with  other  modes  of 
transport and production of electronic accompanying documents. 

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2.6. Rolling stock 

Structure, command and control system for all train equipment, (cid:214) current-collection devices 
  traction  and  energy  conversion  units,  braking,  coupling  and  running  gear  (bogies,  axles, 
etc.)  and  suspension,  doors,  man/machine  interfaces  (driver,  on-board  staff  and  passengers, 
including  the  needs  of  persons  with  reduced  mobility),  passive  or  active  safety  devices  and 
requisites for the health of passengers and on-board staff. 

2.7. Maintenance 

The  procedures,  associated  equipment,  logistics  centres  for  maintenance  work  and  reserves 
allowing the mandatory corrective and preventive maintenance to ensure the interoperability 
of the rail system and guarantee the performance required. 

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(cid:208) 96/48/EC and 2001/16/EC 

ANNEX III 

ESSENTIAL REQUIREMENTS 

1. GENERAL REQUIREMENTS 

1.1. Safety 

1.1.1.  The  design,  construction  or  assembly,  maintenance  and  monitoring  of  safety-critical 
components, and more particularly of the components involved in train movements must be 
such as to guarantee safety at the level corresponding to the aims laid down for the network, 
including those for specific degraded situations. 

1.1.2. The parameters involved in the wheel/rail contact must meet the stability requirements 
needed in order to guarantee safe movement at the maximum authorized speed. 

1.1.3. The components used must withstand any normal or exceptional stresses that have been 
specified  during  their  period  in  service.  The  safety  repercussions  of  any  accidental  failures 
must be limited by appropriate means. 

1.1.4. The design of fixed installations and rolling stock and the choice of the materials used 
must  be  aimed  at  limiting  the  generation,  propagation  and  effects  of  fire  and  smoke  in  the 
event of a fire. 

1.1.5. Any devices intended to be handled by users must be so designed as not to impair the 
safe operation of the devices or the health and safety of users if used foreseeably in a manner 
not in accordance with the posted instructions. 

1.1.5. Any devices intended to be handled by users must be so designed as not to impair their 
safety if used foreseeably in a manner not in accordance with the posted instructions. 

(cid:208) 96/48/EC (adapted) 

(cid:208) 96/48/EC and 2001/16/EC 

1.2. Reliability and availability 

The monitoring and maintenance of fixed or movable components that are involved in train 
movements  must  be  organized,  carried  out  and  quantified  in  such  a  manner  as  to  maintain 
their operation under the intended conditions. 

1.3. Health 

1.3.1.  Materials  likely,  by  virtue  of  the  way  they  are  used,  to  constitute  a  health  hazard  to 
those having access to them must not be used in trains and railway infrastructures. 

1.3.2.  Those  materials  must  be  selected,  deployed  and  used  in  such  a  way  as  to  restrict  the 
emission of harmful and dangerous fumes or gases, particularly in the event of fire. 

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1.4. Environmental protection 

1.4.1.  The  environmental  impact  of  establishment  and  operation  of  the  trans-European 
conventional  rail  system  must  be  assessed  and  taken  into  account  at  the  design  stage  of  the 
system in accordance with the Community provisions in force. 

(cid:208) 2001/16/EC (new) 

(cid:208) 96/48/EC and 2001/16/EC 

1.4.2. The materials used in the trains and infrastructures must prevent the emission of fumes 
or gases which are harmful and dangerous to the environment, particularly in the event of fire. 

1.4.3.  The  rolling  stock  and  energy-supply  systems  must  be  designed  and  manufactured  in 
such  a  way  as  to  be  electromagnetically  compatible  with  the  installations,  equipment  and 
public or private networks with which they might interfere. 

(cid:208) 2001/16/EC (new) 

1.4.4.  Operation  of  the  trans-European  conventional  rail  system  must  respect  existing 
regulations on noise pollution. 

1.4.5.  Operation  of  the  trans-European  conventional  rail  system  must  not  give  rise  to  an 
inadmissible level of ground vibrations for the activities and areas close to the infrastructure 
and in a normal state of maintenance. 

1.5. Technical compatibility 

The technical characteristics of the infrastructure and fixed installations must be compatible 
with each other and with those of the trains to be used on the trans-European conventional rail 
system. 

If  compliance  with  these  characteristics  proves  difficult  on  certain  sections  of  the  network, 
temporary solutions, which ensure compatibility in the future, may be implemented. 

(cid:208) 96/48/EC and 2001/16/EC 

2. REQUIREMENTS SPECIFIC TO EACH SUBSYSTEM 

2.1. Infrastructure 

2.1.1. Safety 

Appropriate  steps  must  be  taken  to  prevent  access  to  or  undesirable  intrusions  into 
installations. 

(cid:208) 2001/16/EC 

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Steps  must  be  taken  to  limit  the  dangers  to  which  persons  are  exposed,  particularly  when 
trains pass through stations. 

(cid:208) 96/48/EC and 2001/16/EC 

Infrastructure to which the public has access must be designed and made in such a way as to 
limit any human safety hazards (stability, fire, access, evacuation, platforms, etc.). 

Appropriate provisions must be laid down to take account of the particular safety conditions 
in very long tunnels. 

2.2. Energy 

2.2.1. Safety 

Operation  of  the  energy-supply  systems  must  not  impair  the  safety  either  of  trains  or  of 
persons (users, operating staff, trackside dwellers and third parties). 

(cid:208) 2001/16/EC 

2.2.2. Environmental protection 

The functioning of the electrical or thermal energy-supply systems must not interfere with the 
environment beyond the specified limits. 

2.2.3. Technical compatibility 

The electricity/thermal energy supply systems used must: 

– 

enable trains to achieve the specified performance levels; 

(cid:208) 96/48/EC and 2001/16/EC 

– 

be compatible with the collection devices fitted to the trains. 

(cid:208) 96/48/EC 

– 

in  the  case  of  electricity  energy  supply  systems,  be  compatible  with  the  collection 
devices fitted to the trains. 

(cid:208) 2001/16/EC 

2.3. Control and command and signalling 

2.3.1. Safety 

(cid:208) 2001/16/EC 

The control and command and signalling installations and procedures used must enable trains 
to travel with a level of safety which corresponds to the objectives set for the network. The 

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control and command and signalling systems should continue to provide for safe passage of 
trains permitted to run under degraded conditions. 

2.3.2. Technical compatibility 

All new infrastructure and all new rolling stock manufactured or developed after adoption of 
compatible  control  and  command  and  signalling  systems  must  be  tailored  to  use  of  those 
systems. 

The control and command and signalling equipment installed in the train drivers' cabs must 
permit  normal  operation,  under  the  specified  conditions,  throughout  the  trans-European 
conventional rail system. 

(cid:208) 96/48/EC and 2001/16/EC 

2.4. Rolling stock 

2.4.1. Safety 

The rolling-stock structures and those of the links between vehicles must be designed in such 
a  way  as  to  protect  the  passenger  and  driving  compartments  in  the  event  of  collision  or 
derailment. 

The  electrical  equipment  must  not  impair  the  safety  and  functioning  of  the  control  and 
command and signalling installations. 

The  braking  techniques  and  the  stresses  exerted  must  be  compatible  with  the  design  of  the 
tracks, engineering structures and signalling systems. 

Steps must be taken to prevent access to electrically-live constituents in order not to endanger 
the safety of persons. 

In the event of danger devices must enable passengers to inform the driver and accompanying 
staff to contact him. 

The access doors must incorporate an opening and closing system which guarantees passenger 
safety. 

Emergency exits must be provided and indicated. 

Appropriate provisions must be laid down to take account of the particular safety conditions 
in very long tunnels. 

An  emergency  lighting  system  having  a  sufficient  intensity  and  duration  is  an  absolute 
requirement on board trains. 

Trains  must  be  equipped  with  a  public  address  system  which  provides  a  means  of 
communication to the public from on-board staff and ground control. 

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2.4.2. Reliability and availability 

The design of the vital equipment and the running, traction and braking equipment and also 
the control and command system must, in a specific degraded situation, be such as to enable 
the train to continue without adverse consequences for the equipment remaining in service. 

2.4.3. Technical compatibility 

The electrical equipment must be compatible with the operation of the control and command 
and signalling installations. 

In  the  case  of  electric  traction,  the  characteristics  of  the  current-collection  devices  must  be 
such  as  to  enable  trains  to  travel  under  the  energy-supply  systems  for  the  trans-European 
conventional rail system. 

(cid:208) 2001/16/EC 

The  characteristics  of  the  rolling  stock  must  be  such  as  to  allow  it  to  travel  on  any  line  on 
which it is expected to operate. 

(cid:208) 96/48/EC and 2001/16/EC 

(cid:208) 2004/50/EC Art. 1(21) and Art. 
2(19) 

2.4.4. Controls 

Trains must  be equipped  with a  recording device. The data collected by this device and the 
processing of the information must be harmonised. 

(cid:208) 2001/16/EC 

2.5. Maintenance 

2.5.1. Health and safety 

The  technical  installations  and  the  procedures  used  in  the  centres  must  ensure  the  safe 
operation of the subsystem and not constitute a danger to health and safety. 

2.5.2. Environmental protection 

The  technical  installations  and  the  procedures  used  in  the  maintenance  centres  must  not 
exceed the permissible levels of nuisance with regard to the surrounding environment. 

(cid:208) 96/48/EC and 2001/16/EC 

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2.5.3. Technical compatibility 

The maintenance installations for conventional rolling stock must be such as to enable safety, 
health  and  comfort  operations  to  be  carried  out  on  all  stock  for  which  they  have  been 
designed. 

(cid:208) 2001/16/EC 

(cid:208) 96/48/EC (adapted) 

2.6. Environment 

2.6.1. Health 

Operation  of  the  trans-European  high-speed  rail  system  must  remain  within  the  statutory 
noise-nuisance limits. 

2.6.2. Environmental protection 

Operation  of  the  trans-European  high-speed  rail  system  must  not  cause  a  level  of  ground 
vibrations which is unacceptable for activities and the immediate environment in the vicinity 
of the infrastructure and in a normal state of maintenance. 

2.7. Operation 

2.6. Operation and traffic management 

2.6.1. Safety 

(cid:208) 2001/16/EC 

(cid:208) 96/48/EC 

Alignment of the network operating rules and the qualifications of drivers and on-board staff 
must be such as to ensure safe international operation. 

(cid:208) 2001/16/EC 

Alignment of the network operating rules and the qualifications of drivers and on-board staff 
and  of  the  staff  in  the  control  centres  must  be  such  as  to  ensure  safe  operation,  bearing  in 
mind the different requirements of cross-border and domestic services. 

The maintenance operations and intervals, the training and qualifications of the maintenance 
and control centre staff and the quality assurance system set up by the operators concerned in 
the control and maintenance centres must be such as to ensure a high level of safety. 

2.6.2. Reliability and availability 

The  maintenance  operations  and  periods,  the  training  and  qualifications  of  the  maintenance 
and control centre staff and the quality assurance system set up by the operators concerned in 

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the  control  and  maintenance  centres  must  be  such  as  to  ensure  a  high  level  of  system 
reliability and availability. 

2.6.3. Technical compatibility 

Alignment of the network operating rules and the qualifications of drivers, on-board staff and 
traffic  managers  must  be  such  as  to  ensure  operating  efficiency  on  the  trans-European 
conventional  rail  system,  bearing  in  mind  the  different  requirements  of  cross-border  and 
domestic services. 

2.7. Telematics applications for freight and passengers 

2.7.1. Technical compatibility 

The essential requirements for telematics applications guarantee a minimum quality of service 
for passengers and carriers of goods, particularly in terms of technical compatibility. 

Steps must be taken to ensure: 

– 

– 

that  the  databases,  software  and  data  communication  protocols  are  developed  in  a 
manner  allowing  maximum  data  interchange  between  different  applications  and 
operators, excluding confidential commercial data; 

easy access to the information for users. 

2.7.2. Reliability and availability 

The methods of use, management, updating and maintenance of these databases, software and 
data communication protocols must guarantee the efficiency of these systems and the quality 
of the service. 

2.7.3. Health 

The  interfaces  between  these  systems  and  users  must  comply  with  the  minimum  rules  on 
ergonomics and health protection. 

2.7.4. Safety 

Suitable levels of integrity and dependability must be provided for the storage or transmission 
of safety-related information. 

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ANNEX IV 

CONFORMITY AND SUITABILITY FOR USE OF INTEROPERABILITY 
CONSTITUENTS 

(cid:208) 96/48/EC (adapted) 

EC DECLARATION 

– 

– 

of conformity 

of suitability for use 

1. INTEROPERABILITY CONSTITUENTS 

(cid:208) 2001/16/EC (adapted) 

the 
The  «EC»  declaration  applies 
interoperability  of  the  trans-European  conventional  rail  system,  as  referred  to  in  Article  3. 
These interoperability constituents may be: 

interoperability  constituents 

involved 

the 

in 

to 

(cid:208) 96/48/EC and 2001/16/EC 

1.1. Multiple-use constituents 

These are constituents that are not specific to the railway system and which may be used as 
such in other areas. 

1.2. Multiple-use constituents having specific characteristics 

These are constituents which are not, as such, specific to the railway system, but which must 
display specific performance levels when used for railway purposes. 

1.3. Specific constituents 

These are constituents that are specific to railway applications. 

2. SCOPE 

The «EC» declaration covers: 

– 

– 

either the assessment by a notified body or bodies of the intrinsic conformity of an 
interoperability constituent, considered in isolation, to the technical specifications to 
be met; 

or the assessment/judgement by a notified body or bodies of the suitability for use of 
an  interoperability  constituent,  considered  within  its  railway  environment  and,  in 

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particular  in  cases  where  the  interfaces  are  involved,  in  relation  to  the  technical 
specifications, particularly those of a functional nature, which are to be checked. 

The assessment procedures implemented by the notified bodies at the design and production 
stages will draw upon the modules defined in Decision 93/465/EEC, in accordance with the 
conditions referred to in the TSIs. 

3. CONTENTS OF THE «EC» DECLARATION 

The  «EC»  declaration  of  conformity  or  of  suitability  for  use  and  the  accompanying 
documents must be dated and signed. 

That declaration must be written in the same language as the instructions and must contain the 
following: 

– 

– 

– 

– 

– 

– 

– 

– 

the Directive references; 

name  and  address  of  the  manufacturer  or  its  authorized  representative  established 
within  the  Community  (give  trade  name  and  full  address;  in  the  case  of  the 
authorised  representative,  also  give  the  trade  name  of  the  manufacturer  or 
constructor); 

description of interoperability constituent (make, type, etc.); 

description of the procedure followed in order to declare conformity or suitability for 
use (Article 13); 

all the relevant descriptions met by the interoperability constituent and, in particular, 
its conditions of use; 

name and address of the notified body or bodies involved in the procedure followed 
in  respect  of  conformity  or  suitability  for  use  and  date  of  examination  certificate 
together  with,  where  appropriate,  the  duration  and  conditions  of  validity  of  the 
certificate; 

where appropriate, reference to the European specifications; 

identification of the signatory empowered to enter into commitments on behalf of the 
manufacturer  or  of  the  manufacturer's  authorised  representative  established  within 
the Community. 

(cid:208) 2001/16/EC 

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ANNEX V 

DECLARATION OF VERIFICATION OF SUBSYSTEMS 

(cid:208) 96/48/EC and 2001/16/EC 
(cid:214) new 

The  «EC»  declaration  of  verification  and  the  accompanying  documents  must  be  dated  and 
signed. 

That declaration must be written in the same language as the technical file and must contain 
the following: 

– 

– 

– 

– 

– 

– 

– 

– 

the Directive references; 

name and address of the contracting entity (cid:214) or the constructor , or its authorized 
representative established within the Community (give trade name and full address; 
in  the  case  of  the  authorised  representative,  also  give  the  trade  name  of  the 
contracting entity (cid:214) or the constructor  ); 

a brief description of the subsystem; 

name  and  address  of  the  notified  body  which  conducted  the  «EC»  verification 
referred to in Article 18; 

the references of the documents contained in the technical file; 

all  the  relevant  temporary  or  definitive  provisions  to  be  complied  with  by  the 
subsystems  and  in  particular,  where  appropriate,  any  operating  restrictions  or 
conditions; 

if temporary: duration of validity of the «EC» declaration; 

identity of the signatory. 

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(cid:208) 2001/16/EC 

ANNEX VI 

VERIFICATION PROCEDURE FOR SUBSYSTEMS 

1. INTRODUCTION 

(cid:208) 96/48/EC and 2001/16/EC 
(cid:214) new 

«EC» verification is the procedure whereby a notified body checks and certifies, at the request 
of the contracting entity or (cid:214) the constructor or their  authorised representative established 
within the Community, that a subsystem: 

– 

– 

complies with the Directive; 

complies with the other regulations deriving from the Treaty, 

and may be put into operation. 

2. STAGES 

The subsystem is checked at each of the following stages: 

– 

– 

– 

overall design; 

construction  of  subsystem,  including,  in  particular,  civil-engineering  activities, 
constituent assembly, overall adjustment; 

final testing of the subsystem. 

3. CERTIFICATE 

The  notified  body  responsible  for  «EC»  verification  draws  up  the  certificate  of  conformity 
intended for the contracting entity or (cid:214) the constructor or their  authorised representative 
established  within  the  Community,  which  in  turn  draws  up  the  «EC»  declaration  of 
verification  intended  for  the  supervisory  authority  in  the  Member  State  in  which  the 
subsystem is located and/or operates. 

4. TECHNICAL FILE 

The technical file accompanying the declaration of verification must be made up as follows: 

– 

for infrastructure: engineering-structure plans, approval records for excavations and 
reinforcement, testing and inspection reports on concrete; 

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– 

– 

– 

– 

for  the  other  subsystems:  general  and  detailed  drawings  in  line  with  execution, 
electrical  and  hydraulic  diagrams,  control-circuit  diagrams,  description  of  data-
processing and automatic systems, operating and maintenance manuals, etc.; 

list of interoperability constituents, as referred to in Article 3, incorporated into the 
subsystem; 

copies of the «EC» declarations of conformity or suitability for use with which the 
abovementioned constituents must be provided in accordance with Article 13 of the 
Directive  accompanied,  where  appropriate,  by  the  corresponding  calculation  notes 
and  a  copy  of  the  records  of  the  tests  and  examinations  carried  out  by  the  notified 
bodies on the basis of the common technical specifications; 

certificate from the notified body responsible for «EC» verification, accompanied by 
corresponding  calculation  notes  and  countersigned  by  itself,  stating  that  the  project 
complies  with  this  Directive  and  mentioning  any  reservations  recorded  during 
performance  of  the  activities  and  not  withdrawn;  the  certificate  should  also  be 
accompanied  by  the  inspection  and  audit  reports  drawn  up  by  the  same  body  in 
connection with its task, as specified in sections 5.3 and 5.4. 

5. MONITORING 

5.1. The aim of «EC» monitoring is to ensure that the obligations deriving from the technical 
file have been met during production of the subsystem. 

5.2.  The  notified  body  responsible  for  checking  production  must  have  permanent  access  to 
building sites, production workshops, storage areas and, where appropriate, prefabrication or 
testing facilities and, more generally, to all premises which it considers necessary for its task. 
The  contracting  entity  or  (cid:214)  the  constructor  or  their    authorised  representative  within  the 
Community must send it or have sent to it all the documents needed for that purpose and, in 
particular, the implementation plans and technical documentation concerning the subsystem. 

5.3.  The  notified  body  responsible  for  checking  implementation  must  periodically  carry  out 
audits in order to confirm compliance with the Directive. It must provide those responsible for 
implementation  with  an  audit  report.  It  may  require  to  be  present  at  certain  stages  of  the 
building operations. 

5.4.  In  addition,  the  notified  body  may  pay  unexpected  visits  to  the  worksite  or  to  the 
production workshops. At the time of such visits the notified body may conduct complete or 
partial audits. It must provide those responsible for implementation with an inspection report 
and, if appropriate, an audit report. 

6. SUBMISSION 

The complete file referred to in paragraph 4 must be lodged with the contracting entity or (cid:214) 
the  constructor  or  their    authorised  representative  established  within  the  Community  in 
support of the certificate of conformity issued by the notified body responsible for verification 
of  the  subsystem  in  working  order.  The  file  must  be  attached  to  the  «EC»  declaration  of 
verification  which  the  contracting  entity  (cid:214)  or  the  constructor    sends  to  the  supervisory 
authority in the Member State concerned. 

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A  copy  of  the  file  must  be  kept  by  the  contracting  entity  throughout  the  service  life  of  the 
subsystem. It must be sent to any other Member States which so request. 

7. PUBLICATION 

Each notified body must periodically publish relevant information concerning: 

– 

– 

– 

requests for «EC» verification received; 

certificates of conformity issued; 

certificates of conformity refused. 

8. LANGUAGE 

The files and correspondence relating to the «EC» verification procedures must be written in 
an official language of the Member State in which the contracting entity or (cid:214) the constructor 
or  their    authorised  representative  within  the  Community  is  established  or  in  a  language 
accepted by the entity. 

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ANNEX VII 

MINIMUM CRITERIA WHICH MUST BE TAKEN INTO ACCOUNT BY THE 
MEMBER STATES WHEN NOTIFYING BODIES 

1.  The  body,  its  Director  and  the  staff  responsible  for  carrying  out  the  checking  operations 
may  not  become  involved  either  directly  or  as  authorized  representatives  in  the  design, 
manufacture,  construction,  marketing  or  maintenance  of  the  interoperability  constituents  or 
subsystems or in their use. This does not exclude the possibility of an exchange of technical 
information between the manufacturer or constructor and that body. 

2.  The  body  and  the  staff  responsible  for  the  checks  must  carry  out  the  checks  with  the 
greatest  possible  professional  integrity  and  the  greatest  possible  technical  competence  and 
must be free of any pressure and incentive, in particular of a financial type, which could affect 
their  judgement  or  the  results  of  their  inspection,  in  particular  from  persons  or  groups  of 
persons affected by the results of the checks. 

(cid:208) 2004/50/EC Art. 1(22) and Art. 
2( 20) 

In  particular,  the  body  and  the  staff  responsible  for  the  checks  must  be  functionally 
independent of the authorities designated to issue authorisations for placing in service in the 
framework  of  this  Directive,  licences  in  the  framework  of  Council  Directive 95/18/EC  of 
19 June 1995  on  the  licensing  of  railway  undertakings30  and  safety  certificates  in  the 
framework of Directive 200./49/EC, and of the bodies in charge of investigations in the event 
of accidents. 

(cid:208) 2001/16/EC 

3.  The  body  must  employ  staff  and  possess  the  means  required  to  perform  adequately  the 
technical  and  administrative  tasks  linked  with  the  checks;  it  should  also  have  access  to  the 
equipment needed for exceptional checks. 

4. The staff responsible for the checks must possess: 

– 

– 

– 

proper technical and vocational training; 

a  satisfactory  knowledge  of  the  requirements  relating  to  the  checks  that  they  carry 
out and sufficient practice in those checks; 

the ability to draw up the certificates, records and reports which constitute the formal 
record of the inspections conducted. 

5. The independence of the staff responsible for inspections must be guaranteed. No official 
must  be  remunerated  either  on  the  basis  of  the  number  of  inspections  performed  or  of  the 
results of those inspections. 

30 

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). 

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6. The body must take out civil liability insurance unless that liability is covered by the State 
under national law or unless the checks are carried out directly by that Member State. 

7.  The  staff  of  the  body  are  bound  by  professional  secrecy  with  regard  to  everything  they 
learn in the performance of their duties (with the exception of the competent  administrative 
authorities in the State where they perform those activities) in pursuance of this Directive or 
any provision of national law implementing the Directive. 

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(cid:216) new 

ANNEX VIII 

FILE FOR SUBMITTING A DEROGATION 

When  submitting  a  request  for  a  derogation,  Member  States  must  supply  the  following 
documents: 

(a) 

A formal letter communicating the proposed derogation to the Commission 

(b) 

A file, annexed to the letter, comprising at least: 

– 

– 

– 

– 

– 

– 

– 

a  description  of  the  work,  goods  and  services  subject  to  the  derogation, 
specifying  the  key  dates,  the  geographical  location  and  the  operational  and 
technical area; 

a  precise  reference  to  the  TSIs  (or  their  parts)  for  which  a  derogation  is 
requested; 

a  precise  reference  to  and  details  of  the  alternative  provisions  which  will  be 
applied; 

for  requests  made  under  Article  7(a),  justification  of  the  advanced  stage  of 
development of the project; 

justification  of  the  derogation,  including  the  main  reasons  of  a  technical, 
economic, commercial, operational and/or administrative nature; 

any other information justifying the request for a derogation; 

a description of the measures that the Member State proposes to take in order 
to  promote  the  final  interoperability  of  the  project.  In  the  case  of  a  minor 
derogation, this description is not required. 

Documentation  must  be  supplied  in  paper  form  and  as  electronic  files,  so  that  it  can  be 
distributed among the members of the Committee. 

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(cid:207) 

ANNEX IX 

Part A 

Directives repealed together with their amendments 
(referred to in Article 29) 

Council Directive 96/48/EC 

(OJ L 235, 17.9.1996, p. 6) 

Directive 
of 
Parliament and of the Council 

2001/16/EC 

the  European 

(OJ L 110, 20.4.2001, p. 1) 

Regulation (EC) No 1882/2003 of the European 
Parliament and of the Council 

Only point 60 of Annex III 

(OJ L 284, 31.10.2003, p. 1) 

of 
Directive 
Parliament and of the Council 

2004/50/EC 

the  European 

(OJ L 164, 30.4.2004) 

Part B 

Time limits for transposition into national law(referred to in Article 29) 

Directive 

Deadline for transposition 

96/48/EC 

2001/16/EC 

2004/50/EC 

8 June 1999 

20 April 2003 

30 April 2006 

______________ 

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ANNEX X 

CORRELATION TABLE 

Directive 96/48/EC 

Directive 2001/16/EC 

This Directive 

Article 1(1) 

Article 1(2) 

- 

Article 1(1) 

Article 1(2) 

Article 1(3) 

Article 1(1) 

Article 1(2) 

Article 1(3) 

Article 2, introductory words 

Article 2, introductory words  Article 2, introductory words 

Article 2(a) to (l) 

Article 2(a) to (l) 

Article 2(a) to (l) 

Article 2(n) 

Article 2(o) 

Article 2(m) 

Article 2(p) 

- 

Article 2(m) 

Article 2(n) 

Article 2(o) 

Article 2(p) 

- 

Article 2(m) 

Article 2(n) 

Article 2(o) 

Article 2(p) 

Article 2(q), (r) and (s) 

Articles 3, 4 and 5 

Articles 3, 4 and 5 

Articles 3, 4 and 5 

Article 6(1) to (8) 

Article 6(1) to (8) 

Article 6(1) to (8) 

- 

-  

Article 6(9) 

Articles 7 to 9 

Articles 7 to 9 

Articles 7 to 9 

Article 10(1) to (3) 

Article 10(1) to (3) 

Article 10(1) to (3) 

-  

- 

Article 10(6) 

- 

Article 10(4) 

Article 10(5) 

Articles 11 to 13 

Articles 11 to 13 

Articles 11 to 13 

Article 14(1) to (5) 

Article 14(1) to (5) 

Article 14(1) to (5) 

- 

- 

Article 14(6) to (9) 

Articles 15 and 16 

Articles 15 and 16 

Articles 15 and 16 

Article 17 

- 

Article 17 

- 

Article 17(1) and (2) 

Article 17(3) 

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Article 18(1) to (3) 

Article 18(1) to (3) 

Article 18(1) to (3) 

- 

- 

Article 18(4) and (5) 

Articles 19 and 20 

Articles 19 and 20 

Articles 19 and 20 

Article 21(1) to (4) 

Article 21(1) to (4) 

Article 21(1) to (4) 

Article 21a(1) 

Article 21a(2) 

Article 21b 

Article 21c 

Article 22 

Article 22a 

- 

- 

- 

Article 23 

Article 24 

Article 25 

Article 26 

Article 22 

Article 21a 

- 

Article 21b 

Article 26 

Article 24 

- 

Article 23 

Article 25 

Article 27 

Article 28 

Article 29 

Article 30 

Article 22 

Article 21(5) 

- 

Article 21(6) 

Article 26 

Article 24(1) and (2) 

Article 24(3) 

Article 23 

Article 25 

Article 27 

Article 28 

Article 29 

Article 30 

Annexes I to VII 

Annexes I to VII 

Annexes I to VII 

- 

- 

Annexes VIII to X 

________________ 

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