Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the interoperability of the rail system within the European Union  (Recast)
Date: 2013-01-30
Institutions: European Commission
Subjects: harmonisation of standards, rail transport, technical standard, trans-European network, transport safety

EUROPEAN 
COMMISSION 

Brussels, 30.1.2013  
COM(2013) 30 final 

2013/0015 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the interoperability of the rail system within the European Union  

(Recast) 

(Text with EEA relevance) 

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

EN 

   EN 

 
 
 
 
 
  
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

1.1. 

Recent EU policy developments in the railway field 

In its White Paper ‘Roadmap to a Single European Transport Area — Towards a competitive 
and resource efficient transport system’, adopted on 28 March 2011 (‘2011 White Paper’), the 
Commission announced its vision for the establishment of a Single European Railway Area, 
clarifying  that  this  objective  implies  creating  an  internal  railway  market  where  European 
railway undertakings can provide services free from unnecessary technical and administrative 
barriers. 

Moreover,  the  European  Council  conclusions  of  January  2012  highlight  the  importance  of 
releasing  the  growth-creating  potential  of  a  fully  integrated  Single  Market,  including  as 
regards  network  industries1.  Furthermore,  the  Commission  Communication  on  Action  for 
Stability,  Growth  and  Jobs  adopted  on  30  May  20122  stresses  the  importance  of  a  further 
reduction  in  the  regulatory  burden  and  barriers  to  entry  in  the  rail  sector,  making  country-
specific recommendations in that direction. In the same vein, on 6 June 2012 the Commission 
adopted  the  Communication  on  strengthening  the  governance  of  the  single  market,  which 
likewise stresses the importance of the transport sector3. 

In the last decade, the EU railway market has seen massive changes, gradually introduced by 
three  legislative  ‘railway  packages’  (with  some  accompanying  acts)  intended  to  open  up 
national  markets  and  make  railways  more  competitive  and  interoperable  at  the  EU  level, 
while  maintaining  high  levels  of  safety.  However,  despite  the  considerable  development  of 
the ‘EU acquis’ establishing an internal market for rail transport services, the modal share of 
rail  in  intra-EU  transport  remains  modest.  Thus,  the  Commission  has  planned  to  come 
forward with the fourth railway package in order to enhance the quality and efficiency of rail 
services  by  removing  the  remaining  market  obstacles.  This  Directive  is  a  component  of  the 
fourth  railway  package,  focusing  on  the  removal  of  remaining  administrative  and  technical 
barriers, in particular by: establishing a common approach to safety and interoperability rules 
to  increase  economies  of  scale  for  railway  undertakings  active  across  the  EU;  decreasing 
administrative  costs  and  accelerating  administrative  procedures;  and  by  avoiding  disguised 
discrimination. 

1.2. 

Legal framework for interoperability 

Under the Treaty on the Functioning of the European Union (Articles 170 and 171), the Union 
must contribute to the establishment and development of trans-European networks in the areas 
of transport. In order to achieve these objectives, the Union must take any measures necessary 
to  ensure  the  interoperability  of  the  networks,  particularly  in  the  field  of  technical 
standardisation. 

The initial measures taken in the rail sector were Directive 96/48/EC on the interoperability of 
the  trans-European  high-speed  rail  system  and  Directive  2001/16/EC  on  the  interoperability 
of  the  trans-European  conventional  rail  system,  amended  by  Directive  2004/50/EC.  These 

1 
2 
3 

http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/ec/127599.pdf. 
COM(2012) 299 final. 
COM(2012) 259 final. 

EN 

2 

   EN 

 
                                                 
Directives  were  recast  by  Directive  2008/57/EC  on  the  interoperability  of  the  rail  system 
within the Community, which is currently in force as amended by Directive 2009/131/EC and 
Directive 2011/18/EU. 

1.3.  Why recast interoperability Directive 2008/57/EC as amended? 

Several  lessons  have  been  learned  based  on  the  work  done  on  developing  TSIs,  the 
application of the interoperability Directives to specific projects, the work of the Committee 
set  up  under  Article  29  of  Directive  2008/57/EC  and  feedback  from  stakeholders. 
Furthermore, the legislative context for the marketing of products has evolved in recent years, 
with the result that the interoperability legislation needs to be updated. 

On  this  basis,  the  Commission  intends  to  propose  a  number  of  changes  to  Directive 
2008/57/EC, which can be grouped into three different categories: 

• 

• 

• 

• 

new provisions: a number of new definitions, the concept of a vehicle authorisation 
for placing on the market, and some provisions on registers; 

clarification  of  existing  provisions:  scope  of  the  Directive,  application  of  TSI  to 
existing  systems,  TSI  derogations,  TSI  deficiencies  and  applicability  of  national 
rules; 

updates  due  to  the  evolution  of  the  legislative  framework:  provisions  concerning 
conformity  assessment  and  conformity  assessment  bodies,  as  well  as  references  to 
comitology procedures and delegated acts; 

editorial changes: consolidation of previous amendments to the text of the Directive, 
renumbering  of  articles  and  annexes,  references  to  other  components  of  the  fourth 
railway  package,  targeted  rewording  of  a  few  sentences  to  avoid  translation 
ambiguities. 

2. 

RESULTS  OF  CONSULTATIONS  WITH  INTERESTED  PARTIES  AND 
IMPACT ASSESSMENTS 

The  European  Commission  carried  out  a  thorough  impact  assessment  to  support  legislative 
proposals for improving the efficiency and competitiveness of the Single European Railway 
Area in the field of interoperability and safety. 

An Impact Assessment Steering Group (IASG) was created in June 2011. While all DGs were 
invited by DG MOVE to participate, the DGs most concerned were ENTR, EMPL, SG, SJ, 
HR, RTD, BUDG, REGIO, ENER and ELARG. 

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

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

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

Since  then,  DG  MOVE  has  taken  part  in  bilateral  meetings  with  the  sector  to  gauge  their 
views on what should be done in the fourth railway package with respect to interoperability 
and safety. 

EN 

3 

   EN 

 
Given  the  technical  nature  of  the  initiative,  there  was  no  public  consultation.  However,  the 
Commission made sure that all interested parties were consulted at the appropriate time and 
that the discussions covered all the key elements of the initiative. 

More information on the impact assessment and the results of the stakeholder consultation is 
provided  in  the  Commission  staff  working  document  accompanying  legislative  proposals  to 
eliminate  remaining  administrative  and  technical  barriers  in  the  field  of  interoperability  and 
safety on the EU railway market. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

This section provides comments and explanations relating to significant changes in the text of 
the  Directive.  It  does  not  provide  detailed  comments  on  minor  changes  introduced  as  a 
consequence of the Lisbon Treaty, editorial modifications and other obvious amendments. 

The numbering corresponds to the renumbered articles and annexes, unless preceded by ‘ex’, 
in which case it refers to the numbering as it is in Directive 2008/57/EC. 

CHAPTER I 

Article 1 

The Commission services, together with the committee referred to in Article 29 of Directive 
2008/57/EC,  had  already  addressed  in  February  2009  the  clarification  of  the  scope  of  the 
Directive  as  far  as  lines  and  vehicles  used  for  local,  urban  and  suburban  services  were 
concerned.  The  conclusion  of  this  analysis  was a  three-fold  approach:  i)  exclusion  of  urban 
rail  and  clarification  of  the  scope;  ii) development  of  a  dedicated  urban  rail  European 
voluntary standardisation framework; and iii) development of essential requirements for urban 
transport. 

The first action was initiated in October 2009, when the Commission services invited Member 
States to exclude from the scope of the measures transposing Directive 2008/57/EC cases (a) 
and (b) as defined in its Article 1(3). This was to avoid a situation in which a Member State 
might apply the Directive to de facto cases not covered by the TSIs. Such a situation would in 
fact  imply  that  Member  States  notify  all  national  rules  in  use  for  metro,  tram  and  light  rail 
systems in the absence of TSIs and follow for these systems all the procedures set out by the 
Directive for heavy rail, which would amount to a disproportionate administrative, technical 
and legal burden. To avoid this situation, the proposed amendment formalises in paragraph 3 
the indication already given by the Commission services in October 2009, thus completing the 
first action. 

The  second  action  was  formally  initiated  in  February  2011,  when  the  Commission  issued  a 
mandate addressed to the European standardisation bodies to develop voluntary standards in 
urban rail. 

To  contribute  to  the  abovementioned  third  action,  in  October  2011  the  associations 
representing the urban rail sector issued a set of ‘fundamental requirements’, which are being 
used  as  basic  references  for  the  execution  of  the  urban  rail  standardisation  programme 
proposed by CEN/CENELEC and ETSI in October 2011. 

On  this  basis,  interoperability  for  local,  urban  and  suburban  systems  is  considered  to  be 
adequately addressed in the voluntary field and does not need to be covered by this Directive. 

Article 2 

For  the  sake  of  clarity,  and  to  take  account  of  the  evolution  of  the  legal  framework,  some 
definitions have been reworded or added. 

EN 

4 

   EN 

 
Ex Article 3 

It has been deleted because redundant with Article 1. 

Article 3 

No substantial change. 

CHAPTER II 

Article 4 

Further provisions are to be specified in the TSIs to cover existing subsystems and to enable 
railway  undertakings  to  check  compatibility  between  vehicles  and  routes  on  which  these 
vehicles are intended to be operated. 

Article 5 

No substantial change, apart from those required by the Lisbon Treaty. 

Article 6 

This  clarifies  the  use  of  Agency  opinions  pending  the  amendment  of  TSIs  as  a  result  of 
deficiencies discovered. 

Ex Article 7 

This article has been deleted because it has become obsolete. In fact, the TSIs will have been 
extended by the time this Directive enters into force. 

Article 7 

The cases of possible non-application of TSIs have been reduced because case 1(b) of Article 
9 of the current Directive is unclear, has never been used and could be covered, as in cases 
1(c) and 1(f), by specific cases in TSIs. 

Articles 8, 9 and 10 

No substantial change, apart from those required by the Lisbon Treaty. 

Ex Article 12 

Deleted because covered by Directive 1025/2012/EU. 

Article 11 

No substantial change. 

CHAPTER IV 

Ex Article 15 

Its provisions are transferred to articles in Chapter V. 

Article 12 

No substantial change. 

Articles 13 and 14 

These articles have been reworded for consistency with the revised text of this Directive and 
for consistency with the Agency Regulation and the Safety Directive. They clarify the role of 
national  rules,  the  cases  in  which  national  rules  may  be  introduced,  and  the  procedures  for 
their withdrawal and their publication. 

EN 

5 

   EN 

 
The Agency retains its tasks concerning the classification of national rules (ex Article 27); in 
addition, the Agency shall examine notified national rules and invite Member States to repeal 
them in case of redundancy or incompatibility with the EU legislation. 

Article 15 

It clarifies the circumstances which trigger a new EC declaration of verification. 

Article 16 

No substantial change. 

Article 17 

It  recalls  the  general  principle  of  presumption  of  conformity  set  out  in  Directive 
1025/2012/EU. 

Ex Article 20 

Some of the content has been clarified and transferred to Chapter V. The remaining content is 
already covered by Article 7 (non-application of TSIs). 

CHAPTER V 

Ex Articles 21 to 25 have been deleted and replaced with new articles 18 to 20. 

Article 18 

For  fixed  installations  the  procedure  is  practically  identical  to  that  of  Directive  2008/57, 
except for trackside control-command and signalling subsystems, which will be authorised by 
the Agency for consistency with the corresponding on-board subsystems. 

Article 19 

It  addresses  the  placing  on  the  market  of  mobile  subsystems,  which  can  be  done  by  both 
railway  undertakings  and  manufacturers.  In  practice,  mobile  subsystems  are  not  placed  in 
service individually; their placing in service is done when they are integrated in a vehicle, and 
the placing in service of a vehicle is addressed in Article 21. 

Article 20 

It introduces the notion of vehicle authorisation for placing on the market, which is partially 
replacing  the  concept  of  vehicle  authorisation  for  placing  in  service  issued  by  the  national 
safety authority as set out in Directive 2008/57/EC. 

The vehicle authorisation for placing on the market is issued by the Agency and contains all 
information needed later by the railway undertaking to place a vehicle in commercial service. 
The applicant (railway undertaking, manufacturer, etc.) may ask the Agency to complement 
the vehicle authorisation for placing on the market with a statement concerning the technical 
compatibility of the vehicle with a particular set of lines or networks defined by the applicant 
on  the  basis  of  commercial  and/or  technical  considerations.  This  complementary  statement 
will facilitate the railway undertaking in its task of placing the vehicle in service. 

EN 

6 

   EN 

 
Article 21 

It  clarifies  the  role  of  railway  undertakings  and  infrastructure  managers  in  checking  the 
technical compatibility of the vehicle with the route and the safe integration of the vehicle in 
the system in which it is intended to operate. 

Article 22 

It  concerns  the  authorisation  for  placing  on  the  market  for  types  of  vehicles  and  has  been 
amended to reflect the provisions of Articles 18 to 21. 

ex Article 27 

It  has  been  deleted  because  some  of  its  provisions  have  been  transferred  to  the  Agency 
Regulation. 

CHAPTER VI 

Articles  23  to  41  concerning  conformity  assessment  bodies  replace  and  complement  ex 
Article 28 and ex Annex VIII to include the provisions of the new legislative framework for 
the marketing of products as defined in Decision 768/2008/EC. 

Ex Article 31 

This article has been deleted because it is obsolete. 

CHAPTER VII 

Articles  42  to  45  on  EVN  and  registers  have  been  updated  to  reflect  the  provisions  of 
Chapter V. 

Ex Article 36 

This article has been deleted because it is obsolete. 

CHAPTER VIII 

Articles 46 and 47 

These articles concern the delegation of powers to the Commission under the Lisbon Treaty. 

Article 48 

It has been modified to take into account the new comitology procedures. 

Ex Article 30 

This article has been deleted because it is obsolete. 

Articles 49 and 50 

These articles have been updated for consistency with the text of this Directive. 

Article 51 

It includes the new provisions with respect to the transitional regime for placing in service of 
vehicles. This will enable the parallel application of both regimes (Directive 2008/57/EC and 
this Directive) for a limited period. 

Article 52 

As  a  consequence  of  the  Lisbon  Treaty,  a  number  of  Annexes  to  Directive  2008/57/EC  are 
transformed into implementing acts to be adopted by the Commission. This article sets out the 
provisions to be applied until the date of application of those implementing acts. 

Articles 53 

EN 

7 

   EN 

 
It  provides  for  correspondence  tables  to  be  communicated  by  Member  States  when 
transposing  this  Directive  into  national  legislation.  These  tables  are  needed  because  of  the 
substantial  changes  introduced  by  this  Directive  in  Chapters  V  and  VI  and  are  considered 
necessary to enable all actors to easily identify the national legislation applicable. 

Article 54 

New article concerning the role of Agency opinions and recommendations. 

Articles 55 to 57 

They have been updated for consistency with the text of this Directive. 

Annex I 

There is no longer any mention of the trans-European rail system because the TSIs will have 
been extended de facto by the time this Directive enters into force. 

The separation between high-speed (HS) and conventional rail (CR) has also been removed in 
view of the merging of a number of HS and CR TSIs. 

Taking account of the above, the classification of vehicles has been simplified. 

Annexes II and III 

No substantial change. 

Ex Annex IV 

It is transformed into an implementing act, see Article 8(2). 

Ex Annexes V and VI 

They are transformed into implementing acts, see Article 15(7). 

Ex Annex VII 

It is transformed into an implementing act, see Article 14(8). 

Ex Annex VIII 

This article has been deleted because it is included in Articles 27, 28 and 29. 

Ex Annex IX 

It is transformed into an implementing act, see Article 7(3). 

Annexes IV and V 

They have been updated for consistency with the text of this Directive. 

EN 

8 

   EN 

 
(cid:208) 2008/57/EC (adapted) 

2013/0015 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the interoperability of the rail system within the European Union  

(Recast) 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union establishing  the 
European  Community,  and  in  particular  Articles  71  and  156  ⌦ 91(1),  170  and  171 ⌫ 
thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments, 
Having regard to the opinion of the European Economic and Social Committee1, 
Having regard to the opinion of the Committee of the Regions2, 

Acting in accordance with the ordinary legislative procedure,  

Whereas: 

(cid:208) 2008/57/EC recital 1 (adapted) 

Council  Directive  96/48/EC  of  23 July  1996on  the  interoperability  of  the  trans-European 
high-speed  rail  system3  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 
system4 were substantially amended by Directive 2004/50/EC of the European Parliament and 
of the Council5. As new amendments are now being introduced, it is appropriate to recast the 
Directives for the sake of clarity and merge their provisions together into a single instrument 
with a view to simplification. 

1 
2 
3 

4 
5 

OJ C , , p. . 
OJ C , , p. . 
OJ L 235, 17.9.1996, p. 6. Directive as last amended by Commission Directive 2007/32/EC (OJ L 141, 
2.6.2007, p. 63). 
OJ L 110, 20.4.2001, p. 1. Directive as last amended by Directive 2007/32/EC. 
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  system  (OJ  L 164,  30.4.2004,  p. 114.  Corrected  by  OJ  L 220, 
21.6.2004, p. 40). 

EN 

9 

   EN 

 
 
 
                                                 
(1) 

(2) 

(3) 

(cid:216) new 

Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 
on the interoperability of the rail system within the Community6 has been substantially 
amended  several  times.  Since  further  amendments  are  to  be  made,  that  Directive 
should be recast in the interests of clarity. 

(cid:208) 2008/57/EC recital 2 (adapted) 

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. 

(cid:216) new 

The  pursuit  of  interoperability  within  the  Union's  rail  system  should  lead  to  the 
definition  of  an  optimal  level  of  technical  harmonisation  and  make  it  possible  to 
facilitate,  improve  and  develop  international  rail  transport  services  within  the  Union 
and  with  third  countries  and  contribute  to  the  progressive  creation  of  the  internal 
market  in  equipment  and  services  for  the  construction,  renewal,  upgrading  and 
operation of the rail system within the Union. 

By  signing  the  Protocol  adopted  in  Kyoto  on  12 December  1997  the  European  Union  has 
undertaken to reduce its greenhouse 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) 2008/57/EC recital 3 (adapted) 

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

(cid:208) 2008/57/EC recital 43 (adapted) 

(cid:208) 2008/57/EC recital 5 

(4) 

The commercial operation of trains throughout the rail network requires in particular 
excellent  compatibility  between  the  characteristics  of  the  infrastructure  and  those  of 
the  vehicles,  as  well  as  efficient 
information  and 
communication  systems  of  the  different  infrastructure  managers  and  railway 
undertakings. Performance levels, safety, quality of service and cost depend upon such 

interconnection  of 

the 

6 

OJ L 191, 18.7.2008, p. 1. 

EN 

10 

   EN 

 
 
 
 
 
 
 
                                                 
compatibility and interconnection, as does, in particular, the interoperability of the rail 
system. 

(cid:208) 2008/57/EC recital 6 (adapted) 
(cid:214) new 

(5)  Member States are responsible (cid:214) The railway regulatory framework should set clear 
responsibilities   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) 2008/57/EC recital 7 (adapted) 

(6) 

There  are  major  differences  between  the  national  regulations,  and  between  internal 
rules  and  technical  specifications  which  the  railways  apply  ⌦ applicable  to  rail 
systems, subsystems  and components ⌫ , 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 ⌦ Union ⌫ network. 

(cid:208) 2008/57/EC recital 8 (adapted) 
(cid:214) new 

(7) 

Over the years, this situation has created very close links between the national railway 
industries and the national railways, to the detriment of the ⌦ a ⌫ genuine opening-
up  of  markets  (cid:214) allowing  new  entrants  to  emerge .  In  order  to  enhance  their 
competitiveness at world level, these industries require an open, competitive European 
market. 

(cid:208) 2008/57/EC recital 9 (adapted) 
(cid:214) new 

(8) 

It  is  therefore  appropriate  to  define  basic  essential  requirements  (cid:214) related  to  rail 
interoperability   for  the  whole  of  the  Community  ⌦ Union ⌫  which  will 
⌦ should ⌫ apply to its rail system. 

To achieve these objectives an initial measure was taken by the Council on 23 July 1996 with 
the adoption of Directive 96/48/EC. The European Parliament and the Council subsequently 
adopted Directive 2001/16/EC. 

(cid:208) 2008/57/EC recital 10 

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  railways7,  2001/13/EC  of  the  European  Parliament  and  of  the  Council  of 

(cid:208) 2008/57/EC recital 11 

7 

OJ L 75, 15.3.2001, p. 1. 

EN 

11 

   EN 

 
 
 
 
 
 
 
                                                 
26 February  2001  amending  Council  Directive  95/18/EC  on  the  licensing  of  railway 
undertakings8 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 certification9 has had 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) 2008/57/EC recital 12 (adapted) 
(cid:214) new 

(9) 

The development of technical specifications for interoperability (TSIs) has shown the 
need to clarify the relationship between the essential requirements 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 ⌦ should ⌫ be made mandatory in order to achieve 
the  objectives  of  this  Directive,  and  the  "harmonised  standards"  that  have  been 
developed  (cid:214) in  accordance  with  Regulation  (EU)  No  1025/2012  of  the  European 
Parliament  and  of  the  Council  of  25  October  2012  on  European  standardisation, 
amending  Council  Directives  89/686/EEC  and  93/15/EEC  and  Directives  94/9/EC, 
94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 
2009/105/EC  of  the  European  Parliament  and  of  the  Council  and  repealing  Council 
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and 
of  the  Council10   in  the  spirit  of  the  new  approach  to  technical  harmonisation  and 
standardisation. (cid:214) Where strictly necessary, the TSIs may make an explicit reference 
to  European  standards  or  specifications,  which  become  mandatory  from  the  moment 
the TSI is applicable.   

(cid:216) new 

(10) 

In order to genuinely increase the competitiveness of the Union railway sector without 
distorting  competition  between  key  actors  of  the  rail  system,  the  TSIs,  should  be 
drafted  by  respecting  the  principles  of  openness,  consensus  and  transparency  as 
defined in Annex II to Regulation (EU) No 1025/2012. 

(11)  The quality of rail services in the Union depends, inter alia, on excellent compatibility 
between  the  characteristics  of  the  network  in  the  broadest  sense,  including  the  fixed 
parts of all the subsystems concerned and those of the vehicles including the onboard 
components  of  all  the  subsystems  concerned.  Performance  levels,  safety,  quality  of 
service and cost depend upon that compatibility. 

8 
9 

10 

OJ L 75, 15.3.2001, p. 26. 
OJ L 75, 15.3.2001, p. 29. Directive as last amended by Commission Directive 2007/58/EC (OJ L 315, 
3.12.2007, p. 44). 
OJ L 316, 14.11.2012, p. 12. 

EN 

12 

   EN 

 
 
 
                                                 
(cid:208) 2008/57/EC recital 13 

As a rule, 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  this  Directive,  particularly  in  the  case  of  interoperability 
constituents and 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. 

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. 

(cid:208) 2008/57/EC recital 14 

(cid:208) 2008/57/EC recital 15 (adapted) 

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

(cid:208) 2008/57/EC recital 16 (adapted) 

(13)  When developing new TSIs the aim should always be to ensure compatibility with the 
existing  authorised  system.  This  will  help  to  promote  the  competitiveness  of  rail 
transport  and  prevent  unnecessary  additional  costs  through  the  requirement  of 
upgrading  or  renewal  of  existing  authorised  subsystems  to  ensure  backward 
compatibility.  In  those  exceptional  cases  where  it  will  not  be  possible  to  ensure 
compatibility,  TSIs  may  establish  the  framework  necessary  to  decide  whether  the 
existing  subsystem  may  need  to  be  re-authorised  ⌦ needs  a  new  decision  or 
authorisation for placing in service ⌫ , and the corresponding deadlines. 

(cid:208) 2008/57/EC recital 17 (adapted) 

(14) 

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  ⌦ should ⌫  must  be  open  to  consultation  by  all 
Member States and by certain Community economic players ⌦ within the Union ⌫. 
The ⌦ national vehicle ⌫ registers should be consistent as regards the data format. 
They should therefore be covered by common operational and technical specifications. 

EN 

13 

   EN 

 
 
 
 
 
 
(15) 

If  certain  technical  aspects  corresponding  to  the  essential  requirements  cannot  be 
explicitly covered in a TSI, such aspects which need still to be addressed are identified 
in an annex to the TSI as open points. For these open points, pending the completion 
of the TSI, national rules apply. 

(cid:216) new 

(cid:208) 2008/57/EC recital 18 (adapted) 

(16)  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  the  notified  bodies 
referred to in Article 17 20 of Directives 2008/57/EC 96/48/EC and 2001/16/EC. 

(17)  Directive 2008/57/EC applies to the entire rail system within the Union and the scope 
of the TSIs is being extended to cover also the vehicles and networks not included in 
the trans-European rail system. Therefore, Annex I should be simplified by removing 
specific references to the trans-European rail system.  

(cid:216) new 

(cid:208) 2008/57/EC recital 19 

The  distinction  between  a  high-speed  rail  system  and  a  conventional  rail  system  does  not 
warrant  two  separate  directives.  The  procedures  for  developing  TSIs  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  both 
systems. It is therefore appropriate to combine Directives 96/48/EC and 2001/16/EC. 

(cid:216) new 

(18)  The  functional  and  technical  specifications  to  be  met  by  the  subsystems  and  their 
interfaces may vary according to the use of subsystems, for example according to the 
categories of lines and vehicles. 

(19) 

In  order  to  ensure  the  progressive  implementation  of  rail  interoperability  within  the 
whole  Union  and  gradually  reduce  the  diversity  of  legacy  systems,  the  TSIs  should 
specify the provisions to be applied in the event of renewal or upgrading of existing 
subsystems and may specify deadlines for achieving the target system.  

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  enters 

(cid:208) 2008/57/EC recital 20 

EN 

14 

   EN 

 
 
 
 
 
 
 
into force, its scope will cover conventional and high-speed European networks as defined 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 network11, and the 
vehicles likely to travel on those networks. The scope will be progressively extended to the 
whole  network  and  all  vehicles,  provided  that  an  impact  assessment  shows  the  economic 
benefit of so doing. 

(20) 

In view of the gradual approach to eliminating obstacles to the interoperability of the 
rail  system  and  of  the  time  consequently  required  for  the  adoption  of  TSIs,  steps 
should be taken to avoid a situation where Member States adopt new national rules or 
undertake projects that increase the diversity of the present system. 

(cid:208) 2008/57/EC recital 21 

(cid:216) new 

(21) 

In  order  to  eliminate  the  obstacles  to  interoperability,  and  as  a  consequence  of 
extending  the  scope  of  the  TSIs  to  the  whole  Union's  rail  system,  the  amount  of 
national rules should progressively be reduced. National rules should be differentiated 
between  rules  strictly  related  to  local  requirements  and  rules  needed  to  cover  open 
points in TSIs. The second type of rules should progressively be removed as a result of 
closure of open points in the TSIs. 

(22)  The adoption of a gradual approach satisfies the special needs of the objective of the 
interoperability of the rail system, which is characterised by old national infrastructure 
and vehicles 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. 

(cid:208) 2008/57/EC recital 22 

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

(cid:208) 2008/57/EC recital 23 

(cid:208) 2008/57/EC recital 24 

The Council, at its 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  and  training  and 
qualifications of the staff concerned. 

11 

OJ  L 228,  9.9.1996,  p. 1.  Directive  as  last  amended  by  Council  Regulation  (EC)  No 1791/2006  (OJ 
L 363, 20.12.2006, p. 1). 

EN 

15 

   EN 

 
 
 
 
 
 
                                                 
(cid:208) 2008/57/EC recital 26 

Pursuant  to  Council  Directive  91/440/EEC  of  29 July  1991  on  the  development  of  the 
Community's  railways12,  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) 2008/57/EC recital 26 (adapted) 

(23) 

the  essential  requirements  must  be  specified  and 

In view of the  extent  and complexity of  the rail system, it has proved necessary, for 
practical  reasons,  to  break  it  down  into  the  following  subsystems:  infrastructure, 
⌦ trackside ⌫ control-command and signalling, ⌦ on-board control-command and 
signalling, ⌫  energy,  rolling  stock,  operation  and  traffic  management,  maintenance 
and  telematics  applications  for  passenger  and  freight  services.  For  each  of  these 
subsystems 
technical 
specifications  determined  for  the  whole  of  the  Community, particularly in respect of 
constituents  and  interfaces,  in  order  to  meet  these  essential  requirements.  The  same 
system is broken down into fixed and mobile elements comprising, on the one hand, 
the  network,  composed  of  the  lines,  stations,  terminals,  and  all  kinds  of  fixed 
equipment needed to ensure safe and continuous operation of the system and, on the 
other hand, all vehicles travelling on this network. Therefore, for the purposes of this 
Directive,  a  vehicle  is  composed  of  one  subsystem  (rolling  stock)  and  where 
applicable  one  or  more  parts  of  other  subsystems  (mainly  the  on-board  part  of  the 
control-command  and  signalling  subsystemand  the  onboard  part  of  the  energy 
subsystem). 

the 

(cid:216) new 

(24)  The  United  Nations  Convention  on  the  Rights  of  Persons  with  Disabilities  to  which 
the  Union  is  a  party  establishes  accessibility  as  one  of  its  general  principles  and 
requires  States  Parties  to  take  appropriate  measures  to  ensure  to  persons  with 
disabilities  access  on  an  equal  basis  with  others,  including  by  developing, 
promulgating  and  monitoring  the  implementation  of  minimum  standards  and 
guidelines for accessibility. Accessibility is therefore an important requirement for the 
interoperability of the rail system. 

(25) 

Implementation of the provisions on the interoperability of the 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  ⌦ should ⌫  endeavour  to  retain  the 
objective of interoperability. 

(cid:208) 2008/57/EC recital 27 (adapted) 

12 

OJ L 237, 24.8.1991, p. 25. Directive as last amended by Directive 2007/58/EC. 

EN 

16 

   EN 

 
 
 
 
 
                                                 
(26)  TSIs 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) 2008/57/EC recital 28 

(cid:208) 2008/57/EC recital 29 
(cid:214) new 

(27)  Each  Member  State  concerned  should  be  allowed  not  to  apply  certain  TSIs  in  (cid:214) a 
limited number of duly substantiated situations. These situations and the procedures to 
be followed in case of non-application of the TSI should be clearly defined  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. 

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

(cid:208) 2008/57/EC recital 30 

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

(cid:208) 2008/57/EC recital 31 

(cid:208) 2008/57/EC recital 32 (adapted) 

(29)  To  comply  with  the  appropriate  provisions  on  procurement  procedures  in  the  rail 
sector and in particular Directive 2004/17/EC of the European Parliament and of the 
Council of  31 March  2004  coordinating  the  procurement  procedures  of  entities 
operating in the water, energy, transport and postal services13, 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 ⌦ set of rules 
⌫ body of European specifications in order to serve as references for these technical 
specifications. 

(30)  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 ⌦ the Union ⌫ policy would be in the Community’s ⌦ Union’s ⌫ 

(cid:208) 2008/57/EC recital 33 (adapted) 

13 

Directive 2004/17/EC of  the European  Parliament  and of  the  Council of 31 March 2004  coordinating 
the  procurement  procedures  of  entities  operating  in  the  water,  energy,  transport  and  postal  services 
sectors  (OJ  L 134,  30.4.2004,  p. 1).  Directive  as  last  amended  by  Commission  Regulation  (EC) 
No 213/2008 (OJ L 74, 15.3.2008, p. 1). 

EN 

17 

   EN 

 
 
 
 
 
 
 
                                                 
interest.  The  European  standardisation  ⌦ organisations ⌫  bodies  ⌦ should ⌫ 
must therefore continue their cooperation with the international standardisation bodies. 

(31)  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 ⌦ Union ⌫  level 
and which the rail system must satisfy. 

(cid:208) 2008/57/EC recital 34 (adapted) 

(cid:208) 2008/57/EC recital 35 

(32)  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 Council Decision 
93/465/EEC14  Commission  Decision  2010/713/EU  of  9  November  2010  on  modules 
for the procedures for assessment of conformity, suitability for use and EC verification 
to be used in the technical specifications for interoperability adopted under Directive 
2008/57/EC of the European Parliament and of the Council15. 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) 2008/57/EC recital 36 (adapted) 

(33)  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  ⌦ Union ⌫  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  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. 

(34)  Manufacturers are nonetheless obliged to affix the CE marking to certain components 
in  order  to  certify  their  compliance  with  other  Community  ⌦ Union ⌫  provisions 
relating to them. 

(cid:208) 2008/57/EC recital 37 (adapted) 

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

(cid:208) 2008/57/EC recital 38 

14 

15 

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). 
OJ L 319, 4.12.2010, pp. 1–52 . 

EN 

18 

   EN 

 
 
 
 
 
 
                                                 
(cid:208) 2008/57/EC recital 39 (adapted) 

(36)  The  subsystems  constituting  the  rail  system  should  be  subjected  to  a  verification 
procedure. This verification must ⌦ should ⌫ enable the authorities ⌦ entities ⌫ 
responsible  for  authorising  their  placing  in  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  ⌦ should ⌫  also  enable 
manufacturers  to  be  able  to  count  upon  equality  of  treatment  whatever  the  country 
⌦ Member  State ⌫  .  It  is  therefore  necessary  to  lay  down  one  or  more  modules 
defining the principles and conditions applying to 'EC' verification of subsystems. 

(cid:208) 2008/57/EC recital 40 
(cid:214) new 

(37)  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 Directive […/…] 2004/49/EC of the European Parliament and of the Council of 
29 April  2004  on  safety  on  the  Community  railways16  [Railway  Safety  Directive]17, 
responsibility  for  meeting  these  requirements  lies,  for  their  respective  subsystems, 
with the infrastructure manager or the railway undertaking. 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. 

(cid:208) 2008/57/EC recital 41 (adapted) 
(cid:214) new 

(38)  As far as vehicles are concerned, The procedure for placing in service (cid:214) of vehicles 
and fixed installations  should be clarified taking into account the (cid:214) responsibilities 
of infrastructure managers and railway undertakings  definition of vehicle which is 
composed  of  one  or  more  subsystems.  In  addition,  as  Directives  96/48/EC  and 
2001/16/EC deal with new and upgraded subsystems and Directive 2004/49/EC deals 
with  in-use  vehicles,  all  provisions  regarding  authorisations  for  placing  in  service  of 
vehicles  should  be  integrated  in  this  Directive.  Furthermore,  a  procedure  for 
authorisation of vehicle types should be added. In order to facilitate this procedure and 
help identify vehicle types, a European register of authorised types of vehicles should 
be set up and maintained by the European Railway Agency (hereinafter referred to as 
the Agency). 

(39)  ⌦ In  order ⌫  with  a  view  to ⌦ facilitate ⌫  facilitating  the  placing  in  service  of 
vehicles and reduce administrative burdens, (cid:214) the notion of a vehicle authorisation for 
placing  on  the  market  valid  throughout  the  Union  should  be  introduced  as  a 
precondition to enable railway undertakings to place in service a vehicle. In addition, 
this notion is more in line with Decision No 768/2008/EC of the European Parliament 
and  of  the  Council  of  9  July  2008  on  a  common  framework  for  the  marketing  of 
products, and repealing Council Decision 93/465/EEC18  . 

16 
17 
18 

OJ L 164, 30.4.2004, p. 44. Corrected by OJ L 220, 21.6.2004, p. 16. 
OJ L...  
OJ L 218, 13.8.2008, p. 82. 

EN 

19 

   EN 

 
 
 
 
                                                 
(cid:216) new 

(40)  To  ensure  traceability  of  the  vehicles  and  their  history,  the  references  of  the  vehicle 
authorisations  for  placing  on  the  market  should  be  recorded  together  with  the  other 
vehicle data. 

(41)  The  TSIs  should  specify  the  procedures  for  checking  the  compatibility  between 
vehicles and network after the delivery of the vehicle authorisation for placing on the 
market and before the decision to place into service. 

(cid:208) 2008/57/EC recital 42 

Experience has shown that the implementation of such a procedure at national level is often 
complicated  and  subject  to  different  national  requirements  that  lack  transparency,  or  even 
duplicate each other. Consequently, this procedure poses a major obstacle to the creation of 
new railway undertakings, particularly in the freight sector. Steps should therefore be taken to 
clarify and simplify the procedures for authorising vehicles. Firstly, the general principle that 
one authorisation is sufficient for the whole Community rail network should be established. 
Secondly,  the  procedure  for  authorising  vehicles  which  are  TSI  conform  should  be  simpler 
and quicker than in the case of non-TSI conform. Thirdly, the principle of mutual recognition 
should be applied as far as possible: when a vehicle has already been placed in service in one 
Member States, other Member States should not invoke national rules to impose unnecessary 
requirements and redundant verifications, unless these are strictly necessary for verifying the 
technical  compatibility  of  the  vehicle  with  the  relevant  network.  To  this  end  national  rules 
should  be  classified  and  compared  according  to  a  check-list  in  order  to  determine  to  which 
extent national rules can be declared as equivalent in terms of requirements, performances and 
safety.  Fourthly,  the  principle  of  legal  certainty  as  regards  the  outcome  of  the  procedure 
should  be  pursued.  To  this  end,  in  the  absence  of  a  decision  of  a  national  safety  authority 
within  the  prescribed  time  limits  an  applicant  should  be  authorised  to  place  in  service  a 
vehicle.  Such  an  authorisation  would  only  be  possible  if  the  vehicle  has  already  been 
authorised  in  another  Member  State.  In  addition,  it  would  only  be  possible  for  a  railway 
undertaking  or  an  infrastructure  manager  duly  certified  in  accordance  with  Directive 
2004/49/EC to use such a vehicle under their full responsibility. 

(42)  To  help  railway  undertakings  decide  on  the  placing  into  service  of  a  vehicle  and  to 
avoid  redundant  verifications  and  unnecessary  administrative  burden,  national  rules 
should  also  be  classified  to  establish  the  equivalence  between  national  rules  of 
different Member States covering the same topics. 

(cid:216) new 

(cid:208) 2008/57/EC recital 43 

The  authorisation  procedures  for  TSI  conform  and  non-TSI  conform  vehicles  are  different. 
There may be cases where the choice of the procedure is not straightforward. Vehicles which 
come  within  the  scope  of  TSI  conform  vehicles  should  be  those  vehicles  where  all  the 
relevant TSIs have entered into force, including at least the TSI on rolling stock. This would 
mean  that  a  significant  part  of  the  essential requirements  has  been  laid  down.  For  example, 
until such time that the conventional TSI on locomotives has entered into force, locomotives 

EN 

20 

   EN 

 
 
 
 
 
fall  within  scope  of  non-TSI  conform  vehicles,  even  though  they  might  comply  with  other 
relevant TSIs in force at the time of their placing in service. 

(cid:208) 2008/57/EC recital 44 

If  certain  technical  aspects  corresponding  to  the  essential  requirements  cannot  be  explicitly 
covered  in  a  TSI,  they  are  identified  in  an  annex  to  the  TSI  as  open  points.  When  a  TSI 
conform vehicle has already been authorised in one Member State, additional authorisations 
should  only  consider  those  open  points  that  relate  to  technical  compatibility  between  the 
vehicle and the network. 

(cid:208) 2008/57/EC recital 45 

The  list  of  parameters  to  be  checked  in  conjunction  with  the  placing  in  service  of  non-TSI 
conform vehicles is a key element for the achievement of interoperability of railway systems, 
in particular with regard to existing vehicles. This list takes into account experience across a 
limited number of networks. Therefore it is necessary that the Agency review the parameters 
in Annex VII and make the recommendations it considers appropriate to the Commission. 

(cid:208) 2008/57/EC recital 46 (adapted) 

(43)  The 'EC' verification procedure should be based on TSIs. These TSIs are subject to the 
provisions  of  Article 18 34  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 
⌦ should ⌫ , in particular in the absence of any European specification, coordinate 
their decisions as closely as possible. 

The  notified  bodies  should  be  structured  in  such  a  way  as  to  meet  the  criteria  which  must 
apply to this type of body in all sectors of the new approach to technical harmonisation and 
conformity verification, especially criteria relating to independence and competence. 

(cid:208) 2008/57/EC recital 47 

(cid:216) new 

(44)  Transparent  accreditation  as  provided  for  in  Regulation  (EC)  No  765/2008  of  the 
European  Parliament  and  of  the  Council  of  9  July  2008  setting  out  the  requirements 
for  accreditation  and  market  surveillance  relating  to  the  marketing  of  products  and 
repealing Regulation (EEC) No 339/9319, ensuring the necessary level of confidence in 
conformity  certificates,  should  be  considered  by  the  national  public  authorities 
throughout the Union the preferred means of demonstrating the technical competence 
of notified and, mutatis mutandis, the bodies designated to check the compliance with 
national  rules.  However,  national  authorities  may  consider  that  they  possess  the 
appropriate means of carrying out this evaluation themselves. In such cases, in order to 
ensure the appropriate level of credibility of evaluations carried out by other national 
authorities, they should provide the Commission and the other Member States with the 

19 

OJ L 218, 13.8.2008, p. 30. 

EN 

21 

   EN 

 
 
 
 
 
 
                                                 
necessary  documentary  evidence  demonstrating  the  compliance  of  the  conformity 
assessment bodies evaluated with the relevant regulatory requirements. 

(45)  This  Directive  should  be  limited  to  establishing  the  interoperability  requirements  for 
interoperability  constituents  and  subsystems.  In  order  to  facilitate  compliance  with 
those  requirements  it  is  necessary  to  provide  for  presumption  of  conformity  for 
interoperability constituents and subsystems which are in conformity with harmonised 
standards that are adopted in accordance with Regulation (EU) No 1025/2012 for the 
purpose of expressing detailed technical specifications of those requirements. 

(cid:208) 2008/57/EC recital 48 (adapted) 
(cid:214) new 

(46)  ⌦ The ⌫  TSIs  will  ⌦ should ⌫  be  revised  at  regular  intervals.  When  errors 
⌦ deficiencies ⌫  are  discovered  (cid:214) in  the  TSIs,  the  European  Union  Agency  for 
Railways (hereinafter referred to as the Agency) should be asked to issue an opinion 
which,  under  certain  conditions,  might  be  published  and  used  by  all  stakeholders 
(including  industry  and  notified  bodies)  as  an  acceptable  means  of  compliance 
pending the revision of the TSIs concerned.  an ad hoc rapid procedure should be set 
up  in  such  a  way  that  a  provisional  corrigendum  is  first  agreed  in  the  context  of  a 
committee  and  then  published  by  the  Agency.  This  will  allow  an  earlier  use  of  this 
corrigendum  by  all  stakeholders,  including  industry,  notified  bodies  and  authorities, 
pending a formal revision of the TSI by the Commission. In order to avoid confusion 
with  official  corrigenda  of  the  Commission,  the  term  technical  opinion  will  be  used. 
This procedure is in line with the mandate adopted by the Commission in Decision of 
13 July 2007 concerning a framework mandate to the European Railway Agency for 
the  performance  of  certain  activities  under  Directives  96/48/EC  and  2001/16/EC. 
However, if the TSI needs to be amended because of an important or critical error, a 
revision procedure should be applied. 

(cid:208) 2008/57/EC recital 49  

The definition of the keeper should be as close as possible to the definition used in the 1999 
Convention  concerning  International  Carriage  by  Rail  (COTIF).  Many  entities  can  be 
identified as a keeper of a vehicle, such as the owner, a company carrying on a business with 
a fleet of wagons, a company leasing vehicles to a railway undertaking, a railway undertaking 
or  an  infrastructure  manager  using  vehicles  for  maintaining  its  infrastructure.  These  entities 
have  control  over  the  vehicle  with  a  view  to  its  use  as  a  means  of  transport  by  the  railway 
undertakings and the infrastructure managers. In order to avoid any doubt, the keeper should 
be clearly identified in the national vehicle registers. 

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 Commission20. 

(cid:208) 2008/57/EC recital 50 

20 

OJ  L 184,  17.7.1999,  p. 23.  Decision  as  amended  by  Decision  2006/512/EC  (OJ  L 200,  22.7.2006, 
p. 11). 

EN 

22 

   EN 

 
 
 
 
                                                 
(cid:208) 2008/57/EC recital 51 

In particular, the Commission should be empowered to adopt and update the TSIs. Since those 
measures  are  of  general  scope  and  are  designed  to  amend  non-essential  elements  of  this 
Directive,  inter  alia,  by  supplementing  it  with  new  non-essential  elements,  they  must  be 
adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a 
of Decision 1999/468/EC. 

(cid:208) 2008/57/EC recital 52 

When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure 
with scrutiny cannot be complied with, the Commission should be able to apply the urgency 
procedure  provided  for  in  Article 5a(6)  of  Decision  1999/468/EC  for  the  adoption  of 
measures designed to amend non-essential elements of this Directive by supplementing it with 
TSIs or amendments thereto. 

(cid:208) 2008/57/EC recital 53 (adapted) 

(47)  Since the objective of this Directive, namely interoperability within the rail system in 
⌦ on a ⌫ Community ⌦ Union ⌫ -wide scale, cannot be sufficiently achieved by 
the  Member  States  ⌦ acting  alone ⌫  ,  since  no  individual  Member  State  is  in  a 
position  to  take  the  action  needed  in  order  to  achieve  such  interoperability  and  can 
therefore  be  better  achieved  at  Community  ⌦ Union ⌫  level,  the  Community 
⌦ Union ⌫ may adopt measures, in accordance with the principle of subsidiarity as 
set out in Article 5 of the Treaty ⌦ on European Union ⌫ . In accordance with the 
principle  of  proportionality,  as  set  out  in  that  Article,  this  Directive  does  not  go 
beyond what is necessary in order to achieve that objective. 

In  accordance  with  point  34  of  the  Interinstitutional  Agreement  on  better  law-making21, 
Member  States  are  encouraged  to  draw  up,  for  themselves  and  in  the  interests  of  the 
Community,  their  own  tables  illustrating,  as  far  as  possible,  the  correlation  between  this 
Directive and the transposition measures, and to make them public. 

(cid:208) 2008/57/EC recital 54 

(cid:216) new 

(48) 

In order to amend non-essential elements of this Directive, the power to adopt acts in 
accordance with Article 290 of the Treaty on the Functioning of the European Union 
should  be  delegated  to  the  Commission  in  respect  of  the  adaptation  to  technical 
progress of Annex II regarding the breakdown of the rail system into subsystems and 
to the description of these subsystems, the content of the TSIs and the amendments to 
TSIs,  including  those  amendments  needed  to  remedy  TSIs  deficiencies.  It  is  of 
particular importance that the Commission carry out appropriate consultations during 
its preparatory work, including at expert level. The Commission, when preparing and 

21 

OJ C 321, 31.12.2003, p. 1. 

EN 

23 

   EN 

 
 
 
 
 
 
                                                 
(49) 

(50) 

(51) 

drawing-up  delegated  acts,  should  ensure  a  simultaneous,  timely  and  appropriate 
transmission of relevant documents to the European Parliament and Council. 

In order to address the deficiencies discovered in TSIs, the Commission should adopt 
delegated acts amending those TSIs under the urgency procedure. 

In order to ensure the implementation of Article 6(1) of this Directive concerning the 
mandate to the Agency to draft TSIs and their amendments and to make the relevant 
recommendations  to  the  Commission,  implementing  powers  should  be  conferred  on 
the Commission. 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Directive, 
implementing powers should be conferred on the Commission relating to: the content 
of the file which shall accompany the request of non-application of one or more TSIs 
or parts of them, the details, the format and the transmission modalities of that file; the 
scope  and  the  content  of  the  EC  declaration  of  conformity  and  suitability  for  use  of 
interoperability constituents, its format and the details of the information included in 
it; the classification of the notified national rules in different groups with  the aim of 
facilitating  the  compatibility  checks  between  fixed  and  mobile  equipment;  the 
verification  procedures  for  subsystems,  including  the  general  principles,  the  content, 
procedure  and  documents  related  to  the  'EC'  verification  procedure,  and  to  the 
verification  procedure  in  the  case  of  national  rules;  the  templates  for  the  'EC' 
declaration of verification and for the declaration of verification in the case of national 
rules  and  templates  for  documents  of  the  technical  file  that  has  to  accompany  the 
declaration of verification; the common specifications relating to content, data format, 
functional  and  technical  architecture,  operating  mode  and  rules  for  data  input  and 
consultation  for  the  register  of  infrastructure.  Those  powers  should  be  exercised  in 
accordance with Regulation (EU) No 182/2011 of the European Parliament and of the 
Council of 16 February 2011 laying down the rules and general principles concerning 
mechanisms  for  control  by  Member  States  of  the  Commission's  exercise  of 
implementing powers22. 

(52) 

In  accordance  with  the  Joint  Political  Declaration  of  Member  States  and  the 
Commission  on  explanatory  documents  of  28  September  2011,  Member  States  have 
undertaken  to  accompany,  in  justified  cases,  the  notification  of  their  transposition 
measures  with  one  or  more  documents  explaining  the  relationship  between  the 
components  of  a  directive  and  the  corresponding  parts  of  national  transposition 
instruments. With regard to this Directive, the legislator considers the transmission of 
such documents to be justified. 

(53)  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:208) 2008/57/EC recital 55 (adapted) 

22 

OJ L 55, 28.2.2011, p.13. 

EN 

24 

   EN 

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

(cid:216) new 

Article 14  of  Directive  2004/49/EC  and  Directives  96/48/EC  and  2001/16/EC  should 
therefore be repealed. 

(cid:208) 2008/57/EC recital 56 

HAVE ADOPTED THIS DIRECTIVE: 

(cid:208) 2008/57/EC (adapted) 

CHAPTER I 

GENERAL PROVISIONS 

Article 1 

Purpose ⌦ Subject matter ⌫ and scope 

1. This Directive sets out to establish ⌦ establishes ⌫ the conditions to be met to achieve 
interoperability  within  the  Community  ⌦ Union’s ⌫  rail  system  in  a  manner  compatible 
with  the  provisions  of  Directive […/…on  the  safety  of  the  rail  system  within  the  Union] 
2004/49/EC. These conditions concern the design, construction, placing in service, upgrading, 
renewal,  operation  and  maintenance  of  the  parts  of  this  system  as  well  as  the  professional 
qualifications and health and safety conditions of the staff who contribute to its operation and 
maintenance. 

⌦ 2.  This  Directive  lays  down  the  provisions  relating  to,  for  each  subsystem,  the 
interoperability constituents, the interfaces and procedures as well as the conditions of overall 
compatibility of the rail system required to achieve its interoperability. ⌫ 

(cid:208) 2008/57/EC 
(cid:214) new 

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

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

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

(c) contribute to the interoperability of the rail system within the Community. 

3.  Member  States  may  exclude  from  the  measures  they  adopt  in  implementation  (cid:214) The 
following systems are excluded from the scope  of this Directive: 

EN 

25 

   EN 

 
 
 
 
 
 
 
 
(cid:208) 2008/57/EC (adapted) 

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

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

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

(cid:208) 2008/57/EC (adapted) 

(ac)  privately  owned  railway  infrastructure  and  vehicles  exclusively  used  on  such 
infrastructure ⌦ where this  exists ⌫  that  exist  solely  for  use  by  the  owner  for  its 
own freight operations; 

(bd) infrastructure and vehicles reserved for a strictly local, historical or touristic use. 

4. The scope of the TSIs shall be progressively extended in accordance with Article 8 to the 
whole  rail  system,  including  track  access  to  terminals  and  main  port  facilities  serving  or 
potentially serving more than one user, without prejudice to the derogations to the application 
of TSIs as listed in Article 9. 

For the purposes of this Directive: 

Article 2 

Definitions 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

(1) 

(2) 

(3) 

‘trans-  (cid:214) Union   rail  system’  means  the  trans-European  conventional  and  high-
speed  rail  systems  ⌦elements listed ⌫  as  set  out  in  Annex I,  points  1  and  2, 
respectively; 

(cid:208) 2008/57/EC 

‘interoperability’  means  the  ability  of  a  rail  system  to  allow  the  safe  and 
uninterrupted  movement  of  trains  which  accomplish  the  required  levels  of 
performance for these lines. This ability depends on all the regulatory, technical and 
operational  conditions  which  must  be  met  in  order  to  satisfy  the  essential 
requirements; 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

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

EN 

26 

   EN 

 
 
 
 
 
 
 
 
 
 
(4) 

‘network’  means  the  lines,  stations,  terminals,  and  all  kinds  of  fixed  equipment 
needed to ensure safe and continuous operation of the rail system; 

(cid:208) 2008/57/EC 

(5) 

(6) 

(7) 

(8) 

(9) 

(cid:208) 2008/57/EC (adapted) 

‘subsystems’ means the ⌦ structural or functional parts ⌫ result of the division of 
the  rail  system,  as  shown ⌦ set  out ⌫  in  Annex II;  These  subsystems,  for  which 
essential requirements must be laid down, may be structural or functional; 

‘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 
rail  system  depends  directly  or  indirectly,  ⌦ including ⌫  .  The  concept  of  a 
‘constituent’ covers both tangible objects and intangible objects such as software; 

‘essential requirements’ means all the conditions set out in Annex III which must be 
met  by  the  rail  system,  the  subsystems,  and  the  interoperability  constituents, 
including interfaces; 

(cid:208) 2008/57/EC 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

‘European  specification’  means  a  common  technical  specification,  a  European 
technical  approval  ⌦ as  defined  in  Annex XXI  to  Directive  2004/17/EC ⌫  or  a 
national (cid:214) European  standard (cid:214) as defined in Article 2(1)(b) of Regulation (EU) 
No  1025/2012;   transposing  a  European  standard,  as  defined  in  Annex XXI  to 
Directive 2004/17/EC; 

(cid:208) 2008/57/EC 

‘technical  specification  for  interoperability’  (TSI)  means  a  specification  adopted  in 
accordance  with  this  Directive  by  which  each  subsystem  or  part  of  a  subsystem  is 
covered in order to meet the essential requirements and ensure the interoperability of 
the rail system; 

‘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; 

(10) 

‘basic parameters’ means any regulatory, technical or operational condition which is 
critical to interoperability and is specified in the relevant TSIs; 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

EN 

27 

   EN 

 
 
 
 
 
 
 
(11) 

(12) 

(13) 

(14) 

‘specific  case’  means  any  part  of  the  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  ⌦ Union ⌫,  the  loading  gauge,  the  track  gauge  or  space 
between the tracks and vehicles strictly intended for local, regional or historical use, 
as well as vehicles originating from or destined for third countries; 

‘upgrading’ means any  major  modification  work  on  a  subsystem  or  part  subsystem 
⌦ of it ⌫ which (cid:214) results in a change in the technical file accompanying the 'EC' 
declaration  of  verification,  if  this  technical  file  exists,  and  which   improves  the 
overall performance of the subsystem; 

‘renewal’  means  any  major  substitution  work  on  a  subsystem  or  part  subsystem 
⌦ of it ⌫ which does not change the overall performance of thesubsystem; 

‘existing rail system’ means the structure composed of lines and fixed installations of 
the  existing  rail  system  plus  ⌦ as  well  as ⌫  the  vehicles  of  all  categories  and 
origin travelling on that infrastructure; 

(15) 

‘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; 

(cid:208) 2008/57/EC 

(16) 

(17) 

(18) 

(19) 

(cid:208) 2008/57/EC (adapted) 

‘placing in service’ means all the operations by which a subsystem or a vehicle is put 
into its ⌦ operational service ⌫ design operating state; 

‘contracting  entity’  means  any  ⌦ public  or  private ⌫  entity,  whether  public  or 
private, which orders the design and/or construction or the renewal or upgrading of a 
subsystem. This entity may be a railway undertaking, an infrastructure manager or a 
keeper, or ⌦ a ⌫ the concession holder responsible for carrying out a project; 

(cid:208) 2008/57/EC 
(cid:214) new 

‘keeper’ means the person or entity that, being the owner of a vehicle or having the 
right to use it, exploits the vehicle as a means of transport and is registered as such in 
the national vehicle register referred to in Article 4333; 

‘project  at  an  advanced  stage  of  development’  means  any  project  whose 
planning/construction  stage  has  reached  a  point  where  techncal  specifications  exist 
and a change in the technical specifications would (cid:214) may compromise the viability 
of the project as planned;  be unacceptable to the Member State concerned. Such 
legal,  contractual,  economic,  financial,  social  or 
an 
environmental in nature and must be duly substantiated; 

impediment  may  be 

EN 

28 

   EN 

 
 
 
 
(20) 

(21) 

(22) 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

‘harmonised  standard’  means  any  ⌦ a ⌫  European  standard  (cid:214) as  defined  in 
Article 2(1)(c) of Regulation (EU) No 1025/2012  adopted by one of the European 
standardisation  bodies  listed  in  Annex I  to  Directive  98/34/EC  of  the  European 
Parliament  and  of  the  Council  of  22 June  1998  laying  down  a  procedure  for  the 
provision  of  information  in  the  field  of  technical  standards  and  regulations  and  of 
rules  on  Information  Society  services23  in  connection  with  a  mandate  by  the 
Commission drawn up in accordance with the procedure referred to in Article 6(3) of 
that Directive, which, by itself or together with other standards, provides a solution 
as regards compliance with a legal provision; 

‘national  safety  authority’  means  a  safety  authority  as  defined  in  Article  3(g)  of 
Directive  ⌦ …/… 
the 
safety  of 
Union] ⌫ 2004/49/EC; 

system  within 

rail 

[on 

the 

the 

‘type’ means a vehicle type defining the basic design characteristics of the vehicle as 
covered  by  a  ⌦ type  or  design  examination  certificate  described  in  the  relevant 
verification  module ⌫  single  type-examination  certificate  described  in  module B 
of Decision 93/465/EEC; 

(23) 

‘series’ means a number of identical vehicles of a design type; 

‘Agency’  means  the  European  Railway  Agency,  as  established  by  Regulation  (EC) 
No 881/2004  of  the  European  Parliament  and  of  the  Council  of  29 April  2004 
establishing a European railway agency (Agency Regulation)24; 

(cid:208) 2008/57/EC 

(24) 

‘entity  in  charge  of  maintenance’  means  an  entity  in  charge  of  maintenance ⌦ as 
defined in Article 3 of Directive …/…. [Railway Safety Directive] ⌫ of a vehicle, 
and registered as such in the national vehicle register;. 

(cid:208) 2008/57/EC (adapted) 

(cid:216) new 

(25) 

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

(26) 

‘national  rules’  means  all  binding  rules  containing  railway  safety  or  technical 
requirements imposed at Member State level and applicable to railway undertakings, 
irrespective of the body issuing them; 

23 

24 

OJ  L 204,  21.7.1998,  p. 37.  Directive  as  last  amended  by  Council  Directive  2006/96/EC  (OJ  L 363, 
20.12.2006, p. 81). 
OJ L 164, 30.4.2004, p. 1. Corrected by OJ L 220, 21.6.2004, p. 3. 

EN 

29 

   EN 

 
 
 
 
 
                                                 
(27) 

(28) 

(29) 

(30) 

(31) 

(32) 

(33) 

(34) 

(35) 

(36) 

(37) 

(38) 

(39) 

‘design  operating  state’  means  the  normal  operating  mode  and  the  foreseeable 
degraded  conditions  (including  wear)  within  the  range  and  the  conditions  of  use 
specified in the technical and maintenance files; 

‘acceptable means of compliance’ means non-binding opinions issued by the Agency 
to define ways of establishing compliance with the essential requirements; 

‘placing on the market’ means the first making available on the Union’s market of an 
interoperability  constituent,  subsystem  or  vehicle  ready  to  function  in  its  design 
operating state; 

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

‘authorised representative’ means any natural or legal person established within the 
Union who has received a written mandate from a manufacturer to act on his behalf 
in relation to specified tasks; 

‘technical specification’ means a document that prescribes technical requirements to 
be fulfilled by a product, process or service; 

‘accreditation’ has the meaning assigned to it by Regulation (EC) No 765/2008; 

‘national accreditation body’ has the meaning assigned to it by Regulation (EC) No 
765/2008; 

‘conformity  assessment’  means  the  process  demonstrating  whether  specified 
requirements  relating  to  a  product,  process,  service,  system,  person  or  body  have 
been fulfilled; 

‘conformity  assessment  body’  means  a  body  that  performs  conformity  assessment 
activities including calibration, testing, certification and inspection; 

‘disabled person and person with reduced mobility’ shall include any person who has 
a  permanent  or  temporary  physical,  mental,  intellectual  or  sensory  impairment 
which, in interaction with various barriers, may hinder their full and effective use of 
transport  on  an  equal  basis  with  other  passengers  or  whose  mobility  when  using 
transport is reduced due to age. 

‘infrastructure  manager’  means  infrastructure  manager  as  defined  in  Article  3  of 
Directive …/… [establishing a single European railway area];  

‘railway undertaking’ means railway undertaking as defined in Article 3 of Directive 
…/… [establishing a single European railway area], and any other public or private 
undertaking, the activity of which is to provide transport of goods and/or passengers 
by  rail  on  the  basis  that  the  undertaking  must  ensure  traction;  this  also  includes 
undertakings which provide traction only.  

(cid:208) 2008/57/EC 

Article 3 

Overall compatibility 

EN 

30 

   EN 

 
 
1. This Directive concerns the provisions relating to, for each subsystem, the interoperability 
constituents, the interfaces and procedures as well as the conditions of overall compatibility of 
the rail system required to achieve its interoperability. 

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. 

Article 34 

Essential requirements 

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

2. The further technical specifications referred to in Article 34 of Directive 2004/17/EC which 
are  necessary  to  complete  European  specifications  or  other  standards  in  use  within  the 
Community ⌦ Union shall ⌫ must not conflict with the essential requirements. 

(cid:208) 2008/57/EC (adapted) 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

CHAPTER II 

TECHNICAL SPECIFICATIONS FOR INTEROPERABILITY 

Article 45 

Content of TSIs⌦ Technical Specifications for Interoperability ⌫ 

1.  Each  of  the  subsystems ⌦ defined  in  Annex  II ⌫  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  revise  a  TSI  and  the  choice  of  its  technical  and 
geographical scope requires a mandate in accordance with Article 6(1). 

2. The Commission shall be empowered to adopt delegated acts in accordance with Article 46 
concerning adaptation to technical progress of Annex II regarding the breakdown of the rail 
system into subsystems and to the description of these subsystems.  

(cid:216) new 

32.  Subsystems  shall  comply  with  the  TSIs  in  force  at  the  time  of  their  placing  in  service, 
upgrading or renewal, in accordance with this Directive; this compliance shall be permanently 
maintained while each subsystem is in use. 

(cid:208) 2008/57/EC 

EN 

31 

   EN 

 
 
 
 
 
43. To the extent necessary to achieve the objective referred to in Article 1, eEach TSI shall: 

(cid:208) 2008/57/EC (adapted) 

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

(cid:208) 2008/57/EC 

(cid:208) 2008/57/EC (adapted) 

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

(c)  establish  the functional  and technical specifications to  be met  by the subsystem 
and  its  interfaces  vis-à-vis ⌦ in  relation  to ⌫  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 vehicles provided for in Annex I; 

(cid:208) 2008/57/EC 

(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 rail system; 

(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 2010/713/EU25 
93/465/EEC; 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

(f)  indicate  the  strategy  for  implementing  ⌦ the  application  of ⌫  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  (cid:214) including  setting  deadlines  for 
completion of those stages where necessary  ; 

(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 ⌦ application ⌫ of the TSIs. 

25 

OJ L 319, 4.12.2010, p. 1. 

EN 

32 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
(cid:216) new 

(h)  indicate  the  provisions  applicable  to  the  existing  subsystems  and  types  of 
vehicles, in particular in the event of upgrading and renewal, with and without a new 
authorisation or decision for placing in service; 

(i)  indicate  the  parameters  to  be  checked  by  the  railway  undertaking  and  the 
procedures to be applied to check those parameters after the delivery of the vehicle 
authorisation for placing on the market and before the decision for placing in service 
to ensure the compatibility between vehicles and routes on which they are intended 
to be operated; 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

54. 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  ⌦  with them  shall 
facilitate ⌫  therewith  will  help  gradually  (cid:214) within  that  time-scale   to  achieve  the 
interoperability of the rail system. 

65. 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 
TSI, with regard to both network and vehicles, (cid:214) and in particular for  ; special attention 
must be given to the loading gauge, the track gauge or space between the tracks and vehicles 
originating from or destined for third countries. For each specific case, the TSIs shall stipulate 
the  implementing  rules  of  the  elements  of  the  TSIs  indicated  ⌦ provided  for ⌫  in 
paragraph 43(c) to (g). 

76.  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  as  open 
points. Article 17(3) shall apply to these aspects. 

(cid:208) 2008/57/EC 

(cid:208) 2008/57/EC (adapted) 

87.  TSIs  shall  not  ⌦ prevent ⌫  be  an  impediment  to  decisions  by  the  Member  States 
concerning⌦ from  deciding  on ⌫  the  use  of  infrastructures  for  the  movement  of  vehicles 
not covered by the TSIs. 

98.  TSIs  may  make  an  explicit,  clearly  identified  reference  to  European  or  international 
standards  or  specifications  or  technical  documents  published  by  the  Agency  where  this  is 
strictly  necessary  in  order  to  achieve  the  objective  of  this  Directive.  In  such  case,  these 
standards or specifications (or their relevant parts) or technical documents shall be regarded as 
annexes  to  the  TSI  concerned  and  shall  become  mandatory  from  the  moment  the  TSI  is 
applicable.  In  the  absence  of  such  standards  or  specifications  or  technical  documents  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. 

EN 

33 

   EN 

 
 
 
 
 
 
 
⌦ Drafting, adoption and review ⌫ Adoption, review and publication of TSIs 

Article 56 

(cid:208) 2008/57/EC 

1. Draft TSIs and subsequent draft amendments to TSIs shall be drafted by the Agency under 
a  mandate  from  the  Commission  in  accordance  with  the  regulatory  procedure  referred  to  in 
Article 29(3) of this Directive. They shall be drafted in accordance with Articles 3 and 12 of 
Regulation (EC) No 881/2004 and in cooperation with the working parties mentioned in those 
Articles. 

Measures  designed  to  amend  non-essential  elements  of  this  Directive  by  supplementing  it 
with  TSIs  or  amendments  thereto  shall  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny referred to in Article 29(4). 

On imperative grounds of urgency, the Commission may use the urgency procedure referred 
to in Article 29(5). 

2. The Agency shall be responsible for preparing the review and updating of TSIs and making 
any  recommendations  to  the  Commission  in  order  to  take  account  of  developments  in 
technology or social requirements. The Commission shall inform the committee referred to in 
Article 29 of such recommendations. 

(cid:216) new 

1. The Commission shall issue a mandate to the Agency to draft TSIs and their amendments 
and to make the relevant recommendations to the Commission.  

(cid:208) 2008/57/EC (adapted) 

32. Each draft TSI shall be drawn up in two ⌦ the following ⌫ stages. 

(a) Firstly, 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. 

(b) Secondly, the Agency shall 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. 

(cid:208) 2008/57/EC 
(cid:214) new 

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. 

3.  The  Agency,  in  order  to  take  account  of  developments  in  technology  or  social 
requirements,  shall  draft  the  TSIs  and  their  amendments  under  the  mandate  referred  to  in 

EN 

34 

   EN 

 
 
 
 
paragraph  1,  in  accordance  with  Articles  4  and  15  of  Regulation (EU)  No  …/…  [Agency 
Regulation]  and  by  respecting  the  principles  of  openness,  consensus  and  transparency  as 
defined in Annex II to Regulation (EU) No 1025/2012.  

45. The committee referred to in Article 29 shall be kept regularly informed of the preparatory 
work on the TSIs. During (cid:214) the preparatory work on TSIs  this work the Commission may, 
at the request of the committee, formulate any terms of reference or useful recommendations 
concerning the design of the TSIs and the cost-benefit analysis. In particular, 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. 

56. On the adoption of each TSI, the date of entry into force of that TSI shall be established in 
accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in  Article 29(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. 

67. 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. It shall enclose with the draft TSI a 
report on the results of this consultation. 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

7.  (cid:214) In  accordance  with  Article  6  of  Regulation (EU)  No  …/…  [Agency  Regulation],  the 
Agency  shall  draw  up  and  regularly  update   Tthe  list  of  ⌦ users' ⌫  associations  and 
bodies to be consulted shall be drawn up by the Commission, after consulting the committee 
in accordance with the advisory procedure referred to in Article 29(2), and ⌦ . This list ⌫ 
may be re-examined and updated at the request of a Member State or upon the initiative of the 
Commission. 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

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 54(4)(g). (cid:214) To this end, the Agency 
shall  consult  the  social  partners  before  submitting  to  the  Commission  recommendations  on 
TSIs and their amendments.  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 29.The 
social partners shall be consulted in the context of the Sectoral Dialogue Committee set up in 
accordance  with  Commission  Decision  98/500/EC  of  20  May  1998  on  the  establishment  of 
Sectoral  Dialogue  Committees  promoting  the  Dialogue  between  the  social  partners  at 
European level26. The social partners shall issue their opinion within three months. 

9. When revision of a TSI leads to a change of requirements, the new TSI version shall ensure 
compatibility with subsystems placed in service in accordance with former TSI versions. 

26 

OJ  L 225,  12.8.1998,  p. 27.  Decision  as  last  amended  by  Regulation  (EC)  No 1792/2006  (OJ  L 362, 
20.12.2006, p. 1). 

EN 

35 

   EN 

 
 
 
                                                 
10. The Commission shall be empowered to adopt delegated acts in accordance with Article 
46 concerning the TSIs and their amendments.  

Where, in the case of deficiencies discovered in TSIs in accordance with Article 6, imperative 
grounds  of  urgency  so  require,  the  procedure  provided  for  in  Article  47  shall  apply  to 
delegated acts adopted pursuant to this Article.  

In  case  a  new  authorisation,  renewal  or  upgrading  of  these  subsystems  is  needed  for  duly 
justified safety or interoperability reasons, corresponding deadlines shall be fixed either in the 
TSI or, as appropriate, by the Member States. 

10. The TSIs shall be published by the Commission in the Official Journal of the European 
Union.Article 67 

Deficiencies in TSIs 

1. If, after its adoption, it appears that a TSI does not fully meet the essential requirements, 
the committee referred to in Article 29 may be consulted at the request of a Member State or 
upon the initiative of the Commission. 

The  Commission  may  request  a  technical  opinion  from  the  Agency.  The  Commission,  with 
the involvement of the committee, shall analyse the technical opinion. 

2.  If  the  TSI  needs  to  be  amended  because  of  a  minor  error  and  this  does  not  justify  an 
immediate  revision,  the  Commission  may  recommend  that  the  technical  opinion  is  used 
pending the review of the TSI in accordance with Article 6(1). In that case, the Agency shall 
publish the technical opinion. 

3.  If  the  TSI  needs  to  be  amended  because  of  an  important  or  critical  error,  the  revision 
procedure referred to in Article 6(1) shall be applied forthwith. 

(cid:216) new 

1. If, after its adoption, it appears that a TSI has a deficiency, that TSI shall be amended in 
accordance with Article 5(3).  

2. Pending the review of the TSI, the Commission may request an opinion from the Agency. 
The  Commission  shall  analyse  the  Agency  opinion  and  inform  the  Member  States  of  its 
conclusions.  

3.  At  the  request  of  the  Commission,  the  Agency  opinions  referred  to  in  paragraph  2  shall 
constitute  acceptable  means  of  compliance  to  meet  the  essential  requirements  and  may 
therefore be used for the assessment of projects.  

(cid:208) 2008/57/EC  

Article 8 

Extension of the scope of TSIs 

1.  The  Commission  shall  adopt,  in  accordance  with  the  regulatory  procedure  referred  to  in 
Article 29(3),  one  or  more  mandates  aiming  at  the  development  of  new  TSIs  and/or  the 
review of TSIs already adopted with a view to covering lines and vehicles not yet covered. 

2. The first such mandate shall indicate a first group of new TSIs and/or amendments to TSIs 
to be adopted by January 2012, without prejudice to Article 5(5) as regards the possibility of 

EN 

36 

   EN 

 
 
 
providing  for  specific  cases  and  without  prejudice  to  Article 9  allowing  for  derogations  in 
particular  circumstances.  This  first  mandate  shall  be  drawn  up  on  the  basis  of  a 
recommendation  from  the  Agency  with  a  view  to  determining  new  TSIs  to  be  developed 
and/or  existing  TSIs  to  be  amended  in  the  light  of  the  expected  cost-effectiveness  of  each 
proposed measure and on the basis of the principle of proportionality of measures to be taken 
at Community level. To this end, appropriate consideration shall be given to Annex I, point 4 
and  the  necessary  balance  between,  on  the  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 concerned. 

3.  Until  such  time  as  the  extension  of  the  scope  of  the  TSIs  to  cover  the  whole  of  the  rail 
network takes effect: 

(a) authorisations for the placing in service 

– 

– 

of  vehicles  and  on-board  control-command  and  signalling  subsystems  to  be 
used at least partially on the part of the network that does not yet fall within the 
scope of the TSIs, in respect of that part of the network, 

of  infrastructure,  energy  and  trackside  control-command  and  signalling 
subsystems on the parts of the network that do not yet fall within the scope of 
the TSIs, 

shall  be  granted  in  accordance  with  the  national  rules  referred  to  in  Article 8  of 
Directive 2004/49/EC, or, where applicable, Article 17(3) of this Directive; 

(b) authorisations for the placing in service of vehicles to be used occasionally on the 
part of the network that does not yet fall within the scope of the TSIs, in respect of 
that part of the network, shall be granted in accordance with Articles 21 to 27 and the 
national rules referred to in Article 8 of Directive 2004/49/EC, or, where applicable, 
Article 17(3) of this Directive. 

4.  A  Member  State  need  not  apply  the  new  or  revised  TSIs  adopted  in  accordance  with 
paragraph 2  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 is published. 

(cid:208) 2008/57/EC (adapted) 

Article 79 

Derogations ⌦ Non-application of the TSIs ⌫ 

(cid:216) new 

1. Member States are allowed not to apply one or more TSIs or parts of them in the following 
cases: 

(a)  for  a  proposed  new  subsystem or  part  of  it,  for  the  renewal  or  upgrading  of  an 
existing  subsystem or  part  of  it,  or  for  any  element  referred  to  in  Article 1(1)  at  an 
advanced  stage  of  development  or  the  subject  of  a  contract  in  the  course  of 
performance at the date of application of these TSIs; 

(b)  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 

EN 

37 

   EN 

 
 
 
 
 
 
 
 
total  application  of  the  relevant  TSIs;  in  this  case,  the  non-application  of  the  TSIs 
shall be limited in time; 

(c)  for  any  proposed  renewal,  extension  or  upgrading  of  an  existing  subsystem or 
part  of  it ,  when  the  application  of  these  TSIs  would  compromise  the  economic 
viability of the project. 

2.  In  the  case  referred  to  in  paragraph 1(a),  each  Member  State  shall  communicate  to  the 
Commission, within one year of entry into force of each TSI, a list of projects that are taking 
place within its territory and which are at an advanced stage of development. 

3.  In all cases  referred  to  in  paragraph 1,  the  Member  State  concerned  shall submit  to  the 
Commission the  request  for  non-application  of  the  TSI,  also  specifying  the  alternative 
provisions that the Member State intends to apply instead of the TSIs. The Commission shall 
by  means  of  implementing  acts  establish  the  content  of  the  file  which  shall  accompany  the 
request of non-application of one or more TSIs or parts of them, the details, the format and 
the  transmission  modalities  of  that  file.  Those  implementing  acts  shall  be  adopted  in 
accordance  with  the  examination  procedure  referred  to  in  Article  48(3).  The  Commission 
shall check that file, analyse the alternative provisions that the Member State intends to apply 
instead of the TSIs, decide whether to accept or not the request of non-application of the TSI 
and inform the Member State of this decision. 

4.  Pending  the  decision  of  the  Commission,  the  Member  State  may  apply  the  alternative 
provisions as referred to in paragraph 3 without delay. 

5. The Commission shall give its decision within four months of the submission of the request 
supported by the complete file. In the absence of such a decision, the request shall be deemed 
to have been accepted.  

1. In the absence of relevant specific cases, a Member State need not apply one or more TSIs 
in accordance with this Article in the following cases: 

(cid:208) 2008/57/EC 

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

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

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

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

EN 

38 

   EN 

 
 
 
 
 
 
 
 
 
(f) for vehicles coming from or going to third countries the track gauge of which is 
different from that of the main rail network within the Community. 

2. In the cases referred to in paragraph 1, the Member State concerned shall communicate to 
the Commission a file containing the information set out in Annex IX. The Commission shall 
analyse the measures proposed by the Member State and shall inform the committee referred 
to in Article 29. 

3.  In  the  case  referred  to  in  paragraph 1(a),  within  one  year  of  entry  into  force  of  each  TSI 
each  Member  State  shall  communicate  to  the  Commission  a  list  of  projects  that  are  taking 
place within its territory and are at an advanced stage of development. 

4. In the cases referred to in paragraph 1(a), (c) and (e), the Commission shall check that the 
file is in conformity and shall inform the Member State of the results of its analysis. Where 
necessary, a recommendation shall be drawn up concerning the specifications to be applied. 
The  Member  State  may  apply  the  alternative  provisions  referred  to  in  Annex IX  without 
delay. 

5.  In  the  cases  referred  to  in  paragraph 1(b),  (d)  and  (f),  the  Commission  shall  decide,  in 
accordance  with  the  regulatory  procedure  referred  to  in  Article 29(3),  whether  to  accept  a 
request for a derogation. In the case referred to in paragraph 1(b), the Commission's decision 
shall not cover the loading gauge and the track gauge. The Commission shall give its decision 
within  six  months  of  the  submission  of  the  request  supported  by  the  complete  file.  In  the 
absence of such a decision, the request shall be deemed to have been accepted. Pending the 
Commission's decision, in the case referred to in paragraph 1(f), a Member State may apply 
the alternative provisions referred to in Annex IX. 

6. All Member States shall be informed of the results of the analyses and of the outcome of 
the procedure set out in paragraphs 3 4 and 5. 

(cid:208) 2008/57/EC 

(cid:208) 2008/57/EC 

CHAPTER III 

INTEROPERABILITY CONSTITUENTS 

Article 810 

Placing on the market of interoperability constituents 

1. 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 rail system while at the same time meeting the essential requirements; 

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

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

2. Member States may not, in their territory and on the basis of this Directive, prohibit, restrict 
or hinder the placing on the market of interoperability constituents for use in the rail system 
where they comply with this Directive. In particular, they may not require checks which have 

EN 

39 

   EN 

 
 
 
 
 
 
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.  

The Commission shall establish, by means of implementing acts, the scope and the content of 
the  EC  declaration  of  conformity  and  suitability  for  use  of  interoperability  constituents,  its 
format  and  the  details  of  the  information  included  in  it.  Those  implementing  acts  shall  be 
adopted in accordance with the examination procedure referred to in Article 48(3).  

(cid:216) new 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

Article 911 

Conformity or suitability for use 

1. Member States (cid:214) and the Agency  shall consider ⌦ as being interoperable and meeting 
the essential requirements ⌫, those interoperability constituents (cid:214) which are covered by  
which  bear  the  'EC'  declaration  of  conformity  or  suitability  for  use.  as  complying  with  the 
essential requirements of this Directive. 

(cid:208) 2008/57/EC 
(cid:214) new 

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

3.  Member  States  (cid:214) and  the  Agency   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. 

4. Spare parts for subsystems that are already placed in service when the corresponding TSI 
enters into force may be installed in these subsystems without being subject to the procedure 
referred to in paragraph 2. 

5.  TSIs  may  provide  for  a  period  of  transition  for  rail  products  identified  by  those  TSIs  as 
interoperability  constituents  which  have  already  been  placed  on  the  market  when  the  TSIs 
enter into force. Such constituents shall satisfy the requirements of Article 810(1). 

Article 12 

Non-compliance of European specifications with essential requirements 

Where it appears to a Member State or the Commission that a TSIs do not comply with the 
essential  requirements  European  specifications  used  directly  or  indirectly  to  achieve  the 
objectives of this Directive do not meet the essential requirements, the committee referred to 
in Article 29 shall be informed thereof and the Commission shall adopt the most appropriate 
measure, being: 

EN 

40 

   EN 

 
 
 
 
(a) partial or total withdrawal of the specifications concerned from the publications 
containing  them,  or  their  amendment,  after  consultation,  where  European  standards 
are involved, of the Committee set up under Directive 98/34/EC, or 

(b) review of the TSI in accordance with Article 7. 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

Article 1013 

Procedure for 'EC' declaration of conformity or suitability for use 

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 ⌦ Union ⌫ shall apply the provisions laid down by the relevant TSIs. 

2.  Where  the  corresponding  TSI  so  requires,  assessment  of  the  conformity  or  suitability  for 
use  of  an  interoperability  constituent  shall  be  carried  out  by  the  notified  ⌦ conformity 
assessment ⌫ body with which the manufacturer or his authorised representative established 
in the Community ⌦ Union ⌫ has lodged the application. 

3.  Where  interoperability  constituents  are  the  subject  of  other  Community  ⌦ Union ⌫ 
directives  covering  other  aspects,  the  'EC'  declaration  of  conformity  or  suitability  for  use 
shall, in such cases, 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  ⌦ laid  down  in ⌫  of  paragraphs 1  and  3,  those 
obligations shall be incumbent on any person who places interoperability constituents on the 
market. The same obligations shall apply to ⌦ any person who ⌫ 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.  (cid:214) In  order  to  avoid  that  interoperability  constituents  non  complying  with  essential 
requirements  are  being  placed  on  the  market, and  without   Without  prejudice  to  the 
provisions of Article 1114: 

(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  ⌦ Union ⌫  shall  be  required,  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; 

(cid:208) 2008/57/EC 

(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 in 
question,  or  to  ensure  that  it  is  withdrawn  from  the  market  in  accordance  with  the 
procedures provided for in Article 1114. 

Non-compliance of interoperability constituents with essential requirements 

Article 1114 

EN 

41 

   EN 

 
 
 
 
 
 
 
(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

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 (cid:214) or recall it  . The 
Member State  shall forthwith inform the Commission  (cid:214) and the other Member States  of 
the measures taken and give the reasons for its decision, stating in particular whether failure 
to conform is due to: 

(cid:208) 2008/57/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. 

(cid:208) 2008/57/EC (adapted) 

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 
the  Community 
⌦ Union ⌫  thereof.  Where  the  decision  referred  to  in  paragraph 1  is  justified  by  the 
existence of a gap in European specifications, the procedure set out in Article 12 shall apply. 

representative  established  within 

3.  Where  an  interoperability  constituent  bearing  the  'EC'  declaration  of  conformity  fails  to 
comply,  the  competent  Member  State  shall  take  appropriate  measures  against  whomsoever 
⌦ any  person  who ⌫  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. 

(cid:208) 2008/57/EC 

CHAPTER IV 

SUBSYSTEMS 

Article 15 

Procedure for placing in service 

1. Without prejudice to Chapter V, each Member State shall authorise the placing in service 
of those structural subsystems constituting the rail system which are located or operated in its 
territory. 

EN 

42 

   EN 

 
 
 
 
 
 
 
 
To  this  end,  Member  States  shall  take  all  appropriate  steps  to  ensure  that  these  subsystems 
may be placed in 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  rail  system.  In 
particular, they shall check: 

– 

– 

the technical compatibility of these subsystems with the system into which they are 
being integrated, 

the safe integration of these subsystems in accordance with Articles 4(3) and 6(3) of 
Directive 2004/49/EC. 

2.  Each  Member  State  shall  check,  before  these  subsystems  are  placed  in  service,  that  they 
comply, where applicable, with the relevant TSI provisions on operation and maintenance. 

3. After these subsystems have been placed in service, the check shall be carried out: 

(a)  for  infrastructures,  in  the  context  of  the  granting  and  supervision  of  safety 
authorisations under Article 11 of Directive 2004/49/EC; 

(b) for vehicles, in the context of the granting and supervision of safety certificates 
under Article 10 of Directive 2004/49/EC. 

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

(cid:208) 2008/57/EC 

Article 1216 

Free movement of subsystems 

1. Without prejudice to the provisions of Chapter V Article 15(1), Member States may not, in 
their  territory  and  on  grounds  relating  to  this  Directive,  prohibit,  restrict  or  hinder  the 
construction,  placing  in  service  and  operation  of  structural  subsystems  constituting  the  rail 
system  which  meet  the  essential  requirements.  In  particular,  they  may  not  require  checks 
which have already been carried out: 

(a) 

either  as  part  of  the  procedure  leading  to  the  'EC'  declaration  of  verification, 
the components of which are set out in Annex V, 

(b)  or in other Member States, before or after the entry into force of this Directive, 
with a view to verifying compliance with identical requirements under identical 
operational conditions. 

Article 1317 

Conformity with TSIs and national rules 

1. Member States (cid:214) and the Agency  shall consider as being interoperable and meeting the 
essential  requirements  concerning  them,  those  structural  subsystems  constituting  the  rail 
system which are covered by the 'EC' ⌦ 'EC' ⌫ declaration of verification. 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

EN 

43 

   EN 

 
 
 
 
 
(cid:208) 2008/57/EC 
(cid:214) new 

2.  Verification  of  the  interoperability,  in  accordance  with  the  essential  requirements,  of  a 
structural  subsystem  constituting  the  rail  system  shall  be  established  by  reference  to  TSIs, 
where they exist (cid:214) and national rules notified in accordance with paragraph 3 . 

3.  Member  States  shall  draw  up,  for  each  subsystem,  a  list  of  the  technical ⌦ national ⌫ 
rules in use for implementing the essential requirements and notify this list to the Commission 
when ⌦ in the following cases ⌫: 

(cid:208) 2008/57/EC (adapted) 

– 

no relevant TSI exists, or 

(cid:208) 2008/57/EC 

(cid:216) new  

(a)  when the TSIs do not fully cover certain aspects corresponding to the essential 

requirements (open points);  

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

(b)  ⌦ when ⌫  a  derogation  ⌦ non-application  of  one  or  more  TSIs ⌫  (cid:214) or 

parts of them  has been notified under Article 87; or 

(c)  ⌦ when ⌫  specific  case  requires  the  application  of  technical  rules  not 

included in the relevant TSI; 

(d) 

in case of national rules used to describe existing systems.  

(cid:216) new 

4. 
On  that  occasion,  Member  States  shall  also  designate  the  bodies  responsible  for 
⌦ establishing ⌫  to  carry  out,  in  the  case  of  these  technical  regulations,  ⌦ the  EC 
declaration of verification ⌫ referred to in Article 1815, the verification procedure.  

(cid:208) 2008/57/EC (adapted) 

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

(cid:208) 2008/57/EC 

EN 

44 

   EN 

 
 
 
 
 
 
 
 
 
(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

Article 14 
 ⌦ National rules ⌫ 

1.  (cid:214) Member  States  shall  notify  to  the  Commission  the  list  of  national  rules  referred  to  in 
Article 13(3)  This list shall be notified either: 

(a) 

(b) 

each  time  the  list  of  technical  rules  that,  pursuant  to  Article 16(3)  of 
Directive  96/48/EC  and  Article 16(3)  of  Directive  2001/16/EC,  was 
required to be notified by 30 April 2005 is changed, or 

after  ⌦ a  request  for ⌫  the  derogation  ⌦ non-application  of  the 
TSI ⌫ has been notified ⌦ submitted in accordance with Article 7 ⌫ , 
or 

(cid:208) 2008/57/EC 
(cid:214) new 

(c) 

after  publication  of  the  TSI  concerned  (cid:214) or  its  revision,  in  view  of  the 
removal of national rules made redundant by the closure of open points 
in the TSIs . 

(cid:216) new 

2.  Member  States  shall  notify  the  full  text  of  existing  national  rules  to  the  Agency  and  the 
Commission  through  the  appropriate  IT  system  in  accordance  with  article  23  of  Regulation 
(EU) No …/… [Agency Regulation]. 

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

(a) when a TSI does not fully meet the essential requirements; 

(b) as an urgent preventive measure, in particular following an accident. 

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

5.  Member  States  shall  ensure  that  national  rules,  including  those  covering  the  interfaces 
between vehicles and network, are made available free of charge and in a language that can be 
understood by all parties concerned. 

6. Member States may decide not to notify rules and restrictions of a strictly local nature. In 
such  cases,  Member  States  shall  mention  these  rules  and  restrictions  in  the  infrastructure 
registers referred to in Article 45. 

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

8. The Commission shall establish, by means of implementing acts, the classification of the 
notified national rules in different groups with the aim of facilitating the compatibility checks 
between  fixed  and  mobile  equipment.  Those  implementing  acts  shall  be  adopted  in 
accordance with the examination procedure referred to in Article 48(3).  

EN 

45 

   EN 

 
 
 
 
The  Agency  shall  classify  in  accordance  with  the  implementing  acts  referred  to  in  the  first 
subparagraph the national rules which are notified in accordance with this Article. 

9.  Draft  national  rules  and  national  rules  in  force  shall  be  examined  by  the  Agency  in 
accordance with the procedures laid down in Articles 21 and 22 of Regulation (EU) No …/… 
[Agency Regulation]. 

(cid:208) 2008/57/EC 

Member  States  shall  make  available  the  full  text  of  the  notified  rules  at  the  request  of  the 
Commission. In order to prevent further barriers from being created, and with a view to taking 
forward  the  classification  of  national  rules  in  accordance  with  Article 27,  the  Commission 
shall  monitor  the  introduction  of  new  rules  by  the  Member  States.  If  the  Commission 
considers  that  the  new  rule  constitutes  a  means  of  arbitrary  discrimination  or  a  disguised 
restriction  on  rail  transport  operations  between  Member  States,  a  decision,  addressed  to  the 
Member  State  concerned,  shall  be  adopted  in  accordance  with  the  regulatory  procedure 
referred to in Article 29(3). 

Member  States  may  choose  not  to  notify  rules  and  restrictions  of  a  strictly  local  nature.  In 
such  cases,  Member  States  shall  mention  such  rules  and  restrictions  in  the  infrastructure 
registers referred to in Article 35. 

Member States shall ensure that binding technical rules are published and made available to 
all infrastructure managers, railway undertakings and applicants for authorisations for placing 
in service in clear language that can be understood by the parties concerned. 

Procedure for establishing the 'EC' declaration of verification 

Article 1518 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

1.  In  order  to  establish  the  'EC'  declaration  of  verification,  the  applicant  shall  ⌦ ask ⌫ 
invite the notified ⌦ conformity assessment ⌫ body that it has selected for that purpose to 
apply  the  'EC'  verification  procedure  referred  to  in  Annex VI.  The  applicant  may  be  the 
contracting  entity  or  the  manufacturer,  or  their  authorised  representative  within  the 
Community ⌦ Union ⌫. 

2.  The  task  of  the  notified  ⌦ conformity  assessment ⌫  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  placed  in  service.  It  shall 
(cid:214) may   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 Articles 44 and 4534 and 35. 

3.  The  notified  ⌦ conformity  assessment ⌫  body  shall  be  responsible  for  compiling  the 
technical  file  that  has  to  accompany  the  'EC'  declaration  of  verification.  This  technical  file 
⌦ shall ⌫  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⌦ shall ⌫ 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. 

EN 

46 

   EN 

 
 
 
4. Any amendment of the technical file referred to in paragraph 3 that has an impact on the 
verifications carried out implies the need to establish a new 'EC' declaration of verification. 

(cid:216) new 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

54.  The  notified  ⌦ conformity  assessment ⌫  body  may  issue  intermediate  statement 
verifications  to  cover  certain  stages  of  the  verification  procedure  or  certain  parts  of  the 
subsystem.  In  such  a  case,  the  ⌦ verification  procedures ⌫  procedure  (cid:214) established  in 
accordance with paragraph 7(a) set out in Annex VI shall apply. 

65.  If  the  relevant  TSIs  allow,  the  notified  ⌦ conformity  assessment ⌫  body  may  issue 
certificates of conformity for a series of subsystems or certain parts of those subsystems. 

7. The Commission shall establish, by means of implementing acts: 

(cid:216) new 

(a) 

(b) 

the verification procedures for subsystems, including the general principles, the 
content,  procedure  and  documents  related  to  the  'EC'  verification  procedure, 
and to the verification procedure in the case of national rules. 

the templates for the 'EC' declaration of verification and for the declaration of 
verification  in  the  case  of  national  rules  and  templates  for  documents  of  the 
technical file that has to accompany the declaration of verification.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to Article 48(3).  

(cid:208) 2008/57/EC 

Non-compliance of subsystems with essential requirements 

Article 1619 

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  reasons  therefor.  The  Commission  shall  consult 
the interested parties. 

3. The Member State making the request shall state whether the failure to fully comply with 
this Directive is due to: 

(a)  non-compliance  with  the  essential  requirements  or  with  a  TSI,  or  incorrect 
application of a TSI; in that case, the Commission shall forthwith inform the Member 
State  where  the  person  who  drew  up  the  'EC'  declaration  of  verification  in  error 
resides and shall request that Member State to take the appropriate measures; 

EN 

47 

   EN 

 
 
 
 
 
 
(b) inadequacy of a TSI; in that case, the procedure for amending the TSI as referred 
to in Article 67 shall apply. 

(cid:216) new 

Article 17 

Presumption of conformity 

Interoperability  constituents  and  subsystems  which  are  in  conformity  with  harmonised 
standards or parts thereof the references of which have been published in the Official Journal 
of the Union shall be presumed to be in conformity with the essential requirements covered 
by those standards or parts thereof set out in Annex III. 

(cid:208) 2008/57/EC 

Article 20 

Placing in service of existing subsystems after renewal or upgrading 

1. In the event of renewal or upgrading, the contracting entity or the manufacturer 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  extent  of  the  works  means  that  a  new  authorisation  for  placing  in 
service within the meaning of this Directive is needed. 

Such  new  authorisation  for  placing  in  service  shall  be  required  whenever  the  overall  safety 
level of the subsystem concerned may be adversely 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 take  its decision not later  than four months after submission  of the 
complete file by the applicant. 

2. When a new authorisation is required and if the TSI is not fully applied, the Member States 
shall notify the following information to the Commission: 

– 

– 

– 

the reason why the TSI is not fully applied, 

the technical characteristics applicable in place of the TSI, 

the  bodies  responsible  for  applying,  in  the  case  of  those  characteristics,  the 
verification procedure referred to in Article 18. 

3.  The  Commission  shall  communicate  the  information  referred  to  in  paragraph 2  to  the 
Agency, which shall publish it. 

EN 

48 

   EN 

 
 
 
 
CHAPTER V 

VEHICLES 

(cid:216) new 

CHAPTER V 

PLACING ON THE MARKET AND PLACING IN SERVICE 

Article 18 

Placing in service of fixed installations 

The trackside control-command and signalling, energy and infrastructure subsystems 
1. 
shall be placed in service only if they are designed, constructed and installed in such a way as 
to  meet  the  essential  requirements  as  set  out  in  Annex  III,  and  the  relevant  authorisation  is 
received in accordance with paragraph 2. 

Each national safety authority shall authorise the placing in service of the energy and 

2. 
infrastructure subsystems which are located or operated in the territory of its Member State.  

The Agency shall grant decisions authorising the placing in service of the trackside control-
command and signalling subsystems located or operated throughout the Union.  

The  Agency  and  the  national  safety  authorities  shall  provide  detailed  guidance  on  how  to 
obtain  the  authorisations  referred  to  in  the  first  and  second  subparagraph.  An  application 
guidance  document  describing  and  explaining  the  requirements  for  those  authorisations  and 
listing  the  required  documents  shall  be  made  available  to  applicants  free  of  charge.  The 
Agency and the national safety authorities shall cooperate in disseminating such information. 

In  order  to  authorise  the  placing  in  service  of  the  subsystems  referred  to  in 
3. 
paragraph 1, the national safety authority or the Agency, depending on which is the competent 
authority as set out in paragraph 2, shall obtain proof of: 

(a) 

(b) 

(c) 

the EC declaration of verification; 

the technical compatibility of these subsystems with the system into which they 
are  being  integrated,  established  on  the  basis  of  the  relevant  TSIs,  national 
rules and registers; 

the safe integration of these subsystems, established on the basis of the relevant 
TSIs,  national  rules,  registers,  and  the  common  safety  methods  set  out  in 
Article 6 of Directive…/… [on the safety of the rail system within the Union]. 

4. 
In the event of renewal or upgrading of existing subsystems, the applicant shall send 
to the national safety authority (for energy and infrastructure subsystems) or the Agency (for 
trackside  control-command  and  signalling  subsystems),  a  file  describing  the  project.  The 
national safety authority or the Agency shall examine this file and shall decide, on the basis of 
the  criteria  set  out  in  paragraph  5,  whether  a  new  authorisation  for  placing  in  service  is 
needed.  The  national  safety  authority  and  the  Agency  shall  take  their  decisions  within  a 
pre-determined,  reasonable  time,  and,  in  any  case,  within  four  months  from  receipt  of  all 
relevant information.  

EN 

49 

   EN 

 
 
5. 
In the event of renewal or upgrading of existing subsystems, a new 'EC' declaration of 
verification  shall  be  needed  as  set  out  in  Article  15(4).  In  addition,  a  new  authorisation  for 
placing in service shall be required when: 

(a) 

(b) 

(c) 

the overall safety level of the subsystem concerned may be adversely affected 
by the works envisaged; or 

it is required by the relevant TSIs; or 

it is required by the national implementation plans established by the Member 
States. 

Article 19 

Placing on the market of mobile subsystems 

1. 
The  rolling  stock  subsystem  and  the  on-board  control-command  and  signalling 
subsystem  shall  be  placed  on  the  market  by  the  applicant  only  if  they  are  designed, 
constructed  and  installed  in  such  a  way  as  to  meet  the  essential  requirements  as  set  out  in 
Annex III. 

In particular, the applicant shall ensure that the EC declaration of verification has been 

2. 
provided. 

In the event of renewal or upgrading of existing subsystems, a new 'EC' declaration of 

3. 
verification shall be needed as set out in Article 15(4). 

(cid:208) 2008/57/EC 

Article 21 

Authorisation for placing in service of vehicles 

1. Before being used on a network, a vehicle shall be authorised to be placed in service by the 
national safety authority which is competent for this network, unless otherwise provided for in 
this Chapter. 

2. A TSI conform vehicle shall be authorised in accordance with Articles 22 or 23. 

3. A non-TSI conform vehicle shall be authorised in accordance with Articles 24 or 25. 

4.  A  vehicle  which  conforms  to  an  authorised  type  shall  be  authorised  in  accordance  with 
Article 26. 

5. An authorisation granted by one Member State shall be valid in all Member States, without 
prejudice  to  the  provisions  of  Articles 23  and  25  concerning  additional  authorisations. 
Member States shall clarify, by adopting specific national rules or through national provisions 
implementing this Directive, whether additional authorisations are needed in accordance with 
the relevant provisions of Article 23 in the case of TSI conform vehicles or Article 25 in the 
case of non-TSI conform vehicles. 

6. All applications for an authorisation to place in service shall be the subject of a decision by 
the competent national safety authority, pursuant to Articles 22 and 23 or Articles 24 and 25. 
The authorisation to place in service may stipulate conditions of use and other restrictions. 

7. Any decision by a competent national safety authority refusing the placing in service of a 
vehicle  shall  be  duly  substantiated.  The  applicant  may  within  a  period  of  one  month  from 
receipt of the negative decision request that the competent national safety authority reviewed 

EN 

50 

   EN 

 
 
the  decision  for  duly  justified  reasons.  The  national  safety  authority  shall  then  have  two 
months starting from receipt of the appeal to confirm or reverse its decision. If the negative 
decision  is  confirmed,  the  applicant  may  request  that  the  appeal  body  designated  by  the 
competent Member State under Article 17(3) of Directive 2004/49/EC review the decision for 
duly justified reasons. Member States may designate the regulatory body set up in accordance 
with Article 30 of Directive 2001/14/EC for the purpose of this appeal procedure. 

8.  In  the  absence  of  a  decision  of  the  competent  national  safety  authority  as  referred  to  in 
Articles 23(7) and 25(5) within the prescribed time limits, the placing in service of the vehicle 
in question shall be deemed to have been authorised after a period of three months starting at 
the  end  of  these  time  limits.  The  authorisations  granted  pursuant  to  this  paragraph  are  only 
valid on the network for which the competent national safety authority did not react within the 
prescribed limits. 

9.  A  national  safety  authority  which  intends  to  revoke  an  authorisation  to  place  in  service 
granted by itself or an authorisation granted to the applicant pursuant to paragraph 8 shall use 
the  procedure  for  revision  of  safety  certificates  referred  to  in  Article 10(5)  of  Directive 
2004/49/EC or, where applicable, the procedure for revision of safety authorisations referred 
to in Article 11(2) of that Directive. 

10. In the case of an appeal procedure, the competent appeal body referred to in paragraph 7 
may request from the Agency an opinion which, in that case, shall be issued within one month 
of the request being filed and notified to the applicant, to the competent appeal body and to 
the competent national safety authority which refuses to grant the authorisation. 

11. In the case of vehicles running between a Member State and a third country, on a network 
whose track gauge is different from that of the main rail network within the Community and 
for which a derogation may be granted in accordance with Article 9(5) or which are subject to 
specific  cases,  the  national  rules  referred  to  in  Articles 22  and  24  may  include  international 
agreements in so far as they are compatible with Community legislation. 

12.  Authorisations  for  placing  in  service  which  have  been  granted  before  19 July  2008, 
including  authorisations  delivered  under  international  agreements,  in  particular  RIC 
(Regolamento Internazionale Carrozze) and RIV (Regolamento Internazionale Veicoli), shall 
remain  valid  in  accordance  with  the  conditions  under  which  the  authorisations  have  been 
granted. This provision takes precedence over Articles 22 to 25. 

13. Member States may grant authorisations to place in service a series of vehicles. To that 
end, the national safety authorities shall notify the applicant of the procedure to be followed. 

14.  Authorisations  for  placing  in  service  granted  in  accordance  with  this  Article  shall  be 
without  prejudice  to  other  conditions  imposed  on  railway  undertakings  and  infrastructure 
managers for operating such vehicles on the relevant network, pursuant to Articles 9, 10 and 
11 of Directive 2004/49/EC. 

(cid:216) new 

Article 20 

Vehicle authorisation for placing on the market 

1. 
A  vehicle  shall  be  placed  on  the  market  only  after  having  received  the  vehicle 
authorisation for placing on the market issued by the Agency in accordance with paragraph 5.  

EN 

51 

   EN 

 
 
2. 
The  Agency  shall  issue  decisions  granting  vehicle  authorisations  for  placing  on  the 
market.  Those  authorisations  attest  the  values  of  the  parameters  relevant  for  checking  the 
technical compatibility between the vehicle and the fixed installations as set out in the TSIs. 
The vehicle authorisation for placing on the market shall also provide information about the 
vehicle’s  compliance  with  the  relevant  TSIs  and  sets  of  national  rules,  related  to  these 
parameters. 

The  vehicle  authorisation  for  placing  on  the  market  may  stipulate  conditions  for  the 

3. 
use of the vehicle and other restrictions. 

4. 
The vehicle authorisation for placing on the market shall be issued on the basis of a 
file of the vehicle or type of vehicle produced by the applicant and including the documentary 
evidence of: 

(a) 

(b) 

(c) 

the  placing  on  the  market  of  the  mobile  subsystems  composing  the  vehicle 
according to Article 19; 

the technical compatibility of the subsystems referred to in point (a) within the 
vehicle,  established  on  the  basis  of  the  relevant  TSIs,  national  rules  and 
registers; 

the safe integration of the subsystems referred to in point (a) within the vehicle, 
established on the basis of the relevant  TSIs,  national  rules,  and  the  common 
safety methods set out in Article 6 of Directive …/… [on the safety of the rail 
system within the Union]. 

The  Agency  shall  take  the  decisions  referred  to  in  paragraph  2  within  a 
5. 
pre-determined,  reasonable  time,  and,  in  any  case,  within  four  months  from  receipt  of  all 
relevant information. These authorisations shall be valid in all Member States.  

The  Agency  shall  provide  detailed  guidance  on  how  to  obtain  the  vehicle  authorisation  for 
placing  on  the  market.  An  application  guidance  document  describing  and  explaining  the 
requirements for the vehicle authorisation for placing on the market and listing the required 
documents shall be made available to applicants free of charge. The national safety authorities 
shall cooperate with the Agency in disseminating such information. 

The Agency may issue vehicle authorisation for placing on the market for a series of 

6. 
vehicles. Those authorisations shall be valid in all Member States. 

The  applicant  may  bring  an  appeal  before  the  Board  of  Appeal  designated  under 
7. 
Article  51  of  Regulation  (EU)  No …/…  [establishing  a  European  railway  agency]  against 
decisions of the Agency or its failure to act within the time limits referred to in paragraph 5. 

In the event of renewal or upgrading of existing vehicles which already have a vehicle 

8. 
authorisation for placing on the market: 

(a) 

(b) 

a  new  'EC'  declaration  of  verification  shall  be  needed  as  set  out  in  Article 
15(4), and 

a new vehicle authorisation for placing on the market shall be required if any 
changes  are  made  to  the  values  of  the  parameters  included  in  the  vehicle 
authorisation already granted. 

9.  At  the  request  of  the  applicant,  the  vehicle  authorisation  for  placing  on  the  market  may 
include a clear indication of the networks or lines  or groups of networks or lines where the 
railway undertaking may place such a vehicle in service without further verifications, checks 
or  tests  concerning  the  technical  compatibility  between  the  vehicle  and  these  networks  or 

EN 

52 

   EN 

 
lines.  In  that  case,  the  applicant  shall  include  in  its  request  the  proof  of  the  technical 
compatibility of the vehicle with the networks or lines concerned. 

This indication may be also added, at the request of the original or another applicant, after the 
relevant authorisation for placing on the market has been issued. 

Article 21 

Placing in service of vehicles 

Railway undertakings shall place in service a vehicle only after having checked, , in 
1. 
consultation with the infrastructure manager, the technical compatibility between the vehicle 
and the route and the safe integration of the vehicle into the system in which it is intended to 
operate,  established  on  the  basis  of  the  relevant  TSIs,  national  rules,  registers,  and  the 
common safety methods set out in Article 6 of Directive.  

To this aim, vehicles shall first receive the vehicle authorisation for placing on the market in 
accordance with Article 20. 

2. 
The railway undertaking shall communicate its decisions with respect to the placing in 
service of vehicles to the Agency, the infrastructure manager and the national safety authority 
concerned.  These  decisions  shall  be  recorded  in  the  national  vehicle  registers  referred  to  in 
Article 43. 

3. 
In  the  event  of  renewal  or  upgrading  of  existing  vehicles,  a  new  'EC'  declaration  of 
verification shall be needed as set out in Article 15(4). In addition, a new decision taken by 
the railway undertaking for placing in service of these vehicles shall be required when: 

(a) 

the overall safety level of the subsystem concerned may be adversely affected 
by the works envisaged, or 

(b) 

it is required by the relevant TSIs. 

(cid:208) 2008/57/EC 

Article 22 

First authorisation for placing in service of TSI conform vehicles 

1.  This  Article  shall  apply  to  vehicles  which  are  in  conformity  with  all  the  relevant  TSIs 
which are in force at the moment of placing in service, provided that a significant part of the 
essential requirements is laid down in these TSIs and that the relevant TSI on rolling stock has 
entered into force and is applicable. 

2. The first authorisation shall be granted by a national safety authority as follows: 

(a)  where  all  the  structural  subsystems  of  a  vehicle  have  been  authorised  in 
conformity  with  the  provisions  of  Chapter IV,  the  authorisation  shall  be  granted 
without further checks; 

(b)  in  the  case  of  vehicles  bearing  all  necessary  'EC'  declarations  of  verification  as 
provided  for  in  Article 18,  the  criteria  which  a  national  safety  authority  may  check 
with a view to granting an authorisation for placing in service may concern only: 

– 

– 

technical  compatibility  between  the  vehicle’s  relevant  subsystems  and  their 
safe integration in accordance with Article 15(1), 

technical compatibility between the vehicle and the network concerned, 

EN 

53 

   EN 

 
 
 
 
– 

– 

national rules applicable to the open points, 

national  rules  applicable  to  the  specific  cases  duly  identified  in  the  relevant 
TSIs. 

Article 23 

Additional authorisations for placing in service of TSI conform vehicles 

1. Vehicles in complete conformity with TSIs covering all aspects of the relevant subsystems 
without  specific  cases  and  without  open  points  strictly  related  to  technical  compatibility 
between vehicle and network, shall not be subject to any additional authorisation for placing 
in service as long as they run on TSI conform networks in the other Member States or under 
the conditions specified in the corresponding TSIs. 

2. In the case of vehicles placed in service in accordance with Article 22 but not covered by 
paragraph 1,  Member  States  shall  decide  if  additional  authorisations  are  necessary  on  their 
territory. In this case, paragraphs 3 to 7 shall apply. 

3. The applicant shall submit to the national safety authority a file on the vehicle or type of 
vehicle  and  the  intended  use  thereof  on  the  network.  The  file  shall  contain  the  following 
information: 

(a)  documentary  evidence  that  the  placing  in  service  of  the  vehicle  has  been 
authorised in another Member State in accordance with Article 22; 

(b) a copy of the technical file as referred to in Annex VI. This shall include, in the 
case  of  vehicles  equipped  with  data  recorders,  information  on  the  data  collection 
procedure,  permitting  read  out  and  evaluation,  as  long  as  this  information  is  not 
harmonised by the corresponding TSI; 

(c)  records  showing  the  vehicle’s  maintenance  history  and,  where  applicable, 
technical modifications undertaken after the authorisation; 

(d) evidence on technical and operational characteristics that shows that the vehicle 
is  compatible  with  the  infrastructures  and  fixed  installations,  including  climate 
conditions,  energy  supply  system,  control-command  and  signalling  system,  track 
gauge and infrastructure gauges, maximum permitted axle load and other constraints 
of the network. 

4. The criteria checked by a national safety authority may concern only: 

– 

– 

technical compatibility between the vehicle and the network concerned, including the 
national rules applicable to the open points needed to ensure such compatibility, 

the national rules applicable to the specific cases duly identified in the relevant TSIs. 

5.  The  national  safety  authority  may  request  additional  information  to  be  supplied,  risk 
analyses to be carried out in accordance with Article 6(3)(a) of Directive 2004/49/EC or tests 
to  be  conducted  on  the  network  in  order  to  verify  the  criteria  referred  to  in  paragraph 4. 
However,  after  the  adoption  of  the  reference  document  referred  to  in  Article 27  of  this 
Directive, the national safety authority may only carry out such verification on the basis of the 
national rules relating to Group B or C featuring in that document. 

6. The national safety authority shall define, after consultation with the applicant, the scope 
and  content  of  the  additional  information,  the  risk  analyses  and  the  tests  requested.  The 
infrastructure  manager,  in  consultation  with  the  applicant,  shall  make  every  effort  to  ensure 

EN 

54 

   EN 

 
 
 
 
 
that any tests take place within three months of the applicant’s request. Where appropriate, the 
national safety authority shall take measures to ensure that the tests take place. 

7. All applications for an authorisation to place in service submitted in accordance with this 
Article shall be the subject of a decision by the national safety authority, to be taken as soon 
as possible and not later than: 

(a) two months after submission of the file referred to in paragraph 3; 

(b)  where  applicable,  one  month  after  provision  of  any  additional  information 
requested by the national safety authority; 

(c) where applicable, one month after provision of the results of any tests requested 
by the national safety authority. 

Article 24 

First authorisation for placing in service of non-TSI conform vehicles 

1. This Article shall apply to vehicles which are not in conformity with all the relevant TSIs in 
force at the moment of placing in service, including vehicles subject to derogations, or where 
a significant part of the essential requirements is not laid down in one or more TSIs. 

2. The first authorisation shall be granted by a national safety authority as follows: 

– 

– 

for  the  technical  aspects  covered  by  a  TSI,  if  any,  the  'EC'  verification  procedure 
shall apply, 

for the other technical aspects, national rules as notified under Article 17(3) of this 
Directive and under Article 8 of Directive 2004/49/EC shall apply. 

This first authorisation shall be valid only on the network of the Member State granting it. 

Article 25 

Additional authorisations for placing in service of non-TSI conform vehicles 

1.  In  the  case  of  vehicles  that  have  been  authorised  to  be  placed  in  service  in  one  Member 
State  in  accordance  with  Article 21(12)  or  Article 24,  other  Member  States  may  decide  in 
accordance  with  this  Article  whether  additional  authorisations  to  place  in  service  are 
necessary on their territory. 

2. The applicant shall submit to the national safety authority a technical file on the vehicle or 
type of vehicle, together with details of planned use on the network. The file shall contain the 
following information: 

(a)  documentary  evidence  that  the  placing  in  service  of  the  vehicle  has  been 
authorised  in  another  Member  State  together  with  documentation  on  the  procedure 
followed in order to show that the vehicle complied with the safety requirements in 
force, including, where applicable, information on derogations enjoyed or granted in 
accordance with Article 9; 

the 

technical  data, 

the  operational 
(b) 
characteristics.  This  shall  include,  in  the  case  of  vehicles  equipped  with  data 
recorders,  information  on  the  data  collection  procedure,  permitting  read  out  and 
evaluation as provided for in Article 20(2)(c) of Directive 2004/49/EC; 

the  maintenance  programme  and 

(c)  records  showing  the  vehicle’s  history  of  operation,  maintenance  and,  where 
applicable, technical modifications undertaken after the authorisation; 

EN 

55 

   EN 

 
 
 
 
 
 
 
(d) evidence on technical and operational characteristics that shows that the vehicle 
is  compatible  with  the  infrastructures  and  fixed  installations,  including  climate 
conditions,  energy  supply  system,  control-command  and  signalling  system,  track 
gauge and infrastructure gauges, maximum permitted axle load and other constraints 
of the network. 

3. The information referred to in paragraph 2(a) and (b) may not be called into question by the 
national  safety  authority,  save  where  the  latter  is  able  to  demonstrate  without  prejudice  to 
Article 16  the  existence  of  a  substantial  safety  risk.  After  the  adoption  of  the  reference 
document referred to in Article 27, the national safety authority may not invoke in this regard 
any Group A rule listed in that document. 

4.  The  national  safety  authority  may  request  additional  information  to  be  supplied,  risk 
analyses to be carried out in accordance with Article 6(3)(a) of Directive 2004/49/EC or tests 
to  be  conducted  on  the  network  in  order  to  verify  that  the  information  referred  to  in 
paragraph 2(c) and (d) of this Article complies with the national rules in force as notified to 
the  Commission  pursuant  to  Article 8  of  Directive  2004/49/EC  or  to  Article 17  of  this 
Directive. However, after the adoption of the reference document referred to in Article 27 of 
this Directive, the national safety authority may only carry out such verification on the basis 
of the national rules relating to Group B or C listed in that document. 

The national safety authority shall define, after consultation with the applicant, the scope and 
content  of  the  additional  information,  the  risk  analyses  or  the  tests  requested.  The 
infrastructure  manager,  in  consultation  with  the applicant,  shall  make  every  effort  to  ensure 
that any tests take place within three months of the applicant’s request. Where appropriate, the 
national safety authority shall take measures to ensure that the tests take place. 

5. All applications for an authorisation to place in service submitted in accordance with this 
Article shall be the subject of a decision by the national safety authority, to be taken as soon 
as possible and not later than: 

(a) four months after submission of the technical file referred to in paragraph 2; 

(b) where applicable, two months after provision of the additional information or risk 
analyses requested by the national safety authority pursuant to paragraph 4; 

(c) where applicable, two months after provision of the results of the tests requested 
by the national safety authority pursuant to paragraph 4. 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

Article 2226 

Authorisation for ⌦ to place vehicle ⌫ types of vehicles ⌦ on the market ⌫ 

1. (cid:214) The Agency shall  Member States may grant authorisations for ⌦ to place vehicle ⌫ 
types of vehicles ⌦ on the market ⌫ . 

The  Agency  shall  provide  detailed  guidance  on  how  to  obtain  the  authorisation  to  place 
vehicle types on the market. An application guidance document describing and explaining the 
requirements for the authorisation to place vehicle types on the market and listing the required 

(cid:216) new 

EN 

56 

   EN 

 
 
 
 
 
 
 
documents shall be made available to applicants free of charge. The national safety authorities 
shall cooperate with the Agency in disseminating such information. 

(cid:208) 2008/57/EC 
(cid:214) new 

2. However, if (cid:214) the Agency  Member States (cid:214) issues a vehicle authorisation for placing 
on  the  market,  it  authorise  a  vehicle,  they  shall  at  the  same  time  authorise  (cid:214) issue  the 
authorisation to place the corresponding vehicle type on the market  the type of vehicle. 

A  vehicle  which  is  in  conformity  with  a  vehicle  type  for  which  an  authorisation  to 
3. 
place  the  corresponding  vehicle  type  on  the  market  has  been  already  issued  shall,  without 
further  checks,  receive  a  vehicle  authorisation  for  placing  on  the  market  on  the  basis  of  a 
declaration of conformity to this type submitted by the applicant. 

(cid:216) new 

(cid:208) 2008/57/EC 

3.  A  vehicle  which  conforms  to  a  type  already  authorised  in  a  Member  State  shall  be 
authorised  by  that  Member  State  on  the  basis  of  a  declaration  of  conformity  to  this  type 
submitted by the applicant without further checks. However, where the relevant provisions in 
TSIs and national rules on the basis of which a type of vehicle was authorised have changed, 
Member States shall decide if authorisations of type already granted remain valid or need to 
be  renewed.  The  criteria  which  a  national  safety  authority  checks  in  the  case  of  a  renewed 
authorisation  of  type  may  only  concern  the  changed  rules.  The  renewal  of  the  type 
authorisation  does  not  affect  authorisations  of  vehicles  already  granted  on  the  basis  of 
previously authorised types. 

(cid:216) new 

4. 
In  the  event  of  changes  to  any  relevant  provisions  in  TSIs  or  national  rules,  on  the 
basis of which an authorisation to place a vehicle type on the market has been issued, the TSI 
or  national  rule  shall  determine  whether  the  authorisation  to  place  that  vehicle  type  on  the 
market already granted remains valid or needs to be renewed. If that authorisation needs to be 
renewed,  the  checks  performed  by  the  Agency  may  only  concern  the  changed  rules.  The 
renewal  of  the  authorisation  to  place  a  vehicle  type  on  the  market  does  not  affect  vehicle 
authorisations  for  placing  on  the  market  already  issued  on  the  basis  of  the  previous 
authorisation to place that vehicle type on the market. 

(cid:208) 2008/57/EC 
(cid:214) new 

54.  The  model  of  declaration  of  conformity  to  type  shall  be  adopted  (cid:214) established  in 
accordance with Decision 2010/713/EU  by the Commission by 19 July 2009 on the basis 
of a draft prepared by the Agency and in accordance with the regulatory procedure referred to 
in Article 29(3). 

65. The declaration of conformity to type shall be established in accordance with: 

(a) for TSI-conform vehicles, the verification procedures of the relevant TSIs; 

EN 

57 

   EN 

 
 
 
 
 
 
 
(b) for non-TSI conform vehicles, the verification procedures as defined in modules 
D or E of Decision 93/465/EEC. Where appropriate, the Commission may adopt an 
ad hoc verification procedure in accordance with the regulatory procedure referred to 
in Article 29(3). 

(cid:216) new 

(b) for non-TSI-conform vehicles, the conformity assessment procedures as defined 
in  modules  B+D  and  B+F of  Decision 768/2008/EC.  Where  appropriate,  the 
Commission  may  adopt  implementing  acts  establishing  ad  hoc  modules  for 
conformity assessment. Those implementing acts shall be adopted in accordance with 
the examination procedure referred to in Article 48(3).  

6. The applicant may request a type authorisation in several Member States at the same time. 
In  this  case,  national  safety  authorities  shall  cooperate  with  a  view  to  simplifying  the 
procedure and minimising administrative efforts. 

(cid:208) 2008/57/EC 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

7. Type authorisations (cid:214) The authorisation to place vehicle types on the market  shall be 
registered in the European register of authorised (cid:214) authorisations to place a vehicle types on 
the  market    types  of  vehicles  referred  to  in  Article 4434.  This  register  shall  specify  the 
Member State or Member States in which a type of vehicle is authorised. 

(cid:208) 2008/57/EC 

Article 27 

Classification of national rules 

1. In order to facilitate the procedure for authorising the placing in service of vehicles referred 
to in Article 25, national rules shall be classified pursuant to Annex VII. 

2.  Without  prejudice  to  Article 30(3),  the  Agency  shall,  by  19 January  2009,  review  the 
parameters  set  out  in  section 1  of  Annex VII  and  make  the  recommendations  it  considers 
appropriate to the Commission. 

3. The Agency shall draw up a recommendation for a reference document cross-referencing 
all  the  national  rules  applied  by  the  Member  States  for  placing  vehicles  in  service.  The 
national safety authorities shall cooperate with the Agency in this task. 

4. The Commission shall adopt the reference document, as well as any decision to update it, 
on  the  basis  of  the  Agency’s  recommendation  and  in  accordance  with  the  regulatory 
procedure referred to in Article 29(3). 

EN 

58 

   EN 

 
 
 
 
 
 
 
CHAPTER VI 

NOTIFIED BODIES ⌦ NOTIFICATION OF CONFORMITY 
ASSESMENT BODIES ⌫  

(cid:208) 2008/57/EC (adapted) 

(cid:208) 2008/57/EC 

Article 28 

Notified bodies 

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 
Union  the  list  of  bodies,  their  identification  numbers  and  areas  of  responsibility,  and  shall 
keep this list updated. 

2. Member States shall apply the criteria provided for in Annex VIII 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 those criteria. 

3. A Member State shall withdraw approval from a body which no longer meets the criteria 
referred  to  in  Annex VIII.  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  criteria  referred  to  in  Annex VIII,  the  Commission  shall 
consult the parties concerned. The Commission shall inform the latter Member State of any 
changes that are necessary for the notified body to retain the status conferred upon it. 

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 29 of the 
work  carried  out  in  the  framework  of  the  Coordination  Group.  The  Commission,  when 
appropriate,  will  propose  the  measures  needed  to  remedy  the  problems.  Where  necessary, 
coordination of the notified bodies shall be implemented in accordance with Article 30(4). 

6. The first of the reports referred to in Article 39 shall also assess the implementation of the 
criteria specified in Annex VIII, and, if necessary, propose appropriate measures. 

EN 

59 

   EN 

 
 
 
(cid:216) new 

Article 23 

Notification 

Member States shall notify the Commission and the other Member States of bodies authorised 
to carry out third-party conformity assessment tasks under this Directive. 

Article 24 

Notifying authorities 

1. Member States shall designate a notifying authority that shall be responsible for setting up 
and carrying out the necessary procedures for the assessment and notification of conformity 
assessment  bodies  and  the  monitoring  of  notified  conformity  assessment  bodies,  including 
compliance with the provisions of Articles 27 to 29. 

2. Member States may decide that the assessment and monitoring referred to in paragraph 1 
shall be carried out by a national accreditation body within the meaning of and in accordance 
with Regulation (EC) No 765/2008. 

3. Where the notifying authority delegates or otherwise entrusts the assessment, notification 
or  monitoring  referred  to  in  paragraph  1  to  a  body  which  is  not  a  governmental  entity,  that 
body shall be a legal entity and shall comply with the requirements laid down in Article 25. It 
shall put in place arrangements to cover liabilities arising out of its activities. 

4.  The  notifying  authority  shall  take  full  responsibility  for  the  tasks  performed  by  the  body 
referred to in paragraph 3. 

Article 25 

Requirements relating to notifying authorities 

1.  A  notifying  authority  shall  be  established  in  such  a  way  that  no  conflict  of  interest  with 
conformity assessment bodies occurs. 

2. A notifying authority shall be organised and operated so as to safeguard the objectivity and 
impartiality of its activities. 

3.  A  notifying  authority  shall  be  organised  in  such  a  way  that  each  decision  relating  to 
notification  of  a  conformity  assessment  body  is  taken  by  competent  persons  different  from 
those who carried out the assessment. 

4.  A  notifying  authority  shall  not  offer  or  provide  any  activities  that  are  performed  by 
conformity assessment bodies or consultancy services on a commercial or competitive basis. 

5. A notifying authority shall safeguard the confidentiality of the information it obtains. 

6. A notifying authority shall have a sufficient number of competent personnel at its disposal 
for the proper performance of its tasks. 

Article 26 

Information obligation on notifying authorities 

EN 

60 

   EN 

 
 
Member  States  shall  inform  the  Commission  of  their  procedures  for  the  assessment  and 
notification  of  conformity  assessment  bodies  and  the  monitoring  of  notified  bodies,  and  of 
any changes thereto. 

The Commission shall make that information publicly available. 

Article 27 

Requirements relating to conformity assessment bodies 

1. For the purposes of notification, a conformity assessment body shall meet the requirements 
laid  down  in  paragraphs  2  to  7  and  in  Articles  28  and  29.  These  requirements  are  also 
applicable to bodies designated by Member States pursuant to Article 13(4). 

2.  A  conformity  assessment  body  shall  be  established  under  national  law  and  have  legal 
personality. 

3.  A  conformity  assessment  body  shall  be  capable  of  carrying  out  all  the  conformity 
assessment  tasks  assigned  to  it  by  the  relevant  TSI  and  in  relation  to  which  it  has  been 
notified, whether those tasks are carried out by the conformity assessment body itself or on its 
behalf and under its responsibility. 

At  all  times  and  for  each  conformity  assessment  procedure  and  each  kind  or  category  of 
products in relation to which it has been notified, a conformity assessment body shall have at 
its disposal : 

(a)  the  necessary  personnel  with  technical  knowledge  and  sufficient  and  appropriate 
experience to perform the conformity assessment tasks; 

(b) the relevant descriptions of procedures in accordance with which conformity assessment is 
carried out, ensuring the transparency and the ability of reproduction of those procedures. It 
shall  have  appropriate  policies  and  procedures  in  place  that  distinguish  between  tasks  it 
carries out as a notified conformity assessment body and other activities; 

(c) the proper procedures for the performance of activities which take due account of the size 
of an undertaking, the sector in which it operates, its structure, the degree of complexity of the 
product technology in question and the mass or serial nature of the production process. 

It shall have the means necessary to perform the technical and administrative tasks connected 
with the conformity assessment activities in an appropriate manner and shall have access to 
all necessary equipment or facilities. 

4. Conformity assessment bodies shall take out liability insurance unless liability is assumed 
by the State in accordance with national law, or the Member State itself is directly responsible 
for the conformity assessment. 

5.  The  personnel  of  a  conformity  assessment  body  shall  observe  professional  secrecy  with 
regard  to  all  information  obtained  in  carrying  out  their  tasks  under  the  relevant  TSI  or  any 
provision of national law giving effect to it, except in relation to the competent authorities of 
the Member State in which its activities are carried out. Proprietary rights shall be protected. 

6. Conformity assessment bodies shall participate in, or ensure that their assessment personnel 
are  informed  of,  the  relevant  standardisation  activities  and  the  activities  of  the  notified 
conformity  assessment  bodies  coordination  group  established  under  the  relevant  Union's 
legislation  and  apply  as  general  guidance  the  administrative  decisions  and  documents 
produced as a result of the work of that group. 

EN 

61 

   EN 

 
7.  Conformity  assessment  bodies  shall  participate  in,  or  shall  ensure  that  their  assessment 
personnel  are  informed  of,  the  activities  of  the  ERTMS  ad  hoc  working  group  set  out  in 
Article 25 of Regulation (EU) No …/… [establishing a European railway agency]. They shall 
follow the guidelines produced as a result of the work of that group. In case they consider it 
inappropriate or impossible to apply them, the conformity assessment bodies concerned shall 
submit  their  observations  for  discussion  to  the  ERTMS  ad  hoc  working  group  for  the 
continuous improvement of the guidelines. 

Article 28 
Impartiality of conformity assessment bodies 

1.  A  conformity  assessment  body  shall  be  a  third-party  body  independent  from  the 
organisation or from the manufacturer of the product it assesses. 

A  body  belonging  to  a  business  association  or  professional  federation  representing 
undertakings involved in the design, manufacturing, provision, assembly, use or maintenance 
of products which it assesses, may, on condition that its independence and the absence of any 
conflict of interest are demonstrated, be considered such a body. 

2. The impartiality  of  the  conformity assessment bodies,  their top level management and of 
the assessment personnel shall be guaranteed. 

3. A conformity assessment body, its top level management and the personnel responsible for 
carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, 
installer,  purchaser,  owner,  user  or  maintainer  of  the  products  which  they  assess,  nor  the 
authorised representative of any of those parties. This shall not preclude the use of assessed 
products that are necessary for the operations of the conformity assessment body or the use of 
such products for personal purposes. 

4. A conformity assessment body, its top level management and the personnel responsible for 
carrying  out  the  conformity  assessment  tasks  shall  not  be  directly  involved  in  the  design, 
manufacture  or  construction,  the  marketing,  installation,  use  or  maintenance  of  those 
products,  or  represent  the  parties  engaged  in  those  activities.  They  shall  not  engage  in  any 
activity  that  may  conflict  with  their  independence  of  judgement  or  integrity  in  relation  to 
conformity assessment activities for which they are notified. This shall in particular apply to 
consultancy services. 

5.  Conformity  assessment  bodies  shall  ensure  that  the  activities  of  their  subsidiaries  or 
subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity 
assessment activities. 

6.  Conformity  assessment  bodies  and  their  personnel  shall  carry  out  the  conformity 
assessment  activities  with  the  highest  degree  of  professional  integrity  and  the  requisite 
technical  competence  in  the  specific  field  and  shall  be  free  from  all  pressures  and 
inducements,  particularly  financial,  which  might  influence  their  judgement  or  the  results  of 
their conformity assessment activities, especially as regards persons or groups of persons with 
an interest in the results of those activities. 

Article 29 
Personnel of conformity assessment bodies 

1. The personnel responsible for carrying out conformity assessment activities shall have the 
following skills: 

EN 

62 

   EN 

 
(a) sound technical and vocational training covering all the conformity assessment activities 
in relation to which the conformity assessment body has been notified; 

(b) satisfactory knowledge of the requirements of the assessments they carry out and adequate 
authority to carry out those assessments; 

(c) appropriate knowledge and understanding of the essential requirements, of the applicable 
harmonised  standards  and  of  the  relevant  provisions  of  Union's  legislation  and  of  its 
implementing regulations; 

(d) the ability to draw up certificates, records and reports demonstrating that assessments have 
been carried out. 

2. The remuneration of the top level management and assessment personnel of a conformity 
assessment body shall not depend on the number of assessments carried out or on the results 
of those assessments. 

Article 30 

Presumption of conformity of a conformity assesment body 

Where a conformity assessment body demonstrates its conformity with the criteria laid down 
in  the  relevant  harmonised  standards  or  parts  thereof  the  references  of  which  have  been 
published in the Official Journal of the European Union, it shall be presumed to comply with 
the requirements set out in Articles 27 to 29, in so far as the applicable harmonised standards 
cover those requirements. 

Article 31 

Subsidiaries of and subcontracting by conformity asssessment bodies 

1.  Where  a  notified  conformity  assessment  body  subcontracts  specific  tasks  connected  with 
conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or 
the  subsidiary  meets  the  requirements  set  out  in  Articles  27  to  29  and  shall  inform  the 
notifying authority accordingly. 

2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or 
subsidiaries wherever these are established. 

3. Activities of notified bodies may be subcontracted or carried out by a subsidiary only with 
the agreement of the client. 

4. Notified bodies shall keep at the disposal of the notifying authority the relevant documents 
concerning the assessment of the qualifications of the subcontractor or the subsidiary and the 
work carried out by them under the relevant TSI. 

Article 32 

Accredited in-house bodies 

1.  The  applicant  undertaking  may  use  an  accredited  in-house  body  to  carry  out  conformity 
assessment activities for the purpose of implementing the procedures set out in modules A1, 
A2,  C1  or  C2  defined  in  Annex  II  to  Decision  768/2008/EC  and  modules  CA1,  and  CA2 
defined  in  Annex  I  to  Decision  2010/713/EC.  That  body  shall  constitute  a  separate  and 
distinct part  of the applicant  undertaking and shall not participate  in  the design, production, 
supply, installation, use or maintenance of the products it assesses. 

2. An accredited in-house body shall meet the following requirements: 

EN 

63 

   EN 

 
(a) it shall be accredited in accordance with Regulation (EC) No 765/2008; 

(b)  the  body  and  its  personnel  shall  be  organisationally  identifiable  and  have  reporting 
methods within the undertaking of which they form a part which ensure their impartiality and 
demonstrate it to the relevant national accreditation body; 

(c) neither the body nor its personnel shall be responsible for the design, manufacture, supply, 
installation, operation or maintenance of the products they assess nor shall they engage in any 
activity that might conflict with their independence of judgment or integrity in relation to their 
assessment activities; 

(d) the body shall supply its services exclusively to the undertaking of which it forms a part. 

3. An accredited in-house body shall not be notified to the Member States or the Commission, 
but  information  concerning  its  accreditation  shall  be  given  by  the  undertaking  of  which  it 
forms a part or by the national accreditation body to the notifying authority at the request of 
that authority. 

Article 33 

Application for notification 

1. A conformity assessment body shall submit an application for notification to the notifying 
authority of the Member State in which it is established. 

2.  That  application  shall  be  accompanied  by  a  description  of  the  conformity  assessment 
activities,  the  conformity  assessment  module  or  modules  and  the  product  or  products  for 
which that body claims to be competent, as well as by an accreditation certificate, where one 
exists, issued by a national accreditation body attesting that the conformity assessment body 
fulfils the requirements laid down in Articles 27 to 29. 

3.  Where  the  conformity  assessment  body  concerned  cannot  provide  an  accreditation 
certificate,  it  shall  provide  the  notifying  authority  with  all  the  documentary  evidence 
necessary for the verification, recognition and regular monitoring of its compliance with the 
requirements laid down in Articles 27 to 29. 

Article 34 

Notification procedure 

1. Notifying authorities may notify only conformity assessment bodies which comply with the 
requirements laid down in Articles 27 to 29. 

2.  They  shall  notify  the  Commission  and  the  other  Member  States  using  the  electronic 
notification tool developed and managed by the Commission. 

3.  The  notification  shall  include  full  details  of  the  conformity  assessment  activities,  the 
conformity  assessment  module  or  modules  and  product  or  products  concerned  and  the 
relevant attestation of competence. 

4.  Where  a  notification  is  not  based  on  an  accreditation  certificate  as  referred  to  in  Article 
33(2), the notifying authority shall provide the Commission and the other Member States with 
documentary evidence which attests to the conformity assessment body’s competence and the 
arrangements in place to ensure that that body will be monitored regularly and will continue 
to satisfy the requirements laid down in Articles 27 to 29. 

5. The body concerned may perform the activities of a notified conformity assessment body 
only  where  no  objections  are  raised  by  the  Commission  or  the  other  Member  States  within 

EN 

64 

   EN 

 
two weeks of a notification where an accreditation certificate is used or within two months of 
a notification where accreditation is not used. 

6. The Commission and the other Member States shall be notified of any subsequent relevant 
changes to the notification. 

Article 35 

Identification numbers and lists of notified conformity assessment bodies 

1. The Commission shall assign an identification number to a notified conformity assessment 
body. 

A notified conformity assessment body shall be assigned a single identification number even 
where it is notified under several Union acts. 

2.  The  Commission  shall  make  publicly  available  the  list  of  the  bodies  notified  under  this 
Directive,  including  the  identification  numbers  that  have  been  allocated  to  them  and  the 
activities for which they have been notified. 

The Commission shall ensure that that list is kept up to date. 

Article 36 

Changes to notifications 

1. Where a notifying authority has ascertained or has been informed that a notified conformity 
assessment body no longer meets the requirements laid down in Articles 27 to 29, or that it is 
failing  to  fulfil  its  obligations,  the  notifying  authority  shall  restrict,  suspend  or  withdraw 
notification  as  appropriate,  depending  on  the  seriousness  of  the  failure  to  meet  those 
requirements or fulfil those obligations. It shall immediately inform the Commission and the 
other Member States accordingly. 

2. In the event of restriction, suspension or withdrawal of notification, or where the notified 
conformity  assessment  body  has  ceased  its  activity,  the  notifying  Member  State  shall  take 
appropriate steps to ensure that the files of that body are either processed by another notified 
conformity  assessment  body  or  kept  available  for  the  responsible  notifying  and  market 
surveillance authorities at their request. 

Article 37 

Challenge of the competence of notified bodies 

1.  The  Commission  shall  investigate  all  cases  where  it  doubts,  or  doubt  is  brought  to  its 
attention,  regarding  the  competence  of  a  notified  conformity  assessment  body  or  the 
continued  fulfilment  by  a  notified  conformity  assessment  body  of  the  requirements  and 
responsibilities to which it is subject. 

2. The notifying Member State shall provide the Commission, on request, with all information 
relating  to  the  basis  for  the  notification  or  the  maintenance  of  the  competence  of  the  body 
concerned. 

3.  The  Commission  shall  ensure  that  all  sensitive  information  obtained  in  the  course  of  its 
investigations is treated confidentially. 

4.  Where  the  Commission  ascertains  that  a  notified  conformity  assessment  body  does  not 
meet  or  no  longer  meets  the  requirements  for  its  notification,  it  shall  inform  the  notifying 

EN 

65 

   EN 

 
Member State accordingly and request it to take the necessary corrective measures, including 
withdrawal of notification if necessary. 

Article 38 

Operational obligations of notified bodies 

1. Notified bodies shall carry out conformity assessments in accordance with the conformity 
assessment procedures provided for in the relevant TSI. 

2.  Conformity  assessments  shall  be  carried  out  in  a  proportionate  manner,  avoiding 
unnecessary  burdens  for  economic  operators.  Conformity  assessment  bodies  shall  perform 
their  activities  taking  due  account  of  the  size  of  an  undertaking,  the  sector  in  which  it 
operates, its structure, the degree of complexity of the product technology in question and the 
mass or serial nature of the production process. 

In  so  doing  they  shall  nevertheless  operate  with  the  aim  of  assessing  the  compliance  of  the 
product with the provisions of this Directive. 

3.  Where  a  notified  conformity  assessment  body  finds  that  requirements  laid  down  in  the 
relevant TSI or corresponding harmonised standards or technical specifications have not been 
met  by  a  manufacturer,  it  shall  require  that  manufacturer  to  take  appropriate  corrective 
measures and shall not issue a conformity certificate. 

4. Where, in the course of the monitoring of conformity following the issue of a certificate, a 
notified conformity assessment body finds that a product no longer complies with the relevant 
TSI  or  corresponding  harmonised  standards  or  technical  specifications,  it  shall  require  the 
manufacturer  to  take  appropriate  corrective  measures  and  shall  suspend  or  withdraw  the 
certificate if necessary. 

5.  Where  corrective  measures  are  not  taken  or  do  not  have  the  required  effect,  the  notified 
conformity  assessment  body  shall  restrict,  suspend  or  withdraw  any  certificates,  as 
appropriate. 

Article 39 

Information obligation on notified bodies 

1. Notified bodies shall inform the notifying authority of the following: 

(a) any refusal, restriction, suspension or withdrawal of a certificate; 

(b) any circumstances affecting the scope of and conditions for notification; 

(c) any request for information which they have received from market surveillance authorities 
regarding conformity assessment activities; 

(d)  on  request,  conformity  assessment  activities  performed  within  the  scope  of  their 
notification  and  any  other  activity  performed,  including  cross-border  activities  and 
subcontracting. 

2.  Notified  bodies  shall  provide  the  other  bodies  notified  under  this  Directive  carrying  out 
similar conformity assessment activities covering the same products with relevant information 
on issues relating to negative and, on request, positive conformity assessment results.  

3.  Notified  bodies  shall  provide  to  the  Agency  the  EC  certificates  of  verification  of 
subsystems,  the  EC  certificates  of  conformity  of  interoperability  constituents  and  the  EC 
certificates of suitability of use of interoperability constituents. 

EN 

66 

   EN 

 
Article 40 

Exchange of experience 

The  Commission  shall  provide  for  the  organisation  of  exchange  of  experience  between  the 
Member States’ national authorities responsible for notification policy. 

Article 41 

Coordination of notified bodies 

The Commission shall ensure that appropriate coordination and cooperation between bodies 
notified under this Directive are put in place and properly operated in the form of a sectoral 
group  of  notified  bodies.  The  Agency  shall  support  the  activities  of  notified  bodies  in 
accordance  with  Article  20  of  Regulation  (EU)  No …/…  [establishing  a  European  railway 
agency]. 

Member  States  shall  ensure  that  the  bodies  notified  by  them  participate  in  the  work  of  that 
group, directly or by means of designated representatives. 

(cid:208) 2008/57/EC 

CHAPTER VII 

COMMITTEE AND WORK PROGRAMME 

Article 31 

Work programme 

1. The Commission shall draw up a work programme taking account of the extension of the 
scope provided for in Article 8, the amendment of the TSIs provided for in Article 6(1) and 
the  other  obligations  imposed  on  it  by  this  Directive.  The  Commission  shall  keep  the 
Committee fully informed on and involved in the drawing up and updating of the programme. 

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

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

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

(c) development 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) identification of the basic parameters for each TSI; 

(f) approval of draft standardisation programmes; 

EN 

67 

   EN 

 
 
 
 
 
 
 
 
(g)  management  of  the  transition  period  between  the  date  of  entry  into  force  of 
Directive  2004/50/EC  and  publication  of  the  TSIs,  including  the  adoption  of  the  reference 
system referred to in Article 36. 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

CHAPTER VIII 

REGISTERS OF NETWORK AND VEHICLES 

Article 4232 

Vehicle numbering system 

1. Any vehicle placed in service in the Community ⌦ Union’s ⌫ rail system shall carry a 
European  vehicle  number  (EVN)  assigned  (cid:214) by  the  national  safety  authority  competent  for 
the  relevant  territory  before  the  first  placing  in  service  of  the  vehicle   when  the  first 
authorisation for placing in service is granted. 

2.  The  applicant  for  the  first  authorisation  shall  be  responsible  for  marking  the  vehicle  in 
question with the EVN assigned to it. 

(cid:208) 2008/57/EC 

The  railway  undertaking  operating  a  vehicle  shall  ensure  the  vehicle  is  marked  with  the 
assigned EVN. 

(cid:216) new 

3. The EVN shall be ⌦ is ⌫ specified in (cid:214) Decision 2007/756/EC  the TSI on operation 
and traffic management. 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

(cid:208) 2008/57/EC 
(cid:214) new 

4. A vehicle shall be assigned an EVN only once, unless otherwise specified in (cid:214) Decision 
2007/756/EC  the TSI on operation and traffic management. 

5.  Notwithstanding  paragraph 1,  in  the  case  of  vehicles  operated  or  intended  to  be  operated 
from  or  to  third  countries  the  track  gauge  of  which  is  different  from  that  of  the  main  rail 
network  within  the  Community  ⌦ Union ⌫,  Member  States  may  accept  vehicles  clearly 
identified according to a different coding system. 

(cid:208) 2008/57/EC (adapted) 

EN 

68 

   EN 

 
 
 
 
 
 
 
(cid:208) 2008/57/EC 
(cid:214) new 

Article 4333 

National vehicle registers 

1. Each Member State shall keep a register of the vehicles authorised (cid:214) placed in service  
in its territory. This register shall meet the following criteria: 

(a) it shall comply with the common specifications referred to in paragraph 2; 

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

(cid:208) 2008/57/EC (adapted) 

(c)  it  shall  be  accessible  to  the  ⌦ national ⌫  safety  authorities  and  investigating 
bodies designated in Articles 16 and 21 of Directive […/… on the safety of the rail 
system within the Union] 2004/49/EC; it shall also be made accessible, in response 
to any legitimate request, to the regulatory bodies designated in Articles 55 and 56 of 
Directive  2012/34/EU  of  the  European  Parliament  and  of  the  Council  of  21 
November 2012 establishing a single European railway area27 Article 30 of Directive 
2001/14/EC,  and  to  the  Agency,  the  railway  undertakings  and  the  infrastructure 
managers, as well as those persons or organisations registering vehicles or identified 
in the register. 

(cid:208) 2008/57/EC 

2. Common specifications for the register shall be adopted in accordance with the regulatory 
procedure referred to in Article 29(3) and on the basis of draft specifications prepared by the 
Agency. Those draft specifications shall include content, data format, functional and technical 
architecture, operating mode, including arrangements for the exchange of data, and rules for 
data input and consultation. 

(cid:216) new 

2. The Commission shall adopt common specifications on content, data format, functional and 
technical architecture, operating mode, including arrangements for the exchange of data, and 
rules  for  data  input  and  consultation  for  the  national  vehicle  registers  by  means  of 
implementing  acts.  Those  implementing  acts  shall  be  adopted  in  accordance  with  the 
examination procedure referred to in Article 48(3)  

For each vehicle, the register shall contain at least the following information: 

(a) the EVN; 

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

(cid:208) 2008/57/EC 

27 

OJ L 343 of 14.12.2012, p. 32. 

EN 

69 

   EN 

 
 
 
 
 
 
 
 
 
 
 
                                                 
(c)  references  to  the  European  register  of  authorised  types  of  vehicles  referred  to  in 

Article 34; 

(d) identification of the owner of the vehicle and the keeper; 

(e) restrictions on how the vehicle may be used; 

(f) the entity in charge of maintenance. 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

3.  The  registration  holder  shall immediately  declare  any  modification  to  the  data  entered  in 
the national vehicle register, the destruction of a vehicle or its decision to no longer register a 
vehicle,  to  the ⌦ national  safety ⌫  authority  of  any  Member  State  where  the  vehicle  has 
been (cid:214) placed in service  authorised. 

(cid:208) 2008/57/EC 
(cid:214) new 

4.  As  long  as  Member  States’  national  vehicle  registers  are  not  linked,  each  Member  State 
shall  update  its  register  with  the  modifications  made  by  another  Member  State  in  its  own 
register, as regards the data with which it is concerned. 

5. In the case of vehicles placed in service for the first time in a third country and authorised 
(cid:214) subsequently placed in service  in a Member State,for placing in service on its territory, 
that Member State shall ensure that the (cid:214) vehicle  data listed in paragraph 2(d) to (f) can be 
retrieved  through  the  national  vehicle  register  (cid:214) or  through  provisions  of  an  international 
agreement   .  Data  referred  to  in  paragraph 2(f)  may  be  substituted  by  safety  critical  data 
relating to the maintenance schedule. 

Article 4434 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

European register of authorised types of vehicles⌦ authorisation to place vehicle types 
on the market ⌫  

(cid:208) 2008/57/EC 
(cid:214) new 

1. The Agency shall set up and keep a register of (cid:214) authorisations to place vehicle types on 
the  market issued  in  accordance  with  Article  22   types  of  vehicles  authorised  by  the 
Member States for placing in service on the Community rail network. This register shall meet 
the following criteria: 

(a) it shall be public and electronically accessible; 

(b) it shall comply with the common specifications referred to in paragraph 34; 

(c) it shall be linked with all national vehicle registers. 

EN 

70 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
(cid:216) new 

2. The  Commission  shall  adopt  common  specifications  relating  to  content,  data  format, 
functional and technical architecture, operating mode and rules for data input and consultation 
for  the  register  of  authorisations  to  place  vehicle  types  on  the  market  by  means  of 
implementing  acts.  Those  implementing  acts  shall  be  adopted  in  accordance  with 
the examination procedure referred to in Article 48(3). 

(cid:208) 2008/57/EC 

2. This register shall include the following details for each type of vehicle: 

(a) the technical characteristics of the type of vehicle, as defined in the relevant TSIs; 

(b) the manufacturer’s name; 

(c)  the  dates,  references  and  Member  States  granting  the  successive  authorisations 
for this type of vehicle, including any restrictions or withdrawals. 

3. When an authorisation of type is granted, modified, suspended or withdrawn in a Member 
State, the national safety authority of this Member State shall inform the Agency, so that the 
latter may update the register. 

4. Common specifications for the register shall be adopted in accordance with the regulatory 
procedure referred to in Article 29(3) and on the basis of draft specifications prepared by the 
Agency. Those draft specifications shall include content, data format, functional and technical 
architecture, operating mode and rules for data input and consultation. 

Article 4535 

Register of infrastructure 

(cid:216) new 

1. 

2. 

3. 

4. 

5. 

6. 

Each Member State shall publish a register of infrastructure stating the values of the 
network parameters of each subsystem or part of subsystem concerned. 

The values of the parameters recorded in the register of infrastructure shall be used in 
combination with the values of the parameters recorded in the vehicle authorisation 
for placing on the market to check the technical compatibility between vehicle and 
network. 

The  register  of  infrastructure  may  stipulate  conditions  for  the  use  of  fixed 
installations and other restrictions. 

Each  Member  State  shall  update  the  register  of  infrastructure  in  accordance  with 
Commission Decision 2011/633/EU. 

Other  registers,  such  as  a  register  on  accessibility,  may  also  be  associated  to  the 
register of infrastructure. 

The Commissionshall adopt common specifications relating to content, data format, 
functional  and  technical  architecture,  operating  mode  and  rules  for  data  input  and 
consultation for the register of infrastructure by means of implementing acts. Those 

EN 

71 

   EN 

 
 
 
 
 
 
 
implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 48(3) 

(cid:208) 2008/57/EC 

1. Each Member State shall ensure that a register of infrastructure is published and updated on 
the basis of the revision cycle referred to in paragraph 2. This register 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 under the applicable TSIs. To that end, each TSI shall 
indicate precisely what information must be included in the register of infrastructure. 

2. The Agency shall prepare draft specifications on this register regarding its presentation and 
format, its revision cycle and instructions for use, taking into account an appropriate transition 
period for infrastructures placed in service before the entry into force of this Directive. The 
Commission  shall  adopt  the  specifications  in  accordance  with  the  regulatory  procedure 
referred to in Article 29(3). 

CHAPTER IX 

TRANSITIONAL PROVISIONS 

Article 36 

Draft reference systems 

1.  The  Agency  shall  develop,  in  accordance  with  Articles 3  and  12  of  Regulation  (EC) 
No 881/2004  and  on  the  basis  of  the  information  notified  by  the  Member  States  under 
Article 17(3) of this Directive, 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 networks and vehicles that will be brought within the 
scope of this Directive, as defined in Article 1 of this Directive. If necessary, the Commission 
shall  adopt  the  reference  system  in  accordance  with  the  regulatory  procedure  referred  to  in 
Article 29(3) of this Directive. 

2. Following adoption of this reference system, Member States shall inform 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) 2008/57/EC (adapted) 

CHAPTER VIIIX 

⌦ TRANSITIONAL AND ⌫ FINAL PROVISIONS 

(cid:216) new 

Article 46 

Exercise of delegation 

EN 

72 

   EN 

 
 
 
 
The  power  to  adopt  delegated  acts  is  conferred  on  the  Commission  subject  to  the 

1. 
conditions laid down in this Article. 

2. 
The  power  to  adopt  delegated  acts  referred  to  in  Articles  4(2)  and  5(3)  shall  be 
conferred on the Commission for an indeterminate period of time from the date of entry into 
force of this Directive. 

3. 
The delegation of power referred to in Articles 4(2) and 5(3) may be revoked at any 
time by the European Parliament or by the Council. A decision of revocation shall put an end 
to the delegation of the power specified in that decision. It shall take effect the day following 
the publication of the decision in the Official Journal of the European Union or at a later date 
specified therein. It shall not affect the validity of any delegated acts already in force. 

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 

4. 
the European Parliament and to the Council. 

5. 
A delegated act adopted pursuant to Articles 4(2) and 5(3) shall enter into force only if 
no  objection  has  been  expressed  either  by  the  European  Parliament  or  the  Council  within  a 
period of two months of notification of that act to the European Parliament and the Council or 
if,  before  the  expiry  of  that  period,  the  European  Parliament  and  the  Council  have  both 
informed  the  Commission  that  they  will  not  object.  That  period  shall  be  extended  by  two 
months at the initiative of the European Parliament or of the Council. 

Article 47 

Urgency procedure  

1.  Delegated  acts  adopted  under  this  Article  shall  enter  into  force  without  delay  and  shall 
apply as long as no objection is expressed in accordance with paragraph 2. The notification of 
a delegated act to the European Parliament and to the Council shall state the reasons for the 
use of the urgency procedure. 

2. Either the European Parliament or the Council may object to a delegated act in accordance 
with the procedure referred to in Article 46(5). In such a case, the Commission shall repeal 
the  act  without  delay  following  the  notification  of  the  decision  to  object  by  the  European 
Parliament or the Council. 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

Article 4829 

Committee procedure 

1. The Commission shall be assisted by the committee established by Article 21 of Directive 
96/48/EC (hereinafter referred to as the Committee). (cid:214) That committee shall be a committee 
within the meaning of Regulation (EU) No 182/2011.   

2.  Where  reference  is  made  to  this  paragraph,  Articles  (cid:214) 4  of  Regulation  (EU)  No 
182/2011  3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of 
Article 8 thereof. 

3.  Where  reference  is  made  to  this  paragraph,  Articles  (cid:214) 5  of  Regulation  (EU)  No 
182/2011  5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of 
Article 8 thereof.  

EN 

73 

   EN 

 
 
4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011 shall 
apply.  

(cid:216) new 

(cid:208) 2008/57/EC 

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. 

5. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of 
Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 

Article 30 

Complementary tasks 

1. The Commission may submit to the Committee any matter relating to the implementation 
of this Directive.  

2. The Committee may discuss any matter relating to the interoperability of the rail system, 
including questions relating to interoperability between the rail system within the Community 
and the rail system of third countries. 

3.  Measures  designed  to  amend  non-essential  elements  of  this  Directive  and  relating  to  the 
adaptation of Annexes II to IX shall be adopted in accordance with the regulatory procedure 
with scrutiny referred to in Article 29(4). 

4. 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. 

(cid:208) 2008/57/EC 
(cid:214) new 

Article 4937 

Motivation 

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 
rail system or any decision taken pursuant to Articles 67, 12, 1114 and 1619 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 law in force in the 
Member State concerned and of the time limits allowed for the exercise of such remedies. 

Article 5039 

Reports and information 

1.  Every  three  years  and  for  the  first  time  (cid:214) three  years  after  the  publication  of  this 
Directive   19 July  2011,  the  Commission  shall  report  to  the  European  Parliament  and  the 
Council  on  the  progress  made  towards  achieving  interoperability  of  the  rail  system.  That 

EN 

74 

   EN 

 
 
 
 
report shall also include an analysis of the cases set out in Article 79 (cid:214) and of the application 
of Chapter V . 

2.  The  Commission  shall,  by  19 July  2013,  publish  a  report  including  an  analysis  of  the 
application of Chapter V and of the improvements in the cross-acceptance of vehicles in the 
Community in terms of length and costs of the procedures for applicants. Where appropriate, 
the  report  shall  also  assess  the  impact  of  various  options  for  further  simplifying  procedures 
relating to the authorisation of vehicles. In this case, several options concerning cooperation 
between national safety authorities and the Agency shall be analysed. 

32. The Agency shall develop and regularly update a tool capable of providing, at the request 
of  a  Member  State  or  the  Commission,  ⌦ an  overview ⌫  a  chart  of  the  interoperability 
level of the rail system. That tool shall use the information included in the registers provided 
for in Chapter VII Articles 33, 34 and 35. 

(cid:208) 2008/57/EC (adapted) 

(cid:216) new 

Article 51 

Transitional regime for placing in service of vehicles 

1.  Member  States  may  continue  to  apply  the  provisions  set  out  in  Chapter  V  of  Directive 
2008/57/EC until [two years after the date of entry into force]. 

2.  Authorisations  for  placing  in  service  of  vehicles  which  have  been  granted  pursuant  to 
paragraph  1,  including  authorisations  delivered  under  international  agreements,  in  particular 
RIC (Regolamento Internazionale Carrozze) and RIV (Regolamento Internazionale Veicoli), 
shall remain valid in accordance with the conditions under which the authorisations have been 
granted. 

3. Vehicles authorised for placing in service pursuant to paragraphs 1 and 2, have to receive a 
vehicle authorisation for placing on the market in order to operate on one or more networks 
not  covered  by  their  authorisation.  The  placing  in  service  on  these  additional  networks  is 
subject to the provisions of Article 21. 

Article 52 

Other transitional provisions 

Annexes  IV,  V,  VI,  VII  and  IX  to  Directive  2008/57/EC  shall  apply  until  the  date  of 
application of the corresponding implementing acts referred to in Articles 8(2), 14(8), 15(7) 
and 7(3) of this Directive. 

Article 53 

Recommendations and opinions and of the Agency 

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

EN 

75 

   EN 

 
 
 
(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

Article 5438 

Transposition 

1.  Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative  provisions 
necessary  to  comply  with  Article  1,  Article 2,  Article 4(2),  Article 5(2),  (5),  (6)  and  (8), 
Article 6(1),  (2),  (3),  (9)  and  (10),  Articles 7,  8,  and  9,  Article 11(4)  and  (5),  Article 12, 
Article 13(5), Articles 15, 16 and 17, Article 18(1), (2), (4) and (5), Article 19(3), Articles 20 
to  27,  Article 28(4)  and  (6),  Articles 32  to  35  (cid:214) Article  1,  Article  2,  Article  7(1)  to  (4), 
Article 11(1), Article 13, Article 14(1) to (7), Article 15(1) to (6), Articles 17 to 21, Article 
22(3) to (7), Articles 23 to 36, Article 37(2), Article 38, Article 39, Articles 41 to 43, Article 
45(1)  to  (5),  Article  51,  and  Annexes I  to  III  by [two  years  after  the  date  of  entry  into 
force]  ⌦ at the latest ⌫ not later than 19 July 2010. They shall forthwith communicate to 
the Commission the text of those measures (cid:214) and a correlation table between those measures 
and this Directive. The correlation tables are needed to enable all actors concerned to clearly 
identify  the  relevant  provisions  applicable  at  national  level  for  the  implementation  of  this 
Directive.   

When Member States adopt those measures, they shall contain a reference to this Directive or 
shall  be  accompanied  by  such  ⌦ a ⌫ reference  at  the  time  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 Directive. Member States shall determine how ⌫ The methods of making 
such reference ⌦ is to be made and how that statement is to be formulated ⌫ shall be laid 
down by the Member States. 

2.  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) 2008/57/EC 

(cid:208) 2008/57/EC (adapted) 

23.  The  obligation  to  transpose  and  implement  ⌦ Article 13,  Article  14(1)  to  (7),  Article 
15(1) to (6), Articles 17 to 21, Article 42, Article 43, Article 45(1) to (5) and Article 51 ⌫ 
Chapters IV, V, VII and VIII of this Directive shall not apply to the Republic of Cyprus and 
the Republic of Malta for as long as no ⌦ rail ⌫ railway system is established within their 
territory. 

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

(cid:208) 2008/57/EC (adapted) 

EN 

76 

   EN 

 
 
 
 
 
Article 5540 

Repeal 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

Directives 96/48/EC and 2001/16/EC 2008/57/EC ⌦ , as amended by the Directives listed in 
Annex IVIX, Part A, is ⌫ shall be repealed with effect from (cid:214) [two years after the date of 
entry  into  force]  19 July  2010,  without  prejudice  to  the  obligations  of  the  Member  States 
concerning ⌦ relating to ⌫ the time limits for ⌦ the ⌫ transposition into national law and 
application of those ⌦ the ⌫ Directives ⌦ set out in Annex IVIX, Part B ⌫ . 

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

Article 14 of Directive 2004/49/EC shall be repealed with effect from 19 July 2008. 

Article 5641 

Entry into force 

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

Articles 3 to 10, Article 11(2), (3) and (4), Article 12, Article 16, shall apply from [two years 
after the date of entry into force].  

(cid:216) new 

(cid:208) 2008/57/EC 

Article 5742 

Addressees 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

EN 

77 

   EN 

 
 
 
 
(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

ANNEX I 

(cid:214) Elements of Union rail system  SCOPE 

1. TRANS-EUROPEAN CONVENTIONAL RAIL SYSTEM 

1.1. Network 

The network of the trans-European conventional rail system will be that on the conventional 
lines of the trans-European transport network identified in Decision No 1692/96/EC. 

For the purposes of this Directive, this ⌦ the Union’s ⌫ network ⌦ shall include ⌫ may 
be subdivided into the following categories: 

– 

– 

– 

– 

– 

– 

– 

– 

– 

⌦ 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,  to  which  the  speed  must  be 
adapted  in  each  case.  This  category  includes  interconnecting  lines  between  high-
speed  and  conventional  networks,  lines  through  stations,  accesses  to  terminals, 
depots, etc. travelled at conventional speed by ‘high-speed’ rolling stock. ⌫ 

⌦ conventional ⌫ lines intended for passenger services, 

⌦ conventional ⌫ lines intended for mixed traffic (passengers and freight), 

⌦ conventional ⌫ lines ⌦ intended ⌫ specially designed or upgraded for freight 
services, 

(cid:208) 2008/57/EC (adapted) 

passenger hubs, 

freight hubs, including intermodal terminals, 

lines connecting the abovementioned elements. 

This  network  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. Vehicles 

(cid:214) For the purposes of this Directive, Union vehicles  The trans-European conventional rail 
system  shall  comprise  all  the  vehicles  likely  to  travel  on  all  or  part  of  the  trans-European 
conventional rail (cid:214) Union’s  network, including: 

(cid:208) 2008/57/EC (adapted) 
(cid:214) new 

EN 

78 

   EN 

 
 
 
 
(cid:216) new 

– 

– 

– 

locomotives and passenger rolling stock, including thermal or electric traction units, 
self-propelling thermal or electric passenger trains, passenger coaches; 

freight wagons, including vehicles designed to carry lorries; 

special vehicles, such as on track machines. 

Each of the above categories may be subdivided into: 

– 

– 

vehicles for international use, 

vehicles for national use. 

The  TSIs  shall  specify  the  requirements  to  ensure  the  safe  operation  of  these  vehicles  on 
different categories of line. 

(cid:208) 2008/57/EC 

high-speed  vehicles  designed  to  operate  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,  

high-speed  vehicles  designed  to  operate  at  speeds  of  the  order  of  200 km/h  on 
specially built or upgraded high-speed lines, where compatible with the performance 
levels of these lines,  

self-propelling thermal or electric trains, 

thermal or electric traction units, 

passenger carriages, 

freight wagons, including vehicles designed to carry lorries. 

– 

– 

– 

– 

– 

– 

Mobile railway infrastructure construction and maintenance equipment may be included. 

Each of the above categories may be subdivided into: 

– 

– 

vehicles for international use, 

vehicles for national use. 

In the case of vehicles designed to operate with a maximum speed lower than 200 km/h and 
likely  to  operate  on  high-speed  lines,  the  TSIs  shall  specify  the  requirements  to  ensure  the 
safe operation of these vehicles on high-speed lines.  

2. TRANS-EUROPEAN HIGH-SPEED RAIL SYSTEM 

2.1. Network 

The network of the trans-European high-speed rail system shall be that of the high-speed lines 
of the trans-European transport network identified in Decision No 1692/96/EC. 

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, 

EN 

79 

   EN 

 
 
 
– 

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

2.2. Vehicles 

The trans-European high-speed rail system shall comprise vehicles 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 2.1, where compatible 
with the performance levels of these lines. 

In addition, vehicles designed to operate with a maximum speed lower than 200 km/h which 
are likely to travel on all or part of the trans-European high-speed network, where compatible 
with  the  performance  levels  of  this  network,  shall  fulfil  the  requirements  ensuring  safe 
operation on this network. To this end, the TSIs for conventional vehicles shall also specify 
requirements for safe operation of conventional vehicles on high-speed networks. 

3. COMPATIBILITY OF THE RAILWAY SYSTEM 

The quality of rail services in Europe depends, inter alia, on excellent compatibility between 
the  characteristics  of  the  network  (in  the  broadest  sense,  i.e.  the  fixed  parts  of  all  the 
subsystems concerned) and those of the vehicles (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 network and vehicles 

The scope of the TSIs shall be progressively extended to the whole rail system as referred to 
in Article 1(4). In order to deliver interoperability cost-effectively further subcategories of all 
categories  of  network  and  vehicles  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, 

benefits to interoperability of an extension of the scope to particular subcategories of 
networks and vehicles, 

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

EN 

80 

   EN 

 
– 

– 

– 

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, 

increase of safety in operation. 

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

EN 

81 

   EN 

 
(cid:208) 2011/18/EU Art. 1 and Annex I 

ANNEX II 

SUBSYSTEMS 

1. List of subsystems 

For  the  purposes  of  this  Directive,  the  system  constituting  the  rail  system  may  be  broken 
down into the following subsystems, either: 

(a) structural areas: 

– 

– 

– 

– 

– 

infrastructure, 

energy, 

trackside control-command and signalling, 

on-board control-command and signalling, 

rolling stock, 

(b) functional areas: 

– 

– 

– 

operation and traffic management, 

maintenance, 

telematics applications for passenger and freight services. 

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 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 the following: 

2.1. Infrastructure 

(cid:208) 2011/18/EU Art. 1 and Annex I 
(adapted) 

The  track,  points,  engineering  structures  (bridges,  tunnels,  etc.),  ⌦ rail-related  station 
components  (including  entrances,  platforms,  zones  of  access,  service  venues,  toilets  and 
information systems, as well as their accessibility features for persons with reduced mobility 
and persons with disabilities) ⌫ associated station infrastructure (platforms, zones of access, 
including the needs of persons with reduced mobility, etc.), safety and protective equipment. 

(cid:208) 2011/18/EU Art. 1 and Annex I 
(adapted) 
(cid:214) new 

2.2. Energy 

The  electrification  system,  including  overhead  lines  and  the  trackside  of  the  electricity 
consumption measuring system. 

EN 

82 

   EN 

 
 
 
 
 
 
2.3. Trackside control-command and signalling 

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

2.4. On-board control-command and signalling 

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

2.5. Operation and traffic management 

The  procedures  and  related  equipment  enabling  coherent  operation  of  the  various  structural 
subsystems,  during  both  normal  and  degraded  operation,  including  in  particular  train 
composition and train driving, traffic planning and management. 

The professional qualifications which may be required for carrying out (cid:214) any type of railway 
service  cross-border services. 

2.6. Telematics applications 

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

(a) applications for passenger services, including systems which provide 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. 

2.7. Rolling stock 

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

2.8. Maintenance 

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

EN 

83 

   EN 

 
 
 
(cid:208) 2008/57/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  authorised  speed.  The 
parameters of brake equipment must guarantee that it is possible to stop within a given brake 
distance at the maximum authorised 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 in a foreseeable manner, 
albeit not in accordance with the posted instructions. 

1.2. Reliability and availability 

The monitoring and maintenance of fixed or movable components that are involved in train 
movements  must  be  organised,  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. 

1.4. Environmental protection 

1.4.1.  The  environmental  impact  of  establishment  and  operation  of  the  rail  system  must  be 
assessed  and  taken  into  account  at  the  design  stage  of  the  system  in  accordance  with  the 
Community ⌦ Union ⌫ provisions in force. 

(cid:208) 2008/57/EC (adapted) 

EN 

84 

   EN 

 
 
 
(cid:208) 2008/57/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. 

1.4.4. Operation of the rail system must respect existing regulations on noise pollution. 

1.4.5.  Operation  of  the  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 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. 

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. 

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

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 and viaducts. 

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). 

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: 

– 

– 

EN 

enable trains to achieve the specified performance levels, 

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

85 

   EN 

 
 
2.3. Control-command and signalling 

2.3.1. Safety 

The control-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 
control-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-command  and  signalling  systems  must  be  tailored  to  the  use  of  those 
systems. 

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

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-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. 

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-command and 
signalling installations. 

EN 

86 

   EN 

 
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 rail system. 

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, taking account of relevant climatic conditions. 

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. 

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. 

2.5.3. Technical compatibility 

The  maintenance  installations  for  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. 

2.6. Operation and traffic management 

2.6.1. Safety 

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 
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 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: 

EN 

87 

   EN 

 
– 

– 

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. 

EN 

88 

   EN 

 
(cid:208) 2008/57/EC 

ANNEX IV 

'EC' DECLARATION OF CONFORMITY AND SUITABILITY FOR USE OF 
INTEROPERABILITY CONSTITUENTS 

1. INTEROPERABILITY CONSTITUENTS 

'EC'  declaration  applies 

The 
the 
interoperability  of  the  rail  system,  as  referred  to  in  Article 3.  These  interoperability 
constituents may be: 

interoperability  constituents 

involved 

the 

in 

to 

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

– 

– 

EN 

the Directive references, 

name  and  address  of  the  manufacturer  or  its  authorised  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), 

89 

   EN 

 
 
– 

– 

– 

– 

– 

– 

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. 

EN 

90 

   EN 

 
(cid:208) 2011/18/EU Art. 1 and Annex II 

ANNEX V 

DECLARATION OF VERIFICATION OF SUBSYSTEMS 

1. 'EC' declaration of verification of subsystems 

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

The  said  declaration  must  be  based  on  the  information  resulting  from  the  'EC'  verification 
procedure for subsystems as defined in Section 2 of Annex VI. It must be written in the same 
language as the technical file and must contain at least the following: 

– 

– 

– 

– 

– 

– 

– 

– 

the Directive references, 

name  and  address  of  the  contracting  entity  or  the  manufacturer,  or  its  authorised 
representative established within the Union (specify the trade name and full address; 
in  the  case  of  the  authorised  representative,  specify  also  the  trade  name  of  the 
contracting entity or the manufacturer), 

(cid:208) 2011/18/EU Art. 1 and Annex II 

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 final 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. 

Where  reference  is  made  in  Annex  VI  to  the  'EC'  ISV  declaration,  the  provisions  of  this 
Section shall apply to this declaration. 

2.Declaration of verification of subsystems in the case of national rules 

Where reference is made in Annex VI to the declaration of verification of subsystems in the 
case  of  national  rules,  the  provisions  of  Section  1  shall  apply  mutatis  mutandis  to  that 
declaration. 

EN 

91 

   EN 

 
 
 
(cid:208) 2011/18/EU Art. 1 and Annex 
III 

ANNEX VI 

VERIFICATION PROCEDURE FOR SUBSYSTEMS 

1. GENERAL PRINCIPLES 

The verification procedure for a subsystem involves checking and certifying that a subsystem: 

– 

– 

is  designed,  constructed  and  installed  in  such  a  way  as  to  meet  the  essential 
requirements concerning it, and 

may be authorised to be placed in service. 

2.‘EC’ VERIFICATION PROCEDURE 

2.1.Introduction 

‘EC’  verification  is  the  procedure  whereby  a  notified  body  checks  and  certifies  that  the 
subsystem: 

– 

– 

complies with the relevant TSI(s), 

complies with the other regulations deriving from the Treaty. 

2.2.Parts of the subsystem and stages 

2.2.1Intermediate statement of verification (ISV) 

If specified in the TSIs or, where appropriate, at the applicant’s request, the subsystem could 
be divided into certain parts or checked at certain stages of the verification procedure. 

The  intermediate  statement  of  verification  (ISV)  is  the  procedure  whereby  a  notified  body 
checks  and  certifies  certain  parts  of  the  subsystem  or  certain  stages  of  the  verification 
procedure. 

Each ISV leads to the issuing of an ‘EC’ ISV certificate by the notified body chosen by the 
applicant,  which  in  turn,  where  applicable,  draws  up  an  ‘EC’  ISV  declaration.  The  ISV 
certificate and ISV declaration must provide reference to the TSIs with which the conformity 
has been assessed. 

2.2.2Parts of the subsystem 

The  applicant  may  apply  for  an  ISV  for  each  part.  And  each  part  shall  be  checked  at  each 
stage as described in Section 2.2.3. 

2.2.3Stages of the verification procedure 

The subsystem, or certain  parts  of the  subsystem, shall be checked at each of the following 
stages: 

– 

– 

– 

overall design, 

production:  construction, 
manufacturing, constituent assembly and overall adjustment, 

including, 

in  particular,  civil-engineering  activities, 

final testing. 

The applicant may apply for an ISV for the design stage (including the type tests) and for the 
production stage. 

EN 

92 

   EN 

 
 
2.3.Certificate of verification 

2.3.1. The notified body responsible for ‘EC’ verification assesses the design, production and 
final testing of the subsystem and draws up the ‘EC’ certificate of verification intended for the 
applicant,  who  in  turn  draws  up  the  ‘EC’  declaration  of  verification.  The  ‘EC’  verification 
certificate must provide reference to the TSIs with which the conformity has been assessed. 

Where a subsystem has not been assessed for its conformity with all relevant TSI(s) (e.g. in 
the case of a derogation, partial application of TSIs for upgrade or renewal, transitional period 
in a TSI or specific case), the ‘EC’ certificate shall give the precise reference to the TSI(s) or 
their  parts  whose  conformity  has  not  been  examined  by  the  notified  body  during  the  ‘EC’ 
verification procedure. 

2.3.2.  Where  ‘EC’  ISV  certificates  have  been  issued  the  notified  body  responsible  for  the 
‘EC’ verification of the subsystem takes these ‘EC’ ISV certificates into account, and, before 
issuing the ‘EC’ certificate of verification, it: 

– 

– 

– 

verifies that the ‘EC’ ISV certificates cover correctly the relevant requirements of the 
TSI(s), 

checks all aspects that are not covered by the ‘EC’ ISV certificate(s), and 

checks the final testing of the subsystem as a whole. 

2.4.Technical file 

The  technical  file  accompanying  the  ‘EC’  declaration  of  verification  must  contain  the 
following: 

– 

– 

– 

– 

– 

technical characteristics linked to the design including general and detailed drawings 
with respect to execution, electrical and hydraulic diagrams, control-circuit diagrams, 
description  of  data-processing  and  automatic  systems,  documentation  on  operation 
and maintenance, etc., relevant for the subsystem concerned, 

list of interoperability constituents, as referred to in Article 5(3)(d), 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, 

where available, the ‘EC’ ISV certificate(s) and, in such a case, where relevant, the 
‘EC’  ISV  declaration(s),  that  accompany  the  ‘EC’  certificate  of  verification, 
including the result of verification by the notified body of the certificates validity, 

‘EC’ certificate of verification, accompanied by corresponding calculation notes and 
signed  by  the  notified  body  responsible  for  the  ‘EC’  verification,  stating  that  the 
subsystem complies with the requirements of the relevant TSI(s) and mentioning any 
reservations  recorded  during  performance  of  the  activities  and  not  withdrawn;  the 
‘EC’  certificate  of  verification  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 2.5.3 and 2.5.4, 

– 

‘EC’ certificates issued in accordance with other legislation deriving from the Treaty, 

EN 

93 

   EN 

 
– 

when  safe  integration  is  required  pursuant  Commission  Regulation  (EC)  No 
352/200931,  the  applicant  shall  include  in  the  technical  file  the  assessor’s  report  on 
the Common Safety Methods (CSM) on risk assessment referred to in Article 6(3) of 
Directive 2004/49/EC. 

2.5.Monitoring 

2.5.1. The aim of ‘EC’ monitoring is to ensure that the obligations deriving from the technical 
file have been met during the production of the subsystem. 

2.5.2. 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 notified body must receive from the applicant all the documents needed for that purpose 
and,  in  particular,  the  implementation  plans  and  technical  documentation  concerning  the 
subsystem. 

2.5.3. The notified body responsible for checking implementation must periodically carry out 
audits  in  order  to  confirm  compliance  with  the  relevant  TSI(s).  It  must  provide  those 
responsible for implementation with an audit report. Its presence may be required at certain 
stages of the building operations. 

2.5.4.  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. 

2.5.5.  With  a  view  to  delivering  the  ‘EC’  declaration  of  suitability  for  use  referred  to  in 
Section 2 of Annex IV, the notified body shall be able to monitor a subsystem on which an 
interoperability  constituent  is  mounted  in  order  to  assess,  where  required  by  the 
corresponding TSI so requires, its suitability for use in its intended railway environment. 

2.6.Submission 

The complete file referred to in paragraph 2.4 must be lodged with the applicant in support of 
the ‘EC’ ISV certificate(s), if available, issued by the notified body responsible for this or in 
support  of  the  certificate  of  verification  issued  by  the  notified  body  responsible  for  ‘EC’ 
verification of the subsystem. The file must be attached to the ‘EC’ declaration of verification 
which the applicant sends to the competent authority with which he lodges the application for 
authorisation for placing in service. 

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

2.7.Publication 

Each notified body must periodically publish relevant information concerning: 

– 

– 

– 

– 

– 

31 

requests for ‘EC’ verification and ISV received, 

request for assessment of conformity and/or suitability for use of ICs, 

‘EC’ ISV certificates issued or refused, 

‘EC’ certificates of conformity and/or suitability for use issued or refused, 

‘EC’ certificates of verification issued or refused. 

OJ L 108, 22.4.2009, p 4. 

EN 

94 

   EN 

 
                                                 
2.8.Language 

The files and correspondence relating to the ‘EC’ verification procedures must be written in 
an EU official language of the Member State in which the applicant is established or in an EU 
official language accepted by the applicant. 

3. VERIFICATION PROCEDURE IN THE CASE OF NATIONAL RULES 

3.1.Introduction 

The  verification  procedure  in  the  case  of  national  rules  is  the  procedure  whereby  the  body 
designated  pursuant  to  Article  17(3)  (the  designated  body)  checks  and  certifies  that  the 
subsystem complies with the national rules notified in accordance with Article 17(3). 

3.2.Certificate of verification 

The  designated  body  responsible  for  the  verification  procedure  in  the  case  of  national  rules 
draws up the certificate of verification intended for the applicant. 

The certificate shall contain a precise reference to the national rule(s) whose conformity has 
been examined by the designated body in the verification process, including those related to 
parts subject to derogation from a TSI, upgrade or renewal. 

In  the  case  of  national  rules  related  to  the  subsystems  composing  a  vehicle,  the  designated 
body  shall  divide  the  certificate  into  two  parts,  one  part  including  the  references  to  those 
national  rules  strictly  related  to  the  technical  compatibility  between  the  vehicle  and  the 
network concerned, and the other part for all other national rules. 

3.3.Technical file 

The  technical  file  accompanying  the  certificate  of  verification  in  the  case  of  national  rules 
must be included in the technical file referred to in point 2.4 and shall contain the technical 
data relevant for the assessment of the conformity of the sub-system with the national rules. 

EN 

95 

   EN 

 
(cid:208) 2008/57/EC 

ANNEX VII 

PARAMETERS  TO  BE  CHECKED  IN  CONJUNCTION  WITH  THE  PLACING  IN 
SERVICE  OF  NON-TSI  CONFORM  VEHICLES  AND 
THE 
CLASSIFICATION OF THE NATIONAL RULES 

(cid:208) 2009/131/EC Art. 1 and Annex  

1. List of parameters 

1.1. General documentation 

General documentation (including description of new, renewed or upgraded vehicle 
and  its  intended  use,  design,  repair,  operation  and  maintenance  information, 
technical file, etc.) 

1.2. Structure and mechanical parts 

Mechanical  integrity  and  interface  between  vehicles  (including  draw  and  buffer 
gear,  gangways),  strength  of  vehicle  structure  and  fittings  (e.g.  seats),  loading 
capability, passive safety (including interior and exterior crashworthiness) 

1.3. Track interaction and gauging 

Mechanical interfaces to the infrastructure (including static and dynamic behaviour, 
clearances and fits, gauge, running gear, etc.) 

1.4. Braking equipment 

Braking-related  items  (including  wheel-slide  protection,  braking  control,  and 
braking performance in service, emergency and parking modes) 

1.5. Passenger-related items 

Passenger  facilities  and  passenger  environment  (including  passenger  windows  and 
doors, requirements for persons with reduced mobility, etc.) 

1.6. Environmental conditions and aerodynamic effects 

Impact  of  the  environment  on  the  vehicle  and  impact  of  the  vehicle  on  the 
environment  (including  aerodynamic  conditions  and  both  the  interface  between  the 
vehicle  and  the  trackside  part  of  the  railway  system  and  the  interface  with  the 
external environment) 

1.7. External warning, marking, functions and software integrity requirements 

External warnings, markings, functions and integrity of software, e.g. safety-related 
functions with an impact on train behaviour including train bus 

1.8. Onboard power supply and control systems 

Onboard  propulsion,  power  and  control  systems,  plus  the  interface  of  the  vehicle 
with the power supply infrastructure and all aspects of electromagnetic compatibility 

1.9. Staff facilities, interfaces and environment 

EN 

96 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Onboard  facilities,  interfaces,  working  conditions  and  environment  for  staff 
(including drivers cabs, driver machine interface) 

1.10. Fire safety and evacuation 

1.11. Servicing 

Onboard facilities and interfaces for servicing 

1.12. Onboard control, command and signalling 

All the onboard equipment necessary to ensure safety and to command and control 
movements  of  trains  authorised  to  travel  on  the  network  and  its  effects  on  the 
trackside part of the railway system 

1.13. Specific operational requirements 

Specific  operational  requirements  for  vehicles  (including  degraded  mode,  vehicle 
recovery etc.) 

1.14. Freight related items 

Freight-specific  requirements  and  environment  (including  facilities  specifically 
required for dangerous goods) 

Explanations and examples in italics above are for information only and are not definitions of 
the parameters. 

(cid:208) 2008/57/EC 

2. Classification of the rules 

The national rules relating to the parameters identified in section 1 shall be attributed to one 
of the following three groups. Rules and restrictions of a strictly local nature are not involved; 
their verification involves checks to be put in place by mutual agreement between the railway 
undertakings and the infrastructure managers. 

Group A 

Group A covers: 

– 

– 

international standards, 

national rules deemed to be equivalent, in railway safety terms, to national rules of 
other Member States. 

Group B 

Group B covers all rules that do not fall within the scope of Group A or Group C, or that it 
has not yet been possible to classify in one of these groups. 

Group C 

Group  C  covers  rules  that  are  strictly  necessary  and  are  associated  with  technical 
infrastructure  characteristics,  in  order  to  ensure  safe  and  interoperable  use  in  the  network 
concerned (e.g. the loading gauge). 

EN 

97 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
ANNEX VIII 

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  authorised  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 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  judgment  or  the  results  of  their  inspection,  in  particular  from  persons  or  groups  of 
persons affected by the results of the checks. 

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  Directive  95/18/EC  and  safety 
certificates  in  the  framework  of  Directive  2004/49/EC,  and  of  the  bodies  in  charge  of 
investigations in the event of accidents. 

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. 

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 and accident investigation bodies in the State where they perform those activities 
as well as accident investigation bodies responsible for the investigation of accidents caused 
by the failure of the interoperability constituents or subsystems checked) in pursuance of this 
Directive or any provision of national law implementing the Directive. 

(cid:208) 2008/57/EC 

ANNEX IX 

FILE FOR SUBMITTING A DEROGATION 

EN 

98 

   EN 

 
 
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(1)(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. 

EN 

99 

   EN 

 
 
 
(cid:208) 2008/57/EC (adapted) 

ANNEX IVX 

PART A 

⌦ Repealed ⌫ Directives 

⌦ with list of the successive amendments thereto ⌫ 

(referred to in Article 5540) 

Directive 96/48/EC 
⌦ 2008/57/EC ⌫  

Directive 2001/16/EC 
⌦ 2009/131/EC ⌫ 

Directive 2004/49/EC 
⌦ 2011/18/EU ⌫ 

⌦ (OJ L 191, 
18.7.2008, 
p.1.) ⌫ 

⌦ (OJ L 273, 
17.10.2009, 
p.12.) ⌫ 

Only Article 14 
⌦ (OJ L 57, 
2.3.2011, 
p.21.) ⌫ 

PART B 

Time limits for transposition into national law 

(referred to in Article 5540) 

Directive 

Deadline for transposition 

96/48/EC 
⌦ 2008/57/
EC ⌫ 

2001/16/EC 
⌦ 2009/131
/EC ⌫ 

2004/49/EC 

⌦ 2011/18/
EU ⌫ 

9 April 1999 ⌦ 19 July 
2010 ⌫  

20 April 2003 ⌦ 19 July 
2010 ⌫ 

30 April 2006 ⌦ 31 
December 2011 ⌫ 

EN 

100 

   EN 

 
 
 
 
(cid:208) 2008/57/EC 

ANNEX XI 

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 1(4) 

Article 2, introductory 
wording 

Article 2, introductory 
wording 

Article 2, introductory 
wording 

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(a) to (b) and (e) to 
(m) 

Article 2(c) and (d) 

Article 2(n) 

Article 2(o) 

Article 2(p) 

Article 2(q) 

Article 2(r) to (z) 

Articles 3, 4 and 5 

Articles 3, 4 and 5 

Articles 3, 4 and 5(1) to (5) 

Article 5(6) 

Article 5(7) 

— 

— 

— 

— 

Article 5(7) 

Article 5(6) 

Article 5(8) 

Article 6(1) to (8) 

Article 6(1) to (8) 

Article 6(1) to (8) 

— 

— 

Article 7 

Article 8 

— 

— 

Article 7 

Article 8 

Article 6(9) to (10) 

Articles 7 and 8 

Article 9 

Article 10(1) 

EN 

101 

   EN 

 
 
Article 9 

Article 9 

Article 10(2) 

Article 10(1) to (3) 

Article 10(1) to (3) 

Article 11(1) to (3) 

— 

— 

Article 10(6) 

— 

Article 11(4) 

Article 11(5) 

Articles 11 to 13 

Articles 11 to 13 

Articles 12 to 14 

Article 14(1) and (2) 

Article 14(1) and (2) 

Article 15(1) and (2) 

Article 14(3) 

Article 14(3) 

Article 20 

Article 14(4) and (5) 

Article 14(4) and (5) 

Article 33 

— 

— 

Article 15(2) and (3) 

Articles 15 and 16 

Articles 15 and 16 

Articles 16 and 17 

Article 16(3) 

Article 16(3) 

Article 17(3) 

— 

— 

— 

Article 18(1) to (3) 

Article 18(1) to (3) 

Article 18(1) to (3) 

— 

Article 19 

Article 20 

— 

— 

Article 19 

Article 20 

— 

Article 18(4) and (5) 

Article 19 

Article 28 

Articles 21 to 27 

Article 21(1) to (3) 

Article 21(1) to (3) 

Article 29(1) to (3) 

— 

— 

Article 21a(1) 

Article 21(4) 

— 

— 

Article 22 

21(4) 

Article 21a(2) 

Article 21a 

Article 21b 

Article 21c 

Article 22 

Article 22a 

— 

Article 21b 

Article 26 

Article 24 

Article 29(4) and (5) 

— 

Article 30(2) 

Article 30(4) 

Article 30(1) 

— 

Article 30(3) 

Article 37 

Articles 34 and 35 

EN 

102 

   EN 

 
— 

— 

— 

Article 23 

Article 24 

— 

Article 25 

Article 26 

— 

Article 23 

Article 25 

Article 27 

Article 28 

— 

Article 29 

Article 30 

Article 32 

Article 31 

Article 36 

Article 38 

Article 39 

Article 40 

Article 41 

Article 42 

Annexes I to VI 

Annexes I to VI 

Annexes I to VI 

— 

— 

Annex VII 

Annex VII 

Annex VII 

Annex VIII 

— 

— 

Annexes IX to XI 

(cid:207) 

ANNEX V 

CORRELATION TABLE 

Directive 2008/57/EC 

This Directive 

Article 1 

Article 1 

Article 2(a) to (z) 

Article 2(1) to (24) 

----- 

Article 3 

Article 4 

Article 2(25) to (41) 

----- 

Article 3 

Article 5(1) to (3)(g) 

Article 4(1) to (3)(g) 

----- 

Article 4(3)(h) and (i) 

EN 

103 

   EN 

 
 
 
Article 5(4) to (8) 

Article 4(4) to (8) 

Article 6 

Article 7 

Article 8 

Article 9 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14 

Article 5 

Article 6 

----- 

Article 7 

Article 8 

Article 9 

----- 

Article 10 

Article 11 

Article 15(1) 

Articles 18(3) and 19(2) 

Article 15(2) and (3) 

----- 

Article 16 

Article 17 

Article 18 

Article 19 

----- 

----- 

----- 

Article 20 

Article 21 

Article 12 

Articles 13 and 14 

Article 15 

Article 16 

Article 17 

Article 18 (except 18(3)) 

Articles 19 and 20 

----- 

Article 21 

104 

EN 

   EN 

 
Articles 22 to 25 

----- 

Article 26 

Article 27 

Article 22 

Article 14(8) 

Article 28 and Annex VIII 

Articles 23 to 41 

Article 29 

Article 48 

Articles 30 and 31 

----- 

Article 32 

Article 33 

Article 34 

Article 35 

Article 36 

----- 

Article 37 

Article 38 

Article 39 

----- 

----- 

Article 40 

Article 41 

Article 42 

Article 42 

Article 43 

Article 44 

Article 45 

----- 

Article 46 and 47 

Article 49 

Article 54 

Article 50 

Articles 51 and 52 

Article 53 

Article 55 

Article 56 

Article 57 

Annex I to III 

Annex I to III 

EN 

105 

   EN 

 
Annex IV 

Article 8(2) 

Annexes V and VI 

Article 15(7) 

Annex VII 

Annex VIII 

Annex IX 

Annex X 

Annex XI 

Article 14(8) 

Articles 27, 28 and 29 

Article 7(3) 

Annex IV 

Annex V 

EN 

106 

   EN