Directive 2008/110/EC of the European Parliament and of the Council of 16 December 2008 amending Directive 2004/49/EC on safety on the Community’s railways (Railway Safety Directive) (Text with EEA relevance)
Date: 2008-12-16
Institutions: Council of the European Union, European Parliament
Subjects: rail transport, technical regulations, trans-European network, transport safety

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DIRECTIVES

DIRECTIVE 2008/110/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 16 December 2008
amending Directive 2004/49/EC on safety on the Community’s railways (Railway Safety Directive)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty
Community, and in particular Article 71(1) thereof,

establishing the European

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and
Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the procedure
Article 251 of the Treaty (2),

laid down in

Whereas:

(1) With a view to pursuing the efforts to create a single
market in rail transport services, the European Parliament
and the Council have adopted Directive 2004/49/EC (3)
establishing a common regulatory framework for railway
safety.

(2)

trans-European high-speed

Originally, authorisation procedures for placing in service
railway vehicles were dealt with by Council Directive
96/48/EC of 23 July 1996 on the interoperability of
the
and
Directive 2001/16/EC of the European Parliament and
of the Council of 19 March 2001 on the interoperability
of the conventional rail system (5) for new or upgraded
system, and Directive
parts of

the Community rail

system (4)

rail

(1) OJ C 256, 27.10.2007, p. 39.
(2) Opinion of the European Parliament of 29 November 2007 (OJ C
297 E, 20.11.2008, p. 133), Council Common Position of 3 March
2008 (OJ C 122 E, 20.5.2008, p. 10) and Position of the European
Parliament of 9 July 2008 (not yet published in the Official Journal).
Council Decision of 1 December 2008.

(3) Directive 2004/49/EC of

the European Parliament and of

the
Council of 29 April 2004 on safety on the Community’s railways
and amending Council Directive 95/18/EC on the licensing of
railway undertakings and Directive 2001/14/EC on the allocation
of railway infrastructure capacity and the levying of charges for
the use of railway infrastructure and safety certification (Railway
Safety Directive)
(OJ L 164, 30.4.2004, p. 44). Corrected by OJ
L 220, 21.6.2004, p. 16.
(4) OJ L 235, 17.9.1996, p. 6.
(5) OJ L 110, 20.4.2001, p. 1.

the

2004/49/EC for vehicles already in use. In accordance
with better regulation, and with a view to simplifying
and modernising Community legislation, all provisions
regarding authorisations for placing railway vehicles in
text.
service should be incorporated in a single legal
Therefore,
of Directive
current Article
2004/49/EC should be deleted and a new provision
regarding authorisation of placing in service vehicles
in Directive
already
in use
2008/57/EC of
the
Council of 17 June 2008 on the interoperability of the
rail system within the Community (recast) (6), (hereinafter
referred to as the ‘Railway Interoperability Directive’), that
has replaced Directives 96/48/EC and 2001/16/EC.

the European Parliament and of

should be

included

14

(3)

(4)

The entry into force of the 1999 Convention concerning
International Carriage by Rail (COTIF) on 1 July 2006
brought in new rules governing contracts for the use of
vehicles. According
to the CUV (Uniform Rules
concerning Contracts of Use of Vehicles in International
Rail Traffic) appended thereto, wagon keepers are no
longer obliged to register their wagons with a railway
‘Regolamento Internazionale
undertaking. The former
Veicoli’
(RIV) Agreement between railway undertakings
has ceased to apply and was partially replaced by a
new private and voluntary agreement (General Contract
of Use for Wagons, GCU) between railway undertakings
and wagon keepers whereby the latter are in charge of
the maintenance of their wagons. In order to reflect these
changes and to facilitate the implementation of Directive
2004/49/EC as far as safety certification of
railway
undertakings is concerned, the concept of the ‘keeper’
‘entity in charge of maintenance’
and the concept of
should be defined, as well as the specification of the
relationship between these entities and railway under­
takings.

The definition of
the keeper should be as close as
possible to the definition used in the 1999 COTIF
Convention. Many entities can be identified as a keeper
of a vehicle, for example, the owner, a company making
business out of a fleet of wagons, a company leasing
vehicles to a railway undertaking, a railway undertaking
or an infrastructure manager using vehicles for main­
taining its infrastructure. These entities have the control
over the vehicle with a view to its use as a means of
transport by the railway undertakings and the infra­
In order to avoid any doubt, the
structure managers.
keeper
should be clearly identified in the National
Vehicle Register (NVR) provided for in Article 33 of
the Railway Interoperability Directive.

(6) OJ L 191, 18.7.2008, p. 1.

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In order to ensure consistency with existing railway legis­
lation and avoid undue burden, Member States should be
allowed to exclude heritage, museum and tourist railways
from the scope of this Directive.

system set up by such entities. As freight wagons are
frequently used in international traffic and as an entity
in charge of maintenance may want to use workshops
established in more than one Member State, the certifi­
cation body should be able to perform its controls in the
whole Community.

(5)

(6)

(7)

Before a vehicle is placed in service or used on the
network, an entity in charge of its maintenance should
be identified in the NVR. A railway undertaking, an infra­
structure manager or a keeper could be an entity in
charge of maintenance.

Member States should be allowed to fulfil the obligations
to identify the entity in charge of maintenance and to
certify it
through alternative measures in the case of
vehicles registered in a third country and maintained
according to the law of
that country, vehicles which
are used on networks or lines the track gauge of which
is different from that of the main rail network within the
Community and for which the requirement to identify an
entity in charge of maintenance is ensured alternatively
by international agreements with third countries and
vehicles used by heritage, museum and tourist railways
or military equipment and special transport requiring an
ad hoc national safety authority permit to be delivered
prior to the service.
In these situations the relevant
Member State should be allowed to accept vehicles on
the network for which it is competent without an entity
in charge of maintenance being assigned to these vehicles
or without such an entity being certified. However, such
derogations should be subject to formal decisions of the
relevant Member State and be analysed by the European
Railway Agency (hereinafter referred to as the ‘Agency’)
in the context of its report on safety performance.

(8) When a railway undertaking or infrastructure manager
uses a vehicle for which no entity in charge of main­
tenance is registered or for which the entity in charge of
maintenance is not certified,
it should control all risks
associated with the use of such a vehicle. The capacity to
control such risks should be demonstrated by the railway
undertaking or the infrastructure manager through the
their safety management system and,
certification of
where applicable,
through their safety certification or
authorisation.

(9)

For freight wagons, the entity in charge of maintenance
should be certified according to a system to be developed
by the Agency and to be adopted by the Commission.
Where the entity in charge of maintenance is a railway
undertaking or an infrastructure manager,
this certifi­
cation should be included in the procedure for safety
certification or authorisation. The certificate delivered to
such an entity would guarantee that the maintenance
requirements of this Directive are met for any freight
wagon of which it is in charge. This certificate should
be valid in the whole Community and should be
the maintenance
delivered by a body able to audit

the Railway Interoperability Directive,

(10) Maintenance requirements are being developed in the
context of
in
particular as part of the ‘rolling stock’ technical specifi­
cations for interoperability (TSIs). As a result of the entry
into force of this Directive there is a need to ensure
coherence between these TSIs and the certification
requirements for the entity in charge of maintenance to
be adopted by the Commission. The Commission will
achieve
the
relevant TSIs using the procedure envisaged by the
Railway Interoperability Directive.

this by modifying, where

appropriate,

(11)

(12)

(13)

Since the objective of
this Directive, namely further
developing and improving safety on the Community’s
railways, cannot be sufficiently achieved by the Member
States and can therefore, by reason of the scale of the
action, be better achieved at Community level,
the
Community may adopt measures,
in accordance with
the principle of subsidiarity as set out in Article 5 of
the Treaty. In accordance with the principle of propor­
tionality, as set out in that Article, this Directive does not
go beyond what is necessary in order to achieve that
objective.

The measures necessary for
the implementation of
Directive 2004/49/EC should be adopted in accordance
with Council Decision 1999/468/EC of 28 June 1999
laying down the procedures for the exercise of imple­
menting powers conferred on the Commission (1).

In particular, the Commission should be empowered to
revise and adapt the Annexes to Directive 2004/49/EC,
to adopt and revise common safety methods and
common safety targets, and also to establish a main­
tenance certification system. Since those measures are
scope and are designed to amend non-
of general
essential elements of Directive 2004/49/EC,
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.

(14) A Member State which has no railway system and which
does not envisage having one in the near future, would
be under a disproportionate and pointless obligation if it
had to transpose and implement this Directive. Therefore,
such a Member State should be exempted, for as long as
it has no railway system,
from the obligation to
transpose and implement this Directive.

(1) OJ L 184, 17.7.1999, p. 23.

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(15)

the Interinstitutional
In accordance with point 34 of
Agreement on better law-making (1), Member States are
encouraged to draw up,
themselves and in the
for
interests of the Community, their own tables illustrating,
as far as possible, the correlation between this Directive
and the transposition measures, and make them public.

(16) Directive 2004/49/EC should therefore be amended

accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Amendments

Directive 2004/49/EC is hereby amended as follows:

1. the following points shall be added to Article 2(2):

‘(d) heritage vehicles

that

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

3.

in Article 4(4) the term ‘wagon keeper’ shall be replaced by
‘keeper’;

4. Article 5(2) shall be replaced by the following:

Before 30 April 2009 Annex I shall be revised,

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

5. Article 6 shall be amended as follows:

(a) paragraph 1 shall be replaced by the following:

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

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

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

2. the following points shall be added to Article 3:

‘(s)

(t)

(u)

“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
in Article 33 of Directive
(NVR) provided for
2008/57/EC of the European Parliament and of the
Council of 17 June 2008 on the interoperability of
the rail system within the Community (recast) (*),
(hereinafter referred to as the “Railway Interoperability
Directive”);

“entity in charge of maintenance” means an entity in
charge of maintenance of a vehicle, and registered as
such in the NVR;

“vehicle” means a railway vehicle suitable for circu­
lation on its own wheels on railway lines, with or
without traction. A vehicle is composed of one or
more structural and functional subsystems or parts
of such subsystems.

___________
(*) OJ L 191, 18.7.2008, p. 1.’;

(1) OJ C 321, 31.12.2003, p. 1.

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

adopted

(b) point

(c) of paragraph 3 shall be replaced by the

following:

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

the structural subsystems of

relevant

with

(c) paragraph 4 shall be replaced by the following:

‘4.
The CSMs shall be revised at regular intervals,
taking into account the experience gained from their
application and the global development of
railway
safety and the obligations on Member States as laid
down in Article 4(1). This measure, designed to
inter
amend non-essential elements of this Directive,
alia, by
adopted in
accordance with
procedure with
scrutiny referred to in Article 27(2a).’;

supplementing

regulatory

shall be

the

it,

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6. Article 7 shall be amended as follows:

(a)

the first and second subparagraphs of paragraph 3 shall
be replaced by the following:

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

shall be

designed

to

It

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

designed

to

(b) paragraph 5 shall be replaced by the following:

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

7. Article 10 shall be amended as follows:

(a)

the second subparagraph of paragraph 1 shall be
replaced by the following:

safety management

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

system and

(b) point

(b) of paragraph 2 shall be replaced by the

following:

‘(b) certification

of

acceptance

confirming

the
provisions adopted by the railway undertaking to
meet specific requirements necessary for the safe
supply of
its services on the relevant network.
These requirements may concern the application
of the TSIs and national safety rules, including the
network operating rules, acceptance of staff certi­
ficates and authorisation to operate vehicles used by
railway undertakings. The certification shall be
based on documentation submitted by the railway
undertaking as described in Annex IV.’;

8. the following Article shall be inserted:

‘Article 14a

Maintenance of vehicles

1.
Each vehicle, before it is placed in service or used on
the network, shall have an entity in charge of maintenance
assigned to it and this entity shall be registered in the NVR
in accordance with Article 33 of the Railway Interoper­
ability Directive.

A railway undertaking, an infrastructure manager or a

2.
keeper may be an entity in charge of maintenance.

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

the vehicles for which it

for

(a)

the maintenance file of each vehicle;

(b) the requirements in force including maintenance rules

and TSI provisions.

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

4.
In the case of freight wagons, each entity in charge of
maintenance shall be certified by a body accredited or
recognised in accordance with paragraph 5, or by a
national safety authority. The accreditation process shall
independence, competence and
be based on criteria of
impartiality,
the relevant EN 45 000 series
European standards. The recognition process shall also be
based on criteria of independence, competence and impar­
tiality.

such as

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Where the entity in charge of maintenance is a railway
undertaking or an infrastructure manager, compliance
with the requirements to be adopted under paragraph 5
shall be checked by the relevant national safety authority
pursuant to the procedures referred to in Articles 10 or 11
and shall be confirmed on the certificates specified in those
procedures.

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

The measure shall include the requirements concerning:

(a)

the maintenance system established by the entity;

(b) the format and validity of the certificate granted to the

entity;

(c)

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

(d) the date of application of

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

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

recommendation by

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

the Agency,

(a) vehicles registered in a third country and maintained

according to the law of that country;

(b) vehicles which are used on networks or lines the track
gauge of which is different from that of the main rail
and for which
network within the Community
fulfilment
in
referred
requirements
the
paragraph 3 are ensured by international agreements
with third countries;

to

of

(c) vehicles

identified

in Article 2(2),

and military
equipment and special transport requiring an ad hoc
national safety authority permit to be delivered prior
to the service. In this case derogations shall be granted
for periods not longer than five years.

Such alternative measures shall be implemented through
derogations to be granted by the relevant national safety
authority:

(a) when registering vehicles pursuant to Article 33 of the
Railway Interoperability Directive, as far as the identifi­
cation of
the entity in charge of maintenance is
concerned;

(b) when delivering safety certificates and authorisations to
railway undertakings
infrastructure managers
and
pursuant to Articles 10 and 11 of this Directive, as
far as the identification or certification of the entity
in charge of maintenance is concerned.

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

The certificates granted in accordance with paragraph

6.
5 shall be valid throughout the Community.

9. Article 16(2) shall be amended as follows:

in

The Agency shall evaluate the certification process
paragraph 5 by
to the Commission, no later than
the relevant

the entry into force of

7.
implemented
submitting a report
three years after
measure.

accordance with

8. Member States may decide to fulfil the obligations to
identify the entity in charge of maintenance and to certify it
through alternative measures, in the following cases:

(a) point (a) shall be replaced by the following:

constituting

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

rail

the

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(b) point (b) shall be deleted;

(c) point (g) shall be replaced by the following:

‘(g) supervising that vehicles are duly registered in the
NVR and that safety related information contained
therein, is accurate and kept up to date;’;

10. the following point shall be added to Article 18:

‘(e)

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

11. Article 26 shall be replaced by the following:

‘Article 26

Adaptation of the Annexes

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

12. Article 27 shall be amended as follows:

(a)

the following paragraph shall be inserted:

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

apply, having

to (4)

(b) paragraph 4 shall be deleted;

13. point 3 of Annex II shall be deleted.

Article 2

Implementation and transposition

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 24 December 2010. They shall forthwith commu­
nicate to the Commission the text of those provisions.

When Member States adopt these measures, they shall contain a
reference to this Directive or shall be accompanied by such
reference on the occasion of
their official publication. The
methods of making such reference shall be laid down by the
Member States.

The obligations for transposition and implementation of this
Directive shall not apply to the Republic of Cyprus and the
Republic of Malta for as long as no railway system is established
within their respective territories.

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.

Article 3

Entry into force

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

Article 4

Addressees

This Directive is addressed to the Member States.

Done at Strasbourg, 16 December 2008.

For the European Parliament
The President

H.-G. PÖTTERING

For the Council
The President

B. LE MAIRE