HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 320/8
EN
Official Journal of the European Union
17.11.2012
COMMISSION REGULATION (EU) No 1078/2012
of 16 November 2012
on a common safety method for monitoring to be applied by railway undertakings, infrastructure
managers after receiving a safety certificate or safety authorisation and by entities in charge of
maintenance
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) This
Regulation
should
enable
the
effective
management
of safety of the railway system during its operation and
Having regard to the Treaty on the Functioning of the European
maintenance activities and, where necessary and
Union,
reasonably practicable, should improve the management
system.
Having regard to 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
(5)
This Regulation should also enable to identify as early as
95/18/EC on the licensing of railway undertakings and
possible non-compliance in applying a management
Directive 2001/14/EC on the allocation of railway infrastructure
system in ways that may result in accidents, incidents,
capacity and the levying of charges for the use of railway infra
near-misses or other dangerous occurrences. To manage
structure and safety certification (Railway Safety Directive) ( 1 ),
these forms of non-compliance during operation and
and in particular Article 6 thereof,
maintenance activities a harmonised process for moni
toring activities should be used. In particular that
Whereas:
harmonised process should be used to check the
achievement of the expected outcome of the safety
(1) The
Commission
should
adopt
the
second
series
of
management systems of railway undertakings and infra
common safety methods (CSM) covering at least the
structure managers, and check the achievement of the
methods provided for in Article 6(3)(c) of Directive
expected outcome of the system of maintenance of the
2004/49/EC, on the basis of a recommendation of the
entities in charge of maintenance.
European Railway Agency (the ‘Agency’).
(2) On
5
October
2009
the
Commission
issued
a
mandate (6) The
railway
undertakings
and
infrastructure
managers
to the Agency in accordance with Directive 2004/49/EC
should monitor the correct application and the
to draw up a draft CSM for checking conformity of
outcomes of the arrangements they have developed
operation and maintenance of structural subsystems
through their safety management system so as to
with relevant essential requirements. This CSM should
operate safely, including on specific networks.
specify the methods to be used both to check that the
structural sub-systems (including traffic operation and
management) are operated and maintained in accordance
(7) This
Regulation
should
facilitate
access
to
the
market
for
with all essential requirements related to safety and to
rail transport services through harmonisation of the
monitor that the sub-systems and their integration in the
monitoring process to ensure the continuous
systems continue to fulfil their safety requirements when
achievement of the safety performance of the railway
operated and maintained. The Agency submitted its
system. In addition, this Regulation should help to
recommendation on the CSM to the Commission,
create mutual trust and transparency between Member
supported by an impact assessment report to address
States, through a harmonised exchange of safety-related
the mandate of the Commission. This Regulation is
information between different actors involved within the
based on the recommendation by the Agency.
railway sector in order to manage safety across the
different interfaces of this sector and harmonised
(3) To
enable
the
safe
integration,
operation
and
main
evidence from the application of the monitoring process.
tenance of structural sub-systems within the railway
system, and to ensure that essential requirements are
met in operation, safety management systems of
(8) To
report
to
the
Commission
on
the
effectiveness
and
railway undertakings and infrastructure managers, and
application of this Regulation, and where applicable to
systems of maintenance of entities in charge of main
make recommendations to improve it, the Agency
tenance should include all necessary arrangements,
should be able to gather relevant information from the
including processes, procedures, technical, operational
various involved actors, including from the national
and organisational risk control measures. Consequently,
safety authorities, from the certification bodies of
monitoring the correct application and effectiveness of
entities in charge of maintenance of freight wagons and
safety management systems of railway undertakings and
from other entities in charge of maintenance that do not
infrastructure managers, as well as of systems of main
fall under the scope of Commission Regulation (EU) No
tenance of entities in charge of maintenance, should
445/2011 of 10 May 2011 on a system of certification
cover the requirements for structural sub-systems
of entities in charge of maintenance for freight
within their operational context.
wagons ( 2 ).
( 1 ) OJ L 164, 30.4.2004, p. 44.
( 2 ) OJ L 122, 11.5.2011, p. 22.

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EN
17.11.2012 Official
Journal
of
the
European
Union
L
320/9
(9) The
measures
provided
for
in
this
Regulation
are
in
Article 3
accordance with the opinion of the Committee referred
to in Article 27(1) of Directive 2004/49/EC,
Monitoring process
1. Each
railway
undertaking,
infrastructure
manager
and
HAS ADOPTED THIS REGULATION:
entity in charge of maintenance:
Article 1
(a) shall be responsible for conducting the monitoring process
Subject matter and scope
set out in the Annex;
1. This
Regulation
establishes
a
common
safety
method
(CSM) for monitoring, enabling the effective management of
(b) shall ensure that risk control measures implemented by their
safety in the railway system during its operation and main
contractors are also monitored in compliance with this
tenance activities and, where appropriate, improving the
Regulation. To this end, they shall apply the monitoring
management system.
process set out in the Annex or require their contractors
to apply this process through contractual arrangements.
2. This
Regulation
shall
be
used
for
the
following:
2. The
monitoring
process
shall
contain
the
following
activ
(a) to check the correct application and the effectiveness of all
ities:
the processes and procedures in the management system,
including the technical, operational and organisational risk
(a) the definition of a strategy, priorities and plan(s) for moni
control measures. In case of railway undertakings and infra
toring;
structure managers, checking will include the technical,
operational and organisational elements that are necessary
for the issue of the certification/authorisation specified in
(b) the collection and analysis of information;
Article 10(2)(a) and 11(1)(a) and the provisions adopted
to obtain the certification/authorisation specified in
(c) the drawing up of an action plan for instances of
Article 10(2)(b) and 11(1)(b) of Directive 2004/49/EC;
unacceptable non-compliance with requirements laid down
in the management system;
(b) to check the correct application of the management system
as a whole, and if the management system achieves the
expected outcomes; and
(d) the implementation of the action plan, if such a plan is
drawn up;
(c) to identify and implement appropriate preventive, corrective
or both types of measures if any relevant instance of non-
(e) the evaluation of the effectiveness of action plan measures,
compliance to points (a) and (b) is detected.
if such a plan is drawn up.
3. This
Regulation
shall
apply
to
railway
undertakings,
infra
Article 4
structure managers after receiving a safety certificate or safety
authorisation and entities in charge of maintenance.
Exchange of information between the involved actors
1. Railway
undertakings,
infrastructure
managers
and
entities
Article 2
in charge of maintenance, including their contractors, shall
Definitions
ensure through contractual arrangements that any relevant
safety-related information resulting from applying the moni
For the purposes of this Regulation the definitions of Article 3
toring process set out in the Annex is exchanged between
of Directive 2004/49/EC shall apply.
them, to enable the other party to take any necessary corrective
actions to ensure continuous achievement of the safety
In addition, the following definitions shall apply:
performance of the railway system.
(a) ‘management system’ means either the safety management
systems of railway undertakings and infrastructure
2. If, through the application of the monitoring process,
managers, as defined in Article 3(i) of Directive 2004/49/EC
railway undertakings, infrastructure managers and entities in
and complying with requirements laid down in Article 9
charge of maintenance identify any relevant safety risk as
and Annex III of that Directive, or the system of main
regards defects and construction non-conformities or
tenance of entities in charge of maintenance complying
malfunctions of technical equipment, including those of
with requirements laid down in Article 14a(3) of that
structural sub-systems, they shall report those risks to the
Directive;
other parties involved to enable them to take any necessary
corrective actions to ensure continuous achievement of the
(b) ‘monitoring’ means the arrangements put in place by
safety performance of the railway system.
railway undertakings, infrastructure managers or entities in
charge of maintenance to check their management system is
Article 5
correctly applied and effective;
Reporting
(c) ‘interfaces’ means interfaces as defined in Article 3(7) of
1. The
infrastructure
managers
and
railway
undertakings
Commission Regulation (EC) No 352/2009 ( 1 ).
shall report to the national safety authority on the application
of this Regulation through their annual safety reports in
( 1 ) OJ L 108, 29.4.2009, p. 4.
accordance with Article 9(4) of Directive 2004/49/EC.

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L 320/10
EN
Official Journal of the European Union
17.11.2012
2. The
national
safety
authority
shall
report
on
the
appli
shall make recommendations to the Commission with a
cation of this Regulation by the railway undertakings, infra
view to improving this Regulation.
structure managers, and as far as it is aware of it, by the
entities in charge of maintenance in accordance with Article 18
6. The
national
safety
authorities
shall
support
the
Agency
in
of Directive 2004/49/EC.
collecting such information from railway undertakings and
infrastructure managers.
3. The annual maintenance report of entities in charge of
maintenance of freight wagons set out in point I.7.4(k) of
7. The
Agency
shall
submit
to
the
Commission
not
later
Annex III to Regulation (EU) No 445/2011, shall include
than three years after the entry into force of this Regulation a
information about the experience of entities in charge of main
report analysing the effectiveness of the method and of the
tenance in applying this Regulation. The Agency shall gather
experience of railway undertakings, infrastructure managers
this information in coordination with the respective certification
and entities in charge of maintenance in applying this Regu
bodies.
lation.
4. The
other
entities
in
charge
of
maintenance
that
do
not
Article 6
fall under the scope of Regulation (EU) No 445/2011 shall also
share their experience with the Agency on the application of
Entry into force and application
this Regulation. The Agency shall coordinate the sharing of
This Regulation shall enter into force on the twentieth day
experience with these entities in charge of maintenance.
following that of its publication in the Official Journal of the
European Union.
5. The
Agency
shall
collect
all
information
on
the
experience
of the application of this Regulation and, when necessary,
This Regulation shall apply from 7 June 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 November 2012.
For the Commission
The President
José Manuel BARROSO

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EN
17.11.2012 Official
Journal
of
the
European
Union L
320/11
ANNEX
THE MONITORING PROCESS
1. General
1.1. The inputs to the monitoring process shall be all the processes and procedures contained in the management system,
including technical, operational and organisational risk control measures.
1.2. The activities referred in Article 3(2) of the monitoring process are described in Sections 2 to 6.
1.3. This monitoring process is repetitive and iterative, as shown in the diagram below in the Appendix.
2. Definition of a strategy, priorities and plan(s) for monitoring
2.1. Based on their management system, each railway undertaking, infrastructure manager and entity in charge of
maintenance shall be responsible for defining its strategy, priorities and plan(s) for monitoring.
2.2. The decision on what to prioritise shall take into account information from areas that give rise to the greatest risks
and, if not monitored effectively, could lead to adverse consequences for safety. An order of priority for monitoring
activities shall be set, and the time, effort and resources required shall be indicated. Prioritisation shall also take into
account results from previous applications of the monitoring process.
2.3. The monitoring process shall identify as early as possible instances of non-compliance in the application of the
management system that might result in accidents, incidents, near-misses or other dangerous occurrences. It shall
lead to the implementation of measures to remedy such instances of non-compliance.
2.4. The monitoring strategy and plan(s) shall define either quantitative or qualitative indicators or a mixture of both that
can:
(a) give early warnings of any deviation from the expected outcome, or assurance that the expected outcome is
achieved as planned;
(b) give information about unwanted outcomes;
(c) support decision making.
3. Collection
and
analysis
of
information
3.1. The collection and analysis of information shall be carried out according to the strategy, priorities and plan(s) defined
for the monitoring.
3.2. For each defined indicator referred to in point 2.4, the following shall be carried out:
(a) a collection of necessary information;
(b) an evaluation as to whether the processes, procedures, technical, operational and organisational risk control
measures are correctly implemented;
(c) a check on whether the processes, procedures, technical, operational and organisational risk control measures are
effective and whether they achieve the expected outcomes;
(d) an evaluation of whether the management system as a whole is correctly applied and whether it achieves the
expected outcomes;
(e) an analysis and evaluation of instances of identified non-compliance with points (b), (c) and (d), as well as
identification of their causes.
4. Drawing
up
of
an
action
plan
4.1. For identified instances of non-compliance that are considered unacceptable, an action plan shall be drawn up. This
shall:
(a) lead to the enforcement of correctly implemented processes, procedures, technical, operational and organisational
risk control measures as specified; or
(b) improve existing processes, procedures, technical, operational and organisational risk control measures; or
(c) identify and implement additional risk control measures.
4.2. The action plan shall in particular include the following information:
(a) objectives and results expected;

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L 320/12
EN
Official Journal of the European Union
17.11.2012
(b) corrective, preventive or both types of measures required;
(c) person responsible for implementing actions;
(d) dates by which actions are to be implemented;
(e) person responsible for evaluating the effectiveness of the action plan measures in accordance with Section 6;
(f) a review of the impact of the action plan on the monitoring strategy, priorities and plan(s).
4.3. For managing safety at interfaces the railway undertaking, infrastructure manager or entity in charge of maintenance
shall decide, in agreement with the other actors involved, who shall be in charge of implementing the required action
plan or parts of it.
5. Implementation
of
the
action
plan
5.1. The action plan defined in Section 4 shall be implemented so as to correct identified instances of non-compliance.
6. Evaluation of the effectiveness of the action plan measures
6.1. Correct implementation, appropriateness and effectiveness of measures identified in the action plan shall be checked
using the same monitoring process as described in this Annex.
6.2. Evaluation of the action plan’s effectiveness shall in particular include the following actions:
(a) verification of whether the action plan is correctly implemented and completed according to schedule;
(b) verification of whether the expected outcome is achieved;
(c) verification of whether in the meantime the initial conditions have changed and the risk control measures
defined in the action plan are still appropriate for the given circumstances;
(d) verification of whether other risk control measures are necessary.
7. Evidence from the application of the monitoring process
7.1. The monitoring process shall be documented to prove it has been applied correctly. This documentation shall be
made available primarily for internal assessment purposes. Upon request:
(a) railway undertakings and infrastructure managers shall make this documentation available to the national safety
authority;
(b) entities in charge of maintenance shall make this documentation available to the certification body. If interfaces
are managed through contracts, the entities in charge of maintenance shall make this documentation available to
the respective railway undertakings and infrastructure managers.
7.2. The documentation produced under point 7.1 shall include in particular:
(a) a description of the organisation and staff appointed to carry out the monitoring process;
(b) the results of the different activities of the monitoring process listed in Article 3(2) and in particular the decisions
made;
(c) in the case of instances of identified non-compliance that are considered unacceptable, a list of all necessary
measures to be implemented to achieve the required outcome.

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EN
17.11.2012 Official
Journal
of
the
European
Union L
320/13
Appendix
Framework for the monitoring process

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Document Outline

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