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17.11.2012 Official
Journal
of
the
European
Union
L
320/3
COMMISSION REGULATION (EU) No 1077/2012
of 16 November 2012
on a common safety method for supervision by national safety authorities after issuing a safety
certificate or safety authorisation
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
lishes the principles to be observed by national safety
authorities during supervision as defined in that Regu
lation after issuing a safety certificate.
Having regard to the Treaty on the Functioning of the European
Union,
(4) Commission
Regulation
(EU)
No
1169/2010
of
10 December 2010 on a common safety method for
assessing conformity with the requirements for
Having regard to Directive 2004/49/EC of the European
obtaining a railway safety authorisation ( 3 ) includes all
Parliament and of the Council of 29 April 2004 on safety on
the harmonised requirements and assessment methods
the Community’s railways and amending Council Directive
by means of which national safety authorities can issue
95/18/EC on the licensing of railway undertakings and
an infrastructure manager with a safety authorisation
Directive 2001/14/EC on the allocation of railway infrastructure
under Article 11 of Directive 2004/49/EC covering the
capacity and the levying of charges for the use of railway infra
adequacy of the safety management system in general
structure and safety certification ( 1 ) and in particular Article 6
and any network-specific authorisation. That Regulation
thereof,
also defines the criteria against which assessment by
national safety authorities must be carried out,
describes the procedures to follow and establishes the
Whereas:
principles to be used by national safety authorities
during supervision, as defined in that Regulation, after
issuing a safety authorisation.
(1) One of the purposes of Directive 2004/49/EC is to
improve access to the market for rail transport services
by defining common principles for the management,
(5)
After issuing a safety certificate or a safety authorisation,
regulation and supervision of railway safety. Directive
the national safety authority must put in place
2004/49/EC also provides equal treatment for all
arrangements to check whether the results outlined in
railway undertakings by applying the same safety certifi
the application for a safety certificate or a safety auth
cation requirements throughout the European Union.
orisation are being achieved during operation and that all
the necessary requirements are complied with on a
continuous basis, as required by Article 16(2)(e) and
Article 17(2) of Directive 2004/49/EC.
(2) On
5
October
2009
the
Commission
issued
a
mandate
to the European Railway Agency (‘the Agency’) in
accordance with Directive 2004/49/EC to draw up a
(6)
To be able to perform its tasks under Article 16(2)(f) of
draft common safety method (CSM) for supervision by
Directive 2004/49/EC, the national safety authority also
national safety authorities after issuing a safety certificate
needs to judge, based on its supervision activities, the
or a safety authorisation to railway undertakings and
effectiveness of the safety regulatory framework. ‘Super
infrastructure managers. The Agency submitted its
vision’ means the arrangements put in place by the
recommendation on the CSM to the Commission,
national safety authority to oversee safety performance
supported by an impact assessment report, in
after it has granted a safety certificate or safety authori
agreement with the mandate of the Commission. This
sation.
Regulation is based on the recommendation by the
Agency.
(7) In
undertaking
supervision,
the
national
safety
authority
must apply the fundamental principles of national safety
(3) Commission
Regulation
(EU)
No
1158/2010
of
authority supervision activity — proportionality,
9 December 2010 on a common safety method for
consistency, targeting, transparency, accountability and
assessing conformity with the requirements for
cooperation — as set out in Regulation (EU) No
obtaining railway safety certificates
( 2 ) provides a
1158/2010 and in Regulation (EU) No 1169/2010.
method for assessing conformity with requirements for
However, these principles also need a framework and
obtaining safety certificates to be issued in accordance
process to apply them in practice in the day-to-day
with Article 10(2)(a) and Article 10(2)(b) of Directive
activities of the national safety authorities. The current
2004/49/EC. That Regulation defines the criteria against
Regulation would provide the necessary framework and
which assessment by national safety authorities must be
process to the national safety authorities, while
carried out, describes the procedures to follow and estab
improving the mutual trust in their approaches to, and
decision-making during supervision activities.
( 1 ) OJ L 164, 30.4.2004, p. 44.
( 2 ) OJ L 326, 10.12.2010, p. 11.
( 3 ) OJ L 327, 11.12.2010, p. 13.

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L 320/4
EN
Official Journal of the European Union
17.11.2012
(8) The
measures
provided
for
in
this
Regulation
are
in 3. The
national
safety
authority
shall
regularly
review
the
accordance with the opinion of the Committee estab
strategy and plan or plans in the light of experience, using
lished in accordance with Article 27(1) of Directive
the information collected and the outcomes of supervision.
2004/49/EC,
Article 4
HAS ADOPTED THIS REGULATION:
Techniques for conducting supervision
1. The
national
safety
authority
shall
adopt
techniques
for
supervision activities. These techniques commonly include
Article 1
interviews with people at various levels in an organisation,
Subject matter and scope
reviewing documents and records related to the safety
management system and examining the safety outcomes of
1. This
Regulation
establishes
a
common
safety
method the management system revealed by inspections or related activ
(CSM) of supervision of the safety performance after issuing a
ities.
safety certificate for railway undertakings or a safety authori
sation for infrastructure managers as referred to in Annex IV to
Regulation (EU) No 1158/2010 and Annex III to Regulation
2. The
national
safety
authority
shall
ensure
that
its
super
(EU) No 1169/2010 respectively.
vision activities include checking
2. National
safety
authorities
shall
apply
the
common
safety (a) the effectiveness of the safety management system;
method to oversee compliance with the legal obligation on a
railway undertaking or infrastructure manager to use a safety
management system to ensure the control of all risks associated
(b) the effectiveness of individual or partial elements of the
with their activities including the supply of maintenance and
safety management system, including operational activities.
material and the use of contractors and, where appropriate, to
check the application of Commission Regulation (EU) No
1078/2012 of 16 November 2012 on a common safety
Article 5
method for monitoring to be applied by railway undertakings,
Links between assessment and supervision
infrastructure managers after receiving a safety certificate or
safety authorisation and by entities in charge of maintenance ( 1 ).
1. The
national
safety
authority
shall
use
information
gathered during the assessment of a railway undertaking’s or
infrastructure manager’s safety management system for the
3. National
safety
authorities
shall
use
this
Regulation
to purposes of its supervision of the continued application of
perform their supervision activities under Article 16(2)(f) of
their safety management system after issuing the safety
Directive 2004/49/EC and to advise the Member States on the
certificate or the safety authorisation.
effectiveness of the safety regulatory framework.
2. The
national
safety
authority
shall
also
use
information
gathered during its supervision activities for reassessing a
Article 2
railway undertaking’s or an infrastructure manager’s safety
Definitions
management system prior to the renewal of a safety certificate
or safety authorisation.
For the purposes of this Regulation, ‘supervision’ has the
meaning provided for by Article 2 of Regulation (EU) No
1158/2010 and Article 2 of Regulation (EU) No 1169/2010.
Article 6
Competence of the persons involved in supervision
activities
Article 3
The national safety authority shall have a system in place to
Supervision strategy and plan(s)
ensure that supervision activities are undertaken by competent
persons.
1. The
national
safety
authority
shall
develop
and
implement
a supervision strategy and plan(s) outlining how it targets its
activities and sets its priorities for supervision as set out in the
Annex.
Article 7
Decision-making criteria
1. The
national
safety
authority
shall
establish
and
publish
2. The
national
safety
authority
shall
collect
and
analyse decision-making criteria on how it monitors, promotes and
information from a variety of sources. It shall use the
where appropriate enforces compliance with the safety regu
information collected and the outcomes of supervision for the
latory framework. These criteria shall also include non-
purposes set out in Article 1.
compliance issues related to the continued application of a
safety management system by a railway undertaking or infra
( 1 ) See page 8 of this Official Journal.
structure manager and to the safety regulatory framework.

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EN
17.11.2012 Official
Journal
of
the
European
Union
L
320/5
2. The
national
safety
authority
shall
adopt
and
publish
a orities concerned, including any relevant outcomes, to enable a
procedure to enable railway undertakings and infrastructure
joint approach to dealing with non-compliance.
managers to submit a complaint on decisions taken during
supervision activities, without prejudice to the requirement for
a judicial review of those decisions.
2. National
safety
authorities
shall
develop
cooperation
arrangements with national investigation bodies, certification
bodies for entities in charge of maintenance and other
Article 8
competent authorities in order to share information and to
coordinate their response to any failure to comply with the
Coordination and cooperation
safety-related regulatory framework.
1. National
safety
authorities
involved
in
the
supervision
of
a
railway undertaking operating in more than one Member State
Article 9
shall coordinate their approach to supervision to ensure that the
safety management system of the railway undertaking is
Entry into force and application
effective and covers all relevant activities. The coordination
This Regulation shall enter into force on the twentieth day
activities shall involve agreement on what information to
following its publication in the Official Journal of the European
share between national safety authorities in order to ensure a
Union.
common approach to supervision of the relevant railway under
taking. It shall also include sharing information on the super
vision strategy and plan or plans of the national safety auth
It 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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L 320/6
EN
Official Journal of the European Union
17.11.2012
ANNEX
Supervision activities
1. Setting up the supervision strategy and plan(s)
The national safety authority shall:
(a) identify areas for targeted supervision activities;
(b) develop a supervision plan or plans showing how it will give effect to the supervision strategy during the lifecycle
of a valid safety certificate/safety authorisation;
(c) produce an initial estimate of resources required to give effect to the plan or plans, based on the target areas
identified;
(d) allocate resources to give effect to the plan or plans;
(e) use data/information from a variety of sources as an input to the strategy and the plan or plans. Sources could
include information gathered during the assessment of safety management systems, outcomes of previous super
vision activities, information from authorisations to bring subsystems or vehicles into service, national investi
gation bodies accident reports/recommendations, other accident/incident reports or data, a railway undertaking’s or
an infrastructure manager’s annual reports to the national safety authority, annual maintenance reports from
entities in charge of maintenance, complaints from members of the public and other relevant sources.
2. Communicating the supervision strategy and plan(s)
The national safety authority shall:
(a) communicate the overall objectives of the supervision strategy and overall explanation of the plan or plans to
relevant railway undertakings or infrastructure managers and, where appropriate, more widely to other stake
holders;
(b) provide relevant railway undertakings or infrastructure managers with an overall explanation on how the super
vision plan or plans will be undertaken.
3. Carrying out the supervision strategy and plan(s)
The national safety authority shall:
(a) execute the plan or plans as foreseen;
(b) take proportionate action to deal with failure to comply, including issuing any urgent safety alerts when necessary;
(c) evaluate how adequately a railway undertaking or an infrastructure manager has developed and implemented an
action plan or plans to remedy any non-compliance identified by the national safety authority within a specified
time period.
4. Outcomes of supervision plan(s)
The national safety authority shall:
(a) share results with the relevant railway undertaking or infrastructure manager of the effectiveness of their safety
management system in delivering safe performance, including identifying areas of non-compliance on the part of
the infrastructure manager or railway undertaking;
(b) have an overview of the safety performance of the individual railway undertakings or infrastructure managers
operating in its Member State;
(c) publish and communicate to relevant stakeholders its views on the overall safety performance in the Member State;
(d) publish and communicate to relevant stakeholders its views on the effectiveness of the safety regulatory
framework.
5. Reviewing supervision activities
On the basis of experience gathered during supervision activities, the national safety authority shall at regular intervals:
(a) conduct a review of the plan or plans to check that the original targeted activity, use of data/information from a
variety of sources, supervision outcomes and resource allocation are appropriate, changing priorities as necessary;
(b) make any necessary changes to the plan or plans if they are to be revised and consider the impact of the changes
on the supervision strategy;

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EN
17.11.2012 Official
Journal
of
the
European
Union
L
320/7
(c) contribute when necessary with its views and any proposals to its Member State to overcome any deficiencies in
the safety regulatory framework.

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Document Outline

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