HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 121/8
EN
Official Journal of the European Union
3.5.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 402/2013
of 30 April 2013
on the common safety method for risk evaluation and assessment and repealing Regulation (EC) No
352/2009
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Commission, supported by an impact assessment report
to address the mandate of the Commission. This Regu
lation is based on that Agency recommendation.
Having regard to the Treaty on the Functioning of the European
Union,
(3) In
accordance
with
Directive
2004/49/EC
the
basic
elements for the safety management system should
Having regard to Directive 2004/49/EC of the European
include procedures and methods for carrying out risk
Parliament and of the Council of 29 April 2004 on safety on
evaluation and implementing risk control measures
the Community’s railways and amending Council Directive
whenever a change in operating conditions or new
95/18/EC on the licensing of railway undertakings and
material imposes new risks on the infrastructure or on
Directive 2001/14/EC on the allocation of railway infrastructure
operations. That basic element of the safety management
capacity and the levying of charges for the use of railway infra
system is covered by this Regulation.
structure and safety certification (Railway Safety Directive) ( 1 ),
and in particular Article 6(4) thereof,
(4) Article
14a(3)
of
Directive
2004/49/EC
requires
entities
in charge of maintenance to establish a system of main
Whereas:
tenance in order to ensure that the vehicles for which
they are in charge of maintenance are in a safe state of
running. To manage changes in equipment, procedures,
(1) In
accordance
with
Directive
2004/49/EC,
common
organisation, staffing or interfaces, the entities in charge
safety methods (CSMs) should be gradually introduced
of maintenance should have in place risk assessment
to ensure that a high level of safety is maintained and,
procedures. That requirement for the system of main
when and where necessary and reasonably practicable,
tenance is also covered by this Regulation.
improved.
(5)
As a consequence of the application of Council Directive
(2) On
12
October
2010
the
Commission
issued
a
mandate
91/440/EEC of 29 July 1991 on the development of the
to the European Railway Agency (the ‘Agency’) in
Community’s railways ( 3 ) and of Article 9(2) of Directive
accordance with Directive 2004/49/EC to revise
2004/49/EC, particular attention should be paid to risk
Commission Regulation (EC) No 352/2009 of 24 April
management at the interfaces between the actors which
2009 on the adoption of a common safety method on
are involved in the application of this Regulation.
risk evaluation and assessment as referred to in
Article 6(3)(a) of Directive 2004/49/EC of the European
Parliament and of the Council ( 2 ). The revision should
cover the results of the analysis by the Agency under
(6)
Article 15 of Directive 2008/57/EC of the European
Article 9(4) of the Regulation of the overall effectiveness
Parliament and of the Council of 17 June 2008 on the
of the CSM for risk evaluation and assessment and
interoperability of the rail system within the Commu
experience with its application as well as further devel
nity ( 4 ) requires Member States to take all appropriate
opments in the roles and the responsibilities of the
steps to ensure that the structural subsystems consti
assessment body referred to in Article 6 of that Regu
tuting the rail system may be placed in service only if
lation. The revision should also include the qualification
they are designed, constructed and installed in such a
requirements (by developing a recognition/accreditation
way as to meet the essential requirements concerning
scheme) for the assessment body according to its role
them when integrated into the rail system. In particular,
in the CSM, with a view to improving clarity in order
the Member States must check the technical compatibility
to avoid differences in application across the Member
of these subsystems with the railway system into which
States, taking into account the interfaces with existing
they are being integrated and the safe integration of these
Union authorisation/certification procedures in the
subsystems in accordance with the scope of this Regu
railway sector. If feasible, the revision of Regulation
lation.
(EC) No 352/2009 should also cover further devel
opments in risk acceptance criteria that could be used
to assess the acceptability of a risk during explicit risk
(7) The
absence
of
a
common
approach
for
specifying
and
estimation and evaluation. The Agency submitted its
demonstrating compliance with safety levels and
recommendation on the revision of the CSM to the
requirements of the railway system among the Member
( 1 ) OJ L 164, 30.4.2004, p. 44.
( 3 ) OJ L 237, 24.8.1991, p. 25.
( 2 ) OJ L 108, 29.4.2009, p. 4.
( 4 ) OJ L 191, 18.7.2008, p. 1.

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States has proved to be one of the obstacles to liberali
been used successfully in a number of railway appli
sation of the railway market. Such a common approach
cations, as well as in other transport modes and other
should be established through this Regulation.
industries. The ‘explicit risk estimation’ principle is
frequently used for complex or innovative changes. The
proposer should be responsible for the choice of the
principle to apply.
(8) To
facilitate
mutual
recognition
between
Member
States,
the methods used for identifying and managing risks and
the methods for demonstrating that the railway system in
the territory of the Union conforms to safety
(12) When
a
widely
recognised
code
of
practice
is
applied,
it
requirements should be harmonised among the actors
should therefore be possible to reduce the impact of
involved in the development and operation of the
applying the CSM, in accordance with the principle of
railway system. As a first step, it is necessary to
proportionality. In the same way, where there are
harmonise the procedures and methods for carrying
provisions at the level of the Union which require
out risk evaluation and implementing control measures
specific intervention by the national safety authority,
whenever a change in operating conditions or new
that authority should be allowed to act as the inde
material imposes new risks on the infrastructure or on
pendent assessment body in order to reduce double
operations, as referred to in point (2)(d) of Annex III to
checking, undue costs to the industry and time to
Directive 2004/49/EC.
market.
(9)
If there is no existing notified national rule for defining
(13) To
report
to
the
Commission
on
the
effectiveness
and
whether or not a change is significant for the safety in a
application of this Regulation, and where applicable to
Member State, the company or organisation in charge of
make recommendations to improve it, the Agency
implementing the change (the ‘proposer’) should initially
should be able to gather relevant information from the
consider the potential impact of the change in question
various actors involved, including from the national
on the safety of the railway system. If the proposed
safety authorities, from the certification bodies of
change has an impact on safety, the proposer should
entities in charge of maintenance of freight wagons and
assess, by expert judgement, the significance of the
from other entities in charge of maintenance that do not
change based on a set of criteria that should be set out
fall within the scope of Commission Regulation (EU) No
in this Regulation. This assessment should lead to one of
445/2011 of 10 May 2011 on a system of certification
three conclusions. In the first situation the change is not
of entities in charge of maintenance for freight
considered to be significant and the proposer should
wagons ( 1 ).
implement the change by applying its own safety
method. In the second situation the change is considered
to be significant and the proposer should implement the
change by applying this Regulation, without the need for
(14) Accreditation
of
an
assessment
body
should
normally
be
a specific intervention of the national safety authority. In
granted by the national accreditation body which has
the third situation the change is considered to be
exclusive competence to assess if the assessment body
significant but there are provisions at the level of the
meets the requirements set by harmonised standards.
European Union which require a specific intervention
Regulation (EC) No 765/2008 of the European
of the relevant national safety authority, such as a new
Parliament and of the Council of 9 July 2008 setting
authorisation for placing in service of a vehicle or a
out the requirements for accreditation and market
revision/update of the safety certificate of a railway
surveillance relating to the marketing of products ( 2 )
undertaking or a revision/update of the safety authori
contains detailed provisions on the competence of such
sation of an infrastructure manager.
national accreditation bodies.
(10) Whenever
the
railway
system
already
in
use
is
subject
to
(15) Where
harmonised
Union
legislation
provides
for
the
a change, the significance of the change should also be
selection of conformity assessment bodies for its imple
assessed taking into account all safety-related changes
mentation, transparent accreditation, as provided for in
affecting the same part of the system since the entry
Regulation (EC) No 765/2008, should be considered by
into force of this Regulation or since the last application
the national public authorities throughout the Union as
of the risk management process set out in this Regu
the preferred means of demonstrating the technical
lation, whichever is the latest. The purpose is to assess
competence of those bodies. However, national auth
whether or not the totality of such changes amounts to a
orities may consider that they possess the appropriate
significant change requiring the full application of the
means to carry out this evaluation themselves. In such
CSM for risk evaluation and assessment.
cases, the Member State should provide the Commission
and the other Member States with all the documentary
evidence necessary for verification of the competence of
the recognition body it selects for implementation of the
(11) The
risk
acceptability
of
a
significant
change
should
be
Union legislation. In order to achieve a similar level of
evaluated by using one or more of the following risk
quality and trust as expected through accreditation, the
acceptance principles: the application of codes of
practice, a comparison with similar parts of the railway
( 1 ) OJ L 122, 11.5.2011, p. 22.
system, or an explicit risk estimation. All principles have
( 2 ) OJ L 218, 13.8.2008, p. 30.

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Official Journal of the European Union
3.5.2013
requirements and rules for the evaluation and
(b) the exchange of safety-relevant information between
surveillance of assessment bodies in the case of recog
different actors within the rail sector in order to manage
nition should be equivalent to those used for accredi
safety across the different interfaces which may exist within
tation.
this sector;
(16) An
independent
and
competent
external
or
internal
indi
(c) the evidence resulting from the application of a risk
vidual, organisation or entity, a national safety authority,
management process.
a notified body or a body designated according to
Article 17 of Directive 2008/57/EC could act as an
assessment body provided it fulfils the criteria required
Article 2
in Annex II.
Scope
1. This
Regulation
shall
apply
to
the
proposer
as
defined
in
(17) Recognition
of
internal
assessment
bodies
in
compliance
Article 3(11) when making any change to the railway system in
with this Regulation does not require an immediate
a Member State.
revision of already delivered safety certificates to
railway undertakings, safety authorisations to infra
structure managers and certificates to entities in charge
Such changes may be of a technical, operational or organisa
of maintenance. Their revision can be made at the next
tional nature. As regards organisational changes, only those
application for renewal or update of the safety certificate,
changes which could impact the operational or maintenance
safety authorisation or certificate of the entity in charge
processes shall be subjected to consideration under the rules
of maintenance.
of Article 4.
(18) In
existing
legislation
there
are
no
limits
in
the
number
2. When, on the basis of an assessment under the criteria set
of assessment bodies accredited or recognised in each
out in Article 4(2)(a) to (f):
Member State and there are no obligations to have at
least one. Where the assessment body is not already
(a) the change is considered significant, the risk management
designated by existing Union or national legislation, the
process set out in Article 5 shall be applied;
proposer may appoint any assessment body in the Union
or in a third country accredited under equivalent criteria
and meeting equivalent requirements to those contained
(b) the change is considered not significant, keeping adequate
in this regulation. The Member State should be able to
documentation to justify the decision shall be sufficient.
use accreditation or recognition or any combination of
these two options.
3. This
Regulation
shall
apply
also
to
structural
sub-systems
to which Directive 2008/57/EC applies:
(19) Regulation
(EC)
No
352/2009
has
become
obsolete
and
should therefore be replaced by this Regulation.
(a) if a risk assessment is required by the relevant technical
specification for interoperability (TSI); in this case the TSI
(20) In
view
of
the
new
requirements
introduced
by
the
shall, where appropriate, specify which parts of this Regu
present Regulation in terms of accreditation and recog
lation apply;
nition of the assessment body, the implementation of
this Regulation should be deferred in order to give
(b) if the change is significant as set out in Article 4(2), the risk
sufficient time to the actors concerned to put in place
management process set out in Article 5 shall be applied
and implement this new common approach.
within the placing in service of structural sub-systems to
ensure their safe integration into an existing system, by
(21) The
measures
provided
for
in
this
Regulation
are
in
virtue of Article 15(1) of Directive 2008/57/EC.
accordance with the opinion of the Committee estab
lished in accordance with Article 27(1) of Directive
4. The
application
of
this
Regulation
in
the
case
referred
to
2004/49/EC,
in paragraph 3(b) of this Article shall not lead to requirements
contradictory to those laid down in the relevant TSIs. If such
HAS ADOPTED THIS REGULATION:
contradictions occur, the proposer shall inform the Member
State concerned which may then decide to ask for a revision
Article 1
of the TSI in accordance with Article 6(2) or Article 7 of
Directive 2008/57/EC or a derogation in accordance with
Subject matter
Article 9(2) of that Directive.
1. This
Regulation
establishes
a
revised
common
safety
method (CSM) for risk evaluation and assessment as referred
5. The
railway
systems
excluded
from
the
scope
of
Directive
to in Article 6(3)(a) of Directive 2004/49/EC.
2004/49/EC according to its Article 2(2) are excluded from the
scope of this Regulation.
2. This
Regulation
shall
facilitate
the
access
to
the
market
for
rail transport services through harmonisation of:
6. The
provisions
of
Regulation
(EC)
No
352/2009
shall
continue to apply in relation to projects which are at an
(a) the risk management processes used to assess the impact of
advanced stage of development within the meaning of
changes on safety levels and compliance with safety require
Article 2(t) of Directive 2008/57/EC at the date of application
ments;
of this Regulation.

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Article 3
(12) ‘safety assessment report’ means the document containing
the conclusions of the assessment performed by an
Definitions
assessment body on the system under assessment;
For the purpose of this Regulation the definitions in Article 3 of
Directive 2004/49/EC apply.
(13) ‘hazard’ means a condition that could lead to an accident;
The following definitions also apply:
(14) ‘assessment body’ means the independent and competent
external or internal individual, organisation or entity which
(1) ‘risk’ means the frequency of occurrence of accidents and
undertakes investigation to provide a judgement, based on
incidents resulting in harm (caused by a hazard) and the
evidence, of the suitability of a system to fulfil its safety
degree of severity of that harm;
requirements;
(2) ‘risk analysis’ means systematic use of all available
(15) ‘risk acceptance criteria’ means the terms of reference by
information to identify hazards and to estimate the risk;
which the acceptability of a specific risk is assessed; these
criteria are used to determine that the level of a risk is
(3) ‘risk evaluation’ means a procedure based on the risk
sufficiently low that it is not necessary to take any
analysis to determine whether an acceptable level of risk
immediate action to reduce it further;
has been achieved;
(16) ‘hazard record’ means the document in which identified
(4) ‘risk assessment’ means the overall process comprising a
hazards, their related measures, their origin and the
risk analysis and a risk evaluation;
reference to the organisation which has to manage them
are recorded and referenced;
(5) ‘safety’ means freedom from unacceptable risk of harm;
(17) ‘hazard identification’ means the process of finding, listing
and characterising hazards;
(6) ‘risk management’ means the systematic application of
management policies, procedures and practices to the
(18) ‘risk acceptance principle’ means the rules used in order to
tasks of analysing, evaluating and controlling risks;
arrive at the conclusion whether or not the risk related to
one or more specific hazards is acceptable;
(7) ‘interfaces’ means all points of interaction during a system
or subsystem life cycle, including operation and main
(19) ‘code of practice’ means a written set of rules that, when
tenance where different actors of the rail sector will
correctly applied, can be used to control one or more
work together in order to manage the risks;
specific hazards;
(8) ‘actors’ means all parties which are, directly or through
(20) ‘reference system’ means a system proven in use to have
contractual arrangements, involved in the application of
an acceptable safety level and against which the accepta
this Regulation;
bility of the risks from a system under assessment can be
evaluated by comparison;
(9) ‘safety requirements’ means the safety characteristics (quali
tative or quantitative) of a system and its operation
(21) ‘risk estimation’ means the process used to produce a
(including operational rules) and maintenance necessary
measure of the level of risks being analysed, consisting
in order to meet legal or company safety targets;
of the following steps: estimation of frequency,
consequence analysis and their integration;
(10) ‘safety measures’ means a set of actions either reducing the
frequency of occurrence of a hazard or mitigating its
(22) ‘technical system’ means a product or an assembly of
consequences in order to achieve and/or maintain an
products including the design, implementation and
acceptable level of risk;
support documentation; the development of a technical
system starts with its requirements specification and ends
(11) ‘proposer’ means one of the following:
with its acceptance; although the design of relevant
interfaces with human behaviour is considered, human
(a) a railway undertaking or an infrastructure manager
operators and their actions are not included in a
which implements risk control measures in accordance
technical system; the maintenance process is described in
with Article 4 of Directive 2004/49/EC;
the maintenance manuals but is not itself part of the
technical system;
(b) an entity in charge of maintenance which implements
measures in accordance with Article 14a(3) of
(23) ‘catastrophic consequence’ means fatalities and/or multiple
Directive 2004/49/EC;
severe injuries and/or major damage to the environment
resulting from an accident;
(c) a contracting entity or a manufacturer which invites a
notified body to apply the ‘EC’ verification procedure
(24) ‘safety acceptance’ means status given to the change by the
in accordance with Article 18(1) of Directive
proposer based on the safety assessment report provided
2008/57/EC or a designated body according to
by the assessment body;
Article 17(3) of that Directive;
(25) ‘system’ means any part of the railway system which is
(d) an applicant for an authorisation for the placing in
subjected to a change whereby the change may be of a
service of structural sub-systems;
technical, operational or organisational nature;

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Official Journal of the European Union
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(26) ‘notified national rule’ means any national rule notified by
3. The
proposer
shall
keep
adequate
documentation
to
justify
Member States under Council Directive 96/48/EC ( 1 ) or,
its decision.
Directive 2001/16/EC of the European Parliament and of
the Council
( 2 ) and Directives 2004/49/EC and
Article 5
2008/57/EC;
Risk management process
(27) ‘certification body’ means a certification body as defined in
1. The
proposer
shall
be
responsible
for
applying
this
Regu
Article 3 of Regulation (EU) No 445/2011;
lation, including the assessment of the significance of the
change based on the criteria in Article 4, and for conducting
(28) ‘conformity assessment body’ means a conformity
the risk management process set out in Annex I.
assessment body as defined in Article 2 of Regulation
(EC) No 765/2008;
2. The
proposer
shall
ensure
that
risks
introduced
by
its
(29) ‘accreditation’ means accreditation as defined in Article 2
suppliers and its service providers, including their subcon
of Regulation (EC) No 765/2008;
tractors, are also managed in compliance with this Regulation.
To this end, the proposer may require through contractual
(30) ‘national accreditation body’ means a national accreditation
arrangements that its suppliers and its service providers,
body as defined in Article 2 of Regulation (EC) No
including their subcontractors, participate in the risk
765/2008;
management process set out in Annex I.
(31) ‘recognition’ means an attestation by a national body other
Article 6
than the national accreditation body that the assessment
body meets the requirements set out in Annex II to this
Independent assessment
Regulation to carry out the independent assessment
1. An
assessment
body
shall
carry
out
an
independent
activity specified in Article 6(1) and (2).
assessment of the suitability of both the application of the
risk management process as set out in Annex I and of its
Article 4
results. This assessment body shall meet the criteria listed in
Significant changes
Annex II. Where the assessment body is not already designated
by existing Union or national legislation, the proposer shall
1. If
there
is
no
notified
national
rule
for
defining
whether
a appoint its own assessment body at the earliest appropriate
change is significant or not in a Member State, the proposer
stage of the risk assessment process.
shall consider the potential impact of the change in question on
the safety of the railway system.
2. To perform the independent assessment, the assessment
body shall:
If the proposed change has no impact on safety, the risk
management process described in Article 5 need not be applied.
(a) ensure it has a thorough understanding of the significant
change based on the documentation provided by the
2. If
the
proposed
change
has
an
impact
on
safety,
the
proposer;
proposer shall decide, by expert judgement, on the significance
of the change based on the following criteria:
(b) conduct an assessment of the processes used for managing
(a) failure consequence: credible worst-case scenario in the
safety and quality during the design and implementation of
event of failure of the system under assessment, taking
the significant change, if those processes are not already
into account the existence of safety barriers outside the
certified by a relevant conformity assessment body;
system under assessment;
(c) conduct an assessment of the application of those safety and
(b) novelty used in implementing the change: this concerns
quality processes during the design and implementation of
both what is innovative in the railway sector, and what is
the significant change.
new for the organisation implementing the change;
Having completed its assessment in accordance with points (a),
(c) complexity of the change;
(b) and (c), the assessment body shall deliver the safety
assessment report provided for in Article 15 and Annex III.
(d) monitoring: the inability to monitor the implemented
change throughout the system life-cycle and intervene
appropriately;
3. Duplication
of
work
between
the
following
assessments
shall be avoided:
(e) reversibility: the inability to revert to the system before the
change;
(a) the assessment of conformity of the safety management
system and of the system of maintenance of entities in
(f) additionality: assessment of the significance of the change
charge of maintenance as required by Directive 2004/49/EC;
taking into account all recent safety-related changes to the
and
system under assessment and which were not judged to be
significant.
(b) the conformity assessment carried out by a notified body as
defined by Article 2(j) of Directive 2008/57/EC or a body
( 1 ) OJ L 235, 17.9.1996, p. 6.
designated in accordance with Article 17 of that Directive;
( 2 ) OJ L 110, 20.4.2001, p. 1.
and

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(c) any independent assessment carried out by the assessment
Article 7, as proof of the ability of the railway undertaking or
body in accordance with this Regulation.
infrastructure manager to act as an assessment body.
4. Without
prejudice
to
Union
legislation,
the
proposer
may
choose the national safety authority as assessment body where
2. When
granting
the
certificate
to
an
entity
in
charge
of
that national safety authority offers this service and where the
maintenance in accordance with Regulation (EU) No
significant changes concern the following cases:
445/2011, the certification body shall accept such accreditation
or recognition by a Member State, as proof of the ability of the
(a) a vehicle needs an authorisation for placing in service, as
entity in charge of maintenance to act as assessment body.
referred to in Articles 22(2) and 24(2) of Directive
2008/57/EC;
Article 9
(b) a vehicle needs an additional authorisation for placing in
Types of recognition of the assessment body
service, as referred to in Articles 23(5) and 25(4) of
Directive 2008/57/EC;
1. The following types of recognition of the assessment body
may be used:
(c) the safety certificate has to be updated due to alteration of
the type or extent of the operation, as referred to in
Article 10(5) of Directive 2004/49/EC;
(a) recognition by the Member State of an entity in charge of
maintenance, an organisation or a part of it or an indi
(d) the safety certificate has to be revised due to substantial
vidual;
changes to the safety regulatory framework, as referred to
in Article 10(5) of Directive 2004/49/EC;
(b) recognition by the national safety authority of the ability of
(e) the safety authorisation has to be updated due to substantial
an organisation or a part of it or an individual to conduct
changes to the infrastructure, signalling or energy supply, or
independent assessment through the assessment and super
to the principles of their operation and maintenance, as
vision of the safety management system of a railway under
referred to in Article 11(2) of Directive 2004/49/EC;
taking or an infrastructure manager;
(f) the safety authorisation has to be revised due to substantial
changes to the safety regulatory framework, as referred to in
(c) when the national safety authority is acting as certification
Article 11(2) of Directive 2004/49/EC.
body in conformity with Article 10 of Regulation (EU) No
445/2011, recognition by the national safety authority of
Where a significant change concerns a structural subsystem that
the ability of an organisation or a part of it or an individual
needs an authorisation for placing in service as referred to in
to conduct independent assessment through assessment and
Article 15(1) or Article 20 of Directive 2008/57/EC, the
surveillance of the system of maintenance of an entity in
proposer may choose the national safety authority as
charge of maintenance;
assessment body, where that national safety authority offers
this service, unless the proposer has already given that task to
a notified body in accordance with Article 18(2) of that
(d) recognition by a recognition body designated by the
Directive.
Member State of the ability of an entity in charge of main
tenance, an organisation or a part of it or an individual to
Article 7
conduct independent assessment.
Accreditation/recognition of the assessment body
2. When the Member State recognises the national safety
The assessment body provided for in Article 6 shall be either:
authority as an assessment body, it is the responsibility of
that Member State to ensure that the national safety authority
(a) accredited by the national accreditation body referred to in
fulfills the requirements set out in Annex II; In this case, the
Article 13(1) using the criteria defined in Annex II; or
assessment body functions of the national safety authority shall
be demonstrably independent of the other functions of the
(b) recognised by the recognition body referred to in
national safety authority.
Article 13(1) using the criteria defined in Annex II; or
(c) the national safety authority under the requirement of
Article 10
Article 9(2).
Validity of recognition
Article 8
1. In
the
cases
referred
in
Article
9(1)(a)
and
(d)
and
Acceptance of accreditation/recognition
Article 9(2), the period of validity of recognition shall not
exceed 5 years from the date it is granted.
1. When granting the safety certificate or the safety auth
orisation in accordance with Commission Regulation (EU) No
1158/2010 ( 1 ) or Commission Regulation (EU) No
2. In
the
case
referred
in
Article
9(1)(b):
1169/2010 ( 2 ), a national safety authority shall accept accredi
tation or recognition by a Member State in accordance with
(a) the statement of recognition for a railway undertaking or an
( 1 ) OJ L 326, 10.12.2010, p. 11.
infrastructure manager shall be displayed on the relevant
( 2 ) OJ L 327, 11.12.2010, p. 13.
safety certificate in field 5 ‘Additional Information’ of the

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harmonised format of safety certificates provided in Annex I
shall also notify any change to that situation within one month
to Commission Regulation (EC) No 653/2007 ( 1 ) and in an
of the change. The Agency shall make this information publicly
appropriate part of the safety authorisations;
available.
(b) the period of validity of recognition shall be limited to the
2. By
no
later
than
21
May
2015,
the
national
accreditation
validity of the safety certificate or authorisation under which
body shall inform the Agency of the assessment bodies
it is granted. In this case, the request of recognition shall be
accredited, as well as of the area of competence for which
made at the next application for renewal or update of the
those assessment bodies are accredited as provided for in
safety certificate or authorisation.
points 2 and 3 of Annex II. They shall also notify any
change to that situation within 1 month of the change. The
Agency shall make this information publicly available.
3. In
the
cases
referred
in
Article
9(1)(c):
3. By
no
later
than
21
May
2015,
the
recognition
body
shall
(a) the statement of recognition for an entity in charge of
inform the Agency of the assessment bodies recognised, as well
maintenance shall be displayed on the relevant certificate
as of the area of competence for which those assessment bodies
in field 5 ‘Additional Information’ of the harmonised
are recognised as provided for in points 2 and 3 of Annex II.
format of certificates for entities in charge of maintenance
They shall also notify any change to that situation within 1
provided in Annex V, or in Annex VI where relevant, of
month of the change. The Agency shall make this information
Regulation (EU) No 445/2011;
publicly available.
(b) the period of validity of recognition shall be limited to the
Article 14
validity of the certificate issued by the certification body
Support from the Agency to accreditation or recognition
under which it is granted. In this case, the request of recog
of the assessment body
nition shall be made at the next application for renewal or
update of that certificate.
1. The
Agency
shall
organise
peer
evaluations
between
the
recognition bodies based on the same principles as set out in
Article 10 of Regulation (EC) No 765/2008.
Article 11
Surveillance by recognition body
2. The
Agency
shall
organise,
in
collaboration
with
the
1. By
analogy
to
the
requirements
in
Article
5(3)
and
(4)
of European cooperation for Accreditation (EA), training on this
Regulation (EC) No 765/2008 for accreditation, the recognition
Regulation for the national accreditation bodies and for the
body shall conduct periodic surveillance in order to verify that
recognition bodies at least at each new revision of this Regu
the assessment body it recognised continues to satisfy the
lation.
criteria set out in Annex II during the validity of the recog
nition.
Article 15
Safety assessment reports
2. If the assessment body no longer satisfies the criteria set
out in Annex II, the recognition body shall limit the scope of
1. The
assessment
body
shall
provide
the
proposer
with
a
application of the recognition, suspend or withdraw the recog
safety assessment report in accordance with the requirements
nition, depending on the degree of non-compliance.
set out in Annex III. The proposer shall be responsible for
determining if and how to take into account the conclusions
of the safety assessment report for the safety acceptance of the
Article 12
assessed change. The proposer shall justify and document the
part of the safety assessment report for which the proposer
Relaxed criteria where a significant change is not to be
eventually disagrees.
mutually recognised
Where the risk assessment for a significant change is not to be
2. In the case referred to in point (b) of Article 2(3), in
mutually recognised, the proposer shall appoint an assessment
accordance with paragraph 5 of this Article, the declaration
body meeting at least the competency, independency and
referred to in Article 16 shall be accepted by the national
impartiality requirements of Annex II. The other requirements
safety authority in its decision to authorise the placing in
of paragraph 1 in Annex II may be relaxed in agreement with
service of structural subsystems and vehicles.
the national safety authority in a non-discriminatory way.
3. Without
prejudice
to
Article
16
of
Directive
2008/57/EC,
Article 13
the national safety authority may not request additional checks
or risk analyses unless it is able to demonstrate the existence of
Provision of information to the Agency
a substantial safety risk.
1. Where
applicable,
by
no
later
than
21
May
2015,
Member
States shall inform the Agency which is their national accredi
4. In the case referred to in point (a) of Article 2(3), in
tation body and/or recognition body or recognition bodies for
accordance with paragraph 5 of this Article, the declaration
the purposes of this Regulation, as well as of the assessment
referred to in Article 16 shall be accepted by the notified
bodies they recognised in conformity with Article 9(1)(a). They
body in charge of delivering the conformity certificate, unless
it justifies and documents its doubts concerning the
( 1 ) OJ L 153, 14.6.2007, p. 9.
assumptions made or the appropriateness of the results.

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5. When a system or part of a system has already been
3. The annual maintenance report of entities in charge of
accepted following the risk management process specified in
maintenance of freight wagons referred to in point I(7)(4)(k)
this Regulation, the resulting safety assessment report shall
in Annex III to Regulation (EU) No 445/2011, shall include
not be called into question by any other assessment body in
information about the experience of entities in charge of main
charge of performing a new assessment for the same system.
tenance in applying this Regulation. The Agency shall gather
Mutual recognition shall be conditional upon demonstration
this information in coordination with the respective certification
that the system will be used under the same functional, oper
bodies.
ational and environmental conditions as the already accepted
system, and that equivalent risk acceptance criteria have been
applied.
4. The
other
entities
in
charge
of
maintenance
that
do
not
fall within the scope of Regulation (EU) No 445/2011 shall also
share their experience with the Agency on the application of
Article 16
this Regulation. The Agency shall coordinate the sharing of
experience with these entities in charge of maintenance and
Declaration by the proposer
with the national safety authorities.
Based on the results of the application of this Regulation and
on the safety assessment report provided by the assessment
5. The
Agency
shall
collect
all
information
on
the
experience
body, the proposer shall produce a written declaration that all
of the application of this Regulation and shall, when necessary,
identified hazards and associated risks are controlled to an
make recommendations to the Commission with a view to
acceptable level.
improving this Regulation.
Article 17
6. Before
21
May
2018
the
Agency
shall
submit
to
the
Commission a report containing:
Risk control management and audits
1. The
railway
undertakings
and
infrastructure
managers (a) an analysis of the experience with the application of this
shall include audits of the application of this Regulation in
Regulation, including cases where the CSM has been applied
their recurrent auditing scheme for the safety management
by proposers on a voluntary basis before the relevant date
system as referred to in Article 9 of Directive 2004/49/EC.
of application provided for in Article 20;
2. The entities in charge of maintenance shall include audits
(b) an analysis of the experience of proposers concerning
of the application of this Regulation in their recurrent auditing
decisions on the level of significance of changes;
scheme for the system of maintenance as referred to in
Article 14a(3) of Directive 2004/49/EC.
(c) an analysis of the cases where codes of practice have been
used as set out in point 2.3.8 of Annex I;
3. As part of the tasks defined in Article 16(2)(e) of Directive
2004/49/EC, the national safety authority shall supervise the
(d) an analysis of the experience with the accreditation and
application of this Regulation by railway undertakings, infra
recognition of assessment bodies;
structure managers and the entities in charge of maintenance
that do not fall within the scope of Regulation (EU) No
445/2011 but are identified in its National Vehicle Register.
(e) an analysis of the overall effectiveness of this Regulation.
The national safety authorities shall support the Agency in
4. As
part
of
the
tasks
defined
in
Article
7(1)
of
Regulation collecting such information.
(EU) No 445/2011, the certification body of an entity in charge
of maintenance of freight wagons shall perform surveillance of
the application of this Regulation by the entity in charge of
Article 19
maintenance.
Repeal
Regulation (EC) No 352/2009 is repealed with effect from
Article 18
21 May 2015.
Feedback and technical progress
1. Each
infrastructure
manager
and
each
railway
undertaking References to the repealed Regulation shall be construed as
shall, in its annual safety report referred to in Article 9(4) of
references to this Regulation.
Directive 2004/49/EC, report briefly on its experience with the
application of this Regulation. The report shall also include a
Article 20
synthesis of the decisions on the level of significance of the
changes.
Entry into force and application
This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
2. Each
national
safety
authority
shall,
in
its
annual
safety European Union.
report referred to in Article 18 of Directive 2004/49/EC, report
on the experience of the proposers with the application of this
Regulation, and, where appropriate, its own experience.
It shall apply from 21 May 2015.

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This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 30 April 2013.
For the Commission
The President
José Manuel BARROSO

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ANNEX I
1. GENERAL
PRINCIPLES
APPLICABLE
TO
THE
RISK
MANAGEMENT
PROCESS
1.1. General
principles
and
obligations
1.1.1. The risk management process shall start from a definition of the system under assessment and comprise the
following activities:
(a) the risk assessment process, which shall identify the hazards, the risks, the associated safety measures and the
resulting safety requirements to be fulfilled by the system under assessment;
(b) demonstration of the compliance of the system with the identified safety requirements; and
(c) management of all identified hazards and the associated safety measures.
This risk management process is iterative and is depicted in the diagram of the Appendix. The process ends when
compliance of the system with all the safety requirements necessary to accept the risks linked to the identified
hazards is demonstrated.
1.1.2. The risk management process shall include appropriate quality assurance activities and be carried out by competent
staff. It shall be independently assessed by one or more assessment bodies.
1.1.3. The proposer in charge of the risk management process shall maintain a hazard record in accordance with point 4.
1.1.4. The actors who already have in place methods or tools for risk assessment may continue to apply them if such
methods or tools are compatible with the provisions of this Regulation and subject to the following conditions:
(a) the risk assessment methods or tools are described in a safety management system accepted by a national
safety authority in accordance with Article 10(2)(a) or Article 11(1)(a) of Directive 2004/49/EC; or
(b) the risk assessment methods or tools are required by a TSI or comply with publicly available recognised
standards specified in notified national rules.
1.1.5. Without prejudice to civil liability in accordance with the legal requirements of the Member States, the risk
assessment process shall fall within the responsibility of the proposer. In particular the proposer shall decide,
with agreement of the actors concerned, who will be in charge of fulfilling the safety requirements resulting from
the risk assessment. The safety requirements assigned by the proposer to those actors shall not go beyond the
scope of their responsibility and domain of control. This decision shall depend on the type of safety measures
selected to control the risks to an acceptable level. The demonstration of compliance with the safety requirements
shall be conducted in accordance with point 3.
1.1.6. The first step of the risk management process shall be to identify in a document, to be drawn up by the proposer,
the different actors’ tasks, and their risk management activities. The proposer is responsible for coordinating close
collaboration between the different actors involved, according to their respective tasks, in order to manage the
hazards and their associated safety measures.
1.1.7. Evaluation of the correct application of the risk management process falls within the responsibility of the
assessment body.
1.2. Interfaces
management
1.2.1. For each interface relevant to the system under assessment and without prejudice to specifications of interfaces
defined in relevant TSIs, the rail-sector actors concerned shall cooperate in order to identify and manage jointly the
hazards and related safety measures that need to be handled at these interfaces. The management of shared risks at
the interfaces shall be coordinated by the proposer.
1.2.2. If, in order to fulfil a safety requirement, an actor identifies the need for a safety measure that it cannot implement
itself, it shall, after agreement with another actor, transfer the management of the related hazard to the latter in
accordance with the process set out in point 4.

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1.2.3. For the system under assessment, any actor who discovers that a safety measure is non-compliant or inadequate is
responsible for notifying it to the proposer, who shall in turn inform the actor implementing the safety measure.
1.2.4. The actor implementing the safety measure shall then inform all the actors affected by the problem either within
the system under assessment or, as far as known by the actor, within other existing systems using the same safety
measure.
1.2.5. When agreement cannot be reached between two or more actors it is the responsibility of the proposer to find a
solution.
1.2.6. When a requirement in a notified national rule cannot be fulfilled by an actor, the proposer shall seek advice from
the relevant competent authority.
1.2.7. Independently from the definition of the system under assessment, the proposer is responsible for ensuring that
the risk management covers the system itself and its integration into the railway system as a whole.
2. DESCRIPTION
OF
THE
RISK
ASSESSMENT
PROCESS
2.1. General
description
2.1.1. The risk assessment process is the overall iterative process that comprises:
(a) the system definition;
(b) the risk analysis including the hazard identification;
(c) the risk evaluation.
The risk assessment process shall interact with hazard management in accordance with point 4.1.
2.1.2. The system definition shall address at least the following issues:
(a) system objective (intended purpose);
(b) system functions and elements, where relevant (including human, technical and operational elements);
(c) system boundary including other interacting systems;
(d) physical (interacting systems) and functional (functional input and output) interfaces;
(e) system environment (for example energy and thermal flow, shocks, vibrations, electromagnetic interference,
operational use);
(f) existing safety measures and, after the necessary relevant iterations, definition of the safety requirements
identified by the risk assessment process;
(g) assumptions that determine the limits for the risk assessment.
2.1.3. A hazard identification shall be carried out on the defined system, in accordance with point 2.2.
2.1.4. The risk acceptability of the system under assessment shall be evaluated by using one or more of the following risk
acceptance principles:
(a) the application of codes of practice (point 2.3);
(b) a comparison with similar systems (point 2.4);
(c) an explicit risk estimation (point 2.5).
In accordance with the principle referred to in point 1.1.5, the assessment body shall refrain from imposing the
risk acceptance principle to be used by the proposer.
2.1.5. The proposer shall demonstrate in the risk evaluation that the selected risk acceptance principle is adequately
applied. The proposer shall also check that the selected risk acceptance principles are used consistently.

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2.1.6. The application of these risk acceptance principles shall identify possible safety measures that make the risk(s) of
the system under assessment acceptable. Among these safety measures, those selected to control the risk(s) shall
become the safety requirements to be fulfilled by the system. Compliance with these safety requirements shall be
demonstrated in accordance with point 3.
2.1.7. The iterative risk assessment process is considered to be completed when it is demonstrated that all safety
requirements are fulfilled and no additional reasonably foreseeable hazards have to be considered.
2.2. Hazard
identification
2.2.1. The proposer shall systematically identify, using wide-ranging expertise from a competent team, all reasonably
foreseeable hazards for the whole system under assessment, its functions where appropriate and its interfaces.
All identified hazards shall be registered in the hazard record in accordance with point 4.
2.2.2. To focus the risk assessment efforts upon the most important risks, the hazards shall be classified according to the
estimated risk arising from them. Based on expert judgement, hazards associated with a broadly acceptable risk
need not be analysed further but shall be registered in the hazard record. Their classification shall be justified in
order to allow independent assessment by an assessment body.
2.2.3. As a criterion, risks resulting from hazards may be classified as broadly acceptable when the risk is so small that it
is not reasonable to implement any additional safety measure. The expert judgement shall take into account that
the contribution of all the broadly acceptable risks does not exceed a defined proportion of the overall risk.
2.2.4. During the hazard identification, safety measures may be identified. They shall be registered in the hazard record in
accordance with point 4.
2.2.5. The hazard identification only needs to be carried out at a level of detail necessary to identify where safety
measures are expected to control the risks in accordance with one of the risk acceptance principles referred to
in point 2.1.4. Iteration may be necessary between the risk analysis and the risk evaluation phases until a sufficient
level of detail is reached for the identification of hazards.
2.2.6. Whenever a code of practice or a reference system is used to control the risk, hazard identification may be limited
to:
(a) verification of the relevance of the code of practice or reference system;
(b) identification of the deviations from the code of practice or from the reference system.
2.3. Use of codes of practice and risk evaluation
2.3.1. The proposer, with the support of other involved actors, shall analyse whether one, several or all hazards are
appropriately covered by the application of relevant codes of practice.
2.3.2. The codes of practice shall satisfy at least the following requirements:
(a) They must be widely recognised in the railway domain. If this is not the case, the codes of practice will have to
be justified and be acceptable to the assessment body;
(b) They must be relevant for the control of the considered hazards in the system under assessment. Successful
application of a code of practice for similar cases to manage changes and control effectively the identified
hazards of a system in the sense of this Regulation is sufficient for it to be considered as relevant;
(c) Upon request, they must be available to assessment bodies for them to either assess or, where relevant,
mutually recognise, in accordance with Article 15(5), the suitability of both the application of the risk
management process and of its results.
2.3.3. Where compliance with TSIs is required by Directive 2008/57/EC and the relevant TSI does not impose the risk
management process established by this Regulation, the TSIs may be considered as codes of practice for controlling
hazards, provided requirement (b) of point 2.3.2 is fulfilled.
2.3.4. National rules notified in accordance with Article 8 of Directive 2004/49/EC and Article 17(3) of Directive
2008/57/EC may be considered as codes of practice provided the requirements of point 2.3.2 are fulfilled.

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2.3.5. If one or more hazards are controlled by codes of practice fulfilling the requirements of point 2.3.2, then the risks
associated with these hazards shall be considered acceptable. This means that:
(a) these risks need not be analysed further;
(b) the use of the codes of practice shall be registered in the hazard record as safety requirements for the relevant
hazards.
2.3.6. Where an alternative approach is not fully compliant with a code of practice, the proposer shall demonstrate that
the alternative approach pursued leads to at least the same level of safety.
2.3.7. If the risk for a particular hazard cannot be made acceptable by the application of codes of practice, additional
safety measures shall be identified by applying one of the two other risk acceptance principles.
2.3.8. When all hazards are controlled by codes of practice, the risk management process may be limited to:
(a) hazard identification in accordance with point 2.2.6;
(b) registration of the use of the codes of practice in the hazard record in accordance with point 2.3.5;
(c) documentation of the application of the risk management process in accordance with point 5;
(d) an independent assessment in accordance with Article 6.
2.4. Use
of
reference
system
and
risk
evaluation
2.4.1. The proposer, with the support of other involved actors, shall analyse whether one, several or all hazards are
appropriately covered by a similar system that could be taken as a reference system.
2.4.2. A reference system shall satisfy at least the following requirements:
(a) it has already been proven in-use to have an acceptable safety level and would therefore still qualify for
approval in the Member State where the change is to be introduced;
(b) it has similar functions and interfaces as the system under assessment;
(c) it is used under similar operational conditions as the system under assessment;
(d) it is used under similar environmental conditions as the system under assessment.
2.4.3. If a reference system fulfils the requirements listed in point 2.4.2, then for the system under assessment:
(a) the risks associated with the hazards covered by the reference system shall be considered as acceptable;
(b) the safety requirements for the hazards covered by the reference system may be derived from the safety
analyses or from an evaluation of safety records of the reference system;
(c) these safety requirements shall be registered in the hazard record as safety requirements for the relevant
hazards.
2.4.4. If the system under assessment deviates from the reference system, the risk evaluation shall demonstrate that the
system under assessment reaches at least the same safety level as the reference system, applying another reference
system or one of the two other risk acceptance principles. The risks associated with the hazards covered by the
reference system shall, in that case, be considered as acceptable.
2.4.5. If at least the same safety level as the reference system cannot be demonstrated, additional safety measures shall be
identified for the deviations, applying one of the two other risk acceptance principles.
2.5. Explicit
risk
estimation
and
evaluation
2.5.1. If the hazards are not covered by one of the two risk acceptance principles laid down in points 2.3 and 2.4, the
demonstration of risk acceptability shall be performed by explicit risk estimation and evaluation. Risks resulting
from these hazards shall be estimated either quantitatively or qualitatively, taking existing safety measures into
account.

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2.5.2. The acceptability of the estimated risks shall be evaluated using risk acceptance criteria either derived from or
based on requirements contained in Union legislation or in notified national rules. Depending on the risk
acceptance criteria, the acceptability of the risk may be evaluated either individually for each associated hazard
or the combination of all hazards as a whole considered in the explicit risk estimation.
If the estimated risk is not acceptable, additional safety measures shall be identified and implemented in order to
reduce the risk to an acceptable level.
2.5.3. If the risk associated with one hazard or a combination of several hazards is considered acceptable, the identified
safety measures shall be registered in the hazard record.
2.5.4. If hazards arise from failures of technical systems not covered by codes of practice or the use of a reference system,
the following risk acceptance criterion shall apply for the design of the technical system:
For technical systems where a functional failure has a credible direct potential for a catastrophic consequence, the
associated risk does not have to be reduced further if the rate of that failure is less than or equal to 10 –9 per
operating hour.
2.5.5. Without prejudice to the procedure specified in Article 8 of Directive 2004/49/EC, a more demanding criterion
then the one laid down in point 2.5.4 may be requested, through a notified national safety rule, in order to
maintain a national safety level. In the case of additional authorisations for placing in service of vehicles, the
procedures of Articles 23 and 25 of Directive 2008/57/EC shall apply.
2.5.6. If a technical system is developed by applying the 10 –9 criterion laid down in point 2.5.4, the principle of mutual
recognition is applicable in accordance with Article 15(5).
Nevertheless, if the proposer can demonstrate that the national safety level in the Member State of application can
be maintained with a rate of failure higher than 10 –9 per operating hour, this criterion may be used by the
proposer in that Member State.
2.5.7. The explicit risk estimation and evaluation shall satisfy at least the following requirements:
(a) the methods used for explicit risk estimation shall reflect correctly the system under assessment and its
parameters (including all operational modes);
(b) the results shall be sufficiently accurate to serve as robust decision support. Minor changes in input
assumptions or prerequisites shall not result in significantly different requirements.
3. DEMONSTRATION
OF
COMPLIANCE
WITH
SAFETY
REQUIREMENTS
3.1. Prior to the safety acceptance of the change, fulfilment of the safety requirements resulting from the risk
assessment phase shall be demonstrated under the supervision of the proposer.
3.2. This demonstration shall be carried out by each of the actors responsible for fulfilling the safety requirements, as
decided in accordance with point 1.1.5.
3.3. The approach chosen for demonstrating compliance with the safety requirements as well as the demonstration
itself shall be independently assessed by an assessment body.
3.4. Any inadequacy of safety measures expected to fulfil the safety requirements or any hazards discovered during the
demonstration of compliance with the safety requirements shall lead to reassessment and evaluation of the
associated risks by the proposer in accordance with point 2. The new hazards shall be registered in the hazard
record in accordance with point 4.
4. HAZARD
MANAGEMENT
4.1. Hazard
management
process
4.1.1. Hazard record(s) shall be created or updated (where they already exist) by the proposer during design and
implementation until acceptance of the change or delivery of the safety assessment report. A hazard record
shall track the progress in monitoring risks associated with the identified hazards. Once the system has been
accepted and is in operation, the hazard record shall be further maintained by the infrastructure manager or the
railway undertaking in charge of the operation of the system under assessment as an integrated part of its safety
management system.

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4.1.2. The hazard record shall include all hazards, together with all related safety measures and system assumptions
identified during the risk assessment process. It shall contains a clear reference to the origin of the hazards and to
the selected risk acceptance principles and clearly identify the actor(s) in charge of controlling each hazard.
4.2. Exchange
of
information
All hazards and related safety requirements that cannot be controlled by one actor alone shall be communicated to
another relevant actor in order to find jointly an adequate solution. The hazards registered in the hazard record of
the actor who transfers them shall only be regarded as controlled when the evaluation of the risks associated with
these hazards is made by the other actor and the solution is agreed by all concerned.
5.
EVIDENCE FROM THE APPLICATION OF THE RISK MANAGEMENT PROCESS
5.1. The risk management process used to assess the safety levels and compliance with safety requirements shall be
documented by the proposer in such a way that all the necessary evidence showing the suitability of both the
application of the risk management process and of its results are accessible to an assessment body.
5.2. The documentation produced by the proposer under point 5.1 shall at least include:
(a) a description of the organisation and the experts appointed to carry out the risk assessment process;
(b) results of the different phases of the risk assessment and a list of all the necessary safety requirements to be
fulfilled in order to control the risk to an acceptable level;
(c) evidence of compliance with all the necessary safety requirements;
(d) all assumptions relevant for system integration, operation or maintenance, which were made during system
definition, design and risk assessment.
5.3. The assessment body shall establish its conclusion in a safety assessment report as defined in Annex III.

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Appendix
Risk management process and independent assessment

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ANNEX II
CRITERIA FOR ACCREDITATION OR RECOGNITION OF THE ASSESSMENT BODY
1. The assessment body shall fulfil all requirements of the ISO/IEC 17020:2012 standard and of its subsequent amend
ments. The assessment body shall exercise professional judgement in performing the inspection work defined in that
standard. The assessment body shall fulfil both the general criteria concerning competence and independence in that
standard and the following specific competence criteria:
(a) competence in risk management: knowledge and experience of the standard safety analysis techniques and of the
relevant standards;
(b) all relevant competences for assessing the parts of the railway system affected by the change;
(c) competence in the correct application of safety and quality management systems or in auditing management
systems.
2. By analogy to Article 28 of Directive 2008/57/EC concerning the notification of notified bodies, the assessment body
shall be accredited or recognised for the different areas of competence within the railway system, or parts of it for
which an essential safety requirement exists, including the area of competence involving the operation and main
tenance of the railway system.
3. The assessment body shall be accredited or recognised for assessing the overall consistency of the risk management
and the safe integration of the system under assessment into the railway system as a whole. This shall include
competence of the assessment body in checking the following:
(a) organisation, that is the arrangements necessary to ensure a coordinated approach to achieving system safety
through a uniform understanding and application of risk control measures for subsystems;
(b) methodology, that is evaluation of the methods and resources deployed by various stakeholders to support safety
at subsystem and system level; and
(c) the technical aspects necessary for assessing the relevance and completeness of risk assessments and the level of
safety for the system as a whole.
4. The assessment body may be accredited or recognised for one, several or all of the areas of competence listed in points
2 and 3.

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EN
3.5.2013 Official
Journal
of
the
European
Union L
121/25
ANNEX III
SAFETY ASSESSMENT REPORT OF THE ASSESSMENT BODY
The safety assessment report of the assessment body shall contain at least the following information:
(a) identification of the assessment body;
(b) the independent assessment plan;
(c) the definition of the scope of the independent assessment as well as its limitations;
(d) the results of the independent assessment including in particular:
(i) detailed information on the independent assessment activities for checking the compliance with the provisions of
this Regulation;
(ii) any identified cases of non-compliances with the provisions of this Regulation and the assessment body’s recom
mendations;
(e) the conclusions of the independent assessment.

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Document Outline

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