# EUR-Lex - 52013PC0343 - EN

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# 52013PC0343

**Draft proposal for a COUNCIL DIRECTIVE amending Directive 2009/71/EURATOM establishing a Community framework for the nuclear safety of nuclear installations Draft presented under Article 31 Euratom Treaty for the opinion of the European Economic and Social Committee /* COM/2013/0343 final */**

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EXPLANATORY MEMORANDUM

1.           CONTEXT OF THE PROPOSAL

1.1.        General context

The accident at the Fukushima Daiichi
nuclear power plant (NPP) in 2011 resulted in significant environmental,
economic and social damage, and raised concerns about possible health effects
in the affected population in Japan. Although triggered by an earthquake and
tsunami of an immense magnitude, investigations of the causes of the accident
reveal a range of foreseeable factors which combined to produce a catastrophic
outcome. The analysis of the Fukushima nuclear accident reveals quite
substantial and recurring technical issues as well as persistent institutional
failures similar to the ones from the post-accident evaluations of the Three
Mile Island and Chernobyl nuclear accidents decades ago. This latest nuclear
accident once again undermined public confidence in the safety of nuclear
power; and particularly so at a time when the use of nuclear power is being
debated as a possible option to meet global energy demands in a sustainable
manner.

The Fukushima nuclear accident renewed
attention on the paramount importance of ensuring the most robust levels of
nuclear safety in the EU and worldwide.

Nuclear energy currently generates close to
30% of all electricity in the EU and about two-thirds of its low-carbon
electricity. The EU has 132 operating reactors, representing about one-third of
the 437 operating nuclear power reactors in the world. Many of the EU NPPs were
constructed already three to four decades ago, and are based on designs and
safety provisions that were continuously updated since then.

Nuclear safety is of the utmost importance
to the EU and its people. The effects of nuclear accidents do not stop at
national borders and can entail potential harmful consequences for the health
of workers and citizens but also wide-ranging economic implications. It is
therefore essential for society and the economy to reduce the risk of a nuclear
accident in an EU Member State by applying high nuclear safety standards and
guaranteeing a high quality of regulatory oversight.

In the aftermath of the Fukushima nuclear
accident, the EU response to the events was immediate.

Based upon a mandate from the European
Council at its meeting of 24-25 March 2011[1],
the European Commission, together with the European Nuclear Safety Regulators
Group (ENSREG), launched EU-wide comprehensive risk & safety assessments of
nuclear power plants ('Stress Tests'). The Stress Tests were defined as a
targeted reassessment of the safety margins of NPPs in the light of the events
in Fukushima related to extreme natural events challenging the plants safety
functions. All fourteen EU Member States that operate nuclear power plants[2] plus Lithuania[3] participated in these
assessments. Switzerland, Ukraine and Croatia participated fully in the EU
Stress Tests and the peer review process, while other neighbouring countries
(e.g. Turkey, Belarus and Armenia) that agreed to use the same methodology, are
working within different timetables. Stress Tests were started in 2011 by self-assessments
carried out by nuclear operators and the preparation of national reports by
national regulators. Preliminary findings were presented in a Commission Communication on an Interim Stress Tests Report[4] in
November 2011 and an extensive EU-wide peer review process was carried out from
January to April 2012. An overview report was produced by the ENSREG Peer
Review Board[5] and endorsed by ENSREG. In addition, ENSREG also agreed on
an Action Plan[6] to follow up the implementation of the peer review recommendations.
In October 2012, the Commission issued a Communication on the Final Stress
Tests Report[7]. Currently, in line with the requirements of the ENSREG
Action Plan, National Action Plans[8] associated with post-Fukushima lessons learned and
Stress Test peer review recommendations have been prepared and were reviewed in
terms of contents and status of implementation in the framework of a Workshop
in April 2013. The Summary Report of the Workshop is intended to be presented
at the 2013 Second ENSREG Conference on Nuclear Safety in Europe[9]. Furthermore in the process of
ensuring a proper follow-up of the Stress Tests, the Commission will elaborate,
in close cooperation with ENSREG, a consolidated report on the status of the
implementation of the Stress Tests recommendations, envisaged to be issued in
June 2014 and transmitted to the European Council.

In the legislative domain, the European
Commission received a clear mandate from the European Council in March 2011
"to review the existing legal and regulatory framework for the safety of
nuclear installations" and propose any improvements that may be necessary.

The European Parliament has also encouraged
a legislative review. In the 2011 Resolution on energy infrastructure
priorities for 2020 and beyond[10],
it stated that "future legislative initiatives to set up a common
framework for nuclear safety are essential in order to continuously improve
safety standards in Europe". Furthermore, in the 2011 Resolution on the
Commission Work Programme 2012[11],
the Parliament called for "an urgent revision of the Nuclear Safety
Directive with a view to its strengthening, namely by taking into account the
results of the Stress Tests implemented in the aftermath of the Fukushima
accident". More recently, in the 2013 Resolution on Stress Tests[12], it called on the revision to
be "ambitious in nature", including major improvements in areas such
as "safety procedures and frameworks – in particular through the
definition and implementation of binding nuclear safety standards that reflect
state-of-the-art practices in the EU in technical, regulatory and operational
respects – as well as in the role and resources of the nuclear regulatory
authorities and, in particular, should boost the latter's independence,
openness and transparency, while also strengthening monitoring and peer
review".

The European Economic and Social Committee
expressed in the 2012 Opinion on the Commission
Communication on a Final Stress Tests Report[13] its
support for the "Commission's intention to undertake an ambitious revision
of the Nuclear Safety Directive".

In response to the mandate from the
European Council and the calls from the other EU institutions and bodies, the
Commission engaged in a comprehensive process of analysis and opinion
gathering, to identify the appropriate areas and mechanisms for legislative
intervention. This process included an open on-line public consultation
(December 2011 – February 2012), complemented by an extensive dialogue with the
stakeholders.

The 2011 and
2012 Stress Tests Communications contain indications on the potential areas of
legislative improvement. In this context, with reference to the existing
Council Directive 2009/71/Euratom establishing a Community framework for the
nuclear safety of nuclear installations[14]
(hereinafter referred to as "Nuclear Safety Directive"), the latter
Communication highlights the areas of safety procedures and frameworks, role
and means of nuclear regulatory authorities, openness and transparency,
monitoring and verification.

Moreover, the Commission services developed
in the course of 2012 an Impact Assessment, based on a wide range of
information sources and taking into account the post-Fukushima EU and
international developments in the nuclear domain.

On this basis, a draft proposal for a Directive
amending the Nuclear Safety Directive has been developed, benefiting from the
input and expertise of the Euratom Treaty Article 31 Group of scientific
experts, as well as an extensive consultation process with the high-level
representatives of the national nuclear regulatory authorities reunited in
ENSREG.

1.2.        Grounds and objectives of
the proposal

The current
Nuclear Safety Directive has been a key advancement. However, in the spirit of
nuclear safety's philosophy of continuous improvement, and thus with the
intention to take account inter alia of the lessons learned from the
Fukushima nuclear accident and of the outcomes of the subsequent Stress Tests,
it was necessary to reconsider the sufficiency of the existing provisions.

The Fukushima nuclear accident has shown
that well-known lessons learned from accidents decades ago have not been taken
up voluntarily by parts of the industry and not been sufficiently enforced by
regulators, even in a nation – Japan – that was assumed to have particularly high
standards of industrial and nuclear safety. The technical and organisational
issues arising from the analysis of this accident are therefore relevant for
wider consideration.

In Europe, the Stress Tests have confirmed
that there are continued differences between Member States in ensuring
comprehensive and transparent identification and management of key safety
issues. Moreover, the Stress Tests clearly showed the benefits of cooperation
and coordination mechanisms between all parties having responsibilities for
nuclear safety, such as peer reviews.

In addition, in the course of the public
meetings held in the framework of the Stress Tests, demands have emerged to
extend the assessment to emergency preparedness and response arrangements.

The Commission considers it therefore
appropriate to amend, strengthen and supplement the Nuclear Safety Directive,
by combining technical improvements with wider safety issues such as
governance, transparency and on-site emergency preparedness and response.

The proposed amendments aim at enhancing
the regulatory framework for nuclear safety in the EU, in particular by:

–
Strengthening the role and effective
independence of the national regulatory authorities;

–
Enhancing transparency on nuclear safety
matters;

–
Strengthening existing principles, and
introducing new general nuclear safety objectives and requirements, addressing
specific technical issues across the entire lifecycle of nuclear installations,
particularly NPPs;

–
Reinforcing monitoring and exchange of
experiences, by establishing a European system of peer reviews;

–
Establishing a mechanism for developing EU-wide
harmonised nuclear safety guidelines.

1.3.        Existing EU legislation in
the nuclear safety area

Following the
recognition by the Court of Justice of the EU in the Case 29/99[15] of the intrinsic link between
radiation protection and nuclear safety and, thus, of the competence of the
Euratom Community to legislate in the area of nuclear safety, the Nuclear
Safety Directive is the first EU-wide topical legally binding instrument[16]. The Directive sets up a
legally binding framework based upon recognised principles and obligations of
the main international instruments available, namely the Convention on Nuclear
Safety[17]
and the Safety Fundamentals[18]
established by the International Atomic Energy Agency (IAEA).

1.4.        Consistency with other
policy areas

The Euratom nuclear safety legislation, due
to the fact that it ultimately aims at ensuring the protection of the workers
and the general public against the dangers of ionising radiation, is mainly
linked to the Euratom radiation protection corpus of legislation, whose
main pillar is the Basic Safety Standards Directive[19]. It is not possible to achieve
the protection of workers and the general public from the dangers of ionising
radiation without controlling the potentially harmful sources of that
radiation.

Nuclear safety is also of paramount
importance for the overall prevention, preparedness for and response to
disasters in the Member States. The nuclear safety directive is thus closely
linked to the Union Civil Protection Mechanism[20]
which provides the framework for the EU cooperation in this area, including the
response to radiological emergencies inside and outside the Union.

2.           RESULTS OF CONSULTATIONS WITH THE
INTERESTED PARTIES AND IMPACT ASSESSMENTS

2.1.        Consultation of interested
parties

In the period following the Fukushima
nuclear accident, the Commission has engaged in an extensive and transparent
dialogue process with the various stakeholders and the public, which included
launching an open consultation via the Internet, in line with the Commission's
minimum consultation standards[21].

In response to the on-line public
consultation seeking views on areas of reinforcing the existing
Euratom nuclear safety legislative framework, contributions
were received from nuclear regulatory
authorities, other public authorities, companies, non-governmental
organisations, as well as individuals. This consultation offers insights into a
large range of stakeholder opinions. The broad outcome shows that more
than 90% of respondents agree on the importance of a Euratom nuclear safety
framework, setting up common rules for EU Member States, whilst 76% agree with
the need to reinforce the existing safety legislative framework.

The Commission
also received both written and meeting-based contributions from various
stakeholders, e.g. nuclear regulatory authorities, other public authorities,
individual companies, industry associations and non-governmental organisations.
In addition, the Commission has organised with ENSREG conferences and public
debates involving a wide range of stakeholders, including non-governmental
organisations, on the process, the intermediate and final results of the Stress
Tests[22].

The European
social partners from the Electricity Sectoral Social Dialogue Committee
industry have also been consulted. In their response, the social partners
underline the role of a Euratom nuclear safety legislative framework in setting
up common rules for Member States.

A special role
was given to ENSREG, which represents a unique focal point of expertise, as it
reunites high-level representatives of the national competent nuclear
regulatory authorities from all the EU Member States, nuclear and non-nuclear
alike. A detailed contribution of ENSREG was received and taken into account.

Finally, as
part of the procedure laid out in the Euratom Treaty, the Commission consulted
the Article 31 Group of scientific experts. In their opinion, the experts
welcomed the Commission proposal for amending the Nuclear Safety Directive and
make several suggestions for enhancing the link with radiation protection
legislation.

2.2.        Impact Assessment

In 2012, an Impact Assessment was
developed. The document analyses the challenges of ensuring sufficient levels
of nuclear safety in the EU. It defines the general and specific objectives for
enhancing the prevention and mitigation of nuclear accidents. A number of
policy options are proposed and analysed, ranging from maintaining the current
situation to more profound reforms. Each option has been assessed for its
estimated safety, economic, environmental and social impacts.

3.           LEGAL ELEMENTS OF THE PROPOSAL

3.1.        Legal Basis

Any legislative
amendment should build upon and enhance the approach of the current Nuclear
Safety Directive. The legal basis remains thus Articles 31 and 32 of the
Euratom Treaty.

3.2.        Subsidiarity and
proportionality

The proposal
aims at strengthening even further the role and independence of the competent
regulatory authorities, as it is clear that only strong regulators endowed with
all the necessary powers and independence guarantees can oversee and ensure the
safe operation of nuclear installations in the EU. Close cooperation and
information-sharing between regulators, taking into account the potential
cross-border impacts of a nuclear accident, is encouraged.

Given the wide
consequences of a nuclear accident and particularly the public need for
information in such a case, an EU-wide approach on transparency issues is
essential. This can ensure that, irrespective of state borders, the public is
properly informed on all relevant nuclear safety matters. The existing
provisions of the Directive are amended in this sense.

In Europe, the
Stress Tests have confirmed that there are not only continued differences
between the EU Member States in ensuring comprehensive and transparent
identification and management of key safety issues, but that also gaps remain.
Therefore, the Nuclear Safety Directive is strengthened to include a set of
shared objectives aiming at harmonising the EU approach to nuclear safety.
Moreover, the experience from the Fukushima nuclear accident and the valuable
insights coming from the Stress Tests have clearly shown that exchange of
information and peer-reviews are an essential element to ensure the effective
and continuous implementation of any safety regime.

In accordance with the proportionality principle, the proposed legislative action does not
go beyond what is necessary to achieve the objectives. Furthermore, taking into
account the different situations in the Member States, a flexible and
proportionate approach as regards the level of applicability is defined. A mechanism of joint development by the Member States of EU-wide
technical guidelines is defined with special regard to the principle of
proportionality, by using the knowledge and practical experience of the
regulatory experts.

The applicability and the extent of the
provisions of the proposal vary according to the type of nuclear installation.
Therefore, when implementing these provisions, Member States should follow a
proportionate approach, taking account of the risks from the specific types of
nuclear installations.

3.3.        Legal elements of the
proposal

The proposal introduces new or strengthens
the existing provisions of the Nuclear Safety Directive with the overall aim of
continuously improving nuclear safety and its regulation at EU level. Specific
information on the main proposed amendments of the Nuclear Safety Directive is
presented below.

Objectives

Article 1 is complemented with a new
objective aiming at ensuring the avoidance of radioactive releases during all
stages of the lifecycle of nuclear installations (siting, design, construction,
commissioning, operation, decommissioning).

Definitions

In Article 3,
new definitions are introduced corresponding to terms used in the new
provisions, such as "accident", "abnormal event",
"design basis", "design basis accident", "beyond
design basis accident", "periodic safety review". These
definitions are aligned with the international terminology, such as the IAEA
Safety Glossary.

Legislative,
regulatory and organisational framework

Article 4 is
amended in order to further clarify the main elements of the national
framework. For instance, it is specified that the national safety requirements
mentioned in Article 4(1)(a) should cover all stages of the lifecycle of
nuclear installations.

Competent regulatory authority
(effective independence, regulatory role)

The Nuclear Safety
Directive contains only minimal provisions underlying
the independence of the national competent regulatory authority in Article 5(2). These provisions are strengthened in line
with latest international guidance[23], by defining strong and effective benchmark
criteria and requirements to guarantee the effective independence of
regulators. New requirements include ensuring effective independence in
decision-making, own appropriate budget allocations and autonomy in
implementation, clear requirements for the appointment and dismissal of staff,
avoidance and resolution of conflicts of interests, and staffing levels with
the necessary qualifications, experience and expertise.

The Nuclear
Safety Directive enumerates in a general manner the main competencies of the
competent regulatory authority in Article 5(2). Through the amendment, these provisions are further detailed to
ensure that regulators possess the appropriate powers to
carry out a strong regulatory oversight. For this purpose, the core task of the
competent regulatory authority to define national nuclear safety requirements
is added to the existing catalogue of regulatory competencies.

Transparency

The existing provisions of Article 8 of the
Nuclear Safety Directive are limited to generic requirements on public
information. Moreover, this Article does not impose any obligation on the
licence holder, who has the prime responsibility for nuclear safety. To fill these gaps, in the proposed amendment, the existing provisions are extended and specified. Thus, both the
competent regulatory authority and the licence holder are required to develop a
transparency strategy, which covers information provision under normal
operating conditions of nuclear installations as well as communication in case
of accident or abnormal event conditions. The role of the public is fully
acknowledged through the requirement that it effectively participates in the
licensing process of nuclear installations. Recently organised exchanges with
experts[24]
in the field have confirmed that the public has a very important role to play
by being involved effectively in the decision-making procedures and that their
views should be considered, taking into account the provisions of the Aarhus
Convention[25].

Nuclear Safety Objectives

The current
Nuclear Safety Directive does not include specific requirements for the
different stages of the lifecycle of nuclear installations. Therefore, for
example the type of risks related to the issues identified in the analysis of
the Fukushima accident and the subsequent Stress Tests are not sufficiently
identified and addressed by the provisions of the current Directive, e.g.:

·
The need to evaluate the appropriateness of the
siting of nuclear installations based on considerations on how to prevent,
where possible, and minimise the impact from external hazards;

·
The need to continuously re-assess the
probability of such hazards and their impacts in the course of periodic safety
reviews and perform a corresponding design basis review for each nuclear
installation, including for the purpose of possible lifetime extension;

·
The need to base risk assessments, including
those for external events, on methods reflecting progress in scientific
development and thus enable effective continuous improvement of safety.

In line with
the principle of continuous improvement of nuclear safety the amendment
introduces general safety objectives for nuclear installations (Article 8a)
which reflect the progress achieved at the level of WENRA in developing safety
objectives for new NPPs.

For achieving these high level safety
objectives, more detailed provisions are laid down for different life-cycle
phases of nuclear installations (Article 8b).

In addition, in order to support their
consistent implementation, methodological requirements concerning the siting,
design, construction, commissioning, operation and decommissioning of nuclear
installations, are laid out in Article 8c.

This approach
provides flexibility to the national frameworks, by assigning high level
objectives that have to be fulfilled by national legislation in line with the
principle of continuous improvement of nuclear safety. For example, this leaves
to Member States the choice of selecting among the available engineering
solutions to upgrade their nuclear installations when addressing safety issues
based on lessons learned from severe accidents, such as the need to allow safe
depressurizing of a reactor containment in case of an accident (e.g. by means
of containment filtered venting).

On-site emergency preparedness and
response

The amendment includes provisions regarding
on-site emergency preparedness and response as the current Directive does not
provide for such measures. The new provisions include indications on the
planning and organisational measures that should be provided by the licence
holder (Article 8d). As an example of new requirements, the amendment
prescribes that an on-site emergency response centre is required for a nuclear
installation, sufficiently protected against the effects from external events
and severe accidents, including radiological ones, and equipped with the
necessary material to mitigate the effects of severe accidents.

Peer Reviews

The existing provisions of the Nuclear
Safety Directive of Article 9(3) include a requirement for periodic
self-assessment of the Member States national framework and competent
regulators authorities, combined with the obligation to invite an international
peer review on relevant segments. This concept remains unchanged in the
proposal, in Article 8e(1).

The amendment introduces new provisions on
self-assessments and peer-reviews of nuclear installations based on nuclear
safety topics selected by the Member States jointly and
in close coordination with the Commission across the
entire lifecycle of nuclear installations (example could be the above-mentioned
containment depressurisation in case of severe accident in order to avoid
hydrogen explosion). Should Member States fail to
jointly select at least a topic, the European Commission should select the
topics to be subject to the peer reviews. Further, each
  Member State has to define a methodology for the implementation of the
technical recommendations from the peer review process. Should the Commission identify substantial deviations or delays in
the implementation of the technical recommendations from the peer review
process, the Commission should invite the competent regulatory authorities of
Member States not concerned to organise and carry out a verification mission to
get a full picture of the situation and inform the Member State concerned about
possible measures to remedy any identified shortcomings.

In case of an accident with off-site
consequences, a special peer review should be arranged.

This new compulsory and regular mechanism
of EU peer reviews (Article 8e(2) to (5)) aims at verifying the level of technical
compliance with the safety objectives in each Member State.

These
new provisions setting out the peer-review mechanism are without prejudice to the
rules governing the infringement procedure in case a Member State fails to fulfil an obligation under the Treaties, as laid out in Articles 258, 259 and
260 of the Treaty on the Functioning of the European Union (TFEU).

Proportionate implementation of the
amended Directive

The amendment
acknowledges that the applicability and the extent of the provisions of the
amended Directive vary according to the type of nuclear installation.
Therefore, when implementing these provisions, Member States should follow a
proportionate approach, taking account of the risks posed by the specific types
of nuclear installations they plan or operate.

Reporting on practical implementation of
the amended directive

The provisions of the Nuclear Safety
Directive on reporting are not changed by this proposal, leaving the date for
the first reporting on 22 July 2014 at which the Member States are expected to
submit a report on the implementation of the existing provisions of the
Directive. At the time of the second reporting on the implementation however,
by 22 July 2017, the Member States should report on the implementation of the
Nuclear Safety Directive as amended by this proposal.

4.           BUDGETARY IMPLICATION

The proposal has no
budgetary implications for the EU budget.

5.           EXPLANATORY DOCUMENTS

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

With regard to this Directive, the
Commission considers the transmission of such documents to be justified for the
following reasons:

·
The complexity of the transposition of the
amended Nuclear Safety Directive at national level

The existing provisions of the Nuclear
Safety Directive are significantly strengthened by this proposal which also
introduces new substantial provisions in several areas. The complexity of
transposition of the amended directive is therefore determined by the fact that
is covers many different issues, including requirements on national framework
for nuclear safety of nuclear installations, role and independence of national
regulatory authorities, obligations of the licence holders, skills in nuclear
safety, transparency on nuclear safety matters, technical objectives and
requirements on nuclear safety of nuclear installations, on-site emergency
preparedness and response and provisions on national assessments of nuclear
installations and related topical peer-reviews. Moreover, the directive places
requirements on different Member States' bodies as well as private actors.

The different obligations inherent to the amended
directive are therefore likely to lead to a complex transposition at national
level. The existing provisions of the Nuclear Safety Directive have already
been transposed in general by several national transposition measures per Member State, the number is however exceeding 15 transposition measures in some cases. The
number of notified transposition measures can be legitimately expected to rise
with the new provisions brought to the existing directive by this proposal.
Furthermore, due to the specificity of nuclear safety, various transposition
measures are used and notified to the Commission, ranging from laws, government
decrees and ministerial orders to instructions and decisions of national
nuclear regulatory authorities.

The need for explanatory documents
explaining the relationship between the provisions of the amended Nuclear
Safety Directive and the corresponding parts of national transposition measures
seems to be obvious under these circumstances.

·
Pre-existing national legislation

In some Member States, some legislation is
already in place in the area of amendments brought by this proposal. The
transposition of the amended Directive is therefore likely to result in a
combination of amendments to existing national legislation and adoption of new
legislation. In such a situation, the explanatory documents would be necessary
to obtain a clear and comprehensive picture of the transposition.

·
Framework directive

The proposed amendments do not
fundamentally change the 'framework' character of the Nuclear Safety Directive.
The amended directive continues to include general principles and requirements.

It is important for the Commission and its
monitoring of transposition and implementation to know which national
provisions transpose the general principles and requirements that the amended
directive lays down. For instance, the proposal introduces general safety
objectives and requirements for all types of nuclear installations. Given the
very broad scope of these new safety objectives and requirements, it is of
utmost importance for the Commission but also the public to be able to
ascertain how they are transposed at national level.

PROPORTIONALITY PRINCIPLE

The requirement to provide explanatory
documents can create an additional administrative burden on the Member States.
This burden is however not disproportionate considering
the objectives of the amended Nuclear Safety Directive and the complexity of
its subject matter. It is furthermore necessary for the Commission to allow effective verification of correct transposition. There are no less burdensome measures to allow
efficient verification, considering the likely complexity of transposition at
national level which may result in new or amended legislation. It is also to be
mentioned that a relevant number of Member States have already been notifying
useful explanatory documents to the Commission on their transposition of the
existing Euratom legislation such as the existing Nuclear Safety Directive or
other pieces of legislation.

Draft
proposal for a
COUNCIL DIRECTIVE

amending
Directive 2009/71/EURATOM establishing a Community framework for the nuclear
safety of nuclear installations
Draft presented under Article 31 Euratom Treaty for the opinion of the European
Economic and Social Committee

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the
European Atomic Energy Community, and in particular Article 31 and 32 thereof,

Having regard to the proposal from the
European Commission, drawn up after obtaining the opinion of a group of persons
appointed by the Scientific and Technical Committee from among scientific
experts in the Member States,

Having regard to the opinion of the
European Parliament,

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

Whereas:

(1)
Article 2(b) of the Treaty establishing the
European Atomic Energy Community ('Euratom Treaty') provides for the establishment
of uniform safety standards to protect the health of workers and of the general
public.

(2)
Article 30 of the Euratom Treaty provides for
the establishment of basic standards within the European Atomic Energy
Community ('Community') for the protection of the health of workers and the
general public against the dangers arising from ionizing radiations.

(3)
Council Directive 96/29/Euratom of 13 May 1996
laying down basic safety standards for the protection of the health of workers
and the general public against the dangers arising from ionizing radiation[26] establishes the basic safety standards. This
Directive establishes requirements for a system of radiation protection
including the justification and optimisation of radiation exposures and
dose-limitation for public and occupational exposure. It specifies requirements
for the control of radiation exposures to the public and to workers under both
normal operations and emergency situations. The
provisions of Directive 96/29/Euratom have been supplemented by more specific
legislation.

(4)
The Court of Justice of the European Union has
recognised in its case-law[27] that
the Community shares competences, together with its Member States, in fields
covered by the Convention on Nuclear Safety[28].

(5)
Council Directive 2009/71/Euratom of 25 June
2009 establishing a Community framework for the nuclear safety of nuclear
installations[29] imposes obligations on the Member States to establish and maintain
a national framework for nuclear safety. That Directive reflects the provisions
of the main international instruments in the field, namely the Convention on
Nuclear Safety[30]
and the Safety Fundamentals[31] established by the International Atomic
Energy Agency ('IAEA'). The deadline for Member States to bring into force and
notify the Commission the laws, regulations and administrative procedures to
comply with, Directive 2009/71/Euratom expired on 22 July 2011.

(6)
Council Directive 2011/70/Euratom of 19 July
2011 establishing a Community framework for the responsible and safe management
of spent fuel and radioactive waste[32]
imposes obligations on the Member States to establish and maintain a national
framework for spent fuel and radioactive waste management.

(7)
Council Conclusions of 8 May 2007 on nuclear
safety and safe management of spent nuclear fuel and radioactive waste[33] highlighted that “nuclear
safety is a national responsibility exercised where appropriate in an
EU-framework. Decisions concerning safety actions and the supervision of nuclear
installations remain solely with the operators and national authorities”.

(8)
Following up on the Council’s invitation to set
up a High Level Group at EU level, as recorded in its above mentioned
Conclusions of 8 May 2007, the European Nuclear Safety Regulators Group
(ENSREG) was established by Commission Decision 2007/530/Euratom of 17 July
2007 on establishing the European High Level Group on Nuclear Safety and Waste
Management[34] to contribute to the achievement of the Community objectives in the
field of nuclear safety.

(9)
The Fukushima nuclear accident in Japan in 2011 renewed attention worldwide on the measures needed to minimise risk and
ensure the most robust levels of nuclear safety. Based on a mandate from the European Council in March 2011[35], the Commission, together with the European Nuclear Safety
Regulator Group ('ENSREG'), carried out Union wide comprehensive risk and
safety assessments of nuclear power plants ('stress tests'). The results
identified a number of improvements which could be implemented in nuclear
safety approaches and industry practices in the participating countries[36].

(10)
Moreover, the European Council also mandated the
Commission to review the existing legal and regulatory framework for the
safety of nuclear installations and propose any improvements that may be
necessary. The European Council also stressed that the highest standards for
nuclear safety should be implemented and continuously improved in the EU.

(11)
The Commission included initial views on
potential areas of legislative improvement in its Communication on the Interim
Report on the Comprehensive Risk and Safety Assessments ("stress tests") of
Nuclear Power Plants in the European Union[37] of 24 November 2011.

(12)
In line with its general principles of
consultation and dialogue, the Commission also conducted an on-line public
consultation, between December 2011 and February 2012, seeking views on areas
of reinforcing the Community nuclear safety framework.

(13)
The Commission identified a number of areas for
revising the current Directive 2009/71/Euratom, as outlined in its 4 October
2012 Communication from the Commission to the Council and the European
Parliament on the comprehensive risk and safety assessments
("stress-tests") of nuclear power plants in the EU and related
activities[38].

(14)
In identifying the relevant areas for
improvement, the Commission took into account technical progress achieved at
European and international level, the experience and results gained from the
stress tests, the findings of the various reports into the Fukushima nuclear
accident, the views expressed in the public consultation on areas of
reinforcing the Community legislative framework, the views expressed by
different stakeholders including national competent regulatory authorities,
industry and civil society, and the results of the preliminary assessment of
the transposing measures of the Member States.

(15)
A strong and independent competent regulatory
authority is a fundamental condition of the European nuclear safety regulatory
framework. Its independence and the exercise of its powers impartially and
transparently are crucial factors to ensure a high level of nuclear safety.
Objective regulatory decisions and enforcement actions should be established
without any undue external influence that might compromise safety, such as
pressures associated with changing political, economic or societal conditions,
or pressures from government departments or any other public or private
entities. The negative consequences of the lack of independence were evident in
the Fukushima accident. The provisions of Directive 2009/71/Euratom on
functional separation of competent regulatory authorities should be
strengthened to ensure the regulatory authorities' effective independence and
to guarantee that they are provided with the appropriate means and competencies
to properly carry out the responsibilities assigned to them. In particular, the
regulatory authority should have sufficient legal powers, sufficient staffing
and sufficient financial resources for the proper discharge of its assigned
responsibilities. The strengthened requirements aiming at ensuring independence
in carrying out the regulatory tasks should be however without prejudice to
close cooperation, as appropriate, with other relevant national authorities or
to general policy guidelines issued by the government not related to the
regulatory powers and duties.

(16)
The independence of the regulatory authority's
decision making further depends on the competence of its staff. Therefore the
regulatory authority should employ staff with the necessary qualifications,
experience and expertise to be able to undertake its functions and
responsibilities. Given the specialised nature of the nuclear industry and the
limited availability of persons with the required expertise and competence,
resulting in the possible rotation of persons with executive responsibility
between the nuclear industry and the regulators, special attention should be
given to avoiding conflicts of interest. Moreover, arrangements should be made
to ensure that there is no conflict of interest for those organisations that
provide the regulatory body with advice or services.

(17)
When undertaking infrastructure projects that
could affect the nuclear safety of nuclear installations, the appropriate
national mechanisms of consultation with national regulatory authorities and
the public should be in place and full account should be taken of the opinions
expressed by them.

(18)
Directive 2011/92/EU on the assessment of the
effects of certain public and private projects on the environment[39] is relevant for nuclear
installations. This Directive provides that the Member States must ensure that,
before development consent is given, projects likely to have significant
effects on the environment by virtue, inter alia, of their nature, size
or location are made subject to an assessment of the environmental effects. In
this regard, it is a tool for ensuring that environmental considerations are
integrated in the licensing process of nuclear installations.

(19)
Any assessment under
this Directive is without prejudice to any relevant environmental assessment.

(20)
For nuclear installations for which the
obligation to carry out assessments of the effects on the environment arises
simultaneously from this Directive and other Union legislation, Member States
may provide for coordinated or joint procedures fulfilling the requirements of
the relevant Union legislation.

(21)
The consequences of a nuclear accident can go
beyond national borders, therefore close cooperation, coordination and
information exchange between regulatory authorities of neighbouring countries
or of countries in the same region, irrespective of whether they operate
nuclear installations or not, need to be encouraged. In this respect, Member
States should ensure that appropriate arrangements are in place to facilitate
such cooperation on nuclear safety matters with cross-border impacts, including
with third countries. Synergies should be sought with the
Union Civil Protection Mechanism[40]
which provides an EU framework for cooperation between the Member States in the
field of civil protection in improving the effectiveness of systems for
preventing, preparing for and responding to natural and man-made disasters.

(22)
In order to ensure that the proper skills are
acquired and that adequate levels of competence are achieved and maintained,
all parties should ensure that all staff (including sub-contractors), having
responsibilities relating to the nuclear safety of nuclear installations and to
the on-site emergency preparedness and response arrangements, undergo a continuous
learning process. This can be achieved through the establishment of training
programmes and training plans, procedures for periodic review and updating of
the training programmes as well as appropriate budgetary provisions for
training.

(23)
Another key lesson learned from the Fukushima nuclear accident is the importance of enhancing transparency on nuclear safety
matters. Transparency is also an important means to promote independence in
regulatory decision making. Therefore, the current provisions of Directive
2009/71/Euratom on the information to be provided to the public should be more
specific as to which type of information should be provided, as a minimum by
the competent regulatory authority and by the licence holder, and within which
time frames. To this purpose, for example, the type of information that should
be provided, as a minimum by the competent regulatory authority and by the
licence holder as part of their wider transparency strategies, should be
identified. Information should be released in a timely manner, particularly in
case of abnormal events and accidents. Results of periodic safety reviews and
international peer reviews should also be made public.

(24)
The requirements of this Directive on
transparency are complementary to those of the existing Euratom legislation.
Council Decision 87/600/Euratom of 14 December 1987 on Community arrangements
for the early exchange of information in the event of a radiological emergency[41] imposes obligations on Member States to notify and provide
information to the Commission and to other Member States in case of a
radiological emergency on its territory, whilst Council Directive 89/618
Euratom of 27 November 1989[42] includes requirements on Member States to inform the public about
health protection measures to be applied and steps to be taken in the event of
a radiological emergency, and to provide advance and continuing information to
the population likely to be affected in the event of a such an emergency.
However, in addition to the information to be provided in such an event, Member
States should under this Directive arrange for appropriate transparency
provisions, with prompt and regularly updated release of information to ensure
that workers and the general public are kept informed about all nuclear safety
related events, including abnormal events or accident conditions. Moreover, the
public should be given opportunities to participate effectively in the
licencing process of nuclear installations and the competent regulatory
authority should provide any safety-related information independently, without
need for prior consent from any other public or private entity.

(25)
The Directive 2009/71/Euratom sets up a
legally binding Community framework underlying a nuclear safety legislative,
administrative and organisational system. It does not include specific
requirements for nuclear installations. In view of the technical progress
achieved by the IAEA, and the Western European Nuclear Regulators Association
('WENRA') and other sources of expertise, including the lessons learned from
the stress tests and the Fukushima nuclear accident investigations, Directive
2009/71/Euratom should be amended to include Community nuclear safety
objectives covering all stages of the lifecycle of nuclear installations
(siting, design, construction, commissioning, operation, decommissioning).

(26)
Risk-informed methods examine the probability of
each event in an event sequence likely to lead or contribute to an accident as
well as its possible consequences. The answers can be used to provide insights
into the strengths and weaknesses of the design and operation of a nuclear
installation and can thus guide requirements and regulatory attention to the
issues where the largest benefit for the safety of a nuclear installation can
be obtained. Having invested over the last decades considerable resources in
developing Probabilistic Safety Assessments for nuclear installations,
particularly for nuclear power plants and research reactors, licence holders
and competent regulatory authorities worldwide are now in a position to use the
insights derived to enhance the safety of nuclear installations on a
risk-informed basis while operating them in the most efficient manner.

(27)
Ageing of the safety related structures, systems
and components of a nuclear installation, and especially embrittlement of
components which are difficult to replace in practice, such as reactor pressure
vessels, puts a natural limit to its acceptable continued operation. From both
a safety and an economical point of view, the limit of operational lifetime is
typically 40 years after the start of commercial operation therefore Member
States should ensure that possible lifetime extension of existing nuclear power
plants does not expose the workers and the public to additional risks. To this
end, Directive 2009/71/Euratom should be amended to include new Community wide
safety objectives to be complied with by the regulatory authorities and the
licence holders in case of a lifetime extension of existing nuclear power
plants.

(28)
For new reactor design, there is a clear
expectation to address in the original design what was beyond design for
previous generations of reactors. Design extension
conditions are accident conditions that are not considered for design basis
accidents, but are considered in the design process of the installation in
accordance with best estimate methodology, and for which releases of
radioactive material are kept within acceptable limits. Design extension
conditions could include severe accident conditions.

(29)
Application of the concept of defence-in-depth
in organisational, behavioural, or design activities related to a nuclear
installation, ensures that safety related activities are subject to independent
layers of provisions, such that if a failure were to occur, it would be detected
and compensated by appropriate measures. The independent effectiveness of each
of the different layers is an essential element of defence in depth to prevent
accidents and mitigate the consequences if they do occur.

(30)
After the nuclear accidents at Three Mile Island
and Chernobyl, the Fukushima nuclear accident highlighted once again the
critical importance of the containment function, which is the last barrier to
protect people and the environment against radioactive releases resulting from
an accident. Therefore the applicant for a licence for the construction of a
new power or research reactor should demonstrate that the design practically
limits the effects of a reactor core damage to within the containment, i.e. he
has to prove that a radioactive release outside the containment is physically
impossible or can be considered extremely unlikely with a high degree of
confidence for such release to occur.

(31)
Directive 2009/71/Euratom does not include measures regarding on-site emergency preparedness
and response, which, as the Fukushima nuclear accident highlighted, are crucial
to mitigate the consequences of a nuclear accident.
Council Directive 96/29/Euratom foresees that, in case of radiological
emergencies, it is necessary to organise appropriate intervention to stop or
reduce the emission of radionuclides, and to assess and record the consequences
of the emergency and the effectiveness of the intervention. Measures should
also be in place for the protection and monitoring of the environment and
population. However, more specific provisions regarding on-site emergency
preparedness and response are needed in order to assess situations that might
require on-site protective measures, to have an organisational structure and
coordination among response bodies, and to ensure that sufficient resources are
available to apply those appropriate protective measures even in extreme cases.

(32)
The stress tests demonstrated the key role of
enhanced cooperation and coordination mechanisms between all parties having
responsibilities for nuclear safety. The peer-reviews have proved to be a good
means of building confidence, with the aim of developing and exchanging
experience and ensuring the common application of high nuclear safety
standards. The scope of the provisions of Directive 2009/71/Euratom is however
limited only to self-assessments and international peer-reviews of Member
States' legislative, regulatory and organisational infrastructure and therefore
the Directive should be widened to include peer reviews of nuclear installations.

(33)
This Directive introduces new provisions on
self-assessments and peer-reviews of nuclear installations based on selected
nuclear safety topics covering their entire lifecycle. At an international
level, there is already confirmed experience with conducting such peer-reviews
on nuclear power plants. At the EU level, the experience from the stress tests
process shows the value of a coordinated exercise to assess and review the
safety of EU nuclear power plants. A similar mechanism, based on cooperation
between the Member States' regulatory authorities and the Commission, should be
applied here. Therefore, competent regulatory authorities coordinating in the
context of expert groups such as ENSREG, could contribute with their expertise
to identifying the relevant safety topics and in carrying out these peer
reviews. If Member States fail to jointly select at
least one topic the Commission should select one or more topics to be subject
to the peer reviews. Participation
of other stakeholders, such as Technical Support Organisations, international
observers or non-governmental Organisations could bring added value to the peer
reviews.

(34)
In order to guarantee the rigour and the
objectivity of the peer reviews, Member States should provide access to all necessary
information, subject to the required security clearance procedures, to staff
and to the nuclear installation concerned.

(35)
An appropriate follow-up mechanism should be
established to ensure that the outcome of these peer-reviews is properly
implemented. Peer reviews should help improve the safety of individual nuclear
installations as well as help formulate generic technical safety
recommendations and guidelines valid across the Union.

(36)
In case the Commission
identifies substantial deviations
or delays in the implementation of the technical recommendations from the peer
review process, the Commission should invite the competent regulatory
authorities of Member States not concerned to organise and carry out a
verification mission with the aim of getting a full picture of the situation
and informing the Member State concerned about possible measures to remedy any
identified shortcomings.

(37)
The provisions setting out the peer-review
mechanism of this Directive are without prejudice to the rules governing the
procedure in case a Member State fails to fulfil an obligation under the
Treaties, as laid out in Articles 258, 259 and 260 of the Treaty on the
Functioning of the European Union (TFEU).

(38)
The periodicity of the peer reviews and the
reporting under this Directive should be aligned with the review and reporting
cycles of the Convention on Nuclear Safety.

(39)
In line with the principle of proportionality,
the applicability of the provisions of Chapter 2, Section 2 "Specific
Obligations" of this Directive depends on the type of nuclear
installations on the territory of a Member State. Therefore, when implementing
these provisions in national law, Member States should take account of the
risks posed by the specific types of nuclear installations they plan or operate.
In particular, the proportionality principle will concern those Member States
that keep only a small inventory of nuclear and radioactive materials, e.g.
linked to the operation of smaller research reactor facilities, which in case
of a severe accident would not engender consequences comparable to those
generated by nuclear power plants.

(40)
The provisions of this Directive which are
intrinsically linked to the existence of nuclear installations, namely those
concerning the licence holder's obligations, the new specific requirements for
nuclear installations and the provisions concerning the on-site emergency
preparedness and response are not applicable to Member States without nuclear
installations as defined by this Directive. These Member States need not transpose
and implement the requirement to impose penalties on those who do not comply
with this Directive. The other provisions of this Directive should be
transposed and implemented in a proportionate manner in accordance with
national circumstances and taking into account the fact that these Member
States do not have nuclear installations, whilst ensuring that nuclear safety
receives appropriate attention by the government or by the competent
authorities.

(41)
According to Directive 2009/71/Euratom, the
Member States have to establish and maintain a national legislative, regulatory
and organisational framework ('national framework') for nuclear safety of
nuclear installations. The determination on how the provisions of the national
framework are adopted and through which instrument they are applied rests with
the competence of the Member States.

(42)
In accordance with the Joint Political
Declaration of Member States and the Commission on explanatory documents of 28
September 2011, Member States have undertaken to accompany, in justified cases,
the notification of their transposition measures with one or more documents
explaining the relationship between the provisions of a directive and the
corresponding parts of national transposition instruments. With regard to this
Directive, the legislator considers the transmission of such documents to be
justified.

(43)
Directive 2009/71/Euratom should therefore be
amended accordingly,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 2009/71/Euratom is amended as
follows:

(1)
The heading of Chapter 1 is replaced by the
following:

"OBJECTIVES, SCOPE OF APPLICATION AND
DEFINITIONS".

(2)
In Article 1, the following point (c) is added:

"(c) to ensure that Member States shall
provide for appropriate national arrangements so that nuclear installations are
designed, sited, constructed, commissioned, operated or decommissioned so as to
avoid unauthorised radioactive releases."

(3)
Article 2 is amended as follows:

(a)
paragraph 1 is replaced by the following:

"1. This Directive shall apply to any
civilian nuclear installation subject to a licence as defined in Article 3(4)
at all stages covered by this licence.";

(b)
paragraph 3 is replaced by the following:

"3. This Directive supplements the basic
standards referred to in Article 30 of the Treaty as regards the nuclear safety
of nuclear installations and is without prejudice to the existing Community
legislation for the protection of the health of the workers and the general
public against the dangers arising from ionising radiation, and in particular Directive
96/29/Euratom.".

(4)
In Article 3, the following paragraphs 6 to 17
are added:

"6.          ‘defence-in-depth’ means a hierarchical deployment of different levels of
diverse equipment and procedures to prevent the escalation of anticipated
operational occurrences and to maintain the effectiveness of physical barriers
placed between a radiation source or radioactive material and workers, members
of the public or the air, the water and the soil, in operational states and,
for some barriers, in accident conditions;

7.       ‘abnormal event’ means any unintended occurrence the consequences,
or potential consequences of which are not negligible from the point of view of
protection or nuclear safety;

8.       'accident' means any unplanned event,
including operating errors, equipment failures and other mishaps, the
consequences or potential consequences of which are not negligible from the
point of view of protection or nuclear safety;

9.       'early releases' means situations that
would require off-site emergency measures but with insufficient time to
implement them;

10.     'large releases' means situations that
would require protective measures for the public that could not be limited in
area or time;

11.     'practically eliminating' means that it
is physically impossible or it can be considered extremely unlikely with a high
degree of confidence for a condition to occur;

12.     'reasonably achievable' means that, in
addition to meeting the requirements of good practice in engineering, further
safety or risk reduction measures for the design,
commissioning, operation or decommissioning of a
nuclear installation should be sought and that these measures should be
implemented unless it can be demonstrated that they are grossly
disproportionate with regard to the safety benefit they would confer;

13.     'design basis' means the range of
conditions and events taken explicitly into account in the design of an
installation, according to established criteria, so that the installation can
withstand them without exceeding authorised limits by the planned operation of safety
systems;

14.     'design basis accident' means accident
conditions against which an installation is designed according to established
criteria, and for which the damage to the fuel and the release of radioactive
material are kept within authorised limits;

15.     'beyond design basis accident' means an
accident which is possible, but was not fully considered in the design because
it was judged to be too unlikely;

16.     'design
extension analysis' means a set of design extension
conditions derived on the basis of engineering judgement, deterministic
assessments and probabilistic assessments for the purpose of further improving
the safety of the nuclear power plant by enhancing the plant’s capabilities to
withstand, without unacceptable radiological consequences, accidents that are
either more severe than design basis accidents or that involve additional
failures. These design extension conditions are used to identify the additional
accident scenarios to be addressed in the design and to plan practicable
provisions for the prevention of such accidents or the mitigation of their
consequences if they do occur.

17.     'periodic safety review' means a
systematic reassessment of the safety of an existing installation carried out
at regular intervals to deal with the cumulative effects of ageing,
modifications, operating experience, technical developments and siting aspects
and aimed at ensuring a high level of safety throughout the service life of the
installation.".

(5)
In Chapter 2, the following title is inserted
after the heading ‘OBLIGATIONS’:

"SECTION
1

General
obligations".

(6)
Article 4, paragraph 1 is amended as follows:

(a)
the introductory part is replaced by the
following:

"1. Member States shall establish and
maintain a national legislative, regulatory and organisational framework
(hereinafter referred to as the ‘national framework’) for nuclear safety of
nuclear installations that allocates responsibilities and provides for
coordination between relevant state bodies. The national framework shall
provide in particular for:";

(b)
point (a) is replaced by the following:

"(a)       national nuclear safety
arrangements, covering all stages of the lifecycle of nuclear installations
referred to in Article 3(4);";

(c)
point (b) is replaced by the following:

"(b)       a system of licensing and prohibition of operation of
nuclear installations without a licence;";

(d)
point (c) is replaced by the following:

"(c)       a system of nuclear safety supervision;".

(7)
In Article 5, paragraphs 2 and 3 are replaced by
the following:

"2.      Member States shall guarantee the effective independence of the
competent regulatory authority from undue influence in its decision making, in
particular when carrying out the regulatory tasks set out in paragraph 3, ensuring that safety is not
subordinated to political, economic or societal interests. For this purpose,
Member States shall ensure that the national framework requires that the
competent regulatory authority:

(a) is functionally separate from any other
public or private entity concerned with the promotion or utilisation of nuclear
energy or electricity production;

(b) does not seek or take instructions from any
other public or private entity concerned with the promotion or utilisation of
nuclear energy or electricity production, when carrying out its regulatory
tasks;

(c) takes regulatory decisions, founded on
objective and verifiable safety-related criteria;

(d) has its own appropriate budget allocations,
with autonomy in the implementation of the allocated budget. The financing
mechanism and the budget allocation process shall be clearly defined in the
national framework;

(e) employs an appropriate number of staff with
the necessary qualifications, experience and expertise;

(f) establishes procedures and criteria for the
appointment and dismissal of staff, and for the prevention and resolution of
any conflicts of interest;

(g) provides safety-related information without
review or clearance from any other public or private entity in accordance with
Article 8(2).

3.       Member States shall ensure that the
competent regulatory authority is given the legal powers necessary to fulfil
its obligations in connection with the national framework described in Article
4(1) with due priority to safety. For this purpose, Member States shall
ensure that the national framework provides for the following main regulatory
tasks:

(a)      to define national nuclear safety
requirements;

(b)     to require the licence holder to comply
with national nuclear safety requirements and the terms of the relevant
licence;

(c)      to require demonstration of this
compliance, including the requirements under paragraphs 2 to 5 of Article
6 and Articles 8a to 8d;

(d)     to verify this compliance through
regulatory assessments and inspections;

(e)      to carry out enforcement actions,
including suspending the operation of a nuclear installation in accordance with
the conditions defined by the national framework referred to in Article
4(1).".

(8)
Article 6 is amended as follows:

(a) paragraph 1 is replaced by the following:

"1.      Member
States shall ensure that the national framework requires that the prime
responsibility for the nuclear safety of a nuclear installation rests with the
licence holder. This responsibility cannot be delegated.";

(b) paragraph 2 is replaced by the following:

"2. Member States
shall ensure that the national framework requires licence holders, under the
supervision of the competent regulatory authority, to regularly assess and
verify, and continuously improve, as far as reasonably achievable, the nuclear
safety of their nuclear installations in a systematic and verifiable
manner.";

(c) paragraph 3 is replaced by the following:

"3.      The
assessments referred to in paragraph 2 shall include verification that, based
on a comprehensive safety assessment, measures are in place for the prevention
of accidents and mitigation of the consequences of accidents, including
verification of the sufficiency of defence-in-depth provisions and the licence
holders' organisational measures of protection that would have to fail before
workers and the general public would be significantly affected by ionising
radiations.";

(d) paragraph 4 is replaced by the following:

"4.      Member States
shall ensure that the national framework requires licence holders to establish
and implement management systems which give due priority to nuclear safety and
are regularly verified by the competent regulatory authority.";

(e) the following paragraph 4a is inserted:

"4a.    Member
States shall ensure that the national framework requires that when applying for
a licence, the applicant is required to submit a detailed demonstration of
safety. Its scope and level of detail shall be commensurate with the potential
magnitude and nature of the hazard presented. It shall be reviewed and assessed
by the competent regulatory authority in accordance with clearly defined
procedures.";

(f) paragraph 5 is replaced by the following:

"5.      Member States shall ensure that
the national framework requires licence holders to provide for and maintain adequate
financial and human resources, with appropriate qualifications, expertise and
skills, to fulfil their obligations with respect to nuclear safety of a nuclear
installation, laid down in paragraphs 1 to 4a of this Article and Articles 8a
to 8d of this Directive. These obligations also extend to subcontracted
workers.".

(9)
Articles 7 and 8 are replaced by the following:

"Article 7

Expertise
and skills in nuclear safety

Member States shall ensure that the national
framework requires all parties to make arrangements for education,
training and exercise for their staff having responsibilities relating to the
nuclear safety of nuclear installations and to on-site emergency preparedness
and response arrangements, in order to build up, maintain and to further
develop up-to-date and mutually recognised expertise and skills in nuclear
safety.

Article
8

Transparency

1. Member States shall ensure that up to date
and timely information in relation to nuclear safety of nuclear installations and related risks is made available to
workers and the general public, with specific consideration to those living in
the vicinity of a nuclear installation.

The obligation established in the first
subparagraph includes ensuring that the competent regulatory authority and the
licence holders, within their fields of responsibility, develop, publish and
implement a transparency strategy covering, inter alia, information on normal
operating conditions of nuclear installations, non-mandatory consultation
activities with the workers and the general public and communication in case of
abnormal events and accidents.

2. Information shall be made available to the
public in accordance with applicable Union and national legislation and
international obligations, provided that this does not jeopardise other
overriding interests, such as security, recognised in national legislation or
international obligations.

3. Member States shall ensure that the public shall be given early and effective opportunities to participate in
the licensing process of nuclear installations, in accordance with relevant Union and national legislation and
international obligations.".

(10)
The following Section 2 is inserted after
Article 8:

"SECTION 2

Specific
obligations

Article
8a

Safety
objective for nuclear installations

1. Member States shall ensure that the national
framework requires that nuclear installations are designed, sited, constructed,
commissioned, operated and decommissioned with the objective of avoiding
potential radioactive releases by:

(a)
practically eliminating the occurrence of all
accident sequences which would lead to early or large releases;

(b)
for accidents that have not been practically
eliminated, implementing design measures so that only limited protective
measures in area and time are needed for the public and that sufficient time is
available to implement these measures, and that the frequency of such accidents
is minimised.

2. Member States shall ensure that the national
framework requires that the objective set out in paragraph 1 applies to
existing nuclear installations to the extent reasonably achievable.

Article
8b

Implementation
of the safety objective for nuclear installations

In order to achieve the safety objective set
out in Article 8a, Member States shall ensure that the national framework
requires that nuclear installations are:

(a)        sited so
that due consideration is provided to avoid, where
possible, external natural and man-made hazards and
minimise their impact;

(b)        designed, constructed, commissioned,
operated and decommissioned based on the defence-in-depth concept so that:

(i) radiation doses to workers and the general
public do not exceed prescribed limits and are kept as low as reasonably
achievable;

(ii) the occurrence of abnormal events is
minimised;

(iii) the potential for escalation to accident
situations is reduced by enhancing the nuclear installations’ capability to effectively manage and control
abnormal events;

(iv) harmful consequences of abnormal events
and design basis accidents, should they occur, are mitigated to ensure that
they induce no off-site radiological impact, or only minor radiological impact;

(v) external natural and man-made hazards are
avoided, where possible, and their impact is minimised.

Article
8c

Methodology
for siting, design, construction, commissioning, operation and decommissioning
of nuclear installations

1. Member States shall
ensure that the national framework requires that the licence holder, under the
supervision of the competent regulatory authority:

(a)
regularly evaluates the radiological impact of a
nuclear installation on workers, the general public and air, water and soil, in
both normal operating and in both operating and accident conditions;

(b)
defines, documents and re-assesses regularly and
at least every ten years, the design basis of nuclear installations through a
periodic safety review, and supplements it by a design extension analysis, to
ensure that all reasonably practicable improvement measures are implemented;

(c)
ensures that the design extension analysis
covers all accidents, events and combination of events, including internal and
external natural or man-made hazards and severe accidents, leading to
conditions not included in the design basis accidents;

(d)
establishes and implements strategies to
mitigate both design basis and beyond-design basis accidents;

(e)
implements Severe Accident Management Guidelines for all nuclear power plants and, if appropriate, other nuclear
installations, covering all operational conditions,
accidents in the spent fuel pools and long-duration events;

(f)
carries out a specific safety review for nuclear
installations which the competent regulatory authority
considers to be close to the limit
of their operating lifetime as originally foreseen, and
for which an extension
of the lifetime is requested.

2. Member States shall
ensure that the national framework requires that the granting or the review of
a licence to construct and/or operate a nuclear installation should be based
upon an appropriate site- and installation-specific safety assessment.

3. Member States shall ensure that the national
framework requires, for nuclear power plants and, if applicable, for research
reactor facilities, for which a construction licence is sought for the first
time, that the competent
regulatory authority obliges the applicant to demonstrate that the design
practically limits the effects of a reactor core damage to within the containment.

Article
8d

On-site
emergency preparedness and response

Member States shall ensure that the national
framework requires that the licence holder, under the supervision of the
competent regulatory authority:

(a)
prepares and regularly updates an on-site emergency
plan which shall:

(i) be based on an assessment of events and
situations that may require protective measures on-site or off-site;

(ii) be co-ordinated with all other bodies involved and shall draw
on lessons learned from the feedback of experience from
severe events, should they occur;

(iii) address in particular events that could impact multiple units of a nuclear
installation;

(b)
establishes the necessary organisational
structure for clear allocation of responsibilities and ensures the availability
of necessary resources and assets;

(c)
puts in place arrangements for co-ordinating
on-site activities and co-operating with authorities and agencies responsible
for emergency response throughout all phases of an emergency, that should be
regularly exercised;

(d)
provides for preparedness measures for the
workers on-site with regard to potential abnormal events and accidents;

(e)
provides arrangements for cross-border and
international cooperation, including pre-defined arrangements for receiving
on-site external assistance, if needed;

(f)
arranges for an on-site emergency response
centre, sufficiently protected against natural hazards and radioactivity to
ensure its habitability;

(g)
takes protective measures in case of an
emergency in order to mitigate any
consequences for human health and for air, water and soil.".

(11)
The following Chapter 2a is inserted after Chapter 2:

"CHAPTER 2a

PEER
REVIEWS AND GUIDELINES

Article
8e

Peer
Reviews

1. Member States shall at least every ten years
arrange for periodic self-assessments of their national framework and competent
regulatory authorities and invite an international peer review of relevant
segments of their national framework and competent regulatory authorities with
the aim of continuously improving nuclear safety. Outcomes of any peer review
shall be reported to the Member States and the Commission, when available.

2.
Member States, with the support of the competent
regulatory authorities, shall periodically arrange, and at least
every six years, a system of topical peer reviews and agree on a time-frame and
the modalities for implementation. For this purpose Member
States shall:

(a)
jointly and in close coordination with the
Commission select one or more specific topics related to the nuclear safety of
nuclear installations. Should Member States fail to jointly select at least a
topic within the time frame specified in this paragraph, the Commission shall select the topics to be the subject of the peer reviews;

(b)
based on these topics,
perform in close collaboration with licence holders, national assessments and publish the results;

(c)
jointly define a methodology, arrange and carry
out a peer review of the results
of the national assessments referred to in point (b), to which the
Commission is invited to participate;

(d)
publish the results of the peer reviews referred to in point (c).

3.
Each Member State subject to the peer review referred to in paragraph 2 shall arrange for the planning and mode of
implementation on its territory of relevant technical recommendations resulting
from the peer-review process and shall inform the
Commission thereof.

4. Should the Commission identify substantial
deviations or delays in the implementation of the technical recommendations resulting from the peer review process, the
Commission shall invite the competent regulatory authorities of Member States
not concerned to organise and carry out a verification mission to get a full
picture of the situation and inform the Member State concerned about possible
measures to remedy any identified shortcomings.

5. In case of an accident which leads to an
early or large release or an abnormal event leading to situations that would
require off-site emergency measures or protecting measures for the public, the
Member State concerned shall invite within six months a peer review of the
installation concerned in accordance with paragraph 2, and to which the Commission shall be invited to
participate.

Article
8f
Guidelines for the improvement of nuclear safety

Based
on the results of the peer reviews performed in accordance
with Article 8e(2) and the resulting technical
recommendations, in line with the principles of transparency and continuous
improvement of nuclear safety, Member States shall, with the support of the
competent regulatory authorities, jointly develop and establish guidelines on
the specific topics referred to in
Article 8e(2)(a).".

(12)
The following title is inserted after Chapter
2a:

"CHAPTER 2b

GENERAL
PROVISIONS".

(13)
In Article 9, paragraph 3 is deleted.

(14)
The following Article 9a is inserted after
Article 9:

"Article
9a
Penalties

The Member States shall lay down the rules on
penalties applicable to infringements of the national provisions adopted
pursuant to this Directive and shall take all measures necessary to ensure that
they are implemented. The penalties provided for must be effective,
proportionate and dissuasive. The Member States shall notify those provisions
to the Commission by [insert date –this date must
correspond to the deadline for transposition set out in article 2 of this
proposal] at the latest and shall notify it without
delay of any subsequent amendment affecting them.".

(15)
In Article 10, the following paragraph 1a is
inserted after paragraph 1:

"1a. The obligations of transposition and implementation of Articles
6, 8a, 8b, 8c, 8d and 9a of this Directive shall not apply to Cyprus, Ireland,
Luxembourg and Malta, unless they decide
to develop any activity related to nuclear installations subject to a licence
under their jurisdiction.".

Article 2

1.           Member States shall bring
into force the laws, regulations and administrative provisions necessary to
comply with this Directive by [deadline for transposition to be inserted in
the course of the legislative process] at the latest. They shall forthwith
communicate to the Commission the text of those provisions.

When Member States adopt those provisions, they
shall contain a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member States shall
determine how such reference is to be made.

2.           Member States shall communicate
to the Commission the text of the main provisions of national law which they
adopt in the field covered by this Directive and of any subsequent amendments to those
provisions.

Article 3

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

Article 4

This Directive is addressed to the
Member States.

Done at Brussels,

For
the Council

The
President

[1]               European Council Conclusions EUCO 10/1/11

[2]               Belgium, Bulgaria, Czech
Republic, Finland, France, Germany, Hungary, Netherlands, Romania, Slovak
Republic, Slovenia, Spain, Sweden, United Kingdom

[3]               The Ignalina NPP is being
decommissioned

[4]               COM 784 final

[5]               Peer review Report – Stress
Tests performed on European nuclear power plants www.ensreg.eu

[6]               ENSREG Action Plan regarding the follow-up of the
peer-review of the stress tests performed on European nuclear power plants

[7]               COM (2012) 571, 04.10.2012

[8]               17 National Action Plans are available on the ENSREG
website www.ensreg.eu

[9]               http://www.ensreg.eu/ensreg-conferences

[10]             P7_TA(2011)0318

[11]             P7_TA(2011)0327

[12]             P7_TA(2013)0089

[13]             TEN/498

[14]       OJ L 172, 2.7.2009

[15]             Judgment of the Court of Justice of 10 December 2002
[2002] ECR I-11221

[16]             Only two legally non-binding Council Resolutions of
22 July 1975 and 18 June 1992 on the technological problems
of nuclear safety existed beforehand

[17]             INFCIRC/449 of 5
July 1994

[18]             IAEA Safety Standard Series no SF-1 (2006)

[19]             Council Directive 96/29/Euratom laying down basic
safety standards for the protection of the health of workers and the general
public against the dangers arising from ionising radiation

[20]             Commission proposal for a Decision
of the European Parliament and of the Council on a Union Civil Protection
Mechanism (COM/2011/934 final), intending inter alia
to replace Council Decision 2007/779 of 8 November 2007
establishing a Community Civil Protection Mechanism (recast).

[21]             COM(2002)
704 final

[22]             For instance, the first ENSREG Conference on 28-29 June
2011, a Stakeholders Conference on Peer Reviews on 17 January 2012, a Public
Debate on Stress Tests and Peer Review Results on 8 May 2012. The second ENSREG
Conference is scheduled for June 2013.

[23]             e.g. Governmental, Legal and Regulatory Framework for
Safety - General safety requirements - IAEA safety standards series no. GSR
part 1

[24]             Series of international workshops between 2009-2013
with the participation of DG ENER, DG ENV from the Commission side and National
Association of Committees and Commission of Information - French “Local
Commissions of Information” (CLIs) and their national federation (ANCCLI)

[25]             Convention on access to information, public
participation in decision-making and access to justice in environmental
matters, ratified on 17 February 2005 by Council Decision 2005/370/EC

[26]               OJ L 159, 29.6.1996, p. 1.

[27]               C-187/87 (1988 ECR p. 5013), C-376/90 (1992 ECR I-6153) and C-29/99 (2002 ECR I‑11221).

[28]               OJ L
172, 6.5.2004, p. 7.

[29]               OJ L 172, 2.7.2009. p. 18.

[30]               OJ L 318, 11.12.1999, p. 20.

[31]               IAEA Safety Fundamentals: Fundamental safety
principles, IAEA Safety Standard Series No SF-1 (2006).

[32]               OJ L 199, 2.8.2011. p. 48.

[33]               Adopted by the Coreper on 25 April 2007 (doc. Ref.
8784/07) and the Economic and Financial Affairs Council on 8 May 2007.

[34]               OJ L 195, 27.7.2007, p. 44.

[35]             European Council, EUCO 10/1/11.

[36]             ENSREG Peer review Report –
Stress Tests performed on European nuclear power plants, 25 April 2012.

[37]             COM(2011)
784 final.

[38]             COM (2012) 571 final.

[39]             OJ L 26, 28.01.2012, p.1 - codified version of
Directive 85/337/EEC on the assessment of the effects of certain public and
private projects on the environment, as amended.

[40]             Commission proposal for a Decision
of the European Parliament and of the Council on a Union Civil Protection
Mechanism (COM/2011/934 final).

[41]             OJ L 371, 30.12.1987, p. 76.

[42]             OJ L 357, 7.12.1989, p.31.