Proposal for a COUNCIL DIRECTIVE amending Directive 2009/71/EURATOM establishing a Community framework for the nuclear safety of nuclear installations
Date: 2013-10-17
Institutions: European Commission
Subjects: International Atomic Energy Agency, administrative transparency, health risk, ionising radiation, nuclear accident, nuclear power station, occupational safety, radiation protection, radioactive waste, safety standard













EUR-Lex - 52013PC0715 - EN











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52013PC0715

Proposal for a COUNCIL DIRECTIVE amending Directive 2009/71/EURATOM establishing a Community framework for the nuclear safety of nuclear installations /* COM/2013/0715 final - 2013/0340 (NLE) */









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 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, of the European Economic and Social Committee, 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. 
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. 
Finally, in its
Opinion on the draft proposal issued under Article 31 of the Euratom Treaty[23], the European Economic and
Social Committee (EESC) apreciates the prompt action taken by the Commission in
bringing forward the proposal for amending the Nuclear Safety Directive. The
Committee is pleased that several issues highlighted in its previous opinions
on nuclear safety have been adressed in this proposal. In particular, it
welcomes the stronger approach to harmonisation amongst Member States, the clarification
of regulatory responsibilities, competence and capacity, the enhanced independence
of national regulators, and action on on-site emergency preparedness and
response. The Committe also commends the strengthened approach to overall
transparency. Underlining that new legislative requirements should be
necessary, proportionate and serve the purpose of assuring public safety, the
Committee welcomes the appropriate balance that has been achieved in that
perspective in the amending directive.
The Committee
proposed to strenghten the provisions of the draft proposal in some areas and
it recommended that Member States are required to
ensure that a participative processes for strengthening public involvement in
planning, review and decision-making be put in place.
In this regard, the Commission believes that the role of the public in the
regulatory decision-making is recognised through the requirement of the
proposal that it is effectively involved during the licensing process of
nuclear installations.
In accordance
with the procedure laid down in Article 31 of the Euratom Treaty, the
consultation of the European Economic and Social Committee on the draf proposal
was a prerequisite for the subsequent adoption of the final proposal by the
Commission.
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[24], 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[25]
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[26].

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.
2013/0340 (NLE)
Proposal for a
COUNCIL DIRECTIVE
amending Directive 2009/71/EURATOM
establishing a Community framework for the nuclear safety of nuclear
installations
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[27]
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[28] that the Community shares competences, together with its Member
States, in fields covered by the Convention on Nuclear Safety[29].
(5)       Council
Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework
for the nuclear safety of nuclear installations[30]
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[31]
and the Safety Fundamentals[32] 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[33] 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[34]
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[35] 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[36], 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[37].
(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[38] 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[39].
(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[40]
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[41] 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[42]
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[43] 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]             EESC Opinion (TEN/529) of 2 September 2013 on the Draft
Proposal for a Council Directive amending Directive 2009/71/EURATOM
establishing a Community Framework for the nuclear safety of nuclear
installations.
[24]             e.g. Governmental, Legal and Regulatory Framework for
Safety - General safety requirements - IAEA safety standards series no. GSR
part 1
[25]             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) 
[26]             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
[27]               OJ L 159, 29.6.1996, p. 1.
[28]               C-187/87 (1988 ECR p. 5013), C-376/90 (1992 ECR I-6153) and C-29/99 (2002 ECR I‑11221).
[29]               OJ L
172, 6.5.2004, p. 7. 
[30]               OJ L 172, 2.7.2009. p. 18.
[31]               OJ L 318, 11.12.1999, p. 20.
[32]               IAEA Safety Fundamentals: Fundamental safety
principles, IAEA Safety Standard Series No SF-1 (2006).
[33]               OJ L 199, 2.8.2011. p. 48.
[34]               Adopted by the Coreper on 25 April 2007 (doc. Ref.
8784/07) and the Economic and Financial Affairs Council on 8 May 2007.
[35]               OJ L 195, 27.7.2007, p. 44.
[36]             European Council, EUCO 10/1/11. 
[37]             ENSREG Peer review Report –
Stress Tests performed on European nuclear power plants, 25 April 2012.
[38]             COM(2011)
784 final.
[39]             COM (2012) 571 final.
[40]             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.
[41]             Commission proposal for a Decision
of the European Parliament and of the Council on a Union Civil Protection
Mechanism (COM/2011/934 final).
[42]             OJ L 371, 30.12.1987, p. 76.
[43]             OJ L 357, 7.12.1989, p.31.