Explanatory Memorandum to COM(2008)790 - Community framework for nuclear safety

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dossier COM(2008)790 - Community framework for nuclear safety.
source COM(2008)790 EN
date 26-11-2008
1. CONTEXT OF THE PROPOSAL

2.

1.1. Grounds for and objectives of the proposal


The present draft Directive setting up a Community framework on Nuclear Safety aims at re-starting the process of establishing a common EU framework on nuclear safety, by updating and replacing the Commission proposal for a Council (Euratom) Directive setting out basic obligations and general principles on the safety of nuclear installations i, included in the initial Nuclear Safety Package.

The renewed interest in nuclear power expressed by a number of Member States, with the perspective of numerous life extensions and construction of new plants, makes the timing of this revised proposal particularly appropriate. It is evident that the effects of radiological incidents do not stop at borders, with potential consequences both for the health of workers and citizens, but also wide ranging economic implications for the energy generating industry. Enacting in binding Community legislation internationally endorsed nuclear safety principles would ensure an additional level of guarantee for the public in the EU at large, by providing legal certainty.

In this framework, the revised legislative proposal builds on: a) the technical work of the Western European Nuclear Regulators Association (WENRA) completed in 2006 for existing nuclear installations, with the participation of all European nuclear safety regulators; b) the principle that only strong and independent regulators can ensure the continued safe operation of the nuclear power plants in the EU; c) enshrining in the Community legislation the principles of the main international instruments available, namely the Convention on Nuclear Safety (CNS) i, concluded under the auspices of the International Atomic Energy Agency (IAEA), and the safety work carried out by the IAEA i.

Its basic approach is that a set of common principles in the field of nuclear safety, already included in the CNS, are regulated at Community level, supplemented with additional safety requirements for new nuclear power reactors, which Member States are encouraged to develop in line with the principle of continuous improvement of safety, on the basis of the safety levels developed by WENRA and in close collaboration with the European High Level Group on Nuclear Safety and Waste Management (HLG). Based on the ten principles for the regulation of nuclear safety adopted by it, the group will become the focal point for cooperation between the regulatory bodies charged with the safety of nuclear installations in the Member States and will contribute to the development of the EU nuclear safety framework.

The general objective of the proposal is to achieve, maintain and continuously improve nuclear safety in the Community and to enhance the role of the regulatory bodies. Its scope of application is the design, siting, construction, maintenance, operation and decommissioning of nuclear installations, for which consideration of safety is required under the legislative and regulatory framework of the Member State concerned. The right of each Member State to decide to use nuclear energy or not is recognised and fully respected.

By means of this Community nuclear safety framework, several operational objectives are envisaged to be achieved, namely enhancing the role of national regulators, prime responsibility of the licence holder for safety under the control of the regulatory body, reinforcing the independence of the regulatory body, ensuring a high level of transparency on issues related to the safety of nuclear installations, implementation of management systems, regular safety supervision, availability of nuclear safety expertise, priority to safety.

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1.2. General context


At present, the interest in nuclear energy is undergoing a revival phase, due to a number of driving factors.

The EU is the largest nuclear electricity generator in the world, having a mature nuclear industry, spanning the entire fuel cycle with its own technological base and highly skilled workforce. Nuclear energy is currently the main low-carbon source in many EU Member States, providing more than a third of the EU electricity, and it has proven to be a stable, reliable source, relatively shielded from price fluctuations when compared to the oil and gas markets. Continued use of nuclear energy therefore would contribute to the EU energy supply security as well as to the limitation of CO2 emissions, but it is also still confronted with a number of outstanding issues that need to be resolved. Nuclear energy plays an important role in the EU energy mix, supported by a firm commitment in research and promotion of technological developments, aimed at further enhancing its safety and security.

The continuous improvement of the safety of nuclear installations is a prerequisite for the acceptance of nuclear energy. Building on the existing work carried out under the auspices of the IAEA and bringing it within the Community framework would add value to the national approaches. Interlinking the national systems and the Community system will guarantee the maintenance of a high level of safety for nuclear installations in the EU and will enhance the transparency of the EU regulatory mechanisms. In a long-term perspective, this shall result in an improved public confidence in the EU decision-making process on nuclear safety matters and bring legal certainty.

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1.3. Existing Community instruments advocating for nuclear safety harmonization at EU level


With the development of the European nuclear industry, convergence at Community level became necessary in order to support the Member States in their efforts to harmonise safety practices. The Council Resolution of 22 July 1975 on the technological problems of nuclear safety i recognised that it was the Commission's responsibility to act as a catalyst in initiatives taken at international level in the field of nuclear safety. This Resolution, while 'taking into account the prerogatives and responsibilities assumed by national authorities' , makes reference to the alignment of safety requirements in the context of a desirable harmonised approach at Community level.

Against this background, a second Council Resolution was adopted in 1992 i, in which the Council reaffirmed the intentions of the 1975 Resolution and invited Member States to continue and intensify concerted efforts towards harmonization of safety issues.

In addition, the support for the elaboration of Community nuclear safety legislation has been constantly reflected over the years in the Council Conclusions i and in the European Parliament Reports i. However, binding Community legislation in the area of nuclear safety has not been adopted until present.

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1.4. Consistency of the proposal with other policies and objectives of the Union


The intrinsic link between radiation protection and nuclear safety was recognised by the European Court of Justice in its ruling in the Case C-29/99, according to which “ it is not appropriate, in order to define the Community’s competencies, to draw an artificial distinction between the protection of the health of the general public and the safety of sources of ionising radiation". The Court has also confirmed that the Commission has competence to make recommendations for harmonising the measures required by Articles 18 and 19 of the CNS concerning the design, construction and operation of nuclear installations which can be the subject of the provisions which the Member States lay down to ensure compliance with the basic standards. The development of a Community approach in the field of nuclear safety would contribute to the full achievement of the objectives of the community acquis in the area of radiation protection, namely protecting the workers and the general public against the dangers of ionising radiation without unduly limiting the beneficial uses of the practices giving rise to radiation exposure.

6.

1.5. Initial Nuclear Safety Package


On 30 January 2003, after receiving the opinion of the Group of Experts set up by Article 31 of the Euratom Treaty, the Commission adopted two proposals of Directives dealing respectively with the safety of nuclear facilities and the management of spent fuel and radioactive waste i.

After the European Economic and Social Committee gave its opinion on 26 March 2003, both proposals were forwarded to the Council. In accordance with the procedure in Article 31 of the Euratom Treaty, the Council requested the opinion of the European Parliament, which adopted opinions on the proposals in its plenary session on 13 January 2004.

At the same time, both proposals were discussed in the Council, under the Italian and Irish Presidencies. As a majority allowing the adoption or the rejection of both proposals was not possible to be obtained, it was agreed that Council conclusions would be worked out by consensus. Draft Conclusions on nuclear safety and on the safety of the management of spent nuclear fuel and radioactive waste were adopted by the Council in June 2004 i, leading to the creation of the Council Working Party on Nuclear Safety (WPNS). A detailed presentation of the procedural aspects related with the initial Nuclear Safety Package is included in the Impact Assessment Report i accompanying the present initiative.

The existing proposal of a Directive dealing with the safety of nuclear facilities will be withdrawn and replaced by the new proposal.

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2. CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT


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2.1. Stakeholders consultations on the necessity of a Community nuclear safety legislative framework


The current revised legislative proposal is the result of an extensive and continuous consultation process, initiated in 2004 during the Irish Presidency. The WPNS, the HLG and the European Nuclear Energy Forum continued work on this issue.

Throughout the elaboration process of the initial Nuclear Safety Package, a wide consultation with the stakeholders on the opportunity of setting up a nuclear safety legislative framework was carried out at the initiative of the Commission, supplementing the consultations resulting from the legislative procedure provided for in the Euratom Treaty (the opinions of the Group of experts set up by Article 31 of the Treaty and of the European Economic and Social Committee). Consultations were also undertaken with international organizations, such as the IAEA and the OECD Nuclear Energy Agency (NEA). The Commission took also advantage of its participation in various international meetings to present its plans for EU regulation in the field of nuclear safety.

The European Nuclear Energy Forum, established in 2007 and involving key decision-makers and organizations from national and EU levels, has already contributed to enhancing a better understanding on common approaches that are required in the further development of the safety of nuclear installations. The Conclusions of the Prague and Bratislava 2008 Forum meetings emphasised the Forum's strong support for the adoption of EU legislation on nuclear safety, based on 'common fundamental safety principles for nuclear installations'.

In addition, the technical background supporting the basic principles proposed in the current draft revised Directive was provided by the outcome of the activity of the different expert groups dealing with nuclear safety matters. Several different levels and types of activities have been developed at EU level, with the involvement of expert groups comprising representatives of the safety authorities of the Member States, which have actively contributed to the harmonisation of nuclear safety practices.

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2.2. Overview of the expert groups in the field of the harmonization of nuclear safety approaches at EU level


2.2.1. Nuclear Regulators’ Working Group (NRWG) and Reactor Safety Working Group (RSWG)

In order to pursue the objectives of the 1975 Council Resolution on the technological problems of nuclear safety, the Commission set up two expert groups dealing with nuclear installation safety. The NRWG, which met last in June 2005, includes representatives of nuclear regulatory authorities from EU Member States and Candidate States of Central and Eastern Europe. The RSWG, which included all the EU regulatory bodies and industry, was discontinued in 1998.

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2.2.2. CONCERTation on European Regulatory Tasks (CONCERT)


The CONCERT Group, formed in 1992, was a forum that brought together EU, Central and Eastern European Countries and Newly Independent States nuclear regulators to share experience and to enhance the progress of assistance and co-operation programmes in general. The group held its last meeting in 2005.

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2.2.3. WENRA


Special emphasis should be put on the activity carried on by WENRA, an organisation comprising the Heads and senior staff members of nuclear regulatory authorities from 17 European Countries.

In order to harmonise safety approaches, two working groups were launched with the mandate to analyse the current situation and the different safety approaches, compare individual national regulatory approaches with the IAEA Safety Standards, identify differences and propose a way forward to possibly eliminate the differences without impairing the final resulting level of safety.

In January 2006, reports on safety reference levels were published and subsequently revised in 2007 and 2008 i. WENRA members have defined many common safety reference levels for power reactors with a view to align national requirements by the year 2010. Any Community initiative in the field of nuclear safety should take advantage of the technical progresses achieved within WENRA. Moreover, the WENRA reports on the harmonization of safety approaches for nuclear power reactors were assessed by the WPNS which concluded that 'WENRA methodology is a systematic, documented and logical approach to harmonisation' .

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2.2.4. WPNS


Following the 2004 Council Conclusions on nuclear safety and safe management of spent fuel and radioactive waste, which call for an “ extensive consultation ” with stakeholders, a wide ranging consultation process was initiated, aiming to identify new instrument(s) that can contribute more effectively to further improving nuclear safety and the safety of the management of spent fuel and radioactive waste, in the framework of the Euratom Treaty and in line with the principles of better law making. As a result, the WPNS was established i.

The final WPNS Report i, comprising overall conclusions and recommendations, was approved by the Council on 13 December 2006. The detailed methodology, organisation of work and data collection, detailed results from data collection and analysis, and justification for the conclusions and recommendations are presented in the reports produced by the three established subgroups i. 70 experts from Member States and the Commission participated at the work of the WPNS. The conclusions of these Reports offer a sound technical background for the approach envisaged by the current draft Directive setting up a Community framework for Nuclear Safety.

13.

2.2.5. HLG


In 10 January 2007, the Commission adopted a draft Nuclear Illustrative Programme that proposed the establishment of a High Level Group on nuclear safety, waste management and decommissioning. Subsequently, this proposal has been endorsed and supported by all the highest EU fora (as reflected in the Conclusions of the Brussels European Council from March 2007 i, the Council Conclusions of May 2007 on Nuclear Safety and Safe Management of Spent Nuclear Fuel and Radioactive Waste i and in the 2007 European Parliament Report on 50 years of European nuclear energy policy i).

The HLG was formalised by the Commission Decision 2007/530/Euratom i in July 2007. The Decision mandates the HLG to assist the EU institutions in progressively developing common understanding and eventually additional European rules in the fields of the safety of nuclear installations and the safety of the management of spent fuel and radioactive waste.

The HLG comprises the Heads of the national regulatory or nuclear safety authorities of the 27 Member States. By setting up the HLG, the technical work of WENRA will be widened in a more formal framework, in association with representatives of the EU non nuclear energy countries.

The proposed draft Directive includes specific provisions on the actions to be implemented by the HLG, which will have a key role by supporting the definition of instruments to maintain and further improve nuclear safety throughout the Community. For this purpose, upon the adoption by the Council of the current Directive, the initial mandate of the Group, as set up in the Commission Decision 2007/530/Euratom will be amended by the Commission, in order to properly reflect its responsibilities in connection with the implementation of the Directive.

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2.3. Impact Assessment


The accompanying Impact Assessment updates the Impact Assessment related to the previous nuclear safety proposal included in the Nuclear Safety Package i, and it is based on the technical conclusions and recommendations identified in the WPNS Reports, as well as on the obligations and requirements set up in the CNS and on the principles of the IAEA Safety Fundamentals.

The Impact Assessment analyses four policy options : Policy option 0 consists in keeping the current situation unchanged; Policy option 1 envisages the elaboration of Community legislation establishing common safety standards for existing nuclear installations; Policy option 2 consists in the enacting Community legislation that sets up only a common framework aiming at achieving and maintaining a high uniform level of nuclear safety throughout the Community by recalling widely recognised nuclear safety principles, the subsequent implementing measures being elaborated by the HLG; Policy option 3 is built upon a set of internationally-recognised nuclear safety principles (approach proposed by Policy option 2), supplemented with additional safety requirements for new nuclear power reactors, which Member States are encouraged to develop in line with the principle of continuous improvement of safety, on the basis of the safety levels developed by WENRA and in close collaboration with the HLG. As a result, the assessment of the options showed that the most efficient solution for setting up a Community nuclear safety common approach is the one envisaged by Policy option 3. The Impact Assessment Report is accessible on……….

1.

LEGAL ELEMENTS OF THE PROPOSAL



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3.1. Summary of the proposed action


The present proposal aims at re-starting the process of establishing a common EU framework on nuclear safety with the objective of achieving and maintaining a high comparable level of nuclear safety throughout the Community, by replacing the corresponding initial proposal included in the Nuclear Safety Package. The proposal is anchored on the provisions of the CNS, which sets up a precise legal framework representing the foundation of a harmonised nuclear safety system and to which Euratom and all the EU Member States are Contracting Parties.

16.

3.2. Legal basis


The legal basis for this proposal is Article 31 of the Euratom Treaty, in connection with Article 32 thereof. Article 31 defines the procedure for the adoption of the basic safety standards provided for in Article 30 for the protection of the health of workers and the general public against the dangers arising from ionising radiation. Article 32 explicitly states that the basic standards might be supplemented in accordance with the procedure laid down in Article 31.

17.

3.3. Subsidiarity and proportionality


Nuclear energy plays an important role in the transition to a low carbon economy and reduces EU external supply dependency. The choice to include nuclear energy in the energy mix lies with the Member States. The role of the European Union is to ensure that this source of energy is developed while meeting the highest level of safety.

All the EU Member States are Contracting Parties to the CNS, which constitutes an internationally recognised common platform for nuclear safety development. The EU Member States have already implemented measures enabling them to achieve a high level of nuclear safety within the EU. However, because of the different historical backgrounds, legal frameworks, type and number of reactors and different approaches to regulation, common rules in the field of nuclear safety to be applied across the Community have not been yet established.

The approach of the current proposal allows Member States to fully exploit the subsidiarity principle as it creates a legislative framework for nuclear safety without being prescriptive as regards details. Moreover, the draft Directive aims to reinforce the role and the independence of the national regulatory bodies thereby building on their competencies, as well as the role of the national bodies in the implementation of the agreed measures. By means of the Directive, the principle of national responsibility for the safety of nuclear installations is fully adhered to, as for the safety of new nuclear power reactors, Member States are encouraged to develop additional safety requirements, in line with the continuous improvement of safety on the basis of the safety levels developed by WENRA and in close collaboration with the HLG. In addition, Member States retain the right to impose at national level more stringent safety measures than those provided for in the draft Directive.

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4. MAIN PROVISIONS OF THE PROPOSAL


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4.1. Responsibility and framework for the safety of nuclear installations (Article 3)


The article on responsibility for the safety of nuclear installations reflects one of the fundamental principles of nuclear safety, also enshrined in Article 9 of the CNS: the prime responsibility for the safety of nuclear installations, throughout their lifetime, rests with the holder of the license under the control of the regulatory body. Furthermore, the safety measures and controls to be implemented in a nuclear installation shall be decided only by the regulatory body and realised by the licence holder.

The second paragraph requires Member States to establish and maintain a legislative and regulatory framework for nuclear safety. This provision is already adhered to by all Member States and should not pose any difficulty for implementation.

20.

4.2. Regulatory bodies (Article 4)


The text reinforces the role and the independence of the national regulatory bodies, building on their competencies. In order to facilitate autonomous decisions giving priority to nuclear safety, the effective independence of the regulatory body from all organizations tasked to promote, operate nuclear installations or justify societal benefits, as well as its freedom from undue influence must be ensured. A similar provision already exists in the CNS (Article 8 paragraph 2). The regulatory body, provided with adequate authority, competence and financial and human resources to fulfil its responsibilities and duties, will be entrusted with the supervision and regulation of the safety of nuclear installations, as well as with ensuring of the implementation of safety requirements, conditions and regulations.

The regulatory body will have the responsibility of granting licences and monitoring their application on siting, design, construction, commissioning, operation or decommissioning of nuclear installations.

The regulatory body will have the duty to ensure that licence holder have staff in sufficient numbers and level of qualification to run the installations.

In order to continuously improve the regulatory infrastructure, the regulatory body and the national regulatory structure will be subject to periodic international peer reviews.

In the framework of this provision, the national regulatory bodies and the regulatory systems will be subject to regular international peer review missions by the IAEA International Regulatory Review Service (IRRS) missions, and subscribe to prepare at least a self assessment every ten years.

21.

4.3. Transparency (Article 5)


The provisions of Article 5 respond to the necessity ensure access to reliable information and to allow the public to participate to a transparent decision-making process.

22.

4.4. Safety requirements and regulations for nuclear installations (Article 6)


Article 6 reiterates and reinforces Member States' obligation to respect the IAEA safety fundamentals i as well as to observe the internationally agreed obligations and requirements of the CNS.

In addition, as regards the safety of new nuclear power reactors, Member States are encouraged to develop additional safety requirements, in line with the continuous improvement of safety on the basis of the safety levels developed by WENRA, and in close collaboration with the HLG.

In this context, it should be underlined that, once the Council has agreed on the text of the Directive, the Commission will adapt accordingly the mandate of the HLG as established by its founding Commission Decision.

23.

4.5. Obligations of licence holders (Article 7)


This article sums up the obligations of licence holders for fulfilling the requirements set up in Article 6 and emphasises their duties to establish and implement management systems and possess adequate financial and human resources for nuclear safety.

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4.6. Supervision (Article 8)


The nuclear safety assessments, investigations, control and enforcement actions of the regulatory body must be carried out throughout the whole lifetime of installations, including during decommissioning. This is another commonly agreed principle. In order to strengthen the powers of European regulators, the present Directive provides for extended regulatory powers in the interest of safety. In case of serious or repeated safety rules breaches, the regulatory body shall have the power to withdraw the operating licence and order the suspension of operations of any plant if it deems that safety is not fully guaranteed. The obligation of the assessment and verification of safety is also set up in Article 14 of the CNS.

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4.7. Nuclear safety expertise (Article 9)


The availability of nuclear safety experts is an extremely important issue which comes up at every international meeting concerned with nuclear safety. The past decades have not trained enough specialists, so that there is also the problem of aging of safety personnel and inspectors, of which many are approaching retirement. This is an area where the Community can assist with encouraging trans-national cooperation and training. The obligation to ensure the availability of sufficient and qualified staff is also recognised in Article 11 paragraph 2 of the CNS.

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4.8. Priority to safety (Article 10)


In line with the principle of priority of safety, Member States have the possibility to impose at national level more stringent safety measures than those provided for in the draft Directive.

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5. CONCLUSION


The Council is, therefore, requested to:

approve the attached proposal for a Council Directive (Euratom) setting up a Community framework for Nuclear Safety.