Legal provisions of COM(2013)343 - Amending Directive 2009/71/EURATOM establishing a Community framework for the nuclear safety of nuclear installations - Main contents
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| dossier | COM(2013)343 - Amending Directive 2009/71/EURATOM establishing a Community framework for the nuclear safety of nuclear installations. |
|---|---|
| document | COM(2013)343  |
| date | June 13, 2013 |
Article 1
(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 8 - a 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 8 - b 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 8 - c 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 8 - d 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 8 - e 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 8 - f 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 9 - a 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
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.