Legal provisions of COM(2004)526 - Basic obligations and general principles on the safety of nuclear installations

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dossier COM(2004)526 - Basic obligations and general principles on the safety of nuclear installations.
document COM(2004)526 EN
date September  8, 2004

Contents

Article 1 - Subject matter and scope

1. In order to ensure the protection of the general public and of workers against the dangers of ionising radiation from nuclear installations, this Directive supplements the basic standards laid down under Article 30 of the EAEC Treaty as regards the safety of such installations by setting out relevant basic obligations and general principles.

2. This Directive shall apply to all nuclear installations, including after the end of their operation, for which consideration of safety is required under the legislative and regulatory framework of the Member State concerned.

Article 2 - Definitions

For the purposes of this Directive the following definitions shall apply:

1) 'Nuclear installation' means any civilian facility and its associated land, buildings and equipment where radioactive materials are produced, processed, used, handled, stored or disposed of temporarily or permanently; this definition shall apply until the moment the facility is released from any radiological restrictions imposed upon it; it does not cover mineral extraction facilities and facilities only holding small quantities of radioactive materials such as sealed radioactive sources for medical, research and industrial purposes;

2) 'Nuclear safety' means the state achieved through measures taken with a view to the prevention of accidents or mitigation of accident consequences, resulting in protection of workers and public from undue radiation hazards arising from nuclear installations;

3) 'Common safety principles' means all the provisions set out in Articles 3 to 11 ;

4) 'Radioactive material' means any material that emits ionising radiation;

5) 'Ionising radiation' means the transfer of energy in the form of particles or electromagnetic waves of a wavelength of 100 nanometer or less or a frequency of 3 x 1015 Hertz or more capable of producing ions directly or indirectly;

6) 'Regulatory body' means any body or bodies, given the legal authority by each Member State to grant in that Member State licences and to regulate the siting, design, construction, commissioning, operation or decommissioning of nuclear installations;

7) 'Licence' means any authorisation granted by the regulatory body to the applicant to confer the responsibility for the siting, design, construction, commissioning, operation or decommissioning of nuclear installations;

8) 'Decommissioning' means all steps leading to the release from regulatory control of a nuclear installation, other than a disposal facility; those steps include the processes of decontamination and dismantling;

9) 'Radioactive waste' means radioactive material in gaseous, liquid or solid form for which no further use is foreseen by the Member State or by a natural or legal person whose decision is accepted by the Member State, and which is controlled as radioactive waste by a regulatory body under the legislative and regulatory framework of the Member State;

10) 'Practice' means a human activity that can increase the exposure of individuals to radiation from an artificial source, or from a natural radiation source where natural radionuclides are processed for their radioactive, fissile or fertile properties, except in the case of an emergency exposure.

Article 3 - Regulatory body

1. Each Member State shall establish a regulatory body and ensure that in discharging its duties on nuclear safety the functions of the regulatory body are effectively separated from those of any other body or organisation, whether private or public, concerned with the promotion or utilisation of nuclear energy. The regulatory body shall be provided with adequate authority, competence and financial and human resources to fulfil its assigned responsibilities.

2. The regulatory body shall supervise and regulate nuclear safety of nuclear installations and ensure the implementation of safety regulations. It shall grant licences and monitor application of the regulations on siting, design, construction, commissioning, operation or decommissioning of nuclear installations.

Article 4 - Responsibility for the safety of the nuclear installations

1. Member States shall take the necessary measures to ensure that the prime responsibility for the safety of a nuclear installation rests with the holder of the relevant license under the control of their regulatory bodies referred to in Article 3. The safety measures and controls to be implemented in a nuclear installation shall be decided solely by the regulatory body and the licence holder.

2. Each Member State shall establish and maintain a legislative and regulatory framework to govern the safety of nuclear installations. The legislative and regulatory framework shall provide for:

(a) the establishment of applicable national safety requirements and regulations;

(b) a system of licensing with regard to nuclear installations and the prohibition of the operation of any nuclear installation without a licence;

(c) a system of regulatory inspection and assessment of nuclear installations to ascertain compliance with applicable regulations and the terms of licences;

(d) the enforcement of applicable regulations and the terms of licences, including suspension, modification or revoking.

3. Member States shall take the appropriate measures to ensure that each holder of a license meets his responsibilities.

Article 5 - Safety in nuclear installations

Member States shall ensure that all reasonably achievable measures are implemented to ensure a high level of safety in nuclear installations.

In particular, Member States shall take all the appropriate steps:

(a) to establish and maintain effective arrangements in nuclear installations against potential radiological hazards in order to protect individuals and society from harmful effects of ionising radiation from such installations;

(b) to prevent accidents with radiological consequences and to mitigate such consequences, should they occur;

(c) to ensure the long term management of all radioactive materials, including radioactive waste and spent nuclear fuel, produced in the course of operation and decommissioning, in accordance with the basic standards for the protection of the general public and of workers against dangers arising from ionising radiation;

(d) to ensure effective information to and, where appropriate, consultation of their population, as well as the competent authorities of the States in the vicinity of nuclear installations under the jurisdiction of the Member State concerned, insofar as they are likely to be affected in the event of a radiological emergency at that installation, on issues related to safety of such nuclear installations.

Article 6 - Priority to safety

1. Member States shall take all appropriate measures to ensure that in the course of all practices directly related to nuclear installations due priority is given to nuclear safety.

2. The measures for operational protection of the population in normal circumstances pursuant to Article 44 of Directive 96/29/ Euratom shall take account of all aspects of the nuclear safety of installations.

Article 7 - Obligations of licence holders

1. Member States shall require the licence holders to operate their installations in accordance with the common safety principles set out in this Directive , with national safety requirements applicable to them, with the regulations laid down by the regulatory body and with any measures taken by the same regulatory body.

2. Member States shall require the licence holders to establish and implement quality assurance programmes commensurate with the nuclear safety relevance of the installations concerned, subject to at least verification by the regulatory body, with a view to providing confidence that specified requirements for all activities important to nuclear safety are satisfied throughout the life of nuclear installations.

3. Member States shall take the necessary measures for the allocation of responsibility for the decommissioning of nuclear installations, including in those cases where the parties originally responsible are no longer able to meet their commitments.

Article 8 - Inspection

Member States shall ensure that nuclear safety inspections are carried out by the regulatory body, or by experts designated by the regulatory body, in nuclear installations throughout their life, including during their decommissioning, and that the licence holder submits to such inspections.

Article 9 - Financial resources

Member States shall take the appropriate steps to ensure that adequate financial resources are available from the regulatory body and the operators to support the safety of nuclear installations throughout their life.

Article 10 - Nuclear safety expertise

1. Member States shall take the appropriate steps to ensure the availability of nuclear safety experts commensurate to the nuclear safety-related activities carried out under their jurisdiction. Member States shall require in particular that the regulatory body and the licence holders have appropriate staff at their disposal.

2. Member State shall ensure that appropriate curricula and opportunities for continuous theoretical and practical training are available, either in the Member State concerned or through transnational cooperation, for the personnel concerned in the safety of nuclear installations.

Article 11 - Emergency plans

1. Member States shall require the establishment of off-site as well as, in the case of Member States with nuclear installations under their jurisdiction, on-site emergency plans approved by their regulatory body, and regularly tested, to deal with operating incidents and accidents in order to reduce the possible effects on its population of any radiological emergencies resulting from operation of nuclear installations.

2. Each Member State shall take the appropriate steps to ensure that, insofar as they are likely to be affected by a radiological emergency, its own population and the competent authorities of the States in the vicinity of nuclear installations under its jurisdiction are provided with appropriate information for emergency planning and response.

3. Member States shall require the license holder to notify the regulatory body forthwith of any incidents significant to safety and of the corrective measures taken in response.

Article 12 - Committee of Regulatory Authorities

1. A Committee of Regulatory Authorities (hereinafter 'the Committee') is hereby established

2. The Committee shall be composed of representatives of the regulatory bodies designated by each Member State.

3. The Committee shall adopt its rules of procedure and designate a chairman from among its members. The Commission shall act as the Secretariat of the Committee.

4. The Committee shall:

(a) encourage exchange of best practice among regulatory authorities, with a view to ensuring progressive harmonisation of approaches to safety, in the framework of this Directive;

(b) advise the Commission on all matters concerning nuclear safety, including the summary reports submitted as per Article 14;

(c) define guidelines on the content, form, structure and timetable for national reports as in Article 13, with a view to ensuring, as much as possible, coherence with the reports which must be prepared under Article 5 of the Convention on Nuclear Safety;

(d) assess the national reports prepared under Article 13, give an opinion, possibly containing recommendations to the Member State concerned, on each of the national reports, on request of the Commission.

Article 13 - National reports

1. Member States shall submit a report to the Commission on the measures taken to fulfil their obligations under this Directive and on the safety situation in nuclear installations under their jurisdiction. Member States may indicate which parts of the report shall be considered confidential. The Commission shall forward those reports to the Committee.

2. The first report shall be submitted within [three] years from the date provided for in Article 15 (1) and thereafter at the same intervals as the reports to be drawn up pursuant to Article 5 of the Convention on Nuclear Safety attached to Decision 1999/819/Euratom in accordance with the guidelines drawn up by the Committee.

Article 14 - Summary reports

The Commission shall submit regular summary reports to the European Parliament and to the Council in conformity with the timetable defined in Article 13, paragraph 2 on the application of this Directive and on the overall progress made on nuclear safety in the Community, based on the reports submitted in accordance with Article 13, paragraph 1, subject to the confidentiality requirements concerned.

Article 15 - Transposition

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [two years after the date referred to in Article 16] at the latest.

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.

3. 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.

Article 16 - Entry into force

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

Article 17 - Addressees

This Directive is addressed to the Member States.