EXPLANATORY MEMORANDUM

1. Context

1.1. Background and objectives

Exposure to ionising radiation results in a health detriment. In normal situations doses are very low so that there is no clinically observable tissue effect, but there still is a possible late effect, cancer in particular. It is assumed that there is no dose threshold for this effect: any exposure, however small, can be the cause of cancer later in life. It is further assumed that the probability of occurrence of a late effect is proportional to the dose. This calls for a specific approach in radiation protection based on the three principles of justification, optimisation and dose limitation, which are the cornerstones of the system of protection established many decades ago by the International Commission on Radiological Protection (ICRP).

Euratom legislation has always followed the recommendations of the ICRP. This highly respected scientific organisation has recently issued new guidance on the system of radiation protection (Publication 103, 2007). While preserving the three pillars of the system, the ICRP sets out in more detail the application of the principles throughout any exposure situation and irrespective whether the source of radiation is man-made or natural. Radiation protection indeed covers not only exposures resulting from the operation of radiation sources (planned exposure situations), but also emergency exposure situations, for instance resulting from a nuclear accident, and a range of other situations, in particular those involving exposure to natural radiation sources, termed ‘existing exposure situations’. The ICRP has also updated the methodology for assessment of the effective dose as well as the application of dose limits, in the light of the latest scientific information.

A large proportion of workers in industries processing naturally occurring radioactive materials (NORM) receive doses above the dose limit for members of the public, but still do not benefit from protection as occupationally exposed workers. This anomaly is not sustainable, so the ICRP’s new Recommendations aim to integrate natural radiation sources within the overall system. Already in 1996, the current Euratom legislation[1] had introduced requirements for work activities involving natural radiation sources. These were put together in a separate Title rather than being integrated within the overall radiation protection framework. In addition, maximum flexibility was offered to Member States to decide for instance which NORM industries were of concern. This has led to wide differences in controlling NORM industries and in protecting workers in these industries. This situation is not compatible with Euratom’s role in setting uniform standards.

Exposure to indoor radon, a natural radioactive noble gas entering dwellings from the soil below, is far more important than exposure from any other radiation source. Recent epidemiological studies have confirmed that lung cancer may be caused by exposure to radon, and WHO[2] now ranks this as a major health issue[3]. Exposure to radon in dwellings was addressed in 1990 in a Commission Recommendation. The confirmed causation of lung cancer by exposure to radon calls for strengthening radon mitigation policies in Europe through binding requirements. Radioactivity in building materials has been included in the Construction Products Directive[4], but this has still not led to any corresponding standards being adopted by the European Committee for Standardisation (CEN). The revision of the Basic Safety Standards (BSS) Directive will not only address the recycling of residues from NORM industries into building materials, but also ensure coherent and harmonised protection against other building materials with enhanced levels of radioactivity.

In addition to the health protection of people, the ICRP radiation protection system now addresses the protection of biota against exposure to ionising radiation. While it is generally assumed that the exposure of biota does not call for additional measures, this assumption now needs to be demonstrated through compliance with criteria and on the basis of an agreed methodology.

There is a significant body of Euratom legislation addressing different radiation protection issues defined as basic safety standards in the Euratom Treaty. As these issues have developed over a long period of time, there are inevitably quite a few inconsistencies between different acts and also obsolete references as a result of updated legislation. These inconsistencies need to be resolved, in line with the Commission’s policy for simplification of European legislation.

The problem can be summarised as follows:

– Scientific progress is not fully reflected in present legislation;

– There are inconsistencies between the existing pieces of legislation;

– The scope of the present legislation does not fully cover natural radiation sources or the protection of the environment.

This translates into four specific objectives:

– to introduce the necessary subject-matter amendments in order to respond to the latest scientific data and operational experience,

– to clarify the requirements and to ensure coherence within the body of European legislation,

– to ensure coherence with the international recommendations,

– to cover the whole range of exposure situations and categories of exposure.

1.2. Subsidiarity

According to Article 2(b) of the Euratom Treaty ‘… the Community shall, as provided in this Treaty … establish uniform safety standards to protect the health of workers and of the general public and ensure that they are applied’. Accordingly, in the Treaty’s preamble, the Member States declare that they are ‘resolved to create the conditions necessary for the development of a strong nuclear industry’ and also ‘anxious to create conditions of safety necessary to eliminate hazards to the life and health of the public’. Euratom is mandated to ‘establish uniform safety standards to protect the health of workers and of the general public and ensure that they are applied.’ Therefore, Euratom’s competence to regulate in the field of health protection against ionising radiation is explicitly recognised by the Euratom Treaty.

The exclusive nature of Euratom’s legislative powers under Articles 30 and 31 of the Euratom Treaty does not in principle require the application of the principle of subsidiarity. These Articles require the Commission to seek for its legislative proposals the opinion of a Group of Experts designated by the Euratom Scientific and Technical Committee.

1.3. Current legislation

Following the entry into force of the Euratom Treaty, a comprehensive set of legislation establishing basic safety standards has been enacted on the basis of Article 31 of the Treaty.

The main pillar of that legislation is 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 (Euratom BSS Directive). Further legislation based on Article 31 of the Euratom Treaty comprises:

- Council Decision 87/600/Euratom of 14 December 1987 on Community arrangements for early exchange of information in the event of a radiological emergency;

- Council Regulation 3954/87/Euratom of 22 December 1987 laying down maximum permitted levels of radioactive contamination of foodstuffs and of feedingstuffs following a nuclear accident or any other case of radiological emergency and the related legislative acts, Commission Regulation 944/89/Euratom of 12 April 1989 laying down maximum permitted levels of radioactive contamination in minor foodstuffs following a nuclear accident or any other case of radiological emergency, and Commission Regulation 770/90/Euratom of 29 March 1990 laying down maximum permitted levels of radioactive contamination of feedingstuffs following a nuclear accident or any other case of radiological emergency[5];

- Council Directive 89/618/Euratom of 27 November 1989 on informing the general public about health protection measures to be applied and steps to be taken in the event of a radiological emergency (Public Information Directive);

- Commission Recommendation 90/143/Euratom of 21 February 1990 on the protection of the public against indoor exposure to radon;

- Council Directive 90/641/Euratom of 4 December 1990 on the operational protection of outside workers exposed to the risk of ionising radiation during their activities in controlled areas (Outside Workers Directive);

- Council Regulation 1493/93/Euratom of 8 June 1993 on shipments of radioactive substances between Member States;

- Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure, repealing Directive 84/466/Euratom of 3 September 1984 (Medical Directive);

- Commission Recommendation 2001/928/Euratom of 20 December 2001 on the protection of the public against exposure to radon in drinking water supplies;

- Council Directive 2003/122/Euratom of 22 December 2003 on the control of high-activity sealed radioactive sources and orphan sources (HASS Directive);

- Council Directive 2006/117 of 20 November 2006 on the supervision and control of shipments of radioactive waste and spent fuel;

- Council Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations.

The BSS Directive have been regularly updated in 1962, 1966, 1976, 1980, 1984 and 1996, taking account of advances in scientific knowledge of the effects of ionising radiation in line with the recommendations of the ICRP and on the basis of operational experience. Medical exposures have been included in specific legislation since 1984. Specific problem areas are covered in three ‘associated directives’ – the High-Activity Sealed Radioactive Sources (HASS) Directive, the Outside Workers Directive and the Public Information Directive. An analysis of the legislation enacted under Article 31 of the Euratom Treaty reveals that the Medical Directive, the HASS Directive, the Outside Workers Directive and the Public Information Directive are closely linked with BSS Directive 96/29, in that they develop further the requirements of the BSS Directive or refer to different provisions of the BSS Directive. For this reason the proposal for a new basic safety standard Directive will cover the subject matter and scope of these Directives.

The Commission will propose separately a Directive laying down requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption (COM(2011)385). This Euratom Directive will replace an existing Directive 98/83/EC with regard to its application to radioactive substances and complement it with technical annexes on sampling frequencies, methods of analysis and detection levels. The substance matter of this Directive is such that it could be incorporated in a recast with the basic safety standards at an appropriate point in time. At this stage however, since the Directive is intended to merely transpose existing requirements under EC Treaty legislation, in such a way as to avoid any interpretation as to a possible change in substance, it is considered more appropriate not to incorporate it at this stage in a proposal for a revised Basic Safety Standards Directive. In addition, at the time the Article 31 Group of Experts gave its opinion on the revised Basic safety standards Directive, there was still discussion whether a Directive on radioactive substances in water intended for human consumption should be based on Euratom Treaty or EC Treaty. In these circumstances it was decided to proceed with the proposal for a revised Basic Safety Standards Directive as agreed upon in February 2010 by Article 31 Group of Experts.

The other legislation based on Article 31 of the Euratom Treaty, as discussed in the Impact Assessment Report, either uses a different instrument, or the scope is essentially outside radiation protection or the legislation is specific to certain types of installation.

1.4. Simplification

In 2005 the European Commission published ‘Implementing the Community Lisbon programme: A strategy for the simplification of the regulatory environment: the better regulation initiative’ (COM/2005/535 final) as a response to the European Parliament’s and Council’s requests to simplify EU legislation and enhance its quality. This initiative is the basis for attempting the consolidation of the five Directives mentioned above. It is neither feasible nor useful to recast these Directives with the other pieces of legislation under Title II, Chapter 3 of the Euratom Treaty.

1.5. International context

The International Basic Safety Standards reflect an international consensus on what constitutes a high level of safety for protecting people and the environment from the harmful effects of ionising radiation. They are approved by the IAEA Board of Governors and are non-binding in nature. The main document on radiation protection is Safety Standards No 115 ‘International Basic Safety Standards for Protection against Ionising Radiation and for the Safety of Radiation Sources’, IAEA, 1996. In 2006, the IAEA, together with other international organisations (FAO, ILO, the NEA/OECD, PAHO and WHO), embarked upon the revision of Safety Standards No 115. This ongoing activity is also driven by the new ICRP Recommendations in Publication 103, published in 2007.

The European Commission has cooperated closely with the IAEA and other international organisations on the revision of the International Basic Safety Standards. However, it should be emphasised that the Euratom Basic Safety Standards Directive is not a means to confer legally binding status on the international requirements. There are two main reasons why referring to or incorporating the international BSS in European legislation is not feasible. On the one hand, the language of the international BSS does not conform to EU legal drafting rules. The international requirements are also sometimes far too detailed and go beyond the idea of ‘basic’ standards in the Euratom Treaty. The requirements of the Euratom BSS also need to take into account internal market rules. On the other hand, the international BSS allow for the fact that countries throughout the world, with different levels of regulatory and technological infrastructure, must be able to comply with them. The European legislation is more ambitious. Euratom is bound by the Treaty to establish uniform basic safety standards. Incorporating the international BSS in a European act is hence not only difficult, but would also be at odds with the major role played by Euratom since 1959 and the significant body of legislation that has already been built up. Nevertheless, the Commission pursues the largest possible coherence between Euratom and international standards, and envisages the eventual sponsorship of the latter on behalf of Euratom.

2. Consultation of interested parties and impact assessment

2.1. Interested parties

The Commission (DG ENER) has initiated and supported several projects and studies on specific radiation protection issues, the results of which have been published in the Radiation Protection Series of the European Commission[6]. The various projects, studies and conferences identify challenges to the implementation of the current radiation protection legislation and problem areas that are not sufficiently covered by the current system of protection.

In 2009, the Commission launched a consultation on a ‘proposal for new requirements on natural radiation sources in the Basic Safety Standards Directive’. The Working Party ‘Natural Sources’ of the Article 31 Group of Experts proposed a comprehensive approach to the regulation of NORM industries, radon and building materials. This document was published on the Commission website and was also highlighted on the EANNORM website[7]. The consultation ran from 02 February 2009 to 20 April 2009.

The revision of the Euratom Basic Safety Standards has benefited from continuous interaction with two organisations representing major stakeholders, namely the Heads of European Radiological Protection Competent Authorities (HERCA) and the International Radiation Protection Association (IRPA). An outline of the revision of the BSS was presented to HERCA at meetings in December 2008 and 2009 as well as in June 2010. The response of the radiation protection authorities was positive, and HERCA did not raise any important issue calling for changes in the approach. The revision has been presented at the International IRPA Congress (Buenos Aires 2008) and at European congresses organised by IRPA (Brasov, 2006, Helsinki 2010) as well as at annual meetings of the European IRPA societies. The European IRPA branch has set up a working party to collect input from their societies on the ongoing revision of both the international and Euratom BSS. There was also regular contact with the European Atomic Forum (FORATOM) which represents the stakeholders from the nuclear industry.

The key interaction with stakeholders is through the Article 31 Group of Experts, i.e. the experts to be consulted under Article 31 of the Euratom Treaty. In February 2010, the Group of Experts issued an opinion on the possible revision of European legislation in the form of a draft Directive. This text is the fruit of intensive work by the working parties of the Group of Experts, taking into account the studies conducted by the Commission as well as other sources of information (conferences, networks).

The draft proposed by the Commission is to a large extent the same as the draft on which the Article 31 Group of Experts' Opinion was based. Only some editorial corrections have been made and a few definitions added. The Experts left it for the Commission to decide whether the definition of HASS sources should remain the same as in the current Directive 2003/122/Euratom or whether the definition should be aligned with the IAEA Code of Conduct on the safety and security of radioactive sources. The Commission has opted for the latter.

In its Opinion the Article 31 Group of Experts also suggests maintaining the text of Article 54 of Directive 96/29/Euratom, which allows Member States to opt out from the uniform Basic Safety Standards and introduce stricter dose limits to reflect possible new scientific findings after the adoption of the directive. This would jeopardise the implementation of the Euratom Treaty which requires establishment of uniform standards. The proposed text of the directive therefore does not include such clause. In its judgement of 25 November 1992 in the case Commission of the European Communities v Kingdom of Belgium (Case C-376/90[8]), the Court stated that 'in the absence of an express provision to the contrary, the Directive must be interpreted as allowing the Member States to set, …, stricter dose limits'. In this respect, an explicit statement on the uniformity of the standards has been introduced in the proposed text of the revised Basic Safety Standards Directive.

2.2. Impact assessment

A comprehensive impact assessment was made to evaluate the possible options for reaching the objectives:

1. to bring the health protection of workers, the public and patients in line with latest scientific data and operational experience,

2. to streamline existing EU legislation in the field of radiation protection,

3. to ensure coherence with international standards and recommendations,

4. to cover the whole range of exposure situations, including exposure to natural radiation sources at home, as well as the protection of the environment.

In the light of these objectives, the impact assessment report considers a broad range of options both with regard to the extent of the consolidation with other legislation and with regard to scope and substance of the incorporated legislation:

Option 1: Maintaining the status quo of existing legislation.

Option 2: Revision of Basic Safety Standards and Medical Directive. This option envisages changes in the two Directives with the aim to align them with the latest ICRP recommendations and with the advance of the scientific knowledge.

Option 3: Revision and consolidation of Basic Safety Standards and Medical Directive, and integration of the Outside Workers Directive, the Public Information Directive and the High Activity Sealed Sources Directive. Non-legislative measures will address natural radiation issues and the protection of non-human species. This option offers a revision of the Basic Safety Standards Directive by extending the requirements to medical exposure, public information, outside workers exposure and high-activity sealed sources. Within this policy option, the BSS Directive 96/29 and the related legislative acts (Medical Directive 97/43/Euratom, Outside Workers Directive 90/641/Euratom, HASS Directive 2003/122/Euratom, Public Information Directive 89/618/Euratom, Commission Recommendation 90/143/Euratom) will merge and the requirements of BSS Directive and of Medical Directive will at the same time be upgraded to the latest scientific knowledge and regulatory experience.

Option 4: Revision of the Basic Safety Standards Directive and broadening the scope to cover exposure to natural radiation at home. With this option, a comprehensive approach to the management of exposures due to natural radiation sources will be incorporated within the overall set of requirements of the Euratom BSS. The requirements will reflect the distinction between planned and existing exposure situations, as made in ICRP Publication 103. While occupational exposure to natural radiation sources (as well as public exposure from residues or effluents from NORM industries) is already considered in Options 1 to 3, the exposures to natural radiation sources that will explicitly be incorporated relate to public exposure in the domestic environment.

Option 5: Revision of the Basic Safety Standards Directive and broadening the scope to cover protection of non-human species. The subject matter and general purpose of the BSS Directive 96/29/Euratom is the health protection of the population and workers against dangers of ionising radiation. This Directive applies to the protection of the human environment, but only as a pathway from environmental sources to the exposure of man. In line with the new ICRP Recommendations, it will be complemented with specific consideration of the exposure of biota in the environment as a whole. The aim would be to require Member States to consider suitable protection of non-human species in their radiation protection legislation.

Option 6: Revision and consolidation of the Basic Safety Standards Directive and Medical Directive, integration of the Outside Workers Directive, the Public Information Directive and the High Activity Sealed Sources Directive, and broadening the scope to cover public exposure to natural radiation and protection of non-human species. This option includes all the elements of Option 3 (revision of the Basic Safety Standards Directive and integration of the other four Directives). The revision of the Basic Safety Standards includes all identified issues, and broadens the scope to include the whole range of exposure situations, including indoor public exposure to radon and to building materials, and all categories of human and non-human exposures.

The effectiveness of the proposed options is assessed towards the objectives, the efficiency of the additional requirements in terms of their health and environmental impact, economic benefit and administrative cost, and the coherence of the Directive with overall Euratom and EU legislation. The amendments to the Basic Safety Standards and to the Medical Directive will have an important impact in the following areas:

- Social and health impact: The social impact relates to providing adequate protection to workers in NORM industries. The health impact will be most noticeable with regard to medical exposures, in particular in preventing unnecessarily frequent or high-dose radiological examinations (for instance CT scans) of patients leading to increased cancer incidence in future. Specific professional groups (for instance cardiologists) will benefit from the reduction of the dose limit for the lens of the eye and avoid contracting radiation-induced cataract.

- Economic impact: While it is not possible at this stage to make a quantified economic assessment, NORM industries will benefit from the harmonisation of requirements between Member States.

- Administrative cost: While the principle of protection optimisation, calling for doses to be ‘as low as reasonably achievable’ (ALARA), taking social and economic factors into account, is key to ensuring a proper cost-benefit balance in operational radiation protection, the new concept of a ‘graded approach’ extends this principle to enhance the effectiveness of regulatory oversight and reduce the administrative cost to industries.

Additional amendments introduced in the three other Directives are the following:

- harmonisation of the definition of high-activity sealed radioactive sources (HASS) with the international standards;

- specific requirements for the protection of outside workers with a clear definition of the responsibilities of their employers and the undertakings conducting the practices in which they are exposed;

- requirements for informing the public before and during an emergency, within the overall revised scope for the management of emergency exposure situations.

Merging the five Directives is a major achievement in terms of the coherence of Euratom legislation. The restructuring required to accommodate this broader scope of the BSS Directive further improves the clarity of the text and ensures better operational implementation of the requirements.

The broader scope of the new Directive entails further substantial amendments:

With regard to ‘existing exposure situations’, reference levels are given for indoor radon concentrations and for external exposure from building materials. Member States will be required to establish a comprehensive and transparent Radon Action Plan, adjusted to national needs and to the geological features of different regions. Harmonised requirements for building materials will permit further standardisation under the Construction Products Directive (Council Directive 89/106/EEC). While consumers and the building professions will benefit from the monitoring and labelling of materials, the administrative burden on industry will be kept to a minimum by the proper choice of reference levels and the list of types of materials deemed to be of concern.

Relevant requirements in the Euratom BSS for the protection of non-human species will allow Member States to incorporate this in national environmental policies, in a way which is coherent with current approaches to health protection against ionising radiation. The environmental impact assessment of these new requirements relates essentially to the prevention of environmental damage in case of an accident. For the normal operation of an installation it is rather a demonstration that there is no impact to the environment.

3. Legal elements of the proposal

The recast of five Directives yields a voluminous single Directive, with over 100 articles and numerous annexes. In view of the extent and complexity of the changes, a formal recast procedure is not pursued. It is not possible to point to each and every element of the proposal. The following sections give a summary description of the main features of each chapter.

3.1. Chapter I: Subject matter and scope

This chapter defines the scope of the new Directive (general purpose of the Directive across different categories of exposure and different exposure situations and specific purposes resulting from integration of the requirements for high-activity sealed radioactive sources and for public information, and the exclusion of non-controllable exposures). The scope is broadened to include the exposure of space crew to cosmic radiation, domestic exposure to radon gas in indoor air, external exposure to gamma radiation from building materials, and the protection of the environment beyond environmental pathways leading to human exposure.

3.2. Chapter II: Definitions

This chapter includes all definitions given in the earlier Directives, with some adjustments to resolve inconsistencies as well as to adjust to the new terminology introduced in ICRP Publication 103 and in the draft International Basic Safety Standards.

3.3. Chapter III: System of radiation protection

This title includes the general principles of radiation protection: justification, optimisation and dose limitation. It explains the more prominent role of dose constraints and reference levels in the process of optimisation, with Annex I giving the bands of reference levels proposed by the ICRP for existing and emergency exposure situations. The dose limits are not modified, except for a uniform definition of the annual occupational dose limit (no averaging over 5 years) and a lower organ dose limit for the lens of the eye, as recommended by the ICRP. The new Directive no longer includes the technical measurements entering into the definition of the effective dose and other factors entering into the assessment of doses, but refers to ICRP Publication 103 for this purpose. In addition, the Directive no longer includes the long lists of radionuclide-specific dose coefficients (doses per unit intake by ingestion or inhalation), but will refer to a forthcoming consolidated publication of the ICRP which can be downloaded free of charge.

3.4. Chapter IV: Requirements for radiation protection education, training and information

This chapter brings together the miscellaneous requirements governing education and training in the different Directives and includes provisions for recognition of the ‘Radiation Protection Expert’ and ‘Medical Physics Expert’.

3.5. Chapter V: Justification and regulatory control of practices

The application of the principle of justification remains a national responsibility. Specific attention is given to the justification of practices involving the deliberate exposure of humans for non-medical imaging (e.g. security screening in airports).

The regime for regulatory control is now presented as a three-tier system (notification, registration, licensing), replacing the earlier two-tier system of reporting and ‘prior authorisation’. A more detailed list of which types of practice are subject to either registration or licensing is given. As part of the concept of a ‘graded approach’ to regulatory control, there is explicit provision for the specific exemption of practices (from notification and from authorisation) at national level. The default values for exemption on the basis of activity concentrations are now taken from IAEA Safety Guide RS-G-1.7. The same default values apply to release from regulatory control (clearance levels), but allow for specific values in European guidance. Member States will be allowed to keep default clearance levels in current national legislation, and to keep the existing exemption values for moderate amounts of material. Details of exemption criteria and exemption and clearance levels are given in Annex VI.

This chapter also includes more precise requirements on the information to be provided with a licence application (the issuing of discharge authorisations for radioactive airborne or liquid effluent is covered in Chapter VIII).

3.6. Chapter VI: Protection of workers, apprentices and students

This title includes, with little amendment, the provisions on occupational exposure in Directive 96/29/Euratom. It also includes the specific requirements in the Outside Workers Directive, and introduces a clear allocation of responsibilities between the employer and the undertaking where the practice is conducted. The data system for individual radiological monitoring of exposed workers and the minimum set of data to be communicated for outside workers has been updated in the light of recommendations by HERCA.

No distinction is made between the management of occupational exposures in NORM industries and other practices, but the former will benefit from a graded regulatory approach on the basis of prevailing exposures and their potential to increase with time.

This chapter now covers occupational exposure in all exposure situations, which provides more explicit protection for emergency workers as well as for workers exposed to high levels of indoor radon in their workplace.

3.7. Chapter VII: Protection of patients and other individuals subjected to medical exposure

This chapter includes the relevant requirements from the Medical Directive, but strengthens them, in particular with regard to:

- the application of the justification principle;

- information to patients on the health risks and benefits;

- information on doses;

- diagnostic reference levels;

- involvement of the Medical Physics Expert;

- prevention of accidental and unintended medical exposures.

3.8. Chapter VIII: Protection of members of the public

This chapter includes the public exposure requirements in Directive 96/29/Euratom, with more explicit consideration of the issuing of discharge authorisations for radioactive effluent (also with reference to Commission Recommendation 2004/2/Euratom).

The section on emergency exposure situations includes the requirements of the Public Information Directive.

The section on existing exposure situations addresses indoor exposure to radon, with a somewhat lower maximum reference level for existing dwellings than in Commission Recommendation 90/143/Euratom, in line with ICRP and WHO recommendations. It also includes requirements for the classification of building materials on the basis of a radioactivity index and a uniform reference level for the annual dose resulting from residence in a building constructed with such materials.

3.9. Chapter IX: Protection of the environment

This chapter, in line with the broader scope of the Directive as in the International Basic Safety Standards, aims to provide a means to demonstrate compliance with environmental criteria. While the ICRP has published a methodology for dose assessment for biota, a publication on the application of criteria is still awaited. Pending such further guidance, it is up to national authorities to assess the doses to representative animals and plants in terms of protection of the ecosystem.

Appropriate technical measures also need to be taken to avoid the environmental consequences of an accidental release and to monitor existing levels of radioactivity in the environment, from the perspectives of both environmental protection and human health.

3.10. Chapter X: Requirements for regulatory control

This chapter includes all the responsibilities of the regulatory authorities in all exposure situations. A clear structure is provided by the following sections:

- Institutional infrastructure;

- Control of sealed radioactive sources (with Annexes II, XII, XIII, XIV, XV incorporating different aspects of the Directive on High-Activity Sealed Radioactive Sources);

- Orphan sources (with new requirements with regard to metal contamination);

- Emergency exposure situations (establishment of an emergency management system and international cooperation, while requirements for the protection of workers and members of the public in an emergency exposure situation are addressed in Chapters V and VIII, respectively);

- Existing exposure situations (general provisions for the management of contaminated areas, radon action plan);

- System of enforcement (inspection programme and response to deficiencies).

The first section on ‘institutional infrastructure’ calls for a clear definition of the responsibilities of different authorities. The Commission is to receive periodically updated information and publish this in the Official Journal. This section also defines the responsibilities of the ‘Radiation Protection Expert’, the ‘Radiation Protection Officer’ (in the current BSS these concepts were merged within the function of ‘Qualified Expert’) and the ‘Medical Physics Expert’.

3.11. Chapter XI: Final provisions

The transposition of the new Directive into national law should not require a major legislative effort, so a 2-year transposition deadline is deemed sufficient. Specific new features, such as the protection of the environment, can be transposed later.

In line with the Euratom Treaty, the Basic Standards are to be uniformly applied in the Member States, though without prejudice to those requirements for which flexibility is clear from the wording of the text. However, dose limits, default exemption values, the reference level for building materials, etc. are explicitly intended for uniform transposition and application.

4. Budgetary implications

There are no implications for the EU budget.

2011/0254 (NLE)

Proposal for a

COUNCIL DIRECTIVE

laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation

THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the 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, and after having consulted the European Economic and Social Committee,

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

Having regard to the opinion of the European Parliament,

Whereas:

(1) Article 2(b) of the Treaty provides for the establishment of uniform safety standards to protect the health of workers and the general public and Article 30 of the Treaty defines ‘basic standards’ for the health protection of workers and the general public against the dangers arising from ionising radiations.

(2) In order to perform its task, the Community laid down basic standards for the first time in 1959 pursuant to Article 218 of the Treaty by means of the Directives of 2 February 1959 laying down the basic standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation[9]. The Directives have been revised several times, most recently in 1996 by 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 ionising radiation[10] which repealed the earlier Directives.

(3) Directive 96/29/Euratom establishes the basic safety standards. This Directive applies to normal and emergency situations and has been supplemented by more specific legislation.

(4) Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure and repealing Directive 84/466/Euratom [11], Council Directive 89/618/Euratom of 27 November 1989 on informing the general public about health protection measures to be applied and steps to be taken in the event of a radiological emergency[12], Council Directive 90/641/Euratom of 4 December 1990 on the operational protection of outside workers exposed to the risk of ionising radiation during their activities in controlled areas[13] and Council Directive 2003/122/Euratom of 22 December 2003 on the control of high-activity sealed radioactive sources and orphan sources[14] cover different specific aspects complementary to Directive 96/29/Euratom.

(5) Over time, definitions used in that legislation have evolved and been adjusted to the specific scope, however many requirements laid down therein fit in the original context at the time of adoption of that legislation but cannot be extended for use in Directive 96/29/Euratom.

(6) The Group of Experts appointed by the Scientific and Technical Committee has advised that the basic safety standards, established according to Articles 30 and 31 of Euratom Treaty should take into account the new recommendations of the International Commission on Radiological Protection (ICRP), in particular those in Publication 103 (2007)[15], and should be revised in the light of new scientific evidence and operational experience.

(7) This Directive should follow the situation based approach introduced by ICRP Publication 103 and distinguish between existing, planned and emergency exposure situations. Taking into account this new framework the Directive should cover all exposure situations and all categories of exposure, namely occupational, public and medical exposures.

(8) A new methodology introduced by ICRP to calculate doses based on the latest knowledge on radiation risks should also be taken into account in this Directive.

(9) The current annual dose limits for occupational and public exposure are maintained. However, there should be no further need for averaging over five years, except in special circumstances specified in national legislation.

(10) New scientific information on tissue effects calls for the optimisation principle to be applied to organ doses as well, where appropriate, in order to keep doses as low as reasonably achievable. The directive should also follow new ICRP guidance on the organ dose limit for the lens of the eye in occupational exposure.

(11) Industries processing naturally occurring radioactive material extracted from the earth’s crust subject workers and, if material is released into the environment, the public to increased radiation exposure.

(12) Protection against natural radiation sources, rather than being addressed separately in a specific title, should be fully integrated within the overall requirements. In particular, industries processing materials containing naturally occurring radionuclides should be managed within the same regulatory framework as other practices.

(13) The new requirements on radioactivity in building materials should allow for the free circulation of building materials.

(14) Recent epidemiological findings from residential studies demonstrate a lung cancer risk from exposure to indoor radon at levels of the order of 100 Bq m-3. The new concept of exposure situations allows the provisions of Commission Recommendation 90/143/Euratom on the protection of the public against indoor exposure to radon[16] to be incorporated in the binding requirements of the Basic Safety Standards while leaving enough flexibility for implementation.

(15) The exposure of aircrew to cosmic radiation should be managed as a planned exposure situation. The operation of spacecraft should come under the scope of this Directive and should be managed as a specially authorised exposure.

(16) The health protection of the general public allows for the presence of radioactive substances in the environment. In addition to direct environmental exposure pathways, consideration should be given to the protection of the environment as a whole, including the exposure of biota, within a comprehensive and coherent overall framework. As far as mankind is part of its environment, this policy benefits to long term health protection.

(17) In the medical area, important technological and scientific developments have led to a notable increase in the exposure of patients. In this respect, the Directive should emphasise the need for justification of medical exposure, including the exposure of asymptomatic individuals, and should strengthen the requirements concerning information to be provided to patients, the recording and reporting of doses from medical procedures, the use of diagnostic reference levels and the availability of dose-indicating devices.

(18) Accidental and unintended medical exposures are a source of continuing concern. Their prevention and follow-up, should they occur, need to be fully addressed. In this respect, the role of quality assurance programmes, including risk analysis in radiotherapy, to avoid such incidents should be emphasised, and recording, reporting, analysis and corrective action should be required in such cases.

(19) The so-called ‘medico-legal’ exposures introduced in Directive 97/43/Euratom have now been clearly identified as the deliberate exposure of individuals for other than medical purposes, or ‘non-medical imaging exposures’. Such practices need to be placed under appropriate regulatory control and should be justified in a similar way as for medical exposures. However, a different approach is needed on the one hand for procedures implemented by medical staff using medical equipment and on the other hand for procedures implemented by non-medical staff using non-medical equipment. In general, the annual dose limits and corresponding constraints for public exposure should apply.

(20) Member States should be required to submit certain practices involving a hazard from ionising radiation to a system of regulatory control or to prohibit certain practices. Member States should benefit from the application of a graded approach to regulatory control, which should be commensurate with the magnitude and likelihood of exposures resulting from the practices, and commensurate with the impact that regulatory control may have in reducing such exposures or improving the safety of installations.

(21) There is benefit in having the same activity concentration values both for the exemption of practices from regulatory control and for the clearance of materials from regulated practices. After a comprehensive review, it has been concluded that the values recommended in IAEA document RS-G-1.7[17] can be used both as default exemption values, replacing the activity concentration values laid down in Annex I to Directive 96/29/Euratom, and as general clearance levels, replacing the values recommended by the Commission in Radiation Protection No 122[18].

(22) Member States may grant specific exemption from authorisation for certain practices involving activities above the exemption values.

(23) Specific clearance levels, above the default values for exemption and clearance, as well as corresponding Community guidance[19] remain important tools for the management of large volumes of materials arising from the dismantling of licensed facilities.

(24) Member States should ensure that outside workers receive the same protection as exposed workers employed by undertakings performing practices with radiation sources. The specific arrangements for outside workers in Directive 90/641/Euratom should be extended to cover work in supervised areas as well.

(25) With regard to the management of emergency exposure situations, the current approach based on intervention levels should be replaced by a more comprehensive system comprising threat analysis, an overall emergency management system, emergency response plans for identified threats, and pre-planned strategies for the management of each postulated event.

(26) The introduction of reference levels in emergency and existing exposure situations allows for the protection of the individual as well as consideration of other societal criteria in the same way as dose limits and dose constraints for planned exposure situations.

(27) The efficient management of a nuclear emergency with cross-border consequences calls for enhanced cooperation between Member States in emergency planning and response.

(28) The International Atomic Energy Agency together with the World Health Organisation, the Food and Agricultural Organisation, the International Labour Organisation, the Nuclear Energy Agency of the Organisation for Economic Cooperation and Development, and the Pan-American Health Organisation are revising the International Basic Safety Standards in the light of the ICRP’s new Publication 103.

(29) The roles and responsibilities of the national services and experts involved in ensuring that the technical and practical aspects of radiation protection are managed with a high level of competence need to be clarified.

(30) More precise requirements should be introduced for the issuing discharge authorisations and for the monitoring of discharges. Commission Recommendation 2004/2/Euratom of 18 December 2003 on standardised information on radioactive airborne and liquid discharges into the environment from nuclear power reactors and reprocessing plants in normal operation[20] introduced standardised information for the reporting of data on discharges from nuclear power plants and reprocessing facilities.

(31) No major changes need to be made to the most recent Directive 2003/122/Euratom on the control of high-activity sealed radioactive sources and orphan sources, except to broaden some of the requirements to include any sealed radioactive source. However, there are still unresolved problems with orphan sources and there have been significant cases of contaminated metal being imported from third countries. Accordingly, a requirement should be introduced for the notification of incidents with orphan sources or the contamination of metal. With regard to international security, it is also important to harmonise the levels above which a source is regarded as a high-activity sealed source with those established by the IAEA.

(32) 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 legislator considers the transmission of such documents to be justified.

(33) Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom should therefore be repealed,

HAS ADOPTED THIS DIRECTIVE:

CHAPTER I

SUBJECT MATTER AND SCOPE

Article 1

Subject matter

1. This Directive establishes the basic safety standards for the protection of the health of workers, general public, patients and other individuals subject to medical exposure against the dangers arising from ionising radiation for the purpose of their uniform implementation by Member States.

2. This Directive applies to the protection of the environment as a pathway from radiation sources to the exposure of man, complemented where appropriate with specific consideration of the exposure of biota in the environment as a whole.

3. This Directive sets out requirements for the control of the safety and security of radioactive sources and the provisions of appropriate information in an emergency exposure situation.

4. This Directive sets out requirements for the prevention of exposure of workers and members of the public to ionising radiation arising from orphan sources and from inadequate control of high-activity sealed radioactive sources and for the harmonisation of controls in place in the Member States by defining specific requirements ensuring that each such source is kept under control.

5. This Directive defines at Community level common objectives with regard to measures and procedures for informing the public for the purpose of improving the operational health protection provided in the event of an emergency.

Article 2

Scope

1. This Directive applies to any planned, existing or emergency exposure situation which involves a risk from exposure to ionising radiation which cannot be disregarded from the radiation protection point of view with regard to the health protection of workers, members of the public, or patients and other individuals subject to medical exposure or with regard to the protection of the environment.

2. This Directive applies to all practices involving radiation sources, namely:

(a) the production, processing, handling, use, storage, holding, transport, shipment, import to, and export from the Community and the disposal of radioactive material;

(b) the operation of electrical equipment emitting ionising radiation and the operation of any electrical equipment operating at a potential difference of more than 5 kV;

(c) practices which involve the presence of natural radiation sources that lead to a significant increase in the exposure of workers or members of the public, in particular:

i) the operation of aircraft and spacecraft;

ii) exposure to radon in workplaces;

iii) the activities in industries processing materials with naturally occurring radionuclides, or activities related to such processing.

(d) any other practice specified by the Member State.

3. This Directive applies to the management of existing exposure situations, in particular the exposure of the public to indoor radon, the external exposure from building materials and cases of lasting exposure resulting from the after-effects of an emergency or a past activity.

4. This Directive applies to the management of emergency exposure situations to the extent that these are deemed to warrant intervention to protect the health of the public or workers or to protect the environment; potential exposures as well as emergency preparedness and planning are part of planned exposure situations.

Article 3

Exclusion from the scope

This Directive shall not apply to radionuclides naturally contained in the human body, to cosmic radiation prevailing at ground level, and to aboveground exposure to radionuclides present in the undisturbed earth’s crust.

CHAPTER II

DEFINITIONS

Article 4

For the purpose of this Directive, the following definitions shall apply:

(1) Medical exposure means exposure incurred by patients or asymptomatic individuals as part of their own medical or dental diagnosis or treatment, and intended to benefit their health or well-being, as well as exposure incurred by carers and comforters and by volunteers in biomedical research;

(2) Ionising radiation means the transfer of energy in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or less (a frequency of 3x1015 Hertz or more) capable of producing ions directly or indirectly;

(3) Emergency means a non-routine situation or event that necessitates prompt action primarily to mitigate a hazard or adverse consequences for human health and safety, quality of life, property or the environment. This includes nuclear and radiological emergencies;

(4) Emergency exposure situation means a situation of exposure due to any sudden event which requires urgent decisions to be taken in order to control this situation; the event may result from an accident (whether or not envisaged as a potential exposure) or from a malicious act;

(5) Exposure means the act of exposing or condition of being exposed to ionising radiation emitted outside the body (external exposure) or within the body (internal exposure);

(6) Exposure situation means a situation giving rise to exposure, including the radiation sources and the activities or actions which may affect the exposure from these radiation sources;

(7) Members of the public mean individuals, subject to public exposure;

(8) Radiation source means an entity that may cause radiation exposure — such as by emitting ionising radiation or by releasing radioactive material — and can be treated as a single entity for protection and safety purposes;

(9) Radioactive source means a radiation source incorporating radioactive material for the purpose of utilising its radioactivity;

(10) Radioactive material means material incorporating radioactive substances;

(11) Orphan source means a sealed source which is neither exempted nor under regulatory control, e.g. because it has never been under regulatory control or because it has been abandoned, lost, misplaced, stolen or otherwise transferred without proper authorisation;

(12) Building material means a construction product which is produced for incorporation in a permanent manner in a building;

(13) Disposal means the emplacement of radioactive waste or spent fuel in an authorised facility without the intention of retrieval;

(14) Existing exposure situation means an exposure situation that already exists when a decision on its control has to be taken and which does not call or no longer calls for urgent measures to be taken;

(15) Natural radiation source means sources of ionising radiation of natural terrestrial or cosmic origin;

(16) Planned exposure situation means an exposure situation that arises from the planned operation or introduction of a radiation source or from activities which alter exposure pathways, so as to cause the exposure or potential exposure of people or the environment. Planned exposure situations may include both normal exposures and potential exposures;

(17) Potential exposure means exposure that is not expected with certainty but may result from an event or sequence of events of a probabilistic nature, including equipment failures and operating errors.

(18) Radiation protection means the protection of people from harmful effects of exposure to ionising radiation, and the means for achieving this;

(19) Practice means any activity that involves the operation or introduction of radiation sources or which alters exposure pathways and is managed as a planned exposure situation;

(20) Radon means the isotope Rn-222 and its progeny, as appropriate (exposure to radon means exposure to radon progeny);

(21) Storage means the holding of radioactive sources or radioactive waste in a facility that provides adequate containment, with the intention of retrieval;

(22) Optimisation means a forward-looking iterative process to establish adequate protection measures taking into account the prevailing circumstances, the available options, and the nature of the exposure situation, with the aim of keeping the magnitude and likelihood of exposure and the number of people exposed as low as reasonably achievable;

(23) Public exposure means exposure of individuals, excluding any occupational or medical exposure;

(24) Occupational exposure means exposure of workers incurred in the course of their work;

(25) Health detriment means an estimate of the risk of reduction in length and quality of life occurring in a population following exposure. This includes loss arising from tissue effects, cancer and severe genetic disorder;

(26) Effective dose (E) means the sum of the weighted equivalent doses in all the tissues and organs of the body from internal and external irradiation. It is defined by the expression:

where

DT,R is the absorbed dose averaged over tissue or organ T, due to radiation R,

wR is the radiation weighting factor and

wT is the tissue weighting factor for tissue or organ T.

The appropriate wT and wR values are specified in Publication 103 of the International Commission on Radiological Protection. The unit for effective dose is the sievert;

(27) Dose limit means the value of the effective dose or the equivalent dose in a specified period which may not be exceeded for an individual. The dose limit applies to the sum of exposures from all authorised practices;

(28) Dose constraint means a constraint set as a prospective upper bound of an individual dose, used to define the range of options considered in the process of optimisation for a given radiation source in a planned exposure situation;

(29) Equivalent dose (HT) means the absorbed dose, in tissue or organ T weighted for the type and quality of radiation R. It is given by:

where

– DT,R is the absorbed dose averaged over tissue or organ T, due to radiation R,

– wR is the radiation weighting factor.

When the radiation field is composed of types and energies with different values of wR, the total equivalent dose, HT, is given by:

The appropriate wR values are specified in Publication 103 of the International Commission on Radiological Protection. The unit for equivalent dose is the sievert.

(30) Outside worker means any exposed worker of category A who is not employed by the undertaking responsible for the supervised and controlled areas, but performs activities in these areas, including trainees, apprentices and students;

(31) Undertaking means a natural or legal person who has legal responsibility for carrying out a practice or who has legal responsibility for a radiation source (including cases where the owner or holder of a radiation source does not conduct related activities);

(32) Risk constraint means a constraint set as a restriction on the individual risk from a radiation source (risk in the sense of probability of health detriment due to a potential exposure, which is a function of the probability of an unintended event causing a dose and the probability of detriment due to that dose);

(33) Carers and comforters means individuals knowingly and willingly incurring an exposure to ionising radiation by helping, other than as part of their occupation, in the support and comfort of individuals undergoing or having undergone medical exposure;

(34) Reference level means, in an emergency exposure situation or in an existing exposure situation, the level of dose or risk above which it is judged inappropriate to allow exposures to occur, and below which optimisation of protection should continue to be implemented;

(35) Exposed worker means a person, either self-employed or working under an employer, who is subject to exposure at work carried out within a practice regulated by this Directive and who is liable to receive doses exceeding one or other of the dose limits for public exposure;

(36) Sievert (Sv) means the special name of the unit of equivalent or effective dose. One sievert is equivalent to one joule per kilogram: 1 Sv = 1 J kg-1;

(37) Intake means the activities of radionuclides entering the body from the external environment;

(38) Apprentice means a person receiving training or instruction within an undertaking with a view to exercising a specific skill.

(39) Committed effective dose (E(t)) means the sum of the committed organ or tissue equivalent doses HT(t) resulting from an intake, each multiplied by the appropriate tissue weighting factor wT. It is defined by:

In specifying E(t),t is given in the number of years over which the integration is made. For the purpose of complying with dose limits specified in this Directive, t is a period of 50 years following intake for adults and up to age 70 for children. The unit for committed effective dose is the sievert;

(40) Medical physics expert means an individual having the knowledge, training and experience to act or give advice on matters relating to radiation physics applied to medical exposure, whose competence to act is recognised by the competent authorities;

(41) Occupational health service means a health professional or body having competence for the medical surveillance of exposed workers and whose capacity to act in that respect is recognised by the competent authorities;

(42) Radiation protection expert means an individual having the knowledge, training and experience needed to give radiation protection advice in order to ensure the effective protection of individuals, and whose capacity to act is recognised by the competent authorities;

(43) High-activity sealed source means a sealed source in which the amount of radioactive material exceeds the values laid down in Annex II;

(44) Emergency response plan means arrangements to plan for adequate response in the event of an emergency exposure situation related to a specific facility or activity on the basis of postulated events and related scenarios;

(45) Emergency worker means any person having a defined role as a worker in an emergency and who might be exposed while taking action in response to the emergency;

(46) Dosimetry service means a body or an individual having the competence for calibration, reading or interpretation of individual monitoring devices, or for measurement of radioactivity in the human body or in biological samples, or for assessment of doses, whose capacity to act in this respect is recognised by the competent authorities;

(47) Emergency management system means legal or administrative framework establishing responsibilities for emergency preparedness and response, and arrangements for decision making in the event of an emergency exposure situation;

(48) Medical radiological means pertaining to radiodiagnostic and radiotherapeutic procedures, and interventional radiology or other planning and guiding radiology using ionising radiation;

(49) Practical aspects of medical exposure procedures means the physical conduct of a medical exposure and any supporting aspects including handling and use of medical radiological equipment, and the assessment of technical and physical parameters, including radiation doses, calibration and maintenance of equipment, preparation and administration of radio-pharmaceuticals, and image processing as carried out by, among others, radiographers and technicians in nuclear medicine and radiotherapy;

(50) Practitioner means a medical doctor, dentist or other health professional who is entitled to take clinical responsibility for an individual medical exposure in accordance with national requirements.

(51) Diagnostic reference levels means dose levels in medical radiodiagnostic or interventional radiology practices, or, in the case of radio-pharmaceuticals, levels of activity, for typical examinations for groups of standard-sized patients or standard phantoms for broadly defined types of equipment;

(52) Activation means the process through which a stable nuclide is transformed into a radionuclide by irradiating with particles or high-energy photons the material in which it is contained;

(53) Radioactive substance means any substance that contains one or more radionuclides, the activity concentration of which cannot be disregarded as far as radiation protection is concerned;

(54) Non-medical imaging exposure means any deliberate exposure of humans for imaging purposes where the primary motivation for the exposure is not related to the health or well-being of the individual being exposed;

(55) Notification means submission of a document to the competent authority to notify the intention to carry out a practice within the scope of this Directive.

(56) Registration means permission granted in a document by the competent authority, or granted by national legislation, to carry out an activity in accordance with conditions laid down in national legislation;

(57) Consumer product means a device or manufactured item into which radionuclides have deliberately been incorporated or produced by activation, or which generates ionising radiation, and which can be sold or made available to members of the public without special surveillance or regulatory control after sale;

(58) Accelerator means an apparatus or installation in which particles are accelerated, emitting ionising radiation with energy higher than 1 mega-electron volt (MeV);

(59) Disused sealed source means a sealed source which is no longer used or intended to be used for the practice for which authorisation was granted;

(60) Inspection means an investigation by any competent authority to verify compliance with national provisions;

(61) Radiation generator means a device capable of generating ionising radiation, such as X rays, neutrons, electrons or other charged particles, which may be used for scientific, industrial or medical purposes;

(62) Radioactive waste means radioactive material for which no further use is foreseen.

(63) Quality assurance means all those planned and systematic actions necessary to provide adequate assurance that a structure, system, component or procedure will perform satisfactorily in compliance with agreed standards. Quality control is a part of quality assurance;

(64) Licence means permission granted by the competent authority, on application, to carry out a practice subject to conditions laid down in a specific licence document;

(65) Clearance levels means values established by the competent authority or in national legislation, and expressed in terms of activity concentrations, at or below which materials arising from any practice subject to notification or authorisation may be released from the requirements of this Directive.

(66) Supervised area means an area subject to supervision for the purpose of protection against ionising radiation;

(67) Controlled area means an area subject to special rules for the purpose of protection against ionising radiation or preventing the spread of radioactive contamination and to which access is controlled;

(68) Accidental exposure means an exposure of individuals, other than emergency workers, as a result of an accident;

(69) Emergency occupational exposure means occupational exposure received in an emergency exposure situation by individuals taking action to mitigate the consequences of the emergency;

(70) Health screening means a procedure using medical radiological installations for early diagnosis in population groups at risk;

(71) Radon-prone area means a geographic area or administrative region defined on the basis of surveys indicating that the percentage of dwellings expected to exceed the national reference level is significantly higher than in other parts of the country;

(72) Medical radiological procedure means any procedure giving rise to medical exposure;

(73) Referrer means a medical doctor, dentist or other health professional who is entitled to refer individuals for medical radiological procedures to a practitioner, in accordance with national requirements;

(74) Individual detriment means clinically observable deleterious effects in individuals or their descendants, the appearance of which is either immediate or delayed and, in the latter case, implies a probability rather than a certainty of appearance;

(75) Interventional radiology means the use of X-ray imaging techniques, in addition to those involving ultrasound or magnetic resonance imaging or other non-ionising radiation techniques, to introduce and guide devices in the body for diagnostic or treatment purposes;

(76) Radiodiagnostic means pertaining to in-vivo diagnostic nuclear medicine, medical diagnostic radiology using ionising radiation, and dental radiology;

(77) Radiotherapeutic means pertaining to radiotherapy, including nuclear medicine for therapeutic purposes;

(78) Clinical responsibility means responsibility of a practitioner for individual medical exposures, notably: justification; optimisation; clinical evaluation of the outcome; cooperation with other specialists and staff, as appropriate, regarding practical aspects of medical exposure procedures; obtaining information, if appropriate, on previous examinations; providing existing medical radiological information and/or records to other practitioners and/or the referrer, as required; and giving information on the risk of ionising radiation to patients and other individuals involved, as appropriate;

(79) Clinical audit means a systematic examination or review of medical radiological procedures which seeks to improve the quality and outcome of patient care through structured review, whereby medical radiological practices, procedures and results are examined against agreed standards for good medical radiological procedures, with modification of practices where indicated and the application of new standards if necessary;

(80) Medical radiological installation means a facility containing medical radiological equipment;

(81) Unintended exposure means medical exposure that is significantly different from the medical exposure intended for a given purpose;

(82) Representative person means an individual receiving a dose that is representative of the more highly exposed individuals in the population;

(83) Radiation protection officer means an individual who is technically competent in radiation protection matters relevant for a given type of practice and is designated by the undertaking to oversee the implementation of the radiation protection arrangements of the undertaking;

(84) Remedial measures means the removal of a source or the reduction of its magnitude (in terms of activity or amount) for the purposes of avoiding or reducing doses that might otherwise be received in an existing exposure situation.

(85) Protective measures means measures, other than remedial measures, for the purpose of avoiding or reducing doses that might otherwise be received in an emergency exposure situation or an existing exposure situation.

(86) Authorisation means the granting by a competent authority of written permission for an undertaking to perform specified activities subject to regulatory control in the form of registration or a licence;

(87) Sealed source means a radioactive source in which the radioactive material is permanently sealed in a capsule or closely bonded in a solid form;

(88) Supplier means any natural or legal person who supplies or makes available a sealed source;

(89) Source container means the containment of a sealed source, where this is not an integral part of the source but is meant for shielding the source during its use, transport, handling, etc.

(90) Thoron means the isotope Rn-220;

(91) Residual dose means the dose expected to be incurred from all exposure pathways after protective measures have been fully implemented, or where a decision has been taken not to implement any protective measures;

(92) Absorbed dose (D) means the energy absorbed per unit mass

where

– is the mean energy imparted by ionising radiation to the matter in a volume element,

– dm is the mass of the matter in this volume element.

In this Directive, absorbed dose denotes the dose averaged over a tissue or an organ. The unit for absorbed dose is the gray.

(93) Gray (Gy) is the unit of absorbed dose. One gray is equal to one joule per kilogram: 1Gy = 1 J kg-1;

(94) Activity (A) means the activity, A, of an amount of a radionuclide in a particular energy state at a given time. It is the quotient of dN by dt, where dN is the expectation value of the number of spontaneous nuclear transitions from that energy state in the time interval dt:

The unit of activity is the becquerel;

(95) Becquerel (Bq) means the special name of the unit of activity. One becquerel is equivalent to one nuclear transition per second: 1 Bq = 1 s-1;

(96) Committed equivalent dose (H(t)) means the integral over time (t) of the equivalent dose rate (in tissue or organ T) that will be received by an individual as a result of an intake. It is given by:

for an intake at time t0 where

is the relevant equivalent dose rate (in organ or tissue T) at time t,

t is the time over which the integration is performed.

In specifying HT(t), t is given in years. When t is not given, a period of 50 years is assumed for adults and up to age 70 for children. The unit for committed equivalent dose is the sievert;

(97) Normal exposure means exposure expected to occur under the normal operating conditions of a facility or activity (including maintenance, inspection, decommissioning), including possible minor mishaps that can be kept under control, i.e. during normal operation and anticipated operational occurrences;

(98) Projected dose means the dose that would be expected to be incurred if no protective measures were to be taken;

(99) Quality control means the set of operations (programming, coordinating, implementing) intended to maintain or to improve quality. It includes monitoring, evaluation and maintenance at required levels of all characteristics of performance of equipment that can be defined, measured, and controlled;

(100) Response strategy means a set of different protective measures to respond to postulated or actual events so as to manage an emergency exposure situation in accordance with the stated objectives. Within an emergency response plan, response strategies are established for each postulated event and scenario;

CHAPTER III

SYSTEM OF RADIATION PROTECTION

Article 5

General principles

Member States shall establish legal requirements and an appropriate regime of regulatory control which, for all exposure situations reflect a system of radiation protection based on the following principles of justification, optimisation and dose limitation:

(a) justification: decisions introducing or altering a radiation source, an exposure pathway or actual exposures shall be justified in the sense that such decisions shall be taken with the intent to ensure that the individual or societal benefit resulting from them offsets the detriment that they may cause;

(b) optimisation: in all exposure situations, radiation protection shall be optimised with the aim of keeping the magnitude and likelihood of exposure and the number of individuals exposed as low as reasonably achievable, taking into account economic and societal factors, whereby optimisation of the protection of individuals undergoing medical exposure shall be commensurate with the medical purpose of the exposure as described in Article 55. This principle shall be applied in terms of effective dose as well as organ doses, as a precautionary measure to allow for uncertainties as to health detriment below the threshold, for deterministic effects;

(c) dose limitation: in planned exposure situations, the sum of doses to an individual from all regulated radiation sources may not exceed the dose limits laid down for occupational exposure or public exposure. Dose limits shall not apply to medical exposures.

Section 1

tools for optimisation

Article 6

Dose constraints for occupational and public exposure

1. For occupational exposure, the dose constraint shall be established as an operational tool for optimisation by the undertaking under the general supervision of the competent authorities. In the case of outside workers the dose constraint shall be established in cooperation between the employer and the undertaking.

2. For public exposure, the dose constraint shall be set for the individual dose that members of the public receive from the planned operation of a specified radiation source. The competent authorities shall set the constraint so as to ensure compliance with the dose limit for the sum of doses to the same individual from all authorised practices.

3. With regard to potential exposures, optimisation shall include adequate management of the safety and security of sources and facilities. Where appropriate risk constraints may be established.

4. Dose constraints shall be established in terms of individual effective or equivalent doses over a year or any other appropriate shorter time period.

5. Where dose constraints are introduced to restrict any protracted accumulated exposure, these shall be established in terms of annual effective doses or equivalent doses to an organ.

Article 7

Dose constraints for medical exposure

Dose constraints shall not apply for the medical exposure of patients.

For carers and comforters and for volunteers participating in medical and biomedical research (for whom no direct medical benefit is expected from the exposure), dose constraints shall be established in terms of the individual dose that is unlikely to be exceeded for the period of the examination, treatment or research project in question.

Article 8

Reference levels

1. Reference levels shall be established for emergency and existing exposure situations as a level of effective dose or organ dose above which it is judged inappropriate to allow exposures in emergency or existing exposure situations.

2. Optimised protective strategies shall be planned and implemented with the objective of reducing individual doses below the reference levels. The values chosen for reference levels shall depend upon the type of exposure situation.

3. Optimisation of protection shall give priority to exposures above the reference level. The choices of reference levels shall take into account both radiological protection requirements and societal criteria.

4. The choice of reference levels for the effective dose shall take into account the three bands of reference levels set out in point 1 of Annex I.

Section 2

Dose limitation

Article 9

Age limit for exposed workers

Subject to Article 12(2), persons under 18 years of age may not be assigned to any work which would result in their being exposed workers.

Article 10

Dose limits for occupational exposure

1. The limit on the effective dose for occupational exposure shall be 20 mSv in any single year. However, in special circumstances or for certain exposure situations specified in national legislation, a higher effective dose of up to 50 mSv per year may be authorised in a single year, provided that the average dose over any five consecutive years does not exceed 20 mSv per year.

For emergency workers a higher effective dose may be authorised, in accordance with Article 52.

2. In addition to limits of effective dose laid down in paragraph 1, the following limits on equivalent dose shall apply:

(a) the limit on the equivalent dose for the lens of the eye shall be 20 mSv in a year or, where applicable, the same value as specified for the limit on effective dose;

(b) the limit on the equivalent dose for the skin shall be 500 mSv in a year; this limit shall apply to the dose averaged over any area of 1 cm², regardless of the area exposed;

(c) the limit on the equivalent dose for the hands, forearms, feet and ankles shall be 500 mSv in a year.

Article 11

Protection of pregnant women

1. As soon as a pregnant woman informs the undertaking of her condition, in accordance with national legislation or national practice, the protection of the unborn child shall be comparable with that provided for members of the public. The employment conditions for the pregnant woman shall be such that the equivalent dose to the unborn child is as low as reasonably achievable and unlikely to exceed 1 mSv during at least the remainder of the pregnancy.

2. As soon as a breastfeeding woman informs the undertaking of her condition, she shall not be employed in work involving a significant risk of intake of radionuclides.

Article 12

Dose limits for apprentices and students

1. The dose limits for apprentices aged 18 years or over and students aged 18 years or over who, in the course of their studies, are obliged to work with radiation sources shall be the same as the dose limits for occupational exposure laid down in Article 10.

2. The limit on the effective dose for apprentices aged between 16 and 18 years and for students aged between 16 and 18 years who, in the course of their studies, are obliged to work with radiation sources shall be 6 mSv per year.

In addition to limits of effective dose laid down in the first subparagraph, the following limits on equivalent dose shall apply:

(a) the limit on the equivalent dose for the lens of the eye shall be 20 mSv in a year;

(b) the limit on the equivalent dose for the skin shall be 150 mSv in a year, averaged over any area of 1 cm², regardless of the area exposed;

(c) the limit on the equivalent dose for the hands, forearms, feet and ankles shall be 150 mSv in a year.

3. The dose limits for apprentices and students who are not subject to paragraphs 1 and 2 shall be the same as the dose limits for members of the public as specified in Article 13.

Article 13

Dose limits for public exposure

1. The limit on the effective dose for public exposure shall be 1 mSv in a year.

2. In addition to the dose limit referred to in the paragraph 1, the following limits on the equivalent dose shall apply:

(a) the limit on the equivalent dose for the lens of the eye shall be 15 mSv in a year;

(b) the limit on the equivalent dose for the skin shall be 50 mSv in a year, averaged over any 1 cm² area of skin, regardless of the area exposed.

Article 14

Estimation of the effective and equivalent dose

For the estimation of effective and equivalent doses, the following values and relationships shall be used:

(a) for external radiation, the values and relationships laid down in Publication 103 of the International Commission on Radiological Protection shall be used to estimate the effective and equivalent doses;

(b) for internal exposure from a radionuclide or from a mixture of radionuclides, the values and relationships laid down in Publication 103 of the International Commission on Radiological Protection and the ingestion and inhalation dose coefficients laid down in Publication 72 of the International Commission on Radiological Protection shall be used to estimate the committed effective doses.

CHAPTER IV

REQUIREMENTS FOR RADIATION PROTECTION EDUCATION, TRAINING AND INFORMATION

Article 15

General responsibilities for education, training and provision of information

1. Member States shall establish an adequate legislative and administrative framework for providing appropriate radiation protection education, training and information to all individuals whose tasks require specific competences in radiation protection. The training, retraining and information of relevant individuals shall be repeated at appropriate intervals and documented.

2. Member States shall establish education, training and retraining to allow the recognition of radiation protection experts, medical physics experts, occupational health services, and dosimetry services.

Article 16

Training of exposed workers, apprentices and students and information provided to them

1. Member States shall require the undertaking or the employer to inform exposed workers, apprentices and students who are subject to occupational exposure on:

(a) the health risks involved in their work;

(b) the general radiation protection procedures and precautions to be taken, in particular those connected with the operational and working conditions of both the practice in general and each type of workstation or work to which they may be assigned;

(c) the emergency response plans and procedures;

(d) the importance of complying with the technical, medical and administrative requirements;

2. Member States shall require the undertaking or the employer to inform women on the importance of making an early declaration of pregnancy in view of the risks of exposure for the unborn child and the risk of contaminating a nursing infant after intake of radionuclides.

3. Member States shall require that the undertaking or the employer provides appropriate radiation protection training and information programmes for their personnel.

4. In addition to the information and training in the field of radiation protection as provided for in paragraphs 1, 2 and 3, an undertaking responsible for high-activity sealed sources shall ensure that such training includes specific requirements for the safe management and security of high-activity sealed sources with a view to preparing the relevant workers adequately for any events affecting their own safety or the radiation protection of other individuals. The information and training shall place particular emphasis on the necessary safety requirements and shall contain specific information on the possible consequences of the loss of adequate control of high-activity sealed sources.

Article 17

Information and training of workers potentially exposed to orphan sources

Member States shall ensure that the management of and workers in installations where orphan sources are most likely to be found or processed, in particular large metal scrap yards and major metal scrap recycling plants, and in significant nodal transit points, are:

(a) informed of the possibility that they may be confronted with a source;

(b) advised and trained in the visual detection of sources and their containers;

(c) informed of basic facts about ionising radiation and its effects;

(d) informed about detection systems;

(e) informed of and trained in the action to be taken on site in the event of the detection or suspected detection of a source.

Article 18

Information and training for emergency workers

1. Member States shall ensure that emergency workers and any other persons who might be involved in the organisation of emergency assistance in the event of an emergency are given adequate and regularly updated information on the health risks their intervention might involve and on the precautionary measures to be taken in such an event. This information shall take into account the range of potential emergencies.

2. As soon as an emergency occurs, the information referred to in paragraph 1 shall be supplemented appropriately, having regard to the specific circumstances.

3. Member States shall ensure that emergency workers receive regular training as provided for in the emergency management system set out in Article 97. Where appropriate, this training shall include practical exercises.

4. Members States shall ensure that, in addition to the emergency response training referred to in paragraph 3 of this Article, the organisation responsible for the protection of emergency workers as referred to in Article 30(1)(b) provides these workers with appropriate radiation protection training and information.

Article 19

Education, information and training in the field of medical exposure

1. Member States shall ensure that practitioners and the individuals involved in the practical aspects of medical exposure procedures have adequate education, information and theoretical and practical training for the purpose of medical radiological practices, as well as relevant competence in radiation protection.

For this purpose Member States shall ensure that appropriate curriculum are established and shall recognise the corresponding diplomas, certificates or formal qualifications.

2. Individuals undergoing relevant training programmes may participate in practical aspects of medical exposure procedures as set out in Article 56(4).

3. Member States shall ensure that continuing education and training after qualification is provided and, in the special case of the clinical use of new techniques, training is provided on these techniques and the relevant radiation protection requirements.

4. Member States shall ensure that mechanisms are in place for the timely dissemination of information relevant to radiation protection for medical exposure regarding lessons learned from significant events.

5. Member States shall ensure the introduction of a course on radiation protection in the basic curriculum of medical and dental schools.

CHAPTER V

JUSTIFICATION AND REGULATORY CONTROL OF PRACTICES

Article 20

Justification of practices

1. Member States shall ensure that new types of practices resulting in exposure to ionising radiation are justified before being approved.

2. Member States shall list the approved types of practices in legislation or administrative acts.

3. Existing types of practices shall be reviewed as to their justification whenever new and important evidence about their efficacy or potential consequences is acquired.

Article 21

Justification of practices with apparatus or products emitting ionising radiation

1. Member States shall require any undertaking intending to manufacture or import or export a new type of apparatus or product emitting ionising radiation to provide the competent authorities with relevant information as set out in Annex III, Section A, in order to enable the authorities, on the basis of assessment of information set out in Annex III, Section B, to decide whether the intended use of the apparatus or product can be justified.

2. The competent authority shall share the information received in accordance with paragraph 1 with the competent authorities of the other Member States to allow them to take their own decision on the justification of the intended use of the apparatus or product.

3. The undertaking shall be informed on the decisions of the Member States' competent authorities within a period of six months.

Article 22

Prohibition of practices

Member States shall prohibit the deliberate addition of radioactive substances in the production of foodstuffs, toys, personal ornaments and cosmetics, and shall prohibit the import or export of such products. Without prejudice to Directive 1999/2/EC of the European Parliament and of the Council[21], practices involving the activation of material resulting in an increase in activity in the associated products shall be deemed not to be justified.

Article 23

Practices involving the deliberate exposure of humans for non-medical purposes

1. Member States shall ensure the identification, by means of surveys or by any other appropriate means, of practices involving non-medical imaging exposure, as set out in Annex IV.

2. Member States shall ensure that special attention is given to the justification of practices involving non-medical imaging exposure, in particular:

(a) all types of practices involving non-medical imaging exposure, as listed in Annex IV, shall be justified in advance before being generally accepted;

(b) each particular application of a generally accepted type of practice shall be justified in advance;

(c) all individual non-medical imaging exposure procedures as listed in Annex IV, section A implemented by medical staff using medical radiological equipment shall be justified in advance taking into account the specific objectives of the procedure and the characteristics of the individual involved;

(d) the general and particular justification of practices involving non-medical imaging exposure, as specified in points (a) and (b), shall be subject to periodic review by the competent authority.

3. Where a Member State has determined that a particular practice involving non-medical imaging exposure is justified it shall ensure that:

(a) each practice is subject to authorisation;

(b) requirements for the practice, including criteria for individual implementation, are established by the competent authority, in cooperation with other relevant agencies and professional bodies as appropriate;

(c) dose constraints are established for each practice. Such shall be well below the dose limit for members of the public, including, whenever practicable, for procedures implemented by medical staff using medical equipment as set out in Annex IV, Section A; for other practices set out in Annex IV, section B, the dose constraint shall satisfy the requirements of Article 6(2);

(d) relevant requirements set out in Chapter VII, including those for equipment, optimisation, responsibilities and special protection during pregnancy, are met for procedures implemented by medical staff using medical radiological equipment;

(e) the informed consent of the individual to be exposed is sought, allowing for cases where the law enforcement bodies may proceed without consent according to national legislation;

(f) where the exposure is routinely carried out for security purposes the screened individuals are provided with a choice of an alternative technique which does not involve exposure to ionising radiation.

Article 24

Identification of practices involving naturally occurring radioactive material

Member States shall ensure the identification of practices involving naturally occurring radioactive material and leading to exposure of workers or members of the public which cannot be disregarded from a radiation protection point of view. Such identification shall be carried out by means of surveys or by any other appropriate means taking into account industrial sectors listed in Annex V.

Article 25

Notification

1. Member States shall require all practices, including practices identified in accordance with Article 24, to be notified, except for justified practices involving the following:

(a) materials containing radioactive substances where the quantities of the activity involved do not exceed in total the exemption values set out in Annex VI or higher values that, for specific applications, are authorised by the competent authorities and satisfy the general exemption and clearance criteria set out in Annex VI; or

(b) materials containing radioactive substances, provided that the concentrations of activity per unit mass do not exceed the exemption values set out in Table A of Annex VI, or higher values that, for specific applications, are authorised by the competent authorities and satisfy the general exemption and clearance criteria set out in Annex VI; or

(c) any cathode ray tube intended for the display of visual images, or other electrical apparatus operating at a potential difference not exceeding 30 kV, or any other apparatus or product which is of a type approved by the competent authorities of the Member State, provided that:

(i) it does not cause, in normal operating conditions, a dose rate exceeding 1 µSv×h–1 at a distance of 0.1 m from any accessible surface of the apparatus; and

(ii) if it contains radioactive substances, these substances are embedded in a capsule or fixed to a solid holder; and

(iii) conditions for disposal have been specified by the competent authorities.

2. Member States may exempt further types of practices from the notification requirement subject to compliance with the general exemption criteria established in point 3 of Annex VI, or in such cases where an assessment of the optimisation of protection shows that exemption is the best option.

3. Practices that involve naturally occurring radioactive material, identified in accordance with Article 24, and produce or process residues which are known to be recycled into identified building materials are subject to notification if the activity concentration index as defined in Annex VII in the resulting building materials is liable to exceed 1. The undertaking shall also in this case inform the user of the residue about the activity concentration of the residue.

4. In situations identified by Member States where there is concern that a practice identified in accordance with Article 24 may lead to the presence of naturally occurring radionuclides in water liable to affect the quality of drinking water supplies or affect any other exposure pathways, so as to be of concern from a radiation protection point of view, the competent authority may require that the practice be subject to notification irrespective of paragraph 1(b) of this Article.

5. For types of practices subject to notification, Member States shall specify the information to be provided by the undertaking so as to allow the competent authority to establish appropriate means of regulatory control.

6. For the purpose of exemption in accordance with paragraph 1(c), Member States shall exchange information on the type approvals that have been granted and on the underlying documentation and assessment. Competent authorities shall take into account such information received, as well as applicable European and international standards, in making their own decisions with regard to the exemption of corresponding practices.

Article 26

Regulatory control

1. Member States shall require any notified practice to be subject to regulatory control commensurate with the magnitude and likelihood of exposures resulting from the practice, and commensurate with the impact that regulatory control may have in reducing such exposures or improving the safety of installations.

2. Notified practices may be exempted from authorisation.

3. In the case of moderate amounts of material as specified by Member States, the activity concentration values laid down in Annex VI, Table B, column 2, may be used for the purpose of exemption.

4. Notified practices which are not exempted shall be subject