# EUR-Lex - 52012PC0242 - EN

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# 52012PC0242

**Proposal for a COUNCIL DIRECTIVE laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation /* COM/2012/0242 final - 2011/0254 (NLE) */**

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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 to authorisation through registration or
licensing.

Article 27

Authorisation

1.           In cases where a limited
risk of exposure does not necessitate the examination of individual cases and
the practice is undertaken in accordance with conditions laid down in national
legislation, competent authorities may limit regulatory control to registration
of the practice and an appropriate frequency of inspections.

2.           Member States shall
require licensing for the following practices:

(a)
the operation and decommissioning of any
facility of the nuclear fuel cycle and the exploitation and closure of uranium
mining;

(b)
the deliberate addition of radioactive
substances in the production and manufacture of consumer products or other
products, including medicinal products, and the import or export of such
products;

(c)
the manufacture, use or taking possession of a
high-activity sealed source;

(d)
the operation, decommissioning and closure of
any facility for the processing, storage or disposal of radioactive waste;

(e)
practices in which workers are liable to receive
an annual effective dose of more than 6 mSv in normal operation and under
normal working conditions;

(f)
practices discharging significant amounts of
airborne or liquid effluent into the environment.

3.           Member States shall
require either registration or licensing of the following practices:

(a)
the deliberate administration of radioactive
substances to persons and, in so far as the radiation protection of human
beings is concerned, animals for the purpose of medical or veterinary
diagnosis, treatment or research;

(b)
the use of radiation generators or radioactive
sources for industrial radiography, the processing of products or research, and
the use of accelerators, except electron microscopes;

(c)
the use of radiation generators or radioactive
sources for medical exposures;

(d)
the manufacture and operation of electrical
equipment emitting ionising radiation and operating at a potential difference
of more than 30 kV, as well as the import or export of such equipment;

(e)
practices in which workers are liable to receive
an annual effective dose of more than 1 mSv in normal operation and under
normal working conditions;

(f)
industries involving naturally occurring
radioactive material identified by Member States as required in Article 24, and
liable to lead to an effective dose to a member of the public equal to or
exceeding 0.3 mSv per year.

4.           Member States may require
registration or licensing for types of practices other than those listed in
paragraphs 2 and 3.

Article 28

Authorisation procedure

1.           For authorisation
purposes, Member States shall require the provision of information commensurate
with the nature of the practice and the risks involved.

2.           The information required
for the purpose of granting a license cover at least the following:

(a)
responsibilities and organisational arrangements
for protection and safety;

(b)
staff competences, including information and
training;

(c)
design features of the installation and
radiation sources;

(d)
anticipated occupational and public exposures in
normal operation;

(e)
safety assessment of the activities and the
installation in order to:

(i) identify ways in which potential exposures
or accidental and unintended medical exposures could occur;

(ii) estimate, to the extent practicable, the
probabilities and magnitude of potential exposures;

(iii) assess the quality and extent of
protection and safety provisions, including engineering features as well as
administrative procedures;

(iv) define the operational limits and
conditions of operation;

(f)
emergency procedures and communication links;

(g)
maintenance, testing, inspection and servicing
so as to ensure that the radiation source and the installation continue to meet
the design requirements, operational limits and conditions of operation
throughout their lifetime;

(h)
management of radioactive waste and arrangements
for the disposal of such waste in accordance with applicable regulatory
requirements;

(i)
management of disused sealed sources;

(j)
quality assurance.

3.           A licence shall include
specific conditions so as to ensure that the elements of the licence are
legally enforceable or to impose appropriate restrictions on the operational
limits or conditions of operation. The conditions shall also require the
formal, documented implementation of the principle of optimisation.

4.           Where applicable, a
licence shall include a discharge authorisation issued in accordance with the
requirements laid down in Chapter VIII for authorisation of the release of
liquid or airborne radioactive effluent into the environment.

5.           Member States shall
require the undertaking to promptly notify the occurrence of any significant
event resulting or liable to result in the exposure of an individual beyond the
operational limits or conditions of operation specified in licensing
requirements with regard to occupational or public exposure or as defined by
the authorities for medical exposure.

Article 29

Release from regulatory control

1.           The disposal, recycling or
reuse of radioactive materials arising from any authorised practice is subject
to authorisation.

2.           The materials for
disposal, recycling or reuse may be released from the requirements of this
Directive provided that the concentrations of activity per unit mass:

(a)
do not exceed the values set out in Annex VI,
Table A, part 1; or

(b)
comply with specific clearance levels and
associated requirements for specific materials or for materials originating
from specific types of practices; these specific clearance levels, in addition
to the general clearance levels referred to in point (a), shall be established
by the national competent authority following the general exemption criteria
set out in Annex VI, point 3 and taking into account technical guidance
provided by the Community.

3.           For the clearance of
materials containing naturally occurring radionuclides, the values for the
concentrations of activity per unit mass shall be those laid down in Annex VI, Table
A, part 2. Nevertheless the following requirements shall apply:

(a)
for practices subject to licensing as specified
in Article 27(3)(f), the dose criteria for clearance of naturally occurring
radionuclides shall be complied with;

(b)
for other licensed practices, in particular
those forming part of the nuclear fuel cycle, the clearance levels shall comply
with the dose criteria for clearance of materials containing artificial
radionuclides;

(c)
for authorised practices subject to notification
as specified under Article 25(3), the corresponding requirements for the
placing on the market of building materials shall be complied with.

4.           The deliberate dilution of
radioactive residues, other than the mixing of materials that takes place in
normal operation when radioactivity is not a consideration, shall not be
permitted. The competent authority may authorise in specific situations the
mixing of radioactive residues containing naturally occurring radioactive
material with other materials to promote the reuse and recycling of these
materials and to reduce public exposure.

CHAPTER VI

PROTECTION OF WORKERS, APPRENTICES AND
STUDENTS

Article 30

Responsibilities

1.           The requirements for
occupational exposure laid down in this Chapter and in Articles 9, 10, 11 and
12, shall apply to the protection of workers in any exposure situation where
their exposure at work or as the result of work is the legal responsibility of
an undertaking or another legal person, including for instance:

(a)
the employer of outside workers;

(b)
the organisation responsible for the protection
of emergency workers;

(c)
the organisation responsible for the remediation
of contaminated land, buildings and other constructions;

(d)
the employer who has legal responsibility for
the exposure of workers to radon at work, in the situation specified in Article
53(4).

2.           The responsibility of an
undertaking for occupational exposure shall extend to apprentices and students
who in the course of their studies are obliged to work with radiation sources
and to individuals who are self-employed or work on a voluntary basis or for a
charity organisation.

3.           The undertaking shall be
responsible for assessing and implementing arrangements for the radiation
protection of exposed workers.

Article 31

Operational protection of workers

The operational protection of exposed
workers shall be based on:

(a)
prior evaluation to identify the nature and
magnitude of the radiological risk to exposed workers;

(b)
implementation of the optimisation of radiation
protection in all working conditions;

(c)
classification of workers into different
categories;

(d)
implementation of control measures and
monitoring relating to the different areas and working conditions, including,
where necessary, individual monitoring;

(e)
medical surveillance.

Article 32

Consultations with radiation protection
expert

Member States shall require the undertaking
to consult a radiation protection expert on the examination and testing of
protective devices and measuring instruments, in particular for:

(a)
prior critical examination of plans for
installations from the point of view of radiation protection;

(b)
the acceptance into service of new or modified
radiation sources from the point of view of radiation protection;

(c)
regular checking of the effectiveness of
protective devices and techniques;

(d)
regular calibration of measuring instruments and
regular checking that they are serviceable and correctly used.

Article 33

Arrangements in workplaces

1.           For the purposes of
radiation protection, arrangements shall be made as regards all workplaces
where there is a possibility of exposure to ionising radiation in excess of an
effective dose of 1 mSv per year or an equivalent dose of 15 mSv per year for
the lens of the eye or 50 mSv per year for the skin and extremities. Such
arrangements shall be appropriate to the nature of the installations and
sources and to the magnitude and nature of the risks.

2.           For practices involving
naturally occurring radioactive material where the effective dose to workers is
liable to exceed 6 mSv per year, the requirements set out in this Chapter
shall apply. Where the effective dose to workers is less than or equal to
6 mSv per year the competent authorities shall at least require
undertakings to keep exposures under review, taking into account the potential
for protection to be improved or the potential for doses to increase over time
or as a result of changes in the process or the work arrangements.

3.           For undertakings operating
aircraft where the effective dose to the crew from cosmic radiation is liable
to exceed 6 mSv per year, the relevant requirements set out in this
Chapter shall apply. Where the effective dose to the crew is less than or equal
to 6 mSv per year and liable to be above 1 mSv per year, the competent
authorities shall at least require undertakings to keep exposures under review,
taking into account the potential for doses to change over time or as a result
of changes in the work arrangements. The undertakings shall take appropriate
measures, in particular:

(a)
to assess the exposure of the crew concerned;

(b)
to take into account the assessed exposure when
organising working schedules with a view to reducing the doses of highly
exposed crew;

(c)
to inform the workers concerned of the health
risks their work involves and their individual dose.

Article 34

Classification of workplaces

1.           Workplaces shall be
classified into different areas, where appropriate, on the basis of an
assessment of the expected annual doses and the probability and magnitude of
potential exposures.

2.           A distinction shall be
made between controlled areas and supervised areas. The competent authorities
shall establish guidance on the classification of controlled and supervised
areas with regard to particular circumstances.

3.           The undertaking shall keep
under review the working conditions in controlled and supervised areas.

Article 35

Requirements for controlled areas

1.           The minimum requirements
for a controlled area shall be the following:

(a)
the controlled area shall be delineated and
access to it shall be restricted to individuals who have received appropriate
instructions and shall be controlled in accordance with written procedures
provided by the undertaking. Wherever there is a significant risk of the spread
of radioactive contamination, specific arrangements shall be made, including
for the access and exit of individuals and goods and for monitoring
contamination within the controlled area and in the adjacent area;

(b)
taking into account the nature and extent of
radiological risks in the controlled area, radiological surveillance of the
working environment shall be organised in accordance with Article 37;

(c)
signs indicating the type of area, the nature of
the sources and their inherent risks shall be displayed;

(d)
working instructions appropriate to the
radiological risk associated with the sources and the operations involved shall
be laid down.

2.           The undertaking shall be
responsible for implementation of these requirements following consultations
with the radiation protection expert.

Article 36

Requirements for supervised areas

1.           The requirements for a
supervised area shall be the following:

(a)
taking into account the nature and extent of
radiological risks in the supervised area, radiological surveillance of the
working environment shall be organised in accordance with Article 37;

(b)
signs indicating the type of area, the nature of
the sources and their inherent risks shall be displayed;

(c)
working instructions appropriate to the
radiological risk associated with the sources and the operations involved shall
be laid down.

2.           The undertaking shall be
responsible for implementation of these requirements following consultations
with the radiation protection expert.

Article 37

Radiological surveillance of the working
environment

1.           The radiological
surveillance of the working environment referred to in Articles 35(1)(b) and 36(1)(a)
shall comprise, where appropriate:

(a)
the measurement of external dose rates,
indicating the nature and quality of the radiation in question;

(b)
the measurement of the air activity
concentration and the surface density of contaminating radionuclides,
indicating their nature and their physical and chemical states;

(c)
the measurement of radon concentrations in the
workplace.

2.           The results of these
measurements shall be recorded and shall be used, if necessary, for estimating
individual exposure, as provided for in Article 39.

Article 38

Categorisation of exposed workers

1.           For the purposes of
monitoring and surveillance, a distinction shall be made between two categories
of exposed workers:

(a)
category A: exposed workers who are liable to
receive an effective dose greater than 6 mSv per year or an equivalent dose
greater than 15 mSv per year for the lens of the eye or greater than 150 mSv
per year for skin and extremities;

(b)
category B: exposed workers who are not
classified as category A workers.

2.           The distinction between
two categories of exposed workers referred to in paragraph 1 shall be made
prior to employment for work involving exposure and shall be subject to regular
review on the basis of working conditions and medical surveillance.

3.           For emergency workers, the
distinction between two categories of exposed workers referred to in paragraph
1 of this Article, where appropriate, shall have no effect on the requirements
for monitoring set out in Articles 37, 39 – 43 as long as the workers are not
involved in an actual emergency exposure situation.

Article 39

Individual monitoring

1.           Category A workers shall
be systematically monitored based on individual measurements performed by a
dosimetry service. In cases where category A workers are liable to receive
significant internal exposure or significant exposure of the lens of the eye or
extremities an adequate system for monitoring shall be set up. The competent
authority shall give special attention to the identification of such workers.

2.           Monitoring for category B
workers shall be at least sufficient to demonstrate that such workers are
correctly classified in category B. Member States may require individual
monitoring and if necessary individual measurements, performed by a dosimetry
service, for category B workers.

3.           In cases where individual
measurements are impossible or inadequate, the individual monitoring shall be
based on an estimate arrived at either from individual measurements made on
other exposed workers or from the results of the surveillance of the working
environment provided for in Article 37.

Article 40

Monitoring in the case of accidental
exposure

In the case of accidental exposure, the
undertaking in collaboration with the dosimetry service shall assess the
relevant doses and their distribution in the body.

Article 41

Recording and reporting of results

1.           A record containing the
results of individual monitoring shall be made for each exposed worker for whom
such monitoring is performed.

2.           For the purposes of
paragraph 1, the following information on exposed workers shall be retained:

(a)
a record of the exposures measured or estimated,
as the case may be, of individual doses pursuant to Articles 39, 40, 51,and 52;

(b)
in the case of exposures as referred to in
Articles 40 and 52, the reports relating to the circumstances and the action
taken;

(c)
the results of workplace monitoring used to
assess individual doses where necessary.

3.           The information referred
in paragraph 1 shall be retained during the period of their working life
involving exposure to ionising radiation and afterwards until they have or
would have attained the age of 75 years, but in any case not less than 30 years
after termination of the work involving exposure.

4.           Exposure as referred to in
Articles 40, 51, and 52 shall be recorded separately in the record referred to
in paragraph 1.

5.           Where the results of
monitoring are used for the management of planned exposure situations,
appropriate arrangements shall be made for not including in the records
exposures attributed to an existing exposure situation namely background external
radiation or radon ingress from soil in the case of industries processing
naturally occurring radioactive material.

Article 42

Access to the results

1.           The Member States shall
require that the results of the individual monitoring set out in Articles 39,
40 and 52 be:

(a)
made available to the competent authorities, to
the undertaking, and to the employer of outside workers;

(b)
made available to the worker concerned in
accordance with Article 43(1);

(c)
submitted to the occupational health services in
order for them to interpret the implications of the results for human health,
as provided for in Article 44;

(d)
submitted to the data system for individual
radiological monitoring established by the Member State in accordance with
paragraph 2.

2.           Member States shall determine
the arrangements under which the results of individual monitoring are conveyed.

3.           The data system for
individual radiological monitoring shall communicate at least the data listed
in Annex VIII, Section A.

4.           In the case of an
accidental or emergency exposure, the results of individual monitoring shall be
communicated without delay.

Article 43

Workers' access to the results

1.           Member States shall
require workers to have access at their request to the results of their
individual monitoring, including the results of measurements which may have
been used in estimating these results, or to the results of the assessment of
their doses made as a result of workplace measurements.

2.           Member States shall
facilitate the exchange among competent authorities, occupational health
services, radiation protection experts, or dosimetry services within the Union
of all relevant information on the doses previously received by a worker in
order to perform the medical examination prior to employment or classification
as a category A worker pursuant to Article 44 and to control the further
exposure of workers.

Article 44

Medical surveillance of exposed workers

1.           The medical surveillance
of exposed workers shall be based on the principles that govern occupational
medicine generally.

2.           The medical surveillance
of category A workers shall be the responsibility of occupational health
services.

This medical surveillance shall allow for the
state of health of workers under surveillance to be ascertained as regards
their fitness for the tasks assigned to them. To this end, the occupational
health services shall have access to any relevant information they require,
including the environmental conditions in the working premises.

3.           Medical surveillance shall
include:

(a)
A medical examination prior to employment or
classification as a category A worker to determine the worker’s fitness for a
post as a category A worker for which the worker is being considered.

(b)
Periodic reviews of health.

The state of health of all category A workers
shall be reviewed at least once a year, in order to determine whether they
remain fit to perform their duties. The nature of these reviews, which can be
performed as many times as the occupational health services consider necessary,
shall depend on the type of work and on the individual worker’s state of
health.

4.           The occupational health
services may indicate the need for medical surveillance to continue after
cessation of work for as long as they consider it necessary to safeguard the
health of the person concerned.

Article 45

Medical classification

The following medical classification shall
be established with respect to fitness for work as a category A worker:

(a)
fit;

(b)
fit, subject to certain conditions;

(c)
unfit.

Article 46

Prohibition to employ or classify unfit
workers

No worker may be employed or classified for
any period in a specific post as a category A worker if medical surveillance
establishes that the worker is unfit for that specific post.

Article 47

Medical records

1.           A medical record shall be
opened for each category A worker and kept up to date so long as the worker
remains a worker in that category. Thereafter, it shall be retained until the
individual has or would have attained the age of 75 years, but in any case not
less than 30 years after termination of the work involving exposure to ionising
radiation.

2.           The medical record shall
include information regarding the nature of the employment, the results of the
medical examinations prior to employment or classification as a category A
worker, the periodic reviews of health and the record of doses required by
Article 41.

Article 48

Special medical surveillance

1.           In addition to the medical
surveillance of exposed workers provided for in Article 44, provision shall be
made for any further action considered necessary by the occupational health
services for the health protection of exposed individuals, such as further
examinations, decontamination measures or urgent remedial treatment.

2.           Special medical
surveillance shall be performed in each case where an annual effective dose of
50 mSv in a year or any of the other dose limits laid down in Article 10(2) has
been exceeded.

3.           Subsequent exposure
conditions shall be subject to the agreement of the occupational health
services.

Article 49

Appeals

Member States shall lay down the procedure
for appeal against the findings and decisions made pursuant to Articles 45, 46
and 48.

Article 50

Protection of outside workers

1.           Member States shall ensure
that the system for individual radiological monitoring affords outside workers
equivalent protection to that for workers employed on a permanent basis by the
undertaking.

2.           The undertaking shall be
responsible, either directly or through contractual agreements with the
employer of outside workers, for the operational aspects of the radiation
protection of outside workers.

3.           In particular, the
undertaking shall:

(a)
check that the outside worker concerned has been
passed as medically fit for the activities to be assigned to the worker;

(b)
ensure that, in addition to the basic training
in radiation protection referred to in Article 16, the outside worker has
received specific training in connection with the characteristics of both the
controlled area and the activities;

(c)
ensure that the outside worker has been issued
with the necessary personal protective equipment;

(d)
ensure that the outside worker receives
individual exposure monitoring appropriate to the nature of the activities, and
any operational dosimetric monitoring that may be necessary;

(e)
ensure compliance with the system of protection
as defined in Chapter III;

(f)
ensure or take all appropriate steps to ensure
that after every activity the radiological data referred to in Annex VIII,
Section B, point 2. from individual exposure monitoring of each outside worker
are recorded.

4.           Employers of outside
workers shall, either directly or through contractual agreements with the
undertaking, ensure that the radiation protection of their workers is in
accordance with the relevant provisions of this Directive, in particular by:

(a)
ensuring compliance with the system of
protection as defined in Chapter III;

(b)
providing the information and training in the
field of radiation protection referred to in Article 16;

(c)
guaranteeing that their workers are subject to
the assessment of exposure and medical surveillance under the conditions laid
down in Articles 37, 39 to 48;

(d)
ensuring that the radiological data from the
individual exposure monitoring of each of their workers within the meaning of
Annex VIII, Section B, point 1, are kept up to date in the data system for
individual radiological monitoring referred to in Article 42(1)(d).

5.           All outside workers shall
be obliged to make their own contribution as far as practicable towards the
protection to be afforded to them by the radiological monitoring system
referred to in paragraph 1.

Article 51

Specially authorised exposures

1.           In exceptional
circumstances evaluated case by case, excluding emergencies, the competent
authorities may, where a specific operation so requires, authorise individual
occupational exposures of identified volunteer workers exceeding the dose
limits set out in Article 10, provided that such exposures are limited in time,
confined to certain working areas and within the maximum exposure levels
defined for the particular case by the competent authorities. The following
conditions shall be taken into account:

(a)
only category A workers as defined in Article 38
may be subject to such exposures;

(b)
apprentices, students, pregnant women, and, if
there is a risk of intake of radionuclides, breastfeeding women shall be
excluded from such exposures;

(c)
the undertaking shall carefully justify such
exposures in advance and thoroughly discuss them with the voluntary workers,
their representatives, the occupational health services or the radiation
protection expert;

(d)
information about the risks involved and the
precautions to be taken during the operation shall be provided to the relevant
workers in advance;

(e)
all doses relating to such exposures shall be
separately recorded in the medical record referred to in Article 47 and the
individual record referred to in Article 41.

2.           The exceeding of dose
limits as a result of specially authorised exposures shall not necessarily
constitute a reason for excluding workers from their usual occupation or
relocating them, without their agreement.

3.           The exposure of space crew
above the dose limits shall be managed as a specially authorised exposure.

Article 52

Emergency occupational exposure

1.           Emergency response
organisations shall ensure that no emergency worker undertakes actions
resulting in doses in excess of 50 mSv, except in specific cases identified in
the national emergency plan. In such cases, appropriate reference levels above
50 mSv shall be defined. In exceptional situations, in order to save life,
prevent severe radiation-induced health effects, or prevent the development of
catastrophic conditions, a reference level above 100 mSv may be set.

2.           Emergency response
organisations shall ensure that emergency workers who are liable to undertake
actions whereby 50 mSv may be exceeded are volunteers who have been clearly and
comprehensively informed in advance of the associated health risks and the
available protection measures.

3.           In the event of an
emergency exposure, Member States shall require radiological monitoring and
medical surveillance of emergency workers. Individual monitoring or assessment
of the individual doses shall be carried out as appropriate to the
circumstances.

Article 53

Radon in workplaces

1.           Within the action plan
referred to in Article 103, Member States shall establish national reference
levels for indoor radon concentrations. Such reference levels shall not exceed
an annual average of 1 000 Bq m-3 for workplaces.

2.           Under the national action
plan, Member States shall ensure that radon measurements are carried out in
workplaces located on the ground floor or at basement level within radon-prone
areas and in specific types of workplaces as identified in the action plan.

3.           Member States shall
require undertakings in which the national reference level for existing
workplaces is exceeded to take appropriate action in order to reduce radon
concentrations or exposures, in accordance with the principle of optimisation
set out in Chapter III.

4.           Where workplaces or
specific rooms within a building continue to exceed the reference level despite
the action taken in accordance with paragraph 3, the Member States shall manage
this situation as a planned exposure situation and apply the relevant
requirements for occupational exposure as specified in Article 30.1(d).

CHAPTER VII

PROTECTION OF PATIENTS AND OTHER
INDIVIDUALS SUBJECTED TO MEDICAL EXPOSURE

Article 54

Justification

1.           Medical exposure shall
show a sufficient net benefit, weighing the total potential diagnostic or
therapeutic benefits it produces, including the direct benefits to health or
well-being of an individual and the benefits to society, against the individual
detriment that the exposure might cause, taking into account the efficacy,
benefits and risks of available alternative techniques having the same
objective but involving no or less exposure to ionising radiation.

Account shall also be taken of the individual
detriment from the exposure of the medical radiological staff and other
individuals.

In particular the following requirements shall
be applied:

(a)
all new types of practices involving medical
exposure shall be justified in advance before being generally adopted;

(b)
existing types of practices involving medical
exposure shall be reviewed whenever new, important evidence about their
efficacy or consequences is acquired;

(c)
all individual medical exposures shall be
justified in advance taking into account the specific objectives of the
exposure and the characteristics of the individual involved.

If a type of practice involving a medical
exposure is not justified in general, a specific individual exposure of this
type may be justified in special circumstances, to be evaluated on a
case-by-case basis and documented.

The referrer and the practitioner shall seek,
where practicable, to obtain previous diagnostic information or medical records
relevant to the planned exposure and consider these data to avoid unnecessary
exposure.

2.           Medical exposure for
biomedical and medical research shall be examined by an ethics committee, set
up in accordance with national procedures and/or by the competent authorities;

3.           Specific justification for
medical radiological procedures to be performed as part of a health screening
programme shall be carried out by the health authority in conjunction with
appropriate professional bodies.

4.           The exposure of carers and
comforters shall show a sufficient net benefit, taking into account the direct
health benefits to a patient, the benefits to the carer / comforter and the
detriment that the exposure might cause.

5.           Any medical radiological
procedure on an asymptomatic individual, to be performed for the early
detection of disease, shall be part of a health screening programme, or shall
require specific documented justification for that individual by the
practitioner, in consultation with the referrer, following guidelines from
relevant professional bodies and competent authorities. Special attention shall
be given to the provision of information to the patients, as required by
Article 56(3).

6.           If an exposure cannot be
justified in accordance with paragraphs 1 to 5, it shall be prohibited.

Article 55

Optimisation

1.           All doses due to medical
exposure for radiodiagnostic and interventional radiology purposes shall be
kept as low as reasonably achievable consistent with obtaining the required
imaging information, taking into account economic and social factors.

For all medical exposure of individuals for
radiotherapeutic purposes, exposures of target volumes shall be individually
planned, taking into account that doses of non-target volumes and tissues shall
be as low as reasonably achievable and consistent with the intended
radiotherapeutic purpose of the exposure.

2.           Member States shall ensure
the establishment, regular review and use of diagnostic reference levels for
radiodiagnostic examinations, and when appropriate, for interventional
radiology procedures, and the availability of guidance for this purpose.

3.           Member States shall ensure
that for each biomedical and medical research project:

(a)
the individuals concerned participate voluntarily;

(b)
these individuals are informed about the risks
of exposure;

(c)
a dose constraint is established for individuals
for whom no direct medical benefit is expected from exposure;

(d)
in the case of patients who voluntarily accept
to undergo an experimental diagnostic or therapeutic practice and who are
expected to receive a diagnostic or therapeutic benefit from this practice, the
dose levels concerned shall be considered on an individual basis by the
practitioner and/or referrer.

4.           The optimisation shall include
the selection of equipment, the consistent production of adequate diagnostic
information or therapeutic outcomes, the practical aspects of medical exposure
procedures, quality assurance, and the assessment and evaluation of patient and
staff doses or administered activities, taking into account economic and social
factors.

5.           Member States shall ensure
that:

(a)
dose constraints are established for the
exposure of carers and comforters;

(b)
appropriate guidance is established for the
exposure of carers and comforters;

6.           Member States shall ensure
that in the case of a patient undergoing treatment or diagnosis with
radionuclides, the practitioner or the undertaking, as appropriate, provides
the patient or legal guardian with written instructions with a view to
restricting doses to persons in contact with the patient as far as reasonably
achievable and providing information on the risks of ionising radiation.

These instructions shall be handed out before
leaving the hospital or clinic or a similar institution.

Article 56

Responsibilities

1.           The referrer and the
practitioner shall be involved in the justification process as specified by
Member States.

2.           Member States shall ensure
that any medical exposure takes place under the clinical responsibility of a
practitioner.

3.           The practitioner shall
ensure that the patient or legal guardian is provided with adequate information
relating to the benefits and risks associated with the radiation dose from the
medical exposure to enable informed consent. Similar information as well as
relevant guidance in accordance with Article 55(5)(b) shall be given to carers
and comforters.

4.           Practical aspects of
medical exposure procedures may be delegated by the undertaking or the
practitioner, as appropriate, to one or more individuals entitled to act in
this respect in a recognised field of specialisation.

Article 57

Procedures

1.           Written protocols for
every type of standard medical radiological procedure shall be established for
each equipment.

2.           Member States shall ensure
that referral guidelines for medical imaging, taking into account the radiation
doses, are available to the referrers.

3.           In medical radiological
practices, a medical physics expert shall be appropriately involved, the level
of involvement being commensurate with the radiological risk posed by the
practice. In particular:

(a)
in radiotherapeutic practices other than
standardised therapeutic nuclear medicine practices, a medical physics expert
shall be closely involved;

(b)
in standardised therapeutical nuclear medicine
practices as well as in radiodiagnostic and interventional radiology practices,
a medical physics expert shall be involved;

(c)
for other simple radiodiagnostic procedures, a
medical physics expert shall be involved, as appropriate, for consultation and
advice on matters relating to radiation protection concerning medical exposure.

4.           Clinical audits shall be
carried out in accordance with national procedures.

5.           Member States shall ensure
that appropriate local reviews are undertaken whenever diagnostic reference
levels are consistently exceeded and that corrective action is taken where
appropriate.

Article 58

Training

Member States shall ensure that training
and recognition requirements, as laid down in Articles 15, 19 and 81, are met
for the practitioner, the medical physics expert and the individuals referred
to in Article 56(4).

Article 59

Equipment

1.           Member States shall take
such steps as they consider necessary with a view to avoiding unnecessary
proliferation of medical radiological equipment.

2.           Member States shall ensure
that:

(a)
all medical radiological equipment in use is
kept under strict surveillance regarding radiation protection;

(b)
an up-to-date inventory of medical radiological
equipment for each medical radiological installation is available to the competent
authorities;

(c)
appropriate quality assurance programmes and
dose or administered activity assessments are implemented by the undertaking;
and

(d)
acceptance testing, involving the medical
physics expert, is carried out before the first use of the equipment for
clinical purposes, and performance testing is carried out thereafter on a
regular basis, and after any major maintenance procedure.

3.           Competent authorities
shall take steps to ensure that the necessary measures are taken by the
undertaking to improve inadequate or defective features of medical radiological
equipment. They shall also adopt specific criteria for the acceptability of
equipment in order to indicate when appropriate corrective action is necessary,
including, if appropriate, taking the equipment out of service.

4.           The use of fluoroscopy
equipment without a device to control the dose rate, or without an image
intensifier or equivalent device, shall be prohibited.

5.           Any equipment used for
interventional radiology and computed tomography shall have a device or a
feature informing the practitioner of the quantity of radiation produced by the
equipment during the medical radiological procedure. Any other medical
radiodiagnostic equipment brought into use after this Directive has entered
into force shall have such a device or a feature or equivalent means of
determining the quantity of radiation produced. The radiation dose shall form
part of the report on the examination.

Article 60

Special practices

1.           Member States shall ensure
that appropriate medical radiological equipment, practical techniques and
ancillary equipment are used for medical exposure

(a)
of children;

(b)
as part of a health screening programme;

(c)
involving high doses to the patient, such as
interventional radiology, computed tomography or radiotherapy.

Special attention shall be given to quality
assurance programmes and the assessment of dose or administered activity, as
mentioned in Article 59(2)(c), for these practices.

2.           Member States shall ensure
that practitioners and those individuals referred to in Article 56(4) who
perform the exposures referred to in paragraph 1 of this Article obtain
appropriate training in these medical radiological practices as required by
Article 19.

Article 61

Special protection during pregnancy and
breastfeeding

1.           In the case of a woman of
childbearing age, the referrer and the practitioner shall inquire as specified
by Member States whether she is pregnant or breastfeeding, if relevant.

If pregnancy cannot be excluded, depending on
the type of medical exposure, in particular if abdominal and pelvic regions are
involved, special attention shall be given to the justification, particularly
the urgency, and to the optimisation of the medical exposure, taking into
account the exposure both of the expectant mother and the unborn child.

2.           In the case of
breastfeeding women, in nuclear medicine, depending on the type of medical
examination or treatment, special attention shall be given to the
justification, particularly the urgency, and to the optimisation of the medical
exposure, taking into account the exposure both of the mother and the child.

3.           Without prejudice to
paragraphs 1 and 2, Member States shall take measures to increase the awareness
of women to whom this Article applies, such as public notices in appropriate
places.

Article 62

Accidental and unintended exposures

Member States shall ensure that:

(a)
all reasonable steps are taken to minimise the
probability and magnitude of accidental or unintended exposures of patients
from all medical radiological procedures, taking into account economic and
social factors;

(b)
for radiotherapeutic practices the quality
assurance programme includes a study of the risk of accidental or unintended
exposures;

(c)
for all medical exposures the undertaking
implements a system for the registration and analysis of events involving or
potentially involving accidental or unintended exposures;

(d)
the undertaking declares as soon as possible to
the competent authorities the occurrence of significant events as defined by
the authorities, including the results of the investigation and the corrective
measures to avoid such events. The competent authorities shall share this
information with the competent authorities for post-market surveillance
established in Council Directive 93/42/EEC concerning medical devices;

(e)
arrangements are made to inform the referrer,
the practitioner and the patient about an unintended or accidental exposure.

Article 63

Estimates of population doses

Member States shall ensure that the
distribution of individual dose estimates from medical exposure is determined
and shall take into account the age distribution and the gender of the exposed
population.

CHAPTER VIII

PROTECTION OF MEMBERS OF THE PUBLIC

Section 1

Protection of members of the public in normal
circumstances

Article 64

Principles of protection of members of
the public

Member States shall create the conditions
necessary to ensure the best possible protection of members of the public under
the prevailing circumstances, based on the principles set out in Chapter III on
the system of radiation protection and applying the requirements laid down in this
Chapter.

Article 65

Operational protection of members of the
public

1.           The operational protection
of members of the public in normal circumstances from practices subject to licensing
shall include all arrangements and surveys for detecting and eliminating
factors which, in the course of any operation involving exposure to ionising
radiation, are liable to create a risk of exposure for members of the public
which cannot be disregarded from the radiation protection point of view. Such
protection shall include the following tasks:

(a)
examination and approval of plans for
installations involving an exposure risk, and of the proposed siting of such
installations within the territory concerned, from the point of view of
radiation protection;

(b)
acceptance into service of new installations
involving an exposure risk, subject to adequate protection being provided
against any exposure or radioactive contamination liable to extend beyond the
perimeter, taking into account, if relevant, demographic, meteorological,
geological, hydrological and ecological conditions;

(c)
examination and approval of plans for the
discharge of radioactive effluents.

These tasks shall be carried out in accordance
with rules laid down by the competent authorities on the basis of the exposure
risk involved.

2.           The competent authority
shall establish authorised limits for discharging radioactive effluents. These
discharge authorisations shall

(a)
take into account the results of the
optimisation of public exposure;

(b)
reflect good practice in the operation of
similar facilities;

(c)
allow a margin for operational flexibility of a
facility.

Article 66

Estimation of doses to members of the
public

1.           Member States shall, on
the basis of the exposure risk involved, establish a system for the estimation
of doses to members of the public from planned exposure situations.

2.           The competent authorities
shall identify practices where a realistic assessment of doses to members of
the public shall be carried out. For other practices Member States may require
only a screening assessment with generic data.

3.           For the realistic
assessment of doses to members of the public, the competent authority shall:

(a)
ensure that dose estimates for practices as
referred to in Article 65 are made as realistic as possible for representative
persons;

(b)
decide on the frequency of assessments and take
all necessary steps to identify the representative person, taking into account
the effective pathways for transmission of the radioactive substances;

(c)
ensure, taking into account the radiological
risks, that the estimates of doses to members of the public include:

(i) assessment of the doses due to
external radiation, indicating, where appropriate, the quality of the radiation
in question;

(ii) assessment of the intake of
radionuclides, indicating the nature of the radionuclides and, where necessary,
their physical and chemical states, and determination of the activity and
concentrations of these radionuclides;

(iii) assessment of the doses that the
representative person is liable to receive and specification of the
characteristics of the representative person;

(d)
require records to be kept and be made available
to all stakeholders relating to measurements of external exposure, estimates of
intakes of radionuclides and radioactive contamination, and the results of the
assessment of the doses received by the representative person.

Article 67

Monitoring of radioactive discharges

1.           Member States shall
require the undertaking responsible for practices where a discharge
authorisation is granted to monitor appropriately the radioactive airborne or
liquid discharges into the environment and to report the results of this
monitoring to the competent authority.

2.           Member States shall
require any undertaking responsible for a nuclear power reactor or reprocessing
plant to monitor discharges in normal operation in accordance with the
standardised information selected for monitoring and reporting to the European
Commission as laid down in Commission Recommendation 2004/2/Euratom[22].

Article 68

Tasks for the undertakings

1.           Member States shall
require the undertaking to carry out the following tasks:

(a)
achieving and maintaining an optimal level of
protection;

(b)
checking the effectiveness and maintenance of
technical devices;

(c)
acceptance into service, from the point of view
of surveillance of radiation protection, of equipment and procedures for
measuring and assessing, as appropriate, exposure of members of the public and
radioactive contamination of the environment;

(d)
regular calibration of measuring instruments and
regular checking that they are serviceable and correctly used.

2.           Radiation protection
experts and, as appropriate, radiation protection officers shall be involved in
the performance of the tasks referred to in paragraph 1.

Article 69

Environmental monitoring programme

Member States shall ensure that an
appropriate environmental monitoring programme is in place for estimating the
exposure of members of the public.

Section 2

Emergency exposure situations

Article 70

Emergency response

1.           Member States shall
require the undertaking responsible for a practice to notify the competent
authorities immediately of any emergency occurring in its facility or related
to its activities and to take all appropriate action to reduce the
consequences.

2.           Member States shall ensure
that, in the event of an emergency on its own territory, the undertaking makes
an initial provisional assessment of the circumstances and consequences of the
emergency and assists with protective measures.

3.           Member States shall ensure
that provision is made for protective measures with regard to:

(a)
the radiation source, to reduce or stop the
direct radiation and emission of radionuclides, or to prevent exposure or
contamination resulting from orphan sources;

(b)
the environment, to reduce the transfer of
radioactive substances to individuals;

(c)
individuals, to reduce exposure.

4.           In the event of an
emergency on or outside its territory, the Member State or the emergency
response authority shall require:

(a)
the organisation of appropriate protective
measures, taking account of the real characteristics of the emergency and in
accordance with the optimised protection strategy as part of the emergency
response plan, whereby the elements to be included in an emergency response
plan are indicated in Annex IX, Section B;

(b)
the assessment and recording of the consequences
of the emergency and of the effectiveness of the protective measures.

5.           The Member State or the
emergency response authority shall, if the situation so requires, ensure that
provision is made to organise the medical treatment of victims.

Article 71

Information to members of the public
likely to be affected in the event of an emergency

1.           Member States shall ensure
that members of the public likely to be affected in the event of an emergency
are given information about the health protection measures applicable to them
and about the action they should take in the event of such an emergency.

2.           The information supplied
shall include at least the elements set out in Annex X, Section A.

3.           The information shall be
communicated to the members of the public referred to in paragraph 1 without
any request being made.

4.           Member States shall update
the information and circulate it at regular intervals and whenever significant
changes take place. This information shall be permanently available to the
public.

Article 72

Information to the members of the public
actually affected in the event of an emergency

1.           Member States shall ensure
that, when an emergency occurs, the members of the public actually affected are
informed without delay of the facts of the emergency, the steps to be taken
and, as appropriate, the health protection measures applicable to these members
of the public.

2.           The information provided
shall cover those points contained in Annex X, Section B which are relevant to
the type of emergency.

Section 3

Existing exposure situations

Article 73

Contaminated areas

1.           Strategies for managing
contaminated areas shall include, where applicable, the following:

(a)
delineation of the affected regions and
identification of the affected members of the public;

(b)
consideration of the need for and extent of
protective measures applied to the affected regions and members of the public;

(c)
consideration of the need to prevent or control
access to the affected regions, or to impose restrictions on living conditions
in these regions;

(d)
assessment of the exposure of different groups
in the population and assessment of the means available to individuals for
controlling their own exposure;

(e)
objectives and long-term goals pursued by the
strategy and corresponding reference levels.

2.           For areas with
long-lasting residual contamination in which the Member State has decided to
allow habitation and the resumption of social and economic activities, Member
States shall ensure, in consultation with stakeholders, that arrangements are
in place, as necessary, for the ongoing control of exposure with the aim of
establishing living conditions that can be considered as normal, including:

(a)
establishment of reference levels consistent
with day-to-day life;

(b)
establishment of an infrastructure to support
continuing self-help protective measures in the affected areas, such as
information provision, advice and monitoring.

Article 74

Radon in dwellings and buildings with
public access

1.           Within the action plan
referred to in Article 103, Member States shall establish national reference
levels for indoor radon concentrations, which shall not exceed (as an annual
average):

(a)
200 Bq m-3 for new dwellings and new
buildings with public access;

(b)
300 Bq m-3 for existing dwellings;

(c)
300 Bq m-3 for existing buildings
with public access. In specific cases where the occupancy time is low, a
reference level of up to 1 000 Bq m-3 can be set.

2.           Under the national action
plan, Member States shall

(a)
identify existing dwellings exceeding the
reference level and to encourage radon-reducing measures in existing dwellings
where the reference levels are exceeded;

(b)
ensure that radon measurements are carried out
in buildings with public access within radon-prone areas.

3.           Member States shall
establish specific building codes to prevent radon ingress from the soil and,
as specified in the national action plan, from building materials, and require
compliance with such building codes, in particular in radon-prone areas, so as
to avoid radon concentrations exceeding the reference level for new buildings.

4.           Member States shall
provide local and national information on prevailing radon concentrations, on
the associated health risks and on the technical means available for reducing
existing radon concentrations.

Article 75

Building materials

1.           The requirements laid down
in this Article shall apply to the following:

(a)
building materials which are identified and
listed by the relevant competent authority as being of concern from the
radiation protection point of view, taking into account the indicative list of
materials set out in Annex XI with regard to their emitted gamma radiation; or

(b)
building materials which the authority has
assessed to be of concern in the national action plan for radon, as specified
in Article 103.

2.           For identified types of
building materials, the industries placing such materials on the market

(a)
shall determine the concentrations of the
radionuclides specified in Annex VII;

(b)
shall provide information to the competent
authority on the results of measurements and the corresponding activity
concentration index, as defined in Annex VII.

3.           The competent authority
shall ensure that identified types of building materials are classified, as
laid down in Annex VII, on the basis of their
intended use and activity concentration index.

4.           Identified types of
building materials which are not liable to give doses exceeding the reference
level of 1 mSv per year for indoor external exposure from building materials,
in excess of prevailing outdoor external exposure, shall be exempt from
requirements at national level, without prejudice to Article 103. Such building
materials shall nevertheless be further monitored to ensure that the activity concentration
continues to comply with this reference level. Building materials of category A
as specified in Annex VII shall be exempt from any restrictions with regard to
their placing on the market in the Union.

5.           For identified types of
building materials which are liable to give doses exceeding the reference level
of 1 mSv per year for indoor external exposure from building materials, in
excess of the prevailing outdoor external exposure, the competent authority
shall decide on appropriate measures, ranging from registration and general
application of relevant building codes to specific restrictions on the
envisaged use of such materials.

6.           Information on identified
types of building materials, relevant to the implementation of building codes,
including their radionuclide concentrations, activity concentration index and
corresponding classification, shall be made available prior to their placing on
the market.

CHAPTER IX

PROTECTION OF THE ENVIRONMENT

Article 76

Environmental criteria

Member States shall include, in their legal
framework for radiation protection and in particular within the overall system
of human health protection, provision for the radiation protection of non-human
species in the environment. This legal framework shall introduce environmental
criteria aiming to protect populations of vulnerable or representative
non-human species in the light of their significance as part of the ecosystem.
Where appropriate, types of practices shall be identified for which regulatory
control is warranted in order to implement the requirements of this legal
framework.

Article 77

Authorised limits on discharges

Member States’ competent authorities, when
establishing authorised limits on discharges of radioactive effluents, in
accordance with Article 65(2), shall also ensure adequate protection of
non-human species. For this purpose, a generic screening assessment may be
conducted to provide assurance that the environmental criteria are met.

Article 78

Accidental releases

Member States shall require undertakings to
take appropriate technical measures to avoid significant environmental damage
in the event of an accidental release or to mitigate the extent of such damage.

Article 79

Environmental monitoring

When establishing environmental monitoring
programmes, or requiring such programmes to be carried out, Member States’
competent authorities shall include representative non-human species, if
necessary, and also environmental media which constitute a pathway of exposure
for members of the public.

CHAPTER X

REQUIREMENTS FOR REGULATORY CONTROL

Section 1

Institutional infrastructure

Article 80

Competent authority

1.           Member States shall
designate the competent authority or authorities to carry out tasks provided
for in this Directive.

2.           Member States shall
forward to the Commission the name and address of the competent authority or
authorities and their respective areas of competence to ensure rapid
communication with such authorities.

3.           Where a Member State has
more than one competent authority for the control of high-activity sealed
sources and orphan sources, it shall designate one point of contact for
communication with the competent authorities of other Member States.

4.           Member States shall
forward to the Commission any changes to the information referred to in
paragraphs 2 and 3.

5.           The Commission shall
communicate the information referred to in paragraphs 2, 3 and 4 to all
competent authorities and shall publish it periodically in the Official Journal
of the European Union, at intervals of no more than two years.

Article 81

Recognition of services and experts

1.           Member States shall make
the necessary arrangements for the recognition of:

(a)
occupational health services;

(b)
dosimetry services;

(c)
radiation protection experts;

(d)
medical physics experts.

Member States shall lay down provisions to ensure
the continuity of expertise of these services and experts.

2.           Member States shall
specify the recognition requirements and communicate them to the Commission
together with the name and address of the competent authorities in charge of
recognition. Member States shall communicate any changes to this information.

3.           Member States shall
specify other services or experts requiring particular radiation protection
qualifications and, where appropriate, the process for the recognition of such
qualifications.

4.           The Commission shall make
the information received in accordance with paragraph 2 available to the Member
States.

Article 82

Occupational health services

Occupational health services shall perform
medical surveillance of exposed workers with regard to their exposure to
ionising radiation and their fitness for the tasks assigned to them.

Article 83

Dosimetry services

Dosimetry services shall determine the
internal and external dose to exposed workers subject to individual monitoring
in order to record the dose in cooperation with the undertaking and the
occupational health service. Dosimetry services shall include the calibration,
reading and interpretation of individual monitoring devices, and the
measurement of radioactivity in the human body and in biological samples.

Article 84

Radiation protection expert

1.           The radiation protection
expert shall, on the basis of professional judgment, measurements and
assessments, give competent advice to the undertaking on matters relating to occupational
exposure and public exposure.

2.           The advice of the
radiation protection expert shall cover, but not be limited to, the following:

(a)
plans for new installations and the acceptance
into service of new or modified radiation sources in relation to any
engineering controls, design features, safety features and warning devices
relevant to radiation protection;

(b)
the categorisation of controlled and supervised
areas;

(c)
the classification of workers;

(d)
the content of workplace and individual
monitoring programmes;

(e)
the appropriate radiation monitoring
instrumentation to be used;

(f)
the appropriate methods of personal dosimetry;

(g)
the optimisation and establishment of
appropriate dose constraints,

(h)
quality assurance;

(i)
the environmental monitoring programme;

(j)
radioactive waste disposal requirements;

(k)
the arrangements for prevention of accidents and
incidents;

(l)
preparedness and response in emergency exposure
situations;

(m)
training and retraining programmes for exposed
workers.

3.           Where appropriate, the
task of the radiation protection expert may be carried out by a group of
specialists who together have the necessary expertise.

Article 85

Medical physics expert

1.           Within the health care
environment, the medical physics expert shall, as appropriate, act or give
specialist advice on matters relating to radiation physics as applied to
medical exposure.

2.           Depending on the medical
radiological practice, the medical physics expert shall take responsibility for
dosimetry, including physical measurements for evaluation of the dose delivered
to the patient, give advice on medical radiological equipment, and contribute
in particular to the following:

(a)
optimisation of the radiation protection of
patients and other individuals subjected to medical exposure, including the
application and use of diagnostic reference levels;

(b)
the definition and performance of quality
assurance of the medical radiological equipment;

(c)
the preparation of technical specifications for
medical radiological equipment and installation design;

(d)
the surveillance of the medical radiological
installations with regard to radiation protection;

(e)
the selection of equipment required to perform
radiation protection measurements;

(f)
the training of practitioners and other staff in
relevant aspects of radiation protection.

Where appropriate, the task of the medical
physics expert may be carried out by a medical physics service.

Article 86

Radiation protection officer

1.           Member States shall decide
in which practices the designation of a radiation protection officer is
necessary to perform radiation protection tasks within an undertaking. Member
States shall require undertakings to provide the radiation protection officers
with the means necessary for them to carry out their duties. The radiation
protection officer shall report directly to the undertaking.

2.           Depending on the nature of
the practice, the tasks of the radiation protection officer may include the
following:

(a)
ensuring that work with radiation is carried out
in accordance with the requirements of any specified procedures or local rules;

(b)
supervise implementation of the programme for
workplace monitoring;

(c)
maintaining adequate records of radioactive
sources;

(d)
carrying out periodic assessments of the
condition of the relevant safety and warning systems;

(e)
supervise implementation of the personal
monitoring programme;

(f)
supervise implementation of the health
surveillance programme;

(g)
providing new employees with an introduction to
local rules and procedures;

(h)
giving advice and comments on work plans;

(i)
authorising work plans;

(j)
providing reports to the local management;

(k)
participating in the arrangements for
prevention, preparedness and response for emergency exposure situations;

(l)
liaising with the radiation protection expert.

The task of the radiation protection officer
may be carried out by a radiation protection unit established within an
undertaking.

Section 2

Control of sealed sources

Article 87

General requirements

1.           Member States shall make
arrangements for keeping adequate control of sealed sources with regard to
their location, use and disuse.

2.           Member States shall
require the undertaking to keep records of all such sources under its
responsibility, their location and their transfer.

3.           Member States shall set up
a system to enable them to be adequately informed of individual transfers of
sealed sources, where necessary, and in any event of transfers of high-activity
sealed sources.

4.           Member States shall
require each undertaking holding a sealed source to notify the competent
authority promptly of any loss, theft or unauthorised use of a sealed source.

Article 88

Requirements for control of
high-activity sealed sources

Member States shall ensure that, before
issuing authorisation for practices involving a high-activity sealed source:

(a)
adequate arrangements have been made for the
safe management and security of sources, including when they become disused
sources. Such arrangements may provide for the transfer of disused sources to
the supplier or their placement in a disposal or storage facility or an
obligation for the manufacturer or the supplier to receive them;

(b)
adequate provision, by way of a financial
security or any other equivalent means appropriate for the source in question,
has been made for the safe management of sources when they become disused
sources, including the case where the undertaking becomes insolvent or ceases
its activities.

Article 89

Specific requirements for licensing of
high-activity sealed sources

In addition to the general licensing
requirements set out in Chapter V, Member States shall ensure that the licence
for the manufacture, use or taking possession of a high-activity sealed source
includes:

(a)
minimum performance criteria for the source,
source container and additional equipment;

(b)
work procedures to be followed;

(c)
adequate management of disused sources,
including agreements regarding the transfer, if appropriate, of disused sources
to a manufacturer, a supplier, another authorised undertaking or a waste
disposal or storage facility.

Article 90

Record keeping by the undertakings

Member States shall require that the records
for high-activity sealed sources include the information set out in Annex XII
and that the undertaking provides the competent authorities with a copy of all
or part of these records upon request and at least as set out in Annex XIII.
The undertaking’s records shall be available for inspection by the competent
authority.

Article 91

Record keeping by the competent
authorities

The competent authorities shall keep
records of undertakings authorised to perform practices with high-activity
sealed sources and of the high-activity sealed sources they hold. These records
shall include the radionuclide involved, the activity at the time of
manufacture or, if this activity is not known, the activity at the time of the
first placing on the market or at the time the undertaking acquired the source,
and the type of source. The competent authorities shall keep the records up to
date, taking transfers of the sources and other factors into account.

Article 92

Security of high-activity sealed sources

1.           The
undertaking carrying out activities involving high
activity sealed sources shall comply with requirements set out in Annex XIV.

2.           The
manufacturer, the supplier, and each undertaking shall ensure that
high-activity sealed sources and containers comply with the requirements for
identification and marking as set out in Annex XV.

Section 3

Orphan sources

Article 93

Detection of orphan sources

1.           Member States shall
require any person encountering an orphan source to promptly notify the
emergency organisation or the competent authority and to refrain from any
further action on the source until these bodies have given appropriate
instructions.

2.           Member States shall make
arrangements for the establishment of systems to detect orphan sources in
places such as large metal scrap yards and major metal scrap recycling
installations where orphan sources may generally be encountered, or at
significant nodal transit points, wherever appropriate, such as customs posts.

3.           Member States shall ensure
that specialised technical advice and assistance is promptly made available to
persons who work in the places referred to in paragraph 2 and who are not
normally involved in operations subject to radiation protection requirements.
The primary aim of advice and assistance shall be the protection of workers and
members of the public from radiation and the safety of the source.

Article 94

Metal contamination

Member States shall require that a metal
scrap recycling installation promptly notifies the competent authority of any
melting of an orphan source and shall require that the contaminated metal not
be further processed without authorisation by the competent authority.

Article 95

Recovery, management and disposal of
orphan sources

1.           Member States shall ensure
that the competent authorities are prepared, or have made provision, including
assignment of responsibilities, to recover orphan sources and to deal with
emergencies due to orphan sources and have drawn up appropriate response plans
and measures.

2.           Member States shall ensure
that campaigns are organised, as appropriate, to recover orphan sources left
behind from past practices.

The campaigns may include the financial
participation of Member States in the costs of recovering, managing and
disposing of the sources and may also include surveys of historical records of
authorities, such as customs, and of undertakings, such as research institutes,
material testing institutes or hospitals.

Article 96

Financial security for orphan sources

Member States shall ensure that, on the
basis of arrangements to be decided by Member States, a financial security
system or other equivalent means is established to cover intervention costs
relating to the recovery of orphan sources and which may result from
implementation of Article 95.

Section 4

Emergency exposure situations

Article 97

Emergency management system

1.           Member States shall ensure
that account is taken of the fact that emergencies may occur on their territory
and that they may be affected by emergencies occurring outside their territory.
Member States shall establish an emergency management system and adequate
administrative provisions to maintain such a system.

2.           The emergency management
system shall be designed to be commensurate with the results of a threat
assessment and to be able to respond effectively to emergency exposure
situations in connection with practices or unforeseen events, including
malevolent acts and the discovery of orphan sources.

3.           The emergency management
system shall provide for the establishment of emergency response plans with the
objective of avoiding deterministic effects in any individual from the affected
members of the public and reducing the risk of stochastic effects, taking
account of the general principles of radiation protection and the reference
levels referred to in Chapter III. The emergency management system shall
include the elements listed in Annex IX, Section A.

Article 98

Emergency preparedness

1.           Member States shall ensure
that emergency response plans are established in advance for the various types
of emergencies identified by the threat assessment.

2.           Member States shall ensure
that emergency response plans are tested, reviewed and revised at regular
intervals.

3.           The emergency response
plans shall, where appropriate, incorporate relevant elements of the emergency
management system referred to in Article 97.

4.           The emergency response
plans shall include the elements defined in Annex IX, Section B.

Article 99

International cooperation

1.           Member States shall
cooperate with other Member States and third countries in addressing possible
emergencies on their own territory which may affect other Member States or
third countries, in order to facilitate the organisation of radiological
protection in these Member States or third countries.

2.           Member States shall, in
the event of an emergency occurring on their territory or likely to have
radiological consequences on its territory, establish contact to obtain the
cooperation of any other Member State or third country which may be involved.

3.           Member States shall promptly
exchange information and cooperate with other relevant Member States or third
countries and with relevant international organisations regarding the loss,
removal, theft or discovery of high-activity sealed sources, other radioactive
sources and radioactive material of concern and regarding related follow-up or
investigations, without prejudice to relevant confidentiality requirements and
relevant national legislation.

Section 5

Existing exposure situations

Article 100

Programmes on existing exposure
situations

1.           Member States shall ensure
that programmes are established to identify and evaluate existing exposure
situations and to determine which occupational and public exposures are of
concern from a radiation protection point of view.

2.           The requirements for
existing exposure situations shall apply to:

(a)
exposure due to contamination of areas by
residual radioactive material from:

(i) past activities that were never
subject to regulatory control or were not regulated in accordance with the
requirements laid down by this Directive;

(ii) an emergency, after the emergency
exposure situation has been declared ended, as provided for in the emergency
management system;

(iii) residues from past activities for
which the undertaking is no longer legally accountable;

(b)
exposure to natural radiation sources,
including:

(i) indoor exposure to radon and thoron,
in workplaces, dwellings and other buildings;

(ii) indoor external exposure from
building materials;

(c)
exposure to commodities incorporating

(i) radionuclides from contaminated
areas specified in point (a), or

(ii) naturally occurring radionuclides,
in particular in foodstuffs, drinking water and building materials;

(d)
other existing exposure situations which cannot
be disregarded from a radiation protection point of view.

3.           Member States may decide,
having regard to the general principle of justification, that an existing
exposure situation warrants no consideration of protective measures.

4.           Existing exposure
situations which are the legal responsibility of an undertaking and which are
of concern from a radiation protection point of view shall be subject to the
relevant requirements for planned exposure situations.

Article 101

Establishment of strategies

1.           Member States shall
arrange for the establishment of strategies to ensure that existing exposure
situations are managed appropriately and that the resources made available for
their management are commensurate with the risks and with the effectiveness of
protective measures.

2.           The competent authority
charged with establishing a strategy for managing an existing exposure
situation shall ensure that the strategy contains:

(a)
the objectives pursued by the strategy;

(b)
appropriate reference levels, taking into
account the bands of reference levels laid down in Annex I.

Article 102

Implementation of strategies

1.           Member States shall assign
responsibilities to a competent authority for the implementation of strategies
for the management of existing exposures, and, as appropriate, to registrants,
licensees and other parties involved in the implementation of remedial and
protective measures, and shall provide as appropriate for the involvement of
stakeholders in decisions regarding the development and implementation of
strategies for managing exposures.

2.           The form, scale and
duration of all protective measures considered for implementation of a strategy
shall be optimised.

3.           The distribution of
residual doses that has resulted from the implementation of a strategy shall be
assessed. Further efforts shall be considered with the aim of reducing any
exposures that are still above the reference level.

4.           Throughout the
implementation of a strategy, the competent authority shall regularly:

(a)
evaluate the available remedial and protective
measures for achieving the objectives and the efficiency of planned and
implemented measures;

(b)
provide information to exposed individuals on
the potential health risks and on the available means for reducing their own
exposure;

(c)
provide guidance for the management of exposures
at individual or local level;

(d)
with regard to activities that involve naturally
occurring radioactive material and are not managed as planned exposure
situations, provide information to undertakings on appropriate means for
monitoring concentrations and exposures and for taking protective measures in
the context of overall health and safety requirements.

Article 103

Radon action plan

1.           Member States shall
establish an action plan to manage long-term risks from radon exposures in
dwellings, buildings with public access and workplaces for any source of radon
ingress, whether from soil, building materials or water. The action plan shall
take into account the issues set out in Annex XVI.

2.           Member States shall
forward the action plan and information on any identified radon-prone areas to
the Commission. Member States shall update the action plan and information on
radon-prone areas on a regular basis.

Section 6

System of enforcement

Article 104

Inspections

1.           Member States shall
establish a system or systems of inspection to enforce the provisions adopted
pursuant to this Directive and to initiate surveillance and corrective action
wherever necessary.

2.           The competent authority
shall establish a systematic inspection programme taking into account the
potential magnitude and nature of the hazard associated with practices, a
general assessment of radiation protection issues in the practices, and the
state of compliance with the provisions adopted pursuant to this Directive.

3.           Member States shall ensure
that the findings from each inspection are recorded and the reports
communicated to the undertaking concerned.

4.           Member States shall make
the inspection programme and the main findings from its implementation
available to the public.

5.           The competent authority
shall ensure that mechanisms are in place for the timely dissemination to
relevant parties, including manufacturers and suppliers of sources and, where
appropriate, international organisations, of protection and safety information
concerning lessons learned from inspections and from reported incidents and
accidents and related findings.

Article 105

Enforcement

Member States shall ensure that the
competent authority has the power to require the undertaking to take action to
remedy deficiencies and prevent their recurrence or to withdraw, where
appropriate, authorisation when the results of a regulatory inspection or
another regulatory assessment indicate that the undertaking is not in
compliance with the provisions adopted pursuant to this Directive.

Article 106

Penalties

The Member States shall lay down the rules
on penalties applicable to infringements of the national provisions adopted
pursuant to this Directive and shall take all measures necessary to ensure that
they are implemented. The penalties provided for must be effective, proportionate
and dissuasive. The Member States shall notify those provisions to the
Commission by the date specified in Article 107 at the latest and shall notify
it without delay of any subsequent amendment affecting them.

CHAPTER XI

FINAL PROVISIONS

Article 107

Transposition

1.           Member States shall bring
into force the laws, regulations and administrative provisions necessary to
comply with this Directive by [00.00.0000] at the latest. The provisions laid
down in Chapter IX with regard to the protection of the environment shall be
transposed by [00.00.0000] at the latest. They shall forthwith communicate to
the Commission the text of those provisions and a correlation table between
those provisions and this Directive.

When Member States adopt these provisions, they
shall contain a reference to this Directive or shall be accompanied by such
reference on the occasion of their official publication. Member States shall
determine how such reference is to be made.

2.           Member States shall
communicate to the Commission the text of the provisions of national law which
they adopt in the field covered by this Directive.

Article 108

Repeal

Directives 89/618/Euratom, 90/641/Euratom,
96/29/Euratom, 97/43/Euratom, 2003/122/Euratom shall be repealed with effect
from [00.00.0000].

Article 109

Entry into force

The Directive shall enter into force on the
twentieth day following that of its publication in the Official Journal of the
European Union.

Article 110

Addressees

This Directive is addressed to the Member
States.

Done at Brussels,

For the Council

The President

ANNEX I

Bands
of reference levels for public exposure

1. The optimisation of public exposures in emergency and existing
exposure situations shall be based on a reference level to be established
within the following bands, expressed in mSv effective dose (acute or annual):

(a)
greater than 20 and less or equal to 100

(b)
greater than 1 and less or equal to 20

(c)
1 or less.

The choice of the reference level shall fulfil
the conditions set out in points 2-5.

2. Without prejudice to reference levels
set for organ doses, reference levels expressed in effective doses shall be set
in the range of 1 to 20 mSv per year for existing exposure situations and 20 to
100 mSv for emergency exposure situations.

3. In specific situations, a reference
level below ranges referred to in point 1 may be considered, in particular:

(a) a reference level below 20 mSv may be
set in an emergency exposure situation where appropriate protection can be
provided without causing a disproportionate detriment from the corresponding
countermeasures or an excessive cost;

(b) a reference level below 1 mSv per year
may be set, where appropriate, in an existing exposure situation for specific
source-related exposures or pathways of exposure.

4. For the transition from an emergency
exposure situation to an existing exposure situation, appropriate reference
levels shall be set, in particular upon the termination of long-term
countermeasures such as relocation.

5. The reference levels set shall take
account of the features of prevailing situations as well as societal criteria,
which may include the following:

–
(a) for exposures below 1 mSv or 1 mSv per year,
general information on the level of exposure, without specific consideration of
individual exposures;

–
(b) in the range up to 20 mSv or 20 mSv per
year, specific information to enable individuals to manage their own exposure,
if possible;

–
(c) in the range up to 100 mSv or 100 mSv per
year, assessment of individual doses and specific information on radiation
risks and on available actions to reduce exposures.

ANNEX II

Activity
values defining high-activity sealed sources

For radionuclides not listed in the table
below, the relevant activity level is identical to the D-value defined in the
IAEA publication ‘Dangerous quantities of radioactive material (D-values)’,
(EPR-D-VALUES 2006).

Radionuclide || Activity level (TBq)

Am-241 || 610-2

Am-241/Be || 610-2

Cf-252 || 210-2

Cm-244 || 510-2

Co-60 || 310-2

Cs-137 || 110-1

Gd-153 || 1100

Ir-192 || 810-2

Pm-147 || 4101

Pu-238 || 610-2

Pu-239/Be[23] || 610-2

Ra-226 || 410-2

Se-75 || 210-1

Sr-90 (Y-90) || 1100

Tm-170 || 2101

Yb-169 || 310-1

ANNEX III

Placing
on the market of apparatus or products

A. Any undertaking intending to place on
the market apparatus or products shall provide the competent authorities with
all relevant information, including the following:

(1)
technical characteristics of the apparatus or
product;

(2)
in the case of apparatus containing radioactive
substances, information on the means of fixation of the source in a holder and
on shielding;

(3)
dose rates at relevant distances for the use of
the apparatus or product, including dose rates at a distance of 0.1 m from any
accessible surface;

(4)
intended use of the apparatus or product and
information on the relative performance of the new apparatus or product
compared to existing ones;

(5)
expected doses to regular users of the apparatus
or product.

B. The competent authorities shall assess
the information, listed in Section A and in particular shall assess:

(1)
whether the
performance of the apparatus or product justifies its intended use;

(2)
whether the
design is adequate in order to reduce exposures in normal use and the
likelihood and consequences of misuse or accidental exposures;

(3)
in the case of
a consumer product, whether the product is adequately designed to meet the
exemption criteria and does not necessitate specific precautions for disposal
when no longer in use;

(4)
in the case of
apparatus or products for use in practices exempted from authorisation, whether
conditions for disposal are adequate;

(5)
whether the apparatus
or product is appropriately labelled and suitable documentation is provided to
the customer with instructions for proper use and disposal.

ANNEX IV

Practices involving non-medical
imaging exposure

For the purposes of Article 23, the
following list of practices involving non-medical imaging exposure shall be
taken into account:

A. Procedures implemented by medical staff
using medical radiological equipment:

1.           Radiological health
assessment for employment purposes;

2.           Radiological health
assessment for immigration purposes;

3.           Radiological health
assessment for insurance purposes;

4.           Radiological health
assessment for other purposes not intended to benefit the health and well-being
of the exposed individual;

5.           Radiological evaluation of
the physical development of children and adolescents with a view to a career in
sports, dancing, etc.;

6.           Radiological age
assessment;

7.           Use of ionising radiation
for the identification of concealed objects within the human body.

B. Procedures implemented by non-medical
staff using non-medical equipment:

1.           Use of ionising radiation
for detection of concealed objects on or attached to the human body;

2.           Use of ionising radiation
for detection of concealed humans as part of cargo screening;

3.           Other practices involving
the use of ionising radiation for legal or security purposes.

ANNEX V

List
of industrial practices involving naturally occurring radioactive material

For the purposes of Article 24, the
following list of industrial practices involving naturally occurring
radioactive material, including relevant secondary processes, shall be taken
into account:

(1)
extraction of rare earths from monazite;

(2)
production of thorium compounds and manufacture
of thorium-containing products;

(3)
processing of niobium/tantalum ore;

(4)
oil and gas production;

(5)
geothermal energy production;

(6)
TiO2 pigment production;

(7)
thermal phosphorus production;

(8)
zircon and zirconium industry;

(9)
production of phosphate fertilisers;

(10)
cement production, maintenance of clinker ovens;

(11)
coal-fired power plants, maintenance of boilers;

(12)
phosphoric acid production;

(13)
primary iron production;

(14)
tin/lead/copper smelting;

(15)
ground water filtration facilities;

(16)
mining of ores other than uranium ore.

ANNEX VI

Exemption
and clearance criteria

1.
Exemption

Practices
may be exempted from requirements of this Directive either directly, on the
basis of compliance with numerical exemption criteria (activity values (Bq) or
concentration values (Bq g-1)) laid down in Section 2, or through a
regulatory decision, on the basis of the information provided in conjunction
with the notification of the practice and in line with general exemption
criteria set out in Section 3, to exempt the practice from further
requirements.

2.
Exemption and clearance values

The
total activity values (Bq) for exemption apply to the total activity involved
in a practice and are laid down in column 3 of Table B for artificial
radionuclides and for some naturally occurring radionuclides used in consumer
products. For other practices involving naturally occurring radionuclides, such
values are in general not applicable.

The
exempt activity concentration values (Bq g-1) for the materials
involved in the practice are laid down in Table A, Part 1 for artificial
radionuclides and in Table A, Part 2 for naturally occurring radionuclides. The
values in Table A1, Part 1 are given for individual radionuclides,
where applicable including short-lived radionuclides in equilibrium with the
parent nuclide as indicated. The values in Table A, Part 2 apply to
all radionuclides in the decay chain of U-238 or Th-232, but for segments of
the decay chain which are not in equilibrium with the parent radionuclide
higher values may be applied.

The
concentration values in Table A, Part 1 or in Table A, Part 2 also apply to the
clearance of solid materials for re-use, recycling, conventional disposal or
incineration. Higher values may be defined for specific materials or specific
pathways, taking Community guidance into account, including where appropriate
additional requirements in terms of surface activity or monitoring
requirements.

For
mixtures of artificial radionuclides, the weighted sum of nuclide-specific
activities or concentrations (for various radionuclides contained in the same
matrix) divided by the corresponding exemption value shall be less than unity.
Where appropriate this condition can be verified on the basis of best estimates
of the composition of the radionuclide mix. The values in Table A, Part 2 apply
individually to each parent nuclide. Some elements in the decay chain, e.g.
Po-210 or Pb-210, may warrant the use of values significantly higher, by up to
two orders of magnitude, taking Community guidance into account.

The
values in Table A, Part 2 may not be used to exempt the
incorporation into building materials of residues from industries processing
naturally occurring radioactive material. Such recycling of residues from
identified industries shall be managed as an authorised practice or be exempted
on the basis of the general exemption criteria laid down in Section 3. For this
purpose, compliance of the sum of radionuclide concentrations with the
appropriate value of the radionuclide index I for building materials as defined
in Annex VII shall be verified.

The
values laid down in Table B, column 3, apply to the total inventory of
radioactive substances held by a person or undertaking as part of a specific
practice at any point in time. However, the regulatory authority may apply
these values to smaller entities or packages, for instance to exempt the
transport or storage of exempted consumer products, if the general exemption
criteria in Section 3 are satisfied.

3.
General exemption and clearance criteria

The
general criteria for the exemption of notified practices or the clearance of
materials from authorised practices are as follows:

(a)
the radiological risks to individuals caused by the practice are sufficiently
low as to be of no regulatory concern; and

(b)
the type of practice has been determined to be justified; and

(c)
the practice is inherently safe.

Practices
involving small amounts of radioactive substances or low activity
concentrations, comparable to the exemption values laid down in Tables A, Part
1 or B, and in general all practices involving naturally occurring
radionuclides are deemed to fulfil criterion (c).

Practices
involving amounts of radioactive substances or activity concentrations below
the exemption values laid down in Table A, Part 1 or Table B automatically
comply with criterion (a) without further consideration. This is also the case
for the values in Table A, Part 2, with the exception of the recycling of
residues in building materials or the case of specific exposure pathways, for
instance drinking water.

For
notified practices not complying with these values, an assessment shall be made
of the resulting exposure of individuals. For compliance with the general
criterion (a), it shall be demonstrated that the following dose criteria are
met in all feasible circumstances:

For
artificial radionuclides:

The
effective dose expected to be incurred by an individual due to the exempted
practice is of the order of 10 μSv or less in a year.

For
naturally occurring radionuclides:

The
dose increment, allowing for the prevailing background radiation from natural
radiation sources, liable to be incurred by an individual due to the exempted
practice is of the order of 300 μSv or less in a year for members of the public
and less than 1 mSv for workers.

The
assessment of doses to members of the public shall take into account not only
pathways of exposure through airborne or liquid effluent, but also pathways
resulting from the disposal or recycling of solid residues.

TABLE
A:

Activity concentration values for
exemption or clearance of materials which can be applied by default to any
amount and to any type of solid material.

TABLE
A Part 1: Artificial radionuclides

Radionuclide || Activity concentration (Bq g-1)

H-3 || 100

Be-7 || 10

C-14 || 1

F-18 || 10

Na-22 || 0.1

Na-24 || 1

Si-31 || 1000

P-32 || 1000

P-33 || 1000

S-35 || 100

Cl-36 || 1

Cl-38 || 10

K-42 || 100

K-43 || 10

Ca-45 || 100

Ca-47 || 10

Sc-46 || 0.1

Sc-47 || 100

Sc-48 || 1

V-48 || 1

Cr-51 || 100

Mn-51 || 10

Mn-52 || 1

Mn-52m || 10

Mn-53 || 100

Mn-54 || 0.1

Mn-56 || 10

Fe-52a || 10

Fe-55 || 1000

Fe-59 || 1

Co-55 || 10

Co-56 || 0.1

Co-57 || 1

Co-58 || 1

Co-58m || 10 000

Co-60 || 0.1

Co-60m || 1000

Co-61 || 100

Co-62m || 10

Ni-59 || 100

Ni-63 || 100

Ni-65 || 10

Cu-64 || 100

Zn-65 || 0.1

Zn-69 || 1000

Zn-69ma || 10

Ga-72 || 10

Ge-71 || 10000

As-73 || 1000

As-74 || 10

As-76 || 10

As-77 || 1000

Se-75 || 1

Br-82 || 1

Rb-86 || 100

Sr-85 || 1

Sr-85m || 100

Sr-87m || 100

Sr-89 || 1000

Sr-90a || 1

Sr-91a || 10

Sr-92 || 10

Y-90 || 1000

Y-91 || 100

Y-91m || 100

Y-92 || 100

Y-93 || 100

Zr-93 || 10

Zr-95a || 1

Zr-97a || 10

Nb-93m || 10

Nb-94 || 0.1

Nb-95 || 1

Nb-97a || 10

Nb-98 || 10

Mo-90 || 10

Mo-93 || 10

Mo-99a || 10

Mo-101a || 10

Tc-96 || 1

Tc-96m || 1000

Tc-97 || 10

Tc-97m || 100

Tc-99 || 1

Tc-99m || 100

Ru-97 || 10

Ru-103a || 1

Ru-105a || 10

Ru-106a || 0.1

Rh-103m || 10000

Rh-105 || 100

Pd-103a || 1000

Pd-109a || 100

Ag-105 || 1

Ag-110ma || 0.1

Ag-111 || 100

Cd-109a || 1

Cd-115a || 10

Cd-115ma || 100

In-111 || 10

In-113m || 100

In-114ma || 10

In-115m || 100

Sn-113a || 1

Sn-125 || 10

Sb-122 || 10

Sb-124 || 1

Sb-125a || 0.1

Te-123m || 1

Te-125m || 1000

Te-127 || 1000

Te-127ma || 10

Te-129 || 100

Te-129ma || 10

Te-131 || 100

Te-131ma || 10

Te-132a || 1

Te-133 || 10

Te-133m || 10

Te-134 || 10

I-123 || 100

I-125 || 100

I-126 || 10

I-129 || 0.01

I-130 || 10

I-131 || 10

I-132 || 10

I-133 || 10

I-134 || 10

I-135 || 10

Cs-129 || 10

Cs-131 || 1000

Cs-132 || 10

Cs-134 || 0.1

Cs-134m || 1000

Cs-135 || 100

Cs-136 || 1

Cs-137a || 0.1

Cs-138 || 10

Ba-131 || 10

Ba-140 || 1

La-140 || 1

Ce-139 || 1

Ce-141 || 100

Ce-143 || 10

Ce-144 || 10

Pr-142 || 100

Pr-143 || 1000

Nd-147 || 100

Nd-149 || 100

Pm-147 || 1000

Pm-149 || 1000

Sm-151 || 1000

Sm-153 || 100

Eu-152 || 0.1

Eu-152m || 100

Eu-154 || 0.1

Eu-155 || 1

Gd-153 || 10

Gd-159 || 100

Tb-160 || 1

Dy-165 || 1000

Dy-166 || 100

Ho-166 || 100

Er-169 || 1000

Er-171 || 100

Tm-170 || 100

Tm-171 || 1000

Yb-175 || 100

Lu-177 || 100

Hf-181 || 1

Ta-182 || 0.1

W-181 || 10

W-185 || 1000

W-187 || 10

Re-186 || 1000

Re-188 || 100

Os-185 || 1

Os-191 || 100

Os-191m || 1000

Os-193 || 100

Ir-190 || 1

Ir-192 || 1

Ir-194 || 100

Pt-191 || 10

Pt-193m || 1000

Pt-197 || 1000

Pt-197m || 100

Au-198 || 10

Au-199 || 100

Hg-197 || 100

Hg-197m || 100

Hg-203 || 10

Tl-200 || 10

Tl-201 || 100

Tl-202 || 10

Tl-204 || 1

Pb-203 || 10

Bi-206 || 1

Bi-207 || 0.1

Po-203 || 10

Po-205 || 10

Po-207 || 10

At-211 || 1000

Ra-225 || 10

Ra-227 || 100

Th-226 || 1000

Th-229 || 0.1

Pa-230 || 10

Pa-233 || 10

U-230 || 10

U-231a || 100

U-232a || 0.1

U-233 || 1

U-236 || 10

U-237 || 100

U-239 || 100

U-240a || 100

Np-237a || 1

Np-239 || 100

Np-240 || 10

Pu-234 || 100

Pu-235 || 100

Pu-236 || 1

Pu-237 || 100

Pu-238 || 0.1

Pu-239 || 0.1

Pu-240 || 0.1

Pu-241 || 10

Pu-242 || 0.1

Pu-243 || 1000

Pu-244a || 0.1

Am-241 || 0.1

Am-242 || 1000

Am-242ma || 0.1

Am-243a || 0.1

Cm-242 || 10

Cm-243 || 1

Cm-244 || 1

Cm-245 || 0.1

Cm-246 || 0.1

Cm-247a || 0.1

Cm-248 || 0.1

Bk-249 || 100

Cf-246 || 1000

Cf-248 || 1

Cf-249 || 0.1

Cf-250 || 1

Cf-251 || 0.1

Cf-252 || 1

Cf-253 || 100

Cf-254 || 1

Es-253 || 100

Es-254a || 0.1

Es-254ma || 10

Fm-254 || 10000

Fm-255 || 100

a          Parent radionuclides, and their
progeny whose dose contributions are taken into account in the dose calculation
(thus requiring only the exemption level of the parent radionuclide to be
considered), are listed in the following table:

Parent radionuclide || Progeny

Fe-52 || Mn-52m

Zn-69m || Zn-69

Sr-90 || Y-90

Sr-91 || Y-91m

Zr-95 || Nb-95

Zr-97 || Nb-97m, Nb-97

Nb-97 || Nb-97m

Mo-99 || Tc-99m

Mo-101 || Tc-101

Ru-103 || Rh-103m

Ru-105 || Rh-105m

Ru-106 || Rh-106

Pd-103 || Rh-103m

Pd-109 || Ag-109m

Ag-110m || Ag-110

Cd-109 || Ag-109m

Cd-115 || In-115m

Cd-115m || In-115m

In-114m || In-114

Sn-113 || In-113m

Parent radionuclide || Progeny

Sb-125 || Te-125m

Te-127m || Te-127

Te-129m || Te-129

Te-131m || Te-131

Te132 || I-132

Cs-137 || Ba-137m

Ce-144 || Pr-144, Pr-144m

U-232 || Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208

U-240 || Np-240m, Np-240

Np237 || Pa-233

Pu-244 || U-240, Np-240m, Np-240

Am-242m || Np-238

Am-243 || Np-239

Cm-247 || Pu-243

Es-254 || Bk-250

Es-254m || Fm-254

For
radionuclides not listed in Table A, Part 1 the competent authority shall
assign appropriate values for the quantities and concentrations of activity per
unit mass where the need arises. Values thus assigned shall be complementary to
those in Table A, Part 1.

TABLE A Part 2: naturally occurring
radionuclides

Values for exemption or
clearance for naturally occurring radionuclides in solid materials in secular
equilibrium with their progeny:

Natural radionuclides from the U-238 series || 1 Bq g-1

Natural radionuclides from the Th-232 series || 1 Bq g-1

K-40 || 10 Bq g-1

TABLE B:

Total activity values for exemption
(column 3) and exemption values for the activity concentration in moderate
amounts of any type of material (column 2).

Radionuclide || Activity concentration (Bq g-1) || Activity (Bq)

H-3 || 1 × 106 || 1 × 109

Be-7 || 1 × 103 || 1 × 107

C-14 || 1 × 104 || 1 × 107

O-15 || 1 × 102 || 1 × 109

F-18 || 1 × 101 || 1 × 106

Na-22 || 1 × 101 || 1 × 106

Na-24 || 1 × 101 || 1 × 105

Si-31 || 1 × 103 || 1 × 106

P-32 || 1 × 103 || 1 × 105

P-33 || 1 × 105 || 1 × 108

S-35 || 1 × 105 || 1 × 108

Cl-36 || 1 × 104 || 1 × 106

Cl-38 || 1 × 101 || 1 × 105

Ar-37 || 1 × 106 || 1 × 108

Ar-41 || 1 × 102 || 1 × 109

K-40[24] || 1 × 102 || 1 × 106

K-42 || 1 × 102 || 1 × 106

K-43 || 1 × 101 || 1 × 106

Ca-45 || 1 × 104 || 1 × 107

Ca-47 || 1 × 101 || 1 × 106

Sc-46 || 1 × 101 || 1 × 106

Sc-47 || 1 × 102 || 1 × 106

Sc-48 || 1 × 101 || 1 × 105

V-48 || 1 × 101 || 1 × 105

Cr-51 || 1 × 103 || 1 × 107

Mn-51 || 1 × 101 || 1 × 105

Mn-52 || 1 × 101 || 1 × 105

Mn-52m || 1 × 101 || 1 × 105

Mn-53 || 1 × 104 || 1 × 109

Mn-54 || 1 × 101 || 1 × 106

Mn-56 || 1 × 101 || 1 × 105

Fe-52 || 1 × 101 || 1 × 106

Fe-55 || 1 × 104 || 1 × 106

Fe-59 || 1 × 101 || 1 × 106

Co-55 || 1 × 101 || 1 × 106

Co-56 || 1 × 101 || 1 × 105

Co-57 || 1 × 102 || 1 × 106

Co-58 || 1 × 101 || 1 × 106

Co-58m || 1 × 104 || 1 × 107

Co-60 || 1 × 101 || 1 × 105

Co-60m || 1 × 103 || 1 × 106

Co-61 || 1 × 102 || 1 × 106

Co-62m || 1 × 101 || 1 × 105

Ni-59 || 1 × 104 || 1 × 108

Ni-63 || 1 × 105 || 1 × 108

Ni-65 || 1 × 101 || 1 × 106

Cu-64 || 1 × 102 || 1 × 106

Zn-65 || 1 × 101 || 1 × 106

Zn-69 || 1 × 104 || 1 × 106

Zn-69m || 1 × 102 || 1 × 106

Ga-72 || 1 × 101 || 1 × 105

Ge-71 || 1 × 104 || 1 × 108

As-73 || 1 × 103 || 1 × 107

As-74 || 1 × 101 || 1 × 106

As-76 || 1 × 102 || 1 × 105

As-77 || 1 × 103 || 1 × 106

Se-75 || 1 × 102 || 1 × 106

Br-82 || 1 × 101 || 1 × 106

Kr-74 || 1 × 102 || 1 × 109

Kr-76 || 1 × 102 || 1 × 109

Kr-77 || 1 × 102 || 1 × 109

Kr-79 || 1 × 103 || 1 × 105

Kr-81 || 1 × 104 || 1 × 107

Kr-83m || 1 × 105 || 1 × 1012

Kr-85 || 1 × 105 || 1 × 104

Kr-85m || 1 × 103 || 1 × 1010

Kr-87 || 1 × 102 || 1 × 109

Kr-88 || 1 × 102 || 1 × 109

Rb-86 || 1 × 102 || 1 × 105

Sr-85 || 1 × 102 || 1 × 106

Sr-85m || 1 × 102 || 1 × 107

Sr-87m || 1 × 102 || 1 × 106

Sr-89 || 1 × 103 || 1 × 106

Sr-90b || 1 × 102 || 1 × 104

Sr-91 || 1 × 101 || 1 × 105

Sr-92 || 1 × 101 || 1 × 106

Y-90 || 1 × 103 || 1 × 105

Y-91 || 1 × 103 || 1 × 106

Y-91m || 1 × 102 || 1 × 106

Y-92 || 1 × 102 || 1 × 105

Y-93 || 1 × 102 || 1 × 105

Zr-93b || 1 × 103 || 1 × 107

Zr-95 || 1 × 101 || 1 × 106

Zr-97b || 1 × 101 || 1 × 105

Nb-93m || 1 × 104 || 1 × 107

Nb-94 || 1 × 101 || 1 × 106

Nb-95 || 1 × 101 || 1 × 106

Nb-97 || 1 × 101 || 1 × 106

Nb-98 || 1 × 101 || 1 × 105

Mo-90 || 1 × 101 || 1 × 106

Mo-93 || 1 × 103 || 1 × 108

Mo-99 || 1 × 102 || 1 × 106

Mo-101 || 1 × 101 || 1 × 106

Tc-96 || 1 × 101 || 1 × 106

Tc-96m || 1 × 103 || 1 × 107

Tc-97 || 1 × 103 || 1 × 108

Tc-97m || 1 × 103 || 1 × 107

Tc-99 || 1 × 104 || 1 × 107

Tc-99m || 1 × 102 || 1 × 107

Ru-97 || 1 × 102 || 1 × 107

Ru-103 || 1 × 102 || 1 × 106

Ru-105 || 1 × 101 || 1 × 106

Ru-106b || 1 × 102 || 1 × 105

Rh-103m || 1 × 104 || 1 × 108

Rh-105 || 1 × 102 || 1 × 107

Pd-103 || 1 × 103 || 1 × 108

Pd-109 || 1 × 103 || 1 × 106

Ag-105 || 1 × 102 || 1 × 106

Ag-108m || 1 × 101 || 1 × 106

Ag-110m || 1 × 101 || 1 × 106

Ag-111 || 1 × 103 || 1 × 106

Cd-109 || 1 × 104 || 1 × 106

Cd-115 || 1 × 102 || 1 × 106

Cd-115m || 1 × 103 || 1 × 106

In-111 || 1 × 102 || 1 × 106

In-113m || 1 × 102 || 1 × 106

In-114m || 1 × 102 || 1 × 106

In-115m || 1 × 102 || 1 × 106

Sn-113 || 1 × 103 || 1 × 107

Sn-125 || 1 × 102 || 1 × 105

Sb-122 || 1 × 102 || 1 × 104

Sb-124 || 1 × 101 || 1 × 106

Sb-125 || 1 × 102 || 1 × 106

Te-123m || 1 × 102 || 1 × 107

Te-125m || 1 × 103 || 1 × 107

Te-127 || 1 × 103 || 1 × 106

Te-127m || 1 × 103 || 1 × 107

Te-129 || 1 × 102 || 1 × 106

Te-129m || 1 × 103 || 1 × 106

Te-131 || 1 × 102 || 1 × 105

Te-131m || 1 × 101 || 1 × 106

Te-132 || 1 × 102 || 1 × 107

Te-133 || 1 × 101 || 1 × 105

Te-133m || 1 × 101 || 1 × 105

Te-134 || 1 × 101 || 1 × 106

I-123 || 1 × 102 || 1 × 107

I-125 || 1 × 103 || 1 × 106

I-126 || 1 × 102 || 1 × 106

I-129 || 1 × 102 || 1 × 105

I-130 || 1 × 101 || 1 × 106

I-131 || 1 × 102 || 1 × 106

I-132 || 1 × 101 || 1 × 105

I-133 || 1 × 101 || 1 × 106

I-134 || 1 × 101 || 1 × 105

I-135 || 1 × 101 || 1 × 106

Xe-131m || 1 × 104 || 1 × 104

Xe-133 || 1 × 103 || 1 × 104

Xe-135 || 1 × 103 || 1 × 1010

Cs-129 || 1 × 102 || 1 × 105

Cs-131 || 1 × 103 || 1 × 106

Cs-132 || 1 × 101 || 1 × 105

Cs-134m || 1 × 103 || 1 × 105

Cs-134 || 1 × 101 || 1 × 104

Cs-135 || 1 × 104 || 1 × 107

Cs-136 || 1 × 101 || 1 × 105

Cs-137b || 1 × 101 || 1 × 104

Cs-138 || 1 × 101 || 1 × 104

Ba-131 || 1 × 102 || 1 × 106

Ba-140b || 1 × 101 || 1 × 105

La-140 || 1 × 101 || 1 × 105

Ce-139 || 1 × 102 || 1 × 106

Ce-141 || 1 × 102 || 1 × 107

Ce-143 || 1 × 102 || 1 × 106

Ce-144b || 1 × 102 || 1 × 105

Pr-142 || 1 × 102 || 1 × 105

Pr-143 || 1 × 104 || 1 × 106

Nd-147 || 1 × 102 || 1 × 106

Nd-149 || 1 × 102 || 1 × 106

Pm-147 || 1 × 104 || 1 × 107

Pm-149 || 1 × 103 || 1 × 106

Sm-151 || 1 × 104 || 1 × 108

Sm-153 || 1 × 102 || 1 × 106

Eu-152 || 1 × 101 || 1 × 106

Eu-152m || 1 × 102 || 1 × 106

Eu-154 || 1 × 101 || 1 × 106

Eu-155 || 1 × 102 || 1 × 107

Gd-153 || 1 × 102 || 1 × 107

Gd-159 || 1 × 103 || 1 × 106

Tb-160 || 1 × 101 || 1 × 106

Dy-165 || 1 × 103 || 1 × 106

Dy-166 || 1 × 103 || 1 × 106

Ho-166 || 1 × 103 || 1 × 105

Er-169 || 1 × 104 || 1 × 107

Er-171 || 1 × 102 || 1 × 106

Tm-170 || 1 × 103 || 1 × 106

Tm-171 || 1 × 104 || 1 × 108

Yb-175 || 1 × 103 || 1 × 107

Lu-177 || 1 × 103 || 1 × 107

Hf-181 || 1 × 101 || 1 × 106

Ta-182 || 1 × 101 || 1 × 104

W-181 || 1 × 103 || 1 × 107

W-185 || 1 × 104 || 1 × 107

W-187 || 1 × 102 || 1 × 106

Re-186 || 1 × 103 || 1 × 106

Re-188 || 1 × 102 || 1 × 105

Os-185 || 1 × 101 || 1 × 106

Os-191 || 1 × 102 || 1 × 107

Os-191m || 1 × 103 || 1 × 107

Os-193 || 1 × 102 || 1 × 106

Ir-190 || 1 × 101 || 1 × 106

Ir-192 || 1 × 101 || 1 × 104

Ir-194 || 1 × 102 || 1 × 105

Pt-191 || 1 × 102 || 1 × 106

Pt-193m || 1 × 103 || 1 × 107

Pt-197 || 1 × 103 || 1 × 106

Pt-197m || 1 × 102 || 1 × 106

Au-198 || 1 × 102 || 1 × 106

Au-199 || 1 × 102 || 1 × 106

Hg-197 || 1 × 102 || 1 × 107

Hg-197m || 1 × 102 || 1 × 106

Hg-203 || 1 × 102 || 1 × 105

Tl-200 || 1 × 101 || 1 × 106

Tl-201 || 1 × 102 || 1 × 106

Tl-202 || 1 × 102 || 1 × 106

Tl-204 || 1 × 104 || 1 × 104

Pb-203 || 1 × 102 || 1 × 106

Pb-210b || 1 × 101 || 1 × 104

Pb-212b || 1 × 101 || 1 × 105

Bi-206 || 1 × 101 || 1 × 105

Bi-207 || 1 × 101 || 1 × 106

Bi-210 || 1 × 103 || 1 × 106

Bi-212b || 1 × 101 || 1 × 105

Po-203 || 1 × 101 || 1 × 106

Po-205 || 1 × 101 || 1 × 106

Po-207 || 1 × 101 || 1 × 106

Po-210 || 1 × 101 || 1 × 104

At-211 || 1 × 103 || 1 × 107

Rn-220b || 1 × 104 || 1 × 107

Rn-222b || 1 × 101 || 1 × 108

Ra-223b || 1 × 102 || 1 × 105

Ra-224b || 1 × 101 || 1 × 105

Ra-225 || 1 × 102 || 1 × 105

Ra-226b || 1 × 101 || 1 × 104

Ra-227 || 1 × 102 || 1 × 106

Ra-228b || 1 × 101 || 1 × 105

Ac-228 || 1 × 101 || 1 × 106

Th-226b || 1 × 103 || 1 × 107

Th-227 || 1 × 101 || 1 × 104

Th-228b || 1 × 100 || 1 × 104

Th-229b || 1 x 100 || 1 × 103

Th-230 || 1 × 100 || 1 × 104

Th-231 || 1 × 103 || 1 × 107

Th-234b || 1 × 103 || 1 × 105

Pa-230 || 1 × 101 || 1 × 106

Pa-231 || 1 × 100 || 1 × 103

Pa-233 || 1 × 102 || 1 × 107

U-230 || 1 × 101 || 1 × 105

U-231 || 1 × 102 || 1 × 107

U-232b || 1 × 100 || 1 × 103

U-233 || 1 × 101 || 1 × 104

U-234 || 1 × 101 || 1 × 104

U-235b || 1 × 101 || 1 × 104

U-236 || 1 × 101 || 1 × 104

U-237 || 1 × 102 || 1 × 106

U-238b || 1 × 101 || 1 × 104

U-239 || 1 × 102 || 1 × 106

U-240 || 1 × 103 || 1 × 107

U-240b || 1 × 101 || 1 × 106

Np-237b || 1 × 100 || 1 × 103

Np-239 || 1 × 102 || 1 × 107

Np-240 || 1 × 101 || 1 × 106

Pu-234 || 1 × 102 || 1 × 107

Pu-235 || 1 × 102 || 1 × 107

Pu-236 || 1 × 101 || 1 × 104

Pu-237 || 1 × 103 || 1 × 107

Pu-238 || 1 × 100 || 1 × 104

Pu-239 || 1 × 100 || 1 × 104

Pu-240 || 1 × 100 || 1 × 103

Pu-241 || 1 × 102 || 1 × 105

Pu-242 || 1 × 100 || 1 × 104

Pu-243 || 1 × 103 || 1 × 107

Pu-244 || 1 × 100 || 1 × 104

Am-241 || 1 × 100 || 1 × 104

Am-242 || 1 × 103 || 1 × 106

Am-242mb || 1 × 100 || 1 × 104

Am-243b || 1 × 100 || 1 × 103

Cm-242 || 1 × 102 || 1 × 105

Cm-243 || 1 × 100 || 1 × 104

Cm-244 || 1 × 101 || 1 × 104

Cm-245 || 1 × 100 || 1 × 103

Cm-246 || 1 × 100 || 1 × 103

Cm-247 || 1 × 100 || 1 × 104

Cm-248 || 1 × 100 || 1 × 103

Bk-249 || 1 × 103 || 1 × 106

Cf-246 || 1 × 103 || 1 × 106

Cf-248 || 1 × 101 || 1 × 104

Cf-249 || 1 × 100 || 1 × 103

Cf-250 || 1 × 101 || 1 × 104

Cf-251 || 1 × 100 || 1 × 103

Cf-252 || 1 × 101 || 1 × 104

Cf-253 || 1 × 102 || 1 × 105

Cf-254 || 1 × 100 || 1 × 103

Es-253 || 1 × 102 || 1 × 105

Es-254 || 1 × 101 || 1 × 104

Es-254m || 1 × 102 || 1 × 106

Fm-254 || 1 × 104 || 1 × 107

Fm-255 || 1 × 103 || 1 × 106

b          Parent radionuclides, and their
progeny whose dose contributions are taken into account in the dose calculation
(thus requiring only the exemption level of the parent radionuclide to be
considered), are listed in the following:

Sr-90 || Y-90

Zr-93 || Nb-93m

Zr-97 || Nb-97

Ru-106 || Rh-106

Ag-108m || Ag-108

Cs-137 || Ba-137m

Ba-140 || La-140

Ce-144 || Pr-144

Pb-210 || Bi-210, Po-210

Pb-212 || Bi-212, Tl-208 (0.36), Po-212 (0.64)

Bi-212 || Tl-208 (0.36), Po-212 (0.64)

Rn-220 || Po-216

Rn-222 || Po-218, Pb-214, Bi-214, Po-214

Ra-223 || Rn-219, Po-215, Pb-211, Bi-211, Tl-207

Ra-224 || Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)

Ra-226 || Rn-222, Po-218, Pb-214, Bi-214, Po-214, Pb-210, Bi-210, Po-210

Ra-228 || Ac-228

Th-226 || Ra-222, Rn-218, Po-214

Th-228 || Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)

Th-229 || Ra-225, Ac-225, Fr-221, At-217, Bi-213, Po-213, Pb-209

Th-234 || Pa-234m

U-230 || Th-226, Ra-222, Rn-218, Po-214

U-232 || Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64)

U-235 || Th-231

U-238 || Th-234, Pa-234m

U-240 || Np-240m

Np237 || Pa-233

Am-242m || Am-242

Am-243 || Np-239

ANNEX VII

Definition
and use of the activity concentration index for the gamma radiation emitted by
building materials

For the purposes of Article 75(2), for
identified types of building materials, the activity concentrations of
primordial radionuclides Ra-226, Th-232 (or its decay product Ra-228) and K-40
shall be determined.

The activity concentration index I is given
by the following formula:

I = CRa226/300 Bq/kg + CTh232/200
Bq/kg+ CK40/3000 Bq/kg

where CRa226, CTh232
and CK40 are the activity concentrations in Bq/kg of the
corresponding radionuclides in the building material.

The index relates directly to the gamma
radiation dose, in excess of typical outdoor exposure, in a building
constructed from a specified building material. It applies to the building
material, not to its constituents. For application of the index to such
constituents, in particular residues from industries processing naturally occurring
radioactive material recycled into building materials an appropriate
partitioning factor needs to be applied. The activity concentration index shall
be used as a screening tool for identifying materials that may be exempted or
subject to restrictions. For this purpose the activity concentration index I
may be used for the classification of the materials into four classes, leading
to two categories of building materials (A and B):

|| Category (corresponding default dose)

Use || A (≤ 1 mSv) || B (> 1 mSv)

(1) materials used in bulk amounts || A1 I≤1 || B1 I>1

(2) superficial and other materials with restricted use. || A2 I≤6 || B2 I>6

The division of materials into (1) or (2)
according to their use shall be based on national building codes.

Where appropriate, actual doses for
comparison with the reference level shall be assessed using more elaborate
models which may also take into account the background outdoor external
exposure from local prevailing activity concentrations in the undisturbed earth’s
crust.

ANNEX VIII

Data
system for individual radiological monitoring

General
Provisions

The
data system for individual radiological monitoring established by a Member
State may be realised either as a centralised national network or as a national
dose register. These networks or registers may be supplemented by the issuance
of individual radiological monitoring documents for every outside worker.

1. Any data system of the Member States for
individual radiological monitoring of exposed workers shall comprise the
following sections:

(a)
particulars concerning the worker’s identity;

(b)
particulars concerning the medical surveillance
of the worker;

(c)
particulars concerning the undertaking of the
worker and, in the case of an outside worker, the employer of the worker;

(d)
the results of the individual monitoring of the
exposed worker.

2. The competent authorities of the Member
States shall take the measures necessary to prevent any forgery or misuse of,
or illegal tampering with, the data system for individual radiological
monitoring.

A: Data to be included in the data
system for individual radiological monitoring

3. Data on the worker’s identity shall
include the worker’s

(a)
surname;

(b)
first name;

(c)
sex;

(d)
date of birth;

(e)
nationality; and

(f)
unique identification number.

4.
Data on the medical surveillance of the worker shall include

(a)
the medical classification of the worker in
accordance with Article 45 (fit; fit, subject to certain conditions; unfit);

(b)
information on any restrictions on working with
radiation;

(c)
the date of the last periodic health review;

(d)
the responsible occupational health service; and

(e)
the period of validity of the result.

5.
Data on the undertaking shall include the name, address and unique
identification number of the undertaking.

6.
Data on the employment of the worker shall include:

(a)
the name, address and unique identification
number of the employer;

(b)
the starting date of employment; and

(c)
the categorisation of the worker in accordance
with Article 38.

7.
The results of the individual monitoring of the exposed worker shall include:

(a)
the official dose record for the last 5 calendar
years (year; effective dose in mSv; in the event of non-uniform exposure,
dose-equivalent in the different parts of the body in mSv; and in the event of
internal contamination, the committed dose in mSv); and

(b)
the official dose record for the current year
(period; effective dose in mSv; in the event of non-uniform exposure,
dose-equivalent in the different parts of the body in mSv; and in the event of
internal contamination, the committed dose in mSv).

B:
Data on outside workers to be supplied via the data system for individual
radiological monitoring

1.
Before the start of any activity, the employer of the outside worker shall
supply the following data to the undertaking via the data system for individual
radiological monitoring:

(a)
data on the employer of the outside worker in
accordance with Section A, point 6;

(b)
data on the medical surveillance of the outside
worker in accordance with Section A, point 4;

(c)
the results of the outside worker’s individual
exposure monitoring in accordance with Section A, point 7.

2.
The following data shall be recorded or have been recorded by the undertaking
in the data system for individual radiological monitoring after the end of any
activity:

(a)
the period covered by the activity;

(b)
an estimate of any effective dose received by
the outside worker (operational dose for the period covered by the activity);

(c)
in the event of non-uniform exposure, an
estimate of the dose-equivalent in the different parts of the body;

(d)
in the event of internal contamination, an
estimate of the intake or the committed dose.

C. Provisions concerning the individual radiological
monitoring document

1.           Member States may decide
to issue an individual radiological monitoring document for every outside
worker.

2.           The document shall be
non-transferable.

3.           Member States shall take
the measures necessary to prevent a worker from being issued with more than one
valid individual monitoring document at the same time.

4.           In addition to the information
required in Part A and Part B, the document shall include the name and address
of the issuing body and the issuing date.

ANNEX IX

A. Elements to be included in an emergency
management system

1.           Threat assessment;

2.           Clear allocation of the
responsibilities of persons and organisations having a role in preparedness and
response arrangements, including establishment and coordination of emergency
response organisations with overall responsibilities in managing emergency
exposure situations and, where appropriate, creation of special teams for
protective measures;

3.           Establishment of emergency
response plans at national level, at local level and within installations;

4.           Reliable communications
and efficient and effective arrangements for cooperation and coordination at
the installation and local, national and international levels;

5.           Health protection of
emergency workers;

6.           Education and training of
emergency workers and all other persons with duties or responsibilities in
emergency response, including regular exercises;

7.           Arrangements for
individual monitoring of emergency workers and the recording of doses;

8.           Public information
arrangements;

9.           Involvement of
stakeholders;

10.         Transition from emergency
response to recovery and remediation.

B. Elements to be included in an emergency
response plan

For
emergency preparedness:

1.           Reference levels, taking
into account the criteria laid down in Annex I;

2.           Optimised protection
strategies for members of the public who may be exposed, for different postulated
events and related scenarios;

3.           Predefined generic
criteria for particular protective measures, expressed in terms of projected
and received doses;

4.           Default triggers or
operational criteria such as observables and indicators of on-scene conditions;

5.           Arrangements for prompt
coordination with the emergency response organisation in a neighbouring Member
State or non-Member State, for facilities in the vicinity of a national border;

6.           Arrangements for the
emergency response plan to be reviewed and revised to take account of changes
or lessons learned from exercises and events.

Arrangements shall be established in
advance to revise these elements, as appropriate during an emergency exposure
situation, to accommodate the prevailing conditions as these evolve throughout
the response.

For
emergency response:

The response to an emergency exposure
situation shall be undertaken through the timely implementation of preparedness
arrangements, including but not limited to:

1.           Promptly implementing
protective measures, if possible, before any exposure occurs;

2.           Assessing the
effectiveness of strategies and implemented actions and adjusting them as
appropriate to the prevailing situation;

3.           Comparing the expected
residual doses against the applicable reference level, focusing on those groups
whose doses exceed the reference level;

4.           Implementing further
protection strategies, as necessary, based on prevailing conditions and
available information.

ANNEX X

A. Prior
information to the members of the public likely to be affected by an emergency:

1.           Basic facts about
radioactivity and its effects on human beings and on the environment;

2.           The various types of
emergency covered and their consequences for the public and the environment;

3.           Emergency measures
envisaged to alert, protect and assist the public in the event of an emergency;

4.           Appropriate information on
action to be taken by the public in the event of an emergency.

B. Information to be provided to the
affected members of the public in the event of an emergency

1.           On the basis of the
emergency response plan previously drawn up in the Member States, the members
of the public actually affected in the event of an emergency shall rapidly and
regularly receive:

(a)
information on the type of emergency which has
occurred and, where possible, its characteristics (e.g. its origin, extent and
probable development);

(b)
advice on protection, which, depending on the
type of emergency, may:

i)       cover the following:
restrictions on the consumption of certain foodstuffs and water likely to be
contaminated, simple rules on hygiene and decontamination, recommendations to
stay indoors, distribution and use of protective substances, evacuation
arrangements;

ii)       be accompanied, where
necessary, by special warnings for certain groups of the members of the public;

(c)
announcements recommending cooperation with
instructions or requests by the competent authorities.

2.           If the emergency is
preceded by a pre-alarm phase, the members of the public likely to be affected
shall already receive information and advice during that phase, such as:

(a)
an invitation to the members of the public
concerned to tune in to relevant communication channels;

(b)
preparatory advice to establishments with
particular collective responsibilities;

(c)
recommendations to occupational groups
particularly affected.

3.           This information and
advice shall be supplemented, if time permits, by a reminder of the basic facts
about radioactivity and its effects on human beings and on the environment.

ANNEX XI

Indicative
list of types of building materials considered for control measures with regard
to their emitted gamma radiation

1.           Natural materials

(a)
Alum-shale.

(b)
Building materials or additives of natural
igneous origin, such as:

–
granite,

–
gneiss;

–
porphyries;

–
syenite;

–
basalt;

–
tuff;

–
pozzolana;

–
lava.

2.           Materials incorporating
residues from industries processing naturally occurring radioactive material,
such as:

–
fly ash;

–
phosphogypsum;

–
phosphorus slag;

–
tin slag;

–
copper slag;

–
red mud (residue from aluminium production);

–
residues from steel production.

ANNEX XII
Information to be provided in the records for high activity sealed sources
HASS)

ANNEX XIII

Provision
of data on high-activity sealed sources

The undertaking shall provide the competent
authority with an electronic or written copy of the records for high-activity
sealed sources, referred to in Article 90 and covering the information set out
in Annex XII, as follows:

1.           without undue delay, at
the time of the establishment of such records, which shall be as soon as
possible after the source is acquired;

2.           at intervals, to be
determined by Member States, of not more than 12 months after the acquisition
of the source;

3.           if the situation indicated
on the information sheet has changed;

4.           without undue delay upon
the closure of the records for a specific source when the undertaking no longer
holds this source, whereby the name of the undertaking or waste disposal and
storage facility to which the source is transferred shall be included;

5.           without undue delay upon
the closure of such records when the undertaking no longer holds any sources.

ANNEX XIV

Requirements
for undertakings responsible for a high-activity sealed source

Each undertaking responsible for a
high-activity sealed source shall:

(a)
ensure that suitable tests, such as leak tests
based on international standards, are undertaken regularly in order to check
and maintain the integrity of each source;

(b)
regularly verify at specific intervals, which
may be determined by Member States, that each source and, where relevant, the
equipment containing the source are still present and in apparently good
condition at their place of use or storage;

(c)
ensure that each fixed and mobile source is
subject to adequate documented measures, such as written protocols and
procedures, aimed at preventing unauthorised access to or loss or theft of the
source or its damage by fire;

(d)
promptly notify the competent authority of any
loss, theft or unauthorised use of a source, arrange for a check on the
integrity of each source after any event, including fire, that may have damaged
the source, and, if appropriate, inform the competent authority thereof and of
the measures taken;

(e)
return each disused source to the supplier or
place it in a facility for long term storage and disposal or transfer it to
another authorised undertaking unless otherwise agreed by the competent
authority, without undue delay after termination of the use;

(f)
ascertain that, before a transfer is made, the
recipient holds appropriate authorisation.

(g)
Promptly notify the competent authority of any
accident or incident resulting in unintentional exposure of a worker or a
member of the public.

ANNEX XV

Identification
and marking of high-activity sealed sources

1.           The manufacturer or
supplier shall ensure that:

(a)
Each high-activity sealed source is identified
by a unique number. This number shall be engraved or stamped on the source,
where practicable.

The number shall also be engraved or
stamped on the source container. If this is not feasible, or in the case of
reusable transport containers, the source container shall, at least, bear
information on the nature of the source.

(b)
The source container and, where practicable, the
source are marked and labelled with an appropriate sign to warn people of the
radiation hazard.

2.           The manufacturer shall
provide a photograph of each manufactured source design type and a photograph
of the typical source container.

3.           The undertaking shall
ensure that each high-activity sealed source is accompanied by written
information indicating that the source is identified and marked in compliance
with point 1 and that the markings and labels referred to in point 1 remain
legible. The information shall include photographs of the source, source
container, transport packaging, device and equipment as appropriate.

ANNEX XVI

Indicative list of items to be covered
in the national action plan to manage long term risks from radon exposures

1.           Strategy for conducting
surveys of indoor radon concentrations, for the management of measurement data
(national radon database) and for the establishment of other parameters (soil
and rock types, soil gas concentration, permeability and radium-226 content of
rock or soil).

2.           Available data and
criteria used for the delineation of radon-prone areas or for the
identification of radon-prone buildings.

3.           Identification of types of
buildings with public access and workplaces, e.g. schools, underground
workplaces or spas, where measurements are needed, based on a risk assessment
including occupancy hours.

4.           The basis for the
establishment of reference levels for existing dwellings, workplaces, buildings
with public access and for new buildings.

5.           Assignment of
responsibilities (governmental and non-governmental), coordination mechanisms
and available resources for implementation of the action plan.

6.           Strategy for reducing
radon exposure in dwellings, particularly in radon-prone areas.

7.           Strategy, including
methods and tools, for preventing radon ingress in new buildings, including
identification of building materials with significant radon exhalation.

8.           Schedules for audits and
reviews of the action plan.

9.           Strategy for communication
to increase public awareness and inform local decision makers of the risks of
radon in relation to smoking.

10.         Where appropriate, guidance
on methods and tools for measurements and remedial measures. Criteria for the
accreditation of measurement and remediation services shall also be considered.

11.         Where appropriate,
provision of financial support for radon surveys and for remedial measures, in
particular for private dwellings with very high radon concentrations.

12.         Long-term goals in terms of
reducing lung cancer risk attributable to radon exposure (for smokers and
non-smokers).

[1]               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, OJ
L 159, 29.6.1996, p. 1.

[2]               World Health Organisation.

[3]               WHO Handbook on indoor radon, World Health
Organisation, 2009, ISBN 978 92 4 154767.

[4]               Council Directive 89/106/EEC, Annex 1, states that
‘the construction work must be designed and built in such a way that it will
not be a threat to the hygiene or health of the occupants or neighbours, in
particular as a result of ... the presence of dangerous particles or gases in the
air [or] the emission of dangerous radiation’.

[5]               These acts are subject to recast — proposal for a
Council Regulation (EURATOM) laying down maximum permitted levels of
radioactive contamination of foodstuffs and of feedingstuffs following a
nuclear accident or any other case of radiological emergency (recast), COM/2010/0184
final — CNS 2010/009.

[6]               Publications in the Radiation Protection Series of
the European Commission can be found at http://ec.europa.eu/energy/nuclear/radiation_protection/publications_en.htm.

[7]               The result of the consultation can be found on the
website of the European ALARA network for NORM industries (EANNORM),
under http://www.ean-norm.net/lenya/ean_norm/live/news.html.

[8]               European Court reports 1992 Page I-06153

[9]               OJ 11, 20.2.1959, p. 221.

[10]             OJ L 159, 29.6.1996, p. 1

[11]             OJ L 180, 9.7.1997, p. 22.

[12]             OJ L 357, 7.12.1989, p. 31.

[13]             OJ L 349, 13.12.1990, p. 21.

[14]             OJ L 346, 31.12.2003, p. 57.

[15]             The 2007 Recommendations of the International
Commission on Radiological Protection

[16]             OJ L 80, 27.3.1990, p. 26.

[17]             IAEA
2004 Safety Standards Series RS-G-1.7 "Application of the Concepts of
Exclusion, Exemption and Clearance".

[18]             Radiation
Protection 122: Practical use of the Concepts of the Clearance and Exemption —
Part I, Guidance on General Clearance Levels for Practices.

[19]             Radiation
Protection 89: Recommended radiological protection criteria for the recycling
of metals from dismantling of nuclear installations, Radiation Protection 113:
Recommended Radiological Protection Criteria for the Clearance of Buildings and
Building Rubble from the Dismantling of Nuclear Installations, Radiation
Protection 122: Practical Use of the Concepts of the Clearance and Exemption.

[20]             OJ L 2, 6.1.2004, p. 36

[21]             OJ
L 66, 13.3.1999, p.16.

[22]             OJ L 2/36, 6.1.2000.

[23]             The activity given is that of the alpha-emitting
radionuclide

[24]             Potassium salts in quantities less than 1000 kg are
exempted.