Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom - Main contents

EN

Official Journal of the European Union

L 13/1

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

In order to perform its task, the Community laid down basic standards for the first time in 1959 by means of 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 (1). The Directives have been revised several times, most recently by Council Directive 96/29/Euratom (2) which repealed the earlier Directives.

Directive 96/29/Euratom establishes the basic safety standards. The provisions of that Directive apply to normal and emergency situations and have been supplemented by more specific legislation.

Council Directive 97/43/Euratom (3), Council Directive 89/618/Euratom (4), Council Directive 90/641/Euratom (5) and Council Directive 2003/122/Euratom (6) cover different specific aspects complementary to Directive 96/29/Euratom.

As recognised by the Court of Justice of the European Union in its case-law, the tasks imposed on the Community by point (b) of Article 2 of the Euratom Treaty to lay down uniform safety standards to protect the health of workers and the general public does not preclude, unless explicitly stated in the standards, a Member State from providing for more stringent measures of protection. As this Directive provides for minimum rules, Member States should be free to adopt or maintain more stringent measures in the subject-matter covered by this Directive, without prejudice to the free movement of goods and services in the internal market as defined by the case-law of the Court of Justice.

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 the Euratom Treaty, should take into account the new recommendations of the International Commission on Radiological Protection (ICRP), in particular those in ICRP Publication 103 (7), and should be revised in the light of new scientific evidence and operational experience.

The provisions of 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, this Directive should cover all exposure situations and all categories of exposure, namely occupational, public and medical exposures.

The definition of the term "undertaking" in this Directive, and its use in the context of the protection of the health of workers against ionising radiation, is without prejudice to the legal systems and the allocation of responsibilities to the employer introduced in national legislation transposing Council Directive 89/391/EEC (8).

Calculation of doses from measureable quantities should rely on scientifically established values and relationships. Recommendations for such dose coefficients have been published and updated by ICRP, taking scientific progress into account. A collection of dose coefficients based on its earlier recommendations in ICRP Publication 60 (9), is available as ICRP Publication 119 (10). However, in ICRP Publication 103, a new methodology was introduced by ICRP to calculate doses based on the latest knowledge on radiation risks, and this should, where possible, be taken into account in this Directive.

For external exposure, values and relationships have been published following the new methodology in ICRP Publication 116 (11). These data, as well as the well-established operational quantities, should be used for the purpose of this Directive.

For internal exposure, while ICRP has consolidated in ICRP Publication 119 all earlier publications (on the basis of ICRP Publication 60) on dose coefficients, updates of this publication will be provided and the coefficients that are tabulated in it will be superseded by values based on the radiation and tissue weighting factors and phantoms laid down in ICRP Publication 103. The Commission will invite the group of experts referred to in Article 31 of the Euratom Treaty to continue to monitor scientific developments and the Commission will make recommendations on any updated values, relationships and coefficients, including those for exposure to radon, taking relevant opinions of the group of experts into account.

Article 30 of the Euratom Treaty provides that the "basic standards" are meant to include "maximum permissible doses compatible with adequate safety". This Directive should lay down uniform dose limits for this purpose.

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

New scientific information on tissue reactions calls for the optimisation principle to be applied to equivalent doses as well, where appropriate, in order to keep doses as low as reasonably achievable. This Directive should also follow new ICRP guidance on the limit for equivalent dose for the lens of the eye in occupational exposure.

Industries processing naturally-occurring radioactive material extracted from the earth's crust subject workers and, if material is released into the environment, members of the public to increased exposure.

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.

It is appropriate for this Directive to establish reference levels for indoor radon concentrations and for indoor gamma radiation emitted from building materials, and to introduce requirements on the recycling of residues from industries processing naturally-occurring radioactive materials into building materials.

Regulation (EU) No. 305/2011 (12) lays down harmonised conditions for the marketing of construction products.

Building materials emitting gamma radiation should be within the scope of this Directive but should also be regarded as construction products as defined in Regulation (EU) No 305/2011, in the sense that that Regulation applies to construction works emitting dangerous substances or dangerous radiation.

This Directive should be without prejudice to the provisions of Regulation (EU) No 305/2011 on the declaration of performance, the establishment of harmonised standards or the means and conditions for making available the declaration of performance or with regard to CE marking.

Regulation (EU) No 305/2011 requires information to be made available when products are placed on the market. This does not affect the right of Member States to specify in national legislation requirements for additional information they deem necessary to ensure radiation protection.

Recent epidemiological findings from residential studies demonstrate a statistically significant increase of lung cancer risk from prolonged 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 (13) to be incorporated into the binding requirements of the Basic Safety Standards while leaving enough flexibility for implementation.

National action plans are needed for addressing long-term risks from radon exposure. It is recognized that the combination of smoking and high radon exposure presents a substantially higher individual lung cancer risk than either factor individually and that smoking amplifies the risk from radon exposure at the population level. It is important that Member States address both of these health hazards.

Where, due to national prevailing circumstances, a Member State establishes a reference level for indoor radon concentrations in workplaces that is higher than 300 Bq m–3, the Member State should submit the information to the Commission.

Where radon enters from the ground into indoor workplaces, this should be considered to be an existing exposure situation since the presence of radon is largely independent of the human activities carried out within the workplace. Such exposures may be significant in certain areas or specific types of workplaces to be identified by Member States, and appropriate radon and exposure reduction measures should be taken if the national reference level is exceeded. Where levels continue to remain above the national reference level, these human activities carried out within the workplace should not be regarded as practices. However, Member States should ensure that these workplaces are notified and that, in cases where the exposure of workers is liable to exceed an effective dose of 6 mSv per year or a corresponding time-integrated radon exposure value, they are managed as a planned exposure situation and that dose limits apply, and determine which operational protection requirements need be applied.

The exposure of air crew to cosmic radiation should be managed as a planned exposure situation. The operation of spacecraft should come under the scope of this Directive and, if dose limits are exceeded, be managed as a specially authorised exposure.

The contamination of the environment may pose a threat to human health. The Community's secondary legislation so far has regarded such contamination only as a pathway of exposure to members of the public directly affected by radioactive effluent discharged to the environment. While the state of the environment can impact long-term human health, this calls for a policy protecting the environment against the harmful effects of ionising radiation. For the purpose of long-term human health protection, environmental criteria based on internationally recognised scientific data (such as published by EC, ICRP, United Nations Scientific Committee on the Effects of Atomic Radiation, International Atomic Energy Agency (IAEA)) should be taken into account.

In the medical area, important technological and scientific developments have led to a notable increase in the exposure of patients. In this respect, this 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. It should be noted that according to the World Health Organisation the concept of health is understood to cover the physical, mental and social well-being of an individual and not merely the absence of disease or infirmity.

A high level of competence and a clear definition of responsibilities and tasks among all professionals involved in medical exposure is fundamental to ensure adequate protection of patients undergoing medical radiodiagnostic and radiotherapeutic procedures. This applies to medical doctors, dentists and other health professionals entitled to take clinical responsibility for individual medical exposures, to medical physicists and to other professionals carrying out practical aspects of medical radiological procedures, such as radiographers and technicians in radiodiagnostic medicine, nuclear medicine and radiotherapy.

Accidental and unintended medical exposures are a source of continuing concern. Whereas for medical devices post-market surveillance is required under Council Directive 93/42/EEC (14), it is the role of the competent authority in radiation protection to address the prevention of accidental and unintended medical exposure and the follow-up in case of their occurrence. In this respect, the role of quality assurance programmes, including a study of risks in radiotherapy, to avoid such incidents should be emphasised, and recording, reporting, analysis and corrective action should be required in such cases.

In veterinary practice the use of ionising radiation for imaging is growing, often with second-hand equipment from the medical sector. Especially in the case of larger animals, or in the administration of radiopharmaceuticals to animals, there is a substantial risk of high occupational exposures and of exposure of accompanying persons. This calls for the provision of adequate information and the education of veterinarians and their staff.

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 using medical radiological equipment and on the other hand for procedures not using such equipment. In general, the annual dose limits and corresponding constraints for public exposure should apply.

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.

The application of radiation protection principles in relation to consumer products requires the regulatory control of practices to start at the stage of design and manufacture of products or at the time of import of such products. Therefore, the manufacture or import of consumer products should be regulated and specific procedures should be introduced, so as to allow the timely justification of the intended use of the consumer products, as well as to allow checking that this use can be exempted from regulatory control. While such assessment should continue to be carried out in the Member State in which those practices are conducted, Member States should inform each other, so as to allow them to request relevant information from the undertakings in question and to make their own assessment.

The deliberate addition of radioactive substances to certain categories of consumer products should remain prohibited, but it needs to be made clear that this also applies to the activation of such products by irradiation, without prejudice to existing legislation such as Directive 1999/2/EC of the European Parliament and of the Council (15).

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.

There is a benefit in having the same activity concentration values both for the exemption of practices from regulatory control and for the clearance of materials from authorised practices. After a comprehensive review, it has been concluded that the values recommended in IAEA publication Application of the Concepts of Exclusion, Exemption and Clearance (16) 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 (17).

Member States should be able to grant specific exemption from authorisation for certain practices involving activities above the exemption values.

Specific clearance levels, as well as corresponding Community guidance (18), remain important tools for the management of large volumes of materials arising from the dismantling of authorised facilities.

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

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 an assessment of potential emergency exposure situations, an overall emergency management system, emergency response plans, and pre-planned strategies for the management of each postulated event.

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.

The efficient management of an emergency with cross-border consequences calls for enhanced cooperation between Member States in emergency planning and response.

While urgent information exchange between Member States and the Commission in the event of an emergency is established through Council Decision 87/600/Euratom (19), there is a need to put in place arrangements for information exchange beyond the scope of this Decision to allow cooperation with all other Member States and with third countries which may be involved or are likely to be affected.

The IAEA 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 have revised the International Basic Safety Standards in the light of the ICRP's new Publication 103, and the Commission has informed the IAEA of its decision of 6 August 2012 to co-sponsor that document on behalf of the European Atomic Energy Community.

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. This Directive should clearly distinguish between the different roles and responsibilities of the services and experts without precluding that national frameworks allow the grouping of responsibilities or allow the assignment of responsibilities for specific technical and practical tasks in radiation protection to specified experts.

Commission Recommendation 2004/2/Euratom (20) introduced standardised information for the reporting of data on discharges from nuclear power plants and reprocessing facilities, for transmission of the data to the Commission under Article 36 of the Euratom Treaty.

Member States should have in place precise requirements for the issuing of discharge authorisations and the monitoring of discharges. The reporting of data to the competent authority on discharges from nuclear power plants and reprocessing facilities should be based on standardised information.

Under Article 35 of the Euratom Treaty Member States shall ensure that an appropriate programme to monitor the level of radioactivity in the environment is in place. Under Article 36 of the Euratom Treaty Member States shall report the results of such monitoring to the Commission. Reporting requirements under Article 36 of the Euratom Treaty have been explained in Commission Recommendation 2000/473/Euratom (21).

Council Regulation (EU) No 333/2011 (22) establishes criteria determining when certain types of scrap metal cease to be waste under Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste (23). Measures need to be taken to prevent the accidental melting of orphan sources as well as to ensure compliance of metals released from nuclear installations, for instance during their dismantling, with clearance criteria.

Changes need to be made to Directive 2003/122/Euratom to broaden some of the requirements to include any radioactive source. Unresolved problems with orphan sources remain, and there have been significant cases of contaminated metal being imported from third countries. A requirement should therefore be introduced for the notification of incidents with orphan sources or the contamination of metal. 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.

Pursuant to Article 106a(3) of the Euratom Treaty, the legislation adopted on the basis of the provisions of the Treaty on European Union and of the Treaty on the Functioning of the European Union should not derogate from the provisions of this Directive, and consequently the justification and optimisation principles should apply notably for medical devices and construction products covered by CE marking.

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 transmission of such documents is justified.

Directive 96/29/Euratom and the complementary Directives 89/618/Euratom, 90/641/Euratom, 97/43/Euratom and 2003/122/Euratom should be repealed,

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

the manufacture and the operation of electrical equipment emitting ionising radiation and containing components operating at a potential difference of more than 5 kilovolt (kV);

human activities 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:

the exposure of workers or members 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 human activity.

the preparedness for, the planning of response to and the management of emergency exposure situations that are deemed to warrant measures to protect the health of members of the public or workers.

exposure to the natural level of radiation, such as radionuclides contained in the human body and cosmic radiation prevailing at ground level;

exposure of members of the public or workers other than air or spacecrew to cosmic radiation in flight or in space;

aboveground exposure to radionuclides present in the undisturbed earth's crust.

"Absorbed dose" (D) is the energy absorbed per unit mass

where

In this Directive, absorbed dose denotes the dose averaged over a tissue or an organ. The unit for absorbed dose is the gray (Gy) where one gray is equal to one joule per kilogram: ;

"accelerator" means equipment or installation in which particles are accelerated, emitting ionising radiation with energy higher than 1 mega-electron volt (MeV);

"accidental exposure" means an exposure of individuals, other than emergency workers, as a result of an accident;

"activation" means a 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;

"activity" (A) is the activity 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 nuclear transitions from that energy state in the time interval dt:

The unit of activity is the becquerel (Bq);

"apprentice" means a person receiving training or instruction within an undertaking with a view to exercising a specific skill;

"authorisation" means the registration or licensing of a practice;

"becquerel" (Bq) is the special name of the unit of activity. One becquerel is equivalent to one nuclear transition per second:

;

"building material" means any construction product for incorporation in a permanent manner in a building or parts thereof and the performance of which has an effect on the performance of the building with regard to exposure of its occupants to ionising radiation;

"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;

"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;

"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 appropriate, and the application of new standards if necessary;

"clinical responsibility" means responsibility of a practitioner for individual medical exposures, in particular, justification; optimisation; clinical evaluation of the outcome; cooperation with other specialists and staff, as appropriate, regarding practical aspects of medical radiological 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;

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

In specifying E(τ), 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, is a period of 50 years following intake for adults and up to the age of 70 for infants and children. The unit for committed effective dose is the sievert (Sv);

"committed equivalent dose" (HT(τ)) is 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

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

"competent authority" means an authority or system of authorities designated by Member States as having legal authority for the purposes of this Directive;

"consumer product" means a device or manufactured item into which one or more 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;

"contamination" means the unintended or undesirable presence of radioactive substances on surfaces or within solids, liquids or gases or on the human body;

"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;

"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;

"disused source" means a sealed source which is no longer used or intended to be used for the practice for which authorisation was granted but continues to require safe management;

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

"dose limit" means the value of the effective dose (where applicable, committed effective dose) or the equivalent dose in a specified period which shall not be exceeded for an individual;

"dosimetry service" means a body or an individual competent to calibrate, read or interpret individual monitoring devices, or to measure radioactivity in the human body or in biological samples, or to assess doses, whose capacity to act in this respect is recognised by the competent authority;

"effective dose" (E) is the sum of the weighted equivalent doses in all the tissues and organs of the body from internal and external exposure. It is defined by the expression:

where

The values for wT and wR are specified in Annex II. The unit for effective dose is the sievert (Sv);

"emergency" means a non-routine situation or event involving a radiation source that necessitates prompt action to mitigate serious adverse consequences for human health and safety, quality of life, property or the environment, or a hazard that could give rise to such serious adverse consequences;

"emergency exposure situation" means a situation of exposure due to an emergency;

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

"emergency occupational exposure" means exposure received in an emergency exposure situation by an emergency worker;

"emergency response plan" means arrangements to plan for adequate response in the event of an emergency exposure situation on the basis of postulated events and related scenarios;

"emergency worker" means any person having a defined role in an emergency and who might be exposed to radiation while taking action in response to the emergency;

"environmental monitoring" means the measurement of external dose rates due to radioactive substances in the environment or of concentrations of radionuclides in environmental media;

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

,

where

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

The values for wR are specified in Annex II, Part A. The unit for equivalent dose is the sievert (Sv);

"exemption level" means a value established by a competent authority or in legislation and expressed in terms of activity concentration or total activity at or below which a radiation source is not subject to notification or authorisation;

"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;

"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;

"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);

"extremities" means the hands, forearms, feet and ankles;

"health detriment" means reduction in length and quality of life occurring in a population following exposure, including those arising from tissue reactions, cancer and severe genetic disorder;

"health screening" means a procedure using medical radiological installations for early diagnosis in population groups at risk;

"high-activity sealed source" means a sealed source for which the activity of the contained radionuclide is equal to or exceeds the relevant activity value laid down in Annex III;

"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;

"inspection" means an investigation by or on behalf of any competent authority to verify compliance with national legal requirements;

"intake" means the total activity of a radionuclide entering the body from the external environment;

"interventional radiology" means the use of X-ray imaging techniques to facilitate the introduction and guidance of devices in the body for diagnostic or treatment purposes;

"ionising radiation" means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly;

"licence" means permission granted in a document by the competent authority to carry out a practice in accordance with specific conditions laid down in that document;

"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, as well as exposure incurred by carers and comforters and by volunteers in medical or biomedical research;

"medical physics expert" means an individual or, if provided for in national legislation, a group of individuals, having the knowledge, training and experience to act or give advice on matters relating to radiation physics applied to medical exposure, whose competence in this respect is recognised by the competent authority;

"medical radiological" means pertaining to radiodiagnostic and radiotherapeutic procedures, and interventional radiology or other medical uses of ionising radiation for planning, guiding and verification purposes;

"medical radiological installation" means a facility where medical radiological procedures are performed;

"medical radiological procedure" means any procedure giving rise to medical exposure;

"members of the public" means individuals who may be subject to public exposure;

"natural radiation source" means a source of ionising radiation of natural, terrestrial or cosmic origin;

"non-medical imaging exposure" means any deliberate exposure of humans for imaging purposes where the primary intention of the exposure is not to bring a health benefit to the individual being exposed;

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

"notification" means submission of information to the competent authority to notify the intention to carry out a practice within the scope of this Directive;

"occupational exposure" means exposure of workers, apprentices and students, incurred in the course of their work;

"occupational health service" means a health professional or body competent to perform medical surveillance of exposed workers and whose capacity to act in that respect is recognised by the competent authority;

"orphan source" means a radioactive 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;

"outside worker" means any exposed worker who is not employed by the undertaking responsible for the supervised and controlled areas, but performs activities in those areas, including, apprentices and students;

"planned exposure situation" means an exposure situation that arises from the planned operation of a radiation source or from a human activity which alters 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.

"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;

"practical aspects of medical radiological procedures" means the physical conduct of a medical exposure and any supporting aspects, including handling and use of medical radiological equipment, the assessment of technical and physical parameters (including radiation doses), calibration and maintenance of equipment, preparation and administration of radio-pharmaceuticals, and image processing;

"practice" means a human activity that can increase the exposure of individuals to radiation from a radiation source and is managed as a planned exposure situation;

"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;

"processing" means chemical or physical operations on radioactive material including the mining, conversion, enrichment of fissile or fertile nuclear material and the reprocessing of spent fuel;

"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;

"public exposure" means exposure of individuals, excluding any occupational or medical exposure;

"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;

"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;

"radiation generator" means a device capable of generating ionising radiation, such as X-rays, neutrons, electrons or other charged particles;

"radiation protection expert" means an individual or, if provided for in the national legislation, a group of individuals having the knowledge, training and experience needed to give radiation protection advice in order to ensure the effective protection of individuals, and whose competence in this respect is recognised by the competent authority;

"radiation protection officer" means an individual who is technically competent in radiation protection matters relevant for a given type of practice to supervise or perform the implementation of the radiation protection arrangements;

"radiation source" means an entity that may cause exposure, such as by emitting ionising radiation or by releasing radioactive material;

"radioactive material" means material incorporating radioactive substances;

"radioactive source" means a radiation source incorporating radioactive material for the purpose of utilising its radioactivity;

"radioactive substance" means any substance that contains one or more radionuclides the activity or activity concentration of which cannot be disregarded from a radiation protection point of view;

"radioactive waste" means radioactive material in gaseous, liquid or solid form for which no further use is foreseen or considered by the Member State or by a legal or natural person whose decision is accepted by the Member State, and which is regulated as radioactive waste by a competent regulatory authority under the legislative and regulatory framework of the Member State;

"radiodiagnostic" means pertaining to in-vivo diagnostic nuclear medicine, medical diagnostic radiology using ionising radiation, and dental radiology;

"radiotherapeutic" means pertaining to radiotherapy, including nuclear medicine for therapeutic purposes;

"radon" means the radionuclide Rn-222 and its progeny, as appropriate;

"exposure to radon" means exposure to radon progeny;

"reference level" means in an emergency exposure situation or in an existing exposure situation, the level of effective dose or equivalent dose or activity concentration above which it is judged inappropriate to allow exposures to occur as a result of that exposure situation, even though it is not a limit that may not be exceeded;

"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;

"registration" means permission granted in a document by the competent authority, or granted by national legislation, through a simplified procedure, to carry out a practice in accordance with conditions laid down in national legislation or specified by a competent authority for this type or class of practice;

"regulatory control" means any form of control or regulation applied to human activities for the enforcement of radiation protection requirements;

"remedial measures" means the removal of a radiation source or the reduction of its magnitude (in terms of activity or amount) or the interruption of exposure pathways or the reduction of their impact for the purposes of avoiding or reducing doses that might otherwise be received in an existing exposure situation;

"representative person" means an individual receiving a dose that is representative of the more highly exposed individuals in the population, excluding those individuals having extreme or rare habits;

"sealed source" means a radioactive source in which the radioactive material is permanently sealed in a capsule or incorporated in a solid form with the objective of preventing, under normal conditions of use, any dispersion of radioactive substances;

"sievert" (Sv) is the special name of the unit of equivalent or effective dose. One sievert is equivalent to one joule per kilogram:

;

"storage" means the holding of radioactive material, including spent fuel, a radioactive source or radioactive waste, in a facility with the intention of retrieval;

"supervised area" means an area subject to supervision for the purpose of protection against ionising radiation;

"source container" means an assembly of components intended to guarantee the containment of a sealed source, where it is not an integral part of the source but is meant for shielding the source during its transport and handling;

"spacecraft" means a manned vehicle designed to operate at an altitude of more than 100 km above sea level;

"standard values and relationships" means values and relationships recommended in chapters 4 and 5 of ICRP Publication 116 for the estimation of doses from external exposure and chapter 1 of ICRP Publication 119 for the estimation of doses from internal exposure, including updates approved by Member States. Member State may approve the use of specific methods in specified cases relating to the physico-chemical properties of the radionuclide or other features of the exposure situation or of the exposed individual;

"thoron" means the radionuclide Rn-220 and its progeny, as appropriate;

"undertaking" means a natural or legal person who has legal responsibility under national law for carrying out a practice, or for a radiation source (including cases where the owner or holder of a radiation source does not conduct related human activities);

"unintended exposure" means medical exposure that is significantly different from the medical exposure intended for a given purpose.

Justification: Decisions introducing a practice 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 the practice outweighs the health detriment that it may cause. Decisions introducing or altering an exposure pathway for existing and emergency exposure situations shall be justified in the sense that they should do more good than harm.

Optimisation: Radiation protection of individuals subject to public or occupational exposure shall be optimised with the aim of keeping the magnitude of individual doses, the likelihood of exposure and the number of individuals exposed as low as reasonably achievable taking into account the current state of technical knowledge and economic and societal factors. The optimisation of the protection of individuals subject to medical exposure shall apply to the magnitude of individual doses and be consistent with the medical purpose of the exposure, as described in Article 56. This principle shall be applied not only in terms of effective dose but also, where appropriate, in terms of equivalent doses, as a precautionary measure to allow for uncertainties as to health detriment below the threshold for tissue reactions.

Dose limitation: In planned exposure situations, the sum of doses to an individual shall not exceed the dose limits laid down for occupational exposure or public exposure. Dose limits shall not apply to medical exposures.

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 authority. In the case of outside workers the dose constraint shall be established in cooperation between the employer and the undertaking.

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 authority shall ensure that the constraints are consistent with the dose limit for the sum of doses to the same individual from all authorised practices.

for medical exposure, dose constraints shall apply only with regard to the protection of carers and comforters and volunteers participating in medical or biomedical research.

the limit on the equivalent dose for the lens of the eye shall be 20 mSv in a single year or 100 mSv in any five consecutive years subject to a maximum dose of 50 mSv in a single year, as specified in national legislation.

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;

the limit on the equivalent dose for the extremities shall be 500 mSv in a year.

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

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;

the limit on the equivalent dose for the extremities shall be 150 mSv in a year.

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

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.

the radiation health risks involved in their work;

the general radiation protection procedures and precautions to be taken;

the radiation protection procedures and precautions 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;

the relevant parts of the emergency response plans and procedures;

the importance of complying with the technical, medical and administrative requirements.

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

informed of basic facts about ionising radiation and its effects;

informed of and trained in the actions to be taken on site in the event of the detection or suspected detection of a source.

all types of practices involving non-medical imaging exposure shall be justified before being generally accepted;

each particular application of a generally accepted type of practice shall be justified;

all individual non-medical imaging exposure procedures 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;

the general and particular justification of practices involving non-medical imaging exposure, as specified in (a) and (b), may be subject to review;

circumstances warranting non-medical imaging exposures, without individual justification of each exposure, shall be subject to regular review.

the practice is subject to authorisation;

requirements for the practice, including criteria for individual implementation, are established by the competent authority, in cooperation with other relevant bodies and medical scientific societies, as appropriate;

for procedures using medical radiological equipment

for procedures not using medical radiological equipment, dose constraints are significantly below the dose limit for members of the public;

information is provided to and consent sought from the individual to be exposed, allowing for cases where the law enforcement authorities may proceed without consent of the individual according to national legislation;

radioactive materials where the quantities of the activity involved do not exceed in total the exemption values set out in Table B, column 3, of Annex VII, or higher values that, for specific applications, are approved by the competent authority and satisfy the general exemption and clearance criteria set out in Annex VII; or

without prejudice to Article 25(4), radioactive materials where the activity concentrations do not exceed the exemption values set out in Table A of Annex VII, or higher values that, for specific applications, are approved by the competent authority and satisfy the general exemption and clearance criteria set out in Annex VII; or

apparatus containing a sealed source, provided that:

any electrical apparatus provided that:

the operation of radiation generators or accelerators or radioactive sources for medical exposures or for non-medical imaging purposes;

the operation of radiation generators or accelerators, except electron microscopes, or radioactive sources for purposes not covered by point (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;

the operation and decommissioning of any nuclear facility and the exploitation and closure of uranium mines;

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

any practice involving a high-activity sealed source;

the operation, decommissioning and closure of any facility for the long term storage or disposal of radioactive waste, including facilities managing radioactive waste for this purpose;

practices discharging significant amounts of radioactive material with airborne or liquid effluent into the environment.

for solid material do not exceed the clearance levels set out in Table A of Annex VII; or

comply with specific clearance levels and associated requirements for specific materials or for materials originating from specific types of practices; these specific clearance levels shall be established in national legislation or by the national competent authority, following the general exemption and clearance criteria set out in Annex VII, and taking into account technical guidance provided by the Community.

emergency workers;

workers involved in the remediation of contaminated land, buildings and other constructions;

workers who are exposed to radon at work, in the situation specified in Article 54(3).

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

optimisation of radiation protection in all working conditions, including occupational exposures as a consequence of practices involving medical exposures;

classification of exposed workers into different categories;

control measures and monitoring relating to the different areas and working conditions, including, where necessary, individual monitoring;

medical surveillance;

education and training.

the examination and testing of protective devices and measuring instruments;

prior critical review of plans for installations from the point of view of radiation protection;

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

regular checking of the effectiveness of protective devices and techniques;

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

to assess the exposure of the crew concerned;

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

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

to apply Article 10(1) to pregnant air crew.

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, where appropriate, in the adjacent area.

Taking into account the nature and extent of radiological risks in the controlled area, radiological surveillance of the workplace shall be organised in accordance with the provisions of Article 39.

Signs indicating the type of area, the nature of the sources and their inherent risks shall be displayed.

Working instructions appropriate to the radiological risk associated with the sources and the operations involved shall be laid down.

The worker shall receive specific training in connection with the characteristics of the workplace and the activities.

The worker shall be provided with the appropriate personal protective equipment.

taking into account the nature and extent of radiological risks in the supervised area, radiological surveillance of the workplace shall be organised in accordance with the provisions of Article 39;

if appropriate, signs indicating the type of area, the nature of the sources and their inherent risks shall be displayed;

if appropriate, working instructions appropriate to the radiological risk associated with the sources and the operations involved shall be laid down.

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

the measurement of the activity concentration in air and the surface density of contaminating radionuclides, indicating their nature and their physical and chemical states.

category A: those 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;

category B: those exposed workers who are not classified as category A workers.

a record of the exposures measured or estimated, as the case may be, of individual doses pursuant to Articles 41, 42, 51, 52, 53 and, if decided by the Member State pursuant to Article 35(2), 54(3);

in the case of exposures as referred to in Articles 42, 52 and 53, the reports relating to the circumstances and the action taken;

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

made available to the competent authority, to the undertaking, and to the employer of outside workers;

made available to the worker concerned in accordance with paragraph 2;

submitted to the occupational health service in order for it to interpret the implications of the results for human health, as provided for in Article 45(2);

submitted to the data system for individual radiological monitoring established by the Member State in accordance with provisions set out in Annex X.

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;

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

fit;

fit, subject to certain conditions;

unfit.

for category A workers entering controlled areas, check that the outside worker concerned has been passed as medically fit for the activities to be assigned to the worker;

check whether the categorisation of the outside worker is appropriate in relation to the doses liable to be received within the undertaking;

for entry into controlled areas, ensure that, in addition to the basic training in radiation protection the outside worker has received specific instructions and training in connection with the characteristics of the workplace and the conducted activities, in accordance with points (c) and (d) of Article 15(1);

for entry into supervised areas, ensure that the outside worker has received working instructions appropriate to the radiological risk associated with the sources and the operations involved, as required in point (c) of Article 38(1);

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

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;

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

for entry into controlled areas, ensure or take all appropriate steps to ensure that after every activity the radiological data from individual exposure monitoring of each category A outside worker within the meaning of Annex X, Section B, point 2, are recorded.

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

ensuring that the information and training in the field of radiation protection referred to in points (a), (b) and (e) of Article 15(1), Article 15(2), (3) and (4) is provided.

guaranteeing that their workers are subject to appropriate assessment of exposure and, for category A workers, medical surveillance, under the conditions laid down in Articles 39 and 41 to 49;

ensuring that the radiological data from the individual exposure monitoring of each of their category A workers within the meaning of Annex X, Section B, point 1, are kept up to date in the data system for individual radiological monitoring referred to in point (d) of Article 44(1).

only category A workers as defined in Article 40 or spacecraft crew may be subject to such exposures;

apprentices, students, pregnant workers, and, if there is a risk of intake or bodily contamination, breastfeeding workers, are excluded from such exposures;

the undertaking justifies such exposures in advance and thoroughly discuss them with the workers, their representatives, the occupational health service and the radiation protection expert;

information about the risks involved and the precautions to be taken during the operation are provided to the relevant workers in advance;

the workers have consented;

all doses relating to such exposures are separately recorded in the medical record referred to in Article 48 and the individual record referred to in Article 43.

reference levels for emergency occupational exposure shall be set, in general below an effective dose of 100 mSv;

in exceptional situations, in order to save life, prevent severe radiation-induced health effects, or prevent the development of catastrophic conditions, a reference level for an effective dose from external radiation of emergency workers may be set above 100 mSv, but not exceeding 500 mSv.

in workplaces within the areas identified in accordance with Article 103(3), that are located on the ground floor or basement level, taking into account parameters contained in the national action plan as under point 2 of Annex XVIII, as well as

in specific types of workplaces identified in the national action plan taking into account point 3 of Annex XVIII.

new types of practices involving medical exposure are justified in advance before being generally adopted;

all individual medical exposures are 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 medical exposure is not justified in general, a specific individual exposure of this type can be justified, where appropriate, in special circumstances, to be evaluated on a case-by-case basis and documented.

the referrer and the practitioner, as specified by Member States, seek, where practicable, to obtain previous diagnostic information or medical records relevant to the planned exposure and consider these data to avoid unnecessary exposure.

medical exposure for medical or biomedical research are examined by an ethics committee, set up in accordance with national procedures and/or by the competent authority;

specific justification for medical radiological procedures to be performed as part of a health screening programme are carried out by the competent authority in conjunction with appropriate medical scientific societies or relevant bodies.

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

any medical radiological procedure on an asymptomatic individual, to be performed for the early detection of disease, is part of a health screening programme, or requires specific documented justification for that individual by the practitioner, in consultation with the referrer, following guidelines from relevant medical scientific societies and the competent authority. Special attention shall be given to the provision of information to the individual subject to medical exposure, as required by point (d) of Article 57(1).

the individuals concerned participate voluntarily;

these individuals are informed about the risks of exposure;

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

in the case of patients who voluntarily accept to undergo an experimental medical 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 prior to the exposure taking place.

dose constraints are established for the exposure of carers and comforters, where appropriate;

appropriate guidance is established for the exposure of carers and comforters.

any medical exposure takes place under the clinical responsibility of a practitioner;

the practitioner, the medical physics expert and those entitled to carry out practical aspects of medical radiological procedures are involved, as specified by Member States, in the optimisation process;

the referrer and the practitioner are involved, as specified by Member States, in the justification process of individual medical exposures;

wherever practicable and prior to the exposure taking place, the practitioner or the referrer, as specified by Member States, ensures that the patient or their representative is provided with adequate information relating to the benefits and risks associated with the radiation dose from the medical exposure. Similar information as well as relevant guidance shall be given to carers and comforters, in accordance with point (b) of Article 56(5).

written protocols for every type of standard medical radiological procedure are established for each equipment for relevant categories of patients;

information relating to patient exposure forms part of the report of the medical radiological procedure;

referral guidelines for medical imaging, taking into account the radiation doses, are available to the referrers;

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

clinical audits are carried out in accordance with national procedures;

appropriate local reviews are undertaken whenever diagnostic reference levels are consistently exceeded and that appropriate corrective action is taken without undue delay.

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

an up-to-date inventory of medical radiological equipment for each medical radiological installation is available to the competent authority;

appropriate quality assurance programmes and assessment of dose or verification of administered activity are implemented by the undertaking; and

acceptance testing 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 maintenance procedure liable to affect the performance.

the use of fluoroscopy equipment without a device to automatically control the dose rate, or without an image intensifier or equivalent device, is prohibited.

equipment used for external beam radiotherapy with a nominal beam energy exceeding 1 MeV has a device to verify key treatment parameters. Equipment installed prior to 6 February 2018 may be exempted from this requirement.

any equipment used for interventional radiology has a device or a feature informing the practitioner and those carrying out practical aspects of the medical procedures of quantity of radiation produced by the equipment during the procedure. Equipment installed prior to 6 February 2018 may be exempted from this requirement.

any equipment used for interventional radiology and computed tomography and any new equipment used for planning, guiding and verification purposes has a device or a feature informing the practitioner, at the end of the procedure, of relevant parameters for assessing the patient dose.

equipment used for interventional radiology and computed tomography has the capacity to transfer the information required under 3(d) to the record of the examination. Equipment installed prior to 6 February 2018 may be exempted from this requirement.

without prejudice to points (c), (d) and (e) of paragraph 3, new medical radiodiagnostic equipment producing ionising radiation has a device, or an equivalent means, informing the practitioner of relevant parameters for assessing the patient dose. Where appropriate, the equipment shall have the capacity to transfer this information to the record of the examination.

of children;

as part of a health screening programme;

involving high doses to the patient, which may be the case in interventional radiology, nuclear medicine, computed tomography or radiotherapy.

all reasonable measures are taken to minimise the probability and magnitude of accidental or unintended exposures of individuals subject to medical exposure;

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

for all medical exposures the undertaking implements an appropriate system for the record keeping and analysis of events involving or potentially involving accidental or unintended medical exposures, commensurate with the radiological risk posed by the practice;

arrangements are made to inform the referrer and the practitioner, and the patient, or their representative, about clinically significant unintended or accidental exposures and the results of the analysis;

mechanisms are in place for the timely dissemination of information, relevant to radiation protection in medical exposure, regarding lessons learned from significant events.

examination and approval of the proposed siting of the facility from a radiation protection point of view, taking into account relevant demographic, meteorological, geological, hydrological and ecological conditions;

acceptance into service of the facility subject to adequate protection being provided against any exposure or radioactive contamination liable to extend beyond the perimeter of the facility or radioactive contamination liable to extend to the ground beneath the facility;

examination and approval of plans for the discharge of radioactive effluents;

measures to control the access of members of the public to the facility.

take into account the results of the optimisation of radiation protection;

reflect good practice in the operation of similar facilities.

decide on a reasonable extent of surveys to be conducted and information to be taken into account in order to identify the representative person, taking into account the effective pathways for transmission of the radioactive substances;

decide on a reasonable frequency of monitoring of the relevant parameters as determined in point (a);

ensure that the estimates of doses to the representative person include:

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

achieve and maintain an optimal level of protection of members of the public;

accept into service adequate equipment and procedures for measuring and assessing exposure of members of the public and radioactive contamination of the environment;

check the effectiveness and maintenance of equipment as referred to in point (b) and ensure the regular calibration of measuring instruments;

seek advice from a radiation protection expert in the performance of the tasks referred to in points (a), (b) and (c).

the radiation source, to reduce or stop the radiation, including the release of radionuclides;

the environment, to reduce the exposure to individuals resulting from radioactive substances through relevant pathways;

individuals, to reduce their exposure.

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 Section B of Annex XI;

the assessment and recording of the consequences of the emergency and of the effectiveness of the protective measures.

objectives, including long-term goals pursued by the strategy and corresponding reference levels, in accordance with Article 7;

delineation of the affected areas and identification of the affected members of the public;

consideration of the need for and extent of protective measures to be applied to the affected areas and members of the public;

consideration of the need to prevent or control access to the affected areas, or to impose restrictions on living conditions in these areas;

assessment of the exposure of different groups in the population and assessment of the means available to individuals for controlling their own exposure.

establishment of appropriate reference levels;

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

if appropriate, remediation measures;

if appropriate, delineated areas.

the activity concentrations of the radionuclides specified in Annex VIII are determined, and that,

information to the competent authority on the results of measurements and the corresponding activity concentration index, as well as other relevant factors, as defined in Annex VIII, are provided if requested.

is functionally separate from any other body or organisation concerned with the promotion or utilisation of practices under this Directive, in order to ensure effective independence from undue influence on its regulatory function;

is given the legal powers and human and financial resources necessary to fulfil its obligations.

occupational health services;

dosimetry services;

radiation protection experts;

medical physics experts.

optimisation and establishment of appropriate dose constraints;

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;

categorisation of controlled and supervised areas;

classification of workers;

workplace and individual monitoring programmes and related personal dosimetry;

appropriate radiation monitoring instrumentation;

quality assurance;

environmental monitoring programme;

arrangements for radioactive waste management;

arrangements for prevention of accidents and incidents;

preparedness and response in emergency exposure situations;

training and retraining programmes for exposed workers;

investigation and analysis of accidents and incidents and appropriate remedial actions;

employment conditions for pregnant and breastfeeding workers;

preparation of appropriate documentation such as prior risk assessments and written procedures;

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

the definition and performance of quality assurance of the medical radiological equipment;

acceptance testing of medical radiological equipment;

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

the surveillance of the medical radiological installations;

the analysis of events involving, or potentially involving, accidental or unintended medical exposures;

the selection of equipment required to perform radiation protection measurements;

the training of practitioners and other staff in relevant aspects of radiation protection;

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

supervise implementation of the programme for workplace monitoring;

maintaining adequate records of all radiation sources;

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

supervise implementation of the personal monitoring programme;

supervise implementation of the health surveillance programme;

providing new workers with an appropriate introduction to local rules and procedures;

giving advice and comments on work plans;

establishing work plans;

providing reports to the local management;

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

information and training of exposed workers;

liaising with the radiation protection expert.

adequate arrangements have been made for the safe management and control 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;

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.

responsibilities;

minimum staff competencies, including information and training;

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

requirements for emergency procedures and communication links;

work procedures to be followed;

maintenance of equipment, sources and containers;

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.

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

at intervals to be determined by Member States;

if the situation indicated on the information sheet has changed;

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 or storage facility to which the source is transferred shall be included;

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

raising general awareness of the possible occurrence of orphan sources and associated hazards; and

issuing guidance for persons who suspect or have knowledge of the presence of an orphan source on informing the competent authority and on the actions to be taken.

implement, as appropriate, a recording and analysis system of significant events involving or potentially involving accidental or unintended exposures;

promptly notify the competent authority of 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 authorising requirements with regard to occupational or public exposure or as defined by the competent authority for medical exposure, including the results of the investigation and the corrective measures to avoid such events.

the objectives pursued;

appropriate reference levels, taking into account the reference levels laid down in Annex I.

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

provide information to exposed populations on the potential health risks and on the available means for reducing their exposure;

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

with regard to activities that involve naturally occurring radioactive material and are not managed as planned exposure situations, provide information on appropriate means for monitoring concentrations and exposures and for taking protective measures.

1.

Without prejudice to reference levels set for equivalent 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 (acute or annual) for emergency exposure situations.

2.

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

3.

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.

4.

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

A.

Any undertaking intending to manufacture or import into a Member State consumer products for which the intended use is likely to lead to a new class or type of practice, shall provide the competent authority of this Member State with all relevant information, as to the:

B.

The competent authority shall examine that information and in particular assess whether:

Radiological health assessment for employment purposes;

Radiological health assessment for immigration purposes;

Radiological health assessment for insurance purposes;

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

Radiological age assessment;

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

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

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

Practices involving the use of ionising radiation for legal or security purposes.

Extraction of rare earths from monazite

Production of thorium compounds and manufacture of thorium-containing products

Processing of niobium/tantalum ore

Oil and gas production

Geothermal energy production

TiO2 pigment production

Thermal phosphorus production

Zircon and zirconium industry

Production of phosphate fertilisers

Cement production, maintenance of clinker ovens

Coal-fired power plants, maintenance of boilers

Phosphoric acid production,

Primary iron production,

Tin/lead/copper smelting,

Ground water filtration facilities,

Mining of ores other than uranium ore.

(a)

The total activity values (in 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.

(b)

The exempt activity concentration values (in kBq kg-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 A, 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.

(c)

The concentration values in Table A, Part 1, or in Table A, Part 2, also apply to the clearance of solid materials for reuse, 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.

(d)

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 higher values taking Community guidance into account.

(e)

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. For this purpose, compliance with the provisions of Article 75 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 competent 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.

(a)

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

(b)

Practices involving small amounts of radioactive substances or low activity concentrations, comparable to the exemption values laid down in Table A or Table B are deemed to fulfil criterion (iii).

(c)

Practices involving amounts of radioactive substances or activity concentrations below the exemption values laid down in Table A, Part 1, or Table B, are deemed to comply with criterion (i) 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.

(d)

In the case of moderate amounts of material, as specified by Member States for specific types of practice, the activity concentration values laid down in Table B, column 2, may be used instead of the values laid down in Table A, Part 1, for the purpose of exemption from authorisation.

(e)

For the purpose of exemption from notification or for the purpose of clearance, where amounts of radioactive substances or activity concentrations do not comply with the values laid down in Table A or Table B, an assessment shall be made in the light of the general criteria (i) to (iii) above. For compliance with the general criterion (i), it shall be demonstrated that workers should not be classified as exposed workers, and the following criteria for the exposure of members of the public are met in all feasible circumstances:

For the purpose of exemption from authorisation, less restrictive dose criteria may be applied.