FP7_TA(2013)0452

Dangers arising from exposure to ionising radiation ***I

European Parliament legislative resolution of 24 October 2013 on the proposal for a Council directive laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation (COM(2012)0242 — C7-0151/2012 — 2011/0254(COD))

(Ordinary legislative procedure: first reading)

(2016/C 208/30)

The European Parliament,

having regard to the Commission proposal to the Council (COM(2012)0242),

having regard to Articles 31 and 32 of the Euratom Treaty pursuant to which the Council consulted Parliament (C7-0151/2012),

having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis,

having regard to Article 294(3) and Article 192(1) of the Treaty on the Functioning of the European Union,

having regard to the opinion of the European Economic and Social Committee of 22 February 2012 (1) ,

having regard to Rules 55 and 37 of its Rules of Procedure,

having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on Employment and Social Affairs (A7-0303/2013),

Calls on the Commission to alter its proposal accordingly, pursuant to Article 293(2) of the Treaty on the Functioning of the European Union;

Calls on the Commission to notify the Parliament how Parliament's position has been taken into due account;

Instructs its President to forward its position to the Council and the Commission.

(1) OJ C 143, 22.5.2012, p. 113.

P7_TC1-COD(2011)0254

Position of the European Parliament adopted at first reading on 24 October 2013 with a view to the adoption of Directive 2013/…/EU of the European Parliament and of the Council laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Atomic Energy Community on the Functioning of the European Union , and in particular Articles 31 and 32 Article 192(1) thereof, [Am. 1]

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,

After transmission of the draft legislative act to the national parliaments,

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

Acting in accordance with the ordinary legislative procedure, (1) ,

Whereas:

(1) Article 2(b) 191 of the Treaty on the Functioning of the European Union (TFEU) 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 the legal basis for preserving, protecting and improving the quality of the environment and protecting human health protection of workers and the general public , including against the dangers arising from exposure to ionising radiations radiation . [Am. 2] (1a) Article 153 TFEU allows for the establishment of safety standards to protect the health of workers and of the general public. [Am. 3] (1b) Article 168 TFEU allows for the establishment of basic standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation. [Am. 4]

(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 (2). The Directives have been revised several times, most recently in 1996 by Council Directive 96/29/Euratom (3) 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 (4), Council Directive 89/618/Euratom (5), Council Directive 90/641/Euratom (6) and Council Directive 2003/122/Euratom (7) 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) (8), 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. With regard to the application of the standards and requirements, however, it should also draw a distinction between existing exposure situations attributable to natural radiation and existing anthropic 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. [Am. 5]

(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 natural radioactivity in building materials should allow for the free circulation of building materials while at the same time improving protection against radiological risks . [Am. 6]

(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 (9) 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 has consequences for the health of the general public . 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. As organisms are susceptible to both internal and external radiation, more resources should be devoted to examining in detail the impact that ionising radiation has on both humankind and the environment. [Am. 8]

(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 (10) 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 (11).

(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 (12) 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 and transparency between Member States in emergency planning and response. [Am. 9]

(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 and appropriate penalties should be introduced for the issuing discharge authorisations and for the monitoring of discharges. Commission Recommendation 2004/2/Euratom (13) introduced standardised information for the reporting of data on discharges from nuclear power plants and reprocessing facilities. [Am. 10]

(31) No major changes need to be made to the most recent Directive 2003/122/Euratom, except to broaden some of should be broadened with regard to the requirements in order to include any sealed radioactive source. However, there are still unresolved problems with orphan sources , for example unexploded munitions 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. [Am. 11]

(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,

HAVE 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 guaranteeing a uniform threshold level of protection in the Member States without barring Member States from maintaining or establishing higher basic safety standards than set out in this Directive . [Ams. 12 and 133]

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 mandatory information in an emergency exposure situation. [Am. 13]

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 , accidental 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. [Am. 14]

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 and temporary or final radioactive waste storage ; [Am. 15]

(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) practices exposing workers to cosmic radiation, including the operation of aircraft and spacecraft as well as frequent flying ; [Am. 16] (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 resulting from an accident, malfunction, malicious act or conflict or from any other non-routine 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; [Am. 17]

(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 any material in a liquid, gaseous or solid form incorporating radioactive substances; [Am. 18]

(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 possible ; [Am. 19]

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

(24) Occupational exposure means exposure of workers , including employees and self-employed people as well as trainees and volunteers, incurred in the course of their work; [Am. 20]

(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 The definition used in ICRP Publication 103 delimits detriment as loss arising from tissue effects, cancer and severe genetic disorder (equivalent to a terminal illness) ; [Am. 21]

(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, including a trainee or volunteer, 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; [Am. 22]

(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 aged 16 years or over (including trainees and students) receiving training or instruction within an undertaking with a view to exercising a specific skill , which involves operations which would, in the case of an employee, be considered as working with ionising radiation . [Am. 23]

(39) Committed effective dose (E(τ)) means 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), 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, τ 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;

(42a) Competent authority means any authority designated by a Member State. [Am. 24]

(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 status affords a guarantee of independence from the employer of the exposed workers and whose capacity to act in this respect is recognised by the competent authorities; [Am. 25]

(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 and of total activity , at or below which materials arising from any practice subject to notification or authorisation may be released from the requirements of this Directive. [Am. 26]

(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) Highly 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; [Am. 27]

(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; [Am. 28]

(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 or liable to receive a dose that is representative of the more highly exposed individuals in the population . Evaluations shall take account of scenarios that are worse than the existing conditions unless it is demonstrated that such scenarios are not liable to arise or that their emergence would be identified and would trigger re-evaluation of the dosimetric impact ; [Am. 30]

(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 , and whose capacity to act is recognised by the competent authorities ; [Am. 31]

(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; [Am. 32]

(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(τ)) means the integral over time (τ) 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, τ is the time over which the integration is performed. In specifying HT(τ), τ is given in years. When τ 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 in normal situations 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; [Am. 33]

(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 up-to-date, robust scientific evidence, following principles of justification, optimisation and, dose limitation and reparation of damages : [Am. 34]

(a) justification: decisions introducing or altering a radiation source, an exposure pathway or actual exposures which increase individuals’ exposure to ionising radiation 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; [Am. 35]

(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 possible , 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; [Am. 36]

(c) dose limitation: in planned exposure situations, the sum of doses received by a member of the public from all regulated radiation sources and all existing anthropic exposure situations shall not exceed the dose limits laid down for public exposure. The sum of doses to an individual exposed worker 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. [Am. 37]

(ca) reparation for damages: before authorising the construction of a nuclear installation or renewing its operating licence, Member States shall establish a mechanism which guarantees reparation for all physical damage and personal injury likely to be caused by an emergency at the installation. [Am. 38] Information regarding justification and dose limitation shall be made available to the general public . [Am. 39]

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 in consultation with workers' representatives. Their decision shall be supervised by the competent authorities. In the case of outside workers the dose constraint shall be established in cooperation between the employer and the undertaking in consultation with workers' representatives . [Am. 40]

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 or as a result of an existing anthropic exposure situation . The competent authorities shall set the dose constraint so as to ensure the protection of health of the general public and compliance with the dose limit for the sum of doses to the same individual from all authorised practices , as well as from natural sources of radiation and residual contamination . The values chosen for the dose constraints shall be published, so that any member of the public can check that he or she has not received, as a result of aggregate planned and existing anthropic exposure situations, a dose in excess of the legal limit . [Am. 41]

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 to the lowest level below the reference levels which can reasonably be achieved . The values chosen for reference levels shall depend upon the type of exposure situation , the nature of the risk and the forms of intervention and protective and remedial measures available . [Am. 42]

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.

3a. Levels of intervention shall be laid down for the various countermeasures applicable in emergency exposure situations; they shall correspond to a level of effective dose or organ dose above which protective measures must be taken to limit the risk incurred by the persons exposed . [Am. 43]

4. The choice of reference levels for the effective dose shall take into account the three bands of The values corresponding to effective dose and equivalent organ dose set by the Member States for the reference and intervention levels set out in point 1 of Annex I shall be communicated to the Commission and published . Member States shall involve stakeholders in the process of setting these values . [Am. 44]

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 equivalent to 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. [Am. 45]

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 15 mSv in a year; [Am. 46]

(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. That limit shall be based on the aggregate doses received as a result of internal and external exposure linked to all regulated practices and existing anthropic exposure situations. [Am. 49]

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 continuous education, training and retraining to allow enable the recognition of radiation protection experts, medical physics experts, radiation protection officers, occupational health services, and dosimetry services , and to support the exchange of best practices between the Member States. All forms of education, training and up-to-date information shall enhance preparedness and enable swifter preventive and/or response actions in the field . [Am. 51]

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 , without exception, exposed workers, apprentices and students who are subject to occupational exposure about: [Am. 52]

(a) the health risks involved in their work;

(aa) safe working procedures to minimise risks; [Am. 53]

(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;

(da) the conditions under which workers are entitled to health surveillance; [Am. 54]

Where appropriate, information on the risks connected with frequent flying shall also be provided. [Am. 55]

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 and their containers as well as in how to report them ; [Am. 56]

(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 promptly given adequate complete 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. [Am. 57]

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.

5a. As regards Union citizens, the information requirements laid down in this Directive shall be met in one of the official languages of the Union in order that each citizen understands the information provided. [Am. 58]

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 and pre-tested before being approved , and are regularly checked during implementation . [Am. 59]

Member States shall ensure that all stakeholders, in particular the persons likely to be affected by the health impact of the practice, whether in normal operating circumstances or in an emergency, are involved in the decision-making process. That involvement shall be arranged sufficiently far ahead of the deadline for a decision so that alternative solutions can be properly studied. [Am. 60]

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 and/or where negative results have been registered . The Commission and the Member States shall lay down procedures for the revision of the justifications for existing practices at Union and national level. The arrangements shall in particular ensure that groups or individuals exposed to the dangers of ionising radiation as a result of these practices, and in particular members of the public and workers, can put forward proposals and take part in the decision-making process . [Am. 61]

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 in the country in which the undertaking has its registered office 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. [Am. 62]

2. The competent authority shall share the information received in accordance with paragraph 1 with the competent authorities of the other Member States in order to allow inform them to take their own of its decision on the justification of concerning the intended use of the apparatus or product. The competent authorities shall make that information available to all the other Member States. [Am. 63]

3. The undertaking shall be informed on the decisions of the Member States' competent authorities within a period of six four months. [Am. 64]

3a. In accordance with Article 22, this type of apparatus and products shall be intended for use in controlled environments. [Am. 65]

Article 22

Prohibition of practices

Member States shall prohibit and penalise the deliberate addition of radioactive substances in the production of foodstuffs, toys, personal ornaments and cosmetics , and, more generally, in consumer goods, 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 (14), practices involving the activation of material resulting in an increase in activity in the associated products shall be deemed not to be justified. [Am. 66]

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. They shall assess each year the individual and collective doses associated with each of the practices listed, their impact and their development over time. [Am. 67]

2. Member States shall monitor and ensure that special attention is given to the justification of practices involving non-medical imaging exposure, in particular: [Am. 68]

(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.

3a. Member States shall be responsible for researching, developing and implementing alternative technologies. [Am. 69]

Article 24

Identification of practices involving naturally occurring radioactive material

Member States shall ensure the identification and publication 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 , in particular, industrial sectors listed in Annex V. [Am. 70]

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.

2a. Member States shall specify the information which the undertaking is required to provide in order to enable the competent authority to assess the levels of exposure of members of the public and workers and the radiological risks, in normal and emergency situations. On that basis, and drawing, where appropriate, on the findings of additional investigations, the competent authority shall determine which administrative arrangements are applicable and what regulatory control resources are required. [Am. 71]

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 by the competent authority . [Am. 72]

2. Notified practices may be exempted from authorisation. [Am. 73]

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 quantifiable dose limit can be established for a practice, 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. Licensing should be requested where the authorisation is applied to the overall activities of an undertaking. [Am. 74]

2. Member States shall require licensing for undertakings performing the following activities, or, where appropriate in accordance with paragraph 1, registration for the following practices: [Am. 75]

(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; [Am. 76]

(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;

(aa) measures taken pursuant to this Directive; [Am. 78]

(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. Random controls by the authorities shall be put in place.

Medical devices which emit ionising radiation shall be dealt with in accordance with Council Directive 93/42/EEC (15) . The arrangements for the exchange of information provided for under that Directive shall be exhausted and other competent authorities shall be informed. [Am. 79]

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 or workers concerned; [Am. 80]

(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 50 mSv per year for skin and extremities; [Am. 81]

(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 should require individual monitoring and if necessary individual measurements, performed by a dosimetry service, for category B workers. [Am. 82]

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. Therecord referred to in paragraph 1 shall be submitted to the data system for individual radiological monitoring established by the Member State in accordance with Annex VIII. 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. [Am. 83]

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 in a timely manner 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. [Am. 84]

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.

3a. Examination of the workers will take place during working hours and without costs to them. [Am. 85]

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

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

2. Consultation and participation of workers and/or their representatives shall be regulated by Article 11 of Council Directive 89/391/EEC (16) . [Am. 86]

Article 50

Protection of outside workers

1. Member States shall ensure that the system for individual radiological monitoring affords outside workers equivalent protection and medical care to that for workers employed on a permanent basis by the undertaking. [Am. 87]

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