THE CROATIAN PARLIAMENT

Transcription

1 THE CROATIAN PARLIAMENT Pursuant to Article 88 of the Constitution of the Republic of Croatia, I hereby issue the DECISION PROMULGATING THE ACT ON RADIOLOGICAL AND NUCLEAR SAFETY I hereby promulgate the Act on Radiological and Nuclear Safety, passed by the Croatian Parliament at its session on 19 February 2010 Class: /10-01/23 Reg. No: / Zagreb, 24 February 2010 The President of the Republic of Croatia Ivo Josipović, m.p. A C T ON RADIOLOGICAL AND NUCLEAR SAFETY I GENERAL PROVISIONS Subject matter Article 1 This Act establishes measures for safety and protection against ionising radiation and measures for physical protection in performing nuclear activities and practices involving sources of ionising radiation, with the aim of ensuring adequate protection of individuals, society and the environment, in the present and in the future, from harmful effects of ionising radiation, and ensuring the safe performance of practices involving ionising radiation sources, nuclear activities, radioactive waste disposal and the physical protection of ionising radiation sources and nuclear facilities.

2 Exemption from the application of the Act Article 2 This Act does not apply to the natural level of ionising radiation of cosmic, Earth s crust or human origin, where not modified by the action of man, except in the case of work activities referred to in Article 9 of this Act. Definitions Article 3 For the purposes of this Act, the following definitions apply: Activity of radioactive source is the number of decays of radionuclides in the time interval. The unit of activity is the Becquerel (Bq). Absorbed dose is the amount of energy imparted by ionising radiation to the body mass unit. The physical unit used for expressing absorbed dose is the Gray (Gy). One Gray is equal to the ratio between the energy of ionising radiation amounting to one joule per mass kilogram. Practice involving ionising radiation sources (hereinafter: practice) is a human activity that can increase the exposure of individuals to radiation from an artificial source, or from a natural radiation source where natural radionuclides are processed for their radioactive, fissile or fertile properties, except in the case of an emergency exposure. Licence for use of ionising radiation sources is the decision by which the State Office for Radiological and Nuclear Safety authorises the licensee to use a particular source of ionising radiation. Effective dose is the computationally modified absorbed dose expressing the risk of exposure to ionising radiation taking into account the difference in biological effectiveness of different types of ionising radiation and difference in sensitivity of tissues and organs of the human body with regard to ionising radiation. The physical unit expressing effective dose is one Sievert (Sv). Fission means the splitting of an atomic nucleus into two roughly identical nuclei, which move at a high velocity after being split, emitting several fast neutrons and gamma radiation. Physical inventory means the sum total of all measured or estimated quantities of nuclear material in batches that is available at a given time within a particular material balance area. Physical protection means the measures for preventing unauthorised access or damage, loss, theft or unauthorised transfer of ionising radiation sources, nuclear material or specified equipment. INES scale means a categorisation of nuclear events, incidents and accidents as defined by the International Atomic Energy Agency. Interventions are systematic, pre-programmed measures reducing the existing level of exposure to ionising radiation or the likelihood of irradiation by ionising radiation resulting from an emergency event.

3 Intervention levels are levels of expected irradiation which could occur as the result of an emergency event or chronic exposure to ionising radiation in the environment, during which special protection measures are undertaken. Ionising radiation is the transfer of energy in the form of electromagnetic waves or particles capable of producing pairs of positively and negatively charged particles-ions directly or indirectly. Spent sealed radiation source is an enclosed radioactive source the activity of which is less than the minimum activity required for carrying out the practice for which it was originally designated. Spent nuclear fuel means nuclear fuel that has been irradiated in and permanently removed from a reactor core. Exposed worker is a worker who must occupy the area of exposure while carrying out a practice. Emergency is an event related to practices involving ionising radiation, nuclear activities or safety of nuclear installations induced by circumstances which are out of control, and the result of which is the exposure of exposed workers and the population to increased irradiation or radioactive contamination of the environment. Orphan source is a sealed radioactive source which is not under supervision within the meaning of this Act, regardless of whether it has ever been under supervision or because it has been abandoned, lost, transferred, stolen or is the object of unauthorised practice. Ionising radiation source is any apparatus, installation or substance producing or emitting ionising radiation, which is not excluded from application of this Act, also including nuclear material. Source material includes: a) uranium containing the mixture of isotopes occurring in nature, b) uranium depleted in the isotope 235, c) thorium, d) any of the foregoing in the form of a metal, alloy, chemical compound or concentrate, e) any other material containing one or more of the foregoing in a concentration determined by the state administration body competent for nuclear safety. The term source material does not refer to ores and ore residues. Beneficiary is a government body, a state administration body or a body of regional and local selfgovernment as well as a legal or natural person who does not need authorisation for carrying out a particular practice involving an ionising radiation source. Medical irradiation is the exposure to ionising radiation of a patient during application of the ionising radiation source for diagnostic or therapeutic purposes. Holder of the licence for practice involving ionising radiation sources (hereinafter: licensee) is the legal or natural person, a state administration body or a body of local and regional self-government which has been granted a licence for practice involving a source of ionising radiation.

4 Holder of the licence for performing a nuclear activity (hereinafter: licence holder) is the legal or natural person, state administration body or body of local and regional self-government which has been granted a licence for performing a nuclear activity. Nuclear accident means an event or series of events resulting from an emergency occurring at a nuclear facility, with a high level of danger that radioactivity will spread outside the controlled area. Nuclear safety means the achievement of proper operating conditions with the aim of preventing emergencies or mitigating the consequences of an emergency, with the aim of protecting workers, the general public and the environment from the harmful effects of ionizing radiation. Nuclear incident means an event or a series of events resulting from an emergency occurring at a nuclear facility, with a low level of danger that radioactivity will spread outside the controlled area. According to the INES scale, a nuclear incident can measure from level 1 to level 3. Nuclear activities are: a) the use of nuclear material for energy-related purposes (power reactor in nuclear power plant, nuclear heating plant and nuclear propulsion), b) the use of nuclear material for research purposes (research reactor), c) mining of nuclear material and processing of minerals (uranium and thorium mines with a mineral processing plant), d) producing and enriching nuclear fuel, e) processing spent fuel originating from the reactor, f) storing low level and medium level radioactive waste originating from the reactor in quantities requiring the application of nuclear safety and protection measures, g) disposing low level and medium level radioactive waste originating from the reactor in quantities requiring the application of nuclear safety and protection measures, h) storing spent fuel and other high level radioactive waste originating from the reactor, i) disposing spent fuel and other high level radioactive waste originating from the reactor, j) storing nuclear material of categories I and II pursuant to Annex II of the Convention on the Physical Protection of Nuclear Material, k) disposing nuclear material of categories I, II and III pursuant to Annex II of the Convention on the Physical Protection of Nuclear Material. Nuclear fuel cycle comprises all activities connected with the production of nuclear energy, including: finding raw materials and producing nuclear fuel, using nuclear fuel in a nuclear reactor, terminating the operation of a nuclear reactor and decommissioning it, disposing of radioactive waste originating from nuclear installations, and all research performed in connection with these activities. Nuclear material means source material or special fissile material covered by a system of controls and protective measures. Nuclear facility means a facility for the processing and enrichment of nuclear materials or fabrication of nuclear fuel; critical or sub-critical nuclear reactors; research reactors; nuclear power and thermal plants; facilities for storage, processing or disposal of nuclear fuel or high level radioactive waste; and facilities for storage, processing or disposal of low and medium radioactive

5 waste. A nuclear facility may include several nuclear facilities provided that they are functionally connected within the same geographic area and that they are operated by a single person. Enriched uranium means uranium enriched in the isotopes 235 or 233, that is, uranium containing isotopes 235 or 233, or both, in such an amount that the ratio of the sum of these isotopes to isotope 238 is greater than the ratio of isotope 235 to isotope 238 found in nature. Enrichment means the proportion of the combined weight of uranium-233 and uranium-235 to the weight of the given uranium in total. Waste disposal facility means a facility suitable for the disposal of radioactive waste or spent nuclear fuel. Landfilling of radioactive waste and spent sealed radioactive sources is the activity of controlled, permanent placement of radioactive waste and spent sealed radioactive sources in a landfill facility with no intention to once again engage the radioactive waste and spent sealed radioactive source in any practice involving radioactive substances. Landfilling also involves the process of authorised and controlled discharge of radioactive waste into the environment taking into account its subsequent dispersion. Licence for practice involving ionising radiation sources (hereinafter: licence for practice) is the decision issued to a legal or natural person, a state administration body or the bodies of local and regional self-government units by the State Office for Radiological and Nuclear Safety authorising the performance of a particular practice involving ionising radiation sources, excluding nuclear activities. Licence for performing a nuclear activity is the decision issued to a legal or natural person, a state administration body or the bodies of local and regional self-government units by the State Office for Radiological and Nuclear Safety authorising the performance of a nuclear activity. Depleted uranium means uranium containing a lower amount of the isotope uranium-235 than natural uranium, i.e. less than 0.72%. Open radioactive source is a radioactive source which is not a sealed radioactive source, and may appear in solid, liquid or gaseous state. Authorised expert for nuclear safety is the legal or natural person authorised by virtue of a decision issued by the State Office for Radiological and Nuclear Safety for carrying out particular professional tasks in the field of nuclear safety. Authorised technical service is the legal person authorised by virtue of a decision issued by the State Office for Radiological and Nuclear Safety for carrying out particular professional tasks involving protection against ionising radiation. Irradiation is exposure to ionising radiation. It may be external or internal, depending on whether the source of ionising radiation is located outside or within the body. Batch data means the total mass of each element of nuclear material, as well as the isotope composition in the case of plutonium and uranium.

6 Area of exposure is the area with the likelihood of exposure of an individual or group of persons to ionising radiation above the irradiation limit prescribed per member of the public. The area of exposure is divided into an area under supervision and an area under special supervision. Member of the public is a natural person, excluding exposed workers, apprentices and students during their working hours and education. Specified equipment means equipment and non-nuclear material, which are used in peaceful nuclear activities, but may also be employed to produce nuclear weapons. Special fissile material means material on which fission may be carried out, including: a) plutonium-239, b) uranium-233, c) uranium enriched in the isotopes 235 or 233, d) any other material containing one or more of the foregoing, e) other kinds of fissile material as determined by the State Office for Radiological and Nuclear Safety. Natural radioactive substance having properties modified by technological processes is a natural substance in which the concentration of particular radionuclides is modified by human intervention outside the nuclear fuel cycle so that the activity or concentration of radionuclide activity contained by such a radioactive substance exceeds the limit prescribed by the ordinance issued by the director of the State Office for Radiological and Nuclear Safety, subject to the approval of the minister competent for health. Radioactive waste or spent nuclear fuel producer is a legal or natural person craftsman, whose activity results in generation of radioactive waste or spent nuclear fuel. Radioactive substances are substances containing, among others, atoms with unstable nuclei, the decay of which produces ionising radiation. Radioactive source is a radioactive substance which is not exempted. Radioactive waste is waste matter resulting from carrying out a practice involving sources of ionising radiation, nuclear activity or during operation of a nuclear facility, regardless of the physical form or chemical properties, containing radioactive substances the activity, concentration or radiation of which exceeds the limit prescribed by the ordinance issued by the director of the State Office for Radiological and Nuclear Safety, subject to the approval of the minister competent for health. Radioactive contamination is the contamination of any material, area, environment or a member of the public by radioactive substances. As regards organisms, radioactive contamination also involves external contamination of skin and internal contamination regardless of the method of introducing radionuclides. Radiological safety includes measures aimed at reducing irradiation of an exposed worker or a member of the public, increasing operational safety when working with ionising radiation sources, preventing the circumstances which may cause an emergency and reducing the potential harmful impacts to a minimum.

7 Radionuclide is an atom with a characteristic number of protons and neutrons and an energy state of the nucleus having the feature of radioactivity, meaning not stable. Work activities are human activities not classified as practices involving ionising radiation sources, in the course of which increased irradiation of workers and the population may occur from natural sources of ionising radiation. Remediation means the removal of radioactive contamination, disposal of the radioactive source or undertaking of any other indispensable measure in order to reduce the damage to people and the environment or eliminate further threats, hazards or damages. Storage means a facility suitable for storing radioactive waste and spent sealed radioactive sources. Storage of radioactive waste and spent sealed radioactive sources is the activity of placing the radioactive waste and/or spent sealed radioactive sources in warehouses prior to or following conditioning or treatment, or prior to release from supervision, restitution to the manufacturer, export or landfill, that is, safekeeping in such a way so as to ensure its isolation with the intention of carrying out the activity in the future. Batch means a portion of nuclear material regarded as a unit for record-keeping purposes at a key measurement point, and whose composition and quantity are defined by a single set of specifications or measurements. Permanently exposed area means the area contaminated with radioactive materials to such extent that the removal of contamination would not be technically or financially justified. Sealed radioactive source is a radioactive source sealed in an impenetrable shell made of nonradioactive substance so that the radioactive substance cannot come into contact with the environment. Disposal of radioactive waste and spent nuclear fuel implies any administrative and operational procedures involved in the activity of treatment, conditioning, transport, storage and landfilling of radioactive waste and spent nuclear fuel and spent sealed radioactive sources. Material balance area means an area in which it is possible, at a given time (when necessary), to carry out a physical inventory of the nuclear material and to, at any time, determine the quantity of such material transferred into or out of the area. Council for Radiological and Nuclear Safety Article 4 (1) The Council for Radiological and Nuclear Safety (hereinafter: the Council), an advisory body of the Croatian Parliament, shall be established to provide assessment of the state of radiological and nuclear safety in the Republic of Croatia. (2) The Council shall carry out the following activities: a) give its opinion on proposed acts regulating radiological and nuclear safety, subordinate legislation to be adopted based on the provisions of this Act, as well as other subordinate legislation necessary for its implementation, b) submit proposals and opinions to the Croatian Parliament regarding:

8 the state of radiological and nuclear safety in the Republic of Croatia, the development strategy for nuclear safety, the organisation of nuclear and radiological safety in the Republic of Croatia, international cooperation in the area of nuclear and radiological safety, in particular accession to and implementation of international treaties in this area, other aspects of nuclear and radiological safety in the Republic of Croatia. (3) The Council shall have seven members, one of whom shall be its president. (4) The president and other members of the Council shall be appointed and dismissed from office by the Croatian Parliament, at the proposal of the Government of the Republic of Croatia. Members of the Council shall be chosen from among experts in the area of protection against ionising radiation and nuclear safety for a term of 4 years. (5) The vice-president of the Council shall be nominated by its president and chosen by a majority of Council members. (6) The Council s work shall be regulated by its rules of procedure. (7) Expert and technical work for the Council shall be performed by the State Office for Radiological and Nuclear Safety. Information to the public Article 5 (1) Information pertaining to carrying out practices involving ionising radiation sources, nuclear activities, radiation from natural sources, design, construction and operation of nuclear facilities, statistically processed absorbed doses of exposed workers and members of the public, handling of radioactive waste and spent fuel, import, export, transit and transport of radioactive waste and radioactive substances, radioactive contamination of the environment, food, feed and general use products, emergencies and plans for protection and rescue in case of emergency shall be public, unless classified pursuant to lex specialis. (2) The procedures for access to information in accordance with the law shall apply to the access to information referred to in paragraph 1 of this Article. II STATE OFFICE FOR RADIOLOGICAL AND NUCLEAR SAFETY Establishment of the State Office for Radiological and Nuclear Safety Article 6 (1) The State Office for Radiological and Nuclear Safety, as the state administration body competent for activities relating to protection against ionising radiation and nuclear safety, is hereby established. (2) For the purpose of implementing measures for nuclear safety and protection against ionising radiation, the State Office for Radiological and Nuclear Safety shall perform the following tasks:

9 1. approve the carrying out of nuclear activities, 2. approve the carrying out of practices involving sources of ionising radiation, 3. approve procurement, import, export, transport and transit of ionising radiation sources, 4. authorise the use of ionising radiation sources, 5. conduct independent safety analyses and issue decisions or certificates regarding the location, design, construction, operation and decommissioning of a facility in which a nuclear activity is to be performed, 6. take part in the procedure for issuing location permits, building permits, permits for removal and in the procedure for issuing use permits for structures that accommodate sources of ionising radiation or in which practices involving sources of ionising radiation are carried out in accordance with lex specialis, 7. approve and supervise the professional operations of authorised technical services and authorised experts for nuclear safety, 8. organise and supervise, and where necessary also carry out tests on the presence of the type and intensity of ionising radiation in the environment, food and feed, medicinal products and general use products under regular conditions as well as in cases of suspected emergency, 9. keep records on the licences, approvals, decisions and certificates which it has issued within the scope of its authority, and maintain and supervise records on ionising radiation sources, licensees and licence holders, beneficiaries, exposed workers, level of irradiation of exposed workers as well as the level of irradiation of persons subject to medical exposure and of other persons, 10. carry out inspections to ensure the implementation of the provisions of this Act and regulations adopted on the basis thereof, 11. elaborate technical platforms for teaching curricula and programmes for regular and additional education as well as for renewal of knowledge in the field of protection against ionising radiation, 12. ensure expert assistance in implementing the national plan and programme for procedures in the event of a nuclear accident and emergencies connected with sources of ionising radiation, 13. inform the mass media, competent bodies, organisations, associations and international institutions on emergencies connected with sources of ionising radiation, 14. provide expert assistance and cooperation in activities for preventing illicit trafficking in nuclear and other radioactive material to state administration bodies competent for such activities, 15. monitor safety conditions at nuclear power plants in the region and carries out assessments of the threat of nuclear accidents there, especially in the Krško Nuclear Power Plant in Slovenia and the Paks Nuclear Power Plant in Hungary, 16. provide dosimetric assessments of exposure to ionising radiation of exposed workers, of the population from medical exposure and from exposure to ionising radiation originating from environmental radionuclides, 17. fulfil the obligations which the Republic of Croatia has assumed through international conventions and bilateral agreements concerning protection against ionising radiation, nuclear safety and the application of protective measures aimed at the non-proliferation of nuclear weapons, 18. cooperate with international and domestic organisations and associations in the area of protection against ionising radiation and nuclear safety, and appoint its own expert representatives to take part in the work of such organisations and associations or to monitor their work, 19. coordinate technical cooperation with the International Atomic Energy Agency for all

10 participants from the Republic of Croatia, 20. stimulate and support scientific and research and development activities, encourage professional, statistic and other research in accordance with the demands and requirements of the development of nuclear safety and protection against ionising radiation in the Republic of Croatia, 21. issue instructions for implementing international recommendations and standards in the area of protection against ionising radiation and nuclear safety and design the standards and methods in monitoring the state of protection against ionising radiation, 22. carry out other activities under its competence pursuant to this Act, regulations adopted on the basis thereof, and other regulations. Appointment of the head Article 7 (1) The head of the State Office for Radiological and Nuclear Safety shall be its director. (2) The director shall be appointed by the Government of the Republic of Croatia. (3) The director shall be responsible to the Government for his/her work. III CARRYING OUT A PRACTICE INVOLVING IONISING RADIATION SOURCES AND WORK ACTIVITIES Licence for practice Article 8 (1) A practice involving ionising radiation sources shall not be initiated before the State Office for Radiological and Nuclear Safety has issued a licence. (2) The licence referred to in paragraph 1 of this Article shall be granted or withheld by a decision against which an appeal is not permitted but an administrative dispute may be instituted. (3) The list of practices, the conditions for issuing and modifying licences referred to in paragraph 1 of this Article and the period of validity of the licences referred to in paragraph 1 of this Article shall be prescribed by an ordinance issued by the director of the State Office for Radiological and Nuclear Safety, subject to the approval of the minister competent for health. (4) The licence referred to in paragraph 1 of this Article for the Armed Forces of the Republic of Croatia shall be granted by the minister competent for defence, subject to prior opinion of the director of the State Office for Radiological and Nuclear Safety.

11 Work activities Article 9 The list of work activities, as well as the requirements for carrying out work activities shall be prescribed by an ordinance issued by the director of the State Office for Radiological and Nuclear Safety subject to the approval of the minister competent for health. Licence for use of ionising radiation sources Article 10 (1) The licensee referred to in Article 8 of this Act may not begin using the ionising radiation source before being issued a licence for use of that source by the State Office for Radiological and Nuclear Safety. (2) The licence referred to in paragraph 1 of this Article shall be granted or withheld by a decision against which an appeal is not permitted but an administrative dispute may be initiated. (3) The requirements for issuing the licence and the period of validity of the licence referred to in paragraph 1 of this Article shall be prescribed by an ordinance issued by the director of the State Office for Radiological and Nuclear Safety, subject to the approval of the minister competent for health. Derogation from the requirement of obtaining a licence for practice or licence for use Article 11 (1) The provisions of Articles 8 and 10 of this Act shall not apply to radioactive substances and practices involving such a substance, insofar as one of the following requirements is fulfilled: 1. total activity or concentration of activity of radionuclides involved in the practice does not exceed the values prescribed in the ordinance issued by the director of the State Office for Radiological and Nuclear Safety, subject to the approval of the minister competent for health, 2. activity or radionuclide activity concentration in a radioactive substance does not exceed the value prescribed in the ordinance referred to in item 1 of this paragraph. (2) The provisions of Article 8 and 10 of this Act shall not apply to x-ray sets, accelerators or other electrical devices producing ionising radiation and the practice therewith, insofar as the following two conditions are fulfilled: 1. maximum voltage difference of the electrical device producing ionising radiation does not exceed 30 kv at any moment throughout use, 2. absorbed dose in a unit of time at a distance of 0.1 m from any accessible surface of the electrical device producing ionising radiation may not exceed 1 µgy per hour under any circumstance. (3) The provisions of Article 8 and 10 of this Act shall not apply to substances or devices contaminated by radionuclides whose concentration does not exceed the concentrations for which discharge is permitted, which shall be prescribed by an ordinance issued by the director of the State Office for Radiological and Nuclear Safety subject to the approval of the minister competent for health.

12 (4) The provisions of Article 8 of this Act shall not apply to practices involving sealed radioactive sources if the absorbed dose per unit of time at a distance of 0.1 m from any accessible surface of the sealed radioactive source or device accommodating the sealed radioactive source may not exceed 1 µgy per hour under any circumstance. (5) The provisions of Article 8 of this Act shall not apply to practices involving depleted uranium shields and ballasts. (6) The beneficiary shall not start using the radioactive source referred to in paragraph 4 of this Article or depleted uranium shields and ballasts before the State Office for Radiological and Nuclear Safety has issued a licence for use of such a source. Withdrawal of the licence for practice and the licence for use of ionising radiation sources Article 12 The State Office for Radiological and Nuclear Safety shall withdraw the authorisation referred to in Article 8, paragraph 1 of this Act or the licence for use of the ionising radiation sources referred to in Article 10, paragraph 1 and Article 11, paragraph 6 of this Act if it is established that the licensee or the beneficiary does not meet the requirements prescribed by this Act and subordinate legislation adopted on the basis thereof. Responsibilities of the licensees and licence holders Article 13 The licensee shall be responsible for the implementation of radiological safety measures and shall bear the costs of their implementation. IV NUCLEAR ACTIVITIES 1. Notification of intention Notification of intention to perform a nuclear activity Article 14 A legal person that intends to perform a nuclear activity must notify the State Office for Radiological and Nuclear Safety of its intention within the period prescribed by the ordinance referred to in Article 16 of this Act. Notification of intention to import or export nuclear material or specified equipment Article 15 A nuclear material or specified equipment user must notify the State Office for Radiological and Nuclear Safety of its intention to import or export nuclear material or specified equipment no later than 30 days prior to the planned import or export of nuclear material or specified equipment.

13 A list of nuclear materials and specified equipment, nuclear activities, the procedure and deadline for notification of intention and the format and content of the notification Article 16 A list of nuclear materials and specified equipment, nuclear activities, the procedure and deadline for notification of an intention to perform a nuclear activity as well as the format and content of forms for notification of intention shall be prescribed by an ordinance issued by the director of the State Office for Radiological and Nuclear Safety. 2. Performance of nuclear activities Licence for performing a nuclear activity Article 17 (1) A nuclear activity shall not be initiated before the State Office for Radiological and Nuclear Safety has issued a licence for performing that activity. (2) The licence referred to in paragraph 1 of this Article shall be granted or withheld by a decision against which an appeal is not permitted but an administrative dispute may be instituted. (3) The list of nuclear activities, requirements for issuing and modifying licences for performing a nuclear activity as well as the period of validity and requirements for extending the periods of validity of the licences referred to in paragraph 1 of this Article shall be prescribed by an ordinance issued by the director of the State Office for Radiological and Nuclear Safety. Withdrawal of a licence Article 18 The State Office for Radiological and Nuclear Safety shall withdraw the licence for performing a nuclear activity if it is established that the licence holder does not meet the requirements prescribed by this Act and subordinate legislation adopted on the basis thereof. Responsibilities of the licence holders Article 19 The licence holder shall be responsible for the implementation of radiological safety measures and nuclear safety measures and shall bear the costs of their implementation.

14 V PROTECTION AGAINST IONISING RADIATION 1. Principles of protection against ionising radiation Principles of protection against ionising radiation Article 20 Measures for protection against ionising radiation must ensure the implementation of the justification, optimisation and dose limitation principles. Justification principle Article 21 (1) The justification principle with regard to practices involving sources of ionising radiation is realised if the activity involving irradiation of persons provides benefit to exposed individuals or the society which in all circumstances exceeds the harm resulting from exposure to ionising radiation, taking into account economic, social and other factors. (2) The justification principle with regard to interventions is realised in such a way that any intervention must alleviate the consequences of an emergency, and especially reduce the exposure of persons to ionising radiation resulting from an emergency. Optimisation principle Article 22 (1) The principle of optimisation of protection against ionising radiation with regard to practices involving ionising radiation sources or nuclear activities is realised through implementation of protection measures by which the exposure of workers and other persons to ionising radiation from all practices involving ionising radiation sources, nuclear activities and from all sources of ionising radiation is reduced as much as reasonably possible within the prescribed limits, taking into account technical, organisational, economic, health and social factors. (2) The principle of optimisation with regard to interventions is realised in such a way that implementation, scope and duration of any intervention must attain the greatest positive effect reasonably possible. Dose limitation principle Article 23 The dose limitation principle concerning practices involving ionising radiation sources or nuclear activities is realised by limiting the individual s exposure, while the applied radiological and nuclear safety measures set out in this Act must ensure that the exposure of persons to ionising radiation does not exceed the established dose limits.

15 2. Safety measures for sources of ionising radiation Dose limits Article 24 The exposure limits for a member of the public, exposed worker, certain organs or tissues of the human body, apprentices and students, exposure limits in special circumstances owing to implementation of interventions in an emergency as well as the limits between an area under supervision and an area under special supervision shall be prescribed by an ordinance issued by the director of the State Office for Radiological and Nuclear Safety subject to the approval of the minister competent for health. Age limit for exposed workers Article 25 (1) Persons under 18 must not carry out a practice exposing them to potential irradiation levels exceeding the limits prescribed by the provision of Article 24 of this Act. (2) Apprentices and students undergoing training or education for working with ionising radiation sources must not be under 16. Protection during pregnancy and breastfeeding Article 26 (1) The licensee, licence holder, or the beneficiary shall arrange for an exposed female worker to work during pregnancy at a work post where the effective dose does not annually exceed 1 msv. (2) Breastfeeding women shall not occupy a work post where there is a possibility of radioactive contamination. Medical irradiation Article 27 (1) Dose limits specified in this Act shall not apply to medical irradiation. (2) The conditions, method and measures for protection of persons exposed to medical irradiation shall be prescribed by an ordinance issued by the director of the State Office for Radiological and Nuclear Safety subject to the approval of the minister competent for health. Personal dose measurement

16 Article 28 (1) Measurement of the personal dose of exposed workers or apprentices or students shall be performed systematically by individual measurement of external irradiation, while in the case of workers working with open radioactive sources internal irradiation must also be measured and/or assessed. (2) The method, scope and deadlines of measurement of the personal dose referred to in paragraph 1 of this Article shall be prescribed by an ordinance issued by the director of the State Office for Radiological and Nuclear Safety subject to the approval of the minister competent for health. Technical competency Article 29 (1) Exposed workers must have adequate training, and workers who operate sources of ionising radiation must also have special professional training for operating sources of ionising radiation. (2) Exposed workers and workers who operate sources of ionising radiation must have special professional training regarding the application of measures for protection against ionising radiation. (3) The training referred to in paragraph 2 of this Article pertaining to the application of measures for protection against ionising radiation shall be acquired by exposed workers and workers who operate sources of ionising radiation in the course of regular schooling or additional training. (4) Exposed workers and workers who operate sources of ionising radiation must periodically renew their knowledge on the application of measures for protection against ionising radiation. (5) Additional training referred to in paragraph 3 of this Article and renewal of knowledge referred to in paragraph 4 of this Article shall be organised and performed by legal persons who meet the requirements prescribed by an ordinance issued by the director of the State Office for Radiological and Nuclear Safety, subject to the approval of the minister competent for health. (6) The required professional training, as well as the conditions, deadlines and the method for acquiring the professional training referred to in paragraph 1 of this Article and the renewal of knowledge on the application of measures for protection against ionising radiation and requirements referred to in paragraph 5 of this Article shall be prescribed by an ordinance issued by the director of the State Office for Radiological and Nuclear Safety, subject to the approval of the minister competent for health. Medical examinations Article 30 (1) Exposed workers must fulfil special health requirements. (2) Medical fitness for working with sources of ionising radiation must be checked in pupils and students prior to beginning education for work with sources of ionising radiation and in exposed

17 apprentices and workers prior to beginning work involving sources of ionising radiation as part of the preliminary medical examination. (3) Medical fitness of the persons referred to in paragraphs 1 and 2 of this Article shall be checked as part of the regular or special medical examination. (4) Medical requirements to be fulfilled by the persons referred to in paragraph 2 of this Article, frequency of examinations as well as the content, manner and deadlines for keeping data on such examinations shall be prescribed by an ordinance issued by the director of the State Office for Radiological and Nuclear Safety subject to the approval of the minister competent for health and the director of the state institute competent for health protection and occupational safety. Article 31 Checking medical fitness of the persons referred to in Article 30 of this Act shall be carried out by medical institutions practicing occupational medicine, companies practicing occupational medicine and private occupational medicine practitioners authorised by the minister competent for health. Obligations of training institutions Article 32 (1) Institutions providing curricula for training and instruction of candidates for carrying out practices involving ionising radiation sources must provide for their candidates the examination of medical fitness and measurement of personal doses in the course of training. (2) Institutions providing curricula for training and instruction of candidates for carrying out practices involving ionising radiation sources are permitted to enrol candidates who meet the requirements set out in the ordinance referred to in Article 30, paragraph 4 of this Act. Requirements concerning premises and devices Article 33 (1) Premises, devices and installations accommodating sources of ionising radiation or where practices involving sources of ionising radiation take place, the ionising radiation sources, protective equipment and personal protective equipment must comply with the requirements ensuring radiological safety and protection of people and the environment against ionising radiation and against contamination by radioactive substances. (2) The requirements referred to in paragraph 1 of this Article shall be prescribed by an ordinance issued by the director of the State Office for Radiological and Nuclear Safety subject to the approval of the minister competent for health. (3) The ordinance specifying the requirements for the design, construction, use and removal of structures accommodating sources of ionising radiation or in which practices involving sources of ionising radiation take place shall be issued by the director of the State Office for Radiological and Nuclear Safety, subject to the approval of the minister competent for construction and the minister competent for health, and in the part relating to physical protection, the minister competent for internal affairs as well.

18 Establishment and application of measures for protection of exposed workers and supervision of work posts Article 34 The licensee and licence holder must ensure the following: checking medical fitness of exposed workers, measuring personal doses of exposed workers, education on application of measures for protection against ionising radiation for exposed workers, inspection of the ionising radiation sources and work conditions as well as the measurement of prescribed elements, quality assurance programme and its implementation, quality control, personal protective devices and equipment for exposed workers as well as checking the proper working order of such devices, regular calibration and checking the proper working order of measuring instruments, checking radioactive contamination of persons, objects, the environment, premises and air in the premises where the practice is carried out or where the ionising radiation sources are located. Measurement method, scope and deadlines, quality control, contents of the quality assurance programme, contents of the report and reporting frequency, deadlines and procedure Article 35 The method, scope and deadlines for measuring the personal doses of workers exposed to medical irradiation, inspecting the ionising radiation source and working conditions, measuring the prescribed elements and quality control, checking the proper working order of personal protective devices and equipment, checking the proper working order of measuring instruments, checking the radioactive contamination of persons, objects, environment, premises and air in the premises where the practice involving ionising radiation sources is carried out or where the radioactive sources are situated, as well as the content of the quality assurance programme and the mandatory content of reports on examinations, controls and measurements as well as the frequency, deadlines and procedure for reporting shall be prescribed by an ordinance issued by the director of the State Office for Radiological and Nuclear Safety subject to the approval of the minister competent for health. Obligation of implementing self-protection measures Article 36 In their work, exposed workers shall implement all prescribed and standard self-protection measures against ionising radiation as well as those for protection of other persons, use protective devices and equipment for measuring personal doses and use any other measures necessary for protection against ionising radiation. Person responsible for protection against ionising radiation

19 Article 37 (1) The licensee, the licence holder and the beneficiary shall be obliged to appoint a person responsible for protection against ionising radiation. (2) The person responsible for protection against ionising radiation must, with regard to professional education, fulfil the requirements set out in an ordinance issued by the director of the State Office for Radiological and Nuclear Safety subject to the approval of the minister competent for health. (3) The person responsible for protection against ionising radiation shall perform the following tasks: exercise internal control over the application of measures for protection against ionising radiation, provide for the use of protective devices and equipment and devices for measuring personal doses of exposed workers, provide for carrying out the medical checks of exposed workers, provide for professional competency of exposed workers for work involving ionising radiation sources and the application of measures for protection against ionising radiation as well as for the renewal of knowledge of exposed workers, provide for inspection of ionising radiation sources within the prescribed time limits, be present during inspectional supervision and respond to the findings of the inspector, ensure the keeping of all prescribed records, organise the carrying out of protective measures in the case of an emergency. (4) The person responsible for protection against ionising radiation must without delay inform the State Office for Radiological and Nuclear Safety of a violation of the provisions of this Act and subordinate legislation adopted on the basis thereof that threatens the life and health of human beings. (5) In the event that the violation of the provisions of this Act and subordinate legislation adopted on the basis thereof threatens nature or the environment, the person responsible for protection against ionising radiation shall be obligated to inform without delay the state administration body competent for environmental protection and the State Office for Radiological and Nuclear Safety. Authorised technical service Article 38 (1) The tasks of protection against ionising radiation shall be performed by authorised technical services authorised by a decision issued by the State Office for Radiological and Nuclear Safety. (2) The list of tasks for protection against ionising radiation, requirements to be fulfilled by authorised technical services and the method of granting authorisation shall be prescribed by an ordinance issued by the director of the State Office for Radiological and Nuclear Safety subject to the approval of the minister competent for health.

20 Prohibition of use of radioactive substances Article 39 (1) Intentional adding of radioactive substances in the manufacture of food, feed and general use products as well as import and export of such goods shall be prohibited. (2) Working and living premises may not be used if they are contaminated with radionuclides above the limits prescribed by the ordinance issued by the director of the State Office for Radiological and Nuclear Safety, subject to the approval of the minister competent for health. (3) Import, export and placing on the market of food, feed and general use products shall be prohibited if they are contaminated with radionuclides above the limits prescribed by the ordinance issued by the director of the State Office for Radiological and Nuclear Safety, subject to the approval of the minister competent for health. VI NUCLEAR SAFETY 1. Guarantee of nuclear safety Prohibition and guarantee of the safety of nuclear facilities Article 40 (1) A nuclear facility may not be constructed, tested, commissioned or used in any other way if all the approvals or licences pursuant to this Act have not been issued. (2) A holder of the use permit for a nuclear facility referred to in paragraph 1 of this Article shall be responsible for nuclear safety of the facility referred to in paragraph 1 of this Article, including safety when handling radioactive substances, radioactive waste or spent nuclear fuel, which are located or occur in the aforementioned facilities. Authorised experts for nuclear safety Article 41 (1) The authorisation for an expert for nuclear safety shall be issued for an individual area of nuclear safety or for more areas for a period not exceeding five years. (2) The authorised experts for nuclear safety must report on their work to the State Office for Radiological and Nuclear Safety once a year and more frequently at the request of the director of the State Office for Radiological and Nuclear Safety. (3) The State Office for Radiological and Nuclear Safety shall withdraw the authorisation for an authorised expert for nuclear safety if it is established that the authorised expert does not meet the conditions under which the authorisation was issued.