S.I. No. 30/2019 - Radiological Protection Act 1991 (Ionising Radiation) Regulations 2019

Notice of the making of this Statutory Instrument was published in

“Iris Oifigúil” of 8th of February, 2019

ARRANGEMENT OF REGULATIONS

Part 1 – CITATIONS, DEFINITIONS AND SCOPE	Part 1 – CITATIONS, DEFINITIONS AND SCOPE
Regulation 1	Citation
Regulation 2	Definitions
Regulation 3	Scope
Regulation 4	Exclusion from Scope
Part 2 – REGULATORY CONTROL	Part 2 – REGULATORY CONTROL
Section 1 – Justification	Section 1 – Justification
Regulation 5	Justification of Practices
SECTION 2 – Graded Approach to Authorisation	SECTION 2 – Graded Approach to Authorisation
Regulation 6	Practices involving consumer products
Regulation 7	Prohibition of practices
Section 2 – Graded Approach to Authorisation	Section 2 – Graded Approach to Authorisation
Regulation 8	Notification
Regulation 9	Exemption from Notification
Regulation 10	Registration or licensing
Regulation 11	Licensing
Regulation 12	Authorisation
Regulation 13	Authorisation procedure
Regulation 14	Conditions specified in a Licence
Regulation 15	Conditions attached to a Registration
Regulation 16	Non-medical imaging practices
Regulation 17	Radioactive Waste Licences
Regulation 18	Licensing of importation and exportation of Radioactive Waste
Regulation 19	Release from regulatory control
Part 3 – SYSTEM OF RADIATION PROTECTION	Part 3 – SYSTEM OF RADIATION PROTECTION
Section 1 – Tools for optimisation	Section 1 – Tools for optimisation
Regulation 20	Dose constraints for occupational and public exposure
Regulation 21	Reference levels
Section 2 – Dose limitation	Section 2 – Dose limitation
Regulation 22	Age limit for exposed workers
Regulation 23	Dose limits for occupational exposure
Regulation 24	Protection of pregnant and breastfeeding workers
Regulation 25	Specially authorised exposures
Regulation 26	Dose Limits for apprentices and students
Regulation 27	Dose Limits for public exposure
Regulation 28	Estimation of the Effective and Equivalent Dose
Part 4 – PROTECTION OF EXPOSED WORKERS, APPRENTICES AND STUDENTS	Part 4 – PROTECTION OF EXPOSED WORKERS, APPRENTICES AND STUDENTS
Regulation 29	Responsibilities of the undertaking and employers
Regulation 30	Arrangements in workplaces
Regulation 31	Prior Risk Assessment
Regulation 32	Radiation Safety Procedures
Regulation 33	Consultations with a Radiation Protection Adviser
Regulation 34	Role of Radiation Protection Officer
Regulation 35	Radiation Protection Education, Training and Information
Regulation 36	Classification of workplaces
Regulation 37	Requirements for Controlled and Supervised Areas
Regulation 38	Radiological surveillance of the workplace
Part 5 – CATEGORISATION AND MONITORING OF WORKERS	Part 5 – CATEGORISATION AND MONITORING OF WORKERS
Regulation 39	Categorisation of exposed workers
Regulation 40	Operational protection of apprentices and students
Regulation 41	Individual Monitoring
Regulation 42	Recording and Reporting of Results
Regulation 43	Access to the Results of Individual Monitoring
Regulation 44	National Dose Register
Regulation 45	Medical surveillance of exposed workers
Regulation 46	Medical classification
Regulation 47	Medical records
Regulation 48	Special medical surveillance
Regulation 49	Appeals in relation to medical surveillance
Regulation 50	Duties of Exposed Workers, Apprentices, Students and Employers
Part 6 – PUBLIC EXPOSURES	Part 6 – PUBLIC EXPOSURES
Regulation 51	Operational protection of members of the public
Regulation 52	Tasks for the undertaking
Regulation 53	Monitoring of radioactive discharges
Regulation 54	Estimation of doses to members of the public
Part 7 – EMERGENCY PREPAREDNESS AND RESPONSE	Part 7 – EMERGENCY PREPAREDNESS AND RESPONSE
Regulation 55	National Plan for Nuclear and Radiological Emergency Exposures
Regulation 56	Contaminated Areas and Existing Exposure Situations
Regulation 57	Major Emergency Plans
Regulation 58	Emergency Preparedness for Licensed Undertakings
Regulation 59	Duty of Undertakings to inform members of the public likely to be affected in the event of a radiological exposure situation
Regulation 60	Emergency response for Undertakings
Regulation 61	Communication and recording of significant events
Regulation 62	Emergency occupational exposure
Regulation 63	Prior information and training for emergency workers
Part 8 – NATURALLY OCCURRING RADIATION	Part 8 – NATURALLY OCCURRING RADIATION
Regulation 64	National Radon Control Strategy
Regulation 65	Indoor exposure to radon in domestic dwellings
Regulation 66	Radon in workplaces
Regulation 67	Gamma radiation from building materials
Regulation 68	Identification of practices involving naturally-occurring radioactive material
Part 9 – CONTROL OF RADIOACTIVE SOURCES	Part 9 – CONTROL OF RADIOACTIVE SOURCES
Regulation 69	Control of radioactive sources and radiation generators
Regulation 70	Requirements for control of high-activity sealed sources
Regulation 71	Specific requirements for licensing of high-activity sealed sources
Regulation 72	Record keeping by the undertaking
Regulation 73	Record keeping by the competent authority
Regulation 74	Control of high-activity sealed sources
Regulation 75	Metal Contamination in recycling installations
Regulation 76	Detection of Orphan Sources
Regulation 77	Recovery and disposal of orphan sources
Part 10 – SERVICES AND EXPERTS	Part 10 – SERVICES AND EXPERTS
Regulation 78	Recognition of Dosimetry Services
Regulation 79	Radiation Protection Advisers
Regulation 80	Radiation Protection Officers
Part 11 – ENFORCEMENT	Part 11 – ENFORCEMENT
Regulation 81	Inspections
Regulation 82	Enforcement Notices
Part 12 – REVOCATION OF LEGISLATION	Part 12 – REVOCATION OF LEGISLATION
Regulation 83	Revocations
Part 13 – TRANSITIONAL PROVISIONS	Part 13 – TRANSITIONAL PROVISIONS
Regulation 84	Licences
Regulation 85	Applications for Licences
Regulation 86	Dosimetry Services
Regulation 87	Radiation Protection Advisers
SCHEDULE 1	SCHEDULE 1
SCHEDULE 2	SCHEDULE 2
SCHEDULE 3	SCHEDULE 3
SCHEDULE 4	SCHEDULE 4
SCHEDULE 5	SCHEDULE 5
SCHEDULE 6	SCHEDULE 6
SCHEDULE 7	SCHEDULE 7
SCHEDULE 8	SCHEDULE 8
SCHEDULE 9	SCHEDULE 9
SCHEDULE 10	SCHEDULE 10
SCHEDULE 11	SCHEDULE 11
SCHEDULE 12	SCHEDULE 12
SCHEDULE 13	SCHEDULE 13
SCHEDULE 14	SCHEDULE 14
SCHEDULE 15	SCHEDULE 15
SCHEDULE 16	SCHEDULE 16

RADIOLOGICAL PROTECTION ACT 1991 (IONISING RADIATION) REGULATIONS 2019

S.I. No. 30 of 2019

I, RICHARD BRUTON, Minister for Communications, Climate Action and Environment, in exercise of the powers conferred on me by subsections (1) and (2) of Section 30 of the Radiological Protection Act 1991 (No. 9 of 1991), after consultation with the Ministers for Public Expenditure and Reform, Health, Housing, Planning and Local Government, and the Environmental Protection Agency, Health Information and Quality Authority, and the Health and Safety Authority for the purpose of giving effect to Council Directive 2013/59/EURATOM of 5 December 2013¹ , as affected by Corrigendum to Council Directive 2013/59/EURATOM² , laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation and for the purpose of giving further effect to Council Directive 2011/70/EURATOM of 19 July 2011³ establishing a Community framework for the responsible and safe management of spent fuel and radioactive waste, hereby make the following Regulations: –

Part 1 - CITATIONS, DEFINITIONS AND SCOPE

Citation

1.

1. These Regulations may be cited as the Radiological Protection Act 1991 (Ionising Radiation) Regulations 2019.

Definitions

2.

2. (1) In these Regulations: –

“Absorbed dose” (D) is 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 these Regulations, absorbed dose denotes the dose averaged over a tissue or an organ. The unit for absorbed dose is the gray (Gy) where one gray is equal to one joule per kilogram:

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

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

“activation” means a process through which a stable nuclide is transformed into a radionuclide by irradiating with particles or high-energy photons the material in which it is contained;

“activity” (A), other than in relation to a human activity or a relevant activity, is the activity of an amount of a radionuclide in a particular energy state at a given time. It is the quotient of dN by dt, where dN is the expectation value of the number of nuclear transitions from that energy state in the time interval dt: –

The unit of activity is the becquerel (Bq);

“air crew” means the cabin and flight crew of an aircraft operated by an air operator or an undertaking in the State which operates an aircraft;

“air operator” means the holder of an Air Operator’s Certificate issued by the Irish Aviation Authority in accordance with the Irish Aviation Authority (Air Operators’ Certificate) Order 1999 ( S.I. No. 420 of 1999 );

“apprentice” means a person receiving training or instruction within an undertaking with a view to the person concerned exercising a specific skill;

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

“authorisation” means the registration or licensing of a practice;

“becquerel” (Bq) is the special name of the unit of activity. One becquerel is equivalent to one nuclear transition per second: [image omitted];

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

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

“category A worker” means an exposed worker designated as such pursuant to Regulation 39;

“category B worker” means an exposed worker designated as such pursuant to Regulation 39;

“clearance levels” means values established by the Agency or in national legislation, and expressed in terms of activity concentrations, at or below which materials arising from any practice subject to notification or authorisation may be released from the requirements of these Regulations;

“closure” means the completion of all operations at some time after the emplacement of radioactive waste in a disposal facility, including the final engineering or other work required to bring the facility to a condition that will be safe in the long term;

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

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

“committed equivalent dose” (HT(τ)) is the integral over time (t) of the equivalent dose rate in tissue or organ T that will be received by an individual as a result of an intake.

It is given by: –

for an intake at time t0 where

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

“competent authority” means the Environmental Protection Agency (“the Agency”) established under Section 19 of the Environmental Protection Agency Act 1992 (No. 7 of 1992);

“Competition and Consumer Protection Commission” means the body established under section 9 of the Competition and Consumer Protection Act 2014 ;

“Community” means the European Atomic Energy Community;

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

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

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

“Council Directive” means Council Directive 2013/59/EURATOM of 5 December 2013, laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, as affected by Corrigendum to Council Directive 2013/59/EURATOM, and repealing Directives 89/618/EURATOM, 90/641/EURATOM, 96/29/EURATOM, 97/43/EURATOM and 2003/122/EURATOM;

“disposal” means, in relation to radioactive waste, the emplacement of waste in a repository, or a given location, without the intention of retrieval;

“disposal facility” means any facility or installation the primary purpose of which is radioactive waste disposal;

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

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

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

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

Where

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 values for wT and WR are specified in Schedule 2. The unit for effective dose is the sievert (Sv);

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

“emergency exposure situation” means a situation of exposure due to an emergency;

“emergency occupational exposure” means exposure received in an emergency exposure situation by an emergency worker;

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

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

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

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

where

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 values for WR are specified in Schedule 2, Part A. The unit for equivalent dose is the sievert (Sv);

“exemption level” means a value established by the Agency or in these regulations and expressed in terms of activity concentration or total activity at or below which a radiation source is not subject to notification or authorisation;

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

“exposed worker” means a person, either self-employed or working under an employer, who is subject to exposure at work carried out within a practice regulated by these Regulations and who is liable to receive doses exceeding one or other of the dose limits for public exposure;

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

“exposure to radon” means exposure to radon progeny;

“extremities” means the hands, forearms, feet and ankles;

“high-activity sealed source” means a sealed source for which the activity of the contained radionuclide is equal to or exceeds the corresponding activity value laid down in Schedule 3;

“high radon area” means an area where the Agency predicts that more than 10% of domestic dwellings in that area will have radon concentrations above the national reference level or such other area as the Agency may determine from time to time;

“inspection” means an investigation by or on behalf of the Agency to verify compliance with national legal requirements;

“inspector” means a person appointed under Section 28 of the Principal Act to be an inspector for the purposes of that Act and orders or regulations made under it;

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

“ionising radiation” means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or less (a frequency of 3 × 10^15 hertz or more) capable of producing ions directly or indirectly;

“irradiating apparatus” means an electrical apparatus capable of producing ionising radiation and containing components operating at a potential difference of more than 5kV;

“licence” means permission granted in a document by the Agency to carry out a practice in accordance with specific conditions (if any) laid down in that document;

“local authority” has the meaning given to it in the Local Government Act 2001 ;

“local government area” shall be read in accordance with section 10 of the Local Government Act 2001 ;

“medical exposure” means exposure incurred by patients or asymptomatic individuals as part of their own medical or dental diagnosis or treatment, and intended to benefit their health, as well as exposure incurred by carers and comforters and by volunteers in medical or biomedical research;

“medical physics expert” has the meaning given to it in Regulation 2(1) of the European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018 ( S.I. No. 256 of 2018 );

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

“Member State” means a Member State of the European Union;

“Minister” means the Minister for Communications, Climate Action and Environment;

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

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

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

“notification” means submission of information to the Agency to notify the intention to carry out a practice within the scope of these Regulations;

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

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

“orphan source” means a radioactive source which is neither exempted nor under regulatory control, for example because it has never been under regulatory control or because it has been abandoned, lost, misplaced, stolen or otherwise transferred without proper authorisation;

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

“planned exposure situation” means an exposure situation that arises from the planned operation of a radiation source or from a human activity which alters exposure pathways, so as to cause the exposure or potential exposure of people or the environment and may include both normal exposures and potential exposures;

“potential exposure” means exposure that is not expected with certainty but may result from an event or sequence of events of a probabilistic nature, including equipment failures and operating errors;

“practice” means a relevant activity that is managed as a planned exposure situation;

“practitioner” has the meaning given to it in Regulation 2(1) of the European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018 ( S.I. No. 256 of 2018 );

“Principal Act” means the Radiological Protection Act 1991 (No. 9 of 1991);

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

“protective measures” means measures, other than remedial measures, for the purpose of avoiding or reducing doses that might otherwise be received in an emergency exposure situation or an existing exposure situation;

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

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

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

“radiation generator” means a device capable of generating ionising radiation, such as X-rays, neutrons, electrons or other charged particles including irradiating apparatus and nuclear generators;

“radiation passbook” means: –

• (a) in the case of an outside worker a passbook approved for the purposes of these Regulations by the Agency in accordance with the requirements of Schedule 9;

• (b) in the case of an outside worker employed in another Member State, a passbook authorised by a competent authority of that Member State; and

• (c) in the case of an outside worker employed in a third country, a passbook authorised by a competent authority of that country;

“radiation protection adviser” means an individual or a body, having the knowledge, training and experience needed to give radiation protection advice in order to ensure the effective protection of individuals, which meets such criteria of competence as may from time to time be specified in writing by the Agency;

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

“radiation source” means an entity that may cause exposure, such as by emitting ionising radiation or by releasing radioactive material and encompasses radiation generator, radioactive material, radioactive source and radioactive substance;

“radioactive material” means material incorporating radioactive substances;

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

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

“radioactive waste” means radioactive material in gaseous, liquid or solid form for which no further use is foreseen or considered by the Agency or by a legal or natural person whose decision is accepted by the Agency, and which is regulated as radioactive waste by the Agency;

“radioactive waste management” means all activities that relate to handling, pre-treatment, treatment, conditioning, storage, or disposal of radioactive waste, excluding off-site transportation;

“radioactive waste management facility” means any facility or installation the primary purpose of which is radioactive waste management;

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

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

“registration” means permission granted in a document by the Agency, to carry out a practice in accordance with attached conditions (if any) for this type or class of practice;

“registered person” means a person to whom a registration is for the time being granted;

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

“relevant activity” means a human activity which can increase the exposure of individuals to radiation from a radiation source and includes the custody, production, processing, handling, holding, storage, use, recycling, manufacture, import, distribution, transport, export or other disposal of the radiation source;

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

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

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

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

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

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

“standard values and relationships” means values and relationships recommended in chapters 4 and 5 of International Commission on Radiological Protection (ICRP) Publication 116⁴ for the estimation of doses from external exposure and chapter 1 of ICRP Publication 119⁵ for the estimation of doses from internal exposure, including updates approved by the Agency. The use of specific methods in specified cases relating to the physico-chemical properties of the radionuclide or other features of the exposure situation or of the exposed individual may be approved by the Agency;

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

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

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

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

“Waste Directive” means Council Directive 2011/70/EURATOM of 19 July 2011 establishing a Community framework for the responsible and safe management of spent fuel and radioactive waste;

“workplace” includes any place, land or other location at, in, upon or near which, work is carried out whether occasionally or otherwise and, in particular, includes: –

• (a) a premises, including a cave or mine;

• (b) an installation on land and any offshore installation;

• (c) a tent, a temporary structure or movable structure; and

• (d) a vehicle, vessel, aircraft or spacecraft.

• (2) A word or expression which is used in these Regulations and which is also used in the Council Directive or the Waste Directive has, unless the context otherwise requires, the same meaning in these Regulations as it has in the Council Directive or the Waste Directive.

• (3) In these Regulations: –

• (a) a reference to a Regulation or Schedule is a reference to a Regulation of or Schedule to these Regulations unless it is indicated that a reference to some other enactment is intended; and

• (b) a reference to a paragraph, subparagraph or clause is a reference to a paragraph, subparagraph or clause of the provision in which the reference occurs unless it is indicated that reference to some other provision is intended.

Scope

3.

3. These Regulations apply to any planned, existing or emergency exposure situation which involves a risk from exposure to ionising radiation which cannot be disregarded from a radiation protection point of view or with regard to the environment in view of long-term human health protection including: –

• (a) the custody, manufacture, operation, production, processing, handling, use, storage, holding, transport, distribution, recycling or disposal, import, and export of radiation sources;

• (b) in relation to the use of radiation sources as a prophylactic, diagnostic or therapeutic agent for the purpose of the prevention, diagnosis or treatment of any human ailment, infirmity, injury or defect, the scope is limited to: –

• (i) the supervision and care of the radiation sources; and

• (ii) ensuring that the said radiation sources are properly calibrated and maintained so as: –

• (I) to reduce to a minimum the effects of such radiation sources on property and persons other than a patient receiving a particular medical or dental application; and

• (II) to enable a practitioner to achieve the maximum degree of accuracy and safety where the said radiation sources are used for the benefit of an individual patient.

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

• (i) the operation of aircraft and spacecraft, in relation to the exposure of crews; and

• (ii) the processing of materials with naturally-occurring radionuclides.

• (d) the exposure of workers or members of the public to radon in buildings and external exposure from building materials;

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

• (f) all stages of radioactive waste management, from generation to disposal, when the radioactive waste results from civilian activities;

• (g) cases of lasting exposure resulting from the after-effects of an emergency or a past human activity; and

• (h) any other practice specified by the Agency.

Exclusion from Scope

4.

4. These Regulations do not apply to: –

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

• (b) exposure of members of the public or workers other than air or spacecrew to cosmic radiation in flight or in space; and

• (c) above ground exposure to radionuclides present in the undisturbed earth’s crust.

Part 2 - REGULATORY CONTROL

Section 1 - Justification

Justification of practices

5.

5. (1) No practice shall be authorised under these Regulations unless it falls within a class or type of practice that is: –

• (a) carried out immediately before the commencement of these Regulations; or

• (b) justified by the Agency in regards to its economic, social, health, environmental or other benefits in relation to the detriment it may cause; or

• (c) justified by the Health Information and Quality Authority in regards to medical exposures in accordance with Regulation 7 of the European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018 ( S.I. No. 256 of 2018 ).

• (2) The Agency shall consult with the Minister before justifying a class or type of practice in accordance with subparagraph (1)(b).

• (3) The Agency may, before justifying a class or type of practice in accordance with subparagraph (1)(b), or for the purposes of a review under paragraph (4), consult with: –

• (a) such Ministers of the Government (if any) as it considers appropriate;

• (b) occupational health services;

• (c) professional bodies of practitioners;

• (d) Health Information and Quality Authority;

• (e) Health Service Executive;

• (f) Health and Safety Authority;

• (g) Food Safety Authority of Ireland; or

• (h) such other persons or bodies as the Minister may direct.

• (4) Classes or types of practice carried out or justified in accordance with paragraph (1) may be reviewed by the Agency periodically with regard to their justification, including whenever there is new and important evidence about their efficacy or potential consequences, or new and important information about other techniques and technologies.

• (5) If following such a review, a class or type of practice is deemed to be no longer justified, the Agency shall withdraw or revoke such registrations or licences, as the case may be, for the carrying out of such practices, pursuant to its powers under Section 30(5) of the Principal Act.

• (6) The Agency may publish a list of practices deemed to be justified and/or not justified, including whether particular applications of a practice fall within an accepted class or type of practice.

• (7) Practices involving occupational and public exposures shall be justified as a class or type of practice, taking into account both categories of exposures.

• (8) Each particular application of a generally accepted type of practice involving non-medical imaging exposure shall be justified by the Agency.

• (9) All individual non-medical imaging exposure procedures using medical radiological equipment shall be justified by a practitioner in advance, taking into account the specific objectives of the procedure and the characteristics of the individual involved.

Practices involving consumer products

6.

6. (1) Any undertaking intending to manufacture or import a consumer product for which the intended use is likely to be a new class or type of practice, shall provide the Agency with all relevant information including that listed in Schedule 4, Part A so as to allow the implementation of the justification requirement in Regulation 5.

• (2) The Agency shall decide whether the intended use of the consumer product is justified taking into account, inter alia: –

• (a) the performance of the consumer product justifies its intended use; and

• (b) the design is adequate in order to: –

• (i) minimise exposures in normal use and the likelihood and consequences of misuse or accidental exposures, or whether there should be conditions imposed on the technical and physical characteristics of the product;

• (ii) meet the exemption criteria;

• (iii) where applicable, the product is of an approved type and does not necessitate specific precautions for disposal when no longer in use; and

• (iv) the product is appropriately labelled and suitable documentation is provided to the consumer with instructions for proper use and disposal.

• (3) Without prejudice to paragraph (1), the Agency, as the competent authority which has received information according to that paragraph, shall inform the point of contact for the competent authorities of other Member States of this receipt and, upon request, of its decision and the basis for that decision.

• (4) The Agency shall notify the Competition and Consumer Protection Commission if the intended use of a consumer product is not justified or its use would not fulfil the criteria for exemption from notification under Regulation 9.

Prohibition of practices

7.

7. (1) The deliberate addition of radioactive substances in the production of foodstuffs, animal feeding stuffs and cosmetics is prohibited, as is the import or export of such products.

• (2) The deliberate addition of radioactive substances in the manufacture of toys and personal ornaments is also prohibited, as is the import or export of such products.

• (3) Without prejudice to the Directive 1999/2/EC ⁶ of the European Parliament and of the Council practices involving the activation of material resulting in an increase in activity in a consumer product, which at the time of placing on the market cannot be disregarded from a radiation protection point of view, shall be deemed not to be justified. However, the Agency may evaluate specific types of practices within this class with regard to their justification.

• (4) Practices involving the activation of materials used in toys and personal ornaments, resulting, at the time of the placing on the market of the products or of their manufacture, in an increase in activity, which cannot be disregarded from a radiation protection point of view, are hereby prohibited, as is the import or export of such products or materials.

Section 2 – Graded Approach to Authorisation

Notification

8.

8. (1) Undertakings shall notify the Agency before commencing any justified practice including those identified in Regulation 68, which has not been previously exempted by the Agency from the requirement for notification in accordance with Regulation 9.

• (2) Notification to the Agency shall be required in respect of radon in workplaces as specified in Regulation 66, and for existing exposure situations that are managed as a planned exposure situation as provided for in Parts 7 and 8 of these Regulations.

• (3) Notwithstanding the exemption criteria laid down in Regulation 9, in situations identified by the Agency where there is concern that a practice identified in accordance with Regulation 68 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 Agency may require that the practice be subject to notification. This is without prejudice to the provisions of the European Union (Radioactive Substances in Drinking Water) Regulations 2016 ( S.I. No. 160 of 2016 ).

• (4) Human activities involving radioactively contaminated materials resulting from authorised releases or materials cleared in accordance with Regulation 19 shall not be managed as a planned exposure situation and, hence, are not required to be notified.

• (5) A separate notification will not be necessary where an application for authorisation is submitted to the Agency.

• (6) The Agency shall produce guidelines specifying the information to be provided in the notification process.

• (7)
• (a) Without prejudice to Regulations 10 and 11, where appropriate, the Agency may exempt notified practices from the requirement for registration or licensing on the basis of the general criteria specified in Schedule 7;

• (b) In the case of moderate amounts of material, as specified by the Agency for specific types of practice, the activity concentration values laid down in Schedule 7, Table B, column 2, may be used instead of the values laid down in Schedule 7, Table A, Part 1, for the purpose of exemption from authorisation.

Exemption from Notification

9.

9. (1) The Agency may exempt justified practices, involving the following, from notification requirements: –

• (a) radioactive materials where the quantities of the activity involved do not exceed in total the exemption values set out in Column 3, Table B of Schedule 7, or higher values that, for specific applications, are approved by the Agency and satisfy the general exemption and clearance criteria set out in Schedule 7;

• (b) without prejudice to Regulation 8(4), radioactive materials where the activity concentrations do not exceed the exemption values set out in Table A of Schedule 7, or higher values that, for specific applications, are approved by the Agency and satisfy the general exemption criteria set out in Schedule 7;

• (c) apparatus containing a sealed source, provided that: –

• (i) the apparatus is of a type approved by the Agency; and

• (ii) the apparatus does not cause, in normal operating conditions, a dose rate exceeding 1μSv · h^-1 at a distance of 0.1 m from any accessible surface; and

• (iii) conditions for recycling or disposal have been specified by the Agency; or

• (d) any electrical apparatus, provided that: –

• (i) it is a cathode ray tube intended for the display of visual images, or other electrical apparatus operating at a potential difference not exceeding 30 kilo volt (kV), or it is of a type approved by the Agency; and

• (ii) it does not cause, in normal operating conditions, a dose rate exceeding 1μSv · h^-1 at a distance of 0.1 m from any accessible surface.

• (2) The Agency may exempt specific types of practices from the notification requirement subject to compliance with the general exemption criteria established in Part 3 of Schedule 7, on the basis of an assessment showing that exemption is the best option.

Registration or licensing

10.

10. (1) The Agency shall require either registration or licensing of the following practices: –

• (a) the operation of radiation generators or accelerators or radioactive sources for medical exposures or for non-medical imaging exposure purposes; and

• (b) the operation of radiation generators or accelerators, except electron microscopes, or radioactive sources for purposes not covered by subparagraph (a).

• (2) The Agency may require registration or licensing of other types of practices.

• (3) Subject to Regulation 11, the Agency shall, in accordance with paragraphs (1) and (2), determine which practices are subject to registration or licensing. The Agency shall base its decision to submit a type of practice to registration or licensing on regulatory experience taking into account: –

• (a) the magnitude of expected or potential doses resulting from the practice;

• (b) the impact that regulatory control may have in reducing such doses or improving radiological safety;

• (c) the complexity of the practice; and

• (d) safety, security and any safeguards required having regard to the circumstances in which the relevant practice is proposed to be carried out.

Licensing

11.

11. (1) Licensing shall be required for 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 operation and decommissioning of any nuclear facility and the exploitation and closure of uranium mines;

• (c) the deliberate addition of radioactive substances in the production or manufacture of consumer products or other products, including medical products, and the import of such products;

• (d) any practice involving a high-activity sealed source;

• (e) the siting, design, construction, commissioning, operation, decommissioning and closure of a radioactive waste management facility;

• (f) practices discharging significant amounts of radioactive material with airborne or liquid effluent into the environment; and

• (g) the exportation for disposal of radioactive waste from the State to another Member State or third country, or the importation for disposal in the State of radioactive waste generated in another Member State or third country.

Authorisation

12.

12. (1) The Agency shall establish and maintain: –

• (a) a register of registered practices; and

• (b) a register of licensed practices.

• (2) Where the Agency grants or amends authorisation of a practice, it shall enter in the appropriate register referred to in paragraph (1) particulars of: –

• (a) the practice registered or licensed, as the case may be;

• (b) the registered person or licensee, as the case may be;

• (c) the purpose for which the practice has been registered or licensed;

• (d) any conditions attached by the Agency to the registration or specified in the licence; and

• (e) such other particulars as the Agency considers appropriate.

• (3) A practice for which a licence or registration is granted by the Agency in accordance with paragraph (2), may be carried out in accordance with the registration or licence, as the case may be, from the date on which the particulars referred to in that subsection are entered in the register of registered practices or the register of licensed practices, as appropriate.

• (4) When a licence has been granted, no modifications to equipment or facilities, subject of that licence, shall be carried out without the prior consent of the Agency.

• (5) Practices shall not be carried out unless authorised by the Agency or exempted from the requirement for authorisation under Regulation 8(7).

Authorisation procedure

13.

13. An application for an authorisation shall be in such form and include such information as may be set out in Regulations made by the Minister under Section 30(7) of the Principal Act.

Conditions specified in a Licence

14.

14. (1) The Agency may specify conditions in a licence.

• (2) In determining the conditions to be specified in a licence, the Agency shall have regard to: –

• (a) the nature of the practice and the circumstances in which it is carried out, including any equipment used in carrying it out;

• (b) the nature of the radiation source to which the practice relates;

• (c) the levels of exposure from the radiation source to which the practice relates; and

• (d) any particular safety and security measures and safeguards that may be required for the purpose of the practice being safely and securely carried out, having regard to the circumstances in which the practice is carried out.

• (3) The Agency shall, where applicable, specify conditions: –

• (a) requiring the formal and documented implementation of the principle of optimisation; and

• (b) on the discharge of radioactive effluent in accordance with plans approved and limits established under Regulation 51.

• (4) Conditions specified in a licence by the Agency under this Regulation may include a condition that the licence shall be revoked where the Agency is of the opinion that any of those conditions has not been complied with.

• (5) The Agency may amend, including by specifying new conditions or the amendment of a practice stated to be registered, or revoke a licence.

• (6) Where the Agency has specified a condition in a licence, the undertaking shall comply with that condition.

• (7) A licence shall not be transferred.

Conditions attached to a Registration

15.

15. (1) The Agency may attach to a registration conditions which the Agency considers are appropriate to be applied generally to the registration of the practice concerned having regard to the manner in which that practice is carried out by members of the profession of which the applicant for authorisation is a member or having regard to the manner in which that practice is usually carried out by a person who is, in the opinion of the Agency, substantially similar to the applicant.

• (2) In determining the conditions to be attached to a registration, the Agency shall have regard to: –

• (a) the nature of the practice and the circumstances in which it is carried out, including any equipment used in carrying it out;

• (b) the nature of the radiation source to which the practice relates; and

• (c) the levels of exposure from the radiation source to which the practice relates.

• (3) Conditions attached to a registration by the Agency under this Regulation may include a condition that the registration shall be withdrawn where the Agency is of the opinion that any of those conditions has not been complied with.

• (4) The Agency may amend, including by attaching new conditions or the amendment of a practice stated to be registered, or withdraw a registration.

• (5) Where the Agency has attached a condition to a registration, the registered person shall comply with that condition.

• (6) A registration shall not be transferred.

Non-medical imaging practices

16.

16. (1) The Agency shall identify practices involving non-medical imaging exposure, taking into account the practices included in Schedule 5.

• (2) The undertaking shall, prior to any exposure in relation to practices involving non-medical imaging exposure: –

• (i) provide information on the exposure to the individual to be exposed; and

• (ii) seek consent from, unless otherwise provided in legislation, the individual to be exposed.

• (3)
• (a) The Agency shall establish, as appropriate, requirements for practices involving non-medical imaging exposure, including criteria for individual implementation.

• (b) For the purposes of establishing requirements under subparagraph (a), the Agency may consult with: –

• (i) occupational health services;

• (ii) professional bodies of practitioners;

• (iii) Health Information and Quality Authority;

• (iv) Health Service Executive;

• (v) Health and Safety Authority; and

• (vi) such other persons or bodies as the Agency sees fit.

• (4)
• (a) For practices involving non-medical imaging exposure using medical radiological equipment: –

• (i) the relevant requirements for medical exposure set out in the European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018 ( S.I. No. 256 of 2018 ), including those for equipment, optimisation, responsibilities, training, special protection during pregnancy and the appropriate involvement of the medical physics expert shall apply;

• (ii) where appropriate, specific protocols, consistent with the objective of the exposure and required image quality, shall be put in place; and

• (iii) where practicable, specific dose constraints shall be put in place.

• (b) Before granting authorisation in respect of practices involving non-medical imaging exposure using medical radiological equipment, the Agency shall require the undertaking to submit to it for examination and approval, as part of the application for an authorisation under Regulation 13, a detailed plan demonstrating that it meets the requirements under subparagraph (a); and

• (c) Where the Agency amends, including by attaching or specifying new conditions or amending such a practice stated to be registered or licensed, the Agency may require that the undertaking submit to it an updated plan demonstrating how it will continue to meet the requirements under subparagraph (a).

Radioactive Waste Licences

17.

17. (1) The undertaking shall be responsible for the safety and management of radioactive waste generated from a practice.

• (2) The undertaking shall regularly assess, verify and continuously improve, as far as is reasonably achievable, the safety of the radioactive waste management facility or practice in a systematic and verifiable manner. This shall be achieved through an appropriate safety assessment.

• (3) The Agency shall require, as part of the licensing of a radioactive waste management facility or a practice involving radioactive waste management, the applicant to carry out a safety assessment covering the development and operation of the practice and the development, operation and decommissioning of the facility or closure of the disposal facility as well as the post-closure phase of the disposal facility. The extent of the safety assessment shall be commensurate with the complexity of the operation and the magnitude of the hazards associated with the radioactive waste, and the facility or practice.

• (4) The Agency shall, in considering a decision to grant a licence for a radioactive waste management facility or a practice involving radioactive waste management, so as to identify and reduce uncertainties, have regard to: –

• (a) the safety in the facility or of the practice during normal operating conditions, anticipated operational occurrences and design basis accidents;

• (b) the required assurance of safety in the facility or of the practice; and

• (c) measures in place to prevent accidents and mitigate the consequences of accidents, including verification of physical barriers and the applicant’s administrative protection procedures that would have to fail before workers and members of the public would be significantly affected by ionising radiation.

• (5)
• (a) The undertaking shall establish and implement integrated management systems, including quality assurance, which give due priority to safety for overall management of radioactive waste; and

• (b) The undertaking shall report periodically to the Agency on such systems for verification in accordance with guidelines published by the Agency.

• (6) The undertaking shall make adequate provision, by way of human resources and financial security or any other equivalent means appropriate for the management of the radioactive waste in question, to fulfil their obligations under this Regulation.

• (7) The Agency shall make arrangements, as appropriate, for the education and training of its staff, as well as research and development activities to cover the needs of the national programme for radioactive waste management in order to obtain, maintain and to further develop necessary expertise and skills.

• (8) This Regulation shall not apply to waste from extractive industries which may be radioactive and which falls within the scope of Directive 2006/21/EC⁷ .

Licensing of importation and exportation of Radioactive Waste

18.

18. (1) The Agency shall not grant a licence in respect of the exportation for disposal, from the State to another Member State or third country, of radioactive waste generated in the State unless at the time of shipment an agreement, taking into account the criteria established by the European Commission in accordance with Article 16(2) of Directive 2006/117/EURATOM ⁸ on the supervision and control of shipments of radioactive waste and spent fuel, has entered into force between the State and that other Member State or third country to use a disposal facility in that other Member State or third country.

• (2) The Agency shall not grant a licence in respect of the importation for disposal in the State of radioactive waste generated in another Member State or a third country, unless at the time of shipment an agreement, taking into account the criteria established by the Commission in accordance with Article 16(2) of Directive 2006/117/EURATOM, has entered into force between the State and that other Member State or third country to use a disposal facility in the State.

• (3) Paragraphs (1) and (2) do not apply to practices involving repatriation of disused sealed sources to a supplier or manufacturer.

• (4) Paragraph (1) shall not affect the right of an undertaking in the State to return the radioactive waste after treatment or processing, to its country of origin, where: –

• (a) radioactive waste is to be shipped to the undertaking for treatment or processing; or

• (b) other material is to be shipped to the undertaking with the purpose of recovering the radioactive waste.

• (5) Prior to a shipment to a third country, the Agency shall inform the European Commission of the content of any such agreement and take reasonable measures to be assured that: –

• (a) the country of destination has concluded an agreement with the Community covering radioactive waste management or is a party to the Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management;

• (b) the country of destination has radioactive waste management and disposal programmes with objectives representing a high level of safety equivalent to those established by the Waste Directive; and

• (c) the disposal facility in the country of destination is authorised for the radioactive waste to be shipped, is operating prior to the shipment, and is managed in accordance with the requirements set down in the radioactive waste management and disposal programme of that country of destination.

Release from regulatory control

19.

19. (1) The disposal, recycling or reuse of radioactive materials arising from any authorised practice shall be subject to authorisation.

• (2) Materials for disposal, recycling or reuse may be released from regulatory control provided that the activity concentrations: –

• (a) for solid material do not exceed the clearance levels set out in Table A of Schedule 7; 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 shall be established by the Agency.

• (3) For the clearance of materials containing naturally-occurring radionuclides, where these result from authorised practices in which natural radionuclides are processed for their radioactive, fissile or fertile properties, the clearance levels comply with the dose criteria for clearance of materials containing artificial radionuclides.

• (4) The deliberate dilution of radioactive materials for the purpose of them being released from regulatory control is hereby prohibited. The mixing of materials that takes place in normal operations where radioactivity is not a consideration is not subject to this prohibition. The Agency may authorise, in specific circumstances, the mixing of radioactive and non-radioactive materials for the purposes of re-use or recycling.

Part 3 – SYSTEM OF RADIATION PROTECTION

Section 1 – Tools for optimisation

Dose constraints for occupational and public exposure

20.

20. (1) The Agency shall ensure that, where appropriate, dose constraints are established by undertakings and employers for the purpose of prospective optimisation of protection: –

• (a) for occupational exposure, the dose constraint shall be established as an operational tool for optimisation by the undertaking: –

• (i) in the case of outside workers the dose constraint shall be established in cooperation between the employer and the undertaking; and

• (ii) in all cases the dose constraint shall be established in accordance with guidelines issued by the Agency.

• (b) for public exposure, the dose constraint shall be set by the undertaking for the individual dose that members of the public receive from the planned operation of a specified radiation source in accordance with guidelines issued by the Agency.

• (2) Dose constraints shall be established in terms of individual effective or equivalent doses over a defined appropriate time period.

• (3) For practices involving non-medical imaging exposure justified under Regulation 5(1)(b) and not using medical radiological equipment, dose constraints shall be significantly below the dose limit for members of the public under Regulation 27 in accordance with guidelines issued by the Agency.

Reference levels

21.

21. (1) The Agency shall establish reference levels to apply in emergency and existing exposure situations taking into account the range of reference levels set out in Schedule 1. Optimisation of protection shall give priority to exposures above the reference level and shall continue to be implemented below the reference level.

• (2) In a nuclear or radiological emergency exposure situation, these reference levels shall be considered in optimising the protection of members of the public, taking account of both radiological protection and socio-economic criteria.

Section 2 - Dose limitation

Age limit for exposed workers

22.

22. Subject to Regulation 26(2), persons under 18 years of age may not be assigned to any work which would result in them meeting the definition of an exposed worker.

Dose limits for occupational exposure

23.

23. (1) Without prejudice to Regulation 25, the undertaking, and in the case of an outside worker, the employer, shall ensure that dose limits for occupational exposure apply to the sum of annual occupational exposures of a worker from all authorised practices, occupational exposure to radon in workplaces requiring notification in accordance with Regulation 66, and other occupational exposure from existing exposure situations in accordance with Parts 3, 7 and 8 of these Regulations. For emergency occupational exposure Regulation 62 shall apply.

• (2) The limit on effective dose for occupational exposure shall be 20 mSv in any single year. In special circumstances or for certain exposure situations where the Agency is satisfied that a dose in excess of the annual limit is appropriate, the Agency may authorise a higher effective dose of up to 50 mSv in a single year, provided that the average annual dose over any 5 consecutive years, including the years for which the limit has been exceeded, does not exceed 20 mSv.

• (3) In addition to the limits on effective dose laid down in paragraph (2), 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 single year or 100 mSv in any 5 consecutive years subject to a maximum dose of 50 mSv in a single year;

• (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; and

• (c) the limit on the equivalent dose for the extremities shall be 500 mSv in a year.

• (4) In relation to paragraph (3), the undertaking, and in the case of an outside worker, the employer, shall comply with such guidelines as the Agency may issue in relation to the appropriate procedures to be followed in assessing occupational exposures.

Protection of pregnant and breastfeeding workers

24.

24. (1) As soon as a pregnant worker informs the undertaking or, in the case of an outside worker, the employer, of the pregnancy, the undertaking, and the employer, shall ensure that the protection of the unborn child is comparable with that provided for members of the public.

• (2) The undertaking, and the employer, shall ensure that the employment conditions for the pregnant worker are 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.

• (3) As soon as workers inform the undertaking, or in case of outside workers, the employer, that they are breastfeeding an infant, they shall not be employed in work involving a significant risk of intake of radionuclides or of bodily contamination.

Specially authorised exposures

25.

25. (1) In exceptional circumstances evaluated case by case, excluding radiological emergencies, the Agency may, where a specific operation so requires, authorise individual occupational exposures of identified workers exceeding the dose limits specified in Regulation 23, provided that such exposures are limited in time, confined to certain working areas and are within maximum exposure levels defined for the particular case by the Agency.

• (2) The undertaking shall submit an application to the Agency carefully justifying the proposed exposure and providing information about the risks involved and precautions to be taken.

• (3) The undertaking shall permit only Category A workers or spacecraft crew to be subject to exposures authorised under this Regulation.

• (4) Apprentices, students, pregnant workers and, if there is a risk of intake or bodily contamination, breast-feeding workers shall be excluded from such exposures.

• (5) Before an exposure authorised under this Regulation takes place, the undertaking shall justify such exposures and thoroughly discuss them with the workers concerned, their representatives, the occupational health service and the radiation protection adviser.

• (6) The undertaking shall ensure that information about the risks involved and the precautions to be taken during the operation are provided to the relevant workers in advance.

• (7) The undertaking shall obtain the worker’s consent in writing.

• (8) The undertaking shall ensure that all doses relating to such exposures are separately recorded in the medical record referred to in Regulation 47 and in the individual dose record referred to in Regulation 42.

• (9) An undertaking shall not, without the agreement of the workers, exclude them from their usual occupation or relocate them on the grounds that the workers have exceeded a dose limit as a result of an exposure authorised under this Regulation.

• (10) The Agency shall ensure that the exposure of spacecraft crew above occupational dose limits is managed as a specially authorised exposure.

Dose Limits for apprentices and students

26.

26. (1) The dose limits for apprentices 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 Regulation 23.

• (2) The limit on the effective dose for apprentices and 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 in a year.

• (3) In addition to paragraph (2): –

• (a) the limit on the equivalent dose for the lens of the eye of an apprentice or student referred to in that paragraph shall be 15 mSv in a year;

• (b) the limit on the equivalent dose for the skin of an apprentice or student referred to in that paragraph shall be 150 mSv in a year, averaged over any area of 1 cm² of skin, regardless of the area exposed; and

• (c) the limit on the equivalent dose for the extremities of an apprentice or student referred to in that paragraph shall be 150 mSv in a year.

• (4) The dose limits for apprentices and students to whom paragraphs (1), (2) and (3) do not apply shall be the same as the dose limits for members of the public as specified in Regulation 27.

Dose Limits for public exposure

27.

27. (1) The dose limits for public exposure shall apply to the sum of annual exposures of a member of the public resulting from all authorised practices.