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Radiation Act 27.3.1991/59227.3.1991

Amendments up to and including 624/2011.

Chapter 1 General provisions

Section 1 Purpose and scope of the Act

The purpose of this Act is to prevent and limit health hazards and other detrimental effects of radiation.

The Act covers the use of radiation and other practices that involve or may involve exposure to radiation hazardous to human health.

Section 2 General principles

To be considered acceptable, the use of radiation and practices involving exposure to radiation shall meet the following criteria:

1. The benefits derived from the practice shall exceed the detriment it causes (principle of justification),

2. The practice shall be arranged so that the resulting exposure to radiation hazardous to health is kept as low as is reasonably achievable (principle of optimization),

3. No person shall be exposed to radiation exceeding the maximum values prescribed by Decree (principle of limitation).

Section 3 Relation to other statutes

The use of nuclear energy is prescribed by the Nuclear Energy Act (990/1987). The provisions of Section 2 and chapter 9 of this Act shall, however, also apply to the use of nuclear energy.

Radiation exposure due to natural radiation in mines shall be determined on the basis of this Act, which shall also impose requirements for radiation safety in mining. Other aspects of safety in mines and regulatory control thereof shall be prescribed in the Mining Act (621/2011). (10.6.2011/624)

Provisions of occupational safety and the protection of workers are prescribed elsewhere. (23.8.2002/744)

Section 4 Application in the Defence Forces and Frontier Guard

Exceptions to the application of this Act may be stipulated by Decree for the Defence Forces and Frontier Guard where such exceptions are warranted by important reasons of national defence or the guarding of national borders.

Chapter 2 Authorities

Section 5 Division of duties between ministries

Supreme authority in supervising compliance with this Act shall be vested in the Ministry of Social Affairs and Health in matters concerning:

1. General evaluation of the health hazards caused by radiation,

2. Evaluation of the need for measures to limit exposure to radiation, and imposition of requirements on such measures, and

3. Requirements for monitoring the radiation exposure of workers and other persons exposed to radiation.

Supreme authority and executive direction on the supervision of practices involving exposure to radiation shall be vested in the Ministry of Social Affairs and Health. In matters concerning the following, however, supreme authority and executive direction shall be vested in the Ministry of Employment and the Economy:

1.?Use of nuclear energy as referred to in the Nuclear Energy Act, or

2.?Commercial manufacturing and trading in, and importing and exporting of radiation sources.

(10.6.2011/624)

Section 6 (27.11.1992/1102) Regulatory and supervisory authorities

Compliance with this Act and with the provisions and regulations issued pursuant thereto shall be supervised by the Radiation and Nuclear Safety Authority (STUK). Medical uses of radiation shall be directed and supervised by STUK as an agency of the Ministry of Social Affairs and Health, as stipulated in sections 38 and 41 below or elsewhere.

Section 7 Advisory Board for Radiation Safety

On the presentation of the Ministry of Social Affairs and Health, the Council of State shall appoint an Advisory Board for Radiation Safety a for a term of three years at a time to serve as a co-ordinating and expert body to consider issues of principle and matters of far-reaching consequence in the field of radiation safety.

The composition and duties of the Advisory Board shall be prescribed by Decree.

Chapter 3 Definitions

Section 8 Radiation

For the purposes of this Act, the term:

1. Radiation shall denote ionizing and non-ionizing radiation,

2. Ionizing radiation shall denote radiation capable of producing ions in a medium,

3. Non-ionizing radiation shall denote ultraviolet radiation, visible light, infrared radiation, radio-frequency radiation, and low-frequency and static electric and magnetic fields,

4. Natural radiation shall denote ionizing radiation originating in space, or from radioactive substances occurring in nature and not used as radiation sources.

The medical use of ultrasound shall be governed by the provisions on the supervision of non-ionizing radiation stipulated in this Act.

Section 9 Radiation appliances and radioactive substances

For the purposes of this Act, the term:

1. Radiation appliance shall denote an appliance producing radiation electrically or containing radioactive substance,

2. Radioactive substance shall denote substance that decays spontaneously and emits ionizing radiation,

3. Radiation sources shall denote radiation appliances and radioactive substances.

If necessary, STUK shall determine in individual cases whether an appliance is to be considered a radiation appliance or whether a substance is to be considered a radioactive substance.

Section 10 Radioactive waste

The term radioactive waste shall denote radioactive substances, and equipment, goods and materials contaminated by radioactive substances, that have no use and must be rendered harmless due to their radioactivity. Radioactive substances and radiation appliances containing radioactive substance, the owner of which cannot be found, shall also be regarded as radioactive waste.

The expression rendering radioactive waste harmless shall refer to any measure needed to treat, isolate or dispose of the waste, or to restrict its use so that it does not endanger human health or the environment.

The expression recognised installation shall refer to an enterprise registered in Finland or to some other responsible party whose field of activity includes rendering radioactive waste harmless and that has a safety license for the said operation. (22.12.2005/1179)

Section 11 Radiation practices

The term radiation practices shall denote:

1. the use of radiation,

2. operations or circumstances in which human exposure to natural radiation causes or may cause a health hazard.

The expression use of radiation shall refer to the use and manufacture of, and trade in radiation sources, and to related activities such as possession, safekeeping, servicing, repairs, installation, import, export, storage, transport and rendering radioactive waste harmless.

If necessary, STUK shall decide in individual cases whether an operation is to be considered a radiation practice.

Section 12 (23.12.1998/1142) Radiation work

The term radiation work shall refer to work or to a task involving the use of radiation or nuclear energy, in which the worker may be exposed to radiation to such a degree that monitoring of radiation exposure must be arranged at the workplace.

The expression approved dosimetric service shall refer to an operational unit or service provider that is responsible for measuring and determining the personal radiation doses of workers as part of radiation exposure monitoring, and which has been approved by the Radiation and Nuclear Safety Authority – STUK in the manner prescribed in Section 32 of this Act. (22.12.2005/1179)

Section 13 Responsible party

The expression responsible party shall denote:

1. The licensee referred to in chapter 5,

2. Any business or sole trader, enterprise, corporation, foundation or institution which uses radiation sources in its operations,

3. Any employer or self-employed person engaged in radiation practices.

Chapter 4 General obligations of a responsible party

Section 14 General duty of care

A responsible party shall organize a practice to meet the requirements prescribed in this Act, and so that the risk of an occurrence leading to exceptional exposure to radiation is adequately eliminated. The responsible party shall be required to take such measures to improve radiation safety as are justifiable with respect to their nature, costs and positive impact on radiation safety.

In matters concerning the safety of operations, the responsible party shall be required to ensure that it possesses the expertise required with respect to the nature and extent of the operations.

The appointment of the radiation safety officer referred to in Section 18 shall not diminish the obligations of the responsible party.

Section 14 a (22.12.2005/1179) Duty of training

The responsible party shall have a duty to organise, in accordance with the nature and scope of operations, systematic training of persons involved in the use of radiation sources. In addition to the knowledge and skills that are required for the use of radiation sources, this training shall emphasise safety and quality control in order to forestall abnormal incidents.

Section 14 b (22.12.2005/1179) Duty of accounting and notification

The responsible party shall maintain records of the radiation sources containing radioactive substances for which it is responsible. The accounting shall be kept continuously up to date.

Receipt and transfers of radiation sources containing radioactive substances and other accountable actions pertaining thereto shall be notified to a register maintained by the Radiation and Nuclear Safety Authority – STUK. The said notification shall be governed by current or future provisions of a Decree of the Council of State.

The Radiation and Nuclear Safety Authority - STUK shall issue more detailed instructions on accounting and notification to the register.

Section 15 Obligation to provide information

A responsible party assigning a radiation source to another party shall be required, at the time of the said assignment, to furnish the recipient with all information in its possession that is significant for the safe use of radiation. A responsible party is correspondingly required to supply the said information to a new responsible party when the practice is transferred.

Chapter 5 Licensing system

Section 16 Safety licence and conditions for granting

The use of radiation shall be subject to licence (safety licence, unless otherwise stipulated below. Safety licences shall be granted by STUK upon application.

A safety licence may be granted if the use of radiation meets the requirements prescribed in Section 2 and the application demonstrates with sufficient reliability that

1. the purpose of using the radiation, the place of use, the radiation sources and related facilities,

2. the user`s organization, and

3. the arrangements for handling any radioactive waste that may arise from the operations

are such that the radiation may be safely used.

A safety licence may include conditions necessary to ensure safety. STUK may alter the conditions of a licence after it has been granted where this is warranted by justified reasons in order to ensure safety.

More detailed provisions on safety licence application procedures shall be issued by Decree.

Section 17 Licence-free operations

No safety licence shall be required:

1. for the use of non-ionizing radiation,

2. for the use of a radiation appliance used as a consumer product,

3. for the use of a radiation appliance that has been exempted from safety licensing owing to its safety properties, (22.12.1994/1334)

4. for the use of a radiation source requiring no special supervision in order to ensure radiation safety, because the radiation exposure caused thereby is so minor, (22.12.1994/1334)

5. for the manufacture of or trade in radiation appliances producing radiation electrically and used as consumer products, and for any operations pertaining to the said manufacture or trade,

6. for the export of radiation sources not containing radioactive substance, and (22.12.1994/1334)

7. for the transport of radioactive substances.

In addition to the practices referred to at points 3 and 4 of paragraph 1 hereof, STUK may exempt from safety licensing other kinds of use of radiation if it may be ascertained with sufficient reliability that the use of radiation will cause no detriment or danger to health. (22.12.1994/1334)

Licence-free use of radiation may be ordered notifiable to STUK. (22.12.1994/1334)

Section 18 Organization description

An application for a safety licence shall be supplemented with a description of the radiation user's organization (an organization description), specifying the name of the radiation safety officer responsible for safety in the use of radiation.

Having regard to the nature and scope of use of the radiation and to conditions at the place of use, the organization description shall also provide sufficient information concerning:

1. the competence of the persons participating in the use of radiation,

2. the duties and division of responsibility pertinent to the safe use of radiation,

3. other arrangements to ensure safety at the place of use of radiation.

STUK shall stipulate the qualifications required of a radiation safety officer and of other persons working in the user's organization, and shall investigate compliance with the said stipulations.

Section 19 Furnishing security

To ensure that the costs incurred in rendering radioactive waste harmless and in performing any necessary environmental decontamination measures are met, the holder of a safety licence shall furnish the security stipulated by Decree, when:

1. the licence is granted for extensive manufacture of, use of, or trade in radioactive substances or radiation sources containing such substances, or

2. the operations produce, or may produce radioactive waste that cannot be rendered harmless without considerable expenses.

The provisions of paragraph 1 hereof shall not apply to the State, municipalities, intercommunal organizations or public corporations.

Section 20 Validity of a safety licence

A safety licence may be granted until further notice or for a fixed period.

The licence shall be recorded as having expired after the licensee has notified in writing that the use of radiation has been discontinued, and has demonstrated that it has in an acceptable manner relinquished or rendered harmless the radioactive substances in its possession.

STUK may cancel a licence if:

1. some condition of issuing the licence is no longer met, or

2. the terms of the licence or the orders issued by the regulatory authority pursuant to this Act have been infringed so as to substantially endanger safety in the use of radiation.

A licence shall expire when the licensee dies or loses legal capacity, or if a licensee who is a physician, dentist, veterinary surgeon or other medical practitioner loses the right to practise the said profession. The radiation safety officer shall notify STUK of such a development without delay.

Chapter 6 Product safety and measurements of radiation (22.12.1994/1334)

Section 21 (22.12.1994/1334) Conformity of products to requirements

Anyone who imports, trades in, transfers to another party or otherwise places on the market radiation appliances, radioactive substances or materials containing radioactive substances, or equipment or other products (product) pertaining to safety of radiation practice, shall be able to demonstrate that the said products meet the safety requirements pertaining thereto.

An importer, manufacturer or seller may be required to furnish STUK with the information needed for the regulatory control of safety of products which they have placed on the market.

Section 22 (22.12.1994/1334) Inspection of products

The regulatory authority may inspect a product in order to verify that it complies with the requirements. If safety-related defects are found in the said inspection, then the importer or other party placing the product on the market shall be required to compensate the authority for the costs incurred in the inspection.

A prohibition on the sale or transfer of defective or deficient products is prescribed in Section 56.

Section 23 (22.12.1994/1334) Radiation measurements

The measurements required for evaluating radiation exposure and ensuring radiation safety shall be made using a method of proven reliability. Radiation meters and equipment used for radiation measurements shall be properly calibrated.

It shall be the duty of STUK to maintain the metrological standards necessary to ensure reliable radiation measurements.

Chapter 7 Radiation appliances

Section 24 General requirements

A radiation appliance, its place of use and accessories and associated equipment shall be such as to enable the radiation appliance to be used safely.

STUK shall stipulate the safety requirements to be considered in the design of buildings, prefabricated units and structures affecting the safe use of radiation appliances.

Section 25 Installation, repair and servicing

Radiation appliances may be installed, repaired and serviced only by persons with the necessary skill and expertise. On completing an installation, repair or servicing assignment, the person who has done the work shall ensure that the appliance functions faultlessly.

A safety licence shall be required for installation, repair or servicing, when the work involves:

1. an appliance emitting ionizing radiation that is used for medical purposes,

2. a radiation appliance, the operation of which requires a safety licence, or

3. a radiation appliance exempted from a safety licence, the installation, repair or servicing of which has been separately stipulated to require a licence. (22.12.1994/1334)

Repair or servicing which does not involve components affecting the safety of the appliance, such as components generating radiation or shielding from it, or other comparable components may be performed without a safety licence.

Chapter 8 Radioactive substances

Section 26 General requirements

Radioactive substances shall be used and stored only in places in which they can be used safely and where they are prevented from falling into the hands of unauthorized persons.

The safety requirements to be considered when designing laboratory and other premises, and affecting safety in the use of radioactive substances, shall be stipulated by STUK.

Section 27 Restrictions on use

Mixing or combining radioactive substances with consumer products which are not used as radiation sources referred to in this Act is permissible only on special, justifiable grounds, and with a licence granted by STUK.

The use of radioactive substances in foodstuffs, cosmetics, toys and corresponding consumer products is prohibited.

The import and export of the consumer products referred to in paragraph 1 hereof shall be permitted solely under a licence granted by STUK pursuant to the said paragraph. The import and export of consumer products contrary to paragraph 2 hereof shall be prohibited. (23.12.1998/1142)

Section 28 (22.12.1994/1334) Transferor's obligations

When transferring radioactive substances the use of which has not been exempted from a safety licence, the transferor shall ensure that the transferee has a safety licence entitling it to possess radioactive substances.

Anyone who conveys radioactive substances to a Member State of the European Union shall ensure in advance that the consignee meets the statutory requirements of the European Communities and of the receiving Member State governing the possession, use and disposal of radioactive substances. More detailed provisions on the export of radioactive substances shall be issued by Decree. (22.12.1994/1334)

Section 29 Transport of radioactive substances

A licensee who commissions the transport of radioactive substances or imports such substances shall be required to ensure that:

1. the transport package meets the safety requirements imposed on it,

2. the mode of transport used is appropriate from a safety perspective,

3. the carrier has all the information and instructions necessary for safe transport, and

4. proper advance notification has been made of the transport where this is prescribed or stipulated pursuant to this Act or to some other Act.

Section 30 Licensee’s liability for damage in transport

A licensee neglecting the obligations prescribed in Section 29 hereof shall be liable to compensate for any damage occurring during the transport of radioactive substances.

If it is shown that the damage was substantially due to causes other than the negligence of the licensee, then compensation for damage shall be determined according to the Damages Act (412/1974).

If the negligence of the licensee was minor, and cannot be regarded as having contributed to the occurrence of the damage, a court may discharge the licensee from the liability prescribed in paragraph 1 hereof.

For the purposes of this section, the term “licensee” shall also denote a party obliged to apply for a safety licence.

Section 31 Compliance with other statutes

In addition to the provisions of this Act, the provisions and regulations governing the transportation of hazardous substances shall also be applicable when radioactive substances are transported.

Chapter 8 A (22.12.2005/1179) High-activity sealed sources

Section 31 a (22.12.2005/1179) Definitions

The term Sealed Sources Directive shall denote European Union Council Directive no. 2003/122/EURATOM of 22 December 2003 on the control of high-activity sealed radioactive sources and orphan sources.

The term high-activity sealed source (hereinafter referred to as a source) shall denote a radiation source containing a radionuclide the activity of which at the time of manufacture, or if the activity at time of manufacture is not known, at the time when the source is first placed on the market, is not less than the activity level specified in Annex 1 of the Sealed Sources Directive, and the structure of which under normal conditions of use prevents the spread of radioactive substances to the environment.

Section 31 b (22.12.2005/1179) Application for and issuing of safety licenses

Accounts satisfying the requirements of sections 16 and 18 of this Act shall be appended to the application when requesting a safety license for the use of a high-activity sealed source. Accounts of the following matters shall be provided in particular:

1. sources and their shields, and equipment associated with the use of sources;

2. the quality control system pertaining to use and handling of sources and the procedures used in quality assurance;

3. any maintenance of sources, shields and equipment associated with the use of sources;

4. procedures in emergencies and in situations in which safety is significantly compromised; and

5. rendering harmless of any disused sources, including the arrangements for their return to the manufacturer or supplier, or their surrender to a recognised installation.

A license may be issued for use of a source of the kind referred to in Section 31 f only if a security has been lodged in accordance with Section 19 of this Act.

When issuing a safety license the Radiation and Nuclear Safety Authority – STUK shall impose the conditions that are necessary to satisfy the safety requirements.

Section 31 c (22.12.2005/1179) Use of sources

When using high-activity sealed sources the responsible party shall take particular care in the following respects:

1. ensuring source integrity through appropriate and regular leak tests;

2. inspecting sources and source locations regularly;

3. protecting sources from illegal activities, loss or damage;

4. taking available measures to ensure or restore secure conditions after a source has been damaged, lost or subject to illegal activity; and

5. removing disused sources by returning them to their manufacturer or supplier, to a recognised installation, or to some other appropriately licensed responsible party.

Section 31 d (22.12.2005/1179) Identification of sources

Every high-activity sealed source shall be furnished with a unique numerical identifier, which shall be marked in an optimally permanent manner on the source itself, and by engraving or stamping on the source shield.

The identification of a source shall be the duty of its manufacturer.

The importer of a high-activity sealed source shall ensure that the source is identified in accordance with the requirements prescribed in paragraph 1. Importation of unidentified sources shall be prohibited.

Section 31 e (22.12.2005/1179) Export and import outside of the European Union

The prior approval of the Radiation and Nuclear Safety Authority – STUK shall be sought for each consignment whenever a high-activity source or sources are exported to or imported from a country outside of the European Union. The detailed approval procedure shall be prescribed by Decree of the Council of State.

High-activity sealed sources shall not be exported to a country with inadequate technical, legislative or administrative facilities to ensure the care or safe use of the source.

Section 31 f (22.12.2005/1179) Lodging of security

The responsible party shall lodge a security in the manner prescribed in Section 19 of this Act if the activity of a high-activity sealed source exceeds the activity level specified in Annex 1 of the sealed sources directive by a factor of 100 times or more. No security need be lodged, however, for a source with a half-life of less than 150 days.

The size of the security shall be separately determined by STUK for each source. The security shall comprise a fixed standard charge and a source-specific surcharge based on the type of radioactive substance contained in the source and on the activity of the source.

The security shall be rounded off to the nearest thousand euros. The security shall consist of a bank guarantee, credit insurance or a security of comparable reliability prescribed by Decree of the Council of State.

Section 31 g (22.12.2005/1179) Authority to issue further provisions

More detailed provisions shall prescribed by Decree of the Council of State on the following matters:

1. accompanying details of high-activity sealed sources and their identities, and furnishing of sources with radiation hazard warning signs;

2. the duty of the responsible party to report to the regulatory authority all high-activity sealed sources that are under its care;

3. necessary government activities to render radioactive waste harmless where no recognised installation of the kind referred to in paragraph 3 of Section 10 as yet exists; and

4. the grounds for determining the security referred to in Section 31 f.

Revision of the grounds for determining the security in the event of a substantial change in circumstances may also be prescribed by Decree of the Council of State. If necessary the said Decree shall also prescribe the time limit within which any securities already lodged must be supplemented to satisfy the revised grounds.

The radionuclide-specific activity levels under Annex 1 of the Sealed Sources Directive shall be published by the Radiation and Nuclear Safety Authority – STUK in its regulations series.

Chapter 9 (23.12.1998/1142) Radiation work

Section 32 (23.12.1998/1142) Protection of workers

The responsible party shall plan and implement protection of workers according to the following principles:

1. the radiation exposure to which workers are subjected and the factors affecting this exposure shall be investigated in advance, also having regard to exceptional working conditions,

2. working areas shall, where necessary, be classified as controlled areas and supervised areas, and

3. workers who must be individually monitored for radiation exposure shall be classified in a separate group (category A).

The principles for classifying workers and monitoring radiation exposure shall be stipulated by Decree. STUK shall specify more detailed requirements and issue instructions for the protection of workers and the monitoring of radiation exposure.

Section 32 a (22.12.2005/1179) Dosimetric service approval

The prior approval of the Radiation and Nuclear Safety Authority – STUK shall be sought for the dosimetric service referred to in Section 12 before operations begin.

When assessing the acceptability of a dosimetric service particular attention shall be paid to the suitability of measuring procedures, to the competence of measuring personnel and to the quality system employed in operational control. Dosimetric services shall be approved for a specified period not exceeding five years at a time.

Regulatory control of an approved dosimetric service shall be governed by the provisions of Section 53 of this Act.

Section 33 (23.12.1998/1142) Medical surveillance

Medical surveillance of workers engaged in radiation work shall be governed by the provisions of the Occupational Health Care Act (743/1978) and by the regulations issued pursuant to the said Act concerning health examinations for persons engaged in work involving special health risks. A medical practitioner (responsible practitioner) shall also be appointed for the medical surveillance of category A workers. The required qualifications of the responsible practitioner shall be stipulated by Decree. The duties of the responsible practitioner shall include in particular:

1. to ascertain the fitness for work of a worker to be assigned to category A work before the work begins and in the course of work at least once a year, and

2. to issue a statement indicating subsequent conditions for continuing the radiation work in question or corresponding duties if the worker’s radiation exposure is observed or is suspected to have exceeded the prescribed maximum value.

The responsible party shall ensure that the responsible practitioner receives all information and reports on working conditions as are necessary to perform the assigned duties.

Section 33 a (23.12.1998/1142) Prohibition on assigning radiation work

A worker who is unfit for category A due to health reasons may neither be placed in this category nor assigned to corresponding duties.

Section 33 b (23.12.1998/1142) Worker’s rights

A worker shall be given, upon request, a written certificate of the responsible practitioner concerning the worker’s fitness for category A. If the responsible party assigns the worker for transfer from category A work to other duties for health reasons, then the worker shall also be given, upon request, a written certificate attesting thereto.

A worker shall be entitled to submit to STUK for consideration any matter referred to in paragraph 1 hereof which concerns the said worker. The responsible party shall inform the worker of this right.

STUK shall consider the said matter without delay. No amendment to the decision of STUK may be sought by appeal.

Section 33 c (23.12.1998/1142) Exposure exceeding a maximum value

If an assessment of exposure conditions shows that a worker has probably received radiation exposure exceeding a maximum prescribed value, then the worker shall be obliged to submit to an examination necessary to determine the exposure and its effects.

No worker may be dismissed on the grounds that the worker has received radiation exposure exceeding a maximum prescribed value.

Section 34 (23.12.1998/1142) Dose Register

STUK shall keep a file on the radiation exposure of workers engaged in radiation work (Dose Register) in order to oversee implementation of the principles of limitation and optimization referred to in Section 2 hereof. The individual particulars of each worker and information on the type of radiation work, the methods used to monitor radiation exposure, factors affecting the exposure and the results of exposure monitoring shall be recorded in the Dose Register.

The responsible party shall ensure that the data to be registered and the results of exposure monitoring are submitted to STUK, itemised in the manner specified by the latter so that the radiation exposure of each worker can be determined.

Information on the worker’s radiation exposure may be submitted, without the consent of the worker, to the responsible practitioner referred to in Section 33 and to the responsible party for the practice causing the exposure. Information may be submitted to a responsible party in a Member State of the European Union when this is necessary to fulfil the obligations of the employer concerning monitoring of radiation exposure.

The provisions of Section 34 b concerning the period for preserving data on a worker’s health shall govern the archiving period for the individual particulars of a worker in the Dose Register.

Section 34 a (23.12.1998/1142) Medical Records

A record (Medical Record) of data collected in medical surveillance shall be arranged for each category A worker for the purpose of monitoring the worker’s state of health. The Medical Record shall include the information on the worker’s previous duties and service which is necessary for medical surveillance purposes, together with the results of monitoring of the worker’s exposure.

The information in the Medical Record may be submitted to STUK without the worker’s consent. A responsible party for a practice causing exposure to radiation shall be provided with the information necessary to perform the obligations of the responsible party prescribed in this Act.

It shall be the duty of the responsible practitioner to ensure that the Medical Record is properly arranged and kept up to date. If the responsible practitioner changes, then the Medical Record shall be transferred to the responsible practitioner's successor.

Section 34 b (23.12.1998/1142) Processing and safekeeping of health data

Information in the Medical Record is to be treated as confidential.

The Medical Record is to be kept up to date continuously for as long as the worker is a category A worker. Thereafter the said file shall be kept until the worker attains or would have attained the age of 75 years. In all cases the file must be preserved until 30 years have elapsed from the termination of the radiation work.

Section 35 (23.12.1998/1142) Radiation work performed abroad

A Finnish employer who has hired a Finnish worker to perform radiation work abroad shall be responsible for ensuring that information on the worker’s radiation exposure is notified to the Dose Register.

Section 36 (23.12.1998/1142) Worker training and instructions

Workers shall be provided with training and instructions for their duties appropriate to the kind of work and to conditions at the workplace. Particular attention shall be paid to information on the health hazards of radiation and on safety-enhancing work procedures in order to prevent unnecessary exposure to radiation and events leading to exceptional exposure thereto.

Workers shall comply with the instructions issued, and shall also otherwise attend to their own radiation safety and to that of others.

Section 37 (23.12.1998/1142) Age limits

A person performing radiation work shall have attained the age of 18 years. Persons younger than this, but not less than 16 years of age, may participate in the use of radiation sources insofar as this is necessary for their vocational training.

Section 37 a (23.12.1998/1142) Responsibility for workers of an outside undertaking

The obligation of the responsible party to arrange for the protection of workers, monitoring of exposure to radiation and medical surveillance according to the provisions of this chapter shall also apply to those workers and self-employed persons who participate in radiation work assigned by the responsible party without entering the service thereof.

An outside undertaking shall be responsible, as an employer, for ensuring that its workers receive training and guidance for their work pursuant to the provisions of Section 36. The employer shall also ensure that the protection of workers, monitoring of exposure to radiation and medical surveillance are properly arranged.

Chapter 10 (23.12.1998/1142) Medical uses of radiation

Section 38 (23.12.1998/1142) Grounds for the medical use of radiation

The medical use of radiation shall denote any practice in which ionizing radiation is deliberately targeted at the human body or part thereof for the following purposes:

1. to examine or treat an illness, or

2. for medical research or some other medical procedure.

The maximum values for radiation exposure under this Act shall not apply to the radiation exposure received by a person being examined or treated. The exposure shall be medically justified and shall be limited to the amount considered necessary for achieving the intended result of the examination or treatment.

Section 39 (23.12.1998/1142) Clinical responsibility

The physician bearing clinical responsibility for a procedure causing exposure to radiation shall be responsible for the medical justification and optimization of the procedure, and for participating in the clinical assessment of the results of the procedure. Clinical responsibility shall require competence to assume clinical responsibility pertaining to the type of procedure involved.

Clinical responsibility shall include ensuring that the following matters are seen to in an appropriate manner before performing the procedure:

1. obtaining essential data on previous examinations and treatments,

2. issuing the special instructions necessary to optimize the procedure to the person performing the procedure,

3. providing information to the patient or other concerned party on possible health detriments caused by exposure to radiation.

The responsible party shall ensure that all procedures pertaining to assigning and transferring clinical responsibility are clearly arranged.

Section 39 a (23.12.1998/1142) Referrals to procedures

A physician issuing a referral to a procedure involving exposure to radiation shall contribute to assessing the justification for the said procedure. For this purpose the physician shall obtain the available essential information on previous examinations and treatments and, where assessing the justification for the procedure so requires and as necessary, the physician shall consult specialists before issuing the referral.

Section 39 b (23.12.1998/1142) Performance of a procedure

A person performing a procedure involving exposure to radiation shall possess the competence and experience required for the type of procedure. The responsible party shall also ensure that the responsibilities and measures pertaining to performance of the medical procedures are clearly arranged.

Before targeting radiation at a human being, a person performing a procedure shall have a special obligation to ensure that:

1. the safety and shielding arrangements of the radiation source are in proper condition and the equipment to be used functions faultlessly,

2. the patient is properly protected and radiation exposure is limited to the parts of the body that are intended to be irradiated, and

3. any radioactive substance being administered to the patient has been properly checked.

Section 39 c (23.12.1998/1142) Clinical audit

The responsible party shall arrange a systematic assessment of the medical use of radiation (clinical audit), in which:

1. a review is made of examination and treatment procedures followed, of radiation exposures and of the results of examination and treatment,

2. these are compared with known good examination and treatment procedures, and

3. measures considered necessary are proposed for improving practices and preventing unwarranted exposure to radiation.

Section 40 (23.12.1998/1142) Quality assurance

The responsible party shall implement planned and systematic measures to ensure that the radiation sources and accessories and associated equipment are in good condition and that the instructions and procedures concerning their use are appropriate.

Section 41 (23.12.1998/1142) Authority to issue further provisions

More detailed provisions concerning the grounds and requirements for the medical use of radiation shall be issued by an order of the Ministry of Social Affairs and Health. An order of the Ministry of Social Affairs and Health shall provide in particular for:

1. screening examinations in which radiation is targeted at persons without symptoms,

2. the use of radiation in medical procedures in which radiation is targeted at a person whose health is not expected to benefit directly from the exposure,

3. requirements for the training in radiation protection which is necessary for those bearing clinical responsibility,

4. the procedures to be used in clinical auditing and the grounds for determining reference levels and values, and

5. the recording and reporting of data concerning procedures involving exposure to radiation so that the procedures and the radiation exposures resulting from them may be determined retrospectively and summaries of them may be compiled.

The Ministry of Social Affairs and Health may authorise STUK to issue detailed restrictions governing the use of radiation referred to at point 2 of paragraph 1 and to set the reference levels and reference values referred to at point 4.

Chapter 11 Non-ionizing radiation

Section 42 Scope of regulatory control

The regulatory control referred to in chapters 6 and 7 of this Act shall not apply to radiation appliances emitting non-ionizing radiation if the exposure they cause does not exceed the proportion of the maximum value stipulated by decree.

Section 43 Stipulating of maximum values for exposure to radiation

The maximum values for exposure to non-ionizing radiation shall be stipulated by the Ministry of Social Affairs and Health.

Section 44 Authority to issue Decrees

Detailed provisions on the regulatory control of non-ionizing radiation shall be issued by decree.

It may also be stipulated by decree that a radiation safety officer may be appointed to supervise the use of a radiation appliance emitting non-ionizing radiation if this is necessary to ensure safety in view of the properties of the radiation appliance and its operating conditions.

Separate provisions shall govern equipment used at work which emits non-ionizing radiation or ultrasound.

Chapter 12 Natural radiation

Section 45 Reports on radiation exposure

Anyone using naturally occurring earth, stone or other materials, or materials produced as a result of using these materials, in industrial or comparable operations shall investigate the radiation exposure caused by these practices in a manner acceptable to STUK if it is found, or if there is reason to suspect, that the operations constitute radiation practices. The same obligation shall apply to an employer if it is found, or if there is reason to suspect, that the radiation exposure originating from natural radiation and occurring in the employer's working facilities or other workplace causes or is liable to cause detriment to health.

If the party required to make such an investigation fails to do so, then STUK shall be empowered to issue an order to this effect.

Section 46 Limiting radiation exposure

When the investigation referred to in Section 45 has been made, STUK shall, where necessary, issue instructions on limiting the exposure to radiation.

Section 47 Organization description

If the work performed at a facility referred to in Section 45 constitutes radiation work as defined in Section 32, then the responsible party shall furnish an account of the arrangements that have been made to ensure safety. The applicable provisions of Section 18 governing the description of the radiation user's organization shall apply to this description, to the appointment of a radiation safety officer, and to the qualifications thereof.

Section 48 Radon in indoor air and radioactivity in household water (23.12.1998/1142)

The upper limits for the radon content of indoor air shall be stipulated by the Ministry of Social Affairs and Health.

Detailed provisions on the limitation and regulatory control of radiation exposure due to radioactive substances in household water shall be stipulated by an order of the Ministry of Social Affairs and Health. (23.12.1998/1142)

Section 49 Authority to issue decrees

Detailed provisions on the regulatory control of radiation exposure due to natural radiation shall be issued by decree.

Chapter 13 Radioactive waste

Section 50 Duty of care of the responsible party

The responsible party shall take the measures necessary to render harmless any radioactive waste arising from its operations.

When handling radioactive substances, the responsible party shall ensure that the release of radioactive substances into the environment is adequately restricted. If radioactive substances are released into the environment to such an extent that environmental decontamination measures are required in order to avert consequent health or environmental hazards, then the responsible party shall ensure that the said decontamination measures are taken.

When utilizing natural resources containing radioactive substances, the responsible party shall ensure that radioactive waste poses no hazard to health or to the environment, both during the operations and on their conclusion.

Section 51 Secondary duty of care

If the responsible party fails to discharge the duty of care referred to in Section 50, then the State shall take the measures necessary to render any radioactive waste harmless and to decontaminate the environment.

The State shall also take measures of the kind referred to in paragraph 1 hereof when the origin of the waste is unknown, or when no responsible party subject to a primary duty of care can be found.

Detailed regulations on the manner in which the State shall attend to the measures referred to in paragraph 1 hereof shall be issued by decree.

The responsible party and others who have been involved in producing or handling the radioactive substances or waste shall compensate the State for the expenses incurred in implementing the measures necessary to render the waste harmless and to decontaminate the environment. Recovery of the said expenses shall be governed by the provisions of Section 69. In the first place, however, the security referred to in Section 19, where such has been furnished, shall be used to compensate for the said expenses.

Section 52 Transferor's duty to obtain information

When transferring radioactive waste the possession of which requires a safety licence, the transferor shall ensure that the transferee has a safety licence to possess the transferred waste.

Section 52 a (22.12.1994/1334) Import, export and transit

Radioactive waste or material containing radioactive waste may be imported to, exported from or carried in transit through the territory of Finland only with the prior authorization of STUK for each consignment.

Radioactive waste shall not be exported to a country whose technical, legislative or administrative facilities are inadequate for the care of radioactive waste.

Disused radiation sources that were not manufactured in Finland may not be imported to Finland as radioactive waste. (22.12.2005/1179)

Shipments of radioactive waste shall be arranged in the manner prescribed in Council Directive 2006/117/Euratom on the supervision and control of shipments of radioactive waste and spent fuel, hereinafter referred to as the Shipments Directive. (21.11.2008/718)

In addition to the provisions of Article 17 of the Shipments Directive, the Radiation and Nuclear Safety Authority shall publish in its collected regulations a version of the standard document referred to in the said Article. (21.11.2008/718)

Chapter 14 Rights of the regulatory authority

Section 53 Right to conduct inspections and obtain information

For the purpose of regulatory control required by this Act and by the provisions and regulations issued pursuant thereto, STUK shall be authorized:

1. To inspect and monitor practices referred to in this Act giving rise to radiation exposure which is hazardous to health, and to have access to places in which such operations are performed,

2. To conduct the tests and measurements necessary for regulatory purposes, to take or obtain the necessary samples, and to install the devices needed for regulatory purposes at the said places or in the vicinity thereof,

3. To obtain the notifications, data and documents needed for regulatory purposes, and

4. To require a licensee to maintain records necessary for regulatory purposes concerning the radiation sources in its possession and the acquisition and transfer thereof, and to submit to STUK the notifications pertaining thereto.

Section 54 Orders

When necessary, STUK and the persons performing the inspection referred to at point 1 of Section 53 shall be authorized to issue orders pertaining to ensuring the safety of radiation operations and to rendering harmless any radioactive waste. When orders are issued, a time limit shall be imposed for compliance. If an order has been issued by a person performing an inspection, then the matter shall be submitted to STUK for decision if the responsible party so demands in writing.

Section 55 Discontinuation or restriction of operations

If a practice causes an obvious detriment to health or the danger thereof, then STUK may order that it be discontinued or restricted so as to comply with the provisions of this Act.

If the matter brooks no delay, then a person performing an inspection shall be authorized to order that the practice be discontinued or restricted, and the responsible party shall comply with this order immediately. The person performing the inspection shall then submit the matter without delay to STUK for decision.

An order to discontinue or restrict a practice shall remain valid until the responsible party demonstrates, or it is otherwise verified, that the practice may continue according to the provisions of this Act or of requirements prescribed pursuant thereto.

Section 56 (22.12.1994/1334) Prohibition of sale and transfer

If a product referred to in Section 21 fails to meet the safety requirements pertaining thereto, then the regulatory authority shall be authorized to prohibit the sale or other transfer thereof.

Section 57 Obtaining information from other authorities

Notwithstanding provisions on the confidentiality of certain matters and documents, the regulatory authority supervising compliance with the provisions and regulations of this Act or with those issued pursuant thereto shall be entitled to obtain from another public authority any information and documents necessary for its regulatory control.

Section 58 Official assistance

The police and customs authorities shall furnish the regulatory authority, as necessary, with official assistance in supervising compliance with the provisions of this Act and with the regulations issued pursuant thereto. Provisions on the special duties of the customs authorities in supervising compliance with this Act shall be issued by decree where necessary.

Chapter 15 Enforcement and consequences

Section 59 Threat of fine and ordering neglected action to be taken at the defaulter's expense

Any party neglecting the obligations imposed thereupon by the provisions and regulations of this Act and those issued pursuant thereto may be ordered by STUK to comply with the said obligations under threat of fine, or by threatening that the neglected measure be performed at the defaulter's expense, or that the operations will be discontinued or use of the radiation source prohibited.

A threat of fine shall be ordered by STUK.

The costs of action ordered to be performed at a defaulter's expense shall be paid in advance from State funds and recovered from the defaulter in the order prescribed in the Distraint of Taxes and Debts Act (367/1961).

Section 60 (21.4.1995/594) Reference provisions concerning penalties (24.5.2002/418)

Penalties for the use of radiation in a manner liable to endanger life or health are prescribed in sections 4, 5, 7 and 8 of chapter 34 of the Penal Code.

Penalties for environmental damage occasioned contrary to this Act and to provisions and regulations issued pursuant thereto are prescribed in sections 1 - 4 of chapter 48 of the Penal Code.

Penalty for careless handling of radioactive material or a radiation device is prescribed in chapter 44 Section 12 of the Penal Code.

Section 61 (24.5.2002/418) Radiation offences

Any responsible party who deliberately or through gross negligence:

1. fails to apply for a safety licence as stipulated in this Act,

2. infringes or fails to comply with the conditions of the safety licence or with orders issued by an authority pursuant to this Act for the purpose of ensuring safety or to notifying information needed for regulatory control purposes,

3. neglects to provide the information prescribed in Section 15, the transferor’s obligations prescribed in Section 28, the duty of care prescribed in Section 29, the transferor’s duty to procure information prescribed in Section 52, or the duty to seek the authorisation prescribed in Section 31 e or in Section 52 a, (22.12.2005/1179)

4. neglects the duty of accounting and notification prescribed in Section 14 b, or the provisions of a Decree of the Council of State on notification of the regulatory authority regarding receipt, transfer or other accountable actions pertaining to radiation sources containing radioactive substances, (22.12.2005/1179)

5. manufactures a high-activity sealed source without identification thereof in accordance with the provisions of Section 31 d, or imports an unidentified high-activity sealed source contrary to the prohibition prescribed in paragraph 3 of Section 31 d, or (22.12.2005/1179)

6. fails to comply with a prohibition on sale or transfer issued pursuant to Section 56. shall be sentenced to a fine for infringing the provisions of the Radiation Act unless the offence is punishable under Section 60, or unless a more severe penalty is prescribed elsewhere in the law.

Section 62 (21.5.1999/647)

Repealed by act 21.5.1999/647.

Section 63 (26.10.2001/893)

Repealed by act 26.10.2001/893.

Section 64 (13.5.2011/489) Preferring of charges

The public prosecutor may prefer no charges for an offence referred to in this Act before obtaining a statement on the matter from the Radiation and Nuclear Safety Authority.

Chapter 16 Appeals

Section 65 Appeals

Amendment to a decision issued by the Radiation and Nuclear Safety Authority - STUK pursuant to this Act may be sought by appeal to an anministrative court as prescribed in the Act on Appeals in Administrative Matters (no 586 of 1996). (2.9.2005/727)

No separate appeal shall lie, however, against a decision issued by STUK concerning imposition of a threat of fine pursuant to Section 59.

Section 66 Implementation

A decision issued pursuant to sections 54 and 55 of this Act may stipulate that the decision shall be observed notwithstanding an appeal pending, unless otherwise ordered by the appellate authority.

If the stipulation referred to in paragraph 1 has been issued, then the appellate authority shall process the appeal as an urgent matter.

Chapter 17 Miscellaneous provisions

Section 67 Abnormal radiation conditions

The principles prescribed in Section 2 shall, to the extent possible, be taken into account in seeking to limit exposure to radiation, even when the amount of radioactive substance released into a working area or environment is so great as to necessitate special measures to ensure radiation safety (abnormal radiation conditions).

The Ministry of the Interior shall issue general regulations and instructions on planning and coordination of measures in the event of abnormal radiation conditions.

Section 68 Disclosure of confidential information (21.5.1999/647)

Notwithstanding the obligation of confidentiality prescribed in the Act on the Openness of Government Activities (621/1999), information obtained in supervising compliance with this Act, or obtained by a member or secretary of the Advisory Board for Radiation Safety in the performance of their duties, and which concerns the financial status of a private individual or corporation, or a business or professional secret, or the personal circumstances of a private individual, may be divulged pursuant to Section 57, both to a prosecuting authority or to the police for the purpose of investigating an offence.

Section 69 Fees and charges

Fees may be charged, according to the decision of the competent ministry, for decisions on safety licences and for other decisions issued by authorities pursuant to this Act, for performances involved in the regulatory control referred to in this Act and for measures required in preparing such decisions and performances. The said fees and charges shall be governed by provisions of the State Fees and Charges Act (150/1992). (22.12.1994/1334)

A decision may be taken to charge a responsible party in the form of annual payments for all or part of the costs incurred in regulatory control of radiation practices. (22.12.1994/1334)

The fees, charges and compensation prescribed in this Act shall be subject to distraint without court judgement or decision, in the order prescribed for the recovery of taxes and debts by distraint.

Section 70 More detailed provisions and instructions of STUK

More detailed provisions on the implementation of this Act and on the division of duties and cooperation between authorities shall be issued by decree.

STUK shall issue general instructions on achieving the standard of safety defined in this Act.

Section 71 (22.12.2005/1179)

Repealed by act 22.12.2005/1179.

Section 72 (23.5.1997/490)

Repealed by act 23.5.1997/490).

Chapter 18 Entry into force and transitional provisions

Section 73 Entry into force

This Act shall enter into force on 1 January 1992.

This Act shall repeal the Radiation Protection Act of 26 April 1957 (174/1957) and subsequent amendments made thereto.

Measures necessary for the implementation of this Act may be taken before the entry into force thereof.

Section 74 Transitional provisions

A safety licence granted under the Radiation Protection Act shall remain valid until further notice. Within one year of the entry into force of this Act, however, the licensee shall notify STUK of its continuation of the radiation practice concerned. If no notification is made within the prescribed period, then the licence shall be deemed to have expired.

If the practice referred to in a safety licence granted pursuant to the Radiation Protection Act fails to meet the requirements prescribed in this Act, then STUK shall, no later than one year after receiving the notification referred to in paragraph 1, order the licensee to apply for a new safety licence. If the licensee fails to comply with the said order within four months, then the safety licence shall be deemed to have expired.

In all cases other than those referred to in paragraphs 1 and 2, an application for a safety licence shall be filed within one year following the entry into force of this Act for any practice which requires a safety licence according to this Act and has begun before the entry into force of this Act.

Section 75

Any person who has been approved as a radiation safety officer referred to in Section 5 of the Radiation Protection Decree (328/1957) shall be entitled to continue in the said duties on the entry into force of this Act.

Section 76

Repealed by act 22.12.1994/1334.

Section 77

A party responsible for mining operations referred to in the Mining Act, and for excavation projects lasting longer than three months and performed underground or in confined spaces, shall notify STUK in writing of such operations within three months of the entry into force of this Act.

Section 78

The processing of any matter referred to in the Radiation Protection Act and pending at STUK or at some other authority on the entry into force of this Act shall be governed by the provisions of this Act.

Amendments:

27.11.1992/1102:

22.12.1994/1334:

21.4.1995/594:

23.5.1997/490:

23.12.1998/1142:

21.5.1999/647:

26.10.2001/893:

24.5.2002/418:

23.8.2002/744:

2.9.2005/727:

22.12.2005/1179:

21.11.2008/718:

13.5.2011/489:

10.6.2011/624: