A safety licence is required for the use of radiation. Use of radiation includes all practices concerning radiation sources, such as trade in radiation sources and the manufacture, possession, servicing, repairs, import and export of radiation sources. Radiation sources include X-ray equipment, radioactive substances or devices that contain them.
What kind of practices do not require a safety licence?
Section 17 of the Radiation Act sets forth the safety licence-exempt practices. The most significant of these are:
- the use of non-ionizing radiation
- the use of a radiation appliance used as a consumer product (such as smoke alarms)
- the use of radioactive substances when their activity is below the exemption value
- transport of radioactive substances.
STUK’s Guide ST 1.5 provides more information on the exemption from the safety licence and the exemption values for radioactive substances, for example.
How is the safety licence applied for?
A licence can be applied for with forms available on the STUK website. There are separate forms for the use of radiation in health care and for other purposes (industry, research, trade, product inspections and safety checks, measurements and other services).
The following can be provided with the forms:
- basic information of the licence applicant (company or organization) and the radiation safety officer
- detailed information about the operations
- organization description (in health care and veterinary medicine)
- details of the radiation sources in use.
In addition to the forms, the application must include a copy of the radiation safety officer’s qualification certificate and, if the applicant is a company, a copy of the trade register extract. For the radiation premises of use in health care, the application must include the floor plans that indicate the structural shielding and the intended uses of the surrounding premises.
The role and duties of radiation safety officers are described in more detail in STUK’s Guide ST 1.4.
The licence application must demonstrate that the handling of radiation sources, the radiation sources and safety equipment, premises of use and radiation shielding, security arrangements, radiation user’s organization and safety instructions all follow the regulations and the ST Guides.
In addition to the forms, separate enclosures can be used for submitting additional information. Such information may include a description of the operations and the organization, structural drawings and brochures, operation and safety instructions for devices, test certificates for sealed sources and a report on the management and disposal of radioactive waste.
The applicant of a safety licence may be a business or sole trader, company, corporation, foundation or institution that conducts operations related to radiation sources.
The applications are submitted to: STUK – Radiation and Nuclear Safety Authority, P.O. Box 14, 00881 Helsinki.
What is the validity period of the safety licence?
Usually, a safety licence is valid until further notice. It can also be issued for a fixed period if the applicant knows that the use of radiation will be discontinued after a specific time.
In addition, keep in mind that the radiation safety officer and the members of the radiation user’s organization must receive supplementary training every five years, at the minimum. The requirements for supplementary training are presented in STUK’s Guides ST 1.7 and ST 1.8.
The validity of the safety licence ends and the licence is terminated when the licence holder declares that the use of radiation has been discontinued. If the licence holder was previously using radiation sources, it must also indicate where it has transferred them or how they have been rendered harmless.
Sealed sources can be transferred to the manufacturer, importer or Suomen Nukliditekniikka, which manages radioactive waste. When the use of unsealed sources ends, the licence holder must indicate how the waste has been aged harmless and how it has been ensured that the premises and equipment that were used are clean.
Radioactive substances can only be transferred to another responsible party if the recipient holds a safety licence that grants the right to use them.
What is the fee for processing the safety licence application?
A fee according to STUK’s regulatory service price list is charged for a safety licence decision. An operations and device-specific annual fee is charged for valid licences. No fee is charged for terminating a safety licence in whole or in part.
Which changes must be reported to STUK?
STUK shall be notified within two weeks of the time when:
- a radiation source is acquired
- a radiation source is decommissioned
- a new radiation safety officer is appointed
- any essential change takes place in the radiation user's organization
- the use of radiation is discontinued in whole or in part.
Other changes must also be reported to STUK. These include, among others, changes to the place of use and licence holder, including its name and contact information.
STUK cannot modify a safety licence on its own initiative. Therefore, the licence holder must always notify STUK of any changes in the operations. STUK should be notified of the changes in advance, if possible.
There is a form available on the website for updating the details of the licence holder and submitting a notice of changing the radiation safety officer or terminating the licence.