Trade, import and export of radioactive materials and consumer products
The Radiation and Nuclear Safety Authority supervises the trade in radioactive substances as well as their import to Finland and export from Finland. Import and export is also supervised by Customs. Fire alarms and some other consumer products may also use small amounts of radioactive material. The Radiation and Nuclear Safety Authority supervises the trade in such consumer goods and the radiation safety of the products. The technical compliance of fire alarms is also supervised by the Finnish Safety and Chemicals Agency Tukes.
Trade, import and export of radioactive materials
The Radiation and Nuclear Safety Authority (STUK) supervises the trade in radioactive substances as well as their import to Finland and export from Finland. Import and export is also supervised by Customs. The customs declaration must indicate the nature and quantity of the radioactive substances as well as the number of the licence entitling them to be imported or exported.
Import of radioactive material refers to the importation from countries outside the European Union and export refers to the exportation to countries outside the European Union. Such imports or exports, as well as trade in radioactive substances, must have a safety licence granted by STUK.
Shipment and reception of radioactive substances between the Member States of the European Union constitutes a transfer of radioactive substances. These transfers do not require a separate licence granted by STUK. However, Council Regulation 1493/93/Euratom applies to transfers and imposes a duties to obtain information and reporting obligations on the consignor. The Council Regulation is in force in all EU Member States.
In connection with this Regulation, STUK must confirm a document by which the receiver of sealed sources in Finland demonstrates to the consignor that a safety licence for the use of a radiation source exists. STUK also receives notifications from consignors of radiation sources arriving from other EU countries concerning radioactive substances delivered to Finland.
Radioactive substances and restrictions on use in consumer products
Fire alarms and some other consumer products may also use small amounts of radioactive material. STUK supervises the trade in such consumer goods and the radiation safety of the products. The technical compliance of fire alarms is also supervised by the Finnish Safety and Chemicals Agency Tukes.
The market surveillance carried out by STUK is targeted at products which are normally not inspected at their places of use. Such products on the market include, in particular, consumer products containing radioactive substances. In the supervision of consumer goods, STUK co-operates, where necessary, with the Finnish Competition and Consumer Authority (FCCA) and Tukes.
The market surveillance authority for fire alarms is Tukes. It ensures that fire alarms comply with the requirements set out in the rescue legislation and the regulations issued on the basis thereof. The import and sale of fire alarms containing radioactive substances also require a safety licence granted by STUK, and the placing on the market of new models of fire alarms requires STUK's approval.
The use of radioactive substances in foodstuffs, cosmetic products, toys and similar consumer goods is prohibited under section 68 of the Radiation Act. The import and export of consumer goods containing radioactive substances is also prohibited.
For justified reasons, STUK may approve the use of radioactive substances as radiation sources in consumer products. Approved applications include fire detectors containing americium (Am-241) and special lamps (for example, xenon lamps used in cars) with small amounts of thorium (Th-232 or Th-228) or krypton (Kr-85). The trade and importation of fire alarms or special lamps containing radioactive substances is subject to a safety licence.
The trade, import and export of radiation sources are subject to many requirements. The requirements are laid down in the Radiation Act (859/2018), the Government Decree on Ionizing Radiation (1034/2018) and the Decree of the Ministry of Social Affairs and Health on Ionizing Radiation (1044/2018), as well as in STUK regulations.
Definitions
‘Radiation source’ means a radiation appliance and a radioactive substance used because of its radioactivity.
‘Radiation appliance’ means a device which produces radiation electrically or in which a radioactive substance is used due to its radioactivity.
Import, export and transfer
Radioactive substances
Council Regulation (Euratom) No. 1493/93 provides for the shipment of radioactive substances between EU member states. The regulation applies to radioactive substances with activity exceeding the exemption value.
The consignor of a sealed source must obtain a prior declaration that the recipient has the appropriate safety licence for the possession of the source. The prior declaration is made using this form.
When a radioactive substance is transferred to another EU country, the consignor must report these transfers (shipments) to the authority of the country of destination on a quarterly basis. The notification must be submitted within 21 days of the end of the quarter. Both sealed and unsealed sources must be reported. The information to be provided in the notification is defined in Council Regulation 1493/93/Euratom.
Radiation sources
A licence is required for the import of any radiation source (including X-ray appliances and accelerators) from outside the EU. This also applies when equipment sent to a non-EU country for servicing is returned to Finland or to the import of your own equipment back from a business trip outside the EU. No licence is required for the import of an X-ray tube or other individual component.
Leasing
Commercial leasing of equipment to other licensees may be included in commercial activities. The lessee of the equipment must be authorised to use it.
Demonstration use
Commercial activities may include demonstrations in which the X-ray equipment is not started up, empty containers for sealed source devices are displayed, and other such sales and marketing activities. However, the undertaking must apply for a licence that covers the
use of the equipment if the undertaking demonstrates sealed source equipment at a trade fair or at customers' premises, or starts up the demonstrated X-ray equipment, for example.
The demonstrated devices and their serial numbers are added to the licence. If the device used in demonstrations changes frequently (for example, if the device is imported from abroad for demonstration purposes only or different devices in the sales warehouse are used for demonstration), each device model used may be attached to the licence without a unique serial number.
Duty to obtain information
Radiation sources may not be handed over to an undertaking that does not have a safety licence for their use or possession. If the undertaking already has a licence for the use of corresponding radiation sources, the undertaking has to notify STUK of the new radiation sources within two weeks.
The mere possession of radiation sources – including industrial and research X-ray equipment – is also subject to a licence. Equipment may not be even handed over to the operator's warehouse to wait for installation unless the operator has been granted a safety licence.
Obligation to provide information
When handing over a radiation source, the manufacturer or importer must provide the recipient with detailed information on the structure of the source and its properties having an impact on safety.
In addition, a certificate of conformity must be provided for the sealed source, together with a written commitment by the manufacturer to receive the sealed source at the end of use, and the results of the most recent leakage test.
Annual notification
STUK must be notified annually of each reception, hand-over and possession of radiation sources. The notifications have to be submitted by the end of January of the following year.
Appendix 10 to Regulation STUK S/5/2019 sets out the information required in the notification.
Among the information is the serial number of each sealed source received and handed over. This piece of information is important for the monitoring of the life cycle of each sealed source, starting from its import to Finland all the way to final disposal or export.
Security deposits
The security deposit provided for in section 54 of the Radiation Act may also apply to undertakings trading in radioactive substances if:
- the undertaking engages in trade in high-activity sealed sources
- the sum of the nuclide-specific activity of the radioactive substance held at any one time is greater than that of the corresponding high-activity sealed source.
No security deposit is needed when the half-life is less than 150 days (for example iridium-192 or selenium-75).
Transport
All transport of radioactive substances must comply with the Act on the Transport of Dangerous Goods (719/1994). Transport of high-activity sealed sources also requires a safety licence for the practice.
Safety assessment
The safety assessment must, subject to certain exceptions, be prepared with the assistance of a Radiation Safety Expert. Section 17 of the Government Decree contains provisions on the use of a Radiation Safety Expert, and section 18 contains provisions on the areas where a Radiation Safety Expert must be used.
Practices exempt from a safety licence
Pursuant to section 27 of the Radiation Act, a safety licence is not required for the following practices:
- the use, manufacture, trade, installation, possession, safekeeping, import, shipment or storage of an appliance that produces ionizing radiation electrically, provided that the appliance operates with a maximum voltage of 30 kilovolts and does not cause, within a ten centimetre distance of the appliance’s accessible surfaces, a greater dose rate than one microsieverts per hour
- the use of fire alarms and smoke detectors containing americium-241 (Am-241) for the purpose for which they have been designed, or their resale and use, or the possession, retention, storage, installation, maintenance or repair related to their use and resale (new fire alarms may nevertheless contain a maximum of 40 kilobecqurels (kBq) of Am-241)
- the use of a sealed source containing a maximum of 40 kBq of the isotope Am-241, strontium-90 or caesium-137 with radiation safety properties meant for educational use as a teaching aid in schools, vocational schools and comparable institutions, provided that the educational institution has appointed a person in charge of radiation safety
- the use of lamps and igniters containing a maximum equal to the exemption value of a radioactive substance for the purpose for which they have been designed, and their resale or the possession, safekeeping, storage, installation, maintenance and repair related to their use and resale.
This means that, for example, it is not necessary to apply for a model-specific exemption from a safety licence for the use of the aforementioned smoke alarms or teaching aids. Provisions concerning the exemption of other radiation sources from a safety licence are laid down in section 50 of the Radiation Act and in section 28 of the Government Decree.