Licensing and notification for research involving ionising radiation

Fill in and submit the form Application for licence to conduct activities involving ionising radiation. The form must be signed by an authorised signatory.

General description of the activity

Describe the activity and its purpose for using the specified radiation sources.

For HASS, also include:

a) The physical location of the source within the facility.

b) Whether contract workers may perform any tasks.

For open sources, also include:

a) Nuclide-specific details of maximum activity per use occasion.

b) Nuclide-specific details of maximum activity intended for storage.

Organisation and management system

3. Describe which tasks may result in radiation doses to workers or others during normal operation. Also describe tasks or events that may pose an increased risk of radiation exposure. (Chapter 2, Section 1 of SSMFS 2018:1)

4. Attach an organisational chart. (Chapter 3, Section 1 of SSMFS 2018:1)

5. Describe which person or function is responsible for radiation protection tasks in the following areas:

• Organisation and management system
• Competence
• Protection of workers and the public
• Premises and radiation protection equipment
• Radiation sources

If responsibilities are divided among multiple people or functions, describe the division of responsibilities and how they cooperate.

For open sources, also include the area of radioactive waste. (Chapter 3, Section 2 of SSMFS 2018:1)

Competence

6. Describe the radiation protection expert function, including:

a) Documentation proving that the organisation has an approved expert function, or an application for approval of a new or modified function, according to instructions for applying for approval of radiation protection experts.

b) Copies of valid contracts or similar if the expert function involves external persons.

c) Documentation on the expert function’s authority and how it reports to senior management. (Chapter 3, Section 12 of SSMFS 2018:1)

7. Describe how it is ensured that workers have sufficient competence before starting work with radiation sources. (Chapter 3, Section 10 and Chapter 4, Section 13 of SSMFS 2018:1)

Protection of workers and the public

8. Describe how it is ensured that instructions for radiation protection measures are available at each workplace where radiation sources are used. (Chapter 4, Section 2 of SSMFS 2018:1)

9. Describe how workers are classified by exposure category. (Chapter 4, Section 15 of SSMFS 2018:1)

Premises and radiation protection equipment

10. Attach a floor plan of the relevant premises showing the location of radiation sources.

For premises or workplaces where sources or waste are handled or stored, include:

a) Shielding in walls, floors, ceilings, doors and windows.

b) Classification of rooms. (Chapter 4, Sections 3–4 of SSMFS 2018:1)

c) Use of adjacent rooms. d) Internal transport routes for radiation sources. (Chapter 4, Section 1 of SSMFS 2018:1)

Radiation sources

11. Fill in the form New registration of radiation source equipment for sources not previously registered with the Swedish Radiation Safety Authority.

For HASS, include the following information:

a) The source’s:

• Nuclide
• Activity
• Type designation
• Identification number (can be added later)
• Physical and chemical properties
• Photos or drawings
• Manufacturing date (can be added later)
• Manufacturer or supplier and their contact details
• Capsule designation
• ISO or ANSI classification, or other equivalent classification
• Certificate number for special form radioactive source

b) Any device or container that the source is part of:

• Type of device or container (e.g. level gauge, radiography equipment)
• Make and type designation
• Whether the device is stationary or portable
• Technical documentation such as product sheets, photos or drawings
• Identification number (can be added later)

c) Consignor.

d) Information on how the source and the device or container are labelled. (Chapter 6, Sections 1 and 11 of SSMFS 2018:1)

12. Describe how the radiation sources will be managed when the activity ends.

For HASS, also attach:

a) Copy of current agreement for disposal of the source

b) Financial guarantee showing that sufficient funds have been set aside to ensure proper disposal of the source. This does not apply to government agencies, municipalities, regions or municipal federations. You may use the Financial Guarantee form. (Chapter 6, Section 18 of SFS 2018:396 and Chapter 5, Section 14 of SSMFS 2018:1)

The time it takes to process an application varies depending on factors such as complexity, type of licence and the authority’s workload at the time in question. We will begin dealing with the matter when we receive a completed application. If the application is incomplete and supplementation is required, the processing time will be extended accordingly. If the requested information is not forthcoming, we may need to reach a decision based on the information we have to hand, or we may dismiss the application entirely.

A decision regarding a permit, or licence, under the Radiation Protection Act (2018:396) may be appealed to the Administrative Court in Stockholm. The decision includes instructions on how to lodge an appeal.

According to the Ordinance (2008:463) on certain fees to the Swedish Radiation Safety Authority, the application fees for activities requiring a licence are as follows:

• SEK 2,300 for activities involving open radioactive sources with an activity of up to 100 megabecquerels.
• SEK 6,900 for activities involving open radioactive sources with an activity exceeding 100 megabecquerels but not exceeding 10 gigabecquerels.
• SEK 38,900 for activities involving open radioactive sources with an activity exceeding 10 gigabecquerels.
• SEK 6,900 per particle accelerator with an energy output exceeding 1 megaelectronvolt but not exceeding 100 megaelectronvolts.
• SEK 26,100 per particle accelerator with an energy output exceeding 100 megaelectronvolts.
• SEK 2,300 per sealed source that is not a high activity sealed source (HASS).
• SEK 11,600 per device containing one or more high activity sealed sources (HASS).
• SEK 3,500 per technical device with an energy output of up to 1 megaelectronvolt.

The following laws, ordinances and regulations govern activities requiring a licence:

Pursuant to Section 1 of Chapter 6 of the Swedish Radiation Protection Act (2018:396), it is prohibited to conduct unlicenced activities involving ionising radiation. Pursuant to point 1 in Section 2 of Chapter 9 of the same act, anyone intentionally or negligently breaching this prohibition may be sentenced to a fine or imprisonment for up to two years.

If you cease activities involving ionising radiation, you need to be able to demonstrate that all registered radioactive substances and x-ray equipment have been dealt with in accordance with Swedish Radiation Safety Authority regulations and report to us accordingly. We can then write-off your activity and annual fee. You are also required to decontaminate premises in which you have used radioactive substances as radioactive sources, so that the premises can be given clearance.

Deregistering radioactive substances

Contact the company from which you purchased the radioactive substance for assistance with safe handling and report the changes to us by completing and submitting the form for deregistering equipment.

Deregistering x-ray tubes

Deposit the x-ray equipment with a radioactive waste company and report the changes to us by completing and submitting the form for deregistering equipment. You also need to send us an original certificate in which you or the waste firm certifies that the x-ray tube is been rendered unusable.

Clearance of premises

Clearance is required for premises no longer used for work involving radioactive substances in the form of open radioactive sources. Obtaining clearance involves:

• the decontamination of all surfaces that may have been contaminated by the radioactive source;
• dealing with radioactively contaminated equipment and other inventory in a safe manner; and
• reporting the implementation of certain decontamination measures and the results of control measurements to the Swedish Radiation Safety Authority, which will then decide whether to grant clearance.

Clearance is regulated in Swedish Radiation Safety Authority Regulations (SSMFS 2018:3) concerning Exceptions from the Radiation Protection Act and the Clearance of Materials, Buildings and Areas.

1. Log in to our e-service using your Freja eID or BankID.
2. Select the type of activity you wish to register.
3. Provide the following details:
1. Invoicing address
2. Invoice reference
3. Preferred means of invoicing
4. Contact details for someone who can answer any questions
5. The make, model and serial number of the equipment (the serial number can be registered at a later date)
6. Any supplier information
7. Address where the practice is located
4. You also need to supply details of the equipment to which your application relates.

When you have signed your notification, a confirmation will be sent to your email address. This means that your notification has been approved. Save this confirmation as it is only generated once when you register.

Your notification is valid for five years. You can renew it no earlier than six months before it expires. The renewal must be submitted via our e-service.

You have automatic authorisation to log in to the e-service if you are an authorised signatory, CEO or director of the company. If the signatures of multiple directors are required, you will need power of attorney to log in. Power of attorney is also required if someone other than an authorised signatory or CEO is representing the organisation. Power of attorney is also required for sole traders, limited partnerships, economic associations, publicly owned companies and public authorities.

You can apply for power of attorney in two ways:

1. The authorised signatory or CEO can log in and delegate authority to represent the organisation. The representative must then log in and approve the information in the e-service.
2. The representative can log in directly to the e-service and enter and send their details.

In both cases, documentation of delegation must be attached and signed and approved by the authorised signatory or CEO. This must state the name and job title of the delegator and the name and personal identity number of the delegatee.

The Swedish Radiation Safety Authority will check the information and a case officer from the authority must approve power of attorney. A confirmation document will be emailed to the representative once power of attorney has been approved.

According to the Ordinance (2008:463) on certain fees to the Swedish Radiation Safety Authority, the fee for notifiable activities is SEK 1,850.

The obligation to notify is regulated by the following acts, ordinances and regulations:

If you no longer conduct an operation registered with the Swedish Radiation Safety Authority, you can deregister by emailing us at Tillstandsprovning-stralskydd@ssm.se. Please state the registration number.