Licensing and notification

If a business plans to manufacture or import a consumer product that emits or may emit ionising radiation, it must have a licence from the Swedish Radiation Safety Authority.

The Swedish Radiation Safety Authority’s regulations (SSMFS 2018:1) define such a consumer product as a device or manufactured item in which one or more radionuclides have been deliberately incorporated or produced by activation, or that can generate ionising radiation, and which is sold to or made available to individuals for purposes outside of commercial use.

In Sweden, it is prohibited to add radioactive substances to food, animal feed, toys, jewellery, or cosmetics, or to cause radioactive substances to form in such products by irradiation. It is also prohibited to import or export such products to or from countries outside the EU or EEA, in accordance with Chapter 5, Sections 6–7 of the Radiation Protection Act (2018:396).

A licence application for manufacturing or importing such products must also include, according to Chapter 6, Section 22 of SSMFS 2018:1:

1. Intended use of the product
2. Technical specifications
3. Method of fixation of radioactive substances, where applicable
4. Ambient dose equivalent rates at relevant distances, including at 0.1 m from accessible surfaces
5. Expected radiation doses to users
6. Waste handling procedures
7. Any other relevant information to assess justification

Submit your application via: registrator@ssm.se.

Dental practices require a licence from the Swedish Radiation Safety Authority to use panoramic x-ray equipment and cone beam computed tomography (CBCT), whether their own equipment or equipment owned by another company. A licence is also required to use portable or handheld x-ray equipment and stationary intraoral scanners that do not meet the requirements of Swedish Radiation Safety Authority Regulations (SSMFS 2018:2) concerning Activities Subject to a Notification Obligation. To apply for a licence, the practice must be registered in IVO’s Healthcare Provider Register.

Anyone planning to use an intraoral scanner in their dental practice is required to notify us.

You may need a licence from the Swedish Radiation Safety Authority to export nuclear material or other nuclear products from Sweden. This also applies to the export of technical information and software related to such products. You may also require a licence for providing certain brokerage services from Sweden.

If you are planning to import or export radioactive waste or spent fuel to or from Sweden, you may need a licence for transboundary shipments from the Swedish Radiation Safety Authority.

Application forms can be obtained from the Swedish Radiation Safety Authority on request. Contact the authority’s registrar at registrator@ssm.se.

A licence is required from the Swedish Radiation Safety Authority to conduct industrial operations involving ionising radiation. For example, a licence is required for technical devices such as open radiography, sealed radiography and high-activity sealed radioactive sources (HASS).

Certain industrial operations involving radiation do not require a licence but we must be notified about them. This notification obligation applies to technical devices such as level sensors, density meters, thickness gauges, grammage meters, moisture meters, static eliminators/ionisers, x-ray fluorescence (XRF) spectrometers and cabinet x-ray systems.

In Sweden, the use of Class 3B or Class 4 lasers – in laser displays or nightclubs, for example – and powerful laser pointers in Classes 3R, 3B or 4 requires a permit from the Swedish Radiation Safety Authority. For some of these lasers, a permit is required to possess, acquire or import them into Sweden.

Healthcare providers require a licence from us to perform medical procedures involving a high-activity sealed radioactive source (HASS), open radioactive source or an x-ray examination or treatment that is not subject to a notification obligation pursuant to SSMFS 2018:2. A licence is also required for nuclear medicine diagnostics and treatment, and radiotherapy using x-rays, linear accelerators or sealed radioactive sources, as well as procedures involving cyclotrons. To apply for a licence, the practice must be registered in IVO’s Healthcare Provider Register.

Operations involving the use of microwave dryers are subject to a notification obligation pursuant to Section 8 of Chapter 1 of Swedish Radiation Safety Authority Regulations (SSMFS 2018:2) concerning Activities Subject to a Notification Obligation.

Register your operation by submitting a completed notification form to the Swedish Radiation Safety Authority.

If you handle naturally occurring radioactive material (NORM) as waste, by-product or raw material, including building materials, you may be subject to a notification obligation.

A licence is required to build, maintain or operate a nuclear facility. If you already hold a licence, you must apply for a new licence if you make alterations that are beyond the scope of your existing licence.

Nuclear facilities and changes that require a licence include new nuclear reactors, research reactors, increases in the thermal efficiency of a nuclear reactor, storage facilities for radioactive substances and storage facilities for radioactive waste.

The Swedish Radiation Safety Authority must be notified of any workplace with a radon level above the reference level of 200 Bq/m³, as well as any workplace in which employees risk an annual radon exposure exceeding 0.72 MBqh/m³.

A licence is required from the Swedish Radiation Safety Authority to conduct research involving ionising radiation. For example, a licence is required for research activities using high-activity sealed radioactive sources (HASS), accelerators and high-activity open radioactive sources.

Certain research activities involving radiation do not require a licence but we must be notified about them. For example, laboratory work, gas chromatography using an electron capture detector, working with sealed radioactive sources that are not highly active, trace element testing, fieldwork and working with low-activity open radioactive sources are subject to a notification obligation.

A licence from the Swedish Radiation Safety Authority is required to ship radioactive substances within Sweden or on a Swedish Marine vessel. Licensable shipments include spent and unused nuclear fuel, raw materials and semi-finished products associated with the manufacture of nuclear fuel, radioactive waste, and radioactive substances for use in healthcare, research and industry.

A licence from the Swedish Radiation Safety Authority is required for the installation and maintenance of technical equipment that can generate ionising radiation or that contains radioactive substances, as well as for the trade of high-activity sealed sources (HASS).

Certain types of trade involving radiation only require notification. This notification obligation applies to the trade of radioactive substances that are not HASS and technical equipment capable of generating ionising radiation.

Healthcare providers providing UV therapy are subject to a notification obligation pursuant to Section 9 of Chapter 1 of Swedish Radiation Safety Authority Regulations (SSMFS 2018:2) concerning Activities Subject to a Notification Obligation.

Register your operation by submitting a completed notification form to the Swedish Radiation Safety Authority.

Veterinary practices require a licence from the Swedish Radiation Safety Authority to conduct ambulatory activities, perform advanced x-ray diagnostics such as computed tomography (CT), radioscopy, and examinations using portable x-ray equipment, or to provide treatment involving radioactive substances and radiotherapy.

No licence is required to x-ray small animals, when the beam field is aimed straight downwards, or to take dental x-rays of small animals using intraoral scanners, but you must notify us that you intend to perform such procedures.

If your activity is not covered by any specific guidance above, or if it is exempted from licensing, pursuant to Section 5 a of Chapter 5 of the Swedish Radiation Protection Ordinance (2018:506) you are required to supply the following information to the authority when applying for a licence.

General information about the activity: An account of the activity including the following information:

• Description of the specialisation and scope of the activity.
• The radioactive sources used in the activity and the purpose of using these radioactive sources.
• The tasks and situations that, during normal use, may risk exposing people or the environment to radiation.
• A description and documentation of your organisation’s access to an expert radiation safety function.
• An account of how you ensure that staff have adequate competence before they begin working with radioactive sources.
• How your staff are categorised regarding radiation exposure.

Organisation and management system: An organisational plan and an account of which people or functions have duties related to radiation safety in the following areas:

• Organisation and management system
• Competence
• Protection of employees and the public
• Premises and radiation protection equipment
• Radioactive sources
• Radioactive waste

Your premises: A description of the design and areas of use of premises and adjacent areas. Show the placement of radioactive sources and describe how the organisation ensures that the exposure of employees and members of the public is limited, as well as how ionising radiation can be measured.

Decommissioning: An account of how radiation sources will be dealt with and handled when the activity ceases.

Apply for a licence at registrator@ssm.se.

Activities involving ionising radiation that have been exempted from licensing requirements through one of the following regulations do not require a licence: