New regulations introduce obligatory notification

Veterinarians and dentists with specific kinds of X-ray equipment, workplaces with high levels of radon, and activities involving naturally occurring radioactive material are some of the operations involving ionising radiation that no longer need to be licensed. Instead, the specific activity must be notified to the Swedish Radiation Safety Authority under its new regulations in effect as of 1 June 2018.

On this date, the Radiation Protection Act with the appurtenant ordinance were replaced by new enactments. The new regulatory framework gives the Authority the possibility to introduce obligatory notification that applies to certain activities involving ionising radiation. These notifiable activities are implemented as of the new regulations issued by the Swedish Radiation Safety Authority, which came into force at the same time as the new act and ordinance.

"This has presupposed a great deal of assessment work in order to delineate which activities can be dealt with by means of obligatory notification. The activities and practices defined by the new regulations as encompassed by an obligation to provide notification to the regulator will be subject to a level of requirements that better matches the level of risk. In this way, the Authority has introduced a more straightforward procedure," says Ulf Yngvesson, Chief Legal Officer at the Swedish Radiation Safety Authority.

As of 1 June 2018, the below comprise notifiable activities:

  • dental X-ray diagnostics using intraoral image receptors
  • X-ray diagnostics of small animals in veterinary medicine
  • X-ray in freight management and material analysis (e.g. cabinet X-ray, XRF and XRD)
  • sealed radioactive sources not classified as high activity sealed sources (HASS)
  • unsealed sources of low radioactivity
  • workplaces with radon concentrations above 200 Bq/m3
  • microwave drying
  • sunbeds for medical purposes
  • operations involving naturally occurring radioactive material (NORM)
  • commercial trade in radioactive sources, apart from sources classified as HASS

In the case of operations that did not require individual permission earlier, though which now comprise notifiable activities, notification thereof is to be made to the Swedish Radiation Safety Authority starting on 29 January 2019.

Apart from this requirement to notify the Swedish Radiation Safety Authority of one's activity, the rewritten Radiation Protection Act also regulates the areas of nuclear and radiological emergencies and environments with ionising radiation. The latter relates to locations where ionising radiation is present without human involvement. One example is radon.

"This has also resulted in new regulations targeting radon in workplaces. This means that occupational settings where radon levels exceed 200 Bq/m3 are now subject to obligatory notification," says Mr Yngvesson.

For more information, please contact: Ulf Yngvesson, Chief Legal Officer, Swedish Radiation Safety Authority (SSM), on Tel. +46 8 799 43 41, or SSM's duty press officer on Tel. +46 8 799 40 20.

Background

Since 2013, regulations belonging to the Swedish Radiation Safety Authority Regulatory Code, SSMFS, have been subject to review and revision. Revisions have been made owing to new EU Directives and changes due to external factors, as well as an international peer review of Sweden's regulatory system applying to the relevant fields.

On 1 June 2018, the existing Radiation Protection Act and Radiation Protection Ordinance were replaced by respective new enactments. At the same time, the Authority's new regulations entered into force. The radiation safety directive, i.e. Council Directive 2013/59/Euratom, is hereby implemented in Sweden through the new Act, Ordinance, and the above-mentioned new regulations.

The change to the regulatory structure is most clearly manifested in the form of a fundamental regulatory code, which contains basic provisions applying to licensed activities, in addition to a main regulation with basic provisions applying to notifiable activities (i.e. obligatory notification).