Notify if you work with or store concentrated infectious agents

If you intend to start working with or storing a concentrated infectious agent, you must notify the Swedish Work Environment Authority of the activity. If you then move your activity, you must give notification of the new address. If you do not notify of the activity or the move at the latest 30 days in advance, you must pay a sanction fee. You must also notify of other changes, which do not affect the protection requirements, within 30 days of the change.

Who should notify of their activity?

It is only if you intentionally work with or store concentrated infectious agents in risk classes 2, 3 or 4 that you must notify of the activity. Give notification no less than 30 days before you intend to start.

The provisions on notification are to be found in chapter 4, secton 8, first subparagraph, point 2, of the Work Environment Act and in section 29 of the Swedish Work Environment Authority’s regulations relating to infection risks (AFS 2018:4).

The Work Environment Act

Smittrisker (AFS 2018:4) Swedish

Who does not need to notify of their activity?

You do not have to notify of an activity if

  • you intentionally work with infectious agents in
    • primary culture or concentration directly from a sample from humans or animals, with no further cultivation,
    • work with genetically modified infectious agents where the activity has been notified or has authorisation under the regulations on the contained use of genetically modified microorganisms (AFS 2011:2),
  • infectious agents are present in the activity but you do not work intentionally with them, for example in
    • care for infected humans or animals,
    • biochemical analyses of samples from humans or animals,
    • disposal of waste containing infectious agents,
    • cleaning up of bird droppings,
    • working with sewage,
  • you work with infectious agents in risk class 1 which do cause illness in humans.

Notify of and update information on time

Notify the Swedish Working Environment Authority no later than 30 days before you

  • begin working with infectious agents for the first time,
  • move the activity to another address,
  • change the business identity code,
  • change the direction of the activity,
  • need to work at a different level of protection than you notified.

We need to have the information in order to be able to assess the activity from a protection point of view and to be able to carry out inspections. If you do not give notification at least 30 days in advance, you must pay a sanction fee.

Also notify of changes which do not affect the protection level

You must also notify of other changes which do not affect the protection level. It may be, for example, who your contact person is, who has management responsibility at your undertaking, or the fact that you identified new risks and therefore introduce new protective measures. Notify the Swedish Work Environment Authority within 30 days of the changes taking place.

Carry out a workplace investigation

You must carry out a workplace investigation. This means that you must examine the working conditions of your activity and assess the risks of working with the infectious agents. You must then decide which protective measures you need. You must submit the risk assessment as an attachment to the notification, for example as a Word file or pdf.

In the investigation you must pay particular attention to

  • which parts of work could entail a risk of infection,
  • how the infectious agents could cause infection,
  • what consequences this could have for workers and how serious those consequences are,
  • how long the workers are at risk of exposure to the infectious agents,
  • the risk class to which the infectious agent belongs according the list in Annex 1 to the regulation on risk of infections (AFS 2018:4). If your infectious agent is not included in the list, you must classify it according to the definitions set out in section 4 of that regulation.

Describe what safety measures are necessary and what level of protection you have to work on to handle the infectious agent safely. You are obliged to do so under sectoin 6 of the regulations.

How to notify of work with or the storage of concentrated infectious agents

Fill in information on

  • the organisation which intends to work with or store concentrated infectious agents: name, address and business identity code,
  • the facility’s street address and location at which you work with or store the infectious agent,
  • who the contact person is and who is responsible for the activity,
  • the direction of the activity,
  • which infectious agents you intend to handle,
  • which risks you have identified in the risk assessment,
  • what level of protection the activity will be performed at and which protective measures you must take in addition to the mandatory measures,
  • what other preventative measures you are planning.

Risk class 2

Work with or the storage of concentrated infectious agents - Risk class 2 (Swedish), pdf, opens in a new window

Risk class 3

Work with or the storage of concentrated infectious agents - Risk class 3  (Swedish), pdf, opens in a new window

Riskklass 4

Work with or the storage of concentrated infectious agents - Risk class 4 (Swedish), pdf, opens in a new window

Submit the form by email to registrator@av.se. Write ‘Notification of use of infectious agents under paragraph 29 of AFS 2018:4’ in the subject line. Attach the complete risk assessment. Send it as an attachment, for example as a Word file or pdf.

registrator@av.se

If the notification does not contain all the information, we will get in touch with the contact person and request supplementary information. We will first contact you by email. You will have 2 weeks to submit supplementary information.

Then the notification is complete, we will examine it and issue an acknowledgement that we have receive it.

Sanction fee

If you do not notify of the activity or move at the latest 30 days in advance, you must pay a sanction fee. The fee is SEK 5 000 - 50 000, depending on the number of employees in the company.

The rules on the sanction fee are to be found in chapter 8, paragraphs 5-10 of the Work Environment Act. The sanction fee is calculated on the basis of paragraph 29 of the Swedish Work Environment Authority’s regulation relating to infection risks (AFS 2018:4).

You may appeal against a fee

If you have been informed that you must pay a sanction fee, you may appeal against it. Information on how to appeal will be sent with the notice of the sanction fee.

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Last updated 2021-01-15