Notify if you use genetically modified micro-organisms, GMMs

If you use genetically modified micro-organisms, GMMs, in your activities, you must notify the Swedish Work Environment Authority.

The Swedish Work Environment Authority needs to be aware of all use of GMMs in Sweden, where it is carried out and by whom. We need to know, for instance, that your facility is appropriately designed and equipped. The reason for this is the so-called ‘precautionary principle’ which applies throughout the EU. This means that more protective measures should be taken rather than too few.

Notify or apply for a permit?

Before you commence a GMM activity, you must notify it, or apply for a permit for it, depending on the category to which the activity belongs. There are three categories:

Notification

F activity

Containment level 1

L activity

Containment level 2

Permit

R activity

Containment level 3-4

In which cases should you notify or apply for a permit?

Submit a notification or an application for a permit for a new GMM activity if

you wish to start a GMM activity which you have not carried out previously
you wish to add a new GMM use to an existing activity
you need to increase the containment level for one or more GMM uses
you change the nature of your activity - you may, for example, have conducted laboratory activity involving a GMM and wish to use the same GMM to infect animals or plants, or culture them in a large-scale activity
you move your activity to a new facility
a different operator with a different business identity code takes over your GMM activity

For a new use in an existing F activity you merely have to submit an update. Forms for this are available on our website. You submit them in the same way as your notifications or permit applications.

Carry out a workplace investigation

You must carry out an investigation to assess which protective measures are necessary. Summarise the investigation in writing and set out which protective measures are necessary to enable you to use GMMs safely. You are required to do so under Section 3 of our regulation on contained use of genetically modified micro-organisms (AFS 2011:2).

The Swedish Work Environment Authority's regulations on contained use of genetically modified micro-organisms (AFS 2011:2), (Swedish)

How to notify or apply for a permit

1. Fill in information on
  - the organisation which is to use the GMM: name, address and business identity code
  - what advice you have received from a biosafety committee or equivalent
  - the street address of the premises where you are to use the GMM
  - your activity and the nature of your activity
  - how you will manage waste.
    
    Notifications
    
    Notification of F activity (Swedish), Word, opens in a new window
    
    Notification of F activity in waste facility (Swedish), Word, opens in a new window
    
    Notification of L activity (Swedish), Word, opens in a new window
    
    Notification of new use of GMM in current L activity (Swedish), Word, opens in a new window
    
    Permit
    
    Notification of permit of R activity (Swedish), Word, opens in a new window
    Notification of permit of new use of GMM in current R activity (Swedish), Word, opens in a new window
    
    Update of use
    Update of GMM activity (Swedish), Word, opens in a new window
2. Submit the form(s) and the annex on the workplace investigation
  Submit the form by email to
  
  registrator@av.se
  
  Attach a summary of the workplace investigation. Send it as an attachment, for example in Word file or pdf.
If the notification or application does not contain all the information necessary, we will get in touch with the contact person and request supplementation. We will contact you primarily by email.
Once the notification or application is complete, we will process it. You will receive a response within
- 45 days if the notification relates to a new F activity, a new L activity or a new use in an existing L activity
- 90 days if the application relates to a new R activity
- 45 days if the application relates to a new use in an existing R activity.
If we choose not to grant permission, you may appeal the decision. Our notice will set out how you should do so. Set out why you consider that we should change our decision. Send your appeal to the Swedish Work Environment Authority.

We will decide whether to reassess your application.

We will first decide whether to reassess your notification. If we do so and decide to change our initial decision, we will notify you of this.

If we do not reassess the notification, the appeal will be brought before a court of law.

The Swedish Work Environment Authority will refer the appeal on to a court of law, that is to say the Property and Environmental Affairs Court. We will also send in your application and all other documents in your case.

The court will make a decision

The court will adopt a position on your appeal and make a decision. You will receive notice directly from the court.

Law and rules on GMM

Our Swedish rules are based on Directive 2009/41/EC of the European Parliament and of the Council, which lays down the requirements on notification and permission. The Swedish rules are to be found, inter alia, in

The Swedish Environmental Code, Swedish Environmental Protection Agency, opens in a new window

Regulation on contained use of genetically modified micro-organisms (2000:271), (Swedish), Swedish Government website, opens in a new window

The Swedish Work Environment Authority's regulations on contained use of genetically modified micro-organisms (AFS 2011:2), (Swedish)

Last updated 2023-03-07