Aquatic organisms

Handling genetically modified organisms (GMOs) requires notification to and/or a permit from the Swedish Agency for Marine and Water Management.

• Notification of contained uses of genetically modified aquatic organisms.
• Permit for using a facility for the contained use of genetically modified aquatic organisms.

The Swedish Agency for Marine and Water Management is the supervisory authority for the contained use of genetically modified aquatic organisms, the deliberate release of genetically modified aquatic organisms and the placing of products on the market containing or consisting of genetically modified aquatic organisms. According to the Environmental Code, contained use refers to any activity in which microorganisms are genetically modified or in which such genetically modified microorganisms (GMMs) are cultured, stored, transported, destroyed, disposed of, or used in any other way, and for which specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment.

The contained use of GMOs must be preceded by an investigation to provide a basis by which any possible damage caused by GMOs may be assessed regarding human health and the environment. The investigation must be made following well-tried and scientific experience. A permit decision may be announced no later than 90 days after submitting a complete application. No facility may be used for GMO activities before a permit has been issued. If the activity changes in a way that may have a significant impact on the risks of the activity, those conducting the activity must inform the supervisory authority as soon as possible. The notification obligation also applies if those conducting the activity become aware of circumstances that may have such significance. If information previously provided in a notification or application is no longer correct or has become outdated, the activity operator must ensure that the previously made notification or application is amended or updated in relevant parts. This obligation also applies if the activity has ceased to exist.

An application for approval of an aquaculture facility must also be submitted to the Swedish Board of Agriculture.