GMO REGULATIONS IN SWEDEN
WEBSITE OF THE AUTHORITIES RESPONSIBLE FOR THE REGULATIONS OF ACTIVITITES INVOLVING GMOs

Distribution of responsibilities between the authorities

Any activity concerning GMOs requires the submission of a notification or permit application to the relevant sectoral authority. The various authorities have issued their own regulations stipulating what information is to be given in a notification or application. The requirements vary according to the organism and the type of activity involved. Any charges are payable by the notifier or applicant. For further details, readers are referred to the authorities concerned and their regulations. The areas of responsibility of the different sectoral authorities, as laid down in the Ordinance on Supervision under the Swedish Environmental Code (SFS 1998:900), are as follows:

The Swedish Work Environment Authority

Contained use of genetically modified micro-organisms, including cell cultures of higher organisms.

The Swedish agency for marine and water management

Contained use of aquatic genetically modified organisms, except for aquatic genetically modified micro-organisms.

Deliberate release of aquatic genetically modified organisms.

Placing on the market of products containing or consisting of aquatic genetically modified organisms.

The Swedish Chemicals Agency

Deliberate release of genetically modified micro-organisms, nematodes, arachnids and insects.

Placing on the market of products containing or consisting of genetically modified micro-organisms, nematodes, arachnids and insects.

The National Food Administration

Placing on the market of foods consisting of or containing genetically modified organisms.

Placing on the market of medicinal products containing or consisting of genetically modified organisms.

The National Board of Forestry

Deliberate release of genetically modified forest trees intended for timber production.

Placing on the market of genetically modified forest trees intended for timber production.

The Swedish Board of Agriculture

Contained use of other genetically modified organisms.

Deliberate release of other genetically modified organisms.

Placing on the market of other genetically modified organisms and of animal feed containing genetically modified organisms.

The Swedish Gene Technology Advisory Board
The functions of the Gene Technology Advisory Board are regulated by chapter 13, section 19, of the Swedish Environmental Code and by the Ordinance concerning the Duties of the Gene Technology Advisory Board (SFS 2007:1075). The Board monitors national and international developments in genetic engineering, reviews ethical issues arising in this field, and gives advice aiming to promote ethically justifiable and safe use of genetic engineering, in order to protect human health and the environment.

The Ordinance on Deliberate Release into the Environment of Genetically Modified Organisms (SFS 2002:1086) requires the various sectoral authorities to consult the Gene Technology Advisory Board when drawing up regulations and considering permit applications relating to the deliberate release in Sweden of new GMOs or of previously used GMOs under substantially new conditions.

The Swedish Environmental Protection Agency
The Ordinance on Deliberate Release into the Environment of Genetically Modified Organisms (SFS 2002:1086) and the Ordinance on Contained Use of Genetically Modified Organisms (SFS 2000:271) state that the Environmental Protection Agency is to be consulted when a sectoral authority adopts regulations or takes decisions on new, untried releases. The Agency is also to be informed of decisions on consents under Directive 2001/18/EC.

The Swedish Civil Contingencies Agency
The Swedish Civil Contingencies Agency, MSNB, is responsible for matters related to civil protection, emergency and civil defence.
One of MSB´s responsibilities is to implement regulations concerning safety in relation to the transport by road and rail, e.g. for such genetically modified organisms and micro organisms that have been classified as dangerous goods. The agency is to be consulted when a sectoral authority adopts regulations concerning transportation of GMOs.