The Swedish legislation on genetic engineering is based on two EC Directives: Directive 2009/41/EG on the contained use of genetically modified micro-organisms, and Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms. EC directives do not automatically apply in Sweden. They must first be transposed into Swedish law.
Contained use of GMOs other than GMMs is regulated by national legislation only.
The use of GMOs in Sweden is regulated in chapter 13 of the Swedish Environmental Code. Other provisions of this Code are also relevant to the use of GMOs, such as the general rules of consideration in chapter 2 and the provisions on biotechnical organisms in chapter 14. The purpose of the rules is to protect human health and the environment and to ensure that particular attention is paid to ethical concerns in connection with genetic engineering activities.
The Swedish Environmental Code is supplemented by a number of ordinances and regulations. The Genetically Modified Organisms (Deliberate Release) Ordinance (SFS 2002:1086) and the Genetically Modified Organisms (Contained Use) Ordinance (SFS 2000:271) set out more detailed rules on when consents or notifications are required for genetic engineering activities.
Different authorities have a supervisory role in relation to different categories of organisms and different types of uses. These authorities issue the regulations laying down the requirements to be met by the activities concerned. They also examine the information submitted by users and inspect activities involving GMOs.
The information to be supplied in a notification or application relating to contained use of GMOs is specified in the supervisory authorities' regulations, while the particulars to be provided in applications concerning deliberate releases and placing on the market are set out in SFS 2002:1086.
In addition to the EC directives and the Swedish Environmental code there are EC regulations concerning GMOs. EC regulations are directly applicable, without prior incorporation into Swedish legislation. Regulation (EC) No 1829/2003 applies when human food or animal feed contains, consists of or has been produced from GMOs. Regulation (EC) No 1830/2003 concernes the traceability and labelling of GMOs. The regulation on transboundary movements of genetically modified organisms (EC) No 1946/2003, implements the UN Biosafety Protocol into EC law.
All medicinal products, whether or not they contain GMOs, have to undergo a range of tests before they can be approved. Medicines containing GMOs are regulated in the Swedish Medicinal Products Act (SFS 1992:859) and Regulation (EC) No 726/2004. Further details can be found on the Swedish Medical Products Agency's website. It should be noted that pre-approval trials of such medicines may also involve contained use of GMOs.
The use of gene technology on humans is regulated by the Act concerning the Use of Certain Genetic Technology in Medical Screening (SFS 1991:114) and the Act concerning Measures for Purposes of Research or Treatment involving Human Ova (SFS 1991:115). These issues fall within the remit of the National Board of Health and Welfare.