Genetic engineering – contained use of GMMs
This information is intended for those whose activities involve the contained use of GMMs. This section explains how to notify your activities and investigate and assess the risks posed by contained use.
In genetically modified microorganisms (GMMs), the genetic material has been altered using certain techniques. The rules on GMMs also cover genetically modified cells from higher organisms when they occur in cell culture. Contained use of GMMs takes place in research laboratories and in industry to develop enzymes and other biotechnological products.
This section provides information on the rules governing the contained use of GMMs and how they relate to health and safety rules. The forms you need to notify or apply for a permission regarding your GMM activities are also available on these pages.
All contained use of GMMs must be notified to the Swedish Work Environment Authority
Contained use of GMMs must take place in a GMM business that has been notified to or has a permit from the Swedish Work Environment Authority.
The rules can be found in the Environmental Code, the Regulation on the contained use of genetically modified organisms (2000:271) and in the Swedish Work Environment Authority’s regulations on the contained use of genetically modified microorganisms (AFS 2011:2).
All contained use of GMMs must be notified to the Swedish Work Environment Authority. In some cases, a permit is also required. In the EU and in Sweden, it is believed that the precautionary principle should be applied to all uses of genetic engineering. The domestic rules are based on an EU Directive, where the requirements for notifications and permits can be found. More information on how to register your GMM activity is available on the ‘notifications and permits for GMM activities’ page.
The use of other genetically modified organisms (GMOs), such as plants or experimental animals, is regulated by other authorities.
Contained use of aquatic GMOs, such as zebrafish, is regulated by the Swedish Agency for Maritime and Water Management.
Contained use of GMOs other than GMMs and aquatic GMOs is regulated by the Swedish Board of Agriculture.
Clinical trials of GMO drugs are regulated by the Swedish Medical Products Agency.
What is the difference between GMOs, GMMs and transgenic organisms?
Genetically modified organisms (GMOs) and microorganisms (GMMs) are sometimes referred to as transgenic, genetically altered or genetically manipulated organisms. Other terms also exist, but on these pages we only use the terms GMO and GMM. Sometimes GMOs that are plants are called GM plants and GMOs that are animals are called GM animals. You can read more about the legal definition of GMMs on the ‘Legislation and definitions of genetic engineering, GMMs’ page.
GMOs and GMMs are not entirely the same thing. GMMs are GMOs that are microorganisms. Therefore, in most cases, a GMM is covered by the term GMO, but not the other way round. More information on all Swedish genetic engineering legislation in popular form can be found on the pages regarding legislation on the Genetics Committee’s information pages, Genteknik.nu.
Legislation on both the environment and occupational safety
The Environmental Code (1998:808) is the overarching environmental legislation in the same way as the Work Environment Act (1977:1160) governs occupational health and safety. Both laws apply in parallel. This means that you must comply with both laws. The overarching legislation includes various regulations, such as the Regulation on the contained use of genetically modified organisms (2000:271).
Since the contained use of GMMs in accordance with environmental legislation is at the same time the use of biological agents under the occupational health and safety legislation, the Swedish Work Environment Authority has been assigned supervisory responsibility for both laws. The regulations on the contained use of GMMs (AFS 2011:2) have been harmonised with the regulations on risk of infection (AFS 2018:4), so that conflicts do not arise between the regulations. To a large extent they overlap, but they cannot replace each other.
Last updated 2020-12-30