Laws and regulations on animal experimentation
This page describes the Swedish and European laws and regulations on animal experimentation, as well as local KI regulations.
The care and use of laboratory animals in research is regulated under a common law frame across the EU (Directive 2010/63/EU). The Swedish legislation was adjusted to the EU directive in 2013.
The EU directive puts more emphasis on species-specific education and training in laboratory animal science, and the implementation of the 3R’s in every aspect of care and use of laboratory animals. Replacement (if valid replacement methods exist a permit is not granted), refinement (reducing discomfort and stress wherever it is possible) and reduction must be considered in every aspect of a project involving the use of lab animals.
Animal experiments can only be performed if there is an ethical permit/ethical license which is granted by an ethical committee. The permit is valid up to 5 years and can comprise several projects. It is the research group leader/project leader who submits the application for ethical evaulation of animal experiments.
Experiments conducted under a license should be kept in an animal record.
Experiments may only be executed by staff/researchers that have the necessary formal training (procedure license) in Laboratory Animal Science.
Multiple persons (researchers and technicians) may perform practical tasks within a project, including various invasive procedures. All such staff and researchers must be identified in the project plan or animal record, and each person must possess the relevant procedure license(s).
Roles and responsibilities
It is the holder (Principal investigator/Project director) of the ethical permit that is legally responsible for all activities covered by the ethical license.
Each facility has a designated superintendent (installed by the Government competent authority) and it is she/he who shall supervise that the work and use of lab animals are in accord with the legislation.
In addition, inspectors of the County Council do annual audits and the inspector can close down the facility if its operations do not comply with the legislation.
Facilities are provided with a license to house and use laboratory animals; and to house and use Genetically Modified Animals (GMA), both by the Governments Competent Authority. To hold a license the facility must have a designated veterinarian and a designated superintendent.
List of governing laws, regulations and policies
2010/63/EU. COUNCIL DIRECTIVE of 22 September 2010 on the protection of animals used for scientific purposes. Implemented January 1, 2013
European Treaty Series (from "2003 Council of Europe Treaty Series") (CETS)
Swedish Laws and Regulations on animal experimentation (in Swedish)
The Animal Welfare Act
(L 1 Djurskyddslagen SFS 1988:534)
The Animal Welfare Ordinance
(L 2 Djurskyddsförordningen SFS 1988:539)
The Swedish Board of Agriculture’s Regulations and General Advice of Laboratory Animals
(L150 Statens jordbruksverks föreskrifter och allmänna råd om försöksdjur SJVFS 2015:24)
and Changes to the regulations and general advice regarding transport
(L 5 Statens jordbruksverks och allmänna råd om transport av levande djur SJVFS 2010:2 and SJVFS 2010:84)
The Swedish Board of Agriculture’s regulations and general advice regarding fees in certain matters according to 67 § animal welfare ordinance
(L117 Avgifter i vissa ärenden enligt 67 § djurskyddsförordningen SJVFS 2015:23)
Karolinska Institutet’s Rules and Regulations
(in Swedish) (Kompletterande regler för anskaffande och användning av försöksdjur Dnr 1937/03-640)