Laws and regulations on animal experimentation

Here you find the Swedish and European laws and regulations on animal experimentation, as well as local KI regulations.

The care and use of 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 research animals. Replacement (if valid replacement methods exist an application 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 research animals.

Ethical approvals

Animal experiments can only be performed if there is an ethical approval which is granted by an ethics committee. The approval is valid up to five years. It is the research group leader/project leader who submits the application for ethical evaulation of animal experiments. Ethical evaluation of animal experiments

Experiments conducted under a approval must be kept in an animal journal.

Educational requirements

Experiments may only be executed by staff/researchers that have the necessary formal training (procedure license) in Laboratory Animal Science. Educational requirements for animal experimentation

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 approval that is legally responsible for all activities covered by the approval.

Each establisment license (for one or more facilities) has a named officer and laboratory animal veterinarian (installed by the Government competent authority). It is the named officer who shall supervise that the work and use of research animals are in accord with the legislation. If there are several named officers and/or veterinarians, their respective areas of responsibility shall be specified in delegations.

In addition to the establishment license, each facility are provided with a license to house and use research 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 named officer.

In addition,inspectors of the County Administrative Board do regular audits and the inspector can close down the facility if its operations do not comply with the legislation.

List of governing laws, regulations and policies

Swedish laws and regulations on animal experimentation (in Swedish)

EU directives and conventions

2010/63/EU. COUNCIL DIRECTIVE of 22 September 2010 on the protection of animals used for scientific purposes. Implemented January 1, 2013