Animal research and the law

In 2022 there were 84 establishments in Norway with approval to carry out animal experiments and three suppliers of animals for research (Food Safety Authority, personal communication). According to the Norwegian Food Safety Authority's Annual Report for 2021 there were 79 approved animal research establishments in Norway that year, and a total of 432 applications for animal research were approved. The annual reports from the Food Safety Authority's Animal Research Team are available here, while the annual reports from the Food Safety Authority itself can be read here.

The legal framework for the use of animals in research in Norway changed dramatically in 2015 as a result of a new EU Directive.

In this section we describe

• EU-directive 2010/63
• Norwegian legislation and its regulation
• Statistics of the use of animals in Norway and abroad

See also the European Convention ETS 123

The legislation in Nordic countries (Norway, Sweden, Denmark, Finland) and Estonia is compared in this paper:
Arney D, Louhimies S, Knudsen S, Lund L, Kabel K, Peuranen S, Kaliste E, Knudsen G & Cvek K (2023): Project evaluation in animal research – Possibilities for Harmonization in Nordic Countries. Scandinavian Journal of Laboratory Animal Science, 49, 6–13.

Specific legislation on fish research can be accessed here. 

Information about Norway's National Committee for the Protection of Animals used for Scientific Purposes

We have also constructed the PREPARE guidelines with links to resources which will be of help from day 1 when animal research and testing is being planned.

When planning animal experiments, it is just as important to consider ethical implications as to adhere to the legislation. A Harm-Benefit Analysis is an important part of this.

The UK Home Office and UK organisations have produced much guidance about animal research, much of which is also relevant in other countries. This includes:

• Advice on the role of lay members in ethical review committees
• Understanding animal experiments and procedures
• UK Government overview of the British legislation on research and testing using animals, and guidance documents
• Code of practice and working protocol for the UK Animals in Science Committee (ASC). Minutes and members
• The UK Animals in Science Regulation Unit (ASRU) has published guidance that explains how the act is administered and enforced including detailed regulatory advice for licence holders. This includes:
  • household products testing ban
  • guidance on the use of human material in animals
  • use, keeping alive and re-use
  • harm-benefit analysis
  • re-homing and setting free
  • working with animals taken from the wild
  • code of practice for the care and accommodation of animals
  • efficient breeding of genetically altered animals
  • severity classification of genetically altered animals
  • recording and reporting the actual severity of regulated procedures
  • process and standards for establishment full system audits
  • Non-human primates used in service-licences
• Non-Technical Summaries approved in the UK
• The NC3Rs has produced webpages for project licence applicants, with advice on each of the three Rs.
• The RSPCA has produced guidance for Animal Welfare and Ethical Review Bodies (AWERBs)
• EU guidance document on animal welfare bodies and national committees
• EU guidance document on non-technical project summaries
• EU guidance document on inspections and enforcement
• EU guidance document on genetically altered animals
• EU guidance document on project evaluation and retrospective assessment
• EU guidance document on severity assessment framework
• EU guidance document on education and training framework 
• Guide to writing Non-Technical Summaries (NTS) from Understanding Animal Research (UAR)
• Non-Technical Summaries Explained by the European Animal Research Association (EARA)
• Checklists to support UK funding bodies, to ensure animal research carried out overseas is conducted to appropriate standards of welfare 

Regulatory Framework and Harmonisation of the Care and Use of Animals in Research: a presentation by Javier Guillén (2018) describing European legislation, including comparisons with North American and Australian legislation

Laboratory Animals: Regulations and Recommendations for the Care and Use of Animals in Research (a textbook edited by Javier Guillén giving a global overview of regulations, guidelines and recommendations for laboratory animal research)

An overview of legislation in different countries, provided by FRAME

The Use of Animals in Research and Testing - an infographic from the RSPCA, showing global figures and the licences necessary for UK use

A collection of regulations and resources by country, compiled by AAALAC International

UK Centre for Animal Law

Recommendations to improve the EU non-technical summaries of animal experiments

EU regulations on animal research - a commentary by EARA (European Animal Research Association) 

Overviews from Speaking of Research about animal research legislation in the United States, the United Kingdom and the European Union.

Animal Protection Index (API): a ranking of 50 countries according to their animal welfare policy and legislation.

Further reading

Authorization of Animal Experiments is Based on Confidence Rather than Evidence of Scientific Rigor (Vogt et al., 2016)
Swiss system for recording licence applications, reports and announcements: animex-ch

Historically, the Home Office published comprehensive guidance on how to apply for project licences, including an annotated project licence application form but the former has been withdrawn and the latter is no longer being updated.