Animal research can only be carried out in the EU when there is no suitable non-animal alternative. All project proposals that require the use of animals also have to be approved by the ethics committee at each institution that conducts animal research. The research will not be allowed if the potential benefits of research do not outweigh the suffering that might be experienced by the animals used.
Which regulations are applied to animal research in the European Union?
Animal research in the European Union (EU) is strictly regulated under Directive 2010/63/EU on the protection of animals used for scientific purposes, which is also closely followed in non-EU countries such as Switzerland, the UK and Norway. The Directive’s aim is to protect animals used in research by regulating both the use and care of these animals. No procedure is allowed to be carried out without justification and formal approval by national authorities. Besides the Directive, the transport of animals is regulated by a separate regulation (Council Regulation (EC) No 1/2005, currently under revision); the testing of chemicals and other substances is regulated via dedicated laws and guidelines; and there is a ban on animal testing for cosmetics in place in the EU.
Similar standards to ensure the proper regulation and welfare of research animals exist in many other parts of the world, such as the USA, Australia and South Korea.
Directive and other relevant regulations
How can a research project be approved?
Compliance with the Directive is ensured by a layered system and animal research needs to be approved on different organisational levels:
- Institutional license - Organisations that breed, supply or use animals for scientific purposes need to be authorised to do so. The local competent authorities grant licenses to institutions if they have appropriate facilities and staff that comply with the welfare and housing standards of the Directive. The wide range of general and species-specific requirements are set out in Annex III of the Directive.
- Certified staff – Every individual working with research animals must have the right certification depending on their role: carrying out experimental procedures, designing procedures and projects, taking care of the animals or euthanising animals.
- Project licenses – Individual research projects have to be authorised by the local competent authority before they can start. Project applications follow a pre-defined template and include extensive details on procedures and schedules, scientific explanations, ethical considerations and a non-technical summary of the project (see the EARA feature, ‘Non-technical summaries explained’). An important component of this assessment is the ‘harm-benefit analysis’ by which the competent authorities assess if the potential outcomes of a project outweigh the harm done to the animals. Once approved, any changes to protocols that deviate from the granted project license require filing an amendment with the competent authority.
- Retrospective assessment – In certain cases, a retrospective assessment is required at the end of a project, specifically for projects involving non-human primates and with procedures classified as ‘severe’. This assessment includes whether the objectives of the project were achieved and the actual severity of the procedures as carried out.
- Inspections – Member States are obliged to carry out regular inspections, including inspections of at least one third of all users each year. A portion of these inspections must be unannounced. The inspections are carried out by the competent authorities.
Who does what?
What is a procedure and how are they authorised?
The Directive defines an animal procedure as an action that leads to a level of pain, suffering, distress or lasting harm that is equivalent to or higher than an injection with a needle (as performed by a skilled professional). When such procedures are performed for scientific purposes, they count as a procedure under the Directive, while the identical procedure will not count as an animal experiment if performed in a veterinary clinic.
For example:
Procedures on animals for scientific purposes are subject to the Directive and therefore can only be performed with permission and under the conditions stated in the Directive.
- Observing animals in the wild from a distance without any interaction is not considered an animal experiment, while doing a small surgery to implant a tracking device in wild animals to study their behaviour is.
- Killing an animal (using specified, approved methods) without any preceding procedure solely to make use of its tissues in a study is not considered an animal experiment according to the EU-definition. Some EU Member States have a stricter definition of “animal experiment” that includes killing the animal without any preceding procedures.
- Blood sampling of your pet dog at a veterinary clinic as part of diagnosis or treatment is not considered an animal experiment, while blood sampling of a dog for testing that a new dog medication is safe and effective is considered an animal experiment.
How are procedures classified?
The level of pain, suffering, distress, or lasting harm that is experienced by an animal during or as the result of a procedure is taken into account by the Directive. Which severity level applies for an animal depends on the predicted cumulative severity across the animal’s lifetime.
In practice, there are four levels of severity for procedures: non-recovery, mild, moderate and severe.
How is the distribution of severity of procedures in the EU? Click to see the data.
Severity plays a central role in project authorisation, as the authorities assess whether the expected severity is justified by the expected benefits. Severe procedures are highly restricted and require exceptional justification. The predicted severity of procedures also dictates what measures should be taken by the researchers and animal caretakers to minimise pain, suffering and distress.
Severity is assessed in advance (predicted severity) in the project licence application and during the study (actual severity). Animals must never experience a level of suffering greater than what has been authorised.
With a higher predicted severity, stronger safeguards are needed to relieve pain and monitor animal welfare. In the project licence application, clear humane endpoints are agreed upon. These endpoints indicate when animals should be removed from a procedure, receive certain treatment or pain relief or be euthanised before unnecessary suffering occurs.
You can find the predicted and retrospective (actual) severity levels of procedures of approved projects as part of the non-technical summary in the ALURES database.
What are genetically altered animals?
There is a vast array of diseases and disorders which stem from the (dys-)function of genes. By altering the genetics of an animal, the various functions of different genes can be identified more easily. Researchers may add in a new gene, silence or remove an existing gene, or edit an existing gene. Genetically altered animals (GAA) can contribute to our understanding of how animals and humans develop and function, as these identified genes, or similar genes, are often also present in humans. They can also help in the development of diagnostics, treatments and preventive strategies.
How are genetic alterations made? Click to learn about the common methods.
How many animals are genetically-altered in the EU? Click to see the data.
How is the use of GAA in research regulated?
The use of genetically altered animals also raises important ethical and welfare considerations. Genetic modification may unintentionally cause pain, suffering, or long-term health issues. Animals may only be genetically altered for research purposes under strict conditions set out in Directive 2010/63/EU.
Breeding genetically altered animals is classified as a procedure, with its severity level depending on whether the alteration is expected to have an effect on the animal’s wellbeing. Any potential harm to the animal is carefully weighed against the anticipated scientific or medical benefit, and animals are closely monitored throughout their lives. Breeding lines that develop unexpected harmful effects may be refined, restricted, or discontinued.
Which animals can be genetically altered?
In the EU, great apes are the only animal species that is banned outright from genetic alteration; however, genetic alternation of other species does require strong scientific justification, particularly for larger animal species. This means that genetic editing is performed almost exclusively on the smaller animals more commonly used in procedures: mice, zebrafish and fruit flies (the latter not being classified as an experimental animal under the Directive). Like any procedure, all projects involving genetically altered animals must comply with the principles of the 3Rs.