Severity in animal testing

The EU Directive on Animal Experiments (Directive 2010/63/EU), which is implemented in Austria by the Animal Experiments Act 2012 (TVG 2012), creates the legal requirements for research projects in which objectives can only be achieved through the use of laboratory animals. Basically, according to the principles of avoidance, reduction and improvement (Replace-Reduce-Refine/3R), an animal-free method must always be strived for. Provided that no alternative method is available to conduct research for the protection of "human and animal health", as well as for the protection of the environment, animals may only be used under precisely defined legal conditions. The primary objective of this EU Directive is to maximize animal welfare by ensuring the highest possible level of protection and to minimize "pain, suffering or distress".

According to the law, project leaders must submit an application for an animal experiment for a project that involves the use of animals. This application is then reviewed by the Federal Ministry of Education, Science and Research (BMBWF) and approved if all requirements are met. One point of the animal experiment application is the assignment of a severity level. The severity assignment is based, by definition of the TVG 2012, "on the most severe effects to which the animals are likely to be exposed after application of all appropriate ameliorative techniques." To assess severity, any type of "intervention or manipulation of animals in the course of animal experimentation" must be considered, as well as animal-specific factors such as species, genotype, age, sex, etc.

The individual severity levels are precisely defined in §3 of the TVG 2012. Accordingly, the following degrees of severity are distinguished:

• no restoration of vital function: animal experiments conducted entirely under general anesthesia from which the animal does not awaken
• low: animal experiments that are expected to cause minor pain, suffering, or distress to the animals for a short period of time, and animal experiments without significant adverse effects on the welfare or general condition of the animals
• moderate: animal experiments that are expected to cause short-term moderate pain, suffering, or distress in the animals, or long-lasting minor pain, and animal experiments that are expected to cause moderate impairment of the welfare or general condition of the animals
• severe: animal experiments that are expected to cause severe pain, suffering, or distress in animals, or prolonged moderate pain, suffering, or distress, and animal experiments that are expected to cause severe impairment of the welfare or general condition of animals.

The BMBWF provides a listing with examples of the assignment to severity levels. It can be found under the following link: BMBWF_Examples of severity assignment The severity levels are part of the annually published national animal experiment statistics.

In 2023, the next publication of EU-wide statistics will take place. On the website of the BMBWF (Austrian animal experiment statistics) you can access the statistical data of the previous years.

sources: TVG 2012, RL 2010/63/EU