Applying the 3Rs in EFSA’s risk assessments
EFSA supports risk assessment approaches which minimise and refine the use of experimental animals (in-vivo testing) and that promote use of data derived from alternative approaches, where possible. These alternatives include lab tests in tubes, flasks, petri dishes, etc. (in vitro) or performed via computer simulation (in silico).
EFSA is committed to the internationally established principles of the 3Rs – replacement, reduction and refinement of animal testing.
EFSA will continue to improve existing guidance documents and procedures, where appropriate, in cooperation with the EU risk managers on the implementation of alternative methods.
The Authority publishes recommendations and scientific outputs relevant to the application of the 3Rs principles in its risk assessments when relevant.
EFSA’s Panel on Animal Health and Welfare (AHAW) has published a scientific opinion on the welfare of animals used for experimental and other scientific purposes and recommended ways to promote better animal welfare.
The Panel has provided guidance on criteria to evaluate studies on new stunning methods for food producing animals. The guidance helps avoid unnecessary use of experimental animals in such studies.
EFSA’s Scientific Committee has identified possibilities for replacement, reduction and refinement of animal testing within EFSA’s scientific assessment activities.
The Committee has also reviewed alternative methodologies that can be used to assess the safety of chemicals and can reduce animal use in toxicological research. These include in vitro and in silico methods that can be useful for investigating toxicokinetic (what the body does to a chemical) and toxicodynamic processes in humans (what the chemical does to the body) and predict the toxicity of chemicals.
The Scientific Committee has also provided guidance for carrying out feeding trials related to applications for novel foods and for food and feed derived from genetically modified plants. The guidance outlines experimental designs aimed at ensuring relevant results while minimising the number of animals to be used.
In the field of risk assessment of food additives and pesticides, EFSA has adopted a “tiered approach” that guides applicants in designing their toxicological testing strategy. Decisions are based and justified on scientific evaluation of the results in stages. Such an approach can result in the need for fewer or more refined animal tests.
Guidance documents developed by the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) encourage the use of in vitro methods or of methods refining or replacing tests using laboratory animals or reducing the number of animals used. For example, in vitro methods are encouraged in the assessment of the safety of feed additives for the food handler (e.g farm workers).
EU legislation on the protection of animals used for scientific purposes identifies guiding principles for the ethical use of animals in experimental procedures (Directive 2010/63/EU). These are the 3Rs:
- Replacement: the use of non-animal methods over animal methods whenever possible to achieve the same scientific aim.
- Reduction: methods that enable researchers to obtain comparable levels of information from fewer animals, or to obtain more information from the same number of animals.
- Refinement: methods that alleviate or minimise potential pain, suffering, or distress, in the animals used.