University of Oulu

Classification and reporting of severity experienced by animals used in scientific procedures : FELASA/ECLAM/ESLAV working group report. David Smith, David Anderson, Anne-Dominique Degryse, Carla Bol, Ana Criado, Alessia Ferrara, Nuno Henrique Franco, Istvan Gyertyan, Jose M Orellana, Grete Ostergaard, Orsolya Varga, Hanna-Marja Voipio. Laboratory Animals Vol 52, Issue 1_suppl, pp. 5 - 57 First Published January 23, 2018,

Classification and reporting of severity experienced by animals used in scientific procedures : FELASA/ECLAM/ESLAV working group report

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Author: Smith, David1; Anderson, David2; Degryse, Anne-Dominique3;
Organizations: 1FELASA, Federation for Laboratory Animal Science Associations, Eye, Suffolk, UK
2LASA, PO Box 524, Hull, HU9 9HE, UK
3Domaine de Mirabel, Puylaurens, France
4Charles River Laboratories, ’s-Hertogenbosch, the Netherlands
5Via Fleming 4, Verona, Italy
6Aptuit, Verona, Italy
7Instituto de Investigacao e Inovacao, Universidade do Porto, Portugal
8Semmelweis University, Budapest, Hungary
9Universidad de Alcala Campus, Universitario Alcala de Henares, Madrid, Spain
10University of Copenhagen, Denmark
11University of Debrecen, Hungary
12University of Oulu, Finland
Format: article
Version: published version
Access: open
Online Access: PDF Full Text (PDF, 0.5 MB)
Persistent link:
Language: English
Published: SAGE Publications, 2018
Publish Date: 2018-03-12


Directive 2010/63/EU introduced requirements for the classification of the severity of procedures to be applied during the project authorisation process to use animals in scientific procedures and also to report actual severity experienced by each animal used in such procedures. These requirements offer opportunities during the design, conduct and reporting of procedures to consider the adverse effects of procedures and how these can be reduced to minimize the welfare consequences for the animals. Better recording and reporting of adverse effects should also help in highlighting priorities for refinement of future similar procedures and benchmarking good practice. Reporting of actual severity should help inform the public of the relative severity of different areas of scientific research and, over time, may show trends regarding refinement. Consistency of assignment of severity categories across Member States is a key requirement, particularly if re-use is considered, or the safeguard clause is to be invoked. The examples of severity classification given in Annex VIII are limited in number, and have little descriptive power to aid assignment. Additionally, the examples given often relate to the procedure and do not attempt to assess the outcome, such as adverse effects that may occur. The aim of this report is to deliver guidance on the assignment of severity, both prospectively and at the end of a procedure. A number of animal models, in current use, have been used to illustrate the severity assessment process from inception of the project, through monitoring during the course of the procedure to the final assessment of actual severity at the end of the procedure (Appendix 1).

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Series: Laboratory animals
ISSN: 0023-6772
ISSN-E: 1758-1117
ISSN-L: 0023-6772
Volume: 52
Issue: 1S
Pages: 5 - 57
DOI: 10.1177/0023677217744587
Type of Publication: A1 Journal article – refereed
Field of Science: 119 Other natural sciences
Funding: Publication of our work was supported by a bursary from Laboratory Animals Limited.
Copyright information: © The Author(s) 2018. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (