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Directive 2010/63/EU of the European Parliament and of the CouncilShow full title

Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (Text with EEA relevance)

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Section II: Assignment criteria

The assignment of the severity category shall take into account any intervention or manipulation of an animal within a defined procedure. It shall be based on the most severe effects likely to be experienced by an individual animal after applying all appropriate refinement techniques.

When assigning a procedure to a particular category, the type of procedure and a number of other factors shall be taken into account. All these factors shall be considered on a case-by-case basis.

The factors related to the procedure shall include:

  • type of manipulation, handling,

  • nature of pain, suffering, distress or lasting harm caused by (all elements of) the procedure, and its intensity, the duration, frequency and multiplicity of techniques employed,

  • cumulative suffering within a procedure,

  • prevention from expressing natural behaviour including restrictions on the housing, husbandry and care standards.

Examples are given in Section III of procedures assigned to each of the severity categories on the basis of factors related to the type of the procedure alone. They shall provide the first indication as to what classification would be the most appropriate for a certain type of procedure.

However, for the purposes of the final severity classification of the procedure, the following additional factors, assessed on a case-by-case basis, shall also be taken into account:

  • type of species and genotype,

  • maturity, age and gender of the animal,

  • training experience of the animal with respect to the procedure,

  • if the animal is to be reused, the actual severity of the previous procedures,

  • the methods used to reduce or eliminate pain, suffering and distress, including refinement of housing, husbandry and care conditions,

  • humane end-points.

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