BOX 2-1
Key Features of European Union Directive 2010/63

Chapter I (General Provisions)

•   Widened scope: Specific invertebrates and fetuses in last trimester of development; animals in basic research, education, and training (Art. 2).

•   Formal introduction of 3Rs (reduction, refinement, and replacement) as guiding principles (Art. 4).

•   Limitation of acceptable methods of sacrifice (Art. 6, Annex IV).

Chapter II (Provisions for Certain Animals)

•   Restricted use of endangered species (Art. 7).

•   Restricted use of non-human primates, ban on use of Great Apes (Art. 8).

•   Purpose-bred requirement for most commonly used lab species; F2 requirement for non-human primates (Art. 10, Annex I).

Chapter III (Procedures)

•   Mandatory use of alternatives, reduction, and refinement (Art. 13).

•   Severity classification system, ban on severe studies (Art. 15).

•   Reuse limitations (Art. 16).

Chapter IV (Authorization)

•   Competence of personnel, institutional animal welfare person, designated veterinarian, and animal welfare body (Art. 23, 24, 25, 27).

•   Tasks of animal welfare body (Art. 27).

•   Breeding strategy for non-human primates (Art. 28).

•   Care and accommodation (Art. 33).

•   Inspections, controls of member states inspections (Art. 34, 35).

•   Project authorization, application, evaluation (including ethical considerations), retrospective assessment, granting of authorization, simplified administration procedure (Art. 36).

•   Non-technical project summaries (Art. 43).

Chapter V (Avoidance of Duplication and Alternatives)

•   Mutual data acceptance of member states (Art. 46).

•   Union Reference Laboratory (Art. 48).

•   National committees for laboratory animal protection (Art. 49).

Chapter VI (Final Provisions)

•   Reporting obligations for member states (Art. 54).

•   Safeguard clauses (Art. 55)—Great Apes, most severe studies.

•   Commission report to the European Parliament and the Council—every 5 years after 2019 (Art. 57).

•   Five-year reviews (2017) with special focus on advancements of alternatives— specifically for non-human primates (Art. 58).

SOURCE: Blumer presentation.



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