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.