1. Mark Jones, veterinarian Executive Director Humane Society International/UK Protection of Animals Used for Scientific Purposes: Enforcement Considerations

2. Humane Society International Prevention or alleviation of the suffering of animals

3. HSI Impact areas HSI Animal Testing – EU work areas: Directive 2010/63 Cosmetics REACH Biocides AXLR8 Horizon 2020

4. Order of service Directive 2010/63 EU - overview 3Rs – Compliance – Enforcement challenges – Enforcement opportunities Conclusions

5. Directive 2010/63 EU - overview Article 1: Scope Article 4: 3Rs Article 6: Methods of killing

6. 3Rs - Compliance Article 20: Authorisation of breeders, suppliers and users Article 22: Requirements for installations and equipment Article 38: Project evaluation

7. 3Rs - Enforcement Challenges Choice of methods used in procedures Choice of regulatory test methods Breeding accommodation and care/installations and equipment/killing

8. Infrequent inspections and lack of transparency Article 34 – infrequent inspections Article 54 – limited compulsory reporting Member state transpositions Controls of National Inspections 3Rs - Enforcement Challenges

9. Uniformity of application and interpretation Project evaluation and severity classifications

10. 3Rs – Enforcement Opportunities Networking Education and training National committees Controls of National Inspections Member State Committee

11. 3Rs – Enforcement Opportunities New transparency provisions Article 43 – non-technical project summaries Article 54 – reporting Article 47 – alternative approaches

12. Conclusions ‘Directive 2010/63 will significantly improve animal welfare in the European Union. We will have the highest standards of experimental animal welfare in the world. What is more, and crucially so, these standards will not compromise but rather foster the competitiveness of our research and industry.’ Janez Potocnik, European Commissioner for the Environment, 2010

13. Conclusions Requires: Robust enforcement Culture of compliance Vigilance Transparency

14. Thank you! EUROPEAN UNION hsieurope.org Contact: Emily McIvor (emcivor@hsi.org) This work is supported with a grant from the World Society for the Protection of Animals