2. Francesca Arena European Commission Health and Consumers Directorate General Future data requirements related to bees for the authorisation of plant protection products European Parliament 23 March 2011

3. Outline Legislation on plant protection products Data requirements Current and future Risk assessment Criteria approval/uniform principles

4. Plant Protection Products EU legislation Directive 91/414/EEC Directive 91/414/EEC Regulation 1107/2009 from 14 June 2011

5. Dual system of pre-marketing authorisation European Union assessment of active substances for possible approval Member State authorisation of plant protection products containing these active substances

6. DIRECTIVE 91/414/EEC Active substances Harmonised data requirements Plant protection products Harmonised Uniform principles Plant protection products

7. EU Approval of active substances Applicant Dossier on an active substance MS/ EFSA Evaluation Decision Commission BASED on data requirements Risk assessment scheme Criteria for approval

8. National authorisation of PPP Applicant Dossier on PPP Member State Evaluation Decision BASED on data requirements Risk assessment scheme Uniform principles Member State

9. Developed between 1993 and 1996  Physical and chemical properties (Dir 94/37/EC)  Analytical methods (Dir 94/46/EC)  Efficacy data (Dir 93/71/EC)  Toxicogical studies (Dir 94/79/EC)  Residues in or on treated products, food and feed (Dir 96/68/EC)  Fate and behaviour in the environment (Dir 95/36/EC) Ecotoxicological studies (Dir 96/12/EC) Harmonised data requirements …. now under revision

10. Directive 91/414/EEC Regulation 1107/2009 Revision started under Dir 91/414/EEC, but…. Transfer of current data requirements by 14 June 2011

11. June 2011 Regulation 1107/2009 applicable Old data requirements applicable New data requirements Vote new data req. December 2011 January 2012 Application 2013- 2014 July 2011 Publication

12. Honeybees Current data requirements Active substances Acute toxicity test(laboratory) Bee brood (honeybee larvae)(lab/semi-field) Plant protection products Acute toxicity test(laboratory) Residue test(laboratory) Cage/tunnel test (semi-field) Field test (field)

13. Honeybees Current risk assessment scheme Based on EPPO standard Updated December 2010 Now covers systemic compounds Criticisms raised by EU beekeepers and EP Based on tiered approach So far first tier based on a trigger value (Hazard quotient - HQ) HQ recognised not suitable for systemic compounds

14. Honeybees Shortcomings Measure broad range of sub-lethal effects to evaluate the colony performance Define and standardise sublethal effect measurement endpoints Standardise field tests and increase their statistical power to detect sublethal effects Testing protocols to be improved!

15. Honeybees Shortcomings Risk from drift of dust Expression of pesticides in nectar and pollen, water, plant guttation and accumulation Exposure scenarios

16. Honeybees New (draft) data requirements Active substances Acute toxicity test(laboratory) Chronic toxicity test(laboratory) Bee brood (honeybee larvae)(lab/semi-field) Plant protection products Acute toxicity test(laboratory) Cage/tunnel test (semi-field) Field test (field)

17. Honeybees New (draft) data requirements Emphasis added Need to develop new test guidelines at different life stages Agree on a revised risk assessment Acute and chronic toxicity New endpoints (LD50, NOEC) Investigate lethal and sublethal effects

18. Honeybees New (draft) data requirements Seed treatments, soil applications Evaluate risk from drift of dust Systemic pesticides Data on residues in pollen, nectar and water (incl. guttation) required

19. New data requirements Regulation (data requirements) Communication (test guidelines) More flexible structure updated more frequently

20. EFSA to develop a risk assessment scheme Future risk assessment Acute and Chronic risk (inc. low doses) Cumulative and synergistic effects Evaluation existing testing protocols

21. Uniform principles (Dir. 91/414/EEC) Short term and long-term risk Lethal and sub-lethal effects Reduction in activity No long-term repercussions for the abundance and diversity of non-target species

22. Honeybees New approval criteria No unacceptable acute or chronic effects on colony survival and development, taking into account affects on honeybee larvae and honeybee behaviour Regulation (EC) No 1107/2009

23. Positive impact! Sustainable use of pesticides Directive 2009/128/EC National action plans Integrated pest management by 2014 reduce the risk promote low risk techniques/pesticides promote non-chemical methods

24. Conclusions Improved data requirements, but future changes are not excluded New risk assessment scheme (EFSA) Need to develop new protocols New criteria in Regulation (EC) No 1107/2009 / sustainable use of pesticides