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Francesca Arena European Commission Health and Consumers Directorate General

Future data requirements related to bees for the authorisation of plant protection products. Francesca Arena European Commission Health and Consumers Directorate General. European Parliament 23 March 2011. Outline. Legislation on plant protection products Data requirements Current and future

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Francesca Arena European Commission Health and Consumers Directorate General

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  1. Future data requirements related to bees for the authorisation of plant protection products Francesca ArenaEuropean CommissionHealth and Consumers Directorate General European Parliament23 March 2011

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

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

  4. 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

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

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

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

  8. Harmonised data requirements 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) …. now under revision

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

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

  11. HoneybeesCurrent 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)

  12. HoneybeesCurrent 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

  13. HoneybeesShortcomings • 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!

  14. HoneybeesShortcomings • Risk from drift of dust • Expression of pesticides in nectar and pollen, water, plant guttation and accumulation Exposure scenarios

  15. HoneybeesNew (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)

  16. HoneybeesNew (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

  17. HoneybeesNew (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

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

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

  20. 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

  21. Regulation (EC) No 1107/2009 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

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

  23. 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

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