Francesca Arena European Commission Health and Consumers Directorate General
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Transcript of Francesca Arena European Commission Health and Consumers Directorate General
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Francesca ArenaEuropean Commission
Health and Consumers Directorate General
Future data requirements related to bees for the authorisation of
plant protection products
European Parliament23 March 2011
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OutlineLegislation on plant protection productsData requirements
Current and future
Risk assessmentCriteria approval/uniform principles
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Plant Protection Products EU legislation
Directive91/414/EEC
Directive91/414/EEC
Regulation1107/2009
from 14 June 2011
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Dual system of pre-marketing authorisation
European Union assessment ofactive substances for possible
approval
Member State authorisation of plantprotection products containing
these active substances
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DIRECTIVE 91/414/EEC
Active substancesHarmonised data Harmonised data requirementsrequirements
Plant protection products
Harmonised Harmonised Uniform principlesUniform principles Plant protection products
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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
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National authorisation of PPP
Applicant
Dossier on PPP
Member State
Evaluation Decision
BASED on data requirements
Risk assessment scheme
Uniform principles
Member State
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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
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Directive91/414/EEC Regulation
1107/2009
Revision started under Dir 91/414/EEC, but….
Transfer of current data requirementsby 14 June 2011
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June 2011
Regulation 1107/2009applicable
Old data requirements applicable
New data requirements
Vote new data req.
December2011
January 2012
Application
2013-2014
July 2011
Publication
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HoneybeesCurrent data requirements
Active substancesAcute toxicity test (laboratory)Bee brood (honeybee larvae) (lab/semi-field)
Plant protection productsAcute toxicity test (laboratory)Residue test (laboratory)Cage/tunnel test (semi-field)Field test (field)
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HoneybeesCurrent risk assessment scheme
Based on EPPO standardUpdated December 2010Now covers systemic compoundsCriticisms raised by EU beekeepers and EP
Based on tiered approachSo far first tier based on a trigger value (Hazard quotient - HQ)HQ recognised not suitable for systemic compounds
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HoneybeesShortcomings
Measure broad range of sub-lethal effects to evaluate the colony performanceDefine and standardise sublethal effect measurement endpointsStandardise field tests and increase their statistical power to detect sublethal effects
Testing protocols to be improved!
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HoneybeesShortcomings
Risk from drift of dustExpression of pesticides in nectar and pollen, water, plant guttation and accumulation
Exposure scenarios
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HoneybeesNew (draft) data requirements
Active substancesAcute toxicity test (laboratory)Chronic toxicity test (laboratory)Bee brood (honeybee larvae) (lab/semi-field)
Plant protection productsAcute toxicity test (laboratory)Cage/tunnel test (semi-field)Field test (field)
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HoneybeesNew (draft) data requirements
Emphasis addedNeed to develop new test guidelines at different life stagesAgree on a revised risk assessment
Acute and chronic toxicityNew endpoints (LD50, NOEC)
Investigate lethal and sublethal effects
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HoneybeesNew (draft) data requirements
Seed treatments, soil applicationsEvaluate risk from drift of dust
Systemic pesticidesData on residues in pollen, nectar and water (incl. guttation) required
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New data requirements
Regulation (data requirements)
Communication (test guidelines)
More flexible structure
updated more frequently
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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
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Uniform principles (Dir. 91/414/EEC)
Short term and long-term risk Lethal and sub-lethal effectsReduction in activity
No long-term repercussions for the abundance and diversity of non-target species
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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
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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/pesticidespromote non-chemical methods
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Conclusions
Improved data requirements, but future changes are not excludedNew risk assessment scheme (EFSA)Need to develop new protocolsNew criteria in Regulation (EC) No 1107/2009 / sustainable use of pesticides