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
Francesca Arena European Commission Health and Consumers Directorate General Future data requirements related to bees for the authorisation of plant protection.
Apr 01, 2015
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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
Outline
Legislation on plant protection products
Data requirements
Current and future
Risk assessment
Criteria approval/uniform principles
Plant Protection Products
EU legislation
Directive91/414/EEC
Directive91/414/EEC
Regulation1107/2009
from 14 June 2011
Dual system of pre-marketing authorisation
European Union assessment ofactive substances for possible
approval
Member State authorisation of plantprotection products containing
these active substances
DIRECTIVE 91/414/EEC
Active substancesHarmonised data Harmonised data
requirementsrequirementsPlant protection products
Harmonised Harmonised Uniform principlesUniform principles Plant protection products
EU Approval of active substances
Applicant
Dossier on an active substance
MS/ EFSA
EvaluationDecision
Commission
BASED on data requirements
Risk assessment scheme
Criteria for approval
National authorisation of PPP
Applicant
Dossier on PPP
Member State
Evaluation Decision
BASED on data requirements
Risk assessment scheme
Uniform principles
Member State
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
Directive91/414/EEC
Regulation1107/2009
Revision started under Dir 91/414/EEC, but….
Transfer of current data requirementsby 14 June 2011
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
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)
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
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!
HoneybeesShortcomings
Risk from drift of dustExpression of pesticides in nectar and pollen, water, plant guttation and accumulation
Exposure scenarios
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)
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
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
New data requirements
Regulation (data requirements)
Communication (test guidelines)
More flexible structure
updated more frequently
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
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
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
Positive impact!
Sustainable use of pesticidesDirective 2009/128/EC
National action plans
Integrated pest management by 2014
reduce the risk promote low risk techniques/pesticidespromote non-chemical methods
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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