francesca arena european commission health and consumers directorate general future data...

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