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
Outline
Legislation on plant protection products
Data requirements
Current and future
Risk assessment
Criteria approval/uniform principles
Plant Protection Products
EU legislation
Directive
91/414/EEC
Directive
Regulation
91/414/EEC
1107/2009
from 14 June 2011
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
DIRECTIVE 91/414/EEC
Harmonised data
requirements
Harmonised
Uniform principles
Active substances
Plant protection products
Plant protection products
EU Approval of active substances
Applicant
MS/ EFSA
Dossier on an active
substance
Evaluation
BASED on data
requirements
Risk assessment
scheme
Commission
Decision
Criteria for
approval
National authorisation of PPP
Applicant
Dossier on PPP
BASED on data
requirements
Member
State
Evaluation
Risk assessment
scheme
Member
State
Decision
Uniform
principles
Harmonised data requirements
Developed between 1993 and 1996
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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
Revision started under
Dir 91/414/EEC, but….
Directive
91/414/EEC
Regulation
1107/2009
Transfer of current data requirements
by 14 June 2011
New data requirements
Vote
new data req.
June
2011
July
2011
Publication
Application
December
2011
January
2012
20132014
Regulation
1107/2009
applicable
Old data requirements applicable
Honeybees
Current data requirements
Active substances
Acute toxicity test
(laboratory)
Bee brood (honeybee larvae) (lab/semi-field)
Plant protection products
Acute toxicity test
Residue test
Cage/tunnel test
Field test
(laboratory)
(laboratory)
(semi-field)
(field)
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
Honeybees
Shortcomings
Testing protocols to be improved!
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
Honeybees
Shortcomings
Exposure scenarios
Risk from drift of dust
Expression of pesticides in nectar and
pollen, water, plant guttation and
accumulation
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
Cage/tunnel test
Field test
(laboratory)
(semi-field)
(field)
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
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
New data requirements
More flexible structure
Regulation (data requirements)
Communication (test guidelines)
updated more frequently
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
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
Regulation (EC) No 1107/2009
New approval criteria
Honeybees
No unacceptable acute or chronic effects on
colony survival and development, taking into
account affects on honeybee larvae and honeybee
behaviour
Directive 2009/128/EC
Sustainable use of pesticides
Positive impact!
National action plans
reduce the risk
promote low risk techniques/pesticides
promote non-chemical methods
Integrated pest management by 2014
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