Transcript Slide 1

Overview of EFSA’s
work on opinions
and guidance
Luc Mohimont
Pesticides Unit
Crop Protection European Regulatory
Conference, March 2015
EFSA today
Content of the presentation
 Environmental risk assessment

Aquatic ecotoxicology

Terrestrial ecotoxicology

Fate and behavior
 Human risk assessment

Epidemiology

Residue definition for risk assessment

Dermal absorption

Cumulative risk assessment
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ENVIRONMENTAL RISK ASSESSMENT
Aquatic ecotoxicology
 Guidance on tiered risk assessment for aquatic organisms
in edge-of-field surface waters adopted in 2013 and noted
by the PAFF
 Opinion on the effect assessment for pesticides on
sediment organisms in edge-of-field surface waters to be
adopted by December 2015
 Opinion on the state of mechanistic effect modelling
approaches for regulatory risk assessment of pesticides for
aquatic organisms to be adopted by December 2017
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ENVIRONMENTAL RISK ASSESSMENT
Terrestrial ecotoxicology
 2 Opinions adopted in 2014 on the state of science
regarding the risk assessment of non target terrestrial
plant and non target arthropods
 2 Opinions to be prepared on the state of science
regarding the risk assessment of in-soil organisms
(December 2015) and amphibians and reptiles
(September 2016)
 Consultation of Risk Managers on Specific Protection Goals
(Starting 2015)
 Preparation of sectorial EFSA guidance documents in each
of the 4 areas (Within 2 years after agreement of the
respective SPGs).
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ENVIRONMENTAL RISK ASSESSMENT
Terrestrial ecotoxicology
Public Consultations:
 In-soil organisms opinion (4th quarter 2015)
 Amphibians and reptiles opinion (4th quarter 2015)
 4 draft sectorial EFSA guidance documents (2017-2018)
Workshop:
 Topical ECHA scientific workshop on soil risk assessment to
be held in Helsinki in cooperation with EFSA (October
2015)
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ENVIRONMENTAL RISK ASSESSMENT
Terrestrial ecotoxicology
Bees
 EFSA guidance on the risk assessment on bees (Apis
mellifera, Bombus spp. and solitary bees): Approved in
2013, updated and complemented with a calculator tool in
2014, but so far not noted by the PAFF
 Statement to be delivered by the PPR Panel by June 2015
on the suitability of the BEEHAVE model for a potential use
in the context of the Regulation (EC) No 1107/2009
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ENVIRONMENTAL RISK ASSESSMENT
Fate and behavior
 EFSA guidance on the emissions from protected crops
approved in 2014 and noted by the PAFF
 EFSA guidance on the evaluation of laboratory and field
dissipation studies to obtain soil DegT50 values approved
in 2014 and noted by the PAFF
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ENVIRONMENTAL RISK ASSESSMENT
Fate and behavior
 EFSA guidance for predicting environmental concentrations
in soil:
 Approval in June 2015 for annual crops
 Approval in 2017 for permanent crops and crops
grown on ridges, including public consultation
 PERSAM software tool supporting the derivation of
PECs for spray applications on annual crops for
conventional and reduced tillage available on the
JRC website
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Human Risk Assessment
Epidemiology
 External Scientific report on systematic reviews of
epidemiological studies linking pesticide exposure to
human health outcome carried out by the University of
Ioannina Medical School in Greece (2013)
 Stakeholder workshop on pesticide epidemiology, Paris,
February 2015
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Human Risk Assessment
Epidemiology
 Opinion of the PPR Panel investigating experimental
toxicological properties of plant protection products having
a potential link to Parkinson’s disease and childhood
leukaemia (by June 2016)
 Opinion of the PPR Panel on the follow-up of the findings of
the External Scientific report ‘Literature review on
epidemiological studies linking exposure to pesticides and
health effects’ (By march 2017)
 Public consultations on the 2 draft opinions
 Scientific conference end 2017
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Human Risk Assessment
Pesticide residues
 Guidance of the PPR Panel on the establishment of the
residue definition for dietary risk assessment (to be
adopted by December 2015)

Public consultation in summer 2015
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Outsourced compilation of database on genotoxicity
end points
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Possible training activities to MSs
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Human Risk Assessment
Dermal absorption
 EU Commission request to assess new studies on dermal
absorption and, if appropriate, to revise the guidance
document on dermal absorption
 Data collected by industry and public institutions
(BfR)
 EFSA scientific report on the quality assessment of
the data and compilation of a comprehensive data
set by February 2016
 Preparation of a new (EFSA) guidance on dermal
absorption by May 2017, including public
consultation
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Human Risk Assessment
Cumulative Risk Assessment: Implementation
 2015-2016: Framework Partnership Agreement between
EFSA and RIVM covering several specific actions:

Improvement of the MCRA tool (scalability to large
CAGs…)

Cumulative Exposure Assessments with MCRA for 2
acute effects on the nervous system and 2 chronic
effects on the thyroid system. Scientific reports by
mid 2016
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Human Risk Assessment
Cumulative Risk Assessment: Implementation
 EFSA internal programme

2015-2016: Cumulative Exposure Assessments with
SAS for 2 acute effects on the nervous system and
2 chronic effects on the thyroid system. Scientific
Reports by mid 2016

2017: EFSA Scientific Reports on the Cumulative
Risk Assessment for the effects on the nervous
system and the thyroid

2016-2018: EFSA Scientific Reports on CAGs for
specific effects on the nervous system, the liver, the
eyes, the adrenals, the reproduction and the
development
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Future Mandates
Expected Mandates
 Review of the Birds and Mammals GD
 RA of isomers
 FOCUS SW repair action
Possible future mandates
 Microorganisms
 MedRice
 Toxicological reference values for non dietary exposure
 Cumulative Risk Assessment for non dietary exposure
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Thank you for your attention