Overview of EFSA’s work on opinions and guidance Luc Mohimont Pesticides Unit Crop Protection European Regulatory Conference, March 2015

Content of the presentation Environmental risk assessment 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

Aquatic ecotoxicology EFSA today 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

Terrestrial ecotoxicology EFSA today 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).

Terrestrial ecotoxicology EFSA today 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)

Terrestrial ecotoxicology Bees EFSA today 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

EFSA today 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

EFSA today 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

EFSA today 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

EFSA today 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

EFSA today 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 Outsourced compilation of database on genotoxicity end points Possible training activities to MSs

EFSA today 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

Cumulative Risk Assessment: Implementation EFSA today 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

Cumulative Risk Assessment: Implementation EFSA today 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

Possible future mandates EFSA today 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

Thank you for your attention EFSA today Thank you for your attention