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

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Presentation on theme: "Overview of EFSA’s work on opinions and guidance Luc Mohimont Pesticides Unit Crop Protection European Regulatory Conference, March 2015."— Presentation transcript:

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

2 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 EFSA today

3 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 EFSA today ENVIRONMENTAL RISK ASSESSMENT

4 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). EFSA today ENVIRONMENTAL RISK ASSESSMENT

5 Terrestrial ecotoxicology Public Consultations:  In-soil organisms opinion (4 th quarter 2015)  Amphibians and reptiles opinion (4 th 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) EFSA today ENVIRONMENTAL RISK ASSESSMENT

6 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

7 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

8 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 ENVIRONMENTAL RISK ASSESSMENT

9 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

10 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

11 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

12 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 EFSA today Human Risk Assessment

13 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 EFSA today Human Risk Assessment

14 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 EFSA today Human Risk Assessment

15 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 EFSA today Future Mandates

16 Thank you for your attention EFSA today


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