State of Play Prioritisation of Substances By modelling Hazard & Exposure Klaus Daginnus

1. State of Play Prioritisation of Substances By modelling Hazard & Exposure Klaus Daginnus Institute for Health & Consumer Protection Joint Research Centre, European Commission S 6th WG E meeting Brussels July 6 http://ecb.jrc.ec.europa.eu/qsar/

2. Mandate by WG E to contribute to the revision of the Priority Substances List including the activities to improve the EU ranking scheme to develop a concept to select priority substances by modelling hazard and exposure and subsequent risk ranking based on UK / DG JRC methodology, presented at previous WG E meetings 4th meeting 14-15 May 2009 Participants (21) Member States: ES, FI, FR, NL, SE, SK, UK European Commission: DG ENV, DG JRC, DG ENT Stakeholders: Industry, EEB EG EQS subgroup on Priority setting

3. Steps and Actions Step completed; Action to be started N. of substances 1700 ~120 30-70 30 45 < 45

4. Proposed lists of substances INERIS report European Parliament Member States DK: substances classified as R50-53 SE SK: Joint Danube Survey 2 UK: EA report SC 040038/SR Stakeholders IARW European Environmental Bureau NORMAN Emerging Substances Inventories & substance data European Commission TCNES_PBT group EU Risk Assessment Reports DG ENV Endocrine disruptors priority list CAT1 & CAT2 ClassLab: substances hazardous to water (R50-53) EU Pesticides Database European Chemicals Agency List of pre-registered substances, processed by DG JRC US EPA DSSTOX EPISUITE FOOTPRINT Open for further data integration e.g. ECETOC Technical report 91, ECOTOX, Modelkey Starting list of Chemicals

5. Starting List of Substancessubstance types

6. Starting List of SubstancesHazard data availability

7. Action SCORING • Hazard scoring • Follows REACH Guidance, application of widely accepted tools to estimate hazard • Favors substances with PBT properties or substances of equivalent concern • Generation of a database with evaluated data, experimental data, predicted data • Priority scheme: evaluated data > experimental data > predicted data • Exposure Scoring • Use assessment by production volume & use category • Monitoring assessment (only for substances not covered by INERIS report) • Combined score use assessment / monitoring assessment • Request for data to ECHA, SPIN database (production volume & use category) • Proposed tool ECETOC Technical report No.93 • Risk Ranking • Combined hazard / risk score

8. Further Actions • Fugacity modelling • Tools OECD LTRP and / or ECETOC Technical report No.93 • Expert review • Refined risk assessment by uncertainty evaluation, optionally gather additional data • Risk ranking by PEC / PNEC • Optionally provisional PNECs derived from QSAR • Merging List • Determine overlap • Examine the reasons if substance lists do not overlap • Examine the reasons for different ranking positions of substances • Agreed merged List • Justifications for selected substances

9. Summary • Steps & actions have been proposed to generate the revised list of priority substances • Modelling exercise • is complementary to INERIS activity, relevant substances have been identified which are not part of regular monitoring programs of MS • follows REACH Guidance and makes use of REACH implementation projects • makes use of European and or international widely accepted hazard data and tools to predict data in case of data gaps • depends on the availability of data for exposure assessment • is risk based, favors the selection of PBTs or substances of equivalent concern and applies final ranking according to PEC/PNEC

10. ClassLab • DG ENV Endocrine disruptors priority list • DSSTOX • ECETOC • ECOTOX • EPISUITE • EU Pesticides Database • EU Risk Assessment Reports • FOOTPRINT • Joint Danube Survey 2 • Modelkey • OECD Pov and LRTP screening tool • SPIN database • TCNES_PBT group Thank you for your attention! Thanks to the subgroup for the successful meetings!