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

2. 2 EG EQS subgroup on Priority setting 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 4 th 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

3. 3 Steps and Actions 30.06.2009 Starting list of chemicals; Scoring 31.08.2009 List with high scores (1-2); Fugacity modelling 15.09.2009 List with water relevance; expert consultation and refined risk assessment 15.10.2009 PEC/PNEC ranked list modelling exercise, merge lists 15.11.2009 Merged lists (monitoring /modelling); expert consultation 15.12.2009 Agreed merged ranked lists 1700 ~120 30-70 30 45 < 45 N. of substancesStep completed; Action to be started

4. 4 Starting list of Chemicals 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

5. 5 Starting List of Substances substance types

6. 6 Starting List of Substances Hazard data availability

7. 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. 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. 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. 10 –ClassLabClassLab –DG ENV Endocrine disruptors priority listDG ENV Endocrine disruptors priority list –DSSTOXDSSTOX –ECETOCECETOC –ECOTOXECOTOX –EPISUITEEPISUITE –EU Pesticides DatabaseEU Pesticides Database –EU Risk Assessment ReportsEU Risk Assessment Reports –FOOTPRINTFOOTPRINT –Joint Danube Survey 2Joint Danube Survey 2 –ModelkeyModelkey –OECD Pov and LRTP screening toolOECD Pov and LRTP screening tool –SPIN databaseSPIN database –TCNES_PBT groupTCNES_PBT group