WG-E(1) Meeting, CCAB, Brussels, 06/03/2007 Agenda Item 7: Review of the list of priority substances (Decision 2455/2001/EC) WG-E(1)-07/02/INERIS Prioritisation of substances: final draft document and open issues WG-E(1) Meeting, CCAB, Brussels, 06/03/2007

What’s new ? Compilation of comments received after EAF(9) Including post EAF(8) comments from UK Background document (i.e. methodological principles) updated and amended according to UK comments (version 3) Towards a tiered assessment methodology: amended according to post EAF(9) comments (version 2) Indicative lists of candidate substances: updated (version 2) Open issues

What’s old ? Choose relevant parameters Data collection & processing WFD priority substances yes Data collection & processing EU relevance? ? Further investigation Choose candidate substances Priority setting no Substances of national concern ...but, unmanageable list of candidate substances

What’s next ? Choose relevant parameters Data collection & processing WFD priority substances Data collection & processing EU relevance? Political arbitration Further investigation Choose candidate substances Priority setting Substances of national concern Please don’t forget emerging pollutants!

Compilation and analysis of MS questionnaires Choose candidate substances Compilation and analysis of MS questionnaires Candidate substances will necessarily be selected from relevant substances identified by MS

Compilation and analysis of MS questionnaires Choose candidate substances Compilation and analysis of MS questionnaires Candidate substances will necessarily be selected from relevant substances identified by MS

Choose relevant parameters Monitoring data in water Monitoring data in sediment Monitoring data in biota Ecotoxicity for aquatic organisms Ecotoxicity for benthic organisms Oral toxicity for mammals/birds Toxicity for humans Kow, vapour pressure, persistence, bioaccumulation Additional data for modelling (production, sales, releases, etc.) CAS number PEC in water (monitoring) PEC in sediment (monitoring) PEC in biota (monitoring) PNEC for aquatic organisms PNEC for benthic PNEC for secondary poisoning of predators Maximum allowed residues in food Drinking water criteria Water Solubility log Kow Vapour pressure Biodegradability Hydrolysis Production Releases PEC (modelling) Representativeness Endocrine Disruption

Choose relevant parameters: open issues Monitoring data in water Monitoring data in sediment Monitoring data in biota Ecotoxicity for aquatic organisms Ecotoxicity for benthic organisms Oral toxicity for mammals/birds Toxicity for humans Kow, vapour pressure, persistence, bioaccumulation Additional data for modelling (production, sales, releases, etc.) CAS number PEC in water (monitoring) PEC in sediment (monitoring) PEC in biota (monitoring) PNEC for aquatic organisms PNEC for benthic PNEC for secondary poisoning of predators Maximum allowed residues in food Drinking water criteria Water Solubility log Kow Vapour pressure Biodegradability Hydrolysis Production Releases PEC (modelling) Representativeness Endocrine Disruption

Choose relevant parameters: open issues Monitoring data in water Monitoring data in sediment Monitoring data in biota Ecotoxicity for aquatic organisms Ecotoxicity for benthic organisms Oral toxicity for mammals/birds Toxicity for humans Kow, vapour pressure, persistence, bioaccumulation Additional data for modelling (production, sales, releases, etc.) Maximum residue levels in foodstuffs Carcinogenicity? Risk via groundwater? Inhalation & dermal contact? R-phrases from C&L? CAS number PEC in water (monitoring) PEC in sediment (monitoring) PEC in biota (monitoring) PNEC for aquatic organisms PNEC for benthic PNEC for secondary poisoning of predators Maximum allowed residues in food Drinking water criteria Water Solubility log Kow Vapour pressure Biodegradability Hydrolysis Production Releases PEC (modelling) Representativeness Endocrine Disruption

MS monitoring data will be collected via the End User Tool Data collection: monitoring data WISE MS monitoring data will be collected via the End User Tool The COM will consider all data submitted from now to 25 May 2007 Feedback expected until 16 March 2007

Different data sources: Data collection: other data Targeted data collection for chemical/physical properties, ecotox, etc. From mid 2007 to end of 2007? Different data sources: Completed risk assessments (Tier 1 assessment) under Reg. (EEC) 793/93, Dir. 91/414/EEC, Dir. 98/8/EC (WFD Art. 16(2)a) Targeted risk assessments (Tier 2 assessment) focusing on aquatic ecotoxicity and on human toxicity via the aquatic environment (ongoing RA, RA under Dir. 93/67/EEC, VRA) (WFD Art. 16(2)b,1st §) Simplified risk assessments (Tier 3 assessment). (WFD Art. 16(2)b,2nd §) Scientific litterature, databases, etc.

Different data sources: Data collection: other data Targeted data collection for chemical/physical properties, ecotox, etc. From mid 2007 to end of 2007? Different data sources: Completed risk assessments (Tier 1 assessment) under Reg. (EEC) 793/93, Dir. 91/414/EEC, Dir. 98/8/EC (WFD Art. 16(2)a) Targeted risk assessments (Tier 2 assessment) focusing on aquatic ecotoxicity and on human toxicity via the aquatic environment (ongoing RA, RA under Dir. 93/67/EEC, VRA) (WFD Art. 16(2)b,1st §) Simplified risk assessments (Tier 3 assessment). (WFD Art. 16(2)b,2nd §) Scientific litterature, databases, etc.

Data processing Choose relevant metadata (see document for data collection) Discard data of demonstrated low quality: simplified quality check see revised background document Discard data of low plausibility (statistical outliers) according to COMMPS Aggregate data 1 data per substance × parameter according to COMMPS

Data processing Choose relevant metadata (see document for data collection) Discard data of demonstrated low quality: simplified quality check see revised background document Discard data of low plausibility (statistical outliers) according to COMMPS Aggregate data 1 data per substance × parameter according to COMMPS

It is recommended to test different algorithms Priority setting Other? Inorganics? Risk scores? Risk ratios? It is recommended to test different algorithms Should be done for 2008

Political arbitration At last*, but not least WFD priority substances Political arbitration Further investigation Substances of national concern Fix potentially remaining outstanding issues Fix criteria for EU relevance Fix the number of substances to be included in the priority list * after 2007

Feedback on the End User Tool MS Questionnaires Candidate substances Jan 07 Pilot study (UK, IE, SI, SE) Feedback on the End User Tool 16 Feb 2007 Feb 07 16 Mar 2007 Mar 07 WG E (6th March 2007) 1st data collection (Monitoring data only) Apr 07 - fix outstanding technical questions - discuss first results from the questionnaire May 07 25 May 2007 Jun 07 Expert consultation Jul 07 - Select substances for a targeted data collection Aug 07 Sep 07 2nd data collection (supp. Monitoring data, chemical/physical properties, ecotox, etc.) Oct 07 Nov 07 Dec 07 - Apply the prioritisation algorithm Priority setting 2008 - Fix potentially remaining outstanding issues - Fix criteria for EU relevance - Fix the number of substances to be included in the priority list Political arbitration Substances of national concern WFD priority substances Further investigation