water.europa.eu Policy update with regard to Priority and Emerging Substances SOCOPSE Final Conference Maastricht, June 2009 Jorge Rodriguez Romero WFD Team Coordinator DG Environment, European Commission

Socopse Final Conference, Contents Priority substances: state of play Priority substances vs emerging substances Working with other related legislation (REACH, pesticides, biocides, …) Outlook

Socopse Final Conference, Legal framework Article 16 of WFD Article 8 of Directive 2008/105/EC (EQSD) Within the framework of the review of Annex X to Directive 2000/60/EC, as provided for in Article 16(4) of that Directive, the Commission shall consider inter alia the substances set out in Annex III to this Directive for possible identification as priority substances or priority hazardous substances. The Commission shall report the outcome of its review to the European Parliament and to the Council by 13 January It shall accompany the report, if appropriate, with relevant proposals, in particular proposals to identify new priority substances or priority hazardous substances or to identify certain priority substances as priority hazardous substances and to set corresponding EQS for surface water, sediment or biota, as appropriate.

Socopse Final Conference, Prioritisation principles Significant risk to or via aquatic environment, including to surface waters used for drinking water Identification of risks through 1.Risk assessments under chemicals, pesticides or biocides legislation 2.Targeted risk assessment focusing only on toxicity to or via aquatic environment 3.Simplified risk-based assessment procedure based on scientific principles and taking into account intrinsic hazard monitoring data production volumes and/or use patterns.

Socopse Final Conference, Tier 1: risk assessments under chemicals, pesticides, biocides 97 finalised risk assessment reports under Existing Substances Regulation 793/93 (+24 drafts) 334 pesticides active substances in Annex I Directive 91/414/EEC 14 substances included in Annex I of Directive 98/8/EC on biocides Subsidiarity: Priority substances should be an EU wide problem, otherwise should be regulated at national/RBD level (as part of ecological status)

Socopse Final Conference, Tier 3: Simplified risk assessment 2001 priority list: COMMPS (Combined Monitoring-based and Modelling-based Priority Setting) New data collection COMMPS 1999 Monitoring risk ratio-based approach 2009 Nb Countries15 + Eureau28 + Vewin A priori non candidate substances Al, Br, Fe, NH3, Cyanides, DDT, phenols, etc. No Nb candidate substances 314 (water) 221 (sediment) Nb substances (manageable list) 95 (water) 60 (sediment) 317 Nb water analysis Nb sediment analysis Nb biota analysis

Socopse Final Conference, Tier 3: Simplified risk assessment Monitoring- based ranking Modelling- based ranking Establishment of the manageable list Establishment of the universe of chemicals Central database data collection preparation and treatment Assessment of exposure and hazard Scoring Application of fugacity modelling 1 st Expert review (de-selection criteria) List of substances  Consideration of risk ratio and other criteria 2 nd Expert review (de-selection criteria) Evaluation of exposure and effects data Application of prioritisation algorithm List of substances  1 st Expert review (de-selection criteria) Final list of substances Monitoring data provide an excellent basis, from direct observation, to get information on European environmental conditions. However, monitoring data cannot be used as the single scoring method because the available information is incomplete and only covers a set of substances which were considered "relevant" in the past. Thus, the current monitoring information is biased by previous decisions on which substances should be monitored. (…) Therefore, it is important to incorporate a second system, to allow inclusion in the final list, of substances with a high potential risk for aquatic organisms for which no monitoring information is available to date. Opinion of CSTEE on COMMPS

Socopse Final Conference, Additional substances of concern Directive 2008/105/EC Annex III substances (13) Existing substances regulation PBTs (27) REACH Substances of Very High Concern SVHC (16) ECHA recommended recently 7 of them for authorisation Persistent Organic Pollutants POPs Others: OSPAR priority, pharmaceuticals, etc

Socopse Final Conference, Historical pollutants PCBs, dioxins Heavily regulated since years Still causing problems due to PBT properties There are arguments in favour of listing them as priority substances Trigger for action From a regulatory point of view, the reason for including these chemicals in the list is the need for assessing the effectiveness of existing measures and the evolution of water quality as a consequence of the measures. (CSTEE 1999)

Socopse Final Conference, EQS setting EQS Technical Guidance in final draft stage Testing period over next months To be finalised by the end of 2009 Water – sediment – biota

Socopse Final Conference, Priority vs emerging substances Not monitored Not regulated WFD article 16: significant risk to or via aquatic environment There is no place for emerging pollutants if risk is not demonstrated – e.g. presence is not enough RESEARCH (e.g. NORMAN network, Modelkey) REACH

Socopse Final Conference, Scarcity of monitoring data Analysed Fraction   Analysis   Fish - Fish Liver15 Mussel - Mussel Whole9 Sediment - Fraction <2mm (whole)62 Water - Whole water with no separation of liquid and SPM phases 42 Example: PFOS Annex III Directive 2008/105/EC

Socopse Final Conference, Quality of monitoring data Example: Triphenyltin compounds MatrixFraction Nb of total analysis Analysis for which LOD>2*PNEC NbPercentage WaterWhole water ,8% Number of analysis with both LoD and LoQ611

Socopse Final Conference, Control measures WFD Article 16(6) Commission proposal in 2006: existing measures at Community level should be sufficient to achieve the objectives – this needs to be looked at Revision of river basin management plans: pressures – status – measures Activity on emissions under WG E Priority Substances Research projects (like SOCOPSE)

Socopse Final Conference, Working with other legislation REACH Registration dossiers Annex XV dossiers (SVHC) Evaluations Pesticides & biocides Authorisations for use WFD as downstream safety net to ensure measures taken to mitigate the risk are efficient – and providing a feedback mechanism to those other policies in case further product controls are needed

Socopse Final Conference, Outlook Overall methodology for WFD article 16 Community action to be consolidated, to be used in future updates, including relationship with other legislation Progressively evolving in the future Improve information base Chemical monitoring in Member States (Commission Directive on QA/QC to be adopted in July 2009) REACH (ecotoxicological data, use patterns) Effectiveness of measures: RBMP cycle Emerging substances Research (Socopse, ScorePP, Modelkey, Neptune, …)

Socopse Final Conference, Thank you for your attention water.europa.eu