Groundwater Watch list «draft concept report» 32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta Groundwater Watch list «draft concept report» Rüdiger Wolter – Germany Ronald Kozel – Switzerland and group of volunteers: Benjamin Lopez – France (French Geological Service); Dennis Lemke – European Chemicals Commission; Volker Laabs and Dieter Schaefer - European Crop Protection Agency; Elisa Vargas Amelin - EU Commission; Emanuele Ferretti – Italy; Jacqueline Claessens – Netherlands ; Johannes Grath – Austria; Jonathan Smith - (CONCAWE); Ralph Eppinger – Flemish EA; Francis Delloye - Belgium, Wallonia; Rob Ward - UK BGS; Tim Besien - England EA; Wilko Verweij – Netherlands; Dan Lapworth – UK Malta (MT), 25-26 April 2017

32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta What has already been done: Watch list process launched by WG groundwater (Brussels) April 2015ü Meeting group of volunteers (Berne)  1st draft 8./9.9.2015ü Discussion at WG groundwater plenary (Luxemburg) 5./6.10.15ü Summary report for SCG and Approval 9./10.11.2015ü Discussion at WG groundwater plenary (Amersfoort) 11./12.04.2016ü Meeting group of volunteers (Vienna) 23./24.06.2016ü Meeting with NORMAN-working group (Paris) 27./28.06.2016ü Discussion at WG Groundwater plenary (Bratislava) 25./26.10.2016ü Tests of Column I, II and III procedure and adaptation Feb. 2017ü Meeting group of volunteers (Paris) 28.02.-01.03.2017ü Amendments and draft review April 2017ü

32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta What has to be done: Presentation and discussion (Malta) April 2017 Finalisation of GWWL methodology June 2017 Preparation of a second pilot study (PFCs) Mai 2017 Identification of organisation carrying out data collection June 2017 Start of first data collection 2018 Identification of first candidates for watch list end of 2018 Support to EC review of Annexes I and II of GWD 2019

32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta Group of Volunteers Meeting in Paris (28.02. - 01.03.2017) organised by Benjamin Lopez at BRGM Discussion based on version 8.3 of draft concept report Comments received from Ralf Eppinger, Francis Delloye, Kris von Den Belt and Christoph Leitner (COM) were integrated Further comments on version 8.3 have been received from Dieter Schaefer, Volker Laabs (European Crop Protection Association) and Dennis Lemke, (CEFIC) and discussed Comments received on version 8.5+ from Rob Ward (27/02/2017) Discussion focussed on Feedback to Draft 8.3 and 8.5+ of the Watch List Concept and Results of test runs of the ranking procedure (Monitoring – Leaching Potential – Hazard)

32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta Outcome Paris meeting: Proposed and agreed amendments New title: Groundwater Watch List (GWWL) - Concept and Methodology [old: Method to select substances for a Groundwater Watch List (GWWL) - Concept Paper -] Chapter 1.3 (Purpose and scope of this report): The sentence: “Proposing a procedure to determine substances which should be included in the candidate list and finally in Annex I or II of the GWD” was skipped. Chapter 2.2 (Purpose and scope of the GWWL): The sentence: “Create a candidate list for Annex I and II for the GWD” was skipped and replaced by “Provide information to support future European Commission review of Annexes I and II of the GWD”. Suggestion: New text on “What GWWL process is NOT” The Watch List should comprise only a limited number of substances or groups of substances.

Purpose of the watch list? 32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta Purpose of the watch list? (amended version) Identify new/emerging substances which have the potential to cause a failure of a WFD objective, based on new information; Assist MS in selecting substances to improve groundwater monitoring programs; Provide information to support future European Commission review of Annexes I and II of the GWD.

32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta The GWWL is not: (text integrated in version 9.3) A long list of substances that is generated by the substance prioritization process described in Chapter 3 (methodology), but rather a smaller subset (for example n=20) of compounds decided on through the prioritization process; A list of substances that will go automatically for consideration under Annex I and II. There will, by definition, be inadequate data for this on substances on the GWWL; A permanent list of substances. The GWWL will be reviewed periodically and substances can be deselected based on the prioritization process outlined in this paper; Meant as a ‘blacklist’ of substances which are of proven high concern for groundwater in the EU. The GWWL monitoring data will be available for use in a later and separate process for an EU-wide risk assessment.

32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta Further amendments Transparency of the process: the development of the process and the implementation of the process shall be transparent (which data are used, which criteria are applied, methodology behind ….) Quality requirements: in principle sufficiently covered in the draft, but more clarity in case there is lack of data e.g. for column II criteria like DT50, Koc, …. Proper use of terms like "harm", "risk", … etc. in the text The concept should comprise a deselection mechanism.  No need to define a de-selection process now. This will be done later once a watch list is operating and the volunteer group has more experience of how the process is working. Substances will be deleted from the list, when they are put in Annex I or II or when EC decides not to regulate a substance.

32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta Procedure after Paris meeting Circulation of revised version to the watch list drafting group - RK and RW integrate the amendments; input from drafting group members 15th March 2017ü Comments and feedback by drafting group 24th March 2017ü Updated Version 9.3 uploaded on CIRCABC 3rd April 2017ü Many thanks for their important support to: Benjamin Lopez, Dan Lapworth, Dennis Lemke, Volker Laabs, Dieter Schäfer, Johannes Grath

32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta Amended Process diagram according to discussion in Paris Groundwater Watch list process Prioritisation based on existing monitoring data (column I) Criteria: presence in GW Output: ranked list I Prioritisation based on exposure (column II) Criteria: theoretical groundwater leaching potential and extent of potential environmental exposure Output: ranked list II All substances Substances with groundwater leaching potential Prioritisation based on hazard (column III) Criteria: toxicological or ecotoxicological hazard Output: ranked list III All substances except Annex I or II substances List of substances having the proved and/or theoretical capacity to reach GW Groundwater Watch List GWWL List of substances posing a risk or potential risk to GW bodies List facilitating the Annex I + II process Base for revision of Annex I and II lists data available Sufficient monitoring Watch list monitoring

Column I Prioritisation based on existing monitoring data - Ranking procedure as presented in Bratislava Indicators Sub-score Score “Monitoring” A) Frequency of observations with concentrations > LOQ = value as a decimal number rounded to two decimals Value between 0 and 1 = (A + B + C) / 3 B) Number of countries with concentrations > LOQ 0 country = 0 1 countries = 0.10 >=2 countries = 0.20 >=5 countries = 0.50 >=10 countries = 1 C) Number of sites with concentrations > LOQ 0 site = 0 1 sites = 0.10 >=2 sites = 0.20 >=5 sites = 0.50 >=10 sites = 1 Score “Monitoring” = [(Score FQ) + (Score N°MS) + (Score N° Sites)] / 3

A) Frequency of observations with concentrations > LOQ 32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta A) Frequency of observations with concentrations > LOQ A) Frequency of observations with concentrations > LOQ A small number of sites analysed may lead to a high frequency For micropollutants the frequency of findings is generally very low Might be a misleading parameter because it is not known whether a substance is applied in the catchment of a sampling site. This parameter was skipped

Comparison of results of different ranking procedures Common Name Ranking ((A+B+C)/3) Score ((A+B*+C)/3) Score ((B*+C)/2) Score Carbamazepine 1 0,710 1,000 Sulfamethoxazole 3 0,517 2 0,617 0,900 Ibuprofen 5 0,507 4 0,540 0,800 Clofibric Acid 0,510 6 0,750 Diclofenac 0,504 7 Sulfadiazine 21 0,402 8 0,469 0,700 Clarithromycin 18 0,403 12 0,437 0,650 Fenofibric Acid 14 0,407 11 0,441 Paracetamol 0,482 0,515 9 Phenazon 0,409 10 0,443 Tramadol 0,427 0,460 Atenolol 22 0,600 Erythromycin 20 13 Gemfibrozil 24 0,401 Hydrochlorothiazide 15 17 iopamidol 0,408 16 Ketoprofen 23 Metformin 0,418 Metoprolol 25 19 Primidon 0,419 Propyphenazon Sotalol 0,406 Sulfadimidine Sulfamethazine 0,404 4-Formylaminoantipyrin 27 0,384 0,550 Bezafibrate 42 0,368 26

Column I: Amended ranking procedure Indicators Sub-score Monitoring score A) Number of countries with concentrations > LOQ (Score N°PC) (Values between 0 and 1) no country = 0.0 1 country = 0.2 2 countries = 0.4 3 countries = 0.6 4 countries = 0.8 5 or more countries = 1 [ (Score N°PC) + (Score N° sites)] / 2 Value between 0 and 1   B) Number of sites with concentrations > LOQ (Score N° sites) no site = 0.0 1 - 5 sites = 0.1 6 - 10 sites = 0.2 11 - 15 sites = 0.3 16 – 20 sites = 0.4 21 – 25 sites = 0.5 26 – 30 sites = 0.6 31 – 35 sites = 0.7 36 – 40 sites = 0.8 41 – 45 sites = 0.9 > 45 sites = 1.0 Monitoring score = [ (Score N°PC) + (Score N° sites)] / 2

32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta Ranking according to a theoretical groundwater leaching potential (Column II) Identifies the ability of a substance to reach groundwater based on the properties of that substance The mobility of a substance which is expressed by the solubility in water and the disability to be adsorbed to organic matter and (clay) minerals (the latter can be expressed by the logKOW (logP) or logD (grouping logKOW and log pKa)); and The persistence of the substance expressed by the half-life (DT50) depending on the physico-chemical conditions, as well as bioaccumulation and toxicity (PBT). + the amount of a substance released to the environment + ”type of exposure” (closed processes - e.g. with no intentional release to the environment - applied directly to the environment - i.e. air, soil and water)

32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta Column II: substances that have theoretically the potential to reach GW General procedure : Step1 “leaching potential” and Step2 “use pattern” Step: classical point system procedure

32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta Open question remains concerning the mobility assessment for polar and charged compounds First proposal: mention in the GW watch list concept paper the need for a specific approach for polar and charged compounds that could consist in a ranking based on the radicals of the molecules Agreement: we need a simple and comprehensive mobility assessment method for polar and charged compounds Proposed solution: approach should use the Soil Kd value, if available, to quantify sorption of polar and charged compounds To be furthermore discussed in the drafting group

32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta Column II: substances that have theoretically the potential to reach GW Step 2 of the column II: amount of a substance released to the environment how it gets to the groundwater table (pathways into the environment / to the groundwater table) Very important criteria for current assessment but Unlike chemical properties, it can evolve over time… (continuous activity) Criteria Indicators Cut off values and sub-score Score Use Use pattern Used in the environment = 1.0 𝑆𝑐𝑜𝑟𝑒 “𝑈𝑠𝑒” = [(“𝑈𝑠𝑒 𝑝𝑎𝑡𝑡𝑒𝑟𝑛” 𝑠𝑐𝑜𝑟𝑒) + (“𝑉𝑜𝑙𝑢𝑚𝑒” 𝑠𝑐𝑜𝑟𝑒)] 𝑛𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑓𝑖𝑙𝑙𝑒𝑑 “𝐼𝑛𝑑𝑖𝑐𝑎𝑡𝑜𝑟𝑠" Wide dispersive use (diffuse sources and substances in urban wastewater) = 0.6 Intermediate use only = 0.3 Production volume (REACH) Annual tonnage >1000t = 1.0 100 - 1000t = 0.75 10 - 100t = 0.5 0.1 – 10t = 0.25 < 0.1t = 0.0 Specific use indicators for Pharmaceuticals? (Annual EU tonnage not available)

Column III: hazard ranking Direct from NORMAN procedure - Valeria Dulio & Peter C. von der Ohe, NORMAN Prioritisation framework for emerging substances (2013) Indicators Value Sub-score Score “Hazard” PBT/vPvB Overall PBT/vPvB score = [(P + B + T) individual scores + (PBT/vPvB) score]/4 PBT: vP or P (1) + vB or B (1) + T+ or T (1) + vPvB or PBT (1) = 1 vPvBT+: vP or P (1) + vB or B (1) + T+ or T (1) + vPvB or PBT (1) = 1 vPvB: vP or P (1) + vB or B (1) + T+ or T (0) + vPvB or PBT (1) = 0.75 PB: vP or P (1) + vB or B (1) + T+ or T (0) + vPvB or PBT (0) = 0.5 PT+: vP or P (1) + vB or B (0) + T+ or T (1) + vPvB or PBT (0) = 0.5 Not PBT, not vPvB = 0 Value between 0 and 1 = [(PBT/vPvB) + (CMR) + ED)] / number of filled criteria CMR The CMR final score is derived as the highest value between the individual carcinogenicity, mutagenicity and reprotoxicity scores CMR, category 1 = 1 CMR, category 2 = 0.75 CMR, category 3 = 0.5 Under examination = 0.5 Examined and info not suff. = 0.25 Not examined = 0.25 Examined and not classified = 0 Endocrine Disrupting effects   Proven ED = 1 Suspected ED = 0.5 Not proven ED = 0 Score “Hazard” = [(“PBT / vPvB” score) + (“CMR” score) + (“ED” score)] / number of filled “criteria”

32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta Column III: Run test 1 – NORMAN scoring process Run test on Pharmaceuticals from the Pilot Study (285 individual names) Pharmaceuticals that have been scored regarding their potential hazard AND Pharmaceuticals ‘sufficiently monitored’ = analysed in 3 MS or more and quantified at least once => cut-off value to be elaborated 56 pharmaceuticals plotted (first 20 in diagram)

32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta To be discussed: In the frame of the watch list process, criteria have furthermore to be decided on the following questions: Following which procedure ranked lists I and II are used for column III Following which procedure substances have finally to be put into the Watch List based on ranked list III? Which of the substances should be put on the Watch List, but cannot be analysed due to missing or insufficient analytical techniques? What to do with these substances? Following which criteria substances should be put directly on the “List facilitating the Annex I and II process” (former “candidate list”) as sufficient data are already available? Definition of "sufficient monitoring data" has to be elaborated Which substances should not (yet) be put onto the Watch List? Who will do the work?? Which substances are so hazardous, that they should be regulated immediately without waiting until sufficient findings (contamination) of groundwater are identified (in Watch List Monitoring). How to avoid contamination by these substances – strengthen the prevent and limit approach)?

32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta Next steps after Malta Drafting group meeting in summer 2017 (open questions) Discuss the effect of the parameters “amount of substance” and “type of exposure” that are not jet integrated in Column II (assessment of leaching potential). Test of ranking procedure in Column I, II and III and global linkage Preparation of a second pilot study on PFCs. Emanuele Ferretti has provided a list of substances from the PFC group, including CAS codes. Based on that, RW developed a template for data collection for the 2nd pilot study. This template shall be complemented by a short questionnaire concerning monitoring information - e.g. whether background stations or "worst case" stations were selected, etc. The template and the questionnaire will be distributed to MS and PC MS and PC are asked to fill in the template and the questionnaire and send it back to RW. It has to be checked whether these data could be stored and managed under IPCHEM

32nd CIS Groundwater Working Group (WG GW) Plenary Meeting in Malta Thank you for your attention !

(B) Number of countries with concentrations > LOQ It should be sufficient if a substance is found in 5 or more countries to get the maximum value.

(C) Number of sites with concentrations > LOQ The number of sites should be greater than 45 to get the maximum value of 1.00