Sub-group on Review of WFD Priority Substances Brussels, 26-27 January 2010

Agenda point 5: List of candidates substances for prioritisation and identification of the shortlist for preparations of dossiers Sub-group on Review of WFD Priority Substances Brussels, 26-27 January 2010 Jorge Rodriguez Romero WFD Team DG Environment, European Commission

Contents Recall of the process Overall prioritisation scheme Outcome of the Expert Group meeting Sept 2009 List of candidate substances Comments and proposals received for candidate substances Contents of the dossiers Identification of the shortlist of candidate substances for preparation of dossiers Methodology and criteria used Comments received on the approach Comments received on individual substances Distribution of dossiers among Member States and the Commission Next steps

Mandate of the Sub-Group on Review of WFD Priority Substances The Sub-group on Review (SG-R) is chaired by JRC and the United Kingdom and will be assisted by the Commission. SG-R is mandated to support the finalisation of the modelling-based prioritisation, to propose, based on their expertise and all available evidence and information, the candidate substances to be included on the priority substances list and to propose EQS for those in water, sediment and/or biota as appropriate. It is envisaged that Commission's consultants will continuously assist SG-R. The Commission will also request advice from the Sub-group on the revision of certain EQS or to develop EQS for sediment and/or biota for existing priority substances. The outcome of the work by the SG-R will be forwarded to the WG E. The activity of SG-R is planned until the Commission Proposal is finalised (expected by the end of 2010). As regards the work on control measures for existing and proposed priority substances, the Commission will propose the WG E the modalities for such work at a later stage and will seek endorsement of the SCG, if needed.

Overall approach to prioritisation

Outcome of September meeting (I) • Complete the list of candidate substances with the results of modelling • Application of the TRA tool to substances identified in modelling • Application of the delisting criteria for pesticides/biocides • Application of the representativeness criteria in INERIS report • Review of the RARs for the remaining substances to extract PEC and PNEC and possibly identify local risk only • Translation of the information of PEC and PNEC from RARs, monitoring and modelling to the candidate list • Identification of 30-50 substances by selecting the 10-15 first substances ranking highest from the various sources (RARs, monitoring and modelling) plus consideration of other sources (PBTs, SVHC, POPs, Annex III)

Outcome of September meeting (II) • Basic information on reliability of the various PEC and PNECs will be made available for the EG • After WG E in October there will be 6 weeks to propose additions to the list of candidate substances, by providing the agreed datasheet with the available information • Up to this point to be completed at the latest by the end of this year • Identification of leads for the preparation of dossiers for those 30-50 substances • In order to mobilise Member States resources for the preparation of dossiers, support to will be seek from WG and Water Directors • Next EG meeting January 2010 in Brussels

Actions agreed at the September meeting (see document 5.2a) 2 These figures have been taken from the conclusions of the Expert Group meeting in September. Actual number of substances may have varied due to correction of mistakes found in the list of candidate substances

Actions agreed at the September meeting (see document 5.2a)

A stepwise process for prioritisation Universe of chemicals ~2000 Application of simplified risk assessment procedures Assessment of existing risk evaluations List of candidates ~380 Application of prioritisation criteria Ranking exercise Shortlist ~30-50 Preparation of dossiers Discussion on individual substances Final outcome ~10-15 ?

List of candidate substances • General comments received from NL • Substance specific comments received from NL, CEFIC, Greenpeace and Plastics Europe • See document 5.1b

Comments to list of candidate substances (see document 5.1b) General comments and candidate substance specific comments Proposals to add additional substances to the candidate list

Contents of the dossiers Template agreed at the meeting in September The same as for the development of EQS but with some additional information (major uses and emissions) In a first phase the EQS need not to be developed and therefore some sections do not necessarily have to be filled in Only for those substances selected in the next step a full derivation of the EQS will be done (applying the TGD-EQS)

Sections of the dossier template Chemical identity Existing evaluations and regulatory information Proposed quality standards Major uses and environmental emissions Environmental behaviour Aquatic environmental concentrations Effects and quality standards Bibliography, sources and supportive information

Essential datafor a complete dossier so that this dossier can also be a strong basis for the derivation of EQS

Validity and sources of data • All data shall be quoted with exact and complete bibliographic reference, and the level of validation. • All data presented shall be validated: • at a European and/or international level (EU, OECD, US-EPA, etc.) OR • by the Stakeholderspresenting the data • Any new data not validated at a European/international level but deemed to be of good quality and usable for the derivation of the EQS shall be reported, underlined and quoted, including the acceptance by any national program associated to a Klimisch code (Klimisch et al., 1997) Klimisch, H. J., M. Andreae, et al. (1997). "A Systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data." Regulatory Toxicology and Pharmacology 25: 1-5.

Physico-chemical properties: • Solubility/Lipophility (KOW) [experimental/calculated – QSAR used, reference] • Adsorption capacity (KOC) [experimental/calculated – QSAR used, reference] • Bioaccumulation (BCF) [experimental/calculated – QSAR used, reference] • Biomagnification (BMF1, BMF2) [experimental / default value]

(Eco)toxicological datafor derivation of QSwater_eco • (If available) Ecotoxicological data necessary for derivation of a PNEC -> an EQS, i.e. • at least: • 1 acute ecotoxicity data on algae [ • 1 acute ecotoxicity data on invertebrates (crustaceans) • 1 acute ecotoxicity data on fish • If possible: • As many chronic data as possible [For all data, report : species, duration of the test, effect and no effect concentration, validation status, reference]

Toxicological datafor derivation of Quality standards for protection of human health • At least 1 NOAEL or NOEC for derivation of QSbiota_secpois • (If available) a toxicological reference value to evaluate the impact of the substance on mammalian species and the human, e.g.: • (Acute) Reference Dose ((A)RfD) • Tolerable/Acceptable Daily Intake (TDI/ADI) • Minimal Risk Level (MRL) The most secure data shall be underlined in order to be used for the derivation of the QSbiota_hh • Any (regulatory) standard for water intended for human consumption for derivation of QSdw_hh [For all data, report : species, duration of the test, dose, effect and no effect concentration, validation status, reference]

Approach to shortlist: five sources of prioritisation The monitoring-based prioritisation The modelling-based prioritisation The risk assessment reports from chemicals, pesticides and biocides legislation Consideration of other sources (PBTs, SVHC, POPs, Annex III) Proposals from Member States and stakeholders

1. The monitoring based prioritisation 41 substances ranking high or very high 20 substances candidate for deselection due to data quality and representativeness Deselected criteria confirmed in September: if there is no other prioritisation source these substances should not be investigated further This results in 14 substances out of the 20 that are not further considered for prioritisation (see below) Two PAHs ranked high are not further considered as PAH already included Additional 12 substances prioritised based on drinking water need alternative approach

2. The modelling based prioritisation The results of the modelling based prioritisation are ranked on the basis of the PEC/PNEC ratio

3. The risk assessment reports: ESR RARs screened to extract PEC and PNECs and with the following criteria: Default: select for further review as all of them have conclusion iii for aquatic environment. Only final RARs have been considered. If only a draft RAR is available then the substance is not considered further. If the risk assessment clearly indicates that the conclusion iii is reached for a local scenario or for only a few sites, and the scenario is not likely to be present in a significant number of river basins in the EU, the substance is not considered further. If the risk is labelled "local" but relates to widespread uses then it is deemed appropriate to identify the substance for further review. In case of doubt about whether the use is widespread or not the substance is kept for further review The assessment concludes with 12 substances selected for preparation of dossiers (see below) In addition, Copper and PFOS from voluntary risk assessments

3. The risk assessment reports: pesticides At the Expert Group meeting in September a proposal was discussed not to investigate further those pesticides that have been authorised but there is no other source of information for prioritisation The same approach has been applied to those pesticides that have been subject to a non-inclusion decision and do not rank high in any of the ranking exercises. It is proposed not to investigate further those pesticides. The risk assessments for the remaining 11 pesticides (see below) have been screened to extract the relevant information. The TERs have been used to rank the pesticides Methiocarb (104) and Deltamethrin (199) rank very high in the monitoring-based prioritisation but are proposed for de-selection by INERIS

3. The risk assessment reports: biocides The same criteria as for pesticides has been applied to the biocides, i.e. no further investigation is proposed if the substance is not ranked high in any of the ranking exercises and they are not identified as PBT, POP, SVHC or Annex III There is only one substance remaining after applying such criteria, Tolylfluanid (71), which is also authorised as pesticide

4. Consideration of other sources: PBTs PBT properties are taken into consideration in the modelling-based prioritisation. Out of the 13 PBTs/vPvB included on the list of candidate substances: 9 substances ranked high in the modelling based prioritisation, one of which ranked high as well in the monitoring based prioritisation 1 substance ranked high in the monitoring based prioritisation 3 other substances do not present any other source of prioritisation: Coal tar pitch, distillates, pyrene fraction (228): PAH is a priority substance Tetramethyllead (18): Lead and its compounds is a priority substance Nitrofen (99): pesticide banned in the EU since 1988 It is proposed not to investigate further these three substances. As a consequence, the PBT/vPvB properties does not add any additional substance for dossier preparation on top of those that have already been identified through modelling or monitoring

4. Consideration of other sources: SVHC A number of SVHC are already priority substances Others are covered in the list of candidate substances through parent compounds or groups of substances Two are not relevant to the aquatic environment The remaining 12 substances (see below) are selected as relevant

4. Consideration of other sources: POPs • It is proposed not to add any additional substance for dossier preparation on the sole basis of POP classification on top of those that have already been identified in the previous sections

4. Consideration of other sources: Annex III There are only a few Annex III substances that are not already proposed for further consideration due to other sources of prioritisation It is proposed to prepare dossiers for all Annex III substances

5. Proposals from Member States and stakeholders The following proposals have been received (see folder 5.1c): Germany proposes to consider PFOS for prioritisation and provides a data sheet and additional supporting information Sweden proposes to consider Irgarol for prioritisation and provides a data sheet The EEB sends proposals to consider pharmaceuticals and endocrine disruptors for prioritisation PFOS is already included in the shortlist The proposals from SE and EEB have been added to the list of candidate substances and potential inclusion in the shortlist is to be discussed

Final proposal of shortlist It is proposed not to investigate further the SVHC for which the reason to propose such classification is their CMR properties only, and there is no other source of prioritisation. This means it is proposed not to investigate further the following 7 substances: Acrylamide (21), Benzylbutylphthalate (BBP) (29), 4,4`-diaminodiphenylmethane (MDA) (41), 2,4-dinitrotoluene (51), Arsenic and its mineral compounds (117), Chromium and its compounds (119) and Cobalt and its compounds (120). The Coal tar pitch, distillates, pyrene fraction (228) need not be investigated further as PAH is already a priority substance. The same applies to Bis(tributyltin)oxide (TBTO) (4), as tributyltin compounds are already classified as priority substances. As regards other substances: Tetramethyllead (18) is no longer produced in the EU Nitrofen (99) is only used as an intermediate in the production of Aminofen (CAS 14861-17-7) by only one producer It is therefore proposed not to investigate further these two substances (Information extracted from the PBT assessment http://ecb.jrc.ec.europa.eu/esis/index.php?PGM=pbt)

Comments received (document 5.2d) Comments received from NL, FR, SE, IT, CEFIC, Eurometaux and ECPA General comments proposed for discussion: • Substance specific comments proposed for discussion:

Discussion General approach • Substance specific discussion: • Substances in the shortlist in document 5.2a • Proposals for additions to the shortlist • SE: Irgarol • EEB: endocrine disruptors and pharmaceuticals • NL: top ten pesticides

Sub-group on Review of WFD Priority Substances Brussels, 26-27 January 2010