Proposed Substance Assessments

1. Proposed Substance Assessments Working Group E meeting 27th January 2011

2. Pesticides/biocides • Pharmaceuticals • Industrial chemicals • Existing substances will be discussed tomorrow

3. Aclonifen • Basis of assessment • Herbicide used on sunflowers, maize, beans, peas, authorised in 19 MS. Applied pre-emergence • Case studies France (majority of use) and Sweden (questionnaire response indicated slightly different authorised uses, i.e. including forest nurseries) • Data used includes: information from MS, questionnaire responses, Draft Assessment Report, available monitoring data • Impacts if PS (including proposed EQS) • Data indicates relatively few failures, but EQS=MAC, so any failures of EQS also equal MAC failure. DAR also indicates potential for failure, even with buffer zones • Therefore some local measures may be required, although data did not allow these to be reliably identified or costed • Additional impacts if PHS • Unlikely to be possible to guarantee complete cessation of emissions as long as use continues. Cessation of use and production could in theory be required • Uncertainties • Extent to which existing measures will affect monitored concentrations (e.g. directive on sustainable use of pesticides, and pesticide reduction strategies in France) • Relationship between timing of pesticide application and timing and location of monitoring

4. Bifenox • Basis of assessment • Herbicide used predominantly on winter cereal crops. Applied post-emergence • Case studies France (majority of use) and UK (questionnaire response indicated slightly different authorised uses, i.e. including amenity grassland) • Data used includes: information from MS, questionnaire responses, Draft Assessment Report, available monitoring data • Impacts if PS (including proposed EQS) • Data indicates few failures of individual monitoring points. DAR indicates potential for failure in worst- case • Unlikely that much action will be required- possibility of some local measures being required, following enhanced monitoring. (insufficient data to allow these to be reliably identified or costed now) • Uncertainties • Extent to which existing measures will affect monitored concentrations (e.g. directive on sustainable use of pesticides, and pesticide reduction strategies in France) • Relationship between timing of pesticide application and timing and location of monitoring

5. Quinoxyfen • Basis of assessment • Fungicide used on grapes and cereal crops. Authorised in 17 MS. • Case studies France (monitoring data suggest historic problems, although FR do not consider current problem) and UK (questionnaire response indicated potential problem) • Data used includes: information from MS, questionnaire responses, available monitoring data, field trials • Impacts if PS (including proposed EQS) • Data indicates very few failures. 5m buffers in FR and UK assumed to apply elsewhere, but potential for increased risk if not. Supported by field trials • More widespread monitoring required, which may identify need for some local measures. Data did not allow these to be reliably identified or costed • Additional impacts if PHS • Unlikely to be possible to guarantee complete cessation of emissions as long as use continues. Cessation of use and production could in theory be required • Uncertainties • Relationship between timing of pesticide application and timing and location of monitoring

6. Dichlorvos • Basis of assessment • Organophosphate insecticide. Previous agricultural pesticide uses no longer authorised. Also previously used in salmon farming. Now limited indoor uses, including agri and household • Case studies France (majority of data), Italy (questionnaire response indicated relatively high use), Latvia (questionnaire response indicated use) • Data used includes: information from MS, questionnaire responses, Draft Assessment Report, available monitoring data • Impacts if PS (including proposed EQS) • Although historic data show failures of EQS, seems reasonable to assume these are from historic use and may not occur in future. Further monitoring required, but currently few measures envisaged • Additional impacts if PHS • Although use does not provide obvious pathways to water, risk from production/ formulation, spills etc remain. May be considered unrealistic to guarantee complete cessation of emissions as long as use continues. Cessation of use and production could in theory be required. Given existing measures and apparent lack of pathway, benefits may be minor • Uncertainties • Possible that some types of use are not fully known/understood • Proposed EQS lower than LOD- difficulties assessing compliance • Difficulties interpreting historic monitoring data in light of current uses

7. Cybutryne • Basis of assessment • Antifoulant used on boats (recreational and commercial). Use banned on small boats in some MS (DK, UK). Also some use as preservative/antifoulant on buildings (Irgaguard) • Case studies UK, Denmark and Germany (available monitoring data; coastal MS) • Data used includes: information from MS, questionnaire responses, available monitoring data • Impacts if PS (including proposed EQS) • Failures have been recorded- mostly salt water, although SE note potential high level of failures in lakes. • Expected that use of cybutryne would need to cease in those areas to be effective measure. Alternatives may be available (e.g. as used in UK, DK?) but possible costs to users (higher cost of alternative, or higher fuel costs if less effective) • Extent and impact of measures (and hence costs) not calculated due to insufficient data- some data may be out of date (e.g. before national bans) • Assessment has not assumed mechanism by which cessation of use enforced. However if ban on use, risk that boats could be painted outside area of enforcement and still bring cybutryne in to areas at risk • Uncertainties • Little known about extent of use of Irgaguard and likely contribution to EQS failures. • Further information about alternatives and their costs needed • Effectiveness of EU-only measures (ban)

8. Cypermethrin • Basis of assessment • Authorised pesticide and biocide. Most studied use is for sheep dip, particularly in UK (no longer used for this purpose in UK). Biocidal uses also in salmon farming • Authorised as agricultural pesticide in 25 MS, including forestry • Case studies UK (predominance of investigations), Sweden (identified use other than on crops) and Italy (identified use on orchards as opposed to cereal crops) • Data used includes: information from MS, questionnaire responses, available monitoring data • Impacts if PS (including proposed EQS) • Studies in UK show high potential for exceeding EQS when used as sheep dip, possibly even with measures in place. However no longer used in UK- risk may remain elsewhere in EU. More stringent measures or cessation of use of cypermethrin may be necessary • Where wool treated with cypermethrin is used in textiles, treatment may be required at factories or downstream treatment works. However need for treatment may decline over time if cypermethrin use on sheep decreases • Costs to salmon farming in UK, IE associated with use of alternatives, although use of cypermethrin declining in baseline. • Almost no failures of EQS in available monitoring data outside UK- little evidence to suggest impact from agriculture or forestry so no measures proposed • Uncertainties • Limited information regarding use of cypermethrin for sheep dip outside UK and Ireland • Limited assessment of pesticide use on crops/forestry, due to focus of previous studies on sheep dip. Possible gap in historic data collection • Extent to which use of cypermethrin likely to continue in salmon farming

9. Terbutryn • Basis of assessment • Previous use as herbicide, but not authorised on 91/414/EEC. Ongoing use as algicide on buildings • Case studies UK and Germany (predicted or possible failure of EQS) and Latvia (reported ongoing use/formulation) • Data used includes: information from MS, questionnaire responses, available monitoring data • Impacts if PS (including proposed EQS) • Failures reported but expected to be predominantly from herbicide use. Difficult to predict level of ongoing failure from existing uses until more monitoring undertaken- one study in DE suggests ongoing detection • Where required, SuDS most likely measure, to capture runoff from buildings at/close to source. Majority of SuDS may be baseline at least in some MS • Use of alternative may be an option but has not been assessed • Uncertainties • Further information about alternatives would be beneficial • Monitoring data after cessation of use as herbicide

10. Heptachlor • Basis of assessment • Organochlorine insecticide, not used in EU since 1984. • POP • Case studies Czech Republic, Portugal, Belgium (monitoring data suggested failures of EQS)- although discussion predominantly EU level • Data used includes: information from MS, questionnaire responses, available monitoring data, Stockholm Convention NIPs • Impacts if PS (including proposed EQS) • Data indicates failures in some MS, although considerable uncertainty since LOD > EQS (even for biota). Concentrations will continue to reduce over time • If heptachlor likely to still be detected over EQS/PHS timescales, measures may need to be considered. Remediation of contaminated land, or, if detected, removal of heptachlor from wastewater • Resulting costs to water industry, public bodies and, if identifiable, historic polluters. Unlikely to be common and number of measures cannot be predicted • Additional impacts if PHS • Measures and impacts expected to be similar as for PS • Uncertainties • Trends in monitoring data required rather than lumped average, to improve understanding reductions over time • Disproportionate cost? Extent to which MS would be likely or able to implement measures • Ability to achieve required analysis standards (in water and/or biota)

11. Dicofol • Basis of assessment • Pesticide previously used on fruits (especially lemons, oranges) and range of other crops. Not included on Annex I of 91/414/EEC so no longer used in EU • Case studies France, Italy, Spain (monitoring data suggested failures of EQS, and location of previous production sites) • Data used includes questionnaire responses, available monitoring data, • Impacts if PS (including proposed EQS) • A few failures reported, although uncertainty since LOD > EQS in water, and since use has only recently ceased. Concentrations will reduce over time • If dicofol is likely to still be detected over EQS/PHS timescales, measures may need to be considered. Remediation of contaminated land, or, if detected, removal of dicofol from wastewater. However if ongoing detection only in biota, these may be of limited benefit • Resulting costs to water industry, public bodies and, if identifiable, historic polluters. Unlikely to be widespread and difficult to predict • Additional impacts if PHS • Measures and impacts expected to be similar as for PS • Uncertainties • Confirmation of whether ongoing production • Disproportionate cost based on 'die away'? Extent to which MS would be likely or able to implement measures • Ability to achieve required analysis standards in water

12. 17 alpha ethinylestradiol • Basis of assessment • Synthetic steroid used in oral contraceptives and for other medicinal purposes. Endocrine disrupting substance. • Case studies United Kingdom (predicted failure of proposed EQS) and Greece (relatively low use of contraceptive pill, for comparison) • Data used includes; information from MS, questionnaire responses, EUREAU, EFPIA and AESGP, available monitoring data • Impacts if PS (including proposed EQS) • Data indicates widespread EQS failures downstream of WWTWs • Measures required at European level- need for advanced wastewater treatment could be widespread • Additional impacts if PHS • Would require product substitution, although there are some available these are not all as effective in preventing unintended pregnancies. • Substitution may also lead to an increase in progesterone concentrations • Uncertainties • Predicted Environmental Concentrations are higher than proposed EQS but so too is the LOD, so not possible to check whether samples exceed EQS • Uncertainties in benefits of replacing one hormone with another.

13. 17 beta estradiol • Basis of assessment • Natural steroidal estrogen used as/in synthesis of oral contraceptive and hormone replacement. Endocrine disrupting substance • Natural emissions large percentage of total- esp from human and cattle excretions • Case studies United Kingdom (predicted failure of proposed EQS) and Greece (relatively low use of contraceptive pill, for comparison) • Data used includes information from MS, questionnaire responses, EUREAU, EFPIA and AESGP, available monitoring data • Impacts if PS (including proposed EQS) • Failures for the proposed EQS are likely to remain despite relevant agri measures that may be put in place during the 1st cycle of RBMPs (although difficult to predict extent to which RBMP measures will be effective) • Wastewater treatment and further agri measures may be required • Additional impacts if PHS • Likely to require cessation of use in pharmaceuticals, although natural emissions (human and livestock) will still continue • Treatment of sewage effluent will still be required to control natural human emissions (although this is not 100% effective, and non-human sources unaffected) • Uncertainties • Considerable uncertainty about extent to which measures will be need to be implemented. • Considerable uncertainty in the definition of the baseline, and amounts used by each MS and in what proportion for different uses. • Proportions of failures contributed from livestock vs human (natural vs pharmaceuticals)

14. Diclofenac I • Basis of assessment • Potent non-steroidal anti-inflammatory drug available by prescription and in OTC formulations. Not used in veterinary medicine in the EU • Case studies DE (predicted failure, data availability) and ES (different use pattern). Reflecting highest/lowest EU per ca use • Data used: KNAPPE, data from MS, questionnaire responses, Ineris (DE only) • Available use/PEC/WWTP efficiency data: there is a relatively high risk of exceeding the EQS. PEC for 10 MS – failures anticipated in DE and UK; potentially in PL, AU, IT and FR (but not in all MS) • Case study DE: failure anticipated; on average a 57% reduction in concentrations required • Case study ES: No anticipated failure. Per ca use more than an order of magnitude less compared to DE • Impacts if PS (including setting EQS for fresh/salt water) • Emissions are almost entirely from WWTPs (consumption or disposal of unused drugs). Some emissions from landfills. • Measures considered: end of pipe (WWTP, hospital and health care units WWTP, take-back schemes) and/or source control measures (good prescription practices, ERA, environmental classification, GPP, economic incentives, ecolabel etc.)

15. Diclofenac II • Impacts: End of Pipe measures • Costs to water industry (DE: costs of advanced WWTP such as UV and GAC including environmental costs (CO2, sludge, energy use); ES - none); costs to public authorities; costs to end users and society (higher water bills/ additional cost burden on hospitals) • Impacts: Source control measures • Contribution to overall reductions only- uncertain whether one of the source control measures identified or their combination would ensure that the proposed EQS are met (e.g. their effectiveness is unknown.) • Also the measures are unlikely to have a significant effect on concentrations in the aquatic environment over the timescale. • Discussion on the costs to pharmaceutical industry, e.g. costs of the schemes, costs associated with changing production to other drugs, costs to public bodies (in addition to monitoring), environmental costs (e.g. use of alternatives, waste) and costs to end users (e.g. price increase, substitution related impacts including suitability) • Uncertainties • No comprehensive data on consumption, disposal, emissions and environmental concentrations of diclofenac across the EU, e.g. no PEC data for 17 out of 27 MS • No quantitative data on relative contribution of different sources • Uncertainty about the anticipated failure and extent of the additional measures to comply with EQS, i.e. impossible to cost additional WW treatment for the EU • Uncertainty about effectiveness of source control measures (and costs)

16. Ibuprofen I • Basis of assessment • Non-steroidal anti-inflammatory drug used to treat inflammation, fever and pain (human use) • Case studies DE (predicted failure, data availability) and ES (predicted failure). • Data used: KNAPPE, data from MS, questionnaire responses, Ineris (DE only) • Available use/PEC/WWTP efficiency data: there is a relatively high risk of exceeding the EQS. PEC for 8 MS – failures anticipated in FR, ES, DE and UK; potentially in FI, IT, PL and RO • Case study DE: failure anticipated; on average more than 96% reduction in concentrations required • Case study ES: failure anticipated; on average more than 96% reduction in concentrations required • Impacts if PS (including setting EQS for fresh water) • Emissions are almost entirely from WWTPs (consumption or disposal of unused drugs). Some emissions from landfills. • Measures considered: end of pipe (WWTP, hospital and health care units WWTP, take-back schemes) and/or source control measures (good prescription practices, ERA, environmental classification, GPP, economic incentives, ecolabel etc.)

17. Ibuprofen II • Impacts: End of Pipe measures • Costs to water industry (DE and ES: costs of GAC including environmental costs (CO2, sludge, energy use); costs to public authorities; costs to end users and society (higher water bills/ additional cost burden on hospitals/ health care units) • Impacts: Source control measures • Contribution to overall reductions only- uncertain whether the measures (individually or in combination) would ensure that the proposed EQS are met • The measures are unlikely to have a significant effect on concentrations in the aquatic environment over the timescale. • Discussion on the costs to pharmaceutical industry (e.g. costs of the schemes, substitution), costs to public bodies (in addition to monitoring), environmental costs (e.g. use of alternatives, waste) and costs to end users (e.g. price increase, substitution) • Uncertainties • No comprehensive data on consumption, disposal, emissions and environmental concentrations across the EU • Use data (KNAPPE): prescription only, hence underestimate of total use quantities and PEC • Uncertainty about the anticipated failure and extent of the additional measures to comply with EQS, i.e. impossible to cost additional WW treatment for the EU • Uncertainty about effectiveness of source control measures (and costs)

18. Cyanides I • Basis of assessment • Naturally occurring compound. Produced and used in industry: chemical production, metal processing and production (I&S) and gold and silver mining. Also emitted from exhaust fumes. Cyanides occur in waters as free cyanides (the main toxic form) • Case studies NL (predicted failure, data), RO (predicted failure; data; “new” MS) and SE (gold mining) • Data used: data from MS, questionnaire responses, Ineris, E-PRTR • Impacts if PS (including setting EQS for fresh/salt water) • Point sources: gold mining, WWTPs, I&S production and organic chemical industries. Also discharges from historically CL • Diffuse sources: runoff from cyanide-containing salts used on roads, migration from landfills, agricultural and atmospheric fallout and washout and atmospheric emissions from metal (gold and silver) extraction • Failure anticipated in all MS for which data is available (but it is for total CN). • Reduction required in the case study MS: >98% (RO); >90% (NL); no data (SE) • Measures considered: end of pipe (WWTP (GAC), SUDS (infiltration basins and constructed wetlands), industrial WWTP (chemical precipitation), gold mining) and/or source control measures (e.g. reduction in use, substitution, voluntary, i.e. codes of practices)

19. Cyanides II • Impacts: end-of-pipe measures • Costs to water industry (NL and RO: costs of advanced WWT such as GAC including environmental costs (CO2, sludge, energy use)); • Costs of WWTP to industrial sectors (NL, RO and SE – unit based): not quantified on case study scale • Costs of SUDS (capital, O&M including CO2 costs – unit based): not quantified on case study scale • Costs to public authorities (including method development); • Costs to end users and society (higher water bills and/or product prices) • Impacts: source control measures • Costs to industry sectors (mining, metal, chemical, de-icing agents), e.g. associated with the use of alternative substances and/or process, capital costs of changing production processes and losses in revenues, environmental costs, costs to end users • Uncertainties • Emission data: E-PRTR data cover total CN only (no data on diffuse and small point sources) • No comprehensive data on environmental concentrations across the EU (12 out of 27 MS (Ineris) plus 3 MS (questionnaire). • Assessment of predicted failure: free vs total CN; LOD • Efficiency of measures: required efficiency is very high (above individual end-of-pipe measures while efficiency of source control measures is uncertain

20. Dioxins • Basis of assessment • Unintentionally formed and released from thermal processes involving organic matter and chlorine, as a result of incomplete combustion or chemical reactions. Also generated from natural sources such as forest fires and volcanoes. • Extensive regulation (EU/global) resulting in significant reductions • Case studies BE (high emissions to water), FI (failure) and UK (failure, data) • Data used: data from MS, questionnaire responses, Ineris, E-PRTR • Impacts if PS (including setting EQS) • Point sources: Pulp and paper, chloroorganic, textile industries and diffuse : landfill leakage, atmospheric deposition (incineration) • Measures considered: Primary or process-integrated (avoiding formation of dioxins) and secondary or end-of-pipe (removal from waste combustion (flue) gases; WWTPs are not included – air emissions are key) • Costs to industrial/ waste incineration sectors, domestic combustion sector, power sector, aquaculture, WWTP incl. environmental • Costs to public authorities: monitoring (case studies plus EU), remediation, fire prevention measures • Costs to wider society: increased prices of goods and services • Additional impacts if PHS • Complete cessation of emissions: dioxins are persistent. The measures discussed above plus remedial measures (CL, sediments) • Uncertainties • Unknown extent of failure • The impact of the measures taking place (not reflected in monitoring)

21. PCBs • Basis of assessment • Used widespread historically (electrical and hydraulic equipment and lubricants). Still present in older products of varying type and lifespan, although targets are set for safe disposal . Also produced unintentionally through combustion • Case studies CZ (failure, high emissions to water), CY (failure), LV (historic) and PT (failure, data) • Data used: data from MS, questionnaire responses, Ineris, E-PRTR, NIP • Impacts if PS • Point sources: not produced but some equipment still used; diffuse : road runoff, landfill leakage, atmospheric deposition • It is not proposed to set an EQS – no measures required • Costs to public authorities: monitoring (case studies plus EU) • Additional impacts if PHS • Measures considered: removal of PCBs in sediments and/or remediation of CL • Costs to public authorities OR industrial sectors: remediation • Costs to water industry incl. environmental IF PCBs are found in WW • Costs to wider society: no significant impacts • Uncertainties • It is unclear how much further contamination and remedial work might be identified and undertaken

22. HBCDD • Basis of assessment • Flame retardant in polymers, most commonly in insulation boards but also electronic equipment, textiles. Some variation between MS depending on fire regulations (less use in Scandinavian MS) • Case studies NL (production site; some monitoring data available) and UK (former production site, monitoring data available) • Assumes production and use will continue in future. This may not be the case if authorisation is required under REACH (as currently being considered) • Used available monitoring data (including studies provided by MS), EU-RAR and other literature • Impacts if PS (including setting EQS) • Likely to result in focus on need to ensure compliance locally. Could results in enhanced treatment being needed at production/ formulation sites or downstream STWs (not costed) • Additional impacts if PHS • Complete cessation of emissions likely to require cessation of production and use. Impact on single producer (NL), formulators of HIPS, EPS, XPS, textiles, Opportunities for producers of alternative insulation • More effective in assuring environmental benefit than PS status due to persistence and widespread occurrence (esp marine) • Uncertainties • Whether use will continue in baseline • Time to achieve benefits

23. PFOS • Basis of assessment • Historic use as surfacant (in fire-fighting foams), water/grease resistance, general coatings. • Now heavily regulated- POP, and REACH Annex XVII. Derogations for specific uses in: photography, semi-conductor, metal plating and aviation industries. Attempts to develop alternatives required • Case studies UK (undertook voluntary risk assessment and risk reduction strategy) and Germany (monitoring data available) • Assumes production/ use is only for derogations listed, and that these will only continue as long as alternatives not available. Assumes that ongoing users are already obliged to investigate alternatives and minimise emissions. Assumes main source historically likely to have been from fire foams (i.e. historic only) • Used available monitoring data (including studies provided by MS), voluntary risk assessment and other literature • Impacts if PS or PHS • Ongoing uses already required to minimise emissions and investigate alternatives, so these are baseline measures. If ongoing uses do not allow EQS to be met, or cessation of emissions within 20 years, assume only remaining option is cessation of use. Previous studies suggest some emissions will continue even from limited ongoing uses • Given recent derogation under REACH, expect cessation of remaining uses before alternatives have been developed to be disproportionately costly • Potential need for remediation of contaminated land or advanced treatment at sewage treatment works • Uncertainties • Further information required on likely development of alternatives for remaining uses • Time to achieve benefits