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Agenda point 5: List of candidates substances for prioritisation and identification of the shortlist for preparations of dossiers Sub-group on Review of.

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Presentation on theme: "Agenda point 5: List of candidates substances for prioritisation and identification of the shortlist for preparations of dossiers Sub-group on Review of."— Presentation transcript:

1 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, January 2010 Jorge Rodriguez Romero WFD Team DG Environment, European Commission

2 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

3 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.

4 Overall approach to prioritisation

5 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 substances by selecting the first substances ranking highest from the various sources (RARs, monitoring and modelling) plus consideration of other sources (PBTs, SVHC, POPs, Annex III)

6 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 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

7 Actions agreed at the September meeting (see document 5.2a)
Nb. Actions Comments 1 Application of the ECETOC TRA tool to the substances ranking high in modelling Done. See document 4b and accompanying excel sheet 2 Application of the agreed criteria for pesticides/biocides will result in applying a 0 ranking to 162 substances (thus 161 left for ranking) Done. See excel sheet 5.1a (version 5 of the list of candidate substances), column "Screening of pesticides and biocides". The substances marked with a cross are given a 0 rank and are not considered further in the prioritisation process. 3 Information will be made available on peak exposures from the database for the EG to consider. If information shows that there may be a risk that has been overlooked, the ranking will be revised accordingly Done. See excel sheet 3b. 4 Application of the representativeness criteria in INERIS report results in 0 ranking for 10 substances (only those showing no risk from modelling) thus 151 substances left for ranking2 Done. See excel sheet 5.1a (version 5 of the list of candidate substances), column "Screening after a posteriori checks INERIS". The substances marked with a cross are given a 0 rank and are not considered further in the prioritisation process. 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

8 Actions agreed at the September meeting (see document 5.2a)
Nb. Actions Comments 5 Review of the RARs for the remaining substances (49 ESR, 16 pesticides and 2 biocides) to extract PEC and PNEC and possibly identify local risk only, which will then result in 0 ranking Done. See excel sheet 5.2b and folder 5.2c. See section 2.3 below in this document for further details. 6 Translation of the information to the candidate list: PEC and PNEC from RARs (ESR, pesticides, biocides) PEC and PNEC used in monitoring approach PEC and PNEC used in modelling approach Done. See excel sheet 5.2b. 7 Ranking of monitoring and modelling approach for all ranked substances (not only for those ranking high) Done. This information has been introduced in the list of candidate substances (document 5.1a): the columns "Monitoring-based INERIS" and "Modelling-based JRC" contain now the results of all substances that were ranked, not only for those that were ranked high. 8 Identification of substances by selecting the first substances ranking highest from the various sources (RARs, monitoring and modelling) plus consideration of other sources (PBTs, SVHC, POPs, Annex III) Done. Approach and results presented in this document.

9 Actions agreed at the September meeting (see document 5.2a)
Nb. Actions Comments 9 Basic information on reliability of the various PEC and PNECs will be made available for the EG Done. For the monitoring based ranking, the number of Member States providing data is indicated on the list of candidate substances, document 5.1a (column "Monitoring information available?"). Further information is included in the Monitoring-based ranking report and in the on-line factsheets (see document 3a). As regards the PNECs for water, the assessment factors are included in the excel sheet 5.2b. For the modelling based ranking the information on the derivation of PECs and PNECs is available in document 4a, 4b and accompanying excel sheets. For the and PNECs extracted from the risk assessment reports, the main conclusions and relevant information from the reports have been copied and pasted into Word documents to facilitate consultation (see folder 5.2c).

10 Actions agreed at the September meeting (see document 5.2a)
Nb. Actions Comments 10 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 Done. Proposals have been received from Germany, Sweden and EEB. See document 5.1b and 5.1c. 11 Up to this point to be completed at the latest by the end of this year Done. 12 Identification of leads for the preparation of dossiers for those substances On-going. Member States are invited by 11 January to indicate which dossiers they propose to prepare 13 In order to mobilise Member States resources for the preparation of dossiers, support to will be seek from WG and Water Directors Done. See documents 2a and 2b, minutes of the WG E in October and conclusions of the Water Directors meeting in November. 14 Next EG meeting January 2010 in Done. Scheduled for January.

11 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 ?

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

13 Comments to list of candidate substances (see document 5.1b)
General comments and candidate substance specific comments Who Comment Proposal NL Methodology to assess the risks of metals To be discussed later Endpoints for pesticides CEFIC Cyanides Acetonitrile Not included in the shortlist Nitrite Proposals to add additional substances to the candidate list Who Comment Proposal EEB Proposal on endocrine disruptors and pharmaceuticals To be discussed later SE Irgarol DE PFOS Included in the shortlist

14 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

15 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)

16 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

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

18 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 Stakeholders presenting 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.

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

20 (Eco)toxicological data for 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]

21 Toxicological data for derivation of Quality standards for protection of human health
At least 1 NOAEL or NOEC for derivation of QSbiota_sec pois (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]

22 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

23 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

24 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 # CAS Substance 23 Chloroacetic acid (MCAA) 104 Methiocarb 50 2,4-Dichlorophenol 122 Uranium 52 Malathion 123 Vanadium 53 Fenitrothion 134 Selenium 65 Diazinon 174 Pirimiphos-methyl 69 Triphenyltin compunds 197 Permethrin 73 Methidathion 199 Deltamethrin

25 2. The modelling based prioritisation
The results of the modelling based prioritisation are ranked on the basis of the PEC/PNEC ratio CAS Name PNEC (mg/L) Proposed PEC (mg/L) Proposed RCR chlorpyrifos 3,00E-06 1,12E+00 3,73E+05 ametryn 3,60E-06 2,02E-01 5,61E+04 Dichlofluanide 1,00E-05 3,09E-01 3,09E+04 prometryn 2,00E-06 4,07E-02 2,03E+04 ethalfluralin 4,00E-06 8,04E-02 2,01E+04 terbutryn 2,40E-06 1,70E+04 alpha-cyano-3-phenoxybenzyl 3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate 3,00E-07 3,72E-03 1,24E+04 chlorpyrifos-methyl 5,00E-05 5,62E-01 1,12E+04 methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate 3,50E-06 2,71E-02 7,75E+03 2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol 1,50E-05 1,14E-01 7,60E+03 chlorothalonil 6,00E-05 3,45E-01 5,75E+03 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol 8,45E-05 3,94E-01 4,66E+03 trifluralin 4,00E-05 1,84E-01 4,60E+03 Dimethyldioctadecylammonium chloride 1,59E-05 5,25E-02 3,30E+03 2-chloro-6-nitro-3-phenoxyaniline 1,45E-01 2,90E+03 propargite 1,29E-01 2,15E+03 hexachlorocyclopentadiene 9,00E-05 1,48E-01 1,64E+03 N-propyl-N-[2-(2,4,6-trichlorophenoxy)ethyl]-1H-imidazole-1-carboxamide 1,00E-04 1,60E-01 1,60E+03 Dicofol 8,80E-05 1,15E-01 1,30E+03 benfluralin 3,80E-05 4,54E-02 1,19E+03 clofenotane 5,00E-06 5,50E-03 1,10E+03

26 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 # CAS Substance 10 Edetic acid (EDTA) 92 Tert-butyl methyl ether (MTBE) 12 Aniline 172 1,3,5,7,9,11-Hexabromocyclododecane (HBCDD) 22 Acrylic acid 89 Chromium trioxide 43 Toluene 124 Zinc and its compounds 46 Piperazine 222 Phenol, 4-nonyl-, branched 74 2-methoxy-2-methylbutane 224 Alkanes, C14-17, chloro

27 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 # CAS Substance 71 Tolylfluanid 196 Cypermethrin 100 Benfluralin 199 Deltamethrin 101 Chlorothalonil 204 Propiconazole 104 Methiocarb (aka mercaptodimethur) 214 Aclonifen 288 Tri-allate 253 Quinoxyfen 114 Chlorpyrifos-methyl

28 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

29 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

30 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 # CAS Substance 4 Bis(tributyltin)oxide (TBTO) 51 2,4-dinitrotoluene 228 Coal tar pitch, distillates, pyrene fraction 62 Cyclododecane 21 Acrylamide 172 1,3,5,7,9,11-Hexabromocyclododecane (HBCDD) 28 Musk xylene (5-tert-buthyl-2,4,5-trinitro-m-xylene) 117 Arsenic and its mineral compounds 29 Benzylbutylphthalate (BBP) 119 Chromium and its compounds 41 4,4`-diaminodiphenylmethane (MDA) 120 Cobalt and its compounds

31 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 # CAS Substance Comment 8 Chlordane Banned as pesticide, no other sources of information for prioritisation 20 Heptachlor Ranked high in the monitoring based prioritisation 60 Chlordecone 90 Polychlorinated biphenyls (PCBs) Ranked very high in the monitoring based prioritisation, Annex III EQSD 96 Dioxin (2,3,7,8 - Tetrachlorodibenzo-p dioxin,TCDD) 98 Perfluorooctane sulfonic acid and its salts (PFOS) and perfluorooctane sulfonyl fluoride Voluntary risk assessment identified risk to aquatic environment, Annex III EQSD 105 Mirex 138 Toxaphene No other source of prioritisation 185 Hexabromobiphenyl 203 176 diphenyl ether, octabromo derivative (octoBDE or BDE-197) Ranked high in the modelling based prioritisation, PBT/vPvB 186 HexaBDE and heptaBDE (hexa and heptabromodiphenyl ether)

32 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 # CAS Substance Comment 7 Cyanides Ranked very high in the monitoring based prioritisation 10 Edetic acid (EDTA) Risk assessment conclusion iii for aquatic environment 26 Bisphenol A (4,4'-isopropylidenediphenol) 2008 update of the risk assessment concludes no risk to aquatic environment 28 Musk xylene (5-tert-buthyl-2,4,5-trinitro-m-xylene) Ranked high in modelling based prioritisation, PBT, SVHC 47 Dicofol Ranked high in both monitoring and modelling based prioritisation, PBT 77 Amino-methyl phophonic acid (AMPA) Identified in the INERIS report as potentially responsible for failures in the drinking water standard 78 Glyphosate 90 Polychlorinated biphenyls (PCBs) Ranked very high in the monitoring based prioritisation, POP 96 Dioxin 98 PFOS Voluntary risk assessment identified risk to aquatic environment, POP 116 Mecoprop (MCPP) Inclusion decision does not indicate the need to take measures to limit the risk to the aquatic environment 171 Bentazon 253 Quinoxyfen Inclusion decision indicates the need to take measures to limit the risk to the aquatic environment

33 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

34 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 ) by only one producer It is therefore proposed not to investigate further these two substances (Information extracted from the PBT assessment

35 Comments received (document 5.2d)
Comments received from NL, FR, SE, IT, CEFIC, Eurometaux and ECPA General comments proposed for discussion: Who Comment Proposal CEFIC Risk reduction strategies should be considered To be discussed later Different criteria used for chemicals and for pesticides/biocides Substance specific comments proposed for discussion: # CAS Substance 12 Aniline 22 Acrylic Acid 76 Tetrabutyltin 71 Tolylfluanid 46 Piperazine 353 Ametryn 312 TBMD 350 Prometryn 74 TAME 121 Copper 92 MTBE 114 Chlorpyrifois methyl 100 Benfluralin

36 Discussion General approach Substance specific discussion:
Who Comment NL Methodology to assess the risks of metals Endpoints from pesticides CEFIC Risk reduction strategies should be considered Different criteria used for chemicals and for pesticides/biocides Substance specific discussion: Substances in the shortlist in document 5.2a # CAS Substance 12 Aniline 22 Acrylic Acid (CEFIC information) 76 Tetrabutyltin 71 Tolylfluanid 46 Piperazine 353 Ametryn 312 TBMD (CEFIC information) 350 Prometryn 74 TAME 121 Copper 92 MTBE 7 Cyanides 114 Chlorpyrifos methyl (ECPA information) 100 Benfluralin Proposals for additions to the shortlist SE: Irgarol EEB: endocrine disruptors and pharmaceuticals NL: top ten pesticides

37 NL comments on general issues
General comments Member State/Organisation: suggestions/comments made Methodology to assess the risks of metals NL: We have doubts about the methodology to assess the risks of metals, for example copper. To our opinion the risk could be underestimated when using BLMs for deriving PNECs, and set the PNEC on a ‘realistic worst case’, and not correcting the PEC as is done at this moment. We brought up this comment earlier, also in the last meeting of WG E, and we appreciate it very much that this will be discussed in the next expert meeting. We would like to point out that with the current methodology the actual risks might be underestimated. To our opinion the assessment of risks is more complex, upstream-downstream and accumulation in sediment (in relation with the goal to prevent deterioration, and problems after dredging with dredging material) should also be taken into account in order to estimate the overall risks. We would appreciate it when the result of the prioritisation are reviewed taking these comments into account. Endpoints from pesticides NL: We have doubts about the use of endpoints from pesticides dossiers for the prioritisation process. As for the assessment for the authorisation of pesticides recovery could be taken into account. This is not the case for the assessment of risks under the WFD. So, when applying PNECs in the prioritisation process derived on basis of the goals of the WFD, this might lead to other outcomes. I refer to the overview prepared by the RIVM, which is already uploaded on CIRCA.

38 CEFIC comments on general issues (1/2)
Prioritisation based on RAR CEFIC: When the RAR are used to prioritize substances, the local character and the already agreed risk reduction measures should have been taken into account. Unlike the monitoring and modeling approaches, Cefic is of the opinion that full advantage has not been taken of all available information, leading to unbalanced conclusions throughout the full list. While the conclusions in the RARs are a good starting point, they do not fully justify that substances are figuring on a candidate list. Cefic therefore calls on the European Commission to carry out a further assessment of all the risk assessed substances included in the candidate list, rejecting from the final list all those substances for which the final ESR RAR shows no risk to the aquatic compartment and those for which risk reduction measures are already in place and effective, including measures from the application of the IPPC Directive. When considering the Risk Assessment conclusions no attempt has been made to assess if these have become obsolete due to other EU activities or legislation. Examples are cited in the section “Substance specific comments”. Indeed, when a Risk Assessment was completed and a substance was identified as posing a risk to human health or the environment it was subject to risk reduction measures. and industry were required to regularly report their progress in controlling/managing these risks to the Risk Reduction Strategy meeting. No attempt appears to have been made to look at the work of this DG Environment committee. Likewise the IPPC Directive is designed to reduce releases to the environment by putting in place requirements to use BAT (Best Available Technique) for production of high volume chemicals the so called BREF documents. The conclusions in the RAR for the aquatic environment were sometimes based on one or only a few cases, often of local nature. Cefic questions whether this justifies an EU wide monitoring scheme and recommends including the available information of the risk reduction programmes, following finalization of the RARs.

39 Risk reduction strategies (1/2)
# CAS# Name Source of prioritisation Recommendations for the risk reduction strategy 12 Aniline Risk assessment chemicals Comm recommendation OJ 8. For the river basins where emissions of Aniline may cause a risk, the relevant Member State(s) establish EQSs and the national pollution reduction measures to achieve those EQS in 2015 shall be included in the river basin management plans in line with the provisions of Council and Parliament Directive 2000/60/EC (Water Framework Directive). 22 Acrylic acid Comm recommendation OJ for Acrylic Acid used in wet polymerisation processes at downstream user sites (processing capacity > 500 t/a) and in SAP production: - that the European Commission should consider the inclusion of acrylic acid in the priority list of Annex X to Directive 2000/60/EC (water framework Directive) during the next review of this Annex and should consider measures such as harmonised requirements for prior authorisation of discharges and emissions into water for the respective plants 43 Toluene Commission recommendation OJ It is recommended: - that the European Commission should consider the inclusion of toluene in the priority list of Annex X to Directive 2000/60/EC (water framework Directive) during the next review of this Annex 46 Piperazine Commission recommendation OJ No reference to WFD 74 2-methoxy-2-methylbutane Commission recommendation OJ Relevant mainly for groundwater 10. Local emissions to the surface water should, where necessary, be controlled by national rules to ensure that no risk for the environment is expected. 11. The risk reduction measures recommended to protect the groundwater are considered sufficient to protect humans via the environment.

40 Risk reduction strategies (2/2)
# CAS# Name Source of prioritisation Recommendations for the risk reduction strategy 89 Chromium trioxide Risk assessment chemicals Commission Communication OJ It is recommended: — to consider including chromium in the revision of the list of priority substances under the Water Framework Directive (Annex X of Directive 2000/60/EC (4)) 92 Tert-butyl methyl ether (MTBE) Commission recommendation OJ Mainly relevant for groundwater It is also recommended that MTBE containing bottom waters of above-ground storage tanks be controlled by plant permits (23) or national rules. 124 Zinc and its compounds Commission communication OJ — to consider under Directive 2008/1/EC (1) and Directive 2000/60/EC (2) if additional risk management is needed for other sources of zinc emissions than those from the produced and imported chemical (for instance natural sources, mining activities, historical pollution and the use of other zinc compounds), which the risk reduction strategy has identified as contributing significantly to the emissions of zinc to the aquatic compartment, 224 Alkanes, C14-17, chloro No risk reduction strategy (there is a REACH Annex XV transitional dossier) 10 Edetic acid (EDTA) Risk assessment chemicals, Annex III Commission communication No reference to WFD 172 1,3,5,7,9,11-Hexabromocyclododecane (HBCDD) Risk assessment chemicals, PBT/vPvB, SVHC No risk reduction strategy (a draft is available)

41 CEFIC comments on general issues (2/2)
Prioritisation based on RAR Further the Risk Assessment Reports appear to have been viewed in isolation. This approach is inconsistent with that used for biocides and pesticides where no further investigation was proposed if the substance was not ranked high in any of the ranking exercises and not identified as PBT, POP, SVHC or Annex III. Cefic believes that this approach should have been used throughout and therefore that any of the risk assessed chemicals should be removed from the candidate list if they were, after evaluation, not ranked high in any of the ranking exercises and not identified as PBT, POP, SVHC or Annex III.

42 Substance specific comments
# CAS Substance 12 Aniline 22 Acrylic Acid 76 Tetrabutyltin 71 Tolylfluanid 46 Piperazine 353 Ametryn 312 TBMD 350 Prometryn 74 TAME 121 Copper 92 MTBE 7 Cyanides 114 Chlorpyrifos methyl 100 Benfluralin


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