DIRECTORATE-GENERAL
ENVIRONMENT
Directorate D – Water, Chemicals & Biotechnology
ENV.D1 – Protection of Water Environment
Brussels, 7 December 2009
Sub-Group Meeting on Review of WFD Priority Substances
DG Environment, Brussels
26 – 27 January 2010
Agenda item 5.1: Proposals and Comments Received on the List of Candidate Substances
Overview of proposals and changes done to the list of candidate substances
About the document:
The attached document has been prepared by DG Environment. It presents an overview of the comments received since October 2009and responses concerning the list of candidate substances (Annex 1 of the documentWG E(7)-09-03b - Updated version of the document Review of WFD Priority Substances List), presented by the Commission at the 7th WG Emeeting (08-09 October 2009).
The members of the Sub-Group are invited to:
Take note of the comments received and the responses by DG Environment
Comments received
Member States / Comments submittedThe Netherlands (NL) / 19 November 2009
Stakeholders / Comments submitted
European Chemical Industry Council (CEFIC) / 4 November 2009
20 November 2009
Greenpeace (GP) / 17 November 2009
PlasticsEurope (PE) / 20 November 2009
Proposals for substances to be added on the List of Candidate Substances
Member States / SubmittedEuropean Environmental Bureau (EEB) / 18 November 2009
Sweden (SE) / 20 November 2009
Germany (DE) / 20 November 2009
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General comments / Member State/Organisation: suggestions/comments made / Response by DG ENVMethodology 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. / To be discussed
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. / To be discussed
Substances that are relevant for drinking water / NL: The relevance of the methodology for the protection of drinking water: as brought up earlier with commenting on the TGD, we would also like to mention here too, that to our opinion there is a gap between article 7 and article 16 of the WFD, with respect to the methodology for the prioritisation process and the derivation of EQS. First of all parameters as smell and taste are not taken into account, however these are important parameters for the preparation of drinking water. Furthermore there is a difference in the setting of goals for drinking water under 98/8/EC (precautionary principle) and the WFD (effect-based principle). To my knowledge this difference in starting points is not discussed. If the prioritisation for substances that are relevant for drinking water is only based on toxicology and not on smell, taste and the precautionary principle, there appears to be a ‘gap’ between article 7 and article 16. For example substances that give problems for the drinking water industry, like MTBE /ETBE en diglyme will never be prioritised on basis of the current methodology, although these substances are an issue for drinking water on the European level.
If this issue not taken into account under this prioritisation process it should at least be recognized. To our opinion it is preferable that this issue is tackled on European level and/or that some guidance is given. / Environmental Quality Standards are set to protect human health and the environment (see WFD article 2.35). Article 16 covers risk to or via aquatic environment, including such risks to waters used for the abstraction of drinking water. The substances are prioritised on the basis of risk. We assume that this is what the NL comment refers to by "effects based". Following this, it seems that article 16 does not provide a basis for regulation of issues like smell or taste at EU level, but only provides for the protection from (eco)toxicological effects.
On the other hand, article 4.1.c and article 7.2 are clearly setting obligations for Member States to establish additional objectives (on top of good status) for water bodies that are used for the abstraction of drinking water. The driver is the compliance with the drinking water directive at the tap. If to comply with it a standard on the basis of the smell or taste is needed, then it needs to be developed and established as an additional objective for those water bodies in the river basin management plan.
The precautionary principle is one of the basis of the EU environmental legislation, as enshrined in the Treaty, so it is not exclusive of a particular directive.
Substances not prioritised because of lack of data / NL: We have doubts about some substances that seem not to be prioritised on basis of the current methodology as a result of missing data. For example PFOS: no monitoring data in monitoring based research, and no data on emissions in the modelling based research. Furthermore our experts have doubts about substances like glyfosaat/AMPA and linuron, which does not seem to be highly ranked. Therefore we would appreciate it when a reality check is performed. For example by comparative analyses on basis of reports (from drinkingwater industry, research institutes, watermanagers and specific pollutants reported by MS). / The objective of the preparation of the dossiers for specific substances is to bring all available information.
Specific comments/ suggestions / Member State/Organisation: suggestions/comments made / Response by DG ENV
EDTA (CAS number 60-00-4) / CEFIC: The confederation of European paper industries (CEPI), the International Association for Soaps, Detergents and Maintenance Products (AISE) and the European AminoCarboxylates Cefic Sector Group (EAC) have commented that EDTA should not be selected as priority substances or priority hazardous substances. Reasons were explained in a position paper attached. Background information on EDTA has been brought together in Factsheet template and this document is evenso attached.
CEPI, AISE and EAC noted differences between endpoints indicated in our EDTA WRRL fact sheet and the published EU RAR and between some end points (such as e.g. biodegradation and PNEC) presented in the excel sheet called the ‘Universe of Chemicals’. The information presented in the ‘Universe of Chemicals’ seems to be developed by using QSARs and EPIWIN type of programs in stead of actual test results. We feel that for EDTA the information from the enclosed EDTA WRRL fact sheet and the EU RAR should be used in the prioritization process in stead of the information presented in the ‘Universe of Chemicals’. / EDTA is listed in Annex III of Directive 2008/105/EC and therefore we think it is necessary to prepare a dossier that will be the basis of further discussion. The preparation of the dossier does not prejudge any conclusion. We think the information provided by CEFIC is very relevant and should be considered in the preparation of the dossier.
HHCB (CAS number 1222-05-5) and alpha-Cedrene (CAS number 469-61-4) / CEFIC: The Research Institute for Fragrance Materials (RIFM) is providing the following information on certain chemicals identified in the Priority Substance Review. HHCB (CAS# 1222-05-5) and alpha-cedrene (CAS # 469-61-4) are ranked ‘high’ based on the modeling approach used by the JRC to help set these priorities.
In the Excel spreadsheet summarizing materials for Priority Substance Review, there appears to be some omissions for the fragrance materials HHCB (CAS# 1222-05-5) and alpha-cedrene (CAS # 469-61-4). Both these materials were assessed by the TC NES as potential PBTs and both were determined not to be PBT materials. The TC NES summaries are attached.
In addition, the European Chemicals Bureau has recently completed its risk assessment of HHCB (Risk Assessment Report attached). The risk quotients for all environmental compartments were found to be <1. The ECB has concluded for this material (p.vii):
Environment
Conclusion (ii) There is at present no need for further information and/or testing and no
need for risk reduction measures beyond those which are being applied
already.
Conclusion (ii) applies to all compartments and all scenarios.
Based on the information provided, RIFM believes it is appropriate to delete these materials from the Priority Substance Review.
As background information, following documents are attached:
- EU RAR for HHCB,
- PBT assessment HHCB,
- PBT assessment alpha cedrene.
The JRC to consider these comments in finalising the report on modelling-based prioritisation.
Cyanices (CAS number 57-12-5) / CEFIC: The Cyanides Sector group already replied after the WG-E meeting of 6 July 2009.
Supporting vigilance in monitoring for presence of cyanides in water and sediment systems, the Sector Group feels that monitoring efforts for cyanide are better and more efficiently served by concentrating on the detection of cyanide (metal) complexes in regions where these are most likely to be manufactured and thus emitted. We feel it is more appropriate to make a clear distinction between freely-soluble cyanides and cyanide complexes, so as to reflect their differing behaviors in the environment.
Therefore the Cyanides Sector Group proposes to alter the priority listing from the current generic description of the cyanide ion to make the distinction between free and complex cyanides. We believe that this will provide for a more realistic and focused monitoring programme for cyanides as they are likely to exist in natural water systems, and particularly in sediment systems.
The comments prepared by the Cyanides sector group, are attached again for your convenience. / To be discussed
(Mono)Chloracetic acid (CAS number 79-11-8) / CEFIC: This contribution regards the discussion around the reporting of monitoring data regarding selected substances, especially with regard to our product (mono)chloro acetic acid (MCAA, CAS number 79-11-8). We very much support the suggestion INERIS made to consider MCAA as candidate for de-selection, after it’s a posteriori check based on the review of EU representativeness and quality/reliability of monitoring data.
In the communication so far MCAA has been indicated as a substance with high final priority for Water resulting in a high overall priority as well. From the received reports it cannot be judged whether the monitoring data indeed reflect justifiably that MCAA should be proposed for the priority setting as indicated. It remains unclear whether and at what level MCAA is detected in any of the reported monitoring studies. Determining a classification on just its initial effect on organisms in lab studies seems disputable for such an important intermediate chemical. Although we know that MCAA is toxic in aquatic organisms we also know that the substance is readily biodegradable and that treatment in waste water treatment facilities as currently used at our facilities is most effective.
Monochloroacetic acid (MCAA) is a strong acid which is freely soluble in water. It is synthesised in a closed system, and produced either in molten form, as crystalline flakes, in solution (80%), or as the sodium salt (SMCA). MCAA and SMCA are used almost exclusively as intermediates for the synthesis of carboxymethylcellulose, herbicides, surfactants, thioglycolic acid and in other production processes where carboxymethylation is required.
Some release to the environmental compartments may occur during production, transport and downstream use. MCAA/SMCA is rapidly degraded in the atmosphere, although low concentrations of MCAA have been measured in areas remote from anthropogenic emissions (as exemplified by pre-industrial ice samples). This is thought to be due to natural occurrence in the environment. If released into soil MCAA/SMCA will initially partition into the aqueous phase. MCAA/SMCA exists in water in the ionised state as the monochloroacetate anion; its properties will therefore be those of the salt in solution.
Monochloroacetate is readily biodegradable. It is rapidly degraded aerobically and anaerobically in soil and in the aquatic environment and will not exist as such for more than a few days. Due to its low Koc MCAA will not absorb into sediment and the log Kow -3.47 indicates that bioaccumulation of SMCA in aquatic flora and fauna is unlikely to occur to any significant extent. / No comment.
Tetradecane (CAS number 629-59-4) / CEFIC:The Cefic sector group “Hydrocarbon Solvents Producers Association” (HSPA) investigated the Annex 1 – candidate list of substances as well as the Excel sheet “Universe of Chemicals”.
The Sector group estimates that the data used (e.g. data from IUCLID) and the modeling approaches taken (e.g. QSAR modeling to estimate PNEC for the case of tetradecane) can result in an overestimation of the risk. More precise data that are available with industry will be delivered to JRC in the near future.
This will be done in the format of the templates, agreed upon in the Expert Group on EQS, example started with tetradecane (CAS # 629-59-4). / The approach does not intend to estimate the absolute risk but to provide a ranking.
Acetonitrile (CAS number 75-05-8) / CEFIC:This substance is not (acute) toxic for the aquatic environment and it is fully biologically degradable and not bio-accumulating. / To be discussed
Metacrylic acid (CAS number 79-11-8) / CEFIC: This substance is biologically degradable. / No comment.
Ammonium compounds (CAS number 7664-41-7) / CEFIC: Although these substances are toxic for the aquatic environment, they are only acute toxic and both fully biologically degradable and not bio-accumulating. / No comment.
Nitrite (CAS number 79-11-8) / CEFIC: Although this substance is toxic for the aquatic environment, it is only acute toxic and both fully biologically degradable and not bio-accumulating. / To be discussed
Bisphenol-A (CAS number 80-05-7) / PE: BPA is an Annex III substance for which a 2003 Risk Assessment Report and a 2008 update exist. The information contained in the completed template is substantially based on the updated risk assessment of 2008, which must be considered best available science for the substance. We note that the 2008 Risk Assessment Report produces PEC/PNEC ratios which are all less than unity, leading to conclusions of no risk.
We have received via CEFIC a table covering hundreds of chemicals and called “Universe of Chemicals” and a document called Annex 1 – Reduced List. Both documents have been circulated for consultation. We understand the information set out in these documents will be used to select substances of concern to be discussed in the context of the Water EQS Directive. Together with measured data, the table includes many modelled data, but does not give a clear explanation which parameters have been used to come to the results.
BPA is listed in row 37 of the Universe. The information given for a number of entries for BPA, which are likely to be highly relevant to the overall assessment, is not in line with current knowledge about BPA as set out in the EU risk assessment report of 2008. For example, BPA is not persistent but rather is readily bio-degradable.
Please find attached corrections and remarks for a revision for line 37, BPA, in the “Universe of Chemicals” spreadsheet. The explanation for the required revisions is in the row below the proposed revised entries. Work to adapt the modelled entries needs to be done by the authors of the table.
We also submit a revised version of the Annex 1 – Reduced List document, noting that BPA is not a PBT substance.
Sound science requires that measured data given in the EU risk assessment must take precedence over modelled outcomes. Therefore, the table as presented should not be used to drive any decision about BPA. Nevertheless, we believe the final version of the Universe of Chemicals spreadsheet, which is a document of record which may be used by many stakeholders, should be correct, and we kindly ask that you ensure that this is so.
In order to assist the Commission in its preparation of assessment of substances in the Water EQS Directive, we also submit a completed version of the “Template” document for BPA. The information contained here is substantially based on the updated risk assessment of 2008, which again must be considered best available science for the substance. Importantly, because there is a uniquely comprehensive and broad data set for BPA, we have included data from the species sensitivity approach which was used by the EU Member States to derive the NOEC in the EU risk assessment process.
In summary, we believe the recently published EU risk assessment report thoroughly assessed all concerns related to the environment and should be the basis for decision in Water EQS. The EU risk assessment clearly supports the conclusion that BPA should not be a priority or priority hazardous substance in the Water EQS Directive and that no specific water EQS for BPA is needed. / BPA is listed in Annex III of Directive 2008/105/EC and therefore we think it is necessary to prepare a dossier that will be the basis of further discussion. The preparation of the dossier does not prejudge any conclusion. We think the information provided by Plastics Europe is very relevant and should be considered in the preparation of the dossier.
PBT, POP and SVHC / NL: 28 Musk xylene: vPvB under TCNES / Yes, added
NL: 76 Tetrabutyltin compounds: PBT under TCNES (containts and degrades to TBTO) / Yes, added
NL: 96 Dioxin (2,3,7,8 - Tetrachlorodibenzo-p dioxin,TCDD) is certainly a POP under Stochholm convention / Yes, added
NL: 111 1,2,5,6,9,10-Hexabromocyclododecane (HBCDD) RAR and PBT assessment not necessarily restricted to one isomer: PBT under TCNES / Yes, added
NL:
113 2,2',4,4'-Tetrabromodiphenyl ether
176 diphenyl ether, octabromo derivative (octoBDE or BDE-197)
186 HexaBDE and heptaBDE (hexa and heptabromodiphenyl ether)
Technical Pentabromodiphenyl ether (peta-BDE):
Tetra- to heptabromodiphenyl etherPOP under Stockholm convention (may 2009) / Yes, added except the last one (Technical pentabromodiphenyl ether). It is an existing priority substance (see GP comment).
NL: 115 and further: individual PCBs should also be considered as POPs under Stockholm convention / Yes, added
NL: 346 Paraffin waxes and Hydrocarbon waxes chlorinated;paraffin waxes and hydrocarbon waxes, chlorinated;Paraffin waxes and Hydrocarbon waxes, chloro
SCCP (short chain chlorinated paraffins) identified as PBT under TCNES and SVHC under REACH / Yes, added
NL: For arsenic, cobalt, chromium only the listing of the substances as used is included in the SVHC list. In the environment these are of course arsenic, cobalt, chromium (CrVI?)and it compounds. In other words, they should be considered as SVHC. / Yes, added
Removal of existing priority substances / GP: the entry on the "list of priority substances in the field of water policy" for brominated diphenyl ether is a generic one, intended to cover a range of congeners, i.e. footnote iv of the priority list indicates that "these groups of substances normally include a considerable number of individual compounds. At present, appropriate indicative parameters cannot be given." 2,2',4,4'-Tetrabromodiphenyl ether is one of those many individual compounds, but a key one in terms of the toxicity, persistence and ability to bioaccumulate of the brominated diphenyl ethers as a group. / Agree. 113: 2,2',4,4'-Tetrabromodiphenyl ether (CAS number 5436-43-1)is deleted as being an existing priority substance.
GP: the more specific entry for (technical) pentabromodiphenyl ether (CAS
32534-81-9) on that list explicitly recognises that this technical "substance" is also a mixture of congeners, including BDE 47, or 2,2',4,4'-Tetrabromodiphenyl ether, i.e.:-"Pentabromodiphenylether (congener numbers 28, 47, 99, 100, 153 and 154)". / Agree. Technical pentabromodiphenyl ether (CAS 32534-81-9)is deleted as being a mixture of the following congeners: BDE-47 (38-42%), BDE-85 (2.2-3%), BDE-99 (45-49%), BDE-100 (7.8-13%), BDE-153 (5.3-5.4%) and BDE-154 (2.7-4.5%) that are already priority substances.
Annex 1 / Member State/Organisation: suggestions/comments made / Response by DG ENV
Proposals for new substances to be added in Annex 1 / EEB: For the protection of the environment it is vital to include pharmaceuticals and endocrine disrupting chemicals in the candidate list – Annex 1 to be evaluated in the following expert review. These concerns have already been discussed in several meetings. Pharmaceuticals and Endocrine Disruptors can due to their specific actions not be evaluated in the same way then other chemicals and are therefore not addressed adequately so far. There are many reports and scientific publications on these issues and it would be a serious shortfall if these substances will not be considered in a final evaluation.
More details are given in the letter accompany this proposals. / To be discussed
Please note that 16 of suggested compounds (carbamazepin, diclofenac, ibuprofen, naproxen, bezafibrate,atenolol, ciprofloxacin, erythromycin, gemfibrozil, Sulfamethoxazole,Clarithromycin, acetaminophen -twice-, 17alpha/beta estradiol, salicylicacid, clofibric acid) have been included in the list of universe of chemicals for modelling based prioritisation purpose.
SE: proposal for an addition to the Annex 1 of the document Review of WFD priority substances list:Irgarol. There are some new data that we did not have time to include, so the data sheet might need to be updated in the process ahead. For example, we just found this reference that seems to review the concentrations in Europe. / To be discussed
DE: proposesPFOS for inclusion in the Modelling exercise of the Priority setting. Enclosed to the proposal: Datasheet plus additional material regarding PFOS. The data are coming from a monitoring program in North-Rhine Westphalia and from ongoing national EQS setting procedure. / Included in the proposal for preparation of dossiers.
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