DIRECTORATE-GENERAL
ENVIRONMENT
Directorate D – Water, Chemicals and Biotechnology
ENV.D1 – Water
Brussels, 04.12.2009
Working Group E on priority substances
WG E Meeting
8 October 2009, 10:00-18:00,Centre A. Borschette(CCAB), Room 4D, Brussels
9 October 2009 9:00-13:00 Committee of the Regions’ – Jacques Delors building, Brussels
Draft Minutes
thursday, 8th October 2009 (10:00-18:00)
Chair: Jorge RODRIGUEZ ROMERO (DG ENV D.1)
- Welcome and adoption of the agenda
The COM(Jorge RODRIGUEZ-ROMERO (JRR), DG ENV.D.1, Chairman) welcomes all the participants.He presents the agenda, especially mentioning agenda item 5 will be addressed the second day due to availability of JRC representative, and emphasizing no timing is given, the objective being to go forward as much as possible on the first day.
The agenda is adopted with no additional suggestions from the participants.
- Adoption of minutes of previous meeting
The COM (JRR) emphasises the written comment from CONCAWE will be incorporatedin a new versionof the minutes and asks if participants want to comment.
No additional comment is made, thus the minutes of the previous meeting are adopted.
- Overall approach of prioritisation processPrioritisation process – report from the Expert Group –Overall prioritisation process
The COM (JRR) presents the situation as regards the prioritisation process, reminding the audience of the document presented in July on the overall process with the main steps, presents the situation as regards the discussions of the Expert Group meeting of September and the next steps of the process. He first recalls the principles embedded in WFD Art 16 and the proposed approach combining monitoring, modelling, RAR reports, targeted risk assessments, other sources of information and EQSD Annex III that are all subject to expert review to arrive to a final list and associated EQSs. He reminds the proposed targeted list of substances circulated in July and updated and the associated tasks of the Expert Group on Review (EG-R) agreed in July and discussed at the EG-R meeting on 21-22 September. He then presents the conclusions of the EG-R and next steps of the process. Overall and once the modelling based selection is finalised, PEC and PNEC information for substances ranking high in the various processes will be identified and used to derive a list of 30-50 substances. On these, a dossier will be prepared and will serve as a basis to select 10-15 substances on which the EQS will be derived. The dossier will contain the RAR, the monitoring database factsheet, the various checks conducted on monitoring data provided, the data sheet presented under agenda point 4 and any additional information provided by COM, MS or stakeholder.
He then summarises the EG-R conclusions, indicating 76 substances are identified with the modeling leading to around 350 substances on the list, and the need to deselect substances using various evidences or absence thereof. In particular taking into account information on pesticides, on representativity, in the RARand the collection of information on PEC and PNEC will allow to select 10-15 substances from the three main prioritisation pathways on which dossiers will be prepared.
He then indicates the next steps in the process with the preparation of documents for next EG-R meeting on 26-27 January 2010.
WG E members are invited to discuss comments received on the room document, on the outcomes of EG-R, and on the list of substances to react on wrong or missing information and suggest additional substances with relevant evidences before the 20th of November.
EEB reminds the EQSD 2008/105/EC objective is to protect adequately the aquatic environment and is thus surprised by the de-listing criteria based on lack of monitoring or other arguments that they consider irrelevant. If a substance is monitored, it should be ranked higher, and no RA was conducted on pesticides.
The COM (JRR) answers the overall process is to make a prioritisation as defined under WFD Article 16, for instance the de-listing of pesticides is due to the existence of dedicated reduction measures and absence of evidence that they are not sufficient to address the risk, and listing 300 substances implies a high load of work with no risk evidence. On pesticides, the EG-R reported a potential under estimation and asked to receive peak exposure information to reconsider the risk. However pesticides are subject to a relevant assessment, even if following a different methodology than RAR. The overall process is not de-listing but prioritisation, thus ranking, the candidate list stays open to any addition or change of rank, especially where a risk is identified with relevant evidences.
ES asks if the ultimate objective is to have 15 substances or less.
FI comment EEB by reminding the exercise is not only on prioritisation but also on other aspects like bio-assays, mixed toxicity…
CEFIC thanks for the clarification on the overall process, and mention they understood in EG-R that only monitoring and modelling based identified substances would be used.
CONCAWE mentions WFD Art16 says “widespread” that needs to be defined.
NL agrees with the previous comments and asks what is the situation as regards the small list of substances posing a risk for drinking water, and asks what will be the criteria for de-selection of substances.
The COM (JRR) confirms it is 10-15 substances, and reminds it is an on-going, cycle repeated exercise, and should address substances of EU wide concerns. He adds the COM has received mandate from the EP to cover Annex III substances and prepare dossiers, although it is clear that monitoring and modelling will provide the core information. The ambition is to have PEC and PNEC information from monitoring and modelling and prepare a first proposal of substances the EG-R should address ready for the meeting of January. The substances likely to pose a problem on drinking water are identified in the table in blue. For pesticides, if the peak information shows a risk, the rank will be revised. The criteria for the other substances need to be discussed, the objective being to identify around 10-15 substances from each of the three main pathways and thoroughly assess the robustness of conclusions derived from them: it is a substance by substance discussion targeted to a final proposal.
EEB asks if and how the lists of Endocrine disrupting substances are addressed, and asks how the bias towards only substances for which sufficient information is available is addressed, and how the case of substances found each time they are monitored will be addressed.
EUROMETAUX asks how long the substance specific process is foreseen to last.
Greenpeace asks what is the status of the substances de-selected in absence of evidence or of resources.
The COM (JRR) answersendocrine disruptors are included in the modelling part and JRC will detail this. For emerging substances, if sufficient information they are then included in ranking,for the others with no information, it is a concern raised by the EP but it has to be recognised it is not possible to regulate where no information is available. The substances however will stay in the candidate list, even with a low rank, to inform future prioritisation processes. To change this, the COM is supporting improvement of knowledge a.o. with NORMAN network, but also with the evaluation process through REACH, and the mandate of the EG-R is also to pull information on emerging substances in the next three years. Overall PEC and PNEC information from monitoring are readily available and will be end of October for the modelling, the EG-R will select 30-50 substances in January and discussion on dossiers will arise during 2010. Some dossiers will be straightforward and others more complicated but the timetable to comply is short with January 2011 as deadline for the EP, and thus EG-R activities will be intense.
The COM (Bernd Manfred Gawlik (BMG), JRC-IES)adds for endocrine disruptors JRC is in close contact with Norman network to bring assessment of emerging pollutants and validation of alternative tools on higher level to cover situations where a biological effect is detected that can not be explained by the identified substances.
The EUDA emphasises the need for a cost benefit analysis at EU level to ensure it is not local problem.
The COM (JRR) answers the representativeness is already considered in both monitoring and modelling approaches but impact assessment is also foreseen that will deliver also information. He concludes PEC and PNEC information will be made available as soon as possible, and ask members to provide additional evidence if any by using the datasheet template no later than 20th of November.
– State of play of modelling-based prioritisation methodology
The COM (Klaus Daginnus (KD), JRC-IHCP)presents the current state of play of the modelling based prioritisation, recalling its main compounds,with a combination of hazard and use assessment leading to a first ranking. The main sources of information identified or suggested by EG participants are used to define a starting list of 2034 substances. On this list a ranking is established using hazard assessment and scoring of P, B and T with a specific workflow for this last and experimental data combined with screening tools and modelling to draw a complete picture on each substance. It is then combined with exposure scoring based on a use index combining use location, from controlled to use in the environment, and production volume. The combination of these allows deriving a score, used to rank the substances. He then proposes to use a tool readily available with a two tiered approach to derive PEC and PNEC, and developed by ECETOC. He also proposes refinement of the results by peer review and addition from research results such as KNAPPE or NORMAN.
EEB mentions the existence of a wide database on pesticides and asks if it is still possible to add data. They also ask why it is focussed on PBT properties and not consider Endocrine Disrupting properties.
The COM (KD) answers it is too late to add new data, ED properties are difficult to consider in a prioritisation exercise because they cover non classical endpoint, whereas the current approach uses the classical one, and indicates Footprint project provides the latest information on pesticides.
LU thanks for the big work on more than 2000 substances and asks if the derivation of PEC PNEC will be made solely on the substances ranking high.
CONCAWE congratulates for the work and mentions ECETOC is in their view not the most appropriate for hydrocarbons and an alternative model exist they can provide.
DK stresses from the current lists it is not clear which substance is on top.
IT questions which of the PNEC from the three risk ratios will be finally selected and if it will be between these or harmonised.
CEFIC indicates a reality/robustness check is needed and available data need to be considered in the expert review.
NL indicates a reality check is needed on the modelling part and asks where and how it will be covered.
The COM (KD) answers PEC - PNEC derivation will be only on substances ranking high because it needs big work to extract the most characteristic exposure scenario. He says the tight schedule plan for pragmatic approach using available information, and discussions are still to be conducted on the summary table combining monitoring, modelling and RA. He proposes the PNEC is selected based on a data mining activity part of the expert review, and says data are available for the reality check.
The COM (JRR)concludes the modelling exercise will be reviewed by the EG-R
- Finalisation of the Report on prioritisation base on monitoring methodology
The COM (JRR) introduces the point, indicating the objective is to conclude this work and adopt the document in its final version.
The COM consultant(Alice JAMES (AJ), INERIS) presents the summary of the main comments received on the document, and how they are split between points to be addressed by the EG-R and comments considered in the report by adding or modifying the text. All other comments not addressed in the presentation are addressed in a dedicated compilation as a meeting document.
NLcomment that the realistic worst case used in the methodology taken from EU Risk Assessment Reports may underestimate the risk because using BLM the PNEC is dependant on local circumstances and they propose the EG-Rto check the methodology for risk assessment on EU level with this approach.
The COM (JRR)takes note of the comment and passes it to EG-R.He concludes the report will be updated to erase “draft” from the title and congratulates the working group on the fact that the intense workof the past 2 years is concluded with this final version.
4’Information on Prioritisation methodology for substances SVHC
The COM (Karola GRODZKI, DG ENTR, G2)indicates under REACH a group similar to WG E is dedicated to identify Substances of Very High Concern (SVHC) and prioritise. A first list was established, some substances excluded based on properties or uses and the list was distributed to Member States for comment and discussion at a meeting next week. She mentions the conclusions may be different from WG E on the respective substances to select because this group is not focussed only on environment or water but embed all SVHC under REACH. She will report back on progress at the next WG E.
- Technical Guidance on Mixing Zones
UK(John BATTY (JB)) presents the situation of the guidance. He reminds the overall principle based on a tiered approach using mixing zone for MAC-EQS and mixing zone for AA-EQS and with objective to be pragmatic by using fixed parameters and targeting the most appropriate level of scrutiny in line with importance of the problem. The drafting group is composed of MS and industry representatives and they drafted a document with decision trees for each tier, and associated discharge test software, released at the beginning of October. The next steps are then to receive comments, update the document and start testing in December, in order to have a final version for the next WG E and presented at the WD meeting in May. WG E members are asked to provide comments, test and identify gaps as regards their own situation and report back.
FI offers to contribute on lake mixing conditions and asks if the Tier 0 that starts with waterbody conditions should be understood as excluding those of good status.
UKanswers it should identify where a waterbody is influenced by a discharge and a substance, objective is really to target cases where a problem is identified.
DE congratulates for the pragmatic approach and document that allow avoiding unnecessary work. He asks to complete the introduction to explain how the guidance is embedded in the overall monitoring strategy under the WFD. For Tier 0 and 2 there was detailed discussion in the group. For Tier 4, it is not applicable to chemical status if there is no effect on ecological status: DE suggests this point is either deleted or restricted by saying it can only be applied to Annex 8 substances.
NL mentions it should help identify significant and less significant discharges. On chapter 8.1 Tier 1A the figure p29, for criteria 1 and 10% EQS, it is easy to have such situation in upper stream of big rivers but far less to downstream river: NL suggests to adapt the text and criteria to make it more flexible taking into account the location in RBD.
DK asks if their comments of last week were considered.
UKwill include the DE suggestion in the introduction, and recognise concern of tier 4, the drafting group considered field test is ordinary approach to complement information, but it will be reflected in document that for Annexe X it is not mandatory.
To NL, UKanswers it was debated within the group with conflicting views, a single value was adopted but it will be reflected in the document.DK comments were included. For the testing, it is recommended to use available data from current national databases.
The COM (JRR) concludes the testing phase will also raise questions and remarks, and deadline for comments on the document is on the 28th of October.
- Report from the Activity on Emissions
The NL (Jelka Appelman (JK)) presents progress on this activity.On the questions asked to the drafting group by WG E, on the need to consider point sources or not, the answer is no because they are subject to EU legislation that needs first to be implemented at national level, except where they contribute to diffuse emission, and the discharge point of a WWTP should be considered as point source. On the need to consider historical pollution, although they may form a big part of the total emission, they are subject to national or lower remediation and disposal activities and various guidances exist. Four factsheets were developed and commented: they assume full implementation of EU legislation, they are living documents and MS are asked to provide all possible national information (guidance, BAT…) to complete and update them. First conclusion from these is that for the four PHS, WFD goal of zero emission will not be met on time mainly due to historical pollution and current emission criteria. The factsheets will be provided to the WG E at the end of October for comment, then updated and discussed at the end of January for a final version ready for the next WG E.