DIRECTORATE-GENERAL
ENVIRONMENT
Directorate D – Water, Chemicals and Biotechnology
ENV.D1 – Water
Minutes of the Third Meeting of Sub-Group on Review of WFD Priority Substances Meeting
Brussels, 17-18May2010
Chair: John BATTY(JB) –DEFRA, UK
1.Welcome and adoption of the Agenda
Document:1. Agenda SG-R PS May 2010 at 4 May.doc
The meeting of the Sub-Group on Review of WFD Priority Substances List was introduced by the Chair (JB)who welcomed the participants. The agenda was endorsed.
2.Introduction
Adoption of minutes of previous meeting
Document:2. Draft Minutes of the 2nd meeting of SG-R.doc
The minutes of the last SG R meetingwere endorsed with no furthercomments or remarks.
Outcome of SCG and Working Group E meetings
COM (Jorge RODRIGUEZ-ROMERO (JRR), DG ENV.D.1) noted that the outcome of today's meeting will feed into the WG E meeting on 24-25 June. He referred to the discussions at the March WG E meeting, and the May SCG meeting regarding the Technical Guidance Document (TGD) onEQS derivation, and reported that the SCG had agreed that EQS derivation can proceed on the basis of the TGDas it stands even though it has not been endorsed officially yet.
Objectives of the meeting
The Chair (JB) referred to the dossier grouping document prepared by the Commission ("Selection of substances for EQS derivation" - available in CIRCA), providing an indicative ranking to facilitate discussion at this meeting. COM (JRR) thanked all those involved in preparing the dossiers. He noted that there is some variability in information content but that the dossiers provide a good basis for the discussions. He stressed that the dossier grouping document is not intended to present a Commission position or pre-empt the outcome of the meeting but to speed up discussion. He said that the objective of the meeting is to identify substances to take forward for EQS derivation. The recommendations will be presented to the WG E in June, thereafter to the SCG and the Water Directors. They will inform the Commission proposal.
The Chair noted that DK had also provided a paper proposing how to discuss the substances. He suggested that the meeting proceed by first discussing the "green" substances in the Commission document, then the "red" substances, then the "grey" substances, and that if any green or red substances required detailed discussion this should be postponed until discussion of the "grey" substances.
NL stressed the importanceofdistinguishingin the prioritisation process between scientific aspects and policy issues, i.e. between prioritisation– or not – onthe basis of Risk Characterisation Ratio (RCR) and prioritisation– or not – on the basis of absence/presence of regulatory measures. This remark was strengthened by the Chair (JB) who emphasised that the group needs to focus on technical criteria at the meeting, even though there will be or socio-economic issues to consider later.
The Chair asked dossier leads to be ready to present a brief summary of their dossiers to start the discussion of each, but stressed that the indicative ranking in the Commission document did not necessarily reflect the opinions of the dossier leads.
3.Information on the state of play of the EQS Guidance
Documents:3.a Draft Guidance on Environmental Quality Standards derivation after SCG 23 Feb 2010.doc
3.b NL proposal re look-out box.doc
3.c Request to SCHER for 24 March 2010 plenary final.doc
COM (Helen CLAYTON (HC), DG ENV.D.1) reported that the version of the TGD EQS agreed at the SCG in February had been provided to the SCHER. COM had requested an opinion by July, but the SCHER was unlikely to be able to provide an opinion before September. This week would see the first of four SCHER working group meetings to be held over the summer.
3.1.Final changes to document before SCHER consultation
The look-out box proposed by NL had been discussed with EFOA and a compromise text had been agreed. This had not been forwarded to the SCHER. Given that the SCHER was likely to propose edits to the TGD, these edits and the look-out box text would be provided to the SCG in due course.
3.2.Procedure and Timeline
Although an opinion from the SCHER would not be provided until Sept, the SCG had agreed that EQS derivation proceed on the basis of the TGD as it stands.
4.Selection of substances for EQS derivation
Documents:"Selection of substances for EQS derivation"(dossier grouping document),
DK room document,
Substance dossiers and Comments and background documents - see folder “substance_dossiers” available on CIRCA
4.1 General points of discussion
WFD aims versus PBT assessment
Some members of the sub-group(e.g. NL) noted that the PBT assessmentprocess should not be confused with the prioritisation process aimedatmeeting the WFD goals. NL added that the WFD requiresa quantitative approach in order to derivequality standards.
Controversies regarding the prioritisation procedure
-When dealing with the final “non-selection” of “green" substances, some stakeholders noted that decisions should not be taken too quickly when uncertainties remain.
-Greenpeace could see a case for selecting all 41 substances for EQS derivation, but acknowledged that time and resources constraints did not permit the spending of substantial time on every substance, nor theselection of all of them; however, they asked that each provisionally "green" substance be considered individually, time allowing, before deciding not to select it for EQS derivation.The UKqueried whether the goal of the meetingwas to select a small number of substances for EQS derivation or torank all 41 substances in order of priority.
The Chair (JB) and the European Commission (JRR) responded that it should not be assumed that “green" substances do not present any hazard but that the available evidence of risk to or via the aquatic environmentdoes not suggest that they should be prioritised at this point; they would be included in the next review.It was recalled that the aim of the meeting was to establish a list of substances to be prioritised for EQS derivation. It was stressed that the prioritisation process is an iterative processrepeated every 4 years.
-Some MS (e.g. UK) suggested splitting the “red substances list” into 2 parts: one to include substances the SG R is very confident about listing and another with more tricky substances where uncertainties remained.
This proposal was not retained.
-The fact that regulatory status should be taken into account was highlighted a number of times while discussing substances used as pesticides and/or biocides.
COM indicated that this element would be taken into account during the review as a wholebut that the meeting should focus onexperts’ consensus based on the use pattern, the physico-chemical and toxicological properties of the substances.
-Ann Dierckx (AD, CEFIC) stated that some substances which were put on the EQS Directive Annex III were, at the time the directive was published, considered of concern, but that evidence has since been gathered demonstrating that some of them do not need to be selected anymore.
Drinking-water issues
There were some discussions, especially in the context of glyphosate and AMPA,regarding whether drinking water issues should be taken into account in selecting substances for EQS derivation. The conclusion was that this protection objective would not be taken into account during the Sub-Group discussions but would be referred to the next WG E meeting.
Pharmaceuticals
AT made the general observation (in the context of clarithromycin) about pharmaceutical substances that they had entered the prioritisation process late, that there were few monitoring data, and that especially in view of EMEA's current efforts to refine the environmental risk assessment, consideration of pharmaceuticals should be postponed until the next prioritisation exercise.
Industry also commented on the late entry of pharmaceuticals into the prioritisation process.
WWF welcomed EMEA's activities but considered that pharmaceuticals should still be listed now where concern existed since this would already generate more monitoring data; EMEA was working at a more upstream level.
DK commented that it was inevitable that monitoring data would be sparse since the compounds are relatively new.
COM (JRR) acknowledged the late entry of pharmaceuticals into the process. However, COM noted that few countries (generally DE and CH) had provided monitoring data, therefore pharmaceuticals had not ranked high in the monitoring-based prioritisation. For the modelling-based ranking, data from e.g. NORMAN, KNAPPE had been investigated but the data had not been adequate to run the models. For this reason, MS and stakeholders had been given the opportunity to highlight substances of concern, and it had been agreed at the January meeting that dossiers should be prepared.
The substance-specific discussions held on the 41 substances for which a dossier was prepared are presented in alphabetical order in each section below, except for AMPA which appears afterglyphosate.
4.2Substances not selected for EQS derivation
Alkanes, C14-17, chloro (CAS 85535-85-9) - Medium Chain Chlorinated Paraffins (MCCPs)
The UK introduced these substances (provisionally grey-listed) by saying that they are persistent and toxic but do not meet the bioaccumulation criteria. Some uncertainty surrounds both the persistence and bioaccumulation status. Some monitoring data are available from the RAR.
CEFIC reported that several biodegradation studies are underway examiningMCCPs and Short Chain Chlorinated Paraffins (SCCPs) ; the persistence appears to begreater at higher levels of chlorination. Bioaccumulation is also being studied. The point was made that the substances occur as mixtures with different properties.Preliminary findings suggest that some components might be bioaccumulative, others not. The conclusion of the RAR was that MCCPs are not PBTs, but this status is still under review.CEFIC highlighted that although the RCRsin the REACH dossier were above one, theywere mostly based on predicted environmental concentrations, therefore theoretical; the work is being refined. Overall, the current evidence did not support the selection of the substance.
NL highlighted that SCCPs are on the priority substances list already and that their prohibition might lead to increased production and use of MCCPs.NL was not in favour of selecting this group of substances for the time being but suggested that a possible increase in the RCR should be borne in mind.for the next round of prioritisation. FR added that it was concerned that problems encountered with SCCPs might be repeated with certain MCCPs.
Reference was made to the analytical problems encountered in monitoring SCCPs that might be encountered also with MCCPs.Many MS and stakeholders agreed that analysis (especially choice of target) is problematic for these substances.CEFIC reported that a workshop on SCCP analysis had been held in February and work is ongoing. NL suggested that since MCCPs appear on the same chromatograms as SCCPs, MS could look at them simultaneously. The Chair suggested that the CMEP sub-group could be asked to look at the analytical issue as a prerequisite for any prioritisation of MCCPs. FR commented that CMEP's mandate could be extended from SCCPs to MCCPs. The Commission said that this point could be taken forward as a recommendation to WG E for the CMEP.
In the absence of conclusive evidence in favour of "red-listing", it was concluded that MCCPswould not be selected for EQS derivation at this stage.
Note:NL asked towards the end of the meeting whether MCCPscould be considered in the context of reviewing SCPPs, rather as octaBDE was to be considered when reviewing the existing EQS for polyBDEs. However,discussion of this suggestion was not pursuedbecause the representative of CEFIC for this substance had already left the meeting.
Bentazone (CAS 25057-89-0)
IT introduced this provisionally grey-listed substance, commenting that its use was decreasing in IT and that it might pose more of a risk to groundwater than surface water. (It had been noted in advance that peak transient concentrations might exceed the PNEC.)
Industry (BASF) commented that according to the criteria being applied to other substances, bentazone should be green-listed.
NL informed the group that bentazone is a Rhine-relevant substance – the AA-QS set by the Rhine Commission is 73 μg/l. This is much higher than the PEC1.
Based on the available evidence, Bentazonewas not selected for EQS derivation at this stage.
Bisphenol A (4,4'-isopropylidenediphenol) (CAS 80-05-7)
UK introduced this provisionally grey-listed substance, noting that there was considerable confidence about its ecotoxicity but uncertainty about possible reproductive effects on snails. Some weak estrogenic effects had been noted but did not qualify BPA as an endocrine disruptor according to the Weybridge criteria. Monitoring data were available from 13 MS which did not demonstrate risk.
The Chair noted that some revisions to the Dossier Grouping Document had been proposed by the industry on 10 May and that these were available on CIRCA;The main points were read out.
Industry (a consultant to Bayer) commented that the SSD approach included several species sensitive to endocrine disruption and the EQS could therefore be considered protective for sensitive groups. The issue to do with snails had arisen because of the decision to focus in the EU RAR on the particularly sensitive South American snail species used in the original investigations. It had since been recognised that an EU snail species should be considered, and the OECD had produced a detailed review paper earlier this year which was being followed up by the development of a life-cycle testing programme for snails. It would take a couple of years for the uncertainties regarding snail species to be resolved.
Greenpeace commented on the considerable uncertainties remaining. Although the Weybridge criterion was not satisfied (no effects on whole organisms) that did not mean there were no endocrine effects. Use of the recalculated snail study NOEC would lead to a lower QS. Greenpeace asked why the NORMAN monitoring data were so far above the JRC monitoring data. Overall, there did not seem to be a comfortable margin of safety. For these reasons, Greenpeace favoured red-listing.
Industry responded that the 2.1 μg/l NOEC (actually an EC10) from the recalculated snail study represented the most sensitive effect data reported. NL confirmed that this had been discussed in the Existing Substances Regulation (ESR) process, and although there were uncertainties, the RCR did not point towards listing.
SK commented that it has a national QS for BPA and that some exceedances have been measured. FR added that it was a substance of concern in FR. SE had also seen exceedances of the listed PNEC in STP effluents.
DE tended towards "green-listing" though it had done some statistical reanalysis which had left some uncertainties.Industry commented that this analysis was not in the public domain. For IT there were also some question marks; IT noted that EFSA was due to issue a new opinion on PBA in the context of human health at the end of May. AT had a national standard of 1.6 μg/l and had not measured exceedances, even in waste water (with one or two exceptions), but it too had some questions.
WWF mentioned that listing BPA would generate EU-level monitoring data.
COM (HC) explained that industry had suggested that the high concentrations recorded in the NORMAN database might be accounted for by proximity of monitoring sites to point sources. The data were from 89 stations in 2 MS. Another part of the database contained data from the Joint Danube Survey – the data (from 13 MS) were closer to the concentrations in the INERIS monitoring database (average 0.048μg/l; maximum 0.49μg/l).
The Chair reminded the Sub-Group of the need to take account of the EU RAR where available.
Based on the discussions held and the other available information, it was concluded that bisphenol-Ashould not be selected for EQS derivation at this stage.
Carbamazepin (CAS 298-46-4)
DE introduced this provisionally grey-listed substance commenting that the evidence tended towards red-listing (RCR around 1) but was not conclusive. There were enough data to derive an AA-QS for freshwater. A PNEC for sediment had been proposed, but partitioning to sediment was limited.
Industry (Novartis) felt that more aquatic and sediment data were required to derive a reliable EQS. It had repeated the Ferrari study and not found reprotoxic effects in Cerodaphniabelow 17 mg/l – data not yet published. This could be because a different clone had been used, but further investigation was required. A review of the sediment studies by Ternes was also required.
A discussion was held on whether monitoring data from1 MS (DE – plus CH) could be used to make EU-wide decisions. COM (JRR) commented that this was probably not an issue for substances used widely across the EU when similar use patterns could be assumed. Industry (EFPIA) commented that use patterns could vary depending upon prescribing patterns. (More information on this would valuable.) DK remarked that use in the Nordic countries was similar (according to a survey conducted in 2009).