Sub-Group on Review of WFD Priority Substances List Centre Albert Borschette, Room 0A/4C

/ EUROPEAN COMMISSION
DIRECTORATE-GENERAL
ENVIRONMENT
Directorate D – Water, Chemicals and Biotechnology
ENV.D1 – Water

Brussels, 4 May 2010

Sub-Group on Review of WFD Priority Substances List
Centre Albert Borschette, Room 0A/4C, rue Froissart 36, Brussels, B-1040
17-18 May 2010
Agenda item 4: Selection of substances for EQS derivation

At the last meeting of the Sub-Group on Review (26-27 January 2010) 41 substances were identified for dossier preparation.

This document has been prepared to structure discussion at the meeting of 17-18 May (postponed from 20-21 April). It replaces the dossier-grouping document provided ahead of the original date.

The document summarises key information supplied in the dossiers. It also highlights areas of uncertainty or contention including points that have been flagged by rapporteurs or associated MS/stakeholders, although not all such points may be covered.

It also groups the substances into three groups for discussion: those that, on the basis of the information provided, appear to us to be least likely to be proposed for EQS derivation at this stage (green), those that appear most likely to be proposed (red), and those which might be described as particularly requiring clarification and/or more discussion (grey). More detail on the rationale for the green and red groupings is provided at the start of the document itself. The substances have been ordered according to the approximate order in which they are likely to be discussed. The order has changed slightly since the original dossier-grouping document was provided, as has the grouping of some substances as a result of further consideration of the information available.

Please note that the document is intended to launch and speed up the discussion and provide some structure to it, not to present a Commission view on the outcome of the meeting. It is based on the information in the dossiers, in the comments provided and in other data source documents. We may have misinterpreted some of the information/comments and welcome correction. Please note that the document is not comprehensive, i.e. it has obviously not been possible to include all the information relevant to each substance. Therefore the dossiers, comments and other information should be referred to. Please consider the document a working document.

Location of information in CIRCA:

Dossiers

http://circa.europa.eu/Members/irc/env/wfd/library?l=/working_groups/priority_substances/priority_substances_1/substance_dossiers/final_draft_dossiers&vm=detailed&sb=Title

Comments and background documents re dossiers:

http://circa.europa.eu/Members/irc/env/wfd/library?l=/working_groups/priority_substances/priority_substances_1/substance_dossiers/final_draft_dossiers/comments_background&vm=detailed&sb=Title

1. Introduction

In order to use the time most efficiently we propose to deal first with the substances that we think are least likely to be proposed for EQS derivation at this stage, then to discuss those which seem most likely to be proposed, and then to discuss those around which there is perhaps the greatest uncertainty.

Having said that, we consider that the pharmaceutical substances and artificial hormones should be discussed together during the later part of the meeting, irrespective of their tentative colour grouping.

2. Overview of dossiers – table

The table that follows is a working document, highlighting points for discussion etc. We have tried to include the key data on each substance, but some may be missing.

Please note that, in order to keep the document short, we have not included "negative" results, i.e. observations of what a substance is NOT, e.g. not a PBT, but we have tried to indicate where information is missing.

3. Criteria for grouping the substances as green or red

The columns in the table should be self-explanatory. In adding a colour code we have considered particularly whether the substance is PBT/vPvB/ED/CMR, whether the PEC/PNEC or equivalent ratio is greater than one, and what the regulatory status of the substance currently is, i.e. whether its use is restricted or banned. We have also considered the extent of the toxicity and monitoring datasets – in some cases this has accounted for coding as grey rather than green or red.

In general, if a substance is EITHER PBT/vPvB/ED/CMR AND/OR the PEC/PNEC ratio is >=1, it has been coloured red, unless its regulatory situation suggests this might or would not be necessary. If a substance is NOT PBT/vPvB/ED/CMR AND does not have a PEC/PNEC ratio >=1, it has generally been coloured green.

Green or red coding does NOT mean no room for discussion/debate. No assumption should be made about the outcomes, for example when considering whether to attend the meeting.

We hope that the discussion on all substances will be focused by this approach.

Notes

References to PEC1 and PEC2 are to the measured concentrations in the INERIS monitoring database.

References to PEC are to predicted environmental concentrations reported in the "estimated concentrations" section of the dossier and/or the JRC modelling database (proposed PEC).

Non-standard abbreviations

SCMS = substance of concern to MS

Overview of the dossiers

# / CAS # / Substances / Lead / General including reason for including in list of 40, and extent of use / PBT/endocrine disrupting/CMR/
other properties / PEC/PNEC ratios or similar comparison / Size and robustness of toxicity dataset / Size and robustness of monitoring dataset / Outstanding comments/controversies? / EQS derivation? Y/N
(water, sediment, biota?) /
101 / 1897-45-6 / Chlorothalonil
GREEN / NL / PPP (fungicide); phased out as biocide.
In Dir 91/414 Annex I
Mon-based prio: NA
Mod-based prio: 1
Production: 5-10 kt/yr (2000); (11.65kt/yr in JRC model)
Emissions: spray-drift, run-off. / PBT not investigated by EU PBT group.
Adsorption 330-7000 l/kg.
BCF< 100 l/kg. (QSsec pois not triggered)
Carc. Cat 3 (not classifiable)
Endocrine disrupting properties: no info.
Rapid biodegradation: DT50 2.5h in water/sediment system. / <=1
(Modelled JRC PEC = 345 µg l-1)
Monitoring datab:
90th %ile whole water, no separation: 0.03 µg l-1 ; mean 0.01; max 0.1 µg l-1
PEC1=0.04 µg l-1
PNEC=0.3 µg l-1
Sediment: 5-25 µg kg-1 dw
NL MEC freshwater: ~ 0.01 µg l-1
Tentative AA-QSfreshwater,eco=0.06 µg l-1
AA-QS marine water, eco= 0.012 µg l-1
MACfreshwater,eco = 2.0 µg l-1
Tentative QSbiota,hh = 0.913 mg kg-1 biota ww, corresponding to 4.0 µg l-1 / Ecotox data good for freshwater, limited for marine, non-existent for sediment (but AA-QSsed not triggered).
AA-EQS based on one of four chronic daphnid studies. Studies not available, therefore lowest value selected for derivation of the AA-EQS.
AF=10 for AA-QSfreshwater,eco
AF=50 for AA-QSmarine water,eco / Monitoring datab contains data from 4 MS for water, 1 MS for sediment. 1300 of 25890 analyses in water were quantified. Sediment analyses not quantified.
Not clear whether consolidated data on water include the UK's saltwater data. / N
1 / 52-68-6 / Trichlorfon
GREEN / FR / Pesticide/biocide.
Mon-based prio: H
Mod-based prio: 1
Use forbidden since Nov 2008(EC Reg 689/2008); not in Annex I of 91/414 since 2006.
No further emissions currently expected.
(JRC model: 1050 t/yr) / Evidence of potential endocrine disruption in humans (Cat 2), not in wildlife (Cat 3).
However:
Low Koc (6-79)
Low BCF (3.2 fish)
Biodegrades rapidly (5-20 d).
Hydrolyses to (among other substances) dichlorvos. / >1
(Modelled JRC PEC = 35.8 µg l-1)
PEC1 = 1.4 µg l-1 in water
Tentative AA-QS freshwater,eco = 5.6 x 10-4 µg l-1 / Fair.
Tentative AF = 10-100 / 7 MS have monitored in water, 1 in sediment. In water, only 10 samples of 13505 > DL, but in 95% of analyses <=DL, DL>2PNEC.
71 / 731-27-1 / Tolylfluanid
GREEN / FI / Sulfonamide pesticide & biocide.
To be withdrawn from Annex I of Dir 91/414 by June 2010 (see Dir 2010/20/EU).
In Annex I of Dir 98/8 (via Dir 2009/151) as wood and film preservative/antifouling agent. Restrictions on application as wood preservative. RAR re film preservation and antifouling use still being prepared.
Mon-based prio: -
Mod-based prio: 1 (but based on 2000 data)
Production: Lanxess Deutschland GmbH – only company marketing biocidal products containing tolylfluanid in EU.
JRC model: 2000t/yr. / Degrades rapidly into N,N-dimethylsulfamide. (N,N-DMS) (vP, DT50 water = 967 d) which may be transformed into N-nitrosodimethylamine (NDMA) by O3 during water purification. NDMA = genotoxic, mutagenic, carcinogenic (WHO info).
Endocrine disruption: no info / >1 if use JRC model data
Modelled JRC PEC = 46.1 µg l-1
Monitoring database PEC2 = 0.02 µg l-1.
PNEC not indicated in monitoring database or dossier.
JRC model PNEC = 0.196 µg/l / No data in dossier. / 2 MS (FR, IT) have monitored. All analyses < DL, unsurprising due to rapid degradation. / FI view: the need for deriving an EQS for the main degradation product, N, N-DMS, should be evaluated at a later stage, e.g. within CMEP Sub-Gp or as part of priority setting within MS.
309 / 1085-98-9 / Dichlofluanid
GREEN / COM / Biocide, wood preservative.
Not in Annex I, Dir 91/414
In Dir 98/8 Annex I as wood preservative (restrictions), not as masonry preservative; pending as film preservative, antifouling agent.
Mon-based prio: NA
Mod-based prio: 1
Production/use volumes: no info in dossier; (JRC model: 10 kt/yr) / Degrades rapidly (DT50 = 25.6h at pH 7) to N,N-dimethyl-N’-phenylsulfamide (DMSA), thence to the vP N,N-dimethylsulfamide. (N,N-DMS), which ozonisation converts to nitrosodimethylamine (NDMA) in drinking water (see above).
Koc = 1344
BCF (fish) = 72
Endocrine disruption: no info / <1 if accept PEC2
(>1 based on JRC model PEC)
JRC model PEC = 309 µg l-1
PEC2=0.025 µg l-1
(NB analyses not quantified)
Tentative AA-QSfreshwater,eco = 0.26 µg l-1 / Ecotox data fair for freshwater, none for marine. For sediment: DMSA chronic effects data.
AF=10 for QSfreshwater,eco
AF would need to be discussed for sediment. / Monitoring datab contains data from 4 MS.
16430 analyses in whole-water fraction (EU monitoring database) – none quantified, but in 97% of analyses <=DL, DL>2PNEC.
1 MS has monitored in sediment, no analyses quantified, but in all, DL>2PNEC.
NORMAN EMPODAT
River water (µg/l)
Avg = 0
Max = 0
(5 analyses – none above LOD) / Stakeholder position: rapid degradation to compounds less toxic for env, therefore not appropriate to derive EQS – ref to FI view re Tolylfluanid.
288 / 2303-17-5 / Tri-allate
GREEN / UK / Herbicide (selective)
In Dir 91/414 Annex I
Mon-based prio: -
Mod-based prio: 1
Use: 252 t EU sales (2009) ~ 6 MS.
(JRC model: 10.15 kt/yr) / PBT not investigated by EU PBT group, but
meets persistence criteria and is borderline for toxicity. Does not meet bioaccumulation criteria.
Koc = 4301
BCF=1400
Not readily biodegradable. / <=1
(JRC model PEC = 235 µg l-1)
Monitoring datab
Whole water:
PEC1= 0.118 µg l-1
PEC2= 0.0355 µg l-1
90th %ile (no sep) 0.03 µg l-1;
Sediment:
PEC2= 2.5 µg kg-1dw.
Tentative AA-QSfreshwater,eco= 0.4 µg l-1
AA-QSmarine water,eco= 0.04 µg l-1
AA-QSfreshwater,sed= 149 µg kg-1dw
QSbiota corresponds to 1.2 µg l-1 freshwater
QSbiota,hh corresponds to 1.04 µg l-1 freshwater / Ecotox data fair for freshwater, none for marine or sediment.
AF=10 for QSfreshwater,eco
AF=100 for AA-QSmarine water,eco / Monitoring datab contains data from 2 MS. Most analyses from FR. Only 2 of 21270 analyses in water were quantified.
1 of 565 sediment analyses (1 MS) was quantified.
28 / 81-15-2 / Musk xylene (5-tert-buthyl-2,4,5-trinitro-m-xylene)
GREEN (conditional on REACH decision ?) / AT / Synthetic musk – fragrance ingredient.
EU RAR
Annex III Dir 2008/105.
SCMS
Mon-based prio: -
Mod-based prio: 1
Voluntary ban on use as a fragrance ingredient July 2009 (new uses)/Aug 2010 (existing uses).
SVHC (REACH) => production and use expected to cease completely (already strongly decreased). Inclusion in Annex XIV of REACH to be decided ~ June 2010.
EU use (imported): 25 t/yr in 2008 – max now 67 t/yr.
If assume 67, emission to STP = 56 t/yr; discharge to freshwater =24 t/yr.
(JRC model : 1670 t/yr.) / vPvB
Carc. Cat 3, R40 (CMR WG May/Sept 2002). So far not in Annex VI of CLP regulation.
Evidence for endocrine disrupting effects not substantiated.
Not easily degradable.
Log Kow = 4.9
BCF>5000 / <1 (freshwater) cf >1 (regional PEC/biota)
PEC water(regional) = 0.18 µg l-1
CZ
MEC1= 1.92 x10-2 µg l-1
MEC2 = 3.76 x10-3 µg l-1
Tentative AA-QSfreshwater,eco = 0.56 µg l-1
Tentative QSbiota leads to 0.061 µg l-1 freshwater
EUSES calculations from RAR show marginal exceedence of derived EQS - based on worst-case emissions (2000) and behaviour in STP.
Monitoring data show no exceedence of EQS, but data very limited. Future emissions and concs in freshwater expected to be lower than in RAR => no exceedence . / Fair ecotox data for freshwater, non-existent for marine and sediment.
AF=100 (freshwater)
AF=1000 (marine) / Data from 3 MS (CZ, DE, DK) in monitoring datab, only CZ in water (19 of 663 analyses quantified).
No analyses quantified in sediment (1MS) or biota (1MS).
Other data from DE, IT, NL, NO, SE, UK, including for sediment and biota.
NORMAN EMPODAT
River water (µg/l)
Avg = 0
Max = 0
(6 analyses – none above LOD)
River biota (µg/kg)
Avg = 59.4
Max = 273
(36 analyses – 34 above LOD) / Extent of sorption to sludge and biodegradation not clear, therefore default STP distribution used, but aquatic emission load could be overestimated, sludge load underestimated.
334 / 42576-02-3 / Methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate (Bifenox)
RED / COM / Herbicide – post-emergence.
Dir 91/414 Annex I – buffer zones
Mon-based prio: -
Mod-based prio: 1
Use: Authorised in 19 MS.
Production and sales? No info in dossier. JRC model: 1000 t/yr.
(Marketed by Makhteshim-Agan (UK) Limited) / Not investigated by EU PBT group. Did not fulfil P criterion for Substances of Potential Concern under OSPAR Convention.
(Corr: Not POP).
Herbicide action: disrupts membranes, inhibits photosynthesis.