EUROPEAN COMMISSION
DIRECTORATE-GENERAL
ENVIRONMENT
Directorate D - Water, Chemicals & Biotechnology
ENV.D.1 - Water
12 February 2010
EXPERT GROUP ON REVIEW OF WFD PRIORITY SUBSTANCES LIST (EG-R)
SUB-GROUP OF THE WORKING GROUP E ON PRIORITY SUBSTANCES
DG ENVIRONMENT, 26-27 JANUARY 2010
Draft Minutes
First day of the meeting: 26 January 2010
Participants: Jorge RODRIGUEZ ROMERO (JRR), Madalina DAVID (MD), HELEN
CLAYTON (HC), Karola GRODZKI (KG), Ana PAYA PEREZ (APP), Klaus
DAGINNUS (KD), Alice JAMES (AJ), Benoît FRIBOURG-BLANC (BFB), Manfred
CLARA (MCl), Flemming INGERSLEV (FI), Susan LONDESBOROUGH (SL), Raphaël
DEMOULIERE (RD), Dieter SCHUDOMA (DS), Mario CARERE (MCa), Dorien TEN
HULSCHER (DTH), Eric VERBRUGGEN (EV), Concepcion SANZ MARTIN (CSM),
Niklas JOHANSSON (NJ), John BATTY (JB), Helen WILKINSON (HW), Ann
DIERCKX (AD), André LECLOUX (AL), Dolf VAN WIJK - Euro Chlor (DVW), Klaas
DEN HAAN (KDH), Mick HAMER - Syngenta (MH), Thierry SCHOONEJANS - Dow
(TS), Richard ALLEN - Bayer Cropscience (RA), Frank VAN ASSCHE (FVA), Ismene
JAEGER – EEB (IJ), Stefan SCHEUER – Greenpeace (SS).
1. Welcome and adoption of the Agenda
John BATTY (JB) and Ana PAYA-PEREZ (APP) welcome everybody. No comment being
made, the agenda is adopted and JB reminds the first session will not focus on substances
specific comments.
2. Introduction
Jorge RODRIGUEZ-ROMERO (JRR) welcomes all participants and introduces the “new
name” of the “group” which is not an “expert group” anymore but a “sub-group” of WG E
(even if it is still a group set up of experts). 2010 is a challenging year and the WD agreed
this group needs enough resources to meet the timescale: WD conclusions especially
stating this point are part of the documents for the present meeting.
1
A special WG E meeting was organised on the 12th of January: the EQS guidance was
discussed, some changes were made, and the guidance was endorsed and supported by the
working group with changes agreed. The TGD EQS will be ready by the end of the current
week and final version will be distributed beginning of next week and presented at the next
SCG meeting on 23rd of February. After this meeting, two additional consultations are
planned: an inter-service internal COM review (peer review) and a review by the SCHER.
The TGD EQS will also be presented to WD meeting in May.
JRR stresses that the current meeting is a key meeting with objective to conclude on the list
of substances on which preparation of dossiers will be needed, as support in the delineation
of the final list. The objective is to select a number of substances as low as possible and
comprised between 30 and 50 substances. The objective is also to share the work between
Member States (MS) and the Commission as leaders for the preparation of dossiers, with a
consultation with stakeholders and other MS before dissemination.
3. Review of the results of monitoring-based prioritisation
Benoît FRIBOURG-BLANC (BFB) presents the two products provided on the quality
check of the database. They are complementary to the first quality check made with the
monitoring-based prioritisation report. These products were asked and agreed by the EG-R
at the September meeting:
- the first product provides summary statistics and information on substances ranking high
or very high through monitoring-based approach and substances ranking high through
modelling (score 1). It is provided in the form of tables and graphs presenting quantified
and non-quantified analyses. It is available in the form of an information sheet for each
substance selected, a downloadable pdf file and accessible through the substances website
in a dedicated section.
- the second product is an excel file gathering summary statistics on 102 pesticides and
more specifically on the highest concentrations (peak measurements) found in the dataset
for these substances.
Mick HAMER (MH) asks what are PEC1 and PEC2.
BFB explains these are figures calculated as reported in the monitoring-based prioritisation
report, i.e. both values are 90th percentile of mean concentrations by stations, PEC1 being
based on quantified concentrations only while PEC2 is based on all concentrations by
stations, with values below DL being replaced by DL/2.
Klaas DEN HAAN (KdH) asks if the peak calculation could be made available for
substances finally selected during this meeting.
JRR answers the peak calculations were asked for by EG-R and its extension can be
envisaged if the group requires it.
4. Results of the modelling-based prioritisation
Jose ZALDIVAR COMENGES (JZC) presents the approach used for this part of the
prioritisation exercise: the screening including JRC proposal and additional lists proposed
by various stakeholder lead to 2034 substances. Each criteria used consist in deriving a
score. The first screening criterion is the hazard assessment using PBT (Persistent,
2
Bioaccumulative and Toxic) and ED (endocrine disruptors/disrupting) properties. The
second criterion is exposure, based on total production and use index. The combination of
both resulting scores is used to define a list of substances, and 78 substances are identified
in this first step. It is then necessary to make a PEC and PNEC estimation and calculate the
associated risk ratio to rank the substances, based on databases and available information.
Some results are presented on the top 20 ranked substances. The results are complementary
to the monitoring based approach with some uncertainties related to lack of (reliable) data
on some criteria.
Eric VERBRUGGEN (EV) mentions the first screening tier is based on “hazardous”
properties and then the second tier is based on PEC / PNEC ratio. Nothing further is done
with the hazardous properties of the substances in the final ranking. He asks thus why there
is so much emphasise on these properties in the screening phase.
Ismene JAEGER (IJ) warns that taking on board hazard and exposure the approach embeds
many substances but there is a need to take into account also the so-called emerging
chemicals such as pharmaceuticals and ED that are not with the current scheme, due to lack
of data. She adds that the substance-by-substance approach is not the only one, with the
need to consider toxicity of mixtures.
JZC answers this stems from the need to take into account both hazard and exposure, and
from the fact that the overall objective is to rank substances. He agrees the substance by
substance approach is insufficient and not protective enough and that this drawback needs
to be explored further in the future.
André LECLOUX (AL) says ECETOC TRA database used in prioritisation predicts high
concentrations, which is normal because this tool intends to be very protective to avoid
additional toxicity testing. He mentions it was said that production figures are not always
available and when several figures on use are found, choice is made to use the highest
emission value. He then asks what are the production figures used for the worst case
because if overall figures are difficult to find, how could production figures for a specific
use be found more easily?
JZC answers they used the worst-case scenario which may affect the results when data are
scarce.
MH requests for substances ranking high in the modelling-based approach that website fact
sheets are also made available with what is in the monitoring database.
Dorien TEN HULSCHER (DtH) asks if it would be possible to have an intermediate step
between final selection of substances on the shortlist and preparation of the dossier: some
substances selected could be found at a later stage as being not relevant and preparing a
dossier is a heavy work that needs to be correctly targeted.
JCZ mentions that this could be, in fact, the case where the substance has a RAR which
concludes on no risk for water, or the case where the substance is not anymore produced.
JRR recalls the decision taken at the September meeting where it was agreed modellingbased prioritisation results were used as they are provided, with the set of information used
to derive the substances, combined with the other lists and refined with the preparation of
dossiers. The list for which the group will prepare dossiers will be defined in the current
meeting, it is then necessary to find more technical criteria to select/deselect substances
from the list to reduce the overall effort needed. However, in the current meeting or when
preparing the dossier, if relevant technical arguments show that a substance is not to be
considered, then it can be the conclusion.
3
5. List of candidate substances for prioritisation and identification of the shortlist of
30-50 substances for dossiers preparation
5.1. Proposals and comments received on the list of candidate substances since
September 2009
JRR recalls the sequence of steps within the overall prioritisation process and the work
done since EG-R September 2009 meeting. He then presents the list of candidate
substances; the comments and proposal received and recalls the content of dossiers
required. He presents the final short list of substances selected for preparation of dossiers
and the current list of countries who proposed to take the lead on dossiers before the
current meeting and which should be finalised.
EV reminds the September meeting, where it was raised that some substances of annex I of
Directive 91/414 were not selected and says that in the current proposal they will not be
further investigated, whereas monitoring in the Netherlands downstream of big rivers show
that they are of concern.
DtH asks what the state of play of the use of peak exposure measurements is within the
overall process.
JRR answers that elements were provided for the MS and stakeholders (EG-R) to look at
and use to propose additional identification criteria and support their views. He then
presents the summary of comments and additional substances proposed.
Alice JAMES (AJ) then presents the essential data needed in the dossier so that the
dossiers are a strong basis for the derivation of EQS.
Discussion:
-
Flemming INGERSLEV (FI) + MH: do all data need to be reported (e.g. REACH
data)? Because this represents quiet a huge amount of work.
 AJ answers the aim is not to report the whole set of available data but to refer as
much as possible to already validated/compiled data and to report only core data
to determine QS.
-
KdH argues the most secure toxicological data is not a good term to use because we
shall not choose systematically the lowest data
 AJ precise “the most secure” does not necessarily mean “the lowest data”, but
“realistic worst case” based on relevant validated data, it may be replaced by
“the most conservative”, if too controversial.
-
DtH says good quality data are the most relevant ones but that this implies high
costs and the need to be sure the selected substances are relevant in a first step.
-
Dieter Schudoma (DS) asks if all data should be presented or only those relevant
for standard derivation.
 AJ mentions that the overall objective is to refer as much as possible to the
work done already and validated at a certain level.
 JRR adds it is not a scientific validation work but an identification of the most
available recent and relevant information, peer reviewed or validated at MS or
other level. Evidence of risk will lead to inclusion and provide elements for
EQS derivation. Preparation of dossiers will be uneven, with some needing 2-3
4
days and others with many data requiring more. This is under the remit of the
sub-group on Review, completed by extensive consultation during the process.
JRR presents then document 5.2a with the information sources used to define the sub-lists
of substances finally selected for the prioritisation exercise:
-
the monitoring-based list, with de-selection of 14 substances only selected through
monitoring and for which rank is due to a fraction with less than 4 countries
reporting,
-
the modelling-based list of substances with the highest risk ratio,
-
the list of substances based on final Risk Assessment Reports with risk for aquatic
environment other than local involving few sites,
-
the list of substances based on final risk assessment reports for the remaining 11
pesticides. This number is defined after de-selection of a) all authorised substances
with no other information source and b) those not ranking high in any prioritisation,
and ranked with the Toxicity Exposure Ratio (TER). 2 substances are proposed for
de-selection due to monitoring-based ranking.
-
the list of substances based on final risk assessment reports for the remaining
biocide, after de-selection of a) all authorised with no other information source and
b) those not ranking high in any prioritisation process (nor monitoring-based, nor
modelling-based),
-
the substances selected through other sources of information:
o PBT/ vPvB properties, criteria associated high rank of substances in
monitoring and/or modelling approaches. Three substances are only
identified with this criterion and not in monitoring/modelling, and are
proposed for de-selection.
o Substances of Very High Concern in the context of REACH (SVHC): 12
substances selected.
o POP with no addition based on these sole properties
o Citations in Environmental Quality Standards Directive (2008/105/EC)
annex III: some substances not already selected and added.
-
proposals from Sweden (Irgarol) and the European Environmental Bureau
(pharmaceuticals and ED) added to candidates for discussion
DtH mentions Chromium and Arsenic are on the list of Rhine relevant substances.
EV adds deselection of these substances is based on monitoring only.
JRR confirms that these substances were not considered in the modelling-based
prioritisation process and adds there deselection is due to the so-called a-posteriori checks
on monitoring datasets. He reminds that even if other datasets exist, the agreed process is
to rely on available European monitoring data gathered for the exercise.
5
5.2. Identification of the 30-50 shortlist of substances to prepare dossiers / 5.3.
Discussion on the proposal for a shortlist of 30-50 substances to prepare dossiers
Warning: for more details on the process, the dossier content or any comment, please
refer to document 5-Shortlist PS Sub-Group Jan 2010.ppt available on Circa
JRR briefly introduces document 5.2d that gathers general and substance specific
comments and issues received since the EG-R September meeting and proposes to focus
the afternoon discussion on each comment, to conclude.
Various general comments are made on the overall process and its associated reliability:
-
Mario CARRERE (MCa) and Frank VAN ASSCHE (FvA) feel concerned by the
equilibrium between the various pathways considered, with more emphasise on
monitoring and modelling approaches. They say that when a substance is selected
only on the basis of RAR or PBT properties it should be completed by other sources
of prioritisation because it could be based on old/outdated data.
-
AL adds risk reduction strategies should lead to reduction of concentrations.
-
Karola GRODZKI (KG) reminds the sub-group that substances not on the list
should not simply be forgotten.
-
Raphaël DEMOULIERE (RD) proposes conversion of concentrations between
biota and water to take into account all the substances that are ranking high/very
high for biota but not enough countries were represented so they failed the “EU
representative criteria”.
-
DtH and EV suggest exploring this in future prioritisation for improvement of the
process.
-
MCa highlights that in the document PAH are mentioned as already on current PS
list. He reminds PS list contains only 6 indicative PAHs for PAH group and pyrene
is not part of them. Therefore, de-selection cannot be based on that criteria and he
suggests changing this formulation. EV supports this proposal.
 JB answers the problems highlighted have to be taken into account together with
a balanced effort and ads that dossiers will also identify major gaps in knowledge.
 JRR says the approach chosen is the best possible weighted approach and an
iterative process, which comes from extensive shallow analysis to a more in-depth
one for a limited number of substances. He adds that dossiers will be used to
conclude on the selection of substances. On the issue of already existing priority
substances and their EQS revision, a separate process is planned.
JRR then presents the general comments in detail.
-
The Netherlands comment on the use of BLM to derive PNEC that poses a risk of
underestimation.1
 Katrien DELBEKE (KD) answers that using the realistic worst case provides the
same conclusion with corrected or non-corrected PEC and PNEC values.
1
for more details on this comment, please refer to document 5-Shortlist PS Sub-Group Jan 2010.ppt available
on Circa
6
-
DtH argues on the fact that some data from pesticides dossiers have been used for
prioritisation process while they should not have (because they take on board some
WFD irrelevant criteria such as recovery, etc.)
DS supports EV and DtH and suggests a review of pesticides selection.
 JRR mentions the annex of monitoring-based prioritisation report dealing with
choices made for the use of mesocosms data and choice made for derivation of
PNECs. He also mentions the online factsheets to check when a substance specific
question arises.
-
Ann DIERCKX (AD) comments the fact that risk reduction measures, BAT and
BREF have not been taken into account and that RAR were viewed in isolation for
substances other than pesticides and biocides.
 JRR answers this would lead to a too high complexity because this would mean
working at a regional/basin scale, and BAT implementation is very varying between
countries, but if information are available that make the conclusion change, it has to
be provided. In addition risk of local nature should lead to inclusion in RBMP and
deselection for the shortlist. Moreover, for risk assessment reports for biocides and
pesticides, they do not use the same approach as for other substances, and
conclusions are different.
JRR proposes not to select some substances for dossiers because some risk reduction
measures are in force at the moment (5 substances concerned). He adds that for those
substances with mainly a local risk (aniline, piperazine, TAME), these reduction measures
are best taken on board by national rules. Moreover, acrylic acid is also deleted from the
shortlist, based on information sent by the industry (CEFIC). The document sent explains
that RAR was written before the establishment of a wastewater treatment plant and that it
concerns one or two plants thus local.
JB adds that if a different conclusion than that of the risk reduction measure process exists,
it needs to be backed with good arguments.
Everybody agrees with the fact that aniline + piperazine + TAME + acrylic acid shall not
be on the short list anymore.
JRR proposes to delete the following substances from the shortlist:
-
Aniline
Acrylic Acid
-
Tetrabutyltin
Tolylfluanid
-
Piperazine
Ametryn
-
TBMD
Prometryn
-
TAME
Copper
-
MTBE
Cyanides
-
Chlorpyrifos methyl
Benfluralin
RD asks why we should delete aniline from the shortlist while it partitions mostly in water.
JRR answers the fact that aniline partitions to water is not a good reason for keeping it on
the list while there are risk reduction measures that are to be applied at national level to
take on board the risk.
JB proposes to focus first on the substances proposed for de-selection from the shortlist
and discuss afterwards the remaining ones.
-
TTBT deselected (RD suggests considering the whole family of TBT substances so
keep selected, but EV says it degrades into an existing priority substance, i.e. TBT)
7
 Conclusion: deselected from the shortlist
-
TBMD + Acrylic acid: CEFIC will provide updated information on solubility and
production volume
 Conclusion: deselected from the shortlist
-
Chlorpyrifos methyl:
 Thierry SCHOONEJANS (TS) mentions a very low level of detection.
 JRR: true. Monitoring approach reports 24 quantified analysis / 34403 analysis
in total
 AJ adds that with 24 analysis the rank is estimated still “High” priority, based
on data from 4 different MS (cf. Annex XII of the monitoring report)
 EV adds chlorpyrifos is an existing priority substance
 Conclusion: a “quick and dirty” dossier (i.e. no “dossier” as such) shall be
set for this substance. First thing to check will be to assess whether modellingbased approach conclusions are realistic or not based on new data provided by
ECPA. Then, the sub-group will decide if a dossier is needed or not.
-
Tolylfluanid:
 Is in last (2009) update of annex I pesticides Directive (i.e. authorised
substance)
 APP stresses a complete and comprehensive dossier is available as well as a
summary report on DGENV website. Quantities are low and uses are very
restrictive.
 DS indicates it is banned in DE because degradation product was found in
drinking water
 EV proposes that ECPA provides new information on use volumes and
emissions
 dossier will be taken on board by Austria and/or Finland
-
Ametryn + Prometryn:
 MH says these substances are no longer in use so there is no need to keep them
on the shortlist.
 Conclusion: deselected from the shortlist
-
Copper:
 JB reads the letter sent by Eurocopper mentioning voluntary RAR, peer
reviewed in 2009.
 FI mentions antifouling and other biocide uses are not considered in the EU
RAR which is in addition based on EU15 and not on EU27.
 KD says some of the uses were not included but two additional assessments
were conducted of which one on emissions, and the final risk assessment was
based on monitoring data (i.e., all uses covered). On the other hand, monitoring
data were also assessed under the monitoring based prioritisation which covers
EU27.
 Niklas Johansson (NJ) mentions also the need to consider additivity with zinc
(e.g. for effects on algae) and toxicity in soft freshwaters.
 KD says it is not possible to add additivity criteria at this step of the process,
when it has never been considered earlier in the overall process. Moreover, a
8
specific study conducted in Sweden showed no problem on the specific case of
soft freshwaters.
 NJ does not agree with the conclusion of this study.
 MCa mentions that Italy was rapporteur for Copper and report was peer
reviewed by SCHER. The current selection process should therefore use RAR
conclusions as well as monitoring and modelling-based results,
 RD mentions maybe one should look at MS specific pollutants.
 JB recalls that copper was on the first candidate list presented at WG E in
October 2009 (annex I candidate list) but deselected because it has no PBT
properties.
 KD says the RAR concluded that although of widespread use, only some local
problems were found for copper, thus not requiring EU wide risk reduction
measures.
 KG supports KD on the fact that the RAR concluded on a local risk only.
 Conclusion: deselected from the shortlist
The meeting is closed at 18:00
9
Second day of the meeting: 27 January 2010
Participants: Jorge RODRIGUEZ ROMERO (JRR), Madalina DAVID (MD), Karola
GRODZKI (KG), Ana PAYA PEREZ (APP), Klaus DAGINNUS (KD), Jose ZALDIVAR
COMENGES (JZC), Alice JAMES (AJ), Benoît FRIBOURG-BLANC (BFB), Manfred
CLARA (MCl), Flemming INGERSLEV (FI), Susan LONDESBOROUGH (SL), Raphaël
DEMOULIERE (RD), Dieter SCHUDOMA (DS), Mario CARERE (MCa), Dorien TEN
HULSCHER (DTH), Eric VERBRUGGEN (EV), Concepcion SANZ MARTIN (CSM),
Niklas JOHANSSON (NJ), John BATTY (JB), Helen WILKINSON (HW), Ann
DIERCKX (AD), Andre LECLOUX (AL), Dolf VAN WIJK - Euro Chlor (DVW), Graeme
WALLACE (GW), Alain CAVALLERO (AC), Klaas DEN HAAN (KDH), Mick
HAMER - Syngenta (MH), Thierry SCHOONEJANS - Dow (TS), Frank VAN ASSCHE
(FVA), Katrien DELBEKE (KD), Ismene JAEGER (IJ), Ulrich BORCHERS (UB).
5.3. Discussion on the proposal for a shortlist of 30-50 substances to prepare dossiers
(continued)
-
Cyanides:
 JB mentions the comment from CEFIC asking to distinguish free cyanide and
cyanide complexes with very different behaviour in the environment. He
reminds cyanides are on Environmental Quality Standards Directive
(2008/105/EC) Annex III, thus a dossier will be prepared but if this distinction
is to be made, it will structure the preparation of the dossier. He adds that in the
UK, free cyanide is the monitored chemical species.
 FI says substances complex binding to other substances in the environment, like
metals, is common and thus asks if the sub-group is dealing with the substance
before it enters the aquatic environment or not, what are the effects of these
complexes and are these complexes reversible?
 EV says that based on a study conducted in 2001, equivalent level of concern
between complexed and not complexed cyanides are raised and difference in
toxicity is low. Reversible forms in the environment.
 JRR asks if the monitoring data from 12 countries in the database are on free or
complexed cyanides, and Annex III says free cyanides.
 AD specifies sector group question about cyanides was because sediment
monitoring used for prioritisation is provided with CAS code for free cyanides,
whereas it can be biased by complexed cyanides species.
 KDH says that distinction between free and complex is needed when measuring
toxicity, as in the case of complex, toxicity can come from complexed metals.
 Conclusion: JRR concludes that free cyanides dossier will be lead by DG ENV
consultant, but all supporting documents and comments are welcome.
-
Benfluralin:
 TS says benfluralin is a Directive 91/414/EEC Annex I substance and adds
there is “no reason for concern” as benfluralin disappears rapidly in the
environment.
 DTH says one of the reasons for preparing dossiers is to do an in-depth
assessment of the substance (e.g. re-evaluation of the PEC).
 Susan Londesborough (SL) supports the Dutch opinion to make a dossier.
10
 N.B.: there are errors in reporting of results for benfluralin in document 5.2a
and 5.2b (sheets “Results 1” and “Proposal dossiers”. Where Benfluralin should
be flagged “Risk Assessment Pesticides + Modelling”
 JZC says it was agreed to update the modelling-based prioritisation, based on
specific use information and production volume.
 Conclusion: ECPA is invited to provide more data so that the group is able to
conclude on the assessment of the substance by a dossier or not.
-
Proposal (SE) to include irgarol in the shortlist and to make a dossier:
 NJ mentions irgarol is often found in the environment (coastal and harbour
waters). In Sweden it was detected in 80% of the samples + 50% in sludge of
WWTP in 2006, which demonstrates that there are other uses than antifouling.
A fact sheet has been circulated by SE on this issue.
 DS supports Sweden. In Germany, it is on the list to derive a national EQS and
there is evidence for various sources other than antifouling. DS adds it is
monitored as well in Switzerland.
 EV mentions a document produced in 2001 with Dutch EQS derived for this
substance.
 AL asks if it is listed as a biocide and JRR answers it is not in current Annex I
of Biocides Directive (98/8/EC) but intensive ongoing revision is in course.
 Conclusion: Irgarol is added to the list for dossier preparation.
-
Proposal (EEB) to include pharmaceuticals and endocrine disruptors in the
shortlist and to make a dossier:
 IJ cites different sources where such substances are indicated as to be
considered under WFD (see documents provided for the meeting)
 FI mentions it represents a large group of substances which include a big
diversity of effects, and this makes it complicated to include them as a group,
but FI supports this and indicates a lot of work was done on this subject in
Denmark, with EQS derived for some substances (ethenyl estradiol, etc.).
 DS asks if these substances were examined in the modeling-based prioritisation
and mentions Germany has prepared draft data sheets with EQS for 3
pharmaceuticals substances.
 Helen Wilkinson (HW) agrees pharmaceuticals are of interest. She says that
they are emerging with few monitoring and some of them went through the
modelling-based approach. She supports the need to look at them individually.
 Klaus Daginnus (KD) raises some of these substances went through the
modeling-based approach but there was not enough production volume data. He
ads that new data can help to look at them again and may make them rank
higher.
 EV mentions the EQS was derived in the Netherlands for 2 substances with
good confidence level but very low concentration, making them impossible to
measure with routine monitoring. Therefore re-running the modeling-based
approach with new production and use data would provide good complementary
evidence of risk.
11
 MCa agrees both groups are of concern and supports FI saying that groups of
substances are impossible to address through the prioritisation.
 NJ says it is difficult to handle such big and heterogeneous groups but is not
completely convinced that a compound by compound approach is the best way
out. Common biotic mechanisms are well known for some of them (even if
there might be unknown mechanisms as well). Maybe a way out is to deal with
these substances “sub-group by sub-group”.
 IJ mentions they are already recognized groups through some European projects
and adds many pharmaceuticals are used since a long time.
 JB proposes to ask CMA group, through the NORMAN network, to consider
this specific issue, because he does not see how to produce EQS for groups.
 JRR reports an overview about EC current work for the assessment of
pharmaceuticals. The authorisation process is lead by EMEA, but the
environmental assessment of this process was recognized as being weak in 2009
COM communication that sets objective to reduce the impact of medicines. DG
ENV and DG SANCO will work with EMEA to define actions. He also
mentions the community strategy on endocrine disruptors, included in REACH
and the PPP regulation. He concludes there is no need to put too much efforts
on these substances but suggests to prepare a dossier on the substances for
which information is already available from MS or KNAPPE project as a
starting point:
o DE volunteers to provide draft EQS data sheet on diclofenac,
carbamazepin, clarithromycin (81103-11-9), sulfamethoxazole (723-466), ibuprofen (15687-27-1)
o NL, DK and UK volunteer to provide information on ethnylestradiol
o FR volunteers to provide
pharmaceutical substances.
monitoring
information
on
some
o JRR stresses the importance to gather data from EU projects on the
subject (e.g. KNAPPE project) and share with NORMAN and the sub
group on chemical monitoring.
-
Proposal (SE) not to include 4 substances on the shortlist:
 NJ proposes to deselect from the shortlist substances with limited data available
and for which EQS derivation will not be possible anyway.
- # 334: Bifenox (or benzoic acid, 5-(2,4-dichlorophenoxy)-2-nitro-, methyl
ester;methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate) (CAS 42576-02-3),
according to EINECS there is low production volume
- # 57: Pentachlorobenzenethiol (CAS 133-49-3)
- # 346: paraffins (Paraffin waxes and Hydrocarbon waxes chlorinated) (CAS
63449-39-8)
- # 62: Cyclododecane (CAS 294-62-2)
 KD indicates they are ranked high through the modeling-based approach.
 Stefan SCHEUER (SS) adds that 3 of the 4 proposed substances are deemed to
be PBT substances.
-
Bifenox (CAS 42576-02-3)
12
 RD supports the need to have a good screening of substances before making the
dossier and says the reliability of EQS is itself a good screening to reduce the
number of selected substances and postpone the selection of some of them.
 HW supports the idea of making a dossier to effectively evaluate if no enough
data are available.
 Conclusion: agree to make a dossier for this substance
-
Paraffin waxes (CAS 63449-39-8) ranking high through modelling-based
approach
 Problem of correspondence between CAS and name (LCCPs are C18 and
higher)
 This substance is not a PBT.
 Conclusion: substance is “left for later”, need for clarifications. No dossier.
-
Pentachlorobenzenethiol (CAS 133-49-3) ranking high through modellingbased approach and is a PBT
 Dolf Van Wijk (DVW) says it is not produced in Europe.
 HW adds the only available information on the substance is that it is a PBT
(pers. comm. from ECHA)
 AL asks how it was possible to model it if no information on
production/producer are available?
 KD indicates the information was generated by industry, not ECHA, and
suggests this to be updated. Modelling was based on surrogate.
 DVW says it must be in HPV database if it has been treated by the PBT group,
and the conclusion is documented in the factsheet.
 Conclusion: deselected from the shortlist because no producer.
-
Cyclododecane (CAS 294-62-2)
 AD mentions this substance is a PBT but not a SVHC. It was taken off the list
of SVHC by ECHA. The information should be corrected (meeting 8th October
2008, see ECHA website).
 AV highlights this substance is a PBT, thus requiring a dossier.
 Conclusion: agree to make a dossier for this substance
-
Pesticides of interest for NL according to EV and DTH but not on the
shortlist:
 MH raises these pesticides are regulated and were included in the process,
including monitoring based, and not prioritized.
 FI, DS and RD support the view of EV and DTH.
 DTH adds more information are available than the one provided for the
monitoring-based approach. Moreover, “MAC approach” is not taken on board
by monitoring-based approach. DTH suggests compiling national lists and
selecting substances appearing in more than 3 countries.
 JRR says DG ENV understands it can be an issue for some MS that the
substances of concern for them are not on the list, but the issue of this
prioritisation process is not about sharing the lists. He reminds a questionnaire
was circulated in 2006 and the results are considered in the so-called Annex I
list (of substances candidate for the shortlist). A process has been run that gives
some results. It is worthwhile noting that NL has not provided monitoring data
13
for those substances they are asking for inclusion today, nor a ranking or other
relevant information to choose out of the 25 proposed substances, of which 9
are not on the shortlist. JRR adds that peak measurement of pesticides were
provided as convened at last meeting but no MS had the time to identify
substances on the basis of this information. This could have been a good
argument to suggest “new” substances for the shortlist.
 KDH, JB and KG support the view of DG ENV. We cannot re-run the process
now, and regional / local concerns need to be addressed at national level.
 FI raises the point that many countries feel concerned by these pesticides, but
we have to recognize that maybe we did not succeed in taking these pesticides
into account correctly
 MC and HW support Denmark, saying that MS lists are built using different
approaches and EQS derivation methodology is a different context. This has to
be a lesson-learnt for the next prioritisation exercise.
 RD adds that if the list has to be provided, the associated PNECs should be
provided as well.
SL briefly presents an information sheet on a project on hazardous substances in the Baltic
sea called Cohiba and invites experts to consult the website.
JB presents 4 pesticides that are:
-
Not ranking high according to the monitoring-based approach
-
Ranking 1 according to the modelling-based approach
-
Out of the Annex I of Directive 91/414/EEC
These pesticides are :
-
Dichlofluanid:
 not a candidate for “deselection” because the detection limit are above the
PNEC so it is difficult to conclude on a “no concern” even if the substance is
out of Annex I of Directive 91/414/EEC, i.e. not used
 Conclusion: Selected for a dossier
-
Methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate (bifenox, CAS 42576-02-3):
 It is selected through the modelling-based approach but not in 91/414
 Conclusion: Selected for a dossier
-
Ethalfluralin (55283-68-6)
 Is almost not used anymore in any EU MS, and will be out of the annex I in
2010 or 2011
 Conclusion: Deselected
-
Terbutryn (886-50-0)
 This substance is not allowed as a pesticide but still as a biocide
 Conclusion: Selected for a dossier
AL suggest to merge substances 111 and 172 that are isomers and sold together.
The work results in :
14
-
a list of 4 substances for which the EG-R will be waiting for information from
CEFIC + Dow Agroscience in order to conclude not to make a dossier.
Deadline is 17th February.
-
a short list of 40 substances, including 6 pharmaceutical substances for which
only a draft dossier will be prepared.
Deadline 26st March.
5.4. Distributions of dossiers among the Commission and Member States
JRR raises the timetable is tight and KG emphasises the inter-service and other related
COM procedures that also need to be considered, thus the first drafts for dossiers should be
ready by the 26th of March.
The list being finalised, with footnotes to emphasise some readily available information
exist to help drafting the dossier, the countries/NGOs that expressed their interest in being
involved in the dossier preparation are cited for confirmation or change. The results of this
are reported in the current minutes as Annex III.
Industries and NGOs volunteer to provide data for:
-
Eurochlor: chloro alkanes
-
CEFIC: Cyanides, EDTA, Bisphenol-A, (+maybe musk xylene, toluene,
cyclododecane, PFOS, HBCDD, octaBDE but need for confirmation)
-
CONCAWE: toluene and heptachlor whose production was ceased in 1988
-
ECPA: pesticides (trichlorfon, dicofol, tolyfluanid, AMPA, glyphosate, omethoate,
chlorothalonil, propiconazole, aclonifen, quinoxyfen)
-
EEB: all pharmaceutical compounds
-
IZA: zinc and its compounds
6. Next steps on the review and next meetings

3rd February: confirmation of offers for voluntary work on dossiers

17th February: provision of additional data by stakeholders for the substances
proposed for deletion of the list (aniline, piperazine, TAME and acrylic acid)

26th March: deliverable of dossiers

20-21th April: next EG-R
JRR reminds the overall objective is to decide on the final list of substances and to derive
EQSs, he proposes to add for each substance the contact point of the lead country and
upload on Circa the dossier template, the slides describing the content and the list of
substances with contact point.
AD asks for a detailed agenda for the next meeting for relevant sectors to participate.
EV asks for circulation of draft documents to the group before finalisation and JRR
reminds CIRCA website allows automatic alert for new documents.
AOB
AD asks if an impact assessment is foreseen in the process.
15
JRR answers it should start now, a contract was signed before Christmas and it will
accompany the final list. A first inter-service meeting is planned by the end of February.
JB and APP close the meeting and thank participants for their active involvement.
16
Annex 1
EUROPEAN COMMISSION
JOINT RESEARCH CENTRE
Institute for Health and Consumer Protection
Consumer Products Safety & Quality Unit
1 December 2009
SUB-GROUP ON REVIEW OF WFD PRIORITY SUBSTANCES LIST
DG ENVIRONMENT, ROOM C, AVENUE DE BEAULIEU 5, BRUSSELS
26-27 JANUARY 2010
DRAFT AGENDA
Start: Tuesday 26 January 10:00 h
End: Wednesday 27 January 18:00 h
Chairs: Ana PAYA-PEREZ (JRC-IHCP) and John BATTY (DEFRA, UK)
Item
1. Welcome and adoption of the Agenda
2. Introduction
 Outcome of WG E and Water Directors meeting
 Information on the state of play of the EQS Guidance
 Objectives of the meeting
Presentation
Chair
DG ENV
Presentation
Documents
 Draft minutes of the WGE October 2009
 Final synthesis of Water Directors meeting Malmö 30 Nov – 1
Dec 2009
 Final draft EQS guidance
3. Review of the results of monitoring-based prioritisation
IOW
Documents
 Information on quality and representativeness of monitoring
data
 Information on peak concentrations of pesticides
17
4. Results of the modelling-based prioritisation
JRC-IHCP
Documents
 Draft JRC report
 Results of the modelling-based prioritisation (document, excel
sheets and presentation)
5. List of candidates substances for prioritisation and identification
of the shortlist of 30-50 substances for dossier preparations
DG ENV
Presentation
5.1. Proposals and comments received on the list of candidate
substances since September 2009
Documents
 Version 5 of Annex I to Document WG-E(6)-09-03
 Overview of changes to Annex I and proposals and comments
received on the list of candidate substances
 Templates and information received on individual substances or
groups of substances
5.2. Identification of the 30-50 shortlist of substances to prepare
dossiers
Documents
 Approach to shortlist the list candidate substances
 Excel sheet with the extraction of PECs, PNECs and risk ratios
 Extract of conclusions and relevant tables from risk assessment
reports of chemicals, pesticides and biocides
5.3. Discussion on the proposal for a shortlist of 30-50 substances to
prepare dossiers
5.4. Distributions of dossiers among the Commission and Member
States.
Documents
 Overview of expressions of interest received and proposed way
forward
6. Next steps on the review and next meetings
DG ENV
DG ENV /
INERIS
DG ENV
DG ENV
18
Annex 2
List of participants
Expert Group on Review of WFD Priority Substances List
26-27 January 2010
Venue:
DG ENVIRONMENT, BU 5, Room 0C (26-27 January 2010)
Member States
Name
Manfred CLARA
County
Austria
Fleming INGERSLEV
Denmark
Susan Londesborough
Finland
Raphaël
DEMOULIERE
France
Dieter SCHUDOMA
Germany
Mario CARERE
Italy
Dorien
TEN Netherlands
HULSCHER
Eric VERBRUGGEN Netherlands
Concepcion
SANZ Spain
MARTIN
Niklas JOHANSSON
Sweden
Institution/e-mail address
Federal Environment Agency
e-mail
Manfred.clara@umweltbundesamt.at
Environment Protection Agency
e-mail address: fling@mst.dk
address:
susan.londesborough@ymparisto.fi
Tel: +358400148631
Ministère de l'Energie, de l'Ecologie, du
Développement Durable et de l'Aménagement du
Territoire
e-mail address:
Raphael.Demouliere@developpementdurable.gouv.fr
Federal Environment Agency
e-mail address: dieter.schudoma@uba.de
Ministry of the Environment and Land Protection
e-mail address: m.carere@iss.it
Water Management Partnership (RWS)
e-mail address: Dorien.ten.hulscher@rws.nl
National Institute for Public Health
Environment (RIVM)
e-mail address: eric.verbruggen@rivm.nl
e-mail address: csm@chduero.es
and
SWEDISH ENVIRONMENTAL PROTECTION
AGENCY
niklas.johansson@naturvardsverket.se
19
John BATTY
United Kingdom Department for Environment, Foods and Rural
Affaires (DEFRA)
e-mail address: John.Batty@defra.gsi.gov.uk
Helen WILKINSON
United Kingdom Environment Agency
e-mail address: helen.wilkinson@environmentagency.gov.uk
Stakeholders
Name
Organisation/e-mail address
Ann DIERCKX
European Chemical Industry Council (CEFIC)
e-mail address: ADI@cefic.be
André LECLOUX
European Chemical Industry Council (CEFIC)
e-mail address: envicat@skynet.be
Dolf VAN WIJK
European Chemical Industry Council - European ChlorAlkali industry (CEFIC - Euro Chlor)
e-mail address: dvw@cefic.be
Graeme WALLACE
European Chemical Industry Council (CEFIC - EFOA)
e-mail address: GWA@cefic.be
Alain CAVALLERO
European Chemical Industry Council (CEFIC)
e-mail address: aca@cefic.be
Klaas DEN HAAN
Oil Association (CONCAWE)
e-mail address: klaas.denhaan@concawe.org
Mick HAMER
Syngenta Crop Protection (ECPA)
e-mail address: mick.hamer@syngenta.com
Thierry SCHOONEJANS
ECPA –DOW
e-mail address: tschoonejans@dow.com
Richard ALLEN
ECPA – Bayer Cropscience
e-mail address: Richard.allen@bayercropscience.com
Frank VAN ASSCHE
International Zinc Association (IZA)
e-mail address: fvanassche@izaeurope.com
Katrien DELBEKE
European Cooper Institute (ECI)
e-mail address: kmd@eurocopper.org
Ismene JAEGER
European Environmental Bureau (EEB)
e-mail address: info@oekologischenetze.de
20
Stefan SCHEUER
Greenpeace
e-mail address: mail@stefanscheuer.eu
Ulrich BORCHERS
SEW
e-mail address: u.borchers@iww-online.de
European Commission
Name
Institution/e-mail address
Ana PAYA PEREZ
JRC-IHCP, I2
e-mail address: Ana.PAYA-PEREZ@ec.europa.eu
Jose ZALDIVAR
COMENGES
JRC-IHCP,
e-mail address: jose.zaldivar-comenges@jrc.ec.europa.eu
Jorge RODRIGUEZ
ROMERO
DG ENV, D1
e-mail
address:
Jorge.RODRIGUEZROMERO@ec.europa.eu
DG ENV, D1
e-mail address: Madalina.DAVID@ec.europa.eu
Madalina DAVID
Helen CLAYTON
Karola GRODZKI
DG ENV, D1
e-mail address: helen.clayton@ec.europa.eu
DG ENTR, G2
e-mail address: Karola.GRODZKI@ec.europa.eu
Alice JAMES
Consultant – INERIS
e-mail address: alice.james@ineris.fr
Benoît FRIBOURG-BLANC
Consultant – Office International de l’Eau/International
Office for Water (OIEau/IOWater)
e-mail address: b.fribourg-blanc@oieau.fr
Klaus DAGINNUS
e-mail address: kdaginnus@web.de
21
Annex 3
PREPARATION OF DOSSIERS
Lead
Associated
stakeholders
52-68-6 Trichlorfon
FR
ES, ECPA
57-12-5 Cyanides
COM
NL, CEFIC
10
60-00-4 Edetic acid (EDTA)
COM
NL, CEFIC
12
62-53-3 Aniline
FR
13
62-73-7 Dichlorvos
COM
20
76-44-8 Heptachlor
#
CAS # Substances
1
7
MS/
DE
COM
75
1024-57-3 Heptachlor epoxide
22
79-10-7 Acrylic acid
26
80-05-7
Bisphenol
A
isopropylidenediphenol)
28
81-15-2
Musk xylene (5-tert-buthyl-2,4,5AT
trinitro-m-xylene)
(4,4'-
UK
CEFIC (PLASTICS
EUROPE)
NL, CEFIC?
UK, FR, IT, NL,
CEFIC?,
CONCAWE
43
108-88-3 Toluene
46
110-85-0 Piperazine
47
115-32-2 Dicofol
57
133-49-3 Pentachlorobenzenethiol
62
294-62-2 Cyclododecane
SE?
COM, CEFIC?
71
731-27-1 Tolylfluanid
FI
AT, ECPA
74
994-05-8 2-methoxy-2-methylbutane (TAME)
FI
DK
COM
76
1461-25-2 Tetrabutyltin compounds
77
1066-51-9
Amino-methyl
(AMPA)**
phophonic
NL
acid
FR
NL, ECPA
22
#
CAS # Substances
Lead
Associated
stakeholders
MS/
78
1071-83-6 Glyphosate**
FR
NL, UK, ECPA
79
1113-02-6 Omethoate
COM
ECPA
89
1333-82-0 Chromium trioxide
UK
FR,
EUROMETAUX
90
1336-36-3 Polychlorinated biphenyls (PCBs)
FR
SE, IT, NL
92
1634-04-4 Tert-butyl methyl ether (MTBE)
FI (DK)
96
1746-01-6
98
Perfluorooctane sulfonic acid and its
1763-23-1 salts (PFOS) and perfluorooctane UK
sulfonyl fluoride
Dioxin (2,3,7,8 - Tetrachlorodibenzo-p
SE, IT
dioxin,TCDD)
100
1861-40-1 Benfluralin
101
1897-45-6 chlorothalonil
111
3194-55-6
172
25637-99-4
SE, NL, IT, DE,
CEFIC (PLASTICS
EUROPE)?
COM
NL, ECPA
SE
AT, CEFIC
UK
FR
UK
FR,
NL,
EUROMETAUX
IT
FR
1,2,5,6,9,10Hexabromocyclododecane (HBCDD)
1,3,5,7,9,11Hexabromocyclododecane (HBCDD)
114
5598-13-0 Chlorpyrifos-methyl
116
7085-19-0 Mecoprop (MCPP)
121
7440-50-8 Copper and its compounds
124
7440-66-6 Zinc and its compounds
171
25057-89-0 Bentazon
176
32536-52-0
196
52315-07-8 zeta-Cypermethrin
COM
NL
204
60207-90-1 Propiconazole
DE
ECPA
214
74070-46-5 Aclonifen
COM
ECPA
Diphenyl ether, octabromo derivative
SE
(octoBDE or BDE-197)
CEFIC?
23
#
224
CAS # Substances
85535-85-9 Alkanes, C14-17, chloro
Lead
Associated
stakeholders
UK
CEFIC
(EUROCHLOR)
ECPA
253
124495-18-7 Quinoxyfen
COM
288
2303-17-5 Tri-allate
UK?
309
1085-98-9 Dichlofluanide
COM
2,2',6,6'-tetra-tert-butyl-4,4'methylenediphenol
312
118-82-1
334
42576-02-3
339
55283-68-6 ethalfluralin
346
Paraffin waxes and Hydrocarbon
waxes chlorinated;paraffin waxes and
63449-39-8 hydrocarbon
waxes,
chlorinated;Paraffin
waxes
and
Hydrocarbon waxes, chloro
AT
methyl
5-(2,4-dichlorophenoxy)-2COM
nitrobenzoate
350
7287-19-6 prometryn
353
834-12-8 ametryn
355
886-50-0 terbutryn
DE
367
28159-98-0 Irgarol
SE
NL, DE
377
15307-79-6 Diclofenac1
DE
EEB
372
298-46-4 Carbamazepin1
DE
EEB
373
723-46-6 Sulfamethoxazole1
DE
EEB
384
81103-11-9 Clarithromycin1
DE
EEB
378
15687-27-1 Ibuprofen1
DE
EEB
NL
DK, UK, EEB
17alpha-ethinylestradiol
387
17 alpha/beta estradiol1
1
For these substances a draft dossier will be prepared by the lead and associated countries
and pass it on to the CMEP Sub-Group for completion.
24
MS/