EUROPEAN COMMISSION
DIRECTORATE-GENERAL
ENVIRONMENT
Directorate D - Water, Chemicals & Biotechnology
ENV.D.1 - Water
12 October 2009
EXPERT GROUP ON REVIEW OF WFD PRIORITY SUBSTANCES LIST (EG-R)
SUB-GROUP OF THE WORKING GROUP E ON PRIORITY SUBSTANCES
DG ENVIRONMENT, 21-22 SEPTEMBER 2009
Minutes
Participants: Jorge RODRIGUEZ ROMERO (JRR), Madalina DAVID (MaD), Karola
GRODZKI (KG), Steven EISENREICH (SE), Ana PAYA PEREZ (APP), Klaus
DAGINNUS (KD), Sandrine ANDRES (SA), Alice JAMES (AJ), Benoît FRIBOURGBLANC (BFB), John BATTY (JB), Helen WILKINSON (HW), Raphaël DEMOULIERE
(RD), Marc BABUT (MB), Mélissa DALLET (MeD), Petra RINGELTAUBE (PR), Mario
CARERE (MC), Theodora TEN HULSCHER (DH), Eric VERBRUGGEN (EV), Helene
LAGER (HL), Henning CLAUSEN (HC), Ismene JAEGER (IJ), Nadia HAIAMA (NH),
Ann DIERCKX (AD), Andre LECLOUX (AL), Katrien DELBEKE (KaD), Frank VAN
ASSCHE (FvA), Klaas DEN HAAN (KdH), Mick HAMER - Syngenta (MH), Dolf VAN
WIJK - Euro Chlor (DvW).
First day of the meeting: 21 September 2009
1. Welcome and adoption of the Agenda
Ana Paya Perez (APP) and John Batty (JB) welcomed the participants and invited them to
introduce themselves in a round table (see List of participants attached in Annex 2).
APP introduced the main objectives of the meeting. 1st day of the meeting was planned to
be devoted to the review of the WFD priority substances list including discussion on the
overall prioritisation process, the mandate of the Expert Group on Review (EG-R), the
template with data sheet for candidate substances, the results of modelling-based
prioritisation, screening criteria to be used to score Annex 1 substances and the next steps
of the review.
JB pointed out that meeting should consider prioritisation at a strategical level and not go
into details and therefore the focus for these days is to find a robust system on prioritisation
and to agree on the criteria for de-selection to be used for long-term purpose.
1
APP continued with the topics intended to be addressed on the 2nd day of the meeting as
the Draft Technical Guidance Document on EQS derivation (TGD-EQS), results of testing
phase of the guidelines and how/if these are going to be used to amend the methodology
proposed, next steps to finalise the TGD-EQS and what to be presented to the next WG E.
As regards the Draft Agenda (attached in Annex 1), APP reminded to the members that this
was distributed before the meeting and she ask for comments and possible points to be
added.
Henning Clausen (HC) suggested adding, if possible under agenda AOB, the link between
all databases on existing EQSs established at national level by different Member States.
Theodora Ten Hulscher (DH) asked for clarifications on agenda item 2 and 3 having in
view that this looked, in her opinion, a repetition of a single statement.
Jorge Rodriguez Romero (JRR) clarified that point 2 is an overview of main requirements
under different pieces of legislations that need to be considered during prioritisation
process and then under point 3, the EG will discuss and agree the work programme,
responsibilities and timetable.
DH asked whether the time schedule should not be discussed first?
JRR responded that this was planned to be addressed at the end of today day, but could be
moved if the EG-R will agree.
No further comments were received and APP concluded that the Agenda was adopted with
one addition to the Agenda under item AOB as suggested by Denmark and possible
discussion on timetable earlier than initially foreseen.
2. Presentation of the document WGE(6)-09/03 on overall prioritisation process
JRR presented the content and purpose of the document WGE(6)-09/03 (see slides and
document on CIRCA).
On the purpose, JRR introduced the possible elements to be considered for the review of
priority substances purpose and the principles of prioritisation as derived from Article
16(2) of the WFD identifying also other possible sources of substances. JRR emphasized
that these sources aimed at possible covering of as many as possible substances despite of
the fact that at end some overlaps may occur. JRR stressed that the scope of collection of
all available information was to establish a list of possible candidate for the list of priority
substances (Annex 1 of the document WGE(6)-09/03) to be review and decided as final list
by the EG-R. At the end of his presentation JRR presented a tentative timetable for the
finalisation of the review. JRR concluded that the outcomes of this review are fundamental
for the future Commission’s proposal. JRR indicated that the discussions are likely to focus
for the first meeting on general consideration and not on specific substances.
APP invited any comments or questions from the floor.
Andre Lecloux (AL) asked why Annex III substances are added in Annex 1 as long these
are already included on the list of universe of chemicals for modelling-based prioritisation.
Klaus Daginnus (KD) pointed out that the scope of Annex 1 is to integrate all information
available, including the results from monitoring modelling approach. JRR said that the
Commission has a specific mandate to review Annex III substances and therefore they
appear in Annex I list. The final report on prioritisation should contain justification on the
reasons these substances have or have not been prioritised.
Raphaël Demouliere (RD) commented that proceeding in this way, substances would be
revised/included twice in the process of prioritisation. APP replied that the strategy of
prioritisation includes all the regulatory legislations adopted at European level and/or under
2
relevant international agreements. Also, APP mentioned that the mandate of EG-R is to
discuss the potential inclusion or non-inclusion of some substances on the list of priority
substances. JB underlined that Annex 2 of document WGE(6)-09/03 includes other sources
(as tiers) in addition to the requirements of Article 16 of the WFD (the last two tiers on top
left) and the role of the EG-R is to bring into discussions all the available information. Eric
Verbruggen (EV) agreed, in principle, with what was previously said, but he points out that
the procedure applied under the risk assessment on existing substances registered (ESR) is
not the same as, for instance, the one applied for the risk assessment on pesticide and this
should be taken into account as the methodology used for risk assessment of pesticides may
not be appropriate for the WFD prioritisation.
Nadia Haiama (NH) asked where will be discussed the control measures?
JRR replied that this is not a task of the EG-R for the moment. Later on in the process the
WG E on Priority substances will have to decide how discussion on control measures is
taken forward.
AL asked how the potential endocrine disrupting effect will be further considered, taking
into consideration the Weybridge definition that to be classified as an endocrine disruptor,
an adverse effect needs to be shown.
DH stated that it cannot be decided how to regulate all the substances and all the
compartments where these substances could be analysed. JB agreed with DH and moreover
these uncertainties should be pointed out.
APP suggested moving further to the next agenda point to get more clarity on the whole
process to be applied.
3. Mandate of the Expert Group on Review
JRR gave a presentation on the mandate of EG-R and the proposed working methods (see
slides on CIRCA). JRR completed the presentation with some questions to be responded by
the EG-R.
APP invited any comments or questions from the floor as well as to respond to the
questions raised. APP continued that probably is too early to reply to these questions and
therefore she suggested discussing first the proposed steps. JRR stressed that the point to
be addressed now is on how to move further the work developed.
Ismene JAEGER (IJ) requested some clarification on the next steps.
EV commented that there are some errors on the list in the Annex 1 that have to be
carefully checked (e.g. on PBT).
RD did not agreed with these comments as long as we discussed already during May
Workshop on prioritisation that a comparison between the results of modelling approach
and monitoring approach is needed.
AL and Ann DIERCKX (AD) recalled that new substances are going be included in Annex
1 and the way to go forward is not clear. For example, is it planned to run again the two
prioritisation processes for these new substances or will they be added directly on the
candidate list of substances?
DH stressed that the merging the lists is required as well the establishment of de-selection
criteria. JRR agreed with DH, but the idea on how to combine the information coming
from different lists remains an open issue to be discussed by the EG-R.
JB suggested that now is the time to agree on the deadline for addition of new substances.
Once agreed, these substances will be part of waiting list that will be used for the next
review. JB concluded that this is a pragmatic solution and it is essential that this is clearly
3
understood. NH supports JB view, the list with substances not very highly or highly ranked
should be made publicly available.
Helen WILKINSON (HW) pointed out that will be useful to know which substances are
ranked through different methodologies and the scores attributed to them.
RD proposed to change the cross from the column related to the results of monitoringbased ranking with scores.
DH pointed out that it can happen to have different scores for the 2 methodologies and
consequently it is important to find a solution to cope with this. JRR responded that this is
the task of EG-R, so the issue has to be sorted out by this group.
JRR he underlined that is not possible to map everything out and that a case by case
analysis of substances is necessary.
EV reiterated that is fundamentally to establish how the two lists will be merged and thus
we have to weight the conclusions coming from the 2 methodologies.
Klaas den Haan (KdH) recalled that monitoring results are supposed to be used for
modelling results checking. JB agreed in principle with KdH, but he also stressed that we
must be careful because there is a time lapse between the two processes and so, we have to
find a mechanism on how to merge these different strains.
EV said that if you have a substance ranked high it is needed to check related monitoring
data. KdH continued that in this respect monitoring data should not be neglected. EV
agreed, but at the end you have to decide how to weight the outcomes of the two
approaches.
JRR concluded that a new point could be added to the proposed steps on discussion and
agreement of the weight of different results.
NH asked about the timeline for the proposed step. JRR responded that a tentative
timetable was given in document WGE(6)-09/03, but should be re-discussed and detailed
at the end of the day.
APP concluded that the EG-R agreed on the approach for the proposed steps.
1. Finalise modelling-based approach and fill in the information in list of candidate
substances
→ Agenda point 6
2. Agree screening criteria to shrink the list from ~300 to a manageable number (30-50?)
→ Agenda point 5
3. Prepare dossiers for all substances remaining on the candidate list, to be used as a
basis for substance specific discussions
→ Agenda point 4
4. Finalise EQS derivation for those substances selected
Each step to be overlooked by WGE
DH commented that Members States do not have the necessary resources to work on the
preparation of the dossiers for different substances. JRR responded that Member States
worked already on this issue and available information could be provided if exists. HC
agreed in principle with JRR, but Member States will be in a better position to make any
statements when the list of candidate substances will be completed.
AL asked whether there is planned to involve also the stakeholders in the preparation of a
dossier for a specific substances?
JB stressed that it may be sensible to review dossiers provided by the Member States and
for this purpose EG-R could contribute. However, JB emphasised that the standard setting
process could also be an expensive one. Anyway, the costs could be reduced if the synergy
with previous work is taking into account.
4
JRR concluded that the list is going to be completed soon and therefore Member States
would be able to provide information on substances that they worked on and to share the
work with other Member States as well as with interested stakeholders.
AD asked whether EQSs for existing priority substances and priority hazardous substances
are going to be reviewed or re-visited. EV supported AD point of view saying that EG-R
would be appropriate to review the EQSs for existing priority substances and priority
hazardous substances. JRR responded that this issue is also planned to be done, but is not
yet included in the EG-R mandate.
As regards the EQSs derivation for those substances selected, APP said that EG-R would
analyse this issue on case by case basis.
On possible addition of new substances on the Annex 1 list, APP suggested addressing this
with the WG E on priority substances, but anyway a strict deadline should be clearly
settled.
In conclusion, APP said that EG-R agreed with the principles underlined in WGE(6)-09/03
document and proposed mandate and working methods for the group.
4. Review of the results of monitoring-based prioritisations
4.3. Proposals for testing of quality and representativeness of monitoring data and for
presentation of results
Benoît FRIBOURG-BLANC (BFB) informed EG-R members about the website on priority
substances database created for the purpose of this review as well as about the summary
information available for each substance that could be directly downloaded as pdf
documents (see slides on CIRCA). On the second part of his presentation, BFB presented a
proposal for further testing of quality and representativeness of monitoring data. Also,
some examples were used for better understanding of this proposal.
APP invited any comments or questions from the floor.
JRR took the floor giving more explanations on what was meant by these graphs. JRR
continued that this is intended to complement the existing information on “a posteriori
checks” that have been already provided in the Report on monitoring-based prioritisation.
These types of graphs will offer a visual information (and therefore quicker to get it) on the
weight of quantified values in relation with PEC1 and on number of values below the limit
of determination that contribute to PEC2 as well as how these results relate with PNEC.
DH commented that 2 substances were given as examples for two different matrices and
therefore is difficult to understand what the conclusion is. BFB responded that these are
only some examples of the assessments that could be useful for the further work on the
review of Annex 1 substances and the intention was to present these possibilities to the EG
and to trigger the discussions on whether these help or not/need to be
improved/supplemented, etc.
In addition to that, other queries were triggered by BFB presentation as follows:
- DH noticed that for instance limit of determination in the graph for PCB vary
considerable.
- AL said that having in view the meaning of PEC1 and PEC2, it would be useful to have
such both distributions on the same graph
- Petra Ringeltaube (PR): both are for water phase or water and sediment; could be the
quality estimated by this way? What about coastal waters?
- AD asked whether the location of the stations identified based on these types of graphs
could be mentioned? This information will help the quality checks.
- Mario Carere (MC) asked whether DL means determination limit or detection limit?
5
JB summarised that the huge dataset compiled from the EU collection exercise represented
a massive step forward but that it was still not possible to confirm that these are all routine
monitoring data or include other types of monitoring data. Anyway, the group should take
full advantage of the available information. It is obviously that analytical quality is going to
be improved but, for the time being, we have to take the most robust data that we have at
this stage.
KD underlined that modelling information are going to support those coming from
monitoring; for e.g. this substances is banned, so could be a historical pollution problem.
Katrien Delbeke (KaD) considers this information as very good. She asked whether either
detection limits or quantification limits of measured values could be made available? She
also proposed to have an indication of the departure of the quantified values in relation to
the limit of determination.
BFB clarified that the meaning of limit of determination is what is explained in the INERIS
report.
JRR concluded that the type of graph proposed is useful. Also, JRR noticed that two
proposals were made: one is to develop an indicator of how far the quantified values are
from the limit of determination. The second is to investigate the geographical
representativeness of the quantified results. However, the second proposal could be
sensitive for the Member States, so it could be decided at a later stage if is really needed.
APP concluded that EG-R members considered this proposal as being very useful. Further
considerations/improvements are needed as suggested.
4.4 Draft Template for substance data sheet
Alice JAMES (AJ) gave an oral presentation on the content proposed for the substances
data sheet template (see document on CIRCA).
APP invited any comments or questions from the floor.
EG-R members asked for clarifications and/or provided comments/suggestions. In general,
these were related to the facts that:
- background documents used should be mentioned (CH, EV);
- EQS should be justified in a larger dossier, including COMMPS database (AL); e.g. HC
said that in Denmark, an extensive database is put as an Annex and summary data sheets
are used, but HC is in favour of having an extensive document. This idea was also
supported by EV. The template as is stands now could be useful summary information, but
not enough for EQSs derivation.
- information on raw data and the way of data processing are needed (JB);
- information on toxicity should be more detailed (HW);
Apart from these, the group gave its input on concrete information that is needed to
supplement the existing ones. The followings suggestions were made:
- add dataset to the section 8 (FvA);
- add a new point on residual uncertainties under section 8 (DH and EV);
- add "other species" in the table of section 7.1. (KdH);
- move section 6.1 “Estimated concentrations” to chapter 5 “Environmental behaviour”.
(Mick Hamer (MH)).
JRR clarified that initially the intention was to discuss if this template could be used for
prioritisation (pre-selection of substances). For this first step sections 3 and 8 would be
empty or not fully completed. If a decision is taken to develop an EQS for a particular
substance, the data sheet can then be further developed for this purpose. Current template
was used by INERIS to test the TGD-EQS and the results of tests made for a number of
substances were made available to the group.
6
DH commented that also for prioritisation purpose we need some kind of tentative EQSs
(like PNECs values).
FvA said that registration under REACH Regulation generates a lot of new information, for
instance risk information and therefore will be worthwhile to know how these will be
incorporated? APP responded that these data are not yet accessible and probably will not be
taken into account due to time constrains of the review process. JRR added that is not
possible to receive these information from ECHA in such a short while and therefore EG
members (especially stakeholders) are asked to provide relevant available data. The first
registration process under REACH will finish by the end of 2010 and therefore this is too
late.
AD requested clarifications whether all the studies/reports sent by different MS and
stakeholders could be considered for this purpose? JRR replied affirmatively.
HC asked if such kind of tentative EQSs should be derived also for sediment and biota
compartments? DH answered that probably not for all substances and to be assessed caseby case.
APP suggested adding the template as an appendix to the TGD-EQS as it is more
comprehensive than the one in the current draft.  Action to implement by the rapporteurs
and the editor of the EQS Guidance
A new version of the template will be produced by INERIS taken into account the
comments made at the meeting.
4.2 Overview of comments on monitoring-based the ranking
AJ presented to the EG-R members a number of comments for which their expert advice is
requested (see on CIRCA the slides as well as the documents on the overview of comments
and the report on monitoring-based prioritisation).
APP invited any comments or questions from the floor.
On the comments received on false negatives - issues on monitoring practice/performance,
EV agreed that substances not usually monitored might be covered by the modelling
approach; this should be checked when the results of modelling-based prioritisation will be
made available. JRR pointed out that any prioritisation methodology has advantages and
disadvantages and that is why complementary methodologies based on monitoring and on
modelling are developed in parallel. KD intervened confirming that emerging substances
were included in the universe of chemicals for modelling-based approach. Also, some data
from NORMAN project were used, but it has to be underlined that the quality of these data
does not have the same level as those provided by the Member States for the monitoringbased ranking. KD continued that some pharmaceuticals are more likely to be added, if
additional information could be made available.
DH stressed that some substances of concern could be easily missed and therefore we have
to give a special attention to this step of "selection of manageable substances". JRR agreed
with DH view, and agreed that the list of candidate substances should be maintained open
until a deadline in order to allow for further substances to be added provided the evidence
and data is provided.
On the comments received on false negatives - issues on monitoring peak concentrations,
KD emphasized that in case of modelling approach Join Danube Survey (JDS) data were
incorporated.
DH suggested that a possibility to take into consideration these discontinuous emissions
patterns is to use both types of values MAC and AA, if available. AL not fully agreed
having in view that in such cases accidental spills will be included. JB commented that this
is difficult to judge; one example is seasonal fluctuation, so at the end could be also a
combination of all aspects. JRR specified that current methodology is not addressing this
7
issue and it has to be agreed within the group if it is needed. MH replied that this is not
needed; pursuant to Pesticides Directive requirements, mitigation measures are required for
active substances posing risk to aquatic environment.
On the comments received on persistency and bioaccumulation criteria, APP specified that
these are covered by modelling-based methodology. EV disagreed with this approach.
According to his opinion, PBT criteria are clearly established in REACH Regulation, but
application of modelling for P, B and T is in contradiction with. KD and Dolf van Wijk
(DvW) opposed to that explaining that reliable model were special created for PBTs and
POPs assessment; DvW will send the web link were this information could be found. 1
On the comments received on the use of sediment and biota monitoring data for risk
ranking, EV argued that human health is the critical root for these types of substances and
therefore PNECwater must include also the indirect toxicity as secondary poisoning and
human health. JRR agreed this is an important route. Secondary poisoning was included
indirectly in COMMPS. In case of INERIS approach, this is included directly using
sediment and biota data. The drawback is that there are substances for which there is no or
very little monitoring information in these matrices. Therefore, there is a risk of
underestimation that should be looked at on a case by case basis. DH suggested giving
different prioritisation weights to each compartment. APP stated that even there are few
data on sediment and biota, these have to be carefully considered.
The proposed way forward on the comments received on the use of equilibrium partitioning
approach to calculate PNECsed was generally supported.
5. Comments received on document WGE(6)-09/03
5.1 Annex 1 to Review of the WFD Priority Substances List
JRR gave a presentation on Annex 1, which contains the list of candidate substances and
Commission’s proposal on screening criteria (see on CIRCA the slides as well the
documents on Annex I and overview of the comments on the overall prioritisation process).
JRR ended his presentation addressing few questions to the EG in order to trigger further
discussions.
1. Proposal on the screening criteria for pesticide/biocide (as proposed in the document
WGE(6)-09/03)
Main concerns of the EG are summarised further below as being related to the following:
- Why CMR substances are not included in Annex 1 substances? (HC)
- Weights to be done to monitoring data coming from existing database and old database
related to the RARs that could be for example 10 years old (FvA). MH stressed that this is
important having in view that for instance pesticide registration is related to the field and
not to the water bodies as requested by the WFD.
MH considered this criterion as reasonably good. EV not agreed with the exclusion of
active substances, which are actually Annex I substances of Pesticide Directive, even if
there are no other evidences as monitoring data or modelling data. DH supported the idea
and on her opinion different approach should be applied, for instance these substances
could be put at the end of the candidate list instead of excluding them. EV said that the
1
This is already done. DvW provided the reference to a paper submitted to SETAC Journal received
http://www.setacjournals.org/perlserv/?request=get-toc&issn=1551-3793&volume=5&issue=4, (pages 535
and onwards).
8
assessment used under Pesticide Directive would not be appropriate for prioritisation
purpose under the WFD. The goals of the two directives are different and therefore the
results may considerable differ at the end. The Netherlands made this comparison for 27
pesticides that were analysed based on Pesticide Directive (selection of Annex I
substances) and EQS Directive procedure. These results could be made available to the
group. 2
RD asked for clarifications on comparison made; in case of pesticides is MAC/AA versus
what?
MH replied that peak concentration is used for exposure assessment of pesticide.
JRR stated that the Commission does not have the necessary resources to investigate the
MAC levels for the 176 pesticide that are included till now in Annex 1 as possible
candidate substances. However, maximum monitored values could made available to be
looked at if this is the willingness of the EG. KD underlined that modelling approach
provided this type of information for some pesticide included in the universe of chemicals,
but unfortunately not more information are available till now.
JRR concluded that EG agreed with the screening criteria proposed by the Commission. As
regards the maximum values found in the monitoring data, the Commission will find a
solution on the presentation form and will provide this information to the EG.
2. Proposal on the local risk as referred to the document WGE(6)-09/03
JRR proposed to look at each of the RAR for ESR and to identify if the risk conclusion
was drawn due to local problems or EU wide spread contamination. KD supported the
approach having in view that IUCLID database used for modelling approach did not help
much. However, this is not an easy process in term of time allocated to read long files as
RARs. In addition to that, the conclusion is sometime not so evident.
Karola Grodzki (KG) agreed with the idea. Anyway this is the best what could be done.
Other options like contacting the rapporteurs for the RARs are not feasible.
EV emphasized that German comments are valuable. Discharges via public sewers may
cause problems throughout the Europe and therefore the problem should be carefully
investigated.
JRR closed the discussions and concluded that DG ENV with JRC will look at the risk
assessment reports and will share the findings with the EG-R.
3. Proposal on the representativeness of monitoring database
DH suggested that even if there is little information on sediment and biota monitoring these
should not be disregarded. A possibility to check the wide spread is to combine monitoring
and modelling information.
EV commented that de-selection of candidate substances due to number of countries
criterion have to be done only in the situation when these substances are also included in
modelling-based prioritisation methodology. KD clarified that all substances form
manageable list used for monitoring approach are included in the universe of chemicals for
modelling approach.
FvA reiterated the idea that different weights have to be granted to monitoring data coming
from existing database and those coming from old database (RAR).
2
This is already done. Report sent by EV e-mail on 29/09/2009 and is available on CIRCA under "Other
relevant documents" folder.
9
KaD suggested that another possibility to check the representativeness is look at the
background concentrations for natural occurring substances (e.g. FOREGS database). FvA
supported this idea as long as background concentrations are related to the local geology.
EV considered the idea as being good for comparison but not as a criterion for de-selection
of certain substances; on the other hand background concentrations are already part of
BLM. HC considered that if the risk to aquatic environment was already identified,
background concentrations become useless.
FvA said that are only few substances that are normally affected by background
concentrations.
AD requested more clarifications on screening or de-selection criteria for the remaining
substances; obviously with the agreed criteria we are far from the targeted number.
RD and JB proposed to assess/identify the uncertainties associated with both monitoring
and modelling approaches when PEC and PNEC values are determined.
KD pointed out that is not an absolute need to establish de-selection criteria. For instance
you can simply use PEC/PNEC or PEC values considered by modelling and monitoring
methodology.
APP concluded that according to the discussions, the EG-R favours the development of a
ranking, more than a de-selection process.
APP closed the meeting and thanked EG members for their active participation.
10
Second day of the meeting: 22 September 2009
APP informed the EG about the programme of the day: continue the discussions on
prioritisation of substances, in particular based on modelling approach; the agreement of
the next steps of the review; the TGD-EQS; testing phase of the guidance and identification
of the open issue to be addressed to the WG E.
6. State of play and outlook of modelling-based prioritisation
KD gave a presentation on the state of play and outlook of modelling based prioritisation
(see final list of universe of chemicals for modelling and presentations on CIRCA). Based
on the proposals received from Member States and/or stakeholders, a new list of the
universe of 2034 chemicals was established. As agreed at May meeting by the sub-group
on prioritisation, the methods and tools to estimate the hazard and exposure scoring were
applied. A list of 79 substances was identified as having risk ranking score 1. In summary,
the actions left to be done in the near future, if the group will agree with, are: possible
extension of list of candidates with substances with score 2, evaluation of uncertainties
(EG review), implementation of vP and vPvB assessment, calculation of PEC/PNEC
values based on ECETOC TRA tool.
APP invited any comments or questions from the floor.
KG asked for clarifications on the use of SPIN database for production volumes and uses
indices and how AF=10 was chosen. KD explained that SPIN database was agreed to be
use as reliable source of information. As regards AF=10, this is disputable and was chosen
based on the relationship between the population of Scandinavian countries and the whole
of Europe.
MH underlined that Footprint is a limited database. KD agreed, but on the other hand there
are only few available databases to extract exposure data; if ECPA agrees with, PNEC data
could be collected from their database.
DvW asked clarification in relation with PBTs selection having in view that some of them
are hydrophobic substances. KD replied that 27 substances selected as PBTs are with real
concern to aquatic environment.
EV suggested that will be good to know what are the differences between TRA tool and
RARs approach with respect to estimation used when exposure and hazard was assessed as
well as when PEC and PNEC values were calculated. KD replied that this is not relevant as
long as TRA tool could be used either for substances for which any kind of information are
available (like RA, monitoring data, other kind of info) or for unknown substances.
APP concluded that the EG is now aware about the overall process of review of substances
and about the details of all the steps applied till now for this purpose as well as about the
fact that this group was appointed to review the results and to make proposals on which
substances could become candidate priority substances. Based on the outcomes of the work
developed by the EG-R and further discussions at the WGE, the Commission will prepare a
report that will be the basis for the new Commission’s proposal for the review of WFD
priority substances list.
APP continued that now we have to merge the two lists coming from the two
methodologies (modelling and monitoring). In addition, JRR recalled that also COMMPS
methodology, used for the establishment of the initial list of priority substances, identified
substances from both monitoring and modelling sides; modelling results are meant to
complement the monitoring methodology.
11
JRR emphasized that at this stage is important to discuss and agree the weight to be given
to different strains in order to move further. Annex 1 contains a long list with substances
that need to be shorted and then to move to the next step of preparation of detailed
information. In consequence, at this stage, the list coming from modelling based
prioritisation could be taken and added to Annex 1.
The discussions were focused on what else is needed before to move to the next step of the
process. EG-R members were invited to give their opinion and these are summarised
further below:
- screening criteria for modelling approach were not yet agreed (AL); yesterday we
discussed only the screening criteria for monitoring approach;
- proceed to do reality checks as agreed in May meeting (DH);
- discuss on uncertainties (DH).
KD underlined that proposed actions could have as result loosing a lot of substances
introduced by the modelling approach.
EV suggested that QSAR could be used to provide reliable date, thus could help to identify
the uncertainties.
JRR pointed out that both results from modelling and monitoring could be together
analysed and review, but important is to agree the starting point; for instance, the list of
substances raked with score 1 (79 substances) is acceptable as good result of modelling
approach? KD replied that on his opinion this is ready and then in order to give weights of
these results and to make them comparable with monitoring results we need to apply TRA
(calculate the risk ratio).
AD said that such a check for substances as e.g. endocrine disruptors is needed. Is the high
score justified given that the starting point is a list of potential EDs? KD replied that this is
also the case of substances considered as possible PBT, but this information could be easily
obtained and could be done also in parallel with what was previously proposed; these types
of checks will not for instance jeopardise de-selection criteria step. DvW and KG said that
they are not in favour of merging of the two lists till a reality check for modelling results is
not done having in view that this will help to understand whether the two lists could fit
together. KD stressed that a critical issue is the timing. A choice can be made to weight
more monitoring results than modelling data; the feasibility should be discussed only in
respect of timing.
JRR agreed that the calendar of the new proposal is settled in the EQS Directive and have
to be fulfilled and thus we have to have a clear and well-organised strategy on what is
needed, how long it takes and by whom is done. In short, what is urgent now: to shorten the
list and to develop substances datasheets identifying the key data and the uncertainties.
Modelling ranking should be completed applying TRA tool and then the results of
modelling will be integrated in Annex 1. Afterwards, we will need to discuss on the how to
weight the results and on how to extract 20-30 substances for which we need to prepare the
dossiers.
DH said that reality check is needed to look at investigative monitoring as provided by
NORMAN network or other research projects/studies. KD agreed. This information should
be used, but there is one condition “if available”.
KD proposed that checks to be done only for the substances for which RARs are not
available. This was not supported by EV. EV said that if the results of RAR are used is the
same as adding substances directly on the list of candidate, but this is not happen with
other substances for which data do not exists. KD replied that we have to remind what the
purpose of this exercise and priorities are; for instance recalculation of PEC and PNEC
values will imply additional work because new information should be collected.
12
7. Next steps on the review
JRR introduced to the group a proposal for next steps following the discussions held.
APP invited any comments or questions from the floor.
EV is concerned about giving score 0 to pesticides/biocides according to the proposed deselecting criteria discussed previously. JRR explained that we need a procedure to prioritise
the substances. The proposal is to apply a 0 ranking unless evidence or data is provided that
shows that certain pesticides should be kept. Information on peak exposure will be
provided on time to be used for this purpose as appropriate.
EG-R asked for more clarifications as:
- PEC/PNEC ratio will be used to rank further the substances? (AL)
- Uncertainties will be made available for both methodologies applied? (DH)
- "Other sources" than those mentioned in the 2nd slide are already included in Annex I, so
these are all sources that are going to be used? (IJ)
JRR replied affirmatively. KG added that these sources are chosen for legal purposes and
thus we should at least keep them in mind.
NH asked how the steps would be consulted? JRR answered that part of the work will be
done in parallel, but it is likely that well before the next meeting of the EG the Commission
will be able to send some papers for written consultation with the EG.
APP concluded that the EG-R agreed with the next steps to be followed.
The agreed steps are included in the following slides.
13
8. State of play of the Guidance on EQS derivation
APP informed the members of the group that the Rapporteurs meeting on EQS-TGD was
held in January this year. The main purpose of the meeting was to discuss and to establish a
common understanding on how to deal with different comments. In March, Paul
Whitehouse reported at the WG E meeting on the state of play of the guidance. In July, the
draft TGD-EQS (available on CIRCA) was sent to the UK Environment Agency and to
INERIS to be tested. As a follow up, INERIS submitted their comments based on the tests
made as well as draft data sheets for 14 substances used for this purpose (zip file available
on CIRCA). In conclusion, there are not big disagreements and most of comments are
14
editorials. The UK amended the TGD-EQS according to comments received, but there are
still some open issues left (for e.g. INERIS comments have to be discussed by the group).
APP invited any comments or questions from the floor. There were none.
9. Testing of the Guidance on EQS derivation
AJ presented to the group the outcomes of derivation of EQSs for certain substances (see
presentation and zip file with fact sheets available on CIRCA).
Terminology/glossary issues
APP informed the group that in principle the Rapporteurs agreed with the comments on
harmonisation needs and changes proposed by INERIS and therefore the text should be
improved.
The Rapporters (DH and EV) asked for more clarifications and finally agreed with INERIS
proposal.
MC commented that apart from what was already underlined by AJ, there are some other
issues, for instance no reference is made to the QA/QC Directive. On the other hand, is not
clear in the current version of the document to what overall QS is referring (in Lepper's
guidance QS was used for water).
Derivation of QSbiota sec pois
APP mentioned that Josema will take into account these comments, but the Rapporteurs
from the other sub-groups are invited to comment.
EV agreed with INERIS comments on trigger values.
HC suggested that the degree of toxicity could be a trigger value (NOEL values could be
used).
EV said that for example human fish consumption is triggered by hazardous classification
of CMRs. HC agreed with EV adding that CMR classification could be used excluding C
which might be not relevant for environmental.
On data assessment of toxicological data on vertebrates, Sandrine Andres (AS) said that
that this is only mentioned in the guidance, but the relevant information misses. EV said
that according to expertise of Dutch human toxicologists, there is not difference between
"generations". Anyway this could be made clearer, so information on effects should be
included in the guidance.
AS said that is likely to add in the table some information on reproduction studies. MH
replied that is not possible to give so specific guidance and thus expert judgment should be
used.
On efficiency absorption, MH recognised that two approaches were used (EFSA and
REACH), but this was mixed up in the last version of the TGD-EQS.
On endocrine disruptors, AL asked why an additional factor step is needed? EV replied that
the lowest end point is fish and this is due to the endocrine disruptors, so another AF might
be not needed. HC commented that an extra factor would be used when you have for
instance evidences of endocrine disruption properties for mammalian, also when there are
not any other data available and if this is not already covered by EC10 or NOEC.
EV decided that the references need a closer look.
Derivation of QSsed
AJ said that these comments are related to the last point discussed.
Marc Babut (MB) agreed with EV view in relation to section 2.6.1.1. In addition to that,
bilateral discussions between sediments sub-group and INERIS are foreseen.
15
MB continued that second comments on partition coefficients is more related to the general
issue and thus not specific for sediments; could be applied for overall QS. EV agreed that
this is applicable in case of very hydrophobic substances.
As regards the default parameters, MB said that this was already previously discussed.
On equilibrium partitioning methodology – section 5, MB commented that this depends on
what part is analysed: could be total sediment or suspended matter. For the moment this is
still disputed within the sub-group on sediment. EV answered that suspended matter is
representative for the upper layer. It is still not decided in which situation organic carbon
should to be analysed. AS emphasized that this is needed as long as the outcomes of
calculations vary quite a lot. EV supported AS idea; it is about a factor of two.
MC recalled to the EG that CMA is working on the establishment of guideline on sediment
monitoring. MC is required to delete the sentence referring to “the implementation of
sediment standards as statutory instruments”. MB replied that sediments sub-group
opposed to consider QS for sediment at the same level as those for water and biota. DH
clarified that this has to be seen in the light of the next steps that need to be applied. JRR
intervened saying that this statement goes beyond the technical discussions and the
mandate of the group. There are 2 possibilities: delete the paragraph or transform it into
simple observations.
AL commented that there are lot uncertainties for determination of hydrophobic substances
in sediment compartment. JRR underlined that this will not prevent to regulate this type of
substances.
10. Identification and discussion on key open issues on the Guidance on EQS
derivation
EV introduced the open points to the EG-R.
Metals: The Netherlands is complaining that trigger values are more ambitious than those
applied under Drinking Water Directive. KaD replied that this part could be reformulated.
Sediments: As general remark, it is considered that are still many open issues that need
more work. HC said that references are not yet covered, but will be dealt with. KaD added
that also the boundaries have to be refined.
Non-testing approaches: there are no comments.
HC added that there is also the issue on smelling and tasting according to requirements for
fish and shellfish; this is not yet covered by the TGD (e.g. MTBE). JRR agreed with the
comment on drinking water issue, because this is covered in WFD Article 16, but not for
the smell and tasting of shellfish. If there is a need to set QS to protect some areas where
shellfish exist, this has to done at the national level and should be dealt according to
protected areas requirements.
APP requested to send the relevant comment in writing in October, 5th before WG-E
meeting (8-9 October 2009)
JRR asked whether all the open issues were clarified or is still something left to be
addressed with WGE? AL replied that he would provide additional comments on drinking
water.
DH proposed to extend the deadline for the completion of the guidelines till the end of the
year. JRR responded that this have to be finalised having in view that the procedure of
approval is long. However, if there are still technical adjustments that cannot be contested
by the policy side is not problematic. WD meeting is scheduled at the end of November.
The guidance should be concluded by then. If there is a need for editing or completing
some technical issues it might be done afterwards as long as there is no doubt that those
can be contested. DH underlined that in addition to the open issues, the outcomes of testing
16
need to be considered. JRR pointed out that now we have to reach an agreement on what to
be included and then only the implementation part remains.
HC recalled that a guideline is quite an important issue and thus have to be mature enough
to be issued. JB stressed that WG E may provide other comments and therefore the TGDEQS will need definitely another review. JRR responded that this is not the normal
procedure of approval; if something is not agreed by WG this is sent further to SCG and if
not to the WD (this is the hierarchical way foreseen).
APP concluded that the open issues would be sent to the WG E. JRR added that SCG
meeting is scheduled on 4-5 November. The documents to be endorsed need to be sent to
the SCG at least 2 weeks in advance to the meeting. APP concluded that the rapporteurs
will plan the next steps considering the calendar for endorsement outlined above.
11. Proposal for a template for substance data sheets (as regards its usefulness for
EQS derivation)
This agenda item was discussed in the previous day together with Agenda point 4.4.
12. Finalisation of the Guidance on EQS derivation
This point was also addressed before.
AOB
JB reminded the EG-R that Denmark proposed yesterday to add on the Agenda a point
discussion on possibility to share the available EQSs data sheets established at national
level by the Member States.
JB invited EG-R members to comment on this issue. EV said that an informal group has
already been established some time ago between several Member States that share
information on EQSs. JRR added that the Commission is working on the preparation of the
Draft Mandate for the new group on Chemical Status which is a joint group of WG E and
CMA. This new mandate foresees already exchange of information between Member
States, but how this will be made operational is another discussion. EV said that the
Netherlands has already experience on this issue, so we can share how this in working in
practical terms. JB pointed out that while this is time consuming, it also has merits/real
benefits.
JRR informed the EG that JRC-IES will organise a workshop on specific pollutants and
this will be a good opportunity to exchange such type of information. In any case it seems
effective to use the existing informal group as a starting point for sharing information.
JB recalled that next meeting is foreseen at the end of January and till then the EG will
communicate via e-mail/phone. JB thanked participants for active contribution during the
meeting.
APP pointed out that all the presentations and meeting documents could be downloaded
from WFD CIRCA using the following direct link:
http://circa.europa.eu/Members/irc/env/wfd/library?l=/working_groups/priority_substances
/priority_substances_1/21-22_september&vm=detailed&sb=Title as well as from the
following Ex-ECB web page: http://ecb.jrc.ec.europa.eu/eg-eqs/.
17
Annex 1
EUROPEAN COMMISSION
JOINT RESEARCH CENTRE
Institute for Health and Consumer Protection
Consumer Products Safety & Quality Unit
15 September 2009
EXPERT GROUP ON REVIEW OF WFD PRIORITY SUBSTANCES LIST
DG ENVIRONMENT, AVENUE DE BEAULIEU 5, BRUSSELS
21-22 SEPTEMBER 2009
DRAFT REVISED AGENDA
Monday, 21 September 2009: ROOM 4/53
Start: 10:00 h – End: 18:00 h
Chairs: Ana PAYA-PEREZ (JRC-IHCP) and John BATTY (DEFRA, UK)
Item
1. Welcome and adoption of the Agenda
2. Presentation of the document WGE(6)-09/03 on overall
prioritisation process
Documents:
– Updated version of the document WGE(6)-09/03 Review of the
WFD Priority Substances List (Annex 1 provided separately to be
presented under agenda point 5)
Key issues:
– The document was presented at the WG E6 in July 2009.
Expected outcome:
– The presentation of the document at the beginning of the meeting
intends to set the scene, but the discussion should take place under
the following agenda points.
3. Mandate of the Expert Group on Review
Discussion
Presentation
Chair
DG ENV
DG ENV
Documents:
– Proposal for working methods for the Expert Group (presentation)
Key issues:
– The main lines of the mandate of the Expert Group have been
supported by the WGE at the meeting in July and are included in the
document WGE(6)-09/3 (see section 7)
Expected outcome:
– The Expert Group should discuss and clarify the mandate given and
the working methods proposed.
18
4. Review of the results of monitoring-based prioritisation:
– proposals for testing of quality and representativeness of
monitoring data and for presentation of results
– proposal for a template for substance data sheets (as regards
its usefulness for the review process)
Discussion
Commission
consultant
Documents:
– Updated version of the report WGE(6)-09/04 Prioritisation process.
Monitoring based ranking.
– Overview of comments received on the report WGE(6)-09/04
Prioritisation process. Monitoring based ranking
– Proposal for testing of quality and representativeness of monitoring
data and for presentation of results
– Draft Template for a substance data sheet
Key issues:
– One of the main elements in the mandate of the Expert Group is to
review the results of the monitoring based prioritisation as presented
in document WGE(6)-09/04.
– The document “Proposal for testing...” includes the tests included
already in the Annex to the report on Monitoring based ranking and
some additional information on the monitoring database, including
the information already available on the website.
– A template is also proposed for the substance data sheets
Expected outcome:
– The Expert Group is invited to discuss and agree the structure and
information provided on the monitoring database and in the data
sheets, as presented in the documents. Once agreed, these will be the
basis of the discussions at the Expert Group.
19
5. Comments received on document WGE(6)-09/03
– Annex 1
– Screening criteria
Discussion
DG ENV
Documents:
– Updated Annex 1 to document WGE(6)-09/03 Review of the WFD
Priority Substances List
– Overview of comments received on document WGE(6)-09/03
Review of the WFD Priority Substances List
– Proposals for screening of the Annex 1 list of candidate substances
(presentation)
Key issues:
– The main comments received and the changes made to Annex 1 will
be presented.
– It is the intention of this meeting to discuss mainly the screening
criteria to reduce the list of Annex 1 to a number of substances that is
manageable for further in depth analysis.
– The intention is not to agree Annex 1, which will not be finalised
until the modelling based prioritisation is concluded.
Expected outcome:
– The Expert Group is invited to discuss and develop the screening
criteria.
6. State of play and outlook of modelling-based prioritisation
Documents:
– Final list of universe of chemicals for the modelling based
prioritisation
Key issues:
– The state of play of the modelling based prioritisation will be
presented.
Expected outcome:
– The Expert Group is invited to take note and discuss the progress of
the work.
7. Next steps on the review
JRC-IHCP
DG ENV
Key issues:
– Proposals for next steps will be presented according to the results of
the discussions held.
Expected outcome:
– The Expert Group is invited to discuss and agree the proposed
calendar and next steps.
20
Tuesday, 22 September 2009: ROOM 3/30
Start: 9:00 h – End: 18:00 h
Chairs: Ana PAYA-PEREZ (JRC-IHCP) and John BATTY (DEFRA, UK)
Item
8. State of play of the Guidance on EQS derivation
Documents:
– Final draft of the TGD-EQS
Key issues:
– The final draft of the guidance will be presented
Expected outcome:
– The Expert Group is invited to take note of the state of play.
9. Testing of the Guidance on EQS derivation.
Documents:
– Draft data sheets presenting the results of the application of the
guidance for a number of substances.
Key issues:
– INERIS tested the draft guidance on a number of substances. The
experience of the testing will be presented.
– The draft data sheets are presented for information only and will not
be the subject of the discussion. The selection of substances for the
testing does not intend to pre-judge any conclusion of the Expert
Group as regards the results of the review.
Expected outcome:
– The Expert Group is invited to take note of the experience by INERIS
on the testing exercise and consider this in the finalisation of the
guidance.
10. Identification and discussion on key open issues on the Guidance
on EQS derivation
Presentation
Chair
Rapporteurs
Commission
consultant
Chair
Rapporteurs
Documents:
– Presentation on key open issues on the TGD-EQS as highlighted on
the final draft
Key issues:
– Open issues identified by rapporteurs will be discussed.
Expected outcome:
– The Expert Group is invited to discuss and agree a way forward on
the open issues.
21
11. Proposal for a template for substance data sheets (as regards its
usefulness for EQS derivation)
Commission
consultant
Documents:
– Draft data sheets presenting the results of the application of the
guidance for a number of substances.
– Draft Template for a substance data sheet
Key issues:
– The draft template for substance data sheets will be discuss as regards
its usefulness for the discussions about the derivation of EQS.
Expected outcome:
– The Expert Group is invited to discuss and agree the structure of the
substance data sheet.
12. Finalisation of the Guidance on EQS derivation
Chair
Expected outcome:
– The Expert Group is invited to discuss and agree the way forward for
the finalisation of the guidance.
AOB
Chair
- Next meeting
22
Annex 2
List of participants
Expert Group on Review of WFD Priority Substances List
21 - 22 September 2009
Venue:
DG ECFIN, BU 24, Room 1/58 (21 September 2009)
DG ENVIRONMENT, BU 5, Room A (22 September 2009)
Member States
Name
County
Institution/e-mail address
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
Raphaël
France
Ministère de l'Energie, de l'Ecologie, du
DEMOULIERE
Développement Durable et de l'Aménagement du
Territoire
e-mail address:
Raphael.Demouliere@developpementdurable.gouv.fr
Marc BABUT
France
Agriculture and Environmental Engineering
Research (Cemagref)
e-mail address: marc.babut@cemagref.fr
Mélissa DALLET
France
Institute
Français
de
Recherche
pour
L'Exploitation de la Mer (IFREMER)
e-mail address: melissa.dallet@ifremer.fr
Petra RINGELTAUBE Germany
Federal Environment Agency
e-mail address: petra.ringeltaube@uba.de
Mario CARERE
Italy
Ministry of the Environment and Land Protection
e-mail address: m.carere@iss.it
Theodora TEN
HULSCHER
Netherlands
Water Management Partnership (RWS)
e-mail address: dorien.ten.hulscher@rws.nl
Eric VERBRUGGEN
Netherlands
National Institute for Public Health
Environment (RIVM)
e-mail address: eric.verbruggen@rivm.nl
and
23
Helene LAGER
Henning CLAUSEN
Sweden
Denmark
Environment Protection Agency
e-mail
niklas.johansson@naturvardsverket.se
Environment Protection Agency
e-mail address: hcl@mst.dk
address:
Stakeholders
Name
Organisation/e-mail address
Ismene JAEGER
European Environmental Bureau (EEB)
e-mail address: info@oekologischenetze.de
Nadia HAIAMA
Greenpeace
e-mail address: Nadia.Haiama@greenpeace.org
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
Katrien DELBEKE
European Cooper Institute (ECI)
e-mail address: kmd@eurocopper.org
Frank VAN ASSCHE
International Zinc Association (IZA)
e-mail address: fvanassche@izaeurope.com
Klaas DEN HAAN
Oil Association (CONCAWE)
e-mail address: klaas.denhaan@concawe.org
Mick HAMMER
Syngenta Crop Protection
e-mail address: mick.hamer@syngenta.com
Dolf VAN WIJK
European Chlor-Alkali industry (Euro Chlor)
e-mail address: dvw@cefic.be
24
European Commission
Name
Jorge RODRIGUEZ
ROMERO
Madalina DAVID
Institution/e-mail address
DG ENV, D2
e-mail
address:
Jorge.RODRIGUEZROMERO@ec.europa.eu
DG ENV, D2
e-mail address: Madalina.DAVID@ec.europa.eu
Karola GRODZKI
DG ENTR, G2
e-mail address: Karola.GRODZKI@ec.europa.eu
Steven EISENREICH
JRC – Brussels
e-mail address: Steven.EISENREICH@ec.europa.eu
Ana PAYA PEREZ
JRC-IHCP, I2
e-mail address: Ana.PAYA-PEREZ@ec.europa.eu
Klaus DAGINNUS
JRC-IHCP, I6
e-mail address: Klaus.DAGINNUS@ec.europa.eu
Sandrine ANDRES
Consultant – INERIS
e-mail address: Sandrine.ANDRES@ineris.fr
Alice JAMES
Consultant – INERIS
e-mail address: Alice.JAMES@ineris.fr
Benoît FRIBOURG-BLANC
Consultant – IOW
e-mail address: b.fribourg-blanc@oieau.fr
25