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Document 52011SC1544
COMMISSION STAFF WORKING PAPER TECHNICAL BACKGROUND
COMMISSION STAFF WORKING PAPER TECHNICAL BACKGROUND
COMMISSION STAFF WORKING PAPER TECHNICAL BACKGROUND
/* SEC/2011/1544 final */
COMMISSION STAFF WORKING PAPER TECHNICAL BACKGROUND /* SEC/2011/1544 final */
Disclaimer: This document is a European
Commission staff working document and is for information only. It is not a
statement of the Commission's current or future official position on the
subject it addresses. TABLE OF CONTENTS 1........... Review process.............................................................................................................. 5 1.1........ Tasks............................................................................................................................. 5 1.2........ Participants in the review................................................................................................. 5 1.3........ Summary of approach and outcomes............................................................................... 6 1.3.1..... Proposed Priority Substances......................................................................................... 6 1.3.2..... Existing PS..................................................................................................................... 6 2........... Process for prioritisation of
new Priority Substances........................................................ 6 2.1........ Background.................................................................................................................... 6 2.2........ Overall approach to
prioritisation.................................................................................... 8 2.3........ Risk assessment carried out under
the chemicals, plant protection products and biocides legislation 9 2.3.1..... Existing Substances Regulation
(EEC) No.793/93........................................................... 9 2.3.2..... Plant Protection Products
legislation Directive 91/414/EEC (Regulation (EC) No 1107/2009) 10 2.3.3..... Biocides legislation Directive
98/8/EC........................................................................... 11 2.4........ Targeted risk assessments
focusing on aquatic ecotoxicity and on human toxicity via the aquatic
environment 11 2.5........ Simplified risk-based assessment
procedure based on scientific principles...................... 11 2.5.1..... Monitoring-based prioritisation...................................................................................... 12 2.5.1.1.. Creation of the database............................................................................................... 12 2.5.1.2.. Selection of substances for ranking................................................................................ 14 2.5.1.3.. Criteria for ranking: consideration
of exposure and effects data...................................... 15 2.5.1.4.. Prioritisation algorithm................................................................................................... 16 2.5.1.5.. Additional checks......................................................................................................... 16 2.5.1.6.. List of substances prioritised
through monitoring............................................................ 17 2.5.2..... Modelling-based prioritisation....................................................................................... 19 2.5.2.1.. Starting list: Universe of
chemicals................................................................................. 19 2.5.2.2.. Data collection: Exposure and
hazard assessment.......................................................... 20 2.5.2.3.. Risk ranking................................................................................................................. 20 2.5.2.4.. List of substances prioritised
through modelling.............................................................. 21 2.6........ Priority hazardous substances
criteria............................................................................ 22 2.6.1..... REACH Substances of Very High
Concern (SVHC)..................................................... 22 2.6.2..... Persistent Organic Pollutants
(POPs) under the Stockholm Convention.......................... 22 2.6.3..... Substances identified as
Persistent, Bio-accumulative and Toxic (PBTs) under Regulation (EEC) No.793/93 22 2.7........ Other sources for identification
of candidates for prioritisation........................................ 22 2.8........ Approach to shortlisting................................................................................................ 23 2.8.1..... Short-listing from the first
candidate list.......................................................................... 23 2.8.2..... Preparation of substance dossiers
and further short-listing.............................................. 24 2.9........ Annex III of EQSD substances..................................................................................... 28 2.10...... Approach to substances that might
pose a specific risk to drinking-water supplies.......... 30 3........... Environmental Quality Standards
(EQS) derivation and revision..................................... 31 3.1........ Technical Guidance on
Environmental Quality Standards derivation (TGD EQS)............ 31 3.2........ Derivation of EQS for Proposed
Priority Substances..................................................... 32 3.3........ Revision of EQS for Existing
Priority Substances........................................................... 33 4........... Priority Hazardous Substances
(PHS) status.................................................................. 35 4.1........ Definition and criteria.................................................................................................... 35 4.2........ Review......................................................................................................................... 36 4.2.1..... Changes to existing Priority
Substances......................................................................... 36 4.2.2..... Proposed new Priority Hazardous
Substances............................................................... 43 5........... Technical background documents.................................................................................. 44
1.
Review process
1.1.
Tasks
In summary, the main tasks of the technical
review of the Priority Substances list under the Water Framework Directive (WFD[1]) were to
prioritise possible new Priority Substances (PS), considering among others the
substances in Annex III to the EQS Directive (EQSD[2]),
to set appropriate EQS, and to review whether changes should be made to the EQS
or status (as PS or Priority Hazardous Substances (PHS)) of existing PS. The
outputs of the technical process were therefore a list of possible new
substances, EQS for them and for some existing substances, and PHS
classifications. In addition, and in the context of the subsequent impact
assessment, the need for additional control measures for existing and new
priority substances was investigated.
1.2.
Participants in the review
The technical process of the review was
developed by the WFD Common Implementation Strategy (CIS)[3], [4]
Working Group E (Chemical Aspects, formerly called Priority Substances),
operational since 2007 when it superseded the Expert Advisory Forum established
in 2001. WG E contributed in various ways to the review of the EQS Directive,
supporting the collection of data (including monitoring and hazard data and
information on control measures), the prioritisation exercise, the update of
the Technical Guidance Document on EQS (TGD-EQS) and the derivation of EQS. Two
expert groups were set-up as sub-groups of WG E: the Expert-Group on the
Technical Guidance Document EQS (EG-EQS), and the Sub-Group on Review of
Priority Substances (SG-R). The membership of WG E and the two expert groups
consists of Commission DGs, Member States and stakeholder organisations
including a range of industry bodies and NGOs. A list of Members is available
on the Register of Commission Expert Groups[5]. The SG-R was mandated to support the
prioritisation, to propose the candidate substances to be included in the PS
list, and to propose EQS for them in water, sediment and/or biota as
appropriate. It also provided advice on the revision of water EQS and the development
of sediment and biota EQS for existing PS. It was assisted in its work by
Commission consultants INERIS and the International Office for Water. The
outputs of SG-R's technical work were regularly presented and discussed in WG E
meetings during the review process. In support of the EQS-setting and revision
processes, it was necessary to update the guidance document on EQS derivation.
This was done by the EG-EQS in parallel with the prioritisation work. The EQS
derivation and revision were then carried out according to the updated
guidance. The guidance and the draft EQS were submitted to the Scientific
Committee on Health and Environmental Risks (SCHER) for its opinion. Further
details are provided in later sections.
1.3.
Summary of approach and outcomes
1.3.1.
Proposed Priority Substances
The prioritisation process took account of
several information sources and arrived at a short-list of 19 substances, for
which EQS were derived, though not all the substances appear in the proposal
for the reasons explained in section 2.8.2. During the review, particular consideration
was given to the substances in Annex III to the EQSD. Section 2.9 explains how these substances ranked in relation
to others shortlisted during the prioritisation process, and what led to their
inclusion in or exclusion from the options and the final proposal. Consideration was also given to substances
that might pose a particular risk to drinking water supplies. Data were
requested from WG E on concentrations of such substances in water bodies used
for the abstraction of drinking water, and in drinking water itself. For none
of the substances were the data conclusive. For this reason, no substances were
identified that would require the setting of a standard specific to water
bodies used for the abstraction of drinking water. Section 2.10 provides more
details. For all the proposed priority substances,
consideration was given to their hazardousness (in particular as judged under
other legislation) and the exposure of the aquatic environment (and humans via
the aquatic environment) to them in order to determine whether they should be
classified as PHS. Six were identified as PHS. The considerations for each
substance are summarised in section 4.2.2.
1.3.2.
Existing PS
A review of new risk assessments of the
existing PS led to the conclusion that the EQS for seven substances should be
revised and/or established for biota instead of water. Details are provided in
section 3.3. New information that might affect the
status of existing PS was also reviewed, and this led to the proposal that two
existing substances be reclassified as PHS, as outlined in section 4.2.1.
2.
Process for prioritisation of new Priority Substances
2.1.
Background
According to WFD Article 16(1), the
Commission should identify priority substances (PS) among those presenting a
significant risk to or via the aquatic environment, including such risks to
waters used for the abstraction of drinking water. Article 16(2) establishes
that the identification of PS should be based on 1.
Risk assessment carried out under the chemicals,
pesticides (plant protection products) and biocides legislation (Regulation
(EEC) No.793/93, Directive 91/414/EEC (now Regulation (EC) No 1107/2009) and
Directive 98/8/EC respectively) 2.
Targeted risk assessments focusing on aquatic
ecotoxicity and on human toxicity via the aquatic environment 3.
Simplified risk-based assessment procedure based
on scientific principles taking particular account of · Evidence regarding the intrinsic hazard of the substances, · Evidence from monitoring of widespread contamination · Other elements that may indicate widespread contamination such as
production volumes and use patterns At the time the first identification of PS
was carried out (list of 33 PS established in 2001 by Decision 2455/2001/EC),
very few risk assessment were available under the chemicals, pesticides and
biocides legislation. The COMMPS (combined monitoring-based and
modelling-based priority setting) procedure[6] was developed
as a simplified risk-based assessment that combined the available information
on the intrinsic hazard of substances (first bullet under point 3 above) with
estimates of exposure based on monitoring information (second bullet under point
3 above) and modelling information derived from production volumes and use
patterns (third bullet under point 3 above). The current situation is very different
from ten years ago in that the implementation of the legislations on chemicals,
pesticides and biocides has progressed substantially. Risk assessments have
been concluded for many substances and need to be taken into account when
identifying priority substances under the WFD. In addition, risk assessments
are available in draft stage for a number of substances and other substances
have undergone voluntary risk assessments. At the time of development COMMPS was
welcomed as a pragmatic approach towards prioritisation. The Scientific
Committee on Toxicity, Ecotoxicity and the Environment published an opinion on
COMMPS[7] that identified a number
of elements for improvement in the future. This opinion and the discussions
among Commission services, Member States and stakeholder experts were
considered in the development of an improved methodology for prioritisation.
This was developed (starting in 2007) by the Working Group E on Chemical
Aspects under the WFD Common Implementation Strategy (CIS). The following sections explain how the
three bases for PS identification presented in WFD Article 16(2) have
determined the methodology used in the current review.
2.2.
Overall approach to prioritisation
The overall
approach was based on the criteria set out in the WFD Article 16(2) and built
on the experience gained with the COMMPS procedure (see below). It is
recognised that there is no single approach that is best for prioritisation,
all have their advantages and disadvantages. A combination of different
approaches was considered the best to identify candidates for the priority
list. The approaches were based on the following,
which were developed as parallel prioritisation processes and subjected to
expert review: ·
Risk assessment carried out under the chemicals,
pesticides and biocides legislation ·
Targeted risk assessments focusing on aquatic
ecotoxicity and on human toxicity via the aquatic environment ·
Simplified risk-based assessment procedure based
on scientific principles taking particular account of –
Evidence regarding the intrinsic hazard of the
substances, and –
Evidence from monitoring of widespread
environmental contamination and –
Other elements that may indicate widespread
contamination such as production volumes and use patterns ·
Priority Hazardous Substances criteria (PBT or
equivalent level of concern), including Substances of Very High Concern under
REACH and POP criteria ·
Other sources of information –
Substances of concern at Member State level –
Annex III of EQSD Directive 2008/105/EC The processes led to separate but
complementary lists of substances. The lists or at least the highest-priority
substances on each list were amalgamated and subjected to a short-listing
procedure involving further expert review. The range of processes took
advantage of the most relevant available information. Inevitably there was some
overlap between the lists, despite the independence of the processes, and this
made the case for prioritising some substances particularly strong. The
individual processes and the short-listing procedure are illustrated in Figure
1 and described in the following sections. The short-listed substances were
subject to a detailed expert review on the basis of dossiers prepared by the
Commission and Member States experts in the Sub-Group on Review. The following sections describe more in
detail the different sources of prioritisation and how the short-listing was
carried out. Figure 1: Overall approach to
prioritisation
2.3.
Risk assessment carried out under the chemicals,
plant protection products and biocides legislation[8]
2.3.1.
Existing Substances Regulation (EEC) No.793/93
From 1994 to 2009, a total of 4 priority
lists comprising 141 substances were drawn up by the Commission in consultation
with Member States to carry out risk assessments under Regulation (EEC)
No.793/93 (see http://esis.jrc.ec.europa.eu/). Risk assessment reports were concluded for 102 substances. Among
those, and without counting existing PS, 49 pose identified risks to or via the
aquatic environment and for 35 a Commission Recommendation to reduce risk has
been published in the Official Journal. The risk assessment reports (RAR) for
existing chemicals that included a conclusion iii[9] for the aquatic environment were screened to extract the Predicted
Environmental Concentrations (PECs), Predicted No Effect Concentrations (PNECs)
and risk ratios. The following criteria were applied when
considering whether to further consider the substance: ·
The default option was to select the substance
for further review in view of the conclusion iii on risks to or via the aquatic
environment. ·
Only final RARs were considered. Draft RAR were
not deemed sufficient to consider the substance further. ·
If the risk assessment clearly indicated that
the conclusion iii was reached for a local scenario or for only a few sites,
and the scenario was not likely to be present in a significant number of river
basins in the EU, the substance was not considered further. If the risk was
labelled "local" but related to widespread uses then it was deemed
appropriate to identify the substance for further review. In case of doubt
about whether the use was widespread or not the substance was kept for further
review. The assessment concluded with 12 substances
selected for preparation of detailed dossiers out of the 49 substances with
conclusion iii for the aquatic environment.
2.3.2.
Plant Protection Products legislation Directive
91/414/EEC (Regulation (EC) No 1107/2009)
As at 23 June 2009, 334 active substances
were included in Annex I of Directive 91/414/EEC, i.e. authorised for use in
plant protection products, and 766 active substances had been subject to a
non-inclusion decision. Annex I of Directive 91/414/EEC identifies 151 of the
334 active substances authorised as needing risk reduction measures due to the
risk to surface waters. The Sub-Group on Review decided not to
investigate further those plant protection products (PPPs) that have been
authorised, and are therefore included in Annex I to Directive 91/414/EEC, but
for which there is no other source of information for prioritisation, i.e. they
are not ranked high in either the monitoring-based or the modelling-based
approach, nor identified as a PBT, POP, SVHC or Annex III substance. PPPs
subject to a non-inclusion decision under Directive 91/414/EEC and not ranking
high in any of the ranking exercises were also not investigated further. The Sub-Group considered information on the
peak concentrations of the PPPs in the monitoring database in order to ensure
that the averaging involved in the PEC calculation in the monitoring-based
prioritisation did not overlook important information on short-lived high
concentrations. The risk assessments for the remaining 11 PPPs
were screened to extract the relevant information. The Toxicity Exposure Ratios
(TERs) were used to rank the PPPs as far as the available information allowed.
Eight out of the 11 PPPs ranked high in the modelling-based prioritisation and
4 out of 11 ranked high or very high in the monitoring-based prioritisation.
Methiocarb (aka mercaptodimethur) and Deltamethrin ranked very high in the
monitoring-based prioritisation but were proposed for de-selection because the
available monitoring information was not sufficiently representative of an EU
risk and had not been identified by any other prioritisation process.
2.3.3.
Biocides legislation Directive 98/8/EC
At the time of short-listing there were 29
active substances in Annex I of Directive 98/8/EC, i.e. authorised for use. Of
those, the annex identifies risks to the aquatic environment in 13 cases.
Around 300 active substances were under review at that moment. The same criteria were applied to biocides
as to PPPs, i.e. no further investigation was proposed if the substance was not
ranked high in any of the ranking exercises and they were not identified as a
PBT, POP, SVHC or Annex III substance. Only one substance remained after applying
these criteria: Tolylfluanid, which is also authorised as a PPP. Its risk assessment
under the biocides legislation was examined and the substance was further
investigated.
2.4.
Targeted risk assessments focusing on aquatic
ecotoxicity and on human toxicity via the aquatic environment
On the basis that voluntary risk
assessments had been concluded by industry on Copper and by the UK on PFOS, in
both cases showing conclusion iii for the aquatic environment for some
scenarios and uses, these substances were further reviewed.
2.5.
Simplified risk-based assessment procedure based
on scientific principles
A simplified assessment procedure was
developed for the current prioritisation by the Sub-Group on Review, largely
building on the experience of COMMPS and the opinion on this methodology
received from the Scientific Committee on Toxicity, Ecotoxicity and the
Environment[10] (SCTEE, now Scientific Committee on Health and Environmental Risks
– SCHER). The Sub-Group decided to run the following
2 methodologies in parallel: –
A monitoring-based methodology elaborated
by DG Environment’s consultant INERIS-IOW, and –
A modelling-based methodology developed
by the Sub-Group based mainly on an UK methodology modified and implemented by
the JRC The methodologies complement each other, as
the SCTEE recognised in its opinion[11]. Both incorporate information on the intrinsic hazard of
substances, i.e. first bullet under point 3 in section 2.1 above. The
monitoring-based methodology builds on the second bullet under point 3 in
section 2.1 above and the modelling-based methodology on the third bullet under
point 3.
2.5.1.
Monitoring-based prioritisation
As recognised by
the SCTEE, the monitoring-based approach is an excellent basis for
prioritisation as it provides direct evidence of the presence of substances in
the environment. A preliminary monitoring-based
prioritisation was conducted in 2008 leading to the compilation of a database
and a first-stage ranking report. Following extensive discussions, gaps and
improvements were identified and a second data collection and an improved
prioritisation methodology were implemented. A monitoring-based list of
substances was then proposed. The steps involved were: data gathering,
selection of relevant substances to rank, definition and application of the
criteria for ranking, development and application of the algorithm for ranking,
additional checks, and identification of the final monitoring-based list of
substances. These are described in detail below.
2.5.1.1.
Creation of the database
The monitoring-based ranking used raw
monitoring data collected in EU Member States (all except Malta) and other
European countries (Norway and Switzerland). Minimum information criteria for
use of the data in the prioritisation were defined. With each analysis, 22
mandatory pieces of information were required, and a large set of additional
information if available. The Sub-Group developed a template for the data
collection which was implemented in a data-collection tool. This tool was used
by almost every country to prepare its dataset: gather individual data, check
for completeness, and export the resulting dataset for submission to the
Commission. In the received datasets, various validity checks were implemented
before the data were gathered in a central database. Figure 2: Data collection, template, tool
and database Many differences in presentation and content
were found, including the use of more than 150 different units. Some
preliminary treatment was therefore necessary, e.g. to express all results in
µg/l for water analyses and µg/kg for sediment and biota analyses. Overall, 14.6 million analyses from 19 900
stations in 28 countries and covering 1151 substances were reported.[12] All 4 WFD surface
water categories (rivers, lakes, transitional and coastal waters) were
represented, river stations being predominant as illustrated in the following
map (Figure 3). Data were provided on three fractions of
water, four fractions of sediment and eight fractions of biota, water data
being by far the most dominant.
2.5.1.2.
Selection of substances for ranking
Considering the tight schedule and the
available resources, it was not possible to use the complete dataset. In
addition, Figure 4 on the number of countries that reported data on the various
substances (independent of fraction) shows that most substances were reported
on by only a small number of countries, hence not necessarily representative of
the situation in the EU. Figure 4: Number of countries reporting
data per substance Since the WFD intends that PS be of EU-wide
concern, the ranking step was restricted to substances monitored in at least 4
countries, i.e. to 316 substances.
2.5.1.3.
Criteria for ranking: consideration of exposure
and effects data
The prioritisation took account of the
combination of: ·
exposure data (Predicted Environmental
Concentration) expressed as a single concentration, based on the available EU
monitoring data, and ·
effect data (Predicted No Effect Concentration)
selected from the literature for the sole purpose of prioritisation. The exposure data were calculated from the
monitoring data as arithmetic means at the level of each monitoring station for
each analysed fraction (whole water, dissolved metals in water, sediment below
2mm, below 63µm, below 20µm, fish and invertebrates), and then as 90th
percentiles of the means from all stations. If collected data are
representative of the EU situation, 90% of the stations would be expected to
experience average concentrations below this value, i.e. below the PEC. In
terms of risk assessment, this implies that if the PEC is below the PNEC, 90%
of the station locations are, on average, expected to present safe
concentrations. In practice, difficulties arise because of measurements that
are below the analytical determination limit. Two PEC calculations were
consequently calculated, one using only quantified values (PEC1), the other
using all available data (PEC2). In the latter data below the determination
limit was replaced by half its value as recommended by the QA/QC Directive
(2009/90/EC)[13]. Two PEC/PNEC risk ratios could then be
derived for each fraction (where data were available). In some cases the results
may have reflected insufficient analytical performance rather than real risk.
It was therefore necessary to assess the relevance of the ratios. This was done
first by discarding cases where the risk based on PEC2 was >1 whilst that
based on PEC1 was <1, second by checking that PEC1 > PEC2, and third by
considering for ranking in the monitoring-based prioritisation only the
substances where the number of quantified analyses is more than 2% of the total
number of analyses. The effect data considered were ecotoxicity
data for the different fractions covered by the monitoring data. They were
obtained during an extensive literature review in the spring of 2009. For
water, direct ecotoxicity was considered and a PNEC calculated using the
original Technical Guidance Document on Risk Assessment. For sediment, PNEC
values were calculated by applying the Equilibrium Partitioning method using
PNECwater and Koc as input parameters. For biota, risk of
secondary poisoning for predators and risk to human health via consumption of
contaminated aquatic biota were assessed and the PNEC based on the higher risk. Drinking water standards were compared with
the PECs to provide an indication of the removal efficiency that might be
required to produce drinking water. For metals, PNECs in water and biota were
proposed, based on substance factsheets or on the relevant RARs.
2.5.1.4.
Prioritisation algorithm
For each fraction, five risk-ratio
categories were defined: Very High, High, Medium, not Applicable and Low[14]. The overall
priority is defined by the maximum priority amongst the calculated risk ratios
for all fractions. Specific cases were made for substances
relevant to drinking water, where drinking water standards or guidelines were
considered in place of the PNEC for the ratio calculation. Specific cases were
also made for PCBs, where results for total PCBs were compared to results on
each individual PCB, and to the sum of these individuals. Specific case is also
made for dioxins/furans where the sum of all dioxin like substances is made
using the Toxic Equivalent Factor (TEF) approach.
2.5.1.5.
Additional checks
Substances in the very high and high
categories were selected for additional checks[15]. Since not all fractions needed to be classified in these
categories to make the substance rank high or very high, it was important to
check the EU representativeness of the monitoring data for the fraction(s)
leading to this ranking. Additional checks on the quality and reliability of
the monitoring data were also done to ensure that the selection had a solid
basis. As a result of these checks, some substances were identified as
candidates for de-selection. In particular, when the substance was not
monitored by at least 3 countries in the determinant fraction resulting in high
or very high risk, the substance was identified as candidate for de-listing
subject to a final consideration. Non-quantified analyses for which the limit
of determination was more than twice the PNEC were considered unreliable. The
PEC values and risk ratios were recalculated without these data and if the
substance was no longer ranked as very high or high it was identified as a
candidate for de-selection, also subject to a final consideration.
2.5.1.6.
List of substances prioritised through
monitoring
After application of the algorithm and the
additional checks, a list of 36 organic compounds and 4 metals was obtained, 19
of these identified for de-selection. Table 1: List of substances prioritised
through monitoring No. || SubstanceName || CAS || || No. || SubstanceName || CAS 1 || Heptachlor epoxide || 1024-57-3 || || 28 || Mevinphos || 7786-34-7 2 || Heptachlor || 76-44-8 || || 29 || Chloroacetic acid* || 79-11-8 3 || Permethrin* || 52645-53-1 || || 30 || Methidathion* || 950-37-8 4 || Cyanides || 57-12-5 || || 31 || Monobutyl tin compounds || 5 || Malathion* || 121-75-5 || || 32 || 2,4-Dichlorophenol* || 120-83-2 6 || Methiocarb* || 2032-65-7 || || 33 || Dioxins/Furans || 7 || Cypermethrin || 52315-07-8 || || || Dioxins/Furans/PCB dioxin-like || 8 || Deltamethrin* || 52918-63-5 || || 34 || PCBs || 9 || Parathion || 56-38-2 || || || PCBs - worst case 3 approaches || 10 || Dichlorvos || 62-73-7 || || || 2',3,4,4',5'-Pentachlorobiphenyl || 31508-00-6 11 || Dichlorodiphenyl dichloroethane - o,p' || 53-19-0 || || || 2,3,3',4,4'-Pentachlorobiphenyl || 32598-14-4 12 || Tetrabutyltin compounds* || || || || 2,2',4,4',5,5'-Hexachlorobiphenyl || 35065-27-1 13 || Triphenyltin compounds* || || || || 2,2',3,4,4',5'-Hexachlorobiphenyl || 35065-28-2 14 || Dicofol* || 115-32-2 || || || 2,2',3,4,4',5,5'-Heptachlorobiphenyl || 35065-29-3 15 || Fenitrothion* || 122-14-5 || || || 2,2',5,5'-Tetrachlorobiphenyl || 35693-99-3 16 || Diazinon* || 333-41-5 || || || 2,3,3',4,4',5-Hexachlorobiphenyl || 38380-08-4 17 || Omethoate || 1113-02-6 || || || 2,4,4'-Trichlorobiphenyl* || 7012-37-5 18 || Nitrite || 14797-65-0 || || || 2,2',4,5,5'-Pentachlorobiphenyl || 37680-73-2 19 || Phoxime || 14816-18-3 || || || 3,3',4,4'-Tetrachlorobiphenyl || 32598-13-3 20 || Chloroxuron || 1982-47-4 || || || PAHs || 21 || Azinphos-ethyl || 2642-71-9 || || 35 || Pyrene || 129-00-0 22 || Pirimiphos-methyl* || 29232-93-7 || || 36 || Benzo(a)anthracene || 56-55-3 23 || Trichlorfon* || 52-68-6 || || || Metals || 24 || 2,2',4,4'-Tetrabromodiphenyl ether* || 5436-43-1 || || 37 || Arsenic (and mineral compounds)* || 7440-38-2 25 || Fenthion || 55-38-9 || || 38 || Selenium* || 7782-49-2 26 || Chlorpyrifos-methyl || 5598-13-0 || || 39 || Uranium* || 7440-61-1 27 || Methoxychlor || 72-43-5 || || 40 || Vanadium* || 7440-62-2 * candidate for de-listing The Sub-Group on Review agreed that, due to
the limitations in the monitoring data, substances identified for de-selection
should not be subject to further scrutiny in this review if their presence in
the list of candidate substances was due only to monitoring-based
prioritisation. Dicofol and Trichlorfon ranked high also in
the modelling-based prioritisation. Dicofol is also a PBT and/or vPvB and is in
Annex III of the EQSD. Tetrabutyltin compounds were identified as PBT and/or
vPvB. Arsenic is a SVHC under REACH. 3,3',4,4'-Tetrachlorobiphenyl (PCB 77) is
a POP. Therefore these five substances were retained for further scrutiny. 2,2',4,4'-Tetrabromodiphenyl ether ranked
high in the monitoring-based prioritisation but was deleted from the list of
candidate substances because it is an existing PS (brominated diphenylether
congener BDE-47). The other substances out of the 19 that
were identified as candidates for de-selection were not considered further. The PAHs ranking high in the
monitoring-based ranking (pyrene and Benzo(a)anthracene) were also not proposed
for further consideration as PAHs are already included in the PS list. The remaining substances were then
considered alongside those in the other lists of candidate substances for
prioritisation. Twelve substances were identified for which
the ratio between the PEC and the drinking water standards was high, i.e.
substances for which high treatment removal efficiency would be necessary, and
which might therefore cause failure of the drinking water standard at the tap.
These were not immediately scrutinised further unless other sources of
prioritisation were relevant. The issue of substances that might pose a risk to
drinking water supplies is addressed in section 2.10. The detailed information collected for the
monitoring-based prioritisation, and the quantity of analyses collected allowed
a more complex approach than COMMPS, and consequently gave more representative
results. However, the methodology used to select the substances was based on
the arithmetic mean by station and did not consider seasonal emission patterns.
This was identified as a limitation of the methodology that could be addressed
in future exercises.
2.5.2.
Modelling-based prioritisation
The modelling-based
ranking involved the following steps: identification of a starting list of
substances, data collection (exposure and hazard assessment), application of
the ranking methodology, definition of a final modelling-based list of
substances. These steps, which were carried out by the Joint Research Centre
(JRC), are described below.
2.5.2.1.
Starting list: Universe of chemicals
The first step in the modelling based
approach was to define the list of substances to which to apply the ranking
methodology. Various sources where used: monitoring data from Member States
(MS), substances proposed by the European Parliament (EP) for further
investigation, stakeholders, research consortia, international organisations,
and several EU lists of substances of possible concern such as PBTs, possible
endocrine disruptors, plant protection products, etc. All these lists were
merged together to form a combined list of 2034 compounds. Metals were excluded
from this list as the majority of the tools developed for the estimation of
physical, chemical and toxicological properties have been developed to deal
with organic compounds rather than metals. Simplified
Molecular Input Line Entry Specification (SMILES) codes (descriptions of molecular
structure in short ASCII strings) were generated for 1872 substances for use in
the modelling.
2.5.2.2.
Data collection: Exposure and hazard assessment
Each substance was subjected to a hazard
assessment following the REACH Guidance on Information Requirements and
Chemical Safety Assessment. It comprised four criteria: Persistence,
Bioaccumulation, Toxicity and Endocrine Disrupting properties. When a criterion
was fulfilled, a score of 1 was given and the scores were added. If a substance
was vPvB, a score of 4 was attributed. In the absence of sufficient information
to conclude, QSAR models were used as surrogates. The assessment of persistence (P) was made
using BIOWIN (1727 substances of which 691 were P) or BIOHCWIN (142 substances
of which 41 were P) from the EPIsuite, whilst to estimate very P (vP), the OECD
Pov and LRTP screening tools were used. To assess bioaccumulation (B), measurements
of the BioConcentration Factor (BCF) in aquatic species were preferred, and B
was attributed when 2000<BCF<5000 L/kg, very B (vB) when BCF>5000
L/kg, whereas if the Log Kow <=4,5 and no specific mechanism of uptake was
identified, the substance was considered as neither B nor vB. Experimental BCF
was used but in the absence of data, other information was used in a
weight-of-evidence approach, including worst-case QSAR estimated values based
on three modelling approaches. To assess toxicity (T), REACH Annex XIII
criteria were used: either a long-term no-observed effect concentration (NOEC)
of less than 0.01mg/l, or the substance was identified as carcinogenic,
mutagenic or toxic for reproduction, or the substance had chronic toxicity
effects identified by a risk phrase under Directive 67/548/EEC. Acute studies
provided evidence of T but this needed to be complemented by chronic tests on
fish, daphnia or algae. In their absence, the screening was finalised by
applying four QSAR models generated by the ADMET modeller software to derive
acute aquatic toxicity, T being assigned if 3 of the 4 QSARs agreed on T
classification. The above scores were summed to obtain a
hazard score. The exposure was then assessed through collection of data on use
of the substances in products using the IUCLID database and SPIN. The IUCLID
database (http://iuclid.echa.europa.eu/) contains data collected through an obligation on producers and
importers of high-production-volume chemicals and low-production-volume
chemicals. The SPIN database contains data from Nordic countries on the use of
substances in products (http://www.spin2000.net) and was used when no data were found in IUCLID, applying an
extrapolation factor to derive a European tonnage. Use patterns were applied to
generate release indices. When several uses were possible, the most dispersive
was selected. An exposure score was then attributed. Only 737 substances could
be assessed due to limitations in the data availability. The exposure score was combined with the
hazard score to derive a risk score, and only the 78 substances classified at
the top of the resulting matrix were selected.
2.5.2.3.
Risk ranking
The subset of 78 substances selected for
their risk score were classified using a risk ratio approach. Predicted
Environmental Concentrations (PEC) were calculated using two approaches: a
multimedia model and a tiered approach developed by ECETOC to calculate the
exposure and related risks to consumers, workers and the environment caused by
chemicals. Predicted No Effect Concentrations (PNECs) were also calculated,
using experimental data where possible. PEC/PNEC ratios were then used to rank
the substances.
2.5.2.4.
List of substances prioritised through modelling
The list of 78 substances is presented in
the following table. Some of these substances were also selected by the
monitoring based prioritisation. Table 2: List of substances prioritised
through modelling ||
2.6.
Priority hazardous substances criteria
PHS are a subset of PS that are identified
as being “toxic, persistent and liable to bio-accumulate, and other substances
or groups of substances which give rise to an equivalent level of concern” (WFD
article 2(29)). In this context, the substances identified by the following
processes and legislations are relevant:
2.6.1.
REACH Substances of Very High Concern (SVHC)
At the time of initial listing for the PS
review, 15 had been identified, 3 of them already PS; overall, in 2008 and
2009, 32 substances were proposed as SVHC, many of them already PS or PHS. Two
were not relevant to the aquatic environment. The remaining 12 substances[16] were retained on
the PS candidate list until it was decided not to consider further substances
proposed for SVHC classification on the basis of CMR properties only unless
there was evidence that the substances were relevant for the aquatic
environment. Acrylamide, Benzylbutylphthalate (BBP), 4,4`-diaminodiphenylmethane
(MDA), 2,4-dinitrotoluene, Arsenic and its mineral compounds, Chromium and its
compounds and Cobalt and its compounds were then not investigated further.
2.6.2.
Persistent Organic Pollutants (POPs) under the
Stockholm Convention
At the time of initial listing for the PS
review, 12 substances were on the POPs list and 9 more were in the process of
being added after the agreement at the Conference of the Parties in May 2009,
i.e. a total of 21 substances, 10 of them not PS. Of the 13[17] identified as
POPs by the end of 2009, only those prioritised also by other processes were
considered further, to avoid looking at substances which are not relevant for
the aquatic environment in the EU.
2.6.3.
Substances identified as Persistent,
Bio-accumulative and Toxic (PBTs) under Regulation (EEC) No.793/93
At the time of initial listing for the PS
review, 27 substances had been identified, 9 of them not PS. PBT properties
were taken into consideration in the modelling-based prioritisation. Out of the
13 PBT/vPvB substances included on the list of candidate substances in the
modelling exercise, 9 substances ranked high, one of which ranked high also in
the monitoring-based prioritisation (Tetrabutyltin compounds). Tetramethyllead
was not considered further because it is no longer produced in the EU and
because Lead and its compounds are already PS; Nitrofen was not considered
further because it is only used as an intermediate in the production of
Aminofen (CAS 14861-17-7) by only one producer and its use as a PPP in the EU
has been banned since 1988. Bis(tributyltin)oxide (TBTO) was not considered
further because Tributyltin compounds are already PS. Coal tar pitch,
distillates, pyrene fraction had already been de-listed from the
monitoring-based prioritisation on the grounds that PAHs are already PS.
2.7.
Other sources for identification of candidates
for prioritisation
Annex III to the EQSD identifies 13
substances that the Commission was required to review to decide whether to
propose them for inclusion in the PS list. The consideration of these
substances is described in more detail in section 2.9. In addition, Member States and stakeholders
in WG E were given the opportunity to identify and provide the evidence of
additional substances of concern that were causing pollution problems, likely
putting at risk the achievement of the WFD objectives, and that were not being
considered through any of the prioritisation routes. The following substances
were proposed: ·
Germany proposed consideration of PFOS (already
considered) ·
Sweden proposed consideration of Irgarol (active
substance Cybutryne) ·
The EEB, supported by several Member States,
proposed consideration of seven pharmaceuticals (including some with endocrine
disruptive properties). Technical reports and literature references
were provided. It was decided that detailed dossiers would be prepared for all
of these.
2.8.
Approach to shortlisting
2.8.1.
Short-listing from the first candidate list
The initial lists from the above
prioritisation processes were amalgamated to produce a list of a few hundred
candidate substances. Further short-listing was achieved by applying of a
number of selective criteria, most of them already mentioned under the
individual headings above. The short-listing was undertaken by the Sub-Group on
Review. Efforts were made to consider all the available evidence when deciding
on whether to take forward each substance. The selective criteria were, in summary, as
follows: ·
Substances ranking high or very high in the monitoring-based
prioritisation for which the ranking was due to data from less than 3 countries
for the determinant fraction were excluded because their selection was deemed
non-representative. This led to the exclusion of 14 substances. ·
No further investigation was undertaken of PPPs/biocides
that had been authorised under the PPP legislation, but which had not been
prioritised by any other process; or that had been subject to a non-inclusion
decision under Directive 91/414/EEC or Directive 98/8/EC and did not
rank high in any of the ranking exercises. This step led to the exclusion of
168 substances from further investigation. ·
Substances that were identified due to
assessments under the existing chemicals Regulation (EEC) No.793/93/EC, were
generally not considered further if the conclusion (iii) in the risk assessment
report regarding risks to or via the aquatic environment was reached for a
local scenario or for only a few sites, and the scenario was not likely to be
present in a significant number of river basins in the EU. Out of the 49
substances with conclusion iii for the aquatic environment, 12 were further
investigated. ·
Voluntary risk assessments on copper and on
PFOS, for which the results showed conclusion (iii) for aquatic environment for
some scenarios and uses, led to further consideration of those substances. ·
No further investigation was undertaken of REACH
SVHC for which the reason to propose this classification was their CMR
properties alone, i.e. for which there was no other source of prioritisation
that showed that exposure through water was relevant. This meant that 7
substances that had been identified were not further investigated. ·
No further investigation was undertaken of POPs
where there was no other source of prioritisation. ·
To arrive at a manageable list, the 10
highest-ranking substances from the monitoring and modelling-based
prioritisation processes were selected, along with the substances identified
for further review from the risk assessment reports, as well as the substances indentified
from the other sources (PBTs, SVHC, POPs, Annex III lists). Some substances
were selected based on more than one criterion. A list of 51 substances for preparation of
dossiers was arrived at and proposed to the Sub-Group on Review. To this list were
added the 8 substances (Cybutryne and 7 pharmaceuticals) proposed as substances
of concern to Member States, resulting in a shortlist of 59 substances (or
groups of substances). Discussions within the Sub-Group at its
meeting in January 2010 led to the elimination of 15 of these substances or
groups of substances for a range of reasons, e.g. because: ·
the risk assessment report identified risks to
the aquatic environment, but sufficient risk reduction measures had been
implemented and there was evidence they were effective at local level. ·
it appeared that risks to or via the aquatic
environment were likely to be local only and best handled at national level. ·
industry provided new data on production volumes
that led to lower ranking in the modelling-based prioritisation exercise. Heptachlor and Heptachlor epoxide, the two
isomers of HBCDD and 17 alpha-ethinylestradiol and 17 alpha/beta estradiol were
considered together for the preparation of dossiers, meaning that there was a
short-list of 41 dossiers to be prepared for detailed review.
2.8.2.
Preparation of substance dossiers and further
short-listing
For the 41 short-listed substances or
groups of substances, substance-specific data sheets (substance dossiers) were
prepared to facilitate further discussion and detailed review. A template for
these was agreed by the Sub-Group. Member State volunteers or the Commission
consultant INERIS were tasked with acting as rapporteur for individual
dossiers, and consulted closely with associated MS and stakeholders. The dossiers
collated available information on the identity, regulation/legislation,
properties, environmental occurrence, and toxicity of the substances. Once the dossiers had been prepared, the
Sub-Group met to consider which substances it should recommend for EQS
derivation and inclusion in the revised PS list. A summary document was
prepared to structure and facilitate the discussions, including to highlight
areas of uncertainty or contention including points that had been flagged by
rapporteurs or associated MS/stakeholders. From the 41 substances or groups of
substances, the Sub-Group arrived at a short-list of 20 substances for further
consideration, 16 of which they recommended for EQS derivation, 3 of which they
considered required further information before a recommendation could be made,
and one of which should be considered under the review of the existing PS. On
the remaining substances they concluded that there was not sufficient evidence
to take them forward in the current review. The criteria used to decide on each
substance were their toxic properties and/or available PEC/PNEC ratios. If a
substance was either PBT/vPvB/ED/CMR and/or the PEC/PNEC ratio was >=1, it
was generally recommended for EQS derivation, unless its regulatory situation
suggested this might or would not be necessary. Conversely, if a substance was
not PBT/vPvB/ED/CMR and did not have a PEC/PNEC ratio >=1, it was generally
put aside. More information was judged necessary on 17
beta-estradiol, ibuprofen and zinc for the following reasons. An industry study on the PNEC for 17
beta-estradiol was due in the near future that should be considered before
concluding that the PEC/PNEC ratio was >1. The industry study was delivered
and did not change the conclusion. Therefore, the substance was finally taken
forward for EQS derivation. On Ibuprofen, the SCHER was asked whether a
particular study that had been used as a key study to derive a tentative EQS could
be used as sufficient basis for the EQS. The SCHER's response was that other
supporting studies were needed, and therefore Ibuprofen was not proposed for
prioritisation. On Zinc, further analysis of the monitoring
data (and risk ratios) was considered necessary. This was performed and
presented to the WG E. On this basis, a survey was performed among Member
States experts that concluded that a large majority did not support the
prioritisation of Zinc at this stage. The results of the assessment of the
monitoring data were not conclusive because subject to a significant degree of
uncertainty, arising from three main sources: ·
The fact that most of the monitoring data were
for total Zinc, instead of dissolved Zinc as required for the risk assessment ·
Monitoring data on the supporting
physico-chemical parameters needed for the estimation of bioavailability were
not available. Default parameters had to be used which introduced a significant
degree of uncertainty. ·
Information on natural background concentrations
was scarce. On this basis, it was decided not to pursue
the prioritisation of Zinc but to gather monitoring data of better quality for
the purpose of risk assessment and refine the analysis in a future review of
the list of priority substances. Although Zinc is not proposed for
prioritisation, an EQS was derived for it (and assessed by the SCHER) which
could be used by MS as a national standard, thus improving harmonisation. EQS fact sheets (EQS dossiers) based on the
substance dossiers were prepared for 19 substances (the 17 indicated in Table 3
as "recommended for EQS derivation" plus Zinc and Ibuprofen, the
latter only including a tentative EQS). The EQS derivation process is described
in detail in section 3 of the present document. In the process of development of the EQS
dossiers, discussions took place about the reliability of the monitoring
information on Cyanides. Most of the available monitoring data were for total Cyanides,
whereas the toxicity data on the basis of which a PNEC had been derived were for
free Cyanide (the form listed in Annex III of the EQSD). The conclusion of the
discussions was that free Cyanide would not be proposed for prioritisation in
this review. As for Zinc, further review of free Cyanide would benefit from the
collection of targeted high-quality monitoring data. For this reason, both
substances are candidates for inclusion in the proposed watch list. Of the 19 substances shortlisted for EQS
derivation, 16 appear in the proposal, although two are together, i.e.
Dioxin-like PCBs are included with Dioxins. Non-dioxin-like PCBs are not
included, on the grounds that there are insufficient data to reliably set an
EQS. Table 3 summarises the outcome of the
discussions on the 41 dossiers. Table 3: Outcome of expert discussion on
the short-list of 41 dossiers Substance || Lead Recommended for EQS derivation || 17 alpha-ethinylestradiol (EE2) || COM 17 beta-estradiol (E2) || COM Aclonifen || COM Bifenox || COM Cyanide – free (HCN and CN-) || COM Cybutryne (Irgarol®) || SE Cypermethrin || NL Dichlorvos || COM Diclofenac || DE Dicofol || COM Dioxin (2,3,7,8 - Tetrachlorodibenzo-p dioxin,TCDD) || IT Heptachlor/Heptachlor epoxide || COM 1,2,5,6,9,10-Hexabromocyclododecane (HBCDD) 1,3,5,7,9,11-Hexabromocyclododecane (HBCDD) || SE Perfluorooctane sulfonic acid and its salts (PFOS) and perfluorooctane sulfonyl fluoride || UK Polychlorinated biphenyls (PCBs) || FR Quinoxyfen || COM Terbutryn || DE To be considered under the review of existing PS || Diphenyl ether, octabromo (octaBDE) || SE Not enough evidence to take forward at present || Amino-methyl phosphonic acid (AMPA) || FR Bentazone || IT Bisphenol A (4,4'-isopropylidenediphenol) || UK Carbamazepin || DE Chlorothalonil || NL Chromium trioxide || UK Clarithromycin || DE Cyclododecane || SE Dichlofluanid || COM Edetic acid (EDTA) || COM Glyphosate || FR Ibuprofen || DE Mecoprop (MCPP) || UK Musk xylene || AT Omethoate || COM Propiconazole || DE Sulfamethoxazole || DE Tolylfluanid || FI Tri-allate || UK Trichlorfon || FR Zinc and its compounds || UK
2.9.
Annex III of EQSD substances
All 13 Annex III substances were
incorporated in the modelling-based prioritisation. Monitoring data was also
available for a number of the substances and the results of the
monitoring-based prioritisation approach for those are presented in the INERIS
Monitoring report in section VIII.3. Only a few Annex III substances were not
already proposed for further consideration by other prioritisation processes. The outcomes of the individual
prioritisation processes and the conclusion of the overall prioritisation
process regarding each of the Annex III substances are presented in Table 4. Table 4: Conclusions of the individual and
overall prioritisation processes regarding the Annex III substances CAS || Substance || Conclusion 57-12-5 || Cyanides (free) || Ranked very high in the monitoring based prioritisation. Risk ratio >1. Selected for EQS derivation but monitoring data largely for total rather than free cyanide, therefore not prioritised. Probable candidate for the proposed watch list. 60-00-4 || Edetic acid (EDTA) || Risk assessment conclusion iii for aquatic environment, but evidence suggested risk ratio generally <1. Not selected for EQS derivation: 80-05-7 || Bisphenol A (4,4'-isopropylidenediphenol) || 2008 update of the risk assessment concluded no risk to aquatic environment. Outstanding controversy regarding effects on snails. Not selected, but evidence to be reviewed. 81-15-2 || Musk xylene (5-tert-buthyl-2,4,5-trinitro-m-xylene) || Ranked high in modelling based prioritisation, PBT, SVHC. Insufficient evidence of a risk ratio>1. REACH Annex XIV listing will further reduce. Not selected. 115-32-2 || Dicofol || Ranked high in both monitoring and modelling based prioritisation, PBT, recommended as POP. Selected for EQS derivation. 1066-51-9 || Amino-methyl phosphonic acid (AMPA) || Identified in the INERIS report as potentially responsible for failures in the drinking water standard. Insufficient quantitative evidence of failure. Not selected. 1071-83-6 || Glyphosate || Identified in the INERIS report as potentially responsible for failures in the drinking water standard. Insufficient quantitative evidence of failure. Not selected. 1336-36-3 || Polychlorinated biphenyls (PCBs) || Ranked very high in the monitoring based prioritisation, PBT, POP. Selected for EQS derivation (but EQS derivation possible only for dioxin-like PCBs, along with dioxins; not enough data for non-dioxin-like PCBs) 1746-01-6 || Dioxin (2,3,7,8 - Tetrachlorodibenzo-p dioxin,TCDD) || Ranked very high in the monitoring based prioritisation, POP. Selected for EQS derivation. 1763-23-1 || Perfluorooctane sulfonic acid and its salts (PFOS) and perfluorooctane sulfonyl fluoride || Voluntary risk assessment identified risk to aquatic environment, PBT, POP. Selected for EQS derivation. 7085-19-0 || Mecoprop (MCPP) || Inclusion decision (PPP Directive Annex I) does not indicate the need to take measures to limit the risk to the aquatic environment. Risk ratio < 1. Concern re failures in drinking water not supported by sufficient quantitative evidence. Not selected for EQS derivation. 25057-89-0 || Bentazon || Inclusion decision does not indicate the need to take measures to limit the risk to the aquatic environment. Risk ratio < 1. Concern re failures in drinking water not supported by sufficient quantitative evidence. Not selected for EQS derivation. 124495-18-7 || Quinoxyfen || Inclusion decision indicates the need to take measures to limit the risk to the aquatic environment. Isolated exceedance of tentative EQS but PBT properties. Selected for EQS derivation. Detailed dossiers were prepared for all
Annex III substances because of the explicit obligation in the EQS Directive to
review them.
2.10.
Approach to substances that might pose a
specific risk to drinking-water supplies
In the monitoring-based ranking the PECs
were compared with the drinking water standards. Raw water in the environment
is not expected to comply with drinking water standards as water is treated
before being distributed, and therefore some pollutants are removed. However,
the review tried to identify substances for which the ratio between the PEC and
the drinking water standard was particularly high, i.e. to identify substances
for which high treatment removal efficiency would be necessary, and which might
thus cause failure of the drinking water standard at the tap. The substances ranking high in this
approach to prioritisation, and the estimated treatment removal necessary to
achieve the drinking water standard are presented in Table 5. Table 5: Conclusions of the
monitoring-based ranking regarding substances that might pose a risk to
drinking water supplies CAS || Substance Name || EQSD Annex III subst. || Estimated removal efficiency needed 7664-41-7 || Ammonium compounds || || 99,96-99,97 100-00-5 || 1-Chloro-4-nitrobenzene || || 80-98 1066-51-9 || Aminomethylphosphonic acid (AMPA) || X || 89-92 1071-83-6 || Glyphosate (incl trimesium aka sulfosate) || X || 69-84 1698-60-8 || Chloridazon || || 30-99,7 34123-59-6 || Isoproturon || || 49-76 59-50-7 || 4-Chloro-3-methylphenol || || 31-60 75-01-4 || Chloroethylene || || 86-99 7440-61-1 || Uranium || || 96-97 It should be noted that this was a
theoretical exercise as no information was available on whether the high
concentrations were found in water bodies actually used or intended to be used
in the future for the abstraction of drinking water. For this reason,
additional information was requested from Member States and the drinking water
industry, in particular regarding whether exceedances of the drinking water
standards occur that are linked to elevated concentrations of these or other
substances in water bodies. The information received was not conclusive in
terms of the EU-wide representativeness of the problem. Therefore, no substance
was proposed for prioritisation on this basis.
3.
Environmental Quality Standards (EQS) derivation and
revision
For all the substances proposed for listing
in the revised PS list it was necessary to derive environmental quality standards
(EQS) for inclusion in the amended EQS Directive. On the basis of new evidence,
the EQS for some existing substances had to be revised. The principles for setting EQSs are set out
in Section 1.2.6 in Annex V of the WFD but the details necessary for practitioners
to follow are lacking. The derivation and revision of
EQS in the current review were done on the basis of updated guidance, produced
as explained below. Although there is no formal obligation to follow the
guidance, it presents best practice for EQS derivation.
3.1.
Technical Guidance on Environmental Quality
Standards derivation (TGD EQS)
For the first list of PS, EQS were
established in EQSD on the basis of extensive technical work using the Manual
on the Methodological Framework to derive Environmental Quality Standards for
Priority Substances under the WFD prepared by the Fraunhofer Institute[18].
The work was supported by an Expert Advisory Forum established in 2001. For the
present review it was necessary to update the guidance. The main elements of
the update were identified on the basis of the 2004 opinion[19]
of the Scientific Committee on Toxicity, Ecotoxicity and the Environment on the
former guidance and on discussions among the Commission, Member States and
stakeholder experts. An Expert Group (EG-EQS) under WG E
co-chaired by the JRC and the UK was established to update the guidance, which
covers all receptors (humans, aquatic life, predators) and all media (water,
sediments and biota) that might be put at risk from chemical pollution. The updated
guidance builds on the earlier guidance but provides more detail in a number of
important areas, e.g. how to deal with metals, and how to derive EQSs for
sediment and biota. It also includes more detailed guidance on other aspects of
standard setting that were not covered in the earlier document. It addresses all the points raised by
CSTEE, not only regarding metals, sediments and biota, but also for example
regarding the derivation of EQSs for transitional and coastal waters, the
reliability and relevancy of the data used to derive EQS, the use of higher
tier assessment methods and data such as Species Sensitivity Distributions
(SSDs) and mesocosm study data in the derivation of short-term exposure
standards, i.e. MAC-EQS, consideration of uncertainties, and the objective of
protecting human health. EG-EQS also sought to address technical
issues highlighted in a paper by Bonnomet and Alvarez to the Expert Advisory
Forum (8) in 2006, and to incorporate recent scientific thinking in the
development of environmental standards e.g. those highlighted in a SETAC
technical workshop held in the UK in 2006. Since the guidance on EQS setting in Annex
V of the WFD refers to guidance developed for Existing Substances and Biocides,
part of the brief to the EG-EQS was to be consistent, as far as practicable,
with guidance developed for REACH. The updated guidance highlights the role of
existing risk assessments, e.g. those conducted under the PPP legislation, in
setting EQSs. The updated guidance was submitted to the Scientific
Committee on Health and Environmental Risks (SCHER) for its opinion. The SCHER
was largely supportive of the guidance, including of its handling of metal
bioavailability. The TGD-EQS was slightly revised in response to specific
comments, but the changes in the guidance did not affect significantly the
methodology for EQS setting, and consequently did not affect the EQS that were
already being developed on the basis of the draft updated guidance. A number of
observations by the SCHER will be addressed in the longer term in future
revisions of the guidance. The final updated TGD-EQS was endorsed by
the Water Directors of the Member States in May 2011.
3.2.
Derivation of EQS for Proposed Priority
Substances
As indicated above, EQS fact sheets (EQS
dossiers) were prepared for 18 substances or groups of substances (the 19
shortlisted, excluding ibuprofen, for which only a tentative EQS was developed
as a basis for the consultation with SCHER). The rapporteurs were in some cases
different from those which prepared the original substance dossiers. The
template was the same as that for the substance dossiers; the sections related
to the EQS were revised or completed for the first time. Information extracted from grey literature
was reported in the EQS dossiers where necessary and/or relevant but European
and international peer-reviewed sources of information were given priority
(e.g. European risk assessments for existing substances, PPPs and biocides, PBT
evaluations, US-EPA assessments). The EQS dossiers were considered initially
by the associated Member States and stakeholders, then by the Sub-Group on
Review as a whole. In most cases agreement on the proposed EQS was reached.
However, in some cases, divergent views remained. The EQS dossiers were
submitted to the SCHER for its opinion, in particular as to whether the EQS
have been correctly and appropriately derived, in the light of the available
information and the TGD-EQS, and whether the most critical EQS (in terms of
impact on environment/health) has been correctly identified. Divergent views in the Sub-Group were
highlighted in the requests to the SCHER. As explained above, in the case of
ibuprofen, a critical but disputed study rather than an EQS dossier was
submitted for an opinion on its relevance for EQS setting. The dossier for the
non-dioxin-like PCBs was not submitted because there were not enough data to
reliably derive an EQS. In response to the SCHER opinion on
aclonifen, the decision was taken not to designate it as a PHS, despite views
to the contrary from the Sub-Group. The SCHER's comments on the cypermethrin
dossier led to a check of the cited data and a number of corrections to
citations but not to any change in the EQS, since the errors identified by the
SCHER were not critical to the conclusions. The dicofol dossier was reviewed
and some corrections made leading to an approximately 4-fold increase in the
biota standard and corresponding (back-calculated) water EQS. In the EE2 and E2
dossiers, the marine annual average quality standards (AA-QS) were doubled as a
result of adjusting the additional assessment factor from 10 to 5. Additional
information and/or explanation was added to a number of the other EQS dossiers,
most notably the dioxins dossier, but no other changes were made to EQS. For diclofenac,
SCHER's opinion suggested that until there is greater certainty about the
magnitude of a biota EQS, the water EQS should be considered the critical EQS;
this will have to be reviewed. Similarly, a better acute toxicity dataset
should in due course allow a Maximum Allowable Concentration (MAC) to be set. In most of the dossiers, explanation has
been added regarding the application of an additional assessment factor for the
marine compared with the freshwater EQS. The additional assessment factors (not
always 10) have been applied according to the revised TGD-EQS referred to
above. The guidance, which is consistent with the approach under REACH, states
that: the assessment factors provided for
deriving the marine water QS are higher than those used for freshwater and that
"this is justified by the need to account for the additional uncertainties
associated with extrapolation for the marine ecosystem, especially the general
under-representation in the experimental dataset of specific marine key taxa
and possibly a greater species diversity". The guidance provides criteria
for diverging from the provided default assessment factors. These criteria
were used to determine the assessment factors and therefore the marine water QS
for the substances in the PS review on a case-by-case basis.
3.3.
Revision of EQS for Existing Priority Substances
Members of the Working Group E (WG E) were
asked to indicate whether the EQS for any existing PS should be revised on the
basis of new scientific information, and to comment on the need for standards
in environmental compartments other than those for which they were already
available. In addition, a systematic check was made of any updates to European
risk assessment reports on existing PS (under the chemicals, biocides and PPP
legislation). On the basis of the findings, it was
decided that the EQS for following substances should be reviewed. Table 6: Rationale for reviewing EQS of
existing PS Existing substance || Rationale for reviewing EQS Anthracene, Fluoranthene, Naphthalene, PAH 5-6 rings || New information (Final EU RAR for Coal Tar Pitch, High Temperature, 2008) Benzene || New information (Final EU RAR 2008) and Member State concern about carcinogenicity Polybrominated diphenyl ethers || To include octaBDE (prioritised in the prioritisation process) Lead || New information (EU VRAR 2008, SCHER review of VRAR 2009, first draft of Chemical Safety Report for REACH registration) and need to consider bioavailability Mercury || Concern about the biota matrix to be monitored Nickel || New information (EU RAR 2008, SCHER review of RAR 2009, and additional industry studies related to REACH registration) and need to consider bioavailability The EQS for most of these substances were
therefore revised according to the updated TGD-EQS, and the dossiers were
submitted to the SCHER for its opinion. For the substances reviewed in the light of
the final RAR for Coal Tar Pitch, the new information led to the conclusion
that for fluoranthene and four of the PAHs (i.e. excluding
benzo(g,h,i)perylene, the critical matrix was biota. The Sub-Group proposed,
for the four PAHs, use of the established food standard based on the toxicity
of benzo(a)pyrene. This would also cover the risk from the non-carcinogenic
PAH. For polyBDEs a biota standard was also proposed. In all these cases,
calculation of a corresponding water standard led to values lower (in some
cases much lower) than the existing water standard. For this reason, and
because the back calculation is subject to some uncertainty, use of the biota
standard appears appropriate. The SCHER's comments led to review of the
above EQS dossiers and some changes were made. In the anthracene and fluoranthene
dossiers, the AA-QS for marine sediment were adjusted by eliminating the
additional assessment factor of 5. In the naphthalene dossier, explanation was
added for the choice of methodology and the retention of different assessment
factors for the freshwater and marine sediment AA-QS. In the polyBDEs dossier,
explanation was added for the choice of indicator congeners. For benzene, industry brought new
epidemiological and exposure information to the Sub-Group on Review, and it was
concluded that the review would not be pursued further at this stage as there
was no clear case for it. For lead and nickel, the revision led to
standards for the bioavailable metal. In the 2006 Commission proposal, these
two standards were highlighted as preliminary, as the risk assessments were at
the time not finalised. The SCHER opinion on the lead dossier prompted the
addition of some clarifications, and the selection of an assessment factor of 4
for the freshwater and marine sediment EQS, allowing presentation of a single
value for each EQS rather than a range. The SCHER opinion on the nickel EQS
dossier prompted additional in-depth and independent statistical analysis of
some higher-tier data. There was a difference of opinion among the experts
involved. For mercury, a review of a large number of
studies on secondary poisoning was undertaken by INERIS and made available to
the SG-R. This work supports the use of fish as the main biota matrix for
monitoring. For 11 other substances, relevant updated
risk assessments were identified, but a closer review led to the conclusion
that revision of the EQS was not necessary at this stage.
4.
Priority Hazardous Substances (PHS) status
4.1.
Definition and criteria
"Hazardous substances" are
defined in the WFD as substances or groups of substances that are toxic,
persistent and liable to bio-accumulate, and other substances or groups of
substances which give rise to an equivalent level of concern. Article 16 of the
WFD determines that for Priority Hazardous Substances (PHS) measures should be
aimed at the cessation or phasing-out of discharges and emissions and losses to
the aquatic environment. For the first list of priority substances
(PS), the classification of PS as PHS was based largely on the PBT criteria
listed in the Technical Guidance Document on Risk Assessment (ECB)[20]
and in the proposal for the REACH Regulation. The classification of the 33 PS
was done in two stages, i.e. 11 were classified definitely as PHS already in
Decision 2455/2001/EC, but 14 were classified as possible PHS, subject to
review – see Commission Working Document ENV 191000/01 final[21].
The procedure proposed was to group the PS according to their level of concern,
taking particular account of their level of hazard. Reference was made to
hazard classifications under other legislation, e.g. OSPAR Strategy, Council
Directive 67/548/EEC, POPs Protocol under the UN-ECE CLRTAP, EU-RARs under
Regulation (EEC) No. 793/93 and Council Directive 76/464/EEC and its five
daughter directives. After grouping the substances, additional considerations
were taken into account, including other relevant Community legislation or
relevant international agreements, the production and use of the substance and
the suspected endocrine disrupting potential of the substance. In 2006, for the proposal on the EQS
Directive, a further document setting out a list of characteristics that would
justify PHS classification, including characteristics giving rise to an
equivalent level of concern, was developed[22]. For 14 PS
under review at that stage, it was agreed to assess the aspect of “equivalent
concern” on a case-by-case basis with the application of expert judgement and
by ensuring, wherever possible, coherence with other relevant Community
legislation. Decisions were made to confirm 9 of the 14 tentative PHS
designations, such that 20 PS were finally designated as PHS. The criteria for
equivalent concern were: a) Very Persistent, Very Bioaccumulative
(vPvB)-criteria; b) Persistent Organic Pollutants (POP) (cf.
Stockholm Convention); c) Carcinogenic, mutagenic and toxic for
reproduction (CMR); d) Very Persistent, Very Toxic (vPvT) for
substances with a high mobility; e) Targeted risk assessments showing a
particular risk for parts of the aquatic environment (in particular marine and
groundwater). Since that 2006 review, the REACH
Regulation has become operational. The PBT criteria are laid down in Annex
XIII, and there is a growing list of Substances of Very High Concern -
SVHC as defined in Article 57 of REACH - which may be included in
Annex XIV of the Regulation and thus become subject to authorisation. It is reasonable, in view of Recital
28 of the EQSD and Article 2 (paragraphs 29 and 30) of the WFD, to
harmonise the WFD approach with the approach taken under REACH, and therefore
to use, as bases for identifying PHS, the criteria in REACH Annex XIII and
Article 57 relating to PBTs and substances posing an equivalent level of
concern. However, not all SVHC under REACH necessarily qualify as PHS,
since not all are relevant to the aquatic environment, nor should the REACH
criteria be considered exclusive, since REACH is not the main legislation for
all chemicals (for example substances used in Plant Protection Products and
pharmaceutical products are exempted from REACH authorisation), and its
concerns do not necessarily encompass all the concerns arising under
the WFD. Although substances having endocrine
disrupting properties are covered in Article 57(f) of REACH, the Commission is
currently developing criteria to assess endocrine disrupting substances and
their properties, and for this reason, no attempt is being made during this
review to classify proposed PS as PHS on the basis of their endocrine
disrupting properties alone. The outcome of the Commission work is expected in
2013.
4.2.
Review
4.2.1.
Changes to existing Priority Substances
A questionnaire to members of Working Group
E regarding whether there was new evidence that would provide grounds to
reclassify some existing PS as PHS led to a number of suggestions. The
technical grounds given were assessed by the Sub-Group on Review of the
Priority Substances List (SG-R). Of the five existing PS reviewed, two are
proposed for possible reclassification to PHS, i.e. DEHP and Trifluralin. Tables 7(a)-(e) summarise the evidence
considered and the conclusions of the present review. Table 7(a) PS No.12: Di
(2-ethylhexyl)-phthalate (DEHP) Conclusion of previous review || PBT criteria not met, though some borderline Widespread in environment, therefore humans exposed through whole lifetime These points might justify “equivalent level of concern” but EAF judged that there was not sufficient evidence of concern Some MS in favour of PHS status but no additional evidence provided Technical grounds for PHS status || Reprotoxic. Cat IB in Annex VI Table 3.1 (harmonised classification and labelling of hazardous substances) of Regulation (EC) 1272/2008 (CLP) based on criteria in Annex I of the Regulation; Cat 2 in Annex VI Table 3.2 based on criteria in Annex VI of Directive 67/548/EEC. DEHP bioaccumulates in aquatic organisms. The BCF is =<2700, being 840 in fish and 2500 in mussels. The EU risk assessment (RAR, 2008, http://esis.jrc.ec.europa.eu/doc/existing-chemicals/risk_assessment/REPORT/dehpreport042.pdf) suggests need to limit risk of secondary poisoning in relation to food chains based on aquatic organisms, especially mussels, and a need to limit the risks to children in relation to exposure via the environment (taking account of existing risk reduction measures). Identified as substance of very high concern (SVHC) under REACH and listed in Annex XIV due to toxicity for reproduction, see: http://echa.europa.eu/doc/authorisation/annex_xiv_rec/subs_spec_background_docs/dehp.pdf#search="DEHP" and http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:044:0002:0006:EN:PDF Detected in sediment and biota in remote areas in southern Norway: http://www.klif.no/publikasjoner/2284/ta2284.pdf page 63. Technical arguments against PHS status (CEFIC - ECPI) || Not PBT (RAR for under Regulation (EEC) No 793/93) Not PBT and not a risk for the marine environment at present exposure (OSPAR 2008) Reprotoxicity under Directive 67/548/EEC in place since 2001; not supported by Caunter et al 2004 study reviewed in RAR In REACH candidate list because of existing toxicity classification; all evidence will be reviewed; recent papers indicate that the exposure of children is similar to that of adults and the Margin of Safety means there is no need for concern Site-specific concentrations show no secondary poisoning risk Detection in sediment and biota at remote locations not a reason for PHS status (concentrations not a risk to aquatic organisms) COM WG on CLP concluded not dangerous to the environment Environmental concentrations are decreasing Biodilution (rather than biomagnification) occurs up the food chain. Conclusions on the technical grounds || Appropriate to list as PHS given conclusions in the RAR and the inclusion of DEHP in Annex XIV of REACH (SVHC). The RAR (post-dating the COM WG on CLP) concluded that there was no concern for aquatic species exposed via the water phase, but that there was a need to limit the risk of secondary poisoning and the risks to children in relation to exposure via the environment (taking account of existing risk reduction measures). Table 7(b) PS No. 20: Lead and its
compounds Conclusion of previous review || PBT assessment of metals difficult; in particular, P assessment not possible Comparison with Hg and Ni led to conclusion that there was not sufficient evidence that Pb posed an equivalent level of concern Technical grounds for PHS status || Repr. 1A (H360: May damage fertility or the unborn child.) according to CLP for Pb compounds, some exceptions; and according to REACH self-classification for Pb metal powder, inorganic Pb compounds Carc 2 – according to REACH self classification for inorganic Pb compounds; IARC Carc 2A - on basis of 2B plus limited epidemiological evidence Damaging to IQ – threshold level for neurodevelopmental effects cannot be identified (methodological limitations?) Recent SCHER opinion on lead in drinking water[23] states that it sees no scientific basis for an increase in the drinking water standard for lead; a decrease in lead intake would reduce risk. Technical arguments against PHS status (ILA-E) || Not PBT Pb metal and inorganic Pb not expected to be mutagenic under normal use and handling. (Note: data inconsistent, questions re relevance of exposure route/concentrations to in vivo circumstances) Insufficient epidemiological evidence to indicate that inorganic lead or lead compounds pose human cancer risk at most tissue sites studied. Conclusions on the technical grounds || Conclusion that exposure of humans via surface waters minor in comparison with other routes, therefore not PHS despite intrinsic properties. Table 7(c) PS No. 26: Octylphenol Conclusion of previous review || Fulfils P and T criteria, not B No equivalent level of concern identified Technical grounds for PHS status || Endocrine disruptive and same level of concern as nonylphenol (already PHS). Technical arguments against PHS status (CEFIC - CEPAD) || OP is an intermediate, not remobilised from the final resin Current EQS (0.1 μg/l) conservative, cf REACH PNEC (0.632 μg/l) Environmental concentrations low; few exceedances of EQS; case-by-case management appropriate Reprotox study in rats (ref to be added) – no evidence of effects EQS is protective for endocrine effects (literature review) Presence of OP in NP not higher than approx 1% Conclusions on the technical grounds || (No conclusion for the moment: ED criteria being developed by COM.) Table 7(d) PS No. 31: Trichloro-benzenes Conclusion of previous review || Lowest NOECs > T threshold, but uncertainty re mammalian toxicity Potential for long-range transport List I substance under Dir 76/464/EEC RAR under Reg (EEC) No.793/93 identified risks BUT, the Commission recommended that TCBs not be designated as PHS until the criteria for establishing 'an equivalent level of concern' were agreed and it could be demonstrated that the criteria are met by this substance. Technical grounds for PHS status || PBT (Identified as PBT by the Technical Committee New and Existing Substances (TC NES) Subgroup on identification of PBT and vPvB Substances, EC). Proposed for investigation as POPs. Technical arguments against PHS status (CEFIC - EuroChlor) || Does not satisfy PBT criteria. (van Wijk D et al (2006) 1,2,4-Trichlorobenzene marine risk assessment with special emphasis on the Osparcom region North Sea. Chemosphere 62, 1294-1310) Not placed on REACH candidate list in 2010 because not identified as PBT Existing restrictions under Directive 2005/59/EC and registration only as intermediate under REACH mean little possibility of emission to aquatic environment Conclusions on the technical grounds || Not a PBT; POP proposal apparently withdrawn. Not PHS. Table 7(e) PS No. 33: Trifluralin Conclusion of previous review || Fulfils B and T criteria but not P No equivalent level of concern identified Technical grounds for PHS status || PBT (Identified as PBT by the TC NES Subgroup on identification of PBT and vPvB Substances, EC, 2006). Probable POP (Identified as fulfilling POP screening criteria by the TC NES Subgroup, EC, 2006; considered by EU delegation to UNECE CLRTAP Executive Board December 2010 to warrant POP designation.) Technical arguments against PHS status (Dow Agro-Sciences) || PBT criteria not fulfilled in any single environmental compartment. CLRTAP process ongoing; conclusions on persistence should not be drawn until decision made. The Task Force (June 2010) "was not able to reach a consensus on trifluralin as a POP in the context of the Protocol…". At the Executive Board (December 2010) "it was suggested that the Working Group on Strategies and Review should consider any new scientific information with regard to trifluralin and/or PCA/PCP that might be submitted in time for its forty-ninth session in September 2011" Conclusions on the technical grounds || PBT criteria met even if POP designation not confirmed. (P criterion for PBT is less stringent than for POP, i.e. 120d cf 180d in soil; PBT criteria do not have to be met in single compartment.). PHS.
4.2.2.
Proposed new Priority Hazardous Substances
Table 8 summarises the conclusions of the
present review. Table 8: Proposed PHS Substance || Rationale for PHS status Dicofol || CLRTAP Working Group on Strategies and Review (Sept 2010) has recommended listing in POP protocol. Suspected to be endocrine disruptive. Dioxins and Dioxin-like PCBs || Fulfils PBT criteria. Several congeners show endocrine disruptive properties. One congener carcinogenic. PFOS || PBT; POP since August 2010. Reprotoxic (Cat 2) HBCDD || CLRTAP Working Group on Strategies and Review (Sept 2010) has recommended listing in POP protocol Heptachlor/Heptachlor epoxide || Fulfils PBT criteria. Suspected to be endocrine disruptive. IARC Group 2b – possibly carcinogenic to humans. Quinoxyfen || Fulfils PBT criteria.
5.
Technical background documents
Technical background documents listed below
are available at: http://circa.europa.eu/Public/irc/env/wfd/library?l=/framework_directive/thematic_documents/priority_substances/supporting_substances The following documents are included: ·
Results of the monitoring-based prioritisation: INERIS-International Office for Water.
Implementation of requirements on Priority substances within the Context of the
Water Framework Directive (contract 07010401/2008/508122/ADA/D2).
Prioritisation process: Monitoring-based ranking (September 2009). ·
Results of the modelling-based prioritisation: K. Daginnus, S. Gottardo, A.
Mostrag-Szlichtyng, H. Wilkinson, P. Whitehouse, A. Paya-Pérez and J. M.
Zaldívar (2010). A modelling approach for the prioritisation of chemicals under
the Water Framework Directive. JRC Scientific and Technical Report EUR 24292
EN. http://publications.jrc.ec.europa.eu/repository/bitstream/111111111/13548/1/prioritization_eur_february10_final.pdf
·
Methodology for deriving EQS Common Implementation Strategy for the
Water Framework Directive (2011). Guidance document No 27. Technical Guidance for
Deriving Environmental Quality Standards. ·
EQS dossiers 23 substance specific dossiers summarising
the derivation of the EQS. ·
SCHER opinions on the Technical Guidance
document and the EQS dossiers The scientific opinion on the Technical
Guidance for Deriving EQS and 24 scientific opinions on the EQS for the
individual substances are available at: http://ec.europa.eu/health/scientific_committees/environmental_risks/opinions/index_en.htm#id10
·
Source screening and measures sheets Updated source screening and measures
screening sheets for the existing 33 PS and for 19 candidate PS ·
Study supporting the impact assessment Entec UK Ltd. Technical Support for the
Impact Assessment of the Review of Priority Substances under Directive
2000/60/EC (Contract 070307/2009/547548/SER/D1): Interim report (methodology) (November
2010) 29 substance-specific impact reports (April
2011) Final report (including high-level
analysis) (June 2011) [1] Directive 2000/60/EC of the European Parliament and
of the Council of 23 October 2000 establishing a framework for Community action
in the field of water policy [OJ L327 of 22.12.2000]. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:02000L0060-20090113:EN:NOT [2] Directive 2008/105/EC of the European Parliament and
of the Council of 16 December 2008 on environmental quality standards in the
field of water policy, amending and subsequently repealing Council Directives
82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending
Directive 2000/60/EC of the European Parliament and of the Council [OJ L 348,
24.12.2008, p. 84–97]. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:348:0084:0097:EN:PDF
[3] Common Implementation Strategy (CIS) http://ec.europa.eu/environment/water/water-framework/objectives/pdf/strategy.pdf
[4] CIS work programme 2011-2012 http://circa.europa.eu/Public/irc/env/wfd/library?l=/framework_directive/implementation_documents/final_2010-2012/_EN_1.0_&a=d
[5] http://ec.europa.eu/transparency/regexpert/detailGroup.cfm?groupID=371,
under "Sub-groups", "Priority Substances". [6] http://ec.europa.eu/environment/water/water-dangersub/lib_pri_substances.htm
[7] Opinion on the revised proposal for a List of
Priority Substances in the Context of the Water Framework Directive (COMMPS
Procedure) prepared by the Fraunhofer-Institut (Germany) - Final report Opinion
adopted at the 11th CSTEE plenary meeting on the 28th of September 1999. http://ec.europa.eu/health/ph_risk/committees/sct/docshtml/sct_out49_en.htm
[8] The information on this section reflects the
situation at the time of performing the review (mid 2009). [9] Conclusion (iii): There is a need for limiting the
risks; risk reduction measures which are already being applied shall be taken
into account. [10] Opinion of the SCTEE adopted on 28 September 1999,
available at http://ec.europa.eu/health/ph_risk/committees/sct/docshtml/sct_out49_en.htm
[11] “Monitoring data provide an excellent basis, from
direct observation, to get information on European environmental conditions.
However, monitoring data cannot be used as the single scoring method because
the available information is incomplete and only covers a set of substances
which were considered "relevant" in the past. Thus, the current
monitoring information is biased by previous decisions on which substances
should be monitored. (…) Therefore, it is important to incorporate a second
system, to allow inclusion in the final list, of substances with a high
potential risk for aquatic organisms for which no monitoring information is
available to date.” Cf. Opinion of the SCTEE of 28.09.1999. [12] This compares with 750 000 analyses from the EU15 for
water and sediment in the database compiled for the COMMPS procedure. [13] Commission Directive on technical specifications for
chemical analysis and monitoring of water status, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:201:0036:0038:EN:PDF
[14] See INERIS-IOW (2009), annex IX for exact definition [15] See INERIS-IOW (2009), annex XII [16] Salts and compounds of arsenic, cobalt and chromium are
grouped into three groups. [17] PCBs counted as 1 [18] Lepper (2005) http://circa.europa.eu/Public/irc/env/wfd/library?l=/framework_directive/thematic_documents/priority_substances/supporting_background/manual_methodology/_EN_1.0_&a=d
[19] Opinion of the Scientific
Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) on “The setting
of the Environmental Quality Standards for the Priority Substances included in
Annex X of Directive 20006/60/EC in accordance with Article 16 thereof”.
Adopted by CSTEE during the 43rd plenary meeting of 28 May 2004. (http://ec.europa.eu/health/archive/ph_risk/committees/sct/documents/out230_en.pdf
) [20] European Commission Technical Guidance Document in
support of Commission Directive 93/67/EEC on Risk Assessment for new notified
substances, Commission Regulation (EC) No 1488/94 on Risk Assessment for
existing substances and Directive 98/8/EC of the European Parliament and of the
Council concerning the placing of biocidal products on the market, Part I and
Part II. European Communities, 2003. [21] http://ec.europa.eu/environment/water/water-dangersub/pdf/wd_env_191000_01_final.pdf
[22] COM (2006) 397 and COM (2006) 398 Informal Background
Document Identification of Priority Hazardous Substances (including Annex) http://circa.europa.eu/Public/irc/env/wfd/library?l=/framework_directive/thematic_documents/priority_substances/supporting_background/identificationpdf/_EN_1.0_&a=d http://circa.europa.eu/Public/irc/env/wfd/library?l=/framework_directive/thematic_documents/priority_substances/supporting_background/identification_annexpdf/_EN_1.0_&a=d [23] http://ec.europa.eu/health/scientific_committees/environmental_risks/docs/scher_o_128.pdf