EUROPEAN COMMISSION 
Brussels, 31.1.2012  
SEC(2011) 1546 final 
 
COMMISSION STAFF WORKING PAPER 
EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT 
Accompanying the document 
Proposal for a 
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
amending Directives 2000/60/EC and 2008/105/EC as regards priority substances in the 
field of water policy 
  
{COM(2011) 876 final} 
{SEC(2011) 1547 final} 
 
 
EN 2   EN Disclaimer:  This executive summary commits only the Commission's services involved in its 
preparation and does not prejudge the final fo rm of any decision to be taken by the 
Commission. 
 
EN 3   EN 1. PROBLEM  DEFINITION  
1.1. Background 
The Water Framework Directiv e 2000/60/EC (WFD) establishe s a comprehensive framework 
for the protection of surface and groundwater, setting environmental objectives including the 
achievement of good chemical and ecological stat us and the prevention of  deterioration..  To 
meet good chemical status, water bodies must meet the Environmental Quality Standards 
(EQS) set for certain chemicals – the Priority Substances (PS) - identified under the WFD as 
posing a risk to or via the aquatic environment at  EU level. Some PS are identified as Priority 
Hazardous Substances (PHS) because of their pers istence, bioaccumulation and/or toxicity or 
equivalent level of concern. In addition to the objective of good chemical status, the WFD 
requires the adoption of control measures aimed at the progressive reduction of PS and at the 
cessation or phasing out of discharges, emissions and losses of PHS to the aquatic environment. Currently, control measures are ta ken at MS level; at EU level, measures are 
reliant on other legislation (s uch as REACH, plant protectio n products, biocides). The WFD 
also allows for exemption from meeting good chem ical status in specific water bodies on the 
grounds of technical unfeasib ility, disproportionate costs or natural conditions. 
 
The WFD (Article 16(4)) requires the Commission to review the list of PS at least every four 
years, and the EQS Directive 2008/105/EC (EQSD)  (Article 8) requires the Commission to 
report the outcome of its first review to the European Parliament and the Council in 2011.  As 
part of the review, the Commission has to consider inter alia the substances in Annex III of the Directive for possible inclusion in the list.  It is also required to identify, if appropriate, 
new PS or PHS, and to set EQS for surface water, sediment or biota as appropriate, and to 
review the existing PS. The propos ed new substances and change s to existing substances are 
expected to have an imp act in the 2015 updated RBMPs
1 and programmes of measures. 
The required  review was carried out with the assistance of the Working Group E on 
Chemical Aspects (WG E) under the WFD Common Implementation Strategy2, including 
participation of all MS and a wide range of stakeholders3. It was a scientific/technical exercise 
involving the identification of risks from chem icals to the aquatic e nvironment and the setting 
of EQS for them. The methodology for setting th e EQS, and the EQS derived, were submitted 
to the Scientific Committee on Health and Environmental Risks (SCHER4) for its opinion. 
The impact assessment takes as given the results of the scientific/technical work. 
In the course of reviewing the PS list, possibl e improvements in the functioning of the EQSD 
were identified, and a possible mechanism for improving the identification of additional PS in 
future reviews, and these are included as sepa rate sets of options. The preferred option is 
therefore a package of options. 
                                                 
1 River Basin Management Plans 
2 http://ec.europa.eu/environm ent/water/water-framework/o bjectives/pdf/strategy.pdf  
3 http://ec.europa.eu/transparency/reg expert/detailGroup.cfm?groupID=371 , under "Sub-groups", 
"Priority Substances". 
4 The SCHER is one of the Scientific Committees pr oviding the Commission with independent advice. It 
is made up of 17 scientists. More information at 
http://ec.europa.eu/health/scientific_committees/environmental_risks/index_en.htm    
 
EN 4   EN 1.2. What is the issue requiring action? 
Three main issues require action:  
(i) the availability of new information about risks caused by existing PS and new chemicals. 
New chemicals are being developed all the time, so not all will have been considered during the first prioritisation and for those that were, new information may have become available. 
(ii) the fact that some of th e most harmful chemicals already on the PS list or proposed for 
addition
5 are ubiquitous persistent, bioaccumulative and toxic (PBT) substances. The 
measures already taken on those have reduced emissions very significantly. However, because 
of their intrinsic properties, widespread use and common potential for long-range transport, 
some of them are still found in the aquatic envir onment, mostly in sediment and/or biota, at 
concentrations above the EQS, therefore entailin g widespread failures of the objective of good 
chemical status. Three sub-problems n eed to be considered, as follows: 
• Presentational issue: the widespread exceedances of the EQS by ubiquitous PBTs 
will hide the improvements made in relation to other substances because the 
chemical status of water bodies under the WF D has to be reported on the basis of all 
the PS.  
• Choice of monitoring matrix be tween water, sediment or biota: the EQSD currently 
allows MS to choose the matrix for each PS. PBTs tend to accumulate in sediment 
and/or biota and may be hardly detectable  in water even with state of the art 
analytical techniques. MS which appl y a water EQS might  inappropriately. 
categorise water bodies as having "good chem ical status" even when the sediment 
and/or biota contain PS at le vels that still pose a risk. 
• Reduced monitoring effort for ubiquitous PBTs: Any changes in the environmental 
concentrations of ubiquitous PBTs are likely  to occur only over the long term and a 
lower monitoring frequency and lower number of monitoring sites than normal under 
the WFD would seem justified.   
(iii) the fact that there is a paucity of f it-for-purpose monitoring data on which to base 
assessment of exposure and thus th e prioritisation of new PS in future reviews. A very large 
monitoring database was compile d for the current prioritisati on, but more could be done to 
overcome the vicious circle that  unless a substance is already regulated, it is unlikely to be 
widely monitored, but that if it is not monito red and the environmental concentrations cannot 
be reliably modelled either, estimation of the ri sk posed at EU level may not be robust enough 
to justify regulation. 
2. ANALYSIS OF SUBSIDIARITY  
Water pollution has a very important transboundary character. 60% of the EU territory lies in 
shared river basins (EC, 2007) . The Union’s policy for controlling the pollution of surface 
waters is set out in Article 16 of the WFD which, together with Article 8 of the EQSD, provides the basis for the PS list and its review. The related issues addressed in the options 
concern the functioning of the legislation. 
3. O
BJECTIVES  
 
                                                 
5 PBTs included in the PS list are by definition PHS. 
 
EN 5   EN The following table presents the general and specific objectives in relation to the problems, 
sub-problems and options:  
Problem Sub-problem General objective Specific objectives Options 
 
Existing 
substances Consider latest scientific knowledge  
Improve knowledge (of risks and 
effectiveness of measures taken to 
reduce or eliminate emissions) 
through monitoring  A2  
New information 
on risks to 
environment and 
human health 
 
Proposed 
substances  
Reduce the risks to or via the 
aquatic environment posed by 
certain substances 
Identify new substances that cause 
risks and set EQS for them 
Improve knowledge (as 
above)through monitoring  A3a-
A3c 
 Presentational 
issues Improve communication of progress 
in water quality within the WFD 
implementation B2a-
B2b 
 Choice of 
matrix Strengthen the curre nt legislation on 
the choice of the most suitable matrix 
for monitoring B3a-
B3b   
Specific difficulties 
with ubiquitous 
PBTs 
 
Monitoring 
effort  
 
Improve the functioning of the 
EQSD 
Reduce the administrative costs for 
MS by providing additional flexibility 
in monitoring ubiquitous PBTs while maintaining the effectiveness of the 
monitoring   B4a-
B4b 
Knowledge base - Provide adequate tools to 
improve the future 
identification of substances of 
concern to or via the aquatic 
environment at EU level. Provide a mechanism to improve the 
knowledge base and make future 
identification of PS more effective C2-C3 
 
4. POLICY OPTIONS  
4.1. Policy options in relation to the substances 
The first set of policy options refers to the in clusion of substances in Annex X of the WFD, 
the (re)determination of th eir status (PS or PHS) and the re vision or establishment of EU-wide 
EQS for them. The options are fully based on the outcome of the expert technical work. They 
are cumulative on the basis of theoretically increasing impacts, with pharmaceuticals being 
included last because they have not hither to been regulated under the WFD. Option A1 
represents no change to the current list. 
Option Substance Change or 
establishment 
of EQS in water?  Biota 
EQS 
proposed? 
 Change from 
PS or 
identified as PHS? 
Anthracene Y N N 
Poly-BDE Y* Y  N 
DEHP N N Y 
Lead Y N N 
Naphthalene   Y N N 
Nickel Y* N N 
Polyaromatric hyrocarbons 
(PAHs)    
   Benzo(a)pyrene Y* 
   Benzo(b)fluoranthene Y* 
   Benzo(k)fluoranthene Y* Option A2: Change EQS 
and/or status of existing PS 
   Indeno(1,2,3-cd)pyrene Y* Y  N 
 
EN 6   EN Option Substance Change or 
establishment 
of EQS in water?  Biota 
EQS 
proposed? 
 Change from 
PS or 
identified as PHS? 
   Benzo(g,h,i)perylene Y* N 
Fluoranthene Y* Y  N 
Trifluralin N N Y 
Dicofol Y Y Y 
PFOS Y Y Y 
Quinoxyfen Y N Y Option A3a: Existing-PS 
changes plus (selected) Annex 
III substances 
Dioxins and DL-PCBs N Y Y 
Aclonifen Y N N 
Bifenox Y N N 
Cybutryne Y N N 
Cypermethrin Y N N 
Dichlorvos Y N N 
HBCDD Y Y Y 
Heptachlor/ heptachlor 
epoxide Y Y Y Option A3b: Existing-PS 
changes plus (selected) Annex 
III substances plus other new substances excluding 
pharmaceuticals 
Terbutryn Y N N 
17 alpha-ethinylestradiol 
(EE2) Y N N 
17 beta-estradiol  (E2) Y N N Option A3c: Existing-PS 
changes plus (selected) Annex 
III substances plus other new 
substances including pharmaceuticals Diclofenac Y N N 
For existing PS, Y* implies a change in EQS gr eater than one order of  magnitude. Other EQS 
changes for existing PS (marked only Y) are minor. 
4.2. Policy options in relation to ubiquitous PBTs and the knowledge base 
The three sub-problems associated with ubiqui tous PBTs are addressed by sub-options B2a 
and b, B3a and b, B4a and b.  These sub-optio ns, the substance options A2-A3c, and the 
knowledge-base options C2-C3, ar e independent. Options B3a and B3b could apply to any 
PS, not only ubiquitous PBTs. 
 
Option Description 
B1: No change  No change to current functioning of EQSD and WFD 
B2a: Allow separate 
presentation of 
ubiquitous PBTs Allow MS to present the ubiquitous PBTs sepa rately from the rest of the PS/PHS in 
their RBMP assessments, whilst still including them in the chemical and overall 
assessment. 
B2b: Take ubiquitous 
PBTs out of chemical 
status Take ubiquitous PBTs out of chemical status altogether, whilst maintaining the 
obligation to monitor and report trends. Good status could be met on the basis of 
satisfying the EQS for the other PS. 
B3a: Choice of matrix 
linked to analytical sensitivity MS would be able to choose the matrix  except where the available analytical 
technique fulfils the performance criteria
6 in one matrix and not in the other(s), or no 
analytical technique meets the performance criteria but the technique for one matrix 
performs significantly better than the others , and there is an EQS available at EU 
level for at least the ‘best performing’ matrix. 
B3b: Fixedmatrix The choice of matrix for monitoring and co mpliance checking would be fixed at EU 
level for each substance. 
                                                 
6 Commission Directive 2009/90/EC requires MS to use analytical techniques th at meet certain minimum 
quality requirements in relation to the EQS. In th e absence of techniques that meet such minimum 
criteria, the best available techniques no t entailing excessive costs should be used. 
 
EN 7   EN Option Description 
B4a: Conditional 
decrease inmonitoring 
for ubiquitous PBTs Reduce monitoring obligations for ubiquitous PBTs if certain specified conditions are 
met: enough information on the presence of the substance in water bodies (in 
particular in sediment and/or biota), i.e. a robust monitoring baseline. 
B4b: Unconditonal decrease in monitoring 
for ubiquitous PBTs Reduced monitoring requirements for ubiquitous PBTs would be specified in the 
EQSD without conditions. 
C2: Knowledge base: watch list without legal obligation Establish a voluntary mechanism for monitoring substances posing a possible risk to 
or via the aquatic environment at EU level using a "dynamic" list (with substances being regularly added and removed) to ensure the provision of high-quality EU-wide 
monitoring data for the prioritisation process. Around 20 substances to be on the list 
at any one time, monitored by MS at 250-300 representative sites across the EU according to agreed technical guidelines.  
C3: Knowledge base:  
watch list with legal 
obligation Establish a mechanism as in C2 but with  a legal obligation for MS to monitor. 
5. ASSESSMENT OF IMPACTS  
5.1. Impacts of options related to the substances 
Option Positive impacts Negative impacts 
A2 Better and more robust knowledge of the 
extent of the risks, coherence with the 
latest scientific progress, allowing MS 
and other policies to take the necessary measures to reduce the risks caused by 
these substances. 
Improved protection of human health and aquatic biodiversity. Potential significant costs to upgrade some 
industrial and UWWTPs (for Nickel) to 
meet AA-EQS of 2 μg/l, depending on 
local conditions. (UK estimate of approximately €2 billion whole-life 
investment plus attendant additional 
running costs.). Lower costs if AA-EQS set to 4 μg/l. 
 
A3a As above plus: Additional information 
about the risk posed by the additional 
substances and about the effectiveness of 
related measures.  Valuable data and information for 
decision making in the context of the 
plant protection product, chemicals, industrial emissions and waste policy. 
Additional protection of human health 
and aquatic biodiversity. Depending on local conditions, potential 
significant costs to upgrade some industrial 
and UWWTPs (for Nickel). 
Additional monitoring costs of 4-9.6 million € per year for the whole EU. 
Substitution costs for Quinoxyfen, if not in 
baseline. 
A3b As above plus: Valuable data and 
information for decision making in the 
context of the biocides policy 
Additional protection of human health and aquatic biodiversity. Additional cumulative monitoring costs 
(over and above Option A2) of 12-28.8 
million € per year for the whole EU. 
In addition to non-monitoring costs of option A3a: potential costs of substitution 
(if necessary for Cybutryne and Terbutryn, 
possibly Cypermethrin in salmon farming). 
A3c As above plus: Improved information on 
the extent of pollution by 
pharmaceuticlas, and  EU-wide EQS as 
benchmarks for deciding possible measures at MS level.  
Additional protection of human health 
and aquatic biodiversity. Additional cumulative monitoring costs 
(over and above Option A2) of 15-36 
million € per year for the whole EU.  
In addition to non-monitoring costs of option A3b:  
P
ossible costs of additional UWWTP 
upgrades to remove E2 if locally required 
and not sufficient from option A2 and to 
reduce E2 emissions from livestock to water. 
 
EN 8   EN Monitoring costs are likely overestimated for the options that include more substances as, for 
example, sampling costs increase less steeply  as the number of substances increases. 
5.2. Impacts of options related to ubi quitous PBTs and knowledge base 
Option Positive impacts Negative impacts 
B2a Easier demonstration by MS of reduced 
pollution by other PS despite failures for 
ubiquitous PBTs. Legal certainty maintained by no change in definition of chemical status. No significant negative impacts identified though 
there could be discrepancies between the 
approaches taken by different MS.  
B2b Very straightforward way of allowing MS to 
demonstrate progress in reducing pollution by 
other PS.  Reduced environmental protection because there 
would be no EU EQS and no driver for taking 
measures. Legal uncertainty. 
B3a   Improved harmonisation of the assessment of 
chemical status; better picture of the extent of 
the problem. Flexibility to quickly adapt 
monitoring strategies to new analytical techniques.  Possible limited adaptation costs for some MS 
without experience in monitoring and analysis in 
certain matrices. Lack of legal clarity if there are 
no standardised analyti cal methods for certain 
substances. 
B3b  
 High level of harmonisation of the assessment 
of chemical status and a good picture of the 
extent of the problem. Legal clarity. Possible adaptation costs for some MS without 
experience in monitoring and analysis in certain 
matrices. Impossible to adapt quickly to new 
analytical techniques. 
B4a Cost savings of 0.8 to 2.9 million € per annum 
in EU.  No significant negative impacts identified. 
B4b Cost savings of 0.8 to 2.9 million € per annum 
in EU.  Certain undesirable trends or hotspots could be 
overlooked. 
C2 Objective of fit-for-purpose EU-wide 
monitoring data to support prioritisation likely 
to be met at least partially. Monitoring costs: 2 to 4 million € per year for the 
EU. Costs to develop technical specifications for 
monitoring (less than 0.2 million € per year for the whole EU).  
C3 Legal obligation would make the outcome more 
certain to meet the objective (without it, MS 
would prioritise (other) legal obligations in their budgets). As above for option  C2, plus minor additional 
administrative costs in th e European Commission.. 
 
6. COMPARISON OF OPTIONS  
6.1. Comparison of the options related to the substances 
As regards effectiveness at achieving the objec tives, the broadest optio n (A3c) takes greatest 
account of the latest scientific information included in the review,significantly improves 
knowledge of the risks posed by all the newly id entified substances, , and optimises protection 
against them. No additional measures are proposed at EU level.  Any necessary measures would most likely be taken at local level, alt hough actions at EU level under other legislation 
could in due course be prompted if the mon itoring information made this necessary.  The 
baseline takes account of ex isting measures and expected  decisions under other EU 
legislation. No disproportionate costs at EU  level are identifie d. If disproportioante costs were incurred 
locally, the exemptions under the WFD could be  used for particular  water bodie s if the 
conditions set out in the WFD are fulfilled. 
6.2. Comparison of the options related to  ubiquitous PBTs and knowledge base 
Option Effectiveness Efficiency  Consistency Overall 
mark 
B1 0 0 0 0 
Options on presentation 
 
EN 9   EN B2a ++ 
Avoids presentational issue although 
formally chemical status would still 
be affected by the ubiquitous PBTs. ++ 
No major costs involved and 
reduced administrative burden for 
MS. + 
Coherent with WFD, 
providing more 
flexibility in terms of 
presentation  +++++ 
B2b + 
Avoids presentational issue 
completely but undermines the 
objective of reducing the risks posed 
by certain substances. ++ 
No major costs involved and 
reduced administrative burden for 
MS. -- 
Incoherent with WFD 
and chemicals policy. + 
Options on monitoring matrix 
B3a ++ 
Strong driver for using the most 
appropriate matrix. Contributes to 
improved knowledge of the risks of 
substances and effectiveness of 
measures. Possible to take into 
account local situation. Possible lack 
of legal certainty if no international 
analytical standards. + 
Retention of some flexibility 
would allow MS to adapt to local 
circumstances and 
tradition/experien ce.  Moderate 
adaptation costs for some MS. + 
Reinforces the role of 
Directive 2009/90/EC. 
Contributes to 
improved assessment of 
effectiveness of 
measures taken by 
other policies. ++++ 
B3b ++ 
Strong driver for using the most 
appropriate matrix. Contributes to 
improved knowledge of the risks of 
substances and effectiveness of 
measures. Not possible to take into 
account local situations. Legal 
certainty. - 
Higher adaptation costs for MS 
that have no tradition/experience 
to monitor in biota. ≈ 
Less flexible to adapt to 
progress in analytical 
techniques. Could 
hinder progress in 
analytical techniques 
for other matrices. + 
Options on reduced monitoring 
B4a + 
Reduces administrative burden and 
monitoring costs for MS.  + 
Ensures that a robust monitoring 
baseline is available, hence 
contributing to good knowledge of 
the risks to or via the aquatic 
environment of ubiquitous PBTs. ≈ ++ 
B4b + 
Reduces administrative burden and 
monitoring costs for MS.  ≈ 
Does not guarantee a robust 
monitoring baseline in all MS, 
therefore not ensuring a good 
knowledge of the risks to or via 
the aquatic environment of 
ubiquitous PBTs. ≈ + 
C2 + 
Increased knowledge but likely to 
suffer important data gaps 
(incomplete coverage  of MS) and lack 
of adherence to technical 
specifications due to the voluntary 
character. + 
Value for money decreased by the 
likelihood of data gaps. NA ++ 
 
C3 ++ 
Increased knowledge and likely to 
cover all or most of the EU countries 
in a harmonised way  ++ 
Provides targeted high-quality EU 
datasets, fit for purpose for PS 
prioritisation. NA ++++ 
 
Magnitude of impact as compared w ith the baseline scenario (the baseline is indicated as 0): ++ strongly 
positive; + positive; – – strongly negative; – negative; ≈ marginal/neutral; NA not applicable 
 
6.3. Summary of preferred options and impacts 
The preferred options are: 
A3c - all substances; B2a - flexible presentation for ubiquitous PBTs; B3a - choice of matrix linke d to analytical sensitivity; 
 
EN 10   EN B4a - conditional reduced monitoring for ubiquitous PBTs; 
C3 - watch list with legal obligation.  These would be implemented by amending th e EQSD 2008/105/EC and WFD Annex X. The 
benefits, costs and distributi onal effects relative to the baseline are summarised in the 
following table, taking account of th e interactions between the options. 
 
Benefits 
• All the latest scientific information reviewed would be taken into account; 
• MS would be encouraged to monitor in biota when most appropriate; 
• A more accurate picture would be obt ained of pollution by ubiquitous PBTs; 
• There would be a significant improvement in knowledge of the risks posed by all 15 of the prioritised substances 
and the ubiquitous PBTs among the existing PS, and of the effectiveness of measures for these substances, 
allowing introduction/improvement of m easures at EU and MS le vel, better targeting of sediment remediation, 
and optimisation of prot ection from identified risks - thus leading to benefits to biodiversity and human health; 
• Measures applied to reduce the risks from some substances (e.g. Nickel) would be seen to reduce the risks from 
others (e.g. E2) as well; 
• The harmonisation of EQS for more s ubstances would provide a more leve l playing field for businesses in 
different MS; 
• The administrative burden associated with explaining the failure of the chemical status objective as a result of 
ubiquitous PBTs would be reduced, and the publ ic would receive clearer information; and 
• Savings on monitoring ubiquitous PBTs would be e xpected, which could be invested in improving the 
information base for future prioritisation exercises, i.e. the watch list; 
Costs 
• Additional monitoring costs to public authorities; 
• Costs to public authorities and private companies, likel y passed to consumers, of additional UWWT to remove 
Nickel and E2, costs to industry to reduce point source industrial emissions  of Nickel, and costs to livestock 
farmers to install fencing to keep animals away from water courses to reduce E2 emissions to water, although 
some of those costs could fall  under other legislation;  
• The possible costs, unknown but not likely to be significa nt, of substituting Quinoxyfen, if authorisation not 
anyway withdrawn under the plant protection products legisl ation; these could fall on the producers, formulators, 
farmers and/or consumers depending upon the substitute; 
• Costs to operate the watch-list. 
Main distributional effects 
The most significant distributional effects are summarised here, ex cept generic environmental and he alth benefits. Most relate 
to the preferred substance option (A3c) ra ther than the options addressing the othe r general objectives. There is uncertainty 
about how many would be in the baseline. 
Sectoral effects 
• could occur in agriculture and plant protection products, due to the inclus ion of four currently used plant 
protection products in the preferred package;  however, mo st of the measures that might be needed would be 
expected in the baseline; 
• could also occur in the water industry, resulting from the need to meet a more stringent EQS for Nickel, and an 
 
EN 11   EN EQS for E2; 
• would occur in the public sector as a result of having to  monitor additional substances, and possibly also to cover 
investiments in UWWTPs (a cost that w ould likely be passed on to consumers); 
• could occur in other sectors such as aquaculture, constr uction the metals industry, transport and waste handling, 
but would not be expect ed to be significant. 
Producer and user-specific effects 
• could arise for the producers and formulators of the pest idices and biocides, again depending upon the baseline; 
• could affect the export of certain substances still produced in the EU for export, including HBCDD and 
Trifluralin, although this export could stop anyway under the baseline. 
MS and region-specific effects 
• could include minor effects on trade in relation to expor ted and imported substances, but these would be largely 
in the baseline; 
• could occur in relation to plant protection products, si nce some MS use more and have a larger number of 
products on the market; 
• could include effects relating to relative pharmaceutical c onsumption, extent of coastline, prevalence and density 
of urban conurbations, intensity of livestock farmi ng, and natural conditions affecting bioavailability 
Overall, the preferred options w ould achieve the most objectives with the greatest efficiency 
while ensuring coherence with the existing legislation and avoidi ng significant unfair 
distributional effects. 
7. MONITORING AND EVALUATION  
The WFD contains built-in monitoring and evalua tion processes.  Regular monitoring of the 
environmental concentrations of the PS a nd PHS is foreseen in the Directive.