EUROPEAN COMMISSION 
Brussels, 31.1.2012  
SEC(2011) 1547 final 
 
COMMISSION STAFF WORKING PAPER 
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) 1546 final} 
 
 
EN 1   EN Disclaimer:  This impact assessment 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 2   EN TABLE OF CONTENTS 
1. Procedural issues and consulta tion of interested parties.............................................. 6 
1.1. Overview.................................................................................................................. .... 6 
1.2. Impact Assessment Steering Group (IASG) ................................................................ 6 1.3. Expertise for the technical process............................................................................... 6 1.4. Stakeholder consultation .............................................................................................. 7 1.4.1. Stakeholders and nature of consultation ...................................................................... 7 1.4.2. Consultation outputs .................................................................................................... 8 
1.5. The Impact Assessment Board..................................................................................... 8 2. Problem definition........................................................................................................ 9 2.1. Introduction: policy context/background ..................................................................... 9 2.2. What is the issue or problem requiring action?.......................................................... 11 2.2.1. General points .......................................................................................................... .. 11 
2.2.2. Summary of main issues/problems ............................................................................ 11 2.2.3. New information on risks to environment and human health.................................... 12 2.2.4. Specific difficulties with ubiquitous pers istent, bioaccumulative and toxic (PBT) 
chemicals.................................................................................................................... 15  
2.2.5. Knowledge base ......................................................................................................... 1 6 
2.3. What are the underlying dr ivers of the problem?....................................................... 18 
2.4. Who is affected by the problems identified, in what ways and to what extent?........ 19 
2.5. How would the problem evolve , all things being equal?........................................... 19 
2.5.1. New information on risks to environment and human health.................................... 19 2.5.2. Specific difficulties with ubiquitous persis tent, bioaccumulative and toxic chemicals23 
2.5.3. Knowledge base ......................................................................................................... 2 3 
2.6. Does the EU have the right to act?............................................................................. 24 3. Objectives.................................................................................................................. . 24 
4. Policy options............................................................................................................. 2 5 
4.1. Overview.................................................................................................................. .. 25 
4.2. Policy options in relation to the substances ............................................................... 25 4.2.1. Introduction............................................................................................................ .... 25 
 
EN 3   EN 4.2.2. The options A1, A2 and A3 (a)-(c) ............................................................................ 26 
4.3. Policy options in relation to the spec ific difficulties with ubiquitous PBTs.............. 27 
4.3.1. Option B1: No change................................................................................................ 28 4.3.2. Option B2a presentation: Allow separa te presentation of ubiquitous PBTs.............. 28 
4.3.3. Option B2b presentation: Take ubiquit ous PBTs out of chemical status .................. 28 
4.3.4. Option B3a choice of matrix: Leave flexibil ity but link the choice to requirements of 
Directive 2009/90/EC ................................................................................................ 28 
4.3.5. Option B3b choice of matrix: Fix the pr eferred matrix for each substance............... 29 
4.3.6. Option B4a monitoring: In troduce reduced monitoring obl igations for ubiquitous 
PBTs if certain specified conditions are met.............................................................. 29 
4.3.7. Option B4b monitoring: In troduce reduced monitoring obl igations for ubiquitous 
PBTs (unconditional) ................................................................................................. 29 
4.4. Policy options in relation to improving the knowledge base ..................................... 29 4.4.1. Option C1: No change................................................................................................ 29 4.4.2. Options C2 and C3: Establishment of a watch list..................................................... 29 4.4.3. Option C2: Establish a watch li st without legal obligation........................................ 30 
4.4.4. Option C3: Establish a watch li st with legal obligation............................................. 30 
5. Analysis of impacts and comparison of the options................................................... 30 
5.1. Introduction.............................................................................................................. .. 30 
5.2. Analysis of impacts of the substance options ............................................................ 31 5.2.1. General considerations as regards costs and benefits of the substance options......... 31 
5.2.2. Uncertainties in the analysis  of the substance options............................................... 35 
5.2.3. Analysis of impacts of Option A2: Change  EQS and/or status of existing PS.......... 36 
5.2.4. Analysis of impacts of Option A3a: Existing-PS changes plus Annex III substances41 5.2.5. Analysis of impacts of Option A3b: Exis ting-PS changes plus Annex III substances 
plus other new substances excluding pharmaceuticals .............................................. 43 
5.2.6. Analysis of impacts of Option A3c: Existing-PS changes plus Annex III substances 
plus other new substances including pharmaceuticals............................................... 46 
5.3. Comparison of the substance options......................................................................... 50 5.4. Analysis of impacts of options in  relation to the ubiquitous PBTs............................ 52 
5.4.1. Analysis of impacts of Option B2a on presentation: Give more flexibility on 
presentation ................................................................................................................ 52 
 
EN 4   EN 5.4.2. Analysis of impacts of Option B2b on pr esentation: Take ubiquitous PBTs out of 
chemical status ........................................................................................................... 52 
5.4.3. Analysis of impacts of Option B3a on choi ce of matrix: Leave fl exibility but link the 
choice to requirements of  Directive 2009/90/EC....................................................... 53 
5.4.4. Analysis of impacts of Option B3b on choi ce of matrix: Fix the preferred matrix for 
each substance............................................................................................................ 53 
5.4.5. Analysis of impacts of Option B4a on monitoring: Introduce reduced monitoring 
obligations for ubiquitous PBTs if cer tain specified conditions are met ................... 54 
5.4.6. Analysis of impacts of Option B4b on monitoring: Introduce reduced monitoring 
obligations for ubiquitous PBTs (unconditional)....................................................... 54 
5.5. Comparison of options in rela tion to the ubiquitous PBTs........................................ 55 
5.6. Analysis of impacts of options to improve the knowledge base................................ 56 
5.6.1. Analysis of impacts of Option C2: Establis h a watch list without legal obligation... 56 
5.6.2. Analysis of impacts of Option C3: Establ ish a watch list with legal obligation........ 56 
5.7. Comparison of the options to improve the knowledge base ...................................... 57 5.8. Cumulative impacts, interactions acro ss the various options and significant 
distributional effects................................................................................................... 57 
5.8.1. Interactions and cumulative impacts.......................................................................... 57 
5.8.2. Cumulative impacts of the p ackage of preferred options........................................... 59 
5.8.3. Distributional effects of the package of preferred options......................................... 60 
5.8.4. Approach to translating the opti ons into a legislative proposal ................................. 63 
6. Monitoring and evaluation ......................................................................................... 63 
ANNEXES 
ANNEX I: Glossary / List of acronyms 
ANNEX II: Summary of the prioritisation process and the establishment of EQS 
ANNEX III: Background and details regarding ubi quitous PBTs and knowledge base (watch 
list) options 
ANNEX IV: Approach to the assessment of impacts ANNEX V: Substance factsheets ANNEX VI: Description of the main policies affec ting the baseline and interactions with the 
WFD 
ANNEX VII: List of stakeholders involved in the consultation  
 
EN 5   EN ANNEX VIII: References 
 
 
EN 6   EN 1. PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES  
1.1. Overview 
The Commission proposal which this Impact A ssessment concerns addresses the control of 
pollution of surface water bodies by Priority Substances (PS) - chemicals presenting a 
significant risk to or via the aquatic environment at EU level - . The Water Framework Directive (WFD) 2000/60/EC
1 (Article 16(4)) requires that the list of PS be reviewed at least 
every four years. Technical work on the review began in 2007.  It aimed to identify 
substances that should be added to the lis t through a prioritisation exercise, to set 
environmental quality standards (EQS)2 for them, and to review th e EQS for and status of the 
existing PS.  As the technical work was in its final stages in 2010, work on the impact assessment began with the commencement of a study by the consultancy Entec
3.  The 
consultant drafted individual substance impacts reports taking into account the conclusions of 
the technical work4, and these were drawn upon  for a large part of this Impact Assessment 
Report. 
In the course of reviewing the PS list, possi ble improvements in the functioning of the 
Environmental Quality Standard s Directive (EQSD) 2008/105/EC5 were identified, and a 
possible mechanism for improving the identification of additional PS in future reviews, and 
these are included as separate se ts of options. The preferred op tion is therefore a package of 
options. 
The roadmap for the assessment was drafted in March and finalised in October 2010. 
1.2. Impact Assessment Steering Group (IASG) 
Meetings of the IASG were he ld in February 2010, March, April and May 2011, with a fifth 
and final meeting on 18 May 2011.  The following DGs  attended one or more of the meetings: 
the Secretariat General (SG), AGRI, ENTR, JRC, MARE, REGIO, RTD, and SANCO. DG 
ENTR and DG SANCO also attended meetings  of the working group s doing the technical 
work and contributing to the impact  assessment study (see section 1.3). 
1.3. Expertise for the technical process 
The technical work for the review, i.e. princi pally the prioritisation and EQS setting, was led 
by DG ENV and the JRC and carrie d out by a range of experts.   These included members of 
                                                 
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  An EQS is defined as the concentration of a particular pollutant or group of pollutants in water, 
sediment or biota which should not be exceeded in order to protect human health and the environment’ 
(WFD Article 2.35) 
3     Study Contract No 070307/2009/547548/SER/D1 
4  For the existing substances under review, some of the supporting information for the study was 
prepared by a second consultancy, WRc (with input from Milieu). 
5  Directive 2008/105/EC of the European Parliame nt and of the Council of 16 December 2008 on 
environmental quality standards in the field of water Policy [OJ L 348, 24.12.2008, p. 84] http://eur-
lex.europa.eu/LexUriServ/LexUriSer v.do?uri=CELEX:32008L0105:EN:NOT 
 
EN 7   EN the Chemical Aspects Working Group E unde r the WFD Common Implementation Strategy 
(CIS)6, in particular two sub-groups of WG E, a nd the consultancy INERIS (with input from 
the Institute of Water, IoW).  The membership  of WG E and the two sub-groups consists of 
Commission DGs, Member States (MS) and stakeholder organisa tions including a range of 
European industry associations (AESGP , AISE, Business Europe, CEFIC, CEPI, 
CONCAWE, COPA-COGECA, ECPA, E FPIA, EUCETSA, EUDA, EUREAU, 
EURELECTRIC, EUROFER, EUROMETA UX, EUROMINES) and NGOs (EEB, 
Greenpeace, OSPAR , WWF).  Annex VII gives the full names and sectors. 
WG E contributed significantly to the review by supporting the collection of da ta (including 
monitoring and hazard data), the prioritisation process for identifying new substances, the 
update of the Technical Guidance Document on EQS setting, and the derivation of EQS.  The 
two sub-groups of WG E that carried out much of the work were the Expert Group on the 
Technical Guidance Document EQS (EG-EQS), and the Sub-Group on Review of Priority 
Substances (SG-R), both chaired by the J RC.  The WG E industry stakeholder groups 
involved their most relevant member companies,  generally represented by technical experts, 
in the sub-group discussions, particularly as th e selection procedure re ached its final stages 
and EQS were developed. 
The draft EQS were submitted to the Scientific Committee on Health and Environmental 
Risks (SCHER)7 for its opinion.  
1.4. Stakeholder consultation 
1.4.1.  Stakeholders and nature of consultation 
The members of WG E – i.e. all MS and the mo st relevant stakeholde r organisations - were 
kept informed of the progress on the technical work  in the sub-groups throughout the review 
process. They contributed information to th at process and provided information to the 
consultancy Entec for the impact assessmen t study.  They were consulted twice on the 
methodology and twice on the draf t substance impacts reports. 
The penultimate drafts of the substance impacts reports were also sent to additional selected 
stakeholders in a targeted stakeholder consulta tion, to cover organisations (see Annex VII) not 
already (fully) represented on WG  E.  In view of the wide range of organisations/sectors 
already involved in WG E, th eir involvement throughout the pro cess, and the technical nature 
of the review, it was judged approp riate to target additional cons ultation to selected additional 
organisations rather than to conduct a full  public consultation. Othe r DGs were asked to 
propose organisations whose interests might require additional representation, and those 
targeted included groups repres enting the fishing/a quaculture and trans portation industries, 
medical professionals and users/ consumers. Output from a pub lic internet consultation would 
likely have been of a very general nature, and un likely to add to the feedback already gathered 
by other means. For example, in the Flash Eurobarometer on water in 2009, 75% of EU citizens identified chemical pollution of water as a threat to the water environment, a higher 
                                                
 
6  http://ec.europa.eu/environm ent/water/water-framework/o bjectives/pdf/strategy.pdf   
7  The SCHER is one of the Scientific Committees providing 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 8   EN proportion than for any other threat. In  the 2011 Environment Eurobarometer8 water pollution 
was most frequently identified as one of  the top five environmental concerns. 
1.4.2.  Consultation outputs 
The involvement of WG E and its sub-groups in the technical  process from its inception 
allowed the represented MS and organisations to  inform the selection of new PS and the EQS 
setting, for example by highlightin g substances of concern or re levant toxicity studies. The 
general view of MS and stakeholde rs in WG E is that the results of the technical work have a 
sound scientific basis despite some differences  of opinion between industry and MS experts – 
as for example highlighted to the SCHER for its consideration. 
The development of the options was inform ed by discussion on issues including the 
appropriateness of setting sediment and biota st andards, and the difficulty for MS of dealing 
with "ubiquitous PBTs".  Some stakeholder views on specific options are mentioned in the 
relevant sections.  The need to interface effec tively with other legislat ion (see Annex VI) was 
emphasised. 
1.5. The Impact Assessment Board  
This Impact Assessment Report was discussed by the Impact Assessment Board on 22 June 
2011, leading to a positive opinion with commen ts. The Board commented in its overall 
assessment that the findings of the IA should be presented more clearly.   For this reason, the 
material in the report has been  substantially reorganised and supplemented, to some extent 
using information from the existing annexes.  The overview (section 1.1) makes clearer what 
the options cover; the policy context (section 2. 1) elaborates on the current assessment of the 
River Basin Management Plans; the baseline has been more cl early presented (see point 2 
below); the introductory parts of section 5.2 explain in more de tail the analysis of costs and 
benefits of the substa nce options and the uncer tainties involved; and specific reference is 
made to SMEs. Finally, the preferred policy pack age is compared to the baseline in section 
5.8.2. 
The Board provided five main groups of reco mmendations.  These have been acted upon as 
follows: 
(1) Better present the scale of the problem and the experience with implementation of the 
relevant provisions of the WFD  
Risks to health and the environment from the ca ndidate substances, and current levels of use 
and production, have been summarised in a new table in section 2.2.3.  This section also 
explains the prioritisation process in more detail.   The participation of interested businesses is 
elaborated in section 1.3, and additional re ferences to stakeholder views on individual 
substances have been made in section 5. Information on substitutes has been included in the (adapted) tables in section 5.2.  Preliminary information on the use by MS of provisions for exemptions in the WFD is presented in section 2.1. 
(2) Provide a more coherent baseline scenario and clearly explain the role of other existing 
policy instruments  
                                                 
8  http://ec.europa.eu/environment/working_en.htm   
 
EN 9   EN The section on the baseline (2.5.1) has been expa nded to explain better how other legislation 
including REACH and the Biocidal Products Directive could affect the baseline, and 
influences on the baseline in the substance optio ns are summarised in the tables in section 5.2. 
Other references to the relationship between the WFD and REACH are made in sections 2.1 
and 4.2.1.  The numbers of MS that have set na tional standards for the candidate PS are now 
given in the table in section 2.2.3 (the details can still be foun d in Annex VI) and comment is 
made on the likelihood that other MS woul d follow. The information on exemptions in 
section 2.1 distinguishes between applications on the ba sis of disproportiona te costs and those 
on other grounds. 
(3) Present expected costs and benefits in a more systematic and transparent way  
The report attempts to be more explicit about the cost estimates (separately for business and 
public authorities), the uncertainties around them  and the process for collecting and validating 
them (sections 5.2.1, 5.2.2 and the adapted tables a nd text on the individual substance options 
in section 5.2). The issue of di sproportionate costs,  including the releva nce of socio-economic 
assessment under other legislation, is addressed in sections 5.2.1.2 and 5.3. The benefits of the 
proposal have been brought out more clearly by stressing the contri bution made by the WFD 
to providing monitoring data in sections 2.5.1 and 5.2, by summarising th e risks posed by the 
candidate substances in sect ion 2.2.3, and by clarifying what is already included in the 
baseline (particularly in the tables in section 5.2). 
(4) Assess impacts on SMEs  
The implications of the substance options fo r SMEs are indicated in section 5.2.1.2 and the 
sections in 5.2 analysing the individual substa nce options (especially the adapted tables). The 
compliance strategies of MS ar e mentioned in section 5.3, and reference to the likelihood of 
MS exempting SMEs on grounds of dispropor tionate costs is made in section 5.2.1.2. 
(5) Include a clear overview of costs and benefits of the reta ined policy package  
The report explains better in section 4.2.1 how measures could be triggered by the proposal, 
and stresses in sections 2.5.1 and 5.2 the value of the monitoring data  delivered under the 
WFD. Comparison of the options with the ba seline has been made more consistent. The 
benefits and costs of the pref erred package of options are summarised in section 5.8.2, and the 
section on distributional impacts elaborates on several points, in cluding the possible impact of 
high production and use coinci ding in particular MS. 
Additional technical comments by the Board ha ve been addressed throughout the report. 
The Board's request that the absence of a public  internet consultation be better explained has 
been addressed in section 1.4.1.  The views of stakeholders have been more extensively 
incorporated in the report.  The Executive Su mmary has been complemented with a summary 
of the costs and benefits of th e preferred package of options. 
2. PROBLEM DEFINITION  
2.1. Introduction: policy context/background 
The WFD acknowledges the existen ce of considerable pressures on the aquatic environment, 
including that from chemical pollution, and the need for sustainable water management.  Its  
 
EN 10   EN environmental objectives include  the achievement of good chemi cal and ecological status for 
surface and groundwater bodies, and the preventi on of deterioration.  The Directive is 
implemented at the level of ri ver basin districts ( RBDs).  MS were requ ired to adopt by 2009 
a River Basin Management Plan (RBMP) based inter alia on a pressures and impact analysis 
and the results of monitoring, and a progr amme of measures for each district.  
To meet good chemical status, water bodies must meet the EQS set for the PS. The current 33 
PS include a range of industrial chemicals, pe sticides and metals/metal compounds. Some PS 
are identified as Priority Hazardous Substa nces (PHS) because of their persistence, 
bioaccumulation and/or toxicity or equivalent le vel of concern, criteria consistent with the 
criteria for Substances of Very High Concern (SVHCs) unde r REACH. MS are required to 
monitor the PS in surface wate r bodies, and to report exceedance s of the EQS.  The objective 
of good ecological status requires that for chemi cals identified as substances of concern at 
local/river-basin/national level but not as PS at EU level, standards have to be set at national level. These chemicals are know n as River Basin Specific Pollutants (RBSPs). The WFD 
requires the adoption of measures to control the discharges, emissions and losses of PS and 
PHS to the aquatic environment – progressive  reduction in the case of PS, cessation or 
phasing out in the case of PHS. 
The WFD (Article 16(4)) requires the Commission to  review the list of PS  at least every four 
years, and the EQSD (Article 8) requires the Commission to report the outcome of its first 
review to the European Parlia ment 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 appr opriate, new PS or PHS, and to set EQS for surface 
water, sediment or biota
9 as appropriate, and to review the existing PS.  The proposed new 
substances and changes to exis ting substances are expected to be taken into account in the 
2015 updated RBMPs and programmes of measures. 
Member States' first RBMPs, and their progre ss on complying with the EQS for the existing 
PS, are currently being assessed.  However, beca use the end of the first RBMP cycle (i.e. in 
2015) has not yet been reached, and the EQSD did not come properly into play until mid 
2010, it would be premature to conclude on the success of the MS in meeting the chemical 
status objective in 2015.  However, the prel iminary assessment shows that significant 
percentages of water bodies are currently failin g to achieve the objective of good chemical 
status (e.g. 28% of surface water bodies in BE, 29% in CZ, 16% in FR, 24% in NL).   
Indeed, the analysis of the RBMPs done so far shows that many MS will use the provisions to 
apply exemptions from meeting the 2015 ch emical status objective on socio-economic 
grounds, either to allow extension of the deadline s (WFD Article 4(4)) or, less frequently, to 
lower the environmental objectives (WFD Article  4(5)). In the first RBMPs, at least 15 MS 
are applying exemptions, and between them they  are using all the main grounds, i.e. technical 
unfeasibility, disproportionate costs, or natura l conditions not allowing timely improvement – 
in that order, i.e. technical unfeasibility is cite d more than twice as often as disproportionate 
costs, which is cited in turn more than twice as frequently as natura l conditions. It can be 
concluded that in many MS there will be a delay in reaching the EQS for some substances, meaning that those substances could pose a risk to or via the aquatic environment for a longer 
period, although the precise risk cannot be quantified. 
                                                
 
9  Biota refers to any groups of living aquatic organisms that can be analysed and used as indicators of 
pollution such as fish, mussels, invertebrates, etc. 
 
EN 11   EN Despite the current failures - largely for substances that persist in the environment and/or 
undergo long-range transport - ther e is evidence that the con centrations of some PS, e.g. 
Mercury, have decreased in some countries, e. g. DE, since they were first listed in 200110, 
even though the EQS were not set until 2008.  Listi ng in itself appears to have contributed to 
increased awareness of the need to take cont rol measures, and, importantly, is providing the 
monitoring data required to assess the effectiveness of the measures. Timely compliance with 
the EQS in the EQSD is expected to in crease as technical advances are made. 
2.2. What is the issue or problem requiring action? 
2.2.1.  General points 
It is clear from monitoring data that chemical pollution of water bodies remains an important 
issue to be tackled at all levels.   Tens of t housands of chemicals are used daily in the EU for 
multiple purposes11. Some are active at very low concen trations and therefore difficult to 
detect in water. Substances of concern may be of synthetic or natural origin, and be produced 
deliberately or unintentionally. They  may be released into the aquatic environment, directly or 
indirectly, during one or more phases of th eir lifecycle, from pr oduction through use to 
disposal. They may show high direct toxicity to  the aquatic environment (microbial, plant or 
animal life) and/or pose a risk principally via secondary poisoning because  of their persistence 
and bioaccumulation, e.g. in humans via the cons umption of fish and shellfish. Their effects 
may be acute and/or chronic. For example, the presence of brominated diphenyl ethers (BDEs) (existing PS) in cord blood has b een linked in epidemiological studies with 
neurodevelopmental effects in infants; and ne urodevelopmental effects, altered habituation 
patterns, hyperactivity, learning and memory defic its have been seen in  animal studies with 
BDEs (Herbstman et al 2010; Costa et al 2011). 
2.2.2.  Summary of main issues/problems 
In the context of the required review, and noting already the need to consider particularly the 
substances in Annex III of the EQS Directive, the main issues to take into account are  
(i) the availability of  new information about risks caused by existing PS and new chemicals,  
(ii) the fact that some  of the most harmful chemicals alre ady on the PS list or proposed for 
addition are ubiquitous persistent, bioaccumulati ve and toxic (PBT) substances and, despite 
being already heavily regulated , will produce widespread failu res of the objective of good 
chemical status for many years due to their intr insic characteristics, especially if the EQS is 
set in biota instead of water to improve detection, and  
(iii) the fact that there is a paucity of f it-for-purpose monitoring data on which to base 
assessment of exposure
12 and thus the prioritisation of  new PS in future reviews.   
                                                 
10  Decision No 2455/2001/EC of the European Parliament and of the Council of 20 November 2001 
destablishing the list of priority substances in the field of water policy and amending Directive 
2000/60/EC [OJ L331 of 15.12.2001, p.1] 
11  http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Chemicals_management_statistics  
12  In the context of risk assessment “exposure” refers to the amount of contaminant (dose) that an 
individual or the population will recei ve. This is compared with the pr edicted no-effect concentration to 
perform the risk assessment.  
 
EN 12   EN 2.2.3.  New information on risks to environment and human health 
A range of new information was reviewed, in cluding data on ecotoxicity, environmental 
concentrations, production and use, and assessments of persistence, bioaccumulation, carcinogenicity, mutagenicity, reprotoxicity and endocrine disrupting potential.  This 
information pointed to concerns regarding a num ber of substances not yet identified as PS, 
and to a need to review the status and/or EQS of  some existing PS. It also pointed to the need 
to consider deriving EQS for the identified substances in a specific matrix
13. 
The selection of possible new PS was conducte d using the approaches outlined in WFD 
Article 16(2).  These included taking account of  risk assessments under other legislation (in 
particular the chemicals, plant protection prod uct (PPP) and biocides legislation), and the 
assessment of intrinsic hazard and exposure accord ing to a simplified risk-based assessment.  
As part of the latter, parallel monitoring and modelling-based risk ranking exercises were 
undertaken, starting with  lists of approximately 1000 and 2000 substances, respectively. The 
prioritisation led to a list of 15 possible new PS.  Some information on them is provided in the table below.  Further information (including th e EQSs derived) is provided in Annexes II and 
V. Although several other substances were ac knowledged to be of concern, the risk was 
judged lower or the evidence for listing them at this point was not as strong or complete. 
Many of the 15 substances (e.g. Dioxins, HBCDD, PFOS) are persistent and/or 
bioaccumulative as well as toxic,  and are therefore likely to remain in the environment for 
decades and/or affect birds and/or mammals  including humans via secondary poisoning. A 
number of others (e.g. Cypermet hrin, Dichlorvos) are characteris ed by their acute toxicity. 
For some toxic substances, chronic effects ma y be more important than acute effects, 
depending upon how the concentrations of th e substance in water vary, and upon the 
organisms affected.  Some of the substanc es show evidence of probable or possible 
carcinogenicity in humans (e.g. Dioxins, Dicofol) , others are known or suspected endocrine 
disruptors (e.g. Heptachlor, the Estradiols). 
National standards exist for some of the substances in a number of MS; further details are 
provided in Annex II.  The monitoring database  referred to was compiled for the review.  
Table summarising in formation on the 15 possible new PS: 
Substance Type/Use  Concern State of play in MS 
17 alpha-
ethinylestradiol 
(EE2) Pharmaceutical; synthetic 
steroid hormone used 
mainly in oral 
contraceptives.  No production data available. 
Approx 32 million women 
in EU use EE2-based 
contraception. Endocrine disruptive; prolonged 
exposure to low concentrations of 
EE2 has been shown to cause sex 
changes, alterations in reproductive capacity, and ultimately population 
collapse in fish (Kidd et al, 2007)   Monitoring database 
contains data from 3 
countries, 2 showing 
exceedance of EQS, 1 likely exceedance; 
literature predicts 
exceedances more 
widely. 
17 beta-
estradiol (E2) Steroid hormone: excreted  naturally (approx 90%) in human and livestock urine 
but also (<10%) as a result 
of pharmaceutical use (of which 90% from HRT). Endocrine disruptive; chronic studies 
show effects on sexual development and fecundity in fish. Monitoring database (2 
countries) and literature show 
exceedance of EQS. 
Aclonifen Herbicide, used on a range Toxic to a range of aquatic National standard 
                                                 
13  Matrix refers to water, sediment or biota, the three compartments of the a quatic environment in which 
contaminants can be measured.  
 
EN 13   EN of arable crops. 
Use > 1000 tonnes/yr. organisms. exists in SE. 
3 countries in 
monitoring database, FR data predominant 
and showing 
exceedance. Authorised in 18 MS. 
Bifenox Herbicide, used to kill 
broadleaf weeds in cereal 
crops and grassland. Use > 200 tonnes/yr. Toxic to a range of aquatic 
organisms. 3 countries in 
monitoring database; 
FR data predominant and showing 
exceedance. 
Authorised in 19 MS. 
Cybutryne (Irgarol®) 
 Biocide used as antifouling 
agent in coatings for boat 
hulls etc. 
Use approx 10 tonnes/yr. Toxic; degrades only slowly and 
main degradation product (M1) also 
toxic; persists in sediments. National standard 
exists in SE. 
4 countries in 
monitoring database; exceedance or near 
exceedance of EQS in 
3. 
Cypermethrin 
 Insecticidal pyrethroid 
plant protection product 
(PPP)  and biocide, used in arable farming, salmon 
farming, sheep dipping and 
wood preservation.  Use up to 100 tonnes/yr. Toxic to a range of aquatic 
organisms. Benthic invertebrates 
vulnerable because cypermethrin binds to sediment
14. Use in the 
marine environment is authorised in 
a few countries of the world but prohibited in Canada
15 where 
suspicion exists regarding a possible 
link with the death of lobsters 16, the 
sensitivity of which has been 
assessed (e.g. Burridge et al 2000). National standards 
exist in 2 MS (DK, 
UK). 3 of 5 countries in 
monitoring database 
show exceedance of EQS; analytical 
method may have 
missed others. 
Dichlorvos Organophosphorus 
insecticide and biocide, used in grain/nut stores, 
insecticidal sprays/strips. 
Use – a few kg to a few tonnes/yr in different MS; 
probably closer to lower 
figure since 2008 when decision on non-
authorisation as PPP took 
effect.  Toxic particularly to aquatic 
invertebrates and fish; possibly carcinogenic to humans. (No longer 
authorised as PPP.) National standards 
exist in 4 MS (BE, DE, IT, NL); IE simply 
monitors. 
Monitoring database shows exceedance of 
EQS in 7 of 9 MS; 
analytical method may have missed others. 
Diclofenac Pharmaceutical, used as 
NSAID. 
Average consumption 0.46 g/person/yr. Toxic, directly (e.g. chronic studies 
show effects on gills and kidneys in 
fish), and via secondary poisoning, e.g. vultures in India affected by 
veterinary use in cattle. Monitoring and 
predictions show 
exceedances of the EQS in water in 7 MS 
Dicofol Organochlorine PPP, until 
recently authorised for use on fruit and vegetable 
crops. 
Possibly residual use. Toxic; similar to DDT, 
recommended for designation as POP (Stockholm Convention); 
possibly carcinogenic to humans, 
possibly endocrine disruptive. Monitoring database 
shows failure of EQS in ES and FR, likely 
elsewhere. 
Dioxins (and Dioxins: by-products of PBTs, POPs (Stockholm Convention National standards 
                                                 
14  http://www.scotland.gov.uk/Publications/2002/08/15170/9409   
15  http://www.worldw ildlife.org/what/globalmarkets/a quaculture/WWFBinaryitem8842.pdf   
16  http://www.cbc.ca/news/canada/new-brunswick/stor y/2010/02/18/nb-aquaculture-pesticide-bay-of-
fundy-lobster-deaths-658.html   
http://quoddytides.com/salmon10-8-10.html ,  
 
EN 14   EN dioxin-like 
PCBs)   thermal combustion 
PCBs: chlorinated organic 
compounds formerly used to manufacture electrical 
equipment etc.; some also 
produced by combustion. and CLRTAP). Some congeners 
probably carcinogenic to humans; 
other possible effects include endocrine disruption, impairment of 
immune system, nervous system, 
reproduction.  Limits already set for presence in feed and food.  Baltic 
salmon not for export because dioxin 
limits exceeded. exist in 3 MS (DK, IT, 
SE). IE simply 
monitors. Several MS report 
likely exceedance of 
EQS. 
HBCDD Industrial chemical, used 
as flame retardant, 
especially in polystyrene, 
including insulation boards. 
Use up to 10000 tonnes/yr. PBT, SVHC under REACH, 
recommended POP. Possibly toxic to 
reproduction in humans. National standards 
exist in 2 MS (DK, 
SE). 
Monitoring data mainly from literature 
show exceedances of 
EQS. 
Heptachlor/ Heptachlor 
epoxide Organochlorine insecticide, 
no longer authorised but 
secondary emissions 
possible. POP; very toxic to aquatic 
organisms; possibly/probably 
carcinogenic to humans, possibly 
endocrine disruptive.. National standards 
exist in 6 MS (AT, BE, 
IT, RO, NL, DE); CY 
and IE simply monitor. 
Monitoring database 
shows exceedance of biota EQS in at least 3 
out of 6 MS and of 
corresponding water EQS in at least 6 out of 
12 MS; analytical 
method may have missed others 
PFOS Industrial chemical, used in 
hydraulic aviation fluids, 
photography, electroplating.  
Use – 100s of tonnes in 
2000, less since 2008 but present in many existing 
products, especially 
textiles. PBT, POP. Toxic to animals 
especially mammals. Possible 
carcinogen in humans; possible effects on thyroid function.. National standards 
exist in 3 MS (CZ, DK, 
SE). 4 countries in 
monitoring database, 
all showing exceedance of EQS 
Quinoxyfen Fungicide, used mainly on 
cereals, grape vines. 
Use approx 70 tonnes/yr. PBT and vPvB properties. 
Accumulates particularly in 
sediments. Monitoring data from 2 
MS; some exceedances 
of EQS in FR. 
Authorised in 17 MS. 
Terbutryn Biocide, used especially in 
coatings for buildings, as 
preservative. Use approx 200 tonnes/yr. Toxic especially to algae and aquatic 
plants.. National standards 
exist in 2 MS (BG, 
CZ). 5 countries out of 9 in 
monitoring database 
show exceedance of EQS 
The reasons for reviewing the EQS and/or status for some existing PS (Anthracene, 
PolyBDEs, DEHP, Lead, Naphtha lene, Nickel, PAHs, Fluoranth ene and Trifluralin) are 
explained in Annex II.  In most cases, a (re vised) EU Risk Assessment Report (RAR) had 
become available since the existing EQS was established. 
 
EN 15   EN 2.2.4.  Specific difficulties with ubiquitous persi stent, bioaccumulative and toxic (PBT) 
chemicals 
2.2.4.1.  Introduction 
By definition, PBTs persist in the environmen t, bioaccumulate in the trophic chain and are 
toxic. They are classified in the WFD as Pr iority Hazardous Substances (PHS). Some are 
Persistent Organic Pollutants (POPs) capable  of causing long-range transboundary pollution. 
They are largely ubiquitous and are found even in remote areas, far away from any human 
activity (e.g. BDEs in remote alpine lakes in Austria; brominated flame retardants, organohalogens and perfluorinated com pounds in the Arctic – see AMAP 2009). 
The measures already taken regarding seve ral existing PBTs have reduced emissions 
significantly.  In addition, the REACH Regulati on is now providing a m echanism to identify 
PBTs as substances of very high concern (SVHC) and, where they are included in Annex 
XIV, they become subject to authorisation, wh ich ensures their progre ssive substitution on the 
market with less hazardous substances, where this is economically and technically feasible. However, their existing concentrations, particular ly in sediment and/or biota, could still pose a 
risk to the aquatic environment and/or to hum an health via the aquatic environment, and 
natural recovery will generally take decades. 
Because of their properties, re gulation of these substances under the WFD poses particular 
problems. Three issues or sub-pr oblems need to be considered, as  follows. Full explanation is 
provided in Annex III. 
2.2.4.2.  Presentational issues related to  large proportion of EQS failures 
Surface waters are assessed in the WFD for thei r overall chemical status against all the EQS 
for PS, including the ubiquitous PBTs.  Maps have to be produced for the RBMPs showing 
the chemical status of each RBD. A bad situa tion for some chemicals can therefore hide 
positive situations for other substances. The ma ps may then be dominated by failures about 
which little more, if anything, can be done fr om the water management perspective.  
It is obviously important that the extent of  the PBT problem be clarified and acknowledged, 
not hidden. However, the influence of these substances on the assessment made under the 
WFD seems disproportionate in relation to the possibilities for the policy to deliver reductions 
in their environmental concentrations within the WFD timeframe.  
2.2.4.3.  Choice of monitoring matrix  for compliance checking 
The EQSD includes the flexibility  for MS to choose the matrix to monitor the PS. For most 
PS, EQS for water are given in Annex I of th e EQSD, but MS can choose to develop and use 
sediment and/or biota standards that offer at  least the same level of protection as those 
provided for water. For three substances (Mercury, Hexachlorobenzene and Hexachlorobutadiene), EQS for biota are given in the EQSD
17 that MS have to use unless 
they develop and apply a water standard that o ffers the same level of protection as the biota 
                                                 
17  These substances are hydrop hobic and bioaccumulative and ther efore the preferred matrix for 
monitoring is biota; their concentrations in water are so low that are rarely meas urable using state of the 
art analytical techniques. The main exposure route posing a risk is secondary poisoning, i.e. risks to 
human health via ingestion of contaminated fish or shellfish. 
 
EN 16   EN standard. Most of the ubiquitous PBTs (and some other substances) are very hydrophobic. It 
is therefore difficult to monitor them in water.  The analytical technique s available are rarely 
sensitive enough to reliably detect concentrations of the order of the EQS, as the EQS is itself 
very close to (or below) the limit of determin ation. This means that where the results of an 
analysis are below the limit of determination, th e concentration in the sample may still be 
higher than the EQS. Commission Directive 2009/90/EC requires MS to use analytical 
techniques that meet certain minimum quality re quirements in relation to the EQS, but it also 
establishes that if the analytical techniques don't meet those minimu m criteria, the best 
available techniques not entailin g excessive costs should be used. Because of this clause, 
some MS are applying water standards for certain substances even though they are not able to 
monitor at the level of that EQS. This allows them to conclude that "there is no problem", 
even though the application of a sediment or biota standard  (set at more measurable 
concentrations) might reveal extensive failure. Although legally  possible within the current 
legislative set-up, it is clearly unacceptable that water bodies are categorised as having "good 
chemical status" while they contai n elevated values in sediment and/or biota that pose a risk 
to or via the aquatic environment, and unacce ptable that the use of different methods by 
different MS leads to different reporting of similar situations. 
The tendency for MS to monitor in water is clear  from the data gathered for the prioritisation 
database; only 11 MS provided data for biota,  only 12 for sediment, but all 27 for water. 
Knowledge and methodologies to develop EQ S for sediment and biota have evolved 
significantly, and it is now possible to derive  standards for these matrices (SCHER, 2010). 
However, this expertise is not available in all MS. Although this issue of the choice of matrix 
applies most obviously to substances identified as ubiquitous PBTs, it ma y apply to others as 
well. 
2.2.4.4.  Reduced monitoring effort for ubiquitous PBTs 
An additional issue that has been raised by MS in relation to these substances is the 
monitoring requirements. The WFD (Annex V) and EQSD set minimum monitoring 
requirements which are adapted to the RBMP cy cle. For ubiquitous PBTs, any change in 
environmental concentrations that might occur as  a result of measures is likely to occur over 
the long term (unless remediation is carried ou t) and therefore a lower monitoring frequency 
would seem justified and possibly also a reduction in the number of monitoring sites.  If MS 
choose to use a sediment or biota standard, the default monitoring frequency is already lower.  
The issue is how, for ubiquitous PBTs, the m onitoring frequency can be optimised to 
minimise the administrative burden while  still yielding sufficient information. 
2.2.5.  Knowledge base  
2.2.5.1.  Introduction 
The process of identifying PS and setting EQS for them relies on the availability of a range of 
information.  Data are needed on 
o Intrinsic properties of the substances  and their (eco)toxicological effects 
o Exposure, i.e. environmenta l concentrations, preferably  measured but otherwise 
reliably modelled on the basis of producti on volumes, use patterns and/or emissions. 
Although a vast amount of monitoring data was gath ered for the current re view of the PS list, 
constituting a very significant improvement in re lation to the last prioritisation exercise, and 
 
EN 17   EN although other sources of information including modelling were used in the prioritisation 
process (as recommended by the Scientific Committee on Toxicity, Ecotoxicity and the 
Environment18 following the previous exercise) to  avoid missing substances not already 
monitored, the process was to some extent still hampered by the relative paucity of 
monitoring data for some subs tances, including the unevenness of data collection across the 
EU. This prevented the proper asse ssment of the risk posed by so me substances that otherwise 
might have been considered for prioritisation. There is a vicious  circle: unless a substance is 
already regulated, it is unlikely to be widely monitored – but if it is not monitored and the 
environmental concentrations cannot be reliably  modelled either, estimat ion of the risk posed 
to and via the aquatic environmen t at EU level may not be robust enough to justify regulation.  
Since the listing of a substance implies an oblig ation to monitor (i.e. an administrative cost) 
and to take measures, it is not efficient to list substances that  don’t pose a risk ; at the same 
time, uncertainty could lead to some substances  not being identified as PS that should be. The 
situation is particularly difficult for emerging pollutants (see Annex III). 
Another issue of concern for some substances is the quality of the monitoring data that are 
available.  As indicated in section 2.2.4.3 on the issue of the monitoring matrix, certain 
substances occur at very low concentrations below the determination limit of the available 
analytical methods, but potentially still abov e the no-effect level.  Despite monitoring, 
uncertainty may therefore remain regarding whet her the concentrations in the environment are 
likely to be harmful.  The monitoring data for a number of PPPs (which are active at very low 
concentrations because of their high toxicity) ar e often inadequate in this respect, since the 
determination limit is higher than the no-effect level. 
Although research is an obvious source of information on new risks, the information is 
usually scattered and does not provide an EU pict ure; it is therefore not always sufficient for 
prioritisation.  
2.2.5.2.  Specific problems to address 
The main issues that need to be addressed are therefore the 
o lack of a clear mechanism for collecting info rmation at EU level, i.e. although Article 
3 of Decision 2455/2001/EC speci fies that "MS shall ensure  that the substance and 
exposure-related data needed for the im plementation of the COMMPS procedure are 
made available", some MS provide a lot of data and some very little; 
o lack of EU representativeness of monitori ng data, e.g.. 80% of the database compiled 
for the present review comes from two MS; data for many substances (more than 800 
out of the 1150) come from 3 countries or fe wer; only for 30 substances do data come 
from more than 18 countries; 
o need for more consistent implementati on by MS of WFD pressures and impacts 
analysis – which should act as a common driver for the monitoring of  substances 
posing a risk; 
o bias towards monitoring pollutants that are already regulated, meaning that for certain 
substances, in particular the emerging pollu tants, monitoring data are sparse, even 
though evidence exists that among them th ere are a number that may pose a risk; 
o quality of the monitoring data, i.e. the need  for analytical techni ques to be used that 
are sufficiently sensitive to determine concentrations at the no-effect level, so that the monitoring data are "fit for (the ) purpose" of prioritisation. 
                                                
 
18  Former Scientific Committee replaced by SCHER 
 
EN 18   EN  
2.3. What are the underlying drivers of the problem? 
For the possible new PS identified in the current review, the fact that there is a need to 
regulate them under the WFD probably results in  part from imperfection in the models and 
assumptions used in the implementation of the upstream legislation controlling their 
authorisation and use.  The WFD acts in that respect as a "safety net". 
In the specific case of pharmaceuticals, one signif icant source of emissions is the disposal of 
unused pharmaceuticals. Although EU legislation ob liges MS to establish take-back schemes, 
it does not impose reporting obligations or effi ciency targets. There are therefore no 
comprehensive data on the functioning of th e schemes, despite a recent survey by the 
European Federation of Pharmaceutical Industrie s and Associations (EFPIA). What is clear, 
though, is that a significant quantity of unused dr ugs are discarded into the sink or toilet and 
therefore end up in surface waters;  10 to 43% of interviewees in different MS discard 
medicines in this way (Knappe, 2008). The am ount of pharmaceuticals collected in various 
European countries varies significantly, generall y in the range of 10 to 100 tonnes per million 
inhabitants per annum. The rate is very hi gh in Switzerland followed by Ireland, Luxembourg, 
Sweden and France (EEA 2010).   
Improper disposal could be a significant so urce of pollution by Diclofenac given its high 
usage and potentially high quantities of unused doses (due to end of treatment, medication 
change, non-compliance with prescription, or expi ry). One 10-tablet blister of a typical 50 mg 
dose can pollute up to 5 million litres of water with concentrations above the EQS, i.e. a 
volume equivalent to the wast e water generated daily by a town of 20 000 inhabitants.  
Improper disposal of unused EE2 could also be a significant source of pollution, considering 
that a single blister of pills for one mens trual cycle with the most common dose of 30 μg has 
the potential to pollute to concentrations above  the EQS 24 million litres of water, equivalent 
to the waste water generated daily by  a city of 100 000 inhabitants.  
For the existing PS, the need for reassessment ar ises because knowledge at the time they were 
listed did not support sufficiently stringent  EQS, nor proper status (as PHS).  
More generally, chemical pollution of the enviro nment, including of the aquatic environment, 
is almost certainly aggravated by the fact that  users of the chemicals do not bear the cost of 
pollution, i.e. there is a market failure.  Related to this is the fact th at conventional urban 
waste water treatment is not cap able of adequately removing all the pollutants, and installing 
tertiary treatment on a widespre ad basis would be expensive. 
In relation to the problems desc ribed for ubiquitous PBTs, it is clear that historic pollution 
accounts for much of the contamination that exis ts and therefore for the difficulties faced by 
MS in achieving good chemical status. The relativ ely uniform (with respect to type of PS) 
requirements of the WFD and EQSD app ear to aggravate those difficulties. 
The difference in choice of EQS (and monitoring)  matrix made by MS that results in very 
different assessments for the same substance (especially ubiquitous PBTs) arises in part because the EQSD and the Commission Directiv e 2009/90/EC on technical specifications for 
chemical analysis do not provide enough guidance to limit the choice.  
 
EN 19   EN Finally, the paucity of high-quality and fit- for-purpose monitoring da ta to support the 
prioritisation exercise appears to result prin cipally from the absence of a clear, targeted 
mechanism to gather such data. 
2.4. Who is affected by the problems identifi ed, in what ways and to what extent? 
As acknowledged in the WFD, water is not a commercial product like any other but, rather, a 
heritage which must be protected. At the sa me time, it is indeed a key economic resource.  The 
increasing economic development of Europe ha s not only increased th e dependence on water 
resources but also in many areas created more intensive pressures on them, in particular on 
their quality.  Many surface waters are used as sources of drinking water (60% of the water 
abstracted in the EU for the production of drinking water comes from surface water) and of 
water for a range of domestic, industrial, agri cultural and aquacultural purposes.  They also 
serve as receptors for waste including industrial and domesti c sewage effluents, and many 
receive a range of pollution from diffuse sources such as run-off from urban and agricultural 
areas, leachate from landfills and mine workings, and atmospheric deposition.  
Where the objective of good chemical status is not met, the concentrations of at least some PS 
in the relevant water bodies are likely to be above no-effect levels and therefore a risk to the 
aquatic environment and/or to human health th rough the aquatic environment, for example via 
the consumption of drinking water, fish or sh ellfish. Achieving good status is likely to 
become increasingly challenging in the context of climate change, which is likely to result in more frequent incidences of low river flows and depleted lakes and reservoirs (EC, 2009) 
therefore leading to a higher concentration of pollutants. 
Surface waters in situ  that support a healthy aquatic ecol ogy are key for biodiversity. Around 
70% of the protected habitats and species in  EU legislation are wa ter related. Chemical 
pollution can reduce the richness of the aquatic  ecosystem and, consequently, its functionality, 
hence decreasing its resilience, it s capacity to handle pollution (Cardinale 2011).  At the same 
time, the amenity value of wate r bodies as features of the la ndscape that support recreational 
activities such as angling, sw imming and boating is reduced. 
The potential effects of the 15 possible new PS ar e outlined in section 2.2. 3 (see also Annexes 
II and V for details). Because those effects, a nd likewise the effects of the existing PS, are 
relevant to society as a whole,  they are obviously also direct ly or indirectly relevant to 
industry.  The industry sectors that produce or use the possible new PS are indicated in the 
"Type/Use" column of the table in section 2.2.3. In addition to them, the water and sewerage 
treatment industry is inevitably concerned by the presence of chemical substances (in general) 
in water bodies. In the context of implementi ng the EQSD, it is the Member State Competent 
Authorities on whom the obligation to meet the EQS for PS falls. 
2.5. How would the problem evolve, all things being equal? 
The three main problems identified would be exp ected, if no proposal were made, to evolve as 
described below.  
2.5.1.  New information on risks to environment and human health 
For the substances identified in this review (existing and new PS), the baseline situation, in 
terms of production, use and emissions, is in most  cases subject to sign ificant uncertainty for 
several reasons. The most important is that seve ral pieces of legislation are already in place 
 
EN 20   EN that will or may have an impact on the use an d emissions of some of the substances in the 
coming years, and therefore on their concentrati ons in the aquatic environment.  The most 
important of these are the WFD Programmes of  Measures, the PPP legi slation including the 
Directive on the sustainable us e of pesticides, .the REACH Re gulation, industrial emissions 
policy, and the legislation on biocides, pharmaceu ticals, waste and POPs. Some information 
on which substances are subject to the legislation, and on the im plications, is provided here; 
further details are in the tables in section 5.2 and in Annexes V and VI.  
Decisions under the other legislat ion are likely to lead to decr eased emissions to water or no 
change. In some cases, decisions are awaite d on status (e.g. as a POP) or on continued 
authorisation (e.g. as a biocide), and they might go either way. For example, a decision not to 
exclude a particular biocide fr om Annex I to the Biocidal Pr oducts Directive in the current 
review would mean no change.  Fu rther, even where a decision is  made to restrict use, the 
measure might have greater or lesser effect de pending upon its scope. In the example of the 
biocides, exclusion might not apply to all of the currently authorised product types. Even 
though recommendations exist regarding the non- authorisation or POP designation of some 
substances, the final decisions cannot be considered foregone conclusions. 
 
Legislation in 
baseline  Developments/general implications Releva nt substances/specific implications 
WFD 
Programmes of 
Measures in MS MS currently defining measures for 
existing PS and RBSP on basis of 2009 
RBMPs and Programmes of Measures.  Due to be operational by end 2012; 
reporting of impacts in 2015. All existing and proposed PS – uncertainty 
regarding the implementation of MS measures 
for existing PS and relevant RBSPs, and the possibility that the measures might affect more 
than the targeted substances, including (other) 
possible new PS.  
Of 15 proposed PS, 10 are RBSP, therefore 
already subject to measures (see Annex VI), but in 8 cases in only 1 to 3 MS. 
Plant Protection 
Products (PPP) 
legislation, especially the 
Sustainable Use 
of Pesticides Directive but 
Regulation (EC) 
No 2009/1107 National Action Plans due by end 2012; 
measures - to be introduced 2013-2015 
– not yet defined. Authorisation of individual active 
substances subject to periodic review; 
new information could change authorisation, and the Regulation also 
contains new criteria regarding 
PBT/vPvB substances. Aclonifen, Bifenox, Cypermethrin, Quinoxyfen, 
- uncertainty regarding measures from NAPs 
and/or outcome of authorisation review.  
Increasing likelihood of MS specifying buffer 
strips as well as other measures under Sustainable Use Directive; could decrease 
concentrations in water bodies. Aclonifen - EU-
level requirement since 2008 for buffer strips. 
Quinoxyfen – authorisation under Directive 
91/414/EEC due to be reviewed in 2014 under the Regulation; conditions or withdrawal 
possible. 
(PPP legislation also relevant to Dichlorvos, Dicofol, Terbutryn, Trifluralin – but these are no 
longer authorised as PPPs.) 
Biocidal Products 
Directive 98/8/EC Review programme ongoing covering 
23 different types of biocides – could lead to change or withdrawal of 
authorisations. 
Tigher restrictions on industrial use of creosote due to take effect May 2013. Cybutryne  (1 product type), Cypermethrin (3 
product types, Dichlorvos (1 product type), Terbutryn (3 product types) – uncertainty 
regarding outcome of review. 
Creosote restrictions relevant to Anthracene, Fluoranthene, Naphthalene, PAHs. 
REACH 
Regulation Registration process ongoing; may bring 
new information and potential action, Existing PS: Anthracene, DEHP, Fluoranthene, 
Lead, Naphthalene,  Nickel, PAHs; 
 
EN 21   EN even in the near future, on 
existing/proposed PS. 
In addition, substances may be added to SVHC candidate list and then Annex 
XIV (the authorisation list) with a 
sunset date but possible exemptions for specified uses. 
REACH cannot affect emissions from 
existing products. Proposed PS: HBCDD, PFOS 
 
 – uncertainty regarding extent/impact of possible regulation for reasons given below. 
 
Registration dossiers for the existing PS still to be assessed. 
DEHP and HBCDD – in Annex XIV, sunset 
date 2015; not yet known which uses will be authorised.  (Leaching from existing products 
containing these substances  not directly affected, 
e.g. of DEHP from existing textiles, furniture and PVC construction materials such as 
flooring, roofing, piping; of HBCDD from 
insulation materials in situ  and on disposal; but 
extent could change depending upon how long 
new use continues.) 
PFOS – in Annex XVII; not certain how quickly technical advances will allow substitution of 
PFOS for the derogated uses 
Anthracene (and related oils, pastes) and coal tar 
pitch high temperature (relevant to Anthracene, 
Fluoranthene, Naphthalene, PAHs) are on the SVHC candidate list. Not certain what the 
outcome of their further review will be. 
POPs legislation: 
Stockholm Convention
19, 
POPs Protocol to 
UNECE CLRTAP
20, and 
Regulation (EC) 
No 850/200421 Under Stockholm Convention, for 
existing and new POPs, measures must be taken to either eliminate production 
and use (some exemptions possible) 
(Annex A), restrict production and use (Annex B), or reduce unintentional 
releases with the goal of eliminating 
them altogether (Annex C). Measures and/or exemptions could change. Existing POPs - uncertainty regarding 
implementation/effectiveness of measures especially where complete phase-out of use not 
yet possible: 
Existing PS: some polyBDEs (tetraBDE, pentaBDE, hexaBDE, heptaBDE) (Annex A); 
Proposed PS: Heptachlor, PCBs (Annex A), 
PFOS (Annex B), Dioxins (Annex C) Measures for the BDEs and PFOS were 
agreed in 2010 and should significantly reduce 
emissions to the aquatic environment, but timeline for substitution of PFOS uncertain 
Possible POPs – uncertainty regarding listing: 
Trifluralin (existing PS), Dicofol and HBCDD (proposed PS)  
EC Regulation addresses some other substances, 
i.e. PAHs are subject to release reduction 
provisions (relevant also to anthracene, 
fluoranthene, naphthaleme.) 
Industrial emissions 
Directive 
2010/75/EC (IED) – recast of 
Integrated 
Pollution Prevention and 
Control (IPPC) 
Directive IED regulates industrial emissions to 
water and other environmental media 
including by integrated permitting for a 
wide range of industrial sectors, with emission controls based on Best 
Available Techniques (BAT). 
Implementation of IED as of 2011 likely to strengthen BAT and could therefore 
affect baseline for industrial chemicals 
discharged by industries  Potentially all substances but particularly 
industrial chemicals disc harged by industries, 
i.e.: 
Existing PS: Anthracene, DEHP, Fluoranthene, Naphthalene, Nickel, Lead, PAHs. 
Proposed PS: Dioxins and DL-PCBs, HBCDD, 
PFOS - uncertainty regarding changes to BAT 
implementation given that transposition date of 
IED likely not to be uniform, renewal of permits likely to follow different timetables, and new 
                                                 
19  http://chm.pops.int/Convention/ThePOPs /tabid/673/language/en-GB/Default.aspx ;  
20  http://www.unece. org/env/lrtap/pops_h1.htm   
21  http://eur-lex.europa.eu/LexUriServ/LexUriSe rv.do?uri=OJ:L:2004:229:0005:0022:EN:PDF   
 
EN 22   EN approach to BAT not effective until 2014.. 
Waste legislation 
– several acts and 
decisions Latest Commission implementation 
report on EU waste legislation 
recognises progress but also important gaps. Further progress likely – could 
affect emissions to  water from waste 
handling and/or disposal. Several substances could be affected. – 
uncertainty regarding specific measures. 
 As an example, most recently, the Commission 
has announced that it  intends to propose limits 
on the amount of the two POPs (polyBDEs and PFOS) in waste
22. 
Pharmaceutical 
legislation Commission study to be launched 2011 
building on existing information on the 
impact of pharmaceuticals on the aquatic environment. The impact of this 
Commission initiative is uncertain but 
could be significant in the long term. Diclofenac, E2, EE2. – uncertainty regarding 
MS action on take-back schemes and outcome 
of Commission study. 
Other legislation Rotterdam Convention: a substance 
listed in Annex III becomes subject to 
the Prior Informed Consent (PIC) 
procedure23. A recommendation to include PFOS, pentaBDE 
and octaBDE in Annex III will be considered in 
2013 – uncertainty regarding outcome. 
(PCBs, heptachlor and some other existing PS are already listed.) 
With regard to the Programmes of Measures and the RBSPs covered under ecological status, 
it is clear that a lthough 10 of the 15 proposed PS are designated as RBSPs, this only applies in 
a few MS. This suggests that only a few MS woul d act on those substances in the absence of a 
proposal to list them as PS24, although it is not possible to pr edict which substances the MS 
will identify as RBSPs in their updated RBM Ps in 2015.  Less action could mean more 
frequent exceedance of no-eff ect levels. In the few MS wher e proposed PS have already been 
designated as RBSPs, a reduction in the risk to and/or via the aquatic environment would be 
expected, depending upon the extent to which m easures are taken to reduce concentrations 
below their current levels and on the level of th e quality standard set by the MS.  As has been 
found for other RBSPs, considerable variation be tween MS is observed, both in terms of the 
magnitude of the standard and the chosen ma trix (see Table in Anne x VI), meaning that 
without the harmonised EQS derived for each s ubstance as a PS, different baselines would 
likely be seen in the different MS. Some of th e standards are significantly less stringent than 
being proposed here. 
In the absence of a proposal to list the possi ble new PS in the EQSD, the baseline scenario 
would include almost no monitoring of those s ubstances in the aquatic environment.  Most 
would only be monitored in the few MS wher e they are listed as RBSPs.  Under the 
Stockholm Convention there are some non-bind ing recommendations for the monitoring of 
POPs; and Regulation (EC) No 850/2004 Articl e 9 requires "appropriate programmes and 
mechanisms" to be established for the regular provision of comparable monitoring data on the 
presence of Dioxins and PCBs in the envir onment, though no specifications are given. The 
limited extent of ba seline monitoring of the proposed PS w ould make it difficult to judge the 
effectiveness of the measures being taken under the Programmes of Measures or other (non-
WFD) EU legislation, and thus to adjust them  if necessary, and difficult to determine where 
remediation might be necessary. In addition, if the proposed PS were not listed as such, 
                                                 
22  http://ec.europa.eu/envi ronment/waste/studies/p df/POP_Waste_2011.pdf   
23  http://www.pic.int/Procedures/PICProcedur e/tabid/1364/language/en-US/Default.aspx   
24  This is based on information from 19 MS. Although it is early to extract conclusions from the RBMPs 
(their assessment is on-going), it is clear that ther e is a wide diversity of methodologies and likely an 
implementation gap in the identification of substances of river basin importance in the context of 
ecological status.  
 
EN 23   EN decisions taken under the other re levant legislation might take less note of the risk to the 
aquatic environment and thus not lead to such effective measures. 
If no proposal were made to change the EQS of the existing PS where new information 
indicates that they should be more stringe nt, these substances could pose an unrecognised 
ongoing risk. In the case of Nickel , it was recognised at the time the original EQS was set that 
it was probably not protective enough and would ha ve to be revised. If the status of DEHP 
were not changed, too little attention might be pa id to emissions of this  reprotoxic substance 
into the aquatic environment from existing uses; the change is appropriate for an existing PS (by definition posing a risk to or via the aqua tic environment) recently included in Annex XIV 
of REACH. If the status of Trifluralin were not changed, there would be no effect on primary 
emissions since Trifluralin has not been appr oved for use as a plant protection product (PPP) 
in the EU since 2007, but the EU position in the POPs negotiations could be compromised, and there would be no strong driver to carry out sediment remediation. 
2.5.2.  Specific difficulties with ubiquitous persi stent, bioaccumulative and toxic chemicals 
This issue relates to the functioning of the EQ SD and is therefore not affected directly by 
other legislation other than the Directive 2009/90 /EC on technical specifications for chemical 
analysis. 
If there were no change, widespread pollution by some of the existing ubiquitous PBTs could 
hide improvements achieved for other substances in the second RBMP. In addition, if some of 
the policy options related to subs tances were realised  in the legislation (introducing stricter 
EQS for some existing ubiquitous PBTs and adding some new ubiquitous PBTs to the list of PHS), the second RBMP maps woul d likely show a worse pictur e than the first, giving. the 
impression that the chemical status in most if not all MS was getting worse rather than improving.  MS would, among other things, be faced with the significant administrative 
burden of having to explain and justify this in the plans and during the WFD public-
participation process.  The extent of this problem would depend on the option chosen for the 
substances. 
As regards the choice of the matrix, the current legislation does not pr ovide any incentive to 
improve the information base by choosing the most  appropriate matrix for substances such as 
ubiquitous PBTs.  In the absence of a proposal to  change the situation, MS could continue to 
monitor in water even when another matrix woul d be more suitable.  There would continue to 
be many false "good chemical status" reports, ha rmonisation would not be achieved, and there 
would be less scope for identifying and possi bly remediating highly contaminated sites. 
As regards the monitoring effort, departure from the minimum requirements in the WFD 
requires technical justification that some MS ma y not be in a position to elaborate.  MS would 
continue to monitor on the basis of the mi nimum requirements in WFD Annex V and in 
EQSD Article 3. These requirements might not be the most efficient for ubiquitous PBTs. 
This would result in a waste of resources. 
2.5.3.  Knowledge base 
Although the availability of m onitoring data for the current prioritisation was much better 
than for the first exercise, i.e. a much more substantial database was compiled this time, there were still limitations. 
 
EN 24   EN For future exercises, the implementation of  REACH and the PPP Regulation of 2009 hold the 
promise of providing some assist ance, although neither is likely to lead to the provision of 
targeted, EU-wide monitoring data relati ng for example to emerging pollutants. 
REACH implementation is likely to generate a wealth of information on intrinsic properties 
and effects; a mechanism will need to be put in  place to access and use it for the prioritisation. 
On the exposure side, the REACH evaluation tool  allows requests to industry for monitoring 
data for certain substances, but this mechanism will not provide systematic representative information across the EU. It might be a useful  source of information but only to complement 
EU-wide monitoring. In any case, this only refe rs to substances covered under the scope of 
REACH and will not cover all emissions (e .g. those emitted from existing consumer 
products). 
The second RBMP is expected to provide more information than the first on MS monitoring 
of RBSPs, but the extent of this is not yet clear.   Indications from the first RBMP reporting are that most of the MS have identified a very  limited number of specific pollutants. There is 
also no clear mechanism for the data itself to be reported at EU level. Unless the situation changes, reporting will be voluntary, and althoug h it could go into an EU database, it might 
still not be fit for purpose for th e reasons explained in section 2.2.5. 
2.6. Does the EU have the right to act? 
Water pollution has a very important transboundar y character. 60% of the EU territory lies in 
shared river basins (EC, 2007). Because of th is, and because many substances that cause 
pollution are used across the EU anyway, it is appropria te to set harmonised EQS for them at 
EU level where a significant risk to or via th e aquatic environment is identified. Apart from 
the wider protection, a more leve l playing field is ensured than  when only a few MS set an 
EQS or the national EQS are very different. 
The Union’s policy for controlling the pollution of  surface waters is set out in Article 16 of 
the WFD.  Articles 16(4) and (8) of the WFD provi de for the list of PS to be reviewed every 
four years and the EQS within two years after th e inclusion of new substances on the list.  
Article 8 of the EQSD provides for the review of the PS list combining in the same proposal 
the identification of the substanc es and the EQS. As regards th e problems of ubiquitous PBTs 
and the knowledge base, the proposals concern action aimed at improving the functioning of 
the existing legislation. 
3. O
BJECTIVES  
The obligations under the WFD are referred to in  previous sections. In line with those, the 
general objectives of the proposal are the following: 
− Reduce the risks to or via the aquatic environment posed by certain substances 
− Improve the functioning of the EQSD 
− Provide adequate tools to improve the future identification of substances of concern to 
or via the aquatic envi ronment at EU level. 
The specific objectives are the following: 
− Consider the latest scie ntific knowledge in the review of existing PS  
− Identify new PS and set EQS for them 
 
EN 25   EN − Ensure improved knowledge, through monitori ng, of the risks posed by existing and 
proposed PS and the effectiveness of measures  taken to reduce or eliminate emissions 
− Improve communication of the progre ss on water quality under the WFD  
− Strengthen the current legislation on the choice of the most suitable matrix for 
monitoring  
− Reduce the administrative costs for MS by providing additional flexibility in the 
monitoring of ubiquitous PBTs while mainta ining the effectiveness of the monitoring 
− Provide a mechanism to improve the knowledge base and make future identification of 
PS more effective 
 These objectives are compatible with the overa rching EU objective, reinforced in the Treaty 
of Lisbon, that the EU will work for the su stainable development of Europe based, in 
particular, on a high level of protection and impr ovement of the quality of the environment.  
4. P
OLICY OPTIONS  
4.1. Overview 
The options presented in this section addre ss one or more of the problems and objectives 
presented in sections 2.2 and 3. The table below shows the correspondence between the 
options and the problems, s ub-problems and objectives: 
 
Problem Sub-problem General objective Specific objectives Options 
Existing substances Consider  the latest scientific 
knowledge 
Ensure improved knowledge 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 pose 
risks and set EQS for them 
Ensure improved knowledge 
through monitoring  A3a-A3c 
Presentational issues Improve communication of 
progress on water quality under 
the WFD B2a-B2b 
Choice of matrix Strengthe n the current 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 the monitoring of 
ubiquitous PBTs B4a-B4b 
Knowledge base - Provide adequate 
tools to improve the 
identification of 
substances of concern  Provide a mechanism to improve 
the knowledge base and make 
future identification of PS more 
effective C2-C3 
 
The sets of options relating to ubiquitous PBTs  and the knowledge base are independent of 
the substance options and of each other.  
4.2. Policy options in relation to the substances 
4.2.1.  Introduction 
The policy options considered in this section re fer to the inclusion of substances as PS in 
Annex X of the WFD, the (re)determination of the status (PS or PHS) of the PS, and the 
revision or establishment of EU-w ide EQS for them.  If a substance is identified as a PS but 
 
EN 26   EN not a PHS, it can still be used, but the EQS should be met. For PHS, the WFD foresees the 
cessation and phase-out of discharges, emissions  and losses to water in  the long-term. This 
will usually require substitution or at least severe restrictions on use. 
Article 16 (6, 7, 8) of the WFD establishe s the obligation for the Commission to propose 
control measures at EU level to achieve th e emission objectives for PS and PHS (For the 
latter, cessation and phase-out should occur within 20 year s of the adoption of such 
measures). Measures may involve process cont rols (including emission controls for point 
sources) and product controls. However, severa l existing EU policies, for example for 
industrial chemicals, PPPs, biocides and vete rinary medicines, include mechanisms and 
criteria that can be used to a greater or lesser extent to devel op and decide on such controls to 
address the risks identified by the WFD. It wo uld not be appropriate for the Commission to 
propose alternative controls for specific subs tances on the basis of the WFD. This would 
create unnecessary double regulati on. Therefore, the options do not specify measures.  They 
assume that the other EU policies will establ ish the most appropriate controls and that 
measures might also be taken at MS level, as required by WFD Article  11(3)(k). When the 
first PS list was established, existing legislation was also seen as providing sufficient tools to 
enable appropriate measures. 
As explained in section 2.5.1, a number of the m easures that might reduce emissions to water 
of certain existing or proposed PS, such as authorisation for limited uses under REACH or  
withdrawal of an authorisati on under the biocides or PPP legisl ation, or the establishment of 
additional mitigation measures during use, ar e likely to be taken under the baseline.  
However, some might be tri ggered or accelerated as a re sult of PS designation or EQS 
revision under the WFD, or as a result of feedback from the monitoring conducted under the 
WFD – this being an obligation for the substances listed as PS.  The interaction of the WFD/EQSD with other legisl ation is explained further at the end of Annex VI.  
4.2.2.  The options A1, A2 and A3 (a)-(c) 
Option A1 is the no-policy-change option; the baseline is explained in section 2.5. The other 
options relating to substances are presented in  the table below. They are fully based on the 
outcome of the technical work presented in sections 1 and 2.2.3. They are cumulative on the 
basis of theoretically increasing impacts, star ting with existing PS, adding newly identified 
substances except pharmaceuticals, and finally adding pharmaceuticals (last because they have not hitherto been regulated under the WFD). Existing PS not included in option A2 
would not be affected. The firs t option including ne wly identified substances (option A3a) 
includes substances listed in Annex III of the EQSD, which there is an explicit legal 
obligation to review. The outcomes of the technical review of the Annex III substances are explained in the Commission Staff Worki ng Paper SEC(2011)1544 (European Commission 
2011). Effectively five (if Dioxins  and Dioxin-like PCBs are count ed as 2) of the 13 Annex 
III substances were identified by the technical process.  
Option Substance Change or 
establishment of 
EQS in water?  Biota 
EQS 
proposed? 
 Change from PS 
or identified as 
PHS? 
Anthracene Y (minor) N N 
Poly-BDE Y (significant25) Y  N Option A2: Change 
EQS and/or status of 
existing PS DEHP N N Y 
                                                 
25  If change is higher than one order of magnitude. 
 
EN 27   EN Option Substance Change or 
establishment of 
EQS in water?  Biota 
EQS 
proposed? 
 Change from PS 
or identified as 
PHS? 
Lead Y (minor) N N 
Naphthalene   Y (minor) N N 
Nickel Y (significant) N N 
PAHs    
   Benzo(a)pyrene Y (significant) 
   Benzo(b)fluoranthene Y (significant) 
   Benzo(k)fluoranthene Y (significant) 
   Indeno(1,2,3-cd)pyrene Y (significant) Y  
   Benzo(g,h,i)perylene Y (significant) N N 
Fluoranthene Y (significant) Y  N 
Trifluralin N N Y 
Dicofol Y Y Y 
PFOS Y Y Y 
Quinoxyfen Y N Y Option A3a: Existing-
PS changes plus 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 Annex 
III substances plus 
other new substances 
excluding pharmaceuticals 
Terbutryn Y N N 
17 alpha-ethinylestradiol Y N N 
17 beta-estradiol  Y N N Option A3c: Existing-
PS changes plus Annex 
III substances plus 
other new substances including 
pharmaceuticals Diclofenac Y N N 
Details of the proposed EQS are provided in Annex II. 
4.3. Policy options in relation to the specific difficulties with ubiquitous PBTs 
There are three sub-problems under this head ing, with their own obj ectives. Options have 
been structured as follows: 
Option Presentation Choice of  matrix Monitoring effort 
B1 No change (presentation of all PS 
results together) No change (choice is fully free)  No change (minimum frequency but 
some flexibility if technically 
justified) 
B2a Allow separate presentation of 
ubiquitous PBTs   
B2b Take ubiquitous PBTs out of 
chemical status   
B3a  Conditioned to meeting or coming 
closest to the minimum performance 
criteria of Commission Directive 
2009/90/EC  
B3b  Fixed choice for each substance  
B4a   Introduce reduced monitoring 
obligations for ubiquitous PBTs if 
certain specified conditions are met 
B4b   Introduce reduced monitoring 
obligations for ubiquitous PBTs 
 
EN 28   EN (unconditional) 
  
The issues and options are largely independent and therefore any combination of options (one 
per sub-problem or column) is possible. The following substances have been identified as 
ubiquitous PBTs: BDEs, Mercury, Tributyltin (TBT), PAHs (existing PS) and Dioxins/DL-
PCBs; Heptachlor and heptachlor epoxide , HBCDD, PFOS (possible new PS). 
4.3.1.  Option B1: No change 
This option would mean continuing as now.  The baseline is expl ained in section 2.5. 
4.3.2.  Option B2a presentation: Allow separate  presentation of ubiquitous PBTs  
This option identifies a number of substances th at are ubiquitous PBTs at EU level and allows 
MS to present the assessment for some or all of  these substances separa tely (e.g. in separate 
maps) from that for the rest of the PS in th e RBMPs, although the chemical and overall status 
assessment would still need to include them. 
4.3.3.  Option B2b presentation: Take ubiquitous PBTs out of chemical status 
This option would mean that the assessment of  chemical status would no longer need to 
include the levels of these s ubstances, good chemical status could be met on the basis of 
meeting the obligations only for the other PS. This would mean taking the substances out of 
WFD Annex X and EQSD Annex I. There would not be a legally binding EU-wide EQS.  
The obligation to monitor and report according to EQSD Article 3.3 would be kept in order to 
ensure that there were at least a trend assessmen t of the concentrations of these chemicals. No 
other legislative tool provides for their monito ring in the aquatic environment at EU level. 
4.3.4.  Option B3a choice of matrix: Leave flexibility  but link the choice to requirements of 
Directive 2009/90/EC 
A preferred matrix/matrices for monitoring and compliance checking for each substance 
would be identified (as it is one of the outcomes of the technical process)26. The choice of 
matrix would still be left to the MS except in cases where  
• the available analytical technique fulfils  the performance crit eria of Directive 
2009/90/EC in one matrix and not in the other(s), or  
• no analytical technique meet s the performance criteria but the technique for one 
matrix performs significantly better than  that for the other matrix/matrices,  
and there is an EQS available at EU level for at  least the matrix where the analytical technique 
performs according to the criter ia in Directive 2009/90/EC or pe rforms better than  in the other 
matrix/matrices. In this case MS would have to use the matrix for which Directive 
2009/90/EC is fulfilled or for which the analytic al technique performs significantly better in 
relation to the criteria in Directive 2009/90/EC. 
                                                 
26  As explained in the problem de finition section, options B3a and B3 b are most obviously relevant to 
ubiquitous PBTs but would apply to all PS. 
 
EN 29   EN A common example would be the case of a hydrophobic and bioaccumulative substance 
where the EQS in water is very low and an EQS for biota has been derived. The best available 
analytical technique for water does not fulfil the requirements of Directive 2009/90/EC, but it 
does for biota. In that case, MS would have to use the biota standard. 
The assessment of the relative perf ormance of the analy tical methods would be left to the MS, 
possibly with some technical guidance to be deve loped at EU level, if needed to complement 
the criteria given in Commission Directive 2009/90/EC. 
4.3.5.  Option B3b choice of matrix: Fix the pr eferred matrix for each substance 
The choice of matrix for monitoring and comp liance checking would be fixed at EU level for 
each substance, reflecting the outcome of the expert work (see Annex II).  
4.3.6.  Option B4a monitoring: Introduce reduced  monitoring obligations for ubiquitous 
PBTs if certain specified  conditions are met 
Criteria for reducing the monitoring effort for the substances identified as ubiquitous PBTs 
would be established in the legislation, i.e. cr iteria for applying the flexibilities in the WFD 
and EQSD as regards monitori ng frequencies (based on "tec hnical knowledge and expert 
judgement") and for reducing the number of site s at which the ubiquitous PBTs need to be 
monitored.  This reduced monitoring effort c ould apply without further justification only if 
there were enough information on the presence of the substance in water bodies (in particular 
in sediment and/or biota), i.e. there were a robust baseline of monitoring information. This 
reduced monitoring would be without prejudic e to the need to undertake more detailed 
monitoring if local measures had to be taken an d their effectiveness had then to be assessed.  
4.3.7.  Option B4b monitoring: Introduce reduced  monitoring obligations for ubiquitous 
PBTs (unconditional) 
Allow reduced monitoring (frequency and number  of sites) for ubiquitous PBTs compared 
with the general requirements for other PS. In this option the reduced monitoring effort could 
be applied without preconditions. 
4.4. Policy options in relation to improving the knowledge base 
4.4.1.  Option C1: No change 
This option would mean continuing as now.  The baseline is expl ained in section 2.5. 
4.4.2.  Options C2 and C3: Establishment of a watch list 
These options would involve esta blishing a watch list.  The aim would be to en sure targeted 
monitoring across the EU of substances of possible con cern, for example, emerging 
pollutants, to provide a database of high-quality information fit for the purpose of subsequent prioritisation exercises under th e WFD.  Two approaches woul d be possible, a watch list 
without a legal obligation, or a watch list with a legal obligati on.  The list would be 
"dynamic" with substances being regularly added and removed. Approximately 20 would be 
on the list at any one time, monitored by MS at 250-300 representative sites across the EU 
according to agreed technical guidelines for monitoring (site selection, sampling and 
analysis), with results being reported to the Water Information System for Europe (WISE). 
 
EN 30   EN The technical details including the structures that would be involved in supporting the 
operation of the watch list are described in Annex III.  
4.4.3.  Option C2: Establish a watch list without legal obligation 
This option would entail establishing a watch list on the basis of a voluntary system of 
monitoring and reporting. The well-established in formal decision-making process of the CIS 
would be used. This has been operating well  since 2001 and involves decision making by the 
WFD Water Directors, hence ensu ring political suppor t in the MS. The t echnical proposals on 
the selection of substances to monitor and th e guidelines for monito ring would be forwarded 
to the Water Directors for endorsement at  one of their twi ce-yearly meetings. 
4.4.4.  Option C3: Establish a watch list with legal obligation 
This option would entail estab lishing a watch list through a le gally binding instrument. This 
would involve a legal provision that establishes the watch li st in generic terms in the 
legislation, with the obligation for MS to monitor and report to the Commission, and a 
mandate for the Commission to develop the list of substances. The list would be adopted by 
Commission Decision. 
The structures involved in the technical work and data collection would be the same as in 
option C2, including the use of the CIS WGE/ CMEP groups and the WISE reporting system. 
The technical guidelines for the monitoring pr ocess would still be developed informally. 
There is considerable experience in the CIS of  developing informal guidance for endorsement 
by the Water Directors. This procedure reduces significantly the administrative burden but has 
proven efficient with high rates of uptake of the guidelines by the MS. 
Alternative options to formally  adopt the technical guidelines for the monitoring would entail 
a heavier and longer administrativ e procedure that would, because  of the need for substance-
specific updates, reduce the usefulness of the wa tch list, limiting the frequency of renewal and 
thus its effectiveness at meeting the objectiv e of “improving the knowledge base”. Formal 
adoption of technical guidelines would also no t be consistent with what the Commission and 
the MS have been doing over th e past 10 years for the implementation of the WFD and the 
related Directives (Floods, Groundwater, EQSD),  a system that is highly appreciated as 
effective and not entailing excessive administ rative costs (see for example conclusions of 
Water Directors meeting of December  2008 and CIS Work Programme 2010-201227).  
In the consultation phase it was a consensus vi ew of the MS that the development of the 
technical work should be done using existing structures.  
5. ANALYSIS OF IMPACTS AND COMPARISON OF THE OPTIONS  
5.1. Introduction 
The different sets of options (A, B and C) a ddress different problems and are of a different 
nature. For this reason, this section sets out th e analysis of impacts for the options in set A, 
                                                 
27 
http://circa.europa.eu/Public/irc/en v/wfd/library?l=/framework_direc tive/implementation_documents/fi
nal_2010-2012/_EN_1.0_&a=d   
 
EN 31   EN then a comparison of those options; then does th e same for the options in sets B and C. The 
criteria for comparison of the options have been  adapted to the nature of the options. In all 
cases, an assessment has been made as regard s effectiveness at reaching the general and 
specific objectives set out in section 3. The opti ons are compared relative to the "no-change" 
options A1, B1 and C1; the baseli ne is explained in section 2.5. 
5.2. Analysis of impacts of the substance options 
5.2.1.  General considerations as regards cost s and benefits of the substance options 
Annex IV includes a summary of the appr oach used to assess the impacts. 
Although specific measures are not proposed in th e options at either EU  or MS level, as 
explained in section 4.2.1, considerable efforts were made to obtain quantitative information 
regarding the impacts of poten tial measures.  However, little quantitative information was 
received for many of the substances, even on the potential economic costs (see section 5.2.2). 
In view of this and of the uncertainty regardin g the measures that might be applied, a largely 
qualitative approach was taken in the analysis. This appears proportionate c onsidering the 
limited direct effects of the pr oposed options, the fact  that the decision processes regarding 
action under other sectoral EU legislation usua lly include a socio-economic analysis, and the 
fact that MS can apply exemptions regardi ng attainment of the environmental objectives 
under the WFD (see section 5.2.1.2). 
Nevertheless, to the extent po ssible, information on the scale of the benefits and costs is 
presented under the various options. 
It should be borne in mind that the Treaty  establishes as one of  the pillars of EU 
environmental policy the control of pollution at source. This principle gives priority to 
upstream controls on the assumption that, in gene ral, rectification at source is more cost-
effective than end-of-pipe solutions. The impor tance of considering upstream measures was 
highlighted by MS and stakeholders during the c onsultation; they also stressed the need to 
consider the feasibility of phasing out certain su bstances that are currently in use and others 
that are produced unintentionally. 
5.2.1.1.  Benefits 
This section presents quantitative and qualitative information on the main generic benefits 
expected from the substance options A2 to A3c. The magnitude would depend on the 
ambition of the options. Positive impacts specific to the proposals for individual substances are presented in later parts of  section 5.2 on the specific impact s of the individual substance 
options. 
Since the options do not specify measures, th e assessment of the pot ential benefits of 
measures themselves (as compared with the be nefits of monitoring) can only be based on the 
potential measures that might be taken at EU or MS level as a result of the proposal. 
Realisation of some of the benefits would be in the long-term. Benefits to health are extremely difficult to quantify, being dependent  on many factors in addition to exposure and 
intrinsic hazard. 
Environmental benefits
 
 
EN 32   EN • Regular monitoring and consequently incr eased knowledge of the extent of water 
pollution, particularly valuable to assess the effectiveness of the measures taken under the 
WFD and other sectoral legislation to limit the emissions; this benefit would not be 
achieved under the other sectoral  legislation alone. It should be noted that monitoring of 
the substances in option A2 already occurs, and that EQS for them already exist, but that changes in the EQS matrix for some of those substances would be expected to improve the 
quality of the monitoring data. 
• The triggering of measures, in cluding by feedback from m onitoring, to limit chemical 
emissions, with consequent improv ements in biodiversity that will  result in a more resilient 
aquatic ecosystem, enhancing its capacity to deliver ecosystem services such as the 
processing of excess nutrients (Cardinale 2011). Recent studies from the JRC have 
estimated the monetary value of the remova l of nitrogen performed naturally by healthy 
river ecosystems in the EU as being of the order of 373 million € per year (JRC, 2011).  
• Wider benefits to biodiversity, i.e. beyond the immediate aquatic ecosystem, in view of the 
extensive interactions between different eco systems and organisms, including through 
migration. 
• Cleaner sediments (including as  a result of remediation informed by monitoring) meaning 
less potential for re-dissolution in the wate r column and reduced uptake of harmful 
substances by plants and animals. 
Economic benefits
 
• Moving towards a level playing-field for industr y across the EU as regards the driver for 
the authorisation of discharges, compared to the current situation where MS establish their 
own EQS for some of the candidate PS. Na tional EQS for some substances differ by 
several orders of magnitude (e.g. 2 orders of magnitude in the case of Dichlorvos, 3 orders 
of magnitude in the case of Heptachlor, one or der of magnitude in the case of Terbutryn). 
• Reduced treatment costs for drinking water and industrial process water.  E.g. in the context 
of the 2006 impact assessment, based on data from 3 MS, estimated unit costs for removal 
of pesticides were 0.028 €/m3 (Ecolas, 2005) . Based on data from BE, DE, NL and UK, 
that study estimated that 74% of surface waters used for th e production of drinking water 
exceeded regularly the standard of 0.1 μg/l. Latest data from EUREAU suggest that the 
value of 74% is probably overestimating the pe rcentage of water bodies that show regular 
exceedances, but in any case the costs are considerable. According to Eurostat (2011, env_watq2_1), around 20 900 million cubic metres of surface water are abstracted in the 
EU for drinking water production. Using th ese figures, the following table presents 
estimated annual costs of treatment for three different scenarios: 
Percentage of surface water bodies used for the abstraction of drinking water 
that exceed regularly the standard for pesticides 30% 50% 70% 
Estimated treatment cost (million € per year) 175 292 409 
• Cleaner sediment implying cheaper mana gement of waste from dredging. Around 200 
million cubic metres of sediment are dredged every year in the EU (SedNet, 2004). Management costs are heavily dependent on the sediment quality and vary from 1 to 45 
€/m
3. Assuming that 10% of the material is contaminated (value from the Port of 
 
EN 33   EN Rotterdam) and hence requires hi gher disposal costs in th e range of 10 to 30 €/m3, the 
annual expenditure in handling contaminated dre dged material is in th e order of 200 to 600 
million € per year. The potential cost savings in the long term are therefore significant. 
• The potential for healthier, more productiv e commercial fisheries and aquaculture. 
• Fostering of innovation to find substitutes for PHS. 
Social and public health benefits  
• More information for the public on th e quality of the aquatic environment; 
• Reduced bioaccumulation of many hazardous chemicals in humans, reduced exposure 
(occupational and other) if less hazardous substitutes are used; 
• Potential improvements in quality of fish and shellfish from commercial fisheries, 
aquaculture and recreational fishing. 
• Improved amenity value of water bodies (tour ism, angling, etc), and reduced exposure for 
humans using them for bathing, surfing and other water sports; 
• Cleaner water for livestock where surface wate r is used directly, resulting in reduced 
accumulation in meat and milk, hence reduced human exposure to hazardous substances, 
likewise, less accumulation in meat from game drinking surface waters directly; 
• Reduced potential for accumulation of hazardous substances in crops when untreated 
surface water is used for irrigation. 
5.2.1.2.  Costs 
The most important costs fall into the " economic" category. If significant social or 
environmental costs (beyond water) are involved  they are mentioned in later sections. 
The obligation to monitor PS means that additi onal monitoring costs would apply to all the 
substance options except option A2 which relates only to existing PS. These were estimated on the basis of figures provided by MS for the existing PS (see Annex IV), and are given in 
the relevant sections.  The Standard Cost Mode l was not used for these estimates because of 
the availability of data from the MS, which allowed the analysis to be tailored more 
realistically. 
Since the options do not specify measures, the a ssessment of the other potential costs of the 
options can only be based on potenti al measures that might be ta ken at EU or MS level as a 
result of the proposal.   
The substances proposed as PHS, with the exception of Quinoxyfen, are already regulated 
under other sectoral EU legislati on, and in some cases subject to  (or likely to become subject 
to) international conventions, in ways that should eventually achieve the cessation or phase-
out of emissions, subject to the availability of substitutes where needed.  Therefore their 
designation as PHS is not expected to lead to any significant impacts on the market (both in 
terms of users and producer s) beyond the baseline.  
 
EN 34   EN For the other substances proposed for addition to the PS list or a more stringent EQS, 
measures beyond the baseline might be taken u nder the other EU legislation, but these and 
their costs cannot be predicted. However, the chemicals (REACH), biocides and PPP 
legislation contains provisions  for authorisation decisions to  take account of socio-economic 
(including environmental) factors.  Where measures are taken at MS level, it is important to 
note that, although PS are selected from among those posing a risk at EU level, local pollution 
and circumstances can vary substantially and with them the costs of the measures. For 
example, the treatment required at an Urban Waste Water Treatment Plant (UWWTP) will be 
determined by the characteristics of the receiv ing water body, its uses and other discharges. It 
should be noted that the major ity of UWWTPs provide only "sim ple treatment", but that MS 
are already obliged to upgrade cer tain plants to secondary treat ment according to Article 4 of 
the Urban Waste Water Treatment Directive a nd that the cost of doing this cannot be 
attributed to the options in this IA. 
In this context it is also important to note that , if the relevant conditions are fulfilled (on the 
basis of local assessment), MS may rely on certai n exemptions, i.e. if measures to achieve the 
WFD objectives are tec hnically unfeasible, disproportionate ly expensive, or would take 
longer than the WFD deadlines due to natural processes, or if the origin of the problem is 
transboundary, exemptions under WFD Article 4(4) (extension of deadlines) and 4(5) 
(lowering of objectives) may be us ed for specific water bodies if all conditions listed in those 
Articles are fulfilled. This provides MS with a lega l safety net to deal w ith specific situations 
in which the costs of achieving the environmen tal objectives would significantly exceed the 
benefits – it is for MS to carry out this assessment. Guidance on ap plying exemptions is 
available28. Although exemptions relate to WFD envi ronmental objectives and thus to the 
obligations on MS, they can potenti ally indirectly apply to emi ssions by individual operators. 
Whether MS would be able to take the ope rators' position into acc ount would depend upon 
the justification provided, since the overall exem ption would have to be justified to the public. 
As indicated in section 5.2.1, little quantita tive information was received for many of the 
substances. It seemed inappropriate to attempt a quantitative analysis combining those data with the uncertain policy outcomes, beari ng in mind the other poi nts above. A largely 
qualitative approach was therefore taken to assessing the costs of the options, except in 
relation to the monitoring obligation. 
The additional monitoring costs would be borne by MS. On the basis of the information obtained, th e impacts on EU companies (see the following 
sections and especially section 5.7) would be expected to be re latively small and not to affect 
the competitiveness of individual MS or overall EU competitiveness. As indicated in section 
2.6, the setting of EQS at EU leve l should create a more level pl aying field for the MS than 
when only a few MS set an EQS or the nationa l EQS are very different. As stated above, 
exemptions applied by MS could indirectly appl y to companies and thus keep costs within 
proportionate limits. Other reasons for not ex pecting impacts on competitiveness are that 
relatively few substances are involved compared with th e total number on the market; 
substitution is not seen as a likely requirement (beyond th e baseline) for most of the 
substances in the options, either because they are already heavily regulat ed and will have to 
be substituted anyway or because they are not designated as PHS and their use will generally 
be able to continue; most of the producers i nvolved are large (even multinational) and have an 
                                                
 
28 European Commission, 2009b 
 
EN 35   EN extensive product portfolio; subs titutes generally exist where necessary (further information 
appears under the individual opti ons below), and the need for measures to control emissions 
to the aquatic environment from many of the substances is also ac knowledged in other parts 
of the world, e.g. in at least Australia29, Canada (see footnote 15) and the USA30 regarding 
Cypermethrin, in at least th e USA regarding pharmaceuticals31 (although no standards have so 
far been set), worldwide regarding the de signated POPs. Although  Quinoxyfen use is 
currently still authorised in Au stralia, the instructions for use are strong on the need to avoid 
any emissions to water.  
Additional costs to producers co uld include: the cost  of (further) reducing point-source 
emissions at a production site, temporary loss of overall sales volume while shifting to a 
substitute product, the cost of investing in th e development and production of a substitute.   
Costs to users/consumers would also be expected  to be relatively small, consisting of the 
possible additional cost of substitute products, or an increase in the cost of water if water 
companies pass on the - proportionate - costs of a dditional treatment, or of cleaner energy.   
Small and medium-sized enterprises (SMEs) that might be affected by the options include 
pesticide and coating formulators, textiles a nd plastics companies, construction companies, 
dockyards, ship owners, fish ermen, arable and salmon farmers, pharmacies, waste 
management companies, and water companies.  However, with the exception of the water 
companies, as explained further in the contex t of options A2 and A3c, they would not be 
expected to face significant costs beyond the base line. As noted above in the context of EU 
companies generally, substitution is not seen as a likely requirement for most of the substances, and where it is, it would in most cases be required in the baseline, and subject to 
the availability of substitutes. Impacts on SM Es relevant to the individual substances are 
mentioned under the options below. 
5.2.2.  Uncertainties in the analysis of the substance options 
Uncertainties in the analysis of the benefits and costs of the substance options derive from: 
• Uncertainties in the exceedance of the propos ed EQS in each MS, especially where the 
prioritisation was based primarily on modelling; 
• Uncertainties in the baseline measures; 
• Uncertainties in the measures that would be  taken to meet the EQ S and, if applicable, 
phase-out requirements; 
• Incomplete production and use data, e.g. production volume and location, associated 
employment; use in some MS; 
• Limited estimates, if any, of the costs of reducing emissions from industrial point 
sources and of removing pollutants at UWWTPs; 
• Relative paucity of data rega rding the cost and possible impacts of substitutes, where 
relevant; 
                                                
 
29  http://www.apvma.gov.au/products/review/docs/ sheep_ectoparsiticide_prelim_report_vol_2.pdf   
30 
http://www.swrcb.ca.gov/rwqcb5/wate r_issues/tmdl/central_valley_projects/central_valley_pesticides/c
riteria_method/cypermethrin/2011mar_cypermethrin_draft.pdf   
31  http://water.epa.gov/scitech/swguidance/ppcp/index.cfm   
 
EN 36   EN • Difficulty in attributing benefits to action on particular substances and in quantifying 
them.  
Not all the uncertainties apply to all the substances, or to the same extent.  Notable substance-
specific uncertainties are given in the tables in the sections  that follow, and/or in the 
factsheets in Annex V. 
The uncertainties exist despite the substantial effort that went into compiling the monitoring 
database used for the prioritisation, and desp ite the comprehensive consultation carried out 
(see section 1.4) to gather th e necessary data and informa tion to underpin the analysis. 
During the consultation, MS and st akeholders in WG E stressed that unrealistic extrapolations 
and attempts at quantitative estimates should not be done.  This view was expressed in 
relation to, among other aspects, estimating the baseline concentrations where monitoring data 
were not available, and the supporting study di d not pursue an early proposal to calculate 
concentrations on the basis of surface water vol umes to quantify the possible exceedance of 
the proposed EQS in "missing" MS. The appro ach of using case st udies to support the 
assessment of impacts (see Annex IV) was designed to some extent to overcome this. 
Still, a few stakeholders considered that the ex tent of the monitoring da ta for some substances 
(Cypermethrin, EE2, Quinoxyfen) did not justify prioritisation. For Cype rmethrin, 3 out of 5 
MS in the database showed exceedances of the EQS, and many additional samples below the determination limit in those and other MS ma y also have been above the EQS. Although 
sheep dipping used to be one of the main uses  of Cypermethrin in the UK (the MS showing 
the greatest number of exceedances), this should  no longer be the ca se, but no data are 
available showing that exceedances don't still occur from other uses. Cypermethrin was 
ranked high in the modelling as well as the mon itoring-based prioritisati on.  For EE2, the data 
for 3 countries in the monitoring database were  complemented by literature data.  Quinoxyfen 
was reviewed because of its EQSD Annex III status, and although only 2 MS provided 
monitoring data (most from FR, showing isolated exceedances),  this PPP is authorised in 17 
MS and is a PBT. Further explanation regarding the m onitoring and modelling-based 
prioritisation processes is provided in the Commission Staff Working Paper SEC(2011)1544 
(European Commission 2011).  
Although the starting point for c onsultation was the membership of WG E, therefore mainly 
stakeholder groups, several individual compan ies were contacted al so directly by the 
Commission and/or Entec. Indeed, for a number of the substances included in the options, 
individual companies participated in the WG  E and Sub-Group meeti ngs and provided some 
input directly to the technical work on EQS de rivation. However, despite repeated requests for 
information for the substance impacts report s, and consultation on them, the amount and 
quality of data and information received from MS and stakeholders was limited.  
5.2.3.  Analysis of impacts of Option A2: C hange EQS and/or status of existing PS 
The impacts of this option over and above the ba seline include those a ssociated with changes 
to (i) the EQS (ii) the monitoring matrix an d (iii) the status of the substances. Specific 
analysis for each substance is presented later in this section. 
5.2.3.1.  Change in the EQS  
Impacts could result from the potential need to take measures to meet a more stringent EQS 
for some of the PS.  The measures require d and the sectors involved would depend on the 
 
EN 37   EN substance.  The costs would de pend on the type of measure a nd on the scale of action, which 
would depend upon the extent of EQS exceedance.   
5.2.3.2.  Change in the EQS matrix  
Biota monitoring is more expensive per sample /analysis, but fewer sampling locations are 
needed and a lower frequency (annual according to EQSD Art 3(2)(c), cf. monthly according 
to WFD Annex V) due to the in tegrative character of biota. The impact of this option on 
monitoring costs is therefore estimated to be ne utral, although there w ould be some adaptation 
costs for MS which have not previously monitore d routinely in biota. Cu rrently the choice of 
matrix is left to MS and therefore it is not appr opriate to attribute such adaptation costs to this 
option.   
As regards benefits, establishing a biota standard at EU level for the substances for which it is 
the most appropriate matrix due to their pe rsistence and bioaccumulation potential would 
encourage MS to monitor in biota, improve know ledge of the extent of the problem (including 
the possible need for sediment remediation), and allow better evaluation of the effectiveness 
of measures, thereby providing a better basis for improved protection. The encouragement for 
MS to monitor in the most su itable matrix, would come from: their no longer needing to 
develop their own standard, for which many l ack the expertise. Differences between MS 
would also be reduced (a preliminary assessmen t of national EQS in 14 MS shows that the 
national EQS for 35 substances differ by at leas t 2 orders of magnitude between the country 
with the lowest and the highest EQS). 
5.2.3.3.  Change in status 
The impacts of this change would be in relation to the stricter regulation that applies to PHS 
cf. PS, i.e.  the need to cease discharges, emissions and losses of the substance to water within 
20 years of the adoption of the releva nt measures at Community level. 
5.2.3.4.  Summary of specific impacts per substance 
The table below summarises the sp ecific impacts per substance. More details are provided in 
the factsheets in Annex V. Monitoring of these substances is in the baseline, but the information obtained on Fluoranthene, PAHs a nd PolyBDEs would be expected to improve 
with the expected shift from  water to biota monitoring. 
# Substance 
(main uses) Baseline* and proposed 
change Summary of significant 
specific impacts Remarks re substitution, 
SMEs, notable uncertainties 
2 Anthracene 
 
(Main use as component of 
coal tar pitch; some use in pure form in pyrotechnics.  
Produced during 
combustion, therefore many 
sources, including metal 
industry.) PHS; 
possible inclusion in 
REACH Annex XIV; 
IED, waste legislation; POPs Regulation – could 
all reduce emissions. 
 
Change: MAC-EQS Positive:  Improved 
coherence with chemical 
policy, i.e. with the 
outcomes of the risk assessment under 
Regulation (EC) No 
793/93. Greater attention 
to reducing point source 
emissions due to more 
stringent MAC-EQS.  
Negative:  No significant 
negative impacts 
expected as change is not 
major.  Emissions (partly natural) 
cannot be completely 
eliminated. 
Local negative impacts on SMEs cannot be discounted 
but unlikely to be significant 
given small magnitude of 
change; no information 
provided by stakeholders. 
Uncertainty re authorisation; 
extent of failure of current 
MAC.  
5 Poly-BDE 
 
(Main use as flame 
retardants in polymers and PHS; 
POPs (4 congeners); 
REACH; IED; waste 
legislation (new limits Positive: Encouragement 
to MS to monitor in biota 
instead of monitoring 
(ineffectively) in water, Most impacts in baseline. 
Substitutes exist. 
As regards SMEs: Possible 
local impacts on water 
 
EN 38   EN textiles; only deca BDE still 
authorised, and no longer in 
electrical/electronic 
products.)   proposed); possible 
inclusion of penta and 
octa BDEs in Rotterdam 
Convention – could all 
reduce emissions. 
 
Change: EQS, matrix therefore better 
information for improved 
protection (see section 
5.2.3.2).. 
Negative: Widespread 
presence makes it very 
difficult to reduce further 
the emissions, discharges 
and losses.  Potential 
local impacts, including 
if sediment remediation is 
needed. companies and landfill 
operators. 
Uncertainties re extent of EQS 
failure in MS due to 
inadequate analytical 
sensitivity; inclusion in 
Rotterdam Convention; effect 
of more stringent EQS on 
decaBDE use (and import).  
12DEHP 
 
(Main use as plasticiser in 
polymers, especially PVC, 
including in construction 
products and medical 
equipment.) PS; 
included in REACH 
Annex XIV, sunset 2015 
(substitution in baseline); 
IED; waste le gislation – 
could all reduce 
emissions32. 
 
Change: Status Positive:  Coherence with 
REACH; particular 
consideration under 
REACH authorisation 
process of uses affecting 
aquatic environment. 
Negative: Classification 
as PHS not likely to have 
impacts beyond baseline 
as regards production and 
use. Widespread presence 
in existing construction 
materials makes it 
difficult to reduce further 
the discharges, emissions 
and losses.  However, 
there might be local 
impacts if measures were 
taken at MS level. Most impacts in baseline. 
Substitutes exist, but 
incomplete info on 
environmental and health 
impacts 
As regards SMEs: Possible 
impact on water companies (if 
required to increase removal 
rate of DEHP). 
Uncertainty re outcome of 
authorisation process under 
REACH. 
20Lead 
 
(Main use in batteries, 
accumulators, shot, ship 
keels, construction 
materials etc.)  PS: 
REACH (Evaluation of Registration dossier); 
IED; waste le gislation – 
have potential to reduce 
emissions. 
 
Change: EQS Positive:  Alignment of 
EQS with latest science; use of a "bioavailable" 
EQS and monitoring of 
bioavailable Lead would 
provide better data, 
possibly useful to target 
remediation.  
Negative:  Change to 
EQS not major 
(equivalent to a change 
from 7.2 to 6 μg/l total 
Lead, ), therefore no 
significant impact 
expected.  Most impacts in baseline. 
Uncertainty re extent of failure of EQS in MS in absence of 
data on DOC. Local impacts, 
especially in areas with low 
DOC, cannot be discounted 
but no information provided 
by MS or stakeholders and not 
possible to estimate, though 
would be minor given small 
magnitude of change. 
22Naphthalene 
 
(Main use as chemical 
intermediate, produced 
from coal tar pitch.  
Produced during 
combustion, therefore many 
sources, including metal 
industry.)  PS; 
REACH (including 
possible addition of coal 
tar pitch high temperature 
to Annex XIV); IED; 
waste legislation; POPs 
Regulation – could all 
reduce emissions. 
 
Change: MAC-EQS Positive:  Improved 
coherence with chemical 
policy. Possibly greater 
attention to reducing 
point source emissions 
due to introduction of 
MAC-EQS.  
Negative:  No important 
impact expected as 
change of Annual 
Average EQS (AA-EQS) 
is not major and MAC-
EQS is two orders of Emissions (partly natural) 
cannot be completely 
eliminated. 
Local negative impacts on 
SMEs cannot be discounted 
but no information provided 
by stakeholders and not 
possible to estimate. 
Uncertainty re authorisation, 
and re failure of proposed 
MAC.  
                                                 
32  Since this impact assessment was drafted, a proposal has also been tabled by Denmark to place 
restrictions (under Annex XVII of REACH) on the placing on the market and use of certain articles containing DEHP and three other phthalates  
 http://echa.europa.eu/documents/10162/17096/information_note_dk4phthalates_en.pdf
 
 
 
EN 39   EN magnitude higher than 
AA-EQS. 
23Nickel 
 
(Main use in alloys, metal 
plating, batteries, steel 
manufacture.) PS; 
REACH (Evaluation of 
Registration dossier); 
IED; waste le gislation – 
have potential to reduce 
emissions. 
 
Change: EQS Positive:  Alignment of 
EQS with the latest 
science available. 
Reduced risk to or via the 
aquatic environment. 
Monitoring of 
bioavailable Nickel 
would provide better 
data. Negative:  Significant 
tightening of the standard 
would lead to increased 
failure of EQS across EU, 
but variable among MS, 
driving upgrades in water 
treatment. (See text for 
details ) Local impacts possible on 
industrial SMEs and water 
companies. Costs to water 
companies/authorities and 
industry likely to be passed to 
consumers, directly or 
indirectly, within 
proportionate limits. 
Assessment uncertain due to lack of monitoring datasets 
that contain the necessary data 
for calculation of 
bioavailability and lack of 
information on natural 
background concentrations.  
28PAHs 
 
(Main use as component of 
coal tar pitch.  Produced 
during combustion, 
therefore many sources, 
including metal industry.) 
 
 Benzo(a)pyrene 
 Benzo(b)fluoranthene 
 Benzo(k)fluoranthene 
 Indeno(1,2,3-cd)pyrene 
 Benzo(g,h,i)perylene PHS; 
REACH (including 
possible addition of coal 
tar pitch high temperature 
to Annex XIV); IED; 
waste legislation; POPs 
Regulation  - could all 
reduce emissions. 
 
Change: EQS and matrix 
for 4; MAC-EQS for 
Benzo(g,h,i)perylene Positive: Improved 
coherence with chemical 
policy. Possibly greater 
attention to reducing 
point source emissions of 
some PAHs due to 
introduction of  MAC-
EQS. Biota standard 
would allow better 
assessment of the extent 
of the problem and of the 
effectiveness of 
measures. 
Negative:  Dependent 
upon whether additional 
measures needed. 
 Emissions (partly natural) 
cannot be completely 
eliminated. 
Local negative impacts on 
SMEs cannot be discounted 
but no information provided 
by stakeholders and not 
possible to estimate. 
Uncertainty re authorisation of 
coal tar pitch and extent of 
failure of proposed EQS and 
MAC. 
15Fluoranthene 
 
(Main use as component of 
coal tar pitch.  Not 
produced or used in pure 
form. Produced during 
combustion, therefore many 
sources, including metal 
industry.)  PS; 
REACH (including 
possible addition of coal 
tar pitch high temperature 
to Annex XIV); IED; 
waste legislation; POPs 
Regulation – could all 
reduce emissions. 
 
Change: EQS Positive: Improved 
coherence with chemical 
policy. Biota standard 
would allow better 
assessment of the extent 
of the problem and of the 
effectiveness of measures 
. 
Negative: Shift to biota 
standard likely to result 
in a significant increase 
in failures. Potential local 
impacts if sediment 
remediation is needed. Emissions (partly natural) 
cannot be completely 
eliminated. 
Local negative impacts on 
SMEs cannot be discounted 
but no information provided 
by stakeholders and not 
possible to estimate. 
Uncertainty re authorisation of 
coal tar pitch; extent of failure 
of current EQS.  
33Trifluralin 
 
(Use as herbicide no longer 
authorised.) PS; 
Recommended POP; 
PPP legislation (recently 
excluded from Annex I of 
Dir 91/414/EEC) – 
emissions should be 
declining. 
 
Change: Status Positive: Change of 
status would ensure 
coherence with latest 
scientific information and 
PPP policy. 
Negative:  No significant 
negative  impact expected 
as non-authorisation is 
already in the baseline.  Uncertainty re possible need 
for local remediation and re 
outcome of POPs negotiations. 
No negative impacts on SMEs 
expected, except possibly  in 
the short term for producer in 
Hungary if production has to 
stop;  POP designation likely 
in baseline anyway. 
* WFD Programmes of Measures relevant in all cases; uncertain  impacts. See Annex V for in formation on other relevant 
legislation in baseline.  
The main positive and negative impacts of this op tion are summarised in the table in section 
5.3.  
 
EN 40   EN The setting of a more stringent EQS for Nickel (2 μg/l bioavailable, corresponding to around 
5.6 μg/l total dissolved, cf 20 μg/l total dissolved) would be like ly to drive lo cal upgrades of 
industrial and/or urban WWTPs, and better control of indus trial discharges into urban sewer 
systems. The need would have to be assessed at local level, as th e impact would depend on 
local conditions (nickel bioavailability a nd hence toxicity depends on environmental 
conditions such as pH, dissolved organic carbon and hardness, dilution of the discharges in 
the receiving water body, interactions with other di scharges in the basin, etc). Application of a 
biotic ligand model (a tool to determine bioa vailability on the basis of the environmental 
conditions) to available monitoring data show s potential significan t failures in some 
countries: BE (4 to 56% of samples), DE (6 to 52%), IT (18 to 72%), RO  (6 to 27%), SI (0.3 
to 8%), the range depending upon the effect on bioavailable Ni ckel concentrat ions of the 
combination of environmental conditions . Data sets containing the necessary information to 
calculate bioavailability show negligible imp act in SE, significant in the UK (9 to 26%). 
Estimates for the UK indicate that approximately  2% of the UWWTPs might need upgrading, 
requiring whole-life investment of the order of  2 billion € and attenda nt additional running 
costs. This is considered to be a worst case as the ambient concentrations of Nickel in the UK 
are among the highest in the EU. The estimate is based  on a EQS bioavailable  of 2 μg l-1, and 
would be lower if an EQS of 4 μg l-1 were adopted as proposed by the industry stakeholder. 
This higher EQS could only be arrived at if it  were accepted that the field data provided by 
the industry removed any uncertainty about the lowest no effect concentration derived in 
lower-tier studies, a position not agreed upon by the Sub-Gr oup on PS as a whole. The 
importance of considering bioavailability and natural background concentr ations was stressed 
by MS and stakeholders during consultation. Industry provided estimates suggesting that the 
number of industry installations that w ould fail to comply with an EQS of 2 μg l-1 would be 
significantly greater, depending upon the sector, th an the number failing to comply with an 
EQS of 4 μg l-1. For example, in 12 out of 16 sector s, no sites would be compliant at 2 μg l-1, 
whereas at 4 μg l-1 only 3 sectors would be non-compliant at  all sites. However, the estimates 
were not based on a full consideration of bioava ilability and appear to represent a worst-case 
scenario. 
Otherwise in this substance option, no significant  costs would be expected for EU industry or 
for MS, as changes compared to the baseline ar e relatively minor. As in the case of some 
other substances, the outcome of the REACH au thorisation process for DEHP, which is used 
as a plasticiser, largely in th e manufacture of flexible PVC, cannot be predicted. The main 
industry stakeholder argued that  DEHP should not be designated  a PHS. However, the listing 
of DEHP in Annex XIV already implies eventual substitution and phase-out provided suitable 
alternative substances or techno logies are economically and tec hnically viable. This would be 
consistent with PHS designa tion and contribute to the WF D objective of phasing out 
emissions to the aquatic environment. Howeve r, as noted in the above table, DEHP is 
widespread in existing construc tion materials in situ.  A high  proportion of its use is indoor, 
for example in flooring and flex ible water pipes, and this is considered to account for a high 
proportion of the emissions to water. Some outdoor use, for example in roofing materials, also 
contributes, but the PV C common in window frames, gutte ring and downpipes is, according 
to the information available, largely unplasti cised (i.e. rigid) and therefore should not 
contribute. Although the REACH process is likely to achieve complete substitution in the end, 
meeting the WFD objective within its 20-year tim eline could still impl y a need to replace 
existing (in situ) construction materials. Howe ver, any such action would be subject to 
consideration of the costs. Exemptions regard ing the 20 year deadline could be applied, as 
explained above, on the grounds of disproportiona te costs or technical non-feasibility. The 
assessment of early (before end-of -life) replacement costs would need to take into account the 
 
EN 41   EN disposal/recycling costs,  including those to the environmen t. The emissions of DEHP to the 
environment from incineration and landfill have been calculated in the EU Risk Assessment Report to be very low compared with those from use, but the cost of manufacturing 
replacement materials would also have to be considered. As noted above, guidance on 
applying exemptions is available
33.  
Regarding other existing PS: On Trifluralin, comm ents were received from the main industry 
stakeholder questioning whether it  should be designated a PHS in the absence of confirmation 
of POP classification, but it is cl early a PBT. On PAHs, over half  of MS drew attention during 
the review to analytical difficulties with some PAHs because of their low EQS in water; the 
introduction of a biota EQS should help. 
5.2.4.  Analysis of impacts of Option A3a: Exis ting-PS changes plus Annex III substances 
As options for substances are cumulative, this option includes all imp acts of option A2 plus 
those described in this section. 
The additional monitoring costs (based on unit costs of 1-2.4 million € per substance, see 
Annex IV) are estimated at 4-9.6 million € per year (i.e. between 5 and 14% of the estimated current costs of monitoring of ex isting PS in EU 27, see Annex IV). 
5.2.4.1.  Summary of specific impacts per substance 
The table below summarises the specific imp acts per substance and section 2.2.3 outlines the 
main uses and reasons for concern. Other details  are provided in Annex V.  All the additional 
substances in this option are proposed as PHS. In all cases, the major positive impact (which would not be in the baseline) would be that  WFD monitoring would provide information on 
the extent of the problem and the effectiveness of the measures taken.  This would in turn 
provide feedback to other policies to inform  further decision making, e.g. to improve the 
efficacy of measures (where necessary), and a llow better targeting of sediment remediation. 
Substance Baseline*  Summary of significant specific 
impacts Remarks re substitu tion, SMEs, notable 
uncertainties 
Dicofol POPs legislation 
could become 
relevant. 
Recently excluded 
from Annex I of 
Directive 
91/414/EEC; 
emissions to water 
likely to fall. Positive:  See text above table. 
Coherence with and feedback to 
PPP policy. 
Negative : Potential local impacts if 
sediment remediation needed 
(more likely in ES, IT and/or FR 
than other MS).  Most impacts in baseline as authorisation 
recently withdrawn. Uncertainty re outcome 
of POPs negotiations, and re extent of failure 
of EQS in several MS due to inadequate 
sensitivity of analytical method. No negative 
impacts on SMEs expected. 
PFOS POPs legislation 
(Annex B) applies – 
restrictions on 
production and use. 
REACH – 
restrictions; IED; 
waste legislation 
(new limits 
proposed); will help 
to reduce emissions 
to water. Positive:  See text above table. 
Feedback to chemicals and waste 
policy. 
Negative : Potential local impacts if 
sediment remediation needed.  Most impacts in baseline. 
As regards SMEs: Possible local impacts on 
landfill operators though also likely to be in 
baseline. 
Uncertainty re timeline for availability of 
substitutes in aviation, photography, 
photolithography (temporary exemptions in 
baseline), and re extent of failure of EQS in 
some MS. 
 
Quinoxyfen Regulation (EC) No 
1107/2009 criteria re Positive: See text above table. 
Feedback to PPP policy. Benefits Substitutes exist (including improved 
management practices), though question 
                                                 
33 European Commission, 2009b 
 
EN 42   EN PBTs could lead to 
wihdrawal of PPP 
authorisation in 
2014. 
Sustainable Use of 
Pesticides Directive 
could lead to 
decrease in 
emissions to water. for aquatic biodiversity.  
Negative : If authorisation 
withdrawn there would be 
substitution costs but not 
significant according to the 
available information. Largest 
impacts expected in MS with 
highest consumption (DE, ES, FR, 
IT), and in hops (due to there being 
fewer alternative products).  raised regarding possible increased risk of 
resistance development. 
As regards SMEs: possible impact on PPP 
formulators and retailers while market 
adjusts.  Possible impact on arable farmers 
(including possible need to change 
management practices). 
Phase-out would rely on non-reauthorisation 
following  scheduled review under PPP 
legislation, such that most impacts would in 
fact be in baseline. Uncertainy re outcome of 
that review, and re: exte nt of failure of EQS 
in absence of widespread monitoring to 
match widespread authorisation; possible 
decline in use as a result of resistance. 
Dioxins and DL-PCBs POPs legislation 
applies; IED and 
waste legislation – 
could all reduce 
emissions. Positive:  See text above table. 
Feedback to industrial emissions 
and waste policies Reduced risk of 
exceedance of food standard in 
fish. 
Negative : Potential for costs of 
cleaner energy to be passed on to 
consumers, within proportionate 
limits. Potential local impacts if 
sediment remediation needed. Most impacts in baseline. 
Uncertainties re extent of failure in many MS 
due to insufficient senstivity of analytical 
method. 
* WFD Programmes of Measures relevant in all cases; uncertain  impacts. See Annex V for in formation on other relevant 
legislation in baseline.   
The main positive and negative impacts of this op tion are summarised in the table in section 
5.3. 
In the case of Quinoxyfen, its  authorisation for use under Directive 91/414/EEC (i.e. its 
inclusion in Annex I) expires in 2014 and it w ill need to be reviewed. The results of the 
prioritisation process under the WFD will be pr ovided for the review process under the PPP 
policy, in order to inform future decisions. If the authorisation for using Quinoxyfen as a PPP 
were not renewed, there would be nega tive impacts on the producer and on 
formulators/retailers (although they  could be totally or partially compensated by substitutes). 
There would also be impacts on farmers due to the need to find substitutes, but several are 
authorised and available, though apparently fewe r for hops than for other crops. There is some 
concern that resistance to anot her group of fungicides used to prevent powdery mildew could 
increase (HGCA 2009). However, it should be noted  in this context that the WFD allows 20 
years for phase-out of emissions to be achieve d, compatible with the timescales over which 
industry could be expected to develop additi onal products and/or strategies to overcome 
resistance problems. It should also be noted th at alternative management  practices in hops can 
be used effectively to minimise the need for PPP treatment. In view of the new criteria in 
Regulation (EC) No 1107/2009 rega rding PBTs, withdrawal of authorisation, and therefore 
the impacts indicated here, would be expected to  fall within the baseline. Indeed, achievement 
of the WFD phase-out objective would rely on a decision under the PPP Regulation to refuse 
reauthorisation, and designation as a PHS under the WFD does not prejudge the outcome of 
the PPP review. The main industry stakeholder questioned the listing of  Quinoxyfen in view 
of the available monitori ng data (see section 5.2.2). 
Apart from monitoring costs, no  other significant impact of th is substance option is expected 
compared with the baseline. 
 
EN 43   EN 5.2.5.  Analysis of impacts of Option A3b: Exis ting-PS changes plus Annex III substances 
plus other new substances excluding pharmaceuticals 
As options for substances are cumulative this option includes all impact s of options A2 and 
A3a plus those described in this section. 
The additional (cumulative) monitoring costs (based on unit costs of 1-2.4 million € per 
substance, see Annex IV) are estimated at 12- 28.8 million € per year (between 17 and 41% of 
the estimated current costs of monito ring of PS in EU 27, see Annex IV). 
5.2.5.1.  Summary of specific impacts per substance  
The table below summarises the specific imp acts per substance and section 2.2.3 outlines the 
main uses and reasons for concern. Other details are provided in Annex V. Of the additional substances in this option, two (HBCDD and he ptachlor) are proposed as PHS. As in option 
A3a, WFD monitoring would provide informa tion on the extent of the problem and the 
effectiveness of the measures taken. This would in turn provide feedback to other policies to 
inform further decision making, e.g. to improve the efficacy of measures (where necessary), 
and, in the case of the two proposed PHS, allo w better targeting of sediment remediation. The 
option includes several PPPs and biocides.  Collectively, therefore, the option would 
contribute to reducing the potential  for the drinking water standard for total pesticides to be 
exceeded. 
Substance Baseline* Summary of significant specific impacts Remarks re substitution, 
SMEs, notable uncertainties 
Aclonifen PPP legislation. 
Recent introduction 
of compulsory buffer 
strips under Directive 
91/414/EEC, NAPs 
due under 
Sustainable Use 
Directive – could 
reduce emissions. Positive: See text above tabl e. Feedback to 
PPP policy. Benefits for aquatic biodiversity 
from enforciing the EQS.  
Negative : Stricter requirements might be 
needed locally to meet the EQS.  As regards SMEs: A need to 
take additiona l measures 
would affect arable farmers – 
but mostly in baseline. 
Uncertainty regarding extent of 
EQS exceedance in many MS 
due to lack of widespread 
monitoring and changes under 
PPP legislation.; uncertainty re 
peak concentrations. 
Bifenox PPP legislation: 
NAPs due under 
Sustainable Use 
Directive  - buffer 
strips and other 
measures could 
reduce emissions.  Positive: See text above tabl e. Feedback to 
PPP policy. Benefits for aquatic biodiversity 
from enforciing the EQS.  
Negative : Stricter requirements might be 
needed locally to meet the EQS.  As regards SMEs: A need to 
take additiona l measures 
would affect arable farmers – 
but mostly in baseline. 
Uncertainty regarding extent of 
EQS exceedance in many MS 
due to lack of widespread 
monitoring and changes under 
PPP legislation; uncertainty re 
peak concentrations.  
 
EN 44   EN Substance Baseline* Summary of significant specific impacts Remarks re substitution, 
SMEs, notable uncertainties 
Cybutryne Biocidal Products 
Directive – under 
review; outcome 
could affect 
authorisation. Positive:  See text above table. Feed-back to 
biocides policy. Stimulation of innovation to 
find additional alternatives.  Employment 
opportunities if more frequent mechanical 
cleaning/maintenance. Benefits for aquatic 
biodiversity from enforciing the EQS.  
Negative : Substitution costs if substitution is 
needed to meet the EQS.   Labour costs if use 
more frequent mechanical cleaning/maintenance. In creased shipping fuel 
costs/CO
2 etc emissions if alternatives less 
effective. Additional co sts might be passed on 
to consumers/passengers. Potential local 
impacts if sediment remediation is needed.  As regards SMEs: Possible 
impacts on coating 
formulators, dockyards, ship 
owners, fishermen, but low 
since not PHS. 
Limited number of available 
chemical substitutes.  Toxicity 
possibly not much lower, or 
little studied.  Natural biocides being investigated.  Non-
biocidal fouling release 
coatings (e.g. silicone-based) 
have been developed. 
Mechanical cleaning also 
possible. 
Uncertainties re outcome of 
biocidal products review, 
possible impact of national 
bans on use on small boats. 
Cypermethrin PPP legislation: 
NAPs due under 
Sustainable Use 
Directive  - buffer 
strips and other 
measures could 
reduce emissions. 
Biocidal Products 
Directive – under 
review; outcome 
could affect 
authorisation.  Positive:  See text above table. Feed-back to 
PPP and biocides policy. Benefits to 
biodiversity. Significant potential benefits to 
fisheries and angling.  
Negative : For its use on crops, stricter 
requirements might be needed locally as a 
result of WFD monitoring and the need to 
meet the EQS. Costs to textile factories of 
increased effluent treatment and costs of 
substitution if needed to meet the EQS, but 
none expected to be significant. Possible 
impact on use in sea-lice treatment by salmon farmers. As regards SMEs: A need to 
take additiona l measures 
would affect arable farmers – 
but mostly in baseline. Salmon 
farmers could be affected 
though EQS exist in DKand 
UK. 
Alternatives available if 
needed, e.g. hydrogen peroxide 
in salmon farming, alternative 
PPPs in agriculture. 
Uncertainties re extent of failure of proposed EQS in 
several MS in absence of 
sufficiently sensitive analytical 
method; extent of failure in 
UK following ban on use in 
sheep dipping in UK; extent to 
which used for sheep dipping 
in other MS; likely trend in use 
in agriculture and forestry; 
outcome of biocidal products 
review.  
Dichlorvos Biocidal Products 
Directive – under 
review; outcome 
could affect 
authorisation. 
Recently excluded 
from Annex I of 
Directive 
91/414/EEC  Positive:  See text above ta ble. Feedback to 
biocides policy Bene fits for aquatic 
biodiversity from enforciing the EQS.   
Negative : Possible reduction in range of uses, 
e.g. to indoor use, but no significant impacts 
likely unless authorisation withdrawn, in 
which case in baseline.  As regards SMEs: Possible 
impacts on product 
formulators, but likely only as 
part of baseline. Uncertainties 
re extent of failure of proposed 
EQS in several MS in absence 
of sufficiently sensitive 
analytical method; and re 
outcome of biocidal products 
review.  
 
EN 45   EN Substance Baseline* Summary of significant specific impacts Remarks re substitution, 
SMEs, notable uncertainties 
HBCDD POPs legislation 
could become 
relevant.  Inclusion 
in Annex XIV of 
REACH could affect 
authorised uses. IED 
and waste legislation 
could reduce 
emissions to water. Positive:  See text above table. Feed-back to 
chemicals and waste policy. Potential 
improvements for 
aquaculture/fisheries/angling; potential for 
improving human health ; stimulation of 
innovation; benefits to producers of 
alternatives including potential employment; 
employment in remediation work. 
Negative : Possible loss of employment at 
single production site in the EU, but likely to 
be in baseline. Potential local impacts if 
measures taken at local level to meet EQS or 
to remediate  sediments. Po Most impacts in baseline, 
including, e.g. impacts on 
product manufacturers, 
construction companies  and 
landfill operators, among them 
some SMEs,  
Substitutes being developed, 
but uncertainties re timeline for 
availability (none yet for certain types of polystyrene, 
though in pipeline) and 
environmental and health 
impacts. 
Uncertainties also re 
designation as POP; possible 
authorised uses under Annex 
XIV of REACH; impacts of 
waste disposal route 
(incineration cf landfill). 
Heptachlor/ 
heptachlor 
epoxide POPs legislation 
(including ban under 
Regulation (EC) No 
850/2004)) and 
exclusion from 
Annex I of Directive 
91/414/EEC 
responsible for 
reducing emissions.  Positive:  See text above ta ble. Benefits for 
aquatic biodiversity from enforciing the EQS 
by, e.g. additional water treatment or 
sediment remediation, thence better protection 
of human health from secondary poisoning.  
Negative : Potential local impacts if additional 
water treatment or se diment remediation 
undertaken.  Uncertainty re extent of failure 
of proposed EQS in several 
MS in absence of sufficiently 
sensitive analytical method. 
No negative impacts on SMEs 
expected.  
Terbutryn Biocidal Products 
Directive – under 
review; outcome 
could affect 
authorisation.  
Excluded from 
Annex I of Directive 
91/414/EEC within 
past 10 years.  Positive:  See text above table. Feed back to 
the biocides policy. Bene fits to biodiversity, 
and to angling. Sustainable Urban Drainage 
(SUDs) could have shared  benefits, e.g. flood 
control, energy savi ng.  Stimulation of 
innovation in construction to minimise need 
for biocidal coatings.  
Negative : Installation and maintenance of 
SUDs (variable costs depending upon type). 
Costs of  substit utes if needed. As regards SMEs: Possible 
impacts on coating 
formulators, construction 
industry, but low since not 
PHS. 
Limited information on 
substances that can be 
substituted on a like-for-like 
basis. Altenerative building 
and surface design possible, 
also mechanical cleaning. 
Uncertainties re outcome of 
biocidal products review; 
extent of failure of EQS now 
that no longer used as 
herbicide.  
* WFD Programmes of Measures relevant in all cases; uncertain  impacts. See Annex V for in formation on other relevant 
legislation in baseline.   
The main positive and negative impacts of this option are summaried in the table in section 
5.3. 
The outcome of reviews under other policies could re sult in the restriction of certain uses for 
PPPs or biocides, hence triggering substitution cost s. However, the data gathered do not allow 
quantitative assessment of costs. According to the information available, there are substitutes 
for all the substances, although for some this might be more difficu lt (in particular for 
Cybutryne and Terbutryn). Nevertheless, as they  are not identified as PHS, listing would not 
necessarily imply substitution.  For Cybutryne, the international nature of shipping and the 
relevance of the International Maritime Or ganisation's International Convention on the 
 
EN 46   EN Control of Harmful Anti- fouling Systems on Ships34 might need to be considered if national 
measures were not sufficient to allow achieveme nt of the EQS. For Cypermethrin, additional 
management measures might be needed locally  in salmon farming to ensure that it could 
remain in the portfolio of sea-lice treatments, as it still is in Scotland despite a national EQS. It should be possible to manage without subs titutes, but they exist for aquaculture (e.g. 
application of hydrogen peroxide ) and agriculture (alternative  pyrethroids) if needed, though 
some costs could arise in relation to vine weevil control in the (unlikely) event that 
Cypermethrin use could not continue (ADAS, 2010, HGCA 2009)
. The inclusion of 
Cypermethrin was questioned by the main indus try stakeholder as e xplained in section 5.2.2. 
5.2.6.  Analysis of impacts of Option A3c: Existing-PS changes plus Annex III substances 
plus other new substances including pharmaceuticals 
As options for substances are cumulative this option includes all impact s of options A2, A3a 
and A3b plus those described in this section.  
The additional (cumulative) monitoring costs (based on unit costs of 1-2.4 million € per 
substance, see Annex IV) are estimated at 15-36 million € per year (between 22 and 52% of the estimated current costs of monito ring of PS in EU 27, see Annex IV). 
5.2.6.1.  Summary of specific impacts per substance 
The three additional substances in this opti on are all pharmaceuticals, although one is also 
excreted naturally.  The table below summarises the specific impacts for these substances and 
section 2.2.3 outlines the main uses as well as the reasons for concern. Other details are provided in the text below the table and in An nex V. For these substances, as in the other 
options, a significant benefit of PS status is that WFD monitoring woul d provide information 
on the extent of the problem and the effectivenes s of any measures taken.  This would in turn 
provide feedback to pharmaceuticals policy. Si nce pharmaceuticals have not hitherto been 
regulated under the WFD, their regulation would bring new elements into play, notably public 
health considerations. The three substances un der consideration are di fferent in character 
(uses, sources, alternatives) and therefore al so from a regulatory point of view (see Annex 
VI). 
Substance Baseline* Summary of significant specific 
impacts Remarks re subs titution, SMEs, 
notable uncertainties 
17 alpha-
ethinylestradiol Urban Waste Water 
Treatment Directive 
(UWWTD). 
Pharmaceuticals 
(including 
pharmacovigilance) legislation. 
Take-back schemes. Positive: See text above table. 
Benefits for aquatic biodiversity, 
especially fish, from meeting the 
EQS, due to lower endocrine 
disruptive exposure. Benefits to 
commercial and recreational fishing. Lower risk of drinking 
water containing the substance 
hence potential savings in 
drinking water treatment.  
Negative : Potential local costs if 
additional waste water treatment 
undertaken. (See text below re 
possible costs.) Possible one-off 
costs in the longer term for 
pharmaceutical companies to 
switch to alternative products, Substitute (progestogen) exists for  
contraceptive pill use that exhibits lower 
impacts on aquatic wildlife and higher 
removal rates in conventional waste 
water treatment plants, though not 
necessarily suited to all patients. Other contraceptive methods also available 
(though may be less effective). 
Doctor/patient choice maintained, but 
could be influenced by information 
about environmental impact. 
As regards SMEs: A possible shift in the 
long term towards substitute(s) (through 
changed prescripti on practices) would 
involve medical practices and 
pharmacies but would be unlikely to 
have any significant negative impacts. 
                                                 
34  http://www.imo.org/about/conventions/listofconven tions/pages/international-convention-on-the-
control-of-harmful-anti-fouling-systems-on-ships-(afs).aspx   
 
EN 47   EN Substance Baseline* Summary of significant specific 
impacts Remarks re subs titution, SMEs, 
notable uncertainties 
but overall market maintained. Expa nsion of take-back schemes could 
involve some costs but also some 
benefits for public authorities and waste-
handlers. Water companies could face 
higher costs if additional waste water 
treatment required, but substitution and 
take-back expansion should benefit them 
and drinking water treatment costs can 
be reduced. Uncertainty regarding variation in EQS 
exceedance across MS. 
17 beta-
estradiol (E2) Urban Waste Water 
Treatment Directive 
(UWWTD). 
Pharmaceuticals 
(including 
pharmacovigilance) 
legislation: 
Take-back schemes. 
Nitrates and pesticides 
legislation related to 
slurry spreading and 
buffer strips.  Positive: See text above table. 
Benefits for aquatic biodiversity, 
especially fish,   from meeting 
the EQS, due to lower endocrine-
disruptive exposure. Benefits to 
commercial and recreational 
fishing. Lower risk of drinking 
water containing the substance 
hence potential savings in 
drinking water treatment.  
Negative : Potential local costs if 
additional waste water treatment 
undertaken and/or livestock 
farmers need to fence water 
courses beyond the requirements 
under other legislation. (See text 
below re possible costs.) Substitution of limited relevance. 
As regards SMEs: Livestcok farmers 
could face additiona l costs for fencing 
water courses. Expansion of take-back 
schemes (limited rele vance for E2) could 
involve some costs but also some 
benefits for public authorities and waste-
handlers. Water companies could face 
higher costs if additional waste water 
treatment required, but source-control 
measures should reduce the need for this 
and drinking water treatment costs can 
be reduced. 
Uncertainty regarding variation in EQS 
exceedance across MS.  
Diclofenac Pharmaceuticals 
(including 
pharmacovigilance) 
legislation: 
Take-back schemes. Positive: See text above table. 
Benefits for aquatic and other 
biodiversity from meeting the 
EQS. Benefits to commercial and 
recreational fishing.  
Negative : Potential local costs if 
additional water treatment 
undertaken. (See text below re 
possible costs.) Possible one-off 
costs in the longer term for 
pharmaceutical companies to 
switch to alternative products, 
but overall market maintained.  Substitute NSAIDs ex ist with similar 
therapeutic efficacy that are easier to 
remove in UWWTPs. Doctor/patient 
choice maintained, but could be 
influenced by information about 
environmental impact. 
As regards SMEs: A possible shift in the 
long term towards substitute(s) (through 
changed prescripti on practices) would 
involve medical practices and 
pharmacies but would be unlikely to 
have any significant negative impacts. 
Expansion of take-back schemes could 
involve some costs but also some 
benefits for public authorities and waste-
handlers. Water companies could face 
higher costs if additional treatment 
required, but substitution and take-back 
expansion should benefit them. 
Uncertainty regarding variation in EQS 
exceedance across MS.  
* WFD Programmes of Measures relevant in all cases; uncerta in impacts. See Annex V for additional information on the 
baseline.   
All three have been used for several years as ph armaceutical ingredients, and 17 beta-estradiol 
(E2) is also naturally excret ed by humans and other mammals.  The benefits deriving from 
their pharmaceutical appli cation are reflected in their widespr ead use. However, they can pose 
a significant risk to th e aquatic environment if their concentration is hi gher than the proposed 
environmental quality standard, as is f ound and has been indicated in section 2.2.3. 
Although their addition to the PS list would be aimed principa lly at gathering monitoring data 
in the immediate future, this section presents measures that might be used by MS to address 
the potential environmental risk  posed by them. It is not possi ble to assess the costs and 
 
EN 48   EN benefits of such measures in detail, as explained in section 5.2.1.1. However, some cost 
estimates are presented below. 
Although one possible measure would be end-of-p ipe treatment (improvement of UWWTPs). 
source-control measures might be more cost-eff ective. They could contribute to reducing the 
need for and cost of end-of-pipe treatment.  
As mentioned in section 2.3, a significant source of emissions of pharmaceuticals, despite the 
existence of take-back schemes, is the dispos al of unused products. In the absence of good 
knowledge regarding the functioning of these sche mes, including of thei r set-up (e.g. whether 
financing is public, private or mixed), it is difficult to assess the impacts of change. However, the figures cited in section 2.3 s uggest that there is room for improvement  (as confirmed by 
the Pharmaceutical Group of the European Un ion). This could significantly reduce the 
emissions of Diclofenac and EE2. 
Another approach to consider would be the promotion of more en vironmentally-friendly 
alternatives. For example, se veral Non-Steroidal Anti-Infla mmatory Drugs (NSAIDs) exist 
that could be used instead of Diclof enac, with similar therapeutic efficacy
35 but allowing 
easier removal in conventional UWWTPs (Roig 2010). Information to patients, doctors and 
pharmacists about the environmenta l impact of medicines could in fluence prescription if there 
were valid alternatives, as is the case for Diclofenac.  In Stockholm (SE), an Environmental 
Classification System was established in 2005 that includes information to doctors, 
pharmacists and patients, leading to a significa nt impact on the prescription behaviour of 
health professionals, although comp rehensive information on the su ccess of the scheme is not 
available (Knappe 2008). 
The oral pharmaceutical a lternative to EE2-based oral contraceptives is the progestogen-based 
"mini-pill" which currently has an estimated market share of  8.5%. The efficiency of the 
contraception is identical ( 0.3 unintended pregnancies per 10 0 women). However, the EE2-
based pill is not replaceable in all cases by the progestogen-based mini-pill.. Progestogens are 
also endocrine disrupting substanc es but the rate of removal in waste water treatment plants is 
significantly higher than for EE2 (Roig 2010; Chang. et al,  2011). 
As regards E2, improved take-back schemes woul d be relevant to its pharmaceutical use, but 
the main measures would have to focus on reducing emissions due to natural human and 
livestock excretion which account for 90% of total emissions, e.g. improvements to UWWTPs and protection of water courses from livestock excreta; the former would reduce 
emissions also from the pharmaceutical uses.  
As stated above, source control measures might be  more efficient than end-of-pipe treatment. 
In selecting the most cost-effective measures MS would need to take  into account the timing, 
in particular the fact that the EQS are not to  be achieved in the short term, but only 10 years 
                                                
 
35  To name a few aspirin, naproxen, ketorolac, ketoprofen, meloxicam, celecoxib, mefenamic acid, 
etoricoxib, indometacin, ibuprofen. See for example information at the National Health Service of 
England http://www.nhs.uk/Conditions/Anti-inflammato ries-non-steroidal/Pages/Introduction.aspx  and 
http://www.nhs.uk/Livewell/Pain/Pages/Whichpainkiller.aspx  which presents various alternatives 
depending on the characteristics of the patient; th e Prescription Guide of the Spanish Medicament 
Agency http://www.imedicinas.com/GPTage/Open.php?Y2ExMHNlMDFzYjAx  that indicates that 
"differences in anti-inflam matory activity of different NSAIDs are small, but there is great variation in 
tolerance and response of each patient. Approxim ately 60% of patients respond to any NSAID, and 
40% respond to one or another". 
 
EN 49   EN from now, and that there are possibilities for exemptions to extend the deadline on grounds of 
disproportionate cost or tec hnical non-feasibility.  As noted above, guidance on applying 
exemptions is available36.  
It is however not possible to estimate how mu ch end-of-pipe treatment would be needed 
across the EU. This is very much dependent on local conditions. Neve rtheless, some cost 
estimates for upgrading UWWTPs to remove E2 ar e available; they assume that no source-
control measures are taken and in that respect represent worst-case scenarios. 
• For England and Wales (UK), an estimate of 18 € per inhabitant per year was derived37. 
based on a modelling exercise using an EQS stricter than the one proposed (2.7 10-4 
μg/l instead of 4.0 10-4 μg/l). 
• For Switzerland, an increase of 5 to 25% in relation to conventional treatment costs 
depending upon the size of the plant has been  estimated, resulting overall in 11-18 € per 
inhabitant per year depending on the number  of plants to be upgraded (Abegglen et al, 
2009). 
These costs would fall on water companies (som etimes SMEs) but would likely be passed to 
consumers in full or in part in higher water bills, within proportionate limits. The increased 
treatment would result in a significant increase in energy use due to the increased treatment 
(equivalent to 1 million tons of CO 2 in England and Wales, an in crease of 20% in relation to 
the current energy consumption in UWWTPs). On the other hand, the technologies used for 
the enhanced treatment would also eliminate many other pollutants and thus improve the 
quality of the discharge significantly, making it easier to treat water downstream for the 
production of drinking water and therefore impl ying potential savings. Additional benefits are 
discussed in section 5.2.1.1. 
The cost of fencing to avoid livestock access to water courses is estimated at between 2 and 
12 €/ha/year (quoted in Entec 2011); it is not possi ble to estimate how mu ch fencing would be 
required in total.  The costs could fall largely on livestock farmers (generally SMEs) but be attributed in part to requirem ents under other legislation such  as the Nitrates Directive. 
As mentioned above, not only the co sts but also the bene fits of applying m easures (as noted in 
the table) are difficult to quantify. However, on the basis of the evidence for concern noted in 
section 2.2.3 and the generic benefits presen ted in section 5.2.1.1 including the value of a 
resilient aquatic ecosystem, si gnificant benefits from meeti ng the EQS would be expected. 
Uncertainties in the assessment of benefits and costs arise not only from uncertainties in the 
extent of exceedance of the EQS in different  MS given the limited monitoring coverage and 
often inadequate analytical sensitivity, but also  from the absence of information on production 
of the substances in the EU, and from the limited experience of reducing the environmental 
impact of pharmaceuticals in use. These uncerta inties suggest that until further monitoring 
data have been gathered to inform the polic y making, it would not be appropriate to propose 
measures at EU level; measures to influence pr escription could in fact only be taken at MS 
level since there are currently no mechanisms in the EU legislation to do this. However, the 
evidence of pollution is considered sufficient to  include E2, EE2 and Dicl ofenac in the list of 
                                                
 
36 European Commission, 2009b 
37 See Entec 2011, report for E2, Append ix B. Per capita cost calculated on th e basis of average annual costs and 
54 million inhabitants in England and Wales. 
 
EN 50   EN PS and to establish an EQS at EU level. In addition to reviewing the monitoring data, the 
Commission will explore in its study on the environmental impact of pharmaceuticals the 
need to provide mechanisms to address the issue at EU level. 
During the consultation process the pharmaceutical industry expressed clearly its opposition 
to the inclusion of any pharmaceutical on the list of WFD priority substances, favouring a 
more holistic approach towards regulating th e environmental impact of pharmaceutical 
products. On the other hand, the environm ental NGOs favoured inclusion. No other 
stakeholder indicated a clear preference for one or another substance option, although 
comments were made regarding some individual substances, as reported above. The fact that 
all the substances reached this stage of the review reflected the existence of concern about 
them. 
5.3. Comparison of the substance options 
In the following table the options A1 to A3 are compared.  
Effectiveness is compared on the basis of the obj ectives set out in section 3.The diversity of 
impacts covered by the different options does not allow an overall assessment of efficiency. 
As an alternative, the main positive and negativ e impacts of the options are presented in the 
table. The cost of monitoring the existing PS is estimated at 69m € per year (see Annex IV). 
Option Effectiveness Main positive impacts  Main negative impacts  
A1: No change 0   
A2: Existing PS  + 
Improved knowledge of the 
extent of the risks from existing 
PS (through the setting of biota 
standards for poly-BDE, PAH 
and Fluoranthene). 
No improved knowledge of the 
risks posed by newly identified 
substances.  
Latest scientific information on 
the risks posed by additional 
substances not  considered. 
Failure to optimise protection 
against identified risks from new 
substances not included in the 
PS list. Better and more robust 
knowledge of the extent of the 
risks, coherence of the existing 
EQSs with the latest scientific 
and technical progress developed 
in the context of the chemicals 
policy, which would allow MS 
and other policies to take the 
necessary measures to reduce the risks caused by these substances 
to or via the aquatic 
environment. 
Improved protection of human 
health and aquatic biodiversity. Potential significant costs to 
upgrade some industrial and 
UWWTPs (for Nickel), 
depending on local conditions. 
Costs would fall initially on 
water authorities/companies and 
industries but likely be passed to 
consumers, within proportionate 
limits. 
 
 
EN 51   EN Option Effectiveness Main positive impacts  Main negative impacts  
A3a: Existing 
PS plus Annex 
III substances ++ 
Improved knowledge of the 
extent of the risks from existing 
PS (through the setting of biota 
standards for poly-BDE, PAH 
and Fluoranthene) 
Very limited improvement in 
knowledge of the risks posed by 
newly identified substances.  
Latest scientific information on 
the risks posed by several 
additional substances not 
considered. 
Failure to optimise protection 
against identified risks from 
several substances not included 
in the PS list. As above plus: 
Information about the presence 
of and  extent of the risk caused 
by the additional substances and 
about the effectiv eness of largely 
baseline measures at reducing or 
phasing out emissions. Valuable 
data and information for 
decision making on targeted 
remediation and in the context of the PPP, chemicals, industrial 
emissions and waste policy. 
Additional protection of human 
health and aquatic biodiversity. As above plus: 
Estimated additi onal monitoring 
costs of 4 – 9.6m € per year, 
which would fall on MS.  
Possible substitution costs for 
Quinoxyfen if not in baseline; 
could fall on the producers, 
formulators, farmers and/or 
consumers depending upon the 
substitute. 
A3b: Existing 
PS plus Annex 
III plus other 
new excluding 
pharmaceuticals +++ 
Improved knowledge of the 
extent of the risks from existing 
PS (through the setting of biota 
standards for poly-BDE, PAH 
and Fluoranthene) 
Significant improvement in 
knowledge of the risks posed by 
newly identified substances.  
Latest scientific information on 
the risks posed by 
pharmaceuticals not considered. 
No protection provided for 
identified risks from 
pharmaceuticals. 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. As above but: 
Estimated additi onal monitoring 
costs of 12 – 28.8m € per year, 
which would fall on MS; 
plus 
Possible costs to 
producers/formulators/consumers 
of substitutiing  Cybutryne and 
Terbutryn (though not PHS); 
possible reduction in portfolio of 
treatment options for sea-lice in 
salmon farming if Cypermethrin 
could no longer be used for that 
purpose. 
 
A3c: Existing 
PS plus Annex 
III plus other 
new including 
pharmaceuticals ++++ 
Improved knowledge of the 
extent of the risks from existing 
PS (through the setting of biota 
standards for poly-BDE, PAH 
and Fluoranthene) 
Very significant improvement in 
knowledge of the risks posed by 
newly identified substances.  
Latest scientific information on 
the risks fully considered. 
Protection optimised against 
identified risks from all the 
prioritised substances. As above plus: 
Improved information on the 
extent of pollution by 
pharmaceuticlas, and  EU-wide 
EQS as benchmarks for deciding 
measures at MS level.  
Additional protection of human 
health and aquatic biodiversity. As above but: 
Estimated additi onal monitoring 
costs of 15 – 36m € per year, 
which would fall on MS; 
plus: 
Possible costs of additional 
UWWTP upgrades to remove E2 
if locally required and not 
sufficient in option A2. Costs 
would fall initially on water 
authorities/companies but likely 
be passed to consumers, within 
proportionate limits.  Costs for 
livestock fencing could fall on 
farmers. 
Magnitude of impact as compared with  the baseline scenario (the baseline is indicated as 0) + means positive 
(number of + indicates magnitude)  
No disproportionate costs have been identifie d at EU level, and option A3c achieves the 
objectives to the greatest exte nt as it contains the complete outcomes of the prioritisation 
process. Option A3c is ther efore the pref erred option. 
 
EN 52   EN If MS found that disproportioan te costs would be incurred lo cally, the exemptions under the 
WFD could be used for particular water bodies  if the conditions set out in the WFD were 
fulfilled, as explained in section 5.2.1.2. Accordi ng to the available information, though, it is 
unlikely that such disproportionate costs would ar ise at many locations, except in the case of 
ubiquitous PBTs. MS would inevitably consider  the implications for newly identified PS of 
their existing Programmes of Measures before considering the need for further measures. 
Some of them might already have been includ ed as RBSPs or be affected by measures for 
other substances. 
Option A3c ensures gathering of data to inform measures locally and pos sibly at EU level for 
all the prioritised substances. If  the available information were not sufficient to decide on the 
need for measures at the time of adopting the Programmes of Measures , MS would be 
expected to identify, in their Programmes, the monitoring require d to inform this decision, as 
well as the monitoring required to judge the ef fectiveness of any me asures.The estimated 
monitoring costs are calculated linearly on the basis of a unit cost per substance (see Annex 
IV). This approach, which has the merit of si mplicity, overestimates the costs for the options 
with the largest number of substances. These will have a better cost ra tio per substance since 
sampling costs  increase less st eeply as the number of substan ces increases. Further, should 
upgrades to UWWTPs be require d, or sediment remediation be undertaken, the costs per 
substance would decrease, i.e. they should not be multiplied by the numbe r of substances. The 
benefits would extend beyond the targeted substances.  
5.4. Analysis of impacts of options in  relation to the ubiquitous PBTs 
In the consultation phase, the identification of  options to address th e problems relating to 
ubiquitous PBTs was welcomed particular ly by MS, but also by stakeholders.  
5.4.1.  Analysis of impacts of Option B2a on pr esentation: Give more flexibility on 
presentation  
This is a relatively simple option that allows MS to adapt the presentation of the chemical 
status in the RBMP, separating ubiquitous PBTs and the rest of the substances. No significant 
costs are identified for this option. Some small costs might be involved in the production of 
different maps for the plans, but these are no t considered significant. As regards potential 
negative impacts, as this option would not ob lige MS to present PBTs separately, some 
discrepancy in presentati on of the results between  MS might occur.   
In terms of benefits, the flexibility in the pres entation would still maintain legal certainty as 
the definition of chemical status  would not change. There would also be some administrative 
savings as MS would not need to justify in  the RBMP the situation as regards ubiquitous 
PBTs, but would use the rationale  provided in the EU legislation to present separately the 
information on these substances . It should be recalled th at the RBMP are subject to 
compulsory public consultation.  
5.4.2.  Analysis of impacts of Option B2b on pr esentation: Take ubiquitous PBTs out of 
chemical status 
This would represent a major change in the WFD and EQSD. It would reduce the level of 
environmental protection because there woul d be no EU EQS and no driver for taking 
measures. 
 
EN 53   EN The first implementation cycle of the WFD has not  yet ended . Changing the goal posts before 
the 2015 deadline for achieving the objectives woul d create legal uncerta inty. This option is 
also not fully consistent with the general objec tives of the WFD to establish a high level of 
protection for the aquatic environment, as it would exempt some of the most dangerous 
substances from key obligations of the Di rective.  However, it would be a very 
straightforward way of addressi ng the problem of presentation. 
The environmental NGOs expressed concern about both options B2a and B2b effectively 
because they considered that less attention w ould be given to the problem of ubiquitous PBTs. 
Most MS favoured option B2a. 
5.4.3.  Analysis of impacts of Option B3a on choice  of matrix: Leave flexibility but link the 
choice to requirements of Directive 2009/90/EC 
The main driver for the choice of the matrix shou ld be the intrinsic properties of the substance 
and its environmental fate, together with the possibilities to effectively monitor the environmental concentrations to manage risks. Ho wever, flexibility in the choice of matrix is 
highly appreciated by MS. and factors such as tradition and experience in the MS, the expertise in the nationa l laboratories and the maintenance of long time series of monitoring 
data could play a role. For example IT has a long  tradition of monitoring  sediments in coastal 
and transitional waters. Independently of the discussion ab out the appropriateness of setting 
standards at EU level for sediment and biota,  some MS consider that water standards are 
useful in any case for the purpose of setting em ission limits in the permits for waste water 
discharges, even when far below the sensitivit y of state-of-the-art analytical techniques. 
Where it is possible to monitor re liably in any of the matrices , leaving MS the choice of the 
matrix allows them to take advantage of their experience and expertise. 
This option, while also providing flexibility to  adapt monitoring strategies quickly to progress 
in analytical techniques would at the same  time lead to improved harmonisation of the 
assessment of chemical status. Adaptation costs might be faced by MS without experience in 
monitoring and analysing specific su bstances in certain matrices.  
This option might introduce lack of legal clarity if there are no standard international 
analytical methods for certain substances , with internationally accepted analytical 
sensitivities. If this is the case, it will not be straightfo rward to assess which available method 
performs better and it could depend on the laboratory.   
5.4.4.  Analysis of impacts of Option B3b on choice of matrix: Fix the preferred matrix for 
each substance 
A preferred matrix could be selected for each su bstance on the basis of the intrinsic properties 
and environmental fate and taking into account the performance of the best available monitoring technique. This would ensure a high level of harmonisation of  the assessment of 
chemical status. 
On the other hand, for some substances the pref erred matrix is not clear cut and may depend 
on the local environment and nature of the emissions. 
Adaptation costs might be faced by some MS wi thout experience in monitoring and analysing 
specific substances in certain matrices. There would be no possibility to adapt quickly to 
 
EN 54   EN progress in analytical techniques that could im prove the sensitivity in certain matrices. This 
could hinder progress in the development of an alytical techniques for these other matrices. 
One of the advantages of this option is the lega l clarity it would provide, as the matrix would 
be fixed at EU level. 
As implied above, more MS favoured maintaining some flexibility in the choice of matrix, 
although some favoured fixing the matrix in or der to ensure comparability of results. 
5.4.5.  Analysis of impacts of Option B4a on m onitoring: Introduce re duced monitoring 
obligations for ubiquitous PBTs if cert ain specified conditions are met  
Costs could be saved because of reduced mon itoring effort and reduced administrative burden 
for MS; the justification for th e reduced effort would be in the EU legislation. The option 
could cover up to 8 ubiquitous PBTs (the 4 ex isting PS and 4 proposed), but the estimates in 
this section only cover the 4 existing (see section 5.7.1 for interactions between options). 
It is estimated that the reduction in monitoring  effort could save be tween 20 and 30% of the 
monitoring costs. This is a conservative estimat e, since the default frequency in water is 
monthly (WFD Annex V) and in sediment and biota it is annua lly (EQSD Article 3.2c). The 
potential reduction in frequency of  analysis for the water matrix is estimated to be from 12 
samples per annum to 1 or 2 and for biota from  1 per annum to 1 every two or three years. 
This would give potential reductions of betw een 50% and 90%. In addition there could be 
additional savings by reducing th e number of monitoring points to take into account the 
ubiquitous nature of the substances. However, taking into account the uncertainty as regards 
the availability of a robust mon itoring baseline in all MS, the pot ential savings are reduced to 
an estimate of 20-30%. These savings are considered achievable in the short term. 
If monitoring costs were reduced for all exis ting 4 ubiquitous PBTs in the 20-30% range, 0.8 
to 2.9 million € per annum could be saved across the EU (between 1 a nd 4% of the overall 
estimated current costs of  monitoring of PS).  
The reduced administrative burden arising from not having to justify reduced monitoring 
effort for each of the substances is estimated  at several man-days of work per RBMP. There 
are 176 RBDs. However, some countries have a strong national approach to implementating 
the WFD and would probably reuse the administra tive effort for all or several of their RBDs 
(e.g. UK, IE, AT, PL, PT, NL). If this were take n into account, justification would be derived 
first hand for only about 120 RBDs. If applied to  all 4 existing ubiquitous PBTs, the savings 
would amount to 1000 to 2500  man-days  across the EU per RBMP cycle.  
5.4.6.  Analysis of impacts of Option B4b on m onitoring: Introduce re duced monitoring 
obligations for ubiquitous PBTs (unconditional) 
In the long term, the reductions  in monitoring costs and administ rative burden would likely be 
the same as those under option B4a.  However,  the absence of a re quirement for a robust 
baseline could reduce the monitoring  costs still further in the shor t term.  At the same time, it 
would mean that certain undesirable trends or hotspots could be overlooked. Although the 
ubiquitous nature of the pollution from these substances means that differences between MS are likely not to be significant overall, local di fferences for some substances could be large 
(e.g. in water bodies that were/are subject to dire ct emissions compared w ith water bodies that 
are impacted by atmospheric deposition). 
 
EN 55   EN MS were generally in favour of reducing the monitoring obligation for ubiquitous PBTs. The 
few MS who expressed a preference for one or  other option were approximately equal in 
number.  
5.5. Comparison of options in relation to the ubiquitous PBTs 
In the following table, options B1, B2a and B 2b,  options B1, B3a and B3b, and options B1, 
B4a and B4b are compared in their respective sets with regard to their effectiveness, 
efficiency and consistency, taki ng account of the objectives in  section 3 and the existing 
legislation. 
Option Effectiveness Efficiency  Consistency Overall 
mark 
B1: No change 0 0 0 0 
Options on presentation  
B2a: More flexibility on 
presentation ++ 
Avoids presentational issue 
although formally chemical 
status would still  be affected 
by the ubiquitous PBTs. ++ 
Efficient as no major costs 
involved and reduced 
administrative burden for MS. + 
Retains coherence 
with the objectives of 
the WFD, providing 
more flexibility in 
terms of presentation 
of information on 
status. +++++ 
B2b: Take 
ubiquitous PBTs out 
of chemical status  + 
Avoids presentational issue 
completely but undermines the 
objective of reducing the risks 
posed by certain substances. ++ 
Efficient as no major costs 
involved and reduced 
administrative burden for MS. -- 
Incoherent with the 
overall objectives of 
the WFD and of 
chemicals policy. + 
Options on monitoring matrix  
B3a: Leave 
flexibility but link 
the choice of matrix 
with requirements of 
Directive 
2009/90/EC ++ 
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/experience.  
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: Fix the 
preferred matrix for 
each substance ++ 
Strong driver for using the 
most appropriate matrix. 
Contributes to improved 
knowledge of the risks of 
substances and effectiveness of 
measures. Difficult choice in 
some cases. 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 scientific and 
technical progress in 
analytical techniques. 
Could hinder progress 
in analytical 
techniques for other 
matrices. + 
Options on reduced monitoring  
 
EN 56   EN Option Effectiveness Efficiency  Consistency Overall 
mark 
B4a: Reduced 
monitoring 
obligations if certain 
specified conditions 
are met + 
Reduces administrative burden 
and monitoring costs for MS.  + 
Ensures that a robust 
monitoring baseline is 
available, hen ce contributing 
to good knowledge of the 
risks to or via the aquatic 
environment of ubiquitous 
PBTs. ≈ ++ 
B4b: Reduced 
monitoring 
obligations 
(unconditional) + 
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. ≈ + 
Magnitude of impact as compared w ith the baseline scenario (the baseline is indicated as 0): ++ strongly 
positive; + positive; – – strongly negative; – negative; ≈ marginal/neutral  
Therefore the preferred options are B2a, B3a and B4a. 
5.6. Analysis of impacts of options to improve the knowledge base 
5.6.1.  Analysis of impacts of Option C2: Estab lish a watch list with out legal obligation. 
Monitoring costs would be the most important cost s associated with this option: estimated at 2 
to 4 million € per year for the EU (between 3 and 6% of the overall estimated current costs of monitoring of PS, see Annex IV). These cost estimates were considered reasonable by MS 
and the JRC. 
There would be some administrative costs to  develop the technical specifications for 
monitoring. These would arise fr om the need to hold meetings of MS and stakeholder experts 
(estimated 3 per year with 40 participants) and  additional work of an average of 10 working 
days per substance. This would result in addi tional administrative costs of 0.2 million € per 
year. These figures are based on  the experience of the Chemical Monitoring and Emerging 
Pollutants (CMEP) sub-group. In fact, the costs a ttributable to the optio n would be lower as 
the CMEP group would meet anyway to  deliver on the CIS work programme. 
The lack of a legal obligation would produce uncertainties in th e outcome due to pressures on 
MS to prioritise lega l obligations in their budgets . This is evidenced by the fact that the rate of 
reporting to the EEA of new voluntary data streams is low, e.g. emissions to water, only 6 MS 
reporting fully according to specifications , 10 MS have not reported at all. 
Further, participating MS would unfairly carry the costs, and due to non-participants it might 
not be possible to draw an EU picture and th erefore the usefulness of the expenditure would 
decline significantly. 
5.6.2.  Analysis of impacts of Option C3: Estab lish a watch list with legal obligation 
The costs of this option would be similar to those for option C2. Howe ver, there would be 
some additional costs for comitology and administration within the Commission. 
 
EN 57   EN The legal obligation would make the outcome mo re certain to meet the objectives, i.e. to 
provide EU-wide datasets, and ensure fa irer sharing of the costs among MS.  
Both MS and stakeholders supported the idea  of the watch list, a few indicating their 
preference as regards the formal status (2 fo r legal obligation, 3 for voluntary approach, 5 no 
position). 
5.7. Comparison of the options to improve the knowledge base 
 
Option Effectiveness Efficiency  Overall 
mark 
C1: No change 0 0 0 
C2: Establish a watch list 
without legal 
obligation + 
Increased knowledge but likely to suffer 
important data gaps (incomplete coverage 
of MS) and lack of a dherence to technical 
specifications due to the voluntary 
character. + 
Value for money (i.e. return on MS 
administrative - including  monitoring - costs)  
limited by the likelihood of data gaps. ++ 
 
C3: Establish a 
watch list with 
legal obligation ++ 
Increased knowledge and likely to cover 
all or most of the EU countries in a 
harmonised way (i.e. following the 
technical specifications) ++ 
Very high efficiency (i.e. return on MS 
adminstrative – including monitoring - costs)  
as the watch list would provide targeted high-
quality EU datasets that would be fit for purpose for PS prioritisation. ++++ 
 
Magnitude of impact as compared w ith the baseline scenario (the baseline is indicated as 0): ++ strongly 
positive; + positive; overall mark is sum of individual magnitudes.  
Therefore the preferred option is C3. 
5.8. Cumulative impacts, interactions acro ss the various options and significant 
distributional effects 
5.8.1.  Interactions and cumulative impacts 
There are a number of links between the various options. 
• As regards the substances: 
o Options including new substances imply a ne t increase in monitori ng costs (for public 
authorities) of 4-9.6 million € per year for option A3a, 12-28.8 million € for option 
A3b and 15-36 million € for option A3c. Although the same unit costs have been used for all options, it is likely that the options with a larger number of substances would 
benefit from smaller unit costs per substance,  as costs such as sampling increase less 
steeply as the number of substances increases.  
o There are two substances for which end-of -pipe measures (in particular advanced 
treatment of urban waste water) have been identified as potentially effective and possibly requiring local implementation (Nicke l and E2). Since ther e would likely be 
an overlap between the locations (with hi gh population density) requiring upgrade of 
UWWTPs under option A2 (for Nickel) and under option A3c (for  E2), the costs 
would not be additive. If these measures we re implemented for Nickel and E2 they 
would also have a positive impact on reducing the emissions of other pollutants 
 
EN 58   EN covered in this impact assessment (e.g. L ead, DEHP, BDEs, HBC DD), other existing 
PS (Mercury, Cadmium, Nonylphenol, etc) an d many other pollutant s, representing 
good value for the investment by public au thorities or private companies (and 
indirectly the consumers). 
• As regards options for subs tances and ubiquitous PBTs: 
o The establishment of biota standards for the ubiquitous PBTs among the existing PS 
(those identified in option A2 but included in all the substance options), and the 
change from water to biota monitoring that  options B3a or b w ould imply for those 
substances would result in higher rates of failure of EQSs. This would however 
provide a more accurate pict ure of  the risks posed by th ose substances and of the 
effectiveness of measures taken, and w ould allow MS to take better-informed 
decisions on the need to undertake re mediation at contaminated sites.  
o The extent to which the options addressing presentational aspects of ubiquitous PBTs 
would have an impact would depend upon th e choice of substance option; the impact 
would be greater, the more cumulative the substance option, sin ce it would relate not 
only to stricter EQS for existing substan ces but also additiona l ubiquitous PBTs.  
o If the ubiquitous PBTs were taken out of the chemical st atus assessment (option B2b), 
the general objective of  reduc ing the risks posed by substances would be affected, as 
the WFD would not constitute a driver for improvement anymore. 
o If any of the substance options A3 were se lected, the option B4 on reduced monitoring 
efforts would provide cost savings for the 2 to 4 additional new ubiquitous PBTs (2 
substances in option A3a and 4 in options A3b or A3c). Th e savings would be realised 
immediately in the case of option B4b or in the longer term in case of B4a, as for the 
latter a monitoring baseline would need to be established. The potential cost savings 
are estimated to be in the range of those calculated for the existing 4 ubiquitous PBTs 
(0.8 to 2.9 million € per annum across the EU). 
• As regards options for ubiquitous PB Ts and for improving the knowledge base: 
o New monitoring costs due to the watch list (2-4 million € per year) would likely be (at 
least partly, possibly totally in the long term) compensated by the estimated reductions 
in the monitoring costs for ubiquitous PBTs (0.8 to 2.9 million € per year in the short 
term, additional similar amount in the l ong term). The value for money, though, would 
be significantly greater for the watch list. 
• As regards the sub-options for ubiqu itous PBTs: Although the sub-options on 
presentation, monitoring matrix and frequency are independent,  
o providing flexibility in presentation or ta king ubiquitous PBTs out of the chemical 
status assessment could make it easier for MS to accept a shift towards more biota monitoring (whichever monitoring option a pplied); conversely, greater harmonisation 
of the monitoring matrix would be likely to lead to more comparable approaches to 
presentation under the flexible presentation option. 
o
 taking the ubiquitous PBTs out of the ch emical status assessment would already 
reduce the monitoring obligation to that re quired for trend monitoring.  Therefore the 
additional impact of adopting one of the options on reduced monitoring frequency 
would be lower than if the ubiquitous PBTs had not been taken out of chemical status. 
o fixing monitoring in the biota matrix woul d already reduce the monitoring frequency 
if MS were previously monitoring in wate r.  Therefore the additional impact of 
adopting one of the options on reduced mon itoring frequency would be lower than if 
the matrix had not been fixed in biota. 
 
EN 59   EN 5.8.2.  Cumulative impacts of the pa ckage of preferred options 
Taking account of the interactions outlined above and the information summarised in sections 
5.3, 5.5 and 5.7, the preferred options (all subs tances - A3c; flexible presentation for 
ubiquitous PBTs – B2a; choice of matrix linked to analytical sensitivity – B3a; conditional reduced monitoring for ubiquitous PBTs – B4a; and a watch list with legal obligation – C3) 
would be likely to have th e following main benefits: 
o all the latest scientific information reviewed would be taken into account; 
o MS would be encouraged to monito r in biota when most appropriate; 
o a more accurate picture would be obtai ned of pollution by ubiquitous PBTs; 
o there would be a significant improvement in  knowledge of the risks posed by all 15 of 
the prioritised substances and the ubiquit ous PBTs among the existing PS, and of the 
effectiveness of measures for these subs tances, allowing introduc tion/improvement of 
measures at EU and MS le vel, better targeting of sediment remediation, and 
optimisation of protection from identified risks - thus leadi ng to benefits to 
biodiversity and human health; 
o measures applied to reduce the risks from so me substances (e.g. Nickel) would be seen 
to reduce the risks from others (e.g. E2) as well; 
o the harmonisation of EQS for more substanc es would provide a more level playing 
field for businesses in different MS; 
o the administrative burden associated with e xplaining the failure of the chemical status 
objective as a result of ubi quitous PBTs would be re duced, and the public would 
receive clearer information; and 
o savings of approx 0.8-2.9 m € per annum on monitoring ubiquitous PBTs would be 
expected, which could be invested in im proving the information base for future 
prioritisation exercises, i.e. the watch list; 
 and the following main costs: 
o estimated additional monitoring costs, to public authorities, of 15 – 36m € per year for 
the whole of the EU; 
o costs to public authorities and private co mpanies, likely passed to consumers, of 
additional UWWT to remove Nickel and E2, co sts 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 and would be within proportionate limits; 
estimates for the UK (which has among the hi ghest Nickel concentr ations in the EU) 
are: whole-life costs of the order of 2 billion € to meet a 2 μg l
-1 EQS bioavailable  for 
Nickel by upgrading 2% of UWWTPs (fewer if EQS at 4 μg l-1), and less than 19 
billion € (upgrade of fewer than 9% of UW WTPs, 20-year lifetime cost which is in net 
present value) to meet a 4 10-4 μg l-1 EQS for E2, plus attend ant running costs (noting 
that the costs for Nickel and E2 would not be  fully additive);; the cost of fencing to 
avoid livestock access to water courses is es timated at between 2 and 12 €/ha/year (it 
is not possible to estimate how much fenci ng would be required in total, and at least 
some of the costs would fall under other legislation);   
o the possible costs, unko wn but not likely to be signifi cant, of substituting Quinoxyfen, 
if authorisation not anyway withdrawn unde r the PPP legislation; these could fall on 
the producers, formulators, farmers and/ or consumers depending upon the substitute; 
o approx 2-4 m € per annum to operate the watch-list. 
 
EN 60   EN Overall, the preferred options w ould achieve the most objectives with the greatest efficiency 
while ensuring coherence with  the existing legislation. 
5.8.3.  Distributional effects of the package of preferred options 
The most significant distributional effects of the preferred options can be summarised as 
follows.  However, it should be remembered th at there is uncertainty about how many effects 
would be in the baseline. Generic environmental and health benefits are not referred to here. 
Most of the distributional effects relate to the preferred substance option (A3c) rather than the 
options addressing the other gene ral objectives, although some rela ting to the latter are noted 
in the final bullet. 
• Sector-specific 
o Since several agricultural PPPs are include d in the preferred option, effects on PPP 
producers and formulators, and on farmers,  could be higher than in many other 
sectors, although many of the effects would be in the baseline anyway because of 
introduction of new requirements under the Sustainable Use of Pesticides Directive.  Effects relating to the producer  of Trifluralin (in HU, for export) and to the producer, 
formulators and users of Quinoxyfen could be  the most significant. Farmers could also 
bear costs associated with fencing waterc ourses to reduce E2 emissions (see above). 
On the other hand, farmers could benefit from improved ecosystem services. 
o The preferred substance option would invol ve including pharmaceuticals in the PS list 
for the first time, but none of the three pharmaceuticals is proposed as a PHS and no 
measures are proposed at EU level. Nevert heless, there could be an impact on the 
pharmaceutical sector in the long term if measures at MS le vel were taken to influence 
prescription and promote pha rmaceutical alternatives w ith lesser environmental 
impact. 
o The commercial fisheries and aquaculture sectors could be a ffected positively by 
improved water quality and fish health.  Th e introduction of an EQ S for Cypermethrin 
could require some salmon farmers to use alternative management methods to apply 
the substance or substitutes.  The introduction of an EQS for Cybutryne could lead to changes in maintenance practices for ship owners. 
o The commercial leisure sector (angling, boating) could be similarly affected. 
o The water sector (public and/or private) would be affected by any of the substance 
options because of the possible need to upgrade some UWWTPs to meet the EQS for 
substances discharged via this  route, in particular E2 and Nickel. Other substances 
would be impacted, e.g. DEHP, HBCDD. 
o The waste sector would likely have to addr ess end-of-life aspects of some products 
containing the proposed PS, e.g. HBCDD, and th ere might be implications (in relation 
to other substances too, e.g. PFOS, BDEs ) for the handling of landfill leachate.  
o There could be indirect impacts on the c onstruction sector from the requirement to 
meet an EQS for Terbutryn (although relevant  measures are unlikel y) and to phase out 
emissions of HBCDD to the aquatic environment.  
o 
Impacts in a number of other industry sectors would be expected to  be already in the 
baseline: e.g. energy generation and metal production (in relation to stricter EQS for 
PAHs in particular), transport (in relation to  the need to find a substitute for PFOS in 
aviation), textiles/polymers (in relation to BDEs, DEHP and HBCDD).  However, 
measures to meet the stricter EQS for Ni ckel could involve th e relevant industry 
sectors (e.g. alloys, metal plating, batteries , pigments, other chemicals, stainless steel 
production, mining). 
 
EN 61   EN o Impacts in the public sector w ould most obviously relate to monitoring cost s, but some 
public sector investment might be involved al so in infrastructure, in particular the 
upgrading of UWWTPs where these are in pub lic ownership (see above), possibly also 
in the context of landfill-site management. Sustainable Urban Drainage systems (SUDS) targeting urban run-off might also receive public investment but would also 
have other benefits (flood ri sk management). Although there might need to be some 
public investment in awaren ess-raising relevant  to pharmaceuticals prescription and 
disposal, spending on health care might  be reduced in the longer term. 
o Impacts on the public at large would likely include the passing on of any additional 
water treatment costs (urban and industrial waste water) or costs of cleaner energy, 
and the additional direct or indirect costs of  substitutes, if needed.  They could also 
include encouragement to change behaviour, e.g. in relation to th e disposal of unused 
pharmaceuticals. Significant impacts on em ployment in industry would not be 
expected (see producer  section below). Some employme nt opportunities might arise in 
sediment remediation and mechanical cleani ng as a substitute for biocidal coatings. 
• Producer and user-specific: 
o The overall impacts on producers are difficu lt to assess, because , despite extensive 
consultation, it has not been possible in many cases to determine who they are (therefore the size and resilien ce/capacity for diversificati on of the enterp rise, although 
most of those identified are large) or where production is located, even whether it 
occurs within the EU.  The production of so me substances (Dichl orvos, Heptachlor, 
PFOS) no longer occurs in the EU. Dichlo rvos and PFOS are manufactured in India 
and China, respectively and imported.  Ther e could be impacts on a producer (Israel-
based) of HBCDD in NL which employs approximately 90 workers in the production 
of brominated compounds, and a producer of Tr ifluralin (for export) in HU.  It is not 
clear whether Dicofol is still produced  in IT, nor whether the production of 
Quinoxyfen by a large US-based company o ccurs in the EU.  Cybutryne may be 
produced in CH by a large DE-based compa ny; Terbutryn production occurs in part 
outside the EU. It should be remembered th at most substitution costs, including those 
relating to employment, w ould be in the baseline. 
o There could be impacts on formulators of  some PPPs and biocides, including the 
formulators of biocidal coatings, since th ere are EU formulators for most of these 
substances and they are not necessarily rest ricted to the MS where the substances are 
used.  However, other (existin g and/or new) products would be likely to take the place 
of substances whose use had to decrease or cease, and these could in theory be 
handled by the same formulators. 
o Impacts on the users of the products/formulations could occur as described for the 
sectors in the first main bullet. 
• MS- and region-specific 
o The possible geographical impacts on producer s and formulators are covered under the 
previous point. An additional observation is  that trade (import, export) with third 
countries is unlikely to be affected si gnificantly beyond the baseline for most 
substances.  This is because, of the substances known to be relevant, i.e. proposed 
PHS that are currently imported into the EU  or manufactured in the EU for export, 
most (DEHP, Dicofol, HBCDD, Heptachlor, PFOS, Trifluralin) are already and/or are 
expected to be further re stricted under the baseline . An exception could be 
Quinoxyfen, depending upon where it is manuf actured (information not available). 
 
EN 62   EN o Regulation of the PPPs would most likely affect all MS, but to  different extents 
influenced by factors including crop type  and value, production area, and production 
intensity. The MS with the largest use of  agricultural PPPs are FR, IT, ES, DE, UK, 
PT; those with the most intense use are BE  and NL (EC, 2006), an d this list could be 
indicative of the MS that w ould likely be among the most affected by the preferred 
substance option, which includes several PPPs. Indeed, FR is noted to have the largest 
consumption of two of the PPPs, i.e. Acl onifen and Bifenox, and is also among the 
highest users of Quinoxyfen and Cypermethr in. As indicated above, formulators of 
PPPs are not necessarily restricted to the MS  where they are used  or authorised. The 
data obtained did not allow the degree of co rrelation to be determined. However, for 
the above four PPPs, the information obtained showed that the number of products containing these substances was higher in FR  than in other MS, and since all four 
substances are in the preferred package, FR  could be more affected than some other 
MS. The picture is less clear for many of  the MS partly because, despite the 
widespread authorisation of  these substances, few MS provided monitoring data, and 
the prioritisation of two of the substances  was based primarily on modelling (taking 
account of use). Even in MS like FR, the e ffects would be limited, however, since only 
one substance is proposed as a PHS, most of the costs (e.g. of implementing buffer 
strips) are likely to be in the baseline, and larger farm ing and PPP (formulation and 
use) sectors are likely to be  able to handle any need to decrease or cease emissions.  
o In relation to the inclusion of pharmaceutical s, the effects on authorities (monitoring 
obligation initially); and in due course also  on patients and medi cal professionals (in 
relation to take-back schemes and prescription practice) could be greater in some MS 
than others, depending upon their per capita consumption of the pharmaceuticals.  For 
example, DE would likely be more affected than ES, because per capita consumption of Diclofenac is several-fold higher.  Like wise, effects in MS with lower per capita 
consumption of the contraceptive pill (e.g. EL, PL) would be less. 
o Impacts in relation to certain substances  could be more noticeable in MS with 
extensive coastlines, and significant dockyards, that have not already restricted the use 
of Cybutryne, and possibly in MS with more  aquaculture (specifi cally salmon farming, 
i.e. in IE, UK, (NO) if using Cypermethrin). 
o Impacts related to substances present signi ficantly in urban waste water discharges 
(e.g. BDE, DEHP, HBCDD, Ni, PFOS, pharm aceuticals), would be likely to be felt 
mainly in MS with higher population densit y and lower water resources (smaller water 
courses) (especially UK, NL and parts of  DE); these substances are distributed 
throughout the substance options. 
o Sub-regional impacts might be seen in relation to Nickel (as a result of effects of local 
conditions on bioavailability), E2 (because of differences in the exte nt and intensity of 
livestock farming as well as conurbations) and PAHs (according to the influence of 
natural sources and conditions). 
o The positive impact of the option to flexib ly present the results of monitoring 
ubiquitous PBTs should by definition bene fit all MS.  The other preferred non-
substance options should also benefit all MS though those with a tradition of 
monitoring only in water could face more ad aptation costs.  All MS would benefit 
from the possibility provided by the watch list to improve the prioritisation process 
and thus ensure that long-term EU-wide oblig ations are introduced  only for substances 
most relevant at that level. 
In conclusion, the preferred options do not a ppear to have significan t unfair distributional 
impacts when the baseline is taken into account. 
 
EN 63   EN 5.8.4.  Approach to translating the options  into a legislative proposal 
The options above would be implemented by amending the EQSD  2008/105/EC and WFD 
Annex X. 
6. MONITORING AND EVALUATION  
The WFD contains built-in monitoring and evalua tion processes.  Regular monitoring of the 
environmental concentrations of the PS and PHS is foreseen in the Directive. MS report every six years (as part of the Ri ver Basin Management Plan) on chemical status and their 
programmes of measures. In addition, MS report monitoring data annually to the EEA as part 
of the State of the Environment reporting. 
In addition, the implementation of the WFD in  accordance with the Common Implementation 
Strategy, involving as it does working groups such as the WG E on Chemical Aspects, allows 
the Commission to obtain informal oral and wri tten feedback from MS on the implementation 
and effectiveness of the Direct ive and of any relevant measures.  Feedback can also be 
obtained from other stakeholder groups on the wider impacts of the legislation, and this would 
be done during the course of the ne xt review due in four years. 
 
EN 64   EN ANNEX I: Glossary / List of acronyms  
AA-EQS  Annual Average EQS 
BDE  Brominated Diphenylether CIS  Common Implementation Strategy for the Water Framework Directive 
CMEP  Chemical Monitoring and Em erging Pollutants Sub-group of WGE 
COMMPS Combined Monitoring and Modelling-based Prioritisation 
CSTEE Scientific Committee on Toxic ity, Ecotoxicity and the Environment 
DEHP  Bis(2-ethyl hexyl)phthalate 
DL-PCB Dioxin-like Po lychlorinated biphenyl 
DOC  Dissolved Organic Carbon E2  17 beta-estradiol EE2 17 alpha-ethinylestradiol EEA European Environment Agency EFPIA European Federation of Pharm aceutical Industries and Associations 
EQS Environmental Quality Sta ndard, i.e. the concentration of a particular pollutant 
or group of pollutants in water, sedi ment or biota which should not be 
exceeded in order to protect human heal th and the environment (WFD Article 
2.35) 
EQSD Environmental Qualit y Standards Directive (Dir ective 2008/105/EC of the 
European Parliament and the Council on environmental quality standards in the 
field of water policy) 
GAC Granular Activated Carbon (tertiary water treatment) 
HBCDD Hexabromocyclododecane HELCOM Helsinki Convention for the protection of the Baltic Sea 
HRT  Hormone Replacement Therapy ICPDR  International Convention for the Protection of the Danube River IPPC Integrated Pollution Prevention and Control Directive (D irective 2008/1/EC of 
the European Parliament and of th e Council of 15 January 2008 concerning 
integrated pollution prevention and control) 
JRC  Joint Research Centre of the European Commission 
 
EN 65   EN MAC-EQS Maximum Allowable Concentration EQS 
MS  Member State(s) NAP  National Action Plan NSAID Non-steroidal Anti-inflammatory Drug OSPAR Oslo-Paris Convention for the protection of the North Sea 
PBT  Persistent Bioaccumulative and Toxic PCB  Polychlorinated biphenyl PHS  Priority Hazardous Substance under the Water Framework Directive 
Poly-BDE Poly-Brominated Diphenyl Ethers POP  Persistent Organic Polluta nts under the Stockholm Convention 
PPP  Plant Protection Product PS  Priority Substance under the Water Framework Directive RAR  Risk Assessment Report RBD  River Basin District RBMP River Basin Management Plan under the Water Framework Directive 
RBSP River Basin Specific Pollutant REACH Regulation (EC) No 1907/2006 of the Eu ropean Parliament and of the Council 
of 18 December 2006 concerning the Re gistration, Evaluati on, Authorisation 
and Restriction of Chemicals (REACH)  
SCTEE = CSTEE SME Small and medium-sized enterprises SVHC  Substance of Very High Concern TGD-EQS Technical Guidance Document fo r deriving EQS (European Commission, 
2011b) 
UWWTD Urban Waste Water Treatment Direc tive (Council Directive 91/271/EEC of 21 
May 1991 concerning urban waste-water treatment) 
UWWTP Urban Waste Water Treatment Plant WFD Water Framework Directiv e (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) 
 
EN 66   EN WG E Working Group E on Chemical Aspect s (under the Strategic Coordination 
Group for the Common Implementation Strategy of the WFD) 
WISE  Water Information System for Europe ( http://water.europa.eu )  
 
 
EN 67   EN ANNEX II: Summary of the prioritisation  process and the establishment of EQS  
This annex summarises the main criteria for the identification of priority  substances (PS) and 
the results of the technical work done to review  existing PS (EQS and PHS status), to identify 
new P(H)S and to set EQS for them. 
Criteria for the identification of PS  
According to WFD Article 16(2) PS should be id entified among those causing a risk to or via 
the aquatic environment, by means of 
a. Risk assessment carried out under the chemical s, PPP and biocides legislation (Regulation 
(EEC) No.793/93, Directive 91/414/EEC a nd Directive 98/8/EC respectively) 
b. Targeted risk assessments focusing on aquati c ecotoxicity and on human toxicity via the 
aquatic environment 
c. Simplified risk-based assessment procedure base d on scientific principles taking particular 
account of  
i. Evidence regarding the intrinsic hazard of the substances,  
ii. Evidence from monitoring of widespread contamination 
iii. Other factors that may indicate widesp read contamination such as production 
volumes and use patterns 
Some of the above points make particularly cl ear the importance of considering the route of 
exposure, i.e. substances identified as PS/PH S must be relevant to or via the aquatic 
environment, not other environmental compartments alone. 
Summary of the prioritisati on exercise and its results  
The first list of 33 PS was es tablished by Decision 2455/200138 in 2001 (effectively Annex X 
of the WFD).  
At the time the first list was identified, very few risk assessment were available under the 
chemicals, PPP and biocides le gislation. The COMMPS procedure39 was developed as a 
simplified risk-based assessment that combined  the available information on the intrinsic 
hazard of substances (point c.(i) above) with estimates of  exposure based on monitoring 
information (point c.(ii) above) and modelli ng information derived from production volumes 
and use patterns (point c.(iii) above). 
In view of the large number of potentially harmful substances, it was necessary in the current 
review, as for the first list, to conduct a priori tisation process to identi fy those most likely to 
cause harm to or via the aqua tic environment. The prioritis ation process was based on the 
criteria set out in the WFD Artic le 16(2) (see above), taking a ccount of the experience gained 
with the COMMPS procedur e used to establish th e first list. An opinion40 on that procedure 
                                                 
38  OJ L3331, p 1, 15.12.2001 
39  Combined monitoring-based and modelling-based priority setting, developed for the first prioritisation 
exercise:  http://ec.europa.eu/environment/water/water-dangersub/lib_pri_substances.htm   
40  Opinion on the revised proposal for a List of Priority Substances in the Context of the Water 
Framework Directive (COMMPS Proc edure) prepared by the Fraunh ofer-Institut (Germany) - Final 
 
EN 68   EN from the Scientific Committee on Toxicity, Ec otoxicity and the Environment (CSTEE), and 
discussions among Commission servi ces, MS and stakeholder expert s, were considered in the 
development by WG E of an improved methodology. 
A combination of different approaches was consider ed best to identify candidates for the list.  
Each of the approaches in WFD Article 16(2) was pursued in parallel.  The simplified risk-
based assessment used outputs from extensiv e monitoring and modelling exercises. In the 
context of considering assessments under othe r legislation, attentio n was also given to 
Substances of Very High Concern (SVHCs) un der REACH, and substances of concern under 
the Convention on Persistent Organic Pollutants (P OPs).  Substances of concern at MS level 
were also examined, as well as the substances identified in Annex III of the EQS Directive.  
The parallel prioritisation pro cesses, which were subject to ex pert review in the Sub-Group on 
Review, led to separate but complementary list s of substances.  The lists or at least the 
highest-priority substances on each list were amalgamated and subjected to a short-listing procedure.  The range of processes took advantag e of the most relevant available information.  
Inevitably there was some overlap between the lists, despite th e independence of the 
processes, and this made the case for prioriti sing some substances particularly strong. The 
individual prioritisati on processes and the short-listing pr ocedure were followed by further 
shortlisting on the basis of detailed dossiers prepared by the Commi ssion and MS experts. 
Because the implementation of the legislation on  chemicals, PPP and biocides has progressed 
substantially since the previous  prioritisation, it was possible to refer to many more risk 
assessments under those other pieces of legisla tion, including some in draft stage and others 
prepared on a voluntary basis. 
Particular attention was paid to the risk ratio for each substance, i.e. the measured 
environmental concentration divided by the pred icted no-effect concentration, and to evidence 
of persistence or bioaccumulation. The status of the substances was considered on the basis of information relating to the criteria for substanc es of very high concern in Article 57 of the 
REACH Regulation, for example the PBT and very  Persistent very Bioaccumulative (vPvB) 
criteria, in association with information on exposure of and via the aquatic environment. 
Existing substances (EQS and PHS status) were re viewed on the basis of revised or finalised 
risk assessment reports and d ecisions made under other legisl ation. Consideration was given 
to observations from MS rega rding analytical difficulties. 
In setting the EQS, use was made of the revised Technical Guidance Document on the 
Derivation of Environmental Quality Stan dards, which provided improved scope for 
considering the setting of standards in biota and/or sediment where relevant, as compared 
with the 2005 version that was used for the setting of the EQS for the first list of PS. 
Further details of the techni cal process are provided in Commission Staff Working Paper 
SEC(2011)1544 (European Commission 2011). 
The conclusions of the prioritisation process were  that the substances listed in the table below 
pose a risk to or via the aquatic environment for the reasons indicated, and that there are 
                                                                                                                                                        
 
report Opinion adopted at the 11th CSTEE plen ary meeting on the 28th of September 1999. 
http://ec.europa.eu/health/ph_risk/committees/sct/docshtml/sct_out49_en.htm   
 
EN 69   EN therefore technical grounds for regulating them  under the WFD. (See also Annex V for more 
information on the substances.)  
 
CAS# Substance Main reasons for pr ioritisation as PS (or PHS) 
57-63-6 17 alpha-
ethinylestradiol Endocrine disruptive; risk ratio >1 
50-28-2 17 beta-estradiol Endocrine disruptive; risk ratio >1 
74070-46-5 Aclonifen Ranked high in modelling based pr ioritisation; bioaccumulative and 
toxic (and some evidence of persistence); risk ratio >1 
42576-02-3 Bifenox Ranked high in modelling based prioritisation, very toxic, risk ratio >1 
28159-98-0 Cybutryne (Irgarol®) 
 Substance of concern in MS, toxic, risk ratio >1; degrades only slowly; 
main degradation product (M1) also toxic; persists in sediments. 
52315-07-8 Cypermethrin 
 Ranked very high in monitoring-based prioritisation and high in 
modelling-based prioritisation; very toxic; risk ratio >1 
62-73-7 Dichlorvos Ranked very high in monitoring-based prioritisation, medium in 
modelling-based prioritisation, risk ratio >1; possibly carcinogenic to humans (IARC 2B, Carc. Cat. 3 probable under Dangerous Substances 
Directive); potential for local mutagenicity. 
15307-79-6 Diclofenac Toxic; risk ratio >1 
115-32-2 Dicofol Annex III substance; ranked high in monitoring and in modelling based 
prioritisation, risk ratio >1; recommended for designation as POP 
(Stockholm Convention); possibly carcinogenic to humans, possibly 
endocrine disruptive; organochlorine PPP, similar to DDT.  
1746-01-6 Dioxins (and dioxin-
like PCBs) Annex III substances. POPs (Stockholm Convention and CLRTAP). 
PBT properties. Ranked very high in  monitoring-based prioritisation; 
some congeners probably carcinogenic to humans, possibly endocrine 
disruptive. 
3194-55-6 / 25637-99-4 HBCDD Ranked high in modelling-based prioritisation; PBT, SVHC under 
REACH, recommended POP, EU RAR conclusion of risk to aquatic 
environment. 
76-44-8/ 
1024-57-3 Heptachlor/Heptachlor 
epoxide Ranked very high in monitoring -based prioritisation; POP (Stockholm 
Convention); very toxic to aquatic organisms; risk ratio >1; possibly/probably carcinogenic to humans, possibly endocrine 
disruptive. 
1763-23-1 PFOS Annex III substance, PBT, POP, risk ratio >1 
124495-18-7 Quinoxyfen PBT and vPvB properties 
886-50-0 Terbutryn Ranked high in modelling based prioritisation, medium in monitoring-
based prioritisation, toxic, risk ratio >1 
 
The conclusions of the assessment of new t echnical information re garding existing PS are 
presented in the table below.  (See also Annex V for more information on the substances.) For 
other existing substances, there was either no ne w risk assessment repor t or no grounds within 
such a report to make a (signi ficant) change to the EQS or a change to the status of the 
substance. 
 
PS 
no# Substance Rationale for review/nature of change 
2 Anthracene Review of the EQSs prompted by revised RAR for pitch.  Conclusion that high 
acute toxicity justifies setting MAC equal to AA-EQS. 
 
EN 70   EN PS 
no# Substance Rationale for review/nature of change 
5 Poly (including octa) 
BDE Modelling-based prioritisation identified octa BDE (BDE-197) as a priority.  
EQS for the group of BDEs (hitherto for penta BDE (CAS 32534-81-9)) 
therefore reviewed to cover octabromo BDE (CAS 32536-52-0) and take account 
of new information.  However, proposed EQS (more stringent than before) based on BDE 99 (penta derivative). Extension of PHS status to octa BDE on grounds 
of PBT properties 
12 DEHP Reprotoxic Cat 1B (Reg (EC) No 1272/2008), in Annex XIV of REACH (since 
2011), EU RAR (2008) 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 reductio n measures). Change status to PHS. 
15 Fluoranthene Review of the EQSs prompted by revised RAR for pitch. Conclusion that biota 
EQS is critical EQS.  Corresponding water EQS much more stringent than 
existing EQS.  MAC also more stringent. 
20 Lead EU VRAR 2008, SCHER review of VRAR 2009, first draft of Chemical Safety 
Report for REACH registration, and need to consider bioavailability.  Review of 
EQS promised at time of 2006 Commission proposal.  EQS bioavailable  now 
proposed. 
22 Naphthalene   Review of the EQSs prompted by revised RAR for pitch. Conclusion that need 
slightly more stringent EQS for fr eshwater and introduction of MAC. 
23 Nickel 
 New information (EU RAR 2008, SCHE R review of RAR 2009, additional 
industry studies related to REACH registration), and need to consider 
bioavailability. Review of EQS promised at time of 2006 Commission proposal.  EQS 
bioavailable  now proposed. 
28 PAHs 
Benzo(a)pyrene 
Benzo(b)fluoranthene Benzo(k)fluoranthene 
Indeno(1,2,3-
cd)pyrene 
Benzo(g,h,i)perylene Review of the EQSs prompted by revised RAR for pitch. 
Conclusions: Biota EQS is critical EQ S for all but Benzo(g,h,i)perylene.  
Corresponding water EQS more stringent than existing EQS.  Introduction of MAC for three PAHs; slightly changed MAC for Benzo(a)pyrene. Revised EQS 
for Benzo(g,h,i)perylene slightly less stri ngent in freshwater, more stringent in 
saltwater. 
33 Trifluralin 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.) 
 
The revision and derivation of EQS  
EQS for the first list of PS were set in th e Environmental Quality Standards Directive 
(2008/105/EC) 41 in 2008.  The rationale for the EQS Directive is well explained in the 
Commission Communication (COM (2006) 397 final) that accompanied the Commission 
proposal42. 
A guidance document was used to set standards for the first list of PS43. Standards were set 
only in water, except for three substances (mercury and its compounds, hexachlorobenzene and hexachlorobutadiene) for which they were set in biota, with the proviso that if MS chose 
to use a water standard it should  be equally protective.  According to Article 3(2) of the EQS 
Directive, MS may opt to apply EQS for sediment  and/or biota instead of the water standards 
                                                
 
41  OJ L348, p.84-97, 24.12.2008 
42  http://eur-lex.europa.eu/LexUriServ/Le xUriServ.do?uri=C ELEX:52006DC0398:EN:NOT   
43  Lepper, 2005.  
 
EN 71   EN in the Directive but they  too should offer at least the same le vel of protection as the prescribed 
water standards. 
The 2005 guidance has been revised44 and substantially expanded to update to the latest 
scientific and technical knowledge. The new gui dance, which received a generally favourable 
opinion from the SCHER in 2010 has been used to update EQS for existing substances, derive EQS for other matrices than water, and derive  EQS for the newly identified substances. The 
following tables present the updated and derive d standards for existing and new substances. 
Proposed changes to EQS a nd status for existing PS: 
# Substance Proposed AA-QS 
water 
µg/l (Existing)  Proposed MAC-
QS water 
µg/l (Existing) Proposed Biota 
EQS 
µg/kg ww Change 
to PHS? 
2 Anthracene  0.1 (0.4)   
5 Poly (including octa) 
BDE  F  4.9 10-8 (0.0005) 
S  2.4 10-9 (0.0002) F  0.14 (na) 
S  0.014 (na) 0.0085  
12 DEHP    Yes 
15 Fluoranthene 6.3 10-3 (0.1) 0.12 (1.0) 30   
20 Lead F  1.2 bioavailable  (7.2) 
S  1.3 bioavailable  (7.2) F  14.25 (na) 
S  14.25 (na) 
   
22 Naphthalene   F  2.0 (2.4) 
S  2.0 (1.2) 130 (na) 
130 (na)   
23 Nickel 
 F  4 bioavailable  (20) 
S  8.6 bioavailable  (20) F  34 
S  34   
28 PAHs      
 Benzo(a)pyrene 1.7 10-4 (0.05) F  0.27 (0.1) 
S  0.027 (0.1) 
 Benzo(b)fluoranthene 1.7 10-4 (0.03*) F  0.017 (na) 
S  0.017 (na) 
 Benzo(k)fluoranthene 1.7 10-4 (0.03*) F  0.017 (na) 
S  0.017 (na) 
 Indeno(1,2,3-cd)pyrene 1.7 10-4 (0.002**)  Benzo(a)pyrene as 
marker 
2 for fish 
5 for crustaceans 
and cephalopods 
10 for molluscs 
 Benzo(g,h,i)perylene F  8.2 10-3 
S  8.2 10-4 
(0.002**) F  8.2 10-3 (na) 
S  8.2 10-4 (na)   
33 Trifluralin    Yes 
Notes to the table: 
− PHS means priority hazardous substance 
− F means freshwater 
− S means other surface waters 
− Eco means the standard is set for protection of ecology 
− If not specified the standards apply to both freshwater and other surface waters. 
− (na) means not available 
− If left blank means no standard or no change to standard or status proposed 
− The existing standards for the two PAH marked wi th (*) and the two marked as (**) are given in 
Directive 2008/105/EC as the sum of the two compounds. 
− For the PAHs, the AA-QS water of 1.7 10-4 µg/l corresponds to the biota EQS and benzo(a)pyrene 
can similarly apply as a marker for all five PAHs. 
 
Proposed EQS and PHS status for newly identified substances: 
                                                 
44  European Commission, 2011b 
 
EN 72   EN Substance Proposed AA-QS 
water 
µg/l Proposed MAC-
QS water 
µg/l  Proposed Biota 
EQS 
µg/kg ww PHS? 
Dicofol F  1.3 10-3 
S  3.2 10-5  33 Yes 
PFOS F  0.00065  
S  0.00013 F  36 
S  7.2 9.1 Yes 
Quinoxyfen (tbc) F  0.15  
S  0.015 F  2.7  
S  0.54  Yes 
Dioxin   Sum of 
PCDD+PCDF+PCB-DL 
8.0 10-3 µg.kg-1 TEQ Yes 
Aclonifen F  0.12  
S  0.012  F  0.12  
S  0.012   No 
Bifenox F  1.25 10-2  
S  1.25 10-3  F  0.04 
S  0.004   No 
Cybutryne 0.0025  0.016    No 
Cypermethrin F  8.2 10-5 
S  8.2 10-6 F  5.8 10-4 
S  5.8 10-5  No 
Dichlorvos F  6 10-4  
S  6 10-5  F  7 10-4  
S  7 10-5   No 
HBCDD F  1.6 10-3 
S  0.8 10-3 F  0.52 
S  0.052 167 Yes 
Heptachlor/ heptachlor 
epoxide F  2.1 10-7 
S  1.0 10-8 F  3 10-4 
S  3 10-5 6.7 10-3  Yes 
Terbutryn F  0.065 
S  0.0065 F  0.34 
S  0.034  No 
17alpha-ethinylestradiol  F  3.5 10-5   
S  7 10-6   No 
17beta-estradiol   F  4 10-4 
S  8 10-5   No 
Diclofenac F  0.10 
S  0.01   No 
− If left blank means no standard proposed 
− TEQ means toxic equivalents 
 
EN 73   EN ANNEX III: Background and details regarding  ubiquitous PBTs and knowledge base 
(watch list) options  
Ubiquitous PBTs 
Presentational issues Many measures have already been taken to redu ce or eliminate emissions of these substances, 
and there is little more, if anything, that can be  done from the water management perspective 
to improve the situation, other than plug outstanding implementation gaps or attempt remediation (if technically and economically feas ible) of highly contaminated "hotspots". For 
some substances, additional measures might stil l be possible in other policy areas, e.g. those 
dealing with diffuse or air emissions, but the pe rsistence of the substances means that it may 
take many years – thus well beyond a RBMP cycle - for any of the measures (other than remediation) to have an impact on the levels in  the aquatic environment, which in many cases 
are a legacy of past use or the uninte nded consequences of human activities. 
The WFD (Article 4) and the EQSD (Article 6)  contain exemption mechanisms that could be 
used by MS to justify not meeting the EQS, i. e. on the grounds that doing so would not be 
technically feasible or would entail disproportionate costs, that the achievement of the 
objectives will take longer than the WFD timelin es due to natural conditions, or that the 
pollution has a transboundary orig in.  However, these exemptions would need to be used 
widely, and the improvements made in relation to  other substances would be hidden.  Indeed, 
waters are assessed in the WF D for their overall chemical st atus against all the EQS and 
therefore a bad situation for some chemicals (i n this case PBTs) could blur even a rather 
positive situation for other substances. The "maps" used for reporting of chemical status would then be dominated by failures. 
Since the outcome of the current review could add several ubiquitous PBTs to the PS list, and 
since some of those already id entified in 2001 could be subject to more stringent EQS, it is 
likely that the failure rate would increase. Theoretically, given th at the possible new PS 
referred to here are ubiquitous a nd often present in concentrations higher than the no-effect 
levels, MS should have identified them as  RBSPs under the WFD and an EQS should have 
been set at national level. Howeve r, this has happened only rarely  (see table in Annex V) and, 
as a consequence, listing these substances as PS could indeed have a significant impact on the 
chemical status.  
Choice of monitoring matrix 
The EQSD, in its final form as agreed by the legislator, includes the flexibility for MS to 
choose the matrix to monitor th e PS. EQS for water are given in Annex I of the EQSD, but 
MS can choose to develop and use sediment and/or  biota standards that offer at least the same 
level of protection as those provided for water. The exception to this is the case of three 
substances (Mercury, Hexachlorobenzene and He xachlorobutadiene), for which EQS for biota 
are given in the EQSD
45 that MS have to use unless they develop and apply a water standard 
                                                 
45  These substances are hydrop hobic and bioaccumulative and ther efore the preferred matrix for 
monitoring is biota; their concentrations in water are so low that are rarely meas urable using state of the 
art analytical techniques. The main exposure route ca using risk is secondary poisoning, i.e. risks to 
human health via ingestion of contaminated fish or shellfish. 
 
EN 74   EN that offers the same level of protection as th e biota standard (hence the water standards in 
Annex I are never used for these three substances). 
Knowledge and methodologies to develop EQ S for sediment and biota have evolved 
significantly, and it is now possible to derive  standards for these matrices (SCHER, 2010). 
However, this expertise is not available in all MS. For example, the  Sub-Group on Review 
(which worked on the prioritisation and EQ S derivation) received significant input from 
around one third of the EU MS, all from the EU15. The information in the first RBMP shows that, except in a few Member St ates, the number of national or  river basin standards set by 
Member States is very limited, demonstrati ng the limited experience of many MS at deriving 
EQS. In addition, from a MS survey done in 2011, only 5 MS have indicated they might use 
the flexibility in the EQSD to derive their own standards for sedime nt and/or biota for 
substances other than the three for which such standards are provided at  EU level. The biota 
standards for these three, though, are used by al most all MS (19 out of the 20 who responded). 
This demonstrates a preference for using the EU  standard, probably because it is seen as 
robust but also because its provision eliminates the need for MS to derive a national (equally 
protective) water standard.  
Most of the ubiquitous PBTs are very hydrophobic. It  is therefore difficult to monitor them in 
water. The analytical techniques available ar e rarely sensitive enough to reliably detect 
concentrations of the order of the EQS, as the EQS is itself very close to (or below) the limit 
of determination. This means that where the re sults of an analysis are below the limit of 
determination, the concentration in the sample may still be higher than  the EQS. Commission 
Directive 2009/90/EC requires MS to use analyt ical techniques that meet certain minimum 
quality requirements in relation to the EQS, but  it also establishes that if the analytical 
techniques don't meet those mi nimum criteria, the best ava ilable techniques not entailing 
excessive costs should be used. Because of this  clause, some MS are applying water standards 
for certain substances even though they are not ab le to monitor at the level of that EQS. The 
fact that PBTs tend to accumulate in sediment  and biota means that th eir concentrations are 
likely to be higher in those matr ices than in water. The analytical methods are therefore more 
likely to be adequate, and more likely to dem onstrate exceedance of the EQS established for 
those matrices. MS which apply a water EQS set at a level below the limit of determination of 
the analytical technique might therefore conclude that "there is no problem", even though the 
application of a sediment or biota standard might reveal extensive failure. Although legally 
possible within the current legislative set-up, it  is clearly unacceptable that water bodies are 
categorised as having "good chemi cal status" while they contain elevated values in sediment 
and/or biota that pose a risk to or via the aquatic environment. 
The assessments of chemical status reported  by MS in their first RBMPs illustrate the 
problem. For example, in one MS using the biota standard for Mercury, 100% of surface 
water bodies fail to achieve good chemical stat us. A neighbouring country, which suffers the 
same problem of widespread Mercury pollution by atmospheric deposition, monitors in water 
and reports a failure rate of only 0.4%. Althou gh it is not clear whethe r the latter country's 
EQS is equally protective, the fact is that a very similar environmental situation is assessed and reported in a very different way due to the choice of matrix.  Another MS that had orally 
indicated widespread failure of  the Mercury standard in biot a has reported in the RBMPs a 
failure rate based on a water standard of only 8.4%.  
Monitoring effort 
 
EN 75   EN An additional issue that has been raised by MS in relation to these substances is the 
monitoring requirements. The WFD (Annex V) se ts minimum monitoring requirements which 
are adapted to the RBMP cycle. They aim at: 
o providing a general assessment of the status of waters in the basin (surveillance 
monitoring - monthly frequency during one  year within the 6-year cycle),  
o establishing the status of th e water bodies with a suffici ent level of confidence and 
measuring the improvements resulting from the programmes of measures (operational 
monitoring (guideline) - monthly frequenc y throughout the cycle as a guideline).  
The EQSD prescribes a minimum frequency for compliance monitoring of sediment and/or 
biota of once every year and for trend assessm ent once every three years. The WFD and the 
EQSD allow for reduced frequency if justified on the basis of technical knowledge and expert 
judgement. For ubiquitous PBTs, any change in  environmental concentrations that might 
occur as a result of measures is likely to occur over the long term (unless remediation is 
carried out) and therefore a lower monitoring fr equency would seem justified. A reduction in 
the number of monitoring sites might also be re asonable.  If MS choose to use a sediment or 
biota standard, the default monitoring freque ncy is already lower (annually rather than 
monthly).  The issue is how, for ubiquitous PB Ts, the monitoring frequency can be optimised 
to minimise the administrative burden wh ile still yielding sufficient information. 
Knowledge base 
Emerging pollutants The NORMAN network
46 defines emerging polluta nts as: "pollutants th at are currently not 
included in routine monitoring programmes at  the European level and which may be 
candidates for future regulation, depending on res earch on their (eco)toxi city, potential health 
effects and public perception and on monitoring data regarding th eir occurrence in the various 
environmental compartments".  In additi on, there are many unregulated "emerging 
substances" which have been detected in th e environment but whose fate, behaviour and 
effects are not yet well enough understood for them to be necessarily regarded as pollutants.  
The NORMAN database of these emerging po llutants and emerging substances numbers 
some 750 substances. 
Watch list technical deta ils and structural support 
The technical elements of the proposed watch list would be as follows: 
• Selection of the substances to monitor (around 20±5) in accordance with the following 
criteria: 
− (Emerging) pollutants for which there is evidence from the information available 
(e.g. from research and MS monitoring or  studies, and taking into account use 
patterns and available monitoring and ecot oxicological data) th at they may pose a 
risk to or via the aquatic environment at EU level, but for which there are insufficient data or insufficiently hi gh-quality data to assess the risk 
                                                
 
46  The NORMAN network started its activities in Se ptember 2005 with the financial support of the 
European Commission (NORMAN project - 6th Framework Programme) and it is now established as a permanent self-sustaining network of more than 50 reference laboratories, research centres and related 
organisations for the monitoring and biomonitoring of emerging environmental substances. 
http://www.norman-network.net/
  
 
EN 76   EN • Development of guidelines (substanc e-specific, if appropriate) on:  
− selecting representative st ations (250-300 across the EU ) (to be selected by MS) 
− sampling methods and/or periods  
− the monitoring matrix/matrices (w ater, sediment and/or biota) 
− the minimum number of samples (1-5, average of 2, per year per station) 
− the analytical methods and/or minimum performance criteria  
− any other technical needs to de liver a high quality dataset.  
 
Existing structures would be used for the techni cal work and for data collection. In particular, 
the technical work would be done using the ex isting informal structures of the WFD Common 
Implementation Strategy (CIS), in particul ar the WG E and its sub-group on Chemical 
Monitoring and Emerging Pollutants (CMEP), co-chaired by the JRC. Experts from MS, 
stakeholders and the Commission are represen ted and they have the experience and the 
expertise for this task. Other options such as establishing a new group have been considered but seemed superfluous and inefficient in co mparison. Data collection would be done using 
the Water Information System for Europe (W ISE) managed by the EEA - an already a well-
established EU system for collecting water data. Alternative optio ns considered (e.g. 
establishing an ad-hoc system for reporting)  would likely be more  expensive and less 
effective.  The additional monitoring involved, which woul d be done by MS, would be limited. Current 
water-related monitoring requirements are alre ady quite substantial across the EU, not only 
for the WFD PS (estimated cost ca. 69 million Euros annually, see Annex IV) but also for 
other WFD obligations (ecologica l status), other Water Directiv es (Bathing Water, Nitrates, 
Urban Waste Water) and other water-related in ternational commitments (OSPAR, HELCOM, 
Barcelona Convention, Rhine Commission, ICPDR,  etc). The proposal fo r the watch list to 
have 20±5 substances monitored at 250-300 stat ions is considered reasonable noting that: 
− For each substance on the watch list a mi nimum of information would need to be 
gathered (available monitoring data, ecotoxi cological information, use patterns, etc). 
This would imply additional work for the WG E and the CMEP sub-group. The 
proposal is consistent with the amount of work that the existing groups can handle 
without increasing significantl y the administrative costs. 
− There is a pragmatic limit on how many substa nces can be considered in detail for 
prioritisation in each of the regular review s of the PS list. In the current review, the 
prioritisation process arrived at  a short-list of 41 substances  for detailed consideration, 
and in 15 substances being proposed for addition to the list (the subject of options A3a-A3c above). This has been used as a guideline : a watch list of 20 s ubstances renewed on 
average every two years would provide mon itoring data on about 40 substances every 4 
years. This would provide substantial and pr obably sufficient input for the objective of 
the regular review of the PS., especially in view of the othe r possible sources of 
information including the data on RBSPs. 
− There are 110 RBDs in the EU, 176 if each nati onal part is consider ed separately. The 
figure of 250-300 stations woul d provide for at least one st ation per RBD and more in 
the case of large RBDs. This woul d provide an EU-wide picture. 
 
To ensure that the watch list served its purpose and was as cost-effective as possible, it would 
be updated regularly and the resu lts subjected to expert scruti ny. If one year of monitoring 
showed that there was no significant risk at EU level, the relevant substance could be 
removed.  There would be annual electronic reporting to WISE, and the data would be 
analysed by the experts of the WG E/CMEP sub-group. If  the information were not 
 
EN 77   EN conclusive after a year, the subs tance would be kept on the watc h list. If the information were 
considered sufficient for risk assessment pur poses, the substance would be replaced by 
another. It is estimated that on average the s ubstances would remain on the list for 2 years. 
 
 
EN 78   EN ANNEX IV: Approach to the assessment of impacts  
 
Assessment of impacts arising from  regulation of the substances 
According to the provisions of the WFD and EQSD, the review addressed the following 
issues: 
(i) Determine whether additional substances shoul d be identified as PS or PHS and if so, 
to establish the appropriate EQS for each subs tance in water, sediment and/or biota. 
(ii) In relation to existing PS and PHS and considering any new technical/scientific 
information: 
– review the existing EQS 
– establish, if appropriate, EQS for sediment and/or biota 
– review the PHS classification  
(iii) Consider the need for control measures for both existing and newly identified PS and 
PHS (according to Article 16(6) of the WFD and Article 7 of EQSD). 
In relation to (i) and (ii) above, the choice of ma trix (i.e. water, sediment and/or biota), and 
the determination of the EQS, ar e largely scientific/technical de cisions that take account of 
the behaviour of a particular substance in the environment and the availability of relevant 
scientific information.   There ar e also established criteria for identifying PS as PHS (set out 
in the WFD, and closely linked with REACH, as indicated in  Recital 28 of the EQSD).  These 
are described in the Commission Sta ff Working Paper SEC(2011)1544 (European 
Commission 2011).  
To support the imact assessment, a study was conducted by the consultancy Entec.  A 
‘bottom-up’ approach was developed that allo wed the assessment of impacts substance by 
substance, allowing aggregation of impacts in the different options.  The methodology is 
described in detail in the report by Entec (E ntec, 2011b). The individual substance reports 
from Entec are also available (Entec, 2011) . Th e fact sheets in Annex V of this report 
summarise the main results of the assessment of impacts for each of the substances.  
The main elements of the methodology were the following: – The approach to undertaking the impact assessment was based around a case study 
approach for individual substances in order to  assess the impacts of the possible outcomes 
of the review, using the best available info rmation.  In this appr oach, a number of case 
studies (generally two or  three per substance) we re carried out at a MS level.  The intention 
was to allow the impacts within the MS to be assessed in more detail than would be 
possible at the EU-level, due to the lesser amount of data  collection and consultation 
required.  This approach is also more feasible  where data availability is limited.  Multiple 
case studies were deemed necessary for each subs tance to ensure that the range of potential 
impacts (e.g. in different MS and impacts on different sectors) was covered.  Assumptions 
were applied because of data gaps. An assessment (predominantly qualitative) was then made of the applicabil ity of the case study findi ngs at the EU level. 
– The primary selection criterion for the initial case study (or studies) was monitoring data.  
In particular, MS where the monitoring data showed failure of the current or likely EQS 
were selected, to ensure that at least one case study was undert aken on a MS where 
impacts were likely to be identified.   
 
EN 79   EN – The impact of applying control measures for one substance on other substances was 
considered (since the application of measures for control of one substance may also imply 
control of other substances to  a greater or lesser extent). 
– A largely qualitative approach was taken to the assessment of impacts.  The scope for 
quantifying the benefits, especially the enviro nmental and social benefits (cf economic) 
was particularly limited.  Alt hough it was possible to put a fi gure on some costs (e.g. for 
advanced UWWT) and benefits (e.g. for recrea tional angling) it was not always possible to 
extrapolate. Section 5.2.1.1 presents  the main benefits that were  considered in  dealing with 
substances. More information can be f ound in section 2.6.7 of  the methodology report 
(Entec, 2011b). 
Assessment of additional monitoring costs for the substances  
Calculations were done using bottom-up (star ting from unit costs for analysis) and top-down 
(starting from overall figures on expenditure by MS) approaches to estimate the costs of 
adding substances to the PS list.   
A questionnaire was circulated to MS in 2010 to gather information on the costs of 
monitoring the existing PS. 22 MS replied and 16  gave information on monitoring costs, i.e. 
unit costs for sampling and analysis in the diffe rent matrices and overa ll current costs of 
monitoring of WFD PS. 
Two complementary methodological  approaches were applied to  these data to calculate 
monitoring costs. They are explained below. 
Bottom-up approach  
Some data treatment was carried out on the unit costs, i.e. removal of outliers and calculation 
of average unit values for sampling and analysis in water (total and di ssolved), sediment and 
biota. The results were as follows (EU average): 
Unit costs Euros  
Sample water 128 Average of total and dissolved (112 and 145) 
Sample sediment 228  
Sample biota 422  
Analysis water 133 Average of total and dissolved (105 and 162) 
Analysis sediment 128  
Analysis biota 151  
The proportions of sampling in water, sediment and biota were extracted as a starting point 
from the monitoring database compiled for the review. They were: 93% in water, 6% in 
sediment, 1% in biota. 
A weighted average of the sampling and analyti cal costs using these percentages resulted in 
the following unit costs: 
Sample weighted average 137 Euros
Analysis weighted average 133 Euros
 
EN 80   EN The Commission implementation report on the WFD Monitoring programmes of 200947 
identified 18535 sampling stations in 23 MS  where PS are being monitored, including 
operational and surveillance monitoring.  Extr apolation on the basis of population gives 
around 21500 stations in the EU27 in which PS are monitored. 
The minimum frequency of monitoring depends on the type of monitoring: monthly during 
one year out of six in the case of survei llance monitoring and monthly for operational 
monitoring. But there are flexibilities to re duce the frequency on th e basis of technical 
knowledge and expert judgement. For monito ring in biota or sediment, the minimum 
frequency is once per year (Article 3(2)c of EQ SD); a reduced frequency is also possible on 
the basis of technical knowledge  and expert judgement. Trend an alysis in sediment and biota 
for a number of PS as per Article 3(3) of the EQSD is once every 3 years. Overall, a value of 
2 samples per year will be used. 
It was necessary to take into account that only substances discharged into water bodies are 
monitored in them.  Moreover, each sampling point  is adequate to monitor the presence of a 
certain group of substances: pesticides, industr ial chemicals, metals, substances linked to 
consumer products/conurbations/UWWTPs, etc.. It  was assumed for the cost calculation that 
an average of between 20% and 40% of the substances  (8 to 16) are monitored per sample 
per station.  
On the basis of the above assumptions, the to tal estimated cost of current monitoring of 
existing PS in the EU27 was calculated to lie within the range 51 to 97 million €. 
The unit costs are assumed to be  robust since they are based on data from a good balance of 
MS (geographically and socio-economically). S till, the basis of some assumptions could 
change. For example, the proportion of sediment  and biota sampling is likely to increase as 
the EQSD is more fully implemented (Article 3(2)) and additional MS develop expertise in 
this. Water samples would still form the highest  proportion as the frequency of monitoring is 
much higher. Changing from the current figur es of 93, 6 and 1% respectively to 80, 15 and 
5% would result in an increase of 1 million € per year48, so a small percentage of the overall 
cost range calculated above.  
Top-down approach  
In response to the questionnaire referred to  above, 11 MS provided the overall costs of 
monitoring existing PS. Extrapolation to the whole of the EU27 on the basis of population 
leads to an estimate of the total costs of monitoring for existing PS of 57 million €.  
A sensitivity analysis was done to consider the influence of particular MS data on the 
estimate, since of the 11 MS, 4 were from  the EU15 and 7 from the EU12, and costs and 
expenditure tend to be higher in the former. Extrapolating separately resulted in 41 million 
(if only EU12 data were used) and 94 million (if only EU15 data were used). This confirms 
that the estimate of 57 million is towards the lower end of the range.  
 
                                                 
47 Main report: http://ec.europa.eu/environment/water/water-framework/implrep2007/pdf/sec_2009_415_en.pdf , 
Annex: http://ec.europa.eu/environmen t/water/water-framework/implrep2007/pdf/sec_2009_415_2_en.pdf  
48  Assumes the average frequency of monitoring of 2 samples per year. 
 
EN 81   EN Conclusions   
Feedback from MS confirms the robustne ss of the assumptions and results.   
There are a number of sources of uncertainty: 
– Flexibility provided by the WFD for MS to tailor monitoring programmes to the local 
situation and to select the matrix for mon itoring. A good overview was obtained from the 
reporting in 2007 (Article 8 of WFD)  and the Monitoring report of 200947, although 
programmes may have been adapte d later on at the RBMP stage.  
– Data on unit costs were obtained from only 16 MS.  However, they covered a good 
geographical and socioeconomic ra nge, and the plausibility of the results was confirmed by 
several MS and the JRC. 
– Data on the overall costs of monitoring of  existing PS were obtained from only 11 
MS, of which only 4 were from the EU15.  
– Monitoring of new substances may need some  development costs that are not reflected 
in the unit costs, which relate to routine monitoring of existing PS.  
– New substances (either newly proposed PS or substances a dded to the watch list) are 
not the same as the existing PS. However, the ty pes of substances are similar, the analytical 
techniques are frequently the same, and there is no reason to believe that costs will differ 
substantially.  
– For a few substances the analytical costs may be higher if very low determination 
limits are required. 
Resulting estimates for costs of monitoring for the EU (for the overall costs the lowest and 
the highest of the two calculations based on the two independent approaches is given): 
Million € Average Low High 
Unit costs sampling (weighted av erage for all matrices) 128 - - 
Unit costs analysis (weighted average for all matrices) 133 - - 
Overall costs of monitoring of existing PS 69 41 97 
Unit costs per PS based on overall monitoring 1.7 1 2.4 
 
Cost estimate for the watch list (relevant to options C2 and C3) 
Estimated annual monitoring costs for the watch list are in the following  table using the unit 
costs derived above for sampling and analysis a nd the range in number of  stations, substances 
and the average frequency of 2 samples per year, as presen ted in section 4.4.2: 
Million € 15 substances 25 substances 
 
EN 82   EN 250 stations 2.0 3.3 
300 stations 2.4 4.0 
These costs are calculated co nsidering one sample per analysis. This substantially 
overestimates the costs, as some of the substanc es will be of the same  type and therefore will 
be analysed in the same sample. If indeed only one sample were needed for all the substances, 
the costs would be halved.  
However, there is also an important source of underestimation. The analy tical costs that were 
reported by MS refer to routin e analysis of existing PS. There is a need to consider 
development and adaptation costs for the substances in the watch list, as they may not be 
analysed on a routine basis in the MS. This  could result in highe r costs per analysis. 
Increasing the unit costs of anal ysis by 50% would result in an  increased annual cost for the 
watch list of 25%, resulting in a tota l of 2.5 to 5 million € for the whole EU. 
It is estimated that the above sources of ove restimation and underestimation would partially 
cancel each other out. The range of the cost estima te (2 to 4 million €) is considered robust, as 
confirmed by consultation with MS, and represen ts between 3 and 6% of the current average 
overall costs of monitoring of PS (69 m illion, average of the range 41-97 million €). 
 
 
 
 
EN 83   EN ANNEX V: Substance factsheets  
Contents 
17-alpha-ethinylestradiol...................................................................................................... ... 84 
17-beta-estradiol.............................................................................................................. ........ 85 
Aclonifen...................................................................................................................... ........... 86 
Anthracene ..................................................................................................................... ......... 87 
Bifenox........................................................................................................................ ............ 88 
Cybutryne...................................................................................................................... .......... 89 
Cypermethrin................................................................................................................... ........ 90 
DEHP ........................................................................................................................... ........... 91 
Dichlorvos ..................................................................................................................... .......... 93 
Diclofenac ..................................................................................................................... .......... 94 
Dicofol........................................................................................................................ ............. 95 
Dioxins and DL-PCBs............................................................................................................ . 96 
Fluoranthene................................................................................................................... ......... 97 
HBCDD.......................................................................................................................... ......... 98 
Heptachlor ..................................................................................................................... .......... 99 
Lead........................................................................................................................... ............ 100 
Naphthalene.................................................................................................................... ....... 102 
Nickel ......................................................................................................................... ........... 103 
PAH............................................................................................................................ ........... 104 
PBDEs .......................................................................................................................... ......... 105 
PFOS ........................................................................................................................... .......... 106 
Quinoxyfen..................................................................................................................... ....... 107 
Terbutryn...................................................................................................................... ......... 108 
Trifluralin .................................................................................................................... .......... 109 
These substance factsheets are essentially ba sed on the information in Entec (2011) and 
technical documents (EQS dossiers, source-sc reening and measures sheets) produced during 
the review process. 
 
EN 84   EN  
17-alpha-ethinylestradiol (EE2) factsheet  
Proposal:  New priority substance Proposed status:  PS 
Proposed critical EQS:  AA-EQS freshwater,eco  Fresh 3.5 10-5  Salt 7 10-6 
Rationale:  
Endocrine disruptive; risk ratio >1 
Main sources (produc tion, use etc):   
Synthetic steroid most commonly used as the oestrogen comp onent of combined oral cont raceptives; also in the 
treatment of menopausal and post-menopausal symptoms  and for other medicinal purposes. No data on 
production in the EU, though indications of production in DE. Approx 32 million women use EE2-based oral 
contraceptives in the EU. Consumption varies widely, from  52% of women between 15 and 49 years old in DE to 
3.4% in PL. EE2 is excreted by people that consume it (57-85% is excreted unchanged) and enters the 
environment primarily through the sewerage wastewater system.  
BASELINE  
Monitoring and predictions show exceedances of the EQ S in water (see "Uncertainties"). Emissions may be 
reduced due to improvement in waste wa ter treatment driven by the general good status objective of the WFD. 
Public awareness of take-back schemes for unused or expired pharmaceuticals very variable (73% Swedish 
know, 77% British do not). Data on su ccess of take-back schemes generally lacking but also very variable. 
IMPACTS 
Costs:  
Some potential measures identified but effectiveness very difficult to estima te as no experience of reducing 
environmental impact of pharmaceuticals in use. Current EU  legislation does not provide the mechanisms to take 
most of these measures at EU le vel. Most feasible measures (e.g . improvement of take-back schemes, 
information to patients, doctors and pharmacists to infl uence prescription and achieve partial replacement by 
alternative contraceptives, etc) would be expected to reduce consumption of EE2 ov er the long term and increase 
that of alternatives, e.g. the progestogen-only pill, whose active hormone undergoes higher removal rates in 
UWWTPs. Long-term economic impacts on pharmaceutical companies produci ng EE2-based contraceptive pills 
due to reduced sales (current sales in EU are estimated at several hundred million €) unless they can move into 
the market for alternatives. 
Admin costs: Monitoring costs for MS. Depending on the de sign of the take-back schemes and awareness raising 
programmes, there might be additional costs incurred by public bodies. 
Benefits:  
Better knowledge of water quality and therefore better possibilities for targeting measures.  Environmental 
benefits of decreasing environm ental concentrations below no-effect levels , in particular for fi sh, possible increase 
in sustainability of fish stocks through reduced negat ive impacts on fish reproduction. Benefits for wider 
biodiversity related to increased fish stocks. Potent ial economic and social benefits related to commercial 
fisheries and recreational uses (angling). Economic benefits  for pharmaceutical companies selling alternatives to 
EE2. Lower risk of endocrine–disrupting substances in drin king water, hence potential savings in drinking water 
treatment. 
Special points:   
Sectors (most relevant): Fisherie s, medical, pharmaceuticals. 
Geographical impacts: Widely used across the EU, but higher usage in DE, PT, BE, FR, NL and HU.  
Uncertainties:  
Extent of monitoring of this "emerging pollutant" limited (3 countries in dat abase, plus literature). Usefulness of 
monitoring information also limited because limits of detect ion usually 2 orders of magni tude higher than the EQS. 
No information on production in the EU. Uncertainties regarding effectiveness of measures due to the lack of 
experience in reducing the environmenta l impact of pharmaceuticals in use.  
 
 
EN 85   EN  
17-beta-estradiol (E2) factsheet  
Proposal:  New priority substance Proposed status:  PS 
Proposed critical EQS:  AA-EQS freshwater,eco  Fresh 4 10-4  Salt 8 10-5 
Rationale:  
Endocrine disruptive; risk ratio >1 
Main sources (produc tion, use etc):   
Naturally-occurring steroidal oestrogen produced by humans, livestock and wild animals.  Also used to 
manufacture synthetic oestrogenic and hormonal products. Natural excretion of E2 by humans and animals 
accounts for around 90% of emissions to surface waters. Excretion from livestock is 10 times higher than from 
humans (estimated in the EU at 1000 kg /day for livestock vs 100 kg/day for humans) but human discharge is fully 
to water, cf. only a fraction of the livestock excretion. Therefore human and livestock emissions to water estimated 
to be of the same order of magnitude.  Pharmaceutical uses of E2 account for less than 10% of total emissions, of 
which 90% due to hormone replacement therapies (HRT ) (800 to 2200 kg/year) the rest to use in oral 
contraceptives. 
BASELINE  
Monitoring and predictions show exceedances of EQS in water (see "Uncertainties"). Emissions to surface water 
from human excretions may be reduced due to improvement  in waste water treatment driven by general good 
status objective of the WFD. Emissi ons from livestock likely to be reduced due to increased protection of water 
courses at farm level driven by WFD, Nitrates Directive  and the Directive on the Sust ainable Use of Pesticides, 
through the implementation of buffer strips.  
IMPACTS 
Costs:  
Some potential measures have been identif ied but effectiveness very difficult to estimate. Measures should focus 
on reducing emission due to human and livestock excret ion (e.g. improvements to UWWTPs and protection of 
water courses from livestock). Emissions from pharmac eutical uses would be reduced at the same time by 
improved UWWTPs.  
Difficult to estimate the need for additional measures to reduce emissions to water from livestock beyond the 
baseline. Cost of fencing to avoid livestock access to  water courses is estimated at 2 to 12 €/ha/year.  
Estimated costs to upgrade UWWTPs to remove E2: For England and Wales: 18 € per inhabitant per year based 
on a stricter EQS than that  proposed; For CH: 11-18 € per inhabitant per year depending upon the number of 
plants to be upgraded. These costs assume no source co ntrol and, if entailed, would likely be passed through in 
full or in part to consumers, within proportionat e limits (exemptions could be applied on grounds of 
disproportionality or non-feasibility). Significant increase in  energy use due to increased treatment (equivalent to 1 
million tons of CO 2 in England and Wales). 
Admin costs: Monitoring costs for MS.  
Benefits:  
Better knowledge of water quality and therefore better possibilities for targeting measures.  Environmental 
benefits of decreasing environm ental concentrations below no-effect levels , in particular for fi sh, possible increase 
in sustainability of fish stocks through reduced negat ive impacts on fish reproduction. Benefits for wider 
biodiversity related to increased fish stocks. Potent ial economic and social benefits related to commercial 
fisheries and recreational uses (angling). Increased wast e water treatment will reduce discharge of many other 
pollutants. Lower risk of endocrine-disr upting substances in drinking water,  hence potential savings in drinking 
water treatment. 
Special points:   
Sectors (most relevant): Fisheries, livesto ck farming, pharmaceuticals, sewerage/water. 
Geographical impacts: Highest emissions estimated for FR, DE, UK, IT, ES, PL, IE and NL.  
Uncertainties:  
Uncertainties regarding the proportion of E2 from livesto ck that reaches surface wate rs. Uncertainties about the 
effectiveness of the WFD measures included in the baseli ne to limit human and livestock E2 emissions to water. 
Limited monitoring information available for this "emerging pollutant" (2 countries in database, plus literature) and 
its usefulness is reduced because llimits of determination often higher than the EQS).  
 
EN 86   EN  
Aclonifen factsheet  
Proposal:  New priority substance Proposed status:  PS 
Proposed critical EQS:  AA-EQS freshwater,eco  
Proposed corresponding EQS in freshwater:   0.12 µg/l 
Not relevant 
Rationale:  
Ranked high in modelling based prioritisation; bioaccumulative and toxic (and some evidence of persistence); risk 
ratio >1 
Main sources (produc tion, use etc):   
Herbicide manufacture and use (over 1000 tonnes/yr).  Use as pre-emergence herbicide on a range of arable 
crops, especially potatoes, peas, maize, sunflowers.  Also in forestry (tree nurseries).  Losses to water by way of 
spray-drift, run-off, spills.  
BASELINE  
Monitoring data from 3 MS; exceedances of EQS in FR (which has the highest use and the most substantial 
monitoring dataset). Losses to water likely to decrease as  a result of recently in troduced requirement under 
Directive 91/414/EEC for buffer strips next to water course s. Likely to be aided by implementation of the Directive 
on Sustainable Use of Pesticides. 
IMPACTS 
Costs:  
Buffer strips already obligatory, but wi der strips and/or additional measures  might be locally required in response 
to monitoring results. 
Admin costs: Monitoring costs for MS. 
Benefits:  
Better knowledge of water quality; feedback to the PPP aut horisation process.  Possible additional benefits to 
biodiversity if measures improved. Re duced risk of failure of individual and total pesticides standards in drinking 
water. 
Special points:   
Note: Many benefits expected to be ac hieved under the baseline, but could be accelerated if improved knowledge 
of concentrations leads to better management, e.g. wi der buffer strips, better timing of application, more 
widespread restrictions on spray-equipment cleaning methods. 
Sectors (most relevant): Agriculture (arable). 
Geographical impacts: Widely used in EU (18 MS in 2008) but 70% in FR.  7 formulators in FR, 1 in SE (the case-
study MS); no data for other MS.  Active subs tance produced in FR by DE-based company. 
Uncertainties:  
Extent of failure of EQS following recent introduction of  buffer zones under Directive 91/414/EEC and adoption of 
the Directive on the Sustainable Use of Pesticides.  Uncertainty regarding peak concentrations following 
application. 
 
 
EN 87   EN  
Anthracene factsheet  
Proposal:  More stringent MAC for existing substance. Proposed status: Unchanged (PHS due to PBT 
properties) 
Proposed critical EQS:  QS freshwater, eco   
Proposed corresponding EQS in freshwater:   
Proposed MAC:  Unchanged 
Not relevant 
0.1 μg/l (cf 0.4 μg/l) 
Rationale: 
Review of the QSs prompted by revised RAR for pitch.  C onclusion that high acute toxicity justifies setting MAC 
equal to AA-EQS.  
Main sources (produc tion, use etc):   
Aromatic hydrocarbon.  Occurs natura lly in fossil fuels/derivatives and is produced during combustion; is therefore 
emitted from many industrial processes using fossil fuel s or involving combustion. Pure anthracene (approx 1000 
tonnes per annum in EU) manufactured from coal tar pi tch for limited range of uses (e.g. pyrotechnics 0.2 
tonnes).  Produced in larger quantities (estimated 27000 tonnes per annum) in coal-tar distillation products. Coal 
tar pitch can be considered main use; in binding a gents for e.g. electrodes, r oad construction, roofing. 
Total emissions highest from coke production, aluminiu m production, creosote and wood preservation (restricted 
conditions since 2003), domestic fuel combustion, v ehicle engines, tyres (production and use), agricultural 
burning and forest fires, though half-life in air short, therefore atmospheric depos ition relatively low cf some other 
PAHs, though still significant. Emissions to water (app rox 9 tonnes in E-PRTR 2008) highest from metals 
production.  
BASELINE  
4 MS report current failure of existing AA-EQS. Monito ring database reports some concentrations higher than 
proposed MAC. Regulation (EC) No 850/2004 on POPs  imposes release reduction provisions; REACH Annex 
XVII restrictions. possible inclusion in Annex XIV; IPPC Dir ective/IED; Directive 2004/107 on concentrations in air; 
Directive  98/70/EC on PAH content of diesel; Various BATs and BREFs, e.g. for aluminium production; 
Regulation (EC) No 1881/2006 on food standards for PAHs; inclusion in Annex I of Directive 98/8/EC effective 
from May 2013.. 
IMPACTS 
Costs:  
Mostly in baseline, since existing AA-EQS already 0.1 μg/l and existing MAC only four-fold less stringent, and 
emissions to water should be phased out anyway. 
Possibly additional measures directed at (industrial) point  source emissions (more relevant to MAC than diffuse 
sources).  
Admin costs: None beyond baseline, except possibly additional permitting administration and additional targeted 
monitoring in the short term. 
Benefits:  
Mostly in baseline, but possible acceleration of lo cal improvements in water quality and ecosystem health. 
Special points:   
Note: Although accumulation in biota is relevant (secon dary poisoning), critical EQS remains direct toxicity. 
Sectors (most relevant): Coal tar di stillation; energy, metals production. 
Geographical impacts:  Relevant industries (point sources) more prevalent in some MS than others. 
Uncertainties:  
Extent of failure of current MAC in all MS; inclusion or not in REACH Annex XIV. 
 
EN 88   EN  
Bifenox factsheet  
Proposal:  New priority substance Proposed status:  PS 
Proposed critical EQS:  AA-EQS freshwater,eco  
Proposed corresponding EQS in freshwater:   1.25 10-2 µg/l 
Not relevant 
Rationale:  
Ranked high in modelling based prioritisation, very toxic, risk ratio >1 
Main sources (produc tion, use etc):   
Herbicide manufacture and use (over 200 tonnes/yr).  Use as post-emergence herbicide  predominantly on winter 
cereal crops, also on some grasslands. Losses to  water by way of spray-drift, run-off, spills.  
BASELINE  
Monitoring data from 3 MS; exceedances of EQS in FR (which has the highest use and the most substantial 
monitoring dataset). Losses to water likely to decrease as a result of Directive on Sustainable Use of Pesticides. 
IMPACTS 
Costs:  
If buffer strips already obligatory (as in some MS), no a dditional cost to farmers; additional measures might be 
locally required in response  to monitoring results. 
Admin costs: Monitoring costs for MS. 
Benefits:  
Better knowledge of water quality; feedback to the PPP aut horisation process.  Possible additional benefits to 
biodiversity. Reduced risk of failure of individual a nd total pesticides standards in drinking water. 
Special points:   
Note: Many benefits expected to be ac hieved under the baseline, but could be accelerated if improved knowledge 
of concentrations leads to better management, e.g. (w ider) buffer strips, better timing of application, more 
widespread restrictions on spray-equipment cleaning methods. 
Sectors (most relevant): Agriculture (arable). 
Geographical impacts: Widely authorised in EU (19 MS) but most use in FR. Marketed by 3 companies in FR and 
3-4 in UK (the case-study MS); no data for other MS, but production of active substance likely to be in Israel 
(head office of producer based there). 
Uncertainties:  
Extent of failure of EQS following re cent adoption of the Directive on t he Sustainable Use of Pesticides.  
Uncertainty regarding peak concentrations following application. 
 
 
EN 89   EN  
Cybutryne factsheet  
Proposal:  New priority substance Proposed status:  PS 
Proposed critical EQS:  AA-EQS freshwater,eco  
Proposed corresponding EQS in freshwater:   0.0025 µg/l 
Not relevant 
Rationale:  
Substance of concern in MS, toxic, risk ratio >1; degrades  only slowly; main degradation product (M1) also toxic; 
persists in sediments. 
Main sources (produc tion, use etc):   
Biocidal (algicidal) use - approx 10 tonnes/yr in EU (inc omplete data) - especially as antifouling agent in coatings 
for boat hulls (commercial, recreational) and on marine equi pment/constructions, but also in coatings on buildings.  
Losses to water mainly by leaching from coated surfaces; some losses during application.  Leaching losses in NL 
continental shelf sea estimated at 850 kg in 2007.  
BASELINE  
Monitoring database contains data from 3 MS and CH showing exceedance or near-exceedance of proposed 
EQS in 2 MS and CH); data in literatur e confirm potential for exceedance. Some national bans on use for small 
vessels have recently come into force. Uses as antif ouling agent and film/masonry preservative currently being 
reviewed under the Biocidal Products Directi ve 98/8/EC; outcome could affect baseline. 
IMPACTS 
Costs:  
Any additional material costs for substitutes.  Labour costs if use more frequent mechanical 
cleaning/maintenance. Increased shipping fuel costs/CO 2 etc emissions if alternatives less effective.  Costs might 
be passed on to consumers/passengers.  
Admin costs: Monitoring costs for MS. Possibly sediment remediation costs. 
Benefits:  
Better knowledge of water quality; feedback to the biocidal  products authorisation process; information to support 
remediation.  Possible benefits to biodiversity, and to fisheries and angling. Stimul ation of innovation to find 
additional alternatives.  Employment opportunities if more frequent mechanical cleaning/maintenance. 
Special points:   
Note: Some benefits likely to be achieved under the baseli ne, but not all MS have national bans in place and only 
small vessels are covered. 
Sectors (most relevant): Coatings, Construction, Fisher ies, Leisure (angling, boating), Transport (shipping)  
Geographical impacts:  Produced by BASF (DE-based), possibly in CH.  MS with coastlines likely to benefit most, 
especially if (partial) ban not already in place (as in DK, SE, UK). Benefits to third countries if EU boats use less 
harmful antifouling agent. 
Uncertainties:  
Extent of failure of EQS following introduction in some  MS of national bans.  Extent of use on buildings. 
 
 
EN 90   EN  
Cypermethrin factsheet  
Proposal:  New priority substance Proposed status:  PS 
Proposed critical EQS:  AA-EQS freshwater,eco  
Proposed corresponding EQS in freshwater:   8.2 10-5 µg/l 
Not relevant 
Rationale:  
Ranked very high in monitoring-based prioritisation and high in modelling-based prioritisation; very toxic; risk ratio 
>1 
Main sources (produc tion, use etc):   
Insecticidal PPP and biocide: approx up to 100 tonnes/yr used in EU.  Used as PPP on arable crops, in orchards 
and forestry, and as biocide in wood preservatives and for veterinary use (sheep dipping, salmon farming).  
Secondary release from textile factories using wool. 
BASELINE  
Monitoring database contains data from 5 MS showing exceedance of proposed EQS in 3 MS, in particular UK. 
National ban on use in sheep dipping now in force in UK. Biocidal uses currently being reviewed under the 
Biocidal Products Directive 98/8/EC; outcome could affect  baseline.  Use in salmon farming apparently declining 
but could be temporary due to practice of rotating ch emical treatments to cope with resistance development. 
IMPACTS 
Costs:  
Costs to arable farmers of implementing buffer zones. Co sts to sheep farmers of measures to reduce entry of 
cypermethrin into water (possibly of the order of 10 million Euros per MS based on estimates by the UK). Costs to 
textile factories of effluent treatment. Costs to sa lmon farmers of using management measures to ensure 
compliance with EQS. In Scotland, a quality standard wa s introduced several years ago but salmon farmers have 
been able to continue using Cypermethrin with appropriate  management   If cypermethrin use could not continue 
(despite no proposal to designate it as a PHS), possible cost of finding substitutes to maintain portfolio of 
treatments for rotation, although alte rnative treatment using hydrogen pero xide (less harmful to environment) 
already being developed. Additional material costs for substi tutes, if relevant. In horticulture and cereal cropping, 
alternatives generally available, plus possibility of co ntrolling certain pests by irrigation management. Loss of 
cypermethrin (though not foreseen in the options) would ha ve only a minor impact, except in the context of vine 
weevil control, where in the UK at least t here could be some costs (ADAS 2010, HGCA 2009). 
Admin costs: Monitoring costs for MS.   
Benefits:  
Better knowledge of water quality; feedback to the PPP an d biocidal products authorisat ion processes.  Possible 
benefits to biodiversity and to fisheries and angling.  
Special points:   
Note: Some benefits likely to be achieved under the baseline where ban on use in sheep dipping already 
introduced. 
Sectors (most relevant): Aquacultur e, Agriculture, Pesticides (Bioci des, Plant Protection Products). 
Geographical impacts:  Formulations manufactured by 5 co mpanies in EU, location not known; active substance 
produced at least partly outside EU.  Authorised in most  MS.  Impacts less severe where ban on use in sheep 
dipping already in place.  Salmon farming only an issue for DK, IE, UK. 
Uncertainties:  
Extent of failure of proposed EQS in several MS in absen ce of sufficiently sensitive analytical method. Extent of 
failure in UK following ban on use in sheep dipping in UK. Extent to which used for sheep dipping in other MS 
(ES, FR, IT, RO have high numbers of sheep). Likely trend in use in agriculture and forestry. Outcome of Biocidal 
Products Directive review.   
 
 
EN 91   EN  
DEHP factsheet  
Proposal:  New status for existing substance Proposed status:  PHS 
Proposed critical EQS:  Unchanged   
Proposed corresponding EQS in freshwater:   As in existing EQS Directive 
 
Rationale: 
Reprotoxic Cat 1B (Reg (EC) No 1272/2008), SVHC under  REACH and listed in Annex XIV of REACH, EU RAR 
(2008) 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 childre n in relation to exposure via the environment (taking 
account of existing risk reduction measures). 
Main sources (produc tion, use etc):   
Industrial chemical, used as plasticiser in polymers, mainly in flexible PVC (for roofi ng, piping, tubing, flooring, 
furniture, clothing etc) and, to a lim ited extent in some non-polymer products.  Emissions to environment during 
production, formulation, use and dispos al – highest from disposal (consisting mainly of emissions from non-
managed disposal, i.e. waste remaining in the environment  from use), but also significant through run-off, 
washing/abrasion etc during use, especi ally from outdoor polymer use to so il and from indoor use to water. E-
PRTR reports 21 tonnes emitted through UWWTPs in 2008 (approx 97% of total to water), 10 tonnes from 
chemical industry to air, but these emissions may not cover many of the emissions from use.  
BASELINE  
Failures of EQS currently in at least four MS (data not  complete).  REACH Annex XIV authorisation required from 
Feb 2015; temporary authorisation for some uses likely – possible derogations for some uses.  Eventual 
substitution, therefore decrease in emissions from new us e, expected in due course.  (Substitutes exist for DEHP 
and final product type. DEHP was 18% of plasticiser use in 2009.) But emissions from existing use likely to 
continue for some time. Legislation on industrial emissi ons contains measures relevant to DEHP and PVC.  
Directives on incineration and landfill of  waste contain generic requirements.  
IMPACTS 
Costs:  
Mostly in baseline. 
Impacts on DEHP producers and companies processing flex ible PVC (approx 800 in EU), including impacts on 
employment (though could shift to alternative substances/p roducts), and additional cost of substitutes, estimated 
at 9 to 21% in 2008 (could be passed to consumers, but  could decrease with increased use). Additional water 
treatment (waste water, storm wate r run-off, landfill leachate) including cost of SUDs and energy costs, CO 2 
emissions. To cease all emissions, replacement of many PVC fixtures/fittings/products; costs of correct disposal. 
However, such water treatment or product replacem ent before natural "end-of-life" would be subject to 
assessment of costs, including environm ental costs, and exemptions on the basis of disproportionate costs and 
non-feasibility could be applied. 
Admin costs: Possibly remediation costs (MS and/or indust ry). Possibly costs of scheme(s) to remove products 
from use (though such schemes unlikely). 
Benefits:  
Mostly in baseline. 
Better water quality and reduced build-up of DEHP in sediments; potential for better human health. Knock-on 
benefits of measures such as SUDs. 
Special points:   
Note: PHS designation consistent with approach under REACH. Many benefits expected to be achieved under 
the baseline, but could be accelerated/enhanced. 
Sectors (most relevant): Construction, electrical, footwear, medical, plasti cs/polymers, textiles, water/sewerage. 
Geographical impacts: Production in fewer than 10 MS (possi bly only 7 sites remaining); considerable variation in 
reported releases (E-PRTR) to water and air. 
Uncertainties:  
Extent of failure of EQS in some MS. Exact number  of DEHP producers. Data on human health and 
environmental impacts of some alternatives. Outcome of REACH authorisation process. In addition to REACH, 
 
EN 92   EN separate consideration being given to banning use in electrical equipment and PVC – outcome not certain. 
Impacts on import. 
 
 
EN 93   EN  
Dichlorvos factsheet  
Proposal:  New priority substance Proposed status:  PS 
Proposed critical EQS:  AA-QS freshwater, eco  
Proposed corresponding EQS in freshwater:   6 10-4 µg/l 
Not relevant 
Rationale:  
Ranked very high in monitoring-based prioritisation, medium in modelling-based prioritisation, risk ratio >1; 
possibly carcinogenic to humans (IARC 2B, Carc. Cat. 3 probable under Dangerous Substances Directive); 
potential for local mutagenicity. 
Main sources (produc tion, use etc):   
Use as organophosphorus insecticide.  Residual non-authorised use as PPP.  Possible losses from biocidal use, 
e.g. from indoor use on grain/ nut stores, use of insecticidal sprays etc (largely indoor but also outdoor, including 
domestic use).  Leaching from disposal of unused products. 
BASELINE  
Monitoring shows evidence of failure of EQS in 7 MS, possibly others. Losses to water should decrease since no 
longer in Annex I of Directive 91/414/EEC (effective as of 2008). 
IMPACTS 
Costs:  
Possibly additional water treatment costs. Possible costs to current producers if cons umption decreases, e.g. if 
certain product types no longer authorised (t hough impacts most likely in baseline). 
Admin costs: Monitoring costs for MS. 
Benefits:  
Better knowledge of water quality; potential for better water quality and ecosystem hea lth; therefore potential for 
better aquaculture/fisheries/angling.   
Special points:   
Note:  Most use apparently indoors, but some outdoor use (e.g. on mosquitoes) still authorised, and disposal 
could pose a risk. Exposure in humans largely by inhalation. 
Sectors (most relevant): Biocidal  product manufacturers, Consumers. 
Geographical impacts: Possible impacts on India (produ cer) depending upon outcome of Biocidal Products 
review, and on one or more EU product formulators.  Authorisation already withdrawn in DK, SE, UK. Reported 
use seems highest in IT. 
Uncertainties:  
Extent of failure of proposed EQS in several MS in absenc e of sufficiently sensitive analytical method. Outcome of 
Biocidal Products Directive review. 
 
 
EN 94   EN  
Diclofenac factsheet  
Proposal:  New priority substance Proposed status:  PS 
Proposed critical EQS:  AA-EQS freshwater,eco  
Proposed: MAC-EQS freshwater,eco   0.1 µg/l (freshwater), 0.01 µg/l (saltwater) 
75 µg/l (freshwater), 7.5 µg/l (saltwater) 
Rationale:  
Toxic; risk ratio >1 
Main sources (produc tion, use etc):   
Non-steroidal anti-inflammatory drug (NSAID), suitable for human and veterinary use, first introduced in the UK in 
1979. Diclofenac has anti-inflammatory, antipyretic and analg esic action. Four producers in the EU according to 
ESIS. Average consumption of 0.46 g per person per year but varies widely (0.05 to 0.89 based on data from 9 
MS). Emissions via excretion and discard of unused medicines in sink/toilet or domestic waste. 
BASELINE  
Monitoring and predictions show exceedances of the EQS in  water (DE, FR, IT, UK, SE, AT, PL). Consumption of 
NSAIDs has shown an upward trend over recent years in Central and Eastern European countries (Inotai A et al 
,2010). Public awareness of take-back schemes for unused or expired pharmaceuticals very variable (73% 
Swedish know, 77% British do not). Data on success of take-back schemes generally lacking but also very 
variable. 
IMPACTS 
Costs:  
A wide range of measures could be implemented but effect iveness very difficult to estimate as no experience of 
reducing environmental impact of pharmaceuticals in use. Current EU legislation does not provide the 
mechanisms to take most of these measures at EU level.  Most feasible measures (e .g. improvement of take-back 
schemes, influence of prescription, information to patients,  doctors and pharmacists, etc) are expected to have a 
long-term effect to reduce consumption of diclofenac  and increase other alternative anti-inflammatory drugs. 
Long-term economic impacts on pharmaceutical companie s producing diclofenac due to reduced sales, unless 
they can move into the market for alternatives. 
Admin costs: Monitoring costs for MS. Depending on the de sign of the take-back schemes and awareness-raising 
programmes, there might be additional costs incurred by public bodies. 
Benefits:  
Better knowledge of water quality and therefore better possibilities for targeting measures.  Environmental 
benefits to decrease environmental concentrations below no -effect levels, in particular for fish. Economic benefits 
for pharmaceutical companies selling alternatives to diclofenac. 
Special points:   
Sectors (most relevant): Medical, pharmaceutical. 
Geographical impacts: Widely used across the EU, but hi gher usage per inhabitant in DE, EE, PL, SE and UK. 
Production in the EU located in DE and IT.  
Uncertainties:  
Limited information about levels in the aquatic environment in large parts of the EU.  
Important uncertainties as regards the effectiveness of the measures due to the lack of experience in reducing the 
environmental impact of pharmaceuticals in use.  
 
 
EN 95   EN  
Dicofol factsheet  
Proposal:  New priority substance Proposed status:  PHS 
Proposed critical EQS:  QS biota, sec pois  
Proposed corresponding EQS in freshwater:   33 µg/kg biota ww 
1.3 10-3 µg/l 
Rationale:  
Annex III substance; ranked hi gh in monitoring and in mode lling based prioriti sation, risk rati o >1; recommended 
for designation as POP (Stockholm Convention); possibly carcinogenic to humans, possibly endocrine disruptive; 
organochlorine PPP, similar to DDT.   
Main sources (produc tion, use etc):   
Possibly residual (non-authori sed) use as PPP, predomi nantly against mites and ticks on fruits, vegetables and 
ornamentals, thence losses to water by way of spray-drift, run-off, spills.  Otherwise secondary release, e.g. by 
leaching, from contaminated soils and sediments.  
BASELINE  
Monitoring shows evidence of failure of EQS in ES and FR, with uncertainty regarding other MS. Losses to water 
should decrease since no longer in Annex I of Directive 91/414/EEC (effective as of March 2010). 
IMPACTS 
Costs:  
Admin costs: Monitoring costs for MS.  Possibly sediment remediation costs. 
Benefits:  
Better knowledge of water quality; remediation if necessa ry, with potential for better water quality and better biota 
and human health; potential for better aquaculture/fisheries/angling. 
Special points:   
Note: Most benefits expected to be achieved under the baseline, but could be accelerated if monitoring results 
lead to remediation. 
Sectors (most relevant): None particularly beyond baseline (assuming no longer manufactured in EU). 
Geographical impacts: Impacts on ES, IT and non-EU produc ers already in baseline (assuming not manufactured 
in EU only for export). Dicofol was authorised in 11 MS , many of which withdrew aut horisation in the 1990s. ES, 
FR and IT known to have been users until 2010 - might have more need for remediation. 
Uncertainties:  
Extent of failure of proposed EQS in several MS in absen ce of sufficiently sensitive analytical method. Extent of 
failure of EQS following exclusion from Annex I of Directive 91/414/EEC. 
 
EN 96   EN  
Dioxins and Dioxin-like-PCBs factsheet  
Proposal:  New priority substance Proposed status:  PHS 
Proposed critical EQS:  QS biota, sec pois   
Proposed corresponding EQS in freshwater:   8 10-3 µg TEQ/kg biota wwNone calculated. 
Rationale:  
Annex III substances. POPs (Stockholm Convention and  CLRTAP). PBT properties. Ranked very high in 
monitoring-based prioritisation; some congeners probably carcinogenic to humans, possibly endocrine disruptive. 
Main sources (produc tion, use etc):   
Dioxins are unintentional by-products of  thermal processes involving organic  matter, e.g. during power station 
combustion, non-ferrous metals production and other indust rial manufacturing, waste incineration, forest fires. 
Atmospheric deposition widespread. Direct emissions to water from organic chemicals production, pig-iron and 
steel production, chlorine-based industries, e. g. paper production, text ile washing/bleaching. 
PCBs are chlorinated organic compounds formerly produc ed and used in EU in manufacturing electrical and 
hydraulic equipment and lubricants et c; 12 congeners are dioxin-like. Co mbustion of waste may produce some 
DL-PCBs. Atmospheric deposition occurs. Most direct em issions to water are from urban wastewater treatment 
plants, probably from ongoing use of PCB-based flooring, sealants and paints. 
Secondary emissions of dioxins and DL-PCBs possible,  e.g. leaching from land fills and contaminated soils, 
release from sediments.  
BASELINE  
Monitoring shows evidence of failure of tentative water and/or sediment EQS in several MS, and some 
exceedances of draft biota EQS. Emissions have decr eased because of action under international and EU POPs, 
waste and industrial emissions legislation, including ELVs on emissions of dioxin from waste incineration, BREFs 
on emissions from industrial processes, requirements for t he disposal of PBC-containi ng waste and restrictions on 
transboundary movements of hazardous waste. PCBs banned fo r use in open applications since 1976 (Directive 
76/403/EEC) and closed applications si nce 1985 (Directive 85/467/EEC), t hough remain in flooring, sealants, 
paints etc.  Food standards exist. 
IMPACTS 
Costs:  
Most costs in baseline. Possibly additional  water-treatment costs, including energy/CO 2 emissions. Possibly 
accelerated measures to reduce the likelihood of dioxin s formation in industrial/domestic combustion processes 
(e.g. optimal combustion conditions, fuel switching), to capture dioxins from emitted gases, and to reduce the 
likelihood of accidental fires.  Possibly 5-10% reduced efficiency of blast furnace operation with optimised 
emissions. Possible earlier investment in measures (e.g. insulation) to reduce fuel consumption. Possible costs to 
replace PCB-containing materials and items in buildings  (and dispose of PCB-containing items correctly).  
Possible passing on of costs from industry to consumers, especially energy costs. 
Admin costs: Monitoring costs for MS.  Possibly sediment remediation costs. 
Benefits:  
Most benefits in baseline. Better knowledge of wate r quality; avoidance of environmental accumulation (by 
accelerated measures); remediation if necessary; poten tial for better water quality and better biota and human 
health; potential for better aquaculture/fi sheries/angling; improved consumer co nfidence (though could be lower in 
the short term); reduced likelihood of exceeding food standard and WHO Tolerable Daily Intake. Possible 
stimulation of innovation; benefits to  producers of abatement/cleaner te chnologies. Possible employment in 
remediation work.   
Special points:   
Note: Most costs and benefits expected to be realis ed under the baseline, but could be accelerated. 
Sectors (most relevant): None particularly beyond baseline. 
Geographical impacts: Most impacts already in baseline; could be higher remediation costs in some MS due to 
concentration of certain industries. 
Uncertainties:  
Extent of failure of proposed EQS in several MS in absence of sufficiently sensitive analytical method. 
 
EN 97   EN  
Fluoranthene factsheet  
Proposal:  Biota EQS as critical EQS.  Corresponding 
water EQS much more stringent than existing EQS.  
MAC also more stringent. Proposed status: Unchanged (PS) 
Proposed critical EQS:  QS biota, hh   
Proposed corresponding EQS in freshwater:   
Proposed MAC:  30 μg/kg biota ww (freshwater and marine) 
6.3 10-3 μg/l (cf 0.1 μg/l) (freshwater and marine) 
0.12 μg/l (cf 1.0) (freshwater and marine) 
Rationale: 
Review of the QSs prompted by revised RAR for pitch.  
Main sources (produc tion, use etc):   
Aromatic hydrocarbon.  Occurs natura lly in fossil fuels/derivatives and is produced during combustion; is therefore 
emitted from industrial processes using fossil fuels or in volving combustion. Not produced or used in pure form. 
Used through use of coal tar pitch, high temperature (CTPHT); production approx 800000 tonnes in 2004 in EU, 
small amount imported, more than one third exported. Main use in binding agents for e.g. electrodes, furnace 
lining materials (refractories), road construction, roofing.   Also present in creosote, tar paints, tyres etc..  
Reported emissions to water approx 8.5 tonnes in E-PRTR  2008, highest from the ener gy sector (mainly from 
refining and combustion) and metals production (particu larly aluminium, though 2009 emissions from one major 
contributor are much lower). Other emissions to water fr om production of basic organic chemicals, and from wood 
treatment with creosote etc.  Emissions  from incomplete combustion (including from vehicles, domestic fuel and 
agricultural burning, and wildfires) may lead to atmospheric deposition.  
BASELINE  
8 Member States report current failure of existing AA-EQS in at least one water body. INERIS monitoring 
database reports some concentrations higher than prop osed EQS and MAC. Regulation (EC) No 850/2004 on 
POPs imposes release reduction provisions; REACH Annex  XVII restrictions. possible inclusion in Annex XIV; 
IPPC Directive; Directive 2004/107 on concentrations in air;  Directive 98/70/EC on PAH content of diesel. Various 
BATs and BREFs, e.g. for aluminium production; Regula tion (EC) No 1881/2006 on food standards for PAHs, 
inclusion in Annex I of Directive 98/8/EC effective from May 2013.  
IMPACTS 
Costs:  
Possibly additional measures directed at (industrial) point source emissions. Possible additional waste water 
treatment. 
Admin costs: Possible change in monitoring costs due to  shift to biota standard. Possibly remediation costs (MS 
and/or industry). 
Benefits:  
Better knowledge of water quality (due to switch to bi ota monitoring). Improvement in water quality; decreased 
scope for accumulation in the environment (fluoranthene bi nds to particles), potential for better biota health and 
better aquaculture/fisheries/ angling (includi ng reduced wastage); potential fo r better human health (though 
carcinogenicity not confirmed). 
Special points:   
Sectors (most relevant): Chemical s, energy, metals production. 
Geographical impacts:  Relevant industr ies (point sources) more prevalent  in some MS than others. Possible 
greater impact on ES aluminium producers if  still using the Söderberg technique.  
Uncertainties:  
Extent of failure of proposed EQS and MAC in so me MS.inclusion or not in REACH Annex XIV 
 
EN 98   EN  
HBCDD factsheet  
Proposal:  New priority substance Proposed status:  PHS 
Proposed critical EQS:  QS biota, sec pois   
Proposed corresponding EQS in freshwater:   167 µg/kg biota ww 
1.6 10-3 µg/l 
Rationale: 
Ranked high in modelling-based prioritisation; PBT, SVHC under REACH and included in Annex XIV of REACH, 
recommended POP, EU RAR conclusion of risk to aquatic environment.  
Main sources (produc tion, use etc):   
Industrial chemical, used as flame retardant in polymers:  insulation boards (Expanded PolyStyrene, eXtruded 
PolyStyrene), electronic equipment (High Impact PolyStyrene) , textile coatings (for furn iture etc.). Produced in NL, 
approx 6000 tonnes in 2005. Emissions to environment from all phases of life cycle. Approx half of total emissions 
are to wastewater from formulation. Estimated to be in 200 million homes.  
BASELINE  
Monitoring shows some exceedances of water and biot a EQS. REACH Annex XIV aut horisation required from 
August 2015; temporary authorisation for some uses likely . Eventual substitution, therefore decrease in emissions 
from new use, expected.  Possible POP designation (Stockholm Convention, CLRTAP) would also reduce 
emissions from new use. But emissions from old uses lik ely to continue, including from disposal of building 
materials in landfills, and HBCDD will persist in the environment. 
IMPACTS 
Costs:  
Mostly in baseline. Enhanced effluent  treatment at production sites. E nhanced waste water treatment costs and 
CO 2 emissions.  In the abs ence of alternative substance for use in  EPS/XPS, possible additional cost of 
alternative insulation materials. Possible safety issues if not equally fire retardant. HIPS alternative could mean + 
€4-5 per TV. Costs to current producer and at least 50 fo rmulators, including effects on employment (up to 30 000 
EPS/XPS jobs). Possible costs to users (at least 600) and consumers. 
Admin costs: Monitoring costs for MS, possi bly remediation costs (MS and/or industry). 
Benefits:  
Mostly in baseline. Better knowledge of water quality; re mediation if necessary, resulting in better water quality 
and ecosystem health; decreased scope for bioaccumulation, therefore potential for bette r biota health; potential 
for better aquaculture/fisheries/angling; improved consum er confidence (though could be lower confidence in the 
short term); potential for better human hea lth; stimulatio n of innovation;  benefits to producer s of alternatives 
including potential employment; employment in remediation work. 
Special points:   
Note: PHS designation consistent with approach under REACH. Most costs and benefit s expected to be realised 
under the baseline – dependent upon REACH Annex XIV authorisations; c ould be accelerated. 
Sectors (most relevant): Chemicals production, construction, electronic equipment, textiles. 
Geographical impacts: One production site in EU (NL), but  products produced at 50 sites throughout EU. Use 
lower in Scandinavia due to different national fi re regulations.  Benefits likely beyond the EU. 
Uncertainties:  
Possible authorised uses under Annex XIV of REACH; ti meline for availability of alternatives (none yet for 
EPS/XPS, though in pi peline); environmental and  health impacts of chosen alternatives; impacts of waste 
disposal route (incineration cf landfill). 
 
EN 99   EN  
Heptachlor factsheet  
Proposal:  New priority substance Proposed status:  PHS 
Proposed critical EQS:  QS biota, hh  
Proposed corresponding EQS in freshwater:   6.7 10-3 µg/kg biota ww 
2.1 10-7 µg/l 
Rationale:  
Ranked very high in monitoring -based prioritisati on; POP (Stockholm Convention); very toxic to aquatic 
organisms; risk ratio >1; possibly/probably carc inogenic to humans, possibly endocrine disruptive. 
Main sources (produc tion, use etc):   
Organochlorine insecticide.  Possibly (unlikely) residual (n on-authorised) use.  Otherwise  secondary release, e.g. 
by leaching from contaminated soils and sediments.  
BASELINE  
Monitoring shows evidence of failure of biota EQS in 3 MS and corresponding water EQS in at least 6 MS. Losses 
to water should decrease since no longer in Annex I of  Directive 91/414/EEC and use prohibited by Regulation 
(EC) No 850/2004. 
IMPACTS 
Costs:  
Possibly additional water-treatment  costs (to remove leached heptachlor), including energy/CO 2 emissions. 
Admin costs: Monitoring costs for MS.  Possibly sediment remediation costs. 
Benefits:  
Better knowledge of water quality; remediation if necessa ry, with potential for better water quality and better biota 
and human health; potential for better aquaculture/fisheries/angling. 
Special points:   
Note: Most benefits expected to be achieved under the baseline, but could be accelerated if monitoring results 
lead to remediation. 
Sectors (most relevant): None particularly beyond baseline. 
Geographical impacts: Most impacts alre ady in baseline; could be higher re mediation costs in MS with heavier 
previous use. 
Uncertainties:  
Extent of failure of proposed EQS in several MS in absence of sufficiently sensitive analytical method. 
 
 
EN 100   EN  
Lead factsheet  
Proposal:  Revised EQS taking account of 
bioavailability, for existing substance, Proposed status:  Unchanged (PS) 
Proposed critical EQS:  QS freshwater, eco   
Proposed corresponding EQS in freshwater:   
Proposed MAC: 1.2(fresh), 1.3(salt) (bioavai lable) µg/l (cf 7.2 µg/l) 
Not applicable 
14.25 µg/l 
Rationale: 
New information (EU VRAR 2008, SCHER review of VRAR 2009, first draft of Chemical Safety Report for REACH 
registration), and need to consider bioavailability. 
Main sources (produc tion, use etc):   
Production approx 1.5 million tonnes per annum in EU, consum ption slightly higher, value approx 3 billion Euros.  
At least 8 primary (from ore) production sites in at leas t 5 MS, approx 30 secondary (recycling) production sites in 
at least 12 MS. Production associated with mining/extra ction of other metals, especially zinc. Main uses: in 
batteries/accumulators, also in shot, boat keels, weight s, building materials (roofing), cable sheathing, glass, 
solder material, chemical compounds, some paints.  Value of use in EU: another 3 billion Euros/annum. 
Emissions to water highest from battery production, primary and secondary lead and sheet lead production 
(including mining), pulp/paper production, ferrous and non-ferrous metal processing, power generation, lead 
crystal glass production, plastic treatment, lead piping, wast e disposal including landfill and incineration. Also from 
diffuse sources: hunting/fishing, road ru n-off (tyres, vehicle exhausts), roof r un-off, soil erosion; and indirectly via 
atmospheric deposition (vehicular and industrial emissions to air, wildfires) (all of which may also enter surface 
water via UWWTPs). E-PRTR 2008 reports total EU emissi ons of lead to water of 135 tonnes from 586 facilities. 
BASELINE  
Eight MS report failure of current EQS in up to 2. 8% of freshwater bodies. Proposed EQS (bioavailable) 
effectively slightly more stringent than existing; complianc e likely to be similar (i.e. at approx 6 cf 7.2 µg/l total 
lead), though could be poorer where dissolved organic ca rbon (DOC) low.   Subject to control under several 
Directives and Regulations, including REACH, IPPC/IED, Drinking Water Directive, Gr oundwater Directive, WEEE 
Directive, Batteries Directive.  
IMPACTS 
Costs:  
Mostly in baseline. Possible increase in need for contro l measures (e.g. SUDs for run-off) and/or remediation 
at/near historic mining sites and/or other co ntaminated areas where DOC levels are low. 
Admin costs: Possible slight increase  in monitoring costs for some MS, i.e. those not already monitoring the 
parameters required to run biotic ligand models.  
Benefits:  
Many in baseline. Better water quality and ecosystem hea lth (lead is bioaccumulative and toxic); potential for 
improved aquaculture/fishing; potent ial for better human health/IQ; employme nt in control/remediation work. 
Focus on bioavailability likely to lead to better monitoring information, therefore also better targeting of control 
measures/remediation. 
Special points:   
Note: Lead is classified as Reprotoxic 1A, i.e. could be  considered a PHS on the grounds of an equivalent level of 
concern.  However, exposure of humans via surface waters is relatively low compared with exposure via other 
routes. 
Sectors (most relevant): Constructi on, mining, energy, sewerage/water. 
Geographical impacts:  Possibly greater costs in MS repor ting failure of existing EQS.  Possibly greater costs in 
MS with high number of facilities reporting high total emis sions to water, esp. FR, PL, UK, and/or in MS with 
higher percentage of lead communication pipes, e.g. FR, IE, UK (estimated cost of replacement in UK approx £8-
10 billion in 2005.) 
Uncertainties:  
Extent of failure of current EQS, and extent of variat ion in DOC (thus bioavailability of lead) across the EU. 
Effectiveness of lower lead standard in drinking water (10 µg/l) at reducing lead in domestic effluent.  
 
EN 101   EN Effectiveness of existing and possible additional measures at contributi ng to meeting the EQS. 
 
EN 102   EN  
Naphthalene factsheet  
Proposal:  Slightly more stringent EQS for freshwater, 
introduction of MAC for existing substance. Proposed status: Unchanged (PS) 
Proposed critical EQS:  QS freshwater, eco   
Proposed corresponding EQS in freshwater:   
Proposed MAC:  2.0 μg/l (cf 2.4 μg/l) (same for marine cf 1.2) 
Not relevant 
130 μg/l (cf none) 
Rationale: 
Review of the QSs prompted by revised RAR for pitch.  
Main sources (produc tion, use etc):   
Aromatic hydrocarbon.  Occurs natura lly in fossil fuels/derivatives and is produced during combustion; is therefore 
emitted from industrial processes using fossil fuels or involving combustion. Production (approx 200000 tonnes 
per annum in EU) from coal tar and petroleum for use as a chemical intermediate (in the production of plasticiser 
intermediates, pesticides and dyestuffs) mothballs, grindi ng wheels and pyrotechnics. Approx 25% exported.  
Also present in creosote, tar paints etc..  
Reported emissions to air and water (approx 192 and 190 t onnes respectively in E-PRTR 2008) highest from the 
energy sector (especially to water, mainly from oil drill ing/refining) and metals (including aluminium) production. 
Other emissions to water from wood treatment with cr eosote etc.  Emissions from incomplete combustion 
(including from vehicles, domestic fuel and agricultural burning, and wildfires) could lead to atmospheric 
deposition, but half-life in air short.  
BASELINE  
2 MS (RO, UK) report current failure of existing AA-EQS in  at least one water body. INERIS monitoring database 
reports no concentrations higher than proposed EQS or MA C. EU RAR calculates PECs that could locally exceed 
AA-EQS or MACs close to industrial point sources. Re gulation (EC) No 850/2004 on POPs imposes release 
reduction provisions; REACH Annex XVII restrictions. possib le inclusion in Annex XIV; IPPC Directive; Directive 
2004/107 on concentrations in air; Di rective 98/70/EC on PAH content of dies el; Directive 98/8/EC – restrictions 
on biocidal use; Directive 91/414/EEC excludes naphtha lene-based PPPs. Various BATs and BREFs, e.g. for 
aluminium production; Regulation (EC) No 1881/2006 on food standards for PAHs; inclusion in Annex I of 
Directive 98/8/EC effective from May 2013.  
IMPACTS 
Costs:  
Mostly in baseline, since little change in AA- EQS and no reported exceed ance of proposed MAC. 
Possibly additional measures directed at (industria l) point source emissions if MAC exceeded.  
Admin costs: None beyond baseline, except possibly additional permitting administration and additional targeted 
monitoring in the short term in relation to the MAC. 
Benefits:  
Mostly in baseline, but possible acceleration of lo cal improvements in water quality and ecosystem health. 
Special points:   
Sectors (most relevant): Chemical s, energy, metals production. 
Geographical impacts:  Producers located in AT, BE, DE, DK, ES, FR, IT, NL, UK. Could be more affected than 
other MS by any need for additional point-source controls in view of introduction of MAC. 
Uncertainties:  
Extent of failure of proposed EQS and MAC in so me MS. Inclusion or not in REACH Annex XIV 
 
 
EN 103   EN  
Nickel factsheet  
Proposal:  Revised EQS taking account of 
bioavailability, for existing substance, Proposed status:  Unchanged (PS) 
Proposed critical EQS:  QS freshwater, eco   
Proposed corresponding EQS in freshwater:   
Proposed MAC: 2 or 4 (fresh), 8.6 (salt) (b ioavailable) µg/l  (cf 20 µg/l) 
Not applicable 
34 µg/l 
Rationale: 
New information (EU RAR 2008, SCHER review of RAR 2009, additional industry studies related to REACH 
registration), and need to consider bioavailability. 
Main sources (produc tion, use etc):   
Production (from ore) approx 80000 tonnes per annum in EU (500 million Euros). Mined in 21 European 
countries. Used mainly (85% of "new" nickel) in alloys, al so in metal plating, batteries , pigments, other chemicals, 
steel production (especially stainless).  Products (wid e range, e.g. vehicles, domestic appliances and fittings, 
chemical plants, medical equipment) va lued at 40 billion Euros/annum in EU. 
Emissions to water (467 tonnes reported in E-PRTR for 2008) highest from industrial processes (including pulp 
and paper processing, electrolytic and chemical processe s), steel products in contact with water (including 
heating elements), waste disposal, mini ng.  Significant flow through UWWTPs. Emissions to air (350 tonnes in E-
PRTR for 2008) from combustion, some of which reaches wa ter by atmospheric deposition (directly and via soil). 
Inputs also from manure use in agriculture. Some di ffuse sources, e.g. urba n road run-off, pass through 
UWWTPs. 
BASELINE  
9 MS report failure of current EQS in up to 3.7% of rive rs. EQS (bioavailable) of 2 µg/l or 4 µg/l effectively more 
stringent than existing (i.e. at appr ox 5.6 or 11.2 cf 20 µg/l total dissolved Nickel, assuming standard dissolved 
organic carbon (DOC), pH and hardness), therefore failur es more likely, particularly in areas with low DOC. 
Estimated failure – up to approx 50% of monitoring sites in some MS at 2 µg/l . Nickel subject to control under 
several Directives and Regulations, including REACH, IPPC/IED, Drinking Water Directive, Groundwater 
Directive, WEEE Directive, Batteries Directive, but pr obably not sufficient to achieve revised EQS..  
IMPACTS 
Costs:  
Possible increase in need for control measures to r educe industrial Nickel emissions to UWWTPs especially 
where DOC levels are low (e.g. improved BAT; precipitat ion/reverse osmosis to treat effluent at source – 65% 
removal possible, capital cost per reverse osmosis unit  30,000 €, plus running costs).  Reduced Nickel usage in 
vehicle parts (tyres etc) and road surfaces. Possible replacement of domestic appliances. Possible additional 
treatment of landfill leachate (25-40% removal; cost per plant 90,000-1 80,000 €, plus annual running costs around 
35-100 €; additional water treatment at UWWTPs (£335 million per annum in UK for sand filtration and GAC), 
measures to reduce atmospheric emissions (low-sulph ur fuels, desulphurisation - £100-1000 million/tonne 
decrease), lime dosing of abandoned mines (£3.5 m illion capital cost, £1 million/annum to run). 
Admin costs: Possible slight increase  in monitoring costs for some MS, i.e. those not already monitoring the 
parameters required to run biotic ligand models.  
Benefits:  
Some in baseline, but stricter EQS likely to lead to bette r water quality and ecosystem health (nickel is toxic and 
can accumulate in soils/sediments), t herefore potential for improved aquacult ure/fishing. Focus on bioavailability 
likely to lead to better monitoring information, therefore also better targeting of cont rol measures/remediation.  
Benefits to human health mainly if measur es lead to decreased atmospheric emissions. 
Special points:   
Sectors (most relevant): Chemical s, domestic appliances, metal alloys, mining, energy, sewerage/water. 
Geographical impacts:  Possibly greater costs in MS repor ting failure of existing EQS.  Possibly greater costs in 
MS with high number of facilities reporting high total emissions to water, esp. FR, DE, IE, IT, UK. 
Uncertainties:  
Extent of failure of current EQS, and ex tent of variation in DOC, pH (thus bi oavailability of nickel) across the EU.  
Effectiveness of existing and possible additional measures at contributi ng to meeting the EQS. 
 
EN 104   EN  
PAHs factsheet  
Proposal:  Biota EQS as critical EQS for all but 
Benzo(g,h,i)perylene.  Corresponding water EQS more 
stringent than existing EQS.  MAC introduced for three 
PAHs; slightly changed for Benzo(a)pyrene. Revised 
EQS for Benzo(g,h,i)perylene slightly less stringent in 
freshwater, more stringent in saltwater. Proposed status: Unchanged (PHS) 
Proposed critical EQS:  QS biota, hh   
 
Proposed corresponding EQS in freshwater:   
Proposed MAC:  2 or 5 or 10 μg/kg biota ww (fish, crustaceans & 
cephalopods, molluscs, res pectively, in fresh and 
marine water); Benzo(a)pyrene as marker. 
1.7 10-4 ug/l 
Rationale: 
Review of the QSs prompted by revised RAR for pitch.  
Main sources (produc tion, use etc):   
Aromatic hydrocarbon.  Occurs natura lly in fossil fuels/derivatives and is produced during combustion; is therefore 
emitted from industrial processes using fossil fuels or in volving combustion. Not produced or used in pure form. 
Used through use of coal tar pitch, high temperature (CTPHT); production approx 800000 tonnes in 2004 in EU, 
small amount imported, more than one third exported. Main use in binding agents for e.g. electrodes, furnace 
lining materials (refractories), road construction, roofing.   Also present in creosote, tar paints, tyres etc..  
Reported emissions to water approx 10 tonnes in E-PRTR  2008, highest from metals production (particularly 
aluminium) and the energy sector (mainly from refini ng and combustion). Other emissions to water from 
production of basic organic chemicals, animal and ve getable products from food/ beverage industry, wood 
treatment with creosote etc.  Emissions  from incomplete combustion (including from vehicles, domestic fuel and 
agricultural burning, and wildfires) may lead to atmospheric deposition.  
BASELINE  
6 to 10 MS report current failure of existing AA-EQS  for some PAHs (most commonly Indeno(1.2.3-cd)pyrene and 
Benzo(g,h,i)perylene, in one or more water bodies. Ca lculated PECs in EU-RAR indicate that concentrations 
could be higher than proposed EQS and MAC. Regulation (E C) No 850/2004 on POPs imposes release reduction 
provisions; REACH Annex XVII restrictions. possible incl usion in Annex XIV; IPPC Directive; Directive 2004/107 
on concentrations in air; Directive 98/70/EC on PAH co ntent of diesel. Various BATs and BREFs, e.g. for 
aluminium production; Regulation (EC) No 1881/2006 on food standards for PAHs; inclusion in Annex I of 
Directive 98/8/EC effective from May 2013.  
IMPACTS 
Costs:  
Possibly additional measures directed at (industrial) point source emissions. Possible additional waste water 
treatment.  Possible costs related to changes in domestic fuel use. 
Admin costs: Possible change in monitoring costs due to sh ift to biota standards. Possibly remediation costs (MS 
and/or industry). 
Benefits:  
Better knowledge of water quality (due to switch to bi ota monitoring). Improvement in water quality; decreased 
scope for accumulation in the environment (binds to pa rticles), potential for better biota health and better 
aquaculture/fisheries/angling (including reduced wast age); potential for better human health (most PAHs are 
carcinogenic), though existing food standar ds should already be met and protective. 
Special points:   
Sectors (most relevant): Chemical s, energy, metals production. 
Geographical impacts:  Relevant industr ies (point sources) more prevalent  in some MS than others. Possible 
greater impact on ES aluminium producers if  still using the Söderberg technique.  
Uncertainties:  
Extent of failure of proposed EQS and MAC in so me MS. Inclusion or not in REACH Annex XIV 
 
EN 105   EN  
PBDE factsheet  
Proposal:  Biota EQS (and correspondingly more 
stringent water EQS) for existing substance, intended 
to cover additionally commerc ial octa BDE (BDE-197).  Proposed status:  PHS for tetra, penta, hexa and 
hepta BDEs   
Proposed critical EQS:  QS biota, hh   
Proposed corresponding EQS in freshwater:   8.5 10-3 µg/kg biota ww   
4.9 10-8 µg/l 
Rationale: 
Modelling-based prioritisation identified octa BDE (BDE-197)  as a priority.  EQS for the group of BDEs (hitherto 
for penta BDE (CAS 32534-81-9)) therefore reviewed to co ver octaBDE (CAS 32536-52-0) and take account of 
new information.  However, proposed EQS based on BDE 99 (penta derivative). Biota recognised as most 
appropriate matrix.  
Main sources (produc tion, use etc):   
Industrial chemicals, used as flame retardants. Only deca  BDE still used in EU – mainly as flame retardant for 
textiles (drapery, upholstery) and in non-electrical-equip ment-related polymers.  Not chemically bound. Emissions 
to environment (air, water, soil) from all phases of life cycle, therefore from formulation and new use of deca BDE 
products, and from use and disposal of existing produc ts, including furniture, upholstery, carpets, drapery, 
computers, televisions, automotive par ts (penta BDE particularly from flexible polyurethane foam, octa BDE and 
deca BDE from housings for electrical and electronic products).  Commercial deca BDE contains deca and nona 
BDE and a trace of the octa BDE derivative, and can debrominate. E-PRTR emissions to water mainly from textile 
factories and UWWTPs.  
BASELINE  
Five MS report current failure of existing standards. Penta and octa BDE subject to restricted use under 
Regulation (EC) No 552/2009 – use effectively banned in  EU since 2004. POP designation (Regulation (EC) No 
850/2004) for tetra, penta, hexa, and h epta derivatives since 2010. Deca BDE banned in electrical and electronic 
equipment since 2008 (Directive 2002/ 96/EC); other uses cont inue; not produced in EU, but imported (60k tonnes 
produced worldwide in 2007). Alternatives exist. Disposa l controlled by WEEE direct ive. Limits in waste being 
proposed.  Voluntary control (VECAP)  for industrial emissions. Possible inclusion of penta and octa BDEs in 
Rotterdam Convention. 
IMPACTS 
Costs:  
Mostly in baseline.  
Possibly enhanced waste water treatment costs and CO 2 emissions to meet lower EQ S. More stringent treatment 
of landfill leachate.  
Admin costs: Possible slight change to monitoring costs (shift from water to biota monitoring) for MS; possibly 
increased identification of sites for remediation. Possibl y costs of scheme(s) to remove products from use (though 
such schemes unlikely). 
Benefits:  
Most in baseline. Better water quality and ecosystem health; decreased scope for bioaccumulation, therefore 
potential for better biota health; potential for better aquacul ture/fisheries/angling; impr oved consumer confidence; 
potential for better human health; employment in remediat ion work. Biota monitoring could improve quality of 
monitoring information, therefore also  the targeting of remediation. 
Special points:   
Note: PHS designation of penta BDE (technical/commercia l mixture) consistent with approach under Stockholm 
convention. Most costs and benefits expec ted to be realised under the baseline. 
Sectors (most relevant): Textiles, sewerage/water. 
Geographical impacts:  Possible impacts on producers out side EU if need to meet lower EQS for lower 
brominated congeners leads to restrictions on us e of deca BDE. Benefits likely beyond the EU. 
Uncertainties:  
Extent of failure of EQS in MS due to inadequate analytical sensitivity. 
 
 
EN 106   EN  
PFOS factsheet  
Proposal:  New priority substance Proposed status:  PHS 
Proposed critical EQS:  QS biota, sec pois   
Proposed corresponding EQS in freshwater:   9.1 µg/kg biota ww 
6.5 10-3 µg/l 
Rationale: 
Annex III substance, PBT, POP, risk ratio >1  
Main sources (produc tion, use etc):   
Industrial chemical, not produced in EU.  Used in fire-fig hting foams (residual use due to end 2011), coatings in 
photography and photolithography (sem i-conductors), wetting agents in electroplating (until 2015), mist 
suppressants in chromium plating, and hydraulic aviation  fluids.  Possible emissions from use/disposal of old 
products (carpets, textiles), and from soils/sewage sludge/sediments.  
BASELINE  
Monitoring database contains data from 3 MS and NO, all showing exceedances of proposed EQS. REACH 
(Annex XVII) derogations for some uses.  However, grad ual substitution, therefore decrease in emissions from 
new use, expected.  POP designation (Stockholm Convention) should also reduce emissions from new use. But 
emissions from old uses likely to continue, and PFOS will persist in the environment. 
IMPACTS 
Costs:  
Remediation of soil/sediment and/or en hanced waste water treatment costs and CO 2 emissions.  Possible earlier 
development costs for alternatives in p hotography, photolithogr aphy, aviation. In the absence of alternatives, cost 
of phasing out emissions to water could be disproportionate. 
Admin costs: Monitoring costs for MS, possi bly remediation costs (MS and/or industry). 
Benefits:  
Better knowledge of water quality; remediation if necessary, resulting in better water quality and ecosystem 
health; decreased scope for bioaccumulation, therefore potential for better biota health; potential for better 
aquaculture/fisheries/angling; improved consumer conf idence; potential for better human health (workers, 
consumers); stimulation of innovation; pot ential employment in remediation work. 
Special points:   
Note: PHS designation consistent with approach under REACH. Many benefits expected to be achieved under 
the baseline, but could be accelerated. 
Sectors (most relevant): Aviation industry. Semi-conductor industry. 
Geographical impacts: Probably no differences in EU. Possible impact on China (only producer).  
Uncertainties:  
Spatial distribution of PFOS in environment; extent of fa ilure of EQS; timeline for availability of alternatives. 
 
 
EN 107   EN  
Quinoxyfen factsheet  
Proposal:  New priority substance Proposed status:  PHS 
Proposed critical EQS:  QS freshwater, eco  
Proposed corresponding EQS in freshwater:   0.15 µg/l 
- 
Rationale:  
Annex III substance; PBT properties. 
Main sources (produc tion, use etc):   
Use as PPP (fungicide), pr edominantly on cereals and gr ape vines, thence losses to water by way of spray-drift, 
run-off, spills. Otherwise secondary rele ase, e.g. by leac hing, from contaminated so ils and sediments. EU sales 
68 000 kg/yr.  
BASELINE  
Limited monitoring data (2 MS) shows isolated exceedan ce of EQS in FR, but author ised in 17 MS, therefore 
uncertainty regarding other MS. Losses to water could decrease with introduction of National Action Plans for 
PPPs under the Sustainable Use of Pesticides Direct ive; current authorisation under Directive 91/414/EEC 
acknowledges need to limit risk to aquatic environment; exclusion from Annex I of that Directive would be 
expected to follow after review of authorisation in 2014 given position in Regulation (EC) No. 1107/2009 on not 
authorising PBTs, if PBT properties confirmed. 
IMPACTS 
Costs:  
Costs to one (major agrochemical) producer and formulato rs/retailers unless can provide substitute products.  
Costs to users if substitutes more expensive.  Possib le concern regarding resistance of powdery mildew to 
alternatives, although several alternatives are authoris ed (Entec 2011, ADAS 2010, HG CA 2009). Fewer of them 
may be suitable for hops than for other crops. 
Admin costs: Monitoring costs for MS. 
Benefits:  
Better knowledge of water quality; potential for bette r water quality and biodiversity, better biota and human 
health, aquaculture/fisheries/angling. 
Special points:   
Sectors (most relevant): Agro chemicals, Arable farming. 
Geographical impacts: Impacts particularly on farmers in DE , ES, FR, IT (highest sales in these MS); possibly on 
employment if production localised; US- based company but location of production of active substance not known.; 
at least 6 formulators/markete rs in FR, 3 in UK. (case-study MS); no data for other MS. 
Uncertainties:  
Extent of failure of proposed EQS in several MS in abs ence of widespread monitoring.  Possibility of decrease in 
use under baseline because of resistance. 
 
 
EN 108   EN  
Terbutryn factsheet  
Proposal:  New priority substance Proposed status:  PS 
Proposed critical EQS:  AA-EQS freshwater,eco  
Proposed corresponding EQS in freshwater:   0.065 µg/l 
Not relevant 
Rationale:  
Ranked high in modelling based prioritisation, medium in monitoring-based prioritisation, toxic, risk ratio >1 
Main sources (produc tion, use etc):   
Biocidal (algicidal) use - approx 200 tonnes/yr in EU - especially in coatings on buildings, from which run-off 
occurs.  
BASELINE  
Monitoring data from 9 countries shows exceedances of EQ S in 4 MS and CH. Losses to water could be lower in 
coming years because no longer in Annex I of Directi ve 91/414/EEC (2003 and 2007 staged withdrawal of 
herbicidal use authorisation in different  MS).  Uses as preservative for film, wood, masonry currently being 
reviewed under the Biocidal Products Directi ve 98/8/EC; outcome could affect baseline. 
IMPACTS 
Costs:  
Installation and maintenance of sustainable urban drai nage systems (SUDs) (variable depending upon type). 
Possible enhanced waste water treatment. 
Admin costs: Monitoring costs for MS. 
Benefits:  
Better knowledge of water quality; feedback to the bioci dal products authorisation process.  Possible benefits to 
biodiversity, and to angling. Reduced risk of failure of dr inking water standards. SUDs could have shared benefits, 
e.g. flood control, energy saving.  Stim ulation of innovation in construction to  minimise need for biocidal coatings. 
Special points:   
Note: Some benefits expected to be achi eved under the baseline, but not all MS have SUDs in place to capture 
run-off in urban areas, and this could lead to impr ovements, as could changes in pattern of use. 
Sectors (most relevant): Construction, Coatings 
Geographical impacts:  Marketed by two companies in EU. Products formulated in various MS, including LV; 
active substance produced at least partly outside EU. 
Uncertainties:  
Extent of failure of EQS now that no longer us ed as herbicide.  Availability of substitutes. 
 
 
EN 109   EN  
Trifluralin factsheet  
Proposal:  New status for existing substance Proposed status:  PHS 
Proposed critical EQS:  Unchanged   
Proposed corresponding EQS in freshwater:   As in existing EQS Directive 
 
Rationale: 
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. 
PBT criteria met even if POP designation not confirmed. (P  criterion for PBT is less st ringent than for POP, i.e. 
120d cf 180d in soil). 
Main sources (produc tion, use etc):   
Possibly residual (non-authorised) use as PPP (herbicide),  thence losses to water by way of spray-drift, run-off, 
spills. Possible isolated emissions via UWWTPs due to reco very/disposal of hazardous waste (data for ES and IT 
in E-PRTR 2007, 2008). However, no longer authorised for use in EU.  Possible emissions from production (for 
export) in HU, though none reported in E-PRTR. Possible se condary release, e.g. by leaching from contaminated 
soils and sediments.  
BASELINE  
Current failure of EQS in CY, ES, HU, IT, NL, RO, SK. No  further primary emissions fr om use expected at present 
(authorisation under Directi ve 91/414/EEC withdrawn in 2009). Any emis sions from production in HU would have 
to cease if POP designation agreed.  Possibly se condary emissions from disturbed sediments. 
IMPACTS 
Costs:  
Possible cost to producer in HU if production for ex port had to cease, with possible loss of jobs unless 
redeployment possible – though these costs wo uld be in baseline if designated as POP. 
Admin costs: Possibly remediati on costs (MS and/or landowners). 
Benefits:  
Remediation if necessary, with potential for better wate r quality and better biota and human health; potential for 
better fisheries/aquaculture/angling. 
Special points:   
Note: PHS designation consistent with latest scientific  information and approach under PPP legislation.  Some 
impacts would be in baseline if POP designation agreed. 
Sectors (most relevant): Agrochemicals, Arable farming 
Geographical impacts: Possible impact in HU if production causes emissions, as production would have to cease.  
Impacts otherwise greatest in MS where use was greatest and/or exceedance of EQS is  observed, if remediation 
proves necessary. 
Uncertainties:  
Extent of contamination of soils/sediments and secondary emissions.  POP designation. 
 
 
 
 
EN 110   EN ANNEX VI: Description of the main policies af fecting the baseline an d interactions with 
the WFD  
 
Implementation of the WFD: measures in  river basin management plans (RBMPs) 
The 13 existing substances that have been as sessed are already includ ed as PS or PHS in 
Annex X of the WFD, with EQSs listed in Annex I of the EQS Directive.  For these 
substances, measures should already have be en identified and their implementation be 
underway or planned where failures of the EQS o ccur.  The approach to achieving phase-out 
of emissions of PHS should also be under consideration. 
For all existing substances there are existing EU measures. Measures sheets have been 
compiled for all of them. See factsheets in Annex V for summary information.   
One of the difficulties involved in assessing the impacts of a change to an existing substance 
is to understand the exte nt to which MS intend to undert ake measures, the detail of those 
measures, and their likely eff ectiveness. The WFD requires MS  to adopt and publish RBMPs 
and programmes of measures in December 2009. 20 MS have adopted plans and programmes 
at the time of writing this impact assessment re port. Another 3 are expect ed to adopt them in 
2011. The remaining 4 are expected to have longer delays.  
Once the plans and programmes are adopted, th e WFD gives MS until December 2012 at the 
latest to make operational the measures. This means the details about implementation of the 
measures are being developed at the moment. This leads to considerable uncertainty in 
assessing the ultimate effectiveness of measures.   
In addition to substance-specific measures , another source of uncer tainty stems from a 
number of generic measures that are included in the programmes of measures that aim to 
improve water quality and/or re duce concentrations of certain types of pollutants in the 
environment.  These are relevant to both exis ting and proposed substances.  For example, the 
study by EcoLogic and ACTeon (2010) which review ed agricultural measures in WFD draft 
programmes across Europe identifies some of these measures.  This provided information 
relevant to proposed substances including gene ral information on PPP policies and trends, and 
information on diffuse nutrient po llution that could contribute to wards addressing substances 
such as 17 beta-estradiol (e.g. measures to reduc e nutrient input to rive rs, such as preventing 
cattle reaching river banks).   
There are also a range of measures to address wa ter quality that are not specific to a substance 
and will provide overall improvements, while at the same time contributing towards compliance of specific substances (i.e. incl uding the existing and proposed substances 
assessed here).  Such measures include: 
• Improved wastewater treatment; 
• Addressing urban runoff (both water qua lity and flood risk) through use of 
Sustainable Urban Drai nage Systems (SUDS); 
• Measures to address morphology pressure, including improving riparian habitats; 
 
EN 111   EN • Measures to address rural diffuse pollution (particularly reductions in nitrogen and 
phosphorus inputs), for example by cont rols on manure spreading, preventing 
cattle reaching river bank s, general PPP measures. 
While not necessarily targeted at particular existing or proposed s ubstances, over time these 
measures have the potential to contribute towards achieving the EQSs of a range of 
substances. 
Some of the proposed substances are explicit ly considered by some MS, where they are 
defined as Specific Pollutants.  This means that the relevant MS are already committed to monitoring the substance and addressing any failure s of the (existing) EQS.  However as the 
EQS is self-defined by the MS, it may still be necessary for the MS to  undertake further work 
if the substance were to be defined as a PS/PH S, potentially with a more stringent EQS.  
Information collected from WG E representative s to the Commission (note that not all MS 
provided information) indicates that 10 of the 15 pr oposed substances are already included as 
specific pollutants in at least one MS.  Heptach lor, PCBs, and Dioxins are the most commonly 
monitored, probably as a result of oblig ations under the Stockholm Convention. 
Substance MS including the substance as specific pollutant Number of MS 
Aclonifen SE (0.2 µg/l; 0.1 mg/kg sediment) 1 
Cybutryne SE (0.003 µg/l in marine water; 0.0002-0.0008 mg/kg dw) 1 
Cypermethrin DK (1 µg/kg in river or lake sediment)   
UK (0.1 ng/l annual mean; 0.4 ng/l 95th percentile) 2 
Dichlorvos BE (0.0007 µg/l average, 0.007 µg /l MAC), IT (0.01 µg/l), NL (0.0006 
µg/l), IE (monitored but no EQS), DE (0.0006 µg/l) 5 
Dioxins (and DL-PCBs) DK (between 0.0 0005-0.0001 µg/kg WW in marine bivalves; 
between 0.1-0.2 µg/kg WW in marine sediment; between 0.0002-
0.0004 µg/kg WW in marine fish),  
IT (sum T.E. PCDD, PCDF and PCB dioxin-like): 0.002 µg/kg dw 
SE (0.9 ng TEQ fish/kg; 8 pg TEQ mammals/g) 
IE (monitored but no EQS) 4 
HBCDD DK (0.2 µg/kg WW marine fish) 
SE (0.3 µg/l in freshwater, 0.03 µg/l in marine water; 0.9 mg/kg 
sediment; 1.5 mg/kg biota) 2 
Heptachlor AT (0.004 µg/l),  BE (0.009 µg/l average; 0.09 µg/l MAC),  IT (0.005 
µg/l),  RO (0.0002 µg/l), CY (monitored but no EQS), IE (monitored 
but no EQS), NL (0.0005 µg/l), DE (0.1 µg/l) 8 
PFOS DK (0.2 µg/kg WW marine fish)  
CZ 25 µg/l  
SE (30 µg/l in freshwater; 3 µg/l in marine water; 0.006 mg/kg biota) 3 
Terbutryn CZ (0.1 µg/l), BG (0.01 µg/l) 2 
Based on WISE electronic submission from 19 MS (AT, BE, BG, CZ, DE, EE, FI, FR, HU, IE, IT, LT, LV, NL, PL, RO, SE, 
SK and UK) plus data from ENTEC (2011) for DK and CY  
In summary, there is considerable uncertainty  regarding the impact that the WFD programmes 
of measures will have in reducing the emissi ons of existing and proposed PS, and ultimately 
in reducing their presence in the environment.  
 
 
EN 112   EN Plant Protection Products 
Active substances may only be included in PPPs in the EU if they are authorised by inclusion 
on Annex I of Directive 91/414/EEC (regardi ng placement of PPPs on the market).  
Individual active substances can be added to A nnex I by individual directives which, in some 
cases, include requirements or restrictions on us e of the substance (for example requirements 
to leave a buffer zone around surface water bodies). 
Directive 91/414/EEC will be replaced by Regulation (EC) No 1107/2009 in June 2011 which 
maintains the authorisation of ac tive substances at EU level.  
Directive 2009/128/EC, establishing a framew ork for community action to achieve the 
sustainable use of pesticid es, will be implemented from  2011.  The directive includes 
measures to:  
• Include instructions on safety, storage a nd disposal of pesticides with sales; 
• Improve public awareness of possible risks from the use of pesticides; 
• Promote research programmes aimed at de termining the impacts of pesticide use 
on human health and the environment; 
• Provide systems for regular inspection of pesticide application equipment. These 
must commence by 2016 and be carried out at  least once every five years, and a 
certification programme put in place; 
• Generally prohibit the use of aerial sp raying (from a plane or helicopter) of 
pesticides (although dero gations are possible); 
• Take measures to avoid pollution of the aquatic environment, such as using the 
most efficient application techniques, establishing buffer strips, planting hedges 
along waterbodies, and reducing or elimina ting use in areas with a high likelihood 
of runoff of surface water or se wers (e.g. roads and railways); 
• Promote low-pesticide pest management  methods (including integrated pest 
management and organic farming); 
• Minimising or prohibiting us e of pesticides in sensitive areas including Natura 
2000 sites and public spaces (such as parts or sports grounds). 
All of these measures must be implemented in National Action Plans, which are to be 
communicated to the Commission by 14 December 2012.  As the plans have not been produced yet, there is some uncertainty about th e exact measures that will be put into place, 
but the directive clearly has the potential to reduce concen trations of PPPs in water. 
The Directive complements well the action under  the WFD but does not replace it.  The EQS 
under the WFD provide a benchmark for assessing whether measures are effective, and the 
WFD focuses on PPPs that have been identified as posing a risk to the aquatic environment. 
The substances that are included in the polic y options and that ar e concerned by the PPP 
legislation are Trifluralin, Dicofol, Qu inoxyfen, Aclonifen, Bifenox, Cypermethrin, 
Dichlorvos, Heptachlor and Terbutryn. 
 
EN 113   EN Biocides 
Directive 98/8/EC on the placing on the mark et of biocidal products aims to: 
• Harmonise the European market for biocid al products and thei r active substances; 
• Provide a high level of pr otection for people, anim als and the environment 
through risk assessment; 
• Ensure products are sufficiently e ffective against the target species. 
Active substances that are authorised for use are placed on to Annex I of the directive.  
However the review programme, i.e. the approv al for placing on Annex I, is still ongoing.  
The review covers 23 different product type s including, for example, disinfectants, 
preservation products, non-agricu ltural pesticides, and anti-f ouling products.  It does not 
include PPPs, which are cove red under Directive 91/414/EEC. 
A Commission proposal (COM(2009) 267) to repl ace Directive 98/8/EC is currently under 
negotiation.  The regulation aims to improve the f unctioning of the internal market in biocidal 
products while maintaining the hi gh level of the environmental and human health protection.  
As under Directive 98/8/EC there would be a two-tiered authoris ation process: inclusion of 
the active substance in Anne x I, followed by authorisati on of the biocidal product. 
The substances that are included in the policy options and that are concerned by the biocides 
legislation are Cybutryne, Cypermet hrin, Dichlorvos and Terbutryn. 
Persistent organic pollutants 
The Stockholm Convention on Persistent Organic Pollutants is a global treaty to protect 
human health and the environment from chemicals that remain intact in the environment for long periods, become widely distributed geog raphically, accumulate in the fatty tissue of 
humans and wildlife, and have adverse effects to  human health or to the environment.  The 
Stockholm Convention was adopted in 2001 and entered into force in 2004.  It required 
parties to take measures to eliminate or reduc e the release of POPs into the environment.  
There were twelve original POPs, including pe sticides, industrial chemicals and by-products.  
In 2009, nine additional chemicals were added to  the annexes of the Stockholm Convention.  
There are three classifications: 
• Annex A (elimination): parties must take  measures to eliminate the production 
and use of the chemicals listed under Annex A.  In some cases, specific 
exemptions for ongoing use or production may be made; 
• Annex B (restriction): parties must take measures to restrict the production and 
use of the chemicals listed under Annex B in light of any applicable acceptable 
purposes and/or specific exem ptions listed in the Annex; 
• Annex C (unintentional production): partie s must take measures to reduce the 
unintentional releases of chemicals li sted under Annex C with the goal of 
continuing minimisation and, where feasible, ultimate elimination. 
The convention is implemented in the EU  through Regulation (EC) No 850/2004.  The 
regulation complements earlier Community legi slation on POPs and aligns it with the 
provisions of the international agreement.  The regulation contains provisions regarding 
 
EN 114   EN production, placing on the market and use of ch emicals, management of stockpiles and 
wastes, and measures to reduce unintentional rele ases of POPs. Furthermore, MS must set up 
emission inventories for unintentionally pr oduced POPs, national implementation plans 
(NIPs) and monitoring and info rmation exchange mechanisms. 
The WFD mechanism can ensure monitoring of th ese substances in the aquatic environment 
and facilitate progress towards the cessation/phase- out objective.  It has been recognised that 
under the Stockholm and UNECE LRTAP Conven tions “there is a general lack of 
coordinated monitoring or re gional surveys that focus on POPs in the freshwater 
environment”49. 
The following substances relevant to this  assessment are included under the Stockholm 
Convention: Heptachlor, Dioxins, PCBs, some  polyBDEs (tetraBDE, pentaBDE, hexaBDE, 
heptaBDE) and PFOS.  
REACH 
Regulation (EC) No 1907/2006 deal s with the Registration, Ev aluation, Authorisation and 
Restriction of Chemical Substan ces (REACH). It entered into force in June 2007.  The aim of 
REACH is to improve the protection of human health and the envir onment through the better 
and earlier identification of the intrinsic proper ties of chemical substances.  The regulation 
required manufacturers and importers to gath er information on the properties of their 
chemical substances, and to register the information in a central database. 
The elements in REACH include: 
• All substances are covered by the REACH regulation unless they are explicitly 
exempted;  
• Registration requires manufacturers and impor ters of chemicals (1 tonne or above 
per year) to obtain relevant information on their substances and to use those data 
to identify and apply the appropriate risk manageme nt measures. Substances not 
included include those that are regulat ed elsewhere (e.g. PPPs, biocides and 
medicinal products), those present at very low risk, or those o ccurring in nature 
that have not been chemically modified (e.g. minerals, ores); 
• Substances of very high concern may be included in the Candidate List and may 
be made subject to authorisation (inclusi on in Annex XIV).  For these substances 
to continue to be used, applicants will ha ve to demonstrate that risks associated 
with uses of each substance are adequately  controlled or that the socio-economic 
benefits of their use outweigh the risks.  Applicants must also analyse whether 
there are safer suitable alterna tive substances or technologies. 
                                                 
49  Global Monitoring Plan for Persistent Organic Pollutants under the Stockholm Convention Article 16 
on effectiveness evaluation. First regional monitoring report Western Europe and other groups Region 
(2008). http://chm.pops.int/Portals/0 /Repository/GMP/UNEP-POPS-G MP-RMR-WEOG.English.PDF  
and UN-ECE Convention on Long-Range Transboundary Air Pollution. Working Group on Effects. POPs in the Freshwater environment: Effects of long-range transboundary air pollution. 
EB.AIR/WG.1/2005/6 (2005). 
http://www.unece.org/env/documents/200 5/eb/wg1/EB.AIR.W G.1.2005.6.e.pdf
   
 
EN 115   EN • Restrictions can be placed on the manuf acture, marketing or use of particular 
substances. 
DEHP and HBCDD have been added to REAC H Annex XIV for authorisation (February 
2011).  
Other substances included in this assessment are being considered for authorisation.  This 
includes Anthracene (and related oils, pastes) an d coal tar pitch high temperature (relevant to 
PAHs, Anthracene, Fluoranthene, Naphthalene).  If these substances are indeed added to Annex XIV, then, depending on the outcome of the authorisation process, the baseline for 
these substances could change substantia lly. In any case the WFD will monitor the 
concentrations of these substances in the a quatic environment and, in the case of PAHs and 
Anthracene, progress towards the cessation/phase-out objective. 
The substances that are included in the polic y options and that are concerned by REACH are 
Anthracene, BDE, DEHP, Lead, Naphthalene , Nickel, PAH, Fluoranthene, PFOS and 
HBCDD.  
Industrial emissions 
The Directive on Industrial Emissions (D irective 2010/75/EC) re casts seven existing 
Directives relating to industrial emissions into a single coherent legislative instrument.  The 
recast covers the Integrated Pollution Prev ention Control (IPPC) Directive, the Large 
Combustion Plants Directive, the Waste Inci neration Directive, the Solvents Emissions 
Directive, and three Directives on Titanium Di oxide.  The directive has been developed to: 
improve implementation of BAT; reduce li mitations of compliance enforcement and 
environmental improvements; reduce unnecessary administrative burden; improve scope and provision to achieve Thematic Strategy objectives of air, waste and soil. 
The Directive uses the concept of Best Ava ilable Techniques (BAT).  Emission limits and 
operating conditions contained in  the IPPC authorisation perm its are based on BAT, taking 
into account the technical charac teristics of an installation, its geographic location and the 
local environmental conditions.  BAT refere nce documents (BREFs) are produced by the 
European IPPC-Bureau for each sector.  
Potentially all substances are concerned by the industrial emissions dire ctive, although those 
that are not produced or ar e only formulated in the EU may not be concerned. 
Pharmaceutical legislation 
The approval process for medi cinal products for human use is described in Directive 
2001/83/EC (Directive of the Eu ropean Parliament and of the Council on the Community 
code relating to medicinal products for human us e) and further amendments. In this directive, 
the basic parameter for approval is a positive risk/benefit evaluation of the product, which 
includes a safety and efficacy assessment. As a further parameter, the “potential environmental risk posed by the medicinal pr oduct” should be assessed “and, on a case-by-
case basis, specific arrangements to limit it shall be envisaged.”(EU Directive 2004/27, 
Article 8 (3b)). In any event, environmental im pact cannot constitute a criterion for refusing 
marketing authorisation for a human medici nal product. However, it is a criterion for 
veterinary medicinal products.  
 
EN 116   EN For existing pharmaceutical products for human use there is no obvious mechanism to revise 
marketing authorisations on the basis of the environmental impacts. 
There is a commitment by the Commission to look at the environmental impact of 
pharmaceuticals. A study will be  launched in 2011 which will build on a large range of 
studies and information available50. Impact of this Commission initiative in the longer term is 
uncertain at the moment. 
The substances that are included in the pol icy options and that are concerned by the 
pharmaceuticals legislation ar e EE2, E2 and Diclofenac. 
Waste legislation 
Waste legislation covers a large share of th e entire EU environmental acquis and includes 
thirteen main legislative acts adopted by the Eu ropean Parliament and the Council and a large 
number of related decisions adopted through com itology procedures. The ove rall scope of this 
legislation is the prev ention or reduction of waste production, the re-u se, the recycling, other 
types of recovery than recycling and the disposal of different categories of waste; permitting and control of disposal operations, mainly landf ills; and shipments of waste within the EU as 
well as to and from third countries.   
The basic requirements are la id down by the Waste Framewor k Directive 2008/98/EC which 
is complemented by specific legislation addressi ng particular environmental threats associated 
with waste. This specific legislation incl udes harmonised rules on waste management 
practices, including strict emi ssion limits and operat ing requirements for the incineration and 
landfill of waste; harmonised rules on shipments  of waste; and product sp ecific  legislation 
setting targets for collection,  re-use, recovery and recy cling and introducing producer 
responsibility principles for specific waste  streams derived from consumer goods, in 
particular packaging waste, end of life vehicl es, waste electrical a nd electronic equipment, 
mining waste and batteries. 
The latest Commission implementation re port COM(2009)633 recognises progress on the 
implementation of the waste legislation but also important implementation gaps. Further 
progress in the coming years may have an importa nt influence on the baseline for some of the 
substances identified under the review, as important emissions to water may be generated by 
waste handling and/or disposal. 
Interactions of main upstream policies with the WFD 
Existing policies at EU level,  at least for industrial chemi cals, PPPs and biocides, include 
appropriate mechanisms that can  be used to develop process and product controls to address 
the risks identified by the WFD.  
• Emission controls are best su ited to reducing, where necess ary, the emissions of PS.  
However, they may also be appropriate to control the emissions to water of PHS of 
natural origin or those pr oduced unintentionally, which it  may not be possible to 
eliminate completely. In the context of the 2006 proposal the Commission stated that 
there were already a number of pieces of EU  legislation that set emission controls for 
                                                
 
50  Roig B, 2010; EEA, 2010; SRU, 2007; Swedish Medical Products Agency, 2009; Apoteket, 2006; 
CGEDD, 2010. 
 
EN 117   EN point sources (notably the Urban Waste Wa ter Treatment Directive and the IPPC) and 
concluded that additional emission controls were best developed and implemented at 
MS level. This conclusion is still valid. 
• Product controls, such as limits on production or use, appear to be best suited to the 
cessation and phase-out objective for PHS alt hough they may also be useful to reduce 
emissions from a particular use, e.g. by restri ction. A range of tools is already available 
in the EU legislation: 
o Under REACH, the evaluation, restri ction and authorisation processes 
o Under the PPP legislation, the evaluation, restriction and authorisation processes 
and periodic review 
o Under the biocides legislation, the ev aluation, restriction and authorisation 
processes and pe riodic review 
o Under the pharmaceuticals legislation, th e authorisation and review processes 
for veterinary medicines. 
One of the main objectives of these EU legislative instruments is to prevent the placing in the 
market of substances that may cause unaccepta ble risks. PPPs and biocides require risk 
assessment prior to authorisati on. Industrial chemicals need to be registered under REACH, 
including a chemical safety assessment. If the latter shows the need to limit the risks, the 
registrant is required to take and recomme nd adequate risk manage ment measures. Where 
registration alone is not sufficien t to manage the risks, restri ction or authorisation may be 
used. 
The WFD identifies PS by assessing the risks to  the aquatic environment, largely relying on 
monitoring information. The WFD pr ioritisation process acts as a sa fety net to ensure that the 
assumptions and results of the risk assessments ca rried out for placing in the market of certain 
substances under other legislation, including a ny mitigation measures that are applied, are 
actually delivering adequate prot ection of water resources and of  human health via the aquatic 
environment. The WFD can also identify substan ces posing a risk that have been in use for 
many years, in some cases without having been  subjected to a proper risk assessment. The 
WFD can then feed back to these upstrea m policies the information gathered that 
demonstrates unacceptable risks, for these po licies to act according to their established 
procedures.  
As regards the pharmaceutical legislation, since 2004 it requires applications for the 
authorisation of new products to be accompan ied by an Environmental Risk Assessment. 
However, the results of this assessment are not considered in the risk-b enefit balance that is 
the basis of the authorisation for human medici nes, though it is for veterinary medicines. As 
regards human pharmaceuticals authorised be fore 2004, there is no mechanism in the 
legislation to address environmental impacts. 
The diagram on the following page illustrates the interaction of some of the main upstream 
policies regulating the use and placing on the market of s ubstances (i.e. REACH, PPPs, 
biocides, pharmaceuticals) with the WFD prio rity substances process. The white boxes 
indicate WFD processes. The potenti al role of the watch list as per options C in the text is also 
included.  
The central vertical process describes the ma in steps of the WFD prioritisation exercise, 
including a risk assessment step  that uses data on substances  exposure and effects. Upstream 
 
EN 118   EN policies constitute an important source of data for the WFD prioritisation exercise and on the 
other hand they also benefit from the m onitoring data gathered under the WFD.  
Interactions with other policies (waste, industrial emissions) are not included in the diagram. 
 
 
EN 119   EN PrioritisationExposure data Effects dataUniverse of chemicals•International lists
•REACH, pesticides, biocides, 
pharmaceuticals
•Research
•Emerging pollutants
•Substances of concern for 
Member States
Outcome of prioritisation:
•Candidate list of substances
•List of substances not prioritised 
due to lack of information
Expert Group 
assessment
New Priority 
SubstancesList of substances
for which more 
information is needed
REACH dossier
REACH 
restrictionREACH 
authorisationPPP active substance 
authorisation review 
Art. 21 Reg 1107/2009Biocide active substance 
authorisation review 
Art. 10(4) Dir. 98/8/ECREACH 
registration
PPP active substances 
authorisation dossiers
Biocides active substances 
authorisation dossiersMember States 
monitoring data
Watch list
REACH 
evaluationPharmaceuticals ERA
authorisation dossiers
Legend: Policy processes
Exchange of information and/or triggers for action between policies
 
 
 
EN 120   EN ANNEX VII: List of stakeholders  involved in the consultation  
List of stakeholders members of th e Working Group E on Chemical Aspects  
Organisation Sector 
ECPA (European Crop Protection Association) Pesticides 
Business Europe Business organisation 
AESGP (Association of the European Se lf-Medication Industry) Pharmaceuticals 
AISE (International Association for Soaps, Dete rgents and Maintenance Products) Detergents 
CEPI (Confederation of European Paper Industry) Pulp and paper 
CONCAWE (European Oil Companies' Asso ciation for Environment, Health and 
Safety in Refining and Distribution) Oil  
EFPIA (European Federation of pharmaceuticals In dustries and Associations) Pharmaceuticals 
EUCETSA (European Committee of Environmental Technology Suppliers 
Association) Equipment suppliers 
EUDA (European Dredging Association) Dredgers 
Greenpeace Environmental NGO 
Commission OSPAR International Convention 
Secretariat 
COPA-COGECA (Committee of Agricultural Organisations in the European 
Union - General Committee for Agricultural Co-operation) Agriculture 
EEB (European Environmental Bureau) Environmental NGO 
EUREAU (European Union of National Associ ations of Water Suppliers) Water utilities 
EURELECTRIC (The Union of the Electricity Industry) Energy  
WWF (World Wild Fund) Environmental NGO 
CEFIC (European Chemical Industry Council) Chemical 
EUROMETAUX Metals 
EUROFER Metals 
EUROMINES Mining 
The list is also available on the Re gister of Commission Expert Groups51. 
List of stakeholders addresse d in the targeted consultation  
                                                 
51  http://ec.europa.eu/transparency/reg expert/detailGroup.cfm?groupID=371 , under "Sub-groups", 
"Priority Substances".  
 
EN 121   EN Organisation Sector 
FEAP (Federation of European Aquaculture Producers)* Aquaculture 
EMPA/AEPM (European Mollusc Produ cers Association)*  Aquaculture 
Europêche* Fisheries 
European Anglers' Alliance Angling 
ETF (European Transport Workers' Federation) Transport 
EAPO (European Association of Fish Producer Organisations) Fisheries 
CESA (Community of European Shipyards Associations) Shipping 
COCERAL Grain producers 
EGA (European Generic Medicine s Association) Pharmaceuticals 
CPME  (Standing Committee of Eu ropean Doctors) Public Health 
PGEU (Pharmaceutical Group of the European Union) Public Health 
European Patients' Forum Public Health 
EPHA  (European Public Health Alliance) Public Health 
HAI Europe (Stichting Health Action International Europe) Public Health 
HEAL (Health & Environment Alliance) Public Health 
BEUC (The European Consumers' Organisation) Consumers 
* These three organisations are represented on the Strategic Coordination Group under which WG E operates, 
but do not have members in WG E itself; they were targeted because of the particular relevance to them of the 
substances under review.  
 
 
 
EN 122   EN ANNEX VIII: References  
 
Abegglen C, Rosenstiel R, Ort C, Schärer M.  Weitergehende Verfaren zur Elimination von 
organischen Spurenstoffen bei kommunale n Abwasserreinigungsanlagen. Varianten und 
Kosten. Korrespondenz Abwasser, Abfall  2009, 56:6, 584-592. 
ADAS UK Ltd 2010. Impact of cha nging pesticide availability on horticulture. Report for 
Defra. http://randd.defra.gov.uk/Docume nt.aspx?Document=IF01100_10191_FRP.pdf 
AMAP 2009: Persistent Organi c Pollutants in the Arctic. Science of the Total Environment 
Special Issue . 408:2851-3051. Elsevier, 2010 
Apoteket, 2006. Environment and pharmaceuticals.  Published by Apoteket AB (The National 
Corporation of Swedish Pharmacies), Stoc kholm County Council and Stockholm University.  
Burridge LE, Haya K, Waddy SL, Wade J, 2000. Th e lethality of anti-sea lice formulations 
Salmosan® (Azamethiphos) and Excis® (Cypermet hrin) to stage IV and adult lobsters 
(Homarus americanus) during repeated s hort-term exposures. Aquaculture 182, 27-35. 
Cardinale BJ. Biodiversity improves wa ter quality through niche partitioning. Nature  2011, 
472, 86-89.  
CGEDD, 2010. Conseil Général de l’Envi ronnement et du Développement durable. 
Médicament et environnement. La régula tion du médicament vis-à-vis du risque 
environnemental. Paris, November 2010. 
Chang H, Wan Y, Wu S, Fan Z, Hu J. Oc currence of androgens and progestogens in 
wastewater treatment plants and receivi ng river waters: Comparison to estrogens. Water 
Research  2011, 45, 732-740. 
Costa LG, Giordano G. Is decabromodiphenyl ether (BDE-209) a developmental 
neurotoxicant? Neurotoxicology  2011, 32, 9-24. 
Ecolas, 2005. Assessing economic impacts of th e specific control m easures for priority 
substances and priority hazardous substanc es regulated under arti cle 16 of the Water 
Framework Directive. European  Commission DG ENV. July 2005. 
http://circa.europa.eu/Public /irc/env/wfd/library?l=/framework_directive/thematic_documents
/priority_substances/supporting_bac kground/ecolas_reportpdf/_EN_1.0_&a=d  
Entec, 2011. Substance impact reports. Prep ared to support this impact assessment. 
http://circa.europa.eu/Public /irc/env/wfd/library?l=/framework_directive/thematic_documents
/priority_substances/supporting_substances 
Entec, 2011b. Methodology report. Prepared to support this impact assessment. 
http://circa.europa.eu/Public /irc/env/wfd/library?l=/framew ork_directive/thematic_documents
/priority_substances/supporting_substances 
European Commission, 2006. Impact assesssment of the Thematic Strategy on Sustainable 
Use of Pesticides. SEC(2006)894. 
 
EN 123   EN European Commission, 2009. White paper - Adapti ng to climate change: towards a European 
framework for action. COM(2009)147 final.  
European Commission, 2009b. Common Implementa tion Strategy for the Water Framework 
Directive. Guidance Document on Exempti ons to the Environmental Objectives. 
http://circa.europa.eu/Public /irc/env/wfd/library?l=/framework_directive/guidance_document
s/documentn20_mars09pdf/_EN_1.0_&a=d  
European Commission, 2011. Commission Staff Wo rking Paper SEC(2011)1544. 
http://circa.europa.eu/Public /irc/env/wfd/library?l=/framework_directive/thematic_documents
/priority_substances/supporting_substances  
European Commission, 2011b. Common Implementa tion Strategy for the Water Framework 
Directive. Technical Guidance Document for deriving Environmental Quality Standards. http://circa.europa.eu/Public /irc/env/wfd/library?l=/framework_directive/guidance_document
s/tgd-eqs_cis-wfd/_EN_1.0_&a=d  
European Environment Agency (EEA), 2010. Pharmaceuticals in the environment. EEA 
Technical Report No. 1/2010.  
Eurostat, 2011. Database env_watq2_1 Annual wa ter abstraction by source and by sector. 
http://appsso.eurostat. ec.europa.eu/nui/show.do?d ataset=env_watq2_1&lang=en  
Herbstman JB, Sjödin A, Kurzon M, Lederman SA, Jones RS, Rauh V, Needham LL, Tang 
D, Niedzwiecki M, Wang RY, Perera F. Prenat al Exposure to PBDEs and Neurodevelopment. 
Environmental Health Perspectives  2010, 118:5, 712-9. 
HGCA 2009. Pesticide availability for cereals and oilseeds following re vision of Directive 
91/414/EEC; effects of losses and new research priorities. 
Inotai A,  Hankó B , Mészáros A , 2010  Trends in the non-stero idal anti-inflammatory drug 
market in six Central-Eastern European countries based on retail information. 
Pharmacoepidemiol Drug Saf. 19(2) 183-90.  http://www.ncbi.nlm.nih.gov/pubmed/20014174  
JRC, 2011. Estimation of the value of natural nitrogen removal in rivers and lakes. In 
preparation. 
Kidd KA, Blanchfield PJ, Mills KH, Palace  VP, Evans RE, Lazorchak JM, Flick RW. 
Collapse of a fish population afte r exposure to a synthetic estrogen. Proceedings of the 
National Academy of Sciences  2007, 104:21, 8897-8901. 
Knappe, 2008. Kampa E, Vidaurre R. Deliverable  3.3. Identification of options for the design 
of future instruments to limit pollution from pharmaceutical products into water.  
Lepper P, 2005. Manual on the Methodological Fram ework to Derive Environmental Quality 
Standards for Priority Substances in accord ance with Article 16 of the Water Framework 
Directive (2000/60/EC).  
Roig B, 2010. Pharmaceuticals in the Envir onment: Current knowledge and need assessment 
to reduce presence and impact. Edited by Benoit Roig. ISBN: 9781843393146. Published by 
IWA Publishing, London, UK. 
 
EN 124   EN SCHER (Scientific Committee on Health and E nvironmental Risks), Opinion on Chemicals 
and the Water Framework Directive: Technica l Guidance for Deriving Environmental Quality 
Standards, October 2010. http://ec.europa.eu/health/scientific_com mittees/environmental_risks/docs/scher_o_127.pdf
 
SCTEE (Scientific Committee on Toxicity, Ecotoxi city and the Environment), Opinion on the 
Setting of Environmental Quality Standards for the Priority Substances included in Annex X 
of Directive 2000/60/EC in Accordance with Article 16 thereof. Adopted during the 43rd 
plenary meeting of 28 May 2004. http://ec.europa.eu/health/archive/ph_ risk/committees/sct/documents/out230_en.pdf
 
SedNet, 2004. European Sediment Research Netw ork. Contaminated Sediments in European 
River Basins. http://www.sednet.org   
SRU, 2007. German Advisory Council on the E nvironment. Statement Nb. 12, April 2007. 
Pharmaceuticals in the Environment. http://www.umweltrat.de/SharedDocs/Downl oads/EN/04_Statements/2007_Statement_12_Ph
armaceuticals_Environment .pdf?__blob=publicationFile 
Sundseth K, Pacyna JM, Pacyna EG, Munthe J, Belhaj M, Astrom S. Economic benefits from 
decreased mercury emissions: Projections for 2020. Journal of Cleaner Production  2010, 18, 
386-394. 
Swedish Medical Products Agency, 2009. Sustai nable Development and Pharmaceuticals. 
Post Conference Booklet. 10-11 November.