COMMISSION STAFF WORKING PAPER IMPACT ASSESSMENT
Date: 2012-01-31
Institutions: European Commission
Subjects: dangerous substance, environmental impact, environmental monitoring, water analysis, water pollutant, water treatment

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} 

 
 
 
 
 
 
 
 
 
Disclaimer: This impact assessment commits only the Commission's services involved in its 
preparation  and  does  not  prejudge  the  final  form  of  any  decision  to  be  taken  by  the 
Commission.

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TABLE OF CONTENTS 

1. 

1.1. 

1.2. 

1.3. 

1.4. 

Procedural issues and consultation of interested parties .............................................. 6 

Overview ...................................................................................................................... 6 

Impact Assessment Steering Group (IASG) ................................................................ 6 

Expertise for the technical process............................................................................... 6 

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 persistent, bioaccumulative and toxic (PBT) 

chemicals.................................................................................................................... 15 

2.2.5.  Knowledge base ......................................................................................................... 16 

2.3.  What are the underlying drivers 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 persistent, bioaccumulative and toxic chemicals23 

2.5.3.  Knowledge base ......................................................................................................... 23 

2.6. 

Does the EU have the right to act?............................................................................. 24 

3. 

4. 

4.1. 

4.2. 

Objectives................................................................................................................... 24 

Policy options............................................................................................................. 25 

Overview .................................................................................................................... 25 

Policy options in relation to the substances ............................................................... 25 

4.2.1. 

Introduction................................................................................................................ 25 

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4.2.2.  The options A1, A2 and A3 (a)-(c) ............................................................................ 26 

4.3. 

Policy options in relation to the specific difficulties with ubiquitous PBTs.............. 27 

4.3.1.  Option B1: No change................................................................................................ 28 

4.3.2.  Option B2a presentation: Allow separate presentation of ubiquitous PBTs.............. 28 

4.3.3.  Option B2b presentation: Take ubiquitous PBTs out of chemical status .................. 28 

4.3.4.  Option B3a choice of matrix: Leave flexibility but link the choice to requirements of 
Directive 2009/90/EC ................................................................................................ 28 

4.3.5.  Option B3b choice of matrix: Fix the preferred matrix for each substance............... 29 

4.3.6.  Option B4a monitoring: Introduce reduced monitoring obligations for ubiquitous 

PBTs if certain specified conditions are met.............................................................. 29 

4.3.7.  Option B4b monitoring: Introduce reduced monitoring obligations 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 list without legal obligation........................................ 30 

4.4.4.  Option C3: Establish a watch list with legal obligation............................................. 30 

5. 

5.1. 

5.2. 

Analysis of impacts and comparison of the options................................................... 30 

Introduction ................................................................................................................ 30 

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: Existing-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. 

5.4. 

Comparison of the substance options......................................................................... 50 

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 

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5.4.2.  Analysis of impacts of Option B2b on presentation: Take ubiquitous PBTs out of 

chemical status ........................................................................................................... 52 

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....................................................... 53 

5.4.4.  Analysis of impacts of Option B3b on choice 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 certain 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. 

5.6. 

Comparison of options in relation to the ubiquitous PBTs ........................................ 55 

Analysis of impacts of options to improve the knowledge base................................ 56 

5.6.1.  Analysis of impacts of Option C2: Establish a watch list without legal obligation... 56 

5.6.2.  Analysis of impacts of Option C3: Establish a watch list with legal obligation........ 56 

5.7. 

5.8. 

Comparison of the options to improve the knowledge base ...................................... 57 

Cumulative impacts, interactions across the various options and significant 
distributional effects................................................................................................... 57 

5.8.1. 

Interactions and cumulative impacts.......................................................................... 57 

5.8.2.  Cumulative impacts of the package of preferred options........................................... 59 

5.8.3.  Distributional effects of the package of preferred options......................................... 60 

5.8.4.  Approach to translating the options 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 ubiquitous 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 affecting the baseline and interactions with the 
WFD 

ANNEX VII: List of stakeholders involved in the consultation  

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ANNEX VIII: References 

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1. 

PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES 

1.1. 

Overview 

The  Commission  proposal  which  this  Impact  Assessment  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/EC1 (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  list  through  a  prioritisation  exercise,  to  set 
environmental quality standards (EQS)2 for them, and to review the 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  Entec3.    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,  possible  improvements  in  the  functioning  of  the 
Environmental  Quality  Standards  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 sets of options. The preferred option 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 held 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  groups  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. principally the prioritisation and EQS setting, was led 
by DG ENV and the JRC and carried out by a range of experts.  These included members of 

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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 
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) 
Study Contract No 070307/2009/547548/SER/D1 
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). 
Directive  2008/105/EC  of  the  European  Parliament  and  of  the  Council  of  16  December  2008  on 
environmental  quality  standards  in  the  field  of  water  Policy  [OJ  L  348,  24.12.2008,  p.  84]  http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32008L0105:EN:NOT 

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the Chemical Aspects Working Group E under the WFD Common Implementation Strategy 
(CIS)6, in particular two sub-groups of WG E, and 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  organisations  including  a  range  of 
(AESGP,  AISE,  Business  Europe,  CEFIC,  CEPI, 
European 
CONCAWE,  COPA-COGECA,  ECPA,  EFPIA,  EUCETSA,  EUDA,  EUREAU, 
EURELECTRIC,  EUROFER,  EUROMETAUX,  EUROMINES)  and  NGOs 
(EEB, 
Greenpeace, OSPAR , WWF).  Annex VII gives the full names and sectors. 

industry  associations 

WG E contributed significantly to the review by supporting the collection of data (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  JRC.    The  WG  E  industry  stakeholder  groups 
involved their most relevant member companies, generally represented by technical experts, 
in  the  sub-group  discussions,  particularly  as  the  selection  procedure  reached  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 most relevant stakeholder organisations - were 
kept informed of the progress on the technical work in the sub-groups throughout the review 
process.  They  contributed  information  to  that  process  and  provided  information  to  the 
consultancy  Entec  for  the  impact  assessment  study.    They  were  consulted  twice  on  the 
methodology and twice on the draft substance impacts reports. 

The penultimate drafts of the substance impacts reports were also sent to additional selected 
stakeholders in a targeted stakeholder consultation, 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, their involvement throughout the process, and the technical nature 
of the review, it was judged appropriate to target additional consultation to selected additional 
organisations  rather  than  to  conduct  a  full  public  consultation.  Other  DGs  were  asked  to 
propose  organisations  whose  interests  might  require  additional  representation,  and  those 
targeted  included  groups  representing  the  fishing/aquaculture  and  transportation  industries, 
medical professionals and users/consumers. Output from a public internet consultation would 
likely have been of a very general nature, and unlikely 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 

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http://ec.europa.eu/environment/water/water-framework/objectives/pdf/strategy.pdf  
The SCHER is one of the Scientific Committees providing the Commission with independent advice. It 
is 
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http://ec.europa.eu/health/scientific_committees/environmental_risks/index_en.htm   

information 

scientists. 

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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  highlighting  substances  of  concern  or  relevant  toxicity  studies.  The 
general view of MS and stakeholders 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  informed  by  discussion  on  issues  including  the 
appropriateness of setting sediment and biota standards, 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 effectively with other legislation (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  comments.  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  clearly  presented  (see  point  2 
below); the introductory parts of section 5.2 explain in more detail the analysis of costs and 
benefits  of  the  substance  options  and  the  uncertainties  involved;  and  specific  reference  is 
made to SMEs. Finally, the preferred policy package is compared to the baseline in section 
5.8.2. 

The Board provided five main groups of recommendations.  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 candidate 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  references  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 

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The section on the baseline (2.5.1) has been expanded 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 options 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 national standards for the candidate PS are now 
given in the table in section 2.2.3 (the details can still be found in Annex VI) and comment is 
made  on  the  likelihood  that  other  MS  would  follow.  The  information  on  exemptions  in 
section 2.1 distinguishes between applications on the basis of disproportionate 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 and text on the individual substance options 
in section 5.2). The issue of disproportionate costs, including the relevance 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 contribution made by the WFD 
to providing monitoring data in sections 2.5.1 and 5.2, by summarising the risks posed by the 
candidate  substances  in  section  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 for SMEs are indicated in section 5.2.1.2 and the 
sections in 5.2 analysing the individual substance options (especially the adapted tables). The 
compliance strategies of MS are mentioned in section 5.3, and reference to the likelihood of 
MS exempting SMEs on grounds of disproportionate costs is made in section 5.2.1.2. 

(5) Include a clear overview of costs and benefits of the retained 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  baseline  has  been  made  more  consistent.  The 
benefits and costs of the preferred package of options are summarised in section 5.8.2, and the 
section on distributional impacts elaborates on several points, including the possible impact of 
high production and use coinciding in particular MS. 

Additional technical comments by the Board have 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 Summary has been complemented with a summary 
of the costs and benefits of the preferred package of options. 

2. 

PROBLEM DEFINITION 

2.1. 

Introduction: policy context/background 

The WFD acknowledges the existence of considerable pressures on the aquatic environment, 
including that from chemical pollution, and the need for sustainable water management.  Its  

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environmental objectives include the achievement of good chemical and ecological status for 
surface  and  groundwater  bodies,  and  the  prevention  of  deterioration.    The  Directive  is 
implemented at the level of river basin districts (RBDs).  MS were required 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 programme 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, pesticides and metals/metal compounds. Some PS 
are  identified  as  Priority  Hazardous  Substances  (PHS)  because  of  their  persistence, 
bioaccumulation  and/or  toxicity  or  equivalent  level  of  concern,  criteria  consistent  with  the 
criteria  for  Substances  of  Very  High  Concern  (SVHCs)  under  REACH.  MS  are  required  to 
monitor the PS in surface water bodies, and to report exceedances of the EQS.  The objective 
of  good  ecological  status  requires  that  for  chemicals  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  known  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  Parliament  in  2011.    As  part  of  the  review,  the  Commission  has  to 
consider  inter  alia  the  substances  in  Annex  III of  the  Directive  for  possible  inclusion  in  the 
list.  It is also required to identify, if appropriate, new PS or PHS, and to set EQS for surface 
water,  sediment  or  biota9  as  appropriate,  and  to  review  the  existing  PS.    The  proposed  new 
substances  and  changes  to  existing  substances  are  expected  to  be  taken  into  account  in  the 
2015 updated RBMPs and programmes of measures. 

Member States' first RBMPs, and their progress on complying with the EQS for the existing 
PS, are currently being assessed.  However, because 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  preliminary  assessment  shows  that  significant 
percentages  of  water  bodies  are  currently  failing  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  chemical  status  objective  on  socio-economic 
grounds, either to allow extension of the deadlines (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 natural conditions not allowing timely improvement – 
in that order, i.e. technical unfeasibility is cited more than twice as often as disproportionate 
costs,  which  is  cited  in  turn  more  than  twice  as  frequently  as  natural  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. 

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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. 

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Despite  the  current  failures  -  largely  for  substances  that  persist  in  the  environment  and/or 
undergo  long-range  transport  -  there  is  evidence  that  the  concentrations  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.  Listing in itself appears to have contributed to 
increased awareness of the need to take control 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 increase 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 thousands of chemicals are used daily in the EU for 
multiple  purposes11.  Some  are  active  at  very  low  concentrations  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  their  lifecycle,  from  production  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 consumption 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  been  linked  in  epidemiological  studies  with 
neurodevelopmental  effects  in  infants;  and  neurodevelopmental  effects,  altered  habituation 
patterns,  hyperactivity,  learning  and  memory  deficits  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 already on the PS list  or  proposed for 
addition  are  ubiquitous  persistent,  bioaccumulative  and  toxic  (PBT)  substances  and,  despite 
being  already  heavily  regulated,  will  produce  widespread  failures  of  the  objective  of  good 
chemical status for many years due to their intrinsic 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  fit-for-purpose  monitoring  data  on  which  to  base 
assessment of exposure12 and thus the prioritisation of new PS in future reviews.   

10  

11  
12  

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] 
http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Chemicals_management_statistics 
In  the  context  of  risk  assessment  “exposure”  refers  to  the  amount  of  contaminant  (dose)  that  an 
individual or the population will receive. This is compared with the predicted no-effect concentration to 
perform the risk assessment.  

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2.2.3.  New information on risks to environment and human health 

A  range  of  new  information  was  reviewed,  including  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  number  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 matrix13. 

The  selection  of  possible  new  PS  was  conducted  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  product  (PPP)  and  biocides  legislation),  and  the 
assessment of intrinsic hazard and exposure according 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 the EQSs derived) is provided in Annexes II and 
V.  Although  several  other  substances  were  acknowledged  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.  Cypermethrin,  Dichlorvos)  are  characterised  by  their  acute  toxicity. 
For  some  toxic  substances,  chronic  effects  may  be  more  important  than  acute  effects, 
depending  upon  how  the  concentrations  of  the  substance  in  water  vary,  and  upon  the 
organisms  affected.    Some  of  the  substances  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 information on the 15 possible new PS: 

Substance 
17 alpha-
ethinylestradiol 
(EE2) 

17 beta-
estradiol (E2) 

Aclonifen 

Concern 
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)   

Type/Use  
Pharmaceutical; synthetic 
steroid hormone used 
mainly in oral 
contraceptives.  No 
production data available. 
Approx 32 million women 
in EU use EE2-based 
contraception. 
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). 
Herbicide, used on a range  Toxic to a range of aquatic 

Endocrine disruptive; chronic studies 
show  effects  on  sexual  development 
and fecundity in fish. 

State of play in MS 
Monitoring database 
contains data from 3 
countries, 2 showing 
exceedance of EQS, 1 
likely exceedance; 
literature predicts 
exceedances more 
widely. 
Monitoring database (2 
countries) and 
literature show 
exceedance of EQS. 

National standard 

13  

Matrix refers to water, sediment or biota, the three compartments of the aquatic environment in which 
contaminants can be measured.  

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exists in SE. 
3 countries in 
monitoring database, 
FR data predominant 
and showing 
exceedance. 
Authorised in 18 MS. 
3 countries in 
monitoring database; 
FR data predominant 
and showing 
exceedance. 
Authorised in 19 MS. 
National standard 
exists in SE. 
4 countries in 
monitoring database; 
exceedance or near 
exceedance of EQS in 
3. 
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. 

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. 

of arable crops. 
Use > 1000 tonnes/yr. 

organisms. 

Bifenox 

Herbicide, used to kill 
broadleaf weeds in cereal 
crops and grassland. 
Use > 200 tonnes/yr. 

Toxic to a range of aquatic 
organisms. 

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. 

Toxic to a range of aquatic 
organisms. Benthic invertebrates 
vulnerable because cypermethrin 
binds to sediment14. Use in the 
marine environment is authorised in 
a few countries of the world but 
prohibited in Canada15 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). 
Toxic particularly to aquatic 
invertebrates and fish; possibly 
carcinogenic to humans. (No longer 
authorised as PPP.) 

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. 

Dichlorvos 

Diclofenac 

Dicofol 

Dioxins (and 

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.  
Pharmaceutical, used as 
NSAID. 
Average consumption 0.46 
g/person/yr. 

Organochlorine PPP, until 
recently authorised for use 
on fruit and vegetable 
crops. 
Possibly residual use. 
Dioxins: by-products of 

Monitoring and 
predictions show 
exceedances of the 
EQS in water in 7 MS 

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. 
Toxic; similar to DDT, 
recommended for designation as 
POP (Stockholm Convention); 
possibly carcinogenic to humans, 
possibly endocrine disruptive. 
PBTs, POPs (Stockholm Convention  National standards 

Monitoring database 
shows failure of EQS 
in ES and FR, likely 
elsewhere. 

14  
15  
16  

http://www.scotland.gov.uk/Publications/2002/08/15170/9409  
http://www.worldwildlife.org/what/globalmarkets/aquaculture/WWFBinaryitem8842.pdf  
http://www.cbc.ca/news/canada/new-brunswick/story/2010/02/18/nb-aquaculture-pesticide-bay-of-
fundy-lobster-deaths-658.html  
http://quoddytides.com/salmon10-8-10.html,  

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dioxin-like 
PCBs)  

HBCDD 

thermal combustion 
PCBs: chlorinated organic 
compounds formerly used 
to manufacture electrical 
equipment etc.; some also 
produced by combustion. 

Industrial chemical, used 
as flame retardant, 
especially in polystyrene, 
including insulation 
boards. 
Use up to 10000 tonnes/yr. 

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. 
PBT, SVHC under REACH, 
recommended POP. Possibly toxic to 
reproduction in humans. 

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.. 

PFOS 

Quinoxyfen 

Terbutryn 

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. 
Fungicide, used mainly on 
cereals, grape vines. 
Use approx 70 tonnes/yr. 

Biocide, used especially in 
coatings for buildings, as 
preservative. 
Use approx 200 tonnes/yr. 

PBT, POP. Toxic to animals 
especially mammals. Possible 
carcinogen in humans; possible 
effects on thyroid function.. 

PBT and vPvB properties. 
Accumulates particularly in 
sediments. 

Toxic especially to algae and aquatic 
plants.. 

exist in 3 MS (DK, IT, 
SE). IE simply 
monitors. 
Several MS report 
likely exceedance of 
EQS. 

National standards 
exist in 2 MS (DK, 
SE). 
Monitoring data 
mainly from literature 
show exceedances of 
EQS. 
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 
National standards 
exist in 3 MS (CZ, DK, 
SE). 
4 countries in 
monitoring database, 
all showing 
exceedance of EQS 

Monitoring data from 2 
MS; some exceedances 
of EQS in FR. 
Authorised in 17 MS. 
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,  Naphthalene,  Nickel,  PAHs,  Fluoranthene  and  Trifluralin)  are 
explained  in  Annex  II.    In  most  cases,  a  (revised)  EU  Risk  Assessment  Report  (RAR)  had 
become available since the existing EQS was established. 

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2.2.4. 

Specific  difficulties  with  ubiquitous  persistent,  bioaccumulative  and  toxic  (PBT) 
chemicals 

2.2.4.1.  Introduction 

By  definition,  PBTs  persist  in  the  environment,  bioaccumulate  in  the  trophic  chain  and  are 
toxic.  They  are  classified  in  the  WFD  as  Priority  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 compounds in the Arctic – see AMAP 2009). 

The  measures  already  taken  regarding  several  existing  PBTs  have  reduced  emissions 
significantly.  In addition, the REACH Regulation is now providing a mechanism to identify 
PBTs  as  substances  of  very  high  concern  (SVHC)  and,  where  they  are  included  in  Annex 
XIV, they become subject to authorisation, which ensures their progressive substitution on the 
market  with  less  hazardous  substances,  where  this  is  economically  and  technically  feasible. 
However, their existing concentrations, particularly in sediment and/or biota, could still pose a 
risk  to  the  aquatic  environment  and/or  to  human  health  via  the  aquatic  environment,  and 
natural recovery will generally take decades. 

Because  of  their  properties,  regulation  of  these  substances  under  the  WFD  poses  particular 
problems. Three issues or sub-problems 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 their 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  situation  for  some  chemicals  can  therefore  hide 
positive situations for  other  substances. The maps  may  then  be  dominated  by  failures  about 
which little more, if anything, can be done from 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 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 
and 
substances 
Hexachlorobutadiene),  EQS  for  biota  are  given  in  the  EQSD17  that  MS  have  to  use  unless 
they develop and apply a water standard that offers the same level of protection as the biota 

(Mercury,  Hexachlorobenzene 

for  water.  For 

three 

17  

These  substances  are  hydrophobic  and  bioaccumulative  and  therefore  the  preferred  matrix  for 
monitoring is biota; their concentrations in water are so low that are rarely measurable 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. 

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standard. Most of the ubiquitous PBTs (and some other substances) are very hydrophobic. It 
is therefore difficult to monitor them in water. The analytical techniques 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 determination. This means that where the results 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  analytical 
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  minimum  criteria,  the  best 
available  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 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 contain elevated values in sediment and/or biota that pose a risk 
to  or  via  the  aquatic  environment,  and  unacceptable  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  EQS  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 may 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  cycle.  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 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  monitoring  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. environmental concentrations, preferably measured but otherwise 

reliably modelled on the basis of production volumes, use patterns and/or emissions. 

Although a vast amount of monitoring data was gathered for the current review of the PS list, 
constituting a very significant improvement in relation to the last prioritisation exercise, and 

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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 substances, including the unevenness of data collection across the 
EU. This prevented the proper assessment of the risk posed by some 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, estimation of the risk posed 
to and via the aquatic environment at EU level may not be robust enough to justify regulation.  
Since the listing of a substance implies an obligation 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  above  the  no-effect  level.    Despite  monitoring, 
uncertainty may therefore remain regarding whether 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)  are  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 picture; 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 

o 

lack of a clear mechanism for collecting information at EU level, i.e. although Article 
3  of  Decision  2455/2001/EC  specifies  that  "MS  shall  ensure  that  the  substance  and 
exposure-related data needed for the implementation of the COMMPS procedure are 
made available", some MS provide a lot of data and some very little; 
lack of EU representativeness of monitoring 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 fewer; only for 30 substances do data come 
from more than 18 countries; 

o  need  for  more  consistent  implementation  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  pollutants,  monitoring  data  are  sparse,  even 
though evidence exists that among them there are a number that may pose a risk; 
o  quality of the monitoring data, i.e. the need for analytical techniques 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 

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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 significant source of emissions is the disposal of 
unused pharmaceuticals. Although EU legislation obliges MS to establish take-back schemes, 
it  does  not  impose  reporting  obligations  or  efficiency  targets.  There  are  therefore  no 
comprehensive  data  on  the  functioning  of  the  schemes,  despite  a  recent  survey  by  the 
European Federation of Pharmaceutical Industries and Associations (EFPIA). What is clear, 
though, is that a significant quantity of unused drugs 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  amount  of  pharmaceuticals  collected  in  various 
European countries varies significantly, generally in the range of 10 to 100 tonnes per million 
inhabitants per annum. The rate is very high in Switzerland followed by Ireland, Luxembourg, 
Sweden and France (EEA 2010).   

Improper  disposal  could  be  a  significant  source  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 expiry). 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  waste  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 menstrual 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 arises 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 environment, 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  that  conventional  urban 
waste water treatment is not capable of adequately removing all the pollutants, and installing 
tertiary treatment on a widespread basis would be expensive. 

In  relation  to  the  problems  described  for  ubiquitous  PBTs,  it  is  clear  that  historic  pollution 
accounts for much of the contamination that exists and therefore for the difficulties faced by 
MS  in  achieving  good  chemical  status.  The  relatively  uniform  (with  respect  to  type  of  PS) 
requirements of the WFD and EQSD appear 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 Directive 2009/90/EC on technical specifications for 
chemical analysis do not provide enough guidance to limit the choice.  

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Finally,  the  paucity  of  high-quality  and  fit-for-purpose  monitoring  data  to  support  the 
prioritisation  exercise  appears  to  result  principally  from  the  absence  of  a  clear,  targeted 
mechanism to gather such data. 

2.4.  Who is affected by the problems identified, 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 same time, it is indeed a key economic resource. The 
increasing economic development of Europe has not only increased the 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, agricultural and aquacultural purposes.   They also 
serve  as  receptors  for  waste  including  industrial  and  domestic  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 through the aquatic environment, for example via 
the  consumption  of  drinking  water,  fish  or  shellfish.  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 ecology are key for biodiversity. Around 
70%  of  the  protected  habitats  and  species  in  EU  legislation  are  water  related.  Chemical 
pollution can reduce the richness of the aquatic ecosystem and, consequently, its functionality, 
hence decreasing its resilience, its capacity to handle pollution (Cardinale 2011).  At the same 
time, the amenity value of water bodies as features of the landscape that support recreational 
activities such as angling, swimming and boating is reduced. 

The potential effects of the 15 possible new PS are outlined in section 2.2.3 (see also Annexes 
II  and  V  for  details).  Because  those  effects,  and  likewise  the  effects  of  the  existing  PS,  are 
relevant  to  society  as  a  whole,  they  are  obviously  also  directly  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 implementing 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 expected, 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 significant uncertainty for 
several reasons. The most important is that several pieces of legislation are already in place 

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19 

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that  will  or  may  have  an  impact  on  the  use  and  emissions  of  some  of  the  substances  in  the 
coming  years,  and  therefore  on  their  concentrations  in  the  aquatic  environment.    The  most 
important of these are the WFD Programmes of Measures, the PPP legislation including the 
Directive on the sustainable use of  pesticides,  .the REACH Regulation, industrial emissions 
policy, and the legislation on biocides, pharmaceuticals, waste and POPs. Some information 
on which substances are subject to the legislation, and on the implications, is provided here; 
further details are in the tables in section 5.2 and in Annexes V and VI.  

Decisions under the other legislation are likely to lead to decreased emissions to water or no 
change.  In  some  cases,  decisions  are  awaited  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  from  Annex  I  to  the  Biocidal  Products  Directive  in  the  current 
review  would  mean  no  change.    Further,  even  where  a  decision  is  made  to  restrict  use,  the 
measure might have greater or lesser effect depending 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 

WFD 
Programmes of 
Measures in MS 

Developments/general implications 

Relevant substances/specific implications 

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. 

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. 

Biocidal Products 
Directive 
98/8/EC 

REACH 
Regulation 

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. 
Registration process ongoing; may bring 
new information and potential action, 

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. 
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.) 
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. 
Existing PS: Anthracene, DEHP, Fluoranthene, 
Lead, Naphthalene, Nickel, PAHs; 

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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. 

POPs legislation: 
Stockholm 
Convention19, 
POPs Protocol to 
UNECE 
CLRTAP20, 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. 

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  

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. 
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.) 
Potentially all substances but particularly 
industrial chemicals discharged 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  
20  
21  

http://chm.pops.int/Convention/ThePOPs/tabid/673/language/en-GB/Default.aspx;  
http://www.unece.org/env/lrtap/pops_h1.htm  
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:229:0005:0022:EN:PDF  

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21 

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Waste legislation 
– several acts and 
decisions 

Pharmaceutical 
legislation 

Other legislation 

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. 

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. 
Rotterdam Convention: a substance 
listed in Annex III becomes subject to 
the Prior Informed Consent (PIC) 
procedure23. 

approach to BAT not effective until 2014.. 
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 waste22. 
Diclofenac, E2, EE2. – uncertainty regarding 
MS action on take-back schemes and outcome 
of Commission study. 

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 although 10 of the 15 proposed PS are designated as RBSPs, this only applies in 
a few MS. This suggests that only a few MS would act on those substances in the absence of a 
proposal to list them as PS24, although it is not possible to predict which substances the MS 
will  identify  as  RBSPs  in  their  updated  RBMPs  in  2015.    Less  action  could  mean  more 
frequent exceedance of no-effect levels. In the few MS where 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  measures  are  taken  to  reduce  concentrations 
below their current levels and on the level of the quality standard set by the MS.  As has been 
found for other RBSPs, considerable variation between MS is observed, both in terms of the 
magnitude  of  the  standard  and  the  chosen  matrix  (see  Table  in  Annex  VI),  meaning  that 
without  the  harmonised  EQS  derived  for  each  substance  as  a  PS,  different  baselines  would 
likely be seen in the different MS. Some of the standards are significantly less stringent than 
being proposed here. 

In the absence of a proposal to list the possible new PS in the EQSD, the baseline scenario 
would  include  almost  no  monitoring  of  those  substances  in  the  aquatic  environment.    Most 
would  only  be  monitored  in  the  few  MS  where  they  are  listed  as  RBSPs.    Under  the 
Stockholm  Convention  there  are  some  non-binding  recommendations  for  the  monitoring  of 
POPs;  and  Regulation  (EC)  No  850/2004  Article  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  environment,  though  no  specifications  are  given.  The 
limited extent of baseline monitoring of the proposed PS would 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  
23  
24  

http://ec.europa.eu/environment/waste/studies/pdf/POP_Waste_2011.pdf  
http://www.pic.int/Procedures/PICProcedure/tabid/1364/language/en-US/Default.aspx  
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 there 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.  

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22 

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decisions  taken  under  the  other  relevant  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  stringent,  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 have to be revised.  If  the status  of  DEHP 
were not changed, too little attention might be paid 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 aquatic 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 approved 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 persistent, bioaccumulative and toxic chemicals 

This  issue  relates  to  the  functioning  of  the  EQSD  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  substances  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 would likely show a worse picture 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 provide 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 would be more suitable.  There would continue to 
be many false "good chemical status" reports, harmonisation would not be achieved, and there 
would be less scope for identifying and possibly remediating highly contaminated sites. 

As  regards  the  monitoring  effort,  departure  from  the  minimum  requirements  in  the  WFD 
requires technical justification that some MS may not be in a position to elaborate.  MS would 
continue  to  monitor  on  the  basis  of  the  minimum  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  monitoring  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. 

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23 

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For future exercises, the implementation of REACH and the PPP Regulation of 2009 hold the 
promise  of  providing  some  assistance,  although  neither  is  likely  to  lead  to  the  provision  of 
targeted, EU-wide monitoring data relating 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  refers 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 although it could go into an EU database, it might 
still not be fit for purpose for the reasons explained in section 2.2.5. 

2.6. 

Does the EU have the right to act? 

Water pollution has a very important transboundary character. 60% of the EU territory lies in 
shared  river  basins  (EC,  2007).  Because  of  this,  and  because  many  substances  that  cause 
pollution are used across the EU anyway, it is appropriate to set harmonised EQS for them at 
EU level where a significant risk to or via the aquatic environment is identified. Apart from 
the wider protection, a more level 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 provide for the list of PS to be reviewed every 
four  years  and  the  EQS  within  two  years  after  the  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 substances and the EQS. As regards the problems of ubiquitous PBTs 
and the knowledge base, the proposals concern action aimed at improving the functioning of 
the existing legislation. 

3. 

OBJECTIVES 

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 
− 
−  Provide adequate tools to improve the future identification of substances of concern to 

Improve the functioning of the EQSD 

or via the aquatic environment at EU level. 

The specific objectives are the following: 

−  Consider the latest scientific knowledge in the review of existing PS  
− 

Identify new PS and set EQS for them 

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24 

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−  Ensure improved knowledge, through monitoring, of the risks posed by existing and 

proposed PS and the effectiveness of measures taken to reduce or eliminate emissions 
− 
Improve communication of the progress 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 maintaining 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 overarching EU objective, reinforced in the Treaty 
of Lisbon, that the EU will work for the sustainable development of Europe based, in 
particular, on a high level of protection and improvement of the quality of the environment.  

4. 

POLICY OPTIONS 

4.1. 

Overview 

The options presented in this section address 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, sub-problems and objectives: 

Problem 
New information on 
risks to environment 
and human health 

Sub-problem 
Existing substances 

General objective 
Reduce the risks to or 
via the aquatic 
environment posed by 
certain substances 

Proposed substances 

Specific difficulties 
with ubiquitous PBTs 

Presentational issues 

Improve the 
functioning of the 
EQSD 

Choice of matrix 

Monitoring effort 

Knowledge base 

- 

Provide adequate 
tools to improve the 
identification of 
substances of concern  

Specific objectives 
Consider the latest scientific 
knowledge 
Ensure improved knowledge 
through monitoring 
Identify new substances that pose 
risks and set EQS for them 
Ensure improved knowledge 
through monitoring  
Improve communication of 
progress 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 
Provide a mechanism to improve 
the knowledge base and make 
future identification of PS more 
effective 

Options 
A2 

A3a-A3c 

B2a-B2b 

B3a-B3b 

B4a-B4b 

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  refer  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-wide EQS for them.  If a substance is identified as a PS but 

EN 

25 

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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  establishes  the  obligation  for  the  Commission  to  propose 
control  measures  at  EU  level  to  achieve  the  emission  objectives  for  PS  and  PHS  (For  the 
latter,  cessation  and  phase-out  should  occur  within  20  years  of  the  adoption  of  such 
measures).  Measures  may  involve  process  controls  (including  emission  controls  for  point 
sources)  and  product  controls.  However,  several  existing  EU  policies,  for  example  for 
industrial  chemicals,  PPPs,  biocides  and  veterinary  medicines,  include  mechanisms  and 
criteria that can be used to a greater or lesser extent to develop and decide on such controls to 
address the risks identified by the WFD. It would not be appropriate for the Commission to 
propose  alternative  controls  for  specific  substances  on  the  basis  of  the  WFD.  This  would 
create unnecessary double regulation. Therefore, the options do not specify measures.  They 
assume  that  the  other  EU  policies  will  establish  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 measures that might reduce emissions to water 
of  certain  existing  or  proposed  PS,  such  as  authorisation  for  limited  uses  under  REACH  or  
withdrawal of an authorisation under the biocides or PPP legislation, or the establishment of 
additional  mitigation  measures  during  use,  are  likely  to  be  taken  under  the  baseline.  
However,  some  might  be  triggered  or  accelerated  as  a  result  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 legislation 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,  starting  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  first  option  including  newly  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  Working  Paper  SEC(2011)1544  (European  Commission 
2011). Effectively five (if Dioxins and Dioxin-like PCBs are counted 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? 

Option A2: Change 
EQS and/or status of 
existing PS 

Anthracene 
Poly-BDE 
DEHP 

Y (minor) 
Y (significant25) 
N 

N 
Y  
N 

N 
N 
Y 

25  

If change is higher than one order of magnitude. 

EN 

26 

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Option 

Substance 

Change or 
establishment of 
EQS in water?  

Biota 
EQS 
proposed? 

Change from PS 
or identified as 
PHS? 

Lead 
Naphthalene   
Nickel 
PAHs 
   Benzo(a)pyrene 
   Benzo(b)fluoranthene 
   Benzo(k)fluoranthene 
   Indeno(1,2,3-cd)pyrene 
   Benzo(g,h,i)perylene 
Fluoranthene 
Trifluralin 
Dicofol 
PFOS 
Quinoxyfen 
Dioxins and DL-PCBs 
Aclonifen 
Bifenox 
Cybutryne 
Cypermethrin 
Dichlorvos 
HBCDD 
Heptachlor/ heptachlor 
epoxide 
Terbutryn 
17 alpha-ethinylestradiol 
17 beta-estradiol  
Diclofenac 

Y (minor) 
Y (minor) 
Y (significant) 

Y (significant) 
Y (significant) 
Y (significant) 
Y (significant) 
Y (significant) 
Y (significant) 
N 
Y 
Y 
Y 
N 
Y 
Y 
Y 
Y 
Y 
Y 
Y 

Y 
Y 
Y 
Y 

N 
N 
N 

Y  

N 
Y  
N 
Y 
Y 
N 
Y 
N 
N 
N 
N 
N 
Y 
Y 

N 
N 
N 
N 

N 
N 
N 

N 

N 
Y 
Y 
Y 
Y 
Y 
N 
N 
N 
N 
N 
Y 
Y 

N 
N 
N 
N 

Option A3a: Existing-
PS changes plus Annex 
III substances 

Option A3b: Existing-
PS changes plus Annex 
III substances plus 
other new substances 
excluding 
pharmaceuticals 

Option A3c: Existing-
PS changes plus Annex 
III substances plus 
other new substances 
including 
pharmaceuticals 

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  heading,  with  their  own  objectives.  Options  have 
been structured as follows: 

Option 

Presentation 

Choice of matrix 

Monitoring effort 

B1 

B2a 

B2b 

B3a 

B3b 
B4a 

B4b 

No change (presentation of all PS 
results together) 

No change (choice is fully free) 

No change (minimum frequency but 
some flexibility if technically 
justified) 

Allow separate presentation of 
ubiquitous PBTs 
Take ubiquitous PBTs out of 
chemical status 

Conditioned to meeting or coming 
closest to the minimum performance 
criteria of Commission Directive 
2009/90/EC 
Fixed choice for each substance 

Introduce reduced monitoring 
obligations for ubiquitous PBTs if 
certain specified conditions are met 
Introduce reduced monitoring 
obligations for ubiquitous PBTs 

EN 

27 

   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 explained in section 2.5. 

4.3.2.  Option B2a presentation: Allow separate presentation of ubiquitous PBTs  

This option identifies a number of substances that are ubiquitous PBTs at EU level and allows 
MS to present the assessment for some or all of these substances separately (e.g. in separate 
maps) from that for the rest of the PS in the 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  substances,  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 assessment of the concentrations of these chemicals. No 
other legislative tool provides for their monitoring 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  criteria  of  Directive 
2009/90/EC in one matrix and not in the other(s), or  

•  no  analytical  technique  meets  the  performance  criteria  but  the  technique  for  one 

matrix performs significantly better than 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 criteria in Directive 2009/90/EC or performs 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 analytical technique performs significantly better in 
relation to the criteria in Directive 2009/90/EC. 

26  

As  explained  in  the  problem  definition  section,  options  B3a  and  B3b  are  most  obviously  relevant  to 
ubiquitous PBTs but would apply to all PS. 

EN 

28 

   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 performance of the analytical methods would be left to the MS, 
possibly with some technical guidance to be developed 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 preferred matrix for each substance 

The choice of matrix for monitoring and compliance 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. criteria for applying the flexibilities in the WFD 
and  EQSD  as  regards  monitoring  frequencies  (based  on  "technical  knowledge  and  expert 
judgement")  and  for  reducing  the  number  of  sites  at  which  the  ubiquitous  PBTs  need  to  be 
monitored.    This  reduced  monitoring  effort  could  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  prejudice  to  the  need  to  undertake  more  detailed 
monitoring if local measures had to be taken and 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 explained in section 2.5. 

4.4.2.  Options C2 and C3: Establishment of a watch list 

These options would involve establishing a watch list.  The aim would be to ensure targeted 
monitoring  across  the  EU  of  substances  of  possible  concern,  for  example,  emerging 
pollutants, to provide a database of high-quality information fit for the purpose of subsequent 
prioritisation  exercises  under  the  WFD.    Two  approaches  would  be  possible,  a  watch  list 
without  a  legal  obligation,  or  a  watch  list  with  a  legal  obligation.    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 

29 

   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 informal 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 ensuring political support in the MS. The technical proposals on 
the selection of substances to monitor and the guidelines for monitoring would be forwarded 
to the Water Directors for endorsement at one of their twice-yearly meetings. 

4.4.4.  Option C3: Establish a watch list with legal obligation 

This option would entail establishing a watch list through a legally binding instrument. This 
would  involve  a  legal  provision  that  establishes  the  watch  list  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  process  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 administrative procedure that would, because of the need for substance-
specific updates, reduce the usefulness of the watch list, limiting the frequency of renewal and 
thus  its  effectiveness  at  meeting  the  objective  of  “improving  the  knowledge  base”.  Formal 
adoption of technical guidelines would also not be consistent with what the Commission and 
the MS have been doing over the 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  administrative  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  view  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) address different problems and are of a different 
nature. For this reason, this section sets out the analysis of impacts for the options in set A, 

27 

EN 

http://circa.europa.eu/Public/irc/env/wfd/library?l=/framework_directive/implementation_documents/fi
nal_2010-2012/_EN_1.0_&a=d  

30 

   EN 

 
                                                 
then a comparison of those options; then does the 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  regards  effectiveness  at  reaching  the  general  and 
specific objectives set out in section 3. The options are compared relative to the "no-change" 
options A1, B1 and C1; the baseline is explained in section 2.5. 

5.2. 

Analysis of impacts of the substance options 

5.2.1.  General considerations as regards costs and benefits of the substance options 

Annex IV includes a summary of the approach used to assess the impacts. 

Although  specific  measures  are  not  proposed  in  the  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  potential  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 regarding the measures that might be applied, a largely 
qualitative  approach  was  taken  in  the  analysis.  This  appears  proportionate  considering  the 
limited  direct  effects  of  the  proposed  options,  the  fact  that  the  decision  processes  regarding 
action under other sectoral EU legislation usually include a socio-economic analysis, and the 
fact  that  MS  can  apply  exemptions  regarding  attainment  of  the  environmental  objectives 
under the WFD (see section 5.2.1.2). 

Nevertheless,  to  the  extent  possible,  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  general,  rectification  at  source  is  more  cost-
effective  than  end-of-pipe  solutions.  The  importance  of  considering  upstream  measures  was 
highlighted  by  MS  and  stakeholders  during  the  consultation;  they  also  stressed  the  need  to 
consider the feasibility of phasing out certain substances 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 impacts of the individual substance 
options. 

Since  the  options  do  not  specify  measures,  the  assessment  of  the  potential  benefits  of 
measures themselves (as compared with the benefits 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 

31 

   EN 

 
•  Regular  monitoring  and  consequently  increased  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,  including  by  feedback  from  monitoring,  to  limit  chemical 
emissions, with consequent improvements 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  removal  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  ecosystems  and  organisms,  including  through 
migration. 

•  Cleaner sediments (including as a result of remediation informed by monitoring) meaning 
less  potential  for  re-dissolution  in  the  water  column  and  reduced  uptake  of  harmful 
substances by plants and animals. 

Economic benefits 

•  Moving towards a level playing-field for industry 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.  National  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 order 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 the 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 percentage 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  these  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  management  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 
€/m3.  Assuming  that  10%  of  the  material  is  contaminated  (value  from  the  Port  of 

EN 

32 

   EN 

 
Rotterdam)  and  hence  requires  higher  disposal  costs  in  the  range  of  10  to  30  €/m3,  the 
annual expenditure in handling contaminated dredged material is in the order of 200 to 600 
million € per year. The potential cost savings in the long term are therefore significant. 

•  The potential for healthier, more productive commercial fisheries and aquaculture. 

•  Fostering of innovation to find substitutes for PHS. 

Social and public health benefits 

•  More information for the public on the 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 (tourism, angling, etc), and reduced exposure for 

humans using them for bathing, surfing and other water sports; 

•  Cleaner  water  for  livestock  where  surface  water  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  additional 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 Model 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 assessment of the other potential costs of the 
options can only be based on potential measures that might be taken 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 legislation, 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 producers) beyond the baseline.  

EN 

33 

   EN 

 
For  the  other  substances  proposed  for  addition  to  the  PS  list  or  a  more  stringent  EQS, 
measures  beyond  the  baseline  might  be  taken  under  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 receiving water body, its uses and other discharges. It 
should be noted that the majority of UWWTPs provide only "simple treatment", but that MS 
are already obliged to upgrade certain plants to secondary treatment according to Article 4 of 
the  Urban  Waste  Water  Treatment  Directive  and  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 certain exemptions, i.e. if measures to achieve the 
WFD  objectives  are  technically  unfeasible,  disproportionately  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 used for specific water bodies if all conditions listed in those 
Articles are fulfilled. This provides MS with a legal safety net to deal with specific situations 
in which the costs of achieving the environmental objectives would significantly exceed the 
benefits  –  it  is  for  MS  to  carry  out  this  assessment.  Guidance  on  applying  exemptions  is 
available28.  Although  exemptions  relate  to  WFD  environmental  objectives  and  thus  to  the 
obligations on MS, they can potentially indirectly apply to emissions by individual operators. 
Whether  MS  would  be  able  to  take  the  operators'  position  into  account  would  depend  upon 
the justification provided, since the overall exemption would have to be justified to the public. 

As  indicated  in  section  5.2.1,  little  quantitative  information  was  received  for  many  of  the 
substances.  It  seemed  inappropriate  to  attempt  a  quantitative  analysis  combining  those  data 
with  the  uncertain  policy  outcomes,  bearing  in  mind  the  other  points  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,  the  impacts  on  EU  companies  (see  the  following 
sections and especially section 5.7) would be expected to be relatively 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 level should create a more level playing field for the MS than 
when  only  a  few  MS  set  an  EQS  or  the  national  EQS  are  very  different.  As  stated  above, 
exemptions  applied  by  MS  could  indirectly  apply  to  companies  and  thus  keep  costs  within 
proportionate  limits.  Other  reasons  for  not  expecting  impacts  on  competitiveness  are  that 
relatively  few  substances  are  involved  compared  with  the  total  number  on  the  market; 
substitution  is  not  seen  as  a  likely  requirement  (beyond  the  baseline)  for  most  of  the 
substances in the options, either because they are already heavily regulated 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 involved are large (even multinational) and have an 

28 European Commission, 2009b 

EN 

34 

   EN 

 
                                                 
extensive  product  portfolio;  substitutes  generally  exist  where  necessary  (further  information 
appears under the individual options below), and the need for measures to control emissions 
to the aquatic environment from many of the substances is also acknowledged in other parts 
of  the  world,  e.g.  in  at  least  Australia29,  Canada  (see  footnote  15)  and  the  USA30  regarding 
Cypermethrin, in at least the USA regarding pharmaceuticals31 (although no standards have so 
far  been  set),  worldwide  regarding  the  designated  POPs.  Although  Quinoxyfen  use  is 
currently still authorised in Australia, the instructions for use are strong on the need to avoid 
any emissions to water.  

Additional  costs  to  producers  could  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 the 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 additional treatment, or of cleaner energy.   

Small  and  medium-sized  enterprises  (SMEs)  that  might  be  affected  by  the  options  include 
pesticide  and  coating  formulators,  textiles  and  plastics  companies,  construction  companies, 
dockyards,  ship  owners,  fishermen,  arable  and  salmon  farmers,  pharmacies,  waste 
management  companies,  and  water  companies.    However,  with  the  exception  of  the  water 
companies,  as  explained  further  in  the  context  of  options  A2  and  A3c,  they  would  not  be 
expected to face significant costs beyond the baseline. 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  SMEs  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 proposed 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 EQS 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 regarding the cost and possible impacts of substitutes, where 

relevant; 

29  
30 

31  

EN 

http://www.apvma.gov.au/products/review/docs/sheep_ectoparsiticide_prelim_report_vol_2.pdf  

http://www.swrcb.ca.gov/rwqcb5/water_issues/tmdl/central_valley_projects/central_valley_pesticides/c
riteria_method/cypermethrin/2011mar_cypermethrin_draft.pdf  
http://water.epa.gov/scitech/swguidance/ppcp/index.cfm  

35 

   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  despite  the  comprehensive  consultation  carried  out 
(see section 1.4) to gather the necessary data and information to underpin the analysis. 

During the consultation, MS and stakeholders 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  did  not  pursue  an  early  proposal  to  calculate 
concentrations on the basis of surface water volumes to quantify the possible exceedance of 
the  proposed  EQS  in  "missing"  MS.  The  approach  of  using  case  studies  to  support  the 
assessment of impacts (see Annex IV) was designed to some extent to overcome this. 

Still, a few stakeholders considered that the extent of the monitoring data for some substances 
(Cypermethrin, EE2, Quinoxyfen) did not justify prioritisation. For Cypermethrin, 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  may  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  case,  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 monitoring-based prioritisation.  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  monitoring  and  modelling-based 
prioritisation processes is provided in the Commission Staff Working Paper SEC(2011)1544 
(European Commission 2011).  

Although the starting point for consultation was the membership of WG E, therefore mainly 
stakeholder  groups,  several  individual  companies  were  contacted  also  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 meetings and provided some 
input directly to the technical work on EQS derivation. However, despite repeated requests for 
information  for  the  substance  impacts  reports,  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: Change EQS and/or status of existing PS 

The impacts of this option over and above the baseline include those associated with changes 
to  (i)  the  EQS  (ii)  the  monitoring  matrix  and  (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  required  and  the  sectors  involved  would  depend  on  the 

EN 

36 

   EN 

 
substance.  The costs would depend on the type of measure and 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  integrative  character  of  biota.  The  impact  of  this  option  on 
monitoring costs is therefore estimated to be neutral, although there would be some adaptation 
costs for MS which have not previously monitored routinely in biota. Currently the choice of 
matrix is left to MS and therefore it is not appropriate 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  persistence  and  bioaccumulation  potential  would 
encourage MS to monitor in biota, improve knowledge 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  suitable  matrix,  would  come  from:  their  no  longer  needing  to 
develop  their  own  standard,  for  which  many  lack  the  expertise.  Differences  between  MS 
would  also  be  reduced  (a  preliminary  assessment  of  national  EQS  in  14  MS  shows  that  the 
national EQS for 35 substances differ by at least 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 relevant measures at Community level. 

5.2.3.4.  Summary of specific impacts per substance 

The table below summarises the specific 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  and  PolyBDEs  would  be  expected  to  improve 
with the expected shift from water to biota monitoring. 

#  Substance 

(main uses) 
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.) 

Baseline* and proposed 
change 
PHS; 
possible inclusion in 
REACH Annex XIV; 
IED, waste legislation; 
POPs Regulation – could 
all reduce emissions. 

Change: MAC-EQS 

5  Poly-BDE 

(Main use as flame 
retardants in polymers and 

PHS; 
POPs (4 congeners); 
REACH; IED; waste 
legislation (new limits 

Summary of significant 
specific impacts 
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.  
Positive: Encouragement 
to MS to monitor in biota 
instead of monitoring 
(ineffectively) in water, 

Remarks re substitution, 
SMEs, notable uncertainties 
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. 

Most impacts in baseline. 
Substitutes exist. 
As regards SMEs: Possible 
local impacts on water 

EN 

37 

   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 

12 DEHP 

(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 legislation – 
could all reduce 
emissions32. 

Change: Status 

20 Lead 

(Main use in batteries, 
accumulators, shot, ship 
keels, construction 
materials etc.) 

PS: 
REACH (Evaluation of 
Registration dossier); 
IED; waste legislation – 
have potential to reduce 
emissions. 

Change: EQS 

22 Naphthalene 

(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 

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. 
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. 
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.  
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 

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). 

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. 

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. 

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 

38 

   EN 

 
 
 
 
 
 
 
 
                                                 
 
23 Nickel 

(Main use in alloys, metal 
plating, batteries, steel 
manufacture.) 

PS; 
REACH (Evaluation of 
Registration dossier); 
IED; waste legislation – 
have potential to reduce 
emissions. 

Change: EQS 

28 PAHs 

(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 

15 Fluoranthene 

(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 

33 Trifluralin 

(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 

magnitude higher than 
AA-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 ) 
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. 

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. 
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.  

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. 

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. 

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. 

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 information on other relevant 
legislation in baseline. 

The main positive and negative impacts of this option are summarised in the table in section 
5.3.  

EN 

39 

   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 likely to drive local upgrades of 
industrial and/or urban WWTPs, and better control of industrial discharges into urban sewer 
systems. The need would have to be assessed at local level, as the impact would depend on 
local  conditions  (nickel  bioavailability  and  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 discharges in the basin, etc). Application of a 
biotic  ligand  model  (a  tool  to  determine  bioavailability  on  the  basis  of  the  environmental 
conditions)  to  available  monitoring  data  shows  potential  significant  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  Nickel  concentrations  of  the 
combination  of  environmental  conditions  .  Datasets  containing  the  necessary  information  to 
calculate  bioavailability  show  negligible  impact  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  attendant  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  EQSbioavailable  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-Group  on  PS  as  a  whole.  The 
importance of considering bioavailability and natural background concentrations was stressed 
by MS and stakeholders during consultation. Industry provided estimates suggesting that the 
number of industry installations that would fail to comply with an EQS of 2 μg l-1 would be 
significantly  greater,  depending  upon  the  sector,  than  the  number  failing  to  comply  with  an 
EQS of 4 μg l-1. For example, in 12 out of 16 sectors, 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 bioavailability 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  are  relatively  minor.  As  in  the  case  of  some 
other substances, the outcome of the REACH authorisation process for DEHP, which is used 
as  a  plasticiser,  largely  in  the  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 technologies are economically and technically viable. This would be 
consistent  with  PHS  designation  and  contribute  to  the  WFD  objective  of  phasing  out 
emissions  to  the  aquatic  environment.  However,  as  noted  in  the  above  table,  DEHP  is 
widespread in existing construction materials in situ.  A high proportion of its use is indoor, 
for example in flooring and flexible 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 PVC common in window frames, guttering and downpipes is, according 
to  the  information  available,  largely  unplasticised  (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  timeline  could  still  imply  a  need  to  replace 
existing  (in  situ)  construction  materials.  However,  any  such  action  would  be  subject  to 
consideration  of  the  costs.  Exemptions  regarding  the  20  year  deadline  could  be  applied,  as 
explained  above,  on  the  grounds  of  disproportionate  costs  or  technical  non-feasibility.  The 
assessment of early (before end-of-life) replacement costs would need to take into account the 

EN 

40 

   EN 

 
disposal/recycling costs, including those to the environment. 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 available33.  

Regarding other existing PS: On Trifluralin, comments 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 clearly 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: Existing-PS changes plus Annex III substances 

As options for substances are cumulative, this option includes all impacts 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 existing PS in EU 27, see Annex IV). 

5.2.4.1.  Summary of specific impacts per substance 

The table below summarises the specific impacts 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 allow better targeting of sediment remediation. 

Substance 

Baseline*  

Dicofol 

PFOS 

Quinoxyfen 

POPs legislation 
could become 
relevant. 
Recently excluded 
from Annex I of 
Directive 
91/414/EEC; 
emissions to water 
likely to fall. 
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. 
Regulation (EC) No 
1107/2009 criteria re 

33 European Commission, 2009b 

Summary of significant specific 
impacts 
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).  

Remarks re substitution, SMEs, notable 
uncertainties 
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. 

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. 

Positive: See text above table. 
Feedback to PPP policy. Benefits 

Substitutes exist (including improved 
management practices), though question 

EN 

41 

   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).  

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. 

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: extent of failure of EQS 
in absence of widespread monitoring to 
match widespread authorisation; possible 
decline in use as a result of resistance. 
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 information on other relevant 
legislation in baseline.  

The main positive and negative impacts of this option are summarised in the table in section 
5.3. 

impacts  on 

there  would  be  negative 

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  will  need  to  be  reviewed.  The  results  of  the 
prioritisation process under the WFD will be provided 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, 
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 fewer for hops than for other crops. There is some 
concern that resistance to another 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 achieved, compatible with the timescales over which 
industry  could  be  expected  to  develop  additional  products  and/or  strategies  to  overcome 
resistance problems. It should also be noted that 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  regarding  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 monitoring data (see section 5.2.2). 

Apart from monitoring costs, no other significant impact of this substance option is expected 
compared with the baseline. 

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5.2.5.  Analysis  of  impacts  of  Option  A3b:  Existing-PS  changes  plus  Annex  III  substances 

plus other new substances excluding pharmaceuticals 

As options for substances are cumulative this option includes all impacts 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 monitoring of PS in EU 27, see Annex IV). 

5.2.5.1.  Summary of specific impacts per substance  

The table below summarises the specific impacts 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 heptachlor) are proposed as  PHS. As  in option 
A3a,  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, in the case of the two proposed PHS, allow 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 

Aclonifen 

Bifenox 

PPP legislation. 
Recent introduction 
of compulsory buffer 
strips under Directive 
91/414/EEC, NAPs 
due under 
Sustainable Use 
Directive – could 
reduce emissions. 

PPP legislation: 
NAPs due under 
Sustainable Use 
Directive  - buffer 
strips and other 
measures could 
reduce emissions. 

Positive: See text above table. Feedback to 
PPP policy. Benefits for aquatic biodiversity 
from enforciing the EQS. 
Negative: Stricter requirements might be 
needed locally to meet the EQS.  

Positive: See text above table. Feedback to 
PPP policy. Benefits for aquatic biodiversity 
from enforciing the EQS. 
Negative: Stricter requirements might be 
needed locally to meet the EQS.  

Remarks re substitution, 
SMEs, notable uncertainties 
As regards SMEs: A need to 
take additional 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. 
As regards SMEs: A need to 
take additional 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. 

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Substance 

Baseline* 

Summary of significant specific impacts 

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. Increased shipping fuel 
costs/CO2 etc emissions if alternatives less 
effective. Additional costs might be passed on 
to consumers/passengers. Potential local 
impacts if sediment remediation is needed.  

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. 

Dichlorvos 

Biocidal Products 
Directive – under 
review; outcome 
could affect 
authorisation. 
Recently excluded 
from Annex I of 
Directive 
91/414/EEC  

Positive: See text above table. Feedback to 
biocides policy Benefits 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.  

Remarks re substitution, 
SMEs, notable uncertainties 
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. 
As regards SMEs: A need to 
take additional 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. 
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. 

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Substance 

Baseline* 

Summary of significant specific impacts 

HBCDD 

Heptachlor/ 
heptachlor 
epoxide 

Terbutryn 

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 

POPs legislation 
(including ban under 
Regulation (EC) No 
850/2004)) and 
exclusion from 
Annex I of Directive 
91/414/EEC 
responsible for 
reducing emissions.  
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. 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 sediment remediation 
undertaken.  

Positive: See text above table. Feed back to 
the biocides policy. Benefits to biodiversity, 
and to angling. Sustainable Urban Drainage 
(SUDs) could have shared benefits, e.g. flood 
control, energy saving.  Stimulation of 
innovation in construction to minimise need 
for biocidal coatings. 
Negative: Installation and maintenance of 
SUDs (variable costs depending upon type). 
Costs of  substitutes if needed. 

Remarks re substitution, 
SMEs, notable uncertainties 
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). 
Uncertainty re extent of failure 
of proposed EQS in several 
MS in absence of sufficiently 
sensitive analytical method. 
No negative impacts on SMEs 
expected. 

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 information 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 result in the restriction of certain uses for 
PPPs or biocides, hence triggering substitution costs. 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  difficult  (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  Organisation's  International  Convention  on  the 

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Control of Harmful Anti-fouling Systems on Ships34 might need to be considered if national 
measures were not sufficient to allow achievement 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  substitutes,  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 industry stakeholder as explained 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 impacts 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 monitoring of PS in EU 27, see Annex IV). 

5.2.6.1.  Summary of specific impacts per substance 

The  three  additional  substances  in  this  option  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  Annex  V.  For  these  substances,  as  in  the  other 
options, a significant benefit of PS status is that WFD monitoring would provide information 
on the extent of the problem and the effectiveness of any measures taken. This would in turn 
provide  feedback  to  pharmaceuticals  policy.  Since  pharmaceuticals  have  not  hitherto  been 
regulated under the WFD, their regulation would bring new elements into play, notably public 
health  considerations.  The  three  substances  under  consideration  are  different  in  character 
(uses,  sources,  alternatives)  and  therefore  also  from  a  regulatory  point  of  view  (see  Annex 
VI). 

Substance 

Baseline* 

17 alpha-
ethinylestradiol 

Urban Waste Water 
Treatment Directive 
(UWWTD). 
Pharmaceuticals 
(including 
pharmacovigilance) 
legislation. 
Take-back schemes. 

Summary of significant specific 
impacts 
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, 

Remarks re substitution, SMEs, 
notable uncertainties 
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 prescription practices) would 
involve medical practices and 
pharmacies but would be unlikely to 
have any significant negative impacts. 

34  

http://www.imo.org/about/conventions/listofconventions/pages/international-convention-on-the-
control-of-harmful-anti-fouling-systems-on-ships-(afs).aspx  

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Substance 

Baseline* 

Summary of significant specific 
impacts 
but overall market maintained. 

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. 

Diclofenac 

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 and/or livestock 
farmers need to fence water 
courses beyond the requirements 
under other legislation. (See text 
below re possible costs.) 
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. 

Remarks re substitution, SMEs, 
notable uncertainties 
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 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. 
Substitution of limited relevance. 
As regards SMEs: Livestcok farmers 
could face additional costs for fencing 
water courses. Expansion of take-back 
schemes (limited relevance 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. 

Substitute NSAIDs exist 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 prescription 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; uncertain impacts. See Annex V for additional information on the 
baseline.  

All three have been used for several years as pharmaceutical ingredients, and 17 beta-estradiol 
(E2)  is  also  naturally  excreted  by  humans  and  other  mammals.  The  benefits  deriving  from 
their pharmaceutical application are reflected in their widespread use. However, they can pose 
a significant risk to the aquatic environment if their concentration is higher than the proposed 
environmental quality standard, as is found and has been indicated in section 2.2.3. 

Although their addition to the PS list would be aimed principally 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  possible  to  assess  the  costs  and 

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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-pipe treatment (improvement of UWWTPs). 
source-control measures might be more cost-effective. 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  disposal  of  unused  products.  In  the  absence  of  good 
knowledge regarding the functioning of these schemes, including of their 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 suggest that there is room for improvement  (as confirmed by 
the  Pharmaceutical  Group  of  the  European  Union).  This  could  significantly  reduce  the 
emissions of Diclofenac and EE2. 

Another  approach  to  consider  would  be  the  promotion  of  more  environmentally-friendly 
alternatives.  For  example,  several  Non-Steroidal  Anti-Inflammatory  Drugs  (NSAIDs)  exist 
that  could  be  used  instead  of  Diclofenac,  with  similar  therapeutic  efficacy35  but  allowing 
easier  removal  in  conventional  UWWTPs  (Roig 2010).  Information  to  patients,  doctors  and 
pharmacists about the environmental impact of medicines could influence 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  significant  impact  on  the  prescription  behaviour  of 
health professionals, although comprehensive information on the success of the scheme is not 
available (Knappe 2008). 

The oral pharmaceutical alternative 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  100  women).  However,  the  EE2-
based pill is not replaceable in all cases by the progestogen-based mini-pill.. Progestogens are 
also endocrine disrupting substances 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 would 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-inflammatories-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;  the  Prescription  Guide  of  the  Spanish  Medicament 
Agency  http://www.imedicinas.com/GPTage/Open.php?Y2ExMHNlMDFzYjAx  that  indicates  that 
"differences in anti-inflammatory activity of different NSAIDs are small, but there is great variation in 
tolerance  and  response  of  each  patient.  Approximately  60%  of  patients  respond  to  any  NSAID,  and 
40% respond to one or another". 

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from now, and that there are possibilities for exemptions to extend the deadline on grounds of 
disproportionate  cost  or  technical  non-feasibility.    As  noted  above,  guidance  on  applying 
exemptions is available36.  

It  is  however  not  possible  to  estimate  how  much  end-of-pipe  treatment  would  be  needed 
across  the  EU.  This  is  very  much  dependent  on  local  conditions.  Nevertheless,  some  cost 
estimates  for  upgrading  UWWTPs  to  remove  E2  are  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 (sometimes 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 CO2 in England and Wales, an increase 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 implying 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 possible to estimate how much fencing would be 
required in total.  The costs could fall largely on livestock farmers (generally SMEs) but be 
attributed in part to requirements under other legislation such as the Nitrates Directive. 

As mentioned above, not only the costs but also the benefits of applying measures (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  presented  in  section  5.2.1.1  including  the  value  of  a 
resilient aquatic ecosystem, significant benefits from meeting 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  uncertainties  suggest  that  until  further  monitoring 
data have been gathered to inform the policy making, it would not be appropriate to propose 
measures at EU level; measures to influence prescription 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 Diclofenac in the list of 

36 European Commission, 2009b 
37 See Entec 2011, report for E2, Appendix B. Per capita cost calculated on the basis of average annual costs and 

54 million inhabitants in England and Wales. 

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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  the  environmental  impact  of  pharmaceutical 
products.  On  the  other  hand,  the  environmental  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 objectives 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 negative 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. 

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. 

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. 

EN 

50 

   EN 

 
 
 
 
Option 

Effectiveness 

Main positive impacts  

Main negative impacts  

A3a: Existing 
PS plus Annex 
III substances 

A3b: Existing 
PS plus Annex 
III plus other 
new excluding 
pharmaceuticals 

++ 

As above plus: 

As above plus: 

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. 

Information about the presence 
of and  extent of the risk caused 
by the additional substances and 
about the effectiveness 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. 

Estimated additional 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. 

+++ 

As above plus: 

As above but: 

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. 

Valuable data and information 
for decision making in the 
context of the biocides policy 

Estimated additional monitoring 
costs of 12 – 28.8m € per year, 
which would fall on MS; 

Additional protection of human 
health and aquatic biodiversity. 

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 

++++ 

As above plus: 

As above but: 

Improved knowledge of the 
extent of the risks from existing 
PS (through the setting of biota 
standards for poly-BDE, PAH 
and Fluoranthene) 

Improved information on the 
extent of pollution by 
pharmaceuticlas, and  EU-wide 
EQS as benchmarks for deciding 
measures at MS level.  

Estimated additional monitoring 
costs of 15 – 36m € per year, 
which would fall on MS; 

plus: 

Additional protection of human 
health and aquatic biodiversity. 

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. 

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  identified  at  EU  level,  and  option  A3c  achieves  the 
objectives  to  the  greatest  extent  as  it  contains  the  complete  outcomes  of  the  prioritisation 
process. Option A3c is therefore the preferred option. 

EN 

51 

   EN 

 
 
If MS found that disproportioante costs would be incurred locally, 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. According to the available information, though, it is 
unlikely that such disproportionate costs would arise 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  included  as  RBSPs  or  be  affected  by  measures  for 
other substances. 

Option A3c ensures gathering of data to inform measures locally and possibly 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 required to inform this decision, as 
well  as  the  monitoring  required  to  judge  the  effectiveness  of  any  measures.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 simplicity, overestimates the costs for the options 
with the largest number of substances. These will have a better cost ratio per substance since 
sampling costs  increase less steeply as the number of substances increases. Further, should 
upgrades  to  UWWTPs  be  required,  or  sediment  remediation  be  undertaken,  the  costs  per 
substance would decrease, i.e. they should not be multiplied by the number 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  the  problems  relating  to 
ubiquitous PBTs was welcomed particularly by MS, but also by stakeholders.  

5.4.1.  Analysis  of  impacts  of  Option  B2a  on  presentation:  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  not  considered  significant.  As  regards  potential 
negative  impacts,  as  this  option  would  not  oblige  MS  to  present  PBTs  separately,  some 
discrepancy in presentation of the results between MS might occur.   

In terms of benefits, the flexibility in the presentation 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  that  the  RBMP  are  subject  to 
compulsory public consultation.  

5.4.2.  Analysis  of  impacts  of  Option  B2b  on  presentation:  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  would  be  no  EU  EQS  and  no  driver  for  taking 
measures. 

EN 

52 

   EN 

 
The first implementation cycle of the WFD has not yet ended . Changing the goal posts before 
the 2015 deadline for achieving the objectives would create legal uncertainty. This option is 
also not fully consistent with the general objectives 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  Directive.    However,  it  would  be  a  very 
straightforward way of addressing the problem of presentation. 

The  environmental  NGOs  expressed  concern  about  both  options  B2a  and  B2b  effectively 
because they considered that less attention would 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 should be the intrinsic properties of the substance 
and  its  environmental  fate,  together  with  the  possibilities  to  effectively  monitor  the 
environmental concentrations to manage risks. However, 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  national  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 about  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  emission  limits  in  the  permits  for  waste  water 
discharges,  even  when  far  below  the  sensitivity  of  state-of-the-art  analytical  techniques. 
Where it is possible to monitor reliably 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 substances 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 straightforward 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 substance 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 preferred 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 without experience in monitoring and analysing 
specific  substances  in  certain  matrices.  There  would  be  no  possibility  to  adapt  quickly  to 

EN 

53 

   EN 

 
progress in analytical techniques that could improve the sensitivity in certain matrices. This 
could hinder progress in the development of analytical techniques for these other matrices. 

One of the advantages of this option is the legal 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 order to ensure comparability of results. 

5.4.5.  Analysis  of  impacts  of  Option  B4a  on  monitoring:  Introduce  reduced  monitoring 

obligations for ubiquitous PBTs if certain specified conditions are met  

Costs could be saved because of reduced monitoring effort and reduced administrative burden 
for  MS;  the  justification  for  the  reduced  effort  would  be  in  the  EU  legislation.  The  option 
could cover up to 8 ubiquitous PBTs (the 4 existing 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 between 20 and 30% of the 
monitoring  costs.  This  is  a  conservative  estimate,  since  the  default  frequency  in  water  is 
monthly (WFD Annex V) and in sediment and biota it is annually (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  between  50%  and  90%.  In  addition  there  could  be 
additional  savings  by  reducing  the  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 monitoring baseline in all MS, the potential 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 existing 4 ubiquitous PBTs in the 20-30% range, 0.8 
to 2.9 million € per annum could be saved across the EU (between 1 and 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 administrative effort for all or several of their RBDs 
(e.g. UK, IE, AT, PL, PT, NL). If this were taken 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  monitoring:  Introduce  reduced  monitoring 

obligations for ubiquitous PBTs (unconditional) 

In the long term, the reductions in monitoring costs and administrative burden would likely be 
the  same  as  those  under  option  B4a.    However,  the  absence  of  a  requirement  for  a  robust 
baseline could reduce the monitoring costs still further in the short 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  differences  for  some  substances  could  be  large 
(e.g. in water bodies that were/are subject to direct emissions compared with water bodies that 
are impacted by atmospheric deposition). 

EN 

54 

   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 B2b,  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,  taking  account  of  the  objectives  in  section  3  and  the  existing 
legislation. 

Option 

Effectiveness 

Efficiency  

Consistency 

B1: No change 

0 

Options on presentation 

B2a: More 
flexibility on 
presentation 

++ 

Avoids presentational issue 
although formally chemical 
status would still be affected 
by the ubiquitous PBTs. 

0 

++ 

Efficient as no major costs 
involved and reduced 
administrative burden for MS. 

0 

+ 

Retains coherence 
with the objectives of 
the WFD, providing 
more flexibility in 
terms of presentation 
of information on 
status. 

Overall 
mark 

0 

+++++ 

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 

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. 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. 

++ 

- 

≈ 

+ 

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 

55 

   EN 

 
Option 

Effectiveness 

Efficiency  

Consistency 

B4a: Reduced 
monitoring 
obligations if certain 
specified conditions 
are met 

B4b: Reduced 
monitoring 
obligations 
(unconditional) 

+ 

+ 

Reduces administrative burden 
and monitoring costs for MS.  

Ensures that a robust 
monitoring baseline is 
available, hence contributing 
to good knowledge of the 
risks to or via the aquatic 
environment of ubiquitous 
PBTs. 

+ 

≈ 

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. 

≈ 

≈ 

Overall 
mark 

++ 

+ 

Magnitude  of  impact  as  compared  with  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: Establish a watch list without legal obligation. 

Monitoring costs would be the most important costs 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 from 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 additional 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 attributable to the option 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 the outcome due to pressures on 
MS to prioritise legal 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 therefore the usefulness of the expenditure would 
decline significantly. 

5.6.2.  Analysis of impacts of Option C3: Establish a watch list with legal obligation 

The  costs  of  this  option  would  be  similar  to  those  for  option  C2.  However,  there  would  be 
some additional costs for comitology and administration within the Commission. 

EN 

56 

   EN 

 
The  legal  obligation  would  make  the  outcome  more  certain  to  meet  the  objectives,  i.e.  to 
provide EU-wide datasets, and ensure fairer 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 for legal obligation, 3 for voluntary approach, 5 no 
position). 

5.7. 

Comparison of the options to improve the knowledge base 

Option 

Effectiveness 

Efficiency  

C1: No change 

C2: Establish a 
watch list 
without legal 
obligation 

C3: Establish a 
watch list with 
legal obligation 

0 

+ 

0 

+ 

Increased knowledge but likely to suffer 
important data gaps (incomplete coverage 
of MS) and lack of adherence to technical 
specifications due to the voluntary 
character. 

Value for money (i.e. return on MS 
administrative - including monitoring - costs)  
limited by the likelihood of data gaps. 

++ 

++ 

++++ 

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. 

Overall 
mark 

0 

++ 

Magnitude  of  impact  as  compared  with  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  across  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 net increase in monitoring 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 (Nickel and E2). Since there would likely be 
an overlap between the locations (with high 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  were  implemented  for  Nickel  and  E2  they 
would  also  have  a  positive  impact  on  reducing  the  emissions  of  other  pollutants 

EN 

57 

   EN 

 
 
 
 
covered in this impact assessment (e.g. Lead, DEHP, BDEs, HBCDD), other existing 
PS  (Mercury,  Cadmium,  Nonylphenol,  etc)  and  many  other  pollutants,  representing 
good  value  for  the  investment  by  public  authorities  or  private  companies  (and 
indirectly the consumers). 

•  As regards options for substances 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  would  imply  for  those 
substances  would  result  in  higher  rates  of  failure  of  EQSs.  This  would  however 
provide  a  more  accurate  picture  of    the  risks  posed  by  those  substances  and  of  the 
effectiveness  of  measures  taken,  and  would  allow  MS  to  take  better-informed 
decisions on the need to undertake remediation at contaminated sites.  

o  The extent to which the options addressing presentational aspects of ubiquitous PBTs 
would have an impact would depend upon the choice of substance option; the impact 
would be greater, the more cumulative the substance option, since it would relate not 
only to stricter EQS for existing substances but also additional ubiquitous PBTs.  
o  If the ubiquitous PBTs were taken out of the chemical status assessment (option B2b), 
the general objective of  reducing 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 selected, 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). The 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 PBTs 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 long term). The value for money, though, would 
be significantly greater for the watch list. 

•  As  regards  the  sub-options  for  ubiquitous  PBTs:  Although  the  sub-options  on 

presentation, monitoring matrix and frequency are independent,  

o 

o  providing  flexibility  in  presentation  or  taking  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 applied); conversely, greater harmonisation 
of  the  monitoring  matrix  would  be  likely  to  lead  to  more  comparable  approaches  to 
presentation under the flexible presentation option. 
taking  the  ubiquitous  PBTs  out  of  the  chemical  status  assessment  would  already 
reduce the monitoring obligation to that required 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 would already reduce the monitoring frequency 
if  MS  were  previously  monitoring  in  water.    Therefore  the  additional  impact  of 
adopting one of the options on reduced monitoring frequency would be lower than if 
the matrix had not been fixed in biota. 

EN 

58 

   EN 

 
5.8.2.  Cumulative impacts of the package 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  substances  -  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 the following main benefits: 

o  all the latest scientific information reviewed would be taken into account; 
o  MS would be encouraged to monitor in biota when most appropriate; 
o  a more accurate picture would be obtained 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 ubiquitous PBTs among the existing PS, and of the 
effectiveness of measures for these substances, allowing introduction/improvement of 
measures  at  EU  and  MS  level,  better  targeting  of  sediment  remediation,  and 
optimisation  of  protection  from  identified  risks  -  thus  leading  to  benefits  to 
biodiversity and human health; 

o  measures applied to reduce the risks from some substances (e.g. Nickel) would be seen 

o 

o 

to reduce the risks from others (e.g. E2) as well; 
the  harmonisation  of  EQS  for  more  substances  would  provide  a  more  level  playing 
field for businesses in different MS; 
the administrative burden associated with explaining the failure of the chemical status 
objective  as  a  result  of  ubiquitous  PBTs  would  be  reduced,  and  the  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  improving  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  companies,  likely  passed  to  consumers,  of 
additional UWWT to remove Nickel and E2, costs to industry to reduce point source 
industrial emissions of Nickel, and costs to livestock farmers to install fencing to keep 
animals away from water courses to reduce E2 emissions to water, although some of 
those costs could fall under other legislation and would be within proportionate limits; 
estimates for the UK (which has among the highest Nickel concentrations in the EU) 
are:  whole-life  costs  of  the  order  of  2  billion  €  to  meet  a  2  μg  l-1  EQSbioavailable  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 UWWTPs, 20-year lifetime cost which is in net 
present value) to meet a 4 10-4 μg l-1 EQS for E2, plus attendant 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 estimated at between 2 and 12 €/ha/year (it 
is not possible to estimate how much fencing would be required in total, and at least 
some of the costs would fall under other legislation);   
the possible costs, unkown but not likely to be significant, of substituting Quinoxyfen, 
if authorisation not anyway withdrawn under the PPP legislation; these could fall on 
the producers, formulators, farmers and/or consumers depending upon the substitute; 

o 

o  approx 2-4 m € per annum to operate the watch-list. 

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Overall, the preferred options would 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 that 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 general objectives, although some relating to the latter are noted 
in the final bullet. 

•  Sector-specific 

o  Since  several  agricultural  PPPs  are  included  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  watercourses  to  reduce  E2  emissions  (see  above). 
On the other hand, farmers could benefit from improved ecosystem services. 

o  The preferred substance option would involve 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.  Nevertheless,  there  could  be  an  impact  on  the 
pharmaceutical sector in the long term if measures at MS level were taken to influence 
prescription  and  promote  pharmaceutical  alternatives  with  lesser  environmental 
impact. 

o  The  commercial  fisheries  and  aquaculture  sectors  could  be  affected  positively  by 
improved water quality and fish health.  The introduction of an EQS 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  address  end-of-life  aspects  of  some  products 
containing the proposed PS, e.g. HBCDD, and there 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  construction  sector  from  the  requirement  to 
meet an EQS for Terbutryn (although relevant measures are unlikely) 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  Nickel  could  involve  the  relevant  industry 
sectors (e.g. alloys, metal plating, batteries, pigments, other chemicals, stainless steel 
production, mining). 

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o  Impacts in the public sector would most obviously relate to monitoring costs, but some 
public  sector  investment  might  be  involved  also  in  infrastructure,  in  particular  the 
upgrading of UWWTPs where these are in public 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  risk  management).  Although  there  might  need  to  be  some 
public  investment  in  awareness-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 the disposal of unused 
pharmaceuticals.  Significant  impacts  on  employment  in  industry  would  not  be 
expected (see producer section below). Some employment opportunities might arise in 
sediment remediation and mechanical cleaning as a substitute for biocidal coatings. 

•  Producer and user-specific: 

o  The  overall  impacts  on  producers  are  difficult  to  assess,  because,  despite  extensive 
consultation,  it  has  not  been  possible  in  many  cases  to  determine  who  they  are 
(therefore the size and resilience/capacity for diversification of the enterprise, although 
most  of  those  identified  are  large)  or  where  production  is  located,  even  whether  it 
occurs  within  the  EU.    The  production  of  some  substances  (Dichlorvos,  Heptachlor, 
PFOS) no longer occurs in the EU. Dichlorvos and PFOS are manufactured in India 
and China, respectively and imported.  There 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 Trifluralin (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  occurs  in  the  EU.    Cybutryne  may  be 
produced  in  CH  by  a  large  DE-based  company;  Terbutryn  production  occurs  in  part 
outside the EU. It should be remembered that most substitution costs, including those 
relating to employment, would be in the baseline. 

o  There  could  be  impacts  on  formulators  of  some  PPPs  and  biocides,  including  the 
formulators  of  biocidal  coatings,  since  there  are  EU  formulators  for  most  of  these 
substances and they are not necessarily restricted to the MS where the substances are 
used.  However, other (existing 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 producers and formulators are covered under the 
previous  point.  An  additional  observation  is  that  trade  (import,  export)  with  third 
countries  is  unlikely  to  be  affected  significantly  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  restricted  under  the  baseline.  An  exception  could  be 
Quinoxyfen, depending upon where it is manufactured (information not available). 

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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), and this list could be 
indicative  of  the  MS  that  would  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.  Aclonifen  and  Bifenox,  and  is  also  among  the 
highest  users  of  Quinoxyfen  and  Cypermethrin.  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 correlation 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 effects 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  farming  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 pharmaceuticals, the effects on authorities (monitoring 
obligation initially); and in due course also on patients and medical 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.    Likewise,  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 (specifically salmon farming, 
i.e. in IE, UK, (NO) if using Cypermethrin). 

o  Impacts  related  to  substances  present  significantly  in  urban  waste  water  discharges 
(e.g.  BDE,  DEHP,  HBCDD,  Ni,  PFOS,  pharmaceuticals),  would  be  likely  to  be  felt 
mainly in MS with higher population density 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 extent 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  flexibly  present  the  results  of  monitoring 
ubiquitous  PBTs  should  by  definition  benefit  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  adaptation  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 obligations are introduced only for substances 
most relevant at that level. 

In  conclusion,  the  preferred  options  do  not  appear  to  have  significant  unfair  distributional 
impacts when the baseline is taken into account. 

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62 

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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 evaluation 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  River  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 written feedback from MS on the implementation 
and  effectiveness  of  the  Directive  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 next review due in four years. 

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ANNEX I: Glossary / List of acronyms 

AA-EQS  

Annual Average EQS 

BDE 

CIS 

Brominated Diphenylether 

Common Implementation Strategy for the Water Framework Directive 

CMEP  

Chemical Monitoring and Emerging Pollutants Sub-group of WGE 

COMMPS 

Combined Monitoring and Modelling-based Prioritisation 

CSTEE 

Scientific Committee on Toxicity, Ecotoxicity and the Environment 

DEHP   

Bis(2-ethylhexyl)phthalate 

DL-PCB 

Dioxin-like Polychlorinated biphenyl 

DOC 

E2 

EE2 

EEA 

Dissolved Organic Carbon 

17 beta-estradiol 

17 alpha-ethinylestradiol 

European Environment Agency 

EFPIA 

European Federation of Pharmaceutical Industries and Associations 

EQS 

EQSD 

Environmental Quality Standard, i.e. 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) 

Environmental  Quality  Standards  Directive  (Directive  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 (Directive 2008/1/EC of 
the  European  Parliament  and  of  the  Council  of  15  January  2008  concerning 
integrated pollution prevention and control) 

JRC 

Joint Research Centre of the European Commission 

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MAC-EQS  Maximum Allowable Concentration EQS 

MS 

NAP 

Member State(s) 

National Action Plan 

NSAID 

Non-steroidal Anti-inflammatory Drug 

OSPAR 

Oslo-Paris Convention for the protection of the North Sea 

PBT 

PCB 

PHS 

Persistent Bioaccumulative and Toxic 

Polychlorinated biphenyl 

Priority Hazardous Substance under the Water Framework Directive 

Poly-BDE 

Poly-Brominated Diphenyl Ethers 

POP 

PPP 

PS 

RAR 

RBD 

Persistent Organic Pollutants under the Stockholm Convention 

Plant Protection Product 

Priority Substance under the Water Framework Directive 

Risk Assessment Report 

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 European Parliament and of the Council 
of  18  December  2006  concerning  the  Registration,  Evaluation,  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  for  deriving  EQS  (European  Commission, 
2011b) 

UWWTD 

Urban Waste Water Treatment Directive (Council Directive 91/271/EEC of 21 
May 1991 concerning urban waste-water treatment) 

UWWTP 

Urban Waste Water Treatment Plant 

WFD 

Water Framework Directive (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 

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WG E 

Working  Group  E  on  Chemical  Aspects  (under  the  Strategic  Coordination 
Group for the Common Implementation Strategy of the WFD) 

WISE   

Water Information System for Europe (http://water.europa.eu)  

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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 identified among those causing a risk to or via 
the aquatic environment, by means of 

a. Risk assessment carried out under the chemicals, PPP and biocides legislation (Regulation 
(EEC) No.793/93, Directive 91/414/EEC and Directive 98/8/EC respectively) 

b. Targeted  risk  assessments  focusing  on  aquatic  ecotoxicity  and  on  human  toxicity  via  the 
aquatic environment 

c. Simplified risk-based assessment procedure based 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  widespread  contamination  such  as  production 

volumes and use patterns 

Some of the above points make particularly clear the importance of considering the route of 
exposure,  i.e.  substances  identified  as  PS/PHS  must  be  relevant  to  or  via  the  aquatic 
environment, not other environmental compartments alone. 

Summary of the prioritisation exercise and its results 

The first list of 33 PS was established 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  legislation.  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 modelling 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 prioritisation process to identify those most likely to 
cause  harm  to  or  via  the  aquatic  environment.  The  prioritisation  process  was  based  on  the 
criteria set out in the WFD Article 16(2) (see above), taking account of the experience gained 
with the COMMPS procedure used to establish the first list. An opinion40 on that procedure 

38  
39  

40  

OJ L3331, p 1, 15.12.2001 
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  
Opinion  on  the  revised  proposal  for  a  List  of  Priority  Substances  in  the  Context  of  the  Water 
Framework  Directive  (COMMPS  Procedure)  prepared  by  the  Fraunhofer-Institut  (Germany)  -  Final 

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from the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE), and 
discussions among Commission services, MS and stakeholder experts, were considered in the 
development by WG E of an improved methodology. 

A combination of different approaches was considered 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  extensive  monitoring  and  modelling  exercises.  In  the 
context  of  considering  assessments  under  other  legislation,  attention  was  also  given  to 
Substances of Very High Concern (SVHCs) under REACH, and substances of concern under 
the Convention on Persistent Organic Pollutants (POPs).  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 processes, which were subject to expert review in the Sub-Group on 
Review,  led  to  separate  but  complementary  lists  of  substances.    The  lists  or  at  least  the 
highest-priority  substances  on  each  list  were  amalgamated  and  subjected  to  a  short-listing 
procedure.  The range of processes took advantage of the most relevant available information.  
Inevitably  there  was  some  overlap  between  the  lists,  despite  the  independence  of  the 
processes,  and  this  made  the  case  for  prioritising  some  substances  particularly  strong.  The 
individual  prioritisation  processes  and  the  short-listing  procedure  were  followed  by  further 
shortlisting on the basis of detailed dossiers prepared by the Commission 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 legislation, 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 predicted 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  substances  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 reviewed on the basis of revised or finalised 
risk assessment reports and decisions made under other legislation. Consideration was given 
to observations from MS regarding analytical difficulties. 

In  setting  the  EQS,  use  was  made  of  the  revised  Technical  Guidance  Document  on  the 
Derivation  of  Environmental  Quality  Standards,  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  technical  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  plenary  meeting  on  the  28th  of  September  1999. 
http://ec.europa.eu/health/ph_risk/committees/sct/docshtml/sct_out49_en.htm  

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therefore technical grounds for regulating them under the WFD. (See also Annex V for more 
information on the substances.)  

CAS# 

57-63-6 

50-28-2 

Substance 
17 alpha-
ethinylestradiol 
17 beta-estradiol 

74070-46-5 

Aclonifen 

42576-02-3 

28159-98-0 

52315-07-8 

Bifenox 
Cybutryne (Irgarol®) 

Cypermethrin 

62-73-7 

Dichlorvos 

15307-79-6 

Diclofenac 

115-32-2 

Dicofol 

1746-01-6 

Dioxins (and dioxin-
like PCBs) 

3194-55-6 / 
25637-99-4 

HBCDD 

76-44-8/ 
1024-57-3 

Heptachlor/Heptachlor 
epoxide 

1763-23-1 
124495-18-7  Quinoxyfen 

PFOS 

886-50-0 

Terbutryn 

Main reasons for prioritisation as PS (or PHS) 
Endocrine disruptive; risk ratio >1 

Endocrine disruptive; risk ratio >1 
Ranked high in modelling based prioritisation; bioaccumulative and 
toxic (and some evidence of persistence); risk ratio >1 
Ranked high in modelling based prioritisation, very toxic, risk ratio >1 
Substance of concern in MS, toxic, risk ratio >1; degrades only slowly; 
main degradation product (M1) also toxic; persists in sediments. 
Ranked very high in monitoring-based prioritisation and high in 
modelling-based prioritisation; very toxic; risk ratio >1 
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. 
Toxic; risk ratio >1 
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.  
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. 
Ranked high in modelling-based prioritisation; PBT, SVHC under 
REACH, recommended POP, EU RAR conclusion of risk to aquatic 
environment. 
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. 
Annex III substance, PBT, POP, risk ratio >1 
PBT and vPvB properties 
Ranked high in modelling based prioritisation, medium in monitoring-
based prioritisation, toxic, risk ratio >1 

The  conclusions  of  the  assessment  of  new  technical  information  regarding  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 new risk assessment report or no grounds within 
such  a  report  to  make  a  (significant)  change  to  the  EQS  or  a  change  to  the  status  of  the 
substance. 

Substance 

PS 
no# 
2  Anthracene 

Rationale for review/nature of change 

Review of the EQSs prompted by revised RAR for pitch.  Conclusion that high 
acute toxicity justifies setting MAC equal to AA-EQS. 

EN 

69 

   EN 

 
 
 
 
 
 
Substance 

Rationale for review/nature of change 

PS 
no# 
5 

Poly (including octa) 
BDE 

12  DEHP 

15  Fluoranthene 

20  Lead 

22  Naphthalene   

23  Nickel 

28  PAHs 

Benzo(a)pyrene 
Benzo(b)fluoranthene 
Benzo(k)fluoranthene 
Indeno(1,2,3-
cd)pyrene 
Benzo(g,h,i)perylene 

33  Trifluralin 

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 
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 reduction measures). Change status to PHS. 
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. 
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. 
Review of the EQSs prompted by revised RAR for pitch. Conclusion that need 
slightly more stringent EQS for freshwater and introduction of MAC. 
New  information  (EU  RAR  2008,  SCHER  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. 
Review of the EQSs prompted by revised RAR for pitch. 
Conclusions:  Biota  EQS  is  critical  EQS  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  stringent  in  freshwater,  more  stringent  in 
saltwater. 

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  the  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  
42  
43  

OJ L348, p.84-97, 24.12.2008 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:52006DC0398:EN:NOT  
Lepper, 2005.  

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in the Directive but they too should offer at least the same level 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 guidance, 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 derived standards for existing and new substances. 

Proposed changes to EQS and status for existing PS: 

# 

Substance 

Proposed  AA-QS 
water 
µg/l (Existing) 

Proposed  MAC-
QS water 
µg/l (Existing) 

Proposed 
EQS 
µg/kg ww 

Biota 

Change 
to PHS? 

2 
5 

Anthracene 
Poly (including octa) 
BDE 

F  4.9 10-8 (0.0005) 
S  2.4 10-9 (0.0002) 

0.1 (0.4) 
F  0.14 (na) 
S  0.014 (na) 

12  DEHP 
15  Fluoranthene 
20  Lead 

22  Naphthalene   

23  Nickel 

28  PAHs 

Benzo(a)pyrene 

6.3 10-3 (0.1) 
F  1.2 bioavailable (7.2) 
S  1.3 bioavailable (7.2) 

0.12 (1.0) 
F  14.25 (na) 
S  14.25 (na) 

F  2.0 (2.4) 
S  2.0 (1.2) 
F  4 bioavailable (20) 
S  8.6 bioavailable (20) 

130 (na) 
130 (na) 
F  34 
S  34 

1.7 10-4 (0.05) 

0.0085 

30  

Yes 

Benzo(b)fluoranthene 

1.7 10-4 (0.03*) 

Benzo(k)fluoranthene 

1.7 10-4 (0.03*) 

Indeno(1,2,3-cd)pyrene 
Benzo(g,h,i)perylene 

1.7 10-4 (0.002**) 
F  8.2 10-3 
S  8.2 10-4 
(0.002**) 

33  Trifluralin 

Notes to the table: 

Benzo(a)pyrene as 
marker 
2 for fish 
5 for crustaceans 
and cephalopods 
10 for molluscs 

F  0.27 (0.1) 
S  0.027 (0.1) 
F  0.017 (na) 
S  0.017 (na) 
F  0.017 (na) 
S  0.017 (na) 

F  8.2 10-3 (na) 
S  8.2 10-4 (na) 

Yes 

−  PHS means priority hazardous substance 
−  F means freshwater 
−  S means other surface waters 
−  Eco means the standard is set for protection of ecology 
− 
− 
− 
−  The existing standards for the two PAH marked with (*) and the two marked as (**) are given in 

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 

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 

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   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Substance 

Dicofol 

PFOS 

Quinoxyfen (tbc) 

Dioxin 

Aclonifen 

Bifenox 

Cybutryne 
Cypermethrin 

Dichlorvos 

HBCDD 

Heptachlor/ heptachlor 
epoxide 
Terbutryn 

17alpha-ethinylestradiol 

17beta-estradiol  

Diclofenac 

Proposed  AA-QS 
water 
µg/l 
F  1.3 10-3 
S  3.2 10-5 
F  0.00065  
S  0.00013 
F  0.15  
S  0.015 

F  0.12  
S  0.012  
F  1.25 10-2  
S  1.25 10-3  
0.0025  
F  8.2 10-5 
S  8.2 10-6 
F  6 10-4  
S  6 10-5  
F  1.6 10-3 
S  0.8 10-3 
F  2.1 10-7 
S  1.0 10-8 
F  0.065 
S  0.0065 
F  3.5 10-5   
S  7 10-6 
F  4 10-4 
S  8 10-5 
F  0.10 
S  0.01 

If left blank means no standard proposed 

− 
−  TEQ means toxic equivalents 

Proposed  MAC-
QS water 
µg/l  

Proposed 
EQS 
µg/kg ww 

Biota 

PHS? 

F  36 
S  7.2 
F  2.7  
S  0.54 

F  0.12  
S  0.012  
F  0.04 
S  0.004  
0.016  
F  5.8 10-4 
S  5.8 10-5 
F  7 10-4  
S  7 10-5  
F  0.52 
S  0.052 
F  3 10-4 
S  3 10-5 
F  0.34 
S  0.034 

33 

9.1 

Sum of 
PCDD+PCDF+PCB-DL 
8.0 10-3 µg.kg-1 TEQ 

167 

6.7 10-3  

Yes 

Yes 

Yes 

Yes 

No 

No 

No 
No 

No 

Yes 

Yes 

No 

No 

No 

No 

EN 

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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 reduce 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 feasible) of highly contaminated "hotspots". For 
some substances, additional measures might still be possible in other policy areas, e.g. those 
dealing with diffuse or air emissions, but the persistence 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 unintended 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  timelines  due  to  natural  conditions,  or  that  the 
pollution  has  a  transboundary  origin.    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  WFD  for  their  overall  chemical  status  against  all  the  EQS  and 
therefore  a  bad  situation  for  some  chemicals  (in  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 identified in 2001 could be subject to more stringent EQS, it is 
likely  that  the  failure  rate  would  increase.  Theoretically,  given  that  the  possible  new  PS 
referred  to  here  are  ubiquitous  and  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. However, 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 the 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 Hexachlorobutadiene), for which EQS for biota 
are given in the EQSD45 that MS have to use unless they develop and apply a water standard 

45  

These  substances  are  hydrophobic  and  bioaccumulative  and  therefore  the  preferred  matrix  for 
monitoring is biota; their concentrations in water are so low that are rarely measurable using state of the 
art  analytical  techniques.  The  main  exposure  route  causing  risk  is  secondary  poisoning,  i.e.  risks  to 
human health via ingestion of contaminated fish or shellfish. 

EN 

73 

   EN 

 
                                                 
that  offers  the  same  level  of  protection  as  the  biota  standard  (hence  the  water  standards  in 
Annex I are never used for these three substances). 

Knowledge  and  methodologies  to  develop  EQS  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  EQS  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  States, the number of national or river basin standards set by 
Member States is very limited, demonstrating 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  sediment  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 almost 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  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  determination.  This  means  that  where  the  results  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  analytical  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  minimum  criteria,  the  best  available  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 able to monitor at the level of that EQS. The 
fact that PBTs tend to accumulate in sediment and biota means that their concentrations are 
likely to be higher in those matrices than in water. The analytical methods are therefore more 
likely to be adequate, and more likely to demonstrate 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 chemical 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 status. 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%.  Although  it  is  not  clear  whether  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  biota  has  reported  in  the  RBMPs  a 
failure rate based on a water standard of only 8.4%.  

Monitoring effort 

EN 

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An  additional  issue  that  has  been  raised  by  MS  in  relation  to  these  substances  is  the 
monitoring requirements. The WFD (Annex V) sets 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 the water bodies with a sufficient level of confidence and 

measuring the improvements resulting from the programmes of measures (operational 
monitoring (guideline) - monthly frequency 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 assessment 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 frequency would seem justified. A reduction in 
the number of monitoring sites might also be reasonable.  If MS choose to use a sediment or 
biota  standard,  the  default  monitoring  frequency  is  already  lower  (annually  rather  than 
monthly).  The issue is how, for ubiquitous PBTs, the monitoring frequency can be optimised 
to minimise the administrative burden while still yielding sufficient information. 

Knowledge base 

Emerging pollutants 

The  NORMAN  network46  defines  emerging  pollutants  as:  "pollutants  that  are  currently  not 
included  in  routine  monitoring  programmes  at  the  European  level  and  which  may  be 
candidates for future regulation, depending on research on their (eco)toxicity, potential health 
effects and public perception and on monitoring data regarding their occurrence in the various 
environmental  compartments". 
  In  addition,  there  are  many  unregulated  "emerging 
substances"  which  have  been  detected  in  the  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  pollutants  and  emerging  substances  numbers 
some 750 substances. 

Watch list technical details 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 ecotoxicological data) that they may pose a 
risk  to  or  via  the  aquatic  environment  at  EU  level,  but  for  which  there  are 
insufficient data or insufficiently high-quality data to assess the risk 

46  

The  NORMAN  network  started  its  activities  in  September  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 

75 

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•  Development of guidelines (substance-specific, if appropriate) on:  

−  selecting representative stations (250-300 across the EU) (to be selected by MS) 
−  sampling methods and/or periods  
− 
− 
− 
−  any other technical needs to deliver a high quality dataset.  

the monitoring matrix/matrices (water, 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  

Existing structures would be used for the technical work and for data collection. In particular, 
the technical work would be done using the existing informal structures of the WFD Common 
Implementation  Strategy  (CIS),  in  particular  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  represented  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  comparison. Data collection would be done using 
the Water Information System for Europe (WISE) managed by the EEA - an already a well-
established  EU  system  for  collecting  water  data.  Alternative  options  considered  (e.g. 
establishing  an  ad-hoc  system  for  reporting)  would  likely  be  more  expensive  and  less 
effective. 

The additional monitoring involved, which would be done by MS, would be limited. Current 
water-related  monitoring  requirements  are  already  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  (ecological  status),  other  Water  Directives  (Bathing  Water,  Nitrates, 
Urban Waste Water) and other water-related international commitments (OSPAR, HELCOM, 
Barcelona  Convention,  Rhine  Commission,  ICPDR,  etc).  The  proposal  for  the  watch  list  to 
have 20±5 substances monitored at 250-300 stations is considered reasonable noting that: 

−  For  each  substance  on  the  watch  list  a  minimum  of  information  would  need  to  be 
gathered  (available  monitoring  data,  ecotoxicological  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 significantly the administrative costs. 

−  There  is  a  pragmatic  limit  on  how  many  substances  can  be  considered  in  detail  for 
prioritisation  in  each  of  the  regular  reviews  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 substances renewed on 
average every two years would provide monitoring data on about 40 substances every 4 
years. This would provide substantial and probably sufficient input for the objective of 
the  regular  review  of  the  PS.,  especially  in  view  of  the  other  possible  sources  of 
information including the data on RBSPs. 

−  There are 110 RBDs in the EU, 176 if each national part is considered separately. The 
figure of 250-300 stations would provide for at least one station per RBD and more in 
the case of large RBDs. This would 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  results  subjected  to  expert  scrutiny.  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 

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conclusive after a year, the substance would be kept on the watch list. If the information were 
considered  sufficient  for  risk  assessment  purposes,  the  substance  would  be  replaced  by 
another. It is estimated that on average the substances would remain on the list for 2 years. 

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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) 

(ii) 

Determine whether additional substances should be identified as PS or PHS and if so, 
to establish the appropriate EQS for each substance in water, sediment and/or biota. 
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 matrix (i.e. water, sediment and/or biota), and 
the  determination  of  the  EQS,  are  largely  scientific/technical  decisions  that  take  account  of 
the  behaviour  of  a  particular  substance  in  the  environment  and  the  availability  of  relevant 
scientific information.   There are 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  Staff  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  allowed  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  (Entec,  2011b).  The  individual  substance  reports 
from  Entec  are  also  available  (Entec,  2011)  .  The  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  information.    In  this  approach,  a  number  of  case 
studies (generally two or three per substance) were 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 substance 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 applicability of the case study findings 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  undertaken  on  a  MS  where 
impacts were likely to be identified.   

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–  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  environmental  and  social  benefits  (cf  economic) 
was particularly limited.  Although it was possible to put a figure on some costs (e.g. for 
advanced UWWT) and benefits (e.g. for recreational 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  found  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 (starting 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  different  matrices  and  overall  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 dissolved), sediment and 
biota. The results were as follows (EU average): 

Unit costs 
Sample water 
Sample sediment 
Sample biota 
Analysis water 
Analysis sediment 
Analysis biota 

Euros 
128 
228 
422 
133 
128 
151 

Average of total and dissolved (112 and 145) 

Average of total and dissolved (105 and 162) 

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 analytical costs using these percentages resulted in 
the following unit costs: 

Sample weighted average 
Analysis weighted average 

137 Euros
133 Euros

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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.    Extrapolation  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  surveillance  monitoring  and  monthly  for  operational 
monitoring.  But  there  are  flexibilities  to  reduce  the  frequency  on  the  basis  of  technical 
knowledge  and  expert  judgement.  For  monitoring  in  biota  or  sediment,  the  minimum 
frequency is once per year (Article 3(2)c of EQSD); a reduced frequency is also possible on 
the basis of technical knowledge and expert judgement. Trend analysis 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,  industrial  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  total  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).  Still,  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 figures 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/environment/water/water-framework/implrep2007/pdf/sec_2009_415_2_en.pdf 
48  

Assumes the average frequency of monitoring of 2 samples per year. 

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Conclusions  

Feedback from MS confirms the robustness 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 monitoring. 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 adapted later on at the RBMP stage.  

–  Data  on  unit  costs  were  obtained  from  only  16  MS.    However,  they  covered  a  good 
geographical and socioeconomic range, 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 added to the watch list) are 
not the same as the existing PS. However, the types 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 average for all matrices) 128 

Unit costs analysis (weighted average for all matrices) 

133 

Overall costs of monitoring of existing PS 

Unit costs per PS based on overall monitoring 

69 

1.7 

- 

- 

41 

1 

- 

- 

97 

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 and the range in number of stations, substances 
and the average frequency of 2 samples per year, as presented in section 4.4.2: 

Million € 

15 substances 

25 substances 

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250 stations 

300 stations 

2.0 

2.4 

3.3 

4.0 

These  costs  are  calculated  considering  one  sample  per  analysis.  This  substantially 
overestimates the costs, as some of the substances 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 analytical costs that were 
reported  by  MS  refer  to  routine  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  higher  costs  per  analysis. 
Increasing the unit costs of analysis by 50% would result in an increased annual cost for the 
watch list of 25%, resulting in a total of 2.5 to 5 million € for the whole EU. 

It is estimated that the above sources of overestimation and underestimation would partially 
cancel each other out. The range of the cost estimate (2 to 4 million €) is considered robust, as 
confirmed by consultation with MS, and represents between 3 and 6% of the current average 
overall costs of monitoring of PS (69 million, average of the range 41-97 million €). 

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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  based  on  the  information  in  Entec  (2011)  and 
technical documents (EQS dossiers, source-screening and measures sheets) produced during 
the review process. 

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17-alpha-ethinylestradiol (EE2) factsheet 

Proposal: New priority substance 

Proposed critical EQS: AA-EQS freshwater,eco 

Rationale:  

Endocrine disruptive; risk ratio >1 

Main sources (production, use etc):  

Proposed status: PS 

Fresh 3.5 10-5  Salt 7 10-6 

Synthetic steroid most commonly used as the oestrogen component of combined oral contraceptives; 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  EQS  in  water  (see  "Uncertainties").  Emissions  may  be 
reduced due to improvement in  waste  water 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 success of take-back schemes generally lacking but also very variable. 

IMPACTS 

Costs: 

Some  potential  measures  identified  but  effectiveness  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, 
information  to  patients,  doctors  and  pharmacists  to  influence  prescription  and  achieve  partial  replacement  by 
alternative contraceptives, etc) would be expected to reduce consumption of EE2 over 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 producing 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 design 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 environmental concentrations below no-effect levels, in particular for fish, possible increase 
in  sustainability  of  fish  stocks  through  reduced  negative  impacts  on  fish  reproduction.  Benefits  for  wider 
biodiversity  related  to  increased  fish  stocks.  Potential  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 drinking  water, hence potential savings in drinking  water 
treatment. 

Special points:  

Sectors (most relevant): Fisheries, 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  database,  plus  literature).  Usefulness  of 
monitoring information also limited because limits of detection usually 2 orders of magnitude 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 environmental impact of pharmaceuticals in use.  

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17-beta-estradiol (E2) factsheet 

Proposal: New priority substance 

Proposed critical EQS: AA-EQS freshwater,eco 

Rationale:  

Endocrine disruptive; risk ratio >1 

Main sources (production, use etc):  

Proposed status: PS 

Fresh 4 10-4  Salt 8 10-5 

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. Emissions 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 Sustainable Use of Pesticides, 
through the implementation of buffer strips.  

IMPACTS 

Costs: 

Some potential measures have been identified but effectiveness very difficult to estimate. Measures should focus 
on  reducing  emission  due  to  human  and  livestock  excretion  (e.g.  improvements  to  UWWTPs  and  protection  of 
water  courses  from  livestock).  Emissions  from  pharmaceutical  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 control and, if entailed, would likely be passed through in 
full  or  in  part  to  consumers,  within  proportionate  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 CO2 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 environmental concentrations below no-effect levels, in particular for fish, possible increase 
in  sustainability  of  fish  stocks  through  reduced  negative  impacts  on  fish  reproduction.  Benefits  for  wider 
biodiversity  related  to  increased  fish  stocks.  Potential  economic  and  social  benefits  related  to  commercial 
fisheries  and  recreational  uses  (angling).  Increased  waste  water  treatment  will  reduce  discharge  of  many  other 
pollutants.  Lower  risk  of  endocrine-disrupting  substances  in  drinking  water,  hence  potential  savings  in  drinking 
water treatment. 

Special points:  

Sectors (most relevant): Fisheries, livestock 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 livestock that reaches surface  waters. Uncertainties about the 
effectiveness of the WFD measures included in the baseline 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).  

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Aclonifen factsheet 

Proposal: New priority substance 

Proposed status: PS 

Proposed critical EQS: AA-EQS freshwater,eco 

0.12 µg/l 

Proposed corresponding EQS in freshwater:  

Not relevant 

Rationale:  

Ranked high in modelling based prioritisation; bioaccumulative and toxic (and some evidence of persistence); risk 
ratio >1 

Main sources (production, 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  introduced  requirement  under 
Directive 91/414/EEC for buffer strips next to water courses. Likely to be aided by implementation of the Directive 
on Sustainable Use of Pesticides. 

IMPACTS 

Costs: 

Buffer strips already obligatory, but wider 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  authorisation  process.    Possible  additional  benefits  to 
biodiversity if measures improved. Reduced risk of failure of individual and total pesticides standards in drinking 
water. 

Special points:  

Note: Many benefits expected to be achieved under the baseline, but could be accelerated if improved knowledge 
of  concentrations  leads  to  better  management,  e.g.  wider  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 substance 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. 

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Anthracene factsheet 

Proposal: More stringent MAC for existing substance. 

Proposed  status:  Unchanged  (PHS  due  to  PBT 
properties) 

Proposed critical EQS: QS freshwater, eco  

Unchanged 

Proposed corresponding EQS in freshwater:  

Not relevant 

Proposed MAC:  

Rationale: 

0.1 μg/l (cf 0.4 μg/l) 

Review of the QSs prompted by revised RAR for pitch.  Conclusion that high acute toxicity justifies setting MAC 
equal to AA-EQS. 

Main sources (production, use etc):  

Aromatic hydrocarbon.  Occurs naturally in fossil fuels/derivatives and is produced during combustion; is therefore 
emitted from many industrial processes using fossil fuels or involving combustion. Pure anthracene (approx 1000 
tonnes  per  annum  in  EU)  manufactured  from  coal  tar  pitch  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 agents for e.g. electrodes, road construction, roofing. 

Total emissions highest from coke production, aluminium production, creosote and wood preservation (restricted 
conditions  since  2003),  domestic  fuel  combustion,  vehicle  engines,  tyres  (production  and  use),  agricultural 
burning and forest fires, though half-life in air short, therefore atmospheric deposition relatively low cf some other 
PAHs,  though  still  significant.  Emissions  to  water  (approx  9  tonnes  in  E-PRTR  2008)  highest  from  metals 
production. 

BASELINE 

4  MS  report  current  failure  of  existing  AA-EQS.  Monitoring  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 Directive/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 local improvements in water quality and ecosystem health. 

Special points:  

Note: Although accumulation in biota is relevant (secondary poisoning), critical EQS remains direct toxicity. 

Sectors (most relevant): Coal tar distillation; 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. 

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Bifenox factsheet 

Proposal: New priority substance 

Proposed status: PS 

Proposed critical EQS: AA-EQS freshwater,eco 

1.25 10-2 µg/l 

Proposed corresponding EQS in freshwater:  

Not relevant 

Rationale:  

Ranked high in modelling based prioritisation, very toxic, risk ratio >1 

Main sources (production, 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  additional  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  authorisation  process.    Possible  additional  benefits  to 
biodiversity. Reduced risk of failure of individual and total pesticides standards in drinking water. 

Special points:  

Note: Many benefits expected to be achieved under the baseline, but could be accelerated if improved knowledge 
of  concentrations  leads  to  better  management,  e.g.  (wider)  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  recent  adoption  of  the  Directive  on  the  Sustainable  Use  of  Pesticides.  
Uncertainty regarding peak concentrations following application. 

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Cybutryne factsheet 

Proposal: New priority substance 

Proposed status: PS 

Proposed critical EQS: AA-EQS freshwater,eco 

0.0025 µg/l 

Proposed corresponding EQS in freshwater:  

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 (production, use etc):  

Biocidal (algicidal) use - approx 10 tonnes/yr in EU (incomplete data) - especially as antifouling agent in coatings 
for boat hulls (commercial, recreational) and on marine equipment/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 literature confirm potential for exceedance. Some national bans on use for small 
vessels  have  recently  come  into  force.  Uses  as  antifouling  agent  and  film/masonry  preservative  currently  being 
reviewed under the Biocidal Products Directive 98/8/EC; outcome could affect baseline. 

IMPACTS 

Costs: 

Any  additional  material  costs 
frequent  mechanical 
cleaning/maintenance. Increased shipping fuel costs/CO2 etc emissions if alternatives less effective.  Costs might 
be passed on to consumers/passengers.  

  Labour  costs 

for  substitutes. 

if  use  more 

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.  Stimulation  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 baseline, but not all MS have national bans in place and only 
small vessels are covered. 

Sectors (most relevant): Coatings, Construction, Fisheries, 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. 

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Cypermethrin factsheet 

Proposal: New priority substance 

Proposed status: PS 

Proposed critical EQS: AA-EQS freshwater,eco 

8.2 10-5 µg/l 

Proposed corresponding EQS in freshwater:  

Not relevant 

Rationale:  

Ranked very high in monitoring-based prioritisation and high in modelling-based prioritisation; very toxic; risk ratio 
>1 

Main sources (production, 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 chemical treatments to cope with resistance development. 

IMPACTS 

Costs: 

Costs  to  arable  farmers  of  implementing  buffer  zones.  Costs  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  salmon  farmers  of  using  management  measures  to  ensure 
compliance with EQS. In Scotland, a quality standard was 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  alternative  treatment  using  hydrogen  peroxide  (less  harmful  to  environment) 
already being developed. Additional material costs for substitutes, if relevant. In horticulture and cereal cropping, 
alternatives  generally  available,  plus  possibility  of  controlling  certain  pests  by  irrigation  management.  Loss  of 
cypermethrin (though not foreseen in the options) would have only a minor impact, except in the context of vine 
weevil control, where in the UK at least there could be some costs (ADAS 2010, HGCA 2009). 

Admin costs: Monitoring costs for MS.   

Benefits:  

Better knowledge of water quality; feedback to the PPP and biocidal products authorisation 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): Aquaculture, Agriculture, Pesticides (Biocides, Plant Protection Products). 

Geographical impacts:  Formulations manufactured by 5 companies 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 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 
(ES, FR, IT, RO have high numbers of sheep). Likely trend in use in agriculture and forestry. Outcome of Biocidal 
Products Directive review.   

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DEHP factsheet 

Proposal: New status for existing substance 

Proposed status: PHS 

Proposed critical EQS: Unchanged  

As in existing EQS Directive 

Proposed corresponding EQS in freshwater:  

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  children  in  relation  to  exposure  via  the  environment  (taking 
account of existing risk reduction measures). 

Main sources (production, use etc):  

Industrial  chemical,  used  as  plasticiser  in  polymers,  mainly  in  flexible  PVC  (for  roofing,  piping,  tubing,  flooring, 
furniture, clothing etc) and, to a limited extent in some non-polymer products.  Emissions to environment during 
production,  formulation,  use  and  disposal  –  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,  especially  from  outdoor  polymer  use  to  soil  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 use, 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  emissions  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  flexible  PVC  (approx  800  in  EU),  including  impacts  on 
employment (though could shift to alternative substances/products), 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  water  run-off,  landfill  leachate)  including  cost  of  SUDs  and  energy  costs,  CO2 
emissions. To cease all emissions, replacement of many PVC fixtures/fittings/products; costs of correct disposal. 
However,  such  water  treatment  or  product  replacement  before  natural  "end-of-life"  would  be  subject  to 
assessment of costs, including environmental costs, and exemptions on the basis of disproportionate costs and 
non-feasibility could be applied. 

Admin  costs:  Possibly  remediation  costs  (MS  and/or  industry).  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, plastics/polymers, textiles, water/sewerage. 

Geographical impacts: Production in fewer than 10 MS (possibly 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, 

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separate  consideration  being  given  to  banning  use  in  electrical  equipment  and  PVC  –  outcome  not  certain. 
Impacts on import. 

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Dichlorvos factsheet 

Proposal: New priority substance 

Proposed status: PS 

Proposed critical EQS: AA-QS freshwater, eco 

6 10-4 µg/l 

Proposed corresponding EQS in freshwater:  

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 (production, 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  consumption  decreases,  e.g.  if 
certain product types no longer authorised (though impacts most likely in baseline). 

Admin costs: Monitoring costs for MS. 

Benefits:  

Better knowledge of water quality; potential for better water quality and ecosystem health; 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  (producer)  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 absence of sufficiently sensitive analytical method. Outcome of 
Biocidal Products Directive review. 

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Diclofenac factsheet 

Proposal: New priority substance 

Proposed status: PS 

Proposed critical EQS: AA-EQS freshwater,eco 

0.1 µg/l (freshwater), 0.01 µg/l (saltwater) 

Proposed: MAC-EQS freshwater,eco  

75 µg/l (freshwater), 7.5 µg/l (saltwater) 

Rationale:  

Toxic; risk ratio >1 

Main sources (production, 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 analgesic 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 effectiveness 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  companies  producing  diclofenac  due  to  reduced  sales,  unless 
they can move into the market for alternatives. 

Admin costs: Monitoring costs for MS. Depending on the design 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 higher 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.  

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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 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.   

Main sources (production, use etc):  

Possibly residual (non-authorised)  use  as PPP, predominantly 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 necessary, 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 producers already in baseline (assuming not manufactured 
in EU only for export). Dicofol was authorised in 11 MS, many of which withdrew authorisation 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 absence of sufficiently sensitive analytical method. Extent of 
failure of EQS following exclusion from Annex I of Directive 91/414/EEC. 

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Dioxins and Dioxin-like-PCBs factsheet 

Proposal: New priority substance 

Proposed status: PHS 

Proposed critical EQS: QS biota, sec pois   

8 10-3 µg TEQ/kg biota wwNone calculated. 

Proposed corresponding EQS in freshwater:  

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 (production, 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  industrial  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, textile washing/bleaching. 

PCBs  are  chlorinated  organic  compounds  formerly  produced  and  used  in  EU  in  manufacturing  electrical  and 
hydraulic  equipment  and  lubricants  etc;  12  congeners  are  dioxin-like.  Combustion  of  waste  may  produce  some 
DL-PCBs.  Atmospheric  deposition  occurs.  Most  direct  emissions  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  landfills  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 decreased 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 the disposal of PBC-containing waste and restrictions on 
transboundary movements of hazardous waste. PCBs banned for use in open applications since 1976 (Directive 
76/403/EEC)  and  closed  applications  since  1985  (Directive  85/467/EEC),  though  remain  in  flooring,  sealants, 
paints etc.  Food standards exist. 

IMPACTS 

Costs: 

Most  costs  in  baseline.  Possibly  additional  water-treatment  costs,  including  energy/CO2  emissions.  Possibly 
accelerated  measures  to  reduce  the  likelihood  of  dioxins  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  water  quality;  avoidance  of  environmental  accumulation  (by 
accelerated  measures);  remediation  if  necessary;  potential  for  better  water  quality  and  better  biota  and  human 
health; potential for better aquaculture/fisheries/angling; improved consumer confidence (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  technologies.  Possible  employment  in 
remediation work.   

Special points:  

Note: Most costs and benefits expected to be realised 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. 

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Fluoranthene factsheet 

Proposal:  Biota  EQS  as  critical  EQS.    Corresponding 
water  EQS  much  more  stringent  than  existing  EQS.  
MAC also more stringent. 

Proposed critical EQS: QS biota, hh  

Proposed corresponding EQS in freshwater:  

Proposed MAC:  

Rationale: 

Review of the QSs prompted by revised RAR for pitch. 

Main sources (production, use etc):  

Proposed status: Unchanged (PS) 

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) 

Aromatic hydrocarbon.  Occurs naturally in fossil fuels/derivatives and is produced during combustion; is therefore 
emitted from industrial processes using fossil fuels or involving 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  energy  sector  (mainly  from 
refining and combustion) and  metals production (particularly aluminium, though 2009 emissions from  one major 
contributor are much lower). Other emissions to water from 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  proposed  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;  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. 

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  biota  monitoring).  Improvement  in  water  quality;  decreased 
scope for accumulation in the environment (fluoranthene binds to particles), potential for better biota health and 
better  aquaculture/fisheries/angling  (including  reduced  wastage);  potential  for  better  human  health  (though 
carcinogenicity not confirmed). 

Special points:  

Sectors (most relevant): Chemicals, energy, metals production. 

Geographical  impacts:    Relevant  industries  (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 some MS.inclusion or not in REACH Annex XIV 

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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 (production, use etc):  

Industrial  chemical,  used  as  flame  retardant  in  polymers:  insulation  boards  (Expanded  PolyStyrene,  eXtruded 
PolyStyrene), electronic equipment (High Impact PolyStyrene), textile coatings (for furniture 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  biota  EQS.  REACH  Annex  XIV  authorisation  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  likely  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. Enhanced  waste water treatment costs and 
CO2  emissions.    In  the  absence  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 formulators, 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, possibly remediation costs (MS and/or industry). 

Benefits:  

Mostly  in  baseline.  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 confidence (though could be lower confidence in the 
short  term);  potential  for  better  human  health;  stimulation  of  innovation;  benefits  to  producers  of  alternatives 
including potential employment; employment in remediation work. 

Special points:  

Note: PHS designation consistent with approach under REACH. Most costs and benefits expected to be realised 
under the baseline – dependent upon REACH Annex XIV authorisations; could 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 fire regulations.  Benefits likely beyond the EU. 

Uncertainties: 

Possible  authorised  uses  under  Annex  XIV  of  REACH;  timeline  for  availability  of  alternatives  (none  yet  for 
EPS/XPS,  though  in  pipeline);  environmental  and  health  impacts  of  chosen  alternatives;  impacts  of  waste 
disposal route (incineration cf landfill). 

EN 

98 

   EN 

 
 
Heptachlor factsheet 

Proposal: New priority substance 

Proposed critical EQS: QS biota, hh 

Proposed corresponding EQS in freshwater:  

Rationale:  

Proposed status: PHS 

6.7 10-3 µg/kg biota ww 
2.1 10-7 µg/l 

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. 

Main sources (production, use etc):  

Organochlorine insecticide.  Possibly (unlikely) residual (non-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/CO2 emissions. 

Admin costs: Monitoring costs for MS.  Possibly sediment remediation costs. 

Benefits:  

Better knowledge of water quality; remediation if necessary, 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  already  in  baseline;  could  be  higher  remediation  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 

99 

   EN 

 
 
 
Lead factsheet 

Proposal:  Revised  EQS 
bioavailability, for existing substance, 

taking 

account 

of 

Proposed status: Unchanged (PS) 

Proposed critical EQS: QS freshwater, eco  

1.2(fresh), 1.3(salt) (bioavailable) µg/l (cf 7.2 µg/l) 

Proposed corresponding EQS in freshwater:  

Not applicable 

Proposed MAC: 

Rationale: 

14.25 µg/l 

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 (production, use etc):  

Production approx 1.5 million tonnes per annum in EU, consumption slightly higher, value approx 3 billion Euros.  
At least 8 primary (from ore) production sites in at least 5 MS, approx 30 secondary (recycling) production sites in 
at  least  12  MS.  Production  associated  with  mining/extraction  of  other  metals,  especially  zinc.  Main  uses:  in 
batteries/accumulators,  also  in  shot,  boat  keels,  weights,  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, waste disposal including landfill and incineration. Also from 
diffuse sources: hunting/fishing, road run-off (tyres, vehicle exhausts), roof run-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 emissions 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;  compliance  likely  to  be  similar  (i.e.  at  approx  6  cf  7.2  µg/l  total 
lead),  though  could  be  poorer  where  dissolved  organic  carbon  (DOC)  low.      Subject  to  control  under  several 
Directives and Regulations, including REACH, IPPC/IED, Drinking Water Directive, Groundwater Directive, WEEE 
Directive, Batteries Directive.  

IMPACTS 

Costs: 

Mostly  in  baseline.  Possible  increase  in  need  for  control  measures  (e.g.  SUDs  for  run-off)  and/or  remediation 
at/near historic mining sites and/or other contaminated 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  health  (lead  is  bioaccumulative  and  toxic);  potential  for 
improved  aquaculture/fishing;  potential  for  better  human  health/IQ;  employment  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): Construction, mining, energy, sewerage/water. 

Geographical impacts:  Possibly  greater costs in MS reporting failure of existing EQS. Possibly greater costs in 
MS  with  high  number  of  facilities  reporting  high  total  emissions  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  variation  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 

100 

   EN 

 
 
Effectiveness of existing and possible additional measures at contributing to meeting the EQS. 

EN 

101 

   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  

2.0 μg/l (cf 2.4 μg/l) (same for marine cf 1.2) 

Proposed corresponding EQS in freshwater:  

Not relevant 

Proposed MAC:  

Rationale: 

130 μg/l (cf none) 

Review of the QSs prompted by revised RAR for pitch. 

Main sources (production, use etc):  

Aromatic hydrocarbon.  Occurs naturally 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,  grinding  wheels  and  pyrotechnics.  Approx  25%  exported.  
Also present in creosote, tar paints etc..  

Reported emissions to air and water (approx 192 and 190 tonnes respectively in E-PRTR 2008) highest from the 
energy  sector  (especially  to  water,  mainly  from  oil  drilling/refining)  and  metals  (including  aluminium)  production. 
Other  emissions  to  water  from  wood  treatment  with  creosote  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 MAC. EU RAR calculates PECs that could locally exceed 
AA-EQS  or  MACs  close  to  industrial  point  sources.  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; Directive 98/8/EC – restrictions 
on  biocidal  use;  Directive  91/414/EEC  excludes  naphthalene-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 exceedance of proposed MAC. 

Possibly additional measures directed at (industrial) 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 local improvements in water quality and ecosystem health. 

Special points:  

Sectors (most relevant): Chemicals, 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 some MS. Inclusion or not in REACH Annex XIV 

EN 

102 

   EN 

 
 
 
Nickel factsheet  

Proposal:  Revised  EQS 
bioavailability, for existing substance, 

taking 

account 

of 

Proposed status: Unchanged (PS) 

Proposed critical EQS: QS freshwater, eco  

2 or 4 (fresh), 8.6 (salt) (bioavailable) µg/l  (cf 20 µg/l) 

Proposed corresponding EQS in freshwater:  

Not applicable 

Proposed MAC: 

Rationale: 

34 µg/l 

New  information  (EU  RAR  2008,  SCHER  review  of  RAR  2009,  additional  industry  studies  related  to  REACH 
registration), and need to consider bioavailability. 

Main sources (production, 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, also in metal plating, batteries, pigments, other chemicals, 
steel  production  (especially  stainless).    Products  (wide  range,  e.g.  vehicles,  domestic  appliances  and  fittings, 
chemical plants, medical equipment) valued 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  processes),  steel  products  in  contact  with  water  (including 
heating elements), waste disposal, mining.  Significant flow through UWWTPs. Emissions to air (350 tonnes in E-
PRTR for 2008) from combustion, some of which reaches water by atmospheric deposition (directly and via soil). 
Inputs  also  from  manure  use  in  agriculture.  Some  diffuse  sources,  e.g.  urban  road  run-off,  pass  through 
UWWTPs. 

BASELINE 

9 MS report failure of current EQS in up to 3.7% of rivers. EQS (bioavailable) of 2 µg/l or 4 µg/l effectively more 
stringent  than  existing  (i.e.  at  approx  5.6  or  11.2  cf  20  µg/l  total  dissolved  Nickel,  assuming  standard  dissolved 
organic  carbon  (DOC),  pH  and  hardness),  therefore  failures  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 probably not sufficient to achieve revised EQS..  

IMPACTS 

Costs: 

Possible  increase  in  need  for  control  measures  to  reduce  industrial  Nickel  emissions  to  UWWTPs  especially 
where  DOC  levels  are  low  (e.g.  improved  BAT;  precipitation/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 90,000-180,000 €, 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-sulphur  fuels,  desulphurisation  -  £100-1000  million/tonne 
decrease), lime dosing of abandoned mines (£3.5 million 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 better water quality and ecosystem health (nickel is toxic and 
can accumulate in soils/sediments), therefore potential for improved aquaculture/fishing. Focus on bioavailability 
likely  to  lead  to  better  monitoring  information,  therefore  also  better  targeting  of  control  measures/remediation.  
Benefits to human health mainly if measures lead to decreased atmospheric emissions. 

Special points:  

Sectors (most relevant): Chemicals, domestic appliances, metal alloys, mining, energy, sewerage/water. 

Geographical impacts:  Possibly  greater costs in MS reporting 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 extent of variation in DOC, pH (thus bioavailability of nickel) across the EU.  
Effectiveness of existing and possible additional measures at contributing to meeting the EQS. 

EN 

103 

   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 critical EQS: QS biota, hh  

Proposed corresponding EQS in freshwater:  

Proposed MAC:  

Rationale: 

Review of the QSs prompted by revised RAR for pitch. 

Main sources (production, use etc):  

Proposed status: Unchanged (PHS) 

2  or  5  or  10  μg/kg  biota  ww  (fish,  crustaceans  & 
fresh  and 
in 
cephalopods,  molluscs,  respectively, 
marine water); Benzo(a)pyrene as marker. 
1.7 10-4 ug/l 

Aromatic hydrocarbon.  Occurs naturally in fossil fuels/derivatives and is produced during combustion; is therefore 
emitted from industrial processes using fossil fuels or involving 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  refining  and  combustion).  Other  emissions  to  water  from 
production  of  basic  organic  chemicals,  animal  and  vegetable  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.  Calculated  PECs  in  EU-RAR  indicate  that  concentrations 
could be higher than proposed 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;  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 shift to biota standards. Possibly remediation costs (MS 
and/or industry). 

Benefits:  

Better  knowledge  of  water  quality  (due  to  switch  to  biota  monitoring).  Improvement  in  water  quality;  decreased 
scope  for  accumulation  in  the  environment  (binds  to  particles),  potential  for  better  biota  health  and  better 
aquaculture/fisheries/angling  (including  reduced  wastage);  potential  for  better  human  health  (most  PAHs  are 
carcinogenic), though existing food standards should already be met and protective. 

Special points:  

Sectors (most relevant): Chemicals, energy, metals production. 

Geographical  impacts:    Relevant  industries  (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 some MS. Inclusion or not in REACH Annex XIV 

EN 

104 

   EN 

 
 
 
PBDE factsheet 

Proposal:  Biota  EQS  (and  correspondingly  more 
stringent  water  EQS)  for  existing  substance,  intended 
to cover additionally commercial 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 cover 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 (production, 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-equipment-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  products,  including  furniture,  upholstery,  carpets,  drapery, 
computers, televisions, automotive parts (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 hepta derivatives since 2010. Deca BDE banned in electrical and electronic 
equipment since 2008 (Directive 2002/96/EC); other uses continue; not produced in EU, but imported (60k tonnes 
produced  worldwide  in  2007).  Alternatives  exist.  Disposal  controlled  by  WEEE  directive.  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 CO2 emissions to meet lower EQS. 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. Possibly 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 aquaculture/fisheries/angling; improved consumer confidence; 
potential  for  better  human  health;  employment  in  remediation  work.  Biota  monitoring  could  improve  quality  of 
monitoring information, therefore also the targeting of remediation. 

Special points:  

Note: PHS designation  of penta BDE (technical/commercial mixture) consistent  with approach  under Stockholm 
convention. Most costs and benefits expected to be realised under the baseline. 

Sectors (most relevant): Textiles, sewerage/water. 

Geographical  impacts:    Possible  impacts  on  producers  outside  EU  if  need  to  meet  lower  EQS  for  lower 
brominated congeners leads to restrictions on use of deca BDE. Benefits likely beyond the EU. 

Uncertainties: 

Extent of failure of EQS in MS due to inadequate analytical sensitivity. 

EN 

105 

   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 (production, use etc):  

Industrial chemical, not produced in EU.  Used in fire-fighting foams (residual use due to end 2011), coatings in 
photography  and  photolithography  (semi-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,  gradual  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 enhanced waste water treatment costs and CO2 emissions.  Possible earlier 
development costs for alternatives in photography, photolithography, aviation. In the absence of alternatives, cost 
of phasing out emissions to water could be disproportionate. 

Admin costs: Monitoring costs for MS, possibly 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  confidence;  potential  for  better  human  health  (workers, 
consumers); stimulation of innovation; potential 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 failure of EQS; timeline for availability of alternatives. 

EN 

106 

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Quinoxyfen factsheet 

Proposal: New priority substance 

Proposed status: PHS 

Proposed critical EQS: QS freshwater, eco 

0.15 µg/l 

Proposed corresponding EQS in freshwater:  

- 

Rationale:  

Annex III substance; PBT properties. 

Main sources (production, use etc):  

Use as PPP (fungicide), predominantly on cereals and grape vines, thence losses to water by way of spray-drift, 
run-off, spills. Otherwise secondary release, e.g. by leaching, from contaminated soils and sediments. EU sales 
68 000 kg/yr. 

BASELINE 

Limited  monitoring  data  (2  MS)  shows  isolated  exceedance  of  EQS  in  FR,  but  authorised  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  Directive;  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  formulators/retailers  unless  can  provide  substitute  products.  
Costs  to  users  if  substitutes  more  expensive.    Possible  concern  regarding  resistance  of  powdery  mildew  to 
alternatives, although several alternatives are authorised (Entec 2011, ADAS 2010, HGCA 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  better  water  quality  and  biodiversity,  better  biota  and  human 
health, aquaculture/fisheries/angling. 

Special points:  

Sectors (most relevant): Agrochemicals, 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/marketers in FR, 3 in UK. (case-study MS); no data for other MS. 

Uncertainties: 

Extent of failure of proposed EQS in several MS in absence of widespread monitoring.  Possibility of decrease in 
use under baseline because of resistance. 

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Terbutryn factsheet 

Proposal: New priority substance 

Proposed status: PS 

Proposed critical EQS: AA-EQS freshwater,eco 

0.065 µg/l 

Proposed corresponding EQS in freshwater:  

Not relevant 

Rationale:  

Ranked high in modelling based prioritisation, medium in monitoring-based prioritisation, toxic, risk ratio >1 

Main sources (production, 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 EQS in 4 MS and CH. Losses to water could be lower in 
coming  years  because  no  longer  in  Annex  I  of  Directive  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 Directive 98/8/EC; outcome could affect baseline. 

IMPACTS 

Costs: 

Installation  and  maintenance  of  sustainable  urban  drainage  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 biocidal products authorisation process.  Possible benefits to 
biodiversity, and to angling. Reduced risk of failure of drinking water standards. SUDs could have shared benefits, 
e.g. flood control, energy saving.  Stimulation of innovation in construction to minimise need for biocidal coatings. 

Special points:  

Note: Some benefits expected to be achieved under the baseline, but not all MS have SUDs in place to capture 
run-off in urban areas, and this could lead to improvements, 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 used as herbicide.  Availability of substitutes. 

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Trifluralin factsheet 

Proposal: New status for existing substance 

Proposed status: PHS 

Proposed critical EQS: Unchanged  

As in existing EQS Directive 

Proposed corresponding EQS in freshwater:  

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 stringent than for POP, i.e. 
120d cf 180d in soil). 

Main sources (production, 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 recovery/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 secondary 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 from use expected at present 
(authorisation under Directive 91/414/EEC withdrawn in 2009). Any emissions from production in HU would have 
to cease if POP designation agreed.  Possibly secondary emissions from disturbed sediments. 

IMPACTS 

Costs: 

Possible  cost  to  producer  in  HU  if  production  for  export  had  to  cease,  with  possible  loss  of  jobs  unless 
redeployment possible – though these costs would be in baseline if designated as POP. 

Admin costs: Possibly remediation costs (MS and/or landowners). 

Benefits:  

Remediation if necessary, with potential for better water 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. 

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ANNEX VI: Description of the main policies affecting the baseline and interactions with 
the WFD 

Implementation of the WFD: measures in river basin management plans (RBMPs) 

The  13  existing  substances  that  have  been  assessed  are  already  included  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  been  identified  and  their  implementation  be 
underway or planned where failures of the EQS occur.  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  extent  to  which  MS  intend  to  undertake  measures,  the  detail  of  those 
measures, and their likely effectiveness. 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 report. Another 3 are expected to adopt them in 
2011. The remaining 4 are expected to have longer delays.  

Once the plans and programmes are adopted, the 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  uncertainty  stems  from  a 
number  of  generic  measures  that  are  included  in  the  programmes  of  measures  that  aim  to 
improve  water  quality  and/or  reduce  concentrations  of  certain  types  of  pollutants  in  the 
environment.  These are relevant to both existing and proposed substances.  For example, the 
study by EcoLogic and ACTeon (2010) which reviewed agricultural measures in WFD draft 
programmes  across  Europe  identifies  some  of  these  measures.    This  provided  information 
relevant to proposed substances including general information on PPP policies and trends, and 
information on diffuse nutrient pollution that could contribute towards addressing substances 
such as 17 beta-estradiol (e.g. measures to reduce nutrient input to rivers, such as preventing 
cattle reaching river banks).   

There are also a range of measures to address water 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.  including  the  existing  and  proposed  substances 
assessed here).  Such measures include: 

•  Improved wastewater treatment; 

•  Addressing  urban  runoff  (both  water  quality  and  flood  risk)  through  use  of 

Sustainable Urban Drainage Systems (SUDS); 

•  Measures to address morphology pressure, including improving riparian habitats; 

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•  Measures to address rural diffuse pollution (particularly reductions in nitrogen and 
phosphorus  inputs),  for  example  by  controls  on  manure  spreading,  preventing 
cattle reaching river banks, general PPP measures. 

While not necessarily targeted at particular existing or proposed substances, over time these 
measures  have  the  potential  to  contribute  towards  achieving  the  EQSs  of  a  range  of 
substances. 

Some  of  the  proposed  substances  are  explicitly  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 failures 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/PHS,  potentially  with  a  more  stringent  EQS.  
Information  collected  from  WG  E  representatives  to  the  Commission  (note  that  not  all  MS 
provided information) indicates that 10 of the 15 proposed substances are already included as 
specific pollutants in at least one MS.  Heptachlor, PCBs, and Dioxins are the most commonly 
monitored, probably as a result of obligations under the Stockholm Convention. 

Substance 

MS including the substance as specific pollutant 

Number of MS 

Aclonifen 

Cybutryne 

SE (0.2 µg/l; 0.1 mg/kg sediment) 

SE (0.003 µg/l in marine water; 0.0002-0.0008 mg/kg dw) 

Cypermethrin 

DK (1 µg/kg in river or lake sediment)   

UK (0.1 ng/l annual mean; 0.4 ng/l 95th percentile) 

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) 

Dioxins (and DL-PCBs) 

DK (between 0.00005-0.0001 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) 

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) 

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) 

PFOS 

DK (0.2 µg/kg WW marine fish)  

CZ 25 µg/l  

Terbutryn 

CZ (0.1 µg/l), BG (0.01 µg/l) 

SE (30 µg/l in freshwater; 3 µg/l in marine water; 0.006 mg/kg biota) 

1 

1 

2 

5 

4 

2 

8 

3 

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 emissions of existing and proposed PS, and ultimately 
in reducing their presence in the environment.  

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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  (regarding  placement  of  PPPs  on  the  market).  
Individual active substances can be added to Annex I by individual directives which, in some 
cases, include requirements or restrictions on use 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 active substances at EU level.  

Directive  2009/128/EC,  establishing  a  framework  for  community  action  to  achieve  the 
sustainable  use  of  pesticides,  will  be  implemented  from  2011.    The  directive  includes 
measures to: 

•  Include instructions on safety, storage and disposal of pesticides with sales; 

•  Improve public awareness of possible risks from the use of pesticides; 

•  Promote research programmes aimed at determining 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  spraying  (from  a  plane  or  helicopter)  of 

pesticides (although derogations 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 eliminating use in areas with a high likelihood 
of runoff of surface water or sewers (e.g. roads and railways); 

•  Promote  low-pesticide  pest  management  methods  (including  integrated  pest 

management and organic farming); 

•  Minimising  or  prohibiting  use  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 the exact measures that will be put into place, 
but the directive clearly has the potential to reduce concentrations 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  policy  options  and  that  are  concerned  by  the  PPP 
legislation  are  Trifluralin,  Dicofol,  Quinoxyfen,  Aclonifen,  Bifenox,  Cypermethrin, 
Dichlorvos, Heptachlor and Terbutryn. 

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Biocides 

Directive 98/8/EC on the placing on the market of biocidal products aims to: 

•  Harmonise the European market for biocidal products and their active substances; 

•  Provide  a  high  level  of  protection  for  people,  animals  and  the  environment 

through risk assessment; 

•  Ensure products are sufficiently effective 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  approval  for  placing  on  Annex  I,  is  still  ongoing.  
The  review  covers  23  different  product  types  including,  for  example,  disinfectants, 
preservation  products,  non-agricultural  pesticides,  and  anti-fouling  products.    It  does  not 
include PPPs, which are covered under Directive 91/414/EEC. 

A  Commission  proposal  (COM(2009)  267)  to  replace  Directive  98/8/EC  is  currently  under 
negotiation.  The regulation aims to improve the functioning of the internal market in biocidal 
products while maintaining the high level of the environmental and human health protection.  
As  under  Directive  98/8/EC  there  would  be  a  two-tiered  authorisation  process:  inclusion  of 
the active substance in Annex I, followed by authorisation of the biocidal product. 

The substances that are included in the policy options and that are concerned by the biocides 
legislation are Cybutryne, Cypermethrin, 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  geographically,  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  reduce  the  release  of  POPs  into  the  environment.  
There were twelve original POPs, including pesticides, 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 exemptions listed in the Annex; 

•  Annex  C  (unintentional  production):  parties  must  take  measures  to  reduce  the 
unintentional  releases  of  chemicals  listed  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  legislation  on  POPs  and  aligns  it  with  the 
provisions  of  the  international  agreement.    The  regulation  contains  provisions  regarding 

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production,  placing  on  the  market  and  use  of  chemicals,  management  of  stockpiles  and 
wastes, and measures to reduce unintentional releases of POPs. Furthermore, MS must set up 
emission  inventories  for  unintentionally  produced  POPs,  national  implementation  plans 
(NIPs) and monitoring and information exchange mechanisms. 

The WFD mechanism can ensure monitoring of these 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  Conventions  “there  is  a  general  lack  of 
coordinated  monitoring  or  regional  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  deals  with  the  Registration,  Evaluation,  Authorisation  and 
Restriction of Chemical Substances (REACH). It entered into force in June 2007.  The aim of 
REACH is to improve the protection of human health and the environment through the better 
and  earlier  identification  of  the  intrinsic  properties  of  chemical  substances.    The  regulation 
required  manufacturers  and  importers  to  gather  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 importers 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 management measures. Substances not 
included  include  those  that  are  regulated  elsewhere  (e.g.  PPPs,  biocides  and 
medicinal  products),  those  present  at  very  low  risk,  or  those  occurring  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 (inclusion in Annex XIV).  For these substances 
to  continue  to  be  used,  applicants  will  have  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 alternative 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-GMP-RMR-WEOG.English.PDF 
and  UN-ECE  Convention  on  Long-Range  Transboundary  Air  Pollution.  Working  Group  on  Effects. 
transboundary  air  pollution. 
POPs 
EB.AIR/WG.1/2005/6 
(2005). 
http://www.unece.org/env/documents/2005/eb/wg1/EB.AIR.WG.1.2005.6.e.pdf   

the  Freshwater  environment:  Effects  of 

long-range 

in 

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•  Restrictions  can  be  placed  on  the  manufacture,  marketing  or  use  of  particular 

substances. 

DEHP  and  HBCDD  have  been  added  to  REACH  Annex  XIV  for  authorisation  (February 
2011).  

Other  substances  included  in  this  assessment  are  being  considered  for  authorisation.    This 
includes Anthracene (and related oils, pastes) and 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  substantially.  In  any  case  the  WFD  will  monitor  the 
concentrations of these substances in the aquatic environment and, in the case of PAHs and 
Anthracene, progress towards the cessation/phase-out objective. 

The substances that are included in the policy 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  (Directive  2010/75/EC)  recasts  seven  existing 
Directives relating to industrial emissions into a single coherent legislative instrument.  The 
recast  covers  the  Integrated  Pollution  Prevention  Control  (IPPC)  Directive,  the  Large 
Combustion  Plants  Directive,  the  Waste  Incineration  Directive,  the  Solvents  Emissions 
Directive,  and  three  Directives  on  Titanium  Dioxide.    The  directive  has  been  developed  to: 
improve  implementation  of  BAT;  reduce  limitations  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  Available  Techniques  (BAT).    Emission  limits  and 
operating  conditions  contained  in  the  IPPC  authorisation  permits  are  based  on  BAT,  taking 
into  account  the  technical  characteristics  of  an  installation,  its  geographic  location  and  the 
local  environmental  conditions.    BAT  reference  documents  (BREFs)  are  produced  by  the 
European IPPC-Bureau for each sector.  

Potentially all substances are concerned by the industrial emissions directive, although those 
that are not produced or are only formulated in the EU may not be concerned. 

Pharmaceutical legislation 

The  approval  process  for  medicinal  products  for  human  use  is  described  in  Directive 
2001/83/EC  (Directive  of  the  European  Parliament  and  of  the  Council  on  the  Community 
code relating to medicinal products for human use) 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 product” 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 impact cannot constitute a criterion for refusing 
marketing  authorisation  for  a  human  medicinal  product.  However,  it  is  a  criterion  for 
veterinary medicinal products.  

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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  policy  options  and  that  are  concerned  by  the 
pharmaceuticals legislation are EE2, E2 and Diclofenac. 

Waste legislation 

Waste  legislation  covers  a  large  share  of  the  entire  EU  environmental  acquis  and  includes 
thirteen main legislative acts adopted by the European Parliament and the Council and a large 
number of related decisions adopted through comitology procedures. The overall scope of this 
legislation is the prevention or reduction of waste production, the re-use, the recycling, other 
types of recovery than recycling and the disposal of different categories of waste; permitting 
and control of disposal operations, mainly landfills; and shipments of waste within the EU as 
well as to and from third countries.   

The basic requirements are laid down by the Waste Framework Directive 2008/98/EC which 
is complemented by specific legislation addressing particular environmental threats associated 
with  waste.  This  specific  legislation  includes  harmonised  rules  on  waste  management 
practices, including strict emission limits and operating requirements for the incineration and 
landfill of waste; harmonised rules on shipments  of waste; and product specific  legislation 
setting  targets  for  collection,  re-use,  recovery  and  recycling  and  introducing  producer 
responsibility  principles  for  specific  waste    streams  derived  from  consumer  goods,  in 
particular  packaging  waste,  end  of  life  vehicles,  waste  electrical  and  electronic  equipment, 
mining waste and batteries. 

The  latest  Commission  implementation  report  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 important 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  chemicals,  PPPs  and  biocides,  include 
appropriate mechanisms that can be used to develop process and product controls to address 
the risks identified by the WFD. 

• 

50  

Emission  controls  are  best  suited  to  reducing,  where  necessary,  the  emissions  of  PS.  
However,  they  may  also  be  appropriate  to  control  the  emissions  to  water  of  PHS  of 
natural  origin  or  those  produced  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 

Roig  B,  2010;  EEA,  2010;  SRU,  2007;  Swedish  Medical  Products  Agency,  2009;  Apoteket,  2006; 
CGEDD, 2010. 

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point sources (notably the Urban Waste Water 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 although they may also be useful to reduce 
emissions from a particular use, e.g. by restriction. A range of tools is already available 
in the EU legislation: 

o  Under REACH, the evaluation, restriction and authorisation processes 
o  Under the PPP legislation, the evaluation, restriction and authorisation processes 

and periodic review 

o  Under the biocides legislation, the evaluation, restriction and authorisation 

processes and periodic review 

o  Under the pharmaceuticals legislation, the 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  unacceptable  risks.  PPPs  and  biocides  require  risk 
assessment prior to authorisation. 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  recommend  adequate  risk  management  measures.  Where 
registration  alone  is  not  sufficient  to  manage  the  risks,  restriction  or  authorisation  may  be 
used. 

The WFD identifies PS by assessing the risks to the aquatic environment, largely relying on 
monitoring information. The WFD prioritisation process acts as a safety net to ensure that the 
assumptions and results of the risk assessments carried out for placing in the market of certain 
substances  under  other  legislation,  including  any  mitigation  measures  that  are  applied,  are 
actually delivering adequate protection of water resources and of human health via the aquatic 
environment. The WFD can also identify substances 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  upstream  policies  the  information  gathered  that 
demonstrates  unacceptable  risks,  for  these  policies  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  accompanied  by  an  Environmental  Risk  Assessment. 
However, the results of this assessment are not considered in the risk-benefit balance that is 
the basis of the authorisation for human medicines, though it is for veterinary medicines. As 
regards  human  pharmaceuticals  authorised  before  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  substances  (i.e.  REACH,  PPPs, 
biocides,  pharmaceuticals)  with  the  WFD  priority  substances  process.  The  white  boxes 
indicate WFD processes. The potential role of the watch list as per options C in the text is also 
included.  

The  central  vertical  process  describes  the  main  steps  of  the  WFD  prioritisation  exercise, 
including a risk assessment step that uses data on substances exposure and effects. Upstream 

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policies constitute an important source of data for the WFD prioritisation exercise and on the 
other hand they also benefit from the monitoring data gathered under the WFD.  

Interactions with other policies (waste, industrial emissions) are not included in the diagram. 

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• International lists
• REACH, pesticides, biocides, 
pharmaceuticals
• Research
• Emerging pollutants
• Substances of concern for 
Member States

Universe of chemicals

Member States 
monitoring data

Watch list

REACH 
registration

PPP active substances 
authorisation dossiers

Biocides active substances 
authorisation dossiers

Pharmaceuticals ERA
authorisation dossiers

Exposure data

Effects data

REACH 
evaluation

Prioritisation

Outcome of prioritisation:
• Candidate list of substances
• List of substances not prioritised 
due to lack of information

Expert Group 
assessment

List of substances
for which more 
information is needed

New Priority 
Substances

REACH dossier

PPP active substance 
authorisation review 
Art. 21 Reg 1107/2009

Biocide active substance 
authorisation review 
Art. 10(4) Dir. 98/8/EC

REACH 
restriction

REACH 
authorisation

Legend:

Policy processes
Exchange of information and/or triggers for action between policies

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ANNEX VII: List of stakeholders involved in the consultation  

List of stakeholders members of the Working Group E on Chemical Aspects 

Organisation 

ECPA (European Crop Protection Association) 

Sector 

Pesticides 

Business Europe 

Business organisation 

AESGP (Association of the European Self-Medication Industry) 

Pharmaceuticals 

AISE (International Association for Soaps, Detergents and Maintenance Products)  Detergents 

CEPI (Confederation of European Paper Industry) 

Pulp and paper 

CONCAWE (European Oil Companies' Association for Environment, Health and 
Safety in Refining and Distribution) 

Oil  

EFPIA (European Federation of pharmaceuticals Industries and Associations) 

Pharmaceuticals 

EUCETSA (European Committee of Environmental Technology Suppliers 
Association) 

Equipment suppliers 

EUDA (European Dredging Association) 

Dredgers 

Greenpeace 

Commission OSPAR 

Environmental NGO 

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 Associations of Water Suppliers) 

Water utilities 

EURELECTRIC (The Union of the Electricity Industry) 

Energy  

WWF (World Wild Fund) 

Environmental NGO 

CEFIC (European Chemical Industry Council) 

EUROMETAUX 

EUROFER 

EUROMINES 

Chemical 

Metals 

Metals 

Mining 

The list is also available on the Register of Commission Expert Groups51. 

List of stakeholders addressed in the targeted consultation  

51  

http://ec.europa.eu/transparency/regexpert/detailGroup.cfm?groupID=371, 
"Priority Substances".  

under 

"Sub-groups", 

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Organisation 

FEAP (Federation of European Aquaculture Producers)* 

EMPA/AEPM (European Mollusc Producers Association)*  

Europêche* 

European Anglers' Alliance 

ETF (European Transport Workers' Federation) 

EAPO (European Association of Fish Producer Organisations) 

CESA (Community of European Shipyards Associations) 

COCERAL 

EGA (European Generic Medicines Association) 

CPME  (Standing Committee of European Doctors) 

PGEU (Pharmaceutical Group of the European Union) 

European Patients' Forum 

EPHA  (European Public Health Alliance) 

HAI Europe (Stichting Health Action International Europe) 

HEAL (Health & Environment Alliance) 

BEUC (The European Consumers' Organisation) 

Sector 

Aquaculture 

Aquaculture 

Fisheries 

Angling 

Transport 

Fisheries 

Shipping 

Grain producers 

Pharmaceuticals 

Public Health 

Public Health 

Public Health 

Public Health 

Public Health 

Public Health 

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. 

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ANNEX VIII: References 

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organischen  Spurenstoffen  bei  kommunalen  Abwasserreinigungsanlagen.  Varianten  und 
Kosten. Korrespondenz Abwasser, Abfall 2009, 56:6, 584-592. 

ADAS  UK  Ltd  2010.  Impact  of  changing  pesticide  availability  on  horticulture.  Report  for 
Defra. http://randd.defra.gov.uk/Document.aspx?Document=IF01100_10191_FRP.pdf 

AMAP  2009:  Persistent  Organic  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), Stockholm County Council and Stockholm University.  

Burridge LE, Haya K, Waddy SL, Wade J, 2000. The lethality of anti-sea lice formulations 
Salmosan®  (Azamethiphos)  and  Excis®  (Cypermethrin)  to  stage  IV  and  adult  lobsters 
(Homarus americanus) during repeated short-term exposures. Aquaculture 182, 27-35. 

Cardinale  BJ.  Biodiversity  improves  water  quality  through  niche  partitioning.  Nature  2011, 
472, 86-89.  

CGEDD,  2010.  Conseil  Général  de  l’Environnement  et  du  Développement  durable. 
Médicament  et  environnement.  La  régulation  du  médicament  vis-à-vis  du  risque 
environnemental. Paris, November 2010. 

Chang  H,  Wan  Y,  Wu  S,  Fan  Z,  Hu  J.  Occurrence  of  androgens  and  progestogens  in 
wastewater  treatment  plants  and  receiving  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  the  specific  control  measures  for  priority 
substances  and  priority  hazardous  substances  regulated  under  article  16  of  the  Water 
Framework 
2005. 
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/priority_substances/supporting_background/ecolas_reportpdf/_EN_1.0_&a=d 

Commission 

Directive. 

European 

ENV. 

July 

DG 

Entec,  2011.  Substance  impact  reports.  Prepared  to  support  this  impact  assessment. 
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/priority_substances/supporting_substances 

impact  assessment. 
Entec,  2011b.  Methodology 
http://circa.europa.eu/Public/irc/env/wfd/library?l=/framework_directive/thematic_documents
/priority_substances/supporting_substances 

report.  Prepared 

to  support 

this 

European  Commission,  2006.  Impact  assesssment  of  the  Thematic  Strategy  on  Sustainable 
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European Commission, 2009. White paper - Adapting to climate change: towards a European 
framework for action. COM(2009)147 final.  

European Commission, 2009b. Common Implementation Strategy for the Water Framework 
the  Environmental  Objectives. 
Directive.  Guidance  Document  on  Exemptions 
http://circa.europa.eu/Public/irc/env/wfd/library?l=/framework_directive/guidance_document
s/documentn20_mars09pdf/_EN_1.0_&a=d 

to 

European  Commission,  2011.  Commission  Staff  Working  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 Implementation Strategy for the Water Framework 
Directive.  Technical  Guidance  Document  for  deriving  Environmental  Quality  Standards. 
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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  water  abstraction  by  source  and  by  sector. 
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Herbstman JB, Sjödin A, Kurzon M, Lederman SA, Jones RS, Rauh V, Needham LL, Tang 
D, Niedzwiecki M, Wang RY, Perera F. Prenatal Exposure to PBDEs and Neurodevelopment. 
Environmental Health Perspectives 2010, 118:5, 712-9. 

HGCA  2009.  Pesticide  availability  for  cereals  and  oilseeds  following  revision  of  Directive 
91/414/EEC; effects of losses and new research priorities. 

Inotai  A,    Hankó  B,  Mészáros  A,  2010    Trends  in  the  non-steroidal  anti-inflammatory  drug 
information. 
market 
Pharmacoepidemiol Drug Saf. 19(2) 183-90.  http://www.ncbi.nlm.nih.gov/pubmed/20014174 

in  six  Central-Eastern  European  countries  based  on 

retail 

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  after  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 Framework to Derive Environmental Quality 
Standards  for  Priority  Substances  in  accordance  with  Article  16  of  the  Water  Framework 
Directive (2000/60/EC).  

Roig B, 2010. Pharmaceuticals in the Environment: Current knowledge and need assessment 
to reduce presence and impact. Edited by Benoit Roig. ISBN: 9781843393146. Published by 
IWA Publishing, London, UK. 

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SCHER  (Scientific  Committee  on  Health  and  Environmental  Risks),  Opinion  on  Chemicals 
and the Water Framework Directive: Technical Guidance for Deriving Environmental Quality 
Standards, 
2010. 
http://ec.europa.eu/health/scientific_committees/environmental_risks/docs/scher_o_127.pdf 

October 

SCTEE (Scientific Committee on Toxicity, Ecotoxicity 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 
2004. 
of 
plenary 
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meeting 

May 

28 

SedNet, 2004. European Sediment Research Network. Contaminated Sediments in European 
River Basins. http://www.sednet.org  

SRU,  2007.  German  Advisory  Council  on  the  Environment.  Statement  Nb.  12,  April  2007. 
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the 

in 

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decreased mercury emissions: Projections for 2020. Journal of Cleaner Production 2010, 18, 
386-394. 

Swedish  Medical  Products  Agency,  2009.  Sustainable  Development  and  Pharmaceuticals. 
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