COMMISSION STAFF WORKING PAPER TECHNICAL BACKGROUND
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) 1544 final 

COMMISSION STAFF WORKING PAPER 

TECHNICAL BACKGROUND 

Accompanying the document 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

on the outcome of the review of Annex X to Directive 2000/60/EC of the European 
Parliament and of the Council on priority substances in the field of water policy 

{COM(2011) 875 final} 

 
 
 
 
 
Disclaimer:  This  document  is  a  European  Commission  staff  working  document  and  is  for 
information only. It is not a statement of the Commission's current or future official position 
on the subject it addresses. 

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TABLE OF CONTENTS 

1. 

1.1. 

1.2. 

1.3. 

Review process............................................................................................................. 5 

Tasks ............................................................................................................................ 5 

Participants in the review ............................................................................................. 5 

Summary of approach and outcomes ........................................................................... 6 

1.3.1.  Proposed Priority Substances....................................................................................... 6 

1.3.2.  Existing PS ................................................................................................................... 6 

2. 

2.1. 

2.2. 

2.3. 

Process for prioritisation of new Priority Substances .................................................. 6 

Background .................................................................................................................. 6 

Overall approach to prioritisation ................................................................................ 8 

Risk assessment carried out under the chemicals, plant protection products  and 
biocides legislation....................................................................................................... 9 

2.3.1.  Existing Substances Regulation (EEC) No.793/93...................................................... 9 

2.3.2.  Plant Protection Products legislation Directive 91/414/EEC (Regulation (EC) No 

1107/2009) ................................................................................................................. 10 

2.3.3.  Biocides legislation Directive 98/8/EC...................................................................... 11 

2.4. 

Targeted risk assessments focusing on aquatic ecotoxicity and on human toxicity via 
the aquatic environment ............................................................................................. 11 

2.5. 

Simplified risk-based assessment procedure based on scientific principles .............. 11 

2.5.1.  Monitoring-based prioritisation ................................................................................. 12 

2.5.1.1.  Creation of the database ............................................................................................. 12 

2.5.1.2.  Selection of substances for ranking............................................................................ 14 

2.5.1.3.  Criteria for ranking: consideration of exposure and effects data ............................... 15 

2.5.1.4.  Prioritisation algorithm .............................................................................................. 16 

2.5.1.5.  Additional checks....................................................................................................... 16 

2.5.1.6.  List of substances prioritised through monitoring ..................................................... 17 

2.5.2.  Modelling-based prioritisation ................................................................................... 19 

2.5.2.1.  Starting list: Universe of chemicals ........................................................................... 19 

2.5.2.2.  Data collection: Exposure and hazard assessment ..................................................... 20 

2.5.2.3.  Risk ranking ............................................................................................................... 20 

2.5.2.4.  List of substances prioritised through modelling ....................................................... 21 

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2.6. 

Priority hazardous substances criteria........................................................................ 22 

2.6.1.  REACH Substances of Very High Concern (SVHC) ................................................ 22 

2.6.2.  Persistent Organic Pollutants (POPs) under the Stockholm Convention................... 22 

2.6.3.  Substances identified as Persistent, Bio-accumulative and Toxic (PBTs) under 

Regulation (EEC) No.793/93 ..................................................................................... 22 

2.7. 

2.8. 

Other sources for identification of candidates for prioritisation ................................ 22 

Approach to shortlisting............................................................................................. 23 

2.8.1.  Short-listing from the first candidate list ................................................................... 23 

2.8.2.  Preparation of substance dossiers and further short-listing........................................ 24 

2.9. 

Annex III of EQSD substances .................................................................................. 28 

2.10.  Approach to substances that might pose a specific risk to drinking-water supplies.. 30 

3. 

3.1. 

3.2. 

3.3. 

4. 

4.1. 

4.2. 

Environmental Quality Standards (EQS) derivation and revision ............................. 31 

Technical Guidance on Environmental Quality Standards derivation (TGD EQS) .. 31 

Derivation of EQS for Proposed Priority Substances ................................................ 32 

Revision of EQS for Existing Priority Substances..................................................... 33 

Priority Hazardous Substances (PHS) status.............................................................. 35 

Definition and criteria ................................................................................................ 35 

Review........................................................................................................................ 36 

4.2.1.  Changes to existing Priority Substances .................................................................... 36 

4.2.2.  Proposed new Priority Hazardous Substances ........................................................... 43 

5. 

Technical background documents.............................................................................. 44 

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1. 

REVIEW PROCESS 

1.1. 

Tasks 

In summary, the main tasks of the technical review of the Priority Substances list under the 
Water Framework Directive (WFD1) were to prioritise possible new Priority Substances (PS), 
considering among others the substances in Annex III to the EQS Directive (EQSD2), to set 
appropriate EQS, and to review whether changes should be made to the EQS or status (as PS 
or Priority Hazardous Substances (PHS)) of existing PS. The outputs of the technical process 
were  therefore  a  list  of  possible  new  substances,  EQS  for  them  and  for  some  existing 
substances, and PHS classifications. In addition, and in the context of the subsequent impact 
assessment, the need for additional control measures for existing and new priority substances 
was investigated. 

1.2. 

Participants in the review 

The  technical  process  of  the  review  was  developed  by  the  WFD  Common  Implementation 
Strategy (CIS)3, 4 Working Group E (Chemical Aspects, formerly called Priority Substances), 
operational  since  2007  when  it  superseded  the  Expert  Advisory  Forum  established  in  2001. 
WG  E  contributed  in  various  ways  to  the  review  of  the  EQS  Directive,  supporting  the 
collection  of  data  (including  monitoring  and  hazard  data  and  information  on  control 
measures),  the  prioritisation  exercise,  the  update  of  the  Technical  Guidance  Document  on 
EQS (TGD-EQS) and the derivation of EQS. Two expert groups were set-up as sub-groups of 
WG E: the Expert-Group on the Technical Guidance Document EQS (EG-EQS), and the Sub-
Group  on  Review  of  Priority  Substances  (SG-R).  The  membership  of  WG  E  and  the  two 
expert  groups  consists  of  Commission  DGs,  Member  States  and  stakeholder  organisations 
including a range of industry bodies and NGOs. A list of Members is available on the Register 
of Commission Expert Groups5. 

The SG-R was mandated to support the prioritisation, to propose the candidate substances to 
be  included  in  the  PS  list,  and  to  propose  EQS  for  them  in  water,  sediment  and/or  biota  as 
appropriate.  It  also  provided  advice  on  the  revision  of  water  EQS  and  the  development  of 
sediment  and  biota  EQS  for  existing  PS.  It  was  assisted  in  its  work  by  Commission 
consultants INERIS and the International Office for Water. The outputs of SG-R's technical 
work were regularly presented and discussed in WG E meetings during the review process. 

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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 
Directive  2008/105/EC  of  the  European  Parliament  and  of  the  Council  of  16  December  2008  on 
environmental  quality  standards  in  the  field  of  water  policy,  amending  and  subsequently  repealing 
Council  Directives  82/176/EEC,  83/513/EEC,  84/156/EEC,  84/491/EEC,  86/280/EEC  and  amending 
Directive 2000/60/EC of the European Parliament and of the Council [OJ L 348, 24.12.2008, p. 84–97]. 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:348:0084:0097:EN:PDF  
Common Implementation Strategy (CIS) 

3 
http://ec.europa.eu/environment/water/water-framework/objectives/pdf/strategy.pdf  
4 
http://circa.europa.eu/Public/irc/env/wfd/library?l=/framework_directive/implementation_documents/final_2010

CIS work programme 2011-2012 

5 

-2012/_EN_1.0_&a=d  
http://ec.europa.eu/transparency/regexpert/detailGroup.cfm?groupID=371, 
"Priority Substances".  

under 

"Sub-groups", 

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In support of the EQS-setting and revision processes, it was necessary to update the guidance 
document on EQS derivation. This was done by the EG-EQS in parallel with the prioritisation 
work.  The  EQS  derivation  and  revision  were  then  carried  out  according  to  the  updated 
guidance.  The  guidance  and  the  draft  EQS  were  submitted  to  the  Scientific  Committee  on 
Health and Environmental Risks (SCHER) for its opinion. Further details are provided in later 
sections. 

1.3. 

Summary of approach and outcomes 

1.3.1.  Proposed Priority Substances 

The prioritisation process took account of several information sources and arrived at a short-
list of 19 substances, for which EQS were derived, though not all the substances appear in the 
proposal for the reasons explained in section 2.8.2. 

During  the  review,  particular  consideration  was  given  to  the  substances  in  Annex  III  to  the 
EQSD.  Section  2.9  explains  how  these  substances  ranked  in  relation  to  others  shortlisted 
during  the  prioritisation  process,  and  what  led  to  their  inclusion  in  or  exclusion  from  the 
options and the final proposal. 

Consideration was also given to substances that might pose a particular risk to drinking water 
supplies.  Data  were  requested  from  WG  E  on  concentrations  of  such  substances  in  water 
bodies used for the abstraction of drinking water, and in drinking water itself. For none of the 
substances were the data conclusive. For this reason, no substances were identified that would 
require the setting of a standard specific to water bodies used for the abstraction of drinking 
water. Section 2.10 provides more details. 

For  all  the  proposed  priority  substances,  consideration  was  given  to  their  hazardousness  (in 
particular as judged under other legislation) and the exposure of the aquatic environment (and 
humans  via  the  aquatic  environment)  to  them  in  order  to  determine  whether  they  should  be 
classified  as  PHS.  Six  were  identified  as  PHS.  The  considerations  for  each  substance  are 
summarised in section 4.2.2. 

1.3.2.  Existing PS 

A review of new risk assessments of the existing PS led to the conclusion that the EQS for 
seven substances should be revised and/or established for biota instead of water. Details are 
provided in section 3.3. 

New information that might affect the status of existing PS was also reviewed, and this led to 
the proposal that two existing substances be reclassified as PHS, as outlined in section 4.2.1. 

2. 

PROCESS FOR PRIORITISATION OF NEW PRIORITY SUBSTANCES 

2.1. 

Background 

According  to  WFD  Article  16(1),  the  Commission  should  identify  priority  substances  (PS) 
among  those  presenting  a  significant  risk  to  or  via  the  aquatic  environment,  including  such 
risks  to  waters  used  for  the  abstraction  of  drinking  water.  Article  16(2)  establishes  that  the 
identification of PS should be based on  

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1.  Risk  assessment  carried  out  under  the  chemicals,  pesticides  (plant  protection  products) 
and  biocides  legislation  (Regulation  (EEC)  No.793/93,  Directive  91/414/EEC  (now 
Regulation (EC) No 1107/2009) and Directive 98/8/EC respectively) 

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

aquatic environment 

3.  Simplified risk-based assessment procedure based on scientific principles taking particular 

account of  

•  Evidence regarding the intrinsic hazard of the substances,  

•  Evidence from monitoring of widespread contamination  

•  Other  elements  that  may  indicate  widespread  contamination  such  as  production 

volumes and use patterns 

At the time the first identification of PS was carried out (list of 33 PS established in 2001 by 
Decision  2455/2001/EC),  very  few  risk  assessment  were  available  under  the  chemicals, 
pesticides  and  biocides  legislation.  The  COMMPS  (combined  monitoring-based  and 
modelling-based  priority  setting)  procedure6  was  developed  as  a  simplified  risk-based 
assessment that combined the available information on the intrinsic hazard of substances (first 
bullet  under  point  3  above)  with  estimates  of  exposure  based  on  monitoring  information 
(second  bullet  under  point  3  above)  and  modelling  information  derived  from  production 
volumes and use patterns (third bullet under point 3 above).  

The  current  situation  is  very  different  from  ten  years  ago  in  that  the  implementation  of  the 
legislations  on  chemicals,  pesticides  and  biocides  has  progressed  substantially.  Risk 
assessments  have  been  concluded  for  many  substances  and  need  to  be  taken  into  account 
when  identifying  priority  substances  under  the  WFD.  In  addition,  risk  assessments  are 
available  in  draft  stage  for  a  number  of  substances  and  other  substances  have  undergone 
voluntary risk assessments. 

At  the  time  of  development  COMMPS  was  welcomed  as  a  pragmatic  approach  towards 
prioritisation.  The  Scientific  Committee  on  Toxicity,  Ecotoxicity  and  the  Environment 
published an opinion on COMMPS7 that identified a number of elements for improvement in 
the future. This opinion and the discussions among Commission services, Member States and 
stakeholder  experts  were  considered  in  the  development  of  an  improved  methodology  for 
prioritisation.  This  was  developed  (starting  in  2007)  by  the  Working  Group  E  on  Chemical 
Aspects under the WFD Common Implementation Strategy (CIS).  

The  following  sections  explain  how  the  three  bases  for  PS  identification  presented  in  WFD 
Article 16(2) have determined the methodology used in the current review. 

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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 
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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2.2. 

Overall approach to prioritisation 

The overall approach was based on the criteria set out in the WFD Article 16(2) and built on 
the experience gained with the COMMPS procedure (see below). It is recognised that there is 
no single approach that is best for prioritisation, all have their advantages and disadvantages. 
A combination of different approaches was considered the best to identify candidates for the 
priority list.  

The approaches were based on the following, which were developed as parallel prioritisation 
processes and subjected to expert review: 

• 

• 

• 

• 

• 

Risk assessment carried out under the chemicals, pesticides and biocides legislation  

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

Simplified  risk-based  assessment  procedure  based  on  scientific  principles  taking 
particular account of  

– 

– 

– 

Evidence regarding the intrinsic hazard of the substances, and 

Evidence from monitoring of widespread environmental contamination and 

Other elements that may indicate widespread contamination such as production 
volumes and use patterns 

Priority  Hazardous  Substances  criteria  (PBT  or  equivalent  level  of  concern), 
including Substances of Very High Concern under REACH and POP criteria 

Other sources of information 

– 

– 

Substances of concern at Member State level 

Annex III of EQSD Directive 2008/105/EC 

The processes led to separate but complementary lists of substances. The lists or at least the 
highest-priority  substances  on  each  list  were  amalgamated  and  subjected  to  a  short-listing 
procedure involving further expert review. The range of processes took advantage of the most 
relevant  available  information.  Inevitably  there  was  some  overlap  between  the  lists,  despite 
the  independence  of  the  processes,  and  this  made  the  case  for  prioritising  some  substances 
particularly strong. The individual processes and the short-listing procedure are illustrated in 
Figure 1 and described in the following sections. The short-listed substances were subject to a 
detailed  expert  review  on  the  basis  of  dossiers  prepared  by  the  Commission  and  Member 
States experts in the Sub-Group on Review. 

The following sections describe more in detail the different sources of prioritisation and how 
the short-listing was carried out. 

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EU Risk
EU Risk
Assessment Reports
Assessment Reports

Targeted risk
Targeted risk
-based assessment
-based assessment

Monitoring-based 
Monitoring-based 
ranking
ranking

Modelling--based 
based 
Modelling--based 
based 
Modelling
Modelling
ranking
ranking
ranking
ranking

PHSPHS
PHSPHS

sources
OtherOther sources
OtherOther sources
sources

List 
List 
of substances 
of substances 

List 
List 
of substances
of substances

SVHC, POPs,
SVHC, POPs,
PBT
PBT

Annex III 
Annex III 
substances,
substances,
substances of 
substances of 
concern for 
concern for 
Member States
Member States

Establish the 
Establish the 
universe of 
universe of 
substances
substances

Establish the 
Establish the 
manageable list
manageable list

Evaluate the 
Evaluate the 
exposure and 
exposure and 
effects data
effects data

Apply the 
Apply the 
prioritisation 
prioritisation 
algorithm
algorithm

Establish the 
Establish the 
universe of 
universe of 
substances
substances

Assess the 
Assess the 
exposure and 
exposure and 
hazard data
hazard data

Risk ranking 
Risk ranking 
(Scoring)
(Scoring)

Apply the 
Apply the 
fugacity model
fugacity model

A posteriori check
A posteriori check

Expert review
Expert review

List of substances 
List of substances 

List of substances
List of substances

Expert review
Expert review

Final list of candidate PS
Final list of candidate PS

Establish EQSs
Establish EQSs

Figure 1: Overall approach to prioritisation  

2.3. 

Risk assessment carried out under the chemicals, plant protection products and 
biocides legislation8  

2.3.1.  Existing Substances Regulation (EEC) No.793/93 

From 1994 to 2009, a total of 4 priority lists comprising 141 substances were drawn up by the 
Commission  in  consultation  with  Member  States  to  carry  out  risk  assessments  under 
Regulation (EEC) No.793/93 (see http://esis.jrc.ec.europa.eu/). Risk assessment reports were 
concluded  for  102  substances.  Among  those,  and  without  counting  existing  PS,  49  pose 
identified risks to or via the aquatic environment and for 35 a Commission Recommendation 
to reduce risk has been published in the Official Journal.  

The risk assessment reports (RAR) for existing chemicals that included a conclusion iii9 for 
the aquatic environment were screened to extract the Predicted Environmental Concentrations 
(PECs), Predicted No Effect Concentrations (PNECs) and risk ratios.  

The  following  criteria  were  applied  when  considering  whether  to  further  consider  the 
substance: 

8 
9 

The information on this section reflects the situation at the time of performing the review (mid 2009). 
Conclusion (iii): There is a need for limiting the risks; risk reduction measures which are already being 
applied shall be taken into account. 

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• 

• 

• 

The  default  option  was  to  select  the  substance  for  further  review  in  view  of  the 
conclusion iii on risks to or via the aquatic environment. 

Only final RARs were considered. Draft RAR were not deemed sufficient to consider 
the substance further. 

If the risk assessment clearly indicated that the conclusion iii was reached for a local 
scenario  or  for  only  a  few  sites,  and  the  scenario  was  not  likely  to  be  present  in  a 
significant  number  of  river  basins  in  the  EU,  the  substance  was  not  considered 
further.  If  the  risk  was  labelled  "local"  but  related  to  widespread  uses  then  it  was 
deemed  appropriate  to  identify  the  substance  for  further  review.  In  case  of  doubt 
about  whether  the  use  was  widespread  or  not  the  substance  was  kept  for  further 
review. 

The assessment concluded with 12 substances selected for preparation of detailed dossiers out 
of the 49 substances with conclusion iii for the aquatic environment.  

2.3.2.  Plant  Protection  Products  legislation  Directive  91/414/EEC  (Regulation  (EC)  No 

1107/2009) 

As at 23 June 2009, 334 active substances were included in Annex I of Directive 91/414/EEC, 
i.e. authorised for use in plant protection products, and 766 active substances had been subject 
to a non-inclusion decision. Annex I of Directive 91/414/EEC identifies 151 of the 334 active 
substances authorised as needing risk reduction measures due to the risk to surface waters.  

The Sub-Group on Review decided not to investigate further those plant protection products 
(PPPs)  that  have  been  authorised,  and  are  therefore  included  in  Annex  I  to  Directive 
91/414/EEC, but for which there is no other source of information for prioritisation, i.e. they 
are  not  ranked  high  in  either  the  monitoring-based  or  the  modelling-based  approach,  nor 
identified  as  a  PBT,  POP,  SVHC  or  Annex  III  substance.  PPPs  subject  to  a  non-inclusion 
decision  under  Directive  91/414/EEC  and  not  ranking  high  in  any  of  the  ranking  exercises 
were also not investigated further. 

The  Sub-Group  considered  information  on  the  peak  concentrations  of  the  PPPs  in  the 
monitoring database in order to ensure that the averaging involved in the PEC calculation in 
the monitoring-based prioritisation did not overlook important information on short-lived high 
concentrations.  

The  risk  assessments  for  the  remaining  11  PPPs  were  screened  to  extract  the  relevant 
information. The Toxicity Exposure Ratios (TERs) were used to rank the PPPs as far as the 
available information allowed. Eight out of the 11 PPPs ranked high in the modelling-based 
prioritisation and 4 out of 11 ranked high or very high in the monitoring-based prioritisation. 
Methiocarb  (aka  mercaptodimethur)  and  Deltamethrin  ranked  very  high  in  the  monitoring-
based  prioritisation  but  were  proposed  for  de-selection  because  the  available  monitoring 
information was not sufficiently representative of an EU risk and had not been identified by 
any other prioritisation process. 

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2.3.3.  Biocides legislation Directive 98/8/EC 

At the time of short-listing there were 29 active substances in Annex I of Directive 98/8/EC, 
i.e.  authorised  for  use.  Of  those,  the  annex  identifies  risks  to  the  aquatic  environment  in  13 
cases. Around 300 active substances were under review at that moment. 

The  same  criteria  were  applied  to  biocides  as  to  PPPs,  i.e.  no  further  investigation  was 
proposed if the substance was not ranked high in any of the ranking exercises and they were 
not identified as a PBT, POP, SVHC or Annex III substance.  

Only  one  substance  remained  after  applying  these  criteria:  Tolylfluanid,  which  is  also 
authorised as a PPP. Its risk assessment under the biocides legislation was examined and the 
substance was further investigated. 

2.4. 

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

On the basis that voluntary risk assessments had been concluded by industry on Copper and 
by  the  UK  on  PFOS,  in  both  cases  showing  conclusion  iii  for  the  aquatic  environment  for 
some scenarios and uses, these substances were further reviewed. 

2.5. 

Simplified risk-based assessment procedure based on scientific principles 

A  simplified  assessment  procedure  was  developed  for  the  current  prioritisation  by  the  Sub-
Group  on  Review,  largely  building  on  the  experience  of  COMMPS  and  the  opinion  on  this 
methodology  received  from  the  Scientific  Committee  on  Toxicity,  Ecotoxicity  and  the 
Environment10  (SCTEE,  now  Scientific  Committee  on  Health  and  Environmental  Risks  – 
SCHER).  

The Sub-Group decided to run the following 2 methodologies in parallel: 

– 

– 

A  monitoring-based  methodology  elaborated  by  DG  Environment’s  consultant 
INERIS-IOW, and 

A modelling-based methodology developed by the Sub-Group based mainly on an 
UK methodology modified and implemented by the JRC 

The methodologies complement each other, as the SCTEE recognised in its opinion11. Both 
incorporate information on the intrinsic hazard of substances, i.e. first bullet under point 3 in 
section 2.1 above. The monitoring-based methodology builds on the second bullet under point 
3 in section 2.1 above and the modelling-based methodology on the third bullet under point 3. 

10 

11 

of 

28 

on 

the 

SCTEE 

adopted 

September 

Opinion 
http://ec.europa.eu/health/ph_risk/committees/sct/docshtml/sct_out49_en.htm  
“Monitoring data provide an excellent basis, from direct  observation, to get information on European 
environmental  conditions.  However,  monitoring  data  cannot  be  used  as  the  single  scoring  method 
because  the  available  information  is  incomplete  and  only  covers  a  set  of  substances  which  were 
considered  "relevant"  in  the  past.  Thus,  the  current  monitoring  information  is  biased  by  previous 
decisions  on  which  substances  should  be  monitored.  (…)  Therefore,  it  is  important  to  incorporate  a 
second system, to allow inclusion in the final list, of substances with a high potential risk for aquatic 
organisms  for  which  no  monitoring  information  is  available  to  date.”  Cf.  Opinion  of  the  SCTEE  of 
28.09.1999. 

available 

1999, 

at 

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2.5.1.  Monitoring-based prioritisation 

As  recognised  by  the  SCTEE,  the  monitoring-based  approach  is  an  excellent  basis  for 
prioritisation as it provides direct evidence of the presence of substances in the environment.  

A  preliminary  monitoring-based  prioritisation  was  conducted  in  2008  leading  to  the 
compilation  of  a  database  and  a  first-stage  ranking  report.  Following  extensive  discussions, 
gaps  and  improvements  were  identified  and  a  second  data  collection  and  an  improved 
prioritisation methodology were implemented. A monitoring-based list of substances was then 
proposed.  The  steps  involved  were:  data  gathering,  selection  of  relevant  substances  to  rank, 
definition  and  application  of  the  criteria  for  ranking,  development  and  application  of  the 
algorithm for ranking, additional checks, and identification of the final monitoring-based list 
of substances. These are described in detail below. 

2.5.1.1.  Creation of the database 

The monitoring-based ranking used raw monitoring data collected in EU Member States (all 
except  Malta)  and  other  European  countries  (Norway  and  Switzerland).  Minimum 
information criteria for use of the data in the prioritisation were defined. With each analysis, 
22 mandatory pieces of information were required, and a large set of additional information if 
available.  The  Sub-Group  developed  a  template  for  the  data  collection  which  was 
implemented in a data-collection tool. This tool was used by almost every country to prepare 
its dataset: gather individual data, check for completeness, and export the resulting dataset for 
submission  to  the  Commission.  In  the  received  datasets,  various  validity  checks  were 
implemented before the data were gathered in a central database. 

Datasets
Datasets

Data collection 
Data collection 
template
template

Data collection Tool
Data collection Tool

Internal checks (CAS, 
Internal checks (CAS, 
name, date…) and 
name, date…) and 
treatments (units, 
treatments (units, 
determination limits)
determination limits)

Central database
Central database

Figure 2: Data collection, template, tool and database 

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Many differences in presentation and content were found, including the use of more than 150 
different units. Some preliminary treatment was therefore necessary, e.g. to express all results 
in µg/l for water analyses and µg/kg for sediment and biota analyses.  

Overall,  14.6  million  analyses  from  19  900  stations  in  28  countries  and  covering  1151 
substances were reported.12 All 4 WFD surface water categories (rivers, lakes, transitional and 
coastal  waters)  were  represented,  river  stations  being  predominant  as  illustrated  in  the 
following map (Figure 3). 

12 

This compares with 750 000 analyses from the EU15 for water and sediment in the database compiled 
for the COMMPS procedure. 

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Data were provided on three fractions of water, four fractions of sediment and eight fractions 
of biota, water data being by far the most dominant. 

2.5.1.2.  Selection of substances for ranking 

Considering  the  tight  schedule  and  the  available  resources,  it  was  not  possible  to  use  the 
complete dataset. In addition, Figure 4 on the number of countries that reported data on the 
various substances (independent of fraction) shows that most substances were reported on by 
only a small number of countries, hence not necessarily representative of the situation in the 
EU. 

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Figure 4: Number of countries reporting data per substance 

1151

1200

s
e
c
n
a
t
s
b
u
s

f
o
r
e
b
m
u
N

1000

800

600

400

200

0

606

430

316

250208174144124106 74 69 66 57 52 47 38 32 26 21 17 7 3 1 1

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Number of countries

Since  the  WFD  intends  that  PS  be  of  EU-wide  concern,  the  ranking  step  was  restricted  to 
substances monitored in at least 4 countries, i.e. to 316 substances.  

2.5.1.3.  Criteria for ranking: consideration of exposure and effects data 

The prioritisation took account of the combination of: 

• 

• 

exposure  data  (Predicted  Environmental  Concentration)  expressed  as  a  single 
concentration, based on the available EU monitoring data, and 

effect  data  (Predicted  No  Effect  Concentration)  selected  from  the  literature  for  the 
sole purpose of prioritisation. 

The exposure data were calculated from the monitoring data as arithmetic means at the level 
of each monitoring station for each analysed fraction (whole water, dissolved metals in water, 
sediment  below  2mm,  below  63µm,  below  20µm,  fish  and  invertebrates),  and  then  as  90th 
percentiles  of  the  means  from  all  stations.  If  collected  data  are  representative  of  the  EU 
situation, 90% of the stations would be expected to experience average concentrations below 
this  value,  i.e.  below  the  PEC.  In  terms  of  risk  assessment,  this  implies  that  if  the  PEC  is 
below  the  PNEC,  90%  of  the  station  locations  are,  on  average,  expected  to  present  safe 
concentrations.  In  practice,  difficulties  arise  because  of  measurements  that  are  below  the 
analytical determination limit. Two PEC calculations were consequently calculated, one using 
only  quantified  values  (PEC1),  the  other  using  all  available  data  (PEC2).  In  the  latter  data 
below the determination limit was replaced by half its value as recommended by the QA/QC 
Directive (2009/90/EC)13. 

Two  PEC/PNEC  risk  ratios  could  then  be  derived  for  each  fraction  (where  data  were 
available).  In  some  cases  the  results  may  have  reflected  insufficient  analytical  performance 
rather than real risk. It was therefore necessary to assess the relevance of the ratios. This was 
done  first  by  discarding  cases  where  the  risk  based  on  PEC2  was  >1  whilst  that  based  on 

13 

Commission Directive on technical specifications for chemical analysis and monitoring of water status, 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:201:0036:0038:EN:PDF  

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PEC1 was <1, second by checking that PEC1 > PEC2, and third by considering for ranking in 
the  monitoring-based  prioritisation  only  the  substances  where  the  number  of  quantified 
analyses is more than 2% of the total number of analyses. 

The  effect  data  considered  were  ecotoxicity  data  for  the  different  fractions  covered  by  the 
monitoring  data.  They  were  obtained  during  an  extensive  literature  review  in  the  spring  of 
2009. For water, direct ecotoxicity was considered and a PNEC calculated using the original 
Technical  Guidance  Document  on  Risk  Assessment.  For  sediment,  PNEC  values  were 
calculated by applying the Equilibrium Partitioning method using PNECwater and Koc as input 
parameters. For biota, risk of secondary poisoning for predators and risk to human health via 
consumption of contaminated aquatic biota were assessed and the PNEC based on the higher 
risk. 

Drinking  water  standards  were  compared  with  the  PECs  to  provide  an  indication  of  the 
removal  efficiency  that  might  be  required  to  produce  drinking  water.  For  metals,  PNECs  in 
water and biota were proposed, based on substance factsheets or on the relevant RARs.  

2.5.1.4.  Prioritisation algorithm 

For  each  fraction,  five  risk-ratio  categories  were  defined:  Very  High,  High,  Medium,  not 
Applicable and Low14. The overall priority is defined by the maximum priority amongst the 
calculated risk ratios for all fractions. 

Specific  cases  were  made  for  substances  relevant  to  drinking  water,  where  drinking  water 
standards  or  guidelines  were  considered  in  place  of  the  PNEC  for  the  ratio  calculation. 
Specific  cases  were  also  made  for  PCBs,  where  results  for  total  PCBs  were  compared  to 
results on each individual PCB, and to the sum of these individuals. Specific case is also made 
for  dioxins/furans  where  the  sum  of  all  dioxin  like  substances  is  made  using  the  Toxic 
Equivalent Factor (TEF) approach. 

2.5.1.5.  Additional checks 

Substances in the very high and high categories were selected for additional checks15. Since 
not all fractions needed to be classified in these categories to make the substance rank high or 
very high, it was important to check the EU representativeness of the monitoring data for the 
fraction(s)  leading  to  this  ranking.  Additional  checks  on  the  quality  and  reliability  of  the 
monitoring data were also done to ensure that the selection had a solid basis. As a result of 
these checks, some substances were identified as candidates for de-selection. 

In particular, when the substance was not monitored by at least 3 countries in the determinant 
fraction resulting in high or very high risk, the substance was identified as candidate for de-
listing  subject  to  a  final  consideration.  Non-quantified  analyses  for  which  the  limit  of 
determination  was  more  than  twice  the  PNEC  were  considered  unreliable.  The  PEC  values 
and risk ratios were recalculated without these data and if the substance was no longer ranked 
as  very  high  or  high  it  was  identified  as  a  candidate  for  de-selection,  also  subject  to  a  final 
consideration. 

14 
15 

See INERIS-IOW (2009), annex IX for exact definition 
See INERIS-IOW (2009), annex XII 

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2.5.1.6.  List of substances prioritised through monitoring 

After application of the algorithm and the additional checks, a list of 36 organic compounds 
and 4 metals was obtained, 19 of these identified for de-selection.  

Table 1: List of substances prioritised through monitoring 

No.  SubstanceName 

CAS 

  No. SubstanceName 

1  Heptachlor epoxide 

1024-57-3 

  28  Mevinphos 

CAS 

7786-
34-7 

2  Heptachlor 

76-44-8 

  29  Chloroacetic acid* 

79-11-8 

3 

Permethrin* 

52645-53-1   30  Methidathion* 

4  Cyanides 

57-12-5 

  31 

Monobutyl tin 
compounds 

5  Malathion* 

121-75-5 

  32  2,4-Dichlorophenol* 

6  Methiocarb* 

2032-65-7 

  33  Dioxins/Furans 

7  Cypermethrin 

52315-07-8  

Dioxins/Furans/PCB 
dioxin-like 

8  Deltamethrin* 

52918-63-5   34  PCBs 

9 

Parathion 

56-38-2 

10  Dichlorvos 

62-73-7 

11 

12 

Dichlorodiphenyl 
dichloroethane - o,p' 

53-19-0 

Tetrabutyltin 
compounds* 

13  Triphenyltin compounds*    

14  Dicofol* 

115-32-2 

15  Fenitrothion* 

122-14-5 

PCBs - worst case 3 
approaches 

2',3,4,4',5'-
Pentachlorobiphenyl 

2,3,3',4,4'-
Pentachlorobiphenyl 

2,2',4,4',5,5'-
Hexachlorobiphenyl 

2,2',3,4,4',5'-
Hexachlorobiphenyl 

2,2',3,4,4',5,5'-
Heptachlorobiphenyl 

2,2',5,5'-
Tetrachlorobiphenyl 

950-37-
8 

120-83-
2 

31508-
00-6 

32598-
14-4 

35065-
27-1 

35065-
28-2 

35065-
29-3 

35693-
99-3 

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No.  SubstanceName 

CAS 

  No. SubstanceName 

CAS 

16  Diazinon* 

333-41-5 

17  Omethoate 

1113-02-6 

18  Nitrite 

14797-65-0  

19  Phoxime 

14816-18-3  

2,3,3',4,4',5-
Hexachlorobiphenyl 

2,4,4'-
Trichlorobiphenyl* 

2,2',4,5,5'-
Pentachlorobiphenyl 

3,3',4,4'-
Tetrachlorobiphenyl 

20  Chloroxuron 

1982-47-4 

PAHs 

21  Azinphos-ethyl 

2642-71-9 

  35  Pyrene 

38380-
08-4 

7012-
37-5 

37680-
73-2 

32598-
13-3 

129-00-
0 

22  Pirimiphos-methyl* 

29232-93-7   36  Benzo(a)anthracene 

56-55-3 

23  Trichlorfon* 

52-68-6 

   Metals 

24 

2,2',4,4'-
Tetrabromodiphenyl 
ether* 

5436-43-1 

  37 

Arsenic (and mineral 
compounds)* 

25  Fenthion 

55-38-9 

  38  Selenium* 

26  Chlorpyrifos-methyl 

5598-13-0 

  39  Uranium* 

27  Methoxychlor 

72-43-5 

  40  Vanadium* 

* candidate for de-listing 

7440-
38-2 

7782-
49-2 

7440-
61-1 

7440-
62-2 

The  Sub-Group  on  Review  agreed  that,  due  to  the  limitations  in  the  monitoring  data, 
substances identified for de-selection should not be subject to further scrutiny in this review if 
their  presence  in  the  list  of  candidate  substances  was  due  only  to  monitoring-based 
prioritisation.  

Dicofol and Trichlorfon ranked high also in the modelling-based prioritisation. Dicofol is also 
a  PBT  and/or  vPvB  and  is  in  Annex  III  of  the  EQSD.  Tetrabutyltin  compounds  were 
is  a  SVHC  under  REACH.  3,3',4,4'-
identified  as  PBT  and/or  vPvB.  Arsenic 
Tetrachlorobiphenyl  (PCB  77)  is  a  POP.  Therefore  these  five  substances  were  retained  for 
further scrutiny.  

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2,2',4,4'-Tetrabromodiphenyl ether ranked high in the monitoring-based prioritisation but was 
deleted  from  the  list  of  candidate  substances  because  it  is  an  existing  PS  (brominated 
diphenylether congener BDE-47).  

The other substances out of the 19 that were identified as candidates for de-selection were not 
considered further. 

The  PAHs  ranking  high  in  the  monitoring-based  ranking  (pyrene  and  Benzo(a)anthracene) 
were also not proposed for further consideration as PAHs are already included in the PS list. 

The remaining substances were then considered alongside those in the other lists of candidate 
substances for prioritisation.  

Twelve  substances  were  identified  for  which  the  ratio  between  the  PEC  and  the  drinking 
water standards was high, i.e. substances for which high treatment removal efficiency would 
be  necessary,  and  which  might  therefore  cause  failure  of  the  drinking  water  standard  at  the 
tap. These were not immediately scrutinised further unless other sources of prioritisation were 
relevant. The issue of substances that might pose a risk to drinking water supplies is addressed 
in section 2.10. 

The detailed information collected for the monitoring-based prioritisation, and the quantity of 
analyses collected allowed a more complex approach than COMMPS, and consequently gave 
more  representative  results.  However,  the  methodology  used  to  select  the  substances  was 
based on the arithmetic mean by station and did not consider seasonal emission patterns. This 
was identified as a limitation of the methodology that could be addressed in future exercises. 

2.5.2.  Modelling-based prioritisation 

The modelling-based ranking involved the following steps: identification of a starting list of 
substances,  data  collection  (exposure  and  hazard  assessment),  application  of  the  ranking 
methodology, definition of a final modelling-based list of substances. These steps, which were 
carried out by the Joint Research Centre (JRC), are described below. 

2.5.2.1.  Starting list: Universe of chemicals 

The first step in the modelling based approach was to define the list of substances to which to 
apply the ranking methodology. Various sources where used: monitoring data from Member 
States (MS), substances proposed by the European Parliament (EP) for further investigation, 
stakeholders,  research  consortia,  international  organisations,  and  several  EU  lists  of 
substances of possible concern such as PBTs, possible endocrine disruptors, plant protection 
products,  etc.  All  these  lists  were  merged  together  to  form  a  combined  list  of  2034 
compounds. Metals were excluded from this list as the majority of the tools developed for the 
estimation  of  physical,  chemical  and  toxicological  properties  have  been  developed  to  deal 
with organic compounds rather than metals. 

Simplified  Molecular  Input  Line  Entry  Specification  (SMILES)  codes  (descriptions  of 
molecular structure in short ASCII strings) were generated for 1872 substances for use in the 
modelling. 

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2.5.2.2.  Data collection: Exposure and hazard assessment 

Each  substance  was  subjected  to  a  hazard  assessment  following  the  REACH  Guidance  on 
Information  Requirements  and  Chemical  Safety  Assessment.  It  comprised  four  criteria: 
Persistence, Bioaccumulation, Toxicity and Endocrine Disrupting properties. When a criterion 
was fulfilled, a score of 1 was given and the scores were added. If a substance was vPvB, a 
score of 4 was attributed. In the absence of sufficient information to conclude, QSAR models 
were used as surrogates. 

The assessment of persistence (P) was made using BIOWIN (1727 substances of which 691 
were  P)  or  BIOHCWIN  (142  substances  of  which  41  were  P)  from  the  EPIsuite,  whilst  to 
estimate very P (vP), the OECD Pov and LRTP screening tools were used. 

To  assess  bioaccumulation  (B),  measurements  of  the  BioConcentration  Factor  (BCF)  in 
aquatic  species  were  preferred,  and  B  was  attributed  when  2000<BCF<5000  L/kg,  very  B 
(vB)  when  BCF>5000  L/kg,  whereas  if  the  Log  Kow  <=4,5  and  no  specific  mechanism  of 
uptake was identified, the substance was considered as neither B nor vB. Experimental BCF 
was  used  but  in  the  absence  of  data,  other  information  was  used  in  a  weight-of-evidence 
approach, including worst-case QSAR estimated values based on three modelling approaches.  

To assess toxicity (T), REACH Annex XIII criteria were used: either a long-term no-observed 
effect  concentration  (NOEC)  of  less  than  0.01mg/l,  or  the  substance  was  identified  as 
carcinogenic,  mutagenic  or  toxic  for  reproduction,  or  the  substance  had  chronic  toxicity 
effects  identified  by  a  risk  phrase  under  Directive  67/548/EEC.  Acute  studies  provided 
evidence of T but this needed to be complemented by chronic tests on fish, daphnia or algae. 
In their absence, the screening was finalised by applying four QSAR models generated by the 
ADMET  modeller  software  to  derive  acute  aquatic  toxicity,  T  being  assigned  if  3  of  the  4 
QSARs agreed on T classification.  

The  above  scores  were  summed  to  obtain  a  hazard  score.  The  exposure  was  then  assessed 
through  collection  of  data  on  use  of  the  substances  in  products  using  the  IUCLID  database 
and  SPIN.  The  IUCLID  database  (http://iuclid.echa.europa.eu/)  contains  data  collected 
through an obligation on producers and importers of high-production-volume chemicals and 
low-production-volume chemicals. The SPIN database contains data from Nordic countries on 
the use of substances in products (http://www.spin2000.net) and was used when no data were 
found in IUCLID, applying an extrapolation factor to derive a European tonnage. Use patterns 
were applied to generate release indices. When several uses were possible, the most dispersive 
was selected. An exposure score was then attributed. Only 737 substances could be assessed 
due to limitations in the data availability. 

The exposure score was combined with the hazard score to derive a risk score, and only the 
78 substances classified at the top of the resulting matrix were selected. 

2.5.2.3.  Risk ranking 

The  subset  of  78  substances  selected  for  their  risk  score  were  classified  using  a  risk  ratio 
approach.  Predicted  Environmental  Concentrations  (PEC)  were  calculated  using  two 
approaches:  a  multimedia  model  and  a  tiered  approach  developed  by  ECETOC  to  calculate 
the  exposure  and  related  risks  to  consumers,  workers  and  the  environment  caused  by 
chemicals.  Predicted  No  Effect  Concentrations  (PNECs)  were  also  calculated,  using 
experimental data where possible. PEC/PNEC ratios were then used to rank the substances. 

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2.5.2.4.  List of substances prioritised through modelling 

The list of 78 substances is presented in the following table. Some of these substances were 
also selected by the monitoring based prioritisation. 

Table 2: List of substances prioritised through modelling 

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2.6. 

Priority hazardous substances criteria 

PHS  are  a  subset  of  PS  that  are  identified  as  being  “toxic,  persistent  and  liable  to  bio-
accumulate,  and  other  substances  or  groups  of  substances  which  give  rise  to  an  equivalent 
level  of  concern”  (WFD  article  2(29)).  In  this  context,  the  substances  identified  by  the 
following processes and legislations are relevant: 

2.6.1.  REACH Substances of Very High Concern (SVHC) 

At the time of initial listing for the PS review, 15 had been identified, 3 of them already PS; 
overall, in 2008 and 2009, 32 substances were proposed as SVHC, many of them already PS 
or  PHS.  Two  were  not  relevant  to  the  aquatic  environment.  The  remaining  12  substances16 
were retained on the PS candidate list until it was decided not to consider further substances 
proposed  for  SVHC  classification  on  the  basis  of  CMR  properties  only  unless  there  was 
evidence  that  the  substances  were  relevant  for  the  aquatic  environment.  Acrylamide, 
Benzylbutylphthalate 
(MDA),  2,4-dinitrotoluene, 
Arsenic  and  its  mineral  compounds,  Chromium  and  its  compounds  and  Cobalt  and  its 
compounds were then not investigated further. 

(BBP),  4,4`-diaminodiphenylmethane 

2.6.2.  Persistent Organic Pollutants (POPs) under the Stockholm Convention 

At the time of initial listing for the PS review, 12 substances were on the POPs list and 9 more 
were in the process of being added after the agreement at the Conference of the Parties in May 
2009, i.e. a total of 21 substances, 10 of them not PS. Of the 1317 identified as POPs by the 
end of 2009, only those prioritised also by other processes were considered further, to avoid 
looking at substances which are not relevant for the aquatic environment in the EU.  

2.6.3. 

Substances  identified  as  Persistent,  Bio-accumulative  and  Toxic  (PBTs)  under 
Regulation (EEC) No.793/93 

At the time of initial listing for the PS review, 27 substances had been identified, 9 of them 
not  PS.  PBT  properties  were  taken  into  consideration  in  the  modelling-based  prioritisation. 
Out  of  the  13  PBT/vPvB  substances  included  on  the  list  of  candidate  substances  in  the 
modelling  exercise,  9  substances  ranked  high,  one  of  which  ranked  high  also  in  the 
monitoring-based  prioritisation  (Tetrabutyltin  compounds).  Tetramethyllead  was  not 
considered  further  because  it  is  no  longer  produced  in  the  EU  and  because  Lead  and  its 
compounds are already PS; Nitrofen was not considered further because it is only used as an 
intermediate in the production of Aminofen (CAS 14861-17-7) by only one producer and its 
use  as  a  PPP  in  the  EU  has  been  banned  since  1988.  Bis(tributyltin)oxide  (TBTO)  was  not 
considered further because Tributyltin compounds  are already PS. Coal tar pitch, distillates, 
pyrene  fraction  had  already  been  de-listed  from  the  monitoring-based  prioritisation  on  the 
grounds that PAHs are already PS. 

2.7. 

Other sources for identification of candidates for prioritisation  

Annex III to the EQSD identifies 13 substances that the Commission was required to review 
to  decide  whether  to  propose  them  for  inclusion  in  the  PS  list.  The  consideration  of  these 
substances is described in more detail in section 2.9. 

16 
17 

Salts and compounds of arsenic, cobalt and chromium are grouped into three groups. 
PCBs counted as 1 

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In addition, Member States and stakeholders in WG E were given the opportunity to identify 
and  provide  the  evidence  of  additional  substances  of  concern  that  were  causing  pollution 
problems,  likely  putting  at  risk  the  achievement  of  the  WFD  objectives,  and  that  were  not 
being  considered  through  any  of  the  prioritisation  routes.  The  following  substances  were 
proposed: 

• 

• 

• 

Germany proposed consideration of PFOS (already considered) 

Sweden proposed consideration of Irgarol (active substance Cybutryne) 

The  EEB,  supported  by  several  Member  States,  proposed  consideration  of  seven 
pharmaceuticals (including some with endocrine disruptive properties). 

Technical reports and literature references were provided. It was decided that detailed dossiers 
would be prepared for all of these. 

2.8. 

Approach to shortlisting 

2.8.1. 

Short-listing from the first candidate list 

The initial lists from the above prioritisation processes were amalgamated to produce a list of 
a  few  hundred  candidate  substances.  Further  short-listing  was  achieved  by  applying  of  a 
number  of  selective  criteria,  most  of  them  already  mentioned  under  the  individual  headings 
above. The short-listing was undertaken by the Sub-Group on Review. Efforts were made to 
consider all the available evidence when deciding on whether to take forward each substance.  

The selective criteria were, in summary, as follows:  

• 

• 

• 

• 

Substances ranking high or very high in the monitoring-based prioritisation for which 
the  ranking  was  due  to  data  from  less  than  3  countries  for  the  determinant  fraction 
were excluded because their selection was deemed non-representative. This led to the 
exclusion of 14 substances. 

No  further  investigation  was  undertaken  of  PPPs/biocides  that  had  been  authorised 
under the PPP legislation, but which had not been prioritised by any other process; or 
that  had  been  subject  to  a  non-inclusion  decision  under  Directive 91/414/EEC  or 
Directive 98/8/EC and did not rank high in any of the ranking exercises. This step led 
to the exclusion of 168 substances from further investigation. 

Substances  that  were  identified  due  to  assessments  under  the  existing  chemicals 
Regulation  (EEC)  No.793/93/EC,  were  generally  not  considered  further  if  the 
conclusion  (iii)  in  the  risk  assessment  report  regarding  risks  to  or  via  the  aquatic 
environment was reached for a local scenario or for only a few sites, and the scenario 
was not likely to be present in a significant number of river basins in the EU. Out of 
the  49  substances  with  conclusion  iii  for  the  aquatic  environment,  12  were  further 
investigated. 

Voluntary  risk  assessments  on  copper  and  on  PFOS,  for  which  the  results  showed 
conclusion (iii) for aquatic environment for some scenarios and uses, led to further 
consideration of those substances. 

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• 

• 

• 

No further investigation was undertaken of REACH SVHC for which the reason to 
propose this classification was their CMR properties alone, i.e. for which there was 
no  other  source  of  prioritisation  that  showed  that  exposure  through  water  was 
relevant.  This  meant  that  7  substances  that  had  been  identified  were  not  further 
investigated. 

No further investigation was undertaken of POPs where there was no other source of 
prioritisation. 

To arrive at a manageable list, the 10 highest-ranking substances from the monitoring 
and  modelling-based  prioritisation  processes  were  selected,  along  with 
the 
substances identified for further review from the risk assessment reports, as well as 
the  substances  indentified  from  the  other  sources  (PBTs,  SVHC,  POPs,  Annex  III 
lists). Some substances were selected based on more than one criterion. 

A  list  of  51  substances  for  preparation  of  dossiers  was  arrived  at  and  proposed  to  the  Sub-
Group on Review. To this list were added the 8 substances (Cybutryne and 7 pharmaceuticals) 
proposed as substances of concern to Member States, resulting in a shortlist of 59 substances 
(or groups of substances). 

Discussions within the Sub-Group at its meeting in January 2010 led to the elimination of 15 
of these substances or groups of substances for a range of reasons, e.g. because: 

• 

• 

• 

the risk assessment report identified risks to the aquatic environment, but sufficient 
risk  reduction  measures  had  been  implemented  and  there  was  evidence  they  were 
effective at local level. 

it appeared that risks to or via the aquatic environment were likely to be local only 
and best handled at national level. 

industry provided  new data on production volumes that led to lower ranking in the 
modelling-based prioritisation exercise. 

Heptachlor  and  Heptachlor  epoxide, 
isomers  of  HBCDD  and  17  alpha-
ethinylestradiol  and  17  alpha/beta  estradiol  were  considered  together  for  the  preparation  of 
dossiers, meaning that there was a short-list of 41 dossiers to be prepared for detailed review.  

two 

the 

2.8.2.  Preparation of substance dossiers and further short-listing 

For  the  41  short-listed  substances  or  groups  of  substances,  substance-specific  data  sheets 
(substance  dossiers)  were  prepared  to  facilitate  further  discussion  and  detailed  review.  A 
template for these was agreed by the Sub-Group. Member State volunteers or the Commission 
consultant  INERIS  were  tasked  with  acting  as  rapporteur  for  individual  dossiers,  and 
consulted  closely  with  associated  MS  and  stakeholders.  The  dossiers  collated  available 
information on the identity, regulation/legislation, properties, environmental occurrence, and 
toxicity of the substances. 

Once  the  dossiers  had  been  prepared,  the  Sub-Group  met  to  consider  which  substances  it 
should  recommend  for  EQS  derivation  and  inclusion  in  the  revised  PS  list.  A  summary 
document was prepared to structure and facilitate the discussions, including to highlight areas 

EN 

24 

   EN 

 
of  uncertainty  or  contention  including  points  that  had  been  flagged  by  rapporteurs  or 
associated MS/stakeholders. 

From the 41 substances or groups of substances, the Sub-Group arrived at a short-list of 20 
substances for further consideration, 16 of which they recommended for EQS derivation, 3 of 
which they considered required further information before a recommendation could be made, 
and one of which should be considered under the review of the existing PS. On the remaining 
substances they concluded that there was not sufficient evidence to take them forward in the 
current review. 

The  criteria  used  to  decide  on  each  substance  were  their  toxic  properties  and/or  available 
PEC/PNEC ratios. If a substance was either PBT/vPvB/ED/CMR and/or the PEC/PNEC ratio 
was  >=1,  it  was  generally  recommended  for  EQS  derivation,  unless  its  regulatory  situation 
suggested  this  might  or  would  not  be  necessary.  Conversely,  if  a  substance  was  not 
PBT/vPvB/ED/CMR and did not have a PEC/PNEC ratio >=1, it was generally put aside. 

More  information  was  judged  necessary  on  17  beta-estradiol,  ibuprofen  and  zinc  for  the 
following reasons.  

An industry study on the PNEC for 17 beta-estradiol was due in the near future that should be 
considered  before  concluding  that  the  PEC/PNEC  ratio  was  >1.  The  industry  study  was 
delivered  and  did  not  change  the  conclusion.  Therefore,  the  substance  was  finally  taken 
forward for EQS derivation. 

On Ibuprofen, the SCHER was asked whether a particular study that had been used as a key 
study to derive a tentative EQS could be used as sufficient basis for the EQS. The SCHER's 
response  was  that  other  supporting  studies  were  needed,  and  therefore  Ibuprofen  was  not 
proposed for prioritisation. 

On Zinc, further analysis  of the monitoring data (and risk ratios) was considered  necessary. 
This was performed and presented to the WG E. On this basis, a survey was performed among 
Member States experts that concluded that a large majority did not support the prioritisation 
of Zinc at this stage. The results of the assessment of the monitoring data were not conclusive 
because subject to a significant degree of uncertainty, arising from three main sources: 

• 

• 

• 

The  fact  that  most  of  the  monitoring  data  were  for  total  Zinc,  instead  of  dissolved 
Zinc as required for the risk assessment 

Monitoring  data  on  the  supporting  physico-chemical  parameters  needed  for  the 
estimation  of  bioavailability  were  not  available.  Default  parameters  had  to  be  used 
which introduced a significant degree of uncertainty. 

Information on natural background concentrations was scarce.  

On this basis, it was decided not to pursue the prioritisation of Zinc but to gather monitoring 
data  of  better  quality  for  the  purpose  of  risk  assessment  and  refine  the  analysis  in  a  future 
review of the list of priority substances. Although Zinc is not proposed for prioritisation, an 
EQS  was  derived  for  it  (and  assessed  by  the  SCHER)  which  could  be  used  by  MS  as  a 
national standard, thus improving harmonisation. 

EN 

25 

   EN 

 
EQS  fact  sheets  (EQS  dossiers)  based  on  the  substance  dossiers  were  prepared  for  19 
substances (the 17 indicated in Table 3 as "recommended for EQS derivation" plus Zinc and 
Ibuprofen, the latter only including a tentative EQS). The EQS derivation process is described 
in detail in section 3 of the present document. 

In the process of development of the EQS dossiers, discussions took place about the reliability 
of  the  monitoring  information  on  Cyanides.  Most  of  the  available  monitoring  data  were  for 
total Cyanides, whereas the toxicity data on the basis of which a PNEC had been derived were 
for  free  Cyanide  (the  form  listed  in  Annex  III  of  the  EQSD).  The  conclusion  of  the 
discussions was that free Cyanide would not be proposed for prioritisation in this review. As 
for Zinc, further review of free Cyanide would benefit from the collection of targeted high-
quality  monitoring  data.  For  this  reason,  both  substances  are  candidates  for  inclusion  in  the 
proposed watch list.  

Of the 19 substances shortlisted for EQS derivation, 16 appear in the proposal, although two 
are together, i.e. Dioxin-like PCBs are included with Dioxins. Non-dioxin-like PCBs are not 
included, on the grounds that there are insufficient data to reliably set an EQS.  

Table 3 summarises the outcome of the discussions on the 41 dossiers. 

Table 3: Outcome of expert discussion on the short-list of 41 dossiers 

Substance  

Recommended for EQS derivation 

17 alpha-ethinylestradiol (EE2) 

17 beta-estradiol (E2) 

Aclonifen 

Bifenox 

Cyanide – free (HCN and CN-) 

Cybutryne (Irgarol®) 

Cypermethrin 

Dichlorvos 

Diclofenac 

Dicofol 

Dioxin (2,3,7,8 - Tetrachlorodibenzo-p dioxin,TCDD) 

Heptachlor/Heptachlor epoxide 

1,2,5,6,9,10-Hexabromocyclododecane (HBCDD) 

Lead 

COM  

COM  

COM  

COM  

COM  

SE  

NL  

COM  

DE  

COM  

IT  

COM  

SE  

EN 

26 

   EN 

 
 
Substance  

1,3,5,7,9,11-Hexabromocyclododecane (HBCDD) 

Perfluorooctane sulfonic acid and its salts (PFOS) 

and perfluorooctane sulfonyl fluoride 

Polychlorinated biphenyls (PCBs) 

Quinoxyfen  

Terbutryn  

To be considered under the review of existing PS 

Diphenyl ether, octabromo (octaBDE) 

Not enough evidence to take forward at present 

Amino-methyl phosphonic acid (AMPA) 

Bentazone 

Bisphenol A (4,4'-isopropylidenediphenol) 

Carbamazepin 

Chlorothalonil 

Chromium trioxide 

Clarithromycin 

Cyclododecane  

Dichlofluanid 

Edetic acid (EDTA)  

Glyphosate 

Ibuprofen 

Mecoprop (MCPP) 

Musk xylene 

Omethoate 

Propiconazole 

Lead 

UK  

FR  

COM  

DE  

SE  

FR  

IT  

UK  

DE  

NL  

UK  

DE  

SE  

COM  

COM  

FR  

DE  

UK  

AT  

COM  

DE  

EN 

27 

   EN 

 
 
 
Substance  

Sulfamethoxazole 

Tolylfluanid 

Tri-allate 

Trichlorfon 

Zinc and its compounds 

2.9. 

Annex III of EQSD substances 

Lead 

DE  

FI  

UK  

FR  

UK  

All  13  Annex  III  substances  were  incorporated  in  the  modelling-based  prioritisation. 
Monitoring  data  was  also  available  for  a  number  of  the  substances  and  the  results  of  the 
monitoring-based  prioritisation  approach  for  those  are  presented  in  the  INERIS  Monitoring 
report  in  section  VIII.3.  Only  a  few  Annex  III  substances  were  not  already  proposed  for 
further consideration by other prioritisation processes. 

The  outcomes  of  the  individual  prioritisation  processes  and  the  conclusion  of  the  overall 
prioritisation process regarding each of the Annex III substances are presented in Table 4. 

Table 4: Conclusions of the individual and overall prioritisation processes regarding the Annex 
III substances  

CAS 

Substance 

Conclusion 

57-12-5  Cyanides (free) 

60-00-4  Edetic acid (EDTA) 

80-05-7  Bisphenol A  

(4,4'-isopropylidenediphenol) 

81-15-2  Musk xylene (5-tert-buthyl-2,4,5-

trinitro-m-xylene) 

Ranked very high in the monitoring based 
prioritisation. Risk ratio >1. Selected for 
EQS derivation but monitoring data 
largely for total rather than free cyanide, 
therefore not prioritised. Probable 
candidate for the proposed watch list.  

Risk assessment conclusion iii for aquatic 
environment, but evidence suggested risk 
ratio generally <1. Not selected for EQS 
derivation:  

2008 update of the risk assessment 
concluded no risk to aquatic environment. 
Outstanding controversy regarding effects 
on snails. Not selected, but evidence to be 
reviewed. 

Ranked high in modelling based 
prioritisation, PBT, SVHC. Insufficient 
evidence of a risk ratio>1. REACH Annex 
XIV listing will further reduce. Not 
selected. 

EN 

28 

   EN 

 
CAS 

Substance 

Conclusion 

115-32-
2 

Dicofol 

1066-
51-9 

Amino-methyl phosphonic acid  

(AMPA) 

1071-
83-6 

Glyphosate 

1336-
36-3 

Polychlorinated biphenyls (PCBs) 

1746-
01-6 

Dioxin (2,3,7,8 - Tetrachlorodibenzo-
p dioxin,TCDD) 

Ranked high in both monitoring and 
modelling based prioritisation, PBT, 
recommended as POP. Selected for EQS 
derivation. 

Identified in the INERIS report as 
potentially responsible for failures in the 
drinking water standard. Insufficient 
quantitative evidence of failure. Not 
selected. 

Identified in the INERIS report as 
potentially responsible for failures in the 
drinking water standard. Insufficient 
quantitative evidence of failure. Not 
selected. 

Ranked very high in the monitoring based 
prioritisation, PBT, POP. Selected for 
EQS derivation (but EQS derivation 
possible only for dioxin-like PCBs, along 
with dioxins; not enough data for non-
dioxin-like PCBs) 

Ranked very high in the monitoring based 
prioritisation, POP. Selected for EQS 
derivation. 

Perfluorooctane sulfonic acid and its 
salts (PFOS) and perfluorooctane 
sulfonyl fluoride 

Voluntary risk assessment identified risk 
to aquatic environment, PBT, POP. 
Selected for EQS derivation. 

1763-
23-1 

7085-
19-0 

Mecoprop (MCPP) 

Inclusion decision (PPP Directive Annex 
I) does not indicate the need to take 
measures to limit the risk to the aquatic 
environment. Risk ratio < 1. Concern re 
failures in drinking water not supported by 
sufficient quantitative evidence. Not 
selected for EQS derivation. 

Inclusion decision does not indicate the 
need to take measures to limit the risk to 
the aquatic environment. Risk ratio < 1. 
Concern re failures in drinking water not 
supported by sufficient quantitative 
evidence. Not selected for EQS derivation. 

25057-
89-0 

Bentazon 

EN 

29 

   EN 

 
CAS 

Substance 

Conclusion 

124495-
18-7 

Quinoxyfen 

Inclusion decision indicates the need to 
take measures to limit the risk to the 
aquatic environment. Isolated exceedance 
of tentative EQS but PBT properties. 
Selected for EQS derivation. 

Detailed dossiers were prepared for all Annex III substances because of the explicit obligation 
in the EQS Directive to review them. 

2.10.  Approach  to  substances  that  might  pose  a  specific  risk  to  drinking-water 

supplies 

In the monitoring-based ranking the PECs were compared with the drinking water standards. 
Raw  water  in  the  environment  is  not  expected  to  comply  with  drinking  water  standards  as 
water  is  treated  before  being  distributed,  and  therefore  some  pollutants  are  removed. 
However, the review tried to identify substances for which the ratio between the PEC and the 
drinking  water  standard  was  particularly  high,  i.e.  to  identify  substances  for  which  high 
treatment removal efficiency would be necessary, and which might thus cause failure of the 
drinking water standard at the tap. 

The  substances  ranking  high  in  this  approach  to  prioritisation,  and  the  estimated  treatment 
removal necessary to achieve the drinking water standard are presented in Table 5. 

Table 5: Conclusions of the monitoring-based ranking regarding substances that might pose a 
risk to drinking water supplies 

CAS 

Substance Name 

EQSD 
Annex 
III 
subst. 

Estimated removal 
efficiency needed 

7664-41-7  Ammonium compounds 

100-00-5 

1-Chloro-4-nitrobenzene 

99,96-99,97 

80-98 

1066-51-9  Aminomethylphosphonic acid (AMPA)  X 

89-92 

1071-83-6  Glyphosate (incl trimesium aka sulfosate) X 

69-84 

1698-60-8  Chloridazon 

34123-59-6  Isoproturon 

59-50-7 

4-Chloro-3-methylphenol 

75-01-4 

Chloroethylene 

7440-61-1  Uranium 

30-99,7 

49-76 

31-60 

86-99 

96-97 

EN 

30 

   EN 

 
 
 
 
 
 
 
 
It  should  be  noted  that  this  was  a  theoretical  exercise  as  no  information  was  available  on 
whether the high concentrations were found in water bodies  actually  used or intended to be 
used in the future for the abstraction of drinking water. For this reason, additional information 
was  requested  from  Member  States  and  the  drinking  water  industry,  in  particular  regarding 
whether  exceedances  of  the  drinking  water  standards  occur  that  are  linked  to  elevated 
concentrations of these or other substances in water bodies. The information received was not 
conclusive  in  terms  of  the  EU-wide  representativeness  of  the  problem.  Therefore,  no 
substance was proposed for prioritisation on this basis. 

3. 

ENVIRONMENTAL QUALITY STANDARDS (EQS) DERIVATION AND REVISION 

For  all  the  substances  proposed  for  listing  in  the  revised  PS  list  it  was  necessary  to  derive 
environmental quality standards (EQS) for inclusion in the amended EQS Directive. On  the 
basis of new evidence, the EQS for some existing substances had to be revised. 

The principles for setting EQSs are set out in Section 1.2.6 in Annex V of the WFD but the 
details necessary for practitioners to follow are lacking. The derivation and revision of EQS in 
the current review were done on the basis of updated guidance, produced as explained below. 
Although  there  is  no  formal  obligation  to  follow  the  guidance,  it  presents  best  practice  for 
EQS derivation. 

3.1. 

Technical  Guidance  on  Environmental  Quality  Standards  derivation  (TGD 
EQS) 

For  the  first  list  of  PS,  EQS  were  established  in  EQSD  on  the  basis  of  extensive  technical 
work  using  the  Manual  on  the  Methodological  Framework  to  derive  Environmental  Quality 
Standards for Priority Substances under the WFD prepared by the Fraunhofer Institute18. The 
work was supported by an Expert Advisory Forum established in 2001. For the present review 
it was necessary to update the guidance. The main elements of the update were identified on 
the basis of the 2004 opinion19 of the Scientific Committee on Toxicity, Ecotoxicity and the 
Environment  on  the  former  guidance  and  on  discussions  among  the  Commission,  Member 
States and stakeholder experts. 

An Expert Group (EG-EQS) under WG E co-chaired by the JRC and the UK was established 
to  update  the  guidance,  which  covers  all  receptors  (humans,  aquatic  life,  predators)  and  all 
media  (water,  sediments  and  biota)  that  might  be  put  at  risk  from  chemical  pollution.  The 
updated  guidance  builds  on  the  earlier  guidance  but  provides  more  detail  in  a  number  of 
important areas, e.g. how to deal with metals, and how to derive EQSs for sediment and biota. 
It  also  includes  more  detailed  guidance  on  other  aspects  of  standard  setting  that  were  not 
covered in the earlier document. 

18 
http://circa.europa.eu/Public/irc/env/wfd/library?l=/framework_directive/thematic_documents/priority_substance

Lepper (2005) 

19 

EN 

s/supporting_background/manual_methodology/_EN_1.0_&a=d  
Opinion of the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) on “The 
setting  of  the  Environmental  Quality  Standards  for  the  Priority  Substances  included  in  Annex  X  of 
Directive  20006/60/EC  in  accordance  with  Article  16  thereof”.  Adopted  by  CSTEE  during  the  43rd 
plenary 
2004. 
(http://ec.europa.eu/health/archive/ph_risk/committees/sct/documents/out230_en.pdf ) 

meeting 

May 

28 

of 

31 

   EN 

 
                                                 
It addresses all the points raised by CSTEE, not only regarding metals, sediments and biota, 
but also for example regarding the derivation of EQSs for transitional and coastal waters, the 
reliability  and  relevancy  of  the  data  used  to  derive  EQS,  the  use  of  higher  tier  assessment 
methods and data such as Species Sensitivity Distributions (SSDs) and mesocosm study data 
in  the  derivation  of  short-term  exposure  standards,  i.e.  MAC-EQS,  consideration  of 
uncertainties, and the objective of protecting human health. 

EG-EQS  also  sought  to  address  technical  issues  highlighted  in  a  paper  by  Bonnomet  and 
Alvarez  to  the  Expert  Advisory  Forum  (8)  in  2006,  and  to  incorporate  recent  scientific 
thinking  in  the  development  of  environmental  standards  e.g.  those  highlighted  in  a  SETAC 
technical workshop held in the UK in 2006. 

Since the guidance on EQS setting in Annex V of the WFD refers to guidance developed for 
Existing Substances and Biocides, part of the brief to the EG-EQS was to be consistent, as far 
as  practicable,  with  guidance  developed  for  REACH.  The  updated  guidance  highlights  the 
role  of  existing  risk  assessments,  e.g.  those  conducted  under  the  PPP  legislation,  in  setting 
EQSs.  

The  updated  guidance  was  submitted  to  the  Scientific  Committee  on  Health  and 
Environmental  Risks  (SCHER)  for  its  opinion.  The  SCHER  was  largely  supportive  of  the 
guidance,  including  of  its  handling  of  metal  bioavailability.  The  TGD-EQS  was  slightly 
revised  in  response  to  specific  comments,  but  the  changes  in  the  guidance  did  not  affect 
significantly the methodology for EQS setting, and consequently did not affect the EQS that 
were  already  being  developed  on  the  basis  of  the  draft  updated  guidance.  A  number  of 
observations  by  the  SCHER  will  be  addressed  in  the  longer  term  in  future  revisions  of  the 
guidance. 

The final updated TGD-EQS was endorsed by the Water Directors of the Member States in 
May 2011. 

3.2. 

Derivation of EQS for Proposed Priority Substances 

As  indicated  above,  EQS  fact  sheets  (EQS  dossiers)  were  prepared  for  18  substances  or 
groups of substances (the 19 shortlisted, excluding ibuprofen, for which only a tentative EQS 
was developed as a basis for the consultation with SCHER). 

The  rapporteurs  were  in  some  cases  different  from  those  which  prepared  the  original 
substance dossiers. The template was the same as that for the substance dossiers; the sections 
related to the EQS were revised or completed for the first time.  

Information extracted from grey literature was reported in the EQS dossiers where necessary 
and/or  relevant  but  European  and  international  peer-reviewed  sources  of  information  were 
given  priority  (e.g.  European  risk  assessments  for  existing  substances,  PPPs  and  biocides, 
PBT evaluations, US-EPA assessments). 

The  EQS  dossiers  were  considered  initially  by  the  associated  Member  States  and 
stakeholders, then by the Sub-Group on Review as a whole. In most cases agreement on the 
proposed  EQS  was  reached.  However,  in  some  cases,  divergent  views  remained.  The  EQS 
dossiers  were  submitted  to  the  SCHER  for  its  opinion,  in  particular  as  to  whether  the  EQS 
have been correctly and appropriately derived, in the light of the available information and the 

EN 

32 

   EN 

 
TGD-EQS, and whether the most critical EQS (in terms of impact on environment/health) has 
been correctly identified. 

Divergent  views  in  the  Sub-Group  were  highlighted  in  the  requests  to  the  SCHER.  As 
explained  above,  in  the  case  of  ibuprofen,  a  critical  but  disputed  study  rather  than  an  EQS 
dossier  was  submitted  for  an  opinion  on  its  relevance  for  EQS  setting.  The  dossier  for  the 
non-dioxin-like  PCBs  was  not  submitted  because  there  were  not  enough  data  to  reliably 
derive an EQS. 

In response to the SCHER opinion on aclonifen, the decision was taken not to designate it as a 
PHS,  despite  views  to  the  contrary  from  the  Sub-Group.  The  SCHER's  comments  on  the 
cypermethrin dossier led to a check of the cited data and a number of corrections to citations 
but not to any change in the EQS, since the errors identified by the SCHER were not critical 
to the conclusions.  The dicofol dossier was reviewed and some corrections made leading to 
an  approximately  4-fold  increase  in  the  biota  standard  and  corresponding  (back-calculated) 
water EQS. In the EE2 and E2 dossiers, the marine annual average quality standards (AA-QS) 
were doubled as a result of adjusting the additional assessment factor from 10 to 5. Additional 
information  and/or  explanation  was  added  to  a  number  of  the  other  EQS  dossiers,  most 
notably  the  dioxins  dossier,  but  no  other  changes  were  made  to  EQS.  For  diclofenac, 
SCHER's opinion suggested that until there is greater certainty about the magnitude of a biota 
EQS,  the  water  EQS  should  be  considered  the  critical  EQS;  this  will  have  to  be  reviewed. 
Similarly,  a  better  acute  toxicity  dataset  should  in  due  course  allow  a  Maximum  Allowable 
Concentration (MAC) to be set. 

In most of the dossiers, explanation has been added regarding the application of an additional 
assessment  factor  for  the  marine  compared  with  the  freshwater  EQS.  The  additional 
assessment  factors  (not  always  10)  have  been  applied  according  to  the  revised  TGD-EQS 
referred to above.  The guidance, which is consistent with the approach under REACH, states 
that: the assessment factors provided for deriving the marine water QS are higher than those 
used  for  freshwater  and  that  "this  is  justified  by  the  need  to  account  for  the  additional 
uncertainties  associated  with  extrapolation  for  the  marine  ecosystem,  especially  the  general 
under-representation  in  the  experimental  dataset  of  specific  marine  key  taxa  and  possibly  a 
greater  species  diversity".  The  guidance  provides  criteria  for  diverging  from  the  provided 
default assessment factors.  These criteria were used to determine the assessment factors and 
therefore the marine water QS for the substances in the PS review on a case-by-case basis. 

3.3. 

Revision of EQS for Existing Priority Substances 

Members of the Working Group E (WG E) were asked to indicate whether the EQS for any 
existing PS should be revised on the basis of new scientific information, and to comment on 
the need for standards in environmental compartments other than those for which they were 
already available. In addition, a systematic check was made of any updates to European risk 
assessment reports on existing PS (under the chemicals, biocides and PPP legislation). 

On the basis of the findings, it was decided that the EQS for following substances should be 
reviewed. 

Table 6: Rationale for reviewing EQS of existing PS 

Existing substance 

Rationale for reviewing EQS 

EN 

33 

   EN 

 
Existing substance 

Rationale for reviewing EQS 

Anthracene, Fluoranthene, 
Naphthalene, PAH 5-6 rings 

New information (Final EU RAR for Coal Tar Pitch, 
High Temperature, 2008) 

Benzene 

New information (Final EU RAR 2008) and Member 
State concern about carcinogenicity 

Polybrominated diphenyl ethers 

To include octaBDE (prioritised in the prioritisation 
process) 

Lead 

Mercury 

Nickel 

New information (EU VRAR 2008, SCHER review of 
VRAR 2009, first draft of Chemical Safety Report for 
REACH registration) and need to consider 
bioavailability 

Concern about the biota matrix to be monitored 

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

The EQS for most of these substances were therefore revised according to the updated TGD-
EQS, and the dossiers were submitted to the SCHER for its opinion.  

For  the  substances  reviewed  in  the  light  of  the  final  RAR  for  Coal  Tar  Pitch,  the  new 
information led to the conclusion that for fluoranthene and four of the PAHs (i.e. excluding 
benzo(g,h,i)perylene,  the  critical  matrix  was  biota.  The  Sub-Group  proposed,  for  the  four 
PAHs,  use  of  the  established  food  standard  based  on  the  toxicity  of  benzo(a)pyrene.  This 
would  also  cover  the  risk  from  the  non-carcinogenic  PAH.  For  polyBDEs  a  biota  standard 
was  also  proposed.  In  all  these  cases,  calculation  of  a  corresponding  water  standard  led  to 
values  lower  (in  some  cases  much  lower)  than  the  existing  water  standard.  For  this  reason, 
and  because  the  back  calculation  is  subject  to  some  uncertainty,  use  of  the  biota  standard 
appears appropriate. 

The  SCHER's  comments  led  to  review  of  the  above  EQS  dossiers  and  some  changes  were 
made.    In  the  anthracene  and  fluoranthene  dossiers,  the  AA-QS  for  marine  sediment  were 
adjusted  by  eliminating  the  additional  assessment  factor  of  5.    In  the  naphthalene  dossier, 
explanation  was  added  for  the  choice  of  methodology  and  the  retention  of  different 
assessment factors for the freshwater and marine sediment AA-QS. In the polyBDEs dossier, 
explanation was added for the choice of indicator congeners. 

For  benzene,  industry  brought  new  epidemiological  and  exposure  information  to  the  Sub-
Group on Review, and it was concluded that the review would not be pursued further at this 
stage as there was no clear case for it. 

For  lead  and  nickel,  the  revision  led  to  standards  for  the  bioavailable  metal.  In  the  2006 
Commission  proposal,  these  two  standards  were  highlighted  as  preliminary,  as  the  risk 
assessments were at the time not finalised. The SCHER opinion on the lead dossier prompted 
the  addition  of  some  clarifications,  and  the  selection  of  an  assessment  factor  of  4  for  the 

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34 

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freshwater and marine sediment EQS, allowing presentation of a single value for each EQS 
rather than a range. The SCHER opinion on the nickel EQS dossier prompted additional in-
depth and independent statistical analysis of some higher-tier data. There was a difference of 
opinion among the experts involved. 

For mercury, a review of a large number of studies on secondary poisoning was undertaken 
by INERIS and made available to the SG-R. This work supports the use of fish as the main 
biota matrix for monitoring. 

For 11 other substances, relevant updated risk assessments were identified, but a closer review 
led to the conclusion that revision of the EQS was not necessary at this stage. 

4. 

PRIORITY HAZARDOUS SUBSTANCES (PHS) STATUS 

4.1. 

Definition and criteria 

"Hazardous  substances"  are  defined  in  the  WFD  as  substances  or  groups  of  substances  that 
are  toxic,  persistent  and  liable  to  bio-accumulate,  and  other  substances  or  groups  of 
substances  which  give  rise  to  an  equivalent  level  of  concern.  Article  16  of  the  WFD 
determines  that  for  Priority  Hazardous  Substances  (PHS)  measures  should  be  aimed  at  the 
cessation or phasing-out of discharges and emissions and losses to the aquatic environment. 

For the first list of priority substances (PS), the classification of PS as PHS was based largely 
on the PBT criteria listed in the Technical Guidance Document on Risk Assessment (ECB)20 
and in the proposal for the REACH Regulation. The classification of the 33 PS was done in 
two stages, i.e. 11 were classified definitely as PHS already in Decision 2455/2001/EC, but 14 
were  classified  as  possible  PHS,  subject  to  review  –  see  Commission  Working  Document 
ENV 191000/01 final21. The procedure proposed was to group the PS according to their level 
of concern, taking particular account of their level of hazard. Reference was made to hazard 
classifications under other legislation, e.g. OSPAR Strategy, Council Directive 67/548/EEC, 
POPs Protocol under the UN-ECE CLRTAP, EU-RARs under Regulation (EEC) No. 793/93 
and  Council  Directive  76/464/EEC  and  its  five  daughter  directives.  After  grouping  the 
substances,  additional  considerations  were  taken  into  account,  including  other  relevant 
Community  legislation  or  relevant  international  agreements,  the  production  and  use  of  the 
substance and the suspected endocrine disrupting potential of the substance. 

In  2006,  for  the  proposal  on  the  EQS  Directive,  a  further  document  setting  out  a  list  of 
characteristics that would justify PHS classification, including characteristics giving rise to an 
equivalent  level  of  concern,  was  developed22.  For  14  PS  under  review  at  that  stage,  it  was 

20 

21 
22 

European Commission Technical Guidance Document in support of Commission Directive 93/67/EEC 
on  Risk  Assessment  for  new  notified  substances,  Commission  Regulation  (EC)  No  1488/94  on  Risk 
Assessment  for  existing  substances  and  Directive  98/8/EC  of  the  European  Parliament  and  of  the 
Council  concerning  the  placing  of  biocidal  products  on  the  market,  Part  I  and  Part  II.  European 
Communities, 2003. 
http://ec.europa.eu/environment/water/water-dangersub/pdf/wd_env_191000_01_final.pdf  
COM  (2006)  397  and  COM  (2006)  398  Informal  Background  Document  Identification  of  Priority 
Annex) 
Hazardous 
http://circa.europa.eu/Public/irc/env/wfd/library?l=/framework_directive/thematic_documents/priority_
substances/supporting_background/identificationpdf/_EN_1.0_&a=d 

Substances 

(including 

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35 

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agreed  to  assess  the  aspect  of  “equivalent  concern”  on  a  case-by-case  basis  with  the 
application  of  expert  judgement  and  by  ensuring,  wherever  possible,  coherence  with  other 
relevant Community legislation. Decisions were  made  to  confirm  9  of  the  14  tentative  PHS 
designations,  such  that  20  PS  were  finally  designated  as  PHS.  The  criteria  for  equivalent 
concern were: 

a) Very Persistent, Very Bioaccumulative (vPvB)-criteria; 

b) Persistent Organic Pollutants (POP) (cf. Stockholm Convention); 

c) Carcinogenic, mutagenic and toxic for reproduction (CMR); 

d) Very Persistent, Very Toxic (vPvT) for substances with a high mobility; 

e) Targeted risk assessments showing a particular risk for parts of the aquatic environment (in 
particular marine and groundwater). 

Since that 2006 review, the REACH Regulation has become operational. The PBT criteria are 
laid down in Annex XIII, and there is a growing list of Substances of Very High Concern - 
SVHC as  defined  in  Article  57  of  REACH  -   which  may  be  included  in  Annex  XIV  of  the 
Regulation and thus become subject to authorisation. 

It is reasonable, in view of Recital 28 of the EQSD and Article 2 (paragraphs 29 and 30) of 
the  WFD, to  harmonise  the  WFD  approach  with  the  approach  taken  under  REACH,  and 
therefore to use, as bases for identifying PHS, the criteria in REACH Annex XIII and Article 
57  relating  to  PBTs  and  substances  posing  an  equivalent  level  of  concern.  However,  not 
all SVHC under REACH necessarily qualify as PHS, since not all are relevant to the aquatic 
environment,  nor  should  the  REACH  criteria  be  considered  exclusive,  since  REACH  is  not 
the  main  legislation  for  all  chemicals  (for  example  substances  used  in  Plant  Protection 
Products  and  pharmaceutical  products  are  exempted  from  REACH  authorisation),  and  its 
concerns do not necessarily encompass all the concerns arising under the WFD.  

Although  substances  having  endocrine  disrupting  properties  are  covered  in  Article  57(f)  of 
REACH,  the  Commission  is  currently  developing  criteria  to  assess  endocrine  disrupting 
substances  and  their  properties,  and  for  this  reason,  no  attempt  is  being  made  during  this 
review to classify  proposed PS as PHS on the  basis of their endocrine disrupting properties 
alone. The outcome of the Commission work is expected in 2013. 

4.2. 

Review 

4.2.1.  Changes to existing Priority Substances 

A questionnaire to members of Working Group E regarding whether there was new evidence 
that  would  provide  grounds  to  reclassify  some  existing  PS  as  PHS  led  to  a  number  of 
suggestions. The technical grounds given were assessed by the Sub-Group on Review of the 
Priority Substances List (SG-R). 

http://circa.europa.eu/Public/irc/env/wfd/library?l=/framework_directive/thematic_documents/priority_substance

s/supporting_background/identification_annexpdf/_EN_1.0_&a=d 

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Of the five existing PS reviewed, two are proposed for possible reclassification to PHS, i.e. 
DEHP and Trifluralin. 

Tables 7(a)-(e) summarise the evidence considered and the conclusions of the present review. 

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37 

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Table 7(a) PS No.12: Di (2-ethylhexyl)-phthalate (DEHP) 

Conclusion 
of previous 
review 

PBT criteria not met, though some borderline 

Widespread in environment, therefore humans exposed through whole lifetime 

These points might justify “equivalent level of concern” but EAF judged that there 
was not sufficient evidence of concern 

Some MS in favour of PHS status but no additional evidence provided 

Technical 
grounds for 
PHS status 

Reprotoxic. Cat IB in Annex VI Table 3.1 (harmonised classification and labelling of 
hazardous substances) of Regulation (EC) 1272/2008 (CLP) based on criteria in 
Annex I of the Regulation; Cat 2 in Annex VI Table 3.2 based on criteria in Annex 
VI of Directive 67/548/EEC. 

DEHP bioaccumulates in aquatic organisms. The BCF is =<2700, being 840 in fish 
and 2500 in mussels. The EU risk assessment (RAR, 2008, 
http://esis.jrc.ec.europa.eu/doc/existing-
chemicals/risk_assessment/REPORT/dehpreport042.pdf) suggests need to limit risk 
of secondary poisoning in relation to food chains based on aquatic organisms, 
especially mussels, and a need to limit the risks to children in relation to exposure via 
the environment (taking account of existing risk reduction measures). 

Identified as substance of very high concern (SVHC) under REACH and listed in 
Annex XIV due to toxicity for reproduction, see: 
http://echa.europa.eu/doc/authorisation/annex_xiv_rec/subs_spec_background_docs/d
ehp.pdf#search="DEHP" and http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:044:0002:0006:EN:PDF  

Detected in sediment and biota in remote areas in southern Norway: 
http://www.klif.no/publikasjoner/2284/ta2284.pdf page 63.  

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38 

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Technical 
arguments 
against PHS 
status 

(CEFIC - 
ECPI) 

Not PBT (RAR for under Regulation (EEC) No 793/93) 

Not PBT and not a risk for the marine environment at present exposure (OSPAR 
2008) 

Reprotoxicity under Directive 67/548/EEC in place since 2001; not supported by 
Caunter et al 2004 study reviewed in RAR 

In REACH candidate list because of existing toxicity classification; all evidence will 
be reviewed; recent papers indicate that the exposure of children is similar to that of 
adults and the Margin of Safety means there is no need for concern 

Site-specific concentrations show no secondary poisoning risk 

Detection in sediment and biota at remote locations not a reason for PHS status 
(concentrations not a risk to aquatic organisms) 

COM WG on CLP concluded not dangerous to the environment 

Environmental concentrations are decreasing 

Biodilution (rather than biomagnification) occurs up the food chain. 

Conclusions 
on the 
technical 
grounds 

Appropriate to list as PHS given conclusions in the RAR and the inclusion of DEHP 
in Annex XIV of REACH (SVHC). The RAR (post-dating the COM WG on CLP) 
concluded that there was no concern for aquatic species exposed via the water phase, 
but that there was a need to limit the risk of secondary poisoning and the risks to 
children in relation to exposure via the environment (taking account of existing risk 
reduction measures).  

Table 7(b) PS No. 20: Lead and its compounds 

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39 

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Conclusion 
of previous 
review 

PBT assessment of metals difficult; in particular, P assessment not possible 

Comparison with Hg and Ni led to conclusion that there was not sufficient evidence 
that Pb posed an equivalent level of concern  

Technical 
grounds for 
PHS status 

Repr. 1A (H360: May damage fertility or the unborn child.) according to CLP for Pb 
compounds, some exceptions; and according to REACH self-classification for Pb 
metal powder, inorganic Pb compounds 

Carc 2 – according to REACH self classification for inorganic Pb compounds; IARC 
Carc 2A - on basis of 2B plus limited epidemiological evidence  

Damaging to IQ – threshold level for neurodevelopmental effects cannot be identified 
(methodological limitations?) 

Recent SCHER opinion on lead in drinking water23  states that it sees no scientific 
basis for an increase in the drinking water standard for lead; a decrease in lead intake 
would reduce risk. 

Not PBT 

Pb metal and inorganic Pb not expected to be mutagenic under normal use and 
handling. (Note: data inconsistent, questions re relevance of exposure 
route/concentrations to in vivo circumstances)  

Insufficient epidemiological evidence to indicate that inorganic lead or lead 
compounds pose human cancer risk at most tissue sites studied. 

Conclusion that exposure of humans via surface waters minor in comparison with 
other routes, therefore not PHS despite intrinsic properties. 

Technical 
arguments 
against PHS 
status 

(ILA-E) 

Conclusions 
on the 
technical 
grounds 

Table 7(c) PS No. 26: Octylphenol 

Fulfils P and T criteria, not B 

No equivalent level of concern identified 

Endocrine disruptive and same level of concern as nonylphenol (already PHS). 

Conclusion 
of previous 
review 

Technical 
grounds for 
PHS status 

23 

http://ec.europa.eu/health/scientific_committees/environmental_risks/docs/scher_o_128.pdf 

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40 

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OP is an intermediate, not remobilised from the final resin 

Current EQS (0.1 μg/l) conservative, cf REACH PNEC (0.632 μg/l) 

Environmental concentrations low; few exceedances of EQS; case-by-case 
management appropriate 

Reprotox study in rats (ref to be added) – no evidence of effects 

EQS is protective for endocrine effects (literature review) 

Presence of OP in NP not higher than approx 1% 

(No conclusion for the moment: ED criteria being developed by COM.) 

Technical 
arguments 
against PHS 
status 

(CEFIC - 
CEPAD) 

Conclusions 
on the 
technical 
grounds 

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41 

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Table 7(d) PS No. 31: Trichloro-benzenes 

Lowest NOECs > T threshold, but uncertainty re mammalian toxicity 

Potential for long-range transport 

List I substance under Dir 76/464/EEC 

RAR under Reg (EEC) No.793/93 identified risks 

BUT, the Commission recommended that TCBs not be designated as PHS until the 
criteria for establishing 'an equivalent level of concern' were agreed and it could be 
demonstrated that the criteria are met by this substance. 

PBT (Identified as PBT by the Technical Committee New and Existing Substances 
(TC NES) Subgroup on identification of PBT and vPvB Substances, EC). 

Proposed for investigation as POPs.  

Does not satisfy PBT criteria. (van Wijk D et al (2006) 1,2,4-Trichlorobenzene 
marine risk assessment with special emphasis on the Osparcom region North Sea. 
Chemosphere 62, 1294-1310) 

Not placed on REACH candidate list in 2010 because not identified as PBT  

Existing restrictions under Directive 2005/59/EC and registration only as 
intermediate under REACH mean little possibility of emission to aquatic environment

Not a PBT; POP proposal apparently withdrawn. Not PHS. 

Conclusion 
of previous 
review 

Technical 
grounds for 
PHS status 

Technical 
arguments 
against PHS 
status 

(CEFIC - 
EuroChlor) 

Conclusions 
on the 
technical 
grounds 

Table 7(e) PS No. 33: Trifluralin 

Conclusion 
of previous 
review 

Technical 
grounds for 
PHS status 

Fulfils B and T criteria but not P 

No equivalent level of concern identified 

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.) 

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42 

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Technical 
arguments 
against PHS 
status 

(Dow Agro-
Sciences) 

Conclusions 
on the 
technical 
grounds 

PBT criteria not fulfilled in any single environmental compartment. 

CLRTAP process ongoing; conclusions on persistence should not be drawn until 
decision made. 

The Task Force (June 2010) "was not able to reach a consensus on trifluralin as a 
POP in the context of the Protocol…". At the Executive Board (December 2010) "it 
was suggested that the Working Group on Strategies and Review should consider any new scientific 
information with regard to trifluralin and/or PCA/PCP that might be submitted in time for its forty-ninth 
session in September 2011" 

PBT criteria met even if POP designation not confirmed. (P criterion for PBT is less 
stringent than for POP, i.e. 120d cf 180d in soil; PBT criteria do not have to be met in 
single compartment.). PHS. 

4.2.2.  Proposed new Priority Hazardous Substances 

Table 8 summarises the conclusions of the present review. 

Table 8: Proposed PHS 

Substance 

Rationale for PHS status 

Dicofol 

CLRTAP  Working  Group  on  Strategies  and  Review  (Sept 
2010) has recommended listing in POP protocol. 

Dioxins and Dioxin-like PCBs  Fulfils PBT criteria. 

Suspected to be endocrine disruptive. 

Several  congeners  show  endocrine  disruptive  properties. 
One congener carcinogenic. 

PFOS 

PBT; POP since August 2010. 

Reprotoxic (Cat 2) 

HBCDD 

CLRTAP  Working  Group  on  Strategies  and  Review  (Sept 
2010) has recommended listing in POP protocol 

Heptachlor/Heptachlor epoxide  Fulfils PBT criteria. 

Suspected to be endocrine disruptive. 

IARC Group 2b – possibly carcinogenic to humans. 

Quinoxyfen 

Fulfils PBT criteria. 

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43 

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5. 

TECHNICAL BACKGROUND DOCUMENTS  

Technical background documents listed below are available at: 

http://circa.europa.eu/Public/irc/env/wfd/library?l=/framework_directive/thematic_documents
/priority_substances/supporting_substances 

The following documents are included: 

• 

Results of the monitoring-based prioritisation: 

INERIS-International  Office  for  Water.  Implementation  of  requirements  on  Priority 
(contract 
substances  within 
07010401/2008/508122/ADA/D2).  Prioritisation 
ranking 
(September 2009).  

the  Water  Framework  Directive 
process:  Monitoring-based 

the  Context  of 

• 

Results of the modelling-based prioritisation: 

K.  Daginnus,  S.  Gottardo,  A.  Mostrag-Szlichtyng,  H.  Wilkinson,  P.  Whitehouse,  A.  Paya-
Pérez  and  J.  M.  Zaldívar  (2010).  A  modelling  approach  for  the  prioritisation  of  chemicals 
under the Water Framework Directive. JRC Scientific and Technical Report EUR 24292 EN. 
http://publications.jrc.ec.europa.eu/repository/bitstream/111111111/13548/1/prioritization_eu
r_february10_final.pdf  

• 

Methodology for deriving EQS 

Common  Implementation  Strategy  for  the  Water  Framework  Directive  (2011).  Guidance 
document No 27. Technical Guidance for Deriving Environmental Quality Standards.  

• 

EQS dossiers 

23 substance specific dossiers summarising the derivation of the EQS. 

• 

SCHER opinions on the Technical Guidance document and the EQS dossiers 

the 

The scientific opinion on the Technical Guidance for Deriving EQS and 24 scientific opinions 
on 
at: 
http://ec.europa.eu/health/scientific_committees/environmental_risks/opinions/index_en.htm#
id10  

substances 

individual 

available 

EQS 

the 

are 

for 

• 

Source screening and measures sheets 

Updated  source  screening  and  measures  screening  sheets  for  the  existing  33  PS  and  for  19 
candidate PS 

• 

Study supporting the impact assessment 

Entec  UK  Ltd.  Technical  Support  for  the  Impact  Assessment  of  the  Review  of  Priority 
Substances under Directive 2000/60/EC (Contract 070307/2009/547548/SER/D1):  

Interim report (methodology) (November 2010) 

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44 

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29 substance-specific impact reports (April 2011) 

Final report (including high-level analysis) (June 2011) 

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