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
Date: 2012-01-31
Institutions: European Commission
Subjects: dangerous substance, environmental impact, environmental monitoring, environmental standard, water analysis, water pollutant, water treatment

EUROPEAN COMMISSION 

Brussels, 31.1.2012  
COM(2011) 875 final 

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 

(Text with EEA relevance) 

{SEC(2011) 1544 final} 

 
 
 
 
 
 
TABLE OF CONTENTS 

1. 

2. 

3. 

3.1. 

3.2. 

3.3. 

3.4. 

3.5. 

3.6. 

4. 

Legal background......................................................................................................... 1 

Summary of the technical process and consultation .................................................... 1 

Summary of the outcome of the review ....................................................................... 1 

Introduction .................................................................................................................. 1 

Review of existing priority substances ........................................................................ 1 

Identification of new priority substances ..................................................................... 1 

Review of substances in Annex III to Directive 2008/105/EC .................................... 1 

Identification of control measures at EU level............................................................. 1 

Other outcomes ............................................................................................................ 1 

Outlook for future reviews of Annex X to Directive 2000/60/EC............................... 1 

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1. 

LEGAL BACKGROUND 

Article  16(4)  of  the  Water  Framework  Directive  (WFD,  2000/60/EC)1  requires  the 
Commission to review regularly its Annex X which contains the list of priority substances in 
the field of water policy, identified among those posing a significant risk to or via the aquatic 
environment. Article 16(2) sets out the criteria for the identification of priority substances. In 
addition,  Article  16(3)  requires the  Commission  to  identify  priority  hazardous  substances,  a 
subset of priority substances characterised by their persistence, bioaccumulation and toxicity 
or equivalent level of concern.  

Article 16(6) requires the Commission to put forward proposals of controls for the progressive 
reduction of discharges, emissions and losses of priority substances and for the cessation or 
phase-out of emissions, discharges and losses of priority hazardous substances. It also sets out 
a time limit of 20 years to achieve the cessation or phase-out, from the date of adoption of the 
controls. 

The  existing  list  of  33  priority  substances  was  established  by  Decision  No  2455/2001/EC2, 
and amended by Directive 2008/105/EC3 (EQSD). The latter also established environmental 
quality standards (EQS) for all the 33 priority substances and for 8 other pollutants that were 
already regulated at EU level under existing legislation.  

Article 8 of EQSD requires the Commission to consider, within the framework of the review 
of WFD Annex X, inter alia the substances set out in Annex III to that Directive for possible 
identification as priority substances or priority hazardous substances. The Commission should 
report the outcome of its review to the European Parliament and to the Council by 2011 and 
accompany  the  report,  if  appropriate,  with  relevant  proposals,  in  particular  proposals  to 
identify new priority substances or priority hazardous substances or to identify certain priority 
substances as priority hazardous substances and to set corresponding EQS for surface water, 
sediment or biota, as appropriate. 

This report is the Commission report required by Article 8 of the EQSD. It is accompanied by 
a Commission proposal for a Directive amending Directives 2000/60/EC and 2008/105/EC as 
regards priority substances in the field of water policy. 

2. 

SUMMARY OF THE TECHNICAL PROCESS AND CONSULTATION 

The  technical  work  for  the  review  was  led  by  DG  ENV  and  the  JRC  and  carried  out  by  a 
range of experts. These included members of the Chemical Aspects Working Group E (WG 
E) under the WFD Common Implementation Strategy (CIS)4, and consultants contracted by 
the Commission. The membership of WG E consists of Commission DGs, Member States and 

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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 
Decision  No  2455/2001/EC  of  the  European  Parliament  and  of  the  Council  of  20  November  2001 
establishing  the  list  of  priority  substances  in  the  field  of  water  policy.  OJ  L  331,  15.12.2001,  p. 1. 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:331:0001:0005:EN:PDF 
Directive  2008/105/EC  of  the  European  Parliament  and  of  the  Council  of  16  December  2008  on 
environmental quality standards in the field of water policy. OJ L 348, 24.12.2008, p. 84. 
http://ec.europa.eu/environment/water/water-framework/objectives/implementation_en.htm  

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stakeholder  organisations  including  a  range  of  European  industry  associations,  NGOs  and 
intergovernmental organisations.  

WG E contributed significantly to the review by supporting the collection of data (including 
monitoring  and  hazard  data),  the  prioritisation  process  for  identifying  new  substances,  the 
update  of  the  Technical  Guidance  Document  on  EQS  setting,  and  the  derivation  of  EQS.  It 
also  supported  the  review  of  the  existing  priority  substances  (EQS  and  priority  hazardous 
status).  

The  draft  EQS  were  submitted  to  the  Scientific  Committee  on  Health  and  Environmental 
Risks (SCHER)5 for its opinion.  

The  review  was  completed  with  an  impact  assessment  supported  by  an  Impact  Assessment 
Steering  Group  made  up  of  Commission  services  and  by  a  consultancy  contract.  The 
contractors drafted individual substance impacts reports taking into account the conclusions of 
the technical work and additional inputs from WG E and other stakeholders not represented in 
that WG.  

The Impact Assessment Board discussed the Impact Assessment report at its meeting on 22 
June  2011.  The  comments  made  by  the  Board  have  been  addressed  in  the  final  Impact 
Assessment report SEC(2011)1545. 

3. 

SUMMARY OF THE OUTCOME OF THE REVIEW 

3.1. 

Introduction 

The review of Annex X to Directive 2000/60/EC has been undertaken in accordance with the 
requirements  of  the  WFD.  The  technical  details  of  the  review  are  explained  in  the 
accompanying Commission Staff Working Paper SEC(2011)1544. 

3.2. 

Review of existing priority substances 

As  a  consequence  of  the  technical  review  and  taking  into  account  newly  available 
information, the following changes are proposed to existing EQS: 

• 

• 

• 

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the water EQS of the following existing priority substances are proposed for update: 
Anthracene, 
hydrocarbons, 
Naphthalene, 
Polybrominated diphenyl ethers, Lead and Nickel.  

Fluoranthene, 

Polyaromatic 

biota  EQS  have  been  developed  and  are  proposed  for  Fluoranthene,  Polyaromatic 
hydrocarbons  and  Polybrominated  diphenyl  ethers,  because  due  to  their  properties 
these substances are more easily and reliably measurable in this matrix.  

existing  biota  EQS  for  Hexachlorobenzene,  Hexachlorobutadiene  and  Mercury  are 
maintained,  but  the  water  EQS  and  footnote  9  in  Part  A  of  Annex  I  to  Directive 
2008/105/EC are deleted because those EQS do not afford adequate protection. 

The SCHER is one of the Scientific Committees providing the Commission with independent advice. It 
is 
at 
http://ec.europa.eu/health/scientific_committees/environmental_risks/index_en.htm  

information 

scientists. 

More 

made 

up 

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of 

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The updated EQS represent, according to the latest scientific knowledge, an adequate level of 
protection of the aquatic environment and of human health via the aquatic environment. 

As  regards  the  status  of  existing  substances,  and  according  to  the  latest  information,  the 
substances  Di-(2-ethylhexyl)-phthalate  (DEHP)  and  Trifluralin  are  proposed  to  be  classified 
as priority hazardous substances. 

3.3. 

Identification of new priority substances 

Based  on  the  outcome  of  the  technical  process,  it  is  proposed  to  identify  the  following 
substances as priority substances: Aclonifen, Bifenox, Cybutryne, Cypermethrin, Dichlorvos, 
Terbutryn,  17alpha-ethinylestradiol,  17beta-estradiol  and  Diclofenac,  and  the  following  as 
priority  hazardous  substances:  Dicofol,  Perfluorooctane  sulfonic  acid  and  its  derivatives 
(PFOS),  Quinoxyfen,  Dioxins  and  dioxin-like  compounds,  Hexabromocyclododecane 
(HBCDD) and Heptachlor/heptachlor epoxide. 

Water EQS are being proposed for all the new substances except for Dioxins and dioxin-like 
compounds. Biota EQS are proposed for Dicofol, PFOS, Dioxins and dioxin-like compounds, 
HBCDD and Heptachlor/heptachlor epoxide. 

3.4. 

Review of substances in Annex III to Directive 2008/105/EC 

Four substances/groups of substances listed in Annex III to Directive 2008/105/EC are being 
proposed  for  inclusion  in  the  priority  substances  list:  Dicofol,  Dioxins  and  dioxin-like 
compounds, PFOS and Quinoxyfen. The inclusion of a fifth, the Dioxin-like PCBs, is covered 
by the inclusion of Dioxins and dioxin-like compounds. The toxicity data for non-dioxin-like 
PCBs are not sufficient to derive a reliable EQS and therefore these PCBs are not proposed 
for inclusion. 

For  the  other  substances  in  Annex  III  to  Directive  2008/105/EC,  the  review  concluded  that 
there  was  not  enough  evidence  of  significant  risk  to  or  via  the  aquatic  environment  at  EU 
level  to  include  them  at  this  stage  in  the  list  of  priority  substances.  In  the  context  of  future 
reviews of Annex X to Directive 2000/60/EC, the Commission will re-assess the information 
available and make proposals for inclusion in the priority substances list if appropriate. 

More details about the outcome of the review can be found in the accompanying Commission 
Staff Working Paper SEC(2011)1544.  

3.5. 

Identification of control measures at EU level 

At  the  time  of  the  Commission  proposal  in  2006, a review of the existing control measures 
concluded  that  numerous  acts  had  been  adopted  at  EU  level  since  2000  that  constituted 
control measures in the sense of Article 16 of the WFD. Additional measures at EU level were 
not  deemed  necessary  to  achieve  the  objectives  of  the  WFD.  It  was  considered  that,  if 
additional measures were necessary at local level, Member States could include them in their 
river basin management plans (see recitals 7 and 8 of the EQSD). 

Since then, the legislation to control the authorisation and placing on the market of chemicals 
has been substantially expanded and improved, in particular with the adoption of Regulation 
(EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of 

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Chemicals (REACH)6 and of Regulation (EC) No 1107/2009 concerning the placing of plant 
protection products on the market7. This and other existing EU legislation (e.g. biocides and 
veterinary  medicines  legislation)  contains  mechanisms  suited  to  controlling  the  uses  and 
emissions  of  most  of  the  priority  substances  at  EU  level  (e.g.  evaluation,  restriction, 
authorisation).  These  existing  mechanisms  should  therefore  be  applied  before  others  are 
developed and should in principle be sufficient to achieve the objectives of the WFD.  

More information can be found in the Impact Assessment report SEC(2011)1547. 

3.6. 

Other outcomes  

The technical work and the consultation  process in the  context of  the review of  the priority 
substances  provided  the  opportunity  to  look  at  other  aspects  of  the  implementation  of  the 
EQSD.  

One  important  achievement  has  been  the  update  of  the  Technical  Guidance  for  deriving 
Environmental Quality Standards, which contains expanded and updated sections on sediment 
and  biota  standards.  This  has  allowed  the  derivation  of  standards  for  biota  for  those 
substances that, due to their intrinsic properties and their fate in the aquatic environment, are 
best  regulated  in  that  matrix.  This  will  significantly  improve  the  protection  offered  by  the 
EQSD. 

Another  important  aspect  has  been  the  identification  of  problematic  substances  that,  due  to 
their persistent, bioaccumulative and toxic behaviour, will continue to cause exceedances of 
the EQS for a long time, even though very stringent measures to limit emissions have already 
been  taken.  Because  of  their  characteristics,  they  merit  separate  treatment  in  terms  of  their 
monitoring and the presentation of their impact on chemical status.  

Finally,  the  review  has  identified  the  need  for  a  mechanism  to  improve  the  collection  of 
targeted and high-quality monitoring data from across the EU to support future prioritisation 
exercises. The impact assessment demonstrates the benefits of establishing such a mechanism. 

4. 

OUTLOOK FOR FUTURE REVIEWS OF ANNEX X TO DIRECTIVE 2000/60/EC 

The  review  of  the  priority  substances  list  was  undertaken  at  the  same  time  REACH 
implementation began and the European Chemicals Agency (ECHA) was being set up. Future 
prioritisation  exercises  will  take  advantage  of  the  wealth  of  information  provided  by  the 
REACH registration process, whose first deadline was in November 2010. Also, the expertise 
on risk  assessment  at  EU  level is  being concentrated in ECHA and other agencies that deal 
with risk assessment of other chemicals, such as the European Food Safety Authority (EFSA) 
for  pesticides  and  the  European  Medicines  Agency  (EMA)  for  pharmaceuticals.  For  future 
reviews of the priority substances list, the Commission will explore the possibilities to exploit 
in a more efficient way the expertise on risk assessment existing at EU level. This initiative 
should  also  ensure  that  there  continues  to  be  a  high  degree  of  coherence  and  consistency 
between  the  WFD  and  related  policies  such  as  chemicals,  biocides,  pesticides  and 
pharmaceuticals. 

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OJ L 396, 30.12.2006, p. 1-849.  
OJ L 309, 24.11.2009, p. 1-50.  

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