1. Review of the WFD priority substances list
WG E Priority Substances
6 July 2009
Jorge Rodriguez Romero
Madalina David
DG Environment, European Commission

2. Contents
Room document WG E(6) Review of the WFD Priority Substances list
Background and objective of the paper
Principles for identification of priority substances
Candidate list for inclusion in WFD Annex X
Proposal for expert review – expert group
Timetable

3. Recall legal framework
Author: DG Environment
Article 8 of Directive 2008/105/EC (EQSD)
Within the framework of the review of Annex X to Directive 2000/60/EC, as provided for in Article 16(4) of that Directive, the Commission shall consider inter alia the substances set out in Annex III to this Directive for possible identification as priority substances or priority hazardous substances. The Commission shall report the outcome of its review to the European Parliament and to the Council by 13 January It shall 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.

4. Aim of the paper Review work on-going since 2007
The purpose of this paper is to describe briefly the main steps needed complete the review of priority substances list and establishment of corresponding EQSs by January 2011.
The review may involve all or some of the following elements:
adding new substances to the list of priority substances (PS) and/or priority hazardous substances (PHS)
establishing the appropriate EQSs for the PH/PHS for water, sediment and/or biota, including revision of EQS for existing PS/PHS as appropriate;
establishing control measures for PS/PHS.

5. WFD Article 16: principles of prioritisation
Significant risk to or via aquatic environment, including to surface waters used for drinking water
Identification of risks through
Risk assessments under chemicals, pesticides or biocides legislation
Targeted risk assessment focusing only on toxicity to or via aquatic environment
Simplified risk-based assessment procedure based on scientific principles and taking into account
intrinsic hazard
monitoring data
production volumes and/or use patterns.

6. 2001 Priority substances list
At the time the first identification of priority substances was carried out, very few risk assessment were available under the chemicals, pesticides and biocides legislation.
Simplified risk-based assessment: COMMPS (Combined Monitoring-based and Modelling-based Priority Setting)
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 that should be taken into account when identifying priority substances under WFD.

7. Article 16(2)a: risk assessments chemicals legislation Reg 793/93
Since 1994 a total of 4 priority lists comprising 141 substances were drawn by the Commission in consultation with Member States to carry out risk assessments under Regulation 793/93.
102 Risk Assessment Reports (RAR) concluded
49 have identified risks to or via the aquatic environment (not counting existing PS)
35 Commission Recommendations to reduce risk have been published in the Official Journal.

8. Article 16(2)a: risk assessments pesticides legislation Dir 91/414/EEC
334 active substances included in Annex I of Directive 91/414/EEC
766 active substances have been subject to a non-inclusion decision
151 active substances need risk reduction measures due to the risk to surface waters

9. Article 16(2)a: risk assessments biocides legislation Dir 98/8/EC
There are 14 active substances in Annex I of Directive 98/8/EC
Of those, the annex identifies risks to the aquatic environment in 4 cases
Annex I is about to be amended to add 15 additional active substances
Around 300 active substances are under review at the moment

10. Article 16(2)b: targeted risk assessments
Some of the substances that were prioritised for risk assessment under Regulation 793/93 were submitted as REACH transitional dossiers as the risk assessments were not concluded at the time REACH entered into force
A number of voluntary risk assessments have been carried out which can be considered as following the methodology of Regulation 793/93 and therefore would fall under Article 16(2) paragraph b

11. Article 16(2), second part: simplified risk assessments
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

12. Article 16(2), second part: simplified risk assessments
Building on COMMPS and the SCTEE opinion, a new simplified methodology is being developed by the Working Group on Priority Substances since 2006.
Following extensive discussions and consultation, a pragmatic choice was made to run in parallel the following 2 methodologies:
A monitoring-based methodology elaborated by DG Environment’s consultant INERIS and
A modelling-based methodology that is being developed by the JRC-lead Expert Group based mainly on the UK methodology

13. Article 16(2), second part: simplified risk assessments
Both methodologies complement each other, as the SCTEE recognised in its opinion.
“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

14. Priority Hazardous Substances
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:
REACH Substances of Very High Concern (SVHC) – 15 substances, 12 non PS
Persistent Organic Pollutants (POPs) under the Stockholm Convention – 21 substances, 10 non PS
Substances identified as Persistent, Bio-accumulative and Toxic (PBTs) under Regulation 793/93 – 27 substances, 9 non PS

15. Other sources for identification of candidates for PS
Annex III of Directive 2008/105/EC - 13 substances
Member States identified (questionnaire 2007) a number of substances of concern that are causing pollution problems and are likely to put at risk the achievement of the WFD objectives – 19 substances identified by 10 or more MS

16. Annex 1 to WG E(6)-09-04 Candidate list of substances
To be completed with the substances resulting from modelling-based prioritisation
284 substances
151 pesticides in Annex I of Directive 91/414/EEC
It is proposed that the list of substances in annex I, completed with the results of the modelling-based procedure, serves as the starting point to undertake an expert review step that should inform further decisions on prioritisation

17. Annex 1 to WG E(6)-09-04 Candidate list of substances

18. Expert review
In deciding whether a particular substance should be prioritised, all available evidence and information should be used
It is proposed that the Expert Group assesses all available evidence and information of the candidate substances in Annex I and provide their conclusions to the Working Group E

19. A tiered approach to prioritisation
Need to perform some screening to keep the work load manageable for the Expert Group
Some proposed criteria
Pesticides and biocides that are in the candidate list only due to the identification of risk to the aquatic environment in the Annex I to Directive 91/414/EEC and Annex I to Directive 98/8/EC (i.e. they are not ranked high in the simplified risk assessment procedures) should not be further investigated unless additional information is made available
Substances for which the risk assessment report identifies a risk but this is explicitly and unequivocally identified as of local nature should not be further investigated
It is proposed that the Expert Group elaborates further these screening criteria.

20. Expert review working method
Case by case assessment: substance data sheets
A template for such data sheets should be agreed by the Expert Group
The data sheets will then be the basis for the development of the EQS that the Expert Group will also oversee
The conclusions of the Expert Group should be forwarded to the Working Group and should consist of:
Whether the available evidence shows that the candidate substance should be included on the list of priority substances as PS or PHS
If this is the case, whether the substance should be regulated through EQS for water, sediment and/or biota, and the proposals for such EQS
Any differences of opinion should be highlighted and made transparent

21. Expert Group
It is proposed that the existing Expert Group chaired by JRC and the UK is mandated to carry out the expert review described above
Assisted by DG Environment’s consultant
Tasks of the Expert Group
Concluding the EQS guidance, taking into account the testing
Conclude the modelling-based prioritisation
Review the results of the INERIS monitoring-based approach – quality and representativeness of the monitoring data used
Review the list of candidate substances, to report to the WG whether the available evidence shows that the candidate substance should be included on the list of priority substances as PS or PHS and, if this is the case, whether the substance should be regulated through EQS for water, sediment and/or biota, and the proposals for such EQS

22. Timetable
Running and finalisation of monitoring based prioritisation methodology
July 2009
Test the methodology for EQS derivation based on draft TGD and on the results of the monitoring-based prioritisation
July – September 2009
Meeting of the Expert Group
Conclude the TGD on EQS
Progress on modelling-based prioritisation
Review of the results of the monitoring-based prioritisation
Start the review of the candidate substances in Annex 1 to this document, including screening criteria and agreement on the template for the substance specific data sheet
Plan further meetings
14-15 September 2009 (Brussels)

23. Timetable Endorsement of TGD on EQS by WG E 13-14 October 2009
Establishment of EQSs and preparation of the data sheets for each substance
October 2009 – February 2010
Finalisation of modelling based prioritisation methodology
December 2009
WG E meeting
- Final discussion on the results of modelling based ranking application as well as of the overall results of prioritisation exercise
- Final discussion on the data sheets for each substance
15-16 March 2010
WG E meeting (as needed)
June 2010
Consultation with SCHER, impact assessment, procedural steps
June - December 2010
Commission proposal
January 2011

24. Overall approach to prioritisation

25. The WG members are invited to
Take note of the document
Agree to mandate the Expert Group as proposed
Indicate any missing or wrong information in Annex 1
Indicate whether any additional substance should be included in Annex 1 as candidate for review, attaching justification or evidence on which the proposal is based
Send comments in writing no later than 24 July 2009