Policy update with
regard to Priority and
Emerging Substances
SOCOPSE Final Conference
Maastricht, 24-25 June 2009
Jorge Rodriguez Romero
WFD Team Coordinator
DG Environment, European Commission
water.europa.eu
Contents
• Priority substances: state of play
• Priority substances vs emerging substances
• Working with other related legislation (REACH,
pesticides, biocides, …)
• Outlook
Socopse Final Conference, 24.6.2009
Legal framework
• Article 16 of WFD
• 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 2011. 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.
Socopse Final Conference, 24.6.2009
Prioritisation principles
• Significant risk to or via aquatic environment,
including to surface waters used for drinking water
• Identification of risks through
1. Risk assessments under chemicals, pesticides or biocides
legislation
2. Targeted risk assessment focusing only on toxicity to or via
aquatic environment
3. Simplified risk-based assessment procedure based on
scientific principles and taking into account
•
intrinsic hazard
•
monitoring data
•
production volumes and/or use patterns.
Socopse Final Conference, 24.6.2009
Tier 1: risk assessments under
chemicals, pesticides, biocides
• 97 finalised risk assessment reports under Existing
Substances Regulation 793/93 (+24 drafts)
• 334 pesticides active substances in Annex I Directive
91/414/EEC
• 14 substances included in Annex I of Directive
98/8/EC on biocides
• Subsidiarity: Priority substances should be an EU
wide problem, otherwise should be regulated at
national/RBD level (as part of ecological status)
Socopse Final Conference, 24.6.2009
Tier 3: Simplified risk assessment
• 2001 priority list: COMMPS (Combined Monitoring-based and
Modelling-based Priority Setting)
• New data collection 2008-2009
COMMPS 1999
Monitoring risk ratio-based
approach 2009
Nb Countries
15 + Eureau
28 + Vewin
A priori non candidate substances
Al, Br, Fe, NH3, Cyanides,
DDT, phenols, etc.
No
Nb candidate substances
314 (water)
221 (sediment)
1 147
Nb substances (manageable list)
95 (water)
60 (sediment)
317
Nb water analysis
752 043
13 581 264
Nb sediment analysis
68 880
918 839
Nb biota analysis
0
78 863
Socopse Final Conference, 24.6.2009
Tier 3: Simplified risk assessment
Monitoringbased ranking
Modellingbased ranking
Central database
data collection
preparation and
treatment
Establishment of
the universe of
chemicals
Establishment of
the manageable
list
Assessment of
exposure and
hazard
Scoring
Evaluation of
exposure and
effects data
Application of
fugacity modelling
Application of
prioritisation
algorithm
1st Expert review
(de-selection
criteria)
1st Expert review
(de-selection
criteria)
List of substances

List of substances

Consideration
of risk ratio
and other
criteria
2nd Expert review
(de-selection
criteria)
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.
Opinion of CSTEE on COMMPS 28.09.99
Final list of
substances
Socopse Final Conference, 24.6.2009
Additional substances of concern
• Directive 2008/105/EC Annex III substances (13)
• Existing substances regulation PBTs (27)
• REACH Substances of Very High Concern SVHC (16)
• ECHA recommended recently 7 of them for authorisation
• Persistent Organic Pollutants POPs
• Others: OSPAR priority, pharmaceuticals, etc
Socopse Final Conference, 24.6.2009
Historical pollutants
• PCBs, dioxins
• Heavily regulated since years
• Still causing problems due to PBT properties
• There are arguments in favour of listing them as
priority substances
• Trigger for action
• From a regulatory point of view, the reason for including these
chemicals in the list is the need for assessing the effectiveness of
existing measures and the evolution of water quality as a
consequence of the measures. (CSTEE 1999)
Socopse Final Conference, 24.6.2009
EQS setting
• EQS Technical Guidance in final draft stage
• Testing period over next months
• To be finalised by the end of 2009
• Water – sediment – biota
Socopse Final Conference, 24.6.2009
Priority vs emerging substances
• WFD article 16: significant risk to or via aquatic
environment
• There is no place for emerging pollutants if risk is not
demonstrated – e.g. presence is not enough
RESEARCH (e.g.
REACH
Not monitored
NORMAN network,
Modelkey)
Not regulated
Socopse Final Conference, 24.6.2009
Scarcity of monitoring data
• Example: PFOS
• Annex III Directive
2008/105/EC
Analysed Fraction 6 5
Analysis 6 5
Fish - Fish Liver
15
Mussel - Mussel Whole
9
Sediment - Fraction <2mm (whole)
62
Water - Whole water with no separation of liquid and SPM
phases
42
Socopse Final Conference, 24.6.2009
Quality of monitoring data
• Example: Triphenyltin
compounds
Matrix
Water
Analysis for which
LOD>2*PNEC
Fraction
Nb of total
analysis
Nb
Percentage
Whole water
16017
15666
97,8%
Number of analysis with
both LoD and LoQ
611
Socopse Final Conference, 24.6.2009
Control measures
• WFD Article 16(6)
• Commission proposal in 2006: existing measures at
Community level should be sufficient to achieve the
objectives – this needs to be looked at
• Revision of river basin management plans: pressures
– status – measures
• Activity on emissions under WG E Priority
Substances
• Research projects (like SOCOPSE)
Socopse Final Conference, 24.6.2009
Working with other legislation
• REACH
• Registration dossiers
• Annex XV dossiers (SVHC)
• Evaluations
• Pesticides & biocides
• Authorisations for use
• WFD as downstream safety net to ensure measures
taken to mitigate the risk are efficient – and providing
a feedback mechanism to those other policies in case
further product controls are needed
Socopse Final Conference, 24.6.2009
Outlook
• Overall methodology for WFD article 16 Community
action to be consolidated, to be used in future
updates, including relationship with other legislation
• Progressively evolving in the future
• Improve information base
• Chemical monitoring in Member States (Commission Directive on
QA/QC to be adopted in July 2009)
• REACH (ecotoxicological data, use patterns)
• Effectiveness of measures: RBMP cycle
• Emerging substances
• Research (Socopse, ScorePP, Modelkey, Neptune, …)
Socopse Final Conference, 24.6.2009
Thank you for your attention
water.europa.eu
Socopse Final Conference, 24.6.2009