Water.europa.eu Policy update with regard to Priority and Emerging Substances SOCOPSE Final...

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Policy update with Policy update with regard to Priority and regard to Priority and Emerging SubstancesEmerging Substances

SOCOPSE Final ConferenceMaastricht, 24-25 June 2009

Jorge Rodriguez RomeroWFD Team CoordinatorDG Environment, European Commission

Socopse Final Conference, 24.6.2009

Contents Contents

• Priority substances: state of play

• Priority substances vs emerging substances

• Working with other related legislation (REACH, pesticides, biocides, …)

• Outlook


Legal framework 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.


Prioritisation principles 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.


Tier 1: risk assessments under Tier 1: risk assessments under chemicals, pesticides, biocides 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)


Tier 3: Simplified risk Tier 3: Simplified risk assessment assessment

• 2001 priority list: COMMPS (Combined Monitoring-based and Modelling-based Priority Setting)

• New data collection 2008-2009

COMMPS 1999Monitoring risk ratio-based

approach 2009

Nb Countries 15 + Eureau 28 + Vewin

A priori non candidate substancesAl, Br, Fe, NH3, Cyanides,

DDT, phenols, etc.No

Nb candidate substances314 (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


Tier 3: Simplified risk Tier 3: Simplified risk assessment assessment Monitoring-Monitoring-

based rankingbased rankingModelling-Modelling-

based rankingbased ranking

Establishment of the manageable

list

Establishment of the universe of

chemicals

Central database data collection

preparation and treatment

Assessment of exposure and

hazard

Scoring

Application of fugacity modelling

1st Expert review(de-selection

criteria)

List of substances

Consideration of risk ratio and other criteria

2nd Expert review(de-selection

criteria)

Evaluation of exposure and effects data

Application of prioritisation

algorithm

List of substances

1st Expert review(de-selection

criteria)

Final list of Final list of substancessubstances

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


Additional substances of concernAdditional 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


Historical pollutantsHistorical 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)


EQS settingEQS setting

• EQS Technical Guidance in final draft stage

• Testing period over next months

• To be finalised by the end of 2009

• Water – sediment – biota


Priority vs emerging substancesPriority vs emerging substances

Not monitored

Not regulated

• 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. NORMAN network,

Modelkey)REACH


Scarcity of monitoring data Scarcity of monitoring data

Analysed Fraction Analysis

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

• Example: PFOS

• Annex III Directive 2008/105/EC


Quality of monitoring data Quality of monitoring data

• Example: Triphenyltin compounds

Matrix FractionNb of totalanalysis

Analysis for which LOD>2*PNEC

Nb Percentage

Water Whole water 16017 15666 97,8%

Number of analysis with both LoD and LoQ 611


Control measuresControl 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)


Working with other legislationWorking 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


OutlookOutlook

• 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, …)


Thank you for your attentionThank you for your attention

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Water.europa.eu Policy update with regard to Priority and Emerging Substances SOCOPSE Final...

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