CMA-3 Support to Standardisation

1. CMA-3 Support to Standardisation 6th CMA Plenary Meetingunder the German Presidency Berlin, 02nd May 07 (modified: 03rd May 07) modified according to discussions at the meeting,and further data supplied by B, A, DE are considered Ulrich Borchers and Peter Lepom

2. Agenda • Introduction on Requirements for Methods • From the WFD • From the EQS Daughter Directive • From the QA/QC COM decision • State of the Art of standardised analytical methods • Modified AMPS table / Substance guidance sheets • CEN/UBA enquiry 2005 / Comments NL, UK • Ongoing standardisation activities • Definition of needs and further steps • Standards for the WFD Annex V • Research needs (new methods) • Revision and optimisation of existing methods

3. CMA 2007 – 2009 – Tasks and Deliverables STRATEGIC CO-ORDINATION GROUP WG E PLENARY CMA (GW, SW/MW) WG C or WG E (joint meetings) CMA-1 Exchange of best practices CMA-3 Standardisation (CEN TC/230) CMA-2 QA_QC • Sharing best practices • Identification of gaps and needs • Analytical methods, sampling • Practical exercises • Sediment and biota • Identification of standards • Follow-up of CEN work • Links with RTD • Follow-up of COM decision • Discussion of common strategy (EAQC-WISE)

4. CMA-3 Core Activities • Identification and evaluation of standardisation needs and appropriate actions related to them • Discussion on standardisation needsrelated to WFD chemical monitoring • Establishment of lists of • Existing standards fit for purpose • Standards that need to be revised • Standards that need to be developed • Proposal of a) Existing standards for adoption b) Development of new standards mandated to CEN

5. WFD Requirements for analytical methods • Article 8.3 • Technical specifications and standardised methods for analysis and monitoring of water status shall be laid down in accordance with the procedure laid down in Article 21 • Annex V, paragraph 1.3.6 • the provision of chemical data by MS shall be ensured by analytical methods • that conform to relevant international or national standards or to other national or international standards • or alternatively by analytical methods that are not standardised but provide data of equivalent or better scientific quality and comparability than standard analytical methods

6. key point 1 Requirements from the EQS Daughter Directive* • EQS values (Article 2) • In conjunction with Limit of Quantification (LOQ) requirements in the QA/QC COM decision • Monitoring based on annual averages • … and as a maximum allowable concentration • That means: time integrating sampling methods (e.g. passive samplers) offer important and new possibilities • But these methods are not directly intended for compliance checking in whole water samples • Matrix • “Whole water”, SPM, sediment, biota • Indicator parameters * Proposal for a Directive of the European Parliament and of the Council on environmental quality standards in the field of water policy and amending Directive 2000/60/EC

7. key point 2 key point 3 Requirements from QA/QC COM decision • Sampling and sample treatment • … shall follow recommendations of relevant international guidelines and standards, including relevant parts of ISO 5667 • Limit of quantification (LOQ) • … equal or below a value of 0.3 of the relevant quality standards (EQS) • LOQ versus Lower Limit of Application (LLOA) • LOQ = lab specific performance value • LLOA = method specific performance value • Relative Target Uncertainty • … a relative target uncertainty of 50% measured at the level of the relevant EQS

8. Agenda • Introduction on Requirements for Methods • From the WFD • From the EQS Daughter Directive • From the QA/QC COM decision • State of the Art of standardised analytical methods • Modified AMPS table / Substance guidance sheets • CEN/UBA enquiry 2005 / Comments NL, UK • Ongoing standardisation activities • Definition of needs and further steps • Standards for the WFD Annex V • Research needs (new methods) • Revision and optimisation of existing methods

9. State of the Art of standardised analytical methods • Basis of information on the performance of methods • AMPS table accepted by EAF-7 • modified by JRC IES and EAQC-WISE in March 2007 • CEN/UBA enquiry on performance criteria (LOQ etc.) among labs from Europe • A problem of the statistical evaluation was that the responses of labs were not balanced regarding the MS • Emphasis on labs in F, Scandinavia and D • At the time being: some further enquiries among labs in • DE (Friederike Vietoris, LAWA), • UK (John Batty, EA) and • NL (Joan Staeb, RIZA) • A (Karin Deutsch) • B (Peter van Caeter) • concerning performance criteria of standard methods

10. Table of methods and their performance

11. Table of methods and their performance

12. State of the Art of standardised analytical methods • Lack of sensitivity of some methods • (LLOA) and/or LOQ to high • Statements in the standards • Practical experience in many labs • See various enquiries • Published LOQs and U are sometimes • Too optimistic (determined in ultraclean sample) • Too pessimistic (better with modern equipment) • In any case they are lab specific • We have no LOQ’s and U in the standards • Lack of reliable data on Measurement Uncertainty (U) • There is a need to assess realistic LOQ and U values but mainly in cases of doubts • In labs from different MS • e.g. by in house tests or by ring tests

13. State of the Art of standardised analytical methods • Pre-condition • Normal accredited and well qualified laboratories should be able to perform the monitoring • Lack of representativeness of the Validation trials in the existing standards • Matrix of tested waters not suitable • Concentration range much above EQS values • No or not clear statements on the suitability of the methods for “whole water samples” • Water with remarkable SPM content

14. Summary (41 substances) • 1st cat.: Everything is OK • for about 10 substances • 2nd cat.: Lack of data for LOQ, U, or SPM at the time beingbut high probability that collected data will be OK • for about 20 substances • it is likely that for about 30 substances we can show in due course that they are fit for purpose • only those methods should be mentioned where suitability is commonly agreed!

15. Summary (41 substances) • 3rd cat.: Existing standards are not suitable:(there is at least 1 of 3 criteria not OK: LOQ, U, SPM) • Problems with compliance checking for all waters • TBT • PAHs (6-ring-PAH) • Triflualin • Problems mainly for marine waters • HCH (4 relevant isomers) • Octylphenol • Endosulfan (a+b) • Pentachlorobenzene • Aldrin, Dieldrin, Eldrin, Isodrin • 4th cat.: Standardised method does not exist: • C10-13-chloroalkanes (SCCP) • Pentabromodiphenylether (PDBE)

16. Ongoing standardisation activities with WFD relevance • Polyaromatic Hydrocarbons (PAH´s) • GC MS method • new pre-treatment steps for waters containing SPM • ISO TC 147 / SC 2 / WG 19 (convenor: Van Zonen, NL) • ISO/CD 28540 • Organochloropesticides (OCP) • e.g. DDT, Pentachlorobenzene • Aldrin, Endrin, Isodrin, Dieldrin • ISO TC 147 / SC 2 / WG 53 (convenor: Van Zonen, NL) • only first WD and some experiments available • no ISO project number at the time being

17. Agenda • Introduction on Requirements for Methods • From the WFD • From the EQS Daughter Directive • From the QA/QC COM decision • State of the Art of standardised analytical methods • Modified AMPS table / Substance guidance sheets • CEN/UBA enquiry 2005 / Comments NL, UK • Ongoing standardisation activities • Definition of needs and further steps • Standards for the WFD Annex V • Research needs (new methods) • Revision and optimisation of existing methods

18. Definition of needs and road map(adjusted time table according to comments of PQ) • Task 1: • Discussion of the modified AMPS table(s), the list with performance data from UK, NL, DE, A, B (and others), the suitability of methods for SPM containing samples in CEN TC 230 / WG1  report with relevant conclusions • 15th June 2007, Vienna meeting • Drat list of methods with consolidated data for adoption by CMA Plenary • 30th June 2007 • Task 2: • Proposal of a list of standards for Annex V • Onlythose methods where suitability and performance criteria are commonly agreed at CEN and CMA level • Comments by relevant groups until end of July 07 • Adoption of the proposal at next CMA plenary meeting • Identification of methods for further discussion / collection of further information • 16th October 2007, Brussels

19. Definition of needs and road map(adjusted time table according to comments of PQ) • Task 3: • Definition and agreement on the list of methods to be developed and or revised in 3 parts: • 1) New methods  pre-normative research • 2) Methods with enhanced sensitivity optimisation / revalidation • 3) Methods with proved suitability for SPM containing waters (if relevance for analysis of SPM fraction is given)  optimisation of pre-treatment / revalidation • 31th July 2007, Commenting by e-mail

20. Definition of needs and road map(adjusted time table according to comments of PQ) • Task 4: • Definition and agreement ona new ISO standard (or TS) on passive sampling techniques • On the basis of BSI PAS 61:2006 • Launching of a NWIP at ISOTC 147 / SC 6 • Technical discussion on 15th June 2007, Vienna CEN meeting • Submission of NWIPto ISO CS 31st July 2007

21. Definition of needs and road map(adjusted time table according to comments of PQ) • Task 5: • Adoption of standards and mandates to CEN • Proposal of existing suitable standards to the WFD Committee for adoption by comitology and • Mandate on the development of new or revised standards involving pre- or co-normative research mandated to CEN, followed by adoption by comitology • 31st July 2007