CMA-3 Support to Standardisation 6 th CMA Plenary Meeting under the German Presidency Berlin, 02 nd May 07 (modified: 03 rd 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 River Basins in Europe Strong needs for co-ordination and harmonisation at EU level

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

5 CMA-3 Core Activities Identification and evaluation of standardisation needs and appropriate actions related to them  Discussion on standardisation needs related 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

6 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  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

7 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 key point 1

8 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 key point 2 key point 3

9 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

10 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

11 Table of methods and their performance

12 Table of methods and their performance

13 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

14 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

15 Summary (41 substances) 1 st cat.: Everything is OK  for about 10 substances 2 nd cat.: Lack of data for LOQ, U, or SPM at the time being but 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!

16 Summary (41 substances) 3 rd 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 4 th cat.: Standardised method does not exist:  C10-13-chloroalkanes (SCCP)  Pentabromodiphenylether (PDBE)

17 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 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

18 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

19 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  15 th June 2007, Vienna meeting Drat list of methods with consolidated data for adoption by CMA Plenary  30 th June 2007 Task 2:  Proposal of a list of standards for Annex V  Only those 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  16 th October 2007, Brussels

20 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  31 th July 2007, Commenting by

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

22 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  31 st July 2007