Identification of standardisation needs in the light of the SW/MW Guidance development - 3rd CMA meeting - 23 March 2006, Brussels Ulrich Borchers, Germany, CEN TC 230

Why do we need standardisation? Standardisation supplies commonly accepted and validated tools where needed Standards can support policy making legislative activities e.g. by filling gaps (concerning technical issues) in guidance documents of the Commission

General statements (1) The results of chemical monitoring activities under the WFD have to be comparable reliable validated A fitness-for-purpose approach for analytical methods is commonly accepted and state of the art reflected in most of the recently published standards

General statements (2) But, to make this approach successfully, standardisation of some items is needed for general QA/QC requirements for proving the comparability and reliability of results for operationally defined parameters/procedures For operational defined parameter a close co-operation between relevant parties seems to be optimal research community policy makers standardisation bodies

General statements (3) The guidance documents should address the problem and the common understanding e.g. dissolved fraction means the filtrate of a 0,45 µm membrane filtration according to EN ISO #### But, the method should be described in detail and validated by a standardisation group

Basic Elements of Harmonisation of Chemical Analysis General tools and requirements Sampling procedures Sample pre-treatment and processing Analysis operationally defined parameters/procedures distinct parameters

General QA/QC tools (standards) What we have: competence of labs (ISO 17025) competence of PT providers (ISO 17024) requirements for PT schemes (ISO Guide 43-1/-2) evaluation of PT results (e.g. ISO 13528) comparability of methods/results What we still need: Validation of methods (criteria and approaches) Traceability of results Calculation of uncertainty (easy applicable approach) LOQ/LOD

Sampling methods (standards) What we have: ISO 5667 series, part 1 - 19 covering most techniques and matrices What we still need: SPM sampling methods passive sampling techniques Use of sampling data for decision making new ISO project: ISO/CD 5667-20

Sample pre-treatment (standards) Most of these methods/procedures are operationally defined!! What we have (only examples): aqua regia digestion of sediments/water nitric acid digestion of sediments/water What we still need: Filtration (dissolved fraction), 0,45 µm solvent extraction of sediments or SPM fractionation of particles (sieving/centrifugation) special extraction methods (e.g. bioavailability of metals)

Analytical methods (1) What we have (EU wide Survey on methods): For approximately 90% of the priority substances we have CEN or ISO standards suitable for compliance checking of EQS Standards are the most sensitive methods for Benzene Volatile halogenated compounds Di-Ethyl-Hexyl-Phthalates (DEHP) Octyl-/Nonylphenol Tributyl-Tin for some organo-chlorine pesticides

Analytical methods (2) Recently released standards actually represent the best and most sensitive methods for analysing PS in water Methods were applied in most EU MS often without modifications Application of Standards is often prescribed by Accreditation bodies

Analytical methods (3) What do we need: New methods for the determination of : C10-13 chloroalkanes (SCCP) pre-normative research urgently needed!! brominated diphenyl ethers (PDBE) in water hexachlorobutadiene, tributyl tin compounds (inland and marine waters) pentachlorobenzene (only marine waters) Modified methods suitable for waters with higher amounts of SPM New methods for SPM analysis see also pre-treatment requirements

Analytical methods (4) What we need: Re-validation of standards where experience has shown that better performance data are achievable where better performance criteria are necessary for compliance checking of the EQS Clarification of definition matching for substance groups or mixtures of isomers definitions in standards and legislation should be identically A common understanding of how to report results is essential e.g. for PDBE, SCCP, nonylphenols

Next steps Survey on existing research and standardisation projects in all relevant matrices within the EAQC-WISE framework Validation concepts for methods within NORMAN network Standardisation needs defined by CMA group and DG ENV Priority setting Launch of new work item proposals (NWI) at CEN or ISO level

What we offer CEN / TC 230 is well prepared to give any required technical input to the CIS of the WFD to support the CMA approach actively and will be happy to work on new methods for water and SPM to fill the gaps the further enhancement of methods