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Harmonised protocols for method validation for monitoring and biomonitoring of emerging pollutants - Developed by the NORMAN network

Abstract : Comparability and reliability of monitoring data are essential for any meaningful assessment and for the management of environmental risks. For emerging pollutants, there is concern regarding the comparability of data at the European level. Methods used for the monitoring of emerging pollutants have often not been properly validated either in-house or at the international level. Such methods are often not well established in the scientific community, and far from being harmonised or standardised. In addition, they may only be applicable to specific conditions (matrix, organism) which may further complicate data comparability. Within the EU-funded coordination action "NORMAN - Network of Reference Laboratories for Monitoring and Bio-monitoring of Emerging Pollutants", a common European approach to the validation of both chemical and biological methods for the respective monitoring and bio-monitoring of emerging pollutants (or their effects) in a broad range of matrices has been developed. This guidance document addresses three different validation approaches, in increasing order of complexity. These are : 1. Within-laboratory validation (research level) ; 2. Basic external validation (transferability at expert level) ; 3. Inter-laboratory validation (routine level). The concept of these three approaches is strictly hierarchical, i.e. a method must fulfil all criteria of the lower level before it can enter the validation protocol of a higher level. In the case of a specific monitoring task, this protocol will guide the user through the following steps : I. Evaluation and classification of existing methods with respect to their potential, both in terms of validation, and the selection of an appropriate validation approach ; II. Development of a method, in terms of extending its application ; III. The validation procedures to be undertaken in order to effectively demonstrate the validation status of a selected method according to the three approaches adopted. The scope of the harmonised protocol covers quantitative and qualitative biological and chemical test methods for the analysis of water, air, soil and biota. The protocols have been tested in three case studies, each one matching one of the three validation levels. Based on the feedback from the case studies, the protocols have been improved. Future validation studies (for methods to monitor emerging pollutants) by the NORMAN network will make use of the protocols, and it is intended to implement the protocols at the level of European Standardisation (e.g. as CEN guidance document).
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https://hal-ineris.archives-ouvertes.fr/ineris-00970544
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Submitted on : Wednesday, April 2, 2014 - 3:52:14 PM
Last modification on : Wednesday, March 7, 2018 - 8:26:01 PM

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  • HAL Id : ineris-00970544, version 1
  • INERIS : EN-2009-335

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David Schwesig, Ulrich Borchers, Laure Chancerelle, Anja Duffek, Ulla Eriksson, et al.. Harmonised protocols for method validation for monitoring and biomonitoring of emerging pollutants - Developed by the NORMAN network. 12. EuCheMS International Conference on Chemistry and the Environment (ICCE 2009), Jun 2009, Stockholm, Sweden. pp.19. ⟨ineris-00970544⟩

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