DIN CEN/TS 16800:2016-03

Environmental monitoring of chemical substances is increasingly carried out within a European framework and there is a problem of comparability of data at the European level. In particular, methods for monitoring new substances of interest have often not been adequately validated either internally within laboratories (that is, within a single laboratory) or at the international level. These problems can be addressed by adopting a harmonized approach with respect to procedure development and validation. The main objective of the present document is to provide a common European approach for the validation of chemical methods for the respective monitoring of chemical substances (or their effects) in a wide range of sample matrices. Although the development of this approach has been triggered by the need for monitoring emerging pollutants, the approach is generic in nature and thus can be applied to the measurement of a wide range of substances (or their effects) in a variety of matrices. This guidance takes into account the different requirements for the level of sophistication of the process and the level of validation in the different levels of investigation or regulation of chemical substances. In the case of a specific monitoring task, this protocol will guide the user through the following steps: - classification of existing procedures with respect to their validation status and selection of the appropriate validation approach; - development of a procedure with respect to the extension of its scope; for example, when a procedure is available to determine a required target compound in a particular matrix, but is unsuitable for the same compound in another matrix under investigation; - validation procedures to be performed to effectively demonstrate the validation status of a selected procedure according to the two adopted approaches. Many (national and international) standards currently include in their scope a statement such as "this method applies to a concentration level of×µg/l or y mg/kg dry matter" without any indication of how this concentration level has been determined. If the limit of quantification (LOQ) has been evaluated using the procedure in this guidance, then there is a possibility that it does not correspond to the lower limit of the specified range. This document (CEN/TS 16800:2014) has been prepared by Technical Committee CEN/TC 230 "Water analysis", the secretariat of which is held by DIN (Germany). The following Technical Committees in the field of environmental analysis were involved in the preparation of this document: CEN/TC 292 "Characterization of waste", CEN/TC 308 "Characterization and management of sludge", CEN/TC 345 "Characterization of soil" and CEN/TC 400 "Project Committee - Horizontal standards in the fields of sludge, biowaste and soil". The responsible German committee is Working Group NA 119-01-03-06-01 AK "Analytical quality assurance for chemical and physico-chemical water analysis" of Working Committee NA 119-01-03 AA "Wasseruntersuchung" ("Water examination") at DIN Standards Committee Water Practice (NAW). Working Group NA 119-01-02-06 AK "Method validation" of Working Committee NA 119-01-02 AA "Examination of waste and soil" has also been involved in the processing on behalf of Germany.