Draft QA/QC decision – State of Play Berlin – 2 May 2007

1. Draft QA/QC decision – State of Play Berlin – 2 May 2007 European Commission - DG Environment Unit D.2: Water and Marine

2. New title Draft COMMISSION DECISION of [Day Month 2007] adopting technical specifications for chemical monitoring in accordance with Directive 2000/60/EC of the European Parliament and of the Council

3. Article 1 Article 1Purpose This Decision provides general rules for sampling, sample treatment and analytical methods to be used in [surveillance and operational] monitoring chemical substances in bodies of surface and ground waters pursuant to Article 8 and Annex V of Directive 2000/60/EC. It establishes minimum performance criteria for analytical methods used by Member States to perform water chemical monitoring for such samples, and for demonstrating the quality of analytical results on the basis of Article 8, paragraph 3, of that Directive.

4. Article 3 Article 3Sampling and sample treatment [General rules for] Sampling and sample treatment procedures responding to requirements of Article 8 and Annex V of Directive 2000/60/EC shall follow recommendations of relevant international guidelines and/or standards, including relevant parts of EN ISO 5667[1]. [1] EN ISO 5667, Water quality - Sampling

5. Article 4 (1) Article 4Analytical methods 1. Member States shall ensure that any analytical methods, including laboratory, field and on-line methods, used for monitoring programmes carried out under the Directive 2000/60/EC are validated and documented according to the EN ISO/IEC-17025 standard. Accordingly, analytical methods used for monitoring physico-chemical or chemical measurands shall meet the performance criteria laid down in Article 5, paragraph 1, of this Decision.

6. Article 4 (2) • Pursuant to the above paragraph and in accordance with Annex V, paragraph 1.3.6, of Directive 2000/60/EC, the provision of chemical data by Member States shall be ensured by analytical methods that: • a. conform to relevant international or national standards or to other national or international standards; or • b. alternatively by analytical methods that are not standardised but provide data of equivalent or better scientific quality and comparability than standard analytical methods.

7. Article 4 (3) 3. In the case of monitoring of operationally defined measurands, for example groups of chemical substances or extractable fractions of a given substance, the use of relevant standard analytical methods [adopted by ISO or CEN] is mandatory and shall be specified while reporting monitoring results for these measurands.

8. Article 5 (1) Article 5Minimum performance criteria for analytical methods 1. Minimum performance criteria for analytical methods used in monitoring programmes carried out under Article 8 of Directive 2000/60/EC shall be based on: a. a relative target uncertainty of 50% measured at the level of the relevant quality standards, in accordance with paragraph 2 [and 3]; and b. a limit of quantification equal or below a value of 0.3 of relevant quality standards in accordance with paragraph 2 [and 3].

9. Article 5 (2) 2. For the determination of priority substances and groundwater pollutants, quality standards pursuant to provisions of paragraph 1 shall be environmental quality standards established in accordance with Article 16 of Directive 2000/60/EC and groundwater quality standards set up under Directive 2006/118/EC.

10. Article 5 (3) 3. For the determination of pollutants for which no quality standards have been established at Community level or at another level pursuant to Directive 2006/118/EC, and which are nevertheless monitored under Article 8 of Directive 2000/60/EC, analytical methods shall fulfil the requirements of Article 7 of this Decision, and minimum performance criteria shall [take into account, where relevant, national or regional quality standard values] be defined in accordance with the international analytical state of the art and technical specifications of selected analytical methods.

11. Article 5 (4) - New 4. Where it is technically infeasible or disproportionately expensive to achieve the provisions of paragraph 1, minimum performance criteria shall take into account the achievable values from the current state of the art for routine analytical methodologies.

12. Article 6 Article 6Data below Limits of Quantification In case the amounts of physico-chemical or chemical measurands in a given sample monitored pursuant to Article 8 of Directive 2000/60/EC are below the limit of quantification, the measurement shall be set to half of the value of the limit of quantification. [NB1: no consensus on this article yet – concerns compliance, may lead to false positives, adding « except for total pesticides »] [NB2: no solution yet found for substances for which EQS are too low to achieve 5(1) performance criteria. Linked to PS Directive negotiation]

13. Article 7 (1) Article 7Quality assurance and control 1. In order to ensure the quality of analytical results for samples collected pursuant to Article 8 and Annex V of Directive 2000/60/EC, Member States shall ensure that laboratories responsible for water, sediment or biota chemical monitoring use quality management system practices according to the principles of EN ISO/IEC-17025 [including, where possible, the verification of the traceability to internationally recognised measurement standards]

14. Article 7 (2) 2. In accordance with paragraph 1, Member States shall ensure that: a. Laboratories demonstrate their competence for analysing the relevant physico-chemical or chemical measurands covered by Article 8 and Annex V of Directive 2000/60/EC by, where appropriate, participation in proficiency testing programmes in accordance with item 2b and paragraph 3 of this article, and/or verification of the methods by analysis of suitable reference materials that are representative of collected samples and at appropriate levels of concentrations in relation to quality standards referred to in paragraphs 2 and 3 of Article 5 of this Decision. b. Results of participation in proficiency testing programmes are evaluated on the basis of scoring according to ISO-13528[1], ISO/IEC guide 43-1[2] or equivalent scoring systems. c. Quality control of sampling and sample handling is considered, taking into account relevant international guidelines and/or standards. Where possible, the uncertainty from sampling shall be incorporated into the total measurement uncertainty of final monitoring results.

15. Article 7 (3) 3. In the context of paragraph 2, proficiency testing programmes are those organised by accredited organisations or at least internationally or nationally recognised organisations following requirements of ISO/IEC 43-1 or equivalent requirements.

16. Article 8 (1) Article 8[Accreditation] Quality management 1. Member States shall ensure that laboratories appointed for carrying out chemical monitoring under Article 8 and Annex V of Directive 2000/60/EC are accredited by a competent authority for sampling and measurements at the latest by 22 December 2012, subject to the application of paragraph 2.

17. Article 8 (2) 2. In case accreditation is not feasible for sampling or measurement of a given measurand, Member States shall ensure that: a. the laboratory responsible for the measurement comply with requirements set out in Article 7 of this Decision; b. the personnel responsible for the sampling comply with relevant provisions of Article 7 of this Decision as well as EN IS0 5667 [the personnel responsible for monitoring operations conform to certification rules in accordance with ISO/IEC 17024]

18. Article 8 (3) 3. In accordance with paragraphs 1 and 2, Member States shall ensure that laboratories participate in quality assurance programmes, including proficiency testing schemes, suitable training and exchanges of best practices, quality assurance tools, [are] coordinated at national or Community level.