International Federation for Consulting GmbH IFC

1. The Commission Decision 2002/657/EC Performance criteria by Dr. Michael Scheutwinkel International Federation forConsulting GmbH IFC

2. Content of Annex of CD 2002/657/EC 1 1 Definitions 2 Performance criteria and other requirements for analytical methods 2.1 General criteria to be fulfilled by any technique, procedure, etc. 2.2 Criteria for screening methods 2.3 Criteria for confirmatory methods (organics) 2.4 Criteria for confirmatory methods (elements) 3 Recommended valdidation procedures - classical validation - alternative validations, e.g. InterVal 2 3

3. Performance criteria according to CD 2002/657/EC 2.1 General requirements 2 1 Sample handling Test performance Maximum chance for the detection of the analyte Recovery with each batch of samples Specifity

4. Commission Decision 2002/657/EC

5. Performance criteria according to CD 2002/657/EC 2.2 Screening methods In case of a suspected non-compliant result, a confirmation is obligatory. False compliant rate < 5 % (β-error)

6. Suitable confirmatory methods according to CD 2002/657/EC, here only extract Table 1

7. Commission Decision 2002/657/EC Table 9

8. Commission Decision 2002/657/EC Table 10

9. Performance criteria according to CD 2002/657/EC 2.3 Confirmatory methods for analysis of organics, common requirements 3 1 Use of internal standard or confirmation by co-chromatogaphy No discrimination in cases that two compounds give same response, only chromatographic analysis without spectrometric detection is not appropriate. 3 Use of CRM or fortification of material

10. Performance criteria according to CD 2002/657/EC 2.3 Confirmatory methods for analysis of organics, specific requirements 1 2 Minimum trueness (Table 2) Reproducibility CV(%) (Table 3) CV = interlaboratory coefficient of variation in % MRL existing? CV = 50% of limit

11. Commission Decision 2002/657/EC Table 3

12. Commission Decision 2002/657/EC Table 2

13. Commission Decision 2002/657/EC

14. Performance criteria according to CD 2002/657/EC Confirmatory methods for analysis of organics, performance criteria for MS Chromatographic separation MS detection Usually full scan, < 10% deviation from reference MS SIM S/N ratio > 3:1 Full scan + SIM see table 4

15. Commission Decision 2002/657/EC

16. Commission Decision 2002/657/EC

17. 2.3 Confirmatory methods for organics, performance criteria LC with different detection techniques Chromatography coupled to infrared detection GC-ECD 2-D TLC coupled to full-scan UV/VIS spectrometric detection

18. Commission Decision 2002/657/EC

19. Commission Decision 2002/657/EC

20. Commission Decision 2002/657/EC Table 5

21. Commission Decision 2002/657/EC Table 6

22. Performance criteria according to CD 2002/657/EC Table 4

23. Commission Decision 2002/657/EC Table 6

24. Commission Decision 2002/657/EC

25. Commission Decision 2002/657/EC

26. 2.4 Confirmatory methods for elements, see also table 7 Differential pulse anodic strippingvoltametry Trueness of quantitative tests AAS ICP-AES ICP-MS

27. Commission Decision 2002/657/EC Table 7

28. Commission Decision 2002/657/EC Table 8