Division 4.3.1.2 ‘ Fitness-for-purpose ’ approachF1

United Kingdom

For in-house validated methods, as an alternative, a ‘fitness-for-purpose’ approach ^f1 may be used to assess their suitability for official control. Methods suitable for official control must produce results with a standard measurement uncertainty (u) less than the maximum standard measurement uncertainty calculated using the formula below:

$Uf = \sqrt{{(LOD/2)}^{2} + {(α \times C)}^{2}}$

where:

Uf is the maximum standard measurement uncertainty (μg/kg)
LOD is the limit of detection of the method (μg/kg)
α is a constant, numeric factor to be used depending on the value of C. The values to be used are set out in Table hereafter.
C is the concentration of interest (μg/kg)

If the analytical method provides results with uncertainty measurements less than the maximum standard uncertainty the method shall be considered being equally suitable to one which meets the performance criteria given in point 4.3.1.1.

Table

Numeric values to be used for α as constant in formula set out in this point, depending on the concentration of interest

C (μg/kg)	α
≤ 50	0,2
51-500	0,18
501- 1 000	0,15
1 001 - 10 000	0,12
> 10 000	0,1

Annotations

Textual amendments

F1: Substituted by Commission Regulation (EU) No 519/2014 of 16 May 2014 amending Regulation (EC) No 401/2006 as regards methods of sampling of large lots, spices and food supplements, performance criteria for T-2, HT-2 toxin and citrinin and screening methods of analysis (Text with EEA relevance).

Footnotes

f1: Ref: M. Thompson and R. Wood, Accred. Qual. Assur., 2006, 10, p. 471-478.