# Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs (Text with EEA relevance), Division 4.3.1.2: ‘ Fitness-for-purpose ’ approach

Extent: E+W+S+N.I.

For in-house validated methods, as an alternative, a ‘fitness-for-purpose’ approach 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 = LOD/2 2 + α × 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

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Source: https://www.legislation.gov.uk/eur/2006/401/annex/II/division/4/division/4.3/division/4.3.1/division/4.3.1.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2006-401/annex-II/division-4/division-4.3/division-4.3.1/division-4.3.1.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.