# Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the control of the levels of trace elements and processing contaminants in foodstuffs (Text with EEA relevance), Division C.3.3.2: ‘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 combined standard measurement uncertainty (u) less than the maximum standard measurement uncertainty calculated using the formula below:
Uf=LOD∕22+αC2
where:
Uf is the maximum standard measurement uncertainty (μg/kg).
LOD is the limit of detection of the method (μg/kg). The LOD must meet the performance criteria set in point C.3.3.1 for the concentration of interest.
C is the concentration of interest (μg/kg);
α is a numeric factor to be used depending on the value of C. The values to be used are given in Table 10.
Table 10
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
The analyst shall note the ‘Report on the relationship between analytical results, measurement uncertainty, recovery factors and the provisions of EU food and feed legislation’.

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Source: https://www.legislation.gov.uk/eur/2007/333/annex/part/C/division/C.3/division/C.3.3/division/C.3.3.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2007-333/annex/part-C/division-C.3/division-C.3.3/division-C.3.3.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.