ANNEX IU.K.
In Annex I to Directive 2001/22/EC, point 5 is replaced by the following:
‘5.COMPLIANCE OF THE LOT OR SUBLOT WITH THE SPECIFICATION
The control laboratory shall analyse the laboratory sample for enforcement at least in two independent analyses, and calculate the mean of the results.
The lot is accepted if the mean does not exceed the respective maximum level as laid down in Regulation (EC) No 466/2001, taking into account the expanded measurement uncertainty and correction for recovery (1).
The lot is rejected if the mean exceeds the respective maximum level beyond reasonable doubt, taking into account the expanded measurement uncertainty and correction for recovery.
The present interpretation rules are of application for the analytical result obtained on the sample for official control. In case of analysis for defence or referee purposes, the national rules apply.’
ANNEX IIU.K.
Annex II to Directive 2001/22/EC is amended as follows:
In point 3. ‘Method of analysis to be used by the laboratory and laboratory control requirements’, the following point 3.3.3. is inserted after Table 4:
‘3.3.3.Performance Criteria — Uncertainty Function Approach
However, an uncertainty approach may also be used to assess the suitability of the method of analysis to be used by the laboratory. The laboratory may use a method which will produce results within a maximum standard uncertainty. The maximum standard uncertainty can be calculated using the following formula:
where:
Uf is the maximum standard uncertainty
LOD is the limit of detection of the method
C is the concentration of interest
α is a numeric factor to be used depending on the value of C. The values to be used are given in the table below:
| 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 |
and U is the expanded uncertainty, using a coverage factor of 2 which gives a level of confidence of approximately 95 %.
If an analytical method provides results with uncertainty measurements less than the maximum standard uncertainty the method will be equally suitable to one which meets the performance characteristics given above.’
Point 3.4. is replaced by the following:
‘3.4.Estimation of the analytical trueness, recovery calculations and reporting of results
Wherever possible the trueness of analysis shall be estimated by including suitable certified reference materials in the analysis.
The analytical result is to be reported corrected or uncorrected for recovery. The manner of reporting and the level of recovery must be reported.
The analyst should note the “European Commission Report on the relationship between analytical results, the measurement of uncertainty, recovery factors and the provisions in EU food legislation”(1).
The analytical result has to be reported as x +/– U whereby x is the analytical result and U is the measurement uncertainty.
REFERENCES
(1)European Commission Report on the relationship between analytical results, the measurement of uncertainty, recovery factors and the provisions in EU food legislation, 2004
(http://europa.eu.int/comm/food/food/chemicalsafety/contaminants/sampling_en.htm).’