Commission Regulation (EC) No 273/2008 (repealed)Show full title

PROCEDURE APPLICABLE WHEN THE RESULTS OF AN ANALYSIS ARE DISPUTED (CHEMICAL ANALYSIS)

1. A further analysis is carried out in another laboratory approved by the competent authority using the relevant method at the request of the manufacturer, provided that sealed duplicate samples of the product are available and have been stored appropriately with the competent authority. The request is expressed within seven working days after notification of the results of the first analysis. The analysis is carried out within 21 working days after receipt of the request. The competent authority will send these samples to a second laboratory at the request and the expense of the manufacturer. The laboratory must be authorized to carry out official analyses and must have proven competence for the relevant analysis under question.

2. The expanded uncertainties (k = 2) of the mean of the repeated measurements in laboratory 1 and of the mean of the repeated measurements in laboratory 2 are

3. and resp., where is the repeatability standard deviation and is the reproducibility standard deviation of the relevant method. If the final result y of measurement in the laboratories is calculated using a formula of the form , , or the usual procedures for combining standard deviations in such cases must be followed in order to obtain the uncertainty.

4. In order to test whether the results of the two laboratories are in compliance with the reproducibility standard deviation of the method, the expanded uncertainty of the difference is calculated:

5. If the absolute value of the difference of the laboratory means, , is not larger than its uncertainty ,

,

the results of the two laboratories are in compliance with the reproducibility standard deviation and the arithmetic mean of the two laboratory means,

,

is reported as the final result. Its expanded uncertainty is

.

The consignment is rejected as being not in compliance with an upper legal limit UL if

;

otherwise it is accepted as being in compliance with UL.

The consignment is rejected as being not in compliance with a lower legal limit LL if

;

otherwise it is accepted as being in compliance with LL.

If the absolute value of the difference of the laboratory means, , is larger than its uncertainty ,

,

The results of the two laboratories are not in compliance with the reproducibility standard deviation.

In this case the consignment is rejected as non-compliant if the second analysis confirms the first. Otherwise, the consignment is accepted as compliant.

The final result must be notified by the competent authority to the manufacturer as soon as possible. The costs of the second analysis are to be borne by the manufacturer, if the consignment is rejected.