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Division 2.3.2.2 Precision of quantitative methods

United Kingdom

Original text. Later amendments are not shown.

The inter-laboratory coefficient of variation (CV) for the repeated analysis of a reference or fortified material, under reproducibility conditions, shall not exceed the level calculated by the Horwitz Equation. The equation is:

CV =  2 ( 1   –   0 , 5   l o g   C )

where C is the mass fraction expressed as a power (exponent) of 10 (e.g. 1 mg/g = 10-3). Examples are shown in the table 3.

Table 3

Examples for reproducibility CVs for quantitative methods at a range of analyte mass fractions

Mass fractionReproducibility CV(%)
(*)

For mass fractions lower than 100 μg/kg the application of the Horwitz Equation gives unacceptable high values. Therefore, the CVs for concentrations lower than 100 μg/kg shall be as low as possible.

1 μg/kgf1
10 μg/kg
100 μg/kg23
1 000 μg/kg (1 mg/kg)16

For analyses carried out under repeatability conditions, the intra-laboratory CV would typically be between one half and two thirds of the above values. For analyses carried out under within-laboratory reproducibility conditions, the within-laboratory CV shall not be greater than the reproducibility CV.

In the case of substances with an established permitted limit, the method shall achieve within-laboratory reproducibility not greater than the corresponding reproducibility CV at a concentration of 0,5 × the permitted limit.

Annotations

Footnotes

f1

(*)

For mass fractions lower than 100 μg/kg the application of the Horwitz Equation gives unacceptable high values. Therefore, the CVs for concentrations lower than 100 μg/kg shall be as low as possible.

Notes on Annex I

Textual amendments

F1

Replaced by virtue of 2003/181/EC: Commission Decision of 13 March 2003 amending Decision 2002/657/EC as regards the setting of minimum required performance limits (MRPLs) for certain residues in food of animal origin (Text with EEA relevance) (notified under document number C(2003) 764)