Regulation (EU) 2017/625 of the European Parliament and of the CouncilShow full title

ANNEX III U.K. CHARACTERISATION OF METHODS OF ANALYSIS

1.

Methods of analysis and measurement results should be characterised by the following criteria:

(a)

accuracy (trueness and precision),

(b)

applicability (matrix and concentration range),

(c)

limit of detection,

(d)

limit of quantification,

(e)

precision,

(f)

repeatability,

(g)

reproducibility,

(h)

recovery,

(i)

selectivity,

(j)

sensitivity,

(k)

linearity,

(l)

measurement uncertainty,

(m)

other criteria that may be selected as required.

2.

The precision values referred to in point 1(e) shall either be obtained from a collaborative trial which has been conducted in accordance with an internationally recognised protocol on collaborative trials (e.g. ISO 5725 ‘Accuracy (trueness and precision) of measurement methods and results’) or, where performance criteria for analytical methods have been established, be based on criteria compliance tests. The repeatability and reproducibility values shall be expressed in an internationally recognised form (e.g. the 95 % confidence intervals as defined by ISO 5725 ‘Accuracy (trueness and precision) of measurement methods and results’). The results from the collaborative trial shall be published or freely available.

3.

Methods of analysis which are applicable uniformly to various groups of commodities should be given preference over methods which apply only to individual commodities.

4.

In situations where methods of analysis can only be validated within a single laboratory, those methods should be validated in accordance with internationally accepted scientific protocols or guidelines or, where performance criteria for analytical methods have been established, be based on criteria compliance tests.

5.

Methods of analysis adopted under this Regulation should be edited in the standard layout for methods of analysis recommended by the ISO.