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

Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (Text with EEA relevance)

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ANNEX IIIU.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.

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