# Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (Text with EEA relevance), Division 2.6: Analytical methods

Extent: E+W+S+N.I.

The methods proposed must reflect the state of the article. The following criteria must be met in order to permit validation of the analytical methods proposed for post-registration control and monitoring purposes:
2.6.1.for formulation analysis:
the method must be able to determine and to identify the active substance(s) and where appropriate any toxicologically, ecotoxicologically or environmentally significant impurities and co-formulants;
2.6.2.for residue analysis:
(i)the method must be able to determine and confirm residues of toxicological, ecotoxicological or environmental significance;
(ii)the mean recovery rates should be between 70 % and 110 % with a relative standard deviation of ≤ 20 %;
(iii)the repeatability must be less than the following values for residues in foodstuffs:
Residue levelmg/kg
Differencemg/kg
Differencein %
0,01
0,005
50
0,1
0,025
25
1
0,125
12,5
> 1
12,5
Intermediate values shall be determined by interpolation from a log-log graph;
(iv)the reproducibility must be less than the following values for residues in foodstuffs:
Residue levelmg/kg
Differencemg/kg
Differencein %
0,01
0,01
100
0,1
0,05
50
1
0,25
25
> 1
25
Intermediate values are determined by interpolation from a log-log graph;
(v)in the case of residue analysis in treated plants, plant products, foodstuffs, feedingstuffs or products of animal origin, except where the MRL or the proposed MRL is at the limit of determination, the sensitivity of the methods proposed must satisfy the following criteria:
Limit of determination in relation to the proposed provisional MRL or MRL:
MRL(mg/kg)
limit of determination(mg/kg)
> 0,5
0,1
0,5 – 0,05
0,1 – 0,02
< 0,05
LMR × 0,5

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Source: https://www.legislation.gov.uk/eur/2011/546/annex/part/I/division/C/division/2/division/2.6 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-546/annex/part-I/division-C/division-2/division-2.6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.