Division 2.6 Analytical methods

F1Competent authorities shall evaluate the analytical methods proposed for post-registration control and monitoring purposes, to determine:

1. 2.6.1.

   for formulation analysis:

   the nature and quantity of the active substance(s) in the plant protection product and, where appropriate, any toxicologically, ecotoxicologically or environmentally significant impurities and co-formulants.

   This evaluation shall take into consideration the following information:

   1. (i)

      the data on analytical methods as provided for in the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof;

   2. (ii)

      the data on analytical methods as provided for in the Annex to Regulation (EU) No 545/2011 and in particular:

      • the specificity and linearity of the proposed methods,

      • the importance of interferences,

      • the precision of the proposed methods (intralaboratory repeatability and interlaboratory reproducibility);

   3. (iii)

      the limit of detection and determination of the proposed methods for impurities.

2. 2.6.2.

   for residue analysis:

   the residues of the active substance, metabolites, breakdown or reaction products resulting from authorised uses of the plant protection product and which are of toxicological, ecotoxicological or environmental significance.

   This evaluation shall take into consideration the following information:

   1. (i)

      the data on analytical methods as provided for in the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof;

   2. (ii)

      the data on analytical methods as provided for in the Annex to Regulation (EU) No 545/2011 and in particular:

      • the specificity of the proposed methods,

      • the precision of the proposed methods (intralaboratory repeatability and interlaboratory reproducibility),

      • the recovery rate of the proposed methods at appropriate concentrations;

   3. (iii)

      the limit of detection of the proposed methods;

   4. (iv)

      the limit of determination of the proposed methods.