Division 4.2 Methods for post-approval control and monitoring purposes

Methods, with a full description, shall be submitted for:

1. (a)

   the determination of all components included in the monitoring residue definition as submitted in accordance with the provisions of point 6.7.1 in order to enable F1competent authorities to determine compliance with established maximum residue levels (MRLs); they shall cover residues in or on food and feed of plant and animal origin;

2. (b)

   the determination of all components included for monitoring purposes in the residue definitions for soil and water as submitted in accordance with the provisions of point 7.4.2;

3. (c)

   the analysis in air of the active substance and relevant breakdown products formed during or after application, unless the applicant shows that exposure of operators, workers, residents or bystanders is negligible;

4. (d)

   the analysis in body fluids and tissues for active substances and relevant metabolites.

As far as practicable these methods shall employ the simplest approach, involve the minimum cost, and require commonly available equipment.

The specificity of the methods shall be determined and reported. It shall enable all components included in the monitoring residue definition to be determined. Validated confirmatory methods shall be submitted if appropriate.

The linearity, recovery and precision (repeatability) of methods shall be determined and reported.

Data shall be generated at the LOQ and either the likely residue levels or ten times the LOQ. The LOQ shall be determined and reported for each component included in the monitoring residue definition.

For residues in or on food and feed of plant and animal origin and residues in drinking water, the reproducibility of the method shall be determined by means of an independent laboratory validation (ILV) and reported.