Division Test conditions

Studies with non-radio-labelled active substances shall be carried out with representative substrates. They may be either performed on samples from treated crops or animals with incurred residues or by fortification experiments. In the latter case, aliquots of prepared control samples shall be spiked with a known amount of chemical before storage under normal storage conditions.

The studies shall address stability of individual components of the residue definition relevant to risk assessment, which may require spiking different samples with different analytes. In case of different analytical targets (for example targeting either single compounds or a common moiety) more than one set of storage stability data may be needed.

The duration of the stability studies shall be suitable to address the length over which the samples or extracts have been stored in the corresponding studies.

Detailed information with respect to the sample preparation and storage conditions (temperature and duration) of samples and extracts shall be submitted. Where the degradation during storage is significant (more than 30%) a change in the storage conditions or not storing the samples prior to analysis shall be considered. All studies where unsatisfactory storage conditions were used shall be repeated.

Storage stability data using sample extracts shall also be required unless samples are analysed within 24 hours of extraction.

Results shall be presented as absolute values in mg/kg and not adjusted by recovery, as well as percentage of nominal spike value.