Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance) (c. 283)

ANNEX U.K.

PART A U.K. CHEMICAL ACTIVE SUBSTANCES

SECTION 6 U.K. Residues in or on treated products, food and feed

6.1. Storage stability of residues U.K.

Studies concerning storage stability of residues shall investigate the stability of residues in plants, plant products and products of animal origin during storage prior to analysis.

Circumstances in which required U.K.

Provided that samples are frozen within 24 hours after sampling and unless a compound is otherwise known to be volatile or labile, stability data shall not be required for samples extracted and analysed within 30 days from sampling (six months in the case of radio-labelled material).

The stability of extracts shall be investigated if extracts are not analysed immediately.

Test conditions U.K.

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.