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Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed)
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If may be necessary to perform studies on the stability of residues during storage. Provided samples are frozen within generally 24 hours after sampling and unless a compound is otherwise known to be volatile or labile, data are not normally required for samples extracted and analysed within 30 days from sampling (6 months in the case of radio-labelled material).
Studies with non-radio-labelled substances shall be carried out with representative substrates and preferably on samples from treated crops or animals with incurred residues. Alternatively, if this is not possible, aliquots of prepared control samples shall be spiked with a known amount of chemical before storage under normal storage conditions.
Where the degradation during storage is significant (more than 30 %) it may be necessary to change the storage conditions or not to store the samples prior to analysis and repeat any studies where the unsatisfactory storage conditions were used.
Detailed information with respect to the sample preparation and storage conditions (temperature and duration) of samples and extracts must be submitted. Storage stability data using sample extracts will also be required unless samples are analysed within 24 hours of extraction.]
Textual Amendments applied to the whole legislation
F1Repealed (subject to transitional measures in Arts. 3, 4) by 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.
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