Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (repealed)

[F1 Introduction U.K.

(i)

The information provided, taken together with that provided for one or more preparations containing the active substance, must be sufficient to permit an evaluation to be made as to the risks for man, arising from residues of the active substance and relevant metabolites, degradation and reaction products remaining in food. In addition, the information provided must be sufficient to:

• permit a decision to be made as to whether, or not, the active substance can be included in Annex I,

• specify appropriate conditions or restrictions to be associated with any inclusion in Annex I.

(ii)

A detailed description (specification) of the material used, as provided under Section 1, point 11 must be provided.

(iii)

Studies should be performed according to the guidance available on regulatory testing procedures for residues of plant protection products in food (2) .

(iv)

Where relevant, data should be analyzed using appropriate statistical methods. Full details of the statistical analysis should be reported.

(v)

Stability of residues during storage.

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 (six months in the case of radio-labelled material).

Studies with non-radio-labelled substances should be carried out with representative substratets and preferably on samples from treated crops or animals with incurred residues. Alternatively, if this is not possible, aliquots of prepared control samples should 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 and 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

F1 Substituted by Commission Directive 96/68/EC of 21 October 1996 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance).

(1)

Substance within the meaning of the definition of Article 2, point 3.

(2)

[F1 Guidance under development.]

Textual Amendments

F1 Substituted by Commission Directive 96/68/EC of 21 October 1996 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance).