Division Test conditions

The intended method of application (such as seed treatment, soil/foliar spraying, dipping, fogging) and the properties of the active substance (such as systemic properties or volatility) shall be taken into account when planning metabolism studies. Metabolism studies have to involve crops from different categories of crops in which plant protection products containing the active substance in question would be used. For this purpose crops shall be considered as falling into one of the following categories:

1. (a)

   fruit (code F);

2. (b)

   root crops (code R);

3. (c)

   leafy crops (code L);

4. (d)

   cereal/grass crops (code C/G);

5. (e)

   pulses and oilseeds (code P/O);

6. (f)

   miscellaneous.

The category ‘miscellaneous’ shall only be used on a case by case basis.

A metabolism study shall be submitted for each type of crop group for which use is proposed. In order to extrapolate results from metabolism studies with an active substance to all crop groups, metabolism studies on a minimum of three representative crops (from the different crop groups except ‘miscellaneous’) shall be conducted. If the results of these three studies indicate a comparable metabolic route (qualitatively and to a lesser extent quantitatively), then additional studies shall not be needed. If the results from the available studies from three of these categories indicate that the route of degradation is not similar in all three categories, studies from the remaining categories except ‘miscellaneous’ shall be provided.

If authorisation is sought for one crop group only, metabolism studies in one crop from that crop group shall be sufficient as long as the crop is truly representative of the crop group and the metabolic pathway is elucidated.

The studies shall reflect the intended use pattern of the active ingredient such as foliar, soil/seed or post-harvest treatments. If, for instance, three studies have been conducted using foliar application and at a later date soil application (such as seed treatment, granular or soil drench) is proposed, then at least one additional study reflecting soil application shall be conducted. The applicant shall discuss with the national competent authorities the possible replacement of a foliar study with a post-harvest study.

An evaluation of the results from different studies shall be submitted on:

1. (a)

   the site of uptake (for example via leaves or roots);

2. (b)

   the formation of metabolites and breakdown products;

3. (c)

   the distribution of residues between relevant parts of the crop at harvest (with particular emphasis on food and feed);

4. (d)

   the metabolic pathways.

If studies show that the active substance or relevant metabolites or breakdown products are not taken up by the crop, a rationale shall be given.