Division Introduction

The provisions of this Section cover analytical methods used for the generation of pre-authorisation data and required for post-authorisation control and monitoring purposes.

Descriptions of methods shall be provided and include details of equipment, materials and conditions used.

On request, the following shall be provided:

1. (a)

   analytical standards of the purified active substance and of the plant protection product;

2. (b)

   samples of the active substance as manufactured;

3. (c)

   analytical standards of relevant metabolites and all other components included in all monitoring residue definitions;

4. (d)

   samples of reference substances for the relevant impurities.

In addition, the standards referred to in points (a) and (c) shall, where possible, be made commercially available and, on request, the distributing company shall be named.