Division 1.9 Specification of purity of the active substance in g/kg

The minimum content in g/kg of pure active substance in the manufactured material used for production of plant protection products, shall be reported. A justification shall be provided for the minimum content proposed in the specification; this shall include a statistical analysis of the data on at least five representative batches, as referred to in point 1.11. Additional supporting data may be provided to further justify the technical specification.

Where the required information is provided for a pilot plant production system, that information shall again be provided once industrial scale production methods and procedures have stabilised. Where available, industrial scale data shall be provided before approval under Regulation (EC) No 1107/2009. Where data on industrial scale production are not available, a justification shall be provided.

If the active substance is manufactured as technical concentrate (TK), the minimum and maximum content of the pure active substance shall be given, along with its content in the theoretical dry weight material.

If the active substance is a mixture of isomers, the ratio or the ratio range of the content of isomers shall be provided. The relative biological activity of each isomer, both in terms of efficacy and toxicity, shall be reported.

For plant extracts, a different approach may be taken if adequately justified.