Division 5.1.1 Methods for the analysis of the plant protection product

Methods shall be provided, with a full description, for the determination of:

1. (a)

   active substance and/or variant in the plant protection product;

2. (b)

   relevant impurities identified in the technical material or which may be formed during manufacture of the plant protection product or from degradation of the plant protection product during storage;

3. (c)

   relevant co-formulants or components of co-formulants, where required by the national competent authorities.

In the case of a plant protection product containing more than one active substance and/or variant a method capable of determining each, in the presence of the other, shall be provided. If a combined method is not submitted, the technical reasons shall be stated.

The applicability of CIPAC methods shall be assessed and reported. In case of use of a CIPAC method, further validation data shall not be required, but example chromatograms shall be submitted, where available.

The specificity of the methods shall be determined and reported. In addition, the extent of interference by other substances present in the plant protection product (such as impurities or co-formulants), shall be determined.

The linearity of methods shall be determined and reported. The calibration range shall extend (by at least 20 %) beyond the highest and lowest nominal content of the analyte in relevant analytical solutions. Either duplicate determinations at three or more concentrations or single determinations at five or more concentrations shall be made. The equation of the calibration line and the correlation coefficient shall be reported and a typical calibration plot shall be submitted. In cases where a non-linear response is used, this shall be justified by the applicant.

The precision (repeatability) of the methods shall be determined and reported. A minimum of five replicate sample determinations shall be made, and the mean, the relative standard deviation and the number of determinations shall be reported. The accuracy of the methods shall be determined on at least two representative samples at levels appropriate to the material specification. The mean and the relative standard deviation of the recoveries shall be reported.

For relevant impurities and, where necessary, for relevant co-formulants the limit of quantification (LOQ) shall be determined and reported and shall be at a concentration of analyte, which is of toxicological or environmental significance, or at the concentration which is formed during storage of the product, where relevant.