ANNEX

PART ACHEMICAL PLANT PROTECTION PRODUCTS

SECTION 5Analytical methods

5.1.Methods used for the generation of pre-authorisation data

5.1.2.Methods for the determination of residues

Methods shall be submitted, with a full description, for the determination of non-isotope-labelled residues in all areas of the dossier, as set out in detail in the following points:

  1. (a)

    in soil, water, sediment, air and any additional matrices used in support of environmental fate studies;

  2. (b)

    in soil, water and any additional matrices used in support of efficacy studies;

  3. (c)

    in feed, body fluids and tissues, air and any additional matrices used in support of toxicology studies;

  4. (d)

    in body fluids, air and any additional matrices used in support of operator, worker, resident and bystander exposure studies;

  5. (e)

    in or on plants, plant products, processed food commodities, food of plant and animal origin, feed and any additional matrices used in support of residues studies;

  6. (f)

    in soil, water, sediment, feed and any additional matrices used in support of ecotoxicology studies;

  7. (g)

    in water, buffer solutions, organic solvents and any additional matrices resulting from the physical and chemical properties tests.

The specificity of the methods shall be determined and reported. Validated confirmatory methods shall be submitted if appropriate.

The linearity, recovery and precision (repeatability) of methods shall be determined and reported.

Data shall be generated at the LOQ and either the likely residue levels or ten times the LOQ. The LOQ shall be determined and reported for each component in the residue definition.