Division 2.8 Effects on and exposure of non-target organisms

Information on the ecology of the micro-organism and effects on the environment should be assessed as well as possible exposure levels and the effects of its relevant metabolites/toxins. An overall assessment of the environmental risks that the plant protection product may cause, taking into account the normal levels of exposure to micro-organisms both in the environment as well as in the body of organisms, is necessary.

Member States shall evaluate the possibility of exposure of non-target organisms under the proposed conditions of use and if this possibility exists they shall evaluate the risks arising for the non-target organisms concerned.

Where applicable, an assessment of infectivity and pathogenicity is necessary, unless it can be justified that non-target organisms will not be exposed.

To assess the possibility of exposure the following information should also be taken into consideration:

1. (a)

   the survival of the micro-organism in the respective compartment,

2. (b)

   its ecological niche,

3. (c)

   the natural background level of the micro-organism, where it is indigenous,

4. (d)

   information on fate and behaviour in the various parts of the environment,

5. (e)

   where relevant, other authorised uses of the plant protection product in the area of envisaged use containing the same active substance or which give rise to the same residues.