F1ANNEX VI

Annotations:

F2PART IIUNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF PLANT PROTECTION PRODUCTS CONTAINING MICRO-ORGANISMS

Annotations:

B.EVALUATION

2.Specific principles

2.8.Effects on and exposure of non-target organisms

2.8.1.Member States shall evaluate the possibility of exposure of and effects on terrestrial wildlife (non-domestic birds, mammals and other terrestrial vertebrates).

2.8.1.1.A micro-organism may give rise to risks because of its potential to infect and multiply in avian and mammalian host systems. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism:

  1. (a)

    its mode of action,

  2. (b)

    other biological properties,

  3. (c)

    studies on mammalian toxicity, pathogenicity and infectivity,

  4. (d)

    studies on avian toxicity, pathogenicity and infectivity.