Division (vii)

It may be necessary to conduct separate studies for relevant metabolites (especially toxins), where these products can constitute a relevant risk to non-target organisms and where their effects cannot be evaluated by the available results relating to the micro-organism. Before such studies are performed, the applicant shall seek agreement of the competent authorities on whether such studies need to be performed and, if so, the type of study to be conducted. The information from Sections 5, 6 and 7 has to be taken into account.