Division 6.2.2 Viable residuesF1

If the information submitted in accordance with point 6.1 suggests persistence of relevant amounts of the micro-organism in or on treated products, food or feed, possible effects on humans and/or animals must be investigated, unless it can be justified from Section 5, that the micro-organism and its metabolites and/or degradation products are not hazardous to humans in the concentrations and of the nature that could occur as a result of authorised use.

In accordance with Regulation (EC) No 1107/2009, the conclusion concerning the difference between natural concentrations and an elevated concentration due to treatment with the micro-organism, is to be based on experimentally obtained data, and not on extrapolations or calculations using models.

The persistence of viable residues needs special attention if infectiveness or pathogenicity to mammals have been found in points 2.3 and 2.5 or in Section 5 and/or if any other information suggests a hazard to consumers and/or workers. In this case the competent authorities may require studies similar to those provided for in Part A.

Before performing such studies, the applicant shall seek agreement of the competent authorities on the type of study to be performed.