Division 1.4.5 Conclusion of the toxicological assessment

The conclusion of the toxicological assessment shall indicate whether:

1. (a)

   potential adverse effects identified in other parts of the safety assessment have been confirmed or discarded;

2. (b)

   the available information on the newly expressed protein(s) and other new constituents resulting from the genetic modification gives indications of potential adverse effects in particular, whether and at which dose levels adverse effects were identified in specific studies;

3. (c)

   the information on natural constituents of which the levels are different from those in its conventional counterpart provides indications of potential adverse effects, in particular, whether and at which dose levels adverse effects were identified in specific studies;

4. (d)

   adverse effects have been identified from the studies made on the whole genetically modified food and feed and at which dose levels.

The applicant shall evaluate the result of the toxicological assessment in the light of anticipated intake of the genetically modified food and feed (see Section 2).