Division 2.2 Risk assessment of genetically modified food and feed containing stacked transformation events

For the risk assessment of genetically modified food and feed containing stacked transformation events obtained by conventional crossing of genetically modified plants containing one or several transformation event(s), the applicant shall provide a risk assessment of each single transformation event or, in accordance with Article 3(6) of this Regulation, refer to already submitted application(s). The risk assessment of genetically modified food and feed containing stacked transformation events shall also include an assessment of the following aspects:

1. (a)

   stability of the transformation events;

2. (b)

   expression of the transformation events;

3. (c)

   potential synergistic or antagonistic effects resulting from the combination of the transformation events shall be subject to an assessment in accordance with Sections 1.4 (Toxicology), 1.5 (Allergenicity) and 1.6 (Nutritional assessment).

For genetically modified food and feed containing, consisting of or produced from genetically modified plants, whose cultivation is associated with the production of genetically modified material containing various subcombinations of transformation events (segregating crops), the application shall include all subcombinations independently of their origin which have not yet been authorised. In such a case, the applicant shall provide a scientific rationale justifying that there is no need to provide experimental data for the concerned subcombinations or, in the absence of such scientific rationale, provide the experimental data.

For genetically modified food and feed containing, consisting of or produced from genetically modified plants, the cultivation of which does not lead to the production of genetically modified material containing various combinations of transformation events (non-segregating crops), the application shall only cover the combination which is to be placed on the market.

The rules set out in this Section apply mutatis mutandis to transformation events which are combined by other means such as co- and retransformation.