Division 3.3 The result of risk characterisation

In accordance with the requirements of Articles 4 and 16 of Regulation (EC) No 1829/2003, the applicant shall ensure that the final risk characterisation clearly demonstrates that:

1. (a)

   the genetically modified food and feed has no adverse effects on human and animal health;

2. (b)

   the genetically modified food does not differ from the food which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for the consumer;

3. (c)

   the genetically modified food does not mislead the consumer;

4. (d)

   the genetically modified feed does not harm or mislead the consumer by impairing the distinctive features of the animal products;

5. (e)

   the genetically modified feed does not differ from the feed which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for animals or humans.

The applicant shall clearly indicate what assumptions have been made during the risk assessment in order to predict the probability of occurrence and severity of adverse effect(s) in a given population, and the nature and magnitude of uncertainties associated with establishing these risks.

The applicant shall also include detailed information justifying the inclusion or not of a proposal for labelling in the application, in accordance with Article 13(2)(a), Article 13(3), Article 25(2)(c) and Article 25(3) of Regulation (EC) No 1829/2003.