Division 1.5.4 Conclusion of the allergenicity assessment

The conclusion of the allergenicity assessment shall indicate:

1. (a)

   whether the novel protein(s) is likely to be allergenic;

2. (b)

   whether the genetically modified food or feed is likely to be more allergenic than its conventional counterpart.

When there is a likelihood of increased allergenicity due to the genetic modification, the genetically modified food or feed shall be further characterised in the light of its anticipated intake (see Section 2). The applicant shall propose appropriate conditions for placing on the market (such as post-market monitoring and labelling).