Division 1.4.4 Testing of the whole genetically modified food and feed

The applicant shall primarily base its risk assessment of the genetically modified food and feed on molecular characterisation, comparative agronomic, phenotypic and comprehensive compositional analysis, and the toxicological evaluation of the identified intended and unintended effects, including a 90-day feeding study in rodents with whole genetically modified food/feed as specified in Section 1.4.4.1. Under the circumstances set out in points 1.4.4.2 and 1.4.4.3 of this Section, additional specific toxicological studies with the whole genetically modified food and feed shall be carried out.