Assessment of genetically modified cotton T304-40 × GHB119 × COT102 (application EFSA-GMO-BE-2018-155)

Genetically modified cotton T304-40 × GHB119 × COT102 was developed by crossing to combine three single events: T304-40, GHB119 and COT102. The three-event stack cotton expresses Cry1Ab, Cry2Ae, Vip3Aa19 and PAT/bar to confer herbicide tolerance and insect resistance. Furthermore, event COT102 expresses the antimicrobial APH4 protein used during its molecular development. The GMO Panel previously assessed the three single cotton events and did not identify safety concerns. Since then, no new data on the single cotton events were identified that would require modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment does not indicate interactions which would give rise to new food and feed safety and nutritional concerns. The GMO Panel concludes that three-event stack cotton, as described in this application, is as safe as its non-GM comparator and non-GM cotton varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of release of processed cotton T304-40 × GHB119 × COT102 or accidental spillage of viable GM cotton seeds, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton T304-40 × GHB119 × COT102. The GMO Panel concludes that three-event stack cotton is as safe as its non-GM comparator and the tested non-GM cotton varieties with respect to potential effects on human and animal health and the environment.