Jul. 26, 2018
The European Food Safety Authority (EFSA) has given a positive safety assessment to the application EFSA‐GMO‐NL‐2014‐122 under Regulation (EC) No 1829/2003 from Bayer CropScience N.V.
The application from Bayer CropScience is asking for the authorisation of insect‐resistant and herbicide‐tolerant genetically modified (GM) cotton GHB614 × T304‐40 × GHB119. The scope of application EFSA‐GMO‐NL‐2014‐122 is for import, processing and food and feed uses but excludes cultivation in the European Union (EU) and covers the three‐event stack cotton GHB614 × T304‐40 × GHB119 in cotton speciesGossypium hirsutum and Gossypium barbadense.
The three‐event stack cotton GHB614 × T304‐40 × GHB119 was produced by conventional crossing to combine three single events: GHB614 (expressing the modified 5‐enolpyruvyl‐shikimate‐3‐phosphate synthase (2mEPSPS) protein)), T304‐40 (expressing Cry1Ab and phosphinothricin acetyltransferase (PAT)) proteins) and GHB119 (expressing Cry2Ae and PAT proteins) to confer resistance to certain lepidopteran pests and tolerance to glyphosate‐ and glufosinate ammonium‐based herbicides.
For application EFSA‐GMO‐NL‐2014‐122, the previous assessment of the three single cotton events (GHB614, T304‐40 and GHB119) provided the basis to evaluate the three‐event stack cotton. Cotton GHB614, T304‐40 and GHB119 were previously assessed by the GMO Panel and no safety concerns were identified. No safety issue was identified by updated bioinformatics analyses nor reported by the applicant for any of the three single cotton events since the publication of the respective scientific opinions. In line with Regulation (EU) 503/2013, the GMO Panel assessed the three 90‐day toxicity studies on the whole food/feed from the single events GHB614, T304‐40 and GHB119 and concludes that no adverse effects were noted in these studies. Consequently, the GMO Panel considers that its previous conclusions on the safety of the single cotton events remain valid.
The GMO Panel concludes that cotton GHB614 × T304‐40 × GHB119, as described in this application, is as safe as its comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.