The European Food Safety Authority (EFSA) has given a positive safety assessment to the application EFSA-GMO-NL-2011-9 under Regulation (EC) No 1829/2003 from Bayer CropScience AG.
The application from Bayer is asking for authorisation of insect-resistant and herbicide-tolerant genetically modified (GM) cotton GHB614 × LLCotton25 × MON 15985 (Unique Identifier BCS-GHØØ2-5 × ACS-GHØØ1-3 × MON-15985-7). The scope of the application is for import, processing, and food and feed uses of cotton GHB614 × LLCotton25 × MON 15985 within the European Union (EU) but excludes cultivation in the EU.
In delivering its scientific opinion, the GMO Panel considered the data available on the single events, the information presented in application EFSA‐GMO‐NL‐2011‐94, additional information provided by the applicant, the scientific comments submitted by the Member States and relevant scientific publications. The three‐event stack cotton GHB614 × LLCotton25 × MON 15985 was produced by conventional crossing to combine three single cotton events: GHB614, expressing the 2mEPSPS protein for tolerance to glyphosate‐based herbicides; LLCotton25, expressing the PAT protein for tolerance to glufosinate‐ammonium‐based herbicides; and MON 15985, expressing the Cry1Ac and Cry2Ab2 proteins which confer resistance to certain lepidopteran pest and the NPTII and GUS proteins which were used as selectable markers.
Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of cotton events GHB614, LLCotton25 and × MON 15985 in the three‐event stack cotton did not give rise to issues regarding food and feed safety and nutrition. The combination of the newly expressed proteins in the three‐event stack cotton did not raise concerns for human and animal health. The toxicological and nutritional assessment identified no concern related to the increased levels of gossypol, dihydrosterculic acid and α‐tocopherol. The nutritional impact of food and feed derived from cotton GHB614 × LLCotton25 × MON 15985 is not expected to differ from that of food and feed derived from the non‐GM comparator.
Considering the combined events, the outcome of the comparative analysis, the routes of exposure and limited exposure levels, the GMO Panel concludes that this three‐event stack cotton would not raise safety concerns in the case of accidental release of viable GM cottonseeds into the environment.
In conclusion, the GMO Panel considers that the information available for cotton GHB614 × LLCotton25 × MON 15985 addresses the scientific comments raised by Member States and that cotton GHB614 × LLCotton25 × MON 15985, as described in this application, is as safe as the non‐GM comparator with respect to potential effects on human and animal health and the environment in the context of the scope of this application.
Given that no safety concerns were identified on food/feed derived from cotton GHB614 × LLCotton25 × MON 15985, the GMO Panel considers that post‐market monitoring of these products is not necessary. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton GHB614 × LLCotton25 × MON 15985.