Scientific Opinion on applications (EFSA-GMO-UK-2008-57 and EFSA-GMO-RX-MON15985) for the placing on the market of insect-resistant genetically modified cotton MON 15985 for food and feed uses, import and processing, and for the renewal of authorisation o

Abstract

Cotton MON 15985 was developed by biolistic transformation of cotton MON 531 to express Cry2Ab2 and GUS in addition to the Cry1Ac and NPTII proteins. Cry proteins in MON 15985 confer resistance to major lepidopteran cotton pests, whereas the GUS and NPTII proteins were used as markers during product development. Molecular characterisation of MON 15985 did not give rise to safety issues. The EFSA GMO Panel could not conclude on the potential occurrence of unintended effects for agronomic and phenotypic characteristics owing to data limitations. Compositional data gave no indication of unintended effects for which further assessment was needed. The Panel concludes that cotton MON 15985, as described in these applications, is as safe and nutritious as its conventional counterpart and other non-genetically modified varieties, and considers it unlikely that the overall allergenicity of the whole plant is changed. Environmental risk assessment was restricted to the exposure through faecal material from animals fed with cotton products of MON 15985 and its accidental spillage. Following a weight of evidence approach and considering the poor ability of cotton to survive outside cultivated land, despite the agronomic and phenotypic data limitations, the Panel concludes that there is very low likelihood of any adverse environmental impacts. The aadA and oriV sequences in MON 15985 may facilitate the stabilisation of nptII through double homologous recombination. However, considering the limited presence of intact DNA from MON 15985 in feed and the limited occurrence of horizontal transfer of DNA from plant material to bacteria, the Panel concludes that it is highly unlikely that nptII from MON 15985 will be transferred to bacteria. Since both EFSA-GMO-UK-2008-57 and EFSA-GMO-RX-MON15985 cover cotton MON 15985, the EFSA GMO Panel provides a single scientific opinion, valid for both applications.The EFSA GMO Panel evaluated cotton MON 15985 with reference to the scope and appropriate principles described in its guidance documents for the risk assessment of genetically modified (GM) plants and derived food and feed (EFSA, 2006a; EFSA GMO Panel, 2011a), environmental risk assessment (ERA) (EFSA GMO Panel, 2010a) and for renewal of authorisations of existing GMO products lawfully placed on the market (EFSA, 2006b). The scientific evaluation of the risk assessment included molecular characterisation of the inserted DNA and analysis of the expression of the corresponding proteins. An evaluation of the comparative analyses of compositional, agronomic and phenotypic characteristics was undertaken, and the safety of the newly expressed proteins and the whole food/feed was evaluated with respect to potential toxicity, allergenicity and nutritional wholesomeness. An evaluation of environmental impacts and the post-market environmental monitoring (PMEM) plan was also undertaken.The scope of applications EFSA-GMO-UK-2008-57 and EFSA-GMO-RX-MON15985 covers the MON 15985 event in cotton species Gossypium hirsutum L. and G. barba...

Assessment of genetically modified cotton GHB614 × LLCotton25 × MON 15985 for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2011‐94)

“…For cotton events GHB614 and LLCotton25, the GMO Panel concluded that there is no increased likelihood for HGT; for cotton event MON 15985, the GMO Panel concluded that there is increased likelihood of transfer of the antibiotic resistance gene nptII, but that MON 15985 material is highly unlikely to contribute to the environmental prevalence of this gene. No adverse effects on human and animal health and the environment are expected (EFSA, 2006b(EFSA, , 2009aEFSA GMO Panel, 2014a). New bioinformatic data 38 confirmed the previous conclusions.…”

“…This gene was only used as a selectable marker during the development of MON 15985. This gene is under the control of a prokaryotic promoter and it is therefore not expressed in parental line cotton MON 15985 (EFSA GMO Panel, 2011c, 2014a. (Lebrun et al, 2003) The amino acid sequence of the maize EPSPS enzyme was modified by two substitutions to render it tolerant to glyphosate.…”

Recommendations for Maximum Incorporation Rates of Whole Food in 90-Day Rat Feeding Studies

“…Feeding Studies Various forms of cottonseed (ground whole seed, whole flour, and processed meal) have been incorporated into diets and fed to rats at different incorporation rates. In a 90-day rat feeding study performed with ground whole cottonseed and reviewed in an EFSA Scientific Opinion [39], groups of 20 Sprague Dawley rats were fed diets containing 2 or 5 percent (w/w) ground GM cottonseed. Six additional groups were fed diets containing 5 percent (w/w) ground cottonseed from commercial non-GM cotton varieties.…”