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Scientific Opinion on application EFSA-GMO-RX-MON1445 for renewal of the authorisation for continued marketing of cottonseed oil, food additives, feed materials and feed additives produced from cotton MON 1445 that were notified as existing products under Articles 8(1)(a), 8(1)(b) and 20(1)(b) of Regulation (EC) No 1829/2003 from Monsanto

This scientific opinion evaluates the risk assessment for the authorisation for continued marketing of genetically modified herbicide tolerant cotton MON 1445 for food and feed produced from it. Cotton MON 1445 contains single copies of functional CP4 epsps and nptII expression cassettes and an aadA gene as non-functional element. Stability of the inserted DNA was confirmed over several generations. Bioinformatic analyses and levels of recombinant proteins did not reveal safety issues. No biologically relevant differences were identified in the compositional, phenotypic and agronomic characteristics of cotton MON 1445 in comparison to its conventional counterpart and its composition fell within the range of non-GM cotton varieties, except for CP4 EPSPS and NPTII proteins. No toxicity and allergenicity issues were identified regarding the newly expressed protens. Products from cotton MON 1445 do not contain viable plant parts. Insert structure in cotton MON 1445 may facilitate the stabilisation of the nptII gene in plasmids of environmental bacteria through double homologous recombination. However, considering the expected low frequency of gene transfer from cotton MON 1445 to bacteria compared to that between bacteria, and the very low exposure to DNA from cotton MON 1445, the EFSA GMO Panel concludes that the contribution of horizontal gene transfer to the environmental prevalence of nptII genes is negligible. Potential interactions of cotton MON 1445 with non-target organisms and the abiotic environment were not considered to be an issue because of low exposure levels. A post-market environmental monitoring plan is not required. The EFSA GMO Panel concludes that the information available for cotton MON 1445 addresses the questions raised by the Member States and that MON 1445-derived products are as safe as products derived from the conventional counterpart in the context of their intended uses.



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