Italia
The GMO Panel has previously assessed genetically modified (GM) cotton DAS‐24236‐5 × DAS‐21Ø23‐5 and concluded that it is as safe as its conventional counterpart and other appropriate comparators with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 17 November 2020, the European Commission requested EFSA to evaluate new DNA sequence information and updated bioinformatics data for cotton DAS‐24236‐5 × DAS‐21Ø23‐5 and to indicate whether the conclusions of the GMO Panel on the previously assessed cotton DAS‐24236‐5 × DAS‐21Ø23‐5 remain valid. The new sequence data of DAS‐24236‐5 showed the change of one nucleotide that results in one amino acid substitution, in the newly expressed Cry1F (synpro_L620Q) compared to the sequence originally reported. The GMO Panel concludes that this amino acid substitution in the protein is a mutation. Nonetheless with the exception of the bioinformatics analysis, the studies performed for the risk assessment of Cry1F in cotton DAS‐24236‐5 × DAS‐21Ø23‐5 remain valid. In addition, the new sequencing data showed a change in one nucleotide in the 5′ flanking region of DAS‐21Ø23‐5 compared to the original sequence reported on the stack cotton DAS‐24236‐5 × DAS‐21Ø23‐5. The bioinformatic analyses of the newly sequenced DAS‐21Ø23‐5 event in the stack DAS‐24236‐5 × DAS‐21Ø23‐5 shows that the nucleotide difference is in the 5′ flanking region outside the ORFs that span the 5′ junction and is therefore not considered further in the safety assessment. Based on the information provided, the GMO Panel concludes that the corrected sequence does not give rise to any safety concerns, and therefore, the original risk assessment of cotton DAS‐24236‐5 × DAS‐21Ø23‐5 remains valid.
