Assessment of the Safety of Genetically Modified COT102 Cotton for Food and Feed Uses (RP2148)

The Food Standards Agency and Food Standards Scotland (FSA/FSS) received an application from Syngenta under assimilated regulation No. 1829/2003 for COT102 cotton. COT102 cotton has been modified by the addition of Vip3Aa19, an insecticidal protein from Bacillus thuringiensis , and APH4, which provides resistance to hygromycin and is used as an antibiotic resistance marker. The molecular characterisation of COT102 cotton confirmed the presence of a single transgenic insert, and bioinformatics analyses of this insert raised no safety concerns. Transgenic protein expression levels were determined and did not cause safety concerns. Genetic stability and phenotypic stability of the transgenic insert was also confirmed. The comparative assessment of COT102 cotton was deemed to be appropriate, and did not raise safety concerns. Studies on the Vip3Aa19 and APH4 proteins as expressed in COT102 cotton identified no safety concerns regarding toxicity or allergenicity, and no evidence was found that the genetic modification would change the overall allergenicity of COT102 cotton. The FSA/FSS agreed with the positive opinion of EFSA, and concluded that COT102 cotton is as safe as its conventional counterpart, with respect to its potential effects on human and animal health. This assessment represents the opinion of FSA and FSS.