Risk assessment of new sequencing information on genetically modified carnation FLO‐40685‐2

GMO, carnation, Dianthus caryophyllus, FLO-40685-2, nucleotide sequence, Directive 2001/18/EC
First published in the EFSA Journal
31 juillet 2018
20 juillet 2018

The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40685‐2 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40685‐2 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 7 November 2017, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for carnation FLO‐40685‐2 and to indicate whether the conclusions of the GMO Panel on the previously assessed GM carnation FLO‐40685‐2 remain valid. The new sequencing data indicated an additional three base pairs compared to the sequencing data originally provided: one base pair addition to the polyA tail of each of the two inserted flavonoid 3',5'–hydroxylase elements and one base pair addition to the sequence of one of the two D8 promoters in locus 1. These sequence differences are located outside the coding sequence for the newly expressed proteins and the base pairs described as differences in the new nucleic acid sequencing data for carnation FLO‐40685‐2 were reported to have been already present in the original plant material used for the risk assessment. Thus, with the exception of bioinformatics analyses, the studies performed for the risk assessment of GM carnation FLO‐40685‐2 remain valid. The new sequencing data and the bioinformatics analyses performed on the new sequence did not give rise to safety issues. Therefore, EFSA concludes that the original risk assessment of carnation FLO‐40685‐2 remains valid.

Panel members at the time of adoption
Andrew Nicholas Birch, Josep Casacuberta, Adinda De Schrijver, Mikolaj Antoni Gralak, Philippe Guerche, Huw Jones, Barbara Manachini, Antoine Messéan, Hanspeter Naegeli, Elsa Ebbesen Nielsen, Fabien Nogué, Christophe Robaglia, Nils Rostoks, Jeremy Sweet, Christoph Tebbe, Francesco Visioli and Jean-Michel Wal.
Panel on Genetically Modified Organisms
gmo_secretariat_applications [at] efsa.europa.eu
EFSA Journal 2018;16(7):5396
Question Number
On request from
European Commission