Risk assessment of new sequencing information for genetically modified sugar beet H7-1

EFSA J. 2022 Jun 8;20(6):e07354. doi: 10.2903/j.efsa.2022.7354. eCollection 2022 Jun.

Abstract

The EFSA Panel on genetically modified organisms (GMO Panel) has previously assessed genetically modified (GM) sugar beet H7-1. This sugar beet was found to be as safe and nutritious as its conventional counterpart and commercial sugar beet varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 19 February 2021, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM sugar beet H7-1 and to indicate whether the previous conclusions of the GMO Panel on safety of GM sugar beet H7-1 remain valid. The new sequencing data indicated seven nucleotide differences as compared to the sequence originally provided in applications EFSA-GMO-UK-2004-08 and EFSA-GMO-RX-006: five nucleotides in the 5' genomic flanking region and two nucleotides in the T-DNA region of the insert. Two mismatches between the originally submitted H7-1 event sequence and the plasmid sequence were confirmed by the newly obtained H7-1 sequence. Based on the analysis of the provided data, EFSA considers that the newly reported sequence differences are most likely attributed to sequencing errors in the originally reported sugar beet H7-1 event sequence. The new sequencing data and the bioinformatic analyses performed on the new sequence did not give rise to safety issues. Therefore, EFSA concludes that the original risk assessment of sugar beet H7-1 remains valid.

Keywords: GMO; Regulation (EC) No 1829/2003; nucleotide sequence; sugar beet, H7-1.