This document provides an opinion of the Scientific Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) on products produced from genetically modified sugar beet H7-1 (Unique Identifier KM-ØØØH71-4), developed to provide tolerance to glyphosate-containing herbicides. The scope of this application is for food produced from or containing ingredients produced from sugar beet H7-1 and feed produced from sugar beet H7-1. These products are for example sugar, syrup, dried pulp and molasses.
In delivering its opinion the GMO Panel considered the application (Reference EFSA-GMO-UK-2004-08), additional information provided by the applicant (KWS SAAT AG and Monsanto Company) and scientific comments submitted by the Member States.
The sugar beet H7-1 was assessed with reference to its intended use and the risk assessment principles described in the Guidance document of the Scientific Panel on Genetically Modified Organisms for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed. The scientific assessment included a molecular characterisation of the inserted DNA present in sugar beet H7-1 and of the insertion site. The nature and safety of the newly expressed protein in the genetically modified plants was assessed with respect to toxicology and allergenicity. Furthermore, a comparative analysis of agronomic traits and composition was undertaken and the safety of the whole food/feed was evaluated.
The sugar beet H7-1 was developed for glyphosate tolerance by Agrobacterium tumefaciens-mediated introduction of the gene cp4 epsps, isolated from the soil bacterium Agrobacterium sp. CP4, into the sugar beet. The inserted gene encodes a 5 enolpyruvylshikimate 3 phosphate synthase protein (CP4 EPSPS) that, in contrast to the plant’s own EPSPS protein, is insensitive to glyphosate-containing herbicides and, therefore, can continue synthesizing aromatic amino acids also in the presence of these herbicides.
Molecular characterisation of the DNA insert showed that sugar beet H7-1 contains one copy of the expected insert and that this is present at a single locus in the nuclear genome of the genetically modified plant. The DNA sequence of the insert and the flanking sequences were provided. The four mismatches observed in the insert sequence have no influence on the CP4 EPSPS protein. Bioinformatic analysis showed that potential fusion proteins would have no homology to known toxins or allergens.
Sugar beet H7-1 was found to contain the CP4 EPSPS protein associated with the new trait of glyphosate tolerance. Besides this deliberate change, this sugar beet showed no marked alterations in composition, agronomy and phenotype compared with the control lines and reference lines. The GMO Panel therefore concludes that sugar beet H7-1 is compositionally and phenotypically equivalent to non genetically modified sugar beet, except for the trait that has been introduced.
A 90 day sub chronic rodent study with processed pulp from sugar beet H7-1 indicated that there are no adverse effects from the consumption of products produced from sugar beet H7-1.
A feeding study conducted on sheep with sugar beet H7-1 showed no adverse effects. The GMO Panel considers that the nutritional properties of products produced from this GM sugar beet would be no different from those of conventional sugar beet. The GMO Panel has, therefore, not identified any issue requiring post-market monitoring of sugar beet.
Since the scope only covers food produced from or containing ingredients produced from sugar beet H7-1 and feed produced from sugar beet H7-1, an environmental monitoring plan is not required.
In conclusion, the GMO Panel considers that the information available for sugar beet H7-1 addresses the outstanding questions raised by the Member States and considers that products produced from sugar beet H7-1 are unlikely to have any adverse effect on human and animal health or the environment in the context of its intended uses.