This document provides an opinion of the Scientific Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) on genetically modified potato EH92-527-1 (Unique identifier BPS-25271-9), with an altered starch composition (higher amylopectin:amylose ratio). Amylopectin starch potatoes are mainly used for the production of starch for industrial purposes. The GM potato tubers are not intended for direct human consumption. The potatoes will be marketed within a closed loop (identity preservation) system.
In delivering its opinion the GMO Panel considered the application (ref. EFSA-GMO-UK-2005-14) under Regulation (EC) 1829/2003, additional information provided by the applicant and the specific comments submitted by the Member States. Further information from another application, i.e. application C/SE/96/3501 under Directive 2001/18/EC, for placing the potato EH92-527-1 on the market under current regulatory procedure were taken into account where appropriate, as were issues raised by the Member States. Although an overall single risk assessment for all uses of potato EH92-527-1 has been made, for regulatory reasons, opinions for the application under Regulation (EC) No 1829/2003 and the notification under Directive 2001/18/EC are issued separately.
The potato EH92-527-1 was assessed with reference to its intended uses employing the appropriate principles as 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 examination of the DNA inserted into potato EH92-527-1, the nature and safety of the modification in protein expression in the plants with respect to toxicology and allergenicity. Furthermore, a comparative analysis of agronomic traits and composition as well as the safety of the food/feed was evaluated. Both nutritional and environmental risk assessments, including monitoring plan, were undertaken.
The potato EH92-527-1 is derived from the cultivar Prevalent. Potato leaf discs were transformed by Agrobacterium-mediated gene transfer technology. The modification involves inhibition of the expression of granule bound starch synthase protein (GBSS) responsible for amylose biosynthesis. As a result, the starch produced has little or no amylose and consists of amylopectin (branched starch), which modifies the physical properties of the starch. A gene conferring kanamycin resistance (nptII) was used as a selectable marker.
Molecular analysis shows that potato EH92-527-1 contains two partial copies of the DNA fragment, i.e. the insert, including the flanking region, was duplicated in reverse orientation and joined tail-to-tail. This is present at a single locus in the nuclear genome of the GM plant. The complete DNA sequence of the insert was provided. The GMO Panel is of the opinion that bioinformatic analysis of the DNA insert and flanking regions indicates no cause for concern, and that sufficient evidence for the stability of the insert structure was provided.
The potato EH92-527-1 has been developed for amylopectin production. The amylopectin will mainly be used in technical non-food products such as paper. Compositional analysis shows that the potato EH92-527-1 falls within expected patterns of variation for potato, except for the change in starch composition due to the genetic modification. By-products of the starch extraction process (e.g. pulp) are used for other purposes including animal feed. The risk assessment includes an analysis of data from appropriate animal feeding trials. These data indicate that after starch extraction, the by-products of the GM potato are as safe as those from the non-GM parental line.
The intended use of potato EH92-527-1 is in the starch production industry with the pulp used for animal feed. However the applicant has concluded that it cannot be excluded that the GM potato and some products of the starch processing may be used as, or be present in food. The application EFSA-GMO-UK-2005-14 includes a scientific risk assessment of potato EH92-527-1 and by-products of the starch processing for food and feed uses. The GMO Panel was requested to conduct a scientific assessment of the potato EH92-527-1 and derived products for food and feed uses.
The EH92-527-1 potato tubers are not intended for human or animal consumption as a whole. Potential impact of the cultivation of the potato EH92-527-1 on the environment was addressed in the assessment of notification C/SE/96/3501 under Directive 2001/18/EC.
In conclusion, the GMO Panel considers that the information available for the potato EH92-527-1 addresses the outstanding questions raised by the Member States and considers that the potato EH92-527-1 is unlikely to have an adverse effect on human and animal health or the environment in the context of its proposed uses.