Source: European Food Safety Authority (EFSA)

Opinion of the GMO Panel related to the notification (Reference C/SE/96/3501) for the placing on the market of genetically modified potato EH92-527-1 with altered starch composition, for cultivation and production of starch, under Part C of Directive 2001/18/EC from BASF Plant Science [1]

Opinion in PDF format:
http://www.efsa.eu.int/science/gmo/gmo_opinions/1373/gmo_op_ej323_potatoeh92-527-1_en1.pdf

Summary in PDF format:
http://www.efsa.eu.int/science/gmo/gmo_opinions/1373/gmo_op_ej323_potatoeh92-527-1_summary_en1.pdf

Summary

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 cultivated within a closed loop system that is on a contractual basis.

The opinion is based on a question raised by the Commission relating to a notification for the placing on the market of the potato EH92-527-1 under Directive 2001/18/EC (Reference C/SE/96/3501). The question followed a scientific assessment which was made initially by the Competent Authority of Sweden and evaluated subsequently by all other Member States. An assessment of the potato EH92-527-1 was requested by the Commission because of issues raised by several Member States following the evaluations at the national level. When this is the case, EU legislation requires that EFSA carries out a further assessment and provides an opinion. The GMO Panel was therefore requested to provide a scientific opinion as to whether there is any scientific reason to believe that placing on the market of the GM potato (EH92-527-1) for cultivation and production of starch is likely to cause any adverse effects on human health and the environment.

In delivering its opinion the GMO Panel considered the notification, additional information provided by the applicant and the specific questions and concerns raised by the Member States. Further information from another application for the placing on the market of the potato EH92-527-1 for food and feed uses, i.e. application EFSA-GMO-UK-2005-14 under Regulation (EC) No 1829/2003, was taken into account where appropriate, as were comments from 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. The data indicate that after starch extraction, the by-products of the GM potato are as safe as those from the non-GM parental line.

Notification C/SE/96/3501 concerns cultivation of potato EH92-527-1 for the production of starch. Potato rarely survives outside the cultivated environment and there is no indication of enhanced weediness or invasiveness of potato EH92-527-1. Potato has no cross-compatible wild relatives in Europe. Since it is vegetatively propagated and the natural exchange of genetic material is only possible with other varieties of potato, there is negligible risk to the environment of any transgene flow. Therefore, no unintended environmental effects due to the establishment and spread are anticipated. In the unlikely event that horizontal transfer of gene sequences would occur between the GM potato and bacteria, the bacteria would not pose any additional risk to human health or the environment. No adverse effects on plant-associated organisms and soil function have been observed or would be likely from cultivation of the potato EH92-527-1. In addition, the GMO Panel agrees with the approach proposed by the applicant in the environmental monitoring plan.

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 health or the environment in the context of its proposed uses.

[1] For citation purposes: Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the notification (Reference C/SE/96/3501) for the placing on the market of genetically modified potato EH92-527-1 with altered starch composition, for cultivation and production of starch, under Part C of Directive 2001/18/EC from BASF Plant Science, The EFSA Journal (2006) 323, 1-20.