European Food Safety Authority (EFSA)

Opinion of the Scientific Panel on genetically modified organisms [GMO] on a request from the Commission related to the Notification (Reference CE/ES/00/01) for the placing on the market of herbicide-tolerant genetically modified maize NK603, for import and processing, under Part C of Directive 2001/18/EC from Monsanto1."

Question number: EFSA-Q-2003-003

Summary  (0.1Mb)

Opinion  (0.2Mb)

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 maize NK603 and derived food and feed products. The opinion is based on two questions raised by the Commission related to applications for the placing of the maize on the market by Monsanto under the Novel Food Regulation (EC) No 258/97 and the Directive 2001/18/EC on the deliberate release of genetically modified organisms (GMOs) into the environment.

In the first question, the GMO Panel was asked to consider the safety of foods and food ingredients derived from NK 603 maize and in the second question it was requested to consider whether there is any scientific reason to believe that the placing on the market of NK603 maize, for import and processing, is likely to cause any adverse effects on human health and the environment. The questions followed two separate scientific assessments which were initially made by the appropriate authorities in The Netherlands and Spain and subsequently evaluated by all other Member States. An assessment of the NK603 maize was requested by the Commission because of questions raised by several Member States following the evaluations at national level. When this is the case, EU legislation requires that EFSA carries out a further assessment and provides an opinion.

In delivering its opinion the Panel considered the applications and additional information provided by the applicant and the specific questions and concerns raised by the Member States. At the request of the Commission, the Panel has provided two separate opinions. However, as both dossiers cover to a large extent the same issues a single risk assessment is provided for both opinions.

The risk assessment process was conducted using scientific guidance published by the EC Scientific Committees. It included examination of the DNA integrated into NK603 using particle bombardment, the nature and safety of the target proteins produced by the transgenic event and the possibility that the genetic modification may have influenced the safety (including allergenicity) and the nutritional value of NK603 in comparison with conventional maize.

The NK603 maize has been genetically modified to provide tolerance to the herbicide glyphosate. The stated purpose of the modification is to allow farmers to manage weeds more effectively in maize fields during cultivation. NK603 maize has been planted for field studies within the EU and has been marketed in several countries outside the EU. The present applications concern only import and processing, but not cultivation of the maize. If approved it would therefore make it possible to place on the market NK603 maize and derived products, such as starch, oil, maize gluten feed and maize meal for food and feed use, whereas the crop would be grown and harvested outside the EU.

Glyphosate tolerance was achieved by the introduction of a gene encoding glyphosate tolerant 5-enoylpyruvylshikimate-3-phosphate synthase from Agrobacterium sp. strain CP4 (CP4 EPSPS). The EPSPS activity is needed for the biosynthesis of aromatic amino acids in plants and in micro-organisms but the structure of the plant enzyme makes it commonly vulnerable to glyphosate, thereby causing the plants to be killed by the herbicide.

Molecular analysis showed that NK603 contains a single inserted copy of the DNA present in the construct used for the transformation. The plasmid vector contains two adjacent plant gene expression cassettes each containing a single copy of the cp4 epsps gene. The insert in NK603 does include some molecular re-arrangements at one end of the insert and also includes a fragment of chloroplast DNA. These re-arrangements and the insertion of chloroplast DNA do not lead to new traits and are not considered to pose a safety risk. In the unlikely event that a new peptide or protein is produced as a consequence of the insertion event, bioinformatics analysis showed that these would have no homology to known toxins or allergens.

As a result of the genetic modification NK603 contains two slightly different CP4 EPSPS proteins expressed from two copies of the cp4 epsps gene using different promoters. The proteins differ from each other in one amino acid. Analysis of the impact of this change indicated no apparent changes in EPSPS protein structure, activity, toxicity or allergenicity using appropriate bioinformatics approaches, in vitro digestion procedures and studies on experimental animals. Furthermore, appropriate animal feeding trials indicated that NK603 was as safe as its non-GM comparator. Analysis of the grain from field trials in the USA and Europe showed that NK603 had the same composition as its non-GM comparator.

The notification C/ES/00/01 for maize NK603 only concerns import. There is therefore no requirement for scientific information on possible environmental effects associated with the cultivation of maize NK603. The GMO Panel agrees with the conclusions of the environmental risk assessment by the applicant that the likelihood of unintended environmental effects due to the adventitious release and spread of NK603 maize will not be different from that of traditionally bred maize. The monitoring plan provided by the applicant is in line with the intended uses for the GMO.

In conclusion, the Panel has considered all the evidence provided and is of the opinion that NK603 maize is as safe as conventional maize and therefore the placing on the market of NK603 maize for food or feed or processing is unlikely to have an adverse effect on human or animal health or, in that context, on the environment.