EFSA issues opinions on new GM maize: NK 603 maize considered as safe as conventional maize

"These opinions have been requested as the first of a series of risk assessments of different GM plant varieties,” said Dr. Harry Kuiper, Chair of the Scientific Panel on Genetically Modified Organisms (GMO). “Our Scientific Panel was recently asked to review the evidence presented on GM maize NK 603 in order to evaluate its safety.

A comprehensive environmental assessment was not conducted as the applications for GM maize NK 603 concern only import and processing, but not cultivation of the maize. The risk assessment process included examination of: the DNA integrated into NK 603; 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, allergenicity and nutritional value of NK 603 in comparison with conventional maize.“ Having considered all of the evidence provided, the Panel concluded that NK 603 maize is as safe as conventional maize and therefore the placing on the market of NK 603 maize – for import for processing and food or feed use—is unlikely to have an adverse effect on human or animal health, or in this context, on the environment. Following EFSA’s scientific risk assessment, the Commission will draft proposals concerning the possible authorisation of NK 603 maize for consultation of the Member States in a Regulatory Committee.


These opinions relate to the risk assessment of a new GM maize (NK603 “Roundup Ready” maize) and of food and feed products derived from it. This maize type has been genetically modified to provide tolerance to the herbicide glyphosate (commonly formulated as “Roundup”). The stated purpose of this modification is to allow farmers to manage weeds more effectively in maize fields during cultivation.

The risk assessment is based on two questions raised by the Commission related to applications for the placing of the maize on the market by Monsanto under Regulation (EC) No 258/97 on novel food and under Directive 2001/18/EC on the deliberate release of genetically modified organisms into the environment.

In the first question, the EFSA Panel on Genetically Modified Organisms was asked to assess the safety of foods and food ingredients derived from NK 603 maize, and in the second question, it was requested to determine whether there is any scientific reason to believe that the placing on the market of NK 603 maize, for import and processing, is likely to cause any adverse effects on human health, or in this context, on the environment. These questions followed two separate scientific assessments which were initially carried out in the Netherlandsand Spainand subsequently evaluated by all other Member States. The EFSA assessment was requested by the Commission because of additional questions raised as a result of these MemberStateevaluations. EU legislation requires that, in such cases, EFSA should carry out a further assessment and provide an opinion.

In delivering these opinions 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 has been provided for both opinions.

NK603 maize has been developed for resistance to “Roundup” herbicide by introducing a glyphosate tolerant gene. The risk assessment process was conducted using the 2003 EU scientific guidance for the risk assessment of genetically modified plants and derived food and feed1.