Brussels, 28 Oct 2004
Opinion adopted by the EFSA GMO Panel on 24 September 2004
Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the notification (Reference C/NL/00/10) for the placing on the market of insect-tolerant genetically modified maize 1507, for import and processing, under Part C of Directive 2001/18/EC from Pioneer Hi-Bred International/Mycogen Seeds*. (Question No EFSA-Q-2004-011)
Summary of the Opinion
This document provides an opinion of the Scientific Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) on 1507 maize, genetically modified to provide protection against specific lepidopteran pests. The maize also contains a gene providing tolerance to the herbicide glufosinate. The opinion is based on a question raised by the Commission related to an application for the placing on the market of 1507 maize under the environmental release Directive 2001/18/EC . The GMO Panel was asked to consider whether there is any scientific reason to believe that the placing on the market of 1507 maize, for import and processing, is likely to cause any adverse effects on human health and the environment (Notification C/NL/00/10). The question followed a scientific assessment which was initially made by the competent authorities of The Netherlands and subsequently evaluated by all other Member States. An assessment of the 1507 maize was requested by the Commission because of questions 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.
In delivering its opinion the Panel considered the application, additional information provided by the applicant and the specific questions and concerns raised by the Member States. Further information from other applications for the placing on the market of 1507 maize under current regulatory procedures, i.e. notification C/ES/01/01 with the extended scope for cultivation and an application under the novel foods Regulation (EC) 258/97 which was transformed into application EFSA-GMO-NL-2004-02 for the authorisation of food products under Regulation (EC) No 1829/2003 on GM food and feed, were taken into account where appropriate. For formal reasons the assessment of the latter applications will result in separate opinions.
The 1507 maize was assessed with reference to its intended use and the appropriate 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 (EFSA, 2004). The scientific assessment included examination of the DNA inserted into 1507 using particle bombardment and the nature and safety of the target proteins produced by the transgenic event with respect to toxicology and allergenicity. Furthermore, a comparative analysis of agronomic traits and composition was undertaken and the safety of the whole feed was evaluated. A nutritional and an environmental assessment, including monitoring plan, were both undertaken.
1507 maize has been developed for protection against specific lepidopteran pests such as the European corn borer (Ostrinia nubilalis) and Sesamia spp. and for tolerance to the herbicide glufosinate. The insect resistance was provided by expression of a truncated CRY1F protein from Bacillus thuringiensis ssp. aizawai and tolerance to the herbicide was conferred by a phosphinothricin-N-acetyltransferase (PAT) from Streptomyces viridochromogenes. Maize embryos were transformed by particle bombardment to transfer a restriction fragment containing these two genes. As a result of the genetic modification, the 1507 event contains an insert bearing both cry1F and pat genes, under the control of the maize ubiquitin and the 35S promoters, respectively.
Molecular analysis showed that 1507 maize contains one copy of the DNA fragment used for transformation and that this is present in a single insertion locus in the nuclear genome of the GM plant. The complete DNA sequence of the insert is provided. In addition to the intact genes, the insert in 1507 maize includes DNA sequences originating from the fragment used for transformation as well as maize chloroplast and nuclear genome sequences at both ends of the inserted sequence. Whilst these sequences may have resulted from the transformation process (insertional events) there were no indications that these additional fragments would result in the transcription of new RNA other than the mRNAs transcribed from the cry1F and pat genes. In the unlikely event that this does occur, bioinformatics analysis showed that any resulting peptides or proteins would have no homology to known toxins or allergens. Analysis of DNA sequences flanking both ends of the insert shows that they correspond to maize genomic DNA.
Analysis of kernel chemical composition from field trials in South America and Europe showed that 1507 was substantially equivalent to its non-GM comparator. Furthermore, appropriate animal feeding trials indicated that 1507 is nutritionally equivalent to its non-GM comparator.
The notification C/NL/00/10 only concerns import and processing. There is therefore no requirement for scientific information on possible environmental effects associated with the cultivation of the maize lines. The GMO Panel agrees that unintended environmental effects due to the establishment and spread of GM 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 considers that the information available for 1507 maize addresses the outstanding questions raised by the Member States and considers that 1507 maize will not have an adverse effect on human and animal health or the environment in the context of its proposed use.
The GMO panel is of the opinion that a strict separation of the GMO seeds between food and feed chain uses is extremely unlikely. For this reason no single authorisation should be considered unless aspects of both food and feed safety are authorised.