Following a request from the European Commission, the Scientific Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on an application submitted by Monsanto under Regulation (EC) No 1829/2003 (reference EFSA-GMO-RX-MON863[8.1.b/20.1.b]) for renewal of the authorisation of existing feed materials, feed additives and food additives produced from genetically modified maize MON863.
The scope of this application covers the continued marketing of existing feed materials, feed additives and food additives produced from maize MON863 which were lawfully placed on the market in the Community before the date of entry into force of Regulation (EC) No 1829/2003. After the date of entry into force of Regulation (EC) 1829/2003 these products were notified to the European Commission according to Articles 8(1)(b) and 20(1)(b) of this Regulation and subsequently included in the Community Register of genetically modified food and feed. The scope of this application excludes import of viable plant material and cultivation.
Maize MON863 expresses a variant Bacillus thuringiensis cry3Bb1 gene which confers protection against coleopteran pests, principally the corn rootworm (Diabrotica spp.). In addition, a selectable marker gene nptII encoding neomycin phosphotransferase II has been introduced.
The EFSA GMO Panel has previously issued opinions related to a Notification (reference C/DE/02/09) for the placing on the market of maize MON863 for import and processing under Part C of Directive 2001/18/EC and to a request under Article 4 of the Novel Food Regulation (EC) No 258/97 for the placing on the market of foods and food ingredients derived from maize MON863. In these opinions the Panel concluded that MON863 will not have an adverse effect on human and animal health or the environment in the context of its intended use. In addition, several applications related to stacked events including maize MON863 have been evaluated and the GMO Panel concluded that these stacked events are unlikely to have an adverse effect on human and animal health and on the environment, in the context of their intended uses.
In delivering its opinion the EFSA GMO Panel considered the information provided in the renewal application (reference EFSA-GMO-RX-MON863[8.1.b/20.1.b]), additional information submitted by the applicant on request of the EFSA GMO Panel, the scientific comments submitted by Member States as well as relevant information published in the scientific literature. In accordance with the Guidance Document for renewal of authorisations of existing GMO products, the EFSA GMO Panel has taken into account the new information and data which have become available during the authorisation period.
With regard to the molecular data on maize MON863 that have already been evaluated in the context of the previous applications on maize MON863, the EFSA GMO Panel refers to its previous scientific opinions. The scientific assessment included the transformation process, the vectors used and the transgenic constructs in the GM maize MON863. The further assessment presented here is based on the information provided by the applicant in application EFSA-GMO-RX-MON863[8.1.b/20.1.b], including updated bioinformatic analyses.
According to the information provided by the applicant, MON863 and GM maize containing event MON863 stacked with other GM events (which have been approved within the EU) have been cultivated in the USA. Scientific publications, which have become available since the previous opinions of the EFSA GMO Panel on maize MON863, have been assessed by the GMO Panel and did not raise safety issues. In addition, bioinformatic analyses comparing the amino acid sequences of the newly expressed proteins in maize MON863 with amino acid sequences in updated data bases of toxic and allergenic proteins confirmed the results of the previous studies which identified no relevant similarities between the newly expressed proteins Cry3Bb1 and NptII and known allergens or proteins toxic to mammals.
The scope of this application excludes import of viable plant material, which is covered by the previous opinions, and cultivation. Therefore, there is no requirement for scientific information on environmental safety assessment of accidental release or cultivation of maize MON863. A post-market environmental monitoring plan for maize MON863 is not required.
The EFSA GMO Panel has evaluated the new information provided by the applicant and the scientific literature and concluded that there was no new information that would require changes of its previous scientific opinions on maize MON863 (EFSA, 2004a,b). Therefore, the EFSA GMO Panel reiterates its previous conclusions that GM maize MON863 and its products which are the subject of this application are unlikely to have an adverse effect on human and animal health or the environment in the context of its intended uses (EFSA, 2004a,b).