Pursuant to Directive 2001/18/EC, the placing on the market of a product containing or consisting of a genetically modified organism or a combination of genetically modified organisms is subject to written consent being granted by the competent authority of a Member State, in accordance with the procedure laid down in that Directive.

A notification concerning the placing on the market of two genetically modified maize products (Zea mays L., line MON 863 and hybrid MON 863 × MON 810) was submitted by Monsanto SA to the competent authority of Germany.

The notification covers importation and use as for any other maize grains including feed but not food use, with the exception of the cultivation in the Community of varieties derived from the MON 863 transformation event as well as with the exception of the cultivation in the Community of MON 863 × MON 810 hybrids.

In accordance with the procedure provided for in Article 14 of Directive 2001/18/EC, the competent authority of Germany prepared an assessment report, which was submitted to the Commission and the competent authorities of the other Member States. That assessment report concludes that no reasons have emerged on the basis of which consent for the placing on the market of MON 863 maize as well as MON 863 × MON 810 maize should be withheld, if specific conditions are fulfilled.

The competent authorities of other Member States raised objections to the placing on the market of the product.

Concerning the hybrid MON 863 × MON 810, the European Food Safety Authority considered that it is scientifically valid to use the data from the single lines MON 863 and MON 810 to support the safety assessment of the hybrid MON 863 × MON 810, but decided regarding the need for confirmatory data for the safety assessment of the hybrid itself, to request a 90-day sub-chronic rat study with the maize hybrid in order to complete its safety assessment. Thus, only the safety assessment of the maize line MON 863 has been finalised.

An examination of each of the objections in the light of Directive 2001/18/EC, of the information submitted in the notification and of the opinion of the European Food Safety Authority, discloses no reason to believe that the placing on the market of Zea mays L. line MON 863 will adversely affect human or animal health or the environment.

In light of the opinion of the European Food Safety Authority, it is not necessary to establish specific conditions for the intended uses with regard to the handling or packaging of the product and the protection of particular ecosystems, environments or geographical areas.

Prior to the placing on the market of the product, the necessary measures to ensure its labelling and traceability at all stages of its placing on the market, including verification by appropriate validated detection methodology, should be applicable.