MON 89034 x 1507 x NK 603        MON-89Ø34-3 x DAS-Ø15Ø7-1 x MON-ØØ6Ø3-6

MON 89034 × 1507 × NK603    (alt)

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Antragsteller:               Dow AgroScience und Monsanto Europe S.A.
Antragstellung:            29.01.2009
Sicherheitsbewertung:  27.09.2010;  10.11.2011 einschließlich aller Untergruppen
Zulassungsverfahren:   Im Komitologieverfahren gaben die Gremien keine Stellungnahme ab. Die Kommission muss auf Grundlage  der EFSA-

Stellungnahme eine Entscheidung treffen

Zulassung:                  06.11.2013

► EFSA-Stellungnahme: EFSA Panel on Genetically Modified Organisms (GMO); Scientific Opinion on application (EFSA-GMO-

NL-2009-65) for the placing on the market of insect resistant and herbicide tolerant genetically modified maize MON 89034 × 1507 × NK603 and all sub-combinations of the individual events as present in its segregating progeny, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Dow AgroSciences and Monsanto. EFSA Journal 2010; 8(9):1782. [34 pp.]. doi:10.2903/j.efsa.2010.1782.

„The EFSA GMO Panel is of the opinion that the molecular characterisation data provided for maize MON 89034 × 1507 × NK603 are sufficient. The results of the bioinformatic analyses of the inserted DNA and the flanking regions of the single events MON 89034, 1507 and NK603 do not raise safety concern. The levels of Cry1A.105, Cry2Ab2, Cry1F, PAT and CP4 EPSPS proteins in maize MON 89034 × 1507 × NK603 have been sufficiently analysed and the stability of the genetic modification has been demonstrated. The EFSA GMO panel considers that the molecular characterisation does not indicate a safety concern.“

“The EFSA GMO Panel considers that maize MON 89034 × 1507 × NK603 is as safe and as nutritious as its conventional counterpart and commercial maize varieties and that the overall allergenicity of the whole plant is not changed. In conclusion, the EFSA GMO Panel is of the opinion that maize MON 89034 × 1507 × NK603 and all sub-combinations of the individual events as present in its segregating progeny are as safe and as nutritious as the conventional counterpart and commercial maize varieties, and concludes that this maize and derived products are unlikely to have adverse effects on human and animal health, in the context of its intended uses.”

“The EFSA GMO Panel recommends that appropriate management systems should be in place to restrict seeds of maize MON 89034 × 1507 × NK603 entering cultivation as the latter requires specific approval under Directive 2001/18/EC or Regulation (EC) No 1829/2003. In conclusion, the EFSA GMO Panel considers that the information available for maize MON 89034 × 1507 × NK603 addresses the scientific comments raised by the Member States and concludes that the maize MON 89034 × 1507 × NK603, assessed in this application, is as safe as its conventional counterpart and other appropriate comparators with respect to potential effects on human and animal health and the environment. In addition, the EFSA GMO Panel is of the opinion that crossing of single maize events MON 89034, 1507 and NK603 to produce maize MON 89034 × 1507 × NK603 does not result in interactions between the events which would affect the safety of maize MON 89034 × 1507 × NK603 with respect to potential effects on human and animal health and on the environment, in the context of its intended uses. Based on data provided for maize stack MON 89034 × 1507 × NK603, the single maize events (MON 89034, 1507 and NK603), and for the two double stacks 1507 × NK603 and MON 89034 × NK603, the EFSA GMO Panel is of the opinion that there is no biological reason to expect that any of the other sub-combinations of the individual events as present in its segregating progeny would raise a safety concern. The EFSA GMO Panel concludes that maize MON 89034 × 1507 × NK603 is unlikely to have adverse effects on human and animal health and the environment, in the context of its intended uses.”

EFSA Panel on Genetically Modified Organisms; Statement complementing the EFSA GMO Panel scientific opinion on maize MON 89034

 x 1507 x NK603 (application EFSA-GMO-NL-2009-65), to cover all sub-combinations independently of their origin. EFSA Journal 2011;9(9):2377. [8 pp.] doi:10.2903/j.efsa.2011.2377.

"The EFSA GMO Panel considers it unlikely that the sub-combinations have an adverse effect on human and animal health and the environment in the context of their intended uses, which cover food and feed uses, import and processing. This conclusion was further supported by the previous assessments of maize 1507 x NK603 and maize MON 89034 x NK603 (EFSA 2006, 2009c). The EFSA GMO Panel concludes that the present statement can complement the scientific opinion on maize MON 89034 x 1507 x NK603 to cover all sub-combinations independently of their origin. "

► Entscheidung der Kommission 2013/648/EU: Durchführungsbeschluss der Kommission vom 6. November 2013 über die Zulassung  des 

Inverkehrbringens von aus der genetisch veränderten Maissorte MON89034 × 1507 × NK603 (MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6) bestehenden, diese enthaltenden oder aus dieser gewonnenen Erzeugnissen gemäß der Verordnung (EG) Nr. 1829/2003 des Europäischen Parlaments und des Rates. ABl. L. 302, 38-41 vom 13.11.2013

Die Zulassung gilt für

a) Lebensmittel und Lebensmittelzutaten, die Mais der Sorte MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6 enthalten, aus ihm bestehen oder aus

    ihm gewonnen werden;

b) Futtermittel, die Mais der Sorte MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6 enthalten, aus ihm bestehen oder aus ihm
    gewonnen werden;

c) Mais der Sorte MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON- ØØ6Ø3-6 in Erzeugnissen, die ihn enthalten oder aus ihm bestehen,
    für alle anderen als die unter den Buchstaben a und b genannten Verwendungen, außer zum Anbau .

Zulassungszeitraum: 06.11.2013 – 05.11.2023