MIR162 SYN-IR162-4
Mais MIR162; Handelsname: Agrisure™ Viptera
Insektenresistenz
Eingeführte Gene:
vip3Aa20 codierend für insektizides Protein (vip3aa-Variante)
pmi* codierend für Phosphomannose-Isomerase (PMI)
Antragsteller: Syngenta Crop Protection NV/SA
Antragsstellung: 12. Februar 2021
EFSA-Sicherheitsbewertung: 26.02.2021 - 22.09.2022
Zulassung: 16.10.2023
Erstzulassung: 18.10-2012
► EFSA-Stellungnahme: GMO Panel (2022): Scientific Opinion on the assessment of genetically modified maize MIR162 for renewal
authorisation under Regulation (EC)No 1829/2003 (application EFSA-GMO-RX-025). EFSA Journal 20 (9): 7562, 13 pp | https://doi.org/10.2903/j.efsa.2022.7562 (EFSA-Q-2021-00122)
The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. The GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-025 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MIR162
► 15.04.2023: Statement on the risk assessment of additional information on maize MIR162. EFSA Journal 21( 4): 7935, 8 pp. | https://doi.org/10.2903/j.efsa.2023.7935
The new information is included in a European patent that reportsa decrease in male fertility in some MIR162 inbred lines, pointing to a potential link between suchdecrease and the Vip3 protein expressed by maize MIR162. The EFSA GMO Panel evaluated the dataprovided by the patent owner and found scarce support for a causal link between Vip3 and decreasedfertility. The general hypothesis of an association between event MIR162 and altered fertility could notbe confirmed. The EFSA GMO Panel conducted the safety assessment based on the conservativeassumption that such an association exists. The EFSA GMO Panel concluded that a decrease in malefertility would have no impact on the previous conclusions on maize MIR162 and stacked eventscontaining MIR162
► EFSA-Stellungnahme: EFSA Panel on Genetically Modified Organisms (GMO);Scientific Opinion on application (EFSA-GMO- DE-2010-82) for the placing on the market of insect resistant genetically modified maize MIR162 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta. EFSA Journal 2012;10(6):[27 pp.]. doi:10.2903/j.efsa.2012.2756.
"The Panel concluded that maize MIR162 is as safe as its conventional counterpart and that theoverall allergenicity of the whole plant is not changed. A feeding study with broiler chickens confirmed that grain produced by maize MIR162 is as nutritious as that produced by its conventional counterpart and a non-GM commercial variety. In conclusion, the EFSA GMO Panel is of the opinion that maize MIR162 is as safe and as nutritious as its conventional counterpart and a non-GM commercial variety, 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."
"In conclusion, the EFSA GMO Panel considers that the information available for maize MIR162 addresses the scientific comments raised by the Member States and that maize MIR162, as described in this application, is as safe as its conventional counterpart and non-GM commercial varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. "
► Kommissionsentscheidung: DURCHFÜHRUNGSBESCHLUSS (EU) 2023/2143 DER KOMMISSION vom 13. Oktober 2023 zur
Artikel 2-Erneuerung der Zulassung: Die Zulassung für das Inverkehrbringen folgender Erzeugnisse wird erneuert:
a) Lebensmittel und Lebensmittelzutaten, die genetisch veränderten Mais SYN-IR162-4 enthalten, aus ihm bestehen oder aus
ihm gewonnen werden;
b) Futtermittel, die genetisch veränderten Mais SYN-IR162-4 enthalten, aus ihm bestehen oder aus ihm gewonnen werden;
c) Erzeugnisse, die genetisch veränderten Mais SYN-IR162-4 enthalten oder aus ihm bestehen, für alle anderen als die unter
den Buchstaben a und b genannten Verwendungen, außer zum Anbau.
Zulassungszeitraum: 16.10.2023 – 16.10.2033
Bestehende Zulassungen (Stand Oktober 2017)
