Following the submission of application EFSA-GMO-RX-001 under Regulation (EC) No 1829/20031 from Pioneer Overseas Corporation and Dow Agrosciences LLC, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific opinion on the data submitted in the frame of a renewal of authorisation application of the insect-resistant and herbicide-tolerant genetically modified (GM) maize 1507. The scope of renewal application EFSA-GMO-RX-001 is for food and feed uses, import and processing, but excludes cultivation within the European Union (EU).
At the time of submission of the renewal application EFSA-GMO-RX-001, no EFSA Guidance document was in place to assist the applicant in the preparation and presentation of their renewal application. Therefore, the applicant submitted data in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003. At the time EFSA validated renewal application EFSA-GMO-RX-001, the ‘Guidance for renewal applications of genetically modified food and feed authorised under Regulation (EC) No 1829/2003’ (EFSA GMO Panel, 2015) was published and the GMO Panel requested the applicant to update the data package to be in line with these guidelines.
In delivering its scientific opinion, the GMO Panel took into account application EFSA-GMO-RX-001, additional information provided by the applicant, scientific comments submitted by the Member States and relevant scientific publications. The data package received in the frame of the renewal application EFSA-GMO-RX-001 contained: post-market environmental monitoring reports, systematic search and evaluation of literature, updated bioinformatics analyses and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed this data package for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the frame of the original application.
In conclusion, under the assumption that the DNA sequence of the event in maize 1507 considered for renewal is identical to the corrected sequence of the originally assessed event, the GMO Panel concludes that no new hazards or modified exposure and no new scientific uncertainties were identified for the application for renewal that would change the conclusions of the original risk assessment on maize 1507 (EFSA, 2005b, 2009).