Scientific Opinion on an application by Syngenta (EFSA‐GMO‐DE‐2011‐99) for the placing on the market of maize Bt11 × 59122 × MIR604 × 1507 × GA21 and twenty subcombinations, which have not been authorised previously independently of their origin, for food and feed uses, import and processing under Regulation (EC) No 1829/2003

Abstract

In this opinion, the EFSA GMO Panel assesses the five-event stack maize and 20 of its subcombinations independently of their origin. The EFSA GMO Panel has previously assessed the five single events that are combined to produce this five-event stack maize Bt11 9 59122 9 MIR604 9 1507 9 GA21 and did not identify safety concerns. No new data on the single events, leading to a modification of the original conclusions on their safety, were identified. The molecular, agronomic, phenotypic and compositional data on the five-event stack maize did not give rise to safety concerns and there is no reason to expect interactions between the single events impacting on the food and feed safety of the five-event stack maize. Considering the scope of the application (no cultivation), routes of exposure and limited exposure levels, the Panel concludes that this five-event stack maize would not raise safety concerns in the event of accidental release of viable grains into the environment. The EFSA GMO Panel concludes that the fiveevent stack maize is as safe and as nutritious as its conventional counterpart in the context of its scope. For the 20 subcombinations, the EFSA GMO Panel followed a weight-of-evidence approach, and concluded that they are expected to be as safe as the five-event stack maize. No specific data were submitted for the subcombinations included in the scope of this application that could be produced by conventional crossing through targeted breeding approaches. In order to reduce the consequent uncertainties and to confirm assumptions made for their assessment, the EFSA GMO Panel considers that the applicant should provide relevant information, if these subcombinations were to be created via targeted breeding approaches and imported into the EU in the future. In this case, this information should focus on expression levels of the newly expressed proteins. A minority opinion expressed by an EFSA GMO Panel member is appended to this opinion.

Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐DE‐2011‐95) for the placing on the market of genetically modified maize 5307 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Syngenta Crop Protection AG taking into consideration an additional toxicological study

“…Taking into account the previous assessment and the new information, the GMO Panel concludes that maize 5307, as assessed in the scientific opinion on application EFSA- GMO-DE-2011-95 (EFSA GMO Panel, 2015 and in the supplementary toxicity study, is as safe and nutritious as its conventional counterpart in the scope of the application. Background and Terms of Reference as provided by the requestor On 16 April 2015, the GMO Panel adopted a scientific opinion on application EFSA-GMO-DE-2011-95 for the placing on the market of maize 5307 for food and feed uses, import and processing under Regulation (EC) No 1829/2003(EFSA GMO Panel, 2015. In this scientific opinion, the GMO Panel considered that the information available for maize 5307 was not sufficient to reach a final overall conclusion since 'the EFSA GMO Panel cannot conclude on the safety of the eCry3.1Ab protein'.…”

Risk assessment of new sequencing information on GM maize event DAS‐59122‐7

“…Based on the data provided, it can be concluded that the sequence differences found in maize event DAS-59122-7 in 2016 were already present in the original material used in the risk assessment process (EFSA, 2007(EFSA, , 2008(EFSA, , 2009aEFSA GMO Panel, 2010a, 2013, 2016. Furthermore, the differences identified are located outside the coding sequences of the newly expressed proteins Cry34Ab1, Cry35Ab1 and PAT; two nucleotides are in the TA peroxidase promoter of the cry35Ab1 expression cassette and one nucleotide is in the 5 0 genomic flanking region.…”