EFSA gave positive opinion for five‐event stack maize from Monsanto

Following the submission of application EFSA‐GMO‐NL‐2016‐134 under Regulation (EC) No 1829/2003 from Monsanto Company (referred to hereafter as the applicant), the Panel on Genetically Modified Organisms of the European Food Safety Authority (referred to hereafter as GMO Panel) was asked to deliver a Scientific Opinion on the safety of genetically modified drought‐ and glyphosate‐tolerant and insect resistant maize MON 87427 × MON 87460 × MON 89034 × MIR162 × NK603 (referred to hereafter as ‘five‐event stack maize’) and its subcombinations independently of their origin, according to the Commission Regulation (EU) No 503/2013 (referred to hereafter as ‘subcombinations’). The scope of application EFSA–GMO–NL–2016–134 is for the placing on the market of maize MON 87427 ×MON 87460 × MON 89034 × MIR162 × NK603 and all its subcombinations independently of their origin for food and feed uses, import and processing.

Maize MON 87427 ×MON 87460 × MON 89034 × MIR162 × NK603 (five‐event stack maize) was produced by conventional crossing to combine five single events: MON 87427, MON 87460, MON 89034, MIR162 and NK603. The GMO Panel previously assessed the five single maize events and eleven of the subcombinations and did not identify safety concerns. 

No new data on the single maize events or the 11 subcombinations that could lead to modification of the original conclusions on their safety were identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the five‐event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that the five‐event stack maize, as described in this application, is as safe as and nutritionally equivalent to its non‐GM comparator and the non‐GM reference varieties tested.

In the case of accidental release of viable grains of the five‐event stack maize into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in the 14 maize subcombinations not previously assessed and concludes that these are expected to be as safe as and nutritionally equivalent to the single events, the previously assessed subcombinations and the five‐event stack maize. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of the five‐event stack maize. Post‐market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the five‐event stack maize and its subcombinations are as safe as its non‐GM comparator and the tested non‐GM reference varieties with respect to potential effects on human and animal health and the environment.