Based on the scientific evidence published worldwide and the results of risk assessment trials conducted in Viet Nam, the information and data provided in this dossier demonstrate that genetically modified maize event MIR162 is safe for the environment and biodiversity in Viet Nam. This conclusion is supported by the following findings:

The possibility of gene flow from MIR162 maize exists but is not considered a significant concern because: (1) vertical gene flow from MIR162 maize to wild relatives is highly unlikely, as such species do not occur in Viet Nam; (2) to date, there is no evidence supporting horizontal gene transfer to microorganisms; and (3) the only plausible pathway is gene flow to conventionally cultivated maize varieties. However, gene flow is a natural and common process among different maize species and varieties. MIR162 has also been approved for use as food and feed in Viet Nam since 2014. Therefore, gene flow from MIR162 maize to cultivated maize varieties does not increase risks to the environment, biodiversity, or human and animal health (Section V.1). Consequently, the implementation of gene flow management measures is not considered necessary.

MIR162 maize poses no risk of becoming a weed, persisting, or invading natural ecosystems because its agronomic characteristics and susceptibility to common maize pests and diseases are comparable to those of its non-transgenic counterpart. MIR162 maize does not possess weedy traits, such as seeds capable of extensive dispersal or long-term persistence in soil, nor does it exhibit superior growth or competitive advantages that would enable it to become invasive (Section V.2).

The cultivation of MIR162 maize affects non-target organisms in a manner similar to conventional maize cultivation.

Environmental and biodiversity risk assessment trials conducted under field conditions in Viet Nam showed that MIR162 maize did not alter species composition, frequency of occurrence, diversity, or evenness of non-target arthropod communities, nor did it affect the population dynamics of sap-sucking pests and predatory natural enemies in maize fields, except for the target lepidopteran pests (Section V.3.2.2).

International exposure assessment studies have likewise reported no adverse effects of MIR162 maize on key non-target organisms compared with non-transgenic maize (Section V.3.2.1). Furthermore, MIR162 maize has not been reported to pose risks to wildlife species.

MIR162 maize does not alter existing cultivation practices in Viet Nam. Apart from its ability to control certain lepidopteran pests, all other agronomic characteristics of MIR162 maize are comparable to those of conventional maize varieties. Therefore, cultivation of MIR162 maize is essentially the same as cultivation of conventional maize varieties (Section V.4).

No adverse effects of MIR162 maize on soil organisms have been observed. Under Vietnamese trial conditions, no statistically significant differences were found between MIR162 maize and its non-transgenic counterpart with respect to the composition, abundance, diversity, or evenness of Collembola (springtail) populations (Sections V.5 and V.3).

In addition, studies conducted in other countries have reported no impacts of MIR162 maize on soil fauna, soil microorganisms, or soil biochemical cycles (Section V.5).

The development of resistance in lepidopteran pests to MIR162 maize is a possible risk. The likelihood of resistance development depends on the characteristics of the transformation event, the biological traits of the target insects, and cultivation practices. To minimize this risk, Syngenta will implement a structured refuge strategy at a ratio of 95:5 through seed mixtures involving maize containing two insect-resistance genes with different modes of action, beginning from the first year of commercial cultivation of MIR162 maize in Viet Nam.

MIR162 maize and products derived from MIR162 maize are as safe for humans and animals as conventional maize products. Analyses of the composition and nutritional content of MIR162 maize demonstrated equivalence to its non-transgenic comparator. MIR162 maize is not toxic, allergenic, or pathogenic to humans or animals.

MIR162 maize has been granted approval for use as food and feed in Viet Nam and in 25 countries worldwide, including Viet Nam (Section VI).

During the environmental release and commercialization of genetically modified maize event MIR162 in Viet Nam and other countries, should any new scientific evidence emerge indicating risks to environmental safety or to human and animal health, the company will immediately notify the competent government authorities and undertake appropriate measures, including corrective actions, to address any identified adverse effects.