Aviator Xpro EC 225 is a new fungicide for use in cereals, containing the active substance bixafen and the already approved substance prothioconazole.

Risk assessment

This risk assessment is based on recognized international methodology and documentation from a large number of experimental studies.

The documentation is in part submitted by the pesticide notifier, supplemented with peer reviewed literature. The conclusions in the assessment will be used by the Norwegian Food Safety Authority when considering the application for registration of Aviator Xpro EC 225 in Norway.

VKM was asked to assess possible health risk, fate and behavior in the environment, as well as eco-toxicological effects and risks related to the properties and use of Aviator Xpro EC 225.

Health

VKM concludes that effects on liver and coagulating parameters observed in experimental animals exposed to bixafen should be considered relevant for humans. The data do no suggest a tumour inducing potential of bixafen.

However, VKM is of the opinion that it cannot be excluded that bixafen may have a potential for teratogenic effects. Safety may therefore depend on the use of protective equipment.

Environment

It is the opinion of VKM that repeated application of Aviator Xpro EC 225 may cause accumulation of bixafen in soil, and that there is also a potential for groundwater contamination from a metabolite.

Bixafen has minimal risk for toxic effects to terrestrial organisms, but may have toxic effects on aquatic organisms unless a safety zone of 10 m to open water are used.