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Report no: 2014: 19
The Norwegian Scientific Committee for Food Safety has conducted an assessment of possible health risk related to groundwater contamination with a metabolite of an active substance in the new fungicide Aviator Xpro EC 225..
VKM concludes that the available studies are insufficient to conclude that the metabolite is without genotoxic activity, and that studies in rabbit may suggest that the metabolite is capable of inducing foetal malformations.
Aviator Xpro EC 225 is a new fungicide for use in cereals with the new active substance bixafen and the already approved substance prothioconazole.
Prothioconazole was assessed by the Norwegian Scientific Committee for Food Safety (VKM) in 2006, and bixafen in in the spring of 2013.
In its assessment of bixafen, VKM concluded that a metabolite of bixafen, M44, has potential for groundwater contamination. Thus, VKM was asked by the Norwegian Food Safety Authority to assess the health risk related to this metabolite.
In general, VKM is concerned with pesticides where ingredients or metabolites are capable of reaching and contaminating groundwater. This concern is relevant for one of the active ingredients in Aviator Xpro EC 22, bixafen, via its metabolite M44.
Metabolites with the ability to contaminate groundwater are evaluated in accordance with a specific guidance document under Council Directive 91/414/EEC. In a tiered manner a number of questions must be answered to form the basis for the final decision on whether to accept or turn down an application.
VKM concluded that the presented data from in vitro experiments do not provide the necessary assurance that the bixafen metabolite M44 is without genotoxic activity since no data from in vivo testing has been presented.
Furthermore, it is the opinion of VKM that the reported foetal malformations in rabbits should be considered relevant for humans.