Plant protection products containing active substances that are included on the Annex I of Regulation 1107/2009 (used to be Directive 91/414), still need an application in each member state. It is possible to apply for ‘zonal’ applications: North, Center and South have been divided by Regulation 1107 and it is possible to apply in only one member state followed by mutual recognitions at a later time. BReTox can advise you on the procedures. The product dossier needs to be prepared in dRR format. BReTox can assist you with the preparation of such a product dossier.
Plant protection products containing active substance(s) that are still under review and not yet included on the list, still follow national application procedures. BReTox has ample experience with applications in the Netherlands to the Ctgb.
An active substance that is on the Annex I list needs a renewal after 10 years. BReTox has experience with the preparation of these Annex I renewal (AIR) dossier.
BReTox can perform the operator/worker/bystander/resident exposure and risk assessment, as well as the dietary exposure and risk assessment, according to the latest EFSA models.