Agrochemicals | Background

In the EU the placing on the market of plant protection products is currently regulated by Directive 91/414/EC which will be replaced on 14/06/2011 by regulation (EC) 1107/2009.

The precondition for national authorisations of pesticides in any EU member state is the inclusion of the active ingredient in Annex I of the EU directive 91/414 which will be transferred into the new regulation (EC) 1107/2009 on the key date.

For the current stage of the Annex I listing of existing and new active substances please refer to the EU-pesticides database.

Once an active substance is listed on Annex I of Directive 91/414/EC (respectively in the replacing law (EC) 1107/2009), plant protection products have to be authorised on national level. When regulation EC 1107/2009 is valid, product authorisations will be handled via zonal applications. The EU countries are devided in three zones (North, Central, and South). Basically, this approach envisages that a zonal rapporteur member state (zRMS) evaluates the application for a product registration for all countries of a zone where authorisation is sought. A zonal application consists of a core dossier for each concerned zone and national addenda containing country specific requirements. Other concerned MS (cMS) of the same zone will adopt the results of the evaluation for the core dossier and merely evaluate the national addenda.