Board for the Authorisation of Plant Protection Products and Biocides

Zonal Application (NL=zRMS) 

For the evaluation of national applications for product authorisation of plant protection products, the PPPR 1107/2009 introduced a zonal system. This system encourages cooperation and worksharing between Member States.

The regulation defines 3 zones based on the comparability of the agricultural, phytosanitary and ecological (including climatological) conditions: North, Central and South. The Netherlands is in the Central zone. For climate independent uses (e.g. indoor uses, seed treatment) the zonal partition is not used. For these uses all member states cooperate (“interzonal assessment”).

A company that wishes to place a plant protection product on the market in any EU member State, will first have to ensure that the active substance is approved, and submit a zonal application together with a complete dossier consisting of an active substance dossier for the active substances contained in the product and a product dossier to a Member State of his own choice. This member state will act as the reporting Member State (RMS). The RMS conducts a risk assessment based on active substance data and product data, the proposed instructions for use. The RMS takes a decision to grant or refuse the product authorisation applied for.

Companies can apply for product registration in other Member States at the same time an application for  product registration is assessed by the Rapporteur memberstate.  An application for authorisation of the product is submitted in a concerned memberstate (cMS), referring to the assessment that is carried out by the RMS  (an application in concerned Member State).

An application for registration can be submitted at any point after the zonal application for initial authorisation has been granted in a RMS (mutual recognition).

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