Registration process

The Regulation provides for a system of mutual recognition, built on the assumption that the assessment done by one Member State shall not be repeated by other MSs when recognising an authorisation, except for clearly defined (national specific) circumstances.

For mutual recognition the principles applied are the same as those outlined for zonal authorizations in the concerned MS. An important difference between the zonal evaluation(NL=CMS) and the mutual recognition is the absence of a commentary round directly preceedig the mutual recognition. ((c)MS have had the opportunity to comment on the draft registration report during the zonal assessment procedure for that application).

Timeline Mutual Recognition

Tijdlijn wederzijdse erkenning gewasbeschermingsmiddelen

Tiijdlijn zonale aanvraag zRMS

Mutual Recognition

When an authorisation is issued in a Member State and the applicant wishes to place the same product on the market in (an)other Member State(s), an application is made for ‘mutual recognition’ of the product in the concerned Member State. Member States have a period of 120 days to decide on an application for mutual recognition.

After authorisation of a plant protection product under the PPPR 1107/2009, this registration and it’s registration report can be used to put this product on the market in other Member States in the zone through mutual recognition. The process does not include a commentary round with concerned MSs. All requested uses must fall under the risk envelope, as evaluated in the RR. Consequently, it is not possible to add additional uses to the application if these were not assessed in the RR.

In cases where a MS clearly identified specific national requirements (differing from or extending the core assessment), these national requirements should be taken into account by the applicant by submission for the application for mutual recognition in the format of national addenda to the dRR.

The core assessments (and national addenda where appropriate) are then used to define the safe uses that comply with the requirements for authorisation. Risk mitigation measures and other restrictions or conditions may be imposed in the authorisation, due to specific conditions of use (environmental or agricultural) in that MS.