Mutual recognition – A time saving approach

Date: 7 May 2020

Placing a plant protection product (PPP) on the market is a very time and cost consuming procedure. Thus, the REGULATION (EC) No 1107/2009 provides a more efficient system – the mutual recognition (MR). Thoughts behind this system are that an authorization already granted in one Member State (MS) can be used for the authorization in another MS. This is based on the assumption that any assessment already done by one MS shall not be repeated by another MS, except for clearly defined issues.

The procedure for MR is clearly described in Article 40-42 of REGULATION (EC) No 1107/2009 and under point 3 of SANCO/13169/2010. There are three situations for which MR is possible or can be applied for, respectively, with the prerequisite that the reference authorization needs to have been granted in accordance with Article 29 REGULATION (EC) No 1107/2009:

  1. Authorizations between MSs belonging to the same zone
  2. Authorizations between MSs belonging to different zones with the provision that this authorization is not used for mutual recognition in another MS within the same zone (avoiding a “domino effect”)
  3. Authorizations between any MS where the application concerns use in greenhouse, post-harvest treatment, treatment of empty rooms or containers used for storing plants/plant products or seed treatment

Additionally, a number of cases are described for which MR is optional (Article 41.2), e.g. PPP contains a substance, which is included in the list of candidate for substitution, or the application concerns a provisional authorization, or the application concerns a product containing an active substance for which there are no alternatives (i.e. derogation according to Article 4.7). Further special cases are low-risk products or the extension of a minor use from one MS in another MS under the precondition that the product has a regular authorization in both MS.

The difference between the zonal evaluation and MR is that although in both cases the MSs have 120 days after completion of the zonal RMS evaluation to decide on authorization or refusal, the submission of the dossier for MR is not bound to the submission date to the zonal RMS. Additionally and in accordance with Article 36.3 of REGULATION (EC) No 1107/2009, the assessment of the MS shall be focused on “its specific environmental or agricultural circumstances. MR only applies for the same already granted product with the same uses under comparable agricultural conditions. Whilst there may be some flexibility to accept slight chances, more significant changes within an application would be dealt with as new zonal approach.

Sandra Rollar