Characteristics

Plant protection products are authorised at the national level. One member state acting as the so-called zonal Rapporteur Member State (zRMS) is responsible for conducting the assessments and preparing a comprehensive assessment report (draft Registration Report, dRR), which is then given to the other concerned member states (cMS) for comment. The zRMS finalises the Registration Report (RR) under consideration of the comments received. The finalised RR then forms the basis for product authorisation in the zRMS and the subsequent recognition of the product authorisation in the cMS.

On national level the basic zonal assessment (core assessment) can be extended with complementing assessments for national aspects. Specific national aspects have been established for the Netherlands. Also some specific technical and agronomic circumstances and common practices can be of influence on the dossier preparation and assessment.

Recognition can run in parallel to the evaluation and authorisation by the zRMS, as is the case in the procedure for zonal application with recognition in concerned MS’s. Alternatively, the recognition can run in sequence of the authorisation by the zRMS, as is the case in the procedure for mutual recognition.
Requirements and legislative framework for the zonal application for concerned MS’s and the application for mutual recognition strongly correspond. The mutual recognition can be regarded as a zonal application (NL=CMS) without commentary round.

The legal basis

The zonal application finds its legal basis in article 28-36 of the PPPR (EC) No 1107/2009.

• For zonal applications (NL=cMS) reference is made to art.28 and art.36(3) of Regulation 1107/2009;
• For mutual recognition applications reference is made to art.40 of the regulation.

Application type criteria

The zonal procedure applies for:

• new authorisations,
• major amendments to existing authorisations:
  • extending (the scope of) the authorisation;
  • major changes in product composition,

Prior condition for a zonal application of a plant protection product requires that:

• its active substances, safeners and synergists have been approved art.29 of the regulation
  
  If the active substance is approved but classified as a Candidate for Substitution, a product application with this active substance will be preceeded by an evaluation of available alternatives. Therefore you have to include the form for a Comparative Assessment.
  
  Search status active substance in EU pesticides database
• for use on feed or food crops, an MRL has been published in the EU that covers the requested use.
  
  Search published MRL’s in EU pesticide database

The applications are evaluated according the procedures defined in Regulation (EC) No. 1107/2009 and follow the zonal procedure.

Data requirements

Data requirements for an application depends on the date of submission of that application. An actual overview of data requirements applicable for a specified date of submission, can be selected by the filter in the right-hand column. Filtering on the keyword ‘data requirements’, an aspired ‘date of submission’ of ‘1-5-2016’ and ‘Wet- en regelgeving’ as ‘Type toetsingskader’ gives as a result: Regulation No 283/2013 and 284/2013 as the applicable data requirements for the approval of active substances and the authorisation of plant protection products.

Please note that the dossier structure should follow the Table of Contents (ToC) and numbering set by the data requirements. Electronic submission of dossiers (application form, dRR, study summaries and reports) should be presented in CADDY.

Duration Period Product Authorisation

An authorisation will be granted for a period not exceeding 1 year from the date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product (art.32 of regulation 1107/2009).

Coordination zonal applications: Central Zone Steering Committee

The czSC is a co-ordination body dealing with issues of work-sharing (which is seen to be the key function of the group). Within the Central Zone Steering Committee (czSC) agreements are made to achieve effective and harmonised cooperation on zonal applications. The czSC does not address questions on product specific risk assessments.

The activities of czSC generally does not effect the procedures of the zonal application for concerned MS and those for mutual recognition.